JP7690169B2 - Suture device - Google Patents

Description

The present invention relates to a suturing device.

Endoscopic submucosal dissection (ESD) is a treatment method in which a high-frequency scalpel or the like is used to cut off a lesion inside the stomach or other organ. Patent Document 1 (Patent Publication No. 6233147) describes a retention snare and a retention snare ligation device as a technique for preventing bleeding from the cut surface of the lesion.

The retention snare described in Patent Document 1 has a nylon wire and a clamping ring. The nylon wire on one side of the clamping ring forms a first loop. The nylon wire on the other side of the clamping ring forms a second loop. The first loop is larger than the second loop. The retention snare described in Patent Document 1 is positioned so that the first loop surrounds the resection surface of the lesion. The first loop is clipped to the body tissue surrounding the resection surface of the lesion.

The retention snare ligation device described in Patent Document 1 is inserted into a guide tube for an endoscope. After insertion into the guide tube for an endoscope, the retention snare ligation device described in Patent Document 1 narrows the diameter of the first loop by moving the tightening ring from the second loop side toward the first loop side. As the diameter of the first loop narrows, the internal tissue surrounding the resection surface of the lesion is also sutured, preventing bleeding from the resection surface of the lesion.

Patent No. 6233147

However, when suturing using the retention snare and retention snare ligation device described in Patent Document 1, it is necessary to hook the hook of the retention snare ligation device described in Patent Document 1 onto the second loop in order to slide the tightening ring after retaining the retention snare described in Patent Document 1 near the resection surface of the lesion, and there is room for improvement in operability when suturing the internal tissue around the resection surface of the lesion.

The present invention has been made in consideration of the problems of the prior art as described above. More specifically, the present invention provides a suturing device with improved operability when suturing the body tissue surrounding the resection surface of the lesion.

The suture device of the present invention comprises a loop line, a cable, and a sheath. The loop line has a first end and a second end opposite the first end. The loop line has an annular loop portion having a start point and an end point, respectively, at two separate portions of the loop line between the first end and the second end. The cable is attached to at least the first end. The sheath has a third end and a fourth end opposite the third end. The loop line and the cable are arranged within the sheath such that the loop portion protrudes from the third end side and the cable partially protrudes from the fourth end side. The loop portion is reduced in diameter by pulling the cable out from the fourth end side.

The suture device may further include a stopper. The stopper may be slidably attached to two separate portions of the loop line between the first end and the second end, thereby providing the loop line with a loop portion. The stopper may be disposed between the loop portion and the third end. The stopper may be unable to be inserted into the sheath from the third end side. The loop portion may be reduced in diameter by pulling the cable from the fourth end side with the stopper in contact with the third end.

In the suture device, a cable may be attached to the first end and the second end. In the suture device, the length of the loop line between the stopper and the cable may be 100 mm or more.

In the suture device, the stopper may have a resin layer around the loop line and a tubular member covering the resin layer. The tubular member may be crimped to the loop line with the resin layer interposed therebetween.

In the suture device, the loop line may be made of nylon, polyester, polypropylene, polytetrafluoroethylene, polybutester, or polyethylene. In the suture device, the cable may be made of a material having a higher Young's modulus than the material constituting the loop line. In the suture device, the cable may be made of stainless steel.

The suture device described above can improve operability when suturing the internal tissue surrounding the resection surface of the lesion.

FIG. 1 is a top view of suturing device 100. 2 is a plan view of the suturing device 100 with the sheath 40 omitted. FIG. 3 is a cross-sectional view taken along line III-III in FIG. 2. 1 is a plan view of a suturing device 100A with the sheath 40 omitted. FIG. 13 is a plan view of the suturing device 100B with the sheath 40 omitted. FIG. 13 is a schematic diagram showing a method of using the suturing device 100 with the outer tube 200. FIG. 2 is a cross-sectional view of the outer cylinder 200 in the vicinity of a fifth end 200a of the outer cylinder 200. FIG.

Details of the embodiments of the present invention will be described with reference to the drawings. In the following drawings, the same or corresponding parts will be given the same reference symbols, and redundant explanations will not be repeated.

(Configuration of the suturing device according to the embodiment)
The configuration of a suturing device according to an embodiment (referred to as "suturing device 100") will be described below.

