EP3852662A1 - A device for performing a method of application of electrocautery for the thermal stimulation of vaginal mucosa - Google Patents

A device for performing a method of application of electrocautery for the thermal stimulation of vaginal mucosa

Info

Publication number
EP3852662A1
EP3852662A1 EP19800913.6A EP19800913A EP3852662A1 EP 3852662 A1 EP3852662 A1 EP 3852662A1 EP 19800913 A EP19800913 A EP 19800913A EP 3852662 A1 EP3852662 A1 EP 3852662A1
Authority
EP
European Patent Office
Prior art keywords
head
applicator
vaginal mucosa
electrocautery
handle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP19800913.6A
Other languages
German (de)
English (en)
French (fr)
Inventor
Radek NESPOR
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Compex sro
Original Assignee
Compex sro
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Compex sro filed Critical Compex sro
Publication of EP3852662A1 publication Critical patent/EP3852662A1/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1485Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00559Female reproductive organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00702Power or energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/0072Current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00696Controlled or regulated parameters
    • A61B2018/00767Voltage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0521Genital electrodes
    • A61N1/0524Vaginal electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/20Applying electric currents by contact electrodes continuous direct currents
    • A61N1/205Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/20Applying electric currents by contact electrodes continuous direct currents
    • A61N1/28Apparatus for applying thermoelectric currents

Definitions

  • This invention relates to a method of applying electrocautery and a gynaecological head
  • vaginal rejuvenation and incontinence.
  • the subject matter of the invention is a method of applying electrocautery for the
  • electrocautery device wherein the gynaecological head of the electrocautery device is
  • the grounding electrode of the source is connected to a patient’s skin to create contact between the two electrodes.
  • the principle of this invention is that the
  • non-metallic gynaecological head which is adapted for direct contact with the vaginal
  • mucosa is gradually inserted into vagina and pulled out with simultaneous direct
  • anterior and posterior vaginal mucosa is heated to 40-45°C and neocollagenesis is stimulated, i.e. the activation of fibroblasts producing collagen, the stimulation of cell division, and the renewal of the extracellular matrix.
  • the head which is adapted for direct contact with vaginal mucosa, comprises of an applicator in the form of a hollow plastic cylinder that enables its insertion into a handle, where it is sealed and secured in its working position. At its outer end, the applicator is connected to the tip of the shaped working electrode and closed by sealable lid.
  • a power supply cable passes through the interior of the applicator and the handle, wherein the power between the working electrode of the head and the grounding electrode is in the range of 0.5 to 10 W.
  • the working electrode can come in a number of shapes, namely a ring, a sector of a circle, or full circle.
  • the applicator can be secured with at least one O-ring in the connection with the handle and the lid.
  • An LED indicator is connected to the power supply cable in the upper part of the handle.
  • the handle with the internal lead-in cable can be connected to the direct current power source via the rotary connector.
  • the aim of the invention presented here is to improve symptoms of vaginal laxity as well as symptoms associated with atrophy, including painful or unsatisfactory sexual activity, with particular emphasis on stress incontinence, using thermal and/or electrical effects.
  • This invention can restore most of the vagina’s functions, including secretion, absorption, elasticity, and vaginal epithelium thickness (vaginal rejuvenation).
  • This invention ultimately revitalises and restores the elasticity and moisture of the vaginal mucosa: the passage of the direct current through the membranes leads to energy release as it collides with the molecules of the cells of the vaginal mucosa, causing the molecules in the absorbing tissue to vibrate. This results in an increase in the temperature of the vaginal mucosa.
  • the electrical current passing through the circuit causes the movement of the electrical charges that carries out the rejuvenation work.
  • Fig. 1 shows a side view of the gynaecological head
  • Fig. 2 shows the same in plan view
  • Fig. 3 in vertical section
  • Fig. 4 shows a detail of the positioning of the working electrode in the tip of the head
  • Fig. 5 shows the connection of the applicator of the head to its handle
  • Fig. 6 shows the detailed connection of the high voltage cable to the head.
  • the gynaecological head of the direct-current electrocautery device which is intended to treat the vaginal mucosa of a patient, is connected via its working electrode 5 to a direct current source whose grounding electrode is connected to the skin of the patient to make contact between these two electrodes.
  • the head which is adapted for direct contact with the vaginal mucosa, comprises the applicator 1 in the shape of a hollow cylinder made of plastic (a polyacetal copolymer, sold under the name Ertacetal C) with a length of 200 mm and diameter of 30 mm, insertable in a sealed manner into the handle 2, also made of Ertacetal) with a diameter of 30 mm, with the upper semi- spherical terminal, where the applicator 1 is fixed in a sealed manner in its working position using a rubber O-ring 7.
  • plastic a polyacetal copolymer, sold under the name Ertacetal C
  • An LED indicator 6 is connected in the upper part of the handle 2 in the area of the connection of the applicator 1 into the power supply cable 3.
  • the applicator 1 On its outer end, the applicator 1 is connected to the tip with a shaped brass gold-plated or steel (stainless steel) working electrode 5 in the form of a ring or a sector of a circle (or full circle) and is closed by a rounded sealed lid 4, made of Ertacetal.
  • a shaped brass gold-plated or steel (stainless steel) working electrode 5 in the form of a ring or a sector of a circle (or full circle) and is closed by a rounded sealed lid 4, made of Ertacetal.
  • a high-voltage power supply cable 3 passes through the inner cavity of the applicator 1 and the handle 2.
  • the handle 2 with the internal power supply cable 3 can be connected to a direct current source via the rotary connector 8.
  • the power output of the energy source between the working electrode of the head and the grounding electrode ranges from 0.5 to 10 W at a voltage of 3 to 5 kV.
  • the tip of the applicator 1 is in contact with the mucous membrane, though there is no discharge: the device immediately maintains the maximum determined current flowing through the tissue and accordingly regulates the voltage.
  • the current is 2 mA; for a power of 4 W, the maximum current is approximately 3 mA; for 6 W, the current is approximately 4 mA; and for 10 W the current is approximately 6 mA.
  • the gynaecological applicator 1 is connected to the instrument JETT Plasma Lift Medical (manufactured by COMPEX s.r.o. company), a patient is conductively connected to the instrument via the grounding electrode. Aqueous ultrasonic gel is applied to the end and surface of the applicator prior to the insertion of the applicator, thereby achieving good contact between the head electrode and the vaginal wall. The attending physician will insert the applicator into the patient's vagina, making contact between the functional surface of the applicator tip and the vaginal mucosa.
  • the treatment is carried out by repeatedly inserting and withdrawing the applicator 1, the current passing through the head being indicated by the LED indicator 6 in the handle body 2, and the physician can check the correct minimum insertion via the outer O-ring 7 on the applicator 1 body approximately 2 cm from its tip. This ensures that no discharge occurs prior to treatment since the tip is in constant contact with the mucosa.
  • the vaginal mucosa is stimulated by the electric current during the treatment, gradually affecting the front and rear walls of the vagina. The walls are heated to a temperature of about 45°C. At this temperature there are no destructive changes in the mucous membrane or in the mucosal tissue but neocollagenesis is stimulated, i.e.
  • the procedure is painless, does not require the administration of a local anaesthetic agent, and ensures the rejuvenation of the atrophic mucosa of the vagina. It is also suitable when local oestrogen vaginal creams cannot be used. It reduces or even almost completely prevents spontaneous leakage of urine and improves the sexual life of patients. List of reference marks

