Shape memory implants and methods and apparatus for the loading and implanting thereof

An orthopedic fixation system includes an implant and an implant insertion device. The implant transitions between a natural shape and an insertion shape and includes a bridge and first and second anchoring members extending from the bridge. The first and second anchoring members each include a segment extending exterior to the bridge to provide an engagement point. The implant insertion device moves between loaded and unloaded positions. The implant insertion device in its loaded position by-passes the bridge and engages the segment of the first anchoring member at its engagement point and the segment of the second anchoring member at its engagement point such that the implant insertion device constrains the implant in its insertion shape. The implant insertion device in its unloaded position releases the implant.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to shape memory implants and the implantation thereof using an implantation device and, more particularly, but not way of limitation, to an orthopedic fixation system including a shape memory implant and an implantation device designed for loading with the shape memory implant and for subsequent delivery of the shape memory implant utilizing the implantation device.

2. Description of the Related Art

Shape memory implants are commonly used in surgical procedures that require the reattachment or fusing of tissue or bone. Shape memory implants can be composed of a shape memory material such as Nitinol that allows the shape memory implants to have a first final shape and the ability to transform into a second shape. A shape memory implant can be either thermally activated, in which an external heating source or body temperature would be required to activate the implant, or mechanically activated, in which a constraining instrument would be required. A shape memory implant that requires mechanical constraint stores mechanical energy due to elastic recovery, and then releases the stored mechanical energy when the constraining instrument is removed. In these types of implants, the implants are mechanically moved into their second shape and maintained in their second shape by instrumentation such that, upon release from the instrumentation, the implants elastically return from their second shape into their first final shape.

In surgical procedures, the elastic property of constrained shape memory implants is used as follows. Bones that require fixating are aligned, and the shape memory implant, which has been mechanically deformed to its second shape, is maintained in instrumentation and inserted across the bones. After insertion, the shape memory implant is released from the instrumentation, whereupon the shape memory implant elastically tries to return to its first final shape such that the shape memory implant maintains the bones fixated together. The shape memory implant because it stores mechanical energy continuously applies force to the fixated bones as the shape memory implant tries to transition from the second shape to the first final shape, which aids in the healing process.

Various types of instrumentation can be used for either maintaining the shape memory implants in their second shape or moving an implant from its first final shape to a temporary second shape. Some companies used metal forceps to open and insert the shape memory implant. These forceps have to be sterilized by a hospital, and then a shape memory implant can be placed on the forceps, opened to a desired position, and used for inserting the implant. Although potentially effective, forceps require the implant to be loaded into the forceps during surgery, which might be cumbersome and time consuming. In addition, forceps might be large which could hinder implantation of the shape memory implant into a patient during surgery. It is also possible that a physician using the forceps might damage the shape memory implant in various ways, such as stretching the implant beyond the second shape, fatiguing the implant, or causing metal-on-metal scraping of the implant with the instrument. Furthermore, forceps can be expensive instruments that require cleaning and sterilization after each surgery.

Other instrumentation includes plastic and disposable tools to maintain a shape memory implant in the second shape. This type of instrumentation can be preloaded and sterilized with the implant already in the second shape, and the implant can be pre-activated so that it does not require heating with an external heater or body temperature after use. One type of plastic and disposable instrument operates by having the implant fit inside a passage that is substantially the same diameter as the shape memory implant. By using this method, the instrumentation allows the shape memory implant to be preloaded prior to surgery. However, using instrumentation that substantially conforms to the profile of the shape memory implant can create several problems for a surgeon. First, this type of instrumentation often makes disengagement of the shape memory staple after implantation problematic. In particular, the shape memory implant sticks to the instrumentation due to the frictional engagement between the shape memory implant, which is trying to compress, and the passage of the instrumentation, resulting in a more difficult surgical procedure and the potential for a less than satisfactory fixation of tissue or bone. Second, this type of instrumentation results in an abrupt and sudden release of stored mechanical energy as the implant is removed from the device. This type of instrumentation accordingly provides no method of slowly transitioning the stored energy in the implant from the instrumentation to the bones being fixated. Finally, this type of instrumentation can result in entanglement during release, in which the implant begins to compress upon release thereby making extraction of this type of instrumentation more difficult.

Another type of plastic and disposable instrument includes arms movable between a disengaged position and an engaged position. The arms terminate in jaws such that, when the arms reside in their engaged position, the jaws contact the shape memory implant to maintain the shape memory implant open for insertion. While the movable arms and jaws release the implant without entanglement and further allow the slow transitioning of the implant, the jaws, due to their location when contacting the shape memory implant as well as their path of travel during removal from the shape memory implant, leave the implant situated above the bone surface such that tamping of the implant to a position flush with the bone surface is required. As a result, the instrument can be impractical for certain surgeries because it is not always possible to tamp and thus seat the implant flush with a bone surface after its release from the instrument, particularly when the implant includes anchoring members of limited length.

Accordingly, an instrument that constrains a shape memory implant in its second shape, allows the shape memory implant to be preloaded and sterilized prior to surgery, controls the rate of tension release, simplifies removal of the shape memory implant after implantation, and releases the shape memory implant at a bone surface thereby eliminating tamping would be beneficial.

SUMMARY OF THE INVENTION

In accordance with the present invention, an orthopedic fixation system includes an implant and an implant insertion device. The implant transitions between a natural shape and an insertion shape. The implant insertion device moves between a loaded position that constrains the implant in its insertion shape and an unloaded position that releases the implant for attempted transition from its insertion shape to its natural shape. More particularly, the implant insertion device, when loading with the implant, by-passes a bridge of the implant and engages a segment of a first anchoring member for the implant at an engagement point and a segment of a second anchoring member for the implant at an engagement point such that the implant insertion device constrains the implant in its insertion shape.

The implant insertion device includes a body with a first end and a second end and an implant grip coupled with the body. The implant grip moves relative to the body between an engaged position and a disengaged position. The implant grip in its engaged position by-passes the bridge and engages the segment of the first anchoring member at its engagement point and the segment of the second anchoring member at its engagement point such that the implant grip constrains the implant in its insertion shape. The implant grip in its disengaged position releases the implant.

The implant in the present invention includes a bridge with first and second sides and first and second ends and anchoring members extending from the bridge in accordance with the following configurations. The implant in a first configuration includes a first anchoring member extending from the bridge at the first end thereof and a second anchoring member extending from the bridge at the second end thereof. The first anchoring member includes a width between sides thereof whereby a first segment extends exterior to the bridge at its first side to provide a first engagement point and a second segment extends exterior to the bridge at its second side to provide a second engagement point. The second anchoring member includes a width between sides thereof whereby a first segment extends exterior to the bridge at its first side to provide a first engagement point and a second segment extends exterior to the bridge at its second side to provide a second engagement point.

The implant in a second configuration includes a first anchoring member extending from the bridge at the first end of the bridge adjacent the first side of the bridge, a second anchoring member extending from the bridge at the second end thereof, and a third anchoring member extending from the bridge at the first end of the bridge adjacent the second side of the bridge. The first anchoring member includes a width between sides thereof whereby a segment of the first anchoring member extends exterior to the bridge at its first side to provide and engagement point. The second anchoring member includes a width between sides thereof whereby a first segment extends exterior to the bridge at its first side to provide a first engagement point and a second segment extends exterior to the bridge at its second side to provide a second engagement point. The third anchoring member includes a width between sides thereof whereby a segment of the third anchoring member extends exterior to the bridge at its second side to provide an engagement point.

The implant in a third configuration includes a first anchoring member extending from the bridge at the first end of the bridge adjacent the first side of the bridge, a second anchoring member extending from the bridge at the second end of the bridge adjacent the first side of the bridge, a third anchoring member extending from the bridge at the first end of the bridge adjacent the second side of the bridge, and a fourth anchoring member extending from the bridge at the second end of the bridge adjacent the second side of the bridge. The first anchoring member includes a width between sides thereof whereby a segment of the first anchoring member extends exterior to the bridge at its first side to provide an engagement point. The second anchoring member includes a width between sides thereof whereby a segment of the second anchoring member extends exterior to the bridge at its first side to provide an engagement point. The third anchoring member includes a width between sides thereof whereby a segment of the third anchoring member extends exterior to the bridge at its second side to provide an engagement point. The fourth anchoring member includes a width between sides thereof whereby a segment of the fourth anchoring member extends exterior to the bridge at its second side to provide an engagement point.

The implant insertion device for use with an implant having first and second anchoring members includes a body with a first end and a second end and an implant grip coupled with the body at its second end. The implant grip moves relative to the body between an engaged position and a disengaged position. The implant grip in its engaged position by-passes the bridge and engages the first and second segments of the first anchoring member at their first and second engagement points and the first and second segments of the second anchoring member at their first and second engagement points such that the implant grip constrains the implant in its insertion shape. The implant grip in its disengaged position releases the implant.

The implant grip includes a shell coupled with the body. The shell includes an exterior surface having an upper surface and a lower surface. The shell further includes an interior surface complimentary in shape with the implant such that the interior surface defines a passage through the shell complimentary in shape with the implant. The shell at its upper surface receives into the passage the body at its second end thereby coupling the shell with the body. The shell at its lower surface receives into the passage the implant. When receiving the implant, the shell at its interior surface by-passes the bridge and engages the first and second segments of the first anchoring member at their first and second engagement points and the first and second segments of the second anchoring member at their first and second engagement points thereby holding the implant in the shell and constraining the implant in its insertion shape.

The interior surface of the shell defines first, second, third, and fourth grooves. When the shell at its interior surface by-passes the bridge, each of the first, second, third, and fourth grooves receives therein one of the first and second segments of the first and second anchoring members. Moreover, the interior surface at the first, second, third, and fourth grooves engages the first and second anchoring members, thereby retaining the implant within the shell in its insertion shape. The interior surface in each of the first, second, third, and fourth grooves further defines a retention surface. When the first, second, third, and fourth grooves receive therein one of the first and second segments of the first and second anchoring members, each of the retention surfaces abuts one of the first and second engagement points of the first and second segments for the first and second anchoring members. The retention surfaces accordingly grip and constrain the first and second anchoring members such that the shell retains therein the implant in its insertion shape.

The body of the implant insertion device includes an implant grip receiver at the second end thereof that terminates in a tamp. The implant grip receiver is complimentary in shape with the interior surface of the shell such that the implant grip receiver inserts into the passage of the shell at its upper surface thereby coupling the implant grip receiver with the shell. When the implant grip resides in its engaged position, the tamp sits atop the bridge of the implant. Moreover, the tamp remains atop the bridge of the implant to prevent movement of the implant relative to the implant grip during progression of the implant grip from its engaged position to its disengaged position.

The implant grip receiver includes a first notch and a second notch, while the interior surface of the shell includes a detent engageable with the first and second notches. When the implant grip moves to its engaged position, the detent engages the first notch thereby locking the implant grip in its engaged position. Alternatively, when the implant grip moves to its disengaged position, the detent engages the second notch thereby locking the implant grip in its disengaged position.

The implant grip in an alternative embodiment of the implant insertion device includes an actuator coupled with the body and movable relative thereto whereby movement of the actuator progresses the implant grip between its engaged and disengaged positions. The implant grip further includes first and second blades securable with the actuator in an opposed relationship that defines a passage therebetween. The passage receives therein the bridge of the implant such that the first and second blades extend beyond the bridge and engage the first and second segments of the first and second anchoring members at their first and second engagement points thereby holding the implant and constraining the implant in its insertion shape. The actuator includes a first slider, a second slider, and a spacer. The first slider secures with the first blade, whereas the second slider secures with the second blade. The spacer secures between the first and second sliders such that the first and second blades are spaced apart to form the passage therebetween.

The body in an alternative embodiment of the implant insertion device defines a tamp at its second end. The body further defines a slot therethrough communicating exterior to the body that receives the spacer therein. The first slider secures with the spacer adjacent a first surface of the body, while the second slider secures with the spacer adjacent a second surface of the body. The first and second blades extend beyond the tamp such that the passage between the first and second blades is located adjacent the tamp. When the implant grip resides in its engaged position, the tamp sits atop the bridge of the implant. Moreover, the tamp remains atop the bridge of the implant to prevent movement of the implant relative to the implant grip during progression of the implant grip from its engaged position to its disengaged position.

The implant insertion device for use with an implant having first, second, and third anchoring members includes a body with a first end and a second end and an implant grip coupled with the body at its second end. The implant grip moves relative to the body between an engaged position and a disengaged position. The implant grip in its engaged position by-passes the bridge and engages the segments of the first and third anchoring members at their engagement points and the first and second segments of the second anchoring member at their first and second engagement points such that the implant grip constrains the implant in its insertion shape. The implant grip in its disengaged position releases the implant.

The implant grip includes a shell coupled with the body. The shell includes an exterior surface having an upper surface and a lower surface. The shell further includes an interior surface complimentary in shape with the implant such that the interior surface defines a passage through the shell complimentary in shape with the implant. The shell at its upper surface receives into the passage the body at its second end thereby coupling the shell with the body. The shell at its lower surface receives into the passage the implant. When receiving the implant, the shell at its interior surface by-passes the bridge and engages the segments of the first and third anchoring members at their engagement points and the first and second segments of the second anchoring member at their first and second engagement points thereby holding the implant in the shell and constraining the implant in its insertion shape.

The interior surface of the shell defines first, second, third, and fourth grooves. When the shell at its interior surface by-passes the bridge, each of the first, second, third, and fourth grooves receives therein one of the segments of the first and third anchoring members and the first and second segments of the second anchoring member. Moreover, the interior surface at the first, second, third, and fourth grooves engages the first, second, and third anchoring members, thereby retaining the implant within the shell in its insertion shape. The interior surface in each of the first, second, third, and fourth grooves further defines a retention surface. When the first, second, third, and fourth grooves receive therein one of the segments of the first and third anchoring members and the first and second segments of the second anchoring member, each of the retention surfaces abuts one of the engagement points of the segments for the first and third anchoring members and the first and second engagement points of the first and second segments for the second anchoring member. The retention surfaces accordingly grip and constrain the first, second, and third anchoring members such that the shell retains therein the implant in its insertion shape.

The interior surface of the shell includes projections that may be resilient. When the shell at its interior surface by-passes the bridge, the projections also by-pass the bridge and engage one of the first and third anchoring members such that the shell retains therein the implant in its insertion shape. The projections when they are resilient by-pass the bridge by moving relative thereto and engage one of the first and third anchoring members such that the shell retains therein the implant in its insertion shape.

The body of the implant insertion device includes an implant grip receiver at the second end thereof that terminates in a tamp. The implant grip receiver is complimentary in shape with the interior surface of the shell such that the implant grip receiver inserts into the passage of the shell at its upper surface thereby coupling the implant grip receiver with the shell. When the implant grip resides in its engaged position, the tamp sits atop the bridge of the implant. Moreover, the tamp remains atop the bridge of the implant to prevent movement of the implant relative to the implant grip during progression of the implant grip from its engaged position to its disengaged position.

The implant grip receiver includes a first notch and a second notch, while the interior surface of the shell includes a detent engageable with the first and second notches. When the implant grip moves to its engaged position, the detent engages the first notch thereby locking the implant grip in its engaged position. Alternatively, when the implant grip moves to its disengaged position, the detent engages the second notch thereby locking the implant grip in its disengaged position.

The implant grip in an alternative embodiment of the implant insertion device includes an actuator coupled with the body and movable relative thereto whereby movement of the actuator progresses the implant grip between its engaged and disengaged positions. The implant grip further includes first and second blades securable with the actuator in an opposed relationship that defines a passage therebetween. The passage receives therein the bridge of the implant such that the first and second blades extend beyond the bridge and engage the segments of the first and third anchoring members at their engagement points and the first and second segments of the second anchoring member at their first and second engagement points thereby holding the implant and constraining the implant in its insertion shape. The actuator includes a first slider, a second slider, and a spacer. The first slider secures with the first blade, whereas the second slider secures with the second blade. The spacer secures between the first and second sliders such that the first and second blades are spaced apart to form the passage therebetween.

The body in an alternative embodiment of the implant insertion device defines a tamp at its second end. The body further defines a slot therethrough communicating exterior to the body that receives the spacer therein. The first slider secures with the spacer adjacent a first surface of the body, while the second slider secures with the spacer adjacent a second surface of the body. The first and second blades extend beyond the tamp such that the passage between the first and second blades is located adjacent the tamp. When the implant grip resides in its engaged position, the tamp sits atop the bridge of the implant. Moreover, the tamp remains atop the bridge of the implant to prevent movement of the implant relative to the implant grip during progression of the implant grip from its engaged position to its disengaged position.

The implant insertion device for use with an implant having first, second, third, and fourth anchoring members includes a body with a first end and a second end and an implant grip coupled with the body at its second end. The implant grip moves relative to the body between an engaged position and a disengaged position. The implant grip in its engaged position by-passes the bridge and engages the segments of the first, second, third, and fourth anchoring members at their engagement points such that the implant grip constrains the implant in its insertion shape. The implant grip in its disengaged position releases the implant.

The implant grip includes a shell coupled with the body. The shell includes an exterior surface having an upper surface and a lower surface. The shell further includes an interior surface complimentary in shape with the implant such that the interior surface defines a passage through the shell complimentary in shape with the implant. The shell at its upper surface receives into the passage the body at its second end thereby coupling the shell with the body. The shell at its lower surface receives into the passage the implant. When receiving the implant, the shell at its interior surface by-passes the bridge and engages the segments of the first, second, third, and fourth anchoring members at their engagement points thereby holding the implant in the shell and constraining the implant in its insertion shape.

The interior surface of the shell defines first, second, third, and fourth grooves. When the shell at its interior surface by-passes the bridge, each of the first, second, third, and fourth grooves receives therein one of the segments of the first, second, third, and fourth anchoring members. Moreover, the interior surface at the first, second, third, and fourth grooves engages the first, second, third, and fourth anchoring members, thereby retaining the implant within the shell in its insertion shape. The interior surface in each of the first, second, third, and fourth grooves further defines a retention surface. When the first, second, third, and fourth grooves receive therein one of the segments of the first, second, third, and fourth anchoring members, each of the retention surfaces abuts one of the engagement points of the segments for the first, second, third, and fourth anchoring members. The retention surfaces accordingly grip and constrain the first, second, third, and fourth anchoring members such that the shell retains therein the implant in its insertion shape.

The interior surface of the shell includes projections that may be resilient. When the shell at its interior surface by-passes the bridge, the projections also by-pass the bridge and engage one of the first, second, third, and fourth anchoring members such that the shell retains therein the implant in its insertion shape. The projections when they are resilient by-pass the bridge by moving relative thereto and engage one of the first, second, third, and fourth anchoring members such that the shell retains therein the implant in its insertion shape.

The body of the implant insertion device includes an implant grip receiver at the second end thereof that terminates in a tamp. The implant grip receiver is complimentary in shape with the interior surface of the shell such that the implant grip receiver inserts into the passage of the shell at its upper surface thereby coupling the implant grip receiver with the shell. When the implant grip resides in its engaged position, the tamp sits atop the bridge of the implant. Moreover, the tamp remains atop the bridge of the implant to prevent movement of the implant relative to the implant grip during progression of the implant grip from its engaged position to its disengaged position.

The implant grip receiver includes a first notch and a second notch, while the interior surface of the shell includes a detent engageable with the first and second notches. When the implant grip moves to its engaged position, the detent engages the first notch thereby locking the implant grip in its engaged position. Alternatively, when the implant grip moves to its disengaged position, the detent engages the second notch thereby locking the implant grip in its disengaged position.

The implant grip in an alternative embodiment of the implant insertion device includes an actuator coupled with the body and movable relative thereto whereby movement of the actuator progresses the implant grip between its engaged and disengaged positions. The implant grip further includes first and second blades securable with the actuator in an opposed relationship that defines a passage therebetween. The passage receives therein the bridge of the implant such that the first and second blades extend beyond the bridge and engage the segments of the first, second, third, and fourth anchoring members at their engagement points thereby holding the implant and constraining the implant in its insertion shape. The actuator includes a first slider, a second slider, and a spacer. The first slider secures with the first blade, whereas the second slider secures with the second blade. The spacer secures between the first and second sliders such that the first and second blades are spaced apart to form the passage therebetween.

The body in an alternative embodiment of the implant insertion device defines a tamp at its second end. The body further defines a slot therethrough communicating exterior to the body that receives the spacer therein. The first slider secures with the spacer adjacent a first surface of the body, while the second slider secures with the spacer adjacent a second surface of the body. The first and second blades extend beyond the tamp such that the passage between the first and second blades is located adjacent the tamp. When the implant grip resides in its engaged position, the tamp sits atop the bridge of the implant. Moreover, the tamp remains atop the bridge of the implant to prevent movement of the implant relative to the implant grip during progression of the implant grip from its engaged position to its disengaged position.

The implant of the present invention with anchoring members extending from a bridge may be implanted through the use of drill holes created in bone, bones, or bone pieces. Moreover, it is often preferable to introduce the implant into the bone, bones, or bone pieces proximate to a fixation device holding the bone, bones, or bone pieces in a desired alignment. In order to permit such an implantation, a drill guide in various embodiments is configured for the drilling of drill holes into bone, bones, or bone pieces proximate to a fixation device.

The drill guide in one embodiment includes a body with first and second passages therethrough and a third passage and a fourth passage therethrough in alternative embodiments thereof. The drill guide includes a grip extending from the body and a template depending from the body between the first and second passages. The template includes a slot whereby the first passage resides exterior to the slot adjacent a first side thereof and the second passage resides exterior to the slot adjacent a second side thereof. In addition, a distance between the first and second passages substantially equals a distance between a first anchoring member of an implant and a second anchoring member of the implant when the implant resides in an insertion shape plus a distance equal to a thickness of the template.

A placement of the body on bone, bones, or bone pieces using the grip introduces the template at a fusion zone of the bone, bones, or bone pieces such that the slot receives therein a fixation device inserted into the bone, bones, or bone pieces. With the template at the fusion zone and the fixation device in the slot, the first passage resides on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate a first side of the fixation device and the second passage resides on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate a second side of the fixation device. Upon a drilling of drill holes in the bone, bones, or bone pieces using the first and second passages, the drill holes due to the positioning of the first and second passages on the bone, bones, or bone pieces are located proximate to the fixation device.

When the drill guide incorporates a third passage, the body includes the first passage therethrough located at a first end of the body adjacent a first side of the body, the second passage therethrough located at the first end of the body adjacent a second side of the body, and the third passage therethrough located at a second end of the body adjacent one of the first side of the body and the second side of the body. The drill guide includes the grip extending from the body and the template depending from the body between the first and second passages and the third passage. The template includes the slot whereby the first passage resides exterior to the slot adjacent the first side thereof, the second passage resides exterior to the slot adjacent the second side thereof, and the third passage resides exterior to the slot adjacent one of the first side thereof and the second side thereof. In addition, a distance between the first and second passages and the third passage substantially equals a distance between first and second anchoring members at a first end of an implant and a third anchoring member at a second end of the implant when the implant resides in an insertion shape plus a distance equal to a thickness of the template.