Figure 1 is a plan view of the suturing device 100. Figure 2 is a plan view of the suturing device 100 without illustrating the sheath 40. Figure 3 is a cross-sectional view taken along line III-III in Figure 2. As shown in Figures 1 and 2, the suturing device 100 has a loop wire 10, a cable 20, a stopper 30, and a sheath 40.

The loop wire 10 is a linear member. The loop wire 10 is a thread made of a flexible material. Specific examples of materials that make up the loop wire 10 include nylon, polyester, polypropylene, polytetrafluoroethylene, polybutester, and polyethylene. The outer diameter of the loop wire 10 is, for example, 0.4 mm. The loop wire 10 has a first end 10a and a second end 10b. The second end 10b is the end opposite the first end 10a.

The cable 20 is a linear member. The cable 20 is made of a material having a higher Young's modulus than the material constituting the loop wire 10. The cable 20 is, for example, a twisted wire made of a metal material. A specific example of the material constituting the cable 20 is stainless steel.

One end of the cable 20 is attached to the first end 10a of the loop wire 10. More specifically, one end of the cable 20 and the first end 10a of the loop wire 10 are placed inside the tubular member 21, and the tubular member 21 is crimped, thereby attaching one end of the cable 20 to the first end 10a of the loop wire 10. The tubular member 21 is formed, for example, from a metal material. A specific example of the metal material constituting the tubular member 21 is stainless steel.

The stopper 30 is slidably attached to two separate portions of the loop line 10 between the first end 10a and the second end 10b. These two portions are referred to as the first portion 11 and the second portion 12. The second portion 12 is closer to the second end 10b than the first portion 11. The second portion 12 is farther from the second end 10b. A knot is provided in the portion of the loop line 10 between the second portion 12 and the second end 10b. This knot prevents the loop line 10 from slipping out of the stopper 30.

The loop line 10 has a loop portion 13. The loop portion 13 is circular, starting and ending at the first portion 11 and the second portion 12, respectively.

The stopper 30 has a resin layer 31 and a tubular member 32. The resin layer 31 is around the loop wire 10 (first portion 11, second portion 12). The resin layer 31 is a layer formed of a resin material. A specific example of the resin material constituting the resin layer 31 is silicone rubber. The tubular member 32 covers the resin layer 31. From another perspective, the loop wire 10 (first portion 11, second portion 12) and the resin layer 31 are inside the tubular member 32. The tubular member 32 is formed of, for example, a metal material. A specific example of the metal material constituting the tubular member 32 is stainless steel. The tubular member 32 is crimped to the loop wire 10 (first portion 11, second portion 12) with the resin layer 31 interposed therebetween.

The length of the loop wire 10 between the stopper 30 and the cable 20 is defined as length L. Length L is, for example, 100 mm or more. Length L may be 150 mm or more. Length L is measured when the diameter of the loop portion 13 (the width of the loop portion 13 in the longitudinal direction) is 35 mm.

The sheath 40 is a tubular member. The sheath 40 is made of, for example, a resin material. A specific example of the resin material that constitutes the sheath 40 is fluororesin. The sheath 40 has a third end 40a and a fourth end 40b. The fourth end 40b is the end opposite the third end 40a.

The loop wire 10 and the cable 20 are disposed within the sheath 40. However, the loop portion 13 protrudes from the third end 40a side of the sheath 40, and a part of the cable 20 protrudes from the fourth end 40b side of the sheath 40.

The stopper 30 is disposed between the third end 40a of the sheath 40 and the loop portion 13. The stopper 30 cannot be inserted into the sheath 40 from the third end 40a side. More specifically, the outer diameter of the stopper 30 on the third end 40a side of the sheath 40 is larger than the inner diameter of the sheath 40. The outer diameter of the sheath 40 is smaller than the inner diameter of the forceps channel of the endoscope, for example. The sheath 40 has a length that allows it to be inserted into the forceps channel of the endoscope.

