JP3185907B2 - Prosthetic material for atrial septal defect and catheter for closing atrial septal defect hole using the prosthetic material - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

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

[0002]

2. Description of the Prior Art King and Mill reported a clinical success in 1976 for the first time in percutaneous transluminal catheterization of atrial septal defect. In this method, two disc-shaped umbrellas for the left and right atrium are brought to the atrium with an insertion tool consisting of a central wire and a coaxial two-layer catheter, sandwiching the atrial septum. To close the atrial septal defect. However, this method was unusable for most children, especially preschool children, due to the very thick insertion tool and hard umbrella. Rashkind worked to make the equipment smaller,
In 1977, he reported a case of successful clinical use in children, considering a single hooked umbrella-type closure plug. However, this closure plug often catches at an unintended part due to hooking, so that once the umbrella is opened in the heart, the position cannot be changed or recovered, and there is a problem that an emergency operation must be performed. To that end, Rashkind developed an integrated two-piece umbrella-type closure plug, which has been widely used in clinical applications in the closure of patent ductus arteriosus.

On the other hand, Locke adds a coil spring to the middle of each of the eight stainless steel bones of the two-piece umbrella closure umbrella developed by Rashkind, so that the two umbrellas are thin in the atrium. We have developed a clam-type septal umbrella that sandwiches the septum firmly and applied for a patent (Japanese Patent Laid-Open No. 5-237128). The occlusive material is fixed to the thin atrial septum by the close contact of two umbrellas so that they overlap each other. Since the shape is similar to the clam, which is a bivalve clam, the clam septum It is called an umbrella. This method can be used for patients weighing 8 kg or more because a long case of 11F is inserted through a femoral vein, and a percutaneous transluminal catheter with atrial septal defect can be used.
This is the first method widely used in clinical applications as a method of occluding by the Tel method.

[0004]

However, when this obstructing material is placed in the living body for a while, the hinge of the bone made of stainless steel of the umbrella or the arm of the strut is cut off due to a decrease in stress or fatigue in the living body. And the trial has been suspended in both the United States and Japan. In addition, this type of occlusion material cannot be placed so that the center of the occlusion coincides with the center of the atrial septal defect hole, and in most cases, it is unevenly distributed, so that the occlusion is twice as large as the defect hole to be closed. However, there is a disadvantage that the use of stainless steel and the use of bone are increased accordingly. The present invention has been made to remedy these drawbacks. SUMMARY OF THE INVENTION It is an object of the present invention to provide a prosthesis that can securely and permanently fix a defect site of a patient having an atrial septum defect to the atrial septum by a percutaneous transluminal catheter method. Another object of the present invention is to provide a catheter for closing small to medium atrial septal defect holes with a prosthetic material by simple means.

[0005]

That is, the present invention provides at least two puncturing members which can puncture and insert a septum at a site of atrial septal defect, a flat member for closing the atrial septal defect, A prosthetic material for an atrial septal defect, comprising a thread attached to a puncture member and penetrating the flat member. The present invention also relates to the prosthetic material for atrial septal defect, wherein the plate-shaped member is a knitted or woven fabric made of a thread-like material of a biocompatible material. Further, the present invention relates to the prosthetic material for atrial septal defect, wherein the plate-like member is provided with a frame around the prosthetic material.

Further, the present invention provides a puncture member for puncturing the end of the diaphragm at the point of atrial septal defect, and a flat member through which the puncture member and a thread attached to the puncture member are inserted. A main lumen in which an extruding member for extruding from the distal opening is inserted, and a wall that passes through the atrial septal defect hole, contacts the inner wall of the diaphragm of the atrial septal defect, and forms a distal opening of the main lumen. A catheter for closing an atrial septal defect hole comprising a first sub-lumen in which a pressing member for sandwiching an edge of a diaphragm of an atrial septal defect is inserted. Further, the present invention provides the catheter, wherein the extruded member formed of a rod-shaped member whose tip can be bent is inserted into a second sub-lumen formed in the wall of the main lumen. It is a catheter for blocking.

