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EP-4735809-A1 - CONTROL SYSTEMS AND METHODS OF HEAT EXCHANGE

EP4735809A1EP 4735809 A1EP4735809 A1EP 4735809A1EP-4735809-A1

Abstract

Heating and cooling modules and related control systems configured for control of the temperature of a heat-exchange material are described. For example, heating and cooling modules as described herein may be used in various medical systems involving temperature regulation and heat exchange, including, for example, extracorporeal membrane oxygenation (ECMO) systems and related fluid handling systems such as heart-lung machines and related systems which may be used in cardiopulmonary bypass applications.

Inventors

  • ANDERSON, Bradford, James
  • SOUSSE, Linda, Elias
  • DELLAVOLPE, Jeffrey, David
  • DAY, Jonathan, William
  • BELTRAN, JOSHUA

Assignees

  • INSTITUTE OF ECMO DEVELOPMENT, LLC

Dates

Publication Date
20260506
Application Date
20240628

Claims (20)

  1. 1. A heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray configured for positioning in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element when the temperatureexchange tray is mounted in the heating and cooling module; and a disposable conduit configured for mounting within said temperature-exchange tray.
  2. 2. The heating and cooling module of claim 1 wherein the thermoelectric semiconductor unit comprises a semiconductor array disposed between a first plate and a second plate and further comprising; a voltage source configured for applying a voltage across the semiconductor array so as to cool a working fluid circulated through said disposable conduit; a polarity of the voltage source being configured for adjustment so as to provide for alternative heating or cooling of the working fluid.
  3. 3. The heating and cooling module of claim 1 the temperature-exchange tray being slidably mounted in the heating and cooling module so as to provide access for removing the disposable conduit.
  4. 4. The heating and cooling module of claim 1 the temperature-exchange tray being mounted to the thermoelectric semiconductor unit using one or more rails.
  5. 5. The heating and cooling module of claim 1 wherein the temperature-exchange tray is slidably mounted to the thermoelectric semiconductor unit.
  6. 6. The heating and cooling module of claim 1 further including: a pump including a disposable pump head mounted to a non-disposable pump body.
  7. 7. The heating and cooling module of claim 1 wherein the heating and cooling module is configured for portable applications.
  8. 8. A heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray being in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element; and a disposable conduit configured for mounting within said temperature-exchange tray; wherein the thermoelectric semiconductor unit comprises a semiconductor array configured for alternative heating or cooling of the temperature-exchange tray.
  9. 9. A heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray being in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element; and a disposable conduit configured for mounting within said temperature-exchange tray.
  10. 10. The heating and cooling module of claim 9, wherein the temperature-exchange tray is slidably mounted in the heating and cooling module so as to provide access for removing the disposable conduit.
  11. 11. The heating and cooling module of claim 10 wherein the temperature-exchange tray is mounted to the thermoelectric semiconductor unit using one or more rails.
  12. 12. An extracorporeal membrane oxygenation apparatus comprising: a heating and cooling module configured for temperature regulation of a working fluid circulated therein, the heating and cooling module comprising: a temperature-exchange tray, the temperature exchange tray being in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element; and a disposable conduit configured for mounting within a temperatureexchange tray.
  13. 13. The extracorporeal membrane oxygenation apparatus of claim 12 wherein the temperature-exchange tray is slidably mounted in the heating and cooling module so as to provide access for removing the disposable conduit.
  14. 14. The extracorporeal membrane oxygenation apparatus of claim 12 wherein the temperature-exchange tray is mounted to the thermoelectric semiconductor unit using one or more rails.
  15. 15. The extracorporeal membrane oxygenation apparatus of claim 12 wherein the temperature-exchange tray is slidably mounted to the thermoelectric semiconductor unit.
  16. 16. The extracorporeal membrane oxygenation apparatus of claim 12 further including: a pump including a disposable pump head mounted to a non-disposable pump body.
  17. 17. The extracorporeal membrane oxygenation apparatus of claim 12, wherein the apparatus is portable.
  18. 18. An extracorporeal fluid handling apparatus comprising: a control system comprising: a heating and cooling module including a temperature-exchange tray and a disposable conduit configured for mounting within said temperatureexchange tray, the heating and cooling module further including a thermoelectric semiconductor unit and at least one heating element; and a pump configured for applying fluid pressure for circulating a working fluid through said disposable conduit, the pump including a disposable pump head mounted to a non-disposable pump body; and a target device coupled to said control system, the target device including one or more conduits for routing said working fluid along a fluid pathway so as to position the working fluid in a heat exchange relationship with a fluid circulating therethrough.
  19. 19. The extracorporeal fluid handling apparatus of claim 18 wherein said target device comprises a blood oxygenator, a heart lung machine, or a blood purifier.
  20. 20. A temperature control system configured for controlling the temperature of a working fluid circulated through a heating and cooling module, the control system comprising: a temperature-exchange tray, the temperature exchange tray configured for positioning in a heat exchange relationship with each of a thermoelectric semiconductor unit and at least one heating element when the temperatureexchange tray is mounted in the heating and cooling module; and a first disposable conduit configured for mounting within said temperatureexchange tray; the temperature-exchange tray being slidably mounted in the heating and cooling module so as to provide access for removing the first disposable conduit.

