Tissue eversion apparatus and tissue closure device and methods for use thereof
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-017/00
A61B-017/11
출원번호
US-0111403
(2011-05-19)
등록번호
US-9414822
(2016-08-16)
발명자
/ 주소
Ziobro, John M.
Roorda, Wouter E.
출원인 / 주소
ABBOTT CARDIOVASCULAR SYSTEMS, INC.
대리인 / 주소
Workman Nydegger
인용정보
피인용 횟수 :
0인용 특허 :
182
초록▼
Methods and apparatuses for closure of vascular punctures or other openings in bodily tissues. The apparatuses and methods described herein are configured for everting a portion of tissue around a puncture site for wound closure on the external surface of the wound. For example, the tissue eversion
Methods and apparatuses for closure of vascular punctures or other openings in bodily tissues. The apparatuses and methods described herein are configured for everting a portion of tissue around a puncture site for wound closure on the external surface of the wound. For example, the tissue eversion apparatus may be configured for drawing up a portion of a vessel surrounding a venous or arterial puncture and orienting the inner surface of the vessel at least partially outward so that a closure element may be placed around the inverted region on the exterior surface of the vessel. In some embodiments, the devices are bioabsorbable.
대표청구항▼
1. A method of closing a puncture in a body tissue having an inner wall and an outer wall, the method comprising: positioning a tissue eversion apparatus in an opening of the puncture, the tissue eversion apparatus being configured to form an everted tissue region around the puncture, the tissue eve
1. A method of closing a puncture in a body tissue having an inner wall and an outer wall, the method comprising: positioning a tissue eversion apparatus in an opening of the puncture, the tissue eversion apparatus being configured to form an everted tissue region around the puncture, the tissue eversion apparatus including: a solid elongate member configured to be positioned in the puncture, the elongate member having a proximal end, a distal end, a distal surface, and an exterior surface extending between the distal end and the proximal end, the distal surface abutting the exterior surface at the distal end; anda tissue engaging portion comprising at least two tissue engaging prongs that extend radially outwardly in a proximal direction and that are disposed on the exterior surface of the elongate member at or near the distal end and on opposite sides of the elongate member, wherein the at least two tissue engaging prongs are configured to locate and engage a portion or portions of the tissue surrounding the puncture, and on opposite lateral sides of the opening, as the apparatus is withdrawn relative to the puncture;withdrawing a portion of the tissue eversion apparatus, which has previously passed through the opening to position the tissue eversion apparatus, proximally from the opening such that the tissue engaging prongs pierce the tissue from the inner wall towards the outer wall and draw the tissue up to form an everted tissue region around the opening in the body tissue, the tissue engaging prongs extending proximally and radially outwardly from the elongate member in a pre-deployed configuration and following engagement with the tissue and withdrawal of the elongate member proximally to form the everted tissue;positioning a closure element around at least a portion of the everted tissue region so as to close the opening; andreleasing the everted tissue region from the tissue engaging prongs. 2. The method of claim 1, wherein releasing the everted tissue region from the tissue engaging prongs comprises: further withdrawing the tissue eversion apparatus from the opening so as to fold the tissue engaging prongs distally along the exterior surface of the elongate member. 3. The method of claim 1, wherein the closure element is disposed on the exterior surface of the elongate member and deliverable therefrom. 4. The method of claim 1, wherein the closure element is disposed on the exterior surface of a tubular member that is disposed around the elongate member. 5. The method of claim 1, wherein the tubular member is associated with a pusher member configured to push the closure element off of the tubular member and onto the everted tissue region. 6. The method of claim 1, wherein positioning a closure element around at least a portion of the everted tissue region further comprises withdrawing the tissue eversion apparatus from the puncture so as to position at least a portion of the everted tissue region within an opening in the closure element and closing the opening in the closure element so as to close the tissue puncture. 7. The method of claim 6, wherein the closure element comprises a shape memory alloy. 8. The method of claim 1, wherein the tissue eversion apparatus further comprises an outer sheath configured to be disposed over the tissue engaging portion in a first position and configured to be retracted to expose the tissue engaging portion in a second position. 9. The method of claim 1, wherein the elongate member of the tissue eversion apparatus further comprises a bleed-back lumen configured to facilitate positioning of the tissue eversion apparatus inside a blood vessel. 10. The method of claim 1, wherein positioning a closure element around at least a portion of the everted tissue region further comprises closing an annular or semi-annular ring around at least a portion of the everted tissue region. 11. A method of closing a puncture in a body tissue having an inner wall and an outer wall, the method comprising: positioning a tissue eversion apparatus configured to form an everted tissue region around the puncture, the tissue eversion apparatus including: a tubular member;a solid elongate member disposed within the tubular member and being configured to be positioned in the puncture, the elongate member having a proximal end, a distal end, and an exterior surface, the exterior surface being a curved surface of the elongated member extending between the proximal end and the distal end; andat least two tissue engaging prongs extending radially outwardly in a proximal direction from the exterior surface of the elongate member at or near the distal end and with the at least two engaging prongs being opposite each other across the elongate member, in a linear fashion from a base mounted to the exterior surface to a tip of each prong, the at least two tissue engaging prongs are configured to locate and engage a portion or portions of the tissue surrounding the puncture as the apparatus is withdrawn proximally relative to the puncture;advancing the elongate member distally through the puncture and from the tubular member from a pre-deployed configuration to a deployed configuration prior to engagement with the tissue, the tissue engaging prongs extending proximally and radially outwardly from the elongate member in both the pre-deployed configuration and the deployed configuration;withdrawing a portion of the tissue eversion apparatus proximally from the puncture such that the tissue engaging prongs pierce the tissue from the inner wall to exit through the outer wall at portions of tissue surrounding the puncture and on opposite lateral sides of the puncture and draw the tissue up to form an everted tissue region around the puncture in the body tissue, the tissue engaging prongs extending proximally and radially outwardly from the elongate member in the pre-deployed configuration, following engagement with the tissue, and withdrawal of the elongate member proximally to form the everted tissue;positioning a closure element around at least a portion of the everted tissue region so as to close the puncture; andreleasing the everted tissue region from the tissue engaging prongs. 