WO2014115306A1

WO2014115306A1 - Stent delivery device

Info

Publication number: WO2014115306A1
Application number: PCT/JP2013/051601
Authority: WO
Inventors: 谷和佳; 澤田明
Original assignee: テルモ株式会社
Priority date: 2013-01-25
Filing date: 2013-01-25
Publication date: 2014-07-31

Abstract

A stent delivery device (10) is provided with: a tube (12) to which an accommodating lumen (24) is provided for accommodating a coil stent (14) so that the coil stent (14) can advance and retreat, the coil stent (14) being implanted in a blood vessel, and the tube (12) being deliverable into the blood vessel; a pusher wire (28) for pushing out the coil stent (14) from the tube (12) by moving relative to the tube (12), the pusher wire (28) being accommodated in the accommodating lumen (24); and a rotation mechanism (40) capable of rotating the tube (12) about an axis of the tube (12) when the tube (12) and the push wire (28) move relative to each other, the rotation mechanism (40) being connected to a proximal end of the tube (12).

Description

Stent delivery device

The present invention relates to a stent delivery device for indwelling a coiled indwelling object in a living body lumen.

In the abdominal aorta descending below the diaphragm of the aorta (biological lumen), an abdominal aortic aneurysm occurs due to a cause such as weakening of the blood vessel wall. In the treatment of an abdominal aortic aneurysm, for example, an artificial blood vessel replacement method in which the abdominal aorta is excised and replaced with an artificial blood vessel, or a stent graft treatment in which a new blood flow path is formed by delivering and placing a stent graft with a delivery device Etc. are performed.

By the way, the treatment described above is not performed at the level of signs of aneurysm (for example, the degree of abdominal aorta bulging somewhat) because the invasion to the patient is large, and the course of the lesion is observed. Therefore, the patient lives with care for the affected part, and the psychological burden is large.

For this reason, the present applicant is examining a treatment for preventing the progression of the abdominal aortic aneurysm from the initial stage to the middle stage of the abdominal aortic aneurysm. Specifically, in the initial stage or the middle stage, the indwelling object is placed at the treatment site (where the aneurysm is generated) to reinforce the blood vessel wall. Examples of the indwelling object include a coil stent that can follow and adhere to blood vessels of various thicknesses (inner diameters). In other words, in treatment, the coil stent is placed in close contact with the blood vessel wall at the treatment site, thereby strengthening the blood vessel wall and suppressing the expansion of the abdominal aorta.

Here, although it is not a technique for treating an abdominal aortic aneurysm, JP 2007-524449 A discloses a delivery device for delivering a coil stent. The coil stent is elastically deformed and accommodated in the tube of the catheter, delivered to the treatment site, and pushed out from the distal end of the tube by the pusher wire, thereby returning to the coil shape.

However, the coil stent as disclosed in JP-T-2007-524449 is elastically restored immediately after being pushed out from the delivery device, and because of its contact with the blood vessel wall during deployment, the shape and posture thereof, The unfolding position will change easily. Therefore, in particular, in a large blood vessel, it is difficult to deploy the coil stent accurately and smoothly along the blood vessel wall by simply extruding the coil stent from the delivery device.

The present invention has been made in view of the above circumstances, and can place a coiled indwelling object in close contact with a treatment site in a living body lumen with high accuracy. An object of the present invention is to provide a stent delivery device capable of reinforcing a cavity.

In order to achieve the above object, a stent delivery device according to the present invention is provided with a lumen that can be delivered through a living body lumen, and that can house a coiled indwelling object placed in the living body lumen. A tubular body that is connected to the proximal end side of the tubular body, and an extruded member that is accommodated in the lumen and that moves relative to the tubular body to push out the indwelling material from the tubular body. And a rotating mechanism capable of rotating the tubular body around the axial center of the tubular body when the pushing member is relatively moved.

According to the above, the stent delivery device is provided with the rotation mechanism capable of rotating the tubular body around the axial center of the tubular body when the tubular body and the pushing member are relatively moved, so that the coiled body is rotated while the tubular body is rotated. Indwelling items can be sent out. Thereby, the indwelling object is indwelled with high precision along the lumen wall of the treatment site. As a result, the living body lumen is reinforced by the action of the living body lumen and the indwelling indwelling object, and it is possible to effectively suppress or prevent the enlargement of the aneurysm.

In this case, it is preferable that an advancing / retracting mechanism for relatively moving the pushing member and the tubular body to move forward and backward is provided in the vicinity of the rotating mechanism.

Thus, by providing the advance / retreat mechanism near the rotation mechanism, the surgeon can easily operate the rotation of the tube by the rotation mechanism and the relative movement of the tube by the push member.

The advancing / retracting mechanism supports the rotating mechanism on the base end side of the rotating mechanism, and the axial center of the push-out member is aligned with the axial center of the tubular body at least at the proximal end portion of the tubular body. It is preferable to feed the extruded member.

Thus, the stent delivery device can easily insert the extruded member into the tubular body and move it forward by feeding the extruded member so that the axial center of the extruded member follows the axial center of the tubular body. That is, even if the tube is rotated about the axis by the rotation mechanism, the pushing member can move stably without being entangled, and the coiled indwelling object can be pushed out smoothly.

Further, the rotating mechanism has a rotating portion that rotates together with the tube, and a driving force for moving the pushing member and the tube relatively forward and backward is provided between the rotating portion and the advance / retract mechanism. A transmission unit that transmits the rotation unit to rotate the rotation unit may be provided.

