JP2011072441A - Biological organ dilator implement - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a biological organ dilator implement for inhibiting a movement and a release of a stent mounted on a balloon enough, and having less damage of the balloon during mounting the stent. <P>SOLUTION: A biological organ dilator implement 1 has a balloon catheter 2 and a stent 10 mounted on a balloon 3. A plurality of stents are arranged to the axial direction, and adjacent annular bodies 11 are connected with joint sections 12, 13. The joint section 12 connects between the annular body 11a being odd-numbered from the tip end of the stent 10 and the even-numbered annular body 11b, and it has a first morphological sloping recessed section 22 inside having an inner surface sloping to the rear end of the stent. The joint section 13 connecting between the even-numbered annular body 11b and the odd-numbered annular body 11a has a second morphological sloping recessed section 23 inside having an inner surface sloping opposite to the first morphological sloping recessed section 22. One part of the balloon 3 intrudes in the first and second morphological sloping recessed sections. <P>COPYRIGHT: (C)2011,JPO&INPIT

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 a stent is inserted into the body from outside the body, the diameter of the stent is small at the time of insertion. The stent is expanded at a 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 does not have an expansion function in the stent itself. After the stent mounted on the balloon is inserted into the target site, the balloon is expanded, and the stent is expanded (plastic deformation) by the expansion force of the balloon. Fix it in close contact with the inner surface. 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 stent struts in a state where the balloon is folded. Yes.
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 contracted stent 10 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 clamped by the struts of the stent, and the balloon may be damaged when the struts are clamped.
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 damage the balloon when the stent is mounted.

What achieves the above object is as follows.
(1) a balloon catheter having a tubular main body, an expandable and folded balloon provided at the distal end of the main body, and being mounted by being compressed on the folded balloon; and A living organ expansion device comprising a stent that expands by expansion of the balloon,
The stent is a substantially tubular body in which a plurality of annular bodies formed of linear components are arranged so as to be adjacent to each other in the axial direction of the stent, and the adjacent annular bodies are connected by a connecting portion. The connecting portion that connects between the odd-numbered annular bodies and the even-numbered annular bodies from the distal end side of the stent extends in the circumferential direction of the stent and is inclined to the distal end side or the proximal end side of the stent. The connecting portion connecting the even-numbered annular body and the odd-numbered annular body from the distal end side of the stent extends in the circumferential direction of the stent, and A second configuration inclined recess having an inclined inner surface inclined in the opposite direction to the first configuration inclined recess is provided on the inner surface, and further, a part of the balloon is in the first configuration inclined recess and the second configuration inclined recess. Input to have the stent delivery system.

(2) The first configuration inclined recess has a cross-sectional shape inclined toward the distal end side or the proximal end side of the stent, and the second configuration inclined recess is inclined in a direction opposite to the first configuration inclined recess. The living organ dilator according to (1), which has a cross-sectional shape.
(3) Each of the annular bodies includes a plurality of distal-end bending portions of the stent and a plurality of proximal-end bending portions of the stent, and the connection portion is located between the adjacent bending portions of the adjacent annular bodies. And one end of the inclined recess is located in the bent portion of the annular body adjacent to the connection portion and the other end of the annular recess is adjacent to the connection portion. The living organ dilator according to (1) or (2), which is located at the bent portion of the body.
(4) The living body according to any one of (1) to (3), wherein the inclined recess having the first form has a substantially parallelogram-shaped cross section inclined toward the distal end side or the proximal end side of the stent. Organ dilator.
(5) The living body according to any one of (1) to (4), wherein the second configuration inclined recess has a substantially parallelogram-shaped cross section inclined in the opposite direction to the first configuration inclined recess. Organ dilator.
(6) The both ends of the first configuration inclined recess and the second configuration inclined recess are substantially orthogonal to the central axis of the stent, as described in any one of (1) to (5) above. Biological organ dilator.
(7) The living body organ expansion according to any one of (1) to (6), wherein the first configuration inclined recess and the second configuration inclined recess are wider at both end portions than at the center portion. Instruments.
(8) Said (1) thru | or (1) thru | or which has a some connection part between the said adjacent annular bodies, and is provided with the said 1st form inclination recessed part or the said 2nd form inclination recessed part in all the said connection parts. 7) The living organ dilator according to any one of the above.
(9) Said 1st form inclination recessed part and said 2nd form inclination recessed part have an acute-angled edge part, and the acute-angled edge part is a roundish edge part. (8) The living organ dilator according to any one of (8).
(10) The balloon is in a state where the stent is not expanded and the balloon is slightly expanded, and a part of the balloon enters the inclined recess of the stent due to the expansion of the balloon. (1) The living organ dilator according to any one of (9).
(11) 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 stent. The living organ dilating instrument according to any one of the above (1) to (10), which is a wavy linear body having a linear component extending in the axial direction.

