Medical device and medical device kit

Abstract

The medical device 200 according to the present application includes a main body 210 disposed between the pancreas B1 and the jejunum B2 and having a lumen L, and a fixing portion 220 configured to generate a fixing force for fixing the main body to the pancreas B1, the fixing portion being configured to be expandable in shape by an external force.

Description

TECHNICAL FIELD

[0001] The present application relates to a medical instrument and a medical instrument kit. BACKGROUND

[0002] As one of the procedures for joining a pair of biological organs by surgery (for example, anastomosis of digestive tracts), a procedure for joining the pancreatic parenchyma and the jejunum is known. As one of the treatment methods for a tumor in the vicinity of the head of the pancreas, a pancreaticoduodenectomy in which the head of the pancreas and the surrounding tissue are resected is known. After the pancreaticoduodenectomy, the procedure for joining the pancreatic parenchyma and the jejunum is performed.

[0003] In the procedure for joining the pancreatic parenchyma and the jejunum, a suture member such as a biodegradable suture is used to suture the pancreatic parenchyma and the jejunum. In addition, in the procedure for joining the pancreatic parenchyma and the jejunum, a pancreatic duct catheter is sometimes used to suppress leakage of pancreatic juice discharged from the pancreatic duct to the joining portion where the pancreatic parenchyma and the jejunum are joined (for example, see Patent Literature 1 below). In the case of the pancreatic duct catheter, the pancreatic duct catheter is left in the body in a state in which one end portion of the pancreatic duct catheter is inserted into the pancreatic duct and the other end portion of the pancreatic duct catheter is led to the outside of the body via the inside of the jejunum or the like. The pancreatic duct catheter that is left in the body suppresses leakage to the joining portion by discharging the pancreatic juice discharged from the pancreatic duct to the outside of the body.

[0004] Prior Art Documents

[0005] Patent Literature

[0006] Patent Literature 1: Japanese Patent Application Laid-Open No. 2007-167540 SUMMARY

[0007] Problems to be Solved by the Invention

[0008] The present inventors have conducted intensive studies on a medical instrument that can simply join a pair of digestive tracts such as the jejunum and the pancreatic parenchyma.

[0009] Thus, an object of the present application is to provide a medical instrument that can simply join a pair of digestive tracts.

[0010] Means for Solving the Problems

[0011] The medical instrument of the present application related to the achievement of the above object has: a tubular member that is disposed between a pair of digestive tracts that are to be joined and that has an inner lumen; and a fixing portion that generates a fixing force configured to enable the tubular member to be fixed to at least one of the digestive tracts, the fixing portion being configured to be able to expand in shape by an external force.

[0012] Effects of the Invention

[0013] The medical instrument and the medical instrument kit of the present application related to the present application are configured in the above-described manner and thus can simply join a pair of digestive tracts. Attached Figure Description

[0014] Figure 1 This is a diagram illustrating a medical device kit according to one embodiment of the present invention.

[0015] Figure 2 This is an enlarged cross-sectional view showing the through-hole of the healing-promoting sheet that constitutes the medical device kit.

[0016] Figure 3 It is used to show Figure 1 Side view of the fixation part of the medical device in question.

[0017] Figure 4 It is used to show Figure 1 A side view of the expanded state of the fixation part of the medical device in question.

[0018] Figure 5 It is along Figure 4 An enlarged sectional view of line 5-5.

[0019] Figure 6 This is a schematic diagram illustrating a modified example of the hole that constitutes the fixing part.

[0020] Figure 7 It is used to show Figure 6 A cross-sectional view of the expanded state of the fixation part of the medical device in question.

[0021] Figure 8 This is a schematic diagram illustrating a modified example of the hole that constitutes the fixing part.

[0022] Figure 9 This is a schematic diagram illustrating a modified example of the hole that constitutes the fixing part.

[0023] Figure 10 It is used to show Figure 9 A cross-sectional view of the expanded state of the fixation part of the medical device in question.

[0024] Figure 11 This is a schematic diagram illustrating a modified example of the hole that constitutes the fixing part.

[0025] Figure 12 It is used to show Figure 11 A side view of the expanded state of the fixation part of the medical device in question.

[0026] Figure 13 It is used to show Figure 1 A schematic diagram of a variation of the medical device involved, Example 1.

[0027] Figure 14 It is used to show Figure 13 A side view of the expanded state of the fixation part of the medical device in question.

[0028] Figure 15 is a schematic view for illustrating a modification example 2 of the medical instrument. Figure 1 is a schematic view for illustrating an expanded state of the fixing portion of the medical instrument.

[0029] Figure 16 is a schematic view for illustrating a modification example 3 of the medical instrument. Figure 15 is a schematic view for illustrating an expanded state of the fixing portion of the medical instrument.

[0030] Figure 17 is a schematic view for illustrating a modification example 3 of the medical instrument. Figure 1 is a schematic view for illustrating an expanded state of the fixing portion of the medical instrument.

[0031] Figure 18 is a schematic view for illustrating a modification example 3 of the medical instrument. Figure 17 is a schematic view for illustrating an expanded state of the fixing portion of the medical instrument.

[0032] Figure 19 is a flowchart showing each step of a treatment method using the medical instrument.

[0033] Figure 20 is a flowchart showing steps of an embodiment of the treatment method (pancreatic parenchyma-jejunum anastomosis).

[0034] Figure 21 is a schematic sectional view for explaining the pancreatic parenchyma-jejunum anastomosis.

[0035] Figure 22 is a schematic sectional view for explaining the pancreatic parenchyma-jejunum anastomosis.

[0036] Figure 23 is a schematic sectional view for explaining the pancreatic parenchyma-jejunum anastomosis.

[0037] Figure 24 is a schematic perspective view for explaining the pancreatic parenchyma-jejunum anastomosis.

[0038] Figure 25 is a schematic perspective view for explaining the pancreatic parenchyma-jejunum anastomosis.

[0039] Figure 26 is a schematic sectional view for explaining the pancreatic parenchyma-jejunum anastomosis.

[0040] Figure 27 is a view showing a medical instrument kit in which fixing portions are formed at both end portions of the medical instrument.

[0041] Figure 28 is a schematic sectional view for explaining the pancreatic parenchyma-jejunum anastomosis using the medical instrument kit shown in Figure 27 DETAILED DESCRIPTION ​

[0042] Embodiments of the present application will be described below with reference to the accompanying drawings. Note that the following description is not intended to limit the technical scope of the present application described in the claims. In addition, the dimensional ratios of the drawings are exaggerated for clarity in some cases.

[0043] <First Embodiment>

[0044] <Medical Instrument Set>

[0045] Figure 1 is a view for explaining a medical instrument set according to one embodiment of the present application.

[0046] As Figures 21 to 26 indicated, the medical instrument set can be applied to a surgery for joining prescribed biological organs to each other (e.g., an anastomosis of a digestive tract). As described later, in the description of the present specification, as an example of a surgery using the medical instrument set, a pancreatic parenchyma-jejunum anastomosis for joining a pancreatic parenchyma Bl to a jejunum B2 is described.

[0047] The medical instrument set has a healing-promoting sheet 100 and a medical instrument 200.

[0048] <Healing-Promoting Sheet 100>

[0049] Figure 2 is an enlarged sectional view showing a through-hole 112 of the healing-promoting sheet 100 constituting the medical instrument set.

