Patent Description:
<CIT> relates to an apparatus for joining two hollow organ sections with an annular array of surgical staples includes a staple cartridge, an anvil, a buttress member, and a buttress mount.

<CIT>relates to an annular gasket for use with a circular stapling apparatus in performing an anastomosis. The annular gasket comprises a substantially circular body portion having an upper surface, a lower surface, an outer terminal edge, and an inner terminal edge defining an aperture therein.

<CIT> relates to an apparatus for forming an anastomosis between adjacent intestinal sections of tissue. The apparatus includes an anastomosis device having an anvil and a tubular body portion, wherein the anvil is selectively attachable to the tubular body portion by a shaft, and a support structure for deposition between the intestinal sections of tissue.

In a medical field, a medical procedure (for example, anastomosis for a digestive tract) of joining biological organs to each other by performing a surgical operation is known. In a case where the medical procedure as described above is performed, as a prognosis determinant after surgery, a fact is important that there is no delay in adhesion in a joint portion joined between the biological organs.

In the medical procedure of joining the biological organs, various methods and various medical instruments are used. For example, a method of suturing the biological organs by using a biodegradable suture, or a method of using a mechanical anastomosis device (refer to PTL <NUM>) for suturing the biological organs by using a stapler has been proposed. In particular, in a case where anastomosis is performed using the mechanical anastomosis device, compared to a method of using the suture, a joining force between the biological organs can be improved in the joint portion. Accordingly, risk factors of an anastomotic leakage can be reduced.

However, a progress degree of the adhesion in the joint portion depends on a state of biological tissues in a joint object site (joint target site) of a patient. Therefore, for example, even in a case where the anastomosis device as disclosed in PTL <NUM> is used, depending on the state of the biological tissues of the patient, there is a possibility that the risk factors of the anastomotic leakage cannot be sufficiently reduced.

Therefore, the present invention aims to provide an adhesion promotion device capable of reducing risk factors of an anastomotic leakage after a surgical operation is performed.

According to an embodiment of the present invention, there is provided an adhesion promotion device according to claim <NUM>.

According to the present invention, an adhesion promotion device can improve rigidity of a main body portion by a reinforcement portion, and can prevent distortion or misalignment from occurring. In this manner, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device during an operation (when the adhesion promotion device indwells a body). In addition, in a case where any force is applied after indwelling, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device. Therefore, it is possible to reduce risk factors of an anastomotic leakage after a surgical operation is performed.

Hereinafter, an embodiment of the present invention will be described with reference to each drawing. Dimensional proportions in the drawings are exaggerated and different from actual proportions for convenience of description, in some cases.

<FIG> is a perspective view illustrating a form of an adhesion promotion device <NUM>, and <FIG> is a perspective view illustrating a main body portion <NUM> of the adhesion promotion device <NUM> illustrated in <FIG>. <FIG> is a cross-sectional view taken along line <NUM>-<NUM> in <FIG>, and <FIG> is an enlarged cross-sectional view illustrating a portion of the main body portion <NUM>.

For example, the illustrated adhesion promotion device <NUM> can be used for a method of joining a predetermined site serving as a joint object of a biological organ (for example, anastomosis of a digestive tract). In general, the adhesion promotion device <NUM> has the main body portion <NUM> formed of a biodegradable sheet having a plurality of through-holes <NUM> and promoting adhesion of biological tissues, and a reinforcement portion <NUM> disposed in a portion of the main body portion <NUM> and reinforcing the main body portion <NUM>. Hereinafter, configurations will be described in detail.

The main body portion <NUM> can be formed of the biodegradable sheet having a thin film shape. The main body portion <NUM> has a plurality of the through-holes <NUM>. As illustrated in <FIG>, the plurality of through-holes <NUM> are regularly and cyclically provided in a plane direction of the main body portion <NUM>. For example, the plurality of through-holes <NUM> may be randomly provided in the main body portion <NUM>.

As illustrated in <FIG>, the plurality of through-holes <NUM> are vertically provided along a thickness direction (upward-downward direction in <FIG>) of the main body portion <NUM>. The plurality of through-holes <NUM> are substantially vertically provided between a front surface <NUM> and a rear surface <NUM> of the main body portion <NUM>. However, the plurality of through-holes <NUM> may be provided to be curved between the front surface <NUM> and the rear surface <NUM> in the thickness direction of the main body portion <NUM>.

A thickness of the main body portion <NUM> (size T illustrated in <FIG>) is not particularly limited. The thickness is preferably <NUM> to <NUM>, and more preferably <NUM> to <NUM>. When the thickness of the main body portion <NUM> is <NUM> or thicker (particularly, <NUM> or thicker), sufficient strength can be ensured to such an extent that the main body portion <NUM> is not damaged when the adhesion promotion device <NUM> is handled. On the other hand, when the thickness of the main body portion <NUM> is <NUM> or thinner (particularly, <NUM> or thinner), the main body portion <NUM> closely adheres to a biological tissue to which the main body portion <NUM> is applied, and it is possible to ensure sufficient flexibility to follow the biological tissue.

As illustrated in <FIG>, the main body portion <NUM> has a circular shape in a plan view. However, an outer shape of the main body portion <NUM> is not particularly limited, and may be a substantially rectangular shape or an elliptical shape, for example.

