Medical instruments and medical instrument sets

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

[Technical field]

[0001] The present invention relates to medical instruments and medical instrument sets. [Background technology]

[0002] As one of the techniques for surgically joining a pair of living organs (e.g., digestive tract anastomosis), a technique for joining the pancreatic parenchyma and the jejunum is known. As one of the treatment methods for tumors near the head of the pancreas, a pancreaticoduodenectomy is known in which the head of the pancreas and its surrounding tissues are removed. After pancreaticoduodenectomy, a technique for joining the pancreatic parenchyma and the jejunum is performed.

[0003] In a procedure for joining the pancreatic parenchyma and the jejunum, the pancreatic parenchyma and the jejunum are sutured together with a suture member such as a biodegradable suture. In a procedure for joining the pancreatic parenchyma and the jejunum, a pancreatic duct tube (see, for example, Patent Document 1 below) may be used to prevent leakage of pancreatic juice discharged from the pancreatic duct to the junction where the pancreatic parenchyma and the jejunum are joined. The pancreatic duct tube is placed in the living body with one end inserted into the pancreatic duct and the other end led out of the body via the inside of the jejunum, etc. The placed pancreatic duct tube prevents leakage of pancreatic juice discharged from the pancreatic duct to the junction by discharging it out of the body. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2007-167540 A Summary of the Invention [Problem to be solved by the invention]

[0005] The present inventors have been making intensive studies on a medical device that can simply and easily join a pair of digestive tracts, such as the jejunum and pancreatic parenchyma.

[0006] SUMMARY OF THE PRESENT EMBODIMENTS Accordingly, an object of the present invention is to provide a medical device that can easily join a pair of digestive tracts. [Means for solving the problem]

[0007] The medical device according to the present invention, which achieves the above object, is disposed between a pair of digestive tracts to be joined, and includes a tubular member having a lumen, and a fixing force for fixing the tubular member to at least one of the digestive tracts. , the external shape can be expanded by external force A fixed portion; an operating unit that transmits the external force to the fixed portion to thereby deform the fixed portion; and an auxiliary unit that maintains a state in which the operating unit transmits the external force to the fixed portion; Have The operating section includes a traction section that applies the external force to the fixed section by being pulled, compressing the fixed section in the axial direction, and a connection section that enables connection of the traction section to the tubular member. The auxiliary section is formed on the tubular member, is positioned closer to the center than the fixed section formed at the end of the tubular member in the axial direction, and includes an insertion hole that exposes the traction section to the outside when the traction section is inserted into the lumen. Effect of the Invention

[0008] Since the medical instrument and medical instrument set according to the present invention are configured as described above, a pair of digestive tracts can be easily joined together. [Brief description of the drawings]

[0009] [Figure 1] FIG. 1 shows a medical instrument set according to an embodiment of the present invention. [Diagram 2] FIG. 11 is an enlarged cross-sectional view showing a through-hole of a healing-promoting sheet constituting the medical instrument set. [Diagram 3] 2 is a side view showing a fixing portion of the medical device shown in FIG. 1. FIG. [Figure 4] 2 is a side view showing an expanded state of a fixing part of the medical device in FIG. 1. FIG. [Diagram 5] FIG. 5 is an enlarged cross-sectional view taken along line 5-5 in FIG. 4. [Figure 6] 13A and 13B are schematic diagrams showing modified examples of holes that form the fixing portion. [Figure 7] 7 is a cross-sectional view showing an expanded state of a fixing part of the medical device in FIG. 6. FIG. [Figure 8] 13A and 13B are schematic diagrams showing modified examples of holes that form the fixing portion. [Figure 9] 13A and 13B are schematic diagrams showing modified examples of holes that form the fixing portion. [Figure 10] 10 is a cross-sectional view showing an expanded state of a fixing part of the medical device in FIG. 9. FIG. [Figure 11] 13A and 13B are schematic diagrams showing modified examples of holes that form the fixing portion. [Figure 12] 12 is a side view showing an expanded state of a fixing part of the medical device in FIG. 11. FIG. [Figure 13] 1. FIG. 4 is a schematic diagram showing a first modified example of the medical device in FIG. [Figure 14] 14 is a side view showing an expanded state of a fixing part of the medical device in FIG. 13. FIG. [Figure 15] 1. FIG. 4 is a schematic diagram showing a second modified example of the medical device in FIG. [Figure 16] 16 is a schematic diagram showing an expanded state of a fixing part of the medical device in FIG. 15. FIG. [Figure 17] 1. FIG. 4 is a schematic diagram showing a third modified example of the medical device in FIG. [Figure 18] 18 is a side view showing an expanded state of a fixing part of the medical device in FIG. 17. FIG. [Figure 19] 1 is a flowchart showing each step of a treatment method using a medical device. [Figure 20] 1 is a flow chart showing the steps of an embodiment of a treatment method (pancreaticojejunostomy). [Figure 21] FIG. 1 is a schematic cross-sectional view for explaining pancreaticojejunal anastomosis. [Figure 22] FIG. 1 is a schematic cross-sectional view for explaining pancreaticojejunal anastomosis. [Diagram 23] FIG. 1 is a schematic cross-sectional view for explaining pancreaticojejunal anastomosis. [Figure 24] FIG. 1 is a schematic perspective view for explaining pancreaticojejunal anastomosis. [Diagram 25] FIG. 1 is a schematic perspective view for explaining pancreaticojejunal anastomosis. [Figure 26] FIG. 1 is a schematic cross-sectional view for explaining pancreaticojejunal anastomosis. [Figure 27] FIG. 13 is a diagram showing a medical instrument set in which fixing parts are formed on both ends of the medical instrument. [Figure 28]FIG. 28 is a schematic cross-sectional view illustrating pancreaticojejunostomy using the medical instrument set shown in FIG. 27. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Hereinafter, an embodiment of the present invention will be described with reference to the attached drawings. Note that the following description does not limit the technical scope or meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios.

[0011] First Embodiment <Medical Instrument Set 1> FIG. 1 is a diagram illustrating a medical instrument set 1 according to an embodiment of the present invention.

[0012] 21 to 26, the medical instrument set 1 can be applied to a procedure for joining predetermined biological organs together (for example, digestive tract anastomosis). As will be described later, in the description of this specification, pancreatic-jejunal anastomosis for joining pancreatic parenchyma B1 and jejunum B2 will be described as an example of a procedure using the medical instrument set 1.

[0013] The medical instrument set 1 includes a healing-promoting sheet 100 and a medical instrument 200 .

