JP4805082B2 - Biological organ dilator - Google Patents

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.
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. However, since the stent itself has no expansion force, the diameter is reduced with time due to the pressure of the blood vessel and the like, and there is a high possibility that restenosis will occur.

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.

  For example, Japanese Patent Application Laid-Open No. 11-503054 proposes a system composed of three tubular members. This has an outermost tube in addition to the inner tube and the outer tube. The stent is housed and restrained between the inner tube and the outer tube, and the outermost tube and the inner tube are fixed outside the body so that they do not move. With this configuration, the outermost tube is related to friction with the body cavity and the valve. However, in order to expand, only the outer tube is pulled, so that the position movement of the stent is extremely small.

  Moreover, in the thing of patent document 2 (Japanese translations of PCT publication No. 2003-521307), the housing provided with the slider which can be translated is proposed. This is where the tip inner shaft is attached inside the housing and the proximal end of the tip outer tube is connected to a slider that can move longitudinally within the housing, and sliding the slider proximally releases the stent It is a system to let you.

Japanese National Patent Publication No. 11-503054 JP-T-2003-521307

The self-expanding stent delivery system is of the over-the-wire type in which a guide wire lumen extending from the proximal end to the distal end extends as in Patent Documents 1 and 2 described above. This is due to the need to move the outer sheath proximally due to the structure for releasing the stent.
When performing in-stent placement of a stent, a plurality of stent delivery systems having different outer diameters, outer diameters at the time of stent expansion (after release), and the like are prepared. Then, after the first stent delivery system is inserted into the blood vessel, it may be replaced with another system. In the over-the-wire type, the guide wire lumen penetrates from the forefront to the end, and a guide wire more than twice the total length of the system is required to introduce the system into the body. For this reason, it takes time to replace the system.

  The structure of the delivery system for the self-expanding stent is as described above, in which the stent is housed and restrained between the inner tube and the outer tube and the movement of the stent is restricted on the stent proximal end side of the inner tube. And by pulling the outer tube toward the proximal end, the stent is released and self-expanded.

Japanese Patent Application Laid-Open No. 2003-521307 discloses a housing having a slider that can move in parallel. This is where the tip inner shaft is attached inside the housing and the proximal end of the tip outer tube is connected to a slider that can move longitudinally within the housing, and sliding the slider proximally releases the stent It is a system to let you.
In Patent Documents 1 and 2, it is necessary to move the entire curved inner shaft inserted into the living body in the proximal direction, and this operability is not good.
Accordingly, an object of the present invention is a living organ expansion device using a self-expanding stent, in which a movement of an outer tube for releasing a stent is easy, and a living organ capable of performing a stent placement operation easily and reliably. An expansion device is provided.

What achieves the above object is as follows.
(1) A distal end tube having a guide wire lumen, a proximal end tube having a distal end portion fixed to the proximal end portion of the distal end side tube, enveloping the distal end side of the distal end side tube, and A stent housing tubular member slidable in the proximal direction, a stent housed in the stent housing tubular member, and one end portion fixed to the stent housing tubular member, the proximal side A living organ dilator comprising a pulling wire for moving the stent-accommodating tubular member to the proximal end side by extending inside the tube and pulling to the proximal end side of the proximal end tube;
The distal tube is open on the proximal side of the distal tube and communicates with the guide wire lumen, and is positioned on the distal side of the distal tube, and is disposed in the tubular member for storing the stent. A stent locking portion that abuts the proximal end of the stent housed in the housing and restricts the movement of the stent toward the proximal end. The stent is formed in a substantially cylindrical shape and has a central axial direction. Is stored in the stent-accommodating tubular member in a compressed state, expanded outwardly when discharged from the stent-accommodating tubular member, and restored to the shape before compression, and The stent housing tubular member includes a projecting portion projecting inwardly and proximally from the inner surface of the axial intermediate portion of the stent housing tubular member, and the projecting portion and the stent housing tubular member. Void formed between inner surfaces With the door, the tip portion of the pulling wire penetrates into the gap portion, the stent delivery system that is fixed to the stent-containing tubular member in the airspace.

