JP2020162752A - 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 comprises: a fusion promoting sheet 110 including a body part 111 for promoting fusion of a biological tissue; and a holding member 120 including a pair of elastically deformable sandwiching parts 121 which sandwiches at least a part of the body part and at least a part of a biological organ for holding the body part relative to the biological organ, a gap part 122 which is formed between the pair of the sandwiching parts and can receive at least a part of the biological organ in a part between the pair of sandwiching parts, and a deformation guide part 123 for expanding and contracting the body part in a surface direction as a width of the gap part becomes wider or narrower due to the elastic deformation of the pair of sandwiching parts.SELECTED DRAWING: Figure 1

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.

A medical device according to an embodiment of the present invention sandwiches at least a part of the main body and at least a part of the living organ into the living organ by sandwiching a fusion promoting sheet having a main body for promoting the healing of living tissue. On the other hand, a gap formed between the pair of elastically deformable sandwiches for holding the main body and the pair of sandwiches so as to accept at least a part of the biological organ between the pair of sandwiches. A holding member including a portion and a deformation guiding portion that expands and contracts the main body portion in the surface direction as the gap portion is widened or narrowed due to elastic deformation of the pair of holding portions.

According to the medical device according to the present invention, it is possible to promote the fusion of the biological tissues of the biological organs by sandwiching the main body portion between the biological organs to be joined. In addition, the surgeon assists the holding of the main body with respect to the living organ to be joined by using the holding member while the procedure is being performed, so that the main body is displaced from the living organ or deformed. Can be prevented from doing so. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

It is a perspective view which shows one form of the medical device of this invention. It is sectional drawing which enlarges and shows a part of the cross section along line 2A-2A of FIG. It is a perspective view which shows the modification of the medical device. 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. 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.

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. 1 is a perspective view showing one form of the medical device 100. FIG. 2 is an enlarged cross-sectional view showing a part of a cross section taken along line 2-2 of FIG.

<Medical device 100>
As shown in FIG. 1, the medical device 100 includes a fusion promoting sheet 110 arranged between living organs to be joined, a holding member 120 assisting the holding of the fusion promoting sheet 110 to the living organ to be joined, and the like. To be equipped.

As shown in FIGS. 6 to 13, the medical device 100 can be applied to a procedure for joining predetermined biological organs (for example, anastomosis of the digestive tract). 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 FIG. 1, the fusion promoting sheet 110 is formed of a biodegradable sheet having a plurality of through holes 112, and has a main body portion 111 that promotes fusion of living tissues.

As shown in FIG. 1, the through holes 112 formed in the main body 111 are regularly and periodically provided in the plane direction of the main body 111. However, each through hole 112 may be randomly provided in each portion of the main body portion 111 in the surface direction.

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 of the main body 111 (vertical direction in FIG. 2). 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 main body portion 111.

Each through hole 112 has a substantially circular planar shape (shape when the front surface 113 of the main body 111 or the back surface 114 of the main body 111 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.

The main body 111 has a substantially circular planar shape. However, the planar shape of the main body 111 is not particularly limited, and may be, for example, an ellipse or a polygon (rectangle, triangle, etc.).

The thickness of the main body 111 (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 main body 111 is 0.05 mm or more (particularly 0.1 mm or more), the strength is such that the main body 111 is not damaged when the fusion promoting sheet 110 is handled. On the other hand, when the thickness of the main body 111 is 0.3 mm or less (particularly when it is 0.2 mm or less), the main body 111 adheres to the biological tissue to which the main body 111 is applied and follows the biological tissue. It can be provided with sufficient flexibility.

The main body 111 is the value of 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. However, it 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 main body 111 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 main body 111 can be made of a biodegradable material. The constituent material of the main body 111 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 manufacturing method of the main body 111 is not particularly limited, and examples thereof include a method of manufacturing a fiber made of the above-mentioned biodegradable resin and manufacturing 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 main body 111, 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 manufacturing the main body 111, the biodegradable sheet according to the present invention is obtained by spinning the fibers made of the biodegradable resin described above according to a conventional method and knitting the obtained fibers into a mesh shape. May be manufactured.

