JP4050302B2 - Medical ligature and ligature shape holder - Google Patents

Description

  The present invention relates to a medical ligation tool and a ligation tool shape holder for binding a diseased tissue site in the body.

This type of medical ligation instrument is transendoscopically, that is, introduced into the body through a channel for insertion of a treatment instrument of an endoscope, and ligates a diseased tissue in the body at the loop portion. An example of this medical ligation tool is shown in Japanese Utility Model Laid-Open No. 6-17712. In this medical ligation apparatus, the wire material of the ligation loop portion is made of an elastic flexible material made of synthetic resin, and the lesion tissue portion is tightly bound by the ligation loop wire, and the ligation state is maintained for several days. Place ligatures in the body. Then, since the blood flow in the lesioned tissue part is stopped by the tight binding, the tissue part is necrotized after several days, and the lesioned part falls off. At this time, the medical ligation tool also falls off at the same time and is naturally discharged from the anus.
Japanese Utility Model Publication No. 6-17712

(Problems of conventional technology)
As a manufacturing method for forming the ligation loop portion of the medical ligation tool described in Japanese Utility Model Laid-Open No. 6-17712, a method of forming a predetermined loop-shaped wire at a time by injection molding, a thin sheet-like composition A material made by punching a predetermined loop-shaped wire from a resin material with a press die, or a circular wire formed by cutting a tube made of a thin synthetic resin into a predetermined loop shape by thermoforming.

  Moreover, in the loop wire made by these molding or manufacturing methods, the orientation of the molecules constituting the wire becomes random, so the tensile break strength in the axial direction of the wire is low. In addition, since the medical ligation tool is used through the treatment instrument insertion channel of the endoscope, the thickness dimension of the loop wire is limited, and it must be formed relatively thin. Therefore, in the loop wire of the conventional medical ligation tool, the tensile breaking strength in the axial direction of the wire is relatively weak.

  Therefore, when the lesioned tissue portion is tightly bound by the loop portion for ligation formed of such a loop wire and the blood flow of the tissue is stopped, sometimes the loop wire is easily broken. For this reason, it has been very difficult to control the lesion tissue site with the necessary force.

  Further, if the wire is thickened in order to increase the tensile breaking strength of the wire forming the ligation loop, a new inconvenience such as the inability to pass the treatment instrument insertion channel of the endoscope occurs. For this reason, the wire which forms the ligation loop portion cannot be made thicker than that.

  The present invention prevents deformation of a ligation loop portion of a ligation tool that easily deforms into a shape that does not satisfy a function due to the influence of heat when a flexible wire constituting the ligation loop portion is subjected to sterilization with heating. An object of the present invention is to provide a medical ligation tool and a ligation tool shape holder.

  The invention according to claim 1 is a medical ligation tool in which a ligation loop portion for ligating a tissue site in a body cavity is formed by a flexible synthetic resin wire material, the ligation tool including a holder body, and the holder body Further, the medical ligation tool is characterized in that the wire material of the ligation loop portion is arranged and held in a shape corresponding to the shape of the loop portion.

  The invention according to claim 2 uses a flexible synthetic resin wire formed in a loop shape as a base material, and makes the base material longer than the base material by applying a stretching process to the base material. A medical ligation tool in which a main ligation axis of constituent synthetic resin molecules is oriented in a direction substantially coinciding with the axial direction of the wire to form a ligation loop for ligating a tissue site in a body cavity, and holding A medical ligation tool comprising: a tool body, wherein the wire body of the ligation loop portion is disposed and held in the holder body in a shape corresponding to the shape of the loop portion.

According to a third aspect of the present invention, there is provided a loop groove in which the holder body is fitted with the wire material of the ligation loop portion, and the wire material of the ligation loop portion is arranged and held in a shape corresponding to the shape of the loop portion. The medical ligation tool according to claim 1 or 2, further comprising: a fixing claw for preventing the wire rod of the ligation loop portion fitted in the loop groove from coming off. The invention according to claim 4 is characterized in that the holder main body has flexibility that can be easily deformed when the ligating loop portion is removed. Or it is a medical ligation tool of Claim 3.

  According to a fifth aspect of the present invention, in the first, second, third, or fourth aspect, the synthetic resin wire is formed in an endless loop shape without a seam. The medical ligation tool described.

