WO2021060361A1

WO2021060361A1 - Fusion promotion device

Info

Publication number: WO2021060361A1
Application number: PCT/JP2020/035988
Authority: WO
Inventors: 直希荒巻; 美穂甲斐; 美利亜鈴木
Original assignee: テルモ株式会社
Priority date: 2019-09-25
Filing date: 2020-09-24
Publication date: 2021-04-01
Also published as: JPWO2021060361A1; JP7498188B2

Abstract

In order to provide a fusion promotion device whereby the risk of sutural insufficiency after a surgical operation or the like can be reduced, the present invention is configured so as to have: a body part (10) for promoting fusion of a biological tissue when a first part to be joined in the biological tissue and a second part to be joined which faces the first part to be joined are joined by a medical instrument (200) comprising a mating instrument (210, 270) which joins the first part to be joined and the second part to be joined and to which can be attached a first magnetic part (310) which includes a magnetic material and which can come in contact with the first part to be joined or the second part to be joined; and a second magnetic part (20) which is provided in a position facing the first magnetic part in the surface direction of the body part when the body part is arranged between the first part to be joined and the second part to be joined, and the mating instrument is placed in contact with the first part to be joined or the second part to be joined, and which is capable of adhering to the first magnetic part by a magnetic force received from the first magnetic part.

Description

Healing promotion device

The present invention relates to a fusion promoting device.

In the medical field, a technique of surgically joining biological organs (for example, gastrointestinal anastomosis) is known. It is known that when the above-mentioned procedure is performed, it is important as a postoperative prognosis determinant that there is no delay in fusion at the joint where the biological organs are joined.

Various methods and medical instruments are used in the technique of joining living organs. For example, a method of suturing a living organ with a biodegradable suture or a mechanical anastomosis device for anastomosis with a stapler (see Patent Document 1). The method of using is proposed. In particular, when anastomosis is performed using a mechanical anastomosis device, the joint force between biological organs at the joint can be increased as compared with the method using sutures, which reduces the risk of suture failure. Will be possible.

Special Table 2007-505708 Gazette

However, the degree of progression of fusion at the junction also depends on the condition of the biological tissue at the junction target site (joint site) of the patient. Therefore, for example, even when a joining device as described in Patent Document 1 is used, the risk of suture failure may not be sufficiently reduced depending on the condition of the patient's living tissue.

Therefore, an object of the present invention is to provide a fusion promoting device capable of reducing the risk of suture failure after surgery or the like.

The fusion promoting device according to the present invention joins a first joined portion in a living tissue and a second joined portion facing the first joined portion, and joins the first joined portion or the second joined portion. When the first bonded portion and the second bonded portion are joined by a medical device provided with an engaging device capable of contacting with and to which a first magnetic portion containing a magnetic material can be attached, a biological tissue is formed. The main body portion that promotes the fusion of the above and the main body portion are arranged between the first joined portion and the second joined portion, and the engaging device is placed at the first joined portion or the second joined portion. A second magnetic portion that is provided at a position facing the first magnetic portion in the surface direction of the main body portion and can be brought into close contact with the first magnetic portion by the magnetic force received from the first magnetic portion. And have.

According to the fusion promoting device according to the present invention, the risk of suture failure after surgery or the like can be reduced.

It is a schematic perspective view which shows the fusion promotion device and the medical device which concerns on 1st Embodiment of this invention. FIG. 3 is a perspective view showing a tip of a first engaging instrument and a second engaging instrument constituting the medical device according to FIG. 1. It is a perspective view which shows the state which the fusion promotion device is inserted through the shaft of the 2nd engaging device which constitutes a medical device. It is a side view of FIG. It is sectional drawing which shows the through hole in the fusion promotion device of FIG. It is a flowchart which shows each procedure of the treatment method using a fusion promotion device. It is a flowchart which shows the procedure of embodiment (colon anastomosis) of a treatment method. It is a schematic cross-sectional perspective view for demonstrating colorectal anastomosis. It is a schematic cross-sectional view for demonstrating colorectal anastomosis. It is a schematic cross-sectional view for demonstrating colorectal anastomosis. It is a schematic cross-sectional view for demonstrating colorectal anastomosis. It is a side view which shows the 2nd engaging device and the fusion promotion device of the medical device which concerns on the modification of 1st Embodiment. It is a schematic perspective view which shows the 2nd engaging device, the reinforcing member, and the fusion promotion device of the medical device which concerns on 2nd Embodiment. It is a schematic perspective view which shows the state which attached the attachment part (outer peripheral piece) of the reinforcing member to the 2nd engaging apparatus from the state shown in FIG.

Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. In the description of the drawings, the same elements are designated by the same reference numerals, and duplicate description will be omitted. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios.

<First Embodiment>
1 to 4 are diagrams provided for explaining the fusion promoting device 100 and the medical device 200 according to the first embodiment of the present invention. FIG. 5 is a cross-sectional view showing a through hole 11 of the fusion promoting device 100. 6 to 11 are views for explaining the case of performing gastrointestinal anastomosis using the large intestine as an example using the fusion promoting device 100. In the present embodiment, the fusion promoting device 100 and the medical device 200 can be collectively referred to as a medical device set.

The fusion promoting device 100 can be applied to a procedure for joining predetermined biological organs (for example, gastrointestinal anastomosis) as shown in FIGS. 8 to 11. As will be described later, in the description of the present specification, the large intestine anastomosis technique will be described as an example of the procedure using the fusion promoting device 100, but the site where the fusion promoting device according to the present invention can be used is not limited to the large intestine.

