JP2003235853A - Bloodstream cutoff instrument and bloodstream cutoff instrument with catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a dissociated aneurysm obturator in which surgical opera tion can be easily applied by reducing the invasion in comparison with the conventional operation and influence to other portions can be reduced by secur ing blood to the other artery by making occlusion local in comparison with conventional stent-based aneurysm occlusion. <P>SOLUTION: The bloodstream cutoff instrument is configured by having a bloodstream cutoff member formed from a wire-like object to form a flat spiral object vertically to a bloodstream when cutting off the bloodstream and a fixing member in which the bloodstream cutoff member can be fixed in the cutoff part of the bloodstream. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is applied to a therapeutic member suitable for blocking blood flow, particularly a blood vessel in which an aneurysm has occurred, for example, a dissecting aortic aneurysm affected area, and is a minimally invasive aneurysm. And a dissecting aortic aneurysm occluding device with a catheter. However, the blood flow blocker of the present invention is not limited to use as an aortic aneurysm occluding member, and blocks blood flow at other locations, for example, blocking of holes in ventricular septal defect or atrial septal defect. It is also effective for

[0002]

2. Description of the Related Art Due to changes in eating habits and the advent of an aging society, the number of surgical cases of dissecting aortic aneurysm has been increasing in recent years. Regarding the surgical results of this dissecting aortic aneurysm, the surgical results have been improving due to improvements in assisting means and surgical procedures. However, in some cases such as those shown below, the surgical results are poor, and sometimes surgery is performed. May be excluded from the adaptation of. For example, elderly patients with poor preoperative conditions, patients with severe heart, lung, and renal impairment. However, due to the size of the surgical invasion of the above patients, surgery and surgical treatment have to be abandoned, but the results of medical treatment in such cases are poor, and the development of other therapeutic methods that are less invasive Is waiting.

The intimal wall of the aorta causes an ulcer, the intimal wall causes an ulcer, and the intimal wall partially ruptures, from which blood flows into the wall of the aorta, causing the arterial wall to dissociate into two layers. A stent is placed at or near the intimal rupture part (hereinafter also referred to as the entry part), which is in a closed state, to block the blood flow from the entry part to the false cavity, thereby treating the aneurysm without surgery. What you do is disclosed. For example, the treatment method disclosed in Japanese Utility Model Publication No. 6-75413. This involves inserting a reduced stent (in the radial direction) into the catheter lumen, guiding the catheter introducer to the vascular lesion, and then slowly withdrawing the introducer to place the stent in the lumen of the blood vessel. It is a thing. However, with this method, the blood flow is blocked not only in the affected area of the aortic aneurysm but also in the vicinity and a wide range, so that there are not many applicable sites.

[0004]

DISCLOSURE OF THE INVENTION The present invention has a small surgical invasion and is capable of blocking blood flow by blocking blood flow only in the vicinity of a surgical site, and a blood flow blocker with a catheter, particularly An object of the present invention is to provide a dissociative aortic aneurysm obturator capable of blocking the blood flow from the true cavity side to the false cavity side of an aortic aneurysm affected area, and a dissociative aortic aneurysm obturator with a catheter.

[0005]

One of the main features of the present invention is a spiral or mosquito coil which is formed of a linear material and is flat in the direction perpendicular to the blood flow when the blood flow is interrupted. And a fixing member capable of fixing the blood flow blocking member to the blood flow blocking unit. The vertical direction with respect to the blood flow is not limited to the vertical direction, and may be inclined from the vertical direction as long as the angle is within a range in which the blood flow blocking effect is exerted. An example of the blood flow blocking member is a patch member 3 as shown in FIG. The patch-shaped member 3 is preferably flat. Note that the flat shape referred to here is not limited to a completely flat shape, and for example, as shown in FIG. 7, the blood flow blocking member is used to remove the blood flow B from the true cavity side to the false cavity side of the dissociative aortic aneurysm entry portion. When used for blocking, it means that the thickness is such that the flow of the blood flow A passing through the aorta 9 is not hindered, and if it does not hinder the flow of the blood flow A, it has a certain thickness in the axial direction. May be included. As the spiral of the true cavity side closing patch having a certain thickness in the axial direction as described above, for example, the axial front half forms a substantially flat spiral, and the axial rear half is What can form a shape that can be inserted in close contact with the inner wall of the true cavity side entry portion opening is preferable. The blood flow blocker with such a shape is
Not only the flat portion can effectively block the blood flow B from the true cavity side to the false cavity side, but also the axial rear half portion which is inserted in close contact with the inner wall of the true cavity side entry opening. Thus, the blood flow B from the true cavity side to the false cavity side can be more effectively blocked, and the blood flow B can be firmly attached to the entry portion.

