CN112566572A

CN112566572A - Systems and methods for thermal blockade of nerves

Info

Publication number: CN112566572A
Application number: CN201980054662.8A
Authority: CN
Inventors: S·波皮耶拉尔斯奇; C·泰; G·查普曼
Original assignee: Sermaquan Co ltd; University of Pittsburgh
Current assignee: Sermaquan Co ltd; University of Pittsburgh
Priority date: 2018-06-19
Filing date: 2019-06-19
Publication date: 2021-03-26
Also published as: EP3810003A1; AU2019288384A1; JP7513528B2; EP3810003A4; JP2021528151A; WO2019246318A1; CA3104484A1; AU2019288384B2

Abstract

The present disclosure relates generally to systems and methods for reversibly blocking nerves using thermal energy, including heating and cooling. The heating and/or cooling element may be implantable, while additional components of the system are provided outside the body. The system may also be fully implantable or completely external to the body.

Description

Systems and methods for thermal blockade of nerves

Cross Reference to Related Applications

This application claims priority from U.S. provisional patent application No.62/686,712 entitled "Devices, Uses and Methods for Reversible New Block at model Temperature" filed on 2018, 19/6, and the contents of which are incorporated herein by reference in their entirety.

This application is also incorporated by reference in its entirety into published PCT application No. PCT/US2016/064364 entitled "Device and Method for New Block by Local Cooling to Room Temperature", filed on 1/12/2016.

Statement regarding federally sponsored research or development

The invention was made with government support as granted by the national institutes of health, DK068566, DK094905, DK102427 and DK 111382. The government has certain rights in the invention.

Technical Field

The field of the invention is reversible neural blockade by thermal energy in human and animal subjects.

Drawings

The disclosure may be better understood with reference to the following drawings. The elements of the drawings are not necessarily to scale relative to each other, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, like reference numerals designate corresponding parts throughout the several views.

Fig. 1A-B are block diagrams illustrating an exemplary embodiment of a thermal energy system for reversible interruption of nerve conduction.

Fig. 2 is a block diagram illustrating another exemplary embodiment of a thermal energy system for reversible interruption of nerve conduction.

Figures 3A-C illustrate an exemplary thermal energy system for reversible blocking of nerve conduction.

Fig. 4 is a block diagram illustrating another exemplary embodiment of a thermal energy system for reversible interruption of nerve conduction.

Fig. 5A-B are images of another exemplary thermal energy system (such as that depicted in fig. 4) for reversible blocking of nerve conduction.

Fig. 6A-B depict exemplary effects of distance on a heated or cooled nerve or tissue temperature as may be provided by a thermal energy system.

Fig. 7 illustrates an exemplary insertion sheath, as may be used to assist in the implantation of components of a thermal energy system, such as the embodiment depicted in fig. 5A.

FIG. 8 is a rear perspective view of an exemplary fluidic neural interface that is not connected to a fluid tube.

Fig. 9 is a cross-sectional view of an embodiment of an exemplary fluidic neural interface around a nerve surrounded by a conductive gel (e.g., further surrounded by an insulator), such as depicted in fig. 8.

Fig. 10A-B are additional cross-sectional views of embodiments of an exemplary fluidic neural interface, such as that depicted in fig. 8.

Fig. 11 is a front perspective schematic view of an exemplary fluidic neural interface (such as that depicted in fig. 8) around a nerve, with a fluidic channel extending to the rear.

Fig. 12A-B are perspective views of an exemplary fluidic neural interface (such as that depicted in fig. 8) with a fluid tube attached (12A) or unattached (12B).

13A, 13B, and 13C are three portions of a flow chart depicting an exemplary method for applying the blocking aspect as described herein.

Detailed Description

The present invention relates to a series of methods and apparatus for thermally modulating nerves in the body of a human or other mammal. The invention is particularly useful for reversible blockade of chronic pain.

Embodiments of the present disclosure are illustrated by way of example in fig. 1-13. It should be noted that all terms used herein have the common meaning known in the art and are further described and discussed below. In this specification and in the claims which follow, reference will be made to a number of terms which shall be defined to have the following meanings:

as used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

As used herein, a range can be expressed as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, embodiments include from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It will be understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. It will also be understood that a number of values are disclosed herein, and that each value is also disclosed herein as "about" that particular value, in addition to the value itself. For example, if the value "50" is disclosed, then "about 50" is also disclosed.

As used herein, "moderate cooling" refers to cooling to a level below body temperature for a period of time in which any nerve damage that may occur is considered reversible. For example, moderate cooling includes cooling in a temperature range from about 15 ℃ to about 30 ℃.

As used herein, "mild heating" refers to heating to a level above body temperature for a period of time in which any nerve damage that may occur is considered reversible. For example, mild heating may include heating in a temperature range from about 42 ℃ to about 48 ℃ for a duration of no more than about 5-10 minutes.

As used herein, "reversible" refers to the ability of a nerve with a partial or complete block to restore most of the useful nerve function within a period of about one month after the treatment that caused the block. By this definition of "reversible", ablation is not considered reversible.

As used herein, the term "treatment" includes any desired effect on the symptoms or pathology of a disease or disorder, and may include even minimal reduction in one or more measurable markers of the disease or disorder being treated. "treating" does not necessarily indicate completely eradicating or curing the disease or disorder or symptoms associated therewith.

As used herein, the term "patient" or "subject" includes any mammal, including a human.

As used herein, the terms "transfer," "communication," or "connectivity" refer to the transfer, transmission, sending, and receiving of data, including signals, inputs, commands, and outputs. A device, component or system may communicate with another device, component or system, either directly, through a physical connection, or indirectly, such as through wireless transmission. The communicated data may be converted, translated, or otherwise processed between devices, components, or systems. The terms "transfer," "communication," or "communicating" may additionally refer to the transfer, circulation, or movement of a fluid from one or several devices, components, or systems to another or several other devices, components, or systems. Any electronic or fluid transfer means known in the art is contemplated.

As used herein, "blocking" of a nerve refers to the situation where a neuron does not propagate an action potential or has a reduced amplitude of evoked action potential. The blocking of the nerve may be partial, in which the neuron has a lower percentage of propagating action potentials than an unblocked neuron, or the amplitude of evoked action potentials is reduced relative to the amplitude of action potentials evoked by unblocked neurons.

As used herein, the "internal" position of a component, device or system is relative to the human body. For example, the internally located device may be located within the patient's body or under the patient's skin.

As used herein, the "external" position of a component, device or system is relative to the human body. For example, many externally located devices may be located outside or on the patient's body, but not inside or under the patient's skin.

In various aspects, provided herein are methods and devices for reversibly stimulating and/or blocking nerves via thermal modulation. Blocking nerves can be useful in treating a number of conditions, including but not limited to blocking and/or stimulating occipital nerves to treat occipital neuralgia, blocking and/or stimulating saprophythmic nerves for severe chronic knee pain following total knee replacement, blocking and/or stimulating the intra-articular region(s) of the knee to relieve pain associated with severe chronic pain in osteoarthritis, dorsal root ganglia, and other regions of the spinal cord, blocking and/or stimulating any region along the incision site to treat post-operative or post-operative pain around painful wounds, or blocking and/or stimulating the median nerve, the iliofencomeneal nerve, the tibial nerve, the sciatic nerve, the intercostal nerve, the peroneal nerve, the femoral nerve, the axillary nerve, the suprascapular nerve, the sural nerve, the ulnar nerve, the trabecular nerve, the lateral femoral cutaneous nerve, or any other pain-causing nerve. Other exemplary uses of the present methods and apparatus include treating obesity in a patient by blocking the abdominal branch of the vagus nerve, treating heart failure in a patient by blocking the sympathetic nerve and optionally one or more of the greater splanchnic nerves, lesser splanchnic nerves, or sympathetic trunk, treating urinary retention in a patient by blocking the pudendal nerve, treating muscle spasms in a patient by means of the nerves that innervate the muscles, treating cardiovascular disease in a patient by the vagus nerve, and treating occipital pain or migraine in a patient by means of the occipital nerve. The present methods and devices are contemplated for monitoring, diagnosing or treating any such condition or disease, where nerve block is appropriate for analyzing, identifying or managing the condition or disease or symptoms thereof.

In one embodiment, the thermal modulation is selected from heating only, cooling only, heating and cooling alternating or simultaneous heating and cooling of the nerve. Described herein are exemplary methods and apparatus of heating only, cooling only, and alternating heating and cooling.

In some embodiments, the reversible thermal interruption achieved by the present invention may be achieved by moderate heating followed by moderate cooling of a given portion of the nerve. It is well known that extreme heating or cooling of a nerve for a longer duration can result in irreversible damage to the nerve. For example, temperatures greater than or equal to about 50 ℃ and less than or equal to about 5 ℃ have been used in methods known in the art for single temperature nerve blocking. However, the application of these extreme temperatures to nerves can cause permanent damage within minutes or hours.

The initial heating step may allow for the application of a higher cooling temperature to produce a complete or partial nerve block than would otherwise be possible or acceptable without the initial heating step. By a combination of an initial mild heating and a subsequent mild cooling step, the present invention can avoid the use of extreme temperatures that can cause permanent damage. Blocking of a nerve includes situations where a neuron according to the methods or treatment with the present devices does not propagate an action potential, or where a lower percentage of neurons propagate an action potential than unblocked neurons.

The invention can affect nerves at safe temperatures, wherein at least partially irreversible nerve damage is avoided. The present invention can avoid these extreme and potentially damaging temperatures by first heating the nerve for a duration of time at a moderate temperature that is above body temperature but below a temperature that can cause irreversible damage to the nerve over a period of time. During mild heating, nerve conduction is partially or completely reduced and the nerve can be observed to have a partially or completely reduced evoked action potential or signal. After mild heating of the nerve, the nerve may be cooled for the duration of time at a mild temperature that is below body temperature but above a temperature that may cause irreversible damage to the nerve for a period of time. During moderate cooling, the temperature may be maintained at the cooling temperature or may be reduced by a series of steps that reduce the cooling temperature. The steps may have equal or unequal durations and may have equal or unequal temperature magnitudes. The transition between the heating and cooling phases may occur in less than about one minute, between about one minute and about three minutes, or between about three minutes and about five minutes. In one embodiment, the temperature transition between the heating and cooling phases occurs between about five minutes and about 25 minutes. In one embodiment, the temperature transition between the heating and cooling phases occurs between about 25 minutes and about 60 minutes.

