JP2022147531A - Fusion-accelerating device and medical appliance set - Google Patents

Abstract

To provide a medical appliance set that prevents or restrains slippage in living organs or prevents dropping from living organs when disposed in an adhesion target in the living organs.SOLUTION: A medical appliance set 1 according to the present invention comprises: a sheet-like body portion 10 which is disposed between living organs to be adhered and accelerates fusion of living tissues; and a displacement portion which is provided adjacent to the body portion in a thickness direction of the body portion and, in which at least an inner side S1 is displaced inwardly in a face direction YZ of the body portion due to increase of volume.SELECTED DRAWING: Figure 5

Description

The present invention relates to a fusion promoting device and medical instrument set.

2. Description of the Related Art Techniques for surgically joining living organs (for example, gastrointestinal anastomosis) are known in the medical field. It is known that it is important as a postoperative prognostic factor that there is no delay in union at the junction where the living organs are joined together when the above procedures are performed.

Various methods and medical instruments are used in procedures for joining biological organs. ) has been proposed. In particular, when performing anastomosis using a mechanical anastomosis device, the risk of suture failure can be reduced because the bonding force between living organs at the joint can be increased compared to the method using suture thread. becomes possible.

Japanese Patent Publication No. 2007-505708

In the anastomosis device of Patent Document 1, a sheet-like member such as a support structure is sandwiched in order to prevent leakage, tearing, or the like at the joint site, thereby promoting fusion of the joint site. Devices that promote such fusion (hereinafter referred to as fusion-promoting devices) are typically relatively thin and soft. Therefore, there is a problem that the sheet-like adhesion promoting device is likely to be displaced from the position intended by the operator or to fall off when the device is sandwiched between the relevant parts of the living tissue.

Accordingly, the present invention has been made to solve the above-described problems, and is capable of preventing or suppressing displacement from a living organ or preventing falling-off from the living organ when placed on a joining target of the living organ. intended to

One aspect of the present invention is a fusion promoting device that includes a body portion and a deformation portion. The main body is arranged between living organs to be joined, promotes fusion of living tissues, and is formed in a sheet shape. The deformation portion is provided adjacent to the body portion in the thickness direction of the body portion, and at least the inner side is displaced inward in the surface direction of the body portion due to the increase in volume.

Further, according to one aspect of the present invention, the above-described adhesion promoting device is joined to one joined site and the other joined site, which are biological organs to be joined, and a first engagement is provided in which the fusion promoting device can be sandwiched. a medical instrument comprising an instrument and a second engaging instrument. The second engaging device engages with the first engaging device and includes a shaft that can be inserted through the deformed portion of the fusion promoting device and can abut on the inner side displaced inward in the planar direction.

ADVANTAGE OF THE INVENTION According to the fusion promoting device and the medical instrument set according to one aspect of the present invention, when placed on a joint target in a living organ, it prevents or suppresses displacement from the living organ, and prevents falling off from the living organ. be able to.

1 is a schematic perspective view showing a medical instrument set according to a first embodiment of the present invention; FIG. 2 is a perspective view showing the tip of a first engaging instrument and a second engaging instrument that constitute the medical device according to FIG. 1; FIG. FIG. 10 is a perspective view showing a state in which the fusion promoting device is inserted through the shaft of the second engaging instrument that constitutes the medical device; FIG. 10 is a diagram showing a state in which the deformable portion that constitutes the fusion promoting device is brought into contact with the shaft of the medical instrument; FIG. 4 is a diagram showing a state in which the adhesion promoting device is cut along the thickness direction (axial direction). FIG. 4 is a cross-sectional view showing a through-hole provided in the main body of the fusion promoting device; 4 is a flow chart showing each procedure of a treatment method using the medical instrument set. 1 is a flow chart showing the procedure of an embodiment of a treatment method (colonic anastomosis). It is a figure explaining large intestine anastomosis using a medical device. It is a figure explaining large intestine anastomosis using a medical device. It is a figure explaining large intestine anastomosis using a medical device. 6A and 6B are diagrams showing modifications of the arrangement of the deformable portion with respect to the main body portion of the fusion promoting device shown in FIG. 5. FIG. 6 is a diagram showing a modification of the connection relationship between the body portion and the deformation portion of the fusion promoting device shown in FIG. 5. FIG. 6 is a diagram showing a modification of the connection relationship between the body portion and the deformation portion of the fusion promoting device shown in FIG. 5. FIG. FIG. 10 is a diagram showing a state in which the fusion promoting device according to the second embodiment is cut along the thickness direction; FIG. 10 is a diagram showing a deformed portion of the fusion promoting device according to a modified example of the second embodiment;

EMBODIMENT OF THE INVENTION Hereinafter, the form for implementing this invention is demonstrated in detail, referring drawings. The embodiment shown here is an example for embodying the technical idea of the present invention, and does not limit the present invention. In addition, other practicable modes, embodiments, operation techniques, etc. that can be conceived by those skilled in the art without departing from the gist of the present invention are all included in the scope and gist of the present invention, and are described in the scope of claims. included within the scope of the claimed invention and its equivalents.

Furthermore, the drawings attached to this specification may be represented schematically by appropriately changing the scale, length-to-width ratio, shape, etc. from the actual thing for the convenience of illustration and ease of understanding. and does not limit the interpretation of the present invention.

In the following description, ordinal numbers such as "first" and "second" will be used, but unless otherwise specified, they are used for convenience and do not prescribe any particular order.

Note that the coordinate system is shown in the drawings below. The X of the orthogonal coordinate system is along the axial direction or thickness direction of the main body 10 that constitutes the fusion promoting device 100, and is referred to as the axial direction X. Y and Z are planes that intersect the axial direction X and are referred to as planar directions YZ.

