Steerable implant assembly

A steerable expandable implant including a base member, an adjustable member coupled to the base member, the adjustable member movable between a collapsed position and an expanded position, a pivot member rotatably received by the base member and configured to receive a tool such that the tool and the pivot member are rotatable relative to the base member between a first position and a second position, wherein the pivot member is translationally fixed relative to the base member, and a first control member received by the base member, wherein manipulation of the first control member causes the adjustable member to move between the collapsed position and the expanded position.

BACKGROUND

The present disclosure relates to expandable implants and devices, including spinal interbody and intravertebral body devices, and vertebral interbody and intravertebral devices that are expandable after spinal placement thereof.

Fusion cages, as well as other types of implants, bodies and/or devices, are frequently utilized in spinal surgery inside a vertebra (intravertebral) and/or between vertebrae of a patient (interbody), or adjacent other bone bodies. With interbody devices, one or more such spinal bodies are placed between vertebrae to provide support and promote fusion between adjacent vertebrae where such is necessary due to disease, injury, general deterioration or congenital problems. With intravertebral devices, one or more spinal bodies are placed within a vertebra. Spinal devices, such as fusion cages and/or the like, are inserted into a spinal space either anteriorly, posteriorly, laterally or posteriolaterally.

SUMMARY

One embodiment relates to a steerable expandable implant including a base member, an adjustable member coupled to the base member, the adjustable member movable between a collapsed position and an expanded position, a pivot member rotatably received by the base member and configured to receive a tool such that the tool and the pivot member are rotatable relative to the base member between a first position and a second position, wherein the pivot member is translationally fixed relative to the base member, and a first control member received by the base member, wherein manipulation of the first control member causes the adjustable member to move between the collapsed position and the expanded position.

In some embodiments, the steerable expandable implant further includes a second control member coupled to the first control member, wherein the pivot member includes a bore extending therethrough and defining a first axis, wherein a second axis of the second control member is aligned with the first axis of the pivot member when the pivot member is in the first position. In some embodiments, the first axis of the pivot member at the second position is at an angle to the second axis of the second control member when the pivot member is in the second position. In some embodiments, the base member further includes an alignment portion configured to receive an alignment member of the tool to position the tool relative to the base member in the first and second positions, and wherein the base member includes an alignment protrusion configured to slidably engage an alignment track of the second control member and align the second control member to the base member. In some embodiments, an axis of the tool is parallel to an axis of the steerable expandable implant when the pivot member is in the first position. In some embodiments, a top surface of a first adjustable and a bottom surface of the base member define a height of the steerable expandable implant and are configured to engage adjacent portions of bone. In some embodiments, translation of the first control member changes a height of the steerable expandable implant. In some embodiments, a top surface of a first adjustable member and a bottom surface of a second adjustable member define a height of the steerable expandable implant and are configured to engage adjacent portions of bone, and wherein translation of the first control member changes a height of the steerable expandable implant.

Another embodiment relates to a steerable expandable implant including a base member, one or more adjustable members coupled to the base member, the adjustable member movable between a collapsed position and an expanded position, a first control member translationally coupled and pivotally fixed relative to the base member, and a second control member slidably coupled to the first control member and the adjustable member, wherein an axis of the second control member is offset relative to an axis of the first control member, wherein manipulation of the first control member causes at least one of the adjustable member to move between the collapsed position and the expanded position.

In some embodiments, the steerable expandable implant further comprises an adjustment member threadingly coupled to the first control member, wherein rotation of the adjustment member causes movement of the first control member. In some embodiments, the steerable expandable implant further comprises a pivot member pivotally received by the base member and configured to receive a tool such that the tool and the pivot member are pivotable relative to the base member. In some embodiments, the base member further includes an alignment portion configured to receive an alignment member of the tool to align the tool to the base member. In some embodiments, a top surface of a first adjustable member and one of a bottom surface of the base member or a bottom surface of a second adjustable member define a height of the steerable expandable implant. In some embodiments, the first control member includes a first guide extending into the base member and configured to limit a range of motion of the first control member, and wherein the second control member includes a second guide extending into the base member and configured to limit a range of motion of the second control member. In some embodiments, the second control member includes a control portion configured to slidably align the second control member with the base member.

Another embodiment relates to a method of positioning a spinal implant including coupling a tool to an implant, manipulating the tool to move the implant to a desired location, rotating the tool relative to a base member of the implant, coupling a control member of the tool to a first control member of the implant, and operating the control member of the tool to change a height of the implant.

In some embodiments, rotating the tool relative to the base member includes rotating the tool until the control member of the tool is axially aligned with the first control member. In some embodiments, operating the control member includes rotating the control member of the tool to cause translation of the first control member. In some embodiments, translation of the first control member causes translation of a second control member slidably coupled to an adjustable member of the implant. In some embodiments, the second control member includes at least one control portion slideably coupled to the adjustable member and configured to cause the adjustable member to move relative to the base member responsive to translation of the second control member.

Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the disclosure, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the principles of the present disclosure. The exemplifications set out herein illustrate several embodiments, but the exemplifications are not to be construed as limiting the scope of the disclosure in any manner.

