JPH0464367A - Expander for vital duct - Google Patents

Abstract

PURPOSE:To prevent possible damages to a biotissue in a vital duct or to pre vent possible damages to the internal surface of a channel of an endoscope in the insertion of an expander through the channel thereof by providing a protective member mounted on a balloon dilator when the expander is inserted into the vital duct. CONSTITUTION:A stent 1 reduced and an easy to break member (protective member) 6 are mounted tight on the outer circumference of a balloon 4. Then, the vicinity of the balloon 4 reduced is positioned in a constricted part 8 of a vital pipeline 7. Then, a fluid such as air or water is injected into the balloon 4 through a catheter 5 to expand the balloon 4. With the expansion of the balloon 4, the stent 1 mounted on the circumferential surface of the balloon 4 is broadened to press the constricted part 8 of the vital pipeline 7 stretched out. Here, the easy to break member 6 on the outer circumference of the stent 1 is broken into pieces by the stretching action of the stent associated 1 with the expansion of the balloon 4.

Description

[Detailed Description of the Invention] [Industrial Application Fields] The present invention dilates strictures occurring in biological ducts such as blood vessels, esophagus, bile ducts, pancreatic ducts, urethra, and ureters, and The present invention relates to a device for dilating biological ducts that is placed in order to secure a cavity.

[Prior Art] This type of biological duct expander is known, for example, as disclosed in Japanese Patent Application Laid-open No. 62
-231657 publication or JP-A-63-2142
The one shown in Japanese Patent No. 64 is known. Specifically, for the treatment of narrowed blood vessels and enlarged prostates, a stent with multiple holes is attached to a mesh-like or tubular vibrator on a balloon dilator, and the stent is inserted into a blood vessel or urethra. Expand the balloon dilator. As a result, the stent is also expanded at the same time, and after the stent is expanded, the balloon dilator is removed and only the expanded stent is left in the body to secure the lumen of the blood vessel or urethra.

[Problems to be Solved by the Invention] However, in the conventional biological duct expander,
For example, a mesh type stent is made of a wire such as stainless steel or titanium, and a stent in which a large number of holes are formed in a tubular vibrator is made of a hard member such as a stainless steel vibrator.

Therefore, both ends of the stent have sharp hard edges.

Therefore, when inserting this stent into a biological duct such as a blood vessel, bile duct, or urethra, or when indwelling the stent in a duct, the biological tissue may be torn or perforated by both ends of the stent, causing damage to the biological tissue. There was a risk that he might.

Furthermore, when using a stent to treat bile duct stricture, for example, the stent is inserted through the channel of the endoscope, but the sharp and hard edges of the stent may damage the inside of the channel of the endoscope. Another problem is that both end edges of the stent get caught on the forceps lift of the endoscope, making it difficult to insert the stent endoscopically.

The present invention has been made in view of the above-mentioned problems, and its purpose is to provide a device with a relatively simple structure that can be used in a living body when inserted into a biological duct or when indwelled in a biological duct. It is an object of the present invention to provide a device for dilating biological ducts that does not cause damage to tissues or endoscopes.

[Means for Solving the Problems and Their Effects] In order to solve the above problems, the present invention provides a balloon dilator that is mounted on a balloon dilator when inserted into a biological duct, and is expanded by the expansion of the balloon dilator into a biological stenosis. In the dilating device for a living body duct to be indwelled, a protective member is provided on at least a part of the outer surface of the dilating device mounted on the balloon dilator to prevent damage to living tissue by the dilating device. .

Accordingly, the above-mentioned protective member prevents damage to the biological tissue in the biological duct by providing the protective member to be mounted on the balloon dilator when inserting the dilator into the biological duct, Alternatively, when inserted through a channel of an endoscope, avoid damaging the inner surface of the channel.

Embodiment FIGS. 1 to 5 show a first embodiment of the present invention.

The stent 1 shown in FIG. 1 is constructed into a cylindrical shape by knitting wires made of materials such as stainless steel or titanium into a mesh shape, and the wires are arranged at both ends 2 to prevent them from dispersing. The contact points or intersections are fixed by spot welding, bonding with a biocompatible adhesive, or the like.

Further, FIG. 2 shows the overall configuration of the device equipped with the dilator consisting of the stent 1. The balloon dilator 3 includes a balloon 4 made of an elastic material and a catheter 5 for supplying fluid.

Then, the stent 1 is fitted onto the outer periphery of the balloon 4 of the balloon dilator 3.

Moreover, on the outer periphery of the stent 1 installed on the balloon 4, when inserting the expander into the biological conduit 7,
A cylindrical easily broken member (protective member) to prevent damage to living tissue such as tearing or perforation, and to protect the inner surface of the endoscope channel when inserting a dilator endoscopically. 6
is provided. This easily broken member 6 is the stent 1
It is formed longer than the length of the stent unit so as to cover the entire outer periphery of the stent 1 and to completely cover and wrap both ends 2 of the stent 1. The material of the easily destructible member 6 is, for example, vinyl chloride, polyethylene, polyethylene terephthalate, etc., and is formed so as to be easily destroyed by the expansion force when the balloon 4 of the balloon dilator 3 is inflated, and has a thickness of several μm, for example. It is made of thin film material.

