WO2017217760A1 - Dispositif thérapeutique utilisant une électrode d'interfonctionnement d'endoscope - Google Patents

Dispositif thérapeutique utilisant une électrode d'interfonctionnement d'endoscope Download PDF

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Publication number
WO2017217760A1
WO2017217760A1 PCT/KR2017/006193 KR2017006193W WO2017217760A1 WO 2017217760 A1 WO2017217760 A1 WO 2017217760A1 KR 2017006193 W KR2017006193 W KR 2017006193W WO 2017217760 A1 WO2017217760 A1 WO 2017217760A1
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WO
WIPO (PCT)
Prior art keywords
electrode
endoscope
optical fiber
target cell
treatment device
Prior art date
Application number
PCT/KR2017/006193
Other languages
English (en)
Korean (ko)
Inventor
김성남
Original Assignee
(주)더스탠다드
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 (주)더스탠다드 filed Critical (주)더스탠다드
Priority to US16/310,174 priority Critical patent/US20190183563A1/en
Priority to CN201780037314.0A priority patent/CN109310861B/zh
Priority to EP17813583.6A priority patent/EP3470109B1/fr
Priority claimed from KR1020170074861A external-priority patent/KR102058904B1/ko
Publication of WO2017217760A1 publication Critical patent/WO2017217760A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/046—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for infrared imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
    • A61B1/044—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances for absorption imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/07—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements using light-conductive means, e.g. optical fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents

Definitions

  • the present invention relates to a therapeutic apparatus that interworks with an endoscope to electrically destroy target cells in the body.
  • electroporation refers to a therapeutic technique used to inject a target substance such as DNA into a cell.
  • the electroporation method is to apply a voltage to the cell membrane to form a perforation on the cell membrane, and to inject the target material through the hole.
  • the cell membrane is formed of lipids
  • the lipids when a high voltage is applied, the lipids may be directed to one side to form perforations in the cell membranes.
  • the perforation may be filled again according to the intensity of the applied voltage.
  • the case in which the perforation generated by the voltage is refilled over time is called reversible electroporation.
  • Irreversible electroporation is characterized by necrosis of cells by forming unrecoverable perforations in target cells.
  • Cells contain potassium ions (K + ) which are essential for regulating intracellular metabolism. If there is a perforation in the cell membrane, potassium ions are released out of the cell through the perforation. Cells whose potassium concentration is abnormal due to the leakage of potassium ions to the outside are necroticly received by receiving signals from cell membrane receptors to apoptosis. Cell suicide by such irreversible electroporation may be performed on abnormal cells such as cancer cells or malignant tumors.
  • K + potassium ions
  • An object of the present invention is to provide a therapeutic apparatus capable of performing irreversible electroporation in the body.
  • the present invention is an endoscope channel; And an electrode that can be inserted into the body through the endoscope channel, wherein the electrode destroys a target cell in the body through voltage application, and the electrode is configured to determine a degree of destruction of the target cell through impedance measurement. And an optical fiber and a second optical fiber.
  • the present invention is an endoscope channel; And a catheter that can be inserted into the body through an endoscope channel, wherein the catheter is a plurality of punctures at the end inserted into the body and a plurality of protrusions protruding from the catheter end through the perforations to penetrate target cells. It characterized in that it comprises an electrode.
  • an electrode capable of performing irreversible electroporation can accurately pick up target cells in the body in conjunction with an endoscope.
  • irreversible electroporation according to the present invention has less side effects due to treatment because it only necrosis target cells without affecting the tissue.
  • the treatment device according to the present invention can accurately check the degree of necrosis of the target cell by including a pair of optical fibers in the electrode.
  • the therapeutic apparatus according to the present invention has a configuration capable of confirming the degree of necrosis of the target cells in the apparatus, no separate test apparatus for confirming the degree of necrosis of the target cells is required. This reduces the hassle of removing the treatment device and inserting a separate test device to check the progress of the treatment during the treatment and increases the treatment efficiency.
  • FIG. 1 is an enlarged simplified view of the distal end of a treatment device according to an embodiment of the present invention.
  • FIG 2 is an enlarged simplified view of the distal end of a treatment device according to another embodiment of the present invention.
  • FIG. 3 is a simplified diagram of the electrode provided in the treatment device according to another embodiment of the present invention.
  • Figure 4 shows the optical fiber provided in the electrode according to an embodiment of the present invention.
  • FIG. 5 is a diagram illustrating the electrode illustrated in FIG. 2 in detail.
  • FIG. 6 is another view illustrating the electrode illustrated in FIG. 2 in detail.
  • 1 is an enlarged simplified view of the distal end of a treatment device according to an embodiment of the present invention.
  • 2 is an enlarged simplified view of the distal end of a treatment device according to another embodiment of the present invention.
  • the treatment apparatus is characterized in that (10) is disclosed.
  • Endoscopic channel 100 is inserted into the body to help the operator visually see the patient's body.
  • the endoscope channel 100 is a body that can be held by the user, an image acquisition unit (not shown) for capturing the body of the patient, a housing (not shown) into which the first electrode 200 can be inserted, and the patient to be photographed. It includes an image output unit for visually providing the body of the user.
  • the body of the endoscope channel 100 is formed in a shape that is easy for the user to hold and manipulate by hand, and a space is provided therein.
  • a space is provided therein.
  • the space inside the body there is a housing into which the first electrode 200 can be inserted, and an electric wire connecting the image acquisition unit and the image output unit.
  • the body When the endoscope channel 100 is inserted into the patient's body, the body protects the wires, the first electrode 200, and the like from the body fluid of the patient. Thus, the body must be able to withstand acidic fluids such as stomach acid. In addition, the body is a component that directly touches the patient's body and should not emit harmful chemicals. In order to satisfy the two conditions, the body may be made of a medical polymer material such as fluorocarbons, polyamides, polyesters, polyester elastomers, and the like.
  • the image acquisition unit is located at the end of the body to be inserted into the body.
  • various optical means capable of receiving an image by receiving light such as a lens or an end of an optical cable may be used.
  • the image acquisition unit may be further provided with a light emitting means for irradiating light toward the front of the body.
  • the housing is a space for accommodating the first electrode 200.
  • the housing has a diameter enough to allow the first electrode 200 to pass therethrough, and preferably has a diameter of 100 to 1000 ⁇ m.
  • the housing may also be made of medical polymer materials such as fluorocarbons, polyamides, polyesters, polyester elastomers, and the like.
  • the image output unit is a means for outputting the user to visually check the inside of the patient acquired by the image acquisition unit (not shown).