[0050] As Figure 1 indicated, the healing-promoting sheet 100 is formed of a biodegradable sheet having a plurality of through-holes 112, and has a main body portion 110 for promoting healing of a biological tissue.

[0051] As Figure 1 and Figure 2 indicated, the main body portion 110 is constituted of a sheet-like member.

[0052] As Figure 1 and Figure 2 indicated, each through-hole 112 formed in the main body portion 110 is regularly and periodically arranged in the surface direction of the main body portion 110. Note that each through-hole 112 can also be arranged randomly at each portion in the surface direction of the main body portion 110.

[0053] As Figure 2 indicated, each through-hole 112 extends substantially perpendicularly between the surface 111 and the back surface 113 in the thickness direction (the up-down direction of Figure 2 ) of the main body portion 110. Note that in a cross section of the main body portion 110 along the thickness direction, each through-hole 112 can also be zigzagged or curved between the surface 111 and the back surface 113.

[0054] Each through hole 112 has a generally circular planar shape (the shape when viewed from above on the surface 111 or the back 113 of the main body 110). The planar shape of each through hole 112 is not particularly limited and can be, for example, elliptical, polygonal (rectangular, triangular, etc.). Furthermore, the planar shape and cross-sectional shape of each through hole 112 can also be different.

[0055] The main body 110 has a generally circular planar shape. The planar shape of the main body 110 is not particularly limited and can be, for example, elliptical, polygonal (rectangular, triangular, etc.). Furthermore, the planar shape and cross-sectional shape of each through hole 112 can also be different.

[0056] The thickness of the main body 110 ( Figure 2 The dimension T shown is not particularly limited, but is preferably 0.05 mm to 0.3 mm, and more preferably 0.1 mm to 0.2 mm. When the thickness of the main body 110 is 0.05 mm or more (especially 0.1 mm or more), it has sufficient strength to prevent the main body 110 from breaking during the operation of the healing promotion sheet 100. On the other hand, when the thickness of the main body 110 is 0.3 mm or less (especially 0.2 mm or less), it has sufficient softness to allow the main body 110 to adhere tightly to and follow the biological tissue to which it is applied.

[0057] For the main body 110, the diameter D of the through hole 112 is relative to the spacing P of the through hole 112 (e.g., Figure 2 As shown, a ratio of the distance between adjacent through holes 112 to that between 0.25 and 40 is preferred. It should be noted that when the planar shape of the through hole 112 is a perfect circle, the aperture D of the through hole 112 becomes 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 aperture D of the through hole 112 can be set as the diameter of a perfect circle (equivalent circle diameter) having an area equal to the area of ​​the opening of the through hole 112 (the portion of the through hole 112 facing the surface 111 or the back surface 113).

[0058] The main body portion 110 has a plurality of through-holes 112, and thus there are a plurality of values of the aperture D corresponding to each of the through-holes 112. Thus, in the present embodiment, when calculating the above-mentioned ratio, the arithmetic mean of two or more of the values of the aperture D corresponding to the plurality of through-holes 112 is used as a representative value of the aperture D. On the other hand, the pitch P of the plurality of through-holes 112 is defined by the shortest distance between the opening portions of two through-holes 112. Also, with respect to the value of the pitch P, there are a plurality of values of the pitch P corresponding to combinations of adjacent through-holes 112. Thus, in the present embodiment, when calculating the above-mentioned ratio, the arithmetic mean of two or more of the values of the pitch P corresponding to the combinations of adjacent through-holes 112 is used as a representative value of the pitch P.

[0059] Note that the pitch P, the aperture D, the ratio of the aperture D to the pitch P, and the like of the above-mentioned through-holes 112 are examples, and are not limited thereto.

[0060] The main body portion 110 can be composed of a biodegradable material. The material constituting the main body portion 110 is not particularly limited, and for example, a biodegradable resin can be given. As the biodegradable resin, for example, a known biodegradable (co)polymer described in Japanese Patent Application Publication No. 2011-528275, Japanese Patent Application Publication No. 2008-514719, International Publication No. 2008-1952, Japanese Patent Application Publication No. 2004-509205, and the like can be used. Specifically, (1) a polymer selected from the group consisting of aliphatic polyesters, polyesters, polybasic acid anhydrides, polyortho esters, polycarbonates, polyphosphazenes, polyphosphoesters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and celluloses; and (2) a copolymer composed of one or more monomers constituting the above-mentioned (1) can be given. That is, it is preferable that the biodegradable sheet contain at least one biodegradable resin selected from the group consisting of a polymer selected from the group consisting of aliphatic polyesters, polyesters, polybasic acid anhydrides, polyortho esters, polycarbonates, polyphosphazenes, polyphosphoesters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and celluloses, and a copolymer composed of one or more monomers constituting the polymer.

[0061] The method of manufacturing the main body portion 110 is not particularly limited, and for example, a method of manufacturing a sheet in a net shape using a fiber composed of the above-mentioned biodegradable resin can be given. The method of manufacturing a fiber composed of a biodegradable resin is not particularly limited, and for example, an electrospinning method (electric field spinning method, electrospinning method), a melt-blowing method, and the like can be given. The main body portion 110 can select and use only one of the above-mentioned methods, or two or more of the above-mentioned methods can be selected and appropriately combined. Note that, as another example of the method of manufacturing the main body portion 110, a fiber composed of the above-mentioned biodegradable resin can be spun by a conventional method, and the thus manufactured fiber can be woven in a net shape to manufacture the biodegradable sheet member of the present application.

[0062] The main body portion 110 induces a biological reaction by a constituent material of the biodegradable resin that constitutes the main body portion 110. The main body portion 110 induces expression of a biological component such as fibrin by this action. The biological component induced in this way is accumulated in a manner of passing through the through-hole 112 of the main body portion 110, whereby healing can be promoted. Therefore, by disposing the main body portion 110 between the pancreas B1 and the jejunum B2, promotion of healing based on the above-described mechanism can be produced.

[0063] Note that the material of the healing-promoting sheet 100 can be biodegradable or can not be biodegradable as long as it can promote healing of a biological organ. In addition, the healing-promoting sheet 100 can promote healing of a biological organ as long as it can promote healing of a biological organ, and can not form the through-hole 112 regardless of the material.

[0064] <Medical instrument 200>

[0065] Next, the medical instrument 200 will be described. The medical instrument 200 can be used while maintaining a state in which the lumens of a pair of digestive tracts, such as the pancreas B1 and the jejunum B2, which are to be joined, are in communication. Figures 3 to 12 is a view for describing the medical instrument 200.

[0066] Note that in the following description, the one end portion side of the medical instrument 200 that can be inserted into the jejunum B2 will be referred to as the "base end side", and the other end portion side of the medical instrument 200 that can be inserted into the pancreas B1 will be referred to as the "distal end side". In addition, the direction from the distal end side toward the base end side (or the reverse direction thereof) will be referred to as the axial direction X.

[0067] The medical instrument 200 has a main body portion 210 (corresponding to a "tubular member") disposed between the digestive tracts (the pancreas B1 and the jejunum B2) to be joined, a fixing portion 220 that generates a fixing force for constituting the main body portion 210 so as to be fixed to at least one of the digestive tracts (the pancreas B1), an operation 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 a state in which the operation portion 230 transmits the external force to the fixing portion 220.

