JP6859808B2 - Stent delivery system - Google Patents

Description

The present invention relates to a stent delivery system.

Conventionally, in a stenotic disease (tumor, inflammation, etc.) of a biological duct such as a blood vessel or a gastrointestinal tract, a stent is placed in the stenotic part to dilate the stenotic part. As the stent, for example, a metal or resin stent is known. Further, in recent years, biodegradable stents that can reduce the burden on patients have been proposed because they are decomposed with the passage of time in blood vessels and gastrointestinal tracts.

Stents generally push the stenosis apart by bringing it closer to the stenosis in a reduced diameter state and then expanding the diameter. For example, as a method of bringing the stent closer to the stenosis, a method using an endoscope is known. In this method, a stent with a reduced diameter is housed in a thin tubular member called a delivery system, and the delivery system is inserted into the endoscope through a forceps opening to approach the stenosis (for example, Patent Document 1). reference).

Patent Document 1 discloses a stent delivery system including an outer cylinder in contact with the inner wall of a forceps channel of an endoscope and an inner cylinder inserted into the outer cylinder so as to be able to advance and retreat. Accurate positioning is required when placing the stent in the stenosis. In order to deploy the stent at an appropriate position, the stent loaded at the tip of the inner cylinder is pushed out from the outer cylinder, so the outer cylinder is pulled back to the hand side (base end side) with respect to the inner cylinder, and the inner cylinder is used. It is necessary for a plurality of doctors to perform the operation of pushing the cylinder into the outer cylinder in a timely manner.

Japanese Unexamined Patent Publication No. 2004-181230

When a stent is placed in a living body using a stent delivery system in this way, a very difficult operation is required.
Therefore, a stent delivery system that can place a stent at a desired position with a simple operation is desired.

An object of the present invention is to provide a stent delivery system capable of improving operability when a stent is placed in a constricted portion in a living body.

The present invention is a stent delivery system for indwelling a stent in a living body, the tubular member, a axial member arranged inside the tubular member so as to be able to advance and retreat in the axial direction, and the tubular member. And an operation mechanism for moving the shaft-shaped member in the opposite direction in the axial direction, and the operation mechanism reverses the direction of the power for moving the tubular member or the shaft-shaped member in the axial direction. The present invention relates to a stent delivery system having a direction changing unit capable of converting in a direction and a transmitting unit for transmitting power between the tubular member and the shaft-shaped member.

Further, it is preferable that the operation mechanism is further provided with an operation base provided on the base end side to support the direction changing portion.

Further, the direction changing portion is formed in a roller shape and is rotatably connected to the operation base, and the shaft-shaped member extends from the tubular member toward the base end side and is tipped by the direction changing portion. It is preferable that the direction is changed to the side and one end on the base end side is connected to the transmission portion.

Further, it is preferable that the transmission portion is composed of a transmission string having one end connected to the base end portion of the tubular member and the other end connected to the shaft-shaped member and hung over the direction changing portion.

Further, the operation mechanism further includes an operation base provided on the base end side to support the direction changing portion, and the tubular member is held by the operation base so that the base end portion can slide in the axial direction. Is preferable.

Further, the tubular member is an outer cylinder capable of accommodating the stent inside the distal end side, and further includes a pusher arranged on the distal end side of the axial member and capable of pushing the stent out of the outer cylinder. Is preferable.

Further, an outer cylinder capable of accommodating the stent is further provided inside the tip side, and the tubular member is arranged inside the outer cylinder so as to be able to advance and retreat in the axial direction, and the stent is moved from the outer cylinder at the tip portion. An extrudable inner cylinder, the stent is formed by braiding in a cylindrical shape with a fiber material, and has a stent main body that can be deformed from a reduced diameter state to an expanded state, and the tip side of the stent main body. A first engaging member provided at the end of the stent, a second engaging member provided at the distal end of the stent body and capable of engaging with the first engaging member, and the said. The stent body has a string-shaped member that connects the first engaging member and the shaft-shaped member, and the string-shaped member is pulled toward the proximal end side in a reduced diameter state. As a result, the diameter is expanded by contracting in the axial direction, the first engaging member and the second engaging member move in a direction close to each other, and the first engaging member and the second engaging member are engaged. It is preferable that the joint member is engaged and the diameter is maintained in an expanded state.

Further, the operation mechanism is further provided with an operation base provided on the base end side to support the direction changing portion, and the outer cylinder is held by the operation base so that the base end portion can slide in the axial direction. preferable.

Further, the first engaging member is an annular member formed of a fiber material, and the second engaging member is a locking portion formed of a fiber material and capable of locking the annular member. One end of the string-shaped member is connected to the locking portion, extends to the distal end side of the stent main body portion and is inserted into the annular member, and the other end extends to the proximal end side of the stent main body portion. It is preferably connected to a shaft-shaped member.

Further, the shaft-shaped member is preferably a guide wire guide tube into which a guide wire for guiding the stent delivery system to be inserted into the body is inserted.

Further, the stent main body portion has a diameter-expanded portion having a diameter larger than the diameter of the central portion in the expanded state at the end portion on the distal end side, and the diameter-expanded portion has the stent main body portion contracted. In the diameterd state, the string-shaped member is pulled to the base end side by a predetermined length to increase the diameter, and one end side of the transmission portion is connected to the shaft-shaped member and is hung on the direction changing portion. A transmission string and a reel portion fixed to the base end portion of the inner cylinder are provided, and the reel portion is for winding to which the other end side of the transmission string is connected so that the transmission string can be wound up. It is preferable to have a gear.

Further, the present invention is a stent delivery system for indwelling a stent in a living body, and the stent is formed by braiding in a cylindrical shape with a fiber material, and is deformed from a reduced diameter state to an expanded state. A possible stent body, a first engaging member provided at the distal end of the stent body, and a first engaging member provided at the proximal end of the stent body. It has a second engaging member capable of engaging with the first engaging member, and a string-shaped member whose tip end side is connected to the first engaging member, and the stent main body portion has the string in a reduced diameter state. By pulling the shaped member toward the proximal end side, the shape member contracts in the axial direction and the diameter is expanded, and the first engaging member and the second engaging member move in a direction close to each other and the second engaging member. The engaging member of 1 and the second engaging member are engaged and maintained in an enlarged diameter state, and the stent delivery system is
An outer cylinder that can store the stent inside the tip side, an inner cylinder that is arranged inside the outer cylinder so as to be able to advance and retreat in the axial direction and that can push the stent out of the outer cylinder at the tip portion, and the inner cylinder. A shaft-shaped member that is arranged inside the inner cylinder so as to be able to move forward and backward in the axial direction, and a string-shaped member that is arranged inside the inner cylinder so that the inner cylinder can move forward and backward in the axial direction. The inner cylinder is provided with an operation mechanism for moving the rod-shaped member to the proximal end side, and the inner cylinder has a through-hole through which the string-shaped member is inserted, in addition to the through-hole through which the shaft-shaped member is inserted. The operation mechanism is formed, and the operation mechanism is connected to a direction changing portion capable of changing the direction of power for moving the inner cylinder to the tip side in the opposite direction to the base end side of the string-shaped member, and the inner cylinder and the said. The present invention relates to a stent delivery system including a transmission unit for transmitting power to and from a string-shaped member.

Further, the stent main body portion has a diameter-expanded portion having a diameter larger than the diameter of the central portion in the expanded state at the end portion on the distal end side, and the diameter-expanded portion has the stent main body portion contracted. In the diameterd state, the string-shaped member is pulled toward the base end side by a predetermined length to increase the diameter, and the transmission part is composed of a reel part fixed to the base end portion of the inner cylinder. It is preferable that the reel portion has a winding gear to which the other end of the string-shaped member is connected so that the string-shaped member can be wound up.

Further, it is preferable that the reel portion further includes a rotation amount regulating member for regulating the rotation amount of the take-up gear.

Further, it is preferable that the reel portion further includes a rotation direction regulating member for regulating the rotation direction of the take-up gear.

According to the present invention, since the tubular member and the axial member can be moved in conjunction with each other in opposite directions, the stent delivery with improved operability when the stent is placed in the constricted portion in the living body. Can provide a system.

It is a schematic diagram which shows the stent delivery system which concerns on 1st Embodiment. It is a schematic diagram for demonstrating the method of placing a stent in a constriction part in 1st Embodiment. It is a figure which shows the state which placed the stent in the constriction part in 1st Embodiment. It is a schematic diagram which shows the stent delivery system which concerns on 2nd Embodiment. It is a perspective view which shows the stent before diameter expansion in 2nd Embodiment. It is a perspective view which shows the stent after diameter expansion in 2nd Embodiment. It is a figure which shows the operation of the diameter expansion mechanism of the stent in 2nd Embodiment, and is the side view before the diameter expansion of a stent. It is a figure which shows the state which the string-like member is pulled from the state shown in FIG. 5A, and the diameter of the stent main body is expanded. FIG. 5B is a diagram showing a state in which a string-shaped member is further pulled from the state shown in FIG. 5B to lock the first engaging member (annular member) to the second engaging member (locking portion). FIG. 5C is a diagram showing a state in which a string-shaped member is further pulled from the state shown in FIG. 5C and the first engaging member (annular member) is locked to the second engaging member (locking portion). It is a schematic diagram for demonstrating the method of placing a stent in a constriction part in 2nd Embodiment. FIG. 6 is a diagram showing a state in which the outer cylinder is slid toward the proximal end side from the state shown in FIG. 6A to expose the tip end portion of the stent. FIG. 6B is a diagram showing a state in which the diameter of the stent main body is expanded by sliding the inner cylinder toward the tip side from the state shown in FIG. 6B. It is a schematic diagram which shows an example of the modification of this invention. It is a schematic diagram which shows the stent delivery system which concerns on 3rd Embodiment. It is a schematic diagram for demonstrating the operation of the operation mechanism at the time of placing a stent in a constriction part in 3rd Embodiment. It is a figure which shows the state which the outer cylinder was slid to the base end side from the state shown in FIG. 9A. It is a figure which shows the state which the inner cylinder was slid to the tip side from the state shown in FIG. 9B. It is a schematic diagram which shows the stent delivery system which concerns on 4th Embodiment. It is a perspective view which shows the reel part. It is a partial exploded view of FIG. 11A. It is explanatory drawing of the rotation amount regulation member in 4th Embodiment. It is a figure which shows the state which the winding gear has rotated 1 rotation from the state before winding the string-like member shown in FIG. 12A. It is a figure which shows the state which the take-up gear has further rotated 2 rotations from the state shown in FIG. 12B. It is explanatory drawing of the rotation direction regulation member in 4th Embodiment. It is a perspective view which shows the stent before diameter expansion in 4th Embodiment. It is a perspective view which shows the stent after diameter expansion in 4th Embodiment. It is a figure which shows the operation of the diameter expansion mechanism of the stent in 4th Embodiment, and is the side view before the diameter expansion of the stent. It is a figure which shows the state which pulled the string-like member from the state shown in FIG. 15A, and mainly expanded the diameter of the end part of the stent main body part. FIG. 15B is a diagram showing a state in which a string-shaped member is further pulled from the state shown in FIG. 15B and the first engaging member (annular member) is locked to the second engaging member (locking portion). It is a schematic diagram for demonstrating the method of placing a stent in a constriction part using the stent delivery system which concerns on 4th Embodiment. FIG. 16A is a diagram showing a state in which the outer cylinder is slid toward the proximal end side from the state shown in FIG. 16A to expose the tip end portion of the stent. FIG. 16B is a diagram showing a state in which the diameter-expanded portion of the stent main body portion is expanded by pulling the string-shaped member toward the proximal end side while winding it on the reel portion from the state shown in FIG. 16B. It is a figure which shows the state which expanded the diameter of the stent main body part by sliding the inner cylinder toward the tip side from the state shown in FIG. 16C. It is a schematic diagram which shows the stent delivery system which concerns on 5th Embodiment. FIG. 5 is a schematic view of a cross section taken along the line AA in FIG. FIG. 5 is a schematic view of a sectional view taken along line BB in FIG.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. In the present specification, the hand side of the stent delivery system is the base end side, and the Y direction is shown in the figure. Further, the side opposite to the hand side of the stent delivery system is the tip side, and the X direction is shown in the figure.

