WO2016021592A1

WO2016021592A1 - Introduction assistance instrument with side hole

Info

Publication number: WO2016021592A1
Application number: PCT/JP2015/072071
Authority: WO
Inventors: 保裕高橋; 岡田　浩孝
Original assignee: 株式会社カテラ
Priority date: 2014-08-05
Filing date: 2015-08-04
Publication date: 2016-02-11
Also published as: JP2016036394A

Abstract

An introduction assistance instrument (11) is provided with a tubular body (13) that is inserted into a tubular organ of the human body. A side hole (27) is provided in the peripheral wall of the tubular body (13). A medical instrument (21) can be introduced into a tubular organ via the side hole (27) in the tubular body (13). The tubular body (13) comprises a bendable main body section (23) and a rigid section (25) that is provided to an intermediate part of the main body section (23) and that has higher rigidity than the main body section (23). A slit (29) is formed in the peripheral wall of the rigid section (25) in order to impart flexibility to the rigid section (25).

Description

Introduction aid with side holes

The present invention relates to an introduction assisting device that includes a tubular body that is inserted into a tubular organ of a human body and that can introduce a medical device into the tubular organ through the tubular body.

In an operation in a tubular organ of a human body such as a blood vessel, an introduction assisting instrument such as a sheath introducer as described in Patent Document 1 or a guiding catheter as described in Patent Document 2 is inserted into the tubular organ, and after placement, A therapeutic instrument such as a therapeutic catheter is introduced into the lesion site through the internal passage of the introduction assisting instrument.

When introducing a treatment instrument to a lesion site through an introduction aid placed in a tubular organ, first insert a guide wire for the treatment instrument into the internal passage of the introduction aid placed in the tubular organ. After the distal end reaches the vicinity of the lesion site, the proximal end of the guide wire for the treatment instrument is inserted into the distal end of the treatment instrument such as a treatment catheter, and the treatment instrument is guided along the guide wire for the treatment instrument to the lesion site. invite. At this time, the guide wire for the therapeutic instrument or the therapeutic instrument is advanced by transmitting the pushing force applied to the therapeutic instrument guide wire or the therapeutic instrument from the base end side (the operation side at hand of the doctor) to the distal end. .

When there is a lesion site in a side branch blood vessel that branches off from a blood vessel into which an introduction assisting device is inserted (hereinafter referred to as “introduction blood vessel”), for example, as described in Patent Document 2, between the distal end portion and the main body portion. In addition, using the introduction assisting device having a curved portion formed in advance so that the distal end of the introduction assisting device can be easily oriented toward the entrance of the target side branch blood vessel, the distal end of the introduction assisting device is moved to the side branch blood vessel. Then, a treatment instrument guide wire or a treatment instrument (hereinafter referred to as a guide wire or the like) is extended from the distal end of the introduction assisting instrument and inserted into the side branch vessel for treatment. Patent Document 3 proposes a sheath with a side hole in which a flexible tube of the sheath tube is provided with a side hole smaller than the diameter of the internal passage, and a catheter that cannot pass through the side hole is extended from the distal end opening of the sheath tube. By extending a catheter that can pass through the side hole while extending from the side hole, the catheter can be approached to different side branch vessels using a single sheath tube placed in the introduction vessel.

JP 2003-325671 A JP 2009-22432 A JP 2000-102618 A

A blood vessel such as a human body is bent or meandered in a complicated manner, and an introduction aid, particularly a tubular body part inserted into the blood vessel, is made of a flexible material so that it can be flexibly deformed along such a blood vessel. It is formed. The introduction assisting device is preferably as small as possible in order to facilitate insertion, and the tubular body portion has an inner diameter that is slightly larger than the outer diameter of the catheter that is desired to be introduced into the target site. It is common to use what has.

Accordingly, as in the sheath tube described in Patent Document 3, when a side hole that allows passage of the catheter is provided in the tubular body portion of the introduction assisting device, the tubular body portion is nearly half in the circumferential direction over a predetermined range. The part will be removed. As a result, the strength of the tubular body portion formed of the flexible material is reduced in the portion where the side hole is formed, and it is easy to cause crushing and kinking. The problem arises that the insertion of the catheter into the body part is hindered. Even when a side hole is provided in a tubular body having a sufficient margin with respect to the outer diameter of the tubular body of the introduction assisting device, the side hole is used to facilitate the operation for extending the catheter from the side hole. If is increased, the strength of the tubular body portion provided with the side holes is similarly reduced, and the problem of crushing and kinking is caused. Furthermore, when the rigidity of the tubular body is increased in order to prevent crushing and kinking, there arises a problem that flexibility is sacrificed and the ease of inserting the introduction assisting device into the blood vessel is impaired.

