Adjustable treatment chamber catheter

• US 5,462,529 A
• Filed: 09/29/1993
• Issued: 10/31/1995
• Est. Priority Date: 09/29/1993
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: The Technology Development Company
• Inventors: Simpson, John B., Anderson, Scott C.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): VANOVER, PERRY
• Application Number:
  US08/128,948
• Time in Patent Office: 762 Days
• Field of Search: 604/101, 604/102, 604/96, 604/19, 604/22, 604/27, 604/43, 604/35, 604/49, 606/192, 606/194, 606/167, 606/170, 606/180
• US Class Current: 604/101.04
• 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. An adjustable treatment chamber 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 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, an adjustable length treatment chamber being defined within the conduit and between the seals

an intermediate coaxial catheter member located between the inner and the outer coaxial catheter members and having a distal end and a proximal end, the intermediate catheter member being slidable and rotatable with respect to the other catheter members; and

burden loosening means disposed near the distal end of the intermediate catheter member for sliding and axial rotation within the treatment chamber to loosen plaque burden deposited on the biological conduit,

whereby, when the adjustable treatment chamber catheter is inserted into the biological conduit and the catheter members are slid with respect to each other to extend the distal end of the inner catheter member beyond the distal end of the outer catheter member and to adjust the longitudinal separation between the sealing members to a predetermined distance, the sealing members then being expanded, the adjustable length treatment chamber is created within the conduit and between the seals.

2. The adjustable treatment chamber catheter of claim 1, further including infusion means for the infusion of a fluid into the treatment chamber, and aspiration means for the aspiration of a fluid and biological debris out of the treatment chamber.

3. The adjustable treatment chamber catheter of claim 2, wherein the defined treatment chamber has a distal end, and the infusion means includes means for infusion of the fluid from the distal end of the treatment chamber.

4. The adjustable treatment chamber catheter of claim 3, wherein the means for infusion from the distal end includes the expandable sealing member disposed on the inner catheter member having a proximal end and a distal end, and the inner catheter member having an infusion opening near the proximal end of said sealing member, the inner catheter member further having an infusion lumen extending from the proximal end of the inner catheter member to the infusion opening, whereby when a fluid is introduced at the proximal end of the infusion lumen, the fluid moves through the lumen toward the infusion opening, then through the opening and into the treatment chamber.

5. The adjustable treatment chamber catheter of claim 2, wherein the defined treatment chamber has a proximal end and wherein the aspiration means includes an aspiration opening near the proximal end of the treatment chamber for the aspiration of the fluid and the biological debris out of the treatment chamber.

6. The adjustable treatment chamber catheter of claim 5, wherein the outer catheter member includes an aspiration lumen extending from the proximal end of the outer catheter member to the aspiration opening into the treatment chamber, whereby when suction is applied at the proximal end of the aspiration lumen, fluid and biological debris are removed from the treatment chamber by passing through the aspiration opening then along the aspiration lumen toward the proximal end.

7. The adjustable treatment chamber catheter of claim 1, further including guiding means for guiding the adjustable treatment chamber catheter within the biological conduit.

8. The adjustable treatment chamber catheter of claim 7, wherein the guiding means includes the inner coaxial catheter member having an opening at the distal end and a lumen extending from the proximal end to the opening, and a guide wire passing through the lumen and extending through the opening at the distal end of the lumen, the guide wire being slidable within the lumen and through the opening.

9. The adjustable treatment chamber catheter of claim 1, further including means for contracting the sealing members, whereby when the sealing members are contracted, the device can be more easily inserted, removed, and adjusted within the biological conduit.

10. The adjustable treatment chamber catheter of claim 1, wherein the expandable sealing members each comprise an inflatable balloon, each inflatable balloon having an interior for receiving a fluid during expansion.