(2) The projecting portion is an annular projecting portion projecting inwardly and proximally from the inner surface of the axial intermediate portion of the stent housing tubular member, and the gap portion includes the annular projecting portion and the annular projecting portion. The living organ expansion device according to (1), wherein the proximal end side formed between the inner surfaces of the stent-accommodating tubular member is an annular void portion opened.
(3) The biological organ dilator includes a connection tube fixed to a distal end portion of the proximal end side tube at a proximal end portion, and the connection tube opens the proximal end portion of the distal end side tube to the proximal end side. The living organ dilator as set forth in (1) or (2), wherein is fixed so as to be exposed at the side surface of the connection tube.
(4) The connection tube includes an intermediate tube portion that extends in a distal direction and is capable of entering the stent-housing tubular member when the stent-housing tubular member moves toward the proximal end; and The intermediate organ expansion device according to any one of (1) to (3), wherein the intermediate tube portion is longer than the entire length of the stent.

(5) The distal tube includes a guide tube portion having one end on the proximal end side from the stent locking portion and extending in the proximal direction, and partially encapsulating or expanding the diameter of the distal tube. The living organ dilator according to any one of (1) to (4) above.
(6) One end portion of the guide tube portion is located slightly on the distal end side from the protruding portion of the stent housing tubular member, and the guide tube portion is longer than the entire length of the stent. The living organ dilator described in (5) above.
(7) The biological organ dilator according to any one of (1) to (6), wherein two pulling wires are provided.

(8) The living organ dilator includes a rigidity imparting body that passes through the proximal end side tube and enters the stent-accommodating tubular member, and a distal end portion of the rigidity imparting body is attached to the distal end side tube. The living organ dilator according to any one of (1) to (7), which is fixed.
(9) The distal end portion of the rigidity imparting body is positioned within the proximal end portion of the stent-accommodating tubular member, and the distal end side at a position that is proximal to the guide tube portion of the distal end side tube. The living organ dilator according to (8), which is fixed to a tube.

(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 diameter smaller than that of the operation rotating roller portion, The living organ dilator according to any one of (10) to (13), wherein a base end portion of the pulling wire is fixed to a winding shaft portion.

  The living organ dilator according to the present invention includes a pulling wire for pulling a stent storing tubular member storing a stent therein in the proximal direction. The stent-accommodating tubular member includes a projecting portion projecting inwardly and proximally from the inner surface of the axial intermediate portion of the stent-accommodating tubular member, and the projecting portion and the inner surface of the stent-accommodating tubular member The tip portion of the pulling wire penetrates into the gap and is fixed to the stent housing tubular member in the gap. For this reason, there is little deformation of the stent-housing tubular member during pulling with the pulling wire, the movement of the stent-housing tubular member in the proximal direction is good, and the movement of the outer tube for releasing the stent becomes easy. Thus, the stent placement operation can be easily and reliably performed.

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 a cross-sectional view taken along line AA in FIG. 4 is an enlarged cross-sectional view taken along line BB in FIG. FIG. 5 is an enlarged cross-sectional view taken along the line CC of FIG.
The living organ dilator 1 of the present invention includes a distal tube 2 having a guide wire lumen 21, a proximal tube 4 having a distal end fixed to the proximal end of the distal tube 2, and the distal end of the distal tube 2. A stent housing tubular member 5 enclosing the side and slidable in the proximal direction of the distal tube 2, a stent 3 housed in the stent housing tubular member 5, and a stent housing tubular member One end is fixed to the member 5 and extends in the proximal tube 4 and is pulled to the proximal side of the proximal tube, thereby moving the stent housing tubular member 5 to the proximal side. And a pulling wire 6 constituting the.

