JP2021528151A - Systems and methods for thermal blockade of nerves - Google Patents

Abstract

The present disclosure generally relates to systems and methods for the reversible blockade of nerves using thermal energy, including heating and cooling. The heating and / or cooling elements may be implanted with additional components of the system provided outside the body. The system can be fully implantable or completely extracorporeal.
[Selection Diagram] FIGS. 5A and 5B.

Description

[0001] This application is entitled "Devices, Uses and Methods for Reversible Nerve Block at Moderate Temperature" and has priority over US Provisional Patent Application No. 62 / 686,712 filed June 19, 2018. Alleged, the content of which is incorporated herein by reference in its entirety.

[0002] This application is entitled "Device and Method for Nerve Block by Local Cooling to Room Temperature," and also includes the PCT application PCT / US Patent Application Publication No. 2016/064364 filed on December 1, 2016. Incorporated by reference as a whole.

Statement on federal-sponsored research or development
[0003] The present invention has been made with government support under DK068566, DK094905, DK102427 and DK111382 awarded by the National Institutes of Health. The government has certain rights to the invention.

[0004] The field of the present invention is reversible nerve blockade by thermal energy in human and animal subjects.

[0005] The present disclosure may be better understood with reference to the drawings below. The elements of the drawings are not necessarily scaled to each other and are emphasized to articulate the principles of the present disclosure. In addition, similar reference numerals specify corresponding parts through several figures.

[0006] FIG. 3 is a block diagram illustrating an exemplary embodiment of a thermal energy system for reversible blockade of nerve conduction. [0006] FIG. 3 is a block diagram illustrating an exemplary embodiment of a thermal energy system for reversible blockade of nerve conduction. [0007] FIG. 6 is a block diagram illustrating an additional exemplary embodiment of a thermal energy system for reversible blockade of nerve conduction. [0008] An exemplary thermal energy system for reversible blockade of nerve conduction is shown. [0008] An exemplary thermal energy system for reversible blockade of nerve conduction is shown. [0008] An exemplary thermal energy system for reversible blockade of nerve conduction is shown. [0009] FIG. 3 is a block diagram illustrating another exemplary embodiment of a thermal energy system for reversible blockade of nerve conduction. [0010] FIG. 4 is an image of another exemplary thermal energy system for reversible blockade of nerve conduction, as shown in FIG. [0010] FIG. 4 is an image of another exemplary thermal energy system for reversible blockade of nerve conduction, as shown in FIG. [0011] Show an exemplary effect of distance on heated or cooled nerve or tissue temperature, as can be brought about by a thermal energy system. [0011] Show an exemplary effect of distance on heated or cooled nerve or tissue temperature, as can be brought about by a thermal energy system. [0012] Show an exemplary insertion sheath such as that of the embodiment shown by FIG. 5A, which can be used to assist in the implantation of components of a thermal energy system. [0013] FIG. 6 is a perspective rear view of an exemplary fluid neural interface without a connection to a fluid tube. [0014] FIG. 6 is a cross-sectional view of an embodiment of an exemplary fluid nerve interface as shown in FIG. 8 around a nerve surrounded by a conductive gel, further surrounded by insulation. [0015] FIG. 6 is an additional cross-sectional view of an embodiment of an exemplary fluid nerve interface as shown in FIG. [0015] FIG. 6 is an additional cross-sectional view of an embodiment of an exemplary fluid nerve interface as shown in FIG. [0016] A schematic perspective front view of an exemplary fluid nerve interface, as shown in FIG. 8, around a nerve, with fluid channels extending posteriorly. [0017] FIG. 6 is a perspective view of an exemplary fluid nerve interface as shown in FIG. 8 with a fluid tube attached. [0017] FIG. 6 is a perspective view of an exemplary fluid nerve interface as shown in FIG. 8 with no fluid tube attached. [0018] Part of a flowchart illustrating exemplary methods for applying blocking embodiments as described herein. [0018] Part of a flowchart illustrating exemplary methods for applying blocking embodiments as described herein. [0018] Part of a flowchart illustrating exemplary methods for applying blocking embodiments as described herein.

[0019] Detailed description
[0020] The present invention relates to a set of methods and devices for thermally regulating nerves in the human or other mammalian body. The present invention may be particularly helpful in reversible blocking of chronic pain.

[0021] The embodiments of the present disclosure are illustrated by way of illustration in FIGS. It should be noted that in the present specification, all terms are given general meanings as known in the art and as further described and discussed in detail below. In the present specification and the following claims, many terms defined as having the following meanings are referred to.

[0022] In the present specification, the singular forms "one (a)", "one (an)" and "that" include a plurality of referents unless there is an explicit referent in the context.

[0023] As used herein, the range may be expressed as "about" from one particular value and / or "about" another particular value. When represented in such a range, embodiments include from one particular value to and / or from the other. Similarly, it is understood that a particular value forms another embodiment when the value is expressed as an approximation by using "about". It is understood that each end point of the range is significant both in relation to the other end point and independently of the other end point. It is also understood that there are several values disclosed herein, and each value is also disclosed herein as "about" that particular value, in addition to that value itself. For example, when the value "50" is disclosed, "about 50" is also disclosed.

[0024] As used herein, "moderate cooling" means cooling to a level below body temperature and for a duration, where any possible nerve damage is considered reversible. For example, moderate cooling includes cooling at temperatures ranging from about 15 ° C to about 30 ° C.

[0025] As used herein, "moderate heating" means heating to a level above body temperature and for a duration, where any possible nerve damage is considered reversible. For example, moderate heating may include heating at temperatures ranging from about 42 ° C to about 48 ° C for a duration of about 5-10 minutes or less.

[0026] As used herein, "reversible" is the ability of a partially or completely blocked nerve to regain most of its useful neural function within a period of approximately one month after treatment that induces blocking. Means. By this definition of "reversible", ablation is not considered reversible.

[0027] As used herein, the term "treatment" or "treat" includes any desired effect on a symptom or condition of a disease or condition and is measurable for one or more of the diseases or conditions being treated. May include a minimal reduction in the number of markers. "Treatment" does not necessarily indicate complete eradication or cure of the disease or condition or its associated symptoms.

[0028] As used herein, the term "patient" or "subject" includes any mammal, including humans.

[0029] As used herein, the terms "communicate," "communicate," or "communicate" refer to transmitting, sending, transmitting, and receiving data, including signals, inputs, commands, and outputs. Point to. A device, component or system may communicate with another or some other device, component or system either directly by physical connection or indirectly by wireless transmission or the like. The data to be communicated can be converted, rewritten or otherwise processed between devices, components or systems. The terms "communicate," "communicate," or "communicate" transfer fluid from one or several devices, components or systems to another or some other device, component or system. It can further refer to moving, circulating, or moving. Any electronic communication means or fluid communication means known in the art will be considered.

[0030] As used herein, nerve "blocking" refers to a situation in which a neuron does not propagate action potentials or has a small amplitude evoked action potential. Nerve blockade is partial when a lower percentage of neurons propagate action potentials than unblocked neurons or when the amplitude of the evoked action potential is less than the amplitude of the action potential evoked by the unblocked neurons. Can be the target.

[0031] In the present specification, the "internal" part of a component, device or system relates to the human body. For example, an internally located device may be located within the patient's body, i.e. below the patient's skin.

[0032] In the present specification, a component, device or system "external" section relates to the human body. For example, externally located devices may be located outside the patient's body or above the patient's body, rather than within the patient's body or below the patient's skin.

[0033] In a plurality of embodiments, the present specification provides methods and devices for reversibly stimulating and / or blocking nerves by thermal regulation. Nerve block is associated with, but not limited to, occipital nerves for treating occipital nerve pain, saphenous nerves associated with chronic severe knee pain following total knee arthroplasty, and degenerative arthritis. One or more intra-articular areas of the knee to reduce pain, posterior root ganglion and other areas of the spinal cord for chronic intense pain, incisions to treat postoperative pain following treatment Any area along or around the aching wound or the median nerve, iliac nerve, tibia nerve, sciatic nerve, intercostal nerve, peroneal nerve, femoral nerve, axillary nerve, supraclavicular nerve, peroneal abdominal nerve, ulnar bone It can be useful in the treatment of many conditions, including blocking and / or stimulating nerves, radial nerves, lateral femoral cutaneous nerves or any other nerve responsible for pain. Other exemplary uses of this method and device are the treatment of obesity in patients by blocking the abdominal stray nerve branches, sympathetic nerves and optionally one or more of the large visceral nerves, visceral nerves or sympathetic nerve stems. Treatment of patient's heart failure by blocking the pudendal nerve, treatment of patient's urinary obstruction by blocking the pudendal nerve, treatment of patient's muscle spasm by nerve-controlling nerve, treatment of patient's cardiovascular disease by stray nerve and occipital Includes treatment of occipital or migraine in patients with nerves. The methods and devices are conceivable for the use of monitoring, diagnosis or treatment of any such condition or disease in which the nerve block is suitable for the analysis, identification or management of the condition or disease or its symptoms.

[0034] In one embodiment, thermal regulation is selected from the group consisting of nerve heating only, cooling only, alternating heating and cooling, or simultaneous heating and cooling. Illustrative methods and equipment for heating only, cooling only, and alternating heating and cooling are described herein.

[0035] In some embodiments, the reversible thermal blockade achieved by the present invention can be achieved by moderately heating a defined section of the nerve and then moderately cooling. It is well known that extreme heating or cooling of a nerve over a longer duration can cause irreversible damage to that nerve. For example, temperatures above about 50 ° C and below about 5 ° C have been used in the art known methods for single temperature nerve blocks. However, applying these extreme temperatures to nerves can cause permanent damage within minutes or hours.

[0036] The initial heating step may increase the cooling temperature applied to cause complete or partial nerve blockage than is possible or acceptable by other methods without the initial heating step. .. The present invention can avoid the use of extreme temperatures that potentially induce permanent damage by combining an initial modest heating step followed by a modest cooling step. Nerve blockade includes situations in which neurons treated according to or using the Instrument do not propagate action potentials, or a lower percentage of neurons propagate action potentials than unblocked neurons.