A placement of the body on bone, bones, or bone pieces using the grip introduces the template at a fusion zone of the bone, bones, or bone pieces such that the slot receives therein a fixation device inserted into the bone, bones, or bone pieces. With the template at the fusion zone and the fixation device in the slot, the first passage resides on the bone, bones, or bone piece adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the bone, bones, or bone piece adjacent the first side of the fusion zone proximate a second side of the fixation device, and the third passage resides on the bone, bones, or bone piece adjacent a second side of the fusion zone proximate one of the first side of the fixation device and the second side of the fixation device. Upon a drilling of drill holes in the bone, bones, or bone pieces using the first, second, and third passages, the drill holes due to the positioning of the first, second, and third passages on the bone, bones, or bone pieces are located proximate to the fixation device.

When the drill guide incorporates third and fourth passages, the body includes the first passage therethrough located at a first end of the body adjacent a first side of the body, the second passage therethrough located at the first end of the body adjacent a second side of the body, the third passage therethrough located at a second end of the body adjacent the first side of the body, and the fourth passage therethrough located at the second end of the body adjacent the second side of the body. The body includes the grip extending from the body the template depending from the body between the first and second passages and the third and fourth passages. The template includes the slot whereby the first and third passages reside exterior to the slot adjacent the first side thereof and the second and fourth passages reside exterior to the slot adjacent the second side thereof. In addition, a distance between the first and third passages and the second and fourth passages substantially equals a distance between first and second anchoring members at a first end of an implant and third and fourth anchoring members at a second end of the implant when the implant resides in an insertion shape plus a distance equal to a thickness of the template.

A placement of the body on bone, bones, or bone pieces using the grip introduces the template at a fusion zone of the bone, bones, or bone pieces such that the slot receives therein a fixation device inserted into the bone, bones, or bone pieces. With the template at the fusion zone and the fixation device in the slot, the first passage resides on the bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the bone adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the bone adjacent a second side of the fusion zone proximate the first side of the fixation device, and the fourth passage resides on the bone adjacent the second side of the fusion zone proximate the second side of the fixation device. Upon a drilling of drill holes in the bone, bones, or bone pieces using the first, second, third, and fourth passages, the drill holes due to the positioning of the first, second, third, and fourth passages on the bone, bones, or bone pieces are located proximate to the fixation device.

The drill guide in another embodiment includes a body with first and second passages therethrough and a third passage and a fourth passage therethrough in alternative embodiments thereof. The drill guide includes a first grip extending from the body adjacent the first passage and a first template depending from the first grip. The drill guide includes a second grip extending from the body adjacent the second passage and a second template depending from the second grip. The first and second templates each include a slot with first and second sides whereby the first passage resides exterior to the slots of the first and second templates at their first sides and the second passage resides exterior to the slots of the first and second templates at their second sides. In addition, a distance between the first and second passages substantially equals a distance between a first anchoring member of an implant and a second anchoring member of the implant when the implant resides in an insertion shape.

A placement of the body on bone, bones, or bone pieces across a fusion zone thereof using at least one of the first and second grips introduces the first template adjacent a first portion of the bone, bones, or bone pieces and the second template adjacent a second portion of the bone, bones, or bone pieces such that the slots of the first and second templates receive therein a fixation device inserted through the bone, bones, or bone pieces. With the first and second templates adjacent the bone, bones, or bone pieces and the fixation device in their respective slots, the first passage resides on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate a first side of the fixation device and the second passage resides on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate a second side of the fixation device. Upon a drilling of drill holes in the bone, bones, or bone pieces using the first and second passages, the drill holes due to the positioning of the first and second passages on the bone, bones, or bone pieces are located proximate to the fixation device.

When the drill guide incorporates a third passage, the body includes the first passage therethrough located at a first end of the body adjacent a first side of the body, the second passage therethrough located at the first end of the body adjacent a second side of the body, and the third passage therethrough located at a second end of the body adjacent one of the first side of the body and the second side of the body. The drill guide includes the first grip extending from the body adjacent the first and second passages and the first template depending from the first grip. The drill guide includes the second grip extending from the body adjacent the third passage and the second template depending from the second grip. The first and second templates each include the slot with first and second sides whereby the first passage resides exterior to the slots of the first and second templates at their first sides, the second passage resides exterior to the slots of the first and second templates at their second sides, and the third passage resides exterior to the slots of the first and second templates at one of their first sides and their second sides. In addition, a distance between the first and second passages and the third passage substantially equals a distance between first and second anchoring members at a first end of an implant and a third anchoring member at a second end of the implant when the implant resides in an insertion shape.

A placement of the body on bone, bones, or bone pieces across a fusion zone thereof using at least one of the first and second grips introduces the first template adjacent a first portion of the on bone, bones, or bone pieces and the second template adjacent a second portion of the on bone, bones, or bone pieces such that the slots of the first and second templates receive therein a fixation device inserted through the bone. With the first and second templates adjacent the bone, bones, or bone pieces and the fixation device in their respective slots, the first passage resides on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the bone, bones, or bone pieces adjacent the first side of the fusion zone proximate a second side of the fixation device, and the third passage resides on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate one of the first side of the fixation device and the second side of the fixation device. Upon a drilling of drill holes in the bone, bones, or bone pieces using the first, second, and third passages, the drill holes due to the positioning of the first, second, and third passages on the bone, bones, or bone pieces are located proximate to the fixation device.

When the drill guide incorporates third and fourth passages, the body includes the first passage therethrough located at a first end of the body adjacent a first side of the body, the second passage therethrough located at the first end of the body adjacent a second side of the body, the third passage therethrough located at a second end of the body adjacent the first side of the body, and the fourth passage therethrough the body located at the second end of the body adjacent the second side of the body. The drill guide includes the first grip extending from the body adjacent the first and second passages and the first template depending from the first grip. The drill guide includes the second grip extending from the body adjacent the third and fourth passages. The first and second templates each include the slot with first and second sides whereby the first and third passages reside exterior to the slots of the first and second templates at their first sides and the second and fourth passages reside exterior to the slots of the first and second templates at their second sides. In addition, a distance between the first and third passages and the second and fourth passages substantially equals a distance between first and second anchoring members at a first end of an implant and third and fourth anchoring members at a second end of the implant when the implant resides in an insertion shape.

A placement of the body on bone, bones, or bone pieces across a fusion zone thereof using at least one of the first and second grips introduces the first template adjacent a first portion of the bone, bones, or bone pieces and the second template adjacent a second portion of the bone, bones, or bone pieces such that the slots of the first and second templates receive therein a fixation device inserted through the bone, bones, or bone pieces. With the first and second templates adjacent the bone, bones, or bone pieces and the fixation device in their respective slots, the first passage resides on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the bone, bones, or bone pieces adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate the first side of the fixation device, and the fourth passage resides on the bone, bones, or bone pieces adjacent the second side of the fusion zone proximate the second side of the fixation device. Upon a drilling of drill holes in the bone, bones, or bone pieces using the first, second, third, and fourth passages, the drill holes due to the positioning of the first, second, third, and fourth passages on the bone, bones, or bone pieces are located proximate to the fixation device.

In accordance with a method for an orthopedic fixation system including the implant with first and second anchoring members extending from the bridge, an implant insertion device loads with the implant. The implant insertion device by-passes the bridge and engages the segment of the first anchoring member at its engagement point and the segment of the second anchoring member at its engagement point such that the implant insertion device constrains the implant in its insertion shape. The implant utilizing the implant insertion device is positioned with its first anchoring member at a first bone, its second anchoring member at a second bone, and its bridge spanning a fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first and second anchoring members while the implant insertion device is used to insert the first anchoring member into the first bone and the second anchoring member into the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first and second anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Loading the implant insertion device with the implant includes moving the implant grip relative to the body whereby the implant grip by-passes the bridge and engages the segment of the first anchoring member at its engagement point and the segment of the second anchoring member at its engagement point such that the implant grip constrains the implant in its insertion shape. Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first anchoring member at a first bone, its second anchoring member at a second bone, and its bridge spanning a fusion zone of the first and second bones. The implant grip moves relative to the body whereby the implant grip retracts from the segments of the first and second anchoring members. The first anchoring member inserts into the first bone and the second anchoring member inserts into the second bone utilizing the body until the bridge resides adjacent the first and second bones across the fusion zone thereof. The implant grip moves relative to the body until the implant grip releases the segments of the first and second anchoring members whereby the implant grip by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first anchoring member at a first bone, its second anchoring member at a second bone, and its bridge spanning a fusion zone of the first and second bones. The first anchoring member inserts into the first bone and the second anchoring member inserts into the second bone utilizing the body until the implant grip contacts the first and second bones. More particularly, pushing on the body results in the second end thereof via the bridge inserting the first anchoring member into the first bone and the second anchoring member into the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Moreover, the implant grip via its contact with the first and second bones moves relative to the body until the implant grip releases the segments of the first and second anchoring members whereby the implant grip by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Loading an implant insertion device according to an alternative embodiment includes positioning the body relative to the implant whereby the second end of the body abuts the bridge of the implant. The actuator and then moves relative to the body whereby the first and second blades extend beyond the bridge and respectively engage the segments of the first and second anchoring members at their engagement points such that the implant grip constrains the implant in its insertion shape.

Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first anchoring member at a first bone, its second anchoring member at a second bone, and its bridge spanning a fusion zone of the first and second bones. The actuator moves relative to the body whereby the first and second blades retract respectively from the segments of the first and second anchoring members The first anchoring member inserts into the first bone and the second anchoring member inserts into the second bone utilizing the body until the bridge resides adjacent the first and second bones across the fusion zone thereof. The actuator moves relative to the body until the first and second blades release respectively the segments of the first and second anchoring members whereby the first and second blades by-pass the bridge and release the implant such that the implant attempts to transition from its insertion shape to its natural shape.

When using a drill guide during implantation of the implant, a fixation device inserts into a first bone and a second bone across a fusion zone thereof. The template introduces into the fusion zone of the first and second bone utilizing the grip until the slot receives therein the fixation device, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the second bone adjacent a second side of the fusion zone proximate a second side of the fixation device, and the body spans the fusion zone. A first drill hole is formed in the first bone utilizing the first passage and a second drill hole is formed in the second bone using the second passage followed by a removal of the drill guide from the first and second bones. The first and second bones are compressed at their fusion zone thereby reducing a separation distance thereof. The implant insertion device positions the implant with its first anchoring member at the first drill hole of the first bone, its second anchoring member at the second drill hole of the second bone, and its bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first and second anchoring members while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone and the second anchoring member into the second drill hole of the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first and second anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape. If desired, the fixation device then is removed from the first and second bones. A distance between the first and second passages substantially equals a distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant resides in its insertion shape plus a distance equal to a thickness of the template such that removing the template from the fusion zone and compressing the first and second bones at their fusion zone reduces a separation distance of the first drill hole from the second drill hole to a separation distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant resides in its insertion shape.

When using an alternative drill guide during implantation of the implant, a fixation device inserts through a first bone and a second bone across a fusion zone thereof. The body of the drill guide is positioned on the first and second bones across the fusion zone thereof using at least one of the first and second grips whereby the first template resides adjacent the first bone and the second template resides adjacent the second bone such that the slots of the first and second templates receive therein the fixation device. With the body of the drill guide situated on the first and second bones, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, whereas the second passage resides on the second bone adjacent a second side of the fusion zone proximate a second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passage and a second drill hole is formed in the second bone using the second passage followed by a removal of the drill guide from the first and second bones. The implant insertion device positions the implant with its first anchoring member at the first drill hole of the first bone, its second anchoring member at the second drill hole of the second bone, and its bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first and second anchoring members while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone and the second anchoring member into the second drill hole of the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first and second anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape. If desired, the fixation device then is removed from the first and second bones.

In accordance with a method for an orthopedic fixation system including the implant with first, second, and third anchoring members extending from the bridge, an implant insertion device loads with the implant. The implant insertion device by-passes the bridge and engages the segments of the first and third anchoring members at their engagement points and the first and second segments of the second anchoring member at its first and second engagement points such that the implant insertion device constrains the implant in its insertion shape. The implant utilizing the implant insertion device is positioned with its first and third anchoring members at a first bone, its second anchoring members at a second bone, and its bridge spanning a fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first and third anchoring members and the first and second segments of the second anchoring member while the implant insertion device is used to insert the first and third anchoring members into the first bone and the second anchoring member into the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first and third anchoring members and the first and second segments of the second anchoring member is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Loading the implant insertion device with the implant includes moving the implant grip relative to the body whereby the implant grip by-passes the bridge and engages the segments of the first and third anchoring members at their engagement points and the first and second segments of the second anchoring member at its first and second engagement points such that the implant grip constrains the implant in its insertion shape. Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first and third anchoring members at a first bone, its second anchoring member at a second bone, and its bridge spanning a fusion zone of the first and second bones. The implant grip moves relative to the body whereby the implant grip retracts from the segments of the first and third anchoring members and the first and second segments of the second anchoring member. The first and third anchoring members insert into the first bone and the second anchoring member inserts into the second bone utilizing the body until the bridge resides adjacent the first and second bones across the fusion zone thereof. The implant grip moves relative to the body until the implant grip releases the segments of the first and third anchoring members and the first and second segments of the second anchoring member whereby the implant grip by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first and third anchoring members at a first bone, its second anchoring member at a second bone, and its bridge spanning a fusion zone of the first and second bones. The first and third anchoring members insert into the first bone and the second anchoring member into the second bone utilizing the body until the implant grip contacts the first and second bones. More particularly, pushing on the body results in the second end of the body via the bridge inserting the first and third anchoring members into the first bone and the second anchoring member into the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. The implant grip via its contact with the first and second bones moves relative to the body until the implant grip releases the segments of the first and third anchoring members and the first and second segments of the second anchoring member whereby the implant grip by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Loading an implant insertion device according to an alternative embodiment includes positioning the body relative to the implant whereby the second end of the body abuts the bridge of the implant. The actuator moves actuator relative to the body whereby the first and second blades extend beyond the bridge and respectively engage the segments of the first and third anchoring members at their engagement points and the first and second segments of the second anchoring member at its first and second engagement points such that the implant grip constrains the implant in its insertion shape.

Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first and third anchoring members at a first bone, its second anchoring member at a second bone, and its bridge spanning a fusion zone of the first and second bones. The actuator moves relative to the body whereby the first and second blades retract respectively from the segments of the first and third anchoring members and the first and second segments of the second anchoring member. The first and third anchoring members insert into the first bone and the second anchoring member inserts into the second bone utilizing the body until the bridge resides adjacent the first and second bones across the fusion zone thereof. The actuator moves relative to the body until the first and second blades release respectively the segments of the first and third anchoring members and the first and second segments of the second anchoring member whereby the first and second blades by-pass the bridge and release the implant such that the implant attempts to transition from its insertion shape to its natural shape.

When using a drill guide during implantation of the implant, a fixation device inserts into a first bone and a second bone across a fusion zone thereof. The template introduces into the fusion zone of the first and second bone utilizing the grip until the slot receives therein the fixation device, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the second bone adjacent a second side of the fusion zone proximate one of the first side of the fixation device and the second side of the fixation device, and the body spans the fusion zone. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, and a drill hole is formed in the second bone utilizing the third passage followed by a removal of the drill guide from the first and second bones. The first and second bones are compressed at their fusion zone thereby reducing a separation distance thereof. The implant insertion device positions the implant with its first anchoring member at the first drill hole of the first bone, its second anchoring member at the second drill hole of the first bone, and its third anchoring member at the drill hole of the second bone, and its bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first, second, and third anchoring members while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone, the second anchoring member into the second drill hole of the first bone, and the third anchoring member into the drill hole of the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first, second, and third anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape. If desired, the fixation device then is removed from the first and second bones. A distance between the first and second passages and the third passage substantially equals a distance between the first and second anchoring members of the implant and the third anchoring member of the implant when the implant resides in its insertion shape plus a distance equal to a thickness of the template such that removing the template from the fusion zone and compressing the first and second bones at their fusion zone reduces a separation distance of the first and second drill holes of the first bone from the drill hole in the second bone to a separation distance between the first and second anchoring members of the implant and the third anchoring members of the implant when the implant resides in its insertion shape.

When using an alternative drill guide during implantation of the implant, a fixation device inserts through a first bone and a second bone across a fusion zone thereof. The body of the drill guide on the first and second bones is positioned across the fusion zone thereof using at least one of the first and second grips whereby the first template resides adjacent the first bone and the second template resides adjacent the second bone such that the slots of the first and second templates receive therein the fixation device. With the body of the drill guide situated on the first and second bones, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, and the third passage resides on the second bone adjacent a second side of the fusion zone proximate one of the first side of the fixation device and the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, and a drill hole is formed in the second bone utilizing the third passage followed by a removal of the drill guide from the first and second bones. The implant insertion device positions the implant with its first anchoring member at the first drill hole of the first bone, its second anchoring member at the second drill hole of the first bone, its third anchoring member at the drill hole of the second bone, and its bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first, second, and third anchoring members while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone, the second anchoring member into the second drill hole of the first bone, the third anchoring member into the drill hole of the second until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first, second, and third anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape. If desired, the fixation device then is removed the from the first and second bones.

In accordance with a method for an orthopedic fixation system including the implant with first, second, third, and fourth anchoring members extending from the bridge, an implant insertion device loads with the implant. The implant insertion device by-passes the bridge and engages the segments of the first, second, third, and fourth anchoring member at their engagement points such that the implant insertion device constrains the implant in its insertion shape. The implant utilizing the implant insertion device is positioned with its first and second anchoring members at a first bone, its third and fourth anchoring members at a second bone, and its bridge spanning a fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first, second, third, and fourth anchoring members while the implant insertion device is used to insert the first and second anchoring members into the first bone and the third and fourth anchoring members into the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first, second, third, and fourth anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Loading the implant insertion device with the implant includes moving the implant grip relative to the body whereby the implant grip by-passes the bridge and engages the segments of the first, second, third, and fourth anchoring members at their engagement points such that the implant grip constrains the implant in its insertion shape. Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first and second anchoring members at a first bone, its third and fourth anchoring members at a second bone, and its bridge spanning a fusion zone of the first and second bones. The implant grip moves relative to the body whereby the implant grip retracts from the segments of the first, second, third, and fourth anchoring members. The first and second anchoring members insert into the first bone and the third and fourth anchoring members insert into the second bone utilizing the body until the bridge resides adjacent the first and second bones across the fusion zone thereof. The implant grip moves relative to the body until the implant grip releases the segments of the first, second, third, and fourth anchoring members whereby the implant grip by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first and second anchoring members at a first bone, its third and fourth anchoring members at a second bone, and its bridge spanning a fusion zone of the first and second bones. The first and second anchoring members insert into the first bone and the third and fourth anchoring members insert into the second bone utilizing the body until the implant grip contacts the first and second bones. More particularly, pushing on the body results in the second end of the body via the bridge inserting the first and second anchoring members into the first bone and the third and fourth anchoring members into the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. The implant grip via its contact with the first and second bones moves relative to the body until the implant grip releases the segments of the first, second, third, and fourth anchoring members whereby the implant grip by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape.

Loading an implant insertion device according to an alternative embodiment includes positioning the body relative to the implant whereby the second end of the body abuts the bridge of the implant. The actuator moves relative to the body whereby the first and second blades extend beyond the bridge and respectively engage the segments of the first, second, third, and fourth anchoring members at their engagement points such that the implant grip constrains the implant in its insertion shape.

Positioning and implanting the implant includes utilizing the body of the implant insertion device to place the implant with its first and second anchoring members at a first bone, its third and fourth anchoring members at a second bone, and its bridge spanning a fusion zone of the first and second bones. The actuator moves relative to the body whereby the first and second blades retract respectively from the segments of the first, second, third, and fourth anchoring members. The first and second anchoring members insert into the first bone and the third and fourth anchoring members insert into the second bone utilizing the body until the bridge resides adjacent the first and second bones across the fusion zone thereof. The actuator moves relative to the body until the first and second blades release respectively the segments of the first, second, third, and fourth anchoring members whereby the first and second blades by-pass the bridge and release the implant such that the implant attempts to transition from its insertion shape to its natural shape.

When using a drill guide during implantation of the implant, a fixation device inserts into a first bone and a second bone across a fusion zone thereof. The template introduces into the fusion zone of the first and second bone utilizing the grip until the slot receives therein the fixation device, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the second bone adjacent a second side of the fusion zone proximate the first side of the fixation device, the fourth passage resides on the second bone adjacent the second side of the fusion zone proximate the second side of the fixation device, and the body spans the fusion zone. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, a first drill hole is formed in the second bone utilizing the third passage, and a second drill hole is formed in the second bone utilizing the fourth passage followed by a removal of the drill guide from the first and second bones. The first and second bones are compressed at their fusion zone thereby reducing a separation distance thereof. The implant insertion device positions the implant with its first anchoring member at the first drill hole of the first bone, its second anchoring member at the second drill hole of the first bone, its third anchoring member at the first drill hole of the second bone, its fourth anchoring member at the second drill hole of the second bone, and its bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first, second, third, and fourth anchoring members while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone, the second anchoring member into the second drill hole of the first bone, the third anchoring member into the first drill hole of the second bone, and the fourth anchoring member into the second drill hole of the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first, second, third, and fourth anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape. If desired, the fixation device then is removed from the first and second bones. A distance between the first and third passages and the second and fourth passages substantially equals a distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant resides in its insertion shape plus a distance equal to a thickness of the template such that removing the template from the fusion zone and compressing the first and second bones at their fusion zone reduces a separation distance of the first drill hole of the first bone from the first drill hole in the second bone and the second drill hole of the first bone from the second drill hole of the second bone to a separation distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant resides in its insertion shape.

When using an alternative drill guide during implantation of the implant, a fixation device inserts through a first bone and a second bone across a fusion zone thereof. The body of the drill guide is positioned on the first and second bones across the fusion zone thereof using at least one of the first and second grips whereby the first template resides adjacent the first bone and the second template resides adjacent the second bone such that the slots of the first and second templates receive therein the fixation device. With the body of the drill guide situated on the first and second bones, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the second bone adjacent a second side of the fusion zone proximate the first side of the fixation device, and the fourth passage resides on the second bone adjacent the second side of the fusion zone proximate the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, a first drill hole is formed in the second bone utilizing the third passage, and a second drill hole is formed in the second bone utilizing the fourth passage followed by a removal of the drill guide from the first and second bones. The implant insertion device positions the implant with its first anchoring member at the first drill hole of the first bone, its second anchoring member at the second drill hole of the first bone, its third anchoring member at the first drill hole of the second bone, its fourth anchoring member at the second drill hole of the second bone, and its bridge spanning the fusion zone of the first and second bones. The implant insertion device retracts from the segments of the first, second, third, and fourth anchoring members while the implant insertion device inserts the first anchoring member into the first drill hole of the first bone, the second anchoring member into the second drill hole of the first bone, the third anchoring member into the first drill hole of the second bone, and the fourth anchoring member into the second drill hole of the second bone until the bridge resides adjacent the first and second bones across the fusion zone thereof. Engagement of the implant insertion device with the segments of the first, second, third, and fourth anchoring members is removed whereby the implant insertion device by-passes the bridge and releases the implant such that the implant attempts to transition from its insertion shape to its natural shape. If desired, the fixation device then is removed from the first and second bones.

