WO2019050310A1 - Dispositif d'électrode de type aiguille pour l'électroporation irréversible à travers un endoscope - Google Patents

Dispositif d'électrode de type aiguille pour l'électroporation irréversible à travers un endoscope Download PDF

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Publication number
WO2019050310A1
WO2019050310A1 PCT/KR2018/010448 KR2018010448W WO2019050310A1 WO 2019050310 A1 WO2019050310 A1 WO 2019050310A1 KR 2018010448 W KR2018010448 W KR 2018010448W WO 2019050310 A1 WO2019050310 A1 WO 2019050310A1
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WO
WIPO (PCT)
Prior art keywords
electrode
needle
catheter
cathode
anode
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Application number
PCT/KR2018/010448
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English (en)
Korean (ko)
Inventor
이재민
이홍식
전훈재
최혁순
김은선
금보라
김승한
유인경
Original Assignee
고려대학교산학협력단
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.)
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Application filed by 고려대학교산학협력단 filed Critical 고려대학교산학협력단
Priority claimed from KR1020180106541A external-priority patent/KR102180645B1/ko
Publication of WO2019050310A1 publication Critical patent/WO2019050310A1/fr

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    • 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
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light

Definitions

  • the present invention relates to a needle-like electrode device for irreversible electric piercing through an endoscope, and more particularly to a needle-like electrode device in which two electrodes, an anode and a cathode, are arranged on a single needle, To a needle-like electrode apparatus for irreversible electrical piercing through an electrode.
  • the irreversible electrosurgery is a new treatment that induces cell necrosis with multiple holes in the cell membrane using an electrode that delivers a high voltage of up to 3 kV into the tumor. It is a therapy that induces necrosis by inserting it in vitro and then applying a high voltage electric pulse to cause fine holes in the cell wall of the tissue in the gap between the electrodes. This treatment induces cell death by passing a pulsed electric pulse through the tumor at millions of times per second to induce microscopic pores in the cell membrane.
  • a needle-like electrode for irreversible electrical piercing through an endoscope including a needle electrode moving along a catheter and an interior of the catheter and protruding forward at a catheter end as the handle is driven, the needle electrode comprising: a needle; An anode electrode and a cathode electrode spaced apart from each other by a predetermined distance on a needle; At least one insulating portion disposed adjacent to the anode electrode and the cathode electrode along the needle to electrically separate the anode electrode and the cathode electrode; And cathode and cathode lines connected to the anode and cathode electrodes, respectively, extending backward along the catheter and the body.
  • At least one of the anode electrode and the cathode electrode may be formed in a polygonal shape so as to widen the contact area along the circumferential direction.
  • the insulating portion includes a fixed insulating portion disposed between the anode electrode and the cathode electrode; And a variable insulation portion disposed at the rear of the fixed insulation portion to variably adjust an exposed area of the anode electrode and the rear electrode of the cathode electrode.
  • a catheter comprising: a flexible catheter inserted according to a minimally invasive procedure connected along one direction; a needle inserted along the inside of the catheter and projecting forward from the catheter end according to the driving of the handle, A needle electrode of a needle-like electrode which includes an electrode and induces the activity of a beta cell responsible for insulin secretion of the pancreas as a stimulus of light to promote insulin secretion in a diabetic patient; An optical fiber attached to the needle; And a protective film for protecting the optical fiber, wherein the protective film is formed with at least one incision along one direction so that a region of light provided from the optical fiber is provided to the pancreas.
  • the light provided through the optical fiber may be formed of a red wavelength (RED) of 600 nm or a near-infrared ray of 800 nm.
  • RED red wavelength
  • the needle-like electrode for irreversible electric perforation through the endoscope according to the present invention can be inserted into the body through the endoscopic procedure by disposing the cathode and the anode respectively on one needle so that the organ such as the pancreas, It is possible to perform necrosis by inducing fine holes in the cell wall of the tissue at intervals between the electrodes by applying an electric pulse.
  • FIG. 1 is an operational state view of a needle-like electrode device having a needle-like electrode for irreversible electric piercing through an endoscope according to an embodiment of the present invention.
  • FIG. 2 is a view illustrating various embodiments of a cross-sectional shape of a needle electrode of a needle-like electrode for irreversible electric drilling through an endoscope according to an embodiment of the present invention.
  • FIG 3 is an operational view of an insulating portion of a needle electrode of a needle-like electrode for irreversible electric perforation through an endoscope according to an embodiment of the present invention.
  • FIG. 4 is a view of a needle-like electrode for promoting insulin secretion in a diabetic patient for irreversible electroporation through an endoscope according to another embodiment of the present invention.
  • 5 to 7 are experimental examples in which irreversible electrosurgery through an endoscope according to an embodiment of the present invention is applied to a livestock.