In the main body portion <NUM>, a ratio value of a hole diameter D (distance D illustrated in <FIG>) of the plurality of through-holes <NUM> to a pitch P (distance P illustrated in <FIG>) of the plurality of through-holes <NUM> is preferably <NUM> or greater and smaller than <NUM>. When a shape of the through-hole <NUM> is a perfect circle in a plan view, the hole diameter D of the through-hole <NUM> is equal to a diameter of the perfect circle. On the other hand, in a case where the through-hole <NUM> is not the perfect circle in a plan view, the diameter (equivalent circle diameter) of the perfect circle having an area the same as an area of an opening portion (portion facing the front surface <NUM> or the rear surface <NUM> in the through-hole <NUM>) of the through-hole <NUM> can be set as the hole diameter D of the through-hole <NUM>.

In addition, the main body portion <NUM> has the plurality of through-holes <NUM>. Therefore, the main body portion <NUM> has a plurality of values of the hole diameters D corresponding to the respective through-holes <NUM>. In the present embodiment, in calculating the above-described ratio value, an arithmetic average value of two or more values of the hole diameter D corresponding to each of the plurality of through-holes <NUM> is used as a representative value of the hole diameter D. On the other hand, the "pitch P" of the plurality of through-holes <NUM> means a shortest distance between the opening portions of the two through-holes <NUM>. With regard to the value of the pitch P, there are a plurality of values of the pitch P corresponding to a combination of the through-holes <NUM> adjacent to each other. Therefore, according to the present embodiment, in calculating the above-described ratio value, the arithmetic average value of two or more values of the pitch P corresponding to each combination of the through-holes <NUM> adjacent to each other is used as a representative value of the pitch P.

The pitch P of the above-described through-holes <NUM>, the hole diameter D, and the ratio of the hole diameter D to the pitch P are merely examples, and the present invention is not limited thereto.

The main body portion <NUM> can be formed of a biodegradable material. A configuration material of the main body portion <NUM> is not particularly limited. For example, a biodegradable resin may be used. As the biodegradable resin, for example, it is possible to use a known biodegradable (co)polymer such as those disclosed in <CIT>, <CIT>, Pamphlet of International Publication No. <CIT>, and <CIT>. Specifically, the biodegradable resin includes (<NUM>) a polymer selected from a group formed of aliphatic polyester, polyester, polyanhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose; or (<NUM>) copolymer configured to include one or more monomers configuring the above-described materials (<NUM>). That is, it is preferable that the biodegradable sheet includes the polymer selected from a group formed of aliphatic polyester, polyester, polyanhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose, and at least one biodegradable resin selected from a group formed of the copolymer configured to include one or more monomers configuring the polymer.

A manufacturing method of the main body portion <NUM> is not particularly limited. For example, the manufacturing method includes a method of preparing a fiber formed of the above-described biodegradable resin and manufacturing a mesh-shaped sheet by using the fiber. A method of preparing the fiber formed of the biodegradable resin is not particularly limited. For example, the method includes an electrospinning method (electric field spinning method and electrostatic spinning method) or a melt blowing method. As the method for the main body portion <NUM>, only one of the above-described methods may be selected and used. Alternatively, two or more methods may be used in appropriate combination with each other.

Here, the electrospinning method is a method of forming fine fibers formed of a resin in a state where a high voltage (for example, approximately <NUM> kV) is applied between a syringe filled with a resin solution and a collector electrode. When the method is adopted, the solution extruded from the syringe is charged and scattered in an electric field. However, a solvent contained in the scattered solution evaporates with the lapse of time. Accordingly, as a result, a thinned solute appears. The thinned solute becomes fine fibers formed of the resin, and adheres to a collector of basal lamellas.

A mesh-shaped base material formed of stainless steel (SUS) is used as the collector of the electrospinning method. In this manner, the fine fibers formed of the biodegradable resin which serves as the thinned solute adhere to a substantial portion of a mesh, thereby forming the mesh formed of the fine fibers. The biodegradable sheet can be manufactured by separating the resin mesh obtained in this way from the mesh-shaped base material. A size (a hole diameter or a pitch) of the mesh-shaped base material is appropriately adjusted. In this manner, it is possible to control a shape (a hole diameter or a pitch of the through-hole) of the biodegradable sheet formed of the manufactured resin mesh.

In addition, as another example of the manufacturing method of similarly using the electrospinning method, the above-described solution is scattered on a front surface of a flat base material having no mesh shape, and the fine fibers are adhered thereto. In this manner, it is possible to adopt a method of forming the through-hole after obtaining the resin sheet having a uniform thickness. In this case, for example, the resin sheet is irradiated with a laser beam focused by using a condenser lens. In this manner, the through-hole can be formed in an irradiation site. Then, energy or an irradiation time of the laser beam to be used for the irradiation, and an interval between the irradiation sites are adjusted. In this manner, it is possible to control the shape (the hole diameter or the pitch of the through-hole) of the biodegradable sheet formed of the manufactured resin mesh.

As still another example of the manufacturing method of the main body portion <NUM>, a fiber formed of the above-described biodegradable resin may be spun in accordance with a usual method, and the obtained fiber may be knitted into a mesh shape to manufacture the biodegradable sheet.

The main body portion <NUM> causes a biological reaction by using the configuration materials such as the biodegradable resin configuring the main body portion <NUM>. Due to this action, the main body portion <NUM> induces expression of biological components such as fibrin. The biological components induced in this way can promote adhesion by being accumulated to penetrate the through-holes <NUM> of the main body portion <NUM>. For example, the main body portion <NUM> of the adhesion promotion device <NUM> is disposed between the biological organs serving as the joint object (anastomosis object), thereby promoting the adhesion by using the above-described mechanism.

The main body portion <NUM> has a hole portion <NUM> (center hole) whose hole diameter d1 is larger than that of the through-hole <NUM> at a substantially central position when viewed in a plan view. For example, the hole diameter of the hole portion <NUM> can be formed to be <NUM> to <NUM>. In addition, an outer shape of the hole portion <NUM> can be a perfect circle, for example. However, the hole portion <NUM> may have an elliptical shape, a rectangular shape, or other shapes.