Therefore, the object of the present invention is to solve the problems existing in the prior art, and in the introduction aid with a side hole, the portion provided with the side hole is crushed while ensuring the flexibility of the tubular body inserted into the tubular organ. And to reduce the occurrence of kinks.

In view of the above-described object, the present invention includes a tubular body that is inserted into a tubular organ of a human body, and a side hole is provided in a peripheral wall of the tubular body, and the medical instrument is inserted into the tubular organ through the side hole of the tubular body. A side hole introduction assisting device, wherein the tubular body is provided with a flexible portion that can be bent, and is provided at an intermediate portion of the flexible portion and more than the flexible portion. An introduction assisting device with a side hole is provided that includes a rigid portion having high rigidity, and a slit is formed in a peripheral wall of the rigid portion so as to impart flexibility to the rigid portion.

In the introduction auxiliary device with a side hole, the side hole is provided in a rigid portion having rigidity higher than that of the flexible portion mainly constituting the tubular body, and the strength is reduced by providing the side hole. It is possible to compensate for this by increasing the rigidity of the material, and to reduce the occurrence of crushing and kinking in the portion provided with the side holes. Moreover, by forming a slit in the peripheral wall of the rigid portion where the side hole is provided, the flexibility is increased and the tubular body can be inserted easily.

As one embodiment, each of both ends of the rigid portion and the flexible portion are fixed in a state where one is inserted into the other, and the slit is formed on the peripheral wall of both ends of the rigid portion. The plurality of slits extend in the longitudinal direction and are spaced apart from each other in the circumferential direction. In this case, it is preferable that the plurality of slits extending in the longitudinal direction of the tubular body are tapered toward the central portion of the rigid portion.

As another embodiment, the slit may extend in the circumferential direction or in an oblique direction with respect to the circumferential direction on the peripheral wall of the rigid portion. It is preferable that the slits are a plurality of slits formed at intervals in the direction of the longitudinal axis of the tubular body on the peripheral wall of the rigid portion. In this case, the plurality of slits may be alternately provided on opposite sides of the peripheral wall of the rigid portion.

In the introduction aid with a side hole, each of the end portions of the rigid portion and the flexible portion are fixed in a state where one is inserted into the other, and a plurality of slits extending in the longitudinal direction of the tubular body are provided. You may make it form in the surrounding wall of the both ends of the said rigid part at intervals in the circumferential direction. In this case, the slit is more preferably tapered toward the center of the rigid portion.

The introduction assisting device with a side hole can be, for example, a sheath introducer, a guiding catheter, or a stenosis penetration catheter.

According to the introduction aid with a side hole of the present invention, the side hole is provided in a rigid part having rigidity higher than that of the flexible part mainly constituting the tubular body, thereby preventing the occurrence of crushing and kinking in the part provided with the side hole. Can be reduced. Moreover, since the slit is provided in the rigid portion, the flexibility in the rigid portion provided with the side hole is ensured, and the tubular body can be easily inserted.

It is a top view which shows the whole block diagram of the introduction auxiliary instrument with a side hole by this invention. It is an enlarged view of 1st Embodiment of the rigid part in which the side hole is provided in the introduction assistance instrument with a side. It is an enlarged view which shows the 1st modification of the rigid part shown by FIG. FIG. 6 is an enlarged view showing a second modification of the rigid portion shown in FIG. 2. It is an enlarged view which shows the 3rd modification of the rigid part shown by FIG. It is an enlarged view which shows 2nd Embodiment of the rigid part of the introduction assistance instrument with a side hole. It is explanatory drawing which shows other embodiment of the introduction assistance instrument with a side hole by this invention.

