JP4928764B2 - 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 the structure of the balloon expandable stent delivery system is such that after the stent is placed in the target stenosis, only liquid is injected into the balloon, so that the stent moves back and forth when the stent is expanded. There is no. 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.
Further, the present applicant has proposed Patent Document 2 (Japanese Patent Laid-Open No. 8-252321). Even in this self-expanding stent delivery system, there is very little movement of the stent during stent expansion (during release).

Japanese National Patent Publication No. 11-503054 JP-A-8-252321 JP-T-2003-521307 JP-T-2004-527316 JP-T-2004-527316

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. At this time, the operator needs to pull the outer tube with the other hand while fixing the inner tube at a fixed position with one hand so that the indwelling position of the stent does not advance. Furthermore, when a biliary stent is placed in the bile duct via an endoscope, the inner tube cannot be fixed at a fixed position. Therefore, the stent should be expanded little by little while holding the endoscope. We are working to adjust the placement position of the stent by pulling the tube. In order to solve such operability problems, a system having a housing assembly has been invented.

Japanese Patent Application Laid-Open No. 2003-521307 discloses a housing including 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. Patent Document 3 states that it can be operated with one hand, but in reality, the housing must be used by being fixed to a fixed hard surface such as an operating table or the patient's foot. There is a possibility that the indwelling position of the medical device is shifted to an unintended position.
Patent Document 4 (Japanese Patent Laid-Open No. 2004-130074) proposes a housing assembly having a similar basic structure and having two or more operation modes having different speeds. Also in this system, the housing needs to be at least twice as long as the slider, so that the housing becomes relatively large and difficult to operate with one hand.
In patent document 5 (Japanese translations of PCT publication No. 2004-527316 gazette), the proximal end of the front-end | tip outer tube is connected to the track | truck in a housing, The system which releases a stent by gradually retracting | retreating this track | truck with a ratchet means is used. This makes it possible to operate with one hand. However, this system also requires a housing assembly that is more than twice the track, in other words, more than twice the length of the stent to be released.
In order to reduce the size of the housing and improve the operability, the inventors of the present invention use an operation portion of a type that winds a wire that pulls the restraint body of the stent to the proximal end side. It has been found that there is a possibility of unnecessary bending and damage of the catheter due to overwinding of the catheter.
An object of the present invention is a living organ expansion device using a self-expanding stent, and can be easily replaced with another living organ expansion device during stent placement, and the position of the stent can be moved during placement. Furthermore, the present invention provides a biological organ dilator that does not cause 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.

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 biological organ dilator comprising a pulling wire for extending the inside of the tube and moving the stent-accommodating tubular member to the proximal end side by pulling to the proximal end side of the proximal end side tube, The distal tube is open at the proximal end 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 stent-accommodating tubular member. Storage A stent locking portion that abuts the proximal end of the stent and restricts the movement of the stent toward the proximal end. The stent is formed in a substantially cylindrical shape and is compressed in the direction of the central axis. housed in has been the stent-containing tubular internal member in the state, during the indwelling is intended to restore the shape before compression by expanding outward, further the stent delivery device, said distal end An intermediate tube that encloses the proximal end side of the tube and the proximal end side of the tubular member for storing a stent, and is fixed to the proximal end portion of the distal end side tube and the distal end portion of the proximal end side tube at the proximal end portion The intermediate tube is encapsulated without restricting the movement of the stent-accommodating tubular member to the proximal end side, and further, the proximal end portion of the proximal end side tube is provided with the traction member. For winding the wire and storing the stent Stent delivery device having an operation section comprising a wire winding amount restriction mechanism for restricting a wire length to be pulled by pulling wire winding mechanism and the pulling wire winding mechanism for moving the Jo member proximally.

(2) 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 pulling wire is rotated by rotating the rotating roller. The living organ dilator according to (1), wherein the device is wound up at the proximal end side.
(3) The living organ expansion instrument according to (1) or (2), wherein the operation unit includes a lock mechanism that releasably locks the rotation of the pulling wire winding mechanism.
(4) In any one of (1) to (3), 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 biological organ dilator described.
(5) 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, The living organ dilator according to any one of (1) to (4), wherein a base end portion of the pulling wire is fixed to a winding shaft portion.
(6) The wire winding amount regulating mechanism is configured by a linear body having a predetermined length with one end gripped by the operation portion, and the other end of the linear body is the winding of the operation rotating roller. A linear body fixed to a take-up shaft portion or a linear body take-up shaft portion provided separately from the take-up shaft portion, and the linear body by rotating the operation rotating roller in the wire take-up direction. Is a device for expanding a living organ according to (5), in which no further winding is possible after winding the predetermined amount on the winding shaft portion or the linear body winding shaft portion.

(7) The wire winding amount regulating mechanism includes a linear body bobbin that grips one end of the linear body, is wound around the linear body, and is rotatably stored in the storage unit. The living organ dilator described in (6).
(8) The wire winding amount regulating mechanism is in contact with a protruding portion provided in the operation rotating roller and the operation rotating roller provided in the operation portion after being rotated in a wire winding direction by a predetermined amount, The living organ dilating instrument according to (5), further comprising a locking portion that restricts the rotation of the operation rotating roller.
(9) The protruding portion of the wire winding amount regulating mechanism can adjust the arrangement position of the operation rotating roller, and can adjust the rotatable amount of the operation rotating roller (8 The living organ dilator described in (1).
(10) The operation unit includes a connector connected to a proximal end portion of the proximal end side tube, and the connector includes a seal member through which the pulling wire penetrates in a liquid-tight manner (1) to ( The living organ dilator according to any one of 9).
(11) The living organ dilator includes a pulling wire position holding member that is positioned on an outer surface side of the distal tube and has a passage through which the pulling wire can pass. A biological organ dilator according to claim 1.

(12) The biological organ dilator has a protrusion located on the outer surface side of the distal tube, and the stent-housing tubular member extends from the proximal end to the distal end, and the protrusion advances. The living organ dilator according to any one of (1) to (11), which includes a slit capable of being used.
(13) The pulling wire winding mechanism encloses the winding shaft portion and the winding shaft portion, and forms an annular space between the outer surface of the winding shaft portion, and the winding shaft portion. The living organ dilator according to any one of (1) to (12), further comprising a collar portion that suppresses loosening of the puller wire wound around the wire.
(14) The tubular member for storing a stent has a stent storing portion which is a distal end side as an enlarged diameter portion, and a proximal end side is a small diameter portion with respect to the expanded diameter portion, and the stent storing When the tubular member for movement is moved to the proximal end side, the small-diameter portion of the stent-housing tubular member is accommodated in the intermediate tube, and the one end portion of the pulling wire is disposed in the intermediate tube is fixed to the stent-containing tubular member at an inner, further said pulling wire passes between said intermediate tube the distal-side tube, which is intended to extend to the proximal end side in the tube (1 ) To (13).
(15) The biological organ dilator according to any one of (1) to (14), wherein the distal end side tube includes a pulling wire passage through which the pulling wire can penetrate.
(16) The distal end side tube includes a small diameter portion for stent placement formed on the distal end side, and the stent locking portion is configured at a proximal end of the small diameter portion for stent placement (1). Thru | or the living organ expansion device in any one of (15).
(17) The living organ expansion device according to any one of (1) to (16), wherein two pulling wires are provided.

