US20070010886A1 - Skeletal Stabilization Implant - Google Patents

Abstract

A spinal implant is described in this disclosure. The implant includes first and second pieces separated by a controlled break location. Spinal implant kits having multiple spinal implant pieces derived from a common source also are disclosed.

Description

• This application claims priority to U.S.Provisional application 60/325,804, filed Sep. 28, 2001.
FIELD OF THE INVENTION
• The present invention relates generally to skeletal implants. More particularly, the present invention relates to implants for stabilizing intervertebral joints.
BACKGROUND OF THE INVENTION
• Chronic back problems cause pain and disability for a large segment of the population. In many cases, chronic back problems are caused by intervertebral disc disease. When an intervertebral disc is diseased, the vertebrae between which the disc is positioned may be inadequately supported, resulting in persistent pain. Stabilization and/or arthrodesis of the intervertebral joint can reduce the pain and debilitating effects associated with disc disease.
• Spinal stabilization systems and procedures have been developed to stabilize diseased intervertebral joints and, in some cases, to fuse the vertebrae that are adjacent the diseased joint space. Most fusion techniques include removing some or all of the disc material from the affected joint, and stabilizing the joint by inserting an implant (e.g., a bone graft or other material to facilitate fusion of the vertebrae) in the cleaned intervertebral space.
• Spinal implants can be inserted into the intervertebral space through an anterior approach, a posterior approach, or postero-lateral approach. The anterior approach involves a surgeon seeking access to the spine through the front (i.e., abdominal area) of the patient. The posterior approach involves a surgeon seeking access to the spine through the back of the patient. The postero-lateral approach is similar to the posterior approach with access coming more from either or both sides of the patient. A variety of different anterior, posterior and postero-lateral techniques are known.
• It is often an advantage to use the posterior approach because such an approach typically involves a smaller and less intrusive opening than those required by anterior approach techniques. Because a posterior approach involves a smaller opening, two or more implants are often used in this approach as compared to using a single larger implant. For example, in one technique, adjacent vertebral bodies are stabilized by implanting separate implants between the vertebral bodies on opposite sides of a sagittal plane passing through the midline of the vertebral bodies. When using multiple implants to support adjacent vertebrae, it is desirable for the implants to have similar or identical mechanical properties so that uniform support is provided on both sides of the sagittal plane. In some instances, it also is desirable for the implants to have similar or identical biologic properties (e.g., to reduce the risk of tissue rejection and to enhance the uniformity of creeping substitution).
SUMMARY OF THE INVENTION
• One aspect of the present invention relates to skeletal implants and skeletal implant kits adapted to ensure that multiple implants used to support opposing vertebrae have been derived from the same source.
• A variety of other aspects of the invention are set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practicing the invention. The aspects of the invention relate to individual features, as well as combinations of features. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a top, plan view of one embodiment of a spinal implant in accordance with the principles of the present invention;
• FIG. 2ais a front, top perspective view of the spinal implant ofFIG. 1;
• FIG. 2bis a rear, perspective view of the spinal implant ofFIG. 1;
• FIG. 2cis a front view of the spinal implant ofFIG. 1;
• FIG. 2dis a side view of the spinal implant ofFIG. 1;
• FIG. 3 shows the spinal implant ofFIG. 1 split into two pieces;
• FIG. 4 shows one piece of the spinal implant ofFIG. 1;
• FIG. 5ais a cross-sectional view taken along section line5a-5aofFIG. 1;
• FIG. 5bis a cross-sectional view taken along section line5b-5bofFIG. 1;
• FIG. 5cis a cross-sectional view taken along section line5c-5cofFIG. 1;
• FIG. 6a-6eshow various views of an insertion tool suitable for inserting the spinal implant ofFIG. 1;
• FIG. 7 is a kit incorporating the spinal implant ofFIG. 1;
• FIG. 8 is a kit incorporating the spinal implant ofFIG. 1 with the spinal implant being separated into two pieces; and
• FIGS. 9aand9bshow the spinal implant ofFIG. 1 inserted into the intervertebral space between two vertebrae.
DETAILED DESCRIPTION