The r of the cylindrical coordinate system is a direction extending radially or radially from the center of the body portion 10 of the fusion promoting device 100 along the planar direction YZ, and is referred to as the radial direction r. θ is along the circumferential direction or angular direction of the main body 10 or the like in the plane direction YZ intersecting the axial direction X of the main body 10 or the like, and is referred to as the circumferential direction θ.

<First embodiment>
FIG. 1 shows a medical instrument set 1 according to a first embodiment of the present invention. FIG. 2 is a diagram showing the distal end portion of the first engagement tool 210 and the second engagement tool 270 that constitute the medical device 200 that constitutes the medical instrument set 1. FIG. 3 and 4 are diagrams showing a state in which the shaft 310 of the second engagement tool 270 is inserted through the hole 30 of the fusion promoting device 100. FIG. FIG. 5 is a diagram showing the deformable portion 40 and the like of the fusion promoting device 100. As shown in FIG.

FIG. 6 is a diagram showing the through-hole 11 of the fusion promoting device 100. FIG. 7 to 11 are diagrams for explaining the anastomosis of the gastrointestinal tract, taking the large intestine as an example, using the fusion promoting device 100 that constitutes the medical instrument set 1. FIG.

The medical instrument set 1, as outlined with reference to FIG. 1, has a fusion promoting device 100 and a medical device 200 used together with the fusion promoting device 100 during anastomosis.

As shown in FIGS. 7 to 11, the fusion promoting device 100 can be applied to procedures for joining predetermined living organs (for example, gastrointestinal anastomosis). As will be described later, in the description of this specification, colon anastomosis will be described as an example of a 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 medical instrument set 1 is used to join a first site to be joined such as the large intestine and a second site to be joined using the medical device 200 . Before explaining the medical instrument set 1, the medical device 200 will be explained.

<Medical devices>
The medical device 200 joins one to-be-joined site (first to-be-joined site), which is a living organ in living tissue, and the other to-be-joined site (second to-be-joined site) facing the first to-be-joined site. The medical device 200 comprises a first engaging device 210 and a second engaging device 270 capable of sandwiching the fusion promoting device 100 via the first site to be joined and the second site to be joined.

The first engaging instrument 210 is arranged on one side of the fusion promoting device 100 when the fusion promoting device 100 is anastomosed to the living tissue as shown in FIG. 10 and the like. The first engaging tool 210 is configured to be able to contact the first joined portion.

The second engaging device 270 is arranged on the side opposite to the first engaging device 210 with respect to the union promoting device 100 during anastomosis, and is configured to be able to abut on the second site to be joined. Details will be described later. First engagement device 210 may be referred to as a trocar and second engagement device 270 may be referred to as an anvil. Details will be described below.

<First engagement device>
The first engaging device 210 includes an elongated member 220, a positioning portion 230, a releasing portion 240, a punching portion 250, and an operating portion 260, as shown in FIGS.

The elongated member 220 corresponds to the main body of the first engaging device 210 . As shown in FIG. 2 , the long member 220 has a space S at its longitudinal end in which the shaft of the positioning portion 230 can move forward and backward. In this specification, the axial direction X is the direction in which the distal end portion of the long member 220 extends linearly. The elongated member 220 has a hollow circular cross-section that intersects with the axial direction.

In this embodiment, the long member 220 extends linearly in the longitudinal direction and has a bent portion. good too.

The positioning part 230 has an elongated shaft. As shown in FIG. 2, the shaft of the positioning part 230 is configured so as to move forward and backward relative to the space S at the longitudinal end of the long member 220 . The positioning portion 230 is configured to be able to be inserted through the hole portion 30 formed by the inner reinforcing portion 21 of the fusion promoting device 100 and the shaft 310 of the second engagement tool 270 described later.

The releasing part 240 is configured to release a plurality of staples (corresponding to anastomosis members) for joining the first site to be joined and the second site to be joined. The ejection portion 240 is formed in a substantially disk shape on the distal end side of the elongated member 220 in the longitudinal direction. The ejecting portion 240 is configured by providing a plurality of staple ejecting points along the circumferential direction θ at the distal end of the long member 220 .

The punching part 250 is arranged radially inward of the discharge part 240 at the distal end of the long member 220, and is configured to punch radially inwards of the first and second parts to be joined. there is As shown in FIG. 2, the punching part 250 is configured to have an annular blade that punches out the first and second parts to be joined radially inward of the discharge part 240 in the r direction. The shape of the punched portion 250 can be a perfect circle when viewed in plan from the longitudinal direction, but the shape of the punched portion 250 may be an ellipse or the like as long as it punches out a portion that is not necessary for promoting healing.

The operation part 260 is configured to be able to operate the positioning part 230 , the ejection part 240 and the punching part 250 . The operating section 260 includes a rotating section 261 and a handle 262 as shown in FIG.

The rotating portion 261 is provided at the proximal end portion (base end side) of the elongated member 220 in the longitudinal direction. The rotating portion 261 is configured to be rotatable with respect to the elongated member 220 with the longitudinal direction of the base end side of the elongated member 220 as a rotation axis. The rotating portion 261 rotates the elongated member 220 in a state where the second engaging device 270 is engaged with the first engaging device 210 , thereby rotating the first engaging device 210 and the second engaging device 270 . can be moved relatively close to each other.

The handle 262 is configured to be grippable by the user together with the base end (base end side) of the elongated member 220 . Handle 262 is rotatably connected to elongated member 220 by pivot 263 . The handle 262 rotates around the rotation axis 263 and relatively approaches the elongated member 220 when gripped by the user. Thereby, the staple is discharged from the discharging part 240 and the annular blade of the punching part 250 can be projected from the tip of the long member 220 .