When the cable 20 is pulled out from the fourth end 40b side of the sheath 40, the stopper 30 moves toward the third end 40a of the sheath 40 and comes into contact with the third end 40a of the sheath 40. Since the stopper 30 cannot be inserted into the inside of the sheath 40 from the third end 40a side, when the cable 20 is pulled out further with the stopper 30 in contact with the third end 40a of the sheath 40, the loop wire 10 is pulled into the inside of the sheath 40, and the diameter of the loop portion 13 is reduced.

(Method of using the suturing device according to the embodiment)
The method of using the suturing device 100 will now be described.

When using the suturing device 100, first, a guide sheath is prepared. The loop portion 13 is inserted into the guide sheath. Note that other parts of the suturing device 100 do not need to be placed inside the guide sheath.

Secondly, when using the suturing device 100, the guide sheath into which the loop portion 13 is inserted is placed at the entrance of the forceps channel of the endoscope. In this state, the suturing device 100 is pushed in, so that the suturing device 100 is inserted into the forceps channel of the endoscope. Note that since the loop wire 10 is highly flexible, it is difficult to insert the loop portion 13 from the entrance of the forceps channel of the endoscope as is, but by using a guide sheath, the loop portion 13 can be easily inserted into the forceps channel of the endoscope. The suturing device 100 is moved in the forceps channel of the endoscope until the loop portion 13 is placed in the internal tissue (e.g., the gastric mucosa) around the resection surface of the lesion.

Thirdly, when using the suture device 100, the loop portion 13 is fixed to the body tissue surrounding the resection surface of the lesion by using an endoscopic clip. This fixing is performed, for example, at multiple points.

Fourthly, when using the suturing device 100, while holding the sheath 40, the cable 20 is pulled out from the fourth end 40b of the sheath 40. This causes the loop portion 13 to shrink in diameter. As the loop portion 13 shrinks in diameter, the internal tissue around the resection surface of the lesion is enclosed by the loop portion 13 and sutured.

After the internal tissue around the resection surface of the lesion is sutured by the loop portion 13, the portion of the loop line 10 on the first end 10a side of the loop portion 13 is cut by scissors forceps, and the loop portion 13 and the stopper 30 are left in the body. The other parts of the suture device 100 are then removed from the body. Note that the endoscopic clip that fixed the loop portion 13 to the internal tissue around the resection surface of the lesion naturally comes off over time and is expelled from the body together with the loop portion 13 and the stopper 30 that were left in the body.

(Effects of the suturing device according to the embodiment)
The effects of the suturing device 100 will be described below.

In the suturing device 100, after the loop portion 13 is clipped to the internal tissue surrounding the resection surface of the lesion, the cable 20 is manually pulled out from the fourth end 40b of the sheath 40, thereby reducing the diameter of the loop portion 13 and suturing the internal tissue surrounding the resection surface of the lesion, thereby improving operability when suturing the internal tissue surrounding the resection surface of the lesion.

The suturing device 100 does not require any other device (e.g., a device having a hook for reducing the diameter of the loop portion) to reduce the diameter of the loop portion 13, and the device configuration for suturing the internal tissue around the resection surface of the lesion can be simplified.

In the suture device 100, the loop line 10 is connected to the user's hand via the cable 20, but since the loop line 10 is made of a flexible material and has a length L of, for example, 100 mm or more, the loop portion 13 is independent of the movement of the endoscope. Therefore, the endoscope can be moved without changing the position of the loop portion 13, and the endoscope can be moved to a position with good visibility to proceed with the procedure.

In the suturing device 100, the loop wire 10 is crimped by the tubular member 32 via the resin layer 31, so that a moderate frictional force acts between the stopper 30 and the loop wire 10. Therefore, when the cable 20 is pulled out from the fourth end 40b side of the sheath 40 with the stopper 30 in contact with the third end 40a of the sheath 40, the loop wire 10 slides against the stopper 30, but in other cases, the loop wire 10 is difficult to move against the stopper 30. Therefore, the suturing device 100 can achieve both operability during suturing and prevention of loosening of the loop portion 13 (shape retention of the loop portion 13).

In the suture device 100, the cable 20 is formed from a material with a higher Young's modulus than the material constituting the loop wire 10. As a result, the total elongation of the loop wire 10 and the cable 20 when the internal tissue surrounding the resection surface of the lesion is sutured by the loop portion 13 is suppressed, so the tightening load by the loop portion 13 can be reduced.