In accordance with an implantation method including a drill guide with first and second passages, a fixation device inserts into a first bone and a second bone across a fusion zone thereof. The template introduces into the fusion zone of the first and second bone utilizing the grip until the slot receives therein the fixation device. As a result, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the second bone adjacent a second side of the fusion zone proximate a second side of the fixation device, and the body spans the fusion zone. A drill hole is formed in the first bone utilizing the first passage, while a drill hole is formed in the second bone using the second passage. The drill guide removes from the first and second bones followed by a compressing of the first and second bones at their fusion zone thereby reducing a separation distance thereof. A first anchoring member of an implant inserts into the drill hole of the first bone and a second anchoring member of the implant inserts into the drill hole of the second bone until a bridge of the implant resides adjacent the first and second bones across the fusion zone thereof, whereby the implant attempts to transition from an insertion shape to a natural shape. If desired, the fixation device then is removed from the first and second bones. A distance between the first and second passages substantially equals a distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant resides in its insertion shape plus a distance equal to a thickness of the template such that removing the template from the fusion zone and compressing the first and second bones at their fusion zone reduces a separation distance of the drill hole of the first bone from the drill hole of the second bone to a separation distance between the first anchoring member of the implant and the second anchoring member of the implant when the implant resides in its insertion shape.

In accordance with an implantation method including an alternative drill guide with first and second passages, a fixation device inserts through a first bone and a second bone across a fusion zone thereof. The body of the drill guide is positioned on the first and second bones across the fusion zone thereof using at least one of the first and second grips whereby the first template resides adjacent the first bone and the second template resides adjacent the second bone such that the slots of the first and second templates receive therein the fixation device. With the body of the drill guide situated on the first and second bones, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, whereas and the second passage resides on the second bone adjacent a second side of the fusion zone proximate a second side of the fixation device. A drill hole is formed in the first bone utilizing the first passage while a drill hole is formed in the second bone using the second passage followed by a removal of the drill guide from the first and second bones. A first anchoring member of an implant inserts into the drill hole of the first bone and a second anchoring member of the implant inserts into the drill hole of the second bone until a bridge of the implant resides adjacent the first and second bones across the fusion zone thereof, whereby the implant attempts to transition from an insertion shape to a natural shape. If desired, the fixation device then is removed from the first and second bones.

In accordance with an implantation method including a drill guide with first, second, and third passages, a fixation device inserts into a first bone and a second bone across a fusion zone thereof. The template introduces into the fusion zone of the first and second bone utilizing the grip until the slot receives therein the fixation device. As a result, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the second bone adjacent a second side of the fusion zone proximate one of the first side of the fixation device and the second side of the fixation device, and the body spans the fusion zone. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, and a drill hole is formed in the second bone utilizing the third passage. The drill guide is removed from the first and second bones followed by a compressing of the first and second bones at their fusion zone thereby reducing a separation distance thereof. A first anchoring member of an implant inserts into the first drill hole of the first bone, a second anchoring member of the implant inserts into the second drill hole of the first bone, and a third anchoring member of the implant inserts into the drill hole of the second bone until a bridge of the implant resides adjacent the first and second bones across the fusion zone thereof, whereby the implant attempts to transition from an insertion shape to a natural shape. If desired, the fixation device is then removed from the first and second bones. A distance between the first and second passages and the third passage substantially equals a distance between the first and second anchoring members of the implant and the third anchoring member of the implant when the implant resides in its insertion shape plus a distance equal to a thickness of the template such that removing of the template from the fusion zone and compressing the first and second bones at their fusion zone reduces a separation distance of the first and second drill holes of the first bone from the drill hole in the second bone to a separation distance between the first and second anchoring members of the implant and the third anchoring members of the implant when the implant resides in its insertion shape.

In accordance with an implantation method including an alternative drill guide with first, second, and third passages, a fixation device inserts through a first bone and a second bone across a fusion zone thereof. The body of the drill guide is positioned on the first and second bones across the fusion zone thereof using at least one of the first and second grips whereby the first template resides adjacent the first bone and the second template resides adjacent the second bone such that the slots of the first and second templates receive therein the fixation device. With the body of the drill guide situated on the first and second bones, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, and the third passage resides on the second bone adjacent a second side of the fusion zone proximate one of the first side of the fixation device and the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, and a drill hole is formed in the second bone utilizing the third passage followed by a removal of the drill guide from the first and second bones. A first anchoring member of an implant inserts into the first drill hole of the first bone, a second anchoring member of the implant inserts into the second drill hole of the first bone, and a third anchoring member of the implant inserts into the drill hole of the second bone until a bridge of the implant resides adjacent the first and second bones across the fusion zone thereof, whereby the implant attempts to transition from an insertion shape to a natural shape. If desired, the fixation device then is removed from the first and second bones.

In accordance with an implantation method including a drill guide with first, second, third, and fourth passages, a fixation device inserts into a first bone and a second bone across a fusion zone thereof. The template introduces into the fusion zone of the first and second bone utilizing the grip until the slot receives therein the fixation device. As a result, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the second bone adjacent a second side of the fusion zone proximate a first side of the fixation device, the fourth passage resides on the second bone adjacent the second side of the fusion zone proximate a second side of the fixation device, and the body spans the fusion zone. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, a first drill hole is formed in the second bone utilizing the third passage, and a second drill hole is formed in the second bone utilizing the fourth passage. The drill guide is removed from the first and second bones followed by a compressing of the first and second bones at their fusion zone thereby reducing a separation distance thereof. A first anchoring member of an implant inserts into the first drill hole of the first bone, a second anchoring member of the implant inserts into the second drill hole of the first bone, a third anchoring member of the implant inserts into the first drill hole of the second bone, and a fourth anchoring member of the implant inserts into the second drill hole of the second bone until a bridge of the implant resides adjacent the first and second bones across the fusion zone thereof, whereby the implant attempts to transition from an insertion shape to a natural shape. If desired, the fixation device is then removed from the first and second bones. A distance between the first and third passages and the second and fourth passages substantially equals a distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant resides in its insertion shape plus a distance equal to a thickness of the template such that removing the template from the fusion zone and compressing the first and second bones at their fusion zone reduces a separation distance of the first drill hole of the first bone from the first drill hole in the second bone and the second drill hole of the first bone from the second drill hole of the second bone to a separation distance between the first and third anchoring members of the implant and the second and fourth anchoring members of the implant when the implant resides in its insertion shape.

In accordance with an implantation method including an alternative drill guide with first, second, third, and fourth passages, a fixation device inserts through a first bone and a second bone across a fusion zone thereof. The body of the drill guide on the first and second bones is positioned across the fusion zone thereof using at least one of the first and second grips whereby the first template resides adjacent the first bone and the second template resides adjacent the second bone such that the slots of the first and second templates receive therein the fixation device. With the body of the drill guide situated on the first and second bones, the first passage resides on the first bone adjacent a first side of the fusion zone proximate a first side of the fixation device, the second passage resides on the first bone adjacent the first side of the fusion zone proximate a second side of the fixation device, the third passage resides on the second bone adjacent a second side of the fusion zone proximate the first side of the fixation device, and the fourth passage resides on the second bone adjacent the second side of the fusion zone proximate the second side of the fixation device. A first drill hole is formed in the first bone utilizing the first passage, a second drill hole is formed in the first bone using the second passage, a first drill hole is formed in the second bone utilizing the third passage, and a second drill hole is formed in the second bone utilizing the fourth passage followed by a removal of the drill guide from the first and second bones. A first anchoring member of an implant inserts into the first drill hole of the first bone, a second anchoring member of the implant inserts into the second drill hole of the first bone, a third anchoring member of the implant inserts into the first drill hole of the second bone, and a fourth anchoring member of the implant inserts into the second drill hole of the second bone until a bridge of the implant resides adjacent the first and second bones across the fusion zone thereof, whereby the implant attempts to transition from an insertion shape to a natural shape. If desired, the fixation device then is removed from the first and second bones.

It is therefore an object of the present invention to provide an implant with a bridge and anchoring members including a segment exterior of the bridge whereby the implant transitions between a natural shape and an insertion shape.

It is another object of the present invention to provide an implant insertion device that engages the implant at the segments of its anchoring members in order to constrain the implant in its insertion shape.

It is a further object of the present invention to provide the implant insertion device whereby the implant insertion device delivers the implant at a surface of bone, bones, or bone pieces such that tamping of the implant is eliminated.

It is still a further object of the present invention to provide a drill guide that facilitates introduction of an implant into bone, bones, or bone pieces proximate to a fixation device holding the bone, bones, or bone pieces in a desired alignment.

Still other objects, features, and advantages of the present invention will become evident to those of ordinary skill in the art in light of the following. Also, it should be understood that the scope of this invention is intended to be broad, and any combination of any subset of the features, elements, or steps described herein is part of the intended scope of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Figures are not necessarily to scale, and some features may be exaggerated to show details of particular components or steps.

FIGS.1A-1Eillustrate an orthopedic implant5according to a first embodiment in a natural shape6, whereasFIGS.2A-2Eillustrate the orthopedic implant5in an insertion shape7. The implant5in the first embodiment may be manufactured from a shape memory material with superelastic or temperature dependent properties (e.g., Nitinol) such that the implant5transitions between its natural shape6and its insertion shape7. The implant5when deformed from its natural shape6to its insertion shape7stores energy deliverable to bone, bones, or bone pieces. In accordance with its manufacture from shape memory material, the implant5begins in its natural shape6, is transitionable to its insertion shape7, and, once implanted in bone, bones, or bone pieces, attempts to transition from its insertion shape7to its natural shape6whereby the implant5delivers the energy stored therein to the bone, bones, or bone pieces in order to affix the bone, bones, or bone pieces and promote a healing thereof. In the first embodiment, attempted transition of the implant5from its insertion shape7to its natural shape6continuously compresses the bone, bones, or bone pieces to promote fusion thereof.

The implant5includes a bridge8with upper and lower surfaces9and10, first and second sides11and12, and first and second ends13and14defining a perimeter in alignment with a longitudinal axis of the bridge. The first and second sides11and12and the first and second ends13and14in the first embodiment of the implant5include a respective concave section11a,12a,13a, and14aalong at least a portion thereof. The implant5further includes transition sections15and16at the first end13of the bridge8and transition sections17and18at the second end14of the bridge8. More particularly, in the first embodiment, the transition section15resides at a corner19of the bridge8at its first end13, whereas the transition section16resides at a corner20of the bridge8at its first end13. Similarly, the transition section17resides at a corner21of the bridge8at its first end14, whereas the transition section18resides at a corner22of the bridge8at its first end14.

The implant5in the first embodiment includes an anchoring member in the form of a leg23extending from the lower surface10of the bridge8at the corner19interior to the first end13of the bridge8and, in particular, the transition section15at the corner19; an anchoring member in the form of a leg24extending from the lower surface10of the bridge8at the corner20interior to the first end13of the bridge8and, in particular, the transition section16at the corner20; an anchoring member in the form of a leg25extending from the lower surface10of the bridge8at the corner21interior to the second end14of the bridge8and, in particular, the transition section17at the corner21; and an anchoring member in the form of a leg26extending from the lower surface10of the bridge8at the corner22interior to the second end14of the bridge8and, in particular, the transition section18at the corner22. In the first embodiment, the legs23-26are formed integrally with the bridge8at a respective corner19-22and, in particular, at a respective transition section15-18. Each leg23-26, which has a respective tip27-30, may include barbs thereon that improve the pull-out resistance of the implant5. The implant5includes anchoring members in the form of the legs23-26in order to facilitate a securing of the implant5with bone, bones, or bone pieces whereby the bridge8between the legs23-26traverses a fixation zone of the bone, bones, or bone pieces such that the implant5, after its insertion and attempted transition from the insertion shape7to the natural shape6, delivers energy to the bone, bones, or bone pieces at the fixation zone.

The leg23in the first embodiment includes a width31between sides32and33such that a segment34of the leg23extends interior to the perimeter of the bridge8at the first end13and exterior to the perimeter of the bridge8at its first side11in order to provide an engagement point35whereby an implant engagement device by-passes the bridge8at its first side11and abuts the engagement point35. The leg24in the first embodiment includes a width36between sides37and38such that a segment39of the leg24extends interior to the perimeter of the bridge8at the first end13and exterior to the perimeter of the bridge8at its second side12in order to provide an engagement point40whereby an implant engagement device by-passes the bridge8at its second side12and abuts the engagement point40. The leg25in the first embodiment includes a width41between sides42and43such that a segment44of the leg25extends interior to the perimeter of the bridge8at the second end14and exterior to the perimeter of the bridge8at its first side11in order to provide an engagement point45whereby an implant engagement device by-passes the bridge8at its first side11and abuts the engagement point45. The leg26in the first embodiment includes a width46between sides47and48such that a segment49of the leg26extends interior to the perimeter of the bridge8at the second end14and exterior to the perimeter of the bridge8at its second side12in order to provide an engagement point50whereby an implant engagement device by-passes the bridge8at its second side12and abuts the engagement point50.

The regular inherent shape of the implant5, as illustrated inFIGS.1A-1E, is its natural shape6where the transition sections15-18locate the bridge8in a natural form that places the legs23-26in a natural position whereby the legs23-26are convergent and spaced apart at a first distance. Nevertheless, as illustrated inFIGS.2A-2E, the implant5is deformable under the action of superelasticity or temperature dependent shape memory to an insertion shape7where the transition sections15-18deform to store energy while also moving the bridge8from its natural form to an insertion form that places the legs23-26in an insertion position whereby the legs23-26are substantially parallel and spaced apart at a second distance that is greater than the first distance. Since the insertion shape7is not the regular inherent shape of the implant5, the bridge8typically is mechanically constrained using an implant insertion device whereby the implant insertion device maintains the bridge8in its insertion form. In order to facilitate engagement of an implant insertion device with the implant5, the legs23-26, respectively, include the engagement points35,40,45, and50that receive the implant insertion device. The implant insertion device by-passes the bridge8at its first and second sides11and12and abuts the engagement points35,40,45, and50. In particular, the implant insertion device extends beyond the bridge8at its first and second sides11and12and abuts the engagement points35,40,45, and50such that the implant insertion device engages and then holds the legs23-26, resulting in the implant insertion device constraining the deformed transition sections15-18in order to maintain the implant5in its insertion shape7. After implantation into bone, bones, or bone pieces and a release of the implant insertion device, including if necessary a heating of the implant5, the implant5delivers the energy stored in the transition sections15-18whereby the bridge8attempts to transition from its insertion form to its natural form, which causes an attempt of the legs23-26to move from their insertion position to their natural position such that the implant5affixes the bone, bones, or bone pieces through an application of a compressive force thereto.

Although the bridge8of the implant5according to the first embodiment includes the transition sections15-18, the bridge8, alternatively, may include a transition section51located at a center section52of the implant5and thus the bridge8. The regular inherent shape of the implant5, as illustrated inFIGS.1A-1E, is its natural shape6where the transition section51locates the bridge8in a natural form consisting of a closed or angular profile whereby the first and second ends13and14reside at a first distance and the legs23-26reside in a natural position whereby the legs23-26are convergent and spaced apart at a first distance. Nevertheless, as illustrated inFIG.2F, the implant5is deformable under the action of superelasticity or temperature dependent shape memory to an insertion shape53where the transition section51deforms to store energy while also moving the bridge8from its natural form to an insertion form which is an open or substantially linear profile whereby the first and second ends13and14reside at a second distance that is greater than the first distance and the legs23-26reside in an insertion position whereby the legs23-26are substantially parallel and spaced apart at a second distance that is greater than the first distance. Since the insertion shape53is not the regular inherent shape of the implant5, the bridge8typically is mechanically constrained using an implant insertion device whereby the implant insertion device maintains the bridge8in its insertion form. In order to facilitate engagement of an implant insertion device with the implant5, the legs23-26, respectively, include the engagement points35,40,45, and50that receive the implant insertion device. The implant insertion device by-passes the bridge8at its first and second sides11and12and abuts the engagement points35,40,45, and50. In particular, the implant insertion device extends beyond the bridge8at its first and second sides11and12and abuts the engagement points35,40,45, and50such that the implant insertion device engages and then holds the legs23-26, resulting in the implant insertion device constraining the deformed transition section51in order to maintain the implant5in its insertion shape7. After implantation into bone, bones, or bone pieces and a release of the implant insertion device, including if necessary a heating of the implant5, the implant5delivers the energy stored in the transition section51whereby the bridge8attempts to transition from its insertion form to its natural form, which causes an attempt of the legs23-26to move from their insertion position to their natural position such that the implant5affixes the bone, bones, or bone pieces through an application of a compressive force thereto.

While the first embodiment of the implant5includes either the transition sections15-18or the transition section51to produce deformation thereof, one of ordinary skill in the art will recognize that the bridge8of the implant5may include both the transition sections15-18and the transition section51to produce deformation thereof. Moreover, while the bridge8in the first embodiment includes an angular profile in the natural shape of the implant5, it should be understood by one of ordinary skill in the art that a bridge8incorporating the transition sections15-18may include a substantially linear profile for the natural shape of the implant5.

FIGS.3A-5Dillustrate an implant insertion device60that engages an implant5and retains the implant5in its insertion shape7or53.FIGS.4A-4Billustrate the implant insertion device60in an unloaded position61prior to its loading with the implant5or after its delivery of the implant5whereby the implant5releases from the implant insertion device60without obstruction.FIGS.5A-5Dillustrate the implant insertion device60in a loaded position62whereby the implant insertion device60may be loaded with the implant5such that the implant insertion device60constrains the implant5in its insertion shape7or53. The implant insertion device60allows a surgeon to manipulate the implant5and insert the implant5into bone, bones, or bone pieces requiring fixation.FIGS.6A-6Dillustrate a body63of the implant insertion device60, whereasFIGS.7A-9Billustrate an implant grip64of the implant insertion device60that is coupled with the body63and is movable relative to the body63between a disengaged position65shown inFIGS.4A-4Band an engaged position66shown inFIGS.5A-SD.

The implant grip64as illustrated inFIGS.7A-9Bincludes a shell67with a passage70therethrough that permits the implant grip64to interface with the implant5and the body63. The shell67includes an exterior surface68with an upper surface89and a lower surface90and an interior surface69that defines the passage70therethrough whereby the passage70at the lower surface90receives therein the implant5and the passage70at the upper surface89receives therein the body63. The interior surface69of the shell67and thus the passage70include a shape complimentary with the implant5and, in particular, with the first and second sides11and12and the first and second ends13and14of the implant5whereby the shell67grips the implant5and retains the implant5therein. More particularly, the implant5inserts into the shell67via the passage70beginning at the lower surface90and is held therein due to a frictional engagement of the interior surface69with the implant5such that the shell67encloses the implant5and constrains the implant5in its insertion shape7or53. The interior surface69of the shell67and thus the passage70due to their shape complimentary with the implant5define a groove71-74located at a respective corner75-78of the interior surface69that respectively receives therein a segment34,39,44, and49of the legs23-26whereby the interior surface69at the grooves71-74respectively frictionally engages the legs23-26of the implant5thereby retaining the implant5within the shell67. The interior surface69in each groove71-74further defines a retention surface79-82that respectively abuts an engagement point35,40,44, and50of the legs23-26in order to grip and then constrain the legs23-26such that the shell67retains the implant5in its insertion shape7or53. While the frictional engagement between the interior surface69and the implant5and, in particular, between the interior surface69at its grooves71-74and retention surfaces79-82with the legs23-26and their segments34,39,44, and49retains the implant5within the shell67, the shell67at its interior surface69, in order to provide additional retention of the implant5within the shell67, includes projections83-86that grip a respective leg23-26opposite to the segments34,39,44, and49. Upon the insertion of the implant5into the passage70, the projections83-86by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereof and then frictionally engage a respective leg23-26opposite to the segments34,39,44, and49, thereby assisting in retaining the implant5within the shell67. Alternatively, the projections83-86may be resilient whereby, during the insertion of the implant5into the passage70, the projections83-86move relative to bridge8at its first and second ends13and14and then return to frictionally engage a respective leg23-26opposite to the segments34,39,44, and49, thereby assisting in retaining the implant5within the shell67including operating as a stop relative to the bridge8that prevents accidental release of the implant5from the implant grip64. The shell67at its interior surface69includes detents87and88that engage the body63to assist in coupling the shell67with the body63and further to limit the motion of the shell67relative to the body63as the implant grip64moves between its disengaged position65and its engaged position66.

The body63as illustrated inFIGS.6A-6Dincludes a first end75defining a handle76and a second end77defining an implant grip receiver78and a stop84adjacent the implant grip receiver78that limits the movement of the implant grip64relative to the implant grip receiver78. The handle76facilitates grasping of the implant insertion device60during its use in implanting the implant5into bone, bones, or bone pieces requiring fixation. The implant grip receiver78includes first and second sides80and81, first and second ends82and83, and a tamp79configured to engage the bridge8when the implant5resides in its insertion shape7or its insertion shape53. The implant grip receiver78and thus the first and second sides80and81and the first and second ends82and83thereof include a shape complimentary with the implant grip64and, in particular, with the interior surface69of the shell67whereby the implant grip receiver78retains the implant grip64thereon. More particularly, the implant grip receiver78inserts into the shell67via the passage70beginning at the upper surface89such that the implant grip receiver78holds the shell67thereon due to a frictional engagement between the first and second sides80and81and the first and second ends82and83of the implant grip receiver78with the interior surface69of the shell67. While the frictional engagement between the first and second sides80and81and the first and second ends82and83of the implant grip receiver78and the interior surface69of the implant grip64retains the shell67on the implant grip receiver78, the implant grip receiver78defines on both its first and second sides80and81notches91and92that aid in retaining the shell67on the implant grip receiver78and further locate the implant grip64in either its disengaged position65or its engaged position66. In particular, the detents87and88on the interior surface69of the shell67, during insertion of the implant grip receiver78into the shell67, move respectively into the notches92thereby locking the implant grip64in its engaged position66relative to the implant grip receiver78or into the notches91thereby locking the implant grip64in its disengaged position65relative to the implant grip receiver78. The first and second ends82and83define respectively indentations93and94that prevent the implant grip receiver78from contacting the projections83-86when the implant grip64resides in its disengaged position65. In the first embodiment of the implant insertion device60, the length of the implant grip receiver78for the body63substantially equals the length of the implant grip64. With the implant insertion device60in its unloaded position61, the implant grip receiver78inserts substantially, completely within the implant grip64until the implant grip64reaches its disengaged position65whereby the tamp79of the implant grip receiver78resides at the lower surface90of the implant grip64such that the tamp79facilitates delivery of the implant5from the implant grip64into bone, bones, or bone pieces. With the implant insertion device60in its loaded position62, the implant grip receiver78moves within the implant grip64relative thereto until the implant grip64reaches its engaged position66whereby the implant5inserts into the implant grip64such that the tamp79of the implant grip receiver78resides adjacent the bridge8of the implant5.

