JP2011067282A - Device for improving affected region of biological organ - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a device for improving an affected region of a biological organ which uses a self-expanding stent, favorably performs stent discharge operations and can contain the stent again after its partial exposure. <P>SOLUTION: The device 1 for improving the affected region of the biological organ is provided with the self-expanding stent 10, an inner tube body 3 having a guide wire lumen 61, and a sheath 2 which contains the stent 10 in its end. The stent 10 can be discharged by moving the sheath 2 toward the base end with respect to the tube body 3. The inner tube body 3 has many protrusions 5 which are arranged on the outer surface of a part corresponding to the stent containing part of the sheath 2. The protrusions 5 enter a side wall opening in the stent 10 and can abut on components of the stent 10 in the side wall opening in the stent 10. Only one protrusion 5 is arranged in the radial direction of the inner tube body 3 and multiple ones are arranged in the axial direction of the inner tube body 3 so that they may be nearly linear. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to an apparatus for improving a living organ lesion that is used to improve 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.

In-vivo stents are used to expand the stenosis or occlusion site and secure the lumen to treat various diseases caused by stenosis or occlusion of blood vessels or other in-vivo lumens. In general, it is a tubular medical device.
Hereinafter, a blood vessel will be described as an example, but the present invention is not limited to this.
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 differentiated between self-expandable and balloon-expandable stents by function and placement method. The balloon-expandable stent does not have an expansion function, and after the stent mounted on the balloon is inserted into the target site, the balloon is expanded, and the stent is expanded (plastically deformed) by the expansion force of the balloon, and is applied to the inner surface of the target lumen. Fix in close contact. This type of stent requires the above-described stent expansion operation. On the other hand, a self-expanding stent is a stent that has an expansion function, and is inserted into a living body in a thin and contracted state, and then returns to its original expanded state when released at a target site. The lumen shape is maintained by closely adhering to and fixing.
The purpose of the current stent placement is to return a blood vessel that has been stenotic for some reason to its original patency state, mainly to prevent and reduce restenosis that occurs after procedures such as PTCA. Is almost. In recent years, in order to further suppress the probability of restenosis, drug-eluting stents loaded with drugs such as immunosuppressants and anticancer drugs have been used, and their effects are generally known.
Most of the self-expanding stents are used in peripheral regions such as blood vessels of the lower limbs and carotid arteries. For example, there are some which have a form shown in Japanese Patent Publication No. 11-505441 (Patent Document 1).

Japanese Patent Publication No. 2006-522654 (Patent Document 2) discloses a catheter having an inner shaft, in which at least a part of the inner shaft forms a stent mounting region and is formed by a stent wall, and is in an unexpanded state. And a stent that changes into an expanded state, wherein in the non-expanded state, the stent is disposed around at least a portion of the stent mounting region and disposed around at least a portion of the inner shaft. And at least one band forming at least a part of the stent attachment region, wherein the band has a plurality of outer surfaces and a thickness (height) extending radially outward from the outer surface greater than the thickness of the stent. When the stent is in an unexpanded state, at least a portion of the stent is in the body region of the band. And engaging therewith are disposed around the least part, stent delivery system including a to enter the space in which the protrusions are formed by stent wall is disclosed.
FIG. 8 discloses that the band 10 is provided at the distal end portion of the stent and the proximal end portion of the stent.

Japanese National Patent Publication No. 11-505441 JP-T-2006-522654

In a device for improving a living organ lesion using a self-expandable stent as in Patent Document 1, positioning during placement is more difficult than a balloon-expandable stent due to the self-expandability of the stent, and the stent is more than the expandable device. A jumping phenomenon that jumps out may occur, and when this phenomenon occurs, the stent is arranged at a position shifted from a predetermined arrangement position. Also, during the stent placement procedure, the placement position may need to be readjusted after the stent has been ejected to some extent. However, with the thing like patent document 1, it is difficult to re-stor the stent in the organ for improving a living organ lesion.
In Patent Document 2, as soon as the distal end of the stent is exposed, the stent is separated from the distal band, and only the proximal band is engaged with the stent. In this state, when the sheath is pulled, all the frictional resistance between the stent and the sheath is loaded on the protrusions of the band, and the stent is deformed in the compressing direction, and the annular protrusion is in contact with the annular protrusion. An excessive load is applied to the part, and the stent may be damaged.
In addition, as a result of diligent examination by the present inventor, as in Patent Document 2, when the protrusion having a thickness (height) larger than the thickness of the stent is provided in an annular shape, the inner surface of the sheath is pushed up by each protrusion, It has been found that there is a possibility that the annular portion is locked and it is difficult to pull the sheath.
Accordingly, an object of the present invention is a biological organ lesion improvement device using a self-expanding stent, which has a good release operation of the stent, and after the stent has been exposed to some extent from the expansion device. In addition, the present invention provides a biological organ lesion improving device that can be stored in the expansion device again.

What achieves the above object is as follows.
(1) a stent having a large number of side wall openings, formed in a substantially cylindrical shape, compressed in the direction of the central axis when inserted into the living body, and expanded outwardly when placed in the living body to be restored to the shape before compression; An inner tube body having a guide wire lumen; and a stent housing tube body in which the stent is housed in a distal end portion; and the stent is disposed so as to cover the distal end portion of the inner tube body, and the stent housing tube body. A device for improving a lesion on a living organ that is capable of releasing the stent by moving the proximal side relative to the inner tube body,
The inner tube body has a protrusion holding portion having a plurality of protrusions provided on an outer surface of a portion corresponding to the stent storage portion of the stent storage tube body, and the protrusion enters the side wall opening of the stent. And can contact with the stent components within the side wall opening of the stent, and there is only one protrusion in the circumferential direction of the inner tube body, and the shaft of the inner tube body A biological organ lesion improvement device arranged in a large number so as to be substantially linear in the direction.