The blood flow blocker is, for example, passed through a catheter to be carried to the entry portion of the dissecting aortic aneurysm, pushed out of the catheter at the entry portion, inflated vertically in the blood flow direction, and left in the catheter. It is possible to return to the shape of the spiral object before being subjected to the action, and to exert the function of blocking the flow of the blood flow from the true cavity side to the false cavity side. Therefore,
The blood flow blocking member of the blood flow blocking device of the present invention has a shape that, when placed outside the catheter from inside the catheter in which the blood flow blocking device is stored, substantially returns to the shape before being stored in the catheter. Those having a memory property are preferable. In order to impart the above-described shape memory property to the blood flow blocking member, the member is preferably made of a shape memory material such as a shape memory alloy or a shape memory plastic. However, the shape memory property of the blood flow blocking member is not limited to the case of using the shape memory material, and even if the shape memory material is not used, for example, the shape of the linear object forming the member or the rolled shape is devised. By doing so, the shape memory property as described above may be substantially exhibited.

The linear object constituting the blood flow blocking member is not limited to the one having a circular cross section, and may have a modified cross section other than the circular cross section. For example, by making the cross section of a linear object a flat rectangular shape,
It is possible to narrow the interval between the linear objects and the spiral objects or the mosquito coil incense-like objects, and it is possible to more effectively block the blood flow. Further, in order to improve the blood flow blocking function of the blood flow blocking member, at least a part of the periphery of the linear object forming the blood flow blocking member may be covered with a coating material. As such a covering means, for example, a means of covering at least a part of the periphery of the linear object with, for example, a cloth or winding it with another linear object can be mentioned.

As described above, the shape of the linear object forming the blood flow blocking member or the coating of the linear object by
The distance between the linear objects can be adjusted to effectively block the blood flow. Further, by covering at least the outside of the front surface of the blood flow blocking member with the elastic coating film, the blood flow can be prevented. It can be blocked more effectively. As such an elastic coating film, a material having elasticity capable of being deformed or expanded in the blood flow direction, for example, a woven fabric, a knitted fabric, a non-woven fabric, or a mesh-like material formed of an elastic material such as polyurethane or silicone rubber is used. The formed elastic coating film etc. are mentioned. In order to further improve the blood flow blocking function of the blood flow blocking device of the present invention, the blood flow blocking member, the coating material of the linear object forming the blood flow blocking member, and the elasticity coating the blood flow blocking member. More preferably, at least one of the coatings is treated with a thrombus formation promoting agent.

Unlike the blood flow blocking member, the fixing member of the blood flow blocking device of the present invention does not necessarily have the function of blocking the blood flow, and therefore has the function of holding the blood flow blocking device at the blood flow blocking site. If it is a thing, the fixing member of arbitrary structures can be used. As such a fixing member, for example, a fixing member which is closed in a state where it is housed in a catheter, but has a function of opening in a Y shape when it is placed outside the catheter at a blood flow blocking site and fixing to the false cavity side. There is a bar. However, the false cavity side fixing member is also made of a linear material like the blood flow blocking member, and can be stored in the catheter, and the catheter at the blood flow blocking portion from the state stored in the catheter. When placed outside, it is preferable that it has a shape memory property that forms a spiral in the axial direction or in the direction perpendicular to the blood flow and substantially returns to the shape before being housed in the catheter. . The shape memory property of the fixing member can be imparted in the same manner as the blood flow blocking member. When the fixing member of the blood flow blocker of the present invention is placed outside the catheter as described above, when the spiral member can be formed in the axial direction or in the direction perpendicular to the blood flow, it is referred to as a blood flow blocker. It can be composed of one continuous linear object.

Another main feature of the present invention is that in the above-described blood flow blocking device, the blood flow blocking member has a gripped portion at the tip opposite to the connecting portion of the fixing member, which can be gripped by the gripping member. To have. That is, the blood flow blocker of the present invention has a gripped portion of the blood flow blocking member that can be inserted into a catheter, and a gripping operation for gripping or gripping the gripped portion of the blood flow blocking member at the tip. With possible grippers, the following installation, recovery or re-installation operations could be made possible.

