Medical devices suitable for ligation and the like

Abstract

A medical instrument has a flexible band having a distal end and a proximal end, a flexible first rod having a distal end and a proximal end, and a flexible second rod having a distal end and a proximal end. The distal end of the band is connected to the proximal end of the first rod. The distal end of the first rod is connected to the proximal end of the second rod via a connection portion. The band is more flexible than the first and second rods. The second rod has a locking portion. The band has a locking counterpart portion. When the locking portion and the locking counterpart portion are fastened and connected, the proximal end of the first rod and the distal end of the second rod are connected via a portion of the band. The connection portion is bent. A loop of a desired size can be formed by the first rod, the second rod, and the portion of the band. The second rod also has a mechanism that, when the locking portion and the locking counterpart portion are fastened and connected, causes a remaining portion of the band to follow the outer surface of the second rod from the distal end toward the proximal end of the second rod.

Description

Technical Field

[0001] This invention relates to medical devices. More specifically, it relates to medical devices suitable for ligation and the like, which are used to prevent various complications during partial resection of biological tissues (e.g., organs, systems) such as the liver, pancreas, and blood vessels, with minimal invasiveness. Background Technology

[0002] Ligation is performed to bring together and fix tissues severed due to trauma, to ligate the lumen of blood vessels or fallopian tubes, to tie and fix tissues to close hernias, or to tie up tissues to stop blood flow, causing necrosis and sloughing. Various medical devices for ligation have been proposed.

[0003] For example, Patent Document 1 discloses a tourniquet for ligation, characterized in that a tourniquet body of a predetermined length has an anti-disengagement engagement portion continuously formed in the length direction of the tourniquet body within a range that constitutes an interference fit, and anti-slip ribs are continuously formed at appropriate positions on the tourniquet body within the range of the anti-disengagement engagement portion. Furthermore, a buckle portion is integrally formed at the base end of the tourniquet body. The buckle portion is formed as a short channel with an insertion port on one side and an outlet port on the other side, and a locking hook is formed at an appropriate position on the inner side. The locking hook can lock the anti-disengagement engagement portion of the tourniquet body inserted from the front end in a manner that prevents it from disengaging. The entire tourniquet for ligation is made of a flexible synthetic resin molded product.

[0004] Patent document 2 discloses a medical device for tissue ligation, characterized in that it comprises: an elongated flexible band having a front side, a rear side, a front end, and a rear end, and having a perforation and a transverse rib portion defined therein; a locking housing connected to the rear end of the band and having a channel sized to accommodate the band; and a locking member connected to the locking housing and configured in association with the channel, and configured to connect with the perforation and transverse rib portion defined therein, wherein the channel in the locking housing includes an arched portion disposed on the opposite side of the locking member, and the band is configured such that, when the locking member engages with the transverse rib portion of the band, the band becomes arched above the locking member and at least partially protrudes into the arched portion.

[0005] Patent document 3 discloses an organ stump treatment tool, comprising: a slender, flexible first band portion made of a biodegradable absorbable polymer and having a distal end and a proximal end; a slender, flexible second band portion made of a biodegradable absorbable polymer and having a distal end and a proximal end; and a first locking portion made of a biodegradable absorbable polymer and having a first pawl, the first locking portion being formed at the distal end of the second band portion, the distal end of the first band portion engaging with the proximal end of the second band portion, and at least one ratchet tooth formed on the outer surface of the first band portion capable of engaging with the first pawl, forming a flat ring by engaging the ratchet tooth with the first pawl, and using the ring to tightly bind the organ to ligate the tube or lumen opening at the organ stump.

[0006] Patent document 4 discloses an intestinal clamp, characterized in that it consists of two rigid rods with flexible bands at one end, a connecting part connected to the rods, and at least one through hole provided in one of the bands. By inserting the other band from the front end side through the through hole, the two rods clamp the intestine with the connecting part as a fulcrum.

[0007] Patent document 5 discloses a suture and ligation device for biological organisms, which is made of a bioabsorbable material and sutures and ligates biological tissues by heat deformation. The device is characterized in that the main body of the suture and ligation device is formed of a bioabsorbable material with a heat deformation start temperature of 45 degrees Celsius or higher and 100 degrees Celsius or lower.

[0008] Patent document 6 discloses a surgical device with a latching mechanism, comprising: a ligation clamp having a latching member and a retaining member, the retaining member having a proximal end and a distal end; an elastic hinge connecting the latching member and the retaining member at the proximal end; a latch having a protrusion connected to a shaft attached to the distal end of the latching member; a retainer receiving the latch and having a hole and a locking surface, the hole being adapted to lock the ligation clamp in a closed position at the distal end of the retaining member; and a port located at the distal end of the retaining member to allow visual inspection of the engagement of the latch and the retainer, wherein a portion of the latching member and a portion of the retaining member are contrasting colors, such that the presence of the latching member at the locked position is externally visible when the latching member is locked in place by the retaining member.

[0009] Patent document 7 discloses a surgical forceps, characterized in that each of a pair of arms is connected to one end of itself by a flexible, elastic member having a flexible end for separating the two arms toward the other arm, and each arm has an end opposite to the aforementioned end, the member allowing the two arms to move toward each other to become substantially parallel, one of the two arms having a locking, tightening portion at an intermediate location opposite to the other arm, and the other arm having a locking, tightening portion at an intermediate location opposite to the tightening portion of the first arm, the surgical forceps having a layer of elastic material on each of the opposing surfaces of the two tightening portions, the material being softer than the material of the tightening portions, the surgical forceps having a releasable ratchet unit located at the aforementioned opposite end of one arm, extending toward the other arm and capable of engaging with the other arm near the aforementioned opposite end of the other arm, for holding the two arms in fixed multiple opposing positions when the two arms move toward each other.

