JP2015192727A - tube stent delivery device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To easily and reliably adjust a position of a tube stent in a narrow section such as the biliary tract.SOLUTION: A tube stent delivery device 1 used for placing a tube stent in a lumen, includes: an inner sheath 21 having a wire lumen into which a guide wire can be inserted, and an air lumen for distributing air; an outer sheath 22 into which the inner sheath is slidably inserted; and a balloon 23 provided at a distal side of the inner sheath, inflated by supplying air in the interior thereof via the air lumen, and deflated by sucking of the air.

Description

  The present invention relates to a tube stent delivery device used for indwelling a tube stent in a stricture such as a bile duct.

  Biliary drainage is generally performed as a treatment to secure the flow of bile by inserting a hollow tube stent into a narrowed part of the bile duct or the like where the flow of bile has deteriorated due to gallstones or tumors. Yes. As a tube stent delivery device, which is an endoscopic treatment tool used for performing endoscopically this biliary drainage, for example, as disclosed in the following Patent Document 1 and Patent Document 2, A pusher sheath is slidably fitted on a sheath.

  The tube stent as an indwelling object is fitted on the distal end side of the inner sheath in a state of being arranged in series with the pusher sheath, and the tube stent is positioned in a fixed manner with respect to the inner sheath. Is inserted into the stenosis, the inner sheath is pulled out with the position of the pusher sheath fixed, and the pusher sheath is pulled out, so that the tube stent is placed in the stenosis.

  In this type of delivery device, the position of the tube stent can be adjusted in the push-in direction (insertion direction) in a constricted portion such as a bile duct, but some contrivance is required in the pull-out direction (extraction direction). For this reason, in the technique described in Patent Document 1, the frictional force against the tube stent (drainage tube) in the vicinity of the distal end of the inner sheath (guide tube) can be increased to adjust the position of the tube stent in the removal direction. It is said.

  In the technique described in Patent Document 2, the inner sheath (inner catheter) and the tube stent (stent) are connected with a string to enable adjustment in the tube stent removal direction. When sliding in the direction of pulling out from the pusher sheath, the connection between the tube stent and the pusher sheath by the string is released.

JP 2000-152985 A JP 2012-239803 A

  However, in the technique described in Patent Document 1, since the tube stent or the like has an error in manufacturing, the frictional force is not necessarily constant depending on the individual, and when the frictional force does not act properly, the tube stent is removed in the direction of removal. There is a problem that the position cannot be adjusted. In addition, when pulling out the inner sheath from the tube stent, a frictional force will inevitably act. Therefore, it is necessary to pull out the pusher sheath so as to overcome the frictional force while keeping the pusher sheath firmly fixed so that the position does not shift. When the position of the pusher sheath is unintentionally shifted, there is a problem that the position of the tube stent arranged at an appropriate folding angle may move.

  In addition, in the technique described in Patent Document 2, it is necessary to form a hole or the like for connecting to a tube stent to be placed with a string, and a part of the string is disposed when arranged at the distal end portion of the inner sheath. There is a problem that it is necessary to insert the inner sheath into the pusher sheath in a state where the (kump) is inserted into the hole formed in the distal end portion of the pusher sheath, and the operation is not always easy. In addition, the string may get tangled in the vicinity during the procedure, which may hinder the procedure.

  The present invention has been made in view of these points, and an object of the present invention is to provide a tube stent delivery device capable of easily and reliably adjusting the position of the tube stent in a stenosis portion or the like in a lumen. To do.

The tube stent delivery device according to the present invention is:
A tube stent delivery device used to place a tube stent in a lumen,
An inner sheath having an air lumen through which air is circulated, the distal end side being inserted into the tube stent, and the tube stent being disposed on the distal end side;
An outer sheath through which the inner sheath is slidably inserted;
A balloon which is provided on a distal end side of the inner sheath, expands when air is supplied to the inside through the air lumen, and contracts when the air is sucked. To do.

In the tube stent delivery device according to the present invention,
In the state where the tube stent is disposed on the distal end side of the inner sheath such that the end surface on the proximal end side of the tube stent contacts the end surface on the distal end side of the outer sheath, It can provide so that it may be located inside the said tube stent.