The distal tube 2 is open on the proximal side of the distal tube 2 and communicates with the guide wire lumen 21. The distal tube 2 is positioned on the distal side of the distal tube 2 and has a cylindrical shape for storing a stent. A stent locking portion 22 that contacts the proximal end of the stent 3 housed in the member 5 and regulates the movement of the stent 3 toward the proximal end side is provided. The stent 3 is formed in a substantially cylindrical shape, is stored in the stent-accommodating tubular member 5 in a compressed state in the central axis direction, and is expanded outward when discharged from the stent-accommodating tubular member 5. It restores the shape before compression.
The stent-accommodating tubular member 5 includes a projecting portion 51a projecting inward from the inner surface of the axial intermediate portion of the stent-accommodating tubular member 5 in the proximal direction, the projecting portion 51a, and the stent housing tube. And a gap 53 formed between the inner surfaces of the shaped member 5. The distal end portion 69 (69a, 69b) of the pulling wire 6 (6a, 6b) penetrates into the gap portion 53 and is fixed to the stent housing tubular member 5 in the gap portion 53.

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 when the guide wire extending from the proximal end side opening to the proximal end side is along the side surface of the proximal end tube, it is equal to the outer diameter of the maximum diameter portion at the distal end side from the proximal end tube of the biological organ dilator. And 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 according to this embodiment includes a distal end side tube 2, a proximal end side tube 4, a stent housing tubular member 5, a stent 3, a pulling wire 6, and an operation unit 10 having a pulling mechanism for the pulling wire 6. ing.
The living organ dilating instrument 1 of this embodiment includes a connection tube 7 fixed to the distal end portion of the proximal end side tube 4 at the proximal end portion, and the connection tube 7 includes the proximal end portion of the distal end side tube 2. The proximal end opening 23 is fixed so as to be exposed at the side surface of the connection tube 7.

As shown in FIGS. 1 to 5, the distal tube 2 is a tube body having a guide wire lumen 21 that penetrates from the distal end to the proximal end, and has a distal end portion formed by a distal end member 25 fixed to the distal end. In addition, a tip opening 24 is provided. Note that the distal end portion may be formed integrally with the distal end side tube. The distal tube 2 is fixed to the distal end of the proximal tube 4 at the proximal end. Further, a proximal end opening 23 is provided at the proximal end portion (the proximal end in this embodiment) of the distal end side tube 2. Further, the proximal end portion of the distal tube 2 is curved as shown in FIG. And the base end side opening 23 is diagonally formed so that it may incline toward the base end side, as shown in FIG. 1 thru | or FIG. 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 FIG. 3, the distal tube 2 includes a stent locking portion 22 that restricts the movement of the in-body cavity placement stent 3 toward the proximal end. The locking part 22 is preferably an annular protrusion. The distal end side of the stent locking portion 22 is a stent housing portion. 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.

  The outer diameter of the stent locking portion 22 is preferably 0.8 to 4.0 mm. The stent locking portion 22 is preferably an annular protrusion as shown in the figure, but may be any one that restricts the movement of the stent 3 and can be extruded. For example, the stent locking portion 22 may be integrated with the distal tube 2 or as a separate member. One or a plurality of protrusions may be provided. Further, the stent locking portion 22 may be formed of a separate member from an X-ray contrast material. Thereby, the position of the stent can be accurately grasped under X-ray contrast, 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.

