Bulking agents

• US 10,398,724 B2
• Filed: 11/18/2013
• Issued: 09/03/2019
• 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, Michael, Madenjian, Arthur R., Rao, Doreen, Buiser, Marcia, Li, Jianmin, Rackley, Raymond, Gellman, Barry N.
• Primary Examiner(s): Pipic, Alma
• Application Number:
  US14/082,274
• Publication Number:
  US 20140072636A1
• Time in Patent Office: 2,115 Days
• 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, ancurismal 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. A method for bulking mammalian tissue comprising the steps of:

introducing a bulking agent to the mammalian tissue, the bulking agent comprising;

a carrier, and a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier, the substantially spherical polyvinyl alcohol particles comprising surface pores covering up to 80% of the total surface area of the particles and the carrier aiding delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked; and

coapting the mammalian tissue with the substantially spherical polyvinyl alcohol particles.

2. The method of claim 1 further comprising the step of viewing the tissue to be bulked during the introducing step.

3. The method of claim 1 wherein the bulking agent comprises a volume from about 1 ml to about 30 ml.

4. The method of claim 1 wherein at least some of the substantially spherical polyvinyl alcohol particles are sized from about 40 microns to about 1500 microns in diameter.

5. The method of claim 1 wherein the substantially spherical polyvinyl alcohol particles comprise surface pores within a range of 4 to 50 microns.

6. The method of claim 1 wherein the substantially spherical polyvinyl alcohol particles comprise surface pores within a range of 5 to 30 microns.

7. The method of claim 1 wherein the substantially spherical polyvinyl alcohol particles are sized from 150 microns to 1100 microns in diameter.

8. The method of claim 1 wherein the substantially spherical polyvinyl alcohol particles are sized from 500 microns to 900 microns in diameter.

9. The method of claim 1 wherein the bulking agent is introduced into the mammalian tissue by through a needle.

10. The method of claim 9 wherein the needle is a 16 to 24 gauge needle.

11. The method of claim 9 wherein the needle is an 18 to 22 gauge needle.

12. The method of claim 1 wherein the substantially spherical polyvinyl alcohol particles comprise alginate.

13. The method of claim 1 wherein the bulking agent is delivered transurethrally to a urethra with a cystoscope comprising a light transmitting element, a working channel and a viewing element.

14. The method of claim 13 wherein the bulking agent is delivered by an elongate needle inserted through the working channel of the cystoscope.

15. The method of claim 1 wherein the bulking agent is injected around an enlarged lumen of a urethra.

16. The method of claim 1 wherein the bulking agent comprises a contrast agent.

20. The method of claim 12, wherein the substantially spherical polyvinyl alcohol particles are made by a process comprising:

forming substantially spherical droplets comprising polyvinyl alcohol and alginate;

crosslinking the polyvinyl alcohol in the substantially spherical droplets; and

subsequently removing alginate from an outer surface of the substantially spherical droplets to form substantially spherical particles that are substantially all polyvinyl alcohol.

17. A method for bulking mammalian tissue comprising:

inserting an inflation device within a portion of a mammal;

inflating the inflation device, thereby creating a void in the tissue; and

at least partially filling the void with a bulking agent that comprises a carrier and a plurality of polymeric particles dispersed within the carrier, wherein the plurality of polymeric particles comprise surface pores covering up to 80% of the total surface area of the particles.

18. The method of claim 17, wherein the polymeric particles are sized in a range of about 40 microns to about 1500 microns in diameter.

19. The method of claim 18, wherein the polymeric particles comprise polyvinyl alcohol particles having surface pores.