Patent Publication Number: US-2016242956-A1

Title: Pre and post anesthetic cooling device and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application No. 62/120,629, filed on Feb. 25, 2015. 
    
    
     FIELD OF THE INVENTION 
     The present invention pertains to a device and a method for temperature controlled cooling of the skin/epidermis or mucous membrane/mucosa. In particular, the present invention is directed to devices and techniques to alleviate pain associated with medical treatments, such as injections and skin ablation applied to the human body. 
     BACKGROUND OF THE INVENTION 
     Nerve conduction block is an important technique for use in the medical and dental fields. Currently, nerve conduction block is achieved by application of chemical compounds/formulations such as topical and local anesthesia, or via thermal application such as ice. 
     Topical anesthetics reversibly block nerve conduction near their site of administration, thereby producing temporary loss of sensation in a limited area. Nerve impulse conduction is blocked by decreasing nerve cell membrane permeability to sodium ions, possibly by competing with calcium-binding sites that control sodium permeability. This change in permeability results in decreased depolarization and an increased excitability threshold that, ultimately, prevents the nerve action potential from forming. 
     Disadvantages to topical anesthetic are variability in systemic absorption, toxicity, poor absorption through intact skin, allergic reactions and adverse effects. Adverse effects are usually caused by high plasma concentrations of topical anesthetics that typically result from excessive exposure caused by application to abraded or torn skin. Possible adverse effects include the following: burning or stinging that may occur local to the administration site; and oral viscous lidocaine that may cause systemic toxicity, particularly with repeated use in infants or children. In the Central Nervous System (CNS), high plasma concentration initially produces CNS stimulation (including seizures), followed by CNS depression (including respiratory arrest). The CNS stimulatory effect may be absent in some patients, particularly when amides (e.g., tetracaine) are administered. Solutions that contain epinephrine may add to the CNS stimulatory effect. In Cardiovascular applications, high plasma levels typically depress the heart and may result in bradycardia, arrhythmias, hypotension, cardiovascular collapse, and cardiac arrest. Local anesthetics that contain epinephrine may cause hypertension, tachycardia, and angina, while gag-reflex suppression may occur with oral administration. 
     Other body systems can also experience adverse effects such as transient burning sensation, skin discoloration, swelling, neuritis, tissue necrosis and sloughing, and Methemoglobinemia (with prilocaine). 
     The United States Food and Drug Administration (FDA) has issued an advisory regarding risk of serious adverse effects with the use of topical anesthetics for cosmetic procedures. Life-threatening adverse effects have occurred following topical anesthetic application over large surface areas of the body. Two women experienced seizures, coma, and death following applying topical anesthetics to their legs with an occlusive dressing before laser hair removal. 
     Studies indicate that lowering the body temperature at an injured site can reduce swelling and pain while promoting healing. A common technique to provide relief to an injured site or analgesia before injection is to apply ice, usually in an ice pack. Although ice has the advantage of being inexpensive and readily available, it is not healthy to apply ice to the skin for prolonged periods of time. Another disadvantage of using ice is that it can cause cellular damage if it is applied for more than a few minutes in one area due to temperatures below 0° C. As a result, ice only cools the upper surface of the skin and deep penetration of the cooling process does not take place. 
     Achieving pain free injections can be difficult for dentists, especially through taut tissue such as in the hard palate of the mouth. 
     Fear-related behaviors have long been recognized as the most difficult aspect of patient management and can be a barrier to good care. Anxiety is one of the major issues in the dental treatment of children, and the injection is the most anxiety-provoking procedure for both children and adults. 
     Fears of dental injections remain a clinical problem often requiring cognitive behavioral psychology counseling and sedation in order to carry out needed dental treatment. High levels of dental anxiety and fear have been reported in many industrialized Western societies. There is considerable evidence that dental fear is related to poorer oral health, reduced dental attendance and increased treatment stress for the attending dentist. Indeed, fear of needles and the treatment of injection fear has been an important focus. Needle fear, in particular, is a major issue given that the delivery of local anesthesia via injection is the central plank of pain relief techniques in dentistry and dentists as well as patients often avoiding difficult injections as a consequence, resulting in poor pain control. 
     Thus, there is a need for methods to avoid the invasive, and often painful, nature of the injection, and in particular, to find more comfortable and pleasant means for anesthesia before dental procedures. 
     Application of a cooling device to control pain associated with procedures such as laceration repair may avoid the need for infiltrative local anesthesia injections and associated pain from the injections. Cooling also avoids the risk of wound margin distortion that exists with infiltrative injection administration. 
     U.S. Pat. No. 7,981,080 discloses a cooling device that is a bulky hypodermic injection arrangement with an opening that does not allow for direct contact to the skin with the cooling plate. However, the bulkiness does not allow for visualization of the injection site, thereby making it difficult for the clinician to use. 
     U.S. Pat. No. 8,758,419 (the &#39;419 patent) discloses a contact cooler that uses recirculating temperature controlled fluid. The &#39;419 patent discloses a handle attached by a hose to a large control unit where the thermoelectric plates and fluid are housed, however, this unit is very bulky due to the control unit size. In addition, the head of the unit is too large to be used intra-orally and has a reduced cooling capacity due to the fluid having to travel a distance from the cooling plates in the unit to the source it is cooling. 
     Thus, there is a need for a device and method to provide pain relief that does not have the aforementioned shortcomings. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to a novel thermoelectric device and method for transient nerve cooling block of the peripheral nerves system. The thermoelectric cooling device of the present invention allows for temperature controlled cooling of the skin/epidermis or mucous membrane/mucosa, in order to alleviate pain associated with medical treatment such as injections and skin ablation applied to the human body. The cooling device comprises a body that efficiently conducts heat away from the thermoelectric section of the device. The cooling device body comprises a proximal gripping end (i.e., handle) connected to a distal head section by a neck section. 
     In one embodiment, the user (i.e., a clinician) first numbs the target tissue by placing the cooling surface of the thermoelectric assembly located in the distal head section of the thermoelectric cooling device against the tissue. The cool side covered with a hygienic barrier sleeve contacts the tissue for 35 seconds or less until the tissue reaches 6° C. or less. Then, the clinician removes the intra-oral or extra-oral thermoelectric device and inserts the hypodermic needle into the target tissue, thereby allowing for a pain-free experience for the patient. 
     In another embodiment, the user (i.e., a clinician) first numbs the target tissue by placing the cooling surface of the thermoelectric assembly located in the handle section of the thermoelectric cooling device against the tissue. The cool side covered with a hygienic barrier sleeve contacts the tissue for 35 seconds or less until the tissue reaches 6° C. or less. Then, the clinician removes the intra-oral or extra-oral thermoelectric device and inserts the hypodermic needle into the target tissue allowing for a pain-free experience for the patient. 
     In an embodiment, the present invention is directed to a thermoelectric anesthetic cooling device comprising a device body comprising a handle; a distal head end, wherein the distal head end comprising a head section and a neck section; a proximal end; and a plurality of thermally conductive layers for dissipating heat from the cooling device. The cooling device of the present invention further comprises a thermoelectric assembly, wherein the thermoelectric assembly comprises a plurality of thermoelectric plates; and the thermoelectric assembly is configured to cool a patient skin target tissue; and an electronic assembly that is configured to energize the thermoelectric assembly, wherein the electronic assembly is electrically interconnected to the thermoelectric assembly; and wherein the head section is configured to support or contain the thermoelectric assembly. 
     In another embodiment, the thermoelectric anesthetic cooling device of is an intra-oral device. In yet another embodiment, the cooling device is an extra-oral device. 
     In yet another embodiment, the thermoelectric anesthetic cooling device comprises a continuous body; and wherein the handle, the head section, and the distal head end together comprise a single piece of material. 
     In still another embodiment, the thermoelectric assembly comprises a plurality of thermoelectric plates that comprises at least one inner thermoelectric plate; at least one outer thermoelectric plate; and a layer of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein the layer is disposed between the at least one inner thermoelectric plate and the at least one outer thermoelectric plate. 
