WO2019198097A1 - Transvaginal non-invasive ablation of polycystic ovarian disease ( pcos) and endometriotic ovarian cysts and device thereof to carry out said function - Google Patents

Transvaginal non-invasive ablation of polycystic ovarian disease ( pcos) and endometriotic ovarian cysts and device thereof to carry out said function Download PDF

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Publication number
WO2019198097A1
WO2019198097A1 PCT/IN2019/050289 IN2019050289W WO2019198097A1 WO 2019198097 A1 WO2019198097 A1 WO 2019198097A1 IN 2019050289 W IN2019050289 W IN 2019050289W WO 2019198097 A1 WO2019198097 A1 WO 2019198097A1
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Prior art keywords
ovarian
needle
pcos
monopolar
cysts
Prior art date
Application number
PCT/IN2019/050289
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French (fr)
Inventor
Aniruddha MALPANI
Original Assignee
Malpani Aniruddha
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Publication date
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Publication of WO2019198097A1 publication Critical patent/WO2019198097A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4318—Evaluation of the lower reproductive system
    • A61B5/4325—Evaluation of the lower reproductive system of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters

Definitions

  • PCOS polycystic ovarian disease
  • This invention relates to Transvaginal Non-invasive Ablation of polycystic ovarian disease (PCOS) and endometriotic ovarian cysts and a device there of to carry out the same.
  • PCOS polycystic ovarian disease
  • PCOS is a common gynecologic disease which causes infertility and irregular periods . This device allows gynecologists to treat selected patients with PCOS using ultrasound guidance.
  • Endometriosis is a common gynecologic disease which causes pelvic pain and infertility. Some of these patients have cysts in their ovaries, called endometriomas or chocolate cysts. This device allows the doctor to treat these endometriotic cysts.
  • Vaginal ultrasound scanning is a well established diagnostic technology used for visualising ovarian lesions, and is used routinely in clinical practice to make the diagnosis of PCOD and endometriotic cysts.
  • Vaginal ultrasound guided egg collection is a standard medical treatment, which is used when doing IVF.
  • a hollow 33 cm long needle is inserted under ultrasound guidance, to collect the eggs from a superovulated ovary, by aspirating the follicular fluid from mature ovarian follicles.
  • PCOS is treated using operative laparoscopy. During this surgical intervention, the excess ovarian stroma in these patients is ablated under laparoscopic visualisation, using electrical current.
  • Vaginal ultrasound scanning is also used to make the diagnosis of endometriomas.
  • Operative laparoscopy is an expensive surgical intervention, which needs to be performed in the Operation Room. It requires hospitalisation, and involves the risk associated with any surgical intervention.
  • the object of the instant invention is to provide a device which allows the gynecologist to treat the diseases under ultrasound guidance. This is much quicker, and less expensive. It is also safer, since it can be done as an office procedure.
  • FIG. 1 Vaginal ultrasound transducer probe with needle guide attached.
  • the monopolar or bipolar wire electrode protrudes from the distal end of the double lumen needle attached to the vaginal ultrasound probe.
  • Figure 3 Shows the Schematic and illustration of vaginal ultrasound guided ablation of ovarian cysts using the monopolar or bipolar wire electrode in patients with polycystic ovarian disease ( PCOD)
  • Figure 4 Shows the schematic and illustration of a vaginal ultrasound guide ablation of chocolate cysts using the monopolar or bipolar wire electrode in patients with endometriosis
  • the device consists of a double lumen 33 cm long, 16 G needle, along with a 34 cm long insulated monopolar or bipolar electrode wire , which passes through the lumen of the needle.
  • the electrode is connected to a standard surgical electrical cautery, which is activated with a standard foot-switch (fig.l and 2) When used for treating PCOS
  • Ablation of the ovarian stroma using electric cautery is standard medical treatment today.
  • the gynecologist needs to perform an operative laparoscopy, so that he can visualise the ovary in order to deliver the electrical energy precisely into the ovarian stroma.
  • This device allows the gynecologist to accomplish the same goal using ultrasound guidance.
  • the device is inserted into the ovary under ultrasound guidance, using a standard biopsy probe guide. Once the tip of the needle can be seen to be positioned properly in the ovarian stroma, the 34 cm long insulated monopolar or bipolar electrode in inserted into the ovarian tissue, through the central lumen of the needle, and the electrical current activated. This ablates the ovarian stroma, thus treating it.
  • Ablation of the cyst wall using electric cautery is standard medical treatment today. At present the gynecologist needs to perform an operative laparoscopy, so that he can visualise the cyst, and deliver the electrical energy precisely to ablate the cyst wall. This device allows the gynecologist to accomplish the same goal using ultrasound guidance.
  • the device is inserted into the ovary under ultrasound guidance, using a standard biopsy probe guide. After it is positioned properly, the cyst fluid is drained if needed, by connecting the suction port to a vacuum pump. Once the tip of the needle is in contact with the cyst wall, the 34 cm long insulated monopolar or bipolar electrode wire is inserted into the ovarian tissue, through the central lumen of the needle, and the electrical current activated. This ablates the cyst wall of the endometrioma, thus treating it.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Surgical Instruments (AREA)