[0037] The present invention may affect nerves at a safe temperature at which irreversible nerve damage is avoided, at least in part. The present invention initially relates to these by heating the nerve at a moderate temperature that is above body temperature for a duration but below a temperature that can cause irreversible damage to the nerve over that duration. The use of temperatures that cause extreme and potentially damage can be avoided. During moderate heating, nerve conduction can be partially or completely reduced, and nerves can be observed to have partially or completely reduced evoked action potentials or signals. Following moderate heating of the nerve, moderate cooling can be performed at a temperature below body temperature for a duration, but above the temperature at which irreversible damage can occur on the nerve over that duration. During moderate cooling, the temperature can be kept at the cooling temperature or lowered in a series of steps to lower the cooling temperature. The steps can be of equal or different duration and of equal or different temperature magnitude. The transition between the heating phase and the cooling phase can occur in less than about 1 minute, about 1 minute to about 3 minutes, or about 3 minutes to about 5 minutes. In one embodiment, the temperature transition between the heating phase and the cooling phase can occur in about 5 to about 25 minutes. In one embodiment, the temperature transition between the heating phase and the cooling phase can occur in about 25 to about 60 minutes.

[0038] In one embodiment, the cooling phase is in the range of about −5 ° C. to about 0 ° C. In one embodiment, the cooling phase is in the range of about 0 ° C to about 15 ° C. In one embodiment, the cooling phase is in the range of about 15 ° C to about 35 ° C. In one embodiment, the heating phase is in the range of about 40 ° C to about 51 ° C. In one embodiment, the heating phase is in the range of about 43 ° C to about 48 ° C.

[0039] In the embodiments described in FIGS. 1A-1B, the thermal energy system (105, 305, 505) is located outside the patient, implanted in the patient, or neural for thermal regulation. It may have components located outside and inside the location above or near it. As shown in FIG. 1A, the thermal energy system (105, 305, 505) may include a combination of internal and external components. In one embodiment, the combination of internal and external components can be used for heating, cooling, alternating heating and cooling of nerves, or simultaneously heating and cooling. In one embodiment, the thermal energy system (105, 305, 505) as in FIG. 1A has at least one heating element (108, 308, 515) and at least one cooling element (107) implanted near the nerve. , 307), a temperature controller (106, 306) including at least one feedback sensor (110, 310, 516), eg, a temperature sensor capable of detecting a temperature near at least one location in one embodiment, and a power supply. It may include an external system controller (109, 309, 510) connected to. The internal temperature controller (106, 306) is at least one heating element (108, 308, 515), at least one cooling element (107, 307) and, in one embodiment, a temperature sensor, etc., as shown in FIG. 1A. It may include one feedback sensor (110, 310, 516). In one embodiment, the system controller (109, 309, 510) may include a processor (111, 311, 522) and may communicate with an internal temperature controller (106, 306), the internal temperature controller being at least one. The temperature of the heating element (108, 308, 515) and at least one cooling element (107, 307) can be controlled, and information can be received by a signal from at least one feedback sensor (110, 310, 516). The temperature can be adjusted by the system controller (109, 309, 510) based on the signal received from at least one feedback sensor (110, 310, 516) including the temperature sensor.

[0040] In one embodiment, at least one heating element (108, 308, 515) is an electrical resistance heating element, an induction heating element, a perche heater, a microwave heating element, a high frequency heating element and an infrared emitter or a nerve thermal control. It can be any other suitable heating means capable of providing the required heating temperature and duration in the modest heating step in. In one embodiment, at least one cooling element (107, 307) is the cooling temperature and duration required for a modest cooling step in the thermal regulation of cooling tubes, thermoelectric coolers, refrigeration systems, Pelce coolers, ice or nerves. Can be any other suitable cooling means that can result in. In one embodiment, the feedback sensors (110, 310, 516) block or partially block the thermocouple, thermistor or nerve, so that the temperature of the nerve before, during and after heat regulation. Any other suitable device or material that can monitor changes. Feedback sensors (110, 310, 516), such as temperature sensors, are in or near at least one heating element (108, 308, 515) or at least one cooling element (107, 307), or in or near the body. It can be placed elsewhere on the device or elsewhere in the device.

[0041] In one embodiment, at least one heating element (108, 308, 515) may include an electrical resistance heating element fed by inductive means. The electric resistance heating element may include a flexible portion including at least one electric resistance heating element fed by an induction coil that receives the radiated electromagnetic field, and the flexible portion is connected to an internal control mechanism. The internal control mechanism may further include a temperature controller (106, 306) that can optionally wirelessly communicate with the system controller (109, 309, 510). The system controller (109, 309, 510) may be internal or external in different embodiments.

[0042] In one embodiment, at least one feedback sensor (110, 310, 516), eg, a temperature sensor capable of detecting temperature in one embodiment, is at least one heating element on or near the patient's skin. (108, 308, 515) Located on or near (108, 308, 515) at least one location selected from the group consisting of within or near one or more coolant channels or within or near a thermoelectric cooler. In one embodiment, the thermal energy system (105, 305, 505) is one or more feedback sensors (105, 305, 505) for monitoring various biomarkers or biological signals to correct the thermal energy directed at the nerve. 110, 310, 516) can be included. The system controller (109, 309, 510) may receive and process the biological signal of interest from at least one feedback sensor (110, 310, 516). In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, while the feedback sensor (110, 310, 516) is selected from the group consisting of temperature and chemical levels on or near the nerve. Biological signals can also be monitored. In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, whereas the feedback sensor (110, 310, 516) is a body temperature, blood pressure, heartbeat, time, sweating, oxygen saturation, electrocardiogram signal and / Or biological signals selected from the group consisting of any other such useful and suitable parameters of the patient's health, symptoms or comfort may also be monitored. In one embodiment, there are multiple feedback sensors (110, 310, 516) and their output signals are for software to control the cooling element (107, 307) and the heating element (108, 308, 515). It is received by the processor (111, 311, 522) of the temperature controller (106, 306) and / or the system controller (109, 309, 510) set in. The thermal energy system (105, 305, 505) is configured to communicate the parameters detected by the feedback sensors (110, 310, 516) with the system controller (109, 309, 510). In one embodiment, the thermal energy system (105, 305, 505) is the processor (111, 311, 522) or temperature controller (111, 311, 522) of the system controller (109, 309, 510) after implantation or external placement of the patient. It can be set by the clinician or user by selecting one or more parameters of the software or firmware of 106, 306). In another embodiment, the parameters can be preset. In one embodiment, the user can control communication with the system controller (109, 309, 510), where the user has a degree of pain, a degree of motor function, sensory sensitivity, including touching pain, sharpness. Input factors can be selected from the group consisting of temperature and stress level. The user may also control the system by "turning on" or "turning off" the power or changing the behavior at any level.

[0043] In one embodiment, the thermal energy system (105, 305, 505) may provide information to support an acceptable arrangement of the thermal energy system (105, 305, 505). In one embodiment, the thermal energy system (105, 305, 505) is acceptable for the thermal energy system (105, 305, 505) after partial or complete blockage of the nerve using a heating step followed by a cooling step. It can be set to support various placements. In this embodiment, the thermal energy system (105, 305, 505) is a sensory, body temperature, blood pressure, heartbeat, time, sweating, oxygen saturation, electrocardiographic signal, temperature and chemical levels on or near the nerve or of the patient. Acceptable arrangement of thermal energy systems (105, 305, 505) based on the effect on the patient, selected from the group containing any other such useful and suitable parameters of health, symptoms or comfort. Can be determined. In one embodiment, the arrangement of the thermal energy system (105, 305, 505) is user input from the group consisting of degree of pain, degree of motor function, sensory sensitivity including touching pain, sharpness, temperature and stress level. It can be further guided by factors. In one embodiment, the feedback loop is applied to the thermal energy system (105, 305, 505) based on the temperature detected by the feedback sensors (110, 310, 516), including, but not limited to, the temperature sensor. It can be used to control the power delivered.

[0044] The temperature controller (106, 306) controls the heating of at least one heating element (108, 308, 515), the cooling of at least one cooling element (107, 307), and monitors the temperature of the nerve. Therefore, it may be physically or wirelessly connected to a system controller (109, 309, 510) including a processor (111, 311, 522). The wireless power transfer means to at least one heating element (108, 308, 515) can be electromagnetic induction or microwave energy transfer.

[0045] In one embodiment, the thermal energy system (105, 305, 505) is powered by a power source, where the power sources are an internal primary battery, an internal (rechargeable) secondary battery, and electromagnetically induced power. It is selected from the group consisting of transmission, wireless power transfer including microwave radio transmission, invisible laser power transfer, AC current, and kinetic energy harvesting system.

[0046] In one embodiment, as shown in FIG. 2, the temperature controller (106, 306) provides percutaneous wires and / or tubes (312) or other suitable connecting means through the open skin. It can be connected to the patient, such as by use, to control the internal components of the temperature controller (106, 306). In this embodiment of the thermal energy system (105, 305, 505), the percutaneous wire and / or tube (312) is heated from an external system controller (109, 309, 510) including a processor (111, 311, 522). It can be connected to at least one of the elements (108, 308, 515) or the cooling element (107, 307), and at least one feedback sensor (110, 310, 516) can communicate with the processor (111, 311, 522). .. In one embodiment, at least one heating element (108, 308, 515) and / or at least one cooling element (107, 307) can be controlled by the power received from the percutaneous wire (312) to the power source. ..

[0047] In various embodiments, such as those shown in FIGS. 1A-1B, fluid transport may achieve heating and cooling temperatures exactly as directed by the system controller (109, 309, 510). Can be used to transfer the thermal energy of the thermal energy system (105, 305, 505). In one embodiment, the heat pipe is the heat of the thermal energy system (105, 305, 505) so that the heating and cooling temperatures can be achieved exactly as directed by the system controller (109, 309, 510). It is used to convey energy. The heat pipe can be flexible and can be made of a biocompatible material.

[0048] In one embodiment, at least one of the at least one heating element (108, 308, 515) or at least one cooling element (107, 307) is a channel (113) for circulating the heated or cooled fluid. ) Can be included. In one embodiment, the heated fluid tank (114) can communicate with the channel (113) to circulate the heated fluid. In one embodiment, the cooling fluid tank (115) can communicate with the channel (113) to circulate the cooling fluid. The heating fluid tank (114), the cooling fluid tank (115) or the regenerating fluid tank (512) can rapidly raise or lower the temperature of the fluid in the tank, and the fluid is a system controller (109, 309). Allows circulation to result in heating and cooling of the nerves as directed by 510). FIG. 1A shows a channel (113) for communicating a cooling fluid to a cooling fluid tank (115) connected to at least one cooling element (107, 307), which is an exemplary embodiment. Yes, other channel configurations as described herein are possible. For example, the channel (113) of FIG. 1A may be connected to at least one heating element (108, 308, 515) to allow the heating fluid to communicate with the heating fluid tank (114). In one embodiment, as described in FIG. 2, at least one heating element (108, 308, 515) is at least one fluid pump and fluid controlled by an external system controller (109, 309, 510). Heated by a heating fluid received through a percutaneous tube (312) from at least one communicating fluid tank and / or at least one cooling element (107, 307) by an external system controller (109, 309, 510). It is cooled by a cooling fluid received through a percutaneous tube (312) from at least one fluid tank that communicates with at least one controlled fluid pump.