In the tube stent delivery device according to the present invention,
In the state where the tube stent is disposed on the distal end side of the inner sheath such that the end surface on the proximal end side of the tube stent abuts on the end surface on the distal end side of the outer sheath, It can be provided so as to be located outside the distal end of the tube stent.

  In this case, as the balloon, a balloon having a substantially conical shape whose diameter becomes smaller toward the tip in an expanded state can be used.

In the tube stent delivery device according to the present invention, when the balloon is provided so as to be located inside the tube stent,
The balloon is a first balloon, the air lumen is a first air lumen, and is provided on the distal end side of the inner sheath with respect to the first balloon. A second balloon that expands when air is supplied to the inside thereof through a second air lumen formed in the air lumen and contracts when the air is sucked;
The tube stent is disposed on the distal side of the inner sheath such that the end surface on the proximal end side of the tube stent is in contact with the end surface on the distal end side of the outer sheath. The tube stent can be provided outside the distal end of the tube stent.

  In this case, as the second balloon, a balloon having a substantially conical shape whose diameter becomes smaller toward the tip in the expanded state can be used.

  According to the present invention, the balloon provided on the distal end side of the inner sheath is expanded to fix the position of the tube stent relative to the inner sheath, or to slide the tube stent relative to the inner tube toward the distal end. On the contrary, the balloon can be deflated to release the fixed position of the tube stent relative to the inner sheath, or to release the slide restriction. Therefore, the position of the tube stent can be arbitrarily pulled back by expanding the balloon, and the fixation of the tube stent by the inner tube can be arbitrarily released by contracting the balloon. Therefore, there is an effect that the position adjustment of the tube stent in the stenosis part or the like in the lumen can be easily and reliably performed.

It is a top view which shows the whole structure of the tube stent delivery apparatus of embodiment of this invention. It is sectional drawing along the AA line of FIG. It is sectional drawing along the BB line of FIG. It is sectional drawing which shows the structure of the distal end side of the tube stent delivery apparatus of embodiment of this invention, Comprising: It is a figure which shows the time of balloon shrinkage | contraction. It is sectional drawing which shows the structure of the distal end side of the tube stent delivery apparatus of embodiment of this invention, Comprising: It is a figure which shows the time of balloon expansion. It is a figure which shows the structure of the proximal end side of the tube stent delivery apparatus of embodiment of this invention. It is sectional drawing which shows the structure of the proximal end side of the tube stent delivery apparatus of embodiment of this invention. It is sectional drawing which shows the structure of the distal end side of the tube stent delivery apparatus of other embodiment of this invention, Comprising: It is a figure which shows the time of balloon expansion | swelling. It is sectional drawing which shows the structure of the distal end side of the tube stent delivery apparatus of further another embodiment of this invention, Comprising: It is a figure which shows the time of balloon inflation. It is sectional drawing which shows the structure of the distal end side of the tube stent delivery apparatus of further another embodiment of this invention, Comprising: It is a figure which shows the time of balloon inflation.

  Hereinafter, a tube stent delivery device according to an embodiment of the present invention will be specifically described with reference to the drawings. The tube stent delivery device according to the present embodiment is a medical treatment tool used to place a tube stent in a narrowed portion of a bile duct, and is an endoscope that is inserted into a bile duct via a treatment tool guide tube of an endoscope. It is a device of the method.

  However, the present invention is not limited to this, and can be widely applied to a tube stent delivery device used for indwelling a tube stent in a lumen. Further, the present invention can be applied to not only the bile duct but also the pancreatic duct, blood vessels, and other lumens. Furthermore, the present invention can be applied not only to an endoscope type that is inserted through a treatment instrument guide tube of an endoscope, but also to a percutaneous type that is directly approached by inserting a needle. In the present invention, the tube stent refers to a cylindrical type whose diameter is fixed, and does not include an expandable stent whose diameter is expanded after being inserted into a stenosis or the like.

  First, reference will be made to FIGS. A tube stent delivery device 1 according to this embodiment includes an elongated catheter portion 2 inserted into a patient's body (lumen) via a treatment instrument guide tube of an endoscope (not shown) and a proximal end side of the catheter portion 2. And an operation part 3 for operating the catheter part 2 in the body from the outside of the body and a tube stent 5 as an indwelling object. Although the vicinity of the distal end of the catheter part 2 including the tube stent 5 is actually curved, it is drawn linearly for convenience in FIG.