[0068] <Main body portion 210>

[0069] The main body portion 210 has an inner lumen L. In the present embodiment, the shape of the hollow cross section is constituted as a circular shape such as a circle or an ellipse. The outer diameter r1 and the inner diameter of the main body portion 210 are not particularly limited, and 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).

[0070] When the main body 210 is positioned between the pancreatic parenchyma B1 and the jejunum B2, pancreatic juice is introduced into the lumen L from the anterior side opening 210A, and the pancreatic juice is drained into the jejunum B2 from the basal side opening 210B.

[0071] The main body 210 can be made of a flexible, non-biodegradable material. After a prescribed period (several weeks to several months) following the anastomosis of the digestive tract by the surgeon and the placement of the main body 210 within the body, it naturally detaches into the jejunum B2 and is discharged from the body. That is, the main body 210 functions as a so-called arteriovenous fistula.

[0072] like Figure 1 , Figure 3 As shown, the main body 210 has at least one side hole 210P on the front end side. If the side hole 210P is disposed between the pancreatic parenchyma B1 and the jejunum B2, pancreatic juice is introduced into the lumen L and drained into the jejunum B2. Therefore, even when the front end opening 210A is blocked, the side hole 210P can still drain pancreatic juice into the jejunum B2.

[0073] There are no particular restrictions on the constituent materials of the main body 210. For example, it can be composed of thermoplastic elastomers such as vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), thermoplastic resins or rubber such as nylon and PET, and silicone elastomers.

[0074] <Fixed part 220>

[0075] like Figure 3 , Figure 4 As shown, the fixing part 220 is composed of a plurality of holes 221 provided in a certain area on the front end side of the main body part 210, and a plurality of beams 222 respectively disposed between the holes 221.

[0076] like Figure 4 As shown, when the fixing part 220 is compressed along the axial direction X by an external force, by bending each beam part 222 outward in the radial direction, the outer shape (outer diameter r1) of the medical device 200 can be expanded in a circular shape (radially) (see reference). Figure 5 ).

[0077] like Figure 4 , Figure 5 , Figure 7 , Figure 10 As shown, each hole 221 is exposed by bending outward along the radial direction.

[0078] The fixing part 220 expands 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) of the medical device 200 relative to the pancreatic parenchyma B1. Therefore, the fixing part 220 can fix the main body 210 to the pancreatic duct B1b.

[0079] When the surgeon inserts the medical instrument 200 into the pancreatic duct B1b in one go and fixes the main body 210 to the pancreatic duct B1b using the fixing part 220, the medical instrument 200 can be maintained in the lumen of the pancreatic parenchyma B1 (pancreatic duct B1b). Furthermore, the surgeon does not need to remove the medical instrument 200 from the pancreatic duct B1b; instead, by inserting needles around the cut surface B1a of the pancreatic parenchyma B1 (anterior wall B1d and posterior wall B1c) and in the jejunum B2, the pancreatic parenchyma B1 and jejunum B2 can be joined. Therefore, the surgeon can perform the anastomosis of the pancreatic parenchyma B1 and jejunum B2 without suturing the pancreatic duct B1b and jejunum B2, allowing for simple joining of the pancreatic parenchyma B1 and jejunum B2.

[0080] like Figure 5 As shown, there are 8 holes 221 and 8 beams 222. Furthermore, each hole 221 (and each beam 222) is spaced at a predetermined interval along the circumferential direction θ of the fixing part 220. It should be noted that the number of holes 221 and beams 222 is not particularly limited; preferably, 2 to 16 holes are provided, and more preferably, 4 to 8 holes are provided.

[0081] The hole 221 is a straight slit (slit) formed in the main body 210. For example... Figure 3 As shown, the length k of each hole 221 along the longitudinal direction is the same or approximately the same, preferably 3 to 8 mm. The method of manufacturing the hole 221 is not particularly limited, for example, it can be manufactured by laser processing.

[0082] like Figure 3 As shown, the hole 221 is formed in a manner that intersects the axial direction X. The inclination angle θ1 of the hole 221 relative to the axial direction X (the inclination angle of the imaginary line m1 of the hole 221 from the starting point 221a to the ending point 221b relative to the axial direction X) is preferably 0 to 89°, and more preferably 17 to 45°.

[0083] Additionally, the expanded outer diameter r2 of the fixing part 220 (refer to...) Figure 4 It is preferable that the inner diameter of the pancreatic duct B1b is 2 to 4 times that of 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 expanded fixing part 220 is preferably 4 to 8 mm, and more preferably 5 mm.

[0084] The operator can change the outer diameter r2 of the fixed portion 220 after the diameter expansion by adjusting the length k and the inclination angle θ1 of the hole portion 221, and adjust the fixing force (hereinafter referred to as the fixing force of the medical instrument 200) configured to be able to fix the main body portion 210 to the digestive tract.

[0085] It is preferable that the fixing force of the medical instrument 200 after the expansion be 1.1 to 4 times the fixing force before the expansion. Note that the fixing force refers to the maximum strength when the medical instrument 200 is pulled at a constant speed under the condition that the medical instrument 200 is held by the base end side with forceps or the like after the medical instrument 200 is inserted into the pancreas B1 and the outer diameter r1 of the medical instrument 200 is expanded with the fixed portion 220. In the case where the fixing force before the expansion is 1.2 to 1.7 N, it is preferable that the fixing force after the expansion be 2 to 5 N.

[0086] In addition, although the hole portion 221 is described above as being linear, the shape of the hole portion 221 is not particularly limited. The hole portion 221 may, for example, also be curved (refer to FIG. 8) such as an elliptical arc. Figure 6 By making the shape of the hole portion 221 curved such as an elliptical arc, it is possible to adjust the shape of the beam portion 222 observed from the axial direction X when the fixed portion 220 is compressed in the axial direction X by an external force (refer to Figure 5 , Figure 7 Thus, the operator can adjust the amount of contact (contact position) of the inner wall of the pancreatic duct B1b with the beam portion 222 and adjust the fixing force of the medical instrument 200 with respect to the digestive tract.

[0087] In addition, the hole portion 221 can also be a zigzag line formed by combining a plurality of straight lines (refer to FIG. 9). Figure 8 In this case, the beam portion 222 is bent obliquely with respect to the base end side when viewed from a direction orthogonal to the axial direction X when the fixed portion 220 is compressed in the axial direction X by an external force. Thus, it is possible to expect that the fixed portion 220 further generates the fixing force of the medical instrument 200 with respect to the digestive tract.

[0088] In addition, the hole portion 221 can also be spiral.

[0089] In addition, the direction in which the hole portion 221 extends is not particularly limited.

[0090] In addition, the arrangement of each hole portion 221 is not particularly limited. As shown in FIG. 10, the start point 221a (or the end point 221b) of each hole portion 221 can be arranged in line (at the same position with respect to the axial direction X of the main body portion 210) on the circumferential direction θ of the main body portion 210, or can be arranged so as to be offset with respect to the circumferential direction θ of the main body portion 210 as shown in FIG. 11. Figure 4 Figure 9 ​The illustrated to be configured in a zigzag shape (at positions different from each other with respect to the axial direction X of the main body portion 210).

[0091] As Figure 9 illustrated, in a case where the hole portions 221 are configured at positions different from each other with respect to 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, as Figure 10 illustrated, the outer shape of the medical instrument 200 can be expanded into a substantially rectangular shape.