(2) The living organ lesion lesion improvement device according to (1), wherein the protrusion does not contact the inner surface of the stent housing tube body in a state where the stent housing tube body houses the stent. .
(3) The living organ lesion lesion improvement device according to (1) or (2), wherein a thickness of the protrusion is thinner than a thickness of the stent.
(4) In the projection, the projection located at the center of the projection holding portion is thinner than the projection located at the distal end side and the proximal end side of the projection holding portion. (1) The biological organ lesion-improving device according to any one of (3).
(5) The stent includes a distal end portion facing the distal end side of the stent storage tube body and a proximal end portion facing the proximal end side, and does not have a bending free end protruding at least on the proximal end side except the proximal end portion, (1) to (4), wherein the exposed portion can be re-accommodated in the stent accommodating tube by moving the stent accommodating tube after the distal end portion is exposed from the stent accommodating tube. The biological organ lesion improvement device according to any one of the above.
(6) Among the projections arranged in a large number so as to be substantially linear in the axial direction of the inner tube body, the projection located at the most distal end side is located within the distal end portion of the stent, and located at the most proximal end side. The living organ lesion lesion improvement device according to any one of (1) to (5), wherein the object is located in the proximal end portion of the stent.
(7) The stent includes a plurality of wavy struts extending in the axial direction from one end side to the other end side of the stent and arranged in the circumferential direction of the stent, and a plurality of connecting struts connecting the adjacent wavy struts. And the end portion of the corrugated strut is coupled to the end portion of the adjacent corrugated strut. The biological organ lesion improvement instrument according to any one of (1) to (6) above.
(8) The living organ lesion lesion improvement device according to any one of (1) to (7), wherein the protrusion is curved in a circumferential direction of the stent.
(9) The living organ lesion lesion improvement device according to any one of (1) to (7), wherein the protrusion has an elliptical shape extending in an axial direction of the stent.
(10) Said (1) thru | or (9) the said inner side tube body is provided with the front end side tube which has the said guide wire lumen, and the inner side tube body main body by which the front-end | tip part was fixed to the base end side of this front end side tube. The device for improving a living organ lesion according to any one of the above.

The biological organ lesion improvement instrument of the present invention has a large number of side wall openings, is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into the living body, and is expanded outwardly before being compressed by being placed in the living body. A stent that can be restored to its shape, an inner tube body having a guide wire lumen, and a stent housing tube body in which the stent is housed in the distal end portion, and the stent is disposed so as to cover the distal end portion of the inner tube body, In addition, the stent storage tube body is a device for improving a living organ lesion that can be released by moving the stent storage tube body to the proximal side with respect to the inner tube body, and the inner tube body stores the stent in the stent storage tube body. A protrusion holding portion having a large number of protrusions provided on the outer surface of the portion corresponding to the portion, the protrusion penetrates into the side wall opening of the stent, and the stent It is possible to make contact with the components of the stent within the wall opening, and there is only one protrusion in the circumferential direction of the inner tube body, and multiple arrangements are made so as to be almost linear in the axial direction of the inner tube body Has been.
In particular, in this biological organ lesion improving device, the inner tube body has a protrusion holding portion on the outer surface of the portion corresponding to the stent storage portion of the stent storage tube body, and the protrusion of the protrusion holding portion is formed on the inner tube body. A large number are arranged so that there is only one in the circumferential direction and a substantially linear shape in the axial direction. For this reason, the stent is not locked due to the protrusions, the stent release operation is good, and if the protrusions that contact the components of the stent remain, the stent storage tube body Even after the stent is partially exposed, the stent can be re-stored in the stent storage tube by engaging the projection and the stent component, and the position of the stent can be corrected. It can be reliably placed on the site.

FIG. 1 is a partially omitted front view of a biological organ lesion improvement instrument that is an embodiment of the present invention. FIG. 2 is a longitudinal sectional view of the biological organ lesion improvement instrument shown in FIG. FIG. 3 is a partially omitted front view of the stent storage tube body (sheath) of the biological organ lesion improvement instrument shown in FIG. FIG. 4 is a partially omitted front view of the inner tube body (including the stent) of the biological organ lesion improvement instrument shown in FIG. FIG. 5 is an explanatory diagram for explaining the vicinity of the distal end portion of the biological organ lesion improvement instrument shown in FIG. 1. FIG. 6 is an explanatory diagram for explaining a circumferential cross-sectional shape of the protrusion of the inner tube body. FIG. 7 is an explanatory diagram for explaining an axial cross-sectional shape of the protrusion of the inner tube body. FIG. 8 is an explanatory diagram for explaining an internal structure in the vicinity of an intermediate portion of the biological organ lesion improvement instrument shown in FIG. FIG. 9 is an explanatory diagram for explaining an inner tube body of the biological organ lesion improving instrument shown in FIG. 1. FIG. 10 is an explanatory diagram for explaining an inner tube body of a living organ lesion improving instrument according to another embodiment of the present invention. FIG. 11 is an explanatory diagram for explaining the vicinity of the distal end portion of a living organ lesion improving instrument according to another embodiment of the present invention. FIG. 12 is an explanatory diagram for explaining the circumferential cross-sectional shape of the protrusion of the inner tube body of the biological organ lesion improvement instrument of FIG. 11. FIG. 13 is an explanatory diagram for explaining an axial cross-sectional shape of the protrusion of the inner tube body of the biological organ lesion improvement instrument of FIG. FIG. 14 is an explanatory view for explaining the vicinity of the distal end portion of a living organ lesion improving instrument according to another embodiment of the present invention. FIG. 15 is an explanatory diagram for explaining the action of the biological organ lesion improvement instrument of the present invention. FIG. 16 is an explanatory diagram for explaining the operation of the biological organ lesion improving instrument of the present invention. FIG. 17 is a front view of an example of an in-vivo indwelling stent used in the biological organ lesion improving device of the present invention. 18 is a developed view of the in-vivo indwelling stent of FIG.

