Bioorgan closure devices

Abstract

To provide a biological organ closing device capable of closing a biological organ without executing purse string suture.SOLUTION: A biological organ closing device 100 comprises: a deformation part 10 which is expandable and contractible and forms a ring shape at least in an expanded state; and a puncture part 20 which is provided on the outer surface of the deformation part to puncture a biological organ Bg therewith. The deformation part can be integrated with the biological organ with the biological organ punctured with the puncture part, and contracts so as to close the biological organ from a state where the biological organ is punctured with the puncture part.SELECTED DRAWING: Figure 14

Description

[Technical Field]

[0001] The present invention relates to a biological organ closure device. [Background technology]

[0002] In the medical field, surgical procedures for joining biological organs (e.g., anastomosis of the digestive tract) are known. For example, anastomosis is performed when a tumor such as cancer is present, the tumor site is dissected from the surrounding area and removed from the body, and the tumor is then inserted into the body and anastomosed.

[0003] In the above-mentioned anastomosis procedure, when removing the tumor-containing region from the body, the organ may be closed at a predetermined longitudinal location, then dissected away from the surrounding tissue, and then removed. For example, in transanal total mesorectal excision (TaTME), the intestinal stump on the anal side may be closed using a procedure called a purse string suture, similar to a purse string suture. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 2021-507294 Summary of the Invention [Problem to be solved by the invention]

[0005] The inventors believe that the above-mentioned Purse String Suture operation is difficult for doctors to master, making it difficult to perform the above-mentioned TaTME, which is one type of anastomosis, and are therefore actively studying alternative methods to the Purse String Suture. Such alternative methods to the Purse String Suture are not limited to closure of a specific site in the rectum, as in TaTME, but may also be applicable to procedures for closure of other biological organs, such as biological lumens.

[0006] The present invention has been made in view of the above problems, and has an object to provide a device that can close a biological organ in a simple manner. [Means for solving the problem]

[0007] The above object can be achieved by the following (1) to (7) which are one aspect of the present invention. (1) A deformable portion that is expandable and contractible and forms a ring shape at least when expanded; a puncture portion provided on an outer surface of the deformable portion and capable of puncturing a biological organ, The deforming portion can be integrated with the biological organ when the puncturing portion is inserted into the biological organ, and contracts to close the biological organ from the state in which the puncturing portion is inserted into the biological organ. (2) A biological organ closure device as described in (1) that has a balloon member that can be expanded and contracted by supplying and discharging fluid, can be placed inside the deformation portion, is constructed separately from the deformation portion, and can expand the deformation portion by expanding while placed inside the deformation portion. (3) a plurality of first elongated members provided in the deformation portion in a circumferential direction of the deformation portion; a moving member that is movable along the longitudinal direction of the plurality of first elongated members and has insertion holes through which the plurality of first elongated members can be inserted, The moving member is capable of approaching the deformation portion along the longitudinal direction, thereby pulling the first elongate member near the deformation portion radially inward and contracting the deformation portion, as described in (1) or (2). (4) A second elongated member is disposed inside the deformation portion along the circumferential direction of the deformation portion and is exposed to the outside at at least two locations from the inside, A biological organ closure device as described in (1) or (2), wherein the deformation portion can be contracted by pulling the second elongated member so that the exposed length of the second elongated member exposed from the inside to the outside of the deformation portion increases. (5) The biological organ closure device according to any one of (1) to (4), wherein the puncture section has a protruding section that can puncture the biological organ and protrudes outward in a direction intersecting the insertion direction. (6) The biological organ closure device according to any one of (1) to (5), wherein the deformable portion includes an elastic member provided on the outer surface. (7) a shaft; a plurality of frame members connected to a base point of the shaft so as to be able to change the angle formed with the shaft; a moving member provided on the shaft so as to be movable in the longitudinal direction of the shaft; a connecting member that connects the moving member and the frame member, The frame member can be changed between an expanded state and a contracted state by moving the movable member in the longitudinal direction of the shaft, When the frame member is in an expanded state, a tip of the frame member can puncture the inside of a biological organ, A biological organ closure device that can close a portion of the biological organ by contracting the frame member when the tip of the frame member is punctured inside the biological organ in the expanded state. [Effects of the Invention]

[0008] The biological organ closure device described above makes it possible to close a biological organ in a simple manner. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is a schematic diagram showing a biological organ closure device according to a first embodiment of the present invention. [Figure 2] 2 is a schematic diagram showing an indwelling section including a deforming section, a puncturing section, and a contracting section that constitute the biological organ closure device of FIG. 1. FIG. [Figure 3] FIG. 3 is a view of the indwelling section in FIG. 2 as seen from the longitudinal direction. [Figure 4] 2 is a diagram showing a state in which a deformation portion is expanded by a balloon member of the expansion portion shown in FIG. 1. FIG. [Figure 5] 3 is a diagram showing a state in which a deformation section is contracted by a contraction section shown in FIG. 2. FIG. [Figure 6] 2 is a schematic view showing a stapler used in an anastomosis operation using the biological organ closure device shown in FIG. 1. FIG. [Figure 7] 7 is a diagram showing the tip of a first engaging device and a second engaging device of the stapler shown in FIG. 6. FIG. [Figure 8] 1 is a flowchart illustrating a procedure for closing a living organ using a living organ closure device. [Figure 9] 10A and 10B show the biological organ closure device delivered to the vicinity of a target site in a biological organ. [Figure 10] FIG. 10 is a longitudinal view of the living organ in the state shown in FIG. 9. [Figure 11] 10 is a diagram showing a state in which the deformation section is expanded by the balloon member of the expansion section from the state shown in FIG. 9. FIG. [Figure 12] FIG. 12 is a longitudinal view of the living organ in the state shown in FIG. [Figure 13] 12 is a diagram showing a state in which a delivery device constituting the biological organ closing device has been removed from the state shown in FIG. 11. FIG. [Figure 14] 14 is a diagram showing a state in which the deformation section is contracted by moving a moving member associated with the contraction section from the state shown in FIG. 13. FIG. [Figure 15] 15 is a diagram illustrating a procedure for removing the part to be excised from the body from the state shown in FIG. 14. FIG. [Figure 16] 15 is a diagram illustrating a part to be taken out of the body from the state shown in FIG. 14. FIG. [Figure 17]2 is a diagram showing a procedure for anastomosing severed stumps in a procedure using the biological organ closure device shown in FIG. 1. FIG. [Figure 18] 2 is a diagram showing a procedure for anastomosing severed stumps in a procedure using the biological organ closure device shown in FIG. 1. FIG. [Figure 19] 2 is a diagram showing a procedure for anastomosing severed stumps in a procedure using the biological organ closure device shown in FIG. 1. FIG. [Figure 20] FIG. 10 is a view showing a state in which a deformation portion constituting the biological organ closing device according to Modification 1 of the first embodiment is contracted. [Figure 21] FIG. 10 is a view showing a state in which a deformation portion constituting the biological organ closing device according to Modification 1 of the first embodiment is expanded. [Figure 22] FIG. 10 is a view showing a state in which a frame member constituting a biological organ closing device according to a second embodiment is contracted. [Figure 23] FIG. 10 is a view showing a state in which a frame member constituting a biological organ closing device according to a second embodiment is expanded. DETAILED DESCRIPTION OF THE INVENTION

