Universal catheter with interchangeable work element

• US 5,868,767 A
• Filed: 01/17/1997
• Issued: 02/09/1999
• 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: Farley, Brian, Schulz, Grace Yen, Hundertmark, Ron Ray
• Primary Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/784,403
• Time in Patent Office: 753 Days
• Field of Search: 606/1, 606/108, 606/59, 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 perfilsion 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 including a proximal end, a distal end having an inner surface, and a lumen extending therebetween; and

a housing including a hollow interior, a lateral portion having an aperture, and an open proximal end connected to the distal end of the catheter body, the open proximal end of the housing having an outer surface;

the lumen of the catheter body and the hollow interior of the housing establishing a receiving space, and

the inner surface of the distal end of the catheter body being disposed about the outer surface of the proximal end of the housing;

whereby a work element is insertable into the receiving space from the proximal end of the catheter body.

2. The intravascular catheter of claim 1, further comprising a slip ring disposed about the outer surface of the distal end of the catheter body.

3. The intravascular catheter of claim 1, further comprising a tubular adapter disposed about the outer surface of the distal end of the catheter body.

4. An intravascular catheter for use with interchangeable work elements, the catheter comprising:

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

a housing including an interior surface defining a hollow interior, a lateral portion having an aperture, and an open proximal end having a connection to the distal end of the catheter body, the connection defining a junctional region;

a work element disposed in the hollow interior of the housing proximate the aperture, the work element including a proximal end; and

a work element connector, disposed in the lumen of the catheter body, including a proximal end disposed through the proximal end of the catheter body and a distal end connected to the proximal end of the work element;

the catheter body lumen and the interior surface of the housing establishing a receiving space;

the catheter body lumen, the interior surface of the housing, and the work element being so configured that the receiving space is traversable by the work element from the proximal end of the catheter body at least to the aperture of the housing.

5. The intravascular catheter of claim 4 further comprising at least one perfusion port, proximate the junctional region, establishing a perfusion pathway from outside the intravascular catheter to the receiving space.

6. The intravascular catheter of claim 4 wherein the work element is chosen 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 abrasive ablation device, and an ultrasonic transducing device.

7. The intravascular catheter of claim 4 wherein the work element is a rotary atherectomy cutter and the work element connector is a drive cable.

8. The intravascular catheter of claim 4 further comprising a proximal assembly.

9. The intravascular catheter of claim 4 further comprising a hemostasis valve fluidly communicating with the catheter body lumen proximate the proximal end thereof.

10. The intravascular catheter of claim 5 wherein the perfusion port is a rectangular slot oriented circumferentially with respect to the catheter.

11. An intravascular catheter as set forth in claim 4, wherein the work element includes a proximal end and a periphery defining an outside diameter;

and

the catheter body lumen, the interior surface of the housing, and the work element are so configured that the receiving space has a diameter no less than the outside diameter of the work element periphery.

12. An intravascular catheter as set forth in claim 4, wherein the work element includes a proximal end and has a periphery defining cross sectional area;

and

the catheter body lumen, the interior surface of the housing, and the work element are so configured that the receiving space has a cross sectional area no less than the cross sectional area of the work element periphery.

13. An intravascular catheter as set forth in claim 4, wherein the hollow interior of the housing has a cross sectional area;

and

the catheter body lumen, the interior surface of the housing, and the work element are so configured that the receiving space has a cross sectional area no less than the cross sectional area of the housing interior.

14. An intravascular catheter for use with interchangeable work elements, the catheter comprising:

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

a housing including an interior surface defining a hollow interior, a lateral portion having an aperture, and an open proximal end having a connection to the distal end of the catheter body, the connection defining a junctional region;

a work element disposed in the hollow interior of the housing proximate the aperture, the work element including a proximal end; and

a work element connector, disposed in the lumen of the catheter body, including a proximal end disposed through the proximal end of the catheter body and a distal end connected to the proximal end of the work element;

the catheter body lumen and the interior surface of the housing establishing a receiving space;

the catheter body lumen, the interior surface of the housing, and the work element being so configured that the receiving space is traversable by the work element from the proximal end of the catheter body at least to the aperture of the housing;

the distal end of the catheter body having an inner surface;

the proximal end of the housing having an outer surface;

the inner surface of the distal end of the catheter body being disposed about the outer surface of the proximal end of the housing.

15. The intravascular catheter of claim 14 further comprising a slip ring disposed about the outer surface of the distal end of the catheter body.

16. The intravascular catheter of claim 14 further comprising a tubular adapter disposed about the outer surface of the distal end of the catheter body.

