JP3576626B2 - Stent transport indwelling device - Google Patents

Description

[0001]
[Industrial applications]
TECHNICAL FIELD The present invention relates to a medical device for inserting and fixing a stent into a tubular organ, and performing a medical operation according to the same. It can be mainly used as an insertion catheter for insertion and fixation of an intrabiliary stent, an intravascular stent, an artificial blood vessel and the like.
[0002]
[Prior art]
BACKGROUND ART Conventionally, a treatment method for a disease of a tubular organ has been mainly a highly invasive method of incising an affected part and performing a surgical operation for treatment. However, in recent years, for some diseases such as bile duct stenosis, a metallic self-expanding stent is inserted into the affected area using a catheter or the like, and the stent is pushed out from the catheter, expanded and fixed, resulting in stenosis. Minimally invasive treatment of expanding the site has been performed. Further, recently, a method of treating a vascular disease such as an aneurysm by inserting an artificial blood vessel or a wire stent using a catheter has been developed (Japanese Patent Application Laid-Open No. 61-87540, U.S. Pat. No. 580,568). At this time, as a method of pushing out the stent, there is a method of pushing out with a push rod, pulling out from the tip, fixing and pushing out the stent in a bobbin-shaped bobbin (see US Pat. No. 5,306,294). .
[0003]
However, most of the stents currently used for biliary stents and the like have self-expanding properties, and it is known that the greater the self-expanding force, the more easily it is protruded forward when pushed out of a catheter into a tubular organ. Therefore, there is always a risk of displacement of the fixed position. In fact, it has been reported that when a self-expanding inferior vena cava filter used for the treatment of pulmonary embolism is inserted, it is inserted in a rarely inclined state (Kenichi Furudera, Vena cava filter insertion procedure ", Japane Journal of Clinical Radiology, 39, 1457-1463, 1994).
[0004]
[Problems to be solved by the invention]
Therefore, in order to solve the above-mentioned problem, the present invention fixes the front and rear of the stent with a self-expanding force when inserting the stent into the tubular organ, and projects forward when the stent is pushed out from the catheter. It is an object of the present invention to provide a stent delivery and placement device capable of suppressing a force to be applied, suppressing lateral displacement of a stent at the time of expansion, and fixing the stent at an appropriate position.
[0005]
[Means for Solving the Problems]
The above object is solved by the present invention described below.
(1) In a device for inserting a stent into a tubular organ, a tubular support on which the stent is separably disposed, a shaft inserted into the tubular support, and a hole provided on the surface of the tubular support And an expander fixed to the shaft through the shaft and extending in the radial direction of the shaft.
(2) An apparatus for inserting the stent according to (1) into a tubular organ, comprising an insertion catheter for accommodating the tubular support, the shaft, and the expandable body, wherein the tubular support and the shaft are provided. Wherein the tubular support, the shaft, and the expandable body are housed in the insertion catheter so that the tubular support, the shaft, and the expandable body can move in and out of the distal end opening of the insertion catheter.
(3) In the device for inserting the stent according to (1) into a tubular organ, the stent is housed in the insertion catheter, and is moved in the axial direction of the shaft together with the tubular support and the shaft. A stent delivery and indwelling device comprising a pushing catheter capable of pushing out the expansion body from the distal end opening of the insertion catheter.
[0006]
The tubular support used in the present invention is preferably a flexible and slidable tubular body capable of easily moving in a tubular organ, an insertion catheter or a pushing catheter, and the expandable body is formed in the tubular support. Any material having a hole to be housed in the cavity can be used. Here, the outer diameter or 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 outside the shaft to be inserted. It is preferable to set according to the diameter. Further, the material of the tubular support is not limited, but a synthetic resin which does not damage the tissue of the tubular organ and has good biocompatibility and elasticity is preferable. Specific examples include synthetic resins such as a fluorine-based resin and a polyester-based resin.
