JP7797285B2 - Medical Devices - Google Patents

Description

The present invention relates to a medical device.

In the medical field, surgical procedures for joining biological organs (e.g., gastrointestinal anastomosis) are known. When such procedures are performed, it is known that an important factor in determining postoperative prognosis is whether or not there is a delay in healing at the junction where the biological organs are joined.

Various methods and medical devices are used in procedures for anastomosis of biological organs. For example, methods have been proposed that use biodegradable sutures to suture biological organs, or mechanical anastomosis devices that perform anastomosis using staples. In particular, when performing anastomosis using a mechanical anastomosis device, the joining strength between biological organs at the joint can be increased compared to methods using sutures, thereby reducing the risk of anastomotic failure.

Special Publication No. 2007-505708

The anastomosis device of Patent Document 1 promotes healing of the anastomotic site by sandwiching a sheet-like member (hereinafter referred to as a sheet-like device) such as a support structure to prevent leakage or tearing at the anastomotic site. Such sheet-like devices are typically relatively thin and soft. A portion of the above-mentioned sheet-like device is removed using a stapler such as that described in Patent Document 1, leaving behind the portion necessary for anastomosis. The operation of removing a portion of the sheet-like device is sometimes called punching. The inventors have noted that due to the softness and other properties of the above-mentioned sheet-like device, there are cases where the stapler is unable to properly punch through the sheet-like member when performing a punching operation on the sheet-like device.

The present invention was made to solve the above-mentioned problems, and aims to enable medical instruments such as staplers to be smoothly removed from the body even when it is difficult to punch through a sheet-shaped medical device.

One aspect of the present invention is a medical device having a main body portion and a detachable portion. The main body portion is capable of being placed at an anastomosis site of a biological organ, and at least a portion thereof is configured in a sheet-like shape and contains a bioabsorbable material. The detachable portion is configured integrally with the main body portion at the center thereof and is detachable from the main body portion when an external force is applied.

The medical device according to one aspect of the present invention allows for the smooth removal of a medical instrument such as a stapler from the body even when it is difficult to punch through a sheet-like medical device.

10 is a schematic diagram showing the state in which the medical device according to the first embodiment is inserted onto the shaft of a second engaging instrument of a medical instrument used for anastomosis. FIG. 10A and 10B show through holes in the body of the medical device. 2 illustrates a medical device including the second engagement device shown in FIG. 1. 10A and 10B are views showing the state in which the shaft of the positioning portion of the first engaging device of the medical device is engaged with the shaft of the second engaging device. 10 is a flowchart showing a method of using the medical device according to the first embodiment. 10 is a flowchart showing an example of use of the medical device (colorectal anastomosis). 10A and 10B are views showing the state in which the shaft of the positioning portion of the first engaging device of the medical device is engaged with the shaft of the second engaging device. 10 is a diagram showing a state in which a medical device is sandwiched together with a biological organ by a first engaging tool and a second engaging tool. FIG. FIG. 1 is a diagram showing an anastomosis of a living organ. 10A and 10B are views showing the state in which the medical device according to the first embodiment is inserted onto the shaft of the second engagement tool. 10A and 10B are diagrams showing how the main body of the medical device is pulled. FIG. 10 is a view showing the state in which the main body portion of the medical device is separated from the separation portion. FIG. 10 is a plan view showing a medical device according to a first modified example of the first embodiment. FIG. 10 is a plan view showing a fixing portion and a hole portion of a medical device according to a second modification of the first embodiment. FIG. 10 is a cross-sectional view of a medical device according to a second embodiment taken along the axial direction, passing through the center of the main body. FIG. 10 is an exploded view showing a medical device according to a second embodiment. 10A and 10B are views showing the state in which the medical device according to the second embodiment is inserted onto the shaft of the second engagement tool. 10A and 10B are views showing the state in which the medical device according to the second embodiment is inserted onto the shaft of the second engagement tool. 10A and 10B are diagrams showing how the main body of the medical device according to the second embodiment is pulled. 10A and 10B are views showing how the main body of the medical device according to the second embodiment is separated from the separation part. FIG. 10 is a schematic perspective view showing a medical device according to a third embodiment. FIG. 11 is a perspective view showing a state in which the main body portion is clamped by the separating portion of the medical device according to the third embodiment. FIG. 11 is a perspective view showing a state in which the clamping of the main body portion by the separating portion of the medical device according to the third embodiment is released. FIG. 10 is a cross-sectional view along the axial direction taken along the center of a medical device according to a third embodiment. FIG. 13 is a perspective view showing a medical device according to a first modified example of the third embodiment. FIG. 26 is a perspective view showing a medical device according to a first modification of the third embodiment, viewed from a different direction from that shown in FIG. 25 . FIG. 13 is a perspective view showing a medical device according to a second modification of the third embodiment. FIG. 28 is a perspective view showing a medical device according to a second modification of the third embodiment, viewed from a different direction from that shown in FIG. 27. FIG. 10 is a view showing a state in which the main body is clamped by the separation parts that constitute the medical device according to the fourth embodiment. FIG. 11 is a view showing a state in which the clamping of the main body part by the separation part is released in the medical device according to the fourth embodiment.

The following describes in detail the embodiments of the present invention with reference to the drawings. The embodiments shown here are illustrative examples that embody the technical concepts of the present invention and are not intended to limit the scope of the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, as well as within the scope of the inventions set forth in the claims and their equivalents.

Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically and with scale, aspect ratio, shape, etc., appropriately altered from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

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

In the following, a coordinate system is shown in the drawings. X in the Cartesian coordinate system is along the axial or thickness direction of the main body 10 that constitutes the medical device 100, and is referred to as the axial direction X. Y and Z are planes that intersect with the axial direction X, and are referred to as the planar directions YZ.

In the cylindrical coordinate system, r is the direction extending radially or radiating from the center of the main body 10 of the medical device 100 along the planar direction YZ, and is referred to as the radial direction r. θ is the direction extending circumferentially or angularly from the center of the main body 10 in the planar direction YZ, which intersects with the axial direction X of the main body 10, and is referred to as the circumferential direction θ.

First Embodiment
Fig. 1 is a diagram showing a state in which a medical device 100 according to the first embodiment is inserted onto a shaft 310 of a second engaging instrument 270 of a medical instrument 200, and Fig. 2 is a diagram showing a through-hole 11 of the medical device 100. Fig. 3 is a diagram showing the medical instrument 200. Fig. 4 is a diagram showing the distal end of a first engaging instrument 210 and a second engaging instrument 270 which constitute the medical instrument 200.

Figures 5 to 12 are diagrams illustrating a procedure for performing anastomosis of the digestive tract, using the large intestine as an example, using the medical device 100.

As shown in Figures 5 to 12, the medical device 100 can be applied to procedures for joining specific biological organs together (for example, gastrointestinal anastomosis). As will be described later, this specification will explain colon anastomosis as an example of a procedure using the medical device 100, but the area in which the healing promotion device of the present invention can be used is not limited to the large intestine.

Before explaining the medical device 100, we will explain the medical instrument 200.

<Medical Instrument 200>
The medical instrument 200 joins one portion to be joined (first portion to be joined), which is a biological organ in biological tissue, to another portion to be joined (second portion to be joined) facing the first portion to be joined. The medical instrument 200 includes a first engaging instrument 210 and a second engaging instrument 270 that can clamp the medical device 100 via the first portion to be joined and the second portion to be joined. The medical instrument 200 may be called a circular stapler. The configuration of each part will be described below.

As shown in Figure 8, etc., the first engaging tool 210 is placed on one side of the medical device 100 when anastomosing the medical device 100 to biological tissue. The first engaging tool 210 is configured to be able to abut against the first joining site.

The second engaging instrument 270 is positioned on the opposite side of the medical device 100 from the first engaging instrument 210 during anastomosis, and is configured to be able to abut against the second site to be joined. Details will be provided below. The first engaging instrument 210 may be referred to as a trocar, and the second engaging instrument 270 may be referred to as an anvil. These will be described in more detail below.

