Universal catheter with interchangeable work element

• US 5,632,754 A
• Filed: 12/23/1994
• Issued: 05/27/1997
• Est. Priority Date: 12/23/1994
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Devices for Vascular Intervention, Inc.
• Inventors: Hundertmark, Ron R., Schulz, Grace Y., Farley, Brian
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/363,142
• Time in Patent Office: 886 Days
• Field of Search: 606/155, 606/170, 606/171, 606/180, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00464 for use with different instruments with hole for different instruments A61B2017/22072
• CPC Class Codes: A61B 2017/22075 with motorized advancing or retracting means
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

Disclosed herein is an intravascular universal catheter having interchangeable work elements and methods of use thereof. The catheter comprises a flexible catheter body having a distal end, a proximal end and a lumen extending between the ends. A housing having an open interior and an aperture on a lateral side is attached to the distal end of the catheter body by a coupling element. A work element is movably disposed within the housing and operative through the aperture. A work element connector is disposed in a lumen of the catheter body and has a distal end connected to the work element. At least the distal portion of the lumen defines a receiving space within the catheter body, and the coupling element is configured to allow retraction of the work element from the housing through the open proximal end into the receiving space. In a preferred embodiment, perfusion ports are disposed in the catheter body and the housing proximate to the junctional region of the catheter body with the housing. The perfusion ports are in communication with the lumen. The work element may be withdrawn from the housing proximal to the perfusion ports to allow blood to flow into the housing and bypass the work element for perfusion of tissue downstream. Preferably, the lumen is configured to allow the work element to be completely withdrawn from the catheter body, so as to permit interchange of various work elements.

Claims

1. An intravascular catheter for use with an interchangeable work element,

the catheter comprising:

a catheter body having a distal end, a proximal end and a lumen extending therebetween; and

a housing having a hollow interior, an aperture on a lateral side thereof and an open proximal end connected to the distal end of the catheter body, the connection defining a junctional region; and

the lumen of the catheter body and the hollow interior of the housing combining to create a receiving space;

a coupling element connecting the distal end of the catheter body and the proximal end of the housing, the coupling element comprising a tubular adapter surrounding the distal end of the catheter body and the proximal end of the housing,

whereby, a work element may be inserted into the receiving space from the proximal end of the catheter body.

2. An intravascular catheter as set forth in claim 1, the catheter further comprising a work element disposed within the housing and attached to a work element connector disposed through the lumen of the catheter body, the work element connector having a distal end connected to the work element and a proximal end proximate to the proximal end of the catheter body.

3. An intravascular catheter as set forth in claim 2, wherein the work element is selected from the group consisting of a cutting device, an angioplasty balloon, an imaging device, a combined cutting and imaging device, a laser atherectomy device, a thermal ablation device, an electrosurgical device, an abrasive ablation device, and an ultrasonic transducing device.

4. An intravascular catheter as set forth in claim 2, wherein the work element is a rotary atheroma cutter with a cutting edge and the work element connector is a drive cable.

5. An intravascular catheter as set forth in claim 2, wherein the catheter contains at least one perfusion port proximate to the junctional region, and wherein the work element is retractable proximal to the perfusion port.

6. An intravascular catheter as set forth in claim 2, further comprising a proximal assembly connected to the proximal end of the catheter body.

7. An intravascular catheter as set forth in claim 6, wherein the proximal end includes a hemostasis valve for preventing backbleeding and introduction of air when the work elements are exchanged, inserted or withdrawn.

8. An intravascular catheter as set forth in claim 6, wherein the work element is an atheroma cutting device and the work element connector is a drive cable.

9. An intravascular catheter as set forth in claim 1 wherein the coupling element comprises a flared distal end of the catheter body.

10. A method of surgically intervening within a blood vessel lumen, the method comprising the steps of:

providing a universal catheter that includes;

a catheter body having a distal end, a proximal end and a lumen extending therebetween,

a housing having a hollow interior, an aperture on a lateral side thereof, and an open proximal end connected to the distal end of the catheter body, the connection defining a junctional region,

a perfusion port proximate to the junctional region and

the lumen of the catheter body and the hollow interior of the housing combining to create a receiving space for a work element;

selecting a first work element;

inserting the first work element into the receiving space from the proximal end of the catheter body;

inserting the universal catheter from its distal end into and along the blood vessel lumen until the aperture of the housing is opposing a site of interest; and

retracting the first work element proximal to the perfusion port whereby blood is able to flow past the catheter

operating the first work element.

11. The method of surgically intervening within a blood vessel as set forth in claim 10, wherein insertion of the catheter within the blood vessel lumen is preceded by insertion of a guidewire within the blood vessel lumen proximate to the site of interest, and wherein the catheter is positioned within the blood vessel by sliding the catheter distally along the guidewire with the guidewire passing through the lumen of the catheter body.

