WO2013133081A1

WO2013133081A1 - Stent delivery system

Info

Publication number: WO2013133081A1
Application number: PCT/JP2013/054887
Authority: WO
Inventors: 泰誠川北; 秀昭山下; 知浩須藤
Original assignee: テルモ株式会社
Priority date: 2012-03-08
Filing date: 2013-02-26
Publication date: 2013-09-12

Abstract

A stent delivery system (1) comprises: a stent (3); a tube-shaped main body (2); a movable section (4) which includes a stent housing cylindrical member (5) which houses the stent; and a non-movable section (8) which is located further to the rear end side than the movable section (4) and partially encompasses the tube-shaped main body. The stent (3) is exposed by moving the movable section rearward with respect to the tube-shaped main body. The movable section has a sliding outer face, and the outer face of the non-movable section (8) has a higher sliding resistance than the outer face of the movable section (4).

Description

Stent delivery system

The present invention relates to a stent delivery system for placing a stent in a stenosis or occlusion formed in a living body such as a blood vessel, a bile duct, a trachea, an esophagus, a urethra, a digestive tract, or other organs.

Conventionally, a stent is placed in a stenosis or occlusion formed in a living body lumen or body cavity such as a blood vessel, bile duct, trachea, esophagus, urethra, gastrointestinal tract, or other organs to secure a lumen or body cavity space. A delivery system has been proposed.
The stent constituting the stent delivery system includes a balloon-expandable stent and a self-expandable stent depending on the function and the placement method.

The balloon-expandable stent does not have an expansion function, and in order to place the stent at the target site, for example, after inserting the stent mounted on the balloon into the target site, the balloon is expanded and the expansion force of the balloon is used. The stent is expanded (plastically deformed) and fixed in close contact with the inner surface of the target site.
This type of stent requires a stent expansion operation as described above.

On the other hand, the self-expanding stent has an expansion function. In order to place the stent at the target site, the stent is inserted into the target site in a contracted state, and then the stress applied to maintain the contracted state is removed. For example, the stent is contracted and accommodated in a sheath having an outer diameter smaller than the inner diameter of the target site, and after the distal end of the sheath reaches the target site, the stent is released from the sheath. When the released stent is released from the sheath, the stress load is released, and the stent is restored to its pre-shrinking shape and expanded. Thereby, it adheres and fixes to the inner surface of the target part.
Since this type of stent has an expansion force, the stent itself does not need to be expanded like a balloon-expandable stent, and there are few problems that the diameter gradually decreases due to blood pressure or the like and restenosis occurs.

However, self-expanding stents are generally said to be less likely to be placed accurately at the target site than balloon expandable stents. The reason for this is that, in the case of a balloon expandable stent, only the liquid is injected into the balloon after the stent is placed in the intended stenosis, so that the stent can move back and forth during the expansion of the stent. Absent. On the other hand, the structure of the delivery system for the self-expanding stent has a structure in which the stent is housed and restrained between the inner tube and the outer tube, and a locking portion for restricting the movement of the stent is provided on the rear end side of the inner tube. By pulling the tube toward the rear end, the stent is released and self-expanded. At this time, slack in the body cavity of the outer tube, friction between the outer tube and the catheter introducing the body cavity or the outer tube, friction with a valve of a device called an introducer for introducing the system into the body, etc. Because of this, it is said that the stent is easy to advance when it expands.

Therefore, the applicant of the present application has proposed the one shown in Patent Document 1 (US Publication 2010-076541, Japanese Unexamined Patent Publication No. 2008-272261).
The stent delivery system 1 includes a distal end tube 2 having a guide wire lumen 21, a rear end side tube 4, a rear end portion of the distal end side tube 2, and a distal end portion of the rear end side tube 4, and a guide wire. A fixed tube 8 having an opening 23 communicating with the lumen 21; a tubular member 5 for housing a stent that encapsulates the distal end side of the distal tube 2 and is slidable in the rear end direction of the distal tube 2; One end is fixed to the stent 3 stored in the storage tubular member 5 and the stent storage tubular member 5, and extends in the rear end side tube 4 and is pulled to the rear end side of the rear end side tube. Thus, a pulling wire 6 (6a, 6b) that constitutes a moving means for moving the stent housing tubular member 5 to the rear end side is provided. The distal tube 2 is located on the distal side, contacts the rear end of the stent 3 housed in the stent housing tubular member 5, and restricts movement of the stent 3 toward the rear end side of the stent 3. Part locking part 22. Furthermore, the stent delivery system 1 includes a slide tube 7 that is disposed so as to be close to the rear end of the stent-accommodating tubular member 5 and that can move to the rear end side by pulling the

pulling wires

6a and 6b. The fixed tube 8 can store the slide tube 7 moved to the rear end side.

US Publication 2010-076541 (Japanese Unexamined Patent Publication No. 2008-272261)

The stent delivery system disclosed in Patent Document 1 includes a stent-accommodating tubular member and a slide that are movable at the time of releasing the stent (at the time of releasing) at the distal end including the stent-accommodating tubular member that accommodates the stent. Both the tube and the fixed tube which is a non-movable part (non-movable part) are included. In other words, the appearance of the stent delivery system of Patent Document 1 changes due to the movement of the movable part including the stent-accommodating tubular member that accommodates the stent during the stent opening operation (discharging operation). It has both a part (appearance change part) and a part (appearance non-change part) where an external appearance does not change.
In addition, this type of stent delivery system is a stent delivery system using a hemostasis valve such as a hand or a Y connector on the proximal side from the insertion port of a sheath introducer, a guiding sheath or a guiding catheter during use, that is, a stent opening operation. The system is fixed, and thereby the displacement of the stent delivery system can be suppressed.
However, when the movable part of the stent delivery system is located on the proximal side from the insertion port of the sheath introducer, guiding sheath or guiding catheter, that is, outside the living body, it is necessary to fix the movable part. It is possible to restrain the movement of the tubular member for storing the stent, which is the movable part of the tube, and the stent and the distal tube may be displaced forward during the opening operation, shortening the stent, so it is fixed firmly by hand or a hemostasis valve. Can not do it.

On the other hand, when all the movable parts are inserted into the living body through an insertion port such as a guideline catheter and only the non-movable parts are located outside the living body, it is necessary to firmly fix the non-movable parts with a hand or a hemostasis valve so as not to move. .
Therefore, an object of the present invention is to use a self-expandable stent, and a stent including a movable part including a stent-containing cylindrical member in which the stent is stored in the distal end portion, and a non-movable part located on the rear end side of the movable part. It is a delivery system, and the movable part as a whole has good slidability, and the non-movable part has higher sliding resistance than the movable part, and is used in any part of the movable part and the non-movable part. The present invention provides a stent delivery system that has good operability (in other words, it is not necessary to change the degree of fixation between a movable part and a non-movable part) even if it is sometimes fixed firmly.

What achieves the above object is as follows.
A stent that is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into a living body, and is expandable outward when placed in the living body, a tubular body having a guide wire lumen, and a stent that houses the stent in a distal end portion A movable part including a cylindrical member for storage; a non-movable part located on the rear end side of the movable part and partially encapsulating the tubular main body; and the stent includes a distal end of the tubular main body The movable portion is arranged so as to cover the portion, and the movable portion moves toward the rear end side with respect to the tubular main body, so that the rear end portion enters the non-movable portion or the non-movable portion. A stent delivery system in which the stent is exposed from the stent-housing tubular member, and the movable part has a slidable outer surface, One, at least a portion of the outer surface of the non-movable section, from the outer surface of the movable portion, a stent delivery system that is assumed to have a high sliding resistance.

FIG. 1 is a partially omitted external view of a stent delivery system according to an embodiment of the present invention. FIG. 2 is an enlarged external view of the distal end portion of the stent delivery system of FIG. FIG. 3 is an enlarged cross-sectional view of the distal end portion of the stent delivery system of FIG. 4 is a cross-sectional view taken along line AA in FIG. FIG. 5 is an enlarged sectional view taken along line BB in FIG. 6 is an enlarged sectional view taken along the line CC of FIG. 7 is an enlarged cross-sectional view taken along the line DD of FIG. FIG. 8 is an enlarged cross-sectional view of the vicinity of the rear end portion of the stent housing tubular member and the distal end portion of the slide tube of the stent delivery system of FIG. FIG. 9 is an enlarged cross-sectional view of the vicinity of a rear end side portion of the non-movable portion (fixed tube) of the stent delivery system of FIG. FIG. 10 is an explanatory diagram for explaining the operation of the stent delivery system according to the embodiment of the present invention. FIG. 11 is an enlarged cross-sectional view of a distal end portion of a stent delivery system according to another embodiment of the present invention. FIG. 12 is an enlarged external view of a distal end portion of a stent delivery system according to another embodiment of the present invention. 13 is an enlarged cross-sectional view taken along the line EE of FIG. FIG. 14 is an external view of an example of a stent used in the stent delivery system of the present invention. FIG. 15 is an enlarged front view of the vicinity of the operation unit of the stent delivery system of the present invention. FIG. 16 is an enlarged rear view of the vicinity of the operation unit of the stent delivery system shown in FIG. FIG. 17 is an explanatory diagram for explaining the internal structure near the operation unit of the stent delivery system shown in FIG. 15. 18 is a right side view of only the operation unit of the stent delivery system shown in FIG. FIG. 19 is an explanatory diagram for explaining the internal structure of only the operation unit of the stent delivery system shown in FIG. 15. FIG. 20 is a partially omitted external view of a stent delivery system according to another embodiment of the present invention. FIG. 21 is an enlarged cross-sectional view of the distal end portion of the stent delivery system of FIG. 22 is an enlarged cross-sectional view of a rear end portion of the stent delivery system of FIG.

The stent delivery system of the present invention will be described using examples.
A stent delivery system (in other words, a living organ expansion device) 1 of the present invention is formed in a substantially cylindrical shape, compressed in the direction of the central axis when inserted into a living body, and expandable outward when placed in a living body, A tubular main body 2 having a guide wire lumen 21, a movable part 4 including a stent housing tubular member 5 in which the stent 3 is housed in the distal end, and a rear end side of the movable part 4. And a non-movable part 8 that is partially encapsulated. Furthermore, the stent delivery system 1 is arranged so that the stent 3 covers the distal end portion of the tubular main body 2 and moves the movable portion 4 to the rear end side with respect to the tubular main body 2. The rear end portion enters the non-movable portion 8 or encloses the outer surface of the non-movable portion 8, and the stent 3 is exposed from the stent housing tubular member 5. The movable part 4 has a slidable outer surface, and at least a part of the outer surface of the non-movable part 8 has a higher sliding resistance than the outer surface of the movable part 4.

In the

stent delivery systems

1, 40, and 100, the tubular main body 2 includes a distal end side tube 20 having a guide wire lumen 21 and a rear end side tube 30, and a non-movable part (in other words, a fixed tube). 8, the rear end portion of the distal end side tube 20 and the distal end portion of the rear end side tube 30 are fixed, and an opening 23 communicating with the guide wire lumen 21 is provided at the rear end portion. The

stent delivery system

1, 40, 100 includes a movable portion 4 including a stent housing tubular member 5 that encloses the distal end side of the distal tube 20 and is slidable in the rear end direction of the distal tube 20. And one end of the stent 3 housed in the stent-housing tubular member 5 and the movable part 4, and extending through the non-movable part 8 and the rear end side tube 30, and the non-movable part and the rear end side tube By pulling to the rear end side, a pulling member constituting the moving means for moving the movable part 4 including the stent-accommodating tubular member 5 to the rear end side, that is, the pulling wires 6 (6a, 6b) Prepare.

