WO2021199933A1

WO2021199933A1 - Medical instrument and medical instrument set

Info

Publication number: WO2021199933A1
Application number: PCT/JP2021/008959
Authority: WO
Inventors: 直希荒巻; 美穂甲斐; 昭宏高橋; 智哉小松; 由紀子田邊; 浩一早川
Original assignee: テルモ株式会社
Priority date: 2020-03-30
Filing date: 2021-03-08
Publication date: 2021-10-07
Also published as: JPWO2021199933A1; CN114929299A

Abstract

A medical instrument 200 according to the present invention has a main body portion 210 that is positioned between the pancreatic parenchyma B1 and the jejunum B2 and is equipped with a lumen L, and a fixing portion 220 that generates a fixing force for configuring the main body portion so as to be fixable to the pancreatic parenchyma B1, the fixing portion being configured so that the outer shape can be expanded by an external force.

Description

Medical equipment and medical equipment set

The present invention relates to a medical device and a medical device set.

As one of the techniques for joining a pair of biological organs by surgical operation (for example, gastrointestinal anastomosis), a technique for joining the pancreatic parenchyma and the jejunum is known. Pancreaticoduodenectomy, in which the pancreatic head and its surrounding tissues are resected, is known as one of the treatment methods for tumors near the pancreatic head. After pancreaticoduodenectomy, a procedure is performed to join the pancreatic parenchyma and the jejunum.

In the procedure for joining the pancreatic parenchyma and the jejunum, the pancreatic parenchyma and the jejunum are sutured by a suture member such as a biodegradable suture. In addition, in the procedure for joining the pancreatic parenchyma and the jejunum, a pancreatic duct tube (see, for example, Patent Document 1 below) is used to prevent pancreatic juice discharged from the pancreatic duct from leaking to the junction where the pancreatic parenchyma and the jejunum are joined. May be done. The pancreatic duct tube is placed in a living body in a state where one end of the pancreatic duct tube is inserted into the pancreatic duct and the other end of the pancreatic duct tube is led out to the outside of the body via the inside of the jejunum or the like. The indwelling pancreatic duct tube suppresses leakage to the joint by draining pancreatic juice discharged from the pancreatic duct to the outside of the body.

JP-A-2007-167540

The present inventors are diligently studying a medical device that can easily join a pair of gastrointestinal tracts such as the jejunum and the pancreatic parenchyma.

Therefore, an object of the present invention is to provide a medical device capable of easily joining a pair of digestive tracts.

The medical device according to the present invention that achieves the above object is arranged between a pair of gastrointestinal tracts to be joined, and is configured so that the tubular member having a lumen and the tubular member can be fixed to at least one gastrointestinal tract. It has a fixing portion for generating a fixing force for the purpose, and the fixing portion is configured so that its outer shape can be expanded by an external force.

Since the medical device and the medical device set according to the present invention are configured as described above, a pair of digestive tracts can be easily joined.

It is a figure which shows the medical device set which concerns on one Embodiment of this invention. It is an enlarged cross-sectional view which shows the through hole of the fusion promotion sheet which constitutes a medical device set. It is a side view for showing the fixed part of the medical device which concerns on FIG. It is a side view for showing the expanded state of the fixed part of the medical device which concerns on FIG. FIG. 5 is an enlarged cross-sectional view taken along line 5-5 of FIG. It is the schematic for showing the modification of the hole part which constitutes a fixed part. It is sectional drawing for showing the expanded state of the fixed part of the medical device which concerns on FIG. It is the schematic for showing the modification of the hole part which constitutes a fixed part. It is the schematic for showing the modification of the hole part which constitutes a fixed part. FIG. 5 is a cross-sectional view for showing an expanded state of a fixed portion of the medical device according to FIG. It is the schematic for showing the modification of the hole part which constitutes a fixed part. It is a side view for showing the expanded state of the fixed part of the medical device which concerns on FIG. It is a schematic diagram for showing the modification 1 of the medical device which concerns on FIG. It is a side view for showing the expanded state of the fixed part of the medical device which concerns on FIG. It is a schematic diagram for showing the modification 2 of the medical device which concerns on FIG. It is the schematic for showing the expanded state of the fixed part of the medical device which concerns on FIG. It is a schematic diagram for showing the modification 3 of the medical device which concerns on FIG. It is a side view for showing the expanded state of the fixed part of the medical device which concerns on FIG. It is a flowchart which shows each procedure of the treatment method using a medical device. It is a flowchart which shows the procedure of embodiment (pancreatic parenchymal-jejunal anastomosis) of the treatment method. FIG. 6 is a schematic cross-sectional view for explaining pancreatic parenchymal-jejunal anastomosis. FIG. 6 is a schematic cross-sectional view for explaining pancreatic parenchymal-jejunal anastomosis. FIG. 6 is a schematic cross-sectional view for explaining pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. FIG. 6 is a schematic cross-sectional view for explaining pancreatic parenchymal-jejunal anastomosis. It is a figure which shows the medical device set when the fixed part is formed at both ends of the medical device. FIG. 2 is a schematic cross-sectional view for explaining pancreatic parenchymal-jejunal anastomosis using the medical device set shown in FIG. 27.

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

<First Embodiment>
<Medical equipment set 1>
FIG. 1 is a diagram provided for explaining a medical device set 1 according to an embodiment of the present invention.

As shown in FIGS. 21 to 26, the medical device set 1 can be applied to a procedure for joining predetermined biological organs (for example, gastrointestinal anastomosis). As will be described later, in the description of the present specification, a pancreatic parenchymal-jejunal anastomosis technique for joining the pancreatic parenchyma B1 and the jejunum B2 will be described as an example of a procedure using the medical device set 1.

The medical device set 1 has a fusion promoting sheet 100 and a medical device 200.

<Union promotion sheet 100>
FIG. 2 is an enlarged cross-sectional view showing a through hole 112 of the fusion promoting sheet 100 constituting the medical device set 1.

As shown in FIG. 1, the fusion promoting sheet 100 is formed of a biodegradable sheet having a plurality of through holes 112 and has a main body portion 110 that promotes fusion of living tissues.

As shown in FIGS. 1 and 2, the main body 110 is composed of a sheet-shaped member.

As shown in FIGS. 1 and 2, each through hole 112 formed in the main body 110 is regularly and periodically provided in the plane direction of the main body 110. However, each through hole 112 may be randomly provided in each portion in the surface direction of the main body portion 110.

As shown in FIG. 2, each through hole 112 extends substantially vertically between the front surface 111 and the back surface 113 along the thickness direction of the main body 110 (vertical direction in FIG. 2). Each through hole 112 may be bent or curved in a zigzag shape between the front surface 111 and the back surface 113 in a cross section along the thickness direction of the main body 110.