[0049] In one embodiment, the rapid rise or fall of the temperature of the fluid in the heated fluid tank (114) and / or the cooling fluid tank (115) is described in US Pat. No. 9,283,109 (see in its entirety). It can be done using a hyperthermia device similar to that described in (incorporated herein by). The device may further include a heat exchanger that heats and / or cools the fluid and a pump for the transfer of the heated or cooled fluid. Other heat exchange mechanisms capable of rapidly heating or cooling the fluid in the heating fluid tank (114) and / or the cooling fluid tank (115) are considered in the present invention. The rapid rise or fall may include a temperature change of about 1 to about 10 ° C. over a time of about 60 minutes, 25 minutes, 5 minutes, about 3 minutes or less, or preferably about 1 minute or less.

[0050] The thermal energy system (105, 305, 505) can be described by FIGS. 3A-3C, where FIG. 3A is relative to the tip of a standard pencil, the thermal energy system (105, 305, 505). The relative size of the implantable temperature controller (106, 306) of one embodiment of 505) is shown. FIG. 3B shows a diagram of implantable components surrounding the target nerve. FIG. 3C shows details of the implantable components of the thermal energy system (105, 305, 505) located on or near the 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 multiple parts of the device that are not adjacent to the nerve, the insulating material (104) surrounds the conductive material (103), limiting the transfer of thermal energy to the nerve and transferring thermal energy to the non-target nerve. To avoid. The entire device or a portion thereof may be coated with a biocompatible coating (102) and the thermal energy system (105, 305, 505) nerves for the duration required for treatment without triggering a significant immune response. Allow it to be planted on or near. In one embodiment, the at least one heating element (108, 308, 515) and the at least one cooling element (107, 307) are horseshoe, C-shaped, bowl and semicircular as illustrated in FIGS. 3B-3C. It is composed of a shape including a circular shape. In one embodiment, the thermal energy system (105, 305, 505) is constructed of biocompatible material or comprises a biocompatible coating on at least one segment of the device. The biocompatible coating is a gel, airgel, hydrogel, microparticles, dermal filler 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. obtain. 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) following implantation. The biocompatible coating can be biodegradable and can decompose over a finite period of time. The degradation may not occur in vivo or may only degrade slowly in vivo over a long period of time, such as months or years.

[0051] In one embodiment, the thermal energy system (105, 305, 505) is completely external and, as shown in FIG. 1B, with at least one heating element (108, 308, 515) and at least one. One cooling element (107, 307), a system controller (109, 309, 510) including a processor (111, 311, 522), and at least one feedback sensor (110, 310, 516), such as a temperature sensor, in one embodiment. ) And the temperature controllers (106, 306) including. In one embodiment, the thermal energy system (105, 305, 505) is an external thermal energy system (105, 305, 505) for reversibly blocking the nerve of interest. The external thermal energy system (105, 305, 505) has at least one heating element (108, 308, 515) and / or at least one cooling element (107, 307) connected to a power supply and temperature controller (106, 306). ), A system controller (109, 309, 510), and at least one feedback sensor (110, 310, 516), such as a temperature sensor capable of detecting temperature on or near at least one location in one embodiment. It may include temperature controllers (106, 306) including. The external thermal energy system (105, 305, 505) has a heating phase enabled by at least one heating element (108, 308, 515) and cooling enabled by at least one cooling element (107, 307). It may be configured to make a temperature transition with the phase.

[0052] In one embodiment, the at least one heating element (108, 308, 515) is an electrical resistance heating element, an induction heating element, a perche heater, a microwave heating element, a high frequency heating element, an infrared emitter or a nerve thermal control. It can be any other suitable heating means capable of providing the required heating temperature and duration in the modest heating step in. In one embodiment, at least one cooling element (107, 307) provides the required cooling temperature and duration in a moderate cooling step in cooling tubes, thermoelectric coolers, refrigeration systems, Pelce coolers, ice or nerve thermal regulation. It can be any other suitable cooling means that can be used. In one embodiment, the feedback sensors (110, 310, 516) change the temperature of the nerve before, during and after heat regulation to block or partially block the thermocouple, thermistor or nerve. Any other suitable device or material capable of monitoring. Feedback sensors (110, 310, 516), such as temperature sensors, are in or near at least one heating element (108, 308, 515) or at least one cooling element (107, 307), or in or near the body. It may be placed elsewhere on the device or elsewhere in the device.

[0053] In one embodiment, the at least one heating element (108, 308, 515) of the thermal energy system (105, 305, 505) is fed by an induction coil that receives a radiated electromagnetic field. It is an electric resistance heating element including a flexible portion including, where the flexible portion is connected to an internal control mechanism. The internal control mechanism may optionally include a temperature controller (106, 306) capable of wirelessly communicating with the system controller (109, 309, 510).

The temperature controller (106, 306) is physically or optionally wirelessly connected to the system controller (109, 309, 510) including the processor (111, 311, 522) to provide at least one heating. It is possible to control the heating of the element (108, 308, 515), the cooling of at least one cooling element (107, 307), and monitor the temperature of the nerve. The processor (111, 311, 522) may execute programming instructions that may be stored in the memory of the temperature controller (106, 306). The external thermal energy system (105, 305, 505) may include wireless power transfer to at least one heating element (108, 308, 515), where the wireless power is electromagnetic induction or microwave energy transfer. ..

The thermal energy system (105, 305, 505) and the system controller (109, 309, 510) are powered by a power source. The power supply is an internal primary battery, an internal secondary (rechargeable) battery, wireless power transmission including electromagnetic induction wireless power transmission and microwave wireless power transmission, invisible laser power transmission, AC current, and kinetic energy. It can be selected from a group consisting of a harvesting system.

[0056] In one embodiment, the fully external thermal energy system (105, 305, 505) is all subject to external means, using all or combinations of the components of the external thermal energy system (105, 305, 505). It can be used to provide a method of reversible blockade of nerves in the body. In one embodiment, the thermal energy system (105, 305, 505) is in medical treatment lasting about minutes, hours or days or years to treat a chronic condition or symptom, 1 It can reversibly block one or more nerves.

[0057] In one embodiment, the thermal energy system (105, 305, 505) is fully implantable and, as shown in FIG. 1B, with at least one heating element (108, 308, 515) and at least. One cooling element (107, 307), a system controller (109, 309, 510) including a processor (111, 311, 522) and, in one embodiment, at least one feedback sensor (110, 310, such as a temperature sensor). It may further include temperature controllers (106, 306) including 516) and. In one embodiment, the thermal energy system (105, 305, 505) is an implantable thermal energy system (105, 305, 505) for reversibly blocking the nerve of interest. Fully implanted thermal energy systems (105, 305, 505) include at least one heating element (108, 308, 515) and / or at least one cooling element (107, 307) implanted near or above the nerve. ), At least one feedback sensor (110, 310, 516), such as a temperature sensor capable of detecting temperature in one embodiment, near at least one location, and a processor (111, 516) connected to a power source. It may include a temperature controller (106, 306) including a system controller (109, 309, 510) including 311, 522).

[0058] In one embodiment, at least one heating element (108, 308, 515) is an electrical resistance heating element, an induction heating element, a perche heater, a microwave heating element, a high frequency heating element, an infrared emitter or a nerve thermal control. It can be any other suitable heating means capable of providing the required heating temperature and duration in the modest heating step in. In one embodiment, at least one cooling element (107, 307) can provide the required cooling temperature and duration in a moderate cooling step in a cooling tube, thermoelectric cooler, refrigeration system, Pelce cooler or neural thermal regulation. It may be another suitable cooling means. In one embodiment, the feedback sensors (110, 310, 516) change the temperature of the nerve before, during and after heat regulation to block or partially block the thermocouple, thermistor or nerve. Any other suitable device or material capable of monitoring. Feedback sensors (110, 310, 516), such as temperature sensors, are in or near at least one heating element (108, 308, 515) or at least one cooling element (107, 307), or on the body or body. It may be located elsewhere, or elsewhere in the device. In one embodiment, the at least one heating element (108, 308, 515) of the thermal energy system (105, 305, 505) may include at least one resistance heating element fed by an induction coil that receives a radiated electromagnetic field. An electrical resistance heating element that includes a flexible portion, where the flexible portion is connected to an internal control mechanism. The internal control mechanism may optionally include a temperature controller (106, 306) capable of wirelessly communicating with the system controller (109, 309, 510). The system controller (109, 309, 510) may be internal or external in different embodiments.

[0059] The temperature controller (106, 306) controls the heating of at least one heating element (108, 308, 515), the cooling of at least one cooling element (107, 307), and monitors the temperature of the nerve. Therefore, it may be physically or optionally wirelessly connected to a system controller (109, 309, 510) including a processor (111, 311, 522). The processor (111, 311, 522) may execute programming instructions that may be stored in the memory of the temperature controller (106, 306). The thermal energy system (105, 305, 505) and the system controller (109, 309, 510) can be powered by a power supply. Wireless power transfer can occur between the power source and at least one heating element (108, 308, 515), where wireless power transfer includes electromagnetic induction or microwave energy transfer.

[0060] In one embodiment, the fully implanted thermal energy system (105, 305, 505) is subject to all by internal means, using all or combinations of the components of the internal thermal energy system (105, 305, 505). It can be used to provide a method of reversible blockade of nerves in the body. In one embodiment, the thermal energy system (105, 305, 505) is one during a medical procedure of about minutes, about hours or days or years to treat a chronic condition or symptom. Or it can reversibly block multiple nerves.