[0010] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. The embodiments shown here are merely examples for embodying the technical concept of the present invention and are not intended to limit the present invention. Furthermore, all other embodiments, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included within the scope and spirit of the present invention, as well as within the scope of the claims and their equivalents.

[0011] Furthermore, for the convenience of illustration and ease of understanding, the drawings attached to this specification may be represented schematically with the scale, aspect ratio, shape, etc. appropriately changed from the actual product, but these are merely examples and do not limit the interpretation of the present invention.

[0012] In the following description, ordinal numbers such as "first" and "second" are used, but unless otherwise specified, these are used for convenience and do not stipulate any particular order.

[0013] The biological organ closing device 100 will be described below with reference to Figures 1 to 7. Figure 1 is a schematic diagram showing the biological organ closing device 100 according to the first embodiment. Figure 2 is a schematic diagram showing the indwelling section Dt constituting the biological organ closing device 100 of Figure 1. Figure 3 is a longitudinal view of the indwelling section Dt of Figure 2. Figure 4 is a diagram showing the state in which the deformable section 10 is expanded by the expansion section 50 shown in Figure 1. Figure 5 is a diagram showing the state in which the deformable section 10 is contracted by the moving member 32 of the contraction section 30 shown in Figure 2.

[0014] The biological organ closure device 100 according to this embodiment is used, for example, to close a biological organ Bg in a procedure for resecting a tumor, such as cancer, present in a patient's rectum. The biological organ closure device 100 includes an indwelling portion Dt and a delivery device Dv, as outlined in FIG. 1 . The details are described below.

[0015] (Detention Department) The indwelling section Dt is configured to be able to be placed near the biological organ Bg to be closed. The indwelling section Dt includes a deforming section 10, a puncturing section 20, and a contracting section 30, as shown in FIG.

[0016] (deformed part) The deformable section 10 is provided to close the biological organ Bg of a patient. As shown in Figures 1 to 5, the deformable section 10 is expandable and contractible, and is configured to form a ring shape at least when expanded. The deformable section 10 is configured to be contractible radially inward by forming any number of folds or the like around the periphery of the ring shape. Note that "radial direction" in this specification refers to the direction in which the ring shape of the deformable section 10 in Figures 3, 10, 12, etc. deforms. The deformable section 10 is configured to be integrated with the biological organ Bg when the puncturing section 20, which will be described later, is inserted into the biological organ Bg. Furthermore, the deformable section 10 is configured to be contractible so as to close the biological organ Bg from the state in which the puncturing section 20 is inserted into the biological organ Bg.

[0017] The deformable portion 10 is not particularly limited in terms of its specific material, as long as it can expand and contract and has sufficient strength to pull the biological organ Bg radially inward when contracted. The deformable portion 10 is not particularly limited in terms of its material, but examples of materials that can be used include: polyethylene, polypropylene, polyolefins such as ethylene-propylene copolymers, polyesters such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymers, cross-linked ethylene-vinyl acetate copolymers, and thermoplastic resins such as polyurethane, polyamide, polyamide elastomer, polystyrene elastomer, silicone rubber, and latex rubber. The deformable portion 10 can also be configured so that its outer surface is provided with an elastic member including a soft resin material, a sponge-like substance, or an elastic (or relatively highly elastic) material.

[0018] (Puncture site) As shown in Figure 3, the puncturing section 20 is provided on the outer surface of the deformable section 10 and is configured to be able to puncture the inner wall surface of the biological organ Bg when placed in the biological organ Bg. The puncturing section 20 is attached to the deformable section 10 and configured to have a sharp tip, such as a needle, that points radially outward. The puncturing sections 20 are arranged at approximately equal intervals around the circumference of the ring shape of the deformable section 10 (see Figure 3, etc.). The puncturing section 20 can be provided with protruding sections 21 with arrow-shaped tips that protrude outward in a direction intersecting the insertion direction so that the punctured area does not or is difficult to remove when puncturing the biological organ Bg, such as the intestine.

[0019] The puncturing section 20 may be made of any material as long as it can displace the punctured surrounding biological organ Bg radially inward when the deformable section 10 is contracted radially inward from the punctured state. The puncturing section 20 may include a material such as stainless steel. By puncturing the biological organ Bg with the puncturing section 20, the deformable section 10 can be integrated with the biological organ Bg (see FIGS. 11 and 13).

[0020] (Contraction section) The contraction section 30 is configured to be able to contract the expanded deformation section 10. As shown in FIG. 1 etc., the contraction section 30 includes a linear first elongated member 31 and a moving member 32. The first elongated members 31 are connected and arranged at approximately equal intervals in the circumferential direction of the ring shape of the deformation section 10. The first elongated members 31 can be configured to include a material strong enough to contract and deform the deformation section 10 by pulling.