1. The blood flow blocker is housed in a catheter, the distal end of the catheter is inserted, for example, into the pseudocavity side part of the dissecting aortic aneurysm entry part, and the gripping tool is inserted into the catheter in this state, and the gripping tool is inserted. Grip the gripped part of the blood flow blocker and push the fixing member out of the catheter to fix the fixing member to the false cavity side part.Furthermore, while holding the gripped part of the blood flow blocker, hold the catheter at hand. The blood flow blocking member is placed outside the catheter at the true cavity side portion of the entry portion of the dissociative aortic aneurysm by pulling to the operation portion, and the blood flow blocking member is set in the true cavity side portion. When this setting is completed, the state in which the grasped portion of the blood flow blocker is grasped by the grasping tool is released, and the grasping tool can be easily separated and collected.

2. The blood flow blocker is installed at the blood flow block site as described in 1 above, but when the installed state is insufficient for blood flow block, the gripped part of the blood flow blocker of the installed blood flow blocker is held. Insert the catheter tip in the vicinity,
The grasping tool can be pushed out from the catheter tip, the grasped portion of the blood flow blocking member of the installed blood flow blocking tool can be grasped by the grasping tool, and can be easily collected in the catheter. Then, the collected blood flow blocker can be easily installed again at the blood flow block site as described in 1 above. If the blood flow blocker collected in the catheter as described above is inappropriate for re-installation, for example, if it is damaged or does not fit the shape of the blood flow block site, collect the blood flow blocker. Reinstalling a new blood flow blocker can be easily performed as described in 1 above. As described above, the blood flow blocker of the present invention has been constructed by combining a blood flow blocker provided with a portion to be gripped by a gripper, a gripper for gripping the member, and a catheter into which the gripper can be inserted. It was possible to achieve an excellent effect that could not be achieved by the blood flow blocker of.

Examples of the grasping tool include grasping forceps, biopsy forceps, and snares as shown in the drawings which are usually used in surgical operations and the like. In particular, the operation of collecting the blood flow blocker 2 can be performed more easily by using a gripping tool such as the high frequency snare. Further, the grasped portion grasped by these grasping tools may have, for example, a ring shape, a wicker shape, a spherical shape, or the like. The portion to be grasped, for example, a linear object constituting a blood flow blocking member is projected to the side grasped by the grasping member,
An example is one in which the tip portion is formed into the shape described above that can be held by a holding member.

The catheter preferably has a shape that can be easily inserted into the blood flow block site. Also,
As described in 1) and 2) Installation or collection operation of blood flow blocker, properly confirming the tip position of the catheter is to install or collect the blood flow blocker of the present invention at the blood flow block site. It is important when performing, and the state of the blood flow block site, for example, the size and depth of the opening of the entry portion of the dissecting aortic aneurysm is confirmed, and the blood flow block that matches the blood flow block site is selected. It is also important for In order to easily detect the position of the tip portion of the catheter, it is preferable to provide an X-ray marker portion on the tip portion of the catheter. Therefore, as shown in the figure, the catheter used in the present invention is an X-ray imaging unit. It is preferable that the composition can contain the agent, for example, the one having a branch pipe corresponding to the injection port.

As described above, by examining the condition of the entry part by the X-ray contrast method before the operation, it is possible to adopt a more appropriate dissecting aortic aneurysm obturator according to the condition of the entry part during the operation. Is preferred,
Therefore, for example, it is preferable to prepare a plurality of types of blood flow blockers having different spiral diameters between the blood flow block member and the fixing member and different intervals between the blood flow block member and the fixing member. Furthermore, corresponding to the plurality of types of blood flow blockers, the catheter and the gripping tool are also prepared in a plurality of types, and a suitable combination of these dissecting aortic aneurysm obturator, catheter and the gripping member is combined, The set one is more preferable.

The present invention will be described below with reference to the drawings. 1, the blood flow blocker is composed of a true cavity side closing patch 3 and a false cavity side fixing member 1 of a dissecting aortic aneurysm, and the true cavity side closing patch 3 is substantially formed by a linear object. It is a flat spiral or mosquito coil. The false cavity side fixing member 1 is also a flat spiral-shaped article formed of a linear article or a mosquito coiling incense article like the true cavity side closing patch 3. The true cavity side closing patch 3 and the false cavity side fixing member 1 are connected by a wire 2 which is a connecting member thereof. The blood flow blocker of FIG. 1 has a blood flow blocker indwelled therein, and a blood flow blocker, for example, a catheter tip is inserted into the false cavity side part of the entry part of the dissecting aortic aneurysm, The pseudo-lumen side fixing member 1 is pushed out of the catheter and expanded perpendicularly to the axial direction or the blood flow direction to be fixed to the pseudo-lumen side portion, and then the catheter is pulled back to the proximal operation section to enter the dissection aortic aneurysm entry section. At the true cavity side portion, the true cavity side closing patch 3 is placed outside the catheter from the catheter tip end portion and expanded vertically in the blood flow direction, so that the flow of the blood flow from the true cavity side portion to the false cavity side portion can be blocked.