<First Engagement Device>
As shown in FIGS. 3 and 4 , 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 .

The elongated member 220 corresponds to the main body of the first engaging device 210. As shown in Figure 4, the elongated member 220 has a space S at its longitudinal tip, through which the shaft of the positioning portion 230 can move relatively forward and backward. The cross section of the elongated member 220 intersecting the axial direction is configured to be hollow and circular.

In this embodiment, the elongated member 220 extends linearly in the longitudinal direction and has bent portions, but the elongated member does not need to have bent portions as long as it can achieve the anastomosis and punching functions described below.

The positioning unit 230 has an elongated shaft. As shown in Figure 4, the shaft of the positioning unit 230 is configured to be movable relatively forward and backward from the space S at the longitudinal tip of the elongated member 220. The positioning unit 230 is configured to be insertable into a hole Pt that may be formed approximately in the center of the medical device 100 and into the inner cavity of the shaft 310 of the second engaging instrument 270, which will be described later. The first engaging instrument 210 and the second engaging instrument 270 are configured to be connectable by assembling the shaft of the positioning unit 230 and the shaft 310.

The release section 240 is configured to release multiple staples in a generally annular shape to join the first and second joined portions. The release section 240 is formed in a generally circular disk shape at the tip end of the elongated member 220 in the longitudinal direction. The release section 240 is configured by providing multiple staple release points along the circumferential direction at the tip of the elongated member 220.

The punching section 250 is positioned radially inward of the discharge section 240 at the tip of the elongated member 220 and is configured to punch out the radially inward portions of the first and second joined sections. As shown in Figure 4, the punching section 250 is configured to have an annular blade that punches out the first and second joined sections radially inward of the discharge section 240. The shape of the punching section 250 can be configured to be a perfect circle when viewed in a plan view from the longitudinal direction, but the shape of the punching section 250 may be elliptical or other, as long as it punches out portions not necessary for promoting healing.

The operating unit 260 is configured to operate the positioning unit 230, the ejection unit 240, and the punching unit 250. As shown in Figure 3, the operating unit 260 includes a rotating unit 261 and a handle 262.

The rotating unit 261 is provided at the base end (base end side) in the longitudinal direction of the elongated member 220. The rotating unit 261 is configured to be rotatable relative to the elongated member 220, with the longitudinal direction at the base end side of the elongated member 220 serving as the rotation axis. The rotating unit 261 is configured so that, when the second engaging device 270 is engaged with the first engaging device 210, the first engaging device 210 and the second engaging device 270 can be moved relatively closer or farther apart by rotating relative to the elongated member 220.

The handle 262 is configured to be gripped by the user together with the base end (proximal end side) of the elongated member 220. The handle 262 is rotatably connected to the elongated member 220 by a rotation shaft 263. When gripped by the user, the handle 262 rotates around the rotation shaft 263 and moves relatively closer to the elongated member 220. This allows staples to be released from the release section 240 and the annular blade of the punching section 250 to protrude from the tip of the elongated member 220.

<Second Engagement Device>
The second engaging tool 270 is configured to be able to clamp the medical device 100 together with the first engaging tool 210 via the first and second to-be-joined portions. The second engaging tool 270 includes a head 280, an abutment portion 290, and a shaft 310, as shown in FIG.

The head 280 is positioned adjacent to the elongated member 220 of the first engaging device 210, particularly the distal end thereof, when the first engaging device 210 and the second engaging device 270 are engaged. In this embodiment, the head 280 is configured in a generally circular disk shape as shown in Figures 3 and 4, and its cross-sectional shape is configured to be the same as or similar to the circular shape of the elongated member 220.

The abutment portion 290 corresponds to the first engaging device 210 side of the head 280 and is configured to be able to abut against multiple staples discharged from the discharge portion 240. The staples discharged from the discharge portion 240 abut against the abutment portion 290 and deform, thereby joining the first and second joined portions.

The shaft 310 is configured to be able to pass through a hole Pt formed in the approximate center of the medical device 100 (described below). The shaft 310 is configured to be able to engage with the shaft of the positioning portion 230 of the first engagement instrument 210.

The shaft 310 has a space for accommodating the shaft of the positioning portion 230 of the first engagement device 210. The shaft 310 has a mechanism that allows it to be aligned with the shaft of the positioning portion 230. In this embodiment, the mechanism for aligning the shaft 310 with the shaft of the positioning portion 230 is configured to include a protrusion 311 that can move (protrude) radially from the cylindrical shape of the shaft 310, as shown in Figure 4, etc.

<Medical device 100>
The medical device 100 is placed between biological organs to be anastomosed, and is flat with a plurality of through-holes 11. As shown in FIG. 1 etc., the medical device 100 includes a main body portion 10, a reinforcing portion 20, a fixing portion 30, a hole portion Pr, and a separation portion 40.

<Main body>
The main body 10 is arranged between the biological organs to be anastomosed and is configured in a sheet shape that can follow the movements of the biological organs to be anastomosed.

The main body 10 is formed, for example, in a circular shape, and has a plurality of through holes 11 formed to pass through the circular shape in the thickness direction (axial direction X) as shown in Figure 2. The size of the through holes 11 in the main body 10 is preferably 0.1 to 6 mm, more preferably 0.3 to 4 mm, and even more preferably 0.6 to 1.5 mm. The main body 10 can be configured so that the ratio of the dimension D of the through holes 11 to the pitch P is 0.25 or greater and less than 40. Note that the (perfect) circle described as the shape of the main body 10 is an example, and other shapes such as an ellipse, a polygon such as a rectangle, or a star may also be used.

The thickness of the main body 10 (dimension T shown in Figure 2) is not particularly limited, but is preferably 0.05 to 0.3 mm, and more preferably 0.1 to 0.2 mm.

The main body 10 can be made of a biodegradable material (bioabsorbable material). There are no particular restrictions on the material from which the main body 10 can be made, and examples include biodegradable resins.

Specific examples include: (1) polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphate esters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose; and (2) copolymers composed of one or more of the monomers constituting (1) above.

In other words, the biodegradable sheet preferably contains at least one biodegradable resin selected from the group consisting of polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphate esters, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose, as well as copolymers composed of one or more monomers that constitute the aforementioned polymers.

The method for manufacturing the main body 10 is not particularly limited, but examples include a method of manufacturing fibers made from the biodegradable resin described above and using the fibers to manufacture a mesh-shaped sheet. The method for manufacturing fibers made from a biodegradable resin is not particularly limited, but examples include electrospinning (electric field spinning/electrostatic spinning) and melt-blowing. The main body 10 may be manufactured using only one of the above methods, or two or more may be selected and combined as appropriate. Further examples of the method for manufacturing the main body 10 include a method of spinning fibers made from the biodegradable resin described above using a conventional method and weaving the resulting fibers into a mesh to manufacture the biodegradable sheet of the present invention; a method of compressing the fibers to manufacture the biodegradable sheet; and a method of intertwining the fibers without weaving them to manufacture the biodegradable sheet.

The main body 10 induces a biological reaction through the constituent materials, such as biodegradable resin, that make up the main body 10. Through this action, the main body 10 induces the expression of biological components such as fibrin. The biological components induced in this manner can penetrate the through-holes 11 of the main body 10 and accumulate, promoting fusion. Therefore, by placing the main body 10 of the medical device 100 between the biological organs to be joined, fusion is promoted through the above mechanism.

<Reinforcement part>
The reinforcing portion 20 is provided to prevent twisting, shifting, breakage, etc. of the medical device 100 when, for example, the medical device 100 is placed between the first and second bonded portions by the medical instrument 200. The reinforcing portion 20 is formed along the outer periphery of the hollow circular shape of the main body portion 10.

In this embodiment, the reinforcing portion 20 is configured to have higher rigidity than the main body portion 10. The reinforcing portion 20 is located on the opposite side of the main body portion 10 from the separating portion 40 in the radial direction r, and is configured to be harder than the main body portion 10.