In the living organ expanding device of the present invention, a stent that is mounted so as to enclose a folded balloon and expands by expansion of the balloon has an annular body formed of linear components adjacent to each other in the axial direction of the stent. A plurality of adjacent annular bodies connected to each other by a connecting portion, and a connecting portion connecting between the odd-numbered annular body and the even-numbered annular body from the distal end side of the stent is a stent. Of the first form inclined recesses extending in the circumferential direction of the stent and having an inclined inner surface inclined toward the distal end side or the proximal end side of the stent, and between the even-numbered and odd-numbered annular bodies from the distal end side of the stent. The connecting portion for connecting the first shape inclined recesses extending in the circumferential direction of the stent and having an inclined inner surface inclined in the opposite direction to the first shape inclined recesses is further provided on the inner surface. Invading the form inclined recess and the second embodiment inclined recess.
In the stent of this biological organ dilator, the first configuration inclined recesses and the second configuration inclined recesses having inclined inner surfaces with different inclination directions are alternately positioned in the axial direction of the stent, and a part of the balloon has entered each recess. Since it is in a state, movement and detachment of the stent mounted on the balloon are suppressed. In addition, since the first configuration inclined recess and the second configuration inclined recess do not firmly hold the balloon, the first configuration inclined recess and the second configuration inclined recess are less likely to damage the balloon.

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 explanatory diagram for explaining a distal end portion of a balloon cartel used in the living organ dilator shown in FIG. FIG. 4 is an enlarged cross-sectional view of a proximal end portion of the living organ dilator shown in FIG. FIG. 5 is an explanatory diagram for explaining a cross-sectional structure of a portion X in FIG. FIG. 6 is an explanatory diagram for explaining a cross-sectional structure of a Y portion in FIG. 2. FIG. 7 is a front view of the stent in a state of being mounted on the living organ dilator according to the present invention. 8 is an internal view of the deployed state of the stent of FIG. FIG. 9 is a partially enlarged view of FIG. FIG. 10 is an enlarged cross-sectional view taken along line AA in FIG. 11 is an enlarged sectional view taken along line BB in FIG. FIG. 12 is an explanatory diagram for explaining a cross-sectional shape of a stent used in the living organ dilating instrument of the present invention. 13 is an internal view of the stent of FIG. 7 in an expanded state and a deployed state. FIG. 14 is an expanded inner view of another example of the stent used in the living organ dilating instrument of the present invention. FIG. 15 is an expanded inner view of another example of the stent used in the living organ dilator according to the present invention. FIG. 16 is an explanatory view for explaining the form of an inclined concave portion of another example of the stent used in the living organ dilating instrument of the present invention. FIG. 17 is an explanatory view for explaining the form of the inclined concave portion of another example of the stent used in the living organ dilating instrument of the present invention.

The living organ dilator according to the present invention will be described using the following preferred embodiments.
A living organ dilator 1 of the present invention includes a balloon catheter 2 including a tubular main body 6 and an expandable and folded balloon 3 provided at the distal end of the main body 6, and the folded balloon 3. And a stent 10 that is mounted by being compressed and expanded by expansion of the balloon 3. The stent 10 is a substantially tubular body in which a plurality of annular bodies 11 formed of linear components are arranged so as to be adjacent to each other in the axial direction of the stent, and the adjacent annular bodies 11 are connected by connecting portions 12 and 13. . The connecting portion 12 connecting the odd-numbered annular bodies 11a and the even-numbered annular bodies 11b from the distal end side of the stent 10 extends in the circumferential direction of the stent 10 and is inclined toward the distal end side or the proximal end side of the stent 10. A first configuration inclined recess 22 having an inclined inner surface is provided on the inner surface. The connecting portion 13 that connects the even-numbered annular bodies 11b and the odd-numbered annular bodies 11a from the distal end side of the stent 10 extends in the circumferential direction of the stent 10 and is inclined in the direction opposite to the first configuration inclined recess 22. A second form inclined recess 23 having an inclined inner surface is provided on the inner surface. A part of the balloon 3 enters the first configuration inclined recess 22 and the second configuration inclined recess 23.

