WO2017183174A1

WO2017183174A1 - Ligation device

Info

Publication number: WO2017183174A1
Application number: PCT/JP2016/062722
Authority: WO
Inventors: 尚也杉本; 和敏熊谷
Original assignee: オリンパス株式会社
Priority date: 2016-04-22
Filing date: 2016-04-22
Publication date: 2017-10-26
Also published as: JPWO2017183174A1

Abstract

The purpose of the present invention is to provide an optimum ligation device in a case where the left atrial appendage is on the surface of the heart having a convex shape with an especially small curvature. This ligation device (1) includes: a ligature (5) which has a contractible looped portion; an elongated shaft (2); and a ligature expanding portion (3) which is fixed to the leading end of the shaft (2) and retains, in a releasable manner, the ligature (5) with the looped portion of the ligature (5) expanded. In a free state, the ligature expanding portion (3) extends along a deployment plane that intersects a longitudinal axis of the shaft (2) and the deployment plane is bent in a direction opposite the shaft (2).

Description

Ligation device

The present invention relates to a ligation device.

It is known that when atrial fibrillation occurs, blood flow in the left atrial appendage decreases due to irregular contraction of the atrium, and blood clots are likely to occur in the left atrial appendage. Since thrombi cause cerebral infarction, a ligation device has been devised to close the left atrial appendage by ligating the root of the left atrial appendage with a thread in order to prevent thrombus formation and scattering (for example, Patent Document 1, Patent) Reference 2).
The left atrial appendage is usually attached to the left atrium and is located in the upper left of the heart. The base part of the left atrial appendage, that is, the connection part with the heart has a substantially elliptical cross-sectional shape, and the opening size is about 30 mm in the longitudinal direction and about 10 mm in the lateral direction. The width of the left atrial appendage is about 45 mm or less.

Special table 2010-527697 Special table 2010-523171

The left atrial appendage is present on the convex heart surface, and the shape of the left atrial appendage and heart varies from person to person. When the left atrial appendage is present on the convex heart surface having a particularly small curvature, the ligating devices of

Patent Documents

1 and 2 may take time to place the ligature loop at the base of the left atrial appendage.

The present invention has been made in view of the above-described circumstances, and an object thereof is to provide an optimal ligation device when the left atrial appendage is present on a convex heart surface having a particularly small curvature.

In one embodiment of the present invention, a ligature including a loopable portion that can be contracted, an elongated shaft, and fixed to a distal end of the shaft, the looped portion of the ligature is held in a releasable state. A thread expansion portion, and in a free state, the thread expansion portion extends along a deployment surface that intersects the longitudinal axis of the shaft, and the deployment surface is recessed in a direction opposite to the shaft. A curved ligation device.

According to this aspect, the elongated shaft is inserted into the body from the yarn expansion portion side through a sheath or the like penetrating from the lower part of the xiphoid process to the inside of the pericardium, and the yarn is expanded from the sheath end in the pericardium. When the part is exposed in the pericardium, the thread expansion part expands to a free state, and the looped part of the ligature thread that is held is expanded, and along the development surface that intersects the longitudinal axis of the shaft. It becomes the form which extends.

By placing the left atrial appendage inside the expanded loop-shaped portion and pushing the shaft, the loop-shaped portion can be disposed near the base of the left atrial appendage. In this case, since the thread expansion portion has a shape along the development surface that is curved so as to be concave in the direction opposite to the shaft, it has a convex curved surface shape on the surface of the heart to which the root of the left atrial appendage is connected. It is arranged along. At this time, the left atrial appendage arranged on the inner side can be ligated by releasing the loop-like portion of the ligature from the yarn expansion portion and contracting it. As a result, an optimal ligation device can be provided when the left atrial appendage is present on a convex heart surface having a particularly small curvature.

In the above aspect, the yarn extending portion includes a proximal end portion connected to the shaft and a distal end portion disposed at a position distant from the shaft, and the development surface is substantially the same along the proximal end portion. You may provide the 1st surface which consists of a plane, and the 2nd surface which consists of a substantially plane which cross | intersects this 1st surface and follows the said front-end | tip part.
By doing in this way, the 1st surface and 2nd surface which consist of a substantially plane which mutually cross | intersects form the thread expansion part curved in the direction opposite to a shaft. Also by this, the thread expansion portion can be placed along the surface of the heart having a convex curved surface shape.

Moreover, in the said aspect, you may hold | maintain the said thread expansion part in the state expanded so that the maximum internal diameter of the said loop-shaped part of the said ligature may be about 35 mm to 50 mm.
In this way, the left atrial appendage having a width of approximately 35 mm to 50 mm can usually be easily accommodated in the loop-shaped portion and ligated.