  The invention according to claim 6 is a ligature shape holder for holding a medical ligature formed with a ligation loop portion for ligating a tissue site in a body cavity with a flexible synthetic resin wire, A ligature shape holder having a main body, wherein the wire of the ligation loop portion is arranged and held in the holder main body in a shape corresponding to the shape of the loop portion.

  The invention according to claim 7 uses a flexible synthetic resin wire formed in a loop shape as a base material, and makes the base material longer than the base material by applying a stretching process to the base material. A ligature for holding a medical ligation tool having a ligation loop portion for ligating a tissue site in a body cavity with the main orientation axis of the constituent molecules of the synthetic resin constituting the material oriented in a direction substantially coinciding with the axial direction of the wire. A shape holder, having a holder main body, and holding and holding the wire material of the loop portion for ligation in a shape corresponding to the shape of the loop portion in the holder main body It is a holding tool.

  According to the present invention, the flexible wire constituting the ligation loop portion is easily deformed into a shape that does not satisfy the function due to the influence of heat when performing sterilization with heating. Deformation can be prevented.

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

(Constitution)
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 the inner hole of the sheath 13 advances and retreats. The operation wire 14 is inserted through as possible. A hook 15 for detachably locking the ligature tool 2 is attached to the tip of the operation wire 14. The hook 15 has an outer diameter that can be retracted into the sheath 13, and a hook 16 is formed at the tip. When the hook 16 is drawn into the sheath 13, the opening is closed by the inner surface of the sheath 13.

  Next, the configuration of the ligature tool 2 will be described. The ligature tool 2 includes an elastic flexible wire 21 formed in a seamless endless loop shape, and a cylindrical stopper 23 press-fitted into one end of the flexible wire 21 in a bundled state. The stopper 23 is frictionally engaged with the flexible wire 21. The ligating loop portion 24 is formed by the portion of the flexible wire 21 that is located on the distal end side of the stopper 23, while the portion of the flexible wire 21 that is located on the proximal side of 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, and for example, polyamide or polyolefin is used. And the flexible wire 21 is formed in the procedure shown in FIG. That is, first, as shown in FIG. 3A, synthetic resin is injection-molded to form a base member 26 having a wire diameter of 1.0 mm and a loop diameter of 15 mm. Next, as shown in FIG. 3 (b), the loop-shaped base member 26 is stretched at a stretch ratio of about 4 times to obtain a seamless endless loop-shaped loop with a wire diameter of 0.45 mm and a loop diameter of 54 mm. It forms in the flexible wire 21, and is completed. The flexible wire 21 is orientated so that the main orientation axis of the constituent molecules is substantially oriented in the axial direction of the flexible wire 21.

  On the other hand, FIG. 6 is a perspective view showing a ligation tool shape holder that holds the ligation tool 2 when the ligation tool 2 is sterilized. The ligature shape holder 31 is made of a heat-resistant material that hardly undergoes thermal deformation or deterioration and is flexible so that the loop can be easily removed, such as hydrogenated styrene-butylene-styrene elastomer resin. A substantially plate-like main body 32 and an arrangement shape corresponding to the shape of the ligation loop portion 24 of the ligation tool 2 formed on the main body 32, and the ligation loop portion 24 of the ligation tool 2 can be fitted. The loop groove 33 that can be formed, a plurality of fixing claws 34 that are formed at the opening edge of the loop groove 33 and prevent deformation and removal of the ligation loop portion 24, and the outer diameter of the stopper 23 of the ligature tool 2 are substantially the same. It has a stopper groove 35 in which the stopper 23 can be fitted and fixed, and a notch portion 36 formed at the base end portion of the main body 32 from which the hook mounting loop portion 25 protrudes. It has been made. The claw 34 has a slit 37 so that the ligation loop portion 24 of the ligation tool 2 can be easily attached and detached.

(Function)
The operation when the medical ligation tool 2 is used using the ligation apparatus 1 will be described. The ligation apparatus 1 is loaded with a medical ligation instrument 2 at its tip, and performs a ligation operation for guiding the ligation instrument 2 into the body and binding a lesion tissue site in the body.

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

  Then, the ligation loop portion 24 of the ligature tool 2 is hung on the raised lesioned tissue portion, and the hook 15 is retracted by operation of a hand operation portion (not shown). Then, the flexible wire 21 of the ligation tool 2 connected to the hook 15 is drawn into the sheath 13, but the rear end of the stopper 23 abuts against the distal end of the sheath 13, so the flexible wire of the ligation tool 2. Only 21 is drawn into the sheath 13, and the ligation loop 24 on the distal end side of the ligature tool 2 is contracted to ligate the lesioned tissue part. This ligation stops blood flow to the affected tissue.

