WO2016143446A1

WO2016143446A1 - Medical device

Info

Publication number: WO2016143446A1
Application number: PCT/JP2016/053720
Authority: WO
Inventors: 和俊大橋; 賢二大山
Original assignee: テルモ株式会社
Priority date: 2015-03-11
Filing date: 2016-02-08
Publication date: 2016-09-15
Also published as: JP2018068320A

Abstract

[Problem] To provide a medical device capable of delivering a medical device a long distance in a living body lumen while improving operability. [Solution] A medical device (10) has: a shaft section (100) for insertion into a living body organ, the shaft section being provided with an inner tube (110) and an outer tube (120) arranged so as to cover the external peripheral surface of the inner tube; a movement section (200) for extendably/contractibly deforming along the axial direction of the shaft section to thereby move the outer tube along the axial direction in relative fashion to the inner tube, the movement section being arranged between the inner tube and the outer tube; and a treatment section (300) that is accommodated between the inner tube and the outer tube prior to the extendable/contractible deformation of the movement section and that is exposed from the shaft section when the movement section has extendably/contractibly deformed to carry out a predetermined treatment of a to-be-treated location inside the living body organ.

Description

Medical equipment

The present invention relates to a medical device.

A medical instrument such as a stent or a drug-eluting balloon may be used to perform a local treatment on a site to be treated such as a stenosis occurring in a living organ. When these medical devices are used, a delivery apparatus including a long catheter having flexibility is generally used in order to enable delivery to a desired position in a living body lumen.

For example, Patent Document 1 discloses a stent delivery that enables delivery to a treatment target site in a living body lumen in a state where a stent (self-expanding stent) is accommodated on the distal end side of a catheter including an outer tube and an inner tube. An apparatus is disclosed. In this stent delivery device, the stent is exposed from the catheter by a simple operation of pushing and pulling the pulling wire fixed to the outer tube by a hand operation, and a treatment for expanding the stenosis portion as a treatment target site by the stent is performed. Implementation is possible.

International Publication No. 2010/093017

For example, when a medical device such as a stent is transferred to a treatment target site that is relatively far from the site where the catheter is inserted in the living body using the delivery device as described above, the length of the catheter is designed to be long. Therefore, it is necessary to design the length of the pulling wire to be long. When the pulling wire is lengthened, the pulling wire is likely to be twisted or bent, and the responsiveness of the catheter tip to the operation at hand is lowered, and the operability may be impaired.

Accordingly, the present invention has been made to solve the above-described problems, and provides a medical device excellent in operability that can suitably deliver a medical instrument to a desired position in a living organ. Objective.

The medical device according to the present invention that achieves the above object includes an inner tube and an outer tube disposed so as to cover an outer peripheral surface of the inner tube, a shaft portion that is inserted into a living organ, and the inner tube And a moving unit that is disposed between the outer tube and the outer tube, and moves relative to the inner tube along the axial direction by expanding and contracting along the axial direction of the shaft unit. Before the moving part is expanded and contracted, it is accommodated between the inner tube and the outer tube, and when the moving part is expanded and contracted, it is exposed from the shaft part and is applied to the treatment target site in the living organ. And a treatment unit for performing a predetermined treatment.

According to the medical device configured as described above, the outer tube can be moved relative to the inner tube by expanding and contracting the moving unit disposed in the shaft portion. Compared with the case where the traction force to be moved is transmitted from the hand side, the treatment portion can be treated by exposing the treatment portion more reliably and easily from the shaft portion.

FIG. 1 is an overall configuration diagram of a medical device according to an embodiment of the present invention. 2 is a cross-sectional view of the distal end portion of the medical device shown in FIG. FIG. 3 is a cross-sectional view of the medical device according to the first embodiment. FIG. 3A shows a state before the moving part is stretched and deformed, and FIG. 3B shows that the moving part is stretched and deformed. Shown later. FIG. 4 shows a distal end portion of the medical device related to the proportionality, and FIGS. 4A to 4D are diagrams for explaining operations by the medical device related to the proportionality. FIG. 5 is a cross-sectional view of a medical device according to a modified example of the first embodiment. FIG. 5 (A) shows a state before the moving part expands and contracts, and FIG. 5 (B) shows the moving part. The state after elastic deformation is shown. FIG. 6 is a cross-sectional view of the medical device according to the second embodiment. FIG. 6 (A) shows a state before the moving part is stretched and deformed, and FIG. FIG. 6C shows a state in which a portion exposed from the shaft portion of the moving portion is further expanded and contracted. FIG. 7 is a cross-sectional view of the medical device according to the third embodiment. FIG. 7 (A) shows a state before the moving part is stretched and deformed, and FIG. 7 (B) shows that the moving part is stretched and deformed. Shown later. FIG. 8 is a cross-sectional view of a medical device according to a modification of the third embodiment. FIG. 8 (A) shows a state before the moving part is expanded and contracted, and FIG. 8 (B) shows the moving part. The state after elastic deformation is shown.

Hereinafter, embodiments and modifications of the present invention will be described with reference to the accompanying drawings. In addition, the following description does not limit the technical scope and terms used in the claims. In addition, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from actual ratios.

(First embodiment)
FIG. 1 is an overall configuration diagram of a stent delivery system 10 (corresponding to a medical device) according to an embodiment of the present invention. FIG. 2 is a cross-sectional view of the distal end portion of the stent delivery system 10 shown in FIG. FIG. 3 is a cross-sectional view of the stent delivery system 10 according to the first embodiment. FIG. 3 (A) shows a state before the moving part 200 is stretched and deformed, and FIG. 3 (B) shows the moving part 200. Shows the state after the elastic deformation. FIG. 4 shows the distal end side portion of the stent delivery system 10 ′ according to the proportionality, and FIGS. 4A to 4D are diagrams for explaining the operation by the stent delivery system 10 ′ according to the proportionality. .

The stent delivery system 10 is used to place the stent 300 in a living body lumen.