Thus, the stent delivery device transmits the driving force for the transmission part to move forward and backward relative to the pushing member and the tube to the rotating part, so that the stent delivery device can rotate the pipe by the turning mechanism and push the pushing by the turning mechanism. The movement of the member can be performed by the same operation. Thereby, it becomes possible to expand the indwelling object more smoothly.

Here, the tubular body has a trunk portion extending substantially linearly, and a tip spiral portion formed in a spiral shape connected to the tip end side of the trunk portion, and on the tip surface of the tip spiral portion In addition, it is preferable that an opening through which the indwelling object can be delivered is formed in the lumen.

As described above, the stent delivery device has a spiral spiral formed continuously with the distal end side of the body portion so that the stent delivery device can deliver the coiled indwelling object from the opening of the spiral spiral portion rotated by the rotation mechanism. The indwelling object can be brought into close contact with the lumen wall of the living body lumen with higher accuracy.

In this case, the tube body can insert a guide wire introduced into the living body lumen so that the guide wire can advance and retreat, and the distal spiral portion is deformed along the guide wire in the insertion state of the guide wire, It can be set as the structure which returns to the predetermined spiral shape with the detachment | leave of the said guide wire.

Thus, the distal end spiral portion is deformed as the guide wire is inserted and removed, so that the stent delivery device is smoothly guided along the guide wire during delivery of the tubular body. In addition, the indwelling object can be developed with high accuracy by returning to a spiral shape at the treatment site.

1 is a partial side cross-sectional view showing an overall configuration of a stent delivery device according to an embodiment. 2A is an explanatory view showing a coil stent placed in the abdominal aorta by the stent delivery device of FIG. 1, FIG. 2B is an enlarged perspective view showing the coil stent of FIG. 2A, and FIG. 2B is a cross-sectional view of a 2B coil stent, and FIG. 2D is an enlarged perspective view of a coil stent according to another configuration example. 3A is a side sectional view showing a part of a tube of the stent delivery device of FIG. 1, FIG. 3B is a sectional view taken along line IIIB-IIIB of FIG. 3A, and FIG. 3C is a stent delivery according to another configuration example. FIG. 6 is a side cross-sectional view showing a portion of a tube of a device. 4A is a side view showing a state where a guide wire is inserted into the tube of FIG. 1, FIG. 4B is a side view showing a state where the guide wire is pulled out from the tube of FIG. 4A, and FIG. It is a side view which shows the relationship between the tube which concerns on the structural example, and a guiding catheter. It is a perspective view which shows the operating device of the stent delivery device of FIG. 6A is a plan view of the operating device of FIG. 5, and FIG. 6B is a cross-sectional plan view of the operating device of FIG. 7A is a side view of the operating device of FIG. 5, and FIG. 7B is a side cross-sectional view of the operating device of FIG. 8A is a first explanatory diagram for explaining the operation of the stent delivery device of FIG. 1, and FIG. 8B is a second explanatory diagram for explaining the operation of the stent delivery device of FIG. 9A is a third explanatory diagram for explaining the operation of the stent delivery device of FIG. 1, and FIG. 9B is a fourth explanatory diagram for explaining the operation of the stent delivery device of FIG. FIG. 10A is a plan view showing an operation device for a stent delivery device according to a first modification, and FIG. 10B is a partial side sectional view of the stent delivery device of FIG. 10A. It is a fragmentary sectional side view which shows the whole structure of the stent delivery device which concerns on a 2nd modification.

Hereinafter, preferred embodiments of the stent delivery device according to the present invention will be described in detail with reference to the accompanying drawings.

The stent delivery device 10 according to the present embodiment (hereinafter also simply referred to as the device 10) is used for a biological lumen interventional procedure. As shown in FIG. 1, this device 10 has a tube 12 that accommodates an indwelling object (stent) therein, and delivers the tube 12 to a treatment site via a blood vessel that is a living body lumen. It has a function of deploying and placing an indwelling object at a site. In particular, the device 10 is used for the treatment of abdominal aortic aneurysms.

As shown in FIG. 2A, an abdominal aortic aneurysm 100 (hereinafter also simply referred to as an aneurysm 100) includes, for example, an abdominal aorta 106 (hereinafter simply referred to as an artery) below the connection point of the renal artery 102 and above the common iliac artery 104. 106) and is formed in a spindle shape or a sac shape. The artery 106 is about 2 cm in diameter in a normal state where the aneurysm 100 is not generated, and when the artery 106 expands 1.5 times, that is, about 3 cm, it is determined that the aneurysm 100 has developed. Then, when the diameter of the aneurysm 100 is 4 cm or more, the risk of rupture is increased. For example, treatment such as artificial blood vessel replacement is performed.

The treatment of the device 10 according to the present embodiment is performed particularly from the initial stage to the middle stage of the aneurysm 100 (for example, the diameter is 2 to 4 cm). Specifically, the location where the aneurysm 100 is generated is reinforced by placing a coiled stent (coil stent 14) as an indwelling object along the blood vessel wall 108 in the artery 106. In the following description, the configuration of the coil stent 14 and the significance of application will be described in detail in order to facilitate understanding of the stent delivery device 10.

As the coil stent 14 placed in the aneurysm 100, for example, the one shown in FIG. 2B is applied. The axial length of the coil stent 14 is set longer than the formation range (axial length) of the aneurysm 100. The coil stent 14 is wound in a natural state where it is not indwelled in the blood vessel so that the spacing between the surrounding strands is relatively wide. Note that the number of turns of the coil stent 14 is not particularly limited, but it is preferable to use a coil stent that is wound three or more times so that the coil stent 14 is stably held in the aneurysm 100.