[0092] In addition, as Figure 11 illustrated, one or more hole portions 223 having a length shorter than that of the hole portions 221 can be formed on the proximal end side of the beam portion 222. The proximal end side of the beam portion 222 has flexibility by being formed with the hole portions 223, as compared with the distal end side where the hole portions 223 are not formed. Thus, when the beam portion 222 is compressed in the axial direction X by an external force, as viewed from a direction orthogonal to the axial direction X, the beam portion 222 is bent obliquely toward the proximal end side (see Figure 12 ) as compared with the positions where the hole portions 221 are formed (between an imaginary line m2 indicating the position of a start point 221a of the hole portions 221 with respect to the axial direction X and an imaginary line m3 indicating an end point 221b). Thus, it is expected that the fixing portion 220 further generates a fixing force of the medical instrument 200 with respect to the alimentary canal.

[0093] <Operation portion 230, auxiliary portion 240>

[0094] As Figure 1 , Figure 3 , Figure 4 illustrated, the operation portion 230 has a pulling portion 250 that imparts an external force to the fixing portion 220 by being pulled, and a connection portion 260 that can connect the pulling portion 250 with the main body portion 210. In addition, as Figure 4 illustrated, the auxiliary portion 240 has a hole portion 270 (corresponding to a "penetration hole") that exposes the pulling portion 250 to the outside so as to at least partially penetrate the lumen L of the main body portion 210 from the connection portion 260 as a start point, and a locking portion 280 configured to be able to lock at least a part of the pulling portion 250 to the hole portion 270.

[0095] The pulling portion 250 can be a long strip-shaped member (for example, an elongated rope-shaped member, a belt-shaped member having a prescribed width) having a prescribed length and having a cross-sectional shape that can penetrate the lumen L of the main body portion 210, the hole portion 270. Note that the length and the like of the pulling portion 250 are not particularly limited.

[0096] The connection portion 260 is formed at the front end of the main body portion 210. The method of fixing the base end of the traction portion 250 to the front end side of the main body portion 210 is not particularly limited, and the connection can be performed by suturing, adhesive fixing, or using fusion, or the like, or the end of the traction portion 250 can be knotted in a ring shape and hooked to the front end of the main body portion 210.

[0097] The hole portion 270 is formed in the main body portion 210, and is disposed on the base end side (disposed on the central side compared to the fixing portion 220 formed on the end portion side of the main body portion 210) compared to the fixing portion 220 formed at the front end portion. The traction portion 250 in the present embodiment is inserted into the inner cavity L of the main body portion 210 from the connection portion 260 formed at the front end of the main body portion 210 to the hole portion 270 formed on the base end side of the main body portion 210, and can impart an external force to the fixing portion 220 by being pulled. Thus, the practitioner can deform the fixing portion 220 without directly applying an external force to the fixing portion 220. In addition, by providing the hole portion 270 on the side surface of the main body portion 210, the practitioner can adjust the position at which the traction portion 250 is pulled in accordance with the surgery.

[0098] The practitioner can impart an external force to the fixing portion 220 and compress the fixing portion 220 in the axial direction X by pulling the traction portion 250 in a state in which at least a portion of the traction portion 250 is inserted into the inner cavity L of the main body portion 210 (imparting a tension in the axial direction X to the traction portion 250).

[0099] The locking portion 280 is one or more protrusions provided in a certain range of the traction portion 250. Each locking portion 280 is composed of a material having elasticity, and can pass (pass over) the hole portion 270 or be locked to the hole portion 270 by elastically deforming when a tension of a prescribed value or more is imparted to the traction portion 250. Note that the shape (cross-sectional shape) of the protrusion is not particularly limited, and can be, for example, a thorn shape (a state in which a sharp shape is formed by a straight line), a sickle shape (a state in which a sharp shape is partially formed by a curved line), or a spherical shape (a state in which the traction portion 250 is knotted).

[0100] The practitioner can maintain a state in which the traction portion 250 is pulled (hereinafter referred to as a pulled state) by causing any one of the locking portions 280 provided in the traction portion 250 to be locked to the hole portion 270 when the traction portion 250 is pulled. Thus, the practitioner can also maintain a state in which the fixing portion is expanded (hereinafter referred to as an expanded state) using the locking portion 280 when the traction portion 250 is not pulled (during a period in which the operation of the operation portion 230 is not performed).

[0101] Note that the material of the traction portion 250 is not particularly limited, and only needs to be able to compress the fixing portion 220 in the axial direction X when pulled in a state of being inserted into the inner cavity L.

[0102] In the case where the pulling portion 250 is made of a biodegradable material, if the pulling portion 250 is decomposed in the living body, the strength of the pulling portion 250 is reduced. Also, the pulling force of the pulling portion 250 with respect to the main body portion 210 is lowered (the pulling state is released). Also, the fixing portion 220 is restored from the expanded state (a state in which each of the beam portions 222 is bent outward in the radial direction) to the 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. Thus, the fixing force of the medical device 200 with respect to the pancreatic parenchyma Bl is weakened, and the medical device 200 can naturally fall into the jejunum B2.

[0103] In addition, the material of the pulling portion 250 is not particularly limited, and for example, a thermoplastic elastomer such as vinyl chloride, a polyurethane elastomer, a polystyrene elastomer, a styrene-ethylene-butylene-styrene copolymer (SEBS), a styrene-ethylene-propylene-styrene copolymer (SEPS), a thermoplastic resin such as nylon, PET, or a rubber, a silicone elastomer, or the like can be used.

[0104] In addition, the cross-sectional shape and the thickness of the pulling portion 250 are not particularly limited, and it is only necessary that the anastomosis of the digestive tract is not hindered.

[0105] In addition, the pulling portion 250 can have a needle portion having biocompatibility at the other end portion opposite to the one end portion fixed to the connecting portion 260. Thus, the operator can perform suture fixation on the serosa of the jejunum B2 using the pulling portion 250, and can bring the jejunum B2 close to the pancreatic parenchyma Bl.

[0106] In addition, the locking portion 280 can be provided on the hole portion 270 side. For example, a valve body or a notch can be provided on the hole portion 270. The locking portion 280 can maintain the pulling state by sandwiching at least a part of the pulling portion 250. In the case where the locking portion 280 is a valve body provided on the hole portion 270 side, the pulling portion 250 can be configured to be able to advance and retreat by elastically deforming the locking portion 280 when a predetermined or greater tension is applied to the pulling portion 250 by the operator. In addition, in the case where the locking portion 280 is a notch (slit) provided on the hole portion 270 side, the pulling portion 250 can be configured to be able to advance and retreat by detaching the locking portion 280 from the notch when a predetermined or greater tension is applied to the pulling portion 250 by the operator.

[0107] In addition, the material of the locking portion 280 is not particularly limited, and it is only necessary that the locking portion 280 has elasticity. It is preferable that the locking portion 280 is made of a biodegradable material. If the locking portion 280 is decomposed in the living body, the pulling state is released. Thus, the fixing force of the medical device 200 with respect to the pancreatic parenchyma Bl is weakened, and the medical device 200 can naturally fall into the jejunum B2. Note that in the case where the locking portion 280 is made of a biodegradable material, the pulling portion 250 can be made of a non-biodegradable material.