The stent 300 is generally used for dilated treatment of lesions (corresponding to a site to be treated) such as stenosis or occlusion occurring in a biological lumen (biological organ) such as a blood vessel, bile duct, trachea, esophagus, or urethra. used. The stent 300 is expanded by a balloon 210 mounted with the stent 300 (balloon expandable stent 320), and is expanded by removing a member that suppresses expansion from the outside (self-expandable stent 310). There is. In the present embodiment, an example using the self-expandable stent 310 will be described, and in an embodiment 2 described later, an example using the balloon expandable stent 320 will be described (see FIG. 6).

As shown in FIG. 1, the stent delivery system 10 according to the present embodiment is disposed between a shaft portion 100 to be inserted into a living body lumen, an inner tube 110 and an outer tube 120, and an axis of the shaft portion 100. The movable portion 200 that moves the inner tube 110 relative to the outer tube 120 along the axial direction by expanding and contracting along the direction, and a predetermined treatment on the treatment target site in the living body lumen A self-expanding stent 310 (corresponding to a treatment unit) to be implemented and a hub 400 that operates expansion and contraction of the moving unit 200 are included. Moreover, it has the tube member 510 mentioned later which transfers a pressurization medium, and the insertion pipe | tube 520 in which the tube member 510 is penetrated.

In this specification, the side inserted into the body cavity is referred to as the distal end side (the direction of arrow A shown in the figure), and the side on which the hub 400 serving as the proximal side is provided is the proximal end side (the direction of arrow B shown in the figure). ). The longitudinal direction of the shaft portion 100 is referred to as the axial direction.

The shaft portion 100 includes an inner tube 110 and an outer tube 120 disposed so as to cover the outer peripheral surface of the inner tube 110, and is inserted into a living body lumen.

As shown in FIG. 2, the inner tube 110 is constituted by a long tubular body in which a guide wire lumen 110a penetrating from the distal end to the proximal end is formed. A guide wire (not shown) that guides the stent delivery system 10 to a stenosis in the living body lumen is inserted through the guide wire lumen 110a.

A tip member 130 is disposed at the forefront of the inner tube 110. The tip member 130 is fixed to the tip portion of the inner tube 110 by a stopper 131. The stopper 131 is embedded in the tip member 130 and prevents the tip member 130 from being detached. The stopper 131 is preferably formed of a metal such as stainless steel, for example. The distal end member 130 has a shape that gradually decreases in diameter toward the distal end, and is easily formed into a living body lumen. An opening 110 b is formed at the tip of the tip member 130. The tip member 130 may be constituted by a member separate from the inner tube 110 or may be constituted integrally by the same member as the inner tube 110.

As shown in FIG. 2, on the outer surface of the inner tube 110, a distal-side movement restricting portion 111 that abuts on the distal end side of the self-expandable stent 310 and restricts movement toward the distal end side, and a first fixing portion described later 220 is fixed. The distal end side movement restricting portion 111 and the first fixing portion 220 are formed in an annular shape around the longitudinal axis.

The distal end side movement restricting portion 111 has a tapered surface whose proximal end portion is reduced in diameter toward the proximal end side. For this reason, when releasing the self-expanding stent 310, which will be described later, the distal-side movement restricting portion 111 does not become an obstacle, and the stent delivery system 10 after the self-expanding stent 310 is released can be easily collected.

As shown in FIG. 2, the proximal end side of the inner tube 110 is formed obliquely so as to incline toward the proximal end side, and is provided so as to communicate with a guide wire outlet hole 122a of the outer tube 120 described later. . This facilitates guide wire guidance.

As the material for forming the inner tube 110, it is preferable to use a flexible material. For example, polyolefins such as polyethylene and polypropylene, polyamides, polyamide elastomers, polyesters such as polyethylene terephthalate, polyester elastomers, fluorine resins such as polytetrafluoroethylene (PTFE), PEEK, polyimide, and the like can be used. Among the above resins, a resin having thermoplasticity can be particularly preferably used.

As the material for forming the tip member 130, it is preferable to use a material having flexibility. For example, synthetic resin elastomers such as olefin elastomer, polyamide elastomer, styrene elastomer, polyurethane, urethane elastomer, fluororesin elastomer, synthetic rubber such as urethane rubber, silicone rubber, butadiene rubber, natural rubber such as latex rubber, etc. Rubbers can be used.

As shown in FIGS. 1 and 2, the outer tube 120 is disposed on the distal end side, and is disposed on the proximal side of the first outer tube 121 that houses the self-expanding stent 310 and the first outer tube 121. And a second outer tube 122.

The first outer tube 121 constitutes an accommodating portion 121a that can be accommodated in a state where the self-expandable stent 310 is compressed radially inward between the first outer tube 121 and the inner tube 110.

The accommodating portion 121a is formed by a portion surrounded by the distal end side movement restricting portion 111, the first fixing portion 220, and the first outer tube 121. The self-expanding stent 310 is exposed from the shaft portion 100 by being moved to the proximal end side with respect to the inner tube 110 by moving the first outer tube 121 to the stenosis portion in the living body lumen. At this time, the self-expanding stent 310 is subjected to a frictional force to move to the proximal end side with the movement of the first outer tube 121. However, the movement of the self-expanding stent 310 to the proximal end side is restricted by contacting the first fixing portion 220. Thus, the self-expanding stent 310 can be released without moving from the place where the stenosis is disposed.

A second fixing portion 230 described later is fixed to the inner surface of the first outer tube 121. The second fixing portion 230 is formed in an annular shape around the longitudinal axis.

As shown in FIG. 2, the second outer tube 122 has an outer diameter smaller than the inner diameter of the first outer tube 121, and is slidably inserted into the first outer tube 121. Thereby, the operation of moving the first outer tube 121 relative to the inner tube 110 can be facilitated.

