JPH11104140A - Medical ligation tool - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical ligation tool which ensures the tensile break strength of a line required for tightly fastening a lesion tissue region without increasing the diameter of the line in a ligation loop part. SOLUTION: This medical ligation tool comprises a flexible line 21 which forms a joinless and endless loop-like part 24 for ligation and a stopper 23 into which the line 21 is forced. In addition, the tool is operated by moving the stopper 23 to the tip side of the loop-like part 24 for ligation to squeeze the loop-like part 24 and thereby ligate a body tissue. The tensile break strength of the synthetic resin line 21 which forms the loop-like part 24 for ligation is increased by orientating the main orientation axis of the constituent molecule of the line 21 in its axial direction.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical ligature for binding a diseased tissue site in a body.

[0002]

2. Description of the Related Art This type of medical ligature is endoscopic,
That is, it is introduced into the body through a treatment instrument insertion channel of the endoscope, and a loop portion ligates a diseased tissue in the body. An example of this medical ligature is disclosed in Japanese Utility Model Laid-Open Publication No. 6-17712. In this medical ligating device, the wire material of the ligating loop portion is made of synthetic resin and elastic and flexible, and the ligated loop wire is used to bind the diseased tissue portion, and the ligated state remains for several days. Place a ligature in the body. Then, since the blood flow in the diseased tissue is stopped by the binding, the tissue is necrotic and the diseased part falls out several days later. At this time, the medical ligature also falls off at the same time and is naturally discharged from the anus.

[0003]

[Problems to be solved by the invention]

(Problems of the prior art) As a manufacturing method for forming a ligating loop portion of a medical ligating device described in Japanese Utility Model Application Laid-Open No. 6-17712, a method of forming at once a wire having a predetermined loop shape by injection molding. Forming a predetermined loop shape wire from a thin sheet-shaped synthetic resin material by punching it into a predetermined loop-shaped wire or pressing a thin wire made of thin synthetic resin into a circular wire into a predetermined loop shape by thermoforming Was to do.

[0004] In the loop wire produced by these molding or manufacturing methods, the orientation of molecules constituting the wire becomes random, and thus the tensile strength of the wire in the axial direction is low. In addition, since the medical ligature is used through the treatment tool insertion channel of the endoscope, the thickness of the loop wire is restricted, and it must be formed relatively thin. Therefore, in such a conventional loop wire of a medical ligature, the wire has a relatively low tensile breaking strength in the axial direction.

[0005] Therefore, when the ligated loop portion formed of such a loop wire is used to bind the diseased tissue and stop the blood flow of the tissue, the loop wire is sometimes easily broken. For this reason, it was very difficult to adjust the lesion tissue site with the necessary force.

Further, if the wire forming the ligating loop is made thicker in order to increase the tensile breaking strength, a new inconvenience arises such that the treatment instrument insertion channel of the endoscope cannot be passed through. For this reason, the wire forming the ligating loop cannot be made thicker.

(Object of the Invention) The present invention has been made in view of the above-mentioned problems. It is an object of the present invention to increase the tensile strength at break without increasing the thickness of a wire of a ligating loop. An object of the present invention is to provide a medical ligature capable of securing a required tensile breaking strength of a wire for binding a diseased tissue site while having a wire diameter that can be inserted into a treatment tool insertion channel of an endoscope.

[0008]

SUMMARY OF THE INVENTION The present invention has a flexible wire forming a ligating loop portion and a stopper press-fitted with the wire, and moves the stopper toward the distal end of the loop portion. In the medical ligature in which the loop portion is tightened by moving to ligate a tissue, the synthetic resin wire forming the ligating loop portion is formed into a seamless and endless loop shape, and the wire material is The main orientation axes of the constituent molecules are oriented substantially in the axial direction of the wire.

According to the medical ligating device of the present invention, the main orientation axis of the polymer of the wire constituting the wire of the ligating loop portion is set to an orientation substantially coincident with the axial direction of the wire. The crystallization of the molecule proceeds, and functional properties such as tensile rupture strength and other physical properties are improved. For this reason,
For example, even when formed with a relatively small wire diameter through which the forceps channel of the endoscope can be inserted, the wire material of the ligating loop portion is not broken when the diseased tissue site is tightened, and the diseased tissue site is efficiently tightened. Thus, the blood flow at the site of the diseased tissue can be reliably stopped.