[0007]

In order to occlude an atrial septal defect using the prosthetic material of the present invention, for example, a small-diameter tube as disclosed in Japanese Patent Application Laid-Open No. 3-195533 is replaced with a tube having a progressively larger diameter. Then, a large diameter fistula is formed. Thereafter, a long lumen catheter is inserted into the lumen of the largest diameter catheter placed in the fistula, and the catheter is inserted into the lumen.
The ter is made to reach the heart from the femoral vein and the projection is imaged to determine the location, size and number of atrial septal defects.
Further, an ultrasonic tomography apparatus is inserted into the esophagus or the lumen of the long lumen catheter to confirm the position of the atrial septal defect.

Next, the distal end of the long lumen catheter 7 shown in FIG. 3 is arranged at the position of the atrial septum defect, and the puncture member operating catheter 6 with the puncture member 1 built into the distal end is inserted into the long lumen catheter. 7 to the tip. The pressing member 12 extends into the inside of the diaphragm 15 of the atrial septal defect (FIG. 5), and the pressing member 12 presses the inside of the diaphragm 15, and the puncture member 1 is pushed by the pushing member 11 to reach the diaphragm 15. (FIG. 6). Further, by pushing the pushing member 11, the puncture member 1 is inserted through the diaphragm 15,
The puncture member 1 enters the inside of the diaphragm 15 of the atrial septal defect (FIG. 7). After the four puncturing members 1 shown in FIG. 1 are arranged inside the septum 15 at the location of the atrial septal defect, the ends of the thread 3 attached to the four puncturing members 1 are attached to the annular member attached to the flat member 5. The flat member 5 is inserted into the small hole of the concave portion 14 and pushed up by the pushing member 11 to the diaphragm 15 of the atrial septal defect. Next, the extruding member 11 is removed from the puncture member operating catheter 6, the thread 3 is inserted into the small hole of the ridge 13 while the thread 3 is pulled, and each of the protrusions 13 is gripped by the gripping member. Is slid along the thread 3 and the ridge 13 and the annular recess 14 are fitted or screwed together, whereby the plate member 5 closes the atrial septal defect hole (FIG. 2). Finally, a cutter having a scissor-like tip is introduced into the lumen of the long lumen catheter 7, and the extra thread 3 is cut to complete the operation of closing the atrial septal defect.

[0009]

EXAMPLES Examples of the present invention will be described below with reference to examples. FIG.
FIG. 2 is a view for explaining an example of the prosthetic material of the present invention. FIG. 2 shows one of the puncturing members of FIG. 1 penetrating the septum edge of the atrial septal defect, and the prosthetic material closes the atrial septal defect hole. FIG. 3 is a cross-sectional view showing an example of a puncture member operating catheter in which a puncture member is attached to the distal end cavity, and FIG. 4 is a puncture member operation in which the puncture member is attached to the distal end cavity. FIG. 5 is a cross-sectional view showing another embodiment of the catheter for use, and FIGS. 5 to 7 are explanatory views illustrating an example of a process in which a prosthetic material closes a hole in the atrial septum using the catheter of the present invention. 8 is an explanatory view showing another embodiment of the pressing member, FIG. 9 is an explanatory view showing another embodiment using the catheter of FIG. 3, and FIG.
FIG. 10 is an explanatory view when the flat member obtained in the embodiment of FIG. 9 closes the atrial septal defect hole. In the figure, 1 is a puncture member, 2 is a frame, 3 is a thread, 4 is a penetrating portion, 5 is a flat member, 6
Is a catheter for operating a puncture member, 7 is a long lumen catheter, 8
Is a primary lumen, 9 is a first secondary lumen, 10 is a second secondary lumen, 11 is a pushing member, 12 is a holding member, 13 is a ridge, 14 is an annular recess, 15
Indicates a diaphragm with atrial septal defect.