Both front and rear ends 6a, 6b of the easily destructible member 6 are fixed to the circumferential surface of the balloon 4 by weak adhesive so as not to separate from the balloon dilator 3 when inserted into the biological conduit 7.

Next, the operation when using the extension device with this configuration will be explained.

First, as shown in FIG. 3, the balloon 4 is deflated in advance, and the deflated stent 1 and the breakable member 6 are attached to the outer periphery of the balloon 4 in close contact with each other.

Then, the dilator equipped with the stent 1 and the breakable member 6 is inserted into the biological conduit 7 such as a blood vessel, esophagus, bile duct, pancreatic duct, urethra, or ureter through a channel of an endoscope or the like.

Then, the vicinity of the deflated balloon 4 is positioned within the constricted portion 8 of the biological conduit 7, as shown in FIG.

Next, as shown in FIG. 4, fluid such as air or water is injected into the balloon 4 through the catheter 5 to inflate the balloon 4. As the balloon 4 expands, the stent 1 mounted on the circumferential surface of the balloon 4 expands, compressing the narrowed portion 8 of the biological duct 7 and expanding it. At this time, since the breakable member 6 on the outer circumference of the stent 1 is formed of a thin film member with a thickness of several micrometers and is easily broken, as described above, the stent 1 as the balloon 4 expands.
As a result of the expansion action, as shown in FIG. 4, it is broken into small pieces.

After this rupture state, the fluid such as air and water injected into the balloon 4 is discharged, and the balloon 4 is deflated. Then,
The stent 1 remains expanded within the biological duct 7, and only the balloon 4 is deflated. Then, as shown by the arrow in FIG. 5, the catheter 5 and the balloon 4 are removed from the biological conduit 7.

As a result, only the stent 1 can be placed in the narrowed portion 8 of the biological channel 7, and the narrowed portion 8 can be maintained in an expanded state.

According to the dilator configured in this way, since the easily broken member 6 as a protective member is provided on the outer circumference of the stent 1 mounted on the outer peripheral surface of the balloon 4, the dilator can be inserted into the biological conduit 7. During insertion, there is no risk of tearing living tissue with the end edge 2 of the stent 1 or damaging the inner surface of the channel of the endoscope.

Further, the easily destructible member 6 is formed of a thin film member, and when subjected to the expansion action of the stent 1 due to the expansion of the balloon 4,
easily destroyed. The stent 1 can then be reliably placed in the constricted portion 8 of the biological duct 7.

FIGS. 6 and 7 show a second embodiment of a dilator according to the present invention. Also in this embodiment, the balloon 4 of the balloon dilator 3 is used as described in the first embodiment.
A mesh-like stent 1 is fitted onto the outer periphery of the stent. In addition, on the outer periphery of both end edges of the mesh-like stent 1 mounted on the outer circumferential surface of the balloon 4, there are provided a structure for protecting the inner surface of the biological conduit 7 and the channel of the endoscope, as described in the first embodiment. A thin film-like easily breakable member (protective member) 9 is attached to the stent 1 so as to cover the sharp parts at both end edges thereof.

In addition, each of the easily destructible members 9 has notches along the axial direction of the balloon dilator 3 whose wall thickness is relatively thinner than the surroundings in order to improve the destructibility when the stent 1 expands due to the expansion of the balloon 4. Section 10 is provided. moreover,
The easily destructible member 9 is fixed to the balloon 4 by adhesive so that it does not separate from the balloon dilator 3 when inserted into the biological conduit 7.

To use the dilator configured in this manner, the dilator is inserted into the biological channel 7 through the channel of the endoscope, etc., as in the first embodiment described above. Then, the balloon 4 is positioned at the stenosis 8. Next, fluid such as air or water is injected into the balloon 4 via the catheter 5 to inflate the balloon 4. As the balloon 4 expands, the stent 1 mounted on the circumferential surface of the balloon 4 expands, compressing the stenosis 8 and expanding it. At this time, the breakable members 9 provided on the outer periphery of both end edges of the stent are formed of a thin film member as described in the first embodiment, and in this embodiment, especially the axis of the balloon dilator 3. Since the notches 10 are provided along the direction, the stent 1 is broken into pieces along the notches 10 by the expansion action of the stent 1 as the balloon 4 expands.

Then, when the fluid such as air and water injected into the balloon 4 is discharged and the balloon 4 is deflated, the stent 1 remains expanded within the constricted part 8 of the biological conduit 7, and only the balloon 4 is deflated. . Then, the catheter 5 is removed together with the balloon 4. Thereby, only the stent 1 can be placed in the expanded state in the constricted portion 8 within the biological duct 7.

According to the expander configured in this way, the easily destroyed members 9 are formed on the outer periphery of both end edges of the stent 1 attached to the balloon 4, which is easily destroyed by the expanding action of the stent 1 as the balloon 4 expands. Because this easily breakable member 9 is provided, it plays the role of a protective member, and when inserting the expander into the biological duct 7, the both end edges 2 of the stent 1 may tear the living tissue or cause endoscopic vision. There is no risk of damaging the inner surface of the mirror channel.

