Suture for use in flexible endoscopic surgeries

Abstract

Provided is a suture 100 for use in flexible endoscopic surgeries, which is provided with a suture main body part 10, one stopper member 30 that is arranged at the center of the direction of the length of the suture main body part 10, and a plurality of projecting parts 50 that obliquely project toward a direction opposed to the direction of the insertion of the suture main body part 10, in which the plurality of projecting parts 50 include a plurality of first projecting parts 51 which are arranged on one side with respect to the stopper member 30 in the direction of the length of the suture main body part 10 and which obliquely project toward the other side of the suture main body part 10 and the outside and a plurality of second projecting parts 52 which are arranged on the other side with respect to the stopper member 30 in the direction of the length of the suture main body part 10 and which obliquely project toward the one side of the suture main body part 10 and the outside.

Description

Flexible endoscopic surgical sutures

[0001] The present invention relates to a suture for flexible endoscopic surgery.

[0002] Endoscopic surgery is a procedure performed inside the human or animal body while viewing images of the inside of the body taken with a lens placed at the tip of an endoscope on a monitor. Compared to conventional surgery performed through laparotomy, endoscopic surgery tends to be able to reduce the opening area, which has the advantage of allowing patients to experience less pain after surgery and recover more quickly.

[0003] As an instrument used in conventional surgery, for example, Patent Document 1 discloses a suture, a suture system, and a suturing method that are used, in particular, to fixate a prosthetic device to tissue and more reliably and accurately hold the suture in place to minimize slippage of the suture and / or a pledget used in combination with the suture, a suturing system that simplifies surgical procedures and minimizes the possibility of surgical errors, and a surgical suture that can more easily pass through tissue and a sewing ring without causing damage. It also discloses that the stop is preferably incorporated to limit the mobility of the pledget and / or improve the performance of the suture.

[0004] Meanwhile, endoscopic surgery can be divided into rigid endoscopic surgery and flexible endoscopic surgery. Rigid endoscopic surgery involves drilling multiple small holes on the surface of a patient's body and inserting a rigid endoscope and multiple instruments through the holes to perform surgery inside the patient's body. Flexible endoscopic surgery involves performing surgery inside the patient's body using instruments inserted and removed through forceps channels located at the tip of the flexible endoscope while checking images captured by a lens located at the tip of the flexible endoscope.

[0005] As an example of an instrument used in endoscopic surgery, Patent Document 2 discloses a suture for endoscopic surgery, which is composed of a first portion extending a predetermined length from one end and a second portion excluding the first portion, the first portion and the second portion being different colors, and describes that it is possible to provide a suture that allows for easy suturing in endoscopic surgery.

[0006] JP-T-2013-502990A JP-A-2015-58110A

[0007] The surgical suture described in Patent Document 1 is not intended for, nor is it optimized for, surgery inside a patient's body (e.g., the intestinal tract) using a rigid or flexible endoscope. Furthermore, flexible endoscopic surgery involves performing surgery on a patient's affected area using only instruments inserted and removed through forceps holes at the tip of the flexible endoscope. Conventional sutures used in flexible endoscopic surgery (e.g., the suture described in Patent Document 2) are generally designed to suture only the surface layer, such as the mucosal layer of the stomach and intestines. Therefore, when attempting to close an opening, for example, created by an incision in human or animal tissue, using a conventional flexible endoscopic surgical suture, it is difficult to continue inserting the flexible endoscopic surgical suture so that the edge of the opening faces the inside of the opening (the direction normally visible through the lens of the flexible endoscope), making it difficult to completely close the opening.

[0008] Furthermore, flexible endoscopic surgery is different from general surgery that does not use an endoscope or surgery using a rigid endoscope in that it is difficult to suture the affected area while grasping and pressing it, etc. Therefore, flexible endoscopic surgery has the problem that it tends to take a long time to suture.

[0009] The problem to be solved by the present invention is to provide a flexible suture for endoscopic surgery that can easily and completely close an opening in human or animal tissue and can shorten the suturing time.

[0010] The present inventors have found that the above problems can be solved by adopting the following configuration, and have completed the invention.

[0011] That is, the present invention is as follows: <1> A flexible suture for use in endoscopic surgery for suturing up an opening in human or animal tissue, comprising a suture main body, a stop member located in the longitudinal center of the suture main body and preventing the suture main body from slipping out, and a plurality of protrusions protruding obliquely in a direction opposite to the insertion direction of the suture main body, the plurality of protrusions comprising: a plurality of first protrusions located on one side of the stop member in the longitudinal direction of the suture main body and protruding obliquely toward the other side and outward of the suture main body, and a plurality of second protrusions located on the other side of the stop member in the longitudinal direction of the suture main body and protruding obliquely toward the one side and outward of the suture main body. <2> A flexible suture for use in endoscopic surgery according to <1> above, wherein both ends of the suture main body are inserted from the outer wall side to the inner wall side of the tissue near the opening. <3> The suture for flexible endoscopic surgery according to <1> or <2> above, wherein one end of the suture main body is inserted from the outer wall side to the inner wall side of tissue near the opening where the diameter of the opening is largest, and the other end of the suture main body is inserted from the outer wall side to the inner wall side of tissue located on the opposite side of the opening from the tissue into which one end of the suture main body is inserted. <4> The suture for flexible endoscopic surgery according to any one of <1> to <3> above, wherein the stopper member cooperates with the multiple protrusions to hold the opening in a narrowed state on the outer wall side. <5> The suture for flexible endoscopic surgery according to any one of <1> to <4> above, wherein the suture main body comprises a first suture piece having the multiple protrusions and a second suture piece having the multiple protrusions, and the stopper member is disposed at a joint between the first suture piece and the second suture piece. <6> The suture for flexible endoscopic surgery according to any one of <1> to <5> above, wherein the stopper member has a spherical shape. <7> The suture for flexible endoscopic surgery according to any one of <1> to <5> above, wherein the stopper member is plate-shaped. <8> The suture for flexible endoscopic surgery according to any one of <1> to <5> above, wherein the stopper member has a coil shape.<9> The suture for flexible endoscopic surgery according to <1> to <5> above, wherein the fastening member is a knot tying the suture body. <10> The suture for flexible endoscopic surgery according to any one of <1> to <5> above, wherein the fastening member is a clip capable of clamping the suture body. <11> The suture for flexible endoscopic surgery according to any one of <1> to <10> above, which is made of a bioabsorbable material. <12> A suturing unit for flexible endoscopic surgery using the suture for flexible endoscopic surgery according to any one of <1> to <11> above, which has needles on both ends of the suture body.