     In one embodiment, at least one outer thermoelectric plate provides cooling, and wherein a user contacts a patient&#39;s target skin tissue with the at least one outer thermoelectric plate. 
     In another embodiment, the plurality of thermoelectric plates comprises ceramic, glass, porcelain, or composite polymer; and In one embodiment, the plurality of thermoelectric plates comprises ceramic, glass, porcelain, or composite polymer; and the thermoelectric plates are cascaded, are in a multi-stage thermoelectric cooler, or are stacked on top of each other. In yet another embodiment, the heat generated during operation of the plurality of thermoelectric plates is dissipated by a first thermally conductive layer located within interior of the body; and a second thermally conductive layer located on the exterior of the distal head end and the exterior of the handle. 
     In another embodiment, thermoelectric plates are cascaded, are in a multi-stage thermoelectric cooler, or are stacked on top of each other. In yet another embodiment, the heat generated during operation of the plurality of thermoelectric plates is dissipated by a first thermally conductive layer located within interior of the body; and a second thermally conductive layer located on the exterior of the distal head end and the exterior of the handle. 
     In still another embodiment, the first thermally conductive layer comprises copper, aluminum alloys, water-copper heat pipe, or copper heat pipe; and wherein the second thermally conductive layer comprises tellurium copper rod, aluminum, aluminum alloys, copper, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In one embodiment, the plurality of thermally conductive layers comprises tellurium copper rod, aluminum, magnesium and aluminum alloys, polymers, ceramics, fibers, copper, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In yet another embodiment, the device further comprises a heat sink selected from a water-copper heat pipe, or a fan for removing accumulated heat in the thermoelectric assembly. 
     In still one embodiment, the present invention is directed to a method of selective localized cooling of a patient target tissue using a thermoelectric anesthetic cooling, wherein the method comprising energizing the thermoelectric anesthetic cooling device; activating cooling function of the thermoelectric anesthetic cooling device by energizing the plurality of the thermoelectric plates by the electronic assembly; placing a cool surface of the thermoelectric plates against the patient target tissue; cooling the patient target tissue for a desired time and temperature; and removing the device from the patient target tissue. 
     In yet another embodiment, the present invention is directed to a thermoelectric anesthetic cooling device comprising a device body comprising a handle; a distal head end, wherein the distal head end comprises a head section and a neck section; a proximal end; and a plurality of thermally conductive layers for dissipating heat from the cooling device; a thermoelectric assembly, wherein the thermoelectric assembly comprises a plurality of thermoelectric plates; and the thermoelectric assembly is configured to cool a patient skin target tissue; and an electronic assembly configured to energize the thermoelectric assembly, wherein the electronic assembly is electrically interconnected to the thermoelectric assembly; and wherein the handle is configured to support or contain the thermoelectric assembly. In one embodiment, the thermoelectric anesthetic cooling device is an intra-oral device and in another embodiment, the thermoelectric anesthetic cooling device is an extra-oral device. 
     In one embodiment, the thermoelectric anesthetic cooling device comprises a continuous body, wherein the handle, the head section and the distal head end comprise a single piece of material. 
     In another embodiment, the plurality of thermoelectric plates comprises at least one inner thermoelectric plate; at least one outer thermoelectric plate; and a layer of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein the layer is disposed between the at least one inner thermoelectric plate and the at least one outer thermoelectric plate. 
     In one embodiment, the at least one inner thermoelectric plate provides cooling; the at least one inner thermoelectric plate is adjacent to a first thermally conductive layer; and wherein a user contacts a patient&#39;s target skin tissue through a cool surface at the head section of the device. 
     In another embodiment, the plurality of thermoelectric plates comprises ceramic, glass, porcelain or composite polymer, and the thermoelectric plates are cascaded, are in a multi-stage thermoelectric cooler, or are stacked on top of each other. 
     In one embodiment, the heat generated during operation of the plurality of thermoelectric plates is dissipated by a second thermally conductive layer located on the exterior of the distal head end and the exterior of the handle. 
     In one embodiment, the first thermally conductive layer comprises copper, aluminum alloys, water-copper heat pipe, or copper heat pipe. 
     In yet another embodiment, the second thermally conductive layer comprises tellurium copper rod, aluminum, aluminum alloys, copper, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In one embodiment, the plurality of thermally conductive layers comprises tellurium copper rod, aluminum, magnesium and aluminum alloys, polymers, ceramics, fibers, copper, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. In still another embodiment, the cooling device further comprises a heat sink selected from a water-copper heat pipe, and a fan for removing accumulated heat in the thermoelectric assembly. 
     In one embodiment, the present invention is directed to an intra-oral thermoelectric anesthetic cooling device comprising a device body that comprises a handle; a distal head end, wherein the distal head end comprises a head section, and a neck section; a proximal end; and a plurality of thermally conductive layers for dissipating heat from the thermoelectric anesthetic cooling device; and wherein the body comprises a continuous body, and wherein the handle, the head section and the distal head end comprise a single piece of material. In one embodiment, the cooling device further comprises a thermoelectric assembly, wherein the thermoelectric assembly comprises a plurality of thermoelectric plates, wherein the plurality of thermoelectric plates comprises at least one inner thermoelectric plate; at least one outer thermoelectric plate; and a layer of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein the layer is disposed between the at least one inner thermoelectric plate and the at least one outer thermoelectric plate. 
     In one embodiment, the at least one outer thermoelectric plate provides cooling, and wherein a user contacts a patient&#39;s skin target tissue through the at least one outer thermoelectric plate; and the thermoelectric assembly is to configured to cool a patient&#39;s target skin surface. The cooling device further comprises an electronic assembly configured to energize the thermoelectric assembly, wherein the electronic assembly is electrically interconnected to the thermoelectric assembly; and wherein the head section is configured to support or contain the thermoelectric assembly. 
     In another embodiment, the plurality of thermoelectric plates comprises ceramic, glass, porcelain or composite polymer; and the thermoelectric plates are cascaded, are in a multi-stage thermoelectric cooler, or are stacked on top of each other. 
     In still another embodiment, the heat generated during operation of the plurality of thermoelectric plates is dissipated by a first thermally conductive layer located within interior of the body; and a second thermally conductive layer located on the exterior of the distal head end and the exterior of the handle. 
     In one embodiment, the first thermally conductive layer comprises copper, aluminum alloys, water-copper heat pipe, or copper heat pipe; and wherein the second thermally conductive layer comprises tellurium copper rod, aluminum, aluminum alloys, copper, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In another embodiment, the plurality of thermally conductive layers comprises tellurium copper rod, aluminum, magnesium and aluminum alloys, copper, polymers, ceramics, fibers, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In one embodiment, the cooling device further comprises a heat sink selected from a water-copper heat pipe, and a fan for removing accumulated heat in the thermoelectric assembly. 
     In still another embodiment, the present invention is directed to an intra-oral thermoelectric anesthetic cooling device comprising a device body that comprises a handle; a distal head end, wherein the distal head end comprises a head section and a neck section; a proximal end; and a plurality of thermally conductive layers for dissipating heat from the cooling device; and wherein the body comprises a continuous body, and wherein the handle, the head section and the distal head end comprise a single piece of material; and a thermoelectric assembly, wherein the thermoelectric assembly comprises a plurality of thermoelectric plates. 
     In an embodiment, the plurality of thermoelectric plates comprises at least one inner thermoelectric plate; at least one outer thermoelectric plate; and a layer of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein the layer is disposed between the inner thermoelectric plates and the outer thermoelectric plates. In an embodiment, the at least one inner thermoelectric plate provides cooling, the at least one inner thermoelectric plate is adjacent to a first thermally conductive layer; and wherein a user contacts the patient&#39;s target skin tissue through a cool surface at the head section of the device. 
