Patent Description:
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 joining device (refer to PTL <NUM>) for performing anastomosis on the biological organs by using a stapler has been proposed. In particular, in a case where anastomosis is performed by using the mechanical joining 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.

Document <CIT> discloses an adhesion promotion device according to the preamble of claim <NUM>.

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 joining 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 the present invention, there is provided an adhesion promotion device according to independent claim <NUM>. The dependent claims relate to advantageous embodiments.

According to the adhesion promotion device of the present invention, the adhesion of the biological tissue of the biological organs can be promoted by pinching the main body portion between the biological organs serving as the joint object. In addition, while a medical procedure is performed, an operator uses the holding portion provided in the main body portion to increase the holding force of the main body portion for the biological organs serving as the joint object. In this manner, the main body portion can be prevented from falling out of the biological organs. Therefore, the operator can effectively reduce risk factors of an anastomotic leakage of the biological organs.

In describing the drawings, the same reference numerals will be assigned to the same elements, and repeated description will be omitted. In addition, dimensional ratios in the drawings may be exaggerated for convenience of description, and may be different from actual ratios in some cases.

<FIG> is a perspective view when an adhesion promotion device <NUM> is viewed from a rear surface <NUM> side. <FIG> is a perspective view when the adhesion promotion device <NUM> is viewed from a front surface <NUM> side. <FIG> is an enlarged cross-sectional view illustrating a portion of a cross section taken along line <NUM>-<NUM> in <FIG>. <FIG> is a plan view simply illustrating each of regions 20A and 20B in the adhesion promotion device <NUM>.

As illustrated in <FIG>, the adhesion promotion device <NUM> has a main body portion <NUM> disposed between biological organs serving as a joint object. The main body portion <NUM> has a first region 10A and a second region 10B formed along an outer edge of the first region. The second region 10B includes an adhesion promotion portion <NUM> formed of a biodegradable sheet having a plurality of through-holes <NUM> and promoting adhesion of a biological tissue. The first region 10A includes a holding portion <NUM> having a holding force with respect to the biological organs which is stronger than that of the adhesion promotion portion <NUM>.

As illustrated in <FIG>, the adhesion promotion device <NUM> is applicable to a medical procedure (for example, anastomosis for a digestive tract) in which predetermined biological organs are joined to each other. As will be described later, in describing the present specification, the large intestine anastomosis will be described as an example of the medical procedure of using the adhesion promotion device <NUM>.

As illustrated in <FIG>, the main body portion <NUM> is configured to include a sheet-shaped member.

The main body portion <NUM> has the first region 10A and the second region 10B formed along the outer edge of the first region 10A. The outer edge of the first region 10A is an imaginary line C1 in the drawing.

As illustrated in <FIG>, the first region 10A and the second region 10B of the main body portion <NUM> include the adhesion promotion portion <NUM> formed of the biodegradable sheet having the plurality of through-holes <NUM>.

In addition, as illustrated in <FIG> and <FIG>, the first region 10A further includes the holding portion <NUM> formed on a rear surface <NUM> of the adhesion promotion portion <NUM>, and an insertion portion <NUM> formed of an elastic member and into which a joining device <NUM> for joining the biological organs is inserted.

For example, the joining device <NUM> (medical instrument) for joining the biological organs includes an automatic anastomosis device including a first engagement instrument <NUM> and a second engagement instrument <NUM> (refer to <FIG>). For example, the first engagement instrument <NUM> and the second engagement instrument <NUM> are anvils and trocars. The main body portion <NUM> formed of the biodegradable sheet can be preferably used for a predetermined medical procedure.

In a case where the main body portion <NUM> is used for the medical procedure of using the joining device <NUM>, an operator (operator such as a doctor) sets each of the first engagement instrument <NUM> and the second engagement instrument <NUM> in the biological organs serving as the joint object (refer to <FIG>). Then, the operator sets the main body portion <NUM> in the biological organs serving as the joint object by inserting the first engagement instrument <NUM> into the insertion portion <NUM> of the main body portion <NUM>. Then, the operator causes the first engagement instrument <NUM> and the second engagement instrument <NUM> to engage with each other in a state where the main body portion <NUM> is set in the biological organs serving as the joint object (refer to <FIG>). In this manner, the operator can dispose the main body portion <NUM> between the biological organs serving as the joint object.

In the medical procedure, in the main body portion <NUM>, the holding portion <NUM> provided in the first region 10A of the main body portion <NUM> is at least partially caught on the biological organs serving as the joint object. In this manner, the holding force with respect to the biological organs can be increased. In this manner, the operator can prevent the main body portion <NUM> from falling out of the biological organs due to misalignment of the main body portion <NUM>.