[0010]

BEST MODE FOR CARRYING OUT THE INVENTION

[First Embodiment] A first embodiment of the present invention will be described with reference to FIGS. FIG. 1 is a cross-sectional view of a distal end portion of the ligating device, FIG. 2 is an explanatory diagram of a configuration of a medical ligating device used in the ligating device, and FIG. 3 is an explanatory diagram of a method of manufacturing a loop wire of the medical ligating device.

(Configuration) As shown in FIG. 1, the ligating apparatus 1 includes an insertion portion 11 and a hand-side operation portion (not shown).
The main body of the insertion portion 11 is constituted by a sheath 13, and an operation wire 14 is inserted into an inner hole of the sheath 13 so as to be able to advance and retreat. A hook 15 for detachably locking the ligature 2 is attached to a distal end of the operation wire 14. The hook 15 has an outer diameter that can be pulled into the sheath 13, and a hook 16 is formed at the tip of the hook 15. When the hook 16 is pulled into the sheath 13, the opening portion is closed by the inner surface of the sheath 13.

Next, the structure of the ligature 2 will be described. The ligature 2 includes an elastic flexible wire 21 formed in an endless loop shape without a seam, and a cylindrical stopper 23 pressed into one end of the bundle of the flexible wires 21. The stopper 23 frictionally engages with the flexible wire 21. The portion of the flexible wire 21 located on the distal side from the stopper 23 forms the ligating loop portion 24, while the portion of the flexible wire 21 located on the proximal end side of the stopper 23 from the stopper 23 is used for hook attachment. A loop portion 25 is formed.

The material of the flexible wire 21 is, for example, a synthetic resin material, for example, polyamide or polyolefin. Then, the flexible wire 21 is formed by the procedure shown in FIG. That is, first, a synthetic resin is injection-molded as shown in FIG. 3A to form a base member 26 having a wire diameter of 1.0 mm and a loop diameter of 15 mm. Then, as shown in FIG. 3 (b), the loop-shaped base member 26 is stretched at a stretching ratio of about 4 times to form a seamless endless loop having a wire diameter of 0.45 mm and a loop diameter of 54 mm. Flexible wire 2
1 and completed. The main axis of the constituent molecules of the flexible wire 21 is substantially oriented in the axial direction of the flexible wire 21 by the stretching process.

FIG. 6 is a perspective view showing a ligature shape holder for holding the ligature 2 when the ligature 2 is sterilized. The ligature shape retainer 31 is made of a material having heat resistance that is unlikely to cause thermal deformation or deterioration, and a flexible material such as a hydrogenated styrene-butylene-styrene-based elastomer resin so that the loop can be easily removed. A substantially plate-shaped main body 32 and an arrangement shape corresponding to the shape of the ligating loop portion 24 of the ligating device 2 formed on the main body 32, and the ligating loop portion 24 of the ligating device 2 can be fitted. A possible loop groove 33, a plurality of fixing claws 34 formed on the opening edge of the loop groove 33 to prevent deformation and detachment of the ligating loop portion 24, and a stopper 2 of the ligating device 2.
3 and a stopper groove 35 in which the stopper 23 is fitted and which can fix the stopper 23, and a hook mounting loop portion 25 formed at the base end of the main body 32.
And a notch 36 projecting therefrom. The claw 34 has a slit 37 so that the ligating loop 24 of the ligating tool 2 can be easily attached and detached.

(Operation) The operation when the medical ligature 2 is used using the ligating apparatus 1 will be described. The ligation device 1 is loaded with a medical ligature 2 at its distal end, and guides the ligature 2 into the body to perform a ligation operation to bind a diseased tissue site in the body.

First, as shown in FIG. 1, in a state where the hook 15 is hooked on the hook attaching loop portion 25 of the ligating device 2,
The hook 15 is pulled into the sheath 13. Then, the hook mounting loop portion 25 of the ligating device 2 is also drawn into the sheath 13. In this state, the insertion portion 11 of the ligation device 1 is introduced into the body through a treatment instrument insertion channel of an endoscope, for example.

The ligating loop 24 of the ligating device 2
Is hooked on the raised diseased tissue portion, and the hook 15 is retracted by operating a hand operation unit (not shown). Then, the flexible wire 21 of the ligature 2 connected to the hook 15 is pulled into the sheath 13, but the rear end of the stopper 23 abuts against the tip of the sheath 13. Only 21 is retracted into the sheath 13, and the ligating loop 24 on the distal end side of the ligating tool 2 is contracted to ligate the diseased tissue. This ligation stops blood flow to the diseased tissue.