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

placing within a blood vessel lumen a catheter for use with interchangeable work elements, the catheter including;

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

a housing including an interior surface defining a hollow interior, a lateral portion having an aperture, and an open proximal end having a connection to the distal end of the catheter body, the connection defining a junctional region;

a work element disposed in the hollow interior of the housing proximate the aperture, the work element including a proximal end; and

a work element connector, disposed in the lumen of the catheter body, including a proximal end disposed through the proximal end of the catheter body and a distal end connected to the proximal end of the work element;

the catheter body lumen and the interior surface of the housing establishing a receiving space;

the catheter body lumen, the interior surface of the housing, and the work element being so configured that the receiving space is traversable by the work element from the proximal end of the catheter body at least to the aperture of the housing;

positioning the catheter body and work element so that the work element and the housing aperture are proximate a site of intervention; and

operating the working element.

18. The method of claim 17 wherein the step of placing the catheter within the blood vessel lumen further comprises the steps of:

selecting a work element;

inserting the work element into the receiving space via the proximal end of the catheter body; and

inserting the distal end of the catheter into and along the blood vessel lumen until the aperture of the housing is proximate a site of interest.

19. The method of claim 17 wherein the step of placing the catheter within the blood vessel lumen further comprises the steps of:

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

selecting a work element; and

inserting the work element into the receiving space via the proximal end of the catheter body.

20. The method of claim 17 further comprising the steps of:

after the step of placing the catheter in the blood vessel lumen,

selecting a second work element;

inserting the second work element into the receiving space via the

proximal end of the catheter body; and

operating the second work element.

21. The method of claim 20 further comprising the step of withdrawing a work element from the receiving space before operating the second work element.

22. The method of claim 17 wherein the work element comprises a rotary cutter including a cutting edge facing proximally, the method comprising the additional step of withdrawing the work element in a proximal direction,

whereby material is urged from the interior of the housing into the catheter body lumen.

23. The method of claim 17 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 abrasive ablation device, and an ultrasonic transducing device.

24. The method of claim 17 wherein the work element is selected from the group consisting of:

a drug delivery device, an aspirating device, and a hydraulic cutting/aspirating device.

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

placing within a blood vessel lumen a catheter for use with interchangeable work elements, the catheter including;

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

a housing including an interior surface defining a hollow interior, a lateral portion having an aperture, and an open proximal end having a connection to the distal end of the catheter body, the connection defining a junctional region;

a work element disposed in the hollow interior of the housing proximate the aperture, the work element including a proximal end; and

a work element connector, disposed in the lumen of the catheter body, including a proximal end disposed through the proximal end of the catheter body and a distal end connected to the proximal end of the work element;

the catheter body lumen and the interior surface of the housing establishing a receiving space;

the catheter body lumen, the interior surface of the housing, and the work element being so configured that the receiving space is traversable by the work element from the proximal end of the catheter body at least to the aperture of the housing;

the catheter further comprising at least one perfusion port, proximate the junctional region, establishing a perfusion pathway from outside the intravascular catheter to the receiving space proximal to the aperture of the housing;

positioning the catheter body and work element so that the work element and the housing aperture are proximate a site of intervention; and

operating the working element;

the method comprising the additional step of retracting the work element proximal to the perfusion port,

whereby blood is able to flow past the housing.

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

placing within a blood vessel lumen a catheter for use with interchangeable work elements, the catheter including;

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

a housing including an interior surface defining a hollow interior, a lateral portion having an aperture, and an open proximal end having a connection to the distal end of the catheter body, the connection defining a junctional region;

a work element disposed in the hollow interior of the housing proximate the aperture, the work element including a proximal end; and

a work element connector, disposed in the lumen of the catheter body, including a proximal end disposed through the proximal end of the catheter body and a distal end connected to the proximal end of the work element;

the catheter body lumen and the interior surface of the housing establishing a receiving space;

the catheter body lumen, the interior surface of the housing, and the work element being so configured that the receiving space is traversable by the work element from the proximal end of the catheter body at least to the aperture of the housing;

positioning the catheter body and work element so that the work element and the housing aperture are proximate a site of intervention; and

operating the working element,

the method further comprising the steps, after the step of placing the catheter in the blood vessel lumen, of

selecting a second work element;

inserting the second work element into the receiving space via the proximal end of the catheter body; and

operating the second work element,

the second work element being selected to perform a function different from that of the first work element.

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

inserting a guidewire within the blood vessel and advancing the guidewire to a position proximate a site of interest;

positioning the catheter within the blood vessel by sliding the catheter along the guidewire;

placing within a blood vessel lumen a catheter for use with interchangeable work elements, the catheter including;

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

a housing including an interior surface defining a hollow interior, a lateral portion having an aperture, and an open proximal end having a connection to the distal end of the catheter body, the connection defining a junctional region;

a work element disposed in the hollow interior of the housing proximate the aperture, the work element including a proximal end; and

a work element connector, disposed in the lumen of the catheter body, including a proximal end disposed through the proximal end of the catheter body and a distal end connected to the proximal end of the work element;

the catheter body lumen and the interior surface of the housing establishing a receiving space;

the catheter body lumen, the interior surface of the housing, and the work element being so configured that the receiving space is traversable by the work element from the proximal end of the catheter body at least to the aperture of the housing;

positioning the catheter body and work element so that the work element and the housing aperture are proximate a site of intervention; and

operating the working element.