JP2020162781A - Medical device - Google Patents

Abstract

To provide a medical device which can reduce a risk of an anastomotic leak in a postoperative period of a surgical operation or the like.SOLUTION: A medical device 100 includes a fusion promoting sheet 110 having a fusion promoting part 110A for promoting fusion of a biological tissue. In the fusion promoting sheet, a plurality of slits 120 which can expand and contract at least a part of the fusion promoting sheet in a direction intersecting a surface direction are formed.SELECTED DRAWING: Figure 1A

Description

The present invention relates to medical devices.

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

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

Japanese Patent Application Laid-Open No. 2007-505708

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

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

The medical device according to the embodiment of the present invention has a fusion promoting sheet provided with a fusion promoting portion for promoting fusion of living tissues, and the fusion promoting sheet includes at least a part of the fusion promoting sheet in a plane direction. On the other hand, a plurality of slits that can be expanded and contracted in the intersecting direction are formed.

According to the medical device according to the present invention, the fusion of the biological tissue of the biological organ can be promoted by sandwiching the fusion promoting sheet between the bonded sites of the biological organ to be joined. In addition, by using a plurality of slits formed in the fusion promoting sheet, a part of the fusion promoting sheet is extended in a direction intersecting the surface direction of the fusion promoting sheet and arranged so as to be along the outer surface of the living organ. , The fusion promoting sheet can be stably held in the living organ. Therefore, the surgeon can prevent the fusion promoting sheet from being displaced from the living organ or being twisted and deformed. Therefore, the risk of suture failure of living organs can be effectively reduced.

It is a perspective view which shows one form of the medical device of this invention. It is a perspective view which shows the use example of the medical device of FIG. 1A. It is sectional drawing which shows the part of the cross section along the line 2A-2A of FIG. 1A enlarged. It is a top view of the medical device of FIG. 1A. It is a perspective view which shows the modification 1 of the medical device of this invention. It is a perspective view which shows the use example of the medical device of FIG. 4A. FIG. 4A is a plan view of the medical device of FIG. 4A. It is a top view which shows the modification 2 of the medical device of this invention. It is a flowchart which shows each procedure of the treatment method using a medical device. It is a flowchart which shows the procedure of embodiment (pancreatic parenchymal-jejunal anastomosis) of a treatment method. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. FIG. 6 is a schematic cross-sectional view for explaining pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis. It is a schematic perspective view for explaining a pancreatic parenchymal-jejunal anastomosis.

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

FIG. 1A is a perspective view showing one form of the medical device 100. FIG. 1B is a perspective view showing a usage example of the medical device 100 of FIG. 1A. FIG. 2 is an enlarged cross-sectional view showing a part of the cross section taken along the line 2A-2A of FIG. 1A. FIG. 3 is a plan view of the medical device 100 as viewed from the surface 113 side.

<Medical device 100>
As shown in FIG. 1A, the medical device 100 has a fusion promoting sheet 110 arranged between biological organs to be joined, and traction portions 132 and 142 provided on the fusion promoting sheet 110.

As shown in FIGS. 9 to 16, the medical device 100 can be applied to a procedure for joining predetermined biological organs (for example, gastrointestinal anastomosis). As will be described later, in the description of the present specification, pancreatic parenchymal-jejunal anastomosis will be described as an example of a procedure using the medical device 100.

<Union promotion sheet 110>
As shown in FIGS. 1A, 1B, and 2, the fusion promoting sheet 110 has a fusion promoting portion 110A that promotes fusion of biological tissue formed from a biodegradable sheet having a plurality of through holes 112. Further, the fusion promoting sheet 110 is formed with a plurality of slits 120 that allow at least a part of the fusion promoting sheet 110 to expand and contract in a direction intersecting the plane direction.

The fusion promoting sheet 110 has a frame portion 110B provided on the outer side of the fusion promoting sheet 110 in the surface direction with respect to the fusion promoting portion 110A. In the present embodiment, the frame portion 110B is not formed with the through hole 112.

<Union Promotion Department 110A>
As shown in FIGS. 1A and 3, the through holes 112 formed in the fusion promoting portion 110A are regularly and periodically provided in the plane direction of the fusion promoting sheet 110. However, each through hole 112 may be randomly provided at each portion in the surface direction of the fusion promoting sheet 110.

As shown in FIG. 2, each through hole 112 extends substantially vertically between the front surface 113 and the back surface 114 along the thickness direction (vertical direction of FIG. 2) of the fusion promoting sheet 110. In addition, each through hole 112 may be bent or curved in a zigzag shape between the front surface 113 and the back surface 114 in the cross section along the thickness direction of the fusion promoting sheet 110.