DETAILED DESCRIPTION

The present disclosure relates to steerable and expandable and/or dynamic implants, including, but not limited to, interbody (between adjacent vertebrae), intravertebral-body (inside the vertebrae) and/or spinal stabilization devices that may or may not be used as interbody fusion cages or devices, interbody/intravertebral bodies/body stabilization devices and/or the like (e.g., spinal device(s)) for providing support, stabilization and/or promoting bone growth between or inside vertebrae or other portions of bone that have been destabilized or otherwise due to injury, illness and/or the like. Particularly, the present disclosure provides various versions of dynamic (steerable and expandable/retractable) interbody/intravertebral body devices that are usable in a spinal column or other areas of a human.

Spinal interbody and intravertebral devices may be difficult to position. That is, a compact orientation, conducive to insertion, may be inconvenient to maneuver into a final position. Such spinal interbody and intravertebral devices lack the ability to change an orientation once inserted. This poses various problems with their use and/or implantation. Particularly, statically oriented spinal devices require complex positioning instruments or techniques to properly position the device and bridge the gap between adjacent vertebrae. These instruments and techniques do not lend themselves to microsurgery, arthroscopic surgery or the like.

Expandable interbody devices allow the device to be initially smaller than traditional non-expandable (static) interbody devices such that expandable interbody devices may be more easily inserted or implanted into the vertebral space. Moreover, expandable devices allow the surgeon to set the amount of expansion necessary for the particular patient rather than the static device dictating the spacing.

Various embodiments disclosed herein are directed to steerable expandable implants that are implantable between adjacent bodies of bone. For example, the implant may be implanted or inserted into a human spine adjacent upper and lower vertebrae of the spine. According to various exemplary embodiments, the components of the implants disclosed herein may be made of any suitable material(s), including a variety of metals, plastics, composites, or other suitable bio-compatible materials. In some embodiments, one or more components of the implants disclosed herein may be made of the same material, while in other embodiments, different materials may be used for different components of the various implants.

Referring now toFIG. 1-7, steerable expandable implant100is shown, according to an exemplary embodiment. Implant100is usable, for example, between and/or within vertebral bodies of the spine, and may share many of the features of the other inter/intra-body implants discussed elsewhere herein. It should be understood that implant100may, in some embodiments, be usable in other portions of the body in addition to the spine, and all such applications are to be understood to be within the scope of the present disclosure.

Implant100may be inserted into a patient while in a first orientation. Once inserted, an appropriate tool may be used to engage a portion of the implant100to reorient the implant100into a second orientation. Implant100may be positioned within a desired space (e.g., between adjacent portions of bone) while in a first, collapsed position. An appropriate tool may be used to engage a portion of implant100to manipulate implant100into a desired position. Once in a desired position, the same or a subsequent tool may be utilized to engage a portion of implant100to expand implant100to a desired degree of expansion. It should be understood that based on a particular application, implant100may be utilized in a fully collapsed position, a fully expanded position, or any intermediate position therebetween. Once implant100is properly positioned and expanded to a desired height, bone graft material may be delivered by way of an access aperture and placed into a central cavity of implant100. The various apertures in and through implant100may facilitate the growth of bone material in and around implant100to further stabilize implant100.

Referring again toFIGS. 1-7, according to an exemplary embodiment, implant100includes base member140and adjustable member120adjustably coupled to the base member140. In various embodiments, base member140includes alignment channels144and146to receive alignment portions124and126. Alignment channels144and146and alignment portions124and126may align adjustable member120to base member140. For example, the alignment features (e.g., alignment channels144and146and/or alignment portions124and126) may facilitate alignment of adjustable member120to base member140during expansion of implant100. The alignment features may couple to one another and allow for vertical (e.g., up and down, expansive and contractive, etc.) movement of base member140and adjustable member120. In some embodiments, the alignment features have a relatively close fit to facilitate alignment between adjustable member120and base member140, while in other embodiments, the alignment features have a relatively loose fit to facilitate a desired angular offset between adjustable member120and base member140. In some embodiments, alignment channels144and146and alignment portions124and126form a tongue and groove joint. In various embodiments, alignment portions124and126include pin slots125and127. Pin slots125and127may receive a pin inserted into apertures143to limit expansion and/or contraction of adjustable member120. For example, pin slots125and127may facilitate expansion of adjustable member120such that adjustable member120cannot decouple from base member140. Base member140and adjustable member120are shown to include surface patterns122and148respectively. Surface patterns122and148are configured to promote bonding to an adjacent surface (e.g., a portion of bone) and prevent slippage of implant100. In some embodiments, surface patterns122and148are patterned ridges.

Implant100includes control member200coupled to an end of base member140and usable to manipulate implant100into a location on the patient. Control member200may rotate about the end of base member140between a first position102(shown inFIG. 2) and a second position104(shown inFIG. 4). First position102may reduce the cross-sectional footprint of implant100for implantation, allowing for smaller opening incisions and less invasive surgery techniques. Second position104may facilitate positioning implant100to align with the intended implantation location, thereby allowing for less reorientation of implant100and a more straightforward implantation. Control member200may include manipulation connector202to connect a tool for manipulation of implant100during implantation. In some embodiments, manipulation connector202is a male screw thread to receive a female mating thread. Implant100may include first control shaft130received by base member140. First control shaft130may be used to expand implant100. For example, a user may use a tool to manipulate (e.g., rotate, etc.) first control shaft130thereby causing expansion of implant100. In various embodiments, an axis of first control shaft130aligns with an axis of control member200in the second position104. Control member200may include an opening to facilitate access to first control shaft130while control member200is in the second position104.