As shown in FIG. 2, the second outer tube 122 has a guide wire lead-out hole 122 a that protrudes obliquely outward in the radial direction at the proximal end portion of the second outer tube 122. The guide wire lead-out hole 122a is provided so as to be able to communicate with the guide wire lumen 110a of the inner tube 110, and the guide wire can be led out of the outer tube 120. An insertion tube 520 (described later) is fixed in the lumen of the proximal end portion of the second outer tube 122.

As shown in FIG. 2, the moving unit 200 is disposed between the inner tube 110 and the outer tube 120 and closer to the proximal end side than the housing unit 121a. The moving unit 200 includes a balloon 210 that expands and contracts in the axial direction, a first fixing unit 220 (corresponding to the tip of the moving unit) fixed to the inner tube 110, and a second fixed to the outer tube 120. A fixed portion 230 (corresponding to a base end portion of the moving portion).

The balloon 210 is expanded and deformed when a pressurized medium such as physiological saline or a contrast medium is supplied to the inside. The pressurized medium is supplied into the balloon 210 via the tube member 510. The structure of the balloon 210 is not particularly limited, but is preferably a structure that is easily extended in the axial direction. In the present embodiment, as shown in FIG. 2, the balloon 210 is configured by a bellows structure, and is folded and contracted before expansion and is expanded in the axial direction after expansion. When the balloon 210 extends along the axial direction, the outer tube 120 is moved relative to the inner tube 110 along the axial direction. By using the balloon 210, the moving part 200 can be easily expanded and contracted.

The material for forming the balloon 210 is not particularly limited, but examples thereof include polyethylene, polypropylene, polyolefins of ethylene-propylene copolymer, polyesters such as polyethylene terephthalate, fluorine resins such as polytetrafluoroethylene (PTFE), polyvinyl chloride, and the like. Further, ethylene-vinyl acetate copolymer, cross-linked ethylene-vinyl acetate copolymer, thermoplastic resin such as polyurethane, polyamide elastomer, polystyrene elastomer, silicone rubber, latex rubber and the like can be used. Among the above, PTFE can be preferably used. As a result, the sliding resistance between the first outer tube 121 and the balloon 210 can be lowered and the balloon 210 can be easily deformed. It is also possible to coat a material having biocompatibility, in particular antithrombotic properties. As the antithrombogenic material, for example, dimethylacrylamide polymer can be used.

Further, as shown in FIG. 3A, the length L1 in the axial direction of the balloon 210 in a folded state can be formed to be, for example, 5 mm or less. As shown in FIG. 3B, the length L2 in the axial direction of the balloon 210 in the expanded state is, for example, 10 to 250 mm, and the diameter d is, for example, 1.0 to 1.8 mm. it can. In the expanded state, the distance L3 between the portion having the maximum outer diameter of the balloon 210 and the lumen of the first outer tube 121 is preferably 0.1 mm or more, for example.

The first fixing portion 220 is fixed to the inner tube 110 and is disposed on the proximal end side of the accommodating portion 121a that accommodates the stent 300. The second fixing portion 230 is fixed to the proximal end of the balloon 210. The means for fixing the first fixing portion 220 to the inner tube 110 and the means for fixing the second fixing portion 230 to the outer tube 120 are not particularly limited, but for example, fixing means such as fusion or adhesive may be used. it can. The first fixing portion 220 and the second fixing portion 230 are configured to be able to move apart as the balloon 210 is expanded and deformed. In addition, a tube member 510 for supplying a pressurized medium is inserted between the second fixing portion 230 and the inner tube 110. However, since the pressurized medium does not leak from the balloon 210, the tube member 510 is liquid-tight and air-tight. The inner tube 110 has a slidable structure, and in this embodiment, the packing 800 is provided between the second fixing portion 230 and the inner tube 110. However, the present invention is not limited to this, and any structure may be used as long as the pressurized medium does not leak from the inside of the balloon 210 and is liquid-tight / air-tight and the inner tube 110 is slidable.

As the forming material of the first fixing part 220 and the second fixing part 230, it is preferable to use a material having high rigidity. For example, a metal such as stainless steel or a resin can be used.

In addition, although the 1st fixing | fixed part 220 and the 2nd fixing | fixed part 230 were fixed to the balloon 210, it is not limited to this, The balloon 210 is not fixed, but the 1st fixing | fixed part 220 and 2nd You may arrange | position between the fixed parts 230. In this case, the first fixing part 220 and the second fixing part 230 may be in close contact with the balloon 210 so that there is no gap, or a gap may be provided.

The self-expanding stent 310 is accommodated in the accommodating portion 121a in a state of being compressed inward in the radial direction around the longitudinal axis of the outer tube 120 when inserted into the living body lumen. As the outer tube 120 moves toward the proximal end, the accommodating portion 121a is exposed to the outside, and the self-expanding stent 310 is released to the stenosis portion in the living body lumen. This expands radially outward and restores the shape before compression. The stent 300 is formed in a substantially cylindrical shape with a mesh shape having a large number of openings. As a material constituting the stent 300, for example, a superelastic alloy such as a Ni—Ti alloy can be preferably used.

Referring to FIG. 1 again, the hub 400 is arranged on the proximal end side (hand side), and operates the expansion / contraction deformation of the moving unit 200. The hub 400 includes a supply device (not shown) for supplying and discharging the pressurized medium, and a connection portion 410 that can be connected in a liquid-tight and air-tight manner. The connection unit 410 can be configured by, for example, a luer taper configured such that a tube connected to the supply device can be connected and separated.

The supply device supplies a pressurized medium into the balloon 210 to expand the balloon 210 into a predetermined shape. As the supply device, for example, a known indeflator or the like can be used.

The pressurized medium used for the expansion of the balloon 210 can flow into the shaft portion 100 via the connection portion 410 of the hub 400. The pressurized medium is supplied to the balloon 210 via the tube member 510.

