System for controlled delivery of stents and grafts

Claim 2

1 . Apparatus for percutaneously delivering a self-expanding prosthesis to a target site within a patient's vascular system comprising: (a) an outer tubular guiding catheter having a proximal end, a distal end and a lumen extending therebetween; (b) an inner tubular pusher catheter having a proximal end, a distal end and lumen extending therebetween, the inner pusher catheter having an outer diameter sized to slidingly fit within the lumen of the guiding catheter; and (c) an elongate, flexible member coaxially insertable through the lumen of the inner pusher catheter, said elongate, flexible member having a proximal end and a distal end, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner pusher catheter at said distal end of the inner pusher catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner pusher catheter.

Claim 3

2 . The apparatus as in claim 1 wherein the elongate member further includes a second bead member affixed thereto at a location a predetermined distance proximal of the first bead member, the second bead member sized to slidingly fit within the lumen of the inner tubular catheter.

Claim 4

3 . The apparatus as in claim 1 wherein the first bead member is one of spherical, oval and frusto-conically shaped.

Claim 5

4 . The apparatus as in claim 3 wherein the first bead member has a friction enhancing surface thereon.

Claim 6

5 . The apparatus as in claim 4 wherein the friction enhancing surface is a knurled surface.

Claim 7

6 . The apparatus as in claim 4 wherein the friction enhancing surface is a polymer.

Claim 8

7 . The apparatus in claim 1 wherein the first bead member is spherical.

Claim 9

8 . The apparatus as in claim 2 wherein the second bead member comprises an annulus.

Claim 10

9 . The apparatus as in claim 1 wherein a proximal end portion of the self-expanding prosthesis is captured between the first bead member and a wall defining the lumen of the inner pusher catheter at the distal end thereof when the tension force is being applied.

Claim 11

10 . The apparatus as in claim 1 wherein the elongate, flexible member comprises a wire.

Claim 12

11 . The apparatus as in claim 1 wherein the elongate, flexible member comprises a cable.

Claim 13

12 . The apparatus as in claim 1 wherein the elongate, flexible member comprises a tube having a lumen extending the length thereof.

Claim 14

13 . The apparatus as in claim 12 and further including a guidewire inserted through the lumen of the elongate, flexible member.

Claim 15

14 . The apparatus as in claim 1 wherein the outer tubular guide catheter includes a first Y adapter having a Luer fitting on the proximal end thereof and the inner pusher catheter includes a second Y adapter with a Luer fitting on the proximal end thereof.

Claim 16

15 . The apparatus as in claim 14 and further including a compression spring disposed in surrounding relation with respect to the elongate, flexible member between the Luer fitting of the second Y adapter and a clamp member releasably affixed to the elongate, flexible member.

Claim 17

16 . The apparatus as in claim 15 wherein the self-expanding prosthesis is released from the distal end of the inner catheter when the first bead member is advanced distally with respect to the inner catheter.

Claim 18

17 . The apparatus as in claim 1 wherein the self-expanding prosthesis comprises a plurality of fine metal wire strands interwoven to form a tubular metal fabric having open proximal and distal ends and where the metal strands at the proximal end of the tubular metal fabric are adapted to be captured between the first bead member and a wall defining the lumen of the inner pusher catheter at the distal end thereof.

Claim 19

18 . The apparatus as in claim 17 wherein the fine wires comprise shape memory alloy wires.

Claim 20

19 . The apparatus as in claim 18 wherein the shape memory alloy is Nitinol.

Claim 21

20 . Apparatus for percutaneously delivering a self-expanding prosthesis to a target site within a patient's vascular system comprising: (a) a tubular inner catheter having a proximal end, a distal end and lumen extending therebetween, the inner catheter having an outer diameter adapted to slidingly fit within the lumen of a guiding catheter; and (b) an elongate, flexible member coaxially insertable through the lumen of the inner tubular catheter, said elongate, flexible member having a proximal end and a distal end, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter.