Referring now specifically toFIG. 7, first control shaft130may include or be coupled to connector132to receive a tool or other manipulation accessory. In some embodiments, connector132is a screw drive (e.g., Philips, Hex, Slot, etc.). In various embodiments, implant100includes a second control shaft110positioned between base member140and adjustable member120. Second control shaft110may facilitate adjustment of the adjustable member120by transferring a force from a user to the adjustable member120. In some embodiments, a user operates a different member (e.g., first control shaft130) which transfers the operational force to second control shaft110. First control shaft130may include engagement portion134configured to couple to contact118of second control shaft110and facilitate force transfer thereto. In some embodiments, engagement portion134is a geared portion to engage a corresponding geared portion of second control shaft110. In various embodiments, second control shaft110and first control shaft130have different axes of rotation (i.e., are at an angle to one another). For example, first control shaft130may have a first axis that is conducive to manipulation by a user during implantation, while second control shaft110may have a second axis that facilitates adjustment of adjustable member120. In some embodiments, second control shaft110includes one or more threaded portions114and116. In some embodiments, implant100includes adjustment members160and162that may couple to second control shaft110. Adjustment members160and162are shown to include threaded portions161and163respectively. Threaded portions161and163may correspond to the threaded portions114and116and couple thereto. Adjustment members160and162may translate along the axis of second control shaft110. For example, rotation of second control shaft110may cause adjustment members160and162to move toward one another or away from one another. In some embodiments, threaded portion114and threaded portion116are threaded in opposite manners (e.g., left-handed and right-handed) such that, upon rotation of second control shaft110, adjustment members160and162move in opposite directions along second control shaft110. For example, second control shaft110may be configured such that rotation of second control shaft110in a first direction (e.g., clockwise) causes adjustment members160and162to move toward each other, and rotation of second control shaft110in a second direction (e.g., counter-clockwise) causes adjustment members160and162to move away from each other.

Second control shaft110is shown to include at one end connection112to be received by corresponding slot142in base member140. Connection112may secure an end of second control shaft110and allow axial rotation of second control shaft110. Pin141may be received within a vertical aperture of base member140and secure second control shaft110. In various embodiments, pin141is received by a groove of second control shaft110thereby preventing horizontal translation of second control shaft110.

Adjustable member120may include control channels170and172(seeFIG. 7) to receive adjustment members160and162and cause an expansive or contractive translation based on movement of adjustment members160and162. As adjustment members160and162translate along second control shaft110, adjustable member120is moved upward or downward due to the angled shape of control channels170and172. The rate of movement of adjustable member120can be adjusted by modifying the slope of control channels170and172relative to second control shaft110. In some embodiments, the rate of movement of adjustable member120can be adjusted by modifying threaded portions114and116(e.g., lead, pitch, etc.) of second control shaft110. Mechanisms of expandable implants are described in further detail in U.S. patent application Ser. No. 15/645,179 filed Jul. 10, 2017, the entirety of which is incorporated by reference herein.

Base member140may include guide channels150. Guide channel150may receive pins210to couple control member200to base member140. Pins210may be received by apertures204in control member200such that pins210extend beyond apertures204and are received in guide channels150. Guide channels150may be configured to guide control member200in a path from the first position102(shown inFIG. 2) to the second position104(shown inFIG. 4). In some embodiments, control member200, while in the second position104, is configured to allow co-axial operation of first control shaft130. For example, a tool attached to manipulation connector202may allow a user to operate first control shaft130to adjust adjustable member120while control member200is in the second position104.

A non-limiting example of operation of control member200is as follows. A coaxial manipulation device may be attached to implant100via manipulation connector202. Implant100may be inserted into the patient in the first position102. In the first position102, implant100is compact to allow for easy insertion. Once inside the patient, the user may move control member200from the first position102to the second position104. In the second position104, implant100is oriented to be aligned with an intended implant location on the patient, thereby reducing the amount of manual manipulation a user must perform to reorient implant100for alignment. Furthermore, in the second position104, control member200is aligned with first control shaft130to facilitate operation of first control shaft130via the coaxial manipulation device. Once implant100is positioned in the intended location, the user may operate first control shaft130, via the coaxial manipulation device, to adjust adjustable member120to a desired level of expansion to properly contact adjacent portions of bone.

Referring now toFIGS. 8-13, steerable expandable implant300is shown, according to an exemplary embodiment. Implant300may share many of the features of the other inter/intra-body implants discussed elsewhere herein. All such combinations of features are to be understood to be within the scope of the present disclosure. Implant300is generally similar to implant100in structure and function.