[0007]
The shaft used in the present invention is inserted into the lumen of the tubular support, fixes the expansion body, and has flexibility and slidability that can easily move in the lumen of the tubular support. Preferred are rods or tubulars. Here, the outer diameter of the shaft is not limited, but is preferably set according to the inner diameter of the tubular support to be inserted. Further, the material of the shaft body is not limited, but a synthetic resin that transmits torque from the hand side well and has good biocompatibility is preferable. Specific examples include polyolefin-based synthetic resins such as polyethylene and polypropylene. Further, a material containing a blade may be used.
[0008]
It is preferable that the expandable body used in the present invention has a shape that can be fixed to the shaft, and can be accommodated in the lumen of the tubular support after the tubular organ is sufficiently expanded and the stent is fixed. Specifically, a spiral shape or a propeller shape is given. At this time, the number of spiral turns and the number of propeller blades are not limited. In addition, the size such as the thickness of the dilation body or the number of dilation bodies to be used is not limited, but it is preferable to set according to the inner diameter of the tubular organ to be inserted and the insertion catheter. The installation position of the expander on the tubular support is preferably provided before and after the stent which is also separably disposed on the tubular support, but may be provided only at the front or only at the rear. The material of the expansion body is not limited, but is preferably a metal, a synthetic resin, or a composite thereof which does not damage the tissue of the tubular organ and has good biocompatibility and elasticity. Specific examples include metals such as stainless steel and Ni-Ti alloy, 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. Further, it is preferable to use a self-expanding body as the expansion body.
[0009]
The insertion catheter used in the present invention is preferably a tubular body having flexibility and slidability that can easily move inside the tubular organ. Here, the outer diameter and inner diameter of the insertion catheter are not limited, but the outer diameter is set according to the inner diameter of the tubular organ to be inserted, and the inner diameter is set to the outer diameter of the inserted tubular support or pushing catheter. It is preferable to set them together. Further, the inner diameter of the insertion catheter can be used as long as the stent, the expansion body, the shaft, the tubular support, and the pushing catheter can all be accommodated. Further, the material of the insertion catheter is not limited, but a synthetic resin which does not damage the tissue of the tubular organ and has good biocompatibility and elasticity is preferable. Specific examples include synthetic resins such as a fluorine-based resin and a polyester-based resin.
[0010]
The pushing catheter used in the present invention is preferably a flexible and slidable tubular body that can easily move inside the insertion catheter. Here, the outer diameter and 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 further, the inner diameter is set according to the outer diameter of the inserted tubular support. Is preferred. Although the material of the pushing catheter is not limited, a synthetic resin having good biocompatibility and elasticity is preferable. Specific examples include polyolefin-based synthetic resins such as polyethylene and polypropylene.
[0011]
The stent used in the present invention is not particularly limited. For example, it can be used as long as it expands the target treatment site of the tubular organ sufficiently and does not block the flow of bodily fluid in the tubular organ.In particular, the shape is cylindrical, spiral coil, sheet And the like rounded into a cylindrical shape. Furthermore, it is preferable that it can be expanded and contracted. The dimensions of the stent are 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 having elasticity with good biocompatibility without damaging the tissue of the tubular organ. Specific examples include metals such as stainless steel and Ni-Ti alloy, 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. Further, those which have been subjected to processing such as to improve the adhesion to the tubular organ and the resistance to displacement are preferable. In addition, the number of stents arranged in the stent delivery and placement device of the present invention is not limited.
[0012]
The stent delivery indwelling device of the present invention transports a stent to a stenosis site formed in a tubular organ such as a blood vessel, a urethral tract, a bile duct, a digestive tract, and a trachea, for example, an aneurysm generated in a blood vessel, and expands the stent there. It is used to treat a stenosis site by placing it. Further, it can be used for inserting a short artificial blood vessel or the like other than the stent.
