Anterior lumbar cage and inserter device
11576785 ยท 2023-02-14
Assignee
Inventors
Cpc classification
A61F2002/30787
HUMAN NECESSITIES
A61F2002/4627
HUMAN NECESSITIES
A61F2002/2835
HUMAN NECESSITIES
A61F2002/30331
HUMAN NECESSITIES
A61F2/30749
HUMAN NECESSITIES
A61F2/447
HUMAN NECESSITIES
A61F2002/30579
HUMAN NECESSITIES
A61F2/30734
HUMAN NECESSITIES
A61F2002/30383
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2002/30841
HUMAN NECESSITIES
A61F2002/30795
HUMAN NECESSITIES
A61F2002/4629
HUMAN NECESSITIES
A61F2002/30131
HUMAN NECESSITIES
A61F2310/00796
HUMAN NECESSITIES
A61F2002/4687
HUMAN NECESSITIES
International classification
Abstract
A plate and cage assembly for stabilization of vertebral bodies. The assembly includes at least one fixation member, a cage having a proximal wall, a superior surface and an inferior surface (the superior surface and the inferior surface for engaging adjacent vertebrae), and a plate coupled to the cage and having at least one hole traversing the plate at an angle for insertion of the at least one fixation member into one of the vertebral bodies. The proximal wall of the cage has a blind hole, and the plate has a threaded screw hole aligned with the blind hole in the proximal wall of the cage.
Claims
1. A plate and cage assembly for stabilization of vertebral bodies, comprising: at least one bone fastener; a cage having a proximal wall, a distal wall, opposing sidewalls, a superior surface and an inferior surface, the superior surface and the inferior surface for respectively engaging adjacent vertebral bodies; and a plate coupled to the cage at the proximal wall, the plate having at least one hole traversing the plate at an angle for insertion of the at least one bone fastener into one of the vertebral bodies, and comprising a retention member for preventing the at least one bone fastener from backing out from the one of the vertebral bodies; wherein: the proximal wall of the cage comprises a blind hole for engaging with a tip portion of an insertion device and at least one opening for engaging the at least one bone fastener, the plate has a threaded alignment hole aligned with the blind hole in the proximal wall of the cage when the plate and the cage are coupled, the threaded alignment hole configured to engage with and couple to a threaded portion of the insertion device, the cage and the plate comprise respectively an engagement channel and an engagement flange, and the engagement channel of the cage is disposed on a proximal side of the cage adjacent the plate and is open to the superior surface such that the cage and the plate are secured together by sliding the engagement flange of the plate a) toward the inferior surface and b) into the engagement channel on the proximal side of the cage.
2. The assembly of claim 1, wherein, to further secure the engagement channel of the cage and the engagement flange of the plate from separation, a retention arm of the insertion device comprising the tip portion and the threaded portion is configured to extends through the threaded alignment hole in the plate and into the blind hole of the cage.
3. The assembly of claim 1, further comprising corrugations on at least one of the superior surface and the inferior surface of the cage.
4. The assembly of claim 1, wherein the least one bone fastener comprises a curved bone fastener.
5. The assembly of claim 4, wherein each curved bone fastener comprises a proximal end and a distal end having a tapered bone piercing element.
6. The assembly of claim 5, wherein each curved bone fastener further comprises corrugations disposed on exterior sidewalls of the curved bone fastener, the exterior sidewalls separated from each other by a channel extending along a length of the curved bone fastener.
7. The assembly of claim 6, wherein each tapered bone piercing element comprises a first tapered section and a second tapered section, the first tapered section extending from the corrugations to the second tapered section; the second tapered section extending from the first tapered section to a tip of the first tapered section.
8. The assembly of claim 5, wherein each curved bone fastener further comprises a rim at the proximal end for stopping against the at least one hole of the plate when the curved bone fastener is driven into one of the adjacent vertebral bodies.
9. The assembly of claim 5, wherein each curved bone fastener further comprises a threaded hole in the proximal end for removal of the curved bone fastener from one of the adjacent vertebral bodies.
10. The assembly of claim 1, wherein the threaded alignment hole and the blind hole lie on a common axis.
11. The assembly of claim 1, wherein the engagement flange of the plate is a downwardly-extending flange which matingly fits into the engagement channel of the cage.
12. The assembly of claim 11, wherein the engagement channel on the proximal side of the cage extends partially along a height of the cage.