The main body 111 induces a biological reaction by a constituent material such as a biodegradable resin constituting the main body 111. The main body 111 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 main body 111. Therefore, by arranging the main body 111 of the fusion promoting sheet 110 between the biological organs to be joined, the fusion is promoted by the above mechanism.

The material of the main body 111 does not have to be biodegradable as long as it can promote fusion. Further, the main body 111 may not have a through hole 112 formed regardless of the material as long as it is possible to promote fusion.

<Holding member 120>
As shown in FIGS. 1, 6 and 7, the holding member 120 is a pair of holding portions that hold at least a part of the main body 111 and at least a part of the living organ to hold the main body 111 with respect to the living organ. It is provided with a gap 122 formed between the pair of holding portions 121 and allowing at least a part of a living organ to be received between the pair of holding portions 121.

As shown in FIG. 1, the pair of holding portions 121 have a substantially U-shaped outer shape. Further, the pair of holding portions 121 are arranged on the surface 113 side of the main body portion 111, and are arranged on the inner side of the peripheral edge 116 of the main body portion 111.

As shown in FIGS. 6 and 7, the pair of sandwiching portions 121 are arranged in the circumferential direction with respect to the cut surface of the biological organ in which the main body portion 111 is arranged. Then, the pair of sandwiching portions 121 sandwich the main body portion 111 of the fusion promoting sheet 110 arranged in the biological organ to be joined at least partially.

As shown in FIGS. 6 and 7, the size of the main body 111 is preferably large enough to cover the cut surface of the biological organ in which the main body 111 is arranged. Further, it is preferable that the size of the pair of sandwiching portions 121 is substantially the same as the cut surface of the biological organ on which the main body portion 111 is arranged. Therefore, the pair of holding portions 121 are preferably arranged on the inner side of the peripheral edge 116 of the main body portion 111.

There is no particular limitation on the size of the pair of sandwiching portions 121. However, as shown in FIGS. 6 and 7, the pair of sandwiching portions 121 is preferably sized so that more than half of the peripheral edge can be sandwiched in the cut surface of the biological organ in which the main body portion 111 is arranged.

The pair of sandwiching portions 121 can be made of, for example, a superelastic alloy such as an alloy of titanium and nickel. As long as it can be elastically deformed, it may be a metal material or a resin material, and is not particularly limited.

As shown in FIG. 1, the gap portion 122 has a width E1. The width E1 is a linear distance from the first end portion 124 to the second end portion 125 included in the pair of holding portions 121.

The value of the width E1 of the gap portion 122 is not particularly limited. However, as shown in FIG. 1, the width E1 of the gap portion 122 is preferably narrower than the maximum width E2 of the main body portion 111. The maximum width E2 of the main body 111 refers to the diameter of the main body 111 when the main body 111 is substantially circular. The diameter of the main body 111 is preferably larger than the maximum width (not shown) of the biological organ on which the main body 111 is arranged (see FIGS. 6 and 7). On the other hand, the width E1 of the gap portion 122 of the holding member 120 is preferably narrower than the maximum width of the biological organ in which the main body portion 111 is arranged.

By expanding the width E1 of the gap portion 122, the holding member 120 receives the biological organ between the gap portion 122 and the pair of sandwiching portions 121, and at least a part of the main body portion 111 and at least a part of the peripheral edge of the biological organ. Can be sandwiched. Further, since the pair of holding portions 121 can be elastically deformed, a holding force for a living organ can be applied to the main body portion 111. Therefore, the operator (operator such as a doctor) can prevent the fusion promoting sheet 110 from being displaced from the living organ and falling off by the holding member 120 while the procedure is being performed. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

The shape of the pair of holding portions 121 can have a gap portion 122 that allows at least a part of the main body portion 111 and at least a part of the living organ to be received between the pair of holding parts 121, and has a gap portion 122 with respect to the living organ. The shape is not particularly limited as long as the shape can impart the holding force to the main body 111. For example, it may be a notch shape in which a gap 122 is provided in a part of a polygon or a cloud shape (outer shape when a part of a circle is combined with each side of the polygon). As a result, the pair of sandwiching portions 121 can hold the main body portion 111 at least partially with respect to the biological organ regardless of the shape of the biological organ that sandwiches the main body portion 111. Therefore, the operator can adopt the shape of the pair of holding portions 121 according to the shape of the living organ.