[0013]
Next, the stent delivery and placement device of the present invention will be described with reference to FIGS. FIG. 1 is a perspective view of a stent delivery and indwelling device 1 of the present invention, in which a stent 2, expansion bodies 3 and 4, a tubular support 5 and a shaft 6 are pushed out of a distal end opening of an insertion catheter 8 by a pushing catheter 7. FIG. FIG. 2 is a sectional view taken along line AA ′ in FIG.
[0014]
The spiral expanders 3 and 4 are fixed as shown in FIG. 2 to a shaft 6 inserted inside the tubular support 5 so as to be positioned before and after the stent 2. Here, the method of bonding the expansion body 4 to the shaft body 6 is not particularly limited, and a known method such as using an adhesive that does not peel off when coming into contact with a body fluid such as blood and has good biocompatibility is used. When housed in the insertion catheter 8, the expansion body 4 is wound around the shaft 6 through a hole 10 provided in the tubular support 5 and is housed in the lumen of the tubular support 5. Or a portion other than the portion fixed to the shaft body 6 and present in the lumen of the tubular support 5 is wound around the tubular support 5 so as to be compressed on the inner wall of the insertion catheter 8. .
[0015]
FIG. 3 shows another embodiment of the expansion body. 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 and placement device 11 of the present invention. As described above, the shape of the expansion body 14 may be a propeller shape protruding from four holes 19 provided in the tubular support 15. At this time, the same number of holes 19 as the propeller-shaped expansion body 14 exist.
[0016]
In addition, the spiral expansion body in the stent transporting and placing device 1 can be provided only at the front part or only at the rear part of the stent 2, but it is necessary to prevent the stent 2 from jumping forward and correct the fixed position. To make it possible, it is preferable to provide them before and after the stent 2. The set positions of the spiral expanders 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 5 so as to improve the slidability of the two and to further accommodate the expansion bodies 3 and 4 in the lumen of the tubular support 5. It is preferable to keep it.
[0017]
Furthermore, it is preferable that the stent delivery and indwelling device 1 of the present invention is provided with a pushing catheter 7. At this time, the pushing catheter 7 may be present separately from the tubular support 5 or may be integrated therewith. In addition, the pushing catheter 7 is disposed behind the stent 2 or the rear spiral expansion body 4, and is preferably in contact with the stent 2 or the rear spiral expansion body 4.
[0018]
When a stent 2 having a weak self-expanding force or a self-expanding force is not used, an expandable body similar to the above is provided inside the stent 2 to expand the tubular organ and expand the stent 2 at the same time. It is also possible.
[0019]
Next, a method of using the stent delivery and 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 and placement device 1 before insertion into a tubular organ. FIG. 5 is a partial cross-sectional view of the stent delivery and placement device 1 inserted into the tubular organ 21. FIG. 6 shows a state where the stent 2, the expansion bodies 3 and 4, and the tubular support body 5 are pushed out of the distal end opening of the insertion catheter 8 by the pushing catheter 7 into the tubular organ 21, and the stent 2, the expansion bodies 3 and 4 are expanded. FIG. 2 is a partial cross-sectional view of the illustrated stent transfer and placement device 1. FIG. 7 is a partial cross-sectional view of the stent delivery and indwelling device 1 showing a state where the expansion bodies 3 and 4 are housed in the lumen of the tubular support 5 after the stent 2 is fixed to the target site 22. FIG. 8 is a partial cross-sectional view of the stent delivery and indwelling device 1 showing a state in which the tubular support 5 and the pushing catheter 7 are housed in the insertion catheter 8.