[0010] Patent document 8 discloses a clamp for closing the umbilical cord stump of a newborn, comprising: a pair of substantially straight first and second members; a spring unit connected to a first end of the members and applying force to the members in a mutually inclined position; a locking unit located on one of the members and holding the members substantially parallel and close relative to the force from the spring member; and an umbilical cord clamping and closing unit having at least one first protrusion and a corresponding first groove located on the first and second members and defined by the members.

[0011] Patent document 9 discloses a ligation clip comprising: a first jaw including a body having an inner surface and an outer surface defining a first clamping surface; a second jaw including a body having an inner surface and an outer surface defining a second clamping surface; and a hinge integrally formed with the first and second jaws, and including an inner hinge portion and an outer hinge portion, the inner hinge portion having an inner surface and an outer surface adjacent to the first and second clamping surfaces of the first and second jaws, the hinge being configured to facilitate pivoting of the first jaw relative to the second jaw between an open position and a clamping position, the inner surface of the inner hinge portion being defined by a plurality of bends.

[0012] Patent document 10 discloses a polymer surgical clamp comprising first and second curved leg members. The clamp is characterized in that the two leg members are joined at their proximal ends by an elastic hinge unit. Each leg member has an inner surface for vascular clamping and an outer surface back-to-back. The inner surface for vascular clamping of one leg member faces the inner surface for vascular clamping of the other leg member. The end of the first leg member becomes a flexible hook that bends toward the second leg member, and the end of the second leg member becomes a complementary locking portion relative to the hook. Thus, when the first and second leg members move from an open position to a closed position around the hinge unit, the hook bends around the end of the second leg member to lock the clamp in the closed position. The inner surface of the first leg member has a concave bending radius between the hinge unit and the hook, the inner surface of the second leg member has a convex bending radius between the hinge unit and its end, and the outer surface of the second leg member has a concave bending radius between the hinge unit and its end.

[0013] Existing technical documents

[0014] Patent documents

[0015] Patent Document 1: Japanese Patent Application Publication No. 2004-298501

[0016] Patent Document 2: Japanese Patent Publication No. 2015-523144

[0017] Patent Document 3: WO2019 / 039586A1

[0018] Patent Document 4: Japanese Patent Application Publication No. 2006-87671

[0019] Patent Document 5: Japanese Patent Application Publication No. 5-337123

[0020] Patent Document 6: Japanese Patent Application Publication No. 8-215201

[0021] Patent Document 7: Japanese Patent Publication No. 56-500242

[0022] Patent Document 8: US3705586A

[0023] Patent Document 9: Japanese Patent Application Publication No. 2020-025856

[0024] Patent Document 10: Japanese Patent Application Publication No. 1-146536 Summary of the Invention

[0025] The problem that the invention aims to solve

[0026] The objective of this invention is to provide a medical device suitable for ligation and other procedures that can be used to prevent various complications during partial resection of biological tissues (e.g., organs, viscera, etc.) such as the liver, pancreas, and blood vessels, with minimal invasiveness.

[0027] Technical solutions for solving the problem

[0028] In order to solve the above-mentioned problems, in-depth research was conducted, and as a result, the present invention comprising the following means was completed.

[0029] [1] A medical device having:

[0030] A flexible band with a distal and a proximal end;

[0031] A flexible first rod-shaped body, having a distal end and a proximal end; and

[0032] A flexible second rod-shaped body, having a distal end and a proximal end.

[0033] The distal end of the band is connected to the proximal end of the first rod-shaped body.

[0034] The distal end of the first rod-shaped body and the proximal end of the second rod-shaped body are connected by a connecting portion.

[0035] The band is more flexible than the first and second rod-shaped bodies.

[0036] The second rod and the belt have a locking mechanism that can securely connect the belt to the second rod at a desired position.

[0037] When the connection is secured by the locking mechanism, the proximal end of the first rod and the distal end of the second rod are connected via a portion of the band (specifically, the portion from the distal end of the band to the distal end of the second rod). The connection is curved, and a loop of the desired size can be formed by the first rod, the second rod, and the portion of the band.

[0038] The second rod also has the following mechanism: when fastened by the locking mechanism, the remaining part of the band (specifically, the part of the band from the distal end of the second rod to the proximal end) runs along the outer surface of the second rod from the distal end of the second rod toward the proximal end.

[0039] [2] The medical device according to [1], wherein the central portion of the inner surface of the first rod and / or the inner surface of the second rod is concave relative to the distal end and the proximal end.

[0040] [3] The medical device according to [1], wherein the central portion of the inner surface of the first rod and / or the second rod is convex inward relative to the distal end and the proximal end.

[0041] [4] The medical device according to any one of [1] to [3], wherein the mechanism for causing the remaining portion of the band to run along the outer surface of the second rod is a groove of a shape corresponding to the band provided on the outer surface of the second rod.

[0042] [5] The medical device according to any one of [1] to [4], wherein at least the distal end of the outer surface of the second rod-shaped body is convex outwardly curved.

[0043] [6] The medical device according to any one of [1] to [5], wherein the band, the first rod and the second rod are made of a biodegradable and absorbable polymer.

[0044] [7] The medical device according to any one of [1] to [6], wherein a layer of cushioning material is provided on the inner surface of the first rod and the inner surface of the second rod.

[0045] [8] The medical device according to any one of [1] to [6], wherein an inner band is provided on the inner surface of the first rod and the inner surface of the second rod.