The fusion promoting device 100 is used when the first jointed portion such as the large intestine and the second joined portion are joined by the medical device 200. In explaining the fusion promoting device 100, the medical device 200 will be described.

<Medical equipment>
The medical device 200 joins a first joined portion in a living tissue and a second joined portion facing the first joined portion. The medical device 200 includes a first engaging device 210 and a second engaging device 270 capable of sandwiching the main body portion 10 through the first joined portion and the second joined portion. The first engaging instrument 210 can be brought into contact with the first joined portion, and the second engaging instrument 270 is configured to be able to come into contact with the second joined portion. Details will be described later. The first engaging device 210 may be referred to as a trocar and the second engaging device 270 may be referred to as an anvil.

<First engaging device>
The first engaging device 210 includes a long member 220, a positioning unit 230, a discharging unit 240, a punching unit 250, and an operating unit 260.

The long member 220 corresponds to the main body of the first engaging device 210. As shown in FIG. 2, the long member 220 includes a space S in which the shaft of the positioning portion 230 can be relatively moved back and forth at the tip in the longitudinal direction. In the present specification, the longitudinal direction at the tip of the long member 220 is defined as the direction X. The long member 220 has a hollow circular cross section intersecting the direction X. In the present embodiment, the long member 220 extends linearly in the longitudinal direction and has a bent portion. However, if the anastomosis function and the punching function described later can be realized, the long member does not have a bent portion. May be good.

The positioning unit 230 includes a long shaft. As shown in FIG. 2, the shaft of the positioning portion 230 is configured to be relatively movable back and forth from the space S at the tip of the long member 220 in the longitudinal direction.

The discharge unit 240 is configured to be capable of releasing a plurality of staples that join the first bonded portion and the second bonded portion. The discharge portion 240 is formed in a substantially disk shape on the tip end side in the longitudinal direction of the long member 220. The discharge unit 240 is configured by providing a plurality of staple discharge points along the circumferential direction θ at the tip of the long member 220. In the present specification, the plane direction intersecting the longitudinal direction at the tip of the long member 220 is defined as the direction YZ, the radial direction or the radial direction is defined as the radial direction r, and the circumferential direction or the angular direction is defined as the circumferential direction θ.

The punching portion 250 is arranged at the tip of the long member 220 inward in the radial direction r than the discharging portion 240, and is configured to punch inward in the radial direction of the first bonded portion and the second bonded portion. There is. As shown in FIG. 2, the punching portion 250 is configured to include an annular blade that punches out the first bonded portion and the second bonded portion inward in the radial direction r than the discharging portion 240.

The operation unit 260 is configured so that the positioning unit 230, the discharge unit 240, and the punching unit 250 can be operated. The operation unit 260 includes a rotating unit 261 and a handle 262.

The rotating portion 261 is provided at the proximal end portion (base end side) of the long member 220 in the longitudinal direction. The rotating portion 261 is configured to be rotatable with respect to the long member 220 with the longitudinal direction on the base end side of the long member 220 as the rotation axis. In a state where the second engaging tool 270 is engaged with the first engaging tool 210, the rotating portion 261 is rotated with respect to the long member 220 to form the first engaging tool 210 and the second engaging tool 270. Is configured so that they can be relatively close and separated.

The handle 262 is configured to be grippable by the user together with the base end portion (base end side) of the long member 220. The handle 262 is rotatably connected to the elongated member 220 by a rotating shaft 263. The handle 262 rotates around the rotating shaft 263 and comes relatively close to the elongated member 220 when gripped by the user. As a result, the staples are discharged from the discharging portion 240, and the annular blade of the punching portion 250 can be projected from the tip of the long member 220.

<Second engaging device>
The second engaging device 270 is configured so that the main body 10 of the fusion promoting device 100 can be sandwiched between the first joined portion and the second joined portion. As shown in FIG. 3, the second engaging device 270 includes a head 280, a contact portion 290, a first magnetic portion 310, and a shaft 320.

The head 280 is arranged adjacent to the long member 220 of the first engaging device 210, particularly on the tip end side, when the first engaging device 210 and the second engaging device 270 are engaged with each other. In the present embodiment, the head 280 is configured to have a substantially disk shape as shown in FIGS. 2 and 3, and the cross-sectional shape is configured to be the same as or similar to the circular shape of the long member 220.

The contact portion 290 is configured to be able to contact a plurality of staples discharged from the discharge portion 240. The contact portion 290 is provided on the side of the first engaging device 210 in the axial direction of the head 280 (the plate thickness direction, see the direction X in FIG. 3). The contact portion 290 is configured so as to be able to contact a plurality of staples discharged from the discharge portion 240. The staples released from the discharging portion 240 are brought into contact with each other at the contacting portion 290 and deformed to join the first bonded portion and the second bonded portion.

The first magnetic portion 310 is configured to be attracted by a magnetic force to the second magnetic portion 20 provided in the main body portion 10 of the fusion promoting device 100. As a result, the first magnetic portion 310 and the second magnetic portion 20 are configured to be in close contact with each other. In the present embodiment, the first magnetic portion 310 is configured to be attached to the head 280 and integrated with the head 280 on the side of the contact portion 290, which is the side of the first engaging device 210 in the plate thickness direction (direction X) of the head 280. are doing. The first magnetic portion 310 is formed in a disk shape so that the outer diameter d1 of the first magnetic portion 310 is smaller than the inner diameter d2 of the contact portion 290. The first magnetic portion 310 includes a magnetic material such as a hard magnetic material constituting a permanent magnet. The magnetic material is not particularly limited, and examples thereof include iron, cobalt, nickel, samarium, and neodymium.