Implant300includes base member340, adjustable member320, and control member400. Base member340and adjustable member320are configured to engage adjacent surfaces (e.g., portions of bone, etc.). In various embodiments, adjustable member320is coupled to base member340as described herein. Control member400is configured to facilitate manipulation of implant300. For example, using a tool coupled to control member400, a user may manipulate implant300into an implantation position. In various embodiments, base member340, adjustable member320, and/or control member400are the same or share features of base member140, adjustable member120, and/or control member200.

In various embodiments, base member340includes alignment channels344and346to receive alignment portions324and326. Alignment channels344and346and alignment portions324and326may align adjustable member320to base member340. For example, the alignment features (e.g., alignment channels344and346and/or alignment portions324and326) may facilitate alignment of adjustable member320to base member340during expansion of implant300. The alignment features may couple to one another and allow for vertical (e.g., up and down, expansive and contractive, etc.) movement of base member340and adjustable member320. In some embodiments, the alignment features have a relatively close fit to facilitate alignment between adjustable member320and base member340, while in other embodiments, the alignment features have a relatively loose fit to facilitate a desired angular offset between adjustable member320and base member340. In some embodiments, alignment channels344and346and alignment portions324and326form a tongue and groove joint. In various embodiments, alignment portions324and326include pin slots325and327. Pin slots325and327may receive a pin inserted into apertures343to limit expansion and/or contraction of adjustable member320. For example, pin slots325and327may facilitate expansion of adjustable member320such that adjustable member320cannot decouple from base member340. Base member340and adjustable member320are shown to include surface patterns322and348respectively. Surface patterns322and348are configured to promote bonding to an adjacent surface (e.g., a portion of bone) and prevent slippage of implant300. In some embodiments, surface patterns322and348are patterned ridges.

Implant300includes second control shaft310to affect an adjustment of adjustable member320. Second control shaft310may be the same or share features of second control shaft110. For example, second control shaft310may operate by a different principle than second control shaft110. As a concrete example, second control shaft310may translate horizontally, while second control shaft110may rotate. Implant300includes first control shaft330. First control shaft330may rotate about the end of base member340between a first position302(shown inFIG. 8) and a second position304(shown inFIG. 9).

Referring now specifically toFIG. 13, first control shaft330may be received within control member400and manipulation connector402. In various embodiments, first control shaft330includes engagement portion336to engage a corresponding engagement portion408of manipulation connector402. In some embodiments, manipulation connector402is a nut and engagement portions336and408are screw threads. In some embodiments, a user may rotate manipulation connector402to affect a translation (e.g., inward or outward) of first control shaft330. In some embodiments, first control shaft330includes connector332to facilitate translation of first control shaft330. For example, a user may apply an axial force (e.g., inward or outward) to first control shaft330to facilitate rotation of manipulation connector402and/or translation of first control shaft330. Connector332may be a screw drive (e.g., Philips, Hex, Slot, etc.).

Control member400may be configured to facilitate manipulation of implant300(e.g., to position implant300in an implantation location, etc.). In various embodiments, control member400may translate around an end of implant300. In some embodiments, base member340includes guide channels350to facilitate translation of control member400. In some embodiments, guide channels350are slotted grooves that receive alignment member406of manipulation connector402. For example, alignment member406may be a protruded collar of manipulation connector402that rolls along guide channels350. Additionally or alternatively, alignment member406may facilitate coupling manipulation connector402to control member400. For example, alignment member406may include a groove that is received by control member400to rotatably couple manipulation connector402to control member400. In some embodiments, rotation of manipulation connector402, via the manipulation connector402or first control shaft330, generates lateral movement across the end of implant300(e.g., along guide channels350). For example, a user may rotate manipulation connector402counter-clockwise to move control member400between the first position302and the second position304.

First control shaft330includes engagement portion334configured to facilitate coupling first control shaft300to second control shaft310. In some embodiments, engagement portion334is an aperture to accept a link. For example, first control shaft330may connect to second control shaft310via a pin or other linking mechanism. Similarly, second control shaft310includes control channel318to receive a linking mechanism to link second control shaft310to first control shaft330and to guide translation (e.g., side to side) of second control shaft310in response to translation (e.g., inward or outward) of first control shaft330.

Second control shaft310may include or be coupled to one or more interfaces314and316(e.g., control portions, etc.). In various embodiments, interfaces314and316are received within control channels370and372of adjustable member320. As second control shaft310translates, adjustable member320is moved upward or downward due to the angled shape of control channels370and372. The rate of movement of adjustable member320can be adjusted by modifying the slope of control channels370and372relative to second control shaft310. Interfaces314and316may include angled portions that are configured to interface with control channels370and372to affect a vertical (e.g., up and down, expansive or contractive) movement of adjustable member320in response to a horizontal translation (e.g., side to side) of second control shaft310. First control shaft330is configured to push or pull on second control shaft310via the linking mechanism between engagement portion334and control channel318, thereby affecting a movement of adjustable member320. Second control shaft310is shown to include contact312configured to couple to bore342of base member340. Bore342may retain second control shaft310via contact312while allowing second control shaft310to slide (e.g., in and out of bore342) freely.