13. An insertion device for inserting the plate and cage assembly between adjacent vertebral bodies, wherein the plate and cage assembly comprises: at least one bone fastener; a cage having a proximal wall, a distal wall, opposing sidewalls, a superior surface and an inferior surface, the superior surface and the inferior surface for respectively engaging adjacent vertebral bodies; and a plate coupled to the cage at the proximal wall, the plate having at least one hole traversing the plate at an angle for insertion of the at least one bone fastener into one of the vertebral bodies, and comprising a retention member for preventing the at least one bone fastener from backing out from the one of the vertebral bodies; wherein: the proximal wall of the cage comprises a blind hole for engaging with a tip portion of the insertion device and at least one opening for engaging the at least one bone fastener, the plate has a threaded alignment hole aligned with the blind hole in the proximal wall of the cage when the plate and the cage are coupled, the threaded alignment hole configured to engage with and couple to a threaded portion of the insertion device, the cage and the plate comprise respectively an engagement channel and an engagement flange, and the engagement channel of the cage is disposed on a proximal side of the cage adjacent the plate and is open to the superior surface such that the cage and the plate are secured together by sliding the engagement flange of the plate a) toward the inferior surface and b) into the engagement channel on the proximal side of the cage; and wherein the insertion device comprises: at least one retention arm for removably coupling to the plate and the cage; a carriage for holding the at least one bone fastener by at least one clip having two opposing resilient arms and two opposing clasps attached respectively to the two opposing resilient arms, wherein, a clip of the at least one clip is configured to slides over a body of one of the at least one bone fasteners such that the two opposing resilient arms spread apart as the two opposing clasps engage the body of the respective bone fastener, and once the two opposing clasps are beyond the body of the bone fastener, the resilient arms return inwardly toward each other to grasp the body of the bone fastener; a handle for holding the insertion device; push rods for pushing the at least one bone fastener through the carriage, through the plate and cage assembly, and in between the adjacent vertebral bodies; a bracket coupled to the push rods; and a push pin for driving the bracket.
14. The insertion device of claim 13, wherein the at least one retention arm comprises a first retention arm and a second retention arm for engaging opposite sides of the plate and cage assembly.
15. The insertion device of claim 13, wherein the at least one retention arm comprises a) the threaded portion for threading into the threaded alignment hole in the plate of the plate and cage assembly, and b) the tip portion for insertion into the blind hole in the cage of the plate and cage assembly.
16. The insertion device of claim 13, wherein the push rods comprise three rods arranged to push a) two superior bone fasteners of the at least one bone fastener and b) an inferior bone fastener of the at least one bone fastener into the adjacent vertebral bodies simultaneously.
17. The insertion device of claim 16, wherein at least one of the two superior bone fasteners and the inferior bone fastener comprises a curved fastener configured to be held by the clip of the at least one clip.
18. The insertion device of claim 17, wherein at least one of the three push rods comprises a straight push rod for pushing the curved fastener out of the carriage.
19. The insertion device of claim 18, wherein the straight push rod is configured to contact firstly a top edge of a proximal end of the curved fastener, and thereafter, as the curved fastener is advanced, the straight push rod progressively contacts lower edges of the proximal end of the curved fastener.
20. The insertion device of claim 16, wherein the bracket comprises a slidable block for pushing the two superior bone fasteners and the inferior bone fastener.
21. A method for stabilization of vertebral bodies, comprising: attaching the insertion device of claim 13 to the plate and cage assembly of claim 1 by way of the at least one retention arm which penetrates through the threaded alignment hole of the plate and inserts in the blind hole in the proximal wall of the cage; inserting the plate and cage assembly of claim 1 into an intervertebral space between two adjacent vertebral bodies; holding the at least one bone fastener in the carriage of the insertion device by way of the at least one clip holding the at least one bone fastener in place prior to insertion between the two adjacent vertebral bodies; advancing and securing each of the bone fasteners into a respective one of the adjacent vertebral bodies; and detaching the insertion device of claim 13 from the plate and cage assembly of claim 1.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawing, wherein:
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DETAILED DESCRIPTION OF THE INVENTION
(10) Embodiments of the disclosure are generally directed to intervertebral implant devices. One or more fixation members, such as screws, nails, shims, tangs, spikes, staples, pins, fins, blades, or the like, may be used to secure the implant devices to adjacent vertebrae. The fixation members may also include a combination of these to provide for optimal ease of insertion and fixation of the device. The intervertebral implant devices may be included with an inserter for placing the implant devices into the intervertebral space and securing the implant devices to the vertebrae with the fixation members.
