JP2008272261A - Body organ expansion instrument - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a body organ expansion instrument using a self-expanding stent applying very little twisting force to the stent stored in a stent storage cylindrical member by inhibiting the twisting force applied to the proximal end while the instrument is being inserted into a living body from being transmitted to the stent storage cylindrical member. <P>SOLUTION: The body organ expansion instrument 1 comprises a distal end tube 2, a proximal end tube 4, a sliding tube 7 disposed close to the proximal end of the stent storage cylindrical member 5, a fixed tube 8 to which the distal end tube 2 and the proximal end tube 4 are fixed and which can store the sliding tube 7, and traction wires 6a and 6b for moving the cylindrical member 5 to the proximal end side. The sliding tube 7 is movable to the proximal end side by the taction of the traction wires 6a and 6b, and is not fixed to the stent storage cylindrical member 5. <P>COPYRIGHT: (C)2009,JPO&INPIT

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 blockage of a body lumen or body lumen such as blood vessels, bile ducts, esophagus, trachea, urethra, digestive tract, and other organs Has been proposed.
Examples of the stent constituting the living organ dilator include a balloon expandable stent and a self-expandable stent depending on the function and the indwelling 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.

  However, self-expanding stents are generally said to be more difficult to place accurately than balloon expandable stents. The reason is that after the stent is placed in the target stenosis, only the liquid is injected into the balloon, so that the stent does not move back and forth when the stent is expanded. On the other hand, the structure of the delivery system for self-expanding stents is that the stent is accommodated and restrained between the inner tube and the outer tube, and a locking portion for restricting the movement of the stent is provided on the stent proximal end side of the inner tube. By pulling the tube proximally, the stent is released and self-expanded. At this time, slack in the body cavity of the outer tube, friction between the outer tube and the catheter introducing the body cavity or the outer tube, friction with a valve of a device called an introducer for introducing the system into the body, etc. Because of this, it is said that the stent is easy to advance when it expands.

Therefore, the applicant of the present application has proposed the one disclosed in Patent Document 1 (Japanese Patent Laid-Open No. 2007-97620).
The living organ dilator 1 encapsulates a distal end tube 2 having a guide wire lumen 21, a proximal end tube 4 fixed to the proximal end of the distal end tube 2, and a distal end side of the distal end tube 2. A stent housing tubular member 5 slidable in the proximal direction; a stent 3 housed in the tubular member 5; and a puller wire 6 for moving the tubular member 5 to the proximal side. Prepare. The distal side tube 2 includes a proximal side opening 23 that opens on the proximal side of the distal side tube 2, a stent locking portion 22 that restricts movement of the stent to the proximal side, a pulling wire winding mechanism, and a wire It has an operation part provided with a winding amount control mechanism.
Furthermore, this living organ dilator 1 encapsulates the proximal end side of the distal end tube 2 and the proximal end side of the stent housing tubular member 5, and the proximal end portion and the proximal end portion of the distal end side tube 2 at the proximal end portion. An intermediate tube 7 fixed to the distal end portion of the end side tube 4 is provided. The intermediate tube 7 encapsulates the stent housing tubular member 5 without restricting the movement of the stent housing tubular member 5 toward the proximal end, and one end of the pulling wire 6 is formed in the intermediate tube 7 within the tubular tube for stent storage. The pulling wire 6 is fixed to the member 5 and extends between the intermediate tube 7 and the distal end side tube 2 and into the proximal end side tube 4.

  And even if this living organ expanding device is a living organ expanding device using a self-expanding stent, the proximal opening is not the proximal end of the device but the proximal end of the distal tube, so that the stent placement operation In some cases, it is easy to replace with another living organ dilator. Since the stent can be released by pulling the pulling wire to the proximal end side, the movement of the stent position during the stent discharging operation is extremely small. Furthermore, there is an advantage that unnecessary bending and damage of the catheter due to excessive winding of the wire that pulls the restraint body of the stent to the proximal end side are not generated.

JP 2007-97620 A

Although the thing of patent document 1 is also effective enough, when inserting into a living body, a living body expansion device may perform an insertion operation | work by giving a twist (torque) by the base end side. The torsion applied to the proximal end side may be transmitted to the stent housing tubular member via the distal end portion of the intermediate tube, and the torsion applied to the stent housing tubular member The stent accommodated in the state of pressing is also twisted. The present inventors have found that it is desirable not to impart such a twist to the stent.
Accordingly, an object of the present invention is a living organ dilator using a self-expanding stent, the outer tube for releasing the stent can be easily moved, and the stent placement operation can be easily and reliably performed. The transmission of the twisting force applied at the proximal end during insertion into the living body to the tubular member for stent storage is suppressed, and the torsional force is applied to the stent stored in the tubular member for stent storage. Therefore, the present invention provides a living organ dilator with very little.

