Surgical trial implant

• US 20040019356A1
• Filed: 07/23/2002
• Published: 01/29/2004
• Est. Priority Date: 07/23/2002
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Depuy Spine Incorporated (Johnson & Johnson)
• Inventors: Boomer, Mark, Fraser, Robert
• Granted Patent: US 6,723,097 B2
• Time in Patent Office: Days
• US Class Current: 606/102
• CPC Class Codes: A61F 2/3094 Designing or manufacturing processes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• 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 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30115 circular-O-shaped
• CPC Class Codes: A61F 2002/30172 T-shaped
• CPC Class Codes: A61F 2002/30179 X-shaped
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30261 parallelepipedal
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0082 : parallelepipedal
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• 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 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00047 : Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures

Abstract

A trial implant and trial implant kit for assisting a physician in selecting an appropriately sized prosthesis is provided. In one embodiment, the trial medical implant device includes a body formed from a radio-lucent material and having a size and shape adapted to fit within or adjacent to an interstitial space, and at least one marker associated with the body and formed from a radio-opaque material. The at least one marker is configured to provide an x-ray visible reference to indicate the position and/or alignment of the body with respect to an anatomical structure when the trial medical implant device is positioned within an interstitial space.

Claims

1. A trial medical implant device, comprising:

a body formed from a radio-lucent material and having a size and shape adapted to fit within or adjacent to an interstitial space; and

at least one marker associated with the body and formed from a radio-opaque material, the at least one marker being configured to provide an x-ray visible reference to indicate the position and alignment of the body with respect to an anatomical structure when the trial medical implant device is positioned within an interstitial space.

2. The trial medical implant device of claim 1, further comprising a plurality of markers selectively positioned to intersect to form one or more reference points on the body.

3. The trial medical implant device of claim 1, wherein at least one of the markers is selectively distinguishable, on an x-ray image, from another one of the markers.

4. The trial medical implant device of claim 1, wherein the at least one marker has a shape selected from the group consisting of an elongate strip, a tube, a cross, a sphere, a plate, a ring, a rod, a T-shape, and combinations thereof.

5. The trial medical implant device of claim 1, wherein the at least one marker is disposed on an outer surface of the body or embedded in the body.

6. The trial medical implant device of claim 1, wherein at least one marker is disposed on an outer surface of the body and at least one marker is embedded in the body

7. The trial medical implant device of claim 1, wherein the body has a shape and size adapted to fit between adjacent vertebral bodies.

8. The trial medical implant device of claim 7, wherein the body is a disc-shaped member having a superior, bone-contacting surface and an inferior, bone-contacting surface, and wherein the at least one marker is effective to indicate the alignment of the superior and inferior bone-contacting surfaces of the body with respect to superior and inferior endplates of adjacent vertebral bodies when the implant is positioned between adjacent vertebral bodies.

9. The trial medical implant device of claim 1, wherein the body is formed from materials selected from the group consisting of polymers, ceramics, composite materials, and combinations thereof.

10. The trial medical implant device of claim 9, wherein the polymers are selected from the group consisting of polyether sulfone, polycarbonate, bioabsorbable polymers, carbon fiber reinforced polymers, and combinations thereof.

11. The trial medical implant device of claim 1, wherein the at least one marker is formed from a material selected from the group consisting of metals, polymers, filling salts, ceramics, and combinations thereof.

12. The trial medical implant device of claim 11, wherein the metals are selected from the group consisting of titanium, stainless steel, tantalum, cobalt chromium, aluminum, and combinations thereof.

13. A trial spinal implant, comprising:

a trial implant member formed from a radio-lucent material and having a size and shape configured to fit between adjacent vertebral bodies, the trial implant member including a superior bone-contacting surface and an inferior bone-contacting surface;

at least one marker formed from a radio-opaque material and associated with the trial implant member such that, when the trial implant is positioned between adjacent vertebral bodies, the at least one marker provides at least one x-ray visible reference to indicate the position of the implant member with respect to the adjacent vertebral bodies.

