Endovascular aortic valve replacement

Claim 2

1 - 4 . (Cancelled)

Claim 3

5 . A valve introducer device for inserting a prosthetic valve device at a vascular, or cardiac situs which when inserted in the lumen of a blood vessel in the presence of blood flow comprises: a layer, a tube, a pusher devise and a bracer, wherein:, i) said layer, the introducer capsule, comprising a tubular flexible substrate means having a′ generally cylindrical outside surface and a generally cylindrical inside surface and reinforced at the proximal end which is open, and having a semi-closed distal end with a perforate opening having a diameter approximately the same as the internal diameter of the tube, characterized as capable of transporting said prosthetic valve device to said situs, ii) said tube, the introducer channel, comprising an elongated tubular durable flexible substrate means' having a generally cylindrical outside surface and a generally cylindrical inside surface which proximal open end is attached at said situs of the distal opening of said introducer capsule and which distal end extends out the external entry of said blood vessel, and is characterized as containing a pusher channel of a pusher device within its lumen, iii) said pusher device comprising a disc and a tube, said disc of said pusher device comprising a generally circular disc, with a generally flat distal surface, a generally flat proximal surface and a central opening, and made of a durable, flexible material, having its proximal surface abut said prosthetic valve device contained within said introducer capsule, and attached at said central opening of its distal surface is said proximal end of said tube, which comprises: an elongated flexible cylinder made of durable, flexible, non-thrombogenic material, having a generally cylindrical outside surface and a generally cylindrical inside surface and a smaller internal diameter than that used in said introducer channel, and is characterized as capable of maintaining its structural integrity such that it does not distort upon the application of external pressure, of being contained within the lumen of said introducer channel with its distal end extending beyond the vascular entry point via said introducer channel, of allowing passage of a mounting balloon and guide wire, and of advancing within the lumen of said introducer channel, upon application of external pressure to advance said pusher disc, and thereby said prosthetic valve device within said introducer capsule, and iv) said bracer, comprising a differentially expandable device circumferentially attached to the external surface of said introducer capsule at said capsule's proximal end and is characterized as having the capability of expanding to hold said introducer capsule in a precise position during delivery of said prosthetic valve device.

Claim 4

5 . A valve introducer device for inserting a prosthetic valve device at a vascular, or cardiac situs which when inserted in the lumen of a blood vessel in the presence of blood flow comprises: a layer, a tube, a pusher devise and a bracer, wherein:, i) said layer, the introducer capsule, comprising a tubular flexible substrate means having a′ generally cylindrical outside surface and a generally cylindrical inside surface and reinforced at the proximal end which is open, and having a semi-closed distal end with a perforate opening having a diameter approximately the same as the internal diameter of the tube, characterized as capable of transporting said prosthetic valve device to said situs, ii) said tube, the introducer channel, comprising an elongated tubular durable flexible substrate means' having a generally cylindrical outside surface and a generally cylindrical inside surface which proximal open end is attached at said situs of the distal opening of said introducer capsule and which distal end extends out the external entry of said blood vessel, and is characterized as containing a pusher channel of a pusher device within its lumen, iii) said pusher device comprising a disc and a tube, said disc of said pusher device comprising a generally circular disc, with a generally flat distal surface, a generally flat proximal surface and a central opening, and made of a durable, flexible material, having its proximal surface abut said prosthetic valve device contained within said introducer capsule, and attached at said central opening of its distal surface is said proximal end of said tube, which comprises: an elongated flexible cylinder made of durable, flexible, non-thrombogenic material, having a generally cylindrical outside surface and a generally cylindrical inside surface and a smaller internal diameter than that used in said introducer channel, and is characterized as capable of maintaining its structural integrity such that it does not distort upon the application of external pressure, of being contained within the lumen of said introducer channel with its distal end extending beyond the vascular entry point via said introducer channel, of allowing passage of a mounting balloon and guide wire, and of advancing within the lumen of said introducer channel, upon application of external pressure to advance said pusher disc, and thereby said prosthetic valve device within said introducer capsule, and iv) said bracer, comprising a differentially expandable device circumferentially attached to the external surface of said introducer capsule at said capsule's proximal end and is characterized as having the capability of expanding to hold said introducer capsule in a precise position during delivery of said prosthetic valve device.

Claim 5

6 . A prosthetic valve device for supplanting or replacing a cardiac valve which when inserted in the lumen of a blood vessel, in extra-anatomic conduits or at a cardiac valve annulus situs in the presence of blood flow comprises: a sleeve, a valve and an annulus, wherein i) said sleeve comprises a tubular flexible substrate means having a generally cylindrical outside layer secured to (ii) said compressible annulus at its base comprising a mounting ring by a series of mounting pins, and a generally cylindrical inside surface contacting an inner layer comprising (iii) said valve, characterized as capable of insertion into a cardiac or vascular situs through a host blood vessel, host compatible and capable of autonomous operation, which when inserted in said situs in the presence of blood flow comprises a flexible annulus having a generally cylindrical outside surface and a generally cylindrical inside surface containing at least one cusp to permit blood flow through said cusp in a single direction; (iv) attachment means comprising at said first 5 and second open ends of said cusp to permit fixation of said device at least at″ or above said annulus of said dysfunctional valve by the mounting ring which comprises; v) a flexible annulus having a generally cylindrical inside surface and a generally cylindrical outside surface containing a series of mounting pins to fixate said prosthetic valve device at said situs.