Abstract

The combination of a thin specially designed insulated bipolar electrosurgical electrode wire capable of being passed through a custom designed double lumen needle which allows the surgeon to deliver the electrical energy to the diseased ovarian tissue transvaginally. This makes this medical device unique, because it is now possible to do the procedure using a minimally invasive technique, without having to subject the patient to surgical intervention

Description

Title of the invention:
Transvaginal Non-invasive Ablation of polycystic ovarian disease ( PCOS) and endometriotic ovarian cysts and device thereof to carry out said function
Field of Invention:
This invention relates to Transvaginal Non-invasive Ablation of polycystic ovarian disease ( PCOS) and endometriotic ovarian cysts and a device there of to carry out the same.
Prior Arts:
PCOS is a common gynecologic disease which causes infertility and irregular periods . This device allows gynecologists to treat selected patients with PCOS using ultrasound guidance.
Endometriosis is a common gynecologic disease which causes pelvic pain and infertility. Some of these patients have cysts in their ovaries, called endometriomas or chocolate cysts. This device allows the doctor to treat these endometriotic cysts.
Vaginal ultrasound scanning is a well established diagnostic technology used for visualising ovarian lesions, and is used routinely in clinical practice to make the diagnosis of PCOD and endometriotic cysts.
Vaginal ultrasound guided egg collection is a standard medical treatment, which is used when doing IVF. A hollow 33 cm long needle is inserted under ultrasound guidance, to collect the eggs from a superovulated ovary, by aspirating the follicular fluid from mature ovarian follicles.
Conventionally, PCOS is treated using operative laparoscopy. During this surgical intervention, the excess ovarian stroma in these patients is ablated under laparoscopic visualisation, using electrical current.
Vaginal ultrasound scanning is also used to make the diagnosis of endometriomas.
Conventionally, the walls of these cysts are ablated through an operative laparoscopy using electrical current.
Problems in the prior arts:
Operative laparoscopy is an expensive surgical intervention, which needs to be performed in the Operation Room. It requires hospitalisation, and involves the risk associated with any surgical intervention.
Object of the invention:
The object of the instant invention is to provide a device which allows the gynecologist to treat the diseases under ultrasound guidance. This is much quicker, and less expensive. It is also safer, since it can be done as an office procedure. Summary of the Invention:
The combination of a thin specially designed insulated monopolar or bipolar electrosurgical electrode capable of being passed through a custom designed double lumen needle which allows the surgeon to deliver the electrical energy to the diseased ovarian tissue transvaginally. This is what makes this medical device unique, because it is now possible to do the procedure using a minimally invasive technique, without having to subject the patient to surgical intervention.
Brief description of the Drawings:
The aspects and the advantages of the embodiments described herein will become more readily apparent by reference to the following detailed description when taken in conjunction with the following non limiting drawings wherein:
Figure !: Vaginal ultrasound transducer probe with needle guide attached. The monopolar or bipolar wire electrode protrudes from the distal end of the double lumen needle attached to the vaginal ultrasound probe.
Figure imgf000004_0001
Figure 3: Shows the Schematic and illustration of vaginal ultrasound guided ablation of ovarian cysts using the monopolar or bipolar wire electrode in patients with polycystic ovarian disease ( PCOD)
Figure 4: Shows the schematic and illustration of a vaginal ultrasound guide ablation of chocolate cysts using the monopolar or bipolar wire electrode in patients with endometriosis
Detailed Description:
The device consists of a double lumen 33 cm long, 16 G needle, along with a 34 cm long insulated monopolar or bipolar electrode wire , which passes through the lumen of the needle. The electrode is connected to a standard surgical electrical cautery, which is activated with a standard foot-switch (fig.l and 2) When used for treating PCOS
Ablation of the ovarian stroma using electric cautery is standard medical treatment today. At present the gynecologist needs to perform an operative laparoscopy, so that he can visualise the ovary in order to deliver the electrical energy precisely into the ovarian stroma. This device allows the gynecologist to accomplish the same goal using ultrasound guidance.
The device is inserted into the ovary under ultrasound guidance, using a standard biopsy probe guide. Once the tip of the needle can be seen to be positioned properly in the ovarian stroma, the 34 cm long insulated monopolar or bipolar electrode in inserted into the ovarian tissue, through the central lumen of the needle, and the electrical current activated. This ablates the ovarian stroma, thus treating it.
When used for treating endometriomas
Ablation of the cyst wall using electric cautery is standard medical treatment today. At present the gynecologist needs to perform an operative laparoscopy, so that he can visualise the cyst, and deliver the electrical energy precisely to ablate the cyst wall. This device allows the gynecologist to accomplish the same goal using ultrasound guidance.
The device is inserted into the ovary under ultrasound guidance, using a standard biopsy probe guide. After it is positioned properly, the cyst fluid is drained if needed, by connecting the suction port to a vacuum pump. Once the tip of the needle is in contact with the cyst wall, the 34 cm long insulated monopolar or bipolar electrode wire is inserted into the ovarian tissue, through the central lumen of the needle, and the electrical current activated. This ablates the cyst wall of the endometrioma, thus treating it.
The present invention is not limited to the above-described embodiments, and various alterations, modifications, and / or alternative applications of the invention may be possible, if desired, without departing from the scope and sprit of the invention, which can be read from the entire specification. All these possible alterations, modifications, and /or alternative applications of the invention are also intended to be within technical scope of the present invention.