[0046] [9] The medical device according to any one of [1] to [8], wherein the medical device is used for ligating biological tissue.

[0047]

[10] The medical device according to [9], wherein the medical device can be adjusted to not easily cause necrosis of biological tissues even when ligation is performed.

[0048]

[11] The medical device according to [9], wherein the medical device can be adjusted to maintain blood flow in biological tissues even when ligation is performed.

[0049]

[12] The medical device according to any one of [9] to

[11] , wherein the biological tissue to be ligated is an organ.

[0050]

[13] According to the medical device described in [9] to

[11] , the biological tissue to be ligated is the pancreas.

[0051]

[14] The medical device according to any one of [9] to

[11] , wherein the biological tissue to be ligated is the body or tail of the pancreas.

[0052]

[15] The medical device according to any one of [9] to

[11] , wherein the biological tissue to be ligated is the head of the pancreas.

[0053]

[16] The medical device according to any one of

[13] to

[15] , wherein the medical device is adjustable to prevent pancreatic fistula even when ligation is performed.

[0054]

[17] According to the medical device described in [9], the biological tissue to be ligated is the liver.

[0055]

[18] According to the medical device described in [9], the biological tissue to be ligated is a blood vessel.

[0056] Invention Effects

[0057] The medical device of the present invention can be used to prevent various complications in the partial resection of biological tissues (e.g., organs, etc.) such as the liver, pancreas, and blood vessels, and is less invasive and suitable for ligation of biological tissues. Attached Figure Description

[0058] Figure 1 This is a perspective view illustrating an example of the medical device of the present invention.

[0059] Figure 2 This is a perspective view showing another example of the medical device of the present invention.

[0060] Figure 3 This is a diagram illustrating an example of the state when the first and second rods are closed and approximately parallel.

[0061] Figure 4 This is another example of the state when the first and second rods are closed and approximately parallel.

[0062] Figure 5 This is another example of the state when the first and second rods are closed and approximately parallel.

[0063] Figure 6 This is another example of the state when the first and second rods are closed and approximately parallel.

[0064] Figure 7 This is a partial conceptual diagram showing an example of the state in which the remaining part of the band is inserted from the proximal end 1p side along the outer surface of the distal end 3d of the second rod into the part immediately in front of the pawl 5, as viewed from the distal side to the proximal side of the second rod.

[0065] Figure 8 It indicates viewing from the side. Figure 7 A partial concept diagram of an example of a state.

[0066] Figure 9This is a partial conceptual diagram showing an example of the state in which the remaining part of the band is inserted into the pawl 5 from the proximal end 1p side along the outer surface of the distal end 3d of the second rod and locked, as viewed from the distal side to the proximal side of the second rod.

[0067] Figure 10 It indicates viewing from the side. Figure 9 A partial concept diagram of an example of a state.

[0068] Figure 11 This is a side view showing an example of a hole formed in the second rod-shaped body.

[0069] Figure 12 Viewed from the outer surface side Figure 11 Diagram of the hole.

[0070] Figure 13 This is a perspective view showing another example of the medical device of the present invention.

[0071] Figure 14 It is a different perspective. Figure 13 The diagram shows a three-dimensional view of the main parts of the medical device.

[0072] Figure 15 This is a perspective view of the main part of another example of the medical device of the present invention.

[0073] Figure 16 It means in Figure 15 A three-dimensional view of the main part of the medical device in a locked state.

[0074] Figure 17 It means Figure 16 A cross-sectional view of the main part of the locking mechanism of the medical device shown.

[0075] Figure 18 This is a perspective view showing another example of the second rod-shaped body in the medical device of the present invention.

[0076] Figure 19 It means Figure 18 A cross-sectional view of the locking mechanism of the second rod-shaped body shown.

[0077] Figure 20 It means being able to... Figure 18 A perspective view of an example of the first rod and band in the second rod assembly shown.

[0078] Figure 21 It means to Figure 20 The distal end of the first rod shown is Figure 18 The diagram shows the state in which the proximal end of the second rod is connected and the belt is housed in a mechanism that allows the belt to run along the outer surface of the second rod.

[0079] Figure 22 It means localized destruction. Figure 20 The diagram shows a state in which the distal end of the first rod is connected to the proximal end of the second rod in another example of the medical device of the present invention, and the strap is housed in the locking mechanism of the second rod.

[0080] Figure 23 This is a perspective view showing another example of the medical device of the present invention.

[0081] Figure 24 It is a different perspective. Figure 23 A three-dimensional diagram of the main parts of the time.

[0082] Figure 25 This is a sectional view of the main part showing the state in which the belt is housed in the locking mechanism of the second rod and locked.

[0083] Figure 26 It means Figure 23 A cross-sectional view of another state of the medical device shown.

[0084] Figure 27 This is a perspective view showing another example of the medical device of the present invention.

[0085] Figure 28 It means Figure 27 The diagram shows a locking mechanism in a medical device.

[0086] Figure 29 It means in Figure 27 The medical device shown is a cross-sectional view of the state in which the band is housed in the locking mechanism of the second rod and tightened.

[0087] Figure 30 This is a perspective view showing another example of the medical device of the present invention.

[0088] Figure 31 It is a different perspective. Figure 30 A three-dimensional diagram of the main parts of the time.

[0089] Figure 32 This is a perspective view showing another example of the medical device of the present invention.

[0090] Figure 33 It is a different perspective. Figure 32 A three-dimensional image of the time.

[0091] Figure 34 It means Figure 32 The diagram shows the connector 4a of the medical device.