  Thereafter, when the operation 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, and the hook mounting loop portion 25 is detached from the hook 16, and only the ligature tool 2. Is anchored to the lesioned tissue part that has been ligated and placed in the body. The above operation completes the binding of the diseased tissue in the body.

  Then, since blood flow in the lesioned tissue part is stopped by the tight binding, the tissue part is necrotized after several days, and the lesioned part falls off. At this time, the medical ligation tool also falls off at the same time and is naturally discharged from the anus.

  By the way, generally this kind of medical ligation tool 2 performs sterilization processing, for example, sterilization processing accompanied by heating, such as an autoclave, before use. At that time, the ligation loop portion 24 of the ligation tool 2 is fitted into the loop groove 33 of the ligation tool shape holder 31 and attached, and the hook attachment loop portion 25 is positioned at the notch portion 36 and the stopper groove 35. The stopper 23 is fitted. If sterilization is performed in this state, the flexible wire 21 and the stopper 23 constituting the ligation loop portion 24 and the hook attachment loop portion 25 are deformed into a shape that does not satisfy the function due to the influence of heat at that time. Can be prevented. This is effective in maintaining the loop shape of the ligature tool 2 that is particularly desired to avoid deformation.

(effect)
Since the flexible wire 21 forming the ligation loop portion 24 of the medical ligation tool 2 has been subjected to a stretching process, the main orientation axis of the constituent molecules thereof substantially matches the axial direction of the wire. For this reason, the tensile breaking strength of the axial direction of the flexible wire 21 is improved.

  Here, as described above, the tensile breaking strength in the axial direction of each of the stretched flexible wire 21 and the unstretched flexible wire 21 was measured with a tensile tester at a stretch ratio of about 4 times. As a result, the tensile breaking strength of the stretched flexible wire 21 is 10 kgf (per wire), and the unstretched flexible wire is 3 kgf (per wire). Met. From this result, it can be seen that the stretched flexible wire 21 has a clearly higher axial tensile strength.

  Therefore, even if the hook 15 is pulled with a strong force at the time of binding and the ligation loop portion 24 is contracted, the ligation loop portion 24 and the hook mounting loop portion 25 are not easily broken. The blood flow to the can be stopped. Further, in order to increase the tensile breaking strength of the flexible wire 21, for example, it can be easily inserted into a treatment instrument insertion channel of an endoscope or other introduction aids without increasing the diameter of the wire, and a lesion It is possible to enhance the effect of tying up the tissue part and causing necrosis.

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

  As shown in FIG. 1, the shape of the ligation loop portion may be a perfect circle as shown in FIG. 4 or a polygon such as a hexagon as shown in FIG. 5, and can be hooked on a lesion tissue portion. Any shape can be used as long as it is a simple shape. In addition, the material of the flexible wire 21 is not limited to that described in the first embodiment, and the main orientation axis of the constituent molecules of the synthetic resin such as polyester, polyethylene, and fluororesin is the wire. Other materials may be used as long as they can be oriented in the axial direction.

  According to this medical ligation tool, the main orientation axis of the polymer of the wire constituting the wire of the ligation loop portion is oriented so as to substantially coincide with the axial direction of the wire, thereby enabling the crystallization of the wire molecule. Advances and functionally improves other physical properties such as tensile strength at break. For this reason, for example, even when the diameter of the forceps channel of the endoscope is formed with a relatively thin wire diameter, when the lesion tissue site is tied, the wire material of the ligation loop portion is not broken, and the lesion tissue site is efficiently The blood flow at the lesioned tissue site can be reliably stopped.

  From the above description, at least the following items and arbitrary combinations of the items can be obtained.

<Appendix>
1. It has a flexible wire forming the loop portion for ligation and a stopper press-fitted with the wire, and the stopper is moved toward the distal end side of the loop portion so that the loop portion is tightened to ligate the tissue. In the medical ligation tool, the synthetic resin wire forming the ligation loop portion is formed into an endless loop shape with no seam, and the main orientation axis of the constituent molecules is substantially aligned with the axial direction of the wire. A medical ligature characterized by the above. Synthetic resin wire that forms a seamless ligating loop part with endless loops, the main orientation axis of the constituent molecules almost matches the axial direction of the wire, and other physical properties such as tensile strength at break of the wire Improved. Therefore, even when the binding force is strong, the wire forming the loop part for ligation and the hook attachment part does not break, and the lesioned tissue part can be tightly bound to stop the blood flow of the tissue, making it safer and more stable. Quality can be obtained.

