WO2016167002A1

WO2016167002A1 - Medical tubular body

Info

Publication number: WO2016167002A1
Application number: PCT/JP2016/051924
Authority: WO
Inventors: 学西尾
Original assignee: 株式会社カネカ
Priority date: 2015-04-17
Filing date: 2016-01-22
Publication date: 2016-10-20
Also published as: JPWO2016167002A1

Abstract

The purpose of the present invention is to provide a medical tubular body which incurs less stimulus to the inner wall of a blood vessel and the like while having a configuration in which the diameter thereof is expandable. This medical tubular body has a ring-like body (100) the diameter of which is expandable, wherein the ring-like body (100) has a circumferential direction and an axial direction, and includes a first member (1) formed in a segment thereof in the circumferential direction, and a second member (2) formed in a segment thereof in the circumferential direction, the first member (1) and the second member (2) being slidably engaged with each other in the circumferential direction.

Description

Medical tubular body

The present invention relates to a medical tubular body that can be expanded in diameter, and is used, for example, to treat a lesion where a blood vessel or other in-vivo lumen is narrowed or occluded. More specifically, the present invention relates to a medical tubular body typified by a stent placed in a lesioned part of a living body lumen, or a medical tubular body used for removing a thrombus generated in a lesioned part.

A medical tubular body typified by a stent is generally a medical instrument for treating various diseases caused by stenosis or occlusion of a blood vessel or other living body lumen. The medical tubular body has a lumen in the lesion such as a stenosis or occlusion that is expanded from the inside and is placed in the lesion to maintain the inner diameter of the lumen, or has occurred in or around the lesion. Examples include entanglement of a thrombus and the like to remove it from the body and recover the lumen inner diameter at the lesion.

The ring-shaped member (annular body) constituting the stent is configured so that the circumference thereof can be increased so that the diameter expansion operation of the stent can be performed. FIG. 10 is a perspective view showing the configuration of a conventional annular body 100 of a stent. As shown in FIG. 10, the ring-shaped body 100 has a narrow portion 101 on one end side, and the narrow portion 101 is led out from the inside to the outside through a hole 102 provided in a part of the ring-shaped body 100. Has been. When a balloon (not shown) arranged inside the ring-shaped body 100 is inflated, a stress acts from the inside to the outside of the ring-shaped body 100, and accordingly, the diameter of the ring-shaped body 100 is expanded, and the narrow portion 101. This is a mechanism in which the derivation length of s decreases gradually.

More specifically, for example, in Patent Document 1, a plurality of T-shaped unit portions including a head portion and an elongated body portion extending from the head portion are arranged side by side and are connected to each other at the head portion. A polymer stent that is integrally formed is described. In the polymer stent of Patent Document 1, each body portion is rounded and inserted into and locked in a slit formed in the head portion to form a ring shape, which becomes a tubular shape as a whole.

Also, Patent Document 2 describes a stent that has a plurality of ring-shaped component pieces, and each ring-shaped component piece is connected to each other with a connecting piece at a necessary interval. In the stent of Patent Document 2, each ring component piece is provided on one end side, and the other end side is provided on the other end side. The locking part that is passed to the outer surface side, the locking part side is passed through the insertion port so that the ring component piece becomes a ring shape, and the locking part is penetrated from the curved outer surface side to the inner surface side so that the locking part is In the locked state, the locking position is provided with a plurality of locking receiving portions that move only in one direction in which the diameter of the ring component piece expands.

JP 2011-251117 A Republished 2011-021654

In the conventional medical tubular body, as represented by the annular body 100 of the stent in FIG. 10, a part (the narrow portion 101 or the like) of the stent passes through the hole 102 provided in a part of the annular body 100. Since the structure protrudes outward, local stimulation is applied to the inner wall of the blood vessel, which may cause restenosis in the blood vessel.

For example, in the stent of Patent Document 1, a ridge-like protrusion is formed on the outer surface that comes into contact with a blood vessel, whereby stimulation is applied to the inner wall of the blood vessel, thereby causing restenosis. In Patent Document 2, a protrusion is formed in a ring-shaped portion passing through the insertion opening, which may cause restenosis.

An object of the present invention is to provide a medical tubular body that has a structure capable of expanding its diameter and has little irritation to an inner wall of a blood vessel or the like.

That is, the medical tubular body of the present invention that has solved the above-described problems is a medical tubular body having a ring-shaped body that can be expanded in diameter, and the ring-shaped body has a circumferential direction and an axial direction. It has the 1st member currently formed in the partial area, and the 2nd member formed in the partial area of the circumferential direction, The said 1st member and the said 2nd member slide mutually in the circumferential direction Engageable. In the present invention, while the ring-shaped body 100 has a configuration capable of expanding the diameter, the portion protruding outward from the ring-shaped body 100 is smaller than the conventional ring-shaped body 100 (FIG. 10) described above. There is little irritation to the inner wall of the lumen in the living body.

