medical equipment

Abstract

[Problem] To provide a medical appliance and lumen treatment method capable of introducing intestinal bacteria up to a distal side such as the ascending colon without changing the position of the patient's body or inflating the large intestine as in the case of endoscopy of the large intestine. [Solution] A medical instrument 1 according to one aspect of the present invention has a hollow tubular member 100 which can be inserted into the lumen of a patient, and an elongated wire member 200 which can be inserted into an inner cavity of the tubular member, wherein the wire member is provided with: a handle section 210 which can be gripped by a user; a curved section 240 which is provided to the tip end section opposite the handle in the lengthwise direction, and in which a wire is curved at a tip end section when moving through the lumen; a first site 220 from the handle to the curved section; a second site 230 provided so as to return back from the curved section; and a supporting section 250 provided to the second site and capable of coming in contact with an inner wall of the lumen.

Description

[Technical Field]

[0001] The present invention relates to medical devices and methods for treating lumens. [Background technology]

[0002] A known treatment involves administering enteric bacteria contained in the feces of healthy individuals to sick patients. This type of treatment is called fecal microbiota transplantation (FMT). This type of treatment can be applied to patients with recurrent clostridial infections or refractory inflammatory bowel diseases (such as Crohn's disease and ulcerative colitis).

[0003] An example of a conventional technique related to FMT is described in Patent Document 1. In Patent Document 1, a fecal microbiota donation bank receives fecal samples from pre-screened donors, mixes the fecal sample with a liquid to form a mixture, homogenizes the mixture, or the like to produce a filtrate containing the microbiota of the fecal sample, and formulates the filtrate into a pharmaceutical composition. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Publication No. 2019-194202 Summary of the Invention [Problem to be solved by the invention]

[0005] When transplanting intestinal bacteria into a patient's intestine, the procedure is conventionally performed while observing the patient's intestinal interior using a colonoscope, etc. During this procedure, the patient's intestine must be inflated by injecting a fluid such as air so that medical instruments such as a colonoscope can be inserted into the intestine, but the injection of the fluid can cause discomfort and stress to the patient.

[0006] In addition, the surgeon must administer the intestinal bacteria to the complex and long intestinal structures, such as the descending colon, transverse colon, and ascending colon. This requires the patient to be repositioned depending on the medical equipment used, which places a greater burden on the patient.

[0007] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a medical device and a method for treating a lumen that can administer intestinal bacteria to the distal side of the large intestine without distending the patient's large intestine as occurs when an endoscope or the like is introduced, and without changing the patient's position. [Means for solving the problem]

[0008] A medical device according to one aspect of the present invention that achieves the above object includes a hollow tubular member that can be inserted into a patient's lumen, and a long wire member that can be inserted into the lumen of the tubular member. The wire member includes a proximal portion, a bending portion, a first portion, a second portion, and a support portion. The proximal portion is configured to be grippable by a user. The bending portion is provided at the distal end opposite the proximal portion in the longitudinal direction, and is configured to bend so that the wire can be deformed at the distal end as it advances through the lumen. The first portion is provided from the proximal portion to the bending portion. The second portion is provided so as to fold back from the bending portion. The support portion is provided at the second portion and is configured to be able to contact the inner wall of the lumen.

[0009] Furthermore, a method for treating a lumen according to one aspect of the present invention uses the above-described medical device and includes a first step, a second step, a third step, and a fourth step. In the first step, a wire member is inserted into a lumen of a patient. In the second step, the wire member is advanced distally into the lumen, with the support portion in contact with the inner wall of the lumen, using the support portion as a base point to change the position of the bent portion in the longitudinal direction of the wire member. In the third step, after the second step, a tubular member is inserted into the lumen along the wire member so that the wire member is positioned in the lumen of the tubular member. In the fourth step, after the third step, the wire member is pulled. [Effects of the Invention]

[0010] According to the above-described medical device and method for treating a lumen, it is possible to administer intestinal bacteria to the distal part of the large intestine without distending the patient's large intestine, as is the case when an endoscope or the like is introduced, and without changing the patient's position. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is a view showing the inside of a human body (large intestine) into which a medical device according to a first embodiment of the present invention is introduced. [Figure 2] 1 is a view showing a tubular member and a wire member that constitute a medical device according to a first embodiment of the present invention. [Figure 3] 3 is a view showing the vicinity of the tip of the wire member in FIG. 2. FIG. [Figure 4] 3 is a flowchart showing a method for treating a lumen using the medical device shown in FIG. 2. [Figure 5] FIG. 3 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. 2. [Figure 6] FIG. 3 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. 2. [Figure 7] FIG. 3 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. 2. [Figure 8] FIG. 3 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. 2. [Figure 9] 10A and 10B are diagrams showing modified examples of the support portion of the wire member. [Figure 10] 10A and 10B are diagrams illustrating attachment of protrusions provided on a support portion. [Figure 11] 10A and 10B are diagrams showing modified examples of protrusions provided on the support portion of the wire member. [Figure 12] 10A and 10B are diagrams showing modified examples of the support portion of the wire member. [Figure 13] FIG. 6 is a view showing a tubular member and a wire member that constitute a medical device according to a second embodiment of the present invention. [Figure 14] 14 is a cross-sectional view of the medical device shown in FIG. 13, taken along a line intersecting the longitudinal direction. [Figure 15]14 is a flowchart showing a method for treating a lumen using the medical device shown in FIG. 13. [Figure 16] FIG. 14 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. [Figure 17] FIG. 14 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. [Figure 18] FIG. 14 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. [Figure 19] FIG. 14 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. [Figure 20] FIG. 14 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. [Figure 21] FIG. 14 is a diagram showing a procedure for administering intestinal bacteria to the large intestine using the medical device shown in FIG. DETAILED DESCRIPTION OF THE INVENTION