  Even if the living organ expanding device of the present invention is a living organ expanding device using a self-expanding stent, the proximal end side opening is not the proximal end of the device but the proximal end side of the distal end tube. 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, unnecessary bending and damage of the catheter due to excessive winding of the wire that pulls the stent restraint to the proximal end side is not generated.

A living organ dilator according to the present invention will be described with reference to an embodiment shown in the drawings.
FIG. 1 is a partially omitted front view of a living organ dilator according to an embodiment of the present invention, FIG. 2 is an enlarged external view of the vicinity of a distal end portion of the living organ dilator shown in FIG. FIG. 2 is an enlarged cross-sectional view of the vicinity of a distal end portion of the living organ dilator shown in FIG. FIG. 4 is an enlarged external view of the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 5 is an external view of an example of a stent-housing tubular member used in the living organ dilating instrument of the present invention. 6 is an enlarged sectional view taken along line AA in FIG. 2, and FIG. 7 is an enlarged sectional view taken along line BB in FIG. FIG. 8 is an enlarged left side view of the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 9 is an enlarged bottom view of the operation unit of the living organ dilator shown in FIG. 10 is a cross-sectional view taken along line CC in FIG. 8, and FIG. 11 is an enlarged cross-sectional view taken along line DD in FIG. 12 to 14 are explanatory views for explaining the operation of the living organ dilator according to the present invention. FIG. 28 is a perspective view of an example of a stent for indwelling in a body cavity used in the living organ dilating instrument of the present invention.

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 A pulling wire for moving the stent housing tubular member 5 to the proximal end side by fixing one end of the member 5 and extending the proximal end side tube 4 to the proximal end side of the proximal end tube. 6.
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 and is stored in the stent-accommodating tubular member 5 in a state compressed in the direction of the central axis, and is expanded outwardly and restored to the shape before compression when placed in the living body. Is.

A pulling wire 6 is wound around the proximal end portion of the proximal tube 4, and a pulling wire winding mechanism for moving the stent housing tubular member 5 to the proximal end side and the pulling wire winding mechanism are used. It has the operation part 9 provided with the wire winding amount control mechanism which controls the wire length wound up.
The operation unit 9 includes an operation unit housing 91 (91a, 91b), and the pulling wire winding mechanism includes an operation rotation roller 61 having a portion exposed from the operation unit housing 91, and rotates the rotation roller 61. Thus, it is preferable that the pulling wire 6 is wound on the proximal end side. In this way, the operation unit itself can be made compact, and the exposed rotation roller can be rotated while holding the operation unit housing. The discharge operation can be carried out substantially with one hand.
Moreover, as the biological organ dilator 1, 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 biological organ dilator 1. preferable. By doing in this way, even in the state where the guide wire extending from the base end side opening to the base end side is along the side surface of the base end side tube, It can be of the same extent as the outer diameter, and can be inserted into a small blood vessel.

The living organ dilator of this embodiment includes a distal end side tube 2, a proximal end side tube 4, a cylindrical member 5 for storing a stent, a stent 3, a pulling wire 6, a pulling wire 6 winding mechanism and a wire winding amount regulating mechanism. The operation unit 9 having the above is provided.
And in the living organ dilator 1 of this embodiment, the proximal end side of the distal end side tube 2 and the proximal end side of the stent housing tubular member 5 are encapsulated, and the proximal end portion of the distal end side tube 2 is surrounded by the proximal end portion. And an intermediate tube 7 fixed to the distal end portion of the proximal end side tube 4. In the living body organ dilator 1 of this embodiment, the intermediate tube 7 is encapsulated without restricting the movement of the stent housing tubular member 5 toward the proximal end, and one end of the pulling wire 6 Is fixed to the stent housing tubular member 5 in the intermediate tube 7, and the pulling wire 6 extends between the intermediate tube 7 and the distal tube 2 and into the proximal tube 4. Yes. This is preferable because there is no exposure of the pulling wire.

The stent-housing tubular member 5 is a tubular body having a predetermined length as shown in FIGS. 1, 2, 3, and 5. 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. When the stent 3 is pushed out from the opening of the distal end, the stress load is released and the stent 3 expands and is restored to 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 250 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. And the stent accommodation tubular member 5 used in this embodiment has a diameter-enlarged portion 51 at the distal end side of the stent accommodation site, and the proximal end side has a smaller diameter than the enlarged-diameter portion 51. Has become a department. And as an outer diameter of an enlarged diameter part, about 1.0-4.0 mm is preferable, and 1.5-3.0 mm is especially preferable. Moreover, as an outer diameter of a small diameter part, about 1.0-4.0 mm is preferable, and 1.2-2.8 mm is especially preferable. In addition, the cylindrical member for stent accommodation may have the substantially same outer diameter as a whole.

  The stent-accommodating tubular member 5 includes a slit 52 extending from the proximal end to the distal end side, as shown in FIGS. In the slit 52, a protrusion (in this embodiment, the tubular member 8 through which the pulling wire passes) formed on the outer surface of the distal end side tube, which will be described later, can travel. In this embodiment, the stent-housing tubular member 5 is movable to the proximal end side until the distal end side end portion of the slit comes into contact with the tubular member 8. Therefore, the slit 52 is equal to or slightly longer than the length from the proximal end of the stent 3 to the distal end of the stent housing tubular member 5 in the stent housing tubular member 5 housing the stent 3.

As a forming material of the stent-housing tubular member 5, in consideration of physical properties (flexibility, hardness, strength, slipperiness, kink resistance, stretchability) required for the stent-housing tubular member, for example, polyethylene, Fluorine polymers such as polypropylene, nylon, polyethylene terephthalate, PTFE, 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 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 stent 3 is housed at the distal end of the stent housing tubular member 5. The stent 3 is a so-called self-expanding stent. Specifically, the stent 3 is formed in a substantially cylindrical shape, is compressed in the central axis direction when inserted into a living body, and expands outward when placed in the living body to restore the shape before compression. And it is hold | maintained in the cylindrical member 5 for stent accommodation in the state compressed in the central axis direction. Therefore, the stent 3 is held in the stent-accommodating tubular member in a state where the inner surface of the stent-accommodating tubular member 5 is pressed by its own restoring force. Further, as will be described later, the movement of the stent 3 toward the proximal end side is restricted by the stent locking portion 22 provided in the distal end side tube 2.

The stent 3 may be any so-called self-expanding stent as described above. For example, as the stent 3, one having a shape as shown in FIG. 28 (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.

  Incidentally, the shape of the stent is not limited to that shown in FIG. 28, for example, a trapezoidal cutout is formed at both ends, and a plurality of hexagonal openings are formed in the center in a honeycomb shape, 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 kg / mm ² (22 ° C.), more preferably 8 to 150 kg / mm ^2. Restoring stress (yield stress during unloading) ) Is 3 to 180 kg / mm ² (22 ° C.), more preferably 5 to 130 kg / 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.

As shown in FIGS. 1 to 3, 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 at the proximal end to the distal end of the proximal tube. 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 end side tube 2 is bent as shown in FIG. Then, as shown in FIGS. 3 and 7, the base end side opening 23 is formed obliquely so as to incline toward the base end side. This facilitates guide wire guidance.
As shown in FIG. 3, 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 350 mm.