As illustrated in <FIG> and <FIG>, the reinforcement portion <NUM> is disposed in a portion of the main body portion <NUM>. The reason that the reinforcement portion <NUM> is disposed in a portion of the main body portion <NUM> is as follows. In a case where the reinforcement portion <NUM> is provided on an entire surface of the main body portion <NUM>, a function of promoting the adhesion which is an original function of the main body portion <NUM> cannot be achieved. The reinforcement portion <NUM> is disposed on one surface (front surface <NUM>) out of both the front surface and the rear surface of the main body portion <NUM>. Since the main body portion <NUM> is formed of the mesh sheet, the main body portion <NUM> is extremely soft. In a case of using only the main body portion <NUM>, distortion or misalignment is likely to occur in the adhesion promotion device. Therefore, there is a possibility that the distortion or the misalignment may occur in the adhesion promotion device during an operation (when the adhesion promotion device indwells a body). In addition, even after the indwelling, there is a possibility that the distortion or the misalignment may occur in the adhesion promotion device due to some reasons.

Therefore, in the adhesion promotion device <NUM> of the present embodiment, rigidity of the main body portion <NUM> is improved by disposing the reinforcement portion <NUM> in a portion of the main body portion <NUM>. Accordingly, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>. In this manner, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM> during the operation (when the adhesion promotion device <NUM> indwells a body). In addition, in a case where any force is applied after the indwelling, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>.

The reinforcement portion <NUM> includes a first reinforcement portion <NUM> located on an outer edge side of the main body portion <NUM> and a second reinforcement portion <NUM> located on an inner peripheral edge side of the hole portion <NUM>. In the main body portion <NUM>, the rigidity of the outer edge side is improved by the first reinforcement portion <NUM>, and the rigidity of the inner peripheral edge side of the hole portion <NUM> is improved by the second reinforcement portion <NUM>. When a medical instrument is inserted into the hole portion <NUM>, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>.

The reinforcement portion <NUM> is not limited to a case where the two first and second reinforcement portions <NUM> and <NUM> are provided. One reinforcement portion <NUM> can be located only on the outer edge side of the main body portion <NUM>, or can be located only on the inner peripheral edge side of the hole portion <NUM>. In addition, the reinforcement portion <NUM> can be configured to include three or more reinforcement portions <NUM>.

The second reinforcement portion <NUM> can be stronger than the first reinforcement portion <NUM> in reinforcing the biodegradable sheet forming the main body portion <NUM>. Since the rigidity of the inner peripheral edge side of the hole portion <NUM> is further improved, it is possible to further prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM> when a medical instrument is inserted into the hole portion <NUM>.

The first reinforcement portion <NUM> and the second reinforcement portion <NUM> can have the same strength in reinforcing the main body portion <NUM>.

A material of the reinforcement portion <NUM> is not particularly limited. However, for example, a biocompatible adhesive or a coating agent formed of a thermoplastic resin can be used. In addition, a material the same as that of the main body portion <NUM> can be used.

The thickness of the reinforcement portion <NUM> is not particularly limited. The reinforcement portion <NUM> is provided in order to reinforce the main body portion <NUM>, and the reinforcement portion <NUM> does not need to be flexible or elastic. Therefore, the reinforcement portion <NUM> does not need to be thicker than necessary, and for example, an intended purpose can be achieved by the thickness of smaller than <NUM>.

A preparation method of the reinforcement portion <NUM> is not particularly limited, and a preparation method suitable for the configuration material of the reinforcement portion <NUM> can be adopted. For example, in a case of using the biocompatible adhesive or the coating agent, the reinforcement portion <NUM> can be prepared by applying the biocompatible adhesive or the coating agent from a nozzle to a portion of the main body portion <NUM> and drying the applied portion. In addition, a layer including the reinforcement portion <NUM> is formed separately from the main body portion <NUM>, and a reinforcement portion layer thereof is integrated with the main body portion <NUM> by means of crimping or heat-welding. In this manner, the reinforcement portion can be prepared.

Conditions for specifying the shape of the reinforcement portion <NUM> will be described with reference to <FIG>.

In the adhesion promotion device <NUM> illustrated in <FIG>, the main body portion <NUM> and the reinforcement portion <NUM> have a quadrangular shape. For convenience of description, sides configuring the reinforcement portion <NUM> having the quadrangular shape are defined as 33a to 33d. First, a virtual circle <NUM> (<FIG>) inscribed with the main body portion <NUM> or a virtual circle <NUM> (<FIG>) circumscribed with the main body portion <NUM> is assumed. It is preferable that the reinforcement portion <NUM> intersects with a line segment <NUM> extending from a center <NUM> of the assumed virtual circle <NUM> at least at one location. In the illustrated example, the line segment <NUM> extending from the center <NUM> of the virtual circle <NUM> and the side 33a of the reinforcement portion <NUM> intersect with each other at a point Pc. In a case of adopting this form, the rigidity of the main body portion <NUM> is improved by the side 33a of the reinforcement portion <NUM>. For example, even in a case where a force F of pushing down or pulling up the main body portion <NUM> in a direction orthogonal to a paper surface of the drawing is applied to the point Pc, the side 33a of the reinforcement portion <NUM> is less likely to be bent. Therefore, in the adhesion promotion device <NUM>, the distortion or the misalignment is prevented from occurring against the force F.

Various forms of the shape of the reinforcement portion <NUM> in the adhesion promotion device will be described with reference to <FIG>, <FIG>, <FIG>.