<Second engagement device>
The second engaging device 270 is configured to be able to sandwich the healing promoting device 100 together with the first engaging device 210 via the first site to be joined and the second site to be joined. The second engagement device 270 includes a head 280, an abutment portion 290, and a shaft 310, as shown in FIG.

The head 280 is arranged particularly adjacent to the distal end side of the elongate member 220 of the first engaging device 210 when the first engaging device 210 and the second engaging device 270 are engaged. 2 and 3, the head 280 has a cross-sectional shape that is the same as or similar to the circular shape of the long member 220. As shown in FIGS.

The abutting portion 290 is configured to abut against a plurality of staples ejected from the ejecting portion 240 . The contact portion 290 is provided on the side of the first engaging device 210 in the axial direction X (thickness direction) of the head 280 . The abutting portion 290 is configured to abut against a plurality of staples ejected from the ejecting portion 240 . The staple ejected from the ejecting portion 240 abuts at the abutment portion 290 and deforms to join the first to-be-joined portion and the second to-be-joined portion.

The shaft 310 is configured to be able to pass through a hole 30 and a deformable portion 40 of the fusion promoting device 100, which will be described later. The shaft 310 includes a first shaft 311 and a second shaft 312 connected to the first shaft 311, as shown in FIG. The second shaft 312 is provided closer to the head 280 than the first shaft 311 is. The first shaft 311 is configured coaxially with the second shaft 312, and the cross section of the first shaft 311 and the second shaft 312 that intersects the axial direction X has a hollow circular shape.

In this embodiment, the second shaft 312 is configured to have a smaller outer peripheral dimension than the first shaft 311 . The first shaft 311 is configured to be engageable with the shaft of the positioning portion 230 and is provided to engage the first engaging device 210 and the second engaging device 270 . The first shaft 311 and the second shaft 312 are configured to elongate in the axial direction X from the head 280 toward the first engaging device 210 .

A space is provided in the shaft 310 to accommodate the shaft of the positioning portion 230 of the first engaging device 210 . The shaft 310 is configured to mate with the shaft of the positioning portion 230 , thereby enabling alignment of the first engagement device 210 and the second engagement device 270 .

<Healing promotion device>
The fusion promoting device 100 includes a body portion 10, a reinforcing portion 20, a hole portion 30, and a deformation portion 40, as shown in FIG.

<Body part>
The main body 10 is arranged between living organs to be joined, and promotes fusion of living tissues. The body portion 10 is configured in a sheet shape as shown in FIG. 5 and the like.

As shown in FIG. 3, the main body 10 is formed in a circular shape as an example, and as shown in FIG. Provide multiple. As an example, the size of the through-hole 11 of the main body 10 is preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, still more preferably 0.6 to 1.5 mm. The body portion 10 can be configured such that the ratio of the dimension D of the through holes 11 to the pitch P is 0.25 or more and less than 40.

The thickness of main body 110 (dimension T shown in FIG. 6) is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm.

The main body 10 can be made of biodegradable material. There are no particular restrictions on the constituent material of the main body 10, and examples include biodegradable resins.

Specifically, (1) selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose Polymer; (2) a copolymer composed of one or more monomers constituting the above (1);

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 cellulose. It preferably contains at least one biodegradable resin selected from the group consisting of polymers and copolymers composed of one or more monomers constituting the polymer.

<Reinforcement part>
The reinforcement part 20 is provided to suppress twisting, displacement, breakage, etc. of the fusion promoting device 100 when the device 100 is placed between the first site to be bonded and the second site to be bonded by the medical device 200. be provided. The reinforcing portion 20 includes an inner reinforcing portion 21 and an outer reinforcing portion 22 as shown in FIG. The inner reinforcing portion 21 is formed along the inner peripheral edge of the hollow circular body portion 10 , and the outer reinforcing portion 22 is formed along the outer peripheral edge of the hollow circular body portion 10 .

The inner reinforcing portion 21 and the outer reinforcing portion 22 are formed in a shape in which the through hole 11 is not provided in the main body portion 10 in this embodiment. However, the specific shape of the reinforcing portion 20 is not limited to the above, and the position may not be the inner peripheral edge or the outer peripheral edge, as long as the fusion promoting device 100 can be prevented or prevented from twisting or slipping and the strength can be improved.

<Hole>
The hole portion 30 is configured to be spaced apart from the outer peripheral edge portion of the main body portion 10 in the plane direction YZ of the main body portion 10 . The hole 30 is configured so that the shaft 310 of the medical device 200 can be inserted therethrough. The hole portion 30 is configured in a substantially circular shape when viewed from the axial direction X in this embodiment. However, the specific shape of the hole is not limited to a circular shape, as long as the body can promote the fusion of living tissue.

<deformation part>
The deformation portion 40 is provided adjacent to the body portion 10 in the thickness direction of the body portion 10 as shown in FIG. Displace. The deformation portion 40 is arranged at a position different from that of the main body portion 10 in the thickness direction in the present embodiment. The deformation section 40 includes an expansion section 41 , a first internal space 42 and an injection section 43 .

The expansion part 41 is configured to provide a first internal space 42 capable of accommodating a fluid such as liquid or gas that increases the volume and displaces at least the inner side S1 inward in the plane direction YZ of the body part 10. .

In this embodiment, as shown in FIG. 3, the extension part 41 is formed in an annular shape with the inner side S1 connected around so that the shaft 310 of the second engagement tool 270 of the medical device 200 can be inserted therethrough.

