Claims

What is claimed is:

1. A method for inserting at least one frusto-conical spinal fusion implant made of a material appropriate for human implantation, said implant having bone engaging means forengaging the adjacent vertebrae in a segment of the spinal column, comprising the steps of:

distracting said adjacent vertebrae and placing said adjacent vertebrae in an angular relationship;

forming a frusto-conical bore from the anterior or posterior aspect of the spinal column across the distracted disc space between said adjacent vertebrae and into the adjacent vertebrae, said bore being at least in part greater in diameter thanthe distracted disc space such that some bone is removed from each of the adjacent vertebrae; and

inserting a frusto-conical spinal fusion implant into said bore.

2. The method of claim 1 in which said bore is greatest in diameter anteriorly and tapering to a lesser diameter posteriorly.

3. The method of claim 1 in which said bore is substantially cylindrical.

4. The method of claim 1 in which said step of forming includes the steps of using a drill having a substantially frusto-conical shaped bone removing portion.

5. The method of claim 1 further comprising the step of inserting a second spinal fusion implant across the disc space so as to engage each of the adjacent vertebrae, said second implant being side by side and adjacent to said first implant.

6. The method of claim 5 further comprising the steps of forming a second bore across the disc space partially overlapping said first bore, the combined width of said first and second bores being less than the sum of the individual diameters ofsaid first and second bores; and inserting said second implant.

7. The method of claim 1 in which the step of forming said bore includes the substep of removing a portion of bone parallel to the vertebral endplates of the adjacent vertebrae.

8. The method of claim 1, wherein the distracting step includes the step of inserting a spinal distractor into the disc space between the adjacent vertebrae to induce angulation to the adjacent vertebrae.

9. The method of claim 8, further comprising the step of positioning a sleeve over said spinal distractor and into contact with the adjacent vertebrae.

10. The method of claim 9, further comprising the step of removing said spinal distractor prior to the step of forming.

11. The method of claim 9, wherein the positioning step includes the step of positioning a sleeve having an extension for insertion into the disc space and for bearing against end plates of the adjacent vertebrae.

12. The method of claim 11, wherein the positioning step includes the sub-step of inducing angulation to the adjacent vertebrae.

13. The method of claim 12, wherein the inducing angulation step includes the step of restoring lordosis to the adjacent vertebrae.

14. The method of claim 12, wherein the inducing angulation step includes the step of restoring kyphosis to the asdjacent vertebrae.

15. The method of claim 9, wherein the forming step includes the sub-step of drilling the bore.

16. The method of claim 15, wherein the forming step further comprises the sub-step of placing a drill having a diameter greater than the disc space through said sleeve prior to the sub-step of drilling.

17. The method of claim 9, wherein the step of inserting includes the sub-step of inserting said implant through said sleeve and into the bore.

18. The method of claim 9, further comprising the step of placing an inner sleeve within said sleeve prior to the step of forming the bore.

19. The method of claim 18, further comprising the step of removing said inner sleeve prior to the step of inserting said implant.

20. The method of claim 1, wherein the forming step includes the sub-step of milling the bore.

21. The method of claim 1, further comprising the step of loading said implant with fusion promoting material prior to the step of inserting.

22. The method of claim 1, further comprising the step of loading said implant with osteogenic material prior to the step of inserting.

23. The method of claim 1, further comprising the step of coating said implant with bone morphogenic proteins prior to the step of inserting.

24. The method of claim 1, wherein the step of inserting includes inserting an implant containing a fusion promoting substance.

25. The method of claim 1, wherein the step of inserting includes inserting an implant comprising a fusion promoting substance.

26. The method of claim 1, wherein the step of inserting includes inserting an implant comprising a bone ingrowth surface.

27. A method for inserting at least one frusto-conical spinal fusion implant made of a material appropriate for human implantation, said implant having bone engaging means for engaging the adjacent vertebrae in a segment of the spinal column,comprising the steps of:

distracting the adjacent vertebrae;

forming a bore from the anterior or posterior aspect of the spinal column across the disc space and into the adjacent vertebrae, said bore being at least in part greater in diameter than the disc space between the distracted vertebrae such thatsome bone is removed from each of the adjacent vertebrae; and

inserting a frusto-conical spinal fusion implant into said bore.

28. The method of claim 27 in which said bore is generally cylindrical in shape.

29. The method of claim 22 in which said step of forming the step of includes using a drill having a substantially cylindrical shaped bone removing portion.

30. The method of claim 22 further comprising the step of inserting a second spinal fusion implant across the disc space so as to engage each of the adjacent vertebrae, said second implant being side by side and adjacent to said first implant.

31. The method of claim 30 further comprising the steps of forming a second bore across the disc space partially overlapping said first bore, the combined width of said first and second bores being less than the sum of the individual diametersof said first and second bores; and inserting said second spinal fusion implant into said second bore.

32. The method of claim 27 in which the step of forming said bore includes the substep of removing a portion of bone parallel to the endplates of the adjacent vertebrae.

33. The method of claim 27, wherein the distracting step includes the step of inserting a spinal distractor into the disc space between the adjacent vertebrae to induce angulation to the adjacent vertebrae.

34. The method of claim 33, further comprising the step of positioning a sleeve over said spinal distractor and into contact with the adjacent vertebrae.

35. The method of claim 34, further comprising the step of removing said spinal distractor prior to the step of forming.

36. The method of claim 41, wherein the positioning step includes the step of positioning a sleeve having an extension for insertion into the disc space and for bearing against end plates of the adjacent vertebrae.

37. The method of claim 34, wherein the positioning step includes the sub-step of inducing angulation to the adjacent vertebrae.

38. The method of claim 37, wherein the inducing angulation step includes the step of restoring lordosis to the adjacent vertebrae.

39. The method of claim 37, wherein the inducing angulation step includes the step of restoring kyphosis to the adjacent vertebrae.

40. The method of claim 34, wherein the forming step includes the sub-step of drilling the bore.

41. The method of claim 40, wherein the forming step further comprises the sub-step of placing a drill having a diameter greater than the disc space through said sleeve prior to the sub-step of drilling.

42. The method of claim 41, further comprising the step of placing an inner sleeve within said sleeve prior to the step of forming the bore.

43. The method of claim 42, further comprising the step of removing said inner sleeve prior to the step of inserting said implant.

44. The method of claim 34, wherein the step of inserting includes the sub-step of inserting said implant through said sleeve and into the bore.

45. The method of claim 27, wherein the forming step includes the sub-step of milling the bore.

46. The method of claim 22, further comprising the step of loading said implant with fusion promoting material prior to the step of inserting.

47. The method of claim 27, further comprising the step of loading said implant with osteogenic material prior to the step of inserting.

48. The method of claim 27, further comprising the step of coating said implant with bone morphogenic proteins prior to the step of inserting.

49. The method of claim 27, wherein the step of inserting includes inserting an implant containing a fusion promoting substance.

50. The method of claim 27, wherein the step of inserting includes inserting an implant comprising a fusion promoting substance.

51. The method of claim 27, wherein the step of inserting includes inserting an implant comprising a bone ingrowth surface.

52. A method for inserting a spinal implant across a disc space between adjacent vertebrae of a human spine, comprising the steps of:

distracting said adjacent vertebrae to induce angulation to the adjacent vertebrae;

forming a bore from the anterior or posterior aspect of the spinal column across the distracted disc space between said adjacent vertebrae and into the adjacent vertebrae, said bore having opposed arcuate portions in an angular relationship toone another along at least a portion of each of the adjacent vertebrae; and

inserting into said bore said spinal implant having opposed arcuate portions in an angular relationship to one another along the length of said implant and oriented toward the adjacent vertebrae.

53. The method of claim 52, wherein the distracting step includes the step of inserting a spinal distractor into the disc space between the adjacent vertebrae to induce angulation to the adjacent vertebrae.

54. The method of claim 53, further comprising the step of positioning a sleeve over said spinal distractor and into contact with the adjacent vertebrae.

55. The method of claim 52, further comprising the step of removing said spinal distractor prior to the step of forming.

56. The method of claim 54, wherein the positioning step includes the step of positioning a sleeve having an extension for insertion into the disc space and for bearing against end plates of the adjacent vertebrae.

57. The method of claim 56, wherein the positioning step includes the sub-step of inducing angulation to the adjacent vertebrae.

58. The method of claim 57, wherein the inducing angulation step includes the step of restoring lordosis to the adjacent vertebrae.

59. The method of claim 57, wherein the inducing angulation step includes the step of restoring kyphosis.

60. The method of claim 54, wherein the forming step includes the sub-step of drilling the bore.

61. The method of claim 60, wherein the forming step further comprises the sub-step of placing a drill having a diameter greater than the disc space through said sleeve prior to the sub-step of drilling.

62. The method of claim 54, wherein the step of inserting includes the sub-step of inserting said implant through said sleeve and into the bore.

63. The method of claim 54, further comprising the step of placing an inner sleeve within said sleeve prior to the step of forming the bore.

64. The method of claim 63, further comprising the step of removing said inner sleeve prior to the step of inserting said implant.

65. The method of claim 52, wherein the forming step includes the sub-step of milling the bore.

66. The method of claim 52, further comprising the step of loading said implant with fusion promoting material prior to the step of inserting.

67. The method of claim 54, further comprising the step of loading said implant with osteogenic material prior to the step of inserting.

68. The method of claim 52, further comprising the step of coating said implant with bone morphogenic proteins prior to the step of inserting.