In one embodiment, the cooling stage is in the range of about-5 ℃ to about 0 ℃. In one embodiment, the cooling stage is in the range of about 0 ℃ to about 15 ℃. In one embodiment, the cooling stage is in the range of about 15 ℃ to about 35 ℃. In one embodiment, the heating stage is in the range of about 40 ℃ to about 51 ℃. In one embodiment, the heating stage is in the range of about 43 ℃ to about 48 ℃.

In the embodiment depicted in fig. 1A-B, the thermal energy system (105, 305, 505) may be located externally with respect to the patient, implanted within the patient, or have components located internally or externally at or near the location of the nerves to perform thermal modulation. As shown in fig. 1A, the thermal energy system (105, 305, 505) may include a combination of internal and external components. In one embodiment, a combination of internal and external components may be used for heating, cooling, heating and cooling of the nerve alternately, or simultaneously. In one embodiment, a thermal energy system (105, 305, 505) as in fig. 1A may comprise a temperature controller (106, 306) comprising at least one heating element (108, 308, 515) and at least one cooling element (107, 307) implanted near a nerve, at least one feedback sensor (110, 310, 516), such as in one embodiment a temperature sensor capable of detecting temperature near at least one location, and an external system controller (109, 309, 510) connected to a power supply. The internal temperature controller (106, 306) may include at least one heating element (108, 308, 515), at least one cooling element (107, 307), and at least one feedback sensor (110, 310, 516), such as a temperature sensor in one embodiment, as shown in fig. 1A. In one embodiment, the system controller (109, 309, 510) may include a processor (111, 311, 522) and may be in communication with an internal temperature controller (106, 306), the internal temperature controller (106, 306) being capable of controlling the temperature of the at least one heating element (108, 308, 515) and the at least one cooling element (107, 307) and receiving information via signals from the at least one feedback sensor (110, 310, 516). The temperature may be adjusted by a system controller (109, 309, 510) based on signals it receives from at least one feedback sensor (110, 310, 516) comprising a temperature sensor.

In one embodiment, the at least one heating element (108, 308, 515) may be a resistive heating element, an inductive heating element, a Peltier heater, a microwave heating element, a radio frequency heating element, and an infrared emitter, or any other suitable heating means capable of providing the heating temperature and duration required in the mild heating step in the thermal modulation of the nerve. In one embodiment, the at least one cooling element (107, 307) may be a coolant tube, a thermoelectric cooler, a refrigeration system, a Peltier cooler, ice, or any other suitable cooling means capable of providing the cooling temperature and duration required in a moderate cooling step in the thermal modulation of the nerve. In one embodiment, the feedback sensor (110, 310, 516) is a thermocouple, thermistor, or any other suitable device or material capable of monitoring the temperature change of the nerve before, during, and after thermal modulation to block or partially block the nerve. The feedback sensor (110, 310, 516), such as a temperature sensor, may be placed in or near the at least one heating element (108, 308, 515) or the at least one cooling element (107, 307), or elsewhere in or on the body or within the device.

In one embodiment, the at least one heating element (108, 308, 515) may comprise a resistive heating element powered by inductive means. The resistive heating element may comprise a flexible portion comprising at least one resistive heating element powered by an induction coil receiving a radiated electromagnetic field, said flexible portion being connected to an internal control mechanism. The internal control mechanism may also include a temperature controller (106, 306) that may optionally be in wireless communication with the system controller (109, 309, 510). In different embodiments, the system controller (109, 309, 510) may be located internally or may be located externally.

In one embodiment, at least one feedback sensor (110, 310, 516), such as a temperature sensor capable of detecting temperature in one embodiment, is located in at least one location selected from: on or near the skin of the patient, on or near at least one heating element (108, 308, 515), in or near one or more cooling fluid channels, or in or near a thermoelectric cooler. In one embodiment, the thermal energy system (105, 305, 505) may include one or more feedback sensors (110, 310, 516) for monitoring various biomarkers or bio-signals to modify the thermal energy directed to the nerve. The system controller (109, 309, 510) may receive and process the biological signal of the subject from the at least one feedback sensor (110, 310, 516). In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, but the feedback sensor (110, 310, 516) may also monitor a biological signal selected from temperature and chemical levels on or near a nerve. In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, but the feedback sensor (110, 310, 516) may also monitor any other such useful and suitable parameter selected from body temperature, blood pressure, heart rate, time, sweat, blood oxygen saturation, electrocardiogram signals, and/or the patient's health, symptoms, or comfort. In one embodiment, there are a plurality of feedback sensors (110, 310, 516) whose output signals are received by the system controller (109, 309, 510) and/or a processor (111, 311, 522) of the system controller (109, 309, 510), which is configured with software to control the cooling elements (107, 307) and the heating elements (108, 308, 515). The thermal energy system (105, 305, 505) is configured to communicate the parameter detected by the feedback sensor (110, 310, 516) with a system controller (109, 309, 510). In one embodiment, the thermal energy system (105, 305, 505) may be configured by a clinician or user after implantation or external placement on a patient by means of selecting one or more parameters in software or firmware on a processor (111, 311, 522) of the system controller (109, 309, 510) or on the temperature controller (106, 306). In another embodiment, the parameters may be preset. In one embodiment, a user may control communication with a system controller (109, 309, 510), wherein the user may select an input factor from the group consisting of: pain level, range of motor functions, sensory sensitivities including pain touch, sharpness, temperature, and pressure level. The user may also control the system by turning "on" or "off, or by changing the operation at any level.

In one embodiment, the thermal energy system (105, 305, 505) may provide information to assist in acceptable placement of the thermal energy system (105, 305, 505). In one embodiment, the thermal energy system (105, 305, 505) may be configured to facilitate acceptable placement of the thermal energy system (105, 305, 505) after partially or completely blocking the nerve using a heating step followed by a cooling step. In this embodiment, the thermal energy system (105, 305, 505) may determine acceptable placement of the thermal energy system (105, 305, 505) based on an effect on the patient selected from the group consisting of sensation, body temperature, blood pressure, heart rate, time, sweat, oxygen saturation, electrocardiogram signals, temperature and chemical levels on or near nerves, or any other such useful and suitable parameter of the patient's health, symptoms or comfort. In one embodiment, the placement of the thermal energy system (105, 305, 505) may also be guided by user input factors selected from the group consisting of pain level, range of motor function, sensory sensitivity including pain touch, sharpness, temperature and pressure level. In one embodiment, the power delivered to the thermal energy system (105, 305, 505) may be controlled using a feedback loop based on the temperature detected by a feedback sensor (110, 310, 516), including but not limited to a temperature sensor.

The temperature controller (106, 306) may be physically or wirelessly connected to a system controller (109, 309, 510) comprising a processor (111, 311, 522) for controlling heating of the at least one heating element (108, 308, 515), cooling of the at least one cooling element (107, 307) and monitoring the temperature at the nerve. The means for wireless power transfer to the at least one heating element (108, 308, 515) may be inductive or microwave energy transfer.

In one embodiment, the thermal energy system (105, 305, 505) is powered by a power source, wherein the power source is selected from the group consisting of an internal primary battery, an internal (rechargeable) secondary battery, wireless power transfer including inductive power transfer, microwave power transfer, invisible laser power transfer, alternating current, and kinetic energy harvesting systems.

In one embodiment, as shown in fig. 2, the temperature controller (106, 306) may be connected to the patient through open skin, such as by using a percutaneous line and/or tube (312) or other such suitable connection means that controls the internal components of the temperature controller (106, 306). In this embodiment of the thermal energy system (105, 305, 505), the percutaneous line and/or tube (312) may be connected to at least one of the heating element (108, 308, 515) or the cooling element (107, 307) from an external system controller (109, 309, 510) comprising a processor (111, 311, 522), and the at least one feedback sensor (110, 310, 516) may be in communication with the processor (111, 311, 522). In one embodiment, the at least one heating element (108, 308, 515) and/or the at least one cooling element (107, 307) may be controlled by power received from the percutaneous line (312) to the power source.

In various embodiments, such as those depicted in fig. 1A-B, fluid transport may be utilized to transfer thermal energy of a thermal energy system (105, 305, 505) such that the heating and cooling temperatures indicated by the system controller (109, 309, 510) may be accurately achieved. In one embodiment, heat pipes are utilized to transfer thermal energy of a thermal energy system (105, 305, 505) such that the heating and cooling temperatures indicated by the system controller (109, 309, 510) can be accurately achieved. The heat pipe may be flexible and may be constructed of a biocompatible material.

In one embodiment, at least one of the at least one heating element (108, 308, 515) or the at least one cooling element (107, 307) may comprise a channel (113) for circulating a heated or cooled fluid. In one embodiment, a heated fluid reservoir (114) may be in communication with the channel (113) for circulating the heated fluid. In one embodiment, a cooled fluid reservoir (115) may be in communication with the channel (113) for circulating a cooled fluid. The heated fluid reservoir (114), the cooled fluid reservoir (115), or the recirculating fluid reservoir (512) may be capable of rapidly increasing or decreasing the temperature of the fluid within the reservoir so that the fluid can be circulated to provide heating and cooling of the nerve as directed by the system controller (109, 309, 510). Although fig. 1A shows a channel (113) for conveying cooled fluid to a cooled fluid reservoir (115) connected to at least one cooling element (107, 307), this is an exemplary embodiment and other channel configurations are possible, as described herein. For example, the channel (113) of fig. 1A may be connected to at least one heating element (108, 308, 515) to communicate heated fluid with a heated fluid reservoir (114). In one embodiment, as depicted in fig. 2, at least one heating element (108, 308, 515) is heated by a heated fluid and/or at least one cooling element (107, 307) is cooled by a cooled fluid, which is received through a bellows (312) from at least one fluid reservoir in fluid communication with at least one fluid pump controlled by an external system controller (109, 309, 510).