Here, the inner side S1 of the expanded portion 41 is configured to be more easily displaced inward in the radial direction r by the supply of fluid to the first internal space 42 than the outer side S2. As shown in FIG. 5, the expanded portion 41 has a first radial dimension d1 larger than a second thickness dimension d2 before the volume is increased.

The extension part 41 can be made of an elastic material, and the extension part 41 is configured so as to change the easiness of stretching for each part. Here, if the inner side S1, the outer side S2 of the rectangular cross section, the connecting portion S3 with the main body portion 10, and the opposite side of the connecting portion S3 in the axial direction X are the top portion S4, the degree of elongation is in descending order of the inner side S1 and the top portion. It can be S4, outer S2, connection S3. In other words, the outer side S2 of the extension 41 can be configured such that the surface elongation is more limited than the inner side S1 and so on.

As a method for changing the stretchability of each part of the expansion part 41, the thickness of the material is changed for each part, the part that is not desired to be stretched is treated to harden the surface, and the part that is desired to be hardened is framed with a net or wire. It is possible to form a shape such as

In this embodiment, the deformable portion 40 is configured to be integrated with the main body portion 10 by an adhesive, heat-sealing, or the like. By configuring in this way, the connection portion S3 can be made difficult to stretch. In the present embodiment, the extension part 41 has a substantially rectangular cross section along the thickness direction as shown in FIG. However, if the deformation portion can be fixed to the shaft 310 by increasing the volume, the cross-sectional shape is not limited to a rectangle, and may be a circular shape such as other polygons or ellipses.

The injection part 43 is provided on the outer surface of the extension part 41 and configured to allow fluid to flow through the first internal space 42 . The injection part 43 can be configured to include a hole that can be connected to a tube such as an inflator.

The material of the deformation portion 40 is not particularly limited as long as the inner side S1 can be displaced radially inward from the state before deformation. The material of the deformation portion 40 is polyethylene, polypropylene, polyolefin of ethylene-propylene copolymer, polyester such as polyethylene-terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, polyurethane. Thermoplastic resins such as polyamides, polyamide elastomers, polystyrene elastomers, silicone rubbers, latex rubbers, and the like can be used.

A method for manufacturing the main body 10 is not particularly limited, but for example, a method of manufacturing fibers made of the biodegradable resin described above and manufacturing a mesh-shaped sheet using the fibers can be mentioned. A method for producing fibers made of a biodegradable resin is not particularly limited, but examples thereof include an electrospinning method (electrospinning method/electrostatic spinning method) and a meltblowing method. For the main body 10, only one of the above methods may be selected and used, or two or more methods may be selected and appropriately combined. As still another example of the method for manufacturing the main body 10, the biodegradable sheet according to the present invention can be obtained by spinning fibers made of the above-described biodegradable resin according to a conventional method and knitting the obtained fibers into a mesh. , a method of producing the biodegradable sheet by compressing the fibers, and a method of producing the biodegradable sheet by entangling the fibers without weaving.

The main body 10 causes a bioreaction by using a constituent material such as a biodegradable resin that constitutes the main body 10 . By this action, the main body 10 induces the expression of biological components such as fibrin. The biocomponents induced in this manner penetrate through the through holes 11 of the main body 10 and accumulate, thereby promoting the fusion. Therefore, by arranging the body part 10 of the fusion promoting device 100 between the living organs to be bonded, the fusion is promoted by the above mechanism.

<Treatment method>
Next, a treatment method using the healing promoting device 100 will be described. FIG. 7 is a flow chart showing each procedure of the treatment method using the fusion promoting device.

In the treatment method, as shown in FIG. 7, a sheet-like main body portion 10 that promotes fusion of living tissue is placed between a first site to be bonded on one side and a second site to be bonded on the other side, which are objects to be bonded with living organs. Placing (S11) a fusion promoting device 100 comprising: In the treatment method, one first to-be-joined site and the other second to-be-joined site are placed in a state in which at least a part of the main body portion 10 of the healing promoting device 100 is placed between the one first to-be-joined site and the other second to-be-joined site. It includes joining the second joined site (S12).

The living organ to be joined by the treatment method and the site to be joined in the living organ are not particularly limited and can be arbitrarily selected. However, in the following description, colon anastomosis will be taken as an example. Further, in each technique described below, detailed descriptions of known technique procedures and known joining devices will be omitted as appropriate.

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

Also, the above description can mean that the fusion promoting device is arranged with a spatial gap formed between it and the living organ. In addition, the above description also states that the adhesion promoting device is placed in both states (for example, the device is placed in contact with one living organ and not in contact with the other living organ). be done).

In addition, in the description of this specification, the term "periphery" does not define a strict range (region). means

In addition, the order of the procedure described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. In addition, in the description of this specification, "bringing relatively close together" means both bringing two or more objects to be brought closer together and bringing only one of them closer to the other.

FIG. 8 is a flow chart showing the procedure of an embodiment of the treatment method (colonic anastomosis). 9 to 11 are diagrams for explaining colon anastomosis.

In the treatment method according to this embodiment, the living organ to be joined is the large intestine that has been cut along with resection of the cancer tumor. Specifically, the living organs to be joined are the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine. In the following description, the procedure for joining the oral periphery (one site to be joined) of the mouth side A1 of the cut large intestine and a part of the intestinal wall on the anal side A2 of the cut large intestine (the other site to be joined) will be described. explain.

As shown in FIG. 8, the treatment method according to the present embodiment includes disposing the fusion promoting device 100 between the mouth of the large intestine and the intestinal wall of the large intestine (S101), Including bringing the walls relatively close together (S102). The treatment method is to sandwich the main body 10 of the adhesion-promoting device 100 between the periphery of the mouth of the large intestine and the wall of the large intestine (S103), and insert the device between the periphery of the mouth of the large intestine and the wall of the large intestine. It includes joining the main body part 10 of 100 in a sandwiched state (S104). Details will be described below.

