JPH08238253A - Stent carrying and detaining tool - Google Patents

Abstract

PURPOSE: To appropriately fix a stent at an aimed site in a circular organ by combining a circular supporting body wherein the stent is arranged separably, a shaft body inserted therein and dilators fixed on the shaft body through the hole of the circular supporting body and dilated in the radial direction. CONSTITUTION: When a stent carrying and detaining tool 1 is used, at first, each of spiral dilators 3 and 4 fixed on a shaft body 6 in a catheter 8 for insertion is wound on a circular supporting body 5 and a stent 2 is held between the dilators 3 and 4. Then, the catheter 8 for insertion is inserted in a circular organ 21 and at this aimed site 22, the stent 2, dilators 3 and 4 and the circular supporting body 5 are respectively pushed out by means of a pushing catheter 7 and these are each dilated to fix a stent 2. Successively, by rotating the shaft body 6 in the spiral direction, each of dilators 3 and 4 is wound in the inner cavity from each of holes 9 and 10 of the circular supporting body 5. Thereafter, the circular supporting body 5 and the pushing catheter 7 are returned back into the catheter 8 for insertion.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device for inserting a stent into a tubular organ, fixing the stent, and performing a medical procedure in accordance therewith. It can be mainly used as an insertion catheter for inserting and fixing an intrabile duct stent, an intravascular stent, an artificial blood vessel, or the like.

[0002]

2. Description of the Related Art Conventionally, the main treatment method for diseases of tubular organs has been a highly invasive method in which the affected area is incised and a surgical operation is performed. However, in recent years, for some diseases such as biliary stricture, a metallic self-expanding stent is inserted into the affected area using a catheter, etc., and the stent is pushed out from the catheter, expanded, fixed, and strictured. Minimally invasive treatment to expand the site has come to be performed. Furthermore, recently, a method of treating an vascular disease such as an aneurysm by inserting an artificial blood vessel or a wire stent using a catheter is being developed (Japanese Patent Laid-Open No. 61-87540, US Pat. 58
0568, etc.). At this time, as a method of pushing out the stent, there are methods such as pushing out with a push rod, pulling out from the tip end portion, and fixing the stent into a bobbin-shaped wound bobbin and pushing out (US Pat. No. 5,306,294).
No.).

However, most of the stents currently used for intra-bile duct stents and the like have self-expandability, and when pushing out from a catheter into a tubular organ, the greater the self-expanding force, the easier it is to jump forward. It is known that there is always a risk of displacement of the fixed position. In fact, when inserting the inferior vena cava filter, which has self-expanding properties and is used to treat pulmonary embolism,
It has been reported that it is inserted in a rarely tilted state (Kenji Furudera, "Inferior Vena Cava Filter-Insertion Technique", Japane
se Journal of Clinical Radiology, 39, 1457-1463, 19
94).

[0004]

Therefore, in order to solve the above problems, the present invention secures the front and rear of a stent with a material having a self-expanding force when inserting the stent into a tubular organ. An object of the present invention is to provide a stent delivery indwelling device capable of suppressing the force of jumping forward when being pushed out from a catheter, suppressing lateral displacement of the stent during expansion, and fixing the stent at an appropriate position.

[0005]

The above object can be solved by the present invention described below. (1) In a device for inserting a stent into a tubular organ,
The stent is fixed to the shaft body through a tubular support in which the stent is separably disposed, a shaft body inserted into the tubular support body, and a hole provided in the surface of the tubular support body, and the radial direction of the shaft body is secured. A stent delivery indwelling device comprising an expanding body to be expanded. (2) An instrument for inserting the stent according to (1) into a tubular organ, which has an insertion catheter for accommodating the tubular support, the shaft and the expander, and the tubular support and the shaft. A stent delivery indwelling device, wherein the tubular support, the shaft, and the expander are housed so that they can be moved in and out from the distal end opening of the insertion catheter by moving the catheter in the axial direction. (3) In the device for inserting the stent according to (1) into a tubular organ, the device is housed in the insertion catheter and moved in the axial direction of the shaft together with the tubular support and the shaft, A stent delivery indwelling device comprising a pushing catheter capable of pushing out the expanded body from the distal end opening portion of the insertion catheter.