Further, the arrangement of the pair of holding portions 121 with respect to the main body portion 111 is not limited to being located on the inner side of the peripheral edge 116 of the main body portion 111. As long as the main body 111 can be held at least partially with respect to the living organ, it can be changed without departing from the gist.

As shown in FIG. 1, the holding member 120 further includes a deformation guiding portion 123 that expands and contracts the main body portion 111 in the surface direction as the gap portion 122 expands or narrows due to elastic deformation of the pair of holding portions 121.

As shown in FIG. 1, two sets of deformation guiding portions 123 are provided at different positions of the pair of sandwiching portions 121. Each deformation guiding portion 123 is provided at a position facing each other in each holding portion 121. The opposing locations in the respective sandwiching portions 121 are locations facing each other with reference to the virtual symmetry lines L1 and L2 passing through the center position O of the main body portion 111 in which the pair of sandwiching portions 121 are arranged.

As shown in FIG. 1, each deformation guiding portion 123 is connected to the main body portion 111 by partially inserting it into the main body portion 111. As a result, the width of each deformation guiding portion 123 provided at the opposite positions on the virtual symmetry lines L1 and L2 is expanded in accordance with the operation of expanding or narrowing the width E1 of the gap portion 122. , It is narrowed. Therefore, the deformation guiding portion 123 can expand and contract the main body portion 111 connected to the deformation guiding portion 123 in the surface direction.

As shown in FIG. 1, the main body 111 is a sheet-like member, and is therefore easily deformed. Therefore, the main body 111 is likely to be twisted or misaligned. On the other hand, in the holding member 120, the main body 111 can be expanded and contracted in the surface direction by the deformation guiding portion 123, and the main body 111 can be brought into close contact with the cut surface of the living organ. Therefore, the operator can fix the main body 111 to the cut surface of the biological organ with a fixing member such as a biodegradable suture (absorbent thread) or a staple while the main body 111 is in close contact with the cut surface of the biological organ. .. As a result, the operator can prevent the fusion promoting sheet 110 from being twisted and deformed with respect to the living organ by the holding member 120 while the procedure is being performed. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

The number and arrangement of the deformation guiding portions 123 are not particularly limited. At least one set of deformation guiding portions 123 is provided at positions facing each other in each of the holding portions 121.

Further, the material of the deformation guiding portion 123 is not particularly limited. For example, it can be made of the same elastically deformable material as the pair of holding portions 121. Further, the material may be different from that of the pair of holding portions 121.

Further, the method of connecting the deformation guiding portion 123 and the main body portion 111 is not limited to the method of connecting the deformation guiding portion 123 and the main body portion 111 by partially inserting the deformation guiding portion 123 into the main body portion 111. For example, the deformation guiding portion 123 may be connected to the main body portion 111 by adhering to the front surface 113 or the back surface 114 of the main body portion 111.

As shown in FIG. 1, the pair of holding members 121 of the holding member 120 includes a first end portion 124 and a second end portion 125 forming a gap portion 122, and the holding member 120 includes a first end portion 124 and a first end portion 124. It has a first arm portion 126 and a second arm portion 127 extending outward from each of the two end portions 125 with respect to the pair of holding portions 121.

In the procedure of joining biological organs, the operator may not be able to reach the dorsal side (backside, posterior wall B1c of pancreatic parenchyma B1 in pancreatic parenchyma-jejunostomy) with respect to the circumferential direction of the biological organ. .. Therefore, as shown in FIGS. 6 and 7, the operator is from the ventral side (anterior wall B1d of the pancreatic parenchyma B1) with respect to the circumferential direction of the biological organ to the dorsal side (pancreatic parenchyma B1) with respect to the circumferential direction of the biological organ. The holding member 120 is sandwiched toward the rear wall B1c) (hereinafter, referred to as the sandwiching direction X). In this case, it is preferable that the operator can operate the pair of holding portions 121 on the ventral side with respect to the circumferential direction of the biological organ, that is, on the front side with respect to the sandwiching direction X.

As shown in FIG. 1, the first arm portion 126 and the second arm portion 127 approach and separate the tip 126a of the first arm portion and the tip 127a of the second arm portion located on the front side with respect to the sandwiching direction X. The first end portion 124 and the second end portion 125 can be brought close to each other and separated from each other according to the operating force F1. Thereby, the operator can receive at least a part of the living organ from the gap 122 to the pair of sandwiches 121 by the holding member 120.

