Resorbable hollow devices for implantation and delivery of therapeutic agents

• US 20060182780A1
• Filed: 02/16/2006
• Published: 08/17/2006
• Est. Priority Date: 02/16/2005
• Status: Abandoned Application

• Current Assignee: Alexander R. Vaccaro
• Original Assignee: Alexander R. Vaccaro
• Inventors: Vaccaro, Alexander R., Riley, Susan Lynn, Tai, Joseph
• Application Number:
  US11/357,837
• Publication Number:
  US 20060182780A1
• Time in Patent Office: Days
• US Class Current: 424/426
• 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 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/8813 Discharging means for excessively introduced fluid fillers, e.g. discharging excess cement
• CPC Class Codes: A61B 2017/883 Means for indicating hardening of bone cement
• 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 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• 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 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A method of manufacturing a resorbable balloon designed to contain bone cement for vertebroplasty or kyphoplasty applications is described. The resorbable balloon can be inserted into a vertebral body following vertebral cavitation and filled with bone cement. The balloon remains in place in the vertebral body and resorbs over time. Methods and apparatus are also described for delivering therapeutic agents using collapsible, resorbable balloons. The balloons may be nested and filled with various therapeutic agents that are released over time at rates dependent upon structures and degradation rates of the balloons. Furthermore, the function of the hollow devices can encompass both encapsulation and therapeutic substance delivery roles simultaneously.

Claims

1. A method of forming a resorbable balloon, comprising:

heating a region of a tube and pulling tubing along an axis of the tube, thereby thinning a wall of the tube at the heated region;

forcing a gas or liquid through a lumen of the tube while heating the region of the tube, thereby causing a portion of the tubing to expand and form a balloon; and

sealing an end of the tube in proximity to the balloon.

2. The method as set forth in claim 1, wherein the heating is preceded by:

extruding resorbable tubing; and

cutting tubing to desired lengths, thereby forming the plurality of tubes.

3. The method as set forth in claim 1, wherein one end of the tube is sealed before forcing a gas or liquid through the lumen of the tube.

4. The method as set forth in claim 3, wherein the sealing of an end of the tube comprises gluing a resorbable plug into the lumen.

5. The method as set forth in claim 3, wherein the sealing of an end of the tube comprises at least one of thermally welding or heat sealing the tube.

6. The method as set forth in claim 1, wherein the sealing is followed by removing excess tubing beyond the sealed point.

7. The method as set forth in claim 1, wherein the liquid or gas is heated air.

8. A resorbable balloon formed by the method of claim 1 that is made of a resorbable polymer, including one or more of poly-L-lactide, poly-DL-lactide, polyglycolide, polycaprolactone, polytrimethylene carbonate, polydioxanone, polydioxane, and copolymers or mulit-polymers of the above listed polymers.

9. A method of performing bone restoration, comprising:

providing a cavity within the bone;

inserting a deflated resorbable balloon into the cavity; and

filling the resorbable balloon with bone cement, thereby causing the resorbable balloon to expand and fill the cavity.

10. The method as set forth in claim 9, wherein the providing of a cavity comprises evacuating a volume of bone.

11. The method as set forth in claim 10, wherein increasing the size of the cavity comprises inserting a deflated non-resorbable balloon into the cavity and filling the balloon with a liquid or gas to expand the balloon and increase the size of the bone cavity (e.g. kyphoplasty™

).

12. A method of providing therapy, comprising:

providing a first collapsible resorbable hollow device;

identifying a cavity in an anatomical location; and

inserting the first collapsible resorbable hollow device into the cavity.

13. The method as set forth in claim 12, wherein the inserting is followed by injecting at least one therapeutic agent into the first collapsible resorbable hollow device.

14. The method as set forth in claim 13, wherein:

the identifying of a cavity in an anatomical location comprises forming a cavity in a desired anatomical location; and

the inserting is preceded by deflating the hollow device; and

15. The method as set forth in claim 14, wherein the inserting is performed laparoscopically.

16. The method as set forth in claim 14, further comprising:

providing a second collapsible resorbable hollow device;

inserting the second collapsible resorbable hollow device into the first collapsible resorbable hollow device; and

injecting at least one therapeutic agent into the second collapsible resorbable hollow device.