[0012] According to the present invention, it is possible to provide a flexible suture for endoscopic surgery that can easily and completely close an opening in human or animal tissue and can shorten the suturing time.

[0013] 1. A diagram for explaining a configuration example of a suture for flexible endoscopic surgery according to a first embodiment. It is a partial enlarged view of the suture for flexible endoscopic surgery according to the first embodiment, where sub-view (a) in the diagram is a partial enlarged view of a portion indicated by reference symbol A in FIG. 1, and sub-view (b) in the diagram is a partial enlarged view of a portion indicated by reference symbol B in FIG. 1. It is a diagram for explaining a state in which one end of the suture for flexible endoscopic surgery according to the first embodiment is inserted from the outer wall side to the inner wall side of tissue near an opening. It is a diagram for explaining a state in which one end of the suture for flexible endoscopic surgery according to the first embodiment is inserted from the outer wall side to the inner wall side of tissue near an opening, and then the other end of the suture for flexible endoscopic surgery according to the first embodiment is inserted from the outer wall side to the inner wall side into tissue located on the opposite side of the opening from the tissue into which the one end of the suture for flexible endoscopic surgery was inserted. It is a diagram for explaining a state after both ends of the suture for flexible endoscopic surgery according to the first embodiment have been inserted from the outer wall side to the inner wall side of tissue near an opening. 1 is a cross-sectional view illustrating a state in which both ends of a suture for flexible endoscopic surgery according to a first embodiment have been inserted from the outer wall side to the inner wall side of tissue near an opening, and then further tension has been applied from one side of the suture for flexible endoscopic surgery. FIG. 1 is a cross-sectional view illustrating a state in which both ends of a suture for flexible endoscopic surgery according to the first embodiment have been inserted from the outer wall side to the inner wall side of tissue near an opening, and tension has been applied from one side to insert one end of the suture for flexible endoscopic surgery into the raised tissue. FIG. 2 is a cross-sectional view illustrating a state in which suturing of an opening has been completed with the suture for flexible endoscopic surgery according to the first embodiment. FIG. 3 is a view illustrating an example of the configuration of a suture for flexible endoscopic surgery according to a second embodiment. FIG. 4 is a view showing an example of a manufacturing method of a suture for flexible endoscopic surgery according to the second embodiment, in which part (a) in the figure is a view illustrating the configuration of a first suture piece and a second suture piece, and part (b) in the figure is a view illustrating a state in which the first suture piece and the second suture piece have been joined. FIG. 10 shows an example of another manufacturing method for a suture for flexible endoscopic surgery according to the second embodiment, in which (a) illustrates a state in which a second suture piece is inserted into the large diameter portion of a first suture piece and the first suture is inserted into the large diameter portion of the second suture piece, and (b) illustrates a state in which the large diameter portion of the first suture piece and the large diameter portion of the second suture piece are joined together.10A and 10B are diagrams for explaining a stopper member according to a modified example, in which (a) is a diagram for explaining an example of the configuration of a stopper member according to a modified example, and (b) is a cross-sectional view for explaining a state in which both ends of the suture main body are inserted from the outer wall side to the inner wall side of the tissue near the opening and then further tension is applied from one side of the suture main body. 10B are diagrams for explaining an example of the configuration of a stopper member according to a modified example. 10C are diagrams for explaining an example of the configuration of a first suture piece and a second suture piece according to a modified example.

[0014] Preferred embodiments for carrying out the present invention will be described below with reference to the drawings. Note that the following embodiments do not limit the inventions according to the claims, and not all of the combinations of features described in the embodiments are essential to the solution of the invention.

[0015] First, a configuration example of a suture 100 for flexible endoscopic surgery according to a first embodiment will be described with reference to Figures 1 and 2. Here, Figure 1 is a diagram for explaining the configuration example of the suture for flexible endoscopic surgery according to the first embodiment. Figure 2 is a partial enlarged view of the suture for flexible endoscopic surgery according to the first embodiment, with sub-view (a) in Figure 2 being a partial enlarged view of the portion indicated by reference character A in Figure 1, and sub-view (b) in Figure 2 being a partial enlarged view of the portion indicated by reference character B in Figure 1.

[0016] 1 and 2 , a flexible endoscopic surgery suture 100 according to a first embodiment is used to suture openings in human or animal tissue, and comprises a suture main body 10, a retaining member 30 that is located in the center of the length of the suture main body 10 and prevents the suture main body 10 from slipping out, and a plurality of protrusions 50 that protrude obliquely in the direction opposite to the insertion direction of the suture main body 10 (counter-insertion direction). The plurality of protrusions 50 are comprised of a plurality of first protrusions 51 that are located on one side of the retaining member 30 in the length direction of the suture main body 10 and protrude obliquely toward the other side and outward of the suture main body 10, and a plurality of second protrusions 52 that are located on the other side of the retaining member 30 in the length direction of the suture main body 10 and protrude obliquely toward the one side and outward of the suture main body 10.

[0017] In this specification, an opening in human or animal tissue (hereinafter simply referred to as an opening) refers to a part in the tissue inside the human or animal body that is open and is the target for suturing, and there are no particular limitations on the shape, size, etc., but generally, under a flexible endoscope, it often refers to an opening in the inner wall of the digestive tract.