Loading the implant insertion device60with the implant5includes the implant grip receiver78receiving thereon the implant grip64. As illustrated inFIGS.3A and3B, the implant grip receiver78inserts into the implant grip64beginning with its tamp79being located at the upper surface89of the shell67. After insertion into the implant grip64, the implant grip receiver78moves within the shell67via the passage70whereby a frictional engagement of the first and second sides80and81and the first and second ends82and83for the implant grip receiver78retains the implant grip64on the implant grip receiver78. The implant grip receiver78moves within the shell67via the passage70until the detents88and89respectively slide into the notches92thereby locking the implant grip64in its engaged position66relative to the implant grip receiver78. The detents88and89and the notches92cooperate to prevent removal of the implant grip64from the implant grip receiver78without application of a removal force imparted to the implant grip64and the implant grip receiver78. After insertion of the implant grip receiver78into the implant grip64, the implant grip receiver78further inserts into the implant grip64via the passage70of the shell67until the upper surface89of the shell67abuts the stop84of the body63whereby the detents88and89disengage from the notches92and respectively slide into the notches91thereby locking the implant grip64in its disengaged position65relative to the implant grip receiver78.

When receiving the implant5in an orthopedic fixation system, the implant insertion device60as illustrated inFIGS.4A and4Bbegins in its unloaded position61wherein the implant grip64resides in its disengaged position65. The implant5is mechanically deformed from its natural shape6to its insertion shape7as illustrated inFIGS.2A-2Eor its insertion shape53as illustrated inFIG.2Fsuch that the implant5stores mechanical energy. Mechanical deformation of the implant5may include cooling of the implant5such that the implant5transitions from its austenite phase to its martensite phase prior to loading of the implant5on the implant insertion device60. After deformation of the implant5, the deformed implant5is positioned adjacent the implant insertion device60whereby the implant5resides at the passage70of the shell67interior of the lower surface90for the implant grip64such that the tamp79of the implant grip receiver78for the body63resides atop the bridge8of the implant5.

Once the shell67of the implant grip64aligns with the bridge8such that the implant5resides at the passage70of the implant grip64, a force applied to the implant grip64transitions the implant insertion device60from its unloaded position61to its loaded position62as illustrated inFIGS.5A-5D,8A-8B, and9A-9Bwhereby the implant insertion device60retains the implant5in its insertion shape7or53. In particular, the force applied to the implant grip64moves the implant grip64relative to the implant grip receiver78of the body63from its disengaged position65to its engaged position66, resulting in the detents88and89disengaging from the notches91and respectively sliding into the notches92thereby locking the implant grip64in its engaged position66relative to the implant grip receiver78. The movement of the implant grip64relative to the body63from its disengaged position65to its engaged position66inserts the implant5into the passage70of the shell67thereby seating the implant5within the implant grip64with the shell67disposed thereabout. The passage70receives the implant5such that the shell67retains the implant5therein due to the interior surface69of the shell67and thus the passage70including a shape complimentary with the implant5whereby the interior surface69is sized to permit introduction of the implant5while also frictionally engaging the implant5as illustrated inFIG.8B. The bridge8of the implant5at its first and second sides11and12and its first and second ends13and14inserts into the passage70of the shell67whereas the interior surface69of the shell67frictionally engages the first and second sides11and12of the bridge8at their concave sections11aand12ain order to retain the bridge8in the implant grip64. When the implant5inserts into the implant grip64during transition of the implant grip64from its disengaged position65to its engaged position66, the shell67at its interior surface69receives the bridge8therein and progresses beyond the bridge8such that a groove71-74of the interior surface69for the shell67respectively receives therein a segment34,39,44, and49of the legs23-26whereby the interior surface69at the grooves71-74respectively frictionally engages the legs23-26of the implant5thereby retaining the implant5within the shell67in its insertion shape7or53. Moreover, a retention surface79-82disposed in each of the grooves71-74respectively abuts an engagement point35,40,44, and50of the legs23-26in order to grip and then constrain the legs23-26wherein the shell67retains the implant5in its insertion shape7or53. In addition, during the insertion of the implant5into the passage70of the shell67, the projections83-86of the interior surface69by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereof and then frictionally engage a respective leg23-26opposite from the segments34,39,44, and49, thereby assisting in retaining the implant5within the shell67in its insertion shape7or53. The projections83-86, when they resiliently by-pass the bridge8, further prevent release of the implant5from the implant grip64without application of an extrusion force exerted against the implant5using the tamp79of the implant grip receiver78and the body63. After the implant grip64reaches its engaged position66with the detents88and89retained in the notches92, the tamp79of the implant grip receiver78for the body63remains atop the bridge8of the implant5while concurrently the grooves71-74and the projections83-86maintain the implant5within the implant grip64and the retention surfaces79-82in each of the grooves71-74defined by the shell67constrain the legs23-26such that the shell67holds the implant5in its insertion shape7or53.

When receiving the implant5in an orthopedic fixation system, the implant insertion device60alternatively may begin in its loaded position62wherein the implant grip64resides in its engaged position66with the detents88and89retained in the notches92. Upon mechanical deformation of the implant5from its natural shape6to its insertion shape7or53, the deformed implant5is positioned adjacent the implant insertion device60whereby the implant5resides at the passage70of the shell67interior of the lower surface90for the implant grip64. After the shell67of the implant grip64aligns with the bridge8such that the implant5resides at the passage70of the implant grip64, the implant grip64is held while a force applied to the body63fits the shell67over the implant5until the tamp79of the implant grip receiver78for the body63abuts the bridge8of the implant5and the implant insertion device60retains the implant5in its insertion shape7or53. In particular, the force applied to the body63with the implant grip64held in place inserts the implant5into the passage70of the shell67thereby seating the implant5within the implant grip64with the shell67disposed thereabout. The passage70receives the implant5such that the shell67retains the implant5therein due to the interior surface69of the shell67and thus the passage70including a shape complimentary with the implant5whereby the interior surface69is sized to permit introduction of the implant5while also frictionally engaging the implant5as illustrated inFIG.8B. The bridge8of the implant5at its first and second sides11and12and its first and second ends13and14inserts into the passage70of the shell67whereas the interior surface69of the shell67frictionally engages the first and second sides11and12of the bridge8at their concave sections11aand12ain order to retain the bridge8in the implant grip64. During insertion of the implant5into the implant grip64, the shell67at its interior surface69receives the bridge8therein and progresses beyond the bridge8such that a groove71-74of the interior surface69for the shell67respectively receives therein a segment34,39,44, and49of the legs23-26whereby the interior surface69at the grooves71-74respectively frictionally engages the legs23-26of the implant5thereby retaining the implant5within the shell67in its insertion shape7or53. Moreover, a retention surface79-82disposed in each of the grooves71-74respectively abuts an engagement point35,40,44, and50of the legs23-26in order to grip and then constrain the legs23-26wherein the shell67retains the implant5in its insertion shape7or53. In addition, during the insertion of the implant5into the passage70of the shell67, the projections83-86of the interior surface69by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereof and then frictionally engage a respective leg23-26opposite from the segments34,39,44, and49, thereby assisting in retaining the implant5within the shell67in its insertion shape7or53. The projections83-86, when they resiliently by-pass the bridge8, further prevent release of the implant5from the implant grip64without application of an extrusion force exerted against the implant5using the tamp79of the implant grip receiver78and the body63. After the tamp79of the implant grip receiver78for the body63reaches and sits atop the bridge8of the implant5, the grooves71-74and the projections83-86maintain the implant5within the implant grip64and the retention surfaces79-82in each of the grooves71-74defined by the shell67constrain the legs23-26such that the shell67holds the implant5in its insertion shape7or53.

While the implant5may be mechanically deformed from its natural shape6to its insertion shape7or53prior to its loading on the implant insertion device60in an orthopedic fixation system, the implant insertion device60may be employed during its loading with the implant5to mechanically deform the implant5from its natural shape6to its insertion shape7or53. The implant5in its natural shape6is positioned adjacent the implant insertion device60whereby the implant5resides at the passage70of the shell67interior of the lower surface90for the implant grip64such that the tamp79of the implant grip receiver78for the body63resides atop the bridge8of the implant5. Once the shell67of the implant grip64aligns with the bridge8such that the implant5resides at the passage70of the implant grip64, a force applied to the implant grip64transitions the implant insertion device60from its unloaded position61to its loaded position62as illustrated inFIGS.5A-5D,8A-8B, and9A-9Bwhereby the implant insertion device60moves the implant5from its natural shape6to its insertion shape7or53and then retains the implant5in its insertion shape7or53. In particular, the force applied to the implant grip64moves the implant grip64relative to the body63from its disengaged position65to its engaged position66, resulting in the detents88and89disengaging from the notches91and respectively sliding into the notches92thereby locking the implant grip64in its engaged position66relative to the implant grip receiver78. The movement of the implant grip64relative to the body63from its disengaged position65to its engaged position66inserts the implant5into the passage70of the shell67thereby seating the implant5within the implant grip64with the shell67disposed thereabout. The passage70receives the implant5such that the shell67retains the implant5therein due to the interior surface69of the shell67and thus the passage70including a shape complimentary with the implant5whereby the interior surface69is sized to permit introduction of the implant5while also frictionally engaging the implant5as illustrated inFIG.8B. The bridge8of the implant5at its first and second sides11and12and its first and second ends13and14inserts into the passage70of the shell67whereas the interior surface69of the shell67frictionally engages the first and second sides11and12of the bridge8at their concave sections11aand12ain order to retain the bridge8in the implant grip64. When the implant5inserts into the implant grip64during transition of the implant grip64from its disengaged position65to its engaged position66, the shell67at its interior surface69receives the bridge8therein and progresses beyond the bridge8such that a groove71-74of the interior surface69for the shell67respectively receives therein a segment34,39,44, and49of the legs23-26whereby the interior surface69at the grooves71-74respectively frictionally engages the legs23-26of the implant5. Moreover, a retention surface79-82disposed in each of the grooves71-74respectively abuts an engagement point35,40,44, and50of the legs23-26in order to grip the legs23-26at the engagement points35,40,44, and50and further to impart a force into the implant5that facilitates transition of the implant5from its natural shape6to its insertions shape7or53as the implant grip64travels to its engaged position66. The abutment of the retention surfaces79-82of the grooves71-74respectively with the engagement points35,40,44, and50of the legs23-26additionally constrains the legs23-26wherein the shell67retains the implant5in its insertion shape7or53. Furthermore, during the insertion of the implant5into the passage70of the shell67, the projections83-86of the interior surface69by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereof and then frictionally engage a respective leg23-26opposite from the segments34,39,44, and49, thereby assisting in retaining the implant5within the shell67in its insertion shape7or53. The projections83-86, when they resiliently by-pass the bridge8, further prevent release of the implant5from the implant grip64without application of an extrusion force exerted against the implant5using the tamp79of the implant grip receiver78and the body63. After the implant grip64reaches its engaged position66with the detents88and89retained in the notches92, the tamp79of the implant grip receiver78for the body63remains atop the bridge8of the implant5while concurrently the grooves71-74and the projections83-86maintain the implant5within the implant grip64and the retention surfaces79-82in each of the grooves71-74defined by the shell67constrain the legs23-26such that the shell67holds the implant5in its insertion shape7or53.

When receiving the implant5in an orthopedic fixation system, the implant insertion device60alternatively may begin in its loaded position62wherein the implant grip64resides in its engaged position66with the detents88and89retained in the notches92. The implant5in its natural shape6is positioned adjacent the implant insertion device60whereby the implant5resides at the passage70of the shell67interior of the lower surface90for the implant grip64. After the shell67of the implant grip64aligns with the bridge8such that the implant5resides at the passage70of the implant grip64, the implant grip64is held while a force applied to the body63fits the shell67over the implant5until the tamp79of the implant grip receiver78for the body63abuts the bridge8of the implant5and the implant insertion device60moves the implant5from its natural shape6to its insertion shape7or53and then retains the implant5in its insertion shape7or53. In particular, the force applied to the body63with the implant grip64held in place inserts the implant5into the passage70of the shell67thereby seating the implant5within the implant grip64with the shell67disposed thereabout. The passage70receives the implant5such that the shell67retains the implant5therein due to the interior surface69of the shell67and thus the passage70including a shape complimentary with the implant5whereby the interior surface69is sized to permit introduction of the implant5while also frictionally engaging the implant5as illustrated inFIG.8B. The bridge8of the implant5at its first and second sides11and12and its first and second ends13and14inserts into the passage70of the shell67whereas the interior surface69of the shell67frictionally engages the first and second sides11and12of the bridge8at their concave sections11aand12ain order to retain the bridge8in the implant grip64. During insertion of the implant5into the implant grip64, the shell67at its interior surface69receives the bridge8therein and progresses beyond the bridge8such that a groove71-74of the interior surface69for the shell67respectively receives therein a segment34,39,44, and49of the legs23-26whereby the interior surface69at the grooves71-74respectively frictionally engages the legs23-26of the implant5. Moreover, a retention surface79-82disposed in each of the grooves71-74respectively abuts an engagement point35,40,44, and50of the legs23-26in order to grip the legs23-26at the engagement points35,40,44, and50and further to impart a force into the implant5that facilitates transition of the implant5from its natural shape6to its insertions shape7or53as the implant grip64receives the implant5therein until the tamp79of the implant grip receiver78for the body63abuts the bridge8of the implant5. The abutment of the retention surfaces79-82of the grooves71-74respectively with the engagement points35,40,44, and50of the legs23-26additionally constrains the legs23-26wherein the shell67retains the implant5in its insertion shape7or53. Furthermore, during the insertion of the implant5into the passage70of the shell67, the projections83-86of the interior surface69by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereof and then frictionally engage a respective leg23-26opposite from the segments34,39,44, and49, thereby assisting in retaining the implant5within the shell67in its insertion shape7or53. The projections83-86, when they resiliently by-pass the bridge8, further prevent release of the implant5from the implant grip64without application of an extrusion force exerted against the implant5using the tamp79of the implant grip receiver78and the body63. After the tamp79of the implant grip receiver78for the body63reaches and sits atop the bridge8of the implant5, the grooves71-74and the projections83-86maintain the implant5within the implant grip64and the retention surfaces79-82in each of the grooves71-74defined by the shell67constrain the legs23-26such that the shell67holds the implant5in its insertion shape7or53.

When delivering the implant5to bone, bones, or bone pieces, the implant insertion device60as illustrated inFIGS.5A-5Dbegins in its loaded position62wherein the implant grip64in its engaged position66constrains the implant5in its insertion shape7or53. In order to release the implant5from the implant insertion device60, a force applied to the implant grip64, either at the lower surface90of the shell67as described herein or directly to the implant grip64, progresses the implant grip64from its engaged position66to its disengaged position65abutting the stop84adjacent the implant grip receiver78, resulting in the detents88and89disengaging from the notches92and respectively sliding into the notches91thereby locking the implant grip64in its disengaged position65. The tamp79of the implant grip receiver78for the body63remains atop the bridge8of the implant5to prevent movement of the implant5relative to the implant grip64during progression of the implant grip64from its engaged position66to its disengaged position65. As a consequence, the projections83-86of the interior surface69, when the implant grip64moves from its engaged position66to its disengaged position65, by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereby releasing a respective leg23-26opposite from the segments34,39,44, and49. The projections83-86insert into the indentations93and94in the implant grip receiver78to prevent the projections83-86from impeding movement of the implant grip64relative to the implant grip receiver78such that the tamp79ultimately reaches a position adjacent the lower surface90of the shell67. Similarly, the retention surfaces79-82disposed in each of the grooves71-74respectively release an engagement point35,40,44, and50of the legs23-26, while the grooves71-74of the interior surface69for the shell67respectively disengage from a segment34,39,44, and49of the legs23-26. Moreover, the interior surface69of the shell67disengages from the first and second sides11and12of the bridge8at their concave sections11aand12a, whereas the interior surface69of the shell67further by-passes the bridge8of the implant5at its first and second sides11and12and its first and second ends13and14such that the implant5exits the passage70of the shell67, resulting in the discharge of the implant5from the implant grip64and a subsequent attempted transition of the implant5from its insertion shape7or53to its natural shape6whereby the implant5delivers the energy stored therein to the bone, bones, or bone pieces.

FIGS.10A-11Dillustrate an implant insertion device100according to a second embodiment that engages the implant5and retains the implant5in its insertion shape7or53.FIGS.10A-10Dillustrate the implant insertion device100in an unloaded position101prior to its loading with the implant5or after its delivery of the implant5whereby the implant5releases from the implant insertion device100without obstruction.FIGS.11A-11Dillustrate the implant insertion device100in a loaded position102whereby the implant insertion device100may be loaded with the implant5such that the implant insertion device100retains the implant5in its insertion shape7or53. The implant insertion device100allows a surgeon to manipulate the implant5and insert the implant5into bone, bones, or bone pieces requiring fixation.FIGS.12A-12Billustrate a body103of the implant insertion device100, whereasFIGS.13A-13Billustrate an implant grip104of the implant insertion device100that is coupled with the body103and is movable relative to the body103between a disengaged position105shown inFIGS.10A-10Dand an engaged position106shown inFIGS.11A-11D.

The implant grip104as illustrated inFIGS.13A-13Bincludes a first blade107and a second blade108whereby the first and second blades107and108are secured with an actuator109in an opposed relationship defining a passage110therebetween. The first blade107and the second blade108in the second embodiment each include a first face111, a second face112, a first side115, a second side116, a first end113, and a second end114that defines a leading edge117between the first and second sides115and116. The first end113of the first and second blades107and108includes an aperture118therethrough that facilitates securing of the first blade107and the second blade108with the actuator109. The passage110between the first and second blades107and108in the second embodiment receives the bridge8of the implant5therein whereby the first and second blades107and108at their leading edges117extend beyond the bridge8such that the first and second blades107and108at their first and second sides115and116respectively abut the engagement points35,40,44, and50of the legs23-26, thereby constraining the implant5in its insertion shape7or53.

The actuator109as illustrated inFIGS.13A-13Bincludes a first slider120, a second slider121, and a spacer122whereby the first and second sliders120and121couple with the spacer122in opposed relationship to form the actuator109secured with the first and second blades107and108. The first and second sliders120and121each include first and second ends123and124, first and second sides125and126, and a front surface127defining a protrusion128that allows manipulation of the first and second sliders120and121, and a rear surface129defining a pin130and a peg131. The spacer122includes first and second ends132and133, first and second sides134and135, a front surface136, and a rear surface137. The spacer122further includes an opening138therethrough extending from its first side134to its second side135and a channel139therethrough extending from its first side134to its second side135. The pins130of the first and second sliders120and121are complementary in shape and produce a complementary fit with the opening138, whereas the pegs131of the first and second sliders120and121are complementary in shape and produce a complementary fit with both the aperture118of the first and second blades107and108and the channel139. The first slider120at its peg131receives thereon the first blade107via its aperture118, while the first slider120aligns with the spacer122at its first side134such that its pin130inserts into the opening138at the first side134of the spacer122and the peg131with the first blade107thereon inserts into the channel139at the first side134of the spacer122. Likewise, the second slider121at its peg131receives thereon the second blade108via its aperture118, while the second slider121aligns with the spacer122at its second side135such that its pin130inserts into the opening138at the second side135of the spacer122and the peg131with the second blade108thereon inserts into the channel139at the second side135of the spacer122. The securing of the first slider120at the first side134of the spacer122along with the first blade107in combination with the securing of the second slider121at the second side135of the spacer122along with the second blade108constructs the implant grip104. The spacer122in the second embodiment is dimensioned whereby the spacer122locates the first and second blades107and108such that the passage110therebetween receives therein the bridge8of the implant5.

The body103as illustrated inFIGS.12A-12Bincludes a first end145defining a handle146that facilitates grasping of the implant insertion device100during its use in implanting the implant5into bone, bones, or bone pieces requiring fixation. The body103includes a second end147defining a tamp148configured to engage the bridge8when the implant5resides in its insertion shape7or53. The body103includes a first surface149and a second surface150, which, in the second embodiment, are symmetrical and identical in shape. The body103defines a slot151therethrough communicating exterior to the body103that receives the implant grip104such that the implant grip104secures with the body103and is movable between its disengaged position105and its engaged position106. The slot151within the body103at an upper end152terminates in a first stop153and at a lower end154terminates in a second stop155. The slot151in the second embodiment is sized and shaped to receive therein the spacer122of the actuator109whereby the spacer122in combination with the first and second sliders120and121of the actuator109and the first and second blades107and108couple with the body103to form the actuator109and the implant grip104. The body103in the second embodiment may be a single piece or two symmetrical halves secured together using any suitable means such as an adhesive.

The slot151of the body103receives the implant grip104and secures the implant grip104with the body103as follows. The spacer122of the actuator109inserts into the slot151with the spacer122oriented whereby its first side134and the opening138and the channel139communicate exterior to the slot151at the first surface149of the body103and its second side135and the opening138and the channel139communicate exterior to the slot151at the second surface150of the body103. The first slider120at its peg131receives thereon the first blade107via its aperture118followed by placement of the first slider120adjacent the first surface149of the body103over the slot151such that its pin130inserts into the opening138at the first side134of the spacer122and the peg131with the first blade107thereon inserts into the channel139at the first side134of the spacer122. Likewise, the second slider121at its peg131receives thereon the second blade108via its aperture118followed by placement of the second slider121adjacent the second surface150of the body103over the slot151such that its pin130inserts into the opening138at the second side135of the spacer122and the peg131with the second blade108thereon inserts into the channel139at the second side135of the spacer122. The first and second sliders120and121at their pins130and pegs131accordingly frictionally engage the spacer122thereby forming the actuator109and coupling the actuator with the body103while also locating the first blade107at the first surface149of the body103and the second blade108at the second surface150of the body103to form the implant grip104; although an adhesive if desired may be introduced to aid in the securing of the first slider120with the second slider121.

With the first and second sliders120and121coupled together over the spacer122to form the actuator109, the actuator109frictionally engages the body103in order to introduce a resistance to the movement of the actuator109along the body103such that a force must be applied to the actuator109when moving the implant grip104between its disengaged position105and its engaged position106. In particular, the rear surfaces129of the first and second sliders120and121adjacent the pins130form a clasp156including a clasp surface157whereby the clasp156frictionally engages the body103in that the clasp surface157of the first slider120contacts the first surface149of the body103located about the slot151and the clasp surface157of the second slider121contacts the second surface150of the body103located about the slot151. The first and second surfaces149and150of the body103in the second embodiment may define a clasp receiver158configured specifically for frictional contact respectively with the clasp surface157of the clasp156defined by the first and second sliders120and121.

