Methods for positioning a load-bearing orthopedic implant device in vivo

• US 20080154266A1
• Filed: 12/21/2006
• Published: 06/26/2008
• Est. Priority Date: 12/21/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Sherman, Michael C., Justis, Jeff R., Trieu, Hai H., Protopsaltis, Dimitri
• Granted Patent: US 8,758,407 B2
• Time in Patent Office: Days
• US Class Current: 606/76
• 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 17/7035 Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
• CPC Class Codes: A61B 17/7059 Cortical plates A61B17/7007, A61B17/7058 take precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00831 Material properties
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3009 Transparent or translucent
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• 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 2002/4692 : fluid
• 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 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2250/0091 : transparent or translucent

Abstract

Orthopedic implant devices are positioned at a desired in vivo site by positioning a device that is non-rigid, i.e., flexible and/or malleable, in a first form, and then transformable after insertion to the in vivo site 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 application of a quantity of an initiating energy to the material.

Claims

1. A method for positioning a load-bearing component of an orthopedic implant, comprising:

providing a malleable device, the device including a biocompatible sheath and a curable material sealed within the sheath, the device having a non-rigid form and being transformable to a rigid form after application of a quantity of an initiating energy to the material effective to cure the material;

inserting the device to an in vivo location where the provision of load-bearing functionality is desired; and

applying a dose of the initiating energy to the material.

2. The method in accordance with claim 1 wherein the device is deformable before and during said inserting.

3. The method in accordance with claim 1, further comprising, before said inserting, shaping the device into a compacted configuration for delivery to the in vivo location.

4. The method in accordance with claim 1, further comprising, after said inserting, forming the device to a desired shape and a desired orientation relative to a bony portion.

5. The method in accordance with claim 1, further comprising, after said applying, maintaining the malleable device in the desired orientation for a period of time sufficient for the curable material to harden, thereby forming a load-bearing component of an orthopedic implant

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

7. The method in accordance with claim 1 wherein said providing comprises removing the device from a sealed package.

8. The method in accordance with claim 7 wherein the package is sterilized.

9. The method in accordance with claim 1 wherein said inserting comprises shaping the device into a compacted form, placing the device at the in vivo location, and then reforming the device into an expanded form that is larger than the compacted form in at least one dimension.

10. The method in accordance with claim 9 wherein said shaping comprises folding, and wherein said reforming comprises unfolding.

11. The method in accordance with claim 9 wherein said shaping comprises flexing.

12. The method in accordance with claim 1 wherein the dose of initiating energy is effective to effect partial curing of the material.

13. The method in accordance with claim 12, further comprising, after said applying, re-shaping the partially cured device and applying a second dose of initiating energy to complete curing of the material.

14. The method in accordance with claim 1 wherein said applying comprises exposing the curable material to the initiating energy for a time period of from about 1 second to about 30 minutes.

15. The method in accordance with claim 1 wherein, after said applying, the device has a working time prior to fully transforming to the rigid form of from about 1 minute to about 60 minutes

16. The method in accordance with claim 1 wherein, after said applying, the device has a working time prior to fully transforming to the rigid form of at least about 2 minutes.

17. The method in accordance with claim 1 wherein the material includes a single component epoxy.

18. The method 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.

19. The method in accordance with claim 18, 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.

20. The method in accordance with claim 1 wherein the sheath is structured to transmit the initiating energy therethrough.

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

22. The method in accordance with claim 18 wherein said mechanical energy is ultrasonic energy.

23. The method in accordance with claim 1 wherein the device, upon transformation of the material to the rigid form, becomes a load-bearing component selected from the group consisting of a spinal rod, a plate, a spacer, a bone screw, an anchor, an artificial disk and a nucleus implant.

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

C. to about 70°

C.

25. The method in accordance with claim 1 wherein the sheath comprises a bioresorbable material.

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

27. The method in accordance with claim 1 wherein the device further comprises a reinforcement member contained within the sheath to provide additional strength after curing.

28. The method in accordance with claim 27 wherein the reinforcement member is a structural matrix material.

29. The method in accordance with claim 27 wherein the matrix material comprises a carbon fiber matrix.

30. The method in accordance with claim 1 wherein the device comprises a pressurizeable balloon positioned within the sheath and having a fluid-infusing port passing through the sheath;

and wherein the method further comprises, before the curable material is hardened, infusing a fluid into the balloon to pressurize the balloon, thereby increasing the size of the device in at least one dimension.

31. A method for positioning a load-bearing orthopedic implant, comprising:

positioning in an in vivo position a malleable device including a curable material contained within a biocompatible sheath and an energy delivery element contained within the sheath; and

initiating curing of the curable material by exposing the curable material to a quantity of initiating energy from the energy delivery element effective to initiate curing.

32. The method in accordance with claim 31 wherein the energy delivery element comprises an electromagnetic radiation delivery element.

33. The method in accordance with claim 32 wherein the sheath comprises an internal surface oriented toward the curable material, and wherein the internal surface is effective to reflect at least a portion of the electromagnetic radiation.

34. The method in accordance with claim 32 wherein the element is a fiber optic element.

35. The method in accordance with claim 32, further comprising connecting a source of electromagnetic radiation to the delivery element.

36. The method in accordance with claim 31 wherein the energy delivery element is formed as a coil in the material.

37. The method in accordance with claim 31 wherein the energy delivery element comprises at least one link passing through the sheath for connection to an external energy source.

38. The method in accordance with claim 37 wherein the curable material comprises a photocurable composition, wherein the energy delivery element comprises a fiber optic element, and wherein the sheath includes at least one light portal for transmitting light into the fiber optic cable.

39. The method in accordance with claim 31 wherein the device further comprises a plurality of energy delivery members positioned within the sheath.

40. A method for positioning a load-bearing orthopedic implant, comprising:

positioning in an in vivo position a malleable device including a biocompatible sheath and a curable material contained therein that is hardenable by exposing the curable material to a quantity of initiating energy effective to fully cure the material, wherein the initiating energy is electromagnetic radiation of a predetermined wavelength, and wherein the sheath is translucent or transparent to the radiation; and

initiating curing of the curable material by passing radiation of the predetermined wavelength through the sheath to expose the curable material to a dose of initiating energy effective to initiate curing.

41. A method for positioning a load-bearing orthopedic implant, comprising:

positioning in an in vivo position a malleable device including a biocompatible sheath and, contained within the sheath, a pressurizeable balloon and a curable material positioned external to the balloon;

introducing a pressurizing fluid into the balloon to pressurize the balloon and exert an outward pressure on the curable material and the sheath, thereby causing the device to engage adjacent structures; and

initiating curing of the curable material by exposing the curable material to a dose of initiating energy effective to initiate curing.