JP2000350785A - Stent (or stent graft) indwelling implement - Google Patents

Abstract

PROBLEM TO BE SOLVED: To safely and surely detain a stent (or a stent graft) even inside an extremely bent in vivo tubular body such as a blood vessel and reduce the pains and burdens of a patient. SOLUTION: This stent indwelling implement 10 is provided with a rigid dilator 2 comprising a main body part 2a, a stent holding part 2b and a head part 2c, and a sheath 3 for loading the dilator. In this case, the head part 2c is arranged to be partially protruded from an extremity of the sheath 3 so as to seal the extremity of the sheath 3 and an engaging means, such as a notch 2d, for engaging detachably a hook mounted on the stent is disposed at a part inside the sheath of the head part 2c. The part of the head part 2c protruded outwardly from the extremity of the sheath 3 is arranged to have a semi-elliptic or semi-spheric shape. One or a plurality of contrast medium injector channels 2e and a guide wire inductor channel 2g are disposed inside the dilator.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for securely placing a stent (or a stent-graft) at a safe site of an affected part in order to treat stenosis and dilatation of an artery (aneurysm) or other diseases. The present invention also relates to a stent (or stent graft) indwelling device that reduces pain and burden on a patient and reduces costs.

[0002]

2. Description of the Related Art Aneurysms caused by hardening or inflammation of arteries gradually expand when left untreated, resulting in a disease with a poor prognosis that leads to fatal rupture. So, in order to treat it,
Conventionally, surgical operations using an artificial blood vessel, such as an aneurysm resection operation and a replacement operation, have been used. However, since this disease is common in the elderly and frequently coexists with multiple organ disorders (brain, heart, kidney, etc.), and the surgical operation is often overly invasive, the surgical treatment for this disease is Surgery is limited to those that are safe to avoid these dangers. Therefore, the application of endovascular treatment using a sheath that is relatively invasive to surgery has attracted worldwide attention, and treatment with a stent (or a stent graft) is also expected as one of the applications.

[0003] A stent is an artificial tubular structure inserted into a tubular organ such as a blood vessel to support the tubular organ such as a blood vessel. For example, a stent is inserted into an internal tubular body such as a blood vessel, a gallbladder, an esophagus, an intestine, and a urethra when the internal tubular body is narrowed or deformed, and by supporting the internal tubular body, the stenosis or deformation is suppressed. To prevent. Stents widely used clinically for the treatment of arterial stenosis are
It is a cylindrical body formed by a net or a spring made of stainless steel or shape memory alloy (NiTi) wire. This tubular body can be repeatedly contracted and expanded in the radial direction. Further, the stent graft is formed by suturing and fixing a tubular body formed by a mesh or a spring made of stainless steel or nickel titanate wire as described above into an artificial blood vessel made of polyester or Teflon (registered trademark) (PTFE). This is a blood vessel-insertable artificial blood vessel. Stent grafts have been effectively used to treat aneurysms. Such a stent (or stent graft)
For example, JP-A-7-24072, JP-A-7-47
As described in JP-A-134, JP-A-7-500272, JP-A-8-299456, JP-A-8-502428 and JP-A-8-511487, it is well known in the art. Have been.

[0004] Such a stent (or stent graft)
Is indwelled in an affected part in a blood vessel via a catheter. That is, a stent (or a stent graft) is compressed to a diameter smaller than the inner diameter of a thin catheter, stored in the catheter, and inserted from an incision in a peripheral artery (mainly a femoral artery) to an affected area in a blood vessel. Therefore, a stent (or a stent graft) is pushed out from a catheter, radially expanded to a predetermined diameter, and placed in a diseased part in a blood vessel, thereby expanding an arterial stenosis lesion or closing an aneurysm, and simultaneously performing blood flow. Achieve reconstruction. Treatment with a stent (or stent-graft) reduces the burden on the patient because the surgical invasion is mild, and can be applied to aneurysm diseases that are not currently applicable. It has become a beneficial treatment for patients with stenotic and diastolic diseases.