The tubular support used in the present invention is preferably a tubular body having flexibility and slidability that can be easily moved in a tubular organ, an insertion catheter or a pushing catheter, and a tubular support for an expansion body. Anything can be used as long as it has a hole for storing it in the body lumen. Here, the outer diameter or the inner diameter of the tubular support is not limited, but the outer diameter is set according to the inner diameter of the tubular organ to be inserted, the insertion catheter or the pushing catheter, and the inner diameter is the outer diameter of the shaft body to be inserted. It is preferable to set according to the diameter. The material of the tubular support is not limited, but a synthetic resin that does not damage the tissue of the tubular organ and has elasticity with good biocompatibility is preferable. Specific examples include synthetic resins such as fluorine resins and polyester resins.

The shaft used in the present invention is inserted into the lumen of the tubular support, fixes the expansion body, and is flexible and slidable so that it can be easily moved in the lumen of the tubular support. A rod-shaped body or a tubular body having properties is preferable. Here, the outer diameter of the shaft is not limited, but it is preferably set according to the inner diameter of the tubular support to be inserted. Further, the material of the shaft is not limited, but a synthetic resin having good elasticity that allows good transmission of torque from the hand side and good biocompatibility is preferable. Specific examples include polyolefin synthetic resins such as polyethylene and polypropylene. Further, a blade may be contained.

The expander used in the present invention is preferably shaped so that it can be fixed to the shaft and can be stored in the lumen of the tubular support after the tubular organ is expanded sufficiently and the stent is fixed. . Specifically, a spiral shape or a propeller shape can be mentioned. At this time, the number of spiral turns and the number of propeller blades are not limited. The size of the expander, such as the thickness, or the number of expanders to be used is not limited, but is preferably set according to the inner diameter of the tubular organ to be inserted and the insertion catheter. The position of the expansion body on the tubular support is preferably provided before and after the stent which is also separably arranged on the tubular support, but it may be provided only on the front part or only on the rear part. The material of the expander is not limited, but metal, synthetic resin or a composite thereof which does not damage the tissue of the tubular organ and has elasticity with good biocompatibility is preferable. Specific examples include metals such as stainless steel and Ni—Ti alloys, synthetic resins such as fluorine-based resins and silicon-based resins, and those obtained by coating the surfaces of these metals with these synthetic resins. Furthermore, it is preferable to use an expander having self-expandability.

The insertion catheter used in the present invention is preferably a tubular body having flexibility and slidability capable of being easily moved within the tubular organ. Here, the outer diameter and the inner diameter of the insertion catheter are not limited, but the outer diameter is
It is preferably set according to the inner diameter of the tubular organ to be inserted, and further, the inner diameter is preferably set according to the outer diameter of the tubular support or the pushing catheter to be inserted. Furthermore, the inner diameter of the insertion catheter can be used as long as the stent, the expandable body, the shaft body, the tubular support body and the pushing catheter can all be accommodated. In addition, the material of the insertion catheter is not limited, but a synthetic resin that does not damage the tissue of the tubular organ and has elasticity with good biocompatibility is preferable.
Specific examples include synthetic resins such as fluorine resins and polyester resins.

The pushing catheter used in the present invention is preferably a tubular body having flexibility and slidability capable of easily moving inside the insertion catheter. Here, the outer diameter and the inner diameter of the pushing catheter are not limited, but the outer diameter is set according to the inner diameter of the insertion catheter to be inserted, and the inner diameter is set according to the outer diameter of the tubular support body to be inserted. Is preferred. The material of the pushing catheter is not limited, but a synthetic resin having good biocompatibility and elasticity is preferable. Specific examples include polyolefin synthetic resins such as polyethylene and polypropylene.

The stent used in the present invention is not particularly limited. For example, it can be used as long as the target treatment site of the tubular organ is sufficiently expanded and does not block the flow of body fluid in the tubular organ, and in particular, the shape thereof is cylindrical, spiral coiled, sheet. Examples include those obtained by rolling the above into a cylindrical shape. Further, it is preferably stretchable. The size of the stent is set according to the inner diameter of the tubular organ to be inserted. The material of the stent is preferably a metal, a synthetic resin, or a composite thereof which does not damage the tissue of the tubular organ and has elasticity with good biocompatibility. Specific examples include metals such as stainless steel and Ni—Ti alloys, synthetic resins such as fluorine-based resins and silicon-based resins, and those obtained by coating the surfaces of these metals with these synthetic resins. Furthermore, it is preferable to perform a process for improving the adhesion to the tubular organ and the shift resistance. Further, the number of stents arranged in the stent delivery indwelling device of the present invention is not limited.

