JP6100613B2

Systems and methods for creating an effect using microwave energy to specified tissue

Abstract

This record has no abstract on file.

JP6100613B2, drawing sheet 1 — Sheet 1 of 87

Term

6.7 yearsleft in the term

Expires 28 May 2033.

27 claims: 7 independent, 20 dependent

1
患者の汗腺を治療するための装置(153)であって、マイクロ波発生器(113)と、第1の面および第2の面を有する皮膚の折り畳み部(148)を形成するために、皮膚組織を把持するように構成されている把持機構(1231;1232;1233;1226)と、前記皮膚組織の少なくとも一部分に対して保護冷却を適用するように構成されている冷却要素(115)と、前記マイクロ波発生器に結合されている第1のマイクロ波アンテナおよび第2のマイクロ波アンテナ(154)であって、前記皮膚の折り畳み部(148)が形成されたときに、前記第1のマイクロ波アンテナ(154)は、前記皮膚の折り畳み部(148)の前記第1の面上に配置されており、前記第2のマイクロ波アンテナ(154)は、前記皮膚の折り畳み部の前記第2の面上に配置されており、前記第1のマイクロ波アンテナおよび前記第2のマイクロ波アンテナ(154)は、前記冷却要素(115)を介して前記皮膚組織にマイクロ波エネルギーを送達することにより、前記皮膚組織内の少なくとも1つの汗腺を少なくとも部分的に破壊または不能化するように構成されており、マイクロ波エネルギーは、前記皮膚組織に送達される唯一のエネルギーである、第1のマイクロ波アンテナおよび第2のマイクロ波アンテナ(154)とを含む、装置。
2
前記冷却要素(115)は、皮膚組織が前記把持機構(1231;1232;1233;1226)に配置されたときに、前記皮膚の折り畳み部(148)に近接して配置されるように適合されている、請求項1に記載の装置。
3
前記冷却要素(115)は、皮膚組織が前記把持機構(1231;1232;1233;1226)に配置されたときに、前記皮膚の折り畳み部(148)の前記第1の面に近接して配置されるように適合された第1の冷却要素(115)と、前記皮膚の折り畳み部(148)の前記第2の面に近接して配置されるように適合された第2の冷却要素(115)とを含む、請求項1に記載の装置。
4
前記把持機構(1231;1232;1233;1226)は、前記皮膚組織が前記把持機構(1231;1232;1233;1226)に配置されたときに、前記皮膚組織に対して吸引を提供するように構成されている吸引機構(1226)を含む、請求項1に記載の装置。
5
前記吸引機構(1226)は、前記皮膚組織を前記把持機構(1231;1232;1233;1226)に配置するために、前記皮膚組織に対して吸引を提供するように構成されている、請求項4に記載の装置。
6
汗の生成を低減するために皮膚組織を治療するための装置(153)であって、前記皮膚組織は、把持機構(1231;1232;1233;1226)を用いて形成される皮膚の折り畳み部(148)を含み、前記皮膚の折り畳み部(148)は、過剰な汗を生成する汗腺層を含み、前記装置(153)は、 1つ以上のマイクロ波発生器(113)に連結可能な少なくとも2つのマイクロ波アンテナ(154)であって、前記マイクロ波アンテナ(154)は、前記皮膚の折り畳み部(148)の各面から外側表皮層を横断してマイクロ波エネルギーを送達することによって、前記皮膚の折り畳み部(148)の中央における治療域(152)にマイクロ波エネルギーを送達することにより、前記皮膚の折り畳み部(148)内の少なくとも1つの汗腺を少なくとも部分的に破壊または不能化するように構成されており、マイクロ波エネルギーは、前記治療域(152)に送達される唯一のエネルギーである、少なくとも2つのマイクロ波アンテナ(154) を含む、装置(153)。
7
前記皮膚組織の少なくとも一部分に対して保護冷却を適用するための冷却要素(115)をさらに含む、請求項6に記載の装置。
8
第1のマイクロ波アンテナ(154)が、前記皮膚の折り畳み部(148)の第1の面上に配置されており、第2のマイクロ波アンテナ(154)が、前記皮膚の折り畳み部(148)の第2の面上に配置されている、請求項6または7に記載の装置。
9
前記冷却要素(115)は、前記皮膚の折り畳み部(148)に近接して配置されている、請求項6、7または8に記載の装置(153)。
10
前記冷却要素(115)は、前記皮膚の折り畳み部(148)の前記第1の面(150)に近接して配置された第1の冷却要素(115)と、前記皮膚の折り畳み部(148)の前記第2の面(150)に近接して配置された第2の冷却要素(115)とを含む、請求項6、7、8または9に記載の装置(153)。
11
前記装置は、前記皮膚の折り畳み部(148)を形成するための真空空洞(157)をさらに含む、請求項6、7、8、9または10に記載の装置。
12
前記皮膚組織は、腋窩部の領域に配置されている、請求項6、7、8、9、10または11に記載の装置(153)。
13
患者の皮膚組織を治療するためのシステムであって、前記皮膚組織は、汗腺層を含み、汗を生成し、前記システムは、第1の面および第2の面を含む皮膚の折り畳み部(148)を形成するために、前記皮膚組織を把持するための手段(1231;1232;1233;1226)であって、折り畳まれたときに、前記第1の面に対応する汗腺層は、前記第2の面に対応する汗腺層に近接して隣り合い、その結果、前記層が治療域(152)を含む、手段と、前記皮膚組織の少なくとも一部分に対して保護冷却を適用するための冷却要素(115)と、前記皮膚の折り畳み部(148)の前記第1の面および前記第2の面上に配置されるように構成され、かつ、前記冷却要素(115)を介して前記治療域(152)にマイクロ波エネルギーを送達することにより、治療効果をもたらすように構成されているマイクロ波アンテナ(154)であって、前記治療効果は、前記皮膚組織からの発汗量を低減し、マイクロ波エネルギーは、前記治療域(152)に送達される唯一のエネルギーである、マイクロ波アンテナ(154)とを含む、システム。
14
前記皮膚組織は、腋窩部の少なくとも一部分を含む、請求項13に記載のシステム。
15
前記皮膚組織の少なくとも一部分に対して保護冷却を適用するための前記冷却要素(115)は、前記皮膚の折り畳み部(148)に近接して配置されるように構成されている、請求項14に記載のシステム。
16
前記冷却要素(115)は、第1の冷却要素(115)が、前記皮膚の折り畳み部(148)の前記第1の面に近接して配置され、第2の冷却要素(115)が、前記皮膚の折り畳み部(148)の前記第2の面に近接して配置されることにより、前記皮膚の折り畳み部に近接して配置されるように構成されている、請求項15に記載のシステム。
17
前記皮膚の折り畳み部(148)を形成するために、前記皮膚組織を把持するための手段(1231;1232;1233;1226)は、前記皮膚組織に対して吸引を提供するための手段(1226)をさらに含む、請求項13に記載のシステム。
18
前記皮膚組織に対して吸引を提供するための手段(1226)は、治療中に前記皮膚組織に対する吸引を維持するための手段をさらに含む、請求項17に記載のシステム。
19
前記皮膚組織は、腋窩部の領域に配置されている、請求項18に記載のシステム。
20
汗の低減のために皮膚組織を治療するための装置を配置するためのシステムであって、前記皮膚組織は、汗を生成する汗腺層を含み、前記システムは、皮膚の折り畳み部を形成するための手段(1231;1232;1233;1226)であって、前記皮膚の折り畳み部(148)は、第1の面および第2の面を含み、折り畳まれたときに、前記第1の面に対応する汗腺層は、前記第2の面に対応する汗腺層に近接して隣り合い、その結果、前記層が治療域(152)を含む、手段と、前記皮膚の折り畳み部(148)の前記第1の面および前記第2の面上に配置されるように構成されたマイクロ波アンテナ(154)であって、前記皮膚の折り畳み部の各面から外側表皮層を横断してマイクロ波エネルギーを送達することにより、前記皮膚の折り畳み部(148)の中央における治療域(152)への前記マイクロ波アンテナ(154)を介するマイクロ波エネルギーの送達を可能にし、審美的治療効果をもたらすためのマイクロ波アンテナ(154)とを含み、マイクロ波エネルギーは、前記治療域(152)に送達される唯一のエネルギーであり、前記治療効果は、前記皮膚組織からの発汗量を低減することにより、外観を改善する、システム。
21
前記皮膚組織の少なくとも一部分に対して保護冷却(115)を適用するための手段をさらに含む、請求項20に記載のシステム。
22
前記皮膚組織の少なくとも一部分に対して保護冷却(115)を適用するための手段は、前記皮膚の折り畳み部(148)に近接して配置されるように構成された冷却要素(115)を含む、請求項21に記載のシステム。
23
前記冷却要素(115)は、第1の冷却要素(115)が、前記皮膚の折り畳み部の前記第1の面に近接して配置され、第2の冷却要素(115)が、前記皮膚の折り畳み部の前記第2の面に近接して配置されることにより、前記皮膚の折り畳み部(148)に近接して配置されるように構成されている、請求項22に記載のシステム。
24
前記皮膚の折り畳み部(148)を形成するための手段(1231;1232;1233;1226)は、前記皮膚組織に対する吸引により、前記皮膚の折り畳み部(148)を形成し、かつ、治療中に前記皮膚組織の吸引を維持するように構成されている、請求項20~23のいずれか一項に記載のシステム。
25
前記皮膚組織は、腋窩部の領域に配置されている、請求項20~24のいずれか一項に記載のシステム。
26
前記装置は、前記皮膚組織からの発汗量を低減することにより、発汗の外観を改善するように構成されている、請求項1~12のいずれか一項に記載の装置。
27
前記マイクロ波アンテナ(154)は、汗腺の選択的加熱が可能となるように、配置され、かつ、マイクロ波エネルギーを送達するように構成されている、請求項13~25のいずれか一項に記載のシステム。

Independent claims27

209 paragraphs, as filed

0001(Cross-reference of related applications) This application applies to US Provisional Patent Application No. 60 / 912,899 (name "Methods and MFP for Reducing Sweat Production", filed April 19, 2007), US Provisional Patent Application No. 61 / 013,274 (name "Methods, Delivery and Systems"). for Non-Invasive Delivery of Microwave Therapy ", filed December 12, 2007), and US Provisional Patent Application No. 61 / 045,937 (named" Systems and Methods for Creating an Effect Using Microwave Energy in Specified Tissue ", April 2008). Claims the benefit of the priority of Article 119 (e) of the US Patent Act (filed on 17th March). All disclosures of all these priority applications are incorporated herein by reference in their entirety.

0002(Field of invention) The present application relates to methods and devices for reducing sweat production. In particular, the present application relates to methods and devices for reducing sweat production through removal, disabling, and disabling of apocrine and eccrine sweat glands in the dermis and subcutaneous tissue.

0003(Field of invention) It is known that energy therapy can be applied to tissues throughout the body to achieve multiple therapeutic and / or aesthetic outcomes. There remains a continuing need to improve the effectiveness of these energy therapies and provide beneficial pathological changes with minimal adverse side effects or discomfort.

(Outline of treatment) Sweating is a normal thermoregulatory process for humans as well as a normal physiological response to psychological stress and circular stimuli. For most people, sweating is only a minor aesthetic discomfort. However, for others, sweating is excessive and abnormal, which can result in socially unconventional conditions. Some embodiments of the present invention relate to methods for reducing sweat production through removal, incapacity, incapacity, and destruction of sweat glands in human subcutaneous tissue.The present invention provides, for example,:(Item 1) A device that treats a patient's sweat glands With an energy generator With an energy delivery device configured to be placed in close proximity to the patient's skin tissue The energy delivery device is coupled to the energy generator, and the energy delivery device is sufficient to at least partially destroy or incapacitate at least one sweat gland in the target tissue within the skin tissue. A device configured to deliver energy to the target tissue.(Item 2) The device of item 1, wherein the energy delivery device is configured to be inserted into the target tissue.(Item 3) The energy delivery device comprises at least one energy delivery element selected from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, low temperature probes, and combinations thereof. Device.(Item 4) The device of item 1, further comprising a cooling element configured to be placed in close proximity to the patient's non-target tissue.(Item 5) The device of item 1, further comprising a suction device configured to be placed in close proximity to the skin tissue of the patient.(Item 6) A device that treats a patient's target tissue An intervening device comprising at least one needle configured to be inserted in close proximity to the patient's target tissue. With a light energy source configured to transmit light energy to the intervening device The needle is configured to receive the light energy transmitted by the light energy source.(Item 7) The device according to item 6, wherein the needle comprises a chromophore configured to absorb the light energy received from the light energy source.(Item 8) The device according to item 7, wherein the chromophore generates heat energy from the light energy absorbed from the light energy source. (Item 9) The device according to item 8, wherein the heat energy from the chromophore produces a therapeutic effect on the target tissue.(Item 10) 9. The apparatus of item 9, wherein the therapeutic effect on the target tissue comprises heating the target tissue.(Item 11) 9. The apparatus of item 9, wherein the therapeutic effect on the target tissue comprises at least partially excising the target tissue.(Item 12) Item 9. The therapeutic effect on the target tissue comprises at least partially disabling at least one target structure selected from the group consisting of sweat glands, hair follicles, sebaceous glands, collagen, and fat. Equipment.(Item 13) 9. The device of item 9, wherein the intervening device further comprises a microneedle patch with an optically neutral backing.(Item 14) A way to treat a patient To identify a patient with symptoms of excessive sweating, the patient desires to reduce sweating on at least a portion of the patient's body. Placing an energy delivery device in close proximity to the patient's skin tissue Delivering sufficient energy to the patient's sweat glands to stop sweat production by at least partially disabling or destroying the sweat glands. Including methods.(Item 15) Placing an energy delivery device further selects an energy delivery element from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, low temperature probes, and combinations thereof, the above skin of the patient. 14. The method of item 14, comprising placing in close proximity to the tissue.(Item 16) The method of item 14, wherein placing the energy delivery device further comprises inserting the energy delivery device into the skin tissue.(Item 17) Inserting the energy delivery device into the skin tissue further includes inserting the energy delivery device into the skin tissue to a depth ranging from about 1 mm to about 8 mm below the surface of the skin. , Item 16.(Item 18) Delivering energy to the patient's sweat glands further consists of electromagnetic, X-ray, radio frequency, microwave, ultrasonic, near-infrared, infrared, ultrashort pulsed light, visible light, and lasers, and combinations thereof. 15. The method of item 15, comprising delivering energy selected from the group to the sweat glands.(Item 19) The method of item 18, wherein delivering energy to the sweat glands further comprises heating the sweat glands.(Item 20) 19. The method of item 19, wherein heating the sweat glands further comprises removing the sweat glands at least partially.(Item 21) 14. The method of item 14, further comprising providing protective cooling to the skin tissue.(Item 22) 21. The method of item 21, wherein providing protective cooling to the skin tissue further comprises placing a cooling element in close proximity to the skin tissue.(Item 23) The method of item 14, further comprising administering to the patient an agent selected from the group consisting of anesthetics, steroids, and antibiotics.(Item 24) 23. The method of item 23, wherein administering the drug to the patient further comprises administering the drug orally, topically, or via injection.(Item 25) 14. The method of item 14, further comprising visualizing the sweat glands using medical imaging.(Item 26) 14. The method of item 14, further comprising monitoring the diagnostic parameters of the skin tissue.(Item 27) 26. The method of item 26, wherein the diagnostic parameters are selected from the group consisting of impedance, temperature, reflected light, and reflected power.(Item 28) 14. The method of item 14, wherein delivering energy to the sweat glands of the patient further comprises modulating the energy delivery according to the monitored diagnostic parameters.(Item 29) The method of item 14, further comprising reducing sweating achieved in the patient or quantifying the treated portion of the patient's body.(Item 30) 14. The method of item 14, wherein at least a portion of the patient's body comprises at least a portion of the patient's axilla.(Item 31) 14. The method of item 14, further comprising raising the skin tissue away from the underlying tissue prior to delivering energy to the sweat glands.(Item 32) Inserting the energy delivery device into the skin tissue further comprises inserting into the skin tissue an intervening device selected from the group consisting of needles, stylets, catheters, probes, and microneedles. The method described in 16.(Item 33) A way to treat patients for the symptoms of hyperhidrosis, Identifying a skin tissue area on a patient with a sweat gland layer, which produces excess sweat associated with the hyperhidrosis. Gripping the skin tissue region so as to form a fold of the skin comprising a first aspect and a second aspect, the sweat gland layer corresponding to the first aspect is said to be said. By adjoining the sweat gland layer corresponding to the second aspect, the layer comprises a therapeutic area. Delivering energy to the therapeutic area to produce a therapeutic effect, the therapeutic effect reducing the amount of sweating from the skin tissue area. Including methods.(Item 34) 33. The method of item 33, further comprising applying protective cooling to at least a portion of the skin tissue area.(Item 35) 34. The method of item 34, wherein applying protective cooling to at least a portion of the skin tissue area further comprises placing a cooling element in close proximity to the skin fold.(Item 36) Placing the cooling element in close proximity to the skin fold further comprises a first cooling element in close proximity to the first aspect of the skin fold and the second in the skin fold. 35. The method of item 35, comprising placing a second cooling element in close proximity to the sides.(Item 37) 33. The method of item 33, wherein grasping the skin tissue area to form a fold of the skin further comprises providing suction to the skin tissue area.(Item 38) 37. The method of item 37, wherein providing suction to the skin tissue area further comprises maintaining suction to the skin tissue area during treatment.(Item 39) A way to reduce patient sweating By raising the skin tissue of the patient, the skin tissue comprises a target tissue containing at least one sweat gland. Delivering energy to the target tissue, which at least partially disables or destroys the at least one sweat gland so as to reduce sweating from the patient's skin tissue. That and Including methods.(Item 40) 39. The method of item 39, wherein delivering energy to the target tissue further comprises placing an energy delivery device in close proximity to the skin tissue of the patient.(Item 41) Placing an energy delivery device further provides an energy delivery element selected from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, low temperature probes, and combinations thereof. 40. The method of item 40, comprising placing in close proximity to skin tissue.(Item 42) 27. The method of item 27, wherein placing the energy delivery device further comprises inserting the energy delivery device into the skin tissue.(Item 43) 42. The method of item 42, wherein inserting the energy delivery device into the skin tissue further comprises placing the insertion element energy delivery element in close proximity to the target tissue.(Item 44) 39. The method of item 39, wherein the energy delivery element is selected from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, and combinations thereof.(Item 45) 26. The method of item 26, wherein raising the skin tissue further comprises imparting aspiration to the skin tissue.(Item 46) 39. The method of item 39, further comprising providing protective cooling to the skin tissue.(Item 47) 46. The method of item 46, wherein providing protective cooling to the skin tissue further comprises placing a cooling element in close proximity to the skin tissue.(Item 48) Delivering energy to the target tissue further comprises delivering energy to a first portion of the target tissue the first time and to a second portion of the target tissue a second time. The method described in item 39.(Item 49) The method according to item 48, wherein the first and second times are separated by a predetermined period.(Item 50) The method according to item 49, wherein the predetermined period is selected from the group consisting of 1 to 7 days, 1 to 4 weeks, and 1 to 4 months.

