Auxiliary device to facilitate the placement of ligation instruments into target organs.

Abstract

The present invention provides a ligating device having a first jaw part that has a distal end and a proximal end, a second jaw part that has a distal end and a proximal end, and a lock mechanism, the first jaw part and the second jaw part being linked so as to be capable of rotating about the respective proximal-end sides. The lock mechanism comprises a combination of a portion installed on the distal-end side of the first jaw part and a portion installed on the distal-end side of the second jaw part, and is configured so as to be: capable of linking the distal-end side of the first jaw part and the distal-end side of the second jaw part in a a manner enabling adjustment of the distance over which the inner surface of the first jaw part and the inner surface of the second jaw part hold a target organ therebetween; and capable, through the adjustment of said holding distance, of changing the force by which the target organ is clamped.

Description

Technical Field

[0001] The present invention relates to an auxiliary instrument for facilitating the placement of a ligation instrument on a target organ. More specifically, it relates to an auxiliary instrument for facilitating the placement of a ligation instrument so as to clamp a target organ with an appropriate force, a ligation instrument that can be placed on a target organ so as to clamp the target organ with an appropriate force, and a system for ligating a target organ including the above-mentioned auxiliary instrument and ligation instrument.

Background Art

[0002] Ligation is performed to draw and fix severed tissues due to trauma or the like, to occlude the lumen by binding around blood vessels or fallopian tubes, to bind and fix tissues so as to close the hernia gate or the like, or to bind up tissues to be removed, stop blood flow, and cause necrosis and exfoliation. Various instruments for performing ligation and auxiliary instruments for facilitating the placement of a ligation instrument on a target organ have been proposed.

[0003] For example, Patent Document 1 comprises a first arm, a second arm, and an elastic hinge connecting the first and second arms, with the first and second arms connected to the elastic hinge at their respective bases, the first arm having a convex outer surface and a concave inner surface for clamping the pancreas, the second arm having a convex or planar outer surface and a concave or planar inner surface for clamping the pancreas, the inner surfaces of the first arm and the second arm facing each other, and the tip of the first arm curves toward the second arm, forming a flexible hook portion. The present invention discloses a polymer surgical clip for pancreatic resection, wherein the first and second arms maintain substantially the same shape in the open and closed positions, and the inner surfaces of the first and second arms that clamp the pancreas are configured to create a space between them. The clip can be used with an applier, which has a scissor shape so that the clip can be set by clamping it between the two legs and opening the clip. The inner surfaces of the two legs are each provided with a locking mechanism, which engages with a projection on the clip to secure it.

[0004] Patent Document 2 discloses a clamping device having a distal end including first and second pressure-applying jaws with opposing lumen clip receiving surfaces, wherein a sensor is provided on at least one of the pressure-applying jaws to sense the position of one or more lumens, wherein a lumen clip is releasably fixed between the opposing lumen clip receiving surfaces, the position of the lumen is sensed using the sensor, and the pressure-applying jaws are closed to compress the lumen using the lumen clip, thereby at least partially closing the lumen.

[0005] Patent Document 4 discloses a clamping device for minimally invasive surgery, comprising: a) an elongated surface member having a base end and a tip end; b) a biocompatible variable shape placed on the tip end of the surface member; and c) a flexible band having a base end and a tip end, wherein the tip end of the flexible band is coupled to the tip end of the surface member, the flexible band and the biocompatible variable shape on the surface member form a closed loop, the closed loop is fitted to tissue or organ or a part thereof during minimally invasive surgery, the base end of the flexible band is configured to be adjustablely stretchable, thereby allowing the part of the flexible band that forms a closed loop with the biocompatible variable shape to be reduced or extended, thereby allowing the loop to clamp tissue or organ or a part thereof.

[0006] Patent Document 5 describes a handle, a rigid sleeve extending from the handle, and a plurality of interconnected clips, each normally open by a proximal spring integrated with the clip, the clips housed in the sleeve, the clips having an automatic locking mechanism at their distal end, each of the clips being closed when housed in the sleeve, and an unlocked clip, and a retaining mechanism operable by the handle, which advances the clips toward the distal end of the sleeve, thereby exposing the most distal clip from the distal end of the sleeve, in preparation for retention. Disclosed is a laparoscopic clip applicator comprising: a placement mechanism configured to position the most distal clip of a clip, to open the most distal clip by exposure, to advance the sleeve relative to the exposed clip until the automatic locking mechanism of the exposed clip engages, thereby closing the exposed clip over biological tissue and thereby placing the exposed clip; and to retract the sleeve relative to the exposed clip, thereby exposing an interconnection mechanism located at the proximal end of the exposed clip, thereby making the exposed clip separable from the clip housed in the sleeve.

[0007] Patent Document 3 discloses a surgical instrument comprising opposing jaws, a handle, and at least one pressure sensor. This surgical instrument can be used to measure the stiffness of the pancreas during surgery, and the results can be used to shorten the surgical time. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] WO2020 / 189666A [Patent Document 2] US2009 / 0287088A [Patent Document 3] US11013453B [Patent Document 4] Special Publication No. 2016-531670 (WO2015 / 021443A) [Patent Document 5] Special Publication No. 2016-529929 (WO2015 / 040621A) [Overview of the project] [Problems that the invention aims to solve]

[0009] The object of the present invention is to provide an auxiliary device for facilitating the placement of a ligation device so as to compress a target organ with appropriate force, a ligation device that can be placed on a target organ so as to compress the target organ with appropriate force, and a system for ligating a target organ comprising the aforementioned auxiliary device and ligation device. [Means for solving the problem]

[0010] As a result of diligent research to solve the above problems, we have completed the present invention, which encompasses the following forms.