The stent delivery indwelling device of the present invention delivers a stent to a stenosis site formed in a tubular organ such as a blood vessel, a urethral duct, a bile duct, a digestive tract, or a trachea, for example, an aneurysm formed in a blood vessel, and the like. It is used to treat a stricture site by expanding and placing a stent. It can also be used to insert a short artificial blood vessel or the like other than the stent.

Next, the stent delivery indwelling device of the present invention is shown in FIG.
Description will be made with reference to FIGS. FIG. 1 is a perspective view of a stent delivery indwelling device 1 of the present invention in which a stent 2, expansion bodies 3 and 4, a tubular support body 5 and a shaft body 6 are extruded by a pushing catheter 7 from a distal end opening portion of an insertion catheter 8. It is a figure. Further, FIG. 2 is a cross-sectional view of the line segment AA ′ in FIG.

The spiral-shaped expansion bodies 3 and 4 correspond to the stent 2
As shown in FIG. 2, it is fixed to the shaft body 6 inserted inside the tubular support body 5 so as to be positioned in the front and rear. Here, extension body 4
The method of adhering to the shaft body 6 is not particularly limited, and examples thereof include known methods such as using an adhesive that does not peel off when it comes into contact with body fluid such as blood and has good biocompatibility. Insertion catheter 8
When housed within, the expander 4 is either housed and contained within the lumen of the tubular support 5 wrapped around the shaft 6 through a hole 10 provided in the tubular support 5, or Shaft 6
The portion other than the portion fixed to the inside of the lumen of the tubular support 5 is wound around the outside of the tubular support 5 so as to be compressed by the inner wall of the insertion catheter 8.

Another embodiment of the expansion body is shown in FIG. FIG. 3 is a radial cross-sectional view of the shaft body 16 when the propeller-shaped expansion body 14 is fixed to the shaft body 16 in the stent delivery indwelling device 11 of the present invention. In this way, the expansion body 14
The shape may be a propeller shape protruding from four holes 19 provided in the tubular support 15. At this time, the hole 19
Exist in the same number as the propeller-shaped expansion bodies 14.

Further, the spiral expansion body of the stent delivery indwelling device 1 can be provided only in the front part or only in the rear part of the stent 2, but it is possible to prevent the stent 2 from popping out forward and correct the fixed position. To be able to do
It is preferably provided before and after the stent 2. The setting positions of the spiral expansion bodies 3 and 4 are preferably in contact with the stent 2. A slight gap is provided between the shaft body 6 and the tubular support body 5 in order to improve slidability between them and to accommodate the expansion bodies 3 and 4 in the inner cavity of the tubular support body 5. It is preferable to keep.

Furthermore, the stent delivery indwelling device 1 of the present invention
It is preferable to provide a pushing catheter 7.
At this time, the pushing catheter 7 may be present separately from the tubular support 5 or may be integrated with the tubular support 5. Further, the pushing catheter 7 is disposed behind the stent 2 or the rear-side spiral expansion body 4, and preferably is brought into contact with the stent 2 or the rear-side spiral expansion body 4.

When the stent 2 having a weak self-expansion force or no self-expansion force is used, an expander similar to the above is provided inside the stent 2 to expand the tubular organ and at the same time. Can be extended.

Next, a method of using the stent delivery indwelling device 1 of the present invention will be described with reference to FIGS. FIG. 4 is a partial cross-sectional view of the stent delivery indwelling device 1 before insertion into a tubular organ. FIG. 5 is a partial cross-sectional view of the stent delivery indwelling device 1 inserted into the tubular organ 21. FIG. 6 shows a tubular organ 21.
The stent 2, the expanders 3 and 4, and the tubular support 5 are pushed out from the distal end opening of the insertion catheter 8 by the pushing catheter 7, and the stent delivery indwelling device 1 showing the expanded state of the stent 2, the expanders 3 and 4 is shown. FIG. FIG. 7 is a partial cross-sectional view of the stent delivery indwelling device 1 showing a state in which the expanders 3 and 4 are housed in the inner cavity of the tubular support 5 after the stent 2 is fixed to the target site 22. FIG.
FIG. 4 is a partial cross-sectional view of the stent delivery indwelling device 1 showing a state in which the tubular support 5 and the pushing catheter 7 are housed in the insertion catheter 8.