2. The medical ligation tool according to item 1, wherein the flexible wire forming the ligation loop portion has a main orientation axis of constituent molecules substantially oriented in an axial direction of the wire by a stretching process. Ligature.
3. The medical ligature according to item 1, wherein the flexible wire forming the ligation loop portion is made of a synthetic resin mainly composed of polyamide.
4). 2. The medical ligation device according to claim 1, wherein the flexible wire forming the ligation loop portion is made of a synthetic resin mainly composed of polyolefin.
5. 2. The medical ligation tool according to claim 1, wherein the flexible wire forming the ligation loop portion is made of a synthetic resin mainly composed of polyethylene terephthalate.
6). 2. The medical ligation tool according to claim 1, wherein the material of the flexible wire forming the ligation loop portion is made of a synthetic resin mainly composed of fluorine.

Sectional drawing of the front end side part of the ligation apparatus which loaded the medical ligation tool which concerns on 1st Embodiment. Explanatory drawing of the medical ligation tool which concerns on 1st Embodiment. Explanatory drawing of the manufacturing method of the loop wire of the medical ligation tool which concerns on 1st Embodiment. Explanatory drawing of the medical ligation tool which concerns on the modification of 1st Embodiment. Explanatory drawing of the manufacturing method of the loop wire of the medical ligation tool which concerns on the modification of 1st Embodiment. The perspective view of the ligation tool shape holder which hold | maintains the ligation tool when sterilizing the medical ligation tool which concerns on this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 2 ... Medical ligation tool, 11 ... Insertion part, 13 ... Sheath 15 ... Hook, 21 ... Flexible wire, 23 ... Stopper 24 ... Loop for ligation, 25 ... Loop part for hook attachment 31 ... Lie shape holder 33 ... Loop groove, 34 ... Fixing claw

Claims (7)

  A medical ligation device in which a ligation loop portion for ligating a tissue site in a body cavity is formed by a flexible synthetic resin wire material, the device comprising a holder body, and the wire body of the ligation loop portion in the holder body Is arranged and held in a shape corresponding to the shape of the loop portion.   A flexible synthetic resin wire formed in a loop shape is used as a base material, and the base material is made elongated by applying a stretching process to the base material, and the constituent molecules of the synthetic resin constituting the wire material A medical ligation tool in which a main ligation axis is oriented in a direction substantially coinciding with the axial direction of the wire to form a ligation loop portion for ligating a tissue site in a body cavity, having a holder body, and holding this A medical ligation tool characterized in that the wire material of the ligation loop portion is arranged and held in a shape corresponding to the shape of the loop portion in the tool body.   The holder main body is fitted in the loop groove, the loop groove for fitting the wire material of the ligation loop part, and arranging and holding the wire material of the ligation loop part in a shape corresponding to the shape of the loop part. The medical ligation tool according to claim 1, further comprising: a fixing claw that prevents the wire rod from slipping out of the ligation loop portion.   The medical device according to claim 1, 2 or 3, wherein the holder main body has a flexibility that can be easily deformed when the ligation loop portion is removed. Ligature.   The medical ligation tool according to claim 1, 2, 3, or 4, wherein the synthetic resin wire is formed into an endless loop without a seam.   A ligature tool shape holding tool for holding a medical ligation tool in which a ligation loop portion for ligating a tissue site in a body cavity is formed by a flexible synthetic resin wire material, the ligature tool shape holding tool having a holder main body, and the holding tool A ligature shape holder, wherein a wire rod of the ligation loop portion is arranged and held in a shape corresponding to the shape of the loop portion on a main body.   A flexible synthetic resin wire formed in a loop shape is used as a base material, and the base material is made elongated by applying a stretching process to the base material, and the constituent molecules of the synthetic resin constituting the wire material A ligature shape holder for holding a medical ligation tool in which a main ligation axis is oriented in a direction substantially coinciding with the axial direction of the wire to form a ligation loop portion for ligating a tissue site in a body cavity. A ligature shape holder having a tool body, wherein the wire body of the ligation loop portion is arranged and held in the holder body in a shape corresponding to the shape of the loop portion.

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