As shown in FIGS. 1 to 10, the proximal-side 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 proximal end portion of the distal end side tube 2. The proximal side tube 4 includes a pulling wire lumen 41 into 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 living organ dilator 1 of this embodiment includes a connection tube 7 fixed to the distal end portion of the proximal end side tube 4 at the proximal end portion, and the distal end side tube 2 is connected to the distal end side tube 2 in the proximal end portion. The end opening 23 is fixed so as to be exposed at the side surface of the connection tube 7.
The connection tube 7 includes an intermediate tube portion 47 that extends in the distal direction and can enter the stent housing tubular member 5 when the stent housing tubular member 5 moves toward the proximal end. The length of the intermediate tube portion 47 is longer than the entire length of the stent 3. In the living organ dilator 1 of this embodiment, the intermediate tube portion 47 constituting the intermediate tube portion having a smaller diameter than the connection tube is fixed to the distal end portion of the connection tube 7. The intermediate tube portion 47 may be formed integrally with the connection tube. In addition, the outer diameter of the intermediate tube part 47 has an outer diameter that can enter into the stent housing tubular member 5 described later. Further, as shown in FIG. 3, the intermediate tube portion 47 is a cylindrical portion extending with substantially the same outer diameter and inner diameter.

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 discharge port of the stent 3 when the stent 3 is placed in a stenosis in the body cavity. As shown in FIG. 7, the stent 3 is expanded from the distal end opening to release the stress load, and expands to restore 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 tubular member 5 for storing a stent includes a protruding portion 51a that protrudes inward and in the proximal direction from the inner surface of an intermediate portion in the axial direction of the cylindrical member 5 for stent storing, and the protruding portion 51a and the stent storing tubular member 5 And a gap 53 formed between the inner surfaces of the cylindrical member 5. The distal end portion 69 (69a, 69b) of the pulling wire 6 (6a, 6b) penetrates into the gap portion 53 and is fixed to the stent housing tubular member 5 in the gap portion 53. The projecting portion 51a is an annular projecting portion projecting inwardly and proximally from the inner surface of the axially intermediate portion of the stent-accommodating tubular member 5, and the void portion includes the annular projecting portion and the stent housing. It is preferable that it is the cyclic | annular space | gap part which the base end side formed between the inner surfaces of the cylinder member for use opened.

  In the living organ dilator 1 of this embodiment, the stent-accommodating tubular member 5 includes a distal-end-side tubular portion 51 and a proximal-end tube whose distal end is fixed to the proximal end portion of the distal-end-side tubular portion 51. A shaped portion 52 is provided. The proximal end portion of the distal end side cylindrical portion 51 is provided with a reduced diameter portion 51a that forms the above-described protruding portion. The reduced 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 base end side cylindrical part 52 is being fixed to the base end part of the front end side cylindrical part 51 so that the diameter reducing part 51a of the front end side cylindrical part 51 may be enclosed. For this reason, the reduced diameter portion 51 a of the distal end side cylindrical portion 51 constitutes an annular protruding portion 51 a that protrudes inward and in the proximal direction of the cylindrical member 5. An annular gap 53 is formed between the annular protrusion 51a and the inner surface of the stent-accommodating tubular member 5 (specifically, the distal end of the proximal-side tubular portion). The gap is filled with an adhesive, and the distal end side cylindrical portion 51 and the proximal end side cylindrical portion 52 are integrated. For the adhesion, 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 addition, tip portions (fixed points) 69 (69a, 69b) of the pulling wires 6 (6a, 6b), which will be described later, are fixed to the cylindrical member 5 by an adhesive filled in the annular gap. In addition, the base end portion 52a of the base end side cylindrical portion 52 is also a tapered portion that decreases in diameter toward the base end side. In particular, as shown in FIGS. 3 and 5, the base end portion 52 a does not reduce in diameter toward the center but becomes an eccentric diameter-reduced portion that decreases in diameter toward a point shifted from the center toward the outer periphery. Yes. The diameter may be reduced in the central direction. Further, the inner diameter of the base end portion 52a of the base end side cylindrical portion 52 is substantially equal to or slightly larger than the outer diameter of the intermediate tube portion 47 of the connection tube 7 described above.

  And in the cylindrical member 5 for stent accommodation used in this Example, the front end side cylindrical part 51 and the proximal end side cylindrical part 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 distal end side cylindrical portion 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.

