METHODS AND DEVICES FOR TREATING FRACTURED AND/OR DISEASED BONE

• US 20020161373A1
• Filed: 04/05/2001
• Published: 10/31/2002
• Est. Priority Date: 08/14/1998
• Status: Active Grant

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Layne, Richard W., Talmadge, Karen D., Follmer, Marialulu, Boucher, Ryan P., Basista, Joseph J., Osorio, Reynaldo A.
• Granted Patent: US 6,726,691 B2
• Time in Patent Office: Days
• US Class Current: 606/86
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• 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 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2017/00464 for use with different instruments with hole for different instruments A61B2017/22072
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

Abstract of Disclosure

The present invention relates to devices and methods for treating fractured and/or diseased bone. More specifically, the present invention relates to devices and methods for repairing, reinforcing and/or treating fractured and/or diseased bone using various devices, including cavity-forming devices.

Claims

1. A method for treating or preventing a vertebral compression fracture comprising the steps of:

inserting an insertion device percutaneously into a vertebral body;

inserting a cavity-forming device through the insertion device into an area of cancellous bone in the vertebral body;

displacing cancellous bone with the cavity-forming device to create a cavity and a barrier region of compressed cancellous bone substantially surrounding the cavity; and

filling at least a portion of the cavity with a bone filler.

2. The method of claim 1 further wherein, after the filling step, inserting a cavity-forming device into the cavity and compressing at least a portion of the bone filler against the barrier region.

3. The method of claim 1 wherein the needle assembly comprises a needle.

4. The method of claim 3 wherein the needle assembly comprises an eleven-gauge needle.

5. The method of claim 1 wherein the cavitation device is selected from the group consisting of a mechanical tamp, a reamer, a drill, a hole puncher and a balloon catheter.

6. The method of claim 1 wherein the cavitation device is a balloon catheter comprising:

a tube comprising a distal end and a proximal end;

an expandable structure; and

a fitting comprising at least one port;

7. The method of claim 6 wherein the tube of the balloon catheter is hollow and comprises at least one opening near the distal end of the tube.

8. The method of claim 7 wherein the expandable structure of the catheter is bonded to the distal end of the tube.

9. The method of claim 8 wherein the expandable structure is inflated with an inflation medium, thereby forming a cavity and a barrier surrounding the cavity within the vertebral body;

and wherein the expandable structure is subsequently deflated and removed through the insertion device.

10. The method of claim 9 wherein the inflation medium is selected from the group consisting of air, nitrogen, saline, water and combinations thereof.

11. The method of claim 1 wherein the bone filler is a polymethylmethacrylate.

12. A method for treating or preventing a vertebral compression fracture comprising the steps of:

inserting a spinal needle of a needle assembly percutaneously through a pedicle into a vertebral body;

inserting a balloon catheter through the spinal needle into an area of cancellous bone within the vertebral body, so that the distal end of the balloon catheter extends out of the distal end of the spinal needle;

inflating the balloon catheter with an inflation medium such that inflation of the distal end of the balloon catheter extending from the spinal needle displaces cancellous bone around the inflating balloon, forming a barrier around the balloon catheter that at least partly closes large cracks or veins within the cancellous bone area of the vertebral body;

deflating the balloon catheter and leaving a cavity within the cancellous bone area of the vertebral body;

removing the balloon catheter from the vertebral body through the needle assembly; and

filling the cavity with a bone filler.

13. The method of claim 12 wherein the inflation medium comprises sterile saline.

14. The method of claim 13 wherein the bone filler is polymethylmethacrylate.

15. A balloon catheter comprising:

a tube comprising a distal end and a proximal end;

a lumen within the tube;

an expandable material;

an opening formed in the tube, the opening communication with the lumen;

wherein

at least a portion of the expandable material is located within the lumen.

16. The balloon catheter of claim 15 further comprising at least one opening in a wall of the tube near a distal end of the tube.

17. The balloon catheter of claim 16 wherein an inflation medium may be pumped into the expandable material, out of the expandable material, or both into and out of the expandable material, through the at least one opening near the distal end of the tube.

18. The balloon catheter of claim 15 wherein the expandable material is polyurethane.

19. The balloon catheter of claim 15 wherein the fitting is a Leur T-Fitting comprising two ports.