Fluid-circulating catheters useable for endovascular heat exchange

• US 10,561,528 B2
• Filed: 12/30/2016
• Issued: 02/18/2020
• Est. Priority Date: 12/30/2016
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Inventors: Mazzone, James D, Mafi, Masoumeh, Lim, Alex L, Irwin, Jack I, Nguyen, Dung A
• Primary Examiner(s): Stoklosa, Joseph A
• Assistant Examiner(s): Avigan, Adam J
• Application Number:
  US15/395,858
• Publication Number:
  US 20180185192A1
• Time in Patent Office: 1,145 Days
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0043 characterised by structural features

Abstract

Disclosure includes fluid-circulating heat exchange catheters, systems and related methods useable for controlling a patient'"'"'s body temperature.

Claims

1. A catheter device comprising:

a catheter body having a distal end, a first lumen and a second lumen;

an elongate member which extends distally from the catheter body, said elongate member having a plurality of spaced-apart heat exchange member-receiving features therein or thereon;

at least one heat exchange member disposed on the elongate member and connected to said first and second lumens such that fluid may circulate in a distal direction through the first lumen, then through said at least one heat exchange member, then in a proximal direction through the second lumen;

a third lumen extending through the catheter body; and

an elongate luminal member attached to the catheter body and extending substantially parallel to the elongate member, said elongate luminal member which has a lumen extending longitudinally therethrough;

wherein portions of said at least one heat exchange member are captured between the elongate member and the elongate luminal member.

2. A catheter device according to claim 1 wherein said at least one heat exchange member comprises at least one tube configured in a series of loops.

3. A catheter device according to claim 2 wherein the loops are helical.

4. A catheter device according to claim 3 wherein helical loops of a first size are formed in a first tube or first tube segment helical loops of a second size are formed in a second tube or second tube segment.

5. A catheter device according to claim 1 wherein said at least one heat exchange member comprises a continuous tube having a first segment which runs from the catheter body to a distal location on the elongate member and a second segment that returns from the distal location on the elongate member to the catheter body.

6. A catheter device according to claim 1 wherein said at least one heat exchange member is selected from:

a single heat member having a first segment through which heat exchange fluid circulates in a distal direction and a second segment through which heat exchange fluid circulates in a proximal direction;

a plurality of heat exchange members including at least a first heat exchange member through which heat exchange fluid circulates in a distal direction and a second heat exchange member which is connected to the first heat exchange member such that fluid which has flowed in the distal direction through the first heat exchange member then flows in the proximal direction through the second heat exchange member.

7. A catheter device according to claim 6 wherein the at least one heat exchange member comprises a first heat exchange member through which heat exchange fluid circulates in a distal direction, a second heat exchange member through which heat exchange fluid circulates in a proximal direction and a fluidic connection between the first and second heat exchange members, and, wherein:

the fluidic connection comprises a recirculating distal tip on a distal end of the elongate member, wherein the first and second heat exchange members are connected to the recirculating distal tip such that fluid may flow from the first lumen of the catheter body, in a distal direction through the first heat exchange member, through the recirculating distal tip, in a proximal direction through the second heat exchange member and then into the second lumen of the catheter body.

8. A catheter device according to claim 1 wherein helical loops of a first size are formed in a first heat exchange member segment or first heat exchange member and helical loops of a second size are formed in a second heat exchange member segment or second heat exchange member.

9. A catheter device according to claim 1 wherein:

the elongate member has receiving features formed therein or thereon, said receiving features corresponding to the size and shape of elongate member-contacting locations on said at least one heat exchange member; and

the elongate member-contacting locations on said at least one heat exchange member are positioned in the receiving features.

10. A catheter device according to claim 9 wherein the receiving features are selected from:

clips, projections, prongs, depressions, indentations, locator markings, notches, grooves, troughs, apertures, bores, through holes and open areas formed in the elongate member within which said locations on said at least one heat exchange member is/are fully or partially positioned.

11. A catheter device according to claim 1 wherein said at least one heat exchange member has between 44 and 54 helical loops.

12. A catheter device comprising:

a catheter body having a distal end, a first lumen and a second lumen;

an elongate member which extends distally from the catheter body, said elongate member having a plurality of spaced-apart heat exchange member-receiving features therein or thereon;

at least one heat exchange member disposed on the elongate member and connected to said first and second lumens such that fluid may circulate in a distal direction through the first lumen, then through said at least one heat exchange member, then in a proximal direction through the second lumen;

a third lumen extending through the catheter body; and

an elongate luminal member attached to the catheter body and extending substantially parallel to the elongate member, said elongate luminal member having a lumen extending longitudinally therethrough;

wherein;

the elongate member comprises an elongate member having receiving features formed thereon or therein, said receiving features corresponding to the size and shape of elongate member-contacting locations on said at least one heat exchange member,

the elongate member-contacting locations on said at least one heat exchange member are positioned in the receiving features formed on or in the elongate member; and

the elongate luminal member is mounted on the elongate member so as to retain said at least one heat exchange member within the receiving features.

