JP5053885B2 - Biological organ dilator - Google Patents

Description

  The present invention relates to a living organ dilator for improving a stenosis or occlusion occurring in a living body lumen such as a blood vessel, a bile duct, a trachea, an esophagus, or a urethra.

A living organ dilator is generally equipped with a stent for improving a stenosis. In order to treat various diseases caused by stenosis or occlusion of blood vessels or other in-vivo lumens, stents are generally placed in order to expand the stenosis or occlusion site and secure the lumen. Specifically, it is a tubular medical device.
Since the stent is inserted into the body from outside the body, the diameter is small at that time. The stent is expanded at the target stenosis or occlusion site to increase the diameter, and the lumen is held as it is.

  As the stent, a metal wire or a cylindrical shape obtained by processing a metal tube is generally used. It is attached to a catheter or the like in a thin state, inserted into a living body, expanded by a certain method at a target site, and tightly fixed to the inner wall of the lumen to maintain the lumen shape. Stents are classified into self-expandable stents and balloon expandable stents according to function and placement method. The balloon expandable stent has no expansion function in the stent itself. After inserting the stent into the target site, the balloon is positioned in the stent to expand the balloon, and the stent is expanded (plastic deformation) by the expansion force of the balloon. Fix it in close contact with the inner surface of the lumen. This type of stent requires the above-described stent expansion operation.

In the balloon expandable stent, after placing the stent on the folded balloon, the stent is compressed to reduce the diameter and mounted on the balloon. If the stent is not securely attached to the balloon, the stent may be detached during the indwelling operation.
Japanese Patent Laid-Open No. 2007-135880 (Patent Document 1) discloses a stent delivery system in which at least one secondary protrusion of the balloon is sandwiched between the stent struts when the balloon is folded. ing.
Specifically, in the stent delivery system of Patent Document 1, a balloon including a secondary protrusion 1D on the surface is used when folded. When the balloon is folded, it has at least one wing 1E on the surface, and a secondary protrusion 1D is formed on the surface of the wing. Then, by disposing the stent 10 in a contracted state on the outer surface of the folded balloon 1, preferably on the outer surface of the straight tube portion 1A, the secondary protrusion 1D of the balloon can be attached to the stent 10 as shown in FIG. It is sandwiched between stent struts 11.

JP 2007-135880 A

The thing of patent document 1 is considered to be provided with the high detachment | desorption suppression effect from the balloon of a stent. However, a plurality of secondary protrusions of the balloon are held by the struts of the stent, and there is a risk of damaging the balloon when the struts are held.
An object of the present invention is to provide a living organ dilator that sufficiently suppresses the movement and detachment of a stent mounted on a balloon and is less likely to be damaged by the balloon when the stent is mounted.

What achieves the above object is as follows.
(1) A tube-shaped shaft main body, an expandable and folded balloon provided at the tip of the shaft main body, and an expansion of the balloon that is mounted to enclose the folded balloon A living organ expansion device comprising a stent that expands according to
The folded balloon includes a plurality of folds extending in the axial direction of the stent,
The stent is a linear body having a number of linear components extending in the axial direction of the stent, and is attached to the balloon so as to cross the fold of the balloon. All or a plurality of linear components of the plurality of linear components extending in the axial direction include extensions extending in the circumferential direction of the stent, and all or some of the ends of the plurality of extensions are A biological organ dilator that has entered the fold line of the balloon.

(2) In the above (1), the stent gently holds the balloon by the extending portion that has entered under the fold of the balloon and a linear component that crosses over the fold of the balloon. The biological organ dilator described.
(3) Each fold of the balloon is substantially parallel to the central axis of the stent, and the stent is provided with a plurality of extending portions substantially parallel to the central axis of the stent. The living organ dilator as described in (1) or (2) above, wherein a plurality of extending part rows are provided so as to correspond to the respective folds of the balloon.

(4) The living organ dilator according to any one of (1) to (3), wherein the end portion of the extending portion is a curved end having no edge.
(5) The living organ according to any one of (1) to (4), wherein the extending portion is configured such that a part of the linear component bulges in a circumferential direction of the stent. Expansion device.
(6) The extension portion is configured by bending a part of the linear component so as to protrude in a circumferential direction of the stent, according to any one of (1) to (4). Living organ expansion device.

(7) A number of linear components extending in the axial direction of the stent are linear components parallel to the central axis of the stent, and the extending portion is a linear configuration parallel to the central axis of the stent. The living organ dilator according to any one of (1) to (6), which is provided in an element.
(8) A number of linear components extending in the axial direction of the stent are linear components extending obliquely at a predetermined angle with respect to the central axis of the stent, and the extending portion extends to the central axis of the stent. The living organ dilator according to any one of the above (1) to (6), which is provided on a linear component extending obliquely at a predetermined angle with respect to the same.

(9) The stent is formed by a linear body having a large number of linear components extending in the axial direction of the balloon, and a plurality of annular bodies arranged in the axial direction, and between the annular bodies adjacent in the axial direction. The living organ dilator according to any one of (1) to (8), comprising a connecting portion that connects the two.
(10) The living organ dilating instrument according to (9), wherein the extending portion is provided in the annular body.
(11) The extending part is a living organ dilator as described in (9) or (10) provided in the connecting part.
(12) Each annular body connects one end-side bent portion of the plurality of stents, the other end-side bent portion of the plurality of stents, the one end-side bent portion, and the other end-side bent portion, and The living organ dilating instrument according to any one of the above (9) to (11), which is a wavy linear annular body having a linear component extending in the axial direction.
(13) Each of the annular bodies is an annular body in which linear ring portions that are long in the axial direction of the stent are arranged so as to surround the central axis of the plurality of stents, and adjacent linear ring portions are connected at a joint portion. The living organ dilator according to any one of the above (9) to (11), comprising:

The living organ dilator according to the present invention is mounted so as to enclose a tube-shaped shaft main body, an expandable and folded balloon provided at the distal end of the shaft main body, and the folded balloon. And a stent that expands by expansion of the balloon, wherein the folded balloon has a plurality of folds extending in the axial direction of the stent, and the stent is in the axial direction of the stent. A linear body having a plurality of linear components extending in the direction, and mounted on the balloon so as to cross the fold of the balloon, and further extending in the axial direction of the stent. All or a plurality of linear components of the element comprise an extension extending in the circumferential direction of the stent, and all or some of the plurality of extensions Department has invaded the folding presently the balloon.
The stent of the present invention is mounted on the balloon so as to cross the fold of the balloon, and the end of the extended portion provided in the stent penetrates under the fold of the balloon. For this reason, it will be in the state which pushes up slightly the crease | fold part of the balloon which the extension part of the stent penetrate | invaded, and the movement and detachment | leave of the stent with which the balloon was mounted | worn are suppressed. In addition, since the extension portion does not strongly hold the balloon, there is very little possibility that the extension portion that enters under the folding line of the balloon damages the balloon.

The living organ dilator according to the present invention will be described using the following preferred embodiments.
FIG. 1 is a front view of a living organ dilator according to an embodiment of the present invention. FIG. 2 is an enlarged view of the distal end portion of the living organ dilator shown in FIG. FIG. 3 is an enlarged cross-sectional view of the distal end portion of the living organ dilator shown in FIG. FIG. 4 is an enlarged view of the distal end portion of the living organ dilating instrument of the present invention in a state where no stent is attached. FIG. 5 is a partially enlarged view of FIG. 6 is an enlarged cross-sectional view taken along line AA in FIG. FIG. 7 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention. FIG. 8 is a front view of the in-vivo stent of the living organ dilator shown in FIG. FIG. 9 is a development view of the in-dwelling stent of FIG. FIG. 10 is a front view of the in-vivo indwelling stent of FIG. 8 at the time of expansion. FIG. 11 is a development view of the in-vivo indwelling stent of FIG. 8 at the time of expansion. FIG. 12 is a developed view of another example of the in-vivo stent used in the living organ dilating instrument of the present invention.

  The living organ dilator 1 of the present invention encloses a tubular shaft body 2, an expandable and folded balloon 3 provided at the tip of the shaft body 2, and the folded balloon 3. And a stent 10 that is expanded by expansion of the balloon 3. The balloon 3 in a folded state includes a plurality of folds 35 extending in the axial direction of the stent 10. The stent 10 is a linear body having a large number of linear components 18 extending in the axial direction of the stent 10, and is attached to the balloon 3 so as to cross the fold 35 of the balloon 3. All or a plurality of linear components 18 of the plurality of linear components 18 extending in the axial direction of each of the plurality of linear components 18 include an extension portion 15 extending in the circumferential direction of the stent 10. The end portion penetrates under the folding line of the balloon 3. Note that the fold 35 can be rephrased as a wing end, a fold end, or a pleat end. And as a living organ dilator, it is preferable that it is a vascular dilator. The biological organ dilator may be a device that dilates the bile duct, trachea, esophagus, urethra and the like.

The living organ dilator 1 of the present invention encloses a tube-shaped shaft body 2, a foldable and expandable balloon 3 provided at the distal end of the shaft body 2, and a balloon 3 in a folded state. And a stent 10 that is expanded by expansion of the balloon 3.
The stent 10 used in the living organ dilating instrument 1 of this embodiment is formed in a substantially tubular body, has a diameter for insertion into a lumen in a living body, and extends radially from the inside of the stent 10. It is a so-called balloon expandable stent that expands when a force is applied.

The living organ expanding device 1 of this embodiment includes the above-described stent 10 and a tube-shaped living organ expanding device body 5 to which the stent 10 is attached.
The biological organ expanding instrument body 5 includes a tube-shaped shaft body 2 and a foldable and expandable balloon 3 provided at the distal end of the shaft body, and the stent 10 includes the balloon 3 in a folded state. It is mounted so as to be encapsulated and is expanded by expansion of the balloon 3.

In the living organ dilator 1 of this embodiment, as shown in FIG. 3, the shaft body 2 has one end opened at the tip of the shaft body 2 and the other end at the rear end of the shaft body 2. An open guide wire lumen 8 is provided.
The living organ expanding instrument main body 5 includes a shaft main body 2 and a stent expansion balloon 3 fixed to the distal end of the shaft main body 2, and a stent 10 is mounted on the balloon 3. The shaft body 2 includes an inner tube 4, an outer tube 6, and a branch hub 7.

  As shown in FIG. 3, the inner tube 4 is a tube body including a guide wire lumen 8 for inserting a guide wire therein. The inner tube 4 has a length of 100 to 2500 mm, more preferably 250 to 2000 mm, and an outer diameter of 0.1 to 1.0 mm, more preferably 0.3 to 0.7 mm, and a wall thickness of 10 to 10. It is 250 micrometers, More preferably, it is 20-100 micrometers. The inner tube 4 is inserted into the outer tube 6, and a tip portion of the inner tube 4 protrudes from the outer tube 6. A balloon expansion lumen 9 is formed by the outer surface of the inner tube 4 and the inner surface of the outer tube 6, and has a sufficient volume. The outer tube 6 is a tube body in which the inner tube 4 is inserted and the tip is located at a portion slightly retracted from the tip of the inner tube 4.

