Fast purge balloon dilatation catheter

• US 5,100,385 A
• Filed: 09/28/1990
• Issued: 03/31/1992
• Est. Priority Date: 01/27/1989
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Bromander, Roy C.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Cermak, Adam
• Application Number:
  US07/590,339
• Time in Patent Office: 550 Days
• Field of Search: 604/96-103, 604/52, 604/53, 604/164, 604/167, 604/246, 606/192-196, 128/207.15-207.17
• US Class Current: 604/99.03
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon dilatation catheter having a guidewire lumen that extends to the distal tip of the catheter, a balloon mounted on the distal end of the catheter and an inflation lumen extending through the shaft and communicating with the interior of the balloon is provided with an improved arrangement for filling the inflation lumen and balloon with liquid while purging air from the system. The device includes a one-way valve means carried by the catheter shaft within the balloon which permits fluid flow from the guidewire lumen into the balloon under a predetermined pressure greater than about one atmosphere. The system is used by first plugging the distal end of the guidewire lumen and then pressurizing the guidewire lumen with inflation liquid sufficiently to open the one-way valve means to permit inflation liquid to fill the balloon. As the balloon fills, air is forced out of the balloon through the inflation lumen and is vented through the open proximal end of the inflation lumen. The one-way valve means is constructed to preclude reverse flow under pressures greater than 20 atm and to preclude opening in response to aspiration through the inflation lumen at a level not greater than 1 atmosphere pressure.

Claims

1. A balloon dilatation catheter comprising:

an elongate flexible shaft having a proximal end and a distal end and a guidewire lumen open at the distal end of the shaft;

a balloon mounted on and about the distal end of the shaft;

the shaft having an inflation lumen extending along its length, the distal end of the inflation lumen being in fluid communication with the interior of the balloon to permit inflation and deflation of the balloon; and

one-way valve means on that portion of the shaft disposed within the balloon for permitting flow of liquid from the main lumen into the balloon when the liquid in the main lumen reaches a predetermined pressure while preventing reverse flow therethrough said one-way valve means being constructed and arranged to prevent said reverse flow up to pressures of the order of 20 atm.

2. A method for purging air from the balloon of a dilatation catheter comprising:

providing a catheter including an elongate flexible shaft having a proximal end and a distal end and a guidewire lumen open at the distal end of the shaft;

a balloon mounted on and about the distal end of the shaft;

the shaft having an inflation lumen extending along its length, the distal end of the inflation lumen being in fluid communication with the interior of the balloon to permit inflation and deflation of the balloon; and

one-way valve means on that portion of the shaft disposed within the balloon for permitting flow of liquid from the main lumen into the balloon when the liquid in the main lumen reaches a predetermined pressure while preventing reverse flow therethrough;

plugging the distal opening of the guidewire lumen;

injecting liquid under pressure into the guidewire lumen under sufficient pressure to open the one-way valve means and to cause liquid to flow therethrough and to fill the balloon with liquid while permitting air to escape in a proximal direction through the inflation lumen;

after the balloon and inflation lumen are substantially filled with said liquid, unplugging the distal opening of the main lumen.

3. A method as defined in claim 2 further comprising thereafter applying a net negative pressure to the inflation lumen, said one-way valve means maintaining the flow passage closed.

4. A balloon dilatation catheter comprising:

an elongate flexible shaft having a proximal end and a distal end and a guidewire lumen open at the distal end of the shaft;

a balloon mounted on and about the distal end of the shaft;

the shaft having an inflation lumen extending along its length, the distal end of the inflation lumen being in fluid communication with the interior of the balloon to permit inflation and deflation of the balloon; and

one-way valve means on that portion of the shaft disposed within the balloon for permitting flow of liquid from the main lumen into the balloon when the liquid in the main lumen reaches a predetermined pressure greater than about 1 atm while preventing reverse flow therethrough, said one-way valve means being constructed and arranged to prevent said reverse flow up to pressures of the order of 20 atm.