The tube member 510 is arranged in parallel so as to follow the outer surface of the inner tube 110, and is configured by a long tubular body in which a lumen that passes through the pressurized medium through the tip end to the base end is formed. . The tube member 510 transfers the pressurized medium and supplies it to the balloon 210 or discharges it from the balloon 210. The proximal end of the balloon 210 is joined to the distal end of the tube member 510 in a liquid-tight or air-tight manner by welding or the like. Although the tube member 510 is provided on the outer surface side of the inner tube 110, the present invention is not limited to this. For example, the inner tube 110 may be inserted into the tube member 510. In this case, the inner tube 110 and the tube member 510 are configured by a double tube structure concentrically aligned, and a lumen for supplying a pressurized medium may be formed between the inner tube 110 and the tube member 510. Good.

The insertion tube 520 is constituted by a long tubular body extending from the proximal end portion of the balloon 210 to the hub 400, and the tube member 510 is inserted therethrough.

Examples of the material for forming the tube member 510 and the insertion tube 520 include polyethylene, polypropylene, polyolefins such as ethylene-propylene copolymer and ethylene-vinyl acetate copolymer, thermoplastic resins such as soft polyvinyl chloride, silicone rubber, Various rubbers such as latex rubber, various elastomers such as polyurethane elastomer, polyamide elastomer, and polyester elastomer, and crystalline plastics such as polyamide, crystalline polyethylene, and crystalline polypropylene can be used. In these materials, for example, an antithrombotic substance such as heparin, prostaglandin, urokinase, arginine derivative or the like can be blended to obtain a material having antithrombotic properties.

Hereinafter, a method of placing the self-expanding stent 310 in the stenosis portion by the stent delivery system 10 of the first embodiment will be described.

First, a guide wire is inserted into the opening 110b of the tip member 130 shown in FIGS. 1 and 2, and a guide wire (not shown) is led out from the guide wire lead-out hole 122a. Next, the shaft portion 100 is inserted into the living body and pushed along the guide wire, and the accommodating portion 121a of the first outer tube 121 is disposed in the narrowed portion. At this time, as shown in FIG. 3A, the balloon 210 is in a contracted state before being expanded (expanded). In addition, the self-expanding stent 310 is disposed in advance in the accommodating portion 121a in a contracted state.

Next, the pressurized medium is supplied to the balloon 210 from the supply device. As a result, as shown in FIG. 3B, the balloon 210 is expanded and deformed in the axial direction, and the first fixing portion 220 located on the distal end side is moved to the distal end side, and the second fixing portion located on the proximal end side. 230 move away from each other toward the base end side. Due to this separation movement, the moving part 200 expands and moves the outer pipe 120 to which the second fixing part 230 is fixed relative to the inner pipe 110 to which the first fixing part 220 is fixed. The self-expandable stent 310 is exposed from the shaft portion 100 by moving the inner tube 110 and the outer tube 120 relative to each other along the axial direction.

The self-expanding stent 310 is disposed closer to the distal end side of the shaft portion 100 than the first fixing portion 220 in a state before the moving portion 200 is extended (see FIG. 3A). For this reason, when the stent 310 is exposed, the distance for moving the outer tube 120 with respect to the inner tube 110 can be shortened, so that the self-expanding stent 310 can be released to the stenosis more quickly. It becomes possible.

As in the stent delivery system 10 according to this embodiment, the stent delivery system 10 ′ according to the comparative example shown in FIG. 4 includes an inner tube 110 ′ and an outer tube disposed around the inner tube 110 ′. A tube 120 ′. The self-expandable stent 310 is delivered to the living body lumen in a state where the self-expandable stent 310 is accommodated on the distal end side of the shaft portion 100 ′, and the outer tube 120 ′ is moved relative to the inner tube 110 ′. Is placed in the body lumen. The stent delivery system 10 ′ according to the comparative example is a wire pulling type in which the pulling

wires

700a and 700b fixed to the outer tube 120 are pulled to the proximal side by a hand operation to move the outer tube 120 ′ to the proximal side. This embodiment is different from the present embodiment in that it has a moving mechanism.

FIG. 4 (A) shows the distal end portion of the stent delivery system 10 'before towing. In this state, it is inserted into the living body lumen from the distal end side.

Next, as shown in FIG. 4B, when the distal end portion is inserted into the constricted portion, the distal end portion of the shaft portion 100 ′ is radially inward by the constricted portion (the arrow direction in FIG. 4B). A load (restraint force) may be applied. When the inner diameter of the constricted portion is extremely narrow, a load inward in the radial direction is increased, and the accommodating portion 121a that accommodates the self-expanding stent 310 is compressed. At this time, the static frictional resistance between the self-expandable stent 310 and the outer tube 120 ′ in the accommodating portion 121 a is increased by a restoring force that the self-expandable stent 310 tries to spread radially outward. In particular, when the pulling

wires

700a and 700b are pulled at a relatively long distance, the pulling force acting along with the pulling is also increased, so that the static frictional resistance is further increased.

Also, when the outer tube 120 ′ is pulled toward the proximal end, the self-expanding stent 310 moves toward the proximal end due to static frictional resistance. Accordingly, the first fixing portion 220 ′ fixed to the inner tube 110 ′ on the proximal end side of the self-expandable stent 310 is moved by the self-expandable stent 310 in the proximal direction by being pressed by the self-expandable stent 310. It takes. Therefore, since the first fixing portion 220 ′ applies a force in the direction of moving the inner tube 110 toward the proximal end, the proximal end of the inner tube 110 ′ may be bent.

At this time, as shown in FIG. 4C, when the shaft portion 100 ′ is moved toward the proximal end in order to remove the distal end side portion, it is released from the restraining force by the narrowed portion, so that the outer tube 120 ′ The axial static frictional resistance with the self-expanding stent 310 is reduced. The inner tube 110 ′ attempts to push the first fixing portion 220 ′ toward the distal end side and to push the self-expanding stent 310 toward the distal end side of the outer tube 120 ′ by a restoring force to restore the deflection. To generate a driving force.