The diameter of the coil stent 14 is set larger than the diameter of the largest diameter portion of the aneurysm 100. Further, the elastic force of the coil stent 14 is set to be smaller than the elastic force of the blood vessel wall 108 and can be elastically deformed relatively easily. Therefore, when the coil stent 14 is deployed in the artery 106, the coil stent 14 is pushed inward by the blood vessel wall 108 to be elastically deformed, and is tightly held on the blood vessel wall 108 where the aneurysm 100 is formed (see FIG. 2A).

Here, the purpose of reinforcing the artery 106 with the coil stent 14 is to promote an immune reaction in the artery 106 by the indwelled coil stent 14 and to actively proliferate the intima of the blood vessel wall 108. That is, in general stent treatment, an indwelling material (for example, a stent coated with an immunosuppressive agent) that prevents intimal proliferation (stenosis) is applied, but the coil stent 14 used in this embodiment is immune. Suppression is not prohibited. As a result, the blood vessel wall 108 on which the coil stent 14 is placed acts to take in the coil stent 14 due to intimal proliferation and to thicken the blood vessel wall 108. As a result, the artery 106 is reinforced as a whole by increasing the thickness of the blood vessel wall 108 that has become thin due to the generation of the aneurysm 100 and by implanting the coil stent 14. Therefore, the expansion of the knob 100 is suppressed or prevented.

The coil stent 14 is preferably selected to promote an immune reaction when placed on the blood vessel wall 108, and is formed to have the above-described elastic force. The material of the wire 14a constituting the coil stent 14 is not particularly limited. For example, a pseudoelastic alloy (including a superelastic alloy) such as a Ni—Ti alloy, a shape memory alloy, stainless steel ( For example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc. And carbon-based materials (including piano wire). In particular, since the superelastic alloy is rich in flexibility and difficult to bend, the coil stent 14 is made of a superelastic alloy, so that a high followability to a curved or bent blood vessel or the like can be obtained. An excellent restoration property can be obtained when sending from 12. The preferred composition of the superelastic alloy is a Ni—Ti alloy such as a Ni—Ti alloy of 49 to 52 atomic% Ni, a Cu—Zn alloy of 38.5 to 41.5 wt% Zn, 1 to 10 wt% X Cu—Zn—X alloy (X is at least one of Be, Si, Sn, Al, and Ga), Ni-Al alloy of 36 to 38 atomic% Al, and the like. Of these, the Ni—Ti alloy is particularly preferable.

In this case, the coil stent 14 is preferably formed by applying deformation strain based on the transformation temperature of the material at the time of casting to obtain an elastic force that returns from a straight shape to a desired spiral shape. Of course, it is not limited to such a manufacturing method, For example, you may shape | mold from a linear strand to a coil shape by plastic deformation. Alternatively, the coil stent 14 is made of a material (for example, Ni—Ti alloy) whose shape is memorized thermomechanically, and is configured so that the restoration is promoted by applying predetermined heat from the living body. May be.

Further, the coil stent 14 is constituted by a wire 14a in which the corners 14b of the four corners are formed in an R shape and a substantially rectangular shape in a cross-sectional view (see FIG. 2C). That is, the coil stent 14 is formed by winding a long flat plate material (element wire 14a) spirally. Thereby, when the coil stent 14 is deployed in the artery 106, the outer surface side of the flat wire 14a can be brought into surface contact with the blood vessel wall 108, and the coil stent 14 can be easily brought into contact with the blood vessel wall 108. Can be detained.

Furthermore, the coil stent 14 is formed such that the distal end and the proximal end of the wire 14a are arcuate. As a result, the inconvenience of damaging the blood vessel wall 108 when the coil stent 14 is placed is suppressed.

In addition, the coil stent 14 is not limited to the above configuration, and can take various configurations. For example, as shown in FIG. 2D, the coil stent 15 in a natural state can be a spindle-shaped one having a larger diameter in the central portion in the axial direction than in the diameters at both ends in the axial direction. The coil stent 15 can be easily deployed along the aneurysm 100 formed in a spindle shape, and can contact the blood vessel wall 108 with a uniform elastic force.

The device 10 according to the present embodiment has a function of accurately placing the coil stent 14 configured as described above at a treatment site. Hereinafter, a configuration example of the device 10 will be specifically described.

1, the device 10 includes a catheter 16 that is mainly inserted into a living body, and an operation device 18 that is connected to the proximal end side of the catheter 16. The coil stent 14 is accommodated in the catheter 16 and delivered to the treatment site (aneurysm 100), and is expanded in the aneurysm under the operation of the operating device 18.

The catheter 16 has the tube 12 described above and a hub 20 connected to the proximal end side of the tube 12. The tube 12 is configured as a long and flexible tube that can follow a blood vessel. Inside the tube 12, two lumens (a guide wire lumen 22 and a housing lumen 24) are provided along the axial direction. The guide wire lumen 22 and the accommodation lumen 24 penetrate the tube 12 so that their axes are parallel to each other. That is, the catheter 16 according to the present embodiment is a double lumen type catheter.

The guide wire lumen 22 communicates with a wire delivery port 22 a formed on the distal end surface of the tube 12. A guide wire 26 (see FIGS. 3A and 3B) is inserted into the guide wire lumen 22 so as to freely advance and retract. The tube 12 is guided in the blood vessel along a guide wire 26 inserted into the guide wire lumen 22.

On the other hand, the accommodation lumen 24 (lumen) communicates with a stent delivery port 24 a formed on the distal end surface of the tube 12. The accommodation lumen 24 accommodates the coil stent 14 described above, and a pusher wire 28 (extrusion member) capable of extruding the coil stent 14 is inserted into the proximal end side of the coil stent 14.

