Sterilization method and apparatus

• US 4,700,701 A
• Filed: 10/23/1985
• Issued: 10/20/1987
• Est. Priority Date: 10/23/1985
• Status: Expired due to Term

• Current Assignee: David H. Montaldi
• Original Assignee: David H. Montaldi
• Inventors: Montaldi, David H.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Hindenburg, Max F.
• Application Number:
  US06/790,532
• Time in Patent Office: 727 Days
• Field of Search: 128/1 R, 128/127, 128/130, 128/303.1, 128/303.17, 128/399-402, 604/55, 604/60
• US Class Current: 606/28
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61F 6/225 transcervical

Abstract

There has been provided a method and apparatus for sterilizing females. Cautery means, vaginally insertable into the fallopian tube of the female, destroys a portion of said mucosal lining at a selected location. An absorbable scarification means and plug means is placed in the fallopian tube at said selected location. As the scarification means is absorbed, the fallopian tube forms scar tissue radially from a muscular layer thereof whereby the fallopian tube is blocked. The plug means blocks peritoneal infiltration of the by-products of cauterization and scarification outside the fallopian tube during the absorption interval.

Claims

1. A sterilization device for destroying the mucosal lining of the fallopian tube in females comprising:

cautery means vaginally insertable into the fallopian tube of the female for destroying a portion of said mucosal lining at a selected location;

means absorbable over a selected time interval carried with and vaginally insertable simultaneously with said cautery means into the fallopian tube at said selected location including a distal plug means and proximal scarification means, said scarification means for scarifying the fallopian tube radially from a muscular layer thereof, whereby the scarification blocks the fallopian tube and said plug means for blocking peritoneal infiltration of by-products of said cauterization and scarification outside the fallopian tube during the absorption interval.

2. A sterilization device as set forth in claim 1 wherein said cautery means comprises:

electrically energizable means for providing, when energized, destructive thermal exchange with said mucosal lining for thermally destroying a portion thereof.

3. A device as set forth in claim 1 further comprising:

a catheter carrying the cautery at a free end for vaginal insertion into the fallopian tube of the female, said catheter having a remotely located control end.

4. A sterilization device as set forth in claim 3 wherein said cautery means has an opening for securing the absorbable means in a distal free end thereof, and the catheter includes means in communication with the opening for dislodging said absorbable means remotely from the distal end of said cautery whereby the catheter and cautery may be removed from the fallopian tube and the absorbable means remains in the vicinity of the thermally destroyed mucosal lining.

5. A sterilization device as set forth in claim 4 wherein said cathether means includes a sleeve and a core slideably mounted therein, one end of the core being in abutment with the absorbable means and a remote end being located near the control end, said sleeve and core being relatively moveable so as to dislodge absorbable means from the cautery adjacent the thermally destroyed mucosal lining.

6. A sterilization device as set forth in claim 1 wherein the scarification means includes copper sulfate.

7. A sterilization device as set forth in claim 1 wherein the absorbable means includes polyglycolic acid.

8. A sterilization device as set forth in claim 1 wherein the absorbable means includes polyglycolic acid and the scarification means further includes copper sulfate in matrix with a portion of said polyglycolic acid.

9. A sterilization device as set forth in claim 1 wherein the cautery means comprises a peltier device.

10. A sterilization device as set forth in claim 9 wherein said peltier device includes a cylindrical metal substrate and having a cylindrical axial forward opening for receiving the absorbable means, said substrate being operatively attached to the catheter means whereby the absorbable means may be dislodged therefrom.

11. A sterilization device as set forth in claim 10 wherein at least one surface of peltier device has a coating of a metal different from the substrate and further comprising:

electrical leads, coupled one each to the substrate and the coating, extending externally of the fallopian tube and electrical control means coupled to the leads for electrically energizing the peliter device.

12. A sterilization device set forth in claim 1 wherein said plug means includes a dilating forward end.

13. A vaginally inserted sterilization device for destroying the mucosal lining of the fallopian tube and exposing an underlying portion of a muscle layer thereof in females comprising;

catheter means having a free end and a remotely located control end;

cautery means carried by the free end of the catheter means for providing destructive thermal exchange with a portion of said mucosal lining whereby said underlying portion of the muscle layer is exposed; and

means absorbable over a selected time interval mounted within and forward of said cautery means including chemoscarification means, said chemoscarification means for chemically irritating the exposed muscle layer of the fallopian tube such that scar tissue forms in said tube to thereby block the same, said absorbable means further including plug means at least forward of said chemoscarification means for blocking peritoneal infiltration of by-products of said destructive thermal exchange and scarification.