In one embodiment, a rapid increase or decrease in temperature of the fluid in the heated fluid reservoir (114) and/or the cooled fluid reservoir (115) may be performed using a thermal treatment device similar to that described in U.S. patent 9,283,109, which is incorporated herein by reference in its entirety. The apparatus may further comprise a heat exchanger for heating and/or cooling the fluid and a pump for movement of the heated or cooled fluid. Other heat exchange mechanisms capable of rapidly heating or cooling the fluid in the heated fluid reservoir (114) and/or the cooled fluid reservoir (115) are contemplated in the present invention. The rapid increase or decrease may include a temperature change of about 1 to about 10 degrees celsius over a time of no greater than about 60 minutes, 25 minutes, five minutes, about three minutes, or preferably no greater than about one minute.

The thermal energy system (105, 305, 505) may be illustrated by fig. 3A-C, where fig. 3A depicts the relative proportions of the implantable temperature controller (106, 306) of one embodiment of the thermal energy system (105, 305, 505) and is referenced to a standard pencil point. Fig. 3B depicts a view of the implantable component surrounding the target nerve. Fig. 3C shows details of an implantable component of the thermal energy system (105, 305, 505) located on or near a nerve. At least one heating and/or cooling element (108, 308, 515), (107, 307) provides thermal energy transferred along the conductive material (103) to heat or cool the nerve. In portions of the device not adjacent to the nerve, an insulating material (104) surrounds the conductive material (103) to limit the transfer of thermal energy to the nerve and avoid the transfer of thermal energy to non-target nerves. The entire device or a portion thereof may be coated with a biocompatible coating (102) such that the thermal energy system (105, 305, 505) may be implanted on or near the nerve for a duration of treatment desired without triggering a significant immune response. In one embodiment, the at least one heating element (108, 308, 515) and the at least one cooling element (107, 307) are configured to include horseshoe, C, bowl, and semi-circular shapes, as shown, for example, in fig. 3B-C. In one embodiment, the thermal energy system (105, 305, 505) is constructed of a biocompatible material or includes a biocompatible coating on at least one segment of the device. The biocompatible coating can be a gel, aerogel, hydrogel, microparticle, dermal or other filler, injectable slurry, or other material having a lower thermal conductivity than tissue or blood that does not produce a significant immune response. The biocompatible coating may be present on the thermal energy system (105, 305, 505) prior to implantation, or may be coated on at least a portion of the thermal energy system (105, 305, 505) after implantation. The biocompatible coating may be biodegradable and may degrade over a limited period of time. The degradation may not occur in vivo or may only slowly degrade over an extended period of time in vivo, such as months or years.

In one embodiment, the thermal energy system (105, 305, 505) is completely external and may further comprise a temperature controller (106, 306) comprising at least one heating element (108, 308, 515), at least one cooling element (107, 307), a system controller (109, 309, 510) comprising a processor (111, 311, 522) and at least one feedback sensor (110, 310, 516), such as a temperature sensor in one embodiment, as shown in fig. 1B. In one embodiment, the thermal energy system (105, 305, 505) is an external thermal energy system (105, 305, 505) for reversible blockade of nerves in a subject. The external thermal energy system (105, 305, 505) may comprise a temperature controller (106, 306) comprising at least one heating element (108, 308, 515) and/or at least one cooling element (107, 307) connected to a power supply and the temperature controller (106, 306), the system controller (109, 309, 510) and at least one feedback sensor (110, 310, 516), such as in one embodiment a temperature sensor capable of detecting a temperature at or near the at least one location. The external thermal energy system (105, 305, 505) may be configured to make a transition in temperature between a heating phase enabled by the at least one heating element (108, 308, 515) and a cooling phase enabled by the at least one cooling element (107, 307).

In one embodiment, the at least one heating element (108, 308, 515) may be a resistive heating element, an inductive heating element, a Peltier heater, a microwave heating element, a radio frequency heating element, an infrared emitter, or any other suitable heating means capable of providing the heating temperature and duration required in the mild heating step in the thermal modulation of the nerve. In one embodiment, the at least one cooling element (107, 307) may be a coolant tube, a thermoelectric cooler, a refrigeration system, a Peltier cooler, ice, or any other suitable cooling means capable of providing the cooling temperature and duration required in a moderate cooling step in the thermal modulation of the nerve. In one embodiment, the feedback sensor (110, 310, 516) is a thermocouple, thermistor, or any other suitable device or material capable of monitoring the temperature change of the nerve before, during, and after thermal modulation to block or partially block the nerve. The feedback sensor (110, 310, 516), such as a temperature sensor, may be placed in or near the at least one heating element (108, 308, 515) or the at least one cooling element (107, 307), or elsewhere in or on the body or within the device.

In one embodiment, the at least one heating element (108, 308, 515) of the thermal energy system (105, 305, 505) is a resistive heating element comprising a flexible portion comprising at least one resistive heating element powered by an induction coil receiving a radiated electromagnetic field, the flexible portion being connected to an internal control mechanism. The internal control mechanism may include a temperature controller (106, 306) that may optionally be in wireless communication with the system controller (109, 309, 510).

The temperature controller (106, 306) may be physically or optionally wirelessly connected to a system controller (109, 309, 510) comprising a processor (111, 311, 522) for controlling heating of the at least one heating element (108, 308, 515), cooling of the at least one cooling element (107, 307) and monitoring the temperature at the nerve. The processor (111, 311, 522) may execute programmed instructions that may be stored on a memory of the temperature controller (106, 306). The external thermal energy system (105, 305, 505) may comprise wireless power transfer to the at least one heating element (108, 308, 515), wherein the wireless power is inductive or microwave energy transfer.

The thermal energy system (105, 305, 505) and the system controller (109, 309, 510) are powered by an electrical power source. The power source may be selected from the group consisting of an internal primary battery, an internal (rechargeable) secondary battery, wireless power transfer including inductive power transfer, microwave power transfer, invisible laser power transfer, alternating current and kinetic energy harvesting systems.

In one embodiment, a completely external thermal energy system (105, 305, 505) may be used to provide a method of reversibly blocking nerves in a subject with all or a combination of components of the external thermal energy system (105, 305, 505) by all external means. In one embodiment, the thermal energy system (105, 305, 505) may reversibly block one or more nerves for about minutes, hours, or days or years during a medical procedure to treat a chronic condition or symptom.

In one embodiment, the thermal energy system (105, 305, 505) is fully implantable, and may further comprise a temperature controller (106, 306) comprising at least one heating element (108, 308, 515), at least one cooling element (107, 307), a system controller (109, 309, 510) comprising a processor (111, 311, 522), and at least one feedback sensor (110, 310, 516), such as in one embodiment a temperature sensor, as shown in fig. 1B. In one embodiment, the thermal energy system (105, 305, 505) is an implantable thermal energy system (105, 305, 505) for reversible blockade of nerves in a subject. A fully implantable thermal energy system (105, 305, 505) may comprise a temperature controller (106, 306) comprising at least one heating element (108, 308, 515) and/or at least one cooling element (107, 307) implanted near or on a nerve, and at least one feedback sensor (110, 310, 516), such as in one embodiment a temperature sensor capable of detecting a temperature near at least one location, and a system controller (109, 309, 510) comprising a processor (111, 311, 522) connected to a power source.

In one embodiment, the at least one heating element (108, 308, 515) of the thermal energy system (105, 305, 505) is a resistive heating element comprising a flexible portion comprising at least one resistive heating element powered by an induction coil receiving a radiated electromagnetic field, the flexible portion being connected to an internal control mechanism. The internal control mechanism may include a temperature controller (106, 306) that may optionally be in wireless communication with the system controller (109, 309, 510). In different embodiments, the system controller (109, 309, 510) may be located internally or may be located externally.

The temperature controller (106, 306) may be physically or optionally wirelessly connected to a system controller (109, 309, 510) comprising a processor (111, 311, 522) for controlling heating of the at least one heating element (108, 308, 515), cooling of the at least one cooling element (107, 307) and monitoring the temperature at the nerve. The processor (111, 311, 522) may execute programmed instructions that may be stored on a memory of the temperature controller (106, 306). The thermal energy system (105, 305, 505) and the system controller (109, 309, 510) may be powered by an electrical power source. Wireless power transfer may occur between the power source and the at least one heating element (108, 308, 515), wherein the wireless power transfer includes inductive or microwave energy transfer.

In one embodiment, a fully implantable thermal energy system (105, 305, 505) can be used to provide a method of reversibly blocking nerves in a subject using all or a combination of components of the internal thermal energy system (105, 305, 505) through all internal means. In one embodiment, the thermal energy system (105, 305, 505) may reversibly block one or more nerves for about minutes, hours, or days or years during a medical procedure to treat a chronic condition or symptom.

In various fully implantable or fully external embodiments, at least one feedback sensor (110, 310, 516), such as a temperature sensor capable of detecting temperature in one embodiment, is located at least one location selected from: on or near the skin of the patient, on or near at least one heating element (108, 308, 515), in or near one or more cooling fluid channels, or in or near a thermoelectric cooler. In one embodiment, the thermal energy system (105, 305, 505) may include one or more feedback sensors (110, 310, 516) for monitoring various biomarkers or bio-signals to modify the thermal energy directed to the nerve. The system controller (109, 309, 510) may receive and process the biological signal of the subject from the at least one feedback sensor (110, 310, 516). In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, but the feedback sensor (110, 310, 516) may also monitor a biological signal selected from temperature and chemical levels on or near a nerve. In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, but the feedback sensor (110, 310, 516) may also monitor any other such useful and suitable parameter selected from body temperature, blood pressure, heart rate, time, sweat, blood oxygen saturation, electrocardiogram signals, and/or the patient's health, symptoms, or comfort. In one embodiment, there are a plurality of feedback sensors (110, 310, 516) whose output signals are received by the system controller (109, 309, 510) and/or a processor (111, 311, 522) of the system controller (109, 309, 510), which is configured with software to control the cooling elements (107, 307) and the heating elements (108, 308, 515). The thermal energy system (105, 305, 505) is configured to communicate the parameter detected by the feedback sensor (110, 310, 516) with a system controller (109, 309, 510). In one embodiment, the thermal energy system (105, 305, 505) may be configured by a clinician or user after implantation or external placement on a patient by means of selecting one or more parameters in software or firmware on a processor (111, 311, 522) of the system controller (109, 309, 510) or on the temperature controller (106, 306). In another embodiment, the parameters may be preset. In one embodiment, a user may control communication with a system controller (109, 309, 510), wherein the user may select an input factor from the group consisting of: pain level, range of motor functions, sensory sensitivities including pain touch, sharpness, temperature, and pressure level. The user may also control the system by turning "on" or "off, or by changing the operation at any level.