In this embodiment, the reinforcing portion 20 is configured in a shape that does not include through holes 11 in the main body portion 10. However, as long as it facilitates deployment of the main body portion 10 and maintains the deployed state, the specific shape of the reinforcing portion 20 is not limited to the above, and its position does not have to be on the outer periphery, but may be near the edge, etc. The reinforcing portion 20 is preferably made of a bioabsorbable material such as a thermoplastic resin, such as PGA (polyglycolic acid), PLA (polylactic acid), PLGA (polylactic-co-glycolic acid), PDS (polydioxanone), or PCL (polycaprolactone).

The reinforcing portion 20 may contain a non-bioabsorbable material. The reinforcing portion 20 may be provided around the entire circumference of the outer surface of the main body portion 10, or multiple reinforcing portions 20 may be provided dispersedly around the entire circumference. The reinforcing portion 20 may be bonded to the main body portion 10 with adhesive or heat fusion, or may be sewn to the main body portion 10 with thread.

<Fixed part>
The fixing portion 30 is provided to prevent or inhibit displacement of the medical device 100 and to prevent it from falling off when, for example, the medical device 100 is placed between the first and second bonded portions by the medical instrument 200. The fixing portion 30 is formed along the inner periphery of the hollow circular shape of the main body portion 10.

Like the reinforcing part 20, the fixing part 30 is configured in a shape that does not have a through-hole 11 in the main body part 10. However, the specific shape of the fixing part 30 is not limited to the above, as long as it facilitates the deployment of the main body part 10 and maintains the deployed state. The fixing part 30 can be configured from the same material as the reinforcing part 20.

The fixing portion 30 may be provided around the entire circumference of the inside of the main body portion 10, or it may be provided partially around the entire circumference. Furthermore, the fixing portion 30 is configured coaxially with the inner edge, but its center may be offset from the main body portion 10 as long as it does not enter the fusion region.

<Hole>
The hole Pr is spaced apart from the outer peripheral edge of the main body 10 in the planar direction YZ of the main body 10, and in this embodiment is formed by the fixing part 30. The hole Pr is configured so that the shaft 310 of the medical device 200 can be inserted therethrough. The hole Pr is configured so that it is larger than the shaft 310 of the second engaging device 270 when the shaft 310 is attached. In this embodiment, the hole Pr is configured to have a substantially circular shape when viewed in the axial direction X.

<Separation part>
The separation part 40 is integrally formed with the main body part at the center thereof and is configured to be separable from the main body part by application of an external force. In this embodiment, the separation part 40 includes a first member 41, a second member 42, and a connecting part 43, as shown in FIG.

The first member 41 is disposed on one side of the main body 10 in the axial direction X of the main body 10. The second member 42 is configured to be disposed on the opposite side of the first member 41, sandwiching the main body 10 in the axial direction X of the main body 10. The first member 41 and the second member 42 are configured to hold the main body 10 between them and become one unit until punching by the punching unit 250. In this specification, the state in which the first member 41 and the second member 42 are spaced apart from the main body 10 in the axial direction X to the extent that the main body 10 can remain integrated until the punching operation is performed is referred to as the first member 41 and the second member 42 sandwiching the main body 10.

The first member 41 and the second member 42 can be formed so that their outer dimensions when viewed in a plan view are larger than the hole Pr of the main body 10, as shown in Figure 1. This allows the main body 10 to be integral with the separation portion 40 until an external force is applied and the main body 10 is separated from the separation portion 40 by the surgeon's operation. Furthermore, the outer dimensions of the first member 41 and the second member 42 are configured to be equal to or smaller than the inner diameter of the punching portion 250 so that they can be removed into the body by the punching portion 250.

The connecting portion 43 is configured to integrally connect the first member 41 and the second member 42 so as to leave a gap between them in the axial direction X. The first member 41, the second member 42, and the connecting portion 43 preferably include an elastically deformable material so that the main body portion 10 can be easily separated from the separation portion 40 when an external force is applied. Furthermore, the first member 41 and the second member 42 can be configured to include a material that is harder than the main body portion 10.

The connecting portion 43 is configured to have a cylindrical shape that integrally connects the first member 41 and the second member 42 to a degree that prevents the main body 10 from falling off. The first member 41 and the second member 42 are configured to be spaced apart in the axial direction X by a distance equal to or greater than the thickness of the main body 10, so that the main body 10 can be easily separated when an external force is applied (see Figure 1). If the distance between the first member 41 and the second member 42 is too small, the main body 10 may be difficult to separate from the separation portion 40. However, if the surfaces of the first member 41 and the second member 42 facing the main body 10 are smooth, the main body 10 can be more easily separated from the separation portion 40 even if the distance is less than the thickness of the main body 10. On the other hand, if the distance between the first member 41 and the second member 42 is too large, the main body 10 may not be held and may easily fall off midway. Therefore, it is preferable that the distance between the first member 41 and the second member 42 be approximately 0.8 to 3 times the thickness of the main body 10.

The connecting portion 43 is configured to connect the first member 41 and the second member 42 so that when the main body 10 is inserted onto the shaft 310 of the second engagement device 270, the height of the first member 41 and the second member 42 in the axial direction X is such that they do not come into contact with the protrusion 311 (see FIG. 1). The connecting portion 43 has a hole Pt that allows the shaft 310 to be inserted therethrough. The hole Pt is configured to have a smaller dimension in the radial direction r than the hole Pr. In this embodiment, the hole Pt is configured to have an approximately circular shape when viewed in the axial direction X, for example.

<Treatment method>
Next, a description will be given of a treatment method using the medical device 100. Fig. 5 is a flowchart showing each step of the treatment method using the medical device 100.

The treatment method includes (S11) placing a medical device 100 having a sheet-like main body 10 that promotes healing of biological tissues between a first to-be-joined portion on one side and a second to-be-joined portion on the other side, as shown in Figure 5. The treatment method also includes (S12) joining the first to-be-joined portion on one side and the second to-be-joined portion on the other side, with at least a portion of the main body 10 of the medical device 100 placed between the first to-be-joined portion on one side and the second to-be-joined portion on the other side.

The biological organs to be joined by the treatment method and the areas of the biological organs to be joined are not particularly limited and can be selected arbitrarily. However, the following explanation will use colorectal anastomosis as an example. Furthermore, detailed explanations of known procedural procedures and known joining devices for each procedure described below will be omitted where appropriate.

Hereinafter, in the description of this specification, "placing a medical device between biological organs (hereinafter referred to as the above description)" can mean that the medical device is placed in direct or indirect contact with the biological organ.

The above description can also mean that the medical device is placed with a spatial gap formed between it and the biological organ. The above description can also mean that the medical device is placed in both of these states (for example, the medical device is placed in contact with one biological organ and not in contact with the other biological organ).

In addition, in the explanations herein, "periphery" does not specify a strict range (area), but rather refers to a predetermined range (area) as long as the purpose of the treatment (joining of living organs) can be achieved.

The order of the procedural steps described in each treatment method can be changed as appropriate, as long as the purpose of the treatment can be achieved. In addition, in this specification, "relatively approaching" means both bringing two or more objects closer together, and bringing only one object closer to the other.

Figure 6 is a flowchart showing the steps of an embodiment of the treatment method (colonic anastomosis). Figures 7 to 12 are diagrams used to explain colonic anastomosis.

In the treatment method according to this embodiment, the biological organ to be joined is the large intestine that has been cut in conjunction with the resection of a cancerous tumor. Specifically, the biological organ to be joined is the oral side A1 of the cut large intestine and the anal side A2 of the cut large intestine. The following explains the procedure for joining a portion of the intestinal wall on the oral side A1 of the cut large intestine (one of the areas to be joined) and a portion of the intestinal wall on the anal side A2 of the cut large intestine (the other area to be joined).

As shown in FIG. 6 , the treatment method according to this embodiment includes placing the medical device 100 between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S101), and bringing the oral side A1 of the large intestine and the anal side A2 of the large intestine relatively close together (S102). The treatment method also includes sandwiching the main body 10 of the medical device 100 between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S103), and joining the main body 10 of the medical device 100 sandwiched between the oral side A1 of the large intestine and the anal side A2 of the large intestine (S104). This is described in more detail below.