[0011] [1] Ligation instrument, A mechanism for observing the blood flow that nourishes a target organ, and It has an auxiliary device to facilitate the placement of the ligation instrument into the target organ, Ligation instruments are, It has a first jaw portion having a distal end and a proximal end, a second jaw portion having a distal end and a proximal end, and a locking mechanism. The first and second jaw portions are configured to be rotatably connected around their respective proximal ends as axes. The locking mechanism consists of a combination of a part located on the distal end of the first jaw and a part located on the distal end of the second jaw, and is configured to connect the distal end of the first jaw and the distal end of the second jaw in a way that allows adjustment of the width between which the first jaw and the second jaw grip the target organ, and to change the force that grips the target organ by adjusting the gripping width. Auxiliary devices for facilitating the placement of ligation instruments into target organs (hereinafter sometimes referred to as "placement assistance devices") are, A shaft having a distal end and a proximal end, A launchpad mechanism located on the distal end of the shaft. A handle mechanism provided on the proximal end side of the shaft, and It has a transmission mechanism configured to connect the launch pad mechanism and the steering mechanism, The launch pad mechanism is configured to allow the ligation device to be loaded in a releaseable manner. The transmission mechanism transmits motion from the handle mechanism to the ligation instrument, and is configured to adjust the clamping width between the first and second jaws, thereby changing the force with which the ligation instrument clamps the target organ. A system for ligating target organs.

[0012] [2] The system according to [1], further comprising means for observing the force that compresses a target organ. [3] The system according to [1] or [2], wherein the force with which the ligation device compresses the target organ when the ligation device has been placed in the target organ is configured such that the compression does not stop the flow of blood nourishing the target organ and substantially stops the leakage of secretions from the target organ.

[0013] [4] A shaft having a distal end and a proximal end, A launch pad mechanism located on the distal end of the shaft, A handle mechanism provided on the proximal end side of the shaft, and It has a transmission mechanism configured to connect the launch pad mechanism and the steering mechanism, The launch pad mechanism is configured to allow the ligation device to be loaded in a releaseable manner. The transmission mechanism transmits motion / action from the handle mechanism to the ligation instrument, and is configured to allow the clamping force applied by the ligation instrument to the target organ to be changed by adjusting the clamping width between the first and second jaws. An auxiliary instrument for facilitating the placement of a ligation instrument on a target organ.

[0014] 〔5〕 A launch pad mechanism, and a transmission mechanism configured to connect between the launch pad mechanism and a surgical support robot, where the launch pad mechanism is configured to be able to releasably load a ligation instrument and attach to the arm of a surgical support robot, and the transmission mechanism is configured to transmit motion / action from the surgical support robot to the ligation instrument, adjust the width sandwiched between the first jaw and the second jaw, and change the force with which the ligation instrument pinches the target organ. An auxiliary instrument for facilitating the placement of a ligation instrument on a target organ.

[0015] 〔6〕 The ligation instrument has a first jaw having a distal end and a proximal end, a second jaw having a distal end and a proximal end, and a lock mechanism, where the first jaw and the second jaw are configured to be pivotally connected about the sides of their respective proximal ends, and the lock mechanism consists of a combination of a site installed on the distal end side of the first jaw and a site installed on the distal end side of the second jaw, and is configured to be able to connect between the distal end side of the first jaw and the distal end side of the second jaw so as to adjust the width by which the first jaw and the second jaw sandwich the target organ, and change the force with which the target organ is pinched by adjusting the width of the sandwiching. The auxiliary instrument according to 〔4〕 or 〔5〕.

[0016] 〔7〕 The force with which the ligation instrument pinches the target organ when the placement of the ligation instrument on the target organ is completed is configured to be in a range such that the blood flow nourishing the target organ is not stopped by the pinching and the leakage of secretions from the target organ is substantially stopped. The auxiliary instrument according to 〔4〕, 〔5〕 or 〔6〕. 〔8〕 The auxiliary instrument according to 〔4〕, 〔5〕, 〔6〕 or 〔7〕, further having means for observing the force with which the target organ is pinched.

[0017] [9] Having a first jaw portion having a distal end and a proximal end, a second jaw portion having a distal end and a proximal end, and a locking mechanism, The first and second jaw portions are configured to be rotatably connected around their respective proximal ends as axes. A ligation device in which the locking mechanism consists of a combination of a part located on the distal end side of the first jaw and a part located on the distal end side of the second jaw, and the inner surfaces of the first jaw and the inner surfaces of the second jaw can be connected to each other so as to adjust the width with which they grip the target organ, and the force of clamping the target organ can be changed by adjusting the clamping width.

[0018]

[10] The ligation instrument according to [9], configured to be loaded into a launch pad mechanism configured to allow the ligation instrument to be released into an auxiliary device for facilitating the placement of the ligation instrument into a target organ.

[11] The ligation device described in [9] or

[10] , wherein the width of the ligation device that grips the target organ when the ligation device has been placed in the target organ is greatest at a position off-center from the middle of the first and second jaws toward the distal or proximal end, and is smallest at the distal and proximal ends of the first and second jaws, respectively.

[12] A ligation device according to any one of [9] to

[11] , wherein the force with which the ligation device compresses the target organ when it has been placed in the target organ is such that the compression does not stop the flow of blood nourishing the target organ and substantially stops the leakage of secretions from the target organ.

