Osteogenic fusion device

• US 7,179,293 B2
• Filed: 08/05/2003
• Issued: 02/20/2007
• Est. Priority Date: 12/10/1997
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/634,711
• Publication Number:
  US 20040030393A1
• Time in Patent Office: 1,295 Days
• Field of Search: 623/17.11, 623/17.15, 623/17.16, 606/61
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/446 having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30116 partial circles, i.e. circular segments
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30166 H-shaped or I-shaped
• CPC Class Codes: A61F 2002/30169 Pi-shaped
• CPC Class Codes: A61F 2002/3021 frustoconical
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30293 : Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30383 : made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/304 : with additional means for limiting said sliding
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30777 : Oblong apertures
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3082 : Grooves
• CPC Class Codes: A61F 2002/3085 : with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
• CPC Class Codes: A61F 2002/30873 : Threadings machined on non-cylindrical external surfaces
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0023 : triangular
• CPC Class Codes: A61F 2230/0028 : Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2230/0047 : Pi-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00161 : Carbon; Graphite
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00359 : Bone or bony tissue
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs

Abstract

An interbody osteogenic fusion device is provided that includes opposite end pieces with an integral central element. The end pieces are sized to maintain the height of an intervertebral disc space. The central element has a much smaller diameter so that the osteogenic fusion device forms an annular pocke around the central element. An osteogenic material is disposed within the annular pocket between the opposite end pieces. In one embodiment,the osteogenic material constitutes a collagen sheet soaked in asolution containing a bone morphogenetic protein. The osteogenic fusion device is configured so that the osteogenic material is in direct contact with the adjacent vertebral bone. In addition to the enhanced area of contact between the vertebral bone and the fusion material, the inventive osteogenic fusion device reduces stress-shielding and minimizes the radiopacity of the implant so that growth of the fusion mass can be continuously assessed. In yet another embodiment, the osteogenic fusion device includes at least one end piece with a truncated surface. The osteogenic fusion devices of the present invention may be combined with other fusion devices to form an implant system. The implant system includes at least one load bearing member having a truncated surface configured to nest within another load bearing member, preferably the load bearing, osteogenic fusion device of the present invention. The invention also provides implant systems comprising adjacent load bearing members connected to one another to resist lateral separation. Methods of promoting fusion bone growth in the space between adjacent vertebrae utilizing devices and systems of the invention are also described.

Claims

1. An implant system for promoting fusion bone growth in the space between adjacent vertebrae, comprising:

at least first and second load bearing members adapted to be bilaterally placed between adjacent vertebrae, said load bearing members including

opposite end pieces and an elongated central element extending between said end pieces, said opposite end pieces having two opposite surfaces configured to contact and support the adjacent vertebrae,

said central element being sized smaller relative to said opposite end pieces to define a pocket between said central element and the adjacent vertebrae when the adjacent vertebrae are supported by said opposite end pieces, said pocket configured to contain an osteogenic material disposed about said central element and in intimate contact with the adjacent vertebrae when the vertebrae are supported by said opposite end pieces, and

at least said first load bearing member including at least one opposite end piece having a truncated surface that defines a cutout region; and

wherein at least one of said opposite end pieces of said second load bearing member is nested within said cutout region.

2. The implant system of claim 1, wherein said first load bearing member includes a first end piece and a second end piece, said first end piece including a truncated surface and having a first dimension between said two opposite surfaces and a second dimension transverse to said first dimension, said first dimension being greater than said second dimension, said first dimension being sized to maintain the space between adjacent vertebrae.

3. The implant system of claim 2, wherein said second end piece of said load bearing members includes truncated non-circular surfaces between said two opposite surfaces.

4. The implant system of claim 3, wherein said truncated non-circular surfaces are substantially flat.

5. The implant system of claim 4, wherein said first end piece of said load bearing members has an arcuate surface.

6. The implant system of claim 5, wherein each of said two opposing surfaces of said second end piece has an arcuate surface.

7. The implant system of claim 6, wherein said first end piece of said second load bearing member is substantially cylindrical and is nested within said first end piece of said first load bearing member.

8. The implant system of claim 7, wherein said first end piece of said second load bearing member includes a truncated surface.

9. The implant system of claim 1, wherein said truncated surface is concave.

10. The implant system of claim 1, further comprising an osteogenic material contained within each of said pocket of each of said load bearing members and arranged to contact the adjacent vertebrae when the vertebrae are supported by said opposite end pieces.