[0021] The moving member 32 has an insertion hole h through which the first elongated members 31 can pass while being brought close to one another (see FIG. 5), and is configured to be movable along the longitudinal direction of the first elongated members 31. When the moving member 32 is brought close to the deformation section 10 along the longitudinal direction, the moving member 32 displaces the first elongated members 31 in the vicinity of the deformation section 10 so as to draw them radially inward (see FIG. 5). This causes the deformation section 10 connected to the first elongated members 31 to contract and deform, and when the puncturing section 20 is puncturing the biological organ Bg, it is possible to close the biological organ Bg punctured by the puncturing section 20.

[0022] Delivery Device As shown in Fig. 1, the delivery device Dv is configured to include a grip portion 40 and an expansion portion 50. The grip portion 40 is provided on the base end side (hand side) of the delivery device Dv and is configured to be sized so that it can be grasped by the fingers of a medical professional such as a doctor. In this embodiment, the grip portion 40 communicates with the internal space of the expansion portion 50, and by increasing the gripping force, the fluid present in the internal space on the hand side can be supplied to the expansion portion 50 side, which has a balloon member or the like, thereby providing an expandable shape for the expansion portion 50.

[0023] The expansion section 50 is provided on the tip side (distal side) of the delivery device Dv and is configured to be radially expandable and contractible. The expansion section 50 has an internal space into which fluid can be supplied and discharged, and is configured to include a balloon member that can expand and contract as the volume of the internal space changes due to the supply and discharge of fluid. The expansion section 50 can be arranged inside the ring-shaped portion of the deformation section 10 and, in this embodiment, is configured separately from the deformation section 10. The expansion section 50 is configured to expand the deformation section 10 by expanding from a state in which it is arranged inside the ring-shaped portion of the deformation section 10 (see Figures 1 and 4). The material of the balloon member that constitutes the expansion section 50 can be the same as that described above for the deformation section 10.

[0024] (stapler) Fig. 6 is a schematic diagram showing a stapler 200 used in a procedure using the biological organ closure device 100 shown in Fig. 1. Fig. 7 is a diagram showing the tip of the first engagement instrument 210 and the second engagement instrument 270 of the stapler 200 shown in Fig. 6. The stapler 200 is configured to anastomose the stumps of the severed biological organ Bg. As shown in Fig. 6, the stapler 200 includes the first engagement instrument 210 and the second engagement instrument 270.

[0025] 18 etc., the first engaging instrument 210 is placed on one side when anastomosis of the biological organ Bg is performed using the biological organ closure device 100. The first engaging instrument 210 is configured to be able to abut against the first to-be-joined portion, which is the stump of the biological organ Bg.

[0026] The second engaging instrument 270 is positioned on the opposite side of the first engaging instrument 210 with respect to the biological organ closure device 100 during anastomosis, and is configured to be able to abut against the second site to be joined, which is the stump of the biological organ Bg. Details will be described below. The first engaging instrument 210 may be called a trocar, and the second engaging instrument 270 may be called an anvil. These will be described in detail below.

[0027] <First engagement device> As shown in FIGS. 6 and 7, the first engaging device 210 includes an elongated member 220, a positioning portion 230, a discharging portion 240, a punching portion 250, and an operating portion 260.

[0028] The elongated member 220 corresponds to the main body of the first engaging device 210. As shown in Fig. 7, the elongated member 220 has a space S at the tip in the longitudinal direction, in which the shaft of the positioning part 230 can relatively move forward and backward. The cross section of the elongated member 220 intersecting the axial direction is configured to be hollow and circular.

[0029] In this embodiment, the elongated member 220 extends linearly in the longitudinal direction and has bent portions, but the elongated member does not need to have bent portions as long as it can achieve the anastomosis function and punching function described below.

[0030] The positioning unit 230 includes a long shaft. The shaft of the positioning unit 230 is configured to be relatively movable forward and backward from the space S at the tip in the longitudinal direction of the elongated member 220, as shown in Fig. 7. The positioning unit 230 is configured to be insertable into the inner cavity of the shaft 310 of the second engagement device 270, which will be described later.

[0031] The release section 240 is configured to be able to release a plurality of staples in a substantially annular shape to join the first and second joint portions. The release section 240 is formed in a substantially disk shape at the tip end side in the longitudinal direction of the elongated member 220. The release section 240 is configured by providing a plurality of staple release points along the circumferential direction at the tip end of the elongated member 220.

[0032] The punching portion 250 is disposed radially inward of the release portion 240 at the tip of the elongated member 220, and is configured to punch out the first and second joined portions radially inward. As shown in Fig. 7, the punching portion 250 is configured to have an annular blade that punches out the first and second joined portions radially inward of the release portion 240. The shape of the punching portion 250 can be configured to be a perfect circle when viewed in a plan view from the longitudinal direction, but the shape of the punching portion 250 may be an ellipse or the like as long as it can punch out portions that are not required for anastomosis.

[0033] The operating unit 260 is configured to be able to operate the positioning unit 230, the discharging unit 240, and the punching unit 250. The operating unit 260 includes a rotating unit 261 and a handle 262, as shown in FIG.

[0034] The rotating part 261 is provided at the base end (base end side) in the longitudinal direction of the elongated member 220. The rotating part 261 is configured to be rotatable relative to the elongated member 220, with the longitudinal direction at the base end side of the elongated member 220 serving as a rotation axis. The rotating part 261 is configured so that, in a state in which the second engaging device 270 is engaged with the first engaging device 210, the first engaging device 210 and the second engaging device 270 can be moved relatively closer to or farther away from each other by rotating relative to the elongated member 220.