[13] A ligation device according to any one of [9] to

[12] , further comprising means for observing the force that compresses a target organ. [Effects of the Invention]

[0019] The implantation aid of the present invention facilitates the placement of a ligation instrument so as to compress the target organ with appropriate force. The ligation instrument of the present invention can be placed on the target organ so as to compress the target organ with appropriate force. The implantation aid or system for ligating a target organ of the present invention facilitates the placement of a ligation instrument in a short time so as to compress the target organ with appropriate force. According to the present invention, leakage of secretions due to insufficient compression or tissue necrosis or cell necrosis due to excessive compression can be effectively prevented. According to the present invention, the occurrence of various complications can be reduced, for example, in partial resection of organs such as the liver and pancreas. [Brief explanation of the drawing]

[0020] [Figure 1] This figure shows an example of the ligation device (stress-free state) of the present invention. [Figure 2] This figure shows an example of the implantation aid of the present invention in a state in which the ligation device of the present invention is loaded. [Figure 3] Figure 2 shows the band body released using the indwelling support device. [Figure 4] This figure shows the band body and the second jaw region released by the implantation support device shown in Figure 2. [Figure 5] This figure shows the target organ temporarily locked in place by the implantation support device shown in Figure 2. [Figure 6] Figure 2 shows the state in which the ligation device of the present invention is released from the implantation support device shown in Figure 2, and the target organ is locked in place. [Figure 7] This figure shows an example of a state in which the ligation device of the present invention is temporarily locked onto a target organ. [Figure 8] This figure shows another example of the implantation aid of the present invention, in the state before the ligation device of the present invention is loaded. [Figure 9] This figure shows another example of the implantation aid of the present invention in a state in which the ligation device of the present invention is loaded. [Figure 10] This figure shows the arm of the indwelling support device shown in Figure 9 in the open position. [Figure 11] Figure 9 shows the band body released using the indwelling support device. [Figure 12] Figure 9 shows the state in which the target organ is held in place by the implantation support device. [Figure 13] This figure shows the target organ temporarily locked in place by the implantation support device shown in Figure 9. [Figure 14] This figure shows the ligation device of the present invention released from the indwelling support device shown in Figure 9, in the locked state. [Figure 15] This figure shows the indwelling support device shown in Figure 9 after the ligation device of the present invention has been released. [Figure 16] This figure shows an example of a connecting section 4a. [Figure 17] This figure shows several examples of the internal shape of the ring (formed by the first jaw portion, the second jaw portion, and a portion of the band body) that is formed when the implantation is complete. [Modes for carrying out the invention]

[0021] Embodiments of the present invention will be described with reference to the drawings. The present invention provides a system for ligating a target organ, a mechanism for observing the blood flow supplying the target organ, and an auxiliary device for facilitating the placement of the ligation device in the target organ.

[0022] The ligation device of the present invention has a first jaw portion 2, a second jaw portion 3, and a locking mechanism.

[0023] The first jaw portion 2 is a rod-shaped member having a distal end 2d and a proximal end 2p. The second jaw portion 3 is a rod-shaped member having a distal end 3d and a proximal end 3p. The first jaw portion and the second jaw portion are preferably made of medical materials, more preferably made of biocompatible polymers or biocompatible metals, and even more preferably made of biodegradable polymers. The first jaw portion and the second jaw portion may be formed from bulk (lumps) or from fibers such as mesh, woven fabric, or nonwoven fabric, but they are preferably formed from bulk to reduce bending.

[0024] The ligation device of the present invention can be obtained, for example, by forming the shape of each part integrally or individually from a polymer, which is a medical material, using a known resin molding method. Examples of polymers include lactic acid polymers, lactic acid-glycolic acid polymers, trimethylene carbonate polymers, dioxanone polymers, polyethylene glycol polymers, and lactone polymers. These polymers can be used individually or in combination of two or more. Examples of resin molding methods include injection molding, compression molding, and additive manufacturing.

[0025] The first and second jaw portions are rotatably connected around their respective proximal ends. This rotation allows the first and second jaw portions to be positioned at various angles (e.g., between 0 and 360 degrees) around the axis, with their distal ends positioned at different angles. For example, they can be positioned at approximately 180 degrees around the axis, or at approximately 0 degrees. In the configuration where the distal ends are positioned between 0 and approximately 25 degrees around the axis, the inner surfaces of the first and second jaw portions face each other. The target organ is then sandwiched between these two opposing inner surfaces.

[0026] The portion (connecting portion) 4a connecting the proximal end of the first jaw portion 2 and the proximal end of the second jaw portion 3 may be, for example, a short flexible strip-shaped member or a hinge member. Furthermore, the connecting portion 4a may have a structure that allows for disconnection, enabling the first jaw portion 2 and the second jaw portion 3 to be separated as appropriate. The connecting portion 4a may be a U-shaped flexible strip member, a C-shaped flexible strip member, or a U or C-shaped flexible strip member with a peninsula portion 12 protruding inward from each jaw portion toward the apex of the connecting portion 4a. Connecting portions 4a of these shapes can make the gap between the first jaw portion and the second jaw portion more parallel or closer in contact, allowing for uniform clamping of the target organ or reducing the risk of clamping a part of the organ with the connecting portion 4a. The installation of a peninsula portion is particularly expected to reduce the risk of clamping a part of the organ with the connecting portion 4a. The connecting portion 4a is preferably made of a medical material, more preferably a biocompatible polymer or biocompatible metal, and even more preferably a biodegradable polymer.

[0027] The inner surfaces of the first jaw and the second jaw may, independently, be straight between the distal and proximal ends, curved inwardly concavely between the distal and proximal ends, or curved inwardly convexly between the distal and proximal ends. Specifically, examples include a configuration in which both the inner surfaces of the first and second jaws are curved inwardly convexly between the distal and proximal ends, a configuration in which both the inner surfaces of the first and second jaws are curved inwardly concavely between the distal and proximal ends, a configuration in which the inner surface of the first jaw 2 is curved inwardly concavely between the distal and proximal ends and the inner surface of the second jaw 3 is curved inwardly convexly between the distal and proximal ends, and the inner surface of the first jaw 2 is curved inwardly convexly between the distal and proximal ends and the inner surface of the second jaw 3 is curved inwardly concavely between the distal and proximal ends. From the viewpoint of enabling smooth ligation of the target organ, a form in which both the inner surface of the first jaw and the inner surface of the second jaw are curved inwardly in a concave shape between the distal and proximal ends is preferable. It is preferable that, when the ligation device of the present invention is placed in the target organ, the width with which the ligation device grips the target organ is maximized at a position offset from the center of the first and second jaws toward the distal or proximal ends, and minimized at the distal and proximal ends of the first and second jaws, respectively. This configuration is preferable from the viewpoint of being able to clamp the target organ with uniform force and from the viewpoint of preventing the organ from escaping toward the free end (towards the distal ends of the first and second jaws) when the device is closed. Preferably, the portion where the width gripping the target organ is maximized is offset from the center of the first and second jaws toward the distal or proximal ends, by preferably 3 to 45%, more preferably 8 to 35%, and even more preferably 10 to 30%, relative to the length from the distal end to the proximal end of the first and second jaws.