[0005] In order to reliably close the aneurysm by placing the conventional stent graft, the conventional stent graft is placed over a wide area not only at the site of the aneurysm but also at the central and peripheral normal arteries. Therefore, it is necessary to ensure the close contact between this and the inner surface of the artery. At this time, the stent graft also blocks the main artery branching from the vicinity of the aneurysm, thereby causing organ damage (hereinafter referred to as “position "Abnormal"). For example, in the abdominal aorta, renal artery, inferior mesenteric artery, occlusion of arteries such as the internal iliac artery, renal impairment function and intestinal ischemic injury occur,
In the thoracic aorta, occlusion of the carotid or subclavian arteries may cause cerebral ischemia or impaired limb blood flow, and in the thoracic aorta, occlusion of the intercostal artery may result in spinal cord blood flow obstruction. This impaired spinal cord blood flow is a serious complication of lower body paralysis.

Accordingly, the present inventor has proposed a stent graft indwelling device capable of securely indwelling a stent (or a stent graft) at a safe site of an affected part (PC).
T / JP99 / 00824).

FIG. 6 is a partially cutaway side view of such a stent graft indwelling device. FIG. 6A shows a state in which the stent graft is surrounded and held by a number of guide wires and pushed out of a sheath. (b) shows a state in which the stent graft is surrounded by multiple guide lines and is to be pulled into the sheath, and (c) shows a state where the stent graft is surrounded and held in the sheath by multiple guide lines. It shows the state where it was done.

The stent graft indwelling device 110 includes a plurality of guide wires 101, a pushing rod 106 for arranging and holding the plurality of guide wires 101 in a circumferential direction, and a sheath 107 for loading the pushing rod 106. I have.

As shown in FIG. 6 (a), the stent graft 30 is circumferentially surrounded by a large number of guide wires 101, and as shown in FIG. 6 (b), a pushing rod extended outside the body via a sheath 107. The guide wire 106 is gradually pulled out of the body to draw the many guide wires 101 into the sheath 107, and the stent graft 130 is folded and compressed to a diameter smaller than the inner diameter of the sheath 107 as shown in FIG. As a result, it is stored in the sheath 107. The stent graft 130 may be stored in advance in the sheath 107 in such a procedure,
Immediately before use, it may be stored in the sheath 107.

[0010] The stent graft 130 (see FIG. 6 (c)) stored in the sheath 107 is inserted through an incision in the peripheral artery (mainly the femoral artery) along a guide wire to reach the affected part in the blood vessel, and then pushed. Pushing the distal end of the rod 106 pushes the stent graft 130 into the artery, expands and places the stent graft 130, thereby simultaneously achieving occlusion of the aneurysm and reconstruction of blood flow [FIGS. 6 (a) and 6 (b)].
reference]. At this time, if it is found from the video information that an unexpected situation such as an abnormal position of the stent graft 130 or an expansion failure has occurred, the stent graft is re-stored in the sheath 107 while the stent graft is converged by drawing the guide wire 101 [ See FIG. 6 (c)]. After the position of the sheath 107 is determined again, the stent graft 130 is placed and fixed in the aneurysm by the same procedure as described above.

As described above, according to the stent graft indwelling device 110 proposed by the present inventor, a safe site that avoids a dangerous site where blood flow obstruction or the like that occurs when the stent graft 130 is indwelled in a blood vessel is avoided. By finding in advance by video information, the stent graft 130 can be safely placed and fixed in the aneurysm.

[0012]

According to the stent (or stent-graft) indwelling device proposed by the present inventors, (a) when the stent (or stent-graft) is transported into an extremely bent artery, In such a case, the stent graft placement device cannot be used because serious complications such as damage may occur. (B) The stent graft is released to a predetermined site in the artery and expanded. And that the stent graft may be moved backward by the arterial blood flow and cannot be fixed at a predetermined site, and (c) the stent (or stent graft) stored in the substantially distal end portion of the sheath.
Since the positioning of the indwelling position is performed by discharging or re-storing the indentation position, there is a problem that it takes a long time to determine the indwelling position.