  The stent-accommodating tubular member 5 is not limited to the distal end side tubular portion 51 and the proximal end side tubular portion 52 as described above, and may be an integral member. Further, like the living organ dilator of the embodiment shown in FIG. 6, the proximal-side cylindrical portion 52 includes a first proximal-side tubular portion 52b and a second base connected to the proximal end. It may consist of the end side cylindrical part 52c. In this case, it is desirable that the distal end portion of the second proximal-side cylindrical portion 52c be a reduced diameter portion that can enter the proximal end portion of the first proximal-side tubular portion 52b.

In the living organ dilator 1, the stent housing tubular member 5 slides outside the intermediate tube portion 47. As described above, the stent-accommodating tubular member 5 has the same outer diameter over substantially the entire length, and the intermediate tube portion 47 also has the same outer diameter over the entire length except for the proximal end portion. The outer diameter of the intermediate tube portion 47 is approximately equal to or slightly smaller than the inner diameter of the stent housing tubular member 5. Therefore, in the living organ dilator 1 of this embodiment, the stent housing tubular member 5 has the largest diameter portion in this system.
As described above, the connection tube 7 includes the intermediate tube portion 47. The distal end portion of the intermediate tube portion 47 has entered the inside of the proximal end of the stent housing tubular member 5. 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. In the space 53 provided in the tubular member 5, the tubular member 5 is fixed to the inside of the stent housing tubular member 5 by fixing points 69 a and 69 b. The pulling wires 6a and 6b and the fixing points 69a and 69b are separated by a predetermined length.

  In the living organ dilator 1 of this embodiment, the distal tube 2 has one end on the proximal end side from the stent locking portion 22 and extends in the proximal direction, and the distal tube 2 is partially covered. A guide tube portion 49 for enveloping or expanding the diameter is provided. And it is preferable that the one end part of the guide tube part 49 is located in a little tip side rather than the protrusion part 51a of the cylindrical member 5 for stent accommodation. The guide tube portion 49 is preferably longer than the entire length of the stent 3.

  Specifically, in the living organ dilator 1 of this embodiment, the guide tube portion 49 is configured by a tube 49 provided so as to partially encapsulate the distal end side tube 2. The tube 49 is not fixed to the distal end side tube 2. Note that the guide tube portion may be fixed to the distal end side tube, or may be formed integrally with the distal end side tube. And the outer surface of this guide tube part 49 and the inner surface of the protrusion part 51a of the cylindrical member 5 for stent accommodation mentioned above are adjoining so that it may be spaced apart a little. By providing the guide tube portion 49, deformation of the stent-accommodating tubular member 5 and the distal side tube during movement of the stent-accommodating tubular member 5 in the proximal direction by pulling of the pulling wire is prevented, and the stent is accommodated. The movement of the tubular member 5 for use is made favorable.

  Further, as described above, the intermediate tube portion 47 and the stent-accommodating tubular member 5 are not bonded and are slidable, and the stent-accommodating tubular member 5 is pulled by pulling the pulling wires 6a and 6b. Moves to the proximal side. However, since the stent 3 is locked by the locking portion 22, the stent 3 is discharged from the stent housing tubular member 5. By adopting such a configuration, even if the entire tube is made of a soft material, the pulling wire is inside the tube, so it is possible to safely expand the stent without bending even in bent blood vessels. Become.

  As a forming material of the stent-accommodating tubular member 5 (the distal-side tubular portion 51, the proximal-side tubular portion 52), physical properties required for the stent-accommodating tubular member (flexibility, hardness, strength, slipperiness, Considering kink resistance and stretchability), for example, fluorine-based polymers such as polyethylene, polypropylene, nylon, polyethylene terephthalate, polyimide, PTFE, ETFE, and thermoplastic elastomer are preferable. 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 hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone. Examples of the method include coating or fixing. 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).

