Percutaneous perforation closure systems, devices, and methods
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-017/00
A61B-050/33
A61B-017/22
A61B-050/30
A61B-090/00
출원번호
US-0781630
(2013-02-28)
등록번호
US-9662099
(2017-05-30)
발명자
/ 주소
Grant, Peter
Martin, Christopher
Dunning, Michael
Ryan, Damien
Dolphin, Joseph
Hession, Micheál
Pawlikowski, Bartosz
McGoldrick, Mark
Brett, Ger
McCartin, Michael
Regan, Des
Murphy, Matthew
출원인 / 주소
Vivasure Medical Limited
대리인 / 주소
Choate, Hall & Stewart LLP
인용정보
피인용 횟수 :
0인용 특허 :
140
초록▼
A device for sealing an aperture in a tissue includes: an implant configured to seal the aperture when positioned adjacent to the aperture; and a delivery shaft configured to engage the implant to allow the implant to be maneuvered into sealing engagement with a distal surface of the tissue, the del
A device for sealing an aperture in a tissue includes: an implant configured to seal the aperture when positioned adjacent to the aperture; and a delivery shaft configured to engage the implant to allow the implant to be maneuvered into sealing engagement with a distal surface of the tissue, the delivery shaft comprising a retaining sleeve comprising a locking projection engagable with the locking recess of the implant to secure the implant to the delivery shaft, and a release sleeve axially slideable relative to the retaining sleeve between a first axial position in which the release sleeve is configured to maintain locking engagement between the locking recess and the locking projection, and a second axial position in which the release sleeve permits the locking projection to disengage the locking recess.
대표청구항▼
1. A device for sealing an aperture in a tissue, the device comprising: a. an implant configured to seal the aperture when positioned adjacent to the aperture (i) a foot including a distal portion configured to be disposed distally beyond a distal surface of the tissue when the device is in a sealin
1. A device for sealing an aperture in a tissue, the device comprising: a. an implant configured to seal the aperture when positioned adjacent to the aperture (i) a foot including a distal portion configured to be disposed distally beyond a distal surface of the tissue when the device is in a sealing position, and a proximal portion having a longitudinal axis and configured to extend proximally through the aperture and proximally beyond a proximal surface of the tissue when the device is in the sealing position;(ii) a thin flexible wing having at least one surface and a longitudinal plane, the flexible wing positionable against the distal surface of the tissue adjacent the aperture such that the flexible wing is disposed between the anterior distal portion of the foot and the distal surface of the tissue when the device is in the sealing position, wherein the at least one surface has a wettability that is increased from a base state of a material from which the flexible wing is formed; and(iii) an elongated retention member comprising a first portion and a second portion supported and housed by the proximal portion of the foot, the retention member slideably moveable with respect to the proximal portion of the foot from a first position to a second positionwherein the retention member, when in the first position, is substantially straight with the first portion and the second portion aligned and extended substantially parallel to the longitudinal axis of the proximal portion of the foot, andwherein the retention member, when in the second position, is curved with the first portion substantially parallel to the longitudinal axis of the proximal portion of the foot and the second portion substantially parallel to the longitudinal plane of the flexible wing and positioned against the proximal surface of the tissue adjacent the aperture;b. a delivery shaft configured to engage the implant to allow the implant to be maneuvered into sealing engagement with a distal surface of the tissue, the delivery shaft comprising: (i) a retaining sleeve comprising a locking projection engagable with a locking recess of the implant to secure the implant to the delivery shaft, and(ii) a release sleeve axially slideable relative to the retaining sleeve between a first axial position in which the release sleeve is configured to maintain locking engagement between the locking recess of the implant and the locking projection of the retaining sleeve, and a second axial position in which the release sleeve permits the locking projection of the retaining sleeve to disengage the locking recess of the implant. 2. The device according to claim 1, wherein the retaining sleeve comprises an interlocking projection configured to engage an interlocking recess of the implant when the release sleeve is in the first axial position and to disengage the interlocking recess when the release sleeve is moved from the first axial position to the second axial position. 3. The device according to claim 2, wherein the interlocking projection is one of a plurality of interlocking projections configured to engage a respective plurality of interlocking recesses of the implant. 4. The device according to claim 2, wherein the interlocking projection is biased toward a flared position such that movement of the release sleeve from the first axial position to the second axial position causes the interlocking projection to flare away from and out of engagement with the interlocking recess of the implant. 5. The device according to claim 1, wherein the device is configured such that(a) movement of an actuator from the first position to the second position causes a change in the position of two components of the implant relative to each other and(b) movement of the actuator from the second position to the first position causes the delivery shaft to release the implant. 6. The device according to claim 1, wherein the implant is formed of a polymer that remains shelf stable and functional for sealing after terminal sterilization. 