In addition, since the easily broken member 9 is provided with a notch 10,
It can be destroyed more easily than that of the first embodiment.

Further, since the easily destructible member 9 is provided only at both end edges of the stent 1, the amount of broken pieces of the easily destructible member 9 remaining in the biological conduit 7 after the balloon 4 is destroyed when inflated is minimized.

FIGS. 8 to 11 show a biological channel dilator according to a third embodiment of the present invention. In this embodiment as well, the first
As described in the above embodiment and the second embodiment, the mesh-shaped stent 1 is fitted onto the outer periphery of the balloon 4 of the balloon dilator 3. Moreover, on the outer periphery of the mesh-like stent 1 attached to the circumferential surface of the balloon 4,
Biological conduit 7, for protecting the inner surface of the endoscope channel,
The easily broken member 11 as described in the first embodiment and the second embodiment is provided to cover the entire stent 1, and also covers the catheter 5 on the rear end side of the balloon dilator 3. are doing.

This easily destructible member 11 has a perforation-like fracture portion 12 along the axial direction of the balloon dilator 3 in order to improve the destructibility when the stent 1 expands due to the expansion of the balloon 4.
This is provided.

The easily destructible member 11 is fixed to the balloon 4 by weak adhesive so that the distal end side of the balloon dilator 3 does not come off from the balloon dilator 3 when inserted into the biological conduit 7, and is fixed to the balloon dilator 3 by weak adhesive. The end side is relatively strongly adhesively fixed to the catheter 5 in order to recover the easily broken member 11 when the balloon dilator 3 is removed.

The dilator configured in this manner is inserted into the biological conduit 7 and positioned at the constricted portion 8, as in the first and second embodiments described above. Then, when a fluid such as air or water is injected into the balloon 4 and the balloon 4 is inflated, the stent l attached to the circumferential surface of the balloon 4 expands and compresses the stenosis 8, as shown in FIG. and expand. At this time, the easily broken member 11 provided on the outer periphery of the stent 1 is
Since the balloon dilator 3 is provided with a perforated break section 12 along the axial direction, the stent 1 is broken into strips by the expansion action of the stent 1 as the balloon 4 expands.

Next, as shown in FIG. 11, when the fluid such as air and water injected into the balloon 4 is discharged and the balloon 4 is deflated, the stent 1 remains in an expanded state within the biological conduit 7, leaving only the balloon 4. is contracted. Then, when the catheter 5 is removed together with the balloon 4, as shown in FIG.
It will be collected at the same time as it is removed. Then, only the stent 1 is expanded and placed in the constricted portion 8 within the biological duct 7.

Thus, the dilator configured in this manner has an easily broken member 11 having a perforated breakage portion 12 as a protective member on the outer circumferential surface of the stent 1 mounted on the outer circumference of the balloon 4. Therefore, when inserting the dilator into the living body channel 7, there is no risk of cutting the living tissue with the sharp ends of the stent 1 or damaging the inner surface of the channel of the endoscope. In addition, the rear end side of the balloon dilator 3 of the easily broken member 11 is relatively strongly adhesively fixed to the catheter 5 so that it can be recovered at the same time as the balloon dilator 3 is removed. No broken pieces of the easily broken member 11 remain.

FIGS. 12 and 13 show a biological channel dilator according to a fourth embodiment of the present invention. In this embodiment as well, a mesh-like stent 1 is fitted over the outer periphery of the balloon 4 of the balloon dilator 3, as in the first, second, and third embodiments. . Further, on the outer periphery of the stent 1, a biodegradable and absorbable member 13 is placed on the entire stent 1 as an easily broken member (protective member) for protecting the inner surface of the biological conduit 7 and the channel of the endoscope. It is provided in such a way that it covers the As the biodegradable absorbable member 13, for example, chitin, collagen, polylactic acid, etc. are used.

The dilator configured in this manner is inserted into the biological duct 7 and positioned at the constricted portion 8, as in the first embodiment. Then, when a fluid such as air or water is injected into the balloon 4 to inflate the balloon 4, the stent 1 mounted on the balloon 4 expands and the stenotic portion 8 is expanded. At this time, the biodegradable and absorbable member 13 as an easily broken member provided on the outer periphery of the stent 1 is broken into pieces as in the first embodiment. Then, when the air, water, and other fluids in the balloon 4 are discharged, and the balloon 4 is deflated and removed, only the stent 1 is left in the living body duct 7 with the constricted portion 8 expanded.

The finely broken biodegradable absorbable member 13 is made of chitin,
Since it is made of a material such as collagen that is decomposed and absorbed in the living body, it will eventually be decomposed and absorbed in the living body, and no broken pieces will remain in the living body conduit 7.

Since the dilator constructed in this way covers the entire stent 1 with the biodegradable and absorbable member 13 as in the fourth embodiment, it does not damage the living tissue or the inner surface of the channel of the endoscope. Since biodegradable and absorbable materials such as chitin, collagen, etc. are used, no fragments that become foreign substances remain in the biological conduit 7.

