Systems and Methods for Internal Bone Fixation

• US 20130184715A1
• Filed: 12/28/2012
• Published: 07/18/2013
• 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.
• Granted Patent: US 8,906,031 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• 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 balloon portion releasably engaging a distal end of a delivery catheter, wherein an inner lumen of the delivery catheter connects to the balloon portion to guide light energy from a light source into the balloon portion;

at least one reinforcing material curable by the light energy emitted from the light source; and

one or more radiopaque markers positioned on the balloon portion,

wherein the balloon portion is configured to move from a deflated state to an inflated state when the at least one reinforcing material is added into the balloon portion, and

wherein the balloon portion is configured for placement into an inner cavity of a bone.

2. The internal bone fixation device of claim 1 wherein the light source includes a light pipe for emitting energy into the balloon portion.

3. The internal bone fixation device of claim 1 further comprising a light pipe to deliver the light energy into the balloon portion to minimize thermal egress of the light energy from the balloon portion to supporting tissue.

4. The internal bone fixation device of claim 1 wherein the balloon portion is constructed from a polymer material.

5. The internal bone fixation device of claim 1 wherein the inner lumen of the delivery catheter directly connects to the balloon portion.

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

7. The internal bone fixation device of claim 6 wherein the balloon portion 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.

8. The internal bone fixation device of claim 7 wherein the balloon portion conforms to at least a portion of a wall of the inner cavity of the at least two bone fragments when in the inflated state.

9. The internal bone fixation device of claim 1 further comprising a separation area positioned at a junction between the balloon portion and the delivery catheter.

10. The internal bone fixation device of claim 1 further comprising a stress concentrator located between the balloon portion and the delivery catheter to separate the balloon portion from the delivery catheter.

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

a light cure adhesive;

a light pipe;

a delivery catheter having an elongated shaft with a distal end and a proximal end, the delivery catheter having 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, and the balloon portion having a textured outer surface,

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 energy into the balloon portion to harden the light cure adhesive within the balloon portion.

12. The system of claim 11 wherein the light pipe delivers the light energy into the balloon portion to minimize thermal egress of the light energy from the balloon portion to supporting tissue.

13. The system of claim 11 wherein the inner lumen of the delivery catheter directly connects to the balloon portion.

14. The system of claim 11 for use in repairing a bone fractured into at least two bone fragments.

15. The system of claim 11 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.

16. The system of claim 11 wherein the balloon portion is configured to contact a wall of an inner cavity of at least two bone fragments when the balloon portion is used in repairing a fractured bone.

17. The system of claim 11 wherein an ultraviolet light cures the light cure adhesive.

18. The system of claim 11 wherein a visible light cures the light cure adhesive.

19. The system of claim 11 further comprising an imaging device for monitoring expansion of the balloon portion.

20. The system of claim 11 further comprising one or more radiopaque markers positioned on the balloon portion.

21. The system of claim 20 wherein the one or more radiopaque markers on the balloon portion provide a visibility of the balloon portion while using an imaging device to determine a position of the balloon portion during placement and expansion of the balloon portion in a fractured bone.

22. The system of claim 11 further comprising a plurality of ridges extending from the textured outer surface of the balloon portion to conform the balloon portion to a shape of a bone cavity.

23. The system of claim 11 wherein the 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.

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

positioning a balloon portion releasably engaging a delivery catheter within an inner cavity of a fractured bone, 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;

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

delivering light energy through the light pipe to cure the light cure adhesive.

25. The method of claim 24 further comprising delivering the light energy from the light pipe into the balloon portion to minimize thermal egress of the light energy from the balloon portion to supporting tissue.

26. The method of claim 24 further comprising determining a position of the balloon portion and an expansion of the balloon portion within the inner cavity of the fractured bone by monitoring one or more radiopaque markers on the balloon portion.