JP2011015811A - Living organ dilator - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a living organ dilator which has two self-expanding stents and can excellently indwell the respective stents at a target part.SOLUTION: The living organ dilator 1 includes: the first stent 3 and second stent 4 of a self-expanding type; a tubular body provided with a guide wire lumen 21; and a stent storage cylindrical member 5 for storing the stents 3 and 4 inside a distal end part and exposing the stents 3 and 4 by moving them to the proximal end side. The second stent 4 is disposed more on the proximal end side than the first stent 3 by a prescribed length. The biological organ dilator 1 is provided with a first proximal end direction movement suppression part 31 close or abutted to the rear end of the first stent 3 and provided with an imaging property and a second proximal end direction movement suppression part 41 close or abutted to the rear end of the second stent 4 and provided with an imaging property.

Description

  The present invention relates to a biological organ dilator 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 biological organ dilator that secures a lumen or body cavity space by placing a stent in a stenosis or occlusion of a body lumen or body lumen such as blood vessels, bile ducts, esophagus, trachea, urethra, digestive tract, and other organs Has been proposed.
Stents delivered by the living organ dilator include balloon expandable stents and self-expandable stents depending on the function and placement method.
The balloon expandable stent does not have an expansion function. To place the stent at the target site, for example, after the stent is inserted to the target site, the balloon is positioned in the stent and the balloon is expanded. The stent is expanded (plastically deformed) by force and is fixed in close contact with the inner surface of the target site.
This type of stent requires the above-described stent expansion operation, but it can be placed by directly attaching the stent to a deflated balloon, so that there is not much problem with placement.

In contrast, a self-expanding stent has a contraction and expansion function. In order to place the stent in the target site, the stress applied to maintain the contracted state is removed after the stent is inserted into the target site in the contracted state. For example, the stent is contracted and stored 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 pushed out of the sheath. The extruded stent is released from the sheath to release the stress load, and restores and expands to the shape before contraction. 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 is no problem that the diameter gradually decreases due to blood pressure or the like and restenosis occurs.
In many cases, a stenosis in a blood vessel develops in a short region, but may occur in a region having a predetermined length, or may occur in two locations in close proximity.
As disclosed in Japanese Patent Laid-Open No. 2005-118571 (Patent Document 1), there is one in which one stent is constituted by a plurality of stents.

JP 2005-118571 A

However, in Patent Document 1, it is difficult to place individual stents at arbitrary sites, although they are separated into a plurality of stents, and it is not easy to grasp the stent at the time of in vivo placement. It was difficult to arrange it well.
An object of the present invention is to provide a living organ dilating device including two self-expanding stents, which can satisfactorily place each stent at a target site.

(1) First and second stents that are formed in a substantially cylindrical shape, are compressed in the direction of the central axis when inserted into the living body, and can be expanded outward when placed in the living body; a tubular body having a guide wire lumen; A stent-containing tubular member that houses the first and second stents in the distal end portion, and the first and second stents are disposed so as to cover the distal end portion of the tubular body, and A biological organ dilator that can expose the first and second stents by moving a tubular member for stent storage to the proximal end side with respect to the tubular main body,
The second stent is disposed at a proximal end side of a predetermined length from the first stent, and the biological organ dilating instrument is close to or abuts on the rear end of the first stent and has a contrast property. A biological organ dilating instrument comprising: 1 proximal-direction movement restraint portion; and a second proximal-direction motion restraint portion that is close to or in contact with the rear end of the second stent and has contrast.

(2) The tube-shaped main body includes a distal-end-direction movement suppressing portion for a first stent that is located on a distal end side of the tube-shaped main body and is close to or in contact with the distal end of the first stent. The living organ dilator described in (1).
(3) The tube-shaped main body includes a distal-end-direction movement suppressing portion for a second stent that is located on a distal end side of the tubular main body and is close to or in contact with the distal end of the second stent. ) Or (2) a living organ dilator.
(4) The living body organ expansion according to any one of (1) to (3), wherein the tubular main body includes a reinforcing portion extending in a proximal direction toward a predetermined length from the first proximal direction movement restraining portion. Instruments.
(5) The living organ expansion according to any one of (1) to (4), wherein the tubular main body includes a reinforcing portion that extends in a proximal direction toward a predetermined length from the second proximal direction movement suppressing portion. Instruments.
(6) The tube-shaped main body includes a reinforcing portion that reaches the vicinity of the distal end portion of the second stent or within the distal end portion from the first proximal direction movement restraining portion. The living organ dilator according to any one of the above.
(7) The rear end portion of the first proximal direction movement restraining portion and / or the second proximal direction movement restraining portion is a tapered portion that decreases in diameter toward the proximal direction (1) ) To (6), the living organ dilator.
(8) The living organ expansion device according to any one of (1) to (7), wherein a distal end portion of the stent-housing tubular member has a contrast property.
(9) The tubular member for storing a stent is any one of the above (1) to (8), wherein a portion for storing the first stent and a portion for storing the second stent are flexible portions. The living organ dilator described in 1.
(10) The living organ expansion device according to any one of (1) to (9), wherein the first stent and the second stent have different outer diameters when expanded.

(11) The tubular body includes a distal end side tube having a guide wire lumen, a proximal end side tube, a proximal end portion of the distal end side tube, and a distal end portion of the proximal end side tube, and the guide wire. The living organ dilator according to any one of (1) to (10) above, comprising a fixed tube having an opening communicating with the lumen.
(12) The biological organ dilating instrument has one end fixed to the tubular member for stent storage, extends in the tubular main body, and is pulled toward the proximal end of the tubular main body, thereby The living organ dilator according to any one of the above (1) to (11), comprising at least one pulling wire for moving the tubular member to the proximal end side.
(13) In the above (12), the tubular body includes an operation unit including a pulling wire winding mechanism for winding the pulling wire and moving the stent-accommodating tubular member to the proximal end side. Living organ expansion device.
(14) The living body organ expanding device according to any one of (11) to (13), wherein the living body dilating instrument includes a linear rigidity imparting body that passes through the proximal end side tube and enters the fixed tube. Organ dilator.
(15) The living organ dilator according to (14), wherein the operation unit includes a lock mechanism that releasably locks the rotation of the pulling wire winding mechanism.
(16) The operation unit according to (14) or (15), further including a reverse rotation restricting mechanism that restricts rotation of the pulling wire winding function in a direction opposite to a winding direction of the pulling wire. Biological organ dilator.
(17) The pulling wire winding mechanism is provided with an operation rotating roller and a winding shaft portion coaxially and integrally with the operation rotating roller and having a diameter smaller than that of the operation rotating roller. The living organ dilator according to any one of (14) to (16), wherein a proximal end portion of the pulling wire is fixed to a take-off shaft portion.

  The living organ dilator according to the present invention is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into the living body, and expands outward when placed in the living body, and can be restored to the shape before compression. And a tubular main body having a guide wire lumen, and a tubular member for accommodating a stent in which the first and second stents are housed in the distal end portion, and the first and second stents are of the tubular main body. The first and second stents can be exposed by moving the tubular member for accommodating the stent toward the proximal end side with respect to the tubular main body, so as to cover the distal end portion. The second stent is disposed close to the rear end portion of the first stent and on the proximal side with a predetermined length. The biological organ dilator has a first proximal direction movement restraining portion that is close to or abuts on the rear end of the first stent and has a contrast property, and is close to or abuts on the rear end of the second stent and is contrasted. A second proximal-direction movement restraining portion having a property of the first stent, the first stent can be satisfactorily disposed at a target site by using the first proximal-direction movement restraining portion having a contrast property. Furthermore, since the second stent is located between the first proximal direction movement suppression unit having contrast and the second proximal direction movement suppression unit having contrast, the position of the second stent can be grasped. By using the second proximal direction movement restraining portion that is easy and has a contrast property located in the vicinity of the rear end of the second stent, it can be satisfactorily disposed at the target site.