Further, when the operator releases the tip 126a of the first arm portion and the tip 127a of the second arm portion, the width E1 of the gap portion 122 is narrowed by the elastic deformation of the pair of holding portions 121. Thereby, the operator can apply the holding force to the living organ to the main body portion 111 by the pair of holding portions 121. Therefore, the surgeon can prevent the fusion promoting sheet 110 from slipping off from the living organ by the holding member 120 while the procedure is being performed. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

The arrangement of the first arm portion 126 and the second arm portion 127 is not particularly limited as long as it extends outward from the pair of sandwiching portions 121. As shown in FIG. 1, the first arm portion 126 and the second arm portion 127 may not be formed with the first end portion 124 and the second end portion 125 of the pair of sandwiching portions 121 as the base ends, and the gap may be formed. It may be formed with a part of each sandwiching portion 121 other than the end portions 124 and 125 forming the portion 122 as the base end.

Further, the materials of the first arm portion 126 and the second arm portion 127 are not particularly limited. For example, it can be made of the same elastically deformable material as the pair of holding portions 121. Further, the material may be different from that of the pair of holding portions 121.

Further, the shapes of the first arm portion 126 and the second arm portion 127 are not particularly limited. For example, as shown in FIG. 1, it can be configured in a linear shape. The shapes of the first arm portion 126 and the second arm portion 127 can be variously deformed within a range that does not deviate from the gist thereof.

As described above, the medical device 100 according to the present embodiment sandwiches at least a part of the body portion 111 and at least a part of the living organ with the fusion promoting sheet 110 having the main body portion 111 that promotes the fusion of the living tissue. It is formed between a pair of elastically deformable holding portions 121 that hold the main body portion 111 with respect to the living organ, and a pair of holding portions 121, and accepts at least a part of the living organ between the pair of holding portions 121. A holding member having a gap portion 122 that enables the gap portion 122 and a deformation guiding portion 123 that expands and contracts the main body portion 111 in the surface direction as the gap portion 122 expands or narrows due to elastic deformation of the pair of sandwiching portions 121. Be prepared.

According to the medical device 100, the fusion of the biological tissues of the biological organs can be promoted by sandwiching the fusion promoting sheet 110 between the biological organs to be joined. Further, the holding member 120 can receive at least a part of the living organ between the gap portion 122 and the pair of holding portions 121, and can sandwich at least a part of the main body portion 111 and at least a part of the living organ. Further, the holding member 120 can hold the main body portion 111 against the living organ by utilizing the elasticity of the pair of holding portions 121. As a result, the surgeon can prevent the main body 111 from being displaced from the living organ or being twisted and deformed when the main body 111 is placed on the living organ by using the medical device 100. Therefore, the surgeon can prevent the union promoting sheet 110 from falling off from the living organ during the procedure.

In addition, the holding member 120 can expand and contract the main body 111 in the surface direction by the deformation guiding portion 123, and the fusion promoting sheet 110 can be brought into close contact with one of the jointed portions. Therefore, the surgeon attaches the fusion promoting sheet 110 to one of the joining sites with a fixing member such as a biodegradable suture (absorbent thread) or a staple while the fusion promoting sheet 110 is in close contact with one of the joined sites. Can be fixed. As a result, the surgeon can prevent the fusion promoting sheet 110 from being displaced or twisted from one of the jointed portions by using the medical device 100. From the above, the medical device 100 can effectively reduce the risk of suture failure of living organs.

Further, the pair of sandwiching portions 121 includes a first end portion 124 and a second end portion 125 forming a gap portion 122, and a holding member 120 is a pair from each of the first end portion 124 and the second end portion 125. It further has a first arm portion 126 and a second arm portion 127 extending outward from the holding portion 121. Further, the first arm portion 126 and the second arm portion 127 extend so as to form an acute angle with respect to the pair of holding portions 121, and the tip 126a of the first arm portion and the tip 127a of the second arm portion approach each other. The first end portion 124 and the second end portion 125 approach and separate from each other according to the operating force F1 that separates them.