The coupling of the implant grip104with the first end132of the spacer122for the actuator109located adjacent the first stop153of the slot151produces the implant grip104configured in its disengaged position105as illustrated inFIGS.10A-10D. Furthermore, the frictional engagement of the clasp156for the actuator109with the body103prevents involuntary movement of the implant grip104from its disengaged position105such that the first and second blades107and108remain positioned at the second end147of the body103adjacent the tamp148and thus retracted relative to the body103. An application of a force to the actuator109(e.g., pushing on the actuator109) progresses the implant grip104from its disengaged position105to its engaged position106as illustrated inFIGS.11A-11D. More particularly, the actuator109moves along the body103towards the second stop155of the body103until the spacer122of the actuator109at its second end133contacts the second stop155such that the actuator109via its connection with the first and second blades107and108advances the first and second blades107and108exterior to the body103. In the second embodiment, the second stop155and the tamp148define a rectangular shape similar to the bridge8of the implant5but are dimensioned smaller than the passage110between the first and second blades107and108in order to allow the first and second blades107and108to by-pass the second stop155and the tamp148and extend exterior relative to the body103. An application of a force to the actuator109(e.g., pulling on the actuator109) or to first and second blades107and108at their leading edges117progresses the implant grip104from its engaged position106to its disengaged position105. More particularly, the actuator109moves along the body103away from the second stop155and towards103the first stop153until the spacer122of the actuator109at its first end132contacts the first stop153such that the actuator109retracts the first and second blades107and108to a position at the second end147of the body103adjacent the tamp148. When moving the implant grip104between its disengaged position105and its engaged position106, one of ordinary skill in the art will recognize that the actuator109due to its frictional engagement with the body103may be released at any point between the first stop153and the second stop155such that the first and second blades107and108extend from the body103at any location between the disengaged position105and the engaged position106.

When receiving the implant5in an orthopedic fixation system, the implant insertion device100as illustrated inFIGS.10A-10Dbegins in its unloaded position101wherein the implant grip104resides in its disengaged position105. The implant5is mechanically deformed from its natural shape6to its insertion shape7as illustrated inFIGS.2A-2Eor its insertion shape53as illustrated inFIG.2Fsuch that the implant5stores mechanical energy. Mechanical deformation of the implant5may include cooling of the implant5such that the implant5transitions from its austenite phase to its martensite phase prior to loading of the implant5on the implant insertion device100. After deformation of the implant5, the implant insertion device100is positioned adjacent the deformed implant5whereby the tamp148of the body103contacts the bridge8.

Once the body103of the implant insertion device100aligns with the bridge8of the implant5, a force applied to the implant grip104moves the implant grip104relative to the body103from its disengaged position105to its engaged position106resulting in the implant insertion device100as illustrated inFIGS.11A-11Dtransitioning from its unloaded position101to its loaded position102whereby the implant insertion device100retains the implant5in its insertion shape7or53. The implant grip104extends from the body103whereby the passage110between the first and second blades107and108permits the first and second blades107and108at their leading edges117to by-pass and then extend beyond the bridge8such that the first and second blades107and108respectively engage the legs23-26at their engagement points35,40,44, and50. More particularly, a force applied to the actuator109progresses the actuator109along the body103towards the second stop155of the body103until the spacer122of the actuator109at its second end133contacts the second stop155whereby the actuator109extends the first and second blades107and108exterior to the body103such that the first and second blades107and108at their first and second sides115and116respectively abut the engagement points35,40,44, and50of the legs23-26, thereby constraining the implant5in its insertion shape7or53. In the second embodiment, the first and second blades107and108at their first faces111defining the passage110may be spaced apart a distance that allows the first and second blades107and108at their first faces111to frictionally engage the bridge8at its first and second sides11and12.

While the implant5may be mechanically deformed from its natural shape6to its insertion shape7or53prior to its loading on the implant insertion device100, the implant insertion device100may be employed during its loading with the implant5to mechanically deform the implant5from its natural shape6to its insertion shape7or53. The implant insertion device100is positioned adjacent the implant5in its natural shape6whereby the tamp148of the body103contacts the bridge8. Once the body103of the implant insertion device100aligns with the bridge8of the implant5, a force applied to the implant grip104moves the implant grip104relative to the body103. As a result, the implant grip104extends from the body103such that the passage110between the first and second blades107and108receives the bridge8therein while the first and second blades107and108at their leading edges117by-pass and then extend beyond the bridge8to respectively engage the legs23-26at their engagement points35,40,44, and50. More particularly, a force applied to the actuator109progresses the actuator109along the body103towards the second stop155of the body103until the spacer122of the actuator109at its second end133contacts the second stop155whereby the actuator109extends the first and second blades107and108exterior to the body103such that the first and second blades107and108at their first and second sides115and116respectively abut the engagement points35,40,44, and50of the legs23-26. Moreover, due to the force imparted to the first and second blades107and108via the actuator109, the first and second blades107and108via their abutment with the engagement points35,40,44, and50of the legs23-26deform the implant5, thereby transitioning the implant5from its natural shape6to its insertion shape7or53and constraining the implant5as illustrated inFIGS.11A-11D.

When delivering the implant5to bone, bones, or bone pieces, the implant insertion device100as illustrated inFIGS.11A-11Dbegins in its loaded position102wherein the implant grip104in its engaged position106constrains the implant5in its insertion shape7or53. In order to release the implant5from the implant insertion device100, a force applied to the implant grip104either at the leading edges117of the first and second blades107and108or the actuator109progresses the implant grip104from its engaged position106to its disengaged position105. The implant grip104disengages from the implant5and retracts relative to the body103such that the implant grip104releases the legs23-26at their engagement points35,40,44, and50and also the bridge8if engaged therewith resulting in an attempted transition of the implant5from its insertion shape7or53to its natural shape6whereby the implant5delivers the energy stored therein to the bone, bones, or bone pieces. More particularly, progression of the actuator109along the body103to the first stop154thereof moves the first and second blades107and108such that the first and second blades107and108at their first and second sides115and116respectively release the engagement points35,40,44, and50of the legs23-26while, if engaged, the first and second blades107and108at their first faces111also release the bridge8. The first and second blades107and108retract to a position at the second end147of the body103adjacent the tamp148whereby the released implant5delivers the energy stored therein to the bone, bones, or bone pieces.

FIGS.14A-14Eillustrate an orthopedic implant175according to a second embodiment in a natural shape176, whereasFIGS.15A-15Eillustrate the orthopedic implant175in an insertion shape177. The implant175in the second embodiment may be manufactured from a shape memory material with superelastic or temperature dependent properties (e.g., Nitinol) such that the implant175transitions between its natural shape176and its insertion shape177. The implant175when deformed from its natural shape176to its insertion shape177stores energy deliverable to bone, bones, or bone pieces. In accordance with its manufacture from shape memory material, the implant175begins in its natural shape176, is transitionable to its insertion shape177, and, once implanted in bone, bones, or bone pieces, attempts to transition from its insertion shape177to its natural shape176whereby the implant175delivers the energy stored therein to the bone, bones, or bone pieces in order to affix the bone, bones, or bone pieces and promote a healing thereof. In the first embodiment, attempted transition of the implant175from its insertion shape177to its natural shape176continuously compresses the bone, bones, or bone pieces to promote fusion thereof.

The implant175includes a bridge178with upper and lower surfaces179and180, first and second sides181and182, and first and second ends183and184. The implant175further includes a transition section185at the first end183of the bridge178and a transition sections186at the second end184of the bridge178. The implant175in the second embodiment includes an anchoring member in the form of a leg187extending from the first end183and, in particular, the transition section185and an anchoring member in the form of a leg188extending from the second end184and, in particular, the transition section186. In the second embodiment, the legs187-188are formed integrally with the bridge8at a respective first and second end183-184and, in particular, at a respective transition section185-186. Each leg187-188, which has a respective tip189-190, may include barbs thereon that improve the pull-out resistance of the implant175. The implant175includes anchoring members in the form of the legs187-188in order to facilitate a securing of the implant175with bone, bones, or bone pieces whereby the bridge178between the legs187-188traverses a fixation zone of the bone, bones, or bone pieces such that the implant175, after its insertion and attempted transition from the insertion shape177to the natural shape176, delivers energy to the bone, bones, or bone pieces at the fixation zone.

The leg187in the second embodiment includes a width191between sides192and193such that a first segment194of the leg187extends exterior to the bridge178at its first side181and a second segment195of the leg187extends exterior to the bridge178at its second side182. The first segment194provides an engagement point196whereby an implant engagement device by-passes the bridge178at its first side181and abuts the engagement point196. Likewise, the second segment195provides an engagement point197whereby an implant engagement device by-passes the bridge178at its second side182and abuts the engagement point197. The leg188in the second embodiment includes a width198between sides199and200such that a first segment201of the leg188extends exterior to the bridge178at its first side181and a second segment202of the leg188extends exterior to the bridge178at its second side182. The first segment201provides an engagement point203whereby an implant engagement device by-passes the bridge178at its first side181and abuts the engagement point203. Likewise, the second segment202provides an engagement point204whereby an implant engagement device by-passes the bridge178at its second side182and abuts the engagement point204. While the legs187-188in the second embodiment respectively include engagement points196-197and203-204, one of ordinary skill in the art will recognize that legs187-188respectively may include one engagement point196or197and203or204whereby an implant engagement device by-passes the bridge178and abuts respectively one the engagement points196or197and203or204.

The regular inherent shape of the implant175, as illustrated inFIGS.14A-14E, is its natural shape176where the transition sections185-186locate the bridge178in a natural form that places the legs187-188in a natural position whereby the legs187-188are convergent and spaced apart at a first distance. Nevertheless, as illustrated inFIGS.15A-15E, the implant175is deformable under the action of superelasticity or temperature dependent shape memory to an insertion shape177where the transition sections185-186deform to store energy while also moving the bridge178from its natural form to an insertion form that places the legs187-188in an insertion position whereby the legs187-188are substantially parallel and spaced apart at a second distance that is greater than the first distance. Since the insertion shape177is not the regular inherent shape of the implant175, the bridge178typically is mechanically constrained using an implant insertion device whereby the implant insertion device maintains the bridge178in its insertion form. In order to facilitate engagement of an implant insertion device with the implant175, the legs187-188, respectively, include engagement points196-197and203-204that receive the implant insertion device. The implant insertion device by-passes the bridge178at its first and second sides181and182and abuts the engagement points196-197and203-204. In particular, the implant insertion device extends beyond the bridge178at its first and second sides181and182and abuts the engagement points196-197and203-204such that the implant insertion device engages and then holds the legs187-188, resulting in the implant insertion device constraining the deformed transition sections185-186in order to maintain the implant175in its insertion shape177. After implantation into bone, bones, or bone pieces and a release of the implant insertion device, including if necessary a heating of the implant175, the implant175delivers the energy stored in the transition sections185-186whereby the bridge178attempts to transition from its insertion form to its natural form, which causes an attempt of the legs187-188to move from their insertion position to their natural position such that the implant175affixes the bone, bones, or bone pieces through an application of a compressive force thereto.

Although the bridge178of the implant175according to the second embodiment includes the transition sections185-186, the bridge178, alternatively, may include a transition section205located at a center section206of the implant175and thus the bridge178. The regular inherent shape of the implant175, as illustrated inFIGS.14A-14E, is its natural shape6where the transition section205locates the bridge178in a natural form consisting of a closed or angular profile whereby the first and second ends183and184reside at a first distance and the legs187-188reside in a natural position whereby the legs187-188are convergent and spaced apart at a first distance. Nevertheless, as illustrated inFIG.15F, the implant175is deformable under the action of superelasticity or temperature dependent shape memory to an insertion shape207where the transition section205deforms to store energy while also moving the bridge178from its natural form to an insertion form which is an open or substantially linear profile whereby the first and second ends183and184reside at a second distance that is greater than the first distance and the legs187-188reside in an insertion position whereby the legs187-188are substantially parallel and spaced apart at a second distance that is greater than the first distance. Since the insertion shape207is not the regular inherent shape of the implant175, the bridge178typically is mechanically constrained using an implant insertion device whereby the implant insertion device maintains the bridge178in its insertion form. In order to facilitate engagement of an implant insertion device with the implant175, the legs187-188, respectively, include the engagement points196-197and203-204that receive the implant insertion device. The implant insertion device by-passes the bridge178at its first and second sides181and182and abuts the engagement points196-197and203-204. In particular, the implant insertion device extends beyond the bridge178at its first and second sides181and182and abuts the engagement points196-197and203-204such that the implant insertion device engages and then holds the legs187-188, resulting in the implant insertion device constraining the deformed transition section205in order to maintain the implant175in its insertion shape177. After implantation into bone, bones, or bone pieces and a release of the implant insertion device, including if necessary a heating of the implant175, the implant175delivers the energy stored in the transition section205whereby the bridge178attempts to transition from its insertion form to its natural form, which causes an attempt of the legs187-188to move from their insertion position to their natural position such that the implant175affixes the bone, bones, or bone pieces through an application of a compressive force thereto.

While the second embodiment of the implant175includes either the transition sections185-186or the transition section205to produce deformation thereof, one of ordinary skill in the art will recognize that the bridge178of the implant175may include both the transition sections185-186and the transition section205to produce deformation thereof. Moreover, while the bridge178in the second embodiment includes an angular profile in the natural shape of the implant175, it should be understood by one of ordinary skill in the art that a bridge178incorporating the transition sections185-186may include a substantially linear profile for the natural shape of the implant175.

FIGS.16A-18Dillustrate an implant insertion device208according to a third embodiment that engages an implant175and retains the implant175in its insertion shape177or207.FIGS.17A-17Billustrate the implant insertion device208in an unloaded position209prior to its loading with the implant175or after its delivery of the implant175whereby the implant175releases from the implant insertion device208without obstruction.FIGS.18A-18Dillustrate the implant insertion device208in a loaded position210whereby the implant insertion device208may be loaded with the implant175such that the implant insertion device208constrains the implant175in its insertion shape177or207. The implant insertion device208allows a surgeon to manipulate the implant175and insert the implant175into bone, bones, or bone pieces requiring fixation.FIGS.19A-19Dillustrate a body211of the implant insertion device208, whereasFIGS.20A-22Billustrates an implant grip212of the implant insertion device208that is coupled with the body211and is movable relative to the body211between a disengaged position213shown inFIGS.17A-17Band an engaged position214shown inFIGS.18A-18D.

The implant insertion device208according to the third embodiment, including its body211and implant grip212, is substantially similar in design and operation relative to the implant insertion device60according to the first embodiment, including its body63and implant grip64, such that, for the sake of brevity, only differences therebetween will be described herein. Moreover, one of ordinary skill in the art will recognize that like parts of the body211and the implant grip212for the implant insertion device208labeled with like numerals of the body63and the implant grip64for the implant insertion device60incorporate a design and function as previously set forth in the detailed description of the implant insertion device60according to the first embodiment.

The implant grip212as illustrated inFIGS.20A-22Bis substantially similar to the implant grip64with the exception of the following. The implant grip212, which includes the shell67with the interior surface69defining the passage70therethrough, the grooves71-74, the retention surfaces79-82, and the detents87and88, interfaces with the implant175and the body211, whereas the implant grip64interfaces with the implant5and the body63. In accordance therewith, the interior surface69of the shell67and thus the passage70include a shape complimentary with the implant175and, in particular, with the first and second sides181and182and the first and second ends183and184of the bridge178whereby the shell67grips the implant175and retains therein the implant175in its insertion shape177or207. The grooves71-72located respectively at the corners75-76of the interior surface69respectively receive therein the segments194-195of the leg187for the implant175and frictionally engage the segments194-195thereby retaining the implant175within the shell67, while the grooves73-74located respectively at the corners77-78of the interior surface69respectively receive therein the segments201-202of the leg188for the implant175and frictionally engage the segments201-202thereby retaining the implant175within the shell67. The retention surfaces79-80respectively abut an engagement point196-197of the leg187for the implant175in order to grip and then constrain the leg187such that the shell67retains the implant175in its insertion shape177or207, while the retention surfaces81-82respectively abut an engagement point203-204of the leg188for the implant175in order to grip and then constrain the leg188such that the shell67retains the implant175in its insertion shape177or207. The detents87-88engage the body211to assist in coupling the shell67with the body211and further to limit the motion of the shell67relative to the body211as the implant grip212moves between its disengaged position213and its engaged position214. The shell67for the implant grip212at its interior surface69does not incorporate the projections83-86on the basis the implant175includes only two legs187-188.

The body211as illustrated inFIGS.19A-19Dis substantially similar to the body63with the exception of the following. The body211, which includes the first end75defining the handle76and the second end77defining the implant grip receiver78with the tamp79and a stop84, interfaces with the implant grip212and the implant175, whereas the body63interfaces with the implant grip64and the implant5. In accordance therewith, the implant grip receiver78and thus the first and second sides80and81and the first and second ends82and83thereof include a shape complimentary with the implant grip212and, in particular, with the interior surface69of the shell67whereby the implant grip receiver78receives and then retains the implant grip212thereon. The tamp79includes a configuration for engagement with the bridge178when the implant175resides in its insertion shape177or its insertion shape207. The notches91and92aid in retaining the shell67on the implant grip receiver78and further locate the implant grip212in either its disengaged position213or its engaged position214. In the third embodiment of the implant insertion device208, the length of the implant grip receiver78for the body211substantially equals the length of the implant grip212.

The implant insertion device208according to the third embodiment loads with the implant175, constrains the implant175in its insertion position177or207, and transitions from its loaded position210to its unloaded position209thereby delivering the implant175to bone, bones, or bone pieces substantially identical to the implant insertion device60according to the first embodiment as previously set forth in the detailed description thereof. During loading of the implant insertion device208with the implant175and a subsequent retention thereof, the tamp79of the implant grip receiver78for the body211sits atop the bridge178of the implant175, while the grooves71-74maintain the implant175within the implant grip212and the retention surfaces79-82in each of the grooves71-74defined by the shell67constrain the legs187-188such that the shell67holds the implant175in its insertion shape177or207. When delivering the implant175to bone, bones, or bone pieces, the retention surfaces79-82disposed in each of the grooves71-74respectively release an engagement point196-197and203-204of the legs187-188, while the grooves71-74of the interior surface69for the shell67respectively disengage from a segment194-195and201-202of the legs187-188. Moreover, the interior surface69of the shell67disengages from the first and second sides181and182of the bridge178, whereas the interior surface69of the shell67further by-passes the bridge178of the implant175at its first and second sides181and182and its first and second ends183and184such that the implant175exits the passage70of the shell67, resulting in the discharge of the implant175from the implant grip212and a subsequent attempted transition of the implant175from its insertion shape177or207to its natural shape176whereby the implant175delivers the energy stored therein to the bone, bones, or bone pieces.

FIGS.23A-24Dillustrate an implant insertion device300according to a fourth embodiment that engages the implant175and retains the implant175in its insertion shape177or207.FIGS.23A-23Dillustrate the implant insertion device300in an unloaded position301prior to its loading with the implant175or after its delivery of the implant175whereby the implant175releases from the implant insertion device300without obstruction.FIGS.24A-24Dillustrate the implant insertion device300in a loaded position302whereby the implant insertion device300may be loaded with the implant175such that the implant insertion device300retains the implant175in its insertion shape177or207. The implant insertion device300allows a surgeon to manipulate the implant175and insert the implant175into bone, bones, or bone pieces requiring fixation.FIGS.25A-25Billustrate a body303of the implant insertion device300, whereasFIGS.26A-26Billustrate an implant grip304of the implant insertion device300that is coupled with the body303and is movable relative to the body303between a disengaged position305shown inFIGS.23A-23Dand an engaged position306shown inFIGS.24A-24D.

The implant insertion device300according to the fourth embodiment, including its body303and implant grip304, is substantially similar in design and operation relative to the implant insertion device100according to the second embodiment, including its body103and implant grip104, such that, for the sake of brevity, only differences therebetween will be described herein. Moreover, one of ordinary skill in the art will recognize that like parts of the body303and the implant grip304for the implant insertion device300labeled with like numerals of the body103and the implant grip104for the implant insertion device100incorporate a design and function as previously set forth in the detailed description of the implant insertion device100according to the second embodiment.

The implant grip304as illustrated inFIGS.26A-26Bis substantially similar to the implant grip104with the exception of the following. The implant grip304, which includes the first and second blades107and108defining the passage110therebetween and the actuator109, interfaces with the implant175and the body303, whereas the implant grip104interfaces with the implant175and the body103. In accordance therewith, the actuator109in the fourth embodiment and, more particularly, the spacer122thereof is dimensioned whereby the spacer122locates the first and second blades107and108such that the passage110therebetween receives therein the bridge178of the implant175. The passage110in the fourth embodiment therefore is dimensioned to receive therein the bridge178of the implant175whereby the first and second blades107and108at their leading edges117extend beyond the bridge178such that the first blade107at its first and second sides115and116respectively abuts the engagement points196and203of the legs187-188for the implant175and the second blade108at its first and second sides115and116respectively abut the engagement points197-204of the legs187-188for the implant175, thereby constraining the implant175in its insertion shape177or207.

The body303as illustrated inFIGS.25A-25Bis substantially similar to the body103with the exception of the following. The body303, which includes the first end145defining the handle146and the second end147defining the tamp148, interfaces with the implant grip304and the implant175, whereas the body103interfaces with the implant grip104and the implant5. In accordance therewith, the body303is dimensioned relative to the implant175such that the tamp79is configured to engage the bridge178when the implant175resides in its insertion shape177or its insertion shape207. Likewise, the body303and, more particularly, the slot151is dimensioned relative to the implant grip304such that the spacer122of the actuator109inserts into the slot151with the spacer122oriented whereby its first side134and the opening138and the channel139communicate exterior to the slot151at the first surface149of the body303and its second side135and the opening138and the channel139communicate exterior to the slot151at the second surface150of the body303. Moreover, the second stop155and the tamp148of the body303in the fourth embodiment define a rectangular shape similar to the bridge178of the implant175but are dimensioned smaller than the passage110between the first and second blades107and108in order to allow the first and second blades107and108to by-pass the second stop155and the tamp148and extend exterior relative to the body303.

The implant insertion device300according to the fourth embodiment loads with the implant175, constrains the implant175in its insertion position177or207, and transitions from its loaded position302to its unloaded position301thereby delivering the implant175to bone, bones, or bone pieces substantially identical to the implant insertion device100according to the second embodiment as previously set forth in the detailed description thereof. During loading of the implant insertion device300with the implant175and a subsequent retention thereof, the tamp148of the body303sits atop the bridge178of the implant175, while the actuator109progresses along the body303towards the second stop155of the body303until the spacer122of the actuator109at its second end133contacts the second stop155whereby the actuator109extends the first and second blades107and108exterior to the body303such that the first and second blades107and108at their first and second sides115and116respectively abut the engagement points196-197and203-204of the legs187-188for the implant175, thereby constraining the implant175in its insertion shape177or207. When delivering the implant175to bone, bones, or bone pieces, the actuator109progresses along the body303to the first stop154thereof such that the first and second blades107and108at their first and second sides115and116respectively release the engagement points196-197and203-204of the legs187-188for the implant175while, if engaged, the first and second blades107and108at their first faces111also release the bridge178, resulting in the discharge of the implant175from the implant grip304and a subsequent attempted transition of the implant175from its insertion shape177or207to its natural shape176whereby the implant175delivers the energy stored therein to the bone, bones, or bone pieces.