[0020]
First, as shown in FIG. 4, the spiral expanders 3 and 4 fixed to the shaft 6 in the insertion catheter 8 are wound around the tubular support 5, and in a compressed state, the stent 2 is further placed on the front part. It is held between the spiral expansion body 3 and the rear spiral expansion body 4. Next, as shown in FIG. 5, the catheter is inserted into the tubular organ 21 using an indwelling needle or an indwelling catheter (not shown), and when the distal end of the insertion catheter 8 reaches a position in front of the target portion 22 of the tubular organ 21. The stent 2, the expansions 3 and 4, and the tubular support 5 are pushed out by a pushing catheter 7. At this time, the pushed-out stent 2, the expanded bodies 3 and 4 expand as shown in FIG. 6, but first, the spiral expanded body 3 provided at the front is pushed out from the distal end opening of the insertion catheter 8, and It expands radially within the site 22. Subsequently, the stent 2 is pushed out from the opening at the distal end of the insertion catheter 8. At this time, the force of the stent 2 to protrude forward is suppressed by the spiral expander 3 and does not protrude more than necessary. Further, the rear spiral-shaped expansion body 4 provided at the rear of the stent 2 is pushed out from the distal end opening of the insertion catheter 8, thereby sandwiching the stent 2 together with the front spiral-shaped expansion body 3 from both sides. Therefore, the fixed position of the stent 2 can be corrected by moving the tubular support 5 back and forth. At this time, even when a body fluid flow is present in the inserted tubular organ 21, the flow is not blocked because the stent 2 is cylindrical and the expansion bodies 3 and 4 are spiral.
[0021]
Next, when the stent 2 is fixed at an appropriate position, as shown in FIG. 7, the shaft-shaped body 6 is rotated in the spiral direction so that the spirally expanded spirally expanded bodies 3 and 4 are expanded into the tubular support 5. Is wound up into the lumen of the tubular support 5 through the holes 9 and 10 provided in the hole. Finally, as shown in FIG. 8, after the winding of the spiral expansion bodies 3 and 4 is completed, the tubular support 5 and the pushing catheter 7 are pulled back into the insertion catheter 8, and the insertion catheter 8 is connected to the tubular organ 21. Pull out from inside.
[0022]
When a stent having a weak self-expanding force or a stent having no self-expanding force is used, a spiral expansion body is provided inside the stent 2 similarly to the spiral expansion bodies 3 and 4. When the stent 2 is pushed out from the distal end opening of the insertion catheter 8 into the tubular organ 21, the expandable body expands from the inside of the stent 2, whereby the stent 2 can be expanded in the tubular organ 21. It is possible.
[0023]
Further, the same operation as described above is performed also when using the stent delivery and placement device 11 shown in FIG. 3 which is another embodiment of the expansion body.
[0024]
Finally, in the case of using a stent having a low self-expanding force or a stent having no self-expanding force in the stent delivery and indwelling device of the present invention, it can be used without a pushing catheter and an insertion catheter. At this time, if the spiral expander has a self-expanding force, most of the spiral expander is outside the tubular support even before being wound into the lumen of the tubular support before insertion into the tubular organ. If the self-expanding force is weak or non-existent, it is wound in advance in the lumen of the tubular support, and the shaft is rotated in the opposite direction to the winding direction to recover the shaft during expansion. Can be extended.
[0025]
【Example】
Hereinafter, the present invention will be described based on examples.
[0026]
(Example 1)
The stent transfer indwelling device 1 shown in FIG. 1 was produced as follows.
A superelastic metal plate (METGLAS 2705M, manufactured by Nippon Amorphous Metals Co., Ltd.) having a thickness of about 10 μm, a width of 20 mm, and a length of 30 mm is used as the stent 2, and the spiral expansion bodies 3 and 4 have a thickness of about 10 μm. A stainless steel plate (manufactured by Nippon Hakko Co., Ltd.) having a size of 10 μm, a width of 5 mm, and a length of 50 mm was formed and used. The tubular support 5 and the insertion catheter 8 are extruded using polyester elastomer (Toyobo Co., Ltd., Perprene P150B), and the pushing catheter 7 and the shaft 6 are extruded using polyethylene resin (Mitsui Petrochemical Co., Ltd., Hizex 5500B) as raw materials. It was produced using a tube molding machine. At this time, the outer diameter of the insertion catheter 8 is 8 Fr. (3 Fr. = 1 mm). The outer diameters of the tubular support 5, the pushing catheter 7, and the shaft 6 were 1.0 mm, 2.3 mm, and 0.7 mm, respectively.
