Adjustable treatment chamber catheter

• US 6,126,635 A
• Filed: 06/05/1995
• Issued: 10/03/2000
• Est. Priority Date: 09/29/1993
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Simpson, John B., Anderson, Scott C.
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Kline, Eric
• Application Number:
  US08/462,076
• Time in Patent Office: 1,947 Days
• Field of Search: 604/101, 604/102, 604/22, 604/27, 604/43, 604/35, 604/49, 606/170, 606/180
• US Class Current: 604/101.05
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/1011 Multiple balloon catheters

Abstract

Disclosed herein is a catheter device for treatment of disease in biological conduits. The device has inner and outer coaxial catheter members, each having an inflatable balloon attached near its distal end. When the balloons are inflated, a sealed treatment chamber is created between the balloons. The length of the treatment chamber is adjustable by sliding the coaxial catheter members with respect to each other to obtain a desired separation between the attached balloons before inflation. Biological debris is trapped within the chamber and removed by infusion and aspiration of a flushing fluid, reducing the risk of myocardial infarction. Adjunctive treatment devices can be inserted into the sealed treatment chamber through a lumen of the outer coaxial member.

Claims

1. A method for treating a diseased biological conduit, the method comprising the steps of:

providing a treatment chamber catheter of the type having concentric catheter members, two concentric members each having a distal end including an inflatable balloon for creating a sealed treatment chamber within the biological conduit and between the balloons, the length of the treatment chamber being adjustable by sliding the two concentric catheter members with respect to each other, the treatment chamber catheter also including an intermediate concentric catheter member having a distal end including burden loosening means, the treatment chamber catheter further including both infusion and aspiration means for removing biological debris and excess fluid from the treatment chamber, access to the sealed treatment chamber by adjunctive catheter-type treatment devices being through a lumen;

guiding the treatment chamber catheter into the biological conduit;

selecting a location of a treatment site;

positioning one inflatable sealing member within the conduit distally of the selected treatment site;

positioning the other inflatable sealing member within the conduit proximally to the selected treatment site;

adjusting the separation between the inflatable sealing members by sliding said members with respect to each other;

inflating the sealing members to create a sealed treatment chamber within the conduit and between the sealing members;

introducing a fluid into the chamber via the infusion means;

loosening friable tissue at the treatment site by operating the catheter member including the burden loosening means; and

removing biological debris and excess fluid from the sealed treatment chamber via the aspiration means.

2. The method as set forth in claim 1, further including the step of inserting a guiding catheter from a point of entry into the body to a region near the treatment site and continuing with the step of guiding the treatment chamber catheter through the guiding catheter and then into the biological conduit.

3. The method as set forth in claim 2, further including the point of entry being the groin, a distal end of the guiding catheter being advanced into the aorta, and the treatment site being located in a peripheral blood vessel of the heart.

4. The method as set forth in claim 1, further including a step, immediately following the step of loosening friable material at the treatment site, of operating the catheter member including the burden loosening means to reduce the size of the loosened biological material for stabilizing the treatment site.

5. The method as set forth in claim 4, further including the steps of inserting an adjunctive catheter device for treatment into the sealed treatment chamber through the access lumen and operating the inserted device within the sealed treatment chamber to provide a predetermined adjunctive treatment.

6. The method as set forth in claim 5, wherein the predetermined adjunctive treatment includes one or more of the following:

balloon angioplasty, rotational atherectomy, transluminal extraction, and directional atherectomy.

7. The method as set forth in claim 4, wherein the step of operating the catheter member including the burden loosening means includes the steps of rotating and reciprocally sliding the intermediate coaxial catheter member axially with respect to the inner coaxial catheter member.

8. The method as set forth in claim 1, wherein the selected treatment site is a saphenous vein graft.

9. A method for treating a diseased biological conduit, the method comprising the steps of:

providing a treatment chamber catheter of the type having concentric catheter members, two concentric members each having a distal end including an inflatable balloon for creating a sealed treatment chamber within the biological conduit and between the balloons, the length of the treatment chamber being adjustable by sliding the two concentric catheter members with respect to each other, the treatment chamber catheter also including an intermediate concentric catheter member having a distal end including burden loosening means, the treatment chamber catheter further including both infusion and aspiration means for removing biological debris and excess fluid from the treatment chamber, access to the sealed treatment chamber by adjunctive catheter-type treatment devices being through a lumen;

inserting the treatment chamber catheter into the body at an entry point and guiding the catheter through biological conduits toward a preselected treatment site;

establishing a sealed treatment chamber of appropriate length at the site by positioning one balloon distally and the other proximally of the site, then adjusting the distance between the balloons by sliding one balloon with respect to the other to define the length of the sealed chamber, and inflating the balloons to create a sealed chamber within a biological conduit and between the inflated balloons;

stabilizing the treatment site by operating the intermediate concentric catheter and burden loosening means to loosen friable biological material at the site, and to reduce the size of the loosened material and by flushing the loosened and reduced material from the sealed chamber via the infusion and aspiration means;

performing an adjunctive treatment at the site; and

removing the treatment chamber catheter from the body.

10. The treatment method as set forth in claim 9, wherein the adjunctive treatment includes introducing a medicating fluid into the sealed treatment chamber via the infusion means, confining the medicating fluid at the treatment site, and removing the fluid from the treatment chamber via the aspiration means.