First, the surgeon prepares the medical device 200, creates a hole-like area called a port around the navel, and inflates the patient's abdomen.

Next, the surgeon makes an incision (not shown) around the navel and uses a medical instrument called a linear stapler to resect the affected area of the colon, such as cancer, and the cut portion of the colon is automatically sutured with a stapler. In this state, the colon is separated into an oral side A1 and an anal side A2. The surgeon then removes the oral side A1 of the colon from the body through the incision and inserts the second engaging instrument 270 of the medical instrument 200 into the oral side A1 of the colon. The surgeon inserts the second engaging instrument 270 into the oral side A1 of the colon and performs a purse-string suture with the shaft 310 protruding, forming the sutured portion A11. The outer surface of the sutured portion A11 becomes partially protruding toward the convex side as a result of the suturing (see Figure 7).

Next, as shown in Figure 10, the surgeon inserts the shaft 310 of the second engagement instrument 270 through the hole Pr located approximately in the center of the main body 10 and the hole Pt of the separation part 40. By clamping the main body 10 with the separation part 40, which has the hole Pt, the main body 10 is held and fixed so that it does not move from the suture part A11, thereby preventing the main body 10 from shifting or falling off the living organ.

Next, the surgeon places the biological tissue on the oral side A1 of the large intestine where the medical device 100 is placed into the abdominal cavity through the incision. Next, the surgeon uses forceps or the like to bring the tip of the second engagement tool 270 close to the anal side A2.

Next, the surgeon inserts the first engaging instrument 210 through the anus, thereby placing the first engaging instrument 210 of the medical instrument 200 on the anal side A2 of the large intestine. As the first engaging instrument 210 is placed (inserted) on the anal side A2 of the large intestine, the positioning portion 230 (shaft) of the first engaging instrument 210 penetrates the sutured portion A11 near the anal side A2 of the large intestine, forming a through-hole A21 on the anal side A2 of the large intestine. Note that there are no particular limitations on the timing of forming the through-hole A21, as long as it is done before the first engaging instrument 210 is placed.

Next, while maintaining the state in which the main body unit 10 is held against the oral side A1 of the large intestine, the surgeon engages the positioning unit 230 with the shaft 310 of the second engaging instrument 270 in a spaced-apart position (S101). Then, the rotating unit 261 is rotated to bring the first engaging instrument 210 and the second engaging instrument 270 relatively closer together, as shown in Figure 8 (S102). This brings the area around the oral part of the large intestine and the wall of the large intestine relatively closer together.

Next, the surgeon clamps the intestinal wall on the oral side A1 of the large intestine, the main body 10 and separation section 40 of the medical device 100, and the area around the through-hole A21 formed in the intestinal wall on the anal side A2 of the large intestine between the first engaging tool 210 and the second engaging tool 270 (S103).

The surgeon rotates the handle 262 of the operating unit 260 of the medical instrument 200 around the rotation axis 263 to protrude the annular blade of the punching unit 250. The surgeon then resects a portion of the oral side A1 of the large intestine that is sandwiched between the first engaging instrument 210 and the second engaging instrument 270, the inner side in the radial direction r of the main body unit 10, and a portion of the anal side A2 of the large intestine, and joins the periphery of the resected area in a substantially annular shape with staples (not shown) (S104).

Next, as shown in Figure 9, the surgeon removes the medical instrument 200 from the anal side A2 of the large intestine, for example, via the anus, to the outside of the living body. At this time, the region of the first engaging instrument 210 located inward of the outer diameter d of the punched portion 250 is removed together with the medical instrument 200. As a result, the portion of the medical device 100 located inward of the punched portion 250 in the radial direction r is removed without remaining in the body. Note that if the main body portion 10 and the reinforcing portion 20 are not made of a bioabsorbable material, the portions of the main body portion 10 and the reinforcing portion 20 that should not be left in the living body are removed from the port described above.

In this embodiment, the main body 10 is configured to be easily separated from the separation part 40 when an external force is applied to the main body 10 by the punching part 250. Therefore, if the blade of the punching part 250 comes into contact with the main body 10 and the main body 10 cannot be properly punched out as shown in Figure 9, the separation part 40 remains integrated with the shaft 310, while the main body 10 is pushed (pulled) by the punching part 250 (see Figure 11).

As a result, as shown in FIG. 12, the main body portion 10 can be separated from between the first member 41 and the second member 42 of the separation unit 40. This prevents the medical instrument 200 from becoming unable to be removed from the biological organ, even if the main body portion 10 is not successfully punched out by the punching unit 250. Furthermore, because the medical device 100 has a hole Pr, even if fraying occurs in the main body portion 10, the second engaging instrument 270 and the like can be removed from the anastomosis site through the hole Pr.

By sandwiching and placing the main body 10 of the medical device 100 between the biological organs to be joined, healing of the biological organs to be joined can be promoted through the through-hole 11 or the main body 10 located radially outward from the punched portion 250 of the main body 10.

This treatment method reduces the risk of suture failure after a joining procedure (e.g., gastrointestinal anastomosis) by simply sandwiching the sheet-like main body 10 between the first and second joining sites.

As described above, the medical device 100 according to this embodiment comprises a main body portion 10 and a detachable portion 40. The main body portion 10 is capable of being placed at an anastomosis site of a biological organ, contains at least a portion of a bioabsorbable material, and is formed in a sheet shape. The detachable portion 40 is configured integrally with the main body portion 10 at the center thereof, and is configured to be detachable from the main body portion 10 when an external force is applied.

When punching out the main body portion 10 with the punching portion 250 of the medical instrument 200, it is possible that fraying or other damage may occur in the main body portion 10, resulting in damage to the main body portion 10 or preventing smooth removal of the medical instrument 200 following punching. In response to this, by providing the medical device 100 with a separation portion 40, even if the punching operation is not performed properly, excessive stress on the main body portion 10 that is to be placed in the body can be prevented or reduced. It can also prevent the medical instrument 200 from being unable to be removed from the body due to improper punching of the main body portion 10 during punching. Furthermore, the separation portion 40 prevents the main body portion 10 from shifting or falling off relative to the second engaging instrument 270 until the main body portion 10 is punched out by the punching portion 250.

The separation unit 40 also includes a first member 41 arranged on one side of the main body unit 10 in the axial direction X of the main body unit 10, a second member 42 arranged on the opposite side of the main body unit 10 from the first member 41, and a connecting unit 43. The connecting unit 43 connects the first member 41 and the second member 42 so that the distance between the first member 41 and the second member 42 in the axial direction X is greater than the thickness of the main body unit 10. This configuration makes it easier to separate the main body unit 10 from the separation unit 40 when the punching operation of the punching unit 250 on the main body unit 10 is not successful, allowing the medical device 200 to be smoothly removed from the body.

Furthermore, the size of the outer periphery of the first member 41 and the second member 42 is configured to be equal to or larger than the size of the hole Pr. By configuring it in this manner, the main body 10 can be maintained integral with the separation portion 40 until an external force is applied to separate the main body 10 from the separation portion 40.

The main body 10 also has multiple through-holes 11. When the main body 10 is applied to the anastomosis of a biological organ, biological components of the biological organ penetrate the through-holes 11 of the main body 10 and accumulate there, promoting healing of the anastomosis. This configuration can promote joining of the anastomosis.

In addition, the inner peripheral edge of the main body 10, which corresponds to the fixing portion 30, is configured to be larger than the shaft 310 of the second engaging instrument 270 when the shaft 310 is attached. This configuration allows the medical device 100 to be quickly inserted onto the shaft 310 of the second engaging instrument 270 to perform the anastomosis procedure.

The medical device 200 comprises a first engaging device 210 and a second engaging device 270 that can be connected by assembling the shafts together. The second engaging device 270 has a protrusion 311 that can protrude radially when connected to the first engaging device 210. The separation portion 40 is configured to a height that does not contact the protrusion 311 when the shaft 310 is inserted through the hole portion Pr. This configuration enables the second engaging device 270 and the first engaging device 210 to be connected.