<First Embodiment>
FIG. 1 is a schematic view showing a stent delivery system 1A according to the first embodiment of the present invention, and FIGS. 2A and 2B are schematic views for explaining a method of placing a stent 10A in a constricted portion. As shown in FIG. 1, the stent delivery system 1A includes a stent 10A, an outer cylinder 210 as a tubular member 20A, a guide wire guide tube 30 as a shaft member, a pusher 40A, an operation mechanism 50A, and the like. To be equipped.

The stent delivery system 1A has a length of 1 m to 3 m from the tip end to the base end, and the outer cylinder 20A and the guide wire guide tube 30 have a length corresponding to the length of the stent delivery system 1A.

As the stent 10A, any of metal and resin stents is preferably used, but in the present embodiment, a metal stent having a self-expanding function is used. As a material for the metal stent, a titanium-nickel alloy or the like exhibiting superelasticity is preferably used.

The tubular member 20A is an outer cylinder 210 formed in a tubular shape, and the stent 10A is housed inside the tip side (X direction side). The inner diameter of the outer cylinder 210 may be 2.8 mm to 3.6 mm, for example, as long as the stent 10A can be stored in a contracted (reduced diameter) state in the radial direction. The outer cylinder 210 is made of nylon with a metal blade woven inside, and PTFE (polytetrafluoroethylene) is used as an example for the innermost layer in contact with the stent 10A in order to improve slidability.

The guide wire guide tube 30 is a shaft-shaped member formed in a shaft shape, and a through hole through which a guide wire 60 described later can be inserted is formed from the tip end to the base end.
The guide wire guide tube 30 can be appropriately used in any material and inner / outer diameter as long as it can be arranged so as to be able to advance and retreat inside the outer cylinder 210. However, in the present embodiment, the outer diameter is 1.1 mm and the inner diameter is 1.1 mm. A material of 1.0 mm and a PEEK (polyetheretherketone) resin was used.

The pusher 40A is formed in a disk shape having a diameter corresponding to the inner diameter of the outer cylinder 210, and a through hole through which the guide wire guide pipe 30 is inserted is formed in the central portion. The pusher 40A is attached to the tip end side of the guide wire guide tube 30 so that the stent 10A can be pushed out from the outer cylinder 210. Further, the tip end side (X direction side) of the pusher 40A abuts on the proximal end side (Y direction side) of the stent 10A.
By moving the guide wire guide tube 30 to the tip side with respect to the outer cylinder 210, the pusher 40A attached to the tip side of the guide wire guide tube 30 also moves to the tip side, and the stent 10A is moved from the outer cylinder 210 to the tip side. Can be extruded.
Nylon can be used as the material of the pusher 40A.

The operation mechanism 50A includes an operation base 510, a direction changing unit 520, and a transmission member 530A as a transmission unit. In the present embodiment, the guide wire guide pipe 30 as a shaft-shaped member is moved to the tip end side (X direction side) in conjunction with the operation of moving the outer cylinder 210 to the base end side (Y direction side) by the operation mechanism 50A. It becomes possible to move to.

The operation base 510 is arranged on the proximal end side of the stent delivery system 1A and can be used as a handle during operation.
Further, the base end portion of the outer cylinder 210 is held on the operation base 510 so as to be slidable in the axial direction via the transmission member 530A described later.
In the present embodiment, the operation base 510 is made of a hard resin member, and is formed in a long shape in the length direction of the outer cylinder 210 while holding the outer cylinder 210.

The direction changing unit 520 is formed in a roller shape and is arranged on the base end side (X direction side) of the operation base 510. The direction changing unit 520 is rotatably fixed to the operation base 510. The direction changing unit 520 changes the direction of the power for moving the outer cylinder 210 or the guide wire guide pipe 30 in the opposite direction.
In the present embodiment, the base end side of the guide wire guide pipe 30 is hung on the direction changing unit 520, whereby the base end side of the guide wire guide pipe 30 is changed in direction to the tip side (X direction side). ing.

The transmission member 530A transmits power between the outer cylinder 210 and the guide wire guide pipe 30. In the present embodiment, the transmission member 530A is made of the same resin member as the operation base 510, and is slidably connected in the longitudinal direction of the operation base 510. The transmission member 530A is connected to the base end portion of the guide wire guide pipe 30 whose direction has been changed to the tip end side (Y direction side) in the direction changing unit 520 and the base end portion of the outer cylinder 210.

The guide wire 60 is for guiding the stent delivery system 1A to be inserted into the body. After the guide wire 60 reaches the site where the stent 10A is placed, the guide wire guide tube 30 and the outer cylinder 210 having the guide wire 60 inserted through the through hole are allowed to enter the body to allow the guide wire guide tube 30 and the outside to enter the body. The cylinder 210 can be carried to the target portion.

Subsequently, with reference to FIGS. 2A and 2B, a method of placing the stent 10A in the narrowed portion N in the living body by using the stent delivery system 1A will be described.

The stent delivery system 1A in which the stent 10A is housed inside the outer cylinder 210 is inserted into the forceps opening of an endoscope (not shown). Subsequently, as shown in FIG. 2A, the stent delivery system 1A is arranged so that the distal end side is located in the vicinity of the stenosis portion N. The stent 10A has a length L1 when housed in the outer cylinder 210. In this state, the transmission member 530A is arranged on the tip end side (X direction side) of the operation base 510. Further, until the stent delivery system 1A is arranged in the vicinity of the narrowed portion N, the outer cylinder 210 is maintained in a state of being fixed to the operation base 510 via the transmission member 530A.

Subsequently, from the state of FIG. 2A, the transmission member 530A is slid toward the base end side (Y direction side), and the outer cylinder 210 is moved in the Y direction by a distance of 1 / 2L1 with respect to the operation base 510 (outer cylinder). The 210 is retracted toward the base end side). By retracting the outer cylinder 210 toward the proximal end side, one end of the proximal end portion 310 of the guide wire guide tube connected to the outer cylinder 210 is also retracted toward the proximal end side. As a result, as shown in FIG. 2B, the guide wire guide tube moves from the connection portion with the transmission member 530A to the direction changing unit 520 by a distance of 1 / 2L1 in the Y direction, and is pushed from the direction changing unit 520 to the pusher. A distance of 1 / 2L1 is moved in the X direction toward the tip to which the 40A is attached.

In conjunction with the operation of moving the outer cylinder 210 by a distance of 1 / 2L1 in the Y direction in this way, the guide wire guide tube 30 moves a distance of 1 / 2L1 in the X direction. As a result, as shown in FIG. 2B, the pusher 40A moves with respect to the outer cylinder 210 by a distance of L1 in the X direction, and the stent 10A is pushed out from the outer cylinder 210 and placed in the narrowed portion N. The self-expanding stent 10A expands in diameter at the stenosis N to prevent restenosis.

According to the stent delivery system 1A according to the first embodiment, the following effects are achieved.
(1) In the first embodiment, the outer cylinder 210 as a tubular member, the guide wire guide pipe 30 as a shaft-shaped member, and the outer cylinder 210 and the guide wire guide pipe 30 are interlocked in the opposite directions in the axial direction. The operation mechanism 50A is provided with an operation mechanism 50A for moving the wire, and the operation mechanism 50A includes a direction changing unit 520 and a transmission member 530A. As a result, the outer cylinder 210 moves in conjunction with the guide wire guide pipe 30 in the opposite direction. Therefore, the guide wire guide pipe provided with the pusher is fixed, and the outer cylinder is retracted to the proximal end side to retract the stent. Compared with the case of indwelling, the stent 10A can be indwelled in the narrowed portion N only by retracting the outer cylinder 210 by 1 / 2L1 which is half the length of the stent length L1 in the reduced diameter state. Therefore, the length of the operation of retracting the outer cylinder 210 can be halved, and the operability is improved. In particular, it is suitable for a stent in which the length of the stent becomes long when it is housed in the delivery system.

(2) In the first embodiment, the operation mechanism 50A is further provided with an operation base which is arranged on the base end side and supports the direction changing unit 520. As a result, when operating the stent delivery system 1A, the stent 10A can be placed by operating the transmission member 530A while holding the operation base 510, so that the operability can be further improved.

(3) In the first embodiment, in the operation mechanism 50A, the direction changing unit 520 is formed in a roller shape and is rotatably connected to the operation base 510, and the guide wire guide tube 30 is connected from the outer cylinder 210. It is assumed that the direction is extended to the base end side and the direction is changed to the tip end side by the direction changing unit 520, and one end of the base end side is connected to the transmission member 530A. As a result, power can be transmitted with a simple configuration. Further, the length of the operation mechanism 50A can be shortened in the axial direction, and the space of the stent delivery system 1A can be saved.

(4) In the first embodiment, the outer cylinder 210 as the tubular member 20A is held on the operation base 510 so that the base end portion can slide in the axial direction. As a result, when the stent delivery system 1A is inserted into the body, the positions of the direction changing unit 520 and the outer cylinder 210 are fixed with respect to the operation base 510, so that the stent 10A is at the tip of the outer cylinder 210. It can be kept stored inside. After the stent delivery system 1A reaches the stenosis portion N, the stent 10A can be placed by sliding the outer cylinder 210 in the axial direction with respect to the operation base 510A.

(5) In the first embodiment, the axial member is a guide wire guide tube 30 into which a guide wire 60 for guiding the stent delivery system 1A to be inserted into the body is inserted. As a result, it is not necessary to separately provide a shaft-shaped member for attaching the pusher 40A, and the stent delivery system 1A can be easily configured by using the guide wire guide tube 30 which is an existing configuration used for the stent delivery system 1A. can do.

<Second Embodiment>
Next, a second embodiment of the present invention will be described. In the present embodiment, the stent 10B is provided with the diameter expanding mechanism 120, the stent delivery system 1B uses the inner cylinder 220 instead of the outer cylinder 210 as the tubular member 20B, and the second transmission member 540B. It is different from the first embodiment in that it is further provided. The same components as those in the first embodiment are designated by the same reference numerals and the description thereof will be omitted.

FIG. 3 is a schematic view showing the stent delivery system 1B according to the second embodiment of the present invention, and FIGS. 4A and 4B are perspective views of the stent 10B used in the present embodiment. 5A to 5D are diagrams showing the operation of the diameter expansion mechanism of the stent 10B. 6A to 6C are schematic views for explaining a method of placing the stent 10B in the constricted portion.

The stent delivery system 1B according to the present embodiment will be described with reference to FIG. The stent delivery system 1B includes a stent 10B, an outer cylinder 210, an inner cylinder 220 as a tubular member 20B, a guide wire guide tube 30 as a shaft-shaped member, and an operation mechanism 50B.

The tubular member 20B is an inner cylinder 220 formed in a tubular shape, and is arranged inside the outer cylinder 210 so as to be able to advance and retreat in the axial direction. The distal end side of the inner cylinder 220 is arranged on the proximal end side of the stent 10B described later, and the stent 10B can be pushed out from the outer cylinder 210 by moving (advancing) the inner cylinder 220 toward the distal end side with respect to the outer cylinder 210. Is. Further, the inner cylinder 220 is held by the operation base 510 via the transmission member 530B so that one end (base end) on the base end side (Y direction side) can slide in the axial direction. Further, inside the inner cylinder 220, a guide wire guide pipe 30 is arranged so as to be able to advance and retreat in the axial direction.
Since the inner cylinder 220 can be stored in the outer cylinder 210, the outer diameter is smaller than the inner diameter of the outer cylinder 210, and the guide wire guide pipe 30 can be stored, so that the inner diameter is larger than the outer diameter of the guide wire guide pipe 30. Is also large.

The operation mechanism 50B includes an operation base 510, a direction changing unit 520, a transmission member 530B as a transmission unit, and a second transmission member 540B. In the present embodiment, the guide wire guide pipe as a shaft-shaped member is interlocked with the operation of moving the inner cylinder 220 to the tip side (X direction side) by the operation mechanism 50B (direction changing unit 520 and transmission member 530B). 30 can be moved to the base end side (Y direction side). Further, the outer cylinder 210 can be moved in the axial direction by the operation mechanism 50B (second transmission member 540B).