The distal end member 25 is located on the distal end side from the distal end of the stent-accommodating tubular member 5 and, as shown in FIG. 3, is formed in a tapered shape that gradually decreases in diameter toward the distal end. preferable. 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 inner 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. 2, 4, and 7, the proximal-side tube 4 is a tube body that penetrates from the distal end to the proximal end, and includes a hub 42 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. Moreover, it is preferable that the outer diameter of a base end side tube is 0.1-2.5 mm smaller than the outer diameter of the intermediate tube mentioned later, and it is especially preferable that it is 0.3-1.5 mm smaller.

  The outer diameter of the proximal end tube is smaller than the outer diameter of the maximum diameter portion on the distal end side from the proximal end tube 4 of the living organ dilator 1. Specifically, in this embodiment, the outer diameter of the fixed portion between the distal end side tube 2 and the proximal end side tube 4 is the maximum outer diameter, and the outer diameter of the proximal end side tube 4 is determined from this outer diameter. Is small. In particular, the outer diameter of the proximal tube is preferably smaller than the outer diameter of the stent housing tubular member 5. Furthermore, in this embodiment, as shown in FIGS. 2, 3 and 7, the distal end portion of the proximal end side tube 4 is connected to the proximal end portion of the distal end side tube 2, and the central axis of the proximal end side tube 4 is It fixes so that it may shift | deviate from the center axis | shaft of the side tube 2 in the direction away from the base end side opening 23. FIG. For this reason, the guide wire extending from the base end side opening 23 is placed along the outer surface of the base end side tube 4 that is an extension of the base end side opening 23, thereby providing a base end side of the biological organ dilator 1 including the guide wire. The outer diameter can be reduced, the operability of the guide wire in the guiding catheter used at the time of use can be improved, and the guiding catheter having a small diameter can be used.

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, it is preferable to use a material having relatively high rigidity as a material for forming the proximal end side tube. 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.

  And in the living organ dilator 1 of this embodiment, the proximal end side of the distal end side tube 2 and the proximal end side of the stent housing tubular member 5 are encapsulated, and the proximal end portion of the distal end side tube 2 is surrounded by the proximal end portion. And an intermediate tube 7 fixed to the distal end portion of the proximal end side tube 4. In the living body organ dilator 1 of this embodiment, the intermediate tube 7 is encapsulated without restricting the movement of the stent housing tubular member 5 toward the proximal end, and one end of the pulling wire 6 Is fixed to the tubular member for housing the stent in the intermediate tube 7, and the pulling wire 6 extends between the intermediate tube 7 and the distal tube 2 and into the proximal tube 4. .

The proximal end portion of the distal tube 2 extends through the intermediate tube 7, and the proximal end portion is exposed from the proximal end of the intermediate tube. Further, the distal end portion of the proximal end side tube 4 penetrates into the proximal end portion of the intermediate tube 7. The distal end side tube 2, the proximal end side tube 4 and the intermediate tube 7 are fixed in a liquid-tight manner at the proximal end portion of the intermediate tube 7. In addition, the lumen 41 of the proximal end side tube 4 communicates with the inside of the intermediate tube 7. Further, the distal end portion of the intermediate tube 7 is reduced in diameter or curved as shown in FIGS. The distal end of the intermediate tube 7 is preferably in liquid-tight contact with the outer surface of the stent-accommodating tubular member 5 without restricting its movement, but it may not be in contact.
The material for forming the intermediate tube is preferably a material having hardness and flexibility, such as polyolefins such as polyethylene and polypropylene, fluoropolymers such as nylon, polyethylene terephthalate, and ETFE, and PEEK (polyether ether). Ketone), polyimide, and the like can be preferably used. In particular, among the above resins, a resin having thermoplasticity is preferable. The outer surface of the intermediate 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.

The living organ dilator 1 has one end fixed to the stent-accommodating tubular member 5 and extends through the proximal-side tube 4 and is pulled toward the proximal end of the proximal-side tube. A pulling wire 6 for moving the shaped member 5 to the proximal end side is provided.
In the living organ dilator 1 of this embodiment, the pulling wire 6 is constituted by a pulling wire. Further, as shown in FIGS. 1, 2, and 4, 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.

  Further, in the living organ dilator 1 of this embodiment, the protrusion 8 that can advance into the slit 52 of the stent-containing tubular member 5 is provided on the outer surface of the proximal end of the distal tube 2. The distal end of the protruding portion 8 is located in the proximal end portion of the slit 52 and restricts the rotation of the stent housing tubular member 5 with respect to the central axis when the living organ dilator 1 is operated. Since the slit 52 extends to the distal end side as described above, the slit 52 moves toward the proximal end side of the stent housing tubular member 5 without restricting the movement of the stent housing tubular member 5 toward the proximal end side. Induces a linear movement of The protruding portion 8 is fixed to the outer surface of the distal tube 2, but may be fixed to the inner surface of the intermediate tube 7, and further provided to extend from the distal end of the proximal tube to the distal side. It may be. The living organ dilator 1 according to this embodiment includes a movement distance regulating unit that regulates the movement distance of the stent-accommodating tubular member toward the proximal end side. Specifically, the protrusion 8 abuts on the distal end of the slit 52 by moving the stent housing tubular member 5 to the proximal end side, and further moves toward the proximal end side of the stent housing tubular member 5. Regulate the movement of

Further, the living organ dilator 1 of this embodiment includes a pulling wire position holding member that is located on the outer surface side of the distal tube 2 and has a passage through which the pulling wire 6 can pass. In particular, in this embodiment, a tubular member 8 is provided that exhibits the functions of both the pulling wire position holding member and the above-described protrusion. By providing such a pulling wire position holding member 8, the pulling wire 6 can be pulled satisfactorily. The pulling wire position holding member 8 is preferably located on the proximal end extension of the fixing portion 68 of the pulling wire 6 with the stent housing tubular member 5. The pulling wire position holding member may be any member that has a passage through which the pulling wire 6 can pass, and may be a ring-shaped member, a ring-shaped member having a notch, a hook-shaped member, or the like. When using said ring-shaped member, it is preferable to provide two or more.
As the tubular member 8, a tube body having a lumen larger than the outer diameter of the pulling member is used. The cylindrical member 8 has a length of 10 mm to 180 mm, more preferably 15 to 120 mm, an outer diameter of 0.15 to 0.8 mm, preferably 0.2 to 0.5 mm, and an inner diameter of The outer diameter of the pulling member is preferably larger by about 0.05 to 0.2 mm.

The pulling wire position holding member is also preferably fixed to the outer surface of the distal tube 2, but may be fixed to the inner surface of the intermediate tube 7, and further from the distal end of the proximal tube. It may be provided so as to extend to the side. Further, the inner surface of the pulling wire position holding member may be coated with a low-friction resin that increases the lubricity as described above.
As shown in FIGS. 1, 4, and 8 to 10, the living organ dilator 1 of the present invention includes a proximal end of the proximal end side tube 4, specifically, a proximal end of the proximal end side tube 4. The operation unit 9 is fixed to a hub 42 provided in the main body.

The operation unit 9 in the living organ dilator 1 includes a wire winding amount regulating mechanism in addition to the pulling wire winding mechanism. Furthermore, in the operation part 9 in the living organ dilator 1 of this embodiment, the lock mechanism for releasably locking the pulling wire winding mechanism and the pulling wire winding function in the direction opposite to the winding direction of the pulling wire. A reverse rotation restricting mechanism for restricting rotation is provided.
The operation unit 9 includes an operation unit housing 91. The operation unit housing 91 includes a housing body 91a and a lid member 91b that seals an opening of the housing body 91a. A connector 93 for connecting to the hub 42 is fixed to the distal end portion of the operation portion housing 91. The housing 91 has a pulling wire passage 97 extending inward from the tip of the tip. And the connector 93 is being fixed to the front-end | tip part of the operation part housing 91 by the fixing member 96 so that the internal channel | path may be connected with the pulling wire channel | path 97. FIG.