[0061] In various fully implantable or completely external embodiments, at least one feedback sensor (110, 310, 516), such as a temperature sensor capable of detecting temperature in one embodiment, is the patient's. At least one selected from the group consisting of on or near the skin, on or near at least one heating element (108, 308, 515), in or near one or more coolant channels, or in or near a thermoelectric cooler. Can be located in one place. In one embodiment, the thermal energy system (105, 305, 505) is one or more feedback sensors (105, 305, 505) for monitoring various biomarkers or biological signals to correct the thermal energy directed at the nerve. 110, 310, 516) can be included. The system controller (109, 309, 510) may receive and process the biological signal of interest from at least one feedback sensor (110, 310, 516). In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, while the feedback sensor (110, 310, 516) is selected from the group consisting of temperature and chemical levels on or near the nerve. Biological signals can also be monitored. In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, whereas the feedback sensor (110, 310, 516) is a body temperature, blood pressure, heartbeat, time, sweating, oxygen saturation, electrocardiogram signal and / Or biological signals selected from the group consisting of any other such useful and suitable parameters of the patient's health, symptoms or comfort may also be monitored. In one embodiment, there are multiple feedback sensors (110, 310, 516) whose output signals are the processor (111, 311) of the temperature controller (106, 306) and / or the system controller (109, 309, 510). Received by 522), these are set up for software to control the cooling elements (107, 307) and the heating elements (108, 308, 515). The thermal energy system (105, 305, 505) is structured to communicate the parameters detected by the feedback sensors (110, 310, 516) with the system controller (109, 309, 510). In one embodiment, the thermal energy system (105, 305, 505) is the processor (111, 311, 522) or temperature controller (106) of the system controller (109, 309, 510) after implantation or external to the patient. , 306), which can be set by the clinician or user by selecting one or more parameters in the software or firmware. In another embodiment, the parameters can be preset. In one embodiment, the thermal energy system (105, 305, 505) may include user-controlled communication with a system controller (109, 309, 510), wherein the user is in a degree of pain, a degree of motor function, and the like. Input factors can be selected from the group consisting of sensory sensitivity, sharpness, temperature and stress levels, including touching pain. The user may also control the system by "turning on" or "turning off" the power or changing the behavior at any level.

[0062] In one embodiment, the thermal energy system (105, 305, 505) may provide information to support an acceptable arrangement of the thermal energy system (105, 305, 505). In one embodiment, the thermal energy system (105, 305, 505) is acceptable for the thermal energy system (105, 305, 505) after partial or complete blockage of the nerve using a heating step followed by a cooling step. It can be set to support various placements. In this embodiment, the thermal energy system (105, 305, 505) is a body temperature, blood pressure, heartbeat, time, sweating, oxygen saturation, electrocardiographic signal, temperature and chemical levels on or near the nerve and / or the patient's. An acceptable arrangement of thermal energy systems (105, 305, 505) based on the effect on the patient selected from the group containing any other such useful and suitable parameters of health, symptoms or comfort. Can be decided. In one embodiment, the arrangement of the thermal energy system (105, 305, 505) is user input from the group consisting of degree of pain, degree of motor function, sensory sensitivity including touching pain, sharpness, temperature and stress level. It can be further guided by factors. In one embodiment, the feedback loop is applied to the thermal energy system (105, 305, 505) based on the temperature detected by the feedback sensors (110, 310, 516), including, but not limited to, the temperature sensor. It can be used to control the power delivered.

[0063] In various fully implantable or completely external embodiments, such as those described in FIG. 1B, the fluid transport is heated as directed by the system controller (109, 309, 510). And can be used to transfer the thermal energy of the thermal energy system (105, 305, 505) so that the cooling temperature can be achieved accurately. In one embodiment, the heat pipe is the heat of the thermal energy system (105, 305, 505) so that the heating and cooling temperatures can be achieved exactly as directed by the system controller (109, 309, 510). Used to transfer energy. The heat pipe can be flexible and can be made of a biocompatible material.

[0064] In one fully implantable or completely external embodiment, at least one of at least one heating element (108, 308, 515) or at least one cooling element (107, 307) is heated or cooled. It may include a channel (113) for circulating the cooled fluid. In one embodiment, the heated fluid tank (114) can communicate with the channel (113) to circulate the heated fluid. In one embodiment, the cooling fluid tank (115) can communicate with the channel (113) to circulate the cooling fluid. Since the heating fluid tank (114), the cooling fluid tank (115) or the regenerating fluid tank (512) can rapidly raise or lower the temperature of the fluid in the tank, the fluid is a system controller (109, 309, It can be circulated to provide heating and cooling of the nerve as instructed by 510). FIG. 1B shows a channel (113) for communicating a heating fluid to a heating fluid tank (114) connected to at least one heating element (108, 308, 515), which is an exemplary practice. It is a form, and other channel forms as described herein are possible. For example, the channel (113) of FIG. 1B may be connected to at least one cooling element (107, 307) to allow the cooling fluid to communicate with the cooling fluid tank (115).

[0065] In some embodiments, the thermal energy system (105, 305, 505) is completely non-invasive and is externally located or fully implantable. At least one heating element (108, 308, 515) and at least one cooling element (107, 307) may include channels (113) communicating with the heating fluid tank (114) and the cooling fluid tank (115), respectively. .. The heating fluid tank (114) and the cooling fluid tank (115) may allow the fluid temperature to rise or fall rapidly as instructed by the system controller (109, 309, 510). The rapid rise or fall may include a temperature change of about 1 to about 10 ° C. over a time of about 5 minutes, about 3 minutes or less, or preferably about 1 minute or less. In one embodiment, a rapid rise or fall in the temperature of the fluid in the heated fluid tank (114) or the cooling fluid tank (115) is described herein in its entirety by US Pat. No. 9,283,109. It can be done using a hyperthermia device similar to that described in (Incorporated). The device may further include a heat exchanger that heats and / or cools the fluid and a pump for moving the heated or cooled fluid. Other heat exchange mechanisms capable of rapidly heating or cooling the fluid in the heating fluid tank (114) and the cooling fluid tank (115) are considered in the present invention.

[0066] In one embodiment, a hot fluid ranging from about 112 ° F to about 118 ° F is generated in the heating fluid tank (115) and is transported from there to at least one heating element (108, 308, 515). Therefore, the externally applied heating fluid provides moderate heating to the nerves as instructed by the system controller (109, 309, 510). In one embodiment, a hot fluid ranging from about 112 ° F to about 114 ° F is generated in the heating fluid tank (115) and is transported from there to at least one heating element (108, 308, 515). The externally applied heating fluid provides an initial modest heating to the nerve as directed by the system controller (109, 309, 510). After that, a hot fluid ranging from about 115 ° F to about 117 ° F is generated in the heating fluid tank (115) and can be transported from there to at least one heating element (108, 308, 515), so that it is added from the outside. The heated fluid provided can result in a modest increase in heating to the nerves as directed by the system controller (109, 309, 510). The thermal energy system (105, 305, 505) is arranged in direct contact with the patient's skin or is thermally conductive to facilitate the transfer of thermal energy from the thermal energy system (105, 305, 505) to the patient. May include a gel layer.

[0067] Thermally conductive gels, self-curing polymers, foams, plastics or other biocompatible polymers or composites can be injected or inserted into the body, where the gel or material is the area between the device and the target nerve. By increasing the thermal conductivity and the thermal energy transfer rate in, the performance of the thermal energy system (105, 305, 505) may be enhanced. A thermally conductive gel or material can spread thermal energy over longer distances than would otherwise be spread, allowing many nerves to receive thermal energy. This spread of thermal energy can be useful in multiple locations, such as in the intra-knee region, or can thermally regulate the nerve along the surgical incision site. Thermally conductive gels, foams or other carrier materials are generally made by combining a base polymer with a thermally conductive filler. Base polymers may include hydrogels and silicones, including gels that are injected at room temperature and at that location cure to their final shape by body temperature. Fillers are graphites as commonly used to provide thermally conductive polymers with thermal conductivity in the range of 1-40 W / mK, such as CoolPoly-D, CoolPoly Elastomers and CoolPoly-E materials commercially available by Celanese. , Carbon fiber and ceramic may be included. Other thermally conductive gels or materials are considered for use in the present invention. The use of thermally conductive gels or materials can enhance the performance of thermal energy systems (105, 305, 505) by increasing the thermal conductivity and rate of thermal energy transfer between the device and the target nerve. A thermally conductive gel or material can spread thermal energy over longer distances than would otherwise be spread, thereby allowing more nerves to receive thermal energy. This spread of thermal energy can be useful in multiple locations, such as in the intra-knee region. Other thermally conductive gels or materials are considered for use in the present invention.

[0068] In one embodiment, a low temperature fluid ranging from about 6 ° C to about 10 ° C is generated in the cooling fluid tank (115) and transported to at least one cooling element (107, 307), so that it is added from the outside. The cooling fluid provided may provide adequate cooling to the nerves as directed by the system controller (109, 309, 510). In one embodiment, the cold fluid can be higher than about 0 ° C or about 0 ° C and can be raised in temperature in the range of about 6 ° C to about 10 ° C as desired for patient comfort.

[0069] In one embodiment, the thermally conductive material can be perfused near the nerve before blocking or partially blocking the nerve using heating and cooling steps. In one embodiment, the insulation can be perfused near the nerve before using the heating and cooling steps to block or partially block the nerve axons.

[0070] In one embodiment of the invention, as shown by the example of FIG. 4, the thermal energy system (105, 305, 505) is the at least one heating element (108) implanted near or above the nerve. , 308, 515), a cooling element (107, 307) externally located on the target skin, at least one temperature sensor capable of detecting a temperature near at least one location, and a power source or power source. Includes temperature controllers (106, 306) including system controllers (109, 309, 510) connected to the feeder.

[0071] In one embodiment, the at least one heating element (108, 308, 515) is an electrical resistance heating element, an induction heating element, a perche heater, a microwave heating element, a high frequency heating element, an infrared emitter or a nerve thermal control. It can be any other suitable heating means capable of providing the required heating temperature and duration in the modest heating step in. In one embodiment, at least one cooling element (107, 307) provides the required cooling temperature and duration in a moderate cooling step in cooling tubes, thermoelectric coolers, refrigeration systems, Pelce coolers, ice or nerve thermal regulation. It can be any other suitable cooling means that can be used. In one embodiment, the cooling elements (107, 307) cool the fluid carried to the interface for the skin in one or more coolant channels. In one embodiment, the feedback sensors (110, 310, 516) block or partially block the thermocouple, thermistor or nerve, so that the temperature of the nerve is before, during and after heat regulation. Any other suitable device or material that can monitor changes. The temperature sensor may be in or near the periphery of at least one heating element (108, 308, 515) or at least one cooling element (107, 307), or elsewhere in the body or body, or in equipment. Can be placed in the location of.