Each through hole 112 has a substantially circular planar shape (the shape when the front surface 111 of the main body 110 or the back surface 113 of the main body 110 is viewed in a plan view). However, the planar shape of each through hole 112 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.). Further, the plane shape and the cross-sectional shape may be different for each through hole 112.

The main body 110 has a substantially circular planar shape. However, the planar shape of the main body 110 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.). Further, the plane shape and the cross-sectional shape may be different for each through hole 112.

The thickness of the main body 110 (dimension T shown in FIG. 2) is not particularly limited, but is preferably 0.05 mm to 0.3 mm, more preferably 0.1 to 0.2 mm. When the thickness of the main body 110 is 0.05 mm or more (particularly 0.1 mm or more), the strength is such that the main body 110 is not damaged when the fusion promoting sheet 100 is handled. On the other hand, when the thickness of the main body 110 is 0.3 mm or less (particularly 0.2 mm or less), the main body 110 adheres to the biological tissue to which the main body 110 is applied and follows the biological tissue. It can be provided with sufficient flexibility.

The main body 110 has a value of the ratio of the hole diameter D of the through hole 112 to the pitch P of the through hole 112 (distance between adjacent through holes 112 as shown in FIG. 2) of 0.25 or more and less than 40. Is preferable. When the planar shape of the through hole 112 is a perfect circle, the hole diameter D of the through hole 112 is equal to the diameter of the perfect circle. On the other hand, when the planar shape of the through hole 112 is not a perfect circle, the diameter of a perfect circle (circle) having the same area as the area of the opening of the through hole 112 (the portion of the through hole 112 facing the front surface 111 or the back surface 113). The equivalent diameter) can be the hole diameter D of the through hole 112.

Since the main body 110 has a plurality of through holes 112, there are a plurality of values of the hole diameter D corresponding to each through hole 112. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the hole diameter D values corresponding to the plurality of through holes 112 is used as the representative value of the hole diameter D. .. On the other hand, the pitch P of the plurality of through holes 112 is defined by the shortest distance between the openings of the two through holes 112. However, as for the value of the pitch P, there are a plurality of values of the pitch P corresponding to the combination of the adjacent through holes 112. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the pitch P values corresponding to the combinations of the adjacent through holes 112 is used as the representative value of the pitch P. And.

The pitch P, the hole diameter D, the ratio of the hole diameter D to the pitch P, and the like of the through hole 112 are examples, and are not limited thereto.

The main body 110 can be made of a biodegradable material. The constituent material of the main body 110 is not particularly limited, and examples thereof include biodegradable resins. As the biodegradable resin, for example, those described in Japanese Patent Publication No. 2011-528275, Japanese Patent Publication No. 2008-514719, International Publication No. 2008-1952, Japanese Patent Publication No. 2004-509205 and the like are known. Biodegradable (co) polymers can be used. Specifically, it is selected from the group consisting of (1) aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. Polymer; (2) A copolymer composed of one or more monomers constituting the above (1) and the like can be mentioned. That is, the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and celluloses. It preferably contains at least one biodegradable resin selected from the group consisting of a polymer and a copolymer composed of one or more monomers constituting the polymer.

The manufacturing method of the main body 110 is not particularly limited, and examples thereof include a method of manufacturing a fiber made of the above-mentioned biodegradable resin and manufacturing a mesh-shaped sheet using the fiber. The method for producing the fiber made of a biodegradable resin is not particularly limited, and examples thereof include an electrospinning method (electrospinning method / electrostatic spinning method) and a melt blow method. As the main body 110, only one type may be selected and used from the above methods, or two or more types may be selected and appropriately combined. As yet another example of the method for manufacturing the main body 110, the biodegradable sheet according to the present invention is obtained by spinning the fibers made of the biodegradable resin described above according to a conventional method and knitting the obtained fibers into a mesh shape. Members may be manufactured.

The main body 110 induces a biological reaction by the constituent material of the biodegradable resin constituting the main body 110. The main body 110 induces the expression of biological components such as fibrin by this action. The biological components induced in this way can promote fusion by accumulating so as to penetrate through the through hole 112 of the main body 110. Therefore, by arranging the main body 110 between the pancreatic parenchyma B1 and the jejunum B2, promotion of fusion by the above mechanism can occur.

The material of the fusion promoting sheet 100 does not have to be biodegradable as long as it can promote the fusion of biological organs. Further, the fusion promoting sheet 100 may not have a through hole 112 formed regardless of the material, as long as it can promote the fusion of living organs.

<Medical device 200>
Next, the medical device 200 will be described. The medical device 200 is used to maintain a state in which the lumens of the pair of gastrointestinal tracts to be joined are in communication, such as the pancreatic parenchyma B1 and the jejunum B2. 3 to 12 are diagrams for explaining the medical device 200.

In the following description, the one end side of the medical device 200 that can be inserted into the jejunum B2 is referred to as the "base end side", and the other end side of the medical device 200 that can be inserted into the pancreatic parenchyma B1 is referred to as the "tip side". Further, the direction from the tip end side to the base end side (or the opposite direction) is referred to as an axial direction X.

The medical device 200 is attached to the main body 210 (corresponding to a “tubular member”) arranged between the digestive tracts (pancreatic parenchyma B1 and jejunum B2) to be joined, and at least one gastrointestinal tract (pancreatic parenchyma B1). On the other hand, the fixing portion 220 that generates a fixing force for forming the main body portion 210 so that it can be fixed, the operating portion 230 that deforms the fixing portion 220 by transmitting an external force to the fixing portion 220, and the operating portion 230 that the operating portion 230 fixes the fixing portion 220. It has an auxiliary unit 240 that maintains a state in which an external force is transmitted to the pancreas.

<Main body 210>
The main body 210 includes a lumen L. In the present embodiment, the shape of the hollow cross section is configured as a circular shape such as a perfect circle or an ellipse. The outer diameter r1 and inner diameter of the main body 210 are not particularly limited, but are preferably 3 Fr (outer diameter 1.0 mm, inner diameter 0.5 mm) to 15 Fr (outer diameter 5.0 mm, inner diameter 3.0 mm), and more preferably. It is 4 Fr (outer diameter 1.3 mm, inner diameter 0.7 mm) to 6 Fr (outer diameter 2.0 mm, inner diameter 1.4 mm).

When the main body 210 is arranged between the pancreatic parenchyma B1 and the jejunum B2, the pancreatic juice is introduced into the lumen L from the distal opening 210A, and the pancreatic juice is drained from the proximal opening 210B to the jejunum B2.

The main body 210 can be made of an elastic, non-biodegradable material. The main body 210 spontaneously falls off into the jejunum B2 after a predetermined period (weeks to months) has passed since the operator anastomosed the digestive tract and placed the main body 210 in the living body, and the main body 210 was in vitro. Derived to. That is, the main body 210 functions as a so-called internal fistula tube.