In addition, in a state where the first engagement instrument <NUM> and the second engagement instrument <NUM> engage with each other, the operator causes the joining device <NUM> to puncture and excise a portion of the biological organ pinched by the joining device <NUM> and a portion of the main body portion <NUM>. In addition, the operator causes the joining device <NUM> to excise each configuration member pinched by the joining device <NUM>, and joins peripheries of the excised site at the same time. Then, the joining device <NUM> is removed outward of a living body (refer to <FIG>).

In the medical procedure, the joining device <NUM> punches each configuration member pinched by the joining device <NUM> by using a punching blade (not illustrated) incorporated in the first engagement instrument <NUM> or the second engagement instrument <NUM>. Therefore, as illustrated in <FIG> and <FIG>, a region E2 where the biological organ joined by the joining device <NUM> is punched is located inward of a region E1 where the first engagement instrument <NUM> and the second engagement instrument <NUM> face and overlap each other across the main body portion <NUM>.

In addition, as illustrated in <FIG> and <FIG>, the first region 10A of the main body portion <NUM> is located inward of the region E1 where the first engagement instrument <NUM> and the second engagement instrument <NUM> face and overlap each other across the main body portion <NUM>. According to this configuration, in a state where the operator pinches the main body portion <NUM> between the first engagement instrument <NUM> and the second engagement instrument <NUM>, when the main body portion <NUM> pinched by the joining device <NUM> is punched, the operator can remove most of the holding portion <NUM>. In addition, when the operator removes the joining device <NUM> outward of the living body, the operator can remove most of the holding portion <NUM> provided in the first region 10A of the main body portion <NUM> outward of the living body. For example, in a case where the holding portion <NUM> is formed of a biodegradable material, in the above-described medical procedure, at least a portion of the holding portion <NUM> may indwell the living body after the main body portion <NUM> is punched by the joining device <NUM>. In a case where the holding portion <NUM> is formed of the biodegradable material, the holding portion <NUM> is degraded and absorbed inside the living body.

It is preferable that the first region 10A of the main body portion <NUM> is formed of a biodegradable sheet. However, a material thereof is not particularly limited as long as the first region 10A can be disposed in the biological organ and further has the holding portion. Most of the first region 10A of the main body portion <NUM> is punched by the joining device <NUM>. Accordingly, as illustrated in <FIG>, the first region 10A may not be formed by the adhesion promotion portion <NUM>.

As illustrated in <FIG> and <FIG>, it is preferable that the first region 10A of the main body portion <NUM> is located inward of the region E2 where the biological organ joined by the joining device <NUM> is punched. According to this configuration, when the joining device <NUM> is removed outward of the living body, all of the holding portion <NUM> provided in the first region 10A of the main body portion <NUM> can be removed outward of the living body. In this manner, even in a case where the holding portion <NUM> is formed of a non-biodegradable material, it is possible to reduce a possibility that foreign substances may indwell the body.

On the other hand, as illustrated in <FIG>, only the adhesion promotion portion <NUM> is provided in the second region 10B of the main body portion <NUM>. In the above-described medical procedure, in a state of being pinched between the first engagement instrument <NUM> and the second engagement instrument <NUM>, the second region 10B of the main body portion <NUM> indwells the living body after being joined by the joining device <NUM> and the main body portion <NUM> is punched by the joining device <NUM>. Therefore, the main body portion <NUM> can reliably fulfil a function of promoting adhesion with respect to the biological organs serving as the joint object by using the adhesion promotion portion <NUM> provided in the second region 10B of the main body portion <NUM>.

As illustrated in <FIG>, each of the through-holes <NUM> formed in the adhesion promotion portion <NUM> is regularly and periodically provided in a surface direction of the adhesion promotion portion <NUM>. However, each of the through-hole <NUM> may be randomly provided in each portion in the surface direction of the adhesion promotion portion <NUM>.

As illustrated in <FIG>, each of the through-holes <NUM> extends substantially perpendicular between the front surface <NUM> and the rear surface <NUM> along a thickness direction (upward-downward direction in <FIG>) of the adhesion promotion portion <NUM>. Each of the through-holes <NUM> may be bent or curved in a zigzag manner between the front surface <NUM> and the rear surface <NUM>, in a cross section taken along the thickness direction of the adhesion promotion portion <NUM>.

Each of the through-holes <NUM> has a substantially circular planar shape (shape when the front surface <NUM> of the adhesion promotion portion <NUM> or the rear surface <NUM> of the adhesion promotion portion <NUM> is viewed in a plan view). However, the planar shape of each of the through-holes <NUM> is not particularly limited, and may be an elliptical shape or a polygonal shape (rectangular shape or triangular shape), for example. In addition, each of the through-holes <NUM> may have a different planar shape or cross-sectional shape.