FIG. 1 is a view for explaining an example of a prosthetic material according to the present invention, in which a thread-like material 3 extending from a puncture member 1 is a substantially circular plate-like member having a ring-like frame 2 around the periphery. FIG. 5 is a diagram in which the puncture member 1 and the plate-shaped member 5 are connected to each other by penetrating four through portions 4 provided in the piercing member 5. For example, one end of the thread 3 is inserted through a small hole formed substantially in the center of the puncture member 1 and fixed with a knot or a fastener, and the other end is inserted through the penetrating portion 4 of the flat member 5 and has a long cavity. The catheter 7 extends to the outlet of the insertion port. Then, after the puncture member 1 punctures and penetrates the diaphragm 15 at the atrial septum defect, the flat member 5 is moved in the direction of the puncture member 1 by the pushing member 11, and the flat member 5 closes the atrial septum defect hole. It is supposed to. Although not shown in FIG. 1, a ridge 13 as shown in FIG. 2 is used as a fixture for the flat member 5, the diaphragm 15 of the atrial septal defect, and the puncture member 1. By fitting or screwing into the annular recess 14 attached to the through portion 4, the movement of the thread 3 at the contact surface between the annular recess 14 and the ridge 13 is suppressed. As a result, the puncture member 1 placed on the inner wall of the diaphragm 15 at the location of the atrial septal defect
And the fibrous material 3 via the septum 15 to close the atrial septal defect hole. In FIG. 1, the plate-like member 5 is provided with a frame 2 around the periphery to facilitate closing of the atrial septal defect hole. However, the periphery of the knitted or woven fabric is bordered with a suture or the like for use. You can also. The size of the flat member 5 is at least 105 times the size of the atrial septal defect hole.
%, Preferably 110 to 150%.

FIG. 2 shows that one of the puncture members 1 of the prosthetic material shown in FIG. 1 punctures and penetrates an edge of a diaphragm 15 having an atrial septum defect, and is attached to the flat member 5 and the thread 3 via the diaphragm 15. FIG. 9 is a cross-sectional view showing an example when the operation is performed. As the puncture member 1, a hollow injection needle having a sharp tip can be used, but a cylindrical member capable of puncturing a diaphragm 15 of an atrial septal defect having a sharp tip such as a conical shape or a polygonal pyramid shape. Is preferred. The puncture member 1 has a small hole 16 formed in the vicinity of the center thereof, the thread 3 passes through the small hole 16, and one end thereof is fixed with a knot or the like. Further, when the puncture member 1 punctures the diaphragm 15 of the atrial septal defect, the thread-like material 3 enlarges the puncture site. Therefore, a longitudinal groove is formed from the small hole 16 to the end of the cylindrical member, and the thread-like material is formed in the groove. The object 3 may be buried to puncture the diaphragm 15 of the atrial septal defect. The thread-like material 3 is formed by the penetrating portion 4 of the flat member 5.
And a small hole of an annular concave portion 14 mounted on the opposite surface of the flat member 5 of the penetrating portion 4, and its end extends to the outlet of the insertion opening of the long cavity catheter 7. A ridge 13 having a small hole from the end of the thread 3 is pushed to the annular recess 14 through the main lumen 8 of the catheter 6 for puncturing member operation.
Supply using 13 gripping members (not shown), annular recess
The flat member 5 is attached to the septum 15 of the atrial septum defect by fitting or screwing with 14 to close the atrial septum defect hole.

Examples of the flat member 5 include polyester such as polyethylene terephthalate, polyolefin such as polyethylene and polypropylene, polyamide such as nylon 6 and nylon 66, and fluorine such as polyethylene fluoride and polyvinylidene fluoride. Knitted and woven fabrics, non-woven fabrics, films, porous sheets made of biocompatible materials such as resins, chlorine resins such as polyvinyl chloride and polyvinylidene chloride, polyurethane, cellulose-based semi-synthetic resins, natural fibers and the like And the like. Examples of the material of the frame 2 provided around the plate-like member 5 include metals, ceramics, and synthetic resins, and a superelastic alloy such as a Ni-Ti alloy or a Cu-Al-Ni alloy is particularly preferable. In FIG. 1, a circular member is used as the plate-shaped member 5. However, a polygon such as a triangle, a quadrangle, and a rhombus, an ellipse, and the like can also be used. Examples of the thread 3 include a suture or a monofilament made of a biocompatible material.

