(12) INTERNAT (19) World Intellectual Property 5 a Z = (43) International Publication Date 22 March 2018 (22.03.2018) ONAL APPLICATION PUBLISHED UNDER THE PA’ NT COOPERATION TREATY (PCT) AUTON UE 01 (10) International Publication Number WO 2018/051231 Al WIPO! PCT G1) International Patent Classiieat AGIN 1/00 (2006.01) A61F 5/00 (2006.01) 21) International Application Number: PCTHNB2017/055508 (22) International Fling Dat 12 September 2017 (12.09.2017) 25) Filing Language: English (26) Publication Language: English 0) Priority Data: 139350140003007571 13 September 2016 (13,09.2016) IR @ a Inventors; and Applicants: AZHARL, Amin (IRVIR}; Emam Reza bos- pital, Mashhad University of Medical Sciences, Mashhad (R). NOURIZADEH, Navid [IRR]: Emam Reza bos: pital, Mashhad University of Medical Sciences, Mash- hod (IR). ALLAH, Esmaell (IRR), Unite? 8, No. 236, Nofeloshato 26th, Nofeloshato St, Kalantar highway, Mashhad (IR. Designated States (unless otherwise indicated, for every ind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA,CH, CL,CN, CO, CR, CU, CZ, DE, DI, DK, DM, DO, DZ,EC, BE, FG, FS, Fl, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, 18, JO, JP, KE, KG, KH, KN, KP, KR, KW,KZ,LA,LC,LKLR,LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, en 3) SC, SD, SE, SG, SK, SL, SM, ST, SV, SY,TH,TJ, TM, TN, ‘TR,TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW Designated States (unless osherwise indicated, for every ind of regional proxection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST,SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TH, ‘TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, 3, FS, Fl, FR, GB, GR, HR, HU, IF, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BE. BI, CF, CG, C1, CM, GA, GN, GQ. GW KM, ML, MR, NE, SN, TD, TG) Published With international search report (Ar. 21(3)) with amended claims (Art. 19(1)) wo 2018/051231 A1 III (Ga) Tide: SMART ORTHOSIS WITH FLECTROTHERAPY, THERMOTHERAPY, AND VIBRATION CAPABILITIES FOR IN- HOME PHYSIOTHERAPY (67) Abstract: The present invention is smart orthosis with the electrotherapy, thermotherapy and vibration capabilities to perform in-home physiotherapy, which is related to the area of human needs in health sections. Physiotherapy, which is prescribed for many musculoskeletal s well as brain and nerve diseases, is mainly performed in clinies through multiple sessions, requiring a lot of time and money Therefore, we aimed to produce this device, which is mainly established to com= plete physiotherapy programs outside clinics and without the need for multiple re- ferral of patients to receive rehabilitation services. Application of this device not only reduces healthcare costs of patient health status. Another important application ofthis device is dermal absorption of topical drugs, On the fist refer, vibrator, as well as heat and electricity systems of the device are adjusted by the therapist, so thatthe patient is able ro use the de- Vice at home. In dditon, the therapist can monitor the teatinent process of patients through related website and software, but it also significantly promotes theirWO 2018/051231 PCT/1B2017/055508 SMART ORTHOSIS WITH ELECTROTHERAPY, THERMOTHERAPY, AND VIBRATION CAPABILITIES FOR IN-HOME PHYSIOTHERAPY Technical |d of Invention: [0001] The present invention is related to the field of human needs in the health sector. Specifically, this invention is related to medical equipment used for physiotherapy. Background: [0002] Physiotherapy is one of the major branches of rehabilitation medicine used in treatment of many musculoskeletal, neurological and cardiovascular problems. In this knowledge, various techniques are applied to treat patients, one of the most important of which is physics (electricity, heat and skin vibration). Currently, rehabilitation services are divided into two sections: center-based and home-based, [0003] There has been a constant increase in scientific evidences suggesting the positive effects of in- home rehabilitation. Today, rehabilitation services at home are mainly network-based or provided by visit of therapists. The former method is mainly used for education, where the physician teaches the necessary moves to patients to be performed at home. In the second method (visit of therapists), presence of all modalities at the bed of patients is practically difficult. It should be noted that in the majority of cases, several physiotherapy sessions are