Moreover, in the said aspect, the said thread expansion part may be provided with the substantially parallel parallel part which opened the substantially constant space | interval between the base end and front-end | tip of this thread expansion part.
In this manner, a parallel part is arranged so as to sandwich the left atrial appendage having a flat shape, and the left atrial appendage can be tightened as soon as the ligature is released from the thread expansion part. Can be held.
Moreover, in the said aspect, the said parallel part may have a longitudinal direction, and may curve to the longitudinal direction of the said expansion | deployment surface.

Moreover, in the said aspect, the said thread expansion part may be formed in substantially cyclic | annular form.
By doing in this way, a ligature can be supported by the thread expansion part over substantially the entire circumference around the left atrial appendage. In particular, if the thread expansion portion is circular, the thread expansion portion can be disposed at the base of the left atrial appendage without selecting the position of the shaft relative to the left atrial appendage.

Moreover, in the said aspect, the said thread expansion part may incline with respect to the said longitudinal axis of the said shaft around the axis line extended to the front-end | tip from the base end of this thread expansion part.
The roots on both sides of the left atrial appendage thickness direction that protrude from the heart surface and extend along the heart surface toward the apex are viewed from the shaft that is introduced along the heart surface into the pericardium from the apex side, It is arranged at a position separated in the front-rear direction by the thickness of the left atrial appendage. By doing in this way, the thread expansion part can be brought close to the surface of the heart on both sides in the thickness direction of the left atrial appendage.

According to the present invention, when the left atrial appendage is present on the convex heart surface having a small curvature, the loop of the ligature is easily arranged at the root of the left atrial appendage.

It is a whole lineblock diagram showing the ligation device concerning one embodiment of the present invention. FIG. 2 is an enlarged perspective view showing a yarn expansion portion of the ligating device of FIG. 1. It is a side view which shows the state which inserted the left atrial appendage in the thread expansion part of the ligation device of FIG. It is an enlarged view which shows the holding | maintenance part and frame part of the thread | yarn expansion part of the ligation device of FIG. It is a top view which shows the state which inserted the left atrial appendage in the thread expansion part of the ligation device of FIG. It is a top view which shows the state which inserted the left atrial appendage in the thread expansion part of the 1st modification of the ligation device of FIG. It is a top view which shows the 2nd modification of the ligation device of FIG. It is a side view which shows the state which inserted the left atrial appendage in the thread expansion part of the ligation device of FIG.

A ligation device 1 according to an embodiment of the present invention will be described below with reference to the drawings.
As shown in FIG. 1, the ligating device 1 according to the present embodiment is provided on an elongated cylindrical shaft 2, a thread expansion portion 3 fixed to the distal end of the shaft 2, and a proximal end side of the shaft 2. The operation unit 4 and a ligature 5 that is disposed through a through hole (not shown) formed through the shaft 2 in the longitudinal direction and pulled by the operation unit 4 are provided.

The shaft 2 is inserted from the outside of the body to the inside of the pericardium via a sheath or the like (not shown) that penetrates from the lower part of the xiphoid process to the inside of the pericardium, and operates the proximal end of the shaft 2 arranged outside the body. By doing so, it is made of a relatively hard material so that the position and posture of the thread expansion portion 3 fixed to the tip can be adjusted.

The yarn expanding portion 3 includes, for example, a holding portion 6 formed in an approximately U shape by an elastic material such as resin, and a frame portion (base end) for fixing the U-shaped open end of the holding portion 6 to the shaft 2. Part) 7. By the U-shaped holding portion 6 and the frame portion 7, the yarn expanding portion 3 has a substantially oval annular shape fixed to the tip of the shaft 2.

That is, in the yarn expansion portion 3, one end (base end portion) of an oval longitudinal axis is fixed to the shaft 2. Further, the holding portion 6 of the yarn expanding portion 3 connects the two parallel portions 8 extending linearly from one end of the oval longitudinal axis to the other end side, and the tip end side of the parallel portion 8. And a distal end portion 9 which is curved.

A plane (first surface) A formed by the two parallel portions 8 extends in a direction intersecting with the longitudinal axis B of the shaft 2 at an angle θ1 in a free state, as shown in FIG. A frame portion 7 is attached to the frame. Further, the distal end portion 9 is along a plane (second surface) C that is inclined at an angle θ3 in a direction opposite to the shaft 2 with respect to the first surface A formed by the two parallel portions 8 in a free state. Is stretched to extend.

Thereby, in the free state, the thread expansion part 3 has a form which curves so that it may become concave on the opposite side to the shaft 2 along the development | deployment surface provided with the 1st surface A and the 2nd surface C. ing.
In the present embodiment, as shown in FIGS. 2 and 3, the yarn expanding portion 3 is inclined at an angle θ2 in one direction around an axis parallel to the oval longitudinal axis.