(11) The embodiments of the disclosure and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments and examples that are described and/or illustrated in the accompanying drawings and detailed in the following description. The features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the disclosure may be practiced and to further enable those of skill in the art to practice the embodiments of the disclosure. Accordingly, the examples and embodiments herein should not be construed as limiting the scope of the disclosure. Moreover, it is noted that like reference numerals represent similar parts throughout the several views of the drawings.
(12) Terms such as distal and proximal are used herein to designate the relative positions of components in relation to a particular view of the object designated, with proximal representing a part of the object closer and distal representing a part of the object farther removed from the proximal. These terms are used for clarity in description, but the examples and embodiments herein should not be construed to mean that the invention does not cover the same objects when viewed from a different perspective. Furthermore, in some cases (but not all), these terms may, be synonymous with human body reference terms anterior and posterior.
(13) In one embodiment of the present invention, there is provided a plate and cage assembly for stabilization of vertebral bodies, comprising: at least one fixation member; a cage having a proximal wall, a superior surface and an inferior surface, the superior surface and the inferior surface for engaging adjacent vertebrae; a plate coupled to the cage and having at least one hole traversing the plate at an angle for insertion of the at least one fixation member into one of the vertebral bodies, wherein the proximal wall of the cage comprises a blind hole, and the plate has a threaded screw hole aligned with the blind hole in the proximal r wall of the cage. The at least one fixation member can include nails, shims, pins, screws, etc.
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(15) In one embodiment of the present invention, cage 6 and plate 4 have complementary engagement structures 6e and 4a which couple the cage and plate together. Engagement structure 6e (in one example) is a vertically-rising engagement channel. This vertically-rising engagement channel in one embodiment does not extend all the way from the superior surface 6a to the inferior surface 6b, and instead a landing 6f is disposed at an intermediate position between the superior surface 6a to the inferior surface 6b. Engagement structure 4a (in one example) is a downwardly-extending flange 4a-1 which fits into the engagement channel 6e-1 of engagement structure 6e (as illustrated in
(16) In one embodiment of the present invention, cage 6 has openings 6g in a proximal wall 6h of cage 6. Accordingly, cage 6 has a distal wall 6j (shown in
(17) In one embodiment of the present invention, plate 4 includes a retention tab 4c which is rotatable such that, once a fastening member is inserted into a vertebra, rotation of tab 4c prevents the fastening member from backing out from the vertebra. In one embodiment of the present invention, plate 4 includes at least two threaded screw holes 4d which can engage a threaded rod of an insertion tool (discussed below). In one embodiment of the present invention, the position of the screw holes 4d on plate 4 align with blind holes 6i above landings 6f. To be discussed in more detail later, a tip of the threaded rod of the insertion tool fits into one of the blind holes 6i such that, once in place, plate 4 and cage 6 cannot translate along the vertically-rising engagement channel of engagement structure 6e.
(18) In one embodiment of the present invention, the implant devices disclosed herein are designed as an anterior lumbar interbody fusion ALIF implant product for implantation into an intervertebral space between vertebral bodies of a spine.
(19) With minor changes to the size and shape of the plate and cage assembly, these implant device can be used in following spinal surgeries for anterior cervical interbody fusion, ACIF and lateral lumbar interbody fusion, LLIF (also know as DLIF and XLIF).
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(23) In one embodiment of the present invention, three curved fastener members 20 (such as shown in
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(26) As shown in
(27) As detailed above and as shown in
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(29) In one embodiment of the invention, there is provided a system for stabilization of vertebrae. This system the implant(s) described above (for example the plate and cage assembly 2) and the insertion device described above, Typically, bone graft would be packed into to the window 6d-1 in the plate and cage assembly 2 prior to insertion between vertebrae. For example, bone graft may be inserted into the plate and cage assembly 2 through window 6d-1 after the plate and cage assembly 2 is attached to the insertion device 40.
(30) In one embodiment, there is provided a method for stabilization of vertebrae.
(31) At 803, insert the plate and cage assembly into an intervertebral space between adjacent vertebrae.
(32) At 805, hold (curved) fastener members in a carriage of the insertion device by way of clips holding the fastener members in place prior to insertion between adjacent vertebrae.
(33) At 807, secure the (curved) fastener members into the adjacent vertebrae and detach and remove the insertion device from the plate and cage assembly.