The tube 12 includes a body portion 30 that is linearly formed from a base end portion to which the hub 20 is connected to a middle position on the distal end side, and a distal end spiral portion 32 that is continuous with the distal end side of the body portion 30 and has a spiral shape. And have. The body portion 30 constitutes a main portion of the tube 12 and extends linearly, whereby the coil stent 14 and the pusher wire 28 can be easily moved in the axial direction. The distal spiral portion 32 protrudes away from the axis O of the body portion 30 toward the oblique distal end side, and further circulates a predetermined length so as to wind an extension line of the axis O. The shape of the tip spiral portion 32 is brazed in advance.

As described above, the tube 12 is made of a material that has both flexibility that can follow a blood vessel and rigidity that can be accommodated by elastically deforming the coil stent 14 along the shape of the accommodation lumen 24. The material constituting the tube 12 is not particularly limited. For example, polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer (EVA), polyvinyl chloride, polyamide, acrylonitrile-butadiene-styrene. Polyester such as copolymer (ABS resin), acrylonitrile-styrene copolymer (AS resin), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycarbonate, polyimide, fluororesin, styrene, polyolefin, poly Various thermoplastic elastomers such as vinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluoro rubber, chlorinated polyethylene, polyurethane, etc. Copolymer to these main, blends, polymer alloys and the like, may be used in combination of two or more of these (e.g., a laminate of two or more layers). The tube 12 may be reinforced with a metal wire (blade) or the like.

The hub 20 connected to the proximal end side of the tube 12 is formed to have a larger diameter than the tube 12 so that the operator can easily grasp it. The surgeon grasps the hub 20 and performs a predetermined operation (advancing / retracting operation or rotating operation) to move the tube 12 relative to the blood vessel. In addition, although illustration is abbreviate | omitted, the wing etc. may be formed in the outer peripheral surface of the hub 20 so that the hub 20 may be operated easily.

Further, a hollow portion 34 communicating with the housing lumen 24 is formed in the hub 20 along the axial direction. A nozzle 46 of the operation device 18 to be described later is inserted into the hollow portion 34 so that the catheter 16 and the operation device 18 are integrated. Further, a port 36 that protrudes in the oblique proximal direction is provided on the outer peripheral surface of the hub 20. The port 36 functions as an input / output unit for the guide wire 26 and communicates with the guide wire lumen 22 via a passage (not shown).

On the other hand, the operating device 18 includes an advancing / retracting mechanism 38 for operating the push-out and pull-in of the pusher wire 28 and a rotating mechanism 40 for operating the rotation of the catheter 16. The advancing / retracting mechanism 38 includes a casing 42 that is formed in a cylindrical shape and has a relatively large appearance as compared with the hub 20, and the pusher wire 28 is accommodated inside the casing 42. The pusher wire 28 moves forward and backward based on the operation of the operation unit 44 (see FIG. 5) provided on the side of the housing 42.

The rotation mechanism 40 is provided near the tip of the cylindrical housing 42 and on the upper side, and has a function of rotating the catheter 16 around the axis of the catheter 16 (tube 12). The rotating mechanism 40 includes a nozzle 46 (rotating unit) to which the hub 20 of the catheter 16 is connected, and the operator rotates the nozzle 46 to rotate the catheter 16 around the axis.

The nozzle 46 can send out and pull in the pusher wire 28 from its tip, and the pusher wire 28 delivered from the nozzle 46 is inserted into the housing lumen 24 of the tube 12 through the cavity 34. The nozzle 46 is connected to the hub 20 so that the pusher wire 28 and the axis of the catheter 16 coincide with each other.

The pusher wire 28 is a solid bar member for extruding the coil stent 14 and is longer than the catheter 16 and is inserted into the receiving lumen 24 so as to advance and retract as shown in FIGS. 1 and 3A. . The distal end of the pusher wire 28 is formed as an extruded portion 48 that is thicker than the proximal-side wire body 28 a, and the extruded portion 48 has a distal flat portion 48 a that contacts the proximal end portion of the coil stent 14. As a result, the pusher wire 28 can easily contact the coil stent 14 and directly transmit the force at the time of advance movement.

Note that the pusher wire 28 is not limited to the above configuration, and for example, the pusher wire 29 shown in FIG. 3C may be applied. The pusher wire 29 has a cup-shaped extruded portion 49 having a concave portion 49a formed in the central portion, and the extruded portion 49 is connected to the wire body 29a on the proximal end side via a rotary connecting portion 49b. Yes. The recessed portion 49a of the pushing portion 49 inserts and holds the proximal end of the coil stent 14. The rotation connection part 49b supports the extrusion part 49 rotatably with respect to the wire main body 29a. Thereby, the pusher wire 29 can rotate the pushing portion 49 and transmit the advance movement force with the rotation of the tube 12.

The pusher wire 28 preferably satisfies the rigidity capable of pushing the coil stent 14 in the axial direction and the flexibility capable of following the curvature of the tube 12 and the like. The material constituting the pusher wire 28 is not particularly limited. For example, stainless steel, Ni—Ti alloy, Cu—Zn alloy, Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, tantalum, etc. And various high-molecular materials such as polyamide, polyimide, ultrahigh molecular weight polyethylene, polypropylene, and fluorine resin, or a combination of these appropriately.