0005These and other features, aspects and advantages of the various devices, systems and methods presented herein are illustrated, but not intended to be limited to, such devices, systems and methods. This will be described with reference to the drawings of a certain embodiment. It should be understood that the accompanying drawings are for purposes of illustrating the concepts of embodiments discussed herein and may not be to a certain scale.<figref num="1">FIG. 1 shows a cross-sectional view of the skin, its internal structure, and surrounding tissues.</figref><figref num="2">FIG. 2 shows a cross-sectional view of a target tissue having a heat-treated area according to one embodiment.</figref><figref num="3">FIG. 3 shows a device with an energy applicator according to one embodiment.</figref><figref num="4">FIG. 4 shows an isometric view of a non-invasive energy delivery device with a plurality of microwave antennas electrically connected to a microwave generator according to one embodiment.</figref><figref num="5">FIG. 5 shows a cross-sectional side view of the non-invasive energy delivery device of FIG. 4, which delivers energy into the skin.</figref><figref num="6A">FIG. 6A shows a monopole antenna according to one embodiment.</figref><figref num="6B">FIG. 6B shows a dipole antenna according to one embodiment.</figref><figref num="6C">FIG. 6C shows a spiral antenna according to one embodiment.</figref><figref num="6D">FIG. 6D shows a loop antenna according to one embodiment.</figref><figref num="6E">FIG. 6E shows a monopole antenna with a conductive shield or sleeve according to one embodiment.</figref><figref num="6F">FIG. 6F shows an antenna with a molded outer conductor according to one embodiment.</figref><figref num="6G">FIG. 6G shows an antenna with a molded outer conductor according to one embodiment.</figref><figref num="7A">FIG. 7A shows a cross-sectional view of an antenna having an internal conductor arranged within a coaxial cable according to one embodiment.</figref><figref num="7B">FIG. 7B shows a coiled antenna with a coiled conductor element made entirely of coaxial cable, according to one embodiment.</figref><figref num="7C">FIG. 7C shows a coiled antenna with a coiled conductor element formed from an internal conductor, according to one embodiment.</figref><figref num="8">FIG. 8 shows a needle that injects fluid near the base of the sweat glands and target tissue, according to one embodiment.</figref><figref num="9">FIG. 9 shows a number of possible configurations of bipolar electrodes for the desired therapeutic area.</figref><figref num="10">FIG. 10 shows an RF delivery device with one or more energy delivery elements, comprising an electrode tip needle, a microneedle, or a stylet for insertion into the skin, according to one embodiment.</figref><figref num="11">FIG. 11 shows, according to one embodiment, an energy delivery device comprising a needle configured for percutaneous insertion.</figref><figref num="12A">FIG. 12A shows a cryogenic system, according to one embodiment, configured to have an intervening element with at least two concentric tubes.</figref><figref num="12B">FIG. 12B shows a cold system configured to have an intervening element configured with a tubular coil that resides inside the element.</figref><figref num="12C">FIG. 12C shows a cold system configured to have an intervening element configured with a tubular coil that is partially inside and partly outside the element.</figref><figref num="12D">Figure 12D shows a cryogenic system configured to have an inner and outer part such that nitrous oxide gas exits the distal part of the inner tube and absorbs thermal energy from the distal part of the outer tube. Shown.</figref><figref num="12E">FIG. 12E shows an injection of a cryoprotectant according to one embodiment.</figref><figref num="12F">FIG. 12F shows a protected non-target tissue area between the cold heat source on the skin surface and the cryotreated area of the target tissue according to one embodiment.</figref><figref num="13">FIG. 13 shows a layer of colored bioreabsorbable microspheres deposited in or around the target tissue according to one embodiment.</figref><figref num="14">FIG. 14 shows a carrier solution, according to one embodiment, introduced by a hollow needle into the planar junction between the dermis layer and the subcutaneous layer.</figref><figref num="15">FIG. 15 shows needles consisting of at least one chromophore on their tips, according to one embodiment.</figref><figref num="16">FIG. 16 shows a microneedle configuration with an undetectable chromophore tip according to one embodiment.</figref><figref num="17">FIG. 17 shows locally applied aluminum ion particles moving down the sweat gland canal.</figref><figref num="18A">FIG. 18A shows a microneedle patch according to one embodiment.</figref><figref num="18B">FIG. 18B shows an ultrasonic transducer that emits waves as part of ultrasonic therapy according to one embodiment.</figref><figref num="18C">FIG. 18C shows a planar ultrasonic transducer that emits waves as part of ultrasonic therapy according to one embodiment.</figref><figref num="19">FIG. 19 shows the thermal incapacity of sweat glands using a controlled chemical reaction according to one embodiment.</figref><figref num="20">FIG. 20A shows the sweat duct. FIG. 20B shows the sweat tube of FIG. 20A with an insulating layer according to one embodiment. FIG. 20C shows the sweat duct of FIG. 20B having an insulating layer and being treated with electrical energy, according to one embodiment.</figref><figref num="21A">FIG. 21A shows a probe with a fixed position retractable blade inserted percutaneously under the sweat glands, according to one embodiment.</figref><figref num="21B">FIG. 21B shows the probe of FIG. 21A with a retractable blade in a retracted position, according to one embodiment.</figref><figref num="21C">FIG. 21C shows the probe of FIG. 21B, according to one embodiment, having a retractable blade in a forward position from its retracted position so that the sweat glands are sheared.</figref><figref num="22A">FIG. 22A shows, according to one embodiment, a wire device having an actuator for bending a wire into an extended outer shape.</figref><figref num="22B">FIG. 22B shows an actuator having an outer element and an inner element according to one embodiment.</figref><figref num="23">FIG. 23 shows a planar cutting device with a wind turbine type cutter according to one embodiment.</figref><figref num="24">FIG. 24 shows, according to one embodiment, a wire digging into a target tissue through two insertion points in the skin.</figref><figref num="25">FIG. 25 shows a wire, according to one embodiment, configured to be inserted into the target tissue and exiting the target tissue through a single insertion point.</figref><figref num="26A">FIG. 26A shows a digging tool with an actuator according to one embodiment.</figref><figref num="26B">FIG. 26B shows a digging tool with an actuator according to another embodiment.</figref><figref num="27">FIG. 27 shows a sweat gland canal filled with a photodynamic adhesive according to one embodiment.</figref><figref num="28">FIG. 28 shows a biocompatible scaffold introduced into the sweat duct according to one embodiment.</figref><figref num="29">FIG. 29 shows a piston used to deliver pressurized gas to the sweat glands, according to one embodiment.</figref><figref num="30A">FIG. 30A shows a sweat gland with fluid according to one embodiment.</figref><figref num="30B">FIG. 30B shows the sweat glands of FIG. 30A, which were ruptured after the liquid had frozen.</figref><figref num="31">FIG. 31 shows a device for causing pressure-induced necrosis of sweat glands according to one embodiment.</figref><figref num="32">FIG. 32 shows, according to one embodiment, a target tissue having microbubbles and microspheres subject to rupture by an ultrasonic transducer.</figref><figref num="33">FIG. 33 shows a cross-sectional view of a target tissue having a heat treatment area according to one embodiment.</figref><figref num="34A">FIG. 34A shows an isometric view of a non-invasive energy delivery device with multiple microwave antennas electrically connected to a microwave generator, according to one embodiment.</figref><figref num="34B">FIG. 34B shows a schematic diagram of an energy source and a cooling source located remote from the energy applicator according to one embodiment.</figref><figref num="35A">FIG. 35A shows a needle, according to one embodiment, configured with a proximal region with a cooling element and a distal end with an electrode tip.</figref><figref num="35B">FIG. 35B shows an energy delivery device element, comprising a metal electrode, an inner tube, and an outer peripheral surface, according to one embodiment.</figref><figref num="36">FIG. 36 shows an energy delivery device with a bipolar pair of needle tip electrodes according to one embodiment.</figref><figref num="37A">FIG. 37 shows a cooling electrode with a heat sink located between two pairs of bipolar needle electrodes, according to one embodiment.</figref><figref num="37B">FIG. 37B shows the cooling electrodes in alternating order with the unipolar electrodes according to one embodiment.</figref><figref num="38">FIG. 38 shows a side view of a vacuum that pulls and supports the skin according to one embodiment.</figref><figref num="39">FIG. 39 shows a needle with an energy delivery element according to one embodiment.</figref><figref num="40">FIG. 40 shows a side view of a vacuum in which an electrode-embedded skin is pulled and supported according to one embodiment.</figref><figref num="41">FIG. 41 shows an example of a typical skin fold.</figref><figref num="42">FIG. 42 shows a fold of skin being treated by an energy delivery device with two energy delivery elements, according to one embodiment.</figref><figref num="43A">FIG. 43A shows, according to one embodiment, a minimally invasive RF delivery device comprising one or more needles for insertion into a skin fold.</figref><figref num="43B">FIG. 43B shows a minimally invasive microwave delivery device, according to one embodiment, comprising one or more microwave antennas for insertion into a skin fold.</figref><figref num="43C">FIG. 43C shows a minimally invasive hypothermic therapy device comprising one or more needles, catheters, stylets, cannulas, or catheters, according to one embodiment.</figref><figref num="44">FIG. 44 shows an energy delivery device according to one embodiment that is inserted through the edge of the skin fold and placed along the vertical axis of the fold.</figref><figref num="45">FIG. 45 shows an energy delivery device according to one embodiment that is inserted at the top of the skin fold.</figref><figref num="46A">FIG. 46A shows an array of unipolar electrode needles used to deliver treatment along the longitudinal length of the skin fold, according to one embodiment.</figref><figref num="46B">FIG. 46B shows an array of unipolar electrode needles used to deliver treatment along the longitudinal length of the skin fold, according to another embodiment.</figref><figref num="47A">FIG. 47A shows, according to one embodiment, an energy delivery device inserted at the top of the skin fold after the needle and blunt dissociation electrode have been inserted.</figref><figref num="47B">FIG. 47B shows an energy delivery device inserted at the top of the skin fold after the needle and blunt dissociation electrode have been inserted, according to an alternative embodiment.</figref><figref num="48">FIG. 48 shows one or more paddle elements connected to vibration sources detachably connected to each outside of the skin fold according to one embodiment.</figref><figref num="49">FIG. 49 shows a skin fold treated by two ultrasonic transducers arranged on two sides of the skin fold according to one embodiment.</figref><figref num="50A">FIG. 50A shows an ultrasound delivery device, according to one embodiment, used to deliver ultrasound therapy on one side of a fold of skin.</figref><figref num="50B">FIG. 50B shows the light energy radiated from one energy source to the skin folds according to one embodiment.</figref><figref num="51">FIG. 51 shows a perspective view of a suction electrode comprising a housing, a tissue chamber, a vacuum port, and an electrode according to one embodiment.</figref><figref num="52A">FIG. 52A shows a perspective view of a clamp used to create and support a skin fold according to one embodiment.</figref><figref num="52B">FIG. 52B shows a side view of a clamp used to create and support a skin fold according to a second embodiment.</figref><figref num="52C">FIG. 52C shows a side view of a clamp used to create and support a skin fold according to a third embodiment.</figref><figref num="53">FIG. 53 shows an array of electrodes configured to deliver energy, according to one embodiment.</figref><figref num="54">FIG. 54 shows an embodiment of a representative grid showing a target treatment site "A" and a target treatment site "B" that can be used over the skin area to identify a particular treatment area.</figref><figref num="55">FIGS. 55A-E show various patterns illustrating specific therapeutic and non-therapeutic areas that can be used over the skin area.</figref><figref num="56">FIG. 56 shows three templates used in stepwise treatment, each template configured to allow treatment to different parts of the overall treatment area, according to one embodiment.</figref><figref num="57">FIG. 57 shows a single template pattern represented by different chromophores, corresponding to different stages of treatment, according to one embodiment.</figref>

0006Hyperhidrosis is a clinically diagnosed disorder with excessive secretion of sweat from the sweat glands. Excessive sweating, which is thought to be due to overactivity of the sympathetic nervous system, usually occurs in the palms, soles, and axillae. Hyperhidrosis of the palm is a symptom of excessive sweating of the hands. This symptom is often manifested by a cold, moist handshake. Plantar hyperhidrosis is a symptom of excessive sweating of the feet. This symptom can cause blisters and fungal infections. Axillary hyperhidrosis is a symptom of excessive underarm sweating. Such excessive sweating is not only socially unconventional, but can even cause contamination and putrefaction of clothing.

0007The sweat glands in the body consist of apocrine and eccrine sweat glands. Superficially located in the dermis layer of the skin, the eccrine sweat glands are located on one side of the body so that they can secrete sweat and regulate body heat and temperature. Located within the subcutaneous tissue and the boundary on the junction between the subcutaneous tissue layer and the dermis layer, the apocrine sweat glands secrete oily, milky, protein-rich products into the hair follicles. Bacterial digestion of apocrine sweat is largely involved in axillary odor or hyperhidrosis or (ie, body odor), which can be most prominent in the foot and axillary areas.

0008There are various treatments used to treat hyperhidrosis. For example, chemical antiperspirants and deodorants are commonly used as a matter of personal hygiene. Antiperspirants are aluminum-based salts that mechanically block the sweat gland ducts, thereby preventing sweat from reaching the surface of the skin. Body odor inhibitors change the pH of the skin surface, thereby minimizing the presence of odor-inducing bacteria. These products are a suboptimal solution for cases of excessive sweating, as the effects of both of these products are temporary and can be irritating to the skin in some users.

0009In addition to antiperspirants and antiperspirants, other topical formulations have been used to treat hyperhidrosis. For example, glutaraldehyde and tannic acid have been used in the treatment of hyperhidrosis of the soles and palms. However, these treatments are generally unsupported because they can cause ugly browning of the skin.

0010Anticholinergic agents have also been applied both locally and systemically to treat hyperhidrosis. These agents block sympathetic nerve stimulation of the eccrine sweat glands by inhibiting the action of acetylcholine at nerve synapses. The use of these agents is limited due to the systemic side effects they can cause, including dry mouth, urinary retention, constipation, and visual impairment such as mydriasis and cycloplegia. Also, topical anticholinergic agents may be difficult to absorb into the skin in sufficient amounts to affect cholinergic nerve endings.

0011Some patients with hyperhidrosis have used surgical treatments such as sweat gland resection and thoracic sympathectomy. For example, Takasu's US Pat. No. 5,190,518, which is incorporated herein by reference in its entirety, discloses an ultrasonic surgical device for disabling and removing sweat glands. These treatments may provide a longer period of relief for hyperhidrosis. However, these treatments are rarely indicated due to their invasiveness, adverse effects, and cost. For example, surgery can cause contractures of the skin, muscles, and other surrounding tissues. Sympathectomy can result in complications, including infections, pneumothorax, Homer's syndrome, and compensatory hyperhidrosis of the torso, back, and thighs.

0012In recent years, Clostridium botulinum type A neurotoxin (eg, BOTOX®) has proven effective in treating hyperhidrosis in some patients. BOTOX is commonly used by dermatologists to paralyze the nerves at the nerve gland junction between the autonomic nerves and the sweat glands. When neural connections are disabled, acetylcholine is unable to reach the eccrine sweat glands, thereby disabling the overactive sympathetic nervous system components of hyperhidrotic patients. However, this treatment is not without its drawbacks. Clostridium botulinum toxin is one of the most deadly substances on the planet, and as a result, injecting it into the patient's body is dangerous. In addition, injection of Clostridium botulinum toxin has no clinical effect on body odor caused by secretion from the apocrine sweat glands, as the apocrine sweat glands are innervated by adrenergic nerves that are not blocked by Clostridium botulinum toxin. Treatment of Clostridium botulinum toxin also requires multiple painful injections with a needle. Moreover, the results of this treatment last only a few months, thereby requiring repetitive, expensive and painful treatment.

0013Given the shortcomings of the aforementioned approach, minimally invasive, convenient, effective and sustained treatment with few side effects may be the preferred alternative for treating hyperhidrosis.

0014(Discussion of biological structure) FIG. 1 shows an isometric view of a cross section of the skin, its internal structure, and surrounding tissues. The skin comprises three major layers: the epidermis 102, the dermis 101, and the hypodermis 100. Epidermis 102 is the thin epithelial surface of the skin. Epidermis 102 consists of several accessory layers, including the stratum corneum, the keratin-producing cell layer, and the basal layer. Epidermis 102 also contains melanin-producing melanocytes involved in skin pigmentation. The thickness of the epidermis 102 ranges from 0.05 mm to 1.5 mm depending on the location of the skin on the body.

0015The dermis 101 is the middle layer of the skin and consists of blood vessels, lymph vessels, hair follicles, sebaceous glands, eccrine sweat glands, and sometimes apocrine sweat glands. The dermis 101 is bound by fibroblasts, which may be present as collagen proteins, elastic tissue, and / or reticular fibers. The 101st layer of the dermis also contains nerve receptors corresponding to pain and touch. The thickness of the dermis 101 varies depending on the location of the skin. The thickness of the dermis 101 can range from 0.3 mm in the eyelids to 3.0 mm in the back.

0016Subcutaneous tissue 100 is a layer of fat and connective tissue that houses larger blood vessels and nerves. While apocrine sweat glands may be located in the dermis layer of the skin, the presence of these sweat glands in the subcutaneous tissue is more common. This layer 100 provides a thermal barrier that helps store body heat and an additional cushion that protects the organs from traumatic damage. Below the subcutaneous layer lies the muscle support structure of the body.

0017Eccrine sweat glands are distributed throughout the body surface with densities ranging from 50 sweat glands per square centimeter to 200 sweat glands per square centimeter. These sweat glands are most densely located on the palms, soles, forehead, and armpits. The eccrine sweat glands have three different parts: (1) the inner part of the epidermis, (2) the inner dermal canal (coiled and straight), and (3) the secretory part (coiled gland). The coiled glands are located in the deep dermis or at the boundary between the dermis 101 and the subcutaneous layer 100. The intradermal tube extends upward from the coiled gland through the dermis 101, first as a coiled tube and then as a straight tube. The straight tube ends when it enters the epidermis 102, then spirals as it continues through the epidermis 102 and opens directly on the surface of the skin.

0018Human eclin sweat consists of water, sodium, potassium lactate, urea, ammonia, serine, ornithine, citrulline, aspartic acid, heavy metals, organic compounds, and proteolytic enzymes. In general, the concentration of sodium in eccrine sweat varies from 35 to 65 mmol / l.

0019Eccrine sweat glands are controlled by cholinergic sympathetic nerves, which are controlled by the hypothalamus. The hypothalamus directly senses core temperature and also obtains inputs from temperature receptors in the skin. Eccrine sweat production is initiated by the hypothalamus through the production of postganglionic fibers of acetylcholine.

0020Apocrine sweat glands are mainly located under the armpits and around the anogenital genital area. These sweat glands are (1) coiled glands in the deeper part of the dermis or at the junction of the dermis and subcutaneous fat, and (2) straight across the dermis into the isthmus (top) of the hair follicle. It consists of a tube. The lumen of the coiled portion of the apocrine sweat gland is about 10 times the diameter of its eccrine counterpart. The straight tube extends from the coiled gland to the isthmus of the hair follicle and is virtually identical in appearance to the eccrine straight tube.

0021Emotional stressors stimulate adrenergic sympathetic nerves, which initiate the release of viscous fatty sweat from the apocrine sweat glands. The amount of sweat produced by these sweat glands is significantly less than the amount of sweat produced by the eccrine sweat glands. Although initially odorless, apocrine sweat develops an odor when it comes into contact with the surface of the skin, and surface bacteria break down organic compounds in the sweat to produce an odor.

0022Another type of sweat-producing gland, the apoeclin sweat gland, may be found in the axilla (under the axilla). These complex sweat glands are most commonly found in patients with hyperhidrosis and are thought to play a role in axillary hyperhidrosis. Their secretory parts have both a small diameter part similar to the eccrine sweat glands and a large diameter part similar to the apocrine sweat glands. These sweat glands are similar to eccrine sweat glands in that they respond primarily to cholinergic stimuli and their tubes are long and open directly on the surface of the skin. However, the apoeccrine sweat glands secrete almost 10 times more than the eccrine sweat glands. Other non-limiting examples of tissue structures and medical conditions that may be treated using the systems, methods, and devices of some embodiments disclosed herein are referred to, for example, in their entirety. It is described on pages 1-10 of US Provisional Application No. 61 / 013,274, incorporated by.

0023(Overview of method and equipment) Embodiments of the present application relate to methods and devices for reducing sweat production through the removal, disabling, disabling, or destruction of apocrine and eccrine sweat glands in the dermis and subcutaneous tissue. It is envisioned that many mechanisms and modalities can be implemented individually or in combination to achieve reduced patient sweat production. It is considered that the treatments disclosed herein can be applied to any part of the body that is involved in or contributes to the production, secretion, and / or presence of sweat.