As shown in FIG. 3, priming openings 26 a and 26 b are provided at the proximal end portion of the distal tube 2. By using the openings 26a and 26b, it is possible to perform priming that replaces the air in the connection tube 47 and the proximal end portion of the stent housing tubular member 5 with the priming liquid. .
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. 13 (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.
Note that the shape of the stent is not limited to that shown in FIG. 13, 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, Alternatively, a rectangular cutout may be formed at both ends, and a plurality of rectangular openings (having twice the length of the cutout) may be formed at the center. 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.

  The living organ dilator 1 has one end fixed to the annular projecting portion of the stent-housing tubular member 5, the proximal end of the stent-housing tubular member 5, and the connecting tube 7 including the intermediate tube portion 47. A puller wire 6 that penetrates and extends through the proximal tube 4 is provided. Then, by pulling the pulling wire 6 to the proximal end side of the proximal end side tube, the stent housing tubular member 5 moves to the proximal end side.

  As shown in FIGS. 1 to 7, the living organ dilator 1 includes a plurality (specifically, two) of pulling wires 6a and 6b, and the pulling wires 6a and 6b are considerably stented. Are fixed to the above-described annular projecting portion 51a of the stent-housing tubular member 5 by an adhesive by fixing points 69a and 69b provided in a portion close to. 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, the fixing points 69a and 69b of the pulling wires 6a and 6b are formed to be flat portions in order to ensure the fixing with an adhesive or the like. Furthermore, a wave-like portion may be formed on the side surface to provide a stopper from fixing means such as an adhesive. It is also possible to make the wire tip into a ring shape, or to make a hole in the flat part.

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 10, 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 4, and further enters the stent housing tubular member 5. Yes. And the front-end | tip 11b of the rigidity provision body 11 is being fixed to the outer surface of the front end side tube 2 by the fixing | fixed part 11a as shown in FIG. 2 thru | or FIG. This fixing portion is preferably caulked or bonded with a tubular member (ring).
Further, the fixing position 11 a of the rigidity imparting body 11 to the distal tube 2 is slightly distal from the intermediate tube portion 47. Further, the fixing position 11 a of the rigidity imparting body 11 to the distal end side tube 2 is slightly closer to the proximal end than the proximal end of the guide tube 49. 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). Moreover, you may form the front-end | tip part 11b of the rigidity provision body 11 so that it may become a flat part, in order to ensure fixation by the fixing member 11a. 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 of both is a tapered portion 11c whose 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 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 and 8 to 11.
FIG. 8 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to the present invention. FIG. 9 is an enlarged rear view of the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 10 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG. FIG. 11 is a right side view of only the operating portion of the living organ dilator shown in FIG. FIG. 12 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 illustrated in FIGS. 8 to 12, 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.

  As shown in FIG. 10, the distal end portion of the cylindrical connector 55 is fixed to the proximal end of the proximal end side tube 4. Further, a sealing mechanism connected to the proximal end portion of the connector 55 is accommodated in the operation portion housing 50. As shown in FIG. 10, this sealing mechanism includes a sealing mechanism cylindrical main body member 70 having a distal end portion fixed to the rear end portion of the connector 55, and a cap member 71 fixed to the proximal end of the cylindrical main body member 70. A seal member 72 disposed between the cylindrical main body member 70 and the cap member 71, and a rigidity imparting body fixing member 73 housed in the cylindrical main body member. The main body member 70 and the cap member 71 include an opening that penetrates. The seal member 72 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 73. The rigidity imparting body fixing member 73 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 72. The elastic material is the same as described above.

  As shown in FIGS. 8 to 11, 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. 8 and 9, the bearings 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 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. 10 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. 9 and 12, 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) 75 of the first housing 50a and the concave portion (bearing portion) 158 of the second housing 50b. As shown in FIGS. 8 and 9, the bearing portions 94a and 94b are formed in a gentle arc shape centering on the pin 13 (bearing portions 75 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. 12, 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. 9, 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. 8, 10, and 11, 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 the rotation operation roller portion, 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.