[0092] Figure 35 This is a diagram showing another example of the connecting part 4a.

[0093] Figure 36 This is a diagram showing another example of the connecting part 4a.

[0094] Figure 37 This is a diagram showing another example of the connecting part 4a.

[0095] Figure 38 This is a diagram illustrating an example of a mechanism that causes the belt to move along the outer surface of the second rod.

[0096] Figure 39 This is a diagram illustrating an example of a mechanism that causes the belt to move along the outer surface of the second rod.

[0097] Figure 40 This is a diagram illustrating an example of a mechanism that causes the belt to move along the outer surface of the second rod.

[0098] Figure 41 This is a diagram illustrating an example of a mechanism that causes the belt to move along the outer surface of the second rod. Detailed Implementation

[0099] Embodiments of the present invention will be described with reference to the accompanying drawings.

[0100] The medical device of the present invention has a belt body 1, a first rod-shaped body 2, and a second rod-shaped body 3.

[0101] The band 1 is an elongated, flexible, band-shaped member having a distal end 1d and a proximal end 1p. The band is preferably made of medical materials, more preferably of biocompatible polymers, and even more preferably of biodegradable and absorbable polymers. The band can be formed from a block or from fibers such as mesh, woven fabric, or nonwoven fabric.

[0102] The first rod 2 is an elongated, flexible rod-shaped member having a distal end 2d and a proximal end 2p. The second rod 3 is an elongated, flexible rod-shaped member having a distal end 3d and a proximal end 3p. The first and second rods are preferably made of medical materials, more preferably of biocompatible polymers, and even more preferably of biodegradable and absorbable polymers. The first and second rods can be formed from blocks or from fibers such as mesh, woven fabric, or nonwoven fabric, but to prevent bending, they are preferably formed from blocks.

[0103] Furthermore, the medical device of the present invention can be obtained, for example, by molding the various parts of a polymer, which is a medical material, into the shape of a known resin molding method. Examples of polymers include lactic acid polymers, lactic-glycolic acid polymers, trimethylene carbonate polymers, dioxane polymers, polyethylene glycol polymers, and lactone polymers.

[0104] In addition, there are no particular restrictions on the length, thickness, elastic modulus, etc. of the band, the first rod-shaped body, and the second rod-shaped body. For example, they can be appropriately set according to the shape and size of the biological tissue to be disposed of.

[0105] In the medical device of the present invention, the distal end of the band 1 and the proximal end of the first rod 2 are connected via a connecting portion 4b. The distal end of the band and the proximal end of the first rod are preferably connected in an inwardly recessed manner. The connecting portion 4b can be, for example, a short band-like member or a hinge member. Furthermore, the connecting portion 4b can also be designed to allow separation of the first rod 2 from the band 1. The connecting portion 4b is preferably made of a medical material, more preferably of a biocompatible polymer, and even more preferably of a biodegradable and absorbable polymer.

[0106] In the medical device of the present invention, the distal end of the first rod-shaped body 2 and the proximal end of the second rod-shaped body 3 are connected via a connecting portion 4a. Preferably, the distal end of the first rod-shaped body 2 and the proximal end of the second rod-shaped body 3 are connected inwardly recessed. The connecting portion 4a can be, for example, a short strip-shaped member or a hinge member. Furthermore, the connecting portion 4a can also be configured to allow separation of the first rod-shaped body 2 and the second rod-shaped body 3.

[0107] The connecting part 4a can also be like this Figure 29 As shown, it is formed into a shape that is thinner than the proximal end 3p of the second rod 3 and the distal end 2d of the first rod 2, as shown. Figure 34 The lanyard ring shape shown, or as... Figure 35 , 36 Or, as shown in diagram 37, a peninsula portion 12 is provided on the inner side. The connecting portions 4a of these shapes allow the gap between the first rod-shaped body and the second rod-shaped body to be more parallel or tightly connected, enabling more uniform tightening pressure applied to the biological tissue and reducing the risk of the connecting portion 4a trapping the biological tissue. The peninsula portion is particularly effective in reducing the risk of trapping the biological tissue.

[0108] The connecting part 4a is preferably made of medical material, more preferably of biocompatible polymer, and even more preferably of biodegradable and absorbable polymer.

[0109] Furthermore, the proximal end of the belt and the distal end of the second rod are preferably not bound anywhere when not fastened by the locking mechanism described later. If the proximal end of the belt is provided with ribs 8 or the like to make its rigidity higher than that of the distal end of the belt, buckling can be suppressed and it is easier to insert into the locking mechanism, which is therefore preferred.

[0110] Furthermore, the belt is more easily flexed than the first and second rods. There are no particular limitations on the method of adjusting the ease of flexing; for example, when the belt, the first rod, and the second rod are made of the same material, this can be achieved by adjusting the thickness or diameter. By increasing the thickness of a portion, such as rib 8, the ease of flexing can be reduced. Additionally, as... Figure 2 As shown, by providing multiple grooves (e.g., grooves between ratchet teeth 6) on the outer surface of the belt in a direction orthogonal to the direction of bending, the flexibility can be improved.

[0111] The second rod-shaped body 3 and the belt body 1 have a locking mechanism. The locking mechanism can securely connect the belt body to the second rod-shaped body at the desired position.

[0112] The locking mechanism consists of a portion located on the belt body and a portion located on the second rod-shaped body having a structure capable of being fastened to that portion. Examples of locking mechanisms include a combination of a pawl 5 provided on the second rod-shaped body and a plurality of ratchet teeth 6 arranged along the length direction of the belt body, a combination of at least one recess provided on the second rod-shaped body and a plurality of protrusions arranged along the length direction of the belt body, or a combination of at least one protrusion provided on the second rod-shaped body and a plurality of recesses arranged along the length direction of the belt body.