[0028] The inner surfaces of the first and second jaws may be rough to increase friction with the target organ during ligation and prevent slippage, or they may have longitudinally extending convex or concave ridges, or a grid of convex or concave ridges, or they may have multiple convex or concave points. Providing convex or concave ridges parallel to the longitudinal direction on the inner surfaces of the first and second jaws, especially near the edges, can improve the prevention of secretion leakage and hemostasis.

[0029] The locking mechanism consists of a combination of a part located on the distal end of the first jaw and a part located on the distal end of the second jaw. The distal end of the first jaw and the distal end of the second jaw can be connected in such a way that the width between them when gripping the target organ can be adjusted, and the force that grips the target organ can be changed by adjusting the gripping width.

[0030] Examples of combinations in the locking mechanism include a combination of a ratchet pawl installed on the distal end side of the second jaw and a plurality of ratchet teeth arranged longitudinally on a band body installed on the distal end side of the first jaw; a combination of at least one recess installed on the distal end side of the second jaw and a plurality of projections arranged longitudinally on a band body installed on the distal end side of the first jaw; or a combination of at least one projection installed on the distal end side of the second jaw and a plurality of recesses arranged longitudinally on a band body installed on the distal end side of the first jaw.

[0031] Examples of projections in the locking mechanism include pins and hooks. Examples of recesses include holes, loops, constrictions, and notches. Multiple projections or recesses provided on the band may be spherical or annular in shape and arranged in a bead-like fashion, or they may be sawtooth-shaped with protrusions on both sides, or they may be ladder-shaped. It is preferable that the projections in the locking mechanism have a barb to prevent them from coming out of the recess into which they are inserted. The projections with barbs may be in the shape of an inverted L, a T, or a cross. Multiple recesses provided on the band may be meshes in fabric or netting, as long as the projection can be inserted through them. As a combination of hook and loop, for example, hook-and-loop fasteners may be used.

[0032] A ratchet, an example of a locking mechanism, is a mechanism used to restrict the direction of movement to one direction. It is tightened by engaging the ratchet teeth 6 with the ratchet pawl 5. Ratchet pawls can be movable or fixed. When a ratchet tooth is engaged with a movable ratchet pawl, the engagement can be easily released. When a ratchet tooth is engaged with a fixed ratchet pawl, it is difficult to release the engagement. When both a fixed and a movable ratchet pawl are used, the band body can first be temporarily locked by the movable ratchet pawl, and if the tightening force on the target organ is too tight, the engagement can be released to loosen the tightening force, and then, once the tightening force is determined, the band body can be permanently locked by the fixed ratchet pawl to prevent the position from changing.

[0033] When fastened by the locking mechanism, the distal end of the first jaw and the distal end of the second jaw are connected via the portion of the band body closer to the first jaw, causing the connecting portion 4a to bend and forming a loop with the first jaw, the second jaw, and the corresponding portion of the band body. The shape of the loop formed when the implantation is complete is not particularly limited, but a loop similar in shape to the shape of an organ or tissue when it is crushed is preferred. The rings formed upon completion of implantation include: elliptical or biconvex lens-shaped rings (Figure 17(a)); semicircular or uniconvex lens-shaped rings (such as a shape where a part of a circle is cut off by a straight line) (Figure 17(b)); convex meniscus lens-shaped rings (Figure 17(f)); triangular or triangular rings (where the first jaw, second jaw, and the relevant part of the band body form the three sides) (Figures 17(e1), (e2), etc.); oval-shaped rings (an ellipse resembling a chicken egg; a shape where the radius of curvature of one end (the pointed end) is smaller than the radius of curvature of the other end (the obtuse end) at two points on the circumference where the major axes of the ellipse intersect; a shape defined in Hirotaka Ebisu, "The Minor Axis of Descartes' Ovoid Line and the Ovoid Surface," Geometry Research No. 68, June 1995, pp. 3-8, etc.) (Figures 17(c1), (c2), etc.); The rings may be semi-elliptical or semi-oval (such as an elliptical or oval shape with a part cut off by a straight line) (Figures 17(d1), (d2), etc.); progressive lens-shaped rings (Figures 17(g1), (g2), etc.); or polygonal rings with four or more angles or four or more sides. Preferably, the remaining portion of the band body is configured to follow the outer surface of the second jaw.

[0034] The portion of the band connecting the distal end of the first jaw and the distal end of the second jaw, closer to the first jaw, can have its length changed by altering the fastening position. As a result, the width between the inner surfaces of the first and second jaws that grip the target organ can be changed. By adjusting this gripping width, the force applied to the target organ can be altered.

[0035] It is preferable that a groove or through-hole is provided on the end face or outer surface of the second jaw so that the band body fits into the distal end of the second jaw. Alternatively, it is preferable that a groove is provided on the inner surface of the first jaw so that the distal end of the second jaw fits into the distal end of the first jaw. This groove or through-hole prevents the distal end of the first jaw and the distal end of the second jaw from being misaligned.

[0036] Mechanisms for aligning the band body with the outer surface of the second jaw portion 3 include a belt loop 7 provided on the outer surface of the second jaw portion through which the band body can be inserted, a groove provided on the outer surface of the second jaw portion with a shape corresponding to the band body, and holes, loops, hooks, and pins with barbs provided on the outer surface of the second jaw portion corresponding to pins with barbs, hooks, loops, and holes provided on the inner surface of the band body. A ratchet pawl may be provided on the belt loop 7 for fixing the band body. In a pile-and-hook system, where a pile (thin loop) and a hook are paired, the hook is fixed by the protrusion of the hook becoming entangled with the pile. In a hole-and-hook system, where a hole and a hook are paired, the hook is fixed by fitting into the hole.