[0027]
Next, the spiral expanders 3 and 4 are bonded to the shaft 6 with a commercially available adhesive, wound around the outside of the tubular support 5 through the holes 9 and 10, and the stent 2 is further wound with the spiral expanders 3 and 4. The tubular organ is wound around the outside of the tubular support 5 and inserted into the insertion catheter 8 in a compressed state, and is made of a transparent silicone rubber (Cyrus Tech, manufactured by Dow Corning Co., Ltd.) having an inner diameter of 5 mm. The insertion catheter 8 was inserted into 21 models. After the insertion, when reaching the position in front of the target site 22, the pusher catheter 7 in the order of the front spiral expander 3, the stent 2, and the rear spiral expander 4 is used to push the tubular from the distal opening of the insertion catheter 8 by the pushing catheter 7. Extruded into the organ 21 model.
[0028]
As a result, the spiral expanders 3 and 4 expanded almost 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 expansion bodies 3 and 4, and the expansion bodies 3 and 4 are wound into the lumen of the tubular support 5, and the expansion bodies 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 remained cylindrical in the target portion 22 even after the insertion catheter 8 was pulled out, and was fixed without displacement.
[0029]
(Comparative Example 1)
As a comparative example of Example 1, an experiment similar to that of Example 1 was performed by preparing an insertion catheter, a stent housed in the lumen thereof, and a stent delivery and indwelling device including only a pushing catheter for pushing out the stent. As a result, it was visually confirmed that the stent delivery and indwelling device of Comparative Example 1 was fixed after being pushed forward from the target site when the stent was pushed out from the distal end opening of the insertion catheter.
[0030]
(Example 2)
The stent 2 was fixed in a state where physiological saline was allowed to flow into the tubular organ 21 model using the same stent transporting and indwelling device as in Example 1. This operation was performed under a constant flow rate of 6 l / min and a water pressure of 100 mmHg. As a result of performing the same operation as in Example 1, it could be visually confirmed that the stent 2 was fixed in the target portion 22 without being washed away by the water flow, and was kept cylindrical without any displacement.
[0031]
(Comparative Example 2)
As a comparative example of Example 2, the same experiment as in Example 2 was performed using the same stent transporting and placing device as in Comparative Example 1. As a result, in the stent delivery and indwelling device of Comparative Example 2, when the stent is pushed out from the opening at the distal end of the insertion catheter, the stent jumps forward from the target site, and is then pushed back by the water flow and then fixed. This was visually confirmed.
[0032]
(Example 3)
The same stent delivery 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 renal artery bifurcation. The branch of the renal artery is confirmed by performing angiography, the insertion catheter 8 is inserted to a position in front of the branch, and the stent 2 is extruded and expanded in the renal artery bifurcation having an inner diameter of 7 to 8 mm. Was confirmed by angiography. As a result, the stent 2 keeps its cylindrical shape in the renal artery bifurcation in the blood vessel even after the operation and is fixed without displacement, and it is confirmed by angiography that there is no interruption of blood flow to the renal artery by sufficient expansion. It could be confirmed.
[0033]
(Comparative Example 3)
As a comparative example of Example 3, an experiment similar to that of Example 3 was performed using the same stent delivery and placement device as in Comparative Example 1. As a result, it was confirmed by angiography that when the stent was extruded from the distal end opening of the insertion catheter, it protruded forward from the target site, and was then pushed back by the blood flow and then fixed.