[0018] As shown in Figure 1, the suture body 10 is the main body of the suture 100 for flexible endoscopic surgery. The suture body 10 may be composed of a single thread, or may be composed of a combination of two threads as described below. The suture body 10 may also be composed of multiple overlapping threads, such as a double-layered thread. In addition to the suture body 10, the components constituting the suture 100 for flexible endoscopic surgery are preferably made of bioabsorbable materials that do not require removal and do not leave any foreign matter behind. Examples of bioabsorbable materials include polyglycolic acid, polylactic acid, polydioxane, polycaprolactone, glycolic acid / lactic acid polyester, etc.

[0019] The length of the suture body 10 (flexible endoscopic surgical suture 100) can be changed appropriately depending on the size of the opening, etc., and is not particularly limited, but can be, for example, 10 cm or more, 13 cm or more, 15 cm or more, or 25 cm or less.

[0020] The thickness of the suture body 10 can also be changed appropriately depending on the thickness of the tissue near the opening, and is not particularly limited, but can be, for example, 0.15 mm or more, 0.20 mm or more, 0.30 mm or more, 0.35 mm or more, and 0.70 mm or less.

[0021] The thickness of the suture main body 10 may or may not be constant. If the thickness of the suture main body 10 is not constant, for example, the thickness of the suture main body 10 near the stopper member 30 (described below) and at the center in the longitudinal direction of the suture main body 10 can be made thicker than the thickness of the other portions of the suture main body 10. This configuration makes it easier to prevent loosening of the suture main body 10 (flexible suture 100 for endoscopic surgery).

[0022] 1, a single retaining member 30 that prevents the suture body 10 from slipping out is disposed in the center of the length of the suture body 10. Note that the center of the length of the suture body 10 includes not only the position at 1 / 2 of the length of the suture body 10 but also the region located at 2 / 5 to 3 / 5 of the length of the suture body 10.

[0023] When each of the ends of the suture body 10 (suture 100 for flexible endoscopic surgery) is inserted from the outer wall side to the inner wall side of the tissue near the opening, the retaining member 30 functions to prevent the suture body 10 (suture 100 for flexible endoscopic surgery) from slipping out on the outer wall side of the tissue.

[0024] Conventionally, endoscopic surgical sutures have been provided with a knot or the like at one end to prevent the suture from slipping out. Conventional endoscopic surgical sutures require that the end of the suture, which does not have a knot or other such prevention feature, be first inserted from the serosa or adventitia side, which is the outer wall side, of the gastrointestinal tract, to the inner wall side, and then inserted from the inner wall side to the serosa or adventitia side, which is the outer wall side. Because other organs, etc., are located outside the serosa or adventitia (the side opposite to the direction normally visible through the lens of a flexible endoscope), suturing using conventional endoscopic surgical sutures requires careful attention not to injure the other organs, etc. However, the flexible suture 100 for endoscopic surgery according to this embodiment has one stop member 30 located in the longitudinal center of the suture body 10, so that each end of the suture body 10 (the suture 100 for flexible endoscopic surgery) can be inserted near the opening from the serous membrane or adventitia side, which is the outer wall side of the gastrointestinal tract, to the inner wall side of the gastrointestinal tract, etc., making it easier to prevent damage to other organs, etc. As a result, the flexible suture 100 for endoscopic surgery according to this embodiment can shorten the time required to suture an opening.

[0025] Furthermore, according to the present invention, when inserting each of the ends of the suture body 10 (suture 100 for flexible endoscopic surgery), the tips of both ends of the suture body 10 (suture 100 for flexible endoscopic surgery) can be confirmed in the image captured by the lens located at the tip of the flexible endoscope, which provides excellent safety.

[0026] The retaining member 30 is not particularly limited as long as it is thicker than the suture body 10 and functions to prevent the suture body 10 from slipping out, but for example, it can be made to be three times or more in size (thickness) than the thickness of the suture body 10.

[0027] The shape of the retaining member 30 is not particularly limited as long as it functions to prevent the suture main body 10 from slipping out, and may be spherical, elliptical, hemispherical, semi-elliptical, polygonal, cylindrical, polygonal prism, cylindrical, or polygonal tube. As will be described later, the retaining member 30 may be loop-shaped, plate-shaped, or coil-shaped. It may also be a knot that ties the suture main body 10, or a clip that can clamp the suture main body 10. Furthermore, as will be described later, when the suture main body 10 is composed of two suture pieces, the portion where the two suture pieces are joined may serve as the retaining member 30.

[0028] The stopper member 30 is not particularly limited, but for example, the maximum width perpendicular to the longitudinal direction of the suture body 10 can be greater than the maximum width parallel to the longitudinal direction of the suture body 10. With this configuration, the stopper member 30 can easily penetrate between the serosa or adventitia of the tissue near the opening, keeping the opening in a narrowed state, and making it easier for the tissue near the opening to bulge inward (towards the inner wall). In the stopper member 30, the ratio of the maximum width perpendicular to the longitudinal direction of the suture body 10 to the maximum width parallel to the longitudinal direction of the suture body 10 (maximum width perpendicular to the longitudinal direction: maximum width parallel to the longitudinal direction) can be, for example, 1:1, 2:1, 3:1, 4:1, 5:1, 6:1, 7:1, 8:1, 9:1, 10:1, 12:1, 15:1, 20:1, 25:1, 30:1, 40:1, 50:1, 60:1, or 70:1. That is, in the stopper member 30, the ratio of the maximum width perpendicular to the longitudinal direction of the suture body 10 to the maximum width parallel to the longitudinal direction of the suture body 10 can be, for example, 1:1 to 70:1, 2:1 to 60:1, or 3:1 to 50:1.