The separation portion 40 is also configured to have a higher hardness than the main body portion 10. Therefore, the separation portion is less hard than the main body portion 10, which can prevent or inhibit the main body portion 10 from separating from the separation portion 40 against the user's intention.

(Modification 1 of the first embodiment)
FIG. 13 is a diagram showing a medical device 100a according to a first modification of the first embodiment. In the first embodiment, the shapes of the hole Pr and the hole Pt of the separation unit 40 are described as being approximately circular. However, as long as the main body unit 10 can be separated from the separation unit when an external force is applied, the specific shapes of the hole and the hole are not limited to circular. In addition to the above, the hole Pra formed by the fixing unit 30a and the hole Pta of the separation unit 40a may be configured as a polygon such as a rectangle, as shown in FIG. 13. Furthermore, the cross section of the hole Pr may be configured as an ellipse, a triangle, a square, a concave shape, a convex shape, or the like. Note that the medical device 100a is similar to the first embodiment except for the shapes of the fixing unit 30a, the hole Pra, and the hole Pta of the separation unit 40a, and therefore a description of the common features will be omitted.

(Modification 2 of the First Embodiment)
14 is a plan view showing a medical device 100b according to Modification 2 of the first embodiment. In the first embodiment, the fixing portion 30 corresponding to the inner peripheral edge portion forming the hole portion Pr is described as being formed in a substantially circular shape in a plan view. However, the specific shape of the hole portion Pr is not limited to a circular shape as long as the main body portion 10 can be separated from the separation portion 40 when an external force is applied.

The fixing portion 30b of the main body portion 10 may be configured to have slits on the inner periphery, as shown in Figure 14. It is preferable that the slits be provided regularly in the circumferential direction θ so that the main body portion 10 can be separated from the separation portion 40 at the same time in the circumferential direction θ. Note that the separation portion 40 is not shown in Figure 14 to show the shape of the fixing portion 30b.

This configuration makes it easier to separate the main body 10 from the separation part 40. Note that this modification is the same as the first embodiment except for the shape of the fixing part 30b, which is the inner periphery of the main body 10, and the hole Prb, so a description of the common parts will be omitted.

Second Embodiment
Fig. 15 is a diagram showing a medical device 100c according to the second embodiment, and Fig. 16 is an exploded view of the medical device 100c according to the second embodiment. In the first embodiment, the separation portion 40 was described as including a first member 41, a second member 42, and a connecting portion 43. However, the separation portion can be configured as follows. Note that the main body portion 10, the reinforcing portion 20, the fixing portion 30, and the hole portion Pr are the same as those in the first embodiment, and therefore a description of the common parts will be omitted.

As shown in Figure 16, the separation unit 40c includes a third member 41c, a fourth member 42c, and a fifth member 43c. The ordinal numbers of the third member 41c, the fourth member 42c, and the fifth member 43c have been assigned consecutively since the first embodiment, but as mentioned at the beginning, the numbers are not limited to the above.

The third member 41c, fourth member 42c, and fifth member 43c are configured to include bases bd1, bd2, and bd3, each having a hole Pt through which the shaft 310 can be inserted, as shown in FIG. 16. The bases bd1, bd2, and bd3 are illustratively formed in an annular shape. The bases bd1, bd2, and bd3 are configured so that their outer shapes in plan view are equal to or smaller than the punching dimensions of the punching portion 250, so that the separation portion 40c can be removed from the body by a punching operation.

The base bd1 of the third member 41c is configured to have mounting portions 44c and holes 45c that hook onto and at least temporarily hold the main body 10. In this embodiment, the mounting portions 44c are arranged at regular intervals in the circumferential direction θ of the base bd1, and in this embodiment, three mounting portions are arranged at equal angular intervals in the circumferential direction θ. However, as long as the main body 10 can be held until it is separated by the punched portion 250, the number of mounting portions needs to be two or more, and the angular intervals do not need to be equal. The hole 45c is configured to be large enough to allow the protrusion 47c of the fourth member 42c on the base bd1 to pass through.

A connecting member 46c and a protrusion 47c are provided on the base bd2 of the fourth member 42c. The connecting member 46c connects the third member 41c and the fourth member 42c to the extent that the distance in the axial direction X can be adjusted within a predetermined range. By configuring the fourth member 42c as described above, it is possible for it to move towards or away from the third member 41c in the axial direction X of the main body 10. In this embodiment, the connecting member 46c is configured to join a spring to the base bd1 and the base bd2. However, as long as it can connect the third member and the fourth member within a predetermined range, an elastic member other than a spring may be joined to the base bd1 and the base bd2.

The protrusions 47c are configured to be able to apply an external force to the main body 10 so as to trigger separation of the main body 10 from the mounting portion 44c of the third member 41c. The protrusions 47c are configured to be able to pass through the holes 45c in the base bd1, thereby being able to apply an external force to the main body 10. In this embodiment, three protrusions 47c are provided on the base bd2, as shown in Figure 16. However, as long as the mounting force of the main body 10 on the mounting portion 44c can be reduced by compression in the axial direction X, the number of protrusions 47c is not limited to three and may be two or more.

The fifth member 43c is positioned on the opposite side of the fourth member 42c with respect to the third member 41c in the axial direction X of the main body portion 10. A suppression portion 48c is provided on the base bd3 of the fifth member 43c, positioned radially inward from the attachment portion 44c and the protrusion 47c and extending in the axial direction X. The fifth member 43c is configured so that the suppression portion 48c forms a gap Sc between the base bd3 and the main body portion 10, outward from the suppression portion 48c in the radial direction r (see FIG. 15). By providing the gap Sc, it is possible to prevent or suppress the main body portion 10 from being compressed in the axial direction X by the anal side A2 of the large intestine, preventing the main body portion 10 from being separated from the separation portion 40, when the protrusion 47c of the fourth member 42c separates the main body portion 10 from the attachment portion 44c.

The suppressing portion 48c suppresses movement of the third member 41c when an external force is applied by the protrusion 47c to the main body portion 10 held by the attachment portion 44c. The suppressing portion 48c is provided to protrude from the base bd3 toward the third member 41c and is integrally connected to the base bd1 of the third member 41c. In this embodiment, the suppressing portion 48c is configured to have a cylindrical shape with a hole Pt formed therein so that the shaft 310 of the second engagement device 270 of the medical device 200 can be inserted therethrough. The suppressing portion 48c prevents or suppresses compression of the main body portion 10 in the axial direction X when the main body portion 10 is sandwiched between biological organs. Furthermore, like the connecting portion 43 of the first embodiment, the suppressing portion 48c can be configured to provide a gap with the hole Pr of the main body portion 10 in the radial direction r.

Figures 17 to 20 are diagrams used to explain a treatment method using the medical device 100c of the second embodiment. The treatment method using the medical device 100c of this embodiment differs from that of the first embodiment in the principle by which the separation unit 40c separates the main body unit 10 from the separation unit 40c.

As shown in Figures 17 and 18, the surgeon inserts the shaft 310 of the second engagement instrument 270 of the medical instrument 200 into the oral side A1 of the large intestine outside the body, attaches the medical device 100 to the shaft 310, and then inserts the oral side A1 of the large intestine into the body, just as in the first embodiment. Then, just like in the first embodiment, the surgeon engages the positioning portion 230 of the first engagement instrument 210 with the shaft 310 of the second engagement instrument 270, brings them close together, and punches out the main body portion 10 with the punching portion 250.

Here, even if the main body portion 10 cannot be punched out, the protrusion 47c of the fourth member 42c of the separation portion 40c passes through the hole 45c and presses against the main body portion 10 at the attachment portion 44c, reducing the attachment force of the main body portion 10 at the separation portion 40c. This causes the punching portion 250 to apply a pulling force to the main body portion 10, separating the main body portion 10 from the separation portion 40c and leaving it in the body as shown in Figures 19 and 20, while allowing the separation portion 40c and the medical device 200 to be removed from the body during the punching operation. As the rest is the same as in the first embodiment, further explanation will be omitted.

