Patent ID: 12201331

DETAILED DESCRIPTION FOR CARRYING OUT THE INVENTION

Generally stated, disclosed herein are implants and systems for correcting bone deformities. Further, methods for correcting bone deformities using the implants and systems are discussed.

In this detailed description and the following claims, the words proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part or portion of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, “proximal” means the portion of a device or implant nearest the torso, while “distal” indicates the portion of the device or implant farthest from the torso. As for directional terms, “anterior” is a direction towards the front side of the body, “posterior” means a direction towards the back side of the body, “medial” means towards the midline of the body, “lateral” is a direction towards the sides or away from the midline of the body, “superior” means a direction above and “inferior” means a direction below another object or structure. Further, specifically in regards to the foot, the term “dorsal” refers to the top of the foot and the term “plantar” refers the bottom of the foot.

Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current devices, systems, instrumentation and methods are described herein with reference to use with the bones of the ankle, the bones of the foot, ankle and lower leg may be used to describe the surfaces, positions, directions or orientations of the devices, systems, instrumentation and methods. Further, the devices, systems, instrumentation and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the devices, systems, instrumentation and methods, and the aspects, components, features and the like thereof, described and/or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the disclosure. For example, the devices, systems, instrumentation and methods, and the aspects, components, features and the like thereof, described herein with respect to the right leg may be mirrored so that they likewise function with the left leg. Further, the devices, systems, instrumentation and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the leg for brevity purposes, but it should be understood that the devices, systems, instrumentation and methods may be used with other bones of the body having similar structures.

Referring now toFIGS.1-14, an implant100is shown. The implant100is an IM nail or crossing screw. The implant100includes a first member or outer sheath110, a second member or inner rod150, a coupling member130to secure the first member110to the second member150at the first or proximal end102, and a tension screw190to secure the first member110to the second member150at the second or distal end104.

With continued reference toFIGS.1-14, the first member110includes a body portion or shaft112, a deformable member120coupled to a first end of the body portion112, and a distal end portion140coupled to a second end of the body portion112. The first member110also includes a first or proximal through hole or fastener hole114positioned near the deformable member120and at least one second through hole or fastener hole116positioned near the distal end portion140. The holes114,116may be, for example, elongated or oval holes. The holes114,116may extend through the body portion112from one side to the other perpendicular to the longitudinal axis of the first member110. The holes114,116may be, for example, sized and shaped or configured to receive a bone screw or bone fastener. The body portion112may also include at least one anti-rotation pin opening118extending through the body portion112from one side to the other side. The pin opening118is, for example, sized and shaped or configured to receive an anti-rotation pin106. The first member110may also include a through hole122extending through the first member110along the longitudinal axis of the first member110.

As shown inFIGS.1-8and11-14, the deformable member, spring or proximal external spring member120is coupled to the first end of the body portion112. When inserted into a patient, the proximal external spring120resides inside the tibia anatomically. The spring120may be inserted, for example, in a first compressed position and once implantation is complete, the spring120may move to at least one second partially compressed position. As shown, the deformable member120is a helical cut, machined spring. The helical spring120is cut into, one piece, or integral with the outer sheath110of the nail100. The spring120may be compressed to provide stored energy required to apply a compressive force to the tibio-talar joint by “pulling” the talus toward the tibia once implanted.

The distal end portion140of the first member110includes a shaft or body142coupled to the second end of the body portion112. The distal end portion140may also include a distal or second through hole or fastener hole144positioned near the second end104of the implant100. The through hole144may extend through the body142from one side to the other side perpendicular to the longitudinal axis of the first member110. As shown inFIG.14, the distal end portion140may also include a threaded portion146positioned on an interior surface of the through hole122of the first member110.

With continued reference toFIGS.3,4,13and14, the second member or inner rod150includes a body portion or shaft152with an inner rod clip160coupled to and extending away from a first end of the second member150and a distal end portion170coupled to and extending away from a second end of the second member150. The second member150may also include a first or proximal through hole or fastener hole154for receiving a bone screw or bone fastener. The through hole154may be positioned, for example, near the inner rod clip160. The through hole154may be positioned to align with the through hole114of the first member110when assembled. The second member150may further include at least one second through hole or fastener hole156positioned near the distal end portion170. The second through holes156may be positioned to align with the second through holes116of the first member110when assembled. The second member150may also include at least one anti-rotation pin opening158configured or sized and shaped to receive an anti-rotation pin106. The pin opening158may be, for example, positioned to align with the pin opening118to allow the pin106to be inserted through the pin opening118and pin opening158to secure the first member110to the second member130.