First, the operator forms a hole-like portion called a port around the navel and inflates the patient's abdomen.

Next, the operator forms an incision (not shown) around the navel, takes out the affected part on the oral side A1 from the incision, and inserts the second engaging tool 270 of the medical device 200 into the oral side A1 of the large intestine. insert The operator inserts the head 280 of the second engaging instrument 270 into the mouth side A1 of the large intestine, performs purse-string suture with the shaft 310 protruded, and forms the sutured portion A11. The outer surface of the sewn portion A11 has a shape that partially protrudes to the convex side as a result of the sewing (see FIG. 9).

Next, as shown in FIG. 9, the operator places the fusion promoting device 100 on the living tissue on the mouth side A1 of the large intestine (S101). Then, the operator connects a tube (not shown) connected to an inflator to the injection part 43 of the deformation part 40 to supply fluid to the first internal space 42 .

As a result, the volume of the first internal space 42 of the deformable portion 40 increases. Further, the wall surface of the deformable portion 40 is configured such that the inner side S1 is easier to deform than the outer side S2. As a result, the deformable portion 40 expands only inward in the radial direction r, or the inner side S1 expands inwardly from the outer side S2, as indicated by the two-dot chain line in FIG.

As a result, the inner side S1 of the deforming portion 40 abuts against the shaft 310 of the second engagement tool 270 to which the fusion promoting device 100 is attached as shown in FIG. Fixed. The deformation portion 40 can contact the shaft 310 in a state in which the height in the thickness direction is increased due to the increase in volume.

Next, the operator puts the living tissue on the mouth side A1 of the large intestine where the fusion promoting device 100 is placed into the body through the incision.

Next, the operator places the first engaging instrument 210 of the medical device 200 on the anal side A2 of the large intestine. As the first engaging device 210 is placed (inserted) on the anal side A2 of the large intestine, a through hole A21 is formed on the anal side A2 of the large intestine. The timing of forming the through hole A21 is not particularly limited as long as it is after the first engaging device 210 is arranged.

Next, the operator engages the shaft of the positioning part 230 and the shaft 310 of the second engaging device 270 at a spaced apart position while maintaining the state of holding the main body 10 against the mouth side A1 of the large intestine. Let Then, the rotating portion 261 is rotated to bring the first engaging device 210 and the second engaging device 270 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 relatively approach each other (S102).

Next, between the first engaging device 210 and the second engaging device 270, the operator moves around the mouth on the mouth side A1 of the large intestine, the main body 10 of the fusion promoting device 100, and the anus side A2 of the large intestine. The periphery of the through hole A21 formed in the intestinal wall is sandwiched (S103).

The operator rotates the handle 262 of the operating portion 260 of the medical device 200 around the rotating shaft 263 to protrude the annular blade of the punching portion 250 . Then, a portion of the mouth side A1 of the large intestine sandwiched between the first engaging device 210 and the second engaging device 270, a radially inner side of the main body 10, and a portion of the anal side A2 of the large intestine are excised. Then, the periphery of the excised portion is joined with staples (not shown) (S104).

Next, as shown in FIG. 11, the operator takes the medical device 200 out of the body, for example, from the anal side A2 of the large intestine through the anus. At this time, the region configured inside 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 device 200 . As a result, the portion of the fusion promoting device 100 located inside the punched portion 250 in the radial direction r is removed without remaining in the body.

The main body 10 of the fusion promoting device 100 is sandwiched and indwelled between the living organs to be joined, thereby promoting the fusion of the living organs to be joined through the through holes A21 of the main body 10.

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

As described above, the fusion promoting device 100 according to this embodiment includes the main body portion 10 and the deformation portion 40 . The main body 10 is arranged between living organs to be joined, and is configured in a sheet shape to promote the fusion of living tissues. The deformation portion 40 is provided adjacent to the main body portion 10 in the thickness direction of the main body portion 10, and is configured such that at least the inner side S1 is displaced inward in the plane direction YZ of the main body portion 10 due to an increase in volume. ing.

In addition, the medical instrument set 1 according to the present embodiment joins the above-described healing promotion device 100 to the first joint site and the second joint site, which are biological organs to be joined, and the fusion promotion device 100 is connected. A pinchable first engagement device 210 and a second engagement device 270 are provided. The second engaging device 270 engages with the first engaging device 210, is insertable through the hole portion 30 and the deformation portion 40 of the fusion promoting device 100, and contacts the inner side S1 displaced inward in the planar direction YZ. A contactable shaft 310 is provided.

With this configuration, the inner side S1 of the deformable portion 40 is displaced inward in a state in which the shaft 310 of the medical device 200 is inserted inside the fusion promoting device 100, thereby fixing the fusion promoting device 100 to the shaft 310. can do. This prevents or suppresses the displacement of the fusion promoting device 100 with respect to the living organ and prevents the device from falling off from the living organ during the procedure of joining the first site to be joined and the second site to be joined using the medical device 200. You can

In addition, since the deformation portion 40 is in a state in which the inner side S1 is not displaced inward before deformation, the body portion 10 can be easily inserted into the shaft 310 . As a result, it is possible to prevent or suppress damage or breakage of the fusion promoting device 100 when inserting the device 100 through the shaft 310 or the like.