  • the image output unit may include a display unit for visual output, and may be in the form of a portable device that can be carried by a user or a fixed device such as a computer.
  • FIG. 3 is a simplified diagram of the electrode provided in the treatment device according to another embodiment of the present invention.
  • the first electrode 200 is a device for destroying target cells by applying a voltage to the target cells. Specifically, the first electrode 200 applies a high pressure to the target cell, thereby forming a perforation in the cell membrane made of lipid (lipid).
  • the series of processes that begins with applying a voltage to a target cell is called irreversible electroporation, and cell suicide by such irreversible electroporation is performed on abnormal cells such as cancer cells or malignant tumors. Can be.
  • the first electrode 200 according to the first embodiment may preferably have a pad shape.
  • the pad-shaped first electrode 200 is in close contact with the target cell 900 such as the stomach wall. Since the pad-shaped first electrode 200 is not inserted into the target cell 900, it does not cause cell damage due to insertion.
  • the first electrode 200 is inserted into the stomach wall, after the treatment, the first electrode 200 is inserted into the stomach wall, that is, the perforation remains. These perforations can be expanded by gastric acid and can cause other side effects such as gastric ulcers in the patient.
  • the first electrode 200 Since the first electrode 200 must be able to apply a voltage to the upper wall, it must be made of a material having high electrical conductivity. In addition, like the housing or the body, the first electrode 200 should also be able to withstand acidic fluids such as gastric acid and should not emit harmful chemicals. Therefore, the first electrode 200 may be preferably made of a metal material such as 316 stainless steel, Co-Cr alloy, or Ti alloy.
  • Figure 4 shows the optical fiber provided in the electrode according to an embodiment of the present invention.
  • the first electrode 200 includes a first optical fiber 210 and a second optical fiber 220 to confirm the degree of destruction of the target cell through impedance measurement. That is, the first optical fiber 210 and the second optical fiber 220 may be configured on at least one surface of the first electrode 200, respectively.
  • the first optical fiber 210 and the second optical fiber 220 measure how destroyed the target cells by applying a voltage through a near infrared spectroscopy system. Near-infrared rays are emitted from the first optical fiber 210 toward the target cells. The target cell absorbs the emitted near infrared rays, and the degree of absorption of the near infrared rays may vary depending on the structure of the cells. Near-infrared rays passing through the target cells are detected in the second optical fiber 220.
  • the user may compare the intensity of the near infrared rays emitted by the first optical fiber 210 and the intensity of the near infrared rays detected by the second optical fiber 220 after passing through the target cell to determine how much cell destruction has progressed.
  • impedance is a measure for evaluating the degree of absorption of near infrared rays.
  • Infrared radiation is less absorbed by water and blood molecules and can penetrate deep into living tissues.
  • near infrared rays are advantageous over waves with other wavelength ranges in identifying cell disruption.
  • the wavelength range of the wave which can be used as near infrared rays is preferably 0.75 to 3 ⁇ m. If the wavelength of the wave is less than 0.75 ⁇ m, the cell can be mutated by the wave.If the wavelength of the wave exceeds 3 ⁇ m, the wave is hardly absorbed by the cell, so the wave is absorbed by the cell according to the cell structure. It can be difficult to do.
  • the method of confirming the degree of destruction of target cells using near infrared rays follows the Beer Lambert law as follows.
  • the voltage applied to the target cell by the first electrode 200 to perform irreversible electroporation may be 1 KV or more.
  • a voltage of less than 1 KV is applied to the target cell, reversible electroporation may occur, causing the perforation on the target cell membrane to be blocked again.
  • the therapeutic method of the present invention that forms a permanent perforation in the cell membrane of the target cell and necrotic the cell cannot be performed.
  • the first electrode 200 may have a fixed shaft 230 connected to the endoscope channel 100 to rotate about the fixed shaft 230.
  • the first electrode 200 may be oriented parallel to the housing 130. This has the effect of reducing the diameter required for the housing 130 for the first electrode 200 to pass through.
  • the first electrode 200 may be rotated to conform to the external curvature of the target cell. Since the target cells inside the human body often have a curved shape, the electrode rotating to the outer curve of the target cell can be more tightly adhered to the curved target cells, which increases the voltage application efficiency.
  • the first optical fiber 210 and the second optical fiber 220 may be provided with optical fiber holes to improve impedance measurement accuracy.
  • the optical fiber hole allows the near-infrared ray emitted from the first optical fiber 210 to move directly to the second optical fiber 220 without bypassing, thereby reducing an error in measuring the degree of target cell destruction that may occur due to the bypass of the near-infrared rays.
  • FIG. 5 is a view illustrating in detail the electrode 200 illustrated in FIG. 2.
  • the second embodiment includes an endoscope channel; And a catheter that can be inserted into the body through an endoscope channel, wherein the catheter is a plurality of punctures at the end inserted into the body and a plurality of protrusions protruding from the catheter end through the perforations to penetrate target cells.
  • a therapeutic device comprising an electrode.
  • the configuration of the endoscope channel 100 of the device according to the second embodiment of the present invention is substantially the same as the endoscope channel 100 according to the first embodiment. Therefore, hereinafter, the catheter 300 according to the second embodiment and the second electrode 320 different from the first electrode will be described in detail.
  • the treatment device includes a catheter 300.