In the medical tubular body, the first member and the second member are slidable in a direction in which the circumference of the annular body increases, and are mutually in a direction in which the circumference of the annular body decreases. It is desirable not to slide.

In the medical tubular body, a convex portion is formed on a surface of the first member that faces the second member, and a concave portion is formed on the surface of the second member that faces the first member. It is desirable that at least one of the convex part or the concave part has an anisotropic shape in the circumferential direction.

In the medical tubular body, it is desirable that radiopaque markers are formed on the first member and the second member.

In the medical tubular body, it is desirable that the first member and the second member each include a stopper portion that contacts each other.

It is desirable that the medical tubular body has a plurality of the annular bodies.

In the medical tubular body, it is preferable that the plurality of annular bodies have different masses.

In the medical tubular body, it is preferable that the plurality of ring-shaped bodies are connected to each other through a support column.

In the above-described medical tubular body, it is desirable that a plurality of the support columns exist, and each support column is provided with a radiopaque marker, and the positions of the markers in the axial direction are different from each other.

In the medical tubular body, the annular body is meandering, and the width of the meandering is preferably reduced as the diameter of the annular body increases.

In the medical tubular body, in the state where the annular body is meandering, the first member and the second member are not affected even when a stress is applied from the radially inner side to the outer side of the annular body. It is desirable to have a sliding drag that does not slide in the circumferential direction.

In the medical tubular body, it is desirable that a width of the first member and a width of the second member in the axial direction of the annular body are different from each other.

In the above-described medical tubular body, an embodiment in which the first member and the second member are adjacent to each other in the axial direction can be preferably implemented.

In the above-described medical tubular body, an embodiment in which the first member and the second member are arranged more inside than the other can be preferably implemented.

In the medical tubular body, it is desirable that the annular body contains a biodegradable substance.

The medical tubular body of the present invention includes a ring-shaped body having a first member formed in a partial section in the circumferential direction and a second member formed in a partial section in the circumferential direction. And the second member are slidably engaged with each other in the circumferential direction, so that there are few members projecting outward from the ring-shaped body while having a configuration capable of expanding the diameter, so that the inner wall of a blood vessel or the like There is little irritation. Thus, the present invention can provide a medical tubular body that can reduce the probability of restenosis of a living body lumen.

1 is a perspective view of a ring-shaped body of a medical tubular body according to a first embodiment of the present invention. FIG. 2 is an enlarged exploded view of a portion A of the ring-shaped body of FIG. FIG. 3 is an enlarged view of a portion A of the ring-shaped body of FIG. 1 and shows a state where the first member and the second member are engaged. FIG. 4 is a diagram illustrating a state in which the first member and the second member of the annular body in FIG. 3 slide with each other. FIG. 5 is a perspective view of the first member and the second member of the ring-shaped body of FIG. 4 as viewed from the B direction. FIG. 6 is a perspective view of the medical tubular body according to the first embodiment of the present invention. FIG. 7 is a development view of the medical tubular body according to the second embodiment of the present invention. FIG. 8 is a perspective view of the medical tubular body according to the third embodiment of the present invention. FIG. 9 is a perspective view of a medical tubular body according to the fourth embodiment of the present invention. FIG. 10 is a perspective view of a conventional ring-shaped body.

Before describing in detail the medical tubular body according to the embodiment of the present invention, the general configuration of the medical tubular body will be described. In the present specification, a configuration in which a marker made of a radiopaque material is removed from a medical tubular body is referred to as a “tubular body”. The tubular body includes one or a plurality of ring-shaped bodies.

(1) Use of medical tubular body The medical tubular body is used in a living body lumen. For example, it is placed in a lesioned part of a living body lumen to maintain or expand the diameter of the living body lumen. For example, a thrombectomy device for removing a thrombus formed in a lumen in a living body, or a peripheral protection device (peripheral protection filter).

(2) Classification of medical tubular bodies For medical tubular bodies, for example, (i) a coiled type made of a single linear metal or polymer material, and (ii) a metal tube cut out with a laser or the like (Iii) a type in which linear portions are welded and assembled, and (iv) a type in which a plurality of linear metals are woven.

The medical tubular body is used by being attached to a catheter (delivery system: delivery device) or the like having a portion where the medical tubular body is placed for delivery (delivery) to a lesioned part. The classification from the viewpoint of the expansion mechanism of the medical tubular body includes (i) mounting (mounting) the medical tubular body on the outer surface of the balloon and transporting it to the lesioned area, It can be divided into a balloon expandable type that expands and a self-expandable type that expands by itself by removing the member that suppresses expansion at the lesioned part by transporting it to the lesioned part with a catheter having a member that suppresses expansion.