DESCRIPTION OF EMBODIMENTS Hereinafter, embodiments of an introduction assisting device with a side hole according to the present invention will be described with reference to the drawings.
Initially, with reference to FIG. 1, the whole structure of the introduction auxiliary instrument 11 with a side hole by this invention is demonstrated. The introduction assisting device 11 is inserted into a tubular organ such as a blood vessel (hereinafter referred to as an introduction tubular organ), and introduces a medical device 21 such as a guide wire or a treatment device into a side branch tubular organ branched from the introduction tubular organ. It is an instrument to make it easier. The introduction tubular organ is, for example, the ascending aorta or the descending aorta, and the side branch tubular organ is, for example, the brachiocephalic artery, right subclavian artery, right common carotid artery, left common carotid artery, left common carotid artery, left clavicle branching from the ascending or descending aorta Inferior artery, left renal artery, right renal artery. However, these are examples, and the introduction tubular organ and the side branch tubular organ are not limited thereto.

Hereinafter, the introduction assisting device 11 will be described as an example of the introduction assisting device 11 using the sheath introducer. However, the introduction assisting device 11 is not limited to a sheath introducer as long as it is a device for assisting the introduction of the medical device 21 into a tubular organ such as a human body. It can also be used as a catheter.

The introduction auxiliary instrument 11 includes a tubular body 13 extending along the central axis, an instrument body 15, a connection tube 17 extending from the instrument body 15, and a three-way switching valve 19. The tubular body 13 is a flexible tube such as a sheath tube having an internal passage through which the medical instrument 21 can be inserted. The instrument body 15 is a substantially cylindrical member such as a sheath hub formed of an appropriate synthetic resin material, and is externally fixed to the proximal end portion of the tubular body 13. The connection tube 17 is a flexible tube formed of an appropriate synthetic resin material, and is connected to the instrument body 15 so as to communicate with the interior of the instrument body 15. A three-way switching valve 19 is connected to the free end of the connection tube 17 (the end opposite to the end connected to the instrument body 15), and any one of the three ports can be operated by operating the lever. The two can be communicated. Such a three-way switching valve is well-known and has nothing to do with the essential features of the present invention, so a detailed description of its structure is omitted.

The tubular body 13 includes a main body portion (that is, a flexible portion) 23 having flexibility, and a rigid portion 25 that is provided at an intermediate portion of the main body portion 23 and has higher rigidity than the main body portion. . The “intermediate portion” means an arbitrary portion excluding both end portions of the main body portion 23. The main body portion 23 is formed of, for example, a flexible synthetic resin material. On the other hand, the rigid portion 25 is formed of a material having higher rigidity than the material forming the main body portion such as metal or hard synthetic resin. The main body portion 23 and the rigid portion 25 may be connected by welding or an adhesive. Further, when the rigid portion 25 is formed of a synthetic resin material, the main body portion 23 and the rigid portion 25 can be integrally formed from different materials.

FIG. 2 shows a first embodiment of the rigid portion 25 of the introduction assisting device 11 shown in FIG. A side hole 27 is provided in the peripheral wall of the rigid portion 25, and the side hole 27 functions to allow the medical instrument 21 inserted into the tubular body 13 from the instrument body 15 to pass therethrough and extend to the outside. The size and shape of the side hole 27 can be arbitrarily selected as long as the medical instrument 21 can be passed through. can do. A slit 29 extending in the transverse direction is formed on the peripheral wall of the rigid portion 25. Here, the “transverse direction” means a direction crossing the peripheral wall of the rigid portion 25 of the tubular body 13, that is, a circumferential direction of the peripheral wall of the rigid portion 25 of the tubular body 13 or a direction oblique to the circumferential direction. In the embodiment shown in FIG. 1, as shown in detail in FIG. 2, a plurality of slits 29 are formed on the peripheral wall of the rigid portion 25 on the side where the side holes 27 are provided, and the longitudinal direction of the rigid portion 25 is provided. It is provided at intervals in the axial direction. The plurality of slits 29 may be provided on the side opposite to the side where the side holes 27 are provided, as in the first modified form of the rigid portion 25 shown in FIG. As in the second modified form of the rigid portion 25, the stiffened portions 25 may be alternately provided in a staggered manner on opposite sides of the peripheral wall of the rigid portion 25 including the side where the side holes 27 are provided. Further, as shown in FIG. 5, the plurality of slits 29 may be formed to extend obliquely with respect to the circumferential direction.