0024One approach to reducing sweat production is to first identify the target area of the target patient. More preferably, a particular sweat gland, or region containing such a sweat gland, may be identified, and the sweat gland and / or surrounding tissue can be treated with energy. This energy can take many forms (eg, electromagnetic, microwave, radio frequency, laser, infrared, ultrasonic, etc.) and in any number of ways (eg, locally, minimally invasively, etc.) ) Can be delivered. In addition, the devices employed in energy therapy may include one or more electrodes, antennas, oscillators, needles, probes, catheters, microneedles, and stylets. Some of the other heat treatments that can be employed include induction heating, resistance heating, hyperthermic chemistry, and / or hypothermia.

0025Protective treatments can be employed in combination with the heat treatments disclosed herein to prevent damage or pain to non-target tissues. In one embodiment, thermal protection therapy may be used. For example, surface cooling can be applied to protect each part of the epidermal and dermis layers of the skin while a deeper area of skin tissue is being heated via energy delivery. Various types of active and passive cooling can be configured to provide thermal protection to this non-target tissue.

0026There are also a number of mechanical approaches to reducing sweat production. For example, sweat glands can be surgically excised, sheared using various wires and / or blades, sealed and closed, ruptured under pressure, and disabled via acoustic cavitation.

0027Reduction of sweat production may be facilitated by administering many of the treatments disclosed herein in one or more spatial configurations or skin shapes. For example, the treatment can be directed perpendicular to the skin surface, parallel to the skin surface, or at some angle in between. In addition, treatment can be delivered to skin with a flat, planar construction, elevated orientation, or a folded shape.

0028Reduction of sweat production may also be facilitated by administering treatment over multiple stages and in a patterned arrangement. This approach can enhance the body's healing response and help with faster recovery with few complications. Various templates have been disclosed to assist in the administration of stepwise and patterned treatments.

0029With reference to the drawings disclosed herein, details are provided as an example and for the purposes of an exemplary discussion of certain embodiments. Not all structural details may be presented in detail in this regard. Therefore, it should be understood that the present invention is not limited to the details of the structure and arrangement of the components as described in the description or illustration provided herein. In addition, it should be understood that the terms used herein are for illustration purposes only and should not be considered limiting.

0030FIG. 2 shows a cross-sectional view of the skin, its three main layers, and its internal structure. In one embodiment, the treatment is concentrated within the area of dermis 101 and 100 subcutaneous tissues (lower skin) (eg, "target tissue" 105) where the eccrine and apocrine sweat glands are present, while within the epidermis 102 and dermis 101. Minimal damage to the tissues above the sweat glands (eg, "superficial non-target tissue" 103) and other tissue structures within the subcutaneous layer 100 (eg, "deep non-target tissue" 104) is desirable. .. Depending on the area of the body, the target tissue 105 area may start somewhere about 0.5 mm to about 4 mm below the surface of the skin and end somewhere about 1 mm to about 10 mm below the surface of the skin. Depending on the area of the body, the 103 areas of superficial non-target tissue may start at the surface of the skin and end somewhere between about 0.5 mm and about 4 mm below the surface of the skin. Depending on the area of the body, the 104 areas of deep non-target tissue may start somewhere between about 1 mm and about 10 mm below the surface of the skin.

0031In the axillary region (under the axilla), the target tissue area may start somewhere about 1 mm to about 3 mm below the surface of the skin and end somewhere about 3 mm to about 8 mm below the surface of the skin. Therefore, treatments that focus energy about 1 mm to about 8 mm below the surface of the axillary skin may be beneficial in treating axillary sweating.

0032For the purposes herein, eccrine sweat glands, apocrine sweat glands, and apocrine sweat glands may be referred to separately or collectively as sweat glands or target structures. Similarly, the terms therapeutic, therapeutic effect, therapeutic extent / area may also refer to the treatment of target tissue and / or any target structure present therein for the purpose of temporarily or permanently reducing or stopping ablation. The treatment itself is one or more of the methods of modification, inactivation, disabling, denervation, injury, electroporation, apoptosis, necrosis, coagulation, ablation, and destruction, target tissue and / or target structure. May affect.

0033While the methods and devices disclosed herein are intended to reduce sweat production in the sweat glands, the disclosed methods and devices can be modified to modify various types of target tissue and non-target tissues in the skin. Note that it may be used to treat target tissue areas. For example, the treatments disclosed herein include, in certain embodiments, (1) tightening the skin, reducing wrinkles by treating collagen, contouring the skin, inducing collagen formation, and / or Temporarily or by treating collagen, (2) treating sebaceous glands in the dermis layer of the skin, (3) stimulating or delaying hair growth, or treating hair follicles It is believed that it can be used to permanently remove and / or (4) treat cellulite for weight loss and / or body shaping purposes.

0034(Specific embodiment) (A. Energy transfer therapy) One approach to reducing sweat production involves thermally treating the target tissue by either delivering energy to the target tissue or extracting energy from the target tissue. The system can be configured to include a processor, an energy generator connected to the processor, and a device operably attached to the generator. The device can further include an energy delivery applicator or energy delivery element for delivering energy to the target tissue. In the illustrated embodiment, the cable electrically connects the device to the energy generator. In other embodiments, the processor, device, and / or energy generator can be wirelessly connected, for example, via a radio frequency signal.

0035For the purposes of this specification, the terms "electrode", "antenna", "energy", "energy element", "energy delivery element", "energy delivery applicator", or "energy source" may be used individually or. Collectively, adapted and applied in a range, strength, and / or amount sufficient to treat the target skin tissue directly or indirectly (eg, by heating the mediator), either thermally or by other means. , Electromagnetic, X-ray, radio frequency (RF), DC current, AC current, microwave, ultrasonic (including high-density focused ultrasonic (HIFU)), radiation, near-infrared, infrared, light / laser, cooling , And, but are not limited to, one or more types of energy transfer modalities, including, but not limited to, cryotherapy. It should be noted that while one particular modality may be disclosed in a particular embodiment, the embodiment can be adapted to adapt to other forms of energy transfer. It should be understood that such a mechanism can be employed by this embodiment, even if the mechanism of energy transfer is significantly different from that disclosed in the illustrated embodiment. For example, the energy generator in one embodiment can generate an electrical signal with the desired frequency, amplitude, and power level, and the cable can transmit the generated signal to a device with electrodes. In this embodiment, the processor communicates with the energy generator to control the power output of the energy generator to provide the desired amount of energy to heat the target tissue. Alternatively, in embodiments where the device comprises a Pelche electrode, the energy generator can supply a voltage to the device to thermoelectrically cool the target tissue.

0036In embodiments relating to the delivery of thermal energy, in one embodiment it is desirable to reach a temperature of at least about 50 ° C in the target tissue and / or the target structure therein in order to achieve the desired therapeutic effect. Let's go. For example, delivering sufficient thermal energy to heat the target tissue to about 60 ° C would probably result in thermal ablation of the target tissue. In an embodiment relating to the step of cooling the target tissue, it is believed that cooling the target tissue from about 0 ° C to -40 ° C will probably have a therapeutic effect on the target tissue.

0037(Microwave energy delivery device) The system illustrated in FIG. 3 includes an energy applicator 111 for non-invasively delivering microwave energy 112 to the target tissue 105 and a microwave generator 113 for supplying microwave energy 112 to the applicator 111. Indicates a device 110 having and. In this embodiment, the energy applicator 111 comprises one or more antennas for delivering microwave energy 112 to the target tissue 105. The antenna is configured to heat and treat the target tissue 105 and the target structure within the target tissue 105 when the device 110 is placed on or near the patient's skin. The treated tissue can either be left in place for reabsorption by the body's immune system and wound healing response, or it can be removed using any number of minimally invasive techniques. .. As shown, the antenna may also have the following horn shape to provide a directional component to the energy field. In one embodiment, the energy generator 113 is located remote from the energy applicator 111, and the generator 113 can be either stationary or mobile. Alternatively, the applicator 111 and generator 113 can be coupled to include a portable unit. Still as an alternative, the applicator 111 and generator 113 can be combined into a single unit.

0038Microwave energy is absorbed by the tissue in a process called dielectric heating. Molecules in tissues such as water molecules are electric dipoles, which have a positive charge at one end and a negative charge at the other end. As microwave energy induces an AC electric field, the dipole rotates in an attempt to align with the electric field. This molecular rotation produces heat as the molecules collide with each other and cause additional motion. Heating is particularly efficient with liquid water molecules with relatively high dipole moments.

0039Delivery of energy to the target tissue can be facilitated by an antenna design that incorporates a dielectric element. Microwave energy is delivered over a dielectric material, unlike other forms of electrical energy delivery, such as radio frequencies, where energy is typically transmitted through a direct electrical contact between a metal conductor and body tissue. be able to. The dielectric element does not prevent microwave energy from radiating to adjacent tissue, but may help optimize the delivery of energy to the target tissue over the course of treatment. Because the dielectric heating properties and thermal conductivity of skin tissue change over the course of treatment (eg, as the temperature rises) due to water loss, a dielectric that is properly matched to the antenna design will provide energy to the target tissue. Delivery can be maintained.

0040The effect of the dielectric on the energy delivery properties of the antenna decreases with distance from the antenna. Therefore, in order to optimize energy delivery to the target tissue over the course of treatment, in one embodiment it may be desirable to place the dielectric directly next to the antenna rather than placing it remotely from the antenna. Therefore, the antenna design can be optimized by incorporating a coating with a dielectric (eg, ceramic, PTFE, polyimide, etc.) with a dielectric constant consistent with the amount of heat required for treatment. The dielectric may be incorporated into the antenna or may be a separate component of the energy delivery device or system. Further details regarding antenna design are discussed below.

0041FIG. 4 is an isometric view depicting a non-invasive energy delivery device 117 with a plurality of microwave antennas 120 electrically connected to the microgenerator 113. In one embodiment, the antenna 120 is contained in a substantially planar applicator plate 121 that is sized for application to the target area of the patient's skin 119. In one embodiment, the device 117 and the applicator plate 121 therein can be sized and configured to substantially match the area of tissue being treated. For example, in the treatment of reducing axillary sweating, device 117 can be configured to cover substantially the entire axillary region of the patient. Alternatively, device 117 can be configured to cover at least a portion of the axilla. In addition, the applicator plate 121 may be flexible to help the device 117 fit the contours of the patient's skin 119.

0042FIG. 5 is a cross-sectional side view of the device of FIG. 4, showing the delivery of energy 112 into the skin. In such a multiplex antenna embodiment, it may be useful to orient the antenna 120 along the same plane in the same longitudinal direction to deliver the energy 112 in a plane. As shown in FIGS. 4 and 5, four or five microwave antennas 120 are arranged parallel to each other. In other embodiments, fewer or more microwave antennas 120 may be provided, for example 1, 2, 3, 5, 6, 7, 8, 9, 10, or more. This planar construction allows energy to be delivered to a larger tissue area in a single treatment and in a more consistent manner.

0043As described later herein, heat protection measures can be adopted in conjunction with heat treatment. As shown in FIGS. 4 and 5, the applicator plate 121 containing the antenna 120 may be connected to the microwave generator 113 by a conduit 114, and the cooling fluid may flow from the coolant circulator 118 to the applicator plate 121. It reciprocates and passes through the conduit 114. The cooling fluid creates a protective area on the patient's epidermis 103, so that the target tissue 105 below the protected area is treated.

0044The amount of energy 112 delivered to the target tissue 105 and the extent resulting from the therapeutic effect can be adjusted based on the number of antennas 120, their specific configuration, and the power delivered to each antenna. In one embodiment, a microwave generator 113 with an output frequency of microwave energy 112 in the range of 300 MHz to 20 GHz is suitable for powering the energy delivery device 117. In another embodiment, a microwave signal somewhere from about 915 MHz to about 2450 MHz is preferred to produce a therapeutic effect on the tissue. Alternatively, signals with frequencies in the range of about 2.5 GHz to about 10 GHz may also be preferred. In addition, solid-state, traveling-wave tubes, and / or magnetron components can optionally be used to facilitate the delivery of microwave energy 112.

0045With respect to antenna design, FIGS. 6A-6G illustrate some possible antenna variation examples that can be implemented to achieve the energy delivery functions disclosed herein. In each design, the antenna comprises the distal end of a coaxial cable supply line through which electrical energy is transmitted from the energy generator. The coaxial cable further comprises an inner conductor shaft 124 and an outer conductor 125. FIG. 6A shows an embodiment of the monopole antenna 122. As shown in FIG. 6E, the antenna may be shielded or blocked by metal 127 to limit the electromagnetic field propagated by the antenna. In such a unipolar configuration, the inner conductor element 123 extends beyond the outer conductor 125 from the inner conductor or shaft 124 so that the electromagnetic field propagated by the antenna originates only from the inner conductor element 123. In the dipole antenna 128 configuration as illustrated in FIG. 6B, the outer conductor 125 is exposed in such a way that an electromagnetic field is generated between the inner conductor element 123 and the outer conductor 125.

0046Depending on the desired performance of the antenna, the antenna may optionally include a spiral antenna 129 (FIG. 6C), a loop antenna 130 (FIG. 6D), or a horn antenna 131 (FIGS. 6F and 6G). These alternative antenna configurations provide a geometric radiation pattern. For example, as illustrated in FIG. 6F, the outer conductor 125 provides a directional component to the electric field generated between the inner conductor element 123 and the outer conductor 125, such as a horn shape. You may prepare. Optionally, the outer conductor element 125 and / or the inner conductor element 123 may be bounded, connected to, or covered by a dielectric element to optimize the energy delivery capability of the antenna. ..

0047In another embodiment of energy delivery to the target tissue, the energy applicator comprises an antenna connected to a coaxial cable connected to a microwave power source. As illustrated in FIG. 7A, the antenna 132 further comprises an internal conductor located within the coaxial cable 133, the internal conductor element 123 extending beyond the distal end of the coaxial cable 133 and coiling. Form a conductor element. The coiled conductor element provides a relatively flat structure that can be aligned with the skin surface, delivering an equal amount of energy to the plane of the target tissue. The applicator may optionally further include a thin shield made of polymer or ceramic at its distal end. 7B and 7C illustrate additional embodiments of the coiled antenna configuration, the coiled conductor element may include either coaxial cable 133 or internal conductor 123 only.

0048Note that FIG. 7A shows the use of cooling fluid flowing through the coaxial antenna system 132. This antenna embodiment, or any other antenna configuration previously shown, for example in Figure 6E, not only cools the skin, but also creates a lower pressure area inside the device chamber than in the surrounding environment. It can also be configured to generate. This area of lower pressure or suction within the device (1) adheres the device to the skin and juxtaposes the target tissue closer to the antenna, (2) reduces blood flow in the target tissue, thereby tissue. Helps to enable more efficient heating of the.

0049In addition, aspiration helps control pain by inducing stretch and baroreceptors in the skin, thereby blocking the pain signal through the phylum control theory of pain management. The phylum control theory believes that excess neural signals arriving at the dorsal root ganglion of the spinal cord overwhelm the system, obscuring or blocking the transmission of pain receptor signals to the brain. This pain management mechanism is utilized by implantable electrical pain control units, TENS systems, Optilase systems, and others.

0050Since microwave heating is particularly efficient when water molecules are present in the tissue, it may be desirable to have a relatively high water content or molecular density in or within the target tissue. This high water content and at the treatment point results in further microwave energy absorption and consequent heating. This phenomenon also allows selective heating of the target tissue, thereby minimizing its effect on non-target tissue.

0051There are a number of ways in which the water content in the target tissue can be achieved. For example, by injecting a bolus dose of fluid (eg, water, saline, etc.) into the target tissue or target structure, such areas are made more susceptible to microwave therapy. FIG. 8 shows an embodiment of injection of fluid 116 near the base of the sweat glands and target tissue 105. In the case of the target sweat glands, the patient can be induced to sweat in the therapeutic area (eg by increasing the ambient temperature or the temperature of the target area) in order to achieve a higher water content in the target structure. In any of these cases, water-dense sweat glands can be blocked to prevent either water / sweat from escaping through the sweat ducts. Sealing the ducts can be achieved by using an aluminum ion-based topical product such as an antiperspirant or any kind of biocompatible polymer coating.

0052Further non-limiting examples of embodiments of microwave systems, devices, and methods, and components of embodiments that can be utilized with those described herein, are, for example, referred to in their entirety. Previously incorporated by reference to Figures 3-9 and 20-26 of US Provisional Application No. 61 / 013,274, and pages 11-20 and 34-48, as well as throughout, which was previously incorporated by. It is described in Figure 1-25 of US Provisional Application No. 61 / 045,937, as well as pages 9-18 and 56-69. In addition, the embodiments and components of the embodiments described herein, and, for example, those discussed in the preamble, are previously incorporated by reference in their entirety, US Provisional Application No. 61. It can be used to generate tissue contours, illustrated in Figures 26-51 of 045,937 and as described on pages 18-39.

0053(RF energy delivery device) Radio frequency (RF) energy is another aspect of electromagnetic energy delivery that can be used to treat target tissue. In one embodiment, a device comprising at least one electrode for delivering electric field therapy is operably connected to an RF generator for delivering RF energy to the target tissue through the electrodes. Energy delivery can be continuous or pulsed, thermal or non-thermal. For example, a continuous or pulsed electric field delivered from the electrodes can heat the target tissue to the temperature required to achieve the desired therapeutic effect. Alternatively, the delivered energy heats and / or excises nerves, neuromuscular junctions, and / or neuromuscular junctions associated with the target structure in order to temporarily or permanently paralyze the nerves of the target structure. be able to. Pulsed electric fields can also induce electroporation in these neural structures or target structures themselves to achieve therapeutic effects.

0054The electrodes can be individual electrodes that are electrically unrelated to each other, split electrodes with commonly connected contacts, or continuous electrodes. The split electrode can be formed, for example, by providing an insulating tube with a slot in which the electrode is placed, or by electrically connecting a series of individual electrodes. The individual electrodes or groups of electrodes can be configured to provide bipolar signals. Electrodes can be dynamically assigned to facilitate unipolar and / or bipolar energy delivery between any of the electrodes and / or between any of the electrodes and one or more external ground pads. Or can be wired and connected. For example, the array of electrodes can be configured so that both unipolar and bipolar energy fields can be selectively, continuously and / or simultaneously delivered. The ground pad can be externally attached, for example, to the patient's skin (eg, to the patient's legs).

0055There are a wide variety of configurations of active electrodes, either in unipolar or bipolar configurations. They may be flat or curved to promote uniform contact over the electrode surface. The contact area of the active electrode may be circular (eg, annular, elliptical) or linear (eg, square, rectangular, polygonal) and can be of virtually any shape. The shape may be selected, for example, to suit the tissue to be treated or to allow optimal coverage for repeated activation. For example, in one embodiment, an electrode with a hexagonal contact area may provide the advantage of providing complete coverage when treating irregular regions through multiple activations. It will be appreciated that similar shapes may be used for the applicator plate in the microwave embodiments discussed herein. The number of electrodes may vary to allow patterned delivery of energy to the tissue, with at least one active electrode for unipolar and at least two active electrodes for bipolar. Desired. Multiple electrodes can be configured with many different patterns, such as an annular pattern, a radial pattern, a rectangular arrangement, or an approximation of any of the shapes described herein. 9A-F show the top and side views of the alternating electrode configuration shown in FIG. 9A, the top view and isometric view of the alternating plane configuration electrode shown in FIG. 9B, the three-pronged electrode shown in FIG. 9C, and FIG. 9D. A number of possible configurations of the bipolar electrode 201 for the desired therapeutic area 105 are shown, including the sandwich configuration electrode shown, the flat plate construction electrode shown in FIG. 9E, and the plated roof construction electrode shown in FIG. 9F.

0056The depth of energy penetration, the tissue temperature achieved, and the degree of tissue effect caused by the RF delivery device are the power delivered by the RF generator, the spacing between one or more electrodes, the size of the electrodes, and the extent of the electrodes. It depends on a number of factors, including orientation, the amount of electrode contact with the target tissue, and the nature of the tissue itself.