In the second embodiment, the transmission member 530B transmits power between the inner cylinder 220 and the guide wire guide pipe 30. The transmission member 530B is made of a resin member similar to the operation base 510, and is slidably connected in the longitudinal direction of the operation base 510. The transmission member 530B is connected to the base end portion of the guide wire guide pipe 30 whose direction has been changed to the tip end side (Y direction side) in the direction changing portion 520 and the base end portion of the inner cylinder 220.

Like the transmission member 530B, the second transmission member 540B is made of the same resin member as the operation base 510, and is slidably connected in the longitudinal direction of the operation base 510. The second transmission member 540B is arranged on the tip end side (Y direction side) of the transmission member 530B. The base end portion of the outer cylinder 210 is connected to the second transmission member 540B. As a result, by sliding the second transmission member 540B, the outer cylinder 210 can be moved in the axial direction with respect to the operation base 510 (see FIGS. 6A and 6B).

Next, the configuration of the stent 10B will be described with reference to FIGS. 4A and 4B.
As shown in FIGS. 4A and 4B, the stent 10B includes a stent body 110 and a diameter expanding mechanism 120.

The stent body 110 is formed in a cylindrical shape by the biodegradable fiber material 111. More specifically, the stent main body 110 is woven in a mesh pattern with a plurality of fiber materials 111, and has a large number of diamond-shaped pores formed by the fiber materials 111 on the outer periphery and regularly arranged.

Examples of the biodegradable fiber material 111 include monomers such as L-lactic acid, D-lactic acid, DL-lactic acid, ε-caprolactone, γ-butyrolactone, δ-valerolactone, glycolic acid, trimethylene carbonate, and paradioxanone. Examples include homopolymers, copolymers, and blended polymers thereof synthesized from.

The diameter of the fiber material 111 is preferably 0.05 to 0.7 mm. If the diameter of the fiber material 111 is less than 0.05 mm, the strength of the stent 10B tends to decrease. If the diameter of the fiber material 111 exceeds 0.7 mm, it tends to be difficult to store the stent 10B in the outer cylinder 20B. The upper limit of the diameter of the fiber material 111 is more preferably 0.4 mm and further preferably 0.3 mm from the viewpoint of accommodating the fiber material 111 in the delivery system of the outer cylinder having a smaller inner diameter. The lower limit of the diameter of the fiber material 111 is more preferably 0.2 mm from the viewpoint of maintaining high strength.

The diameter expanding mechanism 120 includes an annular member 121 as a first engaging member, a locking portion 122 as a second engaging member, and a string-shaped member 123. Since the fiber material 111 is made of synthetic resin or the like, it may not have sufficient strength as a stent as compared with a metal stent. Therefore, it is preferable to increase the density and give strength by shortening the stent in the axial direction by using the diameter expanding mechanism 120.

The annular member 121 is provided at the distal end side (X direction side) of the stent main body 110. The annular member 121 is made of synthetic resin fibers, and is formed in an annular shape by connecting both ends of the synthetic resin fibers to the fiber material 111 constituting the stent main body 110. The synthetic resin fiber constituting the annular member 121 may be a monofilament yarn or a multifilament yarn. Further, the synthetic resin fibers constituting the annular member 121 may or may not be twisted. Further, the material may be the same as or different from the fiber material 111 constituting the stent main body 110.

The locking portion 122 is configured so that the annular member 121 can be locked by engaging with the annular member 121 at the end portion of the stent main body 110 on the proximal end side (Y direction side). In the present embodiment, as shown in FIG. 5A, the locking portion 122 is formed by forming the fiber material 111 constituting the stent main body portion 110 in a loop shape. The locking portion 122 may be formed of a synthetic resin fiber other than the fiber material 111.

The string-shaped member 123 connects the first engaging member (annular member) 121 and the guide wire guide pipe 30 as the shaft-shaped member. Specifically, one end of the string-shaped member 123 is connected to the second engaging member (locking portion) 122, extends to the distal end side (X direction side) of the stent main body 110, and is inserted into the annular member 121. Then, the other end extends to the proximal end side (Y direction side) of the stent main body 110 and is connected to the guide wire guide tube 30 as a shaft-shaped member.

The base end portion of the locking portion 122 to which the string-shaped member 123 is connected is made of the fiber material 111 so that one end of the tied string-shaped member 123 does not move to the stent main body 110 side (X direction side). It is preferable to fix the intersection.

A plurality of the above-mentioned diameter expanding mechanisms 120 are arranged at equal intervals in the circumferential direction of the stent main body 110. In this embodiment, as shown in FIGS. 4A and 4B, two diameter expansion mechanisms 120 are arranged.

According to the above-mentioned diameter expanding mechanism 120, in a state where the diameter of the stent main body 110 is reduced, the string-shaped member 123 is pulled toward the proximal end side (Y direction side) of the stent main body 110 to engage with the annular member 121. The annular member 121 and the locking portion 122 are engaged with each other while the portion 122 moves in the approaching direction, and the stent main body portion 110 is maintained in an enlarged diameter state.

Next, the operation of the diameter expanding mechanism 120 will be described with reference to FIGS. 5A to 5D.

In the stent 10B, when the other end side of the string-shaped member 123 is pulled toward the proximal end side (Y direction side) of the stent main body 110, the annular member 121 through which the string-shaped member 123 is inserted is inserted into the stent main body portion by the string-shaped member 123. By being pulled toward the proximal end side of the 110, the annular member 121 and the locking portion 122 move in a direction in which they approach each other.

Next, when the locking portion 122 is further pulled toward the proximal end side (Y direction) of the stent main body 110, the annular member 121 gets over the locking portion 122 formed in a loop shape, as shown in FIG. 5C. The annular member 121 that has passed over the locking portion 122 is pulled toward the tip end side (X direction) by the restoring force (force that tends to extend in the axial direction) of the stent main body portion 110 and is locked to the locking portion 122. As a result, the stent main body 110 is maintained in an expanded state.

Subsequently, with reference to FIGS. 6A to 6C, a method of placing the stent 10B in the narrowed portion N in the living body by using the stent delivery system 1B will be described.

The stent delivery system 1B in which the stent 10B is housed inside the outer cylinder 210 is inserted into the forceps opening of an endoscope (not shown) with the outer cylinder 210 and the inner cylinder 220 fixed to the operation base 510. Subsequently, as shown in FIG. 6A, the stent delivery system 1B is arranged so that the distal end side is located at the distal end of the stenosis N. The stent 10B has a length L2 in a state of being housed in the outer cylinder 210. Further, the annular member 121 has a length a in the axial direction. In this state, the transmission member 530B is arranged on the base end side (Y direction side) of the operation base 510, and the second transmission member 540B is arranged on the tip end side (X direction side) of the operation base 510. ing. Further, until the stent delivery system 1B is arranged in the vicinity of the narrowed portion N, the inner cylinder 220 is maintained in a state of being fixed to the operation base 510 via the transmission member 530B, and the outer cylinder 210 is the second. The state of being fixed to the operation base 510 is maintained via the transmission member 540B.

Subsequently, from the state of FIG. 6A, the second transmission member 540B is slid toward the base end side (Y direction side), and the outer cylinder 210 has the same a as the axial length of the annular member 121 with respect to the operation base 510. Move by a distance (retract the outer cylinder 210 to the base end side). As a result, a part of the stent 10B is exposed from the outer cylinder 210 (see FIG. 6B). Here, the distance a is substantially equal to the axial length of the stent 10B after the diameter expansion, and the tip end portion of the outer cylinder 210 after the slide is approximately the position of the proximal end portion of the stent 10B after the diameter expansion.

Subsequently, from the state of FIG. 6B, the transmission member 530B is moved toward the tip end side (X direction side) by the distance of b (the inner cylinder 220 is advanced toward the tip end side). As a result, the inner cylinder 220 moves to the tip side (X direction side), so that the stent 10B is pushed out from the outer cylinder 210 to the tip side, and the guide wire guide tube 30B as a shaft-shaped member is moved to the base end side (Y). Move to the direction side). In other words, by sliding the inner cylinder 220 toward the tip end side, the guide wire guide tube 30 can be slid toward the base end side by the amount that the string-shaped member 123 loosens, so that the string-shaped member 123 does not loosen. Therefore, in conjunction with the pushing operation of the stent 10B, the string-shaped member 123 is pulled toward the proximal end side, so that the stent 10B is expanded in diameter by the diameter expanding mechanism 120, and the tip of the stent 10B is further extended with respect to the narrowed portion N. It can be prevented from moving (see FIG. 6C). Here, b is substantially equal to the distance that the stent 10B shortens in the axial direction by the diameter expanding mechanism 120, and the relationship of L2≈a + b is established.

Since the position of the outer cylinder 210 can be fixed to the operation base 510, the position of the tip of the stent 10B aligned with the tip of the stenosis N unless the operation base 510 is moved with respect to the stenosis N. Does not move. As a result, by sliding the inner cylinder 220 toward the tip side by the distance b, the tip portion of the outer cylinder 210 aligned with the base end portion of the narrowed portion N and the tip portion of the inner cylinder 220 coincide with each other. The stent 10B is completely pushed out from the outer cylinder 210, and the first engaging member and the second engaging member are engaged by the diameter expanding mechanism 120 to maintain the expanded diameter state.

In this way, the stent 10B can be placed by the stent delivery system 1B. The stent 10B whose diameter is expanded by the diameter expanding mechanism 120 and has sufficient strength can prevent the stenotic portion N from restenosis. Further, after the stent 10B is placed in the narrowed portion N, the string-shaped member 123 is cut at a predetermined position, and the stent delivery system 1B is taken out of the body.

As described above, for example, when a doctor performs an operation of placing a stent, he / she holds the operation base 510, operates the second transmission member 540B, slides the outer cylinder 210 toward the proximal end side, and then transmits the stent. By simply operating the member 530B and sliding the inner cylinder 220 toward the tip end, the operation mechanism 50B can pull the string-shaped member 123 included in the diameter expanding mechanism 120 of the stent 10B toward the proximal end side, and the stent 10B can be pulled. Can be expanded and maintained and placed in a desired position.

As described above, in the present embodiment, the annular member 121 is shown as an example of the first engaging member, and the locking portion 122 is shown as an example of the second engaging member, but the present invention is not limited to this. Any configuration can be applied as long as the first engaging member and the second engaging member can be engaged with each other.

According to the stent delivery system 1B according to the second embodiment, the following effects are obtained.

(6) In the second embodiment, the inner cylinder 220 as the tubular member 20B, the guide wire guide pipe 30 as the shaft-shaped member, and the inner cylinder 220 and the guide wire guide pipe 30 are interlocked in the opposite directions in the axial direction. The operation mechanism 50B includes an operation base 510, a direction changing unit 520, and a transmission member 530B, and the stent 10B is connected to the guide wire guide tube 30. It is assumed that the diameter expanding mechanism 120 including the member 123 is provided. As a result, by sliding the transmission member 530B, the inner cylinder 220 can be moved to the tip end side, and the guide wire guide pipe 30 can be moved to the base end side. Therefore, by sliding the inner cylinder 220 toward the tip side in order to push out the stent 10B from the outer cylinder 210, the guide wire guide tube 30 to which the string-shaped member 123 included in the diameter expanding mechanism 120 of the stent 10B is connected is connected to the base end side. The stent 10B can be expanded in diameter and maintained in that state. Therefore, even for the stent 10B which requires a complicated operation for placement, the operator (doctor) can easily perform the operation of stent placement by one person.

(7) In the second embodiment, in the operation mechanism 50B, the direction changing unit 520 is formed in a disk shape and is rotatably connected to the operation base 510, and the guide wire guide tube 30 is the inner cylinder 220. The direction is changed to the tip side by the direction changing unit 520 extending from the base end side, and one end of the base end side is connected to the transmission member 530B. As a result, power can be transmitted with a simple configuration. Further, the length of the operation mechanism 50B can be shortened in the axial direction, and the space of the stent delivery system 1B can be saved.