69. The method of claim 52, wherein the step of inserting includes inserting an implant containing a fusion promoting substance.

70. The method of claim 52, wherein the step of inserting includes inserting an implant comprising a fusion promoting substance.

71. The method of claim 52, wherein the step of inserting includes inserting an implant comprising a bone ingrowth surface.

72. A method for inserting a spinal implant across a disc space between adjacent vertebrae of a human spine, comprising the steps of:

forming a bore from the anterior or posterior aspect of the spinal column across the disc space and into the adjacent vertebrae, said bore being at least in part greater in diameter than the distracted disc space such that some bone is removedfrom each of the adjacent vertebrae; and

inserting into said bore said spinal implant having opposed arcuate portions oriented toward the adjacent vertebrae, said arcuate portions being in a diverging relationship to one another along the length of said implant sufficient to induceangulation of the vertebrae.

73. The method of claim 72, further comprising the step of distracting the adjacent vertebrae prior to the forming step.

74. The method of claim 73, wherein the distracting step includes the step of inserting a spinal distractor into the disc space between the adjacent vertebrae to induce angulation to the adjacent vertebrae.

75. The method of claim 74, further comprising the step of positioning a sleeve over said spinal distractor and into contact with the adjacent vertebrae.

76. The method of claim 75, further comprising the step of removing said spinal distractor prior to the step of forming.

77. The method of claim 75, wherein the positioning step includes the step of positioning a sleeve having an extension for insertion into the disc space and for bearing against end plates of the adjacent vertebrae.

78. The method of claim 77, wherein the positioning step includes the sub-step of inducing angulation to the adjacent vertebrae.

79. The method of claim 78, wherein the inducing angulation step includes the step of restoring lordosis to the adjacent vertebrae.

80. The method of claim 78, wherein the inducing angulation step includes the step of restoring kyphosis.

81. The method of claim 75, wherein the forming step includes the sub-step of drilling the bore.

82. The method of claim 81, wherein the forming step further comprises the sub-step of placing a drill having a diameter greater than the disc space through said sleeve prior to the sub-step of drilling.

83. The method of claim 75, wherein the step of inserting includes the sub-step of inserting said implant through said sleeve and into the bore.

84. The method of claim 75, further comprising the step of placing an inner sleeve within said sleeve prior to the step of forming the bore.

85. The method of claim 84, further comprising the step of removing said inner sleeve prior to the step of inserting said implant.

86. The method of claim 72, wherein the forming step includes the sub-step of milling the bore.

87. The method of claim 72, further comprising the step of loading said implant with fusion promoting material prior to the step of inserting.

88. The method of claim 72, further comprising the step of loading said implant with osteogenic material prior to the step of inserting.

89. The method of claim 72, further comprising the step of coating said implant with bone morphogenic proteins prior to the step of inserting.

90. The method of claim 72, wherein the step of inserting includes inserting an implant containing a fusion promoting substance.

91. The method of claim 72, wherein the step of inserting includes inserting an implant comprising a fusion promoting substance.

92. The method of claim 72, wherein the step of inserting includes inserting an implant comprising a bone ingrowth surface.

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Description BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to a method for inserting interbody spinal fusion implants, and in particular to a method for inserting spinal fusion implants configured to restore and maintain two adjacent vertebrae of the spine inanatomical lordosis.

2. Description of the Related Art

Interbody spinal fusion refers to the method of achieving bony bridging between adjacent vertebrae through the disc space, the space between adjacent vertebrae normally occupied by a spinal disc. Numerous implants to facilitate such a fusionhave been described by Cloward, Brantigan, and others, and are known to those skilled in the art. Generally, cylindrical implants offer the advantage of conforming to an easily prepared recipient bore spanning the disc space and penetrating into each ofthe adjacent vertebrae. Such a bore may be created by use of a drill. It is an anatomical fact that both the cervical spine and the lumbar spine are normally lordotic, that is convex forward. Such alignment is important to the proper functioning ofthe spine. Commonly, those conditions which require treatment by spinal fusion are associated with a loss of lordosis.

Michelson, in U.S. patent application Ser. No. 08/396,414, entitled APPARATUS AND METHOD OF INSERTING SPINAL IMPLANTS, teaches a method for restoring the anatomical lordosis of the spine while performing the interbody fusion procedure. Whilethis has been a significant advance over prior methods, it has nevertheless been associated with a sometimes less than desirable consequence, that being the uneven removal of bone from each of the adjacent vertebrae relative to the vertebral endplatesadjacent the disc space.

Therefore, there exists a need for spinal fusion implants and instrumentation that permits for the uniform depth of bone removal from each of the adjacent vertebrae while restoring anatomical lordosis.

SUMMARY OF THE INVENTION

The present invention is directed to a method for inserting a variety of interbody spinal fusion implants having at least a partially frusto-conical configuration to achieve a desired anatomical lordosis of the spine. In the preferred embodimentof the method of the present invention, the spinal fusion implants being inserted have an outer locus in which at least some of the points of the implant comprise a partially or fully frusto-conical shape substantially along the portion of the implant incontact with the adjacent vertebrae of the spine and have an insertion end and a trailing end. The spinal fusion implants may be further modified so that while the upper and lower surfaces are portions of a frusto-cone, or a cylinder at least one sideportion may be truncated to form a planar surface that is parallel to the central longitudinal axis of the implant to form straight walls. These implants may have a more tapered aspect at the insertion end of the implant to facilitate insertion. Thespinal fusion implants of the present invention may be relatively solid and/or porous and/or hollow, and may have surface roughenings to promote bone ingrowth and stability.

In the preferred method of the present invention, the diseased disc between two vertebrae is at least partially removed. The two vertebrae adjacent the diseased disc are then optimally distracted and placed in the desired amount of lordosis byany of a number of well known means including, but not limited to, those means that distract the vertebral bodies by engaging screws placed into the anterior aspect of the vertebral bodies, and disc space distractors that are placed from the anterioraspect of the spine into the disc space and are then used to urge the vertebral endplates away from each other and into lordosis. When the correct amount of distraction and lordosis have been achieved at the affected disc level, then a frusto-conicalspace is created from anterior to posterior between the adjacent vertebrae. The frusto-conical space that is created is greater in diameter than the disc space height, such that some bone is removed from each of the adjacent vertebrae. The createdspace is generally frusto-conical in shape, being greatest in diameter anteriorly and tapering to a lesser diameter posteriorly.

In an alternative method of implant insertion, the use of at least partially frusto-conical interbody spinal fusion implants allows for the creation of lordosis by the implant itself where none is present to begin with. The disc space which inthe preferred circumstance would be fully distracted but need not be, but lacking lordosis, could have a bore drilled across that space such that equal arcs of bone are removed from each of the adjacent vertebrae using a drill or bone milling devicecapable of producing a cylindrical bore. The vertebrae, whether distracted from each other or not, are essentially lacking the full restoration of lordosis. The use of the substantially cylindrical bone drill provides for the removal of a generallyuniform thickness of bone from each of the adjacent vertebrae from anterior to posterior. The insertion of a frusto-conical implant, having a larger diameter at its trailing edge than at its leading edge, then forces the anterior aspects of the adjacentvertebrae apart more so than the posterior aspects where the diameter is lesser. This utilizes the implant to produce the desired lordosis.

To further assist incorporation into the spinal fusion bone mass, the spinal fusion implants of the present invention may have wells extending into the material of the implant from the surface for the purpose of holding fusion promoting materialsand to provide for areas of bone ingrowth fixation. These wells, or holes, may pass either into or through the implant and may or may not intersect. The spinal fusion implants of the present invention may have at least one chamber which may be incommunication through at least one opening to the surface of the implant. Said chamber may have at least one access opening for loading the chamber with fusion promoting substances. The access opening may be capable of being closed with a cap orsimilar means. Still further, a variety of surface irregularities may be employed to increase implant stability and implant surface area, and/or for the purpose of advancing the spinal fusion implant into the fusion site such as a thread. The exteriorof the spinal fusion implant of the present invention may have wholly or in part, a rough finish, knurling, forward facing ratchetings, threads or other surface irregularities sufficient to achieve the purpose described.

The spinal fusion implants of the present invention offer significant advantages over the prior art implants:

1. Because the spinal fusion implants of the present invention are at least partially frusto-conical in shape, those that taper from the leading edge to the trailing edge they are easy to introduce and easy to fully insert into the spinalsegment to be fused. In the preferred embodiment, where the leading edge of the implant is larger than the trailing edge, the implant utilizes a tapered forward portion and an increasing thread height relative to the body from the leading edge to thetrailing edge to facilitate insertion.

2. The shape of the implants of the present invention is consistent with the shape of the disc, which the implants at least in part replace, wherein the front of the disc is normally taller than the back of the disc, which allows for normallordosis. The implants of the present invention are similarly taller anteriorly than they are posteriorly.

3. The spinal fusion implants of the present invention allow for a minimal and uniform removal of bone from the vertebrae adjacent the disc space while still providing for an interbody fusion in lordosis when properly inserted.

4. The spinal fusion implants of the present invention conform to a geometric shape, which shape is readily producible at the site of fusion, to receive said spinal fusion implants.

The spinal fusion implants 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 metalssuch 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 spinal fusion implants of thepresent 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 or coatedwith 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 the present invention may be wholly or in partbioabsorbable.

