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Title:
APPARATUS FOR THE TEMPORARY TREATMENT OF HYPERHIDROSIS
Document Type and Number:
WIPO Patent Application WO/2014/135511
Kind Code:
A1
Abstract:
The technology provided herein relates to medical systems, methods novel use of low electromagnetic or ultrasound energy for to the temporary treatment of hyperhidrosis. In particular, the present application relates to methods and apparatuses for reducing the temporary sweat production via the temporary removal, disablement, incapacitation of apocrine and eccrine glands in the dermal and subcutaneous tissue.

Inventors:
FATEMI AFSCHIN (DE)
Application Number:
PCT/EP2014/054113
Publication Date:
September 12, 2014
Filing Date:
March 04, 2014
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
FATEMI AFSCHIN (DE)
International Classes:
A61N7/00; A61B18/14; A61N1/40; A61N5/06; A61B18/00
Domestic Patent References:
WO2009147617A12009-12-10
WO2006089227A22006-08-24
WO2007015247A22007-02-08
WO2012072250A12012-06-07
WO2009149390A12009-12-10
Foreign References:
US6241753B12001-06-05
US6311090B12001-10-30
US6350276B12002-02-26
US6377855B12002-04-23
US6381497B12002-04-30
US6381498B12002-04-30
US6387380B12002-05-14
US6425912B12002-07-30
US6405090B12002-06-11
US6453202B12002-09-17
US7022121B22006-04-04
US7258674B22007-08-21
US7841984B22010-11-30
Attorney, Agent or Firm:
ROTH, Andy Stefan (Düsseldorf, DE)
Download PDF:
Claims:
CLAIMS

1. A medical electromagnetic energy system suitable for the temporary reduction of sweating, comprising an electromagnetic energy emitter coupled to an electromagnetic energy source, wherein the electromagnetic energy source delivers thermal energy between 25 and 50 J/cm2 via the electromagnetic energy emitter through the skin surface to a sweat glands containing tissue site, wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited.

2. The system according to claim 1, wherein the electromagnetic energy emitter is a radiofrequency (RF) electrode coupled to an RF energy source as the electromagnetic energy source for nonablative capacitive radiofrequency radiation.

3. The system according to claim 2, further comprising a source of electrolytic solution that delivers electrolytic solution to the RF electrode.

4. The system according to claim 3, wherein RF energy is transferred from the RF electrodes to the electrolytic solution.

5. The system according to any one of claims 1 to 4, wherein the delivered electromagnetic energy is between 30 to 40 J/cm2, in particular 35 J/cm2.

6. A medical ultrasound energy system suitable for the temporary reduction of sweating, comprising an ultrasound energy emitter coupled to an ultrasound energy source, wherein the ultrasound energy source delivers ultrasound energy between 40 to 60 J/cm2 via the ultrasound energy emitter through the skin surface to a sweat glands containing tissue site, wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited.

7. The system according to claim 6, wherein the delivered ultrasound energy is between 45 to 55 J/cm2, in particular 47 J/cm2

8. A method for the non-invasively temporary treatment of hyperhidrosis and/or normohydrosis by exposing an area of skin tissue comprising a layer of sweat glands to an electromagnetic energy, whereby the electromagnetic energy is delivered from an electromagnetic energy source through the skin surface to the sweat glands containing tissue site, and wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site during the treatment; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited.

9. The method according to claim 8, wherein the electromagnetic energy source is an electrode means for delivering thermal energy.

10. The method according to any one of claims 8 to 9, wherein the delivered electromagnetic energy is between 25 and 50 J/cm2, in particular 30 to 40 J/cm2, more particular 35 J/cm2.

11. The method according to any one of claims 8 to 10, wherein the electrode means is a radiofrequency (RF) electrode coupled to an RF energy source for nonablative capacitive radiofrequency radiation.

12. The method according to claim 11, further comprising a source of electrolytic solution that delivers electrolytic solution to the RF electrode.

13. The method according to claim 12, wherein RF energy is transferred from the RF electrodes to the electrolytic solution.

14. The method according to any one of claims 8 to 13, wherein the RF energy has a frequency between 6 and 8 Mhz, in particular between 6,5 and 7,5 Mhz, in particular between 6,6 and 6,8 Mhz, in particular a frequency of 6.78Mhz.

15. The method according to any one of claims 15 to 18, wherein the RF energy has power output up to 500W, preferably up to 400W.