[0108] The material of the locking portion 280 is not particularly limited, and for example, a thermoplastic elastomer such as chlorovinyl, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), a thermoplastic resin such as nylon, PET, or rubber, or silicone elastomer can be used.

[0109] Further, the shape of the locking portion 280 is not particularly limited as long as it can pass through the hole portion 270 of the main body portion 210 or be locked in the hole portion 270 due to elastic deformation. Further, the shapes of the respective locking portions 280 can be the same as or different from each other.

[0110] Further, as described above, the medical instrument 200 according to the present embodiment is provided with the main body portion 210, the fixing portion 220, the operation portion 230, and the auxiliary portion 240, but can be configured of the main body portion 210, the fixing portion 220, and the operation portion 230. Further, the traction portion 250 can not be integrally configured with the main body portion 210. In this case, the operator prepares the traction portion 250 separately from the medical instrument 200 at the time of surgery. The operator can appropriately combine and use the medical instrument 200 and the traction portion 250 according to the progress of surgery and the like.

[0111] As described above, the medical instrument 200 according to the present embodiment has: the main body portion 210 (tubular member) disposed between the pancreatic parenchyma Bl and the jejunum B2 (a pair of digestive tracts that are the joining objects), and provided with the lumen L; and the fixing portion 220 that generates a fixing force configured to fix the main body portion 210 to the pancreatic parenchyma Bl (at least one digestive tract), the fixing portion 220 being configured to expand the outer shape (outer diameter rl) by an external force.

[0112] According to the above-described medical instrument 200, the fixing portion 220 can expand the inner wall of the pancreatic duct Blb by expanding the outer shape (outer diameter rl) of the medical instrument 200 to increase the fitting force (resistance) of the medical instrument 200 with respect to the pancreatic parenchyma Bl. Therefore, the fixing portion 220 can fix the main body portion 210 to the pancreatic duct Blb. Therefore, when the operator once inserts the medical instrument 200 into the pancreatic duct Blb and fixes the main body portion 210 to the pancreatic duct Blb by the fixing portion 220, it is possible to maintain the state in which the medical instrument 200 is inserted into the lumen (pancreatic duct Blb) of the pancreatic parenchyma Bl. Further, the operator does not need to pull out the medical instrument 200 from the pancreatic duct Blb, and can perform needle manipulation in the vicinity of the cut surface Bla (anterior wall Bid and posterior wall B1c) of the pancreatic parenchyma Bl and the jejunum B2 to join the pancreatic parenchyma Bl and the jejunum B2. Therefore, the operator can perform anastomosis of the pancreatic parenchyma Bl and the jejunum B2 without suturing the pancreatic duct Blb and the jejunum B2, and can easily join the pancreatic parenchyma Bl and the jejunum B2.

[0113] Further, the medical instrument 200 is provided with an operation portion 230 that deforms the fixing portion 220 by transmitting an external force to the fixing portion 220. Therefore, the operator can easily join the pancreatic parenchyma B1 and the jejunum B2.

[0114] Further, the operation portion 230 is provided with a pulling portion 250 that imparts an external force to the fixing portion 220 by being pulled and compresses the fixing portion 220 along the axial direction X, and a connection portion 260 that can connect the pulling portion 250 and the main body portion 210. Therefore, the operator can deform the fixing portion 220 without directly applying an external force to the fixing portion 220.

[0115] Further, the medical instrument 200 is further provided with an auxiliary portion 240 that maintains a state in which the operation portion 230 transmits an external force to the fixing portion 220. Therefore, the operator can maintain the expanded state of the medical instrument 200 during a period in which the operation portion 230 is not operated.

[0116] Further, the auxiliary portion 240 is provided with a hole portion 270 (a through hole) that is formed in the main body portion 210, is disposed at the base end side (a central side compared to the fixing portion 220 formed at the tip end side of the main body portion 210 (an end portion of the axial direction X)) compared to the fixing portion 220 formed at the tip end side of the main body portion 210, exposes the pulling portion 250 to the outside in a state in which the pulling portion 250 is inserted into the lumen L, and a locking portion 280 that is provided to at least one of the pulling portion 250 and the hole portion 270 and is configured to be able to lock at least a part of the pulling portion 250 to the hole portion 270. Therefore, the operator can maintain the pulled state by locking any one of the locking portions 280 provided to the pulling portion 250 to the hole portion 270 of the main body portion 210 when pulling the pulling portion 250. Therefore, the operator can maintain the expanded state of the medical instrument 200 using the locking portion 280.

[0117] Further, the fixing portion 220 has a plurality of hole portions 221 provided at the tip end side (an end portion of the axial direction X) of the main body portion 210 and a plurality of beam portions 222 disposed between the hole portions 221, and expands the outer diameter r1 by bending each of the beam portions 222 outward in the radial direction when the fixing portion 220 is compressed along the axial direction X due to the pulling portion 250. By expanding the outer shape (the outer diameter r1) of the medical instrument 200, it is possible to expand the inner wall of the pancreatic duct B1b to increase the fitting force (resistance) of the medical instrument 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.

[0118] Further, the medical instrument set has the medical instrument 200 described above and the healing promotion sheet 100 that promotes healing of the pancreatic parenchyma Bl and the jejunum B2 by being disposed between the pancreatic parenchyma Bl and the jejunum B2. By being configured in this way, in a procedure in which a pair of digestive tracts are joined, it is possible to reduce the risk of postoperative incomplete suturing and to inhibit leakage of pancreatic juice from the pancreatic duct Blb during the procedure and to simply join the pancreatic parenchyma Bl and the jejunum B2.

[0119] Next, variations 1 to 3 of the medical instrument 200 according to the first embodiment will be described. Note that, in the description of the variations 1 to 3, the same reference signs are assigned to the components common to the medical instrument 200 described above and the description thereof will be appropriately omitted. Further, as for the contents not specifically described in the description of the variations, the same contents as those of the preceding embodiment can be assumed.

[0120] <Variation 1>

[0121] Figure 13 、 Figure 14 is a view for explaining the medical instrument 300 according to the variation 1.

[0122] The medical instrument 300 has a main body portion 210 disposed between digestive tracts (the pancreatic parenchyma Bl and the jejunum B2) to be joined, a fixing portion 320 that generates a fixing force for configuring the main body portion 210 to be fixed to at least one of the digestive tracts (the pancreatic parenchyma Bl), and an operation portion 330 that deforms the fixing portion 320 by transmitting an external force to the fixing portion 320.

[0123] As shown in Figure 13 , the fixing portion 320 according to the variation 1 can also be configured by a plurality of hole portions 321 provided at a certain region of the front end side of the main body portion 210 and a plurality of wire members 322 that are partially housed inside the main body portion 210 and can protrude from each of the hole portions 321 when compressed in the axial direction X by an external force.

[0124] Further, the operation portion 330 according to the variation 1 can also be configured by a base end side of the wire member 322 provided in a manner protruding toward the base end side of the main body portion 210 and capable of being pushed in toward the front end side of the main body portion 210.

[0125] The front end side of the wire member 322 according to the variation 1 is housed in a recess portion provided between the inner peripheral wall and the outer peripheral wall of the main body portion 210. Further, the base end side of the wire member 322 is provided in a manner protruding toward the base end side of the main body portion 210. Further, the recess portion communicates with the hole portion 321. Therefore, the wire member 322 is inserted in the main body portion 210 in a manner partially following the hole portion 321.

