Hydraulic exchange catheter

• US 6,027,474 A
• Filed: 09/30/1998
• Issued: 02/22/2000
• Est. Priority Date: 09/30/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Douk, Nareak, Berthiaume, William A.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): KLINE, ERIC E
• Application Number:
  US09/164,006
• Time in Patent Office: 510 Days
• Field of Search: 604/95, 604/96, 604/158, 604/159, 604/161, 604/528, 604/533, 604/534, 604/535, 604/102, 604/164, 604/264, 604/523, 604/905, 606/191, 606/192, 606/194, 606/193, 600/433-435
• US Class Current: 604/95.01
• CPC Class Codes: A61M 25/0169 Exchanging a catheter while keeping the guidewire in place
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

The invention relates to a catheter device and method of use for exchanging a catheter having a full-length guidewire lumen over a conventional-length guidewire without the use of a guidewire extension or an exchange wire. The catheter device includes an elongated shaft defining an inflation lumen and a guidewire lumen extending longitudinally throughout its length, and a hydraulic exchange lumen extending from the proximal end of the shaft and terminating proximal the distal end of the shaft, wherein the hydraulic exchange lumen is in fluid communication with the guidewire lumen. A balloon is coupled to the distal section of the shaft and is in fluid communication with the inflation lumen. A flow guiding member is disposed within the guiding catheter and functions to redirect the distal flow of pressurized fluid traveling through the hydraulic exchange lumen in a proximal direction through the guidewire lumen.

Claims

1. A catheter device adapted for use with a conventional length guidewire, comprising:

(a) an elongated, flexible shaft having a proximal section and a distal section, the shaft defining

(i) an inflation lumen extending longitudinally through the shaft from an open proximal end formed at the proximal section of the shaft to an open distal end formed at the distal section of the shaft;

(ii) a guidewire lumen extending longitudinally through the shaft from an open proximal end formed at the proximal section of the shaft to an open distal end formed at the distal section of the shaft;

(iii) a hydraulic exchange lumen extending longitudinally through the shaft from an open proximal end formed at the shaft proximal section to a closed distal end terminating proximal the distal section of the shaft, the hydraulic exchange lumen having an outlet port proximal its closed distal end through which it is in fluid communication with the guidewire lumen;

(b) a balloon member coupled to the distal section of the shaft, the balloon member defining an interior cavity in fluid communication with the distal end of the inflation lumen;

(c) a flow guiding member disposed within the guidewire lumen, wherein the flow guiding member is adapted to redirect the distal flow of pressurized fluid traveling through the hydraulic exchange lumen in a proximal direction through the guidewire lumen.

2. The catheter device of claim 1, which further comprises a first fitting in fluid communication with the inflation lumen, a second fitting in fluid communication with the guidewire lumen and a third fitting in fluid communication with the hydraulic exchange lumen, wherein each fitting is adapted to enable fluid communication with a source of pressurized fluid.

3. The catheter device of claim 1, wherein the flow guiding member comprises a tube disposed longitudinally within the guidewire lumen and having an open distal end coupled within the guidewire lumen at a position distal of the outlet end port and an open proximal end positioned proximal of the outlet port.

4. The catheter device of claim 1, wherein the flow guiding member comprises a reduced diameter section within the guidewire lumen at a position distal of the outlet port.

5. A catheter device adapted for use with a conventional length guidewire, comprising:

(a) a proximal shaft segment having a proximal end and a distal end, the proximal shaft segment defining

(i) an inflation lumen extending longitudinally through the proximal shaft segment from an open proximal end formed at the proximal end of the proximal shaft segment to an open distal end formed at the distal end of the proximal shaft segment;

(ii) a guidewire lumen extending longitudinally through the proximal shaft segment from an open proximal end formed at the proximal of the proximal shaft segment to an open distal end formed at the distal end of the proximal shaft segment;

(iii) a hydraulic exchange lumen extending longitudinally through the proximal shaft segment from an open proximal end formed at the proximal end of the proximal shaft segment to a closed distal end terminating proximal the distal end of the proximal shaft segment, the hydraulic exchange lumen having an outlet port proximal its closed distal end through which it is in fluid communication with the guidewire lumen;

(b) a distal shaft segment having a distal end and a proximal end coupled to the distal end of the proximal shaft segment, the distal shaft segment defining

(i) an inflation extension lumen extending longitudinally through the distal shaft segment from an open proximal end formed at the proximal end of the distal shaft segment to an open distal end formed at the distal end of the distal shaft segment, the inflation extension lumen being in fluid communication with the inflation lumen and forming a continuous flow passageway throughout;

(ii) a guidewire extension lumen extending longitudinally through the distal shaft segment from an open proximal end formed at the proximal of the distal shaft segment to an open distal end formed at the distal end of the distal shaft segment, the guidewire extension lumen being in fluid communication with the guidewire lumen and forming a continuous flow passageway throughout;

(c) a balloon member coupled adjacent the distal end of the distal shaft segment, the balloon member defining an interior cavity in fluid communication with the distal end of the inflation extension lumen;

(d) a flow guiding member disposed within the guidewire lumen, wherein the flow guiding member is adapted to redirect the distal flow of pressurized fluid traveling through the hydraulic exchange lumen in a proximal direction through the guidewire lumen.