According to the medical device 100 configured in this way, the operator operates the pair of holding portions 121 on the front side in the sandwiching direction X by operating the first arm portion 126 and the second arm portion 127. Can be done. Thereby, the operator can receive at least a part of the living organ from the gap 122 to the pair of sandwiches 121 by the holding member 120. Further, when the operator releases the tip 126a of the first arm portion and the tip 127a of the second arm portion, the width E1 of the gap portion 122 is narrowed by the elastic deformation of the pair of holding portions 121. Thereby, the operator can apply the holding force to the living organ to the main body portion 111 by the pair of holding portions 121. Therefore, the surgeon can prevent the fusion promoting sheet 110 from being displaced from the living organ and falling off by using the medical device 100 while the procedure is being performed. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

Further, the deformation guiding portion 123 is partially inserted into the main body portion 111. According to the medical device 100 configured in this way, the deformation guiding portion 123 is connected to the main body portion 111 by being partially inserted into the main body portion 111. The deformation guiding portion 123 can expand and contract the main body portion 111 connected to the deformation guiding portion 123 in the surface direction in accordance with the operation of expanding or narrowing the width E1 of the gap portion 122. As a result, the operator can bring the main body portion 111 into close contact with the cut surface of the biological organ by the deformation guiding portion 123. Further, the surgeon can fix the main body 111 to the cut surface of the biological organ with a fixing member such as a biodegradable suture (absorbent thread) or a staple while the main body 111 is in close contact with the cut surface of the biological organ. .. Therefore, the surgeon can prevent the fusion promoting sheet 110 from being twisted and deformed by using the medical device 100 while the procedure is being performed. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

Although the medical device 100 has been described above through the embodiments, the medical device 100 is not limited to the description of the above-described embodiment, and various modifications can be made without departing from the gist thereof. In the following description, deformation examples of the main body portion and the deformation induction portion will be described. In the description of the modified example, the description of the configuration and contents described in the above-mentioned medical device 100 will be omitted as appropriate. 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>
FIG. 3 is a perspective view showing a modified example of the main body portion and the deformation guiding portion in the medical device 100A.

As shown in FIG. 3, the medical device 100A includes a fusion promoting sheet 110A having a main body 111A formed from a biodegradable sheet having a plurality of through holes 112 and promoting fusion of biological tissues, and at least one of the main body 111A. Between a pair of elastically deformable sandwiching portions 121 that sandwich at least a part of a portion and a biological organ and holding the main body portion 111A with respect to the biological organ, and a pair of sandwiching portions, which are formed between the pair of sandwiching portions 121. Deformation guiding portion 123A that expands and contracts the main body portion 111A in the plane direction as the gap portion 122 that can accept at least a part of the biological organ and the gap portion 122 due to elastic deformation of the pair of holding portions 121 are widened or narrowed. A holding member 120A having the above.

The pair of holding portions 121 includes a first end portion 124 and a second end portion 125 forming a gap portion 122, and the holding member 120 is a pair of holding portions from each of the first end portion 124 and the second end portion 125. It further has a first arm portion 126 and a second arm portion 127 extending outward from the 121, and the first arm portion 126 and the second arm portion 127 have an acute angle with respect to the pair of holding portions 121. The first end portion 124 and the second end portion 125 approach and separate from each other according to the operating force F1 which extends so as to form and the tip 126a of the first arm portion and the tip 127a of the second arm portion approach and separate from each other. ..

The main body portion 111A further has a receiving portion 117 formed on the main body portion 111A, and the deformation inducing portion 123A is housed in the receiving portion 117.

As shown in FIG. 3, the deformation guiding portion 123A is a partial range of a pair of holding portions 121 and each arm portion 126, 127 formed in the main body portion 111A and accommodated in the receiving portion 117. A set of deformation guiding portions 123A is provided at different positions of the pair of sandwiching portions 121. Each deformation guiding portion 123 is provided at a position facing each other in each holding portion 121. When the pair of sandwiching portions 121 have a symmetrical shape via the gap portion 122, they face each other with respect to the virtual symmetrical line L3 passing through the center position O of the main body portion 111. It is a place.