As described above, in this embodiment, the separation portion 40c of the medical device 100c includes a third member 41c and a fourth member 42c. The third member 41c holds the main body portion 10 at least temporarily with an attachment portion 44c and has a hole portion 45c. The fourth member 42c includes a protrusion portion 47c that can be inserted through the hole portion 45c and applies an external force to the main body portion 10. The fourth member 42c is configured to be able to move toward and away from the third member 41c in the axial direction X of the main body portion 10.

This configuration allows the attachment portion 44c of the third member 41c to hold the main body portion 10 together until the protrusion 47c presses the main body portion 10. Furthermore, if the punching portion 250 cannot properly punch out the main body portion 10, the protrusion 47c can be used to separate the main body portion 10 from the third member 41c of the separation portion 40c, and the medical device 200 and the separation portion 40c can be removed from the body while the main body portion 10 remains at the anastomosis site. The inside of the main body portion 10 does not have to be circular; radial cuts can be made to make it easier to separate the main body portion 10 from the separation portion 40c, or the main body portion 10 can be shaped so that it is only present at the attachment portion 44c on the inside of the main body portion 10.

The separation unit 40c also includes a fifth member 43c. The fifth member 43c includes a suppression unit 48c that suppresses movement of the third member 41c when the protrusion 47c applies an external force to the main body unit 10 held by the third member 41c, and is arranged on the opposite side of the third member 41c from the fourth member 42c in the axial direction X of the main body unit 10. This configuration prevents or suppresses compression of the main body unit 10 when the main body unit 10 is clamped by the first engagement device 210 and the second engagement device 270 inside a biological organ, making it easier to separate the main body unit 10 from the separation unit 40c.

(Third embodiment)
21 to 24 are diagrams illustrating a medical device 100e according to a third embodiment. In the first embodiment, it was explained that the distance between the first member 41 and the second member 42 of the separation unit 40 is set to a degree that prevents the main body unit 10 from falling off before punching by the punching unit 250. In the second embodiment, it was explained that the protrusion 47c of the fourth member 42c presses the main body unit 10 through the hole 45c, thereby separating the main body unit 10 from the separation unit 40c. However, the separation unit can be configured as follows. Note that the main body unit 10 and the reinforcing unit 20 are the same as those in the first embodiment, and therefore their description will be omitted.

Similar to Variation 2 of the first embodiment, the fixing portion 30e is configured such that the inner peripheral edge of the main body portion 10 has a substantially circular shape with slits in the circumferential direction θ. In Figure 21, the fixing portion 30e has four slits in the circumferential direction θ, but this is merely an example, and the specific form of the slits in the fixing portion 30e is not limited to Figure 21 as long as it makes it easy to separate the main body portion 10 from the separation portion 40. The hole portion Pre is formed by a fixing portion 30e with slits, merely as an example. In other words, the fixing portion 30e may be formed without slits, such as a substantially circular shape, and the hole portion may also be formed by a fixing portion without slits.

As shown in FIG. 22, the separation section 40e comprises a body section Cye on which a flange section 41e (corresponding to the first section) is formed, a clamping member 42e, an expandable member 43e (corresponding to the elastic member), a moving member 44e (corresponding to the moving section), and a connecting member 45e (corresponding to the traction section). The separation section 40e is configured to be smaller than the inner diameter of the punching section 250 (the size of the punched section) when viewed in plan from the axial direction X, so that it can be removed from the body by the punching section 250.

As shown in FIG. 24, the body portion Cye forms an internal space Sp in which at least a portion of the movable member 44e can move back and forth, and is configured to have a hollow cylindrical shape 47e. Similar to the connecting portion 43 of the first embodiment, the cylindrical shape 47e can be formed to provide a gap with the fixed portion 30 in the radial direction r so that the main body portion 10 can be easily separated if punching by the punching portion 250 is not successful. The flange portion 41e is provided at one end of the cylindrical shape 47e of the body portion Cye in the axial direction X, and the flange portion 46e is provided at the other end of the cylindrical shape 47e. The flange portion 41e is configured as one of the parts that clamp the main body portion 10.

The clamping member 42e is integrally connected to the elastic member 43e and forms the other side (second portion) that clamps the main body 10. The clamping member 42e is configured so that its position in the axial direction X relative to the flange portion 41e can be changed by the elastic member 43e, which is elastically deformable in the axial direction X of the main body 10. The clamping member 42e is configured to be able to clamp the main body 10 together with the flange portion 41e when it is in the closest position to the flange portion 41e, as shown in Figures 21 and 22.

Furthermore, as shown in Figure 23, the clamping member 42e can release its clamping of the main body 10 by moving away from the flange portion 41e in the axial direction X. In this embodiment, the clamping member 42e is configured to include a hollow plate-shaped member, but the specific shape is not limited to a hollow plate-shaped member as long as it can clamp the main body 10 together with the flange portion 41e.

The elastic member 43e is configured to be elastic so as to bias the clamping member 42e toward the flange portion 41e. The elastic member 43e is arranged between the flange portions 41e and 46e so that it can expand and contract in the axial direction X due to elastic force or the like. This allows the clamping member 42e to clamp the main body portion 10 together with the flange portion 41e unless the connecting member 45e separates the clamping member 42e from the flange portion 41e. In this embodiment, the elastic member 43e is configured to include a spiral helical spring or the like. However, the specific configuration of the biasing member is not limited to a helical spring as long as it can bias the clamping member 42e toward the flange portion 41e.

The moving member 44e is configured to be able to move toward and away from the flange portion 41e in the axial direction X of the main body portion 10. The moving member 44e is configured to be able to move in the axial direction X relative to the body portion Cye on which the flange portion 41e is provided. As shown in Figure 24, the moving member 44e has an insertion portion 48e and an abutment portion 49e.

The insertion portion 48e is configured to be insertable into at least a portion of the internal space Sp of the body portion Cye. The insertion portion 48e has a hole Pt formed therein through which the shaft 310 can be inserted. The abutment portion 49e is formed continuous with the insertion portion 48e and is a portion that can abut against the body portion Cye and is configured to determine the terminal position in the movement direction of the moving member 44e. In this embodiment, the insertion portion 48e is configured as a hollow cylinder, and the abutment portion 49e is configured as a portion that protrudes outward in the radial direction r from the end of the insertion portion 48e in the axial direction X.

The connecting member 45e connects the clamping member 42e and the moving member 44e. The connecting member 45e is configured to be able to displace the position of the clamping member 42e relative to the flange portion 41e by pulling, so that the flange portion 41e and the clamping member 42e can switch between clamping and not clamping the main body portion 10 depending on the position of the moving member 44e. The connecting member 45e is configured to integrally connect the clamping member 42e, the body portion Cye, and the moving member 44e.

As a result, the connecting member 45e clamps the main body 10 between the flange 41e and the clamping member 42e when the moving member 44e is separated from the flange 41e as shown in Figures 21 and 22. Furthermore, when the moving member 44e is close to the flange 41e as shown in Figure 23, the connecting member 45e adjusts the position of the clamping member 42e so that the clamping of the main body 10 by the flange 41e and the clamping member 42e is released.

In this embodiment, the connecting member 45e can be configured to include a long, linear member such as a thread. The specific form of the connecting member 45e is not particularly limited, as long as it can pull the clamping member 42e with a uniform force in the circumferential direction θ. For example, the connecting member 45e can be configured as a thread-like member arranged at approximately three locations in the circumferential direction θ, at equal angular intervals. Furthermore, as shown in Figure 21, the connecting member 45e can be arranged further outward in the radial direction r than the expandable member 43e, so that the movable member 44e can move smoothly in the axial direction X.

The treatment method using the medical device 100e according to this embodiment is the same as that according to the first embodiment up to the point where the suture portion A11 is formed outside the body. Next, the surgeon attaches the medical device 100e to the second engaging instrument 270 so that the shaft 310 of the second engaging instrument 270 passes through the hole portion Pt. The surgeon then inserts the medical device 100e together with the second engaging instrument 270 into the body.

