Devices and methods for controlling patient temperature
Inventors
Kulstad, Erik • Caherty, Hugh Patrick
Assignees
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Abstract
Relatively non-invasive devices and methods for heating or cooling a patient's body are disclosed. Devices and methods for treating ischemic conditions by inducing therapeutic hypothermia are disclosed. Devices and methods for inducing therapeutic hypothermia through esophageal cooling are disclosed. Devices and methods for operative temperature management are disclosed.
Core Innovation
The invention provides a relatively non-invasive patient temperature control approach that uses an esophageal heat transfer device and methods for heating and cooling. The device includes a heat transfer region capable of directly contacting esophageal epithelium upon placement within an esophagus, and it is configured to induce and maintain systemic therapeutic hypothermia for ischemic conditions and to provide operative temperature management by controlling patient temperature.
The core device architecture includes at least one lumen providing a fluid path for flow of a heat transfer medium, with a heat transfer medium input port connected to the lumen and positioned proximal to the heat transfer region. In certain embodiments, the device further includes an inflow lumen and an outflow lumen in a semi-rigid tube, with a heat transfer medium input port connected to the inflow lumen and a heat transfer medium output port connected to the outflow lumen, and a gastric tube as part of the esophageal heat transfer device.
The disclosed configuration also includes an embodiment where the heat transfer region directly contacts esophageal epithelium without including a balloon or partially inflatable lumen. Performance is described through controller/sensor-based temperature feedback and claims of unexpectedly superior cooling performance, including relatively higher cooling rates and cooling capacity associated with the esophageal cooling arrangement.
Claims Coverage
The partial content includes four independent claims directed to an esophageal heat transfer device for temperature control with an esophageal epithelium-contacting heat transfer region, lumen-based heat transfer medium flow, and a gastric tube. The inventive features are primarily differentiated by device lumen/port structure and by an exclusion of balloon or partially inflatable lumen in one independent claim.
Esophageal heat transfer region with proximal input port and gastric tube
An esophageal heat transfer device having a distal end for insertion into a patient; a heat transfer region directly contacting esophageal epithelium upon placement; at least one lumen providing a fluid path for flow of a heat transfer medium; a heat transfer medium input port proximal to the heat transfer region and connected to the at least one lumen; and a gastric tube.
One or more lumens with port connection and gastric tube
An esophageal heat transfer device having one or more lumens providing a fluid path for flow of a heat transfer medium; a heat transfer region capable of directly contacting esophageal epithelium upon insertion into a patient; one or more ports connected to at least one of the one or more lumens; and a gastric tube.
Semi-rigid tube with inflow/outflow lumens defining direct-contact heat transfer region and gastric tube
An esophageal heat transfer device having at least one semi-rigid tube with a wall that defines an inflow lumen and an outflow lumen configured to provide a fluid path for flow of a heat transfer medium; a heat transfer medium input port connected to the inflow lumen; a heat transfer medium output port connected to the outflow lumen; a distal end for insertion into a patient; a heat transfer region directly contacting esophageal epithelium where the heat transfer region comprises a portion of the wall of the at least one semi-rigid tube; and a gastric tube.
No balloon or partially inflatable lumen with nostril/mouth insertion, input port, and gastric tube
An esophageal heat transfer device having a distal end configured for insertion into a nostril or mouth of a patient; a heat transfer region capable of directly contacting esophageal epithelium of the patient where the heat transfer region does not include a balloon or partially inflatable lumen; an input port for receiving a heat transfer medium; and a gastric tube.
Across the independent claims, the claim coverage centers on an esophageal heat transfer device with a heat transfer region configured for direct contact with esophageal epithelium, a lumen-based heat transfer medium pathway with porting, and a gastric tube. Structural variations include single-lumen versus inflow/outflow lumen configurations and specification of the heat transfer region as a portion of a semi-rigid tube wall, and one independent claim further requires avoidance of a balloon or partially inflatable lumen.
Stated Advantages
Unexpectedly superior cooling performance, with relatively higher cooling rates and cooling capacity described in the partial content.
Documented Applications
Induction/maintenance of systemic therapeutic hypothermia for ischemic conditions including ischemia-reperfusion, myocardial infarction, stroke, TBI, ARDS, and cardiac arrest.
Operative temperature management including warming/maintenance near normothermia under OR-like ambient conditions.
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