OBJECTS OF THE PRESENT INVENTION

It is an object of the present invention to provide a method for inserting frusto-conical spinal fusion implants into the spine;

It is yet another object of the present invention to provide a method for inserting frusto-conical spinal fusion implants that are capable of maintaining anatomic alignment and lordosis of two adjacent vertebrae during the spinal fusion process;

It is yet another object of the present invention to provide a method for inserting frusto-conical spinal fusion implants that is capable of providing stability between adjacent vertebrae when inserted;

It is further another object of the present invention to provide a method of inserting frusto-conical spinal fusion implants that includes spacing apart and supporting adjacent vertebrae;

It is still further another object of the present invention to provide a method for inserting frusto-conical spinal fusion implants that is consistent in use with the preservation of a uniform thickness of the subchondral vertebral bone;

It is another object of the present invention to provide a method for inserting frusto-conical spinal fusion implants having a shape which conforms to an easily produced complementary bore at the fusion site; and

It is a further object of the present invention to provide a method for inserting a frusto-conical spinal fusion implant which may be placed side by side adjacent to a second identical implant across the same disc space, such that the combinedwidth of the two implants is less than sum of the individual heights of each implant.

These and other objects of the present invention will become apparent from a review of the accompanying drawings and the detailed description of the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevational view of a frusto-conical spinal fusion implant having a body that is frusto-conical with an external thread having a substantially uniform radius.

FIG. 1A is an enlarged fragmentary view along line 1A of FIG. 1 illustrating the surface configuration of the implant of FIG. 1.

FIG. 2 is a side elevational view of an alternative embodiment of the spinal fusion implant having a frusto-conical body with openings through the wall of the body.

FIG. 3A is an alternative embodiment of the spinal fusion implant having a frusto-conical body with an external thread radius and thread height that are not constant.

FIG. 3 is as cross sectional view along line 3–3 of the implant of FIG. 3A.

FIG. 4 is a side elevational view of an alternative embodiment of the spinal fusion implant having a frusto-conical body and a surface configuration comprising ratchetings for engaging bone, with wells and channels for bone ingrowth.

FIG. 5 is a cross sectional view along line 5–5 of the implant of FIG. 4 illustrating the channels and wells of the implant.

FIG. 6 is a cross sectional view along line 6–6 of the implant of FIG. 4 illustrating the channels and wells of the implant.

FIG. 6A is a side elevational view of an alternative embodiment of the spinal fusion implant having truncated sides forming a planar surface parallel to the longitudinal axis of the implant and ratchetings having a radius and height that are notconstant.

FIG. 6B is a top plan view of the spinal fusion implant shown in FIG. 6A.

FIG. 7 is a side elevational view in partial cut-away of an alternative embodiment of the spinal fusion implant having a body that is frusto-conical and a surface configuration comprising a plurality of spaced apart posts.

FIG. 8 is a side elevational view of an alternative embodiment of the spinal fusion implant of FIG. 1.

FIG. 9 is a side elevational view and partial cut-away of a segment of the spinal column in lordosis showing the spinal fusion implant of FIG. 8 being implanted with a driving instrument from the posterior approach to the spinal column.

FIG. 10 is a side elevational view of an alternative embodiment of the spinal fusion implant having a frusto-conical body and truncated sides.

FIG. 11 is an end view along line 11–11 of the spinal fusion implant of FIG. 14 shown placed beside a second identical implant shown in hidden line.

FIG. 12 is a side elevational view of an alternative embodiment of the spinal fusion implant having a body with an irregular configuration.

FIG. 13 is a side elevational view of a segment of the spinal column partially in lordosis showing a first drill and a second drill used in the method of the present invention.

FIG. 14 is a side elevational view of the spinal distractor instrument of the present invention.

FIG. 15 is a top plan view of the spinal distractor instrument of FIG. 14.

FIG. 16 is a side elevational view of a Posterior Long Lordotic Distractor inserted from the posterior aspect of the spine between adjacent vertebrae to restore and maintain lordosis of the spine.

FIG. 17 is a side elevational view of the Posterior Long Lordotic Distractor shown partially in hidden line with the Outer Sleeve and Cap, inserted between adjacent vertebrae to restore and maintain lordosis of the spine with the Outer Sleeveengaging the vertebrae and properly seated over the Posterior Long Lordotic Distractor.

FIG. 18 is a side elevational view partially in cross section of a spinal implant being inserted through an Outer Sleeve between two adjacent vertebrae of the spine in which lordosis has been restored and maintained and in which a portion of bonehas been removed from each vertebrae for receiving the spinal fusion implant.

FIG. 19 is a side elevational view of a spinal implant inserted between two adjacent vertebrae of the spine in which lordosis has been restored.

FIG. 20 is a side elevational view of a Posterior Short Lordotic Distractor of the present invention.

FIG. 21 is a top plan view along lines 21–21 of FIG. 20 of the Posterior Short Lordotic Distractor of the present invention.

FIG. 22 is a side elevational view of an Anterior Long Lordotic Distractor of the present invention shown inserted between two adjacent vertebrae from the anterior aspect of the spine to restore and maintain lordosis.

FIG. 23 is a perspective side view of the Extended Outer Sleeve of the present invention having extended members for insertion within the disc space and engaging means for engaging adjacent vertebrae of the spine.

FIG. 24 is a side elevational view of the Extended Outer Sleeve of FIG. 23 shown inserted between adjacent vertebrae of the spine.

FIG. 25 is an alternative embodiment of the Extended Outer Sleeve of FIG. 23 shown without an engaging means for engaging adjacent vertebrae.

FIG. 26 is a perspective side view of a Posterior Lordotic Extended Outer Sleeve of the present invention having uneven extended members for restoring and maintaining lordosis of the spine and engagement means for engaging the vertebrae.

FIG. 27 is a side elevational view of a portion of the Posterior Lordotic Extended Outer Sleeve of FIG. 26 inserted between adjacent vertebrae from the posterior aspect of the spine to restore and maintain lordosis.

FIG. 28 is a perspective side view of an Anterior Lordotic Extended Outer Sleeve of the present invention having extended members for restoring and maintaining lordosis of the spine from the anterior aspect of the spine.

FIG. 29 is a side elevational side view of an alternative embodiment of the Anterior Lordotic Extended Outer Sleeve of FIG. 28 absent the engagement means for engaging the vertebrae, inserted between adjacent vertebrae from the anterior aspect ofthe spine.

FIG. 30 is a perspective side view of a Dual Extended Outer Sleeve having an uneven extended portion which decreases in height in the direction of insertion.

FIG. 31 is bottom plan view of the foot plate of the Dual Extended Outer Sleeve of FIG. 30.

FIG. 32 is a perspective side view of a Dual Extended Outer Sleeve having uneven extended portions which decrease in height in the direction insertion.

FIG. 33 is an elevational front view of the apparatus of the present invention for use in installing interbody spinal implants having one or more flat sides, shown placed over two Long Distractors with the prongs inserted into the vertebrae.

FIG. 34 is a bottom plan view of the foot plate of the apparatus of the present invention for use in installing the interbody spinal implants having one or more flat sides.

FIG. 35 is a cross sectional view along line 35–35 of FIG. 33 illustrating the apparatus used for inserting interbody spinal implants having one or more flat sides.

FIG. 36 is a partial fragmentary view of the apparatus of the present invention for use in installing interbody spinal implants having one or more flat sides, shown with the prongs being partially inserted into the vertebrae.

FIG. 37 illustrates a step of the method of drilling a hole into a vertebrae with the apparatus of the present invention for use in installing interbody spinal implants having one or more flat sides, shown engaged to two adjacent vertebrae of aspinal column.

FIG. 38 illustrates a step of the method of the present invention for inserting a second interbody spinal implant having one or more flat sides into the interspace between two adjacent vertebrae with one implant shown already installed in place.

DETAILED DESCRIPTION OF THE DRAWINGS

The first part of the Detailed Description Of The Drawings is directed to the description of the structure of the frusto-conical implants inserted by the method of the present invention. The second part of the description of the drawings isdirected to the method of the present invention.

Frusto-Conical Implants

Referring to FIG. 1, a side elevational view of the spinal fusion implant for insertion with the method of the present invention generally referred to by numeral 20 is shown. The implant 20 has a body 22 that is frusto-conical in shape such thatthe body 22 has a diameter (root diameter) that is generally frusto-conical. The body 22 has an insertion end 24 and a trailing end 26. The insertion end 24 may include a tapered portion 25 to facilitate insertion of the spinal implant 20. In thepreferred embodiment, when the implant 20 is inserted from the anterior aspect of the spine, the body 22 of the implant 20 has a maximum diameter at a point nearest to the trailing end 26 and a minimum diameter at a point nearest to the insertion end 24.

The implant 20 has an external thread 28 having a substantially uniform radius R.sub.1 measured from the central longitudinal axis L.sub.1 of the implant 20. The outer locus of the external thread 28 (major diameter) has an overall configurationthat is substantially parallel to the longitudinal axis L.sub.1. While the major diameter of the implant 20 is substantially uniform, the external thread 28 may be modified at the leading edge by having initially a reduced thread radius to facilitateinsertion of the implant 20 and may also be modified to make the external thread 28 self-tapping. In the preferred embodiment, the external thread 28 has a first thread 30 of a lesser radius than the radius R.sub.1 of the remainder of the externalthread 28 to facilitate insertion of the implant 20. The second thread 32 has a greater radius than the first thread 30, but is still shorter than the radius R.sub.1 of the remainder of the external thread 28 which is thereafter of constant radius.

