Endovascular grafting apparatus and system

Claim 2

A system as in Claim 1 together with a balloon catheter comprised of a flexible elongate member having proximal and distal extremities and a balloon secured to the distal extremity of the flexible elongate member, the flexible elongate member of the balloon catheter having a balloon inflation lumen extending through the flexible elongate member of the capsule catheter and means for inflating and deflating the balloon through the balloon inflation lumen of the flexible elongate member of the balloon catheter.

Claim 3

A system as in Claim 2 wherein said balloon catheter includes a rigid metallic tube extending through the balloon and in communication with the balloon inflation lumen.

Claim 4

A system as in Claim 3 wherein said push rod means includes a wire extending through said rigid metallic tube.

Claim 5

A system as in Claim 4 wherein said balloon catheter includes a plug distal of the balloon engageable by said wire.

Claim 6

A system as in Claim 2 together with a pusher button mounted on the flexible elongate member of the balloon catheter and engaging the graft.

Claim 7

A system as in Claim 6 wherein the pusher rod engages the pusher button.

Claim 8

A system as in Claim 6 wherein said pusher button is mounted in a fixed position on the flexible elongate member of the balloon catheter.

Claim 9

A system as in Claim 6 wherein said pusher button is mounted on said flexible elongate member with the balloon catheter so that it is movable between one position spaced from the proximal extremity of the balloon and another position adjacent to the proximal extremity of the balloon.

Claim 10

A capsule catheter comprising, a flexible elongate element having proximal and distal extremities, a capsule mounted on the distal extremity, said capsule being formed of helical wraps of a metal ribbon to provide a cylindrical capsule and means engaging said wraps for retaining said wraps in said cylindrical capsule to prevent discontinuities occurring in said wraps when said capsule is bent through angles ranging up to approximately 120°.

Claim 11

A capsule catheter as in Claim 10 together with a plurality of spaced apart flexible elongate elements extending longitudinally of the capsule exterior of the capsule and secured to the proximal and distal extremities of the capsule for preventing separation of the wraps of the capsule upon bending of the capsule.

Claim 12

A capsule catheter as in Claim 11 wherein said flexible elongate elements are formed of Kevlar.

Claim 13

A capsule catheter as in Claim 10 wherein said metal is stainless steel.

Claim 14

A capsule catheter as in Claim 10 together with an inner tubular lumen disposed within said flexible elongate element and means carried by the flexible elongate element for retaining said inner liner within said flexible elongate element.

Claim 15

A capsule catheter as in Claim 14 together with a fitting carried by the proximal extremity of the flexible elongate element for introducing a fluid through the flexible elongate element.

Claim 16

A capsule catheter as in Claim 10 wherein said capsule has a diameter ranging from .20 to .300 inches and has a length ranging from 8 to 20 centimeters.

Claim 17

A capsule catheter as in Claim 10 wherein said ribbon has a thickness of .002 to .005 inches and a width of approximately .150 inches.

Claim 18

A capsule catheter as in Claim 10 together with a sheath of heat shrinkable material extending over the exterior of the helical wraps.

Claim 19

A balloon catheter assembly comprising a flexible elongate element having a balloon inflation lumen extending therethrough, said flexible elongate element having proximal and distal extremities, a balloon having proximal and distal extremities carried by the distal extremity of the flexible elongate element and a rigid tubular member extending through the balloon and having a bore therein in communication with the lumen in the flexible elongate element, the interior of the balloon being in communication with the distal extremity of the rigid tubular member.

Claim 20

A balloon catheter as in Claim 19 together with a fixed guide wire formed of a coil spring and having a proximal extremity and means securing the proximal extremity of the guide wire to the distal extremity of the balloon.

Claim 21

A balloon catheter as in Claim 19 together with a pusher button carried by the flexible elongate member and stop means preventing movement of said pusher button longitudinally of the flexible elongate member beyond a predetermined location spaced from the proximal extremity of the balloon but permitting movement of such pusher button between said predetermined location and the proximal extremity of the balloon .