The adhesion promotion portion <NUM> has a substantially circular planar shape. However, the planar shape of the adhesion promotion portion <NUM> is not particularly limited, and may be an elliptical shape or a polygonal shape (rectangular shape or triangular shape), for example.

A thickness (dimension T illustrated in <FIG>) of the adhesion promotion portion <NUM> is not particularly limited. However, the thickness is preferably <NUM> to <NUM>, and is more preferably <NUM> to <NUM>. In a case where the thickness of the adhesion promotion portion <NUM> is <NUM> or larger (particularly in a case where the thickness is <NUM> or larger), the adhesion promotion portion <NUM> can be provided with strength to such an extent that the adhesion promotion portion <NUM> is not damaged when the adhesion promotion device <NUM> is handled. On the other hand, in a case where the thickness of the adhesion promotion portion <NUM> is <NUM> or smaller (particularly when the thickness is <NUM> or smaller), the adhesion promotion portion <NUM> can be provided with sufficient flexibility to follow the biological tissue after the adhesion promotion portion <NUM> closely adheres to the biological tissue to which the adhesion promotion portion <NUM> is applied.

According to the claimed invention, the adhesion promotion portion <NUM> has a ratio value of hole diameter D (distance D illustrated in <FIG>) of the through-hole <NUM> with respect to a pitch P (distance P illustrated in <FIG> and a distance between the through-holes <NUM> adjacent to each other) of the through-holes <NUM> is <NUM> or greater and smaller than <NUM>. In a case where the planar shape of the through-hole <NUM> is a perfect circle, 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 planar shape of the through-hole <NUM> is not the perfect circle, the diameter of the perfect circle (diameter corresponding to a 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 defined as the hole diameter D of the through-hole <NUM>.

The adhesion promotion portion <NUM> has the plurality of through-holes <NUM>. Accordingly, a plurality of values exist in the hole diameter D corresponding to each of the through-holes <NUM>. Therefore, in the present embodiment, in calculating the above-described ratio value, an arithmetic mean value of two or more values of the hole diameter D corresponding to each of the plurality of the 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> is defined by a shortest distance between the opening portions of the two through-holes <NUM>. However, with regard to the value of the pitch P, a plurality of values exist in the pitch P corresponding to a combination of the through-holes <NUM> adjacent to each other. Therefore, in the present embodiment, in calculating the above-described ratio value, the arithmetic mean 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 the representative value of the pitch P.

The pitch P, the hole diameter D, and the ratio of the hole diameter D with respect to the pitch P of the through-hole <NUM> are examples, and the configuration is not limited thereto.

The adhesion promotion portion <NUM> can be formed of a biodegradable material. A material of forming the adhesion promotion portion <NUM> is not particularly limited, and includes a biodegradable resin, for example. For example, as the biodegradable resin, it is possible to use known degradable (co)polymers disclosed in <CIT>, <CIT>, Pamphlet of International Publication No. <CIT>, or <CIT>. Specifically, the biodegradable resin includes (<NUM>) a polymer selected from a group consisting of aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose, and (<NUM>) a copolymer formed of one or more monomers forming (<NUM>) described above. That is, it is preferable that the biodegradable sheet includes at least one type of the biodegradable resin selected from the group consisting of the polymer selected from the group consisting of aliphatic polyester, polyester, polyacid anhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate ester, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose, and the copolymer formed of one or more monomers forming the polymer.

A method for manufacturing the adhesion promotion portion <NUM> is not particularly limited. For example, the method includes a method for preparing a fiber formed of the above-described biodegradable resin and manufacturing a mesh-shaped sheet by using the fiber. The method for preparing the fiber formed of the biodegradable resin is not particularly limited. For example, the method includes an electrospinning method (electrospinning method and electrostatic spinning method) and a melt blow method. For the adhesion promotion portion <NUM>, only one of the above-described methods may be selected and used, or two or more of the above-described methods may be selected and appropriately combined with each other. As still another example of the method for manufacturing the adhesion promotion portion <NUM>, the biodegradable sheet according to the present invention may be manufactured by spinning the fiber formed of the above-described biodegradable resin in accordance with a usual method in the related art and knitting the obtained fiber into a mesh shape.