As shown in FIG. 4D, the propulsive force causes the self-expandable stent 310 to jump over the stenosis portion to be treated and jump to an unintended place or the length of the self-expandable stent 310. This may cause a so-called shortening phenomenon in which the length becomes shorter than the target length.

In the stent delivery system 10 according to the present embodiment, when the self-expanding stent 310 is placed, the outer tube 120 is moved with respect to the inner tube 110 by the expansion / contraction deformation of the moving unit 200 disposed in the shaft unit 100 as described above. It can be moved relatively. For this reason, regardless of the distance from the operation unit (such as the hub 400) disposed outside the living body to the treatment target site, the distance between the moving unit 200 serving as a power source and the outer tube 120 serving as the moving target can be kept short. it can. Therefore, since the force for moving the outer tube 120 with respect to the inner tube 110 is easily transmitted, it is possible to more reliably and easily expose the self-expanding stent 310 from the shaft portion 100 to perform the treatment of the stenosis. it can.

Also, when the balloon 210 is expanded and deformed, the first fixing portion 220 moves away from the distal end side, and the second fixing portion 230 moves away from the proximal end side. Since the 1st fixing | fixed part 220 is being fixed to the inner tube | pipe 110, force is applied to the direction where the inner tube | pipe 110 moves to the front end side. For this reason, it can suppress that the inner pipe | tube 110 moves to a base end side, and bends. Thereby, when the self-expanding stent 310 is placed, a so-called jumping phenomenon or shortening phenomenon can be prevented.

As described above, the stent delivery system 10 according to the first embodiment includes the inner tube 110 and the outer tube 120 disposed so as to cover the outer peripheral surface of the inner tube 110, and is inserted into a living body lumen. The shaft portion 100 is disposed between the inner tube 110 and the outer tube 120, and the outer tube 120 is extended with respect to the inner tube 110 along the axial direction by expanding and contracting along the axial direction of the shaft portion 100. The moving part 200 to be moved relatively and before the moving part 200 expands and contracts are accommodated between the inner tube 110 and the outer tube 120, and are exposed from the shaft part 100 when the moving part 200 expands and contracts and the living body A self-expandable stent 310 that performs a predetermined treatment on a treatment target site in the lumen.

According to the stent delivery system 10 configured as described above, the outer tube 120 can be moved relative to the inner tube 110 by the expansion and contraction of the moving unit 200 disposed in the shaft unit 100. For this reason, force can be easily transmitted to the outer tube 120, and the self-expandable stent 310 can be more reliably and easily exposed from the shaft portion 100 to perform the treatment of the stenosis.

Further, the first fixing part 220 is fixed to the inner pipe 110, and the second fixing part 230 is fixed to the outer pipe 120. When the moving part 200 is extended, the inner pipe 110 and the outer pipe 120 are The self-expanding stent 310 is exposed from the shaft portion 100 by moving forward and backward with respect to each other along the axial direction.

According to the stent delivery system 10 configured as described above, since the force is applied in the direction in which the inner tube 110 moves toward the distal end side, the inner tube 110 can be prevented from being bent. As a result, it is possible to prevent a so-called jumping phenomenon or shortening phenomenon from occurring when a treatment portion such as the self-expanding stent 310 is placed.

In addition, the self-expanding stent 310 is disposed on the distal end side of the shaft portion 100 with respect to the first fixing portion 220 in a state before the moving portion 200 extends.

According to the stent delivery system 10 configured as described above, since the relative moving distance of the outer tube 120 with respect to the inner tube 110 can be shortened, the self-expandable stent 310 is treated more quickly in the stenosis. be able to.

The outer tube 120 includes a first outer tube 121 to which the moving unit 200 is fixed, and a second outer tube 122 that is slidably inserted into the first outer tube 121.

According to the stent delivery system 10 configured as described above, the operation of moving the first outer tube 121 relative to the inner tube 110 can be facilitated.

Further, the moving unit 200 is configured by a balloon 210 that expands and contracts in the axial direction by inflow and discharge of the pressurized medium.

According to the stent delivery system 10 configured in this way, the moving part 200 can be easily expanded and contracted.

In addition, the treatment unit is accommodated in a state compressed inward in the radial direction of the shaft before the moving unit 200 expands, and a living body that is a living organ after the moving unit 200 expands and is exposed from the shaft unit 100. It includes a self-expanding stent 310 that is placed in the lumen.

According to the stent delivery system 10 configured as described above, the self-expandable stent 310 can be smoothly placed in the stenosis.

(Modification of the first embodiment)
FIG. 5 is a cross-sectional view of a stent delivery system 10a according to a modification of the first embodiment. FIG. 5 (A) shows a state before the moving part 200 is stretched and deformed, and FIG. The state after the moving part 200 expands and contracts is shown. Hereinafter, a stent delivery system 10a according to a modification of the first embodiment will be described with reference to FIG.

The stent delivery system 10a according to the modified example of the first embodiment is different from the first embodiment only in the configuration of the moving part 200, and the self-expandable stent 310 is exposed from the shaft part 100 by contracting and deforming the moving part 200. This is different from the first embodiment. Other configurations are the same as those of the first embodiment. Hereinafter, description of the same configuration as that of the first embodiment will be omitted. In addition, about the member which has the structure similar to 1st Embodiment, it demonstrates using the same code | symbol.

As shown in FIG. 5A, the moving unit 200 is disposed between the inner tube 110 and the outer tube 120 on the proximal side from the housing unit 121a, as in the first embodiment. The moving unit 200 includes a balloon 210 that is contracted and deformed in the axial direction, a first fixing unit 220 that is fixed to the outer tube 120, and a second fixing unit 230 that is fixed to the inner tube 110.

The balloon 210 is contracted and deformed when the pressurized medium is discharged from a state where the pressurized medium such as physiological saline or contrast medium is filled inside. The structure and forming material of the balloon 210 are the same as those in the first embodiment.

