Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bone

• US 20030229372A1
• Filed: 06/10/2003
• Published: 12/11/2003
• Est. Priority Date: 01/26/1994
• Status: Abandoned Application

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated
• Inventors: Scholten, Arie, Reiley, Mark A., Talmadge, Karen
• Application Number:
  US10/458,235
• Publication Number:
  US 20030229372A1
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• 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 2017/0256 for the spine
• CPC Class Codes: A61F 2/3601 for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices non-prosthetic internal fixation devices for the femoral head or neck A61B17/74
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2002/2828 Femoral head
• CPC Class Codes: A61F 2002/2832 Femoral neck
• CPC Class Codes: A61F 2002/2853 Humerus
• CPC Class Codes: A61F 2002/2871 Radius
• CPC Class Codes: A61F 2002/2892 Tibia
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/302 toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30228 Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30686 : Devices for removing particulate debris from prosthetic joints
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 : Necks
• CPC Class Codes: A61F 2002/4062 : Proximal or metaphyseal parts of shafts
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61M 2025/1072 : having balloons with two or more compartments
• CPC Class Codes: A61M 2210/02 : Bones
• CPC Class Codes: A61M 2210/1003 : Spinal column
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

A balloon for use in compressing cancellous bone and marrow (also known as medullary bone or trabecular bone) against the inner cortex of bones whether the bones are fractured or not. The balloon comprises an inflatable, non-expandable balloon body for insertion into said bone. The body has a shape and size to compress at least a portion of the cancellous bone to form a cavity in the cancellous bone and to restore the original position of the outer cortical bone, if fractured or collapsed. The balloon is prevented from applying excessive pressure to the outer cortical bone. The wall or walls of the balloon are such that proper inflation the balloon body is achieved to provide for optimum compression of all the bone marrow. The balloon is able to be folded so that it can be inserted quickly into a bone. The balloon can be made to have a suction catheter. It can also be coated with therapeutic substances. The main purpose of the balloon is the forming or enlarging of a cavity or passage in a bone, especially in, but not limited to, vertebral bodies. Another important purpose is to deliver therapeutic substances to bone in an improved way.

Claims

1. An assembly for delivering a therapeutic substance to a treatment site within bone, the assembly comprising

a cannula,

a catheter,

a balloon carried by the catheter and insertable into bone by means of passing the catheter through the cannula, said balloon comprising a wall having an outer surface and being capable of inflation from a collapsed configuration and being sized in the collapsed configuration for passage along with the catheter through the cannula for insertion into bone, to an expanded configuration which has a predetermined shape and size sufficient for compressing at least a portion of inner cancellous bone and which is restrained while being expanded in the presence of the cancellous bone, and

a therapeutic substance carried on the outer surface of the balloon wall to be incorporated into the cancellous bone by inflation of the balloon.

2. The assembly of claim 1, further comprising

an applicator for applying the therapeutic substance to the outer surface of the balloon wall.

3. The assembly of claim 2 wherein the applicator comprises a container having a reservoir of the therapeutic substance and a nozzle for dispensing the therapeutic substance onto the outer surface of the balloon wall.

4. The assembly of claim 3 wherein the therapeutic substance is a gel formulation.

5. The assembly of claim 2 wherein the applicator comprises a dry powder dispenser.

6. The assembly of claim 2, wherein the applicator comprises a dispersion device for spraying the therapeutic substance onto the outer surface of the balloon wall.

7. The assembly of claim 6 wherein the therapeutic substance is a powdered medicament.

8. The assembly of claim 1 wherein the therapeutic substance comprises a bone filling material.

9. The assembly of claim 1 wherein the therapeutic substance comprises a bone growth factor.

10. The assembly of claim 1 wherein the therapeutic substance comprises an antibiotic.

11. The assembly of claim 1 wherein the therapeutic substance comprises a gelatin powder.

12. The assembly of claim 11 wherein the therapeutic substance comprises an agent that absorbs body fluid.

13. The assembly of claim 11 wherein the therapeutic substance comprises an agent that inhibits flow of body fluid.

14. The assembly of claim 11 wherein the therapeutic substance comprises a hemostatic agent.

15. The assembly of claim 11 wherein the therapeutic substance is Gelfoam.

16. An assembly as in claim 1 wherein expansion of the balloon in cancellous bone is restrained by selected thickened wall portions of the balloon wall.

17. An assembly as in claim 1 wherein expansion of the balloon in cancellous bone is restrained by an internal restraint formed in the balloon wall.

18. An assembly as in claim 17 wherein the internal restraint comprises a seam in the balloon.

19. An assembly as in claim 17 wherein the internal restraint comprises a meshwork.

20. An assembly as in claim 17 wherein the internal restraint comprises a woven material.

21. An assembly as in claim 17 wherein the internal restraint comprises string.

22. An assembly as in claim 1 wherein expansion of the balloon in cancellous bone is restrained by an external restraint formed in the balloon wall.

23. An assembly as in claim 22 wherein the external restraint comprises a seam in the balloon.

24. An assembly as in claim 22 wherein the external restraint comprises a meshwork.

25. An assembly as in claim 22 wherein the external restraint comprises a woven material.

26. An assembly as in claim 22 wherein the external restraint comprises string.

27. An assembly as in claim 1 wherein the predetermined shape and size of the balloon when in the expanded configuration comprises opposed sides which are restrained to remain essentially flat.

28. An assembly as in claim 1 wherein the cannula is a percutaneous cannula.