The outer tube 6 has a length of 100 to 2500 mm, more preferably 250 to 2000 mm, and an outer diameter of 0.5 to 1.5 mm, more preferably 0.7 to 1.1 mm, and a wall thickness of 25 to 25 mm. It is 200 μm, more preferably 50 to 100 μm.
In the living organ dilator 1 of this embodiment, the outer tube 6 is formed by the distal end side outer tube 6a and the main body side outer tube 6b, and both are joined. The distal end side outer tube 6a has a tapered diameter at a portion closer to the distal end than the joint portion with the main body side outer tube 6b, and the distal end side has a smaller diameter than the tapered portion.
The outer diameter at the small diameter portion of the distal end side outer tube 6a is 0.50 to 1.5 mm, preferably 0.60 to 1.1 mm. Moreover, the base end part of the front end side outer tube 6a and the outer diameter of the main body side outer tube 6b are 0.75 to 1.5 mm, preferably 0.9 to 1.1 mm.

The material for forming the inner tube 4 and the outer tube 6 is preferably a material having a certain degree of flexibility. For example, polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, etc.) Further, thermoplastic resins such as polyvinyl chloride, polyamide elastomer and polyurethane, silicone rubber, latex rubber and the like can be used, preferably the above-mentioned thermoplastic resin, more preferably polyolefin.
The balloon 3 has a front end side joint portion 3a and a rear end side joint portion 3b. The front end side joint portion 3a is fixed at a position slightly rear end side from the front end of the inner tube 4, and the rear end side joint portion 3b. Is fixed to the tip of the outer tube. The balloon 3 communicates with the balloon expansion lumen 9 in the vicinity of the proximal end portion.

  As shown in FIGS. 4 and 6, the balloon 3 is foldable. When the balloon 3 is not expanded, the balloon 3 can be folded on the outer periphery of the inner tube 4. In particular, in the living organ dilator 1 of the present invention, as shown in FIGS. 1 to 6, the balloon 3 in a folded state is folded in a plurality (specifically, three) that extend in the axial direction of the stent 10. Eye 35 is provided. In particular, in the illustrated embodiment, each fold 35 of the balloon 3 is substantially parallel to the central axis of the stent 10 to be mounted. The plurality of (specifically, three) folds are preferably formed so as to be substantially equiangular with respect to the central axis of the balloon (stent). That is, the balloon 3 of this embodiment includes three folds 35, which are arranged at intervals of about 120 degrees with respect to the central axis of the balloon (stent). Further, four or more folds may be provided, and in this case as well, each fold is preferably provided so as to be substantially equiangular with respect to the central axis of the balloon (stent). In addition, as a number of folds, about 2-20 are suitable and 3-10 are especially preferable. Further, each fold 35 of the balloon 3 may extend obliquely at a predetermined angle with respect to the central axis of the stent 20 to be mounted, like a living organ dilator 400 shown in FIG. 24 and described later.

Further, as shown in FIGS. 2 to 4, the balloon 3 is an expandable portion having a cylindrical portion (preferably, a substantially cylindrical portion) having substantially the same diameter so that the stent 10 to be mounted can be expanded at the time of expansion. 3c. The substantially cylindrical portion may not be a perfect cylinder, but may be a polygonal column. As described above, the balloon 3 is liquid-tightly fixed to the inner tube 4 at the front end side joining portion 3a and the rear end side joining portion 3b at the tip end of the outer tube 6 by an adhesive or heat fusion. . Moreover, in this balloon 3, the space | interval between an expandable part and a junction part is formed in the taper shape. Then, as shown in FIG. 7, the balloon 3 is expanded by injecting an expansion fluid into the balloon 3 and expands the attached stent 10. Further, the folds of the balloon 3 are substantially lost during expansion.
The balloon 3 forms an expansion space 3 d between the inner surface of the balloon 3 and the outer surface of the inner tube 4. The expansion space 3d communicates with the expansion lumen 9 on the entire periphery at the rear end. Thus, since the rear end of the balloon 3 communicates with the expansion lumen having a relatively large volume, the expansion fluid is surely injected into the balloon from the expansion lumen 9.

As a material for forming the balloon 3, a material having a certain degree of flexibility is preferable. For example, polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate). Copolymer), polyvinyl chloride, polyamide elastomer, polyurethane, polyester (for example, polyethylene terephthalate), thermoplastic resin such as polyarylene sulfide (for example, polyphenylene sulfide), silicone rubber, latex rubber, and the like. In particular, a stretchable material is preferable, and the balloon 3 is preferably biaxially stretched having high strength and expansion force.
As the size of the balloon 3, the outer diameter of the cylindrical portion (expandable portion) when expanded is 2 to 4 mm, preferably 2.5 to 3.5 mm, and the length is 10 to 50 mm, preferably 20-40 mm. Moreover, the outer diameter of the front end side joint portion 3a is 0.9 to 1.5 mm, preferably 1 to 1.3 mm, and the length is 1 to 5 mm, preferably 1 to 1.3 mm. Moreover, the outer diameter of the rear end side joint portion 3b is 1 to 1.6 mm, preferably 1.1 to 1.5 mm, and the length is 1 to 5 mm, preferably 2 to 4 mm.

As shown in FIG. 3, the living organ dilator 1 has two X-ray contrast images fixed to the outer surface of the shaft main body at the positions corresponding to both ends of the cylindrical portion (expandable portion) 3 c when expanded. Sex members 37 and 38 are provided. In addition, it is good also as a thing provided with the two X-ray contrast enhancement members fixed to the outer surface of the shaft main-body part 2 (in this embodiment, the inner pipe | tube 4) of the position which becomes the both ends of the predetermined length of the center part of the stent 10. FIG. Furthermore, it is good also as what provides the single X-ray contrast property member fixed to the outer surface of the shaft main-body part of the position used as the center part of a stent.
The X-ray contrast members 37 and 38 are preferably ring-shaped members having a predetermined length, or those obtained by winding a linear body in a coil shape, and the forming material is, for example, gold, platinum, tungsten or Those alloys or silver-palladium alloys are suitable.