As shown in FIGS. 1 and 3, the main body 210 is provided with at least one side hole 210P on the tip side. When the side hole 210P is arranged between the pancreatic parenchyma B1 and the jejunum B2, the pancreatic juice is introduced into the lumen L and drained into the jejunum B2. Therefore, the side hole 210P can drain pancreatic juice into the jejunum B2 even when the distal end side opening 210A is occluded.

The constituent materials of the main body 210 are not particularly limited, and are, for example, vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS). It can be composed of a thermoplastic elastomer such as, nylon, a thermoplastic resin such as PET, rubber, a silicone elastomer or the like.

<Fixed part 220>
As shown in FIGS. 3 and 4, the fixing portions 220 are a plurality of holes 221 provided in a certain area on the tip end side of the main body 210, and a plurality of fixed portions 220 arranged between the holes 221 respectively. It is composed of a beam portion 222 of the above.

As shown in FIG. 4, when the fixing portion 220 is compressed in the axial direction X by an external force, each of the beam portions 222 is bent outward in the radial direction (diameter direction), whereby the outer diameter (outer diameter) of the medical instrument 200 is obtained. r1) can be expanded into a circular shape (radial) (see FIG. 5).

As shown in FIGS. 4, 5, 7, and 10, each of the holes 221 is bent outward in the radial direction (diameter direction) to expose the exposed surface 221 m.

By expanding the outer diameter r1 of the medical device 200, the fixing portion 220 can expand the inner wall of the pancreatic duct B1b to increase the fitting force (resistance force) of the medical device 200 with respect to the pancreatic parenchyma B1. Therefore, the fixing portion 220 can fix the main body portion 210 to the pancreatic duct B1b.

The surgeon inserts the medical device 200 into the pancreatic duct B1b once, fixes the main body 210 to the pancreatic duct B1b by the fixing portion 220, and the medical device 200 is inserted into the cavity of the pancreatic parenchyma B1 (pancreatic duct B1b). The state can be maintained. Further, the surgeon moves the circumference of the cut surface B1a of the pancreatic parenchyma B1 (anterior wall B1d and posterior wall B1c) and the jejunum B2 without inserting and removing the medical device 200 from the pancreatic duct B1b, and moves the pancreatic parenchyma B1 and the jejunum. B2 can be joined. Therefore, the operator can perform anastomosis between the pancreatic parenchyma B1 and the jejunum B2 without suturing the pancreatic duct B1b and the jejunum B2, and can easily join the pancreatic parenchyma B1 and the jejunum B2.

As shown in FIG. 5, the hole portion 221 and the beam portion 222 are each provided at eight locations. Further, each of the hole portions 221 (and each of the beam portions 222) is provided at a predetermined interval with respect to the circumferential direction θ of the fixed portion 220. The number of holes 221 and beam 222 is not particularly limited, and preferably 2 to 16 holes, more preferably 4 to 8 holes, respectively.

The hole portion 221 is a linear cut (slit) formed in the main body portion 210. Each length k of the hole 221 along the longitudinal direction is the same or substantially the same as shown in FIG. 3, preferably 3 to 8 mm. The method for producing the hole 221 is not particularly limited, but the hole 221 can be produced, for example, by laser processing.

As shown in FIG. 3, the hole portion 221 is formed so as to intersect in the axial direction X. The inclination angle θ1 of the hole portion 221 with respect to the axial direction X (the inclination angle of the virtual line m1 from the start point 221a to the end point 221b of the hole portion 221 with respect to the axial direction X) is preferably 0 to 89 °, more preferably 17 to 45 °. Is.

Further, the outer diameter r2 (see FIG. 4) of the fixed portion 220 after expansion is preferably 2 to 4 times the inner diameter of the pancreatic duct B1b. When the inner diameter of the pancreatic duct B1b is 2 mm, the outer diameter r2 of the fixed portion 220 after expansion is preferably 4 to 8 mm, more preferably 5 mm.

By adjusting the length k and the inclination angle θ1 of the hole 221, the surgeon changes the outer diameter r2 after the diameter of the fixing portion 220 is expanded so that the main body 210 can be fixed to the digestive tract. (Hereinafter referred to as the fixing force of the medical device 200) can be adjusted.

The fixing force of the medical device 200 after expansion is preferably 1.1 to 4 times that before expansion. The fixing force is constant after inserting the medical device 200 into the pancreatic parenchyma B1 and expanding the outer diameter r1 of the medical device 200 by the fixing portion 220, and then grasping the proximal end side of the medical device 200 with forceps or the like. Maximum strength when pulled at speed. When the fixing force before expansion is 1.2 to 1.7N, the fixing force after expansion is preferably 2 to 5N.

Further, although it was explained that the hole portion 221 is linear, the shape of the hole portion 221 is not particularly limited. The hole 221 may have a curved shape (see FIG. 6) such as an elliptical arc. By making the shape of the hole 221 curved like an elliptical arc, it is possible to adjust the shape of the beam portion 222 as seen from the axial direction X when the fixed portion 220 is compressed in the axial direction X by an external force. Yes (see FIGS. 5 and 7). Therefore, the operator can adjust the contact amount (contact point) between the inner wall of the pancreatic duct B1b and the beam portion 222, and adjust the fixing force of the medical device 200 to the digestive tract.

Further, the hole portion 221 may have a polygonal line shape (see FIG. 8) formed by combining a plurality of straight lines. The angle (inclination angle θ2) of the hole portion 221 with respect to the virtual line m1 on the start point 221a side is preferably larger than the angle (inclination angle θ3) of the end point 221b side of the hole portion 221 with respect to the virtual line m1. In this case, when the beam portion 222 is compressed in the axial direction X by an external force, the beam portion 222 is inclined and bent toward the proximal end side when viewed from a direction orthogonal to the axial direction X. Therefore, the fixing portion 220 can be expected to generate more fixing force of the medical device 200 to the digestive tract.

Further, the hole 221 may be spiral.

Further, the direction in which the hole 221 extends is not particularly limited.

Further, the arrangement of each of the holes 221 is not particularly limited. As shown in FIG. 4, each of the start point 221a (or end point 221b) of the hole portion 221 is arranged so as to be aligned with the circumferential direction θ of the main body portion 210 (at the same position with respect to the axial direction X of the main body portion 210). Alternatively, as shown in FIG. 9, they may be arranged in a zigzag shape (positions different from each other with respect to the axial direction X of the main body 210).

As shown in FIG. 9, when each of the hole portions 221 is arranged at different positions with respect to the axial direction X of the main body portion 210, the fixing portion 220 is compressed in the axial direction X by an external force. As shown in FIG. 10, the outer shape of the medical device 200 can be expanded into a substantially rectangular shape.