An object of the present invention is to solve such a problem. That is, the present invention provides a stent (or stent-graft) indwelling device that can safely and securely indwell a stent (or stent-graft) in an in-vivo tubular body such as an extremely bent blood vessel and also reduces the pain and burden on the patient. It is intended to be.

[0014]

According to the first aspect of the present invention, there is provided a rigid dilator comprising a main body, a stent (or stent graft) holding part and a head, and A stent (or stent graft) indwelling device comprising a sheath for loading the dilator, wherein the dilator head is provided so as to partially protrude from the distal end of the sheath so as to seal the distal end of the sheath. And an engaging means for detachably engaging a hook attached to the stent (or stent graft) with an inner portion of the sheath of the dilator head, the stent (or stent graft) indwelling device being provided. It is.

According to a second aspect of the present invention, in the first aspect, a dilator is provided with one or a plurality of contrast medium introduction channels and a die provided to protrude from the distal end of the sheath. The present invention is characterized in that one or a plurality of contrast medium discharge holes for discharging a contrast medium from a contrast medium introduction channel are provided in a surface portion of the head of the radiator.

According to a third aspect of the present invention, in the first or second aspect of the present invention, a guide wire guiding channel is provided on the dilator, and a guide wire insertion hole is provided at the tip of the dilator head. It is characterized by having.

According to a fourth aspect of the present invention, in the invention according to any one of the first to third aspects, the portion of the dilator head provided to protrude outside the distal end of the sheath has a semi-elliptical shape. Alternatively, it is characterized by being formed in a hemispherical shape.

According to a fifth aspect of the present invention, in the first aspect of the present invention, the engaging means is notched.

According to a sixth aspect of the present invention, in the first aspect of the present invention, the stent (or stent-graft) holding portion is provided so that the stent (or stent-graft) can be held on the surface thereof. And a diameter smaller than the diameter of the dilator body.

The invention described in claim 7 is the invention according to any one of claims 1 to 6, wherein the dilator is selected from (a) a fluorine-based resin, an acrylic resin, a polyolefin, a polyester, and a polyamide. It is characterized by being made of one kind of resin or (b) a reinforced plastic of the resin and a metal wire, glass fiber, carbon fiber or the like.

According to an eighth aspect of the present invention, in the first aspect of the present invention, the dilator operating portion attached to the rear end of the dilator and the flange provided at the rear end of the sheath are provided. A tubular sheath fixing member having a length substantially corresponding to the length of a stent (or a stent graft) is detachably fitted to cover the surface of the dilator body.

According to a ninth aspect of the present invention, in accordance with the first aspect of the present invention, the tubular sheath fixing member is provided with a longitudinally slit made of a flexible resin material. It is characterized by comprising.

The invention described in claim 10 is the first invention.
In the invention described in any one of the above (1) to (9), the stent (or the stent graft) in which the hook attached to the stent (or the stent graft) is engaged with the engagement means of the dilator head is used as the dilator stent (or the stent graft). And (2) holding the sheath in the vicinity of the distal end of the sheath.

[0024]

Embodiments of the present invention will be described below with reference to the drawings. 1A and 1B are stent graft indwelling showing one embodiment of the present invention, in which FIG. 1A is a partially broken side view, and FIG. 1B is an enlarged cross-sectional view taken along line AA of FIG. FIG. 4C is a perspective view of a sheath fixing member. 2A and 2B show a dilator according to an embodiment of the present invention, wherein FIG. 2A is a side view thereof, and FIG. 2B is a plan view thereof. FIG. 3 is an explanatory diagram showing a procedure for mounting a stent graft by the stent graft indwelling device according to one embodiment of the present invention,
(A) shows a stent graft, (b) shows a state where the stent graft is held by a stent graft holding part of a dilator and is stored in a sheath, (c) shows a state where the stent graft is released from the sheath, (D) shows a state in which the dilator is removed from the released stent graft. FIG. 4 is an enlarged side view of the stent. FIG. 5 is an enlarged side view of the stent graft.