A non-limiting example of operation of control member400is as follows. A coaxial manipulation device may be attached to implant300via manipulation connector402. Implant300may be inserted into the patient in the first position302. In the first position302, implant300is compact to allow for easy insertion. Once inside the patient, the user may move control member400from the first position302to the second position304. In the second position304, implant300is oriented to be aligned with an intended implant location on the patient, thereby reducing the amount of manual manipulation a user must perform to reorient implant300for alignment. Once implant300is positioned in the intended location, the user may operate first control shaft330, via the coaxial manipulation device, to adjust adjustable member320to a desired level of expansion to properly contact adjacent portions of bone.

Referring now toFIGS. 14-23, a steerable expandable implant500is shown according to an exemplary embodiment. Implant500may share many of the features of the other inter/intra-body implants discussed elsewhere herein. All such combinations of features are to be understood to be within the scope of the present disclosure. Implant500is generally similar to implant300in structure and function.

Referring now specifically toFIGS. 14-23, implant500includes base member540and adjustable member520adjustably coupled to base member540. Base member540and adjustable member520are configured to engage adjacent surfaces (e.g., portions of bone, etc.). In various embodiments, adjustable member520is coupled to base member540as described herein. In various embodiments, base member540and/or adjustable member520are the same as or share features with base member340and/or adjustable member320.

In various embodiments, base member540includes alignment channels544and546to receive alignment portions524and526. Alignment channels544and546and alignment portions524and526may align adjustable member520to base member540. For example, the alignment features (e.g., alignment channels544and546and/or alignment portions524and526) may facilitate alignment of adjustable member520to base member540during expansion of implant500. The alignment features may couple to one another and allow for vertical (e.g., up and down, expansive and contractive, etc.) movement of base member540and adjustable member520. In some embodiments, the alignment features have a relatively close fit to facilitate alignment between adjustable member520and base member540, while in other embodiments, the alignment features have a relatively loose fit to facilitate a desired angular offset between adjustable member520and base member540. In some embodiments, alignment channels544and546and alignment portions524and526form a tongue and groove joint. In various embodiments, alignment portions524and526include pin slots525and527. As shown inFIG. 22, pin slots525and527may receive a pin541inserted into apertures543to limit expansion and/or contraction of adjustable member520. For example, pin slots525and527may facilitate expansion of adjustable member520such that adjustable member520cannot decouple from base member540. Base member540and adjustable member520are shown to include surface patterns522and548respectively. Surface patterns522and548are configured to promote bonding to an adjacent surface (e.g., a portion of bone) and prevent slippage of implant500. In some embodiments, surface patterns522and548are patterned ridges.

Implant500further includes second control member510(e.g., a control shaft, etc.). In various embodiments, second control member510translates along axis508. In various embodiments, base member540, adjustable member520, and/or second control member510include apertures560(e.g., fluid apertures, bone growth material apertures, etc.), as shown inFIG. 15. Apertures560may facilitate fluid communication (e.g., for the delivery of bone growth material, etc.) between an exterior and an interior of implant500. Second control member510includes control portions514and516. Control portions514and516may include sloped portions of second control member510configured to contact corresponding sloped portions of adjustable member520and cause vertical translation or movement (e.g., up and down, expansive and contractive) of adjustable member520in response to horizontal (e.g., side to side) movement of second control member510. In various embodiments, control portions514and516are received within control channels570and572of adjustable member520. As second control member510translates, adjustable member520is moved upward or downward due to the angled shape of control channels570and572. The rate of movement of adjustable member520can be adjusted by modifying the slope of control channels570and572relative to second control member510. Control portions514and516may include angled portions that are configured to interface with control channels570and572to affect a vertical (e.g., up and down, expansive or contractive) movement of adjustable member520in response to a horizontal translation (e.g., side to side) of second control member510. In various embodiments, second control member510includes guides513and515configured to direct horizontal translation of second control member510and/or limit a range of motion of second control member510. In various embodiments, base member540may include track562, as shown inFIG. 15. Track562may receive guides513and515and direct motion thereof. For example, track562may align second control member510to base member540throughout horizontal movement, as described above. Second control member510may further include end portion512configured to couple to bore542of base member540. Bore542may retain second control member510via end portion512while allowing second control member510to slide (e.g., relative to bore542) freely. In various embodiments, bore542is formed between bridge530and end534. Bridge530may securely couple to end534thereby creating bore542to receive contact512. In some embodiments, bridge530is permanently coupled to the base member540(e.g., via welding, etc.). Second control member510may include translation surface518configured to contact adjacent surface656of first control member650(e.g., an intermediate member, control member, etc.). First control member650may receive user input as described below and transfer the user input to second control member510by contacting translation surface518. In various embodiments, surface656receives a horizontal force in a first direction from screw652and translates the horizontal force into a horizontal force in a second direction. For example, surface656may receive a first axial force along axis506and translate the force to cause axial motion of second control member510along axis508. In various embodiments, surface656is coupled to first control member650.

First control member650may be received within translation aperture648of base member540. First control member650may include screw652, guide658and surface656. Screw652may include threaded portion654configured to contact a corresponding threaded portion of adjustment collar640. In various embodiments, threaded portion654is a male screw thread to receive a female mating thread. Similar to guides513and515, guide658is configured to direct horizontal translation of first control member650(e.g., limit a range of motion of first control member650, etc.). In some embodiments, base member540includes track561, as shown inFIG. 15. Track561may receive guide658and direct motion thereof. For example, track561may align first control member650within base member540throughout horizontal translation. In various embodiments, first control member650translates along axis506. Additionally or alternatively, tracks561and562facilitate fluid communication similarly to apertures560.

