JPH08196623A - Prosthetic material for atrial septal defect and catheter for obstructing atrial septal defect hole by using the repairing material - Google Patents

Abstract

PURPOSE: To provide a prosthetic material by which a defect site of a patient with atrial septal defect is fixed firmly and permanently by transdermal translumen catheter method, and also provide a catheter for obstructing the atrial septal defect hole of small or intermediate extent with the repairing materiel by means of a simple means. CONSTITUTION: A prosthetic material for atrial septal defect is composed of at least two of punctured fixing members 1 which are punctured at rim of septal membrane 21 of atrial septal defect site and can fix the above rim, a board-shaped member 5 for obstructing the atrial septal defect site, and a thread-like material 3 which is attached with the punctured fixing member 1 and penetrates into the board-shaped member 5. The punctured fixing member 1 is a deformable U-shaped metal fitting composed of puncture needles whose both ends are pointed, and the bottom metal fitting of the U-shaped metal fitting is provided with a small hole 6 through which the thread-like material 3 can be inserted.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an atrial septal defect prosthesis and a catheter for closing the atrial septal defect hole using the prosthesis. The present invention relates to a prosthesis for an atrial septal defect to be occluded by a percutaneous transluminal catheter method and a catheter for occluding an atrial septal defect hole using the prosthesis.

[0002]

2. Description of the Related Art King and Mill first reported a clinical success in 1976 as a method for occluding an atrial septal defect with a percutaneous transluminal catheter method. The method is to insert two disc-shaped umbrellas for the left and right atrium into the atrium with an insertion tool consisting of a central wire and a coaxial two-layer catheter, and sandwich the atrial septum. To close the atrial septal defect. However, this method was quite unusable for most children, especially preschool children, due to the very large insertion tool and stiff umbrella. Raskind strives to miniaturize the device,
In 1977, he reported a successful clinical case in children considering a single umbrella closure with a hook. However, this closure often catches on an unintended part due to hooking, and once opened in the heart, the position cannot be changed or recovered, and an emergency operation must be performed. To that end, Raschint has developed a two-piece, one-piece umbrella closure, which has been widely clinically applied to the closure of patent ductus arteriosus.

On the other hand, Locke added a coil spring to the middle of each of the eight stainless steel bones of the umbrella-type umbrella closure with two umbrellas developed by Rashkint, and the two umbrellas were thin in the atrium. A clam-type septum umbrella that firmly holds the gap was developed and a patent application (Japanese Patent Laid-Open No. 5-237128) was filed. This occluder is designed to be firmly fixed to the thin atrial septum by making two umbrellas adhere to each other so that they overlap each other. Since its shape resembles a clam, which is a bivalve, it is a claw septum. It is called an umbrella. Since this method inserts a 11F long sheath through the femoral vein, it can be used by patients with a body weight of 8 kg or more. A percutaneous transluminal catheter with atrial septal defect is used.
It is the first method that has been widely applied clinically as a method for occluding with the tell method.

[0004]

However, when this occluding material is left in the living body for a while, the hinges of the bones made of stainless steel of the umbrella and the arms of the stanchions are cut by stress reduction or fatigue in the living body. It was discovered that the trial was suspended in the US and Japan. In addition, this type of occluding material cannot be placed so that its center coincides with the central portion of the atrial septal defect hole, and in most cases, it is unevenly distributed, so it is an obstruction that is twice the size of the defect hole to be closed. There is a drawback in that the material is required, and the amount of the bone made of stainless steel is increased accordingly. The present invention has been made to remedy these drawbacks. It is an object of the present invention to provide a prosthesis that can firmly and permanently fix a defect site of a patient having an atrial septal defect to the atrial septum by a percutaneous transluminal catheter method. Another object of the present invention is to provide a catheter for closing a small to medium atrial septal defect hole with a prosthesis by a simple means.