First, as shown in FIG. 4, the spiral-shaped expansion bodies 3 and 4 fixed to the shaft body 6 in the insertion catheter 8 are wrapped around the tubular support body 5, and the stent 2 is further compressed in a compressed state. It is held between the front spiral expander 3 and the rear spiral expander 4. Next, as shown in FIG. 5, a tubular organ 2 is prepared by using an indwelling needle or an indwelling catheter (not shown).
1 and the tip of the insertion catheter 8 is a tubular organ 2.
The stent 2, the expanders 3 and 4, and the tubular support 5 are pushed out by the pushing catheter 7 when the front position of the target site 22 of No. 1 is reached. At this time, the extruded stent 2, the expansion bodies 3 and 4 expand as shown in FIG. 6, but first, the spiral expansion body 3 provided in the front part is extruded from the distal end opening portion of the insertion catheter 8, It expands radially within the region 22. Subsequently, the stent 2 is pushed out from the distal end opening portion of the insertion catheter 8. At this time, the force of jumping out of the stent 2 toward the front side is suppressed by the spiral expansion body 3, and does not go out further than necessary. Further, a rear spiral-shaped expander 4 provided at the rear of the stent 2.
Is pushed out from the distal end opening portion of the insertion catheter 8, the stent 2 is sandwiched from both sides together with the front-side spiral expansion body 3, so that the tubular support 5
By moving the back and forth, the fixed position of the stent 2 can be corrected. At this time, even if there is a flow of body fluid in the inserted tubular organ 21, this flow is not blocked because the stent 2 is cylindrical and the expanders 3 and 4 are spiral.

Next, when the stent 2 is fixed in an appropriate position, as shown in FIG. 7, by rotating the shaft body 6 in the spiral direction, the spiral expanders 3 and 4 expanded in a spiral shape are tubular. It is wound into the lumen of the tubular support 5 through the holes 9 and 10 provided in the support 5. Finally, as shown in FIG. 8, after winding the spiral expanders 3 and 4, the tubular support 5 and the pushing catheter 7 are inserted.
Then, the catheter 8 for insertion is pulled out from the inside of the tubular organ 21.

When the stent 2 having a weak self-expansion force or a stent having no self-expansion force is used,
A spiral-shaped expansion body is also provided inside the stent 2 in the same manner as the spiral-shaped expansion bodies 3 and 4, and when the stent 2 is extruded into the tubular organ 21 from the distal end opening of the insertion catheter 8. By expanding from the inside of the stent 2, it is possible to expand the stent 2 in the tubular organ 21.

Also, when the stent delivery indwelling device 11 shown in FIG. 3, which is another embodiment of the expandable body, is used, the same operation as described above is performed.

Finally, in the stent delivery indwelling device of the present invention, when a stent having a weak self-expansion force or a stent having no self-expansion force is used, it can be used without a pushing catheter and an insertion catheter. At this time, when the spiral expander has a self-expanding force, most of the spiral expander is outside the tubular support before being inserted into the tubular organ even when it is wound inside the lumen of the tubular support. If the self-expanding force is weak or absent, it should be wound in the lumen of the tubular support in advance, and the shaft should be swirled by rotating in the opposite direction to the winding direction to collect the shaft. It is possible to extend the extension body of.

[0025]

EXAMPLES The present invention will be described below based on examples.

