Bulking agent

• US 8,394,400 B2
• Filed: 11/16/2010
• Issued: 03/12/2013
• Est. Priority Date: 06/12/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Bourne, George, Madden, Mike, Madenjian, Art, Rao, Doreen, Buiser, Marcia, Li, Jianmin, Rackley, Raymond, Gellman, Barry N.
• Primary Examiner(s): BARHAM, BETHANY P
• Application Number:
  US12/946,990
• Publication Number:
  US 20110064774A1
• Time in Patent Office: 847 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 25/1025 Connections between catheter tubes and inflation tubes
• CPC Class Codes: A61M 5/31 Details
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

The invention relates to bulking agents and apparatus and methods for using the disclosed bulking agents. The bulking agents can be used to treat such conditions as urinary and fecal incontinence, gastro-esophageal reflux, aneurismal blockages, and cosmetic deformities. The invention also relates to an injection method that reduces the injection pressure required to place the bulking agents.

Claims

1. An apparatus for bulking mammalian tissue comprising:

a needle defining a lumen, the needle adapted to penetrate the mammalian tissue;

an inflation device adapted to advance through the lumen of the needle and disposable adjacent to the mammalian tissue, wherein the inflation device comprises an adaptor for locking the inflation device to the needle, and wherein the inflation device is inflatable and subsequently deflatable to create a void in the mammalian tissue; and

a bulking agent insertable via the lumen of the needle to at least partially fill the void in the tissue.

2. The apparatus of claim 1 wherein the inflation device comprises a biocompatible balloon.

3. The apparatus of claim 1 wherein the inflation device comprises a color coating for visualization.

4. The apparatus of claim 1 wherein the inflation device comprises at least one of a silicone, an ethylene vinyl alcohol, a polypropylene, a latex rubber, a polyurethane, a polyester, a nylon, and a thermoplastic rubber.

5. The apparatus of claim 1 wherein the inflation device comprises a shape selected from the group consisting of substantially round, oval, hemi spherical, spherical, and oblong.

6. The apparatus of claim 1 wherein the bulking agent comprises a plurality of polymeric particles.

7. The apparatus of claim 1 wherein the bulking agent is injected into the void by a syringe.

8. The apparatus of claim 1 wherein the bulking agent comprises:

a carrier, and a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier, the carrier aiding delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked.

9. The apparatus of claim 1 wherein the bulking agent comprises a color.

10. The apparatus of claim 9 wherein the needle is sized from 16 gauge to 24 gauge.

11. A method for bulking mammalian tissue using the apparatus of claim 1, comprising:

inserting the needle within a portion of a mammal;

advancing the inflation device through a lumen of the needle;

inflating the inflation device to compress the mammalian tissue surrounding the inflated inflation device, thereby creating a void in the tissue;

deflating the inflation device;

removing the inflation device from the needle; and

injecting the bulking agent through the needle to fill at least partially the void.

12. The method of claim 11 further comprising:

inserting a penetration device along with the needle into the mammalian tissue;

removing the penetration device while retaining the inserted needle; and

advancing the inflation device through the needle.

13. The method of claim 11 wherein the inflation device comprises a color for visualization.

14. The method of claim 11 wherein the inflation device comprises at least one of a silicone, an ethylene vinyl alcohol, a polypropylene, a latex rubber, a polyurethane, a polyester, a nylon, and a thermoplastic rubber.

15. The method of claim 11 wherein the inflation device comprises a shape selected from the group consisting of substantially round, oval, hemi spherical, spherical, and oblong.

16. The method of claim 11 wherein the bulking agent comprises:

a carrier, and a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier, the carrier aiding delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked.

17. The apparatus of claim 1, wherein the inflation device and needle comprise interlocking luer hubs.

18. The apparatus of claim 2, wherein the balloon extends beyond the tip of the needle when the inflation device is locked to the needle.

19. The apparatus of claim 1, wherein the apparatus comprises an injection device that comprises an adaptor for locking the injection device to the needle.

20. The apparatus of claim 19, wherein the injection device comprises a syringe and wherein the syringe and needle comprise interlocking luer hubs.

21. The apparatus of claim 19, wherein the injection device contains the bulking agent.