As shown in FIG. 1, the

stent delivery system

1, 40, 100 has a pulling member for winding the pulling wire 6 at the rear end and moving the stent housing tubular member 5 toward the rear end. A winding mechanism, that is, a pulling wire winding mechanism is provided. Further, the

stent delivery system

1, 40, 100 includes a tubular main body 2 having a distal end side tube 20 and a rear end side tube 30, a stent 3, a movable portion 4 (a tubular member 5 for storing a stent and a slide tube 7), traction. An operation unit 10 having a winding mechanism for the wire 6, the non-movable part (fixed tube) 8 and the pulling wire 6 is provided. The non-movable part (fixed tube) 8 includes an opening 23 that connects the distal end side tube 20 and the rear end side tube 30 forming the tubular main body 2 and communicates with the rear end portion of the distal end side tube 20. Yes.

In the

stent delivery systems

1 and 40, the movable part moves the movable part toward the rear end side with respect to the tubular main body, so that the rear end part enters the non-movable part. The movable part 8 has a color distinguishable from the movable part and the non-movable part 8 to the rear end side part 9 (specifically, the rear end side tube 30) from the front end part to the rear end part where the opening 23 is located. is doing.
In the

stent delivery systems

1 and 40, all outer surfaces of the non-movable part 8 have higher sliding resistance than the outer surface of the movable part 4.

In the stent delivery system 1 of this embodiment, the pulling wire 6 is wound around the rear end portion of the rear end side tube 30 to move the stent housing tubular member 5 to the rear end side. A take-off mechanism is provided.
The stent delivery system 1 according to this embodiment includes a distal tube 20, a stent 3, a rear tube 30, a movable part 4 (stent-containing tubular member 5 and slide tube 7), a puller wire 6, and a non-movable part (fixed). (Tube) 8 and an operation unit 10 having a winding mechanism for the pulling wire 6. The non-movable part (fixed tube) 8 includes an opening 23 that connects the distal end side tube 20 and the rear end side tube 30 and communicates with the rear end portion of the distal end side tube 20.

As shown in FIGS. 1 to 10, the distal end side tube 20 is a tube body having a guide wire lumen 21 penetrating from the distal end to the rear end, and a distal end portion is formed by a distal end member 25 fixed to the distal end. And a tip opening 25a is provided at the tip thereof. Note that the distal end portion may be formed integrally with the distal end side tube. And the front end side tube 20 is being fixed to the non-movable part (fixed tube) 8 in the rear-end part. The rear end of the distal tube 20 communicates with an opening 23 formed in the non-movable part (fixed tube) 8. Further, the rear end portion of the distal tube 20 is curved as shown in FIG. Further, as shown in FIGS. 1 and 4, the opening 23 is formed obliquely so as to be inclined toward the rear end side. This facilitates guide wire guidance.

The front end side tube 20 is a tube body having a guide wire lumen 21 penetrating from the front end to the rear end as shown in FIGS. The distal tube 20 has an outer diameter of 0.3 to 2.0 mm, preferably 0.5 to 1.5 mm, and an inner diameter of 0.2 to 1.5 mm, preferably 0.3 to 1.2 mm. The length is 20 to 600 mm, preferably 30 to 450 mm.

The distal end member 25 is located on the distal end side of the distal end of the stent-accommodating tubular member 5 and is formed in a tapered shape that gradually decreases in diameter toward the distal end as shown in FIGS. Preferably it is. By being formed in this way, the insertion into the narrowed portion is facilitated. Moreover, it is preferable that the distal end side tube 20 includes a stopper that is provided on the distal end side relative to the stent 3 and prevents movement of the stent housing tubular member 5 in the distal end direction. In this embodiment, the rear end of the distal end member 25 can be brought into contact with the distal end of the stent housing tubular member 5 and functions as the stopper.
The outer diameter of the most distal end portion of the tip member (tip portion) 25 is preferably 0.5 mm to 1.8 mm. Further, the outer diameter of the maximum diameter portion of the tip member (tip portion) 25 is preferably 0.8 to 4.0 mm. Further, the length of the tapered portion is preferably 2.0 to 20.0 mm.

Further, as shown in FIGS. 3 and 4, the distal tube 20 is provided at a position on the rear end side of a predetermined distance from the distal end of the distal tube 20 in order to restrict movement of the stent 3 to the rear end side. The stent rear end locking portion 22 is provided. The locking part 22 is preferably an annular protrusion. The distal end side of the stent rear end portion locking portion 22 is a stent housing portion. The outer diameter of the locking portion 22 is large enough to contact the rear end of the compressed stent 3. Even if the stent-accommodating tubular member 5 moves to the rear end side, the stent 3 maintains its position by the locking portion 22, and as a result, is released from the stent-accommodating tubular member 5. .

In the stent delivery system 1 of this embodiment, as shown in FIGS. 3 and 4, the distal tube 20 has a predetermined distance (approximately the axial length of the stent) from the distal end side of the stent rear end locking portion 22. A stent distal end locking portion 26 provided at a position is provided. As shown in FIGS. 3 and 4, the stent distal end portion locking portion 26 is located slightly on the rear end side from the distal end of the stent housing tubular member 5. The locking portion 26 is preferably an annular protrusion. The space between the stent front end locking portion 26 and the stent rear end locking portion 22 is a stent housing portion. The outer diameter of the locking portion 26 is large enough to contact the distal end of the compressed stent 3. In addition, the stent distal end locking portion 26 has a tapered surface whose rear end surface is reduced in diameter toward the rear end. Therefore, when the stent is released, the stent distal end locking portion 26 does not become an obstacle, and the stent delivery system 1 is recovered after the release of the stent 3 (specifically, into the guiding catheter or sheath). Storage) becomes easy.

The outer diameters of the stent rear end locking portion 22 and the stent front end locking portion 26 are preferably 0.8 to 4.0 mm. The stent rear end locking portion 22 and the stent front end locking portion 26 are preferably annular projections as shown in the figure, but may be any one that restricts the movement of the stent 3 and can be extruded. One or a plurality of protrusions may be provided integrally with the distal end side tube 20 or as a separate member. Further, the stent rear end portion locking portion 22 and the stent front end portion locking portion 26 may be formed of separate members made of an X-ray contrast material. Thereby, the position of the stent can be accurately grasped under X-ray imaging, and the procedure becomes easier. As the X-ray contrast material, for example, gold, platinum, platinum-iridium alloy, silver, stainless steel, platinum, or alloys thereof are suitable. The protrusion is formed by forming a wire with an X-ray contrast material and winding it around the outer surface of the distal tube, or forming a pipe with the X-ray contrast material and caulking or bonding to the outer surface of the distal tube. It is attached.

The material for forming the distal end tube is preferably a material having hardness and flexibility, such as polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK, and the like. Resins such as (polyetheretherketone) and polyimide can be suitably used. In particular, among the above resins, a resin having thermoplasticity is preferable. The outer surface of the distal tube may be coated with a material having biocompatibility, particularly antithrombotic properties. As the antithrombogenic material, for example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer) and the like can be preferably used.

Further, when the distal end portion is constituted by a member separate from the distal end side tube, it is preferable to use a material having flexibility as the distal end portion (tip end member) 25. For example, olefinic elastomer (eg, polyethylene elastomer, polypropylene elastomer), polyamide elastomer, styrenic elastomer (eg, styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), polyurethane, urethane Rubbers such as synthetic resin elastomers such as fluoroelastomers and fluororesin elastomers, synthetic rubbers such as urethane rubber, silicone rubber and butadiene rubber, and natural rubbers such as latex rubber are used.

In particular, in the stent delivery system 1 of this embodiment, the distal end side tube 20 and the distal end member 25 are formed as separate members, and the distal end side tube 20 has a stopper member 27 fixed to the distal end portion. . The stopper member 27 includes a cylindrical portion fixed to the distal end side tube 20 and a skirt portion that extends in a tapered shape from the cylindrical portion. The stopper member 27 is embedded in the tip member 25 to prevent the tip member 25 from being detached and moved to the tip side. The stopper member 27 is preferably formed of metal (for example, stainless steel).

As shown in FIGS. 1, 2, and 4, the rear end side tube 30 is a tube body that penetrates from the front end to the rear end, and includes an operation unit 10 that is fixed to the rear end. The distal end portion of the rear end side tube 30 is joined to the non-movable part (fixed tube) 8 by a fixing member 84. The rear end side tube 30 includes a pulling wire lumen through which the pulling wire 6 can be inserted.
The rear end side tube 30 has a length of 300 mm to 1500 mm, more preferably 1000 to 1300 mm, an outer diameter of 0.5 to 1.5 mm, preferably 0.6 to 1.3 mm, and an inner diameter of It is 0.3 to 1.4 mm, preferably 0.5 to 1.2 mm.
The distance of deviation between the central axis of the rear end side tube 30 and the central axis of the front end side tube 20 is preferably 0.1 to 2.0 mm, and particularly preferably 0.5 to 1.5 mm.

The material for forming the rear end side tube is preferably a material having hardness and flexibility, for example, polyolefins such as polyethylene and polypropylene, polyesters such as polyamide and polyethylene terephthalate, fluorine-based polymers such as ETFE, PEEK (polyetheretherketone), polyimide and the like can be preferably used. The outer surface of the rear end side tube may be coated with a resin having biocompatibility, particularly antithrombotic properties. As the antithrombogenic material, for example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer) or the like can be used. Further, as a material for forming the rear end side tube 30, a material having a relatively high rigidity, for example, a metal such as Ni—Ti, brass, stainless steel, and aluminum, or a resin having a relatively high rigidity, for example, polyimide, chloride, etc. Vinyl, polycarbonate, etc. can also be used.

In the stent delivery system 1 of this embodiment, the movable part 4 is moved to the rear end side together with the stent housing tubular member 5 by pulling the pulling wires 6 (6a, 6b) in addition to the stent housing tubular member 5. A moving slide tube 7 is provided. And the non-movable part 8 can accommodate the slide tube 7 from the rear end side.
The stent-housing tubular member 5 is a tubular body having a predetermined length as shown in FIGS. 1 to 4 and 8, and the front end and the rear end are open. The distal end opening functions as a discharge port of the stent 3 when the stent 3 is placed in a stenosis in the body cavity. As shown in FIG. 10, the stent 3 is released from the opening of the distal end, thereby releasing the stress load and expanding and restoring the shape before compression.
The length of the stent-housing tubular member 5 is preferably about 20 mm to 400 mm, and more preferably 30 mm to 300 mm. The outer diameter is preferably about 1.0 to 4.0 mm, particularly preferably 1.5 to 3.0 mm. The inner diameter is preferably about 1.0 to 2.5 mm. Moreover, it is preferable that the cylindrical member for stent accommodation has the transparency which can visually recognize the stent to accommodate.

The stent-accommodating tubular member 5 includes a tubular member body 51 having a small-diameter portion 51a provided at the rear end portion, and a tubular portion 52 provided so as to enclose the small-diameter portion 51a. I have. The rear end portion of the small diameter portion 51a protrudes from the cylindrical portion 52. And the front-end | tip part 69 (69a, 69b) of the pull wire 6 (6a, 6b) penetrate | invades in the space | gap formed between the small diameter part 51a and the cylindrical part 52, and with the fixing agent 53 with which the space | gap was filled, It is fixed to the stent-housing tubular member 5. The small-diameter portion 51a includes a tapered portion whose outer diameter is reduced toward the rear end side, and a short cylindrical portion extending from the tapered portion toward the rear end side. And the cylindrical part 52 is being fixed to the rear-end part of the cylindrical member main-body part 51 so that the small diameter part 51a of the cylindrical member main-body part 51 may be enclosed. And the small diameter part 51a of the cylindrical member main-body part 51 comprises the cyclic | annular protrusion part which protrudes inward and the rear-end direction of the cylindrical part 52. As shown in FIG. An annular gap is formed between the annular protrusion and the inner surface of the cylindrical portion 52. The void portion is filled with a fixing agent, and the cylindrical member main body 51 and the cylindrical portion 52 are integrated. Further, tip portions (fixed points) 69 (69a, 69b) of the pulling wires 6 (6a, 6b), which will be described later, are fixed to the cylindrical member 5 by a fixing agent. As the fixing agent, it is preferable to use an adhesive such as an epoxy resin, an ultraviolet curable resin, or a cyanoacrylate resin, but it may be heat fusion.