Claim 22

20 . Apparatus for percutaneously delivering a self-expanding prosthesis to a target site within a patient's vascular system comprising: (a) a tubular inner catheter having a proximal end, a distal end and lumen extending therebetween, the inner catheter having an outer diameter adapted to slidingly fit within the lumen of a guiding catheter; and (b) an elongate, flexible member coaxially insertable through the lumen of the inner tubular catheter, said elongate, flexible member having a proximal end and a distal end, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter.

Claim 23

21 . The apparatus as in claim 20 and further including a compression spring operatively coupled between the proximal end of the inner tubular catheter and a clamp member releasably affixed to the elongate member.

Claim 24

22 . The apparatus as in claim 20 wherein the elongate member further includes a second bead member affixed thereto at a location a predetermined distance proximal of the first bead member, the second bead member sized to slidingly fit within the lumen of the tubular catheter.

Claim 25

23 . The apparatus as in claim 22 and further including a stop member disposed within the lumen of the tubular inner catheter a predetermined distance proximal of a distal end of the tubular inner catheter, the stop member adapted to engage the second bead member as the elongated flexible member is slid in a proximal direction within the lumen of the tubular inner catheter.

Claim 26

24 . The apparatus as in claim 20 wherein the first bead member is frusto-conically shaped.

Claim 27

25 . The apparatus as in claim 20 wherein the first bead member is either spherical or ovaloid.

Claim 28

26 . The apparatus as in claim 20 wherein the first bead member has a friction enhancing surface thereon.

Claim 29

27 . The apparatus as in claim 26 wherein the friction enhancing surface is a knurled surface.

Claim 30

28 . The apparatus as in claim 26 wherein the friction enhancing surface is a polymer.

Claim 31

29 . The apparatus as in claim 22 wherein the second bead member comprises an annulus.

Claim 32

30 . The apparatus as in claim 21 wherein a proximal end portion of the self-expanding prosthesis is captured between the first bead member and a wall defining the lumen of the inner tubular catheter at the distal end thereof when the tension force is being applied.

Claim 33

31 . The apparatus as in claim 20 wherein the elongate, flexible member is a wire.

Claim 34

32 . The apparatus as in claim 20 wherein the elongate, flexible member comprises a cable.

Claim 35

33 . The apparatus as in claim 21 wherein the compression spring is disposed in surrounding relation with respect to the elongate member between a Luer fitting on the tubular inner catheter and the clamp member.

Claim 36

34 . The apparatus as in claim 21 wherein the self-expanding prosthesis is released from the distal end of the inner tubular catheter when the first bead member is advanced distally with respect to the inner catheter.

Claim 37

35 . The apparatus as in claim 20 wherein the self-expanding prosthesis comprises a plurality of fine metal wire strands interwoven to form a tubular metal fabric having open proximal and distal ends and where the metal wire strands at the proximal end of the tubular metal fabric are adapted to be captured between the first bead member and a wall defining the lumen of the inner tubular catheter at the distal end thereof when said tension force is applied.

Claim 38

36 . The apparatus as in claim 35 wherein the fine wires comprise shape memory alloy wires.

Claim 39

37 . The apparatus as in claim 35 wherein the shape memory alloy is Nitinol.

Claim 40

38 . The apparatus as in claim 30 and further including a rigid tubular extension affixed to the distal end of the tubular inner catheter.

Claim 41

39 . The apparatus as in claim 38 wherein the rigid tubular extension includes a threaded surface on an internal diameter thereof and the elongate flexible member includes a cylinder portion having a threaded surface mating with the threaded surface on the tubular extension such that rotation of the elongate, flexible member translates the first bead member in an axial direction.

Claim 42

40 . A method for controllably delivering a braided, self-expanding tubular prosthesis to a selected site in the vascular system comprising the steps of: (a) providing the combination of: (i) a flexible tubular inner catheter having a proximal end, a distal end and a lumen extending therebetween, the inner catheter having an outer diameter adapted to slidingly fit within the lumen of a guiding catheter, (ii) an elongate, flexible member coaxially insertable through the lumen of the inner tubular catheter, said elongate flexible member having a proximal end and a distal end, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter, (iii) a braided tubular prosthesis with the proximal ends of individual strands comprising the prosthesis captured between the first bead member and the distal end of the inner tubular catheter; (b) feeding the inner tubular catheter with the braided tubular prosthesis attached through a lumen of the guiding catheter and out a distal end thereof; (c) moving the elongate flexible member relative to the tubular inner catheter to release the tubular prosthesis from the distal end of the tubular inner catheter.

