Means and method of replacing a heart valve in a minimally invasive manner

• US 6,042,607 A
• Filed: 02/21/1997
• Issued: 03/28/2000
• Est. Priority Date: 02/23/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Cardiovascular Technologies, LLC
• Inventors: DiNovo, Dominic P., Keller, George A., Robinson, Cecil R., VanHoose, E. Dale, Ward, Thomas J., Spence, Paul A., Christakis, George T., Williamson, Warren IV
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/802,948
• Time in Patent Office: 1,131 Days
• Field of Search: 623/2, 623/11, 606/149, 606/150, 606/151, 606/153
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/395 with marking agent for marking skin or other tissue
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

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, two at a time to attach the cuff to the tissue from the inside out. The tool stores a plurality of fasteners. Drawstrings are operated from outside the patient'"'"'s body and cinch the sewing cuff to 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. At least two rows of staggered fasteners are 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.

Claims

1. A tool for placing a prosthesis in a patient in a minimally invasive manner comprising:

A) a housing;

B) an operating shaft associated with said housing and extending out of a patient'"'"'s body during use;

C) an operating handle mounted on a proximal end of said operating shaft;

D) a means associated with said housing for delivering and forming at least one fastener to attach a sewing cuff of a prosthesis valve to a patient and including

(1) an anvil located in position to engage and close a fastener when that fastener has been forced against said anvil, and

(2) a driver element in position to engage a fastener and force that fastener against said anvil for closing the fastener; and

E) means for releasably mounting the sewing cuff on said housing during operation of said means for delivering and forming at least one fastener.

20. The tool defined in claim 1 further including a plurality of means for operating said fastener handling means.

21. The tool defined in claim 20 further including a plurality of anvils on said mechanism.

22. The tool defined in claim 21 further including a plurality of driver elements on said mechanism.

23. The tool defined in claim 21 wherein said plurality of anvils are in staggered relationship with each other.

24. The tool defined in claim 1 further including means for controlling the position of a fastener on said means for accommodating fasteners.

25. The tool defined in claim 1 wherein said fastener is W-shaped.

26. The tool defined in claim 1 further including means for ejecting a fastener from said fastener handling means.

27. The tool defined in claim 1 further including means for storing a plurality of fasteners in said fastener handling means.

28. The tool defined in claim 27 wherein said fasteners are located in a plurality of rows.

29. The tool defined in claim 1 wherein said means on another end of said operating shaft for operating said fastener handling means includes a cam.

30. The tool defined in claim 1 wherein said fastener handling means further includes a linkage means for linking said means on another end of said operating shaft for operating said fastener handling means and said operating knob.

31. The tool defined in claim 1 wherein said operating shaft is flexible.

32. The tool defined in claim 1 further including an indexing means for controlling location of said means for storing, delivering and forming a fastener.

33. The tool defined in claim 29 further including a plurality.

34. The tool defined in claim 28 wherein the fasteners in one row are staggered with respect to the fasteners in an adjacent row.

35. The tool defined in claim 1 further including means for releasably mounting a prosthetic valve body on the tool.

36. The tool defined in claim 1 wherein said means on said housing for forcing the sewing cuff against the patient'"'"'s tissue as said fastener handling means is operated includes a biasing element.

37. The tool defined in claim 1 wherein said anvil is located to close a fastener after that fastener has penetrated the sewing cuff and the patient'"'"'s tissue.

38. The tool defined in claim 28 wherein the fasteners of said plurality of fasteners are angularly spaced apart from each other.

39. The tool defined in claim 1 further including means for rotating said means for storing, delivering and forming a fastener about an axis extending through said operating shaft.

40. The tool defined in claim 1 further including means for rotating said means for accommodating fasteners about an axis extending through said operating shaft.

41. The tool defined in claim 1 further including means for forcing the sewing cuff against the patient'"'"'s tissue as said fastener handling means is operated.

43. The tool defined in claim 1 further including means for rotating said fastener handling means about an axis through said housing.

44. The tool defined in claim 1 further including means for rotating said fastener handling means about an axis through said sewing cuff.

45. The tool defined in claim 25 wherein said fastener includes two legs and a crown connecting said legs together, with said legs being linear and said crown being arcuate.

46. The tool defined in claim 45 further including means for supporting said legs and wherein said crown is located between said anvil and said driver element so that said forcing said crown against said anvil causes said legs to rotate toward each other.

