Introducer assembly particularly for balloon catheters

Patent metadata

Field	Value
Publication number	US-2023166088-A1
Application number	US-202318162207-A
Country	US
Kind code	A1
Filing date	Jan 31, 2023
Priority date	Dec 11, 2018
Publication date	Jun 1, 2023
Grant date	—

Abstract

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.

First claim

1 . An introducer assembly including:
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 and distal ends, 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 in use simultaneously open, the guide wire lumen and side opening being able 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 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;
whereby 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 a guide wire fed from the distal end of the catheter is caused to pass from the distal end through the side opening, the catheter being curvable such that at least a part of the side opening becomes linearly aligned with guide wire lumen between distal end and side opening.

2 . An introducer assembly according to claim 1 , wherein the stiffening element extends from the proximal end of the catheter to a position distal of the side opening.

3 . An introducer assembly according to claim 1 , wherein the catheter includes a second stiffening mandrel fixed relative to the catheter, the first and second the mandrels having different lengths.

4 . An 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 . An 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 a guide wire through the side opening.

6 . An introducer assembly according to according to claim 1 , wherein the side opening has a length of between 1.5 and 10 times a diameter of the lumen.

7 . An introducer assembly according to 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; between 3 cm and 10 cm; or between 5 cm and 10 cm proximal of the medical balloon.

8 . An introducer assembly according to claim 7 , wherein the catheter includes a balloon inflation lumen extending from the proximal end to an inlet/outlet port located within a chamber of the medical balloon, the balloon inflation lumen being separate from the guide wire lumen.

9 . An introducer assembly according to claim 8 , wherein the outer catheter wall is strengthened at the side opening.

10 . An introducer assembly according to claim 9 , wherein the catheter strengthening includes:
a sleeve overlying the catheter portion at the side opening, the sleeve having an aperture so as to allow access to the side opening; or first and second bands of strengthening material either end of the side opening.

11 . An introducer assembly according to claim 10 , wherein the sleeve or bands of strengthening material are made of or include radiopaque or MRI visible material.

12 . An introducer assembly according to claim 1 , including a guide element comprising a curved or bent guide channel and a straight guide channel, the curved guide channel being configured for loading a guide wire into the catheter in a rapid exchange configuration and the straight guide channel being configured for loading a guide wire into the catheter in an over-the-wire configuration.

13 . An introducer assembly kit including:
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, and an outer catheter wall; the catheter including: (i) a medical device holding portion proximate the distal end thereof, (ii) a guide wire lumen extending between the proximal and distal ends, a fluid supply coupling to the guide wire lumen being provided at the proximal of the catheter; and (iii) a side opening extending through the outer wall to the guide wire lumen between a proximal portion of the guide wire lumen and a distal portion of the guide wire lumen, wherein the side opening and the guide wire lumen are in use simultaneously open, the guide wire lumen and side opening being able to receive a guide wire therethrough; the catheter being flexible at least in the location of the side opening; a source of fluid agent including a fluid source coupling configured to couple to the fluid supply coupling of the catheter and thereby to couple a supply of fluid agent to the guide wire lumen; whereby the assembly is configurable to dispose the guide wire through the side opening and in the distal portion of the guide wire lumen, and to dispense fluid agent through the proximal portion of the guide wire lumen from the proximal end of the catheter, whereby when the guide wire is disposed in the distal portion or the guide wire lumen the guide wire impedes passage of fluid agent through the distal portion of the guide wire lumen such that fluid agent from the proximal portion of the guide wire lumen exits the catheter at the side opening.

14 - 19 . (canceled)

20 . An introducer assembly including:
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 and distal ends, (iii) a side opening extending through the outer catheter wall to the guide wire lumen, (iv) a mandrel lumen extending across the side opening, the mandrel lumen having a closed proximal end and a closed distal end; and a kink resistance element in the form of a mandrel enclosed within the mandrel lumen, the mandrel having a length greater than the length of the side opening and extending across the side opening.

21 - 27 . (canceled)

28 . The introducer assembly according to claim 20 , further 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.

29 . The introducer assembly according to claim 20 , wherein the guide wire lumen remains open between the proximal and distal ends of the catheter when the catheter is curved to allow a guide wire through the side opening.

30 . The introducer assembly according to claim 20 , wherein the side opening has a length of between 1.5 and 10 times a diameter of the guide wire lumen.

31 - 37 . (canceled)

38 . A

Assignees

• Cook Medical Technologies Llc

Inventors

• Klausen Kasper
• Hansen Palle Munk
• Lundsteen Nicholas Gulmann

Classifications

• A61M2025/09008

  having a balloon · CPC title

• A61M25/0052

  Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port · CPC title

• A61M25/0169

  Exchanging a catheter while keeping the guidewire in place · CPC title

• A61M2025/09166

  having radio-opaque features · CPC title

• A61M2025/0183

  Rapid exchange or monorail catheters · CPC title