[0113] Examples of protrusions in a locking mechanism include pins and hooks. Examples of recesses include holes, rings, narrowing sections, and notches. Multiple protrusions or recesses on the belt body can be beaded protrusions or recesses formed by connecting spherical or annular parts, or they can be serrated protrusions or recesses extending to both sides, or they can be ladder-shaped protrusions or recesses.

[0114] To prevent it from falling out of the inserted recess, the protrusion of the locking mechanism preferably has a barb. The barbed protrusion can be an inverted L-shaped protrusion, a T-shaped protrusion, a cross-shaped protrusion, etc. The multiple recesses provided on the belt body can be made of mesh from fabric or netting, as long as the protrusion can pass through. As a combination of hook and loop, for example, Velcro can be used.

[0115] A ratchet, as an example of a locking mechanism, is one of the mechanisms used to restrict the direction of movement to one direction. It is fastened by engaging the ratchet tooth 6 with the pawl 5. The pawl can be movable or fixed. When the ratchet tooth is engaged with the movable pawl, the engagement can be easily disengaged. When the ratchet tooth is engaged with the fixed pawl, the engagement is difficult to disengage. In the figure, only one movable pawl is provided, but when both a fixed and movable pawl are provided, the belt is first locked using the movable pawl. When the tension force on the biological tissue is too large, the engagement is disengaged to loosen the tension. Then, when the tension force is fixed, the fixed pawl can be engaged to maintain the position of the belt.

[0116] When the connection is secured by the locking mechanism, the proximal end of the first rod and the distal end of the second rod are connected via a portion of the belt (specifically, the portion from the distal end of the belt to the distal end of the second rod). The connecting portion 4a is curved and a loop can be formed by the first rod, the second rod, and a portion of the belt. The loop can be fan-shaped or polygonal.

[0117] A portion of the band connecting the proximal end of the first rod to the distal end of the second rod can have its length changed by altering the position of the fastening connection, thereby changing the size of the loop. Thus, the loop can be made to the desired size and the desired tightening force according to the size of the object being ligated.

[0118] The inner surfaces of the first and second rods can be independent of each other; they can be straight between the distal and proximal ends, concave between the distal and proximal ends, or convex between the distal and proximal ends. Specifically, examples include: Figure 3 As shown, the inner surfaces of both the first and second rods exhibit an inwardly convex curvature between their distal and proximal ends; Figure 4 As shown, the inner surfaces of both the first and second rods exhibit an inwardly concave curvature between their distal and proximal ends; Figure 5 As shown, the inner surface of the first rod-shaped body 2 is concave inward between the distal and proximal ends, and the inner surface of the second rod-shaped body 3 is convex inward between the distal and proximal ends; and as shown... Figure 6 As shown, the inner surface of the first rod-shaped body 2 is convex inward between its distal and proximal ends, and the inner surface of the second rod-shaped body 3 is concave inward between its distal and proximal ends. From the viewpoint of enabling successful ligation of biological tissues, the inner surfaces of the first and second rod-shaped bodies are preferably concave inward between their distal and proximal ends (see reference). Figure 4 ), or the distal and proximal ends of both sides bend inward in a convex shape (see reference). Figure 3 More preferably, the distal and proximal ends of both sides are concave inward.

[0119] To increase the friction between the ligation material and the biological tissue and prevent slippage, the inner surfaces of the first and second rods can be rough surfaces, or surfaces with raised lines 13, concave lines 11, or grids, or surfaces with multiple raised or concave points. If raised strips are provided parallel to the length direction near the edges of the inner surfaces of the first and second rods, the prevention of digestive fluid leakage and hemostasis can be improved.

[0120] Furthermore, to prevent damage to biological tissue when binding it, a layer of cushioning material can be provided on the inner surfaces of the first and second rods. Examples of cushioning materials include soft elastomers such as rubber, foamed elastomers such as sponge, and nonwoven or woven fabrics such as felt. The cushioning material is preferably composed of medical materials, more preferably of biocompatible polymers, and even more preferably of biodegradable and absorbable polymers.

[0121] When ligating biological tissue, a gap is created between the first and second rod-shaped bodies, which are roughly parallel. The biological tissue may sometimes enter this gap. Therefore, to prevent this, the band-shaped member (inner band 10) can be installed around the area of ​​the biological tissue to be ligated, or near the inner side of the connecting portion 4a or 4b (see reference). Figure 2 The inner pack is preferably made of medical materials, more preferably of biocompatible polymers, and even more preferably of biodegradable and absorbable polymers. The inner pack can be formed from a bulk material or from fibers such as nonwoven fabrics, woven fabrics, or meshes. Additionally, Figure 2 The unrestrained end portion of the inner band 10 shown can be fixed by clamping it between the second rod and the biological tissue during ligation, or by setting an installation structure corresponding to the inner band on the second rod and installing it on the installation structure.

[0122] The second rod-shaped body 3 also has the following mechanism: when the connection is fastened by the locking mechanism, the remaining part of the belt body 1 (specifically, the part of the belt body from the part connected to the distal end of the second rod-shaped body to the proximal end) is moved along the outer surface of the second rod-shaped body from the distal end to the proximal end.

