Vertebral-column fusion devices and surgical methods

• US 6,656,178 B1
• Filed: 07/27/2000
• Issued: 12/02/2003
• Est. Priority Date: 07/28/1999
• Status: Expired due to Term

• Current Assignee: Baat B.V. Engineering, Depuy International Limited (Johnson & Johnson), Urquhart-Dykes & Lord LLP
• Original Assignee: Albert Gerrit Veldhuizen, Baat B.V. Engineering, Depuy International Limited (Johnson & Johnson)
• Inventors: Veldhuizen, Albert Gerrit, Sanders, Marc, Nijenbannin, Gert, Fenton, Gary Stuart, Pfleiderer, Martin, Birkbeck, Alec Paul
• Primary Examiner(s): Robert, Eduardo C.
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US09/626,817
• Time in Patent Office: 1,223 Days
• Field of Search: 606/61, 623/17.11, 623/17.13, 623/17.16
• US Class Current: 606/247
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30115 circular-O-shaped
• CPC Class Codes: A61F 2002/30126 oval-O-shaped
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30136 undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30143 hexagonal
• CPC Class Codes: A61F 2002/30148 lozenge- or diamond-shaped
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/3023 wedge-shaped cylinders
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30291 spirally-coiled, i.e. having a 2D spiral cross-section
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30326 differing in height or in length
• CPC Class Codes: A61F 2002/30329 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2002/30387 : Dovetail connection
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30823 : having the shape of a reverse dovetail
• CPC Class Codes: A61F 2002/30828 : parallel
• CPC Class Codes: A61F 2002/30904 : serrated profile, i.e. saw-toothed
• 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 2002/4619 : for extraction
• CPC Class Codes: A61F 2002/4622 : having the shape of a forceps or a clamp
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0019 : operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0023 : operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• 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 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0019 : rectangular
• 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 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0037 : differing in height or in length
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00077 : Copper or Cu-based alloys
• CPC Class Codes: Y10S 606/911 : Memory material

Abstract

A vertebral-column device that is suitable to be received in an intervertebral space between two dorsal vertebrae, the prosthesis comprising a curved strip of biocompatible material. The width of the strip being such that after placement, the strip makes contact with the vertebrae. The strip is manufactured from a material that can undergo great deformations before permanent deformation arises. The strip is curved in a shape in which the extremities are situated apart from one another and the radius of the curved parts and the thickness of the strip are chosen in such a way that when the strip is bent out into an approximately straight strip, scarcely any permanent deformation arises. Thus, the strip which has been bent out into an approximately straight strip is capable of being introduced into an intervertebral space where the strip assumes its original curved shape.

Claims

1. An intervertebral fusion device, the device having a single component comprising an elongate element, the elongate element providing one or more upper load bearing surfaces and one or more lower load bearing surfaces, to be engaged by respective vertebrae in use, the upper and lower load bearing surfaces being vertically spaced from one another by the elongate element, and the elongate element being rigid in a direction parallel to the vertical spacing of the upper and lower load bearing surfaces, the elongate element having a first state and a second state, the elongate element having a substantially linear configuration in the first state and a less linear configuration in the second state, the elongate element being capable of transition, at least once, from the second state to the first state and being capable of transition, at least once, from the first state to the second state, the elongate element being of shape memory alloy.

2. A fusion device according to claim 1, in which the first state provides a linear configuration for the elongate element.

3. A fusion device according to claim 1, in which the first state provides a configuration in which one end of the elongate element is further from the other end of the elongate element, measured along a straight line, than from any other part of the elongate element, the device having a waveform configuration.

4. A fusion device according to claim 1, in which the second state provides a configuration in which at least a part of the elongate element is curved.

5. A fusion device according to claim 1 in which the second state provides a configuration in which at least part of the elongate element is provided as a waveform and/or undulating strip.

6. A fusion device according to claim 1 in which in the second state the elongate element has a configuration which is a part circle and/or full circle and/or spiral and/or U-shape and/or a part oval and/or full oval.

7. A fusion device according to claim 1 in which the elongate element has a different thickness at one or more locations along its length than at other locations along its length, the reduced thickness locations extend across the full width of the elongate element.

8. A fusion device according to claim 7 in which the reduced thickness locations are provided by grooves in the elongate element.

9. A fusion device according to claim 7 in which the reduced thickness portions are preferentially provided in the portion or portions of the elongate element which undergo a change in profile during the transition from first to second state compared with the portion or portions of the elongate element which undergo no or a lesser change in profile during the transition from the first to second state.

10. A fusion device according to claim 1 in which the elongate element has a thickness of less than 3 mm.

11. A fusion device according to claim 1 in which the maximum extent of the elongate element, measured from any point to any other in a straight line, is less than 50 mm, when considered in the second state.

12. A fusion device according to claim 1 in which the elongate element has a non-rectilinear cross section at one or more locations along its length, a rectilinear cross section being provided at a location between those locations of non-rectilinear cross section.

13. A fusion device according to claim 12 in which the non-rectilinear cross section provides an increased thickness portion at the upper load bearing surface and at the lower load bearing surface of the elongate element.