16. The method according to any one of claims 8 to 15, wherein an internally cooled treatment tip is used.

17. A method for the non-invasively temporary treatment of sweating due to hyperhidrosis and/or normohydrosis by exposing an area of skin tissue comprising a layer of sweat glands to an ultrasound energy, whereby the ultrasound energy is delivered from an ultrasound energy source through the skin surface to the sweat glands containing tissue site, and wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site during the treatment; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited.

18. The method according to claim 17, wherein the ultrasound emitter emits ultrasound energy between 40 to 60 J/cm2, in particular 45 to 55 J/cm2, more particular 47 J/cm2.

19. The method according to any one of claims 17 to 18, wherein the hyperhidrosis is focal hyperhidrosis.

20. The method according to any one of claims 17 to 19, wherein the method is cosmetic method.

21. Use of electromagnetic or ultrasound energy for the temporary reduction of sweat

glands, wherein:

a) an electromagnetic or ultrasound energy source is provided;

b) energy is delivered from the energy source through the skin surface to the sweat glands containing tissue site, wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site; and

c) the sweat glands are reduced or temporarily inhibited or their innervation is

temporarily inhibited.

22. Use according to claim 26, wherein the electromagnetic energy source is an electrode means for delivering thermal energy.

23. Use according to claim 27, wherein the electrode means is a radiofrequency (RF)

electrode coupled to an RF energy source for nonablative capacitive radiofrequency radiation.

24. Use according to claim 28, further comprising a source of electrolytic solution that

delivers electrolytic solution to the RF electrode.

25. Use according to claim 29, wherein RF energy is transferred from the RF electrodes to the electrolytic solution.

26. Use according to any of claims 23 to 25, wherein the RF energy is between 25 and 50 J/cm2, in particular 30 to 40 J/cm2, more particular 35 J/cm2.

27. Use according to claim 21, wherein the ultrasound energy source is an ultrasound

emitter coupled to an ultrasound energy source.

28. Use according to claim 27, wherein the ultrasound emitter emits ultrasound energy between 40 to 60 J/cm2, in particular 45 to 55 J/cm2, more particular 47 J/cm2.

29. Use according to any of claims 26 to 40, wherein the hyperhidrosis is focal

hyperhidrosis.

30. A method for reducing sweat glands in a selected sweat glands containing tissue site beneath an epidermis skin surface, comprising: a) providing an electromagnetic or ultrasound energy source with an energy delivery surface; b) positioning the energy delivery surface on the epidermis skin surface; c) creating an uniform reverse thermal gradient through the skin epidermis surface where a temperature of the skin epidermis surface is lower than the selected sweat glands containing tissue site; and d) delivering energy from the energy source through the skin epidermis surface to the selected sweat glands containing tissue site for a sufficient time to reduce a plurality of sweat glands in the selected sweat glands containing tissue site.

31. The method according to claim 30, wherein the epidermis skin surface is cooled at least one of before, during or after delivering the energy.

32. The method according to any one of claims 30 to 31, wherein the electromagnetic energy source is a radiofrequency (RF) energy source.

33. The method according to claim 32, wherein a radiofrequency (RF) electrode is coupled to the RF source for nonablative capacitive radiofrequency radiation.

34. The method according to claim 33, further comprising a source of electrolytic solution that delivers electrolytic solution to the RF electrode.

35. The method according to claim 34, wherein RF energy is transferred from the RF electrodes to the electrolytic solution.

36. The method according to any one of claims 32 to 35, wherein an internally cooled treatment tip for applying the RF energy to the sweat glands containing tissue site beneath an epidermis skin surface is used.

37. The method according to any one of claims 30 to 36, wherein the delivered electromagnetic energy from the energy source through the skin epidermis surface has an energy between 25 and 50 J/cm2, in particular 30 to 40 J/cm2, more particular 35 J/cm2.

38. The method of claim 30 wherein the delivered ultrasound energy from the energy source through the skin epidermis surface has an energy between 40 to 60 J/cm2, in particular 45 to 55 J/cm2, more particular 47 J/cm2.

39. The method according to any one of claims 30 to 31, wherein an ultrasound emitter is coupled to the ultrasound energy source.

40. The method according to any one of claims 30 to 39, wherein the skin surface is cooled with a gel sheet.

Description:
Duesseldorf, March 4, 2013 Dr.med. Afschin Fatemi, Duesseldorf, Germany

APPARATUS FOR THE TEMPORARY TREATMENT OF HYPERHIDROSIS

FIELD OF THE DISCLOSURE

[0001] The technology provided herein relates to medical systems, methods novel use of electromagnetic or ultrasound energy for to the temporary treatment of hyperhidrosis. In particular, the present application relates to methods and apparatuses for reducing the temporary sweat production via the temporary removal, disablement, incapacitation of apocrine and eccrine glands in the dermal and subcutaneous tissue.