(8) In the second embodiment, the outer cylinder 210 and the inner cylinder 220 are independently held by the operation base 510 so that their base ends can slide in the axial direction. As a result, when the stent delivery system 1B is inserted into the body, the direction changing unit 520, the outer cylinder 210 and the inner cylinder 220 can be fixed to the operation base 510, so that the stent 10B is the tip of the outer cylinder 210. Can be kept stored inside the. Further, after the stent delivery system 1B reaches the stenosis portion N, the outer cylinder 210 can be slid toward the proximal end side with respect to the operation base 510 to expose the tip portion of the stent 10B, with respect to the operation base 510. By sliding the inner cylinder 220 toward the tip side, the stent 10B can be placed.

(9) In the second embodiment, the axial member is a guide wire guide tube 30 into which a guide wire 60 for guiding the stent delivery system 1B to be inserted into the body is inserted. As a result, it is not necessary to separately provide a shaft-shaped member for attaching the string-shaped member 123 included in the diameter-expanding mechanism 120 of the stent 10B, and by using the guide wire guide tube 30 which is an existing configuration used in the stent delivery system, The stent delivery system 1B can be easily configured.

(10) In the second embodiment, the stent 10B has a stent main body 110, an annular member 121 as a first engaging member, a locking portion 122 as a second engaging member, and a locking portion at one end. It is connected to 122 and extends to the distal end side of the stent main body 110 and is inserted into the annular member 121, and the other end extends to the proximal end side of the stent main body 110 and is connected to the guide wire guide tube 30 as a shaft-shaped member. It is configured to include a string-shaped member. As a result, the inner cylinder 220 as a tubular member is slid toward the tip end side, and the guide wire guide tube 30 as a shaft-shaped member is slid toward the base end side by the amount of loosening of the string-shaped member 123, and the string-shaped member 123 is used. Can be prevented from loosening. Therefore, with the outer cylinder 210 arranged at the tip of the narrowed portion N, the outer cylinder 210 is slid to the base end side by a predetermined distance (a), and then the inner cylinder 220 is slid to the tip side by a predetermined distance (b). By pulling the string-shaped member 123 connected to the guide wire guide tube 30 to the proximal end side by a predetermined distance (b), the distal end portion and the proximal end portion of the stent 10B after the diameter expansion can be easily positioned. ..

<Modification example>
A modified example of the present invention will be described with reference to FIG. The stent delivery system 1C according to the modified example has a different operation mechanism configuration from the first embodiment and the second embodiment. Since the other configurations are the same as those of the first embodiment and the second embodiment, the description thereof will be omitted. Here, as an example, a configuration including a tubular member and a shaft-shaped member similar to those in the second embodiment will be described except for the operation mechanism.

The operation mechanism 50C includes an operation base 510, a rotary gear 522 as a direction changing unit, and a linear gear 531 and a linear gear 532 as a transmission member 530C.
The rotary gear 522 is rotatably fixed to the operation base 510.
The linear gear 531 is connected to the inner cylinder 220 as a tubular member and can be engaged with the rotary gear 522. The linear gear 531 is axially slidably connected to the operation base 510 via the connecting member 512.
Further, the linear gear 532 is connected to the guide wire guide pipe 30 as a shaft-shaped member and can be engaged with the rotary gear 522.

When the stent 10B is placed in the narrowed portion N in the living body by using the stent delivery system 1C, first, the second transmission member 540C is slid toward the proximal end side (Y direction side) with respect to the operation base 510. The outer cylinder 210 is moved to the proximal end side (Y direction side) by a predetermined distance to expose a part of the stent 10B. Next, the connecting member 512 is slid toward the tip end side (X direction side), and the linear gear 531 connected to the inner cylinder 220 is pushed toward the tip end side (X direction side). The rotary gear 522 rotates in conjunction with the operation of moving the linear gear 531 in the X direction, and the linear gear 532 moves in the Y direction accordingly. As a result, the guide wire guide pipe 30 connected to the linear gear 532 also moves in the Y direction.

According to the stent delivery system 1C according to the modified example, the following effects can be obtained.
(11) In the modified example, the operation mechanism 50C is provided with a rotary gear 522 as a direction changing unit and a linear gear 531 and a linear gear 532 as a transmission member 530C. As a result, the inner cylinder 220 as a tubular member and the guide wire guide pipe 30 as a shaft-shaped member can be moved in conjunction with each other in the axial direction.

<Third Embodiment>
Next, a third embodiment of the present invention will be described with reference to FIGS. 8 and 9. The stent delivery system 1D according to the present embodiment is different from the first embodiment, the second embodiment, and the modified example in the configuration of the operation mechanism and the direction changing unit. Other configurations are the same as those of the first embodiment, the second embodiment, and the modified examples, and thus the description thereof will be omitted. Here, as an example, a configuration including a tubular member and a shaft-shaped member similar to those in the second embodiment will be described except for the operation mechanism and the direction changing unit.

FIG. 8 is a schematic view showing a proximal end side portion of the stent delivery system 1D according to the third embodiment of the present invention, and is a view seen from the front side of the operation base 510 (not shown, see FIG. 9). The stent delivery system 1D according to the present embodiment will be described with reference to FIG. The stent delivery system 1D includes a stent 10B, an outer cylinder 210, an inner cylinder 220 as a tubular member 20D, a guide wire guide tube 30 as a shaft-shaped member, and an operation mechanism 50D.

As shown in FIGS. 8 and 9, the operation mechanism 50D includes an operation base 510, a pin member 523 as a direction changing unit, a transmission member 530D, a second transmission member 540D, and a transmission string 550 as a transmission unit. , Equipped with. In the present embodiment, the guide wire guide pipe 30 as a shaft-shaped member is linked to the operation of moving the inner cylinder 220 to the tip side (X direction side) by the operation mechanism 50D (pin member 523 and transmission string 550). Can be moved to the base end side (Y direction side). Further, the outer cylinder 210 can be moved in the axial direction by the operation mechanism 50D (second transmission member 540D). Further, the inner cylinder 220 can be moved in the axial direction by the operation mechanism 50D (transmission member 530D).

The pin member 523 as the direction changing portion is formed in a shape having a cylindrical portion, and is made of a metal material or a synthetic resin material. Further, two pin members 523 facing each other so as to sandwich the guide wire guide pipe 30 are fixedly arranged on the base end side (X direction side) of the operation base 510. The pin member 523 changes the direction of the power for moving the inner cylinder 220 or the guide wire guide pipe 30 in the opposite direction. In the present embodiment, as shown in FIG. 9, the pin member 523 is formed in a columnar shape in which the diameter of the central portion in the length direction is smaller than the diameter of both end portions. Then, the pin member 523 is fixed to the operation base 510 via the third transmission member 560 so that the axial direction is along the direction perpendicular to the moving direction of the inner cylinder 220 or the guide wire guide pipe 30.
The pin member 523 may be rotatably attached to the third transmission member 560 with the axis perpendicular to the moving direction of the inner cylinder 220 or the guide wire guide tube 30 as the rotation axis. As a result, as will be described later, the load applied to the transmission string 550 hung on the pin member 523 can be reduced.

The transmission member 530D is made of a resin member similar to the operation base 510, and is slidably connected in the longitudinal direction of the operation base 510. As a result, the inner cylinder 220 can be moved in the axial direction with respect to the operation base 510 by sliding the transmission member 530D as shown in FIG. 9C. In the second embodiment, the base end portion of the guide wire guide tube 30 is connected to the transmission member 530B and extends in the X direction (see FIG. 6), but in the third embodiment, the guide wire The base end of the guide tube 30 is configured to extend in the Y direction. As a result, when operating the stent delivery system 1D, the base end portion of the guide wire guide tube 30 is not on the front side of the operator, that is, on the patient side (X direction side), but on the rear side (Y direction side) of the operator. Since it extends to, the base end portion of the guide wire guide tube 30 does not interfere with the operation, and the operability is improved.

Like the transmission member 530D, the second transmission member 540D is made of the same resin member as the operation base 510, and is slidably connected in the longitudinal direction of the operation base 510. The second transmission member 540D is arranged on the tip end side (Y direction side) of the transmission member 530D. The base end portion of the outer cylinder 210 is connected to the second transmission member 540D. As a result, the outer cylinder 210 can be moved in the axial direction with respect to the operation base 510 by sliding the second transmission member 540D as shown in FIG. 9B.

One end of the transmission string 550 as the transmission portion is connected to the base end portion of the inner cylinder 220, the other end is connected to the outer surface of the guide wire guide pipe 30, and is hung on the peripheral surface of the pin member 523. The transmission string 550 is made of a material having low elasticity and high rigidity. Specifically, materials such as polyethylene thread, suture, and piano wire can be used.
Since the inner cylinder 220 and the guide wire guide pipe 30 are connected by the transmission string 550 via the pin member 523, the guide wire guide pipe is linked to the operation of moving the inner cylinder 220 to the tip side (X direction side). It is possible to move 30 to the base end side (Y direction side).

Here, the distance c (see FIG. 8) between the connecting portion between the transmission string 550 and the guide wire guide tube 30 and the pin member 523 is the state before the diameter of the stent 10B is expanded, that is, the inner cylinder 220 advances toward the tip side. It may be longer than the distance b (see FIG. 9C) for sliding the inner cylinder 220 toward the tip side in the state before the inner cylinder 220 is slid. With this configuration, the connection portion between the transmission string 550 and the guide wire guide tube 30 can be operated without interfering with the pin member 523.
Further, by providing the connecting portion between the transmission string 550 and the guide wire guide pipe 30 in the portion inserted into the inner cylinder 220, the distance d between the pin member 523 and the base end portion of the inner cylinder 220 (see FIG. 8) can be set. Can be shortened. Therefore, the length of D of the operating mechanism can be shortened in the axial direction, and space can be saved.

According to the stent delivery system 1D according to the third embodiment, the following effects are obtained.
(12) In the third embodiment, the inner cylinder 220 as the tubular member 20D, the guide wire guide pipe 30 as the shaft-shaped member, and the inner cylinder 220 and the guide wire guide pipe 30 are interlocked in the opposite directions in the axial direction. The operation mechanism 50D includes an operation base 510, a pin member 523 as a direction changing unit, and one end connected to an inner cylinder 220 as a transmission unit, and the other end is a guide wire guide. It is assumed that the diameter expansion mechanism 120 includes a transmission string 550 connected to the tube 30 and hung on the pin member 523, and a string-shaped member 123 in which the stent 10B is connected to the guide wire guide tube 30. As a result, the guide wire guide tube 30 can be moved to the base end side by moving the inner cylinder 220 to the tip end side. Therefore, by sliding the inner cylinder 220 toward the tip side in order to push out the stent 10B from the outer cylinder 210, the guide wire guide tube 30 to which the string-shaped member 123 included in the diameter expanding mechanism 120 of the stent 10B is connected is connected to the base end side. The stent 10B can be expanded in diameter and maintained in that state. Therefore, even for the stent 10B which requires a complicated operation for placement, the operator (doctor) can easily perform the operation of stent placement by one person.

(13) In the third embodiment, the guide wire guide tube 30 as the shaft-shaped member is configured to extend toward the proximal end side (Y direction side). As a result, when operating the stent delivery system 1D, the base end portion of the guide wire guide tube 30 is not on the front side of the operator, that is, on the patient side (X direction side), but on the rear side (Y direction side) of the operator. Since it extends to, the base end portion of the guide wire guide tube 30 does not interfere with the operation, and the operability is improved.

(14) In the third embodiment, in the operation mechanism 50D, one end of the transmission string 550 as the transmission unit is connected to the inner cylinder 220, extends to the base end side, and is moved to the tip side by the pin member 523 as the direction changing unit. The direction was changed so that the other end was connected to the guide wire guide tube 30 as a shaft-shaped member. As a result, power can be transmitted with a simple configuration. Further, by providing the connecting portion between the transmission string 550 and the guide wire guide pipe 30 in the portion inserted into the inner cylinder 220, the distance between the pin member 523 and the base end portion of the inner cylinder 220 can be shortened. Therefore, the length of D of the operating mechanism can be shortened in the axial direction, and space can be saved.