Claim 22

A balloon catheter as in Claim 21 together with additional stop means for preventing longitudinal movement from the predetermined location.

Claim 23

A balloon catheter as in Claim 21 wherein said flexible elongate member is formed of an irradiated plastic and wherein said stop means is formed from said irradiated plastic.

Claim 24

A balloon catheter as in Claim 19 together with plug means carried by the distal extremity of the balloon.

Claim 25

A pusher rod assembly for use with an elongate catheter comprising a metal elongate tubular member having proximal and distal extremities and having a bore extending therethrough, a knob secured to the proximal extremity and adapted to be grasped by a human hand.

Claim 26

An assembly as in Claim 25 together with a flexible wire secured to the tubular member extending centrally through the bore in said tubular member and having a length so that it extends beyond the length of the tubular member.

Claim 27

A pusher rod assembly as in Claim 26 wherein said pusher rod has an inside diameter of .053 inches and wherein said wire has a diameter of .018 inches.

Claim 28

A pusher rod assembly as in Claim 26 wherein said tubular member and said wall are formed of stainless steel.

Claim 29

An expandable intraluminal vascular graft for implanting in a body vessel comprising a deformable tubular member having proximal and distal ends and a wall extending between the proximal and distal ends, the wall being formed of a flexible material capable of receiving tissue ingrowth, said tubular member being capable of assuming a first position of reduced size for insertion into the body vessel and a second expanded position, expandable yieldable spring means secured to the proximal and distal extremities of the tubular member, said yieldable spring means urging said tubular member from said first position of reduced size to a second expanded position and attachment means secured to said expandable spring means for attachment to the body vessel.

Claim 30

A graft as in Claim 29 wherein said expandable spring means is in the form of substantially vee-shaped spring portions having apices and legs extending from the apices, the spring means having a helical torsion spring at each apex yieldably urging said legs in a direction to open the vee shaped spring portions.

Claim 31

A graft as in Claim 29 wherein said expandable spring means includes a plurality of interconnected vees with each vee having an apex and with coil spring means formed at each apex serving to expand the vees in an outward direction along the plane of each of the vees.

Claim 32

A graft as in Claim 29 wherein the attachment means is in the form of hook-like elements secured to the spring means in the vicinity of the apices of the vees.

Claim 33

A graft as in Claim 32 wherein the apices of the vees lie in first and second planes spaced longitudinally of the longitudinal axis of the graft.

Claim 34

A graft as in Claim 33 wherein the apices in the first and second planes are spaced beyond the end of the tubular member and wherein the hook-like elements are mounted on the vees in the vicinity of the apices lying in the first and second planes.

Claim 35

A graft as in Claim 34 wherein the apices in the first and second planes are offset circumferentially with respect to the apices in the other of the first and second planes.

Claim 36

A graft as in Claim 35 wherein at least three apices are provided in the first plane and at least three apices are provided in the second plane.

Claim 37

A graft as in Claim 29 together with radiopaque marker means secured to the wall of the tubular member, said marker means including first and second aligned radiopaque markers spaced apart longitudinally of the tubular member to permit ascertaining whether any twisting of the tubular member has occurred.

Claim 38

A graft as in Claim 37 wherein the first and second markers are positioned adjacent apices of the yieldable spring means.

Claim 39

A pusher rod assembly for use with an elongate catheter comprising a metal elongate tubular member having proximal and distal extremities and having a bore extending therethrough and a knob adapted to be grasped by the hand secured to the proximal extremity of the tubular member, said knob having a hole therein in registration with the bore in the tubular member.

Claim 40

A pusher rod assembly as in Claim 39 together with a flexible guide wire extending through the bore in the elongate tubular member and through the hole in the knob.