[0037] Furthermore, in order to fold the band body 1 back at the distal end of the second jaw portion 3 and smoothly conform it to the outer surface of the second jaw portion, it is preferable that the outer surface of the second jaw portion has a structure in which it is curved outward, at least near the distal end. It is preferable that this structure has a shape that conforms tightly to the outer surface of the second jaw portion when the band body 1 is fastened to the locking mechanism. When the band body 1 is tightly locked as described above, a stable tightening force is obtained on the target organ and it is less likely to loosen. In addition, this structure can guide the direction of the ratchet teeth on the band body 1 relative to the ratchet pawl on the second jaw portion to an orientation that ensures a secure bite between the two. This structure prevents the band body 1 from being oriented in a direction that is not suitable for bite and places a large load on the ratchet pawl, thereby reducing the risk of damage to the ratchet pawl.

[0038] The proximal end of the band body 1 and the distal end of the first jaw portion 2 are connected via a connecting portion 4b. Preferably, the proximal end of the band body and the distal end of the first jaw portion are connected in a way that creates an inward recess. The connecting portion 4b may be, for example, a short flexible band-shaped member or a hinge member. The connecting portion 4b may also have a structure that allows for disconnection, so that the first jaw portion 2 and the band body 1 can be separated as appropriate. The connecting portion 4b is preferably made of a medical material, more preferably a biocompatible polymer or biocompatible metal, and even more preferably a biodegradable polymer.

[0039] Furthermore, it is preferable that the band body is more flexible than the first and second jaws. The method for adjusting the flexibility is not particularly limited; for example, if the band body, first jaw, and second jaw are made from the same material, it can be done by adjusting the thickness or diameter. The flexibility can be reduced by increasing the thickness of a part of it, such as by adding a rib. In addition, the flexibility can be increased by providing multiple grooves (for example, grooves between the ratchet teeth 6) on the outer surface of the band body in a direction perpendicular to the bending direction. It is preferable to provide a rib or the like on the distal end of the band body to increase its rigidity compared to the proximal end of the band body, as this can suppress buckling and facilitate insertion into the locking mechanism.

[0040] The locking mechanism is preferably made of medical materials, more preferably of biocompatible polymers or biocompatible metals, and even more preferably of biodegradable and absorbable polymers. The band may be formed in bulk, or it may be made of fibers such as mesh, woven fabric, or nonwoven fabric. Furthermore, the locking mechanism (such as the band), the first jaw portion, and the second jaw portion are not particularly limited in terms of their length, thickness, size, elastic modulus, etc., and can be appropriately set according to, for example, the shape and size of the target organ being treated.

[0041] The ligation device of the present invention is preferably configured to be loaded into a launch pad mechanism, which is configured to allow the ligation device to be released, as part of an auxiliary device for facilitating the placement of the ligation device into a target organ. Specifically, it may have a receiving means corresponding to a means for release loading. For example, if the launch pad mechanism has a chuck configured to grip the ligation device, the ligation device of the present invention has a chuck receiver, which is the part that is gripped. Furthermore, the ligation device of the present invention is preferably configured to pass through narrow passages such as laparoscopic ports. This configuration corresponds to the configuration of the launch pad mechanism; for example, if the launch pad mechanism has a part that forms a two-fork shape, it is preferable that the ligation device of the present invention is configured to fit between the two teeth of the two forks. Furthermore, if the launch pad mechanism has a part that forms a capsule shape with a lid, it is preferable that the ligation device of the present invention is configured to fit inside the capsule.

[0042] The ligation device of the present invention is preferably configured such that, in a stress-free state, the band body 1 and the first jaw portion 2 are positioned to grasp the target organ 49, and more preferably, the band body 1, the first jaw portion 2, and the second jaw portion 3 are positioned to grasp the target organ 49. Furthermore, as shown in Figure 8, it is preferable to set the length of the band body 1 such that when the band body 1 is folded towards the first jaw portion 2, the band body 1 fits between the first jaw portion 2 and the second jaw portion 3.

[0043] The ligation device of the present invention may further include means for observing the force with which it compresses a target organ. Examples of means for observing the force with which it compresses a target organ include pressure sensors and strain sensors. The means for observing the force with which it compresses can be installed at a desired position depending on the principle of measurement. For example, it can be installed on the inner surface of the first or second jaw portion, or on the connecting portion 4a of the first and second jaw portions. The observed values ​​can be transmitted by a transmission mechanism described later or by wireless communication. This allows for information such as whether the ligation device has detached from the target organ after surgery. Preferably, the force with which the ligation device compresses the target organ when it is placed in the target organ is configured to be within a range where the blood flow nourishing the target organ is not stopped by the compression, and leakage of secretions from the target organ is substantially stopped. A load limiter or the like can be used to prevent excessive load. In this invention, "leakage of secretions from the target organ" refers to leakage of secretions from the stump or wound of the target organ. Postoperative pancreatic fistula refers to the meaning defined, for example, by the International Study Group for Pancreatic Surgery (ISGPS). Substantially stopping the leakage of secretions means, for example, that the concentration of secretions in the drain fluid (e.g., amylase in the case of the pancreas, bilirubin in the case of the liver) becomes 3 times or less the normal serum value from the third day postoperatively onward, or that the concentration of secretions in the ascites fluid (e.g., amylase in the case of the pancreas, bilirubin in the case of the liver) becomes 3 times or less the normal serum value, preferably 2 times or less, and more preferably 1 time or less during surgery.

[0044] The present invention provides an auxiliary device (placement aid) for facilitating the placement of a ligation instrument into a target organ, comprising a shaft, a launch pad mechanism, a handle mechanism, and a transmission mechanism.