The reinforcement portion <NUM> in an adhesion promotion device 10A in <FIG> includes the first reinforcement portion <NUM> located on the outer edge side of the main body portion <NUM> and the second reinforcement portion <NUM> located on the inner peripheral edge side of the hole portion <NUM>. Both the first reinforcement portion <NUM> and the second reinforcement portion <NUM> have a closed ring shape.

The reinforcement portion <NUM> in an adhesion promotion device 10B in <FIG> is located only on the inner peripheral edge side of the hole portion <NUM>, and has a closed ring shape.

The reinforcement portion <NUM> in an adhesion promotion device 10C in <FIG> is located only on the outer edge side of the main body portion <NUM>, and has a closed ring shape.

The reinforcement portion <NUM> in an adhesion promotion device 10D in <FIG> includes the first reinforcement portion <NUM> located on the outer edge side of the main body portion <NUM> and the second reinforcement portion <NUM> located on the inner peripheral edge side of the hole portion <NUM>. The first reinforcement portion <NUM> extends in a circular shape with a gap, and has an open ring shape. The second reinforcement portion <NUM> has a closed ring shape.

The reinforcement portion <NUM> in an adhesion promotion device 10E in <FIG> includes two reinforcement portions 35a and 35b located close to the outer edge side of the main body portion <NUM>. The two reinforcement portions 35a and 35b are concentrically located, and both have an open ring shape. When viewed from the center <NUM> of the virtual circle <NUM>, a gap in the reinforcement portion 35a located outside in the radial direction is hidden by the reinforcement portion 35b located inside in the radial direction. On the other hand, when viewed from the center <NUM> of the virtual circle <NUM>, a gap in the reinforcement portion 35b located inside in the radial direction is hidden by the reinforcement portion 35a located outside in the radial direction.

The reinforcement portion <NUM> in an adhesion promotion device 10F in <FIG> has a closed rectangular shape.

The reinforcement portion <NUM> in an adhesion promotion device <NUM> in <FIG> has a radial shape extending in the radial direction from the center <NUM> of the virtual circle <NUM>.

All of the reinforcement portions <NUM> are disposed in a portion of the main body portion <NUM>. Therefore, all of the through-holes <NUM> are not blocked, and the main body portion <NUM> can sufficiently achieve a function of promoting the adhesion which is an original function.

The reinforcement portion <NUM> illustrated in <FIG> intersects with the line segment <NUM> extending from the center <NUM> of the virtual circle <NUM> inscribed or circumscribed with the main body portion <NUM> at two locations. The reinforcement portion <NUM> illustrated in <FIG> intersects with the line segment <NUM> at one location. The reinforcement portion <NUM> illustrated in <FIG> intersects with the line segment <NUM> at two locations in one direction of the line segment <NUM>, and intersects with the line segment <NUM> at one location in the other direction. The reinforcement portion <NUM> illustrated in <FIG> intersects with the line segment <NUM> at one location. The reinforcement portion <NUM> illustrated in <FIG> extends on the line segment <NUM>, and a width direction of the reinforcement portion <NUM> is a direction intersecting with the line segment <NUM>. Therefore, all of the reinforcement portions <NUM> intersect with the line segment <NUM> extending from the center <NUM> of the virtual circle <NUM> at least at one location. Since the main body portion <NUM> has a circular shape, the virtual circle <NUM> coincides with an outer periphery of the main body portion <NUM>.

Except for the reinforcement portion <NUM> having a radial shape illustrated in <FIG>, the reinforcement portions <NUM> illustrated in <FIG>, <FIG>, and <FIG> intersect with the line segment <NUM> over the entire periphery of the virtual circle <NUM> in a circumferential direction. That is, in a case where the line segment <NUM> is rotated once (<NUM> degrees) around the center <NUM> of the virtual circle <NUM>, the reinforcement portion <NUM> intersects with the line segment <NUM> in any direction. In other words, the reinforcement portions <NUM> have a shape that forms a closed region internally including the center <NUM> of the virtual circle <NUM>. Since the reinforcement portion <NUM> intersects with the line segment <NUM> over the entire periphery of the virtual circle <NUM> in the circumferential direction, the reinforcement portion <NUM> is less likely to be bent even when the force F is applied along any direction. Therefore, the adhesion promotion device <NUM> can prevent the distortion or the misalignment from occurring against the force F applied along any direction.

The reinforcement portion <NUM> illustrated in <FIG> includes a portion having an open ring shape. However, all of the reinforcement portions <NUM> have a shape overlapping in an extending direction of the line segment <NUM>. Even when the portion having this open ring shape is included, the reinforcement portion <NUM> intersecting with the line segment <NUM> can be formed over the entire periphery of the virtual circle <NUM> in the circumferential direction.

A form of the hole portion <NUM> formed in the main body portion <NUM> of adhesion promotion devices <NUM> and 10J will be described with reference to <FIG>.

The hole portion <NUM> illustrated in <FIG> is a center hole formed concentrically with the center <NUM> of the virtual circle <NUM> inscribed or circumscribed with the main body portion <NUM>. The hole portion <NUM> illustrated in <FIG> is formed at an eccentric position from the center <NUM> of the virtual circle <NUM>. In this way, the hole portion <NUM> can be formed at a desired position in the main body portion <NUM>.

Another form of the adhesion promotion device will be described with reference to <FIG>, <FIG>.

As illustrated in <FIG>, <FIG>, adhesion promotion devices <NUM> and <NUM> may not have the hole portion <NUM> formed in the main body portion <NUM>.

The main body portion <NUM> is not limited to a case having a circular shape in a plan view. As illustrated in <FIG>, an outer shape of a main body portion 20A can be a substantially rectangular shape.