The blood flow blocker of FIG. 2 is different from the blood flow blocker of FIG. 1 in that the blood flow blocker 3 is gripped by the gripper at the tip of the blood flow blocker 3 opposite to the connecting portion of the fixing member 4.
It is characterized by having. The grasped portion 4 is not limited to the one shown in this figure, and it is preferable to provide the patch for closing the true cavity side of the dissecting aortic aneurysm obturator according to another aspect.

FIG. 3 shows a blood flow blocking member 6 in which the axial front half a forms a spiral article which is substantially flat.
The axial rear half b has a shape that can be inserted in close contact with, for example, the inner wall of the entry opening of the dissecting aortic aneurysm. This figure is particularly excellent in the ability to block the flow of blood.

As described above, the blood flow blocking member of FIGS. 1 to 3 is excellent in the ability to block the flow of the blood stream by itself, but in order to further improve the performance of blocking the flow of the blood stream. As shown in FIG. 5, by covering at least the outer surface of the blood flow blocking member on the front surface in the blood flow direction with an elastic coating film, the flow of blood flowing in the gaps between the elastic members is suppressed and thrombus is formed. The blood flow can be effectively blocked.

FIG. 4 shows a state in which the blood flow blocking device of FIGS. 1 and 2 is housed in the catheter 7. Further, FIG. 6 shows a state in which the member to be grasped of the blood flow blocking member is grasped by the biopsy forceps and housed in the catheter 7.

[0021]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiment 1 The dissecting aortic aneurysm obturator of this embodiment has a structure as shown in FIG. The true cavity side closing patch and the false cavity side fixing member which are blood flow blocking members are flat in the axial direction and have a diameter of 0.5 to 1.2 mm or so. The spiral-shaped material or the mosquito coil-shaped material formed by the wire of 1), and the diameter thereof is preferably in the range of about 10 to 30 mm. The true cavity side closing patch and the false cavity side fixing member may be composed of one wire made of the shape memory alloy, or there is another wire made of the shape memory alloy. It may be connected by a wire. A wadder-shaped gripping member 4 is formed at the tip of the true cavity side closing patch.

Embodiment 2 The dissecting aortic aneurysm obturator of this embodiment has a structure as shown in FIG. The true cavity side closing patch, which is a blood flow blocking member, has an axial front half a having a flat shape and an axial rear half b bulging rearward in the axial direction so that it can be fitted into the entry portion. belongs to. The structure of the dissecting aortic aneurysm obturator according to this embodiment is the same as that according to Embodiment 1 except for the above-mentioned shape.

Embodiment 3 The dissecting aortic aneurysm obturator of the above-mentioned Embodiments 1 and 2 was housed in the following catheter to prepare a dissecting aortic aneurysm obturator with a catheter. A polyethylene catheter was used as the catheter. The length of the catheter is 125-
150 cm, the thickness of the catheter was 5-12 French. Examples of the material forming the catheter include polyurethane and polyamide in addition to the polyethylene.

[0024]

[Effect] By using the blood flow blocker of the present invention,
It is less invasive than conventional surgical methods, and the blood flow blocker can be easily installed, collected, and reinstalled at the blood flow block site. For example, in an occlusion operation using the blood flow blocker of the present invention as a dissecting aortic aneurysm blocker, it is easier to install at a surgical site and less invasive than surgery using a conventional blood flow blocker. Since local occlusion is sufficient, blood flow to other arteries can be secured, and the effect on other parts can be reduced. Furthermore, it is very easy to collect and re-install the blood flow blocker once installed.

[Brief description of drawings]

FIG. 1 is a diagram showing one embodiment of a blood flow blocker of the present invention.

FIG. 2 is a view showing a blood flow blocker in which a member to be grasped 4 that can be grasped by a biopsy forceps or the like is formed on the coupling member 2 of FIG.

FIG. 3 is a view showing an embodiment of another blood flow blocker of the present invention.