0057The generator operates on a conventional sinusoidal or non-sinusoidal waveform in one embodiment at frequencies ranging from about 200 KHz to about 1.25 MHz, more preferably from about 400 KHz to about 1.0 MHz. It may be. Such power supplies are available from many private suppliers such as Valleylab, Aspen, and Bovie. Depending on the desired therapeutic effect, it may be necessary for the generator to operate at relatively low and relatively high voltage and power levels. For example, the operability of the generator may include some power from about 1 / 2W to about 100W. In some embodiments, it may be desirable to continuously deliver energy over a period of as short as 1/4 second or as long as 300 seconds to achieve the desired therapeutic effect.

0058For embodiments that require delivery of a pulsed electric field (PEF), the PEF parameters can be voltage, electric field strength, pulse width, pulse duration, pulse shape, pulse count, and / or pulse in any range and combination. It may include, but is not limited to, intervals between them (eg, load cycles). Suitable pulse widths include, for example, a width of at least 10 seconds up to about 500 ms. Suitable shapes of pulse waveforms are, for example, AC waveform, sine wave, sine wave, combination of sine wave and cosine wave, DC waveform, DC transition AC waveform, RF waveform, square wave, trapezoidal wave, exponentially attenuated. Includes sine waves, and combinations thereof. A suitable number of pulses includes, for example, at least one pulse. Suitable pulse intervals include, for example, intervals of less than about 10 seconds. These parameters are provided for illustration purposes and should never be considered limiting.

0059In the embodiment illustrated in FIG. 10, the RF delivery device 202 comprises one electrode tip needle, microneedle, or stylet for insertion into or across the epidermal layer 102 of the skin. It can form the above energy delivery element. Alternatively, the entire energy delivery element can include electrodes that are optionally insulated at points along elements where energy delivery is undesirable (eg, non-target tissue). This minimally invasive insertion approach allows for more localized treatment of target tissue 105 so that damage to non-target tissue is minimized. After insertion of the needle 203 to a reasonable depth, preferably at the depth of the target tissue, but may be greater than or less than that, the operator is required to deliver to the target tissue 105 for further use. The RF generator 204 can be instructed to deliver an electric field to the electrodes. The electric field from the electrodes resistance heats the target tissue 105. When the target tissue 105 is outside the electric field and therefore outside the resistance heating region, the target tissue can be conducted conductively heated by the adjacent tissue that is resistance heated by the electric field of the electrode.

0060Another potential benefit of having an intervening needle insulated along its length is to avoid unnecessary heating of non-target tissue via heat conduction from the needle itself. As the electrodes resist heat the surrounding tissue during RF treatment, the electrodes also absorb heat from the tissue. The heat absorbed by the electrodes may then be conducted to the rest of the needle, in which case the heat may be undesirably passed to the surrounding non-target tissue. The needle 203 configured with the insulating shaft 205, as illustrated in FIG. 10, can prevent heat conduction to the non-target tissue along the needle shaft 205. In this embodiment, the proximal portion of the needle is insulated to the depth of the non-target tissue, while the electrode 206 in the distal portion of the needle 203 is exposed to treat the target tissue 105. Alternatively, the tip of the electrode 206 can be partially insulated in a manner that provides a directional component for the delivery of RF energy. This directional urging may advantageously provide a means for delivering energy to non-target tissue and minimizing the resulting thermal damage.

0061Protective treatment may be used with certain embodiments (not shown). For thermal treatments such as RF energy or microwave energy, cooling systems, cooling elements, or cooling components as described elsewhere herein may be provided. In one embodiment, the cooling element may be used in combination with the insulating element, while in another embodiment the cooling element may be used as a substitute for the insulating element. When cryotherapy is provided (as further described below), protective therapy may include the step of heating a portion of the energy delivery device.

0062Depending on the area 105 of the target tissue being treated, the needle electrode 206 of FIG. 10 may have a length as large as, for example, about 1-10 mm, preferably about 8 mm. More preferably, the needle electrode 206 may have a length of about 2-5 mm in some embodiments. It will be appreciated that the length of the needle 203 may be optimized to be inserted to the depth at which the target tissue 105 is located.

0063In the embodiment illustrated in FIG. 11, the energy delivery device comprises a needle 208 configured for percutaneous insertion. The needle 208 further comprises a distal portion having one or more energy delivery elements 209 for delivering energy 210 to the target tissue 105. More specifically, this embodiment may include a needle 208 having one or more electrodes for treating the target tissue with RF energy 210. As mentioned above, a portion of the needle 208 can be insulated to provide a directional component for energy delivery. This directional component can favorably enable more controlled treatment and damage less non-target tissue. In one embodiment, the needle 208 is insulated so that energy is delivered towards the epidermis 102 and away from the subcutaneous 100 tissue. The electrode 206 provided on the needle 208 may have any suitable length to treat a single sweat gland or multiple sweat glands. Alternatively, a plurality of electrodes 206 can be placed spaced apart on the needle 208 to treat the plurality of sweat glands. To treat a region of the larger target tissue 105, the needle 208 can optionally be configured to translate angularly or "fan out" parallel to the target tissue 105. For example, the energy delivery element 209 can be rotatably coupled to the needle 208 so that it may translate parallel to the target tissue 105. A cooling source may be provided on the skin to protect the skin surface, epidermis 102, and parts of the dermis 101, as discussed in previous embodiments.

0064(Cryrotherapy device) Cryotherapy may offer an opportunity to provide a therapeutic effect on the target tissue. Since the collagen matrix of the skin is less sensitive to cold air, it is possible to cool the target structure without damaging the non-target skin tissue containing collagen. The embodiments depicted in FIGS. 10 and 11 can also be utilized to treat target tissue via cryotherapy. In these embodiments, an intervening element with one or more needles, stylets, catheters, or probes delivers cold fluid to at least one thermally conductive element adjacent to or near the target tissue. do it, It can be configured with one or more passages to provide treatment to the target tissue. The system is adjacent to provide cold fluids such as liquid nitrogen, liquid helium, liquid argon, liquid carbon dioxide, liquid nitrous oxide, liquid AZ-50, refrigerated antifreeze, refrigerated alcohol, refrigerated physiological saline, etc. Or can be configured to have a remote generator. The generator should deliver enough cold fluid to the device to reduce the temperature of the target tissue between about 0--40 ° C. In some embodiments, a temperature between about 0 and -10 ° C may be sufficient to induce necrosis of the target tissue, but this may be above the freezing point of the target tissue. On the other hand, temperatures below about -10 ° C may be sufficient to freeze the target tissue.

0065It may be desirable to circulate the cold fluid through an intervening portion of the device to maintain constant cooling therapy. For example, as illustrated in FIG. 12A, device 211 is configured with an intervening element 212 with at least two concentric tubes 213, 214. In this embodiment, the cold fluid can be delivered through the intervening element 212 to the thermally conductive element by the inner tube 213 and then circulated out of the intervening element 212 through the outer tube 214. .. In this embodiment, the outer tube 214 itself can be a thermally conductive element. Alternatively, as illustrated in FIGS. 12B and 12C, the intervening element 212 may be configured with a tubular coil 215 that resides either inside or outside the element 212. The cold fluid is delivered through the lumen of coil 215 to provide a thermotherapeutic effect on the target tissue.

0066In other embodiments, the device may comprise a cold balloon catheter and the thermally conductive plate comprises a balloon. In such a balloon configuration, a pressurized liquid such as nitrous oxide is delivered through the passage of the intervening element. When the liquid reaches the balloon, it undergoes an endothermic phase change so that it absorbs heat from the surrounding area and achieves a therapeutic effect on the target tissue.

0067Alternatively, an intervening needle or probe can be used instead of a cold balloon catheter to administer cryotherapy to the target tissue. For example, FIG. 12D shows an intervening element 212 with an inner tube 216 and an outer tube 217. The inner tube 216 comprises an inner lumen 218 so that liquid nitrous oxide travels from the proximal portion 219 to the distal portion 220 of the tube. The inner tube 216 further comprises at least one port or nozzle 221 along the distal portion 220 of the tube so that liquid nitrous oxide exits the inner tube 216. The liquid nitrous oxide is preferably fast and undergoes an endothermic phase change as it exits port 221 and the outer tube 217 is cooled by the nitrous oxide gas. In this embodiment, as the gas absorbs energy from the outer tube 217 with the thermally conductive element and the surrounding target tissue, the gas passes through the annular space between the outer tube 217 and the inner tube 216 and is an intervening element. Exit from 212.

0068The approach disclosed in Figure 12D allows for a more focused area of hypothermia. Nitrous oxide gas exits the distal portion 220 of the inner tube 216 at its lowest temperature and then absorbs thermal energy from the distal portion 1242 of the outer tube 217. After heat exchange with the distal portion 1242 of the outer tube 217, the gas travels towards and out of the proximal end 219 of the intervening element 212. Therefore, the distal portion 1242 of the intervening element 212, which is adjacent to the target tissue, is the coldest.

0069Various parameters of this cold system can be adjusted to modulate the temperature of the gas and vary the rate and extent of heat treatment. For example, the shape, size, and number of nozzle / port openings may be related to conduction and convection. The size of the ring-shaped space between the outer and inner tubes of the intervening element also affects the heat transfer properties of the device. In addition, the pressure of the nitrous oxide liquid also contributes to the heat exchange capacity of the treatment.

0070Cryotherapy may also be administered topically to treat target tissue beneath the surface of the skin. It may be desirable to use cryoprotectants in conjunction with non-invasive cryotherapy to minimize the risk of damage to the epidermis and other non-target tissues. As illustrated in FIG. 12E, cryoprotectants 222, such as ethylene glycol, glycerol, erythritol, or dimethylformamide, may be administered topically or by injection to minimize the therapeutic effect on non-target tissue 103. Can be applied through. The cryoprotectant 222 can also be used in conjunction with transdermal therapy utilizing the intervening elements discussed above. As shown in FIG. 12F, cryoprotectant 222 is used to generate a protected non-target tissue area 223 between the cold source 225 on the skin surface 119 and the thermotherapy area 224 of the target tissue. Can be done.

0071(Phototherapy) Another approach for treating target tissue comprises the use of phototherapy. This approach uses the unique optical properties of the target structure to determine the spectral characteristics of each structure. Light energy can be delivered to the target tissue at a wavelength that matches the spectral characteristics of the particular structure, such as selectively heating and treating the structure through light absorption.

0072Phototherapy can also be performed by coloring the target tissue or the area surrounding the target tissue and then delivering light energy to heat the coloring. For example, a colorant can be introduced into the target tissue and light energy with a waveform having a particular absorption for this color can be delivered from an internal or external source to treat the target tissue. The main advantage of this approach is the ability to selectively color the target tissue so that treatment can be localized to the target tissue with minimal impact on the non-target tissue. Phototherapy can be performed using a wide variety of light energies, including but not limited to lasers, ultrashort pulsed light ("IPL"), focused IP, infrared, and near infrared. These various light energies can be implemented in any number of energy delivery elements, including but not limited to lasers, light emitting diodes ("LEDs"), or light bulbs. Optionally, one or more filters can be used in conjunction with any of these energy delivery elements to remove unwanted wavelengths, including wavelengths absorbed by non-target tissues.

0073In one embodiment associated with phototherapy, chromophores (ie, colored molecules) are introduced into the target tissue. If the target structure is a sweat gland, the chromophore is introduced through the duct via local delivery, injected into the target tissue, or ingested by the patient so that coloration appears in the patient's sweat (ie, chromhidrosis). can do. For example, garlic sulfur compounds are known to be metabolized by the body to form allyl methyl sulfide (AMS), which is excreted from the body via sweat. Color can be delivered directly to the sweat glands by binding the chromophore to the sulfur of garlic, just as the chromophore binds to AMS after metabolism. After the appearance of color in the target tissue, an external source or energy delivery element (eg, a light emitting diode "LED") is a light energy source such as a laser or other light delivery system that is specifically matched to one or more chromophores. Can be delivered to selectively treat the target tissue. This light energy can travel non-invasively below the sweat ducts or beyond the layers of the epidermis and dermis to reach the target tissue. Alternatively, intervening devices that use fiber optics can deliver light energy directly to the target tissue.

0074In another embodiment associated with this approach, colored bioreabsorptive elements can be introduced into or around the target tissue. For example, as illustrated in FIG. 13, colored bioreabsorptive microspheres 226 can be deposited in or around the target tissue 105. Microspheres 226 can be injected into or around the target tissue 105 by syringe 227 as part of a bioactive solution, gel, or other carrier. Once deposited in or around the target tissue 205, the colored microspheres 226 can be heated by a laser beam 228 from a laser 229 that matches their particular color, thereby conducting the target tissue 105. It heats up to produce a therapeutic effect. These microspheres 226 are made of materials such as polytetrafluoroethylene (PTFE), polymethylmethacrylate (PMMA), or calcium hydroxyapatite (CaHA) and are microscopic by laser 229, which has a relatively small effect on tissue in its pathway. It can be colored to match the laser wavelength, which results in the most efficient heating of the sphere 226.

0075In phototherapy with the deposition of chromophores in or around the target tissue, delivery of the chromophores in the presence of a carrier solution may result in a broader and more even distribution of chromophores prior to treatment. Good. A wider and more even distribution of chromophores may result in a wider and more consistent therapeutic effect. For example, the chromophore may be suspended in a buffered or unbuffered saline carrier solution prior to treatment of the target tissue. As illustrated in FIG. 14, the carrier solution 230 has a hollow needle 231 at the planar junction between the dermis layer 101 and the subcutaneous layer 100 so as to generate a pathway for the movement of the chromophore. Introduced using. In addition, the carrier solution 230 may incorporate agents to enhance the distribution and / or effect of the chromophore, or to promote recovery after treatment.

0076In another embodiment associated with the phototherapy approach, a neurotoxin can be used as a mediator to carry the colorant to the nerve glands or neuromuscular junctions of the target tissue and / or target structure. Botulinum, such as botulinum type A toxin, to treat various neuromuscular and neuroglandular symptoms by binding to cholinergic neurons at these junctions and blocking the release of acetylcholine in the neuronal synaptic vesicles. It is generally known that fungal neurotoxins can be administered. This blockade paralyzes the nerves of the tissue at the junction, but the result is only temporary. By using toxins to color the nerve junctions of the target tissue and / or the target structure, these junctions are thermally excised, selectively paralyzing the nerves of the target tissue / structure, and more persistent. Light energy can be delivered to achieve a specific treatment.

0077In this approach, the toxin itself can be colored, or as an alternative, a chromophore chemically bound to the toxin may be used. In addition, the light energy delivered to the target tissue is specifically matched to the colorant to maximize the energy absorbed at the junction.

0078There are seven serologically different types of botulinum toxins designated A to G. A toxin is a double chain polypeptide with a 100 kDa heavy chain ("heavy chain") that is attached to a 50 kDa light chain ("light chain") by a disulfide bond. Heavy chains target and bind to cholinergic neurons in and around the injection site and are involved in helping light chains cross the membrane of nerve cells. The light chain is involved in carrying toxicity to neurons. Although the potential molecular mechanism of toxin poisoning of botulinum toxin is discussed here, other toxins such as butyric acid fungus toxin, tetanus toxin, exotoxin, diphtheria toxin, cholera toxin, lysine, or variants thereof, It may have the same or substantially similar mechanism.

0079In this approach, it may be desirable to use only heavy chain fragments of the toxin as delivery mediators of colorants. Isolating the heavy chain fragment and excluding the light chain fragment from the toxin molecule avoids the introduction of toxicity into the body. In addition, the presence of light chain fragments can make it difficult to determine the success of heat treatment, as intact toxic molecules may provide a temporary therapeutic effect. Therefore, coloring the heavy chain toxin fragment or binding the chromophore to the heavy chain toxin fragment may result in a more attractive treatment. In some embodiments, 100 to 200 units of botulinum toxin is administered to the patient to treat the axillary region. Other doses may also be administered, depending on the desired clinical outcome.

0080In another embodiment, microneedle techniques can be employed to facilitate delivery of the chromophore to the target tissue. For example, the microneedles can be hollow to facilitate delivery of colorants (eg, liquid or solid chromophores, colored microspheres, etc.) to the target tissue. Alternatively, the needle may be configured to deliver the chromophore across only the stratum corneum from where the chromophore can move to the target tissue via reverse iontophoresis. In an additional embodiment, reverse iontophoresis is used to drive the chromophore directly across the epidermis into the deep dermis.

0081In another embodiment, as illustrated in FIG. 15, the needle tip 232 consists of at least one chromophore 233 and, when inserted into or along the target tissue, detaches from the needle 234. It is configured as follows. The needle tip 232 may be coated with a chromophore 233 or consist of a solid chromophore 233, and the needle shaft 235 may be solid or hollow. In the embodiment in which the microneedle 234 at the tip of the removable chromophore is adopted, the microneedle 234 can be optionally configured to engage the tip deployment mechanism 237. The tip deployment mechanism 237, such as a single plunger or an array of plungers, can be used to facilitate the attachment and detachment of the chromophore needle tip 232. For example, a hollow body needle 234 can be used to allow the deployment mechanism 237 to access the removable chromophore tip 232. More specifically, the deployment mechanism 237 can be driven through the lumen lumen 238 of the needle so as to engage and disengage the removable tip 232. Alternatively, the deployment mechanism 237 may include a hydraulic element, such as pressurized air, to cause the needle tip 232 to be attached or detached. In addition, or as an alternative, needle tip 232 and / or needle shaft 235 can be configured with pre-established vulnerabilities to facilitate deployment. For example, as illustrated in FIG. 15, the needle tip 232 is accompanied by a notch or groove 236 so that it breaks along the notch or groove 236 after insertion into or withdrawal from the target tissue. Can be configured.

0082The needles 234 shown in FIG. 15 may be joined in an array of needles, such as a linear or planar array. The needle 234 may have a length of about 2-8 mm, more preferably about 4 mm, and the length of the removable tip 232 coincides with the depth of the target tissue. The deployment mechanism 237, such as a plunger or an array of plungers, may attach and detach each needle separately, in a preferred order, or all at once.

0083In an alternative embodiment that employs a chromophore tip microneedle, the microneedle shaft is made of a soluble material such that the microneedle shaft dissolves after insertion into the skin, leaving the chromophore tip in the target tissue. For example, the microneedle array can be cast and cured with a distal tip with a chromophore and a proximal shaft with a sucrose solution. Once the microneedles are inserted into the skin, the sucrose shaft breaks down in the interstitial space of the skin tissue so that the tip of the chromophore is the only part that remains in the skin. In this embodiment, it is desirable to incorporate a flexible backing substrate so that after insertion into the skin, the backing can be detached from the microneedles, leaving a portion of the needle shaft and the tip of the chromophore in the skin. You may.

0084Optionally, a hollow microneedle can be utilized as a pathway for the delivery of light energy from an extracorporeal energy source to the deposited colorant. Alternatively, the microneedles may be provided with fiber optic material to facilitate the delivery of light to the color in the target tissue.

0085In the above embodiments that provide color delivery to the target tissue, various mechanisms can be employed to minimize the effects of any structure or color fragment left after treatment. For certain colored liquids, gels, and solids, laser delivery can be configured with sufficient intensity and duration to excise and evaporate some or all of the deposit. In the case of bioreabsorptive implants such as microspheres, the implant may eventually be absorbed into the surrounding tissue so that there are no harmful physiological or aesthetic effects due to the presence of microspheres or color. In addition, or as an alternative, the remaining color can be decolorized by light at therapeutic or alternating wavelengths so that it is no longer visible on the skin. Alternatively, the chromophore does not have to be bioreabsorptive or depigmenting, but rather the light energy crushes the chromophore into particles small enough to be phagocytosed by the immune system and removed from the body. May be good. This mechanism of action is well known in the field of tattoo removal, for example, where carbon black tattoo ink is crushed by laser light and removed from the body.