7. The implant according to claim 6, wherein the polymer remains shelf stable and functional for sealing after terminal sterilization using at least one of (a) ethylene oxide, (b) electron-beam, (c) gamma irradiation, and (d) nitrous oxide. 8. The device according to claim 6, wherein the polymer is biodegradable. 9. The device according to claim 8, wherein the polymer comprises Polydioxanone, Poly-L-lactide, Poly-D-lactide, Poly-DL-lactide, Polyglycolide, ε-Caprolactone, Polyethylene glycol, or combinations of these. 10. The device according to claim 8, wherein the polymer comprises polydioxanone. 11. The device according to claim 1, wherein the device is configured to seal a perforation in a hollow vessel. 12. The device according to claim 11, wherein the implant includes an intraluminal portion configured to form a seal with the perforation by contacting an intraluminal surface of the hollow vessel. 13. The device according to claim 12, wherein the implant includes an extra-luminal portion configured to extend outside the hollow vessel, the delivery shaft being configured to engage the implant via the extra-luminal portion. 14. The device according to claim 1, wherein the implant is formed at least in part of a material having an inherent viscosity in a range from 0.5 to 7.0 dl/g. 15. The device according to claim 1, wherein a diameter of the flexible wing is greater than a diameter of the aperture in the tissue. 16. The device according to claim 1, wherein the implant comprises a distal foot portion and a recessed surface disposed in the distal foot portion and into which the flexible wing is positioned and crimped to provide an effective fluid seal between the distal foot portion and the flexible wing. 17. The device according to claim 16, wherein the crimping is achieved using at least one of (a) mechanical, (b) chemical, and (c) thermal methods. 18. The device according to claim 1, wherein the distal portion of the foot has a length that is greater than a diameter of the aperture. 19. The device according to claim 1, wherein the distal portion of the foot is configured to reinforce the flexible wing to facilitate sealing of the aperture. 20. The device according to claim 1, wherein the implant includes a guide channel configured to receive a guide wire. 21. The device according to claim 20, wherein the retention member is configured to block the guide channel when the retention member is in the second position. 22. The device according to claim 20, wherein the retention member is configured to leave the guide channel open when the retention member is in the second position. 23. The device according to claim 22, wherein the foot includes a cavity configured to allow sealing of the guide channel via coagulation after removal of a guidewire from the guide channel. 24. The device according to claim 23, further comprising: a loading funnel configured to fold the implant into an elongated folded configuration to permit the wing to pass through a procedural sheath when the delivery shaft maneuvers the implant into a location of the aperture to be sealed. 25. The device according to claim 24, wherein the tapered portion comprises a frustoconical portion and the narrowed portion comprises a cylindrical portion. 26. The device according to claim 25, wherein the frustoconical portion and the cylindrical portion are non-concentric. 27. The device according to claim 24, wherein the loading funnel includes: a tapered portion configured to progressively fold the implant into the folded configuration when the implant is maneuvered through the tapered portion in a proximal direction; anda narrowed portion configured to receive the implant with the flexible wing in the folded configuration when the implant is maneuvered further in the proximal direction and proximally beyond the tapered portion. 28. The device according to claim 27, wherein the narrowed portion comprises a cannula configured to receive the implant with the wing in the folded configuration and that can be detached from the remainder of the loading funnel. 29. The device according to claim 27, further comprising: a packaging having a proximal and a distal end, wherein the delivery shaft, the implant, and the loading funnel are disposed in the packaging such that the delivery shaft extends distally through the narrowed portion of the funnel and into the tapered portion, where the delivery shaft is coupled to the implant, and the loading funnel is held in the packaging such that proximal movement of the delivery shaft relative to the package causes, sequentially, (a) proximal movement of the implant through the tapered portion to progressively fold the implant into the folded configuration, (b) proximal movement of the implant into the cannula, and (c) separation of the cannula, with the implant disposed therein, from the remainder of the loading funnel. 30. The device according to claim 29, wherein the implant is held in the tapered portion by the delivery shaft. 31. The device according to claim 29, further comprising a handle coupled to the delivery shaft, the handle being disposed in the packaging. 32. The device according to claim 29, wherein the cannula is configured to access multiple forms of introducer sheaths. 33. A method of using the device according to claim 27, comprising: loading the implant into the cannula at the time of a surgery in which the implant is used; andinserting the cannula into a proximal access of a procedural sheath in order to introduce the implant in the folded configuration into the procedural sheath. 34. The method of claim 33, further comprising feeding a proximal end of the guidewire through the implant and the delivery shaft prior to inserting the cannula into the proximal access of the procedural sheath, such that a distal end of the guidewire extends through the aperture to be closed by the implant.
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