     In yet another embodiment, the thermoelectric assembly is configured to cool a patient&#39;s target skin surface. In an embodiment, the cooling device further comprises an electronic assembly configured to energize the thermoelectric assembly, wherein the electronic assembly is electrically interconnected to the thermoelectric assembly; and wherein the handle is configured to support or contain the thermoelectric assembly. 
     In one embodiment, the plurality of thermoelectric plates comprises ceramic, glass, porcelain or composite polymer, and the thermoelectric plates are cascaded, are in a multi-stage thermoelectric coolers, or are stacked on top of each other. 
     In another embodiment, the heat generated during operation of the plurality of thermoelectric plates is dissipated by a second thermally conductive layer located on the exterior of the distal head end and the exterior of the handle. In one embodiment, the first thermally conductive layer comprises copper, aluminum alloys, water-copper heat pipe, or copper heat pipe. In another embodiment, the second thermally conductive layer comprises tellurium copper rod, aluminum, aluminum alloys, copper, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In one embodiment, the plurality of thermally conductive layers comprises tellurium copper rod, aluminum, magnesium and aluminum alloys, copper, polymers, ceramics, fibers, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In yet another embodiment, the cooling device further comprises a heat sink selected from a water-copper heat pipe, and a fan for removing accumulated heat in the thermoelectric assembly. 
     In yet another embodiment, the present invention is directed to an extra-oral thermoelectric anesthetic cooling device comprising a device body comprising a handle; a distal head end, wherein the distal head end comprises a head section, and a neck section; a proximal end; and a plurality of thermally conductive layers for dissipating heat from the cooling device; and wherein the body comprises a continuous body, and wherein the handle, the head section and the distal head end comprise a single piece of material. In one embodiment, the cooling device further comprises a thermoelectric assembly, wherein the thermoelectric assembly comprises a plurality of thermoelectric plates, wherein the plurality of thermoelectric plates comprises at least one inner thermoelectric plate; at least one outer thermoelectric plate; and a layer of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein the layer is disposed between the at least one inner thermoelectric plate and the at least one outer thermoelectric plate. 
     In an embodiment, the at least one outer thermoelectric plate provides cooling, and wherein a user contacts the patient&#39;s target skin tissue through the at least outer thermoelectric plate. In one embodiment, thermoelectric assembly is configured to cool a patient&#39;s target skin surface. In one embodiment, the cooling device further comprises an electronic assembly configured to energize the thermoelectric assembly, wherein the electronic assembly is electrically interconnected to the thermoelectric assembly; and the head section is configured to support or contain the thermoelectric assembly. 
     In one embodiment, the plurality of thermoelectric plates comprises ceramic, glass, porcelain or composite polymer; and the thermoelectric plates are cascaded, are in a multi-stage thermoelectric cooler, or are stacked on top of each other. In one embodiment, the heat generated during operation of the plurality of thermoelectric plates is dissipated by a first thermally conductive layer located within interior of the body; and a second thermally conductive layer located on the exterior of the distal head end and the exterior of the handle. 
     In one embodiment, the first thermally conductive layer comprises copper, aluminum alloys, water-copper heat pipe, or copper heat pipe; and wherein the second thermally conductive layer comprises tellurium copper rod, aluminum, aluminum alloys, copper, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In yet another embodiment, the plurality of thermally conductive layers comprises tellurium copper rod, aluminum, magnesium and aluminum alloys, copper, polymers, ceramics, fibers, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. In one embodiment, the cooling device further comprises a heat sink selected from a water-copper heat pipe, and a fan for removing accumulated heat in the thermoelectric assembly. 
     In still one embodiment, the present invention is directed to an extra-oral thermoelectric anesthetic cooling device comprising a device body comprising a handle; a distal head end, wherein the distal head end comprises a head section and a neck section; a proximal end; and a plurality of thermally conductive layers for dissipating heat from the cooling device; and wherein the body comprises a continuous body, and wherein the handle, the head section and the distal head end comprise a single piece of material. In one embodiment, the cooling device further comprises a thermoelectric assembly, wherein the thermoelectric assembly comprises a plurality of thermoelectric plates, wherein the plurality of thermoelectric plates comprises at least one inner thermoelectric plate; at least one outer thermoelectric plate; and a layer of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein the layer is disposed between the at least one inner thermoelectric plate and the at least one outer thermoelectric plate, wherein the at least one inner thermoelectric plate provides cooling; the at least one inner thermoelectric plate is adjacent to a first thermally conductive layer; and wherein a user contacts the patient&#39;s target skin tissue through a cool surface at the head section of the device. 
     In one embodiment, the thermoelectric assembly is configured to cool a patient&#39;s skin target surface; and the cooling device further comprises an electronic assembly configured to energize the thermoelectric assembly, wherein the electronic assembly is electrically interconnected to the thermoelectric assembly, wherein the handle is configured to support or contain the thermoelectric assembly. 
     In one embodiment, the plurality of thermoelectric plates comprises ceramic, glass, porcelain or composite polymer, and the thermoelectric plates are cascaded, are in a multi-stage thermoelectric coolers, or are stacked on top of each other. 
     In yet another embodiment, the heat generated during operation of the plurality of thermoelectric plates is dissipated by a second thermally conductive layer located on the exterior of the distal head end and the exterior of the handle. In one embodiment, the first thermally conductive layer comprises copper, aluminum alloys, water-copper heat pipe, or copper heat pipe. In another embodiment, the second thermally conductive layer comprises tellurium copper rod, aluminum, copper, aluminum alloys, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In one embodiment, the plurality of thermally conductive layers comprises tellurium copper rod, aluminum, magnesium and aluminum alloys, copper, polymers, ceramics, fibers, beryllium oxide, diamond, aluminum nitride, or one or more combinations thereof. 
     In one embodiment, the cooling device further comprises a heat sink selected from a water-copper heat pipe, and a fan for removing accumulated heat in the thermoelectric assembly. 
     These and other benefits, advantages and features of the present invention will become more full apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Non-limiting and non-exhaustive embodiments of the present embodiments are described with reference to the following figures, wherein like reference numerals refer to like parts throughout the various views unless otherwise specified. 
         FIG. 1  depicts a top perspective view of an intra-oral thermoelectric anesthetic cooling device including a device body comprising a proximal gripping end and a distal head end with the thermoelectric assembly in the head, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 2  depicts a bottom perspective view of an intra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly in the head, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 3  depicts a cross-sectional view of an intra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly in the head, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 4  depicts a cross-sectional view of an intra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 5  depicts a cross-sectional view of an intra-oral thermoelectric anesthetic cooling device with a cavity within the body according to an exemplary embodiment of the present invention. 
         FIG. 6  depicts a cross-sectional view of the distal head portion of the intra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly within the distal head according to an exemplary embodiment of the present invention. 
         FIG. 7  depicts a cross-sectional view of the distal head portion of the intra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly within the handle according to an exemplary embodiment of the present invention. 
         FIG. 8  depicts a perspective view of an extra-oral thermoelectric anesthetic cooling device including a device body comprising a proximal gripping end and a distal head end with the thermoelectric assembly, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 9  depicts a bottom perspective view of an extra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly in the head, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 10  depicts a cross-sectional view of an extra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 12  depicts a cross-sectional view of an extra-oral thermoelectric anesthetic cooling device with a cavity within the body according to an exemplary embodiment of the present invention. 