FIG. 3 is a partially cutaway sectional view of the puncture member operating catheter 6 having the puncture member 1 in the distal end cavity. The puncture member operating catheter 6 includes a puncture member 1 for puncturing the edge of the septum 15 at the point of atrial septal defect at the tip,
A main lumen 8 in which an extruding member 11 for pushing out the puncture member and the flat member 5 through which the thread 3 attached to the puncture member is inserted through a distal end opening 19, and an atrial septal defect hole And a pressing member 12 which sandwiches the edge of the diaphragm 15 of the atrial septal defect with the wall 20 which contacts the inner wall of the diaphragm 15 of the atrial septal defect and forms the distal end opening 19 of the main lumen 8 is inserted. The first
And a sub-lumen 9. The holding member 12 is formed of a flat plate 17 having an inner hole 18 having a size such that the puncture member 1 can pass through the distal end and an outer diameter capable of passing through the atrial septal defect hole.
Reference numeral 21 denotes a rod-shaped member, and the rear end of the handle portion 21 extends to the outlet of the insertion opening of the long lumen catheter 7, and the first sub-lumen 9
It can slide inside. When the puncture member operating catheter 6 is inserted into the long lumen catheter 7, the distal end flat plate 17 contacts the distal opening 19 of the puncture member operating catheter 6 to reach the atrial septal defect. be introduced. In addition,
Since the thread-like material 3 extending from the second and subsequent puncturing members 1 exists outside the inner hole 18 of the pressing member 12, the thread-like material 3 is moved to the inside of the inner hole 18 and the flat member 5 is moved into the atrium. When shifting to a septum defect, the flat plate constituting the holding member 12
A cutout (not shown) is formed at one location on the outer edge of 17, and the thread 3 is formed so as to enter the inner hole 18 of the holding member 12 through the cutout. In FIG. 3, the holding member 12 has an L-shape. In this embodiment, the position where the thread 3 penetrates through the diaphragm 15 at the atrial septum defect is determined by the position of the diaphragm 15.
There is a risk that the thread-like material 3 penetrating the diaphragm 15 may come off from the diaphragm 15 because the distance from the edge of the thread is short. In this case, as shown in FIG. 8, when the tip of the grip portion of the holding member 25 is used in a curved state, the position of the thread 3 penetrating the diaphragm 15 is separated from the edge of the diaphragm 15, The thread 3 does not come off the diaphragm 15.

When the distal end of the puncture member operating catheter 6 reaches the atrial septal defect, the distal end flat plate 17 of the pressing member 12 is rotated to separate from the distal opening 19 of the puncture member operating catheter 6, The handle portion 21 is extended to allow the distal end flat plate 17 to pass through the atrial septal defect hole and contact the inner end wall of the diaphragm 15 at the atrial septal defect position, thereby forming the distal end opening of the puncture member operating catheter 6. The diaphragm 15 at the site of atrial septal defect is sandwiched between the wall portion 20 and the wall portion 20. In such a state, the pushing member 11 extending to the outlet of the insertion opening of the long cavity catheter 7 is pushed forward from the outside, so that the puncture inserted into the distal end lumen of the puncturing member operating catheter 6 is performed. The member 1 punctures the septum 15 at the atrial septum defect, and further pushes the pushing member 11, whereby the puncture member 1 penetrates the septum 15 and enters the inside of the atrial septum defect. By returning the pushing member 11 from the inside of the main lumen 8 of the puncture member operating catheter 6 to the outside of the insertion opening of the long-lumen catheter 7, the thread 3 extending from the puncture member 1 loses the atrial septum. It extends to the outside of the insertion port of the long lumen catheter 7 through the septum 15 at the location.