As shown in FIGS. 4, 8, and 11, the connector 93 has a hollow connector body 93a, a connection port 93b extending from the connector body 93a, and a seal that holds the puller wire 6 in a slidable and liquid-tight manner. A member 93d is provided. The connection port 93 b is attached to the proximal end portion of the hub 42 of the proximal end side tube 4. The connector 93 may include a side port that communicates with the inside of the connector body.
As the constituent material of the operation unit housing 91, the connector 93, and the hub 42, a hard or semi-hard material is used. Hard or semi-rigid materials include polycarbonate, polyolefin (for example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer), styrene resin [for example, polystyrene, MS resin (methacrylate-styrene copolymer), MBS resin (methacrylate). -Butylene-styrene copolymer)], synthetic resins such as polyester, metals such as stainless steel, aluminum or aluminum alloys can be used.
The housing 91 is provided so as to enclose the pulling wire passage 97 and includes a wire protection tube 95 that protrudes from the proximal end of the pulling wire passage 97 and extends into the housing. The wire protection tube 95 is made of a flexible or elastic material.

  As a constituent material of the sealing member 93d and the wire protection tube 95, an elastic material is used. Examples of elastic materials include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, rubbers such as natural rubber such as latex rubber, olefin elastomers (eg, polyethylene elastomer, polypropylene elastomer), polyamide elastomers, and styrene elastomers (eg, , Styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), synthetic resin elastomers such as polyurethane, urethane elastomer, and fluororesin elastomer.

  As shown in FIG. 8, the housing main body 91a is engaged with an opening 98 for partially projecting the operation rotary roller 61, and with a protrusion of the gear portion 62 provided on the roller 61 as shown in FIG. A locking rib 99 and a bearing portion 94b for accommodating one end 64b of the rotating shaft of the roller 61 are provided. The lid member 91 b includes a bearing portion 94 a that houses the other end 64 a of the rotation shaft of the roller 61. The locking rib 99 has a shape that can enter between the protrusions formed on the gear portion 62 of the roller 61. Further, as shown in FIGS. 9 and 10, the bearing portions 94a and 94b are oval shapes that house one end 64b and the other end 64a of the rotation shaft of the roller 61 and extend in a direction away from the locking rib 99 described above. It has become a shape. The bearing portions 94a and 94b are not limited to an oval 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 a rectangle, an ellipse, or the like, or may be a bowl shape as in the operation unit 100 in the embodiments described later. In particular, in this embodiment, as shown in FIGS. 9 and 10, the bearing portions 94a and 94b are formed to extend in parallel with the rotation axis of the roller 61 and downward (in the vertical direction of the opening 98). In addition, the roller 61 has a length capable of moving a distance equal to or higher than the height of the locking rib 99.

  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. 10, the proximal end portion of the pulling wire 6 includes an anchor portion 60 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 60 is located outside the base end of the slit 63a. Thereby, when the winding shaft portion 63 rotates, the wire 6 is wound around the outer surface thereof as shown in FIG. 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. For this reason, by rotating the rotating roller 61, the winding shaft portion 63 also rotates simultaneously. 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 5 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 operation rotating roller portion, the winding amount of the pulling wire is smaller than the rotating operation amount of the rotating 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 9 of this embodiment includes a lock mechanism that releasably locks the rotation of the pulling wire winding mechanism, 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. 4, 8 to 11, the operation rotating roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Further, the operation rotating roller 61 is partially exposed from the opening 98, and this portion becomes an operation portion. The rotating roller includes the other end 64a of the rotating shaft provided on one side surface and one end 64b of the rotating shaft provided on the other side surface (specifically, the side surface of the winding shaft). Further, the housing 91 is provided with a biasing means 92 that biases the rotary roller 61 toward the opening 98 of the housing. Specifically, the roller 61 is urged by the urging member 92 b of the urging means 92. Further, the housing main body 91a is provided with a locking rib 99 that can enter between the protrusions of the gear portion 62 of the rotating roller 61 biased by the biasing member 92b. For this reason, the rotating roller 61 is in a state shown in FIG. 11 when biased by the biasing member 92b, and the locking rib 99 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 99, specifically, in the direction of the arrow shown in FIG. 12, one end 64b and the other end 64a of the rotary shaft of the rotary roller are provided in the housing 91. The bearings 94a and 94b are moved to a state shown in FIG. In this state, the locking rib 99 is rotatable because the engagement with the protrusion of the gear portion 62 is released. Therefore, the operation unit 9 of this embodiment regulates 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 urging means 92 having the urging member 92b and the gear portion 62 described above restrict the rotation of the traction wire winding function in the direction opposite to the winding direction of the traction wire. A reverse rotation restricting mechanism is configured. The urging unit 92 includes an urging member 92 b and a fixing member 92 a that fixes the urging member 92 b to the housing 91. The urging member 92b extends from the fixed member 92a to the lower side of the gear portion from the rear of the gear portion 62 (in the opposite direction to the tip portion of the operation portion), and the lower protrusion portion and the tip of the gear portion 62 are engaged. A leaf spring extending so as to match is used. Since the leaf spring contacts the lower portion of the gear portion 62, the roller 61 is urged toward the housing opening 98 as described above. Then, as described above, by pressing the roller 61 to bring it into the state shown in FIG. 11, the roller can be rotated. However, as shown in FIG. Although the rotation is possible, if the roller 61 is to be rotated in the reverse direction, the protrusion of the gear portion 62 and the tip of the urging member 92b are engaged to prevent the rotation. Thus, a reverse rotation restricting mechanism for restricting rotation of the pulling wire winding function in the direction opposite to the winding direction of the pulling wire is configured. As a material for forming the leaf spring as the urging member, any material can be used as long as it can exhibit spring elasticity. For example, metal (specifically, steel for spring) and synthetic resin can be used.
Further, the outer diameter of the gear portion 62 is preferably about 10 to 60 mm, particularly preferably 15 to 50 mm, and the number of teeth is preferably about 4 to 200, and particularly preferably 4 to 70.

The living organ dilator 1 according to this embodiment includes a wire winding amount regulating mechanism as shown in FIGS. 1, 4, 8, 10 to 13. The wire winding amount regulating mechanism in this embodiment is configured by a linear body 71 having a predetermined length with one end 71b gripped by the operating portion, and the other end 71a of the linear body 71 is an operation rotating roller. 61 is fixed to a take-up shaft portion 63 or a linear body take-up shaft portion (not shown) provided separately from the take-up shaft portion, and by rotating the operation rotating roller 61 in the wire take-up direction, After the linear body 71 is wound on the winding shaft portion 63 or the linear body winding shaft portion by a predetermined amount, it cannot be wound further.
Specifically, the operation unit 9 holds the one end 71b of the linear body 71 and accommodates the linear body bobbin 73 around which the linear body 71 is wound in a rotatable manner. As shown in the example shown in FIG. 27, the linear body bobbin 73 includes a rotating shaft having two end portions 73a and 73b, and is rotatable by this rotating shaft. Further, the bobbin 73 includes an annular groove 74 for winding the linear body and a groove or hole 75 communicating with the annular groove. Further, the other end 71 a of the linear body 71 is gripped by the winding shaft portion 63 of the operation rotating roller 61. Specifically, the other end 71a of the linear body is inserted into a slit 72 (see FIG. 10) provided in the operation rotating roller 61, and the bulging portion is larger than the width of the slit 72. Grasped.

