IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0854534
(2007-09-12)
|
등록번호 |
US-8617204
(2013-12-31)
|
발명자
/ 주소 |
- Khosravi, Farhad
- Pai, Suresh S.
- Bagaoisan, Celso J.
- Sershen, Scott R.
- Moreno, Marlon
- Domingo, Juan
|
출원인 / 주소 |
|
대리인 / 주소 |
|
인용정보 |
피인용 횟수 :
9 인용 특허 :
98 |
초록
▼
An apparatus for sealing a puncture through tissue to a vessel includes an elongate occlusion member including an expandable member, a cartridge carried on the occlusion member, and a sealant carried within the cartridge. The cartridge includes an outer member and a pusher member within the outer me
An apparatus for sealing a puncture through tissue to a vessel includes an elongate occlusion member including an expandable member, a cartridge carried on the occlusion member, and a sealant carried within the cartridge. The cartridge includes an outer member and a pusher member within the outer member. The sealant is disposed within the outer member adjacent the expandable member distal to the pusher member. During use, the occlusion member is introduced into a puncture until the expandable member and the sealant extend from the puncture into the vessel. The expandable member is expanded, and withdrawn until the expanded expandable member contacts the vessel wall, thereby withdrawing the sealant back into the puncture. The outer member is withdrawn to expose the sealant within the puncture, while the pusher member prevents removal of the sealant, and then the cartridge, occlusion member, and pusher member are successively removed.
대표청구항
▼
1. An apparatus for sealing a puncture extending through tissue, comprising: an elongate occlusion member comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and an expandable member on the distal end;a cartridge carried on the occlusion member, the cartridge
1. An apparatus for sealing a puncture extending through tissue, comprising: an elongate occlusion member comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and an expandable member on the distal end;a cartridge carried on the occlusion member, the cartridge comprising: an outer tubular member comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and a lumen extending between the proximal and distal ends; anda sealant disposed within the outer tubular member adjacent the expandable member in a first position, the outer member movable proximally from the first position to a second position to expose the sealant; anda transition cuff comprising a first end attached to the occlusion member distal to the expandable member and a second loose end, the second end of the cuff extending over the outer member distal end in the first position and slidable off the outer member distal end when the outer member is moved from the first position to the second position or when the expandable member is expanded. 2. The apparatus of claim 1, wherein the cartridge further comprises an inner pusher member disposed within the outer tubular member adjacent the sealant for preventing substantial proximal movement of the sealant when the outer member is moved from the first position to the second position to expose the sealant. 3. The apparatus of claim 1, further comprising a tubular sheath comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and a lumen extending between the proximal and distal ends for receiving the cartridge therethrough. 4. The apparatus of claim 1, wherein the transition cuff is sufficiently flexible to accommodate expansion of the expandable member. 5. The apparatus of claim 4, wherein the cuff extends only partially over the expandable member such that the cuff is directed distally when the expandable member is expanded. 6. The apparatus of claim 4, wherein the cuff is sufficiently expandable such that the cuff expands when the expandable member is expanded. 7. The apparatus of claim 1, wherein the sealant comprises an elongate body having a disk shape, a solid cylindrical shape, a rolled sheet cylindrical shape, or a folded sheet cylindrical shape. 8. The apparatus of claim 1, wherein the sealant comprises hydrogel. 9. The apparatus of claim 8, wherein the sealant comprises a lyophilized hydrogel comprising hydrolytically degradable bonds, the hydrogel expanding when exposed to an aqueous physiological environment. 10. The apparatus of claim 1, the sealant comprising a lumen extending between proximal and distal ends thereof for receiving the occlusion member therethrough. 11. The apparatus of claim 1, wherein the expandable member comprises a balloon. 12. The apparatus of claim 1, wherein the expandable member comprises a skin or covering such that the expandable member is substantially nonporous, and wherein the cuff extends at least partially over the skin or covering. 13. A system for sealing a puncture extending through tissue, comprising: a delivery sheath comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and a lumen extending between the proximal and distal ends;an elongate occlusion member comprising a proximal end, a distal end sized for insertion into the delivery sheath lumen, and an expandable member on the distal end;a cartridge carried on the occlusion member, the cartridge comprising: an outer member comprising a proximal end, a distal end sized for insertion into the introducer sheath lumen, and a lumen extending between the proximal and distal ends;a sealant disposed within the outer member adjacent the expandable member;an inner pusher member disposed within the outer member adjacent the sealant for preventing substantial proximal movement of the sealant; anda transition cuff comprising a first end attached to the occlusion member distal to the expandable member and a second loose end, the second end of the cuff extending over the outer member distal end in the first position and slidable off the outer member distal end when the outer member is moved from the first position to the second position or when the expandable member is expanded, the transition cuff extending at least partially over the expandable member when the outer member is directed to the second position,wherein the outer member is movable proximally from a first position where the outer member distal end covers the sealant and is disposed adjacent the expandable member, to a second position for exposing the sealant. 14. The system of claim 13, wherein the delivery sheath comprises an introducer sheath for delivering one or more instruments through the puncture into a patient's body. 15. The system of claim 13, wherein the transition cuff is sufficiently flexible to accommodate expansion of the expandable member. 16. The system of claim 15, wherein the cuff extends only partially over the expandable member such that the cuff is directed distally when the expandable member is expanded. 17. The system of claim 15, wherein the cuff is sufficiently expandable such that the cuff expands when the expandable member is expanded. 18. The system of claim 13, wherein the sealant comprises an elongate body having a disk shape, a solid cylindrical shape, a rolled sheet cylindrical shape, or a folded sheet cylindrical shape. 19. The system of claim 13, wherein the sealant comprises a lyophilized hydrogel comprising hydrolytically degradable bonds, the hydrogel expanding when exposed to an aqueous physiological environment. 