[0034]
(Example 4)
A stent transport indwelling device in which a spiral expansion body for assisting expansion was further provided inside the holding site of the stent 2 on the same stent transport indwelling device as in Example 1 was used as the stent 2, with a thickness of about 5 μm, a width of 20 mm and a length The same experiment as in Example 1 was performed using a stainless steel plate having a thickness of 30 mm. In the stent transfer indwelling device provided with a spiral expansion body for assisting expansion, after the stent 2 is pushed out into the tubular organ 21 model, the stent 2 is inserted by the expansion force of the spiral expansion body for expansion assistance. Even after the catheter 8 was pulled out of the tubular organ 21 model, it could be visually confirmed that the catheter 8 remained in the target portion 22 and was fixed without shifting.
[0035]
(Comparative Example 4)
As a comparative example of Example 4, a stent transportation indwelling device in which a spiral expansion body for assisting expansion was not provided in the same stent transportation indwelling device as in Example 1 was used as a stent with a thickness of about 5 μm, a width of 20 mm and a length of 30 mm. An experiment similar to that of Example 1 was performed using the stainless steel plate. In the case where the spiral expansion body for assisting expansion was not provided, it was visually confirmed that when the stent was pushed out from the opening at the distal end of the insertion catheter, the stent could not completely expand within the target site and slipped. Was.
[0036]
【The invention's effect】
As described in detail above, the stent delivery and placement device of the present invention enables the stent to be easily delivered to the target site by being inserted into the tubular organ, and at the same time, the stent is inserted into the tubular organ at the time of insertion. It is possible to prevent protrusion, to prevent displacement at a fixed position such as lateral displacement, and to correct the fixed position, and it is possible to fix accurately.
[Brief description of the drawings]
FIG. 1 is a perspective view of a stent delivery and indwelling device of the present invention.
FIG. 2 is a cross-sectional view taken along a line AA ′ of the stent delivery and placement device shown in FIG. 1;
FIG. 3 is a cross-sectional view when a propeller-shaped expansion body is used instead of the spiral expansion body in FIG. 2;
FIG. 4 is a partial cross-sectional view of the stent delivery and placement device of the present invention before insertion into a tubular organ.
FIG. 5 is a partial cross-sectional view after insertion of the stent delivery device of the present invention into a tubular organ.
FIG. 6 is a partial cross-sectional view of the stent delivery and indwelling device of the present invention after the stent, the expandable body, and the tubular support for a tubular organ are extruded by a pushing catheter.
FIG. 7 is a partial cross-sectional view after the expansion body is housed in the lumen of the tubular support of the stent delivery and placement device of the present invention.
FIG. 8 is a partial cross-sectional view of the stent delivery indwelling device of the present invention after the stent is inserted and the tubular support and the pushing catheter are housed in the insertion catheter.
[Explanation of symbols]
1,11. 1. The stent delivery and indwelling device of the present invention Stents 3,4. Spiral expansion body 5,15. Tubular support 6,16. Shaft 7. Pushing catheter8. Insertion catheters 9, 10, 19; Hole 14. Propeller-like expansion body 21. Tubular organ 22. Target part

Claims (5)

An instrument 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 shaft provided in a surface of the tubular support. An expansion body fixed to the body and expanding in the radial direction of the shaft body. 2. An apparatus for inserting a stent according to claim 1 into a tubular organ, comprising an insertion catheter for accommodating the tubular support, the shaft and the expandable body, wherein the tubular support and the axial direction of the shaft are provided. Wherein the tubular support, the shaft, and the expandable body are housed so that the tubular support, the shaft, and the expandable body can be moved in and out of the distal end opening of the insertion catheter. 2. The device for inserting the stent according to claim 1 into a tubular organ, wherein the expandable body is housed in the insertion catheter, and is moved in the axial direction of the shaft together with the tubular support and the shaft. And a pushing catheter capable of pushing the insertion catheter out of the distal end opening of the insertion catheter. The device for inserting a stent according to claim 1 into a tubular organ, wherein the expansion body has a spiral or propeller-like shape. 2. The device for inserting a stent into a tubular organ according to claim 1, wherein an installation position of the expansion body on the tubular support is provided before and after a stent detachably arranged on the tubular support. Stent delivery device.

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