Balloon compressor for internal fixation of bone fractures

• US 5,658,310 A
• Filed: 06/05/1995
• Issued: 08/19/1997
• Est. Priority Date: 10/01/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Spine LLC (Medtronic Plc)
• Original Assignee: Berger J. Lee
• Inventors: Berger, J. Lee
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/464,294
• Time in Patent Office: 806 Days
• Field of Search: 606/60, 606/62, 606/191, 606/192, 606/194, 606/155, 606/92-95, 604/96, 128/DIG. 20
• US Class Current: 606/192
• CPC Class Codes: A61B 17/7225 for bone compression
• CPC Class Codes: A61B 17/7266 with fingers moving radially outwardly
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence

Abstract

The present invention is directed toward a method and apparatus for performing an internal fixation of fractures of tubular bones using a balloon catheter fixation device which is guided and transported through the medullary canal and fracture site of the bone by a plurality of guide wires mounted in said balloon catheter fixation device. A bone cement is applied to the fracture site and the balloon catheter is inflated inside the bone and tightened by applying pressure on the catheter outside of the bone by tightening the catheter tube and holding the same in place in an inflated condition to apply a compression force across the fracture site enhancing the stability of the fractured bone and promoting osseous healing.

Claims

1. An assembly for setting fractured bones comprising a balloon catheter with a tubing having an inner lumen and an inflatable balloon secured to said tubing at the distal end thereof, said balloon being in fluid communication with the lumen of said tubing, a guide wire mounted to said balloon and means separate from said balloon catheter adapted to be mounted in a portion of said fractured bone distal from said balloon to receive said tubing and hold said balloon catheter when said balloon is inflated in a fixed stressed condition to provide compression on the fracture side of fractured bone portions and a fluid discharge means connected to said balloon catheter and communicating with said tubing lumen to allow fluid discharge from said fluid discharge means into said tubing lumen to inflate the balloon of said balloon catheter.

2. The assembly of claim 1 including a pressure monitoring means connected to said balloon catheter and communicating with said tubing lumen to measure the pressure of the inflated balloon of said catheter.

3. The assembly of claim 1 wherein said catheter tubing is flexible and reinforced.

4. The assembly of claim 1 wherein said catheter tubing is elastic and constructed of teflon.

5. The assembly of claim 1 wherein said balloon has fluted sides.

6. The assembly of claim 1 wherein said fluid is a saline solution.

7. An assembly for setting fractured bones comprising a balloon catheter with a tubing having an inner lumen and an inflatable balloon secured to said tubing at the distal end thereof, said balloon being in fluid communication with the lumen said tubing, a guide wire mounted to said balloon and means separate from said balloon catheter adapted to be mounted in a portion of said fractured bone distal from said balloon to receive said tubing and hold said balloon catheter when said balloon is inflated in a fixed stressed condition to provide compression on the fracture side of fractured bone portions and a fluid discharge means connected to said balloon catheter and communicating with said tubing lumen to allow fluid discharge from said fluid discharge means into said tubing lumen to inflate the balloon of said balloon catheter, said means adapted to be mounted in a portion of said fractured bone is a hollow post member with external screw threads.

8. The assembly of claim 7 wherein said hollow post member adapted to be mounted in a portion of said fractured bone includes set screw means moveably mounted therein.

9. The assembly of claim 8 wherein said set screw means comprises a ball seat defined by said hollow post, a throughgoing channel formed in said hollow post member leading into said ball seat, a ball seated in said ball seat and a set screw moveably mounted in said throughgoing channel adapted to engage and move said ball.

10. An assembly for setting a fractured bone by holding the fractured bone portions together under a compression force across the fracture site comprising a balloon catheter with a tubing having an inner lumen and an inflatable balloon secured to said tubing and being in fluid communication with the lumen of said tubing, said balloon catheter being sized to move within the medullary cavity of the bone, a guide wire mounted to said balloon and mounting means adapted to be mounted in a portion of said fractured bone distal from said balloon, said mounting means selectively engaging said tubing and holding said tubing in a fixed stressed condition to provide compression on the fracture site of fractured bone portions after said balloon has been inflated inside one of said bone portions, and means connected to said tubing allowing the inflation of said balloon with fluid.

11. An assembly for setting a fractured bone by holding the fractured bone portions together under a compression force across the fracture site comprising a balloon catheter with a tubing having an inner lumen and an inflatable balloon secured to said tubing and being in fluid communication with the lumen of said tubing, said balloon catheter being sized to move within the medullary cavity of the bone, a guide wire mounted to said balloon and mounting means adapted to be mounted in a portion of said fractured bone distal from said balloon, said mounting means selectively engaging said tubing and holding said tubing in a fixed stressed condition to provide compression on the fracture site of fractured bone portions after said balloon has been inflated inside one of said bone portions, said mounting means comprises a post member with a throughgoing lumen and set screw means threadably mounted to said post member and extending into said lumen and means connected to said tubing allowing the inflation of said balloon with fluid.