20. The system of claim 13, the sealant comprising a lumen extending between proximal and distal ends thereof for receiving the occlusion member therethrough. 21. The system of claim 13, further comprising a removable stop extending between the proximal end of the outer member and the proximal end of the occlusion member for preventing proximal movement of the outer member relative to the occlusion member until the stop is removed. 22. An apparatus for sealing a puncture extending through tissue, comprising: an elongate occlusion member comprising a proximal end, a distal end sized for insertion into a puncture through tissue, and an expandable member on the distal end; anda cartridge carried on the occlusion member, the cartridge comprising: an outer tubular member comprising an outer member proximal end, an outer member distal end sized for insertion into a puncture through tissue, and a lumen extending between the outer member proximal and distal ends, the outer member movable from a first position wherein the outer member distal end at least partially covers the expandable member and a second position wherein the expandable member is exposed;an inner tubular member slidably disposed within the outer tubular member, the inner tubular member comprising inner member proximal and distal ends, the inner member distal end disposed adjacent the outer member distal end when the outer tubular member is in the second position;a sealant disposed within the inner tubular member adjacent the inner member distal end; anda housing attached to the inner member proximal end, the outer tubular member being slidable axially relative to the housing, the housing limiting axial movement of the outer tubular member between the first and second positions; anda transition cuff comprising a first end attached to the occlusion member distal to the expandable member and a second loose end, the second end of the cuff extending over the outer member distal end in the first position and slidable off the outer member distal end when the outer member is moved from the first position to the second position or when the expandable member is expanded, the transition cuff extending at least partially over the expandable member when the outer member is directed to the second position. 23. The apparatus of claim 22, further comprising a pusher member disposed within the inner tubular member adjacent the sealant for preventing substantial proximal movement of the sealant when the inner tubular member is moved proximally relative to the sealant. 24. The apparatus of claim 22, wherein at least one of the outer tubular member and the housing comprise a stop for limiting axial movement of the outer tubular member between the first and second positions. 25. The apparatus of claim 22, further comprising a removable stop, extending between the proximal end of the inner member and the proximal end of the occlusion member for preventing proximal movement of the inner member relative to the occlusion member until the stop is removed. 26. A method for sealing a puncture extending through tissue to a body lumen, comprising: providing an apparatus comprising: an elongate occlusion member including an expandable member on a distal end thereof; a tubular member slidably disposed around the occlusion member; a sealant disposed within the tubular member adjacent the expandable member, and a transition cuff comprising a first end attached to the occlusion member distal to the expandable member and a second loose end, the second end of the cuff extending over a distal end of the tubular member;introducing the occlusion member distal end into the puncture with the expandable member in a contracted condition until the expandable member and the sealant extend from the puncture into the body lumen;expanding the expandable member, whereupon the second end of the cuff slides off the distal end of the tubular member;at least partially withdrawing the occlusion member from the puncture until the expanded expandable member contact a wall of the body lumen adjacent the puncture, thereby withdrawing the sealant back into the puncture; andwithdrawing the tubular member to separate the cuff from the tubular member distal end and expose the sealant within the puncture. 27. The method of claim 26, further comprising providing a pusher member disposed within the tubular member and adjacent to the sealant for preventing substantial proximal movement of the sealant when the tubular member is withdrawn to expose the sealant. 28. The method of claim 27, wherein the pusher member remains substantially stationary when the tubular member is withdrawn to maintain the sealant substantially stationary as the sealant is exposed. 29. The method of claim 28, further comprising advancing the pusher member within the puncture after exposing the sealant to compress the sealant within the puncture. 30. The method of claim 29, wherein the sealant is compressed between the pusher member and the occlusion member. 31. A method for sealing a puncture extending through tissue to a body lumen, comprising: providing an apparatus comprising: an occlusion member comprising an expandable member on a distal end thereof; a cartridge comprising an outer member and a sealant within the outer member adjacent the expandable member; and a transition cuff comprising a first end attached to the occlusion member distal to the expandable member and a second loose end, the second end of the cuff extending over a distal end of the outer member;introducing the occlusion member distal end through the puncture into the body lumen with the cuff extending over the distal end of the outer member;retracting the outer member such that the second end of the cuff slides off the outer member distal end and exposes the expandable member within the body lumen, the cuff extending at least partially over the expandable member;expanding the expandable member within the body lumen; andat least partially withdrawing the occlusion member from the puncture until the expanded expandable member substantially seals the body lumen from the puncture. 32. The method of claim 31, further comprising withdrawing the outer member to expose the sealant within the puncture. 33. The method of claim 32, wherein the cartridge further comprises a pusher member within the outer member adjacent the sealant, the pusher member preventing substantial proximal movement of the sealant when the outer member is withdrawn to expose the sealant. 34. The method of claim 32, further comprising: providing a removable stop extending between a proximal end of the outer member and a proximal end of the occlusion member, the removable stop preventing the proximal movement of the outer member relative to the occlusion member; andremoving the removable stop before withdrawing the outer member. 35. The method of claim 33, further comprising advancing the pusher member within the puncture to compress the sealant within the puncture. 36. The method of claim 35, wherein the sealant is compressed between the pusher member and the expanded expandable member. 37. The method of claim 31, further comprising introducing a tubular sheath into the puncture until a distal end of the sheath extends into the body lumen, the occlusion member being introduced through the puncture via the tubular sheath.
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