For this reason, as shown in FIGS. 12 and 13, when the operation rotating roller 61 is rotated in the winding direction of the pulling wire 6, the pulling wire held by the winding shaft portion 63 is wound and the winding wire is wound. The linear body 71 held by the take-up shaft portion 63 is also taken up. As the winding of the linear body 71 progresses, the linear body bobbin 73 rotates, and when all the linear bodies wound around the bobbin are sent out, the bobbin cannot be rotated, and the rotation of the operation rotating roller is further increased. Is impossible. For this reason, the excessive pulling of the pulling wire is not performed.
In this embodiment, the linear body 71 is wound around the winding shaft portion 63. However, the present invention is not limited to this, and the operation is performed separately from the winding shaft portion 63. It is good also as what provides a linear body winding shaft part in the rotary roller 61, and winds up a linear body to this.

The winding effective length of the linear body 71 (in other words, the length that can be wound around the shaft portion of the operation rotating roller) is preferably slightly longer than the axial length of the stent. Moreover, if the linear body 71 is also taken up by the take-up shaft portion 63 that takes up the pulling wire as in the illustrated embodiment, the amount of winding of both of them with respect to the rotation of the operation rotating roller is the same, The effective winding length of the linear body can be easily set.
Moreover, as a forming material of the linear body 71, any material can be used as long as it is difficult to break, and it is preferable that it is difficult to stretch. Examples of such a material include stainless steel wire (preferably, high-strength stainless steel for springs), piano wire (preferably, piano wire with nickel plating or chrome plating), superelastic alloy wire, Ni -Wires made of various metals such as Ti alloy, Cu-Zn alloy, Ni-Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, cobalt alloy, tantalum, polyamide, polyimide, ultra high molecular weight polyethylene, polypropylene, A relatively high-rigidity polymer material such as a fluorine-based resin or a combination of these may be used.

The wire winding amount regulating mechanism is not limited to the above-described embodiment as long as the wire length pulled by the pulling wire winding mechanism is regulated. The wire winding amount regulating mechanism of the type described above regulates the rotatable amount of the operation rotating roller. Such a type of wire winding amount regulating mechanism may be a living organ dilator 100 shown in FIGS.
The wire winding amount regulating mechanism in the operation unit 9 of the living organ dilator 100 includes a protruding portion 81 provided on the operation rotating roller 61 and a predetermined amount of wire wound by the operation rotating roller 61 provided in the operation unit 9. It is configured by a locking portion 82 that abuts after rotating in the taking direction and restricts the further rotation of the operation rotating roller 61.
In the operation portion 9, when the operation rotating roller 61 is rotated in the direction of the arrow shown in FIG. 23, the pulling wire 6 is wound up. Is unable to rotate, and any further pulling wire cannot be wound. Also in this operation part, the wire length pulled by the pulling wire winding mechanism is regulated. This operation unit also regulates the rotatable amount of the operation rotary roller.

Furthermore, the protrusion 81 in the wire winding amount regulating mechanism of this embodiment can adjust the arrangement position of the operation rotary roller 61. For this reason, the rotatable amount of the operation rotating roller 61 can be adjusted. Specifically, a plurality of recesses 84 are provided on the surface of the operation rotating roller 61. In particular, in the embodiment shown in the figure, the plurality of recesses 84 are arranged at equal intervals. And the protrusion part 81 is attached to this recessed part 84 so that attachment or detachment is possible. For this reason, the recessed part of arbitrary positions can be selected, and, thereby, the rotatable amount of the operation rotating roller can be adjusted.
In the above-described embodiment, the protruding portion 81 is provided on the annular outer surface of the operation rotating roller so as to extend in a direction protruding from the annular outer surface, but may be provided on a flat plate surface. In this case, the locking portion is provided at a position corresponding to the protruding portion.

Further, the operation unit may be as shown in FIGS.
FIG. 24 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to another embodiment of the present invention. FIG. 25 is a rear view of the vicinity of the operation unit of the biological organ dilator shown in FIG. FIG. 26 is an explanatory diagram for explaining an internal structure in the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 27 is an explanatory diagram for explaining the internal structure in the vicinity of the operation unit of the living organ dilator shown in FIG.
The basic configuration of the operation unit 200 in the living organ dilator of this embodiment is the same as the operation unit 9 described above. The main differences are the shape of the housing 201, the arrangement position of the winding shaft portion 63 and the gear portion 62 with respect to the operation rotating roller 61, the collar member 102, and the point that the operation portion 200 is provided with a seal member 88. This is a point having the linear body bobbin storage portion 202.

As shown in FIGS. 24 to 27, the operation unit 200 includes an operation unit housing 201. The operation portion housing 201 is bent and rounded at the base end side and the central portion, so that it is easy to grip and to operate the roller in the gripped state.
A connector 93 is fixed to the proximal end of the proximal end side tube 4. Further, the connector 93 includes a seal member 93 d that holds the pulling wire 6 in a slidable and liquid-tight manner. Further, the proximal end portion of the proximal end side tube 4 protrudes from the proximal end portion of the connector 93 and is fixed in a liquid-tight manner by a seal member 88 disposed in the operation portion 200 as shown in FIG. The proximal end of the proximal tube 4 passes through the seal member 88. In addition, you may provide a wire protection tube similarly to the operation part 9 mentioned above. And the operation part housing 201 is provided with the connector mounting part in the front-end | tip part, and as shown in FIG. 26, while the base end side part of the connector 93 is accommodated in the connector mounting part, it is being fixed.

  The constituent materials of the operation unit housing 201 and the connector 93 are the same as those described above. An elastic material is used as a constituent material of the seal member 88, the seal member 93d, and the wire protection tube. Examples of elastic materials include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, rubbers such as natural rubber such as latex rubber, olefin elastomers (eg, polyethylene elastomer, polypropylene elastomer), polyamide elastomers, and styrene elastomers (eg, , Styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), synthetic resin elastomers such as polyurethane, urethane elastomer, and fluororesin elastomer.

  The housing 201 has an opening for partially projecting the operation rotary roller 61 as shown in FIGS. 24 to 27, and a projection of a gear portion 62 provided on the roller 61 as shown in FIG. A locking rib 99 to be engaged, 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 99 has a shape that can enter between the protrusions formed on the gear portion 62 of the roller 61. As shown in FIGS. 24 and 25, the bearing portions 94 a and 94 b accommodate the one end 64 b and the other end 64 a of the rotating shaft of the roller 61 and extend in a direction away from the locking rib 99 described above. 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 200 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. This state of the roller 61 is indicated by a broken line in FIG. 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. 26 and 27, the operation unit 200 includes a collar member 102. The collar member 102 accommodates the take-up shaft portion 63 and has a collar portion 104 that forms an annular space with the take-up shaft portion 63. The collar portion 104 prevents the pulling wire wound around the winding shaft portion 63 from loosening. The collar member 102 also has a function of suppressing movement of the rotating roller when it is pressed and suppressing rattling of the rotating roller. The collar member 102 is pivotally supported by a pin 103. For this reason, as shown in FIGS. 24 and 25, the bearing portions 94a and 94b are formed in a gentle arc shape centering on the pin 103, and the roller 61 is equal to or higher than the height of the locking rib 99. It has the length which can move this distance. Further, as shown in FIG. 27, the collar member 102 includes two notch portions 105 that face each other and reach the space in the collar portion 104 from the side surface. The pulling wire 6 passes through one cutout portion 105 and is fixed to the winding shaft portion 63. The linear body 71 passes through the other cutout portion 105 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. 23, the proximal end portion of the pulling wire 6 is provided with an anchor portion 60 formed larger than the wire 6, and the winding shaft portion 63 accommodates the pulling wire 6. A possible slit 63a is provided. And the base end part of the pulling wire 6 is accommodated in the slit 63a of the winding shaft part 63 so that the anchor part 60 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 FIG. 24, the winding shaft portion 63 is provided on one side surface side of the rotating roller 61. Then, by rotating the rotating roller 61, the winding shaft portion 63 also rotates at the same time. And it is preferable that the winding amount of a pulling wire is small compared with the rotation operation amount of a rotating roller. By doing so, it is possible to take up slowly, and the movement of the stent-accommodating tubular member 5 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.