[0005]

That is, according to the present invention, at least two puncture fixing members capable of puncturing the edge of the septum at the atrial septal defect and fixing the edge and the atrial septal defect are provided. In a prosthesis material for an atrial septal defect comprising a flat plate member for closing and a thread attached to the puncture fixing member and inserted through the flat plate member, the puncture fixing member consists of a puncture needle with sharp ends. It is a deformable U-shaped metal fitting, and is a prosthetic material for an atrial septal defect in which a small hole through which a thread is inserted is provided in a bottom metal fitting of the U-shaped metal fitting.
Further, the present invention provides the prosthesis for an atrial septal defect, wherein the flat plate-shaped member is a knitted woven fabric or a non-woven fabric made of a filamentous material of a biocompatible material. Furthermore, the present invention provides the prosthesis for an atrial septal defect, wherein the flat plate-shaped member is provided with a frame around the prosthesis. Furthermore, the present invention provides a puncture fixing member for puncturing and fixing to the edge of the septum at the atrial septal defect, and a flat member through which the thread attached to the puncture fixing member is inserted from the tip opening. Of the atrial septal defect with the main lumen in which the pushing member is inserted and the wall that passes through the atrial septal defect hole and contacts the inner wall of the septum of the atrial septal defect and forms the tip opening of the main lumen. The atrial septal defect hole consisting of a first sub-lumen having a holding member for pinching the edge of the diaphragm and bending a side fitting of the puncture fixing member penetrating the diaphragm is inserted. It is a category for. Also,
The present invention provides a catheter for closing the atrial septal defect hole, wherein the rod-shaped member having a flexible tip is inserted into a second sub-lumen formed in the wall of the main lumen. It is a catheter for closing the septal defect hole.

[0006]

In order to occlude the atrial septal defect using the prosthesis of the present invention, for example, a tube having a small diameter as shown in JP-A-3-195533 is replaced with a tube having a gradually increasing diameter. Then, a large-diameter fistula is formed. After that, a long-cavity catheter 7 is inserted into the lumen of the maximum-diameter catheter placed in the fistula, the catheter is made to reach the heart from the femoral vein, and an image is obtained by projection to obtain an atrial septal defect. Check the position, size and number of. Further, an ultrasonic tomography apparatus is inserted into the esophagus or into the lumen of the long lumen catheter 7 to confirm the position of the atrial septal defect and the like.

Next, the distal end of the long cavity catheter 7 shown in FIG. 3 is placed at the position of the atrial septal defect, and the puncture fixing member operating catheter 8 having the puncture fixing member 1 at the tip is attached to the long cavity catheter. -Insert into the lumen of Tel 7. Then, the pressing member 12 is extended from the tip of the catheter 8 for operating the puncture fixing member, and the pressing member 12 is placed inside the atrial septal defect. Then, the pressing member 12 presses the diaphragm 21, and the puncture fixing member 1 is pushed by the pushing member 16 and reaches the diaphragm 21. When the pushing member 16 is further pushed, the puncture fixing member 1 punctures the septum 21 of the atrial septal defect, and the holding member 12 bends both side metal fittings 29 of the U-shaped metal fitting inward, so that the puncture fixing material 1 is the atrium. It is fixed to the septum 21 with a septal defect. One end of the thread 3 is inserted through a small hole 6 formed in the bottom fitting 29 of the puncture fixing member 1 and fixed as a knot.

After the four puncture-fixing members 1 shown in FIG. 1 puncture the edges of the septum 21 of the atrial septal defect by operating the pushing member 16, respectively, the filaments 3 attached to the four puncture-fixing members 1 are attached. The other end is inserted into the small hole 19 of the annular recess 17 attached to the flat plate member 5 shown in FIG. 2, and the flat plate member 5 is pushed up to the diaphragm 21 of the atrial septal defect by the pushing member 16. Next, the pushing member 16 is attached to the catheter 8 for operating the puncture fixing member.
The filaments 3 are pulled out, the filaments 3 are inserted into the small holes 20 of the ridges 18 while the filaments 3 are pulled, and the ridges 18 are slid along the filaments 3 by the gripping members respectively. Annular recess 17
By fitting or screwing with, the flat plate-shaped member 5
The atrial septal defect diaphragm 21 is fixed, and the flat plate-like member 5 closes the atrial septal defect hole. Finally, a cutter having a scissor-like tip is introduced into the inner cavity of the long cavity catheter 8 and the extra filament 3 is cut to complete the atrial septal defect occlusion operation.