FIG. 1 is a partially omitted external view of a living organ dilator according to an embodiment of the present invention. FIG. 2 is an enlarged external view of the distal end portion of the living organ dilator shown in FIG. FIG. 3 is an enlarged cross-sectional view of the distal end portion of the living organ dilator shown in FIG. FIG. 4 is an enlarged cross-sectional view of the vicinity of the stent-accommodating tubular member of the living organ dilator of FIG. FIG. 5 is an enlarged cross-sectional view of the vicinity of the slide tube of the living organ dilator shown in FIG. FIG. 6 is an enlarged cross-sectional view of the vicinity of the fixed tube of the living organ dilator shown in FIG. FIG. 7 is an enlarged cross-sectional view taken along line AA in FIG. FIG. 8 is an enlarged cross-sectional view taken along line BB in FIG. FIG. 9 is an enlarged cross-sectional view taken along line CC in FIG. FIG. 10 is an enlarged cross-sectional view of the proximal end portion of the tubular member for stent storage and the vicinity of the distal end portion of the slide tube of the living organ dilator shown in FIG. FIG. 11 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention. FIG. 12 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention. FIG. 13 is an enlarged cross-sectional view of a distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 14 is an enlarged cross-sectional view of the distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 15 is an enlarged cross-sectional view of a distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 16 is an enlarged cross-sectional view of the distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 17 is an enlarged cross-sectional view of a distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 18 is an enlarged cross-sectional view of the distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 19 is an enlarged cross-sectional view of the vicinity of a proximal end portion of a stent housing tubular member of a living organ dilating instrument according to another embodiment of the present invention. FIG. 20 is an external view of an example of a stent used in the living organ dilator according to the present invention. FIG. 21 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to the present invention. FIG. 22 is an enlarged rear view of the vicinity of the operation unit of the biological organ dilator shown in FIG. FIG. 23 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG. FIG. 24 is a right side view of only the operation portion of the living organ dilator shown in FIG. FIG. 25 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG.

The living organ dilator according to the present invention will be described with reference to examples.
The living organ expansion device 1 of the present invention is formed in a substantially cylindrical shape, is compressed in the central axis direction when inserted into a living body, and expands outward when placed in the living body to be restored to a shape before compression. 3 and the second stent 4, a tubular main body having a guide wire lumen 21, a stent housing tubular member 5 housing the first stent 3 and the second stent 4 in the distal end portion, and The first stent 3 and the second stent 4 are arranged so as to cover the distal end portion of the tubular body, and the tubular member 5 for accommodating a stent is moved to the proximal end side with respect to the tubular body, whereby the first The stent 3 and the second stent 4 can be exposed. The second stent 4 is arranged on the proximal end side with a predetermined length from the first stent 3. The living organ dilator 1 is in proximity to or in contact with the rear end of the first stent 3 and close to or in contact with the rear end of the second stent 4 and the first proximal direction movement restraining portion 31 having contrast. And a second proximal direction movement suppression unit 41 having contrast properties.

The living organ dilator 1 of the present invention includes a tubular body 5 for housing a stent, which houses a tubular main body having a guide wire lumen 21, a self-expanding first stent 3 and a self-expanding second stent 4. With.
In the living organ dilator 1 of this embodiment, the tubular main body includes the distal end side tube 2 having the guide wire lumen 21, the proximal end side tube 9, and the proximal end portion and the proximal end side tube of the distal end side tube 2. 9 and a fixed tube 8 having an opening 23 communicating with the guide wire lumen 21. In addition, as a structure of a tubular main body, it is not limited to such a thing. Further, in the living organ dilator 1 of this embodiment, one end portion is fixed to the stent-accommodating tubular member 5 and extends inside the tubular main body and is pulled to the proximal end side, thereby the stent-accommodating tubular member 5. There is provided a pulling wire 6 (6a, 6b) which constitutes a moving means for moving the base to the base end side. Further, the living organ dilator 1 of this embodiment is configured to wind a pulling wire 6 around the proximal end portion of the tubular main body, and to wind the pulling wire for moving the stent housing tubular member 5 to the proximal end side. It has a mechanism.

  The living organ dilator 1 of this embodiment includes a distal end side tube 2, a first stent 3, a second stent 4, a proximal end side tube 9, a stent housing tubular member 5, a pulling wire 6, a slide tube 7, An operation unit 10 having a winding mechanism for the fixed tube 8 and the pulling wire 6 is provided. The fixed tube 8 connects the distal end side tube 2 and the proximal end side tube 9 and includes an opening 23 communicating with the proximal end portion of the distal end side tube 2.

  As shown in FIGS. 1 to 10, the distal-side tube 2 is a tube body having a guide wire lumen 21 that penetrates from the distal end to the proximal 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. The distal tube 2 is fixed to the fixed tube 8 at the proximal end. The proximal end of the distal tube 2 communicates with an opening 23 formed in the fixed tube 8. Further, the proximal end portion of the distal end side tube 2 is curved as shown in FIG. Further, as shown in FIGS. 1 and 6, the opening 23 is formed obliquely so as to be inclined toward the base end side. This facilitates guide wire guidance.

  As shown in the drawing, the distal tube 2 is a tube body having a guide wire lumen 21 penetrating from the distal end to the proximal end. The distal tube 2 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 700 mm, preferably 30 to 550 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 forming in this way, the insertion into the constricted portion is facilitated. Moreover, it is preferable that the distal end side tube 2 is provided with a stopper that is provided on the distal end side with respect to the first stent 3 and prevents movement of the stent housing tubular member in the distal end direction. In this embodiment, the proximal 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.
In addition, it is preferable that the outer diameter of the most distal end portion of the tip member (tip portion) 25 is 0.5 mm to 1.8 mm. Moreover, it is preferable that the outer diameter of the largest diameter part of the front-end | tip member (front-end | tip part) 25 is 0.8-4.0 mm. Furthermore, the length of the tip side tapered portion is preferably 2.0 to 20.0 mm.

Further, as shown in FIGS. 1 to 4, the distal tube 2 is positioned at a position that is a predetermined distance proximal from the distal end of the tube 2 in order to restrict movement of the first stent 3 toward the proximal end. The provided first stent proximal direction movement restraint part (first proximal direction movement restraint part) 31 and a position that is closer to the proximal side by a predetermined distance than the first stent proximal direction movement restraint part 31 A provided second stent proximal direction movement restraining part (second proximal direction movement restraining part) 41 is provided.
The stent proximal direction movement restraining portions 31 and 41 are preferably annular projecting portions. The distal end side of the second stent proximal direction movement restraining portion 41 is a stent housing portion. The outer diameter of the first proximal direction movement restraining portion 31 is large enough to contact the proximal end of the compressed first stent 3. And even if the stent-accommodating tubular member 5 moves to the proximal end side, the stent 3 maintains the arrangement position by the first proximal-direction movement restraining portion 31. As a result, it is released. Similarly, the outer diameter of the stent proximal direction movement restraining portion 41 is a size capable of coming into contact with the proximal end of the compressed stent 4. And even if the stent-accommodating tubular member 5 moves to the proximal end side, the stent 4 is maintained at the arrangement position by the second proximal-direction movement suppressing portion 41. As a result, it is released.