[0014] <Healing Promotion Sheet 100> FIG. 2 is an enlarged cross-sectional view showing a through-hole 112 of a healing-promoting sheet 100 constituting the medical instrument set 1. As shown in FIG.

[0015] As shown in FIG. 1, the healing promoting sheet 100 is formed from a biodegradable sheet having a plurality of through-holes 112 and has a main body portion 110 that promotes healing of biological tissue.

[0016] As shown in FIGS. 1 and 2, the main body 110 is made of a sheet-like member.

[0017] 1 and 2, the through holes 112 formed in the main body 110 are provided regularly and periodically in the surface direction of the main body 110. However, the through holes 112 may be provided randomly in each portion of the main body 110 in the surface direction.

[0018] 2, each through hole 112 extends approximately vertically between the front surface 111 and the back surface 113 along the thickness direction of the main body 110 (the 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.

[0019] 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 plan). 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.). Furthermore, each through hole 112 may have a different planar shape or cross-sectional shape.

[0020] 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.). Furthermore, the planar shape or cross-sectional shape of each through-hole 112 may be different.

[0021] The thickness of the main body part 110 (dimension T shown in FIG. 2) is not particularly limited, but is preferably 0.05 mm to 0.3 mm, and more preferably 0.1 to 0.2 mm. When the thickness of the main body part 110 is 0.05 mm or more (particularly when it is 0.1 mm or more), the main body part 110 can be provided with a strength sufficient to prevent the main body part 110 from being damaged when the healing-promoting sheet 100 is handled. On the other hand, when the thickness of the main body part 110 is 0.3 mm or less (particularly when it is 0.2 mm or less), the main body part 110 can be provided with sufficient flexibility to adhere closely to the biological tissue to which the main body part 110 is applied and to follow the biological tissue.

[0022] In main body 110, it is preferable that the ratio of hole diameter D of through hole 112 to pitch P of through holes 112 (the distance between adjacent through holes 112 as shown in FIG. 2) is 0.25 or more and less than 40. When through hole 112 has a perfect circle in plan view, hole diameter D of through hole 112 is equal to the diameter of the perfect circle. On the other hand, when through hole 112 does not have a perfect circle in plan view, hole diameter D of through hole 112 can be set to the diameter (circle-equivalent diameter) of a perfect circle having the same area as the area of ​​the opening of through hole 112 (the portion of through hole 112 facing front surface 111 or back surface 113).

[0023] 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 this embodiment, when calculating the value of the above-mentioned ratio, the arithmetic average value of two or more values ​​of the hole diameter D corresponding to each of the plurality of through holes 112 is used as a representative value of the hole diameter D. Meanwhile, the pitch P of the plurality of through holes 112 is defined as the shortest distance between the openings of two through holes 112. However, there are also a plurality of values ​​of the pitch P corresponding to combinations of adjacent through holes 112. Therefore, in this embodiment, when calculating the value of the above-mentioned ratio, the arithmetic average value of two or more values ​​of the pitch P corresponding to each combination of adjacent through holes 112 is used as a representative value of the pitch P.

[0024] The pitch P, hole diameter D, and ratio of hole diameter D to pitch P of the through holes 112 described above are merely examples and are not limited to these.

[0025] The main body 110 can be made of a biodegradable material. There is no particular limitation on the material of the main body 110, and examples of the material include biodegradable resins. Examples of biodegradable resins that can be used include known biodegradable (co)polymers such as those described in JP-T-2011-528275, JP-T-2008-514719, International Publication No. 2008-1952, and JP-T-2004-509205. Specific examples of the biodegradable resin include: (1) a polymer selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphate esters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose; and (2) copolymers composed of one or more monomers that constitute the above (1). That is, it is preferable that the biodegradable sheet contains at least one biodegradable resin selected from the group consisting of polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose, as well as copolymers composed of one or more monomers that constitute the above-mentioned polymers.

[0026] The method for producing the main body 110 is not particularly limited, but may be, for example, a method of producing fibers made of the above-mentioned biodegradable resin and using the fibers to produce a mesh-shaped sheet. The method for producing fibers made of biodegradable resin is not particularly limited, but may be, for example, an electrospinning method (electric field spinning method / electrostatic spinning method) or a melt-blowing method. The main body 110 may be produced by selecting only one of the above methods, or by selecting two or more of them in appropriate combination. As another example of the method for producing the main body 110, the biodegradable sheet member according to the present invention may be produced by spinning fibers made of the above-mentioned biodegradable resin according to a conventional method and weaving the obtained fibers into a mesh shape.

[0027] The main body 110 induces a biological reaction by the constituent material of the biodegradable resin that constitutes the main body 110. Through this action, the main body 110 induces the expression of biological components such as fibrin. The biological components induced in this manner can be accumulated so as to penetrate the through-holes 112 of the main body 110, thereby promoting fusion. Therefore, by placing the main body 110 between the pancreatic parenchyma B1 and the jejunum B2, promotion of fusion by the above-mentioned mechanism can occur.

[0028] The material of the fusion promoting sheet 100 does not have to be biodegradable as long as it can promote fusion of biological organs. Moreover, the fusion promoting sheet 100 does not have to have the through-holes 112 formed therein, regardless of the material, as long as it can promote fusion of biological organs.

[0029] <Medical Equipment 200> Next, the medical device 200 will be described. The medical device 200 is used to maintain communication between the lumens of a pair of digestive tracts to be joined, such as the pancreatic parenchyma B1 and the jejunum B2. Figures 3 to 12 are diagrams for explaining the medical device 200.

[0030] In the following description, one end of the medical device 200 that can be inserted into the jejunum B2 is referred to as the "base end," and the other end of the medical device 200 that can be inserted into the pancreatic parenchyma B1 is referred to as the "tip side." Also, the direction from the tip side toward the base side (or the opposite direction) is referred to as the axial direction X.

[0031] The medical device 200 has a main body portion 210 (corresponding to a "tubular member") that is placed between the digestive tracts to be joined (pancreatic parenchyma B1 and jejunum B2), a fixing portion 220 that generates a fixing force to configure the main body portion 210 so as to be fixable to at least one of the digestive tracts (pancreatic parenchyma B1), an operating portion 230 that deforms the fixing portion 220 by transmitting an external force to the fixing portion 220, and an auxiliary portion 240 that maintains the state in which the operating portion 230 is transmitting the external force to the fixing portion 220.

[0032] <Main body portion 210> The main body 210 includes a lumen L. In this embodiment, the hollow cross section is configured to have 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 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).

[0033] When the main body portion 210 is disposed between the pancreatic parenchyma B1 and the jejunum B2, it introduces pancreatic juice from the distal opening 210A into the lumen L and drains the pancreatic juice from the proximal opening 210B into the jejunum B2.