Further, as shown in FIG. 11, one or more hole portions 223 having a length shorter than that of the hole portion 221 may be formed on the base end side of the beam portion 222. The base end side of the beam portion 222 is more flexible than the tip end side where the hole portion 223 is not formed due to the formation of the hole portion 223. Therefore, when the beam portion 222 is compressed in the axial direction X by an external force, the beam portion 222 is at a position where the hole portion 221 is formed (the starting point 221a of the hole portion 221 with respect to the axial direction X) when viewed from a direction orthogonal to the axial direction X. From the virtual line m2 indicating the position to the virtual line m3 indicating the end point 221b), the beam is inclined toward the base end and bent (see FIG. 12). Therefore, the fixing portion 220 can be expected to generate more fixing force of the medical device 200 to the digestive tract.

<Operation unit 230, auxiliary unit 240>
As shown in FIGS. 1, 3, and 4, the operation unit 230 is a connection that enables the connection between the towing unit 250 that applies an external force to the fixing unit 220 by being towed and the towing unit 250 to the main body unit 210. It has a part 260 and. Further, as shown in FIG. 4, the auxiliary portion 240 has a hole portion 270 (“insertion hole”) that exposes the traction portion 250 that is at least partially inserted into the lumen L of the main body portion 210 starting from the connection portion 260. Correspondingly), and a locking portion 280 configured so that at least a part of the traction portion 250 can be locked to the hole portion 270.

The traction portion 250 has a predetermined length and has a long-shaped member having a cross-sectional shape that can be inserted into the lumen L of the main body portion 210 and the hole portion 270 (for example, a small-diameter string-shaped member or a predetermined width). It can be composed of a band-shaped member having the above. There is no particular limitation on the length of the towed portion 250 and the like.

The connection portion 260 is formed at the tip of the main body portion 210. The method of fixing the base end of the traction portion 250 to the tip end side of the main body portion 210 is not particularly limited, but it can be fixed by suture or adhesive, connected by fusion or the like, or one end of the traction portion 250 has a ring shape. It can be tied to and hooked on the tip of the main body 210.

The hole 270 is formed in the main body 210 and is arranged on the base end side (center side from the fixed portion 220 formed on one end side of the main body 210) with respect to the fixed portion 220 formed at the tip end. The traction portion 250 in the present embodiment is inserted into the lumen L of the main body portion 210 from the connection portion 260 formed at the tip of the main body portion 210 to the hole portion 270 formed on the base end side of the main body portion 210. An external force can be applied to the fixed portion 220 by being pulled. Therefore, the operator can deform the fixed portion 220 without directly applying an external force to the fixed portion 220. Further, the operator can adjust the position of pulling the towing portion 250 according to the procedure by providing the hole portion 270 on the side surface of the main body portion 210.

The surgeon pulls the traction portion 250 (applies axial X tension to the traction portion 250) with at least a part of the traction portion 250 inserted through the lumen L of the main body portion 210 to the fixed portion 220. An external force can be applied to compress the fixing portion 220 in the axial direction X.

The locking portion 280 is one or more protrusions provided in a certain range of the traction portion 250. Each of the locking portions 280 is made of an elastic material, and when a tension of a predetermined value or more is applied to the traction portion 250, the locking portion 280 elastically deforms to pass through (overcome) the hole portion 270 or to the hole portion 270. It can be locked. The shape (cross-sectional shape) of the protrusion is not particularly limited, and may be, for example, a spine shape (a state in which a sharp shape is formed by a straight line) or a sickle shape (a sharp shape is partially curved). It may be in a spherical shape (a state formed by tying a traction portion 250).

The operator is pulling the towing portion 250 by locking any of the locking portions 280 provided in the towing portion 250 to the hole portion 270 when the towing portion 250 is towed (hereinafter, referred to as a state). It can maintain a traction state). Therefore, the operator is in a state in which the fixed portion expands the outer shape by the locking portion 280 even when the traction portion 250 is not towed (while the operating portion 230 is not being operated) (hereinafter referred to as an expanded state). Can be maintained.

The material of the traction portion 250 is not particularly limited as long as the fixing portion 220 can be compressed in the axial direction X when the traction portion 250 is towed while being inserted through the lumen L.

When the traction portion 250 is made of a biodegradable material, the strength of the traction portion 250 decreases when the traction portion 250 is decomposed in a living body. Then, the traction force of the traction portion 250 with respect to the main body portion 210 is reduced (the traction state is released). The fixed portion 220 is changed from an expanded state (a state in which each of the beam portions 222 is bent outward in the radial direction) to a natural state (a state in which each of the beam portions 222 is not bent) due to the elastic force of the main body portion 210. Return to. Therefore, the fixing force of the medical device 200 to the pancreatic parenchyma B1 is weakened, and the medical device 200 can naturally fall into the jejunum B2.

Further, the constituent material of the traction portion 250 is not particularly limited, and for example, vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (Styrene-ethylene-propylene-styrene copolymer). It can be composed of a thermoplastic elastomer such as SEPS), a thermoplastic resin such as nylon or PET, or a rubber or silicone elastomer.

Further, the cross-sectional shape and thinness of the traction portion 250 are not particularly limited as long as they do not interfere with the anastomosis of the digestive tract.

Further, the traction portion 250 may have a needle portion having biocompatibility at the other end portion opposite to the one end portion fixed to the connection portion 260. Thereby, the operator can suture and fix the jejunum B2 on the serosa of the jejunum B2 at the traction portion 250 to bring the jejunum B2 and the pancreatic parenchyma B1 close to each other.

Further, the locking portion 280 may be provided on the hole portion 270 side. The hole 270 may be provided with, for example, a valve body or a notch. The locking portion 280 can maintain the traction state by sandwiching at least a part of the traction portion 250. When the locking portion 280 is a valve body provided on the hole portion 270 side, the traction portion 250 is elastically deformed when the operator applies a tension equal to or higher than a predetermined value to the traction portion 250. It can be configured to be able to move forward and backward. Further, when the locking portion 280 is a notch (slit) provided on the hole portion 270 side, the locking portion 280 is removed from the notch when the operator applies a tension equal to or higher than a predetermined value to the traction portion 250. The traction unit 250 can be configured to be able to move forward and backward.

The material of the locking portion 280 is not particularly limited as long as it has elasticity, but it is preferably composed of a biodegradable material. When the locking portion 280 is decomposed in the living body, the traction state is released. Therefore, the fixing force of the medical device 200 to the pancreatic parenchyma B1 is weakened, and the medical device 200 can naturally fall into the jejunum B2. When the locking portion 280 is made of a biodegradable material, the traction portion 250 may be made of a non-biodegradable material.

The constituent material of the locking portion 280 is not particularly limited, and for example, vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS). ) And the like, a thermoplastic resin such as nylon and PET, rubber, a silicone elastomer and the like.