In addition to the above-mentioned chitin, collagen, and polylactic acid, the bioabsorbable member 13 may also include bile-soluble materials such as bile acid derivatives and fatty acid membranes when a dilator is applied to bile duct strictures. A similar effect can be obtained by using different materials.

14 to 17 show a dilator showing a fifth embodiment of the present invention. As described in the first to fourth embodiments, the mesh-shaped stent 1 is fitted onto the outer periphery of the balloon 4 of the balloon dilator 3.

On the outer circumferential surface of both ends of the stent 1 mounted on the balloon 4, when inserting the expander into the biological conduit 7, there are protective measures to prevent damage to the biological tissue such as tearing or perforation, or Easily peelable members 14 are provided to cover the sharp parts of both end edges of the stent 1 to protect the inner surface of the channel of the endoscope when inserting the dilator endoscopically.

As the easily peelable member 14, for example, adhesive silicone resin, polyurethane resin, or the like is used. The easily peelable member 14 does not peel off from the balloon 4 when inserted into the biological duct 7, but easily peels off from the surface of the balloon 4 when the balloon dilator 3 is deflated and removed after expanding the balloon 4 and stent 1. It is adhesively fixed to the balloon 4 with a certain degree of strength.

To use the dilator configured in this way, as shown in FIG. let Next, as shown in FIG. 16, fluid such as air or water is injected into the balloon 4 via the catheter 5 to inflate the balloon 4. As balloon 4 expands, balloon 4
The stent 1 attached above expands and compresses the stenosis 8 to expand it.

At this time, the easily peelable members 14 provided on the outer periphery of both end edges of the stent 1 are removed by the expansion of the balloon 4 and the stent 1.
It is peeled off from the surface of the balloon 4.

Next, the fluid such as air and water injected into the balloon 4 is discharged and the balloon 4 is deflated as shown in FIG.
The stent 1 remains expanded within the biological duct 7, and only the balloon 4 is deflated. And balloon dilator 3
is removed in the direction shown by the arrow in FIG.

The expander configured in this way has easy-to-peel members on the outer periphery of both end edges of the stent 1 mounted on the balloon 4, which are easily peeled off from the surface of the balloon 4 due to the expanding action of the stent 1 as the balloon 4 expands. 14, this plays the role of a protective member, and furthermore, when inserting the dilator into the biological channel 7, the sharp parts at both ends of the stent 1 may tear the biological tissue or damage the channel of the endoscope. There is no risk of damage to the inner surface.

18 to 22 show a dilator according to a sixth embodiment of the present invention. A mesh-like stent 1 is fitted onto the outer periphery of the balloon 4 of the balloon dilator 3. On the outer periphery of the stent 1 mounted on the balloon 4, when inserting the dilator into the biological channel 7, as in the first to fifth embodiments described above, there are The first step is to prevent damage to the inner surface.
An expandable and easily peelable member 15 as a protection member shown in FIG. 8 is provided to cover the entire stent 1 as shown in FIG. 19. As the expandable and easily peelable member 15, for example, a thin film of polyethylene or the like is used. and,
The expandable and easily peelable member 15 has a bellows cylindrical shape, as shown in FIG. 18, so that it expands simultaneously when the stent 1 expands with the expansion of the balloon 4. Both ends 16 of the expandable and easily peelable member 15 are not peeled off from the balloon 4 when inserted into the biological conduit 7;
and after expanding stent 1, balloon dilator 3
It is adhesively fixed to the balloon 4 with such strength that it can be easily peeled off from the surface of the balloon 4 when it is deflated and removed.

To use the dilator configured in this way, the dilator is inserted into the biological conduit 7 through the treatment channel of an endoscope, and the balloon 4 is inserted into the stenosis 8, as shown in FIG. position. Next, as shown in FIG. 21, fluid such as air or water is injected into the balloon 4 via the catheter 5 to inflate the balloon 4. When the balloon 4 is inflated, the stent 1 mounted on the outer periphery of the moni balloon 4 expands, compressing the stenotic region 8 and expanding it. At this time, stent 1
Since both ends 16 of the expandable and easily peelable member unit 5 provided on the outer circumference of the balloon 4 are fixed to the balloon 4 by weak adhesive, they are peeled off from the surface of the balloon 4 when the balloon 4 and the stent 1 are expanded, and the expandable and easily peelable member unit 5 is easily peeled off. The bellows portion of the peeling member 15 stretches and expands together with the stent 1.

Next, when the fluid such as air or water injected into the balloon 4 is discharged, the balloon 4 is deflated as shown in FIG.
It remains expanded inside.

Then, the balloon dilator 3 is pulled toward the proximal side as indicated by the arrow in FIG. 22 and removed.

In the expander constructed in this manner, both ends 16 of the expander are easily peeled off from the surface of the balloon 4 due to the expansion action of the stent 1 accompanying the expansion of the balloon 4, and the bellows are expanded as the stent 1 is expanded. Since the expandable and easily peelable member 15 is provided on the outer periphery of the stent 1, there is no risk of damaging the living tissue or the inner surface of the endoscope channel, as in the fifth embodiment described above.

