阅读说明：本技术 脏器切离部残端固定夹具 (Fixing clamp for residual end of organ excision part ) 是由 马场秀夫 山下洋市 井嶋博之 于 2020-03-17 设计创作，主要内容包括：本发明涉及脏器切离部残端固定夹具。本发明的目的在于提供一种将在切离胰腺的一部分的手术中产生的胰腺切离部残端固定的装置。通过本发明,提供了一种聚合物制手术用夹具,由第一臂部、第二臂部、以及将第一及第二臂部连结的弹性铰链部构成,其中,上述手术用夹具构成为两臂部在各自的基部与上述弹性铰链部连结,第一臂部具有凸状的外侧面和夹持胰腺的凹状的内侧面,第二臂部具有凸状或者平面状的外侧面和夹持胰腺的凹状或者平面状的内侧面,第一臂部的末端形成向第二臂部弯曲的挠曲性钩部,在闭锁位置,第二臂部的末端进入上述弯曲的钩部的内侧并与钩部卡合,从而将夹具锁止在闭锁位置。(The invention relates to a fixing clamp for the stump of a viscera excision part. The present invention is directed to a device for fixing a pancreas resection stump generated in a surgery for resecting a portion of a pancreas. The present invention provides a polymer surgical clip comprising a first arm, a second arm, and an elastic hinge portion connecting the first and second arms, wherein the surgical clip is configured such that the two arms are connected to the elastic hinge portion at respective base portions, the first arm has a convex outer surface and a concave inner surface for pinching a pancreas, the second arm has a convex or planar outer surface and a concave or planar inner surface for pinching a pancreas, a distal end of the first arm is formed with a flexible hook portion which is bent toward the second arm, and the distal end of the second arm enters the inside of the curved hook portion and engages with the hook portion at a locking position, thereby locking the clip at the locking position.)

1. A polymer surgical clip for pancreatectomy, comprising a first arm, a second arm, and an elastic hinge portion connecting the first arm and the second arm, wherein the first arm and the second arm are connected to the elastic hinge portion at their respective base portions, the first arm has a convex outer surface and a concave inner surface for pinching a pancreas, the second arm has a convex or planar outer surface and a concave or planar inner surface for pinching a pancreas, the inner surface of the first arm and the inner surface of the second arm are opposed to each other, and a distal end of the first arm forms a flexible hook portion which is curved toward the second arm, whereby, in a closed position, the distal end of the second arm enters the inside of the curved hook portion and engages with the hook portion, thereby locking the clip in the closed position,

the surgical clip is configured such that the first arm and the second arm maintain substantially the same shape in the open position and the closed position, and a space is created between the inner surfaces of the first arm and the second arm that grip the pancreas.

2. The polymer-made surgical clip according to claim 1,

the second arm has a convex outer surface and a concave inner surface for pinching the pancreas, and the inner surface of the first arm and the inner surface of the second arm face each other to form an opposite curved surface.

3. The polymer-made surgical clip according to claim 1 or 2,

in the closed position, the maximum distance between the inner surface of the first arm portion and the inner surface of the second arm portion is greater than the thickness between the inner surface and the outer surface of the first arm portion or the second arm portion.

4. The polymer-made surgical clip according to any one of claims 1 to 3,

the thickness between the inner side surface and the outer side surface of the first arm portion is substantially the same as the thickness between the inner side surface and the outer side surface of the second arm portion.

5. The polymer-made surgical clip according to any one of claims 1 to 4,

the radius of curvature of the concave inner surface of the first arm portion is substantially equal to the radius of curvature of the concave inner surface of the second arm portion.

6. The polymer-made surgical clip according to any one of claims 1 to 5,

the first arm portion and the second arm portion each have one or two protruding portions extending in the lateral direction.

7. The polymer-made surgical clip according to any one of claims 1 to 6,

the inner surface of the first arm portion in the vicinity of the base portion and the inner surface of the second arm portion in the vicinity of the base portion each have a raised portion.

8. The polymer-made surgical clip according to any one of claims 1 to 7,

the inner surface of the first arm portion and/or the inner surface of the second arm portion are/is a surface having an uneven surface or a surface having a plurality of projections.

9. The polymer-made surgical clip according to any one of claims 1 to 8,

the shape memory is performed by the shape of the whole clamp at the locking position.

10. The polymer-made surgical clip according to any one of claims 1 to 9,

the polymer surgical jig is composed of a bioabsorbable polymer.

11. The polymer-made surgical clip according to any one of claims 1 to 10,

the above-mentioned surgical jig made of polymer is used for fixing the excised stump of a pancreas excised by pancreatectomy.

12. The polymer-made surgical clip according to claim 11,

the pancreas is held at a pressure of at least 4kPa when the incised part stump of the pancreas is fixed.

13. The polymer-made surgical clip according to any one of claims 1 to 12,

the polymer-made surgical jig is used for a surgical method selected from the group consisting of a pancreatectomy, a pancreaticoduodenal resection, a pancreatic tumor nucleation, and a pancreatectomy.

Technical Field

The present invention relates to a jig for fixing a stump of an organ resection part, and a method for fixing a stump of an organ resection part using the jig.

Background

A pancreatic fistula occurring after an excision of the pancreas is a phenomenon in which pancreatic juice leaks out continuously or intermittently. As a radical treatment of a tumor in the tail of the pancreas, a pancreatectomy is performed, but a pancreatic fistula in which pancreatic juice (digestive enzymes) leaks from the pancreatic stump may occur after the tail of the pancreas is excised, which is one of the complications that has not yet been solved. Pancreatic fistulas sometimes dissolve surrounding tissues (arteries, etc.) and cause massive bleeding, which may be fatal. The occurrence of post-operative pancreatic fistulas is caused by a pancreatectomy in about 30% of the time, and is also responsible for life-threatening complications.