[0035] The handle 262 is configured to be grippable by the user together with the base end (base end side) of the elongated member 220. The handle 262 is rotatably connected to the elongated member 220 by a rotation shaft 263. When gripped by the user, the handle 262 rotates around the rotation shaft 263 and moves relatively close to the elongated member 220. This allows staples to be released from the release portion 240 and the annular blade of the punching portion 250 to protrude from the tip of the elongated member 220.

[0036] <Second engagement device> The second engaging instrument 270 is configured to be able to clamp the biological organ closure device 100 together with the first engaging instrument 210 via the first and second joined portions. The second engaging instrument 270 includes a head 280, an abutment portion 290, and a shaft 310, as shown in FIG.

[0037] The head 280 is disposed adjacent to the elongated member 220 of the first engaging device 210, particularly the distal end side thereof, when the first engaging device 210 and the second engaging device 270 are engaged with each other. In this embodiment, the head 280 is configured in a substantially circular plate shape as shown in Figures 6 and 7, and its cross-sectional shape is configured to be the same as or similar to the circular shape of the elongated member 220.

[0038] The abutting portion 290 corresponds to the side of the first engaging device 210 in the head 280, and is configured to be able to abut against a plurality of staples discharged from the discharge portion 240. The staples discharged from the discharge portion 240 abut against the abutting portion 290 and deform, thereby joining the first and second joint portions together.

[0039] The shaft 310 is configured to be able to engage with the shaft of the positioning portion 230 of the first engagement device 210.

[0040] The shaft 310 has a space for accommodating the shaft of the positioning portion 230 of the first engagement device 210. The shaft 310 is configured to fit with the shaft of the positioning portion 230, which allows the first engagement device 210 and the second engagement device 270 to be aligned.

[0041] (Treatment method) Next, an anastomosis of a biological organ Bg using the biological organ closure device 100 according to this embodiment will be described. FIG. 8 is a flowchart showing the steps of a treatment method using the biological organ closure device 100, and FIGS. 9 to 19 are diagrams for explaining the treatment method. The following description will be given of a case where the procedure using the biological organ closure device 100 is TaTME, but this is merely an example, and the application of the biological organ closure device 100 is not limited to TaTME. The following description will also be given of a case where a lumen is formed in the biological organ Bg to be closed, as an example. The treatment method according to this embodiment can be summarized with reference to FIG. 8, and includes steps of delivering the biological organ closure device 100 to the target site (S1), expanding the deformable portion 10 (S2), and contracting the deformable portion 10 (S3). A detailed description will be given below.

[0042] In the TaTME procedure, a predetermined number of ports (small incisions) are made in the abdominal cavity, and a doctor or other medical professional performs treatment through the abdominal ports and the anus.

[0043] In the TaTME procedure, lymph nodes located around the cancer on the abdominal cavity side B1 are removed (lymph node dissection). Then, when removing the cancerous region Cn from the body, which is resected in the anal intestinal tract A2 (corresponding to the anal side of the large intestine), a procedure is performed to close the lumen of the vital organ Bg near the cancerous region Cn in the intestinal tract.

[0044] In a procedure to close the lumen of a biological organ Bg, a surgeon such as a doctor introduces a biological organ closure device 100 into the biological organ Bg, such as the intestinal tract, through the anus. When introducing the biological organ closure device 100 into the lumen of the biological organ Bg, the biological organ closure device 100 can be inserted into the biological lumen while covered with a cylindrical cover 400 to prevent the puncture section 20 from unintentionally damaging the wall of the introduced site (see FIG. 9). Delivery to the target site can be performed based on the distance from the anus (S1).

[0045] 9, once the biological organ closure device 100 has been delivered to the desired site near the cancer site Cn, the surgeon increases the gripping force (grips) of the gripping portion 40 to expand the expansion portion 50 of the delivery device Dv. This causes fluid to be supplied to the internal space of the expansion portion 50, increasing the volume of the expansion portion 50 and expanding the expansion portion 50. Because the expansion portion 50 is disposed radially inward of the deformation portion 10, the expansion of the expansion portion 50 causes it to come into contact with the deformation portion 10, expanding the deformation portion 10 radially outward (S2).

[0046] As a result, the deformable portion 10 moves from a contracted state as shown in FIG. 10 to contact the inner wall surface of the biological organ Bg as shown in FIGS. 11 and 12, and the puncturing portion 20 punctures the inner wall surface of the biological organ Bg, such as the intestinal tract. By expanding the deformable portion 10 radially outward with the expansion portion 50 positioned radially inside the deformable portion 10, the expansion portion 50 supports the puncturing portion 20 so as to prevent or suppress the puncturing portion 20 from improperly puncturing the biological organ Bg. This allows the protruding portion 21, in particular, of the puncturing portion 20 to exert a fixing force on the biological organ Bg, such as the intestinal tract, and the retention portion Dt, including the deformable portion 10, to become one with the biological organ Bg, such as the intestinal tract. The puncturing portion 20 then displaces so as to expand approximately uniformly circumferentially along the radial direction relative to the biological organ Bg, such as the intestinal tract. This allows the biological organ closure device 100 to be firmly fixed to the biological organ Bg, such as the intestinal tract.

[0047] Once it is confirmed that the puncturing section 20 has been inserted into the intestinal tract and that the retention section Dt has become one with the biological organ Bg, the surgeon contracts the expansion section 50 and pulls out the delivery device Dv from the retention section Dt (see FIG. 13). Next, as shown in FIG. 14, the surgeon moves the movable member 32 of the contraction section 30 toward the deformation section 10. This draws the first elongated member 31 near the deformation section 10 radially inward, causing the deformation section 10 to deform and contract radially inward. Here, because the deformation section 10 is one with the biological organ Bg, such as the intestinal tract, by the puncturing section 20, the contraction of the deformation section 10 radially inward causes the biological organ Bg near the deformation section 10 to contract radially inward as if being squeezed, as shown in FIG. 14 (S3).