The first fixing part 220 is fixed to the tip of the balloon 210. The second fixing portion 230 is fixed to the inner tube 110 and is disposed on the proximal end side of the accommodating portion 121 a that accommodates the self-expanding stent 310. The fixing means of the first fixing part 220 and the second fixing part 230 is the same as in the first embodiment. Note that the present invention is not limited to fixing, and any structure may be used as long as the first fixing unit 220 and the second fixing unit 230 can be moved by following deformation of the balloon 210 by engagement or the like. The first fixing portion 220 and the second fixing portion 230 are configured to be able to move closer together with the contraction deformation of the balloon 210. Other configurations and forming materials of the first fixing portion 220 and the second fixing portion 230 are the same as those in the first embodiment.

Hereinafter, a method of placing the self-expanding stent 310 in the stenosis portion by the stent delivery system 10a of the present embodiment will be described.

First, similarly to the first embodiment, the accommodating portion 121a of the self-expandable stent 310 of the first outer tube 121 is disposed in the narrowed portion. At this time, as shown in FIG. 5A, the balloon 210 is in an expanded state with the inside filled with a pressurized medium. In addition, the self-expanding stent 310 is disposed in advance in the accommodating portion 121a in a contracted state.

Next, the pressurized medium is discharged from the balloon 210 by the supply device. As a result, as shown in FIG. 5B, the balloon 210 is contracted and deformed in the axial direction, and the first fixing portion 220 located on the distal end side is moved to the proximal end side, and the second fixed portion located on the proximal end side. The parts 230 move toward each other toward the tip side. By this approaching movement, the moving part 200 contracts, and the outer tube 120 to which the first fixing part 220 is fixed is moved relative to the inner pipe 110 to which the second fixing part 230 is fixed. As the inner tube 110 and the outer tube 120 move closer to each other along the axial direction, the self-expanding stent 310 is exposed from the shaft portion 100 and is placed in the stenosis portion.

As described above, the stent delivery system 10b according to the modification of the first embodiment obtains the same effect by the same configuration as that of the first embodiment. Moreover, the following effects are further exhibited by the following configuration characteristic of the modification of the first embodiment.

In the stent delivery system 10a according to the modification of the first embodiment, the first fixing portion 220 is fixed to the outer tube 120, and the proximal end portion of the moving portion 200 is fixed to the inner tube 110. When the inner tube 110 and the outer tube 120 move closer to each other along the axial direction when the tube 200 contracts, the self-expanding stent 310 is exposed from the shaft portion 100.

According to the stent delivery system 10a configured as described above, when the self-expandable stent 310 is released, the shaft portion 100 is contracted and reduced in size, so that the shaft portion 100 is removed from the living body in a reduced size. Is possible.

(Second Embodiment)
FIG. 6 is a cross-sectional view of the stent delivery system 10b according to the second embodiment. FIG. 6 (A) shows a state before the moving part 200 expands and contracts, and FIG. 6 (B) shows the moving part 200. FIG. 6C shows a state where the portion 210a exposed from the shaft portion 100 of the moving unit 200 is further stretched and deformed. Hereinafter, the stent delivery system 10b according to the second embodiment will be described with reference to FIG.

The stent delivery system 10b according to the second embodiment is different from the first embodiment in that when the moving part 200 extends, a part of the moving part 200 is exposed from the shaft part 100 and further expands and deforms in the radial direction. . Hereinafter, description of the same configuration as that of the first embodiment will be omitted. In addition, about the member which has the structure similar to 1st Embodiment, it demonstrates using the same code | symbol.

An example in which a balloon expandable stent 320 is used as the stent 300 will be described. However, the stent 300 used in this embodiment is not limited to the balloon expandable stent 320, and a self-expandable stent 310 may be used.

The balloon 210 is expandable in the axial direction and the radial direction. The structure of the balloon 210 is the same as that of the first embodiment. The material for forming the balloon 210 can be the same as that of the first embodiment, but it is preferable to form the balloon 210 with a configuration having different material properties on the distal end side and the proximal end side. For example, it is possible to use a material in which the forming material on the distal end side has higher elastic compliance than the proximal end side. As a result, the portion exposed from the shaft portion 100 on the distal end side of the balloon 210 is more easily deformed radially outward. Note that the balloon 210 may be formed of the same material. In this case, the balloon expandable stent 320 is disposed on the outer surface side of the balloon 210 in a state before the moving part 200 is extended. Thereby, the balloon expandable stent 320 can be easily expanded radially outward as the balloon 210 is expanded in the radial direction.

Hereinafter, a method for placing the balloon-expandable stent 320 in the stenosis portion by the stent delivery system 10b of the present embodiment will be described.

First, similarly to the first embodiment, the accommodating portion 121a of the balloon expandable stent 320 of the first outer tube 121 is disposed in the narrowed portion. At this time, as shown in FIG. 6A, the balloon 210 is in a contracted state before being expanded (expanded). Further, the balloon expandable stent 320 is arranged in advance in the accommodating portion 121a.

Next, as shown in FIG. 6B, as in the first embodiment, a pressurized medium is supplied to the balloon 210 to expand and deform the balloon 210 in the axial direction. As a result, the moving unit 200 extends to move the outer tube 120 to which the second fixing unit 230 is fixed relative to the inner tube 110 to which the first fixing unit 220 is fixed. The balloon expandable stent 320 is exposed from the shaft portion 100 by the inner tube 110 and the outer tube 120 moving back and forth in the axial direction. The balloon 210 has a portion 210a that is exposed from the shaft portion 100 when the inner tube 110 and the outer tube 120 move forward and backward. By expanding the balloon 210 so as to be exposed from the shaft portion 100, the expansion force of the balloon 210 is increased. Therefore, it is possible to increase the propulsive force that moves the outer tube 120 of the moving unit 200 toward the proximal side with respect to the inner tube 110.

Thereafter, as shown in FIG. 6C, the pressurized medium is further supplied to the balloon 210 to expand and deform the balloon 210 radially outward. As a result, after the balloon expandable stent 320 is indwelled, it can be expanded radially outward.