14. A sterilization device for destroying the mucosal lining of the fallopian tube in females comprising:

catheter means having a free end which may be vaginally inserted into the fallopian tube of the female and a remotely located control end;

an electrically energizable cautery means carried by the free end of the catheter means for providing, when energized, destructive thermal exchange with said mucosal lining for thermally destroying a portion thereof;

absorbable means, absorbable over a selected time interval mounted in a free end of said cautery means, said absorbable means including a distal plug means and proximal chemoscarification means, said chemoscarification means for chemically irritating the fallopian tube radially from a muscular layer thereof, and said plug means for blocking peritoneal infiltration of the scarifying chemical outside the fallopian tube during the absorption interval, whereby the scarification results in blockage of the fallopian tube.

15. A sterilization device as set forth in claim 14 wherein said catheter means includes means in operative relation with the cautery means for dislodging said absorbable means remotely from a free end of said cautery means whereby the catheter may be removed and the absorbable means remains in the vicinity of the thermally destroyed mucosal lining.

16. A sterilization device as set forth in claim 15 wherein said catheter means includes a sleeve and a core slideably mounted therein, one end of the core being in abutment with the absorbable means and a remote end being located near the control end, said sleeve and core being relatively moveable so as to dislodge absorbable means from the cautery means adjacent the thermally destroyed mucosal lining.

17. A sterilization device as set forth in claim 14 wherein the chemoscarification means includes copper sulfate.

18. A sterilization device as set forth in claim 14 wherein the absorbable means includes polyglycolic acid.

19. A sterilization device as set forth in claim 14 wherein the absorbable means includes polyglycolic acid and the chemoscarification means further includes copper sulfate in matrix with a portion of said polyglycolic acid.

20. A sterilization device as set forth in claim 14 wherein the cautery means comprises a peltier device.

21. A sterilization device as set forth in claim 20 wherein said peltier device includes a cylindrical metal substrate and having a cylindrical axial forward opening for receiving the absorbable means, said substrate being operatively attached to the catheter means whereby the absorbable means may be dislodged therefrom.

22. A sterilization device as set forth in claim 21 wherein at least one surface of peltier device has a coating of a metal different from the substrate and further comprising:

electrical leads, coupled on each to the substrate and the coating, extending to the control end and electrical control means coupled to the leads for electrically energizing the peltier device.

23. A sterilization device set forth in claim 14 wherein said plug includes a dilating forward end.

24. A sterilization device as set forth in claim 14 wherein the plug means has a rounded dilating forward free end, said plug means for dilating passages through which the catheter means is passed and for blocking peritoneal infilitration of the scarifying material outside the fallopian tube during absorption of the chemoscarification means.

25. A method of sterilizing human females by destroying the mucosal lining of the fallopian tube comprising the steps of:

vaginally inserting a cautery device together simultaneously with an absorbable means into the fallopian tube at a selected location;

cauterizing a portion of the fallopian tube by said cautery device to destroy a portion of said mucosal lining and exposing an underlying portion of muscle tissue;

exposing within said fallopian tube at the location of the cauterized portion thereof said absorbable means including a distal plug and chemoscarifying means upstream of said plug for scarifying and exposed muscle tissue of the fallopian tube radially thereof; and

blocking peritoneal infiltration of by-products associated with said cauterization and scarification by means of said distal plug.

26. A method of sterilizing human females by destroying the mucosal lining of the fallopian tube comprising the steps of:

vaginally inserting an electrically energizable cryocautery device together simultaneously with an absorbable means into the fallopian tube;

thermally destroying a portion of the tube by activating said cryocautery device;

exposing to said thermally destroyed tube portion within said fallopian tube said absorbable means including a plug downstream of said thermally destroyed tissue and chemoscarifying means upstream of said plug adjacent the thermally destoryed tissue for chemically irritating the fallopian tube radially from a muscular layer thereof in situ adjacent the thermally destroyed tube;

retaining within the fallopian tube by means of said plug, chemicals associated with said scarification means so that scarification proceeds from a muscular layer of the fallopian tube whereby a blockage occurs in said fallopian tube for sterilizing the female.