[0048] As a result, the site in the biological organ Bg, such as the intestine, where the retention portion Dt is retained is closed. Furthermore, the deformable portion 10 deforms radially inward as described above when contracting. Therefore, the site can be closed while maintaining the length of the biological organ Bg, such as the intestine, to some extent. Note that, in this application, the lumen being closed includes not only a state in which the contents of the lumen cannot pass through the closed portion, but also a state in which the lumen contracts and the contents of the lumen have difficulty moving through the closed portion.

[0049] Next, the surgeon uses an electric scalpel, endoscope, etc. from the anal side B2 and abdominal cavity side B1 to separate and detach the area to be extracted from the surrounding biological organs Bg, such as the intestines, and adhered tissues (see Figure 15). This makes the biological organs Bg, such as the intestines, movable. The area rg to be extracted from the body in TaTME can be set as shown in Figure 16.

[0050] Next, the surgeon pulls out the biological organ Bg, such as the intestine, containing the cancerous region Cn from the anus to the outside of the body, and excises the cancerous region Cn from the pulled out biological organ Bg, such as the intestine, using scissors or the like (specimen extraction). When removing the cancerous region Cn, the biological organ closure device 100 is separated from the intestine together with the cancerous region Cn. The biological organ Bg, such as the intestine, from which the cancerous region Cn has been excised is anastomosed using the stapler 200 described above as follows.

[0051] The second engagement instrument 270 of the stapler 200 is inserted into a biological organ Bg, such as the intestinal tract A1 on the oral side (peritoneal cavity side) that has been pulled out of the body, and with the base of the shaft 310 protruding from the opening of the intestinal tract A1 on the oral side, the opening of the intestinal tract A1 on the oral side is purse-string sutured to form a sutured portion A11. Here, the intestinal tract A1 on the oral side corresponds to the large intestine on the oral side. The outer surface of the sutured portion A11 is partially projected toward the convex side as a result of the suturing (see FIG. 17). Thereafter, the intestinal tract A1 on the oral side is returned to the body and accommodated with the second engagement instrument 270 still attached.

[0052] Next, the surgeon inserts the first engagement instrument 210 from the anus into the intestinal tract A2 on the anal side. By inserting the first engagement instrument 210 into the intestinal tract A2 on the anal side, a through-hole A21 is formed.

[0053] Next, the surgeon engages the positioning portion 230 of the first engagement instrument 210 and the shaft 310 of the second engagement instrument 270 at a spaced apart position. Next, the surgeon rotates the rotating portion 261 to bring the first engagement instrument 210 and the second engagement instrument 270 relatively closer to each other, as shown in Fig. 18. This brings the intestinal tract A1 on the oral side and the intestinal tract A2 on the anal side closer to each other.

[0054] Next, the surgeon clamps the areas around the through-hole A21 formed in the intestinal wall of the oral side intestinal tract A1 and the intestinal wall of the anal side intestinal tract A2 between the first engagement instrument 210 and the second engagement instrument 270. Next, the surgeon rotates the handle 262 of the operation unit 260 of the stapler 200 around the rotation axis 263 to protrude the annular blade of the punching unit 250. Then, a portion of the mouth of the oral side intestinal tract A1 and a portion of the anal side intestinal tract A2 that are clamped between the first engagement instrument 210 and the second engagement instrument 270 are excised, and the periphery of the excised area is joined in a substantially annular shape with staples (not shown).

[0055] Next, as shown in Fig. 19, the surgeon removes the stapler 200 from the anus, for example, via the anal-side intestinal tract A2 to the outside of the living body. At this time, the region of the first engaging instrument 210 that is configured on the inside of the outer diameter d of the punching portion 250 is removed together with the stapler 200 to the outside of the living body. As a result, the portion of the biological organ closure device 100 that is located radially inward of the punching portion 250 is removed without remaining in the body. Note that, in the above treatment method, when the cancerous site Cn is excised, the intestinal tract containing the cancerous site Cn is pulled out of the body from the anus. However, in addition to the above, the intestinal tract containing the cancerous site Cn may also be pulled out of the body from the abdominal cavity.

[0056] As described above, the biological organ closure device 100 according to this embodiment has a deformable portion 10 and a puncturing portion 20. The deformable portion 10 is expandable and contractible and is configured to form a ring shape at least when expanded. The puncturing portion 20 is provided on the outer surface of the deformable portion 10 and is configured to be able to puncture the biological organ Bg. The deformable portion 10 is configured to be able to become one with the biological organ Bg when the puncturing portion 20 is inserted into the biological organ Bg, and to be contractible so as to close the biological organ Bg from the state in which the puncturing portion 20 is inserted into the biological organ Bg.

[0057] There are two types of surgical procedures for rectal cancer, such as those mentioned above: open surgery and laparoscopic surgery. Laparoscopic surgery is becoming more popular due to its advantages over open surgery, such as smaller incisions, less pain, faster recovery, and less bleeding. However, the rectum is located in the narrow space of the pelvis and is surrounded by nerves, the prostate, the uterus, and the vagina, so it must be removed without damaging it, requiring advanced techniques. Laparoscopic surgery has traditionally only been approached from the abdominal cavity, in which case instruments such as forceps are inserted perpendicular to the tumor, making operation difficult.

[0058] In response to this, a technique called TaTME, which approaches from both the anus and abdominal cavity as mentioned above, is becoming increasingly popular. Using TaTME, the approach from the anal side makes it easier to secure a margin between the cancer cells and the tumor. TaTME is considered useful for men, obese patients, and patients with relatively large tumors. By using TaTME, it is possible to avoid resection of the rectum near the anus, thereby increasing the likelihood of preserving anal function after surgery. However, conventional techniques such as TaTME require the use of a purse string suture, in which a purse-string suture is placed and ligated from the inside of the intestine before separating it from the anal side.

[0059] The Purse String Suture is a difficult technique that requires forceps manipulation under a transanal endoscope, and training is essential. Currently, it is one of the conditions for performing TaTME. If the Purse String Suture is incomplete, cancer cells may leak into the abdominal cavity, which is thought to be one of the causes of cancer recurrence.

