Devices, systems, and methods for modulating tissue temperature
Inventors
Chaparro, Rafael Eduardo • MacCarini, Paolo • Gonzalez, Luis Fernando • Pearce, Donald • Wyckoff, III, Edward Lysk • Enam, Syed Faaiz • Shen, Jikai • O'Raw, Aliesha • Yang, Rachel
Assignees
Publication Number
US-12279990-B2
Publication Date
2025-04-22
Expiration Date
2039-09-06
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Abstract
This present disclosure provides devices, systems, and methods relating to the modulation of tissue temperature. In particular, the present disclosure provides devices, systems, and methods for rapidly cooling or heating tissue in a subject as a therapeutic and/or prophylactic means for treating tissue that has been injured or damaged.
Core Innovation
The present disclosure describes devices, systems, and methods for modulating the temperature of tissue in a subject, particularly through direct and rapid heating or cooling as a therapeutic or prophylactic treatment of injured or damaged tissue. The disclosed device comprises a heat exchanger with a proximal and distal end, where the distal end features a plurality of fins, and at least one thermoelectric modulator, such as one or more Peltier cells, coupled to the proximal end of the heat exchanger. The device does not require fluid or gas exchange to modulate tissue temperature, overcoming limitations of existing technologies.
The need addressed by the invention arises from the limitations of current methods for hypothermia or hyperthermia therapy after injuries such as stroke, traumatic brain injury, and other ischemic or traumatic conditions, where current cooling or heating solutions lead to complications such as inefficient heat transfer, elevated intracranial pressure, infection risks, and challenges in selectively targeting tissue. The inability of traditional devices, particularly those relying on fluid or gas exchange, to efficiently, conveniently, and safely cool or heat the human brain or other tissues has hindered translation of promising hypothermia and hyperthermia treatments into wider clinical practice.
This innovation features a heat exchanger that may be configured as a heat pipe, with a plurality of specifically designed fins at the distal end that increase surface area for heat exchange. The fins and heat exchanger may also be rotatable. The thermoelectric modulator, optionally consisting of a plurality of Peltier cells, enables both rapid and precise modulation of tissue temperature, either cooling or heating, depending on the applied power. The system can be operated via insertion into a catheter and powered externally, with the ability to achieve clinically relevant temperature modulation rates, such as at least ±0.5° C./min, and includes heat dissipation elements to augment performance.
Claims Coverage
The patent presents five independent claims, each introducing main inventive features centered around a device and methods for tissue temperature modulation.
Device for tissue temperature modulation with perforated fins and thermoelectric modulator
A device comprising a heat exchanger with a proximal end and a distal end, where the distal end has a plurality of perforated fins, and at least one thermoelectric modulator is coupled to the proximal end of the heat exchanger. This arrangement enables modulation of tissue temperature without requiring fluid or gas exchange.
Method for modulating brain tissue temperature using device inserted into catheter
A method involving inserting the above-described device into a catheter that is positioned within a fluid-filled cavity adjacent to brain tissue, and then applying power to the device, thereby modulating the temperature of the brain tissue.
Device with motor-driven rotating heat exchanger for temperature modulation
A device including a heat exchanger with a proximal and distal end, at least one thermoelectric modulator coupled to the proximal end, and a motor functionally coupled to the thermoelectric modulator. The motor supplies power to the heat exchanger, causing it to rotate around its longitudinal axis, thus enabling improved temperature modulation.
Device with motor-driven Peltier cell movement for tissue temperature modulation
A device incorporating a heat exchanger (comprising a heat pipe), at least one thermoelectric modulator coupled to its proximal end, and a motor that supplies power to one or more Peltier cells to cause continuous back-and-forth rotation of the Peltier cells with respect to the longitudinal axis of the heat exchanger, thereby allowing precise temperature modulation.
Method for modulating tissue temperature with motor-driven Peltier device in catheter
A method comprising inserting a device—having a heat exchanger with a proximal and distal end, at least one thermoelectric modulator coupled to the proximal end, and a motor as described—into a catheter positioned within a fluid-filled cavity adjacent to brain tissue, and applying power to the device to modulate brain tissue temperature.
The independent claims define a set of devices and methods enabling efficient, rapid, and direct modulation of tissue temperature, primarily through integrated heat exchangers with fins, thermoelectric modulators, and motor-driven components to enhance heat transfer without fluid or gas exchange.
Stated Advantages
The devices enable rapid cooling or heating of tissue as a therapeutic or prophylactic means to treat injured or damaged tissue.
The system avoids the need for fluid or gas exchange, mitigating risks associated with increased intracranial pressure or infection.
The technology allows direct, efficient, convenient, and safe modulation of tissue temperature, overcoming limitations of existing indirect methods.
The apparatus permits precise temperature control, including rates of at least ±0.5° C./min, useful for clinically relevant hypothermia or hyperthermia.
Documented Applications
Treating traumatic brain injuries, stroke, status epilepticus, global ischemia (heart attack), and other traumatic bodily injuries by direct tissue cooling.
Treating brain tumors, cavernous malformations, brain metastasis, headaches, migraines, and joint stiffness through tissue heating.
Using heat therapy for increasing the extensibility of collagen tissues, decreasing joint stiffness, reducing pain, relieving muscle spasms, reducing inflammation, reducing edema, and increasing blood flow during the post-acute phase of healing.
Employing the device in solid organs such as liver, brain, or kidney, by inserting directly or via catheter to heat or cool the tissue.
Inserting the device into a fluid-filled cavity adjacent to target tissue and modulating the temperature of adjacent tissue for therapeutic purposes.
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