12. The assembly of claim 11 wherein said set screw means comprises a ball seat defined by said post member communicating with said lumen, a throughgoing channel cut in said post member leading into said ball seat, a ball seated in said ball seat and extending into said lumen and a set screw moveably mounted in said throughgoing channel adapted to engage and move said ball into said lumen.

13. An assembly for setting a fractured bone by holding the fractured bone portions together under a compression force across the fracture site comprising an expandable catheter device with a tubing sized to move within the medullary cavity of the bone, a guide wire mounted to said expandable catheter device and mounting means adapted to be mounted in a portion of said fractured bone distal from said expandable catheter device, said mounting means selectively engaging said tubing and holding said tubing in a fixed stressed condition to provide compression on the fracture site of fractured bone portions after said expandable catheter device has been expanded inside one of said bone portions, and means connected to said tubing means allowing the expansion of said expandable catheter device.

14. The assembly of claim 13 wherein said mounting means comprises a post member with a throughgoing lumen and set screw means threadably mounted to said post member and extending into said lumen.

15. The assembly of claim 13 wherein said tubing is elastic.

16. A method of setting a fractured bone by compression comprising the steps of:

a) cutting an aperture into one portion of the fractured bone away from the site of the fracture allowing communication with the medullary canal of the bone;

b) securing a hollow fixation post means in said aperture;

c) inserting a balloon catheter device and catheter guide wire means through the fixation cut in the bone into the medullar cavity of the bone;

d) transporting the balloon catheter in the medullary canal of the bone past the fracture site by use of the catheter guide wire means to a point distal from the fractured site;

e) inflating the balloon of the balloon catheter device to its maximum diameter so that the balloon catheter device is held securely in place by the positive pressure of the balloon applied to the intramedullary walls of the bone;

f) applying bone cement material to at least one fracture site of the bone; and

g) tightening the attached catheter with the fixed balloon in place to align the fracture and compress the proximal and distal portions of the fractured bone together.

17. The method of claim 16 wherein said application step of applying bone cement material comprises injecting said bone cement material into said fracture site and allowing the bone cement material to harden.

18. The method of claim 16 wherein said tightening step uses a threaded fixation screw means as the securing device.

19. A method of setting a fractured bone by compression comprising the steps of:

a) cutting an aperture into one portion of the fractured bone away from the site of the fracture allowing communication with the medullary canal of the bone;

b) securing a hollow fixation post means in said aperture;

c) inserting a balloon catheter device and catheter guide wire means through the fixation cut in the bone into the medullar cavity of the bone;

d) transporting the balloon catheter in the medullary canal of the bone past the fracture site by use of the catheter guide wire means to a point distal from the fractured site;

e) inflating the balloon of the balloon catheter device to its maximum diameter so that the balloon catheter device is held securely in place by the positive pressure of the balloon applied to the intramedullary walls of the bone;

f) applying bone cement material to at least one fracture site of the bone; and

g) tightening the attached catheter with the fixed balloon in place to align the fracture and compress the proximal and distal portions of the fractured bone together, said tightening step using a threaded fixation screw means as the securing device, and said fixation screw means includes a ball and ball camming means to engage and secure the balloon catheter.

20. The method of claim 19 wherein said bone cement material is a bone-mineral substitute.

21. The method of claim 19 wherein said bone cement material is biodegradable.

22. A method of setting a fractured bone by compression comprising the steps of:

a) cutting an aperture into one portion of the fractured bone away from the site of the fracture allowing communication with the medullary canal of the bone;

b) securing a hollow fixation post means in said aperture;

c) inserting an expandable catheter device and catheter guide wire means through the fixation post means cut in the bone into the medullar cavity of the bone;

d) transporting the expandable catheter device in the medullary canal of the bone past the fracture site by use of the catheter guide wire means to a point distal from the fractured site;

e) expanding the expandable catheter device against the intramedullary walls of the bone so that pressure is uniformly exerted on the bone so that the catheter device is held securely in place by the positive pressure of the expanded device applied to the intramedullary walls of the bone;

f) applying bone cement material to at least one fracture site of the bone;

g) tightening the catheter device with the expanded catheter device secured in place to align the fracture and compress the proximal and distal portions of the fractured bone together; and

h) securing the catheter device in the tightened position.

23. The method of claim 22 wherein said application step of applying bone cement material comprises injecting said bone cement material into said fracture site and allowing the bone cement material to harden.