Disposable cassette for intravascular heat exchange catheter

• US 6,673,098 B1
• Filed: 05/02/2000
• Issued: 01/06/2004
• Est. Priority Date: 08/24/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Machold, Timothy R., Bloom, Nicole Denise, Alejandro, Jose, Oliver, Edward A., Scott, Dave J., Roth, Alex T.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/563,946
• Time in Patent Office: 1,344 Days
• Field of Search: 607/104-107, 607/96, 607/114, 417/477.1, 417/478, 417/490, 417/540
• US Class Current: 607/96
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• 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: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• 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 7/0085 Devices for generating hot or cold treatment fluids
• 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 2025/1072 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 2205/127 with provisions for heating or cooling
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: F28D 1/0341 with U-flow or serpentine-flow inside the conduits
• CPC Class Codes: F28D 2021/005 for medical applications heating or cooling appliances for medical treatment A61F7/00
• CPC Class Codes: F28F 3/12 Elements constructed in the shape of a hollow panel, e.g. with channels F28D1/02, F28D1/03 take precedence
• CPC Class Codes: F28F 9/0246 Arrangements for connecting header boxes with flow lines

Abstract

A heat exchange fluid supply system for supplying a heat exchange fluid to an intravascular heat exchange catheter includes a disposable cassette having a bulkhead and an external heat exchanger, and which is configured to operate in combination with a reusable master control unit. The bulkhead includes a reservoir section and a pump section. The reservoir section is provided with a means to monitor the amount of heat exchange fluid that is in the system. The bulkhead provides the mechanism for priming the system with heat exchange fluid from an external source and for circulating fluid to the catheter in a closed circuit. The pump section is configured to allow for pumping of heat exchange fluid at a constant pressure.

Claims

1. A heat exchange fluid supply system for a heat exchange catheter, said system comprising:

an external heat exchanger comprising a structural member and a compliant member, said compliant member sealed to said structural member in a pattern, said pattern forming a flow channel between said compliant member and said structural member, said flow channel having an inlet and an outlet;

a first fluid supply line, said first fluid supply line in fluid communication with said flow channel inlet;

a bulkhead, said bulkhead comprising a pump head and a reservoir, said reservoir having a reservoir inlet and a reservoir outlet, said reservoir inlet in fluid communication with said external heat exchanger flow channel outlet, said pump head having a pump inlet and a pump outlet, said pump inlet in fluid communication with said reservoir outlet for pumping fluid from said reservoir outlet;

a second fluid supply line, said second fluid supply line in fluid communication with said pump outlet for receiving fluid pumped out of said pump outlet; and

an external fluid source, said external fluid source in fluid communication with said bulkhead.

2. The system of claim 1 wherein said reservoir further comprises at least one fluid level detector.

3. The system of claim 2 wherein said fluid level detector comprises a least one prism mounted within the reservoir section, at least one optical beam source and at least one optical beam sensor, said source and sensor being mounted on a reusable master control unit adjacent to the prism.

4. The system of claim 2 wherein:

said bulkhead further comprises a chamber comprising a valve, a first chamber inlet in fluid communication with the external fluid source, a second chamber inlet in fluid communication with the reservoir outlet, and a chamber outlet in fluid communication with the pump inlet,

said valve having a first position whereby the first chamber inlet is open, the second chamber inlet is closed and fluid flows from the external fluid source to the pump inlet, and a second position whereby the first chamber inlet is closed, the second chamber inlet is open and fluid flows from the reservoir outlet to the pump inlet, and said fluid level detector is configured to detect a low fluid level and a high fluid level and said detector generates a first signal representing said low level and a second signal representing said high level; and

wherein initially the valve is in its first position and is maintained in said first position in response to said first signal thereby allowing fluid to enter said reservoir until it reaches said high level and said level detector generates said second signal, and said valve is actuated to its second position.

5. The system of claim 2 wherein said fluid level detector is configured to detect a low fluid level and generates a signal representing said low level, and said pump head is responsive to said signal such that said pump head stops pumping when said low level is detected.

6. The system of claim 1 further comprising a pressure regulator, said pressure regulator in fluid communication with said pump outlet for regulating the pressure of fluid pumped from said pump head.

7. The system of claim 1 wherein said first and said second fluid supply line are connected in a circuit through a heat exchange catheter.

8. The system of claim 2 wherein said at least one fluid level detector comprises:

a prism mounted in said reservoir, said prism having a diffraction surface;

a light source;

a light beam sensor; and

wherein said prism is configured so that when said light beam is directed against said diffraction surface when said diffraction surface is in contact with air, said light beam is reflected to impinge on said light beam sensor and said sensor generates a signal, and when said diffraction surface is in contact with fluid, said light beam does not reflect to said light beam sensor and said sensor does not generate a signal.