0086In another embodiment incorporating a chromophore tip microneedle, the chromophore tip is configured to be removed from the target tissue along the needle. In this configuration, the tip is not removable from the needle shaft. The configuration of the microneedle 239 that retains this prototype is illustrated in FIG. The needle 239 is a proximal portion 240 made of an optically transparent material or an optically neutral chromophore (ie, cannot be absorbed, blocked, or activated by a therapeutic wavelength). And a distal portion 241 made of chromophore. As light energy is delivered across the proximal portion 240 of the needle and absorbed by the colored distal portion 241 the distal portion 241 begins to heat, thereby conductively heating and treating the surrounding target tissue. To do. Alternatively, the proximal portion 240 of the needle 239 can be configured as an optical pipe or lens to concentrate light energy on the chromophore tip 232.

0087In embodiments that utilize non-detachable chromophore-tip microneedles, it may be desirable to incorporate an array of needles into an optically neutral backing system. Includes a chromophore tip and an optically neutral shaft, configured with shape and needle density to optimize treatment of the target tissue, this arrangement to form a microneedle patch. , Can be permanently connected to an optically neutral backing system. After insertion of this patch into the patient's skin, the light energy is transferred to an optically neutral backing so that this energy is delivered via an optically neutral shaft and absorbed by the tip of the chromophore of the needle. Can be applied. The absorbed energy heats the chromophore tip, thereby treating the surrounding target tissue. The patch can be of any size, shape, and shape required to match the therapeutic area. Optionally, the patch backing may be provided with a flexible material to allow the patch to fit the patient's skin. The backing system may also include an optically neutral adhesive on the part closest to the skin to minimize patch movement during treatment. The use of adhesives may provide significant benefit in avoiding patient discomfort due to treatment targeting errors or needle movements.

0088In any of the above embodiments relating to microneedles or microneedle patches, it may be beneficial to incorporate the adhesive, backing, or agent into the proximal portion of the needle shaft to facilitate heating of the non-target tissue. May be good. The needle or patch can optionally remain inserted into the patient's skin after treatment of the target tissue to act as an integral bandage. These healing agents may include anti-inflammatory agents such as steroids, non-steroidal analgesics, or antibiotic creams. Alternatively, the needle may be completely or partially coated with a chemical such as a hardener to enhance the treatment of the target tissue.

0089In embodiments that incorporate microneedle patches with optically neutral components, energy is delivered once a certain threshold is reached to prevent unnecessary damage to target and / or non-target tissue. It may be desirable to configure the system to block. For example, an optically neutral backing, adhesive, and / or needle, when a specified amount of energy is transmitted through the system, causes at least a portion of its components to become optically opaque to the therapeutic wavelength, thereby making it optically opaque. It can be designed to prevent additional energy from reaching the chromophore tip and heating the target tissue. Alternatively, these components can be heat or temperature sensitive so that once the target or non-target tissue reaches a defined threshold temperature, energy delivery is blocked. Alternatively, the backing material may be configured to be opaque, blocking light delivery to all but the proximal needle shaft extending through the backing material to the top surface of the alignment system, thereby blocking light delivery. Blocks light delivery to all tissues except those that are in direct contact with the tip of the chromophore.

0090In any of the phototherapy applications, it may be desirable to monitor the absorption of the light spectrum in the tissue in order to detect changes in the absorption spectrum. Changes in tissue absorption properties indicate changes within the tissue and can be used to detect the effectiveness of treatment, control the extent of treatment, and confirm the completion of treatment.

0091(Induction heating) Another method of providing a therapeutic effect to the target tissue involves inducibly heating the particles in or around the target structure. These particles are preferably metal (eg, iron) and are of a size that can be introduced into the target tissue region non-invasively or minimally invasively. For example, a solution of micro-sized ferromagnetic particles can be introduced into the target tissue via syringe injection. Alternatively, it may be easier to reach the target tissue using magnetic nanoparticles. Once one or more particles (eg, ferromagnetic particles) are present in or around the target tissue, an electromagnetic energy source, either inside or outside the body, creates an electromagnetic field to current the metal particles in the body. Can be generated. These currents cause resistance heating of the particles and the resulting conduction heating of the target tissue. The electromagnetic energy source can continue to deliver energy to the particles until the treatment of the target tissue is complete.

0092If the target tissue is one or more sweat glands, the particles may be locally introduced through the sweat gland ducts. Topically applied particles can be introduced into the sweat gland ducts, as well as aluminum ion particles in the antiperspirant, which are sent downwards into the sweat gland ducts and prevent sweat from reaching the skin surface. As illustrated in FIG. 17, these particles 242 can naturally move down the tube 109 into the coiled glands. Alternatively, pressure can be used to facilitate the progression of particles 242 to the sweat glands. Alternatively or optionally, iontophoresis may facilitate the delivery of the metal particles 242 into the sweat glands. As mentioned above, electromagnetic energy 243 to heat particles 242 and surrounding target tissue 105 until treatment is complete (eg, sweat gland production ceases and / or sweat glands are thermally excised). May be delivered from the electromagnetic energy source 244.

0093It should be appreciated that virtually all phototherapy with respect to color delivery to the target tissue discussed herein can be modified to deliver metal particles for induction heating therapy. For example, ferromagnetic particles can replace the chromophore, ferrofluid suspension can be used instead of the coloring solution, and iron-tip microneedles are used instead of the chromophore-tip microneedle. be able to.

0094It may be desirable to remove ferromagnetic particles from the body after treatment. As such, microneedle patches may be employed that include a non-magnetic backing system, a non-magnetic needle shaft (or a proximal portion of the shaft), and a non-detachable iron-tip microneedle. Optionally, this embodiment can incorporate the electromagnetic element 245 directly into the backing material 1249, as illustrated in FIG. 18A. The electromagnetic element 245 can be any structure or material that has electromagnetic properties and is electrically connected to an energy source, such as a metal wire. The electromagnetic element or source delivers an electromagnetic field 246 to resist heat the tip 247, thereby treating the target tissue 105. After treatment, the microneedle patch 248 is removed from the patient along with the non-detachable ferromagnetic tip 247.

0095Ultrasonic energy can be used as an alternative means of treating the target tissue. For example, ultrasonic heating can be induced by delivering ultrasonic waves to the target tissue and vibrating and heating the tissue. Approximately 0 ~ 50W / cm2Wave frequencies between about 20kHz and about 18MHz, with power in the range of, can achieve these results. Treatment is at frequencies between about 0.1MHz and about 3MHz and 720mW / cm2From 50W / cm2It may be more effective in power up to.

0096In intensive ultrasonic therapy, one or more ultrasonic transducers emit waves that are focused at a specific focal point at a specified distance from the transducer. As shown in FIG. 18B, the focusing of these waves 249 from the ultrasonic transducer 251 causes a strong cumulative effect at focus 250. Once each wave 249 passes through focal 250, it continues and distributes along its radial path. The embodiments of the plurality of oscillators may be oriented in any number of configurations, including linear, radial, and hemispherical arrangements.

0097In treatment using a planar ultrasonic transducer, the radiated waves are not focused at a particular point. Instead, as shown in FIG. 18C, the wave 249 travels in a plane from the edge of the oscillator 252. In addition, the ultrasonic signal can be terminated at a given distance and attenuated so that it does not propagate into deep non-target tissue. Both the planar 252 and the focusing 251 oscillators may induce ultrasonic heating. Used in conjunction with techniques for protecting non-target tissue (eg, cooling systems / elements) as described elsewhere herein, both ultrasonic methods heat the target tissue. Can be isolated.

0098(Chemical thermal reaction) Another method for reducing sweat production is illustrated in FIG. In the illustrated embodiment, the sweat glands are thermally disabled by a controlled chemical reaction. This chemical reaction can be either exothermic or endothermic and can involve one or more components. The components can reside in one or more chemical containers 253 communicating with the intervening probe 254. The probe 254 comprises at least one cavity 255 communicating with the chemical vessel 253, a sharp tip 256 for penetrating the skin and entering the target tissue, and a heat conductive material (eg, a metal such as copper). It is equipped with a heat conductive element 257. The thermally conductive element portion 257 of the probe 254 is configured to be located adjacent to the target tissue. In one embodiment, a portion of the skin 177 is lifted such that the probe 254 with the sharp tip 256 approaches the target tissue parallel to the skin and allows the tip 256 to puncture through the tissue. The heat conductive material 257 is placed in place on the probe 254 so that it is located in the target tissue area. Further details regarding this delivery mechanism will be described below. The components can be mixed and delivered simultaneously or continuously to react within the thermally conductive element 257. For exothermic reactions, in sufficient amounts, eg, acids (eg, HCl, H), to generate enough heat to neutralize and / or excise the sweat glands through conduction across element 257.2SO4) And water can be delivered into the thermally conductive element 257. In another embodiment, supersaturated sodium acetate is introduced into the thermally conductive element 257 and heat is generated as the solution crystallizes. In an alternative embodiment, the components can be mixed prior to introduction into the thermally conductive element 257. Optionally, the catalyst can be placed within the thermally conductive element 257 or elsewhere along the probe lumen 255 to facilitate the chemical reaction.

0099In another embodiment with respect to the target tissue, the solution can be used to carry the charge and treat the target tissue. In this embodiment, a conductive liquid such as a hypertonic solution (eg, saline) is injected into or around the target tissue with a syringe and needle and then charged by an electrode located in close proximity to the target tissue. Can be done. Alternatively, the needle itself may be provided with electrodes so that once placed in or adjacent to the target tissue, the solution is directly charged. For example, an array of microneedles (such as those shown in FIG. 14) that also have electrodes can be used to deliver the hypertonic solution to the target tissue, and the tissue is conducted through the solution after activation of the electrodes. It is treated by the charge.

0100Since sweat has already traveled from the close area of the sweat glands to the surface of the skin, it may be advantageous to use the conductivity of the sweat itself to reach the sweat glands. FIG. 20A-20C illustrates a method of delivering charge to the sweat glands via sweat. To prevent damage to the skin surface and surrounding tissues along the sweat gland canal 109, an insulating coating 258 is first applied to cover the skin surface and the walls of the canal 109, while sweat still surface from the sweat glands. It may be desirable to leave a path to proceed to. After application of insulator 258, by administering an injection of epinephrine or cholinergic agent or agonist, stimulating nerves with electrical signals, and / or raising the patient's temperature via exercise or other means. , Can induce the patient to sweat. Once the sweat reaches the surface of the skin, the operator can apply electrical energy 259 from an energy source (eg, RF generator 204) to the surface sweat. Through the electrical conductivity of sweat, electrical energy 259 from the energy source 204 can reach and disable the sweat glands. In some embodiments, it may be desirable for the operator to induce sweating throughout the treatment to maintain continuity of the conductive pathway.

0101(B. Chemotherapy) In another embodiment for treating a target tissue, a chemotherapeutic substance can be introduced into or near the target tissue to provoke a chemical reaction and the resulting therapeutic effect. For example, alcohols, acids, or bases can be delivered to the target tissue, much like chemical excision of tissue. More specifically, injection of a small amount of acid, such as trichloroacetic acid or alpha hydroxy acid, can provide a therapeutic effect. Ethanol with a concentration of 5% to 100% is used to treat hepatocellular carcinoma, thyroid gland, fibromas, and cysts in the body, and is used to treat the target tissues of the present application. Can be done. The chemotherapeutic agent can be delivered to the target tissue by any number of mechanisms, including syringes and needles, or microneedle patches as described elsewhere herein.

0102(C. Mechanical treatment) (Percutaneous resection) FIG. 21A-21C illustrates methods and devices for percutaneous resection of sweat glands. A probe 260 equipped with a retractable cutter or blade 261 can be inserted percutaneously under the target tissue 105 with one or more sweat glands. Optionally, imaging techniques can be used to facilitate the installation of the probe / cutter 260. The probe 260 is configured with a hollow chamber 262 such that the blade 261 forms the outer wall of the chamber 262. Chamber 262 is open when blade 261 is in the retracted position. When the blade 261 is engaged, the chamber 262 is closed. As illustrated in FIG. 21A, the probe 260 is placed under one or more sweat glands so that at least one sweat gland is supported by the wall of the engaged blade 261. When the blade 261 is withdrawn as shown in FIG. 21B, the sweat glands fall into the open hollow chamber 262. When the blade 261 is advanced and engaged, the sweat glands are sheared from the tube 109 into the probe chamber 262. It may be desirable for the blade 261 to rotate, vibrate, and / or oscillate to promote gland shear. Once the blade 261 is engaged, the sheared glands are contained within chamber 262 so that they can be removed with probe 260 after treatment or vacuum aspirated in synchronization with treatment.

0103(Plane cutting device) In another embodiment for treating the target tissue, the planar cutting device can be inserted into the target tissue through a small incision or puncture of the skin. The device shears, scrapes, and / or cuts the target structure within the target tissue in a horizontal, longitudinal, and / or angle in the plane of the target tissue to provide a therapeutic effect. It can be configured to move in parallel. More specifically, the device can travel across the junction between the dermis and subcutaneous layers of the skin, destroying or at least incapacitating the eccrine and apocrine sweat glands. ..

0104In one embodiment of the planar cutting device, the device can have a reduced contour configuration when inserted into the skin and an expanded contour when placed in the target tissue. For example, as illustrated in FIGS. 22A and 22B, a device 263 with at least one wire 264 in a thin configuration is inserted into an opening in the skin. After insertion into the skin, the actuator 265 can be used to bend the wire 264 into an extended contour and cut and disable the target structure within the target tissue during this expansion. In its extended contour, the wire 264 accesses a larger target tissue area for treatment. Optionally, the wire 264 can be expanded and contracted multiple times with the actuator 265 to produce a therapeutic effect. As shown in FIG. 22B, the actuator 265 may include an outer element 266 and an inner element 267. The medial element 267 comprises a shaft having a distal end 268 connected to a wire 264 and a proximal end 269 extending at least partially outside the patient. The outer element 266 may include a collar or sheath connected to the wire 264, and the reduction and expansion of the wire 264 can be triggered by the movement of the inner element 267 relative to the outer element 266.

0105In another embodiment, as illustrated in FIG. 23, the planar cutting device comprises a wind turbine cutter 270 that is placed into the target tissue 105 in a reduced contour configuration. The wind turbine cutter 270 consists of a handle 271 for insertion into at least a portion of the target tissue 105, and at least one blade 272 operably connected to the distal portion 273 of the handle 271. The blade 272 is configured to rotate around the distal portion 273 of the handle 271 so that the target tissue 105 and target structure within the blade path are damaged and disabled.

0106In another embodiment of the planar cutting device, a guiding wire can be introduced into the target tissue and delivered through the tissue so as to demarcate the plane of the tissue to be treated. As illustrated in FIG. 24, wire 274 is dug into target tissue 105 through two insertion points 275 in the skin. Once the wire 274 is placed to define the tissue area to be treated and each end of the wire 274 is placed outside the insertion point 275, the wire 274 pulls the wire 274 through the defined plane of the tissue. Tension can be applied to both ends. As the wire 274 translates through the tissue, it damages and disables the target structure in its pathway. In an alternative embodiment, as shown in FIG. 25, the wire 274 is inserted into the target tissue 105, guided across the target tissue 105 to demarcate the therapeutic area, and at a single insertion point 275 of the skin. It is configured to be sent out of the body through everything. Once the wire 274 is in place and both ends of the wire 274 are located outside the insertion point, the wire ends can be pulled so that the wire 274 passes through the treatment area.

0107In the plane cutting device described above, which utilizes an inductive wire, it may be desirable to feed the wire through the target tissue to delineate the plane of the target tissue for treatment. A digging instrument with a maneuverable tip can be used to facilitate wire positioning and routing within and through the target tissue. An excavation tool 276 with a proximal end 279 and a distal end 278 is shown in Figures 26A and 26B. Instrument 276 further comprises a hollow passage 277 for sending the guiding wire 274 from the proximal end 279 through the distal end 278 for installation in the target tissue. The distal end 278 of instrument 276 is configured for insertion through the skin into the target tissue. The proximal end 279 of the instrument is located outside the body and is used to facilitate insertion and positioning of the distal end. The instrument 276 further comprises a maneuvering actuator 280 at the proximal end 279 to position the distal end 278 of the instrument 276 and facilitate the placement of wires in the target tissue.

0108One of the planar cutting devices described herein can utilize the mechanical force driving a cutting element (possibly a wire or blade) through a target structure within the target tissue to achieve a therapeutic effect. Will be considered. However, it should be understood that the cutting elements of these devices may, likewise, or as an alternative, include an energy delivery element to treat the target tissue as the element moves through the tissue. For example, wire 274 in FIG. 24 can also be a resistance heating element connected to an extracorporeal power source, where the heated wire excises and coagulates the target tissue as it translates through the plane area of treatment. Alternatively, the wire can be an energy delivery element (eg, an electrode) for delivering one or more forms of energy (eg, radio frequency, microwave, ultrasound, etc.) to the surrounding target tissue. As an alternative, the wire and its electric field can be used to cut and shear the target structure as it passes through the therapeutic area.

0109(Photodynamic adhesive) Another method for reducing sweating, as illustrated in FIG. 27, is to fill the sweat gland duct 109 with a photodynamic adhesive. In this embodiment, the photosensitive dye 281 is introduced into the sweat duct 109 and the dye 281 is exposed to a fluorescent lamp from an external light source. Dye 281 is preferably introduced into the eccrine and / or apocrine sweat glands 106, 107 via topical application. With or without pressure support, dye 281 can be applied topically to access sweat glands 109 through the pores. Dye 281 can also be introduced into a gland or tube via injection. Upon exposure to light of the required wavelength and sufficient duration, dye 281 undergoes a chemical change through cross-linking of proteins in the dye. The crosslinked dye seals the sweat glands 109, thereby preventing sweat from reaching the surface of the skin.

0110In one embodiment, the Janus Green dye is delivered to the sweat duct. Optionally, pressure may be used to facilitate the delivery of the dye into the tube. Once the dye enters the tube, a laser source from outside the body can deliver about 650 nanometers of light to the tube, thereby bridging the dye and sealing the tube. Rose bengal and indocyanine green are other dyes that can be used for this purpose. In addition, albumin or other proteins can be added to the dye to promote sealing.

0111In another embodiment, the chromophore is mixed with a chemical agent, which causes the chemical agent and chromophore to react when exposed to fluorescent light. Specifically, the chromophore absorbs light, which in turn heats the chemical and converts the chemical into a seal, thereby preventing sweat from reaching the surface of the skin.

0112In any of the embodiments disclosed herein relating to the step of sealing the duct, such treatment optionally has a specific affinity for water (eg, microwave), or It can include the step of delivering energy specifically configured to be absorbed by water (eg, infrared). The application of energy to sweat-filled glands may result in selective treatment of these glands with minimal effect on surrounding non-target tissues or structures.

0113(Fibrin adhesive) Another method for sealing the sweat glands to reduce sweating involves introducing a biocompatible scaffold into the sweat duct. By introducing the scaffold structure 282 into the sweat duct 109, as illustrated in FIG. 28, fibroblasts 283 migrate from the skin onto the scaffold 282 as part of the body's healing response, permanently leaving the sweat glands 109. Form a scar tissue that seals in. Scaffold 282 can be a biodegradable fibrin hydrogel, such as a glycosaminoglycan chain attached to a synthetic polyamine. These scaffolds 282 can be introduced into tube 109 from the skin surface using a variety of delivery techniques, including injection, pressure, and iontophoresis.

0114(Inability to induce pressure) In another embodiment for reducing sweating, the sweat glands are disabled by utilizing the positive or negative pressure delivered from the skin surface to the sweat glands via the sweat ducts. In one embodiment of this approach, as illustrated in FIG. 29, the piston 284 is placed in the sweat gland so that the pressure gradient across the sweat gland wall is sufficient to cause a disabling rupture 285 within the coil portion 286 of the gland. Pressurized gas (eg, air) can be delivered. In one embodiment, pressures of at least about 200, 300, 400, 500, 600, 700 psi, or higher may be used. Sufficient pressure can also be achieved by using a volume displacement pump, syringe, or suction device.

0115In another embodiment, as illustrated in FIGS. 30A and 30B, the sweat glands are saturated with a liquid (eg, water) having a higher volume density as a liquid than as a solid. The liquid may be introduced into the sweat glands by topical application (eg, a patch), injection, or, if the liquid is sweat, by inducing the patient to sweat. Cold air is then applied to the liquid in the sweat glands using any number of cold techniques. As the liquid freezes, it expands and exerts pressure on the walls of the glands. The liquid continues to freeze, gradually increasing the pressure in the gland 286 until rupture 285 is produced in the gland and / or tube 109.