Example 1 A stent delivery indwelling device 1 shown in FIG. 1 was produced as follows. The thickness of the stent 2 is about 1
A super elastic metal plate (METGLAS 2705M manufactured by Nippon Amorphous Metals Co., Ltd.) having a size of 0 μm, a width of 20 mm, and a length of 30 mm is used, and the spiral expansion bodies 3 and 4 have a thickness of about 10 μm, a width of 5 mm, and a length of 5 mm. A 50 mm-thick stainless plate (manufactured by Nihon-Hatsuri Co., Ltd.) was used after being molded. The tubular support 5 and the insertion catheter 8 are extruded from polyester elastomer (Toyobo Co., Ltd., Perprene P150B), the pushing catheter 7 and the shaft 6 are extruded from polyethylene resin (Mitsui Petrochemical Co., Ltd., Hi-Zex 5500B). It was produced using a tube molding machine. This time,
The outer diameter of the insertion catheter 8 is 8 Fr. (3Fr. = 1m
m). The outer diameters of the tubular support 5, the pushing catheter 7, and the shaft 6 are 1.0 m each.
m, 2.3 mm and 0.7 mm.

Next, the spiral expansion bodies 3 and 4 are attached to the shaft body 6.
To the outside of the tubular support 5 through the holes 9 and 10 and the stent 2 wrapped between the spiral expanders 3 and 4 outside the tubular support 5 and allowed to compress. In the insertion catheter 8 in a state,
Transparent silicone rubber with an inner diameter of 5 mm (Dow Corning
The insertion catheter 8 was inserted into a tubular organ 21 model manufactured by Cyrus Tech Co., Ltd. After the insertion, when reaching the front position of the target site 22, the front spiral-shaped expansion body 3, the stent 2, and the rear spiral-shaped expansion body 4 are sequentially inserted by the pushing catheter 7 from the distal end opening portion of the insertion catheter 8. Extruded into Organ 21 model.

As a result, the spiral expanders 3 and 4 expanded substantially perpendicular to the cross section of the tubular organ 21 model. After confirming the expansion of the stent 2, the shaft body 6 is rotated in the winding direction of the spiral-shaped expansion bodies 3 and 4, and the expansion bodies 3 and 4 are wound into the lumen of the tubular support body 5, and the expansion body 3 and 4, the tubular support 5, and the pushing catheter 7 were housed in the insertion catheter 8, and the insertion catheter 8 was pulled out from the tubular organ 21 model. It was visually confirmed that the stent 2 was kept in a cylindrical shape in the target site 22 even after the insertion catheter 8 was pulled out, and was fixed without being displaced.

(Comparative Example 1) As a comparative example of Example 1, a stent delivery indwelling device having only an insertion catheter, a stent housed in its lumen, and a pushing catheter for pushing out the stent was prepared, and the same procedure as in Example 1 was performed. The experiment was done.
As a result, it was visually confirmed that, in the stent delivery indwelling device of Comparative Example 1, when the stent was pushed out from the distal end opening portion of the insertion catheter, it was fixed forward after protruding from the target site.

(Example 2) Using the same stent delivery indwelling device as in Example 1, the stent 2 was fixed while the physiological saline was flown into the tubular organ 21 model. This operation uses a water flow rate of 6 liters / min and a water pressure of 100 mm.
It was carried out under constant Hg conditions. As a result of performing the same operation as in Example 1, the stent 2 was not washed by the water flow at all,
It was visually confirmed that the cylindrical shape was maintained in the target portion 22 and fixed without shifting.

(Comparative Example 2) As a comparative example of Example 2, the same experiment as in Example 2 was conducted using the same stent delivery indwelling device as in Comparative Example 1. As a result, in the stent delivery indwelling device of Comparative Example 2, when the stent was pushed out from the distal end opening of the insertion catheter, it popped out forward from the target site,
Furthermore, it was visually confirmed that the film was fixed after being pushed back by a water stream.

Example 3 The same stent delivery indwelling device as in Example 1 was inserted from the femoral artery of a Beagle dog weighing about 10 kg to the abdominal aorta at the bifurcation of the renal artery. The branch portion of the renal artery is confirmed by performing angiography, the insertion catheter 8 is inserted to the position in front of the branch portion, and the stent 2 has an inner diameter of 7 to 7 mm.
The state of the stent 2 was confirmed by angiography by extruding it in the 8 mm renal artery bifurcation and expanding it. As a result, the stent 2 has a cylindrical shape in the bifurcation of the renal artery in the blood vessel even after the operation and is fixed without being displaced. Moreover, it is confirmed by angiography that there is no blockage of blood flow to the renal artery due to sufficient expansion. It could be confirmed.