Furthermore, in the configuration of this embodiment, the expandable and easily peelable member 15 is provided on the entire outer periphery of the stent 1;
As in the fifth embodiment, the sharp portions may be provided only at both ends of the stent 1.

FIGS. 23 to 27 show an extension device according to a seventh embodiment of the present invention. A mesh-like stent 1 is fitted onto the outer periphery of the balloon 4 of the balloon dilator 3. Further, on the outer periphery of the stent 1, as in the embodiment described above, in order to prevent damage to the living tissue or the inner surface of the channel of the endoscope when the dilator is inserted into the living body channel 7, there are provided marks. An expandable and easily peelable member 17 as a protective member shown in FIG. 23 is provided to cover the entire stent 1 as shown in FIG. 24. This expandable and easily peelable member 17
For example, a thin film of polyethylene or the like is used, and holes 18 are provided around the cylinder so that the stent 1 expands at the same time as the balloon 4 expands.

Both cylindrical ends 19 of the expandable and easily peelable member 17 do not separate from the balloon dilator 3 when inserted into the biological duct 7, but when the balloon dilator 3 is deflated and removed after the stent 1 is indwelling, the balloon dilator 3 It is fixed to the balloon 4 by weak adhesive so that it can be easily peeled off from the balloon. Furthermore, a fixing band 20 is provided at one end of the expandable and easily peelable member 17 so that the expandable and easily peelable member 17 can be retrieved at the same time as the balloon dilator 3 after the stent 1 is indwelled. It is strongly adhesively fixed.

To use the dilator constructed in this manner, the dilator is inserted into the biological conduit 7 through the channel of the endoscope, and the balloon 4 is positioned in the constricted portion 8, as shown in FIG. Next, as shown in FIG. 26, fluid such as air or water is injected into the balloon 4 through the catheter 5 to inflate the balloon 4. As the balloon 4 expands, the stent 1 mounted on the outer periphery of the balloon 4 expands, compressing the stenotic region 8 and expanding it. At this time, both cylindrical ends 19 of the expandable and easily peelable member 17 provided on the outer periphery of the stent 1 are easily peeled off because they are fixed to the balloon 4 by weak adhesion. Furthermore, since the expandable and easily peelable member 17 has a hole 18 provided around the cylindrical periphery, it is expanded together with the stent 1.

Next, when the fluid such as air or water injected into the balloon 4 is discharged, the balloon 4 is deflated as shown in FIG. 27. Then, when the catheter 5 is removed together with the balloon 4, the fixing band 20 of the expandable and easily peelable member 17 is relatively strongly adhesively fixed to the catheter 5, as shown in FIG. be done. Then, only the stent 1 is expanded and placed in the constricted portion 8 within the biological duct 7.

The dilator configured in this manner has holes 18 as protective members on the outer periphery of the stent 1 mounted on the outer periphery of the balloon 4.
Since the cylindrical expandable and easily peelable member 17 is provided, when the expander is inserted into the biological channel 7, the sharp ends of the stent 1, etc. may tear the biological tissue, or the endoscope may be damaged. There is no risk of damaging the inner surface of the channel.

In addition, the rear end side of the balloon dilator 3 of the expandable and easily peelable member 17 is strongly adhesively fixed to the catheter 5 so that it can be recovered at the same time as the balloon dilator 3 is removed. No easily peelable member 17 remains.

FIGS. 28 to 32 show an eighth embodiment of the dilator of the present invention. On the outer periphery of the balloon 4 of the balloon dilator 3, a mesh-like stent 1 is fitted and attached as in the previous embodiment. In addition, on both ends of the stent 1, there are provided seals, as shown in FIG. As shown in , a ring-shaped heat softening member 21 is provided as a protective member to cover the sharp portions at both ends of the stent 1 and is fixed on the outer periphery of both ends of the stent 1 . As the heat softening member 21, a thermoplastic resin such as polyurethane thermoplastic elastomer is used, for example. The thermoplastic resin is relatively hard in a low temperature range, but when heated, it undergoes plastic deformation and becomes soft.

To use the dilator configured in this way, the balloon dilator 3 equipped with the dilator is inserted into the biological conduit 7 through the channel of an endoscope, for example, as shown in FIG. Position it at 8. Next, the 31st
As shown in the figure, warm water at a temperature of about 40 to 60° C., which is slightly higher than body temperature, is injected into the balloon 4 through the catheter 5 to inflate the balloon 4. By inflating the balloon 4 in this manner, the stent 1 expands and compresses the stenosis 8 to expand. At this time, since the heat softening members 21 provided on the outer periphery of both ends of the stent 1 are made of thermoplastic resin, they are heated and softened by hot water injected into the balloon 4. Then, along with the expansion of the stent 1 due to the expansion of the balloon 4, the stent itself expands.

Next, when the hot water injected into the balloon 4 is discharged, the balloon 4 contracts as shown in FIG. 32, and the stent 1 and the heat-softening member 21 remain in an expanded state within the biological conduit 7. The balloon dilator 3 is removed by pulling it toward the proximal side as indicated by the arrow in FIG.