0116(Pressure-induced necrosis) Sweat glands may be more susceptible to ischemia than surrounding tissues. For example, Pressure-Induced Bullae and Sweat Gland Necrosis Following Chemotherapy Induction, The American Journal of Medicine (September 15, 2004,) which is incorporated herein by reference in its entirety. Volume 117) states that ischemia due to persistent local pressure may cause sweat gland necrosis. Therefore, another treatment to reduce sweat production is at a level sufficient to cause necrosis of one or more sweat glands in the area, either alone or in combination with other methods described herein. And for duration, it may include steps to apply pressure to the area of target tissue while minimizing ischemic damage to non-target tissue. A device 287 for causing pressure-induced necrosis of the sweat glands is shown in Figure 31. The device 287 may include a clamp or pliers 288 for engaging the skin at its distal end and an actuator 289 for the operator to apply and sustain pressure. Alternatively, the actuator 289 may further include a spring element 290 so that constant pressure can be maintained during treatment without the need for operator assistance or interference. Device 287 may include an array of clamps or pliers 288 so that multiple locations can be treated at one time. In an alternative embodiment, the device 287 may be configured to be worn by the patient over a period of hours or days to achieve the desired therapeutic effect. For example, a modified example of the device shown in FIG. 31 can be strapped to the patient's axilla so that it can be worn overnight or one day to achieve axillary anhidrosis. ..

0117(Acoustic cavitation) In another embodiment, microbubbles are introduced into the target tissue and hollowed out by the ultrasonic signal to achieve a therapeutic effect. For example, as illustrated in FIG. 32, encapsulated microspheres or microbubbles 291 (eg, GE). OPTISON®, sold by Healthcare, is delivered to the target tissue 105, whereby an extracorporeal energy delivery device (eg, ultrasonic transducer 292) is delivered to the target tissue 105 with energy 293 (eg, super). It delivers an ultrasonic signal) to burst the microbubbles / microspheres 291. The microbubbles 291 can be introduced into the gland either through local delivery via a tube 109 or by injection. The ultrasonic transducer 292 can be configured to deliver waves with sufficient amplitude and frequency to violently disrupt the microbubbles / microspheres 291 present in and around the target structure, thus the target structure. Sufficient energy is released to disable and provide a therapeutic effect. Alternatively, cavitation can be induced in the sweat glands by increasing the sonic pressure applied to the tissue above the threshold required to cause natural cavitation without the introduction of exogenous bubbles. Sodium and other ions in sweat may act as bubble formation foci. For example, the type of pressure provided by the shock wave crusher may be sufficient to generate this cavitation.

0118(i. Protection of non-target tissues) (Fever treatment to protect non-target tissue) In tissue heat treatment, it may be beneficial to protect non-target tissue from unnecessary and potentially harmful thermal destruction. This is especially the case for subcutaneous treatment, as the excess energy delivered to the epidermis and dermis layer of the skin causes pain, discomfort, dryness, carbonization, and peripheral effects. Also, drying, carbonization, and peripheral effects on surrounding tissue impair the effectiveness of treatment because the impedance of the dry tissue may be too high to allow energy to travel deeper into the tissue. obtain.

0119To avoid thermal destruction to non-target tissues and any annoying problems associated with them, energy delivery devices provide a cooling effect on superficial non-target tissues (eg, epidermis and dermis parts). Cooling elements can be included. By cooling the epidermis conductively and / or by convection and allowing the cooling effect to penetrate the dermis, the cooling element is for superficial non-target tissue as illustrated in FIG. Establish a thermal protection zone 103. The cooling element that provides this protected area 103 can treat the target tissue (eg, the thermal treatment area 105 in FIG. 33) with minimal risk of thermal damage to the non-target tissue.

0120To further reduce the risk of pain and / or other unpleasant sensations associated with heat treatment, the cooling element can further cool the superficial non-target tissue to produce an anesthetic effect. Depending on the type of heat treatment employed and the associated needs of complementary cooling, the cooling treatment and / or anesthetic effect may be applied before, during, and / or after the heat treatment. Protective cooling may also be applied alternately with thermal therapy to maximize energy delivery while minimizing adverse effects on non-target tissues.

0121The cooling element can take many forms. The cooling element may be a layer of a static refrigerated liquid (eg, water, physiological saline) or a solid coolant (eg, ice, heatsink), or some combination thereof (eg, a metal cylinder filled with cold water). It can be a passive heat sink that conductively cools the skin. The cooling element can also provide a spray or flow of gas or liquid, or active cooling in the form of aerosol particles, for convective cooling of the epidermis. A thermoelectric cooler (TEC) or Pelche element can also be an effective active cooling element. Alternatively, the active cooling element can include a thermally conductive element with adjacent circulating fluids to carry away heat.

0122The cooling element can also be incorporated into the device as an internal cooling component for conductively cooling the non-target tissue. For example, an energy delivery device can connect a cooling component to an energy applicator, in which case the cooling component can actively or passively provide conductive cooling to adjacent tissue. When passive cooling is provided, the cooling component may include a cold metal plate or block. When active cooling is provided, the cooling component may include a thermally conductive element, and a refrigerated liquid (eg, water, dry ice, alcohol, antifreeze) is circulated through the internal structure of the element. For example, in a microwave energy delivery device containing a dielectric, the dielectric itself can be a cooling component. In another example, the cooling component can be incorporated into the electrodes in embodiments where RF energy is delivered to the skin tissue.

0123As shown in FIG. 34A, the cooling component 115 can be incorporated into an energy delivery device 117 with at least one microwave antenna 120, as described above. In this embodiment, a fluid is used to cool the adjacent skin tissue 119. This convective cooling can optionally be enhanced by a coolant circulator 118, which may be integrated within, connected to, or remote from the energy generator 113. As shown in FIG. 34B, the cooling circulator 118 is located remote from both the energy source 113 and the energy applicator 111. The nature and properties of the circulating fluid (gas or liquid) (eg, medium, flow rate, temperature) are selected and modified to achieve the desired cooling effect in light of the amount and rate of energy delivered to the target tissue. be able to.

0124Cooling elements can also be used to provide directional components for heat treatment. For example, the needle 294 illustrated in FIG. 35A can be configured with a proximal region with a cooling element 295 and a distal end with an electrode tip 296. In this configuration, the thermal damage can be isolated to the target tissue, while the non-target tissue is cooled by the cooling element 295 to protect it along the proximal region of the needle. Optionally, the electrode 296 itself allows the internally circulated refrigerated fluid to conductally cool the tissue adjacent to the electrode 296, thereby minimizing unnecessary damage to non-target tissue. , Can be equipped with cooling components.

0125FIG. 35B shows an energy delivery element with a metal electrode 297, an inner tube 298, and an outer peripheral surface 299. In this embodiment, the metal electrode 297 comprises a cooling component. The energy generator supplies electrical energy to the metal electrode 297 to deliver an electric field to the adjacent tissue. The cooling component of electrode 297 cools the adjacent tissue conductively, and the coolant is delivered to electrode 297 through inner tube 298 and then through the annular space between inner tube 298 and outer peripheral surface 299. Is circulated.

0126Minimally invasive heat therapy, in which the energy delivery device delivers energy from a location close to or adjacent to the target tissue, utilizes surface cooling in addition to or instead of subcutaneous cooling to protect the non-target tissue. be able to. For example, FIG. 11 depicts an energy delivery device with a needle 205 that delivers energy 210 subcutaneously. The cooling element can be incorporated into this delivery device to provide protective cooling adjacent to the heat treatment, and / or, as shown, the cooling element protects superficial non-target tissue. Can be applied locally as such.

0127In another embodiment with minimally invasive treatment, the cooling element can be incorporated into the needle such that the proximal and distal parts of the needle have a cooling element. In this configuration, the electrodes or other energy delivery elements are so close that they are cooled to protect the superficial non-target tissue adjacent to the proximal cooling element and the deep non-target tissue adjacent to the distal cooling element. It can be located between the position and the distal cooling element. Therefore, fever treatment is regulated from above or below the therapeutic area so that treatment of the target tissue is localized.

0128It may also be desirable to utilize cooling elements to improve the efficiency of overall heat treatment. As mentioned above, heat treatment may be attenuated by overheating and drying of tissue adjacent to electrodes or other energy delivery elements. Due to the relatively high impedance of the dry tissue, energy delivery beyond the dry tissue is compromised, resulting in inefficient, inconsistent and potentially ineffective treatment. By incorporating a cooling element or cooling component in close proximity to the treatment site, excess heat can be absorbed by the energy delivery device and removed from the body. For example, the electrode or other energy delivery element can include a cooling component to extract excess heat from the electrode and adjacent tissue and promote thermal conductivity for deeper treatment.

0129In another embodiment, the heat pipe can be incorporated into the energy delivery element to absorb and expel excess energy from the therapeutic area. FIG. 36 depicts an energy delivery device 1200 with a bipolar pair of needle tip electrodes 1201 and 1202, the electrodes 1201 and 1202 located adjacent to the target tissue 105. A cooling component including a heat pipe 1204 is incorporated in these electrodes 1201 and 1202, and the heat pipe 1204 is connected to a heat sink 1203 located outside the body. The heat pipe 1204 operates on the principle of top cooling, whereby the fluid in the pipe 1204 (eg water, alcohol, ammonia, etc.) condenses rapidly so as to transfer heat along the pipe. And evaporate at the opposite end of pipe 1204. In this example, the heat sink 1203 draws heat away from the evaporated fluid in the proximal portion of the heat pipe 1204 in order to condense the fluid into a liquid. Once condensed, the liquid travels towards the electrode in the distal portion of the pipe and absorbs heat from the electrode and surrounding areas until it evaporates. The steam then travels upwards in the proximal portion of the heat pipe 1204 to initiate the heat exchange cycle again.

0130In another embodiment, the cooling element can incorporate a heating electrode to achieve the desired thermal protection. For example, as shown in FIG. 37A, a cooling electrode with a heat sink 1205 is placed between two pairs of bipolar needle electrodes 1206, 1207. Heat sink 1205 can be a thermally conductive metal with a high heat capacity. Optionally, the heat sink 1205 may further include a chamber for carrying a static or circulating cooling medium to absorb and carry away excess heat. In the example illustrated in FIG. 37A, the cooling element 1205 dissipates excess heat from the therapeutic area to protect non-target tissue while avoiding the adverse effects of dryness of the target tissue. The length is equal to the delivery elements 1206, 1207. In another example, as illustrated in FIG. 37B, the cooling elements 1209 are in alternating order with the unipolar electrodes 1208 so that the cooling elements 1209 primarily provide protective cooling to superficial non-target tissue. In addition, it is shorter than the energy delivery element 1208. In any of these embodiments, the cooling element 1209 may optionally include an electrically active element such as a thermoelectric cooler (TEC) or a Pelche element.

0131In applications where the target tissue is thermally treated using cryotherapy, it may be beneficial to provide a heating element to protect the non-target tissue from the undesired effects of cooling. As various modes of protective cooling are disclosed above for heat therapy, the same conduction and convection techniques are used in the same way, using heating elements to heat to protect non-target tissue in cryotherapy. Can be adopted. In addition to the modes of conduction and / or convective heat exchange already disclosed, the heating element also provides resistance, radiation, and / or induction heating to provide the required amount of heat to protect the non-target tissue. It can also be used. Such protective heat treatments can be applied in alternating order before, during, after, and / or with the application of cryotherapy, as if treating the target tissue.

0132(ii. Shape) In many of the embodiments disclosed herein, the treatment is administered topically and / or minimally invasively to achieve the desired therapeutic effect on the target tissue. In some of these embodiments, the skin is represented as a flat multi-layer of tissue, and treatment can be administered to the target tissue in a manner substantially perpendicular to that plane. Treatments may be disclosed for a particular skin shape (eg, vertical topical delivery, vertical transdermal insertion, etc.), but such treatments may be of any number or variety, including those discussed below. It should be understood that it may be administered with respect to the shape of.

0133(Rise skin treatment) In energy treatments involving delivery of RF, infrared, microwave, or ultrasound, for example, the delivered energy penetrates too deeply into the body, deep non-target tissue, related critical structures (eg, blood vessels, lymph nodes, muscle tissue, etc.) ), And there is a risk of causing harm to body organs. Therefore, it may be beneficial to raise the target tissue, which comprises a portion of the skin, from the underlying tissue. Such an increase can be achieved through manual intervention by the clinician or can be facilitated using any number of devices. For example, vacuum 147 can be used to pull and support skin 119, thereby raising the skin for treatment, as illustrated in FIG. 38. Optionally, a vacuum / suction device can be incorporated into the energy delivery device so that suction and energy delivery can be applied all at once.

0134In another embodiment, a tool utilizing a sterile adhesive can effectively support the skin for treatment. However, more simply, the clinician can use any number of clamps, tongs, or other devices for treatment and to achieve and maintain skin elevation during treatment.

0135(Non-vertical percutaneous insertion) For treatments with minimally invasive insertion of the therapeutic device, it may be desirable to administer the treatment by inserting the device into the skin tissue in a non-vertical manner. This approach may provide multiple benefits. First, the risk of reaching and damaging critical structures in the subcutaneous tissue may be minimized by inserting the device at an angle. For example, angular insertion may avoid blood vessels, lymph nodes, and muscle tissue located beneath the subcutaneous tissue. Second, the non-vertical approach may have a higher chance of achieving planar treatment. Since the target tissue is in a plane parallel to the surface of the skin, it is believed that the angular approach can produce a wider range of treatments per insertion.

0136For example, the device can be inserted diagonally into the skin and then dug between the dermis and subcutaneous layers, parallel to the target tissue area. As shown in FIG. 39, a needle 1210 with an energy delivery element can be delivered to deliver energy therapy to the target tissue in a planar manner. In this embodiment, the needle 1210 comprises an electrode, and as the needle is longitudinally withdrawn along its insertion path, a small portion 1211 of the needle is used to administer multiple treatments to the parallel plane of the target tissue. used. Alternatively, the electrode is slidably engaged inside the needle 1210 and treatment is by translating the electrode longitudinally along the needle 1210 while the needle 1210 itself remains in place. Be administered. In another alternative embodiment, the length of the needle 1210 is electrically insulated from the electrode so that the sleeve can be moved in parallel along the length of the electrode so that only a portion of the electrode is exposed at one time. A split insulator sleeve with a body (eg, polyimide) may be provided. As a further alternative, the needle 1210 has multiple electrodes (eg, unipolar, bipolar) that are dynamically activated simultaneously or continuously to produce a therapeutic effect across the plane of the target tissue. Prepare along.

0137In addition, it may be beneficial for the operator to manipulate the patient's skin to promote non-vertical insertion. By pulling, supporting, and / or squeezing the skin before, during, and / or after insertion of the device, the operator digs the device along the plane of the target tissue to achieve planar treatment. can do. This skin manipulation can be performed manually by the operator or facilitated by any number of devices, including those discussed above regarding skin elevation. As shown in FIG. 40, a vacuum suction 147 with multiple vacuum channels 1212 can be used to raise the skin 119 and facilitate non-vertical insertion of one or more energy delivery elements 120. Figure 40 shows six vacuum channels 1212, but as few as 1, 2, 3, 4, 5, and as many as 7, 8, 9, 10, or more to provide suction. Please understand that channels can be used.

0138In another skin shape configuration, it may be beneficial to first pinch and fold the patient's skin before delivering energy to the target tissue. After optimal administration (local or subcutaneous) of a local anesthetic such as lidocaine, the patient's skin can be grasped and partially separated so that the epidermis, dermis, and subcutaneous layer are separated from the underlying skeletal muscle. Once separated, the skin can be folded so that the proximity of the skin is adjacent to each other and the subcutaneous layer on one side of the fold faces the subcutaneous layer on the other side of the fold. Isolation of these adjacent subcutaneous layers provides a dense therapeutic area of target tissue and structure. FIG. 41 shows an example of a typical skin fold 148. The skin fold 148 has a top 149, two sides 150 (only one shown), two edges 151 (only one shown), and the longitudinal length of the fold. It comprises a "sandwiched" target tissue area 152 (ie, therapeutic area) along.

0139By concentrating the treatment on the target tissue-rich area within the skin fold 148, the two adjacent layers of the target tissue can be treated with a single treatment, enabling a more efficient procedure. In addition, the treatment can be administered from one or more orientations (eg, both sides of the fold 148), which can result in a more effective and reliable treatment. Also, because the skin is pulled away from the body, damage to important subcutaneous structures is minimized. In addition, the target tissue is farther from the blood supply, and the act of pinching or vacuuming the folded part 148 of the skin in place temporarily interrupts the blood supply to the folded tissue, so that the thermal conductivity of the blood flow There is little risk of collapse due to. In addition, the neural activity caused by the folding configuration on the skin may reduce the patient's pain sensation during treatment, based on the above-mentioned gate control theory of pain management.

0140In one embodiment, as illustrated in FIG. 42, the skin fold 148 is treated from the opposite side by an energy delivery device 153 with two energy delivery elements 154. The energy delivery element 154 is configured to deliver energy to the central therapeutic area 152 of the fold 148. For the energy delivery device 153, which comprises one or more microwave antennas connected to one or more microwave generators, the microwave energy traverses the outer epidermis layer from each side of the skin fold 148. It can penetrate deep into the therapeutic area 152. Optionally, a dielectric can be used in this treatment to optimize the delivery of microwave energy to the target tissue. As shown in FIG. 42, cooling element 115 can also be used on the skin surface to create a protected area 155 of non-target tissue. In addition, device 153 can be configured with cooling elements 115 and / or dielectric elements on either side of the skin folds 148 to stabilize the folds during treatment.

0141Alternatively, the embodiment illustrated in FIG. 42 can achieve a therapeutic effect by delivering RF energy instead of microwave energy. This energy delivery device comprises one or more electrodes on either or both sides of the skin fold. These electrodes are either in contact with the surface of the skin or in close proximity to the skin so as to deliver an electric field to the skin tissue. Each part of the skin tissue is resistance-heated by an electric field, and the peripheral part is conductively heated. One or more cooling elements, on either or both sides of the skin fold, can be used to cool the superficial non-target tissue conductively and / or by convection. .. Alternatively, the electrodes themselves can have cooling components such that they provide a cooling effect at the point of contact between the skin surface and the electrodes.

0142Figures 43A-43C are therapeutic devices using different energy sources (RF, microwave, and cold) configured to be inserted into or across the skin fold 148. Describe the three embodiments of. Minimally invasive insertion allows for more localized treatment of the target tissue so that the tissue into the non-target tissue is minimized. The device depicted in these figures is one or more needles, microneedles, stylets, or catheters for insertion into the epidermal layer of the skin fold so that the device reaches at least a portion of the therapeutic area 152. May include. Optionally, the device exits from the opposite side of the fold 148 so that the distal end of the device exits. It can be inserted on one side of the skin fold 148. The device may further be provided with one or more stabilizers on either side of the skin folds 148 to support each end of the inserted device. The stabilizer can optionally be provided with a cooling element to treat the epidermal tissue and create a protected non-target tissue area. The device can also be physically or electrically connected to an energy generator to supply the energy delivered to the target tissue.

0143FIG. 43A illustrates a minimally invasive RF delivery device 1245, including an RF generator 204 with one or more needles 207 for insertion into the skin fold. The needle 207 comprises one or more electrodes 206 that are strategically placed along the length of the needle 207 to optimize energy delivery and treatment to the target tissue 152. Alternatively, the needle 207 itself can be the electrode. To minimize treatment of non-target tissue, the portion 206 with the electrodes of each needle 207 can be insulated at the portion 205 that is not in close proximity to the target tissue 152. One or more cooling elements for the needle 207 to reduce the risk of marginal effects, carbonization, and / or drying, and the resulting loss of conductivity at or around the contacts between the electrode 206 and the tissue. Or the electrodes themselves can incorporate cooling components.