11. The adjustable treatment chamber catheter of claim 10, wherein the means for expanding the sealing members includes the inner and the outer coaxial catheter members each having an inflation lumen and an opening connecting the lumen with the interior of the corresponding balloon, the inflation lumen extending from the proximal end of the catheter member to the opening, whereby when the catheter device is placed within a biological conduit and a fluid is introduced at the proximal end of the inflation lumen, it will pass through the lumen and then through the opening and into the balloon, thereby expanding the balloon, urging the balloon against, and forming a seal with, the biological conduit.

12. A treatment chamber catheter for insertion into a biological conduit, comprising:

a first catheter member having proximal and distal ends and an outer surface, an inflatable sealing member being disposed on the outer surface at the distal end, and an inflation lumen having an opening for communication with the sealing member and extending from the proximal end to the opening;

a second catheter member having proximal and distal ends and an outer surface, a burden loosening member being disposed on the outer surface at the distal end, and an infusion lumen extending from the proximal to the distal end and loosely enclosing the first catheter member proximally of the distal sealing member and being adapted for axial rotation about the first catheter member; and

a third catheter member having proximal and distal ends and an outer surface, a proximal inflatable sealing member being disposed on the outer surface, an inflation lumen having an opening to the proximal inflatable sealing member and extending from the proximal end to the opening, and an aspiration lumen extending from the proximal end to the distal end and loosely enclosing the second catheter member proximally of the burden loosening members, a treatment chamber being defined within the conduit and between the expandable sealing members.

13. The treatment chamber catheter of claim 12, further including a separation being defined between the sealing members, the separation being adjustable by sliding the third catheter member with respect to the first catheter member, and an adjustable length treatment chamber being defined,

whereby when the treatment chamber catheter is inserted into the biological conduit, the separation between the inflatable sealing members then being adjusted by sliding the first and the third catheter members with respect to each other, the sealing members then being inflated, an adjustable length treatment chamber is created within the conduit and between the seals.

14. The treatment chamber catheter of claim 12, wherein the infusion lumen has a diameter and the first catheter member has a diameter and the diameter of the lumen exceeds the diameter of the catheter member by an amount sufficient to permit a fluid to pass through the lumen.

15. The treatment chamber catheter of claim 12, wherein the aspiration lumen has a diameter and the second catheter member has a diameter and the diameter of the lumen substantially exceeds the diameter of the second catheter member.

16. The treatment chamber catheter of claim 15 wherein the difference in diameters allows removal of fluid and biological debris from the treatment chamber through the aspiration lumen.

17. The treatment chamber catheter of claim 12 wherein the second catheter member and the infusion lumen share a common longitudinal axis and wherein the second catheter member is adapted for rapid rotation about the first catheter member.

18. The treatment chamber catheter of claim 14 wherein the second catheter member is adapted for rapid rotation about the first catheter member and the fluid passing through the infusion lumen.

19. A fluid sealed treatment chamber catheter device for insertion into a biological conduit and having a treatment chamber of adjustable length, the catheter device comprising:

distal sealing means for creating a distal fluid seal within the biological conduit, the distal sealing means being attached near a distal end of a first catheter member;

burden loosening means for the reduction of biological tissue at a treatment site, the burden loosening means being attached radially near a distal end of a second catheter member, the second catheter member including an infusion lumen, the lumen slidably and rotationally enclosing the first catheter member proximally to the distal sealing means; and

proximal sealing means for creating a proximal fluid seal within the biological conduit, the proximal sealing means being attached near a distal end of a third catheter member, the third catheter member including an aspiration lumen having a diameter substantially greater than a diameter of the second catheter member and enclosing the second catheter member proximally to the burden loosening means,

whereby, when the catheter device is inserted into a biological conduit, the distal sealing means being positioned distally to a treatment site, and the third catheter member being slid with respect to the first catheter member to locate the proximal sealing means proximally to the treatment site and at an adjustable distance from the distal sealing means, a fluid sealed treatment chamber of adjustable length is thereby created within the conduit and between the sealing means.

20. The catheter device of claim 19 wherein the proximal and distal sealing means are expandable balloons and the attached catheter members include inflation lumens for inflation of the balloons.

21. The catheter device of claim 19 wherein the burden loosening means comprises a flexible member being disposed on the second catheter member.