[0012] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely examples for embodying the technical concept of the present invention and are not intended to limit the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, as well as within the scope of the claims and their equivalents.

[0013] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

[0014] In the following description, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, these are used for convenience and do not stipulate any particular order.

[0015] The medical device 1 will be described below with reference to Figures 1 to 3. Figure 1 is a schematic view showing the inside of a human body into which the medical device 1 according to this embodiment is introduced. Figure 2 is a view showing a tubular member 100 and a wire member 200 that constitute the medical device 1 according to the first embodiment of the present invention. Figure 3 is a view showing the vicinity of the distal end of the wire member 200.

[0016] The medical device 1 according to this embodiment can be used as an intestinal treatment device for administering intestinal bacteria from healthy individuals to the large intestine of a patient. The large intestine into which the medical device 1 is introduced is complex and long, including the rectum C1, descending colon C2, transverse colon C3, and ascending colon C4, with the rectosigmoid portion of the rectum C1 and the left colonic flexure (splenic flexure) Cm of the descending colon C2 and transverse colon C3 having particularly large curvatures (see FIG. 1). The medical device 1 introduced into the intestine as shown in FIG. 1 includes, generally with reference to FIG. 2, a tubular member 100 and a wire member 200. This will be described in more detail below.

[0017] (Tubular member) The tubular member 100 is hollow and can be inserted into the lumen of the large intestine of a patient. As shown in Figure 2, the tubular member 100 includes a long section 110, a proximal section 120, a first introduction section 130, and a second introduction section 140.

[0018] The long section 110 has a circular cross section perpendicular to its longitudinal axis. The long section 110 is configured to have a lumen L (corresponding to an inner cavity) through which the wire member 200 (described later) can be introduced and through which the intestinal bacteria can flow. In addition, a plurality of micropores can be provided on the side surface of the distal end of the long section 110 so that the intestinal bacteria can be administered into the intestines.

[0019] The material of the long portion 110 is not particularly limited, but examples that can be used include polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer; thermoplastic resins such as soft polyvinyl chloride; various elastomers such as silicone rubber, polyurethane elastomer, polyamide elastomer, polyester elastomer, and polystyrene elastomer; and crystalline plastics such as polyamide, crystalline polyethylene, and crystalline polypropylene.

[0020] The proximal portion 120 is configured to be grippable by the fingers of the surgeon. The proximal portion 120 is configured to be provided with a first introduction portion 130 and a second introduction portion 140. In this embodiment, the proximal portion 120 is configured to be approximately cylindrical. The proximal portion 120 is configured to be hollow so that the wire member 200 and the intestinal bacteria can flow through the long portion 110.

[0021] The first introduction part 130 is configured to be able to introduce intestinal bacteria into the lumen L of the long part 110. The first introduction part 130 has a hollow cylindrical shape that extends so as to intersect obliquely with the axis of the cylindrical shape of the proximal part 120. The lumen of the first introduction part 130 is configured to communicate with the lumen L of the long part 110. A filter for filtering intestinal bacteria such as stool samples may be provided at the base end of the first introduction part 130.

[0022] The second introduction section 140 is provided at the base end of the proximal section 120. The second introduction section 140 is provided so as to extend axially from the base end of the cylindrical shape of the proximal section 120. The second introduction section 140 is configured to have a hole for introducing the wire member 200. The hole of the second introduction section 140 is configured to communicate with the lumen L of the long section 110.

[0023] That is, the tubular member 100 is configured as an over-the-wire type in which the wire member 200 is introduced from the base end. The second introduction section 140 is configured to introduce the wire member 200 from the base end side at the base end of the proximal section 120 and to prevent the intestinal bacteria introduced from the first introduction section 130 from leaking out from the base end side. That is, the second introduction section 140 can be configured, for example, so that the hole through which the wire member 200 is introduced when the wire member 200 is removed is closed (sealed) with a sealing member or the like.

[0024] (wire material) The wire member 200 is configured in an elongated shape and can be inserted into the lumen L of the tubular member 100. As shown in Fig. 2, the wire member 200 includes a proximal portion 210, a first portion 220, a second portion 230, a bending portion 240, and a support portion 250. The material constituting the wire member 200 is not particularly limited, but examples include stainless steel, a superelastic alloy such as a Ni-Ti alloy, a shape memory alloy, etc.

[0025] The proximal portion 210 is a portion that is grasped by the fingers of the surgeon during the procedure and is located outside the body. The first portion 220 corresponds to the portion from the proximal portion 210 to the bending portion 240.