What achieves the above object is as follows.
(1) 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 an opening communicating with the guide wire lumen are provided. A fixed tube provided, a stent storage tubular member that encloses the distal end side of the distal end tube and is slidable in the proximal direction of the distal end tube, and is accommodated in the stent storage tubular member One end of the stent is fixed to the stent-housing tubular member, extends in the proximal end tube, and is pulled toward the proximal end of the proximal end tube. A living organ dilator comprising at least one puller wire for movement proximally,
The distal end tube is positioned on the distal end side of the distal end side tube, contacts the proximal end of the stent housed in the stent housing tubular member, and restricts movement of the stent toward the proximal end side. A stent proximal end locking portion, wherein the stent is formed in a substantially cylindrical shape, and is stored in the stent storage tubular member in a compressed state in the central axis direction. At the time of discharge from the cylindrical member for use, it expands outward to restore the shape before compression,
The living organ dilator includes a slide tube arranged so as to be close to a proximal end of the stent housing tubular member, and the fixed tube can store the slide tube from the proximal end side or the slide The tube can be fitted from the base end side, and the slide tube can be moved to the base end side together with the stent storage tubular member by pulling the pull wire, and the stent storage tubular member Unfixed living organ dilator.

(2) The cylindrical member for storing a stent includes a small diameter portion provided at a proximal end portion, and the slide tube encapsulates the proximal end portion of the small diameter portion of the cylindrical member for stent storing. The living organ dilator described in (1) above.
(3) The tubular member for accommodating a stent includes a small diameter portion provided at a proximal end portion, and a distal end portion of the pulling wire is fixed on an outer surface of the small diameter portion. The living organ dilator described in the above.
(4) The biological organ dilating instrument according to (2) or (3), wherein the stent-housing tubular member includes a tubular portion that encloses the small-diameter portion.
(5) The cylindrical member for storing a stent includes a small-diameter portion provided at a proximal end portion, and a distal end portion of the pulling wire is fixed by a metal ring body attached to an outer surface of the small-diameter portion. (1) The biological organ dilator according to any one of (4).

(6) The living organ dilator according to any one of (1) to (5), wherein the pulling wire is fixed to an inner surface of the slide tube or a member that moves by pulling the pulling wire.
(7) The slide tube is capable of storing the slide tube from the proximal end side, and the distal end side tube is located in the fixed tube so that the proximal end of the slide tube can come into contact therewith. The living organ dilator according to any one of the above (1) to (6), comprising a locking portion.
(8) The living organ dilator includes a linear rigidity imparting body that passes through the proximal end side tube and enters the fixed tube, and a distal end portion of the linear rigidity imparting body is engaged with the slide tube. The biological organ dilator according to (7), which is fixed to a part.
(9) The biological organ dilator according to (7) or (8), wherein the fixing tube includes a rigidity imparting body fixing portion provided on a proximal end side with respect to the slide tube locking portion.

(10) The operation unit including a pulling wire winding mechanism that winds the pulling wire and moves the stent-accommodating tubular member to the proximal end side at a proximal end portion of the proximal tube. (1) The living organ dilator according to any one of (9).
(11) The operation unit includes an operation unit housing, and the pulling wire winding mechanism includes an operation rotating roller having a portion exposed from the operation unit housing, and the rotating wire is rotated to rotate the pulling wire. The living organ dilator as set forth in (10), which is wound up at the proximal end side.
(12) The biological organ dilator according to (10) or (11), wherein the operation unit includes a lock mechanism that releasably locks the rotation of the pulling wire winding mechanism.
(13) Any of the above (10) to (12), wherein the operation unit includes a reverse rotation restricting mechanism that restricts rotation of the pulling wire winding function in a direction opposite to the winding direction of the pulling wire. The living organ dilator described in 1.
(14) 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. The living organ dilator according to any one of (10) to (13), wherein the proximal end portion of the pulling wire is fixed to the take-off shaft portion.