In the pancreatectomy, the stump main pancreatic duct is excised by ligation, and the parenchyma of the pancreas on the side of the pancreaticotomy body is closed and excised to prevent leakage of pancreatic juice.

In order to occlude the pancreatic parenchyma on the side of the excised corpus pancreaticosa in the pancreaticotomy, various techniques are used. Examples thereof include suturing, teres ligament repair (patch), fibrin sealant, TachoSil (registered trademark) repair, and pancreatic duct/jejunal (pancreatic duct/stomach) anastomosis, but any technique is suitable. With the increase of the pancreatectomy using a laparoscope, in recent years, it has become more common to perform the excision of the stump with a stapler lock.

When a thick pancreatic body is excised by a suturing device that is currently used clinically for the excision of pancreatic parenchyma, the pancreatic capsule and pancreatic parenchyma are damaged, and it is sometimes considered that the suturing of the pancreatic main duct is erroneous. Thus, the inventors reported that pancreatic fistulas of class B or C were significantly reduced compared to conventional staplers using a reinforced three-pin stapler (non-patent document 1: Yamashita et al, Anticancer Res.37: 1865-. Here, it is reported that the error is 30% in the case of using a normal stapler, and the error is 5% in the case of using a reinforced three-staple stapler.

In another aspect, a clamp for surgically ligating a blood vessel while preventing blood flow is presented. For example, a polymer surgical clip has been proposed which is composed of first and second curved leg members, wherein proximal ends of both leg members are joined by an elastic hinge device, and a distal end of the first leg member is formed as a flexible hook portion which is curved toward the second leg member, while a distal end of the second leg member is formed as a locking portion which is complementary to the hook portion (patent document 1: japanese patent application laid-open No. 1-146536). Here, the inner side surface for clamping the blood vessel of the first leg member and the inner side surface for clamping the blood vessel of the second leg member face each other, and the radius of curvature of the inner concave surface of the first leg member is substantially the same as the radius of curvature of the inner convex surface of the second leg member. Therefore, as shown in fig. 7E, the respective inner side surfaces for pinching blood vessels overlap each other from the proximal end to the distal end of the leg members.

Further, there has been proposed a polymer surgical clip provided with first and second curved leg members connected by an elastic hinge device, each leg member having a vessel-gripping inner surface, one vessel-gripping inner surface facing the other vessel-gripping inner surface, and each vessel-gripping inner surface having a plurality of protrusions (patent document 2: japanese patent application laid-open No. 3-178648). Here, the radius of curvature of the concave surface on the inside of the first curved leg member for clamping blood vessels is substantially the same as the radius of curvature of the convex surface on the inside of the second curved leg member for clamping blood vessels, and as shown in fig. 12E, the respective inner side surfaces for clamping blood vessels overlap each other from the proximal end (hinge device proximal portion) to the distal end of both the curved leg members.

There has also been proposed a surgical clip provided with an upper jaw member and a lower jaw member joined to each other at a hinge region for movement about the hinge region (patent document 3: japanese patent application laid-open No. 2014-534014). Here, the upper jaw member and the lower jaw member are each configured to include an inwardly convex partition in a part of the hinge region and sandwich a proximal portion of the tissue. In addition, the maxillary component generally has an outer surface that is convex and an inner surface that is S-shaped, and the mandibular component generally has an outer surface that is concave and an inner surface that is S-shaped to almost conform or fit the contour of the inner surface of the maxillary component. Therefore, as shown in fig. 4, the respective grasping inner surfaces overlap each other from the hinge region to the distal end of the jaw members.

In addition, a surgical ligating clip for preventing movement for ligating a blood vessel or a tissue structure has been proposed (patent document 4: Japanese patent application laid-open No. 2018-518271). Disclosed herein is a surgical clip for ligating a blood vessel or a tissue structure, the surgical clip including: a first leg member including a first inner surface and a plurality of first protrusions disposed on the first inner surface; a second foot member including a second inner surface and a plurality of second protrusions disposed on the second inner surface; and a hinge member that joins the first leg member and the second leg member, wherein at least one of the plurality of first protrusions and the plurality of second protrusions has a gable structure extending in a longitudinal direction of the first inner surface or the second inner surface. As shown in fig. 3A, the inner surfaces of the leg members overlap each other.

Further, as a clip for ligating a blood vessel, a polymer Hem-o-lok (registered trademark) is sold by Teleflex corporation, and here, is constituted by first and second curved leg members curved in the same direction, the proximal ends of both leg members are joined by an elastic hinge, the distal end of the first leg member becomes a flexible hook portion curved toward the second leg member, and the distal end of the second leg member becomes a locking portion complementary to the hook portion. Here, the inner side surface for clamping the blood vessel of the first leg member and the inner side surface for clamping the blood vessel of the second leg member face each other, and the radius of curvature of the inner concave surface of the first leg member is substantially the same as the radius of curvature of the inner convex surface of the second leg member. Therefore, the vessel-sandwiching inner surfaces are overlapped with each other from the proximal end to the distal end of the leg members (https:// www.teleflex.com/usa/en/product-areas/patent/restriction-solutions/cement-polymer-restriction /).