The deformable portion 40 also comprises an enlarged portion 41 having a first internal space 42 capable of accommodating a volume-increasing fluid. As a result, by expanding the deformable portion 40 like a balloon, the fusion promoting device 100 is fixed to the shaft 310 to prevent or suppress displacement of the fusion promoting device 100 with respect to the living organ during a procedure, or to prevent or suppress displacement of the healing promoting device 100 from the living organ. It is possible to prevent falling off.

Further, the deformable portion 40 is provided on the outer surface of the expanded portion 41 and configured to include an injection portion 43 capable of circulating the fluid in the first internal space 42 . Accordingly, by connecting an inflator (not shown) to the injection section 43 and supplying fluid to the first internal space 42, the expansion section 41 can be expanded, and displacement of the fusion promoting device 100 with respect to the biological organ during the procedure can be prevented. It can be prevented or suppressed, or can be prevented from falling out of a living organ.

In addition, the deformation portion 40 is formed such that the inner side S1 is continuous in the circumferential direction θ. By configuring in this way, the fusion promoting device 100 having the deformable portion 40 can be easily fixed to the shaft 310, preventing or suppressing the displacement of the fusion promoting device 100 with respect to the living organ during a procedure, You can prevent it from falling off.

Further, the expanded portion 41 is configured so that the first dimension d1 in the thickness direction is larger than the second dimension d2 in the radial direction r in a state before the volume is increased. By configuring in this way, the inner side S1 of the deformation portion 40 can be easily displaced inward.

The healing device 100 also includes a hole 30 formed apart from the outer peripheral edge of the main body 10 in the plane direction YZ of the main body 10 . With this configuration, the shaft 310 of the medical device 200 can be easily inserted into the fusion promoting device 100 when fixing the device 100 to the shaft 310 of the medical device 200 .

<Modification 1>
12A and 12B are diagrams showing the arrangement of the body portion 10 and the deformation portion 40a in the fusion promoting device 100a according to Modification Example 1. FIG. In the first embodiment, the deformable portion 40 is arranged at a position different from that of the main body portion 10 in the thickness direction. However, if the fusion promoting device can be fixed to the shaft 310 of the second engagement device 270 when the deformed portion is expanded, it is arranged so as to overlap the body portion 10 in the axial direction X as shown in the deformed portion 40a in FIG. You may

In addition, in the fusion promoting device 100a in this modified example, the deformable portion 40a has the same configuration as the deformable portion 40 except that the position of the deformable portion 40a with respect to the main body portion 10 is different. are also the same as in the first embodiment. Therefore, the description is omitted.

<Modifications 2 and 3>
13 and 14 are diagrams showing attachment and detachment of the main body portion 10 and the deformation portion 40 of the fusion promoting devices 100b and 100c according to Modifications 2 and 3. FIG. In the first embodiment, the main body 10 is integrally formed with the deformation section 40. However, if the fusion promoting device can be fixed to the shaft 310 by the deformation section during the procedure, the following configuration is possible. . Note that the body portion 10, the reinforcing portion 20, the hole portion 30, and the deforming portion 40 in Modification Examples 2 and 3 are the same as those in the first embodiment, and therefore description thereof is omitted.

A healing promoting device 100b according to Modified Example 2 includes a body portion 10, a reinforcing portion 20, a hole portion 30, a deformation portion 40, and an engaging portion 50b, as shown in FIG. The engaging portion 50b includes a first engaging portion 51b and a second engaging portion 52b.

The first engaging portion 51 b is provided on the main body portion 10 and is configured to have a convex shape protruding toward the deformation portion 40 . The second engaging portion 52b is provided on the deformation portion 40 side, and is configured to have a concave portion that can be fitted with the convex shape of the first engaging portion 51b. As described above, in the device 100b for promoting healing, the convex shape of the first engaging portion 51b and the concave portion of the second engaging portion 52b are engaged with each other, and by releasing the engagement, the main body portion 10 is deformed. The part 40 can be attached and detached.

A healing promoting device 100c according to Modification 3 includes, as shown in FIG. 14, a body portion 10, a reinforcing portion 20, a hole portion 30, a deforming portion 40, and an engaging portion 50c. The engaging portion 50c can be configured to include a surface fastener or the like, and as an example, the first engaging portion 51c on the main body portion 10 side is a hook and the second engaging portion 52c on the deformation portion 40 side is a loop. Configurable.

Thereby, the deformation portion 40 can be attached and detached with respect to the main body portion 10 . Contrary to the above, the hook-and-loop fastener forming the engaging portion may be configured such that the loop is provided in the first engaging portion and the hook is provided in the second engaging portion.

In the fusion promoting devices 100b and 100c according to modified examples 2 and 3, the deformable portion 40 can be removed from the main body portion 10 by the engaging portions 50b and 50c. With this configuration, it is also possible to prevent or suppress displacement of the fusion promoting devices 100b and 100c with respect to the living organ during a procedure, or to prevent falling off from the living organ.

<Second embodiment>
FIG. 15 shows a fusion promoting device 100d according to the second embodiment. In the first embodiment, it has been described that the deformation section 40 is provided with a hole for the injection section 43 , and a tube or the like is connected to the injection section 43 to supply the fluid that expands the first internal space 42 . However, the deformation section can be configured as follows. Note that the body portion 10, the reinforcing portion 20, and the hole portion 30 in the healing promoting device 100d are the same as those in the first embodiment, and thus description thereof is omitted.

The deformation portion 40d includes an expansion portion 41, a first internal space 42, a fluid supply portion 44, a connection portion 45, and a second internal space 46, as shown in FIG. Since the expansion part 41 and the first internal space 42 are the same as those in the first embodiment, the description thereof is omitted.

