Apparatus for delivery of reinforcing materials to bone

• US 9,265,549 B2
• Filed: 01/27/2014
• Issued: 02/23/2016
• Est. Priority Date: 04/26/2006
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A.
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US14/164,846
• Publication Number:
  US 20140142581A1
• Time in Patent Office: 757 Days
• Field of Search: 606/62, 606/63, 606/13, 606 92- 95, 606/108, 606/192, 600/101, 600/116, 600/178
• US Class Current: 1/1
• 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 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 17/8897 Guide wires or guide pins
• CPC Class Codes: A61B 2017/564 Methods for bone or joint treatment
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure

Abstract

An apparatus and methods for delivery of reinforcing materials to a weakened or fractured bone is disclosed. An apparatus for delivering a reinforcing mixture to a bone including a tube having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the tube has at least one inner lumen capable of allowing a bone reinforcing mixture to pass therethrough; a balloon engaging the tube wherein the balloon expands from a substantially deflated state to a substantially inflated state upon the bone reinforcing mixture entering the balloon; and at least one light guide extending through the tube into the balloon to guide a light into the balloon.

Claims

1. A system for delivering a bone reinforcing mixture to a fractured bone or a weakened bone comprising:

a catheter having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the catheter has at least one inner lumen for passing a bone reinforcing mixture therethrough;

a balloon engaging the distal end of the catheter;

a bone reinforcing mixture contained in the balloon when the balloon is in a cavity of the bone;

at least one light guide extending through the catheter into the balloon to guide a light into the balloon to illuminate and cure the bone reinforcing mixture contained in the balloon; and

a device engaging the balloon containing the cured bone reinforcing mixture.

2. The system of claim 1, wherein the device provides support for compression and torsion of the balloon in the cavity of the bone.

3. The system of claim 1, wherein the device is a screw.

4. The system of claim 1, wherein the device is a plate.

5. The system of claim 1, wherein the device is a pin.

6. The system of claim 1, wherein inflation of the balloon within the cavity of the bone provides for an even dispersion of radial force.

7. The system of claim 1, wherein an outer surface of the balloon is preformed to be contained within the cavity of the fractured bone or the weakened bone.

8. The system of claim 1, wherein the balloon comprises a plurality of layers.

9. The system of claim 1, wherein the balloon has an outer surface that is substantially smooth.

10. The system of claim 1, wherein the balloon has an outer surface that is textured.

11. The system of claim 1, wherein the balloon has an outer surface that includes ribs, ridges, or bumps.

12. The system of claim 1, further comprising a light source that provides ultraviolet light or visible light to the catheter.

13. The system of claim 1, further comprising an outer balloon surrounding the balloon.

14. The system of claim 13, wherein the outer balloon has a different durometer than the balloon.

15. The system of claim 13, wherein the outer balloon is softer than the balloon.

16. The system of claim 1, further comprising an illumination band located at a junction between the catheter and the balloon.

17. The system of claim 1, further comprising a separation area on the distal end of the catheter to separate the catheter from the balloon.

18. The system of claim 17, wherein the separation area is an illumination band.

19. The system of claim 18, wherein the illumination band, when activated, causes light to cure the bone reinforcing material located in the catheter within the illumination band.

20. The system of claim 1, wherein an illumination band extends around the catheter and includes a stress concentrator for separating the balloon from the catheter.

21. The system of claim 20, wherein the stress concentrator is from the group consisting of a notch, a groove, a score, an indented portion, a pre-weakened portion, a pre-stressed portion and a channel.

22. The system of claim 1, wherein the bone is from the group consisting of a radius, an ulna, a clavicle, a metacarpal, a phalanx, a metatarsal, a phalange, a tibia, a fibula, a humerus, a spine, a rib and a vertebra.

23. A system for delivering a bone reinforcing mixture to a fractured bone or a weakened bone comprising:

a catheter having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the catheter has at least one inner lumen for passing a bone reinforcing mixture therethrough;

a balloon engaging the distal end of the catheter, wherein the balloon expands from a substantially deflated state to a substantially inflated state upon the bone reinforcing mixture entering the balloon when the balloon is in a cavity of the bone;

at least one light guide extending through the catheter into the balloon to guide a light into the balloon to illuminate and cure the bone reinforcing mixture contained in the balloon; and

a bone screw that is screwed into the balloon containing the cured bone reinforcing mixture.

24. The system of claim 23, wherein an outer surface of the balloon is preformed to be contained within the cavity of the fractured bone or the weakened bone.

25. The system of claim 23, further comprising an outer balloon surrounding the balloon.

26. The system of claim 23, wherein the bone from the group consisting of a radius, an ulna, a clavicle, a metacarpal, a phalanx, a metatarsal, a phalange, a tibia, a fibula, a humerus, a spine, a rib and a vertebra.

27. A system for delivering a bone reinforcing mixture to a fractured bone or a weakened bone comprising:

a catheter having a proximal end, a distal end, and a longitudinal axis therebetween, wherein the catheter has at least one inner lumen for passing a bone reinforcing mixture therethrough;

a balloon engaging the distal end of the catheter, wherein the balloon expands from a substantially deflated state to a substantially inflated state upon the bone reinforcing mixture entering the balloon when the balloon is in a cavity of the bone;

at least one light guide extending through the catheter into the balloon to guide a light into the balloon to illuminate and cure the bone reinforcing mixture contained in the balloon; and

a plate engaging the balloon containing the cured bone reinforcing mixture.

28. The system of claim 27, wherein the plate is screwed into the balloon containing the cured bone reinforcing mixture.

29. The system of claim 27, further comprising a screw that is screwed into the balloon to connect the plate to the balloon.

30. The system of claim 27, further comprising an outer balloon surrounding the balloon.

31. The system of claim 27, wherein an outer surface of the balloon is preformed to be contained within the cavity of the fractured bone or the weakened bone.

32. The system of claim 27, wherein the bone is from the group consisting of a radius, an ulna, a clavicle, a metacarpal, a phalanx, a metatarsal, a phalange, a tibia, a fibula, a humerus, a spine, a rib and a vertebra.

33. A method for reinforcing a bone comprising:

penetrating the bone to gain access to a cavity in the bone;

inserting a balloon into the cavity in the bone;

introducing a bone reinforcing mixture into the balloon through at least one lumen of a catheter connected to the balloon;

activating a light source connected to at least one light guide extending through the catheter into the balloon to illuminate and harden the bone reinforcing mixture contained in the balloon; and

screwing a device into the balloon containing the hardened reinforcing mixture.

34. The method of claim 33, wherein the device provides support for compression and torsion of the balloon.

35. The method of claim 33, wherein the device is a screw.

36. The method of claim 33, wherein the device is a plate.

37. The method of claim 33, wherein the device is a pin.

38. The method of claim 33, wherein the bone is from the group consisting of a radius, an ulna, a clavicle, a metacarpal, a phalanx, a metatarsal, a phalange, a tibia, a fibula, a humerus, a spine, a rib and a vertebra.