As shown in FIG. 3, each through hole 112 has a substantially circular planar shape (shape when the front surface 113 of the fusion promoting sheet 110 or the back surface 114 of the fusion promoting sheet 110 is viewed in a plan view). However, the planar shape of each through hole 112 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.). Further, the plane shape and the cross-sectional shape may be different for each through hole 112.

As shown in FIG. 3, the fusion promoting sheet 110 has a substantially square planar shape with chamfered corners. However, the planar shape of the fusion promoting sheet 110 is not particularly limited, and may be, for example, a circle, an ellipse, or a polygon (rectangle, triangle, or the like). Even when the fusion promoting sheet 110 is formed in a plane shape other than the substantially square plane shape in which the corners shown in FIG. 3 are chamfered, the fusion promoting sheet 110 may have, for example, a plurality of slits 120, 220 (FIG. 3. It is possible to provide a plurality of slits having substantially the same pattern as (see FIGS. 5 and 6).

The thickness of the fusion promoting sheet 110 (dimension T shown in FIG. 2) is not particularly limited, but is preferably 0.05 to 0.3 mm, more preferably 0.1 to 0.2 mm. When the thickness of the fusion promoting portion 110A is 0.05 mm or more (particularly when it is 0.1 mm or more), the fusion promoting portion 110A can be provided with such strength that the fusion promoting portion 110A is not damaged when the fusion promoting sheet 110 is handled. On the other hand, when the thickness of the fusion promoting sheet 110 is 0.3 mm or less (particularly when it is 0.2 mm or less), the fusion promoting portion 110A adheres to the living tissue to which the fusion promoting sheet 110 is applied and follows the living tissue. It can be flexible enough to do so.

The fusion promoting sheet 110 is the ratio of the hole diameter D (distance D shown in FIG. 2) of the through hole 112 to the pitch P (distance P shown in FIG. 2 and the distance between adjacent through holes 112) of the through hole 112. The value is preferably 0.25 or more and less than 40. When the planar shape of the through hole 112 is a perfect circle, the hole diameter D of the through hole 112 is equal to the diameter of the perfect circle. On the other hand, when the planar shape of the through hole 112 is not a perfect circle, the diameter of a perfect circle having the same area as the area of the opening of the through hole 112 (the portion of the through hole 112 facing the front surface 113 or the back surface 114) ( The equivalent circle diameter) can be the hole diameter D of the through hole 112.

Since the fusion promoting portion 110A has a plurality of through holes 112, there are a plurality of values of the hole diameter D corresponding to each through hole 112. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the hole diameter D values corresponding to the plurality of through holes 112 is used as the representative value of the hole diameter D. .. On the other hand, the pitch P of the plurality of through holes 112 is defined by the shortest distance between the openings of the two through holes 112. However, as for the value of pitch P, there are a plurality of values of pitch P corresponding to the combination of adjacent through holes 112. Therefore, in the present embodiment, in calculating the above-mentioned ratio value, the arithmetic mean value of two or more points of the pitch P values corresponding to the combinations of the adjacent through holes 112 is used as the representative value of the pitch P. And.

The pitch P, the hole diameter D, the ratio of the hole diameter D to the pitch P, and the like of the through hole 112 are examples, and are not limited thereto.

The fusion promoting unit 110A can be made of a biodegradable material. The constituent material of the fusion promoting unit 110A is not particularly limited, and examples thereof include biodegradable resins. As the biodegradable resin, for example, those described in Japanese Patent Publication No. 2011-528275, Japanese Patent Publication No. 2008-514719, International Publication No. 2008-1952, Japanese Patent Publication No. 2004-509205 and the like are known. Biodegradable (co) polymers can be used. Specifically, it is selected from the group consisting of (1) aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose. Polymer; (2) A copolymer composed of one or more monomers constituting the above (1) and the like can be mentioned. That is, the biodegradable sheet is selected from the group consisting of aliphatic polyesters, polyesters, polyacid anhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and celluloses. It preferably contains at least one biodegradable resin selected from the group consisting of a polymer and a copolymer composed of one or more monomers constituting the polymer.

The method for producing the fusion promoting unit 110A is not particularly limited, and examples thereof include a method for producing a fiber made of the above-mentioned biodegradable resin and producing a mesh-shaped sheet using the fiber. The method for producing the fiber made of a biodegradable resin is not particularly limited, and examples thereof include an electrospinning method (electrospinning method / electrostatic spinning method) and a melt blow method. As the fusion promoting unit 110A, only one of the above methods may be selected and used, or two or more of the above methods may be selected and appropriately combined. As yet another example of the method for producing the fusion promoting unit 110A, the fibers made of the above-mentioned biodegradable resin are spun according to a conventional method, and the obtained fibers are knitted into a mesh shape to obtain biodegradability according to the present invention. Sheets may be manufactured.

