Trial implant and trial implant kit for evaluating an intradiscal space

• US 6,113,639 A
• Filed: 03/23/1999
• Issued: 09/05/2000
• Est. Priority Date: 03/23/1999
• Status: Expired due to Fees

• Current Assignee: Raymedica, Inc.
• Original Assignee: Raymedica, Inc.
• Inventors: Assell, Robert L., Ray, Charles D.
• Primary Examiner(s): Wilson, John J.
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/274,535
• Time in Patent Office: 532 Days
• Field of Search: 623/11, 623/17, 623/17.11, 623/17.16, 606/53, 606/60, 606/61, 33/511, 33/512
• US Class Current: 623/17.16
• CPC Class Codes: A61B 2050/0056 about a lateral axis in the lid plane
• CPC Class Codes: A61B 50/33 Trays
• 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 2/441 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 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30263 cubical
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• 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 2002/4622 having the shape of a forceps or a clamp
• CPC Class Codes: A61F 2230/0082 parallelepipedal
• CPC Class Codes: A61F 2230/0084 cubical

Abstract

A trial implant for evaluating a size of an intradiscal space for subsequent implantation of a prosthetic spinal disc nucleus. The trial implant is comprised of an elongated central body and a retrieving body. The elongated body is formed from a rigid, surgically safe material and preferably has a volume less than a volume of a nucleus cavity portion of the intradiscal space. The retrieving body is associated with the central body and is configured to facilitate retrieval of the trial implant from an enclosed area, such as the nucleus cavity. A plurality of trial implants are included with a trial implant kit, with each of the plurality of trial implants housing a different size and/or shape. During use, the trial implant provides an indication as to whether a similarly sized prosthetic spinal disc nucleus will fit within a particular intradiscal space.

Claims

1. A trial implant for evaluating a size of a nucleus cavity portion of an intradiscal space, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the trial implant comprising:

an elongated central body defining a superior face, an inferior face, opposing side faces and opposing end faces, the central body being formed of a rigid, surgically safe material and having a volume less than a volume of a nucleus cavity; and

a tab associated with the elongated central body for facilitating retrieval of the elongated central body from a nucleus cavity;

wherein a combination of the central body and the tab is sized to be encompassed by the anulus.

2. The trial implant of claim 1, wherein the superior face and the inferior face are relatively smooth.

3. The trial implant of claim 2, wherein the opposing side faces and the opposing end faces are relatively smooth.

4. The trial implant of claim 1, wherein the elongated central body is substantially rectangular.

5. The trial implant of claim 1, wherein the elongated central body is substantially wedge-shaped.

6. The trial implant of claim 5, wherein the superior face and the inferior face extend in an angular fashion from a first one of the opposing side faces to a second one of the opposing side faces such that the first opposing side face has a height less than a height of the second opposing side face.

7. The trial implant of claim 6, wherein each of the opposing end faces is approximately trapezoidal.

8. The trial implant of claim 5, wherein the opposing end faces extend in an angular fashion from a first one of the opposing side faces to a second one of the opposing side faces such that the first opposing side face has a length less than a length of the second opposing side face.

9. The trial implant of claim 8, wherein the top face and the bottom face are approximately trapezoidal.

10. The trial implant of claim 1, where the elongated central body is made of an autoclave-sterilizable material.

11. The trial implant of claim 1, wherein the elongated central body has a height in the range of approximately 0.1 to 0.5 inch.

12. The trial implant of claim 1, wherein the elongated central body has a width in the range of approximately 0.2 to 0.5 inch.

13. The trial implant of claim 1, wherein the elongated central body has a maximum length in the range of approximately 0.3 to 1.7 inches.

14. The trial implant of claim 1, wherein the tab extends extending from one of the opposing end faces.

15. The trial implant of claim 14, further including:

a second tab extending from one of the opposing end faces opposite the first tab.

