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

• US 20080154368A1
• 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 7,771,476 B2
• Time in Patent Office: Days
• US Class Current: 623/11.11
• 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; and

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, and exhibits a working time of at least 1 minute after application of the energy and prior to fully transforming to the rigid form.

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

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

and wherein the device is contained within the package.

4. The device in accordance with claim 3, wherein the device and the package are sterilized.

5. 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 from about 1 minute to about 60 minutes

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 at least about 2 minutes.

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

8. 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.

9. The device in accordance with claim 8 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.

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

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

12. The device in accordance with claim 1 wherein, after curing, the device becomes a member 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.

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 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.

20. The device in accordance with claim 19 wherein, upon curing, the device becomes a bone anchor.

21. The device in accordance with claim 20 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.

22. The device in accordance with claim 21 wherein the sheath extends along the bone engaging portion.

23. The device in accordance with claim 21 wherein the bone engaging portion comprises an elongate stem and wherein the head portion is moveable relative to the stem.

24. The device in accordance with claim 20, the bone anchor operable to engage at least one anchor-retaining surface provided in a cavity formed in a bony portion when the balloon is inflated.

25. The device in accordance with claim 19 wherein, upon curing, the device becomes a member selected from an interbody device and a spinal rod.

26. The device in accordance with claim 19 wherein the device is selected from an interbody device that is operable to movably support the vertebrae and an interbody fusion device.

27. 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 operable to deliver initiating energy to the curable material.

28. The device in accordance with claim 27 wherein the energy delivery element comprises an electromagnetic radiation delivery element, 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.

29. The device in accordance with claim 27 wherein the element comprises a fiber optic element.

30. The device in accordance with claim 27 wherein the energy delivery element is selected from the group consisting of a heating element, an antenna, an electrical element, and a fiber optic element.

31. The device in accordance with claim 27 wherein the energy delivery element is formed as a coil in the material.

32. The device in accordance with claim 27 wherein the energy delivery element comprises at least one connector passing through the sheath for connection to an external energy source.

33. The device in accordance with claim 32 wherein the curable material comprises a photocurable composition, wherein the energy delivery element comprises a fiber optic element, and wherein the device includes at least one connector for transmitting light into the fiber optic cable.

34. The device in accordance with claim 27 wherein the device further comprises a plurality of energy delivery members positioned within the sheath.

35. The device in accordance with claim 34, further comprising a plurality of connectors passing through the sheath.

36. An orthopedic implant device, comprising:

a biocompatible sheath; and

a curable material contained within the biocompatible sheath, the curable material operable, upon application of a quantity of a cure-initiating energy, to harden, thereby forming a load-bearing component of an orthopedic implant;

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;

wherein the initiating energy is electromagnetic radiation of a predetermined wavelength; and

wherein the sheath is transparent to the radiation.

37. An orthopedic implant device, comprising:

a biocompatible sheath;

a pressurizeable balloon contained within the sheath; and

a curable material contained within the sheath external to the balloon, the curable material operable, upon application of a quantity of a cure-initiating energy, to harden, thereby forming a load-bearing component of an orthopedic implant;

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

wherein the balloon is operable to receive a pressurizing fluid to pressurize the balloon and exert an outward pressure on the curable material and the sheath.

38. The device in accordance with claim 37 wherein the device is operable to be formed by introducing a pressurizing fluid into the balloon to pressurize the balloon and exert an outward pressure on the curable material and the sheath.

39. The device in accordance with claim 37 wherein, upon curing, the device becomes a bone anchor or an interbody device.

40. The device in accordance with claim 37 wherein the device is selected from an interbody device that is operable to movably support the vertebrae and an interbody fusion device.