  The catheter unit 2 includes an inner sheath (inner tube) 21 having a distal end and a proximal end, and an outer sheath (outer tube) 22 having a distal end and a proximal end. An outermost tube (not shown) arranged concentrically with the outer sheath 22 may be provided so as to cover the outer periphery of the outer sheath 22. Contrast markers (not shown) may be attached to the vicinity of the distal ends of the inner sheath 21 and the outer sheath 22, respectively.

  In addition, when providing an outermost tube, the thing larger about 0.05-1.0 mm than the outer diameter of the outer sheath 22 can be used. As the material of the outermost tube, polyacetal, polytetrafluoroethylene, tetrafluoroethylene / hexafluoropropylene copolymer, polypropylene or the like can be used. Further, the contrast marker is a marker in the body whose position is detected by X-ray fluoroscopy, and is formed of, for example, a metal material such as gold, platinum, tungsten, or a polymer blended with barium sulfate or bismuth oxide. Is done. When a contrast marker is attached near the distal end of the inner sheath 21 and / or the outer sheath 22, the position of the contrast marker can be detected by X-ray fluoroscopy.

  The inner sheath 21 is made of an elongated tube having flexibility, and a wire lumen (wire tube for inserting a guide wire 4 used as a guide for inserting the tube stent delivery device 1 into a patient's body is inserted therein. Road) 21a and air lumen (air duct) 21b are formed. After the guide wire 4 is inserted into the body to secure the path between the outside and inside the body, the catheter portion 2 is pushed along the guide wire 4 inserted into the wire lumen 21a of the inner sheath 21 constituting the catheter portion 2 ( The distal end side of the catheter part 2 can be inserted into the target site in the body. The outer diameter of the inner sheath 21 is about 0.5 to 4.0 mm.

  As will be described in detail later, a balloon 23 is provided on the distal end side of the inner sheath 21, and the air lumen 21b circulates air in order to drive the balloon 23 to expand and contract. The distal end of the air lumen 21b reaches the middle part of the balloon 23, and communicates with the internal space of the balloon 23 through the intake / exhaust port 21c. Although the number of intake / exhaust ports 21c is one in the present embodiment, a plurality of intake / exhaust ports may be provided.

  In the present embodiment, the outer diameter of the inner sheath 21 is the same throughout, but there are two lumens (wire lumens) from the proximal end of the inner sheath 21 to the intake / exhaust port 21c on the distal end side. 21a, the air lumen 21b) and the distal end side of the inner sheath 21 from the intake / exhaust port 21c is a single lumen (wire lumen 21a). You may set smaller than the diameter of the proximal end side rather than the intake / exhaust port 21c.

  The outer sheath (pusher sheath) 22 is formed of a flexible elongated tube, has an inner diameter slightly larger than the outer diameter of the inner sheath 21, and the inner sheath 21 is slidably inserted therein. . A predetermined gap is formed between the outer peripheral surface of the inner sheath 21 and the inner peripheral surface of the outer sheath 22 so that a balloon 23 (described in detail later) in a contracted state can pass therethrough. The inner diameter of the outer sheath 22 is about 0.5 to 4.5 mm, and the outer diameter is about 1.0 to 5.0 mm. The proximal end of the outer sheath 22 is connected to the operation unit 3, and by operating the operation unit 3, the outer sheath 22 can slide (relatively move) in the axial direction with respect to the inner sheath 21. .

  Examples of the material for the inner sheath 21 and the outer sheath 22 include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, polyesters such as polyethylene terephthalate and polybutylene terephthalate, polyamide, and polyether polyamide. Various resin materials such as polyester polyamide, fluorine resin such as polytetrafluoroethylene and tetrafluoroethylene / hexafluoropropylene copolymer, styrene, polyolefin, polyurethane, polyester, polyamide, polybutadiene, etc. Various thermoplastic elastomers can be used. Two or more of these can be used in combination.