Adjustment collar640(e.g., an adjustment member, etc.) may be configured to be received within adjustment aperture648such that it contacts base member540and receives first control member650. In some embodiments, base member540includes aperture535and533(e.g., as shown inFIG. 15). Aperture535and/or aperture533may receive a pin532,536(e.g., linkage, collar, etc.) to couple adjustment collar640to base member540. In some embodiments, the pin532,536is received within a groove of adjustment collar640. In various embodiments, adjustment collar640is rotatably received within adjustment aperture648. Adjustment collar640includes collar642, contact surface644, and threaded aperture646. Collar642may be a groove to maintain adjustment collar640within adjustment aperture648. Contact surface644may be configured to receive a tool to facilitate user manipulation of implant500. In various embodiments, contact surface644is a raised portion of adjustment collar640to facilitate transmission of an external rotational force to adjustment collar640. Threaded aperture646may be configured to receive screw652of first control member650and translate force thereto. In various embodiments, threaded aperture646includes a female mating thread.

Pivot member620may be received within aperture624of base member540. In various embodiments, pivot member620is cylindrical. Pivot member620may rotate between a first position502and a second position504, as shown inFIG. 14. In various embodiments, rotation of pivot member620is limited by limit602and/or limit604. For example, limit602may prevent a user using a tool from rotating pivot member620farther counter-clockwise than the first position502. In various embodiments, pivot member620may be rotatably received by aperture626such that pivot member620may rotate within aperture626but not decouple from base member540. Pivot member620may include threaded aperture622configured to receive a corresponding threaded portion of a tool. In various embodiments, pivot member620facilitates positional adjustment of implant500as described in greater detail below.

Base member540further includes tool recess610, as shown inFIG. 16. Tool recess610may be configured to receive a tool to facilitate manipulation of implant500by a user. In various embodiments, tool recess610includes slanted side walls612to facilitate coupling to a tool. Tool recess610is discussed in greater detail below with reference toFIGS. 27-34.

A non-limiting example of operation of implant500is as follows. A tool, such as a coaxial manipulation device, may be attached to implant500via pivot member620. A user may align the manipulation device to implant500using tool recess610. The user may turn pivot member620from the first position502to the second position504within aperture624, while changing an orientation of implant500. In the second position504, the user may engage adjustment collar640using the manipulation device. Rotation of adjustment collar640causes translation of first control member650(e.g., along axis506). First control member650engages of second control member510, causing translation or other movement of second control member510(e.g., along axis508). Translation of second control member510causes control portions514and516to engage control channels570and572, thereby causing expansion or contraction of adjustable member520. In various embodiments, first control member650and second control member510are coupled (e.g., via a tongue and groove joint, a dovetail interface, etc.). Rotation of adjustment collar640in a first direction may cause expansion of implant500and rotation of adjustment collar640in a second direction may cause contraction of implant500(e.g., first control member650pulls second control member510, thereby causing movement of adjustable member520).

Referring now toFIGS. 24-26, a steerable expandable implant800is shown, according to an exemplary embodiment. Implant800may share many of the features of the other inter/intra-body implants discussed elsewhere herein. All such combinations of features are to be understood to be within the scope of the present disclosure. Implant500is generally similar to implant300and implant500in structure and function.

Implant800may include base member870and adjustable member880adjustably coupled to base member880. Base member870and adjustable member880are configured to engage adjacent surfaces (e.g., portions of bone, etc.). In various embodiments, base member870and/or adjustable member880are the same as or share features with base member540and/or adjustable member520.

Base member870may include protrusion802configured to interface with pocket810in second control member860. Protrusion802may facilitate alignment of second control member860during translation of second control member860. For example, protrusion802may fit inside of pocket810(e.g., alignment channel, etc.) and align second control member860with base member870during side to side translation of second control member860. In various embodiments, protrusion802is configured to be a track that second control member860slides along. In various embodiments, second control member860includes pocket810. Pocket810may be a negative space within second control member860configured to receive protrusion802. In various embodiments, protrusion802includes aperture804(e.g., fluid apertures, bone growth material apertures, etc.), as shown inFIG. 25. Aperture804may facilitate fluid communication (e.g., for the delivery of bone growth material, etc.) between an exterior and an interior of implant800.

Implant800further includes second control member860(e.g., a control shaft, etc.). Second control member860may share many of the features of second control member510. In various embodiments, second control member860includes first control portion820configured to interface with first control member830(e.g., as shown inFIG. 24). In various embodiments, first control portion820and first control member830interface using a tongue and groove joint. In various embodiments, first control portion820includes first surface826and/or second surface827. First surface826and/or second surface827may be a portion of first control portion820at a first height. In various embodiments, first surface826is on a top of first control portion820and second surface827is on a bottom of first control portion820. In various embodiments, first control portion820includes top channel822and bottom channel823. In various embodiments, top channel822and/or bottom channel823form a groove to receive a portion of first control member830to facilitate coupling first control member830to second control member860. In various embodiments, a surface of top channel822and/or bottom channel823is at a different height than that of first surface826and/or second surface827(e.g., a surface of top channel822may be below a surface of first surface826, etc.). First control portion820may include third surface824and fourth surface825. In various embodiments, third surface824is on a top portion of first control portion820and fourth surface825is on a bottom portion of first control portion820. First surface826, second surface827, third surface824, and fourth surface825may form top channel822and/or bottom channel823. In some embodiments, a height of third surface824is different than a height of first surface826(e.g., lower than, etc.). Additionally or alternatively, a height of fourth surface825may be different than a height of second surface827.