Further, the shape of the locking portion 280 is not particularly limited as long as it can pass through the hole 270 of the main body 210 or be locked in the hole 270 by elastic deformation. Further, the shapes of the locking portions 280 may be the same as or different from each other.

Further, as described above, the medical device 200 according to the present embodiment has been described as having the main body 210, the fixing 220, the operating 230, and the auxiliary 240, but the main body 210 and the fixing 220 It may be configured by the operation unit 230. Further, the tow portion 250 does not have to be integrally formed with the main body portion 210. In this case, the surgeon prepares the traction portion 250 separately from the medical device 200 during the procedure. The surgeon can use the medical device 200 and the traction portion 250 in an appropriate combination according to the progress of the procedure and the like.

As described above, the medical device 200 according to the present embodiment is arranged between the pancreatic parenchyma B1 and the jejunum B2 (a pair of gastrointestinal tracts to be joined), and has a main body 210 (tubular member) having a lumen L and a main body portion 210 (tubular member). It has a fixing portion 220 that generates a fixing force for forming the main body portion 210 so as to be able to be fixed to the pancreatic parenchyma B1 (at least one gastrointestinal tract), and the fixing portion 220 has an outer shape (outer diameter r1) by an external force. ) Is extensible.

According to the medical device 200, the fixing portion 220 expands the inner wall of the pancreatic duct B1b by expanding the outer shape (outer diameter r1) of the medical device 200, and the fitting force (resistance) of the medical device 200 to the pancreatic parenchyma B1. Power) can be increased. Therefore, the fixing portion 220 can fix the main body portion 210 to the pancreatic duct B1b. Therefore, when the operator inserts the medical device 200 into the pancreatic duct B1b once and fixes the main body 210 to the pancreatic duct B1b by the fixing portion 220, the medical device 200 is inserted into the cavity of the pancreatic parenchyma B1 (pancreatic duct B1b). Can be maintained. Further, the surgeon moves the circumference of the cut surface B1a of the pancreatic parenchyma B1 (anterior wall B1d and posterior wall B1c) and the jejunum B2 without inserting and removing the medical device 200 from the pancreatic duct B1b, and moves the pancreatic parenchyma B1 and the jejunum. B2 can be joined. Therefore, the operator can perform anastomosis between the pancreatic parenchyma B1 and the jejunum B2 without suturing the pancreatic duct B1b and the jejunum B2, and can easily join the pancreatic parenchyma B1 and the jejunum B2.

Further, the medical device 200 includes an operation unit 230 that deforms the fixed portion 220 by transmitting an external force to the fixed portion 220. Therefore, the operator can easily join the pancreatic parenchyma B1 and the jejunum B2.

Further, the operation unit 230 is a connection that enables the connection between the traction unit 250 that applies an external force to the fixing unit 220 by being pulled and compresses the fixing unit 220 in the axial direction X and the traction unit 250 to the main body unit 210. A unit 260 is provided. Therefore, the operator can deform the fixed portion 220 without directly applying an external force to the fixed portion 220.

Further, the medical device 200 further includes an auxiliary unit 240 that maintains a state in which the operating unit 230 transmits an external force to the fixed unit 220. Therefore, the operator can maintain the expanded state of the medical device 200 even when the operation unit 230 is not operated.

Further, the auxiliary portion 240 is formed on the main body portion 210, and is formed on the base end side (one end side of the main body portion 210) from the fixed portion 220 formed on the tip end side (end portion in the axial direction X) of the main body portion 210. A hole 270 (insertion hole) that is arranged on the central side of the fixed portion 220 and exposes the traction portion 250 to the outside when the traction portion 250 is inserted into the lumen L, and at least one of the traction portion 250 and the hole portion 270. The locking portion 280 is provided in the above and is configured so that at least a part of the traction portion 250 can be locked in the hole portion 270. Therefore, when the traction portion 250 is towed, the operator maintains the traction state by locking any of the locking portions 280 provided on the traction portion 250 to the hole 270 of the main body portion 210. be able to. Therefore, the operator can maintain the expanded state of the medical device 200 by the locking portion 280.

Further, the fixing portion 220 includes a plurality of hole portions 221 provided on the tip end side (end portion in the axial direction X) of the main body portion 210, and a plurality of beam portions 222 arranged between each of the hole portions 221. When the fixed portion 220 is compressed in the axial direction X by the traction portion 250, the fixed portion 220 expands the outer diameter r1 by bending each of the beam portions 222 outward in the radial direction. By expanding the outer shape (outer diameter r1) of the medical device 200, the inner wall of the pancreatic duct B1b can be expanded to increase the fitting force (resistance) of the medical device 200 to the pancreatic parenchyma B1. Therefore, the fixing portion 220 can fix the main body portion 210 to the pancreatic duct B1b.

Further, the medical device set 1 has the above-mentioned medical device 200 and a fusion promoting sheet 100 that promotes fusion between the pancreatic parenchyma B1 and the jejunum B2 by being arranged between the pancreatic parenchyma B1 and the jejunum B2. With this configuration, it is possible to reduce the risk of postoperative suture failure in the procedure of joining a pair of gastrointestinal tracts, and it is easy to suppress the leakage of pancreatic juice from the pancreatic duct B1b during the procedure. The pancreatic parenchyma B1 and the jejunum B2 can be joined.

Next, modifications 1 to 3 of the medical device 200 according to the first embodiment will be described. In the description of the modified examples 1 to 3, the same reference numerals are given to the configurations common to the medical device 200 described above, and the description thereof will be omitted as appropriate. Further, the contents that are not particularly explained in the description of the modified example can be the same as those in the above-described embodiment.

<Modification example 1>
13 and 14 are views provided for explaining the medical device 300 according to the first modification.

The medical device 300 can fix the main body 210 to the gastrointestinal tract (pancreatic parenchyma B1 and jejunum B2) to be joined and to at least one gastrointestinal tract (pancreatic parenchyma B1). It has a fixing portion 320 that generates a fixing force for forming, and an operating portion 330 that deforms the fixing portion 320 by transmitting an external force to the fixing portion 320.

As shown in FIG. 13, the fixing portion 320 according to the first modification is partially housed in a plurality of holes 321 provided in a certain area on the tip end side of the main body portion 210 and inside the main body portion 210. It may be composed of a plurality of wires 322 that can protrude from each of the holes 321 when compressed in the axial direction X by an external force.

Further, the operation unit 330 according to the first modification is provided so as to project toward the base end side of the main body portion 210, and can be pushed toward the tip end side of the main body portion 210 on the base end side of the wire 322. It may be composed of.

The tip end side of the wire 322 according to the first modification is housed in a recess provided between the inner peripheral wall and the outer peripheral wall of the main body 210. Further, the base end side of the wire 322 is provided so as to project toward the base end side of the main body 210. Further, the recess communicates with the hole 321. Therefore, the wire 322 is inserted into the main body 210 so as to partially follow the hole 321.