[0002] BACKGROUND

[0003] Focal hyperhidrosis is an entity, in which patients sweat excessively in selected areas of the body, most commonly axillae, palms or feet. Patients sweat in general more than 30mg/min, independent of external or internal temperatures.

[0004] Focal hyperhidrosis can be followed by other diseases such as intertrigo, mycosis, bacterial infection, erythema, pigmentation, bromhidrosis, general infection or cold.

[0005] Treatment options include topical aluminum chloride or iontopheresis, which are both not very effective and are accompanied by discomfort. Same as with not so effective systemic medications, there is an injections of botulinum toxin are effective, but the effect lasts only up to six months.

[0006] Permanent options are surgical. Although effective, even the lesser invasive operations have possible surgical risks and downtime. [0007] It is known that energy-based therapies like laser therapy can be applied to tissue throughout the body to achieve numerous therapeutic and/or aesthetic results.

[0008] However, there is no effective nonsurgical, low-risk treatment of focal hyperhidrosis so far. There exists a need for the treatment of hyperhidrosis without surgical scarring or side effects of more invasive techniques. Also, patients would be most interested in a low-risk treatment, that can be done at home, although the results of such a treatment may be temporary.

Therefore, effective and improved methods, systems and apparatuses that are able to treat hyperhidrosis non-invasively with no additional risk are needed.

SUMMARY OF THE DISCLOSURE

[0009] In a first aspect, embodiments of this disclosure provide medical electromagnetic energy systems suitable for the temporary reduction of sweating, comprising an electromagnetic energy emitter coupled to an electromagnetic energy source, wherein the electromagnetic energy source delivers thermal energy between 25 and 50 J/cm2 via the electromagnetic energy emitter through the skin surface to a sweat glands containing tissue site, wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited. In a further aspect, embodiments of this disclosure relate to methods of treating and preventing focal hyperhidrosis which comprise administering to a patient in need of such treatment or prevention electromagnetic energy.

[0010] In still another aspect, embodiments of this disclosure relate to medical ultrasound energy systems suitable for the temporary reduction of sweating, comprising an ultrasound energy emitter coupled to an ultrasound energy source, wherein the ultrasound energy source delivers ultrasound energy between 40 to 60 J/cm2 via the ultrasound energy emitter through the skin surface to a sweat glands containing tissue site, wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited. [0011] In a further aspect, the present disclosure pertains to methods for the noninvasive ly temporary treatment of hyperhidrosis and/or normohydrosis by exposing an area of skin tissue comprising a layer of sweat glands to an electromagnetic energy, whereby the electromagnetic energy is delivered from an electromagnetic energy source through the skin surface to the sweat glands containing tissue site, and wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site during the treatment; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited.

[0012] In a further aspect, the present disclosure pertains to methods for the noninvasive ly temporary treatment of hyperhidrosis and/or normohydrosis by exposing an area of skin tissue comprising a layer of sweat glands to an ultrasound energy, whereby the ultrasound energy is delivered from an ultrasound energy source through the skin surface to the sweat glands containing tissue site, and wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site during the treatment; and the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited.

In another aspect aspect, the present disclosure pertains to uses of electromagnetic or ultrasound energy for the temporary reduction of sweat glands, wherein: a) an electromagnetic or ultrasound energy source is provided;

b) energy is delivered from the energy source through the skin surface to the sweat glands containing tissue site, wherein the temperature of the skin surface is less than the temperature of the sweat glands containing tissue site; and c) the sweat glands are reduced or temporarily inhibited or their innervation is temporarily inhibited.

The present disclosure pertains also to methods for reducing sweat glands in a selected sweat glands containing tissue site beneath an epidermis skin surface, comprising: a) providing an electromagnetic or ultrasound energy source with an energy delivery surface; b) positioning the energy delivery surface on the epidermis skin surface; c) creating an uniform reverse thermal gradient through the skin epidermis surface where a temperature of the skin epidermis surface is lower than the selected sweat glands containing tissue site; and d) delivering energy from the energy source through the skin epidermis surface to the selected sweat glands containing tissue site for a sufficient time to reduce a plurality of sweat glands in the selected sweat glands containing tissue site.