When the thread 3 is pulled, the puncture member 1 on the inner side 12 of the septum 15 at the location of the atrial septal defect has the proximal end of the thread 3 near the center, so that the puncture member 1 moves in the longitudinal direction as shown in FIG. The puncture member 1 is placed in contact with the septum 15 and does not fall out of the septum 15 at the site of atrial septal defect from the inside to the outside. Next, the other end of the thread 3 protruding outside the insertion opening of the long cavity catheter 7 is inserted through the small hole with the annular concave portion 14 attached to the penetrating portion 4 of the flat member 5 facing rearward. Then, the flat member 5 is inserted from the main lumen 8 of the puncture member operating catheter 6 to the diaphragm 15 at the location of the atrial septal defect by the pushing member 11. Thereafter, the pushing member 11 is moved to the puncture member operating catheter 6.
The thread 3 is inserted outwardly from the main lumen 8 and the thread 13 is inserted into the small hole of the ridge 13 and the projection 13 is slid along the thread 3 by a gripping member that grips the thread 13. The thread 3 is inserted into the annular concave portion 14 mounted on the flat plate member 5, and the thread 3 is brought into contact with the annular concave portion 14 by fitting or screwing the projecting portion 13 and the annular concave portion 14. The plate-like member 5 is closed by the surface and is fixed to the end wall of the diaphragm 15 at the location of the atrial septal defect.

Heretofore, one through portion 4 of the flat member has been used.
1 has been described, but around the substantially circular plate-shaped member 5, as shown in FIG.
There are four through-holes 4 and four thread-like objects 3 passing therethrough. The four puncturing members 1 are used to separate the diaphragm 15 at the location of the atrial septal defect.
Is placed inside the septum 15 of the atrial septal defect and then penetrates the end of the thread 3 attached to the puncture member 1 and extending to the outlet of the insertion opening of the long lumen catheter 7. Each of the flat members 5 is inserted into the annular concave portion 14 fitted to the flat member 5 from the portion 4, and the flat member 5 is moved to the atrial septum defect site by the pushing member 11. At this time, since the thread 3 extending from the second and subsequent puncturing members 1 is present outside the inner hole 18 of the holding member 12, the holding member is moved to move the thread 3 inside the inner hole 18. A notch (not shown) is formed at one position on the outer edge of the flat plate 17 constituting the 12, and the thread 3 enters the inner hole 18 of the holding member 12 through the notch. Thereafter, the push-out member 11 is removed from the catheter for operating the puncture member, and the thread 3 is inserted into the small hole of the ridge 13 while the thread 3 is being pulled. The thread 3 is closed by sliding along the object 3 and fitting or screwing the ridge portion 13 and the annular concave portion 14, and the flat member 5 is fixed to the end wall of the diaphragm 15 at the defect site of the atrial septum. Then, the flat member 5 closes the atrial septal defect hole. Finally, a scissor-shaped cutter is introduced into the lumen of the long lumen catheter 7 so that the extra thread 3
The operation for occluding the atrial septal defect is completed by cutting.

FIG. 9 shows a catheter 6 for puncturing member operation shown in FIG.
Is used, the puncture member 1 is not disposed inside the diaphragm 15 of the atrial septal defect, and the thread 3 is inserted through the flat member 5 and the diaphragm 15 at the location of the atrial septal defect to close the atrial septal defect hole. FIG. 9 is an explanatory diagram of an embodiment in the case of performing the operation. In a state where the puncture member 1 is inside the atrial septum defect as shown in FIG. 7 and outside the holding member 12, the holding member 12 is separated from the diaphragm 15 at the atrial septum defect, and the thread 3 is removed from the atrial septum defect. When the holding member 12 is pulled forward from the atrial septum defect hole after being extended inside, the puncture member 1 is also moved to the outside of the diaphragm 15 at the location of the atrial septum defect together with the flat plate 17 of the holding member 12. By piercing the thread 3 in the inner hole 18 of the flat plate 17 from the cutout of the flat plate 17 of the holding member 12, the puncture member 1 is moved to the septum at the defect site of the atrial septum.
The inside of the main lumen 8 enters from the 15 edge. Thereafter, a bar-like member having a hook-like tip is inserted into the main lumen 8, the puncture member 1 is hooked and pulled out of the insertion opening of the puncture member operation catheter 6, and the thread 3 is cut to cut the puncture member. Remove one. The ends of the thread 3 out of the two threads drawn out of the insertion opening of the puncture member operating catheter 6 are respectively inserted into the annular recesses 14 fitted to the flat member 5 from the through portion 4. The insertion position of the inserted and returned thread 26 into the flat member 5 is
The thread 3 penetrates into the position of the flat plate member 5 away from the position of the annular concave portion 14 which is substantially equivalent to the distance from the penetration point of the diaphragm 15 at the defect point of the atrial septum to its edge.