As described above, the stent delivery system 10b according to the second embodiment obtains the same effect by the same configuration as that of the first embodiment. In addition, the following effects, which are characteristic of the second embodiment, further exhibit the following effects.

A part of the moving part 200 of the stent delivery system 10b according to the second embodiment is exposed from the shaft part 100 when extended.

According to the stent delivery system 10b configured as described above, it is possible to increase the driving force for moving the outer tube 120 of the moving unit 200 to the proximal side with respect to the inner tube 110.

Further, the portion 210 a exposed from the shaft portion 100 in the moving portion 200 is configured to be expandable and deformable outward in the radial direction of the shaft portion 100.

According to the stent delivery system 10b configured as described above, after the balloon expandable stent 320 is exposed from the shaft portion 100, the balloon expandable stent 320 can be further expanded radially outward. In particular, the balloon expandable stent 320 is preferably used. be able to.

Further, the balloon expandable stent 320 is disposed on the outer surface side of the balloon 210 in a state before the moving part 200 is extended.

According to the stent delivery system 10b configured in this manner, the first fixing portion 220 can be disposed on the outer surface side of the balloon 210 that expands radially outward, and thus the balloon expandable stent 320 can be easily aligned in the radial direction. Can be expanded outward.

Further, the treatment unit is accommodated in a state compressed inward in the radial direction of the shaft before the moving unit 200 is extended, and is inserted into the living body lumen after the moving unit 200 is extended and exposed from the shaft unit 100. It includes a balloon expandable stent 320 that is deployed.

According to the stent delivery system 10 configured as described above, the balloon expandable stent 320 can be smoothly placed in the stenosis and further expanded radially outward.

(Third embodiment)
FIG. 7 shows a stent delivery system 10c according to the third embodiment. FIG. 7 (A) shows a state before the moving part 200 is stretched and deformed, and FIG. 7 (B) shows that the moving part 200 is stretched and deformed. The state after doing. Hereinafter, the stent delivery system 10c according to the third embodiment will be described with reference to FIG.

The stent delivery system 10c according to the third embodiment is the first in that it has a limiting unit 240 that limits the amount of movement of the outer tube 120 relative to the inner tube 110 when the moving unit 200 extends. Different from the embodiment. Hereinafter, description of the same configuration as that of the first embodiment will be omitted. In addition, about the member which has the structure similar to 1st Embodiment, it demonstrates using the same code | symbol.

As shown in FIG. 7A, the restricting portion 240 has a locking member 241 fixed to the inner tube 110 on the proximal end side of the moving portion 200. The locking member 241 abuts on the first fixing portion 220 and restricts the movement toward the proximal end side with respect to the inner tube 110. The locking member 241 can use the same material as the first fixing portion 220 and the second fixing portion 230.

Hereinafter, a method of placing the self-expanding stent 310 in the stenosis portion by the stent delivery system 10c of the present embodiment will be described.

First, similarly to the first embodiment, the accommodating portion 121a of the self-expandable stent 310 of the first outer tube 121 is disposed in the narrowed portion. At this time, as shown in FIG. 7A, the balloon 210 is in a contracted state before being expanded (expanded). In addition, the self-expanding stent 310 is disposed in advance in the accommodating portion 121a in a contracted state.

Next, as in the first embodiment, a pressurized medium is supplied to the balloon 210 to expand and deform the balloon 210 in the axial direction. As a result, the moving unit 200 extends to move the outer tube 120 to which the second fixing unit 230 is fixed relative to the inner tube 110 to which the first fixing unit 220 is fixed. As the inner tube 110 and the outer tube 120 move back and forth in the axial direction, the self-expanding stent 310 is exposed from the shaft portion 100 and is placed in the stenosis. At this time, as shown in FIG. 7B, when the balloon 210 is expanded by an amount sufficient to expose the self-expanding stent 310, the first fixing portion 220 comes into contact with the locking member 241 and is expanded. The expansion deformation is suppressed and the movement of the outer tube 120 is limited. As a result, overexpansion of the balloon 210 can be prevented, and the amount of movement of the outer tube 120 can be limited regardless of the physical properties of the balloon 210.

As described above, the stent delivery system 10c according to the third embodiment obtains the same effect by the same configuration as that of the first embodiment. In addition, the following effects that are characteristic of the third embodiment further exhibit the following effects.

The stent delivery system 10c according to the third embodiment further includes a limiting unit 240 that limits the amount of movement of the outer tube 120 relative to the inner tube 110 when the moving unit 200 extends.

According to the stent delivery system 10c configured as described above, the movement amount of the outer tube 120 can be limited regardless of the physical properties of the balloon 210.

Further, since the restricting portion 240 is configured by the locking member 241, it is possible to easily adjust the amount of movement of the outer tube 120 relative to the inner tube 110 by changing the position of the locking member 241. it can.

(Modification of the third embodiment)
FIG. 8 is a cross-sectional view of a stent delivery system 10d according to a modification of the third embodiment. FIG. 8 (A) shows a state before the moving part 200 is stretched and deformed, and FIG. The state after the moving part 200 expands and contracts is shown. Hereinafter, a stent delivery system 10d according to a modification of the third embodiment will be described with reference to FIG.

The stent delivery system 10d according to the third embodiment is different from the third embodiment in that the limiting portion 640 is configured by the reduced diameter portion 623 of the outer tube 620. Hereinafter, description of the same configurations as those of the first embodiment and the third embodiment will be omitted. In addition, about the member which has the structure similar to 1st Embodiment and 3rd Embodiment, it demonstrates using the same code | symbol.

As shown in FIG. 8A, the restricting portion 240 is constituted by a reduced diameter portion 623 of the outer tube 120. The reduced diameter portion 623 includes a first reduced diameter portion 623 a formed in the first outer tube 621 and a second reduced diameter portion 623 b formed in the second outer tube 622.