[0034] The main body 210 can be made of a non-biodegradable material having elasticity. After a predetermined period of time (several weeks to several months) has elapsed since the surgeon anastomoses the digestive tract and places the main body 210 in the living body, the main body 210 naturally falls off into the jejunum B2 and is led out of the body. That is, the main body 210 functions as a so-called internal fistula tube.

[0035] 1 and 3, the main body 210 has at least one side hole 210P on the tip side. When the side hole 210P is disposed between the pancreatic parenchyma B1 and the jejunum B2, it introduces pancreatic juice into the lumen L and drains it into the jejunum B2. Therefore, the side hole 210P can drain the pancreatic juice into the jejunum B2 even if the tip side opening 210A is blocked.

[0036] There are no particular limitations on the material of which the main body 210 is made, and it may be made of, for example, thermoplastic elastomers such as polyvinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), or other thermoplastic resins such as nylon or PET, or rubber, silicone elastomer, or the like.

[0037] <Fixed part 220> As shown in Figures 3 and 4, the fixing portion 220 is composed of a plurality of holes 221 provided in a certain region on the tip side of the main body portion 210, and a plurality of beam portions 222 each arranged between each of the holes 221.

[0038] 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 radially outward, thereby causing the outer shape (outer diameter r1) of the medical device 200 to expand in a circular shape (radially) (see FIG. 5).

[0039] As shown in FIGS. 4, 5, 7 and 10, each of the holes 221 is bent outward in a radial direction to expose an exposed surface 221m.

[0040] The fixing part 220 can expand the inner wall of the pancreatic duct B1b by expanding the outer diameter r1 of the medical device 200, thereby increasing the fitting force (resistance force) of the medical device 200 to the pancreatic parenchyma B1. Therefore, the fixing part 220 can fix the main body part 210 to the pancreatic duct B1b.

[0041] Once the surgeon inserts the medical device 200 into the pancreatic duct B1b and fixes the main body part 210 to the pancreatic duct B1b by the fixing part 220, the surgeon can maintain the state in which the medical device 200 is inserted into the lumen (pancreatic duct B1b) of the pancreatic parenchyma B1. Furthermore, the surgeon can join the pancreatic parenchyma B1 and the jejunum B2 by moving the needle around the cut surface B1a of the pancreatic parenchyma B1 (the front wall B1d and the rear wall B1c) and the jejunum B2 without inserting or removing the medical device 200 from the pancreatic duct B1b. Therefore, the surgeon 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.

[0042] 5, eight holes 221 and eight beams 222 are provided. Each of the holes 221 (and each of the beams 222) is provided at a predetermined interval in the circumferential direction θ of the fixed part 220. The number of holes 221 and beams 222 is not particularly limited, and is preferably 2 to 16, and more preferably 4 to 8.

[0043] The holes 221 are linear slits formed in the main body 210. The length k of each of the holes 221 along the longitudinal direction is the same or approximately the same as shown in Fig. 3, and is preferably 3 to 8 mm. The method for creating the holes 221 is not particularly limited, but for example, they can be created by laser processing.

[0044] 3, the hole 221 is formed to intersect with the axial direction X. The inclination angle θ1 of the hole 221 with respect to the axial direction X (the inclination angle of a virtual line m1 from a starting point 221a to an end point 221b of the hole 221 with respect to the axial direction X) is preferably 0 to 89°, and more preferably 17 to 45°.

[0045] Furthermore, the outer diameter r2 (see FIG. 4) of the fixed part 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 part 220 after expansion is preferably 4 to 8 mm, and more preferably 5 mm.

[0046] By adjusting the length k and the inclination angle θ1 of the hole 221, the surgeon can change the outer diameter r2 of the fixing portion 220 after expansion, and adjust the fixing force (hereinafter referred to as the fixing force of the medical device 200) for fixing the main body portion 210 to the digestive tract.

[0047] The fixing force after expansion of the medical device 200 is preferably 1.1 to 4 times that before expansion. The fixing force is the maximum strength when the base end side of the medical device 200 is grasped with forceps or the like and pulled at a constant speed after the medical device 200 is inserted into the pancreatic parenchyma B1 and the outer diameter r1 of the medical device 200 is expanded by the fixing part 220. If the fixing force before expansion is 1.2 to 1.7 N, the fixing force after expansion is preferably 2 to 5 N.

[0048] Also, although the hole 221 has been described as being linear, the shape of the hole 221 is not particularly limited. The hole 221 may be curved, for example, like an elliptical arc (see FIG. 6). By making the shape of the hole 221 curved, such as an elliptical arc, it is possible to adjust the shape of the beam portion 222 as viewed from the axial direction X when the fixing portion 220 is compressed in the axial direction X by an external force (see FIGS. 5 and 7). Therefore, the surgeon can adjust the amount of contact (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.

[0049] Furthermore, the hole 221 may be in the shape of a broken line formed by combining a plurality of straight lines (see FIG. 8). It is preferable that the angle (inclination angle θ2) of the starting point 221a of the hole 221 with respect to the imaginary line m1 is larger than the angle (inclination angle θ3) of the ending point 221b of the hole 221 with respect to the imaginary line m1. In this case, when the beam 222 is compressed in the axial direction X by an external force, it is bent with an inclination toward the base end side when viewed from a direction perpendicular to the axial direction X. Therefore, it is expected that the fixing portion 220 will generate a stronger fixing force of the medical device 200 to the digestive tract.

[0050] Additionally, the hole 221 may be spiral.

[0051] Furthermore, the direction in which the holes 221 extend is not particularly limited.

[0052] Further, there is no particular limitation on the arrangement of the holes 221. As shown in Fig. 4, the start points 221a (or end points 221b) of the holes 221 may be arranged in the circumferential direction θ of the main body part 210 (at the same position in the axial direction X of the main body part 210), or may be arranged in a zigzag pattern (at different positions from each other in the axial direction X of the main body part 210) as shown in Fig. 9.

[0053] As shown in FIG. 9, when each of the holes 221 is disposed at a different position from the other in the axial direction X of the main body portion 210, when the fixing portion 220 is compressed in the axial direction X by an external force, the external shape of the medical device 200 can be expanded to an approximately rectangular shape as shown in FIG. 10.