11. The implant system of claim 10, wherein said osteogenic material includes an osteogenic substance disposed within a carrier.

12. The implant system of claim 11, wherein said carrier is a collagen sheet wound around said central elements within each of said pocket of said load bearing members.

13. The implant system of claim 11, wherein said osteogenic substance is a bone morphogenetic protein.

14. The implant system of claim 11, wherein said two opposite surfaces of at least one of said end pieces includes threads.

15. A method of promoting fusion bone growth in the space between adjacent vertebrae, said method comprising:

(a) providing an implant system including first and second load bearing members adapted to be bilaterally placed between adjacent vertebrae, said load bearing members including;

opposite end pieces and an elongated central element extending between said end pieces, said opposite end pieces having two opposite surfaces configured to contact and support the adjacent vertebrae,

said central element being sized relative to said opposite end pieces to define a pocket between said central element and the adjacent vertebrae when the adjacent vertebrae are supported by said opposite end pieces, said pocket configured to contain an osteogenic material disposed about said central element and in intimate contact with the adjacent vertebrae when the vertebrae are supported by said opposite end pieces,

at least said first load bearing member including at least one opposite end piece having a truncated surface configured to nest within said second load bearing member;

a bone growth inductive material disposed around said central body and in intimate contact with the adjacent vertebrae when said central body is within the space between adjacent vertebrae;

(b) preparing said adjacent vertebrae to receive said implant in an intervertebral space between adjacent vertebrae; and

(c) placing said implant system into the intervertebral space after said preparing step, wherein said placing includes engaging one of the opposite end pieces of said second load bearing member with said truncated surface of said second load bearing member to nest said first load bearing member with said second load bearing member.

16. An implant system for promoting fusion bone growth in a space between adjacent vertebrae, comprising:

a first osteogenic fusion device including a first end piece, a second end piece, and a central element, said central element of said first fusion device extending between said first end piece of said first fusion device and said second end piece of said first fusion device, said central element of said first fusion device having an outer diameter;

wherein said first and second end piece of said first fusion device each have an outer diameter that is greater than said outer diameter of said central element of said first fusion device to minimize stress shielding along said central element of said first fusion device;

a second osteogenic fusion device including a first end piece, a second end piece, and a central element, said central element of said second fusion device extending between said first end piece of said second fusion device and said second end piece of said second fusion device; and

wherein said first end piece of said first fusion device has a cutout region defined by a truncated surface, said first end piece of said second fusion device being received in said cutout region of said first end piece of said first fusion device to nest said first fusion device with said second fusion device.

17. The system of claim 16, wherein said truncated surface has a concave shape.

18. The system of claim 17, wherein said first end piece of said second fusion device and said second end piece of said second fusion device each have a generally cylindrical shape.

19. The system of claim 16, wherein said second end piece of said first fusion device has a pair of opposite truncated surfaces disposed between a pair of bone contacting surfaces.

20. The system of claim 16, wherein said second end piece of said first fusion device has a cutout region defined by a truncated surface configured to nest with said second end piece of said second fusion device.

21. The system of claim 20, wherein:

said first end piece of said second fusion device has a cutout region defined by a truncated surface; and

said second end piece of said second fusion device has a cutout region defined by a truncated surface.

22. The system of claim 16, wherein:

said second end piece of said second fusion device has a cutout region defined by a truncated surface; and

said second end piece of said first fusion device is configured to nest within said cutout region in said second end piece of said second fusion device.

23. The system of claim 16, wherein:

said first fusion device and said second fusion device are configured to resist lateral expulsion;

said cutout region of said first end piece of said first fusion device defines an opening serving as a female member; and

said first end piece of said second fusion device having a mating member sized to fit within said opening of said first fusion device to serve as a male member.

24. The system of claim 23, wherein said first end piece of said first fusion device has a stop member positioned to be contacted with said mating member of said second fusion device.

25. The system of claim 23, further comprising a connecting plate spanning across said first end piece of said first fusion device and said first end piece of said second fusion device.

26. The system of claim 16, wherein when said first fusion device and said second fusion device are nested together a pocket is created to contain osteogenic material for promoting unshielded bone growth between the adjacent vertebrae.