[0126] When the operator performs the operation of the operating unit 330 (pushing the wire 322, which protrudes towards the base end of the main body 210, towards the front end), such as Figure 14 As shown, the wire 322 is compressed along the axial direction X and bent outward in the radial direction. Furthermore, the bent portion of the wire 322 protrudes from the hole 321. In this way, the operator can expand the shape (outer diameter) of the medical device 300 into a circular shape (radial) by applying external force to the wire 322.

[0127] The operator can adjust the fixation force of the medical device 300 relative to the digestive tract by adjusting the length of the orifice 321 and the length of the wire 322 to change the outer diameter of the fixed part 320 after expansion and the shape of the wire 322 after deformation.

[0128] The wire 322 is preferably made of a biodegradable alloy with elastic-plastic or shape-retention properties, for example, it can be made of Mg or an alloy with Mg as the main component. Because of its elastic-plastic or shape-retention properties, the wire 322 can maintain its shape after deformation under external force. Therefore, the medical device 300 can maintain its expanded state. Furthermore, because the wire 322 is biodegradable, its strength decreases if it decomposes within the body. Therefore, if the medical device 300 is left in the body for a predetermined period, it can release its expanded state and naturally detach into the jejunum B2.

[0129] <Variation Example 2>

[0130] Figure 15 , Figure 16 This is a diagram used to illustrate the medical device 400 involved in Variation Example 2.

[0131] The medical device 400 includes: a main body 210 disposed between a digestive tract (pancreatic parenchyma B1 and jejunum B2) that is to be joined; a fixing part 420 that generates a fixing force to fix the main body 210 to at least one digestive tract (pancreatic parenchyma B1); and an operating part 430 that deforms the fixing part 420 by transmitting an external force to the fixing part 420.

[0132] like Figure 15 As shown, the fixing part 420 involved in Modification Example 2 can also be composed of a wire 421, which is connected to the operation part 430 and the front end side of the main body part 210 described later, and is configured to be spirally wound around the main body part 210.

[0133] Alternatively, the operating part 430 involved in Modification Example 2 can also be composed of a gripping part, which is provided on the base end side of the main body part 210 and configured to be able to rotate along the circumferential direction θ of the main body part 210.

[0134] When the operator operates the operation portion 430 (rotates to the side opposite to the winding direction of the wire 421), as shown in FIG. 4B, the winding diameter of the wire 421 is expanded. Thus, the operator can expand the outer shape (outer diameter) of the medical instrument 400 by imparting an external force to the wire 421. Figure 16

[0135] The operator can change the outer diameter of the fixed portion 420 after the expansion and adjust the fixing force of the medical instrument 400 with respect to the digestive tract by adjusting the operation amount of the operation portion 430.

[0136] The wire 421 can be composed of the same material as the wire 322 of the modified example 1.

[0137] In addition, the cross-sectional shape of the wire 421 is not particularly limited. A protrusion can be provided locally in the wire 421, and the wire 421 can further improve the fitting force (resistance) with respect to the pancreatic parenchyma B1 through the protrusion.

[0138] Note that the form of the connection portion of the operation portion 430 and the main body portion 210 is not particularly limited. For example, the operation portion 430 can be partially inserted into the lumen L of the main body portion 210. In addition, the connection method of the operation portion 430 and the main body portion 210 is not particularly limited, and for example, the main body portion 210 and the operation portion 430 can be connected by providing a protrusion or the like in the lumen L of the main body portion 210. The protrusion can be composed of the same material as the main body portion 210 or a different material, and for example, can be composed of a material having biodegradability, a material having water solubility. By being composed in this way, the lumen L of the main body portion 210 is expanded when the protrusion is decomposed in the living body. Thus, the discharge path of the pancreatic juice from the pancreatic duct B1b to the jejunum B2 can be further ensured.

[0139] <Modified Example 3>

[0140] Figure 17 Figure 18 is a view for explaining the medical instrument 500 involved in the modified example 3.

[0141] The medical instrument 500 has a main body portion 510 disposed between the digestive tracts (the pancreatic parenchyma B1 and the jejunum B2) to be joined, a fixed portion 520 that generates a fixing force for configuring the main body portion 510 to be fixed to at least one of the digestive tracts (the pancreatic parenchyma B1), and an operation portion 530 that deforms the fixed portion 520 by transmitting an external force to the fixed portion 520.

[0142] The main body portion 510 of the modified example 3 is preferably an alloy having biodegradability and having elasto-plasticity or shape memory, and can be composed of, for example, Mg or an alloy in which Mg is a main component.

[0143] As shown in FIG. 5B, the fixed portion 520 is deformed by the operation portion 530, and the outer diameter of the fixed portion 520 is expanded. Thus, the operator can expand the outer shape (outer diameter) of the medical instrument 500 by imparting an external force to the operation portion 530.​​Figure 17 As shown, the fixed portion 520 according to the modification 3 can also be configured by a plurality of hole portions 521 provided in a certain region of the leading end side of the main body portion 510 and a plurality of beam portions 522 respectively arranged between the hole portions 521.

[0144] The operation portion 530 according to the modification 3 can also be configured by using a certain region of the base end side of the main body portion 510 as a gripping portion.

[0145] When the operator operates the operation portion 530 (twists the base end side of the main body portion 510), as shown in FIG. 6B, the fixed portion 520 is deformed into a spiral shape, and the beam portions 522 are bent outward in the radial direction. In this way, the operator can expand the outer shape (outer diameter) of the medical instrument 500 by imparting an external force to the fixed portion 520. Figure 18

[0146] The operator can change the outer diameter of the fixed portion 320 after the expansion, the outer shape when viewed from the axis X, and the fixing force of the medical instrument 200 with respect to the digestive tract by adjusting the length and the inclination angle of the hole portion 321.

[0147] <Embodiment of Treatment Method (Anastomosis of Biological Organs)>

[0148] Next, a treatment method using the medical instrument kit will be described.

[0149] Figure 19 is a flowchart showing each step of the treatment method using the medical instrument kit.

[0150] The treatment method includes the steps of: arranging the medical instrument between one to be joined site and another to be joined site of biological organs to be joined (S11); inserting the medical instrument into a healing promoting sheet having a sheet-shaped main body portion that promotes healing of biological tissue, fixing the medical instrument to one to be joined site (S12); and joining one to be joined site and another to be joined site in a state where at least a part of the main body portion of the healing promoting sheet is arranged between one to be joined site and another to be joined site (S13).

[0151] The biological organs and the to be joined sites in the biological organs to be joined by the treatment method are not particularly limited and can be arbitrarily selected. In the following description, pancreatic parenchymal-jejunum anastomosis will be described as an example. In addition, as the medical instrument kit used in each of the following surgeries, for example, any of the medical instrument kits described above can be selected, and another medical instrument kit can also be selected. Among them, in the following description, as a representative example that can be appropriately used in each of the surgeries, the medical instrument kit according to the modification 1 will be described. Figure 1 ​An example of use of the medical instrument set is shown. In addition, in each of the operations described below, detailed description is appropriately omitted for known operation steps, known medical devices, medical instruments, and the like.