The biological organ dilator according to the present invention includes a distal tube having a guide wire lumen, a proximal tube, a proximal tube of the distal tube, a fixed tube to which the distal tube is fixed, and a distal tube A tubular member for housing a stent that encloses the distal end side of the tube and is slidable in the proximal direction of the distal tube, a stent housed in the tubular member for housing the stent, and a tubular member for stent housing And a pulling wire for moving the stent housing tubular member to the proximal side by pulling to the proximal side of the proximal tube while extending in the proximal tube. Further, the slide tube is arranged so as to be close to the proximal end of the stent-accommodating cylindrical member, and the fixed tube can accommodate the slide tube from the proximal end side or the slide tube. The slide tube can be fitted from the proximal end side, and can be moved to the proximal end side together with the stent housing tubular member by pulling the pulling wire, and is not fixed to the stent housing tubular member. Yes.
For this reason, even if the torsional force applied at the proximal end portion of the living organ dilator is transmitted to the slide tube, it is very rarely transmitted to the stent housing tubular member. The torsional force is hardly applied to the stent housed in the member. Also, in this biological organ dilator, the stent-housing tubular member is less deformed when pulled by the pulling wire, the stent-housing tubular member moves favorably in the proximal direction, and is used for releasing the stent. The movement of the outer tube is facilitated, and the stent placement operation can be performed easily and reliably.

Next, the living organ dilator according to the present invention will be described using examples.
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. 4 is a cross-sectional view taken along line AA in FIG. 5 is an enlarged cross-sectional view taken along line BB in FIG. 6 is an enlarged cross-sectional view taken along the line CC of FIG. 7 is an enlarged cross-sectional view taken along the line DD of FIG. FIG. 8 is an enlarged cross-sectional view of the proximal end portion of the tubular member for housing a stent and the vicinity of the distal end portion of the slide tube of the living organ dilator shown in FIG. FIG. 9 is an enlarged cross-sectional view of the vicinity of the proximal end portion of the fixed tube of the living organ dilator shown in FIG. FIG. 10 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention.

In the living organ dilator 1 of the present invention, the distal end side tube 2 having the guide wire lumen 21, the proximal end side tube 4, the proximal end portion of the distal end side tube 2 and the distal end portion of the proximal end side tube 4 are fixed. In addition, a fixed tube 8 having an opening 23 communicating with the guide wire lumen 21, and a stent housing tubular member 5 that encloses the distal end side of the distal tube 2 and is slidable in the proximal direction of the distal tube 2. And one end of the stent 3 housed in the stent housing tubular member 5 and the stent housing tubular member 5 extending in the proximal tube 4 and on the proximal side of the proximal tube. A pulling wire 6 (6a, 6b) that constitutes a moving means for moving the stent-accommodating tubular member 5 to the proximal end side by pulling is provided.
The distal tube 2 is located on the distal side, abuts against the proximal end of the stent 3 housed in the stent housing tubular member 5, and restricts movement of the stent 3 toward the proximal end. Part locking part 22.

The stent 3 is formed in a substantially cylindrical shape, is stored in the stent-accommodating tubular member 5 in a state compressed in the central axis direction, and expands outward when released from the stent-accommodating tubular member 5. It restores the shape before compression.
The living organ dilator 1 includes a slide tube 7 disposed so as to be close to the proximal end of the stent-accommodating tubular member 5, and the fixed tube 8 can accommodate or slide the slide tube 7 from the proximal end side. The tube 7 can be fitted from the base end side, and the slide tube 7 can be moved to the base end side together with the stent storing tubular member 5 by pulling the pulling wire 6, and the stent storing tubular member 5. It is not fixed to.

Further, in the living organ dilator 1 of this embodiment, the outer diameter of the proximal tube 4 is smaller than the outer diameter of the maximum diameter portion on the distal end side of the proximal tube 4 of the living organ dilator 1. Yes. For this reason, even in a state where the guide wire extending from the opening 23 to the proximal side is along the side surface of the proximal tube, the outer diameter of the maximum diameter portion on the distal side from the proximal tube of the biological organ dilator is about the same. It can be inserted into a small-diameter blood vessel.
In the living organ dilating instrument 1 of this embodiment, the pulling wire 6 is wound around the proximal end portion of the proximal end side tube 4, and the pulling wire for moving the stent housing tubular member 5 to the proximal end side. A winding mechanism is provided.
The living organ dilator 1 of this embodiment includes a distal tube 2, a stent 3, a proximal tube 4, a stent housing tubular member 5, a pulling wire 6, a slide tube 7, a fixed tube 8 and a pulling wire 6. An operation unit 10 having a take-off mechanism is provided. The fixed tube 8 connects the distal end side tube 2 and the proximal end side tube 4 and includes an opening 23 that communicates 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 4, the opening 23 is formed obliquely so as to incline 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 600 mm, preferably 30 to 450 mm.

