WO2019186786A1 - Procédé de traitement - Google Patents

Procédé de traitement Download PDF

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Publication number
WO2019186786A1
WO2019186786A1 PCT/JP2018/012839 JP2018012839W WO2019186786A1 WO 2019186786 A1 WO2019186786 A1 WO 2019186786A1 JP 2018012839 W JP2018012839 W JP 2018012839W WO 2019186786 A1 WO2019186786 A1 WO 2019186786A1
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WO
WIPO (PCT)
Prior art keywords
energy
blood vessel
treatment
treatment method
intestinal tract
Prior art date
Application number
PCT/JP2018/012839
Other languages
English (en)
Japanese (ja)
Inventor
知幸 田島
一幸 齊藤
翔平 松原
嘉気 渡部
Original Assignee
株式会社Alivas
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 株式会社Alivas filed Critical 株式会社Alivas
Priority to PCT/JP2018/012839 priority Critical patent/WO2019186786A1/fr
Priority to PCT/JP2019/013892 priority patent/WO2019189702A1/fr
Priority to JP2020511056A priority patent/JPWO2019189702A1/ja
Publication of WO2019186786A1 publication Critical patent/WO2019186786A1/fr
Priority to US17/032,897 priority patent/US20210007799A1/en

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    • 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

Definitions

  • the present invention relates to a treatment method for enhancing peristaltic movement of the intestinal tract.
  • Constipation is a common illness that is frequently observed worldwide and is said to affect 25-30% of the population.
  • Chronic constipation is defined as having bowel movements less than 3 times a week and having difficulty in defecation. It is known that the decrease in the number of defecations may cause symptoms such as abdominal fullness and abdominal pain, difficulty of defecation, discomfort during defecation, frequent frequent stools, and so on, which significantly impairs the social activity and mental health of patients.
  • chronic constipation includes primary (idiopathic) and secondary. Secondary is caused by organic diseases such as colorectal cancer, caused by drugs such as opioids used for pain relief, and associated with systemic diseases such as neurological diseases and collagen diseases.
  • primary (idiopathic) constipation is divided into organic constipation and functional constipation depending on the presence or absence of organic abnormalities (such as dilation) in the colon.
  • functional constipation with no organic abnormalities in the colon, the bowel movement of the large intestine is reduced, so that the stool transit time is delayed and the constipation is seen as ⁇ colon transit time delay type
  • the effectiveness of oral treatment is particularly poor for these patients. Total colectomy or partial excision may be recommended for patients with severe constipation who are refractory to oral treatment, but it is not widely accepted because of its invasiveness.
  • the inventors of the present invention have found an effective and minimally invasive treatment method for various symptoms and diseases caused by a decrease or insufficiency of peristaltic movement of the intestinal tract.
  • the treatment method according to the present invention includes enhancing peristaltic movement of the intestinal tract by performing a treatment that reduces the activity of the autonomic nerve in a blood vessel having a peripheral nerve that performs innervation of the patient's intestinal tract.
  • the peristaltic movement of the patient's intestinal tract can be enhanced.
  • FIG. 1 schematically shows a procedure of a treatment method (hereinafter referred to as “treatment method”) according to the embodiment in a flowchart.
  • the treatment method generally includes delivering a predetermined medical device into a blood vessel for performing the treatment (S11) and performing the treatment within the blood vessel (S12). .
  • the blood vessel V that performs the treatment method will be described.
  • the symbol VR indicates the right renal artery
  • the symbol VL indicates the left renal artery.
  • Reference sign Va indicates the superior mesenteric artery
  • reference sign Vb indicates the celiac artery
  • reference sign Vc indicates the inferior mesenteric artery.
  • the blood vessel V to which the treatment method is applied may be able to enhance the peristaltic movement of the intestinal tract of the patient (subject) by being subjected to the predetermined treatment according to the embodiment (for example, application of energy described later).
  • the predetermined treatment for example, application of energy described later.
  • at least one of the superior mesenteric artery Va, the celiac artery Vb, and the inferior mesenteric artery Vc can be suitably selected.
  • the treatment site (range, position, etc.) where treatment is performed in the blood vessel V is not particularly limited as long as the peristaltic movement of the intestinal tract can be enhanced.
  • treatment may be performed on an arbitrary range (part) in the traveling direction (extending direction) of the blood vessel V, or in the circumferential direction of the blood vessel V (circumferential direction in the cross section). Treatment may be performed on the range (site).
  • the treatment may be performed a plurality of times for a plurality of treatment sites of the same blood vessel V, or may be performed a plurality of times for any treatment site of different blood vessels V. .
  • the treatment method according to the present embodiment is capable of enhancing the peristaltic movement of the patient's intestinal tract by performing at least one treatment, so that the type of blood vessel to be treated, the treatment site of the blood vessel, the treatment
  • the treatment There are no particular restrictions on the specific contents, devices and instruments used for the treatment.
  • the medical device 100 used for the treatment method and treatment method which concern on this embodiment is demonstrated.
  • an example in which treatment is performed on the superior mesenteric artery Va as the blood vessel V to be treated will be described.
  • the procedure described below is merely an example, and for example, a procedure known in the medical field can be appropriately adopted as a part of the procedure or a procedure not particularly described.
  • FIG. 3 is a cross-sectional view (longitudinal cross-sectional view) schematically showing a state in the blood vessel V when the treatment method is being performed
  • FIG. 4 is a view inside the blood vessel V when the treatment method is being performed.
  • It is sectional drawing (transverse sectional view) which shows a mode typically. 3 and 4, the traveling direction of the blood vessel V is indicated by an arrow X, the depth direction orthogonal to the traveling direction of the blood vessel V is indicated by an arrow Y, and each of the traveling direction of the blood vessel V and the depth direction of the blood vessel V is illustrated.
