BONE FIXATION AND FUSION DEVICE
20200229943 ยท 2020-07-23
Inventors
Cpc classification
A61F2/4601
HUMAN NECESSITIES
A61F2002/2835
HUMAN NECESSITIES
A61F2002/30772
HUMAN NECESSITIES
A61F2002/30736
HUMAN NECESSITIES
A61F2/30744
HUMAN NECESSITIES
A61F2002/30841
HUMAN NECESSITIES
A61F2002/3085
HUMAN NECESSITIES
A61F2/446
HUMAN NECESSITIES
A61F2310/00796
HUMAN NECESSITIES
A61F2220/0041
HUMAN NECESSITIES
A61F2002/3052
HUMAN NECESSITIES
A61F2002/4627
HUMAN NECESSITIES
A61F2/447
HUMAN NECESSITIES
A61F2002/30579
HUMAN NECESSITIES
A61F2002/30405
HUMAN NECESSITIES
A61F2002/30433
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2310/00976
HUMAN NECESSITIES
A61F2220/0025
HUMAN NECESSITIES
A61F2/4465
HUMAN NECESSITIES
A61F2002/4629
HUMAN NECESSITIES
International classification
Abstract
Disclosed is a bone fusion cage that contains bone graft and is implanted between bones in a skeletal system. The cage bears structural loads that are transmitted through the bones of the skeletal system and at least partially shields the contained bone graft from the structural loads. The cage is configured to provide a secondary load to the bone graft independent of the structural load to promote fusion of the bone graft to adjacent bones.
Claims
1-6. (canceled)
7. A method of using a fusion implant to reconstruct a defective portion within a spinal segment of a subject, the spinal segment comprising a superior vertebral bone, an inferior vertebral bone and an intervening intervertebral disc space, and the defective portion extending from an inferior aspect of the superior vertebral bone to a superior aspect of the inferior vertebral bone and disrupting transmission of a vertical load along a longitudinal axis of the spinal segment, the method comprising: coupling an implant placement assembly to a proximal side wall of the fusion implant, the fusion implant comprising: (i) an upper abutment member configured to abut the inferior aspect of the superior vertebral and comprising a least one feature that is configured to increase fixation of the fusion implant onto bone, (ii) a lower abutment member configured to abut the superior surface of the inferior vertebral, the lower abutment member positioned a first distance from the upper abutment surface; (iii) a distal side wall positioned opposite the proximal wall, the distal side wall and the proximal side wall being separated by a second distance when measured along a second axis; (iv) an internal cavity positioned at least partially between the proximal side wall and the distal side wall; and (v) a load member that is movable relative to the proximal side wall and configured to transition from a first position to a second position at least partially within the internal cavity; placing a bone forming material within the internal cavity of the fusion implant; positioning the fusion implant at least partially within the defective portion, such that the upper abutment member of the fusion implant abuts the inferior aspect of the superior vertebral bone and the lower abutment member of the fusion implant abuts the superior aspect of the inferior vertebral bone, the positioning causing at least a portion of the vertical load to be transmitted through the fusion implant; and using a displacement instrument to transition the load member from the first position to the second position; wherein the transitioning the load member from the first position to the second position causes at least: (i) a decrease of a distance between the load member and the distal side wall along the direction of the second axis while the first distance and the second distance remain unchanged, and (ii) the load member to apply a compressive force onto the bone forming material contained in the internal cavity.
8. The method of claim 7, further comprising disengaging the displacement instrument from the fusion implant after the transitioning the load member from the first position to the second position has been completed.
9. The method of claim 8, wherein after the disengaging the displacement instrument has been completed, the load member is retained at a distance from the distal side wall, as measured along the direction of the second axis, which is reduced relative to a distance from the side wall when in the load member was in the first position.
10. The method of claim 7, wherein the compressive force applied by the load member comprises a load component extending along a direction that is non-parallel to the longitudinal axis of the spinal segment.
11. The method of claim 7, wherein the compressive force applied by the load member comprises a vertical load component, the vertical load component extending along a direction which is at least approximately parallel to the longitudinal axis of the spinal segment.
12. The method of claim 7, wherein the placing the bone forming material within the internal cavity of the fusion implant occurs prior to the positioning the fusion implant at least partially within the defective portion.
13. The method of claim 7, wherein the placing the bone forming material within the internal cavity of the fusion implant occurs while the implant placement assembly is coupled to the proximal side wall of the fusion implant.
14. The method of claim 7, wherein the placing the bone forming material within the internal cavity of the fusion implant occurs subsequent to completion of the positioning the fusion implant at least partially within the defective portion.