The distal end member 25 is located on the distal end side of the distal end of the stent-accommodating tubular member 5 and is formed in a tapered shape that gradually decreases in diameter toward the distal end as shown in FIGS. Preferably it is. By 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 relative to the 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. 3 and 4, the distal side tube 2 is provided at a position that is a predetermined distance proximal side from the distal end of the tube 2 in order to restrict movement of the stent 3 toward the proximal side. A stent proximal end locking portion 22 is provided. The locking part 22 is preferably an annular protrusion. The distal end side of the stent proximal end locking portion 22 is a stent accommodation site. The outer diameter of the locking portion 22 is large enough to contact the proximal end of the compressed stent 3. Even if the stent-accommodating tubular member 5 moves to the proximal end side, the stent 3 is maintained in position by the locking portion 22, and is consequently released from the stent-accommodating tubular member 5.

  In the living organ dilating instrument 1 of this embodiment, the distal tube 2 has a predetermined length (approximately the axial length of the stent) from the distal end side of the stent proximal end locking portion 22 as shown in FIGS. 3 and 4. The distal end portion locking portion 26 of the stent is provided at the position. As shown in FIGS. 3 and 4, the stent distal end locking portion 26 is located slightly on the proximal end side from the distal end of the stent housing tubular member 5. The locking portion 26 is preferably an annular protrusion. And between this stent front-end | tip part latching | locking part 26 and the stent base end part latching | locking part 22 is a stent accommodation site | part. The outer diameter of the locking portion 26 is large enough to contact the proximal end of the compressed stent 3. Further, the stent distal end locking portion 26 has a tapered surface whose proximal end surface is reduced in diameter toward the proximal direction. Therefore, when the stent is released, the stent tip end locking portion 26 does not become an obstacle, and the recovery of the living organ dilator 1 after the release of the stent 3 (specifically, inside the guiding catheter or sheath) Storage) becomes easy.

  The outer diameters of the stent proximal end locking part 22 and the stent distal end locking part 26 are preferably 0.8 to 4.0 mm. The stent proximal end locking portion 22 and the stent distal end locking portion 26 are preferably annular projections as shown in the figure, but may be any one that restricts the movement of the stent 3 and can be extruded. One or a plurality of protrusions may be provided integrally with the distal end side tube 2 or as separate members. Further, the stent proximal end locking portion 22 and the stent distal end locking portion 26 may be formed of different members from an X-ray contrast material. Thereby, the position of the stent can be accurately grasped under X-ray imaging, and the procedure becomes easier. As the X-ray contrast material, for example, gold, platinum, platinum-iridium alloy, silver, stainless steel, platinum, or an alloy thereof is preferable. The protrusion 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.

  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 4, the proximal tube 4 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. The distal end portion of the proximal end side tube 4 is joined to the fixed tube 8 by a fixing member 84. The proximal tube 4 includes a pulling wire lumen through which the pulling wire 6 can be inserted.
The proximal tube 4 has a length of 300 mm to 1500 mm, more preferably 1000 to 1300 mm, an outer diameter of 0.5 to 1.5 mm, preferably 0.6 to 1.3 mm, and an inner diameter of It is 0.3 to 1.4 mm, preferably 0.5 to 1.2 mm.
The distance of deviation between the central axis of the proximal tube 4 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. Moreover, as a material for forming the proximal end side tube 4, 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-containing tubular member 5 is a tubular body having a predetermined length as shown in FIGS. 1 to 5 and FIG. The front end and the rear end are open. The distal end opening functions as a discharge port of the stent 3 when the stent 3 is placed in a stenosis in the body cavity. As shown in FIG. 10, the stent 3 is pushed out of the opening of the distal end to release the stress load, thereby expanding and restoring the shape before compression.
The length of the stent-housing tubular member 5 is preferably about 20 mm to 400 mm, and more preferably 30 mm to 300 mm. Moreover, as an outer diameter, about 1.0-4.0 mm is preferable, and 1.5-3.0 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 51a of the cylindrical member main-body part 51 may be enclosed. 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. The outer diameter of the stent housing part is preferably about 1.0 to 4.0 mm, particularly preferably 1.5 to 3.0 mm. Further, the length of the stent-accommodating tubular member 5 is preferably about 20 to 400 mm, and particularly preferably 30 to 300 mm. Further, the length of the cylindrical member main body 51 is preferably about 10 to 200 mm, particularly preferably 15 mm to 150 mm, and the length of the proximal end side cylindrical portion 52 is preferably about 10 to 200 mm. 15 mm to 150 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.