[0072] In one embodiment, at least one heating element (108, 308, 515) may include an electrical resistance heating element fed by inductive means. At least one heating element (108, 308, 515) of the thermal energy system (105, 305, 505) includes a flexible portion containing at least one resistance heating element fed by an induction coil that receives a radiated electromagnetic field. It can be an electric resistance heating element. In one embodiment, the flexible portion of the thermal energy system (105, 305, 505) may be connected to an internal control mechanism that includes a temperature controller (106, 306), wherein said temperature controller (106, 306). Can optionally communicate wirelessly with the system controller (109, 309, 510). The system controller (109, 309, 510) may be internal or external in different embodiments.

[0073] In one embodiment, at least one heating element (108, 308, 515) is heated by the power received from the percutaneous wire to the power source. In one embodiment, at least one heating element (108, 308, 515) was received through a percutaneous tube from a heating fluid tank that communicates fluid with a heating fluid pump controlled by a system controller (109, 309, 510). It is heated by the heating fluid.

[0074] In one embodiment, at least one feedback sensor (110, 310, 516), eg, a temperature sensor capable of detecting temperature in one embodiment, is at least one heating element on or near the patient's skin. (108, 308, 515) Located on or near (108, 308, 515) at least one location selected from the group consisting of within or near one or more coolant channels or within or near a thermoelectric cooler. In one embodiment, the thermal energy system (105, 305, 505) is one or more feedback sensors (110,) that monitor various biomarkers or biological signals to correct the thermal energy directed at the nerve. 310, 516) can be included. The system controller (109, 309, 510) may receive and process the biological signal of interest from at least one feedback sensor (110, 310, 516). In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, while the feedback sensor (110, 310, 516) is selected from the group consisting of temperature and chemical levels on or near the nerve. Biological signals can also be monitored. In one embodiment, the feedback sensor (110, 310, 516) is a temperature sensor, whereas the feedback sensor (110, 310, 516) is a body temperature, blood pressure, heartbeat, time, sweating, oxygen saturation, electrocardiogram signal and / Or biological signals selected from the group consisting of any other such useful and suitable parameters of the patient's health, symptoms or comfort may also be monitored. In one embodiment, there are multiple feedback sensors (110, 310, 516) and their output signals are for software to control the cooling element (107, 307) and the heating element (108, 308, 515). It is received by the processor (111, 311, 522) of the system controller (109, 309, 510) and / or the system controller (109, 309, 510) set in. The thermal energy system (105, 305, 505) is structured to communicate the parameters detected by the feedback sensors (110, 310, 516) with the system controller (109, 309, 510). In one embodiment, the system controller (109, 309, 510) receives the biological signal of interest from at least one feedback sensor (110, 310, 516). In one embodiment, the thermal energy system (105, 305, 505) selects one or more parameters of the software or firmware of the processor (111, 311, 522) of the system controller (109, 309, 510). It can be set by the clinician or user after implantation or placement outside the patient. In another embodiment, the parameters can be preset. In one embodiment, the user can control communication with the system controller (109, 309, 510), where the user has a degree of pain, a degree of motor function, sensory sensitivity, including touching pain, sharpness. Input factors can be selected from the group consisting of temperature and stress level. The user may also control the system by "turning on" or "turning off" the power or changing the behavior at any level.

[0075] In one embodiment, the thermal energy system (105, 305, 505) may provide information to support an acceptable arrangement of the thermal energy system (105, 305, 505). In one embodiment, the thermal energy system (105, 305, 505) is acceptable for the thermal energy system (105, 305, 505) after partial or complete blockage of the nerve using a heating step followed by a cooling step. It can be set to support various placements. In this embodiment, the thermal energy system (105, 305, 505) is a body temperature, blood pressure, heartbeat, time, sweating, oxygen saturation, electrocardiographic signal, temperature and chemical levels on or near the nerve and / or the patient's. An acceptable arrangement of thermal energy systems (105, 305, 505) based on the effect on the patient selected from the group containing any other such useful and suitable parameters of health, symptoms or comfort. Can be decided. In one embodiment, the feedback loop is applied to the thermal energy system (105, 305, 505) based on the temperature detected by the feedback sensors (110, 310, 516), including, but not limited to, the temperature sensor. It can be used to control the power delivered.

The system controller (109, 309, 510), including the processor (111, 311, 522), is a heating element of at least one heating element (108, 308, 515), of at least one cooling element (107, 307). It may be physically or wirelessly connected to control electronics (513) to control cooling and monitor nerve temperature. The system controller (109, 309, 510) can be implanted in or outside the other components of the thermal energy system (105, 305, 505). Wireless power transfer can be used to power at least one heating element (108, 308, 515), where wireless power transfer can include electromagnetic induction or microwave energy transfer.

[0077] In one embodiment, the thermal energy system (105, 305, 505) can be powered by a power source, where the power source is an internal primary battery, an internal (rechargeable) secondary battery, and electromagnetic induction. It is selected from the group consisting of power transmission, radio power transmission including microwave radio transmission, invisible laser power transmission, AC current, and kinetic energy harvesting system.

[0078] In one embodiment, the resistance heating implants (506) of the thermal energy system (105, 305, 505) can be implanted on or near the nerve to reversibly block the nerve. In a preferred embodiment, as shown as an example in FIG. 4, the resistance-heated implants (506) of the thermal energy system (105, 305, 505) are on the nerve for heating in order to reversibly block the nerve. It can be planted in or near it. The thermal energy system (105, 305, 505) is a wearable device (507) including an external chiller pump (507), a system controller (109, 309, 510), an external cooling delivery device (509), and an inductive power supply device (511). 508) and may be further included. Induction heating implants (506) optionally include echogenic guides (514), control electronics (513), at least one heating element (108, 308, 515) and at least one feedback sensor (110, 310). 516) may be included. The components of the thermal energy system (105, 305, 505) are described in detail below.

Resistance-heated implants (506) are used for about minutes to block one or more nerves or for about hours or days to treat a chronic condition or condition during a medical procedure. It can be planted for many years. In one embodiment, the resistance heating implant (506) can be a thin, linear, and totally flexible implant as shown by the example in FIG. 5A. The resistance heating implant (506) may include a rigid portion (525) and a flexible portion (526). The rigid portion (525) comprises at least one positive thermal coefficient resistance element (519), main induction element (520), at least one power control MOSFET (518), microcontroller (517) as required for operation. And control electronics (513), including supportive passive electronics (521). The flexible portion (526) may accommodate at least one heating element (108, 308, 515) and at least one feedback sensor (110, 310, 516), such as one for sensing temperature. The at least one heating element (108, 308, 515) and the at least one feedback sensor (110, 310, 516) can be components of at least one printed circuit board (PCB) (524). In one embodiment, the flexible portion (526) may include a flexible circuit that includes at least one PCB (524).

[0080] In one embodiment, at least a section of at least one component of the thermal energy system (105, 305, 505) or thermal energy system (105, 305, 505) is composed of biocompatible material or Alternatively, at least one segment of the device comprises a biocompatible coating. The biocompatible coating is a gel, airgel, hydrogel, microparticles, dermal filler 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. obtain. The biocompatible coating may be present on the induction heating implant (506) prior to implantation or may be coated on at least a portion of the induction heating implant (506) following implantation. The biocompatible coating can be biodegradable and can decompose over a finite period of time. The degradation may not occur in vivo or may only degrade slowly in vivo over a long period of time, such as months or years.

[0081] In one embodiment, the thermal energy system (105, 305, 505) is a feedback sensor (110,) to monitor a biological signal selected from the group consisting of temperature and chemical levels on or near the nerve. 310, 516) can be included. In one embodiment, the thermal energy system (105, 305, 505) is a body temperature, blood pressure, heart rate, time, sweating, oxygen saturation, electrocardiographic signal or any other such of the patient's health, symptoms or comfort. It may include feedback sensors (110, 310, 516) for monitoring biological signals selected from the group consisting of useful and suitable parameters. The thermal energy system (105, 305, 505) may communicate the parameters detected by the feedback sensors (110, 310, 516) with the system controller (109, 309, 510). In one embodiment, the user can control communication with the system controller (109, 309, 510), where the user has a degree of pain, a degree of motor function, sensory sensitivity, including touching pain, sharpness. Input factors can be selected from the group consisting of temperature and stress level. The user may also control the system by "turning on" or "turning off" the power or changing the behavior at any level.

[0082] In one embodiment, the thermal energy system (105, 305, 505) may provide information to support an acceptable deployment of the thermal energy system (105, 305, 505). In a preferred embodiment, the thermal energy system (105, 305, 505) is acceptable for the thermal energy system (105, 305, 505) after partial or complete nerve blockade using a heating step followed by a cooling step. It can provide information to support proper placement. In this embodiment, the thermal energy system (105, 305, 505) is a sensory, organ function, degree of pain, degree of motor function, temperature, sharpness, blood pressure, time, flow rate, heartbeat, sweating, stress level or patient. An acceptable arrangement of thermal energy systems (105, 305, 505) based on the effect on the patient selected from the group containing any other such useful and suitable parameters of health, symptoms or comfort. Can be determined. In one embodiment, the arrangement of the thermal energy system (105, 305, 505) is user input from the group consisting of degree of pain, degree of motor function, sensory sensitivity including touching pain, sharpness, temperature and stress level. It can be further guided by factors. In one embodiment, the feedback loop is used to control the power delivered to the thermal energy system (105, 305, 505) based on the temperature detected by the feedback sensors (110, 310, 516). obtain.

[0083] In one embodiment, the thermal energy system (105, 305, 505) is a system controller (109, 309, 510), which includes a processor (111, 311, 522) that communicates with a resistance heating implant (506). Includes external cooling delivery equipment (509), inductive power supply (511) and external chiller pump (507). A description of the communication of the system controllers (109, 309, 510) will be described in detail below.

[0084] In one embodiment, the resistance heating implants (506) of the thermal energy system (105, 305, 505) provide heating to the nerves as directed by the system controller (109, 309, 510), and Power is supplied by a radiated electromagnetic field from the inductive power supply device (511). In a preferred embodiment, the microcontroller (517) within the resistance heating implant (506) communicates with the system controller (109, 309, 510) and receives a secure enable signal from the system controller (109, 309, 510). After reception, the temperature setting point and duration of heating are determined as needed to reversibly block the nerves, the power flow to at least one heating element (108, 308, 515) is controlled, and It indicates other functions of the resistance heating type implant (506). The microcontroller (517) may wirelessly communicate with the system controller (109, 309, 510) or may be physically connected to the system controller (109, 309, 510). Wireless communication may be by Bluetooth connection or any other suitable wireless communication means. Since the outpatient radio signal may not be recognized by the microcontroller (517), the unexpected heating event of the resistance heating implant (506) can be avoided.