As shown inFIGS.3,4,9,13and14, the inner rod clip160includes a base portion162coupled to and extending away from the body portion152. The inner rod clip160may also include an anti-rotation pin opening164extending through the inner rod clip160and configured or sized and shaped to receive a pin106. When assembled, at least a first portion of the base portion162is positioned within the through hole122and surrounded by the deformable member120and at least a second portion of the base portion162is positioned within the through hole134of the coupling member130, as shown inFIGS.3and4. In an alternative embodiment, the inner rod clip160may include a slot (not shown) machined into it to allow for flexible tines (not shown). Once the tines of the inner rod clip160engage the outer sheath110, the tines can help to prevent dissociation. The tines also transfer and hold the forces of the external spring120.

The distal end portion170includes a shaft or body172extending away from the body portion152at an end opposite the base portion162. The distal end portion170also includes a second or distal through hole or fastener hole174for receiving a bone screw or bone fastener. The distal end portion170further includes a coupling portion176. The coupling portion176includes an opening178extending into the distal end portion170from the second end. The opening178may include internal threads along at least a portion of the opening. The coupling portion176may also include alignment recesses180inset into the coupling portion176from the second end. The alignment recesses180may engage corresponding alignment protrusions in the tension screw190. The coupling portion176may also include external threads182surrounding the circumference of the second end.

With continued reference toFIGS.3,4,13and14, the tension screw190may include a body portion192with at least one groove194inset into the exterior surface of the body portion192. The tension screw190may also include a coupling protrusion196extending away from the first end of the tension screw190. The coupling protrusion196may include an interior threaded portion198positioned along the interior surface of the through hole202and an exterior threaded portion200surrounding the circumference of the exterior surface of the protrusion196. The tension screw190may also include a tool engagement opening or drive opening204to receive a tool to remove the pre-loaded compression from the implant100. The tension screw190holds the proximal external spring120in compression. The tension screw190may be, for example, releasably couplable with the implant100such that manipulation and/or release of the tension screw190actuates the proximal external spring120from a pre-loaded (e.g., compressed) position to a loaded (e.g., at least partially compressed) position. Thus, the implant100may be ready for insertion into a patient in a “pre-loaded” position, which includes compression of the deformable member120and positioning the anti-rotation pins106at the bottom of their respective slots.

Referring now toFIGS.15-30, a dynamic nail, a dual spring dynamic nail or dual spring implant300is shown. The nail300has a first end302, a second end304and a through hole306extending through the nail300along a longitudinal axis. The implant300is an IM nail or crossing screw. The implant300includes a first member or outer sheath310, a second member or inner rod330, a coupling member130to secure the first member310to the second member330at the first or proximal end302, and a tension screw190to secure the first member310to the second member330at the second or distal end304. The coupling member130and the tension screw190are of the type described above with reference to implant100, which will not be described again here for brevity sake. The tension screw190may be, for example, releasably couplable with the implant300such that manipulation and/or release of the tension screw190actuates the proximal external spring120from a pre-loaded (e.g., compressed) position to a loaded (e.g., at least partially compressed) position.

With continued reference toFIGS.15-30, the first member310includes a body portion112, a deformable member120coupled to a first end of the body portion112, and a distal end portion320coupled to a second end of the body portion112. The first member310also includes a first or proximal through hole or fastener hole114positioned near the deformable member120and at least one second through hole or fastener hole116positioned near the distal end portion320. The holes114,116may be, for example, elongated or oval holes. The holes114,116may extend through the body portion112from one side to the other perpendicular to the longitudinal axis of the first member310. The holes114,116may be, for example, sized and shaped or configured to receive a bone screw or bone fastener308, as shown inFIGS.29and30. The body portion112may also include at least one anti-rotation pin opening312extending through the body portion112from one side to the other side and positioned between the hole114and the deformable member120. The pin opening312is, for example, sized and shaped or configured to receive an anti-rotation pin106. The first member310may also include a through hole306extending through the first member310along the longitudinal axis of the first member310.

