Apparatus and methods for delivery of reinforcing materials to bone

• US 7,806,900 B2
• Filed: 04/26/2007
• Issued: 10/05/2010
• 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:
  US11/789,907
• Publication Number:
  US 20080039854A1
• Time in Patent Office: 1,258 Days
• Field of Search: 606/92, 606/93, 606/94, 606 62- 68, 604/21, 600/101, 600/116, 600/178, 623/23.62, 623/23.48, 623/23.58
• US Class Current: 606/92
• 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. An apparatus for delivering a reinforcing mixture to a long bone comprising:

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

a balloon engaging the distal end of 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 to illuminate and cure the bone reinforcing mixture,

wherein the balloon, when in the inflated state by the bone reinforcing mixture in a cavity of a fractured long bone, aligns bone fragments of the fractured long bone.

2. The apparatus of claim 1 further comprising a light source that provides light to the tube.

3. The apparatus of claim 2 wherein the light source provides an ultraviolet light to the tube.

4. The apparatus of claim 2 wherein the light source provides a visible light to the tube.

5. The apparatus of claim 1 further comprising an optical taper adjacent to the proximal end of the tube to guide light into the tube.

6. The apparatus of claim 1 further comprising a separation area on the distal end of the tube to separate the tube from the balloon.

7. The apparatus of claim 1 further comprising a radiopaque marker on a distal end of the balloon.

8. The apparatus of claim 1 further comprising an outer balloon surrounding the balloon.

9. The apparatus of claim 1 wherein at least a portion of the bone reinforcing mixture is removed from the balloon before curing.

10. The apparatus of claim 1 wherein the balloon inflates as the bone reinforcing mixture enters the balloon under pressure.

11. The apparatus of claim 1 wherein a surface of the balloon is substantially smooth.

12. The apparatus of claim 1 wherein a surface of the balloon is preformed to be contained within the cavity of the long bone.

13. The apparatus of claim 1 wherein the balloon is shaped to substantially conform to a wall of the cavity of the long bone.

14. An apparatus for delivering a reinforcing mixture to a long 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 reinforcing mixture therethrough;

a balloon extending from the distal end of the catheter, wherein the balloon begins to expand from a substantially deflated state to a substantially inflated state as the reinforcing mixture enters the balloon;

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

a junction connecting the catheter to the balloon, wherein the junction concentrates stress applied to the catheter at the junction,

wherein the balloon, when in the inflated state by the reinforcing mixture in a cavity of a fractured long bone, aligns bone fragments of the fractured long bone.

15. The apparatus of claim 14 wherein the junction includes at least one of a notch, a groove and a channel in the catheter.

16. The apparatus of claim 14 wherein the junction includes a pre-weakened area extending substantially around a circumference of the catheter.

17. The apparatus of claim 14 wherein the junction is designed to separate the balloon from the catheter under at least a predetermined load.

18. The apparatus of claim 14 wherein the junction extends less than an inch along the longitudinal axis of the catheter.

19. The apparatus of claim 14 further comprising a light source that provides light to the light guide.

20. The apparatus of claim 19 wherein the light source provides an ultraviolet light.

21. The apparatus of claim 19 further comprising at least one lumen of the catheter for transmitting light from the light source into the balloon.

22. The apparatus of claim 14 further comprising an illumination band located at the junction.

23. A method for reinforcing a long bone comprising:

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

inserting a balloon connected to a distal end of a catheter into the cavity in the long bone;

infusing a reinforcing mixture into the balloon through at least one lumen of the catheter; and

activating a light source to harden the reinforcing mixture in the balloon.

24. The method of claim 23 further comprising maintaining the balloon entirely within the cavity in the long bone.

25. The method of claim 23 further comprising separating the catheter from the balloon.

26. The method of claim 23 further comprising leaving the balloon in the cavity of the long bone.

27. The method of claim 23 wherein the light source provides an ultraviolet light.

28. The method of claim 23 further comprising inflating the balloon with the reinforcing mixture.

29. The method of claim 23 further comprising deflating the balloon by removing at least a portion of the reinforcing mixture before curing.

30. The method of claim 23 further comprising positioning the balloon with a first portion of the balloon on a first side of a fracture in the long bone and a second portion of the balloon on a second side of the fracture in the long bone.

31. The method of claim 23 further comprising transmitting light from the light source into the balloon through at least one second lumen of the catheter.

32. The method of claim 31 wherein the at least one lumen of the catheter and the at least one second lumen of the catheter are different lumens of the catheter.

33. The method of claim 23 further comprising infusing a second portion of the reinforcing mixture into the balloon catheter through the at least one lumen of the catheter and activating the light source to harden the second portion of the reinforcing mixture in the balloon.

34. A method for reinforcing a long bone comprising:

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

inserting a balloon into the cavity in the long 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 harden the bone reinforcing mixture in the balloon; and

separating the catheter from the balloon at a predetermined site.

35. The method of claim 34 further comprising forming the predetermined site before inserting the balloon into the cavity in the long bone.

36. The method of claim 35 wherein the predetermined site is formed by creating at least one of a notch, a groove and a channel in the catheter.

37. The method of claim 35 wherein the predetermined site is formed by weakening an area of the catheter.

38. The method of claim 34 further comprising twisting the catheter to separate the catheter from the balloon at the predetermined site.

39. The method of claim 34 further comprising transmitting light from a light source into the balloon through at least one second lumen of the catheter.

40. The method of claim 39 wherein light is transmitted into the balloon through a different lumen of the catheter than the at least one lumen of the catheter through which the bone reinforcing mixture is introduced.