[0085] In one embodiment, the inductive power supply (511) feeds the resistance heated implant (506) as directed by the system controller (109, 309, 510). The induction power supply device (511) may be placed so that the induction heating implant (506) can be inductively fed to the resistance heating implant (506). The microcontroller (517) of the induction heating implant (506) uses at least one power control MOSFET (518) or other solid switch from the induction power supply device (511) to at least one heating element (108, 308). The power transmitted to 515) can be limited. The at least one power control MOSFET (518) may have a modified pulse width. The at least one power control MOSFET (518) can be used to gradually increase the power so that the at least one heating element (108, 308, 515) reaches its temperature setting point. In a preferred embodiment, the temperature setting point of at least one heating element (108, 308, 515) is about 45 ° C. The microcontroller (517) can be used to maintain low power levels and direct continuous monitoring of the temperature at which the nerves are cooling. The microcontroller (517) may communicate continuously with the system controller (109, 309, 510) to provide a continuous feedback loop. The positive thermal coefficient resistor element (519) can be used as a fail-safe system to analogally limit power to the induction heating implant (506) in the event of a malfunction. The built-in fuse of at least one heating element (108, 308, 515) protects the at least one heating element (108, 308, 515) against overcurrent events and at least one in such an overcurrent event. One heating element (108, 308, 515) can be blocked.

[0086] In one embodiment, at least one heating element (108, 308, 515) is an electrical resistance heating element, an induction heating element, a perche heater, a microwave heating element, a high frequency heating element, an infrared emitter or a nerve thermal control. It can be any other suitable heating means capable of providing the required heating temperature and duration in the modest heating step in. In one embodiment, the feedback sensors (110, 310, 516) are temperature sensors, such as thermocouples, thermistors or after thermal conditioning to block or partially block thermocouples, during and after thermal conditioning. Any other suitable device or material capable of monitoring changes in nerve temperature. Feedback sensors (110, 310, 516) are located in or near the periphery of at least one heating element (108, 308, 515), or elsewhere in the body or body, or elsewhere in the device. Can be done. In one embodiment, an optional at least one echogenic guide (514) or other such suitable guide material or device is placed within the resistance heating implant (506) and said resistance heating implant. Can support the placement of (506).

[0087] In one embodiment, nerve cooling by a thermal energy system (105, 305, 505) can be applied externally. In one embodiment, nerve cooling is delivered by an external cooling delivery device (509) connected to an external chiller pump (507). An external cooling delivery device (509), an inductive power supply (511) and a system controller (109, 309, 510) can be positioned at a target location, wherein the target location is described in FIG. 4 and FIG. 5B. As shown in the example, it is in contact with the implanted resistance-heated implant (506) and the skin covering its target nerve. In a preferred embodiment, the external cooling delivery device (509), the inductive power supply device (511) and the system controller (109, 309, 510) are housed in the wearable device (508) and thus the wearable device (508). Can be positioned at the target site, where the target site is in contact with the implanted resistance-heated implant (506) and the skin covering its target nerve. The wearable device (508) houses the patch, headband, strap, band or the external cooling delivery device (509), inductive power supply device (511) and system controller (109, 309, 510) at the target location. And it can be any such means of providing thermal contact between the skin and the wearable device (508). In one embodiment, the wearable device (508) is constructed of a soft, compatible elastic material (eg, Shore Scale 25A) with a strap or other suitable means, which may be adapted to the patient's target location. In one embodiment, a thin and compatible thermally conductive elastomer, such as COOLPOLY® Thermally Conductive Plastic (Celanese, Ltd.), allows the wearable device (508) to make thermal contact with the wearable device (508). ) Can be coated on the side of the patient in contact with the skin. In one embodiment, the thermally conductive gel can be used to enhance thermal contact with the wearable device (508). In a preferred embodiment, the wearable device (508) can be a headband positioned to treat a pain-related condition associated with the occipital nerve.

[0088] The external cooling delivery device (509) of the thermal energy system (105, 305, 505) may use the cold fluid provided by the external chiller pump (507) to perform nerve cooling. In one embodiment, the external cooling delivery device (509) and the external chiller pump (507) are housed in a wearable device (508). In a preferred embodiment, the external cooling delivery device (509) is housed in a wearable device (508) and is connected to an external chiller pump (507) at different locations. Since the external cooling delivery device (509) and the external chiller pump (507) can be connected by a cooling fluid pipeline that can be insulated, the cold fluid is sent from the external chiller pump (507) to the external cooling delivery device (509) at the target location. And the regenerated fluid can be returned from the external cooling delivery device (509) to the external chiller pump (507) for cooling. In one embodiment, the external chiller pump (507) may include a Pelche cooling system so that the regenerated fluid can be cooled to be a cold fluid for reuse. The regenerated fluid can be collected in the regenerated fluid tank (512) of the external chiller pump (507) and the temperature of the fluid in the regenerated fluid tank (512) is rapid as instructed by the system controller (109, 309, 510). Ascends or decreases. In one embodiment, the system controller (109, 309, 510) may instruct the external chiller pump (507) to control the cold fluid temperature and flow rate in the cooling fluid pipeline. The external chiller pump may include at least one feedback sensor (110, 310, 516) for monitoring the temperature of the cold fluid, the regenerated fluid and the temperature inside the regenerated fluid tank (512). The at least one feedback sensor (110, 310, 516) is to provide temperature readings continuously or as directed by the system controller (109, 309, 510) to the system controller (109, 309, 510). ) Can communicate with.

The regenerated fluid and the cold fluid can be of the same composition and can be located in the cooling fluid pipeline of the thermal energy system (105, 305, 505). The only significant difference between regenerated and cold fluids can be their respective temperatures, and the regenerated and cold fluids can be converted to each other by alternating their temperatures. The composition of both the regenerated fluid and the cold fluid can be saline or any other suitable fluid, which can be cooled to the temperature required to cool the nerve without the fluid freezing. In a preferred embodiment, the cold fluid can be cooled to a temperature of about 0 ° C. or just below about 0 ° C., and the nerve can be cooled to a temperature as indicated by the system controller (109, 309, 510). ..

[0090] FIGS. 6A-6B demonstrate the effect of distance on tissue heating and cooling. In FIG. 6A, the cooling steps required to cool the nerve to about 15 ° C. are demonstrated using simulation. In the simulation, the cold fluid can bring a temperature of 0 ° C to the target area of the patient's skin for about 10 minutes, producing a temperature of 15 ° C for nerves within 8 mm of the surface of the skin, while the cold fluid can bring the temperature to 0 ° C. It was determined that the temperature of 15 ° C. could be produced in the skin of the patient at the target site for about 20 to about 30 minutes and the nerves within 20 mm of the surface of the skin. Beyond a depth of 20 mm from the surface of the skin, the temperature required for the cold fluid may be unpleasant or unacceptable to the patient, and may need to generate extraneous energy, thus causing nerves from the outside. Cooling can be difficult to achieve. Once a nerve cooling temperature of 15 ° C is achieved, it may be possible to maintain a cooling temperature of 15 ° C on the nerve with a cold fluid having a temperature ranging from about 8 ° C to about 10 ° C on the patient's skin surface. It has been determined. In FIG. 6B, the implanted resistance-heated implant (506) is heated to 45 ° C. at a depth of 20 mm within the tissue, and the temperature of the tissue is monitored at various distances from the resistance-heated implant (506). ing. The heating from the resistance heating implant (506) remains approximately equal to the target temperature of 45 ° C., but the temperature of the tissue decreases by several degrees with distance.

Insertion of the resistance heated implant (506) can be performed by any suitable insertion or surgical means known in the art. In one embodiment, insertion of the resistance heated implant (506) can be performed using an insertion device (535) as shown in FIG. The insertion device (535) may include an insertion sheath (538), a sheath control arm (537) and a plunger (536) and may be composed of any material that can be sterilized for insertion into the patient's body. The insertion sheath (538) may surround, otherwise surround or incorporate the resistance-heated implant (506) to guide the resistance-heated implant (506) to a target site for insertion. The sheath control arm (537) is pulled by the clinician while the clinician holds the plunger (536) to allow the insertion sheath (538) to be retracted and the resistance heated implant (506). Is exposed and the insertion device (535) can be removed from the target site. The implanted resistance heating implant (506) can remain at its inserted target site.

[0092] In one embodiment, the thermal energy system (105, 305, 505) comprises a thermal energy probe (405). The thermal energy probe (405) may be configured to include a horseshoe, a C-shape, a U-shape, a bowl and a semi-circular shape, as shown as an example in FIG. The thermal energy probe (405) can be implanted at or near the nerve to provide heating and / or cooling, allowing the nerve to undergo reversible blockade. In one embodiment, the thermal energy probe (405) is U-shaped and extends around the nerve. The material of the thermal energy probe (405) can be composed of any material that is thermally conductive and biocompatible when implanted at or near the nerve. In one embodiment, the thermal energy probe (405) is composed of silver. The thermal energy probe (405) can be produced by three-dimensional printing, injection molding, commercial casting or any other suitable production technique.

[0093] The thermal energy probe (405) can be sized to correspond to the diameter of the nerve, so that the thermal energy probe (405) extends around the nerve as desired for reversible blockade of the nerve. Or allow it to extend a certain distance along the nerve. In one embodiment, the U-shaped thermal energy probe (405) surrounds the nerve at least on three of the four sides from a planar axial view as shown in FIG. Allows uniform temperature distribution to be maintained throughout a section. Therefore, the cross-sectional parameters of the thermal energy probe (405) can be determined by the diameter of the nerve, which can be the target of reversible blockade. The thermal energy probe (405) can be of millimeter scale, including, for example, a 4 mm × 3 mm × 5 mm thermal energy probe (405) for a nerve having a diameter of 2 mm and an axial cross section of 2 mm.

[0094] In one embodiment, the size of the thermal energy probe (405) can be calculated from the dimensions of the target nerve according to equations (1)-(4) with reference to the dimensions of FIGS. 10A-10B.
X1 = D + 1.5mm (1)
X2 = X1 + 2mm (2)
Y = D + 2mm (3)
Z = Zn + 1.5mm (4)

[0095] 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 formula (2), X1 is the dimension of the U-shaped thermal energy probe (405) as shown in FIG. 10A. In formula (3), Y is the dimension of the U-shaped thermal energy probe (405) as shown in FIG. 10A. In formula (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.