As shown in FIG. 3, the deformation guiding portion 123A is connected to the main body portion 111 by accommodating the deformation guiding portion 123A in the receiving portion 117 formed in the main body portion 111A. As a result, in accordance with the operation of expanding or narrowing the width E1 of the gap portion 122, the width of each deformation guiding portion 123A provided at the opposite positions on the virtual left-right symmetry line L3 is expanded or narrowed. It can be narrowed down. Therefore, the deformation guiding portion 123A can expand and contract the main body portion 111 in the surface direction.

The holding member 120A can expand and contract the main body 111 in the surface direction by the deformation guiding portion 123, and the main body 111 can be brought into close contact with the cut surface of the living organ. Therefore, the operator can fix the main body 111 to the cut surface of the biological organ with a fixing member such as a biodegradable suture (absorbent thread) or a staple while the main body 111 is in close contact with the cut surface of the biological organ. .. Thereby, the operator can prevent the fusion promoting sheet 110A from being twisted and deformed with respect to the living organ by the holding member 120A while the procedure is being performed. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

Further, as shown in FIG. 3, the shape of each arm portion 126, 127 constituting the deformation guiding portion 123A is a waveform. As a result, each of the arm portions 126 and 127 constituting the deformation guiding portion 123A can generate sliding resistance at least partially with respect to the receiving portion 117 formed in the main body portion 111A. Therefore, when the operator brings the first end portion 124 and the second end portion 125 closer to each other according to the operating force F1 that brings the tip 126a of the first arm portion and the tip 127a of the second arm portion closer to each other, It is possible to prevent the deformation guiding portion 123A from falling off from the receiving portion 117. Therefore, the surgeon can effectively reduce the risk of suture failure of living organs.

The material of the receiving unit 117 is not particularly limited. For example, it can be made of the same material as the main body 111A. Further, the constituent material may be different from that of the main body 111A.

Further, the arrangement of the receiving unit 117 is not particularly limited. For example, the receiving portion 117 may be provided symmetrically as shown in FIG. 3, or may be partially provided along the peripheral edge 116 of the main body portion 111A.

As described above, the main body 111A of the medical device 100A according to the first modification further has a receiving portion 117 formed on the main body 111A, and the deformation guiding portion 123A of the holding member 120A is housed in the receiving portion 117. Has been done.

According to the medical device 100 configured in this way, the deformation guiding portion 123A is connected to the main body portion 111 by accommodating the deformation guiding portion 123A in the receiving portion 117 formed in the main body portion 111A. As a result, the deformation guiding portion 123A can expand and contract the main body portion 111A in the surface direction in accordance with the operation of expanding or narrowing the width E1 of the gap portion 122. As a result, the operator can bring the main body portion 111A into close contact with the cut surface of the living organ by the deformation guiding portion 123A. Further, the surgeon can fix the main body 111A to the cut surface of the biological organ with a fixing member such as a biodegradable suture (absorbent thread) or a staple while the main body 111A is in close contact with the cut surface of the biological organ. .. Therefore, the surgeon can prevent the fusion promoting sheet 110A from being twisted and deformed by using the medical device 100A while the procedure is being performed. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

Although an example of the configuration of the medical device has been described above, the description is not limited to the above embodiment, and various modifications can be made without departing from the gist thereof.

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

FIG. 4 is a flowchart showing each procedure of the treatment method using the medical device.

The treatment method is to place a medical device between one of the jointed parts to be joined and the other of the joined parts of the living organ (S11), and to have a sheet-like main body that promotes the fusion of the living tissue. Fixing the accelerating sheet to one of the jointed parts by a holding member (S12), and arranging at least a part of the main body of the fusion accelerating sheet between one of the joined parts and the other of the joined parts. Includes joining (S13) between the joined portion of the above and the other joined portion.

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. Further, as the medical device used in each of the procedures described below, for example, any of the above-mentioned medical devices can be selected, and other medical devices can also be selected. However, in the following description, a usage example of the medical device 100 shown in FIG. 1 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 a medical device between biological organs" means that the medical device is arranged in a state of direct or indirect contact with the biological organ, and between the biological organs. The medical device is placed with a spatial gap formed in the living organ, or the medical device is placed in both states (for example, the medical device comes into contact with one living organ and the other living organ). Means at least one of the medical devices being placed in contact with each other. Further, in the description of the present specification, the term "periphery" does not define a strict range (region), but a predetermined range (region) as long as the purpose of treatment (bonding between biological organs) can be achieved. Means. In addition, the order of the procedure procedures described in each treatment method can be changed as appropriate as long as the purpose of the treatment can be achieved. Further, in the description of the present specification, "relatively approaching" means both bringing two or more objects to be approached close to each other and bringing only one close to the other.