Description

IN THE UNITED STATES RECEIVING OFFICE INTERNATIONAL PCT APPLICATION FOR PATENT TITLE: CONTROL SYSTEMS AND METHODS OF HEAT EXCHANGE Bradford James Anderson Citizenship: United States Linda Elias Sousse Citizenship: United States and Lebanon Jeffrey David DellaVolpe Citizenship: United States Jonathan William Day Citizenship: United States Joshua Beltran Citizenship: United States Attorney Docket No.: 16059.10 Applicant: Institute of ECMO Development, LLC CROSS REFERENCE TO RELATED APPLICATIONS [001] This application claims priority to US Provisional Patent Application No. 63/524,532 titled “Control Systems and Methods of Heat Exchange” filed June 30, 2023. The full disclosure of the aforementioned patent application is herein fully incorporated by reference. FIELD [002] This disclosure relates to heating and cooling modules and to the use of heating and cooling modules and related control systems for use in medical applications involving heat exchange, including, for example, extracorporeal fluid handling systems. BACKGROUND [003] Extracorporeal fluid handling systems, such as blood oxygenators, commonly include or are used with a heat exchange system. The heat exchange system may, for example, be used to regulate the temperature of extracorporeally circulated blood to a clinically mandated temperature prior to entering or re-entering a patient’s body. A heating and cooling module and associated control system may be used to control the temperature of a heatexchange fluid that is routed through the heat exchange system so that the heat-exchange fluid may add or remove an appropriate amount of heat from the patient’s blood so as to control blood temperature. [004] Proper regulation of blood temperature may, for example, reduce risk of hypothermic sequela, including electrolyte imbalances, hemodynamic instability, bradycardia, or other conditions. Unfortunately, current heating and cooling systems in clinical use are generally cumbersome, heavy (—50 lbs), require large amounts of power, and require a relatively large amount of working fluid, such as water, during operation. These systems generally require plug-in accessibility to an electrical grid (AC power) and are ill suited for use in portable applications. Moreover, such systems typically operate with one or more open working fluid tanks that are not isolated from the outside environment and which require routine disinfection and cleaning. [005] There is a need for improved heating and cooling modules and related temperature control systems for use in extracorporeal fluid handling systems, including, for example, those used in portable applications. There is also a need for improved heating and cooling modules and related control systems configured to minimize risk of contamination of surrounding environments and/or target fluids heated or cooled thereby. There is also a need for improved heating and cooling modules and related temperature control systems configured for ease of replacement of disposable system components. SUMMARY [006] Systems described herein may be directed towards solving the aforementioned problems or other problems. For example, in some embodiments, temperature control systems described herein may provide a sealed circulation system that is substantially isolated from the outside environment during operation. For example, parts of the control system that come into working contact with working fluid (sometimes referred to herein as a heat exchange fluid) (e.g., water) may be disposable. Those parts may further be used in connection with nondisposable system parts. For example, some disposable conduits (e.g., working fluid conduit piping used for heat exchange) may be mounted in a non-disposable temperature-exchange tray. The disposable conduits may be configured for ease of replacement after one or more uses or between patients. The mechanism of mounting may further facilitate effective heat exchange between the disposable conduits and the temperature-exchange tray. [007] In some embodiments, a disposable pump head including a pump housing and a pump impeller may be disposed in a pathway of sealed fluid communication of a temperature control system. The pump head may be removably mounted to a pump body. When the pump head is engaged with the pump body, the pump impeller may be operatively engaged with a pump shaft and motor. In this configuration, a disposable pump head may be removed, and a new pump head installed and configured for use. [008] In some embodiments, a control system for regulating the temperature of a heatexchange fluid may be provided as a compact, portable system. The control system may be configured to operate for extended periods of time without access to electrical grid power (e.g., under battery- or solar- powered operation). In some embodiments, a portable control system may comprise a temperature-exchange tray for removable mounting of a disposable heatexchange conduit. The temperature-exchange tray may,