The shaft 320 is provided to engage the first engaging device 210 and the second engaging device 270. The shaft 320 is configured to extend axially from the side of the first engaging device 210 in the axial direction (direction X) of the head 280. The shaft 320 has a circular cross section perpendicular to the longitudinal direction in the present embodiment. The shaft 320 is provided with a space for accommodating the shaft of the positioning portion 230 of the first engaging device 210. The shaft 320 is configured to fit the shaft of the positioning portion 230, which enables the alignment of the first engaging instrument 210 and the second engaging instrument 270.

<Union promotion device>
As shown in FIG. 3, the fusion promoting device 100 includes a main body portion 10, a second magnetic portion 20, a reinforcing portion 30, and a hole portion 40.

<Main body>
The main body portion 10 promotes fusion of the living tissue when joining the first joined portion in the living tissue and the second joining site facing the first joined site.

The main body 10 includes a plurality of through holes 11 formed so as to be inserted in the thickness direction (direction X) as shown in FIGS. 3 and 5. For example, the size of the through hole 11 of the main body 10 is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm. The main body 10 can be configured such that the ratio of the dimension D of the through hole 11 to the pitch P is 0.2 or more and less than 40.

The main body 10 can be made of a biodegradable material. The constituent material of the main body 10 is not particularly limited, and examples thereof include biodegradable resins.

Specifically, it is selected from the group consisting of (1) aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. Polymer; (2) A copolymer composed of one or more monomers constituting the above (1) and the like can be mentioned.

That is, the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and celluloses. It preferably contains at least one biodegradable resin selected from the group consisting of a polymer and a copolymer composed of one or more monomers constituting the polymer.

When the main body portion 10 is arranged between the first bonded portion and the second bonded portion and the medical instrument 200 is brought into contact with the first bonded portion and the second bonded portion, the second magnetic portion 20 is brought into contact with the first bonded portion and the second bonded portion. It is provided at a position facing the first magnetic portion 310 in the surface direction (direction YZ) of the main body portion 10. The second magnetic portion 20 is configured to be in close contact with the first magnetic portion 310 by the magnetic force received from the first magnetic portion 310. The second magnetic portion 20 is formed in a flat substantially disk shape in the present embodiment.

The second magnetic portion 20 is configured to include a soft magnetic material such as iron that can be magnetized by the first magnetic portion 310 including a permanent magnet in the present embodiment. However, in addition to the above, the first magnetic part 310 may be made of a soft magnetic material and the second magnetic part 20 may be made of a hard magnetic material as long as the first magnetic part 310 and the second magnetic part 20 can be brought into close contact with each other. In addition to the above, both the first magnetic portion 310 and the second magnetic portion 20 may be made of a hard magnetic material such as a permanent magnet.

The reinforcing portion 30 is provided to prevent the fusion promoting device 100 from being damaged when the fusion promoting device 100 is placed between the first bonded portion and the second bonded portion by the medical device 200. In the present embodiment, the reinforcing portion 30 is configured such that the through hole 11 like the main body portion 10 is not provided on the outer circumference of the hollow substantially circular shape. However, as long as the strength of the fusion promoting device 100 can be improved, the specific shape and arrangement are not limited to the above.

The hole 40 is configured to be insertable into the shaft 320 of the medical device 200. The hole 40 has a substantially circular shape when viewed from the axial direction in the present embodiment. In the present embodiment, the fusion promoting device 100 and the medical device 200 are configured so that the following relationship is established (see FIGS. 2 and 3).

d3> d4 + (d5-d6)
Here, d3 is the outer diameter of the punched portion 250 of the medical device 200, and d4 is the outer diameter of the reinforcing portion 30 provided on the outer periphery of the main body portion 10 in the fusion promoting device 100. d5 is the inner diameter of the second magnetic portion 20 provided on the inner circumference of the main body portion 10, and d6 is the outer diameter of the shaft 320 of the medical device 200. That is, the outer diameter d3 of the punched portion 250 is configured to be larger than the sum of the outer diameter d4 of the main body portion 10 and the inner diameter d5 of the main body portion 10 minus the outer diameter d6 of the shaft 320. ..

The manufacturing method of the main body 10 is not particularly limited. Regarding the portion of the through hole 11 of the main body portion 10, as an example, fibers containing the above-mentioned biodegradable material are arranged in a circumferential shape, and similar fibers are arranged in a radial direction to form a circumferential fiber and a radial fiber. A method of integrating with the fiber is conceivable. Examples of the method for producing the fiber made of biodegradable resin include an electrospinning method (electrospinning method / electrostatic spinning method) and a melt blow method. For the main body 10, only one of the above methods may be selected, or two or more thereof may be appropriately combined.

The main body 10 induces a biological reaction by a constituent material such as a biodegradable resin constituting the main body 10. The main body 10 induces the expression of biological components such as fibrin by this action. The biological components induced in this way can promote fusion by accumulating so as to penetrate through the through hole 11 of the main body 10. Therefore, by arranging the main body 10 of the fusion promoting device 100 between the biological organs to be joined, the fusion is promoted by the above mechanism.

<Treatment method>
Next, a treatment method using the fusion promoting device 100 will be described. 6 and 7 are flowcharts showing each procedure of the treatment method using the fusion promoting device 100. FIG. 8 is a schematic cross-sectional perspective view for explaining colorectal anastomosis.