In a state where the medical tubular body is installed in a delivery system composed of a balloon, a catheter, or the like, the medical tubular body contracts in the direction perpendicular to the longitudinal axis of the tubular body (the radial direction of the tube) and extends in the longitudinal axis direction. By this, it becomes a cylindrical shape (reduced diameter state) which is longer than the expanded state. In the self-expanding type, since it is not necessary to provide a balloon inside, the diameter of the reduced diameter state can be reduced as compared with the balloon expansion type.

(3) Tubular body The tubular body is composed of, for example, a group of ring-shaped bodies, and the ring-shaped body is a structure that can be expanded in diameter and has a structure that extends the circumference of a band-shaped member. In the present invention, “expandable diameter” means that the tube can be extended in a direction (radial direction) perpendicular to the long axis of the tubular body. The tubular body may be contracted (reduced diameter) in reverse from the state in which the diameter is expanded, or may have a ratchet mechanism so that the diameter can be increased but not reduced. The tubular body is formed, for example, from a pattern of interconnected structural elements that expand and contract in the circumferential and axial directions. The tubular body in the present invention can be applied in any pattern and is therefore not limited to any particular stent shape or structural element pattern.

(4) Marker Once the medical tubular body is placed in the body, its position cannot be confirmed visually. Therefore, a marker including a radiopaque material is provided at a predetermined position of the medical tubular body so that the medical tubular body can be observed under fluoroscopy. The marker does not need to completely block X-rays, and may be any X-ray transmittance that can detect the presence of the marker under fluoroscopy.

(Embodiment 1)
Hereinafter, an annular body that is a component of the medical tubular body according to the first embodiment of the present invention will be described with reference to the drawings.

FIG. 1 is a perspective view of a ring-shaped body of a medical tubular body according to the first embodiment of the present invention. In FIG. 1, a ring-shaped body 100 has a circumferential direction and an axial direction, and a first member 1 formed in a partial section in the circumferential direction and a second member 2 formed in a partial section in the circumferential direction. And have. The partial section in the circumferential direction in which the first member 1 is formed has the meaning of excluding the entire circumference in the circumferential direction, but the place in the circumferential direction is not limited. Similarly, the second member 2 is also formed in a partial section in the circumferential direction, but the first member 1 and the second member 2 may be engaged with each other. It is not limited whether the two members 2 are formed in the same section as the first member 1 or are formed in a section different from the first member 1.

If the first member 1 and the second member 2 formed in this way are slid in the direction in which the overlapping portions of the first member 1 and the second member 2 decrease, the circumference of the annular body 100 increases, and as a result, the annular body 100 is expanded in diameter. The

As described above, the medical tubular body according to the first embodiment of the present invention has a configuration in which the first member 1 and the second member 2 slide, so that the configuration shown in FIG. Compared to the case, there are few portions projecting outward from the ring-shaped body 100, and therefore there is less stimulation to the inner wall of the body lumen such as blood vessels. Therefore, the probability that the in-vivo lumen is restenosis can be reduced.

The shape of the annular body 100 in the present invention is most typically a circular shape, but is not limited to a circular shape, and includes an elliptical shape and a rectangular frame shape. Sa) is not limited.

Since the medical tubular body according to the present embodiment has the gist that the circumference of the annular body can be extended by sliding the first member 1 and the second member 2 engaged with each other as described above, In addition to the first member 1 and the second member 2, for example, it may further include a third member (not shown) formed in a partial section in the circumferential direction and overlapping the second member 2 in the circumferential direction. Good. In this case, the second member 2 and the third member may be slidably engaged with each other in the circumferential direction, or the second member 2 and the third member may be fixed to each other without sliding. .

As shown in FIG. 1, the ring-shaped body 100 includes a plurality of first members 1 and a plurality of second members 2, and the first members 1 and the second members 2 are alternately arranged in the circumferential direction and in the axial direction. You may form by engaging alternately. By adopting such a configuration, the ring-shaped body 100 is formed in a narrow range in the axial direction, so that the shape of the ring-shaped body 100 is not easily distorted.

The structure and method of engagement between the first member 1 and the second member 2 are not particularly limited. Although details will be described later, for example, the first member 1 or the second member 2 may be provided with guide rails or grooves. The first member 1 and the second member 2 may be in line contact with each other in order to improve slippage, or may be in surface contact with each other in order to make slippage difficult.