12. The method of surgically intervening within a blood vessel as set forth in claim 10, wherein the universal catheter further includes a perfusion port proximate to the junctional region and the method further comprises positioning the first work element proximal to the perfusion port whereby blood is able to flow past the catheter.

13. The method of surgically intervening within a blood vessel as set forth in claim 12, further comprising the steps of selecting a second work element, inserting the second work element in the proximal end of the catheter body, positioning the second work element within the housing, and operating the second work element.

14. The method of surgically intervening within a blood vessel as set forth in claim 10, further comprising removal of the first work element from the proximal end of the catheter body while the catheter body and housing remain in place within the blood vessel.

15. A method of surgically intervening within a blood vessel as set forth in claim 14, wherein the second work element is selected to perform a function different from that of the first work element.

16. A method of surgically intervening within a blood vessel lumen, the method comprising the steps of:

providing a universal catheter including

a catheter body having a distal end, a proximal end and a lumen extending therebetween,

a housing having a hollow interior, an aperture on a lateral side thereof, and an open proximal end connected to the distal end of the catheter body, the connection defining a junctional region, and

a drive cable disposed through the catheter body lumen and extending beyond the distal end of the catheter body into the hollow interior of the housing, and

a rotary atheroma cutter with a cutting edge, the cutter being disposed within the housing and attached to the drive cable, and the cutter oriented such that the cutting edge faces the drive cable;

inserting the universal catheter from its distal end into and along the blood vessel lumen until the aperture of the housing is opposing a site with stenotic material on an interior wall of the blood vessel;

axially translating the cutter past the housing aperture and toward the catheter body, severing the stenotic material thereby and;

removing the cutter from the proximal end of the catheter body while the catheter body and housing remain in place within the blood lumen.

17. The method of surgically intervening within a blood vessel as set forth in claim 16, further comprising the steps of selecting a second work element, inserting the second work element in the proximal end of the catheter body, positioning the second work element within the housing, and operating the second work element.

18. A method of surgically intervening within a blood vessel lumen, the method comprising the steps of:

providing a universal catheter including;

a catheter body having a distal end, a proximal end and a lumen extending therebetween,

a housing having a hollow interior, an aperture on a lateral side thereof, and an open proximal end connected to the distal end of the catheter body, the connection defining a junctional region, and

the lumen of the catheter body and the hollow interior of the housing combining to create a receiving space for a work element;

selecting a first work element;

inserting the first work element into the receiving space from the proximal end of the catheter body;

removing the first work element from the proximal end of the catheter body while the catheter body and housing remain in place within the blood vessel

selecting a second work element

inserting the universal catheter from its distal end into and along the blood vessel lumen until the aperture of the housing is opposing a site of interest; and

operating either the first or the second work element as appropriate.

19. The method of surgically intervening within a blood vessel as set forth in claim 18, wherein insertion of the catheter within the blood vessel is preceded by insertion of a guidewire within the blood vessel proximate to the site of interest, and wherein the catheter is positioned within the blood vessel by sliding the catheter distally along the guidewire with the guidewire passing through the lumen of the catheter body.

20. A method of surgically intervening within a blood vessel as set forth in claim 18, wherein the first work element is selected from the group which additionally includes a drug delivery device, an aspirating device and hydraulic cutting/aspirating device.

21. The method of surgically intervening within a blood vessel as set forth in claim 20, further comprising removal of the first work element from the proximal end of the catheter body while the catheter body and housing remain in place within the blood vessel.

22. A method of surgically intervening within a blood vessel as set forth in claim 18, wherein the first work element is selected from the group consisting of a cutting device, an angioplasty balloon, an imaging device, a combined cutting and imaging device, a laser atherectomy device, a thermal ablation device, an electrosurgical device, an abrasive ablation device, and a ultrasonic transducing device.

23. The method of surgically intervening within a blood vessel as set forth in claim 22, further comprising the steps of selecting a second work element, inserting the second work element in the proximal end of the catheter body, positioning the second work element within the housing, and operating the second work element.

24. The method of surgically intervening within a blood vessel lumen as set forth in claim 23, wherein insertion of the universal catheter within the blood vessel lumen is preceded by insertion of a guidewire within the blood vessel lumen proximate to the stenotic material, and wherein the universal catheter is positioned within the blood vessel lumen by sliding the catheter distally along the guidewire with the guidewire passing through the lumen of the catheter body.

25. The method of surgically intervening within a blood vessel as set forth in claim 18, wherein the universal catheter further includes a perfusion port proximate to the junctional region and wherein the method further comprises positioning the first work element proximal to the perfusion port whereby blood is able to flow past the catheter.

26. The method of surgically intervening within a blood vessel as set forth in claim 25, wherein the second work element is selected to perform a function different from that of the first work element.