As shown in FIGS. 1 to 3, the living organ dilator 1 of this embodiment includes a stent 10 and a balloon catheter 2 to which the stent 10 is attached.
The balloon catheter 2 includes a tube-shaped main body 6 and a foldable and expandable balloon 3 provided at the distal end of the main body 6, and the stent 10 encloses the balloon 3 in a folded state. And is expanded by expansion of the balloon 3.
The stent 10 is a so-called balloon-expandable stent that has a diameter for insertion into a lumen in a living body and is expandable when a force spreading in the radial direction from the inside of the tubular body is applied.
In the living organ dilator 1 of this embodiment, as shown in FIG. 3, the main body portion 6 has one end opened at the front end of the main body portion 6 and the other end opened at the rear end portion of the main body portion 6. A wire lumen 15a is provided.
The balloon catheter 2 includes a main body portion 6 and a stent expansion balloon 3 fixed to the distal end portion of the main body portion 6, and a stent 10 is mounted on the balloon 3. The main body 6 includes an inner tube 15, an outer tube 16, and a branch hub 5.

As shown in FIGS. 3 and 4, the inner tube 15 is a tube body including a guide wire lumen 15 a for inserting a guide wire therein. The inner tube 15 has a length of 100 to 2500 mm, more preferably 250 to 2000 mm, an outer diameter of 0.1 to 1.0 mm, more preferably 0.3 to 0.7 mm, and a wall thickness of 10 mm. ˜250 μm, more preferably 20-100 μm. The inner tube 15 is inserted into the outer tube 16, and a tip portion of the inner tube 15 protrudes from the outer tube 16. A balloon expansion lumen 18 is formed by the outer surface of the inner tube 15 and the inner surface of the outer tube 16, and has a sufficient volume. The outer tube 16 is a tube body that is inserted in the inner tube 15 and located at a portion where the tip is slightly retracted from the tip of the inner tube 15.
The outer tube 16 has a length of 100 to 2500 mm, more preferably 250 to 2000 mm, an outer diameter of 0.5 to 1.5 mm, more preferably 0.7 to 1.1 mm, and a wall thickness of 25. It is -200 micrometers, More preferably, it is a thing of 50-100 micrometers.
In the living organ dilator 1 of this embodiment, the outer tube 16 is formed by the distal end side outer tube 16a and the main body side outer tube 16b, and both are joined. The distal end side outer tube 16a has a tapered diameter at a portion closer to the distal end than the joint portion with the main body side outer tube 16b, 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 16a is 0.50 to 1.5 mm, preferably 0.60 to 1.1 mm. Moreover, the outer diameter of the base end part of the front end side outer tube | pipe 16a and the main body side outer tube | pipe 16b is 0.75-1.5 mm, Preferably it is 0.9-1.1 mm.
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 15, and the rear end side joint portion 3b. Is fixed to the tip of the outer tube 16. The balloon 3 communicates with the balloon expansion lumen 18 in the vicinity of the proximal end portion.
As a material for forming the inner tube 15 and the outer tube 16, a material having a certain degree of flexibility is preferable. 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 is foldable, and can be folded around the outer periphery of the inner tube 15 when not expanded. As shown in FIG. 3, the balloon 3 has an expandable portion that is a cylindrical portion (preferably, a substantially cylindrical portion) having substantially the same diameter so that the attached stent 10 can be expanded. 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 15 with the front end side joint portion 3a and the rear end side joint portion 3b to the front end of the outer tube 16 with 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.
The balloon 3 forms an expansion space 3 c between the inner surface of the balloon 3 and the outer surface of the inner tube 15. The expansion space 3c communicates with the expansion lumen 18 at 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 reliably injected into the balloon from the expansion lumen 18.

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 part 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 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 members fixed to the outer surface of the main body at positions corresponding to both ends of the cylindrical portion (expandable portion) when expanded. 14a and 14b. It should be noted that two X-ray contrast contrast members fixed to the outer surface of the main body portion 6 (in this embodiment, the inner tube 15) at positions corresponding to both ends of a predetermined length of the central portion of the stent 10 may be provided. Furthermore, it is good also as what provides the single X-ray contrast property member fixed to the outer surface of the main-body part of the position used as the center part of a stent.
The X-ray contrast members 14a and 14b 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 15 and the outer tube 16 (within the balloon expansion lumen 18). The rigidity imparting body prevents extreme bending of the main body portion 6 of the living organ expanding device 1 at the bent portion and does not significantly reduce the flexibility of the living organ expanding device 1, and the distal end of the living organ expanding device 1 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 end of the small diameter portion of the rigidity imparting body extends to the vicinity of the end of the outer tube 16. 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 FIGS. 1 and 4, the branch hub 5 is fixed to the proximal end. The branch hub 5 has a guide wire introduction port 19 that communicates with the guide wire lumen 15 a to form a guide wire port, and has an inner tube hub 8 fixed to the inner tube 15 and an outer tube hub fixed to the outer tube 16. It consists of seven. The outer tube hub 7 has an injection port 17 communicating with a balloon expansion lumen 18. The outer tube hub 7 and the inner tube hub 8 are fixed. As a material for forming the branched hub 5, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be preferably used. A reinforcing tube 9 is provided at the proximal end of the outer tube 16. The outer tube hub 7 and the inner tube hub 8 are fixed by inserting and joining the inner tube 15 from the rear end of the outer tube hub 7 attached to the proximal end portion of the outer tube 16. At this time, by applying an adhesive to the joint between the inner tube hub 8 and the outer tube hub 7, both can be securely fixed. In addition, the structure of the proximal end of the living organ dilator 1 is not limited to the above, and the branch hub 5 is not provided, and the guide wire lumen 15a and the balloon expanding lumen 18 are respectively provided at the rear end, for example. A tube having a port member that forms an opening may be liquid-tightly attached.
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.