In various embodiments, first control member830includes groove834configured to receive first control portion820. In various embodiments, first control member830includes retention portion832. Retention portion832may be a lip configured to interface with top channel822and/or bottom channel823. In various embodiments, a top portion of groove834includes retention portion832. Additionally or alternatively, a bottom portion of groove834may include retention portion832. In various embodiments, groove834and retention portion832are configured to couple first control member830to second control member860while facilitating translation of second control member860. For example, first control surface820may slide within groove834to translate movement of first control member830in a first direction to movement of second control member860in a second direction. In various embodiments, an axis of groove834and an axis of top channel822and/or bottom channel823are aligned. In various embodiments, first control portion820slideably engages first control member830. In various embodiments, first control member830is the same or similar to first control member650. For example, first control member830may be first control member650but including pocket810.

Referring now specifically toFIGS. 27-34, tool700for manipulation of implant500is shown, according to an embodiment. In brief summary, a user may operate tool700to manipulate a position of implant500and/or to expand and/or contract implant500.FIGS. 27-28illustrate tool700connecting to implant500.FIGS. 29-31illustrate rotation of implant500using tool700.FIGS. 32-34illustrate expansion of implant500using tool700.

Referring now specifically toFIGS. 27-28, tool700for manipulation of implant500is shown, according to an exemplary embodiment. Tool700is shown to include first end702and second end704. In various embodiments, a user operates tool700using second end704. First end702may include coupling portion710configured to couple to pivot member620. Coupling portion710may include threaded portion712. Threaded portion712may be a male screw thread corresponding to the female threading of threaded aperture622. A user may operate coupling portion710via the second end704to rotate the coupling portion710and cause tool700to couple to implant500. In some embodiments, tool700includes aperture706to facilitate viewing inside tool700. For example, a user may monitor rotation of coupling portion710via aperture706. Additionally or alternatively, aperture706may include one or more indicators. For example, aperture706may include an indicator to show when tool700is fully coupled to implant500. Tool700may further include coupling arm720. Coupling arm720may be configured to align tool700to implant500and facilitate manipulation of implant700. Coupling arm720includes coupling portion722configured to be received by coupling aperture610. In various embodiments, coupling portion722includes slanted portion724corresponding to slanted side walls612. For example, slanted portion724may be wedge shaped to facilitate axial (e.g., in and out) coupling of coupling arm720to coupling aperture610but prevent non-axial (e.g., side to side, up and down, etc.) uncoupling of the coupling arm720from coupling aperture610. In one embodiment, rotation of pivot member620via tool700is prevented when coupling arm720is engaged with coupling aperture610.

In various embodiments, tool700couples to implant500while pivot member620is in a first position. For example, an axis of threaded aperture622may be aligned with an axis of implant500and an axis of tool700in the first position (e.g., as shown for example inFIGS. 27-29). To attach tool700to implant500, a user may align tool700to implant500using coupling arm720by coupling coupling arm720with coupling aperture610(e.g., by extending coupling portion722within coupling aperture610). The user may then rotate coupling portion710to couple tool700to adjustable member620.

Referring now toFIGS. 29-31, rotation of tool700relative to implant500is shown, according to an exemplary embodiment. To rotate implant500using tool700, coupling arm720is retracted to decouple from implant500(e.g.,FIG. 29). A user may manipulate implant500using tool700to turn pivot member620thereby causing rotation of implant500. In various embodiments, tool700is used to rotate implant500from a first position to a second position. In the first position, an axis of implant500may be aligned with an axis of tool700. In the second position, an axis of implant500may be offset from an axis of tool700(e.g., 60° difference, etc.). A user may align implant500in the second position by extending coupling arm720to contact coupling aperture610(e.g.,FIG. 32).

Referring now toFIGS. 32-34, expansion of implant500is shown, according to an exemplary embodiment. Tool700is shown to include expansion member730. In some embodiments, expansion member730is coupled (e.g., slideably coupled) to main body701of tool700. Additionally or alternatively, expansion member730may be removably coupled to tool700such that it may contact and/or couple to tool700during use and decouple from tool700when not in use. Expansion member730may be configured to contact and rotate contact surface654and/or contact surface644, as shown inFIG. 34. Expansion member730may contact an adjacent surface708of tool700configured to receive and align expansion member730. Adjacent surface708may be a concave trough configured to correspond to a shape of expansion member730. Expansion member730includes first end732and second end734. In various embodiments, a user manipulates expansion member730via second end734. First end732may couple to contact surface654to facilitate rotation thereof. For example, first end732may include a female recessed surface corresponding to the male raised portion of contact surface654.