[0096] In one embodiment, the thermal energy probe may further include at least one fluid channel (406), the heating or cooling fluid enters the thermal energy probe (405), and the thermal energy is transferred to the thermal energy probe (405). ) To heat or cool the nerve. The at least one fluid channel (406) can have a diameter of about 0.3 mm or any diameter suitable for fitting into the tube (407). The at least one fluid channel (406) can have a length of about 1.5 mm or any other suitable length to ensure that the tube (407) is held in place and has thermal energy. The size of the probe (405) is minimized for implantation. At least one fluid channel (406) can provide inlets and outlets for the heating or cooling fluid and provides the heating or cooling fluid behind the thermal energy probe (405) or to the thermal energy probe (405). It can be located in any suitable location with respect to what to do. The heating or cooling fluid can be water, saline or any other suitable fluid, and the fluid is heated to the temperature required to heat or cool the nerve without the fluid evaporating or freezing. Can be or can be chilled. The cooling or heating fluid can exit from the thermal energy probe (405) through at least one fluid channel (406) that can serve as an outlet. In one embodiment, the cooling or heating fluid can be carried through at least one fluid channel (406) using a tube (407), which is flexible, insulated, and at least. Fits to fit the dimensions of one fluid channel (406).

[0097] In one embodiment, the thermal energy probe (405) further comprises a coating of conductive gel (408) on the surface closest to the nerve, as shown in FIGS. 9-11. The conductive gel (408) can be used to cushion the nerve impact within the thermal energy probe (405) and can facilitate the transfer of thermal energy from the thermal energy probe (405) to the nerve. Conductive gel (408) may further function to maintain low levels of temperature dispersion throughout at least one section of the nerve. A conductive gel (408) with higher thermal conductivity can result in more efficient thermal energy transfer from the thermal energy probe (405). Conductive gel (408) can be biocompatible for implantation in or near nerves. Other thermally conductive gels or materials are considered for use in the present invention.

[0098] In one embodiment, the thermal energy probe (405) may include an adiabatic lining (409) on at least one surface of the thermal energy probe (405) that does not interact with nerves. The thermal lining (409) may contain solids that meet the characteristics of the thermal energy probe (405) and insulate with low thermal conductivity. In one embodiment, the adiabatic lining (409) is made of polyurethane and the thermal conductivity of the adiabatic lining (409) is about 0.027 W / mK. The adiabatic lining (409) can be located on the back surface of the thermal energy probe (405) and can adapt to features such as at least one fluid channel (406). The adiabatic lining (409) can prevent the loss of thermal energy from the energy probe (405). A thermal energy probe (405) with an adiabatic lining (409) is shown in FIG.

[0099] In one embodiment, the thermal energy probe (405) is implanted at or near the nerve for reversible blockade. The placement of the thermal energy probe (405) is guided by ultrasound and can be inserted through the incision using an applicator or other suitable device for placing the thermal energy probe (405). .. The thermal energy probe (405) can be positioned to cushion the nerve impact by a conductive gel (408) that coats the surface of the thermal energy probe (405). If a U-shaped thermal energy probe (405) is used, the conductive gel (408) can be coated on the inside of the U-shaped feature. In one embodiment, the insulation (410) can be injected or placed around the thermal energy probe (405) during insertion. The insulation (410) may help limit thermal energy transfer to the desired location and retain the thermal energy probe (405) at or near the nerve at the desired location. The insulation (410) can be injected substantially spherically around the nerve and thermal energy probe (405) and can be accompanied by one or more injections for application at the desired location. In one embodiment, the insulation (410) can be injected into a sphere 10 mm in diameter. The insulation (410) can be insulating and biocompatible, and can be a liquid, gel or foam. In a preferred embodiment, the insulation (410) is a polyurethane foam having a thermal conductivity of about 0.027 W / mK. Insulation material (410) with low thermal conductivity is desirable. The insulation (410) is low enough to allow injection into the site, but should be high enough to prevent it from leaving the target area after some time of installation. .. The ideal insulation (410) can be a self-curing material, such as CryoLife's BioFoam Surgical Matrix, that is ready to be injected as a liquid and then chemically react to solidify and maintain its shape and location.

[00100] Insulation gels, self-curing polymers, foams, plastics or other biocompatible polymers or composites are injected or inserted into the body and the gel or material affects the device and the surroundings of the target nerve. By reducing the thermal conductivity and thermal energy transfer rate in regions outside the desired region to receive, heating and / or cooling of the thermal energy system (105, 305, 505) can be directed or included. .. The adiabatic gel or material can also prevent the spread of thermal energy over areas that would otherwise be spread, which is preferably the use of more targeted thermal conditioning or thermal conditioning. It may allow the use of thermal regulation in and near non-existent areas. This limitation of thermal energy is not the cause of pain, but causes discomfort without affecting the nerves that control movement or sensation, such as clearly targeted nerves in the joints. Can be useful in. Insulation gels, foams or other carrier materials are generally made by combining a base polymer with an adiabatic filler. Base polymers may include hydrogels and silicones, including gels that can be injected at room temperature and in their final form that can be cured by body temperature at that location. Fillers generally have a thermal conductivity. 1-. Polyurethane foams, polystyrenes, glass fibers and airgels such as polystyrene, Cabot corp aerogels and General Plastics corp polyurethane foams may be included as used to provide insulating polymers in the range of 01 W / mK. Other insulating gels or materials are considered for use in the present invention.

[00101] The thermal energy probe (405) may include a positioning hook that can be deployed after insertion, thus ensuring that the thermal energy probe (405) is locked to the nerve or a desired location near it.

[00102] In one embodiment, the thermal energy probe (405) may be connected to components for controlling fluid flow and temperature. The components can be implanted or external to the patient. Components may include pumps, heat exchangers, thermoelectric coolers, system controllers (109, 309, 510), power supplies and tubes (407). The pump transports the heating or cooling fluid through the tube (407) into the thermal energy probe (405) as shown in FIGS. 12A-B and as directed by the system controllers (109, 309, 510). Can be used for. The power source can be a battery or any other power source suitable for powering the components of the thermal energy system (105, 305, 505).

[00103] 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 from about 42C to about 54C. In one embodiment, the cooling fluid is from about 2C to about 15C. In a preferred embodiment, the cooling fluid is about 15C and the heating fluid is about 50C during heating and cooling and ± 2C for the surrounding tissue. The system controller (109, 309, 510) may instruct the heat exchanger and / or thermoelectric cooler so that the temperature can be maintained in the nerve. The fluid can be regenerated 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 can range from about 0.0004 L / min to about 0.0001 L / min, depending on the temperature of the heating or cooling fluid. The pump can provide a pressure of about 5 mbar to about 400 mbar to achieve these flow rates, depending on the diameter of the tube (407).

[00104] The device or system used for heat regulation for reversible blockade is based on the type and duration of pain and the depth of nerves from the skin, as shown as an example in FIGS. 13A-C. Can be adjusted. In one embodiment, nerve-related pain can be chronic or acute, where chronic pain can be long-lasting and can occur for days, weeks, months or years of duration, and. Acute pain can be recent and / or sudden onset and can occur for a short duration of hours, days, weeks or months. In one embodiment, chronic pain can occur for a duration of at least about 3 months. In one embodiment, acute pain can occur for a duration of about 2 weeks or less. Chronic pain can include a period of remission or a period of recurrence and can 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 can be persistent or sporadic, persistent pain occurs continuously at one or more levels of severity, and sporadic pain is regular or irregular pain attacks. It can occur intermittently with one or more levels of severity. The device determination in FIGS. 13A-C is exemplary and the method of device selection and use may vary from patient to patient. The range of target nerve depths considered for the various embodiments of the invention can vary from patient to patient and are exemplified in FIGS. 13A-13C.

[00105] The choice of implantable or externally mounted heating and / or cooling elements (108, 308, 515), (107, 307) is at least partly an individual's sense of nerve depth and temperature. Based on cognitive ability and tolerance. Sufficient heating of the nerve to initiate and maintain nerve block, eg, nerve temperature reaching about 40-45 ° C., is when the depth of the nerve underneath the skin is about 4-8 mm or less. For most patients, the heating element (108, 308, 515) is generated externally, in which case the heating element (108, 308, 515) is used when the patient has a special sensitivity to warm temperatures or otherwise. It may be preferentially out of this range unless it is preferred to implant heating elements (108, 308, 515) in. Nerve blocks deeper than about 4-8 mm below the surface of the skin generally require a heating element (108, 308, 515) to be implanted, and once implanted, about 1-8 of the nerve. Need to be within millimeters. Sufficient cooling of the nerve to initiate and maintain nerve block, eg, nerve temperature in the range of about 15-30 ° C., allows cooling elements (107, 307) to be optionally implanted or When the nerve depth is less than about 20-25 mm, such as outside the nerve depth in this range, it can be generated externally through the skin by the cooling element (107, 307). When the nerve is deeper than about 20-25 mm, the cooling element (107, 307) and the heating element (108, 308, 515) generally need to be implanted for maximum potency. 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 are narrowed by inserting thermally conductive materials such as gels, elastomers or other mixtures between heating and / or cooling elements (108, 308, 515), (107, 307) and nerves. obtain.

[00106] In one embodiment, heat regulation comprises reversible blockade for the treatment of chronic persistent pain (205), as illustrated as an example in FIG. 13A. In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. Nerve thermal regulation can be examined clinically to assess the effect of reversible blocking. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment, thermal regulation can be applied from a fully implanted thermal system (206). If heat regulation is unsuccessful, heat regulation may not be appropriate for treatment, and other options may be investigated (207).

[00107] In one embodiment, heat regulation comprises reversible blockade for the treatment of chronic sporadic pain (208), as illustrated as an example in FIG. 13A. In one embodiment, the nerve is located at a depth greater than about 20 mm from the patient's skin (209). In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment where the nerves are located at a depth of more than about 20 mm from the patient's skin, thermal regulation can be applied from a fully implantable thermal system (206). If heat regulation is unsuccessful, fever may not be suitable for treatment, and other options may be investigated (207). In one embodiment, the nerve is located at a depth in the range of about 6 mm to about 20 mm from the patient's skin (210). In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment where the nerve is located at a depth in the range of about 6 mm to about 20 mm from the patient's skin, thermal regulation can be performed by percutaneous cooling (220) and an implantable induction heating device (219). If heat regulation is unsuccessful or partially successful, fever may not be suitable for treatment, and other options may be investigated (207). In one embodiment, the nerve is located at a depth of less than about 6 mm from the patient's skin (211). In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment, when the nerve is located at a depth of less than about 6 mm from the patient's skin, thermal regulation can be performed by a percutaneous heating and cooling device (212). If heat regulation is unsuccessful or partially successful, heat regulation may not be appropriate for treatment, and other options may be investigated (207).