17. The method as set forth in claim 16, further comprising:

providing one or more collapsible resorbable hollow devices;

nesting the collapsible resorbable hollow devices; and

injecting at least one therapeutic agent into each of the collapsible resorbable hollow devices.

18. The method as set forth in claim 17, wherein the injecting of at least one therapeutic agent comprises injecting one or more of a natural organic substance, a synthetic organic substance, an inorganic material, and combinations thereof.

19. The method as set forth in claim 18, wherein the injecting of a natural organic substance comprises injecting one or more of a living biological agent, proteins, a natural polymer, and combinations thereof.

20. The method as set forth in claim 18, wherein the injecting of a natural polymer comprises injecting one or more of a collagen, gelatin, fibrin, hyaluronic acid, polysaccharides, elastin, cellulose, polynucleotides, and combinations thereof.

21. The method as set forth in claim 18, wherein the injecting of a synthetic organic substance comprises injecting one or more of a drug, antibiotic, steroid, glycerol, polymer, and combinations thereof.

22. The method as set forth in claim 21, wherein the injecting of a polymer comprises injecting one or more of polyester, silicone, polyethylene oxide, polypropylene fumarate, pluronics, polyhydroxymethacrylate, polymethylmethacrylate, and combinations thereof.

23. The method as set forth in claim 18, wherein the injecting of an inorganic material comprises injecting one or more of calcium phosphate, allograft bone, ceramics, metals, and combinations thereof.

24. The method as set forth in claim 23, wherein the injecting of calcium phosphate comprises injecting at least one of beta-tricalcium phosphate and hydroxapatite.

25. The method as set forth in claim 17, wherein the providing of one or more collapsible resorbable hollow devices comprises providing a hollow device having perforations, whereby the therapeutic agent is delivered at a predetermined delivery rate.

26. The method as set forth in claim 12, wherein the providing of a first collapsible resorbable hollow device comprises providing a hollow device fabricated with a material containing an additive that accelerates resorption of the first collapsible resorbable hollow device.

27. The method as set forth in claim 12, wherein the providing of a first collapsible resorbable hollow device comprises providing a hollow device fabricated with a material containing an additive that retards resorption of the first collapsible resorbable hollow device.

28. The method as set forth in claim 13, further comprising attaching a conduit to an opening of the first collapsible resorbable hollow device, the conduit acting to facilitate at least one of loading of the first collapsible resorbable hollow device with the at least one therapeutic agent and aiding in positional manipulation of the hollow device.

29. The method as set forth in claim 28, further comprising closing the opening and then removing the conduit.

30. The method as set forth in claim 29, wherein the removing of the conduit forms an opening in the hollow device.

31. The method as set forth in claim 13, wherein a conduit to an opening of the first collapsible resorbable hollow device is formed as a continuous part of the device, the conduit acting to facilitate loading of the first collapsible resorbable hollow device with the at least one therapeutic agent.

32. The method as set forth in claim 31, further comprising:

removing the conduit; and

closing the opening.

33. The method as set forth in claim 32, wherein the removing of the conduit forms an opening in the hollow device.

34. A collapsible, resorbable balloon formed of one or more of aliphatic polyesters, polycarbonates, polyoxaesters, polyorthoesters, polyanhydrides, polyphosphoesters, polyphosphazenes, polypropylene fumarates, polyamino acids, other polyamides, pseudopoly(amino acids), polyamidoesters, polyarylates, polyoxaesters containing amine groups, polyalkylene oxalate, polyhydroxybuyrate, polyhydroxyvalerate, resorbable polyurethanes, resorbable starches, resorbable silk, and combinations (co- or multi-polymers or blend) of any of the above with nonresorbable polymers, and any combination thereof.

35. The collapsible, resorbable balloon as set forth in claim 34, wherein the aliphatic polyesters are selected from a group comprising one or more of polyL-lactide, polyD-lactide, polyglycolide, poly ε

-caprolactone, and combinations thereof.

36. The collapsible, resorbable balloon as set forth in claim 34, wherein the polycarbonates are selected from a group comprising polytrimethylene carbonate, tyrosine derived polycarbonates, poly(iminocarbonates), and combinations thereof.

37. The collapsible, resorbable balloon as set forth in claim 34, wherein the polyoxaesters are selected from a group comprising poly(p-dioxanone).