[0009]

EXAMPLES An example of the present invention will be described below with reference to examples. FIG.
FIG. 2 is a diagram for explaining an example of the prosthesis of the present invention, and FIG. 2 is an explanatory diagram when one of the puncture fixing members of the prosthesis of FIG. 1 punctures the septal edge of the atrial septal defect, FIG. 3 is an explanatory view showing an example of a puncture fixing member operating catheter in which the puncture fixing member is inserted in the tip, and FIGS. 4 and 5 are puncture fixing member operating catheters in which the puncture fixing member is inserted in the tip. FIG. 6 is an explanatory view showing another embodiment of the tel, and FIG. 6 is an explanatory view showing another embodiment when the puncture fixing member punctures the diaphragm edge of the atrial septal defect. In the figure, 1 is a puncture fixing member, 2 is a frame, 3 is a filamentous material, 4 is a penetrating portion, 5 is a flat plate member, 6 is a small hole of the puncture fixing member, 7 is a long cavity catheter, and 8 is a puncture. A fixing member operating catheter, 9 is a first sub-lumen, 10 is a main lumen, 12 is a pushing member, 17 is an annular recess, 18 is a ridge, 21 is a diaphragm, and 22 is a second sub-lumen. Show.

FIG. 1 is a view for explaining an example of a prosthesis material of the present invention, in which four puncture fixing members are provided on a substantially circular flat plate member 5 having a ring-shaped frame 2 on the periphery. 1 and the four thread-like objects 3 respectively inserted through the penetrating portion 4,
The puncture fixing member 1 is suspended in the small hole 6. One end of the thread 3 is fixed through a small hole 6 formed in the bottom metal fitting 28 of the puncture fixing member 1 with a knot or a fastener, and the other end of the thread 3 is fixed on the flat member 5. The penetrating portion 4 or the vicinity thereof is inserted to extend to the outlet of the insertion port of the long cavity catheter 7. Then, after the puncture fixing member 1 is punctured and fixed to the diaphragm 21 at the atrial septal defect site, the flat plate member 5 is moved toward the puncture fixing member 1 by the pushing member 16, and the flat plate member 5 is moved to the atrial septal defect. It is designed to close the hole. As a fixture for the flat plate member 5 and the puncture fixing member 1, a ridge portion 18 as shown in FIG. 2 is used, and is fitted or screwed into the annular recess 17 attached to the penetrating portion 4 of the flat plate member 5. By doing so, the movement of the filamentous material 3 is suppressed at the contact surface between the annular concave portion 17 and the protruding portion 18. As a result, the flat plate-shaped member 5 is attached to the puncture fixing member 1 fixed to the diaphragm 21 at the atrial septal defect site by the filamentous material 3, and closes the atrial septal defect hole.

In FIG. 1, the flat plate member 5 is provided with a frame 2 on the periphery thereof to facilitate attachment to the atrial septal defect hole. However, the periphery of the knitted fabric or nonwoven fabric is trimmed with sutures or the like. It can also be used. The size of the flat plate member 5 is at least 105% of the size of the atrial septal defect hole, preferably 110 to 15
It is 0%. FIG. 2 shows one of the puncture fixing members 1 of the prosthesis material of FIG.
FIG. 4 is an explanatory view showing an example when the end side of the septum 21 of the atrial septal defect is punctured and fixed, the end side of the septum 21 of the atrial septal defect is punctured by the puncture fixing member 1, and the side fitting 29 is placed inside. The diaphragm 21 is fixed by bending. As shown in FIG. 3, the puncture fixing member 1 is composed of a bottom metal fitting 28 and side metal fittings 29 extending from both ends thereof, and a small hole 6 through which the thread 3 is inserted is provided near the center of the bottom metal fitting 28. The one end of the thread 3 is fixed with a knot or the like. The thread 3 is inserted through the penetrating part 4 of the flat plate-like member 5 and the small hole 19 of the annular recess 17 mounted on the opposite surface of the flat plate-like member 5 of the penetrating part 4, the end of which is a long cavity catheter. 7 extends to the outlet of the insertion port. The ridge portion 18 in which the thread 3 is inserted into the small hole 20 is supplied to the annular recess 17 by the pressing member 16 and is screwed or fitted into the annular recess 17 so that the flat plate member 5 is prevented from having an atrial septal defect. It is attached to the diaphragm 21 to close the atrial septal defect hole.