The first proximal direction movement suppression unit 31 has contrast properties (specifically, X-ray contrast properties and ultrasonic contrast properties). The entire first proximal direction movement suppression unit 31 preferably has a contrast property, but the distal side portion of the first proximal direction movement suppression unit 31 needs to have at least a contrast property. Furthermore, in this embodiment, the first proximal direction movement restraining portion 31 has a cylindrical portion that extends with substantially the same outer diameter and a tapered portion that decreases in diameter toward the proximal direction from this cylindrical portion. It has become.
Similarly, the second proximal direction movement suppression unit 41 has contrast properties (specifically, X-ray contrast properties and ultrasonic contrast properties). The entire second proximal direction movement suppression unit 41 preferably has contrast, but the distal side portion of the second proximal direction movement suppression unit 41 needs to have at least contrast. Furthermore, in this embodiment, the second proximal direction movement restraining portion 41 has a cylindrical portion that extends with substantially the same outer diameter and a tapered portion that decreases in diameter toward the proximal direction from the cylindrical portion. It has become.

  And the provision of the contrast property to the 1st base end direction movement suppression part 31 and the 2nd base end direction movement suppression part 41, for example, fitting of the contrast member to the outer surface of these locking parts, locking The portion can be formed by forming a contrast agent material, or by adding a contrast agent to the engaging portion forming material. As the X-ray contrast material used for the contrast member or contrast agent material, for example, gold, platinum, platinum-iridium alloy, silver, tantalum, stainless steel, platinum, or alloys thereof are suitable. The contrast member is attached 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. When contrast is imparted by adding a contrast agent to the engaging portion forming material, 31 and 41 are formed of a synthetic resin containing an X-ray contrast agent. As the X-ray contrast agent, for example, fine powders of tungsten, barium sulfate, bismuth, bismuth oxide, gold, platinum and the like are preferable.

  Furthermore, in this embodiment, the tube-shaped main body (specifically, the distal end side tube 2) includes a reinforcing portion 43 that extends in the proximal direction toward the predetermined length from the first proximal direction movement suppression portion 31. In this embodiment, the reinforcing portion 43 is formed of a thin tube fixed to the outer surface of the distal end side tube 2. The base end part of the reinforcement part 43 reaches | attains the 2nd front-end | tip direction movement suppression part 42 mentioned later. Further, the distal end portion of the reinforcing portion 43 protrudes further toward the distal end side than the first proximal direction movement suppressing portion 31. Therefore, the reinforcing part 43 reinforces a predetermined length part before and after the first proximal direction movement suppressing part 31. Further, in this embodiment, the first proximal direction movement restraining portion 31 is fixed to the reinforcing portion 43.

In this embodiment, the tube-shaped main body (specifically, the distal end side tube 2) includes a reinforcing portion 44 that extends in the proximal direction toward the predetermined length from the second proximal direction movement suppression portion 41. In this embodiment, the reinforcing portion 44 is formed of a thin tube fixed to the outer surface of the distal end side tube 2. Further, the distal end portion of the reinforcing portion 44 protrudes further toward the distal end side than the second proximal direction movement suppression portion 41. Therefore, the reinforcing portion 44 reinforces a predetermined length portion before and after the second proximal direction movement suppressing portion 41. In this embodiment, the second proximal direction movement restraining portion 41 is fixed to the reinforcing portion 44.
As a material for forming the thin-walled tube constituting the reinforcing portions 43 and 44, it is desirable to have a certain degree of hardness. For example, fluorine-based polymers such as polyethylene, polypropylene, nylon, polyethylene terephthalate, polyimide, PTFE, ETFE, PEEK (polyethylene) Hard or semi-rigid materials such as ether ether ketone) and polyimide are suitable.

  In the living organ dilator 1 of this embodiment, the distal tube 2 has a predetermined length (substantially the first stent 3 of the first stent 3) than the first proximal direction movement restraining portion 31 as shown in FIGS. A first distal direction movement restraining portion (first stent distal direction movement restraining portion) 32 provided at a position on the distal end side in the axial direction is provided. As shown in FIGS. 3 and 4, the first distal direction movement restraining portion 32 is located slightly on the proximal side from the distal end of the stent housing tubular member 5. The first distal direction movement restraining part 32 is preferably an annular projecting part. And between this 1st front end direction movement suppression part 32 and the 1st base end direction movement suppression part 31 mentioned above is a 1st stent accommodation site | part. The outer diameter of the first distal direction movement restraining portion 32 is a size that can contact the distal end of the compressed first stent 3. Further, the first distal direction movement restraining portion 32 is a tapered surface whose proximal end surface is reduced in diameter toward the proximal direction. Therefore, when the stent is released, the first distal-direction movement restraining portion 32 does not become an obstacle, and is pulled back to the proximal end side of the living organ expanding device 1 after the release of the stent 3 and taken out after the release. Becomes easy.

  Furthermore, in the living organ dilator 1 of this embodiment, the distal side tube 2 has a predetermined length (substantially the second stent 4 of the second stent 4) as shown in FIGS. A second distal direction movement restraining portion (second stent distal direction movement restraining portion) 42 provided at a position on the distal side is provided. As shown in FIGS. 3 and 4, the second distal direction movement restraining portion 42 is located on the proximal side of a predetermined length from the distal end of the stent housing tubular member 5. It is preferable that the 2nd front-end | tip direction movement suppression part 42 is a cyclic | annular protrusion part. And between this 2nd distal direction movement suppression part 42 and the above-mentioned 2nd proximal direction movement suppression part 41 is a 2nd stent accommodation site | part. The outer diameter of the second distal direction movement restraining portion 42 is a size that can contact the distal end of the compressed second stent 4. Further, the second distal direction movement restraining portion 42 is a tapered surface whose proximal end surface is reduced in diameter toward the proximal end. Therefore, when the stent is released, the second distal direction movement restraining portion 42 does not become an obstacle, and the recovery of the living organ dilator 1 after the release of the stent 4 (specifically, a guiding catheter or Storage in the sheath) is facilitated. Further, in this embodiment, the second distal direction movement restraining part 42 is provided at a position that is a predetermined length proximal side from the first proximal direction movement restraining part 31 described above. For this reason, the stent-accommodating tubular member 5 includes a stent non-accommodating portion located between the first stent accommodating part and the second stent accommodating part. The distance between the first proximal direction movement suppression unit 31 and the second distal direction movement suppression unit 42 is preferably 2 to 20 mm, and particularly preferably 5 to 15 mm.

  The outer diameters of the stent proximal direction movement suppressing portions 31 and 41 and the stent distal direction movement suppressing portions 32 and 42 are preferably 0.8 to 4.0 mm. The movement restraining portions 31, 32, 41, and 42 are preferably annular projections as shown in the figure, but may be any one that restricts the movement of the stent and can be extruded, and is integrated with the distal tube 2, for example. Alternatively, it may be one or a plurality of protrusions provided as separate members. In addition, the stent tip direction movement restraining portions 32 and 42 may have contrast properties (specifically, X-ray contrast properties and ultrasonic contrast properties). For the provision of contrast to the stent distal direction movement restraining portions 32 and 42, those described in the stent proximal direction movement restraining portions 31 and 41 can be suitably used.

  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. (Polyetheretherketone), polyimide and the like can be preferably used. In particular, among the above resins, a resin having thermoplasticity is preferable. Note that the exposed outer surface of the distal tube may be coated with a resin having biocompatibility, particularly antithrombogenicity. 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 preferably used.

  Further, when the distal end portion is constituted by a member different from the tube, it is preferable to use a material having flexibility as the distal end portion (tip 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 living organ dilator 1 of this embodiment, the distal tube 2 and the distal member 25 are formed as separate members, and the distal tube 2 has a stopper member 27 fixed to the distal end. Yes. The stopper member 27 includes a cylindrical portion fixed to the distal end side tube 2 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 6, the proximal tube 9 is a tube body that penetrates from the distal end to the proximal end, and includes an operation unit 10 that is fixed to the proximal end. A distal end portion of the proximal end side tube 9 is joined to the fixed tube 8 by a fixing member 84. The proximal tube 9 includes a pull wire lumen through which the pull wire 6 can be inserted.
The proximal tube 9 has a length of 300 mm to 1500 mm, more preferably 800 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 proximal tube 9 and the central axis of the distal tube 2 is preferably 0.1 to 2.0 mm, and particularly preferably 0.5 to 1.5 mm.