The parallel part 8 of the yarn expansion part 3 has a length of about 30 mm, and the tip part 9 inclined with respect to the parallel part 8 has a length of about 15 mm. Further, the interval between the parallel portions 8 is a constant interval of about 10 mm. Thereby, generally the left atrial appendage X which has a width of 45 mm or less can be easily inserted into the thread expansion portion 3.

As shown in FIG. 2, the ligature 5 is provided with a loop portion (loop portion) 5a formed by a knot (not shown) at one end. The loop-shaped portion 5a is configured to be contractible by pulling the other end of the ligature yarn 5.
As shown in FIGS. 2 and 4, the holding portion 6 of the yarn expanding portion 3 is provided with a containing hole 10 that accommodates a part of the looped portion of the ligature yarn 5 over the entire length. Is provided with a slit 11 that opens radially inward of the yarn expansion portion 3.

The slit 11 is closed so that the ligature 5 accommodated in the accommodation hole 10 does not fall off, and tension is applied to the ligature 5 by pulling the other end of the ligature 5, so that the loop-shaped portion 5 a is formed. When contracted, the loop-shaped portion 5 a is drawn out of the accommodation hole 10 through the slit 11. In other words, the yarn expanding portion 3 holds the looped portion 5a of the ligature yarn 5 in the expanded state by being accommodated in the accommodating hole 10, and the left atrial appendage X can be easily inserted into the looped portion 5a. Can be done.

Then, when the left atrial appendage X is inserted inside the thread expanding portion 3 and the thread expanding portion 3 is disposed near the base of the left atrial appendage X, a traction force is applied to the other end of the ligature thread 5 to The loop-shaped part 5a arranged around the atrial appendage X is contracted and pulled inward through the slit 11, and the root of the left atrial appendage X can be directly ligated by the loop-shaped part 5a.

The operation of the ligating device 1 according to this embodiment configured as described above will be described below.
In order to ligate the left atrial appendage X of the heart using the ligation device 1 according to the present embodiment, the thread expansion portion passes through an inner hole of a sheath or the like inserted so as to penetrate from the lower part of the xiphoid process into the pericardium. The shaft 2 is inserted into the pericardium from the 3rd side.

In the sheath, the yarn expanding portion 3 is straightened by elastic deformation by the inner hole wall surface of the sheath, and is constrained in a state where the interval between the two parallel portions 8 is also narrowed. Thereby, the inside of the inner hole of a thin sheath can be inserted toward the pericardium.

When the thread expansion portion 3 is exposed from the distal end opening of the sheath into the pericardium, the free state is released from the restraint by the inner wall of the inner hole of the sheath, so that the interval between the two parallel portions 8 is widened, and By the brazing of the frame portion 7, the first surface A formed by the two parallel portions 8 is inclined with respect to the longitudinal axis B of the shaft 2 at an angle θ1 in one direction. At this time, the tip 9 of the yarn expanding portion 3 also extends along the second surface C inclined at an angle θ3 in the direction opposite to the shaft 2 with respect to the first surface A by brazing the holding portion 6. To restore.

Thereby, the loop-shaped part 5 a of the ligature 5 held in the accommodation hole 10 of the holding part 6 is held in a state of being expanded to the same size as the holding part 6.
In this state, the other end of the shaft 2 is operated outside the body to bring the thread expansion portion 3 close to the left atrial appendage X from the apex side, and the left atrial appendage X is inserted inside the holding portion 6 of the thread expansion portion 3. . At this time, as shown in FIG. 4 and FIG. 5, while pulling the distal end of the left atrial appendage X with the gripping forceps 12 inserted separately, the shaft 2 is pushed to push the thread expanding portion 3, thereby It can be placed near the base of the left atrial appendage X.

Thus, according to the ligating device 1 according to the present embodiment, the yarn expanding portion 3 is curved so as to be recessed in the opposite direction to the shaft 2 due to the first surface A and the second surface C intersecting each other. As shown in FIG. 5, the loop-shaped portion 5a of the ligature 5 is disposed at a position closer to the root of the left atrial appendage X, as shown in FIG. Can be arranged. As a result, the root of the left atrial appendage X can be ligated by the loop-shaped portion 5a of the ligature 5 released from the yarn expansion portion 3. As a result, an optimal ligation device can be provided when the left atrial appendage is present on a convex heart surface having a particularly small curvature.

In addition, according to the present embodiment, the yarn expansion portion 3 is inclined at an angle θ2 with respect to the shaft 2 around an axis parallel to the longitudinal axis thereof, so that the shaft 2 has a shape as shown in FIG. When viewed from the base end side, one parallel portion 8 constituting the yarn expansion portion 3 is disposed on the near side, and the other parallel portion 8 is disposed on the back side. Thereby, the parallel part 8 of the thread expansion part 3 at the tip of the shaft 2 arranged along the surface of the heart from the apex side can be brought close to the boundary between the left atrial appendage X and the heart surface. The loop-shaped portion 5a of the ligature 5 can be disposed at a position closer to the root of the atrial appendage X.