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

  Specifically, as shown in FIGS. 2 to 6 and 7, the slide tube 7 includes a slide tube main body 71 and a distal end side member that is fixed to the distal end and has a larger outer diameter and inner diameter than the slide tube main body 71. I have. In this embodiment, the distal end side member of the slide tube 7 is, as shown in FIG. 8, a first cylindrical member 72 and a second cylinder having substantially the same outer diameter and inner diameter as the first cylindrical member 72. And an outer tube portion constituted by the cylindrical member 73, and a third cylindrical member 74 disposed in the 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 is suitable. And the pulling wires 6a and 6b are being fixed to the inner surface of the ring-shaped member 75 with the fixing | fixed part 75a, as shown in FIG. 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.

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 FIGS. 4 and 8, the distal end portion of the slide tube 7 is not joined and is not substantially in contact with the small-diameter portion of the tubular member 5 for accommodating a stent. The base end portion of 51a is encapsulated. 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 0.03 to 0.1 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 to 4, 7, and 9, the fixed tube 8 includes a distal end side fixed tube 81 having a large outer diameter and a distal end side fixed tube 81 of the distal end side fixed tube 81. A proximal end side fixing tube 82 fixed to the proximal end portion 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 stationary tube 8, specifically, at a position that becomes the proximal end portion of the distal end side stationary tube 81 as shown in FIG. 9. 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.

Further, in this embodiment, as shown in FIG. 9, the distal end 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. 9, 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.
At the proximal end portion of the distal tube 2, a cylindrical fixing member 83 that houses the proximal end portion is provided, and at the distal end of the proximal tube 4, a tubular fixing member 84 is provided. . As shown in FIGS. 7 and 9, a cylindrical fixing member 83 and a 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) For example, polyethylene, polypropylene, nylon, polyethylene terephthalate in consideration of physical properties (flexibility, hardness, strength, slipperiness, kink resistance, stretchability) required for the cylindrical member for housing the stent. Fluorine polymers such as polyimide, PTFE and ETFE, 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 the stent 3 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. A pulling wire 6 extending in the proximal tube 4 is provided. 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 FIGS. 1, 2, 5 to 8, and 10, the living organ dilator 1 includes a plurality (specifically, two) of pulling wires 6 a and 6 b, The pulling wires 6a and 6b are fixed to the proximal end portion of the stent-accommodating tubular member 5 by fixing points 69a and 69b that are provided at portions that are considerably close to the stent. The pulling wires 6a and 6b and the fixing points 69a and 69b are arranged so as to be separated from each other by a predetermined distance.

  Further, in this embodiment, the pulling wires 6a and 6b are fixed to members that move by pulling. Specifically, as shown in FIG. 8 and as described above, the pulling wires 6a and 6b are also fixed to a ring-shaped member 75 (specifically, the inner surface) of the slide tube 7. 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, 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 that is a member that moves by pulling. The release between the pulling wires 6a, 6b and the stent housing tubular member 5 is reliably 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 4 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 4, 7, and 9, the rigidity imparting body 11 extends from the proximal end side of the living organ dilator 1, passes through the proximal end side tube 4, and further enters the fixed tube 8. is doing. 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. 3, the pulling wires 6 a and 6 b are not fixed to the slide tube locking portion 24 and pass through passages 24 a and 24 b formed in the slide tube locking portion 24.

Furthermore, in the living organ dilator 1 of this embodiment, as shown in FIG. 9, 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. 9, the cylindrical fixing member 84 is formed with a rigidity imparting body fixing portion 84 a 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 4 at the base end part, or the operation part 10 mentioned later. 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 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).

The stent 3 is housed in the stent housing tubular member 5.
The stent 3 may be any so-called self-expanding stent. For example, as the stent 3, one having a shape as shown in FIG. 16 (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 150 mm. More preferably, it is 15-100 mm.

  The shape of the stent is not limited to that shown in FIG. For example, a trapezoidal cutout is formed at both ends and a plurality of hexagonal openings are formed in a honeycomb shape at the center, and a rectangular cutout is formed at both ends. The part may have a plurality of rectangular openings (having twice the length of the notch). Furthermore, the shape of the stent 3 is not limited to the above-described shape as long as it can be reduced in diameter when inserted 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.