The expander configured in this manner has thermo-softening members 21 made of thermoplastic resin on the outer periphery of both ends of the stent 1, which are softened by hot water injection into the balloon 4 and expand together with the stent 1. As in the case of the embodiment, there is no risk of damaging the living tissue or the inner surface of the channel of the endoscope.

In this embodiment, the heat softening member 21 is formed into a ring shape and is provided on the outer periphery of both ends of the stent 1.
As shown in FIG. 34, it may be made into a cap shape and fixed on the outer periphery of both ends of the stent 1. Further, it may be provided not only at both ends of the stent 1 but also over the entire stent.

What is shown in FIGS. 35 to 41 is a dilator showing a ninth embodiment of the present invention. FIG. 35 shows a balloon dilator used in this embodiment, and the balloon 22 is provided at the tip of a fluid supply catheter 23. The proximal end of the catheter 23 is connected via a branch 24 to an outlet tube 25a of the water injection conduit and an outlet tube 25b of the drainage conduit. And each of the lead-out tubes 25a.

25b is connected to a fluid source (not shown), and heated or cooled fluid from the fluid source can be supplied to and discharged from the balloon 22 through the catheter 23. Further, on the distal end side of the catheter 23 to which the balloon 22 is attached, there is an injection hole 26 which communicates with the water injection pipe and the discharge pipe, respectively, as shown in FIG.
A discharge hole 27 is formed and communicates with the inside of the balloon 22.

On the outer periphery of the balloon 22, as shown in FIG. 38, the mesh-shaped stent 1 described above is fitted and attached. In addition, on the outer periphery of both ends of the stent 1 attached on the outer periphery of the balloon 22, when the dilator is inserted into the biological channel 7, the living tissue and the inner surface of the channel of the endoscope are prevented from being damaged. A thermal expansion member 28 as a protection member shown in FIG. 37 is provided to cover the outer periphery of both ends of the stent 1 as shown in FIG. 38, and is fixed to the outer periphery of both ends of the stent 1. There is. The material of the thermal expansion member 28 is made of shape memory resin, and is set to recover to the large diameter shape shown in FIG. 40 at a predetermined temperature or higher. Examples of the material include polynorbornene, trans-1,4-polyisoprene, styrene-butadiene copolymer, and polyurethane. This material is in a rubber state above a predetermined shape recovery temperature and recovers its shape while softening. Below the shape recovery temperature, it remains in a plastic state and hardens. In addition, the shape recovery temperature mentioned above is 40
Set between ℃ and 60℃.

To use the dilator configured in this manner, the dilator is inserted into the biological channel 7 through the channel of the endoscope, and the balloon 4 is positioned in the constricted portion 8, as shown in FIG. Next, hot water at a temperature higher than the shape recovery temperature is injected into the balloon 22 from the water injection pipe, and is sequentially discharged from the drainage pipe to perform hot water perfusion. As a result, the balloon 22 engraves and the stent 1 expands to compress the stenosis 8 and dilate it. At this time, the thermal expansion member 28 provided on the outer periphery of both ends of the stent 1 increases in temperature due to heat transfer from the hot water via the balloon 22, softens and begins to recover its memorized shape, and expands together with the stent 1. do.

Next, cold water at a temperature below the shape recovery temperature is perfused into the balloon 22 instead of the hot water. As a result, the thermal expansion member 28
is cooled and hardened, maintaining the shape shown in FIG.

Thereafter, as shown in FIG. 41, when the balloon 22 is deflated, the stent 1 and the thermal expansion member 28 are
It remains expanded inside.

Then, the balloon dilator is removed in the direction indicated by the arrow in FIG. 41 toward the proximal side.

The expander configured in this manner is softened by injecting hot water into the balloon 22 and expands together with the stent 1, and is expanded and cooled and hardened by injecting cold water into the balloon 22.

Since the thermal expansion member 28 is provided on the outer periphery of both ends of the stent 1, there is no risk of damaging the living tissue or the inner surface of the channel of the endoscope, as in the eighth embodiment described above.

In this embodiment, hot water was injected into the balloon 22 as a heating means for the thermal expansion member 28, but a nichrome wire 29 was provided inside the balloon 22 as shown in FIG. A planar heating element 30 may be provided to electrically heat the heating element.

FIGS. 44 to 48 show a dilator representing a tenth embodiment of the present invention. A mesh-like stent 1 is fitted onto the outer periphery of the balloon 4 of the balloon dilator 3, as in the previous embodiment.

The mesh-like stent 1 is formed by braiding wires made of stainless steel, titanium, etc., and both ends 2 are spot-welded.
Although the stent 1 is fixed by adhesion with biocompatible adhesive, etc., the mutual intersection points of other wires are not fixed, so when the stent 1 is expanded in the radial direction, it contracts in the axial direction. has.

Further, on the outer periphery of both ends 2 of the stent 1, in order to prevent tearing of the living tissue and damage to the inner surface of the channel of the endoscope when inserting the dilator into the living body channel 7,
A cap-shaped protective member 31 shown in FIG. 44 is attached to the stent 1.
It is provided in such a way as to cover the sharp parts at both ends 2 of.