0144The embodiment depicted in FIG. 43B comprises a minimally invasive microwave delivery device 1213 comprising one or more microwave antennas 120 for insertion into a skin fold 148. The antenna 120 can be inserted adjacent to the target tissue 152 to maximize the delivery of microwave energy to the sweat glands within the therapeutic area 152. To optimize the delivery of microwave energy to the target tissue over the course of treatment, one or more antennas 120 of device 1213 may optionally be insulated with a dielectric material.

0145The embodiment depicted in FIG. 43C is a minimally invasive hypothermia comprising a cryotherapy source vessel 1244 and one or more needles, stylets, cannulas, or catheters for insertion into a skin fold 148. Equipped with device 1243. Stylet 211 is used to deliver cold fluid to target tissue 152 at a rate and volume sufficient to freeze, excise, and / or incapacitate one or more sweat glands within target tissue 152. It should have one or more passages and openings. Optionally, a heating element may be used to protect non-target tissue from disruptive or destructive damage. This heating element may be located as part of or along the stabilizer so as to treat the skin tissue from the surface of the skin. Alternatively, or in addition, the heating element may be located along the intervening portion of the device to provide protective heating to non-target tissue.

0146In the minimally invasive treatment illustrated in FIGS. 43A-43C, the energy delivery device is inserted across the skin fold 148 (eg, at right angles to the vertical axis of the fold). However, it should be understood that these devices can also be configured to be inserted through either edge and along the vertical axis of the wall. For example, as illustrated in FIG. 44, the energy delivery device 1214 is inserted through the edge 151 of the skin fold 148 and is shown aligned along the vertical axis of the fold 148. As shown in FIG. 44, the needle can optionally pierce the edge of the fold 148 opposite the insertion point. The energy delivery device 1214 comprises a needle having a heat conductive outer wall 1215 and an inner resistance heating element 1216. The power source (eg, battery, outlet, generator, etc.) delivers power to resistance heat the heating element and outer wall, thereby thermally treating the surrounding target tissue.

0147FIG. 45 illustrates another approach for minimally invasive treatment utilizing the skin fold structure. In this embodiment, the energy delivery element 209 is inserted through the top of the skin fold 148 so that it is located approximately in the center of the therapeutic area 152. This approach offers some advantages over other approaches in that the treatment is delivered directly to the surrounding target tissue 152, with minimal treatment to non-target tissue. As shown in FIGS. 46A and 46B, an array or row of unipolar electrode needles 207 can be used to deliver treatment along the longitudinal length of the skin fold. These elements can include insulator 205 at their proximal end to prevent unnecessary treatment of non-target tissue at the top of the skin folds. Alternatively, a row of bipolar electrode pairs 1206, 1207 can be used to deliver treatment that results in a consistent planar lesion within the target tissue.

0148FIGS. 47A-47B show variations of the embodiment illustrated in FIG. 45, depicting device insertion at the top of the skin fold 148. In this embodiment, a needle 207 with a hollow passage 1218 is first inserted into the top of the fold 148 through the superficial non-target tissue 103. Once the needle 207 is in place, the blunt dissociation electrode 1217 is inserted into the needle passage 1218 and driven through the target tissue 152. The blunt electrode 1217, when placed in the therapeutic area 152, can be activated to deliver an electric field to the therapeutic area to administer heat therapy. Optionally, the inserted hollow needle 207 can be insulated by insulator 1219 (as shown in FIG. 47B) to protect the non-target tissue 103 from the electric field.

0149The use of blunt electrodes may provide some advantages over those available with needle electrodes. First, blunt dissociation tends to follow the naturally occurring tissue plane that exists at the junction of the dermis and subcutaneous layers, whereas one or more needle embodiments dissociate any tissue within that pathway. In some cases. Therefore, blunt dissociation can facilitate accurate electrode placement. Second, the current density of the blunt electrode is more evenly distributed than that of the needle electrode. The current density of the needle electrode is concentrated on the sharp tip of the needle electrode so that the tissue in contact with the tip is heated and dried before a significant amount of energy can reach the surrounding tissue. Conversely, the current densities of the blunt electrodes are evenly distributed to allow for more consistent and predictable treatment.

0150Another embodiment utilizing the configuration of folded skin 148 is depicted in FIG. In this embodiment, one or more paddle elements 1221 are detachably connected to each outside of the skin fold 148 (eg, via an adhesive). The paddle element 1221 is operably coupled to a vibration source 1222, which drives the movement of the paddle 1221 in alternating order. The alternating movement of the paddle element 1221 creates friction between adjacent subcutaneous layers sandwiched within the skin fold, especially between the paddles on each side of the skin fold 148. Friction contact between adjacent subcutaneous layers is high because the sweat glands within these subcutaneous layers have a hard granular structure. The friction generated by the opposite movement of the subcutaneous layer mechanically deforms and damages these sweat glands, and is enough friction to neutralize or excise at least one sweat gland in the target tissue. It can also generate heat. The amount of frictional heat generated depends on a number of factors, including the speed and power of paddle movement, the frequency of paddle oscillation, the contact force between adjacent subcutaneous layers, and the adhesive force of the paddle element 1221 within the skin surface. To do.

0151In another embodiment that employs the shape of the skin fold, focused ultrasound can be used to focus and localize the treatment to the target tissue. As illustrated in FIG. 49, the ultrasound transducer 1223 can be used to deliver continuous ultrasound therapy from both sides of the skin fold 150 using one or more channels. The energy waves from each oscillator 1223 are graduated so that the waves from the first oscillator 1223 are in harmony with the waves from the other oscillators 1223 to produce a cumulative therapeutic effect in the target tissue area 152. obtain. The waves can also be synchronized to cancel each other out in areas where treatment is not desired (ie, non-target tissue 155). Therefore, optimal treatment includes oscillators that are configured and coordinated to deliver energy waves, which are additive in areas where the target tissue is dense, but subtractive in other areas. In this embodiment, the energy wave has a wave frequency of about 20kHz to 18MHz and about 0W / cm.2From about 50W / cm2It can be delivered with power in the range up to. More specifically, the treatment is at frequencies from about 0.5 MHz to about 3 MHz and about 720 mW / cm.2From about 50W / cm2It may be most effective with power up to.

0152Another embodiment utilizing ultrasonic energy and the shape of the skin folds is shown in Figure 50A. In this embodiment, the oscillator 1223 is located on one side 150 of the skin fold and instead of the oscillator 1223, a reflector 1224 is used on the other side 150 of the skin fold. As described above, the parameters of the remaining oscillator 1223 can be set so that the propagating wave reaches its peak amplitude when it reaches the therapeutic area 152 within the fold. In this embodiment, the frequency of the oscillator waves can be matched to the position and angle of the reflector 1224 on the opposite side of the 148 of the skin folds so as to generate a resonant frequency, by the reflector 1224. The waves reflected through the folds of the skin are virtually identical to the initial waves. Therefore, therapeutic area 152 accepts cumulative treatment despite the use of only one oscillator 1223. In addition, the use of reflector 1224 may provide the additional benefit of preventing ultrasound from moving away from the treatment site and damaging non-target structures elsewhere in the body.

0153Many skin treatments that use light energy cannot deliver maximum energy because the water in the skin tissue absorbs much of the energy. The embodiment illustrated in FIG. 50B provides a means for minimizing the water absorption of the delivered energy. In this embodiment, the light energy 1225 is configured to be delivered non-invasively to the therapeutic area 152 and absorbed by the target tissue 152 to produce a therapeutic effect. In some embodiments, near-infrared light is selected at wavelengths outside the peak of the highest water absorption frequency so that minimal light is absorbed by the blood and significant amounts of energy penetrate the therapeutic area. In one embodiment, energy can be delivered at wavelengths of about 1300 to 1600 nanometers. In another embodiment the energy wavelength can be from about 1400 to 1450 nanometers.

0154In one embodiment of the approach illustrated in FIG. 50B, light energy 1225 can be radiated from one energy source to the skin fold 148. The energy penetration associated with this treatment, and the resulting therapeutic effect, can be enhanced by increasing its spot size and optical fluence. In another embodiment, the light energy 1225 can be emitted from multiple sources concentrated in the therapeutic area 152, so that the energy from the multiple sources is focused on the therapeutic area 152. In addition to near infrared, some of the various energy types that can be employed in this configuration include, but are not limited to, infrared and IPL. The embodiment shown in FIG. 50B discloses the step of administering a light energy 152 treatment to the shape of the skin fold 148, but the treatment can also be given using a planar shape. One benefit of using a folded or pinched skin shape is that some of the blood in the microvasculature of the skin fold 148 is forced out of the fold tissue and the tissue It is to allow more light energy 1225 to pass through. This benefit is better in the presence of vacuum pressure, as shown in Figure 50B, as vacuum 147 facilitates the drainage of blood from the folds of the skin.

0155In the embodiments disclosed herein relating to the step of administering a thermal therapy that employs the shape of a skin fold, it may be desirable to thermally protect non-target tissue. Thermal protection can be particularly useful in this form, as protection can be applied to non-target tissue from both sides of the skin fold, as well as from the top of the skin fold. For example, for treatments in which an energy delivery device is configured to deliver heat energy to a target tissue in the treatment area, both sides of the fold and to limit the heat treatment to the target tissue and to protect the non-target tissue. A cooling element can be used at the top of the fold. The cooling element can also be incorporated into stabilizers on either side of the fold, which is used to maintain the fold during treatment.

0156As described for many of the embodiments discussed above, it may be desirable to use suction to create a skin fold. For example, the suction / vacuum cavity can be incorporated into any of the devices described above. FIG. 51 comprises a housing 156, a suction chamber 157, a vacuum port (not shown) for connection to a vacuum source (not shown), and an electrode 1227 connected to a power source by a lead 1228. The suction electrode 1226 is shown. The vacuum source can be configured to provide sufficient vacuum force to grip and support the skin in a folding orientation within the tissue chamber 157. The device may utilize suction 1226 to simply grip the skin at the beginning of the procedure or to hold the skin in place over part or all of the treatment. This area of lower pressure or suction within device 1226 helps to align the target tissue closer to the electrode antenna 1227 and adhere the device 1226 to the skin to reduce blood flow in the target tissue, thereby. Allows for more efficient heating of tissue.

0157In addition, aspiration helps control pain by inducing stretch and baroreceptors in the skin, thereby blocking the pain signal through the phylum control theory of pain management. The phylum control theory believes that excess neural signals arriving at the dorsal root ganglion of the spinal cord overwhelm the system, obscuring or blocking the transmission of pain receptor signals to the brain. This pain management mechanism is utilized by implantable electrical pain control units, TENS systems, Optilase systems, and others.

0158Figures 52A, 52B, and 52C illustrate alternative embodiments in which the clamp 1229 is used to generate the skin folds 148. As illustrated in FIG. 52A, a device 1230 with an insulating clamp 1229 and a conductive gold plate 1231 is used to deliver treatment to the skin folds 148. The metal plate 1231 is electrically connected to a power source for delivering energy to the target tissue within the skin fold 148. Optionally, a conductive gel can be used to ensure contact and proper delivery of energy to the target tissue. Alternatively, the embodiments depicted in FIGS. 52B and 52C show minimally invasive treatment, with skin folds 148 being maintained by stabilizers 1232 on both sides of the folds 148, while referenced to stabilizers 1232. The needle 207 is inserted through the top of the fold 148 to deliver treatment. The stabilizer 1233 of the embodiment of FIG. 52C is spring loaded with one or more springs 1234 to maintain the fold during treatment. Other non-limiting examples of tissue acquisition systems, devices, and methods described herein are, for example, previously incorporated by reference in their entirety, of US Provisional Application No. 61 / 045,937. It is disclosed on pages 69-71.

0159(iii. Strengthening) (1. Drug) In many of the treatments disclosed herein, the target tissue is damaged to produce a therapeutic effect. However, non-target tissues may also be affected in some of these treatments. Such treatments may have complications such as pain, inflammation, infections, and scarring that may occur both during and after treatment. Therefore, it may be beneficial to deliver the drug to the patient before, during, and / or after treatment to minimize the incidence and impact of these complications. Drugs that can be anesthetics for pain, steroids for inflammation, and antibiotics for infections can be administered orally, topically, or via local injection.

0160(2. Imaging) For any of the embodiments disclosed herein, it may be desirable to administer the treatment using medical imaging techniques. For example, ultrasound, magnetic resonance imaging (MRI), and light to locate, identify, and visualize target tissue before, during, and after treatment to optimize treatment efficacy. High resolution imaging such as coherence tomography (OCT) can be used. Alternatively, imaging can be used in combination with other diagnostic techniques to identify the target tissue for treatment or to determine the effectiveness of treatment. For example, iodine staining can be used to determine where the patient is sweating after treatment. 3. Controlled energy delivery by physiological feedback loop In some of the treatments disclosed herein to deliver energy to target tissue, controlled delivery of energy results in unnecessary damage to target and non-target tissues as a result of overheating. It may help to avoid (eg, drying, carbonization, etc.). Controlled delivery of energy may also result in a more consistent, predictable and efficient overall treatment. Therefore, it may be beneficial to incorporate a controller with programmed instructions to deliver energy to the tissue into the energy delivery system. In addition, these programmed instructions may include algorithms for automating controlled delivery of energy.

0161In embodiments that employ controlled delivery of energy, the controllers described above can be incorporated or coupled to the generator, where the generator follows a preset algorithm with temperature and / or power profile. To command. These profiles may define parameters that can be used to achieve the desired therapeutic effect in the target tissue. These parameters may include, but are not limited to, power and time increments, maximum permissible temperature, and ramp speed (ie, rate of temperature / power increase). Feedback signals with real-time or delayed physiological and diagnostic measurements can be used to modulate the overall delivery of these parameters and energy. Among the measurements that can be obtained, temperature, impedance, and / or reflected power at the treatment site and / or target tissue can be particularly useful. These measurements may help monitor the effect of energy delivery on the treatment site and target tissue over the course of treatment. The energy controller may have a fixed coefficient, or the coefficient of the controller may vary depending on the tissue response to energy delivery. In addition, algorithms with safety profiles may be employed to limit energy delivery or to limit perceived tissue temperature. These algorithms may stop or modulate energy delivery. In addition, in treatments that employ thermal protection, such as active cooling elements, protective cooling can be modulated based on monitored data.

0162By considering temperature readings in the delivery of energy, treatment can be administered to avoid unnecessary complications of treatment while achieving the required therapeutic effect. For example, energy delivery to the target tissue can be steadily increased (ie, increased at a constant rate) until the desired threshold temperature is reached for the target tissue, in order for the threshold temperature to produce a therapeutic effect. The required temperature. By increasing power or stopping the delivery of energy altogether, once the threshold temperature is reached, harm to non-target tissue due to additional and excessive heating can be avoided.

0163Temperature can be measured using any number of sensors, including thermocouples and thermistors, such sensors that can be incorporated into energy delivery elements, energy delivery devices, and / or energy delivery systems. .. For example, in an RF energy delivery system, the thermocouple may be embedded in an electrode that delivers RF energy, placed adjacent to the electrode as part of an energy delivery device, or the thermocouple may be wired directly to the generator. Can be located away from the device. The temperature measured can be the temperature of tissue directly adjacent to the device, target tissue, or any other tissue that may provide useful temperature measurements. If the energy delivery element is thermally connected to the surrounding tissue (eg, via conduction), the sensor incorporated into the energy delivery element may measure the temperature of the element itself.

0164Impedance can be measured by observing the response of the tissue to electrical stimulation. This measurement is useful because it can help assess the degree of energy delivery to and through the tissue. For example, energy directed to a tissue with high impedance can be difficult to penetrate deeper into the tissue. This is especially important in the case of skin tissue, as the impedance of the skin can change over the course of treatment. As the tissue is heated, it loses water, its conductivity decreases, and its impedance increases. If the tissue is heated to dryness, the resistance of the tissue may impair the delivery of energy to the surrounding tissue via electrical conduction. By adopting impedance measurement feedback in the energy delivery system, it is possible to optimize the delivery of energy to the target tissue while avoiding adverse effects on the target and non-target tissues.

0165FIG. 53 shows another embodiment for the controlled delivery of energy to the target tissue. In this embodiment, the electrode array 1235 can be configured to be continuously activated as adjacent bipolar pairs (eg, 1236, 1237). For example, in the first activation, the first electrode 1236 is the anode and the second electrode 1237 is the cathode. In the second activation, the second electrode 1237 functions as an anode and the third electrode 1238 is a cathode. Therefore, the first electrode 1236 and the second electrode 1237, the second electrode 1237 and the third electrode 1238, the third electrode 238 and the fourth electrode 1239, and the fourth electrode 1239 and the fifth electrode 1240 A therapeutic effect can be achieved with. In addition, since only one electrode pair is activated at a time, each treatment in that order can be customized based on the characteristics of the tissue being treated. For example, if the impedance between the first electrode 1236 and the second electrode 1237 is higher than the impedance between the second electrode 1237 and the third electrode 1238, the first treatment is a second treatment. It may be applied over a longer duration than treatment. This results in higher resolution per activation and more accurate overall treatment.

0166(4. Step-by-step treatment) For many of the treatments disclosed herein, it may be desirable to provide treatment in stages. In addition, treatment can be patterned such that the target tissue is treated in the early stages while the other parts are treated in later stages. For example, as illustrated in FIG. 54, the patient has an area marked "A" that is treated in the first stage and an area marked "B" that is treated in the second stage. Can have. In addition, it can be differentiated into further stages and additional areas. Optionally, the treatment can be administered to the same region at multiple stages so that each region receives the treatment multiple times. In one embodiment, in subsequent stages, treatment of a particular area may vary, with increased or decreased amounts of energy, different types of treatment, and the like.

0167This approach has a number of potential benefits. First, step-by-step treatment provides the body with a healing opportunity between treatments. This is because the steps to treat or heat-damage tissue discontinuities over several sessions are less and less severe than the steps to treat or heat-damage relatively larger tissue areas in one session. It is especially important because it may have non-complications. Second, patterned treatment with a small therapeutic area elicits a more favorable healing response. Healing time is related to the distance that fibroblasts must travel from the surrounding tissue, so smaller therapeutic areas heal much faster than larger therapeutic areas. Figures 55A-E illustrate examples of various patterned treatments.

0168For healthcare practitioners, step-by-step, patterned treatment may provide the opportunity to track the effectiveness of the treatment and provide follow-up treatment tailored to the specific needs of the patient. For example, in the treatment of axillary hyperhidrosis, sweating is mapped so that the clinician (1) identifies the remaining treatment area and (2) determines the overall reduction in sweating in the area under the axilla. Can have a follow-up session (eg, iodine staining). For patients who do not necessarily desire 100% anhidrosis, stepwise treatment may allow treatment to be discontinued at a particular point in time. For example, a patient suffering from a severe case of axillary hyperhidrosis may be satisfied with a 70% reduction in sweating and only wants to participate in the number of treatments required for such reduction. There is.

0169In addition, step-by-step, patterned treatment can minimize the body's contracture response during the healing process. In a process called fibrosis (or scarring), fibroblasts lie down the collagen network to promote tissue healing. As the scar density increases, the treated area contracts, thereby tightening the skin within that area. In the treatment of axillary hyperhidrosis, contractures can potentially impair the total range of motion of the patient's arm. Treatment can be patterned and staged to minimize contracture and / or its effect on the patient. For example, the narrow therapeutic area depicted in Figure 55C results in minimal axillary contracture and consequent dysfunction for arm range of motion.

0170Templates can be used to facilitate the application of stepwise and / or patterned treatments. FIG. 56 illustrates a series of stepwise treatments with three templates 158, 159, 160, each template configured to allow treatment of different parts of the overall treatment area. Templates may be configured to engage an energy delivery device or one or more energy delivery elements to facilitate the application of stepwise and / or patterned treatments. The template can consist of a single frame, made of wood, plastic, or metal, with removable or adjustable parts to reflect the desired pattern and / or stage. As an alternative, the template also uses a temporary marker, tatu, or dye (eg, henna) that remains over the course of multiple stepwise treatments to create one or more patterns that are drawn on the patient's skin. Can also be.