  The stent 10 is mounted on the folded balloon 3 by being compressed. In addition, the stent 10 has a substantially tubular shape in which a plurality of annular bodies 11 formed of linear components are arranged so as to be adjacent to each other in the axial direction of the stent, and the adjacent annular bodies 11 are connected by connecting portions 12 and 13. Is the body. The connecting portion 12 connecting the odd-numbered annular bodies 11a and the even-numbered annular bodies 11b from the distal end side of the stent 10 extends in the circumferential direction of the stent 10 and is inclined toward the distal end side or the proximal end side of the stent 10. The 1st form inclination recessed part 22 which has a cross-sectional shape is provided in an inner surface. The connecting portion 13 that connects the even-numbered annular bodies 11b and the odd-numbered annular bodies 11a from the distal end side of the stent 10 extends in the circumferential direction of the stent 10 and is inclined in the direction opposite to the first configuration inclined recess 22. A second form inclined recess 23 having a cross-sectional shape is provided on the inner surface.

In the stent 10 of this embodiment, each annular body 11 (11a, 11b) includes one end-side bent portions 35, 37 of a plurality of stents, the other end-side bent portions 36, 38 of the plurality of stents, and one end-side bent portions 35. , 37 and the other end-side bent portions 36, 38, and linear component elements 31, 32, 33, 34 extending in the axial direction of the stent.
Specifically, as shown in FIGS. 7 to 9, the wavy annular bodies 11 a and 11 b each include a plurality of one end side bent portions 35 and 37 having apexes on one end side in the axial direction of the stent 10 and the axis of the stent 10. It has a plurality of other end side bent portions 36 and 38 having apexes on the other end side in the direction, and is constituted by an endless wavy body that is annularly continuous. The one end side bent portions 35 and 37 and the other end side bent portions 36 and 38 in the annular bodies 11a and 11b are alternately formed, and the numbers thereof are the same.
The total number of the one-end-side bent portions 35 and the one-end-side bent portions 37 in one wavy annular body 11a, 11b is 8 in the one shown in FIGS. Similarly, the total number of the other-end-side bent portions 36 and the other-end-side bent portions 38 in one wavy annular body 11a, 11b is eight. The numbers of the one end side bent portions and the other end side bent portions in the wavy annular bodies 11a and 11b are preferably 4 to 12, and more preferably 6 to 10. Further, the length of the annular body 11 in the axial direction is preferably 0.5 to 2.0 mm, particularly preferably 0.9 to 1.5 mm.

Each annular body 11 (11a, 11b) includes a plurality of stent distal-end bending portions 35 (35a) and a plurality of stent proximal-end bending portions 38 (38a), and the connection portions 12, 13 are adjacent to each other. The adjacent bent portion 35a and the bent portion 38a of the annular body are connected.
Specifically, the odd-numbered annular body 11a and the even-numbered annular body 11b from the distal end side of the stent 10 are connected by the connecting portion 12, and the even-numbered annular body 11b and the odd-numbered annular body 11b from the distal end side of the stent 10 are connected. The second annular body 11 a is connected by the connecting portion 13. And the connection part 12 equips an inner surface with the 1st form inclination recessed part 22 which has the cross-sectional shape extended in the circumferential direction of the stent 10 and inclined in the front end side or the base end side of the stent 10. FIG. The connecting portion 13 includes, on the inner surface, a second configuration inclined recess 23 that extends in the circumferential direction of the stent 10 and has a cross-sectional shape that is inclined in the opposite direction to the first configuration inclined recess 22. For this reason, the connection part 12 and the connection part 13 which are adjacent to an axial direction differ in the inclination direction of the inclination recessed part with which each is provided. Further, the first configuration inclined recess 22 and the second configuration inclined recess 23 are formed so as to scrape at least the inner surfaces of the connecting portions 12 and 13 over the entire width thereof, and as shown in FIGS. Both side surfaces of 22 and 23 are exposed.

