Instrumentation and method for delivering an implant into a vertebral space

• US 7,081,120 B2
• Filed: 12/12/2002
• Issued: 07/25/2006
• Est. Priority Date: 04/26/1999
• Status: Expired due to Term

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Inventors: Li, Rhodemann, Li, Lehmann K.
• Primary Examiner(s): Pellegrino, Brian E.
• Application Number:
  US10/317,632
• Publication Number:
  US 20030125748A1
• Time in Patent Office: 1,321 Days
• Field of Search: 623/17.11, 623/17.12, 623/17.16, 623/908, 606/61, 606/99, 606/107
• US Class Current: 606/99
• 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 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4611 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 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30019 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2002/30075 swellable, e.g. when wetted
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30113 circular
• CPC Class Codes: A61F 2002/30125 elliptical or oval
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30136 undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
• CPC Class Codes: A61F 2002/30138 Convex polygonal shapes
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30293 Cylindrical body made by spirally rolling up a sheet or a strip around itself
• CPC Class Codes: A61F 2002/30324 differing in thickness
• CPC Class Codes: A61F 2002/30331 made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30494 Cooperating protrusions and recesses, e.g. radial serrations, located on abutting end surfaces of a longitudinal connection
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30588 : filled with solid particles
• CPC Class Codes: A61F 2002/30593 : hollow
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• 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 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• 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 2210/0061 : swellable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• 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 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts

Abstract

Instrumentation and method for delivering an implant into an intervertebral disc space, including a die member configured to transition the implant from an initial configuration to a deformed configuration having a reduced lateral profile suitable for insertion into the intervertebral disc space in a minimally invasive manner. In one embodiment, the die member includes an opening sized to receive the implant while in the initial configuration, and wherein relative displacement between the implant and the die member causes the implant to transition toward the reduced-profile deformed configuration. In a specific embodiment, the opening comprises an axial passage including a first portion having a rectangular cross-section corresponding to a substantially planar initial configuration of the implant, and a second portion having a circular cross-section corresponding to a substantially cylindrical deformed configuration of the implant.

Claims

1. Instrumentation for delivering an implant into a vertebral space, comprising:

a die member defining a passage extending along a longitudinal axis and sized to receive the implant while in an initial configuration, said passage bound by a first surface and an oppositely facing second surface; and

wherein said die member includes a number of projections extending transversely from at least one of said first and second surfaces and into said passage, said projections defining a tapered region extending along said axis and interacting with the implant such that relative displacement between the implant and said die member along said tapered region causes the implant to transition from the initial configuration to a deformed configuration having a reduced outer profile relative to the initial configuration.

2. The instrumentation of claim 1, wherein said number of projections comprise guides to facilitate transitioning of the implant from the initial configuration to a folded configuration.

3. The instrumentation of claim 1, wherein said passage extends along an axis, said passage including:

a first portion defining a first transverse dimension sized to receive the implant while in the initial configuration; and

a second portion defining a second transverse dimension less than said first transverse dimension; and

wherein axial displacement of the implant toward said second portion of said passage transitions the implant from the initial configuration toward the deformed configuration.

4. The instrumentation of claim 3, wherein said first portion of said passage has a substantially rectangular cross-section.

5. The instrumentation of claim 3, wherein said second portion of said passage has a substantially circular cross-section.

6. The instrumentation of claim 3, wherein said first portion of said passage has a substantially rectangular cross-section and wherein said second portion of said passage has a substantially circular cross-section.

7. The instrumentation of claim 3, wherein said passage is inwardly tapered in a transverse direction from said first portion toward said second portion to facilitate transitioning of the implant from the initial configuration toward the deformed configuration.

8. The instrumentation of claim 3, wherein said second transverse dimension is less than half of said first transverse dimension.

9. The instrumentation of claim 8, wherein said second transverse dimension is less than one-third of said first transverse dimension.

10. The instrumentation of claim 1, further comprising a delivery member adapted to engage and selectively retain the implant in the deformed configuration prior to insertion into the vertebral space.

11. The instrumentation of claim 10, wherein said delivery member is releasably coupled to said die member.

12. The instrumentation of claim 11, wherein said delivery member is releasably coupled to said die member by a frangible connection portion.

13. The instrumentation of claim 10, wherein said die member and said delivery member are unitarily formed as a single-piece structure.

14. The instrumentation of claim 10, wherein said delivery member defines a cavity extending at least partially therethrough, said cavity sized to receive the implant while in the deformed configuration.

15. The instrumentation of claim 14, wherein said delivery member comprises a cannula tube.

16. The instrumentation of claim 14, wherein said delivery member includes a discharge member at least partially disposed within said cavity and adapted to discharge the implant from said cavity and into the vertebral space.

17. The instrumentation of claim 16, wherein said discharge member comprises a rod axially displaceable along said cavity to engage the implant and to discharge the implant from said cavity and into the vertebral space.

18. The instrumentation of claim 17, wherein said at least one filament member comprises a suture.

19. The instrumentation of claim 18, wherein said suture comprises a suture loop extending through an aperture defined by the implant.

20. The instrumentation of claim 1, further comprising at least one force application member adapted to engage the implant and displace the implant relative to said die member to cause the implant to transition from the initial configuration toward the deformed configuration.

21. The instrumentation of claim 20, wherein said at least one force application member comprises at least one filament member engaged with the implant whereby axial tensioning of said at least one filament member results in axial displacement of the implant relative to said die member to cause the implant to transition from the initial configuration toward the deformed configuration.