         FIG. 13  depicts a cross-sectional view of an extra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly in the handle, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
         FIG. 14  depicts a cross-sectional view of an extra-oral thermoelectric anesthetic cooling device with the thermoelectric assembly within the distal head end, temperature controller, and power supply within the body according to an exemplary embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The intra-oral and extra-oral thermoelectric anesthetic cooling devices of the present invention provide transient nerve cooling block of the peripheral nerves system. The thermoelectric cooling devices of the present invention allow for temperature controlled cooling of the skin/epidermis or mucous membrane/mucosa, to alleviate pain associated with medical treatment such as injections and skin ablation applied to the human body. The thermoelectric anesthetic cooling devices of the present invention provide a novel method to provide pain relief using thermoelectric cooling for medical procedures, such as pre-anesthetic and post-anesthetic therapy. This pre-anesthetic, post-anesthetic therapy cooling device takes advantage of the Peltier effect to create a heat flux between the junction of two different types of materials. The Peltier effect is the presence of heating or cooling at an electrified junction of two different conductors. The Peltier cooler is a solid-state active heat pump, which transfers heat from one side to the other, with consumption of electrical energy, depending on the direction of the current. 
     In general, a thermoelectric cooler (TEC) comprises two sides, and when DC electricity flows through the device (i.e., the device is energized), it brings heat from one side to the other, so that one side becomes cooler while the other side becomes hotter. The “hot” side is coupled to the head of the thermoelectric anesthetic cooling device. The neck and body of the device is used as a heat sink so that it remains at ambient temperature, while the cool side temperature is reduced below room temperature. The “cool” side can be placed against the epidermis or mucosa to achieve a transient conduction block in the peripheral nerves that does not result in onset firing. Partial conduction block is found for temperatures below 14° C., and complete nerve conduction block is achieved for temperatures below 6° C. This provides an analgesic effect to reduce or prevent pain from injections and inflammation. Also, the cooling device minimizes bruising associated with injectable fillers, and pain from a variety of laser treatments. 
     Two unique semiconductors, one N-type and one P-type, are used because they need to have different electron densities. The semiconductors are placed thermally in parallel to each other, and electrically in series, then joined with a thermally conducting plate on each side. When a voltage is applied to the free ends of the two semiconductors, there is a flow of DC current across the junction of the semiconductors, thereby causing a temperature difference. 
     A TEC device does not contain any moving parts so maintenance is required less frequently, while temperature control within fractions of a degree can be maintained. Furthermore, a TEC device has a flexible shape (form factor), and in particular, it can have a very small size, having a long life with mean time between failures (MTBF) exceeding 100,000 hours, and is controllable via changing the input voltage/current. 
     The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. As used herein, the word “exemplary” means “serving as an example, instance, or illustration.” Thus, any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. All of the embodiments described herein are exemplary embodiments provided to enable persons skilled in the art to make or use the invention and not to limit the scope of the invention that is defined by the claims. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary, or the following detailed description. 
     As used herein, and unless the context dictates otherwise, the term “thermoelectric cooling device” is intended to include an intra-oral thermoelectric anesthetic cooling device, cooling device, and device. Therefore, the terms “thermoelectric cooling device”, “intra-oral thermoelectric anesthetic cooling device”, “cooling device” and “device”, may be used interchangeably. 
     As used herein, and unless the context dictates otherwise, the term “thermoelectric cooling device” is intended to include an extra-oral thermoelectric anesthetic cooling device, cooling device, and device. Therefore, the terms “thermoelectric cooling device”, “extra-oral thermoelectric anesthetic cooling device”, “cooling device”, and “device”, may be used interchangeably. 
     As used herein, and unless the context dictates otherwise, the term “switch” is intended to include button. Therefore, the terms “switch”, and “button”, may be used interchangeably. 
     As used herein, and unless the context dictates otherwise, the term “device body” is intended to include body. Therefore, the terms “device body”, and “body”, may be used interchangeably. 
     As used herein, and unless the context dictates otherwise, the term “thermoelectric assembly” is intended to include thermoelectric cooler. Therefore, the terms “thermoelectric assembly”, and “thermoelectric cooler”, may be used interchangeably. 
     As used herein, and unless the context dictates otherwise, the term “handle” is intended to include gripping portion. Therefore, the terms “handle”, and “gripping portion”, may be used interchangeably. 
     In this description, reference is made to the drawings, wherein like parts are designated with like reference numerals throughout. As used in the description herein and throughout, the meaning of “a,” “an,” and “said” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “into” and “on”, unless the context clearly dictates otherwise. 
     As used herein, the term “about” in conjunction with a numeral refers to a range of that numeral starting from 10% below the absolute of the numeral to 10% above the absolute of the numeral, inclusive. 
     An exemplary configuration of the thermoelectric cooling device is schematically depicted in  FIG. 1 , in which an intra-oral thermoelectric anesthetic cooling device  105  comprises body  128  including handle  104 , distal head end  103 , and proximal end  111 . Distal head end  103  comprises head section  102 , and a neck section  129 . Distal head end  103  is sized and configured to be inserted into the mouth of a patient. In one embodiment, head section  102  comprises a thermoelectric assembly  112  that allows a user to cool a patient&#39;s intra oral tissue. In another embodiment, thermoelectric assembly  112  comprises thermoconductive coating for hygienic purposes. In an alternative embodiment, head section  102  comprises a thermoelectric assembly of thermoelectric coolers  112  stacked. In one embodiment, handle  104  comprises a thickness of about 15 to about 50 mm, and in one or more embodiments, a thickness of about 14 to about 35 mm. In general, dimensions for handle  104  are used that provide comfort for a user (i.e., a clinician). In one embodiment, neck section  129  and head section  102  are thinner than handle  104  and comprises a thickness of about 1 to about 30 mm. In one embodiment, head section  102  that comes interfaces patient&#39;s mucosa comprises a diameter of about 2 to about 20 mm, neck section  129  comprises a diameter of about 60 mm to 80 mm; and handle  104  is about 10 to about 30 mm wide and is about 150 to about 250 mm long. 
     In one or more embodiments, device body  128  comprises a suitable thermally conductive material, including but not limited to, thermally conductive metals (e.g., aluminum, copper, magnesium and aluminum alloy), fibers and/nanomaterials, ceramics and polymers. 
     In one embodiment, all or a portion of the exterior surface of device body  128  includes one or more coatings to protect the surface and/or to facilitate cleaning and/or sterilizing of the cooling device  105  (not shown). In one embodiment, fluoropolymer coatings such as Polytetrafluorethylene (PTFE) may be used due to the non-sticky properties. In another embodiment, the exterior surface of device body  128  is coated with a scratch resistant coating (not shown). The coating layers may be applied by chemical or plasma vapor operation, or other techniques known in the art. In one embodiment, scratch resistant coating comprises metal oxide or metal nitride or the same as the thermally conductive layer. 
     In an embodiment, body  128  comprises temperature controller  116  including buttons  116   a  and  116   b , temperature display  108 , power button  115   a , optional vibration switch  107 , timer/mode button  115   b , warning indicator lights  109 , and timing indicator lights  110 . In one embodiment, proximal end  111  comprises a screwable lid for inserting batteries  114   a  and  114   b  (as shown in  FIG. 3 ). In one embodiment, temperature controller  116  allows a temperature range from about 21° C. to about 0° C. to eliminate the risk of frostbite on the patient&#39;s tissue. In one exemplary embodiment, as depicted in  FIG. 1 , buttons  116   a  and  116   b  increase and decrease, respectively, the temperature according to the user&#39;s need. 
     In one embodiment, thermoelectric anesthetic cooling device  105  comprises an electronic assembly  117  located within a cavity  133  of body  128  (as shown in  FIG. 5 ). In one embodiment, cavity  133  comprises a rim (not shown) that is configured to form a secure fit with a corresponding rim of electronic assembly  117  (not shown) to ensure proper sealing of cavity  133 . Electronic assembly  117  comprises batteries  114   a  and  114   b , circuit board  127 , and power button  115   a . In this exemplary embodiment, electronic assembly  117  is used to energize thermoelectric cooling device  105 . Electronic assembly  117  allows a user (i.e., a clinician) to turn on/off device  105  by using power button  115   a . In an alternative embodiment, power can be provided by a power cord (not shown) that is coupled to electronic assembly  117 , located in proximal end  111 . In an embodiment, button  115   b  provides a user options for different mode and time for operating device  105 . In one embodiment, thermoelectric cooling device  105  comprises batteries  114   a  and  114   b  with or without the ability to adapt to a charging station, or a cord connected to a power outlet with different adapters. In one embodiment, rechargeable batteries  114   a  and  114   b  provide power to electronic assembly  117 . In one or more exemplary embodiments, holes  122   a  and  122   b  allow electronic assembly  117  to be secured to body  128  by using screws (see  FIG. 3 ). 