(34) This invention is not limited to a specific type of bone graft material. In general, a variety of bone graft materials are known and suitable for this invention. These typically comprise calcium phosphate-based or gel-based materials. Polymer-based bone graft substitutes containing (or not containing) collagen can be used. Ceramic bone graft substitutes can be used. In one embodiment, the implantable bone graft material comprises a composite of a ceramic and a polymer. The ceramic and the polymer can be present at a weight ratio ranging from about 10:1 ceramic to polymer to about 2:1 ceramic to polymer. Alternatively, the weight ratio of the ceramic to the polymer can range from about 2:1 (about 66% ceramic to about 33% polymer), from about 3:1 (about 75% ceramic to about 25% polymer), from about 4:1 (about 80% ceramic to about 20% polymer), from about 9:1 (about 90% ceramic to about 10% polymer), from about 10:1 (about 99% ceramic to about 1% polymer). Other bone graft materials besides those specifically listed above can be used.
(35) This invention is also not limited to the type of material that the implant device is made of. The implant devices of the present invention can be made of any material appropriate for human implantation and having the mechanical properties sufficient to be utilized for the intended purpose of spinal fusion, including various metals such as cobalt chrome, stainless steel or titanium including its alloys, various plastics including those which are bio-absorbable, and various ceramics or combination sufficient for the intended purpose. Further, the implants of this invention may be made of a solid material, a mesh-like material, a porous material and may comprise, wholly or in part, materials capable of directly participating in the spinal fusion process, or be loaded with, composed of, treated of coated with chemical substances such as bone, morphogenic proteins, hydroxyapatite in any of its forms, and osteogenic proteins, to make them bioactive for the purpose of stimulating spinal fusion. The implants of this invention may be wholly or in part bioabsorbable. Other materials for the implant device besides those specifically listed above can be used.
(36) This invention is also not limited to the methods by which the implant devices are made. The individual components can be machined from solid stock pieces. Molding can be used to make the individual components. In this case, machining to final dimensions may or may not be in order. The surfaces once properly dimensioned can be coated with a variety of biocompatible coatings and/or surface treatments. Various coatings include for example calcium phosphate ceramics, such as tricalcium phosphate (TCP) and hydroxyapatite (HA), and hydroxyapatite (a naturally occurring material in bone). Moreover, surfaces of the implant device that contact bone may be treated to promote fusion of the implant to the bone. Treatment may include, but is not limited to, applying a hydroxyapatite coating on contact surfaces, spraying a titanium plasma on contact surfaces, and/or texturing the contact surfaces by scoring, peening, implanting particles in the surfaces, or otherwise roughening the surfaces of the implant.
(37) In some embodiments, any of the implants and insertion devices described above can be used with additional implants and instruments. In some embodiments, the implants and instruments can be used with stabilization members, such as plates, screws, and rods. In addition, a multi-level construct can be formed, wherein any one or more of the implant devices described above can be used on one level, while a similar or different implant (e.g., fusion or prosthetic) can be used on a different level.
STATEMENTS OF THE INVENTION
(38) The following are non-limiting statements of the invention describing various aspects of the invention.
(39) Statement 1. A plate and cage assembly for stabilization of vertebral bodies, comprising:
(40) at least one fixation member;
(41) a cage having a proximal wall, a superior surface and an inferior surface, the superior surface and the inferior surface for engaging adjacent vertebrae; and
(42) a plate coupled to the cage and having at least one hole traversing the plate at an angle for insertion of the at least one fixation member into one of the vertebral bodies, wherein
(43) the proximal wall of the cage comprises a blind hole,
(44) the plate has a threaded screw hole aligned with the blind hole in the proximal wall of the cage.
(45) Statement 2. The assembly of statement 1, wherein the cage and the plate comprise respectively an engagement channel and an engagement flange for securing the cage and the plate together.
(46) Statement 3. The assembly of any of the statements above, wherein, to further secure the engagement channel and the engagement flange from separation, a retention arm extends through the threaded screw hole in the plate and into the blind hole of the cage.
(47) Statement 4. The assembly of any of the statements above, further comprising corrugations on at least one of the superior surface and the inferior surface of the cage.
(48) Statement 5. The assembly of any of the statements above, wherein the least one fixation member comprises a curved fixation member.
(49) Statement 6. The assembly of any of the statements above, wherein the curved fixation member comprises:
(50) a proximal end and a distal end having a tapered bone piercing element.