<Fourth Embodiment>
Next, a fourth embodiment of the present invention will be described with reference to FIGS. 10 to 16. In the present embodiment, unlike the stent 10B of the second embodiment, the third embodiment, and the modified example, the transmission member 530E of the stent delivery system 1E is a reel portion in that the stent 10C is further provided with an enlarged diameter portion. It is different from the stent delivery system 1D of the third embodiment in that it is provided with. The same components as those of the above-described embodiments and modifications are designated by the same reference numerals and the description thereof will be omitted.
In the present embodiment, since the stent 10C has a diameter-expanded portion, the string-shaped member 123 is further pulled toward the proximal end side via the transmission string 550 and the guide wire guide tube 30 as compared with the case of the stent 10B. There is a need. Therefore, in order to increase the diameter of the enlarged diameter portion, the portion of the transmission string 550 pulled toward the base end side is wound by the reel portion.

10A and 10B are schematic views showing a stent delivery system 1E according to a fourth embodiment of the present invention, FIGS. 11A and 11B are perspective views of a reel portion, and FIGS. 12A to 12C are rotation amount regulating members in the reel portion. FIG. 13 is an explanatory view of a rotation direction regulating member in the reel portion. 14A and 14B are perspective views of the stent 10C used in the present embodiment, and FIGS. 15A to 15C are views showing the operation of the diameter expansion mechanism of the stent 10C. 16A to 16D are schematic views for explaining a method of placing the stent 10C in the narrowed portion N.

The stent delivery system 1E according to the present embodiment will be described with reference to FIG. The stent delivery system 1E includes a stent 10C, an outer cylinder 210, an inner cylinder 220E as a tubular member 20E, a guide wire guide tube 30 as a shaft-shaped member, and an operation mechanism 50E.

The tubular member 20E is an inner cylinder 220E formed in a tubular shape, and is arranged inside the outer cylinder 210 so as to be able to advance and retreat in the axial direction. The distal end side of the inner cylinder 220E is arranged on the proximal end side of the stent 10C, and the stent 10C can be pushed out from the outer cylinder 210 by moving (advancing) the inner cylinder 220E toward the distal end side with respect to the outer cylinder 210. .. Further, the inner cylinder 220E is held by the operation base 510 via a transmission member 530E, which will be described later, so that one end (base end portion) on the base end side (Y direction side) can slide in the axial direction. Further, inside the inner cylinder 220E, a guide wire guide pipe 30 is arranged so as to be able to advance and retreat in the axial direction.

Further, the inner cylinder 220E is composed of an inner cylinder main body portion 221E made of a flexible resin material and an inner cylinder base end portion 222E made of a rigid material such as a stainless steel pipe. The inner cylinder base end portion 222E constitutes the base end portion of the inner cylinder 220E, has substantially the same diameter as the inner cylinder main body portion 221E, and is inserted into a through hole formed in the transmission member 530E described later. As a result, the base end portion of the inner cylinder 220E can be made rigid, and the operation of pushing out the inner cylinder 220E in the longitudinal direction becomes easy.
Since the inner cylinder 220E can be stored in the outer cylinder 210, the outer diameter is smaller than the inner diameter of the outer cylinder 210, and the guide wire guide pipe 30 can be stored, so that the inner diameter is larger than the outer diameter of the guide wire guide pipe 30. Is also large.

As shown in FIG. 10, the operation mechanism 50E includes an operation base 510, a pin member 524 as a direction changing unit, a transmission string 550 and a transmission member 530E as a transmission unit, a second transmission member 540E, and a third transmission. A member 560E and a member 560E are provided. In the present embodiment, the guide wire guide pipe 30 as a shaft-shaped member is moved to the base end side in conjunction with the operation of moving the inner cylinder 220E to the tip side (X direction side) by the operation mechanism 50E (transmission member 530E). It is possible to move it to (Y direction side). Further, the outer cylinder 210 can be moved in the axial direction by the operation mechanism 50E (second transmission member 540E). Further, the inner cylinder 220E can be moved in the axial direction by the operation mechanism 50E (transmission member 530E).

The pin member 524 as the direction changing portion is formed in a shape having a cylindrical portion, and is made of a metal material or a synthetic resin material. Further, the pin member 524 is fixedly arranged on the base end side (Y direction side) of the operation base 510. The pin member 524 changes the direction of the power for moving the inner cylinder 220E or the guide wire guide tube 30 in the opposite direction. In the present embodiment, the pin member 524 is formed in a columnar shape in which the diameter of the central portion in the length direction is smaller than the diameter of both end portions. The pin member 524 is via the third transmission member 560E so that the length direction is perpendicular to the moving direction of the inner cylinder 220E or the guide wire guide tube 30 and is perpendicular to the paper surface in FIG. Is fixed to the operation board 510.
The pin member 524 is rotatably attached to the third transmission member 560E with an axis perpendicular to the moving direction of the inner cylinder 220 or the guide wire guide tube 30 and perpendicular to the paper surface as a rotation axis in FIG. You may. Thereby, the load applied to the transmission string 550 hung on the pin member 524 can be reduced.

As shown in FIGS. 11A and 11B, the reel portion 5301 as the transmission member 530E includes a reel main body portion 5302, a take-up gear 5303, a rotation amount regulating member 5304, and a rotation direction regulating member 5305. It is fixedly attached to the base end portion of the cylinder 220E.

The reel main body portion 5302 is made of a material such as a metal material or a synthetic resin material, and has a through hole 5302H through which the inner cylinder base end portion 222E made of a stainless steel tube can be inserted, and is formed in the longitudinal direction of the operation base 510. It is slidably connected to.

The take-up gear 5303 is, for example, a spur gear having 36 teeth on the outer circumference, and is rotatably attached to the reel main body portion 5302. The take-up gear 5303 is connected to the ends of two transmission strings 550 extending from the guide wire guide pipe 30 toward the base end side and hung on the pin member 524 to rotate the take-up gear 5303. The transmission string 550 can be wound up by the above method.

The rotation amount regulating member 5304 includes a rotation amount regulation gear 5304G, a rotation amount regulation pinion 5304P, and a rotation amount regulation pin 5304p.
The rotation amount regulation gear 5304G is a spur gear having two teeth that mesh with the rotation amount regulation pinion 5304P on the outer circumference, and is fixed to the take-up gear 5303 on the same rotation shaft as the take-up gear 5303.
The rotation amount regulation pinion 5304P is rotatably attached to the reel main body portion 5302, and a C-shaped through groove as shown in FIG. 11B is formed inside in the circumferential direction.
The rotation amount regulation pin 5304p is fixedly attached to the reel main body portion 5302, and is inserted into the through groove of the rotation amount regulation pinion 5304P to regulate the rotation amount of the rotation amount regulation pinion 5304P.

The rotation direction regulating member 5305 includes a rotation direction regulating pinion 5305P and a stopper 5305S.
The rotation direction regulation pinion 5305P is, for example, a spur gear having 12 teeth on the outer circumference and meshing with the take-up gear 5303, and is rotatably attached to the reel main body portion 5302.
The stopper 5305S is provided to rotate the rotation direction regulation pinion 5305P only in a predetermined direction (clockwise in FIG. 11A), and the stopper main body 5305B, the stopper pin 5305p, and the stopper main body 5305B are attached in the predetermined direction. It includes an elastic member 5305E and a forceful elastic member 5305E. As shown in FIGS. 11A and 11B, the stopper main body 5305B is urged by the elastic member 5305E and arranged between the teeth in the rotation direction regulating pinion 5305P. The stopper pin 5305p regulates the movement of the rotation direction regulating pinion 5305P to rotate counterclockwise by stopping the upward movement of the stopper main body 5305B.
In the present embodiment, the rotation amount regulation pinion 5304P is configured to have the same size as the rotation direction regulation pinion 5305P and arranged so as to have the same rotation axis, and the stopper main body 5304B similar to the stopper main body 5305B is rotated. It is arranged between the teeth in the regulation pinion 5304P, and the stopper main body 5304B is further urged in a predetermined direction by the elastic member 5304E. With this configuration, the rotation direction of the rotation amount regulation pinion 5304P can also be regulated.

The second transmission member 540E is made of the same resin member as the operation base 510, and is arranged on the tip side (X direction side) of the reel portion 5301 as the transmission member 530E as shown in FIG. It is slidably connected in the longitudinal direction of 510. Further, the second transmission member 540E has a handle 541 and is connected to the base end portion of the outer cylinder 210. As a result, the outer cylinder 210 can be moved in the axial direction with respect to the operation base 510 by sliding the second transmission member 540E with the handle 541.

One end of the transmission string 550 as the transmission portion is connected to the take-up gear 5303 of the reel portion 5301, and the other end is connected to the outer surface of the guide wire guide pipe 30 and is hung on the peripheral surface of the pin member 524.
The transmission string 550 is changed in direction by the pin member 524 and is connected to the inner cylinder 220E and the guide wire guide pipe 30 via the reel portion 5301 as the transmission member 530E, so that the inner cylinder 220E is on the tip side (X direction side). ), The guide wire guide tube 30 can be moved to the base end side (Y direction side).

Next, the operation of the rotation amount regulating member 5304 will be described with reference to FIGS. 12A to 12C. In FIGS. 12A to 12C, the take-up gear 5303 is shaded.
In this embodiment, an example is shown in which the take-up gear 5303 is rotated counterclockwise by a predetermined amount in FIG. 12 to wind the transmission string 550. Here, it is assumed that the rotation is approximately 3 times.
As shown in FIG. 12A, before the winding of the transmission string 550 is started, the two teeth of the rotation amount regulation gear 5304G are arranged at the positions immediately after the meshing with the teeth of the rotation amount regulation pinion 5304P is disengaged. Further, the rotation amount regulation pinion 5304P is arranged so that the rotation amount regulation pin 5304p is located at the clockwise end of the through groove.
When the take-up gear 5303 is rotated once counterclockwise from the state shown in FIG. 12A, the rotation amount regulating gear 5304G is also rotated once, and as shown in FIG. 12B, the rotation amount regulating pinion 5304P is rotated clockwise. Rotate by 1/3 of the through groove.
When the take-up gear 5303 is further rotated twice from the state shown in FIG. 12B, the rotation amount regulation gear 5304G also rotates twice in the same manner, and as shown in FIG. 12C, the rotation amount regulation pinion 5304P has a through groove in the clockwise direction. Rotate by 2/3 minutes. As a result, the rotation amount regulation pin 5304p is located at the counterclockwise end of the through groove, and the rotation amount regulation pinion 5304P cannot rotate any more clockwise. Along with this, at the end of a predetermined amount of rotation (approximately 3 rotations) of the take-up gear 5303, the two teeth of the rotation amount regulation gear 5304G are configured to mesh with the teeth of the rotation amount regulation pinion 5304P. As a result, the rotation of the rotation amount regulation pinion 5304P is stopped, and the rotation of the rotation amount regulation gear 5304G and the take-up gear 5303 is also stopped.

Subsequently, the operation of the rotation direction regulating member will be described with reference to FIGS. 12 and 13. In this embodiment, an example of preventing the take-up gear 5303 from rotating clockwise is shown in FIG. In FIG. 13, for the sake of explanation, the rotation amount regulation pinion 5304P is not shown, and only the rotation direction regulation pinion 5305P is shown.
As shown in FIGS. 12A to 12C, when the take-up gear 5303 is rotated counterclockwise to rotate the rotation direction regulation pinion 5305P clockwise, the stopper main body 5305B is formed by the teeth of the rotation direction regulation pinion 5305P. Pushed downward, the elastic member 5305E contracts. Further, if the stopper main body 5305B is not pushed downward by the teeth of the rotation direction regulating pinion 5305P, the stopper main body 5305B returns to the original position by the urging force of the elastic member 5305E. Therefore, the stopper 5305S does not hinder the rotation when the rotation direction regulation pinion 5305P rotates clockwise.
On the other hand, as shown in FIG. 13, when the take-up gear 5303 is rotated clockwise to rotate the rotation direction regulation pinion 5305P counterclockwise, the stopper pin 5305p is used to rotate the stopper main body 5305B. The upward movement is hindered, the teeth of the stopper main body 5305B and the rotation direction regulation pinion 5305P mesh with each other, and the rotation direction regulation pinion 5305P cannot rotate counterclockwise. Therefore, it is possible to prevent the take-up gear 5303 from rotating clockwise. Further, although not shown in FIG. 13, the stopper 5305S can similarly prevent the rotation amount regulation pinion 5304P from rotating counterclockwise. As a result, when the rotation amount regulation gear 5304G is not meshing with the rotation amount regulation pinion 5304P, it is possible to prevent the rotation amount regulation pinion 5304P from rotating counterclockwise, so that the rotation amount can be accurately regulated.