  • &quot when an element is referred to as " including " an element, it is understood that the element may include other elements as well, without departing from the other elements unless specifically stated otherwise. Also, throughout the specification, the term " on " means located above or below a target portion, and does not necessarily mean that the target portion is located on the upper side with respect to the gravitational direction.
  • FIG. 1 is an operational state view of a needle-like electrode device having a needle-like electrode for irreversible electric piercing through an endoscope according to an embodiment of the present invention.
  • a needle-like electrode device 10 having a needle-like electrode for irreversible electric piercing includes a hollow body 110, The catheter 130 and the catheter 130 that are connected to the other end of the handle 120 and the body 110 and are connected along one direction to be inserted according to the minimally invasive procedure, And a needle electrode 140 protruding forward from the end of the catheter 130 according to driving of the catheter 130.
  • the hollow body 110, the handle 120 and the flexible material catheter 130 described above are connected to the needle electrode 140 through manipulation of the handle connected to the electrode on the inner skin of the flexible catheter 130, A detailed description of the needle electrode 140 except for the needle electrode 140 will be omitted.
  • Fig. 2 shows various embodiments of the cross-sectional shape of a needle electrode of a needle-like electrode for irreversible electric piercing through an endoscope according to an embodiment of the present invention.
  • Fig. 3 is a cross- Fig. 7 is an operational view of the insulating portion of the needle electrode of the needle-like electrode for perforation.
  • the needle electrode 140 according to the embodiment of the present invention includes a needle 141, an anode electrode 142a and a cathode electrode 142b, an insulating portion 143, (144).
  • the needle 141 is inserted into the catheter 130 and protrudes forward according to an operation part provided on the handle 120.
  • the anode electrode 142a and the cathode electrode 142b are arranged along the circumferential direction of the needle 141 and spaced apart from the needle at a predetermined interval.
  • the anode electrode 142a and the cathode electrode 142b may be formed in a circular shape or may be formed in a polygonal shape so that the contact area increases along the circumferential direction.
  • the contact area may be formed in a wrinkled shape.
  • the star-shaped polygonal shape is described as an example in the present embodiment, it may be formed in various shapes to increase the contact area.
  • the cross-sectional shape of the needle 141 may be formed in a polygonal shape corresponding to the shapes of the anode electrode 142a and the cathode electrode 142b.
  • the amount of internal charge can be increased. Since the effect of irreversible electrosurgery is proportional to the electric field externally applied, this electric field can increase the effectiveness of irreversible electrosurgery in proportion to the number of free electrons that the metal possesses, that is, the amount of charge.
  • the contact force with the microvessels can be increased, thereby maximizing the effect of irreversible electrical punching.
  • the insulating portion 143 is disposed adjacent to the anode electrode 142a and the cathode electrode 142b along the needle and electrically separates the anode electrode 142a and the cathode electrode 142b from each other.
  • the insulating portion 143 may be fixedly disposed on the neighboring anode electrode 142a and cathode electrode 142b, respectively, as shown in FIG. 3A.
  • the insulating portion 143 may be provided as a fixed insulating portion 143a and a variable insulating portion 143b.
  • the fixed insulating portion 143a is disposed between the anode electrode 142a and the cathode electrode 142b located at the end of the needle 141.
  • variable insulation portion 142b is disposed at the rear of the cathode electrode 142b and the syllable edge portion 143 is disposed adjacent to the anode electrode 142a and the cathode electrode 142b along the needle to form the anode electrode 142a and the cathode electrode 142b, (142b), and at least one of them is provided.
  • the insulating portion 143 may be fixedly disposed on the neighboring anode electrode 142a and cathode electrode 142b, respectively, as shown in FIG. 3A.
  • the insulating portion 143 may be provided as a fixed insulating portion 143a and a variable insulating portion 143b.
  • the fixed insulating portion 143a is disposed between the anode electrode 142a and the cathode electrode 142b located at the end of the needle 141.
  • the variable insulation portion 142b is disposed behind the cathode electrode 142b and can be variably moved toward the cathode electrode 142b so that the exposed area of the cathode electrode 142b disposed at the rear can be variably adjusted.
  • the variable insulation portion 142b maximizes the effect of the irreversible electric perforation by allowing the amount of the internal charge to be further accommodated by variably adjusting the exposed area of the electrode, thereby increasing the exposed area of the electrode and exposing the electric field to the tissue By increasing the frequency that can be done, the therapeutic effect can be greatly increased.
  • the anode electrode 142a is positioned at the end of the needle 141, but the cathode electrode 142b may be positioned at the end of the needle 141, and the arrangement method thereof is not limited thereto .
  • the positive and negative electrodes 144 are coupled to the anode electrode 142a and the cathode electrode 142b respectively and extend backward along the catheter 130 and the body 110.
  • the cathode line and the cathode line 144 may be connected to a generator for irreversible electric drilling to form electric pulses at the anode electrode 142a and the cathode electrode 142b.
  • FIG. 4 is a view of a needle-like electrode for promoting insulin secretion in a diabetic patient for irreversible electroporation through an endoscope according to another embodiment of the present invention.