The body 22 is frusto-conical substantially along the portion of the body 22 in contact with the adjacent vertebrae of the spine which allows for the creating and maintaining of the adjacent vertebrae of the spine in the appropriate angularrelationship to each other in order to preserve and/or restore the normal anatomic lordosis of the spine. The substantially uniform radius R.sub.1 of the external thread 28 of the implant 20 allows for the engaging of the bone of the adjacent vertebraein a position that counters the forces which tend to urge the implant 20 from between the adjacent vertebrae in the direction opposite to which the implant 20 was implanted. The greater thread height measured from the body 22 near the leading end 24 ofthe implant 20 provides greater purchase into the vertebral bone and again enhances the stability of the implant 20. Further, the configuration of the external thread 28 increases the surface area of the implant 20 in contact with the vertebrae topromote bone ingrowth.

The implant 20 has a recessed slot 34 at its trailing end 26 for receiving and engaging insertion instrumentation for inserting the implant 20. The recessed slot 34 has a threaded opening 36 for threadably attaching the implant 20 toinstrumentation used for inserting the implant 20.

Referring to FIG. 1A, the implant 20 has an outer surface 38 that is porous to present an irregular surface to the bone to promote bone ingrowth. The outer surface 38 is also able to hold fusion promoting materials and provides for an increasedsurface area to engage the bone in the fusion process and to provide further stability. It is appreciated that the outer surface 38, and/or the entire implant 20, may comprise any other porous material or roughened surface sufficient to hold fusionpromoting substances and/or allow for bone ingrowth and/or engage the bone during the fusion process. The implant 20 may be further coated with bioactive fusion promoting substances including, but not limited to, hydroxyapatite compounds, osteogenicproteins and bone morphogenic proteins. The implant 20 is shown as being solid, however it is appreciated that it can be made to be substantially hollow or hollow in part.

In the preferred embodiment, for use in the lumbar spine, the implant 20 has an overall length in the range of approximately 24 mm to 32 mm with 26 mm being the preferred length. The body 22 of the implant 20 has a root diameter at the insertionend 24 in the range of 8-20 mm, with 14-16 mm being the preferred root diameter at the insertion end, and a root diameter at the trailing end 26 in the range of 10-24 mm, with 16-18 mm being the preferred diameter at the trailing end 26, when saidimplants are used in pairs. When used singly in the lumbar spine, the preferred diameters would be larger.

In the preferred embodiment, the implant 20 has a thread radius R.sub.1 in the range of 6 mm to 12 mm, with 9-10 mm being the preferred radius R.sub.1. For use in the cervical spine, the implant 20 has an overall length in the range ofapproximately 10-22 mm, with 12-14 mm being the preferred length. The body 22 of the implant 20 has a root diameter at the insertion end 24 in the range of 8-22 mm, with 16-18 mm being the preferred root diameter at the insertion end when used singly,and 8-10 mm when used in pairs. The body 22 of the implant 20 has a root diameter at the trailing end 26 in the range of 10-24 mm, with 18-20 mm being the preferred root diameter at the trailing end 26 when used singly, and 10-12 mm when used in pairs;a thread radius R.sub.1 in the range of approximately 4-12 mm, with 9-10 mm being the preferred radius R.sub.1 when inserted singularly and 5-7 mm when inserted side by side in pairs.

Referring to FIG. 3, a cross sectional view along line 3–3 of the implant 120 is shown. The implant 120 has an outer wall 144 surrounding an internal chamber 146. The large and small openings 140 and 142 may pass through the outer wall 144 tocommunicate with the internal chamber 146. The internal chamber 146 may be filled with bone material or any natural or artificial bone growth material or fusion promoting material such that bone growth occurs from the vertebrae through the openings 140and 142 to the material within internal chamber 146. While the openings 140 and 142 have been shown in the drawings as being circular, it is appreciated that the openings 140 and 142 may have any shape, size configuration or distribution, suitable foruse in a spinal fusion implant without departing from the scope of the present invention.

The implant 120 has a cap 148 with a thread 150 that threadably attaches to the insertion end 124 of the spinal fusion implant 120. The cap 148 is removable to provide access to the internal chamber 146, such that the internal chamber 146 can befilled and hold any natural or artificial osteoconductive, osteoinductive, osteogenic, or other fusion enhancing material. Some examples of such materials are bone harvested from the patient, or bone growth inducing material such as, but not limited to,hydroxyapatite, hydroxyapatite tricalcium phosphate; or bone morphogenic protein. The cap 148 and/or the spinal fusion implant 120 may be made of any material appropriate for human implantation including metals such as cobalt chrome, stainless steel,titanium, plastics, ceramics, composites and/or may be made of, and/or filled, and/or coated with a bone ingrowth inducing material such as, but not limited to, hydroxyapatite or hydroxyapatite tricalcium phosphate or any other osteoconductive,osteoinductive, osteogenic, or other fusion enhancing material. The cap 148 and the implant 120 may be partially or wholly bioabsorbable.

Referring to FIG. 3A, an alternative embodiment of implant 120 is shown and generally referred to by the numeral 120′. The implant 120′ has a body 122′ similar to body 122 of implant 120 and has an external thread 128′ having a radius R.sub.3measured from the central longitudinal axis L.sub.3 of the implant 120′. The thread radius R.sub.3 is not constant throughout the length of the implant 120′ and the external thread 128′ has a thread height that is also not constant with respect to thebody 122′ of the implant 120′. In the preferred embodiment, the implant 120′ has an external thread 128′ with a radius R.sub.3 that increases in size from the insertion end 124′ to the trailing end 126′ of the implant 120′.

Referring to FIG. 4, an alternative embodiment of the spinal fusion implant of the present invention is shown and generally referred to by the numeral 220. The implant 220 has a frusto-conical body 222 and an outer locus that is generallyfrusto-conical substantially along the portion of the implant 220 that is in contact with the adjacent vertebrae of the spine. The implant 220 has a surface configuration of forward facing ratchetings 240 suitable for engaging the bone of the adjacentvertebrae. Each of the plurality of ratchetings 240 has a bone engaging edge 242 and ramped portion 244. The ratchetings 240 have a radius R.sub.4 measured from the central longitudinal axis L.sub.4 of the implant 220 that increases from the insertionend 224 to the trailing end 226. The height of the ratchetings 240 measured from the body 222 is constant throughout the length of implant 220.

The orientation of the ratchetings 240 makes the insertion of the implant 220 easier than its removal, as the ramped portions 244 act as an inclined plane on the way in, while the bone engaging edges 242 resist motion in the opposite directions. These forward facing ratchetings 240 tend to urge the implant 220 forward until the unremoved bone of the vertebrae blocks further motion resulting in a very stable spine and implant construct.

In the preferred embodiment, the bone engaging edges 242 of the ratchetings 240 have a height at a highest point measured from the body 222 (root diameter) of the implant 220 in the range of 0.25-2.0 mm, with the preferred height being 0.4 mm foruse in the cervical spine and 1.25 mm for use in the lumbar spine.

Referring to FIGS. 5 and 6, cross sectional views of implant 220 are shown. The implant 220 has channels 250 passing through the implant 220 and wells 260 formed in the surface of the implant 220. The wells 260 may or may not communicate withthe channels 250. In the preferred embodiment of implant 220, the channels 250 have a diameter in the range of 0.1 mm to 6 mm, with 2-3 mm being the preferred diameter. The wells 260 have a diameter in the range of 0.1 mm to 6 mm, with 1-3 mm being thepreferred diameter range. It is appreciated that although the channels 250 and wells 260 are shown having a generally rounded configuration, it is within the scope of the present invention that the channels 250 and wells 260 may have any size, shape,configuration, and distribution suitable for the intended purpose.

Referring to FIGS. 6A and 6B, an alternative embodiment of the implant 220 is shown and generally referred to by the numeral 220′. The implant 220′ is similar in configuration to implant 220 and has ratchetings 240′ having a radius R.sub.5measured from the longitudinal central axis L.sub.5 that increases in size from the insertion end 224′ to the trailing end 226′. The ratchetings 240′ each have a height measured from the body 222′ that is not constant throughout the length of theimplant 220′. In the preferred embodiment, the ratchet radius R.sub.5 and the ratchet height increase in size from the insertion end 224′ to the trailing end 226′.

As shown in FIG. 6B, the implant 220′ has truncated sides 270 and 272 forming two planar surfaces which are diametrically opposite and are parallel to the longitudinal axis L.sub.4. In this manner, two implants 2201 may be placed side by sidewith one of the sides 270 or 272 of each implant touching, such that the area of contact with the bone of the adjacent vertebrae and the ratchetings 240′ is maximized. Alternatively, the implant 220′ may have one truncated side.

Referring to FIG. 7, a side elevational view in partial cut-away of an alternative embodiment of the implant of the present invention is shown and generally referred to by the numeral 420. The implant 420 has a body 422 that is frusto-conical inshape substantially along the portion of the implant 420 that is in contact with the adjacent vertebrae of the spine and has an insertion end 424 and a trailing end 426. The implant 420 has an outer surface 438 that is capable of receiving and holdingbone, or other materials capable of participating in the fusion process and/or capable of promoting bone ingrowth. In the preferred embodiment, the surface 438 comprises a plurality of posts 440 that are spaced apart to provide a plurality ofinterstices 442 which are partial wells with incomplete walls capable of holding and retaining milled bone material or any artificial bone ingrowth promoting material. The implant 420 may be prepared for implantation by grouting or otherwise coating thesurface 438 with the appropriate fusion promoting substances.