As shown in FIGS. 1A and 1B, the stent graft indwelling device 10 of the present invention comprises a main body 2a,
A rigid dilator 10 comprising a stent graft holding portion 2b and a head portion 2c, and the dilator 1
0 is provided. The dilator head 2c is provided so as to partially protrude from the distal end of the sheath 3 so as to seal the distal end of the sheath 3, and a stent graft 3 is provided on the inner portion of the sheath of the dilator head 2c.
A notch (engaging means) 2d for detachably engaging the hook 14 (see FIG. 5) attached to the hook 0 is provided. Since the dilator 10 has rigidity, when a diseased part in a tubular body such as a blood vessel is present in a shallow place in the body, the stent graft can be placed without the guide wire 1 disposed in the body. The device 10 can be inserted into such an affected area. In the present embodiment, the notch 2d is provided as the engaging means, but a detachable engaging means other than the notch 2d may be provided as long as the object of the present invention is not violated.

As shown in FIG. 1B, the dilator 2
One or more contrast medium introduction channels 2e are provided in the dilator 2, and as shown in FIG. 1 (a), a surface portion of a dilator head 2c provided to protrude from the distal end of the sheath 3. One or a plurality of contrast medium discharge holes 2f for discharging the contrast medium from the contrast medium introduction channel 2e can be provided. Since the contrast medium introduction channel 2e and the contrast medium discharge port 2f are provided in the dilator 2, the dilator 2 is inserted into a body tubular body such as a blood vessel while discharging the contrast medium from the discharge hole 2f. The insertion position of the dilator head 2c can be grasped,
Moreover, by moving the dilator 2 back and forth while discharging the contrast agent from the discharge hole 2f of the contrast agent, it is possible to grasp in a short time a safe stent graft placement site in a diseased part in a tubular body such as a blood vessel, and the like. For the stent graft holding part 2 of the dilator 2
b, the stent-graft 3 stored in the sheath 3
Thus, the insertion into the in-vivo body such as a blood vessel and the positioning of the indwelling position of the stent graft 30 are safe and easy.

As shown in FIG. 1B, the dilator 2
And a guide wire insertion hole (not shown) can be provided at the tip of the dilator head 2c. When the dilator 2 has the guide wire guiding channel 2g and the guide wire insertion hole as described above, as shown in FIG.
The guide wire 1 placed in the body is passed through the guide wire guiding channel 2g from the tip through the guide wire insertion hole at the tip of the head of the dilator 2, and the stent graft indwelling device 10 is moved to the guide wire 1
The stent graft 30 can be safely, quickly and easily indwelled even if the diseased part exists deep inside the body, since the diseased part can be inserted into the diseased part inside the body tubular body such as a blood vessel while being guided by the blood vessel. be able to.

The dilator head 2c is a kind of valve that seals the distal end of the sheath 3 in order to prevent body fluids such as blood from entering the sheath 3. The portion of the dilator head 2c provided to protrude outside the tip of is formed, for example, in a semi-elliptical shape. As described above, when the dilator head 2c is formed in a semi-elliptical shape, the stent graft placement device 10 can be used to expand the inner wall of a body such as a blood vessel without damaging the inner wall of the body. It can be safely inserted into a body tubular body. In the present embodiment, the semi-ellipsoidal structure is shown as the portion of the dilator head 2c protruding outside the distal end of the sheath 3; May be another structure similar to an ellipsoid such as a spherical structure.

The portion of the dilator head 2c provided inside the distal end of the sheath 3 has a structure inclined toward the distal end so that the stent graft 30 can be easily released.
The dilator head 2c is connected to the stent graft holding portion 2b.
And the same resin as the dilator body 2a can be integrally molded therewith, but it can also be molded separately and fixed by extrapolating it strongly to the stent graft holding portion 2b. Alternatively, an adhesive may be used in combination.

As shown in FIGS. 2A and 2B, a notch (engagement) for detachably engaging a hook 14 (see FIG. 5) attached to the stent graft 30 is formed on the dilator head 2c. Means) 2d is provided. Since the notch 2d is provided in the dilator head 2c, the hook 14 is detachably engaged with the notch 2d, and the stent graft held by the stent graft holding portion 2b is positioned in a tubular body such as a blood vessel. Even when the stent graft 30 is pushed out of the sheath 3 at the indwelling position and self-expanded, the position of the stent graft 30 due to the pressure of the body fluid flow such as blood flow is prevented from moving. In the present embodiment, the notch 2d is shown as the engaging means, but a detachable engaging means other than the notch 2d can be applied as long as the object of the present invention is not violated.