The fluid supply portion 44 is configured to be connected to the extension portion 41 via the connection portion 45 . The fluid supply part 44 is internally provided with a second internal space 46 that communicates with the first internal space 42 via a connection part 45 . configured to contain similar fluids. The fluid supply part 44 is formed in a spherical shape in this embodiment.

The connecting portion 45 connects the fluid supply portion 44 and the extension portion 41 to allow communication between the second internal space 46 of the fluid supply portion 44 and the first internal space 42 of the extension portion 41 . Connection 45 may be configured to include flexible tubing, as an example. The connection portion 45 is configured integrally with the fluid supply portion 44 in this embodiment. However, as long as the second internal space 46 and the first internal space 42 can be communicated with each other, the connecting portion may be configured as a separate component instead of being integrated with the fluid supply portion.

In addition, the connecting portion 45 may be provided with a partition that can be opened and closed by the operation of the operator, or a check valve, so that the fluid does not flow back from the first internal space 42 to the second internal space 46 .

The treatment method using the fusion promoting device 100d differs from the first embodiment in that the fusion promoting device 100d is fixed to the shaft 310 by expanding the expanding portion 41 of the deformable portion 40d. Others are the same as those of the first embodiment, so descriptions of common matters are omitted.

When expanding the expanding portion 41 , the operator grips the outer surface of the fluid supply portion 44 with fingers and applies a pressing force so as to contract the elastically deformable fluid supply portion 44 .

As a result, the fluid contained in the second internal space 46 of the fluid supply portion 44 flows through the connection portion 45 into the first internal space 42 of the expanded portion 41, and the inner side S1 of the expanded portion 41 in particular moves inward in the radial direction r. is displaced to Thereby, the fusion promoting device 100d including the deformable portion 40d can be fixed to the shaft 310. As shown in FIG.

As described above, in this embodiment, the deformation portion 40d of the fusion promoting device 100d is connected to the expansion portion 41, communicates with the first internal space 42 of the expansion portion 41, and can accommodate the fluid to be circulated in the first internal space 42. a fluid supply 44 having a second internal space 46 therein. With this configuration, the fusion promoting device 100d is also fixed to the shaft 310 of the second engaging instrument 270, preventing or suppressing the displacement of the fusion promoting device 100d with respect to the living organ during a procedure, or preventing or suppressing the movement of the healing promoting device 100d from the living organ. It is possible to prevent falling off.

<Modification of Second Embodiment>
FIG. 16 is a diagram showing a deformed portion 40e of a healing promoting device 100e according to a modified example of the second embodiment. In the second embodiment, the spherical fluid supply portion 44 including the second internal space 46 capable of accommodating the fluid supplied by the deformation portion 40d to the expanded portion 41 can be communicated with the first internal space 42 and the second internal space 46. and the connection portion 45 that connects the extension portion 41 and the fluid supply portion 44 . However, the fluid supply section of the deformation section can be configured as follows.

As shown in FIG. 16, the fusion promoting device 100e includes a body portion 10, a reinforcing portion 20, a hole portion 30, and a deformation portion 40e. Since the main body portion 10, the reinforcing portion 20, and the hole portion 30 are the same as those in the second embodiment, description thereof is omitted.

The deformation portion 40e includes an expansion portion 41, a first internal space 42, a fluid supply portion 44e, a connection portion 45e, and a second internal space 46e. Since the expansion part 41 and the first internal space 42 are the same as those in the second embodiment, description thereof is omitted.

The fluid supply part 44e is configured to provide a second internal space 46e capable of containing the fluid to be circulated in the first internal space 42 of the expansion part 41, as in the second embodiment. The fluid supply portion 44e is formed in an annular shape like the extension portion 41 in this modified example.

The inner side S1 of the expansion portion 41 is displaced inward in the radial direction r and comes into contact with the shaft 310 when expanded as described above, while the fluid supply portion 44e does not come into contact with the shaft 310 even when expanded. You can configure the material and configure the dimensions. In this modified example, the fluid supply portion 44e is arranged so as to be spaced apart from the body portion 10 in the thickness direction more than the extension portion 41 is. However, the invention is not limited to this, and in addition to the above, the fluid supply portion may be disposed closer to the body portion 10 than the extension portion 41 in the thickness direction.

The connection portion 45e connects the fluid supply portion 44e and the expansion portion 41, and communicates the first internal space 42 and the second internal space 46e. In this modified example, the connecting portion 45e is arranged between the extension portion 41 and the fluid supply portion 44e in the thickness direction. However, as long as the first internal space and the second internal space can be communicated with each other, the connection portion does not necessarily have to be arranged between the extension portion and the fluid supply portion in the thickness direction. In addition, the connecting portion 45e may be provided with a partition that can be opened and closed by the operator's operation, or a check valve, so that the fluid does not flow back from the first internal space 42 to the second internal space 46.

The treatment method using the fusion promoting device 100e according to this modified example differs from that of the second embodiment in that the fusion promoting device 100e is fixed to the shaft 310 by expanding the expanded portion 41 of the deformable portion 40e. Others are the same as those of the second embodiment, so descriptions of common matters are omitted.

When grasping the outer surface of the fluid supply portion 44e with fingers, the operator presses one or more portions of the annular fluid supply portion 44e in the circumferential direction θ to expand the fluid present in the second internal space 46e. The first internal space 42 of the part 41 is made to circulate. By this operation, the second internal space 46e of the fluid supply portion 44e contracts, the fluid moves to the first internal space 42 by that amount, the first internal space 42 expands, and the inner side S1 comes into contact with the shaft 310. A fusion promoting device 100 e is secured to the shaft 310 .