(Comparative Example 3) As a comparative example of Example 3, the same experiment as in Example 3 was conducted using the same stent delivery indwelling device as in Comparative Example 1. As a result, it was confirmed by angiography that when the stent was pushed out from the distal end opening of the insertion catheter, it jumped out forward from the target site and was pushed back by blood flow and then fixed.

(Embodiment 4) A stent delivery indwelling device having a stent delivery indwelling device similar to that of Example 1 further provided with a spiral expansion body for assisting expansion inside the holding portion of the stent 2 is thick as the stent 2. The same experiment as in Example 1 was conducted using a stainless plate having a size of about 5 μm, a width of 20 mm, and a length of 30 mm. In the stent delivery indwelling device provided with the spiral expansion body for expansion assistance, after the stent 2 is pushed into the tubular organ 21 model, the stent 2 is inserted by the expansion force of the spiral expansion body for expansion assistance. It was visually confirmed that even after the catheter 8 was pulled out from the tubular organ 21 model, it remained cylindrical in the target site 22 and was fixed without being displaced.

(Comparative Example 4) As a comparative example of Example 4, a stent delivery indwelling device in which the same spiral delivery device as that in Example 1 was not provided with a spiral expansion body for expansion assistance was used.
Thickness about 5μm, width 20mm, length 30m as a stent
The same experiment as in Example 1 was conducted using a stainless steel plate of m. It is possible to visually confirm that when the stent is pushed out from the distal end opening of the insertion catheter, the stent does not expand completely and slips off within the target site when the stent is not provided with a spiral expansion body for expansion assistance. It was

[0036]

As described in detail above, the stent delivery indwelling device of the present invention can easily deliver the stent to the target site by inserting it into the tubular organ, and at the same time, Prevention of popping out in tubular organs,
It is possible to prevent a shift at a fixed position such as a lateral shift and to correct the fixed position, so that the fixing can be performed accurately.

[Brief description of drawings]

FIG. 1 is a perspective view of a stent delivery indwelling device of the present invention.

FIG. 2 is a line segment A- of the stent delivery indwelling device shown in FIG.
It is a sectional view of A '.

FIG. 3 is a cross-sectional view of a case where a propeller-shaped expansion body is used instead of the spiral-shaped expansion body in FIG.

FIG. 4 is a partial cross-sectional view of the stent delivery indwelling device of the present invention before insertion into a tubular organ.

FIG. 5 is a partial cross-sectional view of the stent delivery indwelling device of the present invention after being inserted into a tubular organ.

FIG. 6 is a partial cross-sectional view of a stent delivery indwelling device of the present invention after a stent, a dilator and a tubular support for a tubular organ have been pushed out by a pushing catheter.

FIG. 7 is a partial cross-sectional view of the stent delivery indwelling device of the present invention after the expandable body is housed in the lumen of the tubular support body.

FIG. 8 is a partial cross-sectional view of the stent delivery indwelling device of the present invention after inserting the stent and after accommodating the tubular support and the pushing catheter in the insertion catheter.

[Explanation of symbols]

 1,11. 1. The stent delivery indwelling device of the present invention Stent 3,4. Spiral expansion body 5,15. Tubular support 6,16. Shaft 7. Pushing catheter 8. Insertion catheter 9, 10, 19. Hole 14. Propeller-shaped expansion body 21. Tubular organ 22. Target site

Claims (3)

[Claims] 1. A device for inserting a stent into a tubular organ, comprising: a tubular support on which the stent is separably disposed; a shaft inserted into the tubular support; and a surface of the tubular support. A stent delivery indwelling device comprising: an expansion body that is fixed to the shaft body through a hole and expands in the radial direction of the shaft body. 2. An instrument for inserting the stent according to claim 1 into a tubular organ, comprising an insertion catheter for accommodating the tubular support, the shaft and the expander. A stent delivery indwelling device characterized in that the tubular support, the shaft and the expansion body are housed so as to be able to move in and out from the distal end opening of the insertion catheter by moving in the axial direction of the shaft. 3. A device for inserting the stent according to claim 1 into a tubular organ, which is housed in the insertion catheter and moved in the axial direction of the shaft together with the tubular support and the shaft. According to the present invention, there is provided a stent delivery indwelling device having a pushing catheter capable of pushing the expanded body out of the distal end opening portion of the insertion catheter.