Further, a ligation clip has been proposed which is made of metal and includes an upper jaw, a lower jaw, and a hinge portion for connecting the upper jaw and the lower jaw (see U.S. Pat. No. 6699258). Here, disclosed is a clip provided with a stress relaxation device (stress relaxation means) which is configured from a metal upper jaw and a metal lower jaw, wherein the metal upper jaw is curved outward, the metal lower jaw is provided with a lock portion at a first distal end portion, and a hinge portion at a second distal end portion on the opposite side of the first distal end portion, wherein the lock portion is configured to engage with the distal end portion of the upper jaw when the curved portion of the upper jaw is extended. In this clip, as shown in fig. 3, when the blood vessel is occluded, the curved portion of the upper jaw extends in a straight line and is permanently deformed, and the distal end of the upper jaw engages with the locking portion of the lower jaw. That is, the engagement is achieved by permanently extending the bent portion made of metal.

As a clip for appendectomy, an AESCULAP (registered trademark) DS clip is sold by b.braun AESCULAP corporation, where parallel occlusion is achieved by permanently extending the upper and lower jaws made of bent metal (https:// www.bbraun.jp/ja/products/b/DS-titanium-ligand).

Patent document 1: japanese laid-open patent publication No. 1-146536

Patent document 2: japanese laid-open patent publication No. 3-178648

Patent document 3: japanese Kokai publication Hei 2014-534014

Patent document 4: japanese Kokai publication Hei 2014-534014

Patent document 5: specification of U.S. Pat. No. 6699258

Non-patent document 1: yamashita et al, Anticancer res.37: 1865-1868, 2017

Disclosure of Invention

The present invention aims to provide an instrument and a method for fixing an excised organ stump, for example, a pancreas excised organ stump, generated during an operation of excising a part of an organ.

As a result of intensive studies to solve the above problems, the present inventors have found that a cut-off portion stump of a pancreas resulting from pancreatectomy can be easily fixed by using a polymer jig having a specific shape, and occurrence of a pancreatic fistula can be prevented or reduced, thereby completing the present invention. It is also understood that the present invention can be applied to other fragile organs than pancreas.

The present invention includes the following.

[1] A polymer-made surgical jig for organ resection (preferably for pancreas resection), comprising a first arm, a second arm, and an elastic hinge portion connecting the first arm and the second arm, wherein the first arm and the second arm are connected to the elastic hinge portion at their respective base portions, the first arm has a convex outer surface and a concave inner surface for holding an organ (preferably pancreas), the second arm has a convex or planar outer surface and a concave or planar inner surface for holding an organ (preferably pancreas), the inner surface of the first arm and the inner surface of the second arm are opposed to each other, a flexible hook portion is formed at the tip of the first arm so as to be bent toward the second arm, and the tip of the second arm enters the inside of the curved hook portion and engages with the hook portion at a closed position, the clamp is locked in a locked position, wherein,

the surgical clip is configured such that the first arm and the second arm maintain substantially the same shape in the open position and the closed position, and an inner surface of the first arm and an inner surface of the second arm which grip an organ (preferably a pancreas) are in the closed position, and a space is formed between both inner surfaces.

[2] The polymer surgical clip according to the above [1], wherein the second arm has a convex outer surface and a concave inner surface for grasping an organ (preferably pancreas), and the inner surface of the first arm and the inner surface of the second arm face each other to form opposite curved surfaces.

[3] The polymer surgical clip according to the above [1] or [2], wherein, in the closed position, a maximum distance generated between the inner surface of the first arm portion and the inner surface of the second arm portion is larger than any one of thicknesses between the inner surface and the outer surface of the first arm portion or the second arm portion.

[4] The polymer surgical clip according to any one of the above [1] to [3], wherein a thickness between the inner surface and the outer surface of the first arm portion is substantially the same as a thickness between the inner surface and the outer surface of the second arm portion.

[5] The polymer-made surgical jig according to any one of the above [2] to [4], wherein a radius of curvature of the concave inner surface of the first arm portion is substantially equal to a radius of curvature of the concave inner surface of the second arm portion.

[6] The polymer surgical clip according to any one of the above [1] to [5], wherein the first arm portion and the second arm portion each have one or two protrusions extending laterally.

[7] The polymer surgical clip according to any one of the above [1] to [6], further comprising a ridge portion on an inner surface near the base of the first arm portion and an inner surface near the base of the second arm portion.

[8] The polymer surgical clip according to any one of the above [1] to [7], wherein the inner surface of the first arm portion and/or the inner surface of the second arm portion is a surface having an uneven surface or a surface having a plurality of protrusions.

[9] The polymer-made surgical clip according to any one of the above [1] to [8], wherein the shape of the entire clip at the closed position is memorized.

[10] The polymer surgical clip according to any one of the above [1] to [9], which is made of a bioabsorbable polymer.

[11] The polymer-made surgical jig according to any one of the above [1] to [10], which is used for fixing a cut-off portion stump of an organ (preferably a pancreas) cut off by an organ cutting operation (preferably a pancreatectomy).

[12] The polymer-made surgical clip according to [11] above, which is configured to hold the pancreas at a pressure of at least 4kPa or more, more preferably 5kPa or more, and still more preferably 6kPa or more, when fixing the incised part and the remaining end of the pancreas.

[13] The polymer-made surgical jig according to any one of the above [1] to [12], which is used in a surgical method selected from the group consisting of pancreatectomy, pancreaticoduodenectomy, pancreatic tumor nucleation, and pancreaticotomy.