[0054] 11, one or more holes 223 shorter than the hole 221 may be formed on the base end side of the beam 222. The base end side of the beam 222 has more flexibility than the tip side where the hole 223 is not formed due to the hole 223 formed thereon. Therefore, when the beam 222 is compressed in the axial direction X by an external force, the beam 222 is bent with an inclination toward the base end side from the position where the hole 221 is formed (between the imaginary line m2 indicating the position of the starting point 221a of the hole 221 in the axial direction X to the imaginary line m3 indicating the end point 221b) as viewed from a direction perpendicular to the axial direction X (see FIG. 12). Therefore, the fixing portion 220 is expected to generate a stronger fixing force of the medical device 200 to the digestive tract.

[0055] <Operation section 230, auxiliary section 240> 1, 3, and 4, the operation unit 230 has a towing unit 250 that applies an external force to the fixed unit 220 by being towed, and a connection unit 260 that enables connection of the towing unit 250 to the main body unit 210. Also, the auxiliary unit 240 has a hole unit 270 (corresponding to an "insertion hole") that exposes the towing unit 250, which is at least partially inserted into the lumen L of the main body unit 210 starting from the connection unit 260, to the outside, and a locking unit 280 that is configured to be able to lock at least a part of the towing unit 250 to the hole unit 270, as shown in FIG.

[0056] The traction part 250 can be configured with an elongated member (for example, a thin-diameter string-like member or a band-like member having a predetermined width) having a predetermined length and a cross-sectional shape that can be inserted into the lumen L or the hole 270 of the main body part 210. There is no particular limit to the length of the traction part 250.

[0057] The connection part 260 is formed at the tip of the main body part 210. The method for fixing the base end of the traction part 250 to the tip side of the main body part 210 is not particularly limited, but it is possible to fix it by suturing or adhesive, to connect it by fusion or the like, or to tie one end of the traction part 250 into a loop and hook it onto the tip of the main body part 210.

[0058] The hole 270 is formed in the main body 210 and is disposed on the base end side of the fixing part 220 formed at the tip (on the central side of the fixing part 220 formed at one end side of the main body 210). The towing part 250 in this embodiment is inserted through the lumen L of the main body 210 from the connection part 260 formed at the tip of the main body 210 to the hole 270 formed at the base end side of the main body 210, and can apply an external force to the fixing part 220 by being towed. Therefore, the surgeon can deform the fixing part 220 without directly applying an external force to the fixing part 220. In addition, since the hole 270 is provided on the side surface of the main body 210, the surgeon can adjust the position at which the towing part 250 is towed in accordance with the procedure.

[0059] With at least a portion of the towing portion 250 inserted into the lumen L of the main body portion 210, the surgeon can apply an external force to the fixing portion 220 and compress the fixing portion 220 in the axial direction X by towing the towing portion 250 (applying axial tension to the towing portion 250).

[0060] 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 level or more is applied to the traction portion 250, it is elastically deformed to pass through (go over) the hole portion 270 and be locked in the hole portion 270. The shape (cross-sectional shape) of the protrusion is not particularly limited, and may be, for example, a thorn-like shape (a state in which a sharp shape is formed by straight lines), a sickle-like shape (a state in which a sharp shape is partially formed by curves), or a spherical shape (a state in which the traction portion 250 is formed by tying a knot).

[0061] When the surgeon pulls the towing section 250, the surgeon can maintain a state in which the towing section 250 is being pulled (hereinafter referred to as a pulling state) by engaging any one of the locking sections 280 provided on the towing section 250 with the hole section 270. Therefore, even when the surgeon is not pulling the towing section 250 (while the surgeon is not operating the operation section 230), the surgeon can maintain a state in which the fixing section expands its outer shape (hereinafter referred to as an expanded state) by the locking section 280.

[0062] The material of the towing part 250 is not particularly limited as long as it is capable of compressing the fixing part 220 in the axial direction X when the towing part 250 is towed in a state where it is inserted into the lumen L.

[0063] When the traction part 250 is made of a biodegradable material, the strength of the traction part 250 decreases when the traction part 250 decomposes in the living body. Then, the traction force of the traction part 250 on the main body part 210 decreases (the traction state is released). Then, the fixing part 220 returns from the expanded state (a state in which each of the beam parts 222 is bent radially outward) to the natural state (a state in which each of the beam parts 222 is not bent) by the elastic force of the main body part 210. Therefore, the fixing force of the medical device 200 on the pancreatic parenchyma B1 is weakened, and the medical device 200 can naturally fall into the jejunum B2.

[0064] In addition, there are no particular limitations on the material of which the traction portion 250 is made, and it may be made of, for example, thermoplastic elastomers such as polyvinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), or other thermoplastic resins such as nylon or PET, or rubber, silicone elastomer, or the like.

[0065] Furthermore, there are no particular limitations on the cross-sectional shape and thinness of the traction portion 250, so long as they do not impede the anastomosis of the digestive tract.

[0066] The traction portion 250 may have a needle portion having biocompatibility at the other end opposite to the one end fixed to the connection portion 260. This allows the surgeon to suture and fix the traction portion 250 on the serous membrane of the jejunum B2, thereby bringing the jejunum B2 and the pancreatic parenchyma B1 closer to each other.

[0067] The locking portion 280 may be provided on the hole 270 side. For example, a valve or a notch may be provided on the hole 270. The locking portion 280 can hold at least a part of the towing portion 250 in a towing state. When the locking portion 280 is a valve provided on the hole 270 side, the locking portion 280 can be elastically deformed when the surgeon applies a tension of a predetermined level or more to the towing portion 250, thereby allowing the towing portion 250 to move forward and backward. When the locking portion 280 is a notch (slit) provided on the hole 270 side, the locking portion 280 can be released from the notch when the surgeon applies a tension of a predetermined level or more to the towing portion 250, thereby allowing the towing portion 250 to move forward and backward.

[0068] Furthermore, the material of the engaging portion 280 is not particularly limited as long as it has elasticity, but it is preferable that the engaging portion 280 is made of a biodegradable material. When the engaging portion 280 is degraded in vivo, 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 off into the jejunum B2. When the engaging portion 280 is made of a biodegradable material, the traction portion 250 may be made of a non-biodegradable material.

[0069] There are no particular limitations on the material of which the engaging portion 280 is made, and it may be made of, for example, thermoplastic elastomers such as polyvinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), or other thermoplastic resins such as nylon or PET, or rubber, silicone elastomer, or the like.

[0070] Furthermore, 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 portion 210 by elastic deformation and can be locked into the hole 270. Furthermore, the shapes of the locking portions 280 may be the same as or different from each other.