And in the cylindrical member 5 for stent accommodation used in this Example, the cylindrical member main-body part 51 (except small diameter part 51a) and the cylindrical part 52 have a substantially the same outer diameter. . The outer diameter of the stent housing portion of the tubular member main body 51 is preferably about 1.0 to 4.0 mm, and particularly preferably 1.5 to 3.0 mm. The length of the stent-housing tubular member 5 is preferably about 20 to 400 mm, particularly preferably 30 mm to 300 mm. The length of the cylindrical member body 51 is preferably about 10 to 200 mm, particularly preferably 15 mm to 150 mm, and the length of the cylindrical portion 52 is preferably about 10 to 200 mm, and particularly 15 mm to 150 mm. 150 mm is preferred.
In addition, as the cylindrical member 5 for stent accommodation, it is not limited to what consists of the cylindrical member main-body part 51 and the cylindrical part 52 which were mentioned above, The integral thing may be sufficient.

The slide tube 7 is disposed so that the tip thereof is close to the rear end of the stent-housing tubular member 5. The slide tube 7 can be stored in a non-movable part (fixed tube) 8 from the rear end side. The slide tube 7 may be one that can be fitted to the non-movable part (fixed tube) 8 from the rear end side. The slide tube 7 can move to the rear end side together with the stent housing tubular member 5 by pulling the pulling wire 6, and is not fixed to the stent housing tubular member 5. The slide tube may be formed integrally with the stent housing tubular member 5.
The stent delivery system 1 according to this embodiment includes a ring-shaped member 75 that is housed in the slide tube 7 in an unfixed state and moves together with the slide tube 7, and the pulling

wires

6 a and 6 b are connected to the ring-shaped member 75. It is fixed to the inner surface. The slide tube 7 includes a ring-shaped member holding portion that allows the ring-shaped member 75 to rotate and substantially prevents movement in the axial direction. Thus, since the ring-shaped member 75 is rotatable with respect to the slide tube 7, the ring-shaped member 75, the pulling wire fixing portion, and the pulling wire itself are also rotated with respect to the rotation of the slide tube 7. It becomes difficult to follow.

Specifically, as shown in FIGS. 2 to 6 and 8, the slide tube 7 includes a slide tube main body 71 and a distal end side member that is fixed to the distal end and has a larger outer diameter and inner diameter than the slide tube main body 71. I have. In this embodiment, the distal end side member of the slide tube 7 is, as shown in FIG. 8, a first cylindrical member 72 and a second cylinder having substantially the same outer diameter and inner diameter as the first cylindrical member 72. And an outer tube portion constituted by the cylindrical member 73, and a third cylindrical member 74 disposed in the rear end portion of the first cylindrical member 72 and the distal end portion of the second cylindrical member 73. The inner tube portion to be fixed, and the outer tube and the inner tube are fixed. In other words, the first cylindrical member 72, the second cylindrical member 73, and the fixing portion 76 that fixes the third cylindrical member 74 are fixed. I have. The rear end portion of the second cylindrical member 73 that is the outer tube is fixed to the distal end portion of the slide tube main body 71 by a fixing portion 77.

In addition, the distal end portion of the slide tube main body 71 penetrates into the rear end portion of the second cylindrical member 73 that is the outer tube, and at the same time as the rear end portion of the third cylindrical member 74 constituting the inner tube portion. Distanced apart. Accordingly, the ring-shaped member is held by the distal end portion of the slide tube main body 71, the inner surface of the second cylindrical member 73 which is the outer tube, and the rear end portion of the third cylindrical member 74 constituting the inner tube portion. An annular recess constituting the part is formed. And the ring-shaped member 75 is accommodated in this annular recessed part which is a ring-shaped member holding part. Since the ring-shaped member 75 is not fixed to any of the slide tube main body 71, the second cylindrical member 73, and the third cylindrical member 74, it can rotate. However, the movement in the axial direction in the slide tube 7 is impossible except for the clearance. As the ring-shaped member 75, a metal ring is suitable. And the pulling

wires

6a and 6b are being fixed to the inner surface of the ring-shaped member 75 by the fixing |

fixed part

75a and 75b, as shown in FIG. As a fixing method, welding, an adhesive, or the like is preferable. Since the pulling

wires

6 a and 6 b are fixed to the ring-shaped member 75, the ring-shaped member 75 is also pulled by pulling the pulling

wires

6 a and 6 b, and is pushed by the ring-shaped member 75 from the front end side. As a result, the slide tube 7 also moves to the rear end side of the stent delivery system 1.

In addition, the slide tube 7 has a distal end portion encapsulating a rear end portion of the small diameter portion 51 a of the stent housing tubular member 5. Moreover, the slide tube 7 and the cylindrical member 5 for accommodating a stent are not joined. In this embodiment, as shown in FIGS. 4 and 8, the distal end portion of the slide tube 7 is not joined and is not substantially in contact with the small-diameter portion of the tubular member 5 for accommodating a stent. The rear end portion of 51a is encapsulated. Specifically, the distal end portion of the first tubular member 72 constituting the outer tube portion encapsulates the rear end portion of the small diameter portion 51a of the stent housing tubular member 5 without substantially contacting the same. Yes.
Further, in this embodiment, the slide tube 7 includes a reinforcing layer 78 over the entire slide tube main body 71. By providing such a reinforcing layer, the kink resistance is improved and the slide of the slide tube 7 becomes good. The reinforcing layer is preferably a mesh-like reinforcing layer. The mesh-like reinforcing layer is formed of a metal wire such as stainless steel, elastic metal, superelastic alloy, shape memory alloy having a wire diameter of 0.01 to 0.2 mm, preferably 0.03 to 0.1 mm. Can do. The mesh-like reinforcing layer may be formed of synthetic fibers such as polyamide fibers, polyester fibers, and polypropylene fibers.

Stent-containing tubular member 5 (tubular member body 51, rear end tubular portion 52), slide tube 7 (slide tube body 71), non-movable part (fixed tube) 8 (front end non-movable part (front end) Side fixing tube) 81, rear end non-movable part (rear end fixing tube)) 82, for example, polyester such as polyethylene, polypropylene, polyamide, polyethylene terephthalate, fluorine, such as polyimide, PTFE, ETFE Polymers and further thermoplastic elastomers are preferred. The thermoplastic elastomer is suitably selected from polyamide elastomer (for example, polyamide elastomer), urethane (for example, polyurethane elastomer), polyester (for example, polyethylene terephthalate elastomer), and olefin (for example, polyethylene elastomer, polypropylene elastomer). Selected. Further, the stent-accommodating tubular member 5, the slide tube 7, and the non-movable portion 8 may be formed by a combination of the two-layered polymers described above (for example, polyamide elastomer on the outer surface and PTFE on the inner surface).

In the

stent delivery systems

1 and 40 of the present invention, the entire area of the movable portion 4 has a slidable outer surface, and the outer surface of the non-movable portion 8 has a higher sliding resistance than the outer surface of the movable portion 4. It has become.
Specifically, the outer surfaces of the stent-accommodating tubular member 5 and the slide tube 7 that are the entire area of the movable portion 4 are slidable outer surfaces. Therefore, it is possible to smoothly insert the

stent delivery systems

1 and 40 into the target site, and even after the mobile site 4 is firmly fixed by a hand or a hemostasis valve after the insertion into the target site, it is movable. The movement to the rear end side of the site, that is, the exposure operation of the stent can be performed well. The slidable outer surface is made of a slidable substance, particularly a hydrophilic substance that exhibits slidability (lubricity) only when wet (specifically, when it comes into contact with a liquid containing water such as blood). It is formed by coating. Examples of hydrophilic substances include polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate, carboxymethyl cellulose, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, polydimethylacrylamide, and dimethylacrylamide-glycidyl methacrylate. Examples thereof include a polymer and polyvinyl pyrrolidone. Among these, polydimethylacrylamide and dimethylacrylamide-glycidyl methacrylate copolymer are particularly preferable. Moreover, in order to make the slidability of the stent 3 favorable on the inner surface of the stent-accommodating tubular member 5, the above-described coating may be performed.

The hydrophilic substance as described above swells when it comes into contact with water, and when the swelled hydrophilic substance is present between certain objects, the frictional resistance between the two can be remarkably reduced and used as a lubricant. be able to. Derivatives obtained by condensation or addition reaction or substitution reaction of these hydrophilic substances, and those partially crosslinked are also effective as lubricants. These were supported on the base material by covalently bonding them with the reactive functional groups present or introduced in the material (base material) forming the movable member 4 or on the surface of the base material, or by crosslinking these themselves. A hydrophilic material layer (lubricating layer) can be obtained, and a continuous lubricating surface can be obtained without dissolving in water. The average molecular weight of these hydrophilic substances is not particularly limited, but is preferably about 10,000 to 5,000,000.
The reactive functional group present or introduced on the surface (outer surface) of the material for forming the movable part 4 is not particularly limited as long as it reacts with the hydrophilic substance and is bonded or cross-linked and fixed. However, diazonium group, azide group, isocyanate group, acid chloride group, acid anhydride group, imino carbonate group, amino group, carboxyl group, epoxy group, hydroxyl group, aldehyde group, etc. are conceivable, especially isocyanate group, amino group A group, an aldehyde group and an epoxy group are preferred. As the reactive functional group-containing substrate, modified polyolefin and the like are suitable. There are various bonding forms such as a covalent bond, an ionic bond, and a physical attachment, but the covalent bond is most preferable in view of the durability.