In various fully implantable or fully external embodiments, such as those depicted in fig. 1B, fluid transport may be utilized to transfer thermal energy of the thermal energy system (105, 305, 505) so that the heating and cooling temperatures indicated by the system controller (109, 309, 510) may be accurately achieved. In one embodiment, heat pipes are utilized to transfer thermal energy of a thermal energy system (105, 305, 505) such that the heating and cooling temperatures indicated by the system controller (109, 309, 510) can be accurately achieved. The heat pipe may be flexible and may be constructed of a biocompatible material.

In a fully implantable or fully external embodiment, at least one of the at least one heating element (108, 308, 515) or the at least one cooling element (107, 307) may comprise a channel (113) for circulating a heated or cooled fluid. In one embodiment, a heated fluid reservoir (114) may be in communication with the channel (113) for circulating the heated fluid. In one embodiment, a cooling fluid reservoir (115) may be in communication with the channel (113) for circulating a cooled fluid. The heated fluid reservoir (114), the cooled fluid reservoir (115), or the recirculating fluid reservoir (512) may be capable of rapidly increasing or decreasing the temperature of the fluid within the reservoir so that the fluid can be circulated to provide heating and cooling of the nerve as directed by the system controller (109, 309, 510). Although fig. 1B shows a channel (113) for conveying heated fluid to a heated fluid reservoir (114) connected to at least one heating element (108, 308, 515), this is an exemplary embodiment and other channel configurations are possible, as described herein. For example, the channel (113) of fig. 1B may be connected to at least one cooling element (107, 307) to communicate the cooled fluid with the cooled fluid reservoir (115).

In several embodiments, the thermal energy system (105, 305, 505) is completely non-invasive and external or completely implantable. The at least one heating element (108, 308, 515) and the at least one cooling element (107, 307) may each comprise a channel (113) in communication with a heated fluid reservoir (114) and a cooled fluid reservoir (115), respectively. The heated fluid reservoir (114) and the cooled fluid reservoir (115) may allow for a rapid increase or decrease in fluid temperature, as indicated by the system controller (109, 309, 510). The rapid increase or decrease may include a temperature change of about 1 to about 10 degrees celsius over a time of no greater than about five minutes, about three minutes, or preferably no greater than about one minute. In one embodiment, a rapid increase or decrease in temperature of the fluid in the heated fluid reservoir (114) and/or the cooled fluid reservoir (115) may be performed using a thermal treatment device similar to that described in U.S. patent 9,283,109, which is incorporated herein by reference in its entirety. The apparatus may further comprise a heat exchanger for heating and/or cooling the fluid and a pump for movement of the heated or cooled fluid. Other heat exchange mechanisms capable of rapidly heating or cooling the fluid in the heated fluid reservoir (114) and/or the cooled fluid reservoir (115) are contemplated in the present invention.

In one embodiment, a thermal temperature of the fluid ranging from about 112 ° F to about 118 ° F is generated and transported from the heated fluid reservoir (115) to the at least one heating element (108, 308, 515) such that the externally applied heated fluid can provide mild heating to the nerve as directed by the system controller (109, 309, 510). In one embodiment, a thermal temperature of the fluid ranging from about 112 ° F to about 114 ° F is generated and transported from the heated fluid reservoir (115) to the at least one heating element (108, 308, 515) such that the externally applied heated fluid can provide an initial mild heating of the nerve as directed by the system controller (109, 309, 510). A thermal temperature of the fluid ranging from about 115 ° F to about 117 ° F can then be generated and transported from the heated fluid reservoir (115) to the at least one heating element (108, 308, 515) such that the externally applied heated fluid can provide increased mild heating to the nerve as directed by the system controller (109, 309, 510). The thermal energy system (105, 305, 505) may be placed directly against the patient's skin or may include a layer of thermally conductive gel to facilitate the transfer of thermal energy from the thermal energy system (105, 305, 505) to the patient.

A thermally conductive gel, self-curing polymer, foam, plastic, or other biocompatible polymer or composite material may be injected or inserted into the body such that the gel or material may improve the performance of the thermal energy system (105, 305, 505) by increasing the thermal conductivity and thermal energy transfer rate in the region between the device and the target nerve. The thermally conductive gel or material may also spread thermal energy over a greater distance than it could otherwise spread, which may allow many nerves to receive the thermal energy. Such propagation of thermal energy may be useful at locations such as the intra-articular area of the knee or along the surgical site incision thermally modulating nerves. Thermally conductive gels, foams, or other carrier materials are typically made by mixing a base polymer with a thermally conductive filler. The base polymer may include hydrogels and silicones, including gels that can be injected at room temperature and set in place to their final shape at body temperature. Fillers may include graphite, carbon fibers, and ceramics, commonly used to create thermally conductive polymers with thermal conductivities in the range of 1-40W/mK, such as CoolPoly-D, CoolPoly elastomers and CoolPoly-E materials commercially available through Celanese. Other thermally conductive gels or materials are contemplated for use in the present invention. The use of a thermally conductive gel or material can improve the performance of the thermal energy system (105, 305, 505) by increasing the thermal conductivity and thermal energy transfer rate between the device and the target nerve. The thermally conductive gel or material may also spread thermal energy over a greater distance than it would otherwise be spread, which may allow many nerves to receive thermal energy. Such distribution of thermal energy may be useful in locations such as the intra-articular area of the knee. Other thermally conductive gels or materials are contemplated for use in the present invention.

In one embodiment, cold temperatures of fluid in the range of about 6 ℃ to about 10 ℃ are generated and transported from the cooled fluid reservoir (115) to the at least one cooling element (107, 307) so that the externally applied cooled fluid can provide moderate cooling to the nerve as directed by the system controller (109, 309, 510). In one embodiment, the cold temperature of the fluid may be about or greater than about 0 ℃, and the temperature may be raised to a range of about 6 ℃ to about 10 ℃ as desired for patient comfort.

In one embodiment, a thermally conductive material may be infused near the nerve prior to blocking or partially blocking the nerve using the heating and cooling steps. In one embodiment, prior to blocking or partially blocking axons of a nerve using the heating and cooling steps, an insulating material may be infused in the vicinity of the nerve.

In one embodiment of the invention, as shown by way of example in fig. 4, the thermal energy system (105, 305, 505) comprises a temperature controller (106, 306) comprising at least one heating element (108, 308, 515) implanted near or on a nerve, a cooling element (107, 307) placed externally on the skin of the subject, at least one temperature sensor capable of detecting the temperature near the at least one location, and a system controller (109, 309, 510) connected to the power supply.

In one embodiment, the at least one heating element (108, 308, 515) may be a resistive heating element, an inductive heating element, a Peltier heater, a microwave heating element, a radio frequency heating element, and an infrared emitter, or any other suitable heating means capable of providing the heating temperature and duration required in the mild heating step in the thermal modulation of the nerve. In one embodiment, the at least one cooling element (107, 307) may be a coolant tube, a thermoelectric cooler, a refrigeration system, a Peltier cooler, ice, or any other suitable cooling means capable of providing the cooling temperature and duration required in a moderate cooling step in the thermal modulation of the nerve. In one embodiment, the cooling element (107, 307) cools fluid conducted to the interface of the skin in one or more cooling fluid channels. In one embodiment, the feedback sensor (110, 310, 516) is a thermocouple, thermistor, or any other suitable device or material capable of monitoring the temperature change of the nerve before, during, and after thermal modulation to block or partially block the nerve. The temperature sensor may be placed in or near the at least one heating element (108, 308, 515) or the at least one cooling element (107, 307), or elsewhere in or on the body or within the device.

In one embodiment, the at least one heating element (108, 308, 515) may comprise a resistive heating element powered by inductive means. The at least one heating element (108, 308, 515) of the thermal energy system (105, 305, 505) may be a resistive heating element comprising a flexible portion comprising at least one resistive heating element powered by an induction coil receiving a radiated electromagnetic field. In one embodiment, the flexible portion of the thermal energy system (105, 305, 505) may be connected to an internal control mechanism comprising a temperature controller (106, 306), wherein said temperature controller (106, 306) may optionally be in wireless communication with the system controller (109, 309, 510). In different embodiments, the system controller (109, 309, 510) may be located internally or may be located externally.

In one embodiment, at least one heating element (108, 308, 515) is heated by power received from the percutaneous line. In one embodiment, at least one heating element (108, 308, 515) is heated by heated fluid received through a percutaneous tube from a heated fluid reservoir in fluid communication with a heated fluid pump controlled by a system controller (109, 309, 510).