[0026] The second section 230 is a section different from the first section 220 and corresponds to the folded section from the bending section 240 to the end opposite the bending section 240. In this embodiment, the cross-sectional shape of the second section 230 perpendicular to the longitudinal axis is configured as a flattened rectangle. However, the shape of the second section is not limited to a rectangle and may be an ellipse, for example. Configuring the cross-sectional shape of the wire member 200 as described above makes it easier to advance the wire member 200 distally (toward the back) of the intestine. Furthermore, the section having a rectangular or elliptical cross section is not limited to the second section 230; the distal end side of the first section 220 forming the bending section 240 may also be configured in a similar manner. Furthermore, in this embodiment, the wire member 200 has a uniform hardness in the longitudinal direction of the wire. However, this is not limited thereto, and the first section 220 and the second section 230 may have different hardnesses, or the second section 230 and the support section 250 may be made of a harder material than the bending section 240. Alternatively, the tip side of first part 220 may be configured to be more flexible than the base side, and the base side of first part 220 may be configured to be more rigid than the tip side.

[0027] The bending portion 240 is provided at the tip of the wire member 200 opposite the proximal portion 210 in the longitudinal direction, and is configured as a portion where the tip of the wire is not substantially straight but is bent so as to be deformable when the wire member advances through a lumen. In other words, the bending portion 240 does not necessarily have to be bent at the time of distribution of the medical device 1 (initial state of the product at room temperature), and may be configured in a straight shape, as long as the wire member includes a shape memory alloy or the like and is bent when the wire member advances through a lumen. The wire member 200 has stiffness and can bend. While the first portion 220 is configured to be substantially straight when no external force is applied, the bending portion 240 is configured to be curved in a U-shape, for example. The position of the bending portion 240 in the longitudinal direction of the wire member 200 is configured to be displaceable with the support portion 250 as a base point.

[0028] The support section 250 is provided in the second section 230. The support section 250 is configured to be able to come into contact with the inner wall of the lumen so that when the wire member 200 is introduced into a biological lumen, the tip side of the wire member 200 can be advanced distally while changing the position of the bending section 240. The support section 250 is configured so that the tip of the wire is folded back by the bending section 240 so that it faces the base end side in the longitudinal direction.

[0029] As shown in FIG. 2, in this embodiment, the support portion 250 is provided with a curved portion 251 at the tip of the second portion 230 so as to be curved back and away from the first portion 220 in a direction intersecting the longitudinal direction.

[0030] (Treatment method) Next, a method for treating a lumen using the medical device 1 according to this embodiment will be described. Fig. 4 is a flowchart illustrating the method for treating a lumen using the medical device 1, and Figs. 5 to 8 are diagrams showing how the medical device 1 is introduced into the intestine.

[0031] First, the surgeon inserts the distal end of the wire member 200 into the patient's anus (first procedure, S1). The position of the wire member 200 can be confirmed by an echo image or the like.

[0032] When inserting the tubular member 100 into the patient's intestine, the surgeon brings the support portion 250 of the wire member 200 into contact with the inner wall of the intestine. Then, with the support portion 250 in contact with the inner wall of the intestine, the surgeon advances the tip side of the wire member 200 distally so as to change the position of the bent portion 240 with the support portion 250 as a base point, as shown in Figures 5 and 6 (second procedure, S2). Providing the bent portion 240 at the tip side of the wire member 200 makes it possible to avoid damaging the inner wall of the intestine.

[0033] After the wire member 200 has been advanced to the distal side of the large intestine so that the position of the bending portion 240 changes, the surgeon advances the tubular member 100 along the wire member 200 to the distal side of the large intestine so that the wire member 200 is positioned in the lumen of the tubular member 100 as shown in Figure 7 (third step, S3).

[0034] After the tubular member 100 has been advanced distally along the wire member 200, the surgeon pulls the wire member 200 toward the operator's hand while maintaining the longitudinal position of the tubular member 100 as shown in Fig. 8 (fourth step, S4). This moves the position of the support part 250 in the intestine distally.

[0035] The surgeon repeats steps S2 to S5 until the tip of the long portion 110 of the tubular member 100 reaches the desired position in the intestine where the intestinal bacteria is to be administered (S5; NO).

[0036] Once it is confirmed that the distal end of the tubular member 100 has reached the target site in the intestine (S5; YES), the surgeon removes the wire member 200 from the body lumen. Then, the surgeon introduces intestinal bacteria from the first introduction section 130 while sealing the second introduction section 140 with a sealing member or the like, and administers (transplants) the intestinal bacteria from the distal end of the tubular member 100 (S6). The intestinal bacteria may be transplanted each time the tubular member 100 is pulled a predetermined distance from the distal side back toward the proximal side (multiple administrations). Once administration of the intestinal bacteria is complete, the surgeon removes the tubular member 100 from the intestine (S7).

[0037] As described above, the medical device 1 according to this embodiment has a hollow tubular member 100 that can be inserted into a patient's lumen, and a long wire member 200 that can be inserted into the lumen of the tubular member 100. The wire member 200 includes a proximal portion 210, a bending portion 240, a first portion 220, a second portion 230, and a support portion 250. The proximal portion 210 is configured to be grippable by the user.