12. The method of claim 11, wherein releasing the everted tissue region from the tissue engaging prongs comprises further withdrawing the tissue eversion apparatus from the puncture to fold the tissue engaging prongs distally along the exterior surface of the elongate member. 13. The method of claim 11, wherein the tubular member is associated with a pusher member configured to push the closure element off of the tubular member and onto the everted tissue region. 14. The method of claim 11, wherein positioning a closure element around at least a portion of the everted tissue region further comprises withdrawing the tissue eversion apparatus from the puncture so as to position at least a portion of the everted tissue region within an opening in the closure element and closing the opening in the closure element so as to close the tissue puncture. 15. The method of claim 11, wherein the tissue eversion apparatus further comprises an outer sheath configured to be disposed over the tissue engaging portion in a first position and configured to be retracted to expose the tissue engaging portion in a second position. 16. The method of claim 11, wherein the elongate member of the tissue eversion apparatus further comprises a bleed-back lumen configured to facilitate positioning of the tissue eversion apparatus inside a blood vessel. 17. The method of claim 11, wherein positioning a closure element around at least a portion of the everted tissue region further comprises closing an annular or semi-annular ring around at least a portion of the everted tissue region. 18. A method of closing a puncture in a body tissue having an inner wall and an outer wall, the method comprising: positioning a tissue eversion apparatus configured to form an everted tissue region around the puncture, the tissue eversion apparatus including: a tubular member;a solid elongate member disposed within the tubular member and being configured to be positioned in the puncture, the elongate member having a proximal end, a distal end, and an exterior surface extending from the proximal end to the distal end; anda plurality of tissue engaging prongs extending radially outwardly in a proximal direction from the exterior surface of the elongate member proximal to the distalmost end, in a linear fashion from a base mounted to the exterior surface to a tip of each prong, pairs of the plurality of the tissue engaging prongs being on opposite sides of the elongate member and opposite each other across the elongate member, the tissue engaging prongs are configured to locate and engage a portion or portions of the tissue surrounding the puncture, with pairs of the plurality of the tissue engaging prongs engaging with the portion or portions of the tissue on opposite lateral sides of the puncture, as the apparatus is withdrawn proximally relative to the puncture;advancing the elongate member distally through the puncture and from the tubular member from a pre-deployed configuration to a deployed configuration prior to engagement with the tissue, the tissue engaging prongs extending proximally and radially outwardly from the elongate member in both the pre-deployed configuration and the deployed configuration, the radial extension of the tissue engaging prongs being greater in the deployed than the pre-deployed configuration;withdrawing a portion of the tissue eversion apparatus proximally from the puncture such that the tissue engaging prongs pierce from the inner wall to exit through the outer wall the tissue and draw the tissue up to form an everted tissue region around the puncture in the body tissue, the tissue engaging prongs extending proximally and radially outwardly from the elongate member in the pre-deployed configuration, following engagement with the tissue, and withdrawal of the elongate member proximally to form the everted tissue;positioning a closure element around at least a portion of the everted tissue region so as to close the puncture; andreleasing the everted tissue region from the tissue engaging prongs by advancing the tubular member relative to the elongate member in a distal direction so as to move the tissue engaging prongs by pivoting the tissue engaging prongs about the base from the deployed configuration, in which the tissue engaging prongs extend in a proximal direction, to a release configuration, in which the tissue engaging prongs extend in a distal direction, and then withdrawing the tissue eversion apparatus from the puncture. 19. The method of claim 18, wherein releasing the everted tissue region from the tissue engaging prongs comprises folding the tissue engaging prongs distally along the exterior surface of the elongate member. 20. The method of claim 19, wherein positioning a closure element around at least a portion of the everted tissue region further comprises withdrawing the tissue eversion apparatus from the puncture so as to position at least a portion of the everted tissue region within an opening in the closure element and closing the opening in the closure element so as to close the tissue puncture. 21. The method of claim 20, wherein the tissue eversion apparatus further comprises an outer sheath configured to be disposed over the tissue engaging portion in a first position and configured to be retracted to expose the tissue engaging portion in a second position. 22. The method of claim 21, wherein the elongate member of the tissue eversion apparatus further comprises a bleed-back lumen configured to facilitate positioning of the tissue eversion apparatus inside a blood vessel. 23. The method of claim 22, wherein positioning a closure element around at least a portion of the everted tissue region further comprises closing an annular or semi-annular ring around at least a portion of the everted tissue region.
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