In one embodiment, at least one feedback sensor (110, 310, 516), such as a temperature sensor capable of detecting temperature in one embodiment, is located in at least one location selected from: on or near the skin of the patient, on or near at least one heating element (108, 308, 515), in or near one or more cooling fluid channels, or in or near a thermoelectric cooler. In one embodiment, the thermal energy system (105, 305, 505) may include one or more feedback sensors (110, 310, 516) for monitoring various biomarkers or bio-signals to modify the thermal energy directed to the nerve. The system controller (109, 309, 510) may receive and process the biological signal of the subject from the at least one feedback sensor (110, 310, 516). In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, but the feedback sensor (110, 310, 516) may also monitor a biological signal selected from temperature and chemical levels on or near a nerve. In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, but the feedback sensor (110, 310, 516) may also monitor any other such useful and suitable parameter selected from body temperature, blood pressure, heart rate, time, sweat, blood oxygen saturation, electrocardiogram signals, and/or the patient's health, symptoms, or comfort. In one embodiment, there are a plurality of feedback sensors (110, 310, 516) whose output signals are received by the system controller (109, 309, 510) and/or a processor (111, 311, 522) of the system controller (109, 309, 510), which is configured with software to control the cooling elements (107, 307) and the heating elements (108, 308, 515). The thermal energy system (105, 305, 505) is configured to communicate the parameter detected by the feedback sensor (110, 310, 516) with a system controller (109, 309, 510). In one embodiment, a system controller (109, 309, 510) receives a biological signal of a subject from at least one feedback sensor (110, 310, 516). In one embodiment, the thermal energy system (105, 305, 505) may be configured by a clinician or user after implantation or external placement on a patient by means of selecting one or more parameters in software or firmware on a processor (111, 311, 522) of the system controller (109, 309, 510) or on the temperature controller (106, 306). In another embodiment, the parameters may be preset. In one embodiment, a user may control communication with a system controller (109, 309, 510), wherein the user may select an input factor from the group consisting of: pain level, range of motor functions, sensory sensitivities including pain touch, sharpness, temperature, and pressure level. The user may also control the system by turning "on" or "off, or by changing the operation at any level.

In one embodiment, the thermal energy system (105, 305, 505) may provide information to assist in acceptable placement of the thermal energy system (105, 305, 505). In one embodiment, the thermal energy system (105, 305, 505) may be configured to facilitate acceptable placement of the thermal energy system (105, 305, 505) after partially or completely blocking the nerve using a heating step followed by a cooling step. In this embodiment, the thermal energy system (105, 305, 505) may determine acceptable placement of the thermal energy system (105, 305, 505) based on an effect on the patient selected from the group consisting of sensation, body temperature, blood pressure, heart rate, time, sweat, oxygen saturation, electrocardiogram signals, temperature and chemical levels on or near nerves, or any other such useful and suitable parameter of the patient's health, symptoms or comfort. In one embodiment, a feedback loop may be used to control the power delivered to the thermal energy system (105, 305, 505) based on the temperature detected by a feedback sensor (110, 310, 516) including, but not limited to, a temperature sensor.

A system controller (109, 309, 510) comprising a processor (111, 311, 522) may be physically or wirelessly connected to the control electronics (513) for controlling the heating (515) of the at least one heating element (108, 308), the cooling of the at least one cooling element (107, 307) and monitoring the temperature at the nerve. The system controller (109, 309, 510) may be implanted or located external to other components of the thermal energy system (105, 305, 505). Wireless power transfer may be used to provide power to the at least one heating element (108, 308, 515), where wireless power transfer may include inductive or microwave energy transfer.

In one embodiment, a resistive heating implant (506) of a thermal energy system (105, 305, 505) may be implanted on or near a nerve to reversibly block the nerve. In a preferred embodiment, as shown in the example in fig. 4, a resistive heating implant (506) of a thermal energy system (105, 305, 505) may be implanted on or near the nerve to reversibly block the nerve from heating. The thermal energy system (105, 305, 505) may also include an external chiller (chiller) pump (507) and a wearable device (508) including a system controller (109, 309, 510), an external cooling delivery device (509), and an inductive power supply (511). The inductively heated implant (506) may optionally include an echogenic guide (514), control electronics (513), at least one heating element (108, 308, 515), and at least one feedback sensor (110, 310, 516). The components of the thermal energy system (105, 305, 505) are described in detail below.

The resistively heated implant (506) may be implanted for a period of about several minutes to block one or more nerves during a medical procedure for about several hours or days, or for years to treat a chronic disease or condition. In one embodiment, the resistively heated implant (506) may be a thin, linear, and generally flexible implant, as shown by way of example in fig. 5A. The resistively heated implant (506) may include a rigid portion (525) and a flexible portion (526). The rigid portion (525) may house control electronics (513) including at least one positive thermal coefficient resistor element (519), a main inductive element (520), at least one power control MOSFET (518), a microcontroller (517) and supporting passive electronics (521) (according to operational requirements). The flexible portion (526) may house at least one heating element (108, 308, 515) and at least one feedback sensor (110, 310, 516) (such as for sensing temperature). The at least one heating element (108, 308, 515) and the at least one feedback sensor (110, 310, 516) may be components of at least one Printed Circuit Board (PCB) (524). In one embodiment, the flexible portion (526) may include a flexible circuit including at least one PCB (524).

In one embodiment, at least one section of the thermal energy system (105, 305, 505) or at least one component of the thermal energy system (105, 305, 505) is comprised of a biocompatible material or comprises a biocompatible coating on at least one segment of the device. The biocompatible coating can be a gel, aerogel, hydrogel, particulate, dermal or other filler, injectable slurry, or other material having a lower thermal conductivity than tissue or blood that does not produce a significant immune response. A biocompatible coating may be present on the inductively heated implant (506) prior to implantation, or may be coated on at least a portion of the inductively heated implant (506) after implantation. The biocompatible coating may be biodegradable and may degrade over a limited period of time. The degradation may not occur in vivo or may only slowly degrade over an extended period of time in vivo, such as months or years.

In one embodiment, the thermal energy system (105, 305, 505) may include a feedback sensor (110, 310, 516) for monitoring a biological signal selected from temperature and chemical levels on or near a nerve. In one embodiment, the thermal energy system (105, 305, 505) may include a feedback sensor (110, 310, 516) for monitoring any other such useful and suitable parameter selected from body temperature, blood pressure, heart rate, time, sweat, blood oxygen saturation, electrocardiogram signals, and/or the health, symptoms, or comfort of the patient. The thermal energy system (105, 305, 505) may be capable of communicating the parameter detected by the feedback sensor (110, 310, 516) with a system controller (109, 309, 510). In one embodiment, a user may control communication with a system controller (109, 309, 510), wherein the user may select an input factor from the group consisting of: pain level, range of motor functions, sensory sensitivities including pain touch, sharpness, temperature, and pressure level. The user may also control the system by turning "on" or "off, or by changing the operation at any level.

In one embodiment, the thermal energy system (105, 305, 505) may provide information to assist in acceptable placement of the thermal energy system (105, 305, 505). In a preferred embodiment, the thermal energy system (105, 305, 505) may provide information to assist in acceptable placement of the thermal energy system (105, 305, 505) after the nerve is partially or completely blocked using a heating step followed by a cooling step. In this embodiment, the thermal energy system (105, 305, 505) may determine acceptable placement of the thermal energy system (105, 305, 505) based on an effect on the patient selected from the group consisting of sensation, body temperature, blood pressure, heart rate, time, sweat, oxygen saturation, electrocardiogram signals, temperature and chemical levels on or near nerves, or any other such useful and suitable parameter of the patient's health, symptoms or comfort. In one embodiment, the placement of the thermal energy system (105, 305, 505) may also be guided by user input factors selected from the group consisting of pain level, range of motor function, sensory sensitivity including pain touch, sharpness, temperature and pressure level. In one embodiment, the power delivered to the thermal energy system (105, 305, 505) may be controlled using a feedback loop based on the temperature detected by the feedback sensor (110, 310, 516).

In one embodiment, a thermal energy system (105, 305, 505) includes a system controller (109, 309, 510) including a processor (111, 311, 522) in communication with a resistively heated implant (506), an external cooling delivery device (509), an inductive power supply (511), and an external chiller pump (507). The communication of the system controller (109, 309, 510) is described in detail below.

In one embodiment, a resistively heated implant (506) of a thermal energy system (105, 305, 505) provides heat to the nerve and is powered by a radiated electromagnetic field from an inductive power supply (511), as directed by a system controller (109, 309, 510). In a preferred embodiment, a microcontroller (517) within the resistively heated implant (506) is in communication with the system controller (109, 309, 510) and, upon receiving a safety enable signal from the system controller (109, 309, 510), determines a temperature set point, a duration of heating, controls power to the at least one heating element (108, 308, 515), and directs other functions of the resistively heated implant (506) as needed to reversibly block nerves. The microcontroller (517) may be capable of wireless communication with the system controller (109, 309, 510) or may be physically connected to the system controller (109, 309, 510). The wireless communication may occur via a bluetooth connection or any other suitable wireless communication means. The microcontroller (517) may not be able to recognize extraneous wireless signals so that accidental heating events of the resistively heated implant (506) may be avoided.

In one embodiment, the inductive power supply (511) powers the resistively heated implant (506), as directed by the system controller (109, 309, 510). The inductive power supply (511) may be positioned relative to the resistively heated implant (506) such that it can inductively power the inductively heated implant (506). A microcontroller (517) of the inductively heated implant (506) may utilize at least one power control MOSFET (518) or other solid state switch to limit the power transferred from the inductive power supply (511) to the at least one heating element (108, 308, 515). The at least one power control MOSFET (518) may be pulse width modified. The at least one power control MOSFET (518) may be used to gradually ramp up power so that the at least one heating element (108, 308, 515) reaches its temperature set point. In a preferred embodiment, the temperature set point of the at least one heating element (108, 308, 515) is about 45 ℃. A microcontroller (517) may be used to maintain the low power level and direct continuous monitoring of temperature during nerve cooling. The microcontroller (517) may be in continuous communication with the system controller (109, 309, 510) to create a continuous feedback loop. The positive thermal coefficient resistor element (519) may be used as a fault protection system to limit power to the inductively heated implant (506) in an analog manner in the event of a malfunction. A built-in fuse within at least one heating element (108, 308, 515) may protect the at least one heating element (108, 308, 515) from an overcurrent event and shut down the at least one heating element (108, 308, 515) in such an overcurrent event.