     Circuit board  127 , power button  115   a , power source (such as batteries  114   a  and  114   b , internal or external power source, plug), electronic assembly  117  and thermoelectric assembly  112  are all electronically interconnected. 
       FIG. 2  is an exemplary embodiment of the posterior view of intra-oral device  105  depicting thermoelectric cooling plates of thermoelectric assembly  112 , distal head end  103 , head section  102 , optional vibration switch  107 , handle  104 , and proximal end  111 . In an embodiment, head section  102  supports or contains thermoelectric assembly  112 . In one embodiment, optional vibration switch  107  provides additional pain reduction for the patient&#39;s target tissue. 
     In one exemplary embodiment of the present invention, the power input and thermoelectric output of the thermoelectric assembly  112  are ramped up over a period of time. In another exemplary embodiment, temperature controller  116  is designed to provide many possible ramp-up times and temperature ranges (e.g., about 15° C. to about 0° C.). In one or more exemplary embodiments, a ramp-up time may be appropriate for one scenario, but not for another. In one embodiment, thermoelectric cooling device  105  may include circuitry configured to allow a user to choose a ramp time for ramping-down the temperature of the thermoelectric cooling device (not shown). 
     In one embodiment, electronics assembly  117  comprises a plurality of selectable ramp-up times within a range from about 5 seconds to about 10 minutes. In this embodiment, a user selects one of the plurality of ramp-up times and thermoelectric cooling device  105  incrementally increases power input to reach the selected temperature in the selected period of time (not shown). 
     In one exemplary embodiment, body  128  comprises a continuous body, also known as a unibody, wherein handle  104 , head section  102  and distal head end  103  comprise a single piece of material. In one embodiment, body  128  comprises one or more thermally conductive body materials (e.g., thermally conductive metal, polymer, ceramic, and/or thermally conductive ceramic fibers or nanomaterials). In this embodiment, the unibody provides a seamless body  128  and maximizes heat conduction into body  128 . 
     In one embodiment, thermoelectric cooling device  105  comprises an elongated shaped body to facilitate use of cooling device  105  in the mouth of a patient. One of ordinary skill in the art will appreciate that thermoelectric cooling device  105  may have other shapes suitable for use in cooling the patient&#39;s epidermis/mucosa within, or even outside, a patient&#39;s mouth. For example, thermoelectric anesthetic cooling device  105  having a gun-like configuration may incorporate any of the features disclosed herein. In general, any contra-angled configuration may be used in connection with the features described herein. In one or more embodiments, thermoelectric anesthetic cooling device  105  may have a wire that it is directly compatible with standard power outlets (including all relevant male adapters for ex-US use), a battery pack (i.e.,  114   a  and  114   b ) that is housed inside proximal end  111  of handle  104 , or the thermoelectric anesthetic cooling device may have a rechargeable docking station. 
     In another embodiment, thermoelectric anesthetic cooling device  105  comprises a shape suitable for use in an intra-orally or extra-orally cooling device. In an embodiment, thermoelectric plates  123  comprise different sizes, shapes (square or round) depending on the use. In one or more embodiments, multiple adaptors are used that reside on the head of thermoelectric plates  123  (not shown). The adaptors may comprise metal or other appropriate substance for better contact with the mucosa/epidermis. 
     In yet another embodiment, the entirety or a portion of body  128  is produced from a thermally conductive body material so long as device body  128  has sufficient thermal conductivity to dissipate the desired heat generated by the thermoelectric unit during use (i.e., with the device set to a maximum user selectable coldest temperature output). In this embodiment, device body  128  provides heat dissipation, thus the need for a configuration to accommodate a separate heat sink is eliminated for thermoelectric anesthetic cooling device  105 . 
     In an exemplary embodiment, as depicted in  FIGS. 3 and 6 , thermoelectric assembly  112  resides within distal head end  103 , in particular in head section  102 . In this embodiment, thermoelectric assembly  112  comprises inner ceramic plate  123   a  and outer ceramic plate  123   b , and layer  124  (as shown in  FIG. 6 ) of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein layer  124  is disposed between inner ceramic plate  123   a  and outer ceramic plate  123   b . In one or more embodiments, ceramic plates  123   a  and  123   b  comprise glass, porcelain or composite polymer. In an alternative embodiment, thermoelectric assembly  112  comprises a plurality of thermoelectric plates, such as ceramic plates that are cascaded, are in a multi-stage thermoelectric cooler, or are stacked on top of each other (not shown). In one embodiment, power supplied by rechargeable batteries  114   a  and  114   b , through wires  118   a  and  118   b  located in electronic assembly  117 , charge carriers and flow to layer  124 , giving rise to the Peltier effect, such that cooling is provided at outer ceramic plate  123   b  and heating is provided at inner ceramic plate  123   a . A user (i.e., clinician) interfaces target tissue on the patient&#39;s skin through outer ceramic plate  123   b  through cold surface  125 , as depicted in  FIG. 6 . In an embodiment, thermoelectric assembly  112  comprises a temperature sensor attached to outer ceramic plate  123   b  located on head section  102  electrically coupled to the terminal block (not shown). The heat generated in inner ceramic plate  123   a  is dissipated from thermoelectric assembly  112  using first thermally conductive layer  113  located within interior of body  128  (heat sink), and second thermally conductive layer located on the exterior of distal head end  103  and the exterior of handle  104 . In one embodiment, the peripheral nerve in the skin/mucosa is cooled from normal body temperature (about 37° C.) down to about 5° C. 
     In one or more exemplary embodiments, first thermally conductive layer  113  comprises materials with high thermal conductivity such as copper, aluminum alloys, and copper heat pipe with or without water. In one embodiment, first thermally conductive layer  113  comprises a flat water-copper heat pipe, which allows a smaller head section  102 , while keeping a low delta T in thermoelectric assembly  112 . This embodiment provides the thermal mass to absorb the heat transferred from the target&#39;s tissue as well as the heat generated by the operation of thermoelectric assembly  112  during a 2 minute treatment without an excessive temperature rise in thermoelectric anesthetic cooling device  105 . In this embodiment, a cylindrical heat sink is used as second thermally conductive layer  126 . Second thermally conductive layer  126  comprises a 19 mm tellurium copper rod. Inner ceramic plate  123   a  is attached to a flat water-copper heat pipe using a semi-flexible silver-filled epoxy to allow different materials to contract at different rates without inducing excessive stress. In one or more exemplary embodiments, second thermally conductive layer  126  comprises materials with high thermal conductivity such as aluminum, copper, or aluminum alloys plus an additional layer of conductive material. In these embodiments, the surface area of second thermally conductive layer  126  is sufficiently large such that a majority (e.g., substantially all) of the heat conducted away from the thermoelectric assembly  112  by second thermally conductive layer  126  is transferred to device body  128 . 
     In one or more embodiments, second thermally conductive layer  126  may comprise a separate piece that is secured to a portion of device body  128  and may have a thickness ranging from about 100 microns to about 1.5 mm and is produced from one or more highly thermally conductive materials such as, but not limited to, beryllium oxide, diamond, aluminum nitride, or one or more combinations of these materials. 