Referring to FIG. 8, a side elevational view of an alternative embodiment of the spinal fusion implant of the present invention generally referred to by numeral 520 is shown. The implant 520 has a body 522 having a root diameter that isfrusto-conical in the reverse direction as that of implant 20 shown in FIG. 1, in order to preserve and/or restore lordosis in a segment of spinal column when inserted from the posterior aspect of the spine. The body 522 has an insertion end 524 and atrailing end 526. In the preferred embodiment, the body 522 of the implant 520 has a minimum diameter at a point nearest to the trailing end 526 and a maximum diameter at a point nearest to the insertion end 524. The insertion end 524 may have ananterior nose cone portion 530 presenting a tapered end to facilitate insertion.

The implant 520 has an external thread 528 having a substantially uniform radius R.sub.6 measured from the central longitudinal axis L.sub.6 of the implant 520, such that the external diameter of the external thread 528 (major diameter) has anoverall configuration that is substantially parallel to the longitudinal axis L.sub.6. It is appreciated that the thread 528 can have a major diameter that varies with respect to the longitudinal axis L.sub.6, such that the major diameter may increasefrom the insertion end 524 to the trailing end 526 or the reverse. The external thread 528 has a thread height measured from the body 522 that increases from the insertion end 524 to the trailing end 526.

Referring to FIG. 9, a segment of the spinal column S is shown with the vertebrae V.sub.1 and V.sub.2 in lordosis and an implant 520 shown being inserted from the posterior aspect of the spinal column S with an instrument driver D. The implant520 is inserted with the larger diameter insertion end 524 first in order to in initially distract apart the vertebrae V.sub.1 and V.sub.2 which then angle toward each other posteriorly as the implant 520 is fully inserted. It is appreciated that theinsertion of implant 520 does not require the adjacent vertebrae V.sub.1 and V.sub.2 to be placed in lordosis prior to insertion, as the full insertion of the implant 520 itself is capable of creating the desired lordotic angular relationship of the twovertebrae V.sub.1 and V.sub.2.

In the preferred embodiment of implant 520, for use in said lumbar spine, the implant 520 has an overall length in the range of approximately 24 mm to 30 mm, with 26 mm being the preferred length. The body 522 of the implant 520 has a rootdiameter at the insertion end 524 in the range of 12-22 mm, with 16 mm being the preferred root diameter at the insertion end, and a root diameter at the trailing end 526 in the range of 10-20 mm, with 14 mm being the preferred diameter at the trailingend 526. In the preferred embodiment, the implant 520 has a thread radius R.sub.6 in the range of 6 mm to 12 mm, with 8 mm being the preferred radius R.sub.6.

Referring to FIG. 10, an alternative embodiment of the spinal fusion implant of the present invention generally referred to by the numeral 620 and a partial fragmentary view of a second identical implant, generally referred to by the numeral 621are shown. The implant 620 has a body 622 that is partially frusto-conical in shape similar to body 22 of implant 20 shown in FIG. 1, and has an insertion end 624 and a trailing end 626. The body 622 of the implant 620 has truncated sides 670 and 672forming planar surfaces that are parallel to the longitudinal axis L.sub.7. In this manner, two implants 620 and 621 may be placed side by side, with one of the sides 670 or 672 of each implant with little space between them, such that the area ofcontact with the bone of the adjacent vertebrae is maximized. It is appreciated that the body 622 may also be cylindrical in shape and have truncated sides 670 and 672.

The implant 620 has an external thread 628 having a radius R.sub.6 measured from the central longitudinal axis L.sub.7 that may be constant, such that the major diameter or outer locus of the external thread 628 has an overall configuration thatis substantially cylindrical. It is appreciated that the external thread 628 may have a thread radius R.sub.7 that is variable with respect to the longitudinal axis L.sub.7 such that the major diameter or outer locus of the external thread 628 has anoverall configuration that is substantially frusto-conical.

Referring to FIG. 11, an end view of the implant 620 placed beside implant 621 is shown. The implant 620 has a thread radius that is substantially constant and has a thread height measured from the body 622 that is greater at the sides 670 and672. In this manner, two implants 620 and 621 can be placed beside each other with the external thread 628 of each implant interdigitated allowing for closer adjacent placement of the two implants as a result of the substantial overlap of the externalthread 628 at the side 670 or 672 of the implants.

Referring to FIG. 12, an alternative embodiment of the implant of the present invention is shown and generally referred to by the numeral 700. The implant 700 is similar in configuration to implant 20 shown in FIG. 1, except that the body 722has an irregular configuration. The configuration of the body 722 has a root diameter D which is variable in size throughout the length of the implant 700 and, as shown in this embodiment, comprises larger diameter portions 750 and smaller diameterportions 752. It is appreciated that each of the large diameter portions 750 may be of the same or different diameter and each of the smaller diameter portions 752 may be of the same or different diameter.

The outer surface of the body 722 of implant 720 may be filled with fusion promoting substances such that the smaller diameter portions 752 may hold such fusion promoting substances. If so filled, the composite of the implant 700 and the fusionpromoting material could still produce an even external surface of the body 722 if so desired.

The Method Of The Present Invention

The embodiments of the frusto-conical implants of the present invention described above may be implanted with the method of the present invention described below.

In the preferred method of the present invention, the diseased disc between two vertebrae is at least partially removed from the anterior aspect of the spine. The two vertebrae adjacent the diseased disc are then optimally distracted and placedin the desired amount of lordosis by any of a number of well known means including, but not limited to, those means that distract the vertebral bodies by engaging screws placed into the anterior aspect of the vertebral bodies, and disc space distractorsthat are placed from the anterior aspect of the spine into the disc space and are then used to urge the vertebral endplates away from each other and into lordosis. When the correct amount of distraction and lordosis have been achieved at the affecteddisc level, then a frusto-conical space is created from anterior to posterior between the adjacent vertebrae. The frusto-conical space that is created is greater in diameter than the disc space height, such that some bone is removed from each of theadjacent vertebrae. The created space is generally frusto-conical in shape, being greatest in diameter anteriorly and tapering to a lesser diameter posteriorly.

It should be noted that where the spine is of sufficient width, it may be possible to prepare two such frusto-conical spaces side-by-side at the same disc level, allowing for the use of two implants instead of one. In either event, once thefrusto-conical space is prepared and all debris removed, the implant is then inserted into the prepared space across the disc space, penetrating into each of the adjacent vertebrae, from anterior to posterior.

In the preferred embodiment, the diseased disc is first removed by conventional discectomy. The depth of the disc space is then determined by direct measurement. An interspace distractor such as that described by Michelson in U.S. patentapplication Ser. No. 08/396,414 entitled Apparatus and Method of Inserting Spinal Implants, incorporated herein by reference, is then inserted into the disc space. A series of such distractors are available and are sequentially inserted until theoptimal amount of distraction across the disc space is achieved. The interspace distractors utilized for this purpose are wedged so as to induce physiological lordosis. An outer sleeve is then fitted over the barrel portion of the interspace distractorand firmly seated in engagement with the spine. As previously described in U.S. patent application Ser. No. 08/396,414, said outer sleeve may itself have extended portions capable of either maintaining or of obtaining and maintaining distraction. Said outer sleeve may also have vertebrae engaging prongs to further stabilize the outer sleeve to the spine and to more rigidly control motion at the adjacent vertebrae. As described in U.S. patent application Ser. No. 08/396,414, the use of theextended outer sleeve with distractor portions actually makes it possible to achieve the optimal distraction and lordosis without the use of the described interspace distractor. However, if the interspace distractor is used, then the outer sleeve isfully engaged to the spine, the distractor is removed, and in the preferred method by use of a slap-hammer, engaging the most proximal aspect of the distractor.

Referring to FIG. 13, a segment of the spinal column S is shown with vertebrae V.sub.1 and V.sub.2 shown in lordosis adjacent to disc space D.sub.1 and vertebrae V.sub.2 and V.sub.3 shown not in lordosis, but relatively parallel to each otheradjacent disc space D.sub.2. A first drill 810 making an opening 812 across the disc space D.sub.1, and into adjacent vertebrae V.sub.1 and V.sub.2, and a second drill 820 making an opening 822 across the disc space D.sub.2 and into adjacent vertebraeV.sub.2 and V.sub.3 are shown in FIG. 13. In the preferred embodiment, the interbody spinal fusion implant itself is threaded and frusto-conical in shape and therefore, the remaining portion of the procedure will be described in regard to thatparticular embodiment of the present invention, by way of example. With the disc space fully distracted and in anatomical lordosis and with the outer sleeve firmly engaged to the spine, it is then desirable to prepare the spine for receipt of theinterbody fusion implant. It is preferable to prepare a space across the disc space and penetrating into the adjacent vertebrae which space corresponds roughly to the root dimensions of the implant to be implanted. For this purpose, a stopped-out bonecutting instrument is inserted through the outer sleeve, the shape of the cutting portion of the first drill 510 generally corresponding to the frusto-conical shape of the root diameter of the implant being inserted. This instrument may take the form ofa frusto-conical drill or a mill and may be used to cut the bone by rotation, said rotation being achieved either through a manual handle or with power. Having prepared the space, the surgeon has two options. One is to remove the outer sleeve and then,because the implant is itself frusto-conical, screw the implant in using an implant driver capable of locking to the implant. The other is to leave the outer sleeve in place during the insertion of the implant.