[14] A method of cutting a part of an organ (preferably pancreas) (preferably a tail part or a head part of the pancreas), wherein the vicinity of the cut part of the organ (preferably pancreas) is fixed by the polymer-made surgical jig according to any one of the above [1] to [12 ].

[15] A method of a surgical operation such as a pancreatectomy or a pancreaticoduodenectomy, wherein the vicinity of the cut part of the pancreas is fixed by the polymer surgical jig according to any one of the above [1] to [13 ].

According to the present invention, there are provided a jig for fixing a stump of an organ resection portion (preferably, pancreas resection portion), and a method for fixing a stump of an organ resection portion (preferably, pancreas resection portion stump) using the jig.

Drawings

FIG. 1 is a side view of one embodiment of a surgical clip of the present invention.

Fig. 2 is a perspective view of the embodiment of fig. 1.

Fig. 3 (a) is a side view of the state where the clamp of the embodiment of fig. 1 is opened, and fig. 3 (B) is a side view of the state where the clamp is closed.

FIG. 4 is a perspective view showing a state in which the surgical clip of FIG. 1 is attached to the stump of a pancreas dissection portion.

FIG. 5 is a side view of one embodiment of a clip of the present invention having a protrusion.

Fig. 6 is a perspective view of the embodiment of fig. 5.

Fig. 7 (a) is a side view of another embodiment of the surgical clip of the present invention. Fig. 7 (B) is a side view of the locked position of the clamp.

Fig. 8 (a) is a side view of another embodiment of the surgical clip of the present invention. Fig. 8 (B) is a side view of the locked position of the clamp.

Fig. 9 (a) is an embodiment of the clip in which the shape is memorized in a state where the first arm portion and the second arm portion are slightly opened. Fig. 9 (B) is an embodiment of the clip in which the shape memory is performed in a state where the first arm portion and the second arm portion are largely opened. Fig. 9 (C) shows an embodiment of the clip in which the first arm portion and the second arm portion are locked to each other and the shape of the clip is memorized.

Fig. 10 (a) is a side view of a state in which a jig having a shape memory in a slightly opened state between a first arm and a second arm is set in a setting device. Fig. 10 (B) is a side view of the opened state of the clamp.

Fig. 11 is a side view of a state in which a jig, which is shape-memorized in a state in which the space between the first arm and the second arm is largely opened, is set in the setting device.

Fig. 12 is a side view of a state in which the jig, which is shape-memorized in a state in which the first arm portion and the second arm portion are locked, is set to the setting device. However, in order to facilitate the operation of opening the jig, the jig is set in the setting device after the engagement between the first arm distal end portion and the second arm distal end portion is released.

Fig. 13 is a side view of an example of a setting device (closer) for setting the clamp to the closed state (locking the first arm distal end portion and the second arm distal end portion) after the pancreas is held by the shape-memorized clamp in the state where the first arm portion and the second arm portion are closed.

Detailed Description

The present invention will be described below, by way of examples of embodiments, together with preferred methods and materials that can be used in the practice of the invention. In addition, unless otherwise defined herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In addition, any material and method that are the same or similar to those described in the present specification can be used in the practice of the present invention. In addition, all publications and patents cited in the present specification in connection with the invention described in the present specification constitute a part of the present specification as contents showing methods, materials, and the like that can be used in the present invention, for example.

In the present specification, when expressions such as "X to Y" are used, X is included as a lower limit and Y is included as an upper limit, or X is included as an upper limit and Y is included as a lower limit. In the present specification, the term "about" means that the term "about" is used to the extent of ± 10% or less.

Hereinafter, the surgical clip of the present invention will be described in detail by way of example in which it is applied to the pancreas, but the surgical clip of the present invention can be applied to other organs, such as the liver, lung, appendix, and ovary, which are weak and thick as the pancreas, in addition to the pancreas. Therefore, the clip of the present invention is a clip for fixing the stump of a severed part of an organ selected from the group consisting of pancreas, liver, lung, appendix, and ovary, and preferably a clip for fixing the stump of a severed part of a pancreas.

The surgical clip of the present invention includes a first arm portion, a second arm portion, and an elastic hinge portion connecting the first arm portion and the second arm portion, and both the first arm portion and the second arm portion are connected at their base portions via the hinge portion. The first arm portion and the second arm portion are configured to engage at respective distal end portions (distal end portions) when the clamp is in the closed position. The hinge portion is elastic and can move the first arm portion and the second arm portion to the open position and from the open position to the closed position. Each arm portion has opposing inner side surfaces. The inner surface of the first arm portion is concave. The inner surface of the second arm portion is concave or planar, preferably concave. Thus, even at the locked position where the distal end portions of the first arm portion and the second arm portion are engaged, the inner side surfaces do not closely overlap with each other, and a space is secured between the inner side surfaces of the first arm portion and the second arm portion. Therefore, even when a fragile organ such as a pancreas is held, excessive damage to the organ can be prevented.

The first arm portion has a hook portion at its distal end, the hook portion being flexible (having a property of bending in a flexible manner) and bent toward the second arm portion. Since the hook portion is flexible, when the first arm portion and the second arm portion move from the open position toward the closed position about the hinge portion, the distal end portion of the second arm portion comes into contact with the hook portion, and when both the arm portions further move toward the closed position, the hook portion is flexed in the outer direction of the first arm portion, and the distal end portion of the second arm portion enters the inner side of the hook portion of the first arm portion. Thereby, the outer surface of the distal end portion of the second arm portion is engaged with the inner side of the hook portion of the first arm portion, and the clip is locked at the lock position.