  • a needle-like electrode for promoting insulin secretion in a diabetic patient for irreversible electrical perforation includes a flexible material inserted according to a minimally invasive procedure connected along one direction And a needle electrode inserted along the inside of the catheter and inside the catheter to protrude forward from the end of the catheter according to the driving of the handle to provide light.
  • a needle electrode inserted along the inside of the catheter and inside the catheter to protrude forward from the end of the catheter according to the driving of the handle to provide light.
  • the needle electrode 200 includes a needle 210, an optical fiber 220 and a protective film 230.
  • the needle electrode 200 induces the activity of a beta cell responsible for the insulin secretion of the pancreas as a light stimulus, .
  • the needle 210 is inserted into a catheter (not shown) and protrudes forward according to an operation part provided on a handle (not shown).
  • the optical fiber 220 is attached to the needle 210 and provides light according to an external signal.
  • the provided light may be formed of a red wavelength (RED) of 600 nm or a near-infrared ray of 800 nm.
  • RED red wavelength
  • the protective film 230 serves to fix the optical fiber 220 to be attached to the needle 210 and the cutout portion 231 is formed in the protective film 230 so that the light projected to the optical fiber 220 is exposed to the outside. Therefore, light can be projected toward a lesion or the like of the pancreas through the incision 231.
  • the incision part 231 is formed with a front incision part 231a and a rear incision part 231b, and the front incision part 231a and the rear incision part 231b respectively irradiate the front part and the back part of the pancreas, It is possible to uniformly irradiate beta cells distributed over the entire surface area.
  • the front incision section 231a and the rear incision section 231b may be irradiated with light having different intensities.
  • the method of irradiating light is CW (continuous wave) and PW (pulsed wave) type, and it is preferable to use PW having excellent efficiency and effect, but the method of irradiating light is not limited thereto.
  • IRE ablation was performed after induction of general anesthesia in a surgical approach.
  • the pancreas was exposed in the abdomen and mobilized to perform the IRE.
  • IRE resection was performed by manual endoprosthesis using an endoscopic needle electrode.
  • the EUS guided endoscopic approach the linear EUS endoscope advances stomach.
  • the endoscope needle-electrode was inserted through the working channel of the scope.
  • the needle electrode was pierced and passed through the pancreas toward the needle or tail.
  • the delivered energy is 10 consecutive pulse waveforms with 5 pulses, pulse duration of 100 ⁇ s, amplitude of 2000 V, repetition frequency of 1 Hz, and a pause of 2 seconds between 5 pulse sequences.
  • the pigs were sacrificed 24 hours after the procedure and the pancreas was excised for histopathological evaluation. After formalin fixation, the thalamus of each pancreas was sampled at a thickness of about 2-3 mm from the thickness of the puncture site. Paraffin-embedded sections were cut and stained with hematoxylin and eosin (H & E).
  • the terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate digoxigenin nick endlabeling assay was also performed.
  • the terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate digoxigenin nick endlabeling assay was performed.
  • a digitized slide was obtained from the scanner and analyzed using the viewer software.
  • a needle-like electrode device for irreversible electric drilling was used as described above.
  • pancreas No significant findings of the pancreas were found except for small hematoma at the thoracic site (Fig. 5A).
  • Pathologic examination after sagittal incision showed well-differentiated pancreatic lesions (Fig. 5b).
  • the ablation site was round and measured 10-15 mm in size.
  • a small round hematoma near the ablation site was found in one pig.
  • Pathologic examination showed good necrosis of pancreatic parenchyma.
  • the pancreatic tissue stained with H & E showed round-shaped diffusion cell death at the center of the puncture site (FIG. 6A).
  • a necrotic, inflammatory change was noted if there was a residual pancreatic site at the ablation site (Fig. 6b).
  • Pancreatic tissue away from the puncture site was less damaged and normal acinar cells were preserved (Figure 6b).
  • blood vessels such as extracellular matrix, ducts and small arteries and arterioles are preserved. Within the restricted area, their original structure was preserved.
  • Positive results of the TUNEL assay (TUNEL assay) in the resected area indicate involvement of apoptosis (Figure 7).
  • TUNEL assay TUNEL assay
  • FIG. 7 In the round resected area, cell thickening (pyknosis) and pancreatic parenchymal karyorrhexis were observed. There were no significant differences in resection results between the surgical approach and the EUS - guided endoscopic approach.
  • the present invention has revealed that EUS induced IRE elimination of the pancreas is feasible and effective. Under real-time monitoring of EUS, the entire procedure could be performed and the pancreatic lesion could be accurately targeted. Experimental procedures were performed in only 6 animals, but no serious complications such as perforation, burns and procedural bleeding occurred. On the other hand, conventional THA requires open abdominal surgery under general anesthesia, and EUS induced IRE can be performed using only EUS without surgery.
  • EUS induced IRE was effective in eliminating pancreatic lesions and inducing necrosis of pancreatic parenchyma.
  • the electrodes were arranged linearly on the needle, but the resection was formed in a round shape.
  • the ablation site showed positive results of TUNEL analysis and cell death.
  • the original structure of the extracellular matrix, pancreatic duct, and blood vessels was preserved within the resected region.