Next, the configuration of the stent 10C will be described with reference to FIGS. 14A and 14B.
As shown in FIGS. 14A and 14B, the stent 10C includes a stent body 110C and a diameter expanding mechanism 120. Since the diameter expanding mechanism 120 is configured in the same manner as in the case of the stent 10B, the description thereof will be omitted.

The stent body 110C is formed in a cylindrical shape by a biodegradable fiber material 111, and has a diameter larger than the diameter of the central portion 112 and the central portion 112 in a state of being arranged at both ends of the central portion 112 and being expanded in diameter. The diameter-expanded portion 113 and the extension portion 114 arranged on the diameter-expanded portion 113 on the base end side are provided. More specifically, the stent main body 110C is woven in a mesh pattern with a plurality of fiber materials 111, and has a large number of diamond-shaped pores formed by the fiber materials 111 on the outer periphery and regularly arranged.

As shown in FIG. 14A, in a state where the diameter of the stent main body 110C is reduced, the mesh of the central portion 112 is formed relatively densely, and the mesh of the enlarged diameter portion 113 is formed relatively coarsely. With this configuration, in the expanded state as shown in FIG. 14B, the stent main body 110C has a larger diameter of the enlarged diameter portions 113 arranged at both ends than the diameter of the central portion 112. can do.

The extending portion 114 is formed by extending a plurality of fiber materials 111 at the proximal end portion of the stent main body 110C toward the proximal end side. Specifically, the extension portion 114 is formed by extending the proximal end side of the plurality of fiber materials 111 outward in the axial direction of the stent main body portion 110C while being slightly separated from the shaft.

The tip of the extension 114 is formed in a loop by connecting the ends of the two fiber materials 111. More specifically, the loop-shaped tip portion is composed of a portion where the fiber material 111 is curved at one end of the stent main body portion 110C. The "two fiber materials 111" here means two fiber materials 111 when paying attention only to the extending portion 114, and in the present embodiment, the "two fiber materials 111" is 1. It is derived from the fiber material 111 of the book.

Next, the operation of the diameter expanding mechanism 120 of the stent 10C will be described with reference to FIGS. 15A to 15C.

When the other end side of the string-shaped member 123 is pulled to the proximal end side (Y direction side) of the stent main body 110C by a predetermined length e (see FIG. 16) from the state shown in FIG. 15A, the stent 10C is a string-shaped member. The annular member 121 through which the 123 is inserted is pulled toward the proximal end side of the stent main body 110 by the string-shaped member 123, so that the annular member 121 and the locking portion 122 move in a direction close to each other. Then, as shown in FIG. 15B, the diameter-expanded portion 113 on the distal end side of the stent main body portion 110C is enlarged in diameter larger than the diameter of the central portion 112.

Next, when the locking portion 122 is further pulled toward the proximal end side (Y direction) of the stent main body 110 from the state shown in FIG. 15B, as shown in FIG. 15C, the central portion 112 and the proximal end side of the stent main body 110C are further pulled. The diameter-expanded portion 113 of the stent is also expanded, and the annular member 121 gets over the locking portion 122 formed in a loop shape, and is subjected to the restoring force (force to extend in the axial direction) of the stent main body portion 110C to the tip side (force to extend in the axial direction). It is pulled in the X direction) and locked to the locking portion 122. As a result, the stent main body 110C is maintained in an expanded state.

Subsequently, with reference to FIGS. 16A to 16D, a method of placing the stent 10C in the narrowed portion N in the living body by using the stent delivery system 1E will be described. In FIGS. 16A to 16D, in order to make the drawings easier to understand, the extension portion 114 in the stent main body portion 110C is not shown, and only one of the two diameter-expanding mechanisms 120 arranged is shown.

The stent delivery system 1E in which the stent 10C is housed inside the outer cylinder 210 is inserted into the forceps opening of an endoscope (not shown) with the outer cylinder 210 and the inner cylinder 220E fixed to the operation base 510. Subsequently, as shown in FIG. 16A, the stent delivery system 1E is arranged at a position where the distal end side exceeds the stenosis portion N. The stent 10C has a length L3 (excluding the extension 114) when it is housed in the outer cylinder 210. Further, the annular member 121 has a length a in the axial direction. In this state, the reel portion 5301 is arranged on the base end side (Y direction side) of the operation base 510, and the second transmission member 540E is arranged on the tip end side (X direction side) of the operation base 510. ing. Further, until the stent delivery system 1E is arranged in the vicinity of the narrowed portion N, the inner cylinder 220E is maintained in a state of being fixed to the operation base 510 via the reel portion 5301, and the outer cylinder 210 is the second. The state of being fixed to the operation base 510 is maintained via the transmission member 540E.

Subsequently, from the state of FIG. 16A, the second transmission member 540E is slid toward the base end side (Y direction side), and the outer cylinder 210 is moved by the distance (a + e) with respect to the operation base 510 (outer cylinder 210). To the base end side). As a result, as shown in FIG. 16B, a part of the stent 10C is exposed from the outer cylinder 210. Here, the distance a is a length corresponding to the axial length of the annular member 121, and the distance e is a length for winding the transmission string 550 on the reel portion 5301. Further, the distance a is substantially equal to the axial length of the stent 10C after the diameter expansion, and the tip end portion of the outer cylinder 210 after the slide is approximately the position of the proximal end portion of the stent 10C after the diameter expansion.

Subsequently, from the state of FIG. 16B, the take-up gear 5303 of the reel portion 5301 is rotated counterclockwise to wind the transmission string 550 by the length e, and as shown in FIG. 16C, the stent main body portion 110C. The diameter of the enlarged diameter portion 113 of the above is increased. As described above, when the take-up gear 5303 is rotated so as to wind the transmission string 550 by the length e, the rotation amount regulation member 5304 (rotation amount regulation gear 5304G, rotation amount regulation pinion 5304P, and rotation amount regulation pin) By configuring 5304p) to function and stop the rotation of the take-up gear 5303, overwinding can be prevented.
Further, by the function of the rotation direction regulating member 5305 (rotation direction regulating pinion 5305P and stopper 5305S), it is possible to prevent the reverse rotation of the winding gear 5303 and the rotation amount regulating pinion 5304P during the winding operation.

Subsequently, from the state shown in FIG. 16C, the reel portion 5301 is moved toward the tip end side (X direction side) by the distance b (the inner cylinder 220E is advanced toward the tip end side). As a result, as shown in FIG. 16D, the inner cylinder 220E moves to the tip side (X direction side), so that the stent 10C is pushed out from the outer cylinder 210 to the tip side and the guide wire guide tube as a shaft-shaped member. 30B moves to the base end side (Y direction side). In other words, by sliding the inner cylinder 220E toward the tip end side, the guide wire guide tube 30 can be slid toward the base end side by the amount that the string-shaped member 123 loosens, so that the string-shaped member 123 does not loosen. Therefore, in conjunction with the pushing operation of the stent 10C, the string-shaped member 123 is pulled toward the proximal end side, so that the stent 10C is expanded in diameter by the diameter-expanding mechanism 120, and further, after the diameter-expanded portion 113 is expanded in diameter. The tip of the stent 10C of the above can be prevented from moving substantially with respect to the narrowed portion N (see FIG. 16D). Here, the length of the stent main body 110C (excluding the extension 114) before the diameter expansion holds the relationship of L3≈a + b + e.
Further, by the function of the rotation direction regulation member 5305 (rotation direction regulation pinion 5305P and stopper 5305S), the take-up gear 5303 and the rotation amount regulation pinion during the operation of moving the reel portion 5301 to the tip side (X direction side). Reverse rotation of 5304P is prevented. Therefore, since the tension of the transmission string 550 is maintained, power can be transmitted between the inner cylinder 220E and the guide wire guide pipe 30 via the reel portion 5301.

In this way, the stent 10C can be placed by the stent delivery system 1E. The stent 10C whose diameter is expanded by the diameter expanding mechanism 120 and has sufficient strength can prevent the stenotic portion N from restenosis. Further, after the stent 10C is placed in the narrowed portion N, the string-shaped member 123 is cut at a predetermined position, and the stent delivery system 1E is taken out of the body.

As described above, for example, when a doctor performs an operation of placing a stent, the outer cylinder 210 is operated by holding the operation base 510 and the handle 541 provided by the second transmission member 540E to move the outer cylinder 210 to the base end side. After sliding to, the transmission string 550 is wound by the take-up gear 5303 of the reel portion 5301 to expand the diameter of the diameter-expanded portion 113, and the reel portion 5301 as the transmission member 530E is operated to move the inner cylinder 220E to the tip side. The string-shaped member 123 included in the diameter-expanding mechanism 120 of the stent 10C can be pulled toward the proximal end by the operation mechanism 50E simply by sliding the stent 10C to a desired position by expanding and maintaining the diameter of the stent 10C. Can be detained.

According to the stent delivery system 1E according to the fourth embodiment, the following effects are exhibited in addition to the above-mentioned effect (13).

(15) In the fourth embodiment, the inner cylinder 220E as the tubular member 20E, the guide wire guide pipe 30 as the shaft-shaped member, and the inner cylinder 220E and the guide wire guide pipe 30 are interlocked in the opposite directions in the axial direction. The operation mechanism 50E includes an operation base 510, a pin member 524 as a direction changing unit, and a transmission string 550 and a transmission member 530E (reel unit 5301) as a transmission unit. One end of the transmission string 550 is connected to the guide wire guide tube 30 as a shaft-shaped member, extends to the base end side, is changed in direction by a pin member 524 as a direction changing portion, and the other end side is a reel. It is assumed that the part 5301 is connected to the take-up gear 5303, and the stent 10C has a diameter-expanding mechanism 120 including a string-shaped member 123 connected to the guide wire guide tube 30. As a result, the guide wire guide tube 30 can be moved to the base end side by moving the reel portion 5301 to the tip end side. Therefore, by sliding the reel portion 5301 toward the tip end side in order to push out the stent 10C from the outer cylinder 210, the guide wire guide tube 30 to which the string-shaped member 123 included in the diameter expanding mechanism 120 of the stent 10C is connected is connected to the base end side. The stent 10C can be expanded in diameter and maintained in that state. Therefore, even for the stent 10C that requires a complicated operation for placement, the operator (doctor) can easily perform the operation of stent placement by one person.

(16) In the fourth embodiment, it is assumed that the stent main body 110C in the stent 10C has a diameter-expanded portion 113 having a diameter larger than the diameter of the central portion 112 in the expanded state at the distal end. The diameter-expanded portion 113 is expanded in diameter by pulling the string-shaped member 123 toward the base end side of a predetermined length e in a state where the diameter of the stent main body 110C is reduced, and the diameter-expanded portion 113 serves as a transmission portion in the operation mechanism 50E. One end of the transmission string 550 is connected to the guide wire guide tube 30 as a shaft-shaped member, extends to the base end side and is changed in direction to the tip end side by a pin member 524 as a direction changing portion, and the other end is a reel portion 5301. It was assumed that it was connected to the take-up gear 5303 in. As a result, since the stent main body 110C has the enlarged diameter portion 113, it is necessary to further pull the string-shaped member 123 toward the base end side by a predetermined length e as compared with the case where the enlarged diameter portion 113 is not provided. By winding the transmission string 550 on the taking gear 5303, the length of the operating mechanism 50E can be shortened in the axial direction, and space can be saved.

(17) In the fourth embodiment, the reel portion 5301 uses a rotation amount regulating member 5304 (rotation amount regulation gear 5304G, rotation amount regulation pinion 5304P, and rotation amount regulation pin 5304p) for regulating the rotation amount of the take-up gear 5303. ) Was provided. As a result, when the winding operation for expanding the diameter of the enlarged diameter portion 113 in the stent main body 110C is performed, the transmission string 550 is wound over a predetermined length e or more required for expanding the diameter of the enlarged diameter portion 113. Can be prevented. Therefore, it is possible to prevent the string-shaped member 123 from being pulled more than necessary in order to increase the diameter of the diameter-expanded portion 113.