Examples of the substance having a reactive functional group introduced into the substrate include ethylene diisocyanate, hexamethylene diisocyanate, xylene diisocyanate, tolylene diisocyanate, diphenylmethane diisocyanate, naphthalene diisocyanate, diphenylmethane diisocyanate, phenylene diisocyanate, cyclohexylene diisocyanate, and tolphenyl. Polyisocyanates such as methane triisocyanate and tolylene triisocyanate, adducts or prepolymers of these polyisocyanates and polyols (for example, trimethylolpropane), and further, for example, ethylenediamine, trimethylenediamine, 1,2- Diaminopropane, tetramethylenediamine, 1,3-diaminobutane 2,3-diaminobutane, pentamethylenediamine, 2,4-diaminopentane, hexamethylenediamine, octamethylenediamine, nonamethylenediamine, decamethylenediamine, undecamethylenediamine, dedocamethylenediamine, tridecamethylenediamine, octa Decamethylenediacin, N, N-dimethylethylenediamine, N-diethyltrimethylenediamine, N, N-dimethyltrimethylenediamine, N, N-dibutyltrimethylenediamine, N, N, N'-triethylethylenediamine, N- Methyltrimethylenediamine, NN-dimethyl-p-phenylenediamine, N, N-dimethylhexamethylenediamine, diethylenetriamine, triethylenetetramine, tetraethylenepentamine, heptaethyleneoctamine, nonaethylenedecane, 1,3- Bi (2'-aminoethylamino) propane, bis (3-daminopropal) amine, N1,3-bis (3'-acinopropylamino) propane, 1,2,3-triaminopropane, tris (2-aminoethyl) Amine, tetra (aminomethyl) methane, methyliminobispropylamine, methyliminobisethylamine, ethyliminobisethylamine, N-aminopropyl-2-morpholine, N-aminopropyl-2-pipecoline, N- (2-hydroxyethyl) Trimethylenediamine, xylylenediamine, phenylenediamine, piperazine, N-methylpiperazine, N- (2-aminoethyl) ethanolamine, N-aminoethylpiperazine, N, N, N'N'-tetramethylethylenediamine, N, N, N'N'-tetramethyltetramethylenediamine Poly (alkylene polyamine) synthesized from [I] amine and alkylene dihalide or epichlorohydrin as a polymer polyamine [Encyclopedia of Polymer Science and Technology], Volume 10 , 616], [II] alkyleneimine polymers obtained by ring-opening polymerization of alkyleneimines such as ethyleneimine and propyleneimine [Ensauclopidia of Polymer Science and Technology, Volume 1, pages 734] , [III] Other polyamines such as polyvinylamine and polylysine, and further glutaraldehyde, terephthalaldehyde, isophthalaldehyde, dialdehyde, starch, galioxal, malonaldehyde, succinic acid aldehyde, Polyaldehydes such as dipaldehyde, pimelindialdehyde, suberindialdehyde, maleinaldehyde, 2-pentene-1,5-dialdehyde, ethylene glycol diglycidyl ether, polyethylene glycol diglycidyl ether, propylene glycol diglycinyl ether, polypropylene There are polyepoxides such as diglycidyl ether, hexanediol diglycidyl ether, and trimethylol propane triglycidyl ether. Of these, 4,4′-diphenylmethane diisocyanate, adduct (adduct) of tolylene diisocyanate and trimethylolpropane, adduct of hexamethylene diisocyanate and trimethylolpropane, or a trimer thereof, diethylenetriamine are most preferable.

Formation of the lubricating layer on the outer surface of the movable part 4 can be performed as follows, for example.
When a normal material that does not contain a reactive functional group is used as a material for forming the movable portion 4, first, an underlayer is formed. In order to form the underlayer, the movable part forming member is brought into contact (immersion, coating) in a solution containing the above-described substance having a reactive functional group, and then dried. Examples of the solvent used in the solution include ketones such as methyl ethyl ketone, methyl isobutyl ketone, and cyclohexanone, esters such as butyl acetate, ethyl acetate, carbitol acetate, and butyl carbitol acetate, methyl cellosolve, ethyl cellosolve, and tetrahydrofuran. Ethers, aromatics such as toluene and xylene, alkyl halides such as dichloroethane, alcohols such as methyl alcohol, and the like are used. The solvent is preferably a solvent that dissolves or swells the movable part forming material. This is because the adhesion strength of the underlayer is improved and the sustaining effect is further increased. As such a solvent, methyl ethyl ketone, cyclohexanone, tetrahydrofuran, xylene, methyl alcohol and the like are particularly suitable.

Next, the movable part shape member on which the base layer is formed is treated with the solution containing the hydrophilic substance of the present invention. The solvent used for the solution is preferably a solvent that does not react with the reactive functional group of the underlayer. Specifically, methyl ethyl ketone, tetrahydrofuran, acetone and the like are preferable. Moreover, what has the swelling property with respect to each member formation material is suitable. This treatment is preferably performed by dipping treatment, but may be performed by coating. In this way, a lubricating layer in which the hydrophilic substance is covalently bonded to the reactive functional group is formed on the surface of the movable part forming member.

The outer surface of the non-movable part 8 has a higher sliding resistance than the outer surface of the movable part 4.
In the stent delivery system 1 of this embodiment, the non-movable part (fixed tube) 8 is a tip-side non-movable part (tip-side fixed tube) having a large outer diameter, as shown in FIGS. 2 to 4, 7 and 9. ) 81 and a rear end non-movable portion (rear end side fixed tube) 82 fixed to the rear end portion of the front end non-movable portion (front end side fixed tube) 81. The distal-side non-movable part (front-end-side fixed tube) 81 includes a distal-end diameter-reduced portion 81a, and the inner surface of the distal-end diameter-reduced portion 81a is in contact with the outer surface of the rear end portion of the slide tube 7. The slide tube 7 is not fixed to the front end side non-movable part (front end side fixed tube) 81, and slides to the rear end side so that the slide tube 7 enters the front end side non-movable part (front end side fixed tube) 81. Enter and be stored.
As in this embodiment, the slide tube 7 is preferably of a type that is slidably accommodated in a non-movable part (fixed tube) 8, but the present invention is not limited to this, and the slide tube 7 The non-movable part (fixed tube) may be of a type fitted by a slide tube by sliding to the side.

The distal end portion of the rear end non-movable portion (rear end side fixed tube) 82 enters the rear end of the front end non-movable portion (front end side fixed tube) 81 and is fixed by the fixing portion 81b. Further, on the outer surface of the distal tube 20, there is a rear end portion of the non-movable part (fixed tube) 8, specifically, as shown in FIG. The slide tube locking part 24 is provided at the position. The slide tube 7 is slidable to the rear end side until it comes into contact with the slide tube locking portion 24. In other words, the slide tube 7 is restricted from moving further to the rear end side by contacting the slide tube locking portion 24.
Further, in this embodiment, as shown in FIGS. 3 to 4 and FIG. 9, the distal end portion of the non-movable portion (fixed tube) 8, specifically, the distal-side non-movable portion (tip-side fixed tube) 81. Is provided with a reinforcing layer 85 over substantially the whole. As the reinforcing layer, a mesh-like one, a spiral one, or the like is preferable. In particular, a mesh reinforcing layer is preferable. As the mesh-like reinforcing layer, those formed in a mesh shape with fine metal wires are suitable. As the metal thin wire, stainless steel is preferable. Further, as shown in FIG. 9, it is preferable that a reinforcing layer does not exist in a portion that becomes a connection portion with the rear end side non-movable portion (rear end side fixed tube) 82.
A cylindrical fixing member 83 that houses the rear end portion is provided at the rear end portion of the distal end side tube 20, and a cylindrical fixing member 84 is provided at the distal end of the rear end side tube 30. . As shown in FIGS. 7 and 9, a cylindrical fixing member 83 and a cylindrical fixing member 84 are fixed to a rear end non-movable part (rear end fixing tube) 82.

In the stent delivery system 1 of this embodiment, the entire non-movable portion 8 has a higher sliding resistance than the outer surface of the movable portion 4. In order to make the outer surface of the non-movable part 8 have high sliding resistance, for example, the non-movable part 8 is not coated with the hydrophilic substance coated on the movable part 4, and the forming material itself of the non-movable part 8 is the outer surface. Further, it can be formed by performing a sliding resistance improving process on the outer surface of the non-movable part 8.
The sliding resistance improvement process is performed after the outer surface of the non-movable part 8 is coated with a hydrophilic substance similar to that of the movable part 4.
The sliding resistance improvement process is performed by performing a non-lubricating process on the outer surface of the non-movable part 8. As the non-lubricating treatment, a treatment using an isocyanate compound is suitable. The isocyanate compound is considered to be non-lubricated by grafting to a hydrophilic substance or partially crosslinking it. Examples of such isocyanate compounds include ethylene diisocyanate, hexamethylene diisocyanate, xylene diisocyanate, tolylene diisocyanate, diphenylmethane diisocyanate, naphthalene diisocyanate, diphenylmethane diisocyanate, phenylene diisocyanate, cyclohexylene diisocyanate, triphenylmethane triisocyanate, and tolylene triisocyanate. Such polyisocyanates or monoisocyanates, or adducts or prepolymers of these polyisocyanates and polyols are used.
The non-lubricating treatment can be performed by bringing the outer surface of the non-movable portion 8 coated with a hydrophilic substance into contact (immersion, application) with a solution containing an isocyanate compound and then drying. Examples of the solvent used in the solution include ketones such as methyl ethyl ketone, methyl isobutyl ketone, and cyclohexanone, esters such as butyl acetate, ethyl acetate, carbitol acetate, and butyl carbitol acetate, methyl cellosolve, ethyl cellosolve, and tetrahydrofuran. Ether type, aromatic type such as toluene and xylene, and halogenated alkyl type such as dichloroethane are used.

In the stent delivery system 1 of this embodiment, the non-movable portion 8 is a color that can be distinguished from the movable portion 4 and the rear end side portion 9 from the non-movable portion 8 from the front end portion to the rear end portion where the opening 23 is located. have. For this reason, a movable part and a non-movable part can be recognized reliably and easily at the time of stent opening operation. Furthermore, since the guide wire port opening 23 is located at the rear end of the non-movable part 8 having an identifiable color, it is easy to recognize the position of the opening 23.
As described above, the stent delivery system 1 of this embodiment includes the stent-accommodating tubular member 5 and the slide tube 7, and the movable portion 4 is formed by both of them. Further, as described above, in the stent delivery system 1 of this embodiment, the non-movable part 8 includes the tip-side non-movable part (tip-side fixed tube) 81 and the tip-side non-movable part (tip-side fixed tube) 81. The rear end side non-movable part (rear end side fixed tube) 82 fixed to the rear end part is provided. Further, the rear end side portion 9, which is the rear end side from the non-movable portion 8, is configured by a rear end side tube 30 extending from the rear end portion of the non-movable portion (fixed tube) 8.
The outer surface of the rear end side tube 30 extending from the rear end portion of the non-movable part (fixed tube) 8 also has a higher sliding resistance than the outer surface of the movable part 4. In order to make the outer surface of the rear end side portion 9 (rear end side tube 30) have a high sliding resistance, for example, the rear end side portion 9 (rear end side tube 30) is coated with the hydrophilic portion 4 on the hydrophilic portion. The material is not coated, and the forming material itself of the rear end side portion 9 (rear end side tube 30) is to form the outer surface, and the outer surface of the rear end side portion 9 (rear end side tube 30) is It can form by performing a sliding resistance improvement process. The sliding resistance improving process is as described above.

Further, in the

stent delivery systems

1 and 40 of this embodiment, the movable part 4 moves the movable part 4 to the rear end side with respect to the tubular body 2 so that the rear end part enters the non-movable part 8. It is the type to do. As shown in FIG. 2, the non-movable part 8 has a color that can be distinguished from the movable part 4 from the front end to the rear end.
The non-movable part 8, specifically, the front end side non-movable part (front end side fixed tube) 81 and the rear end side non-movable part (rear end side fixed tube) 82 are colored, and the movable part 4 and the non-movable part are non-movable. It can be distinguished from the rear end side portion 9 with respect to the portion 8.
The color of the non-movable part 8 (the front-end side non-movable part 81 and the rear-end side non-movable part 82) may be any color, but since it is inserted into a living body such as a blood vessel, other than red The color is preferred. Specifically, green, yellow, blue, black and white are preferable. Moreover, although the front end side non-movable part 81 and the rear end side non-movable part 82 are the same color in what is shown in the drawing, they may be colored in different colors. Further, the non-movable part 8 (the front end side non-movable part 81, the rear end side non-movable part 82) is formed in a single color, but is not limited thereto.
Further, coloring of the non-movable part 8 (front end side non-movable part 81, rear end side non-movable part 82) can be performed, for example, by adding a colorant to the forming material of the non-movable part. In addition, dyes and pigments used as colorants include Bengala and Stronel Green as inorganic pigments, quinacridone, perylene, anthraquinone, and carbon black as organic pigments, and perylene and perinone as dyes. , Anthraquinone type, and heterocyclic type. Moreover, you may form the coloring of a non-movable part by laminating | stacking a colored layer on the resin base material layer of a non-movable part. The colored layer can be formed by adding the above-described colorant to a resin material having adhesiveness and a material for forming the non-movable part.