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Plasma & Fusion (AREA)
  • Otolaryngology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Cardiology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Electrotherapy Devices (AREA)
  • Materials For Medical Uses (AREA)
EP19800913.6A 2018-09-18 2019-09-18 A device for performing a method of application of electrocautery for the thermal stimulation of vaginal mucosa Withdrawn EP3852662A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CZ2018-483A CZ2018483A3 (cs) 2018-09-18 2018-09-18 Způsob aplikace elektrokauteru pro tepelnou stimulaci vaginální sliznice a zařízení pro uskutečňování tohoto způsobu
PCT/CZ2019/000047 WO2020057676A1 (en) 2018-09-18 2019-09-18 A device for performing a method of application of electrocautery for the thermal stimulation of vaginal mucosa

Publications (1)

Publication Number Publication Date
EP3852662A1 true EP3852662A1 (en) 2021-07-28

Family

ID=69636999

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19800913.6A Withdrawn EP3852662A1 (en) 2018-09-18 2019-09-18 A device for performing a method of application of electrocautery for the thermal stimulation of vaginal mucosa

Country Status (3)

Country Link
EP (1) EP3852662A1 (cs)
CZ (1) CZ2018483A3 (cs)
WO (1) WO2020057676A1 (cs)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA1327633C (en) * 1987-05-08 1994-03-08 Steven Bellofatto Medical instrument for therapy of hemorrhoidal lesions
EP2398548B1 (en) * 2009-02-17 2017-04-19 The Board Of Trustees Of The Leland Closure device
CZ2015333A3 (cs) * 2015-05-19 2016-11-02 Compex spol. s r.o. Přenosné zařízení, zejména pro elektrofulguraci a elektrodesikaci
US11020166B2 (en) * 2015-09-25 2021-06-01 Gyrus Acmi, Inc. Multifunctional medical device
US10039929B1 (en) * 2017-04-04 2018-08-07 BLT Holdings Limited Method and device for pelvic floor tissue treatment

Also Published As

Publication number Publication date
CZ308215B6 (cs) 2020-03-04
WO2020057676A4 (en) 2020-05-07
CZ2018483A3 (cs) 2020-03-04
WO2020057676A1 (en) 2020-03-26

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