In one embodiment, the at least one heating element (108, 308, 515) may be a resistive heating element, an inductive heating element, a Peltier heater, a microwave heating element, a radio frequency heating element, and an infrared emitter, or any other suitable heating means capable of providing the heating temperature and duration required in the mild heating step in the thermal modulation of the nerve. In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, such as a thermocouple, thermistor, or any other suitable device or material capable of monitoring the change in temperature of the nerve before, during, and after thermal modulation to block or partially block the nerve. The feedback sensor (110, 310, 516) may be placed in or near the at least one heating element (108, 308, 515), or elsewhere in or on the body or within the device. In one embodiment, an optional at least one echogenic guide (514) or other such suitable guiding material or device is located within the resistively heated implant (506) to aid in the placement of the resistively heated implant (506).

In one embodiment, cooling of the nerve by a thermal energy system (105, 305, 505) may be applied externally. In one embodiment, cooling of the nerve is delivered by an external cooling delivery device (509) connected to an external chiller pump (507). The external cooling delivery device (509), inductive power supply (511) and system controller (109, 309, 510) may be positioned at a target location against the skin covering the implanted resistively heated implant (506) and its target nerve, as described in fig. 4 and shown in the example in fig. 5B. In a preferred embodiment, the external cooling delivery device (509), inductive power supply (511) and system controller (109, 309, 510) are contained within the wearable device (508) such that the wearable device (508) can be positioned at a target location, wherein the target location is against the skin covering the implanted resistively heated implant (506) and its target nerve. The wearable device (508) may be a patch, headband, belt, band or any other such component containing the external cooling delivery device (509), inductive power supply (511) and system controller (109, 309, 510) at the target location and providing thermal contact (508) between the skin and the wearable device. In one embodiment, the wearable device (508) may be made of a soft, conformal elastic materialMade of a material (e.g., Shore Scale 25A) having a tape or other such suitable means to conform to the target site of the patient. In one embodiment, a thin, conformal, thermally conductive elastomer (such as

Thermally conductive plastic (Celanese, Ltd.)) may cover the side of the wearable device (508) that is in contact with the patient's skin so that the wearable device (508) may be in thermal contact. In one embodiment, a thermally conductive gel may be used to improve thermal contact with the wearable device (508). In a preferred embodiment, the wearable device (508) may be a headband positioned to treat a condition involving pain associated with occipital nerves.

An external cooling delivery device (509) of the thermal energy system (105, 305, 505) may cool the nerve using a cryogenic fluid provided by an external chiller pump (507). In one embodiment, the external cooling delivery device (509) and the external chiller pump (507) are contained within a wearable device (508). In a preferred embodiment, the external cooling delivery device (509) is contained within the wearable device (508) and connected to a separately located external chiller pump (507). The external cooling delivery device (509) and the external chiller pump (507) may be connected by a cooling fluid path, which may be insulated, such that the chilled fluid may be directed from the external chiller pump (507) to the external cooling delivery device (509) at the target location, and the recirculated fluid may be returned from the external cooling delivery device (509) to the external chiller pump (507) for chilling. In one embodiment, the external chiller pump (507) may include a Peltier cooling system so that the recirculated fluid may be chilled into a chilled fluid for reuse. The recirculated fluid may be collected in a recirculated fluid reservoir (512) of an external chiller pump (507), wherein the temperature of the fluid within the recirculated fluid reservoir (512) may be rapidly increased or decreased as indicated by a system controller (109, 309, 510). In one embodiment, the system controller (109, 309, 510) may direct an external chiller pump (507) to control the chilled fluid temperature and flow rate within the cooling fluid path. The external chiller pump may include at least one feedback sensor (110, 310, 516) to monitor the temperature of the chilled fluid, the recirculated fluid, and the temperature within the recirculated fluid reservoir (512). The at least one feedback sensor (110, 310, 516) may be in communication with the system controller (109, 309, 510) to provide a temperature measurement continuously or as directed by the system controller (109, 309, 510).

The recirculating fluid and the refrigeration fluid may have the same composition and be located within a cooling fluid path of the thermal energy system (105, 305, 505). The only significant difference between the recycled fluid and the cryogenic fluid may be their respective temperatures, and the recycled fluid and the cryogenic fluid may be switched between each other by altering their temperatures. Both the recirculated fluid and the refrigeration fluid may be composed of saline or any other suitable fluid such that the fluid may be refrigerated to the temperature required to cool the nerve without freezing the fluid. In a preferred embodiment, the cryogenic fluid may be chilled to a temperature of about 0 ℃ or slightly below about 0 ℃, such that the nerves may be cooled to a temperature indicated by the system controller (109, 309, 510).

Fig. 6A-B illustrate the effect of distance on heating and cooling of tissue. In fig. 6A, a cooling step required to cool the nerve to approximately 15 ℃ is demonstrated using simulations. In the simulation, it was determined that the cryogenic fluid can provide a temperature of 0 ℃ to the patient's skin at the target location for about 10 minutes to bring the nerves within 8mm of the skin surface to a temperature of 15 ℃, and that the cryogenic fluid can provide a temperature of 0 ℃ to the patient's skin at the target location for about 20 to about 30 minutes to bring the nerves within 20mm of the skin surface to a temperature of 15 ℃. Beyond 20mm deep from the skin surface, it may be impractical to externally cool the nerve because the required cryogenic fluid temperature may be uncomfortable or intolerable to the patient and may require additional energy generation. It has been determined that once a nerve cooling temperature of 15℃ is reached, it is possible to maintain the cooling temperature at the nerve at 15℃ at the patient's skin surface with a cryogenic fluid having a temperature in the range of about 8℃ to about 10℃. In fig. 6B, the implanted resistively heated implant (506) is heated to 45 ℃ at a depth of 20mm within the tissue and the temperature of the tissue is monitored at a different distance from the resistively heated implant (506). The heat from the resistively heated implant (506) maintains a target temperature approximately equal to 45 ℃, while the temperature of the tissue decreases by a few degrees with distance.

Insertion of the resistively heated implant (506) may be performed by any suitable insertion or surgical means known in the art. In one embodiment, insertion of the resistively heated implant (506) may be performed using an insertion device (535), as shown in fig. 7. The insertion device (535) may include an insertion sheath (538), a sheath control arm (537), and a plunger (536), and may be constructed of any material that can be sterilized for insertion into a patient. An insertion sheath (538) may surround or otherwise contain or incorporate the resistively heated implant (506) and guide the resistively heated implant (506) to a target location for insertion. The sheath control arm (537) may be pulled by the clinician holding the plunger (536) such that the insertion sheath (538) may be retracted, the resistively heated implant (506) may be exposed, and the insertion device (535) may be removed from the target site. An implanted resistively heated implant (506) may be retained in its target position of insertion.

In one embodiment, a thermal energy system (105, 305, 505) includes a thermal energy probe (405). As shown in the example in fig. 8, the thermal energy probe (405) may be configured in a shape including a horseshoe shape, a C shape, a U shape, a bowl shape, and a semi-circle shape. A thermal energy probe (405) may be implanted at or near the nerve to provide heating and/or cooling so that the nerve may undergo reversible blockages. In one embodiment, the thermal energy probe (405) is U-shaped and extends around the nerve. The material of the thermal energy probe (405) may be comprised of any material that is thermally conductive and biocompatible when implanted at or near a nerve. In one embodiment, the thermal energy probe (405) is comprised of silver. The thermal energy probe (405) may be produced by 3D printing, injection molding, commercial casting processes, or any other suitable production technique.

The thermal energy probe (405) may be sized such that it scales with the diameter of the nerve, such that the thermal energy probe (405) may extend around or along the nerve for a particular distance, as desired for reversible blockage of the nerve. In one embodiment, as shown in fig. 9, a U-shaped thermal energy probe (405) surrounds the nerve from three of the four sides of the plan on-axis view such that a uniform temperature distribution can be maintained over at least a section of the nerve. Thus, the cross-sectional parameters of the thermal energy probe (405) may be determined by the diameter of the nerve it may target for reversible blockages. The thermal energy probe (405) may have millimeter dimensions, including for example a 4mm by 3mm by 5mm thermal energy probe (405) for a 2mm diameter and 2mm axial cross section of a nerve.

In one embodiment, the size of the thermal energy probe (405) may be calculated from the dimensions of the target nerve according to equations (1) - (4) with reference to the dimensions in fig. 10A-B:

X1＝D+1.5mm (1)

X2＝X1+2mm (2)

Y＝D+2mm (3)

Z＝Zn+1.5mm (4)

in equation (1), X1 is the dimension of the U-shaped thermal energy probe (405), as shown in fig. 10A. The diameter of the nerve is D. In equation (2), X1 is the dimension of the U-shaped thermal energy probe (405), as shown in fig. 10A. In equation (3), Y is the dimension of the U-shaped thermal energy probe (405), as shown in fig. 10A. In equation (4), Z is the dimension of the U-shaped thermal energy probe (405), as shown in fig. 10B. The axial length of the target nerve is Zn.

In one embodiment, the thermal energy probe may further comprise at least one fluid channel (406) such that heated fluid or cooled fluid may enter the thermal energy probe (405) and transfer thermal energy to the thermal energy probe (405) to heat or cool the nerve. The at least one fluid channel (406) may have a diameter of about 0.3mm or any diameter suitable for a tight fit of the tube (407). The length of the at least one fluid channel (406) may be about 1.5mm, or any other suitable length, such that the tube (407) may be securely held in place and the size of the thermal energy probe (405) minimized for implantation. At least one fluid channel (406) may provide an inlet and an outlet for heated or cooled fluid and may be located on the back of the thermal energy probe (405) or at any suitable location to provide heated or cooled fluid to the thermal energy probe (405). The heated or cooled fluid may be water, saline, or any other suitable fluid such that the fluid may be heated or cooled to a temperature required to heat or cool the nerve without the fluid evaporating or freezing. The cooled or heated fluid may exit the thermal energy probe (405) through at least one fluid channel (406) that may serve as an outlet. In one embodiment, a conduit (407) may be used to carry the cooled or heated fluid through the at least one fluid channel (406), wherein the conduit (407) is flexible, insulating, and conforms to the dimensions of the at least one fluid channel (406) to closely fit.