[0038] The bending section 240 is provided at the distal end opposite the proximal section 210 in the longitudinal direction, and is configured so that the wire can bend deformably at the distal end as it advances through the lumen. The first section 220 corresponds to the section from the proximal section 210 to the bending section 240. The second section 230 is provided so as to bend back from the bending section 240. The support section 250 is provided at the second section 230, and is configured so as to be able to contact the inner wall of the lumen.

[0039] In this way, since the wire member 200 is used to insert the tubular member 100, the tubular member 100 can be advanced to the ascending colon and the intestinal bacteria can be administered without expanding the inside of the intestine. Furthermore, the tubular member 100 is advanced into the intestine by using the flexible wire member 200. Therefore, the tubular member 100 can be advanced to the target site, such as the ascending colon, without changing the patient's position.

[0040] Furthermore, the support portion 250 is configured to bend back at the tip of the second portion 230 in a direction intersecting the longitudinal direction so as to move away from the first portion 220. With this configuration, the support portion 250 is brought into contact with the inner wall of the intestine, and the wire member 200 is advanced distally so as to change the position of the bending portion 240 using the support portion 250 as a base point, thereby allowing the tubular member 100 to advance to the distal side of the intestine.

[0041] Furthermore, the second section 230 has an elliptical or flattened cross section perpendicular to the longitudinal axis. This configuration makes it easier to form the bent section 240 and prevents twisting or crossing of the wire member 200. It is also expected that the intestinal bacteria can be injected into the intestine without removing the wire member 200 from the lumen of the tubular member 100.

[0042] The medical instrument 1 has the wire member 200 and the tubular member 100, and can therefore be used as an intestinal treatment device that administers intestinal bacteria to the distal side of the intestine over a long total length.

[0043] Furthermore, the position of the bending portion 240 in the longitudinal direction of the wire member 200 is configured to be displaceable with the support portion 250 as the base point. By configuring it in this way, the tubular member 100 can be advanced to the distal side of the intestine over its entire length using the wire member 200.

[0044] In addition, in a method for treating a lumen using the medical device 1, the wire member 200 is inserted into the lumen of a patient (first step). Then, with the support portion 250 in contact with the inner wall of the lumen, the wire member 200 is advanced toward the distal side of the lumen so as to change the position of the bent portion 240 in the longitudinal direction of the wire member 200, using the support portion 250 as a base point (second step).

[0045] Then, the tubular member 100 is inserted into the lumen along the wire member 200 so that the wire member 200 is positioned in the lumen of the tubular member 100 (third step). Then, an operation of pulling the wire member 200 is performed (fourth step).

[0046] By configuring it in this way, the wire member 200 and the tubular member 100 can be used to administer intestinal bacteria to the distal side of the intestine, which is complex and has a long overall length.

[0047] (Modification 1 of the first embodiment) 9 and 11 are views showing support portions 250a and 250b of wire members 200a and 200b according to Modification 1 of the first embodiment. Fig. 10 is a view showing a base portion of a protrusion 253 provided on a second portion 230 of a wire member 200a according to Modification 1 of the first embodiment.

[0048] In the first embodiment, it has been explained that the support portion 250 of the wire member 200 is formed so as to be curved at the tip end, but a protrusion can be provided at the tip end of the support portion as described below.

[0049] In this modification, the configuration of the tubular member 100 is the same as that of the first embodiment, and therefore a description thereof will be omitted.

[0050] The wire member 200a includes a proximal portion 210, a first portion 220, a second portion 230, a bending portion 240, and a support portion 250a. The proximal portion 210, the first portion 220, the second portion 230, and the bending portion 240 are the same as those in the first embodiment, and therefore description thereof will be omitted.

[0051] As shown in FIG. 9, the support portion 250a includes a curved portion 251, a connecting portion 252, and a protrusion 253.

[0052] The curved portion 251 is curved such that the tip side is spaced apart from the first portion 220 so that the protrusion 253 can easily come into contact with the inner wall of the intestine.

[0053] The connecting portion 252 is configured as a portion of the wire of the wire member 200a where the protrusion 253 is attached. It is preferable that the wire of the wire member 200a is bifurcated at the tip relative to the protrusion 253 and attached to the protrusion 253, as shown in Fig. 10. This configuration can further prevent the protrusion 253 from falling off the wire of the wire member 200a. The connecting portion 252 can be provided with irregularities for several centimeters from the base of the bifurcated portion to improve the visibility of ultrasonic echoes.

[0054] The protrusion 253 is provided at the end of the second portion 230 opposite the bent portion 240. The protrusion 253 can be configured to have a dimension larger than the wire diameter of the wire member 200a in a cross section perpendicular to the axis. By configuring it in this way, the contact area of ​​the portion where the support portion 250 comes into contact with the inner wall of the intestine can be relatively large.

[0055] The shape of protrusion 253 is not particularly limited as long as it is larger than the cross-sectional shape of the wire of wire member 200a, can easily stay on the wall surface of the intestine without slipping, and is difficult to come off the wire of the wire member. For example, the protrusion can be configured in a conical shape such as protrusion 253 shown in Fig. 9, or in a spherical shape such as protrusion 253b shown in Fig. 11.