Claim 43

40 . A method for controllably delivering a braided, self-expanding tubular prosthesis to a selected site in the vascular system comprising the steps of: (a) providing the combination of: (i) a flexible tubular inner catheter having a proximal end, a distal end and a lumen extending therebetween, the inner catheter having an outer diameter adapted to slidingly fit within the lumen of a guiding catheter, (ii) an elongate, flexible member coaxially insertable through the lumen of the inner tubular catheter, said elongate flexible member having a proximal end and a distal end, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter, (iii) a braided tubular prosthesis with the proximal ends of individual strands comprising the prosthesis captured between the first bead member and the distal end of the inner tubular catheter; (b) feeding the inner tubular catheter with the braided tubular prosthesis attached through a lumen of the guiding catheter and out a distal end thereof; (c) moving the elongate flexible member relative to the tubular inner catheter to release the tubular prosthesis from the distal end of the tubular inner catheter.

Claim 44

41 . The method of claim 40 wherein the step of feeding the inner tubular catheter with the braided prosthesis out the distal end of the guiding catheter is achieved either by drawing the guiding catheter proximally while holding the inner tubular catheter and prosthesis fixed or by advancing the inner tubular catheter in the distal direction while holding the guiding catheter fixed.

Claim 45

42 . A method for controllably delivering a braided, self-expanding tubular prosthesis to a selected site in the vascular system comprising the steps of: (a) providing the combination of: i) an outer guiding catheter; ii) A flexible, tubular inner catheter having a proximal end, a distal end and a lumen extending therebetween the inner catheter having an outer diameter adapted to slidingly fit within a lumen of the guiding catheter, iii) an elongate, flexible member coaxially insertable through the lumen of the inner tubular catheter, said elongate flexible member having a proximal end and a distal end, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter, (iv) a braided tubular prosthesis with the proximal ends of individual strands comprising the prosthesis captured between the first bead member and the distal end of the inner tubular catheter (b) routing the guiding catheter through the vascular system until a distal end of the guiding catheter is proximate said selected site; (c) advancing the tubular inner catheter, elongate flexible member and braided tubular prosthesis through the lumen of the outer guiding catheter until the tubular prosthesis is disposed at the distal end of the guiding catheter; (d) manipulating the inner tubular catheter relative to the guiding catheter to expose the braided tubular prosthesis out from the distal end of the guiding catheter; (e) releasing the braided tubular prosthesis from the distal end of the inner tubular catheter when the braided tubular prosthesis is properly located at the selected site or drawing the braided tubular prosthesis back into the guiding catheter when the braided tubular prosthesis is not properly located at the selected site; and (f) repeating step (e) until the tubular prosthesis is properly located at the treatment site.

Claim 46

42 . A method for controllably delivering a braided, self-expanding tubular prosthesis to a selected site in the vascular system comprising the steps of: (a) providing the combination of: i) an outer guiding catheter; ii) A flexible, tubular inner catheter having a proximal end, a distal end and a lumen extending therebetween the inner catheter having an outer diameter adapted to slidingly fit within a lumen of the guiding catheter, iii) an elongate, flexible member coaxially insertable through the lumen of the inner tubular catheter, said elongate flexible member having a proximal end and a distal end, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter, (iv) a braided tubular prosthesis with the proximal ends of individual strands comprising the prosthesis captured between the first bead member and the distal end of the inner tubular catheter (b) routing the guiding catheter through the vascular system until a distal end of the guiding catheter is proximate said selected site; (c) advancing the tubular inner catheter, elongate flexible member and braided tubular prosthesis through the lumen of the outer guiding catheter until the tubular prosthesis is disposed at the distal end of the guiding catheter; (d) manipulating the inner tubular catheter relative to the guiding catheter to expose the braided tubular prosthesis out from the distal end of the guiding catheter; (e) releasing the braided tubular prosthesis from the distal end of the inner tubular catheter when the braided tubular prosthesis is properly located at the selected site or drawing the braided tubular prosthesis back into the guiding catheter when the braided tubular prosthesis is not properly located at the selected site; and (f) repeating step (e) until the tubular prosthesis is properly located at the treatment site.