15. The method of claim 7, wherein implant attachment assembly further comprises the displacement instrument.
16. The method of claim 7, wherein the using the displacement instrument to transition the load member from the first position to the second position comprises using the displacement instrument to transition while the implant placement assembly is coupled to the fusion implant.
17. The method of claim 7, wherein the positioning the fusion implant at least partially within the defective portion comprises positioning the fusion implant such that the load member does not bear at least a portion of the vertical load transmitted from the superior vertebral bone to the inferior vertebral bone and through the fusion implant.
18. The method of claim 7, wherein the fusion implant further comprises a coupling member providing a biasing force on the load member towards the second position of the load member, and wherein the using the displacement instrument to transition the load member from the first position to the second position comprises at least using the biasing force.
19. The method of claim 7, wherein the fusion implant further comprises a mechanism configured to bias the load member towards the second position.
20. The method of claim 7, further comprising preloading the load member with a biasing force, the biasing force urging transition of the load member from the first position to the second position.
21. The method of claim 7, wherein: the fusion implant comprises a non-expandable device; and the second distance comprises a fixed distance.
22. A method of using a fusion implant to reconstruct a defective portion within a spinal segment of a subject, the spinal segment comprising a superior vertebral bone, an inferior vertebral bone and an intervening intervertebral disc space, wherein the defective portion extends from an inferior aspect of the superior vertebral bone to a superior aspect of the inferior vertebral bone and disrupts transmission of a vertical load along a longitudinal axis of the spinal segment, the method comprising: coupling an implant placement assembly to the fusion implant, the fusion implant comprising: (i) an upper abutment member configured to abut the inferior aspect of the superior vertebral and comprising a least one feature configured to increase fixation of the upper abutment member onto bone, (ii) a lower abutment member configured to abut the superior surface of the inferior vertebral and positioned a first distance from the upper abutment surface; (iii) a distal side wall positioned opposite a proximal side wall, the distal side wall and the proximal side wall being separated by a second distance when measured along a second axis; (iv) an internal cavity positioned at least partially between the proximal side wall and the distal side wall; and (v) a load member configured to transition from a first position to a second position at least partially within the internal cavity; inserting a bone forming material within the internal cavity of the fusion implant; positioning the fusion implant at least partially within the defective portion, such that the upper abutment member of the fusion implant abuts the inferior aspect of the superior vertebral bone and the lower abutment member of the fusion implant abuts the superior aspect of the inferior vertebral bone, the positioning causing at least a portion of the vertical load to be transmitted through the fusion implant; and using at least the displacement instrument, transitioning the load member from the first position to the second position while the implant placement assembly is coupled to the fusion implant; wherein the act of transitioning the load member from the first position to the second position: (i) decreases a distance between the load member and the distal side wall of the fusion implant along the second axis while the first distance and the second distance remain unchanged, and (ii) causes the load member to apply a compressive force onto the bone forming material contained in the internal cavity.
23. The method of claim 22, further comprising disengaging the displacement instrument from the fusion implant after the transitioning the load member from the first position to the second position has been performed.
24. The method of claim 23, wherein after the disengaging the displacement instrument is performed, the load member is retained at a lesser distance from the distal side wall, as measured along the direction of the second axis, than the distance of the load member from the distal side when the load member in the first position.
25. The method of claim 22, wherein the compressive force applied by the load member comprises an at least partly transverse load component, the at least partly transverse load component extending along a direction that is non-parallel to the longitudinal axis of the spinal segment.
26. The method of claim 22, wherein the compressive force applied by the load member comprises a vertical load component, the vertical load component extending along the direction of the longitudinal axis of the spinal segment.
27. The method of claim 22, wherein the inserting the bone forming material within the internal cavity of the fusion implant is performed prior to the positioning the fusion implant at least partially within the defective portion.
28. The method of claim 22, wherein the inserting the bone forming material within the internal cavity of the fusion implant is performed while the implant placement assembly is coupled to the fusion implant.
29. The method of claim 22, wherein the inserting the bone forming material within the internal cavity of the fusion implant is performed subsequent to the positioning the fusion implant at least partially within the defective portion.
30. The method of claim 22, wherein the positioning the fusion implant at least partially within the defective portion comprises positioning the fusion implant such that the load member does not bear that portion of the vertical load transmitted from the superior vertebral bone to the inferior vertebral bone and through the fusion implant.
31. The method of claim 22, wherein the fusion implant further comprises a mechanism configured to cause biasing of the load member towards the second position.