  • the catheter 300 includes a plurality of second electrodes 320 protruding from the end of the catheter 300 through the puncturing part 310 and the puncturing part 310 at the end inserted into the body and penetrating the target cell. It includes.
  • the catheter 300 should be able to withstand acidic fluids such as stomach acid and should not emit harmful chemicals. Accordingly, the catheter 300 may be made of medical polymer materials such as fluorocarbons, polyamides, polyesters, polyester elastomers, and the like.
  • a perforation portion 310 is present at one end of the catheter 300.
  • the puncturing part 310 performs a passage function through which the second electrode 320 protrudes from the catheter 300. Since the number of the perforations 310 is not limited, a person skilled in the art can adjust the number as needed.
  • the second electrode 320 is inserted into a target cell to apply a voltage to the target cell. Therefore, the second electrode 320 may be manufactured in the form of a probe to facilitate insertion. Since the second electrode 320 should be able to apply a voltage to the upper wall, it should be made of a material having high electrical conductivity. In addition, like the catheter 300, the second electrode 320 should also be able to withstand acidic fluids such as gastric acid and should not emit harmful chemicals. Therefore, the second electrode 320 may be preferably made of a metal material such as 316 stainless steel, Co-Cr alloy, or Ti alloy.
  • the voltage applied to the target cell by the second electrode 320 according to the second embodiment of the present invention to perform irreversible electroporation may be 1 KV or more.
  • a voltage of less than 1 KV is applied to the target cell, reversible electroporation may occur, causing the perforation on the target cell membrane to be blocked again.
  • the therapeutic method of the present invention that forms a permanent perforation in the cell membrane of the target cell and necrotic the cell cannot be performed.
  • a plurality of second electrodes 320 may also exist.
  • the number of second electrodes 320 may be equal to the number of perforations 310.
  • Each of the plurality of second electrodes 320 includes both an anode and a cathode in the second electrode 320.
  • an electric field is generated between the anode and the cathode in the second electrode 320.
  • the voltage is applied to the target cell by this electric field. Since each of the second electrodes 320 of the present invention includes both the positive electrode and the negative electrode, even if some second electrodes 320 fail, treatment may be continuously performed by the second second electrode 320.
  • the second electrode 320 according to the second embodiment of the present invention may also include a first optical fiber and a second optical fiber for checking the degree of destruction of the target cell through impedance measurement. Matters relating to the first optical fiber and the second optical fiber are the same as those of the first optical fiber 210 and the second optical fiber 220 according to the first embodiment.
  • At least one protrusion may be formed on the second electrode 320 in a curved shape. At least one of the protrusions has a surface in the form of a circle or ellipse.
  • the second electrode includes at least one hole penetrating the second electrode in at least one direction. At least one hole may be configured to correspond to at least one protrusion position. At least one hole may be configured in a circle or ellipse form.
  • the endoscope channel 100 When the endoscope channel 100 is inserted into the body of the patient, even when the second electrode 320 is inserted into the tissue, the target cell, or the stomach, the tissue, the target cell, the stomach, and the like continue to exercise. As a result, the second electrode 320 may not be inserted into the tissue, the target cell, the stomach, or the like, or may fall out again by movement.
  • the second electrode 320 when at least one protrusion is formed on the surface of the second electrode 320 or at least one hole is formed on the second electrode 320, when the surface contact surface of the second electrode 320 becomes large, the second electrode 320 is increased. Can increase the surface adhesion. When the surface contact surface of the second electrode 320 is inserted in a tissue, a target cell, a stomach, or the like in an enlarged state, the insertion binding force is increased, thereby increasing the treatment efficiency.
  • FIG. 6 is another view illustrating the electrode illustrated in FIG. 2 in detail.
  • a plurality of third electrodes 330 of the present invention are present, and the number of third electrodes 330 may be equal to the number of perforations 310. .
  • Each of the plurality of third electrodes 330 is separated into at least one positive electrode (+) electrode and negative electrode ( ⁇ ) electrode. That is, each of the third electrodes 330 may be configured such that the anode electrode and the cathode electrode are parallel to each other. When a plurality of positive electrode (+) electrode and negative electrode ( ⁇ ) electrode are arranged in parallel with each other, the voltage application efficiency can be improved.
  • the third electrode 330 having a plurality of positive electrode and negative electrode arranged in parallel with each other is inserted into a tissue, a target cell, a stomach, or the like
  • a current flows through the third electrode 330
  • An electric field is generated between the positive electrode and the negative electrode.
  • the voltage is applied to the target cell by this electric field.
  • the positive electrode (+) electrode and the negative electrode (-) electrode configured to be separated in parallel to each other may be formed with at least one protrusion in a curved surface.
  • At least one of the protrusions has a surface in the form of a circle or ellipse. At least one hole penetrating in at least one direction is formed in the positive electrode and the negative electrode. At least one hole may be configured to correspond to at least one protrusion position. At least one hole may be configured in a circle or ellipse form.
  • At least one protrusion is formed on the surface of the positive electrode and the negative electrode, or at least one hole is formed, so that when the surface contact surface of the positive electrode and the negative electrode becomes large, )
  • the surface adhesion of the electrode and the cathode (-) electrode can be improved.