As the flat plate member 5, polyester such as polyethylene terephthalate, polyethylene, polyolefin such as polypropylene, polyamide such as nylon 6 and nylon 66, fluorine such as polyethylene fluoride and polyvinylidene fluoride are used. Resin, chlorine-based resins such as polyvinyl chloride and polyvinylidene chloride, polyurethane, cellulosic semi-synthetic resins, knitted and woven fabrics, non-woven fabrics, films, and porous sheets made of biocompatible materials such as natural fibers and the like. And the like. Examples of the material of the frame 2 provided around the flat plate member 5 include metals, ceramics, synthetic resins and the like, and superelastic alloys such as Ni-Ti alloys and Cu-Al-Ni alloys are particularly preferable. Thread 3 and return thread
11 includes sutures or monofilaments made of biocompatible materials.

FIG. 3 is an explanatory view showing an example of the puncture fixing member operating catheter 8 having the puncture fixing member 1 attached to the tip thereof. The puncture fixing member operating catheter 8 is attached to the tip of the puncture fixing member 1. And thread 3 attached to the puncture fixing member 1
The flat member 5 through which the needle is inserted and the pushing member 16 for pushing out from the distal end opening 14 are passed through the main lumen 10 and the atrial septal defect hole, and the diaphragm 21 of the atrial septal defect. The end wall of the septum 21 with the atrial septal defect is sandwiched by the end wall portion 15 that contacts the inner wall of the main lumen 10 and forms the tip opening 14 of the main lumen 10, and the puncture fixation is performed by piercing the septum 21 with the atrial septal defect. It comprises a first sub-lumen 9 in which a holding member 12 for bending the side fitting 29 of the member 1 to fix the diaphragm 21 is inserted. The pressing member 12 is
The puncture fixing member 1 is composed of a head plate portion 13 for fixing the puncture fixing member 1 to the end edge of the septum 21 having an atrial septal defect, and a handle portion 11. The rear end of the handle portion 11 extends to the outlet of the insertion port of the long cavity catheter 8 and can slide and move inside the first sub-lumen 9. When the sharp puncture portion of the puncture fixing member 1 of the head plate portion 13 collides with the concave portion, the side metal fitting 29 of the puncture fixing member 1 bends inward and the septum 21 of the atrial septal defect is removed. It is preferable because it is firmly fixed. In FIG. 3, the pressing member 12 is L-shaped, but in this embodiment, the position for puncturing and fixing the puncture fixing member 1 to the septum 21 at the atrial septal defect is too close to the atrial septal defect. As a result, the puncture fixing member 1 may come off from the diaphragm 21. In that case, when the tip of the pressing member 12 is bent and used as shown in FIG. 5, the puncture fixing member 1 puncturing and fixing it to the diaphragm 21 does not come off from the diaphragm 21 of the atrial septal defect.

FIG. 4 is an explanatory view of the vicinity of the tip of another embodiment of the catheter 8 for operating the puncture fixing member, which has the puncture fixing member 1 in the inner cavity of the tip. Caterer 8 for operating the puncture fixing member
Is a flat plate-shaped member 5 having at least two puncture-fixing members 1 for puncture-fixing the distal end of the septum 21 with an atrial septal defect, and a thread 3 attached to the puncture-fixing member 1. The main lumen 10 in which the and are inserted, and through the atrial septal defect hole, contact the inner wall of the septum 21 of the atrial septal defect, the main lumen 10
The first sub-lumen 9 in which the pressing member 12 for sandwiching the edge of the septum 21 having the atrial septal defect is inserted with the distal end wall portion 15 forming the distal end opening 14 and the main internal cavity 10 are inserted. The puncture-fixing member 1 thus formed includes a second auxiliary lumen 22 into which a rod-shaped member 24 for pushing the puncture-fixing member operating catheter 8 forward from the tip opening 14 is inserted. The rod-shaped member 24 has a distal end that is inflexible and has a main lumen 10
It slides inside the second sub-lumen 22 formed in the wall of the. Second
It is preferable that the tip end opening 23 of the sub-lumen 22 is formed at a position inside the tip end opening 14 of the puncture fixing part operating catheter 8 at least the length of the puncture fixing member 1.