The treatment method is a fusion promoting device 100 provided with a sheet-shaped main body 10 that promotes fusion of biological tissues between one first bonded site and the other second bonded site to be bonded to a biological organ. Includes placement (S11). The treatment method is that at least a part of the main body 10 of the fusion promoting device 100 is arranged between one first bonded site and the other second bonded site, and one first bonded site and the other It includes joining with the second jointed portion (S12).

The living organ to be joined by the treatment method and the joining site in the living organ are not particularly limited and can be arbitrarily selected. However, in the following description, colon anastomosis will be described as an example.

Further, in each procedure described below, detailed description of known procedure procedures and known joining devices will be omitted as appropriate.

Hereinafter, in the description of the present specification, "arranging a fusion promoting device between living organs (hereinafter referred to as the above description)" means that the healing promoting device is in direct or indirect contact with the living organ. It can mean that it is placed.

Further, the above description may mean that the fusion promoting device is arranged in a state where a spatial gap is formed between the living organ and the living organ. Further, in the above description, the fusion promoting device is arranged in both states (for example, the fusion promoting device is in contact with one biological organ and the fusion promoting device is not in contact with the other biological organ). To be done) can mean.

Further, in the description of the present specification, the term "periphery" does not define a strict range (region), but a predetermined range (region) as long as the purpose of treatment (bonding between biological organs) can be achieved. Means.

In addition, the order of the procedure procedures described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. Further, in the description of the present specification, "relatively approaching" means both bringing two or more objects to be approached close to each other and bringing only one close to the other.

In the treatment method according to the present embodiment, the biological organ to be joined is the large intestine that has been cut due to the excision of the cancer tumor. Specifically, the biological organs to be joined are the oral side A2 of the cut large intestine and the anal side A1 of the cut large intestine. In the following description, the procedure for joining the area around the mouth of the mouth side A2 of the cut large intestine (second joint site) and a part of the intestinal wall of the anal side A1 of the cut large intestine (first joint site) will be described. explain.

As shown in FIG. 7, the treatment method according to the present embodiment is to dispose the fusion promoting device 100 between the mouth of the large intestine and the intestinal wall of the large intestine (S101), the mouth of the large intestine and the intestine of the large intestine. Includes making the walls relatively close (S102). The treatment method is to sandwich the main body 10 of the fusion promoting device 100 between the periphery of the mouth of the large intestine and the intestinal wall of the large intestine (S103), and the fusion promoting device between the periphery of the mouth of the large intestine and the intestinal wall of the large intestine. This includes joining (S104) with the main body 10 sandwiched between 100. The details will be described below.

As shown in FIG. 8, the operator inserts the second engaging instrument 270 of the medical instrument 200 into the oral side A2 of the large intestine. The surgeon places the first engaging device 210 of the medical device 200 on the anal side A1 of the large intestine.

By arranging (inserting) the first engaging device 210 on the anal side A1 of the large intestine, a through hole A11 is formed on the anal side A1 of the large intestine. The timing of forming the through hole A11 is not particularly limited as long as it is before the first engaging device 210 is arranged.

Next, the surgeon inserts the shaft 320 of the second engaging instrument 270 into the oral side A2 of the large intestine and sutures the shaft 320 with a drawstring in a protruding state to form the sutured portion A21. The outer surface of the sewn portion A21 has a shape that partially protrudes to the convex side as the sewn portion A21 is sewn.

Next, as shown in FIG. 8, the operator places the fusion promoting device 100 between the oral side A2 of the large intestine and the anal side A1 of the large intestine (S101). When arranging the fusion promoting device 100, the operator passes the shaft 320 included in the second engaging instrument 270 through the hole 40 formed in the main body 10 as shown in FIG. At this point, the main body 10 is deformed so that the inside of the main body 10 in the radial direction r is raised as shown in FIG. 9 in accordance with the shape of the sutured portion A21 formed so as to be raised in the living body.

Even if the surgeon arranges the fusion promoting device 100 on the anal side A1 of the large intestine by passing the shaft of the positioning portion 230 included in the first engaging instrument 210 through the hole portion 40 formed in the main body portion 10. Good.

Next, the operator engages the shaft of the positioning portion 230 and the shaft 320 of the second engaging instrument 270 at a position separated from each other while maintaining the state in which the main body portion 10 is held with respect to the oral side A2 of the large intestine. Let me. Then, the rotating portion 261 is rotated so that the first engaging instrument 210 and the second engaging instrument 270 are relatively close to each other as shown in FIG. As a result, the periphery of the mouth of the large intestine and the intestinal wall of the large intestine are relatively close to each other (S102).

Next, the surgeon, between the first engaging instrument 210 and the second engaging instrument 270, is located around the mouth of the oral side A2 of the large intestine, the main body 10 of the fusion promoting device 100, and the anal side A1 of the large intestine. The periphery of the through hole A11 formed in the intestinal wall is sandwiched (S103).

The surgeon rotates the handle 262 of the operation unit 260 of the medical device 200 around the rotation shaft 263 to project the annular blade of the punching unit 250. Then, a part of the oral side A2 of the large intestine sandwiched between the first engaging device 210 and the second engaging device 270, the second magnetic part 20 of the main body portion 10, and a part of the anal side A1 of the large intestine. Is excised, and the periphery of the excised site is joined by staples (not shown) (S104).