In this embodiment, the winding shaft portion 63 is integrated with the rotating roller 61 so as to be coaxial. Furthermore, as shown in FIG. 8, the winding shaft portion 63 is provided on one side of the rotating roller 61. Then, by rotating the rotating roller 61, the winding shaft portion 63 also rotates at the same time. And it is preferable that there is little winding amount compared with the amount of rotation operations of a rotating roller. By doing so, it is possible to perform a slow winding.
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. 8 and 9, the operation rotating roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Further, as shown in FIG. 9, the gear portion 62 is provided on the other side surface side of the rotating roller 61 (in other words, the surface opposite to the surface on which the winding shaft portion 63 is provided). Therefore, the gear portion 62 and the winding shaft portion 63 are in a state of being partitioned by the wall formed by the operation roller portion.
Further, the operation rotating roller 61 is partially exposed from the opening, and this portion becomes an operation portion. The rotating roller is provided on the other end 64a of the rotating shaft provided on one side surface (specifically, the side surface of the gear portion) and on the other side surface (specifically, the side surface of the winding shaft). One end 64b of the rotating shaft is provided.

Further, the housing 50 is provided with a biasing means 80 that biases the rotating roller 61 toward the opening of the housing. Specifically, the roller 61 is urged by the urging means 80. Further, the housing 50 is provided with a locking rib (not shown) that can enter between the protrusions of the gear portion 62 of the rotating roller 61 urged by the urging member 80. For this reason, when the rotating roller 61 is urged by the urging member 80, the rotating roller 61 is in the state shown in FIG. 9, 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. 8 to 11, the operation rotating roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Furthermore, as shown in FIG. 11, 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. 8 to 10, 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 84 that can mesh with the gear portion, and an elastic member. A deformable portion 82 and a mounting portion 83 to the housing are provided. The first housing 50a includes a first protrusion (bearing part) 75 and a second protrusion 76 formed on the inner surface. The first protrusion 75 enters the elastically deformable portion 82 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 82. . Specifically, the inner surface shape of the elastically deformable portion 82 is an arc shape, and the first protrusion 75 is a cylindrical shape corresponding to the arc shape. The mounting portion 83 of the reverse rotation restricting member (biasing member) 80 has a shape that can be mounted between the first projecting portion 75 and the second projecting portion 76 formed in the first housing 50a. The reverse rotation restricting member (biasing member) 80 is made unrotatable when the storage portion 83 is mounted between the first protrusion 75 and the second protrusion 76 of the first housing 50a. At the same time, the operating rotary roller 61 is biased toward the opening 58 by the elastic force of the elastically deformable portion 82. Further, the mounting portion 83 of the reverse rotation restricting member (biasing member) 80 is restricted from moving in the lateral direction by a disk-like protrusion 13 a provided on the collar member 12.

As described above, pressing the roller 61 allows the roller to rotate. However, rotation in the direction of the arrow in FIG. 10 (direction in which the pulling wire is wound) is possible. However, when the roller 61 is rotated in the reverse direction, one tooth portion of the gear portion 62 and the reverse rotation restricting member ( (Engagement member) 80 is engaged with the meshing portion 84 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. 11, 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 most cases, the distal end of a guide wire already placed in the body is inserted into the opening 24 of the distal end member of the living organ dilator shown in FIGS. 1 and 2, and the guide wire ( (Not shown). 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 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-housing tubular member 5 moves to the proximal 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 locking portion 22 of the distal tube 2, the stent storing tubular member 5 is moved along with the movement of the stent storing tubular member 5. 5 is released from the tip opening. By this release, as shown in FIG. 7, the stent 3 is self-expanded to expand the stenosis and is placed in the stenosis.