[0056] The protrusion 253 is configured to include a water-absorbent swelling body such as gelatin or hydrogel that is larger than the lumen L of the tubular member 100, a balloon that can be expanded by supplying a fluid, or a sponge that can be stored in the lumen of the tubular member 100. When the protrusion is made of gelatin, the protrusion can be used by piercing the end of the wire of the wire member immediately before the start of the procedure.

[0057] When the protrusions 253, 253b are expandable balloons, the wire member can be provided with a shape having a lumen for supplying fluid to the protrusions 253, 253b from the base end (hand side) to the tip end so as to connect to the protrusions 253, 253b. By configuring in this way, when the protrusions 253, 253b of the wire members 200a, 200b include expansion balloons, the expansion balloons can be expanded or deflated as needed.

[0058] In the method for treating a lumen using a medical instrument including the wire member 200a or the wire member 200b according to the modification of the first embodiment, in S2 of Fig. 4, the surgeon operates the protrusion 253 or the protrusion 253b so as to hook it onto a fold in the inner wall of the large intestine. By operating in this manner, it becomes easier to advance the tip side of the wire member 200a or the wire member 200b distally. The rest is the same as in the first embodiment, and therefore a description thereof will be omitted.

[0059] As described above, the medical device according to this modification is configured so that the support portions 250a, 250b of the wire members 200a, 200b have the protrusions 253, 253b at the tip portions of the second section 230. This configuration makes it easier to increase the contact area between the support portions 250a, 250b and the inner wall of the intestine. This makes it easier to advance the tip sides of the wire members 200a, 200b distally into the intestine so as to change the position of the bending portion 240 using the support portions 250a, 250b as a base point.

[0060] Furthermore, protrusions 253, 253b can be configured to include gelatin, a water-absorbent swelling body, or an expansion balloon. By configuring in this way, it is possible to easily ensure the contact area between support parts 250a, 250b and the inner wall of the intestine.

[0061] Furthermore, when protrusions 253 are made of gelatin or a water-absorbent swelling body, protrusions 253, 253b are configured to be larger than lumen L of tubular member 100. By configuring in this manner, it is possible to easily ensure the contact area between protrusions 253, 253b and the inner wall of the intestine, as described above. Furthermore, when protrusions 253 are made of gelatin, even if protrusions 253 fall off inside the intestine, gelatin is broken down and absorbed in the intestine, so there is no harm to the health of the patient.

[0062] (Modification 2 of the first embodiment) 12 is a view showing a support portion 250c of a wire member 200c constituting a medical device according to Modification 2 of the first embodiment. Note that, since the tubular member in this modification is the same as that in the first embodiment, a description thereof will be omitted.

[0063] In this modification, the wire member 200c includes a proximal portion 210, a first portion 220, a second portion 230, a bending portion 240, and a support portion 250c. The proximal portion 210, the first portion 220, the second portion 230, and the bending portion 240 are the same as those in the first embodiment, and therefore description thereof will be omitted.

[0064] The wire member 200c has a substantially circular cross section perpendicular to its longitudinal axis. The wire member 200c is preferably made of a material that is easily bent. In this modification, the support portion 250c is configured so that the tip of the second section 230 has an uneven shape 253c as shown in FIG.

[0065] The unevenness 253c makes it easier for the support portion 250c to catch on the inner wall of the intestine when the tip of the wire member 200c is placed inside the intestine and the tip side of the wire member 200c is advanced distally of the large intestine so as to change the position of the bending portion 240 using the support portion 250c as a base point.

[0066] In the method for treating a lumen using the medical device according to the second modification of the first embodiment, the wire member 200c can function as an ultrasonic visual marker that makes it easier to confirm the position of the irregularities 253c of the support portion 250c under ultrasound when advancing the wire member 200c distally into the intestine. Since the other details are the same as those of the first embodiment, a description thereof will be omitted.

[0067] As described above, in this modification, support portion 250c is configured to have irregularities 253c on the surface at the tip of second section 230. This configuration makes it easier for support portion 250c to hook onto the inner wall of the intestine, making it easier to advance the tip side of wire member 200c toward the distal side of the large intestine so as to change the position of bending portion 240 using support portion 250c as a base point. In addition, irregularities 253c can function as an ultrasound visual marker under ultrasound, making it easier to grasp the position of support portion 250c.

[0068] (Second embodiment) 13 is a diagram showing a tubular member 100d and a wire member 200d that constitute a medical device 1d according to the second embodiment. In the first embodiment, the tubular member 100 is described as having the long portion 110, but the long portion may be provided with a balloon that can expand and contract by supplying and discharging a fluid.

[0069] The wire member 200d is configured so that the support portion 250d is not curved compared to the support portion 250, and the wire member 200d can be configured to include a plastic or metal material. If the wire member includes a metal, it is preferable that the surface is coated with a resin. It is also preferable that the wire member 200d has a tendency to bend. The wire member 200d includes a shape memory alloy or the like, and as long as it is bent when it advances through a lumen, it does not necessarily have to be bent when the medical device 1d is distributed (in its initial state at room temperature), and may be configured to have a straight shape.