BRIEF DESCRIPTION OF THE FIGURES

[0013] FIG. 1 is a perspective view of an example of an apparatus for applying electromagnetic energy through the skin in order to cause a reduction of sweat glands.

DETAILED DESCRIPTION OF THIS DISCLOSURE

[0014] Disclosed herein are medical systems, novel uses and methods for the temporary treatment of sweating.

[0015] It is an idea of the present disclosure to treat sweating in a person of need with an apparatus delivering low portions of energy, in particular ultrasound or electromagenetic energy, to a sweat glands containing tissue site. In particular, the energy is less intensive than the energy applied in a typical doctor's procedure for the treatment of hyperhidrosis.

[0016] Due to applying less energy than in a hyperhidrosis treatment procedure, there are less side-effects, no local anesthesia is needed and the treatment can be performed at home, and no medical doctor is needed.

[0017] Due to the treatment with less electromagnetic or ultrasound energy, nerval pulses or glands are inhibited and/or parts of nerves, ducts or glands are denaturized. All these effects are mostly temporary. As mentioned above, the treatment is a low-risk procedure and can be done with a home-use device without supervision of a doctor or medical professional.

[0018] In an advantageous embodiment, the amount of energy transferred via ultrasound may be between 40 to 60 J/cm 2 , in particular between 45 to 55 J/cm 2 , more particular 47 J/cm 2 , the electromagnetic energy transferred to the area of need is between 25 and 50 J/cm 2 , in particular between 30 to 40 J/cm 2 , more particular 35 J/cm 2 .

[0019] The present disclosure provides methods for temporary reducing sweat glands e.g. for the temporary treatment of hyperhidrosis below a tissue surface in a selected tissue site.

[0020] The reduction or elimination of sweat glands can be done preferably transcutaneously, with a uniform reverse thermal gradient, percutaneously, transmucosally, permucosally, or through a device including but not limited to an endoscope. An electromagnetic or ultrasound energy apparatus is provided and includes an electromagnetic or ultrasound energy source and a delivery device. The delivery device is positioned on the tissue surface. Low electromagnetic or ultrasound energy is produced from the electromagnetic or ultrasound energy source and delivered through the tissue surface to the selected tissue site for a sufficient time to temporary reduce sweat glands in the selected tissue site. No burn is formed on the tissue surface. This method is particularly useful with a home-use device without supervision of a doctor or other medical professional.

[0021] However, to be able to treat hyperhidrosis effectively, it is crucial to destroy most of the sweat glands, not just a few of them. This can only be done by apllying high intensive energy e.g. via a laser or a high energy ultrasound system.

[0022] With the methods according to the present disclosure it is possible to reduce temporary a plurality of sweat glands in the selected sweat glands containing tissue site by an end-user.

[0023] Most preferably, one such low energy exposure penetrates the skin and other tissue and is absorbed by at least some sweat glands or their innervation. These sweat glands are then paralyzed or partially destroyed or the innervation is temporarily blocked. [0024] Hyperhidrosis can either be generalized or localized to specific parts of the body. Hands, feet, armpits, and the groin area are among the most active regions of perspiration due to the relatively high concentration of sweat glands; however, any part of the body may be affected. Hyperhidrosis can also be classified depending by onset, congenital or acquired. Primary hyperhidrosis is found to start during adolescence or even before and seems to be inherited as an autosomal dominant genetic trait. Primary hyperhidrosis must be distinguished from secondary hyperhidrosis, which can start at any point in life. The latter form may be due to a disorder of the thyroid or pituitary gland, diabetes mellitus, tumors, gout, menopause, certain drugs, or mercury poisoning.

[0025] Hyperhidrosis may be also divided into palmoplantar (symptomatic sweating of primarily the hands or feet), gustatory and generalized hyperhidrosis. Alternatively, hyperhidrosis may be classified according to the amount of skin that is affected and its possible causes.

[0026] The methods of the present disclosure use an electromagnetic or ultrasound energy source to apply electromagnetic or ultrasound energy to a selected tissue site. The electromagnetic or ultrasound energy can be delivered transcutaneously, with a reverse thermal gradient, percutaneously, transmucosally, permucosally, or through a device including but not limited to an endoscope.

[0027] Additionally, the methods of the present invention provide for the reduction of sweat glands underlying a tissue surface area. The overlying layer of tissue is not ablated. No deeper than a second degree burn is produced in the overlying layer of tissue, and preferably no deeper than a first degree burn.