As the protection member 31, a heat shrink tube is used, for example, and the catheter side end 32 of the protection member 31 is connected to the fourth
As shown in FIG. 5, the balloon dilator 3 is tightly fixed to the catheter 5 due to the thermal contraction effect of the protective member 31, but the balloon side end 33 is tightly fixed to the catheter 5 of the stent 1.
It is provided with a space 34 so that it does not come into contact with.

To use the dilator configured in this way, the dilator is inserted into the biological conduit 7 through the channel of an endoscope, for example, as shown in FIG.
position.

Next, as shown in FIG. 47, fluid such as air or water is injected into the balloon 4 via the catheter 5 to inflate the balloon 4. The stent 1 expands in the radial direction by the expansion of the balloon 4, or at this time, the stent 1 contracts in the axial direction as described above, and as shown in FIG. It will come off from the balloon side end 33. Next, when the air, water, and other fluids injected into the balloon 4 are discharged, the balloon 4 appears as shown in FIG.
is contracted, and the stent 1 remains in an expanded state within the biological duct 7. Then, the balloon dilator 3 is removed in the direction shown by the arrow in FIG.

The expander configured in this manner has a protective member 31 on the outer periphery of both ends 2 of the stent 1 mounted on the balloon 4, and utilizes the axial contraction effect caused by the radial expansion of the mesh-like stent 1. The narrowing part 8 that occurs in the biological duct 7 due to
When inserting the expansion device into the biological channel 7,
There is no risk that the sharp ends 2 of the stent 1 will tear the living tissue or damage the inner surface of the channel of the endoscope.

In each of the first to tenth embodiments, the stent was made of stainless steel, titanium, etc. wire woven into a mesh shape as shown in FIG. There are various types of stents, such as a stent 1 having a metal vibrator with many holes as shown in the figure, a coiled stent 1 as shown in FIG. can be used.

Note that the zigzag-shaped stent 36 shown in FIG.
When the balloon 4 expands, the zigzag portion of the stent 36 expands, expanding the diameter as a whole and dilating the stenotic region 8. The balloon dilator used for this stent 36 is It is preferable to use those shown in FIGS.

That is, the balloon dilator 37 shown in FIG. 52 is provided with protrusions 39a and 39b at both the front and rear ends of the balloon 38, which protrude from the wall thickness of the balloon 38, respectively.

The method of use is to lock the loops 35 at both ends of the zigzag-shaped stent 36 to the protrusions 39a and 39b, respectively, as shown in FIG. Then, when a fluid such as air or water is injected into the balloon 38 through the catheter 40, the loops 35 at both ends of the stent 36 are inserted into the protrusions 39a, 39b.
Since the stent 36 is locked by the stent, the zigzag portion easily expands as shown in FIG. 53, and the overall diameter of the stent 36 increases.

Further, the balloon dilator 41 shown in FIG. 54 has protrusions 39a provided at both the front and rear ends of the balloon.

39b can be protruded separately.

That is, a partition 42 is provided inside the balloon 38 in order to project the protrusion 39a on the front side of the balloon 38, and by inserting the first catheter 43, only the portion surrounded by this partition 42 can be freely inflated and deflated. This is how it was done.

Similarly, a partition 44 and a second catheter 45 are provided on the balloon rear protrusion 39b so that only the portion surrounded by the partition 44 can be freely inflated and deflated. Further, the third catheter 46 is provided so that the intermediate portion of the balloon 38 can be freely inflated and deflated. In this way, by freely controlling the expansion and contraction of the balloon front protrusion 39a, rear protrusion 39b1, and balloon intermediate portion, the zigzag portion of the zigzag-shaped stent 36 can be expanded more reliably, and the stenotic region can be expanded. 8 can be easily expanded.

On the other hand, in order to lock the loops 35 at both ends of the stent 36, projections 39a are provided at both the front and rear ends of the balloon.

39b does not use the thick part of the balloon 38, but as shown in FIG. 55, the rigid body part 47a,
47b may be fixed by adhesive.

Further, the shape of the zigzag portion of the zigzag stent 36 may be as shown in FIGS. 56 and 57,
With this shape, the stent 36 can be expanded more easily.

[Effects of the Invention] As explained above, according to the present invention, the end of the dilator does not tear or perforate the living tissue, and the dilator can be passed through the channel of the endoscope. There is no risk of damaging the inner surface of the channel of the endoscope during insertion.