And the stent 10 is mounted | worn so that the balloon 3 may be encapsulated. The stent is manufactured by processing a metal pipe having a smaller diameter than that at the time of stent expansion and an inner diameter larger than the outer diameter of the folded balloon. Then, a balloon is inserted into the manufactured stent, and a uniform force is applied to the outer surface of the stent inward to reduce the diameter, thereby forming a product-state stent. In other words, the stent 10 is completed by compression mounting on the balloon.
A linear rigidity imparting body (not shown) may be inserted between the inner tube 4 and the outer tube 6 (in the balloon expansion lumen 9). The rigidity imparting body prevents extreme bending of the main body 2 of the living organ expanding device 100 at the bent portion and does not significantly reduce the flexibility of the living organ expanding device 100, and the distal end of the living organ expanding device 100. Easy to push the part. It is preferable that the tip of the rigidity imparting body has a smaller diameter than other parts by a method such as polishing. In addition, it is preferable that the distal end of the small diameter portion of the rigidity imparting body extends to the vicinity of the distal end portion of the main body outer tube 6. The rigidity imparting body is preferably a metal wire, and is preferably an elastic metal such as stainless steel having a wire diameter of 0.05 to 1.50 mm, preferably 0.10 to 1.00 mm, a superelastic alloy, etc. Is a high-strength stainless steel for springs and a superelastic alloy wire.

In the living organ dilator 1 of this embodiment, as shown in FIG. 1, a branch hub 7 is fixed to the proximal end. The branch hub 7 has a guide wire introduction port 71 that communicates with the guide wire lumen 8 and forms a guide wire port, and communicates with the inner tube hub fixed to the inner tube 4 and the balloon expansion lumen 9 and the injection port 72. And an outer tube hub fixed to the outer tube 6. The outer tube hub and the inner tube hub are fixed to each other. As a material for forming the branch hub 7, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be preferably used.
Note that the structure of the living organ dilator is not limited to the above, and may have a guide wire insertion port communicating with the guide wire lumen at an intermediate portion of the living organ dilator.

  As shown in FIG. 5, the stent 10 is a linear body having a number of linear components 18 extending in the axial direction of the stent 10, and the linear components 18 or other components extending in the axial direction of the stent 10. A linear component is attached to the balloon 3 so as to cross the fold 35 of the balloon 3. Further, all of the multiple linear components 18 extending in the axial direction of the stent 10 or a plurality of the linear components 18 among the multiple linear components 18 have extended portions 15 extending in the circumferential direction of the stent 10. I have. Then, the ends of all the extended portions or some of the plurality of extended portions 15 (in other words, not all of the extended portions but a large number of extended portions) enter under the fold 35 of the balloon 3. ing.

As shown in FIGS. 5 and 8 to 11, the stent 10 of this embodiment is formed by a linear body having a large number of linear components 18 extending in the axial direction of the balloon 3, and a plurality of axial stents are formed in the axial direction. The ring-shaped body 12 arranged and the connection part 13 which connects between each ring-shaped body 12 adjacent to an axial direction are provided.
In particular, in the stent 10 of this embodiment, the annular body 12 includes a plurality of one end side bent portions (peak portions) 16 located on one end side of the stent and a plurality of other end side bent portions (valleys) located on the other end side. Part) 17, a one-side bent part 16 and the other-end bent part 17 and a wavy annular body having a linear component 18 extending in the axial direction of the stent. Further, in this stent 10, the linear component 18 extending in the axial direction of the stent extends substantially parallel to the central axis of the stent when attached to the balloon 3. The annular bodies 12 adjacent in the axial direction are connected by a connecting portion 13. In particular, in the stent 10 of this embodiment, the two adjacent annular bodies are such that the other end side bent portion 17 of one annular body and the one end side bent portion 16 of the other annular body are close to each other, And it is connected by the connection part 13 in the proximity | contact part.

As shown in FIG. 8 and FIG. 9 which is a development view thereof, and FIG. 11 which is a development view thereof and FIG. It is comprised by the endless wavy body which continued cyclically | annularly. In addition, 4-10 are suitable for the number of the peaks (or valleys) of the wavy annular body. In the stent 10 of this embodiment, a plurality (specifically, three) joints 13 are provided between the adjacent annular bodies 12. In addition, although it is preferable to provide two or more joining parts 13 between adjacent annular bodies, you may provide only one. Furthermore, you may connect all the one end side bending parts and other end side bending parts which adjoin between adjacent annular bodies by the junction part 13. FIG.
In addition, the form of the stent of this invention is limited to the thing of the form arrange | positioned so that the one end side bending part and other end side bending part between adjacent annular bodies may adjoin like the stent 10 mentioned above. is not.

  As shown in FIGS. 5, 6, and 8 to 11, the stent 10 includes a linear component 18 that extends in the axial direction of the plurality of stents 10, and an extension portion 15 that extends in the circumferential direction of the stent 10. I have. As shown in FIGS. 5, 8, and 9, the extending portion 15 does not come into contact with the linear components adjacent to each other in the circumferential direction when mounted on the balloon 3 (compressed state). More preferably, the extension portion 15 is closer to the linear component adjacent in the circumferential direction than the portion other than the extension portion, but is preferably slightly separated. And it is preferable that the extension part 15 is formed in the bending part of the annular body 12, or the bending part vicinity. The stent 10 is deformed into the state of FIGS. 8 and 9 by being compressed from the state of FIG. 10 and its expanded view of FIG. 11. At the time of this deformation, the adjacent bent portions 16 and 17 in one annular body are deformed in the approaching direction. That is, since the bent portions 16 and 17 have a large amount of movement during compression, by forming the extension portion near the bent portion or the bent portion, the amount of movement of the extension portion during compression (when deformed) also increases. It becomes easy to invade under the fold of the balloon.