When the operator operates the operation unit 330 (the wire 322 protruding toward the base end side of the main body 210 is pushed toward the tip end side), the wire 322 is compressed in the axial direction X and in the radial direction as shown in FIG. (Diameter) Bend outward. Then, the bent portion of the wire 322 protrudes from the hole portion 321. In this way, the operator can expand the outer shape (outer diameter) of the medical device 300 into a circular shape (radial) by applying an external force to the wire 322.

By adjusting the length of the hole 321 and the length of the wire 322, the surgeon changes the outer diameter of the fixed portion 320 after the diameter is expanded and the shape of the wire 322 after the wire 322 is deformed, and is a medical device for the digestive tract. The fixing force of 300 can be adjusted.

The wire 322 is preferably an alloy having elasto-plasticity or shape memory and having biodegradability, and can be composed of, for example, Mg or an alloy containing Mg as a main component. Since the wire 322 has elasto-plasticity or shape memory, it can maintain its shape after being deformed by an external force. Therefore, the medical device 300 can maintain the expanded state. Further, since the wire 322 has biodegradability, its strength decreases when it is decomposed in a living body. Therefore, the medical device 300 is released from the expanded state after a predetermined period of time has passed since it was placed in the living body, and can be naturally dropped into the jejunum B2.

<Modification 2>
15 and 16 are diagrams for explaining the medical device 400 according to the second modification.

The medical device 400 can fix the main body 210 to the gastrointestinal tract (pancreatic parenchyma B1 and jejunum B2) to be joined and to at least one gastrointestinal tract (pancreatic parenchyma B1). It has a fixing portion 420 that generates a fixing force for construction, and an operating portion 430 that deforms the fixing portion 420 by transmitting an external force to the fixing portion 420.

As shown in FIG. 15, the fixing portion 420 according to the modified example 2 is connected to the tip end side of the operation portion 430 and the main body portion 210, which will be described later, and is provided so as to spirally wind around the main body portion 210. It may be composed of a wire 421.

Further, the operation unit 430 according to the second modification may be provided by a grip portion provided on the base end side of the main body portion 210 and rotatably configured in the circumferential direction θ of the main body portion 210.

When the operator operates the operation unit 430 (rotates the wire 421 in the direction opposite to the winding direction), the winding diameter of the wire 421 increases as shown in FIG. Therefore, the operator can expand the outer shape (outer diameter) of the medical device 400 by applying an external force to the wire 421.

By adjusting the amount of operation of the operation unit 430, the operator can change the outer diameter of the fixing unit 420 after the expansion and adjust the fixing force of the medical device 400 to the digestive tract.

The wire 421 can be made of the same material as the wire 322 of the first modification.

Further, the cross-sectional shape of the wire 421 is not particularly limited. The wire 421 may be partially provided with protrusions, and the protrusions can further increase the fitting force (resistance force) to the pancreatic parenchyma B1.

The form of the connection portion between the operation unit 430 and the main body 210 is not particularly limited. For example, the operation unit 430 may be partially inserted into the lumen L of the main body unit 210. Further, the method of connecting the operation unit 430 and the main body 210 is not particularly limited, and for example, the main body 210 and the operation unit 430 can be connected by providing a protrusion or the like on the lumen L of the main body 210. The protrusion may be made of the same material as the main body 210, or may be made of a different material, but may be made of, for example, a biodegradable material or a water-soluble material. With this configuration, when the protrusion is decomposed in the living body, the lumen L of the main body 210 is expanded. Therefore, it is possible to further secure an excretion route for discharging pancreatic juice from the pancreatic duct B1b to the jejunum B2.

<Modification example 3>
17 and 18 are views provided for explaining the medical device 500 according to the third modification.

The medical device 500 can fix the main body 510 arranged between the digestive tracts (pancreatic parenchyma B1 and jejunum B2) to be joined and the main body 510 to at least one gastrointestinal tract (pancreatic parenchyma B1). It has a fixing portion 520 that generates a fixing force for construction, and an operating portion 530 that deforms the fixing portion 520 by transmitting an external force to the fixing portion 520.

The main body 510 according to the third modification is preferably an alloy having elasto-plasticity or shape memory and biodegradability, and is composed of, for example, Mg or an alloy containing Mg as a main component.

As shown in FIG. 17, the fixing portion 520 according to the modified example 3 is arranged between a plurality of hole portions 521 provided in a certain region on the tip end side of the main body portion 510 and each of the hole portions 521. It may be composed of a plurality of beam portions 522.

The operation unit 530 according to the modification 3 may be configured by using a certain area on the base end side of the main body unit 510 as a grip portion.

When the operator operates the operation portion 530 (twists the base end side of the main body portion 510), the fixing portion 520 is spirally deformed and the beam portion 522 is outside the radial direction (diameter direction) as shown in FIG. Bend in the direction. In this way, the operator can expand the outer shape (outer diameter) of the medical device 500 by applying an external force to the fixed portion 520.

By adjusting the length and inclination angle of the hole 321, the surgeon can change the outer diameter of the fixed portion 320 after expansion and the outer diameter when viewed from the axial direction X, and the surgeon can change the outer diameter of the medical device 200 for the digestive tract. The fixing force can be adjusted.

<Example of treatment method (living organ anastomosis)>
Next, a treatment method using a medical device set will be described.

FIG. 19 is a flowchart showing each procedure of the treatment method using the medical device set.

The treatment method is to place a medical instrument between one joint site to be joined and the other joint site to be joined (S11), and to have a sheet-shaped main body that promotes fusion of biological tissues. Inserting the promotion sheet through the medical device and fixing the medical device to one of the jointed parts (S12), at least a part of the main body of the fusion promoting sheet between one of the joined parts and the other of the joined parts. Includes joining (S13) between one joined portion and the other joined portion in a state where the above is arranged.

The living organ to be joined by the treatment method and the jointed part in the living organ are not particularly limited and can be arbitrarily selected. In the following description, pancreatic parenchymal-jejunal anastomosis will be described as an example. Further, as the medical device set used in each procedure described below, for example, any one can be selected from the above-mentioned medical device sets, and other medical device sets can be selected. You can also. However, in the following description, a usage example of the medical device set 1 shown in FIG. 1 will be described as a typical example that can be suitably used for each procedure. Further, in each procedure described below, detailed description of known procedure procedures and known medical devices / instruments will be omitted as appropriate.