As in the first and third embodiments, the outer tube 620 includes a first outer tube 621 disposed on the distal end side and a second outer tube disposed on the proximal end side of the first outer tube 621. A tube 622. In the first embodiment, the second outer tube 622 is slidably inserted into the first outer tube 621. However, in the modification of the third embodiment, the first outer tube 621 is the first outer tube 621. 2 slidably inserted into the outer tube 622.

The first reduced diameter portion 623a is formed at the proximal end portion of the first outer tube 621 and gradually decreases in diameter toward the proximal end. The second reduced diameter portion 623b is formed at a position on the base end side of the predetermined length from the distal end of the second outer tube 622, and gradually decreases in diameter toward the distal end in the same manner as the first reduced diameter portion 623a. When the first outer tube 621 moves to the proximal end side for a predetermined length, the first reduced diameter portion 623a contacts the second reduced diameter portion 623b. As a result, the amount of movement of the outer tube 620 can be limited, and overexpansion of the balloon 210 can be prevented. Moreover, since the restriction part 640 is configured by the reduced diameter part 623, the expansion of the balloon 210 can be gradually suppressed, so that the burden on the balloon 210 can be reduced as compared with the case where the expansion is suddenly stopped.

The method for placing the self-expanding stent 310 in the stenosis portion by the stent delivery system 10d of the present embodiment is the same as that of the third embodiment, and thus the description thereof is omitted.

As described above, the stent delivery system 10d according to the third embodiment obtains the same effect by the same configuration as the first embodiment and the third embodiment. In addition, the following effects that are characteristic of the third embodiment further exhibit the following effects.

The stent delivery system 10d according to the modification of the third embodiment obtains the same effect by the same configuration as that of the third embodiment. Moreover, there exists an advantageous effect by the following structures characteristic to the modification of 3rd Embodiment.

In the stent delivery system 10d according to the modification of the third embodiment, the restricting portion 240 is configured by the reduced diameter portion 623 of the outer tube 620. Thereby, since the expansion of the balloon 210 can be gradually suppressed, the burden on the balloon 210 can be reduced as compared with the case where the expansion is suddenly stopped.

As mentioned above, although the stent delivery system 10 which concerns on this invention was demonstrated through embodiment and the some modification, this invention is not limited only to the structure demonstrated in embodiment and each modification, Changes can be made as appropriate based on the description.

For example, although the stent delivery system 10 in which the stent 300 is placed in the living body lumen has been described, the treatment unit and the medical device are not limited thereto. For example, a medical device configured to use an elution balloon that elutes a drug in a living organ as a treatment portion and deliver the treatment portion to a desired position in the living body lumen. In this case, the moving unit can be used as a treatment unit. Furthermore, as in the second embodiment described above, the moving part is configured to be partly exposed from the shaft part and expandable in the radial direction (see FIGS. 6B and 6C). Further, the outer surface of the exposed part is coated with at least a drug that functions as a treatment part. By configuring in this way, the exposed and expanded part can come into contact with the lesion site and the drug can be eluted and permeated through the treatment part.

In addition, although the moving unit 200 is configured by the balloon 210, the moving unit 200 is not limited thereto, and may be configured by a material that can be expanded and contracted such as a spring.

This application is based on Japanese Patent Application No. 2015-048756 filed on Mar. 11, 2015, the disclosure of which is incorporated by reference in its entirety.

10, 10 ′, 10a, 10b, 10c, 10d stent delivery system (medical device),
100, 100 'shaft part,
110, 610 inner tube,
111 tip side movement restriction part,
120, 120 ′, 620, outer tube,
121, 621 first outer tube,
122, 622 second outer tube,
200 moving part,
210 balloon,
220, 220 ′ first fixed part (tip part of moving part),
230 second fixed part (base end part of the moving part),
240, 640 restriction part,
241 locking member,
300 stent (treatment area),
400 hubs,
410 connection,
510 tube member,
520 intubation tube,
623 reduced diameter part,
700a, 700b puller wire,
800 packing.

Claims

An inner tube and an outer tube disposed so as to cover the outer peripheral surface of the inner tube, and a shaft portion inserted into a living organ;
The outer tube is disposed between the inner tube and the outer tube, and is expanded and contracted along the axial direction of the shaft portion, thereby moving the outer tube relative to the inner tube along the axial direction. A moving part;
Before the moving part is stretched and deformed, it is accommodated between the inner tube and the outer tube, and when the moving part is stretched and deformed, the moving part is exposed from the shaft part and is against the treatment target site in the living organ. A medical device having a treatment unit for performing a predetermined treatment.
The tip of the moving part is fixed to the inner tube,
The base end of the moving part is fixed to the outer tube,
The medical device according to claim 1, wherein the treatment section is exposed from the shaft portion by the inner tube and the outer tube moving forward and backward along the axial direction when the moving portion extends.
The medical device according to claim 2, wherein at least a part of the moving part is exposed from the shaft part when extended.
The medical device according to claim 3, wherein a portion exposed from the shaft portion in the moving portion is configured to be expandable and deformable outward in the radial direction of the shaft portion.
5. The treatment section according to claim 3, wherein the treatment section is disposed closer to a distal end side of the shaft section or an outer surface side of the moving section than a distal end section of the moving section in a state before the moving section extends. The medical device described.
The medical device according to any one of claims 2 to 5, further comprising a limiting unit that limits a moving amount of the outer tube relative to the inner tube when the moving unit is extended. .
The outer tube includes a first outer tube to which the moving portion is fixed, and a second outer tube that is slidably inserted into the first outer tube. The medical device according to claim 1.
The medical device according to any one of claims 1 to 7, wherein the moving unit is configured by a balloon that is elastically deformed in the axial direction by inflow and discharge of a pressurized medium.
The treatment portion is accommodated in a state compressed inward in the radial direction of the shaft portion before the moving portion is extended, and after the moving portion is extended and exposed from the shaft portion, The medical device according to any one of claims 1 to 8, comprising a stent placed in a living body lumen.