Claim 41

A pusher rod assembly for use with an elongate catheter comprising a metal elongate tubular member having proximal and distal extremities and having a bore extending therethrough, an adapter secured to the proximal extremity of the elongate tubular member, said adapter having a hole extending therethrough, a flexible wire extending through the bore in the tubular member and extending through the hole in the adapter, the wire having proximal and distal extremities and a knob secured to the proximal extremity of the wire.

Claim 42

An expandable intraluminal vascular graft for implanting in a body vessel comprising a deformable tubular member having proximal and distal extremities and a wall extending between the proximal and distal extremities, the wall being formed of a flexible material capable of receiving tissue ingrowth, attachment means secured to the proximal and distal extremities of the deformable tubular member, said attachment means at the proximal extremities including hook-like elements spaced circumferentially around the proximal extremity and having protrusions extending therefrom at an angle ranging from 55° to 80° from the longitudinal and in a direction which is facing towards the distal extremity of the tubular member, the attachment means for the distal extremity including hook-like elements spaced circumferentially around the distal extremity and having projections extending therefrom which are inclined from the vertical by 30° to 90° in a direction facing towards the proximal extremity of the tubular member so that the hook-like elements on the proximal and distal extremities face towards each other to facilitate holding the graft in place in the vessel.

Claim 43

In a method for implanting an expandable intraluminal vascular graft into a body vessel of a patient, by the use of a capsule catheter comprising a flexible elongate tubular member having proximal and distal extremities and a capsule mounted on the distal extremity of the tubular member, a graft having proximal and distal extremities and having hook-like attachment means secured to the proximal and distal extremities, said graft being compressed within said tubular member, a balloon catheter comprised of a flexible elongate member having proximal and distal extremities and a balloon secured to the distal extremity of the flexible elongate member and a pusher button secured to the flexible elongate member of the balloon catheter and spaced from the proximal extremity of the balloon with the flexible elongate member of the balloon catheter extending through the capsule, through the graft and through the flexible elongate member of the capsule catheter and positioned so that the pusher button is disposed within the graft and the capsule catheter and with the balloon being disposed outside of the capsule catheter and a pusher rod assembly, the method comprising the steps of advancing the pusher rod assembly along the flexible elongate tubular member of the capsule catheter and causing a force to be applied to the pusher button by relative movement between the proximal extremity of the graft within the capsule and the capsule to cause ejection of the proximal extremity of the graft from the capsule, removing the pusher rod assembly, grasping the flexible elongate member of the balloon catheter and pulling the proximal extremity of the balloon into the graft while holding the capsule catheter stationary and inflating the balloon to seat the attachment means carried by the proximal extremity of the graft into the vessel of the patient.

Claim 44

A method as in Claim 43 wherein the step of applying force to the pusher button is accomplished by using the pusher rod assembly to place a force upon the distal extremity of the balloon whereby a force is transferred from the distal extremity of the balloon through the flexible elongate member of the balloon catheter to the pusher button.

Claim 45

A method as in Claim 43 wherein the step of applying a force to the pusher button is accomplished by causing the pusher rod assembly to directly engage the pusher button.

Claim 46

A method as in Claim 43 wherein the balloon is provided with a memorized helical wrap and wherein the balloon catheter assembly while being introduced into the vessel of the patient is rotated in the direction of the helical wrap to provide a balloon having a reduced profile during the time it is being introduced into the vessel of the patient.

Claim 47

An expandable intraluminal vascular graft for implanting in a body vessel comprising a deformable tubular member having proximal and distal extremities and a wall extending between the proximal and distal extremities, attachment means secured to the proximal and distal extremities, the attachment means including hook-like elements, the hook-like elements extending outwardly with the hook-like elements on the proximal and distal extremities face each other.

Claim 48

A graft as in Claim 47 wherein the hook-like elements on the proximal extremity have an angle extending from the longitudinal axis ranging from 55° to 80° in a direction facing the distal extremity of the graft and wherein the hook-like elements on the distal extremity extend outwardly from the vertical in a direction ranging from 30° to 90° facing towards the proximal extremity of the graft.