초록 ▼

A heart valve can be replaced using minimally invasive methods which include a sutureless sewing cuff that and a fastener delivery tool that holds the cuff against the patient's tissue while delivering fasteners to attach the cuff to the tissue from the inside out. The tool stores a plurality of fas

A heart valve can be replaced using minimally invasive methods which include a sutureless sewing cuff that and a fastener delivery tool that holds the cuff against the patient's tissue while delivering fasteners to attach the cuff to the tissue from the inside out. The tool stores a plurality of fasteners and is self-contained whereby a fastener is delivered and placed all from inside a vessel. The fasteners are self-forming whereby they do not need an anvil to be formed. Anchor elements are operated from outside the patient's body to cinch a prosthesis to an anchoring cuff of the valve body. The cuff is releasably mounted on the tool and the tool holds the cuff against tissue and drives the fastener through the cuff and the tissue before folding over the legs of the fastener whereby secure securement between the cuff and the tissue is assured. Fasteners are placed and formed whereby fasteners are located continuously throughout the entire circumference of the cuff. A minimally invasive surgical method is disclosed, and a method and tool are disclosed for repairing abdominal aortic aneurysms in a minimally invasive manner. Fasteners that are permanently deformed during the process of attaching the cuff are disclosed as are fasteners that are not permanently deformed during the attaching process.

대표청구항 ▼

1. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) means for securely attaching said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attache

1. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) means for securely attaching said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; andB) a tool for attaching said flexible sewing cuff to the patient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on one end of said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit,(4) means for releasably mounting said flexible sewing cuff to said tool, and(5) a fastener handling means on said housing and operationally connected to said operating handle to be controlled by said operating handle for storing said fastener and securing said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 2. The tool defined in claim 1 further including means for separating the tool from the prosthesis. 3. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate from said flexible sewing cuff, and(3) means for attaching said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been placed in a patient; andB) a tool for placing said flexible sewing cuff in the patient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit,(4) means for releasably mounting said flexible sewing cuff to said tool, and(5) a fastener handling means on said housing and operationally connected to said operating handle to be controlled by said operating handle for storing said fastener and securing said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 4. The combination defined in claim 3 wherein each fastener of the tool includes a tissue-penetrating portion and anchoring means on said tissue-penetrating portion for anchoring said tissue-penetrating portion after the tissue-penetrating portion has passed through the patient's tissue. 5. The combination defined in claim 4 wherein the tissue-penetrating portion includes two legs and the anchoring means includes a spring base which is biased to force the legs of the tissue-penetrating. portion into a position in which the legs overlap each other. 6. The combination defined in claim 3 wherein the fastener of the tool includes a helical portion. 7. The combination defined in claim 3 wherein each fastener of the tool includes a tissue-penetrating portion which includes anti-backup barbs. 8. The combination defined in claim 3 wherein said fastener handling means includes of the tool means for storing fasteners and means for opening fasteners. 9. The combination defined in claim 3 wherein said fastener handling means includes of the tool means for storing fasteners and means for imparting rotation to said fasteners. 10. The combination defined in claim 3 wherein said fastener handling means of the tool includes means for storing fasteners and means for advancing fasteners one at a time. 11. The combination defined in claim 1 further including means for operating said operating handle which includes a housing; a handle pivotally mounted on said handle; means for translating pivoting movement of said handle into rotational motion; and means for connecting the translating means to a fastener. 12. In combination: A) a heart valve prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve body separate from said flexible sewing cuff, and(3) means for securely attaching said valve body to said flexible sewing cuff after said flexible swing cuff has been placed in a patient; andB) a tool for placing said flexible sewing cuff in the patient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit,(4) means for releasably mounting said flexible sewing cuff to said tool, and(5) a fastener handling means on said housing and operationally connected to said operating handle to be controlled by said operating handle for storing said fastener and securing said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 13. In combination: A) a multipart heart valve prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis heart valve body separate from said flexible sewing cuff,(3) means for attaching said heart valve body to said flexible sewing cuff after said flexible sewing cuff has been placed in a patient; andB) a tool for placing said flexible sewing cuff in the patient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit,(4) means for releasably mounting said flexible sewing cuff to said tool, and(5) a fastener handling means on said housing and operationally connected to