The adhesion promotion portion <NUM> induces a biological reaction by a forming material such as the biodegradable resin forming the adhesion promotion portion <NUM>. The adhesion promotion portion <NUM> induces expression of a biological component such as fibrin by the action. The biological component induced in this way can promote the adhesion by being accumulated to penetrate the through-hole <NUM> of the adhesion promotion portion <NUM>. Therefore, the adhesion promotion portion <NUM> formed in the main body portion <NUM> of the adhesion promotion device <NUM> is disposed between the biological organs serving as the joint object. In this manner, the adhesion is promoted by the above-described mechanism.

A material of the adhesion promotion portion <NUM> may not be biodegradable as long as the adhesion can be promoted. In addition, the adhesion promotion portion <NUM> may not have the through-hole <NUM> regardless of the material, as long as the adhesion can be promoted.

As illustrated in <FIG>, the holding portion <NUM> is provided in the first region 10A of the main body portion <NUM>. The adhesion promotion portion <NUM> is provided in the first region 10A of the main body portion <NUM>, and the holding portion <NUM> is provided in the rear surface <NUM> of the adhesion promotion portion <NUM>. In addition, the holding portion <NUM> has a plurality of projection portions <NUM>. The plurality of the projection portion <NUM> applies a holding force with respect to the biological organ to the main body portion <NUM> by disposing the main body portion <NUM> in the biological organ serving as the joint object.

As illustrated in <FIG>, the plurality of the projection portion <NUM> are conical projections. The plurality of the projection portion <NUM> utilizes a conical shape of each of the projection portions <NUM>. In this manner, sliding resistance (friction resistance) can be at least partially generated for the biological organ serving as the joint object. According to this configuration, the main body portion <NUM> can increase the holding force with respect to the biological organ by the plurality of projection portions <NUM>. In this manner, an operator can prevent the adhesion promotion device <NUM> from falling out of the biological organ while a medical procedure is performed.

A distal end of the plurality of conical projection portions <NUM> can partially penetrate a front surface tissue of the biological organ serving as the joint object. Therefore, the plurality of the projection portion <NUM> can more reliably generate the sliding resistance with respect to the biological organ serving as the joint object.

A cross-sectional shape of each of the projection portions <NUM> is not particularly limited as long as the shape is a projection shape. For example, the projection portion <NUM> can be formed in a polygonal shape such as a triangular shape and a trapezoidal shape, a dome shape, or a branch shape in which the shapes are combined with each other.

In addition, a size of each of the projection portions <NUM> is not particularly limited. As illustrated in <FIG>, the size of each of the projection portions <NUM> may be constant, or may be irregular.

As illustrated in <FIG>, the plurality of projection portions <NUM> are regularly provided with respect to a center position of the main body portion <NUM> in the surface direction of the main body portion <NUM>. According to this configuration, the holding portion <NUM> provided in the first region 10A of the main body portion <NUM> more equally applies the holding force with respect to the biological organ in the surface direction of the main body portion <NUM>.

Each disposition of the projection portions <NUM> is not particularly limited. For example, each of the projection portions <NUM> may be irregularly provided, instead of being regularly provided with respect to the center position of the main body portion <NUM> in the surface direction of the main body portion <NUM>.

In addition, for example, each of the projection portions <NUM> can be formed of the biodegradable resin, a thermoplastic elastomer, a thermoplastic resin such as nylon and PET, or metal such as a SUS wire, a copper wire, a titanium wire, and a nitinol wire. The material of each of the projection portions <NUM> is not particularly limited as long as each of the projection portions <NUM> can be caught on the biological organ in a state where the main body portion <NUM> is disposed in the biological organ serving as the joint object, and the holding force of the main body portion <NUM> can be increased for the biological organ.

In addition, the method of preparing the projection portion <NUM> is not particularly limited. The holding portion <NUM> configured to include the projection portion <NUM> may be integrally formed on the outer surface of the main body portion <NUM>, or may be molded separately from the main body portion <NUM> to be connected to the main body portion <NUM> by covering the outer surface of the main body portion <NUM>. In this manner, a preparing method suitable for the forming material of the holding portion <NUM> can be adopted.

In addition, an example has been described in which the number of the projection portions <NUM> is two or more. However, the number of the projection portions <NUM> may be one.

In addition, the projection portion <NUM> may have a hook shape for preventing slippage.

As illustrated in <FIG>, the insertion portion <NUM> is provided at a center position of the first region 10A of the main body portion <NUM>. In addition, an insertion hole <NUM> into which the joining device <NUM> is inserted is provided at the center position of the insertion portion <NUM>.

As illustrated in <FIG>, the insertion portion <NUM> has a substantially circular planar shape. However, the planar shape of the insertion portion <NUM> is not particularly limited, and may be an elliptical shape or a polygonal shape (rectangular shape or triangular shape), for example. In addition, the insertion portion <NUM> may be disposed at any position in the first region 10A of the main body portion <NUM>.