11. The treatment method as set forth in claim 10, further including the steps of preventing the fluid from being diluted and carried away in the bloodstream by confining the medicating fluid within the fluid sealed treatment chamber.

12. The treatment method as set forth in claim 9, wherein the adjunctive treatment includes balloon angiolplasty, rotational atherectomy, transluminal extraction, and directional coronary atherectomy.

13. The treatment method as set forth in claim 9, further including the steps of repositioning the sealed treatment chamber to another treatment site by deflating the balloons, guiding the treatment chamber catheter to the other treatment site, and resuming with the step of establishing a sealed treatment chamber of appropriate length.

14. The treatment method as set forth in claim 9, further including the steps of preventing debris from entering the bloodstream and causing myocardial infarction by trapping the debris between the inflated balloons within the fluid sealed treatment chamber.

15. A method for treating a diseased biological conduit, the method comprising the steps of:

providing a treatment chamber catheter of the type having concentric catheter members, two concentric members each having a distal end including an inflatable balloon for creating a sealed treatment chamber within the biological conduit and between the balloons, the length of the treatment chamber being adjustable by sliding the two concentric catheter members with respect to each other, the treatment chamber catheter also including an intermediate concentric catheter member having a distal end including burden loosening means, the treatment chamber catheter further including both infusion and aspiration means for removing biological debris and excess fluid from the treatment chamber, access to the sealed treatment chamber by adjunctive catheter-type treatment devices being through a lumen;

inserting the treatment chamber catheter into the body at an entry point;

guiding the treatment chamber catheter from the entry point into a predetermined biological conduit;

selecting a specific location of the biological conduit as a treatment site;

positioning one inflatable sealing member within the conduit distally of the selected treatment site;

positioning the other inflatable sealing member within the conduit proximally of the selected treatment site;

adjusting the separation between the inflatable sealing members by sliding said members with respect to each other;

inflating the sealing members to create a sealed treatment chamber within the conduit and between the sealing members;

operating the catheter member including the burden loosening means to loosen friable material and to reduce its size;

introducing a predetermined fluid medication via the infusion means into the sealed treatment chamber; and

confining the medication at the treatment site within the sealed treatment chamber.

16. The treatment method as set forth in claim 15, further including the step of removing the confined medication and biological debris from the sealed treatment chamber via the aspiration means.

17. The treatment method as set forth in claim 16, wherein the provided treatment chamber catheter includes means for deflating the inflated sealing members, and further including the steps of deflating the inflatable sealing members and removing the treatment chamber catheter from the biological conduit.

18. The treatment method as set forth in claim 15, further including the step of inserting a guiding catheter from a point of entry into the body to a region near the treatment site and continuing with the step of guiding the treatment chamber catheter through the guiding catheter and then into the biological conduit.

19. A fluid sealed treatment chamber catheter for insertion into a biological conduit, and defining an adjustable length treatment chamber, comprising:

an inner coaxial catheter member having proximal and distal ends and including multiple lumens extending between the ends;

an outer coaxial catheter member having proximal and distal ends and including multiple lumens, the outer coaxial catheter member enclosing a portion of the inner coaxial catheter member, one lumen of the outer coaxial catheter member having a diameter and the inner coaxial catheter member having a diameter and said lumen having a diameter substantially larger than the diameter of the enclosed portion of inner coaxial catheter member;

a distal sealing member disposed near the distal end of the inner coaxial catheter member, the distal sealing member being inflatable and having an interior in fluid communication with a lumen of the inner catheter member, said lumen being sealed near the distal end of the inner coaxial catheter member permitting infusion of a fluid via said communicating lumen to inflate and aspiration of said fluid to deflate said distal sealing member;

a proximal sealing member disposed near the distal end of the outer coaxial catheter member, the proximal sealing member being inflatable and having an interior in fluid communication with a lumen of the outer catheter member, said lumen being sealed near the distal end of the outer coaxial catheter member permitting infusion of a fluid via said communicating lumen to inflate and aspiration of said fluid to deflate said proximal sealing member;

a guide wire located within a lumen and extending along a portion of, and being axially slidable with respect to the inner coaxial catheter member, the guide wire extending distally of the distal end of the inner coaxial member, said guide wire lumen forming a fluid seal with the guide wire at the distal end to the inner coaxial catheter member, the guide wire being slidable within said fluid seal, said lumen including an opening located near a proximal end of the distal sealing member; and

a catheter member extending through a lumen of the outer coaxial catheter member from the proximal end to a location between the sealing members, said catheter member being rotatable and axially slidable with respect to the outer catheter member and having burden loosening members disposed near its distal end and adapted for loosening friable material.

20. The fluid sealed treatment chamber as set forth in claim 19, further including perfusion means for allowing a biological fluid to bypass the sealed treatment chamber.

21. An adjustable treatment catheter for insertion into a biological conduit, comprising:

inner and outer coaxial catheter members, both members having a distal end and a proximal end and being independently slidable with respect to each other;

two expandable sealing members, one sealing member being disposed near the distal end of each catheter member;

means for expanding the sealing members to form a pair of seals with the biological conduit, and adjustable length treatment chamber being defined within the conduit and between the seals;

burden loosening means for loosening friable material, burden loosening means positioned within the sealed treatment chamber; and

perfusion means for bypassing a fluid within the biological conduit around the sealed treatment chamber.