The fusion promoting unit 110A induces a biological reaction by a constituent material such as a biodegradable resin constituting the fusion promoting unit 110A. The fusion promoting unit 110A induces the expression of biological components such as fibrin by this action. The biological components induced in this way can promote fusion by accumulating so as to penetrate through the through hole 112 of the fusion promoting portion 110A. Therefore, by arranging the fusion promoting portion 110A between the biological organs to be joined, the fusion is promoted by the above mechanism.

The material of the fusion promoting unit 110A does not have to be biodegradable as long as it can promote the fusion of biological organs. Further, the fusion promoting unit 110A may not have the through hole 112 formed regardless of the material, as long as it can promote the fusion of living organs.

As shown in FIGS. 1 and 3, the plurality of slits 120 are formed in the fusion promoting portion 110A. As shown in FIG. 2, each of the plurality of slits 120 penetrates the fusion promoting sheet 110 in the thickness direction, similarly to the through hole 112.

The plurality of slits 120 have a radial pattern extending within a predetermined range from the central portion C of the fusion promoting sheet 110 to the outer peripheral edge O side of the fusion promoting sheet 110.

The fusion promoting portion 110A has no slit formed on the virtual line H1 extending from the corner portion to the central portion C in the plan view of the fusion promoting sheet 110 with the first portion 115a in which the slit is formed sandwiched between them. The second part 115b is arranged so as to be adjacent to each other. Further, the fusion promoting portion 110A has a slit formed on the virtual line H2 extending from an arbitrary portion of the end edge located between the corner portions in the plan view of the fusion promoting sheet 110 to the central portion C. The first portion 115a in which the slit is formed is arranged so as to be adjacent to each other with the second portion 115b not provided in between. The length of the second portion 115b located on the virtual line H1 along the virtual line H1 is formed longer than the length of the second portion 115b located on the virtual line H2 along the virtual line H2. When the fusion promoting sheet 110 is formed in a plane shape other than the substantially square plane shape in which the corners shown in FIG. 3 are chamfered, the first portion 115a is formed according to the shape (pattern) of the plurality of slits 120 in the plan view. The positions of the second part 115b and the lengths of the first part 115a and the second part 115b along the virtual lines H1 and H2 can be changed as appropriate. For example, the plurality of slits 120 may be formed in an arc shape in a plan view of the fusion promoting sheet 110. Further, the plurality of slits 120 may be provided in at least one of the fusion promoting portion 110A and the frame portion 110B.

FIG. 1B shows a state in which the fusion promoting portion 110A of the fusion promoting sheet 110 is extended in the plane direction by the plurality of slits 120. The operator places the fusion promoting portion 110A of the fusion promoting sheet 110 on the cut surface B1a of the pancreatic parenchyma B1 to be joined, and pulls the fusion promoting sheet 110 in the extending direction of the pancreatic parenchyma B1 to the outside of the pancreatic parenchyma B1. The fusion promoting portion 110A can be extended along the surface. The surgeon can arrange the fusion promoting sheet 110 so as to be hooked on the pancreatic parenchyma B1 by extending the fusion promoting portion 110A. Further, since the fusion promoting portion 110A is deformed so as to follow the shape of the cut surface B1a of the pancreatic parenchyma B1, the fusion promoting portion 110A can be brought into close contact with the cut surface B1a of the pancreatic parenchyma B1.

<Frame part 110B>
As shown in FIGS. 1A and 3, the frame portion 110B is formed on the fusion promotion sheet 110 so as to surround the periphery of the fusion promotion portion 110A. The frame portion 110B is preferably formed to have a higher rigidity than the fusion promoting portion 110A so that the frame portion 110B is not easily deformed when an external force is applied. The frame portion 110B can be made of, for example, a biodegradable sheet in which a hole such as a through hole 112 is not formed, a resin sheet having a higher rigidity than the fusion promoting portion 110A, or a non-woven fabric.

Further, the fusion promoting sheet 110 may be provided with the frame portion 110B by not forming the through hole 112 in a certain region including the outer peripheral edge O of the biodegradable sheet which is a constituent material of the fusion promoting portion 110A. Further, after forming a through hole 112 in a certain region including the outer peripheral edge O of the biodegradable sheet which is a constituent material of the fusion promoting portion 110A, only the region is compressed or heated in the thickness direction to penetrate. By crushing the holes 112, a portion in which the constituent materials of the biodegradable sheet are densely assembled may be formed, and the portion may be used as the frame portion 110B.

