Systems and methods for internal bone fixation

• US 8,366,711 B2
• Filed: 08/18/2010
• Issued: 02/05/2013
• Est. Priority Date: 11/10/2006
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A., Drew, Mark A.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/858,924
• Publication Number:
  US 20110004213A1
• Time in Patent Office: 902 Days
• Field of Search: 606/192, 606/60, 606/1, 606/105, 606190-197, 606/86.A, 606/63, 606/93, 606/92, 606/94, 606/62, 606/68, 604/21
• US Class Current: 606/63
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/7291 for small bones, e.g. in the foot, ankle, hand or wrist
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence

Abstract

Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. A device for use in repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of at least one reinforcing material and an inner lumen for passage of a light source; a conformable member releasably engaging the distal end of the delivery catheter, wherein the conformable member moves from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light source and the at least one reinforcing material.

Claims

1. An internal bone fixation device comprising:

a conformable member engaging a distal end of a delivery catheter, wherein an inner lumen of the delivery catheter connects to the conformable member to guide light energy from a light source into the conformable member to minimize thermal egress of the light energy to supporting tissue from the conformable member; and

at least one reinforcing material contained within the conformable member, wherein the conformable member moves from a deflated state to an inflated state when the at least one reinforcing material is added to the conformable member, and

wherein the at least one reinforcing material is hardened by the light energy emitted from the light source.

2. The internal bone fixation device of claim 1 wherein the conformable member is constructed from a polymer material.

3. The internal bone fixation device of claim 1 for use in repairing a bone fractured into at least two bone fragments.

4. The internal bone fixation device of claim 3 wherein the conformable member resides within an inner cavity of the at least two bone fragments and provides support to the at least two bone fragments to promote healing.

5. The internal bone fixation device of claim 4 wherein the conformable member evenly contacts a wall of the inner cavity of the at least two bone fragments when in the inflated state.

6. The internal bone fixation device of claim 1 wherein the light source includes a light pipe and an optical lens.

7. The internal bone fixation device of claim 1 wherein the light source includes a light pipe that emits energy through an optical lens and guides the light energy into the conformable member.

8. The internal bone fixation device of claim 1 wherein the inner lumen of the delivery catheter directly connects to the conformable member.

9. An internal bone fixation device comprising:

at least a portion of a distal end of a delivery catheter;

a balloon portion engaging the distal end of the delivery catheter wherein an inner lumen of the delivery catheter connects to the balloon portion to guide a visible light into the balloon portion to harden a light cure adhesive within the balloon portion and to minimize thermal egress of the visible light to supporting tissue from the balloon portion; and

a hardened light cure adhesive within the balloon portion, wherein the hardened light cure adhesive has been cured by the visible light.

10. The internal bone fixation device of claim 9 wherein the balloon portion is constructed from a polymer material.

11. The internal bone fixation device of claim 9 for use in repairing a bone fractured into at least two bone fragments.

12. The internal bone fixation device of claim 9 wherein the balloon portion resides within an inner cavity of at least two bone fragments when the balloon portion is used in repairing a fractured bone.

13. The internal bone fixation device of claim 9 wherein the balloon portion evenly contacts a wall of an inner cavity of at least two bone fragments when the balloon portion is used in repairing a fractured bone.

14. The internal bone fixation device of claim 9 wherein the hardened light cure adhesive has been cured by the visible light emitted from a light source comprising a light pipe and an optical lens.

15. The device of claim 9 further comprising a plurality of ribs extending from an outer surface of the balloon portion to conform the balloon portion to a shape of a bone cavity.

16. The device of claim 9 wherein an outer surface of the balloon portion is textured.

17. The device of claim 9 wherein a textured outer surface of the balloon portion interacts with bone fragments for adhesion between the bone fragments and the textured outer surface to promote the formation of new bone onto the textured outer surface.

18. The internal bone fixation device of claim 9 wherein the inner lumen of the delivery catheter directly connects to the balloon portion.

19. A system for internal fixation of a fractured bone comprising:

a light cure adhesive curable by exposure to visible light;

a delivery catheter having an elongated shaft with a distal end and a proximal end for accepting a light pipe and the light cure adhesive, wherein the delivery catheter has an inner void for passage of the light cure adhesive and an inner lumen for passage of the light pipe; and

a balloon portion releasably engaging the distal end of the delivery catheter,

wherein the balloon portion expands from a deflated state to an inflated state when the light cure adhesive is delivered through the inner void of the delivery catheter into the balloon portion, and

wherein the inner lumen of the delivery catheter connects to the balloon portion to guide the light into the balloon portion to harden the light cure adhesive within the balloon portion and to minimize thermal egress of the light to supporting tissue from the balloon portion.

20. The system of claim 19 for use in repairing a bone fractured into at least two bone fragments.

21. The system of claim 19 wherein the balloon portion resides within an inner cavity of at least two bone fragments when the balloon portion is used in repairing a fractured bone.

22. The system of claim 19 wherein the balloon portion evenly contacts a wall of an inner cavity of at least two bone fragments when the balloon portion is used in repairing a fractured bone.

23. The system of claim 19 wherein the light cure adhesive is an ultraviolet adhesive.

24. The system of claim 19 further comprising an imaging device for monitoring expansion of the balloon portion.

25. The system of claim 24 further comprising one or more radiopaque markers positioned on the balloon portion.

26. The system of claim 25 wherein the one or more radiopaque markers on the balloon portion provide a visibility of the balloon portion while using the imaging device to determine a position of the balloon portion during placement and expansion of the balloon portion in a fractured bone.

27. The system of claim 19 further comprising a light pipe.

28. The system of claim 19 further comprising a light pipe that emits the light through an optical lens and guides the light into the balloon portion.

29. The system of claim 19 further comprising a plurality of ridges extending from an outer surface of the balloon portion to conform the balloon portion to a shape of a bone cavity.

30. The system of claim 19 wherein an outer surface of the balloon portion is textured.

31. The system of claim 19 wherein a textured outer surface of the balloon portion interacts with bone fragments for adhesion between the bone fragments and the textured outer surface to promote the formation of new bone onto the textured outer surface.

32. The system of claim 19 wherein the inner lumen of the delivery catheter directly connects to the balloon portion.

33. A method for internal fixation of a fractured bone comprising:

gaining access to an internal space within the fractured bone;

providing a device comprising a balloon portion engaging a delivery catheter, wherein the delivery catheter has an inner void for passage of a light cure adhesive to the balloon portion and an inner lumen for passage of a light pipe to the balloon portion, and wherein the balloon portion includes one or more radiopaque markers;

positioning the balloon portion of the device within the internal space of the fractured bone;

expanding the balloon portion by infusion of the light cure adhesive into the inner void of the delivery catheter and into the balloon portion;

using an imaging device to determine a position of the balloon portion and an expansion of the balloon portion within the internal space of the fractured bone by visibly monitoring the one or more radiopaque markers on the balloon portion;

inserting the light-pipe into the inner lumen of the delivery catheter and towards the balloon portion, wherein the inner lumen connects to the balloon portion to guide the light from the light pipe into the balloon portion to cure the light cure adhesive within the balloon portion and to minimize thermal egress of the light to supporting tissue from the balloon portion; and

activating the light pipe to cure the light cure adhesive.

34. The method of claim 33 wherein the inner lumen of the delivery catheter directly connects to the balloon portion.