     In another embodiment, second thermally conductive layer  126  may comprise a very thin layer applied over at least a portion of device body  128  (e.g., by chemical or plasma vapor deposition or plasma flame spraying). In such an embodiment, the thickness of second thermally conductive layer  126  may be only about 0.05 micron to about 50 microns. The thickness and surface area of second thermally conductive layer  126  is sufficient to ensure that most, if not essentially all, of the waste heat generated by thermoelectric assembly  112  is transferred through thermally conductive layer  126  and dissipated into body  128  material. At moderate to low operating temperatures, second thermally conductive layer  126  can dissipate heat from the substrate of thermoelectric assembly at the same rate that heat is dissipated into the thermoelectric assembly  112  substrate from thermoelectric assembly  112  thereby allowing continuous moderate to low temperature operation. 
     In another embodiment, intra-oral thermoelectric cooling device  105  may contain water or a fan as a heat sink to remove accumulated heat in thermoelectric assembly  112 . 
     In one embodiment, thermoelectric assembly  112  comprises different sized thermoelectric plates, types (e.g., high performance, micro, multi-stage, series-parallel, and standard) and shapes, and a thermally conductive layer (not shown). In another embodiment, thermally conductive layer may comprise a separate, relatively thick member that is secured to body, rather than being a very thin layer applied by vapor deposition or plasma flame spraying techniques. In a further embodiment, a relatively thin thermally conductive layer is applied to cooling device  105  of the intra-oral thermoelectric anesthetic cooling device (e.g., by vapor deposition or plasma flame spraying). 
     In one or more embodiments, the exterior surface of cooling device  105  may be coated with one or more coatings to protect the surface and/or facilitate cleaning and/or sterilizing thermoelectric anesthetic cooling device  105 . In one or more embodiments, a thermally conductive grease, gel, or adhesive can include a filler material to improve thermal conductivity. 
     In an exemplary embodiment, as depicted in  FIGS. 4, and 7 , thermoelectric assembly  112  resides within body  128 . In this embodiment, thermoelectric assembly  112  resides in handle  104 . In this embodiment, thermoelectric assembly  112  comprises ceramic plates  123   a  and  123   b , and layer  124  (as shown in  FIG. 4 ) of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein layer  124  is disposed between ceramic plates  123   a  and  123   b . In an alternative embodiment, thermoelectric assembly  112  comprises a plurality of thermoelectric plates, such as ceramic plates that are cascaded, are in a multi-stage thermoelectric cooler, or are stacked on top of each other (not shown). In one embodiment, power supplied by rechargeable batteries  114   a  and  114   b , through wires  118   a  and  118   b  located in electronic assembly  117 , charge carriers and flow to layer  124 , giving rise to the Peltier effect, such that cooling is provided at inner ceramic plate  123   b  and heating is provided at outer ceramic plate  123   a . In this embodiment, first thermally conductive layer  113  is located in head section  102  and extends through part of handle  104 , as shown in  FIG. 4 . Furthermore, first thermally conductive layer  113  is adjacent to inner ceramic plate  123   b . In this embodiment, cooling of inner ceramic plate  123   b  is conducted through first thermally conductive layer  113  to head section  102 . A user (i.e., clinician) interfaces target tissue on the patient&#39;s mucosa through cold surface  130 , as depicted in  FIG. 7 . In an embodiment, thermoelectric assembly  112  comprises a temperature sensor attached to inner ceramic plate  123   b  and electrically coupled to the terminal block (not shown). The heat generated in outer ceramic plate  123   a  is dissipated from thermoelectric assembly  112  using second thermally conductive layer  126  located on the exterior of distal head end  103  and the exterior of handle  104 . In one embodiment, the peripheral nerve in the skin/mucosa is cooled from normal body temperature (about 37° C.) down to about 5° C. 
     In an alternative embodiment, thermoelectric assembly  112  comprises 2 sets of ceramic plates  123   a  and  123   b , located above first thermally conductive layer  113  and below first thermally conductive layer  113  (not shown). In another embodiment, thermoelectric assembly  112  comprises one set of ceramic plates  123   a  and  123   b  located either above first thermally conductive layer  113  or below first thermally conductive layer  113  (not shown). 
     In one or more exemplary embodiments, first thermally conductive layer  113  comprises copper, aluminum alloys, and copper heat pipe with or without water. In one or more exemplary embodiments, second thermally conductive layer  126  comprises aluminum, copper, aluminum alloys plus an additional layer of conductive material. In these embodiments, the surface area of second thermally conductive layer  126  is sufficiently large that a majority (e.g., substantially all) of the heat conducted away from the thermoelectric assembly  112  by second thermally conductive layer  126  is transferred to device body  128 . 
     In another embodiment, thermoelectric cooling device may contain water or a fan as a heat sink to remove accumulated heat in thermoelectric assembly  112 . 
     The present invention also provides a method of selective localized cooling of patient&#39;s target tissue by using intra-oral thermoelectric cooling device  105 . In an exemplary embodiment, batteries  114   a  and  114   b  of intra-oral thermoelectric cooling device  105  are charged by using the plug charger into the electrical outlet or placing thermoelectric cooling device  105  onto a charging dock station which is connected to an outlet. A single use hygienic barrier sleeve is placed onto head section  102  of cooling device  105 . In an embodiment, where thermoelectric assembly  112  is within distal head end  103 , head section  102  is then placed onto the target tissue (i.e., the intra-oral tissue of patient&#39;s skin) that needs to be cooled (i.e., anesthetized). Power button  115   a  is then turned on to start thermoelectric cooling device  105 . Optional vibration may used at this point by pressing vibration switch  107 . Desired temperature is reached by using  116   a  (to increase the temperature) or by using  116   b  (to decrease the temperature). The operation time is set by using time/mode button  115   b . Timing indicator light  110  turns green to show desired time interval. Thermoelectric cooling device  105  operates at 45-second bursts and not continuously. Button  115   b  shows the power level; an orange light in warning indicator lights  109  indicates a low battery level and a red light indicates thermoelectric cooling device  105  needs to be cooled. 
     The current provided by the batteries  114   a  and  114   b  in the electronic assembly  117  travels through device  105  and is transferred to the thermoelectric assembly  112  by wires  118   a  and  118   b , causing outer ceramic thermoelectric plate  123   b  to cool down to 4° C. (or other desired temperature as indicated on temperature display  108 ). The user (i.e., clinician) places cold surface (i.e.,  125 ) of outer ceramic plate  123   b  in contact with skin surface of the target tissue, causing the target tissue to become numb. The aforementioned method is repeated as needed for any site in the mouth of the patient. Power button  115   a  is pressed to turn intra-oral thermoelectric cooling device  105  off. The hygienic sleeve is then removed and cooling device  105  is wiped down with sanitizing solution before applying the device to the next patient. 
     An exemplary configuration of the thermoelectric cooling device is schematically depicted in  FIG. 8 , in which an extra-oral thermoelectric anesthetic cooling device  227  comprises body  205  including handle  204 , distal head end  203 , and proximal end  211 . distal head end  203  comprises head section  202 , and neck section  229 . In one embodiment, head section  202  comprises an thermoelectric cooling assembly of thermoelectric cooler  212  that allows a user to cool a patient&#39;s skin surface. In another embodiment, thermoelectric cooler  212  comprises thermoconductive coating for hygienic purposes. In an alternative embodiment, head section  202  comprises an thermoelectric cooling assembly of thermoelectric coolers  112  stacked. In one embodiment, handle  204  comprises a thickness of about 15 to about 50 mm, and in one or more embodiments, a thickness of about 14 to about 35 mm. In general, dimensions for handle  204  are used that provide comfort for a user (i.e., a clinician). In one embodiment, neck section  229  and head section  202  are thinner than handle  204  and comprises thickness of about 20 to about 35 mm. In one embodiment, head  202  that interfaces with patient&#39;s epidermis is about 10 mm to about 50 mm, neck section  229  is about 10 to about 60 mm; and handle  204  is about 100 to about 120 mm long, is about 20 to about 35 mm wide. In another embodiment, handle  240  is about 150 to about 180 mm long. 
     In one or more embodiments, device body  205  comprises a suitable thermally conductive material, including but not limited to, thermally conductive metals (e.g., aluminum, copper, magnesium and aluminum alloy), fibers and/nanomaterials, ceramics and polymers. 