In one embodiment, the thermal energy probe (405) further includes a coating of conductive gel (408) on the surface closest to the nerve, as shown in fig. 9-11. The conductive gel (408) may be used to buffer the nerve within the thermal energy probe (405) and may facilitate the transfer of thermal energy from the thermal energy probe (405) to the nerve. The conductive gel (408) may also function to maintain a low level of temperature change across at least a segment of the nerve. The higher thermal conductivity of the conductive gel (408) can result in more efficient thermal energy transfer from the thermal energy probe (405). The conductive gel (408) may be biocompatible for implantation at or near a nerve. Other thermally conductive gels or materials are contemplated for use in the present invention.

In one embodiment, the thermal energy probe (405) may include an insulating backing (409) on at least one non-nerve contacting surface of the thermal energy probe (405). The insulating backing (409) may comprise a solid material that conforms to the characteristics of the thermal energy probe (405) and is insulated with low thermal conductivity. In one embodiment, the insulating backing (409) is made of polyurethane and the thermal conductivity of the insulating backing (409) is about 0.027W/mK. An insulating backing (409) may be placed on the back surface of the thermal energy probe (405) and may conform to features such as the at least one fluid channel (406). The insulating backing (409) may prevent loss of thermal energy from the thermal energy probe (405). A thermal energy probe (405) with an insulating backing (409) is shown in fig. 11.

In one embodiment, a thermal energy probe (405) is implanted at or near the nerve for reversible occlusion. Placement of the thermal energy probe (405) may be guided by ultrasound and inserted through the incision using an applicator or other such suitable device for placement of the thermal energy probe (405). The thermal energy probe (405) may be positioned such that the nerves are buffered by a conductive gel (408) coated on the surface of the thermal energy probe (405). In the case of a U-shaped thermal energy probe (405), a conductive gel (408) may be applied to the inside of the U-shaped feature. In one embodiment, an insulating material (410) may be injected or placed around the thermal energy probe (405) during insertion. The insulating material (410) may limit thermal energy transfer to a desired location and may help maintain the thermal energy probe (405) in its position at or near the nerve. The insulating material (410) may be injected in a generally spherical shape around the nerve and thermal energy probe (405) and may involve one or more injections to apply it to a desired location. In one embodiment, the insulating material (410) may be injected into a sphere of 10mm in diameter. The insulating material (410) may be insulating and biocompatible, and may be a liquid, gel, or foam. In a preferred embodiment, the insulating material (410) is a polyurethane foam having a thermal conductivity of about 0.027W/mK. Low thermal conductivity of the insulating material (410) is desired. The viscosity of the insulating material (410) should be low enough to allow injection to the site, but high enough to prevent it from leaving the target area after a period of installation. The desired insulating material (410) may be a self-setting material that is injected in liquid form and then undergoes a chemical reaction to cure and set (set up) to maintain its shape and position, such as BioFoam Surgical Matrix by CryoLife.

A thermally insulating gel, self-setting polymer, foam, plastic, or other biocompatible polymer or composite material may be injected or inserted into the body such that the gel or material may direct or contain heating and/or cooling of the thermal energy system (105, 305, 505) by reducing thermal conductivity and thermal energy transfer rates in areas outside of the desired area of influence around the device and the targeted nerve. The insulating gel or material may also prevent the spread of thermal energy over an area that would otherwise be spread, which may allow more targeted use of thermal modulation or use of thermal modulation near areas where thermal modulation is not desired. Such containment of thermal energy can be useful at locations such as nerves specifically targeted to cause discomfort in the joint, without affecting nerves that control motion or sensation that do not cause pain. Insulation gels, foams, or other carrier materials are typically made by mixing a base polymer with an insulation filler. The base polymer may include hydrogels and silicones, including gels that can be injected at room temperature and set in place to their final shape at body temperature. Fillers may include polyurethane foams, polystyrene, fiberglass, and aerogels, such as those commonly used to create insulating polymers with thermal conductivities in the range of 0.1-01W/mK, such as polystyrene, cabotcp aerogels, and polyurethane foams from General Plastics, inc. Other insulating gels or materials are contemplated for use in the present invention.

The thermal energy probe (405) may include a positioning hook that may be deployed after insertion such that the thermal energy probe (405) is locked in a desired position at or near the nerve.

In one embodiment, the thermal energy probe (405) may be connected to an assembly for controlling fluid flow and temperature. The assembly may be implanted or may be external to the patient. The assembly may include a pump, a heat exchanger, a thermoelectric cooler, a system controller (109, 309, 510), a power source, and piping (407). As shown in fig. 12A-B, and as indicated by the system controller (109, 309, 510), a pump may be used to deliver heating or cooling fluid through tubing (407) into the thermal energy probe (405). The power source may be a battery or any other power source suitable for powering components of the thermal energy system (105, 305, 505).

In one embodiment, a heat exchanger and a thermoelectric cooler are used to heat and cool the fluid, respectively. In one embodiment, the heating fluid is about 42C to about 54C. In one embodiment, the cooling fluid is about 2C to about 15C. In a preferred embodiment, during heating and cooling, the cooling fluid is about 15C and the heating fluid is about 50C, with the temperature of the surrounding tissue being + -2C. A system controller (109, 309, 510) may direct the heat exchanger and/or the thermoelectric cooler such that the temperature may be maintained at the nerve. The fluid may be recirculated from the thermal energy probe (405) back to the heat exchanger and/or thermoelectric cooler for heating or cooling. In one embodiment, the flow rate of the heating or cooling fluid may be in the range of about 0.0004L/min to about 0.0001L/min, depending on the temperature of the heating or cooling fluid. The pump may provide a pressure of about 5mbar to about 400mbar to achieve these flow rates, depending on the diameter of the conduit (407).

As shown in the examples in fig. 13A-C, a device or system for thermal modulation of reversible blockages may be adjusted based on the type and duration of pain and the depth of the nerve from the skin. In one embodiment, pain associated with a nerve may be chronic or acute, where chronic pain may be chronic and may last for days, weeks, months or years, while acute pain may be recent and/or sudden and may occur within a short time of hours, days, weeks or months. In one embodiment, chronic pain can occur over a duration of at least about three months. In one embodiment, acute pain may occur for a duration equal to or less than about two weeks. Chronic pain may include periods of remission or relapse, and may affect one or more areas of the body. Acute pain can be severe and can affect one or more areas of the body. Chronic or acute pain may be persistent or sporadic, where persistent pain may occur continuously at one or more levels of severity, and sporadic pain may occur intermittently at one or more levels of severity with regular or irregular episodes. The device determination in fig. 13A-C is exemplary, and the method of device selection and use may vary from patient to patient. The depth range of the target nerve considered for various embodiments of the present invention may vary from patient to patient and is exemplary in fig. 13A-C.

The selection of implantable or externally mounted heating and/or cooling elements (108, 308, 515), (107, 307) is based at least in part on the depth of the nerve and the individual's own sensory perception and temperature tolerance. When the nerve depth under the skin is less than or equal to about 4 to 8 millimeters, most patients can generate sufficient nerve heating from the outside by the heating element (108, 308, 515) to initiate and maintain nerve block, e.g., the nerve temperature is near 40-45 ℃, in which case the heating element (108, 308, 515) may be preferentially outside of this range unless the patient is particularly sensitive to warm temperatures or prefers to implant the heating element (108, 308, 515). Blocking nerves that are deeper than about 4 to 8 millimeters below the surface of the skin will generally require implanting a heating element (108, 308, 515) so as to be located within about 1 to 8 millimeters from the nerve when implanted. When the depth of the nerve does not exceed about 20 to 25 millimeters, sufficient nerve cooling may be generated externally through the skin by the cooling element (107, 307) to initiate and maintain nerve block, for example, nerve temperatures in the range of about 15-30 ℃ may be generated, so the cooling element (107, 307) may optionally be implanted or external for nerve depths in this range. When the nerve is deeper than about 20-25 mm, the cooling element (107, 307) and the heating element (108, 308, 515) should generally be implanted for maximum efficacy so that the cooling element (107, 307) is within about 20-25 mm of the nerve and the heating element (108, 308, 515) is within about 4-8 mm of the nerve. These ranges can be shortened by inserting a thermally conductive material (such as a gel, elastomer, or other mixture) between the heating and/or cooling elements (108, 308, 515), (107, 307) and the nerve.

In one embodiment, as depicted by way of example in fig. 13A, the thermal modulation includes reversible blockade (205) for treating chronic persistent pain. In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. The thermal modulation of nerves can be tested in a clinical setting to assess the effectiveness of reversible blockade. In the event that thermal modulation is successful, the thermal modulation device or system may be used either externally or as an implantable device. In a preferred embodiment, the thermal modulation may be applied from a totally implantable thermal system (206). In case the thermal modulation is not successful, the thermal modulation may not be suitable for treatment and other options may be explored (207).

In one embodiment, as depicted by way of example in fig. 13A, the thermal modulation includes a reversible block (208) for treating chronic sporadic pain. In one embodiment, the nerve is located at a depth of about 20mm from the patient's skin (209). In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment where the nerve is located at a depth within about 20mm of the patient's skin, thermal modulation may be applied from a fully implantable thermal system (206). In the event that thermal modulation is unsuccessful, heat may not be suitable for treatment and other options may be explored (207). In one embodiment, the nerve is located at a depth (210) of about 6mm to about 20mm from the patient's skin. In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment where the nerve is located at a depth of about 6mm to about 20mm from the patient's skin, thermal modulation may be applied with transcutaneous cooling (220) and an implantable inductive heating device (219). In the case where thermal modulation is unsuccessful or partially successful, heat may not be suitable for treatment and other options may be explored (207). In one embodiment, the nerve is located at a depth of less than about 6mm from the patient's skin (211). In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment, the thermal modulation may be applied with a transcutaneous heating and cooling device (212) when the nerve is located at a depth of less than about 6mm from the patient's skin. In the case where thermal modulation is unsuccessful or partially successful, thermal modulation may not be appropriate for treatment and other options may be explored (207).

