Apparatus and method for connecting a conduit to a hollow organ
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-017/11
A61B-017/03
출원번호
US-0086577
(2005-03-23)
등록번호
US-7510561
(2009-03-31)
발명자
/ 주소
Beane,Richard M.
Brown,John W.
Crunkleton,James Alan
Gammie,James S.
Smith, Jr.,Joseph L.
출원인 / 주소
Correx, Inc.
대리인 / 주소
Pandiscio & Pandiscio
인용정보
피인용 횟수 :
22인용 특허 :
18
초록▼
An apparatus and method for connecting a first conduit to the heart without the need for cardiopulmonary bypass. The first conduit may then be attached to a second conduit that has a prosthetic device interposed. The second conduit may be connected to the aorta prior to the first conduit being attac
An apparatus and method for connecting a first conduit to the heart without the need for cardiopulmonary bypass. The first conduit may then be attached to a second conduit that has a prosthetic device interposed. The second conduit may be connected to the aorta prior to the first conduit being attached to the heart. The prosthetic device may be a prosthetic valve or a pump, for example. The apparatus of the present invention includes an implantable connector with first conduit component, a retractor expansion component, a coring component, and a pushing component. The retractor expansion component is slideably coupled to the coring component. The retractor expansion component serves to seat against and separate the inside apical wall of the left ventricle so that the coring component may cut cleanly through the myocardium to form a tissue plug without leaving any hanging attachments to the inside walls. By remaining seated against the inside wall, the retractor expansion component follows the tissue plug into the coring component. The surgeon applies force and rotary motion to the pushing component sufficient to cut the tissue plug and implant the prosthetic component.
대표청구항▼
What is claimed is: 1. A connector conduit in combination with an applicator for forming a hole in a wall of a hollow organ and for inserting the connector conduit into the hole to facilitate connection of the connector conduit to the hollow organ, said combination comprising: a hole forming elemen
What is claimed is: 1. A connector conduit in combination with an applicator for forming a hole in a wall of a hollow organ and for inserting the connector conduit into the hole to facilitate connection of the connector conduit to the hollow organ, said combination comprising: a hole forming element adapted to form a hole in the wall of the organ, said hole forming element including a cutting element on a distal end thereof; a retractor element disposed at least partially within said hole forming element, said retractor element comprising a tip at a distal end thereof adapted to penetrate the wall of the organ, and an expansion element positioned near the distal end, said expansion element having a plurality of expansion states; a sequencing means for coordinating expansion of said expansion element between said expansion states based on the position of said retractor element relative to said hole forming element; a mounting element coupled to said hole forming element, said mounting element being configured to support a connector conduit, and a connector conduit supported on said mounting element, whereby said connector conduit is positioned relative to said cutting element such that, when the hole is formed in the wall of the hollow organ, said connector conduit is inserted through the wall of the hollow organ, thereby facilitating connection of said connector conduit to the hollow organ. 2. The combination of the connector conduit and the applicator of claim 1, wherein said cutting element is a cutting blade. 3. The combination of the connector conduit and the applicator of claim 1, further comprising an occluding means for preventing excessive blood loss while the connector conduit is inserted into the hollow organ, such that the hollow organ remains at substantially normal physiological pressures during insertion of the connector conduit into the hollow organ. 4. The combination of the connector conduit and the applicator of claim 3, wherein said occluding means comprises an outer diameter of at least a portion of said retractor element and an inner diameter of at least a portion of said hole forming element. 5. The combination of the connector conduit and the applicator of claim 1, wherein the hollow organ is a beating heart. 6. The combination of the connector conduit and the applicator of claim 1, wherein said cutting element extends from said connector conduit whereby, when a hole is formed in the wall of the hollow organ with said cutting element, said connector conduit is inserted through the wall of the hollow organ in a single motion. 7. The combination of the connector conduit and the applicator of claim 1, wherein the position of said connector conduit on said mounting element is fixed relative to said hole forming element. 8. The combination of the connector conduit and the applicator of claim 1, wherein the distal end of said retractor element defines a blunt tip. 9. The combination of the connector conduit and the applicator of claim 1, wherein said mounting element has a diameter that is substantially equal to an inner diameter of said connector conduit. 