(18) In the fourth embodiment, the reel portion 5301 is provided with a rotation direction regulating member 5305 (rotation direction regulation pinion 5305P and stopper 5305S) that regulates the rotation direction of the take-up gear 5303. Thereby, when the diameter-expanded portion 113 in the stent main body 110C is expanded in diameter, the reverse rotation of the take-up gear 5303 can be prevented. Therefore, since the tension of the transmission string 550 is maintained, power can be transmitted between the inner cylinder 220E and the guide wire guide pipe 30 via the reel portion 5301.

(19) In the fourth embodiment, the rotation direction regulating member 5305 also regulates the rotation direction of the rotation amount regulation pinion 5304P. As a result, it is possible to prevent the reverse rotation of the rotation amount regulation pinion 5304P during the winding operation of expanding the diameter of the enlarged diameter portion 113 in the stent main body 110C. Therefore, the amount of rotation of the take-up gear 5303 can be accurately regulated.

<Fifth Embodiment>
Next, a fifth embodiment of the present invention will be described with reference to FIGS. 17 and 18. In the present embodiment, the configurations of the inner cylinder and the transmission portion as the tubular member are different from those in the fourth embodiment. Since other configurations are the same as those of the fourth embodiment, the same reference numerals are given and the description thereof will be omitted.

FIG. 17 is a schematic view showing the stent delivery system 1E according to the fifth embodiment of the present invention, and FIG. 18 is a view for explaining the difference in the configuration of the inner cylinder in the fourth and fifth embodiments. FIG. 18A shows a schematic view of the AA cross section in FIG. 10, and FIG. 18B shows a schematic view of the BB cross section in FIG.

The stent delivery system 1F according to the present embodiment will be described with reference to FIG. The stent delivery system 1E includes a stent 10C, an outer cylinder 210, an inner cylinder 220F as a tubular member 20F, a guide wire guide tube 30 as a shaft-shaped member, and an operation mechanism 50E.

The tubular member 20F is an inner cylinder 220F formed in a tubular shape, and is arranged inside the outer cylinder 210 so as to be able to advance and retreat in the axial direction. The distal end side of the inner cylinder 220F is arranged on the proximal end side of the stent 10C, and the stent 10C can be pushed out from the outer cylinder 210 by moving (advancing) the inner cylinder 220F toward the distal end side with respect to the outer cylinder 210. .. Further, the inner cylinder 220F is held by the operation base 510 via a transmission member 530F, which will be described later, so that one end (base end portion) on the base end side (Y direction side) can slide in the axial direction.
Further, the inner cylinder 220F is composed of an inner cylinder main body portion 221F made of a material such as a flexible resin material and an inner cylinder base end portion 222F made of a rigid material such as a stainless steel pipe. .. As shown in FIG. 18B, the inner cylinder main body 221F has a through hole through which the two string-shaped members 123 are inserted in the axial direction, in addition to the through hole through which the guide wire guide tube 30 is inserted so as to be able to advance and retreat. Two are formed along. Further, since the inner cylinder main body 221F can be stored in the outer cylinder 210, the outer diameter is smaller than the inner diameter of the outer cylinder 210, and the guide wire guide pipe 30 can be stored. The inner diameter of the hole is larger than the outer diameter of the guide wire guide tube 30. As shown in FIG. 17, the inner cylinder base end portion 222F constitutes the base end portion of the inner cylinder 220F, has substantially the same outer shape as the inner cylinder main body portion 221F, and is formed on the transmission member 530F described later. It is inserted through the through hole 5302H. As a result, the base end portion of the inner cylinder 220F can be made rigid, and the operation of pushing out the inner cylinder 220E in the longitudinal direction becomes easy.

Here, with reference to FIG. 18, the difference in configuration between the inner cylinder 220E in the fourth embodiment and the inner cylinder 220F in the present embodiment will be described.
The inner cylinder 220E shown in FIG. 18A has only a through hole through which the guide wire guide pipe 30 is inserted, and the two string-shaped members 123 are arranged between the inner cylinder 220E and the guide wire guide pipe 30. .. Since the inner cylinder 220E and the guide wire guide tube 30 are inserted into the patient's body while being bent in various directions, the inner cylinder 220E is inserted from the tip end to the base end without entwining the string-shaped member 123 in the middle. May be a little difficult.
On the other hand, the inner cylinder 220F shown in FIG. 18B is formed with through holes through which the guide wire guide pipe 30 and the two string-shaped members 123 are separately inserted. Therefore, the two string-shaped members 123 can be inserted from the tip end to the base end of the inner cylinder 220F without being entangled with each other or the guide wire guide pipe 30.

As shown in FIG. 17, the operation mechanism 50F includes an operation base 510, a pin member 524 as a direction changing unit, a string-shaped member 123 and a transmission member 530F as a transmission unit, a second transmission member 540F, and a third. The transmission member 560F and the like are provided. In the present embodiment, the outer cylinder 210 is moved in the axial direction by the operation mechanism 50F (second transmission member 540F). Further, the inner cylinder 220F can be moved in the axial direction by the operation mechanism 50F (transmission member 530F).

As shown in FIG. 17, the reel portion 5301 as the transmission member 530F includes a reel main body portion 5302, a take-up gear 5303, a rotation amount regulating member 5304, and a rotation direction regulating member 5305, and has an inner cylinder 220F. It is fixed and attached to the base end part of.

The take-up gear 5303 is connected to the ends of two string-shaped members 123 extending toward the base end side along the inner cylinder 220F and hung on the pin member 524 to rotate the take-up gear 5303. As a result, the string-shaped member 123 can be wound up.

The second transmission member 540F is made of the same resin member as the operation base 510, is arranged on the tip side (X direction side) of the reel portion 5301 as the transmission member 530F, and slides in the longitudinal direction of the operation base 510. Can be connected. Further, the second transmission member 540F has a handle 541 and is connected to the base end portion of the outer cylinder 210. As a result, the outer cylinder 210 can be moved in the axial direction with respect to the operation base 510 by sliding the second transmission member 540F with the handle 541.

The end of the string-shaped member 123 included in the diameter expanding mechanism 120 of the stent 10C is inserted into a through hole formed in the inner cylinder main body 221F and inserted into the inner cylinder base end 222F to form the base of the inner cylinder 220F. Extends to the edge side. The string-shaped member 123 extending from the inner cylinder 220F to the base end side is hung on the peripheral surface of the pin member 524 as a direction changing portion and extends to the tip end side, and the end portion is the winding gear 5303 of the reel portion 5301. Connected to.
In this way, the string-shaped member 123 is changed in direction by the pin member 524 and is connected to the inner cylinder 220F via the reel portion 5301 as the transmission member 530F, so that the inner cylinder 220F is moved to the tip side (X direction side). The string-shaped member 123 can be moved to the base end side (Y direction side) in conjunction with the operation of making the reel member 123.

According to the stent delivery system 1F according to the fifth embodiment, the following effects are exhibited in addition to the above-mentioned effects (17) to (19).

(20) In the fifth embodiment, the stent delivery system 1F moves the inner cylinder 220F as the tubular member 20F and the string-shaped member 123 included in the inner cylinder 220F and the stent 10C in the opposite direction in the axial direction. The operation mechanism 50F is provided, and the inner cylinder 220F is provided with a through hole through which the string-shaped member 123 is inserted in addition to the through hole through which the guide wire guide pipe 30 is inserted. The operation base 510, the pin member 524 as the direction changing unit, and the transmission member 530F (reel unit 5301) as the transmission unit are provided, and the string-shaped member 123 extending from the inner cylinder 220F to the base end side is provided. , The direction is changed to the tip side by the pin member 524 as the direction changing portion, the end portion is connected to the winding gear 5303 in the reel portion 5301, and the stent 10C has a diameter expanding mechanism 120 provided with the string-shaped member 123. It was supposed to have. As a result, the inner cylinder 220F is formed with through holes through which the guide wire guide pipe 30 and the string-shaped member 123 are separately inserted. Therefore, the string-shaped members 123 can be inserted into the string-shaped members 123 with each other or the guide wire guide pipe. It can be inserted from the tip end to the base end of the inner cylinder 220F without being entangled with 30. Further, by moving the reel portion 5301 to the tip end side, the string-shaped member 123 can be moved to the base end side. Therefore, by sliding the reel portion 5301 toward the tip end side in order to push out the stent 10C from the outer cylinder 210, the string-shaped member 123 provided in the diameter expansion mechanism 120 of the stent 10C is slid toward the base end side to expand the diameter of the stent 10C. And the state can be maintained. Therefore, even for the stent 10C that requires a complicated operation for placement, the operator (doctor) can easily perform the operation of stent placement by one person.

(21) In the fifth embodiment, the stent main body 110C in the stent 10C is provided with a diameter-expanded portion 113 having a diameter larger than the diameter of the central portion 112 in the expanded state at the distal end. The diameter-expanded portion 113 is expanded in diameter by pulling the string-shaped member 123 toward the base end side of a predetermined length e in a state where the stent main body portion 110C is reduced in diameter, and is used as a transmission member 530F in the operation mechanism 50F. The reel portion 5301 of the above is connected to the take-up gear 5303 to which the end portion of the string-shaped member 123 is connected. As a result, since the stent main body 110C has the enlarged diameter portion 113, it is necessary to further pull the string-shaped member 123 toward the base end side by a predetermined length e as compared with the case where the enlarged diameter portion 113 is not provided. By winding the transmission string 550 on the taking gear 5303, the length of the operating mechanism 50F can be shortened in the axial direction, and space can be saved.

Although the preferred embodiments of the stent delivery system of the present invention have been described above, the present invention is not limited to the above-described embodiments and can be appropriately modified.
For example, in the first embodiment, a self-expandable metal stent is used as the stent 10A, but the present invention is not limited to this, and a balloon-expandable metal stent that is not self-expandable or a stent formed of synthetic resin is used. May be good.

Further, in the second embodiment, a biodegradable stent composed of biodegradable fibers is used as the stent, but the stent is not limited to this. That is, the stent may be constructed using synthetic resin fibers that do not have biodegradability, and can also be applied to a metal stent that is not a shape memory alloy, that is, has no self-expanding ability. is there.

Further, in the first to third embodiments and the modified examples, the direction changing portion is composed of a disk-shaped member, a pin-shaped pin member, or a rotary gear, but the present invention is not limited to this. That is, the direction changing unit may be realized by another configuration as long as it is an operation mechanism capable of moving the tubular member and the shaft-shaped member in an axially opposite direction.

Further, although the stent provided with the diameter expanding mechanism has been described in the second embodiment, the diameter expanding mechanism is not limited to the configurations of the first engaging member and the second engaging member described in the second embodiment, and the stent main body portion. It is applicable to the stent delivery system of the present invention as long as the diameter-expanded state of the stent main body is maintained by pulling the string-shaped member connected to the stent to the proximal end side.

Further, in the above-mentioned first embodiment, the second embodiment, and the modified example, the transmission unit is composed of the transmission member, but the present invention is not limited to this. That is, the guide wire guide pipe 30 (shaft member) may be directly connected to the inner cylinder 220 or the outer cylinder 210 (cylindrical member). In this case, it can be said that the transmission portion is composed of a connecting portion between the shaft-shaped member and the tubular member.

Further, in the fourth and fifth embodiments described above, a spur gear having 36 teeth on the outer circumference is shown as an example of the take-up gear, but the transmission string or the string-shaped member can be taken up. If there is, any number of teeth may be used, and gears other than spur gears may be used.

Further, in the fourth embodiment and the fifth embodiment, as an example of the rotation amount regulating member, a configuration in which the rotation amount is regulated by using the rotation amount regulation gear, the rotation amount regulation pinion, and the rotation amount regulation pin is shown. Not limited to this. Any configuration may be used as long as it can regulate the rotation amount of the take-up gear. For example, as a rotation amount control member, one tooth of the take-up gear is formed longer than the other teeth. By stopping only these long teeth at a predetermined position with a pin or a plate-shaped member, the amount of rotation may be restricted to approximately one rotation. Further, a gear having one tooth is used as a rotation amount regulating gear that is attached to the take-up gear and rotates in conjunction with the winding gear, and this one tooth is stopped at a predetermined position by a pin or a plate-shaped member. The rotation amount of the take-up gear may be restricted to approximately one rotation.
Further, in the take-up gear, teeth are continuously formed only on a part of the outer circumference, and the operation gear that meshes with the take-up gear is rotated to rotate the take-up gear by a predetermined rotation amount. May be.
Further, the generator bus top mechanism may be used to regulate the amount of rotation by using the driven side of the generator bus top mechanism as the take-up gear and rotating the drive side of the generator bus top mechanism as the take-up operation gear.