[0071] As described above, the medical instrument 200 according to this embodiment includes the main body section 210, the fixed section 220, the operation section 230, and the auxiliary section 240. However, the medical instrument 200 may be configured with the main body section 210, the fixed section 220, and the operation section 230. The traction section 250 does not need to be configured integrally with the main body section 210. In this case, the surgeon prepares the traction section 250 separately from the medical instrument 200 when performing the procedure. The surgeon can use the medical instrument 200 and the traction section 250 in appropriate combination according to the progress of the procedure, etc.

[0072] As described above, the medical device 200 of this embodiment is placed between the pancreatic parenchyma B1 and the jejunum B2 (a pair of digestive tracts to be joined) and has a main body portion 210 (tubular member) with a lumen L, and a fixing portion 220 that generates a fixing force for fixing the main body portion 210 to the pancreatic parenchyma B1 (at least one of the digestive tracts), and the fixing portion 220 is configured so that its outer shape (outer diameter r1) can be expanded by an external force.

[0073] According to the above medical instrument 200, the fixing part 220 expands the outer shape (outer diameter r1) of the medical instrument 200, thereby expanding the inner wall of the pancreatic duct B1b, and thereby increasing the fitting force (resistance force) of the medical instrument 200 to the pancreatic parenchyma B1. Therefore, the fixing part 220 can fix the main body part 210 to the pancreatic duct B1b. Therefore, when the surgeon inserts the medical instrument 200 once into the pancreatic duct B1b and fixes the main body part 210 to the pancreatic duct B1b by the fixing part 220, the state in which the medical instrument 200 is inserted into the lumen (pancreatic duct B1b) of the pancreatic parenchyma B1 can be maintained. In addition, the surgeon can move the needle around the cut surface B1a of the pancreatic parenchyma B1 (the front wall B1d and the rear wall B1c) and the jejunum B2 without inserting or removing the medical instrument 200 from the pancreatic duct B1b, thereby joining the pancreatic parenchyma B1 and the jejunum B2. Therefore, the surgeon 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.

[0074] Moreover, the medical instrument 200 includes an operating part 230 that transmits an external force to the fixing part 220 to thereby deform the fixing part 220. Therefore, the surgeon can easily join the pancreatic parenchyma B1 and the jejunum B2.

[0075] The operation unit 230 also includes a traction unit 250 that applies an external force to the fixed unit 220 by being pulled, compressing the fixed unit 220 in the axial direction X, and a connection unit 260 that enables connection of the traction unit 250 to the main body unit 210. Therefore, the surgeon can deform the fixed unit 220 without directly applying an external force to the fixed unit 220.

[0076] Moreover, the medical instrument 200 further includes an auxiliary unit 240 that maintains a state in which the operating unit 230 transmits an external force to the fixing unit 220. Therefore, the surgeon can maintain the expanded state of the medical instrument 200 even while the surgeon is not operating the operating unit 230.

[0077] The auxiliary section 240 is formed in the main body section 210, and is disposed on the base end side (more central side than the fixing section 220 formed on one end side of the main body section 210) than the fixing section 220 formed on the tip side (end section in the axial direction X) of the main body section 210, and includes a hole section 270 (insertion hole) that exposes the towing section 250 to the outside when the towing section 250 is inserted into the lumen L, and a locking section 280 that is provided in at least one of the towing section 250 and the hole section 270 and is configured to be able to lock at least a part of the towing section 250 to the hole section 270. Therefore, when the surgeon pulls the towing section 250, the surgeon can maintain the towing state by locking one of the locking sections 280 provided in the towing section 250 to the hole section 270 of the main body section 210. Therefore, the surgeon can maintain the expanded state of the medical device 200 by the locking section 280.

[0078] Moreover, the fixing part 220 has a plurality of holes 221 provided on the tip side (end in the axial direction X) of the main body part 210 and a plurality of beam parts 222 arranged between each of the holes 221, and when the fixing part 220 is compressed in the axial direction X by the traction part 250, each of the beam parts 222 is bent radially outward, thereby expanding the outer diameter r1. By expanding the outer shape (outer diameter r1) of the medical device 200, the inner wall of the pancreatic duct B1b can be pushed apart, and the fitting force (resistance force) of the medical device 200 against the pancreatic parenchyma B1 can be increased. Therefore, the fixing part 220 can fix the main body part 210 to the pancreatic duct B1b.

[0079] The medical instrument set 1 includes the above-mentioned medical instrument 200 and a fusion-promoting sheet 100 that is disposed between the pancreatic parenchyma B1 and the jejunum B2 to promote fusion between the pancreatic parenchyma B1 and the jejunum B2. This configuration can reduce the risk of postoperative suture failure in a procedure for joining a pair of digestive tracts, and can easily join the pancreatic parenchyma B1 and the jejunum B2 while suppressing leakage of pancreatic juice from the pancreatic duct B1b during the procedure.

[0080] Next, modified examples 1 to 3 of the medical device 200 according to the first embodiment will be described. In the description of modified examples 1 to 3, the same reference numerals are used for configurations common to the above-mentioned medical device 200, and the description thereof will be omitted as appropriate. Furthermore, the contents not specifically described in the description of the modified examples can be the same as those of the above-mentioned embodiment.

[0081] <Variation 1> 13 and 14 are diagrams illustrating a medical device 300 according to the first modification.

[0082] The medical device 300 has a main body portion 210 that is placed between the digestive tracts to be joined (pancreatic parenchyma B1 and jejunum B2), a fixing portion 320 that generates a fixing force so as to fix the main body portion 210 to at least one of the digestive tracts (pancreatic parenchyma B1), and an operating portion 330 that deforms the fixing portion 320 by transmitting an external force to the fixing portion 320.

[0083] As shown in FIG. 13, the fixing portion 320 in the first modified example may be composed of a plurality of holes 321 provided in a certain region on the tip side of the main body portion 210, and the tip sides of a plurality of wires 322 that are partially contained inside the main body portion 210 and can protrude from each of the holes 321 when compressed in the axial direction X by an external force.

[0084] In addition, the operating section 330 in accordance with the first modified example may be constituted by the base end side of a wire 322 that is arranged to protrude from the base end side of the main body section 210 and is configured to be capable of being pushed toward the tip side of the main body section 210.

[0085] A tip side of wire 322 according to Modification 1 is housed in a recess provided between an inner peripheral wall and an outer peripheral wall of main body 210. A base side of wire 322 is provided so as to protrude toward the base side of main body 210. The recess communicates with hole 321. Therefore, wire 322 is inserted into main body 210 so as to partially follow hole 321.