A plurality of slits 120 are not formed in the frame portion 110B. Therefore, when the fusion promoting portion 110A is extended by the plurality of slits 120 as shown in FIG. 1B, the frame portion 110B is located at a position farther from the cut surface B1a of the pancreatic parenchyma B1 than the fusion promoting portion 110A. Arranged so as to make surface contact along the outer surface. Therefore, the holding power of the fusion promoting sheet 110 with respect to the pancreatic parenchyma B1 can be enhanced.

In addition, in the fusion promotion sheet 110, the entire fusion promotion sheet 110 may be composed of the fusion promotion unit 110A. That is, the fusion promotion sheet 110 may not be provided with the frame portion 110B.

<Towing parts 132, 142>
As shown in FIGS. 1A and 3, the medical device 100 is connected to the fusion promoting sheet 110, and has traction portions 132 and 142 that enable the fusion promotion sheet 110 to be expanded and contracted by the plurality of slits 120 in accordance with the traction operation. Have.

Each of the traction portions 132 and 142 can be composed of a string-shaped member or a strip-shaped member having a predetermined length. In the present embodiment, the traction portion 132 is connected to the fusion promotion sheet 110 by inserting the traction portion 132 into the insertion hole 131 formed in the frame portion 110B. Further, the traction portion 142 is connected to the fusion promotion sheet 110 by inserting the traction portion 142 into the insertion hole 141 formed in the frame portion 110B.

The traction portion 132 and the traction portion 142 are arranged at opposite positions of the fusion promoting sheet 110. As shown in FIG. 1B, the traction portion 132 corresponds to, for example, the anterior wall B1d of the pancreatic parenchyma B1 (the ventral portion in the circumferential direction of the pancreatic parenchyma B1) when the fusion promoting sheet 110 is placed on the pancreatic parenchyma B1. Can be placed in place. Further, the traction portion 142 can be arranged at a position corresponding to, for example, the posterior wall B1c of the pancreatic parenchyma B1 (the dorsal portion of the pancreatic parenchyma B1 in the circumferential direction).

Each traction portion 132, 142 is thermoplastic, for example, vinyl chloride, polyurethane elastomer, polystyrene elastomer, styrene-ethylene-butylene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), etc. It can be composed of an elastomer, a thermoplastic resin such as nylon or PET, or a metal such as rubber, silicone elastomer, fiber material, SUS wire, copper wire, titanium wire or nitinol wire. Further, each of the traction portions 132 and 142 may be made of, for example, the same material as the fusion promoting portion 110A. By using the same material as the fusion promoting unit 110A, it becomes possible to manufacture at the same manufacturing site as the fusion promoting unit 110A, so that the manufacturing operation becomes easy.

The installation of the traction portions 132 and 142 may be omitted, or only one of the traction portions 132 and 142 may be installed on the fusion promotion sheet 110. Further, the position where the traction portions 132 and 142 are arranged on the fusion promotion sheet 110 is not particularly limited. Further, the length, cross-sectional shape, thickness and the like of the towed portions 132 and 142 are not particularly limited.

As shown in FIG. 1B, when the fusion promoting portion 110A is extended, the operator pulls the traction portions 132 and 142 in a direction away from the cut surface B1a of the pancreatic parenchyma B1 along the extending direction of the pancreatic parenchyma B1. By doing so, the fusion promoting portion 110A can be extended by the plurality of slits 120 while the fusion promoting portion 110A is brought into close contact with the cut surface B1a. In the present embodiment, since the traction portions 132 and 142 are connected to the frame portion 110B, the fusion promotion sheet 110 is prevented from being torn when the traction portions 132 and 142 are towed. The traction force can be transmitted to 110.

As described above, the medical device 100 according to the present embodiment has a fusion promoting sheet 110 including a fusion promoting unit 110A that promotes fusion of living tissues, and the fusion promoting sheet 110 includes the fusion promoting sheet 110. A plurality of slits 120 are formed so that at least a part thereof can be expanded and contracted in a direction intersecting the plane direction.

According to the medical device 100 configured as described above, the fusion of the biological tissues of the biological organs can be promoted by sandwiching the fusion promoting sheet 110 between the bonded sites of the biological organs to be joined. .. Further, by the plurality of slits 120 formed in the fusion promoting sheet 110, a part of the fusion promoting sheet 110 is extended in a direction intersecting the surface direction and arranged so as to be along the outer surface of the living organ. The promotion sheet 110 can be stably held in a living organ. Therefore, the surgeon can prevent the fusion promoting sheet 110 from being displaced from the living organ or being twisted and deformed. Therefore, the risk of suture failure of living organs can be effectively reduced.