[00108] In one embodiment, heat regulation comprises reversible blockade for the treatment of acute persistent pain, as illustrated as an example in FIG. 13B (213). In one embodiment, the nerve is located at a depth greater than about 20 mm (209) from the patient's skin or (210) in the range of about 6 mm to about 20 mm from the patient's skin. In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment, the thermoregulator can be a temporary thermal probe when the nerve is located at a depth greater than about 20 mm from the patient's skin or in the range of about 6 mm to about 20 mm from the patient's skin (215). Allow the physician to assess the need for continuous heat regulation as needed. If thermal conditioning continues to be required (216), the device may continue to be used. If thermal regulation is no longer needed (217), the device can be removed (218). If heat regulation is unsuccessful, heat regulation may not be appropriate for treatment, and other options may be investigated (207). In one embodiment, the nerve is located at a depth of less than about 6 mm from the patient's skin (211). In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment where the nerves are located at a depth of less than about 6 mm from the patient's skin, thermal regulation can be performed by a percutaneous heating and cooling device (212). If heat regulation is unsuccessful or partially successful, heat regulation may not be appropriate for treatment, and other options may be investigated (207).

[00109] In one embodiment, thermal regulation comprises reversible blockade for the treatment of acute sporadic pain, as illustrated as an example in FIGS. 13B-13C (214). In one embodiment, the nerve is located at a depth greater than about 20 mm from the patient's skin (209). In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment where the nerve is located at a depth greater than about 20 mm from the patient's skin, the heat control device can be a temporary thermal probe (215), requiring the physician to continuously control the heat as needed. Be able to evaluate sex. If thermal conditioning continues to be required (216), the device may continue to be used. If thermal regulation is no longer needed (217), the device can be removed (218). If thermal regulation is unsuccessful, thermal regulation or electrical regulation may not be appropriate for treatment, and other options may be investigated (207). In one embodiment, the nerve is located at a depth in the range of about 6 mm to about 20 mm from the patient's skin (210). In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. In one embodiment, thermal regulation is examined clinically and reversible blockade is evaluated. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment where the nerve is located at a depth in the range of about 6 mm to about 20 mm from the patient's skin, thermal regulation is performed using percutaneous cooling (220) and an implantable induction heating device (219). obtain. If heat regulation is unsuccessful or partially successful, heat regulation may not be appropriate for treatment, and other options may be investigated (207). In one embodiment, the nerve is located at a depth of less than about 6 mm from the patient's skin (211). In this case, the target nerve response may first be examined clinically to determine its response to thermal regulation. In one embodiment, thermal regulation is examined clinically and selective blockade is evaluated. If the thermal control is successful, the thermal control device or system can be utilized either as an external or implantable device. In a preferred embodiment where the nerves are located at a depth of less than about 6 mm from the patient's skin, thermal regulation can be performed using a percutaneous heating and cooling device (212). If heat regulation is unsuccessful or partially successful, heat regulation may not be appropriate for treatment, and other options may be investigated (207).

[00110] If deciding to utilize a heat control device, the patient or other user may be trained or instructed regarding the use of the device. Thermal conditioning can be done using thermal blocks. Thermal blocks can include the use of various degrees of implantable equipment, from completely external percutaneous systems to fully implantable systems. For example, the thermal block may include the use of thermal energy probes, percutaneous cooling and inductively fed heating equipment, percutaneous heating and cooling equipment or fully implantable thermal systems.

[00111] The heating element and / or the cooling element is mounted on or inside the body near the nerve, and a conductive gel or elastomer is inserted around the heating element and / or the cooling element in the body. Further disclosure of methods for selecting the affected area for heat energy transfer between a thermal energy device for reversible blocking of the area surrounding the nerve in the body and the affected surrounding area, which may be near the nerve. Will be done.

[00112] In the present specification, the heating element and / or the cooling element is attached on or inside the body near the nerve, and the heat insulating property is provided around the desired affected area surrounding the heating element and / or the cooling element in the body. Inserting a gel or elastomer to concentrate the heat block between the desired affected area (consisting of heating and / or cooling elements and nerves) and other areas of the body where the effects of temperature are not desired. Further disclosed are methods of selecting affected areas for heat energy transfer between heat energy devices for reversible blockade of the area surrounding the nerves in the body, including.

[00113] A method of using sensor data such as temperature, pressure, time and / or flow rate, the equipment used and the use of sensor data, and in some cases, but not required, a mechanical interface as an input to the feedback loop. Provided, but not limited to, human input or algorithmic control to heat or cool the pump flow rate or Pelche electrodes or other temperature control equipment to change the temperature as directed by the algorithmic control. Methods, devices and uses that include algorithms that control the output of the systems / devices described herein, including temperature. The present invention also includes other sources of data from wearable devices, such as heart rate, degree of sweating, cardiac function / cardiac performance, blood pressure, stress level or GPS, as non-comprehensive examples. Other sensors may be added to the device or included in the system inputs to optimally control nerve conduction. The present invention also includes algorithmic control over other outputs not specifically listed herein that affect the operation or performance of the device in any way.

Claims (21)

A method of determining the configuration of a thermal energy device for a patient to reversibly block nerves within the patient's body.
a. Determining the depth of the nerve in the patient's body,
b. Determining whether the heating and / or cooling elements of the thermal energy device should be implanted within the body or externally mounted on the body according to a depth in the following range:
i. For a depth range from zero to about 4-7 mm, each of the heating and cooling elements can optionally be externally mounted or implanted.
ii. For a depth range of about 4-7 mm to about 20-25 mm, the heating element shall be implanted and the cooling element may optionally be externally mounted or implanted. Get or iii. A method comprising determining that the heating element and the cooling element shall be implanted for a depth range of about 20-25 mm or greater. A method of reversibly blocking pain signals transmitted by nerves in the body for reversible blocking.
a. Wearing a heating element and / or a cooling element on or in the body near the nerve
b. Inserting a conductive polymer into the body between the heating and / or cooling element and the nerve
c. A method comprising activating the heating element and / or the cooling element. A thermal energy system for the reversible blockade of nerves in the subject's body.
With at least one heating element configured to be implanted near the nerve,
With at least one cooling element configured to be externally located on the subject's skin,
With at least one feedback sensor configured to detect temperature on or near at least one location,
With the temperature controller
A system controller, wherein the system controller and the temperature controller are configured to be connected to a power source, communicate with the feedback sensor, and control the heating element and the cooling element. A thermal energy system equipped with. The system controller and the temperature controller are configured to control the heating element and the cooling element based on the detected temperature received from the at least one temperature sensor and / or based on user input. Item 3. The thermal energy system according to Item 3. The thermal energy system of claim 3, wherein the cooling element cools a fluid carried through the cooling element to an interface for the skin in one or more coolant channels. The thermal energy system according to claim 3, wherein the heating element is selected from the group consisting of an electric resistance heating element, an induction heating element, a perche heater, a microwave heating element, a high frequency heating element, and an infrared emitter. The heating element includes a flexible portion including the electric resistance heating element fed by an induction coil that receives a radiated electromagnetic field, and the flexible portion is connected to an internal control mechanism including the temperature controller. The thermal energy system according to claim 6, wherein the temperature controller optionally wirelessly communicates with the system controller. The thermal energy system according to claim 3, wherein the heating element is heated by a heating fluid received through a percutaneous tube from a heating fluid tank that communicates with a heating fluid pump controlled by the system controller. A complete external thermal energy system for the reversible blockade of nerves in a subject,
With at least one heating element configured to be externally located on the subject's skin,
With at least one cooling element configured to be externally located on the subject's skin.
With at least one feedback sensor capable of detecting temperature near the nerve or at least one point in the system.
With the temperature controller
A power supply to the at least one feedback sensor and a system controller connected to the temperature controller, wherein the system controller and the temperature controller are enabled by the heating phase enabled by the heating element and the cooling element. A fully external thermal energy system comprising a system controller configured to control the heating element and the cooling element so as to make a temperature transition to and from the cooling phase. The fully external thermal energy system of claim 9, wherein the transition between the heating phase and the cooling phase occurs in less than one minute. The external thermal energy system according to claim 9, wherein the cooling phase is in the range of 0 ° C to 15 ° C. The fully external thermal energy system of claim 9, wherein the cooling phase is in the range of 15 ° C to 35 ° C. The fully external thermal energy system of claim 9, wherein the at least one heating element and the at least one cooling element are housed in a headband and are positioned at the subject's head near the occipital nerve. A method of reversibly blocking nerves in a subject's body by all external means by the system according to any one of claims 9-13. A thermal energy system for the reversible blockade of nerves in the subject's body.
With at least one heating element configured to be implanted near the nerve,
With at least one cooling element configured to be implanted near the nerve,
With at least one feedback sensor configured to detect the detected temperature near at least one location,
With an external system controller
With the temperature controller
The external system controller and the power supply connected to the temperature controller are provided.
The feedback sensor communicates the detected temperature to the external system controller and the temperature controller, and the external system controller and the temperature controller are configured to control the heating element and the cooling element. Energy system. The external system controller and the temperature controller are configured to control the heating element and the cooling element based on the detected temperature received from the at least one temperature sensor and / or based on user input. The thermal energy system according to claim 15. The thermal energy system according to claim 15, wherein the heating element and / or the cooling element is connected to the external system controller by a percutaneous wire. The heating element is heated by a heating fluid received through a percutaneous tube from at least one fluid tank that communicates with the at least one fluid pump controlled by the external system controller, and / or the cooling element is said to be said. 15. The thermal energy system of claim 15, wherein the thermal energy system is cooled by a cooling fluid received through a percutaneous tube from at least one fluid tank that communicates with at least one fluid pump controlled by an external system controller. The thermal energy system according to claim 15, wherein the system controller receives and processes a biological signal of the object from the at least one feedback sensor. A fully implantable thermal energy system for the reversible blockade of nerves within the subject's body.
With at least one heating element configured to be implanted near the nerve,
With at least one cooling element configured to be implanted near the nerve,
With at least one feedback sensor capable of detecting temperature near at least one location,
A fully implantable thermal energy system comprising a temperature controller and a system controller connected to a power source and configured to control the heating element and the cooling element. The system controller and the temperature controller are configured to control the heating element and the cooling element based on the detected temperature received from the at least one temperature sensor and / or based on user input. Item 20. The thermal energy system.

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