In the stent 10 of this embodiment, the first form inclined recess 22 has one end positioned at the bent portion 35a of one annular body adjacent to the connection portion 12 and the other end adjacent to the other adjacent to the connection portion 12. It is located at the bent portion 38a of the annular body. Similarly, the second form inclined recess 23 is positioned at one of the bent portions 35a of the annular body adjacent to the connecting portion and the other end of the second annular portion 23a to the bent portion 38a of the other annular body adjacent to the connecting portion 13. It is supposed to be located. That is, in the stent 10 of this embodiment, one end and the other end of the first configuration inclined recess 22 and the second configuration inclined recess 23 are located at the bent portion of the annular body to which the connection portions 12 and 13 are connected. Yes. Further, in the stent 10 of this embodiment, the first configuration inclined recess 22 and the second configuration inclined recess 23 have a wider (longer) width at both ends (the circumferential length of the stent 10) than the central portion. Yes.
And the 1st form inclination recessed part 22 has a substantially parallelogram-shaped cross-sectional shape inclined to the front end side or the base end side (specifically, base end side as shown in FIG. 10) of the stent 10. ing. Similarly, the second configuration inclined recess 23 has a substantially parallelogram-shaped cross section inclined in the opposite direction to the first configuration inclined recess 22 (specifically, the tip side as shown in FIG. 11). ing. Further, as shown in FIG. 10, the first form inclined recess 22 has an end portion (inner edge) 22a whose base end side section has an acute angle, and the acute end portion 22a is a rounded end portion. ing. Similarly, as shown in FIG. 11, the second configuration inclined recess 23 has an end (inner edge) 23 a having a sharp end section, and the acute end 23 a is a rounded end. ing. Further, as shown in FIGS. 7 to 9, it is preferable that both ends of the first configuration inclined recess 22 and the second configuration inclined recess 23 are substantially orthogonal to the central axis of the stent 10.

And in the stent 10 of this Example, it has several connection parts 12 and 13 between the adjacent annular bodies 11a and 11b, and 1st form inclination recessed part 22 or 2nd form in all of the several connection parts 12 and 13 is provided. An inclined recess 23 is provided. In addition, when it has the some connection parts 12 and 13 between the annular bodies 11a and 11b, the 1st form inclination recessed part 22 or the 2nd form inclination recessed part 23 may be provided in at least one of the some connection parts 12 and 13. Good.
Moreover, in the biological organ dilating instrument 1 of the present invention, as shown in FIGS. 5 and 6, a part of the balloon 3 enters the first form inclined recess 22 and the second form inclined recess 23. As shown in FIG. 5, when a part 3 d of the balloon 3 has entered the first configuration inclined recess 22 and stress is applied in the distal direction of the stent 10 (upward in FIG. 5), the proximal direction Since the inclined surface portion that is inclined to engage with the invading balloon, the movement of the stent relative to the balloon 3 is suppressed. Further, as shown in FIG. 6, when a part 3 e of the balloon 3 has entered the second configuration inclined recess 23 and stress is applied in the proximal direction of the stent 10 (downward in FIG. 6), Since the inclined surface portion inclined in the distal direction is engaged with the invading balloon, the movement of the stent relative to the balloon 3 is suppressed.
Moreover, the 1st form inclination recessed part 22 and the 2nd form inclination recessed part 23 need to be the magnitude | size and shape which a balloon can penetrate | invade. By mounting the stent 10 by being compressed onto the folded balloon 3, a part of the balloon enters the first configuration inclined recess 22 and the second configuration inclined recess 23. The balloon 3 does not expand the stent 10 and the balloon 3 is expanded slightly so that a part of the balloon 3 enters the inclined recesses 22 and 23 of the stent 10 more reliably. You may let them.
And as a magnitude | size of a 1st form inclination recessed part and a 2nd form inclination recessed part, the following are preferable. This will be described using the first form inclined concave model shown in FIG.
The balloon thickness is A, the depth of the concave portion of the stent is t, the thickness of the stent in the concave portion is Z, the inclination angle of the acute angle portion of the concave portion is θ, and the width of the concave portion shown in FIG.
In this case, the width b of the recess is preferably 2 to 30 times the thickness of the balloon. The depth t is preferably 1 to 4 times the thickness of the balloon. Moreover, it is preferable that the thickness Z is more than the depth of a recessed part. Further, the inclination angle θ is less than 90 degrees and is preferably 60 degrees or less.
Moreover, the shape of the 1st form inclination recessed part and the 2nd form inclination recessed part is not limited to a thing whose cross-section mentioned above is a parallelogram shape. For example, as shown in FIGS. 16 and 17, the first configuration inclined recess 52 has an inclined surface 52a inclined at an acute angle on the distal end side or the proximal end side (specifically, the proximal end side) of the stent 10a. The surface facing the inclined surface 52a has a quadrangular cross section that is not an inclined surface (orthogonal surface). Similarly, the second configuration inclined recess 53 has an inclined surface 53a inclined at an acute angle in a direction opposite to the first configuration inclined recess 52 (specifically, the tip side), and the surface facing the inclined surface 53a is: It has a quadrangular cross section that is not an inclined surface (orthogonal surface). And as shown in FIG. 16, the 1st form inclination recessed part 52 has the acute angle edge part (inner edge) 52b of the inclined surface 52a inclined at an acute angle, and this acute angle edge part 52b was roundish. It is an end. Similarly, as shown in FIG. 17, the second configuration inclined recess 53 has an acute-angle end portion (inner edge) 53b of an inclined surface 53a inclined at an acute angle, and the acute-angle end portion 53b is rounded. It is an end.