The curved shape of the hook portion includes any form of a gentle curve and a steep curve, and also includes a form called buckling, but is preferably a curved state or a buckled state which is a steep curve. This allows a good engagement state (locked state) with the second arm portion to be formed, and a good locked state to be maintained. However, when it is desired to avoid an excessive load on the hook portion, or when it is desired to increase the space between the first and second arm portions, a gentle curve can be used.

The inner and outer surfaces of the hook portion can be continuously bent and closed, and thus, excessive stress concentration at the corner portion can be prevented.

The jig of the present invention may include one or two cylindrical protruding portions extending laterally at positions distant from the hinge portion in each of the first arm portion and the second arm portion, and preferably includes two protruding portions on both sides of the side surface. By providing the protrusion, when the jig is set in the setting tool, the jig can be stably held in the setting tool, and the opening and closing operation of the jig is facilitated by using the setting tool.

The surgical clip of the present invention can be used to fix the excised stump of the pancreas. However, the present invention is not limited thereto, and can be used in pancreatectomy, for example, pancreatectomy, pancreaticoduodenectomy, pancreaticoduodenal resection, tumor nuclectomy, and preferably pancreaticotomy. The surgical clip of the present invention can be used for fixing pancreatic parenchyma, but is preferably used for fixing pancreatic parenchyma on the side of the resected pancreatic body. The stump main pancreatic duct is preferably ligated and excised prior to fixation with a jig, but ligation may not be performed.

In addition, the surgical jig of the present invention is used together with the applier, thereby enabling fixation of the excised stump of the pancreas in a laparoscopic pancreatectomy.

Hereinafter, preferred embodiments of the surgical clip according to the present invention will be described with reference to the drawings. However, the present invention is not limited to the embodiment described below.

Fig. 1 shows one embodiment of a surgical clip according to the present invention. The clip of the present invention, which can be used to fix the stump of the excised portion of the pancreas, is composed of a first arm portion 1, a second arm portion 2, and a hinge portion 3 connecting the two arm portions at their respective base portions. The hinge portion 3 is elastic. Therefore, the first arm portion and the second arm portion can be opened from the position shown in fig. 1 to the position shown in fig. 3 (a), and can be moved to the closed position shown in fig. 3 (B). As a result, the pancreas is sandwiched between the first arm and the second arm in the open state shown in fig. 3 (a), and then the first arm and the second arm are moved to the closed state shown in fig. 3 (B), whereby the pancreas can be fixed. As a result, when the pancreas is cut, the remaining pancreas portion near the cut portion of the pancreas (the pancreas head side of the cut portion in the case of cutting the tail of the pancreas) can be fixed. The pancreas can be excised as follows: the method of cutting the remaining portion in the vicinity of the cutting portion of the pancreas after fixing the remaining portion with the jig of the present invention, and then cutting the cut portion, or the method of cutting the pancreas to separate the cut portion and then fixing the vicinity of the cutting portion, is preferable, but the cutting is performed after fixing with the jig. FIG. 4 is a view showing a state in which the excised stump of the pancreas was fixed.

The first arm portion 1 has a concave inner surface 11 and a corresponding convex outer surface 12, and the hook portion 4 is disposed on the distal end portion (distal end portion) side thereof. The second arm portion 2 has a concave or planar inner surface 13 and a convex or planar outer surface 14, and has a distal end portion 7 at a distal end thereof, which engages with the hook portion 4.

The hook 4 is bent toward the second arm and includes a bent portion 5 and a distal end portion 6. The hook portion 4 is flexible, and when the first arm portion and the second arm portion move from the open position to the closed position around the hinge portion, the hook portion 4 is flexed in the outer direction of the first leg member, and the distal end portion 7 of the second arm portion enters the inner side of the curved hook portion, and engages with the hook portion 4 to lock the clip at the closed position. In the locked state, the distal end portion 6 and the distal end portion 7 are engaged with each other, and the first arm portion and the second arm portion are fixed at the locked position.

In the clip of the present invention, the first arm portion and the second arm portion do not change in shape, and are the same or substantially the same, in any state, for example, an open state or a closed state. Therefore, in the closed state, the inner surface of the first arm portion maintains a concave shape, while the inner surface of the second arm portion maintains a concave or planar (preferably concave) shape, so that a space can be secured between the inner surfaces.

The shape of the inner side of the hook 4 and the shape of the distal end portion 7 of the second arm engage with each other in the closed state, and there is no particular limitation as long as the cut-off portion distal end of the pancreas can be fixed. The shape of the curved portion 5 of the hook 4 includes either a gentle curve or a steep curve, and further includes a form called buckling, but a steep curve or a buckling state is preferable. However, when it is desired to avoid an excessive load on the hook portion, or when the space between the first arm portion and the second arm portion is intended to be large, a gentle curve can be used. On the other hand, the shape of the distal end portion 7 of the second arm portion 2 is preferably a shape that easily enters the inside of the bent portion 5 in a bent or flexed state and that does not come off when engaged in a state in which the pancreas is fixed, and for example, a shape in which the thickness decreases as the distal end approaches can be cited. In order to prevent the hook portion 4 and the distal end portion 7 from coming off after the engagement, a claw, for example, may be provided in each of them. By adopting these shapes for the hook portion 4 and the distal end portion 7, the pancreas head side of the pancreas cutting portion can be easily fixed, and a good engagement (locked state) is formed between the both, and the locked state in which the pancreas is pinched can be well maintained.