32. The method of claim 31, further comprising preloading the load member with a biasing force, the biasing force easing transition of the load member from the first position to the second position.
33. The method of claim 22, wherein the load member comprises a curvilinear configuration, and wherein the transition of the load member from the first position to the second position comprises utilizing at least a portion of the curvilinear configuration.
34. The method of claim 22, wherein the transitioning the load member from the first position to the second position comprises causing the load member to apply a centripetal force onto the bone forming material, the centripetal force being at least partially directed towards a vertical axis of the spinal segment.
35. The method of claim 22, wherein: the fusion implant comprises a non-expandable, rectangular body having the proximal side wall, the distal side wall, a first side wall connecting the proximal side wall and the distal side wall, and a second side wall opposing the first side wall; and the positioning the fusion implant at least partially within the defective portion, such that the upper abutment member of the fusion implant abuts the inferior aspect of the superior vertebral bone and the lower abutment member of the fusion implant abuts the superior aspect of the inferior vertebral bone comprises maintaining a relationship between the first sidewall and second sidewall at least during said positioning.
36. The method of claim 22, wherein the load member is configured to move relative to each of the proximal side wall, the distal side wall, the first side wall and the second side wall, and wherein the transitioning the load member from the first position to the second position comprises causing said movement relative to each of the proximal side wall, the distal side wall, the first side wall and the second side wall.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050]
[0051]
[0052]
[0053]
[0054]
[0055]
DETAILED DESCRIPTION
[0056] Disclosed are methods and devices that are adapted to assist in the fusion of adjacent bones of a skeletal system. The methods and devices are described herein in the context of use in the spine, although the disclosed methods and devices are suitable for use in any skeletal region.
[0057] The device can be, for example, a cage configured to contain bone graft that fuses to one or more adjacent bones of a skeletal system in which the bones are located. The cage also provides structural support to the segment of the skeletal system in which the bones are located. In this regard, the cage bears the structural load that is transmitted through the skeletal segment to at least partially shield the contained bone graft from the structural load. However, the cage is configured to provide a secondary load (separate from the structural load) to the bone graft contained within the cage, wherein the secondary load promotes fusion between the bone graft and adjacent bone of the skeletal system. The secondary load contributes to an advantageous increase in density of the fusion mass that develops as the bony fusion between the bone graft and adjacent bone proceeds. The secondary load is at least partially independent of the structural load transmitted through the skeletal system that the cage supports.
[0058] The cage can also be configured to exert at least a portion of the secondary load to the bones of the skeletal system adjacent the cage. The cage can further be configured so that at least a portion of the structural load is applied to the bone graft contained within the cage. In this regard, for example, the cage can subdivide the structural load by subsidence of adjacent bones and exert the secondary load onto the bone graft contained within the cage. The cage can also be configured to facilitate surface contact between the bone graft within the cage and the neighboring native bone.
[0059]
[0060] The cage 100 includes a main body 105 configured to contain bone graft, at least one load member 110 that provides a load to the contained bone graft, and a hinge 115 (shown in
[0061] With reference to
[0062] The main body 105 defines an interior cavity that is at least partially exposed via one or more holes or openings disposed in the main body 105, such as on its sides, tops, and/or bottoms. The openings permit contact between the vertebral surfaces and the bone graft contained within the main body 105. One of the openings is sized and shaped to receive at least a portion of the load member 110, as described below.
[0063] The main body 105 has an upper region that defines an upper engagement surface 18 that contacts the upper vertebra when the cage is implanted between the vertebrae. The main body 105 further includes a lower region that defines a lower engagement surface 120. The upper and lower engagement surfaces 118, 120 can be flat or can have or regular or irregular-shaped structures thereon, such as having knurled or pyramidal structures as shown in
[0064] A borehole 125 extends through the main body, such as through one of its side walls. The borehole 125 is sized and shaped to receive an insertion member, as described in detail below. The borehole 125 can have internal threads that couple to corresponding threads on the insertion member.
[0065] In the embodiment shown in
[0066] As mentioned, the load member 110 is door-like such that it rotatably moves in and out of the opening in the side of the main body 105. In this regard, the load member 110 is coupled to the main body 105 via the hinge 115, which is positioned in a complementary-shaped slot 128 in the main body 105. A portion of the load member 110 is sized and shaped to mate with the slot 128 such that the hinge 115 rotatably retains the load member to the main body 110.