     In one embodiment, all or a portion of the exterior surface of device body  205  includes one or more coatings to protect the surface and/or to facilitate cleaning and/or sterilizing of the extra oral cooling device  227  (not shown). In one embodiment, fluoropolymer coatings such as Polytetrafluorethylene (PTFE) may be used due to the non-sticky properties. In another embodiment, the exterior surface of device body  205  is coated with a scratch resistant coating (not shown). The coating layers may be applied by chemical or plasma vapor operation, or other techniques known in the art. In one embodiment, scratch resistant coating comprises metal oxide or metal nitride or the same as the thermally conductive layer. 
     In an embodiment, device body  205  comprises temperature controller  216  including buttons  216   a  and  216   b , temperature display  208 , power button  228   a , vibration switch  207 , timer/mode button  228   b , warning indicator lights  209 , and timing indicator lights  210 . In one embodiment, proximal end  211  comprises a screwable lid for inserting batteries  214   a  and  214   b  (as shown in  FIG. 9 ). In one embodiment, temperature controller  216  allows a temperature range from about 21° C. to about 0° C. to eliminate the risk of frostbite on the patient&#39;s skin tissue. In one exemplary embodiment, as depicted in  FIG. 8 , buttons  216   a  and  216   b  increase and decrease, respectively, the temperature according to the user&#39;s need. 
     In one embodiment, thermoelectric anesthetic cooling device  227  comprises an electronic assembly  217  located within cavity  233  of body  205  (as shown in  FIG. 12 ). In one embodiment, cavity  233  comprises a rim (not shown) that is configured to form a secure fit with a corresponding rim of electronic assembly  217  (not shown) to ensure proper sealing of cavity  233 . In an embodiment, electronic assembly  217  comprises batteries  214   a  and  214   b , circuit board  232 , and power button  228   a . In this exemplary embodiment, electronic assembly  217  is used to energize extra-oral thermoelectric cooling device  227 . Electronic assembly  217  allows a user (i.e., a clinician) to turn on/off cooling device  227  by using power button  215   a . In an alternative embodiment, power can be provided by a power cord (not shown) that is coupled to electronic assembly  217 , located in proximal end  211 . In an embodiment, button  215   b  provides a user options for different mode and time for operating extra oral cooling device  227 . 
     Circuit board  232 , power button  228   a , power source (such as batteries  214   a  and  214   b , internal or external power source, plug), electronic assembly  217  and thermoelectric assembly  212  are all electronically interconnected. 
     In an embodiment, extra oral thermoelectric cooling device  227  comprises batteries  214   a  and  214   b  with or without the ability to adapt to a charging station, or a cord connected to a power outlet with different adapters. In one embodiment, rechargeable batteries  214   a  and  214   b  provide power to electronic assembly  217 . 
       FIG. 9  is an exemplary embodiment of the posterior view of extra-oral device  227  depicting thermoelectric cooling plates of thermoelectric assembly  212 , distal head end  203 , head section  202 , optional vibration switch  207 , handle  204 , and proximal end  211 . In an embodiment, head section  202  supports or contains thermoelectric assembly  212 . In one embodiment, optional vibration switch  207  provides additional pain reduction for the target tissue. 
     In one exemplary embodiment of the present invention, the power input and thermoelectric output of the thermoelectric assembly  227  are ramped up over a period of time. In another exemplary embodiment, temperature controller  216  is designed to provide many possible ramp-up times and temperature ranges. In one embodiment, the temperature ranges from about 15 to about 0. In one or more exemplary embodiments, a ramp-up time may be appropriate for one scenario, but not for another. In one embodiment, thermoelectric cooling device  227  may include circuitry configured to allow a user to choose a ramp time for ramping-down the temperature of the thermoelectric cooling device (not shown). 
     In one embodiment, electronics assembly  217  comprises a plurality of selectable ramp-up times within a range from about 5 seconds to about 10 minutes. In this embodiment, a user selects one of the plurality of ramp-up times and thermoelectric cooling device  227  incrementally increases power input to reach the selected temperature in the selected period of time (not shown). 
     In one exemplary embodiment, device body  205  comprises a continuous body, also known as a unibody, wherein handle  204 , head section  202  and distal head end  203  comprise a single piece of material. In one embodiment, body  205  comprises one or more thermally conductive body materials (e.g., thermally conductive metal, polymer, ceramic, and/or thermally conductive ceramic fibers or nanomaterials). In this embodiment, the unibody provides a seamless body  205  and maximizes heat conduction into EX-device body  205 . 
     In one embodiment, thermoelectric cooling device  227  comprises a hand held shaped body to facilitate use of cooling device  227  on the skin of a patient. One of ordinary skill in the art will appreciate that thermoelectric cooling device  227  may have other shapes suitable for use in cooling the patient&#39;s epidermis. For example, extra oral thermoelectric anesthetic cooling device  227  having a gun-like configuration may incorporate any of the features disclosed herein. In general, any contra-angled configuration may be used in connection with the features described herein. In one or more embodiments, thermoelectric anesthetic cooling device  227  may have a wire that it is directly compatible with standard power outlets (including all relevant male adapters for ex-US use), an battery pack (i.e.,  214   a  and  214   b ) that is housed inside proximal end  211  of handle  204 , or the thermoelectric anesthetic cooling device may have a rechargeable docking station. 
     In another embodiment, thermoelectric anesthetic cooling device  227  comprises a shape suitable for use in an or extra-orally cooling device. In an embodiment, thermoelectric plates  223   a  and  223   b  comprise different sizes, shapes (square or round) depending on the use. In one or more embodiments, multiple adaptors are used that reside on the head of thermoelectric plates  223   a  and  223   b  (not shown). The adaptors may comprise metal or other appropriate substance for better contact with the epidermis. 
     In yet another embodiment, the entirety or a portion of body  205  is produced from a thermally conductive body material so long as device body  205  has sufficient thermal conductivity to dissipate the desired heat generated by the thermoelectric unit during use (i.e., with the device set to a maximum user selectable coldest temperature output). In this embodiment, device body  205  provides heat dissipation, thus the need for a configuration to accommodate a separate heat sink is eliminated for thermoelectric anesthetic cooling device  227 . 
     In an exemplary embodiment, as depicted in  FIGS. 11 and 14 , thermoelectric assembly  212  resides within distal head end  203 , in particular in head section  202 . In this embodiment, thermoelectric assembly  212  comprises inner ceramic plates  223   a  and outer ceramic plate  223   b , and layer  224  of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein layer  224  is disposed between ceramic plates  223   a  and  223   b . In one or more exemplary embodiments, ceramic plates  123   a  and  123   b  comprise glass, porcelain or composite polymer. In an alternative embodiment, thermoelectric assembly  212  comprises a plurality of thermoelectric plates, such as ceramic plates that are cascaded, are in a multi-stage thermoelectric coolers, or are stacked up on top of each other (not shown). In one embodiment, power supplied by rechargeable batteries  214   a  and  214   b , through wires  218   a  and  218   b  located in electronic assembly  217 , charge carriers and flow to layer  224 , giving rise to the Peltier effect, such that cooling is provided at outer ceramic plate  223   b  and heating is provided at inner ceramic plate  223   a . A user (i.e., clinician) interfaces target tissue on the patient&#39;s skin through outer ceramic plate  223   b  through cold surface  225 , as depicted in  FIG. 14 . In an embodiment, thermoelectric assembly  212  comprises a temperature sensor attached to outer ceramic plate  123   b  located on head section  102  electrically coupled to the terminal block (not shown). The heat generated in inner ceramic plate  223   a  is dissipated from thermoelectric assembly  212  using first thermally conductive layer  213  located within interior of body  205 , and second thermally conductive layer  215  located on the exterior of distal head end  203  and the exterior of handle  204 . In one embodiment, the peripheral nerve in the skin/mucosa is cooled from normal body temperature (about 37° C.) down to about 5° C. 