held, which exceeds to dozens of sessions in some cases. Therefore, there is a need for frequent and time-consum ng visits, which is one of the disadvantages of physiotherapy in clinics. [0004] In addition to the required educations about physiotherapy, the major part of rehabilitation programs include exercise therapy, Kinesiotherapy, electrotherapy, thermotherapy and massage Among the mentioned items, kinesiotherapy and exercise therapy can be taught to the patients or their companions. However, provision of the ability to perform electrotherapy, thermotherapy and vibration at home can significantly decrease the visit of patients by therapists. [0005] Orthoses are the most important means of rehabilitation, which improve muscle and joint function and decrease pain through biomechanical correction. Studies conducted on this area have shown the lack of a smart orthosis with an ability to control, which can simultaneously provide the mentioned services in a portable manner. The mentioned invention provides the opportunity for patients to perform physiotherapy sessions under the remote monitoring of their therapist after obtaining the primary educations. By creating this tool, we aimed to bring together the benefits of home-based and center-based physiotherapy through providing the possibility to performWO 2018/051231 PCT/1B2017/055508 2 electrotherapy, thermotherapy and vibration outside of clinics and monitoring of the treatment process of patients by the rehabilitation team. All of the mentioned benefits of this device lead to relatively low costs for the health system and patients, Industrial applicability: 10006] This device has been manufactured to perform a major part of physiotherapy program outside of clinics, and can be used to treat musculoskeletal pain, neurological problems and dermal absorption of topical drugs. Best mode for carrying out the invention: [0007] On the first referral, heating and electricity system of the device are adjusted by therapists in proportion to the condition of patients, who can then use the device on their own, Moreover, therapist can monitor the treatment process performed by patients through the control system of a software established for this purpose. BRIEF DESCRIPTION OF THE DRAWINGS [0008] Samples of some of the patents are presented in maps for better comprehension of the invention, However, invention is not limited to the specific methods and structures presented here. In the figures, a letter is determined for each component, which are explained in the invention description section by the same letters. [0009] Figure 1, A sample of the device, which is used for waist. [0010] Figure 2. A sample of the device, which is used for face. 10011] Figure 3, Silicon element for orthosis heating 10012] Figure 4, Vibration motor used in orthosis, [0013] Figure 5. TENS pads specifically for nerve electrical stimulation [0014] Figure 6, Orthosis control section Disclosure of Invention: 10015] According to FIG 1 and 2, this invention is a smart orthosis with electrotherapy, thermotherapy and vibration abilities in order to perform physiotherapy at home. In general, this device is comprised of four major parts, as follows: + Heat section (A) * Massage section (vibration) (B) * Electrical stimulation section (C)WO 2018/051231 PCT/1B2017/055508 * Control circuit (D) 10016] The heat section (A) is designed to increase tissue metabolism and decrease pain. Blood flow increases in tissue after tissue heating, which leads to accelerated recovery of patients, In this section, silicone elements are used, which in addition to heating efficiency, have high flexibility and low eight and diameter, compared to other samples. It should be noted that this orthosis is manufactured using skin-friendly materials, such as latex and anti-allergy tarpaulins. [0017] The massage section (B) performs the massage of the skin and subcutaneous tissues, leading to relaxation of these body parts, Therefore, a very small vibration motor is used in this section, vibration of which can be controlled by the control section (D).. [0018] ‘The electrical stimulation section (C) is for stimulation of a group of muscles and nerves to maintain elasticity and normal state of the muscles and improve their performance. In cases of neurological damage, this method reduces muscle loss, and can improve the health state of patients, when pain is their major problem. [0019] In nervous stimulation method, some