As described above, in this modified example, the fluid supply portion 44e is configured in an annular shape so that the fluid can flow from the second internal space 46e to the first internal space 42 . With this configuration, the fusion promoting device 100e including the deformable portion 40e is also fixed to the shaft 310 to prevent or suppress the displacement of the fusion promoting device 100e with respect to the living organ during the procedure, or to prevent the device 100e from falling off from the living organ. can be prevented.

The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims.

In the first embodiment and the second embodiment, fluid is supplied to the first internal space of the expansion part that constitutes the deformation part, thereby expanding the first internal space and attaching the fusion promoting device including the deformation part to the shaft 310 . I explained that it was fixed.

However, the specific configuration of the deformable portion is not limited to the above, as long as the deformable portion and the shaft can be brought into contact with each other due to the increase in volume. In addition to supplying the fluid to the first internal space, the deformable portion causes a gas generator (not shown) to generate fluid triggered by application of heat such as ignition, and supplies the fluid to the first internal space of the deformable portion. to increase the volume of the deformed portion.

More specifically, heat can be applied to a gas generator provided separately from the deformation section using an electric scalpel or the like to generate fluid, and the gas can be configured to flow through the first internal space of the deformation section. In another example, the deformable portion comprises a temperature-sensitive polymer, and contact of the deformable portion with a patient's bodily organ causes heat to be imparted from the bodily organ so that the inside of the deformable portion contacts the shaft. Alternatively, the volume of the deformed portion may be increased.

With this configuration as well, the fusion promoting device can be fixed to the shaft to prevent or suppress displacement of the fusion promoting device with respect to the biological organ during a procedure, or to prevent the device from coming off.

In addition, the trigger for expanding the deformed portion is not limited to the application of heat. can be configured to In addition to the above, the volume of the deformation portion may be increased during a phase change, such as dry ice, in which a solid changes to a gas. Further, the deformable portion may be configured such that aerobic bacteria are arranged in the first internal space, gas is generated by fermentation of the aerobic bacteria, and the volume of the deformable portion is increased.

Further, in the first embodiment, the deformable portion 40 is configured in an annular shape so as to surround the shaft 310 . However, if the fusion promoting device can be fixed to the shaft when the deformable portion is deformed and the inner side of the deformable portion is displaced inward in the radial direction r, the deformable portion surrounds the shaft but is connected all the way around like a C. It may be a shape that does not have a shape. In this case, the C-shaped deformed portion may be configured such that the ends of the C-shaped deformation in the circumferential direction are connected by another thread-like member or the like.

Further, it has been described that the hole 30 is pre-formed in the fusion promoting device prior to the procedure. However, as long as the shaft of the second engagement instrument can be passed through the fusion promoting device, the hole does not have to be pre-formed before the procedure, and may be formed during the procedure. In addition, the fusion promoting device need not include the reinforcing portion 20 as long as it includes the main body portion and the deformation portion.

In addition, in the modifications 2 and 3, the configuration for making the main body and the deformable part detachable has been described by exemplifying the concave-convex fitting and the hook-and-loop fastener. You may comprise so that a deformation|transformation part may be attached or detached. Further, second engagement instrument 270 of medical device 200 has been described as shaft 310 comprising first shaft 311 and second shaft 312 having different diameters. However, the shaft of the second engaging device is not limited to the above, and may be configured with a cylindrical shape or the like having a single diameter.

1 medical instrument set,
10 main body,
30 holes,
40, 40a, 40d, 40e deformed portion,
41 extensions,
42 first interior space,
43 injection part 44 fluid supply part,
46 second interior space,
100, 100a, 100b, 100c, 100d, 100e adhesion promoting device,
200 medical devices;
210 first engagement device;
270 second engagement device;
310 shaft,
S1 inside,
d1 first dimension,
d2 second dimension,
X-axis direction (thickness direction of the adhesion promoting device),
YZ plane direction.

Claims (10)

a sheet-like main body that is placed between living organs to be joined and promotes fusion of living tissues;
and a deformable portion that is provided adjacent to the body portion in the thickness direction of the body portion and that at least the inner side is displaced inward in the surface direction of the body portion due to an increase in volume. 2. A healing promoting device according to claim 1, wherein the deformable portion comprises an extension portion having a first interior space capable of accommodating the volume-increasing fluid. 3. The healing promoting device according to claim 2, wherein the deformation section includes an injection section provided on the outer surface of the extension section and capable of circulating the fluid in the first internal space. 3. The fluid supply unit according to claim 2, further comprising a fluid supply unit connected to the expansion part and provided with a second internal space that communicates with the first internal space of the expansion part and can accommodate the fluid that is to be circulated in the first internal space. A fusion promoting device as described. The healing promoting device according to any one of claims 2 to 4, wherein the expansion part supplies the fluid to the first internal space by applying heat. The fusion promoting device according to any one of claims 2 to 5, wherein the extension part is formed so that the inner side is connected all the way around. The fusion promoting device according to any one of claims 2 to 6, wherein the first dimension in the thickness direction of the expanded portion is larger than the second dimension in the radial direction before the volume is increased. The fusion promoting device according to any one of claims 1 to 7, wherein the deformable portion is removable with respect to the body portion. The healing promoting device according to any one of claims 1 to 8, further comprising a hole formed apart from the outer peripheral edge of the main body in the surface direction of the main body. A fusion promoting device according to any one of claims 1 to 9;
A medical device comprising a first engaging device and a second engaging device that join one site to be joined and the other site to be joined, which are the living organs to be joined, and can sandwich the fusion promoting device. and
The second engaging device engages with the first engaging device, and has a shaft that can be inserted through the deformable portion of the fusion promoting device and can come into contact with the inner side displaced inward in the planar direction. A set of medical instruments to prepare.

Images