[0067] The hinge 115 provides a biasing force that biases the load member 110 towards a closed position wherein the load member 110 can apply a load to bone graft contained within the main body 105. The hinge can be made of any suitable material and can have any structure and shape that permits the hinge 115 to provide such a biasing force. In an exemplary embodiment, the hinge 115 is made of a thin titanium band that can serve as a spring for biasing the load member 110 toward the main body. The thin titanium band can also as a radio-opaque marker that can be used to ascertain the cage position on an x-ray.
[0068]
[0069] At least a portion of the load member 110 extends into the internal cavity of the main body 105 for applying a load to at least a portion of the bone graft contained within the main body 105. The load can be applied by direct or indirect contact between at least a portion of the load member 110 and the contained bone graft, as described below.
[0070]
[0071] The cage interface 515 of the insertion member 505 is threaded into the borehole 125 such that the cage interface 515 gradually moves further into the borehole 125. As the cage interface 515 moves further into the borehole 125, the cage interface 515 forces the load member 110 to move from the closed position (shown for example in
[0072] The coupling of the insertion member 505 to the cage 100 and corresponding opening of the load member 110 is described in more detail with reference to
[0073] The cage interface 515 can have a length such that an edge of the cage interface 515 protrudes at least partially into the internal cavity of the main body 105. In this manner, the protruding edge of the cage interface 515 can exert a load on the bone graft that is contained within the internal cavity, as describe further below.
[0074] In use, the insertion member 505 threaded into the main body 105 to cause the load member 110 to move into the open position such that it withdraws from the main body 105 of the cage. The insertion member 505 acts to hold the load member 110 in the open position. Using the insertion member 505 as a handle, an operator then implants the cage 100 in between a pair of vertebrae, such as between an upper vertebra and a lower vertebra. During implantation, an instrument can be advanced into the internal cavity to compact, compress and load the bone graft.
[0075] The internal cavity of the main body 105 is then packed with bone graft. The cavity can be packed with a sufficient volume of bone graft such that the bone graft fills the internal cavity.
[0076] When positioned between the upper and lower vertebrae, the upper surface 118 of the main body 105 abuts or otherwise contacts the upper vertebra. The lower surface 120 abuts or otherwise contacts the lower vertebra. With the cage 100 positioned between the vertebrae, the insertion member 505 is detached from the cage 100.
[0077] With the cage 100 implanted between the vertebrae, the main body 105 of the cage 100 provides structural support for the skeletal segment in which the upper and lower vertebra are positioned. That is, the cage 100 is of sufficient rigidity to bear structural loads that are transmitted through the vertebra. The main body 105 of the cage 110 has sufficient rigidity to shield such structural loads from the bone graft contained within the main body 105.
[0078] Although the main body 105 of the cage 100 shields the contained bone graft from the structural loads, the load member 110 provides a secondary load to the bone graft contained within the cage 100. When the insertion member 505 is detached from the cage 100, the cage interface 515 (shown in
[0079] The bone graft within the cage 100 are pushed inwards in a horizontal plane and towards the upper and lower ends of the cage 100 in a longitudinal plane. The longitudinal component of the force increase the extent of contact between the bone graft and the vertebral surfaces whereas both components apply a constant force onto the graft. Both of these factors act synergistically to maximize the likelihood of bony fusion and optimize the quality of the fusion mass.
[0080] The cage 100 can include holes that extend through the upper and lower ends of the main body 105. When the load member 110 exerts the load against the bone graft contained within the main body, the bone graft can be urged to move upward and/or downward through the upper and lower holes. The force can urge the bone graft upward and downward out of the holes toward the upper and lower vertebra. In this manner, the bone graft is urged into increased surface contact with the neighboring bones. This promotes fusion between the bone graft and the neighboring bones.
[0081]
[0082] The load member 1010 is shown in
[0083] With reference to
[0084]
[0085] The manner in which the load member actuator 1410 moves the load member 1010 from the withdrawn position to the extended position is now described with reference to
[0086] To move the load member 1010 to the extended position, the load member actuator 1410 is pushed toward the load member 1010 such that the distal end 1505 of the actuator 1410 abuts the load member 1010. The load member actuator 1410 pushes the load member 1010 into the extended position, as shown in
[0087] In use, the cage 1000 is positioned between a pair of vertebrae using the insertion member 1405, such as in the manner described above with respect to the previous embodiment. The cage 100 is then packed with bone graft while the load member is in the withdrawn position, as shown in
[0088]
[0089]
[0090] With reference still to
[0091]
[0092] With reference to
[0093]
[0094] The indentations on the upper and lower segments can be similarly-shaped but staggered. The staggered configuration permits two cages 1700 (an upper cage and lower cage) to staked on top of one another such that the pyramidal indentations of the lower end segment of the upper cage compliment the upper end segment of the lower cage. While the individual segments have been separately described, the cage 1700 can be a unitary device that is manufactured as one piece.