• The present invention is directed to skeletal implants, skeletal implant kits and methods for placing implants between bones desired to be fused. It is preferred for the implants to be used for vertebral/spinal applications such as fusing cervical, thoracic and/or lumbar intervertebral joints. In the case of fusing an intervertebral joint, implants in accordance with the principles of the present invention can be implanted using an anterior, posterior or postero-lateral approach to the patient's vertebrae.
• As used herein, an “implant” includes any implant suitable for facilitating fusion between adjacent bones and includes implants prepared from known implant materials including, non-bone material such as titanium, stainless steel, porous titanium, bio-glass, calcium phosphate, ceramic, carbon fiber-based polymers, biodegradable and polymers. However, it is preferred for implants in accordance with the principles of the present invention to be derived from natural bone tissue (e.g., allograft and xenograft bone). It is most preferred for implants in accordance with the principles of the present invention to be derived from natural bone such as from a cadaveric allograft bone source. For example, the implants can be derived by cross-sectioning cortical rings from cadaveric allograft bones such as femur, tibia or fibia bones. Alternatively, the implants can be formed/molded from ground, sintered or composite bone material. Bone tissue cut from a human femur bone is particularly suited for use in practicing the principles of the present invention. Xenograft bones (e.g., from a bovine source) also can be used.
• The term “allograft” will be understood to mean a bone implant from a donor transplanted to a genetically dissimilar recipient of the same species. The term “xenograft” will be understood to mean a bone implant from a donor transplanted to a recipient of a different species.
• FIG. 1 shows aspinal implant20 that is an embodiment of the present invention. As shown inFIG. 1, thespinal implant20 includes first andsecond pieces22,24 (i.e., legs). The first andsecond pieces22,24 include portions opposing one another so as to define aninner pocket26. The first andsecond pieces22,24 are integrally connected to one another at acentral connection location28. In one embodiment, theimplant member20 has a reduced cross-sectional area at thecentral connection location28. The reduced cross-sectional area provides a controlled break location at thecentral connection location28. As best shown inFIGS. 5a-5c, the region of reduced cross-sectional area at thecentral connection location28 is smaller than nominal cross-sectional areas (average cross-sectional areas) of each of the first andsecond pieces22,24 of thespinal implant member20.
• As shown inFIG. 1, thespinal implant20 has a generally “C” or “U” shape. Theimplant member20 includes a convexouter boundary30 and aninner boundary32 having aconcave portion33 and opposingstraight portions35. As shown inFIGS. 2aand2c,grooves37 may be cut in thestraight portions35. A fixture fits within thegrooves37 to secure the implant during manufacture of theimplant20. Theinner boundary32 defines thepocket26 of theimplant20.
• Referring again toFIG. 1, afirst notch34 located at theouter boundary30 of theimplant20 defines the reduced cross-sectional area at the controlled break location. Asecond notch36 located at theinner boundary32 of thespinal implant20 also defines the reduced cross-sectional area. Thefirst notch34 is preferably larger than thesecond notch36. Bothnotches34 and36 are aligned along an axis ofsymmetry38 of thespinal implant20.
• Preferably, the controlled break location is configured to allow the first andsecond pieces22,24 of theimplant member20 to be manually broken or “snapped” apart without requiring the use of a tool. The controlled break structure ensures that theimplant20 will break at a predetermined location (e.g., at the axis ofsymmetry38 for the embodiment ofFIG. 1). Theimplant member20 can be snapped by manually pulling thepieces22,24 apart by applying forces shown byarrows25. Alternatively, theimplant20 can be snapped by manually pressing the pieces together as shown byarrows27. Further, theimplant member20 can be broken by manually impacting the controlled break location against a relatively hard surface or edge such as the edge of a surgical instrument tray. In one embodiment, the reduced cross-sectional area provided at the controlled break location is at most 75 percent or, more preferably, about 50 percent of the nominal cross-sectional areas of each of the first andsecond pieces22,24. The controlled break locations can be defined by a variety of techniques for generating a “weaker” region at a desired location. Such weakened region can be formed by techniques such as notching, scoring, etching, cutting, mechanically perforating, laser perforating, etc. Alternatively, the controlled break location can be “weakened” by altering the mechanical properties of the implant material at the controlled break location by techniques such as radiation, demineralization or other techniques.