FIG. 4 is a view showing a state where the blood flow blocker of the present invention is housed in a catheter.

FIG. 5 is a view showing a blood flow blocker in which a blood flow block site of the blood flow blocker of FIGS. 1 and 2 is covered with an elastic coating film.

FIG. 6 shows a state in which a grasped member of a blood flow blocking member is grasped by biopsy forceps and housed in a catheter 7.

FIG. 7 is a view showing an installation state when the blood flow blocking member of the present invention is used for blocking blood flow B from the true cavity side to the false cavity side of the dissecting aortic aneurysm entry portion.

[Explanation of symbols]

1. Fixing member 2. Coupling member 3. Blood flow blocking member 4. Member to be grasped 5. Fixing member 6. Blood flow blocking member 7. Catheter 8. Elastic coating material 9. Aorta 10. Dissecting aortic aneurysm entry section 11. Dissociated aortic aneurysm pseudocavity side portion 12. Blood flow blocker 13. Fixing member 14. Blood flow blocking member 15. Aortic inlet 16. Hand operation unit 17. Seal portion 18. Seal portion 19. X-ray contrast agent inlet 20. Biopsy forceps 21. Catheter 22. Clamping portion of biopsy forceps 23. Blood flow blocker 24. X-ray contrast agent marker section A. Aortic flow B. Blood flow from the true lumen side to the false lumen side of the dissection aortic aneurysm entry site

Claims (14)

[Claims] 1. A blood flow blocking member which is formed of a linear material and is capable of forming a flat spiral member in a direction perpendicular to the blood flow when the blood flow is blocked, and the blood flow blocking member is a blood flow blocking portion. A blood flow blocker comprising at least a fixing member that can be fixed to the blood flow blocker. 2. The blood flow blocking member is a blood flow blocking member installed in a true cavity side portion that blocks blood flow from the true lumen side to the false lumen side of the dissecting aortic aneurysm entry portion, and the fixing member is dissociated. The blood flow blocker according to claim 1, wherein the blood flow blocker is fixed to the pseudo-cavity-side portion of the entry portion of the aortic aneurysm. 3. The blood flow blocking member, when blocking the blood flow,
The axial front half portion forms a substantially flat spiral-shaped object, and the axial rear half portion can form a shape that can be inserted in close contact with the true cavity side opening. Item 3. The blood flow blocker according to Item 1 or 2. 4. A shape in which the blood flow blocker can be housed in the catheter and can be substantially restored to the shape before being housed in the catheter when the blood flow blocker is placed outside the catheter from the state housed in the catheter. The blood flow blocker according to any one of claims 1 to 3, which has a memory characteristic. 5. The blood flow blocking device according to claim 4, wherein at least the blood flow blocking member is formed of a shape memory material. 6. The fixing member is composed of a blood flow blocking member and one continuous linear member, and when the blood flow is blocked, a spiral member can be formed in a direction perpendicular to the blood flow. And has a shape memory characteristic capable of being substantially restored to the shape before being accommodated in the catheter when placed outside the catheter from the state of being accommodated in the catheter. The blood flow blocker according to any one of claims 1 to 5. 7. The blood flow blocking device according to claim 1, wherein the blood flow blocking member is covered with an elastic coating film at least on the outside of the front surface thereof. 8. The blood according to claim 1, wherein the linear material constituting the blood flow blocking member is at least a part of the linear material coated with a coating material. Flow blocker. 9. A blood flow blocking member, at least one of a coating material for a linear material constituting the blood flow blocking member and an elastic coating film for coating the blood flow blocking member, which is treated with a thrombus formation promoting agent. The blood flow blocker according to any one of claims 1 to 8, wherein 10. The blood flow blocking member has a gripped member that can be gripped by a gripping tool at the tip opposite to the connecting portion of the fixing member, according to any one of claims 1 to 9. The blood flow blocker described. 11. The blood flow blocker according to any one of claims 1 to 10 and at least a catheter in which the blood flow blocker can be placed. Blood flow blocker with catheter. 12. The blood flow blocker with a catheter according to claim 11, further comprising a gripper capable of gripping a gripped member of the blood flow blocker. 13. The grasping tool is forceps (grasping forceps, biopsy forceps).
And / or a snare.
2. A blood flow blocker with a catheter according to 2. 14. The catheter according to claim 11, wherein when the catheter is introduced into a living body, an X-ray contrast agent for confirming the tip position of the catheter can be injected. The blood flow blocker with a catheter according to any one of 1.