[0123] Examples of mechanisms for guiding the belt along the outer surface of the second rod include: a belt loop 7 provided on the outer surface of the second rod for insertion of the belt; a groove 9 on the outer surface of the second rod with a shape corresponding to the belt; and holes, rings, hooks, and barbed pins on the outer surface of the second rod corresponding to barbed pins, hooks, rings, and holes provided on the inner surface of the belt. A pawl may also be provided on the belt loop 7 to secure the belt. Furthermore, to allow the belt 1 to fold back smoothly along the outer surface of the second rod 3 from its distal end, the outer surface of the second rod is preferably convex outwardly curved, at least near the distal end. This configuration is preferably shaped such that the belt 1 fits snugly along the outer surface of the second rod when fastened to the locking mechanism. When the band 1 is tightly locked as described above, the distance from the distal end 1d of the band 1 to the portion where the band 1 connects with the distal end of the second rod does not increase, thus providing a stable tightening force on the biological tissue and preventing loosening. Furthermore, this structure guides the direction of the ratchet on the band 1 relative to the pawl on the second rod towards an orientation that ensures reliable engagement. This structure prevents the band 1 from being oriented in an unsuitable direction for engagement, thus reducing the risk of pawl breakage. For example, Figures 7-10 This indicates the state up to the point where the belt body 1 is inserted into the pawl 5 and locked. For example... Figure 7 As shown, the distal end 3d of the second rod-shaped body has a groove 9 of a size comparable to the width of the belt 1, provided on both sides by dikes 9c. The groove 9 guides the belt in the appropriate direction and prevents lateral deviation. Additionally, as... Figure 8 As shown, the outer surface near the distal end 3d of the second rod-shaped body is curved outwardly convex. When the belt 1 is passed through the portion of the movable pawl 5 from its proximal end 1p side, the belt 1 is received in the groove 9 along the outer surface of the second rod-shaped body. Figure 9 , Figure 10 ).

[0124] As a mechanism for securing the belt along the outer surface of the second rod, loops and hooks, holes and hooks can be used. Loops and hooks are components where loops (fine loops) and hooks are paired, and the hook's protrusion is wrapped around the loop for fixation. When unwrapped, the hook can be separated from the loop. In this invention, hooks and loops can be provided on the inner surface of the belt and the outer surface of the second rod respectively, so that they are paired, and the belt is fixed along the outer surface of the second rod by the loops and hooks. Holes and hooks are components where holes and hooks are paired, and the hook is inserted into the hole for fixation. The hook's protrusion hooks onto the edge of the hole and is not easily dislodged. When the hook is unhooked, the hook can be separated from the hole. In this invention, hooks can be provided on the inner surface of the belt, and holes can be provided on the outer surface of the second rod, and the belt is fixed along the outer surface of the second rod by the holes and hooks. Furthermore, the hole does not need to be a through hole. As a specific example, a pair of holes (orifice: hole) 32 and hooks 31 can be cited. Figure 38 ), the pair of hooks 33 and 31 ( Figure 39 ), the pair of loop 34 and hook 31 ( Figure 40 ) etc. Hook 31 can also be a pin 31' with a hook shape at the head ( Figure 41 ).

[0125] The placement of loops and hooks (fasteners), holes and hooks on the second rod is not particularly limited as long as it is suitable for a portion along the outer surface of the second rod. For example, they can be placed at... Figure 21 The outer surface of the second rod-shaped body clamped by the dam 9c, the outer surface of the second rod-shaped body located at that position in place of the loop 7, and the outer surface of the second rod-shaped body between the pawl 5 and the loop 7, etc. The locations for the loops and hooks (fasteners), holes and hooks on the belt body can be located on the inner surface of the belt body next to the ratchet row, or on the inner surface of the belt body located at the position where a part of the ratchet has been removed, etc.

[0126] Figure 13 and Figure 14 This is a diagram illustrating another example of the medical device of the present invention. Figure 13 and Figure 14 The medical device shown has concave lines on the inner surfaces (the surfaces in contact with biological tissue) of the first and second rods, parallel to their length. Biological tissue bites into these concave lines, reliably achieving ligation and providing anti-slip effects.

[0127] Figures 15-17 The medical device of the present invention shown has a pawl 5 disposed inwardly on the bulge at the distal end 3d side of the second rod-shaped body 3. The second rod-shaped body 3 is slightly longer than the first rod-shaped body 2.

[0128] Figure 18 or Figure 19 This is a diagram showing the second rod-shaped body 3 constituting a medical device as an example of the present invention. Figure 20 It means being able to... Figure 18 or Figure 19 The diagram shows the first rod-shaped body 2 and the belt body 1 assembled with the second rod-shaped body 3. A hook 4a' is provided at the proximal end 3p of the second rod-shaped body 3, and a shaft 4a' capable of engaging with the hook 4a' is provided at the distal end 2d of the first rod-shaped body 2. The engagement of the hook 4a' with the shaft 4a' forms a connecting portion 4a. In this embodiment, a ratchet 6 is provided inwardly on the belt body 1, and a pawl is provided outwardly on the bulge on the distal end 3d side of the second rod-shaped body 3 and inside the belt loop 7. Figure 21 Or as shown in Figure 22, the ratchet 6 can engage with the pawl 5 of the bulge located on the distal end 3d side of the second rod-shaped body 3. Furthermore, the belt body (1) can be passed through the belt loop 7 to engage the ratchet (6) with the pawl inside the belt loop 7. Additionally, in Figure 22 In the middle, the distal part of the band and the ratchet (in Figure 22 In the middle, marked as "1" and "6" respectively) and the proximal part of the band and the ratchet (in Figure 22 In the text, “(1)” and “(6)” are marked as “(1)” and “(6)” respectively. They were originally connected, but their descriptions have been omitted.