  The tube stent 5 is an elongated flexible tube made of a resin such as polyethylene, for example, and is a medical instrument for an endoscope that is inserted and placed in a narrowed portion of the bile duct to ensure the flow of bile and the like. It is. Although illustration is omitted, the tube stent 5 may be provided with flaps and side holes. Various lengths, diameters, etc. of the tube stent 5 are prepared according to the patient's physique, the site to be placed, etc. As an example, the length is about 20 mm to 200 mm and the diameter is 1.0-5.0 mm Degree. In the present embodiment, the tube stent 5 is described as one of the constituent members of the tube stent delivery device 1, but the tube stent 5 may be exchanged as a separate member from the tube stent delivery device 1. .

  The tube stent 5 has a distal end side portion of the inner tube 21 inserted therein, and the proximal end side end surface of the tube stent 5 has a distal end side of the outer sheath 22 through which the inner sheath 21 is inserted. By being in contact with the end surface of the outer sheath 22, the outer sheath 22 is arranged in series.

  The operation unit 3 includes a connector 31, a hub 32, an intake / exhaust tube 33, a connector 34, and a syringe 35. As shown in FIGS. 6 and 7, the connector 31 is integrally connected and fixed to the proximal end of the outer sheath 22, and has a substantially conical recess 31 a on the proximal end side. Yes.

  The hub 32 is a substantially cylindrical member having a substantially conical convex portion 32a that fits into the concave portion 31a of the connector 31 on the distal end side, and the proximal end of the inner sheath 21 is integrated with the tip of the convex portion 32a. Connection is fixed. Inside the hub 32, a wire lumen 32 b communicating with the wire lumen 21 a of the inner sheath 21 is formed, and an air lumen 32 c communicating with the air lumen 21 b of the inner sheath 21 is formed.

  One end of the intake / exhaust tube 33 is integrally connected and fixed to the proximal end of the hub 32 so as to communicate with the air lumen 32 c of the hub 32. Here, the inner sheath 21, the hub 32, and the intake / exhaust tube 33 are described as being configured as separate members and integrated with each other later, but as shown in FIG. The inner sheath 21 and the intake / exhaust tube 33 may be integrally formed and inserted into the through hole of the hub 32 and fixed. Although not shown in the figure, the connector 31 and the hub 32 can be coupled to or decoupled from each other by a luer lock system in a state where the convex portion 31a is inserted into the concave portion 32a.

  The guide wire 4 is inserted into the wire lumen 21a of the inner sheath 21 and the wire lumen 32b of the hub 32, and an operation member 4a is attached to a portion of the proximal end side exposed from the wire lumen 32b of the hub 32. Yes. A connector 34 is integrally attached to the other end of the intake / exhaust tube 33, and a syringe 35 is connected to the connector 34. The connector 34 and the syringe 35 can be coupled or released from each other by a luer lock method.

  By operating the syringe 35, air is supplied into the balloon 23 via the intake / exhaust tube 33, the air lumen 32c of the hub 32, the air lumen 21b of the inner sheath 21, and the intake / exhaust port 21c, or inside the balloon 23 The air can be sucked. Although not shown, the syringe 35 is provided with a scale for measuring the amount of air supplied to the balloon 23 so that the diameter of the balloon 23 can be arbitrarily controlled.

  As shown in FIGS. 4 and 5, the balloon 23 provided on the distal end side of the inner sheath 21 is an intake / exhaust port 21 c (FIG. 3 or FIG. 3) formed on the distal end side of the inner sheath 21. 7). The balloon 23 is formed of an elastomer material or a resin material, and is operated so as to exhaust the syringe 35, and the intake / exhaust tube 33, the air lumen 32c of the hub 32, the air lumen 21b of the inner sheath 21, and the intake / exhaust port 21c. When air is supplied to the inside of the balloon 23 via the balloon 23, the balloon 23 is expanded, and the expanded stent 23 can fix the tube stent 5 to the inner sheath 21 (see FIG. 5).

  On the contrary, by operating the syringe 35 to suck in air, the air inside the balloon 23 is sucked through the intake / exhaust tube 33, the air lumen 32c of the hub 32, the air lumen 21b of the inner sheath 21, and the intake / exhaust port 21c. Then, the balloon 23 is deflated and the tube stent 5 can be released from the inner sheath 21 (see FIG. 4).