Moreover, according to this embodiment, since the substantially U-shaped holding part 6 has accommodated the loop-shaped part 5a in the accommodation hole 10 over the entire circumference, the left atrial appendage X is inserted into the holding part 6. The loop portion 5a is not caught by the left atrial appendage X during operation, and the operation can be facilitated.

Further, since the thread expansion portion 3 is formed in a substantially oval shape or a substantially rectangular shape by the two parallel portions 8 arranged substantially in parallel with a predetermined interval, the left atrial appendage X inserted between them Can be arranged at positions adjacent to each other in the thickness direction. Furthermore, since the inner diameter dimension of the longitudinal direction of the thread expansion portion 3 is set to about 35 mm to 50 mm, a general left atrial appendage X can be easily inserted, and it is greatly separated from the surface in the width direction of the inserted left atrial appendage X. The loop-shaped part of the front-end | tip part 9 can be arrange | positioned in the position which is not.

As a result, when pulled, the loop-shaped portion 5a pulled out from the accommodation hole 10 through the slit 11 can perform ligation of the left atrial appendage.

In addition, in this embodiment, although illustrated about the case where the thread expansion part 3 has a form which curves so that it may bend along the expansion | deployment surface containing the 1st surface A and the 2nd surface C which mutually cross | intersect, Instead of this, as shown in FIG. 6, it may have a form that curves along a development surface composed of a curved surface that curves continuously.

In the present embodiment, the thread expansion portion 3 is inclined with respect to the shaft 2 around the axis parallel to the longitudinal axis. Instead, the longitudinal axis B of the shaft 2 and the thread expansion It may be orthogonal to a plane including the longitudinal axis of the portion 3.

Further, in the present embodiment, the case where the yarn extending portion 3 has an oval shape is illustrated, but instead, it may be formed in a substantially circular shape as shown in FIG. By doing in this way, there exists an advantage that arrangement | positioning of the shaft 2 with respect to the left atrial appendage X can be selected arbitrarily.

That is, in particular, as shown in FIG. 2, when the positional relationship between the two parallel portions 8 is arranged at different positions in the longitudinal direction of the shaft 2, the parallel portions 8 arranged on the near side are arranged. It is necessary to arrange the shaft 2 so as to be arranged between the heart and the left atrial appendage X. By making the thread expansion portion 3 substantially circular, as shown in FIG. 8, the curved tip portion 9 is inserted between the heart and the left atrial appendage X, and the frame portion 7 is pushed by the force of pushing the shaft 2. By curving and disposing the proximal end portion on the back side, the loop-shaped portion of the distal end portion 9 can be disposed at a position closer to the root of the left atrial appendage X.

DESCRIPTION OF SYMBOLS 1 Ligation device 2 Shaft 3 Yarn expansion part 5 Ligation thread 5a Loop-shaped part (loop-shaped part)
7 Frame (base end)
8 Parallel part 9 Tip part A Plane (first surface)
B Longitudinal axis C Plane (second surface)

Claims

A ligature comprising a loopable portion that can be tightened;
An elongated shaft;
A thread expansion portion that is fixed to the tip of the shaft and holds the looped portion of the ligature thread in a releasable state; and
A ligation device in which the yarn expanding portion extends in a free state along a deployment surface that intersects the longitudinal axis of the shaft, and the deployment surface is curved so as to be concave in a direction opposite to the shaft.
The yarn extending portion includes a proximal end portion connected to the shaft and a distal end portion disposed at a position away from the shaft;
The said expansion | deployment surface is equipped with the 1st surface which consists of a substantially plane which follows the said base end part, and the 2nd surface which consists of a substantially plane which cross | intersects this 1st surface and follows the said front-end | tip part. Ligation device.
The ligating device according to claim 1 or 2, wherein the yarn expanding portion holds the loop-shaped portion of the ligature yarn in an expanded state so that a maximum inner diameter is about 35 mm to 50 mm.
The ligation device according to any one of claims 1 to 3, wherein the yarn extending portion includes a substantially parallel parallel portion having a substantially constant interval between a base end and a distal end of the yarn expanding portion.
The ligation device according to claim 4, wherein the parallel portion has a longitudinal direction and is curved in the longitudinal direction of the development surface.
The ligating device according to any one of claims 1 to 5, wherein the yarn extending portion is formed in a substantially annular shape.
The ligation device according to any one of claims 1 to 6, wherein the yarn extending portion is inclined with respect to the longitudinal axis of the shaft around an axis extending from a proximal end of the yarn extending portion to a distal end.