Next, as shown in FIG. 11, the surgeon takes out the medical device 200 from, for example, the anal side A1 of the large intestine to the outside of the living body via the anus. At this time, the region formed inward from the outer diameter d3 of the punched portion 250 of the first engaging instrument 210 is taken out of the living body together with the medical instrument 200. As a result, in the fusion promoting device 100, the second magnetic portion 20 located inward in the radial direction r than the punched portion 250 is removed without remaining in the body.

By sandwiching and indwelling the main body 10 of the fusion promoting device 100 between the biological organs to be joined, it is possible to promote the fusion of the biological organs to be joined through the through hole 11 of the main body 10.

According to such a treatment method, a joining technique (for example, gastrointestinal anastomosis) is performed by a simple method of sandwiching the sheet-shaped main body portion 10 between the first joined portion and the second joined portion. It is possible to reduce the risk of subsequent suture failure.

As described above, the fusion promoting device 100 according to the present embodiment is used when joining the first joined portion and the second joined portion by the medical device 200. The medical device 200 is a magnetic material capable of joining a first bonded portion and a second bonded portion facing the first bonded portion and contacting the first bonded portion or the second bonded portion. A second engaging device 270 to which the first magnetic portion 310 including the above can be attached is provided. The fusion promoting device 100 has a main body portion 10 and a second magnetic portion 20. The main body 10 promotes the fusion of living tissues when the first jointed portion and the second joined portion are joined by the medical device 200. In the second magnetic portion 20, the main body portion 10 is arranged between the first bonded portion and the second bonded portion, and the second engaging instrument 270 is in contact with the first bonded portion or the second bonded portion. It is provided at a position facing the first magnetic portion 310 in the surface direction of the main body portion 10 when the main body portion 10 is formed. The second magnetic portion 20 is configured to be in close contact with the first magnetic portion 310 by the magnetic force received from the first magnetic portion 310.

The main body of the fusion promotion device is usually soft and easily twisted or misaligned. In addition, the main body of the fusion promoting device tends to have a weak force to adhere to living tissues such as the intestinal tract, and is likely to fall off. Regarding this, by providing the fusion promoting device 100 with a second magnetic portion 20 that can be brought into close contact with the first magnetic portion 310 of the medical device 200, it is possible to prevent or suppress misalignment with the medical device 200 that may cause dropping or the like. Can be done. As described above, according to the fusion promoting device 100, the risk of suture failure after surgery or the like can be reduced.

Further, the medical device 200 includes a first engaging device 210 and a second engaging device 270 capable of sandwiching the main body portion 10 via the first joined portion and the second joined portion. The second engaging instrument 270 includes a plate-shaped head 280, and the first magnetic portion 310 is attached to the head 280 so as to be integrated. With this configuration, the misalignment between the medical device 200 and the fusion promoting device 100 can be prevented or suppressed.

Further, the first engaging device 210 includes a discharging portion 240 and a punching portion 250. The discharge portion 240 is formed in a disk shape, and is configured to be capable of releasing a plurality of staples that join the first bonded portion and the second bonded portion. The punching portion 250 is configured to punch in the radial direction of the first bonded portion and the second bonded portion and to be arranged inward in the radial direction r than the discharging portion 240. The second engaging device 270 is provided on the side of the first engaging device 210 in the axial direction of the head 280, and includes a contact portion 290 capable of contacting a plurality of staples discharged from the discharging portion 240. The first magnetic portion 310 is provided on the side of the abutting portion 290 in the axial direction of the second engaging device 270, and is configured such that the outer diameter d1 is smaller than the inner diameter d2 of the abutting portion 290. The contact portion 290 has the same diameter as the discharge portion 240 and is close to the diameter of the punched portion 250. Therefore, by configuring as described above, even if there is a radial r gap between the hole 40 of the fusion promoting device 100 and the shaft 320 of the second engaging device 270, the second engaging device 270 It is possible to prevent the fusion promoting device 100 from being displaced with respect to the above. Further, by making the outer diameter of the second magnetic portion 20 smaller than the outer diameter d1 of the first magnetic portion 310, the risk of the second magnetic portion 20 being displaced outward from the punched portion 250 is reduced. The second magnetic portion 20 can be removed from the body by the punching portion 250.

Further, the first engaging device 210 includes a punched portion 250 formed in an annular shape by punching the inner side of the first joined portion and the second joined portion in the radial direction r. The second engaging device 270 includes a long shaft 320 provided on one side of the head 280 in the axial direction and having a circular cross section. The main body 10 includes a hole 40 through which the shaft 320 can be inserted. The outer diameter d3 of the punched portion 250 is configured to be larger than the sum of the outer diameter d4 of the main body portion 10 and the inner diameter d5 of the main body portion 10 minus the outer diameter d6 of the shaft 320. As a result, even if the fusion promoting device 100 is displaced (aligned) with respect to the shaft 320 of the second engaging device 270 due to the gap in the radial direction r between the hole 40 and the shaft 320, the second engagement device 100 is second. The magnetic portion 20 can be punched out and removed from the living tissue.

Further, at least one of the first magnetic part 310 and the second magnetic part 20 is configured to contain a hard magnetic material. As a result, even if the other is not a hard magnetic material, the two can be attracted to each other and brought into close contact with each other so that they can be aligned with each other.