[0028] Suitable applications for the methods of the present disclosure include but are not limited to the treatment of sweating due to hyperhidrosis, normohydrosis bromhidrosis, hidradenitis suppurativa, hypohidrotic ectodermal dysplasia, hypotrichosis, anodontia, hypohidrosis, hidrotic ectodermal dysplasia, uremic frost, neoplasms, syringomata, and various forms of miliarias. Preferably, the methods according to the present disclosure are useful for the treatment sweating due to hyperhidrosis, in particular due to Hyperhidrosis axillaris and Hyperhidrosis palmaris.

[0029] In one embodiment, an apparatus is used to create the uniform reverse thermal gradient is a composite heating pad that has both cooling elements and electromagnetic delivery devices. The heating pad is configured to the topography of the treatment area and is incorporated into an elastic garment. Partial reduction of sweat glands is achieved with each treatment. Thermal transducers measure the surface temperature of the treatment area to avoid blistering. In one embodiment the deeper dermis is heated to above 65 degrees for sweat glands destruction. Sequential treatments are designed to allow for more precision of the end result. Areas of application are not confined by requirements to either hide surgical incisions or transition along aesthetic boundaries.

[0030] The radiofrequency treatment according to the present disclosure delivers almost uniform and deep heating since only with almost uniform and deep heating it is possible to coagulate enough sweat glands to treat hyperhidrosis effectively.

[0031] A uniform reverse thermal gradient means that the energy delivery surface uniformly distributes the thermal gradient through the skin epidermis surface to the selected sweat glands containing tissue site.

[0032] Various types of electromagnetic energy can be utilized with the present disclosure. Electromagnetic energy may be any kind that can cause cell heating or physical destruction by being applied to collagen tissue.

[0033] FIG. 1 shows an example of an apparatus 10 applies electromagnetic energy through a skin layer 12, such as the epidermis, and to the underlying sweat glands tissue 14 without substantially modifying melanocytes and other epithelial cells 16 found in the lower layer of epidermis layer 12. A porous membrane 18 is adapted to receive an electrolytic solution 20. Porous membrane 18 becomes inflated to substantially conform a contacting exterior surface 22 of porous membrane 18 which is in close thermal contact with epidermis 12. Porous membrane 18 includes a cooling lumen 24 for receiving a cooling fluid that imparts a cooling effect on epidermis layer 12.

[0034] One or more electromagnetic electrodes 26 are positioned at various places in porous membrane 18. In one embodiment, electromagnetic electrodes 26 are positioned on a side that is substantially opposing to contacting exterior surface 22. In other embodiments, electromagnetic electrodes 26 are placed closer to cooling lumen 24. In embodiment particularly suitable for the hips, porous membrane is about 20 cm by 30 cm, with an oval shape. [0035] An electromagnetic power source 28 is coupled to electromagnetic electrodes 26 and a source of electrolytic solution 30 is coupled to porous membrane 18.

[0036] Various examples of an apparatus useful for the methods according to the present disclosure are described in the US patent US 6,241,753, US 6,311,090, US 6,350,276, US 6,377,855, US 6,381,497, US 6,381,498, US 6,387,380, US 6,425,912, US 6,405,090, US 6,453,202, US 7,022,121, US 7,258,674 and US 7,841,984 which are hereby incorporated by reference.

[0037] In one method of the present disclosure, sweat glands tissue in a dermis underlying the epidermis of the skin is transcutaneous contracted with the use of a thermal heating apparatus. Electromagnetic energy is transcutaneous delivered through the epidermis to the underlying dermis.

[0038] In one embodiment of the present disclosure, the method comprises the use of an ultrasound energy system - in particular, a system with a plurality of independently controlled multiple beam transducer elements that are capable of being focused at the treatment depths below the skin surface.

[0039] As mentioned above, one example for an apparatus comprising an ultrasounbd energy source is the Liposonix® device or any similar devices.

[0040] With the methods according to the present disclosure, the severity of the symptoms of focal hyperhidrosis can be temporarily reduced. For example, the severity of excessive sweating or other fluid weeping from the skin, erythematous, leathery appearance and texture, and associated pain and discomfort can be reduced.

[0041] In a preferred embodiment of the present disclosure, the methods and uses involve non-invasively treating the affected area with one of the mentioned devices, a gel sheet and a transducer, generally penetrating the skin deeply and creating a lesion in the target area.

[0042] In an embodiment, the methods and uses involves at least one or two such applications separated by two to six, and preferably four week intervals.

