WO2019186786A1 - Treatment method - Google Patents

Abstract

This treatment method is for enhancing peristaltic movement of an intestinal tract and is minimally invasive. Surrounding nerves (Sa) for innervating the intestinal tract are present outside of a superior mesenteric artery (Va), a celiac artery (Vb), and an inferior mesenteric artery (Vc). A medical device (100) having an energy transmission member (120) is inserted into a vein (V) of a patient, energy is outputted from the energy transmission member (120) to the surrounding nerves (Sa), the surrounding nerves (Sa) are impaired, and autonomic neurotransmission by the surrounding nerves (Sa) to a digestive tract is completely or partially blocked. Accordingly, the sympathetic nervous system is attenuated relative to the parasympathetic nervous system. In addition, neurotransmission from the center is blocked, and the intestinal tract nervous system becomes dominant. As a result, since the peristaltic movement of the intestinal tract is enhanced, the alleviation of constipation, frequent defecation, unpleasant feelings of the perineum, abdominal pains, and sense of abdomen distension caused by abnormality of the peristaltic movement of the intestinal tract, is promoted.

Description

Treatment method

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.

Many patients with chronic constipation have not visited a medical institution, but if they do, they are treated with drugs to normalize the number of bowel movements and improve various abdominal symptoms due to constipation. Drugs with a mechanism that promotes intestinal peristalsis and drugs with a mechanism that promotes secretion from the intestinal tract or suppresses reabsorption and softens and swells stools are used as therapeutic agents. (For example, see Patent Document 1).

International Publication No. 2013-168671

However, it is widely known that patients who receive the above-mentioned medication treatment at medical institutions are not satisfied with the current treatment for the majority, and treatment with drugs in constipation treatment is an adequate solution. Not.

In addition, 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. On the other hand, 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. Among 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 Although referred to as “constipation”, 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.

As a result of intensive studies, 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.

According to the above treatment method, the peristaltic movement of the patient's intestinal tract can be enhanced.

It is a flowchart which shows roughly the procedure of the treatment method which concerns on embodiment. It is a figure which shows typically the blood vessel to which the treatment method which concerns on embodiment is applied. It is sectional drawing (longitudinal sectional view) which shows typically the mode in the blood vessel at the time of implementing the treatment method which concerns on embodiment. It is sectional drawing (transverse sectional view) which shows typically the mode in the blood vessel at the time of implementing the treatment method which concerns on embodiment.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the meaning of the technical scope and terms described in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

FIG. 1 schematically shows a procedure of a treatment method (hereinafter referred to as “treatment method”) according to the embodiment in a flowchart. As shown in FIG. 1, 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). .

Referring to FIG. 2, the blood vessel V that performs the treatment method will be described. In FIG. 2, the symbol VR indicates the right renal artery, and the symbol VL indicates the left renal artery. Reference sign Va indicates the superior mesenteric artery, reference sign Vb indicates the celiac artery, and 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). Although not particularly limited, for example, at least one of the superior mesenteric artery Va, the celiac artery Vb, and the inferior mesenteric artery Vc can be suitably selected.

Also, 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. For example, in the blood vessel V, 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). In addition, 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. . That is, 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 There are no particular restrictions on the specific contents, devices and instruments used for the treatment.

Next, with reference to FIG. 3 and FIG. 4, the medical device 100 used for the treatment method and treatment method which concern on this embodiment is demonstrated. Hereinafter, an example in which treatment is performed on the superior mesenteric artery Va as the blood vessel V to be treated will be described. Note that 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, and 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.

In the treatment according to the present embodiment, 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. By performing treatment to reduce the activity, peristaltic movement of the intestinal tract is increased. By performing such treatment, 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).

As described above, it is preferable to select at least one of the superior mesenteric artery Va, the celiac artery Vb, and the inferior mesenteric artery Vc as the blood vessel V to be treated. Then, the surgeon applies energy to one surrounding nerve Sa or a plurality of surrounding nerves Sa as a treatment. Thus, 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. When 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. In addition, by blocking nerve transmission from the center, intestinal motility is controlled autonomously in the periphery, but the enteric nervous system becomes dominant, and peristaltic movement of the intestinal tract is activated. In addition, activation of the 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. In particular, according to the treatment method according to the present embodiment, 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.

As the medical device 100, 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). Can be used. 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. In addition, about the specific structure of the medical device 100, it is possible to employ | adopt the structure of a well-known catheter device (for example, therapeutic catheter devices, such as an ablation device) suitably.

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). As the 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. In addition, as a transmission form of the operation command to the energy transmission member 120, for example, a method using a wire via an electric communication line, a method using a radio not via an electric communication line, or an operation via an operation unit incorporated in a control device. It is possible to cite the transmission based on the input from the person etc., the transmission performed based on the input from the external communication means prepared as a device different from the control device, etc. The specific form is not particularly limited. In addition, 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. In order to be able to provide the above-described performance, 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.

When inserting the medical device 100 into the blood vessel V, the surgeon can use, for example, a guide wire 200 and a guide catheter 300 as shown in FIG. As the guide wire 200 and the guide catheter 300, those known in the medical field can be used. In addition, 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. To the position (treatment site).

As shown in FIG. 3, 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.

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). In addition, the surgeon can also perform a treatment that arbitrarily combines the above-described energy application forms.

When performing the treatment, 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.

In addition, when performing the treatment, 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.