If per the above, the surgeon wishes to remove the outer sleeve, the insertion of the implant itself causes a reproduction of the previous distraction which is easily achieved as the implant itself is frusto-conical in shape and the space createdby the removal of the bone to either side of the disc space essentially corresponds to the root diameter of the implant such that as the implant is inserted, the threads are embedded into the vertebrae adjacent the disc space. Once the implant is fullyinserted, the insertion apparatus is disconnected from the implant. If the cervical disc space is sufficiently wide from side-to-side, the procedure is performed in the same manner except that either a double-barrelled outer sleeve may be used or thepreviously described procedure essentially performed twice at the same disc level, such that a pair of implants may be inserted side-by-side.

In the alternative, if the surgeon wishes to leave the outer sleeve in place during the insertion of the implant and if the implant, as per this example has both a minor and a major diameter such as with a threaded implant, then the bone removingportion of the drilling means needs to generally correspond to the root diameter of the implant while the inside diameter of the outer sleeve needs to be great enough to allow the passage of the major diameter of the implant. It is desirable tostabilize the bone removal instrument and to assure that it removes equal portions of bone from each of the adjacent vertebrae. This may be achieved by a reduction sleeve which fits between the bone removal means and the inner wall of the outer sleeveand which essentially corresponds to the difference between the minor and major diameters of the implant, or some portion of the drill shaft proximal to the cutting end may have a diameter which corresponds to the major diameter of the implant even whilethe distal bone removing portion corresponds to the root diameter of the implant. In either way, the bone removal instrument is both stabilized and centered within the outer sleeve.

The approach to the lumbar spine may either be retroperitoneal, or transperitoneal. The procedure may be performed under direct vision, or laproscopically with the use of an endoscope. Generally it is preferable to utilize two implants whichare inserted in an anterior to posterior direction, one to either side of the midline. The implants may be inserted using either a single-barrelled or double-barrelled outer sleeve, and by the methods previously described in the pending U.S. patentapplication Ser. No. 08/396,414 from which the present methods differ only in the shape of the drill end or bone milling device which is essentially conical. As also previously described, in copending application Ser. No. 08/396,414, the methods canbe utilized for the insertion of non-threaded implants in which case said implants are linearly advanced rather than threaded in. And finally, as previously described in co-pending application Ser. No. 08/390,131, the implants themselves may havetruncations on the sides to form a planar surface parallel to the longitudinal axis of the implant, such that it is possible to fit two such implants more closely together by narrowing the width of each while preserving their height. As taught incopending application Ser. No. 08/396,414, a tap may be used after the drilling step and prior to the insertion of the implants.

Referring again to FIG. 13, in an alternative method of implant insertion, the use of at least partially frusto-conical interbody spinal fusion implants allows for the creation of lordosis by the implant itself where none is present to begin withas with the angular relationship of V.sub.2 and V.sub.3 shown in FIG. 13. As per this example, the disc space D.sub.2 which in the preferred circumstance would be fully distracted but need not be, but lacking lordosis, could have a bore drilled acrossthat space such that equal arcs of bone A.sub.1 and A.sub.2 are removed from each of the adjacent vertebrae V.sub.2 and V.sub.3 using a drill 820 or bone milling device capable of producing a cylindrical bore. Where one such boring is performed, itwould generally be in the center line and directed from anterior to posterior. This might be appropriate for use in the cervical spine. More commonly and as generally would be the rule in the lumbar spine, a pair of bores would be so created fromanterior to posterior, one to each side of the midline. The essential feature here is that the vertebrae V.sub.2 and V.sub.3, whether distracted from each other or not, are essentially lacking the full restoration of lordosis. The use of thesubstantially cylindrical bone drill 820 provides for the removal of a generally uniform thickness of bone from each of the adjacent vertebrae from anterior to posterior. The insertion of a frusto-conical implant, having a larger diameter at itstrailing edge than at its leading edge, then forces the anterior aspects of the adjacent vertebrae apart more so than the posterior aspects where the diameter is lesser. This utilizes the implant to produce the desired lordosis.

The method for the insertion of the spinal fusion implants of the present invention from the posterior aspect of the spine is described in detail in co-pending patent application Ser. No. 08/396,414 and is incorporated herein by reference. Further, in the method of inserting the implants of the present invention from the posterior aspect of the spine, it is possible to place the adjacent vertebrae in lordosis prior to the bone removal step.

Referring to FIGS. 14 and 15, spinal distractor 900 is shown which is used for distracting the adjacent vertebrae in lordosis prior to the bone removal step. The spinal distractor 900 has a tapered insertion end 902 to facilitate insertion, aninstrument engaging end 904, and top and bottom surfaces 906 and 908. The top and bottom surfaces 906 and 908 are in a angular relationship to each other and are furthest apart at a point near the insertion end 902 to produce the desired lordosis wheninserted in the disc space between two adjacent vertebrae. The top and bottom surfaces 906 and 908 have surface roughenings 910 for engaging the bone of the adjacent vertebrae and stabilizing the spinal distractor 900 when inserted.

When the human spine is viewed from the side, it consists of a balanced series of curves, as opposed to the vertebrae being stacked one upon another in a straight line when viewed from the side. In both the cervical and lumbar regions of thespine, the vertebrae relate to each other so as to form curves where the apex of said curves is displaced forward within the body, and those segments of the spine are said to be in lordosis. In contradistinction, in the thoracic portion of the spine,the vertebrae relate to each other so as to form a curve where the apex of said curve is displaced posteriorly and is said to be in kyphosis. The methods and instrumentation of the present invention have as one of its purposes to provide for thepermanent stabilization of contiguous vertebrae by fusion, there is then a need for a means to preserve said lordosis/kyphosis if present, or to restore said lordosis/kyphosis if already lost, prior to the completion of the fusion procedure.

The following embodiments of the present invention, either individually or in combination, provide for both the stabilization and fusion to be performed with the related vertebrae in the correct anatomic lordosis or kyphosis. Where it ispossible to approach the spine from various angles each of the devices, then has different forms appropriate to that specific approach.

Referring to FIG. 16, an alternative embodiment of the instrumentation of the present invention comprising a Posterior Long Lordotic Distractor 1400 capable of restoring and maintaining lordosis of adjacent vertebrae V from the posterior approachof the spine is shown. The Posterior Long Lordotic Distractor 1400 is inserted from the posterior aspect of the spine and comprises a barrel portion 1410 terminating at its distal end 1412 in a disc penetrating portion 1420 which is shown interposedwithin the disc space between two adjacent vertebrae V. The disc penetrating portion 1420 terminates distally into a leading bullet-shaped front end 1422 which facilitates the insertion of the disc penetrating portion 1420 between the adjacent vertebraeV. The disc penetrating portion 1420 is configured to have an uneven diameter such that it has a lesser diameter, and thus a lesser height within the disc space proximate the distal end 1412 of the barrel portion 1410 and has a greater diameter, and thusgreater height within the disc space, in the direction of the front end 1422. This configuration of the disc penetrating portion 1420 serves to not only restore the intervertebral disc space height upon insertion of the disc penetrating portion 1420 ofthe Posterior Long Lordotic Distractor 1400, but also serves to restore and maintain the normal lordosis between the adjacent vertebrae V. The leading bullet-shaped front end 1422 is of particular importance in regard to the Posterior Long LordoticDistractor 1400 where the largest diameter portion of the disc penetrating portion 1420 would otherwise be entering the disc space first.

The widest diameter of the disc penetrating portion 1420 is less than the diameter of the barrel portion 1410, such that a circumferential shoulder 1424 is formed at the distal end 1412 of the barrel portion 1410 which prevents over penetrationinto the disc space of the Posterior Long Lordotic Distractor 1400. It can readily be appreciated that such a configuration of the disc penetrating portion 1420 renders the Posterior Long Distractor 1400 quite stable within the disc space and resistantto backing out as the compressive forces of the spine upon the disc penetrating portion 1420 tend to urge it forward, while simultaneously the circumferential shoulder 1424 makes such further motion impossible, thus making the Posterior Long Distractor1400 exceedingly stable.

Referring to FIG. 17, in preparation for the bone removal step, the Posterior Long Lordotic Distractor 1400 is shown with the disc penetrating portion 1420 in place between the adjacent vertebrae V to restore and maintain lordosis of the spine. An Outer Sleeve 1140 described in reference to FIG. 5 of U.S. Pat. No. 5,484,437, is properly seated over the Posterior Long Lordotic Distractor 1400 using a mallet and the Driver Cap 160. While the bone removal step may be performed by either thedrilling method described in reference to FIGS. 11A and 11C or the “Trephine Method” described in reference to FIG. 11B of U.S. Pat. No. 5,848,437, the “Trephine Method” is preferred in this situation as it leaves the Posterior Long Lordotic Distractor1400 undisturbed until sufficient space has been created by the removal of bone at least as great as the thickness of the wall of the trephine 1270 itself to allow for the unobstructed removal of the Posterior Long Lordotic Distractor 1400.

If the “Trephine Method” described above in reference to FIG. 11B of U.S. Pat. No. 5,484,437 is used with the Posterior Long Lordotic Distractor 1400 the Outer Sleeve 1140 would first be fitted with an Inner Sleeve 1242 such as that shown inFIG. 11B, prior to both being placed simultaneously down over the barrel portion 1410 of the Posterior Long Lordotic Distractor 1400. Once the Outer Sleeve 1140 is concentrically seated relative to the barrel portion 1410, the Inner Sleeve 1242 alonewould be removed, and the trephine 1270 would then be placed over the Posterior Long Lordotic Distractor 1400 and within the confines of the Outer Sleeve 1140 and into the adjacent vertebrae V across the disc space to the appropriate depth. The use ofan Inner Sleeve is not required as the trephine 1270 is both centered and aligned by the Posterior Long Lordotic Distractor 1400.