13. A catheter device according to claim 12 wherein:

a series of said receiving features are formed along the elongate member;

said at least one heat exchange member is formed in a series of loops,

elongate member-contacting locations on at least some of the loops are positioned in the receiving features; and

,

the elongate luminal member is mounted on the elongate member so as to retain said loops within the receiving features.

14. A catheter device according to claim 13 wherein said at least one heat exchange member is also adhered to the elongate member.

15. A catheter device according to claim 13 wherein helical loops are formed in said at least one heat exchange member and wherein the helical loops are arranged to alternate between loops of a first diameter and loops of a second diameter.

16. A catheter device according to claim 15 wherein the size and number of helical loops is such that the catheter is capable of delivering at least about 600 watts of cooling power when saline solution operated within a rigid 22 mm ID tube through which water at a temperature of 37 degrees C. is pumped at a rate of 2.5 liters per minute.

17. A catheter device comprising:

a catheter body having a distal end, a plurality of inflow lumens and a single outflow lumen;

an elongate member which extends distally from the catheter body, said elongate member having a plurality of spaced-apart heat exchange member-receiving features therein or thereon;

at least one heat exchange member disposed on the elongate member and connected to said plurality of inflow lumens and said single outflow lumen such that fluid may circulate in a distal direction through the plurality of inflow lumens, then through said at least one heat exchange member, then in a proximal direction through said single outflow lumen;

a through lumen extending through the catheter body; and

an elongate luminal member attached to the catheter body and extending substantially parallel to the elongate member, said elongate luminal member having a lumen extending longitudinally therethrough;

wherein portions of said at least one heat exchange member are captured between the elongate member and the elongate luminal member; and

a plurality of distal circulation tubes or tube segments, each of which is connected to an inflow lumen of the catheter body and a single proximal circulation tube or tube segment which is connected to the outflow lumen of the catheter body;

wherein fluid may be circulated in the distal direction through the plurality of inflow lumens, then in the distal direction through the plurality of distal circulation tubes or tube segments, then in the proximal direction through the single proximal circulation tube or tube segment and then in the proximal direction through the single outflow lumen of the catheter body.

18. A catheter device comprising:

a catheter body having a distal end, a single inflow lumen and a plurality of outflow lumens;

an elongate member which extends distally from the catheter body, said elongate member having a plurality of spaced-apart heat exchange member-receiving features therein or thereon;

at least one heat exchange member disposed on the elongate member and connected to said single inflow lumen and said plurality of outflow lumens such that fluid may circulate in a distal direction through the single inflow lumen, then through said at least one heat exchange member, then in a proximal direction, through the plurality of outflow lumens;

a through lumen extending through the catheter body; and

an elongate luminal member attached to the catheter body and extending substantially parallel to the elongate member, said elongate luminal member having a lumen extending longitudinally therethrough;

wherein portions of said at least one heat exchange member are captured between the elongate member and the elongate luminal member; and

wherein said heat exchange member comprises;

a single distal circulation tube or tube segment which is connected to the inflow lumen of the catheter body and a plurality of proximal circulation tubes or tube segments, each of which is connected to an outflow lumen of the catheter body;

wherein fluid may be circulated in the distal direction through the single inflow lumen, then in the distal direction through the single distal circulation tube or tube segment, then in the proximal direction through the plurality of proximal circulation tubes or tube segments and then in the proximal direction through the plurality of outflow lumens of the catheter body.

19. A catheter device comprising:

a catheter body having a distal end, a first lumen and a second lumen;

an elongate member attached to the catheter body and extending beyond the distal end of the catheter body;

at least one tube disposed on said elongate member and connected to said first and second lumens such that fluid may circulate in a distal direction through the first lumen, then through said at least one tube and then in a proximal direction through the second lumen; and

an elongate luminal member attached to the catheter body and extending substantially parallel to the elongate member, said elongate luminal member having a through lumen extending therethrough;

wherein the elongate member comprises tube-receiving features within which separate locations on said at least one tube are positioned, thereby causing said at least one tube to be disposed in a configuration on said elongate member; and

wherein the tube-receiving features have openings, the locations on said at least one tube are inserted through the openings and into the tube-receiving features and the elongate tubular member is affixed to the elongate member in a manner that retains said at least one tube within the tube receiving features.

20. A catheter device according to claim 19 wherein said configuration comprise a coiled or looped configuration.

21. A catheter device according to claim 19 wherein the tube-receiving features are selected from:

clips, projections, prongs, depressions, indentations, locator markings, notches, grooves, troughs, apertures, bores, through holes and open areas formed in the elongate member, within which the spaced-apart locations on said at least one tube are positioned.

22. A catheter device according to claim 19 wherein said at least one tube is coiled or looped such that the catheter is capable of delivering at least about 600 watts of cooling power when saline solution operated within a rigid 22 mm ID tube through which water at a temperature of 37 degrees C. is pumped at a rate of 2.5 liters per minute.