The medical tubular body according to the present embodiment can preferably further include the following configuration. For example, the first member 1 and the second member 2 are configured to be slidable in the direction in which the circumference of the ring-shaped body 100 increases (that is, the diameter-enlarging direction of the ring-shaped body 100). It is also possible to adopt a configuration in which they do not slide with respect to each other in the direction in which the circumferential length decreases (that is, the diameter reduction direction of the annular body 100). For example, by providing the ring-shaped body 100 with a ratchet mechanism, it is possible to cause the medical tubular body to perform a stepwise and irreversible diameter expansion operation. That is, when the balloon disposed inside the medical tubular body is inflated, the diameter of the medical tubular body is expanded, but the medical tubular body is not reduced in diameter even if the stress by the balloon is removed. The state can be maintained.

As described above, in addition to employing the ratchet mechanism for the ring-shaped body 100, for example, by giving a constant static friction resistance between the first member 1 and the second member 2, similarly, the stress from the inside caused by the balloon Even if there is not, the medical tubular body is not reduced in diameter by static friction, and the expanded diameter can be maintained.

FIG. 2 is an enlarged exploded view of part A of the ring-shaped body of FIG. In order to provide the ring-shaped body 100 with a ratchet mechanism, the first member 1 is formed with a convex portion 3 on the surface facing the second member 2, and the second member 2 has the first member 1 with the first member 1. A concave portion 4 is formed on the opposing surface, and the positional relationship between the first member 1 and the second member 2 is fixed by fitting the convex portion 3 and the concave portion 4 together. And since at least one of the convex part 3 or the recessed part 4 has an anisotropic shape in the circumferential direction of the ring-shaped body 100, it is easy to slide in one direction of the circumferential direction, but difficult to slide in the other direction. Or it becomes a structure which cannot slide. Although not shown, the concave portion 4 may be formed on the first member 1 and the convex portion 3 may be formed on the second member 2. When the third member is used as described above, the second member 2 is engaged with the first member 1 and is engaged with the third member. 2, the convex portion 3 or the concave portion 4 may be formed on the side facing the first member 1, and the convex portion 3 or the concave portion 4 may be formed on the side facing the third member.

In order for the first member 1 and the second member 2 to slide smoothly, it is preferable to use an elastic material such as a resin as the material of the first member 1 and the second member 2. If the 1st member 1 and the 2nd member 2 are comprised with the resin material, since the convex part 3 will fall easily in the direction where stress is applied, it will become easy to slide the 1st member 1 and the 2nd member 2. FIG.

The material used for the first member 1 and the second member 2 is not particularly limited as long as it is a material that can withstand a strong load at the time of deformation or indwelling, such as expansion or contraction. 316L stainless steel, tantalum, Co—Cr (cobalt chromium) alloy, Ni—Ti (nickel-titanium) alloy, etc., which are medical stainless steels, can be preferably used. In particular, a nickel-titanium alloy can be preferably used because it has elastic characteristics and is excellent in workability. Of the nickel-titanium alloys, an alloy containing about 50% by mass to about 60% by mass of nickel can be preferably used.

On the other hand, since the medical tubular body is indwelled in the human body, the first member 1 and the second member 2 are viable when taking into account the deformation of blood vessels after surgery and patients with metal allergies. It is desirable to include a degradable material, such as a biodegradable polymer or metal. The biodegradable material may be a composite of at least two biodegradable polymers and / or metals. Examples of materials that can be used as biodegradable substances include polylactic acid, polycaprolactone, polyhydroxybutyrate, polyglycolic acid, silk elastin polymer, polyhydroxy acid copolymer, polyester, polysaccharide, and one of these. The composition containing the above is mentioned.

It is preferable that a plurality of convex portions 3 are provided for one first member 1. In addition, it is preferable that a plurality of recesses 4 are provided for one second member 2. The number of the convex portions 3 and the number of the concave portions 4 are not particularly limited, but the first member 1 and the second member 2 can be reduced by reducing the number of the convex portions 3 that are likely to have an acute angle structure to be smaller than the number of the concave portions 4. The convex part 3 is exposed in the section which is not engaged, and the state which can contact | abut to a living body lumen inner wall can be avoided. Further, the convex portion 3 is not disposed over the entire length direction of the first member 1 (the circumferential direction of the ring-shaped body 100), but is provided only in a partial section in the length direction of the first member 1. Even in such a configuration, it is possible to avoid a state in which the convex portion 3 is exposed and can come into contact with the inner wall of the living body lumen.

As shown in FIG. 2, it is desirable that the convex portion 3 is unevenly distributed inward in the radial direction of the first member 1. The outer side of the first member 1 in the radial direction is a portion that can come into contact with the inner wall of the in-vivo lumen, in order to reduce the influence of the complicated shape of the convex portion 3 on the in-vivo lumen. Similarly, it is desirable that the recess 4 is unevenly distributed inward in the radial direction of the second member 2. The outer side of the second member 2 in the radial direction is also a portion that can come into contact with the in-vivo lumen, in order to reduce the influence of the complicated shape of the recess 4 on the inner wall of the in-vivo lumen.