6. The catheter device of claim 5, which further comprises a first fitting in fluid communication with the inflation lumen, a second fitting in fluid communication with the guidewire lumen and a third fitting in fluid communication with the hydraulic exchange lumen, wherein each fitting is adapted to enable fluid communication with a source of pressurized fluid.

7. The catheter device of claim 5, wherein the flow guiding member comprises a tube disposed longitudinally within the guidewire lumen and having an open distal end coupled within the guidewire lumen at a position distal of the outlet end port and, an open proximal end positioned proximal of the outlet port.

8. The catheter device of claim 5, wherein the flow guiding member comprises a reduced diameter section within the guidewire lumen at a position distal of the outlet port.

9. The catheter device of claim 5, wherein the flow guiding member comprises a reduced diameter section formed within the guidewire extension lumen at a position distal of the outlet port.

10. The catheter device of claim 9, wherein the reduced diameter section is formed by a lumen narrowing disposed within the guidewire extension lumen.

11. The catheter device of claim 5, wherein the flow guiding member comprises a reduced diameter section formed by a lumen narrowing having a distal end extending into the proximal section of the guidewire extension lumen and a proximal end extending into the distal section of the guidewire lumen.

12. A method for loading a catheter device having a full-length guidewire lumen over a conventional-length guidewire without the use of an exchange guidewire or a guidewire extension, the catheter device comprising an elongated shaft having a proximal end, a distal end, the shaft defining an inflation lumen and a guidewire lumen extending longitudinally throughout its length, and a hydraulic exchange lumen extending from the shaft proximal end and terminating at a position proximal the shaft distal end, the hydraulic exchange lumen being in fluid communication with the guidewire lumen, a balloon member coupled adjacent the distal end of the shaft, the balloon member defining an interior cavity in fluid communication with the inflation lumen, and a flow guiding member disposed within the guidewire lumen for redirecting the distal flow of pressurized fluid traveling through the hydraulic exchange lumen in a proximal direction through the guidewire lumen, the method comprising the steps of:

(a) inserting a guiding catheter in a patient'"'"'s vasculature;

(b) disposing an adapter at the proximal end of the guiding catheter at a position outside the patient;

(c) opening the adapter and inserting a conventional length guidewire having a distal end and a proximal end into the guiding catheter and advancing the distal end of the guidewire to a treatment site within the patient'"'"'s vasculature;

(d) maintaining the distal end of the guidewire across the treatment site and loading the distal end of the catheter guidewire lumen over the proximal end of the guidewire and advancing the catheter through the adapter into the guiding catheter;

(e) advancing the catheter over the guidewire until the distal end of the catheter is immediately proximal the adapter;

(f) injecting fluid into the proximal end of the hydraulic exchange lumen under constant and steady pressure, thereby advancing the catheter over the guidewire into the patient'"'"'s vasculature until the proximal end of the guidewire protrudes from the proximal end of the guidewire lumen;

(g) gripping the proximal end of the guidewire and grasping and pushing the catheter toward the adapter until the balloon member is positioned across the treatment site.

13. A method for loading and unloading a catheter device having a full-length guidewire lumen over a conventional-length guidewire without the use of an exchange guidewire or a guidewire extension, the catheter device comprising an elongated shaft having a proximal end, a distal end, the shaft defining an inflation lumen and a guidewire lumen extending longitudinally throughout its length, and a hydraulic exchange lumen extending from the shaft proximal end and terminating at a position proximal the shaft distal end, the hydraulic exchange lumen being in fluid communication with the guidewire lumen, a balloon member coupled adjacent the distal end of the shaft, the balloon member defining an interior cavity in fluid communication with the inflation lumen, and a flow guiding member disposed within the guidewire lumen for redirecting the distal flow of pressurized fluid traveling through the hydraulic exchange lumen in a proximal direction through the guidewire lumen, the method comprising the steps of:

(a) inserting a guiding catheter in a patient'"'"'s vasculature;

(b) disposing an adapter at the proximal end of the guiding catheter at a position outside the patient;

(c) opening the adapter and inserting a conventional length guidewire having a distal end and a proximal end into the guiding catheter and advancing the distal end of the guidewire to a treatment site within the patient'"'"'s vasculature;

(d) maintaining the distal end of the guidewire across the treatment site and loading the distal end of the catheter guidewire lumen into the proximal end of the guidewire and advancing the catheter through the adapter into the guiding catheter;

(e) advancing the catheter over the guidewire until the distal end of the catheter is immediately proximal the adapter;

(f) injecting fluid into the proximal end of the hydraulic exchange lumen under constant and steady pressure, thereby advancing the catheter over the guidewire into the patient'"'"'s vasculature until the proximal end of the guidewire protrudes from the proximal end of the guidewire lumen;

(g) gripping the proximal end of the guidewire and grasping and pushing the catheter toward the adapter until the balloon member is positioned across the treatment site;

(h) gripping the proximal end of the guidewire lumen and grasping and withdrawing the catheter from the patient until the proximal end of the catheter is positioned within the proximal end of the guidewire lumen;

(i) injecting fluid into the proximal end of the guidewire lumen under constant and steady pressure, thereby withdrawing the catheter from the patient'"'"'s vasculature over the guidewire until the distal end of the catheter is immediately proximal the adapter;

(j) maintaining the position of the distal end of the guidewire across the treatment site and grasping and removing the catheter from the proximal end of the guidewire.