In addition to cutting the two hemi-cylinders of bone, one for each vertebrae V, the saw-like sharp cutting teeth 1271 of the trephine 1270 shown in FIG. 11B removes a path of bone equal to the distance of the splaying out of each of the cuttingteeth 1271 relative to its neighbor and which distance cannot be less than the wall thickness of the trephine 1270 itself. Thus, once the trephine 1270 is removed, left behind is a semi-cylindrical space outlining each of the arcs of bone cut from theadjacent vertebrae V such that the two spaces combined provide for sufficient space such that it is then possible to extract the Posterior Long Lordotic Distractor 1400 without disturbing the vertebrae V themselves as the vertebrae V are held in positionby the Outer Sleeve 1140 which engages both of the vertebrae V.

Referring to FIGS. 18 and 19, since the vertebrae V are placed into lordosis prior to the bone removal step, the space S created by the bone removal is cut at an angle relative to the vertebrae V in the shape of a cylinder, and which correspondsto the shape of the cylindrical implant I. In this manner, the cylindrical implant I with parallel walls may be inserted between adjacent vertebrae V which have been stabilized for fusion in angular relationship to each other so as to preserve the normalcurvature of the spine.

Referring to FIGS. 20 and 21, an elevational side view and a top plan view, respectively, of a Posterior Short Lordotic Distractor 1500 for posterior use generally referred to by the numeral 1500 is shown. The Posterior Short Lordotic Distractor1500 is similar to the Short Distractor 1120 described in reference to the Convertible Distractor and comprises a disc penetrating portion 1520 identical to that of the Posterior Long Lordotic Distractor 1400 and an increased diameter head 128 asdescribed in reference to FIGS. 3-3F of U.S. Pat. No. 5,484,437. As discussed above for the Posterior Long Distractor 1400, the configuration of the disc penetrating portion 1520 renders the Posterior Short Lordotic Distractor 1500 quite stable. Thisis an especially important feature for the Posterior Short Lordotic Distractor 1500 because it is left under the delicate dural sac and nerves while work is being performed on the contralateral side of the spine. If the Posterior Short LordoticDistractor 1500 were other than stable, injury to these structures might result. To further prevent unwanted backing out of the Posterior Short Lordotic Distractor 1500, the bone engaging surface 1530 may be knurled or otherwise roughened, or haveforward facing ratchetings.

Referring to FIG. 22, an Anterior Long Lordotic Distractor 1600 for use anteriorly within the spine is shown. It can be seen that the configuration of the disc penetrating portion 620 is the reverse of the disc penetrating portion 1420 of thePosterior Long Lordotic Distractor 1400 in that the disc penetrating portion 1620 is of greatest diameter and height proximate the barrel portion 1610 and that the diameter and height are diminished more distally in the direction towards the front end1622 along the disc penetrating portion 1620. The Anterior Long Lordotic Distractor 1600 serves to restore and maintain lordosis of the spine by distraction of the adjacent vertebrae V. As described above for the Posterior Short Lordotic distractor1500, it is appreciated that an Anterior Short Lordotic Distractor (not shown) having a disc penetrating portion 1520 may be similarly devised.

It can be seen that all of the lordotic distractors, both the anterior and the posterior embodiments, have specialized leading bullet-shaped or nosecone-shaped portions so as to facilitate the insertion of the disc penetrating portions within thedisc space. This is of particular importance in regard to the Posterior Lordotic Distractors where the largest diameter portion of the disc penetrating portion 1420 would otherwise be entering the disc space first.

Referring to FIGS. 23 and 25, an alternative embodiment of the present invention for maintaining distraction during the surgical procedure involves a more specialized form of the previously described Outer Sleeve 1140 and is shown and identifiedas the Extended Outer Sleeve 1700. The Extended Outer Sleeve 1700 comprises a hollow tubular member 1702 having a distal end 1710 which has been extended such that a pair of extended portions 1720 and 1722, which are essentially a continuation of thehollow tubular member 1702 itself (with or without reinforcement), are opposed 180 degrees from each other, tapered at their leading edges 1724 and 1726 for ease of introduction, and of such height as to restore the height of the intervertebral discspace. Located at the distal end 1710 may be a plurality of teeth 1712, similar to those previously described above, or other engagement means for engaging the bone of the adjacent vertebrae V. It appreciated that the distal end 1710 may have no teeth1712.

The Extended Outer Sleeve 1700 is entirely a new invention such as has never existed in the art or science of surgery, the Extended Outer Sleeve 1700 offers numerous advantages over all previously described drilling sleeves and the Outer Sleeve1140 herein previously described. The Extended Outer Sleeve 1700 by dint of its extended portions 1720 and 1722 which are inserted between the adjacent vertebrae does itself act as an intervertebral distractor and is therefore essentially a combinationouter sleeve and distractor. The Extended Outer Sleeve 1700 is exceedingly stable as the extended portions 1720 and 1722 are trapped within the disc space and further held there by the considerable compressive loads within the spine.

Referring to FIG. 25, because of the stability thus provided, a further derivative advantage is that the teeth 1772 on the distal end 1710 of the Extended Outer Sleeve 1700′ may either be eliminated as shown in FIG. 26, or in the preferredembodiment be made of a lesser size. Further, it should be noted that teeth 1712 when present would be confined to the area directly in line with the vertebrae V and the extended portions 1720 and 1722 would ensure the proper rotatory alignment.

A further advantage, to be discussed in more detail subsequently, is that the extended portions 1720 and 1722 confine the surgery to the area within and between the extended portions 1720 and 1722 and protect all other tissues external to theextended portions 1720 and 1722.

Having now described the novel concept of the Extended Outer Sleeve 1700, attention may now be directed to further variations of the Extended Outer Sleeve 1700 capable of not only restoring and maintaining the appropriate intervertebral discspace height, but additionally being able to restore and maintain anatomic lordosis or kyphosis, as desired, throughout the surgical procedure.

Referring to FIG. 26, a Posterior Lordotic Extended Outer Sleeve 1800 for use from the posterior approach of the spine is shown. The Posterior Lordotic Extended Outer Sleeve 1800 comprises a hollow tubular member 1802 having a distal end 1810which has been extended such that a pair of extended portions 1820 and 1822, which are essentially a continuation of the tubular member 1802, are opposed 1180 degrees from each other. The extended portions 1820 and 1822 differ from the extended portions1720 and 1722 in that the extended portions 1820 and 1822 are configured to restore and maintain lordosis of the spine similar to the disc penetrating portion 1420 of the Posterior Long Lordotic Distractor 1400, the features of which are hereinincorporated by reference.

The extended portions 1820 and 1822 each have a height that is lesser at a point proximate the distal end 1810 of the tubular member 1802 that increases in the direction away from the tubular member 1802. The extended portions 1820 and 1822 aretapered at their leading edges 1824 and 1826, respectively to facilitate insertion into the disc space.

Between the extended portions 1820 and 1822, may be a plurality of teeth 1812 for engaging the bone of the vertebrae V when the Extended Outer Sleeve 1800 is inserted within the disc space between the adjacent vertebrae V.

Referring to FIG. 27, a Posterior Lordotic Extended Outer Sleeve 800′ in place within the intervertebral disc space is shown.

Referring to FIG. 28, an Anterior Extended Outer Sleeve 900 for use from the anterior approach of the spine is shown. The Anterior Lordotic Extended Outer Sleeve 1900 comprises a hollow tubular member 1902 having a distal end 1910 which has beenextended such that a pair of extended portions 1920 and 1922 which are essentially a continuation of the tubular member 1902 and are opposed 1180 degrees from each other. The extended portions 1920 and 1922 differ from the extended portions 1820 and1822 in that the extended portions 1920 and 1922 are configured to restore and maintain lordosis of the spine from the anterior approach similar to the disc penetrating portion 1620 of the Anterior Long Lordotic Distractor 1600, the features of which areherein incorporated by reference.

The extended portions 1920 and 1922 each have a height that is greater at a point proximate to the distal end 1910 of the tubular member 1902 that decreases in the direction away from the tubular member 1902. The extended portions 1920 and 1922are tapered at their leading edges 1924 and 1926, respectively to facilitate insertion into the disc space.

While the Lordotic Extended Outer Sleeve for use anteriorly is shown in the singular form and in use in the lumbar spine, it is understood that it may take a double barrelled form and in either form, be used throughout the spine.

Referring to FIGS. 29 and 30, a Lumbar Dual Extended Outer Sleeve is shown and generally referred to by the numeral 2100. The Dual Extended Outer Sleeve 2100 comprises two hollow tubular members 2101 and 2102. The two hollow tubular members2101 and 2102 have a distal end 2104 which has been extended to form an extended portion 2121 which is essentially a continuation of the hollow tubular members 2101 and 2102 joined together. The extended portion 2121 is similar in shape and function tothe extended portions 2920 and 2922 described above in reference to FIG. 31. The extended portion 2121 has a height that is greater at a point proximate the distal end 2104 and decreases in the direction away from the hollow tubular members 2101 and2102, in order to maintain the normal curvature of th e spine by correcting the angular relationships of the vertebrae V. The extended portion 2121, is tapered at its leading edge 2124 to facilitate insertion of the extended portion 2121 into the discspace between two adjacent vertebrae V. Located at the distal end of the tubular members 2101 and 2102 are sharpened teeth 2130 for engaging the vertebrae V.