As shown in FIGS. 2 and 3, the stent delivery system 1 includes a plurality (specifically, two) of pulling

wires

6a and 6b, and the pulling

wires

6a and 6b are the above-described cylinders. The fixing points 69 a and 69 b are fixed to the outside of the small-diameter portion of the stent-housing tubular member 5 by the fixing agent 53 in the space provided in the cylindrical member 5. The pulling

wires

6a and 6b and the fixing

points

69a and 69b are separated by a predetermined length.
Then, the stent delivery system 1 has one end fixed to the rear end of the stent-accommodating tubular member 5, beyond the rear end of the stent-accommodating tubular member 5, and a slide tube 7, a non-movable part (fixed tube). A pulling wire 6 that extends through the rear end side tube 30 is provided. Then, by pulling the pulling wire 6 to the rear end side of the rear end side tube, the stent housing tubular member 5 and the slide tube 7 move to the rear end side.
As shown in FIG. 1 to FIG. 3, FIG. 5 to FIG. 8 and FIG. 10, this stent delivery system 1 includes a plurality of (specifically, two) pulling

wires

6a and 6b. The

wires

6a and 6b are fixed to the rear end portion of the stent-accommodating tubular member 5 by fixing

points

69a and 69b that are provided at portions that are considerably close to the stent. The pulling

wires

6a and 6b and the fixing

points

69a and 69b are arranged so as to be separated from each other by a predetermined distance.

Furthermore, in this embodiment, the pulling

wires

6a and 6b are fixed to members that move by pulling. Specifically, it is also fixed to a ring-shaped member 75 (specifically, the inner surface thereof) included in the slide tube 7 shown in FIG. For this reason, in the stent delivery system 1 of this embodiment, when the pulling

wires

6a and 6b are pulled toward the rear end side, the ring-shaped member 75 is also pulled toward the rear end side, and the slide tube is moved to the ring-shaped member 75. When 7 (slide tube main body 71) contacts, the slide tube is also pulled to the rear end side. Therefore, in this embodiment, the stent-accommodating tubular member 5 and the slide tube 7 are pulled separately from each other. It does not come into contact. Further, since the pulling force of the pulling

wires

6a and 6b is distributed to the fixing

points

69a and 69b and the fixing

portions

75a and 75b of the ring-shaped member 75 which is a member that moves by towing, the force at the fixing

points

69a and 69b. The release between the pulling

wires

6a, 6b and the stent housing tubular member 5 is reliably prevented.

In the stent delivery system 1 of this embodiment, as shown in FIG. 1, the puller wire 6 penetrates the rear end side tube 30 and extends from the rear end of the rear end side tube.
As a constituent material of the pulling wire, a single wire or a twist of a plurality of wires can be suitably used. The wire diameter of the pulling wire is not particularly limited, but is usually preferably about 0.01 to 0.55 mm, more preferably about 0.1 to 0.3 mm.
Further, as the forming material of the pulling wire 6, stainless steel wire (preferably, high-strength stainless steel for spring), piano wire (preferably, nickel-plated or chrome-plated piano wire), superelastic alloy wire, Wires made of various metals such as Ni-Ti alloy, Cu-Zn alloy, Ni-Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum, polyamide, polyimide, ultra high molecular weight polyethylene, polypropylene And a relatively high-rigidity polymer material such as a fluorine-based resin, or a combination of these appropriately.
Moreover, you may coat | cover the low-friction resin which increases lubricity on the outer surface of a pull wire. Examples of the low friction resin include fluorine resin, nylon 66, polyether ether ketone, and high density polyethylene. Among these, a fluorine resin is more preferable. Examples of the fluorine resin include polytetrafluoroethylene, polyvinylidene fluoride, ethylenetetrafluoroethylene, perfluoroalkoxy resin, and the like. Also, coating with silicon or various hydrophilic materials may be used.

Furthermore, in the stent delivery system 1 of this embodiment, a rigidity imparting body 11 is provided separately from the above-described pulling wire. As shown in FIGS. 1 to 4, 7, and 9, the rigidity imparting body 11 extends from the rear end side of the stent delivery system 1, passes through the rear end side tube 30, and further, a non-movable part (fixed tube). ) 8 is invaded. And the front-end | tip 11a of the rigidity provision body 11 is being fixed to the slide tube latching | locking part 24, as shown in FIG. At this time, it is preferable to fix the tip 11 a of the rigidity imparting body 11 by embedding it in the forming material of the slide tube locking portion 24. As shown in FIG. 3, the pulling

wires

6 a and 6 b are not fixed to the slide tube locking portion 24 and pass through

passages

24 a and 24 b formed in the slide tube locking portion 24.

Furthermore, in the stent delivery system 1 of this embodiment, as shown in FIG. 9, the rigidity imparting body 11 is also fixed to a cylindrical fixing member 84 fixed to a non-movable part (fixed tube) 8. As shown in FIG. 9, the cylindrical fixing member 84 is formed with a rigidity imparting body fixing portion 84 a that extends a predetermined length in the axial direction. Thus, the strong reinforcement effect by the front-end | tip part of the rigidity imparting body 11 is exhibited by fixing the front-end | tip part of the rigidity imparting body 11 in two places. In particular, the slide tube locking portion 24 is reinforced when the slide tube 7 contacts the slide tube locking portion 24.
And it is preferable that the rigidity provision body 11 is being fixed to the rear-end part of the rear-end side tube 30, or the operation part 10 mentioned later in the rear-end part. By providing such a rigidity imparting body 11, it is possible to suppress deformation of the stent delivery system when the traction member (traction wire) is pulled. Further, the tip 11a of the rigidity imparting body 11 may be formed to be a flat portion in order to ensure the fixation by the slide tube locking portion 24. Further, a wave-like portion may be formed on the side surface to provide a stopper from the slide tube locking portion 24.

As the rigidity imparting body 11, a single wire or a twist of a plurality of wires can be suitably used. The wire diameter of the rigidity imparting body 11 is not particularly limited, but is usually preferably about 0.01 to 1.5 mm, and more preferably about 0.1 to 1.0 mm.
Further, as the rigidity imparting body 11, the main body side portion (specifically, the portion in the rear end side tube) has high rigidity (for example, the wire diameter is thick), and the front end side portion has low rigidity (for example, It is preferable that the wire diameter is thin. Furthermore, it is preferable that the change point between the two is a tapered portion in which the wire diameter is deformed into a tapered shape.
Further, as a material for forming the rigidity imparting body 11, stainless steel wire (preferably, high-strength stainless steel for spring), piano wire (preferably, nickel-plated or chrome-plated piano wire), superelastic alloy wire. , Ni—Ti alloys, Cu—Zn alloys, Ni—Al alloys, tungsten, tungsten alloys, titanium, titanium alloys, cobalt alloys, and tantalum. Moreover, it is preferable that the rigidity imparting body 11 is harder than the pulling member (pulling wire).

The stent 3 is housed in the stent housing tubular member 5.
The stent 3 may be any so-called self-expanding stent. For example, as the stent 3, one having a shape as shown in FIG. 14 (showing a state expanded and restored to a shape before compression) can be suitably used. The stent 3 of this example has a cylindrical frame body 31, an opening 34 partitioned (bent) by

frames

36 a and 36 b constituting the cylindrical frame body 31, and a notch 35 partitioned by the frame 36 a. The frame body 31 has both

end portions

33a and 33b.

Since the stent 3 has the cutout portion 35 at the end of the frame body 31, the

end portions

33a and 33b of the stent 3 can be easily deformed. In particular, the end portions can be partially deformed, and the indwelling blood vessel is deformed. Good response to time. Moreover, since the edge part 33 is formed of the edge part of the some flame | frame 36a, it is hard to be crushed and has sufficient intensity | strength. Further, an opening 34 partitioned (enclosed) by the

frames

36a and 36b is formed between both ends, and the opening 34 is easily deformed by deformation of the frame 36a. For this reason, the deformation | transformation in the center part (center part of the frame 31) of the stent 3 is also easy. The notches and openings are not limited to the shape and number shown in the figure, and 3 to 10 notches are preferable and about 3 to 10 openings are suitable.
The frame body 31 has an outer diameter of 2.0 to 30 mm, preferably 2.5 to 20 mm, an inner diameter of 1.4 to 29 mm, preferably 1.6 to 28 mm, and a length of 10 to 150 mm. More preferably, the thickness is 15 to 100 mm.

The shape of the stent is not limited to that shown in FIG. For example, a trapezoidal cutout is formed at both ends and a plurality of hexagonal openings are formed in a honeycomb shape at the center, and a rectangular cutout is formed at both ends. The part may have a plurality of rectangular openings (having twice the length of the notch). Furthermore, the shape of the stent 3 is not limited to the above-described shape as long as it can be reduced in diameter when inserted into a living body and can be expanded (restored) when released into the living body. For example, a coil shape, a cylindrical shape, a roll shape, a deformed tubular shape, a higher order coil shape, a leaf spring coil shape, a cage or a mesh shape may be used.

A superelastic alloy is preferably used as a material for forming the stent. The superelastic alloy here is generally called a shape memory alloy, and exhibits superelasticity at least at a living body temperature (around 37 ° C.). Preferably, a Ti—Ni alloy of 49 to 53 atomic% Ni, a Cu—Zn alloy of 38.5 to 41.5 wt% Zn, a Cu—Zn—X alloy of 1 to 10 wt% X (X = Be, Si , Sn, Al, Ga), and a superelastic alloy such as a Ni-Al alloy of 36 to 38 atomic% Al is used. Particularly preferred is the Ti—Ni alloy described above. Further, a Ti—Ni—X alloy (X = Co, Fe, Mn, Cr, V, Al, Nb, W, B, etc.) in which a part of Ti—Ni alloy is substituted with 0.01 to 10.0 wt% X Or a Ti—Ni—X alloy (X = Cu, Pb, Zr) in which a part of the Ti—Ni alloy is substituted with 0.01 to 30.0% atoms, or cold working By selecting the rate or / and the final heat treatment conditions, the mechanical properties can be varied as appropriate. Further, the mechanical characteristics can be appropriately changed by selecting the cold work rate and / or the final heat treatment conditions using the Ti—Ni—X alloy.

The buckling strength (yield stress during loading) of the superelastic alloy used is 5 to 200 kgf / mm ² (22 ° C.), more preferably 8 to 150 kgf / mm ^2. Restoring stress (yield stress during unloading) ) Is 3 to 180 kgf / mm ² (22 ° C.), more preferably 5 to 130 kgf / mm ² . Superelasticity here means that even if it is deformed (bending, pulling, compressing) to a region where normal metal is plastically deformed at the operating temperature, it will recover to its almost uncompressed shape without the need for heating after the deformation is released. It means to do.
Such a stent is prepared, for example, by preparing a superelastic alloy pipe having an outer diameter suitable for an in-vivo site to be placed, and cutting the side surface of the superelastic alloy pipe (for example, mechanical cutting, laser cutting), It is produced by partially removing by chemical etching or the like and forming a plurality of notches or a plurality of openings on the side surface.
The stent used in the stent delivery system of the present invention includes a stent body having a substantially cylindrical shape that can be reduced in diameter and a cylindrical cover (not shown) that seals the side surface of the stent body. May be.