[0029] When the flexible endoscopic surgical suture 100 according to this embodiment is used, for example, for full-thickness suturing of the digestive tract, the maximum width of the stopper member 30 perpendicular to the longitudinal direction of the suture body 10 is selected appropriately according to the thickness of the suture body 10, and can be, for example, 0.15 mm or more, 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, 0.45 mm or more, 3 mm or less, 2.5 mm or less, 2 mm or less, 1.5 mm or less, or 1 mm or less.

[0030] In the above case, the maximum width of the retaining member 30 parallel to the longitudinal direction of the suture body 10 is not particularly limited, but can be, for example, 0.15 mm or more, 0.2 mm or more, 0.3 mm or more, 0.4 mm or more, 0.45 mm or more, 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, 6 mm or less, 5 mm or less, 4 mm or less, 3 mm or less, 2.5 mm or less, 2 mm or less, 1.5 mm or less, or 1 mm or less.

[0031] When the flexible suture 100 for endoscopic surgery according to this embodiment is used, for example, for full-thickness suturing of the digestive tract, the above-described configuration allows the stopper member 30 to easily penetrate between the serosa or adventitia of the tissue near the opening of the digestive tract, thereby holding the opening in a narrowed state and urging the tissue near the opening to bulge inward (toward the inner wall), thereby enabling the suture body 10 to be inserted into the bulged tissue, thereby enabling the digestive tract opening to be easily and completely closed across all layers in a short period of time. Furthermore, when the stopper member 30 (e.g., a plate-like member, as described below) is formed so that its maximum width perpendicular to the longitudinal direction of the suture body 10 is greater than its maximum width parallel to the longitudinal direction of the suture body 10, the stopper member 30 is easily urged to bulge inward (toward the inner wall) along the surface of the stopper member 30 that is approximately perpendicular to the longitudinal direction of the suture body 10 (toward the bulging state), thereby shortening the suturing time.

[0032] As shown in Fig. 1, the stopper member 30 according to this embodiment has a spherical shape. As a result of the stopper member 30 having a spherical shape, as will be described later, when both ends of the suture body 10 (flexible suture for endoscopic surgery) are inserted from the outer wall side to the inner wall side of the tissue near the opening and further tension is applied from one side of the suture body 10 (flexible suture for endoscopic surgery 100), the stopper member 30 can easily penetrate between the serosa or adventitia of the tissue near the opening, thereby keeping the opening in a narrowed state and easily causing the tissue near the opening to bulge inward (toward the inner wall), allowing the bulged tissue portion to be the target for insertion of the suture body 10, thereby shortening the time required to suture the opening (see Fig. 6). Furthermore, when multiple sutures 100 for flexible endoscopic surgery are stored in a general container, the retaining member 30 has no corners and is less likely to get caught on other sutures for flexible endoscopic surgery, and as a result, the multiple sutures 100 for flexible endoscopic surgery are less likely to become tangled with each other.

[0033] 2, the suture main body 10 is configured with a plurality of protrusions 50 that protrude obliquely in the direction opposite to the insertion direction of the suture main body 10 (suture 100 for flexible endoscopic surgery). By providing a plurality of protrusions 50 that protrude obliquely in the direction opposite to the insertion direction of the suture main body 10 (suture 100 for flexible endoscopic surgery), it is possible to prevent the suture main body 10 (suture 100 for flexible endoscopic surgery) that has been inserted into tissue near an opening from moving in the counter-insertion direction, i.e., the direction opposite to the insertion direction, or from slipping out.

[0034] The number of multiple protrusions 50 is not particularly limited as long as it can prevent the suture main body 10 (flexible endoscopic surgical suture 100) inserted into the tissue near the opening from moving in the direction opposite to insertion or slipping out, and can be changed as appropriate.

[0035] The multiple protrusions 50 may be arranged at equal intervals or at non-equidistant intervals. If the multiple protrusions 50 are not arranged at equal intervals along the length of the suture body 10, for example, the spacing between the protrusions 50 near the stop member 30 and at the center of the length of the suture body 10 can be narrower than the spacing between the protrusions in other parts of the suture body 10. This configuration makes it easier to prevent the suture body 10 (flexible suture 100 for endoscopic surgery) from loosening.

[0036] The inclination angle of the multiple protrusions 50 is not particularly limited as long as it can prevent the suture main body 10 (flexible endoscopic surgical suture 100) inserted into the tissue near the opening from moving in the direction opposite to the insertion or slipping out, and can be changed appropriately depending on the thickness of the tissue near the opening, etc., but can be, for example, 15° or less relative to the suture main body 10.

[0037] The length of the multiple protrusions 50 is not particularly limited as long as it can prevent the suture main body 10 (flexible endoscopic surgical suture 100) inserted into the tissue near the opening from moving in the direction opposite to the insertion or slipping out, and can be changed appropriately depending on the thickness of the tissue near the opening, etc., but can be, for example, 1 / 3 or more of the thickness of the suture main body 10.

[0038] The thickness of the multiple protrusions 50 is not particularly limited as long as it can prevent the suture main body 10 (flexible endoscopic surgical suture 100) inserted into the tissue near the opening from moving in the opposite direction to the insertion or slipping out, and can be changed appropriately depending on the thickness of the tissue near the opening, etc.

[0039] The multiple protrusions 50 are configured to include multiple first protrusions 51 that are arranged on one side of the stopper member 30 in the longitudinal direction of the suture body 10 and protrude obliquely toward the other side and outward of the suture body 10, and multiple second protrusions 52 that are arranged on the other side of the suture body 10 in the longitudinal direction of the suture body 10 and protrude obliquely toward the one side and outward of the suture body 10 (see Figures 1 and 2).