In the preferred embodiment, the thickness between the inner surface 11 and the outer surface 12 of the substantial portion (i.e., the substantial portion excluding the distal end portion and the base portion) of the first arm portion is substantially constant over the entire length. In the preferred embodiment, the thickness between the inner side surface 13 and the outer side surface 14 of the substantial portion (i.e., the substantial portion excluding the tip portion and the base portion) of the second arm portion is substantially constant over the entire length. The thickness of the first arm portion and the thickness of the second arm portion are preferably substantially the same. The thickness of the first arm portion or the second arm portion is not particularly limited and may be appropriately selected depending on the material used, but is preferably 2mm to 10mm, more preferably 2mm to 7mm, and still more preferably 2mm to 6 mm.

The inner surface side 11 of the first arm portion is concave, but the radius of curvature of the concave inner surface can be appropriately selected according to the size and shape of the object to be fixed. The inner surface side 13 of the second arm portion is concave or planar, but is preferably concave. When the inner surface side of the second arm portion is a concave shape, the radius of curvature of the concave inner surface can be appropriately selected according to the size and shape of the object to be fixed. Since the inner surfaces 11 are concave, and the inner surfaces 13 are concave or planar, the inner surfaces do not overlap in parallel when the hook is closed, and a space 21 is secured between the inner surfaces, as shown in fig. 3 (B). This can prevent excessive damage to organs even when a fragile organ such as a pancreas is sandwiched therebetween. When the inner surface sides of the first arm portion and the second arm portion are both concave, the radii of curvature thereof are preferably the same or substantially the same. The distance of the space 21 between the inner sides of the locking positions is appropriately selected according to the size and shape of the object to be fixed. In fact, since the thickness of the pancreas cutting portion is 0.5cm to 4cm, and in many cases 1cm to 2cm, a distance of the space 21 to a degree that the entire pancreas cutting portion can be firmly locked to some extent but not excessively strongly locked is appropriately selected according to the thickness of the cutting portion to be the purpose. The lower limit of the maximum width between the inner side surfaces in the space 21 is preferably about 1mm, more preferably about 2mm, and still more preferably about 3mm, and the upper limit is preferably about 15mm, more preferably about 10mm, still more preferably about 8mm, and still more preferably about 5 mm. Since the thickness of the pancreas is usually 1cm to 2cm, the clip having the maximum width of the space 21 of about 3mm to about 5mm is most versatile.

The length of the jig of the present invention is not particularly limited, and can be appropriately selected according to the size and shape of the object to be fixed. The thickness is not limited to this, but is preferably 3cm to 15cm, more preferably 4cm to 12cm, and still more preferably 5cm to 10 cm.

The size of the hook 4 in the first arm of the clip of the present invention is not particularly limited, and the ratio (A: B) of the hook 4 to the other parts is preferably 1: 2 to 1: 10, more preferably 1: 3 to 1: 8, and still more preferably 1: 5 to 1: 7.

The clip of the present invention can be provided with an anti-slip mechanism on the inner surface of the first arm portion and/or the inner surface of the second arm portion in order to prevent the clip from being displaced and detached after the clip is fixed to the pancreas. The anti-slip mechanism is not particularly limited as long as it can prevent the jig from being displaced, and any mechanism can be used, and for example, it can be realized by providing a surface having irregularities on the inner surface or by providing a plurality of protrusions on the inner surface.

Fig. 5 and 6 show another embodiment of the jig of the present invention. The jig of the present invention can be provided with cylindrical protruding portions 31, 32 extending laterally on the first arm portion and the second arm portion, respectively, at positions distant from the hinge portion 3. The number of the projections may be one or two for each arm portion, but two are preferable. When two projections are provided for each arm portion, the projections are preferably provided in pairs on both sides of the arm portion. When one projection is provided for each arm, the projections are preferably provided in pairs on the same side of the arm. The length and size of the projection are not particularly limited as long as the projection can be engaged with the locking mechanism of the setting tool.

The clip of the present invention can also be manufactured using shape memory plastic materials. The shape memorized in the above case is not particularly limited. For example, a shape-memory jig in a state where the first arm portion and the second arm portion are slightly opened as shown in fig. 9 (a), a shape-memory jig in a state where the first arm portion and the second arm portion are largely opened as shown in fig. 9 (B), or a shape-memory jig in a state where the first arm portion and the second arm portion are closed as shown in fig. 9 (C) may be used. If a shape-memorized clamp in an open state as in fig. 9 (B) is used, the pancreas can be easily held, while if a shape-memorized clamp in a closed state as in fig. 9 (C) is used, the closed state can be maintained more stably.

At a temperature from room temperature to body temperature, preferably body temperature, a clip having shape memory properties at the closed position as shown in fig. 9 (C) is preferable because the fixing operation is easier and the closed state can be maintained more stably for a longer period after the fixing. The clip having shape memory at the closed position in body temperature can be used as follows, for example. First, in the state of expanding the clamp (opened state), the clamp is cooled to room temperature or lower, and preferably kept in cold, to prevent locking and fixing by body temperature (to prevent a change to a memorized shape). In this state, the clamp is attached to the pancreas, and the clamp is locked to move to the locked state. It is more preferable to keep the opened state of the clip in a container that follows the opened state of the clip, and cool the clip until or before use. The cooling can be carried out, for example, by placing the jig together with the container in which the jig is installed in a refrigerator, or on ice. In use, the jig is removed from the container for use. When the clip is attached to the pancreas, the clip is heated to the body temperature, and thus the clip is fixed in shape to the closed position, which is the memorized shape. To facilitate shape fixation, physiological saline warmed to body temperature can also be applied to the clip.

