INTERVERTEBRAL IMPLANT AND INSTALLATION TOOL

• US 20110130838A1
• Filed: 05/21/2009
• Published: 06/02/2011
• Est. Priority Date: 05/26/2008
• Status: Abandoned Application

• Current Assignee: Interventional Spine, Inc (Johnson & Johnson)
• Original Assignee: Interventional Spine, Inc (Johnson & Johnson)
• Inventors: Morgenstern Lopez, Rudolf
• Application Number:
  US12/994,736
• Publication Number:
  US 20110130838A1
• Time in Patent Office: Days
• US Class Current: 623/17.16
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30242 spherical
• 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 2002/30383 made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30522 releasable, e.g. using a releasable ratchet
• CPC Class Codes: A61F 2002/3055 for adjusting length
• 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 2002/30571 Leaf springs
• CPC Class Codes: A61F 2002/30573 2-D spiral springs
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30594 slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30663 multiaxial, e.g. biaxial; multipolar, e.g. bipolar or having an intermediate shell articulating between the ball and the socket
• CPC Class Codes: A61F 2002/443 having two transversal endplates and at least one intermediate component
• 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 2002/4629 connected to the endoprosthesis or implant via a threaded connection
• 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 2230/0071 : spherical
• CPC Class Codes: A61F 2250/0007 : for adjusting length
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite

Abstract

An intervertebral implant (25), an installation tool (500), and related methods are provided for ensuring a minimum distance between two vertebrae. The implant (25) can comprise a pair of opposing body portions (1, 2) and an expansion component. The expansion component can rotate relative to the body portions (1, 2) in order to urge a head portion (4) thereof against one or more inclined contact surfaces of at least one of the body portions (1, 2). In this manner, the body portions (1, 2) can be separated, thereby increasing a height of the implant (25). The installation tool (500) can comprise a plurality of components that can be moved relative to each other to facilitate expansion or contraction of the implant (25).

Claims

1. An intervertebral implant for ensuring a minimum distance between two vertebrae, comprising:

a pair of opposing body portions each comprising an external surface and a contact surface that is oriented obliquely relative to the external surface, the body portions each comprising at least one raised structure and at least one gap positioned adjacent to the raised structure, the raised structure defining a top surface that forms at least a portion of the contact surface of the body portion, the raised structures of each body portion being insertable into the respective gaps of the other body portion such that the contact surfaces thereof define an internal wedge structure between the body portions; and

an expansion component comprising a head portion and a ram member, the expansion component being at least partially insertable between the body portions with the head portion positioned against the contact surfaces of the body portions, the ram member being operative to urge the head portion against the contact surfaces such that movement of the head portion against the internal wedge structure causes the body portions to separate thereby increasing a height of the implant.

2. The implant of claim 1, further comprising a confinement casing to prevent the movement of the head portion of the expansion component in a direction transverse to a longitudinal axis of the implant.

3. The implant of claim 2, wherein the confinement casing comprises a channel configured to receive at least a portion of the ram member therein.

4. The implant of claim 3, wherein the confinement casing comprises an elongate body having a lid at an end located distal to the channel and a compartment interposed between the lid and the channel, the compartment being at least partially defined by a pair of sidewalls extending intermediate the lid and an end of the channel, the compartment being configured to at least partially receive the body portions therein.

5. The implant of claim 3, wherein the channel is threaded and the ram member comprises at least one thread extending along an exterior surface thereof, the ram member being configured to threadingly engage the channel of the confinement casing.

6. The implant of claim 2, wherein the casing comprises one or more engagement surfaces disposed at a proximal end of the casing, the engagement surfaces being configured to engage with an expansion tool for maintaining a rotational orientation of the implant with respect to at least a portion of the expansion tool.

7. The implant of claim 1, wherein the ram member moves in a direction parallel to a longitudinal axis of the implant to urge the head portion against the contact surfaces of the body portions.

8. The implant of claim 1, further comprising a recovery element extending between the body portions.

9. The implant of claim 8, wherein the recovery element is a mesh with elastic properties, the recovery element at least partially surrounding the body portions.

10. The implant of claim 8, wherein the recovery element comprises an elastic rubber band.

11. The implant of claim 1, further comprising an expansion limiting system for limiting the expansion of the implant.

12. The implant of claim 11, wherein the expansion limiting system comprises a projection formed on one body portion that interferes with an end cap formed on the other body portion for limiting relative vertical motion between the body portions.

13. The implant of claim 1, wherein the external surfaces of the body portions comprise one or more projections for promoting osseointegration of the surfaces with adjacent vertebrae.

14. The implant of claim 1, wherein the expansion component comprises one or more engagement structures for engaging with an expansion tool for rotating the expansion component.

15. The implant of claim 14, wherein the expansion component comprises a threaded recess for engaging with an expansion tool for maintaining the expansion component in a given axial position relative to the tool during rotation of the expansion component.

16. An intervertebral implant for ensuring a minimum distance between two vertebrae, comprising:

a first body portion comprising a first external surface and a first contact surface, the first body portion comprising at least one raised structure and at least one gap positioned adjacent to the raised structure;

a second body portion comprising a second external surface and a second contact surface that is oriented obliquely relative to the first external surface, the second body portion comprising at least one raised structure and at least one gap positioned adjacent to the raised structure, the raised structure defining a top surface that forms at least a portion of the second contact surface of the body portion, each raised structure of the first body portion being insertable into the respective gap of the second body portion and each raised structure of the second body portion being insertable into the respective gap of the first body portion such that the contact surfaces thereof define an internal wedge structure between the first body portion and the second body portion;

an expansion component comprising a head portion and a ram member, the expansion component being at least partially insertable between the first body portion and the second body portion with the head portion positioned against the first and second contact surfaces, the ram member being operative to urge the head portion against the first and second contact surfaces such that movement of the head portion against the internal wedge structure causes the first body portion to separate from the second body portion thereby increasing a height of the implant.