A living organ lesion improvement instrument of the present invention will be described with reference to an embodiment shown in the drawings.
The biological organ lesion improvement instrument 1 of the present invention has a large number of side wall openings, is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into the living body, and is expanded and compressed outward when placed in the living body. The stent 10 includes a stent 10 that can be restored to the previous shape, an inner tube body (shaft portion) 3 having a guide wire lumen 61, and a stent housing tube body (sheath) 2 in which the stent 10 is housed in the distal end portion. Is disposed so as to cover the distal end portion of the inner tube body 3, and the stent storage tube body 2 is moved to the proximal end side with respect to the inner tube body 3, so that the stent 10 can be released. Equipment. And the inner side tube body 3 has a processus | protrusion holding part which has many processus | protrusions 5 provided in the outer surface of the part corresponding to the stent storage site | part of the stent storage tube body 2. FIG. The protrusion 5 penetrates into the side wall opening of the stent 10 and can come into contact with a component of the stent 10 in the side wall opening of the stent 10. The number of the protrusions 5 is only one in the circumferential direction of the inner tube body 3, and many protrusions 5 are arranged so as to be substantially linear in the axial direction of the inner tube body 3.

In the living organ lesion lesion improvement instrument 1 of the illustrated embodiment, the inner tube body is constituted by the shaft portion 3, and the stent storage tube body is constituted by the sheath 2. Specifically, the biological organ lesion improvement instrument 1 of this embodiment has a large number of side wall openings, is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into the living body, and is removed when placed in the living body. A stent 10 that can be expanded to a shape before compression, a shaft portion 3 having a guide wire lumen 61, and a sheath 2 in which the stent 10 is housed in a distal end portion. It arrange | positions so that a front-end | tip part may be encapsulated.
In addition, a living body organ lesion improvement instrument 1 of the illustrated embodiment includes a stent 10 that can be expanded outwardly and restored to a shape before compression when placed in a living body, and a stent storage tube in which the stent 10 is stored in a distal end portion. A body (sheath) 2 and a shaft portion 3 through which the stent storage tube body (sheath) 2 is slidably inserted and the stent 10 is discharged from the distal end of the stent storage tube body (sheath) 2 are provided. The stent 10 includes a distal end portion that faces the distal end side of the stent housing tube body (sheath) 2 and a proximal end portion that faces the proximal end side, and further includes a bending free end that protrudes at least to the proximal end side except for the proximal end portion. The exposed portion can be re-stored in the stent storage tube body (sheath) 2 by moving the stent storage tube body (sheath) 2 after the distal end side portion is exposed from the stent storage tube body (sheath) 2. It has become a thing. The living organ lesion improving instrument 1 has a guide wire lumen 61 having one end opened at the distal end of the living organ lesion improving instrument and the other end opened proximally from the stent housing part of the sheath 2.

A biological organ lesion improvement instrument 1 according to the present invention includes a stent 10, a sheath (stent-containing tube body) 2 in which the stent 10 is housed in a distal end portion, and a shaft portion (inner tube body) through which the sheath 2 is slidably inserted. 3).
As shown in FIGS. 1 to 9, the sheath (stent housing tube body) 2 includes a sheath tube 21 and a sheath hub 22 fixed to the proximal end of the sheath tube 21.
As shown in FIGS. 1 to 9, the sheath tube 21 is a tubular body, and the front end and the rear end are open. The distal end opening functions as an outlet of the stent 10 when the stent 10 is placed at a lesion site in the body cavity. The stent 10 is released from the distal end opening, thereby releasing the stress load and expanding and restoring the shape before compression. The distal end portion of the sheath tube 21 serves as a stent housing portion 21a for housing the stent 10 therein. The sheath tube 21 includes a side hole 23 provided on the proximal end side with respect to the stent housing part 21a. The side hole 23 is for leading the guide wire to the outside.
The outer diameter of the sheath tube 21 is preferably about 0.5 to 4.0 mm, and particularly preferably 0.8 to 2.0 mm. Further, the inner diameter of the sheath tube 21 is preferably about 0.2 to 1.8 mm. The length of the sheath tube 21 is preferably 300 to 2500 mm, particularly about 300 to 2000 mm.
The material for forming the sheath tube 21 is, for example, polyethylene, polypropylene, nylon, polyethylene terephthalate, PTFE in consideration of physical properties required for the sheath tube (flexibility, hardness, strength, slipperiness, kink resistance, stretchability). Fluorine polymers such as ETFE, and thermoplastic elastomers are preferred. The thermoplastic elastomer is appropriately selected from nylon (for example, polyamide elastomer), urethane (for example, polyurethane elastomer), polyester (for example, polyethylene terephthalate elastomer), and olefin (for example, polyethylene elastomer, polypropylene elastomer). Is done.