The clip of the present invention can also be used with a applier, which is particularly useful in the case of laparoscopic surgery. Although the use example using the setter will be described with reference to fig. 10 to 13, the shape and the use form of the setter are not limited to these.

Fig. 10 shows an example of using the jig in a state where the space between the first arm and the second arm is slightly opened as shown in fig. 9 (a). Fig. 10 (a) shows a state in which the jig 100 is mounted on the setter 400 in use. The setting device 400 can be provided in a state where the jig 100 is sandwiched between the leg portions 41 and 42. In order to be able to open the clamp, the holder preferably takes the shape of a scissors. The leg portions 41 and 42 are provided with locking mechanisms 43 and 44, respectively, on the inner sides thereof. The locking mechanisms 43 and 44 can engage with the protrusions 31 and 32 of the jig, respectively, to fix the jig. The number of the locking mechanisms provided to each leg portion of the holder is one or two, but preferably two. Preferably the catch means takes the form of a U-shaped formation open towards the distal end of the foot. Thus, when the jig is brought close to the pancreas in the abdominal cavity with the jig fixed, the jig can be prevented from falling off.

FIG. 10B is an enlarged view showing a state in which the protrusion 32 of the jig is engaged with the locking mechanism 44 of the setting tool when the jig is set in the setting tool.

After the clip is set in the setting tool, the scissors-shaped setting tool is opened, and the clip can be operated to a further opened state. In the state where the clip is further opened, the clip is returned to the original state, and therefore, a force in the opposite direction acts on the locking mechanism of the setting tool and the protrusion of the clip, and therefore, when the opened clip is brought close to the pancreas, the clip can be prevented from falling off from the setting tool. After the opened clamp is arranged on the head side of the cutting part of the pancreas, the placing device is locked to lock the clamp in a locked state.

Fig. 11 shows an example in which the jig shown in fig. 9 (B) is used in a state in which the space between the first arm and the second arm is largely opened, that is, in an opened state. Fig. 11 shows a state in which the jig 100 is mounted to the setter 400 in use. The setting device 400 can be provided in a state where the jig 100 is sandwiched between the leg portions 41 and 42. The locking means 43, 44 of the holder preferably have a U-shaped configuration which is open towards the inside. Since the clip is returned to its original shape when the retainer is closed, the clip is prevented from falling off when the clip is moved toward the pancreas in the abdominal cavity because a force in the opposite direction acts on the locking mechanism of the retainer and the protrusion of the clip. After the opened clamp is arranged on the head side of the cutting part of the pancreas, the placing device is locked to lock the clamp in a locked state.

Fig. 12 is an example of using the jig in a state where the first arm portion and the second arm portion are locked as shown in fig. 9 (C). Fig. 12 shows a state in which the jig is set in the setting tool after the engagement between the first arm distal end portion and the second arm distal end portion is released in order to facilitate the operation of opening the jig. The setting device 400 can be provided in a state where the jig 100 is sandwiched between the leg portions 41 and 42. The locking means 43, 44 of the holder preferably have a U-shaped configuration which is open towards the outside. When the setter is opened, the jig is returned to its original shape, and therefore, a force in the opposite direction acts on the locking mechanism of the setter and the protrusion of the jig, and the jig can be prevented from falling off when the jig is moved toward the pancreas in the abdominal cavity. After the open clamp is placed on the head side of the pancreas at the cutting site of the pancreas, the holder is closed. The locking of the clamp in the locked state can be performed using a setter as shown in fig. 12, but if the locking is insufficient, the setter is detached from the clamp, and then the clamp can be locked using a closer as shown in fig. 13. The closer includes support portions 53 and 54 that come into contact with the protrusion of the clip.

Another embodiment using a jig in which the shape is memorized in a state where the first arm portion and the second arm portion are closed as shown in fig. 9 (C) is described below. For example, an example is shown in which a clip having a shape memorized at a closed position as shown in fig. 9 (C) is used, the clip having a temperature of about 30 to about 38 ℃, preferably about 37 ℃ which is a body temperature. In the closed state, the clamp cannot be brought close to the pancreas in the abdominal cavity, and therefore the clamp needs to be opened widely. First, the jig is cooled to room temperature or lower, preferably to about 4 ℃ or lower, in a widely spread state. The cooling to about 4 ℃ or lower can be performed by, for example, ice-cooling in a state where the jig is expanded. Alternatively, the opened clamp is placed in a container that resembles the opened clamp, and the clamp is refrigerated or cooled together with the container until or before use. This prevents the clip from changing to the closed state (to the shape stored) due to being heated to the body temperature, and thus the clip can be maintained in a wide open state. The conditions for preventing such a change in the stored shape can be appropriately selected depending on the material of the jig and the like. Next, a wide-opening jig is attached to the placement device, and is placed close to the pancreas on the head side of the pancreas at the cutting site of the pancreas. If necessary, the setter may be cooled in advance, and a cooling mechanism may be provided in the setter so that the temperature of the jig does not rise. The clamp provided to the pancreas is warmed to body temperature and thus tries to return to the memorized shape. Therefore, the operation of locking the clip in the locked state using the setter becomes easier. In addition, if necessary, a physiological saline solution heated to a body temperature may be applied to the clip in order to facilitate the clip to return to its original shape.

