Systems and methods for internal bone fixation

• US 9,717,542 B2
• Filed: 11/07/2014
• Issued: 08/01/2017
• Est. Priority Date: 11/10/2006
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Drew, Mark A., Rabiner, Robert A.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US14/535,913
• Publication Number:
  US 20150066085A1
• Time in Patent Office: 998 Days
• Field of Search: 606 62, 606 63, 606 68, 606 92, 606 94, 606 93, 606246, 606300, 604 21, 623 2348, 623 2358
• 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. A device for repairing a bone comprising

a balloon portion releasably engaging a distal end of a delivery catheter;

and

an inner lumen of the delivery catheter engaging the balloon portion for permitting a light pipe to extend through the inner lumen into the balloon portion to guide light energy into the balloon portion to cure at least one reinforcing material curable by the light energy emitted from the light pipe while minimizing thermal egress of the light energy to surrounding tissue from 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,

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

2. The device of claim 1, wherein the bone is one of a weakened bone, a fractured bone or some combination thereof.

3. The device of claim 1, wherein the bone is selected from a group consisting of one of a metacarpal bone, femur, tibia, fibula, humerus, ulna, radius, metatarsals, phalanx, phalanges, ribs, spine, vertebrae or clavicle.

4. The device of claim 1, wherein the balloon portion is constructed to transit within the cavity of the bone.

5. The device of claim 1, wherein the balloon portion is configured to manipulate at least one obstruction, remove the at least one obstruction, or both.

6. The device of claim 1, wherein a substantial portion of an outer surface of the balloon portion while in the inflated state does not contact a wall of the cavity of the bone.

7. The device of claim 1, wherein the balloon portion does not extend through one or more hole, one or more crack or both, in the bone.

8. The device of claim 1, wherein the balloon portion includes one or more valves.

9. The device of claim 1, wherein a radiopaque bead is positioned at a distal end of the balloon portion for alignment of the device during fluoroscopy.

10. The device of claim 1, wherein a separation area is located at a junction between a distal end of a portion of the balloon portion and the elongated shaft and the separation area includes a length up to about 1 inch.

11. The device of claim 10, wherein the separation area includes an illumination band extending around the delivery catheter and having a stress concentrator.

12. The device of claim 11, wherein the stress concentrator includes one of a notched portion, a scored portion, an indented portion, a pre-weakened portion or a pre-stressed portion, to direct separation of the balloon portion from the elongated shaft of the delivery catheter.

13. The device of claim 1, wherein at least a portion of an outer surface of the balloon portion includes a textured surface, the textured surface including at least one of one or more rib, one or more ridge, at least one bump or some combination thereof.

14. A kit for repairing a weakened or fractured bone, the kit comprising:

a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween;

a balloon portion designed to releasably engage the delivery catheter;

at least one reinforcing material curable by light energy configured to pass through an inner void of the delivery catheter and into the balloon portion; and

a light pipe configured to extend through an inner lumen of the delivery catheter into the balloon portion to guide light energy into the balloon portion to cure the at least one reinforcing material, the inner lumen of the delivery catheter engaging the balloon portion to minimize thermal egress of light energy to surrounding tissue from 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.

15. The kit of claim 14, further comprising a light source for providing the light energy to the light pipe.

16. The kit of claim 14 further comprising an adapter to be releasably engaged to the proximal end of the delivery catheter for receiving the light pipe of a light source and the at least one reinforcing material.

17. The kit of claim 14, further comprising a plurality of balloon portions of varying sizes.

18. The kit of claim 14, further comprising a device for cutting the balloon portion from the delivery catheter.

19. A method for repairing a weakened or a fractured bone comprising:

positioning a balloon portion releasably engaging a delivery catheter within a cavity of the 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 of a light source to the balloon portion, the inner lumen engaging the balloon portion to minimize thermal egress of light energy to surrounding tissue from 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 through the inner lumen of the delivery catheter and into the balloon portion, to guide light energy emitted from the light pipe into the balloon portion to cure the light cure adhesive within the balloon portion.

20. The method of claim 19, further comprising determining a position of the balloon portion and an expansion of the balloon portion within the cavity of the bone by monitoring one or more radiopaque markers on the balloon portion.