If the configuration in which the convex portion 3 is not in contact with the inner wall of the living body lumen is taken, even if the convex portion 3 is arranged over the entire length direction of the first member 1, the convex portion 3 is formed. Problems that may abut against the inner wall of the body lumen are likely to be solved. The same applies to the recess 4.

Preferably, as shown in FIG. 2, the first member 1 includes an upper stage 1 a that is in the axial direction (one side) of the annular body 100 and in the radial direction (inward) of the annular body 100, and the axial direction (other side) of the annular body 100. And the lower stage 1b in the radial direction (outward) of the ring-shaped body 100, and the convex part 3 on the upper stage 1a. Further, as shown in FIG. 2, the second member 2 includes a lower stage 2 b in the axial direction (one side) of the annular body 100 and in the radial direction (inward) of the annular body 100, and the axial direction (other side) of the annular body 100. And an upper stage 2a in the radial direction (outward) of the ring-shaped body 100, and a recess 4 in the lower stage 2b. By forming the 1st member 1 and the 2nd member 2 in this way, the problem that the convex part 3 or the recessed part 4 can contact | abut to the living body lumen inner wall in the outer side of the annular body 100 is easy to be solved.

In addition, it is desirable that the convex portion 3 is formed inside the first member 1 and is not exposed outwardly or inwardly in the radial direction of the first member 1. The same applies to the concave portion 4, and it is desirable that the concave portion 4 is formed inside the second member 2, and is not exposed outwardly or inwardly in the radial direction of the second member 2.

As shown in FIG. 2, a groove 5 extending in the circumferential direction of the ring-shaped body 100, that is, in the circumferential direction of the first member 1 is formed in the first member 1, while the groove 5 is formed in the second member 2. A protrusion-shaped guide portion 6 is formed to be fitted to. The first member 1 and the second member 2 are positioned so as not to be separated from each other by the fitting between the groove 5 and the guide portion 6. It is desirable that the guide portion 6 protrudes in a direction orthogonal to the protrusion direction of the convex portion 3. For example, as shown in FIG. 2, when the protruding direction of the convex portion 3 is the axial direction of the annular body 100, the guide portion 6 is preferably protruded in the radial direction of the annular body 100. Such a configuration, that is, a fitting direction of the convex portion 3 and the concave portion 4 (axial direction of the annular body 100) and a fitting direction of the groove 5 and the guide portion 6 (radial direction of the annular body 100) are different. By being (more preferably by being orthogonal), the engagement between the first member 1 and the second member 2 is ensured. In addition, the guide part 6 may extend in the circumferential direction of the second member 2 or may be provided only in a partial section of the second member 2.

FIG. 3 is an enlarged view of a portion A of the ring-shaped body of FIG. 1 and shows a state in which the first member 1 and the second member 2 are engaged. FIG. 4 is a diagram illustrating a state in which the first member 1 and the second member 2 of the annular body in FIG. 3 slide with each other. As shown in FIGS. 3 and 4, the convex portion 3 and the concave portion 4 preferably have an anisotropic shape in the circumferential direction. In this case, the first member 1 and the second member 2 slide in one direction. Easy, but difficult to slide in the reverse direction or cannot slide. For example, as shown in FIGS. 2 to 4, the convex portion 3 is inclined to one side in the circumferential direction, and the protrusion tip portion of the convex portion 3 is shifted to one side in the circumferential direction from the base portion of the convex portion 3. In position. Therefore, although the 1st member 1 is easy to slide to the other direction of the circumferential direction, it is hard to slide to the opposite one direction of the circumferential direction. When the convex part 3 is not inclined, it is desirable that the concave part 4 is inclined. Specifically, as shown in FIGS. 2 to 4, the bottom of the recess 4 (the location corresponding to the protrusion tip of the projection 3) is the opening of the recess 4 (the location corresponding to the base of the projection 3). Rather than one side in the circumferential direction. Of course, it is preferable that both the convex part 3 and the recessed part 4 have an anisotropic shape in the circumferential direction.

3 and 4, it is preferable that a radiopaque marker 7 is formed on the first member 1 and the second member 2. When the medical tubular body enters the body, the degree of diameter expansion of the annular body 100 cannot be quantitatively confirmed. Therefore, by forming a radiopaque marker 7 at a predetermined position of the first member 1 and the second member 2, the first member 1 and the second member 2 can be obtained from the relative positional relationship of the markers 7. The amount of diameter expansion of the ring-shaped body 100 can be grasped from the distance that the member 2 has slid and the distance. The marker 7 does not need to completely block X-rays, and may be any X-ray transmittance that can detect the presence of the marker under fluoroscopy.