• FIG. 3 shows thespinal implant20 after the implant has been manually “snapped” at the controlled break location. While it is preferred for thespinal implant20 to be manually broken, it will be appreciated that tools such as forceps, knives, scissors, saws, clamps or other devices could also be used to split theimplant20 into multiple separate pieces. Further, impact tools such as hammers, chisels or the like also could be used. If tools are desired to be used, a controlled break location may, but need not, be provided. Instead, a line or other demarcation can be used to define a predetermined break location that provides a guide for using the tool.
• Although the embodiment ofFIG. 1 shows the controlled break location located at the central axis of symmetry of theimplant20, it will be appreciated that other embodiments can include controlled break locations offset from the center of the implant. Further, multiple controlled break locations can be provided to allow the implant to be broken into more than two pieces. Further, in another embodiment, an entire cortical ring is provided having two oppositely positioned break locations for allowing the implant to be snapped in half to form two separate implants.
• Referring again toFIG. 1, thefirst notch34 is defined by first and second insertion force application surfaces40,42 aligned at an oblique angle relative to one another. The insertion force application surfaces40,42 are preferably aligned parallel togrooves44 formed in top and bottom surfaces of thespinal implant20. During implantation of the first andsecond pieces22,24, pins of an insertion tool (e.g., seeinsertion tool52 ofFIGS. 6a-6e) are placed in openings45 (shown inFIGS. 2band6e) defined in the insertion force application surfaces40,42. During insertion, insertion forces are applied to thesurfaces40,42 via thetool52 to individually push thepieces22,24 into the intervertebral space. Particularly for posterior approach techniques, it is desirable for thepieces22,24 to be inserted in a direction requiring the smallest possible opening to be defined through the patient's posterior region. For example,arrow46 ofFIG. 4 shows a preferred direction of insertion. It is preferred for the insertion force surfaces40,42 to be perpendicularly aligned relative to the preferred insertion directions of theircorresponding pieces22,24.
• Thegrooves44 of theimplant20 function to resist migration of the implant upon implantation between opposing bone surfaces. Other structures such as teeth, serrations, cross-cut serrations, notches, bumps, ridges, projections or other surface treatments could also be used.
• While theimplant20 can have a constant thickness, it is preferred for theimplant20 to be slightly tapered. In one embodiment, thespinal implant20 can be tapered about 3 degrees such that afront end48 of theimplant20 has a thickness T_fthat is greater than a thickness T_rlocated at arear end50 of theimplant20. The thicknesses T_fand T_rare labeled inFIG. 2d. In another embodiment, thefront end48 of theimplant20 may be chamfered to facilitate insertion.
• FIGS. 6a-6eshow aninsertion tool52 suitable for individually implanting the first andsecond pieces22,24 of thespinal implant20 into the intervertebral space of a patient. Theinsertion tool52 includes aninsertion end55 having twoparallel pins57 adapted to fit within theopenings45 defined by the force application surfaces40,42 of theimplant pieces22,24. Thetool52 also includes acurved retaining surface59 adapted to contact and complement a portion of theouter boundary30 of theimplant piece22,24 when theimplant piece22,24 is mounted at theinsertion end55.
• While other materials could be used, thespinal implant20 is preferably derived from an allograft bone. In one embodiment, theimplant20 is a transverse cross-section from the femur of a cadaver, and includes a cortical ring. After the ring has been cross-sectioned, relatively soft bone tissue and marrow from the interior of the ring is preferably removed. Next, a portion of the outer cortical ring is removed (e.g., by a technique such as mechanically cutting with a blade or abrasion tool, laser cutting, etching, etc.) to provide the open end of thepocket26 of the “C” shaped implant20 (seeFIG. 1). Bone removal techniques are then also used to shape the outer andinner boundaries30,32 and to form thenotches34,36. While the particular shape depicted inFIG. 1 is preferred, it will be appreciated that other shapes also could be used without departing from the principles of the present invention.
• FIG. 7 illustrates akit60 that is an embodiment of the present invention. The kit includes thespinal implant20, theinsertion tool52 and instructions of use. The components are contained within a sterile package66 (e.g., a bag, plastic container or other sealed holding configuration). In other embodiments, the kit includes thespinal implant20, alone, within the sterile package.