Here, the tube 12 of the catheter 16 accommodates the coil stent 14 and the pusher wire 28 side by side in the axial direction, and the coil stent 14 and the pusher wire 28 can be smoothly moved relative to each other. Specifically, as shown in FIG. 3B, the guide wire lumen 22 is formed in a circular cross section, whereas the accommodating lumen 24 is formed in an elliptical cross section. The coil stent 14 composed of the flat element wire 14 a is accommodated such that the longitudinal side thereof coincides with the major axis side of the accommodating lumen 24 having an elliptical cross section. As a result, the contact of the coil stent 14 with the inner wall 24b constituting the housing lumen 24 is suppressed, and the coil stent 14 is easily moved relatively. On the other hand, since the pusher wire 28 does not rotate with the rotation of the tube 12, the cross section is preferably circular, and further, the pusher wire 28 preferably has a diameter slightly shorter than the short axis of the housing lumen 24 having an elliptical cross section.

4A and 4B, the device 10 according to the present embodiment is configured such that the shape of the distal end spiral portion 32 of the tube 12 is deformed by a guide wire 26 inserted into the guide wire lumen 22. ing. That is, the distal spiral portion 32 is deformed into a substantially linear shape shown in FIG. 4A by the guide wire 26 in a state where the guide wire 26 penetrates the tube 12 and is exposed from the wire delivery port 22a. Therefore, the tube 12 is easily delivered even in a thin blood vessel under the guide action of the guide wire 26. Of course, the tube 12 can be deformed along the shape of the guide wire 26 even if the guide wire 26 curves following the meandering blood vessel.

Then, for example, when the guide wire 26 is retracted from the distal spiral portion 32 at the treatment site, the tube 12 is restored to the spiral shape shown in FIG. 4B. At this time, a part of the coil stent 14 housed in the housing lumen 24 of the distal spiral portion 32 is deformed following the distal spiral portion 32. Therefore, the tube 12 can deliver the coil stent 14 in a direction different from that of the body portion 30.

In addition, the deformation | transformation of the front-end | tip spiral part 32 at the time of delivery of the tube 12 can take various means irrespective of the guide wire 26. FIG. For example, as shown in FIG. 4C, the distal end spiral portion 32 is deformed into a substantially linear shape by accommodating the tube 12 in the guiding catheter 27, and the distal end spiral portion 32 is spirally formed with the exposure from the guiding catheter 27. May be restored.

The device 10 can deliver the inside of the blood vessel in a state where the catheter 16 and the operation device 18 are separated, so that the operator can easily operate with the hub 20 of the catheter 16. Then, after the distal end of the catheter 16 reaches the treatment site, the operating device 18 is connected to the hub 20 and the pusher wire 28 is advanced from the operating device 18 so that the coil stent 14 is deployed in the blood vessel. Therefore, the operating device 18 is configured to accommodate a long pusher wire 28 and perform smooth delivery. Note that the device 10 may deliver the catheter 16 in the assembled state of the catheter 16 and the operation device 18, thereby eliminating the work of assembling the device 10 during the procedure.

As described above, the operating device 18 includes the advance / retreat mechanism 38 and the rotation mechanism 40. As shown in FIGS. 5, 6A, 6B, 7A, and 7B, the advance / retreat mechanism 38 includes the casing 42 and the operation unit 44 described above, and a rotating body 50 that holds the pusher wire 28 inside the casing 42. And a shaft portion 52 that protrudes outward along the axial center of the rotating body 50 and is connected to the operation portion 44.

The housing 42 includes a hollow portion 42a formed therein with a relatively large inner diameter. The hollow portion 42a has one end surface in the axial direction (the operation portion 44 side) closed by the wall portion 43 and the other end surface in the axial direction opened. The rotating body 50 is accommodated in the hollow portion 42 a so as to substantially coincide with the axis of the housing 42.

A rotation receiving groove 54 formed as a groove having a semicircular cross section parallel to the axial direction is provided at a predetermined position on the outer peripheral surface of the housing 42 (a position slightly deviated from the axial center). The nozzle 46 described above is partially accommodated in the rotation receiving groove 54.

The rotating body 50 has an outer diameter slightly smaller than the inner diameter of the hollow portion 42a, and is accommodated in a substantially non-contact manner on the inner surface constituting the hollow portion 42a. A winding groove 50a having a width capable of accommodating the pusher wire 28 is spirally formed on the outer peripheral surface of the rotating body 50, and the interval between the winding grooves 50a adjacent in the axial direction is set uniformly. Yes. The pusher wire 28 is wound along the winding groove 50 a and is housed in the housing 42 together with the rotating body 50. The rotating body 50 rotates in the direction opposite to the winding direction of the pusher wire 28 to separate the pusher wire 28 from the winding groove 50a, and rotates in the winding direction so that the pusher wire 28 is turned into the winding groove 50a. Contain.

A shaft hole 50b is formed through the shaft center of the rotator 50. The shaft portion 52 is inserted from one end surface of the rotator 50 and the fixing screw 51 is screwed from the other end surface. And the shaft portion 52 are connected. The shaft portion 52 extends from the end surface of the rotating body 50 along the axial direction of the rotating body 50, passes through the wall portion 43, and protrudes outside the housing 42. The operation portion 44 described above is connected to the protruding end portion of the shaft portion 52.

Further, a male screw part 58 is formed on the outer peripheral surface of the shaft part 52, and this male screw part 58 engages with a female screw part 60 of a central hole 43 a formed in the wall part 43. The interval between the screw grooves constituting the male screw portion 58 is set to substantially coincide with the interval between the adjacent winding grooves 50 a of the rotating body 50. Accordingly, when the shaft portion 52 makes one round along the engagement of the male screw portion 58 and the female screw portion 60, the shaft portion 52 is shifted in the axial direction by one screw groove, and thereby the winding groove 50a is also adjacent. Shift to the winding groove 50a. Therefore, the point where the pusher wire 28 is separated from the rotating body 50 constantly faces the nozzle 46 (leading path 46a).