The winding shaft portion 63 holds or fixes the other end of the linear body 71. Specifically, as shown in FIGS. 26 and 27, the other end portion of the linear body 71 is provided with a bulging portion (in other words, an anchor portion) 71a formed larger than the linear body 71. The winding shaft portion 63 is provided with a slit 72 that can accommodate the linear body 71. The other end portion of the linear body 71 is accommodated in the slit 72 so that the anchor portion 71 a is positioned outside the base end of the slit 72. Thereby, the linear body 71 is wound around the outer surface of the winding shaft portion 63 by rotating the winding shaft portion 63. Note that the gripping or fixing of the linear body 71 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 linear body 71 to a winding shaft part directly.
In addition, it is preferable that the portion of the linear body 71 to be wound is flexible in order to facilitate winding. Such a flexible method may be performed by a method of forming a portion where the linear body 71 is wound with a flexible material, a method of reducing the diameter of the portion where the linear body 71 is wound, or the like. it can.

In this embodiment, the winding shaft portion 63 is integrated with the rotating roller 61 so as to be coaxial. Further, as shown in FIG. 24, the winding shaft portion 63 is provided on one side surface side of the rotating roller 61. Then, by rotating the rotating roller 61, the winding shaft portion 63 also rotates at the same time. And it is preferable that there is little winding amount of a linear body compared with the amount of rotation operations of a rotating roller. By doing so, it is possible to perform a slow winding.
In this embodiment, the linear body 71 is wound around the winding shaft portion 63. However, the present invention is not limited to this, and the operation is performed separately from the winding shaft portion 63. It is good also as what provides a linear body winding shaft part in the rotary roller 61, and winds up a linear body to this.

Further, the operation unit 200 includes a linear body bobbin storage unit 202. The bobbin storage portion 202 is a cylindrical projecting portion provided on the inner surface of the operation unit housing 201, and stores the linear body bobbin in a rotatable manner. Further, the bobbin storage portion is provided with a slit 202a for inserting a linear body. By having such a bobbin storage portion, the linear body 71 wound around the bobbin 73 can be prevented from loosening. As shown in FIG. 27, the bobbin 73 includes an annular groove 74 for winding the linear body and a groove or hole 75 communicating with the annular groove.
The operation unit 200 according to this embodiment includes a lock mechanism that locks the rotation of the pulling wire winding mechanism so as to be releasable, and a reverse rotation that restricts rotation of the pulling wire winding function in the direction opposite to the winding direction of the pulling wire. A regulation mechanism is provided.
As shown in FIGS. 24 and 25, the operation rotating roller 61 includes a gear portion 62 provided so as to rotate coaxially and integrally. Further, as shown in FIG. 25, 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 201 is provided with a biasing means 92 that biases the rotating roller 61 toward the opening of the housing. Specifically, the roller 61 is urged by the urging member 92 b of the urging means 92. Further, the housing 201 is provided with a locking rib 99 that can enter between the protrusions of the gear portion 62 of the rotating roller 61 biased by the biasing member 92b. For this reason, the rotating roller 61 is in a state shown in FIG. 25 when biased by the biasing member 92b, and the locking rib 99 engages with the protruding portion of the gear portion 62, and thus cannot rotate. . When the rotating roller 61 is pushed away from the locking rib 99, the one end 64b and the other end 64a of the rotating shaft of the rotating roller can move and rotate in bearings 94a and 94b provided in the housing 201. Become. Therefore, the operation unit 200 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 urging means 92 having the urging member 92b and the gear portion 62 described above restrict the rotation of the traction wire winding function in the direction opposite to the winding direction of the traction wire. A reverse rotation restricting mechanism is configured. The urging unit 92 includes an urging member 92 b and a fixing member 92 a that fixes the urging member 92 b to the housing 201. The urging member 92b extends from the fixed member 92a to the lower side of the gear portion from the rear of the gear portion 62 (in the opposite direction to the tip portion of the operation portion), and the lower protrusion portion and the tip of the gear portion 62 are engaged. A mating spring-like member is used. Since this spring-like member abuts against the lower portion of the gear portion 62, the roller 61 is urged toward the opening of the housing as described above. 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 FIGS. 23 and 25 (direction in which the pulling wire is wound), if the roller 61 is rotated in the opposite direction, the protrusion of the gear portion 62 and the urging member 92b. The tips of the two engage and prevent its rotation. Thus, a reverse rotation restricting mechanism for restricting rotation of the pulling wire winding function in the direction opposite to the winding direction of the pulling wire is configured.
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.

Further, in the operation unit 200, as shown in FIG. 24, the urging member 92b enters between the inner surface of the housing 201 and the side surface of the rotating roller 61, and the tip thereof contacts the gear unit 62. . For this reason, the lateral movement (horizontal direction) of the urging member 92 b is restricted by the inner surface of the housing 201 and the side surface of the rotating roller 61.
The collar member 102 included in the operation unit 200 has one end portion pivotally supported by the pin 103, and the collar portion 104 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 the operation rotating roller 61 of the operation unit 9 is pressed, the roller is rotated in the direction of the arrow in FIG. As a result, the pulling wire 6 is wound around the outer peripheral surface of the winding shaft portion 63, and the stent housing tubular member 5 moves to the proximal end side . As shown in FIG. emitted from the distal end opening of the use cylindrical member 5, also, the small diameter portion of the stent-containing tubular member 5, Ru is housed in the intermediate tube 7. This release, the stent 3, as shown in FIG. 1 4, is placed in the stenosis with expanding the self-dilated stenosis. Further, by rotating the roller in the direction of the arrow in FIG. 13, the linear body 71 is also wound around the winding shaft portion 63, and after the winding amount of the linear body 71 is wound, the rotation of the roller 61 is performed. Operation becomes impossible.

Next, a living organ dilator 10 according to another embodiment of the present invention will be described.
FIG. 15 is a partially omitted enlarged external view of a living organ dilator according to another embodiment of the present invention. FIG. 16 is an enlarged cross-sectional view of the vicinity of the distal end portion of the living organ dilator shown in FIG. FIG. 17 is an explanatory diagram for explaining the operation of the living organ dilator shown in FIG.
The difference between the living organ dilating instrument 10 of this embodiment and the living organ dilating instrument 1 of the above-described embodiment is that the intermediate tube is not provided and the shape of the distal end tube is different. About the thing which is the same as the expansion instrument 1 and attached | subjected the same code | symbol, it is the same as what was mentioned above.
The living organ dilator 10 of this embodiment includes a distal end side tube 2a, a proximal end side tube 4, a stent housing tubular member 5a, a stent 3 and a pulling wire 6.