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Abstract

La présente invention concerne une électrode de type aiguille pour l'électroporation irréversible à travers un endoscope comprenant : un corps creux; une poignée qui est disposée sur une extrémité du corps; un cathéter qui est formé à partir d'un matériau souple et qui est relié à l'autre extrémité du corps afin d'être inséré selon une procédure chirurgicale minimalement invasive reliée le long d'un sens; et une électrode aiguille qui se déplace le long de l'intérieur du cathéter et qui fait saillie vers l'avant depuis l'extrémité du cathéter selon l'entraînement de la poignée. L'électrode aiguille comprend : une aiguille; une électrode d'anode et une électrode de cathode espacées l'une de l'autre sous un intervalle prédéterminé sur l'aiguille; au moins une pièce d'isolation disposée le long de l'aiguille afin d'avoisiner l'électrode d'anode et l'électrode de cathode, séparant électriquement ainsi l'électrode d'anode et l'électrode de cathode; et une ligne d'anode et une ligne de cathode reliées à l'électrode d'anode et l'électrode de cathode, respectivement, et s'étendant, le long du cathéter et du corps, vers l'arrière.
PCT/KR2018/010448 2017-09-06 2018-09-06 Dispositif d'électrode de type aiguille pour l'électroporation irréversible à travers un endoscope WO2019050310A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20170113788 2017-09-06
KR10-2017-0113788 2017-09-06
KR10-2018-0106541 2018-09-06
KR1020180106541A KR102180645B1 (ko) 2017-09-06 2018-09-06 내시경을 통한 비가역적 전기천공술을 위한 바늘형 전극 장치

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040215237A1 (en) * 2003-04-25 2004-10-28 Medtronic, Inc. Neurostimulation delivery during transurethral prostate treatment
US20080255570A1 (en) * 2007-04-03 2008-10-16 Csaba Truckai Bone treatment systems and methods
US20100324363A1 (en) * 2008-03-05 2010-12-23 Board Of Regents, The University Of Texas System Disposable sheath designs for the stimulating endoscope and needle endoscopes having distal electrodes for nerve block under direct vision and methods for making and using same
KR101461525B1 (ko) * 2013-11-25 2014-11-26 한국과학기술연구원 광도파 효율이 개선된 광도파 부재를 구비한 신경 탐침 구조체 및 그 제조방법
KR101549786B1 (ko) * 2014-05-28 2015-09-03 사회복지법인 삼성생명공익재단 인체 삽입 전극 위치 감지 장치 및 방법

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040215237A1 (en) * 2003-04-25 2004-10-28 Medtronic, Inc. Neurostimulation delivery during transurethral prostate treatment
US20080255570A1 (en) * 2007-04-03 2008-10-16 Csaba Truckai Bone treatment systems and methods
US20100324363A1 (en) * 2008-03-05 2010-12-23 Board Of Regents, The University Of Texas System Disposable sheath designs for the stimulating endoscope and needle endoscopes having distal electrodes for nerve block under direct vision and methods for making and using same
KR101461525B1 (ko) * 2013-11-25 2014-11-26 한국과학기술연구원 광도파 효율이 개선된 광도파 부재를 구비한 신경 탐침 구조체 및 그 제조방법
KR101549786B1 (ko) * 2014-05-28 2015-09-03 사회복지법인 삼성생명공익재단 인체 삽입 전극 위치 감지 장치 및 방법

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