  • An orthogonal direction is indicated by an arrow Z.
  • an operator such as a doctor (hereinafter referred to as “operator”) has an autonomic nerve in a blood vessel V having a peripheral nerve (plexus) Sa that performs innervation of the intestinal tract of the patient.
  • a peripheral nerve plexus
  • peristaltic movement of the intestinal tract is increased.
  • the surgeon can perform at least one symptom of abdominal bloating, abdominal pain, perineal discomfort, and frequent stool due to abnormal constipation and / or peristaltic movement of the intestinal tract. Helps alleviate (at least one of a group of symptoms caused by an alleviation of patient constipation and / or abnormal intestinal peristalsis).
  • the surgeon applies energy to one surrounding nerve Sa or a plurality of surrounding nerves Sa as a treatment.
  • the surgeon increases the peristaltic movement of the intestinal tract by damaging the peripheral nerve Sa and completely or partially blocking the autonomic nerve transmission to the digestive tract by the peripheral nerve Sa.
  • the following points can be considered as reasons why the peristaltic movement of the intestinal tract is activated by performing a treatment for reducing the activity of the autonomic nerve in the blood vessel V having the surrounding nerve Sa.
  • the peripheral nerve Sa is damaged by the energy applied from within the blood vessel V, and the autonomic nerve transmission to the digestive tract by the peripheral nerve Sa is completely or partially blocked, the sympathetic nervous system is relative to the sympathetic nervous system and parasympathetic nervous system. It becomes attenuated and becomes parasympathetic dominant.
  • intestinal motility is controlled autonomously in the periphery, but the enteric nervous system becomes dominant, and peristaltic movement of the intestinal tract is activated.
  • intestinal peristaltic movement promotes and normalizes the colon transit time, so that abdominal fullness, abdominal pain, perineal discomfort, frequent stool due to abnormal constipation and / or intestinal peristaltic movement Alleviation of at least one of the symptoms is promoted.
  • intestinal peristalsis movement of the large intestine is reduced in functional constipation with no organic abnormality in the colon, and therefore, the stool passage time is delayed and constipation is observed. It is possible to favorably alleviate the symptoms of colon transit time delayed constipation.
  • the surgeon can perform treatment using a predetermined medical device 100 as shown in FIGS. 3 and 4, for example. Specifically, the surgeon can perform a treatment by operating the medical device 100 in a state where the medical device 100 including the energy transmission member 120 capable of applying energy is disposed in the blood vessel V. 3 and 4, energy applied by the medical device 100 is schematically indicated by a dotted arrow.
  • a catheter device including an elongated catheter body 110 and an energy transmission member 120 disposed at the distal end portion of the catheter body 110 (near the end portion on the insertion direction side in the blood vessel V).
  • the catheter main body 110 includes a lumen (not shown) extending in the major axis direction (extending direction) of the catheter main body 110 and a proximal end portion of the catheter main body 110 (in the vicinity of the end opposite to the insertion direction into the blood vessel V). And a hub (not shown).
  • the medical device 100 can insert a medical instrument such as a guide wire 200 or distribute a liquid such as a priming liquid through a lumen and a hub.
  • the energy transmission member 120 included in the medical device 100 is, for example, simple high frequency, bipolar high frequency, high-density focused ultrasound, ultrasonic, microwave, light, heat, cold radiation, engineering therapy, magnetic, electrical, electromagnetic , Cryotherapy, plasma, mechanical energy, chemical energy, kinetic energy, potential energy, nuclear energy, elastic energy, hydrodynamic energy from the inside of blood vessel V It can be configured to be granted.
  • the operation of the energy transmission member 120 can be controlled, for example, via a controller (control device) (not shown).
  • a controller for example, a known control device including a CPU and a storage unit can be used.
  • the storage unit includes a ROM that stores various programs and data, a RAM that temporarily stores programs and data as a work area, and a hard disk that can store various programs and data. A series of programs necessary for operation control of the medical device 100 can be stored in the storage unit.
  • the energy transmission member 120 is electrically connected to a power supply unit (not shown), and can control ON / OFF of the operation, the magnitude of energy applied to the blood vessel V, and the like via the power supply unit.
  • the treatment according to the present embodiment may be performed by a medical device such as a treatment robot that replaces the work performed by the operator. In this case, for the treatment, an operator or the like may control the treatment robot at a medical site such as an operating room, or may control the treatment robot at a remote place.
  • the catheter body 110 included in the medical device 100 follows a curved or bent portion of a patient's blood vessel in order to deliver the energy transmission member 120 to the superior mesenteric artery Va, the celiac artery Vb, or the inferior mesenteric artery Vc. Therefore, it is preferable that the mobile phone is configured to be movable.
  • the catheter body 110 employs, for example, various materials and structures used for known catheter devices having flexibility, torque transmission, kink resistance, and the like. be able to.
  • the surgeon can use, for example, a guide wire 200 and a guide catheter 300 as shown in FIG.
  • the guide wire 200 and the guide catheter 300 those known in the medical field can be used.
  • the surgeon wants the medical device 100 to be a blood vessel V (any blood vessel of the superior mesenteric artery Va, the celiac artery Vb, the inferior mesenteric artery Vc) via, for example, the femoral artery, the abdominal aorta, or the like.
  • a blood vessel V any blood vessel of the superior mesenteric artery Va, the celiac artery Vb, the inferior mesenteric artery Vc
  • the surgeon delivers the energy transmission member 120 to a desired position in the blood vessel V, and then operates the energy transmission member 120 so that the surrounding nerves existing outside the blood vessel V from inside the blood vessel V are operated.
  • Energy is given to Sa.