  The material for forming the proximal tube is preferably a material having hardness and flexibility. For example, polyolefins such as polyethylene and polypropylene, fluoropolymers such as nylon, polyethylene terephthalate, and ETFE, and PEEK (polyethylene). Ether ether ketone), polyimide and the like can be preferably used. The outer surface of the proximal tube may be coated with a resin having biocompatibility, particularly antithrombogenicity. 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. In addition, as the material for forming the proximal end side tube 9, it is preferable to use a material having relatively high rigidity. For example, a metal such as Ni—Ti, brass, stainless steel, and aluminum, or a resin having relatively high rigidity, such as polyimide, vinyl chloride, or polycarbonate, can be used.

The stent-housing tubular member 5 is a tubular body having a predetermined length as shown in FIGS. The front end and the rear end are open. The distal end opening functions as a release port of the stent when the first stent 3 and the second stent 4 are placed in the stenosis in the body cavity. As shown in FIGS. 11 and 12, the stent 3 and the stent 4 are released from the distal end opening when the stent housing tubular member 5 moves to the proximal end side, and the stress load is released to expand and compress. Restore the previous shape.
The length of the stent-containing tubular member 5 is preferably 30 mm to 220 mm, and particularly preferably 50 mm to 180 mm. Moreover, as an outer diameter, about 1.0-4.0 mm is preferable, and 1.2-3.0 mm is especially preferable. Moreover, as an internal diameter of the cylindrical member 5 for stent accommodation, about 1.0-2.5 mm is preferable.

  The stent-accommodating tubular member 5 includes a tubular member body 51 having a small-diameter portion 51a provided at the proximal end portion, and a tubular portion 52 provided so as to enclose the small-diameter portion 51a. I have. Note that the base end portion of the small diameter portion 51 a protrudes from the cylindrical portion 52. Specifically, the distal end portion 69 (69a, 69b) of the pulling wire 6 (6a, 6b) enters the space formed between the small diameter portion 51a and the cylindrical portion 52, and the fixing agent filled in the space. By 53, it is being fixed to the cylindrical member 5 for stent accommodation. The small-diameter portion 51a includes a tapered portion whose outer diameter is reduced toward the proximal end side, and a short cylindrical portion extending from the tapered portion toward the proximal end side. And the cylindrical part 52 is being fixed to the base end part of the cylindrical member main-body part 51 so that the reduced diameter part (small diameter part) 51a of the cylindrical member main-body part 51 may be covered. For this reason, the small diameter part 51a of the cylindrical member main-body part 51 comprises the cyclic | annular protrusion part which protrudes inward and the base end direction of the cylindrical member 5. As shown in FIG. An annular space is formed between the annular protrusion and the inner surface of the stent-accommodating tubular member 5 (specifically, the distal end of the proximal-side tubular portion). In this embodiment, the distal end portion 69 (69a, 69b) of the pulling wire 6 (6a, 6b) is fixed on the outer surface of the small diameter portion 51a. The gap is filled with an adhesive, and the tubular member main body 51 and the proximal end tubular portion 52 are integrated. In addition, tip portions (fixed points) 69 (69a, 69b) of the pulling wires 6 (6a, 6b) to be described later are fixed to the cylindrical member 5 by a fixing agent or the like filled in the annular gap. 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.

In the stent housing tubular member 5 used in this embodiment, the tubular member body 51 and the tubular portion 52 have substantially the same outer diameter. As an outer diameter of a cylindrical member main-body part, about 1.0-4.0 mm is preferable, and 1.5-3.0 mm is especially preferable. Further, the length of the cylindrical member body 51 is preferably about 30 to 220 mm, particularly preferably 50 mm to 180 mm, and the length of the proximal end side cylindrical portion 52 is preferably about 3 to 20 mm. 5 mm to 15 mm is preferable.
In addition, as the cylindrical member 5 for stent accommodation, it is not limited to what consists of the above-mentioned cylindrical member main-body part 51 and the base end side cylindrical part 52, The integral thing may be sufficient.

As shown in FIGS. 3 to 5, the slide tube 7 is disposed so that the distal end thereof is close to the proximal end of the stent housing tubular member 5. The slide tube 7 can be stored in the fixed tube from the base end side. The slide tube 7 may be one that can be fitted to the fixed tube 8 from the base end side. The slide tube 7 can move to the proximal 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 living organ dilator 1 in this embodiment includes a ring-shaped member 75 that is housed in the slide tube 7 in a non-fixed state and moves together with the slide tube 7, and the pulling wires 6 a and 6 b are the ring-shaped member 75. It is fixed to the inner surface.
In particular, in the living organ dilator 1 of this embodiment, the ring-shaped member 75 is housed in the slide tube 7 in an unfixed state. For this reason, the fixing portion does not become an obstacle to the pulling of the pulling wire, and even if the twisting force applied at the proximal end portion of the living organ dilator is transmitted to the slide tube, it is fixed to the slide tube. Therefore, a good state can be maintained without twisting.
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 10, the slide tube 7 includes a slide tube main body 71 and a distal end side member that is fixed to the distal end of the slide tube main body 71 and has a larger outer diameter and inner diameter than the slide tube main body 71. . In this embodiment, the distal end side member of the slide tube 7 is, as shown in FIG. 10, a first cylindrical member 72 and a second cylindrical member 72 having 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 proximal 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 proximal end portion of the second tubular 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 proximal end portion of the second tubular member 73 that is the outer tube, and at the same time as the proximal end portion of the third tubular 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 proximal 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 or a plastic cylindrical member (described in the living organ dilating instrument 110 of the embodiment described later) is suitable. As shown in FIG. 10, the pulling wires 6 a and 6 b are fixed to the inner surface of the ring-shaped member 75 by fixing portions 75 a and 75 b. As the fixing portion, welding, an adhesive, or the like is preferable. Since the pulling wires 6a and 6b are fixed to the ring-shaped member 75, the ring-shaped member 75 is also pulled by pulling the pulling wires 6a and 6b, and the ring-shaped member 75 is pushed from the tip side. As a result, the slide tube 7 also moves to the proximal end side of the living organ dilator 1.
The outer diameter of the slide tube main body 71 is preferably about 0.8 to 4.0 mm, and particularly preferably 1.1 to 3.3 mm. Further, the length of the slide tube main body 71 is preferably about 30 to 300 mm, and particularly preferably 50 mm to 250 mm.

Moreover, it is preferable that the front-end | tip part of the slide tube 7 encloses the base end part of the small diameter part 51a of the cylindrical member 5 for stent accommodation. Moreover, it is preferable that the slide tube 7 and the cylindrical member 5 for stent accommodation are not joined. In this embodiment, as shown in FIG. 10, the distal end portion of the slide tube 7 is not bonded or substantially contacted, and the distal end portion of the small diameter portion 51a of the stent-containing tubular member 5 is formed. Encapsulates the end. Specifically, the distal end portion of the first cylindrical member 72 constituting the outer tube portion encapsulates the proximal 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 preferably formed by blade lines. For example, it is a wire blade and can be formed of a metal wire such as stainless steel, an elastic metal, a superelastic alloy, a shape memory alloy having a wire diameter of 0.01 to 0.2 mm, preferably 0.02 to 0.15 mm. Or you may form with synthetic fibers, such as a polyamide fiber, a polyester fiber, and a polypropylene fiber.