[0086] When the surgeon operates the operation section 330 (pushes the wire 322 protruding from the base end side of the main body section 210 toward the tip end side), the wire 322 is compressed in the axial direction X and bent outward in the radial direction (diameter direction), as shown in Fig. 14. Then, the bent portion of the wire 322 protrudes from the hole section 321. In this manner, the surgeon can apply an external force to the wire 322 to expand the outer shape (outer diameter) of the medical device 300 into a circular shape (radially).

[0087] By adjusting the length of the hole 321 and the length of the wire 322, the surgeon can change the outer diameter of the fixing portion 320 after expansion and the shape of the wire 322 after deformation, thereby adjusting the fixing force of the medical device 300 to the digestive tract.

[0088] The wire 322 is preferably an alloy having elasticity or shape memory and biodegradability, and may be made of, for example, Mg or an alloy mainly composed of Mg. Since the wire 322 has elasticity or shape memory, it can maintain its shape after being deformed by an external force. Therefore, the medical device 300 can maintain its expanded state. Furthermore, since the wire 322 has biodegradability, its strength decreases when it is decomposed in the living body. Therefore, the medical device 300 releases its expanded state after a predetermined period of time has elapsed since being placed in the living body, and can naturally fall off into the jejunum B2.

[0089] <Variation 2> 15 and 16 are diagrams illustrating a medical device 400 according to the second modification.

[0090] The medical device 400 has a main body portion 210 that is placed between the digestive tracts to be joined (pancreatic parenchyma B1 and jejunum B2), a fixing portion 420 that generates a fixing force so as to enable the main body portion 210 to be fixed to at least one of the digestive tracts (pancreatic parenchyma B1), and an operating portion 430 that deforms the fixing portion 420 by transmitting an external force to the fixing portion 420.

[0091] As shown in FIG. 15, the fixing portion 420 in the second modification may be formed of a wire 421 that is connected to the tip side of the main body portion 210 and the operation portion 430 described later and is arranged to wind around the main body portion 210 in a spiral shape.

[0092] Furthermore, the operation section 430 according to the second modification may be configured by a grip section that is provided on the base end side of the main body section 210 and configured to be rotatable about the circumferential direction θ of the main body section 210.

[0093] When the surgeon operates the operation unit 430 (rotates it in the opposite direction to the winding direction of the wire 421), the winding diameter of the wire 421 increases as shown in Fig. 16. Therefore, the surgeon can apply an external force to the wire 421 to expand the outer shape (outer diameter) of the medical device 400.

[0094] By adjusting the amount of operation of the operation portion 430, the surgeon can change the outer diameter of the fixing portion 420 after the diameter expansion, and adjust the fixing force of the medical instrument 400 to the digestive tract.

[0095] The wire 421 may be made of the same material as the wire 322 of the first modification.

[0096] Furthermore, there is no particular limitation on the cross-sectional shape of the wire 421. The wire 421 may be partially provided with protrusions, which can increase the engagement force (resistance force) of the wire 421 with respect to the pancreatic parenchyma B1.

[0097] The form of the connection 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 210. The method of connecting the operation unit 430 and the main body 210 is not particularly limited. For example, the main body 210 and the operation unit 430 can be connected by providing a protrusion or the like in 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, for example, it can be made of a material having biodegradability or a material having water solubility. By configuring in this way, when the protrusion is decomposed in the living body, the lumen L of the main body 210 is expanded. Therefore, it is possible to secure a discharge route for discharging pancreatic juice from the pancreatic duct B1b to the jejunum B2.

[0098] <Variation 3> 17 and 18 are diagrams illustrating a medical device 500 according to the third modification.

[0099] The medical device 500 has a main body portion 510 that is placed between the digestive tracts to be joined (pancreatic parenchyma B1 and jejunum B2), a fixing portion 520 that generates a fixing force so as to enable the main body portion 510 to be fixed to at least one of the digestive tracts (pancreatic parenchyma B1), and an operating portion 530 that deforms the fixing portion 520 by transmitting an external force to the fixing portion 520.

[0100] The main body 510 according to the third modification is preferably made of an alloy having elastic plasticity or shape memory and biodegradability, and is made of, for example, Mg or an alloy containing Mg as a main component.

[0101] As shown in FIG. 17, the fixing portion 520 in the third modification may be composed of a plurality of holes 521 provided in a certain region on the tip side of the main body portion 510, and a plurality of beam portions 522 each arranged between each of the holes 521.

[0102] The operation section 530 according to the third modification may be configured by using a certain region on the base end side of the main body section 510 as a grip section.

[0103] When the surgeon operates the operating section 530 (twists the base end side of the main body section 510), the fixed section 520 is deformed into a spiral shape, and the beam section 522 is bent outward in the radial direction (diameter direction), as shown in Fig. 18. In this manner, the surgeon can apply an external force to the fixed section 520 to expand the outer shape (outer diameter) of the medical device 500.

[0104] By adjusting the length and inclination angle of the hole 321, the surgeon can change the outer diameter of the fixing portion 320 after expansion and the outer shape when viewed from the axial direction X, and adjust the fixing force of the medical device 200 to the digestive tract.

[0105] <Embodiment of treatment method (biological organ anastomosis)> Next, a treatment method using the medical instrument set will be described.

[0106] FIG. 19 is a flow chart showing each procedure of a treatment method using the medical instrument set.

[0107] The treatment method includes placing a medical instrument between one site to be joined and the other site to be joined of the biological organ (S11); inserting a healing promotion sheet having a sheet-like main body portion that promotes healing of biological tissues into the medical instrument and fixing the medical instrument to one of the sites to be joined (S12); and joining one site to be joined and the other site to be joined with at least a part of the main body portion of the healing promotion sheet placed between the one site to be joined and the other site to be joined (S13).

[0108] The biological organs to be joined by the treatment method and the parts to be joined in the biological organs are not particularly limited and can be selected arbitrarily. In the following description, pancreaticojejunostomy is taken as an example. In addition, as the medical instrument set used in each procedure described below, for example, any one of the medical instrument sets described above can be selected, or other medical instrument sets can be selected. However, in the following description, an example of use of the medical instrument set 1 shown in FIG. 1 will be described as a representative example that can be suitably used in each procedure. In addition, detailed descriptions of known procedure procedures and known medical devices and medical instruments, etc. will be omitted as appropriate in each procedure described below.