[0060] In contrast, in this embodiment, the deformable portion 10 of the biological organ closure device 100 is placed inside a biological organ Bg, such as the intestine, and the ring shape of the deformable portion 10 is contracted to close the biological organ Bg. This allows for a simple approach to the inside of the biological organ Bg, such as the intestine, without performing a purse string suture to close the biological organ Bg in the body lumen, as is done in TaTME. Furthermore, since the biological organ closure device 100 eliminates the need for a purse string suture in procedures such as TaTME, the procedure time can be reduced accordingly. Furthermore, the biological organ closure device 100 includes the puncture portion 20, as described above. Therefore, even in cases where the distance from the lesion to the anus is short, such as in procedures for rectal cancer, the biological organ closure device 100 is less likely to shift longitudinally relative to the biological organ Bg, making it easier to ensure a margin between the site to be closed and the lesion.

[0061] The expansion section 50 of the delivery device Dv also includes a balloon member. The balloon member of the expansion section 50 is expandable and contractable by supplying and discharging fluid, and is configured to be separate from the deformation section 10 and be positionable inside the deformation section 10, allowing the deformation section 10 to expand by expanding while positioned inside the deformation section 10. This configuration allows the deformation section 10 to expand so as to become integrated with the target site to be closed. Furthermore, since the expansion section 50 includes a balloon member, the deformation section 10 integrated with the puncture section 20 can be easily placed at the target site.

[0062] The biological organ closure device 100 also includes a first elongated member 31 and a movable member 32. The first elongated member 31 is ring-shaped and configured to be provided in multiple positions around the deformable portion 10. The movable member 32 is configured to be movable along the longitudinal direction of the multiple first elongated members 31 and to have insertion holes h through which the multiple first elongated members 31 can be inserted. The movable member 32 is configured to draw the first elongated members 31 near the deformable portion 10 radially inward when brought close to the deformable portion 10 along the longitudinal direction, thereby contracting and deforming the deformable portion 10. With this configuration, the deformable portion 10 integrated with the intestinal tract or the like can be contracted to close the target biological organ Bg. Furthermore, since the biological organ closure device 100 includes the first elongated member 31 and the movable member 32, the deformable portion 10 is deformed so as to be drawn radially inward when contracted. Therefore, by suppressing the displacement of the deformable portion 10 in the longitudinal direction relative to the biological organ Bg, the accuracy of the closing position of the biological organ Bg can be improved.

[0063] The puncturing unit 20 is also configured to have a protruding portion 21 that can puncture the biological organ Bg and protrudes outward in a direction intersecting the insertion direction. With this configuration, after the puncturing unit 20 punctures the intestinal tract or the like, the punctured portion of the puncturing unit 20 does not or is difficult to come out of the biological organ Bg, such as the intestinal tract, and this makes it easier to reliably close the biological organ Bg when the deformable unit 10 is contracted.

[0064] The deformable portion 10 can also be configured to have an elastic member on its outer surface. By configuring it in this way, the elastic member can flexibly accommodate changes in the application site of the biological organ closure device 100 due to factors such as age, sex, and position of the rectum.

[0065] (Modification 1 of the first embodiment) Figure 20 is a diagram showing the state in which the deformable portion 10a is contracted in the biological organ closing device according to variant 1 of the first embodiment, and Figure 21 is a diagram showing the state in which the deformable portion 10a is expanded in the biological organ closing device according to variant 1.

[0066] In the first embodiment, it has been described that the contraction section 30 includes the first elongated member 31 and the movable member 32, and that by bringing the movable member 32 close to the deformation section 10, the first elongated member 31 near the deformation section 10 is displaced radially inward to contract the deformation section 10. However, the deformation section 10 can be configured as follows to contract the deformation section.

[0067] The biological organ closure device according to this modification includes an indwelling section Dta and a delivery device Dv. As shown in Fig. 20, the indwelling section Dta includes a deforming section 10a, a puncturing section 20, and a contracting section 30a. Note that the puncturing section 20 and the delivery device Dv in the indwelling section Dta are the same as those in the first embodiment, and therefore will not be described here.

[0068] In this modification, the contraction section 30a is configured to include a linear second elongated member 31a. The second elongated member 31a is configured to be retractable by the fingers of a surgeon, such as a doctor. Similarly to the first embodiment, the deformation section 10a is formed in a ring shape and has an internal space capable of accommodating a portion of the second elongated member 31a of the contraction section 30a. The second elongated member 31a of the contraction section 30a is arranged in the internal space of the deformation section 10a along the circumferential direction of the deformation section 10a and is exposed to the outside at two points from the internal space. The second elongated member 31a is configured so that the length of the second elongated member 31a exposed from the internal space of the deformation section 10a increases when the surgeon pulls it. The deformation section 10a is configured to be contractible by changing the exposed length of the second elongated member 31a from the internal space of the deformation section 10a.

[0069] In this modified example, the deforming portion 10a is the same as in the first embodiment except that it has an internal space for accommodating the second elongated member 31a, and therefore a description of the common parts will be omitted. In addition, the second elongated member 31a of the contracting portion 30a changes the circumferential length of the deforming portion 10a by pulling, so a material can be used that will not break the second elongated member 31a even when pulled.

[0070] In the treatment method using the biological organ closure device of this modification, the delivery of the biological organ closure device to the target site (S1 in FIG. 8) and the operation of expanding the deformable portion 10a to integrate it with the biological organ Bg (S2 in FIG. 8) are the same as in the first embodiment. Therefore, their explanations are omitted. In this modification, in the state shown in FIG. 13, the second elongated member 31a is taken into the deformable portion 10a by the expansion portion 50, and the deformable portion 10a enters the expanded state as shown in FIG. 21.