Subsequent operations are the same as in the first embodiment, except that the flange portion 41e and clamping member 42e clamp the main body portion 10 using the expandable member 43e until the first engaging device 210 and the second engaging device 270 are brought closer together. Then, when the first engaging device 210 and the second engaging device 270 are brought closer together by the surgeon's operation, the abutment portion 49e of the moving member 44e abuts against the body portion Cye, as shown in Figure 23.

As a result, the connecting member 45e pulls the clamping member 42e, compressing the expandable member 43e, reducing the contact area between the flange portion 41e and the clamping member 42e and the main body portion 10, and reducing the clamping force of the flange portion 41e and the clamping member 42e on the main body portion 10. When a punching operation is performed in this state, the main body portion 10 is punched out as described above, or even if it is not punched out, the clamping force between the flange portion 41e and the clamping member 42e is released or the clamping force is reduced. Therefore, the separation unit 40 and the medical device 200 can be removed from the body while the main body portion 10 remains in the anastomosis site. The subsequent operations are the same as in the first embodiment, so a description thereof will be omitted.

As described above, in this embodiment, the flange portion 41e constitutes one part of the clamping portion. The clamping member 42e clamps the main body portion 10 together with the flange portion 41e in the clamping portion, and its position relative to the flange portion 41e is changeable by the expandable member 43e. The movable member 44e is configured to be able to move toward and away from the flange portion 41e in the axial direction X of the main body portion 10. The connecting member 45e connects the end of the expandable member 43e to the movable member 44e, and is configured so that the end of the expandable member 43e can be displaced by pulling so that the flange portion 41e and the clamping member 42e can switch between clamping and not clamping the main body portion 10 depending on the position of the movable member 44e.

This allows the main body portion 10 to be clamped until the punching operation is performed, and even if the main body portion 10 cannot be punched out by the punching section 250 during the punching operation, the separation section 40e and medical device 200 can be removed from the body while leaving the main body portion 10 in place at the anastomosis site.

The separation unit 40e is configured to include a body portion Cye that forms an internal space Sp within which at least a portion of the insertion portion 48e can move back and forth, and a plate-shaped clamping member 42e that is integrally connected to the elastic member 43e and provided at its end. This allows the main body portion 10 to be clamped until the punching operation is performed, and even if the main body portion 10 cannot be punched out by the punching unit 250 during the punching operation, the separation unit 40e and medical device 200 can be removed from the body while leaving the main body portion 10 in place at the anastomosis site.

(Modification 1 of the third embodiment)
25 and 26 are views showing a separation portion 40f of a medical device 100f according to Modification 1 of the third embodiment. A body portion Cyf, which is a modification of the body portion Cye of the third embodiment, may be configured so that a slit St is provided in the circumferential direction θ in the cylindrical shape 47f and the flange portion 41f, as shown in FIGS. 25 and 26. Providing a slit St in the cylindrical shape 47f and the flange portion 41f makes it easier to assemble these components with other components. The configuration of the medical device 100f other than the body portion Cyf is the same as that of the first embodiment, and therefore a description thereof will be omitted.

(Modification 2 of the third embodiment)
27 and 28 are views showing a separation unit 40g of a medical device 100g according to Modification 2 of the third embodiment. In the third embodiment, the main body 10 is clamped by a flange 41e of the trunk Cye and a clamping member 42e. However, as long as the main body can be clamped and released by an expandable member 43e, a movable member 44e, and a connecting member 45e, the medical device does not need to be provided with a clamping member 42e as shown in FIGS. 27 and 28.

In this case, the main body 10 can be clamped by the end of the expandable member 43e and the flange 41e instead of the clamping member 42e, and the clamping between the flange 41e and the end of the expandable member 43e can be released by pulling the connecting member 45e. Note that the configuration of this modified example is the same as that of Modified Example 1 of the third embodiment, except for the fact that the clamping member 42e is not used, so detailed description will be omitted.

(Fourth embodiment)
Fig. 29 is a diagram showing a state in which the main body portion 10 is clamped by the separation portion 40h of the medical device 100h according to the fourth embodiment, and Fig. 30 is a diagram showing a state in which the clamping of the main body portion 10 by the separation portion 40h is released. In the third embodiment, it was explained that the elastic member 43e biases one of the clamping members toward the other to clamp the main body portion 10 between the flange portion 41e and the clamping member 42e, but it can also be configured as follows. Note that the main body portion 10, the reinforcing portion 20, and the hole portion Pr are the same as those in the first embodiment, and therefore their description will be omitted.

As shown in Figure 29, the separation section 40h comprises a pressing member 41h and a plate-shaped member 42h. The pressing member 41h contains an elastically deformable material and is configured to have a reversible curved portion 43h and an abutment portion 44h. The curved portion 43h is configured to be elastically deformable. The curved portion 43h is configured to be able to move toward the main body section 10 when placed adjacent to the main body section 10 in the axial direction X of the main body section 10.

In this embodiment, the abutment portion 44h is provided on the outer periphery of the curved portion 43h. The abutment portion 44h is shaped to face the main body portion 10, allowing it to abut against the main body portion 10 when placed adjacent to the main body portion 10. In addition, the curved portion 43h can be deformed so that it can be inverted to the side opposite the main body portion 10 so that its outer periphery does not come into contact with the main body portion 10.

With the curved portion 43h facing toward the main body 10, the abutting portion 44h, together with the plate-shaped member 42h, contacts the main body 10 and clamps the main body 10 together with the plate-shaped member 42h. Meanwhile, from a state in which the abutting portion 44h of the pressing member 41h clamps the main body 10 together with the plate-shaped member 42h, the curved portion 43h deforms to face away from the main body 10. This allows the pressing member 41h and the plate-shaped member 42h to release the clamping of the main body 10.

The plate-shaped member 42h is configured to be able to clamp the main body 10 together with the abutment portion 44h of the holding member 41h. In this embodiment, the plate-shaped member 42h is configured to include a flat plate-shaped member. However, as long as it can temporarily clamp the main body 10 together with the holding member 41h, the shape of the plate-shaped member 42h is not limited to a flat plate, and it may also be configured to have a curved portion similar to the holding member 41h. The holding member 41h and the plate-shaped member 42h are provided with a hole Pt through which the shaft 310 can be inserted. The holding member 41h and the plate-shaped member 42h are configured so that their outer dimensions are equal to or smaller than the punching diameter (size of the punched portion) of the punching portion 250 so that they can be removed from the biological organ by the punching portion 250.

The fixing portion 30 is configured with dimensions such that, if the main body portion 10 cannot be punched out by the punching portion 250, the deformable pressing member 41h in the separation portion 40h can pass through the hole portion Pr and remove the separation portion 40h from the body, as in the first embodiment.

The treatment method using the medical device 100h is the same as in the first embodiment up to the point where the suture A11 is formed outside the body. Next, the surgeon inserts the shaft 310 of the second engagement instrument 270 through the hole Pt of the plate-like member 42h, and then inserts the shaft 310 through the hole Pr of the main body 10. Next, the surgeon inserts the shaft 310 through the hole Pt of the pressing member 41h with the curved portion 43h facing the main body 10, and then abuts the abutment portion 44h against the main body 10 with at least a portion of the plate-like member 42h abutting against the main body 10.

As a result, the outer periphery of the abutment portion 44h, together with the plate-shaped member 42h, clamps the main body portion 10 and is integrally formed with the main body portion 10. The subsequent operation by the surgeon is the same as in the first embodiment.

When a portion of the biological organ is clamped between the first engaging device 210 and the second engaging device 270 and the first engaging device 210 and the second engaging device 270 are brought closer together, the curved portion 43h of the retaining member 41h is inverted and deformed so that it faces away from the main body portion 10, as shown in Figure 31. This causes the abutting portion 44h to no longer abut the main body portion 10, and the clamping of the main body portion 10 by the retaining member 41h and the plate-like member 42h is released. As a result, even if the punching portion 250 is unable to punch through the main body portion 10, the separating portion 40h and the medical device 200 can be removed from the body while leaving the main body portion 10 in place at the anastomosis.