  • the surgeon when performing treatment, for example, the surgeon, for example, in the entire circumferential direction of the blood vessel V (a form in which there is no intermittence along the inner wall of the blood vessel V), a part of the circumferential direction of the blood vessel V (the circumferential direction of the inner wall of the blood vessel V) Only a part, for example, a form less than a half circumference), a half circumference of the blood vessel V (a half form in the circumferential direction of the inner wall of the blood vessel V), a linear shape (a form continuous in a certain length in the circumferential direction of the inner wall of the blood vessel V) , And energy (in a direction away from the center of the cross section of the blood vessel V outward in the radial direction of the blood vessel V).
  • the surgeon can also perform a treatment that arbitrarily combines the above-described energy application forms.
  • the surgeon can adjust the output of the energy transmission member 120 so that, for example, energy of 100 ° C. or less is applied to the blood vessel V.
  • the surgeon controls, for example, a range in which energy is applied within an arbitrary range of 0 ° to 360 ° (range in the direction indicated by arrow a1 in FIG. 4) of the cross section of the blood vessel V. Can do.
  • the surgeon can control the range in which the surrounding nerve Sa is damaged within a range of 0% to 100% of the entire surrounding nerve Sa, and can adjust the effect of enhancing the peristaltic movement of the intestinal tract.
  • the medical device 100 may include one or more expandable structures near the distal end portion of the medical device 100.
  • the surgeon expands the expandable structure in the blood vessel V and temporarily fixes the expandable structure to the blood vessel wall, so that the medical device 100 is parallel to the lumen of the blood vessel. It can be held at a predetermined position in the (blood vessel extending direction).
  • the expandable structure may be configured integrally with the catheter body 110 or may be configured as a separate body (separate device) from the catheter body 110.
  • a part of the catheter body 110 is configured to be expandable.
  • the vicinity of the distal end portion of the catheter body 110 can be formed of a material having self-expandability and the like.
  • the expandable structure is configured separately from the catheter body 110, for example, the expandable structure includes a shaft formed with a lumen through which the medical device 100 can be inserted and protruded toward the distal end, and expansion and contraction. And possible balloons.
  • the surgeon when the surgeon performs a treatment using the medical device 100, for example, a position close to a predetermined site in the circumferential direction of the blood vessel V from the center position C1 on the transverse section of the blood vessel V (eccentric from the center position C1).
  • the central position of the medical device 100 may be disposed at the position).
  • the surgeon can effectively apply energy to the peripheral nerve Sa from any position in the circumferential direction of the blood vessel V.
  • the medical device 100 can be appropriately provided with a positioning mechanism for arranging the medical device 100 as described above.
  • the positioning mechanism can be constituted by a part of the catheter main body or a balloon similarly to the expandable structure, for example.
  • the medical device 100 may include one or more sensors that enable temperature measurement near the distal end of the medical device 100.
  • the surgeon can control the output of energy based on the measurement result of the sensor.
  • the surgeon appropriately controls the output of energy based on the measurement result of the sensor, so that the effect of promoting peristaltic movement due to insufficient energy to be imparted is insufficient or excessive energy is imparted to the blood vessel V.
  • the formation of a stenosis or the like in the blood vessel V can be prevented.
  • the medical device used for the treatment method is not particularly limited in its specific structure and arrangement of members as long as energy can be applied in the blood vessel.
  • omission of each member (structure) of the medical device described with reference to the drawings, use of other additional members not specifically described, modification to a device other than the catheter device, and the like can be appropriately performed.
  • the treatment method is specific as long as it includes at least enhancing peristaltic movement of the intestinal tract by performing a treatment that reduces the activity of the autonomic nerve in a blood vessel having a peripheral nerve that performs innervation of the patient's intestinal tract.
  • a procedure is not particularly limited.
  • 100 medical device catheter device
  • 110 catheter body 120 energy transmission member
  • 200 guide wire 300 guide catheter
  • V blood vessels Va superior mesenteric artery (blood vessel), Vb celiac artery (blood vessel), Vc inferior mesenteric artery (blood vessel), Sa Peripheral nerve.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un procédé de traitement destiné à améliorer le mouvement péristaltique d'un tractus intestinal, minimalement invasif. Des nerfs environnants (Sa) pour innerver le tractus intestinal sont présents à l'extérieur d'une artère mésentérique supérieure (Va), d'une artère coeliaque (Vb) et d'une artère mésentérique inférieure (Vc). Un dispositif médical (100) ayant un élément de transmission d'énergie (120) est inséré dans une veine (V) d'un patient, de l'énergie est émise à partir de l'élément de transmission d'énergie (120) vers les nerfs environnants (Sa), les nerfs environnants (Sa) sont détériorés, et la neurotransmission autonome par les nerfs environnants (Sa) vers un tube digestif est complètement ou partiellement bloquée. Par conséquent, le système nerveux sympathique est atténué par rapport au système nerveux parasympathique. De plus, la neurotransmission du centre est bloquée, et le système nerveux du tractus intestinal devient dominant. Par conséquent, étant donné que le mouvement péristaltique du tractus intestinal est amélioré, le soulagement de la constipation, de la défécation fréquente, des sensations déplaisantes du périnée, des douleurs abdominales, et des sensations de distension de l'abdomen provoquées par une anomalie du mouvement péristaltique du tractus intestinal, est favorisé.
PCT/JP2018/012839 2018-03-28 2018-03-28 Procédé de traitement WO2019186786A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
PCT/JP2018/012839 WO2019186786A1 (fr) 2018-03-28 2018-03-28 Procédé de traitement
PCT/JP2019/013892 WO2019189702A1 (fr) 2018-03-28 2019-03-28 Procédé de traitement de dispositif médical
JP2020511056A JPWO2019189702A1 (ja) 2018-03-28 2019-03-28 処置方法および医療デバイス
US17/032,897 US20210007799A1 (en) 2018-03-28 2020-09-25 Treatment Method and Medical Device

