Systems and Methods for Internal Bone Fixation

• US 20170311996A1
• Filed: 07/17/2017
• Published: 11/02/2017
• 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 10,543,025 B2
• Time in Patent Office: Days
• 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 such that a light energy can be delivered to the balloon portion to cure at least one reinforcing material curable by the light energy;

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 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.

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

4. 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.

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

6. 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.

7. 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.

8. The device of claim 7, wherein the separation area includes an illumination band extending around the delivery catheter and having a stress concentrator.

9. The device of claim 1, wherein the inner lumen of the delivery catheter is configured to engage the balloon portion to minimize thermal egress of the light energy to surrounding tissue from the balloon portion.

10. The device of claim 1, further comprising an optical rod configured to extend through the inner lumen of the delivery catheter to guide the light energy into the balloon portion.

11. 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

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, the reinforcing material being curable by a light energy delivered through the catheter to the balloon.

12. The kit of claim 11, further comprising a light source for providing the light energy to a light pipe configured to extend through an inner lumen of the delivery catheter into the balloon portion to guide the light energy into the balloon portion to cure the reinforcing material.

13. The kit of claim 12, further comprising an adapter to be releasably engaged to the proximal end of the delivery catheter for receiving the light pipe and the at least one reinforcing material.

14. The kit of claim 11, further comprising a plurality of balloon portions of varying sizes.

15. The kit of claim 11, further comprising a device for cutting the balloon portion from the delivery catheter.

16. The kit of claim 11, wherein the inner lumen of the delivery catheter is configured to engage the balloon portion to minimize thermal egress of the light energy to surrounding tissue from the balloon portion.

17. 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 energy 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;

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

18. The method of claim 17, 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.

19. The method of claim 17, wherein the inner lumen engages the balloon portion to minimize thermal egress of light energy to surrounding tissue from the balloon portion.

20. The method of claim 17, further comprising inserting an optical rod through the inner lumen of the delivery catheter and into the balloon portion to guide the light energy therein.