Further, in the fourth embodiment and the fifth embodiment, as an example of the rotation direction regulating member, a configuration in which the rotation of the take-up gear is regulated by using a stopper via a rotation direction regulating pinion is shown, but the present invention is not limited to this. .. Any configuration may be used as long as the rotation direction regulating member has a configuration that can regulate the rotation of the take-up gear in only one direction. For example, in addition to a pin (rotation direction regulating pin) as a member that hinders the movement of the stopper main body in a predetermined direction, a plate-shaped member may be used as a barrier. Further, the shape of the stopper main body may have a beak-shaped shape as shown in FIG. 11 or a knife-shaped shape that becomes thinner by drawing an arc toward the tip.
Further, the stopper may be directly applied to the take-up gear to regulate the rotation direction.
Further, the take-up gear may be a ratchet type gear, and a ratchet claw may be used as a rotation direction regulating member.
Further, the driven gear of the Geneva top mechanism is used as the take-up gear, and the drive side of the Geneva top mechanism is rotated as the take-up operation gear to rotate the take-up gear. The rotation direction of (the driven side of the Geneva top mechanism) may be regulated.

Further, in the fourth embodiment and the fifth embodiment, as an example, a configuration having diameter-expanded portions at both ends of the stent main body is shown, but the diameter-expanded portion is provided only at one end on the distal end side (X direction side). It may have a structure to have.

Further, in the fifth embodiment, as an example, a configuration is shown in which two through holes through which the string-shaped member is inserted are formed in addition to the through holes through which the guide wire guide tube is inserted into the inner cylinder. Not exclusively. Depending on the number of diameter-expanding mechanisms provided in the stent, that is, the number of string-shaped members, a through hole through which each string-shaped member is inserted may be formed in the inner cylinder.

1A, 1B, 1C, 1D, 1E, 1F Stent Delivery System 10A, 10B, 10C Stent 110, 110C Stent Main Body 111 Fiber Material 120 Diameter Expansion Mechanism 121 Circular Member 122 Locking Part 123 String Member 20A Cylindrical Member (Outside) Cylinder)
20B, 20D, 20E, 20F Cylindrical member (inner cylinder)
30 Guide wire guide tube (shaft member)
40A pusher 50A, 50B, 50C, 50D, 50E, 50F Operation mechanism 510 Operation board 520, 522, 523, 524 Direction change unit 530A, 530B, 530C, 530E, 530F Transmission member (transmission unit)
550 Transmission string (transmission part)
N stenosis

Claims (21)

A stent delivery system for placing a stent in vivo.
Cylindrical member and
A shaft-shaped member arranged inside the tubular member so as to be able to move forward and backward in the axial direction,
It is provided with an operation mechanism for moving the tubular member and the shaft-shaped member in an axially opposite direction.
The operation mechanism is
A direction changing unit capable of changing the direction of the power for moving the tubular member or the shaft-shaped member in the axial direction in the opposite direction,
A transmission unit that transmits power between the tubular member and the shaft-shaped member,
Possess an operating foundation provided at the base end side supporting the direction conversion portion,
The direction changing unit is rotatably connected to the operation board and is connected to the operation board.
The shaft-shaped member extends from the tubular member to the proximal end side, is folded back by being hung over the direction changing portion, extends from the direction changing portion to the distal end side, and one end on the proximal end side reaches the transmitting portion. Stent delivery system to be connected. A stent delivery system for placing a stent in vivo.
Cylindrical member and
A shaft-shaped member arranged inside the tubular member so as to be able to move forward and backward in the axial direction,
It is provided with an operation mechanism for moving the tubular member and the shaft-shaped member in an axially opposite direction.
The operation mechanism is
A direction changing unit capable of changing the direction of the power for moving the tubular member or the shaft-shaped member in the axial direction in the opposite direction,
It has a transmission unit that transmits power between the tubular member and the shaft-shaped member.
The transmission unit has one end connected to the proximal end of the tubular member, the other end is connected to the shaft-like member, Luz tent delivery system is configured by the transmission straps passed over the direction changing part. The operating mechanism, the stent delivery system of claim 2, Ru further comprising an operation foundation provided at the base end side supporting the direction conversion unit. The stent delivery system according to claim 1 or 3, wherein the tubular member is held on the operation board so that the base end portion can slide in the axial direction. The tubular member is an outer cylinder capable of accommodating the stent inside the tip side.
The stent delivery system according to any one of claims 1 to 4 , further comprising an pusher arranged on the distal end side of the shaft-shaped member and capable of pushing the stent out of the outer cylinder. A stent delivery system for placing a stent in vivo.
An outer cylinder that can store the stent inside the tip side,
Are disposed to be retractable inside the front Symbol outer cylinder in the axial direction, and the inner tube der Ru tubular member capable extruding the stent from the outer tube at the distal end,
A shaft-shaped member arranged inside the tubular member so as to be able to move forward and backward in the axial direction,
It is provided with an operation mechanism for moving the tubular member and the shaft-shaped member in an axially opposite direction.
The operation mechanism is
A direction changing unit capable of changing the direction of the power for moving the tubular member or the shaft-shaped member in the axial direction in the opposite direction,
It has a transmission unit that transmits power between the tubular member and the shaft-shaped member.
The stent is
A stent body that is formed by knitting into a cylindrical shape with a fiber material and can be deformed from a reduced diameter state to an expanded state.
A first engaging member provided at the distal end of the stent body and
A second engaging member provided at the proximal end side of the stent body and capable of engaging with the first engaging member.
It has a string-shaped member that connects the first engaging member and the shaft-shaped member.
In a reduced diameter state, the stent body is contracted in the axial direction and expanded in diameter by pulling the string-shaped member toward the proximal end side, and the first engaging member and the second engaging member are expanded. Luz tent delivery system engaging member of the engaging member and the second first are engaged, are kept in expanded state with the engaging member moves in a direction coming close to the. An outer cylinder capable of accommodating the stent is further provided inside the tip side.
The tubular member is an inner cylinder that is arranged inside the outer cylinder so as to be able to advance and retreat in the axial direction, and the stent can be pushed out from the outer cylinder at a tip portion.
The stent is
A stent body that is formed by knitting into a cylindrical shape with a fiber material and can be deformed from a reduced diameter state to an expanded state.
A first engaging member provided at the distal end of the stent body and
A second engaging member provided at the proximal end side of the stent body and capable of engaging with the first engaging member.
It has a string-shaped member that connects the first engaging member and the shaft-shaped member.
In the reduced diameter state, the stent main body is contracted in the axial direction and expanded in diameter by pulling the string-shaped member toward the proximal end side, and the first engaging member and the second engaging member are expanded. The stent according to claim 2 , wherein the first engaging member and the second engaging member are engaged with each other and maintained in an expanded state while moving in a direction in which the first engaging member and the second engaging member are approaching each other. Delivery system. The operation mechanism further includes an operation base provided on the base end side and supporting the direction changing unit.
The stent delivery system according to claim 6 or 7 , wherein the outer cylinder is held on the operation board so that the base end portion can slide in the axial direction. The first engaging member is an annular member formed of a fiber material.
The second engaging member is a locking portion formed of a fiber material and capable of locking the annular member.
One end of the string-shaped member is connected to the locking portion, extends to the distal end side of the stent main body portion and is inserted into the annular member, and the other end extends to the proximal end side of the stent main body portion to extend the shaft. The stent delivery system according to any one of claims 6 to 8 , which is connected to a shape member. The stent delivery system according to any one of claims 1 to 9 , wherein the axial member is a guide wire guide tube into which a guide wire for guiding the stent delivery system to be inserted into the body is inserted. The stent body is
At the end on the tip side, there is a diameter-expanded portion that has a diameter larger than the diameter of the central portion in the expanded state.
The diameter-expanded portion is expanded by pulling the string-shaped member toward the proximal end side of a predetermined length in a state where the stent main body portion is reduced in diameter.
The transmission unit
A transmission string whose one end side is connected to the shaft-shaped member and is hung on the direction changing unit,
A reel portion provided fixed to the base end portion of the inner cylinder is provided.
The stent delivery system according to claim 6 , wherein the reel portion has a winding gear to which the other end side of the transmission string is connected and the transmission string can be wound. A stent delivery system for placing a stent in vivo.
The stent is
A stent body that is formed by knitting into a cylindrical shape with a fiber material and can be deformed from a reduced diameter state to an expanded state.
A first engaging member provided at the distal end of the stent body and
A second engaging member provided at the proximal end side of the stent body and capable of engaging with the first engaging member.
The tip side has a string-shaped member connected to the first engaging member, and has.
In the reduced diameter state, the stent main body is contracted in the axial direction and expanded in diameter by pulling the string-shaped member toward the proximal end side, and the first engaging member and the second engaging member are expanded. The first engaging member and the second engaging member are engaged with each other as the engaging member moves in the approaching direction, and the diameter is maintained in an expanded state.
The stent delivery system
An outer cylinder that can store the stent inside the tip side,
An inner cylinder that is arranged inside the outer cylinder so as to be able to move forward and backward in the axial direction and that can push the stent out of the outer cylinder at the tip portion.
A shaft-shaped member arranged inside the inner cylinder so as to be able to advance and retreat in the axial direction, and inside the inner cylinder so as to be able to advance and retreat in the axial direction.
It is provided with an operation mechanism for moving the string-shaped member toward the base end side in conjunction with the movement of the inner cylinder toward the tip end side.
In the inner cylinder, apart from the through hole through which the shaft-shaped member is inserted, a through hole through which the string-shaped member is inserted is formed along the axial direction.
The operation mechanism is
A direction changing unit that can change the direction of the power that moves the inner cylinder to the tip side in the opposite direction,
A transmission unit that is connected to the base end side of the string-shaped member and transmits power between the inner cylinder and the string-shaped member.
Stent delivery system with. The stent delivery system according to claim 12 , wherein the operating mechanism is further provided with an operating base provided on the proximal end side to support the direction changing portion. The stent according to claim 13 , wherein the string-shaped member extends from the inner cylinder toward the proximal end side, is hung on the direction changing portion, and one end on the proximal end side is connected to the proximal end portion of the inner cylinder. Delivery system. The stent delivery system according to claim 13 or 14 , wherein the inner cylinder is held on the operation board so that the base end portion can be slidably slid in the axial direction. The stent delivery system according to any one of claims 13 to 15 , wherein the outer cylinder is held on the operation board so that the base end portion can slide in the axial direction. The first engaging member is an annular member formed of a fiber material.
The second engaging member is a locking portion formed of a fiber material and capable of locking the annular member.
One end of the string-shaped member is connected to the locking portion, extends to the distal end side of the stent main body portion and is inserted into the annular member, and the other end extends to the proximal end side of the stent main body portion to extend the shaft. The stent delivery system according to any one of claims 12 to 16 , which is connected to a shape member. The stent delivery system according to any one of claims 12 to 17 , wherein the axial member is a guide wire guide tube into which a guide wire for guiding the stent delivery system to be inserted into the body is inserted. The stent body is
At the end on the tip side, there is a diameter-expanded portion that has a diameter larger than the diameter of the central portion in the expanded state.
The diameter-expanded portion is expanded by pulling the string-shaped member toward the proximal end side of a predetermined length in a state where the stent main body portion is reduced in diameter.
The transmission portion is composed of a reel portion that is fixedly provided to the base end portion of the inner cylinder.
The stent delivery system according to any one of claims 12 to 18 , wherein the reel portion has a winding gear to which the other end of the string-shaped member is connected and the string-shaped member can be wound. The stent delivery system according to claim 11 or 19 , wherein the reel portion further includes a rotation amount regulating member for regulating the rotation amount of the take-up gear. The stent delivery system according to any one of claims 11 , 19 and 20 , wherein the reel portion further includes a rotation direction regulating member for regulating the rotation direction of the take-up gear.

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