The reinforcement portion <NUM> in the adhesion promotion device <NUM> illustrated in <FIG> is located only on the outer edge side of the main body portion <NUM>, and has a closed ring shape. The reinforcement portion <NUM> in the adhesion promotion device <NUM> illustrated in <FIG> is located only on the outer edge side of the main body portion 20A, and has a closed and substantially rectangular shape.

Another form of the shape of the main body portion in the adhesion promotion device will be described with reference to <FIG>.

The outer shape of the main body portions <NUM> and 20A is not limited to the above-described circular shape or substantially rectangular shape. The outer edge of the main body portion can have various shapes including a linear shape or an arc shape. For example, as illustrated in <FIG>, an outer edge of a main body portion 20B can have a polygonal shape (hexagonal shape in the illustrated example) including the linear shape. In addition, as illustrated in <FIG>, an outer edge of a main body portion 20C can have an elliptical shape including an arc shape. In addition, as illustrated in <FIG>, an outer edge of a main body portion 20D can have a track-like shape including both the linear shape and the arc shape.

Another form of a cross-sectional structure of the adhesion promotion device will be described with reference to <FIG>.

The cross-sectional structure of the adhesion promotion device is not limited to a structure in which a layer including the reinforcement portion <NUM> (reinforcement portion layer) is integrated with one side of the main body portion <NUM> (refer to <FIG>).

For example, as illustrated in <FIG>, an adhesion promotion device <NUM> can have a cross-sectional structure in which a reinforcement portion layer 35c is integrated with both the front and rear surfaces <NUM> and <NUM> of the main body portion <NUM>. In addition, as illustrated in <FIG>, an adhesion promotion device 10N can have a cross-sectional structure in which the main body portion <NUM> is integrated with both surfaces of the reinforcement portion layer 35c. The reinforcement portion layer 35c and the main body portion <NUM> can be integrated by means of crimping or heat-welding.

A form of a manufacturing procedure of the reinforcement portion in adhesion promotion devices 10P and 10Q will be described with reference to <FIG>.

The reinforcement portion <NUM> in the adhesion promotion device <NUM> is not limited to a case where the reinforcement portion <NUM> is manufactured by integrating the layer including the reinforcement portion (reinforcement portion layer) and the main body portion <NUM> with each other.

For example, as illustrated in <FIG>, a biodegradable sheet material <NUM> before forming the through-hole <NUM> is prepared. Then, the through-hole <NUM> is formed in the biodegradable sheet material <NUM> to form the main body portion <NUM>, except for a region configuring a reinforcement portion 35d. Whereas the main body portion <NUM> has the plurality of through-holes <NUM>, the through-hole <NUM> is no formed in the reinforcement portion 35d. Therefore, the reinforcement portion 35d of the adhesion promotion device 10P has rigidity higher than that of the main body portion <NUM>, and can reinforce the main body portion <NUM>.

In addition, as illustrated in <FIG>, a biodegradable sheet <NUM> having the plurality of through-holes <NUM> is prepared. Then, only a region configuring a reinforcement portion 35e is compressed or heated in a thickness direction to crush the through-hole <NUM>. The through-hole <NUM> in the reinforcement portion 35e does not need to be completely extinguished. The through-holes <NUM> may be crushed and reduced, and configuration materials of the biodegradable sheet may be in a densely aggregated form. Whereas the main body portion <NUM> has the plurality of through-holes <NUM>, the through-holes <NUM> in the reinforcement portion 35e are crushed and reduced. Therefore, the reinforcement portion 35e of the adhesion promotion device 10Q has higher density. Accordingly, the rigidity is improved compared to the main body portion <NUM>, and the main body portion <NUM> can be reinforced.

A specific shape of a reinforcement portion in an adhesion promotion device <NUM> will be described with reference to <FIG>.

The reinforcement portion can have any desired shape including the linear shape, or the arc shape, as long as the reinforcement portion is disposed in a portion of the main body portion and achieves a function of reinforcing the main body portion. In all of the adhesion promotion devices <NUM> illustrated in <FIG>, a main body portion <NUM> has a circular shape in a plan view, and a hole portion <NUM> (center hole) is formed at a substantially central position when the main body portion <NUM> is viewed in a plan view.

The reinforcement portion <NUM> in <FIG> has an outer ring portion 103a located only on the outer edge side of the main body portion <NUM> and having a closed shape. The reinforcement portion <NUM> is configured to include a portion having an arc shape.

The reinforcement portion <NUM> in <FIG> has the outer ring portion 103a having the arc shape, and a rib portion 103b extending in the radial direction. The rib portion 103b extends toward the hole portion <NUM> from an inner periphery of the outer ring portion 103a, but does not reach the hole portion <NUM>. The reinforcement portion <NUM> is configured to include a portion having the arc shape and the linear shape.

In the reinforcement portion <NUM> in <FIG>, the rib portion 103c reaches an inner peripheral edge of the hole portion <NUM>, compared to <FIG>.

Compared to <FIG>, the reinforcement portion <NUM> in <FIG> has an inner ring portion 103d located on the inner peripheral edge side of the hole portion <NUM> and having a closed shape. The rib portion 103c connects the outer ring portion 103a and the inner ring portion 103d. The outer ring portion 103a corresponds to a first reinforcement portion <NUM>, and the inner ring portion 103d corresponds to a second reinforcement portion <NUM>.

Compared to <FIG>, the reinforcement portion <NUM> in <FIG> has an intermediate ring portion 103e located between the outer ring portion 103a and the inner ring portion 103d and having a closed shape. The rib portion 103c connects the outer ring portion 103a, the intermediate ring portion 103e, and the inner ring portion 103d.