17. The implant of claim 16, wherein the first contact surface of the first body portion is oriented obliquely relative to the first external surface.

18. The implant of claim 16, wherein the head portion of the expansion component is formed separately from the ram member.

19. The implant of claim 18, wherein the head portion of the expansion component comprises a generally spherical member.

20. The implant of claim 16, wherein the head portion of the expansion component is elastically deformable for providing a shock absorption capability to the implant.

21. The implant of claim 20, wherein the head portion is fabricated from one of nylon and Teflon.

22. The implant of claim 20, wherein the head portion comprises at least one cavity for enhancing the shock absorption capability of the implant.

23. The implant of claim 16, wherein the expansion component comprises one or more engagement structures for engaging with an expansion tool for rotating the expansion component.

24. The implant of claim 23, wherein the expansion component comprises a threaded recess for engaging with an expansion tool for maintaining the expansion component in a given axial position relative to the tool during rotation of the expansion component.

25. The implant of claim 16, further comprising a confinement casing having a channel and a compartment extending intermediate the channel and a distal end of the casing, the channel being configured to receive at least a portion of the ram member therein, the compartment being at least partially defined by a pair of sidewalls extending intermediate the distal end of the casing and the channel, the compartment being configured to at least partially receive the body portions therein, the confinement casing configured to align the body portions in a vertical direction and prevent movement of the expansion component in a direction transverse to a longitudinal axis of the implant.

26. The implant of claim 25, wherein the channel is threaded and the ram member comprises at least one thread extending along an exterior surface thereof, the ram member being configured to threadingly engage the channel of the confinement casing.

27. The implant of claim 25, wherein the casing comprises one or more engagement surfaces disposed at a proximal end of the casing, the engagement surfaces being configured to engage with an expansion tool for maintaining a rotational orientation of the implant with respect to at least a portion of the expansion tool.

28. An installation tool for an implant, the tool comprising:

a handle member having a gripping component and an elongate tubular component extending from the gripping component, the tubular component having a hollow bore and an engagement portion disposed at a distal end thereof, the engagement portion having one or more protrusions for engaging at least a portion of a proximal end of an intervertebral implant to maintain a rotational orientation of the implant relative to the tubular component;

a first rotating member having a first knob and an actuation component extending from the first knob, the actuation component having a hollow bore and a rotational connector disposed at a distal end thereof, the actuation component being configured to fit within the hollow bore of the tubular component of the handle member with the rotational connector being positioned adjacent to the engagement portion of the tubular component for engaging an expansion component of the implant for rotating the expansion component to expand or contract the implant; and

a second rotating member having a second knob and a retention component extending from the second knob, the retention component having a fastening portion disposed at a distal end thereof, the retention component being configured to fit within the hollow bore of the actuation component of the first rotating member with the retention component being positioned adjacent to the rotational connector of the actuation component of the first rotational member for engaging the expansion component of the implant for maintaining an axial position of the implant relative to the handle member during rotation of the expansion component.

29. The tool of claim 28, wherein the engagement portion of the tubular component of the handle member comprises a pair of protrusions.

30. The tool of claim 29, wherein the pair of protrusions are disposed on opposing sides of the tubular component with the implant being insertable therebetween.

31. The tool of claim 28, wherein the rotational connector of the actuation component of the first rotating member comprises a pair of linear protrusions configured to be received in a slot of the expansion component of the implant.

32. The tool of claim 28, wherein the tubular component of the actuation component and the retention component comprise generally cylindrical outer profiles.

33. The tool of claim 28, wherein the retention component of the second rotating member is configured to draw the expansion component of the implant toward the actuation component of the first rotational member as the retention component engages the ram member.

34. The tool of claim 33, wherein the fastening portion of the retention component is threaded for threadably engaging the ram member of the implant.

35. A method of implanting an expandable intervertebral implant, comprising:

dilating a pathway to an intervertebral disc;

removing the nucleus of an intervertebral disc to define a disc cavity;

scraping vertebral end plates from within the disc cavity; and

deploying an intervertebral implant in the disc cavity.

36. The method of claim 35, wherein the step of dilating comprises:

inserting a needle into the intervertebral disc;

inserting a first dilator over the needle into the intervertebral disc;

removing the needle.

inserting a second dilator over the first dilator into the intervertebral disc; and

removing the first dilator.

37. The method of claim 36, further comprising:

inserting a first working sleeve over the second dilator to adjacent the intervertebral space; and

removing the second dilator.

38. The method of claim 37, further comprising:

inserting a second working sleeve over the first working sleeve to adjacent the intervertebral space; and

removing the first working sleeve.

39. The method of claim 35, wherein the step of removing the nucleus comprises using a trephine tool.

40. The method of claim 39, wherein the step of removing the nucleus further comprises using a punch tool.

41. The method of claim 35, further comprising drilling a hole into the intervertebral disc after dilation.

42. The method of claim 41, wherein the step of drilling further comprises forming a hole in the vertebral end plates.

43. The method of claim 35, wherein the scraping step comprises inserting a rasp into the intervertebral disc to scrape the vertebral end plates from within the disc cavity.

44. The method of claim 35, wherein the step of deploying the implant comprises expanding the implant from approximately 9 mm to approximately 12.5 mm in height.