RESORBABLE HOLLOW DEVICES FOR IMPLANTATION AND DELIVERY OF THERAPEUTIC AGENTS

• US 20090259177A1
• Filed: 04/15/2009
• Published: 10/15/2009
• Est. Priority Date: 02/16/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Tai, Joseph, Vaccaro, Alexander R., Riley, Susan Lynn
• Granted Patent: US 9,662,152 B2
• Time in Patent Office: Days
• US Class Current: 604/96.10
• 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 resorbable balloon formed by heating a region of a tube 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 multi-polymers of the above listed polymers, 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;

sealing an end of the tube in proximity to the balloon so that the lumen is obstructed only at the sealed end; and

inserting a nonporous resorbable device through the lumen and into the balloon, the device being catheterless and expandable, and having two opposing ends and a hollow interior extending therebetween along the axis and coaxially with the lumen.

31. The resorbable balloon as set forth in claim 1, wherein the tube is made of polycarbonates selected from a group comprising polytrimethylene carbonate, tyrosine derived polycarbonates, poly(iminocarbonates), and combinations thereof.

32. The resorbable balloon as set forth in claim 1, wherein the tube is made of polyoxaesters selected from a group comprising poly(p-dioxanone).

2. A method, comprising:

providing a cavity;

inserting a deflated resorbable balloon into the cavity;

partially inflating an expandable portion of the resorbable balloon;

inserting a nonporous resorbable device through a lumen of the resorbable balloon and into the expandable portion, the device being catheterless and having two opposing ends and an unobstructed hollow interior therebetween that is positioned along a longitudinal axis of and coaxial with the lumen;

filling the expandable portion with a first agent, thereby causing it to expand and at least partially fill the cavity;

partially expanding the device; and

loading the device and expanding it with a therapeutic agent.

3. The method as set forth in claim 2, wherein the partial inflating of the expandable portion and the inserting are performed at the same time.

4. The method as set forth in claim 2, wherein the partial expanding, and the loading and expanding, of the device are performed at the same time.

5. The method as set forth in claim 2, wherein the interior of the device has a longitudinal device axis, and the loading and expanding of the device comprise:

inserting a container through and into the hollow interior of the device, the container having two opposing parts and a cavernous region extending therebetween that is positioned along the longitudinal device axis and coaxial with the hollow interior of the device;

filling the device with the therapeutic agent, thereby causing it to expand and at least partially fill the expandable portion; and

partially expanding the container with another therapeutic agent.

6. The method as set forth in claim 2, wherein the providing comprises providing a cavity within bone and the first agent comprises bone cement.

7. The method as set forth in claim 6, wherein the providing of a cavity comprises evacuating a volume of bone.

8. The method as set forth in claim 7, wherein a size of the cavity is increased by 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™

).

9. A method, comprising:

providing a first collapsible resorbable hollow device;

identifying a cavity in an anatomical location;

inserting the first collapsible resorbable hollow device into the cavity;

providing a nonporous collapsible resorbable hollow device; and

disposing the nonporous collapsible resorbable hollow device within the first collapsible resorbable hollow device, the two remaining without a catheter.

10. The method as set forth in claim 9, wherein the inserting is followed by injecting at least one therapeutic agent into the first collapsible resorbable hollow device.

11. The method as set forth in claim 10, 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

12. The method as set forth in claim 11, wherein the inserting is performed laparoscopically.

13. The method as set forth in claim 11, further comprising injecting at least one therapeutic agent into the nonporous collapsible resorbable hollow device.

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

providing one or more additional collapsible resorbable hollow devices;

nesting the additional collapsible resorbable hollow devices; and

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

15. The method as set forth in claim 14, 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.

16. The method as set forth in claim 15, 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.

17. The method as set forth in claim 15, 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.

18. The method as set forth in claim 15, wherein the injecting of a synthetic organic substance comprises injecting one or more of a drug, antibiotic, steroid, glycerol, polymer, and combinations thereof.

19. The method as set forth in claim 18, wherein the injecting of a polymer comprises injecting one or more of polyester, silicone, polyethylene oxide, polypropylene fumarate, pluronics, polyhydroxymethacrylate, polymethylmethacrylate, and combinations thereof.

20. The method as set forth in claim 15, wherein the injecting of an inorganic material comprises injecting one or more of calcium phosphate, allograft bone, ceramics, metals, and combinations thereof.

21. The method as set forth in claim 20, wherein the injecting of calcium phosphate comprises injecting at least one of beta-tricalcium phosphate and hydroxapatite.

22. The method as set forth in claim 14, 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.

23. The method as set forth in claim 9, 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.

24. The method as set forth in claim 9, 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.

25. The method as set forth in claim 10, 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.

26. The method as set forth in claim 25, further comprising closing the opening and then removing the conduit.

27. The method as set forth in claim 26, wherein the removing of the conduit forms an opening in the hollow device.

28. The method as set forth in claim 10, 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.

29. The method as set forth in claim 28, further comprising:

removing the conduit; and

closing the opening.

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