IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0400817
(1999-09-22)
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§371/§102 date |
20030117
(20030117)
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발명자
/ 주소 |
|
대리인 / 주소 |
|
인용정보 |
피인용 횟수 :
2 인용 특허 :
15 |
초록
▼
A method is provided of forming a cervical cap in situ, i.e., within a patient's body, which cap will substantially completely conform to the shape of the patient's cervix, allowing the cap to be left in place over an extended period of time. The method of the invention includes the steps of positio
A method is provided of forming a cervical cap in situ, i.e., within a patient's body, which cap will substantially completely conform to the shape of the patient's cervix, allowing the cap to be left in place over an extended period of time. The method of the invention includes the steps of positioning a snugly fitting rim member around the patient's exocervix, mounting a shell member, having an aperture, onto the rim member such that the rim member, shell member and exocervix define a cavity, and injecting a curable material through the aperture to substantially fill the cavity. After the curable material is allowed to harden, the entire assembly is removed from the patient and the shell removed from the cured material.
대표청구항
▼
1. A cervical cap comprising: (a) a cap body that is constructed to cover a patient's exocervix and prevent ingress of sperm and fluids and comprises a cap dome that is custom-molded to substantially completely conform to the shape of said exocervix, (b) a rim member, dimensioned to snugly fit said
1. A cervical cap comprising: (a) a cap body that is constructed to cover a patient's exocervix and prevent ingress of sperm and fluids and comprises a cap dome that is custom-molded to substantially completely conform to the shape of said exocervix, (b) a rim member, dimensioned to snugly fit said exocervix, from which the cap body extends, and (c) a portion, associated with said cap body, that is impregnated or coated with a therapeutic agent and is constructed to release said therapeutic agent over a period of time during use of said cap, wherein said portion comprises a removable ring that is press-fit onto said cap adjacent said rim member.2. The cervical cap of claim 1, wherein said therapeutic agent is selected from the group consisting of microbicides, spermicides, medications, and combinations thereof.3. The cervical cap of claim 1, wherein said therapeutic agent is an iodine complex.4. The cervical cap of claim 1, wherein said therapeutic agent functions as both a spermicide and a microbicide.5. The cervical cap of claim 1, said cap further comprising a valve constructed to allow outflow from said cap body while preventing fluid flow into said cap body.6. The cervical cap of claim 5, wherein said valve is selected from the group consisting of check valves and collapsed tube valves.7. The cervical cap of claim 5, wherein said valve comprises a membrane disposed over an outer surface of said cap body.8. The cervical cap of claim 1, wherein said portion is replaceable.9. The cervical cap of claim 8, wherein said portion is removable.10. A method of protecting the exocervix of a female, said method comprising:(a) applying to said exocervix a custom-molded cervical cap comprising (i) a cap body comprising a cap dome that is custom-molded to substantially completely conform to the shape of said exocervix and is constructed to cover said exocervix and prevent ingress of sperm and fluids, (ii) a rim member dimensioned to snugly fit said exocervix, and (iii) a portion comprising a removable ring, wherein said portion is impregnated or coated with a therapeutic agent and is constructed to slowly release said therapeutic agent during use of said cap; (b) press-fitting said ring onto an outer surface of said cervical cap; and (c) applying said portion to said cervical cap so that said portion is removable and replaceable. 11. The method of claim 10, wherein said therapeutic agent is selected from the group consisting of microbicides, spermicides, mediations, and combinations thereof.12. A method of measuring the diameter of an exocervix of a patient comprising the steps of:(a) providing a ring gauge comprising a plurality of ring members having different diameters and means for positioning a selected ring member onto said patient's exocervix; (b) inserting said ring gauge into the vagina of said patient; (c) positioning one of said ring members around said patient's exocervix and determining whether said selected rim member fits said exocervix; and (d) repeating steps (a)-(c) with ring members having different diameters until said selected ring member fits said exocervix, with the diameter of said selected ring member corresponding to the diameter of said exocervix. 13. The method of claim 12, wherein said positioning means comprises a pair of elongated members adapted to be removably and rotatably attached to one of said ring members.14. The method of claim 12, wherein said gauge further comprises means for measuring and said method further comprises the step of (e) positioning said measuring means to determine the depth of said exocervix.15. The method of claim 14, wherein said positioning means comprises a pair of elongated members adapted to be removably and rotatably attached to one of said ring members and said measuring means comprises a measuring member movably mounted on one of said elongated members.16. The method of claim 12, said method further comprising the steps of, prior to inserting said ring gauge:(a) inserting a cervical plunger comprising a plunger member and a tube member in fluid communication with said plunger member; (b) placing said cervical plunger on said exocervix; (c) drawing a vacuum through said tube member to draw said exocervix against an inner surface of said plunger member; and (d) positioning said exocervix by moving the tube member. 17. A kit for use by a clinician in forming a custom cervical cap in situ in a patient's body, comprising a ring gauge and a rim member dimensioned to fit an exocervix, said rim member including a substantially ring-shaped surface that, when said rim member is placed on said exocervix, faces toward the opening of the patient's vagina; a curable material; and means for applying said curable material.18. A kit for use by a clinician in forming a custom cervical cap in situ in a patient's body, comprising a ring gauge, a rim member dimensioned to fit an exocervix, a shell member dimensioned to be mounted on said rim member, a curable material, and means for applying said curable material.19. A kit for use by a clinician in forming a custom cervical cap in situ in a patient's body comprising a rim member dimensioned to fit an exocervix, a ring gauge, a curable material, and means for applying said curable material.20. A cervical cap comprising:a rim member dimensioned to snugly fit a patient's exocervix; a cap dome extending from said rim member to cover the exocervix and having an opening to allow fluid out of said cap dome, said cap dome being custom-molded to substantially completely conform to the shape of said exocervix; and a valve associated with said opening, constructed to allow outflow while preventing flow into said cap dome, wherein said rim member and said cap dome are of different chemical compositions. 21. The cervical cap of claim 20, wherein said rim member comprises MED 54220 silicone or MED 4860 silicone and said dome comprises SILASTIC 382 silicone or MED 64220 silicone.22. The cervical cap of claim 20, wherein said valve comprises a check valve sealingly positioned in said opening.23. The cervical cap of claim 22, wherein said check valve is a duckbill valve.24. The cervical cap of claim 20, wherein said valve comprises a collapsed tube valve.25. The cervical cap of claim 20, wherein said valve comprises a membrane disposed over an outer surface of said dome and sealed to said cap dome in spaced regions.26. The cervical cap of claim 25, wherein said membrane has a thickness of less than 0.5 mm.27. The cervical cap of claim 26, wherein said membrane has a thickness of less than 0.25 mm.28. The cervical cap of claim 25, wherein said membrane comprises a silicone polymer.29. The cervical cap of claim 20, wherein said rim member comprises circumferential ridges on its inner surface.30. The cervical cap of claim 20, said cap further comprising a portion that is impregnated or coated with a therapeutic agent and that is constructed to slowly release said therapeutic agent during use of said cap.31. The cervical cap of claim 30, wherein said portion is removable.32. The cervical cap of claim 31, wherein said portion is a removable ring that is press-fit onto the cap adjacent said rim member.33. The cervical cap of claim 30, wherein said therapeutic agent is selected from the group consisting of microbicides, spermicides, medications, and combinations thereof.34. The cervical cap of claim 30, wherein said therapeutic agent is an iodine complex.35. The cervical cap of claim 20, wherein said cap dome comprises a cured polymeric material.36. The cervical cap of claim 20, wherein said portion is removable.
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