Disposable cassette for intravascular heat exchange catheter

• US 7,658,755 B2
• Filed: 07/25/2003
• Issued: 02/09/2010
• Est. Priority Date: 08/24/1998
• Status: Expired due to Fees

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Machold, Timothy R., Roth, Alex T., Bloom, Nicole Denise, Alejandro, Jose, Oliver, Edward A., Scott, Dave J.
• Primary Examiner(s): Nasser; Robert L
• Application Number:
  US10/627,487
• Publication Number:
  US 20050075705A1
• Time in Patent Office: 2,391 Days
• Field of Search: None
• 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 method for providing a temperature regulated source of heat exchange fluid for heat exchange catheters, comprising the steps of:

providing a disposable circuit assembly comprising an external heat exchanger, a heat exchange catheter, and a housing defining a pump section and a reservoir section, the housing having an air vent disposed in a wall of the housing defining the reservoir section, the pump section including a pump head, said external heat exchanger, pump head and reservoir and heat exchange catheter in fluid communication such that fluid pumped by the pump head of the bulkhead is circulated through said heat exchange catheter and said external heat exchanger, and said air vent allows passage of gas in and out of said disposable circuit assembly through said vent but does not allow passage of liquid in and out of said disposable circuit assembly through said air vent;

providing a heat generating or removing unit in heat exchange relationship with said external heat exchanger;

providing an external fluid source in fluid communication with said disposable circuit assembly;

providing a valve between said external fluid source and said disposable circuit assembly, said valve having an open position which permits the flow of heat exchange fluid from said external fluid source into said disposable circuit assembly and a closed position which prevents the flow of heat exchange fluid from said external fluid source to said disposable circuit assembly;

providing a level sensor within said disposable circuit assembly to sense when the fluid level in said disposable circuit assembly is full, said level sensor generating a signal in response to said full fluid level;

initially maintaining said valve in said open position until said sensor senses that the fluid level in said disposable circuit assembly is at an adequately full level; and

operating said valve into said closed position in response to said signal;

circulating heat exchange fluid from said external source through said disposable circuit assembly by means of pumping with said pump head while simultaneously venting any gas contained in said disposable circuit assembly out through said air vent; and

controlling the temperature of said heat exchanger fluid in said disposable circuit assembly by controlling the temperature of said heat generating or removing unit.

2. The method of claim 1 further comprising the step of controlling the pressure of said fluid as said fluid is circulated through said disposable circuit assembly.

3. The method of claim 2 wherein said pressure control comprises a pressure regulator in fluid communication with said disposable circuit assembly.

4. The method of claim 3 wherein said pressure regulator is a pressure damping mechanism.

5. The method of claim 2 wherein said pump head is operated by an electric motor, and said pressure is controlled by maintaining a predetermined current to said electric motor.