<Modified example of the first embodiment>
Next, a modified example of the first embodiment will be described. FIG. 12 is a side view showing a second engaging device 270a of the medical device according to the modified example of the first embodiment. In the first embodiment, it is described that the first magnetic portion 310 is provided on the side of the contact portion 290 in the head 280, but it can also be configured as follows. In this modification, the fusion promoting device and the first engaging device of the medical device are the same as those in the first embodiment, and thus the description thereof will be omitted. Also in this modified example, the medical device including the second engaging device 270a and the fusion promoting device 100 can be combined to form a medical device set.

In the second engaging device 270a, the first magnetic portion 310a is provided on the side opposite to the contact portion 290 in the plate thickness direction of the head 280 (see direction X in FIG. 12) as shown in FIG. 12 in this modified example. .. The outer diameter d7 of the first magnetic portion 310a is configured to be larger than the outer diameter d3 (see FIG. 2) of the punching portion 250. Since other configurations and treatment methods in the second engaging device 270a are the same as those in the first embodiment, the description thereof will be omitted.

In this modification, the first engaging device 210 includes a discharging portion 240 and a punching portion 250 as in the first embodiment. The discharge unit 240 is arranged in a disk shape, and is configured to be capable of releasing a plurality of staples that join the first bonded portion and the second bonded portion. The punching portion 250 punches inward in the radial direction of the first bonded portion and the second bonded portion, and is arranged inward in the radial direction r than the discharging portion 240. The second engaging device 270a is provided on the side of the first engaging device 210 in the axial direction of the head 280 as in the first embodiment, and is in contact with a plurality of staples discharged from the discharge unit 240. A unit 290 is provided. The first magnetic portion 310a is provided on the side opposite to the contact portion 290 in the axial direction of the second engaging tool 270a, and is configured such that the outer diameter d7 is larger than the outer diameter d3 of the punching portion 250. Even with this configuration, the first magnetic portion 310a and the second magnetic portion 20 can prevent or suppress the misalignment between the fusion promoting device 100 and the medical device 200 so as not to cause the above-mentioned dropout or the like. ..

<Second Embodiment>
Next, the fusion promoting device 100 according to the second embodiment will be described. 13 and 14 are perspective views showing a fusion promoting device 100 and a second engaging device 270b of a medical device according to a second embodiment of the present invention. Also in this embodiment, the medical device set can be configured by combining the fusion promoting device 100 and the medical device including the second engaging device 270b.

In the first embodiment, it has been explained that the first magnetic portion 310 is attached to the head 280 of the second engaging device 270 and is integrated, but it can also be configured as follows. Since the first engaging device and the fusion promoting device 100 of the medical device are the same as those of the first embodiment, the description thereof will be omitted. Further, since the second engaging instrument 270b is the same as the second engaging instrument 270 of the first embodiment except that it does not include the first magnetic portion, the description thereof will be omitted.

In the second embodiment, the reinforcing member 400 is used for positioning the medical device and the fusion promoting device. The reinforcing member 400 is configured as a separate component from the first engaging device 210 and the second engaging device 270b. As shown in FIG. 13, the reinforcing member 400 includes a reinforcing portion 410, a mounting portion 420, a first magnetic portion 430, and a hole portion 440.

The reinforcing portion 410 provides a through hole 11 of a fusion promoting device 100 through which a body fluid such as blood flowing through the lumen of a living tissue passes through a staple or the like at a first jointed portion and a second bonded portion joined by a medical device. It is provided to prevent it from leaking to the outside. The reinforcing portion 410 is provided between the mounting portion 420 and the first magnetic portion 430 in the radial direction r. The reinforcing portion 410 can be configured in the same manner as the portion provided with the through hole 11 of the fusion promoting device 100. The reinforcing portion 410 reinforces the resistance to leakage of body fluid or the like from the main body portion 10 by providing a portion similar to the portion of the through hole 11 of the main body portion 10 as described above.

The mounting portion 420 is configured so that the reinforcing member 400 can be mounted on the second engaging device 270b on the outer side in the radial direction r. As shown in FIG. 13, the mounting portion 420 is partially provided on the outer periphery of the reinforcing portion 410 in the present embodiment. In the present embodiment, the mounting portion 420 has a plurality of substantially triangular shapes having vertices facing outward in the radial direction r arranged on the outer periphery of the reinforcing portion 410.

As a result, if the medical device 200 is rotated in the circumferential direction θ with respect to the reinforcing member 400 in a state where the reinforcing member 400 is attached to the second engaging device 270b, the reinforcing portion 410, the first magnetic portion 430, and the mounting portion 420 are formed. And separate. By the above operation, the second engaging instrument 270b and the fusion promoting device 100 are aligned at the time of joining the first joined portion and the second joined portion, and the reinforcement is prevented from leaking from the needle hole after joining. The portion 410 can be placed at the joint site together with the fusion promoting device 100.

The first magnetic part 430 is configured in a ring shape like the first magnetic part 310 in the first embodiment, and the first magnetic part 430 corresponds to the ring part. Therefore, detailed description will be omitted.

The hole 440 is provided to attach the reinforcing member 400 to the medical device 200b. The hole 440 is configured to be inserted into the shaft 320 of the second engaging device 270b in the present embodiment. The hole 440 is configured to have a diameter similar to the outer diameter of the shaft 320 in the present embodiment, but the specific dimensional relationship is not limited to the above as long as the reinforcing member 400 can be attached to the medical device 200b.