[0040] As shown in the partial view (a) of Fig. 2, in the longitudinal direction of the suture body 10, the plurality of first protrusions 51 arranged on the left side of the paper in Fig. 1 with respect to the stop member 30 are configured to protrude obliquely in the counter-insertion direction (the right side of the paper in Fig. 1) and toward the outside of the suture body 10 (the upper or lower side of the paper in Figs. 1 and 2) (see Fig. 1). As shown in the partial view (b) of Fig. 2, the plurality of second protrusions 52 arranged on the right side of the paper in Fig. 1 with respect to the stop member 30 are configured to protrude obliquely in the counter-insertion direction (the left side of the paper in Fig. 1) and toward the outside of the suture body 10 (the upper or lower side of the paper in Figs. 1 and 2) (see Fig. 1).

[0041] Because the flexible endoscopic surgical suture 100 is provided with the first protrusion 51 and the second protrusion 52, each of the two ends of the suture main body 10 (flexible endoscopic surgical suture 100) can be smoothly inserted from the outer wall side to the inner wall side of the tissue near the opening, and the suture main body 10 (flexible endoscopic surgical suture 100) can be prevented from moving in the direction opposite to the insertion or from slipping out.

[0042] More specifically, one end of the suture main body 10 (suture 100 for flexible endoscopic surgery) can be smoothly inserted from the outer wall to the inner wall of tissue near the location where the opening diameter is largest (see FIG. 3 ), and the other end of the suture main body 10 (suture 100 for flexible endoscopic surgery) can be smoothly inserted from the outer wall to the inner wall of tissue near the location where the opening diameter is largest, on the opposite side from the location where the one end of the suture main body 10 (suture 100 for flexible endoscopic surgery) is inserted (see FIG. 4 ). This prevents the inserted suture main body 10 (suture 100 for flexible endoscopic surgery) from moving in the counter-insertion direction or slipping out. Therefore, as described above, it is easier to prevent damage to external organs, etc. As a result, the flexible suture 100 for flexible endoscopic surgery according to this embodiment can shorten the time required to suture an opening. Furthermore, the image captured by the lens located at the tip of the flexible endoscope allows the tips of one end and the other end of the suture main body 10 (flexible endoscopic surgical suture 100) to be confirmed, providing excellent safety.

[0043] An example of the configuration of the suture 100 for flexible endoscopic surgery according to the first embodiment has been described above. Next, a method of using the suture 100 for flexible endoscopic surgery according to the first embodiment will be described with reference to FIGS. 3 to 8 . Here, FIG. 3 is a diagram illustrating a state in which one end of the suture for flexible endoscopic surgery according to the first embodiment has been inserted from the outer wall side to the inner wall side of tissue near an opening. FIG. 4 is a diagram illustrating a state in which one end of the suture for flexible endoscopic surgery according to the first embodiment has been inserted from the outer wall side to the inner wall side of tissue near an opening, and then the other end of the suture for flexible endoscopic surgery according to the first embodiment has been inserted from the outer wall side to the inner wall side near tissue located on the opposite side of the opening from the tissue into which the one end of the suture for flexible endoscopic surgery was inserted. FIG. 5 is a diagram illustrating a state after both ends of the suture for flexible endoscopic surgery according to the first embodiment have been inserted from the outer wall side to the inner wall side of tissue near an opening. Fig. 6 is a cross-sectional view illustrating a state in which both ends of the flexible endoscopic surgical suture according to the first embodiment have been inserted from the outer wall side to the inner wall side of the tissue near the opening, and further tension has been applied to one side of the flexible endoscopic surgical suture. Fig. 7 is a cross-sectional view illustrating a state in which both ends of the flexible endoscopic surgical suture according to the first embodiment have been inserted from the outer wall side to the inner wall side of the tissue near the opening, and tension has been applied from one side to insert one end of the flexible endoscopic surgical suture into the raised tissue. Fig. 8 is a view illustrating a state in which suturing of the opening has been completed with the flexible endoscopic surgical suture according to the first embodiment. Note that for ease of explanation, the sizes of the multiple protrusions 50 (51, 52) are exaggerated in Figs. 3 to 8.

[0044] In order to suture the opening OP with the suture thread 100 for flexible endoscopic surgery according to the first embodiment, a grasper T can be used to grasp the suture thread 100 for flexible endoscopic surgery, as shown in Fig. 3. The grasper T is not particularly limited as long as it can be inserted and removed through a forceps hole located at the tip of the flexible endoscope and can grasp the suture thread 100 for flexible endoscopic surgery (or a needle provided in a suturing unit for flexible endoscopic surgery, which will be described later).

[0045] With the flexible endoscopic surgical suture 100, one end of the suture body 10 (flexible endoscopic surgical suture 100) can be inserted, for example, from the outer wall side to the inner wall side of the stomach or intestines into tissue near the location where the opening diameter of the opening OP is largest, while the suture body 10 (flexible endoscopic surgical suture 100) on one side relative to the stop member 30 is grasped with a grasper T (see FIG. 3). At this time, as shown in FIG. 3, the suture body 10 (flexible endoscopic surgical suture 100) on one side relative to the stop member 30 is configured with multiple protrusions 50 (51), which prevents the suture body 10 (flexible endoscopic surgical suture 100) from moving in the counter-insertion direction or slipping out. Therefore, according to the present invention, the operation of inserting the suture body 10 (suture 100 for flexible endoscopic surgery) into the tissue near the opening OP can be smoothly carried out, which leads to a reduction in the suturing time. Note that, although the insertion of the suture body 10 (suture 100 for flexible endoscopic surgery) is started from the tissue near the opening OP on the left side of the page in Figure 3, the insertion of the suture body 10 (suture 100 for flexible endoscopic surgery) may also start from the tissue near the opening OP on the right side of the page in Figure 3, and the order is not particularly limited.