[0129] Figures 23-26 The medical device shown has a pawl 5 at the distal end 3d of the second rod-shaped body 3. There are no ratchet teeth 6 near the distal end 1d. Even when the band is pulled to a position without ratchet teeth, the pawl 5 will return to the position closest to the distal end 1d and engage when the pull on the band is reduced. This allows for setting a tightening limit. Furthermore, the device is configured such that there is a gap between the bulge at the distal end 3d and the main body of the second rod-shaped body. When the bulge is pressed towards the main body of the second rod-shaped body to narrow the gap, the pawl disengages from the ratchet teeth.

[0130] Figures 27-29 The medical device shown is configured such that there is a gap between the ratchet located near the distal end 1d of the belt and the belt body, so that the engagement is not easily disengaged even if the belt accidentally loosens. Figure 29 In the medical device shown, the connecting portion 4a is formed to be thinner than the proximal end 3p of the second rod 3 and the distal end 2d of the first rod 2.

[0131] Figures 30-31 The distal end 3d of the second rod-shaped body 3 of the illustrated medical device is offset from the proximal end 2p of the first rod-shaped body 2 so that the strap 1 is not embedded in the groove 9, thus preventing accidental engagement of the pawl and the ratchet teeth. Because the connecting portion 4a is flexible, when the distal end 3d of the second rod-shaped body 3 and the proximal end 2p of the first rod-shaped body 2 are configured such that the strap 1 is embedded in the groove 9, the pawl and the ratchet teeth can engage.

[0132] Figures 32-33The medical device shown, in addition to changing the shape of the first rod-shaped body and the second rod-shaped body, forms the connecting part 4a as follows: Figure 34 The cross-section shown is a flexible, one-piece molded component with a randall-shaped structure, and has the same... Figures 30-31 The medical device shown is from the same institution. Figure 32 In the medical device shown, the connecting portion 4a, which is formed in the shape of a lanyard ring, is thinner than the proximal end 3p of the second rod 3 and the distal end 2d of the first rod 2. The proximal end 3p of the second rod 3 and the distal end 2d of the first rod 2 are connected to the cut portion of the lanyard ring.

[0133] The medical device of the present invention can be used, for example, for ligation of biological tissues. There are no particular limitations on the biological tissue, as long as the ligation is effective; for example, it can be used for organs, and is particularly suitable for viscera. Examples of such organs include blood vessels, lymphatic vessels, thoracic ducts, bile ducts, fallopian tubes, vagina, ureter, urethra, vas deferens, trachea, and bronchi, which have tubular structures. Examples of viscera include the pancreas, liver, gallbladder, spleen, kidney, bladder, uterus, ovary, testis, lungs, heart, thyroid gland, esophagus, stomach, duodenum, small intestine, large intestine, and lymph nodes.

[0134] The medical device of 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.

[0135] The medical device of the present invention can be preferably used for ligation of the liver, more preferably for ligation of the liver parenchyma when there is liver bleeding, and can also be used to reduce liver bleeding during liver resection surgery.

[0136] The medical device of the present invention can be preferably used for ligation of the spleen, more preferably for ligation of the splenic parenchyma when there is splenic bleeding, and can also be used to reduce splenic bleeding during splenectomy.

[0137] The medical device of the present invention can be preferably used for ligation of the kidney, more preferably for ligation of the renal parenchyma when there is renal bleeding, and can be used to reduce renal bleeding during nephrectomy.

[0138] Because biological tissues, especially organs, are easily deformed and fragile, existing ligation devices used for ligating their severed ends typically employ a shape similar to the cut surface to minimize tissue damage caused by ligation, such as tissue necrosis due to obstruction of blood flow, in order to apply as even pressure as possible to the cut surface of the organ. For example, in the case of pancreatic ligation, a roughly circular ligation device has historically been used.

[0139] However, when a biological tissue contains tubular structures, the opening of the lumen will be exposed at the cut surface when the tissue is cut. Furthermore, preventing leakage of fluids such as digestive juices that could potentially damage surrounding tissues within the lumen becomes a challenge when ligating biological tissues. A pancreatic fistula is an example.

[0140] However, in conventional, roughly circular ligation devices, when ligation is performed loosely to avoid excessive pressure on the tissue, the openings of luminal structures in the cut surface of the tissue cannot be adequately and effectively blocked. On the other hand, if the occlusion of luminal structures is emphasized, excessive pressure is applied to the tissue, leading to significant problems of blood flow obstruction and subsequent tissue necrosis. In other words, a compromise must be struck between minimizing tissue damage caused by ligation and preventing leakage of fluid from the openings of luminal structures in the cut surface of the tissue.

[0141] As described above, the medical device of the present invention comprises a first rod-shaped body and a second rod-shaped body having specific shapes and specific flexibility, and a locking mechanism adjustable to properly maintain the distance between the proximal end of the first rod-shaped body and the distal end of the second rod-shaped body during ligation. Thus, although the structure does not apply pressure evenly from around the biological tissue, it can be adjusted to minimize blood flow obstruction within the biological tissue caused by pressure, and consequently, necrosis. Furthermore, according to the medical device of the present invention, even if a lumen structure exists within the biological tissue, its opening can be effectively blocked.

[0142] That is, the medical device of the present invention can simultaneously reduce tissue damage caused by ligation and suppress leakage of fluid from the opening of the lumen structure in the cut surface of biological tissue. In addition, by adjusting the force of ligation of the pancreas, the medical device of the present invention can be fixed to the pancreas while maintaining the opening of the lumen structure, and the digestive tract and tissues can be sutured during pancreaticodigestive tract anastomosis as described later.