Thereafter, when the operating wire 14 is pushed forward until the hook 15 protrudes outward from the distal end of the sheath 13, the hook 16 of the hook 15 is opened, the hook mounting loop 25 is released from the hook 16, and the ligation is performed. Only the tool 2 is moored at the ligated lesion tissue portion and is left in the body. The above operation completes the binding of the diseased tissue in the body.

Then, since the blood flow in the diseased tissue is stopped by the binding, the tissue is necrotized and the diseased part falls out several days later. At this time, the medical ligature also falls off at the same time and is naturally discharged from the anus.

Generally, this kind of medical ligature 2 is subjected to a sterilization process before use, for example, a sterilization process involving heating of an autoclave or the like. At that time, the ligating loop portion 24 of the ligating device 2 is fitted and mounted in the loop groove 33 of the ligating device holder 31, and the hook mounting loop portion 25 is cut out of the notch portion 36
And the stopper 23 is fitted into the stopper groove 35. If sterilization is performed in this state, the flexible wire 21 and the stopper 2 forming the ligating loop portion 24 and the hook attaching loop portion 25 are affected by the heat at that time.
3 can be prevented from being deformed into a shape that does not satisfy the function. This is effective for maintaining a loop shape of the ligating device 2 that is particularly desired to avoid deformation.

(Effect) Since the flexible wire 21 forming the ligating loop portion 24 of the medical ligature 2 has been subjected to stretching, the main orientation axis of the constituent molecules is substantially aligned with the axial direction of the wire. I do. Therefore, the tensile strength of the flexible wire 21 in the axial direction is improved. Here, as described above, the flexible wire 21 that has been subjected to the stretching treatment at the stretching ratio of about 4 times is used.
The tensile breaking strength in the axial direction of each of the unstretched flexible wire and the unstretched flexible wire was measured by a tensile tester, and as a result, the tensile strength of the stretched flexible wire 21 was 10%.
kgf (per wire), and the tensile breaking strength of the unstretched flexible wire was 3 kgf (per wire). From this result, the flexible wire 21 subjected to the stretching treatment
It can be seen that No. has a clearly higher tensile strength in the axial direction.

Therefore, even when the hook 15 is pulled with a strong force during the binding and the ligating loop portion 24 is contracted, the ligating loop portion 24 and the hook attaching loop portion 25 are hardly broken.
The diseased tissue can be sufficiently tied, and blood flow to the tissue can be stopped. In addition, the flexible wire 21 can be easily inserted into, for example, a treatment tool insertion channel of an endoscope or another introduction auxiliary tool without increasing the diameter of the wire in order to increase the tensile breaking strength. The effect of binding and necrosis of the tissue can be enhanced.

[Modification of First Embodiment] The loop diameter of the flexible wire 21 described in the first embodiment is not limited to this, and may be freely selected within a range of, for example, about φ24 to 80 mm. Is what you can do. Also,
The diameter of the wire is not limited thereto, and can be freely selected, for example, in a range of about φ0.2 to 0.6 mm.

As shown in FIG. 1, the shape of the ligating loop may be a perfect circle as shown in FIG. 4 or a polygon such as a hexagon as shown in FIG. Any shape may be used as long as the shape is possible.
Further, the material of the flexible wire 21 is not limited to the material described in the first embodiment, and even if the material is a synthetic resin such as polyester, polyethylene, and fluororesin, the main orientation axis of the constituent molecule is the same as that of the wire. Other materials may be used as long as they can be oriented in the axial direction.

From the above description, at least the following items and any combination of the items can be obtained. <Appendix> 1. A flexible wire that forms a ligating loop portion, and a stopper into which the wire material is press-fitted. By moving the stopper toward the distal end of the loop portion, the loop portion is tightened to ligate tissue. In the medical ligating device described above, the synthetic resin wire forming the ligating loop portion is formed into an endless loop shape without a seam, and the main orientation axis of the constituent molecules thereof substantially coincides with the axial direction of the wire. A medical ligature, characterized in that:

2. 2. The medical ligation device according to claim 1, wherein the flexible wire forming the ligating loop has a main orientation axis of constituent molecules substantially oriented in the axial direction of the wire by stretching. Ligature.

3. 2. The medical ligating device according to claim 1, wherein the material of the flexible wire forming the ligating loop portion is a synthetic resin containing polyamide as a main component.