As illustrated in <FIG>, the insertion portion <NUM> includes the insertion hole <NUM> penetrating the main body portion <NUM> in the thickness direction. The insertion portion <NUM> is formed of an elastic material, and can be at least partially deformed along a direction in which the joining device <NUM> is inserted into the insertion hole <NUM> (refer to <FIG>). According to this configuration, the insertion portion <NUM> can at least partially generate the sliding resistance in the joining device <NUM>. Therefore, the main body portion <NUM> can increase the holding force with respect to the joining device <NUM> inserted into the insertion hole <NUM> by the insertion portion <NUM>. Therefore, the operator can prevent the adhesion promotion device <NUM> from falling out of the joining device <NUM> while the medical procedure is performed.

As illustrated in <FIG>, the insertion hole <NUM> has a cross-cut shape. An imaginary hole diameter d1 connecting outer edges of the insertion hole <NUM> can be formed to be <NUM> to <NUM>, for example. The planar shape of the insertion hole <NUM> is not limited to the cross-cut shape. The planar shape of the insertion hole <NUM> is not particularly limited as long as the planar shape is substantially the same as that of the joining device <NUM> inserted into the insertion hole <NUM>, or a shape that can at least partially generate the sliding resistance with respect to the joining device <NUM> inserted into the insertion hole <NUM> and can increase the holding force of the main body portion <NUM> for the joining device <NUM>. In addition, the insertion hole <NUM> may be disposed at any position in the insertion portion <NUM>.

For example, the insertion portion <NUM> can be formed of rubber or silicone elastomer. A material of the insertion portion <NUM> is not particularly limited as long as the insertion portion <NUM> can at least partially generate the sliding resistance with respect to the joining device <NUM>, when the operator sets the main body portion <NUM> in the biological organ serving as the joint object by inserting the joining device <NUM> into the insertion hole <NUM>.

In addition, a method of preparing the insertion portion <NUM> is not particularly limited. The insertion portion <NUM> may be formed integrally with the outer surface of the main body portion <NUM>, or may be molded separately from the main body portion <NUM> to be connected to the outer surface of the main body portion <NUM>. In this manner, a preparing method suitable for the forming material of the insertion portion <NUM> can be adopted.

In addition, the method of preparing the insertion hole <NUM> is not particularly limited. The insertion hole <NUM> may be prepared in advance when the insertion portion <NUM> is prepared, or may be prepared by the operator while the medical procedure is performed.

In addition, without being limited to the joining device <NUM> that joins the biological organs, a medical instrument that can be inserted into the insertion hole <NUM> is not particularly limited.

As described above, the adhesion promotion device <NUM> according to the present embodiment has the main body portion <NUM> disposed between the biological organs serving as the joint object. The main body portion <NUM> has the first region 10A and the second region 10B formed along the outer edge of the first region. The second region 10B includes the adhesion promotion portion <NUM> that promotes the adhesion of the biological tissue. The first region 10A includes the holding portion <NUM> having the holding force with respect to the biological organ which is stronger than that of the adhesion promotion portion <NUM>.

According to the adhesion promotion device <NUM> as described above, the holding portion <NUM> provided in the first region 10A of the main body portion <NUM> can at least partially generate the sliding resistance with respect to the biological organ serving as the joint object. Therefore, the main body portion <NUM> can increase the holding force with respect to the biological organ serving as the joint object by the holding portion <NUM>. Therefore, the operator can prevent the main body portion <NUM> from falling out of the biological organ while the medical procedure is performed, and can effectively reduce risk factors of an anastomotic leakage of the biological organ. In addition, the adhesion promotion portion <NUM> provided in the second region 10B of the main body portion <NUM> can promote the adhesion of the biological organs by accumulating the biological component of the biological organ serving as the joint object in the through-hole <NUM>.

The holding portion <NUM> is integrally formed at a portion of the outer surface of the main body portion <NUM>. Alternatively, the holding portion <NUM> is formed separately from the main body portion <NUM>, and is connected to a portion of the outer surface of the main body portion <NUM> while covering the portion of the outer surface of the main body portion <NUM>. According to this configuration, a preparing method suitable for the forming material of the holding portion <NUM> can be adopted.

The holding portion <NUM> includes at least one of the projection portions <NUM>. According to this configuration, the distal end of the projection portion <NUM> can partially penetrate a front surface tissue of the biological organ serving as the joint object. Therefore, the holding portion <NUM> can more reliably generate the sliding resistance with respect to the biological organ serving as the joint object. Therefore, while the medical procedure is performed, the operator can prevent the adhesion promotion device <NUM> from falling out of the biological organ, and can effectively reduce the risk factors of the anastomotic leakage of the biological organ.