[0143] In addition, such as Figure 11 and Figure 12 As shown, the second rod-shaped body 3 and the first rod-shaped body 2 of the medical device of the present invention may have holes (sometimes also called buttonholes, eyelet holes) 25 arranged in at least one row along the length direction. Sutures can be passed through the holes 25 to suture the digestive tract, tissues, etc., to the severed ends of digestive organs. When the medical device of the present invention with holes 25 is fixed to the pancreas after pancreatic head and duodenum resection, sutures can be installed in the pancreas simply by passing a suture needle through the holes 25, without needing to puncture the pancreatic parenchyma. Furthermore, the pancreas with sutures installed can be sutured to other organs such as the intestines and stomach (e.g., pancreatic-digestive tract anastomosis).

[0144] The medical device of the present invention is not limited to the embodiments shown in the accompanying drawings. Medical devices that change the shape, size, color, or material of the above-mentioned components, or medical devices that add known or conventional components other than the above-mentioned components, are also included in the technical scope of the present invention.

[0145] Label Explanation

[0146] 1: Band body;

[0147] 2: First rod-shaped body;

[0148] 3: Second rod-shaped body;

[0149] 4a: The connecting part between the first rod-shaped body and the second rod-shaped body;

[0150] 4b: The connection between the belt and the first rod-shaped body;

[0151] 5: Claws;

[0152] 6: Ratchets;

[0153] 7: Belt;

[0154] 8: Ribs;

[0155] 9: slot;

[0156] 9c: dike;

[0157] 10: Inner bag;

[0158] 11: Anti-slip section (concave lines);

[0159] 12: Peninsula region;

[0160] 13: Convex lines;

[0161] 25: Hole;

[0162] 1p: the proximal end of the belt;

[0163] 1d: The distal end of the band;

[0164] 2p: proximal end of the first rod;

[0165] 2d: The distal end of the first rod-shaped body;

[0166] 3p: proximal end of the second rod;

[0167] 3d: The distal end of the second rod-shaped body;

[0168] 4a': Hook;

[0169] 4a”: Axis;

[0170] 31: Hook;

[0171] 31': Pin;

[0172] 32: Hole;

[0173] 33: Opposite hook;

[0174] 34: Terry cloth;

[0175] 3': The outer wall of the second rod-shaped body.

Claims

1. A medical device having: A flexible band with a distal and a proximal end; A flexible first rod-shaped body, having a distal end and a proximal end; and A flexible second rod-shaped body, having a distal end and a proximal end. The distal end of the band is connected to the proximal end of the first rod-shaped body. The distal end of the first rod-shaped body and the proximal end of the second rod-shaped body are connected by a connecting portion. The band is more flexible than the first and second rod-shaped bodies. The second rod and the belt have a locking mechanism that can securely connect the belt to the second rod at a desired position. When the connection is secured by the locking mechanism, the proximal end of the first rod and the distal end of the second rod are connected via a portion of the belt. The connection is bent, and a loop of the desired size can be formed by the first rod, the second rod, and a portion of the belt. The second rod also has the following mechanism: when fastened by the locking mechanism, the remaining part of the belt moves along the outer surface of the second rod from the distal end toward the proximal end.

2. The medical device according to claim 1, wherein, The central portion of the inner surface of the first rod and / or the second rod is concave inward relative to the distal and proximal ends.

3. The medical device according to claim 1, wherein, The central portion of the inner surface of the first rod and / or the second rod is convex inward relative to the distal and proximal ends.

4. The medical device according to any one of claims 1 to 3, wherein, The mechanism that allows the remaining portion of the belt to run along the outer surface of the second rod is a groove on the outer surface of the second rod that corresponds to the shape of the belt.

5. The medical device according to any one of claims 1 to 3, wherein, The outer surface of the second rod-shaped body is bent outward at least near the distal end.

6. The medical device according to any one of claims 1 to 3, wherein, The band, the first rod-shaped body, and the second rod-shaped body are composed of biodegradable and absorbable polymers.

7. The medical device according to any one of claims 1 to 3, wherein, A layer of buffer material is provided on the inner surface of the first rod and the inner surface of the second rod.

8. The medical device according to any one of claims 1 to 3, wherein, Inner bands are provided on the inner surfaces of the first rod and the second rod.

9. The medical device according to any one of claims 1 to 3, wherein, The medical device is used for ligating biological tissues.

10. The medical device according to claim 9, wherein, The medical device has the following structure: it can change the position of the fastening connection by the locking mechanism in a way that does not easily cause necrosis of biological tissues even when ligation is performed.

11. The medical device according to claim 9, wherein, The medical device has the following structure: it can change the position of the fastening connection via a locking mechanism in a way that maintains blood flow within the biological tissue even when ligation is performed.

12. The medical device according to claim 9, wherein, The biological tissue to be ligated is an organ.

13. The medical device according to claim 9, wherein, The organ to be ligated is the pancreas.

14. The medical device according to claim 9, wherein, The biological tissue to be ligated is either the body or tail of the pancreas.

15. The medical device according to claim 9, wherein, The organ to be ligated is the head of the pancreas.

16. The medical device according to claim 13, wherein, The medical device has the following structure: it is able to change the position of the fastening connection via a locking mechanism in a manner that will not cause pancreatic fistula even if ligation is performed.

17. The medical device according to claim 9, wherein, The organ tissue to be ligated is the liver.

18. The medical device according to claim 9, wherein, The biological tissue to be ligated is a blood vessel.

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