As shown in FIGS. 2, 6, and 9, the fixed tube 8 includes a distal-side fixed tube 81 having a large outer diameter and a proximal end portion of the distal-side fixed tube 81 in the living organ dilating instrument 1 of this embodiment. The proximal end side fixed tube 82 fixed to the is provided. The distal-end-side fixed tube 81 includes a distal-end reduced-diameter portion 81a, and the inner surface of the distal-end reduced-diameter portion 81a is in contact with the outer surface of the proximal end portion of the slide tube 7. The slide tube 7 is not fixed to the distal end side fixed tube 81, but enters the distal end side fixed tube 81 and is accommodated by sliding to the proximal end side.
As in this embodiment, the slide tube 7 is preferably of a type that is slidably accommodated in the fixed tube 8, but is not limited to this, and the slide tube is slid to the proximal end side. Therefore, the fixed tube may be of a type fitted with a slide tube.

The distal end portion of the proximal end side fixed tube 82 enters the proximal end of the distal end side fixed tube 81 and is fixed by the fixing portion 81b. Further, on the outer surface of the distal end side tube 2, a slide tube locking portion 24 is provided in the fixed tube 8, specifically, at a position that becomes the proximal end portion of the distal end side fixed tube 81 as shown in FIG. 6. It has been. The slide tube 7 can be slid to the proximal end side until it abuts against the slide tube locking portion 24. In other words, the slide tube 7 is restricted from further movement toward the proximal end side by contacting the slide tube locking portion 24.
The outer diameter of the distal end side fixing tube 81 is preferably about 1.0 to 4.0 mm, and particularly preferably 1.5 to 3.0 mm. Further, the length of the distal end side fixing tube 81 is preferably about 30 to 300 mm, and particularly preferably 50 mm to 250 mm.

Furthermore, in this embodiment, as shown in FIG. 6, the distal end side portion of the fixed tube 8, specifically, the distal end side fixed tube 81 is provided with a reinforcing layer 85 over substantially the entire portion. 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. Furthermore, as shown in FIG. 6, it is preferable that a reinforcing layer does not exist in a portion that becomes a connection portion with the proximal end side fixing tube 82.
A tubular fixing member 83 that houses the proximal end portion is provided at the proximal end portion of the distal end side tube 2, and a tubular fixing member 84 is disposed at the distal end of the proximal end side tube 9. Yes. As shown in FIGS. 6 and 9, the cylindrical fixing member 83 and the cylindrical fixing member 84 are fixed to the proximal end side fixing tube 82.

  As shown in FIGS. 2 and 3, the living organ dilator 1 includes a plurality of (specifically, two) pulling wires 6a and 6b, and the pulling wires 6a and 6b are described above. 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 tubular member 5. The pulling wires 6a and 6b and the fixing points 69a and 69b are separated by a predetermined length.

Stent-containing tubular member 5 (cylindrical member main body 51, proximal end tubular portion 52), slide tube 7 (slide tube main body 71), fixed tube 8 (distal end fixed tube 81, proximal end fixed tube 82) In consideration of the physical properties (flexibility, hardness, strength, slipperiness, kink resistance, stretchability) required for the cylindrical member for housing the stent, for example, polyethylene, polypropylene, nylon, polyethylene terephthalate , PEEK, polyimide, PTFE, ETFE and other fluorine-based polymers, and thermoplastic elastomers are preferred. The thermoplastic elastomer is appropriately selected from nylon (for example, polyamide elastomer), urethane (for example, polyurethane elastomer), polyester (for example, polyethylene terephthalate elastomer), and olefin (for example, polyethylene elastomer, polypropylene elastomer). Is done.
Furthermore, it is preferable that the outer surface of the stent-accommodating tubular member 5 is subjected to a treatment for exhibiting lubricity. Examples of such treatment include coating or fixing a hydrophilic polymer such as polyhydroxyethyl methacrylate, polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone. The method of doing is mentioned. Moreover, in order to make the slidability of a stent favorable, the above-mentioned thing may be coated or fixed to the inner surface of the cylindrical member 5 for stent accommodation.
The cylindrical member 5 for accommodating a stent may be formed of a combination of the two-layered polymers described above (for example, the outer surface is nylon and the inner surface is PTFE).

The living organ dilator 1 is fixed at one end to the proximal end of the stent housing tubular member 5, passes through the slide tube 7 and the stationary tube 8, beyond the proximal end of the stent housing tubular member 5. The traction wire 6 extends through the proximal tube 9. Then, by pulling the pulling wire 6 toward the proximal end side of the proximal end side tube, the stent housing tubular member 5 and the slide tube 7 move toward the proximal end side.
As shown in FIG. 1 to FIG. 5 and FIG. 7 to FIG. 12, this living organ dilator 1 includes a plurality of (specifically, two) pulling wires 6a and 6b, and the pulling wire 6a. , 6b is fixed to the proximal end portion of the stent-containing tubular member 5 by fixing points 69a, 69b 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, as shown in FIG. 10 and as described above, the pulling wires 6a and 6b are fixed to the inner surface of the ring-shaped member 75 included in the slide tube 7 by fixing points 75a and 75b. Therefore, in the living organ dilator 1 of this embodiment, the pulling wires 6 a and 6 b are pulled toward the proximal end, whereby the ring-shaped member 75 is also pulled toward the proximal end, and slides on the ring-shaped member 75. When the tube 7 (slide tube main body 71) contacts, the slide tube is also pulled to the proximal 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 points 75a and 75b of the ring-shaped member 75, the pulling wires 6a and 6b and the stent at the fixing points 69a and 69b. The fixing between the storage tubular members 5 is surely prevented.

In the living organ dilator 1 of this embodiment, as shown in FIG. 1, the pulling wire 6 penetrates the proximal end side tube 9 and extends from the proximal end of the proximal end side tube.
As a constituent material of the pulling wire, a wire or a twist of a plurality of wires can be suitably used. Moreover, although the wire diameter of a pulling wire is not specifically limited, Usually, about 0.01-0.55 mm is preferable and about 0.1-0.3 mm is more preferable.
The pulling wire 6 may be formed of a stainless steel wire (preferably high-strength stainless steel for springs), a piano wire (preferably a nickel-plated or chrome-plated piano wire), or a superelastic alloy wire. , Ni-Ti alloy, Cu-Zn alloy, Ni-Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, wire rods formed of various metals such as tantalum, polyamide, polyimide, ultra high molecular weight polyethylene, Examples thereof include relatively high-rigidity polymer materials such as polypropylene and fluororesin, and combinations of these appropriately.
Moreover, you may coat | cover the low-friction resin which increases lubricity on the side 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 resins may be used.

  Furthermore, in the living organ dilator 1 of this embodiment, a rigidity imparting body 11 is provided separately from the above-described pulling wire. As shown in FIGS. 1 to 3, 5, 6, and 9, the rigidity imparting body 11 extends from the proximal end side of the living organ dilating instrument 1, passes through the proximal end side tube 9, and is further fixed. 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. 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. 5, 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 living organ dilator 1 of this embodiment, as shown in FIG. 6, the rigidity imparting body 11 is also fixed to a cylindrical fixing member 84 that is fixed to the fixing tube 8. As shown in FIG. 6, the cylindrical fixing member 84 is formed with a rigidity imparting body fixing portion 84a extending in 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 base end part of the base end side tube 9, or the operation part 10 mentioned later by the base end part. By providing such a rigidity imparting body 11, it is possible to suppress deformation of the living organ dilator at the time of traction of the traction member (traction wire). Further, the distal end portion 11 a 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 wavy portion may be formed on the side surface to provide a retaining member from the fixing member.

As the rigidity imparting body 11, a wire or a twist of a plurality of wires can be suitably used. Moreover, although the thickness of the rigidity imparting body 11 is not specifically limited, Usually, about 0.01-1.5 mm is preferable and about 0.1-1.0 mm is more preferable.
Further, as the rigidity imparting body 11, the main body side portion (specifically, the portion in the proximal end side tube) has high rigidity (for example, the wire diameter is thick), and the distal end side portion has low rigidity (specifically The wire diameter is preferably small. 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, a stainless steel wire (preferably, high-strength stainless steel for spring), a piano wire (preferably a piano wire plated with nickel or chrome), or a superelastic alloy is used. Examples thereof include wires formed of various metals such as wires, 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).