[0070] Furthermore, notches can be provided on the inner surface of the bending portion 240 and on the support portion 250d around it, as shown in Figure 13. The notches can function as ultrasound visual markers. Furthermore, by providing notches, the wire member can bend in one direction, making it easier to maintain the bending portion. The other configurations are the same as those in the first embodiment, so a description thereof will be omitted.

[0071] The tubular member 100d includes a long section 110d, a proximal section 120d, a first introduction section 130d, a second introduction section 140d, and a third introduction section 150, as shown in FIG.

[0072] As shown in FIGS. 13 and 14, the long portion 110d is configured to include a first tubular portion 111d, a second tubular portion 112d, a third tubular portion 113d, and an expansion portion 114d (corresponding to an expansion balloon).

[0073] The first tubular portion 111d is configured to have a first lumen 115d through which intestinal bacteria can flow, as shown in Fig. 14. The first lumen 115d is configured to have a second tubular portion 112d and a third tubular portion 113d disposed therein.

[0074] The second tubular portion 112d is configured to have a second lumen 116d through which the wire member 200d can be inserted. The third tubular portion 113d is connected to the expansion portion 114d and is configured to have a third lumen 117d through which a fluid that expands and contracts the expansion portion 114d can flow.

[0075] The expansion section 114d is provided on the distal end side in the longitudinal direction outside the first tubular section 111d, and is configured to connect to the third tubular section 113d provided with the third lumen 117d. With this configuration, the expansion section 114d can be expanded by supplying fluid to the third lumen 117d of the third tubular section 113d, and can be contracted by exhausting the fluid.

[0076] 18, the expansion section 114d is configured so as to be able to come into contact with the support section 250d when expanded with a portion of the wire member 200d disposed in the lumen of the tubular member 100d and the support section 250d disposed outside the tubular member 100d. The expansion section 114d is configured so as to be able to expand to an extent that it separates the space on the forward side and the space on the proximal side of the lumen in the intestine when expanded within the lumen.

[0077] The proximal portion 120d is configured to be grippable by the fingers of the surgeon, as in the first embodiment. The proximal portion 120d is configured to be provided with a first introduction portion 130d, a second introduction portion 140d, and a third introduction portion 150. The proximal portion 120d is configured to be hollow and to be provided with a first lumen 115d, a second lumen 116d, and a third lumen 117d.

[0078] The first introduction section 130d is connected to the first tubular section 111d, and its internal space communicates with the first lumen 115d, forming an introduction site for the intestinal bacteria. As in the first embodiment, the first introduction section 130d is configured so that the introduction direction of the intestinal bacteria is oblique to the axial direction of the proximal section 120d. In this embodiment, the first introduction section 130d is provided closer to the base end (proximal side) than the third introduction section 150.

[0079] Second introduction section 140d is connected to second tubular section 112d and is configured to have a hole communicating with second lumen 116d. With this configuration, wire member 200d can be introduced into second lumen 116d through the hole of second introduction section 140d.

[0080] Third introduction section 150 is connected to third tubular section 113d, and its internal space is configured to communicate with third lumen 117d, thereby enabling fluid to be supplied to and discharged from expansion section 114d. As an example, third introduction section 150 is configured in a cylindrical shape, such as a cylinder, and the axis of the cylindrical shape is configured to be oblique to the axis of proximal section 120d, similar to first introduction section 130d.

[0081] (Treatment method) Next, a method for treating a lumen using the medical device 1d according to this embodiment will be described. FIG. 15 is a flowchart showing the method for treating a lumen using the medical device according to this embodiment, and FIGS. 16 to 21 are views showing the state in which the medical device according to this embodiment has been introduced into the intestine. Note that the insertion of the wire member 200d into the patient's lumen (first step, S11, see FIG. 16) is similar to S1 (see FIG. 4) in the first embodiment, and therefore description thereof will be omitted. Normally, the medical device is advanced into the lumen using the method shown in FIGS. 5 to 8 described above. Then, when it becomes impossible to advance the wire member further distally within the lumen using the normal method, the medical device is advanced into the lumen using the method shown in FIGS. 16 to 21, as will be described below.

[0082] That is, the surgeon brings the support portion 250d of the wire member 200d into contact with the inner wall of the intestine. Then, with the support portion 250d in contact with the inner wall of the intestine as in the first embodiment, the surgeon advances the tip side of the wire member 200d distally so as to change the position of the bending portion 240 with the support portion 250d as the base point (S12).

[0083] After the wire member 200d has been advanced to the distal side of the large intestine so as to change the position of the bending portion 240, the surgeon advances the tubular member 100d along the wire member 200d to the distal side of the large intestine so that the wire member 200d is positioned in the lumen of the tubular member 100d, as in Figure 7 (S13).

[0084] Here, the surgeon determines whether or not the wire member 200d can be advanced inside the lumen to determine whether or not to use the expansion section 114d (S14). If the wire member 200d can be advanced inside the lumen (S14; NO), the surgeon pulls the wire member 200d toward the operator while preventing the position of the tubular member 100d in the longitudinal direction from moving, as in the first embodiment (S15).