[0045] A shaft is a rod-shaped member having a distal end and a proximal end. For example, in laparoscopic surgery, surgical instruments may be inserted into the abdominal cavity from outside the body through a laparoscopic port provided in the abdominal wall. The diameter and length of the shaft are not particularly limited as long as they do not hinder handling during surgery. For example, in laparoscopic surgery, the shaft can be diameter sufficient to pass through the laparoscopic port and long enough to reach the location of the target organ. The shaft may have a lumen (internal cavity) connecting the proximal end to the distal end. A transmission mechanism, etc., described later, can be housed in this lumen. The surgery may be performed by a physician directly operating the ligation device, auxiliary device, or system for ligating a target organ of the present invention, or by a physician indirectly operating the ligation device, auxiliary device, or system for ligating a target organ of the present invention via a surgical support robot. The surgical support robot includes, for example, a patient unit equipped with a robotic arm configured to perform surgical procedures on a patient, and a surgeon unit configured to allow a physician to control the movement of the patient unit. Examples of surgical support robots include the hinotori surgical robot system (manufactured by Medicaroid), the da Vinci Surgical System (manufactured by Intuitive Surgical), the EMARO surgical robot system (manufactured by Riverfield), and the Mazor X robot system (manufactured by Medtronic Japan).

[0046] The launch pad mechanism is located on the distal end of the shaft. The handle mechanism is located on the proximal end of the shaft. The transmission mechanism is configured to connect the launch pad mechanism and the handle mechanism. The transmission mechanism transmits motion from the handle mechanism to the launch pad mechanism or the ligation instrument, and is configured to adjust the clamping width between the first and second jaws, thereby changing the clamping force applied by the ligation instrument to the target organ. The transmission mechanism may include means for transmitting mechanical driving force, means for transmitting electrical and electronic signals, etc. The handle mechanism may have one or more parts, such as a part for the operator to grasp, a part for operator operation such as a button, knob, dial, lever, or touch panel, or a part for connecting to external equipment such as a monitor or measuring instrument. The handle mechanism may also have a part that displays information such as the blood flow nourishing the target organ or the clamping force applied by the ligation instrument to the target organ, but this information display part may be placed in a location easily visible to the operator, for example, in the part that displays images taken with a laparoscope.

[0047] The launch pad mechanism is configured to allow for the release loading of a ligation device to be placed in the target organ. Means for release loading include, for example, a chuck or forceps configured to grasp the ligation device. The ligation instrument loaded into the launch pad mechanism is positioned so that it can pass through the laparoport, for example, with the distal end of the first jaw and the distal end of the second jaw positioned at approximately 180 degrees, or with the distal end of the first jaw and the distal end of the second jaw positioned at approximately 0 degrees. Then, the handle mechanism is operated, and the loading means in the launch pad mechanism is moved via the transmission mechanism to position the first and second jaws of the ligation instrument loaded into the launch pad mechanism so that they can grasp the target organ (Figures 3-4, 10-11, etc.).

[0048] In robotic surgery, the handle mechanism constituting the auxiliary device of the present invention may be operated by forceps or the like attached to the robotic arm of the patient section of the surgical assistance robot. Furthermore, if the launch pad mechanism is configured to be attached to the robotic arm of a surgical robot, the launch pad mechanism can be attached to the robotic arm of the surgical robot. When the launch pad mechanism is attached to the robotic arm of a surgical robot, the aforementioned shaft corresponds to the robotic arm of the surgical robot, the handle mechanism corresponds to the control stick of the surgeon section of the surgical robot, and the transmission mechanism transmits motion from the surgical robot to the launch pad mechanism or ligation instrument, and is configured to change the clamping force applied by the ligation instrument to the target organ by adjusting the clamping width between the first and second jaw sections.

[0049] In one embodiment, for example, a ligation device 100, in which the band body 1, the first jaw portion 2, and the second jaw portion 3 are arranged to grasp a target organ 49 in a stress-free state as shown in Figure 1, is loaded with stress by means of a releasable loading mechanism such as a chuck, thereby spreading the distal end of the first jaw portion and the distal end of the second jaw portion so that they are arranged at approximately 180 degrees, as shown in Figure 2, and folding the band body 1 closer to the first jaw portion. The device is then grasped with chucks 43a, 43b, 43c, and 43d and loaded into the launch pad mechanism 43.

[0050] After insertion into the abdominal cavity, the band body 1 expands as shown in Figure 3 by releasing the chuck 43b that grips the band body 1, and the band body 1 is positioned as shown in Figure 4 by releasing the chuck 43d that grips the second jaw portion 3. The target organ 49 is placed between the first jaw portion and the second jaw portion, and the second jaw portion 3 is pushed down by the rod 42, which is one of the transmission mechanisms, and the ratchet pawl at the distal end of the second jaw portion engages with the ratchet teeth on the band body 1, etc., to temporarily lock it as shown in Figure 5. The ligation device used here may have a structure in which the ratchet teeth 6 provided on the band body 1 and the ratchet pawl 5 provided on the second jaw portion 3 engage and a temporary lock is achieved solely by the pressing force of the rod 42. Specifically, the lengths of the first jaw portion 2 and the second jaw portion 3, the relative positioning of the band body 1, the first jaw portion 2, and the second jaw portion 3 via the connecting portions 4a and 4b (particularly the angle between the band body 1 and the first jaw portion 2 in a stress-free state), the flexibility of the band body 1, and the mounting position of the ratchet pawl 5 on the second jaw portion 3 are all adjusted for this purpose. Next, the tip of the band body 1 is grasped with the rod 42 and pulled towards the handle mechanism along the outer surface of the second jaw. This adjusts the width between the first and second jaws while clamping the target organ. The clamping force can be calculated by the force applied to the rod 42. The level of this force can be indicated by the display 44 on the handle mechanism. The means for observing the clamping force on the target organ are not limited to those described above, and known load measuring means such as pressure sensors, strain sensors, and spring scales may be used. The ligation device is released by releasing the chucks 43a and 43c when the clamping force reaches the desired value. The clamping force applied by the ligation device to the target organ when it is placed in the target organ can be adjusted based on observed blood flow to the target organ so that the clamping force does not stop the blood flow nourishing the target organ and substantially stops the leakage of secretions from the target organ. Furthermore, the force applied to the target organ may be configured such that the blood flow supplying the target organ is not interrupted by the clamping, and leakage of secretions from the target organ is substantially stopped. In addition, a load limiter or the like can be used to prevent excessive load. In this embodiment, each chuck can be operated by the operation button 51, and the movement of the rod 42 can be operated by the operation dial 45, levers 46, 48, etc.