Furthermore, it is preferable that the outer surface of the sheath 2 is subjected to a treatment for exhibiting lubricity. Examples of such treatment include hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone. Examples of the method include coating or fixing. Moreover, in order to improve the slidability between the stent 10 and the shaft portion 3 on the inner surface of the sheath tube 21, the above-described ones may be coated or fixed.
A sheath hub 22 is fixed to the proximal end portion of the sheath tube 21 as shown in FIGS. 1 to 3 and 9. As shown in FIG. 9, the sheath hub 22 includes a seal member 25 that can slide and liquid-tightly hold the shaft portion 3. The sheath hub 22 includes a side port 24.
As a constituent material of the sheath hub 22, a hard or semi-hard material is used. Examples of the hard or semi-rigid material include polycarbonate, polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer), styrene resin [for example, polystyrene, MS resin (methacrylate-styrene copolymer), MBS resin (methacrylate-butylene- Styrene copolymer)], synthetic resins such as polyester, metals such as stainless steel, aluminum or aluminum alloys can be used.
An elastic material is used as a constituent material of the seal member 25 and an elastic ring 69 described later. Examples of elastic materials include synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, rubbers such as natural rubber such as latex rubber, olefin elastomers (eg, polyethylene elastomer, polypropylene elastomer), polyamide elastomers, and styrene elastomers (eg, , Styrene-butadiene-styrene copolymer, styrene-isoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), synthetic resin elastomers such as polyurethane, urethane elastomer, and fluororesin elastomer.
Reinforcing members 26 and 27 extending from the distal end of the sheath hub to the distal end side are provided at the distal end of the sheath hub 22.

As shown in FIGS. 1 to 6, the shaft portion (inner tube body) 3 is provided at the distal end of the shaft main body 33, the distal end of the shaft main body 33, and protrudes from the distal end of the sheath 2, and the shaft main body 33. And a shaft hub 30 fixed to the base end of the shaft.
In this embodiment, the shaft portion 3 is provided with a proximal-side opening of a guide wire lumen that opens at a side portion proximal to the stent housing site of the sheath 2, and the sheath 2 is proximal to the stent housing site. A sheath side hole provided on the side is provided, and a guide wire can be inserted through the sheath side hole and the proximal end side opening.
The distal tube 31 protrudes from the distal end of the sheath 2 as shown in FIG. The distal tube 31 is provided with a stopper 32 that prevents the sheath 2 from moving in the distal direction. As shown in FIG. 8, the proximal end portion of the distal end side tube 31 is curved, enters the side hole 23 of the sheath tube 21, and is detachably engaged. The outer diameter of the distal tube 31 is preferably 0.2 mm to 1.8 mm. Moreover, it is preferable that the front-end | tip part of the front end side stopper 32 is diameter-reduced toward the front end side, as shown in FIG. The outer diameter of the maximum diameter portion of the stopper 32 is preferably 0.5 to 4.0 mm. Moreover, it is preferable that the base end part of the stopper 32 is also diameter-reduced toward the base end side, as shown in FIG. The distal tube 31 has a guide wire lumen 61 extending from the distal end to the proximal end, and the proximal opening 62 is positioned 10 to 400 mm proximal from the distal end of the distal tube 31. In particular, 50 to 350 mm is preferable. Moreover, it is preferable that the position of the base end opening 62 is about 50 to 250 mm from the rear end of the stent 10 to be arranged (in other words, the rear end of the stent storage site).

The stent 10 used in the present invention is a so-called self-expanding stent that has a large number of openings on the side surface and can be expanded outwardly and restored to its pre-compression shape when placed in vivo. Further, the stent 10 includes a distal end portion facing the distal end side of the sheath 2 and a proximal end portion facing the proximal end side, and further does not substantially have a bending free end protruding at least at the proximal end side except for the proximal end portion. In other words, the sheath 2 can be re-stored in the sheath 2 by moving the sheath 2 after the tip portion is exposed from the sheath 2.
The stent to be used may be one that does not have a free end by combining the apex of the bent portion on the base end side or the vicinity of the apex with another linear component. Further, the stent used may be as shown in FIGS. FIG. 17 is a front view of an example of an in-vivo indwelling stent used in the biological organ lesion improving device of the present invention. 18 is a developed view of the in-vivo indwelling stent of FIG.
The stent 10 extends in a predetermined long axis direction while connecting the adjacent wavy struts 13 and 14 that are axially extended from one end side to the other end side of the stent and arranged in the circumferential direction of the stent. One or more connecting struts 15 are provided, and the ends of the wavy struts 13, 14 are coupled to the ends of the adjacent wavy struts. The stent 10 includes a large number of openings formed between the struts.

In particular, the stent 10 shown in FIGS. 17 and 18 includes a plurality of first wavy struts 13 extending in the axial direction from one end side to the other end side of the stent 10 and arranged in the circumferential direction of the stent, and the first wavy struts 13. A plurality of second wavy struts 14 that extend in the axial direction from one end side to the other end side of the stent and are arranged in the circumferential direction of the stent, and the first wavy struts 13 and the second wavy struts 14 that are adjacent to each other. One or a plurality of connecting struts 15 that are connected and extend in a predetermined major axis direction are provided. The apex of the second wavy strut 14 is shifted by a predetermined length in the axial direction of the stent with respect to the apex of the first wavy strut 13 that is close to the circumferential direction of the stent 10 and curves in the same direction. . Further, the end portions 13a and 13b of the first wavy strut 13 are coupled to the end portions 14a and 14b of the adjacent second wavy struts.
The stent 10 of this embodiment is a so-called self-expanding stent that is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into a living body, and expands outward when placed in the living body to restore the shape before compression. ing.