[0085] The surgeon repeats steps S12 to S15 until the tip of the long portion 110d of the tubular member 100d reaches the desired position in the intestine where the intestinal bacteria is to be administered (S16; NO).

[0086] Once it is confirmed that the distal end of the tubular member 100d has reached the target site in the intestine (S16; YES), the surgeon removes the wire member 200d from the body lumen. Then, with the second introduction section 140d sealed with a seal member or the like, the surgeon introduces the intestinal bacteria from the first introduction section 130d and administers the intestinal bacteria from the distal end of the tubular member 100d (S22). After administration of the intestinal bacteria is completed, the surgeon removes the tubular member 100d from the intestine (S23).

[0087] On the other hand, if the wire member 200d cannot be advanced through the lumen in S14 (S14; YES), the surgeon advances the tubular member 100d distally using the expansion portion 114d as described below.

[0088] That is, the surgeon advances the tubular member 100d toward the distal side of the patient's lumen along the wire member 200d with the expansion portion 114d contracted so that the expansion portion 114d comes into contact with the support portion 250d when expanded, as shown in Figure 17 (second step, S17).

[0089] After moving the tubular member 100d to the above position, the surgeon connects the third introduction section 150 to an indeflator (not shown) or the like, and supplies fluid to the expansion section 114d through the third lumen 117d to expand the expansion section 114d. As a result, the support section 250d comes into contact with the expansion section 114d and also comes into contact with the inner wall of the lumen in the intestine, as shown in Figure 18, and the support section 250d is fixed to the intestine or its movement is restricted.

[0090] Next, the surgeon advances the tip side of the wire member 200d toward the distal side of the large intestine so as to change the position of the bending portion 240 based on the support portion 250d, which is fixed within the intestine by the expansion portion 114d or is prevented from moving longitudinally within the intestine (third step, S18), as shown in Figure 19.

[0091] After advancing the wire member 200d a predetermined distance distal to the large intestine, the surgeon contracts the expansion portion 114d as shown in FIG. 20 and advances the tubular member 100d along the wire member 200d distal to the large intestine (fourth step, S19).

[0092] Thereafter, the surgeon pulls the wire member 200d toward the proximal end so as to move the support portion 250d toward the distal side of the large intestine in the longitudinal direction as shown in FIG. 21 (fifth procedure, S20).

[0093] Thereafter, the operations of S18 to S20 are repeated until the tip of the long portion 110d of the tubular member 100d reaches the site where the intestinal bacteria is to be administered (S21; NO).

[0094] When the distal end of the long portion 110d of the tubular member 100d reaches the target site in the intestine (S21; YES), the surgeon removes the wire member 200d from the intestine. Next, the surgeon expands the expansion portion 114d to isolate the space on the forward side of the tubular member 100d from the space on the proximal side, and administers the intestinal bacteria into the intestine through the first lumen 115d of the long portion 110d of the tubular member 100d (S22). By administering the intestinal bacteria into the intestine while the expansion portion 114d is expanded, it is possible to prevent or suppress the distribution of the intestinal bacteria into the intestine on the proximal side of the expansion portion 114d.

[0095] The intestinal bacteria may be administered multiple times by changing the position of the tubular member 100d in the intestine when the tubular member 100d is pulled back proximally toward the anus, as in the first embodiment. After the administration of the intestinal bacteria is completed, the surgeon removes the tubular member 100d from the intestine (S23).

[0096] As described above, the tubular member 100d is configured to have an expansion portion 114d on the outside thereof. The expansion portion 114d is configured so that a portion of the wire member 200d is disposed in the second lumen 116d of the tubular member 100d and can come into contact with the support portion 250d when the expansion portion 114d is expanded while the support portion 250d is disposed outside the tubular member 100d. This configuration makes it easier to fix the support portion 250d of the wire member 200d in the intestine in order to advance the tubular member 100d distally.

[0097] The expansion section 114d is configured to be expandable to an extent that it separates the space on the advancing side of the intestine from the space on the proximal side. Furthermore, during treatment of the lumen, the expansion section 114d is expanded within the lumen, and intestinal bacteria are administered to the lumen in a state in which the space on the advancing side of the tubular member 100d in the lumen is separated from the space on the proximal side. This configuration makes it possible to prevent or inhibit the intestinal bacteria from circulating to the proximal side of the intestine when administering the intestinal bacteria to the intestine.

[0098] In addition, in a method for treating a lumen using the medical device 1d, the wire member 200d is inserted into the lumen of a patient (first step). Next, the wire member 200d is positioned in the lumen of the tubular member 100d, and the expansion section 114d is contracted so that the expansion section 114d comes into contact with the support section 250d when expanded. In this state, the tubular member 100d is inserted into the lumen of the patient along the wire member 200d (second step).

[0099] Next, the expansion section 114d is expanded to bring the expansion section 114d into contact with the support section 250d. Then, with the support section 250d in contact with the inner wall of the lumen, the tip side of the wire member 200d is advanced distally into the lumen so as to change the position of the bent section 240 in the longitudinal direction of the wire member 200d, using the support section 250d as a base point (third step).