27. An implant system for promoting fusion bone growth in the space between adjacent vertebrae including at least first and second load bearing members adapted to be bilaterally placed between adjacent vertebrae, said load bearing members comprising:

opposite end pieces and an elongated central element extending between said end pieces, said opposite end pieces having two opposite surfaces configured to contact and support the adjacent vertebrae;

said central element being sized smaller relative to said opposite end pieces to define a pocket between said central element and the adjacent vertebrae when the adjacent vertebrae are supported by said opposite end pieces, said pocket configured to contain an osteogenic material disposed about said central element and in intimate contact with the adjacent vertebrae when the vertebrae are supported by said opposite end pieces;

at least said first load bearing member including at least one opposite end piece having a truncated surface configured to nest within said second load bearing member;

an osteogenic material contained within each of said pocket of each of said load bearing members and arranged to contact the adjacent vertebrae when the vertebrae are supported by said opposite end pieces;

wherein said osteogenic material includes an osteogenic substance disposed within a carrier; and

wherein said carrier is a collagen sheet wound around said central elements within each of said pocket of said load bearing members.

28. An implant system for promoting fusion bone growth in a space between adjacent vertebrae, comprising:

first and second fusion devices, each of said devices including opposite end pieces and an elongated central element extending between said end pieces, said opposite end pieces having two opposite surfaces configured to contact and support the adjacent vertebrae, said central element being sized smaller relative to said opposite end pieces to define a pocket between said central element and the adjacent vertebrae when the adjacent vertebrae are supported by said opposite end pieces, said pocket configured to contain an osteogenic material disposed about said central element and in intimate contact with the adjacent vertebrae when the vertebrae are supported by said opposite end pieces;

wherein at least one of the opposing end pieces of the first fusion device defines a cutout region that is concave in shape and at least one of the opposing end pieces of the second fusion device is received in the cutout region to nest the second fusion device with the first fusion device.

29. The implant system of claim 28, wherein:

both the opposing end pieces of the first fusion device each have the cutout region that is concave in shape; and

both the opposing end pieces of the second fusion device are nested within respective ones of the opposing end pieces of the first fusion device.

30. The implant system of claim 29, wherein at least one of the opposing end pieces of the second fusion device defines a cutout region that is concave in shape.

31. The implant system of claim 30, wherein both the opposing end pieces of the second fusion device have the cutout region that is concave in shape.

32. The implant system of claim 28, wherein both the opposing end pieces of the second fusion device are generally cylindrical in shape.

33. The implant system of claim 28, wherein the end piece opposite the end piece with the cutout region in the first fusion device is generally cylindrical in shape.

34. The implant system of claim 28, wherein:

at least one of the opposite end pieces of the second fusion device has a male member;

the cutout region in at least one of the opposite end pieces of the first fusion device forms a female member; and

the male and female members interlock with one another to resist lateral separation of the first and second fusion devices.

35. The system of claim 34, wherein the first fusion device has a stop member positioned to be contacted with the male member of the second fusion device.

36. The system of claim 34, further comprising a connecting plate spanning across the first fusion device and the second fusion device.

37. The implant system of claim 28, wherein:

the end piece opposite the end piece with the cutout region in the first fusion device has non-circular surfaces that are substantially flat;

at least one end piece of the second fusion device has non-circular surfaces that are substantially flat; and

the first fusion device and the second fusion device contact one another at their respective non-circular surfaces.

38. The implant system of claim 28, wherein the opposite end pieces of the first fusion device are threaded.

39. The implant system of claim 28, further comprising osteogenic material packed in a pocket defined between the first fusion device and the second fusion device.

40. The implant system of claim 28, further comprising an insertion tool attached to the first fusion device.

41. An implant system for promoting fusion bone growth between vertebrae, comprising:

a first load bearing member including a first end piece, a second end piece and a central element that connects the first end piece of the first load bearing member to the second end piece of the first load bearing member, the central element being sized smaller relative to said opposite end pieces to define a pocket between said central element and the adjacent vertebrae when the adjacent vertebrae are supported by said opposite end pieces, said pocket configured to contain an osteogenic material disposed about said central element and in intimate contact with the adjacent vertebrae when the vertebrae are supported by said opposite end pieces;

a second load bearing member including a first end piece, a second end piece and a central element that connects the first end piece of the second load bearing member to the second end piece of the second load bearing member; and

wherein the first end piece of the first load bearing member has a truncated surface that defines a cutout region, and the first end piece of the second load bearing member is nested within said cutout region.