  In the stent 10, the extended portion 15 is formed by a part of the linear component 18 bulging in the circumferential direction of the stent 10. Specifically, the extending portion 15 is formed by expanding the width of a part of the linear component 18 in the circumferential direction of the stent 10. Further, in the stent 10, the extending portion 15 bulges only in one circumferential direction of the stent 10. In the stent 10, the extension 15 is formed at the end of the linear component 18 connected to the bent portion 17 or at the boundary between the bent portion 17 and the linear component 18. As shown in FIGS. 5, 8, and 9, the end portion of the extending portion 15 is a curved end having no edge. Moreover, in this stent 10, as shown in FIG.5, FIG8 and FIG.9, the shape of the extension part 15 is a semicircle shape. Note that the shape of the extending portion may be a semi-elliptical shape, a semi-polygonal shape without an edge, a triangular shape without an edge, or the like.

  And in this stent 10, the cyclic | annular body 12 provided with the extension part 15 and the cyclic | annular body 12 which is not provided are arrange | positioned so that it may become alternate. In addition, the annular body 12 having the extending portion 15 is provided with extending portions that extend in the circumferential direction and the same direction of a plurality, specifically, three stents. In addition, you may provide an extension part in all the annular bodies 12 like the stent 20 shown in FIG. Further, in the stent 10 of this embodiment, as shown in FIGS. 8 to 11, each annular body 12 having the extension 15 is arranged on a straight line in which the extension 15 is substantially parallel to the central axis of the stent 10. Accordingly, the stent 10 includes a plurality of extending portion rows in which the plurality of extending portions 15 are arranged substantially parallel and linearly with respect to the central axis of the stent 10. Yes. The plurality of extended portion rows correspond to the folds 35 of the balloon 3 described above.

  As shown in FIGS. 8 to 11, the stent 10 includes a plurality (specifically, three) of extended portion rows so as to correspond to the folds 35 of the balloon 3. The plurality (specifically, three) of extended portion rows are preferably formed so as to be substantially equiangular with respect to the central axis of the balloon (stent). In other words, the stent 10 of this embodiment includes three extending portion rows, which are present every about 120 degrees with respect to the central axis of the balloon (stent). Further, four or more extended part rows may be provided, and also in this case, each extended part row is formed so as to be substantially equiangular with respect to the central axis of the balloon (stent). It is preferable. In addition, as a number of the extension part row | line | columns, about 2-8 are suitable, and 2-5 are especially preferable. Moreover, the number of the extension part row | line | column should just be able to respond | correspond to each fold 35 of the balloon 3, and is not limited to the same number, The number of integral multiples of the number of folds may exist.

  In the living body organ dilator 1 of this embodiment, the stent 10 is formed of the balloon 15 by the extended portion 15 that has entered the fold 35 and the linear component 18 that crosses the fold of the balloon 3. 3 is gently held. In particular, in the living organ dilator 1 of this embodiment, as shown in FIG. 5, the fold 35 of the balloon 3 is intermittently pressed from above by the bent portion of the annular body 12 that crosses the fold 35 of the balloon 3. It is in the state. Specifically, the stent 10 has a plurality of intersecting portions that intersect with the fold 35 of the balloon 3 (cross over the fold). Adjacent intersections are not spaced equidistant from each other in the axial direction of the stent, but are alternately separated from each other by a predetermined distance. And the extension part 15 is located between the crossing parts which are spaced apart, and enters the fold 35 of the balloon 3 so that the balloon 3 is slightly lifted. Many such portions exist in the axial direction. Therefore, the stent 10 gently holds the balloon 3 without damaging the balloon.

Moreover, as a stent used for the biological organ dilating instrument of the present invention, the stent 20 shown in FIG. 12 may be used. In the stent 20, all the annular bodies 12 are provided with the extending portions 15. The basic configuration including the shape of the annular body of the stent 20 is the same as that of the stent 10 described above. The difference is that all the annular bodies 12 are provided with the extending portions 15 and the extension in each annular body. This is the number of parts 15. In this stent 20, the two adjacent annular bodies are such that the other end side bent portion 17 of one annular body and the one end side bent portion 16 of the other annular body are close to each other. An extending portion 15 is provided in the proximity portion. Specifically, extending portions 15 are provided in the vicinity of all the other end side bent portions 17 of one annular body 12, and all the one end side bent portions of the annular body 12 adjacent to the one annular body are provided. In the vicinity of the portion 16, an extending portion 15 is provided. And each extension part 15 adjacent to an axial direction is arrange | positioned so that it may be on the straight line substantially parallel with respect to the center axis | shaft of the stent 20, Thereby, the stent 20 has the some extension part 15 in it. More than the number of each fold of a balloon, the extended part row | line | column arrange | positioned substantially parallel and linearly with respect to the center axis | shaft of the stent 20 is provided. The plurality of extending portion rows are formed so as to be substantially equiangular with respect to the central axis of the balloon (stent).
By having many extending portions 15 in this way, the number of extending portions that enter under the folds of the balloon also increases, and the stent can gently and reliably hold the balloon 3 without damaging the balloon. It will be sandwiched between.

In addition, the living organ dilating instrument of the present invention may be as shown in FIGS.
FIG. 13 is an enlarged view of the distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 14 is a partially enlarged view of FIG. FIG. 15 is a developed view of the in-vivo stent of the living organ dilator shown in FIG.
The difference between the living organ dilator 100 of this embodiment and the above-described living organ dilator 1 is only in the form of a stent. The basic form of the stent 30 used in the living organ dilator 100 of this embodiment and the stent 10 described above is the same, and the major difference is that the one end side bent portion 16 and the other end side bent portion 17 are connected. And a linear component 18a extending in the axial direction of the stent.