(Variation 1)
The suturing device 100 according to the first modification (referred to as "suturing device 100A") will be described below. Here, differences from the suturing device 100 will be mainly described, and overlapping descriptions will not be repeated.

Figure 4 is a plan view of the suturing device 100A, with the sheath 40 omitted. As shown in Figure 4, the suturing device 100A has a loop line 10, a cable 20, a stopper 30, and a sheath 40 (not shown). The stopper 30 is attached to two separate portions of the loop line 10 between the first end 10a and the second end 10b, so that the portion of the loop line 10 between the two portions becomes a loop portion 13.

The loop wire 10 and the cable 20 are arranged in the sheath 40 such that the loop portion 13 protrudes from the third end 40a side of the sheath 40 and the cable 20 protrudes from the fourth end 40b side of the sheath 40. In these respects, the configuration of the suturing device 100A is common to the configuration of the suturing device 100.

However, in the suturing device 100A, both the first end 10a and the second end 10b of the loop wire 10 are attached to one end of the cable 20. In other words, the two loop wires 10 are arranged in parallel between the stopper 30 and one end of the cable 20. In this respect, the configuration of the suturing device 100A differs from the configuration of the suturing device 100. Note that in this case as well, the first end 10a and the second end 10b of the loop wire 10 are attached to one end of the cable 20 by crimping using the tubular member 21.

In the suturing device 100A, as in the suturing device 100, the loop portion 13 is reduced in diameter by pulling out the cable 20 from the fourth end 40b side of the sheath 40, and the internal body tissue around the resection surface of the lesion can be sutured, improving operability when suturing the internal body tissue around the resection surface of the lesion.

In addition, in the suturing device 100A, both the first end 10a and the second end 10b of the loop wire 10 are connected to one end of the cable 20, so that, compared to the suturing device 100, even if the length of the cable 20 pulled out from the fourth end 40b side of the sheath 40 is the same, the diameter of the loop portion 13 can be reduced more.

(Variation 2)
The suturing device 100 according to the second modification (referred to as "suturing device 100B") will be described below. Here, differences from the suturing device 100 will be mainly described, and overlapping descriptions will not be repeated.

5 is a plan view of the suturing device 100B with the sheath 40 omitted. As shown in FIG. 5, the suturing device 100A has a loop line 10, a cable 20, and a sheath 40 (not shown). The loop line 10 has a loop portion 13 that starts and ends at two separate portions of the loop line 10 between the first end 10a and the second end 10b. The loop line 10 and the cable 20 are arranged in the sheath 40 such that the loop portion 13 protrudes from the third end 40a side of the sheath 40 and the cable 20 protrudes from the fourth end 40b side of the sheath 40. In these respects, the configuration of the suturing device 100B is common to the configuration of the suturing device 100.

However, in the suturing device 100A, the second end 10b of the loop wire 10 is tied to the other part of the loop wire 10 to form the loop portion 13. In the suturing device 100B, the second end 10b of the loop wire 10 is tied to the other part of the loop wire 10 so that the loop portion 13 is reduced in diameter by pulling the cable 20 out from the fourth end 40b of the sheath 40. This knot is larger than the inner diameter of the sheath 40. In addition, this knot allows the loop wire 10 to slide and can be fixed at a predetermined fixed position. A specific example of such a knot is the Roeder knot. The suturing device 100B does not have a stopper 30. In these respects, the configuration of the suturing device 100B is different from the configuration of the suturing device 100.

In the suturing device 100B, as in the suturing device 100, the loop portion 13 is reduced in diameter by pulling out the cable 20 from the fourth end 40b side of the sheath 40, and the internal body tissue around the resection surface of the lesion can be sutured, improving operability when suturing the internal body tissue around the resection surface of the lesion.

(Modification of the method of using the suturing device according to the embodiment)
In the above example, when using the suturing device 100, the suturing device 100 is inserted into the forceps channel of an endoscope, but the suturing device 100 can be used in a manner other than by being inserted into the forceps channel of an endoscope.

Figure 6 is a schematic diagram showing a method of using the suturing device 100 using the outer tube 200. As shown in Figure 6, the suturing device 100 may be used by being inserted into the outer tube 200. The outer tube 200 is formed, for example, from a flexible material. An example of a material that constitutes the outer tube 200 is polyvinyl chloride.