  Specific examples of the elastomer material forming the balloon 23 include natural rubber, silicone rubber, polyurethane elastomer, polyamide elastomer, and the like. Specific examples of the resin material include polyamide resin, polyethylene terephthalate resin, polyvinylidene fluoride resin, and the like. Can be mentioned. As shown in FIG. 4, the balloon 23 is cylindrical as a whole, the length of the balloon 23 (the length along the axial direction of the inner sheath 21) is about 5 to 20 mm, and the wall thickness is It is about 0.05 to 0.25 mm. The balloon 23 can be attached to the inner sheath 21 at the joints 23a and 23a by, for example, bonding with an adhesive, thermal fusion, welding with a solvent, ultrasonic welding, or the like.

  When the tube stent 5 is placed in a stenosis portion in the bile duct, first, the guide wire 4 is inserted through the bile duct through the stenosis portion through the treatment instrument guide tube of the endoscope. Next, the connector 31 and the hub 32 are coupled (locked) to each other, and the distal end of the inner sheath is placed so that the end surface on the proximal end side of the tube stent 5 abuts on the end surface on the distal end side of the outer sheath 22. The catheter part 2 is inserted along the guide wire 4 as a whole in a state of being arranged on the end side. At this time, the balloon 23 is in a deflated state.

  Next, the connection (lock) between the connector 31 and the hub 32 is released, the outer sheath 12 is slid to the distal end side with respect to the inner sheath 21, the tube stent 5 is advanced, and the stenosis portion is adjusted. The tube stent 5 is pushed to an appropriate position. When the tube stent 5 is pushed to an appropriate position, the guide wire 4 and the inner sheath 21 are pulled out, and then the outer sheath 22 is pulled out, whereby the placement of the tube stent 5 is completed.

  When the tube stent 5 is pushed into the stenosis by the outer sheath 22, if it is pushed too far behind the appropriate position, the syringe 35 is operated to be evacuated to expand the balloon 23 and the inner sheath 21. The tube stent 5 is fixed to the inner sheath 21 and the inner sheath 21 and the outer sheath 22 are pulled back to appropriate positions, and then the syringe 35 is operated so as to inhale, the balloon 23 is deflated, and the tube stent 5 is fixed to the inner sheath 21. Is released, the guide wire 4 and the inner sheath 21 are pulled out, and further, the outer sheath 22 is pulled out, whereby the placement of the tube stent 5 can be completed.

  According to the above-described embodiment, the balloon 23 provided on the distal end side of the inner sheath 21 is expanded to be fixed to the inner sheath 21 of the tube stent 5, and conversely, the balloon 23 is contracted, so that the tube The fixation of the stent 5 to the inner sheath 21 can be released. That is, by expanding the balloon 23, the position of the tube stent 5 can be arbitrarily pulled back, and by contracting the balloon 23, the inner sheath 21 is pulled out from the tube stent 5 without moving the position of the tube stent 5. be able to. Therefore, the position adjustment including the position adjustment in the removal direction of the tube stent 5 at the narrowed portion in the bile duct can be easily and reliably performed.

  By the way, in embodiment mentioned above, as FIG.4 and FIG.5 shows, as for the balloon 23, the end surface of the proximal end side of the tube stent 5 contact | abuts to the end surface of the outer end side of the outer sheath 22. In addition, the tube stent 5 is provided on the inner side of the tube stent 5 in a state where the tube stent 5 is disposed on the distal end side of the inner sheath 21. However, the position of the balloon 23 is not limited to this, and as shown in FIG. 8, the end surface on the proximal end side of the tube stent 5 is in contact with the end surface on the distal end side of the outer sheath 22. The tube stent 5 may be provided outside the distal end of the tube stent 5 in a state where the tube stent 5 is disposed on the distal end side of the inner sheath 21. In this case, if the inner sheath 21 is slid in the pulling direction, the tube stent 5 can be pulled back. Conversely, even if the inner sheath 21 is slid in the pushing direction, the position of the tube stent 5 is not affected. You can

  In FIG. 8, the shape of the balloon 23 when expanded is a substantially cylindrical shape. However, as shown in FIG. 9, the balloon 23 has a substantially conical shape whose diameter decreases toward the tip in the expanded state. The balloon 24 can be used. Such a substantially conical shape not only facilitates position adjustment (position adjustment in the pullback direction) of the tube stent 5 but also expands the balloon 24 when the tube stent 5 is inserted into a stenosis or the like. By doing so, the mucosal tissue is scraped by the balloon expanded into a substantially conical shape, so that the tube stent 5 can be smoothly inserted into the stenosis or the like.