Claim 47

43 . A method for controllably delivering a braided, self-expanding tubular prosthesis to a selected site in the vascular system comprising the steps of: (a) providing the combination of: i) an outer guiding catheter; ii) an elongated guidewire; iii) a flexible, tubular inner catheter having a proximal end, a distal end and a lumen extending therebetween the inner catheter having an outer diameter adapted to slidingly fit within a lumen of the guiding catheter, iv) an elongate, flexible, tubular member coaxially insertable through the lumen of the inner tubular catheter, said elongate flexible member having a proximal end and a distal end and a lumen extending therebetween for receiving the guidewire therethrough, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter, (v) a braided tubular prosthesis with the proximal ends of individual strands comprising the prosthesis captured between the first bead member and the distal end of the inner tubular catheter (b) routing the guiding catheter through the vascular system until a distal end of the guiding catheter is proximate said selected site; (c) advancing the guidewire through the guiding catheter; (d) advancing the tubular inner catheter, elongate tubular flexible member and braided tubular prosthesis over the guidewire and through the lumen of the outer guiding catheter until the tubular prosthesis is disposed at the distal end of the guiding catheter; (e) manipulating the inner tubular catheter relative to the guiding catheter to expose the braided tubular prosthesis out from the distal end of the guiding catheter; (f) releasing the braided tubular prosthesis from the distal end of the inner tubular catheter when the braided tubular prosthesis is properly located at the selected site or drawing the braided tubular prosthesis back into the guide catheter when the braided tubular prosthesis is not properly located at the selected site; (g) repeating step (f) until the tubular prosthesis is properly located at the treatment site. (h) removing the guiding catheter, the inner catheter, the flexible member and the guidewire from the vascular system.

Claim 48

43 . A method for controllably delivering a braided, self-expanding tubular prosthesis to a selected site in the vascular system comprising the steps of: (a) providing the combination of: i) an outer guiding catheter; ii) an elongated guidewire; iii) a flexible, tubular inner catheter having a proximal end, a distal end and a lumen extending therebetween the inner catheter having an outer diameter adapted to slidingly fit within a lumen of the guiding catheter, iv) an elongate, flexible, tubular member coaxially insertable through the lumen of the inner tubular catheter, said elongate flexible member having a proximal end and a distal end and a lumen extending therebetween for receiving the guidewire therethrough, said distal end having a first bead member affixed thereto sized to at least partially fit within the lumen of the inner tubular catheter at said distal end of the inner tubular catheter when a proximally directed tension force is applied to the elongate flexible member with respect to the inner tubular catheter, (v) a braided tubular prosthesis with the proximal ends of individual strands comprising the prosthesis captured between the first bead member and the distal end of the inner tubular catheter (b) routing the guiding catheter through the vascular system until a distal end of the guiding catheter is proximate said selected site; (c) advancing the guidewire through the guiding catheter; (d) advancing the tubular inner catheter, elongate tubular flexible member and braided tubular prosthesis over the guidewire and through the lumen of the outer guiding catheter until the tubular prosthesis is disposed at the distal end of the guiding catheter; (e) manipulating the inner tubular catheter relative to the guiding catheter to expose the braided tubular prosthesis out from the distal end of the guiding catheter; (f) releasing the braided tubular prosthesis from the distal end of the inner tubular catheter when the braided tubular prosthesis is properly located at the selected site or drawing the braided tubular prosthesis back into the guide catheter when the braided tubular prosthesis is not properly located at the selected site; (g) repeating step (f) until the tubular prosthesis is properly located at the treatment site. (h) removing the guiding catheter, the inner catheter, the flexible member and the guidewire from the vascular system.