42. The implant system of claim 41, wherein the first and second end pieces of both the first and second load bearing members have an overall cylindrical shape to promote implantation.

43. The implant system of claim 42, wherein the truncated surface of the first load bearing member has a concave shape to receive the first end piece of the second load bearing member.

44. The implant system of claim 41, wherein the truncated surface of the first load bearing member has a concave shape to receive the first end piece of the second load bearing member.

45. A method, comprising:

providing first and second fusion devices, each of said devices including opposite end pieces and an elongated central element extending between said end pieces, said opposite end pieces having two opposite surfaces configured to contact and support the adjacent vertebrae, said central element being sized smaller relative to said opposite end pieces to define a pocket between said central element and the adjacent vertebrae when the adjacent vertebrae are supported by said opposite end pieces, said pocket configured to contain an osteogenic material disposed about said central element and in intimate contact with the adjacent vertebrae when the vertebrae are supported by said opposite end pieces;

forming a surgical window into a disc space between adjacent vertebrae;

implanting the first fusion device between the vertebrae by inserting the first fusion device through the surgical window, wherein at least one of the opposing end pieces of the first fusion device has a cutout region;

implanting the second fusion device between the vertebrae by inserting the second fusion device through the surgical window; and

nesting the second fusion device with the first fusion device within the surgical window by positioning at least a portion of one the end pieces of the second fusion device in the cutout region of the first fusion device.

46. The method of claim 45, further comprising:

wherein both the opposing end pieces of the first fusion device have the cutout region; and

wherein said nesting includes engaging the opposing end pieces of the second fusion device with the cutout regions of the first fusion device.

47. The method of claim 45, further comprising:

packing osteogenic material in a pocket formed between the first and second fusion devices.

48. The method of claim 45, further comprising:

wherein at least one of the opposing end pieces of the second fusion device has a cutout region; and

wherein said nesting includes positioning at least a portion of one the end pieces of the first fusion device in the cutout region of the second fusion device.

49. The method of claim 45, further comprising:

wherein at least one of the opposite end pieces of the second fusion device has a male member;

wherein the cutout region in at least one of the opposite end pieces of the first fusion device forms a female member; and

wherein said nesting includes interlocking the male member with the female member to resist lateral separation of the first and second fusion devices.

50. An implant system for promoting fusion bone growth in the space between adjacent vertebrae, comprising:

at least first and second load bearing members adapted to be bilaterally placed between adjacent vertebrae, said load bearing members including

opposite end pieces and an elongated central element extending between said end pieces, said opposite end pieces having two opposite surfaces configured to contact and support the adjacent vertebrae,

said central element being sized smaller relative to said opposite end pieces to define a pocket between said central element and the adjacent vertebrae when the adjacent vertebrae are supported by said opposite end pieces, said pocket configured to contain an osteogenic material disposed about said central element and in intimate contact with the adjacent vertebrae when the vertebrae are supported by said opposite end pieces,

at least said first load bearing member including at least one opposite end piece having a truncated surface; and

an osteogenic material contained within each of said pocket of each of said load bearing members and arranged to contact the adjacent vertebrae when the vertebrae are supported by said opposite end pieces;

wherein said osteogenic material includes an osteogenic substance disposed within a carrier;

wherein said carrier is a collagen sheet wound around said central elements within each of said pocket of said load bearing members; and

wherein at least one of said opposite end pieces of said second load bearing member contacts said truncated surface of said first load bearing member to nest the first and second load bearing members together.

51. An implant system for promoting fusion bone growth in a space between adjacent vertebrae, comprising:

a first fusion device being dumbbell shaped, the first fusion device including a central element that connects opposing end pieces;

a second fusion device being a dumbbell shaped, the second fusion device including a central element that connects opposing end pieces; and

wherein at least one of the opposing end pieces of the first fusion device defines a cutout region that is concave in shape and at least one of the opposing end pieces of the second fusion device is received in the cutout region to nest the second fusion device with the first fusion device;

wherein both the opposing end pieces of the first fusion device each have the cutout region that is concave in shape;

wherein both the opposing end pieces of the second fusion device are nested within respective ones of the opposing end pieces of the first fusion device; and

wherein at least one of the opposing end pieces of the second fusion device defines a cutout region that is concave in shape.