[Brief explanation of the drawing]

1 to 5 show a first embodiment of the present invention, FIG. 1 is a side view of the stent, FIG. 2 is a side view of the dilator for biological ducts, and FIG. 3 is a side view of the stent. 4 is a cross-sectional view of the dilator and stent during expansion operation, and FIG. 5 is a sectional view of the dilator being removed from the biological duct after the dilation operation. FIG. FIGS. 6 and 7 show a second embodiment of the present invention, and FIG. 6 is a side view of a biological channel dilator equipped with a stent;
FIG. 7 is a longitudinal sectional view thereof. 8 to 11 show a third embodiment of the present invention,
Fig. 8 is a side view of the dilator for biological ducts equipped with a stent, Fig. 9 is a longitudinal sectional view thereof, Fig. 10 is a sectional view of the dilator and stent during expansion operation, and Fig. 11 is the dilator. FIG. 3 is a cross-sectional view showing a state when the dilator is removed from the biological duct after the dilation operation. FIGS. 12 and 13 show a fourth embodiment of the present invention, in which FIG. 12 is a side view of a biological channel dilator equipped with a stent, and FIG. 13 is a longitudinal sectional view thereof. Figures 14 to 17 show a fifth embodiment of the present invention, in which Figure 14 is a side view of a biological duct dilator fitted with a stent inserted into a biological duct, and Figure 16 is 17 is a cross-sectional view of the dilator and the stent during the expansion operation, and FIG. 17 is a cross-sectional view showing the state when the dilator is removed from the biological duct after the expansion operation of the dilator. 18 to 22 show a sixth embodiment of the present invention, in which FIG. 18 is a perspective view of the expandable and easily peelable member, and FIG. 19 is a perspective view of the expandable and easily peelable member, and FIG. FIG. 20 is a perspective view of the state in which the peeling member is attached; FIG.
The figure shows a cross-sectional view of the dilator and stent during its expansion operation.
FIG. 22 is a sectional view showing a state when the dilating device is removed from the biological channel after the dilating operation of the dilating device. 23 to 27 show a seventh embodiment of the present invention, FIG. 23 is a perspective view of the stent, FIG. 24 is a perspective view of the stent attached to the biological duct dilator, Fig. 25 is a cross-sectional view of a biological conduit dilator fitted with a stent inserted into a biological conduit, Fig. 26 is a cross-sectional view of the dilator and stent during its expansion operation, and Fig. 27 is its expansion. FIG. 7 is a cross-sectional view showing a state when the expansion device is removed from the biological channel after the expansion operation of the device. 28 to 32 show an eighth embodiment of the present invention, FIG. 28 is a perspective view of the heat-softening member, and FIG. 29 is a side view of the biological duct dilator with the stent attached. figure,
Fig. 30 is a cross-sectional view of a biological conduit dilator fitted with a stent inserted into a biological conduit, Fig. 31 is a cross-sectional view of the dilator and stent during its expansion operation, and Fig. 32 is its expansion. FIG. 7 is a cross-sectional view showing a state when the expansion device is removed from the biological channel after the expansion operation of the device. FIG. 33 is a perspective view showing a modified example of the heat-softening member, and FIG. 34 is a perspective view of the heat-softening member attached to the expansion device. 35 to 41 show a ninth embodiment of the present invention, in which FIG. 35 is a side view of the expander for biological conduits, FIG. 36 is a sectional view thereof, and FIG. 37 is a thermal expansion member. A perspective view of
FIG. 38 is a side view of the expansion tool with the thermal expansion member attached;
Fig. 39 is a side view of the dilator inserted into the biological duct, Fig. 40 is an explanatory diagram of its expansion operation, and Fig. 41 is an explanatory diagram showing the state when the dilator is removed from the biological duct. It is. FIGS. 42 and 43 are cross-sectional views of a dilator showing a modified example. 44 to 48 show a tenth embodiment of the present invention, FIG. 44 is a perspective view of the protection member, FIG. 45 is a cross-sectional view of the biological channel dilator, and FIG. 46 is its expansion. FIG. 47 is an explanatory diagram of the device being inserted into the biological duct, FIG. 47 is an explanatory diagram of the expanding operation of the dilating device, and FIG. 48 is an explanatory diagram showing the state when the dilating device is removed from the biological duct. FIG. 49 and FIG. 50 are perspective views showing different modifications of the stent, respectively. Fig. 51 is an explanatory diagram of a case using another stent, Fig. 5
2 to 54 show a balloon dilator suitable for use, FIG. 53 is a side sectional view thereof, FIG. 54 is a side view thereof, and FIG. 54 is a sectional view thereof. FIG. 55 is a sectional view of still another dilator, FIG.
FIG. 7 is an explanatory diagram showing an example of the stent. 1... Stent, 3... Balloon dilator, 4...
... Balloon, 5... Catheter, 6... Easily broken member, 7... Biological conduit, 8... Strictured part, 9... Easily broken member, 11... Easily broken member, 13 ...Biodegradable and absorbable member, 14...Easily peelable member, 15...Easily peelable member, 17...Easily peelable member, 21...Thermosoftening member, 2
8 River thermal expansion member, 36... stent. Applicant's agent Patent attorney Jun Tsuboi Figure 3U Figure 7 Figure 4ff18 Figure 5 Figure 9Ii! 1 Figure Figure Co Figure 13 Figure z Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure Procedural Amendment 2.11.2008! L9 day

Claims (1)

[Claims] In a biological duct dilator that is mounted on a balloon dilator when inserted into a biological constriction, expanded by the expansion of the balloon dilator, and placed in the biological constriction in the biological conduit, the dilator is placed on the balloon dilator. 1. A device for dilating a biological conduit, characterized in that a protective member is provided on at least a part of the outer surface of the dilating device attached thereto to prevent damage to living tissue by the dilating device.