The stent delivery system of the present invention is not limited to the above-described embodiments. For example, a stent delivery system 40 shown in FIG. 11 may be used.
In the stent delivery system 40 of this embodiment, the non-movable portion (fixed tube) 8 includes a front-end-side non-movable portion (front-end-side fixed tube) 81 and a rear-end-side non-movable portion (like the stent delivery system 1 described above). The rear end side fixed tube) 82 is not provided, but a non-movable part (fixed tube) 28 formed integrally is provided. As shown in FIG. 11, the non-movable part (fixed tube) 28 includes a reinforcing layer 85 extending from the distal end side to the vicinity of the arrangement of the slide tube locking part 24. The reinforcing layer is the same as described above.
Also in this embodiment, the movable part 4 has the slidable outer surface as described above, and all the outer surfaces of the integrally formed non-movable part (fixed tube) 28 are more than the outer surface of the movable part 4. It has a high sliding resistance. In addition, the outer surface of the rear end side tube 30 extending from the rear end portion of the non-movable part (fixed tube) 28 has a higher sliding resistance than the outer surface of the movable part 4.

Further, in all the embodiments described above, the stent delivery system 100 shown in FIGS. 12 and 13 may be used.
In the stent delivery system of the above-described embodiment, the movable portion 4 is of a type in which the rear end portion enters the non-movable portion 8 by moving the movable portion 4 to the rear end side with respect to the tubular body 2. It has become. On the other hand, in the stent delivery system 100 of this embodiment, the non-movable part (fixed tube) 8 is a type in which the slide tube 7 is accommodated from the rear end side during pulling, in other words, the slide tube of the slide tube 7. The main body 71b is of a type that encapsulates the non-movable part (fixed tube) 8 from the rear end.
Further, in the stent delivery system 100 of this embodiment, the movable portion 4 includes the slide tube 7 arranged so as to be close to the rear end of the stent housing tubular member 5 in addition to the stent housing tubular member 5. The slide tube 7 can be fitted from the rear end side, and the slide tube 7 can be moved to the rear end side together with the stent housing tubular member by pulling the pull wire. Yes.

And also in this Example, the movable part 4 has a slidable outer surface as described above. Further, the outer surface of the non-movable part (fixed tube) 8 may have a higher sliding resistance than the outer surface of the movable part 4, but in this embodiment, as shown in FIG. The non-movable part 8 is a part that is encapsulated when the movable part 4 is moved, specifically, the entire front end-side non-movable part (tip-side fixed tube) 81 or the whole excluding the rear end part is a slidable outer surface. It may be. As the slidable outer surface, the same ones as described above are suitable. The rear end side non-movable portion 82 has a higher sliding resistance than the outer surface of the movable portion 4. In addition, the rear end portion of the distal-side non-movable portion (tip-side fixed tube) 81 may have a higher sliding resistance than the outer surface of the movable portion 4. In order to make the outer surface have a high sliding resistance, for example, the hydrophilic material coated on the movable part 4 is not coated, and the forming material itself of the non-movable part 8 forms the outer surface. It can form by performing a sliding resistance improvement process. The sliding resistance improving process is as described above.

Further, in the stent delivery system 100 of this embodiment, as shown in FIG. 12, the non-movable part 8 is a part that is not encapsulated even if the movable part 4 is movable (a part where the slide tube 7 is not fitted, the appearance is not changed). Part) Part to be encapsulated by the movement of the movable part 4 of the movable part 4 and the non-movable part 8 from the front end part of the part 8a to the rear end part having the opening 23 (part where the slide tube 7 is fitted, appearance change part) 8b and the non-movable part 8 have a color distinguishable from the rear end side part 9. For this reason, the appearance change site (4, 8b) and the appearance non-change site 8a can be recognized reliably and easily during the stent opening operation, and the guide wire port opening 23 provided in the appearance non-change site 8a is recognized. Is easy, and the stent placement operation can be performed well.
In the stent delivery system 100 of this embodiment, the slide tube 7 moves so as to be fitted to the distal end portion of the non-movable portion 8 (specifically, the distal-side non-movable portion (tip-side fixed tube) 81). Therefore, this portion becomes an appearance change portion 8b whose appearance changes when the movable portion 4 is moved. Moreover, since the external appearance of the stent-accommodating tubular member 5 and the slide tube 7 changes due to movement, they are the appearance change portions. Therefore, in the stent delivery system 100 of this embodiment, only the rear end side portion (specifically, the rear end non-movable portion 82) of the non-movable portion 8 which is the appearance non-change portion 8a is the movable portion 4 (stent The housing cylindrical member 5 and the slide tube 7), the distal end side fixed tube 81 of the non-movable part 8 and the rear end side part 9 from the non-movable part 8 have colors that can be distinguished.
The color of the non-movable part 8 appearance non-changeable part 8a (rear end side non-movable part 82) may be any color, but it is inserted into a living body such as a blood vessel. A color is preferred. Specifically, green, yellow, blue, black and white are preferable.
In the stent delivery system 100 of this embodiment, the inner diameter of the slide tube main body 71b is substantially equal to or slightly larger than the outer diameter of the distal-side non-movable part (tip-side fixed tube) 81 of the non-movable part (fixed tube) 8. It has become a thing. The distal-side non-movable part (front-end side fixed tube) 81 is fixed to the distal end part of the rear-end side non-movable part (rear-end side fixed tube) 82 at the rear end part by a fixing part. In this embodiment, the member 24 does not function as a slide tube locking portion.

And the stent delivery system 1 of this invention is provided with the operation part 10 fixed to the rear end of the rear end side tube 30, as shown in FIG. 1, FIG. 15 thru | or FIG.
FIG. 15 is an enlarged front view of the vicinity of the operation unit of the stent delivery system of the present invention. FIG. 16 is an enlarged rear view of the vicinity of the operation unit of the stent delivery system shown in FIG. FIG. 17 is an explanatory diagram for explaining the internal structure near the operation unit of the stent delivery system shown in FIG. 15. 18 is a right side view of only the operation unit of the stent delivery system shown in FIG. FIG. 19 is an explanatory diagram for explaining the internal structure of only the operation unit of the stent delivery system shown in FIG. 15.
In addition to the pulling wire winding mechanism, the operation unit 10 in the stent delivery system 1 of this embodiment includes a lock mechanism that releasably locks the rotation of the pulling wire winding mechanism, and winding of the pulling wire of the pulling wire winding mechanism. A reverse rotation restricting mechanism for restricting rotation in the direction opposite to the direction is provided.

The operation unit 10 includes an operation unit housing 50 as shown in FIGS. The operation unit housing 50 includes a first housing 50a and a second housing 50b. The operation portion housing 50 has a shape in which the rear end side and the central portion are bent and rounded, so that it is easy to grip, and the operation of the roller in the gripped state is easy.
And as shown in FIG. 17, the front-end | tip part of the cylindrical connector 45 is being fixed to the rear end of the rear end side tube 30. As shown in FIG. Further, a seal mechanism connected to the rear end portion of the connector 45 is accommodated in the operation portion housing 50. As shown in FIG. 17, the seal mechanism includes a seal mechanism tubular main body member 70 having a front end portion fixed to the rear end portion of the connector 45, and a cap member 70a fixed to the rear end of the tubular main body member 70. A sealing member 70b disposed between the cylindrical main body member 70 and the cap member 70a, and a rigidity imparting body fixing member 70c accommodated in the cylindrical main body member. The main body member 70 and the cap member 70a include an opening that penetrates. The seal member 70b includes a hole or a slit for allowing the pulling wire 6 (6a, 6b) to pass through in a liquid-tight state and slidable. Further, the rear end portion of the rigidity imparting body 11 is fixed to the rigidity imparting body fixing member 70c. The rigidity imparting body fixing member 70 c is fixed in the cylindrical main body member 70.

As shown in FIGS. 15 to 18, the housing 50 includes an opening 58 for partially projecting the operation rotary roller 61, and a locking rib that engages with a projecting portion of the gear portion 62 provided on the roller 61. (Not shown), a bearing portion 94b that houses one end 64b of the rotating shaft of the roller 61 and a bearing portion 94a that houses the other end 64a of the rotating shaft of the roller 61 are provided. The locking rib has a shape capable of entering between protrusions formed on the gear portion 62 of the roller 61. Further, as shown in FIGS. 15 and 16, the bearing

portions

94 a and 94 b are bowl-shaped members that house one end 64 b and the other end 64 a of the rotating shaft of the roller 61 and extend in a direction away from the above-described opening. It has become. The bearing

portions

94a and 94b are not limited to a hook shape, and may be any one that can move by a distance that allows the engagement with the locking rib to be released. For example, the shape of the bearing

portions

94a and 94b may be an ellipse, a rectangle, an ellipse, or the like. In particular, in the operation unit 10 of this embodiment, the

bearings

94a and 94b are bowl-shaped as shown in FIGS. For this reason, the operation rotating roller 61 is pushed, and the

end portions

64a and 64b of the rotating shaft of the roller 61 housed in the one end side space of the bearing

portions

94a and 94b are formed on the inner side surfaces of the central portions of the bearing

portions

94a and 94b. By overcoming the opposite rib portions, the

end portions

64a and 64b of the rotating shaft of the roller 61 are housed in the other end side space of the bearing

portions

94a and 94b. The state shown in FIG. 17 is a state where the roller 61 is pressed. In this state, the roller 61 is pressed by the urging member, but the

end portions

64a and 64b of the rotating shaft of the roller 61 abut against the opposing rib portions formed on the inner side surfaces of the central portions of the bearing

portions

94a and 94b. Since it contacts, it does not move to the one end side space of the bearing

portions

94a and 94b. For this reason, the roller 61 maintains a rotatable state.

In this embodiment, as shown in FIGS. 16 and 19, the operation unit 10 includes a collar member 12. The collar member 12 has a collar portion 14 that houses the winding shaft portion 63 and forms an annular space between the winding shaft portion 63. The collar portion 14 prevents the pulling wire wound around the winding shaft portion 63 from loosening. The collar member 12 also has a function of suppressing movement of the rotating roller when it is pressed and suppressing rattling of the rotating roller. The pin 13 of the collar member 12 is pivotally supported by the protruding portion (bearing portion) 59 of the first housing 50a and the concave portion (bearing portion) 158 of the second housing 50b. As shown in FIGS. 15 and 16, the bearing

portions

59 and 158 are formed in a gentle arc shape centering on the pin 13 (bearing portions 59 and 158), and the roller 61 is used for locking. It has a length that can move a distance greater than the height of the rib. Further, as shown in FIG. 19, the collar member 12 includes two notch portions 15 that face each other and reach the space in the collar portion 14 from the side surface. The pulling wire 6 passes through one of the cutout portions 15 and is fixed to the winding shaft portion 63.

The pulling wire winding mechanism includes a roller 61 and a winding shaft portion 63 that is rotated by the rotation of the roller 61. The winding shaft portion 63 holds or fixes the rear end portion of the pulling wire 6. Specifically, as shown in FIG. 16, the rear end portion of the pulling wire 6 includes an anchor portion 65 formed larger than the wire 6, and the winding shaft portion 63 stores the pulling wire 6. A possible slit 63a is provided. The rear end portion of the pulling wire 6 is accommodated in the slit 63a of the winding shaft portion 63 so that the anchor portion 65 is located outside the rear end of the slit 63a. Thereby, the winding shaft part 63 rotates, whereby the wire 6 is wound around the outer surface of the winding shaft part 63. The gripping or fixing of the pulling wire 6 to the winding shaft portion 63 is not limited to the above-described one, and any method may be used. For example, the rear end or rear end of the pulling wire 6 may be directly fixed to the winding shaft.