0171In another embodiment, as illustrated in FIG. 57, the template pattern can be represented by different chromophores 1246, 1247, 1248, which correspond to different stages of treatment. For example, different chromophores 1246, 1247, 1248 are injected into the patient's skin so that each chromophore 1246, 1247, 1248 and the region 1241 colored by such chromophores correspond to one treatment step. be able to. Once all areas are properly colored, laser treatment can be initiated. At each stage of treatment, the treatment area is irradiated with different lasers, and the wavelength of each laser is specifically matched to the absorption characteristics of the different chromophore regions.

0172In another application that employs the color coordination template described above, an energy delivery device, energy applicator, or energy delivery element may comprise this template. For example, in the microneedle configuration that retains its original shape, as shown in FIG. 16, the chromophore tip microneedle patch 239 can be configured with selective colors according to the color coordination template described above. The same patch can be used at each treatment stage and different treatments are administered by irradiating the patch with lasers of different wavelengths.

0173(5. Diagnosis) Embodiments of the present invention also include methods and devices for identifying and diagnosing patients with hyperhidrosis. Such a diagnosis can be made based on subjective patient data (eg, the patient's response to an observed sweating question) or an objective test. In one embodiment of the objective test, the iodine solution can be applied to the patient to identify where on the surface of the skin the patient is sweating and not sweating. For example, US Pat. No. 4,190,056 of Tapper et al., Incorporated herein by reference in its entirety, describes methods and means for recording sweat gland activity. Also, a particular patient can be diagnosed based on excessive sweating in different parts of the body to specifically identify which area is being treated. Thus, treatment may be selectively applied to different parts of the body in need of treatment, including, for example, hands, armpits, feet, and / or face.

0174(6. Quantification of successful treatment) After completion of any of the above treatments, or any stage of treatment, success can be qualitatively assessed by the patient or may be quantitatively assessed by any number of methods. For example, the number of disabled or destroyed sweat glands per treated surface area can be measured. Such an assessment is performed by imaging the treated area or by determining the amount of treatment administered to the treated area (eg, the amount of energy delivered, the measured temperature of the target tissue, etc.). It can be done. The iodine solution test described above may also be employed to determine the extent of therapeutic effect. In addition, treatment can be initiated or modified so that the amount of sweating experienced by the patient may be reduced by a desired rate compared to pretreatment under defined laboratory criteria. For example, especially for patients diagnosed with severe hyperhidrosis, the amount of sweating is about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, Or it may be further reduced. For patients diagnosed with a less severe or more normal sweating profile, a gradual reduction in sweating may be achieved, but with low resolution. For example, such patients may only be able to achieve partial anhidrosis in units of 25%.

0175(Overview of certain methods, systems, and other embodiments) In one embodiment, the present specification is a step of identifying a patient with symptoms of excessive sweating, wherein the patient desires to reduce sweating in at least a portion of the patient's body. The step of placing an energy delivery device in close proximity to the skin tissue and the step of delivering enough energy to the patient's sweat glands to stop sweat production by at least partially disabling or destroying the sweat glands. Provide methods related to the steps of treating a patient, including.

0176In some embodiments, the step of arranging the energy delivery device is further selected from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, low temperature probes, and combinations thereof. May include the step of placing the laser in close proximity to the patient's skin tissue. In one embodiment, the steps of delivering energy to the patient's sweat glands are further electromagnetic, X-ray, radio frequency, microwave, ultrasonic, near infrared, infrared, ultrashort pulsed light, visible light, and laser, and their It may include the step of delivering energy to the sweat glands, selected from the group consisting of combinations. The step of delivering energy to the sweat glands may further include the step of heating the sweat glands, and the step of heating the sweat glands may further include the step of removing the sweat glands at least partially.

0177In one embodiment, the step of placing the energy delivery device may further include the step of inserting the energy delivery device into the skin tissue. In one embodiment, the step of inserting the energy delivery device into the skin tissue may further include inserting the energy delivery device into the skin tissue to a depth ranging from about 1 mm to about 8 mm below the surface of the skin. .. The step of inserting the energy delivery device into the skin tissue may further include inserting an intervening device selected from the group consisting of needles, stylets, catheters, probes, and microneedles into the skin tissue.

0178In one embodiment, the method may further include the step of providing protective cooling to the skin tissue. The step of providing protective cooling to the skin tissue may further include the step of placing a cooling element in close proximity to the skin tissue.

0179In one embodiment, the method may further include administering to the patient a drug selected from the group consisting of anesthetics, steroids, and antibiotics. The step of administering the drug to the patient may further include the step of administering the drug orally, topically or via injection.

0180In one embodiment, the method may further include the step of visualizing the sweat glands using medical imaging.

0181In one embodiment, the method may further include the step of monitoring diagnostic parameters of skin tissue. Diagnostic parameters may be selected from the group consisting of impedance, temperature, reflected light, and reflected power.

0182In one embodiment, the step of delivering energy to the patient's sweat glands may further include the step of modulating the energy delivery according to the monitored diagnostic parameters.

0183In one embodiment, the method may further include the steps of reducing sweating achieved in the patient or quantifying the treated portion of the patient's body.

0184According to the method, the patient may wish to reduce sweat on at least a portion of the patient's body, including at least a portion of the patient's axilla.

0185In one embodiment, the method may further include the step of raising the skin tissue away from the underlying tissue before delivering energy to the sweat glands.

0186In one embodiment, a step of identifying a skin tissue region on a patient having a sweat gland layer, the skin tissue region producing excess sweat for hyperhidrosis, a step, a first aspect, and a second. The step of grasping the skin tissue area so as to form a fold of the skin, which comprises the sides of the sweat gland layer corresponding to the first side, so that the layer comprises a therapeutic area. Adjacent to the sweat gland layer corresponding to the aspect of, and the step of delivering energy to the therapeutic area to produce a therapeutic effect, the therapeutic effect reducing the amount of sweating from the skin tissue area. Methods related to the steps of treating a patient for the symptoms of hyperhidrosis, including and, are provided.

0187In one embodiment, the method may further include applying protective cooling to at least a portion of the skin tissue.

0188In one embodiment, the step of applying protective cooling to at least a portion of the skin tissue area may further include placing a cooling element in close proximity to the skin fold. The step of placing the cooling element close to the skin fold is further a first cooling element close to the first side of the skin fold and a second close to the second side of the skin fold. May include the step of arranging the cooling elements of.

0189In one embodiment, the step of gripping the skin tissue area to form a fold of the skin may further include the step of providing suction to the skin tissue area. The step of providing suction to the skin tissue area may further include the step of maintaining suction to the skin tissue area during treatment.

0190In one embodiment, a step of elevating the skin tissue of a patient, wherein the skin tissue comprises a target tissue comprising at least one sweat gland, and a step of delivering energy to the target tissue of the energy. Delivery provides methods relating to steps to reduce a patient's sweating, including a step of at least partially disabling or destroying at least one sweat gland so as to reduce sweating from the patient's skin tissue. To.

0191In one embodiment, the step of delivering energy to the target tissue may further include the step of placing the energy delivery device in close proximity to the patient's skin tissue. In one embodiment, the step of arranging the energy delivery device further comprises an energy delivery element selected from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, low temperature probes, and combinations thereof. , May include the step of placing in close proximity to the patient's skin tissue. In another embodiment, the step of placing the energy delivery device may further include the step of inserting the energy delivery device into the skin tissue. The step of inserting the energy delivery device into the skin tissue may further include the step of placing the insertion element energy delivery element in close proximity to the target tissue.

0192In one embodiment, the energy delivery element may be selected from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, and combinations thereof.

0193In one embodiment, the step of raising the skin tissue may further include the step of imparting suction to the skin tissue.

0194In one embodiment, the method may further include the step of providing protective cooling to the skin tissue. The step of providing protective cooling to the skin tissue may further include the step of placing a cooling element in close proximity to the skin tissue.

0195In one embodiment, the step of delivering energy to the target tissue further comprises delivering the energy to the first part of the target tissue the first time and the energy to the second part of the target tissue a second time. It may be. The first and second times may be separated by a predetermined period. The predetermined period may be selected from the group consisting of 1 to 7 days, 1 to 4 weeks, and 1 to 4 months.

0196In one embodiment, an energy delivery device comprising an energy generator and an energy delivery device configured for placement in close proximity to the patient's skin tissue is provided, the device relating to the step of treating the sweat glands of the patient. Is coupled to an energy generator so that the energy delivery device delivers sufficient energy to the target tissue within the skin tissue to at least partially destroy or disable at least one sweat gland within the target tissue. It is composed.

0197In some embodiments, the energy delivery device may be configured for insertion into target tissue.

0198In some embodiments, the energy delivery device comprises at least one energy delivery element selected from the group consisting of electrodes, antennas, ultrasonic transducers, lasers, light emitting diodes, light bulbs, low temperature probes, and combinations thereof. You may prepare.

0199In one embodiment, the first device may further include a cooling element configured for installation in close proximity to the patient's non-target tissue.

0200In one embodiment, the first device may further include a suction device configured for placement in close proximity to the patient's skin tissue.

0201In one embodiment, the application comprises an intervening device comprising at least one needle configured for insertion in close proximity to the patient's target tissue and a light energy configured to transfer light energy to the intervening device. Provided with a source, a second device involved in the step of treating a patient's target tissue, the needle is configured to receive the light energy transmitted by the light energy source.

0202In one embodiment, the chromophore may generate thermal energy from the light energy absorbed from the light energy source. The chromophore may generate thermal energy from the light energy absorbed from the light energy source. Thermal energy from the chromophore may cause a therapeutic effect on the target tissue. In one embodiment, the therapeutic effect on the target tissue may include the step of heating the target tissue. In another embodiment, the therapeutic effect on the target tissue may include the step of removing the target tissue at least partially. In yet another embodiment, the therapeutic effect on the target tissue comprises at least partially disabling at least one target structure selected from the group consisting of sweat glands, hair follicles, sebaceous glands, collagen, and fat. But it may be.

0203In one embodiment, the intervening device may further include a microneedle patch with an optically neutral backing.

0204Unless the context explicitly requires otherwise, throughout the description and claims, terms such as "provide," "provide," and equivalent are implied, as opposed to their exclusive or inclusive meaning. In other words, it is interpreted in the sense that "including, but not limited to,". Words that use the singular or plural also include the plural or singular, respectively. When a claim uses the word "or" to refer to a list of two or more items, the word is any of the items in the list, all items in the list, and any of the items in the list. It covers all interpretations of words, such as combinations.

0205The above detailed description of embodiments of the invention is not intended to be comprehensive or to limit the invention to the exact embodiments disclosed above. Specific embodiments and examples of the present invention have been described above for illustrative purposes, but as will be appreciated by those skilled in the art, various equivalent modifications are possible within the scope of the present invention. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order.

0206The various embodiments described herein may also be combined to provide additional embodiments. Further details about related methods, devices, and systems that utilize microwaves and other therapies, including other forms of electromagnetic radiation, and the treatments that may be performed by such therapies, are prioritized in the present application. Requested, "Methods, Delivery and Systems for Non," filed April 19, 2007, "Methods, Delivery and Systems for Non," filed December 12, 2007, US Provisional Patent Application No. 60 / 912,889 -US Provisional Patent Application No. 61 / 013,274 entitled "Invasive Delivery of Microwave Therapy", filed April 17, 2008, "Systems and Methods for Creating an" Effect Using Microwave Energy in Specified It is described in the provisional applications referenced above, such as US Provisional Patent Application No. 61 / 045,937 entitled "Tissue", the entire of which is incorporated herein by reference. The applications described above may be incorporated by reference to a particular subject matter, as described herein above, but the applicants may include any of the disclosures of the application incorporated by these references. It is intended to be incorporated herein by reference in its entirety, in that all or all may be combined and incorporated with embodiments described herein.

0207Generally, the terms used in the following claims are to be construed as limiting the invention to the specific embodiments disclosed herein, unless the detailed description above explicitly defines such terms. Should not be. Some aspects of the invention are presented below in certain forms of claim, but the inventors consider various aspects of the invention in any number of forms of claim. Accordingly, we reserve the right to add such additional claims after filing an application in order to pursue additional claims for other aspects of the invention.

0208(Additional reference material for incorporation) The following references describe methods, devices, and other embodiments that may be incorporated into or used in combination with the embodiments described herein. Each of these references is incorporated herein by reference in its entirety.

0209Pressure-Induced Bullae and Sweat Gland Necrosis Following Chemotherapy Induction, The American Journal of Medicine (September 15, 2004, Volume 117). US Patent No.5,190,518 to Takasu titled Surgical Device for the Treatment of Hyper Hidrosis. US Patent No.4,190,056 to Tapper et al.titled Method and Means for Recording Sweat Gland Activity. US Patent No.6,050,990 to Tankovich et al. titled Methods and Devices for Inhbiting Hair Growth and Related Skin Treatments. A comparative study of the surgical treatment of axillary osmidrosis by instrument, manual and combined subcutaneous shaving procedures, Park et al., Annals of Plastic Surgery, Volume 41, November 1998, pg.488-497. Electrosurgery Using Insulated Needles: Treatment of Axillary Bromhidrosis and Hyperhidrosis by Kobayashi, Journal of Dermatological Surgery and Oncology, July 1988, pg. 749-752. Selective sweat gland removal with minimal skin excision in the treatment of axillary hyperhidrosis: a retrospective clinical and histological review of 15 patients by Lawrence et al., British Journal of Dermatology, 2006, pg.115-118. US Patent Application Publication No.US 2006/0111744 to Makin et al.titled Method and System for Treatment of Sweat Glands. US Patent Application Publication No.US 2003/0158566 to Brett titled Percutaneous Cellulite Removal System.

Citations
Document	Relation	Office
JP2006289098A	Cites	Japan
US2006111744A1	Cites	United States of America

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US2008269851A1	United States of America	A1	2008-10-30
WO2008131302A2	World Intellectual Property Organization (WIPO)	A2	2008-10-30
WO2008131306A1	World Intellectual Property Organization (WIPO)	A1	2008-10-30
AU2008335715A1	Australia	A1	2009-06-18
CA2708765A1	Canada	A1	2009-06-18
WO2009075879A1	World Intellectual Property Organization (WIPO)	A1	2009-06-18
WO2009075903A1	World Intellectual Property Organization (WIPO)	A1	2009-06-18
WO2009075904A1	World Intellectual Property Organization (WIPO)	A1	2009-06-18
WO2009128940A1	World Intellectual Property Organization (WIPO)	A1	2009-10-22
WO2008131302A3	World Intellectual Property Organization (WIPO)	A3	2009-12-30
EP2142125A1	European Patent Office (EPO)	A1	2010-01-13
EP2142128A1	European Patent Office (EPO)	A1	2010-01-13
EP2142129A2	European Patent Office (EPO)	A2	2010-01-13
US2010049178A1	United States of America	A1	2010-02-25
AU2009308088A1	Australia	A1	2010-04-29
CA2741109A1	Canada	A1	2010-04-29
CA3038950A1	Canada	A1	2010-04-29
WO2010047818A1	World Intellectual Property Organization (WIPO)	A1	2010-04-29
US2010114086A1	United States of America	A1	2010-05-06
CN101711134A	China	A	2010-05-19
JP2010524587A	Japan	A	2010-07-22
JP2010524589A	Japan	A	2010-07-22
JP2010524591A	Japan	A	2010-07-22
WO2009075879A8	World Intellectual Property Organization (WIPO)	A8	2010-07-22
US2010211059A1	United States of America	A1	2010-08-19
WO2010096840A2	World Intellectual Property Organization (WIPO)	A2	2010-08-26
EP2231274A1	European Patent Office (EPO)	A1	2010-09-29
KR20100105669A	Republic of Korea	A	2010-09-29
US2010268220A1	United States of America	A1	2010-10-21
MX2010006363A	Mexico	A	2010-10-26
EP2271276A1	European Patent Office (EPO)	A1	2011-01-12
WO2010096840A3	World Intellectual Property Organization (WIPO)	A3	2011-01-20
CN101970046A	China	A	2011-02-09
US2011040299A1	United States of America	A1	2011-02-17
JP2011505969A	Japan	A	2011-03-03
EP2231274A4	European Patent Office (EPO)	A4	2011-04-06
USD636054S	United States of America	S	2011-04-12
EP2142125A4	European Patent Office (EPO)	A4	2011-04-20
EP2142128A4	European Patent Office (EPO)	A4	2011-04-20
EP2142129A4	European Patent Office (EPO)	A4	2011-04-20
RU2009142599A	Russian Federation	A	2011-05-27
JP2011517992A	Japan	A	2011-06-23
KR20110086831A	Republic of Korea	A	2011-08-01
EP2349167A1	European Patent Office (EPO)	A1	2011-08-03
US2011196365A1	United States of America	A1	2011-08-11
HK1148492A	Hong Kong, China	A	2011-09-09
HK1148492A1	Hong Kong, China	A1	2011-09-09
US2011313412A1	United States of America	A1	2011-12-22
US2012010609A1	United States of America	A1	2012-01-12
US2012022622A1	United States of America	A1	2012-01-26
JP2012506293A	Japan	A	2012-03-15
EP2532320A2	European Patent Office (EPO)	A2	2012-12-12
EP2271276A4	European Patent Office (EPO)	A4	2013-01-23
SG186642A1	Singapore	A1	2013-01-30
EP2349167A4	European Patent Office (EPO)	A4	2013-02-27
US8401668B2	United States of America	B2	2013-03-19
US8406894B2	United States of America	B2	2013-03-26
EP2532320A3	European Patent Office (EPO)	A3	2013-04-03
US2013150844A1	United States of America	A1	2013-06-13
US2013166003A1	United States of America	A1	2013-06-27
JP2013173022A	Japan	A	2013-09-05
JP2013176628A	Japan	A	2013-09-09
AU2008335715B2	Australia	B2	2014-01-23
JP2014014721A	Japan	A	2014-01-30
EP2142125B1	European Patent Office (EPO)	B1	2014-03-05
EP2231274B1	European Patent Office (EPO)	B1	2014-03-12
US8688228B2	United States of America	B2	2014-04-01
US2014180271A1	United States of America	A1	2014-06-26
ES2471971T3	Spain	T3	2014-06-27
JP5543332B2	Japan	B2	2014-07-09
JP5545668B2	Japan	B2	2014-07-09
RU2523620C2	Russian Federation	C2	2014-07-20
EP2142128B1	European Patent Office (EPO)	B1	2014-08-06
EP2762199A1	European Patent Office (EPO)	A1	2014-08-06
EP2767308A1	European Patent Office (EPO)	A1	2014-08-20
ES2488565T3	Spain	T3	2014-08-27
US8825176B2	United States of America	B2	2014-09-02
JP2014184317A	Japan	A	2014-10-02
JP2014184319A	Japan	A	2014-10-02
ES2522299T3	Spain	T3	2014-11-14
EP2837351A1	European Patent Office (EPO)	A1	2015-02-18
CN101970046B	China	B	2015-03-25
BRPI0810066A2	Brazil	A2	2015-05-05
US2015148792A1	United States of America	A1	2015-05-28
BRPI0820706A2	Brazil	A2	2015-06-16
CN104707263A	China	A	2015-06-17
JP2015134233A	Japan	A	2015-07-27
EP2349167B1	European Patent Office (EPO)	B1	2015-08-05
EP2907465A1	European Patent Office (EPO)	A1	2015-08-19
JP5781122B2	Japan	B2	2015-09-16
EP2349167B8	European Patent Office (EPO)	B8	2015-09-30
US9149331B2	United States of America	B2	2015-10-06
JP5827291B2	Japan	B2	2015-12-02
US2015351838A1	United States of America	A1	2015-12-10
US9241763B2	United States of America	B2	2016-01-26
HK1207277A	Hong Kong, China	A	2016-01-29
HK1207277A1	Hong Kong, China	A1	2016-01-29
EP2767308B1	European Patent Office (EPO)	B1	2016-04-13
JP5909522B2	Japan	B2	2016-04-26
US2016135888A1	United States of America	A1	2016-05-19

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