2. A tool for placing a prosthesis in a patient during surgery comprising:

A) a housing;

B) a driver mechanism on said housing for driving and forming a first W-shaped fastener;

C) a means on said housing for loading a second W-shaped fastener in the driver mechanism for driving and forming; and

D) means on said housing for approximating a prosthesis against a patient while said fasteners are driven and formed to attach the prosthesis to the patient.

72. The tool defined in claim 2 wherein the means for placing a prosthesis includes means for indexing the means for placing a prosthesis.

3. A tool for placing a prosthesis in a patient in a minimally invasive manner comprising:

A) a housing;

B) an operating handle connected to said housing;

C) a means associated with said housing and controlled by said operating handle for delivering and forming at least one fastener to attach a prosthesis to a patient and including means for storing a plurality of fasteners, whereby fasteners are accommodated on a tool used to place the prosthesis in the patient, and including a stapler containing a plurality of W-shaped staples;

D) means for releasably supporting a flexible cuff portion of the prosthesis while a fastener is being formed; and

E) means for approximating said flexible sewing cuff against a patient while a fastener is being forced through said flexible sewing cuff and is being formed.

4. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) means for securely attaching said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) an operating handle connected to said housing,

(3) means associated with said housing and controlled by said operating handle for delivering and forming at least one fastener to attach said flexible sewing cuff to the patient and including means for storing a plurality of fasteners which are used for attaching said flexible sewing cuff to the patient whereby fasteners are accommodated on said tool,

(4) means for supporting said flexible sewing cuff while a fastener is being formed, and

(5) means for expanding and approximating said flexible sewing cuff against the patient while a fastener is being forced through said flexible sewing cuff and into the patient'"'"'s tissue and is being formed to attach said flexible sewing cuff to the patient.

42. The combination defined in claim 4 in which said tool system further includes means for separating the tool system from the prosthesis.

47. The combination defined in claim 4 wherein said fastener delivery and forming means further includes a plurality of fastener delivery locations.

48. The combination defined in claim 47 wherein said fastener delivery locations are arcuately spaced apart from each other.

49. The combination defined in claim 48 further including additional fastener delivery locations which are spaced apart from the first mentioned fastener delivery locations longitudinally of said fastener delivery mechanism.

50. The combination defined in claim 48 further including a pre-fire rod means for extending tips of the fasteners through the prosthesis into the patient'"'"'s tissue prior to forming the fasteners.

51. The combination defined in claim 47 further including a plurality of wedge cam means for forming fasteners.

52. The combination defined in claim 48 further including means for returning said fastener delivery means to an initial position.

53. The combination defined in claim 48 wherein said fastener delivery means includes a wedge cam alignment block.

54. The combination defined in claim 53 wherein said wedge cam alignment block includes a plurality of slots.

55. The combination defined in claim 48 further including indexing means on said means for supporting said flexible cuff.

56. The combination defined in claim 4 wherein said fastener delivery means includes expander arms.

57. The combination defined in claim 56 wherein said expander arms include expander shoes thereon.

58. The combination defined in claim 57 wherein said expander arms further include ratchet engagement means for maintaining expansion force exerted by said expander arms on the prosthesis.

59. The combination defined in claim 56 further including a means for indexing the means for storing, delivering and forming a fastener between positions.

60. The combination defined in claim 59 further including an index transmission means for connecting an index input element to an index output element.

61. The combination defined in claim 60 wherein said output element includes an increment means for moving said means for storing, delivering and forming a fastener relative to the prosthesis in response to movement of said said input element.

62. The combination defined in claim 56 further including means for releasing the prosthesis from the tool.

63. The combination defined in claim 56 further including a guide tube on the tool.

64. The combination defined in claim 4 wherein said means associated with said housing further includes a stapler containing a plurality of W-shaped staples.

65. The combination defined in claim 56 wherein said fastener handling means includes means for moving it in a helical path with respect to the prosthesis.

66. The combination defined in claim 56 wherein said means associated with said housing includes means for moving it in a single continuous curvilinear path with respect to the flexible sewing cuff of said prosthesis.

67. The combination defined in claim 4 further including staple-pattern defining icons on the prosthesis.

68. The combination defined in claim 4 further including means for delivering staples at an acute angle with respect to the longitudinal centerline of said fastener handling means.

69. The combination defined in claim 4 further including flexible arms on said means for approximating said flexible sewing cuff against the patient.

70. The combination defined in claim 61 further including means for signalling a user when said index gear has moved through a predetermined angle.