In the introduction assisting device 11, since the side hole 27 as described above is provided in the tubular body 13, the side hole 27 is arranged in advance at the entrance of the side branch tubular organ, and is inserted into the tubular body 13 from the instrument body 15. By extending the medical device 21 to the outside through the side hole 27, the medical device 21 can be easily introduced into the side branch tubular organ. That is, when the medical device 21 is introduced into the side branch tubular organ, it is not necessary to bring the distal end of the tubular body 13 of the introduction assisting device 11 close to the inlet of the side branch tubular organ or to be inserted into the inlet of the side branch tubular organ. What is necessary is just to arrange | position the side hole 27 provided in the surrounding wall of the tubular body 13 in the entrance of a side branch tubular organ. Therefore, if the introduction assisting device 11 is used, damage to the entrance of the side branch tubular organ due to the distal end of the tubular body 13 can be suppressed.

In the conventional introduction aid with a side hole, since the peripheral wall is removed over a predetermined range in order to provide the side hole in the portion of the tubular body in which the side hole is provided, the strength is lowered, and crushing and kinking are likely to occur. Become. However, in the introduction assisting device 11, the side hole 27 is formed by providing the side hole 27 in the rigid portion 25 having higher rigidity than the main body portion 23 and increasing the rigidity of the material forming the peripheral wall of the rigid portion 25. Therefore, the reduction in strength due to the removal of a part of the peripheral wall of the tubular body 13 is compensated. Therefore, the occurrence of crushing and kinking in the portion where the side hole 27 is provided is reduced.

Furthermore, the rigidity of the rigid portion 25 is enhanced by forming a slit 29 extending in the transverse direction. Therefore, even if the rigid part 25 is included in a part of the tubular body 13, it can be flexibly deformed in accordance with the curvature of the introduction tubular conduit, and the insertion work of the tubular body 13 into the introduction tubular organ is facilitated. It can be carried out.

As described above, the introduction assisting instrument 11 is provided with the side hole 27, and the medical instrument 21 inserted into the tubular body 13 from the instrument body 15 can be extended to the outside from the side hole 27. Therefore, it is not necessary to extend the medical device 21 from the tip of the tubular body 13. Therefore, as shown in FIG. 1, the distal end portion of the tubular body 13 of the introduction assisting device 11 is allowed to pass through the guidewire for the introduction assisting device for guiding the introduction assisting device 11 in the introduction tubular organ. You may connect the front-end | tip member 31 provided with the through-hole (not shown).

If the diameter of the tip opening of the through hole of the tip member 31 is determined so as to allow the passage of the guide wire for the introduction assisting device to the minimum, intrusion of body fluid or the like into the tubular body 13 of the introduction assisting device 11 Can be suppressed. Thus, when the distal end portion of the tubular body 13 of the introduction assisting device 11 is located in the introduction tubular organ and the side hole 27 is located outside the introduction tubular organ, the distal end of the tubular body 13 enters the tubular body 13. For example, there is an effect of suppressing body fluid from entering and flowing back to the outside of the introduction tubular organ through the side hole 27. Further, if the distal end member 31 is formed so that the outer peripheral surface has a tapered shape as it goes toward the distal end side, insertion of the introduced tubular organ through the puncture hole or the like and expansion of the puncture hole or the like can be performed. Has the effect of facilitating.

Next, a method of using the introduction assisting device 11 shown in FIG. 1 will be described.