4. 2. The medical ligature according to claim 1, wherein the material of the flexible wire forming the ligating loop is made of a synthetic resin containing polyolefin as a main component. 5. 2. The medical ligature according to claim 1, wherein the material of the flexible wire forming the ligating loop portion is a synthetic resin containing polyethylene terephthalate as a main component.

6. 2. The medical ligating device according to claim 1, wherein the material of the flexible wire forming the ligating loop portion is a synthetic resin containing fluorine as a main component.

[0030]

As described above, in the medical ligating device of the present invention, the synthetic resin wire forming the seamless and endless loop-shaped ligating loop has a main orientation axis of constituent molecules whose axis is the axis of the wire. By almost conforming to the direction, the other physical properties such as the tensile breaking strength of the wire were improved. Therefore, even when the binding force is strong, the wire forming the ligating loop or hook attachment loop is not broken, and the diseased tissue can be bound and the blood flow of the tissue can be stopped. Quality can be obtained.

[Brief description of the drawings]

FIG. 1 is a cross-sectional view of a distal end portion of a ligating device loaded with a medical ligating device according to a first embodiment.

FIG. 2 is an explanatory view of the medical ligature according to the first embodiment.

FIG. 3 is an explanatory view of a method for manufacturing a loop wire of the medical ligature according to the first embodiment.

FIG. 4 is an explanatory view of a medical ligature according to a modification of the first embodiment.

FIG. 5 is an explanatory view of a method for manufacturing a loop wire of the medical ligature according to the first embodiment.

FIG. 6 is a perspective view of a ligature holder for holding the ligature when sterilizing the medical ligature according to the present invention.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Ligation device, 2 ... Ligation tool for medical use, 11 ... Insertion part, 13
... Sheath, 14 ... Operation wire, 15 ... Hook, 21 ... Flexible wire, 23 ... Stopper, 24 ... Ligation loop part, 2
5 ... Hook attachment loop part.

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[Procedure amendment]

[Submission date] November 18, 1997

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] 0011

[Correction method] Change

[Correction contents]

(Configuration) As shown in FIG. 1, the ligating apparatus 1 includes an insertion portion 11 and a hand-side operation portion (not shown).
The main body of the insertion portion 11 is constituted by a sheath 13, and an operation wire 14 is inserted into an inner hole of the sheath 13 so as to be able to advance and retreat. A hook 15 for detachably locking the ligature 2 is attached to a distal end of the operation wire 14. The hook 15 have a freely outside diameter drawn into the sheath 13, the distal end portion of its hanging hole 16 is formed. When the hook 16 is pulled into the sheath 13, the opening portion is closed by the inner surface of the sheath 13.

[Procedure amendment 2]

[Document name to be amended] Statement

[Correction target item name] 0020

[Correction method] Change

[Correction contents]

Generally, this kind of medical ligature 2 is subjected to a sterilization process before use, for example, a sterilization process involving heating of an autoclave or the like. At that time, the ligating loop portion 24 of the ligating device 2 is fitted and mounted in the loop groove 33 of the ligating device shape holding device 31, and the hook mounting loop portion 25 is located in the notch portion 36 and the stopper groove 35. , Stopper 2
3 is inserted. And if sterilization is performed in this state,
It is possible to prevent the flexible wire 21 and the stopper 23 constituting the ligating loop portion 24 and the hook attaching loop portion 25 from being deformed into a shape not satisfying the function due to the influence of heat at that time. This is effective for maintaining a loop shape of the ligating device 2 that is particularly desired to avoid deformation.

[Procedure amendment 3]

[Document name to be amended] Statement

[Correction target item name] Fig. 5

[Correction method] Change

[Correction contents]

FIG. 5 is an explanatory view of a medical ligature according to a modification of the first embodiment.

[Procedure amendment 4]

[Document name to be amended] Statement

[Correction target item name] Fig. 6

[Correction method] Change

[Correction contents]

FIG. 6 is a perspective view of a ligature shape holder that holds the ligature when sterilizing the medical ligature according to the present invention.

Claims (1)

[Claims] The present invention has a flexible wire forming a ligating loop and a stopper press-fitted with the wire, and the stopper is moved toward the distal end of the loop to tighten the loop. In a medical ligature adapted to ligate a tissue, the synthetic resin wire forming the ligating loop is formed into a seamless and endless loop shape, and the main orientation axis of the constituent molecules is in the axial direction of the wire. A medical ligating device characterized in that it has an orientation substantially matching with the above.