The main body portion <NUM> further has the insertion portion <NUM> formed of the elastic member, and the insertion portion <NUM> further has the insertion hole <NUM> into which the joining device <NUM> is inserted. According to this configuration, the insertion portion <NUM> can be at least partially deformed along the direction in which the joining device <NUM> is inserted into the insertion hole <NUM>. In this manner, the insertion portion <NUM> can at least partially generate the sliding resistance with respect to the joining device <NUM> inserted into the insertion hole <NUM>. Therefore, the main body portion <NUM> can increase the holding force with respect to the inserted joining device <NUM> by the insertion portion <NUM>. Therefore, while the medical procedure is performed, the operator can prevent the adhesion promotion device <NUM> from falling out of the joining device <NUM>, and can effectively reduce the risk factors of the anastomotic leakage of the biological organ.

The main body portion <NUM> is disposed in one joint target site of the biological organ serving as the joint object, and the second region 10B is joined to the biological tissue by the medical instrument including the first engagement instrument <NUM> disposed in one joint target site of the biological organ, and the second engagement instrument <NUM> disposed in the other joint site of the biological organ and facing the first engagement instrument <NUM>. In addition, when the main body portion <NUM> is joined to the biological tissue by the first engagement instrument <NUM> and the second engagement instrument <NUM>, the first region 10A is located inward of the region E1 where the first engagement instrument <NUM> and the second engagement instrument <NUM> face and overlap each other across the main body portion <NUM>. According to this configuration, while the joining device <NUM> punches and excises a portion of the biological organ pinched by the joint portion of the joining device <NUM> and a portion of the main body portion <NUM>, the joining device <NUM> joins peripheries of the excised site. When the joining device <NUM> is removed outward of the living body, most of the holding portion <NUM> can be removed outward of the living body. Therefore, even when the holding portion <NUM> is formed of a non-biodegradable material, it is possible to reduce a possibility that foreign substances may indwell the body.

Hitherto, the adhesion promotion device <NUM> has been described with reference to the embodiment. However, the present invention is not limited to the description of the above-described embodiment, and various modifications can be made within the scope not departing from the concept. In the following description, modification examples of the holding portion <NUM> will be described. In describing the modification examples, configurations and contents which are described above in the adhesion promotion device <NUM> will be appropriately omitted in the description. In addition, the contents not particularly described in the modification examples can be regarded as the same as those in the above-described embodiment.

<FIG> is a perspective view illustrating a modification example of the holding portion in an adhesion promotion device 100A. <FIG> is a cross-sectional view illustrating the modification example of the holding portion in the adhesion promotion device 100A.

As illustrated in <FIG>, the adhesion promotion device 100A has the main body portion <NUM> disposed between the biological organs serving as the joint object. The main body portion <NUM> has the first region 10A and the second region 10B formed along the outer edge of the first region. The second region 10B includes the adhesion promotion portion <NUM> formed of a biodegradable sheet having the plurality of through-holes <NUM> and promoting the adhesion of the biological tissue. The first region 10A has a holding portion 30A having the holding force with respect to the biological organ which is stronger than that of the adhesion promotion portion <NUM>, and the insertion portion <NUM> that can increase the holding force of the main body portion <NUM> for the joining device <NUM>. The insertion portion <NUM> includes the insertion hole <NUM> into which the joining device <NUM> is inserted.

As illustrated in <FIG>, the holding portion 30A has a friction portion <NUM> disposed in the biological organ serving as the joint object so that the holding force with respect to the biological organ is applied to the main body portion <NUM>.

For example, the friction portion <NUM> can be formed of a coating agent such as a resin layer to which a particulate substance is added, and can generate the sliding resistance with respect to the biological organ serving as the joint object. Therefore, while the medical procedure is performed, the operator can prevent the adhesion promotion device <NUM> from falling out of the biological organ, and can effectively reduce the risk factors of the anastomotic leakage of the biological organ.

A material of the friction portion <NUM> is not particularly limited. The friction portion <NUM> can be formed of a material that can at least partially generate the sliding resistance with respect to the front surface tissue of the biological organ serving as the joint object, and can increase the holding force of the main body portion <NUM> for the biological organ. In addition, a cross-sectional shape of the friction portion <NUM> is not limited to a configuration including a projection shape, and is not particularly limited.

In addition, disposition of the friction portion <NUM> is not particularly limited. For example, as illustrated in <FIG>, the friction portion <NUM> may be entirely provided in the first region 10A of the main body portion <NUM>, or may be partially provided.