The first wavy strut 13 extends in the axial direction substantially parallel to the central axis of the stent. A plurality of first wavy struts 13 are arranged in the circumferential direction of the stent. The number of the first wavy struts 13 is preferably 3 or more, particularly about 3 to 8. Further, the plurality of first wavy struts 13 are preferably arranged so as to be substantially equiangular with respect to the central axis of the stent.
The second wavy strut 14 also extends in the axial direction substantially parallel to the central axis of the stent. A plurality of second wavy struts 14 are arranged in the circumferential direction of the stent, and each second wavy strut 14 is arranged between each first wavy strut. The number of the second wavy struts 14 is preferably 3 or more, particularly about 3 to 8. Furthermore, it is preferable that the plurality of second wavy struts 14 are arranged so as to be substantially equiangular with respect to the central axis of the stent. The number of second wavy struts 14 is the same as the number of first wavy struts.
The stent 10 includes one or a plurality of connection struts 15 that connect the adjacent first wavy struts 13 and second wavy struts 14 and extend in a predetermined major axis direction. In particular, in the stent 10 of this embodiment, the connection strut 15 has one end near the inflection point of one wavy strut, and the other end in a region slightly beyond the apex of the adjacent wavy strut. And extending in the axial direction and curved in the same direction as the apex of the other wavy strut. Specifically, as shown in FIG. 18, the connection strut 15 includes a curved first connection strut 15 a having a vertex directed toward one side in the circumferential direction of the stent 10 and a vertex directed toward the other side in the circumferential direction of the stent 10. And a curved second connection strut 15b. The connecting strut 15 is curved in an arc shape and has substantially the same radius as the arc of the curved portion of the first wavy strut 13 or the second wavy strut 14 that is close to the circumferential direction of the stent 10.

And the stent 10 of this Example is provided with the connection part 16 couple | bonded with the edge part of any 2nd waved strut which adjoins the one end side edge part and other end side edge part of all the 1st waved struts. . Specifically, one end 13a of the first wavy strut of the stent 10 is adjacent to one second wavy strut 14 (specifically, the second wavy strut located adjacent to the other side in the circumferential direction). 14) and an end portion 14 a on one end side and a connecting portion 16. Further, the other end 13b of the first wavy strut is the other end of the adjacent second wavy strut 14 (specifically, the second wavy strut 14 which is close and located on one side in the circumferential direction). The end portion 14 b on the side is coupled to the coupling portion 16. That is, the combination of the first wavy strut 13 and the second wavy strut 14 to be coupled is different (shifted one by one) in the coupling portion 16 on the one end side and the coupling portion 16 on the other end side.
A radiopaque marker 17 is attached to the coupling portion 16. In this embodiment, the coupling portion 16 includes two frame portions that extend in parallel at a predetermined distance in the end direction, and the radiopaque marker 17 is substantially the whole or one of the two frame portions. The part is encapsulated. The radiopaque marker 17 has a thin rectangular parallelepiped shape, and is housed in the two frame portions and is fixed to the two frame portions by being depressed in the center. As a material for forming the radiopaque marker, one or two selected from the group of elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, and hafnium are used. More than one kind (alloy) can be preferably used.

As a constituent material of the stent 10, a super elastic metal is suitable. As the superelastic metal, a superelastic alloy is preferably used. The superelastic alloy here is generally called a shape memory alloy, and exhibits superelasticity at least at a living body temperature (around 37 ° C.). Particularly preferably, a Ti—Ni alloy of 49 to 53 atomic% Ni, a Cu—Zn alloy of 38.5 to 41.5 wt% Zn, and a Cu—Zn—X alloy of 1 to 10 wt% X (X = Be, A super elastic metal body such as Si, Sn, Al, Ga), Ni-Al alloy of 36-38 atomic% Al is preferably used. Particularly preferred is the Ti—Ni alloy described above. Further, a Ti—Ni—X alloy in which a part of the Ti—Ni alloy is substituted with 0.01 to 10.0% X (X = Co, Fe, Mn, Cr, V, Al, Nb, W, B, etc.) Or a Ti—Ni—X alloy (X = Cu, Pb, Zr) in which a part of the Ti—Ni alloy is substituted by 0.01 to 30.0% atoms, and the cold work rate Alternatively, mechanical properties can be appropriately changed by selecting conditions for the final heat treatment. Further, the mechanical characteristics can be appropriately changed by selecting the cold work rate and / or the final heat treatment conditions using the Ti—Ni—X alloy. The buckling strength (yield stress during loading) of the superelastic alloy used is 5 to 200 kg / mm ² (22 ° C.), more preferably 8 to 150 kg / mm ^2. Restoring stress (yield stress during unloading) ) Is 3 to 180 kg / mm ² (22 ° C.), more preferably 5 to 130 kg / mm ² . Superelasticity here means that even if it is deformed (bending, pulling, compressing) to a region where normal metal is plastically deformed at the operating temperature, it will recover to its almost uncompressed shape without the need for heating after the deformation is released. It means to do.
The stent preferably has a compressed diameter of about 0.5 to 1.8 mm, and more preferably 0.6 to 1.4 mm. Further, the length of the stent when not compressed is preferably about 5 to 200 mm, and particularly preferably 8.0 to 100.0 mm. Further, the diameter of the stent when not compressed is preferably about 1.5 to 6.0 mm, and more preferably 2.0 to 5.0 mm. Furthermore, the thickness of the stent is preferably about 0.05 to 0.15 mm, and particularly preferably 0.05 to 0.40 mm. The width of the wavy strut is preferably 0.01 to 1.00 mm, particularly preferably 0.05 to 0.2 mm. The surface of the wavy strut is preferably processed smoothly, and smoothing by electropolishing is more preferable. Further, the radial strength of the stent is preferably 0.1 to 30.0 N / cm, and particularly preferably 0.5 to 5.0 N / cm.