[0051] In another embodiment, the ligation device is folded between the first and second jaw sections as shown in Figure 8, and then grasped by chucks 63a, 63b, 63c, 63d, and 63e on the arms of the launch pad mechanism 63 using a means for release loading such as a chuck, and loaded into the launch pad mechanism 63. When used in laparoscopic surgery, the arms of the launch pad mechanism 63 are closed so that the distal end of the first jaw section and the distal end of the second jaw section are positioned at approximately 0 degrees as shown in Figure 9, allowing it to pass through the laparoport. After insertion into the abdominal cavity, the arms are spread and the chuck 63b that grips the band section 1 is released, causing the band section 1 to spread as shown in Figure 11. The target organ 49 is then placed between the first and second jaw sections. The arms are closed, and the ratchet teeth on the band section 1 engage with the ratchet pawls on the distal end of the second jaw section, temporarily locking it as shown in Figure 13. The ligating device used here, like the one described above using Figure 5, has a structure that allows temporary locking to be achieved solely through operation via the launch pad mechanism 63. As shown in Figure 13, the band body 1 is positioned to follow the outer surface of the arm that grips the second jaw. Release the chucks 63a, 63c, 63d, and 63e. Grasp the tip of the band body 1 with the tips of the two arms and pull it towards the handle mechanism, following the outer surface of the second jaw. This adjusts the width between the first and second jaws while clamping the target organ with the desired force.

[0052] A mechanism for observing the blood flow nourishing a target organ may include means for measuring pressure pulse waves, means for detecting Korotkoff sounds, means for measuring light transmission and reflection, means for measuring ultrasound transmission and reflection, and means for injecting contrast agents such as fluorescent dyes and taking images. It may further include means for imaging these measurement results. The mechanism for observing blood flow may be a dedicated device for observing fluid flow, or it may be attached to other medical equipment, as long as it can observe the blood flow nourishing the target organ. For example, it may be installed on the aforementioned ligation device, an auxiliary device for facilitating placement in the target organ, or other medical equipment (e.g., forceps, laparoscopic port, laparoscope, etc.).

[0053] In addition to a mechanism for observing the blood flow nourishing the target organ, the system of the present invention may also have a mechanism for monitoring other conditions of the patient during surgery. Examples of patient monitors during surgery include a pulse oximeter that can measure blood oxygen concentration, a capnometer that can measure carbon dioxide concentration in inhaled and exhaled air, a ventilation monitor that can measure airway pressure, an electrocardiogram monitor, a blood pressure monitor, a body temperature monitor, and a muscle relaxation monitor.

[0054] The target organs to which the present invention can be applied are not particularly limited as long as the ligation treatment is effective, but examples include organs with tubular structures such as blood vessels, lymphatic vessels, thoracic duct, bile duct, fallopian tube, vagina, ureter, urethra, vas deferens, trachea, bronchi, etc.; pancreas, liver, gallbladder, spleen, kidney, bladder, uterus, ovaries, testes, lungs, heart, thyroid gland, esophagus, stomach, duodenum, small intestine, large intestine, lymph nodes, etc. The present invention can be preferably used for ligation of the pancreas, and more preferably for ligation of the body or tail of the pancreas during pancreatectomy. The present invention can be preferably used for ligation of the liver, and more preferably for ligation of the liver parenchyma during hepatic bleeding, and can be used for the purpose of reducing hepatic bleeding during hepatic resection. The present invention can be preferably used for ligation of the spleen, and more preferably for ligation of the splenic parenchyma during splenic bleeding, and can be used for the purpose of reducing splenic bleeding during splenectomy. The present invention can be preferably used for ligation of the kidney, and more preferably for ligation of the renal parenchyma during renal bleeding, and can be used for the purpose of reducing renal bleeding during nephrectomy.

[0055] Because target organs are easily deformed and fragile, conventional ligation instruments used to ligate their stumps have typically been shaped to approximate the external form of the cut surface, in order to minimize tissue damage caused by ligation, such as tissue necrosis due to obstruction of blood flow within the tissue, and to apply as much uniform pressure as possible to the cut surface of the organ. For example, for the stump treatment of the pancreas, a roughly circular ligation instrument has traditionally been used. However, if a tubular structure exists within the target organ, cutting the organ exposes the opening of the tubular structure at the cut surface. Furthermore, if the tubular structure contains secretions that may damage surrounding tissues, such as digestive fluids, preventing their leakage becomes a challenge during target organ ligation. A pancreatic fistula is an example of this. However, with conventional roughly circular ligation instruments, if the ligation is performed loosely to avoid excessive pressure on the target organ, it is not possible to sufficiently effectively seal the opening of the tubular structure at the cut surface of the target organ. On the other hand, prioritizing the occlusion of the lumen structure results in excessive pressure being applied to the target organ, leading to significant problems of impaired blood flow within the target organ and subsequent tissue necrosis. In other words, there is a trade-off between the need to reduce tissue damage caused by ligation and the need to suppress fluid leakage from the lumen structure opening at the cut surface of the target organ.