As shown in FIGS. 15 and 16, the tubular member 5 a for housing the stent is a tubular member having substantially the same outer diameter as a whole. Further, a slit 59 as shown in FIG. 21 may be provided in the stent-accommodating tubular member 5a. In this slit 59, as shown in FIG. 21, a protrusion 29 formed on the outer surface of the distal tube can be advanced. In this embodiment, the stent housing tubular member 5a is movable to the proximal end side until the distal end side end portion of the slit 59 abuts against the projection portion 29. Therefore, the slit 59 is equal to or slightly longer than the length from the proximal end of the stent 3 to the distal end of the stent housing tubular member 5a in the stent housing tubular member 5a housing the stent 3.
As a forming material of the stent-housing tubular member 5a, the same material as the stent-housing tubular member 5 described above is used. Moreover, it is preferable to perform the process for exhibiting lubricity to the outer surface of the cylindrical member 5a for stent accommodation. Such processing is as described above. Furthermore, in order to make the slidability of the stent 3 favorable on the inner surface of the stent-accommodating tubular member 5a, the above-mentioned ones may be coated or fixed.
And the stent 3 is accommodated in the front-end | tip part of the cylindrical member 5a for stent accommodation. The stent 3 is the same as described above.

As shown in FIGS. 15 to 16, the distal end side tube 2a is a tube body having a guide wire lumen 21 penetrating 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 2a is fixed at the distal end of the proximal tube at the proximal end. Further, the guide wire lumen 21 is bent at the proximal end portion, and is provided with a proximal end side opening 23 at the proximal end portion (the proximal end in this embodiment) of the distal end side tube 2a. And the base end side opening 23 is diagonally formed so that it may incline toward the base end side, as shown in FIG. This facilitates guide wire guidance.
The distal tube 2a has an outer diameter of 0.5 to 3.0 mm, preferably 1.0 to 2.5 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 350 mm.

Further, as shown in FIG. 16, the distal end side tube 2a includes a small diameter portion 26 for stent placement at the distal end portion. The proximal end 26a of the stent placement small diameter portion 26 constitutes a stent locking portion that restricts the movement of the in-body cavity placement stent 3 toward the proximal end. The outer diameter of the proximal end 26a of the stent placement small-diameter portion 26 is such that it can contact the proximal end of the compressed stent 3. Even if the stent-accommodating tubular member 5a moves to the proximal end side, the stent 3 is maintained in position by the proximal end 26a, and thus is eventually released from the stent-accommodating tubular member 5a.
Also in the living organ dilator 10 of this embodiment, the outer diameter of the proximal end tube is smaller than the outer diameter of the maximum diameter portion on the distal end side of the proximal end tube 4 of the living organ dilator 10. Yes. Specifically, the outer diameter of the stent-accommodating tubular member 5a is the maximum outer diameter, and the outer diameter of the proximal tube 4 is smaller than this outer diameter. Further, in this embodiment, as shown in FIGS. 15 and 16, the distal end portion of the proximal end side tube 4 is located at the proximal end portion of the distal end side tube 2a and the central axis of the proximal end side tube 4 is aligned with the distal end side tube 2a. It is being fixed so that it may shift | deviate from the center axis of this to the direction spaced apart from the base end side opening 23. FIG.

Further, the distal tube 2a includes a traction wire passage 27 that extends from the vicinity of the fixing portion 61 of the traction wire 6 to the stent housing tubular member 5a to the proximal end side and through which the traction wire passes. In this embodiment, the pulling wire passage 27 is formed by a recess extending in the axial direction provided on the outer surface of the distal tube 2a. The pull wire passage may be a lumen extending within the thickness of the distal tube 2a.
Also in the living organ dilator 10 of this embodiment, the stent storage tubular member 5a moves to the proximal end side in the axial direction by operating the rotating roller 61 of the operating portion 9 of the pulling wire 6. At this time, since the rear end surface of the stent 3 is brought into contact with and locked to the proximal end surface of the small diameter portion of the distal tube 2a, the distal end of the stent housing tubular member 5a is moved along with the movement of the stent housing tubular member 5a. Released from the opening. By this release, as shown in FIG. 17, the stent 3 is self-expanded to expand the stenosis and is placed in the stenosis.

In all the embodiments described above, a plurality of pulling wires, specifically, two pulling wires may be provided.
The living organ dilator 20 according to the embodiment shown in FIGS. 18 to 20 includes two pulling wires.
FIG. 18 is a partially omitted enlarged external view of a living organ dilator according to another embodiment of the present invention. 19 is an enlarged cross-sectional view taken along line EE in FIG. 20 is an enlarged cross-sectional view taken along line FF in FIG.
The difference between the living organ dilating instrument 20 of this embodiment and the living organ dilating instrument 1 of the above-described embodiment is only the point that two pulling wires are provided and the difference resulting therefrom, and the others are described above. The same components as those of the living organ dilator 1 and denoted by the same reference numerals are the same as those described above. Note that two pulling wires may be provided also in the above-described living organ dilator 10.

As shown in FIGS. 18 and 19, the tubular member 5 for accommodating a stent in the living organ dilating instrument 20 of this embodiment extends from the proximal end to the distal end side and is provided with two slits 52 a provided at opposing positions. 52b. In order to correspond to this, the distal tube 2 is provided with two tubular members 8a and 8b arranged at opposing positions.
Two pull wires 6a and 6b are fixed to the proximal end portion of the stent-accommodating tubular member 5 at opposite positions. 18 to 20, the pulling wire 6a passes through the tubular member 8a, extends through the proximal end side tube 4, and is fixed to the operation member 62 at the proximal end portion. Similarly, the pulling wire 6b penetrates the tubular member 8b, extends in the proximal end side tube 4, and is fixed to the winding shaft of the operation portion 9 at the proximal end portion. When two pulling wires 6a and 6b are used, the two wires may be integrated at the base end portion. In addition, by using two pulling wires, the pulling can be performed straight without bending.

Further, in the living organ dilating instrument of the present invention, if the living organ dilating instrument is provided with a pulling wire position holding member that is located on the outer surface side of the distal end side tube and has a passage through which the pulling wire can penetrate, traction is performed. Wire pulling is good.
Further, in the living organ dilator according to the present invention, the living organ dilator has a protrusion positioned on the outer surface side of the distal tube, and the cylindrical member for accommodating the stent extends from the proximal end to the distal end and protrudes. If it has the slit which can advance, the movement to the base end side of the cylindrical member for stent accommodation will become favorable.
The pulling wire winding mechanism is not limited to the above-described configuration as long as the wire can be wound. The lock mechanism for releasably locking the pulling wire winding mechanism may be any mechanism that can lock the pulling wire winding mechanism so that the rotation can be released. It is not limited to. The reverse rotation restricting mechanism that restricts the rotation of the pulling wire winding function in the direction opposite to the winding direction of the pulling wire may be any as long as it prevents rotation in the reverse direction. It is not limited to the thing of a structure.