<Treatment method>
Next, the treatment method according to the present embodiment will be described. First, the operator inserts the hole 440 of the reinforcing member 400 into the shaft 320 of the second engaging instrument 270b. Then, the mounting portion 420 of the reinforcing member 400 is attached to the head 280 of the second engaging device 270b to integrate the reinforcing member 400 with the second engaging device 270b. Then, the fusion promoting device 100 is arranged between the oral side A2 of the large intestine and the anal side A1 of the large intestine (S101). When arranging the fusion promoting device 100, the operator passes the shaft 320 included in the second engaging instrument 270b through the hole 40 formed in the main body 10.

Next, the operator engages the shaft of the positioning portion 230 and the shaft 320 of the second engaging instrument 270b at a position separated from each other while maintaining the state in which the main body portion 10 is held with respect to the oral side A2 of the large intestine. Let me. Then, the rotating portion 261 is rotated so that the first engaging instrument 210 and the second engaging instrument 270 are relatively close to each other as shown in FIG. As a result, the periphery of the mouth of the large intestine and the intestinal wall of the large intestine are relatively close to each other (S102).

Next, the surgeon, between the first engaging instrument 210 and the second engaging instrument 270b, around the mouth of the oral side A2 of the large intestine, the reinforcing portion 410 of the reinforcing member 400, and the main body of the fusion promoting device 100. 10. The area around the through hole A11 formed in the intestinal wall of the anal side A1 of the large intestine is sandwiched (S103).

The operator rotates the handle 262 of the operation portion 260 of the first engaging tool 210 around the rotation shaft 263 to project the annular blade of the punching portion 250. Then, a part of the oral side A2 of the large intestine sandwiched between the first engaging device 210 and the second engaging device 270b, the first magnetic portion 430 of the reinforcing member 400, and the second magnetic portion 20 of the main body portion 10. , And a part of the anal side A1 of the large intestine is excised. Then, the periphery of the excised portion is joined by staples (not shown) (S104).

Next, as shown in FIG. 11, the surgeon takes out the medical device including the first engaging device 210 and the second engaging device 270b from, for example, the anal side A1 of the large intestine to the outside of the living body via the anus. At this time, the region formed inward from the outer diameter d3 of the punched portion 250 of the first engaging device 210 of the medical device is taken out of the living body together with the medical device. In other words, the portion of the reinforcing portion 410 of the reinforcing member 400 outside the outer diameter d3 of the punched portion 250 and the portion of the through hole 11 of the main body portion 10 of the fusion promoting device 100 are between the first bonded portion and the second bonded portion. It is detained while being sandwiched between them. By indwelling not only the main body 10 of the fusion promoting device 100 but also the reinforcing member 400 between the first bonded portion and the second bonded portion in this way, leakage of blood or the like from the staple portion is prevented. be able to.

As described above, in the present embodiment, the first engaging instrument 210 is formed in an annular shape by punching the inner side of the first joined portion and the second joined portion in the radial direction r as in the first embodiment. A punching portion 250 is provided. The second engaging device 270b includes a long shaft 320 provided on the side of the first engaging device 210 in the axial direction of the head 280. The main body 10 includes a hole 40 that can be inserted into the shaft 320. The first magnetic portion 430 is provided on the reinforcing member 400, which is a separate component from the first engaging device 210 and the second engaging device 270b. The reinforcing member 400 provided with the first magnetic portion 430 is attached to the second engaging device 270b. The reinforcing member 400 provided with the first magnetic portion 430 is configured to have a ring shape facing the second magnetic portion 20 of the main body portion 10 when the hole portion 440 is inserted through the shaft 320. With this configuration, even if the medical device 200b itself does not have the first magnetic portion paired with the second magnetic portion, the fusion promoting device 100 can be positioned with respect to the medical device 200b, and the fusion promoting device 100 can be positioned. Can be prevented from falling off.

Further, the reinforcing member 400 is provided between the mounting portion 420 that can be attached to the second engaging device 270b in the radial direction r and the ring shape of the first magnetic portion 430 and the mounting portion 420 in the radial direction r. A reinforcing portion 410 is provided to reinforce the main body portion 10. The mounting portion 420 is configured to be partially provided on the outer periphery of the reinforcing portion 410. With this configuration, the reinforcing member 400 is integrated with the second engaging device 270b, the reinforcing member 400 is arranged at the joint site together with the fusion promoting device 100, and the medical device 200b is rotated in the circumferential direction θ. The portion 420 is separated from the reinforcing portion 410. As a result, the reinforcing member 400 can be fixed to the second engaging device 270b until the first joined portion and the second joined portion are joined. Then, by separating the reinforcing portion 410 from the mounting portion 420 after joining, the reinforcing portion 410 that prevents leakage from the staple portion at the joining portion can be placed in the living body.

The present invention is not limited to the above-described embodiment, and various modifications can be made within the scope of the claims. In the first embodiment, when the shaft 320 of the second engaging device 270 of the medical device 200 is inserted into the suture portion A21 and inserted into the hole 40 of the fusion promoting device 100, the inside of the main body portion 10 in the radial direction r. It was explained that the sewn portion A21 is deformed so as to be raised according to the shape of the sewn portion A21. However, the shape of the main body 10 in the radial direction r is not limited to this, and the shape of the product itself is similar to the shape of the stitched portion A21 in the radial direction r even if it is not adjacent to the stitched portion A21. A shape that rises in the longitudinal direction (direction X) may be provided. As a result, the alignment with the sutured portion A21 becomes easy, and the fusion promoting device 100 can be prevented from falling off when the first bonded portion and the second bonded portion are joined by that amount.