[0043] In another embodiment, local anesthetic cream or injection or block may be applied before the treatment. Alternatively, intravenous deep sedation or anesthesia may be used. [0044] In one embodiment of the present disclosure the Liposonix® system was used for the treatment of hyperhidrosis. The Liposonix® system is used in the prior art to apply high intense focused ultrasound to create heat and shear forces, to destroy target structures in the subcutaneous fat, adipocytes, to achieve nonsurgical body sculpting effects. The lesions induce a wound healing effect, macrophages and other cells clear up the cellular debris of disrupted adipocytes, thus leading to volume loss.

[0045] In an embodiment, the ultrasound device is used with a specific transducer and a gel sheet. In preferred embodiments, the device is used for the treatment and then waiting two to six, and most preferably four, weeks after the first treatment, and then repeating this process one or more times if necessary.

[0046] Most preferably, one such ultrasound exposure penetrates the diseased tissue and is absorbed by at least some sweat glands. These sweat glands are then disrupted and then resorbed.

[0047] The novel use of the devices leads to a treatment which is non-invasive, which can be of very significant benefit to the health care practitioner and the affected patient. The most preferred method is also believed to be very safe and easy and economical to administer without any significant complications for any patient as a result of the preferred type of treatment and procedure.

[0048] Further advantages of the high intense focused ultrasound treatment of hyperhidrosis is likely useable to treat conditions of hyperhidrosis and other conditions, that may not qualify for a diagnosis of hyperhidrosis, but exhibit similar symptoms.

[0049] In a further embodiment the present disclosure relates to the treatment of sweating due to hyperhidrosis like focal hyperhidrosis with low radiofrequenncy (RF) energy.

[0050] In embodiments according to the present disclosure apparatuses and/or systems were used for applying nonablative capacitive radiofrequency energy.

[0051] In one embodiment capacitive radiofrequency energy and surface cooling are applied by use of the Thermacool® TC3 or NXT or CPT from Solta Medical, Inc., 25881 Industrial Boulevard Hayward, CA 94545, USA or any similar devices. [0052] In a preferred embodiment the radiofrequency energy device is used with an electrode comprising specific treatment tips. The specific treatment tips can be internally and/or externally cooled.

[0053] In an embodiment according to the present disclosure, the Thermacool®

TC3 or NXT or CPT was used in the treatment.

[0054] In one embodiment, the uses and/or the methods comprises radiation exposure involving treating the diseased tissues with a capacitive, nonablative radiofrequency device such as Thermacool TC3 or NXT or CPT with a specific treatment tip with surface cooling.

[0055] In an preferred embodiment, after the first treatment and before the next treatment it is preferred to wait two to six, and most preferably four, weeks, and then repeating this process at one or more times if necessary.

In one embodiment, local anesthetic cream or injection or block may be applied before the treatment. Alternatively, intravenous deep sedation or anesthesia may be used.

[0056] Most preferably, one such radiofrequency exposure penetrates the diseased tissue and is absorbed by at least some sweat glands. These sweat glands are then heated and destroyed.

[0057] "Standard thermal gradient" is the thermal content of tissue that is greater on the skin surface.

[0058] "Reverse thermal gradient" is, (i) the application of electromagnetic energy to alter the biophysical properties of sweat glands, i.e., reduction, with minimal blistering of the tissue surface, (ii) a gradient in which the tissue surface temperature is cooler than the underlying sweat glands comprising tissue, (iii) conditions in which a standard thermal gradient is reduced or equalized in temperature between the tissue surface and the underlying sweat glands, or (iv) monitoring the heat content (temperature and exposure duration) of the tissue surface to avoid blistering during treatment, regardless of the tissue surface temperature relative to the underlying sweat glands tissue.

[0059] "Transcutaneously" means that the delivery device delivers electromagnetic energy directly through the tissue surface. [0060] "Sweat glands" are small tubular structures of the skin that produce sweat including eccrine sweat glands which can be distributed all over the body although their density varies from region to region and apocrine sweat glands. In advantageous embodiments, the eccrine sweat glands are reduced by the methods according to the present disclosure.

[0061] "Low energy" according to the present disclosure means in advantageous embodiments energy levels delivered to the skin surface below 100 J/cm2.