  In all the above-described embodiments, a rigidity imparting body (not shown) may be inserted into the proximal end side tube 4. It is preferable that the rigidity imparting body is fixed to the proximal end side tube at the proximal end portion, and the distal end protrudes from the distal end of the proximal end side tube and extends into the distal end side tube. Moreover, it is preferable that only the base end portion of the rigidity imparting body is fixed to the base end side tube, and the other portions are not fixed so as not to obstruct the bending of the living organ dilator. The rigidity imparting body prevents the proximal end side tube from being bent at the bent portion and prevents the proximal end side tube from meandering in the blood vessel without significantly reducing the flexibility of the proximal end side tube. The rigidity imparting body is preferably formed of a linear body. The linear body is preferably a metal wire, and is preferably an elastic metal such as stainless steel having a wire diameter of 0.05 to 1.5 mm, preferably 0.1 to 1.0 mm, a superelastic alloy, etc. Is a high-strength stainless steel for springs and a superelastic alloy wire.

FIG. 1 is a partially omitted front view of a living organ dilator according to an embodiment of the present invention. FIG. 2 is an enlarged external view of the vicinity of the distal end portion of the biological organ dilator shown in FIG. FIG. 3 is an enlarged cross-sectional view of the vicinity of the distal end portion of the living organ dilator shown in FIG. FIG. 4 is an enlarged external view of the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 5 is an external view of an example of a stent-housing tubular member used in the living organ dilating instrument of the present invention. 6 is an enlarged sectional view taken along line AA in FIG. 7 is an enlarged cross-sectional view taken along line BB in FIG. FIG. 8 is an enlarged left side view of the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 9 is an enlarged bottom view of the operation unit of the living organ dilator shown in FIG. 10 is a cross-sectional view taken along the line CC of FIG. 11 is an enlarged cross-sectional view taken along the line DD of FIG. FIG. 12 is an explanatory view for explaining the operation of the living organ dilator according to the present invention. FIG. 13 is an explanatory view for explaining the operation of the living organ dilator according to the present invention. FIG. 14 is an explanatory view for explaining the operation of the living organ dilator according to the present invention. FIG. 15 is a partially omitted enlarged external view of a living organ dilator according to another embodiment of the present invention. FIG. 16 is an enlarged cross-sectional view of the vicinity of the distal end portion of the living organ dilator shown in FIG. FIG. 17 is an explanatory diagram for explaining the operation of the living organ dilator shown in FIG. FIG. 18 is a partially omitted enlarged external view of a living organ dilator according to another embodiment of the present invention. 19 is an enlarged cross-sectional view taken along line EE in FIG. 20 is an enlarged cross-sectional view taken along line FF in FIG. FIG. 21 is an enlarged external view of a distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 22 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to another embodiment of the present invention. FIG. 23 is a left side view of the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 24 is an enlarged front view of the vicinity of the operation unit of the living organ dilator according to another embodiment of the present invention. FIG. 25 is a rear view of the vicinity of the operation unit of the biological organ dilator shown in FIG. FIG. 26 is an explanatory diagram for explaining an internal structure in the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 27 is an explanatory diagram for explaining the internal structure in the vicinity of the operation unit of the living organ dilator shown in FIG. FIG. 28 is a perspective view of an example of a stent for indwelling in a body cavity used in the living organ dilating instrument of the present invention.

Explanation of symbols

1, 10, 20, 100 Biological organ dilator 2 distal end tube 3 stent 4 proximal end tube 5 stent storage tubular member 6 pulling wire 7 intermediate tube 71 linear body 9 operation unit 42 hub

Claims (17)

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 cylindrical member for stent storage in a compressed state, expands outward at the time of in vivo placement, and restores the shape before compression,
Further, the living organ dilator encapsulates a proximal end side of the distal end side tube and a proximal end side of the stent-housing tubular member, and a proximal end portion of the distal end side tube and the proximal end portion It comprises an intermediate tube fixed to the distal end portion of the end side tube, and the intermediate tube is encapsulated without restricting the movement of the stent housing tubular member to the proximal end side,
Further, the pulling wire is wound around the proximal end portion of the proximal tube, and the pulling wire winding mechanism for moving the stent housing tubular member toward the proximal end and the pulling wire winding mechanism A living organ dilator having an operation unit including a wire winding amount regulating mechanism for regulating the length of a wire to be pulled. 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 1, which is wound on the side. The living organ expansion instrument according to claim 1 or 2, 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 1 to 3, wherein the operation unit includes a reverse rotation restricting mechanism that restricts rotation of the pulling wire winding function in a direction opposite to a winding direction of the pulling wire. 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 1 to 4, wherein a base end portion of the pulling wire is fixed to a portion. The wire winding amount regulating mechanism is configured by a linear body having a predetermined length with one end gripped by the operation portion, and the other end of the linear body is the winding shaft portion of the rotating roller for operation. Or a linear body fixed to a linear body take-up shaft portion provided separately from the take-up shaft portion, and by rotating the operating rotary roller in the wire take-up direction, the linear body is The living organ dilator according to claim 5, wherein after the predetermined amount is wound on the winding shaft portion or the linear body winding shaft portion, further winding is impossible. The wire winding amount regulating mechanism includes a linear body bobbin that grips one end of the linear body, is wound around the linear body, and is rotatably accommodated in the storage unit. 6. A living organ dilator according to 6. The wire winding amount regulating mechanism is in contact with a protruding portion provided in the operation rotating roller, and the operation rotating roller provided in the operation portion rotates after a predetermined amount of rotation in the wire winding direction. The living organ dilator according to claim 5, comprising a locking portion that restricts rotation of the operation rotating roller. 9. The protrusion of the wire winding amount regulating mechanism can adjust an arrangement position of the operation rotary roller, and can adjust a rotatable amount of the operation rotary roller. Living organ expansion device. The said operation part is provided with the connector connected to the base end part of the said base end side tube, This connector is provided with the sealing member which the said pulling wire penetrates liquid-tightly. The living organ dilator described in 1. 7. The living body according to claim 1, wherein the living organ expanding device includes a pulling wire position holding member that is located on an outer surface side of the distal end side tube and has a passage through which the pulling wire can pass. Organ dilator. The living organ dilator has a protrusion located on the outer surface side of the distal tube, and the stent-housing tubular member extends from the proximal end to the distal side and the protrusion can advance. The living organ dilator according to any one of claims 1 to 11. The pulling wire take-up mechanism encloses the take-up shaft portion and the take-up shaft portion, and forms an annular space between the take-up shaft portion and the take-up shaft portion. The living organ dilator according to any one of claims 1 to 12, further comprising a collar portion for suppressing loosening of the pulled puller wire. The stent-housing tubular member has a stent-housing site on the distal end side that has a diameter-increased portion, and a proximal-end side that is a small-diameter portion with respect to the enlarged-diameter portion. when the member is moved proximally, the small diameter portion of the stent-containing tubular member is adapted to that received in the intermediate tube, the one end of the puller wire at the said intermediate tube wherein is fixed the stent-containing tubular member, further, the pulling wire, the street as the intermediate tube between the distal-side tube, claims 1 and become a extending in the proximal end side in the tube 13 A living organ dilator according to any one of the above. The living organ dilator according to any one of claims 1 to 14, wherein the distal tube includes a pull wire passage through which the pull wire can penetrate. The said distal end tube is provided with the small diameter part for stent arrangement | positioning formed in the front end side, The said stent latching | locking part is comprised by the base end of this small diameter part for stent arrangement | positioning. The living organ dilator according to any one of the above. The biological organ dilator according to claim 1, wherein two pulling wires are provided.

Images