[0152] Hereinafter, in the description of the present specification, the so-called "arranging the healing-promoting sheet (or the medical instrument) between the biological organs" means at least one of the operation of arranging the healing-promoting sheet (or the medical instrument) in a state of directly or indirectly contacting the biological organs, the operation of arranging the healing-promoting sheet (or the medical instrument) in a state of forming a spatial gap between the biological organs, or the operation of arranging the healing-promoting sheet (or the medical instrument) in both of the above states (for example, the operation of arranging in a state where one biological organ contacts the healing-promoting sheet (or the medical instrument) and the healing-promoting sheet (or the medical instrument) does not contact the other biological organ). In addition, in the description of the present specification, the "periphery" is not limited to a strict range (region) as long as the treatment purpose (engagement of the biological organs with each other) can be achieved. In addition, the operation steps described in each treatment method can be appropriately exchanged in order as long as the treatment purpose can be achieved. In addition, in the description of the present specification, the so-called "bringing into relative proximity" means both of bringing two or more objects to be brought into proximity with each other and bringing only one into proximity with the other.

[0153] <Embodiment of Treatment Method (Pancreatic Parenchyma-jejunum Anastomosis)>

[0154] Figures 20 is a flowchart showing steps of the embodiment of the treatment method (pancreatic parenchyma-jejunum anastomosis), Figures 21 to 26 is a diagram for explaining the pancreatic parenchyma-jejunum anastomosis.

[0155] In the treatment method related to the present embodiment, the biological organs to be engaged are the pancreatic parenchyma B1 after the pancreatoduodenectomy and the jejunum B2. In the following description, the step of engaging the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 (one engagement site) with an arbitrary portion of the intestinal wall of the jejunum B2 (the other engagement site) is described.

[0156] As shown in Figure 20 , the treatment method related to the present embodiment includes the steps of preparing a medical instrument set having the healing-promoting sheet 100 and the medical instrument 200 (S101), inserting the medical instrument 200 into the pancreatic duct B1b (S102), mounting the healing-promoting 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).

[0157] Next, the operation of the medical instrument set will be described with reference to Figures 21 to 26, a specific example of the treatment method involved in the present embodiment will be described. Note that in Figure 26 the following, a plurality of two-end needles 920a to 920e described later are omitted.

[0158] First, the operator prepares a medical instrument set having the healing-promoting sheet 100 and the medical instrument 200 (S101).

[0159] Next, as shown in Figure 21 , the operator inserts the medical instrument 200 into the pancreatic duct B1b from the front end side of the main body portion 210 (the side of the front end side opening portion 210A shown in Figure 1 ). Then, the operator can fix the medical instrument 200 to the pancreatic parenchyma B1 (S102). At this time, the operator can expand the outer shape (outer diameter r1) of the fixing portion 220 by compressing the fixing portion 220 in the axial direction X by pulling the pulling portion 250 (see Figure 22 ). In addition, the operator can maintain the pulling force of the pulling portion 250 with respect to the main body portion 210 by causing the locking portion 280 formed in the pulling portion 250 to be locked to the hole portion 270 of the main body portion 210. Thus, the operator can fix the position of the medical instrument 200 with respect to the pancreatic duct B1b using the fixing portion 220.

[0160] Next, as shown in Figure 23 , the operator forms the hole portion 120 in the healing-promoting sheet 100 (see Figure 1 ) and attaches it to the medical instrument 200 (S103). Note that the instrument used by the operator when forming the hole portion 120 is not particularly limited. In addition, the hole portion 120 can be formed in the healing-promoting sheet 100 in advance in a state before use. In addition, the operator can insert the medical instrument 200 into the pancreatic duct B1b after threading the medical instrument 200 through the hole portion 120 of the healing-promoting sheet 100.

[0161] Next, the operator inserts the base end side of the main body portion 210 (the side of the base end side opening portion 210B shown in Figure 1 ) into the jejunum B2 (S104). Thereby, an outflow path that outflows pancreatic juice from the pancreatic duct B1b to the jejunum B2 is formed (see Figure 26 ), and leakage of pancreatic juice from the pancreatic duct B1b to the joined portion of the pancreatic parenchyma B1 and the jejunum B2 can be suppressed.

[0162] Next, as shown in Figure 24As shown, the operator arranges the healing-promoting sheet 100 on the cut surface B1a of the pancreatic parenchyma B1 and sutures the pancreatic parenchyma B1 to the jejunum B2 (S105). Note that in the following description, an example of a step in which the plurality of two-end needles 920a to 920e are used as fixing members and the healing-promoting sheet 100 is fixed to the pancreatic parenchyma B1 will be described. As the two-end needles 920a to 920e, a known configuration having an absorbable thread (suture thread) having biocompatibility and a needle portion having biocompatibility attached to both ends of the absorbable thread can be used.

[0163] First, the operator performs needle threading of the two-end needle 920a from the rear wall B1c (a portion on the dorsal side of the circumference of the pancreatic parenchyma B1) of the pancreatic parenchyma B1 and a portion of the healing-promoting sheet 100 arranged on the rear wall B1c toward the front wall B1d (a portion on the ventral side of the circumference of the pancreatic parenchyma B1) of the pancreatic parenchyma B1 and a portion of the healing-promoting sheet 100 arranged on the front wall B1d.

[0164] Next, the operator performs needle threading of the two-end needle 920a in such a manner that the two-end needle 920a penetrates the jejunum serous muscular layer of the anastomosis intended portion (a periphery of the penetration hole B2a formed in the jejunum B2) of the jejunum B2. The operator repeatedly performs such an operation so that the plurality of two-end needles 920a to 920e penetrate the healing-promoting sheet 100, the pancreatic parenchyma B1, and the jejunum serous muscular layer of the jejunum B2. In this way, the operator can fix the healing-promoting sheet 100 to the pancreatic parenchyma B1 using the plurality of two-end needles 920a to 920e that suture the pancreatic parenchyma B1 to the jejunum B2.

[0165] Note that the number of two-end needles that penetrate the pancreatic parenchyma B1 and the jejunum serous muscular layer of the jejunum B2 and the positions at which the two-end needles penetrate are not particularly limited. In addition, the operator can fix the healing-promoting sheet 100 to the pancreatic parenchyma B1 using biodegradable anastomosis staples or the like instead of the plurality of two-end needles 920a to 920e as fixing members.

[0166] Next, as shown in Figure 25 , the operator ligates the two-end needles 920a to 920e while pressing the jejunum B2 against the pancreatic parenchyma B1 with a finger. Thereby, the pancreatic parenchyma B1 and the jejunum B2 are sutured in a state in which the healing-promoting sheet 100 is sandwiched (see Figure 26 ). The jejunum B2 is deformed in such a manner that the cut surface B1a of the pancreatic parenchyma B1 and the main body portion 110 of the healing-promoting sheet 100 are wrapped by the jejunum B2 due to tension generated at the time of suturing.

[0167] The operator can leave the main body 110 of the healing-promoting sheet 100 between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 by the above operation. In addition, the operator can leave the medical instrument 200 between the pancreatic parenchyma B1 and the jejunum B2 as a so-called internal fistula tube. The main body 110 of the healing-promoting sheet 100 promotes healing of the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2 by being in contact with the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 and being left between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. In addition, the medical instrument 200 naturally falls into the jejunum B2 and is led outside the body after the operator performs anastomosis of the biological organs and a prescribed period (several weeks to several months) elapses.