  And the inner side tube body 3 has a processus | protrusion holding part which has many processus | protrusions 5 provided in the outer surface of the part corresponding to the stent storage site | part of the stent storage tube body 2. FIG. The protrusion 5 penetrates into the side wall opening of the stent 10 and can come into contact with a component of the stent 10 in the side wall opening of the stent 10. There is only one protrusion 5 in the circumferential direction of the inner tube body 3, and it is substantially linear in the axial direction of the inner tube body 3 (in other words, in a predetermined width region in series or parallel to the central axis of the stent). So many are arranged. The stent 10 is slidable with respect to the stent housing tube body 2, and the stent 10 is engaged with the protrusion 5 to the inner tube body 3 (specifically, the distal end side tube 31). On the other hand, it is impossible to slide.

And the living body organ lesion part improvement instrument 1 of this embodiment is provided with a protrusion holding portion provided on the outer surface of a predetermined region of the distal end portion of the distal tube 31 (a portion corresponding to the stent housing portion of the stent housing tube body 2). Have A large number of protrusions are provided on the outer surface of the distal tube 31 serving as a protrusion holding portion so as to be substantially linear in the axial direction of the stent. Further, only one protrusion 5 is provided in the circumferential direction of the distal end side tube 31.
Each of these protrusions 5 penetrates into a side wall opening formed between components (specifically, struts) constituting the stent 10. Furthermore, each protrusion 5 can abut on, specifically, engage with a component (strut) of the stent 10 in the side wall opening of the stent 10. As shown in FIGS. 1 and 5, all of the protrusions 5 penetrate into the side wall openings of the stent 10 in a state where the stent housing tube body 2 completely houses the stent 10. In this state, the protrusion may be in contact with or engaged with a component (strut) of the stent 10. In addition, the protrusion 5 penetrates into the side wall opening of the stent 10 when the stent housing tube body 2 completely houses the stent 10, but does not come into contact with the components (struts) of the stent 10. It may be abutted and engaged when the stent housing tube body is moved to the proximal end side (when the stent is released).
In the living organ lesion lesion improvement instrument 1 of this embodiment, only one protrusion 5 is provided in the circumferential direction of the distal end side tube 31. A large number of protrusions 5 are arranged so as to be substantially linear in the axial direction of the distal end side tube 31. In addition, if it is located in the predetermined area (for example, area | region within 90 degree | times with respect to the center axis | shaft of a stent) in the axial direction of the front end side tube 31, the substantially linear form will shift | deviate somewhat in the area | region. It may be a thing.

Moreover, it is desirable to arrange the protrusions 5 at substantially equal intervals. In this case, the protrusion interval is preferably 0.05 to 0.5 mm. In addition, the number of protrusions in the protrusion holding portion is preferably about 3 to 10 although it varies depending on the length of the protrusion holding portion (the length of the stent). Note that more protrusions 5 may be arranged on the proximal end side than on the distal end side. As shown in FIG. 6, the protrusion 5 does not contact the inner surface of the sheath 2 when the sheath 2 (stent housing tube body) houses the stent 10. For this reason, friction resistance does not occur when the sheath 2 moves between the protrusion 5 and the inner surface of the sheath 2. The thickness (height) of the protrusion 5 is preferably thinner than the thickness of the stent 10. Furthermore, as shown in FIG. 6, the protrusion preferably has a width that decreases toward the center in the circumferential cross section. Specifically, the protrusion 5 is an inclined surface whose side surface is inclined toward the central direction. By doing so, the protrusion 5 can easily enter the side wall opening of the stent 10.
Further, as shown in FIG. 7, the protrusion 5 has a smaller thickness in the protrusion 5 located in the center of the protrusion holding part than in the protrusion 5 located on the distal end side and the proximal end side of the protrusion holding part. It has become. In this way, when the sheath moves to the proximal end side, the protrusion 5 can reliably engage with the strut of the stent 10 and the deformation of the strut of the stent 10 by the protrusion 5 can be reliably prevented.
Further, the protrusion 5 for reducing the thickness is preferably about 1/100 to 1/10 of the entire length of the protrusion holding portion.
Furthermore, in the living body organ lesion part improvement instrument 1 of this embodiment, the projection is arranged on the most distal side among the many protrusions arranged so as to be substantially linear in the axial direction of the distal tube 31 (inner tube body 3). What is to be located is located in the distal end portion of the stent, and what is located on the most proximal side is located in the proximal end portion of the stent. Specifically, the protrusion 5 positioned closest to the distal end is disposed in a portion that is a predetermined length proximal side from the distal end of the stent, and the protrusion 5 positioned closest to the proximal end is a distal end having a predetermined length from the proximal end of the stent. It is arranged inside the part that becomes the side.
In the living body organ lesion improvement instrument 1 of this embodiment, the protrusion 5 is curved in the circumferential direction so as to correspond to the curved shape of the strut of the stent 10. For this reason, the contact property with the strut of the stent 10 is made favorable. The protrusion 5 is formed in a linear shape. Further, the central portion of the projection 5 formed in a bent line shape may be narrower than both end portions. Further, when the protrusion 5 has a bent line shape as described above, the bent portion is preferably substantially directed in the circumferential direction of the stent. Furthermore, it is preferable that the bent portions of the protrusions adjacent in the axial direction of the stent (improvement device) face different circumferential directions (specifically, substantially opposite directions).