The distal end portion320of the first member310is coupled to the second end of the body portion112, as shown inFIGS.17,18and25-28. The distal end portion320may also include a first through hole or fastener hole322positioned near the body portion112of the implant300. The distal end portion320may further include a second through hole or fastener hole326that may extend through the distal end portion320from one side to the other side perpendicular to the longitudinal axis of the first member310. In addition, the distal end portion320may include an anti-rotation pin opening324extending through the distal end portion320from one side to the other side. The pin opening324is, for example, sized and shaped or configured to receive an anti-rotation pin106. As shown inFIG.28, the distal end portion320may also include a threaded portion328positioned on an interior surface of the through hole306of the first member310.

With continued reference toFIGS.17,18and25-28, the second member or inner rod330includes a shaft or body portion332with an inner rod clip340coupled to and extending away from a first end of the second member330and a second deformable member, second spring, or internal spring350coupled to and extending away from a second end of the body portion332of the second member330. The body portion332of the second member330may also include a first or proximal through hole or fastener hole334for receiving a bone screw or bone fastener308. The through hole334may be positioned, for example, near the inner rod clip340. The through hole334may be positioned to align with the through hole114of the first member310when assembled. The second member330may further include at least one second through hole or fastener hole336positioned near the second deformable member350. The second through holes336may be positioned to align with the second through holes116of the first member310when assembled. The second member330may also include at least one anti-rotation pin opening338configured or sized and shaped to receive an anti-rotation pin106. The pin opening338may be, for example, positioned to align with the pin opening312to allow the pin106to be inserted through the pin opening312and pin opening338to secure the first member310to the second member330.

As shown inFIGS.17,18and25-28, the inner rod clip340includes a base portion342coupled to and extending away from the body portion332. The inner rod clip340may also include an anti-rotation pin opening344extending through the inner rod clip340and configured or sized and shaped to receive a pin106. When assembled, the base portion342is positioned within the through hole306of the first member310and surrounded by the deformable member120, as shown inFIGS.17and18. In an alternative embodiment, the inner rod clip340may include a slot (not shown) machined into it to allow for flexible tines (not shown). Once the tines of the inner rod clip340engage the outer sheath310, the tines can help to prevent dissociation. The tines also transfer and hold the forces of the external and internal springs120,350.

The second deformable member350is a helical cut, machined spring. The helical spring350is cut into, one piece, or integral with the inner rod330of the nail300. The spring350may include a first through hole or fastener hole352extending through the spring350from one side to the other side and a second through hole or fastener hole354extending through the spring350from the one side to the other side. The spring350may also include an anti-rotation pin opening356extending through the spring350from one side to the other side and positioned between the first through hole352and the second through hole354. The second spring350may also include a coupling portion358positioned on the second or distal end of the second member330. The coupling portion358may include an opening360with internal threads positioned on the interior surface of the opening360. The coupling portion358also includes alignment recesses362inset into the second end of the spring350. The alignment recesses362may engage corresponding alignment protrusions in the tension screw190. The coupling portion358may also include external threads364surrounding the circumference of the second end.

Referring now toFIGS.31-44, another implant400is shown. The implant400may be, for example, a dynamic nail, a dynamic nail, a single spring dynamic nail, IM nail, or crossing screw. The implant400includes a first member or outer sheath410, a second member or inner rod450, a coupling member430to secure the first member410to the second member450at the first or proximal end402, and a tension screw490to secure the first member410to the second member450at the second or distal end404.

With continued reference toFIGS.31-44, the first member410includes a body portion or shaft412, a deformable member420coupled to a first end of the body portion412, and a distal end portion440coupled to a second end of the body portion412. The first member410also includes a first or proximal through hole or fastener hole414positioned near the deformable member420and at least one second through hole or fastener hole416positioned near the distal end portion440. The holes414,416may be, for example, elongated or oval holes. The holes414,416may extend through the body portion412from one side to the other side and may be oriented perpendicular to the longitudinal axis of the first member410. The holes414,416may be, for example, sized and shaped or configured to receive a bone screw or bone fastener. The body portion412may also include at least one anti-rotation pin opening418extending through the body portion412from one side to the other side. The pin opening418is, for example, sized and shaped or configured to receive an anti-rotation pin406. The pin opening418may extend through the body portion412, for example, perpendicular to the holes414,416. The first member410may also include a through hole422extending through the first member410along the longitudinal axis of the first member410.

As shown inFIGS.31-38and41-44, the deformable member, spring or proximal external spring member420is coupled to the first end of the body portion412. When inserted into a patient, the proximal external spring420is positioned anatomically inside the tibia. The spring420may be inserted, for example, in a first compressed position and once implantation is complete, the spring420may move to at least one second partially compressed position. As depicted, the deformable member420is, for example, a helical cut, machined spring. The helical spring420may be, for example, cut into, one piece, or integral with the outer sheath410of the nail400. The spring420may be compressed to provide stored energy required to apply a compressive force to the tibio-talar joint by “pulling” the talus toward the tibia once implanted.