electrical signals are sent, which are essentially similar to nerve impulses that send a healthy nerve to the muscles. This method is sometimes recognized as neurotrophic stimulation. transcutaneous electrical nerve stimulation (TENS) pads are used to perform nerve stimulation. with regard to the problem region of patients, these pads are placed on specific parts of orthosis, and their frequency of electrical stimulation can be adjusted by patients or therapists, 10020] Control section (D) contains some switches to increase or decrease the massage level and an have various electrical stimulation adjust heat and electrical stimulation. In addition, this device modes. In addition to direct use of city electricity, this device can operate on batteries as well, enabling patients to use even in motion.WO 2018/051231 PCT/1B2017/055508 CLAIMS What is claimed is: 1, Production of a smart orthosis with electrotherapy, thermotherapy and vibration abilities to perform physiotherapy at home. This device is made of skin-friendly materials, including latex and anti-allergy tarpaulins, and contains four major parts: ‘+ Heat section ‘+ Massage section (vibration) ‘+ Electrical stimulation section © Control circuit 2, Use of silicone elements in heat section, which leads to increase of blood flow in tissues by heating the region. 3. Use of a vibration motor, level of which can be adjusted by the control section. In this device, the abilities of electrotherapy and vibration can be used simultaneously. 4, Stimulation of muscles and nerves by TENS pads. These portable pads are located on specific areas and their frequency of electrical stimulation can be adjusted by patients or therapists. 5. Adjustable nature of the device due to its control circuit. This device can be control by user from distance. Moreover, therapists can monitor the treatment process performed by patients by the controlling system accessible through installing the software of the device. 6, Portable nature of the device and lack of need for city electricity, being able to be charged by power banks and similar devices. 7. This invention is established to perform a major part of physiotherapy programs outside of clinics, and can be used in treatment of musculoskeletal pain, neurological problems and dermal absorption of topical drugs.WO 2018/051231 PCT/1B2017/055508 5 AMENDED CLAIMS received by the International Bureau on 13 February 2018 (13.02.2018) 1- Smart orthosis with simultaneous electrotherapy, thermotherapy and vibration ability for in-home physiotherapy and consists four major parts: * Heating section (A); * Vibration section (B); # Electrical stimulation section (C); * Control circuit (D). 2 The orthosis of claim 1, silicone elements are applied in the heating section (A) in order to increase the tissue blood flow by heating the tissue. 3- The orthosis of claim 2, thermal sensors have been placed between the elements to control the created heat. This process is associated with the transfer of orthotic temperature data to the control section, which decides to whether decrease or increase the temperature of the hat. 4- The orthosis of claim 2 and 3, in this system, the pulse-width modulation (PWM) technique is used to transfer energy to the elements. 5- The orthosis of claim 1, a vibration engine (B) is applied to create vibration and massage. In addition, the vibration level of the device can be changed by the control section (D). 6 The orthosis of claim 1, electrical stimulation (C) is carried out with the use of TENS pads in muscles and nerves. In order to create nervous stimulation, electrical signals are sent, which are fundamentally similar to those nervous impulses that send a healthy nerve to the muscles. 7- The orthosis of claim 6, to initiate stimulation, circuit power supply voltage is increased to 40 V by a voltage-increasing circuit and the amount of applied flow and stimulation frequency are controlled by a bipolar transistor. 8 The orthosis of claim 6, these portable pads have been placed in specific paths in orthosis. Frequency of electric stimulation of the pads can be adjusted by patients or therapists. AMENDED SHEET (ARTICLE 19)WO 2018/051231 PCT/IB2017/055508 9- The orthosis of claim 1, the control circuit (D) provides the ability to adjust the device, and contains switches for increasing or reducing the level of massage and heat. Moreover, there is the possibility of having various electrical stimulation modes by the device 10- The orthosis of claim 9, a software has been developed for the device, which can be installed on smart phones and can help control all of the mentioned parameters. Using the app, the therapist can select the level of thermal, vibrational and electrical stimulations on his smart phone and send the information to the processor in the orthosis in order to control the treatment schedule and intensity of each of the mentioned stimulations. 