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2018/012839 WO2019186786A1 (fr) 2018-03-28 2018-03-28 Procédé de traitement

Related Child Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2019/013892 Continuation WO2019189702A1 (fr) 2018-03-28 2019-03-28 Procédé de traitement de dispositif médical

Publications (1)

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WO2019186786A1 true WO2019186786A1 (fr) 2019-10-03

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PCT/JP2018/012839 WO2019186786A1 (fr) 2018-03-28 2018-03-28 Procédé de traitement

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013134541A2 (fr) * 2012-03-08 2013-09-12 Medtronic Ardian Luxembourg Sarl Neuromodulation gastro-intestinale et méthodes et systèmes associés
JP2014525786A (ja) * 2011-07-22 2014-10-02 コーニンクレッカ フィリップス エヌ ヴェ アブレーション装置
JP2015119831A (ja) * 2013-12-24 2015-07-02 テルモ株式会社 アブレーションカテーテル
WO2016039394A1 (fr) * 2014-09-12 2016-03-17 テルモ株式会社 Cathéter d'ablation

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014525786A (ja) * 2011-07-22 2014-10-02 コーニンクレッカ フィリップス エヌ ヴェ アブレーション装置
WO2013134541A2 (fr) * 2012-03-08 2013-09-12 Medtronic Ardian Luxembourg Sarl Neuromodulation gastro-intestinale et méthodes et systèmes associés
JP2015119831A (ja) * 2013-12-24 2015-07-02 テルモ株式会社 アブレーションカテーテル
WO2016039394A1 (fr) * 2014-09-12 2016-03-17 テルモ株式会社 Cathéter d'ablation

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