FIG. 5 is a perspective view of the first member 1 and the second member 2 of the ring-shaped body of FIG. 4 viewed from the B direction. As shown in FIG. 5, it is preferable that a stopper portion 8 is formed on the first member 1 and a stopper portion 9 is formed on the second member 2. The first member 1 and the second member 2 slide with each other, and the first member 1 does not eventually come out of the second member 2, but the stopper portion 8 of the first member 1 and the second member 2. When the stopper portions 9 come into contact with each other, the sliding of the first member 1 and the second member 2 is completed. That is, the diameter expansion of the ring-shaped body 100 stops. The stopper portion 8 may be formed as a member different from the first member 1 or may be integrally formed with the first member 1. The same applies to the stopper portion 9, and it may be formed as a member different from the second member 2, or may be integrally formed with the second member 2.

FIG. 6 is a perspective view of the medical tubular body according to the first embodiment of the present invention. As shown in FIG. 6, the medical tubular body according to the present embodiment has a plurality of annular bodies 100 in the axial direction. This is because by forming a plurality of annular bodies 100, it is possible to set different diameter expansion amounts for each annular body 100 in accordance with the characteristics of the lesioned part of the lumen in the living body. In order to realize this, the balloon used for expanding the diameter of the medical tubular body can be constituted by a plurality of bag-like objects having different capacities.

Each ring-shaped body 100 may be the same (same mass), but when the ring-shaped body 100 contains a biodegradable substance, each ring-shaped body 100 may have a different mass. When each ring-shaped body 100 has the same mass, it is assumed that the time when each ring-shaped body 100 is completely disassembled is almost the same period, and the shape of the medical tubular body collapses at once. May affect the treatment of in vivo lumens. When each ring-shaped body 100 has a different mass, for example, the first member 1 and the second member 2 included in one ring-shaped body 100 and the first member 1 included in another ring-shaped body 100 are included. When the thickness of the second member 2 is different from that of the second member 2, it is possible to disperse the time when the ring-shaped body 100 collapses due to biodegradation, and to reduce the influence on the treatment of the in vivo lumen.

As shown in FIG. 6, it is preferable that the adjacent ring-shaped bodies 100 are connected to each other via the column 10. As shown in FIG. 6, the support column 10 may be connected between the first member 1 and the second member 2, or between the first members 1 or between the second members 2. It may be connected.

As shown in FIG. 6, the medical tubular body desirably has a radiopaque marker 11. This is for grasping the position of the medical tubular body in the body under fluoroscopy. By providing the marker 11 inside the support column 10 (inward in the radial direction of the ring-shaped body 100), the marker 11 does not protrude outward from the ring-shaped body 100, so that stimulation to the inner wall of the body lumen can be reduced. it can. Further, by designing the at least two markers 11 so that the positions in the axial direction when the diameter of the ring-shaped body 100 is reduced are different from each other, the markers 11 do not interfere with each other when the diameter of the ring-shaped body 100 is reduced. 100 can be reduced in diameter. Although there are various specific modes for forming the two markers 11 at different positions in the axial direction of the ring-shaped body, there is a method of varying the length of the column 10 as shown in FIG.

As a manufacturing method of the first member 1 and the second member 2 which are constituent elements of the ring-shaped body 100, an injection molding method, a laser processing method, a mechanical cutting process, etching, three-dimensional printing, and the like can be suitably used. .

The material constituting the marker 7 and the marker 11 is not particularly limited as long as the material has higher radiopacity than the constituent material of the annular body 100. In consideration of the influence on the living body, a metal material is preferable, and platinum, palladium, and tantalum are preferable in view of excellent biocompatibility particularly with respect to the human body. In particular, when a nickel-titanium alloy is used as the material of the marker housing, tantalum is preferred because it has a small difference in electrochemical potential and is difficult to corrode.

The size of the medical tubular body is not particularly limited. In the first embodiment, the outer diameter of the tubular body is, for example, about 0.36 to 0.46 mm when contracted, and about 4.0 to 4.5 mm when expanding, for example. It is.

(Embodiment 2)
Hereinafter, the medical tubular body according to the second embodiment of the present invention will be described with reference to the drawings. FIG. 7 is a development view of the medical tubular body according to the second embodiment of the present invention. In the medical tubular body according to the second embodiment of the present invention, the same members as those in the medical tubular body according to the first embodiment of the present invention are denoted by the same reference numerals, and description thereof is omitted.