In various embodiments, a user couples expansion member730to contact surface654by extending expansion member730down the axis of tool700to contact contact surface654. The user may manipulate expansion member730to rotate expansion member730. Rotation of expansion member730transfers rotational force to adjustment collar640. Rotation of adjustment collar640causes translation of screw652(e.g., in and out along axis506). Translation of screw652causes surface656to contact translation surface518, thereby causing horizontal translation of translation surface518. For example, expansive rotation (e.g., rotation causing screw652to translate into implant500) of expansion member730causes second control member510to translate horizontally along an axis of implant500in the direction of bridge530(e.g., away from pivot member620) thereby causing control portions514and516to contact control channels570and572and cause expansion of adjustable member120. Rotation of expansion member730may thereby cause expansion or contraction of implant500. In various embodiments, second control member510operates similarly as described with reference to implant300.

Steerable expandable implants, such as implant100, implant300, or implant500, as disclosed herein, offer many advantages over traditional implants. Steerable expandable implants (e.g., implant100, implant300, and implant500) may change a position of a control member (e.g., manipulation connector202, manipulation connector402, pivot member620, etc.) to better orient the implant into an implantation location (i.e., a location between vertebrae of the spine). Traditional implants may have to be manually oriented for implantation. For example, an implant may be manually pushed or twisted using forceps into an implantation location, which is not conducive to microsurgery, arthroscopic surgery or the like. In addition, operation of a portion of the steerable expandable implant (e.g., manipulation connector202, manipulation connector402, pivot member620) may change a position of the implant. Additionally or alternatively, operation of the portion of the steerable expandable implant may expand the implant. Traditional implants lack a single control mechanism to control multiple aspects of the implant. In contrast, the steerable expandable implants disclosed herein (e.g., implant100, implant300, implant500), can control orientation and expansion of the implant from a single mechanism, reducing the complexity of implantation and the number of specialized tools required. Furthermore, the steerable expandable implants disclosed herein may be inserted in a compact orientation (e.g., laterally) to reduce the size of an insertion necessary to fit the implant before being oriented into a final orientation (e.g., horizontally) for positioning into an implantation location.

Referring now toFIG. 35, method1401of positioning an implant is shown, according to an exemplary embodiment. Method1401may be used with the implants disclosed herein (e.g., implant100, implant300, implant500etc.), or another implant altogether. Referring now to method1401generally, method1401may be used to more easily insert and position an implant between adjacent bodies of bone. For example, method1401may be used to implant or insert an implant into a human spine adjacent upper and lower vertebrae of the spine.

At step1400, a user may connect a tool to a pivot member of an implant. For example, the user may connect a manipulation device (e.g., tool700, etc.) to a steerable control member of the implant. In some embodiments, the steerable control member is the same as or similar to the control member200, control member400, and/or pivot member620. In some embodiments, the steerable control member is in a first position that configures the implant in a compact orientation. For example, the steerable control member may align the implant to be inserted lengthwise such that the implant is generally axially aligned with the manipulation device. At step1410, the user may insert the implant into the insertion region. For example, the implant may be inserted through an incision. In some embodiments, the implant may be inserted in a first position. For example, the implant may be inserted laterally. That is, the implant may be oriented such that the smallest cross-sectional area must fit through the incision gap. In some embodiments, step1410roughly positions the implant before the implant is reoriented to a different orientation more convenient to positioning and manipulation.

At step1420, the user may operate the tool to pivot the pivot member. For example, the user may operate the steerable control member of the implant to move the steerable control member to a second position. In some embodiments, the steerable control member is the same as or similar to first control shaft130and/or first control shaft330. In some embodiments, the second position is such that the implant is oriented at an angle to the manipulation device for alignment with a final implantation location, as seen inFIG. 4, for example. Operation of the steerable control member may change an orientation of the implant such that the axis of the implant changes from being generally parallel with the manipulation device to being generally slanted (e.g., offset by 45°) from the manipulation device. In some embodiments, the user operates the manipulation device to move the steerable control member (e.g., control member200, control member400, pivot member620) to the second position. At step1430, the user may manipulate the implant, using the tool, to a location. For example, the user may steer the implant into an anterior position on a vertebral body of the patient. At step1440, the user may operate a first control member (e.g., first control shaft130, first control shaft330, adjustment collar640) of the implant to expand an adjustable member of the implant from a collapsed position to an expanded position. In some embodiments, the user may connect the manipulation device to the control shaft before operation. For example, the user may couple a control member of the tool to a control member of the implant. In some embodiments, the expanded position is similar to the expanded position shown inFIG. 5. In an expanded position, the implant may contact adjacent portions of bone to provide therapeutic benefits. For example, the implant may stabilize vertebra and/or promote bone grow.

It is important to note that the construction and arrangement of the elements of the various implants and implant components as shown in the exemplary embodiments are illustrative only. Although a few embodiments have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited in the various embodiments. Accordingly, all such modifications are intended to be included within the scope of the present disclosure as defined in the appended claims. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and/or omissions may be made in the design, operating conditions, and arrangement of the exemplary embodiments without departing from the spirit of the present disclosure.