[0046] Next, as shown in FIG. 4, with the suture body 10 (suture 100 for flexible endoscopic surgery) on the other side relative to the stopper member 30, the other end of the suture body 10 (suture 100 for flexible endoscopic surgery) can be grasped with a grasper T, and the other end of the suture body 10 (suture 100 for flexible endoscopic surgery) can be inserted from the outer wall side to the inner wall side of the stomach and intestines or the like into tissue located on the opposite side of the tissue of the opening OP into which one end of the suture body 10 (suture 100 for flexible endoscopic surgery) has been inserted. The suture body 10 (suture 100 for flexible endoscopic surgery) on the other side of the stop member 30 is configured with a plurality of protrusions 50 (52), so that when the suture body 10 (suture 100 for flexible endoscopic surgery) is inserted into tissue near the opening OP, the suture body 10 (suture 100 for flexible endoscopic surgery) can be prevented from moving in the counter-insertion direction or slipping out. Therefore, according to the present invention, the suture body 10 (suture 100 for flexible endoscopic surgery) can be smoothly inserted into tissue near the opening OP, which leads to a reduction in suturing time.

[0047] In the flexible endoscopic surgical suture 100 according to this embodiment, when both ends of the suture body 10 (flexible endoscopic surgical suture 100) are inserted from the outer wall side to the inner wall side of the stomach, intestines, etc., and tension is applied to the inserted suture body 10 (flexible endoscopic surgical suture 100), the retaining member 30 and the multiple protrusions 50 (51, 52) work together to restrict movement of the inserted suture body 10 (flexible endoscopic surgical suture 100) in the direction opposite to the insertion direction and to prevent the inserted suture body 10 (flexible endoscopic surgical suture 100) from slipping out, so that the opening OP can be held in a narrowed state, as shown in FIG. 5 .

[0048] When further tension is applied by pulling one side of the suture body 10 (suture 100 for flexible endoscopic surgery) from the state shown in Figure 5, the retaining member 30 cooperates with the multiple protrusions 50 (51, 52) to hold the opening OP in a narrowed state on the outer wall side, and the tissue near the opening OP can be caused to bulge inward (toward the inner wall, i.e., in the direction normally visible through the lens of the flexible endoscope), as shown in Figure 6.

[0049] Once both ends of the suture body 10 (suture 100 for flexible endoscopic surgery) are inserted into the tissue near the opening OP and the tissue near the opening OP is raised, both ends of the suture body 10 (suture 100 for flexible endoscopic surgery) can be inserted into the raised tissue portion, as shown in Fig. 7 . More specifically, when the suture body 10 (suture 100 for flexible endoscopic surgery) is inserted into the raised tissue portion near the opening OP, there is little risk of damaging other organs, etc., so the suture body 10 (suture 100 for flexible endoscopic surgery) can be inserted from the inner wall of the stomach, intestines, etc., through the outer wall, and to the inner wall on the opposite side in one go (or all at once). This allows the suture body 10 (suture 100 for flexible endoscopic surgery) to be easily inserted into all layers of the stomach, intestines, etc.

[0050] Inserting the suture main body 10 (suture 100 for flexible endoscopic surgery) into tissue near a raised opening OP is easier than inserting the suture main body 10 (suture 100 for flexible endoscopic surgery) into tissue near a narrowed opening OP because there is less movement of the grasper T and the suture 100 for flexible endoscopic surgery grasped by the grasper T, allowing for continuous insertion, and because it can be operated within the range displayed in the image captured by the lens installed at the tip of the flexible endoscope. Therefore, the suture 100 for flexible endoscopic surgery according to this embodiment can shorten the time required to suture the opening OP.

[0051] Then, by inserting each end of the suture main body 10 (flexible suture for endoscopic surgery 100) into the tissue near the raised opening OP several times, suturing of the opening OP is completed as shown in Figure 8. In this way, the flexible suture for endoscopic surgery 100 according to this embodiment makes it possible to easily and completely close the opening OP.

[0052] The flexible endoscopic surgical suture 100 according to this embodiment is configured such that one end of the suture body 10 is inserted from the outer wall to the inner wall of the tissue near an opening OP in human or animal tissue, for example, near the opening OP with the largest diameter, and the other end of the suture body 10 is inserted from the outer wall to the inner wall of the tissue on the opposite side of the opening OP from where the one end of the suture body 10 was inserted. Then, by applying tension, the stopper member 30 cooperates with the multiple protrusions 50 (51, 52) to hold the opening constricted on the outer wall, and the tissue near the opening OP is raised inward (toward the inner wall, i.e., in the direction normally visible through the lens of the flexible endoscope), allowing both ends of the suture body 10 to be inserted continuously into the raised portion (full-thickness continuous suture). Therefore, the flexible endoscopic surgical suture 100 according to this embodiment is suitable for use in suturing methods in flexible endoscopic surgery. This suturing method for flexible endoscopic surgery can more easily prevent damage to other external organs, etc., and as a result, it is possible to shorten the time required to suture the opening. Furthermore, since the distal ends of the suture main body 10 (suture 100 for flexible endoscopic surgery) can be confirmed in images captured by a lens located at the tip of the flexible endoscope, it is highly safe. In other words, the present invention also provides a suturing method for flexible endoscopic surgery using a suture for flexible endoscopic surgery or a suturing unit for flexible endoscopic surgery, which will be described later.

[0053] The suture 100 for flexible endoscopic surgery according to this embodiment has been described above. Next, a suture 120 for flexible endoscopic surgery according to a second embodiment will be described using Figs. 9 to 11 . Here, Fig. 9 is a diagram for explaining an example of the configuration of a suture for flexible endoscopic surgery according to the second embodiment. Fig. 10 is a diagram showing an example of a manufacturing method for a suture for flexible endoscopic surgery according to the second embodiment, with partial view (a) in Fig. 10 illustrating the configuration of a first suture piece and a second suture piece, and partial view (b) in Fig. 10 illustrating the state in which the first suture piece and the second suture piece are joined together. 11A and 11B are diagrams showing another example of a manufacturing method for a suture for flexible endoscopic surgery according to the second embodiment, in which (a) illustrates a state in which a second suture piece is inserted into the large diameter portion of a first suture piece and the first suture is inserted into the large diameter portion of the second suture piece, and (b) illustrates a state in which the large diameter portions of the first and second suture pieces are joined together. Note that components that are the same as or similar to those in the above-described embodiment will be assigned the same reference numerals and descriptions thereof will be omitted in some cases.