First, by a Seldinger method or the like, a guide wire (not shown) for an introduction assisting instrument is inserted into the introduction tubular organ using a puncture needle until the tip reaches the vicinity of the entrance of the side branch tubular organ in the introduction tubular organ. Next, the proximal end portion of the guide wire for the introduction assisting device is inserted into the tubular body 13 through the through hole of the tip member 31 connected to the distal end (distal end portion) of the introduction assisting device 11, thereby introducing the introduction assisting device. The tubular body 13 of the introduction assisting device 11 is inserted into the introduction tubular organ along the guide wire. When the introduction assisting device 11 is placed in the introduction tubular organ so that the side hole 27 of the tubular body 13 is positioned in the vicinity of the entrance of the side branch tubular organ branched from the introduction tubular organ, a guide wire for the introduction assisting device is transferred from the introduction assisting device 11. Remove. Since a backflow prevention valve and a three-way switching valve are provided at the proximal end of the instrument body 15 of the introduction assisting instrument 11 and the free end of the connection tube 17, the side hole 27 of the tubular body 13 is inserted into the introduction tubular organ. Even if the introduction assisting instrument 11 is left in the introduced tubular organ in the state where it has been placed, the blood that has entered the lumen of the tubular body 13 from the side hole 27 can be prevented from flowing out of the body. In addition, if the diameter of the tip opening of the through hole of the tip member 31 is determined so as to have a minimum size that allows the guide wire for the introduction aid to pass, the introduction aid can be inserted when the introduction aid 11 is inserted. Even when the distal end portion of the 11 tubular body 13 is located in the introduction tubular organ while the side hole 27 is located outside the introduction tubular organ, the body fluid enters the tubular body 13 from the distal end portion of the tubular body 13. It is possible to suppress intrusion and backflow out of the introduction tubular organ through the side hole 27.

When the tubular body 13 of the introduction assisting device 11 is indwelled, the side hole 27 provided in the tubular body 13 may be disposed at the entrance of the side branch tubular organ, and the distal end of the tubular body 13 is directed to the entrance of the side branch tubular organ. There is no need. Therefore, it is possible to prevent the entrance of the side branch tubular organ from being damaged by the distal end of the tubular organ 13.

Further, the tubular body 13 includes a rigid portion 25 having rigidity higher than that of the main body portion 23. However, the flexibility is enhanced by a plurality of slits 29 provided in the rigid portion 25 extending in the transverse direction. The tubular body 13 can be flexibly deformed according to the shape of the tubular organ, and the operation of inserting the tubular body into the introduced tubular organ is facilitated. Further, since the side hole 27 is provided in the rigid portion 25 having higher rigidity than the main body portion 23 of the tubular body 13, the strength reduction due to the removal of the side wall accompanying the formation of the side hole causes the rigidity of the material forming the rigid portion 25. And the occurrence of crushing and kinking in the portion where the side hole 27 is formed is reduced. Therefore, it is possible to avoid the passage of the medical instrument due to crushing or kinking.

Next, a guide wire for a therapeutic instrument as a medical instrument 21 is passed through a backflow prevention valve (not shown) provided at the proximal end of the instrument main body 15 of the introduction assisting instrument 11 inside the tubular body 13 of the introducing assisting instrument 11. It is inserted into the passage and extends from the side hole 27 toward the entrance of the side branch tubular organ, and further pushed forward until the tip exceeds the lesion site.

Next, the proximal end portion of the guide wire for the treatment instrument is inserted into the distal end of the treatment instrument as another medical instrument 21, and introduction assistance is performed through the backflow prevention valve provided at the proximal end portion of the instrument body 15 of the introduction assisting instrument 11. The therapeutic instrument is inserted into the tubular body 13 of the instrument 11. Further, along the guide wire for the therapeutic instrument, the therapeutic instrument is pushed forward in the tubular body 13 of the introduction assisting instrument 11 and introduced into the side branch tubular organ through the side hole 27 to treat the lesion site.

FIG. 6 shows the rigid portion 25 ′ of the second embodiment of the introduction aid 11.
The rigid portion 25 ′ of the second embodiment is different from the slit 29 extending in the transverse direction in that a plurality of slits 33 extending in the longitudinal direction of the tubular body 13 are provided at both ends of the rigid portion 25 ′. The second embodiment is different from the rigid portion 25 of the first embodiment, and has the same configuration as the rigid portion 25 of the first embodiment in other points. Accordingly, here, a description will be given mainly of the configuration different from the rigid portion 25 of the first embodiment, and description of the common configuration will be omitted.

In the rigid portion 25 ′ of the second embodiment, in addition to the slit 29 extending in the transverse direction, a plurality of slits 33 extending in the longitudinal direction of the tubular body 13 are spaced apart from each other in the circumferential direction at both ends of the rigid portion 25 ′. Is formed. Further, each of both end portions of the rigid portion 25 ′ and the end portion of the main body portion 23 are connected and fixed in a state where one is inserted into the other. In the embodiment shown in FIG. Each end of 'is connected and fixed in a state of being inserted into the main body portion 23.