73. The combination defined in claim 4 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient.

89. The combination defined in claim 4 wherein said means for expanding and approximating said flexible sewing cuff extends radially outward from said housing.

5. In combination:

A) a multiple part prosthesis which includes

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) means for securely attaching said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) an operating handle,

(3) means associated with said housing and controlled by said operating handle for delivering and forming a fastener to attach one part of said multiple part prosthesis to the patient,

(4) means for storing fasteners on said tool,

(5) means for releasably supporting said flexible sewing cuff while the fastener is being formed, and

(6) means for expanding and approximating said flexible sewing cuff against the patient while the fastener is being formed.

71. The combination defined in claim 5 tool wherein said multipart prosthesis includes a valve.

74. The combination defined in claim 5 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient.

90. The combination defined in claim 5 wherein said means for expanding and approximating said flexible sewing cuff extends radially outward from said housing.

6. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) means for securely attaching said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) an operating shaft,

(3) a mechanism on said housing for delivering and forming a fastener and including means for storing a plurality of fasteners during operation of said fastener delivery and forming mechanism to attach said prosthesis to a patient,

(4) means on said housing and connected to said operating shaft for actuating said fastener delivery and forming mechanism,

(5) means for releasably supporting said flexible sewing cuff of said prosthesis while fasteners are being formed, and

(6) means for expanding and releasably approximating said flexible sewing cuff against the patient while fasteners are being penetrated through said flexible sewing cuff of the prosthesis and are being formed to attach said flexible sewing cuff to the patient.

75. The combination defined in claim 6 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient.

91. The combination defined in claim 6 wherein said means for expanding and approximating said flexible sewing cuff extends radially outward from said housing.

7. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) means for securely attaching said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) a plurality of tissue penetrating fasteners stored in said housing,

(3) an operating shaft,

(4) a fastener delivery and forming mechanism on said housing for delivering and forming a tissue-penetrating fastener and including means for storing tissue-penetrating fasteners during operation of said fastener delivery and forming mechanism to attach the flexible sewing cuff to the patient,

(5) means on said housing and connected to said operating shaft for actuating said fastener delivery and forming mechanism,

(6) means for releasably supporting said flexible sewing cuff of the prosthesis while fasteners are being formed, and

(7) means for expanding and releasably approximating said flexible sewing cuff of the prosthesis against a patient while fasteners are being formed.

76. The combination defined in claim 7 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient.

92. The combination defined in claim 7 wherein said means for expanding and approximating said flexible sewing cuff extends radially outward from said housing.

8. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) means for securely attaching said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) an operating handle connected to said housing,

(3) a means associated with said housing and controlled by said operating handle for delivering and forming at least one fastener to attach said flexible sewing cuff to the patient and including means for storing a plurality of fasteners, whereby fasteners are accommodated on the tool used to place the flexible sewing cuff in the patient,

(4) means for releasably supporting said flexible sewing cuff of said prosthesis while a fastener is being formed,

(5) means for expanding and approximating said flexible sewing cuff against the patient while a fastener is being forced through a portion of said flexible sewing cuff and is being formed; and

(6) means on said means for delivering and forming at least one fastener for releasably holding the portion of said flexible sewing cuff against the patient.

77. The combination defined in claim 8 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient.

93. The combination defined in claim 8 wherein said means for expanding and approximating said flexible sewing cuff extends radially outward from said housing.

9. In combination:

A) a multiple part prosthesis including

(1) a prosthesis body, said prosthesis body including a valve,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) means for securely attaching said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) an operating handle,

(3) a means associated with said housing and controlled by said operating handle for delivering and forming a fastener to attach one part of said multiple part prosthesis to the patient whereby fasteners are accommodated on the tool used to place the flexible sewing cuff of the prosthesis in the patient and including means for storing a plurality of fasteners,

(4) means for releasably supporting said flexible sewing cuff while a fastener is being formed, and

(5) means for expanding and approximating said flexible sewing cuff of the multipart prosthesis against the patient while the fastener is being formed.

78. The combination defined in claim 9 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient.

94. The combination defined in claim 9 wherein said means for expanding and approximating said flexible sewing cuff extends radially outward from said housing.

10. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) means for securely attaching said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) an operating handle connected to said housing,

(3) a means associated with said housing and controlled by said operating handle for delivering and forming at least one fastener to attach said flexible sewing cuff of the prosthesis to the patient and including means for storing a plurality of fasteners, whereby fasteners are accommodated on the tool used to place the sewing cuff in the patient, said fastener delivering and forming means including a plurality of arcuately spaced apart fastener delivery locations thereon,

(4) means for releasably supporting said flexible sewing cuff of the prosthesis while a fastener is being formed,

(5) means for expanding and approximating said flexible sewing cuff against the patient while a fastener is being forced through a portion of said flexible sewing cuff and is being formed, and

(6) a pre-fire rod means for extending tips of the fasteners through said flexible sewing cuff into the patient'"'"'s tissue prior to forming the fasteners to attach the flexible sewing cuff of the prosthesis to the patient.

79. The combination defined in claim 10 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient.

95. The combination defined in claim 10 wherein said means for expanding and approximating said flexible sewing cuff extends radially outward from said housing.

11. In combination:

A) a prosthesis which includes a sewing cuff which is flexible, expandable and deformable to fit the size and shape of a patient'"'"'s tissue during installation of said flexible sewing cuff in the patient; and

B) a tool system for placing said prosthesis in the patient in a minimally invasive manner including

(1) a housing,

(2) an operating handle connected to said housing,

(3) a means associated with said housing and controlled by said operating handle for delivering and forming at least one fastener to attach a prosthesis to a patient and including means for storing a plurality of fasteners, whereby fasteners are accommodated on the tool used to place the flexible sewing cuff in the patient,

(4) means for releasably supporting said flexible sewing cuff of said prosthesis while a fastener is being formed, and

(5) expander arms for approximating a portion of said sewing cuff against the patient while a fastener is being forced through said flexible sewing cuff and is being formed.

80. The combination defined in claim 11 wherein said means for securely attaching the prosthesis body to said flexible sewing cuff includes extensions that extend outside the patient, patient.

96. The combination defined in claim 11 wherein said expander arms extend radially outward from said housing.

12. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) drawstrings which securely attach said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system including

(1) a housing,

(2) an operating handle connected to said housing,

(3) a driver and anvil associated with said housing and controlled by said operating handle which deliver and form at least one fastener to attach said flexible sewing cuff to the patient and including a storage pocket which stores a plurality of fasteners which are used for attaching said flexible sewing cuff to the patient whereby fasteners are accommodated on said tool,

(4) an anchor which supports said flexible sewing cuff while a fastener is being formed, and

(5) expander arms positioned to engage the inside of said flexible sewing cuff and urge said flexible sewing cuff against the patient'"'"'s tissue while a fastener is being forced through said flexible sewing cuff and into the patient'"'"'s tissue and is being formed to attach said flexible sewing cuff to the patient.

81. The combination defined in claim 12 in which said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

97. The combination defined in claim 12 wherein said expander arms extend radially outward from said housing.

13. In combination:

A) a multiple part prosthesis which includes

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) drawstrings which securely attach said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system including

(1) a housing,

(2) an operating handle,

(3) an anvil and driver associated with said housing and controlled by said operating handle and which deliver and form a fastener to attach one part of said multiple part prosthesis to the patient,

(4) a storage pocket which stores fasteners on said tool,

(5) an anchor which releasably supports said flexible sewing cuff while the fastener is being formed, and

(6) expander arms which expand and approximate said flexible sewing cuff against the patient while the fastener is being formed.

82. The combination defined in claim 13 in which said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

98. The combination defined in claim 13 wherein said expander arms extend radially outward from said housing.

14. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) drawstrings which securely attach said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system including

(1) a housing,

(2) an operating shaft,

(3) a driver and anvil on said housing which delivers and forms a fastener and including a storage pocket in which a plurality of fasteners are stored during operation of said driver and anvil and which attaches said flexible sewing cuff of said prosthesis to the patient,

(4) an anchor which releasably supports said flexible sewing cuff of said prosthesis while fasteners are being formed, and

(5) engaging arms which engage said flexible sewing cuff and expand and approximate said flexible sewing cuff against the patient while fasteners are being penetrated through said flexible sewing cuff of the prosthesis and are being formed to attach said flexible sewing cuff to the patient.

83. The combination defined in claim 14 in which said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

99. The combination defined in claim 14 wherein said engaging arms extend radially outward from said housing.

15. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) drawstrings which securely attach said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system including

(1) a housing,

(2) a plurality of tissue penetrating fasteners stored in said housing,

(3) an operating shaft,

(4) an anvil and driver on said housing which deliver and form a tissue-penetrating fastener and including a storage pocket in which is stored tissue-penetrating fasteners during operation of said anvil and driver to attach said sewing cuff to the patient,

(5) anchors which releasably support said flexible sewing cuff of the prosthesis while fasteners are being formed, and

(6) engaging arms which expand and approximate said flexible sewing cuff of the prosthesis against a patient while fasteners are being formed.