[0062] In one embodiment a hand wand is used for the temporary treatment of hyperhidrosis according to the present disclosure, wherein the wand comprises: a first controlling device operably controlling an ultrasonic imaging function for providing ultrasonic imaging; a second controlling device operably controlling an ultrasonic treatment function for providing ultrasonic treatment; a movement mechanism configured to direct ultrasonic treatment in a linear sequence of individual thermal lesions; and at least a first and a second removable transducer module, wherein said first and second transducer modules are configured for both ultrasonic imaging and ultrasonic treatment, wherein said first and second transducer modules are configured for interchangeable coupling to the hand wand, wherein said first transducer module is configured to apply ultrasonic therapy to a first layer of tissue, wherein said second transducer module is configured to apply ultrasonic therapy to a second layer of tissue, wherein the second layer of tissue is at a different depth than the first layer of tissue, and wherein said first and second transducer modules are configured to be operably coupled to at least one of said first controlling device, said second controlling device and said movement mechanism. One example for a system that can be used for the treatment of hyperhidrosis is described in WO2009/149390 Al which is hereby incorporated by reference.

[0063] In several embodiments, a hand wand is used for the treatment of hyperhidrosis according to the present disclosure. In accordance with one embodiment, the hand wand comprises a first controlling device, a second controlling device, a movement mechanism, and a transducer module. The first controlling device operably controls an ultrasonic imaging function for providing ultrasonic imaging. The second controlling device operably controls an ultrasonic treatment function for providing ultrasonic treatment. The movement mechanism is configured to direct ultrasonic treatment in a sequence of individual thepnal lesions. The removable transducer module is configured for both ultrasonic imaging and ultrasonic treatment. The removable transducer module is configured for interchangeable coupling to the hand wand. The removable transducer module is configured to be operably coupled to at least one of said first controlling device, said second controlling device and said movement mechanism. The removable transducer module is configured to apply ultrasonic therapy to at a first variable ultrasonic parameter to tissue.

[0064] It is to be understood that the foregoing is merely a brief summary of aspects of the invention. Other aspects, advantages, and objects of the invention will become apparent as the specification proceeds. The scope of the present invention is therefore to be determined by reference to the issued claims and not by whether given subject matter meets all objects or advantages set forth herein or solves, or reduces the severity of, all issues or problems in the prior art noted above.

[0065] The following examples and methods are offered for illustrative purposes only, and are not intended to limit the scope of the present disclosure in any way.

[0066] Examples

[0067] A series of clinical studies in human subjects have been performed to support the clinical evaluation of the novel uses of the apparatuses according to the present disclosure. These studies were performed in accordance with internationally recognized guidelines for study design.

[0068] Example 1

[0069] Patient 1

[0070] Patient 1 was 26yrs and diagnosed with Hyperhidrosis axillaris. The disease started at the age of 14yrs and never stopped. Iontopheresis or systemic therapy was not sufficient. Gravimetry showed excessive sweating of 141mg/min on the right side and 149mg/min on the left side. The patient also suffered from discomfort in the diseased area, Mycosis appeared. [0071] The patient's hyperhidrosis condition was stable but included the significant problematic symptoms noted above.

[0072] The patient's axillae were treated with the Liposonix® device and a gel sheet, applying ultrasound to this patient with certain appropriate energy levels and penetration depths and appropriate number of pulses and passes.

[0073] Immediately after the treatment, this patient noted improvement in sweating and discomfort. Gravimetry showed significant reduction to 17mg/min on the right side and 21mg/min on the left side. The patient was satisfied. The result was only temporary, sweating was back to previous levels 7days after the procedure.

[0074] There was no pain during the treatment and no complication after.

[0075] Example 2

[0076] Patient 2

[0077] Patient 2 was 31yrs and, through steps one and two, diagnosed with

Hyperhidrosis palmaris. The disease started at the age of 16yrs and never stopped. Iontopheresis or AlCl was not sufficient. Gravimetry showed excessive sweating of 86mg/min on the right side and 72mg/min on the left side. The patient also suffered from discomfort in the diseased area.

[0078] The patient's hyperhidrosis condition was stable but included the significant problematic symptoms noted above.

[0079] The patient's palms were treated with ultrasound of Ulthera®, with the appropriate energy and penetration levels and appropriate number of pulses and passes, with a waiting time of four weeks before repeating the treatment.

[0080] Immediately after the first treatment, this patient noted improvement in sweating and discomfort. Gravimetry showed significant reduction to 22mg/min on the right side and 21mg/min on the left side. The patient was satisfied. Two weeks later, the sweat level was back to normal. [0081] Patient 3

[0082] Patient 3 was 37yrs and diagnosed with Hyperhidrosis axillaris. The disease started at the age of 15yrs and never stopped. AlCl and iontopheresis were not sufficient. Gravimetry showed excessive sweating of 161mg/min on the right side and 186mg/min on the left side. The patient also suffered from discomfort and temporary mycosis in the diseased area.