Also. The form of the protrusion may be the same as the biological organ lesion improving instrument 20 of the embodiment shown in FIGS. 11 to 13.
In the living organ lesion improving instrument 20 of this embodiment, the protrusion 5 a has an elliptical shape (oval) extending in the axial direction of the stent 10. The protrusion 5 a has a thickness (height) that is thinner than the thickness of the stent 10. Furthermore, as shown in FIG. 12, the protrusion preferably has a width that becomes narrower toward the center in the circumferential cross section. Specifically, the protrusion 5a is a curved surface whose side surface is curved toward the center. By doing so, the protrusion 5 can easily enter the side wall opening of the stent 10. Moreover, as shown in FIG. 13, it is preferable that the protrusion 5a has a chamfered end in the axial direction. By doing so, the protrusion 5 can easily enter the side wall opening of the stent 10. Further, in the protrusion 5a, the protrusion located at the center of the protrusion holding part is thinner than the protrusion 5a located on the distal end side and the base end side of the protrusion holding part.
Furthermore, as in the biological organ lesion improvement instrument 40 of the embodiment shown in FIG. 14, the protrusion is located at the center of the protrusion holding part from the size of the protrusion 5a located on the distal end side and the proximal end side of the protrusion holding part. The size of the protrusion 5b that is positioned may be smaller.

As a material for forming the protrusions, metal wires such as stainless steel wire (preferably, high-strength stainless steel for spring) and piano wire (preferably, nickel-plated or chrome-plated piano wire), polyamide, polyimide A relatively high-rigidity polymer material such as ultrahigh molecular weight polyethylene, polypropylene, or fluorine resin is used.
Further, the protrusion 5 may have X-ray contrast properties. Thereby, the position near the proximal end of the stent can be grasped under X-ray contrast, and the procedure becomes easier. The X-ray contrast property can be imparted by forming the projections 5 with an X-ray contrast material or coating the X-ray contrast material. As the X-ray contrast material, for example, gold, platinum, platinum-iridium alloy, silver, stainless steel, platinum, or an alloy thereof is suitable.

In the living body organ lesion improvement instrument 1 of this embodiment, the inner tube body 3 (specifically, the distal side tube 31) is a guide wire on the proximal side from the stent storage site of the stent storage tube body 2. An opening 62 is provided in communication with the lumen.
Moreover, it is preferable that the front end side tube 31 is equipped with the reinforcement layer 31a in the part which becomes a base end side at least from the rear-end part of a stent. In this embodiment, the reinforcing layer 31 a is provided over the entire distal end side tube 31. Note that the reinforcing layer 31 a may not be provided at the most distal end portion of the distal end side tube 31. The reinforcing layer 31a is preferably a mesh-like reinforcing layer. The mesh-like reinforcing layer is preferably formed by blade lines. For example, it is a wire blade and can be formed of a metal wire such as stainless steel, an elastic metal, a superelastic alloy, a shape memory alloy having a wire diameter of 0.01 to 0.2 mm, preferably 0.03 to 0.1 mm. Or you may form with synthetic fibers, such as a polyamide fiber, a polyester fiber, and a polypropylene fiber.

The shaft body 33 has a distal end portion fixed to the proximal end portion of the distal end side tube 31, a main body portion extending toward the proximal end side by a predetermined length, and a proximal end portion protruding from the shaft hub 30. Yes. In this embodiment, the shaft main body 33 has a small diameter portion at the distal end portion fixed to the distal end side tube 31, and the main body portion and the base end portion have a larger outer diameter than the small diameter portion. It has become. In this embodiment, the distal end portion of the shaft body 33 is fixed to the side surface of the distal end side tube 31 by a heat shrinkable tube 63.
The length of the shaft portion 3 is preferably about 400 to 2500 mm, and particularly preferably 400 to 2200 mm. Moreover, as an outer diameter of the main-body part of the shaft main body 33, about 1.0-2.5 mm is preferable, and 1.0-2.0 mm is especially preferable. Further, the length of the distal end side tube 31 is preferably about 10 to 400 mm, particularly preferably 50 to 350 mm, and the outer diameter is preferably about 0.2 to 2.0 mm. Further, the inner diameter of the lumen 61 is preferably about 0.2 to 2.0 mm, and particularly preferably 0.3 to 1.0 mm.

The shaft body 33 may be any solid tube. A coil shaft may also be used. The material for forming the shaft portion 3 is preferably a material having hardness and a certain degree of flexibility. For example, metal wires or metal pipes such as stainless steel and superelastic metal, polyethylene, polypropylene, nylon, polyethylene Fluoropolymers such as terephthalate and ETFE, rod-like bodies such as PEEK (polyether ether ketone) and polyimide, or tubular bodies can be suitably used. Note that the outer surface of the shaft portion 3 may be coated with a resin having biocompatibility, particularly antithrombogenicity. As the antithrombogenic material, for example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer), or the like can be preferably used.
Furthermore, it is preferable that the outer surface of the part which may protrude from the sheath 2 among the shaft parts 3 has lubricity. For this purpose, for example, coated with a hydrophilic polymer such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone, or It may be fixed. Further, the above may be coated or fixed on the entire outer surface of the shaft portion 3. Furthermore, in order to improve the slidability with the guide wire, the above may be coated or fixed on the inner surface of the shaft portion 3.