Note that the living organ dilator according to the present invention is not limited to the above-described embodiments. For example, the living body expansion device 20 shown in FIG. 11 may be used.
In the living organ dilator 20 of this embodiment, the fixing tube 8 does not include the distal end side fixing tube 81 and the proximal end side fixing tube 82 as in the above-described living organ dilator 1 but is integrally formed. The fixed tube 8a is provided. And as shown in FIG. 11, the fixed tube 8a is provided with the reinforcement layer 85 extended from the front end side to the arrangement | positioning vicinity of the slide tube latching | locking part 24. As shown in FIG. The reinforcing layer is the same as described above.

Furthermore, in all the embodiments described above, the living body expansion device 30 shown in FIG. 12 may be used.
In the living organ dilator 30 of this embodiment, the distal end portions (69a, 69b) of the pulling wires 6a, 6b are fixed by the metal ring 54 fixed to the small diameter portion 51a of the stent housing tubular member 5. Yes. And the coating | coated part 55 formed with resin etc. is provided in the outer surface of the metal ring 54, and the front-end | tip of the metal ring 54 and the pulling wires 6a and 6b shall not be exposed. The living organ dilator 30 of this embodiment does not have the cylindrical portion 52 that encloses the small-diameter portion 51a of the stent housing tubular member 5 provided in the living organ dilator 1.
In all the embodiments described above, unlike the slide tube locking portion 24c of the living organ dilator 30 shown in FIG. 12, there is no passage for penetrating the pulling wires 6a and 6b, and the pulling wires 6a and 6b are not provided. However, it may pass the outside of the slide tube locking portion 24c.

Furthermore, in all the above-described embodiments, it may be a living organ dilator 40 shown in FIG.
In the living organ dilator 40, the pull wires 6a and 6b are fixed to the inner surface of the slide tube 7a.
The slide tube 7a in this embodiment does not include the ring-shaped member 75 housed in the non-fixed state in the slide tube included in the living organ dilator 1. Specifically, as shown in FIG. 13, the slide tube 7 a 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 7a includes a first cylindrical member 72 and a second cylindrical member 73 having substantially the same outer diameter and inner diameter as the first cylindrical member 72. An outer tube portion configured, an inner tube portion configured by a third cylindrical member 74 disposed in a proximal end portion of the first cylindrical member 72 and a distal end portion of the second cylindrical member 73; An outer tube and an inner tube are fixed, in other words, a first cylindrical member 72, a second cylindrical member 73, and a fixing portion 76 that fixes the third cylindrical member 74 are provided. The pulling wires 6a and 6b are fixed by the fixing portion 76 and pass through the fixing portion. As a result, the pulling wires 6 a and 6 b are directly fixed to the slide tube 7. Also in this embodiment, since the pulling force of the pulling wires 6a and 6b is distributed to the fixing portions between the fixing points 69a and 69b and the slide tube 7a, the pulling wires 6a and 6b and the stent at the fixing points 69a and 69b are distributed. The fixing between the storage tubular members 5 is surely prevented.

Furthermore, in all the above-described embodiments, it may be a living organ dilator 60 shown in FIG.
In this living organ dilator 60, the pulling wires 6a and 6b are not fixed to the inner surface of the slide tube 7b. Moreover, the ring-shaped member 75 accommodated in a non-fixed state in the slide tube 7 provided in the living organ dilator 1 is not provided.
Specifically, as shown in FIG. 14, the slide tube 7 b includes a slide tube main body 71 and a distal end side member 72 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. The pulling wires 6a and 6b pass through the slide tube 7 without being fixed to the slide tube 7b.

Further, in all of the above-described embodiments, the living body expansion device 100 shown in FIG. 15 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.

The living organ dilator 1 of the present invention includes an operation unit 10 fixed to the proximal end of the proximal tube 4 as shown in FIGS. 1, 17 to 21.
FIG. 17 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to the present invention. FIG. 18 is an enlarged rear view of the vicinity of the operation unit of the biological organ dilator shown in FIG. FIG. 19 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG. FIG. 20 is a right side view of only the operation part of the living organ dilator shown in FIG. FIG. 21 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.