In the stent 30 used in this embodiment, the annular body 12 includes a plurality of peak portions (one end side bent portion) 16 located on one end side of the stent and a plurality of valley portions (the other end side) located on the other end side. Side bent portion 17, and one end side bent portion 16 and the other end side bent portion 17 are connected to each other and a wavy annular body having a linear component 18 a extending in the axial direction of the stent is formed. The linear component 18a extending in the axial direction of the stent extends obliquely at a predetermined angle with respect to the central axis of the stent when attached to the balloon 3. Further, the annular bodies 12 adjacent to each other in the axial direction are connected by a connection portion 13. Also in the stent 30 of this embodiment, the two adjacent annular bodies are such that the other end side bent portion 17 of one annular body and the one end side bent portion 16 of the other annular body are close to each other, and The connection portion 13 is connected in the proximity portion.
The linear component 18 a that extends obliquely at a predetermined angle with respect to the central axis of the stent 30 includes an extending portion 15 that extends in the circumferential direction of the stent 30. As the form of the extension part 15, the form described in the stent 10 is suitable, and all the annular bodies 12 may have an extension part like the stent 20.

Further, the living body organ dilating instrument of the present invention may be as shown in FIGS.
FIG. 16 is an enlarged view of a distal end portion of a living organ dilator according to another embodiment of the present invention.
FIG. 17 is a partially enlarged view of FIG. FIG. 18 is a front view of the in-vivo stent of the living organ dilator shown in FIG. FIG. 19 is a development view of the in-vivo stent shown in FIG.
The difference between the living organ expanding device 200 of this embodiment and the living organ expanding device 1 described above is only in the form of a stent.

  Similar to the stent 10 described above, the stent 40 used in the living organ dilating instrument 200 is the same in that it has a connecting portion 46 that connects the annular bodies 42 adjacent to the plurality of annular bodies 42. In this stent 40, each annular body 42 is arranged so that a plurality of linear ring portions 44 that are long in the axial direction of the stent are surrounded by the central axis of the stent 40, and adjacent linear ring portions 44 are joined. It is connected at the part 45. The connecting portion 46 includes an extending portion 47 that extends in the axial direction of the stent and extends in the circumferential direction of the stent 40 in a state of being attached to the balloon. And the edge part of the extension part 47 of all or one part has penetrate | invaded under the fold 35 of the balloon 3 as shown in FIG.

  In the stent 40, the annular body 42 includes a plurality of linear ring portions 44 and a joint portion 45 that connects the side portions of the adjacent linear ring portions 44. Specifically, the annular body 42 has a linear ring portion 44 that is long in the axial direction of the stent 40 in the circumferential direction of the plurality of stents, and these are joined by the joint portion 45 at the side portion. The linear ring portion 44 has a substantially rhombus shape, and includes two circumferential corner portions facing the circumferential direction of the stent 40, two axial corner portions facing the axial direction of the stent 40, and four corner portions. There are four diagonal lines to be connected. And the junction part 45 has connected the circumferential direction corner | angular part of one linear ring part which adjoins and adjoins, and the circumferential direction corner | angular part of the other linear ring part. Further, the number of the linear ring portions 44 in one annular body 42 is preferably 4 to 10. In addition, as a shape of a linear ring part, the polygonal shape of five or more corners long in an axial direction, and an ellipse may be sufficient.

  As shown in FIG. 19, the stent 40 includes a plurality of annular bodies 42 arranged so as to be substantially linear in the axial direction of the stent 40, and a connecting portion 46 that connects adjacent annular bodies 42. Yes. The connecting portion 46 extends substantially parallel to the central axis of the stent 40 when the stent is attached to the balloon. Each connecting portion 46 includes an extending portion 47 extending in the circumferential direction of the stent 40. In particular, in the stent 40, the extending portion 47 is formed at the center portion of the connecting portion 46, and thus is positioned at the intermediate portion between the adjacent annular bodies 42. In the stent 40, a plurality (specifically, three) of connecting portions 46 are provided between the adjacent annular bodies 42 so as to correspond to the folds 35 of the balloon 3, Adjacent connecting portions are substantially linear. For this reason, this stent 40 is also provided with a plurality (specifically, three) of extended portion rows so as to correspond to the respective folds 35 of the balloon 3. A plurality (specifically, three) of extended portion rows (connecting portion rows) are formed so as to be substantially equiangular with respect to the central axis of the balloon (stent). That is, the stent 40 of this embodiment also includes three extended portion rows (connecting portion rows), which are present at about 120 degrees with respect to the central axis of the balloon (stent). Yes. Further, four or more extended part rows may be provided, and in this case as well, each extended part row (each connecting part row) is substantially equiangular with respect to the central axis of the balloon (stent). It is preferable to be formed as follows. In addition, as a number of the extension part row | line | column (connection part row | line | column), about 2-8 are suitable, and 2-5 are especially preferable. Further, the number of extending part rows (connecting part rows) is not limited to the same number as long as it can correspond to each fold 35 of the balloon 3, and there are a number that is an integral multiple of the number of folds. It may be a thing. In addition, although it is preferable that all the connection parts are provided with the extension part, you may provide only in part. Also in the stent 40, the extension 47 has a semi-elliptical shape. The extension portion may have a semicircular shape, a semi-polygonal shape without an edge, a triangular shape without an edge, or the like.

In addition, the living organ dilating instrument of the present invention may be as shown in FIGS.
FIG. 20 is an enlarged view of a distal end portion of a living organ dilator according to another embodiment of the present invention.
FIG. 21 is a partially enlarged view of FIG. FIG. 22 is a front view of the in-vivo stent of the living organ dilator shown in FIG. FIG. 23 is a development view of the in-vivo stent shown in FIG.
The difference between the living organ expanding device 300 of this embodiment and the living organ expanding device 1 described above is only in the form of a stent.