The operation unit 44 includes a disc body 62 that is connected to the shaft portion 52 and has a predetermined thickness, and a handle 64 that protrudes outward from the plane of the disc body 62. An anti-slip grip 62 a is wound around the outer peripheral surface of the disc body 62 so that the operator can easily grip it. The handle 64 is provided at a position shifted from the central portion of the disc body 62, whereby the disc body 62 can be easily rotated clockwise or counterclockwise. That is, the operation unit 44 can rotate the rotating body 50 via the shaft portion 52 when the operator rotates either the disk body 62 or the handle 64, and for example, the pusher wire 28 is desired to be sent out largely. In this case, the handle 64 can be operated, and the pusher wire 28 can be selectively sent, for example, by operating the disk body 62 when it is desired to send the pusher wire 28 small.

On the other hand, the rotation mechanism 40 includes the rotation receiving groove 54 provided in the housing 42 and the nozzle 46 that is rotatably accommodated in the rotation receiving groove 54. The nozzle 46 has a lead-out path 46a formed penetrating in the axial direction. In addition, the axis of the nozzle 46 intersects with the axis of the casing 42, the rotating body 50, and the shaft portion 52 in a plane view (see FIG. 6A) in a direction orthogonal thereto, and the side view of the rotating body 50 (see FIG. 7B). It attaches to the housing | casing 42 so that it may become a tangent of an outer peripheral surface. Therefore, the nozzle 46 can output the pusher wire 28 that is separated when the rotating body 50 rotates in a straight line as it is.

The nozzle 46 has a disk-shaped rotation operation portion 66 and a protruding cylinder portion 68 that is connected to the center portion of the rotation operation portion 66 and protrudes a predetermined amount toward the tip side. The rotation operation portion 66 has a disk shape having an outer diameter that substantially matches the curvature of the semicircular rotation receiving groove 54 and is almost half filled in the rotation receiving groove 54 as it is accommodated. Therefore, the rotation operation portion 66 is exposed approximately half from the rotation receiving groove 54, and the operator rotates the exposed portion to rotate the entire nozzle 46.

As shown in FIG. 7B, a retaining pin 54 a is inserted into the rotation receiving groove 54 from the direction opposite to the rotation operation portion 66 in a state where the rotation operation portion 66 is accommodated in the rotation receiving groove 54. The retaining pin 54 a is inserted into an annular groove 66 a formed on one surface of the rotation operation unit 66. As a result, the nozzle 46 is prevented from dropping from the housing 42, and the rotation of the rotation operation portion 66 is guided by the retaining pin 54a during the rotation operation.

The protruding cylinder portion 68 has a connecting portion 68 a that protrudes in the distal direction from the base portion connected to the rotation operation portion 66 and is connected to the catheter 16. The outer peripheral surface of the connecting portion 68a is formed in a tapered shape that tapers in the distal direction, and is easily fitted into the cavity portion 34 of the hub 20. At the tip of the projecting cylinder portion 68, a lead-out port 69 that communicates with the lead-out path 46 a and feeds the pusher wire 28 to the cavity portion 34 is provided.

The rotation mechanism 40 can rotate independently of the pusher wire 28 being sent and pulled by the advance / retreat mechanism 38. On the contrary, the nozzle 46 can be rotated when the pusher wire 28 is delivered and retracted, whereby the distal end spiral portion 32 of the catheter 16 delivers the coil stent 14 while rotating in the circumferential direction of the blood vessel wall 108 at the treatment site. The operation is performed.

The device 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.

As described above, the device 10 is used for an interventional procedure in the early stage (or middle stage) of the abdominal aortic aneurysm 100. In the procedure, a guide wire 26 is introduced in advance from the patient's buttocks by, for example, the Seldinger method, and the catheter 16 having the guide wire 26 inserted into the guide wire lumen 22 is inserted into the living body. The guide wire 26 and the catheter 16 are delivered to the abdominal aorta 106 as shown in FIG. 8A via the blood vessel (the common iliac artery 104). At the time of delivery of the catheter 16, X-ray imaging is performed so that the positions of the guide wire 26 and the coil stent 14 can be visually confirmed.

Also, the catheter 16 is easily delivered into the blood vessel as the distal spiral portion 32 is elastically deformed into a shape along the guide wire 26. Delivery of the catheter 16 is stopped at a predetermined position where the distal end portion of the catheter 16 passes over the aneurysm 100 and overlaps the proxy malneck (healthy site) above the aneurysm 100.

After delivering the catheter 16 to a predetermined position, the guide wire 26 is moved backward and pulled out from the catheter 16. Thereby, as shown to FIG. 8B, the front-end | tip spiral part 32 is elastically returned to the spiral shape which is the original shape in a proxy malneck.

After pulling out the guide wire 26, the device 10 is assembled by connecting the operating device 18 to the catheter 16. With this assembly, the pusher wire 28 of the operating device 18 is inserted into the receiving lumen 24 of the tube 12 from the cavity 34 of the hub 20. Then, the pusher wire 28 is sent out from the nozzle 46 by rotating the handle 64 of the operating device 18 to rotate the rotating body 50, so that the push-out portion 48 advances in the housing lumen 24. When the pushing portion 48 reaches the proximal end portion of the coil stent 14 inserted in the accommodation lumen 24, the distal flat surface portion 48a comes into contact. Thereby, the coil stent 14 can be pushed out along the axial direction of the tube 12.