<Example of treatment method (pancreatic parenchyma-jejunal anastomosis)>
FIG. 5 is a flowchart showing the procedure of the embodiment of the treatment method (pancreatic parenchymal-jejunal anastomosis), and FIGS. 6 to 13 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.

As shown in FIG. 5, the treatment method according to the present embodiment is to dispose the medical device 100 between the pancreatic parenchyma B1 to be joined and the jejunum (S101), and promote the fusion of living tissues among the medical devices 100. The fusion promoting sheet 110 including the sheet-shaped main body 111 is fixed to the pancreatic parenchyma B1 by the holding member 120 (S102), the fusion promoting sheet 110 is sandwiched between the pancreatic parenchyma B1 and the jejunum B2 (S103), and the pancreas. It includes joining with the fusion promoting sheet 110 sandwiched between the parenchyma B1 and the jejunum B2 (S104), and placing the fusion promoting sheet 110 between the pancreatic parenchyma B1 and the jejunum B2 (S105).

Next, an example of the treatment method according to the present embodiment will be specifically described with reference to FIGS. 6 to 13. In FIG. 11, a plurality of both end needles 920a to 920e, which will be described later, are omitted.

As shown in FIG. 6, the surgeon arranges the medical device 100 so that the back surface 114 of the fusion promoting sheet 110 faces the cut surface B1a of the cut pancreatic parenchyma B1.

The specific procedure for arranging the medical device 100 on the cut surface B1a of the pancreatic parenchyma B1 is not particularly limited, but can be performed by, for example, the following 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.

At this time, the operator operates the first arm portion 126 and the second arm portion 127 to widen or narrow the gap portion 122 of the holding member 120. Then, in accordance with the operation of expanding or narrowing the width E1 of the gap portion 122, the operator expands and contracts the main body portion 111 in the surface direction by the deformation guiding portion 123. Further, as shown in FIG. 6, the operator sandwiches the holding member 120 into the pancreatic parenchyma B1 along the sandwiching direction X. As a result, the holding member 120 can receive the anterior wall B1d of the pancreatic parenchyma B1 (the ventral portion in the circumferential direction of the pancreatic parenchyma B1) between the gap portion 122 and the pair of sandwiching portions 121. As a result, the operator can bring the fusion promoting sheet 110 into close contact with the cut surface B1a of the pancreatic parenchyma B1 by the deformation guiding portion 123. In addition, the holding member 120 can hold the main body 111 with respect to the pancreatic parenchyma B1.

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 medical device 100 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 medical device 100 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 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. 7, the operator holds the fusion promoting sheet 110 with respect to the pancreatic parenchyma B1 by the holding member 120, and the operator holds the posterior wall B1c of the pancreatic parenchyma B1 (the dorsal side of the pancreatic parenchyma B1 in the circumferential direction). 920a at both ends toward the anterior wall B1d of the pancreatic parenchyma B1 and the portion arranged on the anterior wall B1d of the union promoting sheet 110 from the portion arranged on the posterior wall B1c of the union promoting sheet 110. Move the hands. 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. 8, 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.

Next, the operator removes the holding member 120 by fixing the fusion promoting sheet 110 to the cut surface B1a of the pancreatic parenchyma B1 and then cutting off a part of the main body portion 111 connected to the deformation guiding portion 123. Thereby, the operator prevents the fusion promoting sheet 110 from being displaced from the living organ and falling off from the living organ by the holding member 120 until the fusion promoting sheet 110 is fixed to the cut surface B1a of the pancreatic parenchyma B1. It is possible to effectively reduce the risk of suture failure of living organs.

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. 8, the operator passes both ends of the needle 930 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. 8 and 10, 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. 9 and 10, the operator inserts the other end of the needles 940a at both ends into the through hole B2a of the jejunum B2, and the needles 940a at both ends toward the outside of the jejunum B2 from the inside of the jejunum B2. Move the other end. Then, as shown in FIG. 11, 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.