said operating handle to be controlled by said operating handle for storing said fastener and securing said fastener through said flexible sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 14. In combination: A) a heart valve prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate from said flexible sewing cuff, and(3) means for securely attaching said valve to said flexible sewing cuff after said flexible swing cuff has been placed in a patient; andB) a tool for placing said flexible sewing cuff in the patient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit, and(4) a fastener handling means on said housing and operationally connected to said operating handle to be controlled by said operating handle for storing said fastener and securing said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 15. In combination: A) a heart valve prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) means for securely attaching said valve to said flexible sewing cuff after said flexible swing cuff has been placed in a patient; andB) a tool for placing said flexible sewing cuff in the patient in a minimally invasive manner and which includes (1) a housing,(2) an operating handle mounted on said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit, and(4) a fastener handling means on said housing and operationally connected to said operating handle to be controlled by said operating handle for storing said fastener and securing said fastener through said flexible sewing cuff and into the patient's tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 16. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements for securely attaching said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; andB) a tool for attaching said flexible sewing cuff to the patient and which includes (1) a housing,(2) at least one fastener stored in said housing in a tissue-penetrating shape and having an elastic limit, and(3) a fastener handling means on said tool for forcing said fastener into the patient from one side of said flexible sewing cuff and the patient's tissue to attach said flexible sewing cuff to the patient and deforming said fastener beyond its elastic limit into a cuff-retaining shape. 17. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements for securely attaching said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; andB) a tool for attaching said flexible sewing cuff to the patient and which includes (1) a housing,(2) at least one fastener stored in said housing, said fastener being self-tapping to penetrate the patient's tissue when rotated,(3) a fastener handling means on said tool for imparting rotation to said fastener and forcing said fastener into the patient's tissue from one side of the patient's tissue to attach said flexible sewing cuff to the patient. 18. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements for securely attaching said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; andB) a tool for attaching said flexible sewing cuff to the patient and which includes (1) a housing,(2) at least one fastener stored in said housing, and(3) a fastener handling means on said tool for forcing said fastener into the patient from one side of the patient's tissue and attaching said flexible sewing cuff to the patient. 19. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements for securely attaching said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient;B) a fastener for attaching said sewing cuff to the patient from one side of said sewing cuff, said fastener having an elastic limit; andC) means for forcing said fastener through said sewing cuff and attaching said sewing cuff to the patient without exceeding the elastic limit of said fastener whereby said fastener is non-formed when said sewing cuff is attached to the patient by said fastener. 20. In combination: A) a multipart heart valve prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis heart valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements for securely attaching said prosthesis heart valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient;B) a fastener for attaching said sewing cuff to the patient from one side of said sewing cuff, said fastener having an elastic limit and an initial shape; andC) means for forcing said fastener through said sewing cuff and attaching said sewing cuff to the patient without exceeding the elastic limit of said fastener. 21. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) prosthesis valve separate and spaceable from said flexible sewing cuff, said prosthesis valve being attachable to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient, andB) a tool operative to attach said flexible sewing cuff to the patient in a minimally invasive manner, the tool including (1) a housing,(2) an operating member mounted on one end of said housing,(3) at least one fastener carried by said housing, said fastener having an elastic limit,(4) mounting structure on said tool operative to releasably carry said flexible sewing cuff, and(5) a fastener carrier on said housing, said fastener carrier being operatively connected to said operating member such that actuation of said operating member secures said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 22. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate from said flexible sewing cuff and attachable to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient, andB) a tool operative to attach said flexible sewing cuff in the patient in a minimally invasive manner, the tool including (1) a housing,(2) an operating member mounted on said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit,(4) mounting structure on said tool operative to releasably carry said flexible sewing cuff, and(5) a fastener carrier on said housing, said fastener carrier being operatively connected to said operating member such that actuation of said operating member secures said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 23. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements configured to attach said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; andB) a tool operative to attach said flexible sewing cuff to the patient, said tool including (1) a housing,(2) at least one fastener carried by said housing, said fastener having a tissue-penetrating shape and an elastic limit, and(3) a fastener handling device on said tool operating to force said fastener into the patient from one side of said flexible sewing cuff and the patient's tissue to attach said flexible sewing cuff to the patient and thereby deform said fastener beyond its elastic limit into a cuff-retaining shape. 24. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements configured to attach said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; andB) a tool operative to attach said flexible sewing cuff to the patient, said tool including (1) a housing,(2) at least one fastener carried by said housing, said fastener being self-tapping to penetrate the patient's tissue when rotated,(3) a fastener handling device on said tool operative to impart rotation to said fastener and thereby force said fastener into the patient's tissue from one side of the patient's tissue to attach said flexible sewing cuff to the patient. 25. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements configured to attach said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; andB) a tool operative to attach said flexible sewing cuff to the patient, said tool including (1) a housing,(2) at least one fastener carried by said housing, and(3) a fastener handling device on said tool operative to force said fastener into the patient from one side of the patient's tissue and thereby attach said flexible sewing cuff to the patient. 26. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements configured to attach said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient;B) a fastener for attaching said sewing cuff to the patient from one side of said sewing cuff, said fastener having an elastic limit; andC) a tool operative to force said fastener through said sewing cuff and thereby attach said sewing cuff to the patient without exceeding the elastic limit of said fastener, whereby said fastener is nonformed when said sewing cuff is attached to the patient by said fastener. 27. In combination: A) a multipart heart valve prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis heart valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements configured to attach said prosthesis valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient;B) a fastener configured to attach said sewing cuff to the patient from one side of said sewing cuff, said fastener having an elastic limit and an initial shape; andC) a tool operative to force said fastener through said sewing cuff thereby attach said sewing cuff to the patient without exceeding the elastic limit of said fastener and while retaining the initial shape of said fastener. 28. A tool for delivering a fastener into a patient's tissue during a surgical procedure, comprising: (1) a housing,(2) an operating member mounted on one end of the housing,(3) at least one fastener carried by the housing, the fastener having an elastic limit and an initial shape,(4) a fastener carrier disposed in the housing, the fastener carrier being operatively connected to the operating member such that actuation of the operating member secures the fastener into the patient's tissue without deforming the fastener beyond its elastic limit, and(5) a tool element configured for separating the legs of the fastener apart such that the legs regain the initial shape when the tool is withdrawn after the fastener is forced through the patient's tissue,wherein the fastener comprises two legs that overlap each other in the initial shape, andwherein the tool element comprises two extender pins configured to hold the legs of each fastener apart, the two extender pins configured to be immobile with respect to each other. 29. The tool of claim 28, wherein the tool element comprises a fastener track for storing a plurality of fasteners therein, the tool element further comprising an advancing mechanism for moving fasteners down the track until the fasteners drop off the track. 30. A tool for delivering a fastener through a prosthesis into a patient's tissue during a surgical procedure, comprising: a housing,an operating member on one end of the housing,at least one fastener carried by the housing, the fastener comprising an elastic limit and two legs that overlap each other in an overlapping orientation, anda fastener carrier disposed in the housing comprising a tool element, the fastener carrier operatively connected to the operating member such that actuation of the operating member causes the tool element to separate the legs of the fastener apart from the overlapping orientation without deforming the fastener beyond its elastic limit such that the legs move toward the overlapping orientation after the fastener is forced into the patient's tissue and the tool is withdrawn,wherein the tool element comprises two extender pins configured to hold the legs of each fastener apart, the two extender pins configured to be immobile with respect to each other. 31. The tool of claim 30, wherein the tool element comprises a fastener track for storing a plurality of fasteners therein, the tool element further comprising an advancing mechanism for moving fasteners down the track until the fasteners drop off the track. 32. The tool of claim 30, further comprising mounting structure operative to releasable carry a flexible sewing cuff. 33. A system for performing a surgical procedure within a patient's heart, comprising: a prosthesis for implantation within a patient's heart; anda tool comprising a housing, an operating handle on the housing, at least one fastener carried by the housing, the fastener comprising an elastic limit and two legs that overlap each other in an overlapping orientation, and a fastener carrier disposed in the housing comprising a tool element, the fastener carrier operatively connected to the operating handle such that actuation of the operating handle causes the tool element to separate the legs of the fastener apart from the overlapping orientation without deforming the fastener beyond its elastic limit such that the legs move toward the overlapping orientation after the fastener is forced through the prosthesis into a patient's tissue,wherein the tool element comprises two extender pins configured to hold the legs of each fastener apart, the two extender pins configured to be immobile with respect to each other. 