[0168] As described above, the treatment method of the present embodiment is applied to a surgery of joining the pancreatic parenchyma B1 and the jejunum B2. In addition, in the above treatment method, the cut surface B1a of the cut pancreatic parenchyma B1 is joined to the intestinal wall (the jejunum serous muscle layer) of the jejunum B2. According to this treatment method, it is possible to promote healing of the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2 using the main body 110 of the healing-promoting sheet 100 interposed between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2, and it is possible to reduce the risk of incomplete suture after pancreatic-jejunum anastomosis.

[0169] Note that the present application is not limited to the above-described embodiments, and various modifications can be made within the scope of the application. For example, the above describes a case where the healing-promoting sheet and the medical instrument are separate, but they can be integrated.

[0170] In addition, the above describes an embodiment of the medical instrument in which the fixing portion is arranged on one side in the axial direction X of the main body. However, as long as the fixing portion is easily caught in the shape of the biological lumen where the medical instrument is arranged, the fixing portion 220 can be arranged on both sides in the axial direction X of the main body 210 as shown in FIG. 12B. Figure 27 By providing the fixing portions 220 on both sides of the medical instrument 200A like this, it is possible to expect an increase in the fixing force of the medical instrument with respect to the biological organ (see FIG. 12C). Figure 28 Note that the respective pulling portions 250 for pulling the fixing portions 220 arranged on both sides of the main body 210 can be connected to each other. By doing so, the operator can operate the fixing portions 220 arranged on both sides of the main body 210 at a time.

[0171] Furthermore, the above description describes a medical device with one fixing part on one side of the main body along the axial direction X. However, multiple fixing parts may also be provided at one end of the medical device. In this case, it is preferable that the distance between one fixing part and other fixing parts is greater than the height of the beam portion that extends radially from the outer peripheral surface of the main body when the medical device is in an expanded state (see reference). Figure 4 The t1 shown is narrow. This reduces the possibility of the fixation parts being repelled by the inner wall of the digestive tract and tilting radially inward. Therefore, with fixation parts configured in this way, it is possible to prevent the fixation force of the medical device relative to the digestive tract from decreasing during surgery.

[0172] Furthermore, when multiple fixing parts are provided at one end of the medical device, when an external force is applied to the main body by the traction part, the main body may bend into a W-shape when viewed from a direction orthogonal to the axial direction X, starting from each fixing part. With fixing parts arranged in this way, the shape of the medical device can be expanded, and it is expected that the fixation force of the medical device relative to the digestive tract can be further ensured.

[0173] Furthermore, when multiple fixing parts are provided at one end of the medical device, a tubular component (hereinafter referred to as the internal tube) may be further provided within the cavity of the main body. Regarding the internal tube, when an external force is applied by the traction part, it prevents the main body from bending into a W-shape when viewed from a direction orthogonal to the axial direction X, facilitating the passage of pancreatic fluid through the cavity of the main body. Additionally, the internal tube assists the fixing parts in uniformly transmitting the external force to the multiple beams when an external force is applied by the traction part. Therefore, the internal tube allows the fixing parts to expand uniformly to maintain the fixation force of the medical device.

[0174] Note that 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 portion. In addition, the material constituting the inner tube is not particularly limited as long as it is harder than the material constituting the main body portion or the fixing portion. In addition, the length of the inner tube with respect to the axial direction X is not particularly limited, and it is preferable that the proximal end side end portion of the inner tube be disposed closer to the proximal end side than one fixing portion (the proximal end side fixing portion) disposed on the proximal end side of the main body portion, and that the distal end side end portion of the inner tube be disposed closer to the distal end side than the other fixing portion (the distal end side fixing portion) disposed closer to the distal end side than one fixing portion. Therefore, it is preferable that the inner tube extend from the connection portion to the hole portion, and it is more preferable that the inner tube extend from the connection portion to the distal end side fixing portion. In addition, the method of connecting the inner tube to the main body portion and the position of connection are not particularly limited, and the inner tube can be connected to the main body portion by the connection portion. In addition, in the case where the inner tube is not connected to the main body portion, a lubricating coating such as silicone oil can be applied to the inner surface of the main body portion and the outer surface of the inner tube. In this case, the lubricity of the inner tube with respect to the main body portion is improved, and the inner tube can move more smoothly in the inner cavity of the main body portion. Therefore, the force required when the operator pulls the pulling portion can be reduced. Note that the material that imparts the sliding property to the inner surface of the main body portion and the outer surface of the inner tube is not limited to the aforementioned lubricating coating, and can be constituted by a combination of materials having a small coefficient of friction.

[0175] In addition, the above describes an embodiment in which the main body portion is disposed so as to function as an internal fistula tube. However, the main body portion can also be disposed so as to function as an external fistula tube. In this case, the main body portion is disposed from the inside of the body to the outside of the body in a manner that penetrates the pancreatic parenchyma, the jejunum, and the skin. Furthermore, the main body portion can drain pancreatic juice to the outside of the body by connecting the end portion on the outside of the body to a drainage bag. After a prescribed period of time, the main body portion is led to the outside of the body by being pulled by the operator.

[0176] This application is based on Japanese Patent Application No. 2020-60482 filed on March 30, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0177] Explanation of Reference Signs

[0178] 1 medical device set,

[0179] 100 healing promotion sheet,

[0180] 200 medical device,

[0181] 210 main body portion (tubular member),

[0182] 220 fixing portion,

[0183] 221 hole portion,

[0184] 222 beam portion,

[0185] 230 operation portion,

[0186] 240 auxiliary portion,

[0187] 250 traction portion,

[0188] 260 connecting portion,

[0189] 270 hole portion (insertion hole),

[0190] 280 locking portion.

Claims

1. A medical instrument having: a tubular member configured between a pair of digestive tracts to be joined, and provided with a lumen; a fixing portion generating a fixing force configured to fix the tubular member to at least one of the digestive tracts, the fixing portion being capable of expanding an outer shape by an external force; an operation portion deforming the fixing portion by transmitting the external force to the fixing portion; and an assisting portion maintaining a state in which the operation portion transmits the external force to the fixing portion, the operation portion being provided with: a pulling portion imparting the external force to the fixing portion by being pulled to compress the fixing portion in an axial direction; and a connecting portion capable of connecting the pulling portion to the tubular member, the assisting portion being provided with an insertion hole formed in the tubular member, configured on a central side compared to the fixing portion formed at an end portion in the axial direction of the tubular member, and exposing the pulling portion to the outside in a state in which the pulling portion is inserted into the lumen. the assisting portion being provided with a locking portion provided to at least one of the pulling portion and the insertion hole, configured to lock at least a part of the pulling portion to the insertion hole. the fixing portion being provided with: a plurality of hole portions provided at the end portion in the axial direction of the tubular member; and a plurality of beam portions respectively configured between the hole portions, the fixing portion expanding the outer shape by bending each of the beam portions outward in a radial direction when compressed in the axial direction by the pulling portion.

4. A medical instrument kit having: the medical instrument according to any one of claims 1 to 3; and a healing promoting sheet promoting healing of the pair of digestive tracts by being configured between the pair of digestive tracts. ​ ​ ​ ​ 2. The medical instrument of claim 1, wherein, ​ 3. The medical device of claim 1 or 2, wherein, ​ ​ ​ ​

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