Multiple lumen heat exchange catheters

• US 20020045925A1
• Filed: 02/06/2001
• Published: 04/18/2002
• Est. Priority Date: 08/24/1998
• Status: Active Grant

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Machold, Timothy R., Keller, Wade A.
• Granted Patent: US 6,610,083 B2
• Time in Patent Office: Days
• US Class Current: 607/106
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00095 high, i.e. heat conducting
• 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 2007/0086 with a thermostat
• CPC Class Codes: A61F 2007/0095 with a temperature indicator
• CPC Class Codes: A61F 2007/0096 with a thermometer
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/10 Cooling bags, e.g. ice-bags
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2206/10 : Flow characteristics
• CPC Class Codes: A61M 2230/50 : Temperature
• 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
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters

Abstract

Catheter devices and methods for intravascular heating and/or cooling of human or veterinary patients. The catheter devices generally comprise catheters having inflow and outflow lumens and at least one curvilinear balloon connected to the inflow and outflow lumens such that heat exchange fluid may be circulated through the balloon(s). The catheter is inserted into the vasculature and heated or cooled fluid is circulated through the balloon(s) to heat or cool blood flowing in heat-exchange proximity to the balloon(s), thereby effecting heating or cooling of all or a portion of the patient'"'"'s body.

Claims

1. A heat exchange catheter for heating or cooling at least a portion of the body of a human or animal patient, said heat exchange catheter comprising:

a catheter shaft having an inflow lumen and an outflow lumen extending longitudinally therethrough;

at least one heat exchange balloon element attached to the catheter shaft and fluidly connected to the inflow and outflow lumens such that heat exchange fluid may circulate in the inflow lumen, through the at least one balloon element and out of the outflow lumen;

the balloon element being insertable into the vasculature of the patent and having a curvilinear configuration when heat exchange fluid is being circulated therethrough.

2. A heat exchange catheter according to claim 1 wherein said at least one balloon element comprises a plurality of balloon elements and, when heat exchange fluid is being circulated therethrough, at least one of the balloon elements assumes a curvilinear configuration about a common central axis.

3. A heat exchange catheter according to claim 1 wherein the curvilinear configuration assumed by the balloon element when heat exchange fluid is being circulated therethrough comprises a generally helical configuration.

4. A heat exchange catheter according to claim 2 wherein the balloon elements are spaced apart when heat exchange fluid is being circulated therethrough sufficient to allow blood to flow between the balloon elements.

5. A heat exchange catheter according to claim 3 further comprising stand offs between the balloon elements to maintain spaces between the balloon elements when heat exchange fluid is being circulated therethrough.

6. A heat exchange catheter according to claim 2 wherein at least some of the balloon elements differ in size.

7. A heat exchange catheter according to claim 6 wherein at least one of the balloon elements is longer than another balloon element.

8. A heat exchange catheter according to claim 6 wherein at least one of the balloon elements is larger in diameter than another balloon element.

9. A heat exchange catheter according to claim 1 wherein the at least one balloon element is twisted about a central tube that has a lumen extending longitudinally therethrough

10. A heat exchange catheter according to claim 9 wherein the central tube has a proximal end and a distal end and at least one balloon element has a proximal end and a distal end, and wherein:

the lumen of the central tube is connected at its proximal end to the inflow lumen of the catheter shaft and at its distal end to the distal end of a balloon element, such that heat exchange fluid will flow through the inflow lumen, through the central tube and into that balloon element; and

,

the proximal end of that balloon element is connected to the outflow lumen of the catheter shaft such that heat exchange fluid will flow out of that balloon element and through the outflow lumen of the catheter shaft.

11. A heat exchange catheter according to claim 10 wherein:

a first plug member forms a substantially fluid tight seal of the central lumen around the catheter shaft; and

,

a second plug member is located in the outflow lumen distal of the first plug member and forms a substantially fluid tight seal between the outflow lumen and the central lumen.

12. A heat exchange catheter according to claim 11 further comprising a distal manifold fluidly connecting the central lumen to the distal portions of the balloon elements.

13. A heat exchange catheter according to claim 11 further comprising a proximal manifold fluidly connecting the proximal portions of the balloon elements to the outflow lumen.

14. A heat exchange catheter according to claim 9 wherein the central tube has a proximal end and a distal end and at least one balloon element has a proximal end and a distal end, and wherein:

the proximal end of a balloon element is connected to the intflow lumen of the catheter shaft such that heat exchange fluid will flow through the inflow lumen and into the proximal end of that balloon element; and

,

the lumen of the central tube is connected to the distal end of that balloon element and the proximal end of the central tube is connected to the outflow lumen of the catheter shaft such that heat exchange fluid will flow from the distal end of that balloon element into the lumen of the central tube, through the lumen of the central tube and into the outflow lumen of the catheter shaft.

15. A heat exchange catheter according to claim 3 wherein at least one balloon element, when in its generally helical configuration makes approximately 1 full rotation about a central axis per 2 to 4 inches of length.

16. A heat exchange catheter according to claim 1 wherein at least a portion of the catheter shaft is insulated.

17. A heat exchange catheter according to claim 1 having a guidewire lumen extending longitudinally through at least a portion of the catheter.

18. A heat exchange catheter according to claim 14 wherein the at least one balloon element is helically disposed about a central member, said central member being attached to and extending coaxially from the catheter shaft, and wherein the guidewire lumen extends through the catheter shaft and through the central member.