FIGS.27A-27Eillustrate an orthopedic implant215according to a third embodiment in a natural shape216, whereasFIGS.28A-28Eillustrate the orthopedic implant215in an insertion shape217. The implant215in the third embodiment may be manufactured from a shape memory material with superelastic or temperature dependent properties (e.g., Nitinol) such that the implant215transitions between its natural shape216and its insertion shape217. The implant215when deformed from its natural shape216to its insertion shape217stores energy deliverable to bone, bones, or bone pieces. In accordance with its manufacture from shape memory material, the implant215begins in its natural shape216, is transitionable to its insertion shape217, and, once implanted in bone, bones, or bone pieces, attempts to transition from its insertion shape217to its natural shape216whereby the implant215delivers the energy stored therein to the bone, bones, or bone pieces in order to affix the bone, bones, or bone pieces and promote a healing thereof. In the first embodiment, attempted transition of the implant215from its insertion shape217to its natural shape216continuously compresses the bone, bones, or bone pieces to promote fusion thereof.

The implant215includes a bridge218with upper and lower surfaces219and220, first and second sides221and222, and first and second ends223and224. The first and second sides221and222and the first and second ends223and224in the third embodiment of the implant215define a substantially triangular shape. The bridge218at its first end223includes a concave section223a. The implant215further includes transition sections225and226at the first end223of the bridge218and a transition section227at the second end224of the bridge218. More particularly, in the third embodiment, the transition section225resides at a corner229of the bridge218at its first end223, whereas the transition section226resides at a corner230of the bridge218at its first end223. Similarly, the transition section227resides at a corner231of the bridge218at its first end224.

The implant215in the third embodiment includes an anchoring member in the form of a leg232extending from the corner229and, in particular, the transition section225at the corner229; an anchoring member in the form of a leg233extending from the corner230and, in particular, the transition section226at the corner230; and an anchoring member in the form of a leg234extending from the corner231and, in particular, the transition section227at the corner231. In the third embodiment, the legs232-234are formed integrally with the bridge218at a respective corner229-231and, in particular, at a respective transition section225-227. Each leg232-234, which has a respective tip235-237, may include barbs thereon that improve the pull-out resistance of the implant215. The implant215includes anchoring members in the form of the legs232-234in order to facilitate a securing of the implant215with bone, bones, or bone pieces whereby the bridge218between the legs232-234traverses a fixation zone of the bone, bones, or bone pieces such that the implant215, after its insertion and attempted transition from the insertion shape217to the natural shape216, delivers energy to the bone, bones, or bone pieces at the fixation zone.

The leg232in the third embodiment includes a width238between sides239and240such that a segment241of the leg232extends exterior to the bridge218at its first side221in order to provide an engagement point242whereby an implant engagement device by-passes the bridge218at its first side221and abuts the engagement point242. The leg233in the third embodiment includes a width243between sides244and245such that a segment246of the leg233extends exterior to the bridge218at its second side222in order to provide an engagement point247whereby an implant engagement device by-passes the bridge218at its second side222and abuts the engagement point247. The leg234in the third embodiment includes a width248between sides249and250such that a first segment251of the leg234extends exterior to the bridge218at its first side221and a second segment252of the leg234extends exterior to the bridge218at its second side222. The first segment251provides an engagement point253whereby an implant engagement device by-passes the bridge218at its first side221and abuts the engagement point253. Likewise, the second segment252provides an engagement point254whereby an implant engagement device by-passes the bridge218at its second side222and abuts the engagement point254. While the leg234in the third embodiment includes engagement points253-254, one of ordinary skill in the art will recognize that leg may include one engagement point253or254whereby an implant engagement device by-passes the bridge218and abuts one of the engagement points253or254.

The regular inherent shape of the implant215, as illustrated inFIGS.27A-27E, is its natural shape216where the transition sections225-227locate the bridge218in a natural form that places the legs232-234in a natural position whereby the legs232-233are convergent with the leg234and spaced apart from the leg234at a first distance. Nevertheless, as illustrated inFIGS.28A-28E, the implant215is deformable under the action of superelasticity or temperature dependent shape memory to an insertion shape217where the transition sections225-227deform to store energy while also moving the bridge218from its natural form to an insertion form that places the legs232-234in an insertion position whereby the legs232-233are substantially parallel with the leg234and spaced apart from the leg234at a second distance that is greater than the first distance. Since the insertion shape217is not the regular inherent shape of the implant215, the bridge218typically is mechanically constrained using an implant insertion device whereby the implant insertion device maintains the bridge218in its insertion form. In order to facilitate engagement of an implant insertion device with the implant215, the legs232-233, respectively, include the engagement points242and247and the leg234respectively includes the engagement points253and254that receive the implant insertion device. The implant insertion device by-passes the bridge218at its first and second sides221and222and abuts the engagement points242,247,253, and254. In particular, the implant insertion device extends beyond the bridge218at its first and second sides221and222and abuts the engagement points242,247,253, and254such that the implant insertion device engages and then holds the legs232-234, resulting in the implant insertion device constraining the deformed transition sections225-227in order to maintain the implant215in its insertion shape217. After implantation into bone, bones, or bone pieces and a release of the implant insertion device, including if necessary a heating of the implant215, the implant215delivers the energy stored in the transition sections225-227whereby the bridge218attempts to transition from its insertion form to its natural form, which causes an attempt of the legs232-234to move from their insertion position to their natural position such that the implant215affixes the bone, bones, or bone pieces through an application of a compressive force thereto.

Although the bridge218of the implant215according to the third embodiment includes the transition sections225-227, the bridge218, alternatively, may include a transition section255located at a center section256of the implant215and thus the bridge218. The regular inherent shape of the implant215, as illustrated inFIGS.27A-27E, is its natural shape216where the transition section255locates the bridge218in a natural form consisting of a closed or angular profile whereby the first and second ends223and224reside at a first distance and the legs232-234reside in a natural position whereby the legs232-233are convergent with the leg234and spaced apart from the leg234at a first distance. Nevertheless, as illustrated inFIG.28F, the implant215is deformable under the action of superelasticity or temperature dependent shape memory to an insertion shape257where the transition section255deforms to store energy while also moving the bridge218from its natural form to an insertion form which is an open or substantially linear profile whereby the first and second ends223and224reside at a second distance that is greater than the first distance and the legs232-234reside in an insertion position whereby the legs232-233are substantially parallel with the leg234and spaced apart from the leg234at a second distance that is greater than the first distance. Since the insertion shape257is not the regular inherent shape of the implant215, the bridge218typically is mechanically constrained using an implant insertion device whereby the implant insertion device maintains the bridge218in its insertion form. In order to facilitate engagement of an implant insertion device with the implant215, the legs232-233, respectively, include the engagement points242and247and the leg234respectively includes the engagement points253and254that receive the implant insertion device. The implant insertion device by-passes the bridge218at its first and second sides221and222and abuts the engagement points242,247,253, and254. In particular, the implant insertion device extends beyond the bridge218at its first and second sides221and222and abuts the engagement points242,247,253, and254such that the implant insertion device engages and then holds the legs232-234, resulting in the implant insertion device constraining the deformed transition section255in order to maintain the implant215in its insertion shape257. After implantation into bone, bones, or bone pieces and a release of the implant insertion device, including if necessary a heating of the implant215, the implant215delivers the energy stored in the transition section255whereby the bridge218attempts to transition from its insertion form to its natural form, which causes an attempt of the legs232-234to move from their insertion position to their natural position such that the implant215affixes the bone, bones, or bone pieces through an application of a compressive force thereto.

While the third embodiment of the implant215includes either the transition sections225-227or the transition section255to produce deformation thereof, one of ordinary skill in the art will recognize that the bridge218of the implant215may include both the transition sections225-227and the transition section255to produce deformation thereof. Moreover, while the bridge218in the third embodiment includes an angular profile in the natural shape of the implant215, it should be understood by one of ordinary skill in the art that a bridge218incorporating the transition sections225-227may include a substantially linear profile for the natural shape of the implant215.

FIGS.29A-31Dillustrate an implant insertion device400according to a fifth embodiment that engages an implant215and retains the implant215in its insertion shape217or257.FIGS.30A-30Billustrate the implant insertion device400in an unloaded position401prior to its loading with the implant215or after its delivery of the implant215whereby the implant215releases from the implant insertion device400without obstruction.FIGS.31A-31Dillustrate the implant insertion device400in a loaded position402whereby the implant insertion device400may be loaded with the implant215such that the implant insertion device400constrains the implant215in its insertion shape217or257. The implant insertion device400allows a surgeon to manipulate the implant215and insert the implant215into bone, bones, or bone pieces requiring fixation.FIGS.32A-32Dillustrate a body403of the implant insertion device400, whereasFIGS.33A-35Billustrate an implant grip404of the implant insertion device400that is coupled with the body403and is movable relative to the body403between a disengaged position405shown inFIGS.30A-30Band an engaged position406shown inFIGS.31A-31D.

The implant insertion device400according to the fourth embodiment, including its body403and implant grip404, is substantially similar in design and operation relative to the implant insertion device60according to the first embodiment, including its body63and implant grip64, such that, for the sake of brevity, only differences therebetween will be described herein. Moreover, one of ordinary skill in the art will recognize that like parts of the body403and the implant grip404for the implant insertion device400labeled with like numerals of the body63and the implant grip64for the implant insertion device60incorporate a design and function as previously set forth in the detailed description of the implant insertion device60according to the first embodiment.

The implant grip404as illustrated inFIGS.33A-35Bis substantially similar to the implant grip64with the exception of the following. The implant grip212, which includes the shell67with the interior surface69defining the passage70therethrough, the grooves71-74, the retention surfaces79-82, and the detents87and88, interfaces with the implant215and the body403, whereas the implant grip64interfaces with the implant5and the body63. In accordance therewith, the interior surface69of the shell67and thus the passage70include a shape complimentary with the implant215, substantially triangular in the fifth embodiment, and, in particular, with the first and second sides181and182and the first and second ends183and184of the bridge178whereby the shell67grips the implant175and retains therein the implant175in its insertion shape177or207. The grooves71-72located respectively at the corners75-76of the interior surface69respectively receive therein the segments241and246of the legs232-233for the implant215and frictionally engage the segments241and246thereby retaining the implant215within the shell67, while the grooves73-74located respectively at the corners77-78of the interior surface69respectively receive therein the segments251-252of the leg234for the implant215and frictionally engage the segments251-252thereby retaining the implant215within the shell67. The retention surfaces79-80respectively abut an engagement point242and247of the legs232-233for the implant215in order to grip and then constrain the legs232-233such that the shell67retains the implant215in its insertion shape217or257, while the retention surfaces81-82respectively abut an engagement point253-254of the leg234for the implant215in order to grip and then constrain the leg234such that the shell67retains the implant215in its insertion shape217or257. The detents87-88engage the body403to assist in coupling the shell67with the body63and further to limit the motion of the shell67relative to the body403as the implant grip404moves between its disengaged position405and its engaged position406. The shell67for the implant grip404at its interior surface69incorporates the projections83-84on the basis the implant215includes the two legs232-233at the first end223of the bridge218. The shell67for the implant grip404at its interior surface69does not incorporate projections85-86on the basis the implant215includes only the leg234at the second end224of the bridge218.

The body403as illustrated inFIGS.32A-32Dis substantially similar to the body63with the exception of the following. The body403, which includes the first end75defining the handle76and the second end77defining the implant grip receiver78with the tamp79and a stop84, interfaces with the implant grip404and the implant215, whereas the body63interfaces with the implant grip64and the implant5. In accordance therewith, the implant grip receiver78and thus the first and second sides80and81and the first and second ends82and83thereof include a shape complimentary with the implant grip404, substantially triangular in the fifth embodiment, and, in particular, with the interior surface69of the shell67whereby the implant grip receiver78receives and then retains the implant grip404thereon. The tamp79includes a configuration, substantially triangular in the fifth embodiment, for engagement with the bridge218when the implant215resides in its insertion shape217or its insertion shape257. The notches91and92aid in retaining the shell67on the implant grip receiver78and further locate the implant grip404in either its disengaged position405or its engaged position406. In the fifth embodiment of the implant insertion device400, the length of the implant grip receiver78for the body403substantially equals the length of the implant grip404.

The implant insertion device400according to the fifth embodiment loads with the implant215, constrains the implant215in its insertion position217or257, and transitions from its loaded position402to its unloaded position401thereby delivering the implant215to bone, bones, or bone pieces substantially identical to the implant insertion device60according to the first embodiment as previously set forth in the detailed description thereof. During loading of the implant insertion device400with the implant215and a subsequent retention thereof, the tamp79of the implant grip receiver78for the body403sits atop the bridge218of the implant215, while the grooves71-74maintain the implant215within the implant grip404and the retention surfaces79-82in each of the grooves71-74defined by the shell67constrain the legs232-234such that the shell67holds the implant215in its insertion shape217or257. The projections83-84of the interior surface69by-pass the bridge218at its first end223via the concave sections13aand14athereof and then frictionally engage a respective leg232-233opposite from the segments241and246, thereby assisting in retaining the implant5within the shell67in its insertion shape217or257. When delivering the implant175to bone, bones, or bone pieces, the projections83-84of the interior surface69by-pass respectively the bridge218at its first end223via the concave section223aand insert into the indentation93in the implant grip receiver78, thereby releasing a respective leg232-233opposite from the segments241and246. Likewise, the retention surfaces79-82disposed in each of the grooves71-74respectively release an engagement point242,247,253, and254of the legs232-234, while the grooves71-74of the interior surface69for the shell67respectively disengage from a segment241,246,251, and253of the legs232-234. Moreover, the interior surface69of the shell67disengages from the first and second sides221and222of the bridge218, whereas the interior surface69of the shell67further by-passes the bridge218of the implant215at its first and second sides221and222and its first and second ends223and224such that the implant215exits the passage70of the shell67, resulting in the discharge of the implant215from the implant grip404and a subsequent attempted transition of the implant215from its insertion shape217or257to its natural shape216whereby the implant215delivers the energy stored therein to the bone, bones, or bone pieces.

FIGS.36A-37Dillustrate an implant insertion device500according to a sixth embodiment that engages the implant215and retains the implant215in its insertion shape217or257.FIGS.36A-36Dillustrate the implant insertion device500in an unloaded position501prior to its loading with the implant215or after its delivery of the implant215whereby the implant215releases from the implant insertion device500without obstruction.FIGS.37A-37Dillustrate the implant insertion device500in a loaded position502whereby the implant insertion device500may be loaded with the implant215such that the implant insertion device500retains the implant215in its insertion shape217or257. The implant insertion device500allows a surgeon to manipulate the implant215and insert the implant215into bone, bones, or bone pieces requiring fixation.FIGS.38A-38Billustrate a body503of the implant insertion device500, whereasFIGS.39A-39Billustrate an implant grip504of the implant insertion device300that is coupled with the body503and is movable relative to the body503between a disengaged position505shown inFIGS.36A-36Dand an engaged position506shown inFIGS.37A-37D.

The implant insertion device500according to the sixth embodiment, including its body503and implant grip504, is substantially similar in design and operation relative to the implant insertion device100according to the second embodiment, including its body103and implant grip104, such that, for the sake of brevity, only differences therebetween will be described herein. Moreover, one of ordinary skill in the art will recognize that like parts of the body503and the implant grip504for the implant insertion device500labeled with like numerals of the body103and the implant grip104for the implant insertion device100incorporate a design and function as previously set forth in the detailed description of the implant insertion device100according to the second embodiment.

The implant grip504as illustrated inFIGS.38A-38Bis substantially similar to the implant grip104with the exception of the following. The implant grip504, which includes the first and second blades107and108defining the passage110therebetween and the actuator109, interfaces with the implant215and the body503, whereas the implant grip104interfaces with the implant175and the body103. In accordance therewith, the first and second blades107and108at their first faces111include a projection510extending therefrom, which, in the sixth embodiment, is substantially triangular. The first faces111and their projections510define the passage110whereby the passage110is complimentary in shape with the bridge218of the implant215in order to receive the implant215therein. The actuator109in the fourth embodiment and, more particularly, the spacer122thereof is dimensioned whereby the spacer122locates the first and second blades107and108such that the passage110therebetween receives therein the bridge218of the implant215. The passage110in the sixth embodiment therefore is dimensioned to receive therein the bridge218of the implant215whereby the first and second blades107and108at their leading edges117extend beyond the bridge218such that the first blade107at its first and second sides115and116respectively abuts the engagement points242and253of the legs232and234for the implant215and the second blade108at its first and second sides115and116respectively abut the engagement points247and254of the legs233and234for the implant215, thereby constraining the implant215in its insertion shape217or257.

The body503as illustrated inFIGS.38A-38Bis substantially similar to the body103with the exception of the following. The body503, which includes the first end145defining the handle146and the second end147defining the tamp148, interfaces with the implant grip504and the implant215, whereas the body103interfaces with the implant grip104and the implant5. In accordance therewith, the body503is dimensioned relative to the implant215such that the tamp79is configured to engage the bridge218when the implant215resides in its insertion shape217or its insertion shape257. Likewise, the body503and, more particularly, the slot151is dimensioned relative to the implant grip504such that the spacer122of the actuator109inserts into the slot151with the spacer122oriented whereby its first side134and the opening138and the channel139communicate exterior to the slot151at the first surface149of the body503and its second side135and the opening138and the channel139communicate exterior to the slot151at the second surface150of the body503. Moreover, the second stop155and the tamp148of the body503in the sixth embodiment define a triangular shape similar to the bridge218of the implant215but are dimensioned smaller than the passage110between the first and second blades107and108in order to allow the first and second blades107and108to by-pass the second stop155and the tamp148and extend exterior relative to the body503.

The implant insertion device500according to the sixth embodiment loads with the implant215, constrains the implant215in its insertion position217or257, and transitions from its loaded position502to its unloaded position501thereby delivering the implant215to bone, bones, or bone pieces substantially identical to the implant insertion device100according to the second embodiment as previously set forth in the detailed description thereof. During loading of the implant insertion device500with the implant215and a subsequent retention thereof, the tamp148of the body503sits atop the bridge218of the implant215, while the actuator109progresses along the body503towards the second stop155of the body503until the spacer122of the actuator109at its second end133contacts the second stop155whereby the actuator109extends the first and second blades107and108exterior to the body503such that the first and second blades107and108at their first and second sides115and116respectively abut the engagement points242,247,253, and254of the legs232-234for the implant215, thereby constraining the implant215in its insertion shape217or257. When delivering the implant215to bone, bones, or bone pieces, the actuator109progresses along the body503to the first stop154thereof such that the first and second blades107and108at their first and second sides115and116respectively release the engagement points242,247,253, and254of the legs232-234for the implant215while, if engaged, the first and second blades107and108at their first faces111also release the bridge218, resulting in the discharge of the implant215from the implant grip504and a subsequent attempted transition of the implant215from its insertion shape217or257to its natural shape216whereby the implant215delivers the energy stored therein to the bone, bones, or bone pieces.

FIGS.40A-40Fillustrate a drill guide600according to a first embodiment employed when an implant5according to the first embodiment is delivered to bone, bones, or bone pieces during an orthopedic procedure requiring a drilling of drill holes proximate to fixation devices such as fixation pins or wires (e.g., K-wires). The drill guide600in the first embodiment includes a body601, a template612, and a grip614.

The body601includes a top602, a bottom603, first and second ends604and605, and first and second sides606and607. The body601further includes first, second, third, and fourth passages608-611extending therethrough from its top602to its bottom603. The first and second passages608-609are located adjacent the first end604of the body601, whereas the third and fourth passages610-611are located adjacent the second end605of the body601. The first and third passages608and610are located adjacent the first side606of the body601, whereas the second and fourth passages609and611are located adjacent the second side607of the body601. The first, second, third, and fourth passages608-611accordingly include a configuration complementary in shape with the implant5and, in particular, with the legs23-26thereof whereby the first, second, third, and fourth passages608-611assist in the formation of drill holes that facilitate implantation of the implant5into bone, bones, or bone pieces.

The template612depends from the bottom603of the body601between the first and second passages608-609adjacent the first end604of the body601and the third and fourth passages610-611adjacent the second end605of the body601. The template612includes a slot613that receives therein a fixation device holding bone, bones, or bone pieces during an orthopedic procedure. The slot613divides the template612whereby the first and third passages608and610reside exterior to the slot613at a first side615thereof and the second and fourth passages609and611resides exterior to the slot613at a second side616thereof. As such, when the slot613receives a fixation device therein, the first and third passages608and610are located proximate of the fixation device on one side thereof, whereas the second and fourth passages609and611are located proximate of the fixation device on an opposite side thereof. The template612accordingly through an engagement thereof with the fixation device via its slot613secures the body601on bone, bones, or bone pieces with the first, second, third, and fourth passages608-611proximate to the fixation device whereby drill holes may be formed without contact of the fixation device.

The grip614extends from the body601at its second end605. The grip614facilitates the locating and then the holding of the drill guide600over bone, bones, or bone pieces. Although the grip614facilitates the holding of the drill guide600over bone, bones, or bone pieces, a frictional engagement between the template612and the fixation device at the slot613maintains the body601on the bone, bones, or bone pieces such that the grip614may be released without altering the location of the body601on the bone, bones, or bone pieces.

During an orthopedic procedure, the drill guide600via its grip614situates on bone, bones, or bone pieces with its bottom603adjacent the bone, bones, or bone pieces and its template612introduced at a fusion zone of the bone, bones, or bone pieces such that its slot613receives therein a fixation device inserted into the bone, bones, or bone pieces. The template612via its frictional engagement with the fixation device holds the body601on the bone, bones, or bone pieces and positions the first passage608on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate to a first side of the fixation device, the second passage609on the bone, bones, or bone pieces adjacent the first side of the fusion zone proximate to a second side of the fixation device, the third passage610on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate to the first side of the fixation device, and the fourth passage611on the bone, bones, or bone pieces adjacent the second side of the fusion zone proximate of the second side of the fixation device. With the drill guide600thus situated on the bone, bones, or bone pieces, drill holes formed in the bone, bones, or bone pieces are positioned on both sides of the fusion zone proximate of the fixation device.

In the first embodiment of the drill guide600, the first and second passages608-609and the third and fourth passages610-611are spaced apart a distance substantially equal to the distance between the legs23-24or the legs25-26of the implant5when the implant5resides in its insertion position7or53such that any drill holes formed using the first and second passages608-609or the third and fourth passages610-611will receive the legs23-24or the legs25-26of the implant5therein. Nevertheless, the first and third passages608and610and the second and fourth passages609and611are spaced apart a distance greater than the distance between the legs23and25or the legs24and26of the implant5when the implant5resides in its insertion position7or53on the basis the introduction of the template612into a fusion zone of bone, bones, or bone pieces separates the bone, bones, or bone pieces a distance equal to a thickness617of the template612. In accordance therewith, the distance between the first and third passages608and610and the second and fourth passages609and611in the first embodiment of the drill guide600substantially equals the distance between the legs23and25or the legs24and26of the implant5when the implant5resides in its insertion position7or53plus a distance equal to the thickness617of the template612. As such, any drill holes formed using the first and third passages608and610and the second and fourth passages609and611will receive the legs23and25or the legs24and26of the implant5because, after a removal of the template612and a compression of the bone, bones, or bone pieces at their fusion zone that reduces the separation thereof by the distance equal to the thickness617of the template612, the drill holes reside a distance substantially equal to the distance between the legs23and25or the legs24and26of the implant5when the implant5resides in its insertion position7or53.