10. The combination of the connector conduit and the applicator of claim 1, wherein said retractor element includes a protective stopper element disposed distally of said cutting element when said retractor element is in a distal position with respect to said cutting element to thereby protect tissue from being damaged by said cutting element during insertion of said retractor element into the organ. 11. The combination of the connector conduit and the applicator of claim 1, wherein said plurality of expansion states include an unexpanded state, a fully expanded state, and at least one partially expanded state. 12. The combination of the connector conduit and the applicator of claim 1, wherein said expansion element is a balloon. 13. The combination of the connector conduit and the applicator of claim 12, wherein said balloon, when substantially fully expanded, is in the shape of a circular toroid. 14. The combination of the connector conduit and the applicator of claim 1, wherein said expansion element is an umbrella mechanism. 15. The combination of the connector conduit and the applicator of claim 1, wherein said sequencing means comprises a means for expanding said expansion element between said plurality of expansion states. 16. The combination of the connector conduit and the applicator of claim 15, wherein said means for expanding comprises a syringe in fluid communication with said expansion element. 17. The combination of the connector conduit and the applicator of claim 15, wherein said means for expanding comprises a cylinder having a piston slideable therein and coupled to said expansion element. 18. The combination of the connector conduit and the applicator of claim 15, wherein said retractor element comprises a cylinder portion and a retractor mounting portion extending from a distal end of said cylinder portion, said expansion element being disposed on said retractor mounting portion, and wherein said sequencing means comprises a sequencing bolt coupled to said means for expanding. 19. The combination of the connector conduit and the applicator of claim 18, further comprising a pusher assembly comprising a pushing element configured to transmit axial and torsional force to said connector conduit, said sequencing means further comprising a first slot formed in said pusher assembly, said sequencing bolt extending through said first slot and being movable in said first slot. 20. The combination of the connector conduit and the applicator of claim 18, wherein said sequencing means further comprises a syringe in fluid communication with said expansion element, and wherein said syringe is in fluid communication with said expansion element via an axial passageway defined in said retractor mounting portion. 21. The combination of the connector conduit and the applicator of claim 20, wherein said sequencing bolt has a passage formed therethrough that is in fluid communication with said syringe to facilitate purging and filling of said expansion element. 22. The combination of the connector conduit and the applicator of claim 1, wherein said sequencing means comprises means for moving said retractor element relative to said hole forming element whereby said expansion element is moved from a position distally outside of said hole forming element to a position at least partially disposed within said hole forming element. 23. The combination of the connector conduit and the applicator of claim 1, further comprising a pusher assembly coupled to said hole forming element, said pusher assembly comprising a pusher element configured to transmit axial and torsional force applied by a surgeon to said connector conduit, whereby the surgeon can cut a hole in the wall of the hollow organ and insert said connector conduit into the organ with the same motion. 24. The combination of the connector conduit and the applicator of claim 23, wherein said pusher assembly further includes a handle attached to said pushing element for facilitating application of axial and torsional forces necessary to cut the tissue and position said connector conduit in the wall of the hollow organ. 25. The combination of the connector conduit and the applicator of claim 23, further comprising an indexing element formed on said connector conduit and a mating element formed on said pusher assembly to maintain said connector conduit in a predetermined position with respect to said hole forming element during cutting of the tissue and insertion of said connector conduit in the wall of the hollow organ. 26. The combination of the connector conduit and the applicator of claim 1, wherein said sequencing means comprises a cam mechanism. 27. The combination of the connector conduit and the applicator of claim 1, wherein said sequencing means comprises a gear mechanism. 28. The combination of the connector conduit and the applicator of claim 1, wherein said sequencing means comprises at least one servo mechanism and a controller operatively coupled to said at least one servo mechanism. 29. The combination of the connector conduit and the applicator of claim 28, wherein said controller comprises a microprocessor based device. 30. The combination of the connector conduit and the applicator of claim 29, further comprising a button operatively coupled to said sequencing means for activating said sequencing means upon depression of the button to thereby accomplish steps of a procedure for implanting said connector conduit within the organ wall. 31. The combination of the connector conduit and the applicator of claim 1, wherein, in at least one of said expansion states, said expansion element has a diameter that is smaller than the diameter of said hole forming element. 