Claim 6

6 . A prosthetic valve device for supplanting or replacing a cardiac valve which when inserted in the lumen of a blood vessel, in extra-anatomic conduits or at a cardiac valve annulus situs in the presence of blood flow comprises: a sleeve, a valve and an annulus, wherein i) said sleeve comprises a tubular flexible substrate means having a generally cylindrical outside layer secured to (ii) said compressible annulus at its base comprising a mounting ring by a series of mounting pins, and a generally cylindrical inside surface contacting an inner layer comprising (iii) said valve, characterized as capable of insertion into a cardiac or vascular situs through a host blood vessel, host compatible and capable of autonomous operation, which when inserted in said situs in the presence of blood flow comprises a flexible annulus having a generally cylindrical outside surface and a generally cylindrical inside surface containing at least one cusp to permit blood flow through said cusp in a single direction; (iv) attachment means comprising at said first 5 and second open ends of said cusp to permit fixation of said device at least at″ or above said annulus of said dysfunctional valve by the mounting ring which comprises; v) a flexible annulus having a generally cylindrical inside surface and a generally cylindrical outside surface containing a series of mounting pins to fixate said prosthetic valve device at said situs.

Claim 7

7 - 11 . (Cancelled)

Claim 8

7 - 11 . (Cancelled)

Claim 9

12 . A method of supplanting a cardiac or other valve or prosthesis endovascularly which method comprises: a valve introducer device containing a prosthetic valve device transports it to a valve fixation situs endovascularly, through surface insertion of and passage through the host's vasculature, to the fixation situs and upon reaching the fixation situs: a valve introducer device's bracer expands to position said valve introducer device correctly for insertion of said prosthetic valve device at said valve situs, a pusher device of said valve introducer device advances to expel a prosthetic valve device from an introducer capsule, upon which a balloon which has been introduced by a guide wire via a pusher channel of said pusher device, is inflated at said situs to securely mount said prosthetic valve device, and upon secure fixation of said prosthetic valve device at said situs: said bracer is contracted, said balloon deflated, and said valve introducer device, said balloon and said guide wire are removed from said host's vasculature.

Claim 10

12 . A method of supplanting a cardiac or other valve or prosthesis endovascularly which method comprises: a valve introducer device containing a prosthetic valve device transports it to a valve fixation situs endovascularly, through surface insertion of and passage through the host's vasculature, to the fixation situs and upon reaching the fixation situs: a valve introducer device's bracer expands to position said valve introducer device correctly for insertion of said prosthetic valve device at said valve situs, a pusher device of said valve introducer device advances to expel a prosthetic valve device from an introducer capsule, upon which a balloon which has been introduced by a guide wire via a pusher channel of said pusher device, is inflated at said situs to securely mount said prosthetic valve device, and upon secure fixation of said prosthetic valve device at said situs: said bracer is contracted, said balloon deflated, and said valve introducer device, said balloon and said guide wire are removed from said host's vasculature.

Claim 11

13 . (Cancelled)

Claim 12

13 . (Cancelled)

Claim 13

14 . A method of emboli free endovascular procedures which method comprises: a procedure device capsule contains and transports an intraluminal procedure device endovascularly, through surface insertion of and passage through a host's vasculature, to a situs for procedure whereby a barrier of said intraluminal procedure device exits from said procedure device capsule, expands in a controlled and adjustable manner, abuts the lumen of said vessel, and encircles said procedure situs, and upon which: a procedure instrument travels through a working channel in said procedure device to said procedure situs and upon arrival at said situs performs its specific task, and any resulting loose matter is trapped by said barrier or is removed from said host's vasculature through suction and other tissue retrieval device inserted via said working channel, and completion of said procedure and removal of all said procedure instruments through said working channel, said barrier is contracted, and said intraluminal procedure device is withdrawn into and secured in said procedure device capsule, which is then removed.

Claim 14

14 . A method of emboli free endovascular procedures which method comprises: a procedure device capsule contains and transports an intraluminal procedure device endovascularly, through surface insertion of and passage through a host's vasculature, to a situs for procedure whereby a barrier of said intraluminal procedure device exits from said procedure device capsule, expands in a controlled and adjustable manner, abuts the lumen of said vessel, and encircles said procedure situs, and upon which: a procedure instrument travels through a working channel in said procedure device to said procedure situs and upon arrival at said situs performs its specific task, and any resulting loose matter is trapped by said barrier or is removed from said host's vasculature through suction and other tissue retrieval device inserted via said working channel, and completion of said procedure and removal of all said procedure instruments through said working channel, said barrier is contracted, and said intraluminal procedure device is withdrawn into and secured in said procedure device capsule, which is then removed.