US6042607A — Means and method of replacing a heart valve in a …

Claim 1

Independent Claim 145 words

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.

Claim 2

Dependent Claim 145 words

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.

Claim 3

Dependent Claim 77 words

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.

Claim 4

Dependent Claim 77 words

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.

Claim 5

Dependent Claim 133 words

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.

Claim 6

Dependent Claim 133 words

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.

Claim 7

Dependent Claim 191 words

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.

Claim 8

Dependent Claim 191 words

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.

Claim 9

Dependent Claim 149 words

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.

Claim 10

Dependent Claim 149 words

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.

Claim 11

Dependent Claim 187 words

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.

Claim 12

Dependent Claim 187 words

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.

Claim 13

Dependent Claim 185 words

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.

Claim 14

Dependent Claim 185 words

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.

Claim 15

Dependent Claim 209 words

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.

Claim 16

Dependent Claim 209 words

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.

Claim 17

Dependent Claim 180 words

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.

Claim 18

Dependent Claim 180 words

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.

Claim 19

Dependent Claim 239 words

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.

Claim 20

Dependent Claim 239 words

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.

Claim 21

Dependent Claim 167 words

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.

Claim 22

Dependent Claim 167 words

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.

Claim 23

Dependent Claim 195 words

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.

Claim 24

Dependent Claim 195 words

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.

Claim 25

Dependent Claim 145 words

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.

Claim 26

Dependent Claim 145 words

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.

Claim 27

Dependent Claim 173 words

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.

Claim 28

Dependent Claim 173 words

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.

Claim 29

Dependent Claim 153 words

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.

Claim 30

Dependent Claim 153 words

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.

Claim 31

Dependent Claim 180 words

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.

Claim 32

Dependent Claim 180 words

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.

Claim 33

Dependent Claim 176 words

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.

Claim 34

Dependent Claim 176 words

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.

Claim 35

Dependent Claim 230 words

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.

Claim 36

Dependent Claim 230 words

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.

Claim 37

Dependent Claim 164 words

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.

Claim 38

Dependent Claim 164 words

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.

Claim 39

Dependent Claim 18 words

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

Claim 40

Dependent Claim 15 words

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

Claim 41

Dependent Claim 16 words

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

Claim 42

Dependent Claim 18 words

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

Claim 43

Dependent Claim 22 words

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

Claim 44

Dependent Claim 11 words

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

Claim 45

Dependent Claim 18 words

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

Claim 46

Dependent Claim 20 words

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

Claim 47

Dependent Claim 16 words

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

Claim 48

Dependent Claim 25 words

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.

Claim 49

Dependent Claim 37 words

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.

Claim 50

Dependent Claim 12 words

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

Claim 51

Dependent Claim 24 words

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

Claim 52

Dependent Claim 10 words

The tool defined in claim 29 further including a plurality.

Claim 53

Dependent Claim 23 words

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

Claim 54

Dependent Claim 19 words

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

Claim 55

Dependent Claim 32 words

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.

Claim 56

Dependent Claim 27 words

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.

Claim 57

Dependent Claim 21 words

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

Claim 58

Dependent Claim 28 words

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.

Claim 59

Dependent Claim 24 words

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

Claim 60

Dependent Claim 25 words

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.

Claim 61

Dependent Claim 22 words

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

Claim 62

Dependent Claim 21 words

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

Claim 63

Dependent Claim 22 words

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

Claim 64

Dependent Claim 29 words

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.

Claim 65

Dependent Claim 43 words

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.

Claim 66

Dependent Claim 21 words

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

Claim 67

Dependent Claim 18 words

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

Claim 68

Dependent Claim 29 words

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.

Claim 69

Dependent Claim 30 words

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.

Claim 70

Dependent Claim 17 words

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

Claim 71

Dependent Claim 19 words

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

Claim 72

Dependent Claim 17 words

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

Claim 73

Dependent Claim 17 words

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

Claim 74

Dependent Claim 18 words

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

Claim 75

Dependent Claim 14 words

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

Claim 76

Dependent Claim 14 words

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

Claim 77

Dependent Claim 27 words

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.

Claim 78

Dependent Claim 23 words

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

Claim 79

Dependent Claim 23 words

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

Claim 80

Dependent Claim 38 words

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.

Claim 81

Dependent Claim 16 words

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

Claim 82

Dependent Claim 14 words

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

Claim 83

Dependent Claim 23 words

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

Claim 84

Dependent Claim 25 words

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.

Claim 85

Dependent Claim 34 words

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.

Claim 86

Dependent Claim 14 words

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

Claim 87

Dependent Claim 27 words

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.

Claim 88

Dependent Claim 22 words

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

Claim 89

Dependent Claim 23 words

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

Claim 90

Dependent Claim 14 words

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

Claim 91

Dependent Claim 23 words

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

Claim 92

Dependent Claim 27 words

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.

Claim 93

Dependent Claim 27 words

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.

Claim 94

Dependent Claim 27 words

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.

Claim 95

Dependent Claim 27 words

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.

Claim 96

Dependent Claim 27 words

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.

Claim 97

Dependent Claim 27 words

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.

Claim 98

Dependent Claim 27 words

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.

Claim 99

Dependent Claim 28 words

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.

Claim 100

Dependent Claim 28 words

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.

Claim 101

Dependent Claim 28 words

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.

Claim 102

Dependent Claim 28 words

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.

Claim 103

Dependent Claim 28 words

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.

Claim 104

Dependent Claim 28 words

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.

Claim 105

Dependent Claim 28 words

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.

Claim 106

Dependent Claim 28 words

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.

Claim 107

Dependent Claim 47 words

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.

Claim 108

Dependent Claim 23 words

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

Claim 109

Dependent Claim 23 words

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

Claim 110

Dependent Claim 23 words

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

Claim 111

Dependent Claim 23 words

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

Claim 112

Dependent Claim 23 words

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

Claim 113

Dependent Claim 23 words

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

Claim 114

Dependent Claim 23 words

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

Claim 115

Dependent Claim 16 words

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

Claim 116

Dependent Claim 16 words

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

Claim 117

Dependent Claim 16 words

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

Claim 118

Dependent Claim 16 words

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

Claim 119

Dependent Claim 16 words

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

Claim 120

Dependent Claim 16 words

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

Claim 121

Dependent Claim 16 words

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

Claim 122

Dependent Claim 16 words

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

Claim 123

Dependent Claim 16 words

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

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2003-03-28	2003-09-27	2004-03-28	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2007-03-28	2007-09-27	2008-03-28	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2011-03-28	2011-09-27	2012-03-28	$7700.00	Window Closed / Lapsed

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

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