In one embodiment, as depicted by way of example in fig. 13B, the thermal modulation includes an eligibility block (213) for treating acute persistent pain. In one embodiment, the nerves are located at a depth of greater than about 20mm from the patient's skin (209), or within a range of about 6mm to about 20mm from the patient's skin (210). In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment, when the nerve is located above about 20mm from the patient's skin or within about 6mm to about 20mm from the patient's skin, the thermal modulation device may be a temporary thermal probe (215) so that the physician can assess if thermal modulation needs to continue as needed. In the event that continued thermal modulation is required (216), the device may continue to be utilized. In the event thermal modulation is no longer required (217), the device may be removed (218). In case the thermal modulation is not successful, the thermal modulation may not be suitable for treatment and other options may be explored (207). In one embodiment, the nerve is located at a depth of less than about 6mm from the patient's skin (211). In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment where the nerve is located at a depth of less than about 6mm from the patient's skin, the thermal modulation may be applied by a transcutaneous heating and cooling device (212). In the case where thermal modulation is unsuccessful or partially successful, thermal modulation may not be appropriate for treatment and other options may be explored (207).

In one embodiment, as depicted by way of example in fig. 13B-C, thermal modulation includes reversible blocking (214) for treating acute sporadic pain. In one embodiment, the nerve is located at a depth of about 20mm from the patient's skin (209). In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment where the nerve is located at a depth of about 20mm or more from the patient's skin, the thermal modulation device may be a temporary thermal probe (215) so that the physician can assess if thermal modulation needs to continue as needed. In the event that continued thermal modulation is required (216), the device may continue to be utilized. In the event thermal modulation is no longer required (217), the device may be removed (218). In the event that thermal modulation is unsuccessful, thermal or electrical modulation may not be suitable for treatment and other options may be explored (207). In one embodiment, the nerve is located at a depth (210) of about 6mm to about 20mm from the patient's skin. In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In one embodiment, thermal modulation is tested in a clinical setting and reversible blockages are evaluated. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment where the nerve is located at a depth of about 6mm to about 20mm from the patient's skin, thermal modulation may be applied with transcutaneous cooling (220) and an implantable inductive heating device (219). In the case where thermal modulation is unsuccessful or partially successful, thermal modulation may not be appropriate for treatment and other options may be explored (207). In one embodiment, the nerve is located at a depth of less than about 6mm from the patient's skin (211). In this case, the target nerve's response may first be tested in a clinical setting to determine its response to thermal modulation. In one embodiment, thermal modulation is tested in a clinical setting and selective blockade is evaluated. In case the thermal modulation is successful, the thermal modulation device or system may be used externally, or it may be used as an implantable device. In a preferred embodiment where the nerve is located at a depth of less than about 6mm from the patient's skin, the thermal modulation may be applied by a transcutaneous heating and cooling device (212). In the case where thermal modulation is unsuccessful or partially successful, thermal modulation may not be appropriate for treatment and other options may be explored (207).

In the event that it is decided to use the thermal modulation device, the patient or other user may be trained or instructed on the use of the device. Thermal modulation may be performed using a thermal block. Thermal blocks may include devices that use varying degrees of implantation, from fully external percutaneous systems to fully implantable systems. For example, the thermal block may include a heating device using a thermal energy probe, transcutaneous cooling and inductive powering, transcutaneous heating and cooling devices, or a fully implantable thermal system.

Also disclosed is a method of selecting an affected area for thermal energy transfer between thermal energy devices for reversible occlusion of an area around a nerve in a body, the method comprising mounting a heating element and/or a cooling element on or near the nerve in the body, inserting an electrically conductive gel or elastomer into the body around the heating element and/or the cooling element and possibly the affected area near the nerve.

Also disclosed herein is a method of selecting an affected zone for thermal energy transfer between thermal energy devices for reversible occlusion of a zone around an internal nerve, the method comprising mounting a heating element and/or a cooling element on or near the body, inserting an insulating gel or elastomer into the body surrounding the desired affected zone of the heating element and/or cooling element to concentrate a thermal mass between the desired affected zone (consisting of the heating element and/or cooling element and the nerve) and other zones of undesired temperature.

Methods of use, devices used, and use of sensor data such as temperature, pressure, time, and/or flow rate, and may include, but is not necessarily limited to, human input via a machine interface as input to a feedback loop or an algorithm providing algorithmic control that will control the output of the systems/devices described herein, including but not limited to pump flow rate or the temperature to which a Peltier electrode or other temperature control device is heated or cooled, to vary the temperature as desired by algorithmic control. The invention also includes other data sources from the wearable device such as heart rate, degree of sweating, heart function/performance, blood pressure, stress level or GPS, as non-exhaustive examples. Other sensors may be added to the device or included in the input to the system to optimally control nerve conduction. The present invention also includes algorithmic control of other outputs not specifically listed herein that affect the operation or performance of the device in any way.

Claims

1. A method for determining a configuration of a thermal energy device for reversible blockade of nerves in a patient for the patient, comprising

Determining a depth of a nerve in a patient; and

determining whether the heating element and/or the cooling element of the thermal energy device should be implanted in or externally mounted on the body according to the following depth ranges:

for a depth range of zero to about 4 to 7mm, each of the heating element and the cooling element may optionally be externally mounted or implanted,

for a depth range of about 4 to 7mm to about 20 to 25mm, the heating element should be implanted and the cooling element may optionally be externally mounted or implanted, or

For a depth range of about 20 to 25mm or more, the heating element and cooling element should be implanted.

2. A method of reversibly blocking pain signals transmitted by nerves within a human body for reversible blockade, the method comprising

A heating element and/or a cooling element is mounted on or in the body in the vicinity of the nerve,

inserting a conductive polymer into the body between the heating element and/or the cooling element and the nerve, and

the heating element and/or the cooling element are activated.

3. A thermal energy system for reversible blockade of a nerve in a subject, the thermal energy system comprising

At least one heating element configured to be implanted in proximity to a nerve,

at least one cooling element configured to be placed externally on the subject's skin,

at least one feedback sensor configured to detect a temperature at or near the at least one location,

temperature controller, and

a system controller, the system controller and the temperature controller connected to a power source and in communication with a feedback sensor and configured to control a heating element and a cooling element.

4. A thermal energy system according to claim 3 wherein the system controller and temperature controller are configured to control the heating element and the cooling element based on a detected temperature received from the at least one temperature sensor and/or based on user input.

5. A thermal energy system according to claim 3 wherein the cooling element cools fluid conducted in one or more cooling fluid channels through the cooling element to the interface of the skin.

6. A thermal energy system according to claim 3 wherein the heating element is selected from the group consisting of resistive heating elements, inductive heating elements, Peltier heaters, microwave heating elements, radio frequency heating elements and infrared emitters.

7. A thermal energy system according to claim 6 wherein the heating element comprises a flexible portion comprising a resistive heating element powered by an induction coil receiving a radiated electromagnetic field, the flexible portion being connected to an internal control mechanism comprising a temperature controller, the temperature controller optionally being in wireless communication with the system controller.

8. A thermal energy system according to claim 3 wherein the heating element is heated by heated fluid received through the bellows from a heated fluid reservoir in fluid communication with a heated fluid pump controlled by the system controller.

9. A complete external thermal energy system for reversible blockade of a nerve of a subject, the complete external thermal energy system comprising:

at least one heating element configured to be placed externally on the skin of a subject,

at least one cooling element configured to be placed externally on the skin of a subject,

at least one feedback sensor capable of detecting a temperature near the nerve or at or near at least one location in the system,

temperature controller, and

a system controller connected to a power source, to the at least one feedback sensor and to a temperature controller, the system controller and the temperature controller configured to control the heating element and the cooling element to transition in temperature between a heating phase enabled by the heating element and a cooling phase enabled by the cooling element.

10. A complete external thermal energy system according to claim 9 wherein the transition between the heating phase and the cooling phase occurs in less than one minute.

11. An external thermal energy system according to claim 9 wherein the cooling stage is in the range 0 ℃ to 15 ℃.

12. A complete external thermal energy system according to claim 9 wherein the cooling stage is in the range of 15 ℃ to 35 ℃.

13. A total external thermal energy system according to claim 9 wherein the system is contained within a head harness, wherein the at least one heating element and the at least one cooling element are positioned on the subject's head in the vicinity of the occipital nerve.

14. A method of reversibly blocking a nerve in a subject by any one of the systems of claims 9-13 by all external means.

15. A thermal energy system for reversible blockade of a nerve in a subject, the thermal energy system comprising

at least one cooling element configured to be implanted in proximity to a nerve,

at least one feedback sensor configured to sense a temperature detected proximate to the at least one location,

the control unit of the external system is provided with,

temperature controller, and

a power supply connected to the external system controller and the temperature controller,

the feedback sensor communicates the sensed temperature to an external system controller and a temperature controller, and the external system controller and the temperature controller are configured to control a heating element and a cooling element.

16. A thermal energy system according to claim 15 wherein the external system controller and the temperature controller are configured to control the heating element and the cooling element based on a detected temperature received from the at least one temperature sensor and/or based on user input.

17. A thermal energy system according to claim 15 wherein the heating element and/or the cooling element is connected to an external system controller by a percutaneous line.

18. A thermal energy system according to claim 15 wherein the heating element is cooled by a cooled fluid and/or the heating element is heated by a heated fluid and/or the cooling element is cooled by a cooled fluid, said fluid being received via a percutaneous tube from at least one fluid reservoir, said at least one fluid reservoir being in fluid communication with at least one fluid pump controlled by an external system controller.

19. A thermal energy system according to claim 15 wherein the system controller receives and processes a biological signal of the subject from the at least one feedback sensor.

20. A fully implantable thermal energy system for reversible blockade of nerves in a subject, the fully implantable thermal energy system comprising:

at least one feedback sensor capable of detecting a temperature proximate to the at least one location,

a temperature controller and a system controller connected to the power source and configured to control the heating element and the cooling element.

21. A thermal energy system according to claim 20 wherein the system controller and temperature controller are configured to control the heating element and the cooling element based on a detected temperature received from the at least one temperature sensor and/or based on user input.