[0083] The patient's hyperhidrosis condition was stable but included the significant problematic symptoms noted above.

[0084] The patient's feet were treated with ultrasound of Ulthera® with the appropriate energy levels and appropriate penetration depths and appropriate number of pulses and passes, with a waiting time of three days before repeating the treatment a second and a third time.

[0085] After the third treatment, this patient noted improvement in sweating and discomfort. Gravimetry showed significant reduction to 21mg/min on the right side and 20mg/min on the left side. The patient was satisfied for about two weeks before the sweating reaccured and got back to pre-treatment levels.

[0086] There was no pain during the treatment and no complication herein after.

[0087] It can thus be seen from the examples above that the disclosed technology technique using ultrasound energies, to greatly reduce and in some cases eliminate the symptoms of hyperhidrosis temporarily. In doing so, this ultrasound energy either heats and partially disrupts the target structures, such as sweat glands, while other structures such as epidermis superficial to the target or other structures deeper to the target are protected, or it just paralyses the sweat glands or their innervation. This treatment can be done at home or any other institution, preferably with a handheld device. It is pain-free and low risk, it can therefore be done without a doctor's supervision.

[0088] Example 4

[0089] Patient 4 [0090] Patient 4 was 42yrs and diagnosed with Hyperhidrosis axillaris. The disease started at the age of 14yrs and never stopped. AlCl was not sufficient. Gravimetry showed excessive sweating of 221mg/min on the right side and 201mg/min on the left side. The patient also suffered from discomfort in the diseased area.

[0091] The patient's hyperhidrosis condition was stable but included the significant problematic symptoms noted above.

[0092] The patient's axillae were treated with non ablative capacitive radiofrequency radiation to this patient with the appropriate energy levels and appropriate number of pulses, while cooling the skin during the pulse. The treatment was repeated one day and two days after the first procedure.

[0093] Immediately after the treatment, this patient noted improvement in sweating and discomfort. After the third treatment, gravimetry showed significant reduction to 25mg/min on the right side and 39mg/min on the left side. The patient was treated a second time four weeks later. The patient was satisfied. The result was temporary and excessive sweating reacurred lOdays after the last treatment.

[0094] There was no pain or other complications during or after the treatments.

[0095] Example 5

[0096] Patient 5

[0097] Patient 5 was 35yrs and diagnosed with Hyperhidrosis palmaris. The disease started at the age of 18yrs and never stopped. Iontopheresis was not sufficient. Gravimetry showed excessive sweating of 125mg/min on the right side and 180mg/min on the left side. The patient also suffered from erythema and discomfort in the diseased area.

[0098] The patient's hyperhidrosis condition was stable but included the significant problematic symptoms noted above.

[0099] The patient's palms were treated three times with non ablative capacitive radiofrequency radiation with the appropriate energy levels and appropriate number of pulses and with a waiting time of two days before repeating the treatment. Immediately after the first treatment, this patient noted improvement in sweating and discomfort. After the third procedure, gravimetry showed significant reduction to 19mg/min on the right side and 23mg/min on the left side. The patient was satisfied. Sweating was back to pre-treatment levels 8days after the last procedure.

[00100] There was no pain or any complication during or after the treatments

[00101] Example 6

[00102] Patient 6

[00103] Patient 6 was 45yrs and diagnosed with Hyperhidrosis axillaris. The disease started at the age of 16yrs and never stopped. AlCl was not sufficient, Btx was effective for 5mths. Mycosis appeared. Gravimetry showed excessive sweating of 169mg/min on the right side and 206mg/min on the left side. The patient also suffered from discomfort in the diseased area.

[00104] The patient's hyperhidrosis condition was stable but included the significant problematic symptoms noted above.

[00105] The patient's axillae were treated three times with non ablative capacitive radiofrequency radiation with the appropriate energy levels and appropriate number of pulses, with a waiting time of four days before repeating the treatment.

[00106] Immediately after the first treatment, this patient noted improvement in sweating and discomfort. After the third treatment, this patient's hyperhidrosis was eliminated temporarily and the patient was satisfied. Gravimetry showed significant reduction to 15mg/min on the right side and 15mg/min on the left side. Sweat levels were back to actual levels 3wks after the third procedure.

[00107] There was no pain or other complication during or after the treatments.