As shown in FIGS. 17 to 21, the operation unit 10 includes an operation unit housing 50. 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. 19, the front-end | tip part of the cylindrical connector 45 is being fixed to the base end of the base end side tube 4. 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. 19, 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 70 a 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. 17 to 20, 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. As shown in FIGS. 17 and 18, the bearing portions 94 a and 94 b are bowl-shaped members that house one end 64 b and the other end 64 a of the rotation shaft of the roller 61 and extend in a direction away from the above-described opening. It has become. The bearing portions 94a and 94b are not limited to a hook shape, and may be any one that can move by a distance that allows the engagement with the locking rib to be released. For example, the shape of the bearing portions 94a and 94b may be an ellipse, a rectangle, an ellipse, or the like. In particular, in the operation unit 10 of this embodiment, the bearings 94a and 94b are bowl-shaped as shown in FIGS. For this reason, the operation rotating roller 61 is pushed, and the end portions 64a and 64b of the rotating shaft of the roller 61 housed in the one end side space of the bearing portions 94a and 94b are formed on the inner side surfaces of the central portions of the bearing portions 94a and 94b. By overcoming the opposite rib portions, the end portions 64a and 64b of the rotating shaft of the roller 61 are housed in the other end side space of the bearing portions 94a and 94b. The state shown in FIG. 19 is a state where the roller 61 is pressed. In this state, the roller 61 is pressed by the urging member, but the end portions 64a and 64b of the rotating shaft of the roller 61 abut against the opposing rib portions formed on the inner side surfaces of the central portions of the bearing portions 94a and 94b. Since it contacts, it does not move to the one end side space of the bearing portions 94a and 94b. For this reason, the roller 61 maintains a rotatable state.

  In this embodiment, as shown in FIGS. 18 and 21, the operation unit 10 includes a collar member 12. The collar member 12 has a collar portion 14 that houses the winding shaft portion 63 and forms an annular space between the winding shaft portion 63. The collar portion 14 prevents the pulling wire wound around the winding shaft portion 63 from loosening. The collar member 12 also has a function of suppressing movement of the rotating roller when it is pressed and suppressing rattling of the rotating roller. The pin 13 of the collar member 12 is pivotally supported by the protruding portion (bearing portion) 59 of the first housing 50a and the concave portion (bearing portion) 158 of the second housing 50b. As shown in FIGS. 17 and 18, 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 a length that can move a distance greater than the height of the rib. As shown in FIG. 21, the collar member 12 includes two notch portions 15 that face each other and reach the space in the collar portion 14 from the side surface. The pulling wire 6 passes through one of the cutout portions 15 and is fixed to the winding shaft portion 63.

  The pulling wire winding mechanism 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. 18, the proximal end portion of the pulling wire 6 includes an anchor portion 65 formed larger than the wire 6, and the winding shaft portion 63 stores the pulling wire 6. A possible slit 63a is provided. 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. Further, as shown in FIGS. 17, 19, and 20, 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. 17 to 19, the operation rotating roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Further, as shown in FIGS. 18 and 20, 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. Therefore, when the rotating roller 61 is urged by the urging member 80, the rotating roller 61 is in a state shown in FIG. 18, and the locking rib engages with the protruding portion of the gear portion 62, so that the rotating roller 61 is not rotatable. 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. 17 to 19, 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. 19 (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. Further, in the operation unit 10, as shown in FIG. 20, the reverse rotation restricting member (biasing member) 80 is disposed between the inner surface of the first housing 50 a and the side surface of the rotating roller 61. For this reason, the movement of the reverse rotation restricting member (biasing member) 80 in the lateral direction (horizontal direction) is restricted by the inner surface of the first housing 50 a and the side surface of the rotating roller 61.

The gear 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 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 stent 3 is brought into contact with and locked with the distal end surface of the stent proximal end locking portion 22 of the distal tube 2, the stent 3 is accommodated as the stent accommodating tubular member 5 moves. It is discharged from the tip opening of the cylindrical member 5. By this release, as shown in FIG. 10, the stent 3 is self-expanding to expand the stenosis part and is placed in the stenosis part.