32. The combination of the connector conduit and the applicator of claim 1, wherein, in at least one of said expansion states, said expansion element has a diameter that is larger than the diameter of said cutting element. 33. The combination of the connector conduit and the applicator of claim 1, wherein, in at least one of said expansion states, said expansion element has a diameter that is smaller than the diameter of said hole forming element, and large enough to cause said expansion element to retain a tissue plug extracted from the hole formed in the wall of the hollow organ within said hole forming element, thereby allowing the applicator and the tissue plug to be removed from the wall of the organ after insertion of said connector conduit. 34. The combination of the connector conduit and the applicator of claim 1, further comprising a removable protection element disposed adjacent said cutting element to facilitate loading of said connector conduit onto the applicator prior to a procedure. 35. The combination of the connector conduit and the applicator of claim 1, further comprising a compression tool removable and slidably disposed over said expansion element and to allow said connector conduit to be mounted onto said hole forming element without damage from said cutting element. 36. The combination of the connector conduit and the applicator of claim 1, wherein the relative rotational position of the expansion element and the hole forming element are fixed while the hole is formed by said hole forming element. 37. The combination of the connector conduit and the applicator as recited in claim 1, further comprising means for damping relative motion of the retractor element with respect to the hole forming element. 38. The combination of the connector conduit and the applicator of claim 1, further comprising a biasing element to move said retractor element relative to said hole forming element. 39. The combination of the connector conduit and the applicator of claim 38, wherein said biasing element comprises a spring. 40. An applicator for forming a hole in a wall of a hollow organ and for inserting a connector conduit into the hole to facilitate connection of the connector conduit to the hollow organ, said applicator comprising: a hole forming element adapted to form a hole in the wall of the organ, said hole forming element including a cutting element on a distal end thereof; a pusher assembly comprising a first slot, a second slot, and a pushing element, said pushing element being configured to transmit axial and torsional force to a connector conduit; a retractor element disposed at least partially within said hole forming element, said retractor element comprising: a tip at a distal end thereof adapted to penetrate the wall of the organ; a cylinder portion; a retractor mounting portion extending from a distal end of said cylinder portion; an expansion element disposed on said retractor mounting portion and positioned near the distal end of said retractor element, said expansion element having a plurality of expansion states; and a retractor follower formed on said retractor element and movably disposed in said second slot of said pusher assembly; a sequencing means for coordinating expansion of said expansion element between said expansion states based on the position of said retractor element relative to said hole forming element, said sequencing means comprising: a means for expanding said expansion element between said plurality of expansion states; and a sequencing bolt coupled to said means for expanding, said sequencing bolt extending through said first slot of said pusher assembly and being movable in said first slot of said pusher assembly; and a mounting element coupled to said hole forming element, said mounting element being configured to support a connector conduit, whereby a connector conduit is positioned relative to said cutting element such that, when the hole is formed in the wall of the hollow organ, a connector conduit is inserted through the wall of the hollow organ, thereby facilitating connection of the connector conduit to the hollow organ. 41. The applicator of claim 40, wherein said sequencing means further comprises a cam slot formed in said cylinder portion of said retractor element, said sequencing bolt extending through said cam slot and being movable within said cam slot. 42. The applicator of claim 41, wherein said sequencing bolt is movable between a first and second position in said first slot to move said sequencing bolt in said cylinder portion of said retractor element and coordinate expansion of said expansion element to a fully expanded state while said retractor follower in said second slot remains locked with said retractor element in a fully extended position relative to said hole forming element. 43. The applicator of claim 42, wherein said sequencing bolt is movable between the second position and a third position in said first slot and in said cam slot to lock said expansion element in the fully expanded state. 44. The applicator of claim 43, wherein said sequencing bolt is movable between the third position and a fourth position in said first slot, such that when said sequencing bolt is moved to the fourth position said retractor follower is simultaneously moved within said second slot to enable said retractor element to move with respect to said hole forming element. 