Apparatus for Delivery of Reinforcing Materials to Bone

• US 20140148813A1
• Filed: 02/03/2014
• Published: 05/29/2014
• Est. Priority Date: 04/26/2006
• Status: Active Grant

• Current Assignee: Illuminoss Medical, Inc.
• Original Assignee: Illuminoss Medical, Inc.
• Inventors: Rabiner, Robert A.
• Granted Patent: US 9,254,156 B2
• Time in Patent Office: Days
• US Class Current: 606/93
• 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 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 radial structural member engaging the balloon;

a bone reinforcing mixture contained in the balloon, 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 catheter into the balloon to guide a light into the balloon to cure the bone reinforcing mixture.

2. The system of claim 1, wherein the radial structural member engages the balloon on an outer surface of the balloon.

3. The system of claim 1, wherein the balloon and the radial structural member expand when the bone reinforcing mixture enters into the balloon.

4. The system of claim 1, wherein the radial structural member extends beyond a distal end of the balloon.

5. The system of claim 1, wherein the radial structural member extends beyond a distal end and a proximal end of the balloon.

6. The system of claim 1, wherein the radial structural member is an expandable mesh.

7. The system of claim 1, wherein the radial structural member is a wire coil.

8. The system of claim 1, wherein the radial structural member is a slotted tube.

9. The system of claim 1, wherein the radial structural member includes a zigzag design.

10. The system of claim 1, wherein the radial structural member is a stent.

11. The system of claim 10, wherein the stent comprises a plurality of vanes that open perpendicular to an outer diameter of the stent when the stent is expanded.

12. The system of claim 11, wherein the plurality of vanes lie flat along an outer surface of the balloon when the stent is in a compressed state.

13. The system of claim 1, wherein the radial structural member is expandable within the balloon.

14. The system of claim 1, wherein the radial structural member engages the balloon on an inner surface of the balloon.

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

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

17. The system of claim 16, wherein the separation area is an illumination band configured to illuminate and cure the bone reinforcing material located in the catheter within the illumination band.

18. The system of claim 1, wherein the bone is a radius, ulna, clavicle, metacarpal, phalanx, metatarsal, phalange, tibia, fibula, humerus, spine, rib, or vertebra.

19. A system for delivering a bone reinforcing mixture to a fractured 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;

an expandable tube surrounding the balloon;

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

at least one light guide extending through the catheter into the balloon to guide a light into the balloon to harden the bone reinforcing mixture.

20. The system of claim 19, wherein the expandable tube surrounds a portion of the balloon.

21. The system of claim 19, wherein the expandable tube encapsulates the balloon.

22. The system of claim 19, wherein the tube includes a metal.

23. The system of claim 19, wherein the tube extends beyond an area of a fracture when in the cavity of the bone.

24. The system of claim 19, wherein the tube comprises pre-formed sections.

25. The system of claim 19, wherein the tube comprises four or more pre-formed sections.

26. The system of claim 19, wherein an outer surface of the tube includes ridges or serrations.

27. The system of claim 19, wherein the tube extends beyond a distal end of the balloon.

28. The system of claim 19, wherein the tube extends beyond a distal end and a proximal end of the balloon.

29. The system of claim 19, wherein the bone is a radius, ulna, clavicle, metacarpal, phalanx, metatarsal, phalange, tibia, fibula, humerus, spine, rib, or vertebra.

30. A system for delivering a bone reinforcing mixture to a fractured 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 radial structural member engaging the balloon, the radial structural member comprising a plurality of plates;

a bone reinforcing mixture contained in the balloon, 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; and

at least one light guide extending through the catheter into the balloon to guide a light into the balloon to cure the bone reinforcing mixture.

31. The system of claim 30, wherein at least one plate is connected to at least one wire.

32. The system of claim 31, wherein the at least one wire engaging adjacent plates.

33. The system of claim 32, further comprising at least one hinge engaging the at least one wire attached to the plates.

34. The system of claim 30, wherein the plurality of plates lie along the circumference and an outer surface of the balloon prior to inflation of the balloon.

35. The system of claim 30, wherein the plates are adjacent to and abut each other.

36. The system of claim 30, wherein the plates overlap each other.

37. The system of claim 36, wherein the overlapping plates form a rigid structure.

38. The system of claim 30, wherein the radial structural member expands as the balloon expands such that the plurality of plates move outward and away from each other.

39. The system of claim 30, wherein the bone is a radius, ulna, clavicle, metacarpal, phalanx, metatarsal, phalange, tibia, fibula, humerus, spine, rib, or vertebra.

40. A system for delivering a bone reinforcing mixture to a fractured 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;

an internal support structure engaging the balloon;

a bone reinforcing mixture contained in the balloon, 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; and

at least one light guide extending through the catheter into the balloon to guide a light into the balloon to cure the bone reinforcing mixture.

41. The system of claim 40, wherein the internal support structure engages an inner surface of the balloon.

42. The system of claim 40, wherein the internal support structure comprises stiff fibers.

43. The system of claim 40, wherein the internal support structure comprises an interlinked concentric ring of high modulus fiber.

44. The system of claim 40, wherein the internal support structure comprises interconnected strut connectors engaging circumferential supports.

45. The system of claim 40, wherein the bone is a radius, ulna, clavicle, metacarpal, phalanx, metatarsal, phalange, tibia, fibula, humerus, spine, rib, or vertebra.