Further, the medical device 100 may include one or more expandable structures near the distal end portion of the medical device 100. When the medical device 100 is configured in this way, 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). For example, 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. When the expandable structure is configured integrally with the catheter body 110, for example, a part of the catheter body 110 is configured to be expandable. In this case, for example, the vicinity of the distal end portion of the catheter body 110 can be formed of a material having self-expandability and the like. When 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.

Further, 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). By arranging the medical device 100 in this manner, 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.

Further, the medical device 100 may include one or more sensors that enable temperature measurement near the distal end of the medical device 100. When the medical device 100 is configured as described above, 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. As a result, the formation of a stenosis or the like in the blood vessel V can be prevented. In addition, there is no restriction | limiting in particular about the kind of said sensor, the position to arrange | position, a number, etc.

Although the treatment method according to the present invention has been described above through the embodiments, the present invention is not limited to the contents described in the specification, and can be appropriately changed based on the description of the scope of claims. is there.

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. For example, 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.

Further, 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. Such 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.

Claims (20)

A treatment method that enhances 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 treatment promotes relief of at least one of the symptoms of abdominal fullness, abdominal pain, perineal discomfort, and frequent stools caused by abnormal constipation of the patient and / or peristaltic movement of the intestinal tract The treatment method according to claim 1. The treatment method according to claim 1, wherein the treatment promotes alleviation of symptoms of colon transit time delayed constipation. The blood vessel is at least one of superior mesenteric artery, celiac artery, inferior mesenteric artery,
The treatment includes damaging the surrounding nerve by applying energy to one of the surrounding nerves or a plurality of the surrounding nerves, and completely or partially blocking autonomic nerve transmission to the digestive tract by the surrounding nerves. The treatment method according to claim 1, wherein peristaltic movement of the intestinal tract is enhanced. The treatment method according to claim 4, wherein the treatment is performed by operating the medical device in a state where a medical device including an energy transmission member capable of applying the energy is disposed in the blood vessel. The treatment includes simple high frequency, bipolar high frequency, high intensity focused ultrasound, ultrasound, microwave, light, heat, cold radiation, engineering therapy, magnetic, electrical, electromagnetic, cryotherapy, plasma, mechanical energy The treatment method according to claim 5, wherein at least one of a group consisting of chemical energy, kinetic energy, latent energy, nuclear energy, elastic energy, and hydrodynamic energy is applied as the energy. . The treatment method according to claim 5, wherein the medical device is a catheter device including a long catheter body and the energy transmission member disposed at a distal end portion of the catheter body. The catheter body is movable following the curved or bent portion of the blood vessel of the patient to deliver the energy transfer member to the superior mesenteric movement, celiac artery, or inferior mesenteric artery The treatment method according to claim 7. The catheter device includes one or more expandable structures in the vicinity of a distal end portion thereof, and the expandable structure is expanded in the blood vessel and temporarily fixed to a blood vessel wall, whereby the catheter device is attached to the blood vessel. The treatment method according to claim 7, wherein the treatment method can be held at a predetermined position in a direction parallel to the lumen. The said catheter device is equipped with one or more sensors which enable temperature measurement near the front-end | tip part, and can control the output of the said energy based on the measurement result of the said sensor. Treatment method. 5. The treatment according to claim 4, wherein the treatment applies the energy in at least one of a circumferential direction of the blood vessel, a part of the circumferential direction of the blood vessel, a half of the circumferential direction of the blood vessel, a linear shape, and a radial shape. Treatment method. The treatment method according to claim 4, wherein the treatment applies energy of 100 ° C. or less to the blood vessel. The treatment is performed by controlling a range in which the energy is applied within a range of 0 ° to 360 ° of the cross section of the blood vessel, and the control allows a range in which the surrounding nerve is damaged to be 0% of the entire surrounding nerve. The treatment method according to claim 4, wherein the effect of enhancing the peristaltic movement of the intestinal tract can be adjusted by controlling in a range of% to 100%. Autonomic nerve activity is reduced by applying energy to one or a plurality of surrounding nerves from an energy transmission member provided in a catheter device inserted into a blood vessel having surrounding nerves that innervate a patient's intestinal tract. The treatment method which enhances the peristaltic movement of the intestinal tract by performing the treatment. The treatment method according to claim 14, wherein the blood vessel is at least one of an upper mesenteric artery, a celiac artery, and an inferior mesenteric artery. The catheter device includes a long catheter body, and the energy transmission member disposed at a distal end portion of the catheter body,
The catheter body is movable following a curved or bent portion of the patient's blood vessel to deliver the energy transfer member to the superior mesenteric movement, celiac artery, or inferior mesenteric artery, The treatment method according to claim 14. The treatment is performed by controlling a range in which the energy is applied within a range of 0 ° to 360 ° of the cross section of the blood vessel, and the control allows a range in which the surrounding nerve is damaged to be 0% of the entire surrounding nerve. The treatment method according to claim 14, wherein the effect of enhancing the peristaltic movement of the intestinal tract can be adjusted by controlling in a range of% to 100%. In the blood vessels with surrounding nerves that innervate the intestinal tract of the patient, by reducing the autonomic nerve activity, the peristaltic movement of the intestinal tract is enhanced, and the symptoms of colon transit time delayed constipation are alleviated. Prompt, treatment method. The treatment method according to claim 18, wherein the treatment is performed by operating the medical device in a state where a medical device including an energy transmission member capable of applying energy is disposed in the blood vessel. The treatment method according to claim 19, wherein the medical device is a catheter device including a long catheter body and the energy transmission member disposed at a distal end portion of the catheter body.

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