A first stent 3 and a second stent 4 are housed in the stent housing tubular member 5.
The stents 3 and 4 are formed in a substantially cylindrical shape, compressed in the direction of the central axis when inserted into the living body, and expanded outwardly when placed in the living body (so-called self-expanding stents). ) As long as it is anything.
The first stent 3 and the second stent 4 may have different outer diameters when restored to a shape before compression (expanded or uncompressed). Specifically, it is preferable that the first stent 3 is smaller in outer diameter when not compressed than the second stent 4. Usually, a blood vessel into which a living organ dilator is inserted has a smaller blood vessel diameter in the insertion direction (traveling direction). For this reason, by making the first stent 3 positioned on the distal end side of the living organ dilator a small diameter, it is possible to cope with the expansion of a small blood vessel site, and the second stent is the first stent. By having a larger diameter (larger diameter) than one stent, it is possible to cope with blood vessels that are thicker than the first stent placement site, and to improve blood vessels with different diameters using one living organ dilator. It can be carried out.
And as an outer diameter at the time of the non-compression of a 1st stent, 2-10 mm is preferable, and 3-8 mm is especially preferable. The length of the first stent is 10 to 120 mm, more preferably 20 to 100 mm. The outer diameter of the second stent when not compressed is preferably 4 to 12 mm, and particularly preferably 5 to 10 mm. The length of the second stent is 10 to 120 mm, more preferably 20 to 100 mm.
As described above, when the outer diameter at the time of non-compression is smaller in the first stent 3 than in the second stent, the difference in the outer diameter at the time of non-compression is 1 to 5 mm. It is preferable that
As the form of the stents 3 and 4, for example, those having a shape as shown in FIG. 20 (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 30, an opening 34 defined by the frames 36 a and 36 b constituting the cylindrical frame body 30, and a notch 35 defined by the frame 36 a. The frame body 30 has both end portions 33a and 33b.

  A synthetic resin or a metal is used as a material for forming the stent. As the synthetic resin, those having a certain degree of hardness and elasticity are used, and a biocompatible synthetic resin is preferable. Specifically, polyolefin (for example, polyethylene, polypropylene), polyester (for example, polyethylene terephthalate), fluororesin (for example, PTFE, ETFE), or polylactic acid, polyglycolic acid, or polylactic acid that is a bioabsorbable material For example, a copolymer of polyglycolic acid. In addition, a metal having biocompatibility is preferable, and examples thereof include stainless steel, tantalum, and nickel titanium alloy. In particular, a super elastic metal is preferable. It is preferable that the stent 3 is integrally formed without forming a sudden change point of physical properties as a whole. For example, a stent is prepared by preparing a metal pipe having an outer diameter suitable for an in-vivo site to be placed, and a side surface of the metal pipe is partially cut by cutting (for example, mechanical cutting, laser cutting), chemical etching, or the like. It is produced by removing and forming a plurality of notches or a plurality of openings on the side surface.

Since the stent 3 has the cutout portion 35 at the end of the frame body 30, 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. An opening 34 surrounded 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 stent 3 can be easily deformed at the center (the center of the frame body 30). Note that the cutouts and openings are not limited to the shape and number shown in the figure, and 3 to 10 cutouts and about 3 to 10 openings are suitable.
The frame body 30 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 300 mm. More preferably, it is 15-200 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 stents 3 and 4 is not limited to the above-described shape as long as it can be reduced in diameter when inserted and can be expanded (restored) when released into the 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.

  As the superelastic metal forming the stent, a superelastic alloy is preferably used. The superelastic alloy here is generally called a shape memory alloy, and exhibits superelasticity at least at a living body temperature (around 37 ° C.). Particularly preferably, a Ti—Ni alloy of 49 to 53 atomic% Ni, a Cu—Zn alloy of 38.5 to 41.5 wt% Zn, and a Cu—Zn—X alloy of 1 to 10 wt% X (X = Be, A super elastic metal body such as Si, Sn, Al, Ga), Ni-Al alloy of 36-38 atomic% Al is preferably used. Particularly preferred is the Ti—Ni alloy described above. Further, a Ti—Ni—X alloy in which a part of the Ti—Ni alloy is substituted with 0.01 to 10.0% X (X = Co, Fe, Mn, Cr, V, Al, Nb, W, B, etc.) Or a Ti—Ni—X alloy (X = Cu, Pb, Zr) in which a part of the Ti—Ni alloy is substituted by 0.01 to 30.0% atoms, and the cold work rate Alternatively, mechanical properties can be appropriately changed by selecting conditions for the final heat treatment. 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.
The stent used in the living organ dilating instrument of the present invention includes a stent body that is formed in a substantially cylindrical shape and that can be reduced in diameter, and a cylindrical cover (not shown) that seals the side surface of the stent body. There may be.

  In all of the above-described embodiments, the living body expansion device 20 shown in FIG. 13 may be used. In the living organ dilator 20 of this embodiment, even if the reinforcing portion 43a that reinforces the first proximal direction movement restraining portion 31 portion penetrates into the second distal direction movement restraining portion 42. Good. By doing in this way, a reinforcement part non-existence part is not formed between the 1st base end direction movement suppression part 31 and the 2nd front end direction movement suppression part 42, and the kink in this area | region is ensured more To prevent.

  Further, in all the embodiments described above, the living body expansion device 30 shown in FIG. 14 may be used. In the living organ dilator 30 of this embodiment, a contrast portion 54 (X-ray contrast portion or ultrasonic contrast portion) is provided at or near the distal end of the stent housing tubular member 5. The contrast portion 54 is preferably formed by embedding a contrast member in the outer surface of the stent-accommodating tubular member 5. As the X-ray contrast material forming the contrast portion, for example, gold, platinum, platinum-iridium alloy, silver, stainless steel, platinum, or an alloy thereof is preferable. The contrast member is attached by forming a wire with an X-ray contrast material and winding it around the outer surface of the distal tube, or forming or bonding a pipe with the X-ray contrast material.

Furthermore, in all the above-described embodiments, it may be similar to the living organ dilator 40 shown in FIG. In the living organ dilator 40 of this embodiment, the central portion of the stent housing tubular member 5, specifically, the central portion of the tubular member main body 51 is a flexible portion compared to other portions. . More specifically, the central portion of the stent housing tubular member 5 between the first stent housing portion and the second stent housing portion is a flexible portion. Specifically, the cylindrical member main body 51, which is a flexible portion, is a thin portion with a reduced outer diameter, and a covering member 55 formed of a flexible material is provided on the outer surface thereof. It has been. For this reason, in the living organ dilator 40, the space between the first stent housing and the second stent housing is more flexible than the first stent housing and the second stent housing. Since it permits, the operativity of the front-end | tip part of a biological organ expansion instrument improves. Further, as the cylindrical member main body 51, the inner diameter and the outer diameter of the flexible portion are substantially the same as other portions, and there is no step portion on the inner surface, and the stent is stored due to the flexible portion. There is no obstacle when the tubular member 5 is moved.
As a material for forming a flexible covering member, nylon (for example, polyamide elastomer), urethane (for example, polyurethane elastomer), polyester (for example, polyethylene terephthalate elastomer), olefin (for example, polyethylene elastomer, polypropylene elastomer) ), Silicone rubber, etc. can be used.
Furthermore, in all the above-described embodiments, it may be a living organ dilator 60 shown in FIG. In the living organ dilator 60 of this embodiment, the first base end direction movement restraining part and the second distal direction movement restraining part are the movement restriction 31a. And also in this movement restriction | limiting 31a, the base end part is a taper shape.

