Introducer assembly particularly for balloon catheters
An introducer assembly ( 10 ) includes a catheter ( 12 ) having a proximal end ( 14 ), a distal end ( 16 ) extending to a distal tip of the introducer assembly, and an outer catheter wall. The catheter ( 12 ) includes a medical device holding portion ( 34 ) proximate the distal end, a guide wire lumen ( 100 ) extending between the proximal and distal ends, and a side opening ( 50 ) extending through the outer wall to the guide wire lumen. The side opening ( 50 ) and the guide wire lumen ( 100 ) are simultaneously open and the guide wire lumen and side opening are able to receive a guide wire therethrough. The catheter ( 12 ) is flexible at least in the location of the side opening, such that a guide wire ( 28 ) fed from the distal end ( 16 ) can pass through to the proximal end ( 14 ) when the catheter is substantially straight and can pass from the distal end through the side opening ( 50 ) when the catheter is curved at the location of the side opening. The catheter ( 12 ) also includes a plurality of one stiffening mandrel lumens ( 104, 106 ) extending from the proximal end ( 14 ) and a plurality of stiffening mandrels sized to fit within the stiffening mandrel lumens and in some forms able to slide therewithin and in other forms enclosed within the stiffening mandrel lumens. The mandrels have different lengths disposed along the length of the catheter and can be of substantially uniform diameter.
1 . An introducer assembly including:
(a) a catheter having a proximal end disposed at a proximal location of the introducer assembly, a distal end extending to a distal tip of the introducer assembly, an outer catheter wall, and having a longitudinal dimension; the catheter including:
(i) a medical device holding portion proximate the distal end thereof,
(ii) a guide wire lumen extending between the proximal end and the distal end, and
(iii) an elongate side opening extending through the outer wall to the guide wire lumen, the side opening having a length, a width and being elongate in the longitudinal dimension of the catheter;
wherein the side opening and the guide wire lumen are configured to receive a guide wire therethrough;
the catheter being flexible at least in the location of the side opening;
a kink resistance element in the form of a first mandrel made of a metal or metal alloy disposed in a lumen of the catheter and fixed to the catheter, the mandrel having a length greater than the length of the side opening and extending across the side opening;
wherein a guide wire fed from the distal end of the catheter passes through the guide wire lumen to the proximal end when the catheter is substantially straight; and when catheter is curved in a first curved condition a guide wire fed from the distal end of the catheter is caused to pass through the guide wire lumen from the distal end through the side opening, the catheter being curvable to the first curved condition such that at least a part of the side opening becomes linearly aligned with the guide wire lumen between the distal end and the side opening; and
(b) a guide element comprising a curved guide channel and a straight guide channel, the curved guide channel having a first open side along an entire length of the curved guide channel and being configured to receive the catheter through the first open side and thereby position the catheter in the first curved condition for loading the guide wire into the guide wire lumen of the catheter in a rapid exchange configuration, and the straight guide channel having a second open side along an entire length of the straight guide channel and being configured to receive the catheter through the second open side and thereby position the catheter in a straight condition for loading the guide wire into the guide wire lumen of the catheter in an over-the-wire configuration; and
wherein the catheter is received in the curved guide channel with the side opening of the catheter positioned along the curved guide channel or is received in the straight guide channel with the side opening of the catheter positioned along the straight guide channel.
2 . The introducer assembly according to claim 1 , wherein the kink resistance element extends from the proximal end of the catheter to a position distal of the side opening.
3 . The introducer assembly according to claim 1 , wherein the catheter includes a second stiffening mandrel fixed relative to the catheter, the first mandrel and the second stiffening mandrel having different lengths.
4 . The introducer assembly according to claim 1 , including a stiffening mandrel sized to fit within the guide wire lumen from the proximal end of the catheter to the location of the side opening, said stiffening mandrel being slidable within the guide wire lumen.
5 . The introducer assembly according to claim 1 , wherein the guide wire lumen remains open between the proximal and distal ends of the catheter when the catheter is curved to allow the guide wire through the side opening.
6 . The introducer assembly according to claim 1 , wherein the side opening has a length of between 1.5 and 10 times a diameter of the guide wire lumen.
7 . The introducer assembly according to claim 6 , wherein the assembly is a balloon catheter and includes a medical balloon attached to the catheter at the medical device holding portion, the side opening being disposed between 3 and 20 centimetres proximal of the medical balloon.
8 . The introducer assembly according to claim 7 , wherein the catheter includes a balloon inflation lumen extending from the proximal end to a port located within a chamber of the medical balloon, the balloon inflation lumen being separate from the guide wire lumen.
9 . The introducer assembly according to claim 8 , wherein the outer catheter wall is strengthened at the side opening.
10 . The introducer assembly according to claim 9 , wherein the catheter wall is strengthened at the side opening by a sleeve overlying the catheter portion at the side opening, the sleeve having an aperture so as to allow access to the side opening.
11 . The introducer assembly according to claim 10 , wherein the sleeve is made of or includes radiopaque or MRI visible material.
12 . The introducer assembly according to claim 1 , wherein:
the curved guide channel includes a first guide flange and a second guide flange spaced from the first guide flange;
the curved guide channel includes a curved guide channel portion between the first guide flange and the second guide flange, the curved guide channel portion defining an apex; and
the first guide flange and the second guide flange are configured to laterally receive and hold the catheter within the curved guide channel with a segment of the catheter in which the side opening occurs extending through the curved guide channel portion between the first guide flange and the second guide flange.
13 . The introducer assembly according to claim 12 , wherein the second guide flange is angled 5° to 30° relative to the first guide flange.
14 . The introducer assembly according to claim 13 , wherein an inner curvature of the curved guide channel portion has a radius at the apex of between 5 mm and 15 mm.