The reinforcement portion <NUM> in <FIG> is configured to include a portion having the linear shape, and is formed in a shape like a spider web. The reinforcement portion <NUM> has a rib portion 103f extending in the radial direction, and a connection rib portion <NUM> connecting the adjacent rib portions 103f to each other. The rib portion 103f extends from the outer edge of the main body portion <NUM> to the inner peripheral edge of the hole portion <NUM>. The connection rib portion <NUM> forms an octagonal shape.

The reinforcement portion <NUM> in <FIG> is configured to include a portion having the linear shape. The reinforcement portion <NUM> has a vertical rib portion <NUM> extending in a vertical direction and a horizontal rib portion 103i extending in a horizontal direction in the drawing. The vertical rib portion <NUM> and the horizontal rib portion 103i are orthogonal to each other at least at one location. The vertical rib portion <NUM> and the horizontal rib portion 103i are formed so that width dimensions are substantially equal to each other.

Compared to <FIG>, in the reinforcement portion <NUM> in <FIG>, vertical rib portions 103j and <NUM> and a horizontal rib portion <NUM> have different width dimensions. The width dimension of the vertical rib portion 103j located on the inner peripheral edge side of the hole portion <NUM> and the width dimension of the horizontal rib portion <NUM> are larger than the width dimension of the vertical rib portion <NUM> located on the outer edge side of the main body portion <NUM>. The reinforcement portion <NUM> is configured to include the first reinforcement portion <NUM> located on the outer edge side of the main body portion <NUM> and the second reinforcement portion <NUM> located on the inner peripheral edge side of the hole portion <NUM>. Then, depending on a size of the width dimension, the second reinforcement portion <NUM> is stronger than the first reinforcement portion <NUM> in reinforcing the biodegradable sheet forming the main body portion <NUM>.

The reinforcement portion <NUM> in <FIG> is configured to include a portion having the linear shape. The reinforcement portion <NUM> is formed in such a way that a plurality of linear rib portions 103n are connected to form a triangular shape, a quadrangular shape, and a hexagonal shape.

The reinforcement portion <NUM> in <FIG> is formed in such a way that a plurality of linear rib portions 103p are connected to form a honeycomb structure.

The reinforcement portion <NUM> in <FIG> is configured to include a portion having the linear shape. The reinforcement portion <NUM> has a rib portion 103q extending in the radial direction. The rib portion 103q extends toward the hole portion <NUM> from the outer edge of the main body portion <NUM>, but does not reach the hole portion <NUM>.

Compared to <FIG>, in the reinforcement portion <NUM> in <FIG>, a rib portion 103r reaches the inner peripheral edge of the hole portion <NUM>.

In all of the adhesion promotion devices <NUM> illustrated in <FIG>, the rigidity of the main body portion <NUM> is improved by the reinforcement portion <NUM>, and it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>.

As described above, the adhesion promotion device <NUM> has the main body portion <NUM> formed of the biodegradable sheet having the plurality of through-holes <NUM> and promoting the adhesion of the biological tissues, and the reinforcement portion <NUM> disposed in a portion of the main body portion <NUM> and reinforcing the main body portion <NUM>. According to the adhesion promotion device <NUM> configured in this way, the rigidity of the main body portion <NUM> is improved by the reinforcement portion <NUM>, and it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>. In this manner, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM> during the operation (when the adhesion promotion device <NUM> indwells the body). In addition, in a case where any force is applied after the indwelling, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>. Therefore, it is possible to reduce risk factors of an anastomotic leakage after a surgical operation is performed.

The reinforcement portion <NUM> intersects with the line segment <NUM> extending from the center <NUM> of the virtual circle <NUM> inscribed or circumscribed with the main body portion <NUM> at least at one location. According to this configuration, even in a case where the force F of bending the reinforcement portion <NUM> is applied to an intersection portion between the line segment <NUM> and the reinforcement portion <NUM>, the reinforcement portion <NUM> is less likely to be bent. Therefore, the adhesion promotion device <NUM> can prevent the distortion or the misalignment from occurring against the force F.

The reinforcement portion <NUM> intersects with the line segment <NUM> over the entire periphery of the virtual circle <NUM> in the circumferential direction. According to this configuration, the reinforcement portion <NUM> is less likely to be bent even when the force F is applied along any direction. Therefore, the adhesion promotion device <NUM> can prevent the distortion or the misalignment from occurring against the force F applied along any direction.

The reinforcement portion <NUM> has a shape overlapping in an extending direction of the line segment <NUM>. According to this configuration, even in a case where the reinforcement portion <NUM> has an open shape, it is possible to form the reinforcement portion <NUM> intersecting with the line segment <NUM> over the entire periphery of the virtual circle <NUM> in the circumferential direction. Therefore, the adhesion promotion device <NUM> can prevent the distortion or the misalignment from occurring against the force F applied along any direction.

The main body portion <NUM> further has the hole portion <NUM> formed to have the hole diameter larger than that of the through-hole <NUM>. According to this configuration, it is possible to provide the adhesion promotion device <NUM> having a shape suitable for treatment using the adhesion promotion device <NUM>.

The reinforcement portion <NUM> includes the first reinforcement portion <NUM> located on the outer edge side of the main body portion <NUM> and the second reinforcement portion <NUM> located on the inner peripheral edge side of the hole portion <NUM>. According to this configuration, in the main body portion <NUM>, not only the rigidity of the outer edge side can be improved by the first reinforcement portion <NUM>, but also the rigidity of the inner peripheral edge side of the hole portion <NUM> can be improved by the second reinforcement portion <NUM>. When a medical instrument is inserted into the hole portion <NUM>, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>.