In the stent 60 of the living organ dilator 300, the annular body 62 is positioned on one end side of the stent, a plurality of one end side bent portions (mountains) 66, and on the other end side, like the stent 1 described above. A plurality of other-end-side bent portions (valley portions) 67 and a wave-like annular body that connects the one-end-side bent portion 66 and the other-end-side bent portion 67 and has a linear component 68 that extends in the axial direction of the stent 60. Has been.
As shown in FIGS. 22 and 23, the annular body 62 in the stent 60 has a plurality of crests and troughs with substantially the same pitch, and is an endless wavy body that is annularly continuous. In addition, 4-10 are suitable for the number of the peaks (or valleys) of the wavy annular body.

  As shown in FIGS. 21 to 23, the stent 60 has a plurality of annular bodies 62 arranged so as to be substantially linear in the axial direction of the stent 60, and a connecting portion 63 that connects adjacent annular bodies 62. It has. And the extension part 65 in this stent 60 is comprised by curving so that a part of linear component 68 extended in the axial direction of the stent 60 may protrude in the circumferential direction of a stent. Specifically, the annular body 62 is curved so that the other end portion of the linear component 68 extending in the axial direction of the stent 60 protrudes in the circumferential direction of the stent, and is integrated with the other end side bent portion 67. An extending portion 65 is provided. Then, like the extension portion of the stent 10 described above, the extension portion 65 of the stent 60 also extends in the circumferential direction when mounted on the balloon 3 (compressed state) as shown in FIGS. 21 and 22. It does not come into contact with adjacent linear components. More preferably, the extension portion 65 is closer to the linear component adjacent in the circumferential direction than the portion other than the extension portion, but is preferably slightly separated. And since the extension part 65 is integrated with the bending part as mentioned above, it deform | transforms into the state of FIG. 21 and FIG. 22 by being compressed. At the time of this deformation, the adjacent bent portions in one annular body are deformed in the approaching direction. In other words, since the bent part has a large amount of movement during compression, forming the extension part in the bent part or near the bent part also increases the amount of movement of the extension part during compression (deformation), and folding the balloon. It becomes easy to invade now.

  In this stent 60, each annular body 62 extends in the circumferential direction and the same direction of a plurality of (specifically, three) stents so as to correspond to each fold 35 of the balloon 3. A portion 65 is provided. And in the stent 60 of this Example, as shown in FIG.22 and FIG.23, each annular body 62 is arranged in multiple numbers by the axial direction so that the extension part 65 may be arrange | positioned linearly. For this reason, this stent 60 is also provided with a plurality (specifically, three) of extended portion rows so as to correspond to the respective folds 35 of the balloon 3. A plurality (specifically, three) of extended portion rows (connecting portion rows) are formed so as to be substantially equiangular with respect to the central axis of the balloon (stent). Moreover, in the stent 60 of this Example, each connection part 63 connects the adjacent annular body between the other end side bending parts in which the extension part is not formed. In addition, a connection part may connect between the one end side bending parts which do not have the extension part of an adjacent annular body. In this stent 60, only one connecting portion 63 is formed between adjacent annular bodies. A plurality of connecting portions 63 may be formed between adjacent annular bodies.

Further, in all the embodiments described above, the fold 35 of the balloon 3 is formed so as to be parallel to the central axis of the balloon (stent). It is not limited to such a thing.
For example, like the living organ dilator 400 shown in FIG. 24, the fold 35a of the balloon 3 may extend obliquely at a predetermined angle with respect to the central axis of the balloon (stent). In the case of having such a fold 35a, the arrangement form of the extension 15 provided in the stent needs to correspond to the shape of the fold. For that purpose, a stent having a large number of extending portions 15 such as the stent 20 shown in FIG. 12 is used, and a plurality of inclined extensions corresponding to the inclined form of the fold 35a of the balloon 3 is used. It is preferable to have a partial row.

  And in all the stents mentioned above, about 0.8-1.8 mm is suitable for the diameter at the time of a non-expansion, and 0.9-1.4 mm is especially more preferable. The length of the stent when not expanded is preferably about 9 to 40 mm. Further, the length of one wave-like annular body is preferably about 0.7 to 2.0 mm, and the length of one annular body is preferably about 1.5 to 4.0 mm. 0.0-3.0 mm is more preferable. Further, the number of peaks (in other words, the number of valleys) of one wavy annular body is preferably 4-8, and particularly preferably 5-7. Moreover, as a number of annular bodies, 4-15 are suitable. The diameter of the stent during molding (before compression) is preferably about 1.5 to 3.5 mm, and more preferably 2.0 to 3.0 mm. Furthermore, the thickness of the stent is preferably about 0.05 to 0.15 mm, particularly preferably 0.08 to 0.12 mm, and the width of the wavy element is about 0.07 to 0.15 mm. Is preferable, and 0.08 to 0.13 mm is particularly preferable.

As a material for forming a stent, a material having a certain degree of biocompatibility is preferable. For example, stainless steel, tantalum or a tantalum alloy, platinum or a platinum alloy, gold or a gold alloy, a cobalt base alloy, or the like can be considered. Moreover, after producing the stent shape, precious metal plating (gold, platinum) may be performed. As stainless steel, SUS316L having the most corrosion resistance is suitable.
The stent is preferably chamfered. As a method for chamfering a stent, after forming the stent into a final shape, it can be performed by chemical polishing, electrolytic polishing or mechanical polishing. The chemical polishing is preferably performed by dipping in a stainless chemical polishing solution. The stainless steel chemical polishing liquid is not particularly limited as long as it can dissolve stainless steel. For example, a mixed liquid composed of hydrochloric acid and nitric acid is used as a basic component, and an organic sulfur compound for adjusting the dissolution rate, smoothing, and imparting gloss. And those to which a surfactant is added are preferred.