The distal end portion440of the first member410includes a shaft or body442coupled to the second end of the body portion412. The distal end portion440may also include a distal or second through hole or fastener hole444positioned near the second end404of the implant400. The second through hole444may be, for example, elongated or oval holes. The through hole444may extend through the body442from one side to the other side perpendicular to the longitudinal axis of the first member410. As shown inFIG.44, the distal end portion440may also include a threaded portion446positioned on an interior surface of the through hole422of the first member410. The distal end portion440may also include at least one protrusion or tooth448positioned at the second end of the first member410.

With continued reference toFIGS.33,34,43and44, the second member or inner rod450includes a body portion or shaft452with an inner rod clip460coupled to and extending away from a first end of the second member450and a distal end portion470coupled to and extending away from a second end of the second member450. The second member450may also include a first or proximal through hole or fastener hole454for receiving a bone screw or bone fastener. The through hole454may be positioned, for example, near the inner rod clip460. The through hole454may be positioned to align with the through hole414of the first member410when assembled. The second member450may further include at least one second through hole or fastener hole456positioned near the distal end portion470. The at least one second through hole456may be, for example, two through holes456, as shown in the depicted embodiment. The second through holes456may be positioned to align with the second through holes416of the first member410when assembled. The second member450may also include at least one anti-rotation pin opening458configured or sized and shaped to receive an anti-rotation pin406. The pin opening458may extend, for example, through the body452in a first direction while the holes454,456extend through the body452in a second direction with the first direction being generally perpendicular to the second direction. The pin opening458may be, for example, positioned to align with the pin opening418to allow the pin406to be inserted through the pin opening418and pin opening458to secure the first member410to the second member430.

As shown inFIGS.33,34,43and44, the inner rod clip460includes a stop portion462coupled directly to the body portion452at a first end of the inner rod clip460. The inner rod clip460may have, for example, a first diameter and the stop portion462may have, for example, a second diameter that is larger than the first diameter. The second diameter of the stop portion462may also be, for example, smaller than the diameter of the body452. The inner rod clip460may also include a coupling portion464positioned at a second end of the inner rod clip460. The coupling portion464may have, for example, a third diameter that is larger than the first diameter of the inner rod clip460. The coupling portion464may also include an anti-rotation pin opening466extending through the coupling portion464and is configured or sized and shaped to receive a pin406. The inner rod clip460may also include at least one protrusion468extending circumferentially away from the inner rod clip460. As shown, the at least one protrusion468may be, for example, two protrusions spaced along the longitudinal axis of the inner rod clip460. The at least one protrusion468may be, for example, configured or sized and shaped to have an exterior diameter approximately the same size as the interior diameter of the deformable member420. When assembled, the base portion462is positioned within the through hole422and surrounded by the deformable member420, as shown inFIGS.33and34. In an alternative embodiment, the inner rod clip460may include a slot (not shown) machined into it to allow for flexible tines (not shown). Once the tines of the inner rod clip460engage the outer sheath410, the tines can help to prevent dissociation. The tines also transfer and hold the forces of the external spring420.

The distal end portion470includes a shaft or body472extending away from the body portion452at an end opposite the inner rod clip460. The distal end portion470also includes at least one second or distal through hole or fastener hole474for receiving a bone screw or bone fastener. As shown, the at least one second through hole474may be two second through holes474. The distal end portion470further includes a coupling portion476. The coupling portion476includes an opening478extending into the distal end portion470from the second end. The opening478may include internal threads along at least a portion of the opening478.

With continued reference toFIGS.33,34,43and44, the tension screw490may include a body portion492with a circumferential flange or protrusion494positioned near the second end of the body portion492. The tension screw490may also include a coupling protrusion496coupled to and/or extending away from the second end of the body portion492. The coupling protrusion496may also extend away from the flange494to the second end of the tension screw490. The coupling protrusion496may include, for example, an exterior threaded portion498for engaging the internal threads of the through hole478to place the implant400into tension. The tension screw490may also include a recessed region500extending into the first end of the body portion492. The recessed region500may include, for example, a drive opening or tool engagement opening502for receiving an insertion, removal or adjustment tool. The tool engagement opening502may receive a tool to remove the pre-loaded compression from the implant400. The tension screw490holds the proximal external spring420in compression. Thus, the implant400may be ready for insertion into a patient in a “pre-loaded” position, which includes compression of the deformable member420and positioning the anti-rotation pins406at the bottom of their respective slots. More specifically, the tension screw490may be, for example, releasably couplable with the implant400such that manipulation and/or release of the tension screw490actuates the proximal external spring420from a pre-loaded (e.g., compressed) position to a loaded (e.g., at least partially compressed) position.