84. The combination defined in claim 15 in which said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

100. The combination defined in claim 15 wherein said engaging arms extend radially outward from said housing.

16. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) drawstrings which securely attach said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system including

(1) a housing,

(2) an operating handle connected to said housing,

(3) an anvil and driver associated with said housing and controlled by said operating handle which deliver and form at least one fastener to attach said flexible sewing cuff of said prosthesis to the patient and including a pocket in which a plurality of fasteners are stored, whereby fasteners are accommodated on the tool used to place the flexible sewing cuff in the patient,

(4) anchors which releasably supports said flexible sewing cuff of said prosthesis while the fastener is being formed, and

(5) engaging arms which expand and approximate the flexible sewing cuff against the patient while a fastener is being forced through a portion of said flexible sewing cuff and is being formed.

85. The combination defined in claim 16 in which said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

101. The combination defined in claim 16 wherein said engaging arms extend radially outward from said housing.

17. In combination:

A) a multiple part prosthesis including

(1) a prosthesis body, said prosthesis body including a valve,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) drawstrings which securely attach said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system including

(1) a housing,

(2) an operating handle,

(3) an anvil and driver associated with said housing and controlled by said operating handle and which deliver and form a fastener to attach one part of said multiple part prosthesis to the patient whereby fasteners are accommodated on the tool used to place the flexible sewing cuff of the prosthesis in the patient and including a pocket in which a plurality of fasteners are stored,

(4) an anchor which releasably supports said flexible sewing cuff while a fastener is being formed, and

(5) engaging arms which expand and approximate said flexible sewing cuff of the multipart prosthesis against the patient while the fastener is being formed.

86. The combination defined in claim 17 in which said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

102. The combination defined in claim 17 wherein said engaging arms extend radially outward from said housing.

18. In combination:

A) a prosthesis including

(1) a prosthesis body,

(2) an expandable flexible sewing cuff separate and spaceable from said prosthesis body, and

(3) drawstrings which securely attach said prosthesis body to said flexible sewing cuff after said flexible sewing cuff has been attached to a patient; and

B) a tool system including

(1) housing,

(2) an operating handle connected to said housing,

(3) a an anvil and driver associated with said housing and controlled by said operating handle and which deliver and form at least one fastener to attach said flexible sewing cuff of the prosthesis to the patient and including a pocket in which a plurality of fasteners are stored whereby fasteners are accommodated on the tool used to place the sewing cuff in the patient, said anvil and driver including a plurality of arcuately spaced apart fastener delivery locations thereon,

(4) an anchor which releasably supports said flexible sewing cuff of the prosthesis while a fastener is being formed,

(5) engaging arms which approximate said flexible sewing cuff against the patient while the fastener is being forced through a portion of said flexible sewing cuff and is being formed, and

(6) a pre-fire rod which extends tips of the fasteners through said flexible sewing cuff into the patient'"'"'s tissue prior to forming the fasteners to attach the flexible sewing cuff of the prosthesis to the patient.

87. The combination defined in claim 18 in which said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

103. The combination defined in claim 18 wherein said engaging arms extend radially outward from said housing.

19. In combination:

A) a prosthesis which includes a sewing cuff which is flexible and deformable to fit the size and shape of a patient'"'"'s tissue during installation of said flexible sewing cuff in the patient; and

B) a tool system including

(1) a housing,

(2) an operating handle connected to said housing,

(3) an anvil and driver associated with said housing and controlled by said operating handle and which delivers and forms at least one fastener to attach said flexible sewing cuff to the patient and including a pocket in which a plurality of fasteners are stored, whereby fasteners are accommodated on the tool used to place the flexible sewing cuff in the patient,

(4) an anchor which releasably supports said flexible sewing cuff of said prosthesis while a fastener is being formed, and

(5) expander arms which approximate a portion of said flexible sewing cuff against the patient while a fastener is being forced through said flexible sewing cuff and is being formed.

88. The combination defined in claim 19 in which said prosthesis further includes a prosthesis body and drawstrings which connect said body to said flexible sewing cuff, wherein said drawstrings include extensions that extends out of the patient during installation of said flexible sewing cuff in the patient.

104. The combination defined in claim 19 wherein said expander arms extend radially outward from said housing.