Rapid exchange catheter

• US 5,387,226 A
• Filed: 01/14/1994
• Issued: 02/07/1995
• Est. Priority Date: 01/14/1994
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Baxter International Inc.
• Inventors: Miraki, Manouchehr
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/181,686
• Time in Patent Office: 389 Days
• Field of Search: 606/191, 606/192, 606/194, 604/95-104
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon dilatation catheter of the mono-rail type includes a distal mono-rail section traversing a dilatation balloon of the catheter, and a sheath member slidably movable axially of the remainder of the catheter and having a sheath section receiving an axial portion of the guide wire to in a first position effectively increase the mono-rail length of the catheter, and in a second position reduce the mono-rail length of the catheter to the length of the mono-rail section.

Claims

1. An elongate balloon dilatation catheter comprising:

a shaft portion having a proximal end and a distal end;

a mono-rail guide section adjacent said distal end of said shaft portion, said mono-rail guide section including an axial passage communicating with a guidewire port through which an elongate guide wire may pass to be exposed outwardly of said catheter proximally of said mono-rail guide section, said axial passage defining a mono-rail length for said catheter;

an expansible dilatation balloon positioned about said mono-rail guide section; and

a mono-rail sheath member slidably movable axially along said shaft portion proximal of said dilatation balloon, said sheath member comprising a proximal end, a distal end, and a guidewire port positioned between said proximal and distal ends;

wherein said sheath member is slidably movable along said shaft portion between a first position sheathing the guide wire proximally of said mono-rail guide section and cooperating therewith to effectively increase the mono-rail length of the catheter and a second position in which said sheath member port is aligned with said guidewire port of said shaft portion to allow the guidewire to be exposed outwardly of said catheter and said sheath member proximally of said aligned ports.

2. The dilatation catheter of claim 1 wherein said mono-rail sheath member is tubular in configuration.

3. The dilatation catheter of claim 2 wherein said sheath member includes a distal section of comparatively larger inner diameter opening at said distal end to receive in said first position of said sheath member both said catheter shaft and said guide wire in said distal section proximally of said axial passage.

4. The dilatation balloon of claim 3 wherein said sheath member distal section is receivable over a portion of said mono-rail length defined by said axial passage in said second position of said sheath member to substantially align said sheath member port with a proximal end of said axial passage and expose said guide wire outwardly of said catheter and proximally of said sheath member port.

5. The dilatation balloon of claim 4 wherein said sheath member includes a proximal section of comparatively smaller diameter which is slidably received on said catheter shaft portion.

6. The dilatation catheter of claim 1 wherein said catheter shaft portion comprises a proximal section of flexible metallic tubing.

7. The dilatation catheter of claim 6 wherein said catheter shaft portion also includes a distal section of polymeric tubing which is more flexible than said metallic tubing.

8. The dilatation catheter of claim 7 wherein said proximal metallic shaft section and said polymeric distal shaft section cooperatively define a butt joint therebetween.

9. The dilatation catheter of claim 1 wherein said sheath member in said second position thereof is slidably received over a portion of said monorail length of said catheter.

10. The dilatation catheter of claim 1, wherein said mono-rail length of the catheter is substantially defined only by said mono-rail guide section when said sheath member is in said second position.

11. A medical treatment catheter comprising:

an elongate shaft portion, said elongate shaft portion including a proximal section of metallic tubing which at a proximal end thereof includes means for receiving pressurized inflation fluid, said proximal metallic shaft section at a distal end thereof joining in end-to-end fluid-communicating relation with a distal section of flexible polymeric tubing, said distal section adjacent to a distal end thereof sealingly joining in fluid communication with a dilatation balloon at a proximal bond for said balloon, said dilatation balloon at a distal bond thereof sealingly joining with a tubular member opening distally and extending proximally within both said balloon and a distal portion of said distal polymeric section to at a proximal end thereof sealingly join with said polymeric distal section and to open outwardly thereon to define a guide wire port angulated toward said proximal section of said catheter, said tubular member between said guide wire port and said distal opening thereof defining a mono-rail length for said catheter within which a guide wire may be sheathed; and

a tubular sheath member slidably received axially over said proximal and distal sections and including a distal sheath section receiving therein said guide wire and defining a guide wire port spaced from a distal end of said sheath member and out of which said guide wire passes to be exposed proximally of said sheath member distal section, whereby in a first use position of said sheath member with said distal sheath section disposed proximally of said tubular member guide wire port the mono-rail length of said catheter is effectively extended by the length of said distal sheath section, and in a second withdrawal position of said sheath member in which said sheath member port is aligned with said guide wire port of said elongate shaft portion to allow said guide wire to be exposed outwardly of said catheter and said sheath member proximally of said aligned ports.