The outer tube 200 has an inner diameter that allows the suturing device 100 to be inserted therein. The outer tube 200 has a fifth end 200a and a sixth end 200b. The sixth end 200b is the end opposite the fifth end 200a. The suturing device 100 is inserted into the outer tube 200, for example, from the sixth end 200b side. The outer tube 200 is inserted into the body together with the endoscope by being attached to the endoscope, for example, with tape. Therefore, the suturing device 100 can be used in a manner other than being inserted into the forceps channel of the endoscope. In this case, the outer tube 200 is inserted into the body from the fifth end 200a side.

Figure 7 is a cross-sectional view of the outer tube 200 near the fifth end 200a of the outer tube 200. As shown in Figure 7, the end face of the outer tube 200 at the fifth end 200a is configured as a curved surface. Therefore, when the outer tube 200 is inserted into the body, the end face of the outer tube 200 is less likely to damage the body tissue in the insertion path of the outer tube 200.

The embodiments disclosed herein are illustrative in all respects and should not be considered limiting. The scope of the present invention is indicated by the claims rather than the above embodiments, and is intended to include all modifications within the meaning and scope of the claims.

The above embodiment is particularly advantageously applied to a suturing device for suturing body tissue around the resection surface of a lesion.

100, 100A, 100B suture device, 10 loop line, 10a first end, 10b second end, 11 first part, 12 second part, 13 loop portion, 20 cable, 21 tubular member, 30 stopper, 31 resin layer, 32 tubular member, 40 sheath, 40a third end, 40b fourth end, 200 outer tube, 200a fifth end, 200b sixth end, L length.

Claims (7)

A loop line formed of a flexible material ;
Cables and
and a sheath.
The loop line has a first end and a second end opposite to the first end,
the loop line has a circular loop portion having a start point and an end point at two separate portions of the loop line between the first end and the second end,
the cable is attached to at least the first end;
the sheath has a third end and a fourth end opposite the third end;
the loop wire and the cable are disposed within the sheath such that the loop portion protrudes from the third end side and the cable partially protrudes from the fourth end side,
The loop portion is reduced in diameter by pulling out the cable from the fourth end side ,
Further comprising a stopper;
the stopper is slidably attached to two separate portions of the loop line between the first end and the second end, thereby providing the loop portion on the loop line;
The stopper is disposed between the loop portion and the third end,
The stopper cannot be inserted into the sheath from the third end side,
the loop portion is reduced in diameter by pulling out the cable from the fourth end side with the stopper in contact with the third end,
A suturing device , wherein the length of the loop line between the stopper and the cable when the width of the loop portion is 35 mm is 100 mm or more . The suturing device of claim 1 , wherein the cable is attached to the first end and the second end. the stopper includes a resin layer around the loop line and a tubular member covering the resin layer,
The suturing device according to claim 1 or 2 , wherein the tubular member is crimped to the loop wire with the resin layer interposed therebetween. The suturing device according to any one of claims 1 to 3 , wherein the loop wire is formed from nylon, polyester, polypropylene, polytetrafluoroethylene, polybutester or polyethylene. The suturing device according to any one of claims 1 to 3 , wherein the cable is formed from a material having a higher Young's modulus than a material constituting the loop line. The suturing device of claim 4 or claim 5 , wherein the cable is formed from stainless steel. A loop line formed of a flexible material;
Cables and
and a sheath.
The loop line has a first end and a second end opposite to the first end,
the loop line has a knot at the second end and is slidably tied to a portion of the loop line at the knot located between the first end and the second end;
the loop line has a circular loop portion having a start point and an end point at two separate portions of the loop line between the first end and the second end,
the cable is attached to at least the first end;
the sheath has a third end and a fourth end opposite the third end;
The loop wire and the cable are disposed within the sheath such that the loop portion protrudes from the third end side and the cable partially protrudes from the fourth end side.
And,
The knot cannot be inserted into the sheath from the third end side,
The loop portion is reduced in diameter by pulling out the cable from the fourth end side,
A suturing device , wherein the length of the loop line between the knot and the cable when the width of the loop portion is 35 mm is 100 mm or more .

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