As shown in FIGS. 1 (a), 2 (a) and 2 (b), the stent graft holding portion 2b has a diameter smaller than the diameter of the dilator body portion 2a such that the stent graft 30 can be held on its surface. So, stent graft 3
0 can be easily held in the stent graft holding portion 2b while being covered with the sheath 3. As described above, the stent graft holding portion 2b can be integrally molded using the same resin as the dilator main body portion 2a and the dilator head portion 2c. In this case, the portion to be the dilator head portion 2c, the stent graft holding portion 2b and the portion serving as the dilator main body 2a have the same diameter, and the portion serving as the inner portion of the sheath of the dilator head 2c and the portion serving as the stent graft holding portion 2b are ground to obtain the dilator head. The part 2c and the stent graft holding part 2b can be formed.

The dilator 2 is composed of
(A) One type of resin selected from a fluorine-based resin, an acrylic resin, a polyolefin, a polyester, and a polyamide; or (b) formed using a reinforced plastic of the resin and a metal wire, glass fiber, carbon fiber, or the like. Can be. Examples of the fluorine-based resin include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and tetrafluoroethylene-
Exafluoropropylene copolymer (FEP) and tetrafluoroethylene-polyethylene fluorovinyl ether copolymer (PFA). The constituent material of the dilator 2 may be a material other than the resin material as long as the purpose of the present invention is met.

As shown in FIG. 1C, a length corresponding to the length of the stent graft 30 was provided between the dilator operating section 5 attached to the rear end of the dilator and the flange 3a provided at the rear end of the sheath. The tubular sheath fixing member 4 can be detachably provided so as to cover the surface of the dilator body 2a. The tubular sheath fixing member 4 is made of, for example, a tubular body made of a flexible resin material provided with a slit 4a in the longitudinal direction, or a metal tubular member that can be opened and closed by a hinge in order to make it detachable. It may be composed of a body (not shown). Thus, the tubular sheath fixing member 4
Is provided so as to cover the surface of the dilator main body 2a, when the stent graft indwelling device is inserted into an in-vivo tubular body such as 10 blood vessels, the sheath 3 can be prevented from shifting backward.

As shown in FIGS. 1A and 3B,
The stent graft 30 in which the hook 14 attached to the stent graft 30 is engaged with the notch (engaging means) 2d of the dilator head is held in the stent graft holding portion 2b of the dilator 2, and the vicinity of the distal end of the sheath 3 The sheath 3 may be stored in advance in the vicinity of the distal end of the sheath 3 immediately before use.

Details of the stent used in the present invention are shown in FIG. When the stent 20 is expanded, its outer diameter is 20 to 40 mm, and its length is 30.
１００100 mm. The stent 20 has a plurality of (three in the figure) elastic rings 11 in which a zigzag bent metal wire is formed in an annular shape.
1 are arranged at intervals in the axial direction. Around the elastic ring 11, connection lines 12 are arranged at equal intervals in the circumferential direction, and these connection lines 12 are welded or brazed at intersections of the elastic rings 11. The elastic ring 11 and the connecting wire 12 are made of a rigid metal such as stainless steel, titanium, nickel titanate and the like. The metal wires have a diameter of about 0.4 to 0.8 mm. The distal end portion of the stent 20, that is, the bent portion 11a of the elastic ring 11
, A hook 14 formed of a metal wire is fixed by fixing means such as welding or brazing. The stent 20
These metal wires may be formed by a net (not shown).

Details of the stent graft 30 are shown in FIG. The stent graft 30 is made of a graft 13 (artificial blood vessel) made of polyester or Teflon (PTFE).
Insert the stent 20 as shown in FIG.
The graft 13 is formed by suturing and fixing the graft 13 to the elastic ring 11 with a thread (not shown) such as polypropylene.