  The shaft body 33 penetrates through the sheath 2 and protrudes from the rear end opening of the sheath 2. A shaft hub 30 is fixed to the proximal end portion of the shaft body 33 as shown in FIGS. In this embodiment, a fixing ring 66 is fixed to the shaft body 33 as shown in FIG. Further, a proximal end tube 34 extending from the hub 30 toward the distal end side is fixed to the shaft hub 30. The distal end portion of the proximal end tube 34 is fixed to the fixing ring 66. An elastic ring 69 is fixed to the proximal end of the proximal end tube 34 (inside the shaft hub 30). Furthermore, in this embodiment, a second fixing ring 68 is provided on the distal end side of the predetermined length from the fixing ring 66. An intermediate tube 67 is disposed between the fixing ring 66 and the second fixing ring 68. The intermediate tube 67 is not fixed to any of the shaft main body 33 and the sheath tube 21, and can contact the fixing ring 66 and the second fixing ring 68. By providing such an intermediate tube, the sliding of the sheath becomes good. The intermediate tube 67 preferably has a low friction surface. Specifically, for example, a tube formed of a fluorine-based polymer such as polyethylene, polypropylene, nylon, polyethylene terephthalate, PTFE, ETFE or the like is preferable.

Next, the effect | action of the biological organ lesion improvement instrument of this invention is demonstrated using FIG. 15 and FIG.
The organ for organ lesion improvement 1 having a guide wire 65 inserted into the distal tube 31 is inserted into the blood vessel to be treated, and the stent is allowed to reach the indwelling site. In this state, the entire stent 10 is housed in the sheath 2. Then, by sliding the sheath 2 to the proximal end side, as shown in FIG. 15, the stent 10 has a part or all of the protrusions 5 abutting and engaging with the components (struts) of the stent 10. Thus, the movement toward the proximal end side is restricted and exposed from the distal end opening of the sheath 2. The stent 10 exposed from the sheath 2 expands by a self-expanding force and tries to restore the form before compression. However, in this biological organ lesion improvement instrument, since the protrusion 5 has entered the side wall opening of the stent 10 in the unexposed portion, the readjustment position of the stent 10 is necessary. As shown in FIG. 16, the stent 10 can be re-stored in the sheath by sliding the sheath 2 in the distal direction. And after adjusting so that a stent part may become a suitable position, the stent 10 is exposed from the front-end | tip opening of the sheath 2 by sliding the sheath 2 to the proximal end again. Then, by sliding the sheath 2 toward the proximal end until the proximal end of the stent is exposed, the stent is completely released from the sheath and detached from the shaft portion 3.

1 Biological organ lesion improvement device 2 Stent storage tube body (sheath)
3 Shaft 5 Protrusion 10 Stent

Claims (10)

A stent having a number of side wall openings, formed in a substantially cylindrical shape, compressed in the direction of the central axis when inserted into the living body, and expanded outwardly when placed in the living body and restored to its original shape before compression, and a guide wire lumen An inner tube body, and a stent housing tube body in which the stent is housed in a distal end portion, the stent is disposed so as to cover the distal end portion of the inner tube body, and the stent housing tube body is disposed on the inner side body. A biological organ lesion ameliorating device capable of releasing the stent by being moved proximally with respect to the tube body,
The inner tube body has a protrusion holding portion having a plurality of protrusions provided on an outer surface of a portion corresponding to the stent storage portion of the stent storage tube body, and the protrusion enters the side wall opening of the stent. And can contact with the stent components within the side wall opening of the stent, and there is only one protrusion in the circumferential direction of the inner tube body, and the shaft of the inner tube body A biological organ lesion-improving device characterized by being arranged in a large number so as to be substantially linear in the direction. The living organ lesion lesion improvement device according to claim 1, wherein the protrusion does not contact the inner surface of the stent housing tube body in a state where the stent housing tube body houses the stent. The instrument for improving a living organ lesion according to claim 1 or 2, wherein the thickness of the protrusion is thinner than the thickness of the stent. 2. The projection is positioned at a central portion of the projection holding portion with a smaller thickness than the projections located on the distal end side and the proximal end side of the projection holding portion. 3. The device for improving a living organ lesion according to any one of 3 above. The stent includes a distal end portion facing the distal end side of the stent housing tube body and a proximal end portion facing the proximal end side, and does not have at least a free bending end protruding toward the proximal end except the proximal end portion, and The living body according to any one of claims 1 to 4, wherein the exposed portion can be re-stored in the stent storage tube body by moving the stent storage tube body after the distal end portion is exposed from the tube body. An instrument for improving organ lesions. Of the many protrusions arranged so as to be substantially linear in the axial direction of the inner tube body, the protrusion located at the most distal side is located within the distal end portion of the stent, and the protrusion located at the most proximal side is the The biological organ lesion-improving device according to any one of claims 1 to 5, which is located in a proximal end portion of the stent. The stent includes an undulating strut extending in the axial direction from one end side to the other end side of the stent and arranged in a plurality in the circumferential direction of the stent, and a plurality of connecting struts connecting the adjacent undulating struts, The living organ lesion lesion improvement device according to any one of claims 1 to 6, wherein an end portion of the wavy strut is connected to an end portion of an adjacent wavy strut. The living organ lesion lesion improvement device according to any one of claims 1 to 7, wherein the protrusion is curved in a circumferential direction of the stent. The living organ lesion lesion improvement device according to any one of claims 1 to 7, wherein the protrusion has an elliptical shape extending in an axial direction of the stent. The said inner tube body is provided with the front end side tube which has the said guide wire lumen | rumen, and the inner tube body main body by which the front-end | tip part was fixed to the base end side of this front end side tube. An instrument for improving lesions in living organs.

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