If both ends of the rigid portion 25 of the first embodiment and the end of the main body portion 23 are connected and fixed in a state where one is inserted into the other, the main body portion 23 suddenly moves to the rigid portion 25. Since the stiffness changes, when the tubular body 13 is bent, bending may occur at the boundary between the main body portion 23 and the rigid portion 25, and the main body portion 23 may be damaged. In contrast, in the rigid portion 25 ′ of the second embodiment, slits 33 extending in the longitudinal direction of the tubular body 13 are provided at both ends of the rigid portion 25 ′ connected to the flexible main body portion 23. Thus, the rigidity of both end portions of the rigid portion 25 ′ is reduced, and an intermediate rigid portion having intermediate rigidity between the main body portion 23 and the rigid portion 25 ′ is formed. As a result, when the tubular body 13 is bent, the intermediate rigid portion is deformed, and the occurrence of bending of the main body portion 23 is suppressed, and the damage to the main body portion 23 is reduced. As shown in FIG. 6, the slit 33 is preferably tapered toward the center in the longitudinal direction of the rigid portion 25 'so that the rigidity gradually changes in the intermediate rigid portion.

The slit 33 also has an effect of imparting flexibility to the rigid portion 25 ′ so that it can be flexibly deformed in accordance with the curvature of the introduction tubular conduit. Therefore, when the slit 33 is provided, it is possible to easily perform the operation of inserting the tubular body 13 into the introduction tubular organ without providing the transverse slit 29.

As mentioned above, although the introduction auxiliary instrument 11 with a side hole by this invention was demonstrated with reference to embodiment illustrated, this invention is not limited to embodiment shown in figure. For example, in the embodiment shown in FIG. 1, the rigid portion 25 has a substantially straight pipe shape, but the shape of the rigid portion 25 is not limited, as shown in FIG. It is also possible to form the tubular body 13 so as to have a curved shape in accordance with the shape of the distal end portion.

DESCRIPTION OF SYMBOLS 11 Introduction assistance instrument 13 Tubular body 21 Medical instrument 23 Main body part 25 Rigid part 27 Side hole 29 Slit 33 Slit

Claims

A tubular body to be inserted into a tubular organ of a human body is provided, a side hole is provided in a peripheral wall of the tubular body, and a medical device can be introduced into the tubular organ through the side hole of the tubular body An introduction aid,
The tubular body includes a flexible portion that can be bent, and a rigid portion that is provided at an intermediate portion of the flexible portion and has a rigidity higher than that of the flexible portion. An introduction assisting device with a side hole, wherein a slit is formed in the peripheral wall of the rigid portion so as to be imparted.
The introduction assisting device with a side hole according to claim 1, wherein the slit extends in a circumferential direction or an oblique direction with respect to the circumferential direction on the peripheral wall of the rigid portion.
The introduction aid with a side hole according to claim 2, wherein the slits are a plurality of slits formed at intervals in the direction of the longitudinal axis of the tubular body on the peripheral wall of the rigid portion.
The introduction assisting device with a side hole according to claim 3, wherein the plurality of slits are alternately provided on opposite sides of the peripheral wall of the rigid portion.
Each of the end portions of the rigid portion and the flexible portion are fixed in a state where one is inserted into the other, and a plurality of slits extending in the longitudinal direction of the tubular body are formed in the peripheral walls of the both end portions of the rigid portion. The introduction assisting device with a side hole according to claim 2, further formed at intervals in the circumferential direction.
The introduction assisting device with a side hole according to claim 5, wherein the plurality of slits extending in the longitudinal direction of the tubular body are tapered toward the center of the rigid portion.
Each of both ends of the rigid portion and the flexible portion are fixed in a state where one is inserted into the other, and the slit extends in the longitudinal direction of the tubular body at the peripheral walls of both ends of the rigid portion; The introduction assisting device with a side hole according to claim 1, which is a plurality of slits formed at intervals in the circumferential direction.
The introduction assisting device with a side hole according to claim 7, wherein the slit is tapered toward a central portion of the rigid portion.
The introduction auxiliary device with a side hole according to any one of claims 1 to 8, wherein the introduction auxiliary device with a side hole is a sheath introducer, a guiding catheter, or a catheter for stenosis penetration.