[0109] Hereinafter, in the description of this specification, "arranging a fusion-promoting sheet (or medical device) between biological organs" means at least one of the following: arranging the fusion-promoting sheet (or medical device) in direct or indirect contact with the biological organ, arranging the fusion-promoting sheet (or medical device) in a state where a spatial gap is formed between the biological organ and the fusion-promoting sheet (or medical device), or arranging the fusion-promoting sheet (or medical device) in both states (for example, arranging the fusion-promoting sheet (or medical device) in a state where it is in contact with one biological organ and not in contact with the other biological organ). In addition, in the description of this specification, "periphery" does not specify a strict range (area), but means a predetermined range (area) as long as the purpose of the treatment (joining of biological organs) can be achieved. In addition, the order of the procedure procedures described in each treatment method can be appropriately changed as long as the purpose of the treatment can be achieved. In addition, in the description of this specification, "relatively approaching" means both bringing two or more objects to be brought close to each other and bringing only one close to the other.

[0110] <Embodiment of treatment method (pancreaticojejunostomy)> FIG. 20 is a flow chart showing the procedure of an embodiment of a treatment method (pancreatic parenchyma-jejunal anastomosis), and FIGS. 21 to 26 are diagrams explaining pancreatic parenchyma-jejunal anastomosis.

[0111] In the treatment method according to this embodiment, the biological organs to be joined are the pancreatic parenchyma B1 and the jejunum B2 after pancreaticoduodenectomy. In the following description, a procedure for joining the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 (one part to be joined) to an arbitrary part of the intestinal wall of the jejunum B2 (the other part to be joined) will be described.

[0112] As shown in FIG. 20, the treatment method according to this embodiment includes preparing a medical instrument set 1 having a healing promotion sheet 100 and a medical instrument 200 (S101), inserting and positioning the medical instrument 200 in the pancreatic duct B1b (S102), attaching the healing promotion sheet 100 to the medical instrument 200 (S103), inserting the medical instrument 200 into the jejunum B2 (S104), and suturing the pancreatic parenchyma B1 and the jejunum B2 (S105).

[0113] Next, an example of the treatment method according to this embodiment will be specifically described with reference to Figures 21 to 26. Note that in Figure 26, a plurality of double-ended needles 920a to 920e, which will be described later, are omitted.

[0114] First, the surgeon prepares a medical instrument set 1 having a healing-promoting sheet 100 and a medical instrument 200 (S101).

[0115] Next, as shown in FIG. 21, the surgeon inserts the medical instrument 200 into the pancreatic duct B1b from the tip side of the main body 210 (the tip opening 210A side shown in FIG. 1). Then, the surgeon can fix the medical instrument 200 to the pancreatic parenchyma B1 (S102). At this time, the surgeon can expand the outer shape (outer diameter r1) of the fixing part 220 by pulling the traction part 250 and compressing the fixing part 220 in the axial direction X (see FIG. 22). In addition, the surgeon can maintain the traction force of the traction part 250 against the main body 210 by engaging the locking part 280 formed on the traction part 250 with the hole part 270 of the main body 210. Therefore, the surgeon can fix the position of the medical instrument 200 with respect to the pancreatic duct B1b by the fixing part 220.

[0116] Next, as shown in Fig. 23, the surgeon forms holes 120 (see Fig. 1) in the healing promotion sheet 100 and attaches it to the medical device 200 (S103). The device used by the surgeon to form the holes 120 is not particularly limited. The holes 120 may be formed in the healing promotion sheet 100 before use. The surgeon may insert the medical device 200 into the pancreatic duct B1b after inserting the medical device 200 into the holes 120 of the healing promotion sheet 100.

[0117] Next, the surgeon inserts the base end side (the base end opening 210B side shown in FIG. 1) of the main body 210 into the jejunum B2 (S104). This forms a drainage path for draining pancreatic juice from the pancreatic duct B1b into the jejunum B2 (see FIG. 26), and can prevent the pancreatic juice from the pancreatic duct B1b from leaking into the junction of the pancreatic parenchyma B1 and the jejunum B2.

[0118] Next, as shown in Fig. 24, the surgeon places the fusion promotion 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, an example of a procedure for fixing the fusion promotion sheet 100 to the pancreatic parenchyma B1 using a plurality of double-ended needles 920a-920e as fixing members will be described. The double-ended needles 920a-920e may be known ones having a bioabsorbable suture (suture) and biocompatible needle portions attached to both ends of the absorbable suture.

[0119] First, the surgeon moves the double-ended needle 920a from the posterior wall B1c of the pancreatic parenchyma B1 (the circumferentially dorsal portion of the pancreatic parenchyma B1) and the portion of the fusion promotion sheet 100 that is located on the posterior wall B1c, toward the anterior wall B1d of the pancreatic parenchyma B1 (the circumferentially ventral portion of the pancreatic parenchyma B1) and the portion of the fusion promotion sheet 100 that is located on the anterior wall B1d.

[0120] Next, the surgeon moves the double-ended needle 920a so as to pass through the jejunal serosa muscularis layer at the site of the jejunum B2 to be anastomotically connected (around the through-hole B2a formed in the jejunum B2). The surgeon repeats this operation to pass the multiple double-ended needles 920a-920e through the healing promotion sheet 100, the pancreatic parenchyma B1, and the jejunal serosa muscularis layer of the jejunum B2. In this manner, the surgeon can fix the healing promotion sheet 100 to the pancreatic parenchyma B1 using the multiple double-ended needles 920a-920e that suture the pancreatic parenchyma B1 and the jejunum B2.

[0121] The number of double-ended needles to be inserted into the pancreatic parenchyma B1 and the jejunal serosa muscular layer of the jejunum B2 and the positions at which the double-ended needles are inserted are not particularly limited. Also, the surgeon may fix the healing-promoting sheet 100 to the pancreatic parenchyma B1 using a biodegradable staple or the like as a fixing member, instead of the multiple double-ended needles 920a to 920e.

[0122] Next, the surgeon ligates the double-ended needles 920a-920e while pressing the jejunum B2 against the pancreatic parenchyma B1 with the surgeon's fingers, as shown in Fig. 25. This causes the pancreatic parenchyma B1 and the jejunum B2 to be sutured together with the fusion-promoting sheet 100 sandwiched between them (see Fig. 26). The jejunum B2 deforms due to tension generated during suturing, so as to envelop the cut surface B1a of the pancreatic parenchyma B1 and the main body 110 of the fusion-promoting sheet 100.

[0123] The surgeon can place the main body 110 of the healing promotion sheet 100 between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 by the above operation. The surgeon can also place the medical device 200 between the pancreatic parenchyma B1 and the jejunum B2 as a so-called internal fistula tube. The main body 110 of the healing promotion 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 both, thereby promoting healing of the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2. The medical device 200 naturally falls off into the jejunum B2 and is led out of the body after a predetermined period (several weeks to several months) has elapsed since the surgeon anastomoses the biological organs.