In this case, the second reinforcement portion <NUM> is stronger than the first reinforcement portion <NUM> in reinforcing the biodegradable sheet forming the main body portion <NUM>. According to this configuration, the rigidity of the inner peripheral edge side of the hole portion <NUM> can be further improved. When the medical instrument is inserted into the hole portion <NUM>, it is possible to further prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>.

The outer edge of the main body portion <NUM> has the linear shape or the arc shape. According to this configuration, it is possible to provide the adhesion promotion device <NUM> having a shape suitable for treatment using the adhesion promotion device <NUM>.

The reinforcement portion <NUM> has the linear shape or the arc shape. According to this configuration, the shape of the reinforcement portion <NUM> suitable for the shape of the main body portion <NUM> can be selected, and it is possible to further prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>.

Hitherto, the configuration of the adhesion promotion device <NUM> has been described. However, the specific configuration of the adhesion promotion device <NUM> is not particularly limited as long as the sheet-like main body portion <NUM> having a function of promoting the adhesion of the biological tissues is reinforced by the reinforcement portion <NUM> disposed in a portion of the main body portion <NUM>. As another modification example, for example, the adhesion promotion device <NUM> may have a communication hole exposed on a side surface of the main body portion <NUM>. In addition, the adhesion promotion device <NUM> may have a shape partially widened in a direction in which the through-hole <NUM> formed in the main body portion <NUM> intersects with the thickness direction (upward-downward direction in <FIG>) of the main body portion <NUM>. In addition, the adhesion promotion device <NUM> may have a shape partially narrowed in the direction in which the through-hole <NUM> formed in the main body portion <NUM> intersects with the thickness direction (upward-downward direction in <FIG>) of the main body portion <NUM>.

Next, a treatment method of using the adhesion promotion device will be described.

<FIG> is a flowchart illustrating each procedure of the treatment method of using the adhesion promotion device.

The treatment method includes disposing an adhesion promotion device provided with a sheet-like main body portion for promoting the adhesion of the biological tissues between one joint target site and the other joint target site which serve as a joint object of the biological organ (S11), and joining the one joint target site and the other joint target site in a state where at least a portion of the main body portion of the adhesion promotion device is disposed between the one joint target site and the other joint target site (S12).

The biological organ and the joint target site in the biological organ which are joined by using the treatment method are not particularly limited, and can be optionally selected. However, in the following description, an example will be described in which the treatment method is applied to large intestine anastomosis. In addition, as the adhesion promotion device used in each medical procedure described below, for example, it is possible to select any desired one from the adhesion promotion devices described above, and it is also possible to select other adhesion promotion devices. However, in the following description, as a representative example which can be preferably used for each medical procedure, an example of using a specific adhesion promotion device will be described. In addition, in each medical procedure described below, detailed description of known medical procedures, known medical devices, and medical instruments will be appropriately omitted.

Hereinafter, in the description herein, "disposing the adhesion promotion device between the biological organs" means at least any one of disposing the adhesion promotion device in a state of being in direct or indirect contact with the biological organs, disposing the adhesion promotion device in a state where a spatial gap is formed with the biological organs, and disposing the adhesion promotion device in both the states (for example, disposing the adhesion promotion device in a state where the adhesion promotion device is in contact with one biological organ and the adhesion promotion device is not in contact with the other biological organ). In addition, in the description herein, a "periphery" does not define a strict range (region), and means a predetermined range (region) as long as a treatment purpose (joining the biological organs to each other) can be achieved. In addition, as long as the treatment purpose can be achieved, in the medical procedure described in the respective treatment methods, orders can be appropriately switched therebetween. In addition, in the description herein, "moving the portions relatively closer to each other" means both moving two or more movement objects closer to each other, and moving only one closer to the other one.

<FIG> is a flowchart illustrating a procedure of an embodiment (large intestine anastomosis) of the treatment method, and <FIG> are views for describing the large intestine anastomosis.

In the treatment method according to the present embodiment, the biological organ serving as the joint object is a large intestine cut due to excision of a cancer tumor. Specifically, the biological organs serving as the joint object are a cut mouth side A1 of the large intestine and a cut anal side A2 of the large intestine. In the following description, a joining procedure will be described in which a mouth portion periphery (one joint target site) on the cut mouth side A1 of the large intestine and a portion (the other joint target site) of an intestinal wall on the cut anal side A2 of the large intestine are joined to each other. In addition, in the present embodiment, an example of using the adhesion promotion device <NUM> illustrated in <FIG> will be described.

As illustrated in <FIG>, the treatment method according to the present embodiment includes disposing the adhesion promotion device <NUM> between the mouth portion periphery of the large intestine and the intestinal wall of the large intestine (S101), moving the mouth portion periphery of the large intestine and the intestinal wall of the large intestine relatively closer to each other (S102), pinching the main body portion of the adhesion promotion device <NUM> between the mouth portion periphery of the large intestine and the intestinal wall of the large intestine (S103), joining both of these to each other in a state where the main body portion <NUM> of the adhesion promotion device <NUM> is pinched between the mouth portion periphery of the large intestine and the intestinal wall of the large intestine (S104), and causing the main body portion of the adhesion promotion device to indwell between the mouth portion periphery of the large intestine and the intestinal wall of the large intestine (S105).

Next, the treatment method according to the present embodiment will be described in detail with reference to <FIG>.