14. The trial spinal implant of claim 13, wherein the superior and inferior bone-contacting surfaces of the trial implant member each have a shape adapted to conform to an endplate of an adjacent vertebral body, and wherein the at least one marker indicates, on an x-ray image, the alignment of the superior and inferior bone-contacting surfaces of the trial implant member with respect to the endplates of adjacent vertebral bodies.

15. The trial spinal implant of claim 13, wherein the at least one marker is disposed on an outer surface of the trial implant member or is embedded in the trial implant member.

16. The trial spinal implant of claim 13, wherein at least one marker is disposed on an outer surface of the trial implant member and at least one marker is embedded in the trial implant member.

17. The trial spinal implant of claim 13, further comprising a plurality of markers selectively positioned to intersect to form one or more reference points on the trial implant member.

18. The trial spinal implant of claim 13, wherein the at least one marker has a shape selected from the group consisting of an elongate strip, a tube, a cross, a sphere, a plate, a ring, a rod, a T-shape, and combinations thereof.

19. The trial spinal implant of claim 13, wherein the trial implant member is formed from materials selected from the group consisting of polymers, ceramics, composite materials, and combinations thereof.

20. The trial spinal implant of claim 19, wherein the polymers are selected from the group consisting of polyether sulfone, polycarbonate, bioabsorbable polymers, carbon fiber reinforced polymers, and combinations thereof.

21. The trial spinal implant of claim 13, wherein the at least one marker is formed from a material selected from the group consisting of metals, polymers, filling salts, ceramics, and combinations thereof.

22. The trial spinal implant of claim 21, wherein the metal is selected from the group consisting of titanium, stainless steel, tantalum, cobalt chromium, aluminum, and combinations thereof.

23. A trial implant system, comprising:

a plurality of implantable trial prostheses, each implantable prosthesis comprising

a body formed from a radio-lucent material and having a size and shape adapted to fit within or adjacent to an anatomical structure, and

at least one marker associated with the body and formed from a radio-opaque material, the at least one marker being configured to provide an x-ray visible reference to indicate the position and alignment of the body with respect to the anatomical structure when the implantable trial prosthesis is positioned within an anatomical structure.

24. The trial implant system of claim 23, wherein the body of each implantable trial prosthesis includes superior and inferior bone-contacting surfaces, each having a shape adapted to conform to an endplate of a vertebral body, and wherein the at least one marker indicates, on an x-ray image, the alignment of the superior and inferior bone-contacting surfaces of the body with respect to the endplates of adjacent vertebral bodies when the implantable trial prosthesis is positioned within an anatomical structure.

25. The trial implant system of claim 23, wherein the at least one marker is disposed on an outer surface of the body or is embedded in the body.

26. The trial implant system of claim 23, wherein at least one marker is disposed on an outer surface of the body and at least one marker is embedded in the body.

27. The trial implant system of claim 23, further comprising a plurality of markers selectively positioned to intersect to form one or more reference points on the body.

28. The trial implant system of claim 23, wherein the at least one marker has a shape selected from the group consisting of an elongate strip, a tube, a cross, a sphere, a plate, a ring, a rod, a T-shape, and combinations thereof.

29. The trial implant system of claim 23, wherein the body is formed from materials selected from the group consisting of polymers, ceramics, composite materials, and combinations thereof.

30. The trial implant system of claim 29, wherein the polymers are selected from the group consisting of polyether sulfone, polycarbonate, bioabsorbable polymers, carbon fiber reinforced polymers, and combinations thereof.

31. The trial implant system of claim 23, wherein the at least one marker is formed from a material selected from the group consisting of metals, polymers, filling salts, ceramics, and combinations thereof.

32. The trial implant system of claim 31, wherein the metal is selected from the group consisting of titanium, stainless steel, tantalum, cobalt chromium, aluminum, and combinations thereof.

33. A method for manufacturing a trial implant, comprising:

providing at least one marker formed from a radio-opaque material;

providing a mold for a medical implant, the mold having a desired size and shape;

strategically placing each of the at least one markers in the mold such that the markers are configured to provide at least one x-ray visible reference to indicate the size and shape of the medical implant; and

injecting a radio-lucent material into the mold to form a trial implant.