[0071] Next, after the surgeon confirms that the indwelling portion Dta, including the deformable portion 10a, has been integrated with the biological organ Bg by the puncturing portion 20, the surgeon contracts the expansion portion 50 and withdraws the delivery device Dv from the indwelling portion Dta. Then, while the puncturing portion 20 is inserted into the biological organ Bg, such as the intestinal tract, the surgeon pulls the second elongated member 31a, exposed from the internal space of the deformable portion 10a, toward the proximal end (proximal side) while preventing the deformable portion 10a from being pulled toward the proximal end. This increases the portion of the second elongated member 31a exposed from the internal space of the deformable portion 10a, reducing the circumferential length of the deformable portion 10a and causing the deformable portion 10a to transition from the expanded state to the contracted state. As a result, the biological organ Bg, such as the intestinal tract, which has been integrated with the deformable portion 10a by the puncturing portion 20, is deformed so as to contract radially inward together with the deformable portion 10a (see FIGS. 14 and 20). The subsequent operation of the biological organ closing device is similar to that of the first embodiment, and therefore a description thereof will be omitted.

[0072] As described above, in this modified example, the contraction section 30a includes the second elongated member 31a, which is disposed in the internal space of the deformable section 10a along the circumferential direction of the deformable section 10a and is exposed to the outside at at least two points from the inside. The second elongated member 31a is configured to contract the deformable section 10a by being pulled so as to increase the length exposed to the outside from the internal space of the deformable section 10a. In this way, the deformable section 10a can be contracted and the biological organ Bg can be closed by the relatively simple operation of pulling the second elongated member 31a.

[0073] (Second embodiment) Figure 22 is a diagram showing the frame member 11b of the biological organ closing device 100 according to the second embodiment in a contracted state, and Figure 23 is a diagram showing the frame member 11b of the biological organ closing device 100 in an expanded state.

[0074] In the first embodiment, the indwelling portion Dt placed in the biological organ Bg and the delivery device Dv that delivers the indwelling portion Dt to the target site are separate entities, and the delivery device Dv is removed after the indwelling portion Dt is placed. However, the biological organ closure device can be configured as follows.

[0075] As shown in FIGS. 22 and 23, the biological organ closure device 100b includes a deforming portion 10b, a puncturing portion 20b, and a contracting portion 30b.

[0076] The deformation section 10b includes a frame member 11b and a membrane member 12b. The frame member 11b is connected to the shaft 31b of the contraction section 30b at a base point bp so that the angle between the shaft 31b and the frame member 11b can be changed, and multiple frame members 11b are provided. The frame member 11b is made of a metal such as stainless steel or a high-hardness plastic, thereby providing high rigidity. The frame member 11b is configured to be able to expand and contract with the base point bp as a reference, as shown in Figures 22 and 23.

[0077] The membrane member 12b is configured as one unit with the frame member 11b and is connected to multiple frame members 11b to form a curved surface when the frame members 11b are expanded. The membrane member 12b is configured to change its surface tension in response to the expansion and contraction of the frame members 11b. That is, when the frame members 11b are in the contracted state shown in FIG. 22, the surface tension of the membrane member 12b is relatively small, and when the frame members 11b are in the expanded state shown in FIG. 23, the surface tension is relatively high. The membrane member 12b can be made of any of the materials exemplified for the deformation section 10.

[0078] The puncturing section 20b is configured to be provided at the tip of the frame member 11b, on the opposite side of the base point bp, which is the connection point with the shaft 31b. When the frame member 11b is in the expanded state shown in Figure 23, the puncturing section 20b faces radially outward and is configured to be able to puncture the inside of the biological organ Bg. When the frame member 11b is in the expanded state, the puncturing section 20b provided at the tip of the frame member 11b is punctured into the inside of the biological organ Bg, and the frame member 11b is configured to be able to close a part of the biological organ Bg by contracting the frame member 11b. The shape and material of the puncturing section 20b can be configured the same as the puncturing section 20 of the first embodiment.

[0079] The contraction section 30b includes a shaft 31b, a movable member 32b, and a connecting member 33b. The shaft 31b is attached so that the angle between the frame member 11b and the shaft 31b at the base point bp can be changed, and the movable member 32b is movably attached. The shaft 31b is configured to have high rigidity by including metal such as stainless steel or high-hardness plastic.

[0080] The movable member 32b is formed in a cylindrical shape and is provided so as to be movable in the longitudinal direction relative to the shaft 31b while the shaft 31b is inserted therethrough. The movable member 32b is configured so as to be movable in the longitudinal direction relative to the shaft 31b, thereby changing the frame member 11b between an expanded state and a contracted state. Like the frame member 11b, the movable member 32b is configured to include a material such as a relatively hard plastic so that the angle between the frame member 11b and the shaft 31b can be changed.

[0081] The connecting members 33b are configured to connect the moving members 32b and the frame members 11b. The connecting members 33b are configured to be provided in a one-to-one correspondence with the number of frame members 11b. The connecting members 33b can be configured to include a material such as a metal such as stainless steel or a highly hard plastic, just like the frame members 11b.

[0082] In a treatment method using the biological organ closure device 100b according to this embodiment, the surgeon delivers the biological organ closure device 100b from the anus to a desired site with the frame member 11b contracted as shown in Fig. 22 (S1 in Fig. 8). Once the biological organ closure device 100b has reached the desired site, the surgeon moves the movable member 32b relative to the shaft 31b so as to approach the base point bp.

[0083] As a result, the connecting member 33b displaces the radially outer periphery of the frame member 11b radially outward as shown in FIG. 23, and the frame member 11b and the membrane member 12b deform so as to expand (S2, see FIG. 23). As described above, the puncturing portion 20b is configured to face radially outward when the frame member 11b is in an expanded state. Therefore, as the frame member 11b expands, the puncturing portion 20b punctures the biological organ Bg, such as the intestinal tract, and the biological organ closure device 100b, including the deformable portion 10b, becomes one with the biological organ Bg (S2 in FIG. 8). At this time, the connecting member 33b supports the puncturing portion 20b so as to prevent or suppress the puncturing portion 20b from being unable to properly puncture the biological organ Bg.