Thereafter, the device 10 delivers the coil stent 14 from the stent delivery port 24a as shown in FIG. 9A under the operation of the operator. When the coil stent 14 is delivered, the distal spiral portion 32 is rotated while the device 10 is moved backward relative to the artery 106. That is, the surgeon rotates the operation unit 44 of the advance / retreat mechanism 38 and rotates the rotation operation unit 66 of the rotation mechanism 40. As described above, since the rotation mechanism 40 is provided in the casing 42 of the advance / retreat mechanism 38 (that is, in the vicinity of the advance / retreat mechanism 38), the operator can rotate the nozzle 46 with his / her finger while holding the casing 42. The advance / retreat mechanism 38 and the rotation mechanism 40 can be operated without difficulty. Then, if the operating device 18 is pulled slowly, the catheter 16 moves backward along the artery 106, so that the distal spiral portion 32 moves backward while rotating and smoothly deploys the coil stent 14. be able to.

Thereby, the coil stent 14 is delivered from the device 10 while rotating around the axis, and elastically returns to the coil shape with this delivery. In this case, first, the proximal neck blood vessel wall 108 is deployed so that the outer peripheral surface of the coil stent 14 is in surface contact, and the distal spiral portion 32 is retracted to sequentially develop the aneurysm 100 side. As described above, the coil stent 14 has an outer diameter larger than the inner diameter of the aneurysm 100 and an elastic force smaller than the elastic force of the blood vessel wall 108, so that the coil stent 14 is expanded while being pushed inward by the blood vessel wall 108. Go. Thereby, the outer peripheral surface of the coil stent 14 adheres along the shape of the aneurysm 100 (the blood vessel wall 108).

As shown in FIG. 9B, when the device 10 is moved backward while rotating and reaches the lower distal neck (healthy site) through the knob 100, all the coil stents 14 accommodated in the device 10 are deployed. . Thereby, the coil stent 14 is indwelled with respect to the treatment site, and the catheter procedure is completed by withdrawing the device 10 from the living body.

After the treatment, the coil stent 14 is placed in contact with the blood vessel wall 108 of the aneurysm 100 (treatment site) (see FIG. 2A). For this reason, in the artery 106, an immune reaction is promoted over time, and the intima of the aneurysm 100 is proliferated to act to constrict the artery 106, and the coil stent 14 is taken into the blood vessel wall 108. . As a result, the aneurysm 100 is reinforced by the coil stent 14 while the vessel wall 108 becomes thick.

As described above, according to the device 10 according to the present embodiment, the tube 12 includes the rotation mechanism 40 that can rotate the tube 12 around the axis of the tube 12 when the tube 12 and the pusher wire 28 are relatively moved. The coil stent 14 can be delivered while rotating 12. As a result, the coil stent 14 is delivered so as to be closely adhered along the blood vessel wall 108 of the aneurysm 100. Therefore, the artery 106 is reinforced by the intima proliferation due to immune action and the indwelling coil stent 14, and the expansion of the aneurysm 100 can be effectively suppressed or prevented.

Further, the operating device 18 can send out the pusher wire 28 so that the axis of the pusher wire 28 is along the axis of the tube 12, and the pusher wire 28 can be easily inserted into the tube 12 and moved forward. Can do. That is, even when the catheter 16 is rotated around the axis by the rotation mechanism 40, the pusher wire 28 can be stably moved without being entangled, and the coil stent 14 can be pushed out smoothly.

Further, the distal spiral portion 32 is deformed as the guide wire 26 is inserted and withdrawn (removed), so that the distal end spiral portion 32 is smoothly guided along the guide wire 26 when the tube 12 is delivered, and exhibits a spiral shape at the treatment site. Thus, the coil stent 14 can be deployed with high accuracy.

It should be noted that the device 10 according to the present embodiment is not limited to the above-described embodiment, and can of course have various configurations. Hereinafter, some modified examples of the stent delivery device will be described. In the following description, the same reference numerals are given to the same configuration or the same function as the device 10 according to the present embodiment, and the detailed description thereof is omitted.

[First Modification]
The stent delivery device 10A according to the first modification shown in FIGS. 10A and 10B (hereinafter also simply referred to as device 10A) has a configuration in which the advance / retreat mechanism 38 and the rotation mechanism 40 of the operating device 18A are interlocked with each other. Thus, it is different from the device 10 according to the present embodiment. That is, the operating device 18 </ b> A includes a transmission mechanism 70 (a transmission unit) that transmits a mutual rotational force between the shaft portion 52 of the advance / retreat mechanism 38 and the nozzle 46 of the rotation mechanism 40.

For example, the transmission mechanism 70 is provided inside the housing 42, and has a rotating gear 72 that rotates by engaging with the irregularities (screw threads and thread grooves) of the male screw portion 58 of the shaft portion 52, and one end portion of the transmission mechanism 70. A rotating shaft member 74 that meshes with the rotating gear 72 and has the other end projecting toward the nozzle 46 and a continuous gear 76 that is integrally formed with the base end of the nozzle 46 are provided. The rotating gear 72 has an axial center at a position shifted from the shaft portion 52 and is rotatably accommodated in the wall portion 43, and can rotate as the shaft portion 52 rotates. The rotating shaft member 74 includes a first meshing portion 74 a that meshes with the rotating gear 72, a shaft 74 b that extends parallel to the axis of the rotating body 50, and a second meshing portion 74 c that meshes with the continuous gear 76. When the rotational force of the male threaded portion 58 is transmitted to the first meshing portion 74a via the rotary gear 72, the rotary shaft member 74 rotates the second meshing portion 74c via the shaft 74b, thereby connecting the continuous gear. 76 is rotated.