Each of the hollow tubular members 2101 and 2102 are displaced from each other ideally the sum of the difference between the minor and major diameters of two threaded spinal implants I combined, but not less than that difference for one implantI, as it is possible to have the threads of one implant I nest interposed to the threads of the other implant I such that they both occupy a common area between them. Typically, the walls of each hollow tubular members 2101 and 2102 have a combinedthickness at the point which the walls of the hollow tubular members 2101 and 2102 are in contact with each other which is approximately 2.0 mm. This is achieved by machining away part of each hollow tubular member 2101 and 2102 to reduce the wallthickness of each hollow tubular member 1101 and 1102 prior to joining them together. In this manner, the two hollow tubular members 2101 and 2102 may be placed closer together so that two spinal implants I may be placed closer together when insertedwithin the disc space between adjacent vertebrae W. The hollow tubular member 2101 and 2102 can be overlapped or displaced from each other so as to control the distance between implants when the Dual Extended Outer Sleeve is utilized and two implantsimplanted.

The hollow tubular members 2101 and 2102 may be bridged in part or wholly throughout their length, but are typically fixed by a foot plate 2110, similar in function, but not in configuration, to Foot Plate 344 described above in reference toFIGS. 7C and 7D.

Referring specifically to FIG. 31, the foot plate 2110 has an oval configuration that contours and hugs the vertebrae and has a plurality of prongs 2112-2115 extending from the bottom of the foot plate 2110 is shown. The prongs 2112-2115 aresufficiently long to engage the bone of adjacent vertebrae V, but limited in length so as not to over penetrate beyond the vertebrae once inserted.

Referring to FIG. 32, a second Dual Extended Outer Sleeve 2200, is shown. The Dual Extended Outer Sleeve 1200 is similar to the Dual Extended Outer Sleeve 2100, except that it has additional extended portions 2220 and 2222 which have a heightthat is greater near the distal end 2204 of the hollow tubular members 2201 and 2202 and decreases in the direction away from the hollow tubular members 2201 and 2202. The extended portions 2220-2222 are similar in shape and function to the extendedportions 2920 and 2922 described above in reference to FIG. 31. Moreover, as the foot plate 2210 is rectangular and larger than foot plate 2110, additional prong 2216 and 2217 may be added.

Further, it should be appreciated that the lordotic distractor for use posteriorly when referring to their use in the lumbar spine, would be used anteriorly if applied to the thoracic spine, either in the single or double-barrel form. This isbecause the thoracic spine is normally curved into kyphosis which is the reverse of lordosis. That is, in approaching the thoracic spine anteriorly, it would be desirable to distract the back of the disc space more than the front, and that would requirean Extended Outer Sleeve which would resemble that seen in FIG. 28; though when used in this new context, it would more correctly be referred to as an Anterior Thoracic Kyphotic Extended Outer Sleeve. As with the Posterior Lordotic Outer Sleeve, thePosterior and Anterior Long Lordotic Posterior Short Lordotic Distractor and Anterior Short Lordotic Distractors, though referred to previously as lordotic when placed into the lumbar spine from the posterior approach, would now more correctly, whenplaced in the thoracic spine from the anterior approach be called Kyphotic Thoracic Distractors.

It can readily be appreciated that the described Extended Outer Sleeves may be used with the Short and Long Distractors having a disc penetrating portion of uniform diameter or in combination with the lordotic and kyphotic distractors ofcomplimentary configuration.

Referring to FIGS. 33-38, shown is the apparatus 2350 for use in installing an improved interbody spinal fusion implant 2300 having one or more flat sides as disclosed in co-pending application filed on Feb. 17, 1995, entitled IMPROVED INTERBODYSPINAL FUSION IMPLANTS which is incorporated herein by reference. The apparatus 2350 comprises a Dual Outer Sleeve 2310 having a pair of overlapping, hollow cylindrical tubes 2352 and 2354 identical in size and each having an internal diameter slightlylarger than the outer diameter of the spinal fusion implant. The cylindrical tubes 2352, 2354 are in communication with each other along their length and are displaced from each other ideally a distance that is slightly greater than the sum of thediameters of two spinal fusion implants 2300 placed side-by-side with the flat sides of each spinal fusion implant touching. The cylindrical tubes 2352 and 2354 are joined longitudinally such that they are partially overlapping. The hollow cylindricaltubes 2352 and 2354 are mounted on a foot plate 2362 similar to the foot plate described in FIG. 32. There are a series of prongs 2364a-2364f projecting from the bottom 2366 of the foot plate 2360 which are used to engage the Dual Outer Sleeve 2310 tothe base of the adjacent vertebrae V.

Referring specifically to FIG. 34, the apparatus 2350 is introduced over two Long Distractors 2320 and 2322 placed side-by-side and protruding anteriorly from the vertebrae V. The Long Distractors 2320 and 2322 are similar to the Long Distractor100 described in U.S. Pat. No. 5,484,437 except that they have a flat side 2324 and 2326, respectively.

Referring to FIGS. 34 and 35, in one embodiment, the foot plate 2360 is essentially rectangular, but without sharp corners. It is appreciated by those skilled in the art, that other shapes can be utilized.

As shown in FIGS. 33 and 36, the foot plate 1360 is contoured so as to approximate the external curvature of the vertebrae V anteriorly. Extending forward from foot plate 1360 are the multiple sharp prongs 2364a-2364f which are sufficiently longto permit fixation of the foot plate 2360 to the vertebrae V. The prongs 2364a-2364f are limited in length so as to not penetrate the vertebrae V too far posteriorly and number from 2 to 10, but preferably 6.

Referring to FIG. 36, as the Dual Outer Sleeve 2350 is driven forward, the prongs 2364a-2364f extending from foot plate 2360 are embedded into the opposed vertebrae V until their forward motion is inhibited by the foot plate 2360 becomingcongruent to and being stopped by, the anterior aspect of the vertebrae V.

As shown in FIG. 33, once the apparatus 2350 has been fully seated, the vertebrae V adjacent the interspace D to be fused are rigidly held via foot plate 2360 and the prongs 2364a-2364f. Thus, it is possible to remove either one, or if desired,both of the long distractors 2320 and 2322. The dual outer sleeve has been described above for inserting two implants each having at least one flat side, may have extended portions for intradiscal insertion which are capable of producing distraction aswell as kyphosis or lordosis as previously described with such extensions extending in line with the lateral walls of the cylindrical tubes.

Referring to FIG. 37, once the Dual Outer Sleeve 2350 has been fully seated, one of the Long Distractors 2320 and 2322 is removed and the surgeon may drill the interspace D utilizing drill 250 using each of the hollow cylinders 2352, 2354 toguide the drill 250 in order to create overlapping holes in which the spinal fusion implants 2300a and 2300b may be inserted. It is also appreciated by those skilled in the art, that a hollow inner sleeve (not shown) may be inserted into the hollowcylinders 2352, 2354 through which the drilling is performed or the Long Distractors may be left in place and a hollow trephine that fits over each of the Long Distractors 2320 and 2322 may be used to drill the interspace D. It is readily appreciatedthat the tubular members can be of a variety of shapes and sizes. Further, the removal of disc and bone may be accomplished by the use of a burr, or a chisel of appropriate shape for that purpose and with or without the use of a drill. The implantswould then have shapes appropriate for use in the spaces so formed.

Referring to FIG. 38, once the interspace D has been drilled, an implant Driver 350 described above is used to insert the spinal fusion implants 2300 and 2300b preferably by linear advancement. The implant driver instrument 350 may be used toeither insert or to remove the spinal fusion implants 2300a and 2300b.

Once affixed to the implant Driver 350, the spinal fusion implant 2300a is then introduced through one of the hollow cylindrical tubes 2352,2354 and driven into the interspace D by the application of an impaction force transmitted through theimplant driver instrument 350. Once the spinal fusion implant 2300a is inserted into the interspace D, the surface roughenings of the outer surface of the spinal fusion implant 2300a engage the bone of the vertebrae V and the implant Driver 350 isdetached from the spinal fusion implant 2300a. The implant driver instrument 350 is then withdrawn from the Dual Outer Sleeve 2350 and the spinal fusion implant 2300a is fully installed and inset in the interspace D as shown in FIG. 38.

Once a first spinal fusion implant 2300a is inserted into the interspace D, a second spinal fusion implant 2300b is driven into the interspace D so that the flat side 2302a or 2302b of each spinal fusion implant 2300a and 2300b are adjacent toeach other and are touching. In this manner, two spinal fusion implants 2300a and 2300b are implanted within the interspace D and engage the bone of the adjacent vertebrae V without exceeding the width of the spinal column. It is appreciated that thereare other ways that two spinal implants can have complimentary shapes and that they can be inserted by linear advancement through a single (both at once) or dual outer sleeve having intradiscal extended members for stabilization, distraction, and/or toeffect lordosis or kyphosis.

While the present invention has been described in detail with regards to the preferred embodiments, it is appreciated that other variations of the present invention may be devised which do not depart from the inventive concept of the presentinvention. In particular, it is appreciated that the various teachings described in regards to the specific embodiments herein may be combined in a variety of ways such that the features are not limited to the specific embodiments described above.

Each of the features disclosed in the various embodiments and their functional equivalents may be combined in any combination sufficient to achieve the purposes of the present invention as described herein.