11- The ortho of claim 10, the software saves all of the treatment information in a data package, which is sent to the processor of orthosis via Bluetooth. After receiving the package, the information is processed and personal treatment schedule of each patient during the required time is sent to various sections of the system by the processor. 12- The orthosis of claim 1, the invented device is portable and requires no electricity for charging, This device can be charged by power bank or similar devices. 13- The orthosis of claim1, this orthosis has simultaneous electrotherapy, thermotherapy, and vibration abilities and can be used as an in-home device. In addition, patients can easily use the device in motion. 14- The orthosis of claim 1, this orthosis is produced with skin-compatible materials, including latex and anti-allergic tarpaulins, 15- The claimed invention has been manufactured for performing a major part of the physical therapy program. This device can be applied in treatment of musculoskeletal pain and neurological problems and also dermal absorption of topical drugs. AMENDED SHEET (ARTICLE 19)WO 2018/051231 PCT/1B2017/055508 ws FIG.2WO 2018/051231 24 FIG.3-A 1.8 FIG.4-BWO 2018/051231 34 FIG.S-C 1D 2.0 2.0 FIG.6-DWO 2018/051231 PCT/1B2017/055508 48 FIG.3(A) : Heat Pad 1 ire 2.A: silicone 3.A: metal FIG.4(B) : Vibration motor 1.B : wire 2.B: DC motor FIG.5(C) :TENS Pad 1.C: wire 2.C : conductive silicone substrate FIG.6(D) : Controller 1.0 : Display : Control keysINTERNATIONAL SEARCH REPORT International applisalion No PCT/1B2017/055508 CLASSIFICATION OF SUBIECT MATTER A61N1/00,AG1F5/00 Version=2017.01 According to Internationa Patent Classification (IPC) orto both national classtiation and IPC B__ FIELDS SEARCHED “Minimum dosumontation search (lewifcaion system followed by caseation symbols) AGIN, Ai ‘Decwmenaton searched oer th minimum docrmenaton othe extent hat sash docomaats are incl inthe il searched lcci database consulted during te lntcrational search (anne of database and, whore wacicable, search ters used) Patseer, IPO Internal Database KEYWORDS :ELECTROTHERAPY, THERMALTHERAPY, TENS a Catepory* | Citation of document, with indication, where appropriate of the relevant passages Relevant o ei No, ¥ ‘US4232680 A (HUDLESON BRUCE D ET.Al) 11 November [1-7 1980 (11-11-1980) Refer fig2, Col.no.5,lines.60-65 and Col.no.4, lines, 40-45 YX Us2012221073 Al (SOUTHWELL BRIDGET RAE ET.AL) 30 | 1-7 august 2012 (30-08-2012) Refer abstract and desc paragraphs 0021, 0018 and 0045 and claims 13-15, 16 Fore doumeat Ine in th contmaton of Box © Sez pte amily ame, +S sagan 0 cad doe ocumeat defining the gene sist of teat which sno conse tobe parcel eetance “=P tr dace psc ache inernational ling dae or pray ean ot oof wih he epticaon tu cts to undrant ‘he rnp theory undying tients “EP” eqriorapplicain a pau but publishad on or after dhe ineraonal °K" docamet of pectic relevance; the ld invention sennot be ming dat ‘cance nal or cane fe coast wolves ae 2 docs may ho us presi clas)c hh ie Sepon he sst aes e ‘Sle establish tne gubielon date sndter chaion We 8M y~ ou neat of puiaburelevace he cumad oven cent stil non Ga speifi) Seaweed if Solve ances ee hen te dace “O" documt refering Wo am ral dclosre, wu, ethbion ar ale Somme with one ornate sich ecu ts,ssh cometion ric felag ebvous tra porn skied athe at P" docuneat bis prieto the nteaatioal ig datebut le than gr econ meaber of the same patent fa the pry dae its ac = tea faily Date ofthe actual completion ofthe Intemational seach 14-12-2017 Date of mailing of the international search report 14-12-2017 ‘Nae and mailing wiess of he ISAT Indian Patent Office Plot tlo.32) Sector Facsimile No. 4, Dwarka, ew Dethi-110075, ‘Anortes oflicee Sravanthi ‘Telephone No. +91~1125300200 Form PCTVISA/DI0 eacond sheet) (aay 2013)Tnternational applivation No, PCT/1B2017/058508 favion Pub.Date Family Pub. Date Us 2012221073 A 30-08-2012 EP 2473229 B. AU 2010291851 B2 Form PCTASA/ZI0 (patent family annex) Canny 2018)