5. A balloon dilatation catheter comprising:

an elongate flexible shaft having a proximal end and a distal end and a guidewire lumen open at the distal end of the shaft;

a balloon mounted on and about the distal end of the shaft;

the shaft having an inflation lumen extending along its length, the distal end of the inflation lumen being in fluid communication with the interior of the balloon to permit inflation and deflation of the balloon; and

one-way valve means on that portion of the shaft disposed within the balloon for permitting flow of liquid from the main lumen into the balloon when the liquid in the main lumen reaches a predetermined pressure while preventing reverse flow therethrough, said valve means comprising a flow passage formed in the wall of the shaft between the guidewire lumen and the interior of the balloon, and an elastic sleeve on the shaft disposed over the flow passage, said valve means being constructed and arranged to prevent said reverse flow up to pressures of the order of 20 atm.

6. A balloon dilatation catheter comprising:

an elongate flexible shaft having a proximal end and a distal end and a guidewire lumen open at the distal end of the shaft;

a balloon mounted on and about the distal end of the shaft;

the shaft having an inflation lumen extending along its length, the distal end of the inflation lumen being in fluid communication with the interior of the balloon to permit inflation and deflation of the balloon; and

one-way valve means on that portion of the shaft disposed within the balloon for permitting flow of liquid from the main lumen into the balloon when the liquid in the main lumen reaches a predetermined pressure while preventing reverse flow therethrough, said valve means comprising a slit formed in the wall of the catheter shaft between the guidewire lumen and the interior of the balloon, and an elastic sleeve on the shaft disposed over the slit, said valve means being constructed and arranged to prevent said reverse flow up to pressures of the order of 20 atm.

7. A balloon dilatation catheter purgeable from a source of pressurized liquid, the catheter comprising:

an elongate flexible shaft having a proximal end and a distal end;

a guidewire lumen extending through the shaft, said guidewire lumen being open through the distal shaft end so that a guidewire can be extended along the guidewire lumen to project from the distal shaft end; and

an inflation lumen extending from the shaft proximal end through the shaft, the inflation lumen having an opening at the shaft proximal end;

a balloon mounted on the distal end of the shaft, the balloon having an interior in fluid communication with the inflation lumen to permit inflation and deflation of the balloon with liquid;

a one-way valve connecting the guidewire lumen to the balloon interior constructed to prevent a reverse flow from the balloon interior to the guidewire lumen up to pressures of the order of 20 atm;

means for temporarily blocking the guidewire lumen opening; and

means for temporarily connecting the blocked guidewire lumen to the pressurized liquid source so that pressurized liquid enters the balloon interior through the valve and causes gas in the balloon interior to exit the balloon interior by means of the inflation lumen through the inflation lumen opening at the shaft proximal end.

8. In a vascular balloon dilatation catheter having an elongate flexible shaft having a proximal end and a distal end, the shaft having a guidewire lumen extending through the shaft and being open through the distal end so that a guidewire can be extended along the guidewire lumen to project from the distal shaft end, an inflation lumen extending from the shaft proximal end through the shaft, the inflation lumen having an opening at the shaft proximal end, and a balloon mounted on the distal end of the shaft, the balloon having an interior in fluid communication with the inflation lumen to permit inflation and deflation of the balloon with liquid, apparatus for purging the balloon of gas and filling the balloon with liquid from a pressurized liquid source before insertion into a patient'"'"'s vasculature, said apparatus comprising:

a one-way valve connecting the guidewire lumen to the balloon interior wherein the one-way valve comprises a slit formed in the wall of the shaft between the guidewire lumen and the balloon interior and an elastic sleeve on the shaft disposed over the slit, the elastic sleeve having sufficient elasticity that the sleeve will withstand liquid pressures in the balloon interior when the balloon is inflated on the order of 20 atmospheres without permitting a reverse flow from the balloon interior to the guidewire lumen;

means for temporarily blocking the guidewire lumen opening; and

means for temporarily connecting the blocked guidewire lumen to the pressurized liquid source so that pressurized liquid enters the balloon interior through the valve and causes gas in the balloon interior to exit the balloon interior by means of the inflation lumen through the inflation lumen opening at the shaft proximal end.