Windowed catheter and method of use

• US 5,409,459 A
• Filed: 08/24/1994
• Issued: 04/25/1995
• Est. Priority Date: 03/12/1993
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Gambale, Richard A.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/295,222
• Time in Patent Office: 244 Days
• Field of Search: 604/96-103, 604/49-53, 606/192-196, 600/18
• US Class Current: 604/102.02
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An over-the-wire catheter includes an elongated shaft having a guidewire lumen extending substantially the entire length of the catheter for receiving a guidewire. The catheter has a length relative to the guidewire such that the guidewire can simultaneously extend out the proximal and distal ends of the catheter. The catheter shaft includes a window opening the guidewire lumen to the exterior of the catheter. The window is of such a length and is so located on the shaft that as the catheter is withdrawn proximally over the guidewire, the window is exposed to provide access to the guidewire before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that the distal end of the catheter is exposed to provide access to the guidewire extending therefrom before the proximal end of the guidewire is disposed distal to the window.

Claims

1. A catheter for insertion into a patient over an elongated guidewire having proximal and distal ends, comprising:

an elongated guidewire; and

an elongated catheter shaft having open proximal and distal ends and a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft, the catheter shaft having a length relative to the guidewire such that the guidewire, when received in said lumen, can extend out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter and guidewire have been fully inserted into the patient, the catheter can be withdrawn proximally over the indwelling guidewire and the window can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter, and said catheter element length such that after the catheter and guidewire have been fully inserted into the patient said catheter can also be withdrawn proximally over the indwelling guidewire so that the distal end of the catheter is disposed outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element.

2. A catheter according to claim 1 which further includes an inflatable balloon member disposed on the distal end of the catheter and an inflation lumen extending the length of the catheter and communicating with said balloon, the guidewire lumen and inflation lumen being disposed in side-by-side relationship to one another.

3. A catheter according to claim 1 wherein the catheter shaft further includes reinforcement means disposed adjacent the window element.

4. A method for withdrawing a catheter over a guidewire disposed within a patient while maintaining the guidewire in place in the patient, the guidewire having a proximal end and a distal end, the catheter having an elongated shaft having open proximal and distal ends and a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft, the catheter shaft having a length such that the guidewire receivable in said lumen can extend simultaneously out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter is inserted into the patient, the catheter can be withdrawn proximally over the guidewire and said window element can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that said catheter can also be withdrawn proximally over the guidewire so that the distal end of the catheter is outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element, comprising the steps of:

(a) grasping the proximal end of the guidewire and withdrawing the catheter proximally along the guidewire as much as possible so as to expose the window and render it accessible;

(b) holding the guidewire proximally inside the window while holding the proximal end of the window;

(c) sliding the distal end of the window proximally along a portion of the guidewire;

(d) holding the guidewire distally inside the window while holding the distal end of the window;

(e) sliding the proximal end of the window proximally along a portion of the guidewire;

(f) repeating steps (b) through (e) until the distal end of the catheter is exposed and the guidewire extending therefrom accessible; and

(g) grasping the guidewire distal of the distal end of the catheter and pulling the catheter off the proximal end of the guidewire.

5. A method for inserting an over-the-wire catheter into a patient over a guidewire, the guidewire having a proximal end and a distal end, the catheter having an elongated shaft having open proximal and distal ends and a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft, the catheter shaft having a length such that the guidewire receivable in said lumen can extend simultaneously out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter is inserted into the patient, the catheter can be withdrawn proximally over the guidewire and said window element can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that said catheter can also be withdrawn proximally over the guidewire so that the distal end of the catheter is outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element, comprising the steps of:

(a) inserting the proximal end of the guidewire into the distal end and guidewire lumen of the catheter;

(b) gripping the guidewire disposed distal to the catheter and advancing the catheter distally over the guidewire until the guidewire is disposed within the catheter window;

(c) holding the guidewire distally inside the window while holding the distal end of the window;

(d) sliding the proximal end of the window distally along a portion of the guidewire;

(e) holding the guidewire proximally inside the window while holding the proximal end of the window;

(f) sliding the distal end of the window distally along a portion of the guidewire;

(g) repeating steps (c) through (f) until the proximal end of the guidewire exits the proximal end of the catheter; and

(h) gripping the proximal end of the guidewire and advancing the catheter distally to a desired location in the patient.

