Curable orthopedic implant devices configured to harden after placement in vivo by application of a cure-initiating energy before insertion

• US 7,771,476 B2
• Filed: 12/21/2006
• Issued: 08/10/2010
• Est. Priority Date: 12/21/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Protopsaltis, Dimitri, Sherman, Michael C., Justis, Jeff R., Trieu, Hai H.
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): NEGRELLI, CHRISTINA L
• Application Number:
  US11/643,489
• Publication Number:
  US 20080154368A1
• Time in Patent Office: 1,328 Days
• Field of Search: 606/60, 606/61, 606/192, 606/62, 623/11.11, 623 1711- 1716, 623/13.15
• US Class Current: 623/17.11
• CPC Class Codes: A61B 17/7013 the shape of the element being adjustable before use adjustable length plates A61B17/7014
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7049 Connectors, not bearing on the vertebrae, for linking longitudinal elements together A61B17/7055, A61B17/7053, A61B17/7019 take precedence
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/8605 Heads, i.e. proximal ends projecting from bone
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/866 Material or manufacture
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4425 made of articulated components
• 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 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/444 : for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• CPC Class Codes: A61F 2002/465 : using heating means
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter

Abstract

An orthopedic implant device is non-rigid, i.e., flexible and/or malleable, in a first form for insertion into a desired in vivo site, and then transformable into a rigid, or hardened, form for providing a load-bearing function or providing other structural and/or mechanical function after implant. The device includes a biocompatible sheath and a curable material sealed within the sheath. The curable material is provided in a first form that provides flexibility to the device and is structured to rigidize in a second form after insertion to an in vivo location as a result of application of a cure-initiating energy to the material prior to insertion. Related methods and kits are also provided.

Claims

1. An orthopedic implant device, comprising:

a biocompatible sheath;

a curable material having a non-rigid form contained and sealed in the sheath;

wherein the device is deformable before and during implantation within a patient;

wherein the curable material is transformable to a rigid form after application of a quantity of an initiating energy to the material effective to cure the material;

wherein the curable material exhibits a working time of at least 1 minute after application of the initiating energy and prior to fully transforming to the rigid form; and

a pressurizeable balloon positioned within the sheath and having a fluid-infusing port passing through the sheath, the pressurizing balloon operable, before the curable material is hardened, to receive a fluid to pressurize the balloon, thereby increasing the size of the device in at least one dimension, wherein, upon curing, the device becomes a bone anchor and wherein the bone anchor includes a bone engaging portion opposite a head portion, the bone engaging portion being structured to engage bony tissue and the head portion being structured to engage an elongate implant element, wherein the sheath extends along the bone engaging portion.

2. The device in accordance with claim 1, wherein the bone engaging portion comprises an elongate stem and wherein the head portion is moveable relative to the stem.

3. The device in accordance with claim 1 wherein the device is sterilized.

4. The device in accordance with claim 1, further comprising a package;

and wherein the device is contained within the package.

5. The device in accordance with claim 4, wherein the device and the package are sterilized.

6. The device in accordance with claim 1, wherein after application of the initiating energy, the device has a working time prior to fully transforming to the rigid form of about 1 minute to about 60 minutes.

7. The device in accordance with claim 1, wherein, after application of the initiating energy, the device has a working time prior to fully transforming to the rigid form of at least about 2 minutes.

8. The device in accordance with claim 1, wherein the curable material includes a single component epoxy.

9. The device in accordance with claim 1, wherein the initiating energy is selected from the group consisting of electromagnetic radiation, thermal energy, electrical energy, chemical energy and mechanical energy.

10. The device in accordance with claim 9, wherein the electromagnetic radiation is selected from the group consisting of visible light, ultraviolet light, infrared light, gamma radiation, X-ray radiation and radio frequency radiation.

11. The device in accordance with claim 1, wherein the sheath is structured to transmit the initiating energy therethrough.

12. The device in accordance with claim 1, wherein the sheath is composed of a self-sealing material, and wherein said initiating energy comprises injecting into the curable material a dose of a chemical initiator effective to initiate curing.

13. The device in accordance with claim 1, wherein the curing is achieved at a temperature of from about 20°

C. to about 70°

C.

14. The device in accordance with claim 1, wherein the sheath comprises a material selected from the group consisting of polyethylene, polyester, polyamide, polyurethane, silicone, polyetheretherketone, polyacrylate, polylactide and polyglycolide.

15. The device in accordance with claim 1, wherein the sheath comprises a bioresorbable material.

16. The device in accordance with claim 1, further comprising a reinforcement member contained within the sheath to provide additional strength after curing.

17. The device in accordance with claim 16, wherein the reinforcement member is a structural matrix material.

18. The device in accordance with claim 16 wherein the matrix material comprises carbon fiber.

19. The device in accordance with claim 1, further comprising a plurality of connectors passing through the sheath.

20. An orthopedic implant device, comprising:

a biocompatible sheath;

a curable material contained within the sheath, the curable material operable, upon application of a cure-initiating energy, to harden, thereby forming a load-bearing component of an orthopedic implant, and wherein the curable material exhibits a working time of at least 1 minute after application of the energy and prior to fully transforming to the rigid form; and

an energy delivery element contained within the sheath, the energy delivery element comprising a fiber optic element operable to deliver initiating energy to the curable material.

21. The device in accordance with claim 20, wherein the device is sterilized.

22. The device in accordance with claim 20, further comprising a package;

and wherein the device is contained within the package.

23. The device in accordance with claim 22, wherein the device and the package are sterilized.

24. The device in accordance with claim 20, wherein after application of the initiating energy, the device has a working time prior to fully transforming to the rigid form of about 1 minute to about 60 minutes.

25. The device in accordance with claim 20, wherein, after application of the initiating energy, the device has a working time prior to fully transforming to the rigid form of at least about 2 minutes.

26. The device in accordance with claim 20, wherein the initiating energy is electromagnetic radiation.

27. The device in accordance with claim 26, wherein the electromagnetic radiation is visible light, ultraviolet light, or infrared light.

28. The device in accordance with claim 20, wherein the curing is achieved at a temperature of from about 20°

C. to about 70°

C.

29. The device in accordance with claim 20, wherein the sheath comprises a material selected from the group consisting of polyethylene, polyester, polyamide, polyurethane, silicone, polyetheretherketone, polyacrylate, polylactide and polyglycolide.

30. The device in accordance with claim 20, wherein the sheath comprises a bioresorbable material.

31. The device in accordance with claim 20, further comprising a reinforcement member contained within the sheath to provide additional strength after curing.

32. The device in accordance with claim 31, wherein the reinforcement member is a structural matrix material.

33. The device in accordance with claim 31, wherein the matrix material comprises carbon fiber.

34. The device in accordance with claim 20, further comprising a plurality of fiber optic elements passing through the sheath.