• FIG. 8 shows anotherkit60′ that is an embodiment of the present invention. Similar to the embodiment ofFIG. 7, thekit60′ includes thespinal implant20, theinsertion tool52 and the instructions ofuse64. Also similar to the embodiment ofFIG. 7, the various parts are held within asterile package66. However, in the embodiment ofFIG. 8, thespinal implant20 has been pre-broken into the first andsecond pieces22,24. Preferably, both the first andsecond pieces22,24 were derived from the same source. For example, preferably the first andsecond pieces22,24 were provided from human bone tissue from the same cadaver. More preferably, thepieces22,24 were provided from the same cortical ring of the same bone. By packaging two or more implant pieces from the same source in one package, the surgeon that ultimately uses the implants will be assured that the pieces will exhibit similar or identical mechanical and biological properties. Further, by using bone pieces from the same donor, the risk of transferring disease to the patient is reduced by50 percent as compared to using bone samples from two different donors. In other embodiments, thekit60′ includes the first andsecond pieces22,24, alone, within the sterile package.
• The configuration of the implant ofFIG. 1 provides similar advantages. For example, because the first andsecond implant pieces22,24 can be provided to a surgeon in an integrally connected configuration, the surgeon can be assured that the two pieces were derived from the same bone source. Further, the configuration of the controlled break location allows the surgeon to quickly and easily separate the two pieces without requiring a tool. In the event the implant is made of a non-bone material, the configuration ensures the surgeon that theimplant pieces22,24 were manufactured in the same lot.
• To implant thespinal implant20, a diseased disc between twoadjacent vertebrae72,74 is preferably removed using a conventional discectomy procedure (i.e., partial or complete discectomy). Opposingend plates72′ and74′ of thevertebrae72,74 are then preferably prepared to provide relatively flat contact surfaces. Theend plates72′,74′ are then conditioned (e.g., with a rasp) to provide a more uniform and osteoconductive/osteoinductive site for theimplant20. After the implant site has been prepared, the sterile package of thekit60 is opened, allowing the surgeon to access theimplant20. Preferably, theimplant20 is then manually “snapped” or broken into two pieces. One of thepieces22 is then placed on theinsertion tool52. With the insertion tool, the surgeon inserts thefirst piece22 into the cleared intervertebral space between thevertebrae72,74. Preferably, thefirst piece22 is inserted using a posterior approach. As thefirst piece22 is inserted, an insertion force is transferred through theinsertion tool52 to theinsertion force surface40 of thefirst implant piece22. As shown inFIGS. 9aand9b, thefirst implant piece22 is preferably positioned on one side of asagittal plane80 that passes through the midline of thevertebrae72,74. Once thefirst implant piece22 has been inserted, thetool52 is withdrawn from theimplant piece22 and thesecond implant piece24 is preferably inserted using the same procedure. However, thesecond implant piece24 is preferably positioned on the opposite side of thesagittal plane80. As mounted in the intervertebral space, thefront end48 of theimplant20 is preferably located at an anterior position relative to therear end50. To further promote fusion, additional bone material (e.g., cancellous allograft or autograft material) or other osteoconductive/osteoinductive material can be placed in the intervertebral space corresponding to theinner pocket26 of theimplant20. This material can be placed in the intevertebral space before insertion of thefirst implant piece22, after insertion of thefirst implant piece22, but before insertion of thesecond piece24, and/or after both implantpieces22,24 have been implanted.
• It will be appreciated that thekit60′ can be used in essentially the same manner as thekit60, except thekit60′ does not require the surgeon to manually break thespinal implant20 into the separate first andsecond pieces22,24. In both embodiments, the surgeon can be assured that both the first andsecond pieces22,24 of thespinal implant20 were derived from the same donor source.
• With regard to the foregoing description, it is to be understood that changes may be made in detail without departing from the scope of the present invention. It is intended that the specification and depicted aspects of the invention may be considered exemplary, only, with a true scope and spirit of the invention being indicated by the broad meaning of the following claims.