Claims

Claims:
1. A device for carrying out Transvaginal Non-invasive Ablation of polycystic ovarian disease ( PCOS) and endometriotic ovarian cysts comprising: a combination of a thin specially designed insulated monopolar or bipolar eiectrosurgical wire electrodes passing through an custom designed double lumen needle which allows the surgeon to deliver the capable electrical energy to the diseased ovarian tissue transvaginaliy .
2. A device as claimed in claim 1 wherein a foot switch is provided to switch on the current to pass through the electrodes.
3. A device for carrying out Transvaginal Non-invasive Ablation of polycystic ovarian disease ( PCOS) and endometriotic ovarian cysts substantially as hereinbefore described with reference to the accompanying drawings.
4. A method of ablating the ovarian stroma using ultrasound guidance comprises the steps of inserting the device of any of the preceding claims into the ovary under ultrasound guidance using a standard biopsy probe guide, positioning the tip of the needle properly in the ovarian stroma, inserting into the ovarian tissue the 34 cm long insulated monopolar or bipolar electrode through the central lumen of the needle, and activating the electrical current.
5. A method of ablating the cyst wall using electric cautery using ultrasound guidance comprises the steps of inserting the device of any of the preceding claims into the ovary under ultrasound guidance using a standard biopsy probe guide, positioning it properly draining the cyst fluid if needed by connecting a vacuum pump to the suction port, contacting the tip of the needle with the cyst wall , inserting into the ovarian tissue the 34 cm long insulated monopolar or bipolar electrode through the central lumen of the needle, and activating the electrical current.
Dated this 9th April 2019
PCT/IN2019/050289 2018-04-10 2019-04-09 Transvaginal non-invasive ablation of polycystic ovarian disease ( pcos) and endometriotic ovarian cysts and device thereof to carry out said function WO2019198097A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821013617 2018-04-10
IN201821013617 2018-04-10

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4877033A (en) * 1988-05-04 1989-10-31 Seitz Jr H Michael Disposable needle guide and examination sheath for transvaginal ultrasound procedures
AU731815B2 (en) * 1997-07-18 2001-04-05 Gyrus Medical Limited An electrosurgical instrument
US20030216759A1 (en) * 1998-12-08 2003-11-20 Vascular Control Systems, Inc. Devices and methods for occlusion of the uterine arteries
US7520856B2 (en) * 1999-09-17 2009-04-21 University Of Washington Image guided high intensity focused ultrasound device for therapy in obstetrics and gynecology
EP3057545A1 (en) * 2013-10-18 2016-08-24 Ziva Medical, Inc. Methods and systems for the treatment of polycystic ovary syndrome

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4877033A (en) * 1988-05-04 1989-10-31 Seitz Jr H Michael Disposable needle guide and examination sheath for transvaginal ultrasound procedures
AU731815B2 (en) * 1997-07-18 2001-04-05 Gyrus Medical Limited An electrosurgical instrument
US20030216759A1 (en) * 1998-12-08 2003-11-20 Vascular Control Systems, Inc. Devices and methods for occlusion of the uterine arteries
US7520856B2 (en) * 1999-09-17 2009-04-21 University Of Washington Image guided high intensity focused ultrasound device for therapy in obstetrics and gynecology
EP3057545A1 (en) * 2013-10-18 2016-08-24 Ziva Medical, Inc. Methods and systems for the treatment of polycystic ovary syndrome

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