Next, the operation of the stent graft of the present invention will be described with reference to FIG. (1) A stent graft 30 having a hook 14 formed of a metal wire fixed to a bent portion of the elastic ring 11 by welding as shown in FIG. 5 is prepared. [FIG. 3 (a)]

(2) After engaging the hook 14 of the stent graft 30 with the notch 2d of the dilator head 2c,
The stent graft 30 is held by the stent graft holding portion 2b provided between the dilator head 2c and the dilator main body, and then the sheath 3 is externally inserted from the distal end of the stent graft 30 held by the stent graft holding portion 2b. By compressing and compressing the stent graft 30 to a diameter smaller than the inner diameter of the sheath 3,
The stent graft 30 is stored in a substantially distal end portion of the sheath 3 while being held by the stent graft holding portion 2b of the dilator 2. A longitudinal slit 4a having a length corresponding to the length of the stent graft 30 may be provided between the dilator operating section 5 attached to the rear end of the dilator and the flange 3a provided at the rear end of the sheath. The tubular sheath fixing member 4 made of a flexible resin material is connected to the dilator body 2a.
(See FIGS. 1 (a) and 1 (c)) so as to removably fit from the slit 4a so as to cover the surface of the slit 4a. [FIG.
(B)]

(3) Guide wire 1 (FIG. 1)
(A), see FIG. 2) from the incision in the femoral artery, which is the peripheral artery of the thoracic aortic aneurysm,
It is installed so as to reach the incision in the brachial artery, and one end of the guide wire led out from the incision in the femoral artery is inserted into the guide wire insertion channel 2g through the guide wire insertion hole of the dilator head 2c (FIG. 1B). See)
The stent graft 30 housed in the sheath 3 while being guided by the guide wire 1 is inserted from the incised portion of the femoral artery while operating the dilator operation unit 5 provided at the rear end of the dilator, and inserted into the blood vessel. A safe part that avoids a dangerous part where blood flow obstruction or the like occurs in the affected part in the blood vessel by moving the catheter 2 back and forth while reaching the vicinity of the affected part and discharging the contrast agent from the discharge hole 4 of the contrast agent. Is grasped by an image, and the placement position of the stent graft 30 is determined. Subsequently, while the sheath fixing member 4 is removed and the dilator operating member 5 is fixed, the sheath 3 is attached to the dilator operating member 5 by the flange 3a.
Pull out until it comes into contact with the knob 5a of FIG.
(See (a), (c)), the stent graft 30 is released to the positioned indwelling position and expanded. [FIG.
(C)]

(4) The dilator 2 is pulled in the hand direction while fixing the sheath 3, and the notch (engaging means) of the dilator head 2 c by the hook 14 of the stent graft 30 released to the positioned indwelling position. After disengaging the 2d, the dilator head 2c is pulled out through the inner hole of the stent graft 30 to the distal end of the sheath 3, and the dilator head 2c is inserted into the substantially distal end of the sheath 3, The dilator 2 and the sheath 3 are both pulled out of the body. Subsequently, the guide wire 1 is pulled out of the body. [FIG. 3 (d)]

According to the stent graft indwelling device of the present invention, the stent graft can be indwelled in the in-vivo body such as a blood vessel by the above-described operation, so that the stent graft can be safely and reliably used in the in-vivo body such as an extremely bent blood vessel. At the same time, and at this time, the pain and burden on the patient can be reduced. In this way, by permanently placing the stent graft 30 in the affected part of the body tubular body such as a blood vessel, for example, it is possible to safely reconstruct blood flow while expanding an arterial stenosis lesion or closing an aneurysm.

Although the present embodiment has been described centering on the implementation relating to the stent graft 30, the stent 20 can be implemented in the same manner as the stent graft 30.

As described above, the present invention has the following advantages. I. A rigid dilator comprising a main body, a stent (or stent graft) holding part and a head, and
In a stent (or stent graft) indwelling device including a sheath for loading the dilator, the head of the dilator may be, for example, semi-ellipsoidal or hemispherical from the distal end of the sheath so as to seal the distal end of the sheath. Since the engaging means is provided so as to protrude partially in a body shape, and detachably engages a hook attached to a stent (or a stent graft) with the inner portion of the sheath of the dilator head. And the like can be prevented from penetrating into the stent graft (or stent graft) portion held in the sheath, and the stent (or stent graft) indwelling device can be inserted into a tubular body such as a blood vessel to damage the inner walls thereof. It can be safely introduced without doing.