  Furthermore, as shown in FIG. 10, in addition to the balloon 23 provided so as to be positioned in the tube stent 5, the substantially conical balloon 24 whose diameter decreases in the expanded state toward the distal end thereof. May be provided. The balloon 23 can facilitate the adjustment of the position of the tube stent 5 (position adjustment in the pull-back direction), and the balloon 24 can improve the insertability of the tube stent 5 into the narrowed portion.

  In this case, intake / exhaust for the balloon 24 is performed using an intake / exhaust system for the balloon 23 (syringe 35, intake / exhaust tube 33, air lumen 32c of the hub 32, air lumen 21b of the inner sheath 21, and intake / exhaust port 21c). However, the air lumen 21b may be further extended to the distal end side to provide an intake / exhaust port that opens into the balloon 24. The air lumen 21b is substantially the same as the intake / exhaust system for the balloon 23. The syringe, the intake / exhaust tube, the air lumen of the hub 32, the air lumen of the inner sheath 21 and the intake / exhaust port are arranged in parallel so that the intake / exhaust to the balloon 23 and the intake / exhaust to the balloon 24 can be performed independently of each other. May be.

  The embodiment described above is described for facilitating understanding of the present invention, and is not described for limiting the present invention. Therefore, each element disclosed in the above-described embodiment is intended to include all design changes and equivalents belonging to the technical scope of the present invention.

DESCRIPTION OF SYMBOLS 1 ... Tube stent delivery apparatus 2 ... Catheter part 21 ... Inner sheath 21a ... Wire lumen 21b ... Air lumen 22 ... Outer sheath 23, 24 ... Balloon 3 ... Operation part 31 ... Connector 32 ... Hub 32b ... Wire lumen 32c ... Air lumen 33 ... Intake and exhaust tube 34 ... Connector 35 ... Syringe 4 ... Guide wire 5 ... Tube stent

Claims (6)

A tube stent delivery device used to place a tube stent in a lumen,
An inner sheath having an air lumen through which air is circulated, the distal end side being inserted into the tube stent, and the tube stent being disposed on the distal end side;
An outer sheath through which the inner sheath is slidably inserted;
A balloon which is provided on a distal end side of the inner sheath, expands when air is supplied to the inside through the air lumen, and contracts when the air is sucked. Tube stent delivery device.   In the state where the tube stent is disposed on the distal end side of the inner sheath such that the end surface on the proximal end side of the tube stent contacts the end surface on the distal end side of the outer sheath, The tube stent delivery device according to claim 1, wherein the tube stent delivery device is provided so as to be located inside the tube stent.   In the state where the tube stent is disposed on the distal end side of the inner sheath such that the end surface on the proximal end side of the tube stent contacts the end surface on the distal end side of the outer sheath, The tube stent delivery device according to claim 1, wherein the tube stent delivery device is provided so as to be located outside a distal end of the tube stent.   The tube stent delivery device according to claim 3, wherein the balloon has a substantially conical shape whose diameter decreases in the expanded state toward the tip. The balloon is a first balloon, the air lumen is a first air lumen, and is provided on the distal end side of the inner sheath with respect to the first balloon. A second balloon that expands when air is supplied to the inside thereof through a second air lumen formed in the air lumen and contracts when the air is sucked;
The tube stent is disposed on the distal end side of the inner sheath such that the end surface on the proximal end side of the tube stent contacts the end surface on the distal end side of the outer sheath. The tube stent delivery device according to claim 2, wherein the tube stent delivery device is provided so as to be located outside a distal end of the tube stent.   The tube stent delivery device according to claim 5, wherein the second balloon has a substantially conical shape whose diameter decreases in a dilated state toward the distal end.

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