Examples of the inflexible member forming the tip of the rod-shaped member 24 include flexible materials such as metal such as soft iron and copper, ceramics and plastics. The end is pushed, and the puncture fixing member 1 is pushed out until it protrudes from the tip opening 14 of the puncture fixing member operating catheter 8 and is punctured and fixed to the septum 21 of the atrial septal defect. Most of the rod-shaped members 24 excluding the tip end are the puncture fixing member 1
It is used to push up and is preferably a rigid material such as metal, ceramic, plastic. After the first puncture fixing member 1 is punctured and fixed to the septum 21 at the atrial septal defect, the rod-shaped member 24 descends rearward, and its tip becomes straight and enters the second sub-lumen 22. The second puncture-fixing member 25 inserted into the main lumen 10 of the puncture-fixing member operating catheter 7 has its tip from the rear of the puncture-fixing member operating catheter 8 by, for example, another extruding member. It is pushed up until it reaches the tip opening 16 of the catheter 8 for operating the puncture fixing member. Next, a rod-shaped member 24 inside the second sub-lumen 22
By pushing the rod forward, the tip of the rod-shaped member 24 enters the main lumen 10 through the opening 23 of the second sub-lumen 22, the tip is bent, and the rear end of the second puncture fixing member 25 is fixed to the second puncture fixing. Element
It is pushed forward until 25 is punctured and fixed to the septum 21 of the atrial septal defect.

Although only two puncture fixing members are shown inside the main lumen 10 in FIG. 4, four puncture fixing members and one flat plate-like member 5 are inserted in advance and the puncture fixing members are sequentially arranged as described above. The operation is performed until the puncture is fixed to the septum 21 having the atrial septal defect. After the four puncture-fixing members are punctured and fixed to the septum 21 of the atrial septal defect, the flat plate-shaped member 5 disposed behind the last puncture-fixing member is pushed up and the distal end of the puncture-fixing member operating catheter 8 is pushed. Transfer from the opening 14 to the atrial septal defect. After that, the filaments 3 are inserted into the small holes 20 of the protrusions 18 while the filaments 3 are pulled from the outlet of the insertion port of the catheter 8 for operating the puncture fixing member, and the protrusions 18 are threaded by the gripping members. The filamentous material 3 is closed by sliding it along the object 3 and fitting or screwing it into the annular recess 17 attached to the flat plate-like member 5, and the flat plate-like member 5 ends at the end of the diaphragm 21 at the atrial septal defect. The plate-shaped member 5 is fixed to the edge and closes the atrial septal defect hole. Finally, a cutter with a scissor-like tip is introduced into the lumen of the long cavity catheter 7,
The operation of closing the atrial septal defect hole is completed by cutting the extra thread 3.

FIG. 6 is an explanatory view showing another embodiment when the puncture fixing member punctures the diaphragm edge of the atrial septal defect.
The bottom metal fitting 28 of the puncture fixing member 1 in which the septum 21 of the atrial septal defect is punctured and fixed is joined by the annular recess 31 attached to the flat plate-like member 33 by the thread 3 so that the flat plate-like member 33 becomes the atrial septal defect hole. To block. The thread 3 is inserted through the penetrating portion 30 of the flat plate member 33 and the small hole 32 of the annular recess 31 mounted on the flat plate member 33, and one end thereof is inserted through the small hole 6 of the puncture fixing member 1 to form a knot. , And the other end extends to the outlet of the insertion port of the long cavity catheter 7. The flat plate member 33 is inserted from the main lumen 10 of the catheter 8 for operating the puncture fixing member to the position of the puncture fixing member 1 fixed to the septum 21 of the atrial septal defect by the pushing member. The puncture fixing member 1 and the flat plate member 33
The flat plate-shaped member 33
Is fixed to the diaphragm 21 at the atrial septal defect and closes the atrial septal defect hole.

