Claims for Patent: 9,283,108

Summary for Patent: 9,283,108

Title:	Sterilisation device
Abstract:	Apparatus for sterilization of a female mammal comprising at least one separation member for separation of a fallopian tube from a uterine cavity of the female mammal, a circulation assembly which is operatively connected to said at least one separation member, and at least one sterilization lumen which is operatively connected to said circulation assembly and debouching at a distal side of said at least one separation member, said at least one sterilization lumen being adapted for injection in use of a tissue necrotizing fluid capable of necrotizing a lining of at least a part of said fallopian tube, wherein said circulation assembly is adapted to circulate said tissue necrotizing fluid within said sterilization lumen and said fallopian tube. The apparatus allows quick, simple, safe and reliable sterilization.
Inventor(s):	Wallsten; Hans I. (Paudex, CH)
Assignee:
Application Number:	13/502,699
Patent Claims:	1. An apparatus for sterilisation of a female mammal comprising: at least one separation member for separation of a fallopian tube from a uterine cavity of the female mammal, the at least one separation member including an inflatable member, a circulation assembly which is operatively connected to said at least one separation member, and at least one sterilisation lumen which is operatively connected to said circulation assembly and debouching at a distal side of said at least one separation member, said at least one sterilisation lumen being adapted for injection in use of a tissue necrotising fluid through at least one debouching opening, the at least one debouching opening extending from an inner surface to an outer surface of a wall of the inflatable member, the tissue necrotising fluid capable of necrotising a lining of at least a part of said fallopian tube, the at least one sterilisation lumen terminating at the at least one debouching opening, wherein said circulation assembly is adapted to circulate said tissue necrotising fluid within said sterilisation lumen and said fallopian tube, and wherein the at least one sterilisation lumen is configured to isolate the tissue necrotising fluid from the inner surface of the wall of the inflatable member during the injection. 2. The apparatus according to claim 1, wherein said circulation assembly is adapted to drive a set volume of said tissue necrotising fluid back and forth into said fallopian tube during a treatment period. 3. The apparatus according to claim 2, wherein said back and forth movement is driven at a generally constant frequency. 4. The apparatus according to claim 2, wherein said circulation assembly comprises moving means connected to said sterilisation lumen and a driving mechanism, which driving mechanism in use is adapted to move said moving means back and forth, thereby oscillating said tissue necrotising fluid between said sterilisation lumen and a location within said fallopian tube. 5. The apparatus according to claim 4, wherein said circulation assembly, when stopped after a treatment period is fmished, is adapted to cause said moving means to start a back movement when a new treatment period is initiated. 6. The apparatus according to claim 4, wherein said driving mechanism is a stepper motor. 7. The apparatus according to claim 4, wherein said moving means is a flexing membrane which is positioned in line with the tissue necrotising fluid. 8. The apparatus according to claim 1, wherein said at least one separation member is adapted to separate the tubal ostium of a fallopian tube from the uterine cavity of the female mammal. 9. The apparatus according to claim 1, wherein a distal end of said at least one sterilisation lumen comprises the at least one debouching opening and, in use, is positioned in or in the proximity of said fallopian tube. 10. The apparatus according to claim 9, wherein said at least one separation member is adapted to simultaneously separate both fallopian tubes from the uterine cavity. 11. The apparatus according to claim 10, wherein said at least one sterilisation lumen includes two sterilisation lumens, each debouching in or in the proximity of a separate fallopian tube. 12. The apparatus according to claim 11, wherein said circulation assembly and said sterilisation lumens are adapted for treatment of both fallopian tubes simultaneously. 13. The apparatus according to claim 11, further comprising: a clamping device operatively connected to said sterilisation lumens and arranged to separately clamp one of said two sterilisation lumens so as to prevent passage of fluid through said one sterilisation lumen. 14. The apparatus according to claim 13, further comprising: a pressure sensor arranged to detect a fluid pressure in one of said two sterilisation lumens. 15. The apparatus according to claim 1, further comprising: an inflation assembly adapted to inflate said inflatable member by introducing an inflation fluid via at least one inflation lumen. 16. The apparatus according to claim 1, wherein said at least one sterilisation lumen is positioned within said inflatable member. 17. The apparatus according to claim 1, wherein said circulation assembly is adapted to heat said tissue necrotising fluid to a temperature of about 65-180.degree. C. 18. The apparatus according to claim 17, wherein said circulation assembly includes a heater provided on a proximal side of said at least one separation member adapted to heat said tissue necrotising fluid. 19. The apparatus according to claim 1, wherein said at least one separation member includes an ablation member for ablation of uterine tissue in the female mammal. 20. The apparatus according to claim 19, wherein said ablation member is the inflatable member. 21. The apparatus according to claim 1, further comprising: heating means provided on a proximal side of said at least one separation member for heating said tissue necrotising fluid, said heating means having a heat emitting portion and a heat receiving portion which in use of the apparatus are positioned in thermal contact with each other, and which are separable from each other. 