  In the stent 10 of this embodiment, the annular body 11 (11a, 11b) is connected to one end of the parallel linear portion 31 via a bent portion 35 (35a), as shown in FIGS. And, at least when the stent 10 is expanded, the first inclined linear portion 32 is inclined at a predetermined angle with respect to the central axis of the stent 10, and one end of the first inclined linear portion 32 is connected to the bent portion 36. In addition, an inclined linear portion (in this embodiment, an inclined curved portion) 33 extending obliquely at a predetermined angle with respect to the central axis of the stent, and one end of the inclined curved portion 33 and a bent portion 37 are connected. And a plurality of deformed M-shaped linear portions composed of four linear portions of the second inclined linear portion 34 that is inclined at a predetermined angle with respect to the central axis of the stent 10 when the stent 10 is expanded. It has become. Then, the adjacent deformed M-shaped linear portions are connected by a bent portion 38 (38a) connecting one end of the second inclined linear portion 34 and the other end of the parallel linear portion 31, thereby making an endless wavy line. A ring-shaped body 11 is formed. For this reason, shortening of the axial length of the wavy annular body 11 during expansion of the stent is suppressed, and sufficient expansion holding force is applied to the wavy annular body 11.

  In particular, in the stent 10 in this embodiment, as shown in FIG. 8 (before stent expansion and when the stent is compressed) and FIG. 10 (when the stent is expanded), the wavy annular body 11 is connected to one end of the parallel linear portion 31. A first inclined linear portion 32 that is connected via the bent portion 35 (35a), is substantially parallel to the central axis of the stent 10 (before stent expansion), and is inclined at a predetermined angle when the stent is expanded; An inclined curved portion 33 connected to one end of the first inclined linear portion 32 via the bent portion 36 and extending obliquely at a predetermined angle with respect to the central axis of the stent, and one end of the inclined curved portion 33 The four inclined linear portions 34 are connected via the bent portion 37 and are substantially parallel to the central axis of the stent 10 (before the stent is expanded) and are inclined at a predetermined angle when the stent 10 is expanded. From the linear part Modified M-shaped linear portion is assumed that a plurality continuous. That is, the first inclined linear portion 32 and the second inclined linear portion 34 are substantially parallel to the central axis of the stent 10 before expansion of the stent, in other words, when the stent is compressed. . For this reason, the outer diameter at the time of compression of a stent can be made into a small diameter.

Further, in the stent 10 of this embodiment, the apexes of the one end side bent portions 35 and 37 and the apexes of the other end side bent portions 36 and 38 are arranged substantially linearly with respect to the axial direction of the stent. .
Adjacent wavy-line annular bodies 11 are connected by connecting portions 12 and 13. In particular, in the stent 10 of this embodiment, the ends of the parallel straight portions 31 of the adjacent wavy annular bodies 11 are connected by the short and short connecting portions 12 and 13. For this reason, the distance between the adjacent wavy-line annular bodies 11 becomes short, and the formation of the low expansion force portion caused between the adjacent wavy-line annular bodies 11 becomes extremely small.
Further, in the stent 10 of this embodiment, the two parallel linear portions 31 connected by the connecting portions 12 and 13 are substantially linear. For this reason, the shortening of the stent between the adjacent wavy-line annular bodies 11 when the stent 10 is expanded can be prevented. The stent 10 includes a plurality of connecting portions 12 and 13 that connect adjacent wavy annular bodies 11. For this reason, adjacent wavy-line annular bodies are not unnecessarily separated, and the entire stent exhibits a sufficient expansion force.