FIG.41illustrates a drill guide630according to a second embodiment employed when an implant175according to the second embodiment is delivered to bone, bones, or bone pieces during an orthopedic procedure requiring a drilling of drill holes proximate to fixation devices such as fixation pins or wires (e.g., K-wires). The drill guide630in the second embodiment includes a body631, a template632, and a grip634. The drill guide630according to the second embodiment, including its body631, template642, and grip644, is substantially similar in design and operation relative to the drill guide600according to the first embodiment, including its body601, template612, and grip614. Moreover, although the body631of the drill guide630includes two passages, one of ordinary skill in the art will recognize that any like parts of the drill guide630incorporate a design and function as previously set forth in the detailed description of the drill guide600according to the first embodiment.

The body631includes a top632, a bottom633, first and second ends634and635, and first and second sides636and637. The body631further includes first and second passages638-639extending therethrough from its top632to its bottom633. The first passage638is located adjacent the first end634of the body631, whereas the second passage639is located adjacent the second end635of the body631. The first passage638is located adjacent the second side637of the body631, whereas the second passage639is located adjacent the first side636of the body631, although one of ordinary skill in the art will recognize that the locations of the first and second passages638-639relative to the first and second sides636-637may be reversed. The first and second passages638-639accordingly include a configuration complementary in shape with the implant175and, in particular, with the legs187-188thereof whereby the first and second passages638-639assist in the formation of drill holes that facilitate implantation of the implant175into bone, bones, or bone pieces.

The template642depends from the bottom633of the body631between the first passage638adjacent the first end634of the body631and the second passage639adjacent the second end635of the body631. The template642includes a slot643that receives therein a fixation device holding bone, bones, or bone pieces during an orthopedic procedure. The slot643divides the template642whereby the second passage639resides exterior to the slot643at a first side645thereof and the first passage638resides exterior to the slot643at a second side646thereof. As such, when the slot643receives a fixation device therein, the second passage639is located proximate of the fixation device on one side thereof, whereas the first passage638is located proximate of the fixation device on an opposite side thereof. The template642accordingly through an engagement thereof with the fixation device via its slot613secures the body631on bone, bones, or bone pieces with the first and second passages638-639proximate to the fixation device whereby drill holes may be formed without contact of the fixation device.

The grip644extends from the body631at its second end635. The grip644facilitates the locating and then the holding of the drill guide630over bone, bones, or bone pieces. Although the grip644facilitates the holding of the drill guide630over bone, bones, or bone pieces, a frictional engagement between the template642and the fixation device at the slot643maintains the body631on the bone, bones, or bone pieces such that the grip644may be released without altering the location of the body631on the bone, bones, or bone pieces.

During an orthopedic procedure, the drill guide630via its grip644situates on bone, bones, or bone pieces with its bottom633adjacent the bone, bones, or bone pieces and its template642introduced at a fusion zone of the bone, bones, or bone pieces such that its slot643receives therein a fixation device inserted into the bone, bones, or bone pieces. The template642via its frictional engagement with the fixation device holds the body631on the bone, bones, or bone pieces and positions the first passage638on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate to a first side of the fixation device and the second passage639on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate to a second side of the fixation device. With the drill guide630thus situated on the bone, bones, or bone pieces, drill holes formed in the bone, bones, or bone pieces are positioned on both sides of the fusion zone proximate of the fixation device.

In the second embodiment of the drill guide630, the first and second passages638and639are spaced apart a distance greater than the distance between the legs187and of the implant175when the implant175resides in its insertion position177or207on the basis the introduction of the template642into a fusion zone of bone, bones, or bone pieces separates the bone, bones, or bone pieces a distance equal to a thickness647of the template642. In accordance therewith, the distance between the first and second passages638and639in the second embodiment of the drill guide630substantially equals the distance between the legs187and188of the implant175when the implant175resides in its insertion position177or207plus a distance equal to the thickness647of the template642. As such, any drill holes formed using the first and second passages638and639will receive the legs187and188of the implant175because, after a removal of the template642and a compression of the bone, bones, or bone pieces at their fusion zone that reduces the separation thereof by the distance equal to the thickness647of the template642, the drill holes reside a distance substantially equal to the distance between the legs187and188of the implant175when the implant175resides in its insertion position177or207.

FIG.42illustrates a drill guide650according to a third embodiment employed when an implant215according to the third embodiment is delivered to bone, bones, or bone pieces during an orthopedic procedure requiring a drilling of drill holes proximate to fixation devices such as fixation pins or wires (e.g., K-wires). The drill guide650in the third embodiment includes a body651, a template662, and a grip664. The drill guide650according to the third embodiment, including its body651, template662, and grip664, is substantially similar in design and operation relative to the drill guide600according to the first embodiment, including its body601, template612, and grip614. Moreover, although the body651of the drill guide650includes three passages, one of ordinary skill in the art will recognize that any like parts of the drill guide650incorporate a design and function as previously set forth in the detailed description of the drill guide600according to the first embodiment.

The body651includes a top652, a bottom653, first and second ends654and655, and first and second sides656and657. The body651further includes first, second, and third passages658-660extending therethrough from its top652to its bottom653. The first and second passages658and659are located adjacent the first end654of the body651, whereas the third passage660is located adjacent the second end655of the body651.

The first and third passages658and660are located adjacent the first side656of the body651, whereas the second passage659is located adjacent the second side657of the body651, although one of ordinary skill in the art will recognize that the location of the third passage660may be moved to the second side657. The first, second, and third passages658-660accordingly include a configuration complementary in shape with the implant217and, in particular, with the legs232-234thereof whereby the first, second, and third passages658-660assist in the formation of drill holes that facilitate implantation of the implant217into bone, bones, or bone pieces.

The template662depends from the bottom653of the body651between the first and second passages658-659adjacent the first end654of the body651and the third passage660adjacent the second end655of the body651. The template662includes a slot663that receives therein a fixation device holding bone, bones, or bone pieces during an orthopedic procedure. The slot663divides the template662whereby the first and third passages658and660reside exterior to the slot663at a first side665thereof and the second passage659resides exterior to the slot663at a second side666thereof. As such, when the slot663receives a fixation device therein, the first and third passages658and660are located proximate of the fixation device on one side thereof, whereas the second passage659is located proximate of the fixation device on an opposite side thereof. The template662accordingly through an engagement thereof with the fixation device via its slot663secures the body651on bone, bones, or bone pieces with the first, second, and third passages658-660proximate to a fixation device whereby drill holes may be formed without contact of the fixation device.

The grip664extends from the body651at its second end655. The grip664facilitates the locating and then the holding of the drill guide650over bone, bones, or bone pieces. Although the grip664facilitates the holding of the drill guide650over bone, bones, or bone pieces, a frictional engagement between the template662and the fixation device at the slot663maintains the body651on the bone, bones, or bone pieces such that the grip664may be released without altering the location of the body651on the bone, bones, or bone pieces.

During an orthopedic procedure, the drill guide650via its grip664situates on bone, bones, or bone pieces with its bottom653adjacent the bone, bones, or bone pieces and its template662introduced at a fusion zone of the bone, bones, or bone pieces such that its slot664receives therein a fixation device inserted into the bone, bones, or bone pieces. The template662via its frictional engagement with the fixation device holds the body651on the bone, bones, or bone pieces and positions the first passage658on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate to a first side of the fixation device, the second passage659on the bone, bones, or bone pieces adjacent the first side of the fusion zone proximate to a second side of the fixation device, and the third passage660on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate to the first side of the fixation device. With the drill guide650thus situated on the bone, bones, or bone pieces, drill holes formed in the bone, bones, or bone pieces are positioned on both sides of the fusion zone proximate of the fixation device.

In the third embodiment of the drill guide650, the first and second passages658-659are spaced apart a distance substantially equal to the distance between the legs232-233of the implant215when the implant215resides in its insertion position217or257such that any drill holes formed using the first and second passages658-659will receive the legs232-223of the implant215therein. Nevertheless, the first and second passages658-659are spaced apart from the third passage660a distance greater than the distance between the legs232-233and the leg234of the implant215when the implant215resides in its insertion position217or257on the basis the introduction of the template662into a fusion zone of bone, bones, or bone pieces separates the bone, bones, or bone pieces a distance equal to a thickness667of the template662. In accordance therewith, the distance between the first and second passages658-659and the third passage660in the third embodiment of the drill guide650substantially equals the distance between the legs232-233and the legs234of the implant215when the implant215resides in its insertion position217or257plus a distance equal to the thickness667of the template662. As such, any drill holes formed using the first and second passages658-659and the third passage660will receive the legs232-233and the legs234of the implant215because, after a removal of the template662and a compression of the bone, bones, or bone pieces at their fusion zone that reduces the separation thereof by the distance equal to the thickness667of the template662, the drill holes reside a distance substantially equal to the distance between the legs232-233and the legs234of the implant215when the implant215resides in its insertion position217or257.

FIGS.43A-43Fillustrate a drill guide900according to a fourth embodiment employed when an implant5according to the first embodiment is delivered to bone, bones, or bone pieces during an orthopedic procedure requiring a drilling of drill holes proximate to fixation devices such as fixation pins or wires (e.g., K-wires). The drill guide900in the fourth embodiment includes a body901, first and second templates912and922, and first and second grips914and924.

The body901includes a top902, a bottom903, first and second ends904and905, and first and second sides906and907. The body901further includes first, second, third, and fourth passages908-911extending therethrough from its top902to its bottom903. The first and second passages908-909are located adjacent the first end904of the body901, whereas the third and fourth passages910-911are located adjacent the second end905of the body901. The first and third passages908and910are located adjacent the first side906of the body901, whereas the second and fourth passages909and911are located adjacent the second side907of the body901. The first, second, third, and fourth passages908-911accordingly include a configuration complementary in shape with the implant5and, in particular, with the legs23-26thereof whereby the first, second, third, and fourth passages908-911assist in the formation of drill holes that facilitate implantation of the implant5into bone, bones, or bone pieces.

The first grip914extends from the body901at its first end904. Similarly, the second grip924extends from the body901at its second end905. The first and second grips914and924facilitate the locating and then the holding of the drill guide900over bone, bones, or bone pieces.

The first template912depends from the first grip914in a position opposite to the first end904and beneath the bottom903of the body901. The second template922depends from the second grip924in a position opposite to the second end905and beneath the bottom903of the body901. The first and second templates912and922respectively include slots913and923that receive therein a fixation device holding bone, bones, or bone pieces during an orthopedic procedure. The slots913and923divide respectively the first and second templates912and922whereby the first and third passages908and910reside exterior to the slots913and923at first sides915and925thereof and the second and fourth passages909and911resides exterior to the slots913and923at second sides916and926thereof. As such, when the slots913and923receive a fixation device therein, the first and third passages908and910are located proximate of the fixation device on one side thereof, whereas the second and fourth passages909and911are located proximate of the fixation device on an opposite side thereof. The first and second templates912and922accordingly through an engagement thereof with the fixation device via respective slots913and923secure the body901on bone, bones, or bone pieces with the first, second, third, and fourth passages908-911proximate to the fixation device whereby drill holes may be formed without contact of the fixation device. While the first and second grips914and922facilitate the holding of the drill guide900over bone, bones, or bone pieces, a frictional engagement between the first and second templates912and922and the fixation device at the slots913and923maintains the body901on the bone, bones, or bone pieces such that the first and second grips914and922may be released without altering the location of the body901on the bone, bones, or bone pieces.

During an orthopedic procedure, the drill guide900via its first and second grips914and924situates on bone, bones, or bone pieces at a fusion zone thereof with its bottom903adjacent the bone, bones, or bone pieces and its first and second templates912and922located at opposite sides of the bone, bones, or bone pieces such that its slots913and923receive therein a fixation device inserted into the bone, bones, or bone pieces. The first and second templates912and922via their frictional engagement with the fixation device holds the body901on the bone, bones, or bone pieces and positions the first passage908on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate to a first side of the fixation device, the second passage909on the bone, bones, or bone pieces adjacent the first side of the fusion zone proximate to a second side of the fixation device, the third passage910on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate to the first side of the fixation device, and the fourth passage911on the bone, bones, or bone pieces adjacent the second side of the fusion zone proximate of the second side of the fixation device. With the drill guide900thus situated on the bone, bones, or bone pieces, drill holes formed in the bone, bones, or bone pieces are positioned on both sides of the fusion zone proximate of the fixation device.

In the fourth embodiment of the drill guide900, the first and second passages908-909and the third and fourth passages910-911are spaced apart a distance substantially equal to the distance between the legs23-24or the legs25-26of the implant5when the implant5resides in its insertion position7or53such that any drill holes formed using the first and second passages908-909or the third and fourth passages910-911will receive the legs23-24or the legs25-26of the implant5therein. Likewise, the first and third passages908and910and the second and fourth passages909and911are spaced apart a distance substantially equal to the distance between the legs23and25or the legs24and26of the implant5when the implant5resides in its insertion position7or53such that any drill holes formed using the first and third passages908and910or the second and fourth passages909and911will receive the legs23and25or the legs24and26of the implant5therein.

FIG.44illustrates a drill guide930according to a fifth embodiment employed when an implant175according to the second embodiment is delivered to bone, bones, or bone pieces during an orthopedic procedure requiring a drilling of drill holes proximate to fixation devices such as fixation pins or wires (e.g., K-wires). The drill guide930in the fifth embodiment includes a body931, first and second templates940and942, and first and second grips944and945. The drill guide930according to the fifth embodiment, including its body931, first and second templates940and942, and first and second grips944and945, is substantially similar in design and operation relative to the drill guide900according to the fourth embodiment, including its body901, first and second templates912and922, and first and second grips914and924. Moreover, although the body931of the drill guide930includes two passages, one of ordinary skill in the art will recognize that any like parts of the drill guide930incorporate a design and function as previously set forth in the detailed description of the drill guide900according to the fourth embodiment.

The body931includes a top932, a bottom933, first and second ends934and935, and first and second sides936and937. The body931further includes first and second passages938-939extending therethrough from its top932to its bottom933. The first passage938is located adjacent the first end934of the body931, whereas the second passage939is located adjacent the second end935of the body931. The first passage938is located adjacent the second side937of the body931, whereas the second passage939is located adjacent the first side936of the body931, although one of ordinary skill in the art will recognize that the locations of the first and second passages938-939relative to the first and second sides936-937may be reversed. The first and second passages938-939accordingly include a configuration complementary in shape with the implant175and, in particular, with the legs187-188thereof whereby the first and second passages938-939assist in the formation of drill holes that facilitate implantation of the implant175into bone, bones, or bone pieces.

The first grip944extends from the body931at its first end934. Similarly, the second grip945extends from the body931at its second end935. The first and second grips944and945facilitate the locating and then the holding of the drill guide930over bone, bones, or bone pieces.

The first template940depends from the first grip944in a position opposite to the first end934and beneath the bottom933of the body931. The second template942depends from the second grip945in a position opposite to the second end935and beneath the bottom933of the body931. The first and second templates940and942respectively include slots941and943that receive therein a fixation device holding bone, bones, or bone pieces during an orthopedic procedure. The slots941and943divide respectively the first and second templates940and942whereby the second passage639resides exterior to the slots941and943at first sides946and948thereof and the first passage638resides exterior to the slots941and943at second sides947and949thereof. As such, when the slots941and943receive a fixation device therein, the second passage639is located proximate of the fixation device on one side thereof, whereas the first passage638is located proximate of the fixation device on an opposite side thereof. The first and second templates940and942accordingly through an engagement thereof with the fixation device via respective slots941and943secure the body931on bone, bones, or bone pieces with the first and second passages638-639proximate to the fixation device whereby drill holes may be formed without contact of the fixation device. While the first and second grips944and945facilitate the holding of the drill guide930over bone, bones, or bone pieces, a frictional engagement between the first and second templates940and942and the fixation device at the slots941and943maintains the body931on the bone, bones, or bone pieces such that the first and second grips944and945may be released without altering the location of the body931on the bone, bones, or bone pieces.

During an orthopedic procedure, the drill guide930via its first and second grips944and945situates on bone, bones, or bone pieces at a fusion zone thereof with its bottom933adjacent the bone, bones, or bone pieces and its first and second templates940and942located at opposite sides of the bone, bones, or bone pieces such that its slots941and943receive therein a fixation device inserted into the bone, bones, or bone pieces. The first and second templates940and942via their frictional engagement with the fixation device holds the body931on the bone, bones, or bone pieces and positions the first passage938on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate to a first side of the fixation device and the second passage939on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate to a second side of the fixation device. With the drill guide930thus situated on the bone, bones, or bone pieces, drill holes formed in the bone, bones, or bone pieces are positioned on both sides of the fusion zone proximate of the fixation device. In the fifth embodiment of the drill guide930, the first and second passages938and939are spaced apart a distance substantially equal to the distance between the legs187and188of the implant175when the implant175resides in its insertion position177or207such that any drill holes formed using the first and second passages938and939will receive the legs187and188of the implant175therein.

FIG.45illustrates a drill guide950according to a sixth embodiment employed when an implant215according to the third embodiment is delivered to bone, bones, or bone pieces during an orthopedic procedure requiring a drilling of drill holes proximate to fixation devices such as fixation pins or wires (e.g., K-wires). The drill guide950in the fifth embodiment includes a body951, first and second templates961and963, and first and second grips965and966. The drill guide950according to the sixth embodiment, including its body951, first and second templates961and963, and first and second grips965and966, is substantially similar in design and operation relative to the drill guide900according to the fourth embodiment, including its body901, first and second templates912and922, and first and second grips914and924. Moreover, although the body931of the drill guide930includes three passages, one of ordinary skill in the art will recognize that any like parts of the drill guide950incorporate a design and function as previously set forth in the detailed description of the drill guide900according to the fourth embodiment.

The body951includes a top952, a bottom953, first and second ends954and955, and first and second sides956and957. The body951further includes first, second, and third passages958-960extending therethrough from its top952to its bottom953. The first and second passages958and959are located adjacent the first end954of the body951, whereas the third passage960is located adjacent the second end955of the body951. The first and third passages958and960are located adjacent the first side956of the body951, whereas the second passage959is located adjacent the second side957of the body951, although one of ordinary skill in the art will recognize that the location of the third passage960may be moved to the second side957. The first, second, and third passages958-960accordingly include a configuration complementary in shape with the implant217and, in particular, with the legs232-234thereof whereby the first, second, and third passages958-960assist in the formation of drill holes that facilitate implantation of the implant217into bone, bones, or bone pieces.

The first grip965extends from the body951at its first end954. Similarly, the second grip966extends from the body951at its second end955. The first and second grips965and966facilitate the locating and then the holding of the drill guide950over bone, bones, or bone pieces.

The first template961depends from the first grip965in a position opposite to the first end954and beneath the bottom953of the body951. The second template963depends from the second grip966in a position opposite to the second end955and beneath the bottom953of the body951. The first and second templates961and963respectively include slots962and964that receive therein a fixation device holding bone, bones, or bone pieces during an orthopedic procedure. The slots962and964divide respectively the first and second templates961and963whereby the first and third passages958and960reside exterior to the slots962and964at first sides967and969thereof and the second passage959resides exterior to the slots962and964at second sides968and970thereof. As such, when the slots962and964receive a fixation device therein, the first and third passages658and660are located proximate of the fixation device on one side thereof, whereas the second passage659is located proximate of the fixation device on an opposite side thereof. The first and second templates961and963accordingly through an engagement thereof with the fixation device via respective slots962and964secure the body951on bone, bones, or bone pieces with the first, second, and third passages958-660proximate to a fixation device whereby drill holes may be formed without contact of the fixation device. While the first and second grips965and966facilitate the holding of the drill guide950over bone, bones, or bone pieces, a frictional engagement between the first and second templates961and963and the fixation device at the slots961and964maintains the body951on the bone, bones, or bone pieces such that the first and second grips965and966may be released without altering the location of the body951on the bone, bones, or bone pieces.

During an orthopedic procedure, the drill guide950via its first and second grips965and966situates on bone, bones, or bone pieces at a fusion zone thereof with its bottom953adjacent the bone, bones, or bone pieces and its first and second templates961and963located at opposite sides of the bone, bones, or bone pieces such that its slots962and964receive therein a fixation device inserted into the bone, bones, or bone pieces. The first and second templates961and963via their frictional engagement with the fixation device holds the body951on the bone, bones, or bone pieces and positions the first passage958on the bone, bones, or bone pieces adjacent a first side of the fusion zone proximate to a first side of the fixation device, the second passage659on the bone, bones, or bone pieces adjacent the first side of the fusion zone proximate to a second side of the fixation device, and the third passage660on the bone, bones, or bone pieces adjacent a second side of the fusion zone proximate to the first side of the fixation device. With the drill guide950thus situated on the bone, bones, or bone pieces, drill holes formed in the bone, bones, or bone pieces are positioned on both sides of the fusion zone proximate of the fixation device.

In the sixth embodiment of the drill guide950, the first and second passages658-659are spaced apart a distance substantially equal to the distance between the legs232-233of the implant215when the implant215resides in its insertion position217or257such that any drill holes formed using the first and second passages658-659will receive the legs232-223of the implant215therein. Likewise, the first and second passages958and959are spaced apart from the third passage960a distance substantially equal to the distance between the legs232-233and the leg234of the implant215when the implant215resides in its insertion position217or257such that any drill holes formed using the first, second, and third passages958-960will receive the legs232-234of the implant215therein.

FIG.46illustrates the implant insertion device60with the implant5of the first embodiment loaded thereon in an orthopedic fixation system whereby the implant insertion device60retains the implant5in its insertion shape7or53such that the implant5is ready for implantation into bone, bones, or bone pieces, and, in particular, into a first bone701and a second bone702, which are presented herein as an example. A surgeon as illustrated inFIG.46aligns the first bone701with the second bone702at a fusion zone703in an orientation that promotes fixation of the first bone701with the second bone702and a proper healing thereof. The surgeon then drills first and second holes704and705in the first bone701and third and fourth holes706and707in the second bone702. The first, second, third, and fourth holes704-707are drilled at spacings and locations desired for insertion of the legs23and24into the first bone701and the legs25and26into the second bone702with the bridge8spanning the fusion zone703when the implant5resides in its insertion shape7or53. While not required, the surgeon may create grooves in the first and second bones701and702that facilitate a more flush seating of the bridge8for the implant5relative to the first and second bones701and702. The surgeon next utilizes the implant insertion device60to position the tip27of the leg23for the implant5adjacent the pre-drilled hole704, the tip28of the leg24for the implant5adjacent the pre-drilled hole705, the tip29of the leg25for the implant5adjacent the pre-drilled hole706, and the tip30of the leg26for the implant5adjacent the pre-drilled hole707.

The surgeon as illustrated inFIG.47maneuvers the implant insertion device60using its body63such that the legs23-26respectively enter the pre-drilled holes704-707. The surgeon further manipulates the implant insertion device60to insert the legs23-26respectively into the pre-drilled holes704-707until the implant grip64resides on the first and second bones701and702. More particularly, the surgeon pushes on the body63resulting in the tamp79of the body63via its contact with the bridge8of the implant5pushing on the bridge8, which, in turn, transfers the pushing force to the legs23-26and respectively inserts the legs23-26into the pre-drilled holes704-707until the lower surface90of the shell67for the implant grip64abuts the first and second bones701and702exterior of the first, second, third, and fourth holes704-707.