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  • Engineering & Computer Science (AREA)
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Abstract

La présente invention concerne un dispositif thérapeutique caractérisé en ce qu'il comprend : un canal d'endoscope; et une électrode qui peut être insérée dans un corps humain à travers le canal d'endoscope, l'électrode détruisant une cellule cible dans le corps humain par application de tension et comprend une première fibre optique et une seconde fibre optique pour confirmer le degré de destruction de la cellule cible par mesure d'impédance. En outre, la présente invention concerne un dispositif thérapeutique utilisant une électrode d'interfonctionnement d'endoscope, le dispositif thérapeutique étant caractérisé en ce qu'il comprend: un canal d'endoscope; et un cathéter qui peut être inséré dans un corps humain à travers le canal d'endoscope, le cathéter comprenant une partie perforée prévue sur une extrémité de celui-ci, qui est insérée dans le corps humain, et une pluralité d'électrodes qui peuvent faire saillie à partir de l'extrémité du cathéter à travers la partie perforée et pénétrer dans une cellule cible.
PCT/KR2017/006193 2016-06-14 2017-06-14 Dispositif thérapeutique utilisant une électrode d'interfonctionnement d'endoscope WO2017217760A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US16/310,174 US20190183563A1 (en) 2016-06-14 2017-06-14 Therapeutic device employing endoscope-interworking electrode
CN201780037314.0A CN109310861B (zh) 2016-06-14 2017-06-14 利用内窥镜联动式电极的治疗装置
EP17813583.6A EP3470109B1 (fr) 2016-06-14 2017-06-14 Dispositif thérapeutique utilisant une électrode d'interfonctionnement d'endoscope

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR10-2016-0074045 2016-06-14
KR20160074045 2016-06-14
KR1020170074861A KR102058904B1 (ko) 2016-06-14 2017-06-14 내시경 연동형 전극을 이용한 치료장치
KR10-2017-0074861 2017-06-14

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WO2017217760A1 true WO2017217760A1 (fr) 2017-12-21

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6235023B1 (en) * 1995-08-15 2001-05-22 Rita Medical Systems, Inc. Cell necrosis apparatus
US20070232871A1 (en) * 2006-04-03 2007-10-04 Edward Sinofsky Method and system for determining tissue properties
KR101198690B1 (ko) * 2009-11-09 2012-11-12 우먼스캐어 주식회사 피부관리용 전극장치와 이를 구비한 피부관리기
US20140081255A1 (en) * 2000-07-25 2014-03-20 Angiodynamics, Inc. Method and Apparatuses for Tissue Treatment
KR20150115223A (ko) * 2014-04-03 2015-10-14 주식회사 원메드텍 영상촬영이 가능한 고주파 카테터

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6235023B1 (en) * 1995-08-15 2001-05-22 Rita Medical Systems, Inc. Cell necrosis apparatus
US20140081255A1 (en) * 2000-07-25 2014-03-20 Angiodynamics, Inc. Method and Apparatuses for Tissue Treatment
US20070232871A1 (en) * 2006-04-03 2007-10-04 Edward Sinofsky Method and system for determining tissue properties
KR101198690B1 (ko) * 2009-11-09 2012-11-12 우먼스캐어 주식회사 피부관리용 전극장치와 이를 구비한 피부관리기
KR20150115223A (ko) * 2014-04-03 2015-10-14 주식회사 원메드텍 영상촬영이 가능한 고주파 카테터

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3470109A4 *

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