In addition, it is preferable that the rear end portion around which the pulling wire 6 is wound is flexible in order to facilitate winding. Such a flexible method can be performed by a method in which the rear end portion of the pulling wire 6 is formed of a flexible material, a method in which the rear end portion of the pulling wire 6 has a small diameter, or the like.
In this embodiment, the winding shaft portion 63 is integrated with the rotating roller 61 so as to be coaxial. Furthermore, as shown in FIG. 19, the winding shaft portion 63 is provided on one side of the rotating roller 61. Then, by rotating the rotating roller 61, the winding shaft portion 63 also rotates at the same time. And it is preferable that the winding amount of a pulling wire is small compared with the rotation operation amount of a rotating roller. By doing so, the winding can be performed slowly, and the movement of the stent housing tubular member toward the rear end side is also slow and good. In this embodiment, since the outer diameter of the winding shaft portion is smaller than that of the rotation operation roller, the winding amount of the pulling wire is smaller than the rotation operation amount of the rotation roller.

Further, the outer diameter of the winding shaft portion 63 is preferably about 1 to 60 mm, and particularly preferably 3 to 30 mm. The outer diameter of the rotating roller is 1 to 20 times the outer diameter of the winding shaft portion. The degree is preferable, and 1 to 10 times is particularly preferable. The outer diameter of the rotating roller is preferably about 10 to 60 mm, and particularly preferably 15 to 50 mm.
Note that the rotating roller and the winding shaft portion are not limited to such an integral one, and may be configured by separate members that rotate following the rotation of the rotating roller. . As a transmission method of the rotation of the rotating roller, any type such as a gear type or a belt type may be used. Moreover, it is preferable that the surface part which may be contacted when operating the roller 61 is a non-slip surface. For example, it is preferable to perform a knurling process, an embossing process, a high friction material coating, or the like on a surface part that may come into contact when the roller 61 is operated.

The operation unit 10 according to this embodiment includes a lock mechanism that locks the rotation of the pulling wire winding mechanism so as to be releasable, and a reverse rotation that restricts rotation of the pulling wire winding mechanism in a direction opposite to the winding direction of the pulling wire. A regulation mechanism is provided.
As shown in FIGS. 17 and 19, the operation rotation roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Further, as shown in FIG. 19, the gear portion 62 is provided on the other side surface side of the rotating roller 61 (in other words, the surface opposite to the surface on which the winding shaft portion 63 is provided). Therefore, the gear portion 62 and the winding shaft portion 63 are in a state of being partitioned by the wall formed by the operation roller portion.
Further, the operation rotating roller 61 is partially exposed from the opening, and this portion becomes an operation portion. The rotating roller is provided on the other end 64a of the rotating shaft provided on one side surface (specifically, the side surface of the gear portion) and on the other side surface (specifically, the side surface of the winding shaft). One end 64b of the rotating shaft is provided.

Further, the housing 50 is provided with an urging means (urging member) 80 for urging the rotating roller 61 toward the opening of the housing. Specifically, the roller 61 is urged by the urging means 80. Further, the housing 50 is provided with a locking rib (not shown) that can enter between the protrusions of the gear portion 62 of the rotating roller 61 urged by the urging member 80. For this reason, when the rotating roller 61 is urged by the urging member 80, the rotating roller 61 is in the state shown in FIG. 15, and the locking rib engages with the protruding portion of the gear portion 62, so that it cannot rotate. When the rotary roller 61 is pushed away from the locking rib, one end 64b and the other end 64a of the rotary shaft of the rotary roller can move and rotate in

bearings

94a and 94b provided in the housing 50. . Therefore, the operation unit 10 of this embodiment regulates the rotation in a state where the rotating roller 61 is not pressed, and has a lock mechanism that locks the rotation of the pulling wire winding mechanism so as to be releasable.

Further, in the operation portion of this embodiment, there is a reverse rotation restricting mechanism for restricting rotation of the pulling wire winding mechanism in the direction opposite to the winding direction of the pulling wire winding mechanism by the biasing means 80 and the gear portion 62 described above. It is configured.
As shown in FIGS. 15 to 17, the operation unit 10 includes a reverse rotation restricting mechanism. In the operation unit 10, the urging member 80 is provided with a reverse rotation restricting mechanism, and the urging member 80 is also a reverse rotation restricting member. The reverse rotation restricting mechanism is provided at a portion of the tip of the reverse rotation restricting member (which is also an urging member) 80 facing the gear portion 62 of the operation rotating roller 61, and a meshing portion 88 that can mesh with the gear portion, An elastically deformable portion 86 and a mounting portion 87 for housing are provided. The first housing 50 a includes a first protrusion (bearing part) 59 and a second protrusion 79 formed on the inner surface. The first projecting portion 59 enters the elastically deformable portion 86 of the reverse rotation restricting member (biasing member) 80 and has an outer surface shape corresponding to the inner surface shape of the elastically deformable portion 86. . Specifically, the inner surface shape of the elastically deformable portion 86 is an arc shape, and the first projecting portion 59 is a cylindrical shape corresponding to the arc shape. The mounting portion 87 of the reverse rotation restricting member (biasing member) 80 has a shape that can be mounted between the first projecting portion 59 and the second projecting portion 79 formed in the first housing 50a. The reverse rotation restricting member (biasing member) 80 becomes non-rotatable when the mounting portion 87 is mounted between the first projecting portion 59 and the second projecting portion 79 of the first housing 50a. At the same time, the operating rotary roller 61 is urged toward the opening 58 by the elastic force of the elastically deformable portion 86. Further, the mounting portion 87 of the reverse rotation restricting member (biasing member) 80 is restricted from moving in the side surface direction by a disk-like protruding portion 13 a provided on the collar member 12.

As described above, pressing the roller 61 allows the roller to rotate. However, rotation in the direction of the arrow in FIG. 17 (direction in which the pulling wire is wound) is possible. However, when the roller 61 is rotated in the reverse direction, one tooth portion of the gear portion 62 and the reverse rotation restricting member ( Engagement portion 88 of urging member 80 is engaged to prevent its rotation. This restricts the rotation of the roller in the direction opposite to the winding direction of the pulling wire of the pulling wire winding mechanism. In the operation unit 10, as shown in FIG. 18, the reverse rotation restricting member (biasing member) 80 is disposed between the inner surface of the first housing 50 a and the side surface of the rotating roller 61. For this reason, the movement of the reverse rotation restricting member (biasing member) 80 in the lateral direction (horizontal direction) is restricted by the inner surface of the first housing 50 a and the side surface of the rotating roller 61.
The gear portion 62 has a smaller diameter than the rotating roller. The outer diameter of the gear portion 62 is preferably about 10 to 60 mm, particularly preferably 15 to 50 mm, and the number of teeth is 4 to 200. The degree is suitable, and 4 to 70 is particularly preferred.
The collar member 12 included in the operation unit 10 has one end portion pivotally supported by the pin 13, and the collar portion 14 on the other end side accommodates the take-up shaft portion 63 and the take-up shaft portion 63. An annular space is formed between the two. This annular space is not a very large space, but forms a narrow annular space between the outer surfaces of the wound wire.

Next, the usage method of the stent delivery system 1 of this invention is demonstrated using drawing.
First, in most cases, the end of a guide wire already placed in the living body is inserted into the opening 25a of the distal end member of the stent delivery system shown in FIGS. 1 and 2, and a guide wire (not shown) is inserted through the opening 23. Put out. Next, the stent is inserted into a guiding catheter (not shown) inserted into the living body, the stent delivery system 1 is pushed along the guide wire, and the stent housing tubular member 5 is inserted into the target stenosis. Position the stent storage site.
Next, after pressing the operation rotary roller 61 of the operation unit 10, the roller is rotated in the direction of the arrow in FIG. At this time, even when the movable part 4 is located closer to the proximal side than the insertion port of the guiding catheter, or even when the movable part 4 is all inserted into the guiding catheter, It is possible to fix the movable part 8 with a hand or a hemostatic valve (that is, it is not necessary to change the degree of fixation between the movable part and the non-movable part). Thereby, the pulling wire 6 is wound around the outer peripheral surface of the winding shaft 63, and the movable portion 4 (the tubular member 5 for storing the stent and the slide tube 7) moves to the rear end side in the axial direction. At this time, since the rear end surface of the stent 3 is brought into contact with and locked to the distal end surface of the stent rear end locking portion 22 of the distal tube 20, the stent 3 can be stored with the movement of the stent storing tubular member 5. It is discharged from the tip opening of the cylindrical member 5. By this release, as shown in FIG. 10, the stent 3 is self-expanding to expand the stenosis part and is placed in the stenosis part.

Next, the stent delivery system 200 of the embodiment shown in FIGS. 20 to 22 will be described.
FIG. 20 is a partially omitted external view of a stent delivery system according to another embodiment of the present invention. FIG. 21 is an enlarged cross-sectional view of the distal end portion of the stent delivery system of FIG. 22 is an enlarged cross-sectional view of a rear end portion of the stent delivery system of FIG.
The

stent delivery system

1, 40, 100 of the above-described embodiment is a so-called rapid exchange type in which the guide wire insertion opening 23 is provided on the distal end side, whereas the stent delivery system of this embodiment The so-called over-the-wire type 200 has a guide wire lumen that continues from the rear end to the front end.
The stent delivery system 200 of this embodiment includes an inner tube 102 having a guide wire lumen 121 and an outer tube that partially encloses the inner tube 102 (specifically, the distal end side of the inner tube 102 protrudes). 104, a movable part (stent housing tubular member) 105 enclosing the distal end side of the inner tube 102 and slidable in the rear end direction of the inner tube 102, and housed in the stent housing tubular member 105 One end is fixed to the stent 103 and the stent-accommodating tubular member 105, and extends in the outer tube 104 (specifically, in the lumen formed by the inner tube 102 and the outer tube 104) and the outer tube 104. By pulling to the rear end side, the stent housing tubular member 105 is moved to the rear end side. And a pulling member 106 of the fit.

The inner tube 102 and the outer tube 104 are fixed to a branch hub 140 provided at the rear end. The inner tube 102 opens at the rear end thereof and communicates with an opening 143 of the inner tube hub 142 described later. The inner tube 102 is located on the distal end side thereof, abuts against the rear end of the stent 103 housed in the stent housing tubular member 105, and restricts the movement of the stent 103 toward the rear end side of the stent 103. Is provided.
The stent 103 is formed in a substantially cylindrical shape, and is stored in the stent-accommodating tubular member 105 in a compressed state in the central axis direction, and is expanded outwardly and restored to the shape before compression when placed in the living body. Is. The stent 103 is the same as the stent 3 described above.
The stent delivery system of this embodiment includes an inner tube 102, an outer tube 104, a stent housing tubular member 105, a stent 103, a pulling member 106, and a branch hub 140.
In the stent delivery system 200 of this embodiment, the distal end side of the inner tube 102 is partially encapsulated and the rear end side of the stent housing tubular member 105 is encapsulated. And a non-movable part (fixed tube) 108 fixed. In the stent delivery system 200 of this embodiment, the fixed tube 108 is encapsulated without restricting the movement of the stent housing tubular member 105 to the rear end side, and one end portion of the traction member 106 is The traction member 106 passes through the lumen formed by the fixed tube 108 and the inner tube 102 and extends into the outer tube 104. Yes.