Hereinafter, in the description of the present specification, "arranging a fusion promoting sheet (or medical device) between living organs" means that the healing promoting sheet (or medical device) comes into direct or indirect contact with the living organ. The fusion-promoting sheet (or medical device) is placed in a state, the fusion-promoting sheet (or medical device) is placed in a state where a spatial gap is formed between the living organs, or both. ) Is placed (for example, one biological organ is in contact with the fusion promoting sheet (or medical device), and the other biological organ is not in contact with the healing promoting sheet (or medical device). That means at least one of them. Further, in the description of the present specification, the term "periphery" does not define a strict range (region), but a predetermined range (region) as long as the purpose of treatment (bonding between biological organs) can be achieved. Means. In addition, the order of the procedure procedures described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. Further, in the description of the present specification, "relatively approaching" means both bringing two or more objects to be approached close to each other and bringing only one close to the other.

<Example of treatment method (pancreatic parenchyma-jejunal anastomosis)>
FIG. 20 is a flowchart showing the procedure of the embodiment of the treatment method (pancreatic parenchymal-jejunal anastomosis), and FIGS. 21 to 26 are diagrams used for explaining the pancreatic parenchymal-jejunal anastomosis.

In the treatment method according to the present embodiment, the biological organs to be joined are the pancreatic parenchyma B1 after pancreaticoduodenectomy and the jejunum B2. In the following description, a procedure for joining the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 (one joined site) and an arbitrary site of the intestinal wall of the jejunum B2 (the other joined site) will be described.

As shown in FIG. 20, the treatment method according to the present embodiment is to prepare a medical device set 1 having a fusion promoting sheet 100 and a medical device 200 (S101), and insert the medical device 200 into the pancreatic duct B1b. Arrangement (S102), attachment of the fusion promotion sheet 100 to the medical device 200 (S103), insertion of the medical device 200 into the jejunum B2 (S104), stitching of the pancreatic parenchyma B1 and the jejunum B2 (S105). ,including.

Next, an example of the treatment method according to the present embodiment will be specifically described with reference to FIGS. 21 to 26. In FIG. 26, a plurality of needles at both ends 920a to 920e, which will be described later, are omitted.

First, the surgeon prepares a medical device set 1 having a fusion promoting sheet 100 and a medical device 200 (S101).

Next, as shown in FIG. 21, the operator inserts the medical device 200 into the pancreatic duct B1b from the distal end side of the main body 210 (the distal end side opening 210A side shown in FIG. 1). The surgeon can then fix the medical device 200 to the pancreatic parenchyma B1 (S102). At this time, the operator can expand the outer shape (outer diameter r1) of the fixed portion 220 by pulling the towed portion 250 and compressing the fixed portion 220 in the axial direction X (see FIG. 22). .. Further, the operator can maintain the traction force of the traction portion 250 with respect to the main body portion 210 by locking the locking portion 280 formed in the traction portion 250 to the hole portion 270 of the main body portion 210. Therefore, the operator can fix the position of the medical device 200 with respect to the pancreatic duct B1b by the fixing portion 220.

Next, as shown in FIG. 23, the operator forms a hole 120 (see FIG. 1) in the fusion promoting sheet 100 and attaches it to the medical device 200 (S103). The device used by the operator when forming the hole 120 is not particularly limited. Further, the hole 120 may be formed in the fusion promoting sheet 100 in advance in a state before use. Further, the surgeon may insert the medical device 200 into the pancreatic duct B1b after inserting the medical device 200 into the hole 120 of the fusion promoting sheet 100.

Next, the operator inserts the proximal end side of the main body 210 (the proximal end side opening 210B side shown in FIG. 1) into the jejunum B2 (S104). As a result, a drainage route for draining pancreatic juice from the pancreatic duct B1b to the jejunum B2 is formed (see FIG. 26), and the pancreatic juice from the pancreatic duct B1b is suppressed from leaking to the junction between the pancreatic parenchyma B1 and the jejunum B2. Can be done.

Next, as shown in FIG. 24, the operator places the fusion promoting sheet 100 on the cut surface B1a of the pancreatic parenchyma B1 and sutures the pancreatic parenchyma B1 and the jejunum B2 (S105). In the following description, an example of a procedure for fixing the fusion promoting sheet 100 to the pancreatic parenchyma B1 by using a plurality of both end needles 920a to 920e as fixing members will be described. As the needles at both ends 920a to 920e, known needles having a bioabsorbable absorbent thread (suture) and a biocompatible needle portion attached to both ends of the absorbent thread can be used.

First, the surgeon performs the anterior wall B1d of the pancreatic parenchyma B1 from the posterior wall B1c of the pancreatic parenchyma B1 (the dorsal portion of the pancreatic parenchyma B1 in the circumferential direction) and the portion arranged on the posterior wall B1c in the fusion promoting sheet 100. Both ends needles 920a are moved toward (the ventral portion in the circumferential direction of the pancreatic parenchyma B1) and the portion arranged on the anterior wall B1d in the fusion promoting sheet 100.

Next, the surgeon moves the needles 920a at both ends so as to insert the serosal muscular layer of the jejunum at the planned anastomosis site of the jejunum B2 (around the through hole B2a formed in the jejunum B2). The operator repeats such an operation to insert a plurality of double-ended needles 920a to 920e into the jejunal serosal muscular layer of the fusion promoting sheet 100, the pancreatic parenchyma B1 and the jejunum B2. In this way, the operator can fix the fusion promoting sheet 100 to the pancreatic parenchyma B1 by using a plurality of both end needles 920a to 920e that suture the pancreatic parenchyma B1 and the jejunum B2.

The number of both-end needles to be inserted into the jejunal serosal muscular layer of the pancreatic parenchyma B1 and the jejunum B2 and the position to insert the both-end needles are not particularly limited. Further, the surgeon may fix the fusion promoting sheet 100 to the pancreatic parenchyma B1 using biodegradable staples or the like as a fixing member instead of the plurality of double-ended needles 920a to 920e.

Next, as shown in FIG. 25, the operator ligates the needles 920a to 920e at both ends while pressing the jejunum B2 against the pancreatic parenchyma B1 with the operator's finger. As a result, the pancreatic parenchyma B1 and the jejunum B2 are sutured with the fusion promoting sheet 100 sandwiched therein (see FIG. 26). The jejunum B2 is deformed by the tension generated during suturing so as to wrap around the cut surface B1a of the pancreatic parenchyma B1 and the main body 110 of the fusion promoting sheet 100.

By the above operation, the operator can place the main body 110 of the fusion promoting sheet 100 between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. In addition, the surgeon can place the medical device 200 as a so-called internal fistula tube between the pancreatic parenchyma B1 and the jejunum B2. The main body 110 of the fusion promoting sheet 100 is placed between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 while being in contact with the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. This promotes the fusion of the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2. In addition, the medical device 200 naturally falls off into the jejunum B2 after a predetermined period (several weeks to several months) has elapsed since the operator anastomosed the biological organ, and is led out of the body.