As illustrated in <FIG>, an operator such as a doctor (hereinafter, referred to as an operator) inserts a first engagement instrument <NUM> of an anastomosis device <NUM> into the mouth side A1 of the large intestine. The operator disposes a second engagement instrument <NUM> of the anastomosis device <NUM> on the anal side A2 of the large intestine. Before the second engagement instrument <NUM> is disposed on the anal side A2 of the large intestine, the operator forms a through-hole A21 for inserting the second engagement instrument <NUM> of the anastomosis device <NUM> into the anal side A2 of the large intestine. A timing at which the through-hole A21 is formed is not particularly limited as long as the timing is before the second engagement instrument <NUM> is disposed.

For example, as the anastomosis device <NUM>, a known device used for the large intestine anastomosis can be used. As the first engagement instrument <NUM> and the second engagement instrument <NUM> engage with each other, the anastomosis device <NUM> excises the biological tissue disposed between the first engagement instrument <NUM> and the second engagement instrument <NUM>, and sutures a periphery of the excised biological tissue into a circumferential shape by using a stapler. For example, the first engagement instrument <NUM> is an instrument including a cylindrical engagement target portion <NUM>. For example, the second engagement instrument <NUM> is an instrument including an engagement pin <NUM> to engage with and to be inserted into the engagement target portion <NUM> of the first engagement instrument <NUM>.

Next, as illustrated in <FIG>, the operator disposes the adhesion promotion device <NUM> between the mouth side A1 of the large intestine and the anal side A2 of the large intestine. According to the present embodiment, the adhesion promotion device <NUM> (refer to <FIG>) where the hole portion (center hole) <NUM> is formed in the main body portion <NUM> is used. When the operator disposes the adhesion promotion device <NUM>, the operator causes the engagement pin <NUM> included in the second engagement instrument <NUM> to pass through the hole portion <NUM> formed in the main body portion <NUM>. In this case, the operator brings the main body portion <NUM> of the adhesion promotion device <NUM> into contact with the vicinity having the through-hole A21 formed on the anal side A2 of the large intestine. The operator may dispose the adhesion promotion device <NUM> on the mouth side A1 of the large intestine by causing the engagement target portion <NUM> included in the first engagement instrument <NUM> to pass through the hole portion <NUM> formed in the main body portion <NUM>.

Next, as illustrated in <FIG>, the operator engages the first engagement instrument <NUM> and the second engagement instrument <NUM> with each other by moving both of these relatively closer to each other. The operator pinches the mouth portion periphery on the mouth side A1 of the large intestine, the main body portion <NUM> of the adhesion promotion device <NUM>, the periphery of the through-hole A21 formed on the intestinal wall on the anal side A2 of the large intestine between the first engagement instrument <NUM> and the second engagement instrument <NUM>. The operator operates the anastomosis device <NUM>. In this manner, while the operator excises a portion on the mouth side A1 of the large intestine, a portion of the main body portion <NUM> of the adhesion promotion device <NUM>, and a portion on the anal side A2 of the large intestine which are pinched between the first engagement instrument <NUM> and the second engagement instrument <NUM>, the operator joins the peripheries of the excised portions to each other by using a stapler (not illustrated).

Next, as illustrated in <FIG>, the operator removes the anastomosis device <NUM> to the outside of the living body from the anal side A2 of the large intestine via an anus, for example. In addition, the operator causes the adhesion promotion device <NUM> to indwell in a state where a portion of the main body portion <NUM> of the adhesion promotion device <NUM> is pinched between the mouth portion periphery on the mouth side A1 of the large intestine and the intestinal wall on the anal side A2 of the large intestine.

As described above, in the treatment method according to the present embodiment, the mouth portion periphery of the large intestine and the intestinal wall of the large intestine are joined to each other. According to the treatment method, the main body portion <NUM> of the adhesion promotion device <NUM> disposed between the mouth portion periphery on the mouth side A1 of the large intestine and the intestinal wall on the anal side A2 of the large intestine can promote the adhesion between the biological tissue in the periphery on the mouth side A1 of the large intestine and the biological tissue on the intestinal wall on the anal side A2 of the large intestine. Therefore, it is possible to reduce risk factors of an anastomotic leakage after large intestine anastomosis.

According to this treatment method, an easy method is used in such a way that the sheet-like main body portion included in the adhesion promotion device is pinched between one joint target site and the other joint target site. The easy method can reduce the risk factors of the anastomotic leakage after a medical joining procedure (for example, anastomosis of a digestive tract).

In addition, in the adhesion promotion device <NUM> to be used, the rigidity of the main body portion <NUM> is improved by the reinforcement portion <NUM>. Accordingly, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM> during the operation of the operator (when the adhesion promotion device <NUM> indwells the body). In addition, in a case where any force is applied after the indwelling, it is possible to prevent the distortion or the misalignment from occurring in the adhesion promotion device <NUM>. Therefore, it is possible to reduce the risk factors of the anastomotic leakage after a surgical operation is performed.

Claim 1:
An adhesion promotion device (<NUM>) comprising:
a main body portion (<NUM>) formed of a biodegradable sheet having a plurality of through-holes (<NUM>) and is configured to promote adhesion of biological tissues; and
a reinforcement portion (<NUM>) disposed on a portion of the main body portion (<NUM>) and reinforcing the main body portion (<NUM>),
wherein the main body portion (<NUM>) further has a hole portion (<NUM>) formed to have a hole diameter larger than that of each of the plurality of through-holes (<NUM>),
wherein the reinforcement portion (<NUM>) includes a first reinforcement portion (<NUM>, <NUM>) located on an outer edge side of the main body portion (<NUM>) and a second reinforcement portion (<NUM>, <NUM>) located on an inner peripheral edge side of the hole portion (<NUM>),
wherein the second reinforcement portion (<NUM>, <NUM>) has greater strength for reinforcing the biodegradable sheet forming the main body portion (<NUM>) than that of the first reinforcement portion (<NUM>, <NUM>).