[0124] As described above, the treatment method according to this embodiment is applied to a procedure for joining pancreatic parenchyma B1 and jejunum B2. In addition, in the treatment method described above, the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 (jejunal serosa muscularis layer) are joined. According to this treatment method, the main body 110 of the healing-promoting sheet 100 sandwiched between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 can promote healing of the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2, thereby reducing the risk of suture failure after pancreatic parenchyma-jejunum anastomosis.

[0125] The present invention is not limited to the above-described embodiment, and various modifications are possible within the scope of the claims. For example, although the healing-promoting sheet and the medical device are described above as separate entities, they may be integrated together.

[0126] Also, in the above, an embodiment of the medical instrument in which the fixing portion is disposed on one side of the main body portion in the axial direction X has been described. However, as long as the shape of the fixing portion is such that it is easy to engage with the biological lumen in which the medical instrument is disposed, the fixing portion 220 may be disposed on both sides of the main body portion 210 in the axial direction X, as shown in FIG. 27. By providing the fixing portion 220 on both sides of the medical instrument 200A in this way, it is expected that the fixing force of the medical instrument to the biological organ will be increased (see FIG. 28). Note that the traction portions 250 for traction of the fixing portions 220 disposed on both sides of the main body portion 210 may be connected to each other. This allows the surgeon to operate the fixing portions 220 disposed on both sides of the main body portion 210 at once.

[0127] In addition, although the above describes an embodiment of the medical device in which one fixing part is provided on one side of the main body part in the axial direction X, multiple fixing parts may be provided on one end side of the medical device. In this case, it is preferable that the distance between one fixing part and the other fixing part is narrower than the height (see t1 shown in FIG. 4) of the beam part that protrudes radially from the outer circumferential surface of the main body part when the medical device is in an expanded state. This makes it possible to suppress the possibility that each of the fixing parts will fall radially inward due to repulsion against the inner wall of the digestive tract. Therefore, with the fixing parts arranged in this manner, it is possible to suppress the fixing force of the medical device to the digestive tract from decreasing during the procedure.

[0128] Furthermore, in the case where a plurality of fixing parts are provided on one end side of the medical instrument, when an external force is applied to the main body part by the traction part, the main body part may bend in a W shape starting from each of the fixing parts when viewed from a direction perpendicular to the axial direction X. With fixing parts arranged in this manner, the outer shape of the medical instrument can be expanded, and it is expected that the fixing force of the medical instrument to the digestive tract can be more secure.

[0129] Furthermore, when multiple fixing parts are provided on one end side of the medical device, a tubular member (hereinafter referred to as an internal tube) may be further provided in the lumen of the main body part. The internal tube can prevent the main body part from bending in a W-shape when viewed from a direction perpendicular to the axial direction X with each fixing part as a starting point when an external force is applied by the traction part, and can facilitate the passage of pancreatic juice through the lumen of the main body part. Furthermore, the internal tube can assist the fixing parts so that the external force is uniformly transmitted to the multiple beam parts when an external force is applied by the traction part. Therefore, the internal tube can uniformly expand the fixing parts to maintain the fixing force of the medical device.

[0130] The outer diameter of the internal tube is not particularly limited as long as it is smaller than the inner diameter of the main body. The material of the internal tube is not particularly limited as long as it can be made of a material harder than the main body or the fixing part. The length of the internal tube in the axial direction X is not particularly limited, but the distal end of the internal tube is preferably arranged distally of one fixing part (fixing part on the distal side) arranged on the distal side of the main body, and the proximal end of the internal tube is preferably arranged proximal of another fixing part (fixing part on the distal side) arranged proximal of the one fixing part. Therefore, the internal tube preferably extends from the connection part to the hole, and more preferably extends from the connection part to the fixing part on the distal 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 connection part. When the internal tube is not connected to the main body, a lubricating coating such as silicone oil may be applied to the inner surface of the main body and the outer surface of the internal tube. In this case, the lubricity of the internal tube to the main body is improved, and the internal tube can move more smoothly through the lumen of the main body. Therefore, the force required by the surgeon to pull the traction part can be reduced. The material that gives slipperiness to the inner surface of the main body and the outer surface of the internal tube is not limited to the lubricating coating described above, and can be a combination of materials with a small coefficient of friction.

[0131] Also, in the above, an embodiment in which the main body part is arranged to function as an internal fistula tube has been described. However, the main body part may be arranged to function as an external fistula tube. In this case, the main body part is arranged from inside the body toward the outside of the body so as to penetrate the pancreatic parenchyma, the jejunum, and the skin. The end of the main body part facing the outside of the body is connected to a drainage bag, so that pancreatic juice can be drained outside the body. After a predetermined period of time has passed, the main body part is led out of the body by the surgeon pulling the main body part.

[0132] This application is based on Japanese Patent Application No. 2020-60482 filed on March 30, 2020, the disclosure of which is incorporated by reference in its entirety. [Explanation of symbols]

[0133] 1 medical instrument set, 100 Healing promotion sheet, 200 medical instruments, 210 main body portion (tubular member), 220 Fixed part, 221 hole, 222 beam section, 230 Operation section, 240 Auxiliary Department; 250 traction section, 260 Connection part, 270 Hole (insertion hole), 280 Locking part.

Claims

1. A tubular member having a lumen and disposed between a pair of digestive tracts to be joined; a fixing part that generates a fixing force for fixing the tubular member to at least one of the digestive tracts and is expandable in outer shape by an external force; an operation unit that transmits the external force to the fixed portion to deform the fixed portion; an auxiliary unit that maintains a state in which the operation unit transmits the external force to the fixed unit, the operation unit includes a traction unit that applies the external force to the fixing unit by being pulled, thereby compressing the fixing unit in the axial direction, and a connection unit that enables connection of the traction unit to the tubular member, the auxiliary portion is formed on the tubular member, positioned toward the center of the fixing portion formed at the axial end of the tubular member, and has an insertion hole that exposes the towing portion to the outside when the towing portion is inserted into the lumen.

2. The medical instrument according to claim 1 , wherein the auxiliary portion further comprises a locking portion provided on at least one of the traction portion and the insertion hole, and configured to be able to lock at least a portion of the traction portion to the insertion hole.

3. the fixing portion has a plurality of holes provided at an end portion in the axial direction of the tubular member, and a plurality of beam portions respectively disposed between the respective holes, The medical device according to claim 1 or 2, wherein when the fixation portion is compressed in the axial direction by the traction portion, the external shape is expanded by bending each of the beam portions radially outward.

4. The medical device according to any one of claims 1 to 3, and a healing promotion sheet that is placed between the pair of digestive tracts to promote healing of the pair of digestive tracts.

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