[0100] Next, the expansion portion 114d is contracted, and the tubular member 100d is advanced to the distal side of the lumen along the wire member 200d (fourth step). Next, the wire member 200d is pulled so as to move the support portion 250d to the distal side of the lumen (fifth step).

[0101] In this manner, by repeating the operations of expanding and contracting the expansion portion 114d and moving the position of the support portion 250d of the wire member 200d within the intestine, the tip of the long portion 110d of the tubular member 100d can be advanced to the distal side of the intestine within the complex and long intestine.

[0102] In the above embodiment, an example in which the medical device is used in the large intestine has been described, but the medical device of the present invention can also be used in biological lumens other than the large intestine, such as veins, etc. However, the medical device of the present invention is particularly suitable for biological lumens such as the large intestine, which have large bending sections and a large degree of flattening of the cross section, making it difficult to advance the medical device deep into the lumens.

[0103] The present invention is not limited to the above-described embodiment, and various modifications are possible within the scope of the claims. In the second embodiment, the support portion 250d of the wire member 200d is described as being substantially linear, but the present invention is not limited to this, and a medical device may be configured by combining the tubular member 100d of the second embodiment with the wire member 200 of the first embodiment.

[0104] This application is based on Japanese Patent Application No. 2021-004790, filed on January 15, 2021, the disclosure of which is incorporated by reference in its entirety. [Explanation of symbols]

[0105] 1, 1d medical equipment, 100, 100d tubular members; 114d expansion part (expansion balloon), 200, 200a, 200b, 200c, 200d wire members, 210 hand part, 220 Part 1, 230 Part 2, 240 bends, 250, 250a, 250b, 250c, 250d support part, 253, 253b protrusion; 253c unevenness, L Lumen.

Claims

1. a hollow tubular member insertable into a lumen of a patient; a long wire member that can be inserted into the lumen of the tubular member, The wire member has a handle portion that can be held by a user; a bending portion provided at a distal end portion opposite the proximal portion in the longitudinal direction, the bending portion bending the wire at the distal end portion so that the wire can be deformed when the wire advances through the lumen; a first section from the grip portion to the bent portion; a second portion provided so as to be folded back from the bent portion; a support portion provided in the second portion and capable of contacting an inner wall of a lumen, The support portion is a medical device in which the support portion is curved at the distal end of the second portion so as to be away from the first portion in a direction intersecting the longitudinal direction.

2. A hollow tubular member that can be inserted into a patient's lumen; a long wire member that can be inserted into the lumen of the tubular member, The wire member has a handle portion that can be held by a user; a bending portion provided at a distal end portion opposite the proximal portion in the longitudinal direction, the bending portion bending the wire at the distal end portion so that the wire can be deformed when the wire advances through the lumen; a first section from the grip portion to the bent portion; a second portion provided so as to be folded back from the bent portion; a support portion provided in the second portion and capable of contacting an inner wall of a lumen, the support portion is a protrusion provided at a tip end portion of the second portion, The medical device wherein the protrusion is a gelatin, a water-absorbent swelling body, or an expansion balloon.

3. A hollow tubular member that can be inserted into a patient's lumen; a long wire member that can be inserted into the lumen of the tubular member, The wire member has a handle portion that can be held by a user; a bending portion provided at a distal end portion opposite the proximal portion in the longitudinal direction, the bending portion bending the wire at the distal end portion so that the wire can be deformed when the wire advances through the lumen; a first section from the grip portion to the bent portion; a second portion provided so as to be folded back from the bent portion; a support portion provided in the second portion and capable of contacting an inner wall of a lumen, the support portion is a protrusion provided at a tip end portion of the second portion, the protrusions are gelatin or water-absorbent swollen bodies, The medical device wherein the protrusion is larger than the lumen of the tubular member.

4. The medical device according to any one of claims 1 to 3, wherein the second portion has a cross section perpendicular to the longitudinal axis that has an elliptical or flattened shape.

5. A hollow tubular member insertable into a lumen of a patient; a long wire member that can be inserted into the lumen of the tubular member, The wire member has a handle portion that can be held by a user; a bending portion provided at a distal end portion opposite the proximal portion in the longitudinal direction, the bending portion bending the wire at the distal end portion so that the wire can be deformed when the wire advances through the lumen; a first section from the grip portion to the bent portion; a second portion provided so as to be folded back from the bent portion; a support portion provided in the second portion and capable of contacting an inner wall of a lumen, The device further includes an expandable and contractable dilatation balloon provided on the outside of the tubular member, The expansion balloon is a medical device in which a portion of the wire member is positioned in the lumen of the tubular member and the support portion is capable of contacting the support portion when expanded with the support portion positioned outside the tubular member.

6. The medical device according to claim 5, wherein the expansion balloon is expandable to such an extent that when expanded within the lumen, it separates a space on the forward side of the tubular member from a space on the proximal side of the lumen.

7. the lumen is the intestine; The medical instrument according to any one of claims 1 to 6, which is used as an intestinal treatment device.

8. The medical device according to any one of claims 1 to 7, wherein the position of the bent portion in the longitudinal direction of the wire member is displaceable with the support portion as a base point.

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