Moreover, as a stent used for the biological organ expansion instrument of this invention, what is shown in FIG. 14 may be used.
In the stent 20 of this embodiment, as shown in FIG. 14, each of the annular bodies 11a and 11b includes a plurality of one end side bent portions (mountains) 46 located on one end side of the stent and a plurality of pieces located on the other end side. The other end side bent portion (valley portion) 47, the one end side bent portion 46, and the other end side bent portion 47 are connected, and a wavy annular body having a linear component 45 extending in the axial direction of the stent is formed. The annular bodies 11a and 11b adjacent in the axial direction from the distal end side of the stent are connected by connecting portions 12 and 13, respectively. In particular, in the stent 20 of this embodiment, the two adjacent annular bodies are such that the other end side bent portion 47 of one annular body and the one end side bent portion 46 of the other annular body are close to each other, And it is connected by the connection parts 12 and 13 in the proximity | contact part.
Specifically, the odd-numbered annular body 11 a and the even-numbered annular body 11 b from the distal end side of the stent 20 are connected by the connecting portion 12, and the even-numbered annular body 11 b and the odd-numbered annular body 11 b from the distal end side of the stent 20. The second annular body 11 a is connected by the connecting portion 13. And the connection part 12 equips an inner surface with the 1st form inclination recessed part 22 which has the cross-sectional shape extended in the circumferential direction of the stent 20 and inclined in the front end side or the base end side of the stent 20. The connecting portion 13 includes, on the inner surface, a second configuration inclined recess 23 that extends in the circumferential direction of the stent 20 and has a cross-sectional shape that is inclined in a direction opposite to the first configuration inclined recess 22. For this reason, the inclination recessed part with which each of the connection part 12 and the connection part 13 which adjoin an axial direction is provided has a different inclination direction. Moreover, the 1st form inclination recessed part 22 and the 2nd form inclination recessed part 23 are formed so that at least the inner surface of the connection parts 12 and 13 may be scraped off over the full width. Moreover, the 1st form inclination recessed part 22 and the 2nd form inclination recessed part 23 are formed so that the inner surface of the full length (the axial direction full length of a stent) of the connection parts 12 and 13 may be scraped off over the full width.

As shown in FIG. 14, the corrugated annular bodies 11a and 11b in the stent 20 of this embodiment have a plurality of crests and troughs with substantially the same pitch, and are constituted by endless corrugated bodies that are annularly continuous. . In addition, 4-10 are suitable for the number of the peaks (or valleys) of the wavy annular body. In the stent 20 of this embodiment, a plurality of (specifically, three) connection portions 12 and connection portions 13 are provided between the adjacent annular bodies 11a and 11b. And the 1st form inclination recessed part 22 or the 2nd form inclination recessed part 23 is provided in the inner surface of all the connection parts 12 and the connection parts 13. As shown in FIG. In addition, although it is preferable to provide two or more connection parts 12 and 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 connection parts 12 and 13. FIG. Further, when the plurality of connection portions 12 and 13 are provided between the annular bodies 11a and 11b, at least one of the plurality of connection portions 12 and 13 may be provided with the first configuration inclined recess 22 or the second configuration inclined recess 23. Good.
Further, in all the above-described stents, the first configuration inclined recess 22 or the second configuration inclined recess 23 is formed in the connection portions 12 and 13 located at both ends of the stent 30 as in the stent 30 shown in FIG. The first configuration inclined recess 22 and the second configuration inclined recess 23 may not be provided in the connecting portions 12 and 13 in the axial center portion of the stent 30. In addition, as the connection parts 12 and 13 located in the both ends of the stent 30 in which the 1st form inclination recessed part 22 or the 2nd form inclination recessed part 23 is provided, one each may be sufficient, but at least 2 each is provided. It is preferable.

And in all the stents mentioned above, about 0.8-1.8 mm is suitable for the diameter at the time of non-expansion of a stent, and 0.9-1.6 mm is especially more preferable. The length of the stent when not expanded is preferably about 8 to 40 mm. The length of one wavy annular body 11 is preferably about 1.0 to 2.5 mm.
Then, the stent is formed by removing the portion other than the portion that becomes the frame structure from the tubular body (specifically, the metal pipe). Specifically, unnecessary portions of metal pipes are removed by, for example, photofabrication masking and chemical etching methods, electrical discharge machining using molds, and cutting (for example, mechanical polishing and laser cutting). By doing so, a stent is formed. Moreover, it is preferable to polish the edge of the structure using chemical polishing or electrolytic polishing after the frame structure is manufactured.