Further, in all of the above-described embodiments, the living body expansion device 100 shown in FIG. 17 may be used.
In the living organ dilator of the embodiment described above, the fixed tube 8 is a type in which the slide tube 7 is housed from the proximal end side during pulling, in other words, the slide tube main body 71 of the slide tube 7 is fixed from the proximal end. It is of the type that enters the tube 8.
On the other hand, in the living organ dilator 100 of this embodiment, the type in which the slide tube 7 fits the fixed tube 8 from the proximal end side, that is, the slide tube main body 71b of the slide tube 7 at the time of towing, The distal end side fixed tube 81c of the fixed tube 8 is encapsulated from the base end.
For this reason, the inner diameter of the slide tube main body 71b is substantially equal to or slightly larger than the outer diameter of the distal end side fixed tube 81c of the fixed tube 8. The distal end side fixed tube 81c is fixed to the distal end portion of the proximal end side fixed tube 82 at the proximal end portion thereof by a fixing portion 81b. In this embodiment, the member 24 does not function as a slide tube locking portion.
Further, in all of the above-described embodiments, the second organ-direction movement restraint unit may not be provided like the living organ dilator 110 shown in FIG. In this case, the tubular main body preferably includes a reinforcing portion 43 that reaches from the first proximal direction movement suppressing portion 31 to the vicinity of the distal end portion of the second stent 4 or in the distal end portion. In particular, it is preferable that the end portion of the reinforcing portion 43 reaches the distal end portion of the second stent 4.

Furthermore, in all the embodiments described above, the living body expansion device 120 shown in FIG. 19 may be used.
FIG. 19 is an enlarged cross-sectional view of the vicinity of a proximal end portion of a stent housing tubular member of a living organ dilating instrument according to another embodiment of the present invention.
In the living organ dilator 120 of this embodiment, as shown in FIG. 19, the slide tube 7 is fixed to the slide tube body 71 and the distal end portion of the slide tube body 71, covers the distal end of the slide tube body 71, and A distal end-side cylindrical member 170 extending from the distal end of the slide tube main body 71 to the distal end side of the living organ dilator 120. And the front end side cylindrical member 170 is an integrally formed cylindrical body having a reduced diameter portion 171 located between the front end and the base end of the front end side cylindrical member 170 and having a reduced inner diameter. In this embodiment, the inner diameter of the reduced diameter portion 171 is substantially equal to, slightly larger or slightly smaller than the inner diameter of the slide tube main body 71. Further, in the living organ dilator 120 of this embodiment, as shown in FIG. 19, the distal side tubular member 170 has at least the outer diameter and the inner diameter of the portion other than the reduced diameter portion 171 larger than the slide tube main body 71. It has become. The reduced diameter portion 171 is located between the distal end and the proximal end of the distal end side tubular member 170, specifically, slightly proximally from the distal end.
The inner diameter of the reduced diameter portion 171 of the distal end side tubular member 170 is larger than the outer diameter of the distal end side tube 2. For this reason, the distal end side cylindrical member 170 can move to the proximal end side without contacting the distal end side tube 2.
A resin ring 176 is disposed between the distal ends of the slide tube main body 71. The resin ring 176 prevents the adhesive forming the fixing portion 77 from flowing into the distal end side tubular member 170. As a resin ring, a thing with little frictional resistance is preferable. As the resin ring, fluorine polymers such as ETFE, PEEK (polyetheretherketone), polyimide and the like can be suitably used.
The living organ dilator 120 in this embodiment includes a ring-shaped member 180 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 180. It is fixed to.
The ring-shaped member 180 is filled between the plastic outer cylinder member 181, the plastic outer cylinder member 182 inserted into the plastic outer cylinder member 181, and the plastic outer cylinder member 181 and the plastic outer cylinder member 182. The adhesive 183 is used. The pulling wires 6 a and 6 b penetrate between the plastic outer cylinder member 181 and the plastic outer cylinder member 182 and are fixed to the ring-shaped member 180 by an adhesive 183. As the plastic outer cylinder member 181 and the plastic outer cylinder member 182, those having low frictional resistance are preferable. As the resin ring, fluorine polymers such as ETFE, PEEK (polyetheretherketone), polyimide and the like can be suitably used.

The living organ dilator 1 according to the present invention includes an operation unit 10 fixed to the proximal end of the proximal tube 9 as shown in FIGS. 1 and 21 to 25.
FIG. 21 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to the present invention. FIG. 22 is an enlarged rear view of the vicinity of the operation unit of the biological organ dilator shown in FIG. FIG. 23 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG. FIG. 24 is a right side view of only the operation portion of the living organ dilator shown in FIG. FIG. 25 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG.
In addition to the pulling wire winding mechanism, the operating unit 10 in the living organ dilator 1 of this embodiment includes a lock mechanism that locks the rotation of the pulling wire winding mechanism so as to be releasable, and winding of the pulling wire with a pulling wire winding function. A reverse rotation restricting mechanism for restricting rotation in the direction opposite to the taking 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 is bent and rounded at the base end side and the central portion, and is easy to grip and allows easy operation of the roller in the gripped state.
And as shown in FIG. 23, the front-end | tip part of the cylindrical connector 45 is being fixed to the base end of the base end side tube 9. As shown in FIG. Further, a sealing mechanism connected to the proximal end portion of the connector 45 is accommodated in the operation portion housing 50. As shown in FIG. 23, the sealing mechanism includes a cylindrical main body member 70 having a distal end portion fixed to the rear end portion of the connector 45, and a cap member 70a fixed to the proximal end of the cylindrical 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 base 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. The constituent material of the connector is the same as described above. An elastic material is used as a constituent material of the seal member. The elastic material is the same as described above. An elastic material is used as a constituent material of the seal member 70b. The elastic material is the same as described above.

  As shown in FIGS. 21 to 24, 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. 21 and 22, the bearing portions 94a and 94b are bowl-shaped members that house one end 64b and the other end 64a 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 portion 10 of this embodiment, the bearing portions 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 stored in the other end side space of the bearing portions 94a and 94b. The state shown in FIG. 23 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 are in contact with 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. 22 and 25, the operation unit 10 includes a collar member 12. The collar member 12 has a collar portion 14 that accommodates the take-up shaft portion 63 and forms an annular space with the take-up 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 the 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. 21 and 22, the bearing portions 94a and 94b are formed in a gentle arc shape centered on the pin 13 (bearing portions 59 and 158), and the roller 61 is used for locking. It has the length which can move the distance more than the height of a rib. Further, as shown in FIG. 25, 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 notch 15 and is fixed to the winding shaft 63.

  The pulling wire winding mechanism is composed of a roller 61 and a winding shaft portion 63 that rotates by the rotation of the roller 61. The winding shaft portion 63 holds or fixes the proximal end portion of the pulling wire 6. Specifically, as shown in FIG. 22, the proximal end portion of the pulling wire 6 is provided with an anchor portion 65 formed larger than the wire 6, and the winding shaft portion 63 accommodates the pulling wire 6. A possible slit 63a is provided. And the base end part of the pulling wire 6 is accommodated in the slit 63a of the winding shaft part 63 so that the anchor part 65 is located outside the base 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, you may fix the base end or base end part of the pull wire 6 to a winding shaft directly.