In addition, a method of preparing the friction portion <NUM> is not particularly limited. The friction portion <NUM> may be integrally formed on the outer surface of the main body portion <NUM>, or may be molded separately from the main body portion <NUM> to be connected to the main body portion <NUM> by covering the outer surface of the main body portion <NUM>. In this manner, a preparing method suitable for the forming material of the friction portion <NUM> can be adopted. In addition, the thickness of the friction portion <NUM> is not particularly limited.

Hitherto, an example of the configuration of the adhesion promotion device has been described. However, a specific configuration thereof is not limited as long as the main body portion <NUM> of the adhesion promotion device <NUM> according to the present invention has the holding portion <NUM>. For example, the holding portion <NUM> may be configured so that the projection portion <NUM> and the friction portion <NUM> are appropriately combined with each other. In addition, the main body portion <NUM> may have the hole portion without having the insertion portion <NUM>. The hole portion may be prepared in advance in the main body portion <NUM>, or may be prepared by the operator while the medical procedure is performed. The operator can select various modifications of the main body portion <NUM> in accordance with a progress of the medical procedure.

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 the adhesion promotion device including the sheet-shaped main body portion that promotes the adhesion of the biological tissue between one joint target sites and the other joint target site of the joint object of the biological organ (S11), and joining one joint target site and the other joint target site to each other in a state where at least a portion of the main body portion of the adhesion promotion device is disposed between one joint target site and the other joint target site (S12).

The biological organs joined by using the treatment method and the joint target site in the biological organs are not particularly limited, and can be selected in any desired manner. However, in the following description, large intestine anastomosis will be described as an example. In addition, as the adhesion promotion device used in each medical procedure described below, for example, any desired device can be selected from the above-described adhesion promotion devices. However, in the following description, as a representative example that can be preferably used for each medical procedure, an application example of the adhesion promotion device <NUM> illustrated in <FIG> will be described. In addition, in each medical procedure described below, detailed description of a known medical procedure or a known joining device will be appropriately omitted.

Hereinafter, in the description in the present specification, "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 between the adhesion promotion device and 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 in the present specification, 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 each treatment method, orders can be appropriately switched thereamong. In addition, in the description in the present specification, "moving the portions to be relatively closer to each other" means both moving two or more objects to be closer to each other, and moving only one to be closer to the other one.

<FIG> is a flowchart illustrating a procedure of an embodiment of the treatment method (large intestine anastomosis), 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 mouth side A1 of the cut large intestine and an anal side A2 of the cut large intestine. In the following description, a procedure will be described in which a mouth portion periphery (one joint target site) on the mouth side A1 of the cut large intestine and a portion (other joint target site) of an intestinal wall on the anal side A2 of the cut large intestine are joined to each other.

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 to be relatively closer to each other (S102), pinching the main body portion <NUM> 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 the mouth portion periphery of the large intestine and the intestinal wall of the large intestine to each other in a state where the main body portion <NUM> of the adhesion promotion device <NUM> is pinched therebetween (S104), and causing the main body portion <NUM> of the adhesion promotion device <NUM> 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>, the operator inserts the first engagement instrument <NUM> of the joining device <NUM> into the mouth side A1 of the large intestine. The operator disposes the second engagement instrument <NUM> of the joining 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 joining 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 joining 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 joining 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>.

The operator inserts the engagement target portion <NUM> of the first engagement instrument <NUM> into the mouth side A1 of the large intestine, and performs purse-string suture in a projecting state of the engagement target portion <NUM>, thereby forming a suture portion A11. An outer surface of the suture portion A11 has a shape partially projecting to a projection side due to the suture.

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. The operator disposes the adhesion promotion device <NUM> so that the plurality of projection portions <NUM> formed on the rear surface <NUM> of the adhesion promotion portion <NUM> in the main body portion <NUM> come into contact with the suture portion A11 on the mouth side A1 of the large intestine. Then, the operator causes the engagement target portion <NUM> included in the first engagement instrument <NUM> to pass through the insertion hole <NUM> formed in the insertion portion <NUM> of the main body portion <NUM>. In this manner, the insertion portion <NUM> can at least partially generate the sliding resistance with respect to the joining device <NUM> inserted into the insertion hole <NUM>. Therefore, the main body portion <NUM> can increase the holding force with respect to the joining device <NUM> inserted into the insertion hole <NUM> by the insertion portion <NUM>. Therefore, while the medical procedure is performed, the operator can prevent the adhesion promotion device <NUM> from falling out of the engagement target portion <NUM>.