Further, the fusion promoting sheet 110 has a frame portion 110B provided on the outer side of the fusion promoting sheet 110 in the surface direction with respect to the fusion promoting portion 110A. Further, the plurality of slits 120 are formed in the fusion promoting portion 110A. Therefore, the operator can flexibly deform the fusion promoting portion 110A regardless of the difference in the shape and cross-sectional area of the jointed portion (for example, the cut surface B1a of the pancreatic parenchyma B1) that differs for each patient or case. Therefore, the fusion promoting portion 110A can be more reliably adhered to the bonded portion.

Further, the medical device 100 has traction portions 132 and 142 which are connected to the fusion promotion sheet 110 and enable expansion and contraction operation of the fusion promotion sheet 110 by a plurality of slits 120 in association with the traction operation. Therefore, the operator can easily extend the fusion promoting portion 110A by pulling the pulling portions 132 and 142.

Next, a modified example of the above-described embodiment will be described. In the description of the modified example, detailed description of the constituent members and the like already described in the above-described embodiment will be omitted. Further, the contents not particularly explained in the description of the modified example can be the same as those in the above-described embodiment.

<Modification example 1>
4A is a perspective view of the medical device 200 according to the modified example 1, FIG. 4B is a perspective view showing a usage example of the medical device 200 according to the modified example 1, and FIG. 5 is a plan view of the medical device 200 according to the modified example 1. It is a figure.

As shown in FIGS. 4A and 5, in the fusion promoting sheet 210 included in the medical device 200 according to the first modification, a plurality of slits are not formed in the fusion promoting portion 110A, and a plurality of slits 220 are formed in the frame portion 110B. Is formed.

The frame portion 110B has a slit formed on the virtual line H1 extending from the corner portion to the central portion C in the plan view of the fusion promoting sheet 210 with the second portion 115b in which the slit is not formed sandwiched between them. One site 115a is arranged so as to be adjacent to each other. Further, the frame portion 110B is not formed with a slit on the virtual line H2 extending from an arbitrary portion of the end edge located between the corner portions in the plan view of the fusion promoting sheet 210 to the central portion C. The first portion 115a in which the slit is formed is arranged so as to be adjacent to each other with the second portion 115b sandwiched between them. The length of the second portion 115b located on the virtual line H1 along the virtual line H1 is formed longer than the length of the second portion 115b located on the virtual line H2 along the virtual line H2.

FIG. 4B shows a state in which the frame portion 110B arranged so as to surround the fusion promoting portion 110A of the fusion promoting sheet 210 is extended in the plane direction by the plurality of slits 220. The operator places the fusion promoting portion 110A of the fusion promoting sheet 210 on the cut surface B1a of the pancreatic parenchyma B1 to be joined, and pulls the fusion promoting sheet 210 in the extending direction of the pancreatic parenchyma B1 to the outside of the pancreatic parenchyma B1. The frame portion 110B can be extended along the surface. The surgeon can arrange the frame portion 110B so as to be hooked on the outer peripheral surface of the pancreatic parenchyma B1. Therefore, the holding power of the fusion promoting sheet 210 with respect to the pancreatic parenchyma B1 can be further enhanced.

<Modification 2>
FIG. 6 is a plan view of the medical device 300 according to the second modification.

As shown in FIG. 6, in the fusion promoting sheet 310 included in the medical device 300 according to the second modification, a plurality of slits 220 are formed only in a part of the fusion promoting sheet 310 in the circumferential direction in a plan view. The plurality of slits 220 are formed only in the frame portion 110B as in the first modification.

The plurality of slits 220 can be formed, for example, only in a part in the circumferential direction corresponding to the anterior wall B1d of the pancreatic parenchyma B1 (the ventral portion in the circumferential direction of the pancreatic parenchyma B1). When the plurality of slits 220 are formed in this way, it corresponds to the posterior wall B1c of the pancreatic parenchyma B1 of the fusion promoting sheet 310 (the dorsal portion in the circumferential direction of the pancreatic parenchyma B1) in the procedure using the fusion promoting sheet 310. After the portion is sewn to the posterior wall B1c and fixed, the traction portion 132 is towed by the anterior wall B1d of the pancreatic parenchyma B1 (the ventral portion in the circumferential direction of the pancreatic parenchyma B1) to cause wrinkles on the fusion promoting sheet 310. It can be stretched firmly so that it does not occur. Therefore, the fusion promoting portion 110A of the fusion promoting sheet 310 can be more appropriately held on the cut surface B1a of the pancreatic parenchyma B1.

<Example of treatment method (living organ anastomosis)>
Next, a treatment method using a medical device will be described.

