Gynecologic embolotherapy methods

• US 6,059,766 A
• Filed: 02/27/1998
• Issued: 05/09/2000
• Est. Priority Date: 02/27/1998
• Status: Expired due to Term

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Micro Therapeutics, Inc. (Medtronic Plc)
• Inventors: Greff, Richard J.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US09/032,636
• Time in Patent Office: 802 Days
• Field of Search: 604/264, 604/500, 604/506-508, 604/514, 604/515, 604/272, 604/275, 604/279
• US Class Current: 604/515
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 24/06 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L24/043, A61L24/046 take precedence
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Abstract

This invention is directed to novel methods for gynecologic embolotherapy. The methods directly access the blood vessels to be embolized transcervically rather than arterially. The methods provide precise directed delivery of embolizing compositions, and are particularly suited for treating uterine fibroids. Kits containing one or more devices for transcervical injection and an embolizing composition are also provided. In a preferred embodiment, fluid embolizing compositions are used. In a more preferred embodiment, these fluid embolic compositions comprise a biocompatible polymer, a biocompatible solvent and a biocompatible water insoluble contrast agent. In a most preferred embodiment, the contrast agent is characterized by having an average particle size of about 10 μm or less.

Claims

1. A method for gynecological embolization comprising:

(a) inserting a catheter capable of penetrating a blood vessel through the cervix into the uterus using a device which allows visualization of the uterine wall;

(b) inserting the catheter through the cervix and into a blood vessel to be embolized; and

(c) delivering an embolic material through the catheter into the vessel.

2. The method of claim 1 wherein said device allowing visualization is a hysteroscope.

3. The method of claim 1 wherein said catheter is needle tipped.

4. The method of claim 1 wherein the blood vessel is a blood vessel of a uterine fibroid.

5. The method of claim 1 wherein the embolic material is selected from the group consisting of sclerosing embolic materials, particulate embolic materials and fluid embolic materials.

6. The method of claim 1 further comprising the steps of:

(a) delivering a detectable agent through the catheter after it has been inserted into the vessel; and

(b) detecting the agent to confirm that the catheter has the proper placement in the vessel prior to delivery of embolic material.

7. The method of claim 1 wherein the embolizing composition is a fluid embolizing composition comprising:

(a) from about 2.5 to about 8.0 weight percent of a biocompatible polymer;

(b) from about 10 to about 40 weight percent of a water insoluble, biocompatible contrast agent having an average particle size of about 10 μ

m or less; and

(c) from about 52 to about 87.5 weight percent of a biocompatible solvent

wherein the weight percent of the polymer, contrast agent and biocompatible solvent is based on the total weight of the complete composition.

8. The method according to claim 7 wherein said biocompatible solvent is selected from the group consisting of dimethylsulfoxide, ethanol and acetone.

9. The method according to claim 8 wherein said biocompatible solvent is dimethylsulfoxide.

10. The method according to claim 7 wherein said water insoluble contrast agent is selected from the group consisting of tantalum, tantalum oxide, tungsten and barium sulfate.

11. The method according to claim 10 wherein said contrast agent is tantalum.

12. The method according to claim 7 wherein said biocompatible polymer is selected from the group consisting of cellulose acetates, ethylene vinyl alcohol copolymers, hydrogels, polyacrylonitrile, polyvinylacetate, cellulose acetate butyrate, nitrocellulose, copolymers of urethane/carbonate, copolymers of styrene/maleic acid, and mixtures thereof.

13. The method according to claim 12 wherein said biocompatible polymer is an ethylene and vinyl alcohol copolymer.

14. The method according to claim 13 wherein said contrast agent has an average particle size of from 1 to 10 microns.