     In one or more exemplary embodiments, first thermally conductive layer  213  comprises materials with high thermal conductivity such as copper, aluminum alloys, and copper heat pipe with or without water. In one embodiment, first thermally layer  213  comprises a flat water-copper heat pipe, which allows a smaller head section  202 , while keeping a low delta T in thermoelectric assembly  212 . This embodiment provides the thermal mass to absorb the heat transferred from the target&#39;s tissue as well as the heat generated by the operation of thermoelectric assembly  212  during a 2 minute treatment without an excessive temperature rise in extra oral thermoelectric anesthetic cooling device  227 . In this embodiment, a cylindrical heat sink is used as second outer thermally conductive layer  215 . Second thermally conductive layer  215  comprises a 19 mm tellurium copper rod. Inner ceramic plate  223   a  is attached to a flat water-copper heat pipe using a semi-flexible silver-filled epoxy to allow different materials to contract at different rates without inducing excessive stress. In one or more exemplary embodiments, second thermally conductive layer  215  comprises materials with high thermal conductivity such as aluminum, copper, or aluminum alloys plus an additional layer of conductive material. In these embodiments, the surface area of second thermally conductive layer  215  is sufficiently large such that a majority (e.g., substantially all) of the heat conducted away from thermoelectric assembly  212  by second thermally conductive layer  215  is transferred to device body  205 . 
     In one or more embodiments, second thermally conductive layer  215  may comprise a separate piece that is secured to a portion of device body  205  and may have a thickness ranging from about 100 microns to about 1.5 mm and is produced from one or more highly thermally conductive materials such as, but not limited to, beryllium oxide, diamond, aluminum nitride, or one or more combinations of these materials. 
     In another embodiment, second thermally conductive layer  215  may comprise a very thin layer applied over at least a portion of device body  205  (e.g., by chemical or plasma vapor deposition or plasma flame spraying). In such an embodiment, the thickness of second thermally layer  215  may be only about 0.05 micron to about 50 microns. The thickness and surface area of second thermally conductive layer  215  is sufficient to ensure that most, if not essentially all, of the waste heat generated by thermoelectric assembly  212  is transferred through second thermally conductive layer  215  and dissipated into body  205  material. At moderate to low operating temperatures, second thermally conductive layer  215  can dissipate heat from the substrate of thermoelectric assembly at the same rate that heat is dissipated into thermoelectric assembly  212  substrate from thermoelectric assembly  212  thereby allowing continuous moderate to low temperature operation. 
     In another embodiment, thermoelectric cooling device  227  may contain water or a fan as a heat sink to remove accumulated heat in thermoelectric assembly  212 . 
     In one embodiment, extra-oral thermoelectric assembly  212  comprises different sized thermoelectric plates, types (e.g., high performance, micro, multi-stage, series-parallel or standard) and shapes, and a thermally conductive layer (not shown). In another embodiment, thermally conductive layer may comprise a separate, relatively thick member that is secured to body, rather than being a very thin layer applied by vapor deposition or plasma flame spraying techniques. In a further embodiment, a relatively thin thermally conductive layer is applied to cooling device  227  of the extra-oral thermoelectric anesthetic cooling device (e.g., by vapor deposition or plasma flame spraying). 
     In one or more embodiments, the exterior surface of cooling device  227  may be coated with one or more coatings to protect the surface and/or facilitate cleaning and/or sterilizing thermoelectric anesthetic cooling device  227 . In one or more embodiments, a thermally conductive grease, gel, or adhesive can include a filler material to improve thermal conductivity. 
     In an exemplary embodiment, as depicted in  FIGS. 10 and 13 , thermoelectric assembly  212  resides within body  205 . In this embodiment, thermoelectric assembly  212  resides in handle  204 . In this embodiment, thermoelectric assembly  212  comprises inner ceramic plate  223   a  and outer ceramic plate  223   b , and layer  224  of semiconductor material arranged with spaced apart portions of P-type semiconductor and N-type semiconductor material, wherein layer  224  is disposed between ceramic plates  223   a  and  223   b . In one embodiment, power supplied by rechargeable batteries  214   a  and  214   b , through wires  218   a  and  218   b  located in electronic assembly  217 , charge carriers and flow to layer  224 , giving rise to the Peltier effect, such that cooling is provided at inner ceramic plate  223   a  and heating is provided at outer ceramic plate  223   b . In this embodiment, first thermally conductive layer  213  is located in head section  202  and extends through part of handle  204 , as shown in  FIG. 11 . Furthermore, first thermally conductive layer  213  is adjacent to inner ceramic plate  223   a . A user (i.e., clinician) interfaces target tissue on the patient&#39;s skin through inner ceramic plate  223   a  through cold surface  226 , as depicted in  FIGS. 10 and 13 . In an embodiment, thermoelectric assembly  212  comprises a temperature sensor attached to inner ceramic plate  223   a  electrically coupled to the terminal block (not shown). The heat generated in outer ceramic plate  223   b  is dissipated from thermoelectric assembly  212  using a second thermally conductive layer  215  located on the exterior of distal head end  203  and the exterior of handle  204 . In one embodiment, the peripheral nerve in the skin is cooled from normal body temperature (about 37° C.) down to about 5° C. 
     In one or more exemplary embodiments, first thermally conductive layer  213  comprises copper, aluminum alloys, and copper heat pipe with or without water. In one or more exemplary embodiments, second outer thermally conductive layer  215  comprises aluminum, copper, aluminum alloys plus an additional layer of conductive material. In these embodiments, the surface area of second thermally conductive layer  215  is sufficiently large that a majority (e.g., substantially all) of the heat conducted away from thermoelectric assembly  212  by second thermally conductive layer  215  is transferred to device body  205 . 
     In another embodiment, thermoelectric cooling device may contain water or a fan as a heat sink to remove accumulated heat in thermoelectric assembly  212 . 
     The present invention also provides a method of selective localized cooling of patient&#39;s target tissue by using extra-oral cooling device  227 . In an exemplary embodiment, batteries  214   a  and  214   b  of extra-oral thermoelectric cooling device  227  are charged by using the plug charger into the electrical outlet or placing thermoelectric cooling device  227  onto a charging dock station which is connected to an outlet. A single use hygienic barrier sleeve is placed onto head section  202  of cooling device  205 . In an embodiment, where thermoelectric assembly  212  is within distal head end  203 , head section  202  is the placed onto the target tissue (i.e., the extra oral tissue of patient&#39;s skin) that needs to be cooled (i.e., anesthetized). Power button  228   a  is then turned on to start thermoelectric cooling device  227 . Optional vibration to provide is used at this point by pressing vibration switch  207 . Desired temperature is reached by using  216   a  (to increase the temperature) or by using  216   b  (to decrease the temperature). The operation time is set by using time/mode button  228   b . Timing indicator light  210  turns green to show desired time interval. Thermoelectric cooling device  205  operates at 45-second bursts and not continuously. Button  228   b  shows the power level; an orange light in warning indicator lights  209  indicates a low battery level and a red light indicates device  205  needs to be cooled down. 
     The current provided by the batteries in electronic assembly  217 , flows through device  205  and transferred to thermoelectric assembly  212  by wires  218   a  and  218   b , causing outer ceramic thermoelectric plate  223   b  to cool down to 4° C. (or other desired temperature as indicated on temperature display  208 ). The clinician places cold surface  225  of outer ceramic plate  223   b  on the skin surface of the target tissue causing the target tissue to become numb. The aforementioned method is repeated as needed for any site on the body of the patient. Power button  228   a  is pressed to turn extra oral thermoelectric cooling device  227  off. The hygienic sleeve is then removed and cooling device is wiped down with sanitizing solution before next patient. 
     Thus, specific embodiments of an intra-oral and extra-oral thermoelectric cooling devises and methods to employ such devices have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.