The surgeon as illustrated inFIG.48continues manipulating the implant insertion device60to insert the legs23-26, via the tamp79and its transfer of the pushing force to the legs23-26, until the implant5at its bridge8resides adjacent the first and second bones701and702across the fusion zone703thereof, and, in particular, until the bridge8abuts the first and second bones701and702. The surgeon concurrently progresses the implant grip64from its engaged position66to its disengaged position65, thereby releasing the implant5from the implant insertion device60. Progression of the implant grip64from its engaged position66to its disengaged position65involves the pushing force also being applied to the implant grip64due to the contact thereof with the first and second bones701and702at the lower surface90of its shell67. The shell67accordingly moves along the implant grip receiver78of the body63until the shell67at its upper surface89abuts the stop84adjacent the implant grip receiver78, resulting in the detents88and89disengaging from the notches92and respectively sliding into the notches91thereby locking the implant grip64in its disengaged position65. If desired, progression of the implant grip64from its engaged position66to its disengaged position65may include the surgeon pulling on the implant grip64while inserting the legs23-26respectively into the first and second bones701and702.

The tamp79of the implant grip receiver78for the body63remains atop the bridge8of the implant5to prevent movement of the implant5relative to the implant grip64during progression of the implant grip64from its engaged position66to its disengaged position65. As a consequence, the projections83-86of the interior surface69, when the implant grip64moves from its engaged position66to its disengaged position65, by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereby releasing a respective leg23-26opposite from the segments34,39,44, and49. The projections83-86insert into the indentations93and94in the implant grip receiver78to prevent the projections83-86from impeding movement of the implant grip64relative to the implant grip receiver78such that the tamp79ultimately reaches a position adjacent the lower surface90of the shell67. Similarly, the retention surfaces79-82disposed in each of the grooves71-74respectively release an engagement point35,40,44, and50of the legs23-26, while the grooves71-74of the interior surface69for the shell67respectively disengage from a segment34,39,44, and49of the legs23-26. Moreover, the interior surface69of the shell67disengages from the first and second sides11and12of the bridge8at their concave sections11aand12a, whereas the interior surface69of the shell67further by-passes the bridge8of the implant5at its first and second sides11and12and its first and second ends13and14such that the implant5exits the passage70of the shell67, resulting in the discharge of the implant5from the implant grip64. While an insertion of the implant5typically includes pre-drilling of the first, second, third, and fourth holes704-707, the surgeon may use the implant insertion device60to impact the legs23-26respectively into the first and second bones701and702at a desired location.

Once the surgeon implants the implant5into the first and second bones701and702with its bridge8spanning the fusion zone703using the implant insertion device60, including the implant insertion device60traversing to its unloaded position61, whereby the implant grip64in its disengaged position65releases the implant5, the surgeon as illustrated inFIG.49removes the implant insertion device60from the implant5, which includes removal of the shell67away from the implant5and the tamp79from atop the bridge8. The implant5, due to its superelastic or temperature dependent properties, delivers the energy stored in the transition sections15-18and/or the transition section51such that the bridge8attempts to transition from its insertion form to its natural form, resulting in the legs23-26attempting to move from their insertion position to their natural position, whereby the implant5affixes the first bone701and the second bone702through an application of a compressive force to the fixation zone703.

The implant insertion device60accordingly improves insertion of the implant5because the implant insertion device60does not release its constraint of the implant5until the legs23-26of the implant5fully insert respectively into the first, second, third, and fourth holes704-707of the first and second bones701and702and the bridge8of the implant5completely seats flush atop the first and second bones701and702. As such, the implant insertion device60eliminates an extra tamping step that may not practical or possible, may cause damage to the implant5, or may cause a failure in the first and second bones701and702. Moreover, the implant insertion device60prevents the implant5from prematurely delivering the energy stored therein to the first and second bones701and702at the fixation zone703thereof.

When implanting the implant5into the first and second bones701and702utilizing the implant insertion device100, one of ordinary skill in the art will recognize that the implant insertion device100operates substantially similar with respect to the implantation of the implant5using the implant insertion device60as previously described except that the implant grip104for the implant insertion device100, which includes the actuator109and the first and second blades107and108that contact the first and second bones701and702, facilitates delivery of the implant5to first and second bones701and702. Alternatively, when implanting the implant175utilizing the implant insertion device208or the implant215utilizing the implant insertion device400, one of ordinary skill in the art will recognize that the implant insertion devices208or400operate substantially similar with respect to the implantation of the implant5using the implant insertion device60as previously described except that the number of pre-drilled holes will correspond in location, spacing, and number based upon the configuration and number of legs for the implants175and215. Moreover, when implanting the implant175utilizing the implant insertion device300or the implant215utilizing the implant insertion device500, one of ordinary skill in the art will recognize that the implant insertion devices300and500operate substantially similar with respect to the implantation of the implant5using the implant insertion device60as previously described except that the implant grips304and504for the implant insertion devices300and500, which include respectively the actuators109and the first and second blades107and108that contact the first and second bones701and702, facilitate delivery of the implant175or215to first and second bones701and702and that the number of pre-drilled holes will correspond in location, spacing, and number based upon the configuration and number of legs for the implants175and215.

FIGS.50A-54illustrate use of the drill guide600according to the first embodiment in combination with an orthopedic fixation system that implants an implant into bone, bones, or bone pieces, and, in particular, into a first bone801and a second bone802, which are presented herein as an example. WhileFIGS.50A-54illustrate the drill guide600used with an implant insertion device60retaining an implant5in its insertion shape7or53, one of ordinary skill in the art will recognize that the drill guide600may be used with any four-legged implant and alternative techniques or implant insertion devices.

A surgeon as illustrated inFIGS.50A-50Baligns the first bone801with the second bone802at a fusion zone803in an orientation that promotes fixation of the first bone801with the second bone802and a proper healing thereof. After aligning the first bone801with the second bone802at the fusion zone803thereof, the surgeon introduces a fixation device into the first bone801and the second bone802. Illustratively, the surgeon inserts a K-wire810through the first bone801and into the second bone802whereby the K-wire810spans the fixation zone803and secures the first bone801with the second bone802in the orientation that promotes the proper healing thereof. The surgeon then situates the drill guide600on the first bone801and the second bone802across the fusion zone803. More particularly, the surgeon using the grip614of the drill guide600places the body601of the drill guide600on the first bone801and the second bone802across the fusion zone803with its bottom603abutting the first and second bones801and802and inserts the template612of the drill guide600into the fusion zone803between the first bone801and the second bone802such that the slot613of the template612receives therein the K-wire810. The template612via its insertion into the fusion zone803and engagement with the K-wire810secures the body601of the drill guide600on the first and second bones801and802and positions the third passage610of the body601on the first bone801adjacent a first side804of the fusion zone803proximate to a first side811of the K-wire810, the fourth passage611on the first bone801adjacent the first side804of the fusion zone803proximate to a second side812of the K-wire810, the first passage608on the second bone802adjacent a second side805of the fusion zone803proximate to the first side811of the K-wire810, and the second passage609on the second bone802adjacent the second side805of the fusion zone803proximate to the second side812of the K-wire810.

With the body601of the drill guide600thus situated on the first and second bones801and802including the template612of the drill guide600inserted between the first bone801and the second bone802and engaged with the K-wire810, the surgeon drills a first hole806in the first bone801adjacent the first side804of the fusion zone803proximate to the first side811of the K-wire810, a second hole807in the first bone801adjacent the first side804of the fusion zone803proximate to the second side812of the K-wire810, a third hole808in the second bone802adjacent the second side805of the fusion zone803proximate to the first side811of the K-wire810, and a fourth hole809in the second bone802adjacent the second side805of the fusion zone803proximate of the second side812of the K-wire810. The drill guide600accordingly facilitates the drilling of the first, second, third, and fourth drill holes806-809in close proximity to the K-wire810while preventing a drill bit of a drill used in forming the first, second, third, and fourth drill holes806-809from striking the K-wire810. Although the insertion of the template613into the fusion zone803separates the first bone801from the second bone802, the first bone801remains aligned with the second bone802in the orientation that promotes their fixation and proper healing due to the insertion of the K-wire810into the first and second bones801and802spanning the fusion zone803and its engagement with the template613via the slot613thereof.

After drilling the first, second, third, and fourth drill holes806-809, the surgeon as illustrated inFIG.51removes the drill guide600from the first and second bones801and802whereby the template612disengages from the K-wire810and exits the fusion zone803. The surgeon then compresses the first bone801and the second bone802until the first and second bones801and802abut at their fusion zone803. While the compression of the first and second bones801and802reduces the distance between the first and third holes806and808and the second and fourth holes807and809relative to the distance between the first and third passages608and610and the second and fourth passages609and611, that reduction in distance does not affect the ability of the first and third holes806and808and the second and fourth holes807and809to respectively receive therein the legs23and25or the legs24and26of the implant5when the implant5resides in its insertion position7or53because the distance between the first and third passages608and610and the second and fourth passages609and611in the first embodiment of the drill guide600substantially equals the distance between the legs23and25or the legs24and26of the implant5when the implant5resides in its insertion position7or53plus the distance equal to the thickness617of the template612.

Once any necessary re-orientation of the first and second bones801and802is performed, the surgeon is ready for implantation of the implant5in its insertion shape7or53into the first and second bones801and802using the implant insertion device60. The first, second, third, and fourth holes806-809as previously described reside respectively in the first and second bones801and802at spacings and locations desired for insertion of the legs23and24into the first bone801and the legs25and26into the second bone802with the bridge8spanning the fusion zone803when the implant5resides in its insertion shape7or53. While not required, the surgeon may create grooves in the first and second bones801and802that facilitate a more flush seating of the bridge8for the implant5relative to the first and second bones801and802. The surgeon next utilizes the implant insertion device60to position the tip27of the leg23for the implant5adjacent the pre-drilled hole806, the tip28of the leg24for the implant5adjacent the pre-drilled hole807, the tip29of the leg25for the implant5adjacent the pre-drilled hole808, and the tip30of the leg26for the implant5adjacent the pre-drilled hole809.

The surgeon as illustrated inFIG.52maneuvers the implant insertion device60using its body63such that the legs23-26respectively enter the pre-drilled holes806-809. The surgeon further manipulates the implant insertion device60to insert the legs23-26respectively into the pre-drilled holes806-809until the implant grip64resides on the first and second bones801and802. More particularly, the surgeon pushes on the body63resulting in the tamp79of the body63via its contact with the bridge8of the implant5pushing on the bridge8, which, in turn, transfers the pushing force to the legs23-26and respectively inserts the legs23-26into the pre-drilled holes806-809until the lower surface90of the shell67for the implant grip64abuts the first and second bones801and802exterior of the first, second, third, and fourth holes806-809.

The surgeon as illustrated inFIG.53continues manipulating the implant insertion device60to insert the legs23-26, via the tamp79and its transfer of the pushing force to the legs23-26, until the implant5at its bridge8resides adjacent the first and second bones801and802across the fusion zone803thereof, and, in particular, until the bridge8abuts the first and second bones801and802. The surgeon concurrently progresses the implant grip64from its engaged position66to its disengaged position65, thereby releasing the implant5from the implant insertion device60. Progression of the implant grip64from its engaged position66to its disengaged position65involves the pushing force also being applied to the implant grip64due to the contact thereof with the first and second bones801and802at the lower surface90of its shell67. The shell67accordingly moves along the implant grip receiver78of the body63until the shell67at its upper surface89abuts the stop84adjacent the implant grip receiver78, resulting in the detents88and89disengaging from the notches92and respectively sliding into the notches91thereby locking the implant grip64in its disengaged position65. If desired, progression of the implant grip64from its engaged position66to its disengaged position65may include the surgeon pulling on the implant grip64while inserting the legs23-26respectively into the first and second bones801and802.

The tamp79of the implant grip receiver78for the body63remains atop the bridge8of the implant5to prevent movement of the implant5relative to the implant grip64during progression of the implant grip64from its engaged position66to its disengaged position65. As a consequence, the projections83-86of the interior surface69, when the implant grip64moves from its engaged position66to its disengaged position65, by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereby releasing a respective leg23-26opposite from the segments34,39,44, and49. The projections83-86insert into the indentations93and94in the implant grip receiver78to prevent the projections83-86from impeding movement of the implant grip64relative to the implant grip receiver78such that the tamp79ultimately reaches a position adjacent the lower surface90of the shell67. Similarly, the retention surfaces79-82disposed in each of the grooves71-74respectively release an engagement point35,40,44, and50of the legs23-26, while the grooves71-74of the interior surface69for the shell67respectively disengage from a segment34,39,44, and49of the legs23-26. Moreover, the interior surface69of the shell67disengages from the first and second sides11and12of the bridge8at their concave sections11aand12a, whereas the interior surface69of the shell67further by-passes the bridge8of the implant5at its first and second sides11and12and its first and second ends13and14such that the implant5exits the passage70of the shell67, resulting in the discharge of the implant5from the implant grip64.

Once the surgeon implants the implant5into the first and second bones801and802with its bridge8spanning the fusion zone803using the implant insertion device60, including the implant insertion device60traversing to its unloaded position61, whereby the implant grip64in its disengaged position65releases the implant5, the surgeon as illustrated inFIG.54removes the implant insertion device60from the implant5, which includes removal of the shell67away from the implant5and the tamp79from atop the bridge8. The implant5, due to its superelastic or temperature dependent properties, delivers the energy stored in the transition sections15-18and/or the transition section51such that the bridge8attempts to transition from its insertion form to its natural form, resulting in the legs23-26attempting to move from their insertion position to their natural position, whereby the implant5affixes the first bone801and the second bone802through an application of a compressive force to the fixation zone803. The surgeon finally, if desired, removes the K-wire810from the first and second bones801and802.

When implanting a two-legged implant such as the implant175utilizing an orthopedic procedure incorporating the drill guide630or a three-legged implant such as the implant215utilizing an orthopedic procedure incorporating the drill guide650, one of ordinary skill in the art will recognize that orthopedic procedures incorporating the drill guides630and650will be substantially similar with respect to the orthopedic procedure incorporating the drill guide600as previously described except that the number of pre-drilled holes will correspond in location, spacing, and number based upon the configurations for the drill guides630and650.

FIGS.55A-59illustrate use of the drill guide900according to the fourth embodiment in combination with an orthopedic fixation system that implants an implant into bone, bones, or bone pieces, and, in particular, into a first bone851and a second bone852, which are presented herein as an example. WhileFIGS.55A-59illustrate the drill guide900used with an implant insertion device60retaining an implant5in its insertion shape7or53, one of ordinary skill in the art will recognize that the drill guide900may be used with any four-legged implant and alternative techniques or implant insertion devices.

A surgeon as illustrated inFIGS.55A-55Baligns the first bone851with the second bone852at a fusion zone853in an orientation that promotes fixation of the first bone851with the second bone852and a proper healing thereof. After aligning the first bone851with the second bone852at the fusion zone853thereof, the surgeon introduces a fixation device into the first bone851and the second bone852. Illustratively, the surgeon inserts a K-wire860through the first bone and second bone851and852whereby the K-wire860spans the fixation zone853and secures the first bone851with the second bone852in the orientation that promotes the proper healing thereof. The surgeon then situates the drill guide900on the first bone851and the second bone852across the fusion zone853. More particularly, the surgeon using the first and/or second grips914and924of the drill guide900places the body901of the drill guide900on the first bone851and the second bone852across the fusion zone853with its bottom903abutting the first and second bones851and852. The surgeon further positions the first template912of the drill guide900adjacent the first bone851such that its slot913receives therein the K-wire860extending from the first bone851and the second template922of the drill guide900adjacent the second bone852such that its slot923receives therein the K-wire860extending from the second bone851. The first and second templates912and922via their positioning respectively adjacent the first and second bones851and852and engagement with the K-wire860secure the body901of the drill guide900on the first and second bones851and852and positions the first passage908of the body901on the first bone851adjacent a first side854of the fusion zone853proximate to a first side861of the K-wire860, the second passage909on the first bone851adjacent the first side854of the fusion zone853proximate to a second side862of the K-wire860, the third passage910on the second bone852adjacent a second side855of the fusion zone853proximate to the first side861of the K-wire860, and the fourth passage911on the second bone852adjacent the second side855of the fusion zone853proximate to the second side862of the K-wire860.

With the body901of the drill guide900thus situated on the first and second bones851and852including the first and second templates912and922of the drill guide900positioned respectively adjacent the first and second bones851and852and engaged with the K-wire860, the surgeon drills a first hole856in the first bone851adjacent the first side854of the fusion zone853proximate to the first side861of the K-wire860, a second hole857in the first bone851adjacent the first side854of the fusion zone853proximate to the second side862of the K-wire860, a third hole858in the second bone852adjacent the second side855of the fusion zone853proximate to the first side861of the K-wire860, and a fourth hole859in the second bone852adjacent the second side855of the fusion zone853proximate of the second side862of the K-wire860. The drill guide900accordingly facilitates the drilling of the first, second, third, and fourth drill holes866-859in close proximity to the K-wire860while preventing a drill bit of a drill used in forming the first, second, third, and fourth drill holes856-859from striking the K-wire860. After drilling the first, second, third, and fourth drill holes856-859, the surgeon as illustrated inFIG.56removes the drill guide900from the first and second bones851and852whereby the first and second templates912and922disengage from the K-wire860.

Once any necessary re-orientation of the first and second bones851and852is performed, the surgeon is ready for implantation of the implant5in its insertion shape7or53into the first and second bones851and852using the implant insertion device60. The first, second, third, and fourth holes856-859, based upon the locations of the first, second, third, and fourth passages908-911of the body901as previously described, reside respectively in the first and second bones851and852at spacings and locations desired for insertion of the legs23and24into the first bone851and the legs25and26into the second bone852with the bridge8spanning the fusion zone853when the implant5resides in its insertion shape7or53. While not required, the surgeon may create grooves in the first and second bones851and852that facilitate a more flush seating of the bridge8for the implant5relative to the first and second bones851and852. The surgeon next utilizes the implant insertion device60to position the tip27of the leg23for the implant5adjacent the pre-drilled hole856, the tip28of the leg24for the implant5adjacent the pre-drilled hole857, the tip29of the leg25for the implant5adjacent the pre-drilled hole858, and the tip30of the leg26for the implant5adjacent the pre-drilled hole859.

The surgeon as illustrated inFIG.57maneuvers the implant insertion device60using its body63such that the legs23-26respectively enter the pre-drilled holes856-859. The surgeon further manipulates the implant insertion device60to insert the legs23-26respectively into the pre-drilled holes856-859until the implant grip64resides on the first and second bones851and852. More particularly, the surgeon pushes on the body63resulting in the tamp79of the body63via its contact with the bridge8of the implant5pushing on the bridge8, which, in turn, transfers the pushing force to the legs23-26and respectively inserts the legs23-26into the pre-drilled holes856-859until the lower surface90of the shell67for the implant grip64abuts the first and second bones851and852exterior of the first, second, third, and fourth holes856-859.

The surgeon as illustrated inFIG.58continues manipulating the implant insertion device60to insert the legs23-26, via the tamp79and its transfer of the pushing force to the legs23-26, until the implant5at its bridge8resides adjacent the first and second bones851and852across the fusion zone853thereof, and, in particular, until the bridge8abuts the first and second bones851and852. The surgeon concurrently progresses the implant grip64from its engaged position66to its disengaged position65, thereby releasing the implant5from the implant insertion device60. Progression of the implant grip64from its engaged position66to its disengaged position65involves the pushing force also being applied to the implant grip64due to the contact thereof with the first and second bones851and852at the lower surface90of its shell67. The shell67accordingly moves along the implant grip receiver78of the body63until the shell67at its upper surface89abuts the stop84adjacent the implant grip receiver78, resulting in the detents88and89disengaging from the notches92and respectively sliding into the notches91thereby locking the implant grip64in its disengaged position65. If desired, progression of the implant grip64from its engaged position66to its disengaged position65may include the surgeon pulling on the implant grip64while inserting the legs23-26respectively into the first and second bones851and852.

The tamp79of the implant grip receiver78for the body63remains atop the bridge8of the implant5to prevent movement of the implant5relative to the implant grip64during progression of the implant grip64from its engaged position66to its disengaged position65. As a consequence, the projections83-86of the interior surface69, when the implant grip64moves from its engaged position66to its disengaged position65, by-pass respectively the bridge8at its first and second ends13and14via the concave sections13aand14athereby releasing a respective leg23-26opposite from the segments34,39,44, and49. The projections83-86insert into the indentations93and94in the implant grip receiver78to prevent the projections83-86from impeding movement of the implant grip64relative to the implant grip receiver78such that the tamp79ultimately reaches a position adjacent the lower surface90of the shell67. Similarly, the retention surfaces79-82disposed in each of the grooves71-74respectively release an engagement point35,40,44, and50of the legs23-26, while the grooves71-74of the interior surface69for the shell67respectively disengage from a segment34,39,44, and49of the legs23-26. Moreover, the interior surface69of the shell67disengages from the first and second sides11and12of the bridge8at their concave sections11aand12a, whereas the interior surface69of the shell67further by-passes the bridge8of the implant5at its first and second sides11and12and its first and second ends13and14such that the implant5exits the passage70of the shell67, resulting in the discharge of the implant5from the implant grip64.

Once the surgeon implants the implant5into the first and second bones851and852with its bridge8spanning the fusion zone853using the implant insertion device60, including the implant insertion device60traversing to its unloaded position61, whereby the implant grip64in its disengaged position65releases the implant5, the surgeon as illustrated inFIG.59removes the implant insertion device60from the implant5, which includes removal of the shell67away from the implant5and the tamp79from atop the bridge8. The implant5, due to its superelastic or temperature dependent properties, delivers the energy stored in the transition sections15-18and/or the transition section51such that the bridge8attempts to transition from its insertion form to its natural form, resulting in the legs23-26attempting to move from their insertion position to their natural position, whereby the implant5affixes the first bone851and the second bone852through an application of a compressive force to the fixation zone853. The surgeon finally, if desired, removes the K-wire860from the first and second bones851and852.

When implanting a two-legged implant such as the implant175utilizing an orthopedic procedure incorporating the drill guide930or a three-legged implant such as the implant215utilizing an orthopedic procedure incorporating the drill guide950, one of ordinary skill in the art will recognize that orthopedic procedures incorporating the drill guides930and950will be substantially similar with respect to the orthopedic procedure incorporating the drill guide900as previously described except that the number of pre-drilled holes will correspond in location, spacing, and number based upon the configurations for the drill guides930and950.

In view of the foregoing embodiments illustrating implant insertion devices and orthopedic implants according to the present invention, it should be understood that implant insertion devices and orthopedic implants will fall within the scope of the present invention regardless of the body shape and number of legs for an orthopedic implant. Moreover, although the present invention has been described in terms of the foregoing embodiments, such description has been for exemplary purposes only and, as will be apparent to those of ordinary skill in the art, many alternatives, equivalents, and variations of varying degrees will fall within the scope of the present invention. That scope, accordingly, is not to be limited in any respect by the foregoing detailed description; rather, it is defined only by the claims that follow.