22. The instrumentation of claim 1, wherein said die member is formed from a block of material.

23. The instrumentation of claim 1, further comprising deployment cannula having a proximal end and a distal end, said distal end configured to insert the implant into the vertebral space;

and

wherein said die member forms an inwardly decreasing taper in a direction from said passage to said deployment cannula so as to reconfigure the implant from a relatively flat configuration toward a substantially cylindrical configuration as the implant is displaced through said passage in said die member toward said deployment cannula.

24. The instrumentation of claim 23, further comprising means for applying a force onto the implant to displace the implant from said passage toward said deployment cannula.

25. The instrumentation of claim 23, further comprising means for discharging the implant from said deployment cannula and into the vertebral space.

26. The instrumentation of claim 23, further comprising means for releasably connecting said die member to said deployment cannula.

27. The instrumentation of claim 23, further comprising means for selectively retaining the implant in said substantially cylindrical configuration;

and means for inserting the implant into the vertebral space.

28. Instrumentation for delivering an implant into a vertebral space, comprising:

a die member defining a passage extending along a longitudinal axis and sized to receive the implant while in an initial configuration, said passage bound by a first surface and an oppositely facing second surface; and

wherein said die member includes a number of folding elements extending axially along at least a portion of said passage and extending transversely from at least one of said first and second surfaces and into said passage, said folding elements defining a tapered region extending along said axis and interacting with the implant such that relative displacement between the implant and said die member along said tapered region causes the implant to transition from the initial configuration to a deformed configuration having a reduced outer profile relative to the initial configuration.

29. The instrumentation of claim 28, wherein said folding elements have a triangular configuration.

30. The instrumentation of claim 28, wherein said folding elements are inwardly tapered toward one another relative to said longitudinal axis to facilitate transitioning of the implant from the initial configuration toward the deformed configuration.

31. Instrumentation for delivering an implant into a vertebral space, comprising:

a die member defining a passage extending along an axis and including a first portion defining a first transverse dimension sized to receive the implant while in the initial configuration and a second portion axially offset from said first portion and defining a second transverse dimension less than said first transverse dimension; and

wherein said die member is configured such that relative axial displacement of the implant toward said second portion of said passage transitions the implant from the initial configuration toward a deformed configuration having a reduced transverse profile relative to the initial configuration; and

wherein said die member includes a number of folding elements extending axially along at least a portion of said passage to facilitate transitioning of the implant from the initial configuration toward the deformed configuration, said passage bound by a first surface and an oppositely facing second surface, a first series of said folding elements extending from said first surface, a second series of said folding elements extending from said second surface.

32. The instrumentation of claim 31, wherein said first series of said folding elements are transversely offset relative to said second series of said folding elements.

33. The instrumentation of claim 32, wherein said first series of said folding elements are transversely disposed in an alternating manner relative to said second series of said folding elements.

34. Instrumentation for delivering an implant into a vertebral space, comprising:

a die member defining a passage extending along an axis and including a first portion defining a first transverse dimension sized to receive the implant while in the initial configuration and a second portion axially offset from said first portion and defining a second transverse dimension less than said first transverse dimension; and

wherein said die member is configured such that relative axial displacement of the implant toward said second portion of said passage transitions the implant from the initial configuration toward a deformed configuration having a reduced transverse profile relative to the initial configuration; and

wherein said die member defines a series of grooves extending axially along at least a portion of said passage to facilitate transitioning of the implant from the initial configuration toward the deformed configuration.

35. A method for delivering an implant into a vertebral space, comprising:

providing an implant and a delivery member;

providing a die member defining an opening sized to receive the implant while in an initial configuration, the delivery member releasably coupled to the die member;

displacing the implant relative to the die member;

transitioning the implant from the initial configuration to a deformed configuration having a reduced outer profile relative to the initial configuration;

selectively retaining the implant in the deformed configuration with the delivery member; and

discharging the implant from the delivery member and into the vertebral space while in the deformed configuration.

36. The method of claim 35, wherein the detaching comprises breaking.

37. A method for delivering an implant into a vertebral space, comprising:

providing a deformable spinal implant adapted for delivery into a vertebral space between adjacent vertebrae and configured to replace at least a portion of a natural intervertebral disc;

providing a die member defining an opening sized to receive the implant while in an initial configuration;

displacing the implant relative to the die member, the displacing causing the implant to transition from the initial configuration to a deformed configuration having a reduced outer profile relative to the initial configuration, the transitioning comprising drawing the implant across a number of guides defined by the die member; and

discharging the implant from the delivery member and into the vertebral space while in the deformed configuration.

38. The method of claim 37, further comprising temporarily retaining the implant in the deformed configuration.

39. The method of claim 37, further comprising:

providing a delivery member;

engaging the delivery member with the implant while in the deformed configuration; and

selectively retaining the implant in the deformed configuration prior to the inserting.

40. The method of claim 37, further comprising reforming the implant back toward the initial configuration.

41. The method of claim 37, wherein the opening in the die member comprises a passage extending along an axis, the passage including a first portion defining a first transverse dimension and a second portion defining a second transverse dimension less than the first transverse dimension, the first portion of the passage sized to receive the implant while in the initial configuration;

and wherein the method further comprises axial displacing the implant toward the second portion of the passage to transition the implant from the initial configuration toward the deformed configuration.

42. The method of claim 37, wherein the transitioning comprises folding.

43. The method of claim 37, wherein the displacing comprises applying a pulling force onto the implant.