Unlike the one according to the first embodiment, the annular body 100 of the medical tubular body according to the second embodiment of the present invention meanders. As shown in FIG. 7, the width of the meander (the axial length of the ring-shaped body 100) is W. In the medical tubular body according to the second embodiment, since the annular body 100 meanders, the balloon 100 disposed inside the annular body 100 expands to reduce the width W while the width W is reduced. The That is, the ring-shaped body 100 of the medical tubular body according to the second embodiment is (1) the diameter expansion due to the first member 1 and the second member 2 sliding relative to each other, like the ring-shaped body 100 of the first embodiment. (2) As described above, there are two types of diameter expansion mechanisms for expanding the diameter by reducing the meandering width W of the ring-shaped body 100. Thus, by having two types of diameter expansion mechanisms, the magnification (maximum diameter / minimum diameter) capable of diameter expansion can be increased. Even when the magnification capable of expanding the diameter is not increased, the diameter-enlarging ability of the ring-shaped body 100 is increased by the mechanism having meandering, so that the design freedom of the first member 1 and the second member 2 is increased.

In order to make the ring-shaped body 100 meander, for example, as shown in FIG. 7, there is a method of connecting the first member 1 and / or the second member 2 to a fourth member 12 having a bent shape. Thereby, even if the 1st member 1 and / or the 2nd member 2 are members of a linear shape, the ring-shaped body 100 can be made to meander shape. The fourth member 12 is preferably a plastic material. This is because the ring-shaped body 100 maintains the expanded diameter state even if the balloon or the like is removed after the diameter of the ring-shaped body 100 is increased by a balloon or the like. On the other hand, when a self-expanding medical tubular body is used, it is desirable to use an elastic material for the fourth member 12. This is because the elastic material has higher shape retention of the medical tubular body.

In the second embodiment, when the ring-shaped body 100 is meandering, the first member 1 and the second member 2 slide in the circumferential direction even when stress is applied from the inside to the outside of the ring-shaped body 100. It is desirable to have a sliding drag that does not occur. In other words, in a state where the ring-shaped body 100 is meandering, if a stress is applied to the ring-shaped body 100 from the inner side to the outer side in the radial direction of the ring-shaped body 100, the meandering width W is reduced, thereby reducing the circumference of the ring-shaped body 100. As the length increases, the ring-shaped body 100 has room to further expand its diameter, which means that the resistance of the first member 1 and the second member 2 to the slide is set higher than the stress in such a situation. If the ring-shaped body 100 is fully extended until the ring-shaped body 100 finally disappears, the diameter expansion due to the decrease in the meandering width W does not work, so the balloon 100 or the like moves from the radially inner side to the outer side. If a greater stress is applied, the first member 1 and the second member 2 begin to slide with each other in the same manner as the ring-shaped body 100 of the first embodiment, and the ring-shaped body 100 is further expanded in diameter.

Thus, in the state where the ring-shaped body 100 is meandering, the first member 1 and the second member 2 do not slide in the circumferential direction even when a stress is applied from the radially inner side to the outer side of the ring-shaped body 100. The structure of having a certain level of sliding drag is that the first member 1 and the second member 2 slide relative to each other in the direction in which the circumference of the ring-shaped body 100 increases, such as when the first member 1 and the second member 2 have a ratchet mechanism or a slide and lock mechanism. This is particularly effective when it has a configuration that does not slide in the direction in which the circumference of the ring-shaped body 100 decreases. That is, since the sliding amount of the first member 1 and the second member 2 is not restored, the amount of diameter expansion of the ring-shaped body 100 can be finely controlled. The ring-shaped body 100 is expanded in diameter by reducing the meandering width W in the first stage of diameter expansion, and is adjusted and expanded by sliding the first member 1 and the second member 2 in the second stage of diameter expansion. A diameter is made.

On the contrary, by setting the sliding drag between the first member 1 and the second member 2 low, the first member 1 and the second member 2 slide on each other in the first stage of diameter expansion. It is possible to increase the diameter by increasing the diameter and decreasing the meandering width W in a later stage of the expansion. In this case, the diameter expansion may end before the meandering width W becomes zero. However, the meandering ring-shaped body 100 has a merit that it can easily follow the movement of the lumen in the living body because of its high flexibility.

In this specification, “in the state where the ring-shaped body is meandering, even if a stress is applied from the inside to the outside of the ring-shaped body, the first member and the second member do not slide each other in the circumferential direction. "The state in which the ring-shaped body is meandering" in the definition of "having a ring" means a state in which the meandering width W (maximum width) of the ring-shaped body is larger than 1/10 of the maximum diameter R of the ring-shaped body. Shall mean. The “sliding drag” is the magnitude of the force required for the first member 1 and the second member 2 to start relative sliding from a stationary state. For example, in the case of the ratchet mechanism of FIG. If so, it is determined by the shape, number, rigidity, and the like of the convex portions 3 and the concave portions 4.

(Embodiment 3)
Hereinafter, the medical tubular body according to the third embodiment of the present invention will be described with reference to the drawings. FIG. 8 is a development view of the medical tubular body according to the third embodiment of the present invention. In the medical tubular body according to the third embodiment of the present invention, the same members as those in the medical tubular body according to the first embodiment of the present invention are denoted by the same reference numerals, and description thereof is omitted.