  Furthermore, it is preferable to anneal after producing the final shape of the stent. By performing the annealing, the flexibility and plasticity of the entire stent are improved, and the indwellability in the bent blood vessel is improved. Compared to the case without annealing, the force that tries to restore the shape before expansion after expanding the stent, especially the force that tries to return to the linear shape when it expands at the bent blood vessel site, is reduced. The physical stimulation applied to the inner wall of the blood vessel can be reduced, and the factor of restenosis can be reduced. Annealing is performed by heating to 900 to 1200 ° C. in an inert gas atmosphere (for example, a mixed gas of nitrogen and hydrogen) and then slowly cooling so that an oxide film is not formed on the stent surface. preferable.

FIG. 1 is a front view of a living organ dilator according to an embodiment of the present invention. FIG. 2 is an enlarged view of the distal end portion of the living organ dilator shown in FIG. FIG. 3 is an enlarged cross-sectional view of the distal end portion of the living organ dilator shown in FIG. FIG. 4 is an enlarged view of the distal end portion of the living organ dilating instrument of the present invention in a state where no stent is attached. FIG. 5 is a partially enlarged view of FIG. 6 is an enlarged cross-sectional view taken along line AA in FIG. FIG. 7 is an explanatory diagram for explaining the operation of the living organ dilator according to the embodiment of the present invention. FIG. 8 is a front view of the in-vivo stent of the living organ dilator shown in FIG. FIG. 9 is a development view of the in-dwelling stent of FIG. FIG. 10 is a front view of the in-vivo indwelling stent of FIG. 8 at the time of expansion. FIG. 11 is a development view of the in-vivo indwelling stent of FIG. 8 at the time of expansion. FIG. 12 is a developed view of another example of the in-vivo stent used in the living organ dilating instrument of the present invention. FIG. 13 is an enlarged view of the distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 14 is a partially enlarged view of FIG. FIG. 15 is a developed view of the in-vivo stent of the living organ dilator shown in FIG. FIG. 16 is an enlarged view of a distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 17 is a partially enlarged view of FIG. FIG. 18 is a front view of the in-vivo stent of the living organ dilator shown in FIG. FIG. 19 is a development view of the in-vivo stent shown in FIG. FIG. 20 is an enlarged view of a distal end portion of a living organ dilator according to another embodiment of the present invention. FIG. 21 is a partially enlarged view of FIG. FIG. 22 is a front view of the in-vivo stent of the living organ dilator shown in FIG. FIG. 23 is a development view of the in-vivo stent shown in FIG. FIG. 24 is an explanatory diagram for explaining a living organ dilator according to another embodiment of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Living organ expansion instrument 2 Shaft main-body part 3 Balloon 10 Stent 15 Extension part 35 Folding point

Claims (13)

A tubular shaft main body, an expandable and folded balloon provided at the tip of the shaft main body, and a balloon that is mounted so as to enclose the folded balloon and expands by expansion of the balloon A living organ dilator comprising a stent,
The folded balloon includes a plurality of folds extending in the axial direction of the stent,
The stent is a linear body having a number of linear components extending in the axial direction of the stent, and is attached to the balloon so as to cross the fold of the balloon. All or a plurality of linear components of the plurality of linear components extending in the axial direction include extensions extending in the circumferential direction of the stent, and all or some of the ends of the plurality of extensions are A biological organ dilating instrument that has entered the fold line of the balloon. 2. The living organ according to claim 1, wherein the stent gently holds the balloon by the extending portion that has entered the fold line of the balloon and a linear component that crosses the fold line of the balloon. 3. Expansion device. Each fold of the balloon is substantially parallel to the central axis of the stent, and the stent is provided with a plurality of extending portions provided substantially parallel to the central axis of the stent. The living organ dilator according to claim 1 or 2, wherein a plurality of rows are provided so as to correspond to the respective folds of the balloon. The living organ dilator according to any one of claims 1 to 3, wherein the end portion of the extending portion is a curved end having no edge. The living organ dilator according to any one of claims 1 to 4, wherein the extension portion is configured by a part of the linear component bulging in a circumferential direction of the stent. The living organ dilator according to any one of claims 1 to 4, wherein the extending portion is configured such that a part of the linear component is curved so as to protrude in a circumferential direction of the stent. A number of linear components extending in the axial direction of the stent are linear components parallel to the central axis of the stent, and the extending portion is provided in the linear component parallel to the central axis of the stent. The living organ dilator according to any one of claims 1 to 6. A number of linear components extending in the axial direction of the stent are linear components extending obliquely at a predetermined angle with respect to the central axis of the stent, and the extending portion is predetermined with respect to the central axis of the stent. The living organ dilator according to any one of claims 1 to 6, which is provided on a linear component extending obliquely at an angle. The stent is formed of a linear body having a large number of linear components extending in the axial direction of the balloon, and connects the annular bodies arranged in a plurality in the axial direction and the annular bodies adjacent in the axial direction. The living organ dilator according to any one of claims 1 to 8, comprising a connecting portion. The living organ dilator according to claim 9, wherein the extending portion is provided on the annular body. The living organ dilator according to claim 9 or 10, wherein the extending portion is provided in the connecting portion. Each annular body connects one end-side bent portion of the plurality of stents, the other end-side bent portion of the plurality of stents, the one end-side bent portion, and the other end-side bent portion, and in the axial direction of the stent. The living organ dilator according to any one of claims 9 to 11, which is a wavy annular body having a linear component extending. Each of the annular bodies is composed of an annular body in which linear ring portions that are long in the axial direction of the stent are arranged so as to surround the central axis of the plurality of stents, and adjacent linear ring portions are connected by a joint portion. The living organ dilator according to any one of claims 9 to 11.

Images