Further, in the above, the embodiment in which the first magnetic part and the second magnetic part have a substantially disk shape has been described. However, the present invention is not limited to the above, and a convex portion may be added to the disk shape of the first magnetic portion, and a concave portion corresponding to the convex portion of the first magnetic portion may be provided in the second magnetic portion. As a result, the first engaging device or the second engaging device constituting the medical device can be easily aligned with the fusion promoting device, and the fusion promoting device can be prevented from falling off at the time of joining.

Further, in the second embodiment, the embodiment in which the reinforcing member 400 is attached to the second engaging device 270b by sticking or the like has been described, but the present invention is not limited to this. In addition to the above, the case where the reinforcing member is attached to the first engaging device and integrated is also included in one embodiment of the present invention. Even in such a case, the mounting portion is separated from the reinforcing portion by integrating the reinforcing member with the first engaging device and rotating the medical device in the circumferential direction θ with the reinforcing member arranged at the joint portion in the same manner as described above. To do. As a result, a reinforcing portion that prevents leakage from the staple portion can be placed at the joint portion.

This application is based on Japanese Patent Application No. 2019-174342 filed on September 25, 2019, the disclosure of which is cited as a whole by reference.

100 fusion promotion device,
10 Main body,
20 Second magnetic part,
40 holes,
200 medical devices,
210 First Engagement Device,
240 discharge part,
250 punching part,
270, 270a, 270b second engaging device,
280 heads,
310, 310a, 430 1st magnetic part,
d1, d7 outer diameter (outer diameter of the first magnetic part),
d2 inner diameter (inner diameter of contact part),
d3 outer diameter (outer diameter of punched part)
d4 outer diameter (outer diameter of the main body),
d5 inner diameter (inner diameter of the main body),
d6 outer diameter (shaft outer diameter),
r radial direction (radiation direction),
θ Circumferential direction (angle direction).

Claims

A magnetic material capable of joining a first jointed portion in a living tissue and a second joined portion facing the first joined portion and contacting the first joined portion or the second joined portion. When the first bonded portion and the second bonded portion are joined by a medical device provided with an engaging device to which the first magnetic portion including the above can be attached, a main body portion that promotes fusion of biological tissues and a main body portion.
When the main body portion is arranged between the first joined portion and the second joined portion and the engaging device is brought into contact with the first joined portion or the second joined portion, the said A fusion promoting device having a second magnetic portion that is provided at a position facing the first magnetic portion in the surface direction of the main body portion and that can be brought into close contact with the first magnetic portion by the magnetic force received from the first magnetic portion.
The engaging device includes a first engaging device and a second engaging device capable of sandwiching the main body portion via the first joined portion and the second joined portion.
The second engaging device includes a disc-shaped head.
The fusion promoting device according to claim 1, wherein the first magnetic portion is attached to the head and integrated.
The first engaging device is arranged in a disk shape, and has a release portion capable of releasing a plurality of staples that join the first joined portion and the second joined portion, and the first joined portion. The second bonded portion is provided with a punching portion that is punched inward in the radial direction and is arranged inward in the radial direction from the discharging portion.
The second engaging device is provided on the side of the first engaging device in the plate thickness direction of the head, and includes a contact portion capable of contacting a plurality of the staples discharged from the discharging portion. ,
The fusion promoting device according to claim 2, wherein the first magnetic portion is provided on the side of the contact portion in the plate thickness direction of the head, and the outer diameter is smaller than the inner diameter of the contact portion.
The first engaging device is arranged in a disk shape, and has a release portion capable of releasing a plurality of staples that join the first joined portion and the second joined portion, and the first joined portion. The second bonded portion is provided with a punching portion that is punched inward in the radial direction and is arranged inward in the radial direction from the discharging portion.
The second engaging device is provided on the side of the first engaging device in the plate thickness direction of the head, and includes a contact portion capable of contacting a plurality of the staples discharged from the discharging portion. ,
The fusion promoting device according to claim 2, wherein the first magnetic portion is provided on the side opposite to the contact portion in the plate thickness direction of the head, and the outer diameter is larger than the outer diameter of the contact portion.
The first engaging device includes a punched portion formed in an annular shape by punching the first joined portion and the second joined portion in the radial direction.
The second engaging device includes a long shaft provided on the side of the first engaging device in the axial direction of the head.
The main body has a hole that can be inserted into the shaft.
The first magnetic part is a separate part from the first engaging device and the second engaging device, and is attached to either the first engaging device or the second engaging device, and the main body portion. The fusion promoting device according to claim 2, further comprising a ring portion facing the second magnetic portion of the main body portion when the hole portion is inserted into the shaft.
The separate component is provided between a mounting portion that can be mounted on either the first engaging device or the second engaging device in the radial direction and between the ring portion and the mounting portion in the radial direction. It is further provided with a reinforcing portion for reinforcing the main body portion.
The fusion promoting device according to claim 5, wherein the mounting portion is partially provided on the outer periphery of the reinforcing portion.
The first engaging device includes a punched portion formed in an annular shape by punching the first joined portion and the second joined portion in the radial direction.
The second engaging device includes a long shaft provided on one side of the head in the axial direction and having a circular cross section.
The main body has a circular hole through which the shaft can be inserted.
The fusion promoting device according to claim 2, wherein the inner diameter of the punched portion is larger than the sum of the outer diameter of the main body portion and the inner diameter of the main body portion minus the outer diameter of the shaft.
The fusion promoting device according to any one of claims 1 to 7, wherein at least one of the first magnetic part and the second magnetic part contains a hard magnetic material.