[0054] [Suture 120 for flexible endoscopic surgery according to a second embodiment] As shown in Figure 9, a suture 120 for flexible endoscopic surgery according to a second embodiment can be configured such that the suture body 10 comprises a first suture piece 11 having a plurality of protrusions 50 and a second suture piece 13 having a plurality of protrusions 50, and a stop member 30 is disposed at the joint between the first suture piece 11 and the second suture piece 13.

[0055] The suture body 10 according to this embodiment can be configured from a first suture piece 11 and a second suture piece 13. The method of joining the first suture piece 11 and the second suture piece 13 is not particularly limited.

[0056] As shown in the partial view (a) of Figure 10, the first suture piece 11 according to this embodiment is configured to have a first suture piece main body 12, a plurality of protrusions 50 (51), and a large diameter portion 21 at one end thereof that is thicker or larger in size than the first suture piece main body 12.

[0057] The large diameter portion 21 of the first suture piece 11 has a loop shape, but the shape is not particularly limited, and may have any of the shapes exemplified above as the shape of the retaining member 30. The thickness or size of the large diameter portion 21 of the first suture piece 11 is also not particularly limited, as long as it is larger than the first suture piece body 12 and serves to prevent the suture body 10 (flexible endoscopic surgical suture 120) from slipping out when joined to the second suture piece 13 to form the joined portion 31.

[0058] 10 (a), the second suture piece 13 according to this embodiment is configured to have a second suture piece main body 14, a plurality of protrusions 50 (52), and a large diameter portion 21 at one end of the second suture piece main body 14 that is thicker or larger in size than the second suture piece main body 14. As with the large diameter portion 21 of the first suture piece 11, the shape, thickness, size, etc. of the large diameter portion 21 of the second suture piece 13 are not particularly limited as long as they serve to prevent the suture main body 10 (flexible endoscopic surgery suture 120) from slipping out when joined to the first suture piece 11 to form the joined portion 31.

[0059] 10, in this embodiment, the large diameter portion 21 of the first suture piece 11 and the large diameter portion 21 of the second suture piece 13 are joined together to form the joining portion 31 and the fastening member 30. The method for joining the first suture piece 11 and the second suture piece 13 is not particularly limited, and they may be joined using an adhesive or the like.

[0060] Furthermore, since the large diameter portion 21 in this embodiment has a loop shape, as shown in the exploded view (a) of FIG. 11 , the second suture piece 13 may be inserted into the loop of the large diameter portion 21 of the first suture piece 11, and the first suture piece 11 may be inserted into the loop of the large diameter portion 21 of the second suture piece 13, thereby joining the first suture piece 11 and the second suture piece 13, and forming a retaining member 30 as shown in the exploded view (b) of FIG. 11 .

[0061] The retaining member 30 according to this embodiment is configured to have a loop shape, but as described above, the shape is not particularly limited.

[0062] In this way, the suture 120 for flexible endoscopic surgery according to this embodiment is formed by combining the two suture pieces 11, 13. When combining the two suture pieces 11, 13, the multiple protrusions 50 are arranged to protrude obliquely in the direction opposite to the insertion direction, as shown in Figures 9 to 11 .

[0063] The sutures 100, 120 for flexible endoscopic surgery according to the above-described embodiments can be used as a suture unit for flexible endoscopic surgery, in which needles are provided at both ends of the suture main body 10. In other words, the suture unit for flexible endoscopic surgery is formed by using the sutures 100, 120 for flexible endoscopic surgery, in which needles are provided at both ends of the suture main body 10.

[0064] The needles disposed at both ends of the suture body 10 may be those used in flexible endoscopic surgery and may, for example, have a curved shape. When the needles have a curved shape, the diameter of the needles may be changed appropriately depending on, for example, the thickness of the tissue near the opening, and may be at least twice the thickness of the tissue near the opening.

[0065] While the preferred embodiments of the present invention have been described above, the technical scope of the present invention is not limited to the scope described in the above embodiments. Various modifications and improvements can be made to the above embodiments.

[0066] For example, although the stopper member 30 is configured to have a spherical or loop shape in the above-described embodiment, it may be plate-shaped. The plate-shaped stopper member 30 can be manufactured, for example, by providing a through-hole in the center of the plate through which the suture body 10 is passed, and by passing the suture body 10 through the through-hole, or by integrally molding the suture body 10 and the stopper member 30.

[0067] The retaining member 30 may be, for example, as shown in the partial view (a) of Fig. 12 , a plate-like member having wall surfaces formed in a direction substantially perpendicular to the longitudinal direction of the suture main body 10 and end surfaces formed in a direction substantially parallel to the longitudinal direction of the suture main body 10, with the maximum width perpendicular to the longitudinal direction of the suture main body 10 being greater than the maximum width parallel to the longitudinal direction of the suture main body 10. With this configuration, as shown in the partial view (b) of Fig. 12 , the plate-like retaining member 30 can easily fit between the serosa or adventitia of the opening and cooperate with the multiple protrusions 50 (51, 52) to prevent the suture main body 10 from slipping out. Furthermore, the wall surfaces can easily cause the tissue near the opening to bend inward (toward the inner wall), thereby shortening the suturing time.

