Apparatus and methods for reinforcing bone

• US 8,348,956 B2
• Filed: 09/20/2010
• Issued: 01/08/2013
• 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): Robert, Eduardo C
• Assistant Examiner(s): COMSTOCK, DAVID C
• Application Number:
  US12/886,288
• Publication Number:
  US 20110009871A1
• Time in Patent Office: 841 Days
• Field of Search: 606 92- 95, 606/108, 606/192, 606 65- 67, 623/23.14, 623/23.19, 623/23.2, 623/23.48, 623/23.62
• US Class Current: 606/94
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• 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 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 17/8836 for heating, cooling or curing of bone cement or fluid fillers
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61L 2430/02 for reconstruction of bones; weight-bearing implants
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque

Abstract

Apparatuses and methods for reinforcing weakened or fractured bone are disclosed. An apparatus for delivering a bone reinforcing mixture to a bone includes 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 through, and a bone fitting portion having an opening for accepting the tube, an insertion portion for insertion into the bone, and at least one relief valve.

Claims

1. An apparatus for delivering a bone reinforcing mixture to a 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 capable of allowing a bone reinforcing mixture to pass through; and

a bone fitting portion having an opening for extending the tube through, a screw-thread portion for screwing through layers of the bone, a stopper that limits the insertion of the bone fitting portion into the bone, a grip portion for assisting in inserting the bone fitting portion into the bone, and at least one valve for relieving a pressure buildup in the bone void during delivery of the bone reinforcing mixture,

wherein the screw-thread portion extends into a bone void of the bone, and

wherein the tube extends through the bone fitting portion and into the bone.

2. The apparatus of claim 1 wherein the tube moves within the bone to reach different locations.

3. The apparatus of claim 1 wherein the bone reinforcing mixture has a viscosity of less than about 1000 cP.

4. The apparatus of claim 1 further comprising an adhesive system releasably attached at the proximal end of the tube for delivering the bone reinforcing mixture.

5. The apparatus of claim 4 wherein the adhesive system delivers a drug.

6. The apparatus of claim 1 wherein the screw-thread portion extends through an outer surface of the bone, through an inner surface of the bone, and into the bone void of the bone.

7. The apparatus of claim 1 wherein the distal end of the tube includes at least one fenestration.

8. A system for reinforcing a 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 allowing a bone reinforcing mixture to pass therethrough and a second inner lumen;

a bone fitting portion having an opening for extending the tube through and a screw-thread portion for screwing through layers of the bone;

an adhesive system engaging the proximal end of the tube for housing the bone reinforcing mixture; and

a light source to provide light passing through the second inner lumen to harden the bone reinforcing mixture.

9. The system of claim 8 wherein the tube moves within a bone void of the bone to reach different locations within the bone void.

10. The system of claim 8 wherein the bone reinforcing mixture has a viscosity of less than about 1000 cP.

11. The system of claim 8 wherein the distal end of the tube includes a balloon portion capable of inflating and deflating.

12. The system of claim 8 wherein the bone fitting portion further comprises:

a stopper that limits the insertion of the bone fitting portion into the bone,

a grip portion for assisting in inserting the bone fitting portion into the bone, and

at least one valve for relieving a pressure buildup in a bone void of the bone during delivery of the bone reinforcing mixture.

13. The system of claim 8 wherein the screw-thread portion extends through an outer surface of the bone, through an inner surface of the bone, and into a bone void of the bone, and wherein the tube extends through the bone fitting portion and into the bone.

14. The system of claim 8 wherein the adhesive system delivers a drug.

15. The system of claim 8 wherein the distal end of the tube includes at least one fenestration.

16. A method for reinforcing a bone comprising:

penetrating the bone at a site adjacent to a weakened or fractured area of the bone to gain access to an interior of the bone;

forming a bone void in the interior of the bone having a distal edge and a proximal edge;

inserting a bone fitting portion at the penetration site, the bone fitting portion having an opening, a screw-thread portion for screwing through layers of the bone, and at least one relief valve;

positioning a catheter having a proximal end, a distal end, and a longitudinal axis therebetween through the opening of the bone fitting portion so the distal end of the catheter is within the bone void;

infusing a bone reinforcing mixture through at least one inner lumen of the catheter into the bone void; and

removing the catheter from the bone fitting portion.

17. The method of claim 16 further comprising removing medullary material located in a medullary cavity of the bone to form the bone void.

18. The method of claim 16 further comprising moving the catheter towards the proximal edge of the bone void and infusing the bone reinforcing mixture through the catheter.

19. The method of claim 16 further comprising moving the catheter towards the distal edge of the bone void and infusing the bone reinforcing mixture through the catheter.

20. The method of claim 16 further comprising adding the bone reinforcing mixture until the bone reinforcing mixture has filled the bone void.

21. The method of claim 16 further comprising inserting reinforcing materials into the bone void before positioning the catheter through the opening, the reinforcing materials providing structure and support for the bone reinforcing mixture.

22. The method of claim 16 further comprising allowing the bone reinforcing mixture to harden and removing the bone fitting portion from the bone.

23. The method of claim 16 further comprising inserting an optical rod into a central space of the bone void and illuminating the rod to harden any remaining bone reinforcing mixture.

24. The method of claim 16 further comprising applying pressure to ensure that the bone reinforcing mixture fills the bone void.