The stent housing tubular member 105 is a tubular body having a predetermined length. The front end and the rear end are open. The distal end opening functions as a discharge port of the stent 103 when the stent 103 is placed in a stenosis portion in the living body. When the stent 103 is released from the distal end opening, the stress load is released and the stent 103 expands and is restored to the shape before compression.
Further, in this embodiment, the stent-accommodating tubular member 105 includes a slit 152 extending from the rear end toward the front end as shown in FIG. In the slit 152, a protrusion (in this embodiment, the tubular member 109 through which the pulling member penetrates) formed on the outer surface of the inner tube 102 can be advanced. In this embodiment, the stent-accommodating tubular member 105 is movable to the rear end side until the end portion on the front end side of the slit comes into contact with the tubular member 109. Therefore, the slit 152 is equal to or slightly longer than the length from the rear end of the stent 103 to the front end of the stent housing tubular member 105 in the stent housing tubular member 105 housing the stent 103.
And also in the stent delivery system 200 of this Example, the cylindrical member 105 for stent accommodation which is a movable part has a slidable outer surface. The slidable outer surface is desirably the entire stent-accommodating tubular member 105, but may be only the distal end side portion exposed from the fixed tube 108. In other words, in the state in which the stent-accommodating tubular member 105 shown in FIG. 20 accommodates the stent, the portion of the stent-accommodating tubular member 105 located within the fixed tube 108 is not a slidable outer surface. It may be a thing. As the slidable outer surface, the same ones as described above are suitable. And the outer surface of the fixed tube 108 which is a non-movable part has a higher sliding resistance than the slidable outer surface of the stent housing tubular member 105. The means for setting the outer surface to have a high sliding resistance is as described above. Moreover, the outer surface of the outer tube 104 also has a high sliding resistance.

Further, in the stent delivery system 200 of this embodiment, the fixed tube 108 that is a non-movable part can be distinguished from the stent housing tubular member 105 that is a movable part and the rear end side part (outer tube 104) from the fixed tube 108. Have a good color. The fixing tube 108 may have any color, but is preferably a color other than red because it is inserted into a living body such as a blood vessel. Specifically, green, yellow, blue, black and white are preferable. The fixing tube 108 can be colored, for example, by adding a colorant to the forming material of the fixing tube 108. In addition, dyes and pigments used as colorants include Bengala and Stronel Green as inorganic pigments, quinacridone, perylene, anthraquinone, and carbon black as organic pigments, and perylene and perinone as dyes. , Anthraquinone type, and heterocyclic type. Moreover, you may form the coloring of a fixed tube by laminating | stacking a colored layer on the resin base material layer of a fixed tube. The colored layer can be formed by adding the above-described colorant to a resin material having adhesiveness with the forming material of the fixing tube.

A distal end member 125 is fixed to the distal end of the inner tube 102. The distal end member 125 is preferably formed in a tapered shape that is located on the distal end side from the distal end of the stent housing tubular member 105 and that gradually decreases in diameter toward the distal end. By forming in this way, the insertion into the constricted portion is facilitated. Further, the rear end of the distal end member 125 can be brought into contact with the distal end of the stent housing tubular member 105 and functions as a stopper that prevents the stent housing tubular member from moving in the distal direction. Yes.
Moreover, it is preferable that the latching | locking part 122 provided in the inner side tube 102 is a cyclic | annular protrusion part. The distal end side of the stent locking portion 122 is a stent housing portion. The outer diameter of the locking portion 122 is a size that can contact the rear end of the compressed stent 103.
In the stent delivery system of this embodiment, the traction member 106 is constituted by a traction wire. Further, as shown in FIGS. 20 to 22, the pulling member 106 passes through the outer tube 104 and extends from the rear end of the outer tube 104. As the pulling wire, those described above are preferably used.

As shown in FIG. 22, the branch hub 140 has an opening 143 communicating with the guide wire lumen 121, and communicates with the inner tube hub 142 fixed to the rear end portion of the inner tube 102 and the inside of the outer tube 104. An outer tube hub 141 having a branch portion 144 and fixed to the rear end portion of the outer tube 104 is provided. The small-diameter portion 142a of the inner tube hub 142 enters into the rear end portion of the outer tube hub 141 and is fixed.
The pulling member 106 extends from the rear end opening 145 of the branching portion 144 of the branching hub 140. In this embodiment, the pulling member 106 includes an operation member 162 fixed to the rear end. The operation member 162 is formed so as to encapsulate the rear end portion of the pulling member 106 and the bulging portion 164 formed at the rear end of the pulling member 106. In this embodiment, the operation member 162 includes a through hole 163 into which a finger or the like can enter.
Note that the over-the-wire type stent delivery system as in this embodiment may also include an operation unit having a pulling wire winding mechanism as provided in the above-described stent delivery system 1. Also in the over-the-wire type stent delivery system as in this embodiment, as in the stent delivery system 100 described above, the stent housing tubular member 105 which is a movable part is fixed as a non-movable part when it is movable. The tube 108 may be encapsulated.

The stent delivery system of the present invention is as follows.
(1) A stent that is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into a living body, and expands outward when placed in the living body; a tubular body having a guide wire lumen; and the stent in the distal end portion A movable part including a cylindrical member for storing a stent, and a non-movable part located at a rear end side of the movable part and partially encapsulating the tubular main body, and the stent has the tubular shape The movable part is arranged so as to cover the front end part of the main body and the movable part is moved to the rear end side with respect to the tubular main body, so that the rear end part enters the non-movable part or the A stent delivery system that encapsulates an outer surface of a non-movable part and exposes the stent from the stent-accommodating tubular member, wherein the movable part has a slidable outer surface. And a stent delivery system in which at least a part of the outer surface of the non-movable part has a higher sliding resistance than the outer surface of the movable part.
For this reason, even if the movable part is firmly fixed by hand or a hemostasis valve during use, the entire movable part has good slidability, so that the movable part moves to the rear end side, that is, the stent is exposed. When the non-movable part tube is tightly fixed by the above-described hemostasis valve or the like, the non-movable part has high sliding resistance, so that the fixed state is maintained well and The movement of the movable part is suppressed, and the movement to the rear end side of the movable part, that is, the stent exposure operation can be performed satisfactorily.

And as an embodiment of the present invention, the following may be sufficient.
(2) The movable portion includes a slide tube that moves to the rear end side together with the stent-housing tubular member, and the slide tube has a slidable outer surface. Stent delivery system.
(3) The stent delivery system according to (1) or (2), wherein all outer surfaces of the non-movable part have higher sliding resistance than the outer surface of the movable part.
(4) The movable portion is configured such that a rear end portion enters the non-movable portion by moving the movable portion toward the rear end side with respect to the tubular main body, and the non-movable portion. Is a stent delivery system according to any one of the above (1) to (3), which has a color distinguishable from the movable part.
The movable part moves the movable part to the rear end side with respect to the tube-shaped main body so that the rear end part enters the non-movable part, and the non-movable part can be distinguished from the movable part. If it has a color, the movable part and the non-movable part at the time of the stent opening operation can be reliably and easily recognized.
(5) The movable part moves the movable part toward the rear end side with respect to the tubular main body so that the rear end part encloses the outer surface of the non-movable part, and The part of the movable part that is not encapsulated by the movement of the movable part has a color that can be distinguished from the part that is encapsulated by the movement of the movable part and the movable part of the non-movable part. The stent delivery system according to (2).
The movable part moves the movable part to the rear end side with respect to the tube-shaped main body so that the rear end covers the outer surface of the non-movable part, and the movable part moves by moving the non-movable part. The unencapsulated part has a color that can be distinguished from the part to be encapsulated by the movement of the movable part and the movable part of the non-movable part. It is possible to reliably and easily recognize the appearance changing portion and the appearance non-changing portion to be wrapped.
(6) The movable part moves the movable part toward the rear end side with respect to the tubular main body, so that the rear end portion encloses the outer surface of the non-movable part, and the non-movable part The stent delivery system according to (1), (2), or (5), wherein the movable part is a slidable outer surface at a portion encapsulated when the movable part is moved.
(7) The stent delivery system according to any one of (1) to (6), wherein the cylindrical member for storing a stent has transparency capable of visually recognizing the stent to be stored.
(8) The tubular body according to any one of (1) to (7), wherein the tubular main body includes a stent rear end direction movement restraining portion that is located on a front end side and is close to or abuts on the rear end of the stent. Stent delivery system.
(9) The tubular body includes a distal end side tube having a guide wire lumen and a rear end side tube, and the non-movable part includes a rear end portion of the distal end side tube and a distal end portion of the rear end side tube. The stent delivery system according to any one of the above (1) to (8), wherein an opening that communicates with the guide wire lumen is provided.
(10) In the stent delivery system, one end of the stent is fixed to the movable part, extends in the non-movable part and is pulled toward the rear end side of the non-movable part. The stent delivery system according to any one of the above (1) to (9), comprising at least one pulling member for moving to the side.
(11) In the above (10), the stent delivery system includes an operation unit including a pulling member winding mechanism for winding the pulling member and moving the stent-accommodating tubular member to the rear end side. The stent delivery system as described.

Claims

A stent that is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into a living body, and is expandable outward when placed in the living body, a tubular body having a guide wire lumen, and a stent that houses the stent in a distal end portion A movable part including a cylindrical member for storage; a non-movable part located on the rear end side of the movable part and partially encapsulating the tubular main body; and the stent includes a distal end of the tubular main body The movable portion is arranged so as to cover the portion, and the movable portion moves toward the rear end side with respect to the tubular main body, so that the rear end portion enters the non-movable portion or the non-movable portion. And a stent delivery system in which the stent is exposed from the stent-accommodating tubular member,
The movable part has a slidable outer surface, and at least a part of the outer surface of the non-movable part has a higher sliding resistance than the outer surface of the movable part. Stent delivery system.
The stent delivery system according to claim 1, wherein the movable portion includes a slide tube that moves to a rear end side together with the cylindrical member for stent storage, and the slide tube has a slidable outer surface.
The stent delivery system according to claim 1 or 2, wherein all outer surfaces of the non-movable part have higher sliding resistance than an outer surface of the movable part.
The movable part is a part in which a rear end part enters the non-movable part by moving the movable part to the rear end side with respect to the tubular main body, and the non-movable part is The stent delivery system according to any one of claims 1 to 3, wherein the stent delivery system has a color distinguishable from a movable part.
The movable part moves the movable part to the rear end side with respect to the tubular main body so that the rear end part envelops the outer surface of the non-movable part, and the non-movable part The part not encapsulated by the movement of the movable part has a color distinguishable from the part encapsulated by the movement of the movable part and the non-movable part of the movable part. Stent delivery system.
The movable part moves the movable part to the rear end side with respect to the tubular main body, so that the rear end part encloses the outer surface of the non-movable part, and the non-movable part is The stent delivery system according to claim 1, 2 or 5, wherein a portion encapsulated when the movable portion is movable has a slidable outer surface.
The stent delivery system according to any one of claims 1 to 6, wherein the stent-housing tubular member has transparency so that the stent to be housed can be visually recognized.
The stent delivery system according to any one of claims 1 to 7, wherein the tubular main body includes a stent rear end direction movement restraining portion that is located on a front end side and is close to or abuts on the rear end of the stent.
The tubular main body includes a distal end side tube having a guide wire lumen and a rear end side tube, and the non-movable part fixes a rear end portion of the distal end side tube and a distal end portion of the rear end side tube. The stent delivery system according to any one of claims 1 to 8, further comprising an opening communicating with the guide wire lumen.
The stent delivery system has one end fixed to the movable part, extends through the non-movable part, and pulls to the rear end side of the non-movable part, thereby moving the stent storage tubular member to the rear end side. The stent delivery system according to any one of claims 1 to 9, further comprising at least one traction member.
The stent delivery system according to claim 10, wherein the stent delivery system includes an operation unit having a pulling member winding mechanism for winding the pulling member and moving the stent-accommodating tubular member to the rear end side. system.