B. One or more contrast medium introduction channels are provided in the dilator, and the contrast medium is discharged from the contrast medium introduction channel to a surface portion of the dilator head provided to protrude from the distal end of the sheath. Since one or more contrast medium discharge holes are provided, the insertion position of the dilator head is grasped by inserting the dilator into the body tubular body such as a blood vessel while discharging the contrast agent from the contrast medium discharge hole In addition, by moving the dilator back and forth while discharging the contrast agent from the discharge hole of the contrast agent, it is possible to grasp in a short time an image of a safe site in the affected part in the tubular body such as a blood vessel, For them, the stent (or stent graft) held in the stent (or stent graft) holding portion of the dilator and stored in the sheath is used. Positioning the indwelling position of the insertion and the stent into the body tubular body such as a blood vessel (or stent-graft) is safe and easy.

C. Since the engaging means such as a notch is provided in the inner portion of the sheath of the dilator head, a stent (or a stent graft) in which a hook is detachably engaged with the engaging means such as the notch can be connected to a tubular body such as a blood vessel. Even if the stent is pushed out of the sheath and self-expanded at the indwelling position positioned in the body, the position movement of the stent (or the stent graft) due to the pressure of the body fluid flow such as the blood flow can be prevented.

D. The stent (or stent-graft) holding portion is made smaller than the diameter of the dilator main body portion so that the stent (or stent-graft) holding portion can hold the stent (or stent-graft) on its surface. The part can be easily held.

E. A flexible member having a length corresponding to the length of a stent (or a stent graft) between the dilator operating portion attached to the rear end of the dilator and the flange provided at the rear end of the sheath, for example, a slit provided in the longitudinal direction. Since the tubular sheath fixing member made of a tubular body made of a conductive resin material is detachably provided so as to cover the surface of the dilator body, the stent (or stent graft) indwelling device is inserted into a tubular body such as a blood vessel. When doing so, it is possible to prevent the sheath from shifting backward.

[0048]

According to the present invention, (a) a stent (or a stent-graft) which can be safely and reliably placed in an in-vivo tubular body such as an extremely bent blood vessel and also reduces the pain and burden on a patient; (B) It is possible to provide an indwelling device, (b) prevent body fluids such as arterial blood from invading the stent graft portion held in the sheath, and attach the stent graft held in the sheath to a blood vessel. (C) Insertion of a catheter into a tubular body such as a blood vessel while discharging the contrast agent from a discharge hole of the contrast agent, which can be safely introduced into the tubular body such as an (artery) without damaging the inner walls thereof. By doing so, the insertion position of the catheter can be grasped from the image, and the catheter is discharged while the contrast medium is being discharged from the contrast medium discharge hole. By moving back and forth, it is possible to grasp in a short time an image of a safe site in a diseased part in a tubular body such as a blood vessel, and to insert the stent graft stored in the sheath into the tubular body such as a blood vessel. (D) Even if the stent graft is pushed out of the sheath and self-expanded at the positioned indwelling position in the body tubular body such as a blood vessel, even if the stent graft is self-expanded, the body fluid flow such as blood flow can be performed safely and easily. (E) conventional stent (or stent graft)
Can be applied to aneurysms, etc., which have been excluded from the application, and therefore, it is possible to provide an effective treatment for patients with many aneurysms, etc.

[Brief description of the drawings]

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a stent graft indwelling device showing one embodiment of the present invention, wherein (a) is a partially broken side view, and (b) is an enlarged cross-sectional view taken along line AA of (a). (C) is a perspective view of the sheath fixing member.

FIG. 2 is a dilator showing one embodiment of the present invention, (a) is a side view thereof, and (b)
Is a plan view of the same.