34. The system of claim 33, wherein the tool element comprises a fastener track for storing a plurality of fasteners therein, the tool element further comprising an advancing mechanism for moving fasteners down the track until the fasteners drop off the track. 35. The system of claim 33, wherein the tool further comprises mounting structure operative to releasably carry the prosthesis. 36. The system of claim 33, wherein the prosthesis comprises an annuloplasty ring. 37. The system of claim 33, wherein the prosthesis comprises a flexible sewing cuff. 38. The system of claim 33, wherein the prosthesis comprises a valve prosthesis. 39. The system of claim 33, wherein the prosthesis comprises a graft. 40. The system of claim 33, wherein the prosthesis comprises a cardiovascular graft. 41. A system for implanting a prosthesis within a patient's body, comprising: a prosthesis for implantation within a patient's body; anda tool carrying one or more fasteners, each fastener having an elastic limit, an initial shape, and two legs that overlap in the initial shape, the tool configured for holding the legs of each fastener apart, and forcing the legs through the prosthesis into tissue to attach the prosthesis to the patient without exceeding the elastic limit of each fastener,wherein the tool comprises a tool element configured for spreading the legs of the fastener apart such that the legs regain the initial shape when the tool is withdrawn after the fastener is forced through the prosthesis, andwherein the tool element comprises two extender pins configured to hold the legs of each fastener apart, the two extender pins configured to be immobile with respect to each other. 42. The system of claim 41, wherein the tool element comprises a fastener track for storing a plurality of fasteners therein in the initial shape, the tool element further comprising an advancing mechanism for moving fasteners down the track until the fasteners drop off the track. 43. The system of claim 41, wherein the tool element comprises a cover on the fastener track over the fasteners. 44. The system of claim 41, wherein the prosthesis comprises a sewing cuff for a heart valve prosthesis. 45. The system of claim 41, wherein the prosthesis comprises an annuloplasty ring. 46. The system of claim 41, wherein the prosthesis comprises a valve prosthesis. 47. The system of claim 41, wherein the prosthesis comprises a graft. 48. The system of claim 41, wherein the prosthesis comprises a cardiovascular graft. 49. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate from said flexible sewing cuff and attachable to said flexible sewing cuff via an anchor element configured to be actuated by a drawstring extension after said flexible sewing cuff has been attached to a patient, andB) a tool operative to attach said flexible sewing cuff in the patient in a minimally invasive manner, the tool including (1) a housing,(2) an operating member mounted on said housing,(3) at least one fastener stored in said housing, said fastener having an elastic limit,(4) mounting structure on said tool operative to releasable carry said flexible sewing cuff, and(5) a fastener carrier disposed in said housing, said fastener carrier being operatively connected to said operating member such that actuation of said operating member secures said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit. 50. In combination: A) a multipart heart valve prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis heart valve separate and spaceable from said flexible sewing cuff, and(3) anchor elements for securely attaching said prosthesis heart valve to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient, wherein said anchor elements are configured to be actuated by a drawstring extension;B) a fastener for attaching said sewing cuff to the patient from one side of said sewing cuff, said fastener having an elastic limit and an initial shape; andC) means for forcing said fastener through said sewing cuff and attaching said sewing cuff to the patient without exceeding the elastic limit of said fastener. 51. The combination of claim 50, wherein the anchor elements comprise a drawstring configured to attach said prosthesis heart valve to said flexible sewing cuff by being pulled into a recess in said prosthesis heart valve, in response to actuation by the drawstring extension. 52. In combination: A) a multipart prosthesis which includes (1) a flexible sewing cuff,(2) a prosthesis valve separate and spaceable from said flexible sewing cuff, said prosthesis valve being attachable to said flexible sewing cuff via an anchor element configured to be actuated by a drawstring extension after said flexible sewing cuff has been attached to a patient, andB) a tool operative to attach said flexible sewing cuff to the patient in a minimally invasive manner, the tool including (1) a housing,(2) an operating member mounted on one end of said housing,(3) at least one fastener carried by said housing, said fastener having an elastic limit,(4) mounting structure on said tool operative to releasably carry said flexible sewing cuff, and(5) a fastener carrier disposed in said housing, said fastener carrier being operatively connected to said operating member such that actuation of said operating member secures said fastener through said flexible sewing cuff and into the patient's tissue from one side of said sewing cuff and the tissue to attach said flexible sewing cuff to the patient without deforming said fastener beyond its elastic limit.