That is, the transmission mechanism 70 can rotate the nozzle 46 around the axis by transmitting the rotational operation force of the operation unit 44 to the nozzle 46. Therefore, the surgeon can rotate the operation unit 44 of the operation device 18A to perform the forward / backward movement of the pusher wire 28 and the rotation of the catheter 16 about the axis at the same time, thereby further easily operating the device 10A. be able to. In particular, the transmission mechanism 70 adjusts the rotation amount of the nozzle 46 and the rotation amount of the rotating body 50 to transmit the rotational force, so that the rotation amount of the catheter 16 and the delivery amount of the pusher wire 28 can be appropriately matched. Thus, the coil stent 14 can be deployed more smoothly.

Note that the transmission mechanism 70 is not limited to the above-described configuration, and various configurations that can mechanically or electrically interlock the advance / retreat mechanism 38 and the rotation mechanism 40 may be employed. Alternatively, the forward / backward mechanism 38 may be operated (the pusher wire 28 is fed and retracted) by rotating the nozzle 46 side of the rotating mechanism 40.

[Second Modification]
A stent delivery device 10B according to a second modification shown in FIG. 11 (hereinafter also simply referred to as device 10B) includes an operation device 18B that moves the catheter 16 backward relative to the pusher wire 28 with the pusher wire 28 as a fixed side. This is different from the

devices

10 and 10A according to the present embodiment and the first modification.

The operating device 18B includes an inner cylinder 80 connected to the hub 20 and an outer cylinder 82 having a guide hole portion 84 that can accommodate the inner cylinder 80 so as to be able to advance and retreat. The inner cylinder 80 projects outward in the radial direction at an extended cylinder part 80a having a predetermined length (a length substantially equal to the length of the wire 14a of the coil stent 14) and a proximal end part of the extended cylinder part 80a. And a flange portion 80b.

On the other hand, a spiral guide groove 84b for guiding the flange portion 80b is formed in the inner wall 84a constituting the guide hole portion 84 of the outer cylinder 82. Therefore, the outer cylinder 82 can be accommodated (advanced and retracted) in the guide hole 84 while rotating the inner cylinder 80. A pusher wire 28 is fixed to the bottom of the outer cylinder 82 and extends linearly.

Therefore, the device 10 </ b> B is configured such that when the operator holds the outer cylinder 82 and fixes the inner cylinder 80 and rotates the inner cylinder 80 in a predetermined direction, the inner cylinder 80 is accommodated in the guide hole portion 84 of the outer cylinder 82. Move backwards. Therefore, the catheter 16 connected to the inner cylinder 80 moves backward while rotating. That is, the operating device 18B has a configuration in which the rotating mechanism and the operating mechanism are integrally provided by the inner cylinder 80 and the outer cylinder 82.

The pusher wire 28 fixed to the outer cylinder 82 can push out the coil stent 14 by the catheter 16 retracting (relative movement). As a result, the distal end spiral portion 32 of the catheter 16 can move backward while rotating in the aneurysm 100 to deliver the coil stent 14. Therefore, the device 10B can obtain the same effect as the device 10.

In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

Claims

A tubular body (12) provided with a lumen (24) capable of being delivered in a living body lumen and containing a coiled indwelling object (14) placed in the living body lumen so as to be movable back and forth;
An extruding member (28) that is housed in the lumen (24) and pushes the indwelling object (14) out of the tube (12) by moving relative to the tube (12);
The tubular body (12) is connected to the proximal end side of the tubular body (12), and the tubular body (12) is arranged around the axial center of the tubular body (12) when the tubular body (12) and the pushing member (28) are relatively moved. A stent delivery device (10, 10A, 10B) comprising a rotatable rotation mechanism (40).
The stent delivery device (10, 10A) according to claim 1,
A stent delivery device (10) characterized in that an advancing / retracting mechanism (38) for moving the pushing member (28) and the tubular body (12) relative to each other is provided at a position in the vicinity of the rotating mechanism (40). 10A).
The stent delivery device (10, 10A) according to claim 2,
The advance / retreat mechanism (38) supports the rotation mechanism (40) on the proximal end side of the rotation mechanism (40), and at least the shaft of the push-out member (28) at the proximal end portion of the tube body (12). The stent delivery device (10, 10A), wherein the push member (28) is delivered so that the center is along the axial center of the tube (12).
The stent delivery device (10A) according to claim 2,
The rotating mechanism (40) has a rotating part (46) that rotates integrally with the tubular body (12),
Between the rotating part (46) and the advancing / retracting mechanism (38), a driving force for moving the pushing member (28) and the tubular body (12) relative to each other is applied to the rotating part (46). The stent delivery device (10A) is provided with a transmission portion (70) that transmits the rotation portion to the rotation portion (46).
The stent delivery device (10, 10A, 10B) according to any one of claims 1 to 4,
The tubular body (12) has a body part (30) extending substantially linearly, and a front end spiral part (32) formed in a spiral shape connected to the front end side of the body part (30),
The stent delivery device (10) is characterized in that an opening (24a) is formed on the distal end surface of the distal spiral portion (32) so as to be able to deliver the indwelling object (14) to the lumen (24). 10A, 10B).
The stent delivery device (10, 10A, 10B) according to claim 5,
The tube body (12) is capable of inserting a guide wire (26) introduced into the living body lumen so as to freely advance and retract.
The tip spiral portion (32) is deformed along the guide wire (26) in the inserted state of the guide wire (26), and returns to a predetermined spiral shape with the detachment of the guide wire (26). A stent delivery device (10, 10A, 10B).