[0018]

According to the prosthesis of the present invention, a flat plate member made of a human-compatible material is placed at the center of the atrial septal defect hole because the puncture fixing member grips and closes the atrial septal defect. As a result, there is no fear that the closure material that would occur when using a closure material in which two umbrellas are overlapped, such as a conventional prosthesis material, is displaced from the center of the atrial septal defect hole. Further, unlike the conventional prosthesis, it is not necessary to use a closing material having a size twice as large as that of the atrial septal defect hole, and the strut is not cut due to stress reduction or fatigue of stainless steel. Thus, the prosthesis can be firmly and permanently fixed to the atrial septum by the percutaneous transluminal catheter method at the defect site of the patient.

[Brief description of drawings]

FIG. 1 is a view for explaining an example of a prosthetic material of the present invention.

FIG. 2 is an explanatory view when one of the puncture fixing members of the prosthesis of FIG. 1 grips a diaphragm edge of an atrial septal defect.

FIG. 3 is an explanatory view showing an example of a puncture fixing member operating catheter having a puncture fixing member attached to the tip thereof.

FIG. 4 is an explanatory view showing another embodiment of a catheter for operating a puncture fixing part-shaped member having a puncture fixing member attached to the tip thereof.

FIG. 5 is an explanatory view showing another embodiment of the catheter for operating the puncture fixing part-shaped member having the puncture fixing member attached to the tip thereof.

FIG. 6 is an explanatory view showing another embodiment when the puncture fixing member punctures the diaphragm edge of the atrial septal defect.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Puncture fixing member 2 Frame 3 Filament 4 Penetration part 5, 33 Flat plate member 6 Small hole of puncture fixing member 7 Long cavity catheter 8 Catheter for puncture fixing member operation 9 First sub-lumen 10 Main Lumen 12 Extruded member 17, 32 Annular recess 18 Streak 21 Septum of atrial septal defect 22 First sub-lumen

Claims (5)

[Claims] 1. A puncture fixing member that punctures an edge of a diaphragm at an atrial septal defect site and can fix the edge, and a flat plate-like member for closing the atrial septal defect site. In a prosthesis material for an atrial septal defect, which comprises a filament attached to the puncture-fixing member and inserted through the flat plate-shaped member, the puncture-fixing member is a deformable U-shaped metal fitting consisting of puncture needles with sharp ends. A prosthetic material for an atrial septal defect in which a small hole through which a thread is inserted is provided in a bottom metal part of the U-shaped metal fitting. 2. The atrial septal defect prosthesis material according to claim 1, wherein the flat plate member is a knitted woven fabric or a non-woven fabric made of a filamentous material of a biocompatible material. 3. The prosthesis material for an atrial septal defect according to claim 1, wherein the plate-shaped member is provided with a frame around the plate-shaped member. 4. A puncture-fixing member for puncturing and fixing the puncture-fixing member to the edge of the diaphragm at the atrial septal defect, and an extrusion for pushing out a flat plate-shaped member through which the thread attached to the puncture-fixing member is inserted from the tip opening. A septum of an atrial septal defect including a main lumen having a member inserted therein and a wall that passes through the atrial septal defect hole and is in contact with the inner wall of the septum of the atrial septal defect to form a tip opening of the main lumen. For closing the atrial septal defect hole formed of the first sub-internal cavity into which the pressing member for bending the side metal fitting of the puncture fixing member which pierces the diaphragm and is inserted Catel. 5. A catheter for occluding an atrial septal defect hole according to claim 4, wherein a rod-shaped member whose tip is bendable is inserted into a second sub-lumen formed in the wall of the main lumen. -Tel.