12. The catheter of claim 11 further including a reference mark on said catheter shaft with which a distal end of said sheath member aligns in said second withdrawal position of said sheath member.

13. The catheter of claim 11 wherein said proximal metallic catheter section is formed of hypotube.

14. The catheter of claim 13 wherein said hypotube has an outer diameter of substantially 0.023 inches, and a wall thickness of substantially 0.0025 inches.

15. The dilatation catheter of claim 11, wherein said mono-rail length of said catheter is defined substantially entirely by said tubular member.

16. An elongate medical balloon dilatation catheter comprising an elongate shaft portion at a distal end portion carrying an expansible dilatation balloon and at a proximal portion including means for receiving and discharging pressurized inflation fluid communicating with said dilatation balloon to expand and contract the latter;

a tubular member within a distal section of said catheter traversing said dilatation balloon and opening both distally and proximally to slidably receive a guide wire therethrough, said tubular member defining a mono-rail length for said catheter, and a sheath member slidably received axially over said catheter shaft proximally of said balloon and including a distal section within which said guide wire is received, said sheath member including a port at a proximal end of said sheath member distal section through which said guide wire passes outwardly to be exposed outwardly of said catheter proximally of said tubular member and sheath member distal section.

17. The dilatation catheter of claim 16, wherein said catheter shaft portion comprises a guidewire port communicating with said tubular member, and wherein in said second position, said sheath member port is aligned with said guidewire port of said catheter shaft portion to allow the guidewire to be exposed outwardly of said catheter and said sheath member proximally of said aligned ports.

18. An elongate balloon dilatation catheter comprising:

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

a mono-rail guide section adjacent said distal end of said shaft portion, said mono-rail guide section including an axial passage through which an elongate guide wire may pass to be exposed outwardly of said catheter proximally of said mono-rail guide section, said axial passage defining a mono-rail length for said catheter;

an expansible dilatation balloon positioned about said mono-rail guide section; and

a sheath member slidably movable axially along said shaft portion proximal of said dilatation balloon, said sheath member comprising a proximal end, a distal end, and a guidewire port positioned between said proximal and distal ends;

wherein said sheath member is slidably movable axially along said shaft portion of said catheter between a first position sheathing the guide wire proximally of said distal mono-rail guide section and cooperating therewith to effectively increase the mono-rail length of the catheter and a second position in which the mono-rail length of the catheter is substantially defined only by said mono-rail guide section.

19. The dilatation catheter of claim 18, wherein said catheter shaft portion comprises a guidewire port communicating with said axial passage, and wherein in said second position, said sheath member port is aligned with said guidewire port of said shaft portion to allow the guidewire to be exposed outwardly of said catheter and said sheath member proximally of said aligned ports.

20. A method of exchanging catheters during a medical procedure, said method including the steps of:

(a) providing a first elongate catheter comprising a shaft portion, a distal mono-rail guide section defining a mono-rail length for said first catheter, and a guidewire port proximal to said mono-rail guide section;

(b) providing a tubular sheath member axially movable on said shaft portion of said first catheter and comprising a guidewire port;

(c) inserting said first catheter into a patient'"'"'s vessel;

(d) sliding said sheath member to a first position sheathing said guide wire proximally of said mono-rail guide section to effectively lengthen said mono-rail length of said first catheter;

(e) sliding said sheath member proximally along said shaft portion of said first catheter to a second position in which said sheath member port is aligned with said guidewire port of said shaft portion to allow said guidewire to be exposed outwardly of said first catheter and said sheath member proximally of said aligned ports;

(f) removing said first catheter from said patient vessel; and

(g) inserting a second elongate catheter into said patient vessel.