Next, as illustrated in <FIG>, the operator brings the plurality of projection portions <NUM> formed in the main body portion <NUM> into contact with the suture portion A11 on the mouth side A1 of the large intestine. The distal end of the plurality of projection portions <NUM> is disposed so that the distal end can partially penetrate the front surface tissue of the suture portion A11. In this manner, the plurality of projection portions <NUM> can at least partially generate the sliding resistance with respect to the front surface tissue of the suture portion A11. Therefore, the main body portion <NUM> can increase the holding force with respect to the biological organ serving as the joint object by the plurality of projection portions <NUM>. Therefore, while the medical procedure is performed, the operator can prevent the adhesion promotion device <NUM> from falling out of the suture portion A11, and can effectively reduce the risk factors of the anastomotic leakage of the biological organ. The operator may dispose the adhesion promotion device <NUM> on the anal side A2 of the large intestine by causing the engagement pin <NUM> included in the second engagement instrument <NUM> to pass through the insertion hole <NUM> formed in the insertion portion <NUM> of the main body portion <NUM>.

Next, while the operator maintains a state where the main body portion <NUM> is held with respect to the mouth side A1 of the large intestine by the holding portion <NUM>, the operator engages the first engagement instrument <NUM> and the second engagement instrument <NUM> with each other by moving the first engagement instrument <NUM> and the second engagement instrument <NUM> to be relatively closer to each other as illustrated in <FIG>. 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>, and 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 causes the joining device <NUM> to excise 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 pinched between the first engagement instrument <NUM> and the second engagement instrument <NUM>. In addition, at the same time, the operator operates the joining device <NUM> to join the peripheries of the excised site by using a stapler (not illustrated).

Next, as illustrated in <FIG>, the operator removes the joining device <NUM> outward of the living body from the anal side A2 of the large intestine via an anus, for example. In this case, the operator causes the joining device <NUM> to excise most of the plurality of projection portions <NUM> of the main body portion <NUM> disposed in the region E2 located inward of the region E1 where the first engagement instrument <NUM> and the second engagement instrument <NUM> face and overlap each other across the main body portion <NUM>, and where the biological organs joined by the joining device <NUM> are punched, and can remove most of the plurality of projection portions <NUM> outward of the living body together with the joining device <NUM>. On the other hand, the adhesion promotion portion <NUM> of the main body portion <NUM> disposed outward of the region E2 where the biological organs joined by the joining device <NUM> are punched indwells the living body in a state of being 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. Therefore, the adhesion promotion device <NUM> can reliably fulfil a function of promoting the adhesion with respect to 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 which serve as the joint objects by using the adhesion promotion portion <NUM> of the main body portion <NUM>.

According to this treatment method, a simple method of pinching the sheet-shaped main body portion included in the adhesion promotion device between one joint target site and the other joint target site is used. In this manner, it is possible to reduce the risk factors of the anastomotic leakage after a medical procedure for joining (for example, anastomosis for a digestive tract).

In addition, the adhesion promotion device <NUM> when in use increases the holding force of the main body portion <NUM> with respect to the biological organ serving as the joint object by the holding portion <NUM>. Accordingly, when the operator operates the adhesion promotion device <NUM> (when the adhesion promotion device <NUM> indwells the body), the operator can prevent the adhesion promotion device <NUM> from falling out of the biological organ. In addition, the adhesion promotion device <NUM> increases the holding force of the main body portion <NUM> with respect to the joining device <NUM> by the insertion portion <NUM>. Accordingly, when the operator operates the adhesion promotion device <NUM> (when the adhesion promotion device <NUM> indwells the body), the operator can prevent the adhesion promotion device <NUM> from falling out of the joining device <NUM>. Therefore, it is possible to reduce the risk factors of the anastomotic leakage after surgery.

Claim 1:
An adhesion promotion device (<NUM>, 100A) comprising:
a main body portion (<NUM>) configured to be disposed between biological organs,
wherein the main body portion (<NUM>) has a first region (10A) and a second region (10B) formed along an outer edge of the first region (10A),
the second region (10B) includes an adhesion promotion portion (<NUM>) that promotes adhesion of a biological tissue, and
the first region (10A) includes a holding portion (<NUM>, 30A) having a holding force with respect to the biological organs which is stronger than that of the adhesion promotion portion (<NUM>),
characterized in that
said main body portion (<NUM>) is configured to be disposed between biological organs which are anastomosed (<NUM>),
said holding portion is integrally formed at a portion of an outer surface of the main body portion,
said adhesion promotion portion has a plurality of through-holes (<NUM>); and a ratio value of hole diameter D of the through-hole <NUM> with respect to a pitch P of the through-holes <NUM> is <NUM> or greater and smaller than <NUM>.