Next, as shown in FIG. 11, 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. 13, 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 during suturing so as to wrap the cut surface B1a of the pancreatic parenchyma B1 and the main body 111 of the fusion promoting sheet 110.

The operator places the fusion promoting sheet 110 in a state where the main body 111 of the medical device 100 is sandwiched between the cut surface B1a of the pancreatic parenchyma B1 and the intestinal wall of the jejunum B2. The main body 111 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 biological tissue of the intestinal wall of the jejunum B2 are formed by the main body 111 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. Can promote fusion and reduce the risk of suture failure after pancreatic parenchymal-jejunostomy.

Further, in the medical device 100 used in the above treatment method, the operator operates the tip 126a of the first arm portion and the tip 127a of the second arm portion to widen or narrow the gap portion 122 of the holding member 120. can do. Then, the operator can expand and contract the main body portion 111 in the surface direction in accordance with the operation of expanding or narrowing the width E1 of the gap portion 122. Therefore, when accepting the cut surface of the pancreatic parenchyma B1 between the gap portion 122 and the pair of sandwiching portions 121 and sandwiching at least a part of the main body portion 111 and at least a part of the pancreatic parenchyma B1 along the sandwiching direction X, the operation is performed. One can bring the fusion promoting sheet 110 into close contact with the cut surface B1a of the pancreatic parenchyma B1. As a result, the operator fixes the fusion promoting sheet 110 to the cut surface B1a of the pancreatic parenchyma B1 with the fixing member both ends needles 920a to 920e) in a state where the fusion promoting sheet 110 is in close contact with the cut surface B1a of the pancreatic parenchyma B1. Can be done.

Further, the operator removes the holding member 120 by fixing the fusion promoting sheet 110 to the cut surface B1a of the pancreatic parenchyma B1 and then cutting off a part of the main body portion 111 connected to the deformation guiding portion 123. As a result, until the fusion promoting sheet 110 is fixed to the cut surface B1a of the pancreatic parenchyma B1, the holding member 120 suppresses the fusion promoting sheet 110 from being displaced from the pancreatic parenchyma B1 or being twisted and deformed. Can be done. Therefore, the operator can effectively reduce the risk of suture failure of the living organ.

100, 100A medical device,
110, 110A fusion promotion sheet,
111 body,
112 through hole,
113 surface (the other surface),
114 Back side (one side),
116 The periphery of the main body,
117 Receptor,
120 holding member,
121 Holding part,
122 Gap,
123, 123A Deformation induction part,
124 1st end,
125 Second end,
126 1st arm,
126a Tip of the first arm,
127 2nd arm,
127a The tip of the second arm,
130 holes,
B1 pancreatic parenchyma,
B2 jejunum,
E1 Gap width,
Maximum width of E2 body,
F1 Operating force that brings the tip of the first arm and the tip of the second arm closer to each other,
L1, L2 virtual symmetry line,
L3 virtual symmetrical line,
X sandwiching direction.

Claims (4)

A fusion promotion sheet with a main body that promotes fusion of living tissues,
It is formed between a pair of elastically deformable sandwiches that sandwich at least a part of the main body and at least a part of a biological organ and hold the body with respect to the biological organ, and the pair of sandwiches. A gap portion that allows at least a part of the biological organ to be received between the pair of holding portions, and the main body portion in the plane direction as the gap portion is widened or narrowed due to elastic deformation of the pair of holding portions. A medical device comprising: a deformation guiding portion that expands and contracts in a manner, and a holding member having. The pair of sandwiching portions includes a first end portion and a second end portion forming the gap portion.
The holding member further includes a first arm portion and a second arm portion extending outward from the pair of holding portions from each of the first end portion and the second end portion.
The first arm portion and the second arm portion extend so as to form an acute angle with respect to the pair of sandwiching portions.
The claim is characterized in that the first end portion and the second end portion approach and separate from each other according to an operating force that causes the tip of the first arm portion and the tip of the second arm portion to approach and separate from each other. The medical device according to 1. The medical device according to claim 1 or 2, wherein the deformation guiding portion is partially inserted into the main body portion. The main body portion further has a receiving portion formed on the main body portion.
The medical device according to claim 2, wherein the deformation-inducing portion is housed in the receiving portion.