  In addition, the stent of the present invention may be coated with a biocompatible material on the inner surface or outer surface, and further on both surfaces. The biocompatible material may be a synthetic resin or metal having biocompatibility. Methods for coating the stent surface with an inert metal include gold plating using electroplating, stainless steel plating using vapor deposition, silicon carbide using sputtering, diamond-like carbon, titanium nitride plating, and gold plating. Conceivable. The synthetic resin can be selected from thermoplastic or thermosetting resins. For example, polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, etc.), polyvinyl chloride, ethylene-vinyl acetate copolymer. Polymers, polyamide elastomers, polyurethanes, polyesters, fluororesins, silicone resins, etc. can be used, preferably polyolefins, polyamide elastomers, polyesters or polyurethanes, silicone resins, and biodegradable resins (eg, polylactic acid, polyglycolic acid) , A copolymer of both). The synthetic resin coating is preferably flexible to the extent that it does not hinder the bending of the frame constituting the stent. The thickness of the synthetic resin coating is 3 to 300 μm, preferably 5 to 100 μm.

  As a method of thinly coating a synthetic resin on the surface of a stent, for example, a method of inserting a stent in a synthetic resin in a molten state or a solution state, and a chemical vapor deposition in which a monomer is coated while being polymerized on the surface of the stent. and so on. When an extremely thin resin coating is required, coating using a dilute solution or chemical vapor deposition is preferable. Furthermore, in order to improve the biocompatible material, an antithrombotic material may be coated or fixed on the resin coating. Various known resins can be used alone or in combination as the antithrombotic material. For example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA) Block copolymers) can be used preferably.

DESCRIPTION OF SYMBOLS 1 Living organ expansion instrument 2 Balloon catheter 3 Balloon 6 Main body part 10 Stent 11 (11a, 11b) Annulus 12, 13 Connection part 22 1st form inclination recessed part 23 2nd form inclination recessed part

Claims (11)

A balloon catheter having a tubular main body, an expandable and folded balloon provided at the distal end of the main body, and being mounted by being compressed on the folded balloon; and A living organ dilator comprising a stent that expands by expansion,
The stent is a substantially tubular body in which a plurality of annular bodies formed of linear components are arranged so as to be adjacent to each other in the axial direction of the stent, and the adjacent annular bodies are connected by a connecting portion. The connecting portion that connects between the odd-numbered annular bodies and the even-numbered annular bodies from the distal end side of the stent extends in the circumferential direction of the stent and is inclined to the distal end side or the proximal end side of the stent. The connecting portion connecting the even-numbered annular body and the odd-numbered annular body from the distal end side of the stent extends in the circumferential direction of the stent, and A second configuration inclined recess having an inclined inner surface inclined in the opposite direction to the first configuration inclined recess is provided on the inner surface, and further, a part of the balloon is in the first configuration inclined recess and the second configuration inclined recess. Stent delivery device which is characterized in that by entering. The first configuration inclined recess has a cross-sectional shape inclined toward the distal end side or the proximal end side of the stent, and the second configuration inclined recess is a cross-sectional shape inclined in the opposite direction to the first configuration inclined recess. The living organ dilator according to claim 1, wherein Each of the annular bodies includes a plurality of distal-end bending portions of the stent and a plurality of proximal-end bending portions of the stent, and the connection portion connects the adjacent bending portions of the adjacent annular bodies. And one end of the inclined recess is located at the bent portion of the one annular body adjacent to the connection portion, and the other end of the inclined recess is adjacent to the other annular body. The living organ dilator according to claim 1 or 2, which is located at a bent portion. The living organ dilator according to any one of claims 1 to 3, wherein the first form inclined concave portion has a substantially parallelogram-shaped cross-sectional shape inclined toward the distal end side or the proximal end side of the stent. 5. The living organ dilator according to claim 1, wherein the second form inclined recess has a substantially parallelogram-shaped cross-sectional shape inclined in the opposite direction to the first form inclined recess. The living organ dilator according to any one of claims 1 to 5, wherein both ends of the first form inclined recess and the second form inclined recess are substantially orthogonal to the central axis of the stent. The living organ dilator according to any one of claims 1 to 6, wherein the first form inclined recess and the second form inclined recess are wider at both ends than at the center. 8. The apparatus according to claim 1, further comprising a plurality of connection portions between the adjacent annular bodies, wherein the plurality of connection portions are provided with the first configuration inclined recess or the second configuration inclined recess. The biological organ dilator described. The said 1st form inclination recessed part and the said 2nd form inclination recessed part have an acute-angled end part, and this acute-angled edge part is a roundish edge part. The living organ dilator described in 1. The balloon is in a state in which the stent is not expanded and the balloon is slightly expanded, and a part of the balloon enters the inclined recess of the stent by expansion of the balloon. 9. The living organ dilator according to any one of 9 above. 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 1 to 10, which is a wavy linear body having a linear component extending.

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