As described above, the treatment method according to the present embodiment is applied to the procedure for joining the pancreatic parenchyma B1 and the jejunum B2. Further, in the above-mentioned treatment method, the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 and the intestinal wall (jejunal serosal muscular layer) of the jejunum B2 are joined. According to this treatment method, the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2 are formed by the main body 110 of the fusion promoting sheet 100 sandwiched between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. Can promote fusion and reduce the risk of suture failure after pancreatic parenchymal-jejunostomy.

The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. For example, although the fusion promotion sheet and the medical device have been described above as separate bodies, they may be integrated.

Further, in the above, the embodiment of the medical device in which the fixed portion is arranged on one side in the axial direction X of the main body portion has been described. However, as shown in FIG. 27, the fixing portions 220 may be arranged on both sides of the main body portion 210 in the axial direction X, as long as the fixing portions are easily locked in the living lumen in which the medical device is arranged. By providing the fixing portions 220 on both sides of the medical device 200A in this way, it can be expected that the fixing force of the medical device to the biological organ will increase (see FIG. 28). In addition, each of the traction portions 250 for traction of the fixing portions 220 arranged on both sides of the main body portion 210 may be connected to each other. As a result, the operator can operate the fixing portions 220 arranged on both sides of the main body portion 210 at once.

Further, although the embodiment of the medical device in which one fixing portion is provided on one side in the axial direction X of the main body portion has been described above, a plurality of fixing portions may be provided on one end side of the medical device. In this case, the distance between one fixed portion and the other fixed portion is the height of the beam portion extending radially from the outer peripheral surface of the main body portion when the medical device is in the expanded state (t1 shown in FIG. 4). It is preferable that it is narrower. As a result, it is possible to suppress the possibility that each of the fixed portions repels the inner wall of the digestive tract and falls inward in the radial direction. Therefore, according to the fixing portion arranged in this way, it is possible to prevent the fixing force of the medical device from the gastrointestinal tract from being reduced during the procedure.

Further, when a plurality of fixing portions are provided on one end side of the medical device, the main body portion is orthogonal to the axial direction X with each of the fixing portions as a starting point when an external force is applied by the traction portion. It may bend in a W shape when viewed from the direction in which it is used. According to the fixing portion arranged in this way, the outer shape of the medical device can be expanded, and it can be expected that the fixing force of the medical device to the digestive tract is further secured.

Further, when a plurality of fixing portions are provided on one end side of the medical device, a tubular member (hereinafter referred to as an internal tube) may be further provided on the lumen of the main body portion. The internal tube prevents the main body from bending in a W shape when viewed from the direction orthogonal to the axial direction X with each of the fixed parts as the starting point when an external force is applied by the traction part, and the pancreatic juice of the main body It can make it easier to pass through the lumen. Further, the internal tube can assist the fixing portion so that the external force is uniformly transmitted to the plurality of beam portions when the external force is applied by the traction portion. Therefore, the internal tube can uniformly expand the fixing portion to maintain the fixing force of the medical device.

The outer diameter of the inner tube is not particularly limited as long as it is smaller than the inner diameter of the main body. Further, the constituent material of the inner tube is not particularly limited as long as it can be composed of a material harder than the main body portion or the fixed portion. The length of the inner tube with respect to the axial direction X is not particularly limited, but the end portion of the inner tube on the tip end side is on the tip end side of one fixing portion (fixed portion on the tip end side) arranged on the tip end side of the main body portion. It is preferable that the base end side end portion of the inner tube is arranged on the base end side of the other fixing portion (terminal side fixing portion) arranged on the base end side of one fixed portion. Therefore, the inner tube preferably extends from the connecting portion to the hole portion, and more preferably extends from the connecting portion to the fixing portion on the terminal side. The method and position of connecting the internal tube to the main body are not particularly limited, but the internal tube may be connected to the main body at the connecting portion. When the inner tube is not connected to the main body, the inner surface of the main body and the outer surface of the inner tube may be coated with a lubricant such as silicone oil. In this case, the lubricity of the inner tube with respect to the main body is improved, and the inner tube can move the lumen of the main body more smoothly. Therefore, the force required when the operator pulls the traction portion can be reduced. The material that imparts slipperiness to the inner surface of the main body and the outer surface of the inner tube is not limited to the above-mentioned lubricating coating, and can be formed by combining materials having a small coefficient of friction.

Further, in the above, the embodiment in which the main body portion is arranged so as to function as an internal fistula tube has been described. However, the body may be arranged to function as an external fistula tube. In this case, the main body is arranged from the inside of the body to the outside of the body so as to penetrate the pancreatic parenchyma, the jejunum and the skin. Then, the pancreatic juice can be drained to the outside of the body by connecting the end portion of the main body toward the outside of the body to the drainage bag. The main body is pulled out of the body by the operator pulling the main body after a predetermined period of time has elapsed.

This application is based on Japanese Patent Application No. 2020-60482 filed on March 30, 2020, the disclosure of which is cited as a whole by reference.

1 Medical equipment set,
100 fusion promotion sheet,
200 medical devices,
210 Main body (tubular member),
220 fixed part,
221 hole,
222 Beam,
230 operation unit,
240 Auxiliary part,
250 tow part,
260 connections,
270 hole (insertion hole),
280 locking part.

Claims

A tubular member located between a pair of gastrointestinal tracts to be joined and having lumens,
It has a fixing portion that generates a fixing force for forming the tubular member so that it can be fixed to at least one gastrointestinal tract.
The fixed portion is a medical device whose outer shape can be expanded by an external force.
The medical device according to claim 1, further comprising an operation unit that deforms the fixed portion by transmitting the external force to the fixed portion.
The operating portion includes a traction portion that applies an external force to the fixed portion by being pulled and compresses the fixed portion in the axial direction.
The medical device according to claim 2, further comprising a connection portion that enables connection of the traction portion to the tubular member.
The medical device according to claim 3, further comprising an auxiliary unit for maintaining a state in which the operating unit transmits the external force to the fixed unit.
The auxiliary portion is formed on the tubular member, is arranged on the center side of the fixed portion formed at the axial end portion of the tubular member, and is the traction portion in a state where the traction portion is inserted into the lumen. With an insertion hole that exposes to the outside,
The medical device according to claim 4, further comprising a locking portion provided on at least one of the traction portion and the insertion hole so that at least a part of the traction portion can be locked in the insertion hole.
The fixing portion has a plurality of holes provided at the axial ends of the tubular member and a plurality of beam portions respectively arranged between the holes.
According to any one of claims 3 to 5, when the fixed portion is compressed in the axial direction by the traction portion, each of the beam portions is bent outward in the radial direction to expand the outer shape. The medical device described.
The medical device according to any one of claims 1 to 6 and
A medical device set comprising a fusion promoting sheet that promotes fusion of the pair of digestive tracts by being arranged between the pair of digestive tracts.