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. 4 is a cross-sectional view taken along line AA in FIG. 5 is an enlarged cross-sectional view taken along line BB in FIG. 6 is an enlarged cross-sectional view taken along the line CC of FIG. 7 is an enlarged cross-sectional view taken along the line DD of FIG. FIG. 8 is an enlarged cross-sectional view of the proximal end portion of the tubular member for housing a stent and the vicinity of the distal end portion of the slide tube of the living organ dilator shown in FIG. FIG. 9 is an enlarged cross-sectional view of the vicinity of the proximal end portion of the fixed tube of the living organ dilator shown in FIG. FIG. 10 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention. FIG. 11 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. 12 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. 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 external view of an example of a stent used in the living organ dilator according to the present invention. FIG. 17 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to the present invention. FIG. 18 is an enlarged rear view of the vicinity of the operation unit of the biological organ dilator shown in FIG. FIG. 19 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG. FIG. 20 is a right side view of only the operation part of the living organ dilator shown in FIG. FIG. 21 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Biological organ dilator 2 Front end side tube 3 Stent 4 Proximal end side tube 5 Tubular member 6 for stent accommodation (6a, 6b) Pulling wire 7 Slide tube 8 Fixed tube 10 Operation part 11 Stiffness imparting body

Claims (14)

A distal tube having a guide wire lumen, a proximal tube, a stationary tube having an opening communicating with the guide wire lumen while the proximal portion of the distal tube and the distal portion of the proximal tube are fixed A tubular member for stent storage that encloses the distal end side of the distal tube and is slidable in the proximal direction of the distal tube; and a stent that is housed in the tubular member for stent storage; The stent-housing tubular member is fixed to the stent-housing tubular member, extends in the proximal tube and is pulled toward the proximal end of the proximal tube, thereby bringing the stent-housing tubular member to the proximal side A living organ dilator comprising at least one puller wire for movement to
The distal end tube is positioned on the distal end side of the distal end side tube, contacts the proximal end of the stent housed in the stent housing tubular member, and restricts movement of the stent toward the proximal end side. A stent proximal end locking portion, wherein the stent is formed in a substantially cylindrical shape, and is stored in the stent storage tubular member in a compressed state in the central axis direction. At the time of discharge from the cylindrical member for use, it expands outward to restore the shape before compression,
The living organ dilator includes a slide tube arranged so as to be close to a proximal end of the stent housing tubular member, and the fixed tube can store the slide tube from the proximal end side or the slide The tube can be fitted from the base end side, and the slide tube can be moved to the base end side together with the stent storage tubular member by pulling the pull wire, and the stent storage tubular member A living organ dilator which is not fixed. 2. The stent storage tubular member includes a small diameter portion provided at a proximal end portion, and the slide tube encloses the proximal end portion of the small diameter portion of the stent storage tubular member. The living organ dilator described in 1. The living organ according to claim 1 or 2, wherein the cylindrical member for housing a stent includes a small diameter portion provided at a proximal end portion, and a distal end portion of the pulling wire is fixed on an outer surface of the small diameter portion. Expansion device. The living organ dilating instrument according to claim 2 or 3, wherein the cylindrical member for housing a stent includes a cylindrical part that encloses the small diameter part. The cylindrical member for stent accommodation includes a small diameter portion provided at a proximal end portion, and a distal end portion of the pulling wire is fixed by a metal ring body attached to an outer surface of the small diameter portion. 4. The living organ dilator according to any one of 4 above. The living organ dilator according to any one of claims 1 to 5, wherein the pulling wire is fixed to an inner surface of the slide tube or a member that moves by pulling the pulling wire. The fixed tube is capable of storing the slide tube from the proximal end side, and the distal tube is located in the fixed tube so that the proximal end of the slide tube can come into contact therewith. The living organ dilator according to any one of claims 1 to 6. The living organ expanding device includes a linear rigidity imparting body that passes through the proximal end side tube and enters the fixed tube, and a distal end portion of the linear rigidity imparting body is fixed to the slide tube locking section. The living organ dilator according to claim 7. The living organ dilator according to claim 7 or 8, wherein the fixing tube includes a rigidity imparting body fixing portion provided on a proximal end side with respect to the slide tube locking portion. The operation part provided with the pulling wire winding mechanism for winding up the pulling wire and moving the cylindrical member for stent accommodation to the base end side at the base end part of the base end side tube. 9. The living organ dilator according to any one of 9 above. The operation portion includes an operation portion housing, and the pulling wire winding mechanism includes an operation rotating roller having a portion exposed from the operation portion housing, and the rotation roller is rotated to rotate the pulling wire to a base end. The living organ dilator according to claim 10, which is wound on the side. The living organ dilator according to claim 10 or 11, wherein the operation unit includes a lock mechanism that releasably locks the rotation of the pulling wire winding mechanism. The living organ expansion according to any one of claims 10 to 12, 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. Instruments. 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 10 to 13, wherein a proximal end portion of the pulling wire is fixed to the body.

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