As described above, the separation unit 40h in this embodiment comprises a pressing member 41h and a plate-like member 42h. The pressing member 41h is elastically deformable and, when placed adjacent to the main body unit 10 in the axial direction X of the main body unit 10, faces the main body unit 10 so that its outer periphery can abut against the main body unit 10, while also comprising a curved portion 43h that can be inverted to the opposite side from the main body unit 10. The plate-like member 42h is configured to be able to clamp the main body unit 10 together with the pressing member 41h.

When the curved portion 43h faces the main body 10 and the main body 10 is in contact with the outer periphery of the pressing member 41h and the plate-shaped member 42h, the abutment portion 44h, which is the outer periphery of the pressing member 41h, clamps the main body 10 together with the plate-shaped member 42h. As a result, the separation portion 40h is formed integrally with the main body 10. When the main body 10 is clamped between the pressing member 41h and the plate-shaped member 42h, the curved portion 43h faces away from the main body 10, and the clamping of the main body 10 by the pressing member 41h and the plate-shaped member 42h is released.

As a result, while the main body 10 is being clamped between the pressing member 41h and the plate-like member 42h, the pressing member 41h and the plate-like member 42h can be configured as an integral part of the main body 10. When the clamping of the main body 10 between the pressing member 41h and the plate-like member 42h is released, the detachable portion 40h can be separated from the main body 10, and the detachable portion 40h and the medical device 200 can be removed from the body while the main body 10 remains in place at the anastomosis site.

The present invention is not limited to the above-described embodiment, and various modifications are possible within the scope of the claims. In the first embodiment, the connecting portion 43 of the separation portion 40 was described as being formed in a cylindrical shape. However, as long as the separation portion 40 can be configured integrally with the main body portion 10 until the main body portion 10 is punched out by the medical device 200, a slit St similar to that shown in Figure 25 may also be provided in the connecting portion 43.

In addition, in the second embodiment, the third member 41c and fifth member 43c that make up the separation portion 40c are described as separate parts. However, if the main body portion 10 can be held in the attachment portion 44c until punching is performed, and the main body portion 10 can be separated from the separation portion 40c by the operation of the protrusion portion 47c, the third member 41c and fifth member 43c may be integrally configured as a single part.

10 main body,
11 through hole,
30 fixed part,
30b, 30e: fixing portion (inner peripheral edge portion with a slit);
40, 40a, 40c, 40e, 40f, 40g, 40h separation section,
41 first member,
41c third member,
41e flange portion (first portion),
41h pressing member,
42 second member,
42c fourth member;
42e clamping member (second part, plate-shaped member),
42h plate-shaped member,
43 Connecting part,
43c fifth member;
43e Elastic member (an elastic member (which may have a second portion at its end)),
43h curved part,
44e moving member (moving part),
44h contact part,
45e connecting member (towing part),
47c protrusion,
48c suppressor,
200 medical instruments,
210 first engagement device,
270 second engagement device,
310 shaft,
311 protrusion,
Cye, Cyf body part,
Pr hole part,
Pt, Pta hole.

Claims (12)

a sheet-like main body portion that can be placed at an anastomosis of a living organ and at least a portion of which contains a bioabsorbable material;
a separation portion that is integrally formed with the main body portion at a central portion of the main body portion and that can be separated from the main body portion by application of an external force ;
the main body portion has an inner periphery that forms a hole through which a shaft of a medical instrument can be inserted when the main body portion is applied to the anastomosis of the living organ;
A medical device , wherein the inner periphery has a slit formed therein to facilitate separation of the main body from the separation portion . The separation portion includes a first member disposed on one side of the main body portion in the thickness direction of the main body portion, and a second member disposed on the opposite side of the main body portion to the first member and sandwiching the main body portion together with the first member.
The medical device according to claim 1 , further comprising a connecting portion that connects the first member and the second member so as to space the first member and the second member apart in the thickness direction of the main body portion. The medical device according to claim 2 , wherein the first member and the second member have outer peripheries each having a size equal to or larger than the hole. a sheet-like main body portion that can be placed at an anastomosis of a living organ and at least a portion of which contains a bioabsorbable material;
a separation portion that is integrally formed with the main body portion at a central portion of the main body portion and that can be separated from the main body portion by application of an external force;
The separation unit is
a third member configured to at least temporarily hold the body portion and having a hole therein;
A medical device comprising : a fourth member that is capable of being inserted through the hole and that has a protrusion that applies the external force to the main body portion, and that is capable of moving toward and away from the third member in the thickness direction of the main body portion. The medical device described in claim 4, wherein the separation portion includes a suppression portion that suppresses movement of the third member when the external force is applied to the main body portion in which the protrusion portion is held by the third member, and further comprises a fifth member that is arranged on the opposite side of the third member from the fourth member in the thickness direction of the main body portion. a sheet-like main body portion that can be placed at an anastomosis of a living organ and at least a portion of which contains a bioabsorbable material;
a separation portion that is integrally formed with the main body portion at a central portion of the main body portion and that can be separated from the main body portion by application of an external force;
The separation unit is
a first portion constituting one side of a clamping portion that clamps the main body portion;
a second portion that forms the other side of the clamping portion and whose position relative to the first portion is changeable by an elastic member that is elastically deformable in a thickness direction of the main body portion;
a moving portion that is movable toward and away from the first portion in a thickness direction of the main body portion;
a pulling unit that connects the second portion and the moving unit and is capable of pulling and displacing the second portion relative to the first portion so as to switch between clamping and non-clamping of the main body portion by the clamping unit depending on the position of the moving unit;
The traction unit is
adjusting the position of the second portion so that the clamping portion clamps the main body portion in a separated state in which the moving portion is separated from the first portion;
A medical device that adjusts the position of the second part so as to release the clamping of the main body part by the clamping part when the moving part is in an approaching state in which it is approaching the first part. The separation unit is
a hollow body portion that provides the first portion and defines an internal space within which at least a portion of the moving portion can move forward and backward;
The medical device according to claim 6 , further comprising a plate-shaped member provided on the second portion and integrally connected to the elastic member. a sheet-like main body portion that can be placed at an anastomosis of a living organ and at least a portion of which contains a bioabsorbable material;
a separation portion that is integrally formed with the main body portion at a central portion of the main body portion and that can be separated from the main body portion by application of an external force;
The separating portion includes a pressing member that is elastically deformable and has a curved portion that can be turned toward the main body portion when the separating portion is disposed adjacent to the main body portion in the thickness direction of the main body portion, and has an outer periphery that can abut against the main body portion while being inverted to the opposite side of the main body portion, and a plate-like member that can sandwich the main body portion together with the pressing member,
the main body portion is disposed adjacent to and between the pressing member and the plate-like member, and the curved portion faces the main body portion so that the main body portion is in contact with the outer periphery of the curved portion and the plate-like member, the outer periphery of the pressing member sandwiches the main body portion together with the plate-like member, and is configured integrally with the main body portion;
A medical device in which the clamping of the main body portion between the pressing member and the plate-like member can be released by the curved portion facing away from the main body portion. The medical device according to any one of claims 1 to 7, wherein the main body portion has a plurality of through holes , and when applied to the anastomosis of the biological organ, biological components of the biological organ penetrate the through holes of the main body portion and accumulate, thereby promoting healing of the anastomosis. The medical device of claim 1 , wherein the inner periphery is formed so that the hole is larger than the shaft. The medical device includes a first engaging device and a second engaging device that can be connected by assembling their shafts together,
the second engaging device includes a protrusion that can protrude radially when connected to the first engaging device,
The medical device according to claim 1 , wherein the separation portion is configured to have a height such that the separation portion does not come into contact with the protrusion portion when the shaft is inserted through the hole portion. The medical device according to claim 2 or 8 , wherein the separation portion has a higher hardness than the main body portion.