[0056] As described above, the present invention provides a first and second jaw portion having a specific shape and specific flexibility, as well as an adjustable locking mechanism that allows for appropriate maintenance of the distance between the distal end of the first jaw portion and the distal end of the second jaw portion during ligation. This allows for adjustment to minimize obstruction of blood flow within the target organ due to pinching and the resulting necrosis. Moreover, according to the present invention, even if there is a tubular structure within the target organ, its opening can be effectively closed. In other words, the present invention makes it possible to achieve both a reduction in tissue damage due to ligation and suppression of fluid leakage from the opening of the tubular structure at the cross-section of the target organ. Furthermore, taking the case where the target organ is the pancreas as an example, by adjusting the force applied to ligate the pancreas, the ligation device of the present invention can be fixed to the pancreas while maintaining the opening of the tubular structure, and the digestive tract and tissues can be sutured in pancreatic-gastrointestinal anastomosis. The present invention is preferably applied to laparoscopic surgery. [Explanation of Symbols]

[0057] 1: Band body 2: First jaw 3:Second jaw 4a: Connecting part between the first and second jaw sections 4b: Connection between the band body and the first jaw portion 5: Ratchet pawl 6: Ratchet teeth 7: Belt loop 12: Peninsula 1p: Proximal end of the band body 1d: Distal end of the band 2p: Proximal end of the first jaw 2d: Distal end of the first jaw 3p: Proximal end of the second jaw 3D: Distal end of the second jaw 41,61: Shaft 42,62: Rod 43,63: Launchpad mechanism 43a, 43b, 43c, 43d: Chuck 63a, 63b, 63c, 63d, 63e: Chuck 55a, 55b, 55c, 55d: Chuck receiver 75a, 75b, 75c, 75d, 75e: Chuck receiver 44,64: Sections that display information 45, 65: Operation dial 46,66: Operating lever 47,67: Gripping lever 48,68: Operation knob 49: Target organs 50, 70: Handle mechanism 51,71: Operation buttons 100,200: Ligation equipment

Claims

1. ligation equipment, A mechanism for observing the blood flow that nourishes a target organ, and It has an auxiliary device to facilitate the placement of the ligation instrument into the target organ, Ligation instruments are, It has a first jaw portion having a distal end and a proximal end, a second jaw portion having a distal end and a proximal end, a band body having a distal end and a proximal end, and a locking mechanism. The first and second jaw portions are configured to be rotatably connected around their respective proximal ends as axes. The locking mechanism consists of a band body installed on the distal end side of the first jaw and a portion installed on the distal end side of the second jaw, and is configured to connect the distal end side of the first jaw and the distal end side of the second jaw so that the width between the first jaw and the second jaw that grips the target organ can be adjusted, and by adjusting the gripping width, the force with which the first jaw and the second jaw constricts the target organ can be set to a desired value. Auxiliary devices for facilitating the placement of ligation instruments into target organs are, A shaft having a distal end and a proximal end, A launch pad mechanism located on the distal end of the shaft, A handle mechanism provided on the proximal end side of the shaft, and It has a transmission mechanism configured to connect the launch pad mechanism and the steering mechanism, The launch pad mechanism is configured to allow the ligation instrument to be loaded in a releaseable manner, and is provided with a chuck or forceps configured to grasp the band body of the ligation instrument, a chuck or forceps configured to grasp the first jaw of the ligation instrument, and a chuck or forceps configured to grasp the second jaw of the ligation instrument, each independently provided. The transmission mechanism transmits motion from the handle mechanism through the launch pad mechanism to the ligation instrument, and is configured to allow adjustment of the clamping width between the first and second jaws, thereby changing the force with which the ligation instrument clamps the target organ. A system for ligating target organs.

2. The system according to claim 1, further comprising means for observing the force that compresses a target organ.

3. A shaft having a distal end and a proximal end, A launch pad mechanism located on the distal end of the shaft, A handle mechanism provided on the proximal end side of the shaft, and It has a transmission mechanism configured to connect the launch pad mechanism and the steering mechanism, The launch pad mechanism is configured to allow the release loading of a ligation instrument having a first jaw, a second jaw, a band body, and a locking mechanism, and is provided with independently operated chucks or forceps capable of gripping the band body of the ligation instrument, chucks or forceps capable of gripping the first jaw of the ligation instrument, and chucks or forceps capable of gripping the second jaw of the ligation instrument. The transmission mechanism transmits motion from the handle mechanism through the launch pad mechanism to the ligation instrument, and is configured to allow adjustment of the clamping width between the first and second jaws, thereby changing the force with which the ligation instrument clamps the target organ. An auxiliary device to facilitate the placement of ligation instruments into target organs.

4. Launchpad mechanism, and It has a transmission mechanism configured to connect the launch pad mechanism and the surgical assistance robot. The launch pad mechanism is configured to allow a ligation instrument having a first jaw portion, a second jaw portion, a band body, and a locking mechanism to be released and to be attached to the arm of a surgical assistance robot, and is provided with independently operated chucks or forceps configured to grasp the band body of the ligation instrument, chucks or forceps configured to grasp the first jaw portion of the ligation instrument, and chucks or forceps configured to grasp the second jaw portion of the ligation instrument. The transmission mechanism transmits motion from the surgical support robot to the ligation instrument via the launch pad mechanism, and is configured to adjust the clamping width between the first and second jaws, thereby changing the force with which the ligation instrument clamps the target organ. An auxiliary device to facilitate the placement of ligation instruments into target organs.

5. Ligation instruments are, The first jaw portion has a distal end and a proximal end, the second jaw portion has a distal end and a proximal end, and the band body has a distal end and a proximal end. The first and second jaw portions are configured to be rotatably connected around their respective proximal ends as axes. The locking mechanism consists of a band body installed on the distal end of the first jaw and a portion installed on the distal end of the second jaw, and is configured to connect the distal end of the first jaw and the distal end of the second jaw so that the width between the first jaw and the second jaw that grips the target organ can be adjusted, and by adjusting the gripping width, the force with which the first jaw and the second jaw constrict the target organ can be set to a desired value. The auxiliary device according to claim 3 or 4.

6. The auxiliary device according to claim 3 or 4, further comprising means for observing the force that compresses a target organ.

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