Then, after the flat member 5 is moved to the atrial septal defect by the pushing member 11, the pushing member 11 is removed from the puncture member operating catheter. In a state where the thread 3 and the returning thread 26 are pulled, the end thereof is inserted into the small hole of the ridge 13 having two small holes, and the ridge 13 is inserted into the flat member 5 by a gripping member. Sliding along the thread 3 and the return thread 26 to the position of the fitted annular recess 14 respectively,
The ridge 13 and the annular recess 14 are fitted or screwed together. The thread 3 is closed at the contact surface between the ridge 13 and the annular recess 14, and the flat member 5 is fixed to the end wall of the septum 15 at the location of the atrial septum defect. Close. Finally, a cutter with scissor-shaped tips in the lumen of the long lumen catheter 7
To complete the occlusion of the atrial septal defect by cutting the extra thread. FIG. 10 is an explanatory view when the flat member 5 made by the embodiment of FIG. 9 closes the atrial septal defect hole. Diaphragm 15 at atrial septal defect
And the plate-shaped member 5 are annular concave portions fitted to the plate-shaped member 5.
It is closed by the thread 3 passing through the ridge 13 and 14. Further, the return thread 26 pierced through the diaphragm 15 at the atrial septal defect is inserted around the edge of the diaphragm 15, penetrates the through-hole 27 of the flat member 5, and is inserted into the small hole of the ridge 13. And ridges
The movement of the thread 26 is closed at the contact surface between the ring 13 and the annular concave portion 14.

FIG. 4 is a sectional view of the vicinity of the distal end of another embodiment of the puncture member operating catheter 6 having the puncture member 1 in the distal end cavity. The puncture member operating catheter 6 has at least two puncture members 1 for puncturing the edge of the diaphragm 15 having the atrial septal defect at the tip, and the thread member 3 attached to the puncture member and the puncture member. Through the main lumen 8 in which the flat plate member 5 is inserted and the hole of the atrial septal defect, and contacts the inner wall of the diaphragm 15 of the atrial septal defect to form a distal opening 19 of the main lumen 8. The first sub-lumen 9 in which the holding member 12 for sandwiching the edge of the diaphragm 15 of the atrial septal defect with the wall 20 to be inserted and the puncture member 1 inserted in the main lumen 8 are operated by the puncture member. And a second sub-lumen 10 into which an extruding member 22 for pushing forward from the tip opening 19 of the catheter 6 is inserted. The extruding member 22 is formed of a rod-shaped member whose tip can be bent, and slides inside the second sub-lumen 10 formed in the wall of the main lumen 8. Opening of the tip of the second sublumen 10
Reference numeral 24 is formed at a position which enters at least the length of the puncture member 1 from the distal end opening 19 of the puncture member operation catheter 6.

Examples of the inflexible rod-shaped member constituting the tip of the pushing member 22 include flexible materials such as metal such as soft iron and copper, ceramics, and plastics. The end is pushed, and the puncture member 1 is pushed up until it protrudes from the distal opening 19 of the puncture member operating catheter 6 and penetrates the septum 15 of the atrial septal defect. Most of the extruding member 22 except for the distal end portion is preferably made of a rigid material such as metal, ceramic, or plastic in order to push up the puncture member 1. The first puncture member 1 is a diaphragm at the site of atrial septal defect
After the insertion of the member 15, the pushing member 22 is lowered rearward, and its tip is straightened and enters the inside of the second sub-lumen 10. The second puncturing member 23 inserted into the main lumen 8 of the puncturing member operating catheter 6 is, for example, a rod-shaped member or the like from the rear of the puncturing member operating catheter 6, and the tip thereof is a puncturing member operating catheter. −
The teller 6 is pushed forward until it reaches the tip opening 19. Next, by pushing up the pushing member 22 inside the second sub-lumen 10, the tip of the pushing member 22 enters the main lumen 8 through the opening 24 of the second sub-lumen 10, and the tip is bent and The rear end of the puncture member 23 is pushed forward until the second puncture member 23 penetrates through the septum 15 of the atrial septal defect. Although only two puncturing members are shown in the main lumen 8 in FIG. 4, four puncturing members and one flat member 5 are inserted in advance, and the puncturing members are sequentially inserted as described above. The operation is performed until the diaphragm 15 of the atrial septal defect is inserted by an operation.