FIG. 3 is an explanatory view showing a procedure for mounting a stent graft by a stent graft indwelling device according to an embodiment of the present invention, wherein (a) shows a stent graft;
(B) shows a state in which the stent graft is held by the stent graft holding part of the dilator and stored in the sheath, (c) shows a state in which the stent graft is released from the sheath, and (d) shows a state in which the stent graft is released. The state where a dilator is removed from a stent graft is shown.

FIG. 4 is an enlarged side view of a stent.

FIG. 5 is an enlarged side view of a stent graft.

FIG. 6 is a partially cutaway side view of the stent graft indwelling device proposed by the present inventors, and (a) shows a state where the stent graft is surrounded and held by a number of guide wires and pushed out of a sheath, (b) shows a state in which the stent graft is surrounded by a number of guide wires and is to be pulled into the sheath, and (c) a state in which the stent graft is surrounded by a number of guide wires and held in the sheath. Is shown.

[Description of Signs] 1 Guide wire 2 Dilator 2a (Dilator) main body 2b Stent graft holding part 2c (Dilator) head 2d Notch 2e Contrast agent introduction channel 2f Contrast agent discharge hole 2g Guide wire guide channel 3 Sheath 3a flange 4 sheath fixing member 4a slit 5 dilator operating part 5a knob 5b entrance 10 stent graft indwelling device 11 elastic ring 11a bending part 12 connecting line 13 graft 14 hook 20 stent 30 stent graft

Claims (10)

[Claims] 1. A stent (or stent graft) indwelling device comprising a rigid dilator comprising a main body, a stent (or stent graft) holding portion and a head, and a sheath for loading the dilator. The dilator head is provided so as to partially protrude from the distal end of the sheath so as to seal the distal end of the sheath, and is attached to a stent (or a stent graft) at an inner portion of the sheath of the dilator head. A stent (or stent graft) indwelling device provided with an engaging means for detachably engaging the hook. 2. A dilator having one or more contrast medium introduction channels, and discharging a contrast medium from the contrast medium introduction channel to a surface portion of a dilator head provided so as to protrude from a distal end of a sheath. The stent (or stent graft) indwelling device according to claim 1, wherein one or a plurality of contrast medium ejection holes to be provided are provided. 3. The indwelling stent (or stent graft) according to claim 1, wherein a guide wire guiding channel is provided in the dilator, and a guide wire insertion hole is provided at a tip of the head of the dilator. apparatus. 4. The dilator according to claim 1, wherein a portion of the dilator head protruding outside the distal end of the sheath is formed in a semi-elliptical or hemispherical shape. Stent (or stent graft) placement device. 5. The stent (or stent graft) indwelling device according to claim 1, wherein the engaging means is notched. 6. The dilator body according to claim 1, wherein the stent (or stent graft) holding portion has a diameter smaller than the diameter of the dilator main body portion so that the stent (or stent graft) can be held on the surface thereof. The stent (or stent graft) indwelling device according to any one of the above. 7. A dilator comprising: (a) one kind of resin selected from a fluorine-based resin, an acrylic resin, a polyolefin, a polyester and a polyamide; or (b) a resin and a metal wire, glass fiber or carbon fiber or the like. The stent (or stent graft) indwelling device according to any one of claims 1 to 6, wherein the device is made of a reinforced plastic. 8. A tubular sheath fixing member having a length substantially equivalent to the length of a stent (or a stent graft) is provided between a dilator operating portion attached to the rear end of the dilator and a flange provided at the rear end of the sheath. The stent (or stent graft) indwelling device according to any one of claims 1 to 7, wherein the stent (or the stent graft) is in a detachably fitted state so as to cover the surface of the dilator main body. 9. The stent (or stent graft) indwelling apparatus according to claim 8, wherein the tubular sheath fixing member is formed of a tubular body made of a flexible resin material and provided with a slit in a longitudinal direction. 10. A stent (or a stent-graft) in which a hook attached to a stent (or a stent-graft) is engaged with an engaging means of a dilator head, is held by a stent (or a stent-graft) holding portion of the dilator. The stent (or stent graft) indwelling device according to any one of claims 1 to 9, wherein the stent (or stent graft) is stored in the vicinity of the distal end of the sheath.