FIG. 7 is a flowchart showing each procedure of the treatment method using the medical device.

The treatment method is to prepare a medical device including a fusion promoting sheet in which a plurality of slits are formed (S11), to arrange the fusion promoting sheet at one of the joint sites (S12), and to extend the fusion promoting sheet. (S13), the fusion promoting sheet is fixed to one of the bonded sites (S14), and one of the fusion promoting sheets is arranged between one bonded site and the other bonded site. It includes joining the joined portion and the other joined portion (S15).

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. In the following description, pancreatic parenchymal-jejunal anastomosis will be described as an example. However, the above-mentioned treatment method may be applied to colon anastomosis or gastric tube anastomosis. Further, as the medical device used in each of the procedures described below, for example, any one can be selected from the above-mentioned medical devices. However, in the following description, a usage example of a specific medical device will be described as a typical example that can be suitably used for each procedure. Further, in each procedure described below, detailed description of known procedure procedures and known medical devices / instruments will be omitted as appropriate.

Hereinafter, in the description of the present specification, "arranging the fusion promoting sheet between the living organs" means that the fusion promoting sheet is arranged in a state of being in direct or indirect contact with the living organ, and the living organ and the living organ. The fusion-promoting sheet is placed with a spatial gap formed between the two, or the fusion-promoting sheet is placed in both states (for example, the fusion-promoting sheet comes into contact with one of the biological organs). , The fusion promoting sheet is placed in contact with the other living organ). Further, in the description of the present specification, the term "periphery" does not define a strict range (region), but a predetermined range (region) as long as the purpose of treatment (bonding between biological organs) can be achieved. Means. In addition, the order of the procedure procedures described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved.

<Example of treatment method (pancreatic parenchyma-jejunal anastomosis)>
FIG. 8 is a flowchart showing the procedure of the embodiment of the treatment method (pancreatic parenchymal-jejunal anastomosis), and FIGS. 9 to 16 are views provided for explaining the pancreatic parenchymal-jejunal anastomosis.

In the treatment method according to the present embodiment, the biological organs to be joined are the pancreatic parenchyma B1 after pancreaticoduodenectomy and the jejunum B2. In the following description, a procedure for joining the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 (one joined site) and an arbitrary site of the intestinal wall of the jejunum B2 (the other joined site) will be described. Further, in the present embodiment, an example of using the medical device 100 shown in FIG. 1A will be described.

As shown in FIG. 8, the treatment method according to the present embodiment is to prepare a medical device 100 including a fusion promoting sheet 110 in which a plurality of slits 120 are formed (S101), and the fusion promoting sheet 110 is used as a pancreatic parenchyma B1. Placing it on the cut surface B1a (S102), extending a part of the fusion promoting sheet 110 through a plurality of slits 120 (S103), fixing the fusion promoting sheet with a fixing member (S104), and pancreatic parenchyma B1. The fusion promoting sheet 110 is sandwiched between the jejunum B2 (S105), the fusion promoting sheet 110 is sandwiched between the pancreatic parenchyma B1 and the jejunum B2 (S106), and the fusion promoting sheet 110 is sandwiched between the pancreatic parenchyma B1 and the jejunum B2. Indwelling the fusion promoting sheet 110 (S107).

Next, an example of the treatment method according to the present embodiment will be specifically described with reference to FIGS. 9 to 16. In FIG. 14, a plurality of needles at both ends 920a to 920e, which will be described later, are omitted.

As shown in FIG. 9, the operator arranges the back surface 114 (or surface 113) of the fusion promoting sheet 110 so as to face the cut surface B1a of the pancreatic parenchyma B1. The surgeon pulls the traction portions 132 and 142 in a state where the fusion promoting portion 110A is arranged on the cut surface B1a of the pancreatic parenchyma B1 to pull the fusion promoting portion 110A of the fusion promoting sheet 110 into the cut surface B1a of the pancreatic parenchyma B1. Can be brought into close contact with (see FIG. 1B).

When arranging the fusion promoting sheet 110 on the cut surface B1a of the pancreatic parenchyma B1, the operator can adopt the following work procedure. First, the operator forms a hole 130 in the fusion promoting sheet 110 by pressing the end 911 (or end 912) of the pancreatic duct tube 910 against the fusion promoting sheet 110. In addition, the operator performed the pancreatic duct tube so that the end 911 of the pancreatic duct tube 910 passes through the inside of the jejunum B2 through the through hole B2a of the planned anastomosis site of the jejunum B2 and exits from the through hole B2b of the jejunum B2 to the outside of the jejunum B2. 910 is inserted into jejunum B2.