22. The apparatus according to claim 21, wherein said apparatus is separable into a reusable unit and a disposable unit, said disposable unit being adapted to be sterile. 23. The apparatus according to claim 22, wherein said heat emitting portion is positioned in said reusable unit and said heat receiving portion is positioned in said disposable unit. 24. The apparatus according to claim 22, wherein said reusable unit comprises a regulation unit. 25. The apparatus according to claim 22, wherein said circulation assembly comprises a fluid compartment in fluid connection with said sterilisation lumen, a wall of said fluid compartment at least partly forming said heat receiving portion. 26. The apparatus according to claim 25, wherein said fluid compartment is connected to a proximal part of the sterilisation lumen via a fluid inlet opening and is connected to a distal part of the sterilisation lumen via a fluid outlet opening. 27. The apparatus according to claim 26, wherein said fluid compartment has an at least partly conical shape, comprising a wider bottom portion and a narrower top portion as seen in a vertical direction. 28. The apparatus according to claim 27, wherein said fluid inlet opening is located near the bottom portion of the fluid compartment and the outlet opening is located at the top portion of the fluid compartment. 29. The apparatus according to claim 21, wherein said heating means are heated by any of the methods chosen from the group of electric resistance heating, induction heating, microwave energy heating, and semi-conductive ceramic elements. 30. The apparatus according to claim 21, wherein said heat emitting portion is a tempered surface and is in use of the apparatus positioned in mechanical contact with the heat receiving portion. 31. The apparatus according to claim 1, wherein said circulation assembly is adapted to heat said tissue necrotising fluid to a temperature of about 75-90.degree. C. 32. The apparatus according to claim 1, wherein said at least one separation member is configured to isolate the fallopian tube from the uterine cavity of the female mammal. 33. The apparatus according to claim 1, wherein an inner surface of the at least one sterilisation lumen is distinct from the inner surface of the wall of the inflatable member. 34. A method for sterilisation of a female mammal, comprising steps of: (a) separating the tubal ostium of a fallopian tube from the uterine cavity of the female mammal, the separating including an inflation of an inflatable member by introduction of an inflation fluid into the inflatable member; (b) after the separating, injecting a tissue necrotising fluid via an sterilisation lumen at a position which is in communication with said fallopian tube, the injecting being performed through a debouching opening, the debouching opening extending from an inner surface to an outer surface of a wall of the inflatable member, the sterilisation lumen terminating at the debouching opening; and (c) after the injecting, circulating said tissue necrotising fluid within said sterilisation lumen and said fallopian tube, wherein the sterilisation lumen is configured to isolate the tissue necrotising fluid from the inner surface of the wall of the inflatable member during the injection. 35. The method according to claim 34, wherein the step of circulating said tissue necrotising fluid comprises oscillating a set volume of said tissue necrotising fluid back and forth into said fallopian tube. 36. The method according to claim 35, wherein the step of oscillating is accomplished by a driving mechanism connected to moving means such that said tissue necrotising fluid is moving back and forth between said sterilisation lumen and a location within said fallopian tube. 37. The method according to claim 35, wherein said volume of tissue necrotising fluid is set prior to initiation of a treatment period by (b1) injecting said tissue necrotising fluid in to said fallopian tube until it is essentially filled, and (b2) retracting a predefined volume of said tissue necrotising fluid. 38. The method according to claim 34, wherein both fallopian tubes of a female mammal are simultaneously separated from said uterine cavity. 39. The method according to claim 38, wherein steps (b) and (c) are performed on each fallopian tube separately. 40. The method according to claim 34, wherein said tissue necrotising fluid during circulation thereof into the fallopian tube is heated to a temperature of 65-180.degree. C. 41. The method according to claim 34, wherein said tissue necrotising fluid comprises a fluid selected from the group consisting of sterile water, saline, glycerine, glucose, mannitol, glycerine based liquids, and combinations thereof. 42. The method according to claim 34, comprising, before step (c), a step of (b1) injecting a fluid into the fallopian tube via said sterilisation lumen and monitoring a fluid pressure within the sterilisation lumen for determining whether the fallopian tube is open or closed. 43. The method according to claim 34, further comprising: ablating uterine tissue in the female mammal. 44. The method according to claim 43, wherein said step of ablating uterine tissue is performed using said inflatable member. 45. The method according to claim 34, wherein the method is performed with an apparatus including at least one separation member for separation of said fallopian tube from said uterine cavity of the female mammal, a circulation assembly which is operatively connected to said at least one separation member, and said sterilisation lumen which is operatively connected to said circulation assembly and debouching at a distal side of said at least one separation member, said at least one sterilisation lumen being adapted for injection in use of said tissue necrotising fluid capable of necrotising a lining of at least a part of said fallopian tube, wherein said circulation assembly is adapted to circulate said tissue necrotising fluid within said sterilisation lumen and said fallopian tube. 46. The method according to claim 34, wherein said tissue necrotising fluid during circulation thereof into the fallopian tube is heated to a temperature of 75-90.degree. C.

Details for Patent 9,283,108

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2029-11-26