Unlike the one according to the first embodiment, the ring-shaped body 100 of the medical tubular body according to the third embodiment of the present invention has the width of the first member 1 and the width of the second member 2 in the axial direction of the ring-shaped body. Are different from each other. For example, as shown in FIG. 8, the second member 2 has a wider width than the first member 1. When the ring-shaped body 100 is composed of a wide member, the followability to bending and meandering of the blood vessel and the like is relatively lowered, but the contact area to the inner wall of the blood vessel and the like is widened because the second member 2 is wide. Large and less irritating. Therefore, the probability that the blood vessel or the like is restenosis is reduced.

(Embodiment 4)
Hereinafter, the medical tubular body according to the fourth embodiment of the present invention will be described with reference to the drawings. FIG. 9 is a development view of the medical tubular body according to the fourth embodiment of the present invention. In the medical tubular body according to the fourth embodiment of the present invention, the same members as those in the medical tubular body according to the first embodiment of the present invention are denoted by the same reference numerals, and description thereof is omitted.

In the annular body 100 of the medical tubular body according to the first embodiment, the first member 1 and the second member 2 are adjacent to each other in the axial direction, whereas the medical member according to the fourth embodiment. In the tubular ring-shaped body 100, the first member 1 is arranged on the inner side than the second member 2. In this way, by forming the other member inside the one member, the boundary portion between the two members (first member 1 and second member 2) that slide in opposite directions from each other hits the inner wall of a blood vessel or the like. You can avoid touching. Therefore, the probability that the blood vessel or the like is restenosis is reduced. Of course, even if it is the structure where the 2nd member 2 is distribute | arranged inside the 1st member 1, it can implement similarly.

This application claims the benefit of priority based on Japanese Patent Application No. 2015-85156 filed on April 17, 2015. The entire contents of the specification of Japanese Patent Application No. 2015-85156 filed on April 17, 2015 are incorporated herein by reference.

DESCRIPTION OF SYMBOLS 1 1st member 1a Upper stage 1b Lower stage 2 2nd member 2a Upper stage 2b Lower stage 3 Convex part 4 Concave part 5 Groove 6 Guide part 7 Marker 8 Stopper part 9 Stopper part 10 Strut 11 Marker 12 Fourth member 100 Ring-shaped body

Claims

A medical tubular body having a ring-shaped body capable of expanding the diameter,
The annular body has a circumferential direction and an axial direction, and has a first member formed in a partial section in the circumferential direction and a second member formed in a partial section in the circumferential direction. The medical tubular body, wherein the first member and the second member are slidably engaged with each other in the circumferential direction.
The said 1st member and the said 2nd member are mutually slidable in the direction where the circumferential length of the said annular body increases, and do not slide mutually in the direction where the circumferential length of the said annular body decreases. The medical tubular body.
The first member has a convex portion formed on a surface facing the second member,
The second member has a recess formed on the surface facing the first member,
The medical tubular body according to claim 2, wherein at least one of the convex portion or the concave portion has an anisotropic shape in a circumferential direction.
The medical tubular body according to any one of claims 1 to 3, wherein a radiopaque marker is formed on the first member and the second member.
The medical tubular body according to any one of claims 1 to 4, wherein each of the first member and the second member includes a stopper portion in contact with each other.
The medical tubular body according to any one of claims 1 to 5, which has a plurality of the annular bodies.
The medical tubular body according to claim 6, wherein the plurality of annular bodies have different masses.
The medical tubular body according to claim 6 or 7, wherein the plurality of ring-shaped bodies are connected to each other through a support column.
The medical tubular body according to claim 8, wherein a plurality of the support columns exist, and each support column is provided with a radiopaque marker, and the positions of the markers in the axial direction are different from each other.
The medical tubular body according to any one of claims 1 to 9, wherein the annular body is meandering, and the width of the meandering decreases as the diameter of the annular body increases.
In a state where the ring-shaped body is meandering, the first member and the second member do not slide in the circumferential direction even when a stress is applied from the inside to the outside in the radial direction of the ring-shaped body. The medical tubular body according to claim 10, which has a degree of sliding drag.
The medical tubular body according to any one of claims 1 to 11, wherein a width of the first member and a width of the second member in the axial direction of the annular body are different from each other.
The medical tubular body according to any one of claims 1 to 12, wherein the first member and the second member are adjacent to each other in the axial direction.
The medical tubular body according to any one of claims 1 to 13, wherein the first member and the second member are disposed more radially inward than the other in the radial direction of the annular body.
The medical tubular body according to any one of claims 1 to 14, wherein the annular body contains a biodegradable substance.