Next, the operator temporarily inserts the end portion 912 of the pancreatic duct tube 910 into the pancreatic duct B1b of the pancreatic parenchyma B1 while the pancreatic duct tube 910 inserts the hole 130 of the fusion promoting sheet 110 and holds the fusion promoting sheet 110. To do.

As the pancreatic duct tube 910, for example, a known resin tube having a bump (convex portion) formed on the end portion 912 to prevent removal can be used. The pancreatic duct tube 910 temporarily inserted into the pancreatic duct B1b suppresses the leakage of body fluid such as pancreatic juice from the pancreatic duct B1b during the procedure. According to such a procedure, the operator can arrange the fusion promoting sheet 110 and temporarily insert the pancreatic duct tube 910 at the same time.

In addition, the operator may use a device other than the pancreatic duct tube 910 when forming the hole 130 for inserting the pancreatic duct tube 910. Further, the hole 130 through which the pancreatic duct tube 910 is inserted may be formed in the fusion promoting sheet 110 in advance in a state before use. Further, the operator may temporarily insert the pancreatic duct tube 910 into the pancreatic duct B1b after arranging the fusion promoting sheet 110 on the cut surface B1a of the pancreatic parenchyma B1.

Next, the operator fixes the fusion promoting sheet 110 to the pancreatic parenchyma B1 with a fixing member. In the following description, an example of a procedure for fixing the fusion promoting sheet 110 to the pancreatic parenchyma B1 by using a plurality of both end needles 920a to 920e with sutures as fixing members will be described. As the needles at both ends 920a to 920e, known needles having a bioabsorbable absorbent thread (suture) and a biocompatible needle portion attached to both ends of the absorbent thread can be used. The needles 930 and 940a to 940e at both ends, which will be described later, are also configured to include an absorbent thread and a needle portion.

First, as shown in FIG. 10, the operator holds the fusion promoting sheet 110 against the pancreatic parenchyma B1 and holds the posterior wall B1c of the pancreatic parenchyma B1 (the dorsal portion of the pancreatic parenchyma B1 in the circumferential direction) and Both ends needles 920a are moved from the portion of the fusion promoting sheet 110 arranged on the posterior wall B1c toward the anterior wall B1d of the pancreatic parenchyma B1 and the portion of the fusion promoting sheet 110 arranged on the anterior wall B1d. Next, the operator moves both ends of the needle 920a so as to insert the jejunal serosal muscular layer at the planned anastomosis site of the jejunum B2 (around the through hole B2a). The operator repeats such an operation, and as shown in FIG. 11, a plurality of both ends needles 920a to 920e on the jejunal serosal muscular layer of the fusion promoting sheet 110, the pancreatic parenchyma B1, and the jejunum B2, and a plurality of both ends needles 920a to The 920e is inserted. In this way, the operator can fix the fusion promoting sheet 110 to the pancreatic parenchyma B1 by using a plurality of both end needles 920a to 920e that suture the pancreatic parenchyma B1 and the jejunum B2.

The operator may interrupt the traction operation by the traction portions 132 and 142 after fixing the fusion promotion sheet 110 to the cut surface B1a of the pancreatic parenchyma B1. The traction portions 132 and 142 may be appropriately separated from the fusion promoting sheet 110. Until the fusion promoting sheet 110 is fixed to the cut surface B1a of the pancreatic parenchyma B1, the surgeon extends the fusion promoting portion 110A of the fusion promoting sheet 110 through the plurality of slits 120 and adheres to the cut surface B1a of the pancreatic parenchyma B1. By maintaining the state, it is possible to prevent the fusion promoting sheet 110 from being displaced or dropped from the cut surface B1a of the pancreatic parenchyma B1.

The number of both-end needles to be inserted into the jejunal serosal muscular layer of the pancreatic parenchyma B1 and the jejunum B2 and the position to insert the both-end needles are not particularly limited. Further, the operator may fix the fusion promoting sheet 110 to the pancreatic parenchyma B1 using biodegradable staples or the like as a fixing member instead of the plurality of needles 920a to 920e at both ends.

The operator then removes the end 912 of the pancreatic duct tube 910 from the pancreatic duct B1b, as shown in FIG.

Next, as shown in FIG. 10, the operator passes the needles 930 at both ends from the lumen side of the pancreatic duct B1b toward the portion of the cut surface B1a of the pancreatic parenchyma B1 on the anterior wall B1d side. The needles 930 at both ends are held by a gripping instrument such as tweezers (not shown) so as not to interfere with the procedure in a state where the jejunum B2 is not inserted.