(51) Statement 7. The assembly of any of the statements above, wherein the curved fixation member comprises corrugations disposed on exterior sidewalls of the curved fixation member, the exterior sidewalls separated from each other by a channel extending along a length of the curved fixation member.
(52) Statement 8. The assembly of any of the statements above, wherein
(53) the tapered bone piercing element comprises a first tapered section and a second tapered section,
(54) the first tapered section extending from the corrugations to the second tapered section;
(55) the second tapered section extending from the first tapered section to a tip of the first tapered section.
(56) Statement 9, The assembly of any of the statements above, wherein the curved fixation member comprises:
(57) a rim at the proximal end for stopping against the at least one hole of the plate when the fixation member is driven into a vertebra.
(58) Statement 10, The assembly of any of the statements above, wherein the curved fixation member comprises:
(59) a threaded hole in the proximal end for attached to the curved fixation member for removal from a vertebra.
(60) Statement 11. An insertion device for insertion of a plate and cage assembly between vertebral bodies (including but not limited to any of the plate and cage assemblies set forth in statements 1-10), comprising:
(61) a carriage for holding at least one fixation member by at least one clip having two opposing resilient arms and two opposing clasps attached respectively to the two opposing resilient arms,
(62) wherein, when a clip of the at least one clip slides over a body of a fixation member of the at least one fixation member, the resilient arms spread apart as the clasps engage the body of the fixation member, and once the clasps are beyond the body of the fixation member, the resilient arms return inwardly toward each other to grasp the body of fixation member;
(63) a handle for holding the insertion device;
(64) push rods for pushing the at least one fixation member through the carriage, through the plate and cage assembly, and into the vertebral bodies;
(65) a bracket coupled to the push rods; and
(66) a push pin for driving the bracket.
(67) Statement 12. The insertion device of statement 11, further comprising a retention arm for coupling the carriage to the plate and cage assembly.
(68) Statement 13. The insertion device of statements 11 or 12, wherein the retention arm comprises a) a threaded section for threading into a threaded hole in the plate of the plate and cage assembly and b) a tip for insertion into a blind hole in a cage of the plate and cage assembly.
(69) Statement 14. The insertion device of any of statements 11-13, wherein
(70) the cage attached to the insertion device has a proximal wall, a superior surface and an inferior surface, the superior surface and the inferior surface for engaging adjacent vertebrae;
(71) the plate attached to the insertion device is coupled to the cage and has at least one hole traversing the plate at an angle for insertion of the at least one fixation member into one of the vertebral bodies.
(72) Statement 15. The insertion device of, wherein the push rods comprise three rods arranged to push a) two superior fasteners of any of statements 11-14 the at least one fixation member and b) an inferior fastener of the at least one fixation member into the vertebral bodies simultaneously.
(73) Statement 16, The insertion device of any of statements 11-15, wherein the bracket comprises a slidable block for pushing the superior fasteners and the inferior fastener.
(74) Statement 17. The insertion device of any of statements 11-16, wherein at least one of the superior fasteners and the interior fastener comprises a curved fastener held by the clip.
(75) Statement 18. The insertion device of any of statements 11-17, wherein at least one of the push rods comprises a straight push rod which pushes the curved fastener out of the carriage.
(76) Statement 19. The insertion device of any of statements 11-18, wherein pushing the curved fastener out of the carriage occurs with the straight push rod contacting firstly a top edge of a proximal end of the curved fastener and thereafter, as the curved fastener is advanced, the straight push rod progressively contacts lower edges of the proximal end of the curved fastener.
(77) Statement 20. The insertion device of any of statements 11-19, wherein the push pin is hammered to drive simultaneously multiple of the at least one fixation members into the vertebral bodies.
(78) Statement 21. A method for stabilization of vertebrae, comprising:
(79) attaching an insertion device (including but not limited to any of the insertion devices set forth in statements 11-20) to a plate and cage assembly (including but not limited to any of the plate and cage assemblies set forth in statements 1-10) by way of a retention arm which penetrates past a plate and inserts in a blind hole in a proximal wall of a cage;
(80) inserting the plate and cage assembly into an intervertebral space between adjacent vertebrae;
(81) holding fastener members in a carriage of the insertion device by way of clips holding the fastener members in place prior to insertion between adjacent vertebrae;
(82) securing the fastener members into the adjacent vertebrae; and
(83) detaching the insertion device from the plate and cage assembly.
(84) Numerous modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described herein.