[0084] Next, the surgeon moves the movable member 32b relative to the shaft 31b so as to move it away from the base point bp. As a result, the outer peripheries of the frame member 11b and the membrane member 12b are drawn radially inward, and the frame member 11b and the membrane member 12b are deformed so as to contract, as shown in Figure 22. As a result, the biological organ Bg, such as the intestinal tract, which is integrated with the frame member 11b, is drawn radially inward by the puncture unit 20 located on the outer periphery of the frame member 11b, and the puncture site of the puncture unit 20b deforms so as to close the biological organ Bg (S3, see Figure 22).

[0085] In this embodiment, the shaft 31b is integral with the frame member 11b, which expands and contracts in the biological organ Bg. Therefore, the biological organ closure device 100b including the shaft 31b is not removed from the biological organ Bg, and the cancerous site Cn and other lesions are pulled out of the body and resected. The subsequent operations are the same as in the first embodiment, and therefore will not be described here.

[0086] As described above, the biological organ closure device 100b includes a shaft 31b, a frame member 11b, a movable member 32b, and a connecting member 33b. A plurality of frame members 11b are provided and connected to the base point bp of the shaft 31b so that the angle formed with the shaft 31b can be changed. The movable member 32b is provided so as to be movable in the longitudinal direction of the shaft 31b. The connecting member 33b is configured to connect the movable member 32b to the frame member 11b. The frame member 11b is configured to be in an expanded state when the movable member 32b approaches the longitudinal base point bp and to be deformed to a contracted state when moved away from the base point bp. The puncture section 20b located at the distal end of the frame member 11b is configured to be able to puncture the inside of the biological organ Bg in the expanded state. The frame member 11b is configured so that, in the expanded state, the puncturing section 20b located on the distal end side is punctured into the inside of the biological organ Bg, and then contracted to close off a part of the biological organ Bg.

[0087] With this configuration, the procedure for closing the biological organ Bg can be performed by a relatively simple method of moving the moving member 32b along the longitudinal direction of the shaft 31b.

[0088] The present invention is not limited to the above-described embodiments, and various modifications are possible within the scope of the claims. In the first embodiment and other embodiments, the detention section Dt including the deformable section 10 is delivered to the target site, expanded, and integrated with the biological organ Bg by the puncture section 20. An adhesive or a gel-like drug may be applied to the radially outer surface of the deformable section 10 to promote integration with the biological organ Bg. Furthermore, while the first embodiment describes the detention section Dt and the delivery device Dv as being separable, the present invention is not limited thereto, and the detention section Dt and the delivery device Dv constituting the biological organ closure device 100 of the first embodiment may be configured to be inseparable, as in the second embodiment.

[0089] In the second embodiment, the deformation section 10b includes the frame member 11b and the membrane-like member 12b. However, as long as the deformation section 10b can be integrated with the biological organ Bg by the puncture section 20b in the expanded state and can close the biological organ Bg by transitioning from the expanded state to the contracted state, the deformation section of the second embodiment may include the frame member 11b but not the membrane-like member 12b.

[0090] Furthermore, although the biological organ Bg to be closed by the biological organ closure device has been described above as including a lumen, this is not limited thereto. In addition to the above, the biological organ closure device as described in the first and second embodiments may also be used to close a biological organ Bg such as the foramen ovale in cases of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect). [Explanation of symbols]

[0091] 10, 10a, 10b deformation part, 11b frame members; 20 puncture site, 21 protrusion, 20b puncture part (tip of frame member), 30, 30a, 30b contraction portion, 31 first elongated member, 31a second elongated member; 31b shaft, 32 moving parts, 32b moving member, 33b connecting member, 50 expansion part (balloon member), 100, 100b Bio-organ closure device; Bg vital organs, bp base point, h Insertion hole.

Claims

1. a deformation portion that is expandable and contractible and forms a ring shape at least when expanded; a puncture portion provided on an outer surface of the deformation portion and capable of puncturing a biological organ; a plurality of first elongated members provided in the deformation portion in a circumferential direction of the deformation portion; a moving member that is movable along the longitudinal direction of the plurality of first elongated members and has insertion holes through which the plurality of first elongated members can be inserted, the deforming section can be integrated with the biological organ when the puncturing section is inserted into the biological organ, and contracts to close the biological organ from the state in which the puncturing section is inserted into the biological organ; The moving member is capable of approaching the deformation portion along the longitudinal direction, thereby drawing the first elongate member near the deformation portion radially inward and contracting the deformation portion, thereby forming a biological organ closure device.

2. A deformable portion that is expandable and contractible and forms a ring shape at least when expanded; a puncture portion provided on an outer surface of the deformation portion and capable of puncturing a biological organ; a second elongated member that is disposed inside the deformation portion along a circumferential direction of the deformation portion and is exposed to the outside at at least two locations from the inside, the deforming section can be integrated with the biological organ when the puncturing section is inserted into the biological organ, and contracts to close the biological organ from the state in which the puncturing section is inserted into the biological organ; A biological organ closure device, wherein the deformable portion can be contracted by pulling the second elongated member so that the exposed length of the second elongated member that is exposed from the inside to the outside of the deformable portion increases.

3. A deformation portion that is expandable and contractible and forms a ring shape at least when expanded; a puncture portion provided on an outer surface of the deformable portion and capable of puncturing a biological organ, the puncture unit includes a protrusion that can puncture the biological organ and protrudes outward in a direction intersecting with the insertion direction, The deforming portion can be integrated with the biological organ when the puncturing portion is inserted into the biological organ, and contracts to close the biological organ from the state in which the puncturing portion is inserted into the biological organ.

4. A biological organ closure device as described in any one of claims 1 to 3, which has a balloon member that can be expanded and contracted by supplying and discharging fluid, can be placed inside the deformation portion and is constructed separately from the deformation portion, and can expand the deformation portion by expanding while placed inside the deformation portion.

5. A biological organ closure device as described in any one of claims 1 to 3, wherein the deformation portion includes an elastic member provided on the outer surface.

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