Next, as shown in FIGS. 11 and 13, the operator moves one end of the needles 940a at both ends from the lumen side of the pancreatic duct B1b toward the cut surface B1a of the pancreatic parenchyma B1. Next, as shown in FIGS. 12 and 13, the operator inserts the other end of the needles 940a at both ends into the through hole B2a of the air bowel B2, and the needles at both ends 940a from the inside of the air bowel B2 toward the outside of the air bowel B2 Move the other end. Then, as shown in FIG. 14, the operator inserts a plurality of both-end needles 940a to 940e into different sites in the circumferential direction of the pancreatic duct B1b and the jejunum B2. FIG. 13 is a cross-sectional view schematically showing a part of the pancreatic parenchyma B1 and the jejunum B2 before being anastomosed.

Next, as shown in FIG. 14, the operator brings the posterior wall B1c of the pancreatic parenchyma B1 and the pancreatic duct B1b into close contact with the planned anastomosis site of the jejunum B2. Then, of the plurality of needles 940a to 940e at both ends, the needles 940c to 940e at both ends that insert the dorsal side (rear wall B1c side) of the pancreatic duct B1b in the circumferential direction are ligated.

The operator then reinserts the end 912 of the pancreatic duct tube 910 into the pancreatic duct B1b, as shown in FIG. Next, the operator inserts the needle portion 931 extending from the inside of the pancreatic duct B1b in the needles 930 at both ends into the through hole B2b formed in the jejunum B2, and moves the needle portion 931 from the inside of the jejunum B2 toward the outside of the jejunum B2. To do.

Next, the operator ligates the needles 930, 940a, and 940b at both ends (not shown). The number of both-end needles to be inserted into the pancreatic duct B1b and the jejunum B2 and the position to insert the both-end needles are not particularly limited.

Next, as shown in FIG. 16, the operator ligates the needles 920a to 920e at both ends while pressing the jejunum B2 against the pancreatic parenchyma B1 with the operator's finger. As a result, the pancreatic parenchyma B1 and the jejunum B2 are sutured with the fusion promoting sheet 110 sandwiched between them. The jejunum B2 is deformed by the tension generated at the time of suturing so as to enclose the cut surface B1a of the pancreatic parenchyma B1 and the fusion promoting portion 110A of the fusion promoting sheet 110.

The operator places the fusion promoting sheet 110 in a state where the fusion promoting portion 110A of the fusion promoting sheet 110 is sandwiched between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. The fusion promoting portion 110A of the fusion promoting sheet 110 is placed between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2 while being in contact with the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. This promotes the fusion of the biological tissue of the pancreatic parenchyma B1 and the biological tissue of the intestinal wall of the jejunum B2.

As described above, the treatment method according to the present embodiment is applied to the procedure for joining the pancreatic parenchyma B1 and the jejunum B2. Further, in the above treatment method, the periphery of the cut surface B1a of the cut pancreatic parenchyma B1 and the intestinal wall (jejunum serosal muscular layer) of the jejunum B2 are joined. According to this treatment method, the biological tissue of the pancreatic parenchyma B1 and the living body of the intestinal wall of the jejunum B2 are formed by the fusion promoting portion 110A of the fusion promoting sheet 110 sandwiched between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. Tissue fusion can be promoted and the risk of suture failure after pancreatic parenchymal-jejunostomy can be reduced.

Further, by extending at least a part of the fusion promoting sheet 110 in a direction intersecting the surface direction of the fusion promoting sheet 110 by the plurality of slits 120 formed in the fusion promoting sheet 110, the fusion promoting unit 110A is in the middle of the procedure. Can be brought into close contact with the cut surface B1a of the pancreatic parenchyma B1.

100, 200, 300 medical devices,
110, 210, 320 fusion promotion sheet,
110A Healing Promotion Department,
110B frame,
112 through hole,
120, 220 multiple slits,
132, 142 Tow part,
B1 pancreatic parenchyma,
B2 jejunum.

Claims (4)

It has a fusion promotion sheet with a fusion promotion part that promotes the fusion of living tissues.
A medical device in which a plurality of slits are formed in the fusion promoting sheet so that at least a part of the fusion promoting sheet can be expanded and contracted in a direction intersecting the plane direction. The fusion promoting sheet has a frame portion provided on the outer side of the fusion promoting sheet in the surface direction of the fusion promoting portion.
The fusion promoting device according to claim 1, wherein the plurality of slits are formed in at least one of the fusion promoting portion and the frame portion. The fusion promoting device according to claim 1 or 2, wherein the plurality of slits are formed only in a part in the circumferential direction of the fusion promoting sheet in a plan view. The fusion promoting device according to any one of claims 1 to 3, which is connected to the fusion promoting sheet and has a traction portion capable of expanding and contracting the fusion promoting sheet by the plurality of slits in association with the traction operation.