9. A disposable cassette for supplying a heat exchange fluid to a heat exchange catheter, said cassette comprising:

an external heat exchanger comprising a flow channel flow channel having an inlet and an outlet;

a first fluid supply line, said first fluid supply line in fluid communication with said flow channel inlet;

a bulkhead operably connected to the disposable fluid supply cassette, the bulkhead including a pump head, a pump inlet and a pump outlet, the pump inlet in fluid communication with the external heat exchanger flow channel outlet for pumping fluid from the flow channel outlet; and

a second fluid supply line, the second fluid supply line in fluid communication with the pump outlet for receiving fluid pumped out of the pump outlet.

10. The cassette of claim 9, wherein the pump head is a disposable pump head.

11. The cassette of claim 9, further comprising a pressure regulator in fluid communication the pump outlet for regulating the pressure of fluid pumped from the pump head.

12. The cassette of claim 11, wherein the pressure regulator is a regulator valve.

13. The cassette of claim 9, further comprising a reservoir, the reservoir having a reservoir inlet and a reservoir outlet, the reservoir inlet in fluid communication with the external heat exchanger flow channel outlet, the pump inlet in fluid communication with the reservoir outlet for pumping fluid from the reservoir outlet, and wherein the second fluid supply line is in fluid communication with the pump outlet for receiving fluid pumped out of the pump outlet.

14. The cassette of claim 9, further comprising an external fluid source in fluid communication with the bulkhead.

15. The cassette of claim 13, wherein the reservoir further comprises a fluid level detector.

16. The cassette of claim 15 wherein the fluid level detector comprises a prism mounted within the reservoir, an optical beam source and an optical beam sensor, the source and sensor being mounted adjacent to the prism.

17. The cassette of claim 15, wherein the bulkhead further comprises a chamber comprising a valve, a first chamber inlet in fluid communication with the external fluid source, a second chamber inlet in fluid communication with the reservoir outlet, and a chamber outlet in fluid communication with the pump inlet;

said valve having a first position whereby the first chamber inlet is open, the second chamber inlet is closed and fluid flows from an external fluid source to the pump inlet and a second position whereby the first chamber inlet is closed, the second chamber inlet is open and fluid flows from the reservoir outlet to the pump inlet, and the fluid level detector is configured to detect a low fluid level and a high fluid level and the detector generates a first signal representing the low level and a second signal representing the high level; and

wherein initially the valve is in its first position and is maintained in the first position in response to the first signal thereby allowing fluid to enter the reservoir until it reaches the high level and the level detector generates the second signal, and the valve is actuated to its second position.

18. The cassette of claim 9, wherein the pump head is a cardioid vane pump.

19. The cassette of claim 18, wherein the pump head comprises a rotor that is fitted with a vane for moving fluid from the pump, the rotor being positioned in a quasi-cardioid shaped cavity.

20. The cassette of claim 19 wherein:

(a) the cavity has a circumference, the rotor has a diameter “

D”

, and the vane has a length “

L”

;

(b) the cavity circumference comprises;

(i) a first arc defined as 330°

to 30° and

having a radius R1;

(ii) a second arc defined as 150°

o to 210° and

having a radius R2;

(iii) a third arc defined as 30°

o to 150° and

having a radius R3;

(iv) a fourth arc defined as 210°

to 330° and

having a radius R4;

(c) wherein all measurements are based upon the center of the rotor and 0°

is identified with the point midway between the inlet and the outlet of the cavity, and wherein the radii are defined as;

21. The cassette of claim 9 wherein said pump head is an impeller pump.

22. The cassette of claim 9 wherein the pump head is a gear pump.

23. The cassette of claim 9 wherein the bulkhead includes a pressure damper in fluid communication with the pump outlet.

24. A disposable cassette for supplying a heat exchange fluid to a heat exchange catheter, said cassette comprising:

an external heat exchanger comprising a flow channel having an inlet and an outlet;

a first fluid supply line, said first fluid supply line in fluid communication with said flow channel inlet;

a pump head contained in the disposable fluid supply cassette, said pump head having a pump inlet and a pump outlet, said pump inlet in fluid communication with said external heat exchanger flow channel outlet for pumping fluid from said flow channel outlet;

a second fluid supply line, said second fluid supply line in fluid communication with said pump outlet for receiving fluid pumped out of said pump outlet; and

a pressure regulator including a regulator valve and a pressure regulator chamber located adjacent a sensing chamber which communicates with the pressure regulator valve, said pressure regulator in fluid communication with said pump outlet for regulating the pressure of fluid pumped from said pump.

25. The cassette of claim 24 wherein said pressure regulator chamber comprises a counter spring and a counter spring block.

26. The cassette of claim 24 wherein said sensing chamber comprises a diaphragm and a push rod.