[0068] The stopper member 30 may be coil-shaped, as shown in the exploded view (a) of Fig. 13 . As shown in the exploded view (a) of Fig. 13 , the stopper member 30 having a coil shape can be formed, for example, by winding the suture main body 10 multiple times around the longitudinal center of the suture main body 10 and then joining the coil-shaped portion (stopper member 30) with, for example, an adhesive. Alternatively, the stopper member 30 can be manufactured by, for example, passing the suture main body 10 through a coil-shaped member made of a bioabsorbable material and joining the two together with, for example, an adhesive. Furthermore, for example, the stopper member 30 may be coiled by winding another suture main body 10 multiple times around the suture main body 10, in which case, for example, another suture main body 10 wound multiple times can be joined with, for example, an adhesive.

[0069] Furthermore, for example, the stopper member 30 may be a knot formed by tying the suture body 10 .

[0070] Furthermore, for example, the fastening member 30 may be a clip capable of clamping the suture body 10, as shown in the partial view (b) of Fig. 13. As shown in the partial view (b) of Fig. 13, the fastening member 30 may be formed by clamping one suture body 10 with the clip, or as shown in the partial view (c) of Fig. 13, the fastening member 30 may be formed by simultaneously clamping two suture pieces 11, 13. The clip that clamps the suture body 10 (suture pieces 11, 13) may be made of a bioabsorbable material.

[0071] In the above-described embodiment, the large diameter portion 21 of the first suture piece 11 and the large diameter portion 21 of the second suture piece 13 are configured to have a single loop shape, but for example, as shown in Fig. 14, the large diameter portion 21 may be configured by winding the ends of the first suture piece 11 (first suture piece body portion 12) and the second suture piece 13 (second suture piece body portion 14) that are not to be inserted into human or animal tissue into a loop (coil) shape. In this case, the ends of the first suture piece 11 (first suture piece body portion 12) and the second suture piece 13 (second suture piece body portion 14) can be configured to be arranged in the loop (coil) shape. With this configuration, the ends of the first suture piece 11 (first suture piece body portion 12) and the second suture piece 13 (second suture piece body portion 14) can form protruding portions 50 (51, 52) closer to the large diameter portion 21 than when they are arranged in the first suture piece 11 (first suture piece body portion 12) and the second suture piece 13 (second suture piece body portion 14). As with the above-described embodiment, the first suture piece 11 and the second suture piece 13 can be used to form a stopper member 30 by joining the large diameter portion 21 of the first suture piece 11 and the large diameter portion 21 of the second suture piece using, for example, an adhesive or the like, with the large diameter portions 21, 21 serving as joining portions (see FIG. 10 ). Alternatively, the first suture piece 11 and the second suture piece 13 may be joined by inserting the second suture piece 13 into the loop of the large diameter portion 21 of the first suture piece 11 and then inserting the first suture piece 11 into the loop of the large diameter portion 21 of the second suture piece 13, with the large diameter portions 21, 21 serving as joining parts to form a retaining member 30 (see FIG. 11).

[0072] Furthermore, the first suture piece main body portion 12 and the second suture piece main body portion 14 may be made of a single thread, as with the suture body portion 10, or may be made of multiple overlapping threads, such as doubled threads.

[0073] 100, 120: Flexible suture for endoscopic surgery, 10: Suture body, 11: First suture piece, 12: First suture piece body, 13: Second suture piece, 14: Second suture piece body, 21: Large diameter portion, 30: Stop member, 31: Joint portion, 50 (51, 52): Protrusion, 51: First protrusion, 52: Second protrusion, OP: Opening.

Claims

1. A flexible endoscopic surgical suture for suturing openings in human or animal tissue, The main body of the suture thread, A fastening member is positioned in the center of the suture body in the longitudinal direction and serves to prevent the suture body from coming loose. Multiple protrusions that project diagonally toward the opposite direction from the insertion direction of the suture body, Equipped with, The plurality of protrusions are, In the longitudinal direction of the suture body, a plurality of first protrusions are arranged on one side with respect to the fastening member and project diagonally toward the other side and outward toward the other side of the suture body, In the longitudinal direction of the suture body, a plurality of second protrusions are arranged on the other side with respect to the fastening member, and protrude diagonally toward one side and outward toward the suture body, A flexible endoscopic surgical suture equipped with [specific features / features].

2. The flexible endoscopic surgical suture according to claim 1, wherein both ends of the suture body are inserted from the outer wall side to the inner wall side of the tissue near the opening.

3. The flexible endoscopic surgical suture according to claim 1, wherein one end of the suture body is inserted from the outer wall side to the inner wall side of the tissue near the opening where the opening diameter of the opening is largest, and the other end of the suture body is inserted from the outer wall side to the inner wall side of the tissue located on the opposite side of the tissue from the opening into which one end of the suture body is inserted.

4. The fastening member cooperates with the plurality of protrusions to hold the opening in a constricted state on the outer wall side, as described in claim 1.

5. The suture body portion consists of a first suture piece having the plurality of protrusions and a second suture piece having the plurality of protrusions. The flexible endoscopic surgical suture according to claim 1, wherein the fastening member is positioned at the joint between the first suture piece and the second suture piece.

6. The fastening member is spherical, as described in claim 1, for flexible endoscopic surgical sutures.

7. The fastening member is plate-shaped, having a wall surface formed in a direction perpendicular to the longitudinal direction of the suture body and an end surface formed in a direction parallel to the longitudinal direction of the suture body, and the maximum width perpendicular to the longitudinal direction of the suture body is greater than the maximum width parallel to the longitudinal direction of the suture body, as described in claim 1.

8. The fastening member has a coil shape, as described in claim 1 for flexible endoscopic surgical sutures.

9. The fastening member is a knot that connects the main body of the suture, as described in claim 1.

10. The fastening member is a clip capable of gripping the suture body portion, as described in claim 1.

11. A flexible endoscopic surgical suture according to claim 1, made of a bioabsorbable material.

12. A flexible endoscopic surgical suture unit comprising a flexible endoscopic surgical suture according to any one of claims 1 to 11, wherein needles are provided at both ends of the suture body portion.