14. A fusion device according to claim 1 in which the elongate element has an upper load bearing surface or surfaces and a lower load bearing surface or surfaces, the upper and lower load bearing surface and/or one or more of the upper and lower load bearing surfaces being parallel to one another.

15. A fusion device according to claim 14 in which the vertical spacing of the upper and lower load bearing surface or surfaces is between 7 mm and 20 mm.

16. A fusion device according to claim 14 in which the minimum vertical spacing is more than 4 mm.

17. A fusion device according to claim 1 in which the elongate element has an upper load bearing surface or surfaces and/or a lower load bearing surface or surfaces which are provided with serrations or spikes.

18. A fusion device according to claim 1 in which the upper and lower load bearing surface and/or one or more of the upper and lower load bearing surfaces are angled relative to one another, the angle between a projection of the upper load bearing surfaces and/or at least one of the upper load bearing surfaces and the lower load bearing surface and/or at least one of the lower load bearing surfaces, the angle being 5°

to 15°

.

19. A fusion device according to claim 1 in which the elongate element has one or more holes in it, the holes being round and/or oval and/or triangular and/or diamond shaped.

20. A fusion device according to claim 1 in which at least one end of the elongate element is provided with an engagement profile, the engagement profile defining a dovetail.

21. A method of surgery, the method including the acts of:

making an incision in the patient;

removing at least part of an intervertebral disc from the patient though the incision, thereby providing an intervertebral disc space; and

inserting a device into the intervertebral space;

the device having a single component comprising an elongate element, the elongate element providing one or more upper load bearing surfaces for a vertebrae and one or more lower load bearing surfaces for a vertebrae, the upper and lower load bearing surfaces being engaged by respective vertebrae in use, the upper and lower load bearing surfaces being vertically spaced from one another by the elongate element and the elongate element being rigid in a direction parallel to the vertical spacing of the upper and lower load bearing surfaces, the elongate element having a first state prior to insertion and a second state after insertion, the elongate element having a substantially linear configuration in the first state and a less linear configuration in the second state, the elongate element being capable of transition, at least once, from the second state to first state and being capable of transition, at least once, from the first state to the second state, the elongate element being of shape memory alloy.

22. A method according to claim 21 in which the shape memory alloy of the device is in a cold state in the first state and is in a warm state in the second state, the device being warmed, at least in part by the body heat of the patient, the warming causing the transition from cold to warm state for the memory metal of the device and hence from the first to the second state of the device.

23. A method according to claim 22 in which external heating of the device is applied, the temperature of the device in the patient being raised to at least 40 C.

24. An intervertebral fusion device, the device having a single component comprising an elongate element, the elongate element providing one or more upper load bearing surfaces and one or more lower load bearing surfaces to be engaged by respective vertebrae in use, the upper and lower load bearing surfaces being vertically spaced from one another by the elongate element and the elongate element being rigid in a direction parallel to the vertical spacing of the upper and lower load bearing surfaces, the elongate element having a first state and a second state, the elongate element having a substantially linear configuration in the first state and a less linear configuration in the second state, the elongate element being capable of transition, at least once, from the second state to first state and being capable of transition, at least once, from the first state to the second state, the elongate element being formed of a plurality of elongate components which at least in part extend alongside one another.

25. A fusion device according to claim 24 in which the elongate components (102) correspond to one another in form.

26. A fusion device according to claim 24 in which the elongate components are in the form of a plurality of equivalently configured strips, adjacent strips being in contact with one another.

27. A fusion device according to claim 24 in which the elongate components are connected together to form a single elongate element, the elongate components being connected together at one end.

28. An intervertebral fusion device, the device being a single component comprising a memory metal elongate element, the elongate element providing one or more upper load bearing surfaces and one or more lower load bearing surfaces for engaging respective vertebrae in use and being vertically spaced from one another by the elongate element, the elongate element being rigid in a directional parallel to the vertical spacing of the upper and lower load bearing surfaces having first and second ends and a substantially non-linear configuration between the two ends.

29. A fusion device according to claim 28 wherein the elongate element has a thickness and the substantially non-linear configuration defines a radius, and wherein the thickness and radius are predetermined so that, when the elongate element is straightened to form a substantially linear configuration, no deformations of more than 8% arise.

30. A fusion device according to claim 28 wherein the ratio of the radius to the thickness is at least 8:

1.

31. A method of using a prosthetic device, comprising the steps of:

a) providing an intervertebral fusion device, the device being a single component comprising a memory metal elongate element, the elongate element providing one or more upper load bearing surfaces and one or more lower load bearing surfaces for engaging respective vertebrae in use and being vertically spaced from one another by the elongate element, the elongate element being rigid in a directional parallel to the vertical spacing of the upper and lower load bearing surfaces having first and second ends and a substantially non-linear configuration between the two ends;

b) straightening the non-linear configuration of the elongate element to form a substantially linear configuration;

c) inserting the straightened device into the disc space, and

d) curving the substantially linear configuration of the elongate element to reform the non-linear configuration.