6. A method for inserting an over-the-wire catheter into a patient over a guidewire, the guidewire having a proximal end and a distal end, the catheter having an elongated shaft having open proximal and distal ends and a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft, the catheter shaft having a length such that the guidewire receivable in said lumen can extend simultaneously out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter is inserted into the patient, the catheter can be withdrawn proximally over the guidewire and said window element can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that said catheter can also be withdrawn proximally over the guidewire so that the distal end of the catheter is outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element, comprising the steps of:

(a) inserting the proximal end of the guidewire into the distal end and guidewire lumen of the catheter;

(b) gripping the guidewire disposed distal to the catheter and advancing the catheter distally over the guidewire until the guidewire is disposed within the catheter window;

(c) holding the guidewire at the distal end of the window;

(d) sliding the catheter distally along a portion of the guidewire;

(e) repeating steps (c) and (d) until the proximal end of the guidewire exits the proximal end of the catheter; and

(f) gripping the proximal end of the guidewire and advancing the catheter distally to a desired location in the patient.

7. A method for withdrawing a catheter over a guidewire disposed within a patient while maintaining the guidewire in place in the patient, the guidewire having a proximal end and a distal end, the catheter having an elongated shaft having open proximal and distal ends and a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft, the catheter shaft having a length such that the guidewire receivable in said lumen can extend simultaneously out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter is inserted into the patient, the catheter can be withdrawn proximally over the guidewire and said window element can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that said catheter can also be withdrawn proximally over the guidewire so that the distal end of the catheter is outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element, comprising the steps of:

(a) grasping the proximal end of the guidewire and withdrawing the catheter proximally along the guidewire as much as possible so as to expose the window and render it accessible;

(b) holding the guidewire at the proximal end of the window;

(c) sliding the catheter proximally along a portion of the guidewire;

(d) repeating steps (b) and (c) until the distal end of the catheter is exposed and the guidewire extending therefrom accessible; and

(e) grasping the guidewire distal of the distal end of the catheter and pulling the catheter off the proximal end of the guidewire.

8. A catheter for insertion into a patient over an elongated guidewire having proximal and distal ends, comprising:

an elongated catheter shaft having open proximal and distal ends, a longitudinal inflation lumen extending the entire length of the catheter between the open ends of the catheter shaft, a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft and the inflation lumen and guidewire lumen being disposed in side-by-side relationship to one another, the catheter shaft having a length relative to the guidewire such that the guidewire receivable in said lumen can extend out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter has been inserted into the patient, the catheter can be withdrawn proximally over the guidewire and the window can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that said catheter can also be withdrawn proximally over the guidewire so that the distal end of the catheter is disposed outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element;

an inflatable balloon member disposed on the distal end of the catheter and in communication with the inflation lumen; and

a sleeve member slidably disposed over the catheter shaft for selectively opening and closing said window element.

9. A catheter for insertion into a patient over an elongated guidewire having proximal and distal ends, comprising:

an elongated catheter shaft having open proximal and distal ends and a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft, the catheter shaft having a length relative to the guidewire such that the guidewire receivable in said lumen can extend out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter wherein the window element defines a shaft portion of reduced diameter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter has been inserted into the patient, the catheter can be withdrawn proximally over the guidewire and the window can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that said catheter can also be withdrawn proximally over the guidewire so that the distal end of the catheter is disposed outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element; and

a wire support member wound around the reduced diameter portion of the shaft.

10. A catheter for insertion into a patient over an elongated guidewire having proximal and distal ends, comprising:

an elongated catheter shaft having open proximal and distal ends, a longitudinal inflation lumen extending the entire length of the catheter between the open ends of the catheter shaft, a longitudinal guidewire lumen for receiving the guidewire and extending substantially the entire length of the catheter between the open ends of the catheter shaft and the inflation lumen and guidewire lumen being disposed in side-by-side relationship to one another, the catheter shaft having a length relative to the guidewire such that the guidewire receivable in said lumen can extend out the proximal and distal ends of the catheter, said catheter shaft further including a window element opening the guidewire lumen to the exterior of the catheter, the window element having a proximal end and a distal end, the window element being located on the catheter shaft and having a length such that after the catheter has been inserted into the patient, the catheter can be withdrawn proximally over the guidewire and the window can be exposed so as to provide access to the guidewire therethrough before the proximal end of the guidewire is disposed distal to the proximal end of the catheter and such that said catheter can also be withdrawn proximally over the guidewire so that the distal end of the catheter is disposed outside of the patient so as to expose and render accessible a portion of the guidewire extending from the distal end of the catheter before the proximal end of the guidewire is disposed distal to the window element;

an inflatable balloon member disposed on the distal end of the catheter and in communication with the inflation lumen;

a sleeve member slidably disposed over the catheter shaft for selectively opening and closing said window element; and

a first stop disposed proximal to the window and a second stop disposed distal to the window for engaging and locating said sleeve.