The IM nails100,300,400provide, for example, continuous compression across both the tibio-talar or ankle joint and the talo-calcaneal or subtalar joint. The IM nails100,300,400provide continuous compression at the joints to ensure that bony apposition is maintained throughout the healing process. In an embodiment, the IM nails300allow for different compressive loads at each joint. The internal spring350and external spring120provide compression to the two joints independently, thereby providing the optimum compression at each joint to promote bone healing and prevent joint gaping. The IM nail300provides continual compression in the tibio-talo-calcaneal joints of the ankle, between the talus and tibia, as well as talus and calcaneus. The compression is dynamized to allow for continual compression on the joint surfaces as bone resorption, or remodeling, occurs.

A method of using the implant100,300,400, as shown inFIGS.29and30. The method may be performed to aid in TTC fusions of the ankle complex. The method may include obtaining a pre-compressed implant100,300,400. The implant100,300,400may be inserted in a pre-loaded compressed position. For example, the method may include inserting the implant100,300,400into the patient with the spring120,420in the compressed position. The method further includes inserting crossing screws or fasteners308through the patient's bones and the implant100,300,400. The implant100,300,400may remain in the compressed position while the fasteners308are inserted. After the fasteners308are inserted, the disposable tension screw is released or removed to activate the compression and the implant100,300,400moves to a second loaded position that may be, for example, at least partially compressed. For example, the tension screw190,490may be, for example, releasably couplable with the implant100,300,400such that manipulation and/or release of the tension screw190,490actuates the proximal external spring120from a pre-loaded (e.g., compressed) position to a loaded (e.g., at least partially compressed) position. Finally, the surgical incision is closed.

Referring now toFIGS.45-46, a dynamic nail system or curved nail system is shown. The nail system includes a curved nail or curved implant550, a first fastener570, and at least one second fastener. The curved nail550may have a first end552and a second end554. The nail550may include a shaft or body portion556extending between the first end552and the second end554. The curved nail550may also include at least one proximal or first through hole558positioned near the first end552. Further, the curved nail550may include at least one distal or second through hole560positioned near the second end. The second through hole560may be, for example, an elongated or oval hole560extending through the nail550at an angle. The first through holes558may extend through the nail550in a first direction and the second through hole560may extend through the nail550in a second direction. The first direction of through hole560may be positioned, for example, rotated circumferentially with respect to or offset from the second direction of the second through holes558.

Referring now toFIGS.46-47, the implant550inserted into a patient's ankle590is shown. The nail550may be inserted as shown inFIGS.46and47in a compressed state. Next, the fasteners570,580may be inserted into the patient's lower extremity590and through the nail550. Specifically, the first fastener570may be inserted through the distal through hole560and across the patient's joint. The second fasteners580may be inserted through the at least one proximal through hole558and across the patient's joint.

As may be recognized by those of ordinary skill in the art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present disclosure without departing from the scope of the disclosure. The components of the instruments, guides, implants, plates, and/or systems as disclosed in the specification, including the accompanying abstract and drawings, may be replaced by alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent or similar purpose as known by those skilled in the art to achieve the same, equivalent or similar results by such alternative component(s) or feature(s) to provide a similar function for the intended purpose. In addition, the instruments, guides, implants, plates, and/or systems may include more or fewer components or features than the embodiments as described and illustrated herein. For example, the components and features ofFIGS.1-14,FIGS.15-30,FIGS.31-44andFIGS.45-47may be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Further, the steps of the surgical methods associated with the systems ofFIGS.1-14,FIGS.15-30,FIGS.31-44andFIGS.45-47may be used interchangeably and in alternative combinations as would be modified or altered by one of skill in the art. Accordingly, this detailed description of the currently-preferred embodiments is to be taken in an illustrative, as opposed to limiting of the disclosure.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as “has”, and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (and any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises,” “has,” “includes,” or “contains” one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that “comprises,” “has,” “includes,” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

The invention has been described with reference to the preferred embodiments. It will be understood that the operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.