Moreover, it is preferable that the base 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 proximal end portion of the pulling wire 6 is formed of a flexible material, a method in which the proximal 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 FIGS. 21, 23, and 24, the winding shaft portion 63 is provided on one side surface 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, it is possible to take up slowly, and the movement of the stent-accommodating tubular member toward the proximal end 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. Moreover, as an outer diameter of a rotating roller, about 10-60 mm is suitable, and 15-50 mm is especially preferable.
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 of this embodiment includes a lock mechanism that locks the rotation of the pulling wire winding mechanism so as to be releasable, and reverse rotation that restricts rotation of the pulling wire winding function in the direction opposite to the winding direction of the pulling wire. A regulation mechanism is provided.
As shown in FIGS. 21 to 23, the operation rotating roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Furthermore, as shown in FIGS. 22 and 24, 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, in the housing 50, an urging means (urging member) 80 for urging the rotating roller 61 in the direction of the opening of the housing is provided. 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. 22, 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, the reverse rotation restricting mechanism for restricting the rotation of the pulling wire winding function in the direction opposite to the winding direction of the pulling wire by the biasing means 80 and the gear portion 62 described above is provided. It is configured.
As shown in FIGS. 21 to 24, the operation rotation roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Further, as shown in FIG. 24, the gear portion 62 is provided on the surface opposite to the surface on which the winding shaft portion 63 of the rotating roller 61 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.
As shown in FIGS. 21 to 23, 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, although it is possible to rotate in the direction of the arrow in FIG. 23 (direction in which the pulling wire is wound), if 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 function. In the operation unit 10, as shown in FIG. 24, the reverse rotation regulating 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 part 62 has a smaller diameter than the rotating roller. The outer diameter of the gear part 62 is preferably about 10 to 60 mm, particularly preferably 15 to 50 mm, and the number of teeth is 4 to 200. A degree is suitable and 4-70 is especially preferable.
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, a method for using the living organ dilator 1 of the present invention will be described with reference to the drawings.
First, in many cases, the end of a guide wire already placed in the body is inserted into the opening 25a of the tip member of the living organ dilator shown in FIGS. 1 and 2, and the guide wire (not shown) is inserted through the opening 23. ). Next, it is inserted into a guiding catheter (not shown) inserted in the living body, the living organ dilator 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 61 is rotated in the direction of the arrow in FIG. Thereby, the pulling wire 6 is wound around the outer peripheral surface of the winding shaft 63, and the stent-accommodating tubular member 5 and the slide tube 7 move to the proximal end side in the axial direction. At this time, since the rear end surface of the first stent 3 is brought into contact with and locked to the distal end surface of the first proximal direction movement restraining portion 31, the stent storage tubular member 5 is moved along with the movement of the stent storage tubular member 5. It is discharged from the tip opening of the cylindrical member 5. By this release, as shown in FIG. 11, the first stent 3 is self-expanded to expand the stenosis part and is placed in the stenosis part.
Then, the living body organ dilator 1 is operated using the first proximal direction movement suppression unit 31 and the second proximal direction movement suppression unit 41 having contrast properties as indices, and the first proximal direction movement suppression unit 31 is operated. And between the 2nd proximal direction movement suppression parts 41, ie, the 2nd stent 4, is arrange | positioned in the target indwelling site | part. Then, after pressing the operation rotating roller 61 of the operation unit 10, the roller is rotated in the direction of the arrow in FIG. Thereby, the pulling wire 6 is wound around the outer peripheral surface of the winding shaft 63, and the stent-accommodating tubular member 5 and the slide tube 7 move to the proximal end side in the axial direction. At this time, since the rear end surface of the second stent 4 is brought into contact with and locked with the distal end surface of the second proximal direction movement restraining portion 41, the stent storage tubular member 5 is moved along with the movement of the stent storage tubular member 5. It is discharged from the tip opening of the cylindrical member 5. By this release, as shown in FIG. 12, the second stent 4 is self-expanded to expand the stenosis part and is placed in the stenosis part.

DESCRIPTION OF SYMBOLS 1 Living organ dilator 2 Front end side tube 3 1st stent 4 2nd stent 5 Tubular member 6 for stent accommodation Pulling member 10 Operation part 31 1st proximal direction movement suppression part 32 1st distal direction movement suppression Part 41 Second proximal direction movement restraining part 42 Second distal direction movement restraining part

Claims (17)

First and second stents that are formed in a substantially cylindrical shape, are compressed in the direction of the central axis when inserted into a living body, and expand outward when placed in the living body, a tubular body having a guide wire lumen, and the first body And a cylindrical member for accommodating a stent in which the second stent is accommodated in the distal end portion, and the first and second stents are arranged so as to cover the distal end portion of the tubular main body, and are used for accommodating the stent. A biological organ dilator that can expose the first and second stents by moving a tubular member proximally relative to the tubular body;
The second stent is disposed at a proximal end side of a predetermined length from the first stent, and the biological organ dilating instrument is close to or abuts on the rear end of the first stent and has a contrast property. 1. A living organ expansion comprising: 1 proximal direction movement suppression unit; and a second proximal direction movement suppression unit that is close to or in contact with the rear end of the second stent and has contrast properties Instruments. The said tubular main body is located in the front end side of this tubular main body, The distal direction movement suppression part for 1st stents which adjoins or contacts the front-end | tip of a said 1st stent is provided. Biological organ dilator. The tube-shaped main body is provided with a distal-direction movement restraining portion for a second stent that is located on the distal end side of the tubular main body and is close to or in contact with the distal end of the second stent. The biological organ dilator described. The living organ expansion instrument according to any one of claims 1 to 3, wherein the tubular main body includes a reinforcing portion extending in a proximal direction toward a predetermined length from the first proximal direction movement restraining portion. 5. The living organ dilator according to claim 1, wherein the tubular main body includes a reinforcing portion extending in a proximal direction toward a predetermined length from the second proximal direction movement suppressing portion. The living body according to any one of claims 3 to 5, wherein the tubular main body includes a reinforcing portion that reaches the vicinity of the distal end portion of the second stent or the distal end portion from the first proximal direction movement restraining portion. Organ dilator. 7. The rear end portion of the first proximal direction movement restraining portion and / or the second proximal direction movement restraining portion is a tapered portion having a diameter reduced toward the proximal direction. The living organ dilator according to any one of the above. The living organ dilator according to any one of claims 1 to 7, wherein a distal end portion of the stent-accommodating tubular member has a contrast property. The living organ expansion according to any one of claims 1 to 8, wherein the stent-housing tubular member has a flexible portion between a portion for housing the first stent and a portion for housing the second stent. Instruments. The living organ expansion device according to claim 1, wherein the first stent and the second stent have different outer diameters when expanded. The tubular body includes a distal end side tube having a guide wire lumen, a proximal end side tube, a proximal end portion of the distal end side tube, and a distal end portion of the proximal end side tube, and communicates with the guide wire lumen. The living organ dilator according to any one of claims 1 to 10, further comprising a fixed tube having an opening to be opened. The biological organ dilator has one end fixed to the stent-housing tubular member, extends in the tube-like main body, and pulls toward the proximal end side of the tube-like main body. The biological organ dilating instrument according to any one of claims 1 to 11, further comprising at least one pulling wire for moving the to the proximal end side. The living organ expansion according to claim 12, wherein the tubular main body has an operation unit including a pulling wire winding mechanism for winding the pulling wire and moving the stent-accommodating tubular member to the proximal end side. Instruments. The biological organ dilating instrument according to any one of claims 11 to 13, further comprising a linear rigidity imparting body that passes through the proximal tube and enters the fixed tube. 15. The living organ dilator according to claim 14, wherein the operation unit includes a lock mechanism that releasably locks the rotation of the pulling wire winding mechanism. The living organ dilator according to claim 14 or 15, wherein the operation unit includes a reverse rotation restricting mechanism for restricting rotation of the pulling wire winding function in a direction opposite to a winding direction of the pulling wire. The pulling wire winding mechanism is provided with an operation rotating roller and a winding shaft portion coaxially and integrally with the operation rotating roller and having a smaller diameter than the operation rotating roller, and the winding shaft portion The living organ dilator according to any one of claims 14 to 16, wherein a proximal end portion of the pulling wire is fixed to the body.

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