45. The applicator as recited in claim 44, wherein movement of said sequencing bolt from the first position to the fourth position can be accomplished manually in a substantially continuous manner. 46. The applicator of claim 44, wherein said sequencing bolt is movable between the fourth position and a fifth position in said first slot, such that said retractor element is simultaneously moved with respect to said hole forming element to position the organ wall between said expansion element and said cutting element, whereby upon manipulation of said pusher assembly, a hole in the tissue is cut by said hole forming element and the connector conduit is moved into the hole. 47. The applicator of claim 46, further comprising means for automatically accomplishing movement of said sequencing bolt between the fourth position and the fifth position. 48. The applicator of claim 46, wherein said sequencing bolt is movable between the fifth position and a sixth position in said first slot and said cam slot, wherein at said sixth position, said sequencing bolt is moved with respect to said cylinder portion, whereby said expansion element is in a partially expanded state, and said retractor element moves in a proximal direction with respect to said hole forming element until said expansion element is at least partially disposed within said hole forming element. 49. The applicator of claim 48, further comprising means for automatically accomplishing movement of said sequencing bolt between said fifth position and said sixth position. 50. The applicator of claim 48, further comprising a biasing element coupled to said retractor element and said pushing element to bias said retractor element in a proximal direction with respect to said pushing element and thereby automatically move said sequencing bolt from said fourth position to said fifth position and from said fifth position to said sixth position. 51. The applicator as recited in claim 50, wherein said biasing element is a spring. 52. The applicator as recited in claim 41, wherein said sequencing means comprises means for causing the elements to assume the following states in seriatim; a) a first state in which the sequencing bolt is moved in the first slot and the cam slot to expand the expansion element while the retractor element is locked in a fully extended position relative to the hole forming element; b) a second state in which the sequencing bolt is moved in the first slot and the cam slot to retain the expansion element as fully expanded; c) a third state in which the sequencing bolt moves in the first slot and the retractor follower moves in the second slot to release the retractor element and permit a biasing element to move the retractor element toward the hole forming element; and d) a fourth state in which the sequencing bolt moves in the first slot while being locked in the cam slot and the retractor follower moves in the second slot to complete forming of the hole and allow insertion of the connector conduit into the hole; and e) a fifth state in which the sequencing bolt moves in the first slot and in the cam slot to release the sequencing bolt from a locked position in the cam slot to allow the expansion element to assume the partially expanded state while the expansion element is moved to be at least partially disposed in the hole forming element. 53. The combination of the connector conduit and the applicator of claim 52, wherein said biasing element comprises a spring. 54. An applicator for forming a hole in a wall of a hollow organ and for inserting a connector conduit into the hole to facilitate connection of the connector conduit to the hollow organ, said applicator comprising: a hole forming element adapted to form a hole in the wall of the organ, said hole forming element including a cutting element on a distal end thereof; a retractor element disposed at least partially within said hole forming element, said retractor element comprising a tip at a distal end thereof adapted to penetrate the wall of the organ, and an expansion element positioned near the distal end, said expansion element having a plurality of expansion states; a sequencing means for coordinating expansion of said expansion element between said expansion states based on the position of said retractor element relative to said hole forming element; and a mounting element coupled to said hole forming element, said mounting element being configured to support a connector conduit, whereby the connector conduit is positioned relative to said cutting element such that, when the hole is formed in the wall of the hollow organ, the connector conduit is inserted through the wall of the hollow organ, thereby facilitating connection of the connector conduit to the hollow organ, wherein said sequencing means comprises means for causing the elements to assume the following states in seriatim; a) a first state where the retractor element is locked in a fully extended position relative to the hole forming element with the expansion element in the unexpanded state; b) a second state in which the expansion element is in the fully expanded state and the expansion element moves toward the hole forming element; c) a third state in which the hole has been formed and the connector conduit has been inserted; and d) a fourth state in which the expansion element is in the partially expanded state and the expansion element is moved to be at least partially disposed in the hole forming element.
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