[0095]
[0096] The screen 1708 is a planar piece of material that is wrapped around itself in an annular fashion. The screen 1708 has a pair of edges 1915 and 1920 that overlap one another and that can be drawn apart from one another so as to permit a predefined amount of expansion when the interior cavity is packed with bone graft.
[0097] Any of the cages described herein or any of their components can be made of any biologically adaptable or compatible materials. Materials considered acceptable for biological implantation are well known and include, but are not limited to, stainless steel, titanium, tantalum, combination metallic alloys, various plastics, resins, ceramics, biologically absorbable materials and the like. It would be understood by one of ordinary skill in the art that any system component can be made of any materials acceptable for biological implantation and capable of withstanding the load encountered during use. Any components may be further coated/made with osteo-conductive (such as deminerized bone matrix, hydroxyapatite, and the like) and/or osteo-inductive (such as Transforming Growth Factor TGF-B, Platelet-Derived Growth Factor PDGF, Bone-Morphogenic Protein BMP, and the like) bioactive materials that promote bone formation.
[0098] Further, any instrument or device used in implant placement may be made from any non-toxic material capable of withstanding the load encountered during use. Materials used in these instruments need not be limited to those acceptable for implantation, since these devices function to deliver the implantable segments but are not, in themselves, implanted.
[0099]
[0100]
[0101] The interior cavity can be packed with bone graft sufficient to cause the screen 1708 to expand outwardly over the space 2205.
[0102] In the embodiment shown in
[0103]
[0104] Pyramidal indentations or other type of alignment structures are positioned along the upper, oblique surface that is intended to rest against the lower surface of the upper vertebra. Pyramidal indentations are also located along the straight bottom surface and interact with and compliment the indentations on the upper surface of the upper segment 1725.
[0105] A full thickness bore 2425 with a tapered opening extends through the wedge segment 2410 and aligns with the bore 1810 (shown in
[0106]
[0107] The screw 2505 functions to retain the wedge segment 2410 on top of the cage 1700. In this regard, the screw 2505 has an enlarged head 2510 that abuts the upper end of the wedge segment 2410 to retain the wedge segment 2410 in place. The head can include indentation, which is intended to receive an engageable driver. While depicted as a hexagonal indentation, it is understood that any engageable head design and complimentary driver may be used.
[0108]
[0109] While not illustrated, a wedge segment 2410 may be added to the top of the stacked cages so that the end segments of the total device are not parallel. Alternatively, the top surface of the upper device can be made at an inclined angle. The lower surface of the lower device can also made at an inclined angle. In this way, the total (stacked) device can be made with non-parallel upper and lower surfaces.
[0110] In use, a distraction instrument is used to grab the screen 1708 of an empty cage 1700. The openings 1905 (shown in
[0111] The distraction instrument is used to hold and guide the packed cage 1700 into the operative site and properly position it, such as between an upper vertebra and a lower vertebra. At this stage, the radially-inward force exerted by the bias of the screen 1708 is countered by the distraction instrument such that the bone graft does not experience any compressive force from the screen 1708. However, the bone fragments are retained within the cage 1700 by the force used to pack them into the cage 1700.
[0112] Once the cage 1700 is properly positioned between the vertebra, the distraction instrument is released and the same instrument is used to compress the screen edges. In this way, a centripetal, compressive force is applied to the bone graft inside the cage 1700 and the force is maintained by the memory inherent in the material used to manufacture the screen 1708. The applied force will also drive the bone graft within the cage 1700 towards the upper and lower end and increase the contact between the caged bone and the vertebral bone.
[0113]
[0114]
[0115] The cage 2700 is packed with bone graft and implanted between a pair of bones using the insertion member 2905. When the insertion member 2905 is coupled to the cage 2700, the load member 2910 is inserted into the shaft 2015 such that the end of the load member 2910 protrudes out of the insertion member 2905 and into the internal cavity of the cage 2700, as shown in
[0116]
[0117] As shown in
[0118]
[0119] Although embodiments of various methods and devices are described herein in detail with reference to certain versions, it should be appreciated that other versions, embodiments, methods of use, and combinations thereof are also possible. Therefore the spirit and scope of the appended claims should not be limited to the description of the embodiments contained herein.