16. The trial implant of claim 14, wherein the tab forms a hole.

17. The trial implant of claim 16, wherein the retrieving means further includes a thread secured to the tab.

18. A trial implant for evaluating a size of a nucleus cavity portion of an intradiscal space, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the trial implant comprising:

an elongated body having a volume less than a volume of a nucleus cavity and being formed from a rigid, non-porous material; and

a tab associated with the elongated body for facilitating retrieval of the elongated body from a nucleus cavity.

wherein a combination of the elongated body and tab is sized to be encompassed by the anulus.

19. The trial implant of claim 18, wherein the elongated body has a size and shape corresponding with a size and shape of an available prosthetic spinal disc nucleus.

20. The trial implant of claim 18, wherein the elongated body is made of an inert material.

21. The trial implant of claim 18, wherein the elongated body is made of a low-friction material.

22. The trial implant of claim 18, wherein the elongated body is made of a tough material.

23. The trial implant of claim 18, wherein the elongated body is polyvinylideneflouride.

24. The trial implant of claim 18, wherein the trial implant is made of an autoclave-sterilizable material.

25. A kit for use in evaluating a size of a nucleus cavity for receiving a prosthetic spinal disc nucleus, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the kit comprising:

a container;

a first trial implant maintained within the container, the first trial implant being formed of a rigid, surgically safe material and having a predetermined size and shape related to a size and shape of a nucleus cavity; and

a second trial implant maintained within the container, the second trial implant being formed of a rigid, surgically safe material and having a predetermined size and shape, wherein the size of the first trial implant is different than the size of the second trial implant.

26. The kit of claim 25, wherein the shape of the second trial implant is different than the shape of the first trial implant.

27. The kit of claim 25, wherein the shape and size of the first trial implant corresponds with a shape and size of an available first prosthetic spinal disc nucleus.

28. The kit of claim 27, wherein the shape and size of the second trial implant corresponds with a shape and size of an available second prosthetic spinal disc nucleus.

29. The kit of claim 25, wherein the container includes first indicia associated with the first trial implant, the first indicia indicative of a characteristic of the first trial implant.

30. The kit of claim 25, wherein the container further includes second indicia associated with the second trial implant, the second indicia identifying a characteristic of the second trial implant.

31. The kit of claim 25, wherein the first trial implant and the second trial implant are made of an autoclave-sterilizable material.

32. The kit of claim 25, wherein the container is made of an autoclave-sterilizable material.

33. A method of evaluating a size of an intradiscal space for receiving a prosthetic spinal disc nucleus, the space including an intradiscal nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the method comprising:

creating an opening in the anulus to provide access to the nucleus cavity;

inserting a trial implant into the nucleus cavity through the opening, the trial implant being of a rigid, surgically safe material and having a predetermined size and shape;

attempting to position the trial implant within a desired area of the nucleus cavity;

determining whether the trial implant fits within the desired area of the nucleus cavity; and

removing the trial implant from the nucleus cavity.

34. The method of claim 33, wherein the size and shape of the trial implant correspond with a size and shape of an available prosthetic spinal disc nucleus.

35. The method of claim 33, wherein the desired area of the nucleus cavity is adjacent an anterior side of the anulus.

36. The method of claim 33, wherein the shape and size of the available prosthetic spinal disc nucleus dictates a desired orientation of the prosthetic spinal disc nucleus within the nucleus cavity upon implantation, and wherein attempting to position the trial implant includes:

maneuvering the trial implant to a position corresponding with the desired orientation.

37. The method of claim 33, wherein determining whether the trial implant fits within the desired portion includes:

evaluating whether the trial implant body is larger than the desired area of the nucleus cavity.

38. The method of claim 33, further including:

selecting the trial implant from a plurality of trial implants based upon an estimate of the size of the desired area, wherein each of the plurality of trial implants has a different size.

39. The method of claim 33, further including:

sterilizing the trial implant after removal from the nucleus cavity.

40. The method of claim 39, further including:

reusing the trial implant to evaluate a second nucleus cavity.