Fig. 7 shows another embodiment of the jig of the present invention. Here, the hinge portion 3 has a larger radius of curvature and a bulge-like structure 8 toward the inside direction in the vicinity of the base portion of each arm portion. The hinge portion 3 has a larger radius of curvature, so that the opening between the first arm portion and the second arm portion becomes larger, thereby bringing about an effect that the pancreas can be pinched more easily or thicker pancreas can be pinched. In addition, as shown in fig. 7 (B), in the closed state, the two bulge-like structures 8 are in contact with each other, so that the entire inside surface of the arm portion of the clip from the hinge portion to the distal end portion can apply the same force to the pancreas, and the fixation of the pancreas becomes sufficient.

Fig. 8 shows another embodiment of the jig of the present invention. Here, the hinge portion 3 is a larger radius of curvature and has a bulge-like configuration 8 toward the inside direction in the vicinity of the base portion of each arm portion, and the curved portion 5 of the first arm portion is a more gentle curve and has two bulge configurations 9 at the tip end portion of the first arm portion. Since the curved portion 5 has a more gentle curve, not only the molding but also the opening and closing operation of the jig are facilitated. Further, the opening between the first arm portion and the second arm portion is increased, and the space 21 between the inner side surfaces can be designed to be larger, and therefore, the fixing of the pancreas portion having a large thickness is suitable.

When the cut-off portion stump of the pancreas is fixed by the jig of the present invention, the main pancreatic duct of the pancreas lock portion is closed, and the auxiliary pancreatic duct is further closed as necessary, so that leakage of pancreatic juice from the pancreas stump (pancreatic fistula) can be prevented. In order to prevent leakage of pancreatic juice, the main pancreatic duct needs to be closed with a jig so that the pressure resistance of the main pancreatic duct is not less than a certain level. The pressure resistance of the main pancreatic duct required for preventing leakage of pancreatic juice and pancreatic fistula is desirably at least about 4kPa or more, preferably about 5kPa or more, and more preferably about 6kPa or more. Therefore, the clamp of the present invention fixes the cut-off portion stub of the pancreas to such an extent that a desired pressure resistance of the main pancreatic duct can be achieved, thereby preventing a pancreatic fistula. Therefore, it is desirable that the clamp of the present invention is configured to clamp the pancreas at a pressure of at least about 4kPa or more, preferably about 5kPa or more, and more preferably about 6kPa or more when fixing the incised part stump of the pancreas, and on the other hand, it is desirable that the upper limit is configured to clamp the pancreas at a pressure of such an extent that the occluded part of the pancreas clamped by the clamp of the present invention does not cause necrosis.

The clip of the present invention is preferably manufactured as an integrally molded plastic product. The plastic material is not particularly limited as long as it is a material having biocompatibility, but is preferably a commercially available biocompatible plastic or biodegradable plastic having a relatively high strength. Examples of preferred plastics are used in surgical implant surgery. Can be arbitrarily selected from these plastic materials according to the purpose. Examples of the biocompatible material include, but are not limited to, polyethylene, teflon (registered trademark), polyoxymethylene, polyurethane, polydioxanone, poly-e-caprolactone, polyvinyl chloride, polypropylene, polymethyl methacrylate, polystyrene, and derivatives thereof, and examples of the biodegradable or bioabsorbable material include polyglycolic acid, polylactic acid, copolymers thereof, polydioxanone, poly-e-caprolactone, and derivatives thereof. In addition, a plurality of the above-mentioned arbitrary materials may be blended at an arbitrary ratio to give a material.

When the jig of the present invention has shape memory, the plastic material having shape memory or a derivative thereof can be used, or a plurality of arbitrary materials can be mixed at an arbitrary ratio and used.

The surgical jig of the present invention can be manufactured by a known resin molding method, for example, injection molding or extrusion molding.

As described above, the present invention has been described by taking the excision of a pancreas as an example, but the surgical jig of the present invention can be used for a liver, a lung, an appendix, and an ovary which are weak and thick organs as in the pancreas. The jig of the present invention used for resection of the liver, lung, appendix, and ovary can be appropriately selected depending on the type of target organ, the size and state of the resected part, and other conditions, with respect to the distance between the inner surfaces of the two arm portions, the length and thickness of the arm portion, the ratio of the hook portion to the arm portion, and other configurations.

Examples

The surgical plastic of the present invention was produced as follows.

The mold for the jig was made of silicone rubber. Polycaprolactone having a molecular weight of about 8 ten thousand and having an excellent elastic modulus was melted by heating and filled in the mold. The jig having the desired shape was produced by natural heat release cooling.

Using the jig prepared above, a porcine pancreatectomy was performed. The abdomen of the pig (pancreas caudal resection model, 2 cases) was opened, and the body of the pancreas was visually attached with a jig. Then, the caudal side was cut away with surgical scissors. One month after surgery, the pigs were sham-killed to confirm a pancreatic fistula, and no pancreatic fistula was confirmed in the abdominal cavity. In addition, the pancreas portion fixed by the jig of the present invention is maintained in a good state.

Industrial applicability of the invention

The surgical clip of the present invention can be used to secure the excised stump of the pancreas.

Description of the reference numerals

A first arm; 2 … second arm; 3 … hinge portion; 4 … hook part; 5 … bend; 6 … first arm tip portion; 7 … second arm tip portion; 8. 9 … bulge-like configuration; 11 … inner side surface of first arm part; 12 … outside surface of the first arm; 13 … second arm medial surface; a second arm outboard side; 21 … space between the inner sides; 31. a 32 … protrusion; 41. 42 … setter foot; 43. 44 … latching mechanism; 51. 52 … closure foot; 53. 54 … a support portion; 100 … clamp; 400 … placing device; 500 … closer.