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 a cross-sectional view taken along line AA in FIG. 4 is an enlarged cross-sectional view taken along line BB in FIG. FIG. 5 is an enlarged cross-sectional view taken along the line CC of FIG. FIG. 6 is an enlarged external view of a distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 7 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention. FIG. 8 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to the present invention. FIG. 9 is an enlarged rear view of the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 10 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG. FIG. 11 is a right side view of only the operating portion of the living organ dilator shown in FIG. FIG. 12 is an explanatory diagram for explaining the internal structure of the operation unit of the living organ dilator shown in FIG. FIG. 13 is an external view of an example of a stent used in the living organ dilator according to the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Living organ expansion instrument 2 The front end side tube 3 The stent 4 The proximal end side tube 5 The cylindrical member 6 for stent accommodation (6a, 6b) Pulling wire 10 Operation part 11 Stiffness imparting body

Claims (14)

A distal end tube having a guide wire lumen; a proximal end tube having a distal end fixed to a proximal end portion of the distal end tube; and a proximal direction of the distal end tube covering the distal end side of the distal end tube A cylindrical member for housing a stent, a stent housed in the tubular member for stent housing, and one end portion fixed to the tubular member for stent housing, A biological organ dilator having a pulling wire for extending the proximal end side of the proximal end side tube to move the stent housing tubular member to the proximal end side,
The distal tube is open on the proximal side of the distal tube and communicates with the guide wire lumen, and is positioned on the distal side of the distal tube, and is disposed in the tubular member for storing the stent. A stent locking portion that abuts the proximal end of the stent housed in the housing and restricts the movement of the stent toward the proximal end. The stent is formed in a substantially cylindrical shape and has a central axial direction. Is stored in the stent-accommodating tubular member in a compressed state, expanded outwardly when discharged from the stent-accommodating tubular member, and restored to the shape before compression, and The stent housing tubular member includes a projecting portion projecting inwardly and proximally from the inner surface of the axial intermediate portion of the stent housing tubular member, and the projecting portion and the stent housing tubular member. Void formed between inner surfaces With the door, the tip portion of the pulling wire penetrates into the gap portion, the stent delivery system, characterized in that it is fixed to the stent-containing tubular member in the airspace. The protruding portion is an annular protruding portion that protrudes inward and proximally from the inner surface of the axial intermediate portion of the stent-accommodating tubular member, and the gap portion includes the annular protruding portion and the stent accommodating portion. The living organ dilating instrument according to claim 1, wherein the proximal end side formed between the inner surfaces of the tubular member for use is an annular gap portion opened. The living organ dilator includes a connection tube fixed to a distal end portion of the proximal end side tube at a proximal end portion, and the connection tube connects the proximal end portion of the distal end side tube to the proximal end side opening. The living organ dilator according to claim 1 or 2, which is fixed so as to be exposed on a side surface of the tube. The connection tube includes an intermediate tube portion extending in a distal direction and capable of entering the stent storage tubular member when the stent storage tubular member moves toward the proximal end, and the intermediate tube portion The living organ dilator according to any one of claims 1 to 3, which is longer than the entire length of the stent. The distal end tube includes a guide tube portion having one end on the proximal end side from the stent locking portion and extending in the proximal direction and partially encapsulating or expanding the distal end tube. Item 5. A living organ dilator according to any one of Items 1 to 4. The one end portion of the guide tube portion is located slightly on the distal end side from the protruding portion of the stent housing tubular member, and the guide tube portion is longer than the entire length of the stent. The living organ dilator described in 1. The living organ dilator according to claim 1, wherein two pulling wires are provided. The living organ expansion device includes a rigidity imparting body that passes through the proximal end side tube and enters the cylindrical member for stent storage, and a distal end portion of the rigidity imparting body is fixed to the distal end side tube. The living organ dilator according to any one of claims 1 to 7. A distal end portion of the rigidity imparting body is fixed to the distal end side tube at a position that is located within the proximal end portion of the stent housing tubular member and that is proximal to the guide tube portion of the distal end side tube. The living organ dilator according to claim 8. 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 portion, and the winding shaft The living organ dilator according to any one of claims 10 to 13, wherein a base end portion of the pulling wire is fixed to a portion.

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