Claims (33)

1-25. (canceled)

26. A method of manufacturing a skeletal implant, the method comprising:

isolating a segment of bone; and

forming a controlled break location in the segment of bone.

27. The method ofclaim 26, wherein the bone is from an allograft bone source.

28. The method ofclaim 26, wherein the controlled break location is formed by forming a notch in the segment of bone.

29. A method of manufacturing a skeletal implant, the method comprising:

isolating a segment of bone having first and second opposite pieces; and

forming a controlled break location in the segment of bone positioned between the first and second pieces.

30. The method ofclaim 29 wherein isolating the segment of bone involves forming a convex outer boundary and a concave inner boundary, wherein forming the controlled break location involves forming a first notch at the outer boundary.

31. The method ofclaim 30, wherein forming the controlled break location further involves forming a second notch at the inner boundary.

32. A skeletal implant kit comprising:

a first implant derived from a bone source;

a second implant derived from the same bone source as the first implant; and

a package containing the first and second implants.

33. The implant kit ofclaim 32, wherein the bone source is a cadaveric femur bone.

34. The implant kit ofclaim 32, wherein the first and second implants are substantially the same size and shape.

35. A skeletal implant kit comprising:

a unitary implant breakable into a plurality of pieces, the implant being derived from a bone source;

a package containing the unitary implant.

36. The skeletal implant kit ofclaim 35, wherein the unitary implant is manually breakable.

37. The skeletal implant kit ofclaim 35, wherein the unitary implant is breakable into first and second pieces.

38. The skeletal implant kit ofclaim 35, wherein the pieces are substantially the same size and shape.

39. The skeletal implant kit ofclaim 35, wherein the bone source is a cadaveric femur bone.

40. A method for stabilizing bone surfaces, the method comprising:

inserting a first implant between the bone surfaces, the first implant comprising a first portion of a bone source; and

inserting a second implant between the bone surfaces, the second implant comprising a second portion from the bone source.

41. The method ofclaim 40, wherein the bone source is from a human donor.

42. The method ofclaim 40, wherein the bone source is a femur bone.

43. The method ofclaim 40, wherein the bone source includes an allograft bone source.

44. The method ofclaim 40, wherein the first and second implants are inserted from a posterior approach.

45. The method ofclaim 40, wherein the first and second implants are derived from a unitary implant.

46. A method for stabilizing two vertebrae, the method comprising:

separating a one-piece implant into at least two implant pieces;

inserting a first one of the implant pieces between the two vertebrae; and

inserting a second one of the implant pieces between the two vertebrae.

47. The method ofclaim 46, wherein the first and second implant pieces are inserted from a posterior approach.

48. The method ofclaim 46, further comprising obtaining the one-piece implant from a sterile package before separating the one-piece implant into the first and second implant pieces.

49. The method ofclaim 46, wherein the one-piece implant is separated into the first and second pieces by manually breaking the one-piece implant.

50. The method ofclaim 49, wherein the one-piece implant is broken at a predefined break location.

51. The method ofclaim 46, wherein the one-piece implant is separated into the first and second pieces by cutting the one-piece implant with a tool.

52. The method ofclaim 46, wherein the one-piece implant is from an allograft bone source.

53. A skeletal implant comprising:

a first implant portion;

a second implant portion; and

a third portion joining, and integral with, the first and second implant portions and having a breakable location,

the first and second implant portions being adapted to be independently implantable into a patient after the third portion is broken at the breakable location, each of the first and second implant portions comprising a mounting structure adapted to engage an insertion tool for implanting the portion, wherein the mounting structure comprises a force-application surface and an opening defined through the surface, the opening adapted to receive a protrusion on the insertion tool.

54. The implant ofclaim 53, wherein each of the first and second implant portions has an upper surface adapted to engage a first vertebra in the patient and a lower surface adapted to engage a second vertebra in the patient.

55. The implant ofclaim 54, wherein the opening is an elongated channel along a longitudinal axis, and the force-application surface is substantially perpendicular to the longitudinal axis.

56. A skeletal implant comprising:

first and second implant members, each comprising:

a top surface adapted to engage and support an upper vertebra, and

a bottom surface adapted to engage and support a lower vertebra; and

a single controlled break location positioned between the first and second implant members, the controlled break location including a region of reduced cross-sectional area, the region of reduced cross-sectional area being smaller than nominal cross-sectional areas of each of the first and second implant members, wherein the first and second implant members are symmetrically disposed with respect an axis of symmetry passing through the controlled break location.

57. A skeletal implant comprising:

first and second implant members, each comprising:

a top surface adapted to engage and support an upper vertebra, and

a bottom surface adapted to engage and support a lower vertebra; and

a single controlled break location positioned between the first and second implant members, the controlled break location including a region of reduced cross-sectional area, the region of reduced cross-sectional area being smaller than nominal cross-sectional areas of each of the first and second implant members, wherein the skeletal implant member is C-shaped.

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