After each of the four puncturing members has been inserted through the end wall of the diaphragm 15 at the location of the atrial septal defect and placed inside the diaphragm 15 of the atrial septal defect, the puncturing member located behind the last puncturing member The flat member 5 into which the thread 3 attached to the member is inserted is pushed up to move from the opening 19 of the puncture member operating catheter 6 to the atrial septal defect. Thereafter, the thread 3 is inserted through the small hole of the ridge 13 while the thread 3 is pulled from the outlet of the insertion port of the puncture member operating catheter 6, and the thread 13 is respectively gripped by the gripping member. The thread 3 is closed by fitting or screwing the ridge 13 and the annular concave portion 14 fitted to the flat member 5 so that the flat member 5 is closed at the location of the atrial septum defect. Fixed to the end wall of the diaphragm 15,
The flat member 5 closes the atrial septal defect hole. Finally, a cutter having a scissor-like tip is introduced into the lumen of the long lumen catheter 7, and the extra thread 3 is cut to complete the operation of closing the atrial septal defect.

[0022]

According to the present invention, the prosthetic material is placed at the center of the atrial septum defect hole in order to close the atrial septum defect with the puncture member 1 to close the flat member 5 made of a human body-compatible material. It can be placed and eliminates the risk of the closure material being displaced from the center of the atrial septal defect hole when using a closure material in which two umbrellas are overlapped, such as a conventional prosthetic material. Also, unlike the conventional prosthetic material, there is no need to use a closure material twice as large as the atrial septal defect hole, and the strut is not cut due to the stress reduction or fatigue of stainless steel, and simple operation is possible. Thus, the prosthesis can be firmly and permanently fixed to the atrial septum at the defect site of the patient by the percutaneous transluminal catheter method.

[Brief description of the drawings]

FIG. 1 is a diagram illustrating an example of a prosthetic material according to the present invention.

FIG. 2 is a cross-sectional view when one of the puncturing members of FIG. 1 penetrates the septum edge of the atrial septal defect and the prosthesis closes the atrial septal defect hole;

FIG. 3 is a cross-sectional view showing an example of a catheter for operating a puncture member in which a puncture member is attached to a distal end lumen.

FIG. 4 is a cross-sectional view showing another embodiment of a catheter for operating a puncture member in which a puncture member is mounted in a distal end cavity.

FIG. 5 is an explanatory view illustrating a process in which a prosthetic material closes an atrial septal defect hole using the catheter of the present invention.

FIG. 6 is an explanatory view illustrating a process in which a prosthetic material closes an atrial septal defect hole using the catheter of the present invention.

FIG. 7 is an explanatory view illustrating a process in which a prosthetic material closes an atrial septal defect hole using the catheter of the present invention.

FIG. 8 is an explanatory view showing another embodiment of the holding member.

FIG. 9 is an explanatory view showing another embodiment using the catheter of FIG. 3;

FIG. 10 is an explanatory view when the flat plate member obtained in the embodiment of FIG. 9 closes the atrial septal defect hole.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1, 23 Puncture member 2 Frame 3, 26 Thread 4, 27 Penetration part 5 Flat member 6 Puncture member operation catheter 7 Long cavity catheter 8 Main lumen 9 First sublumen 10 Second Sublumen 11,22 Extrusion member 12,25 Pressing member 13 Protrusion 14 Annular recess 15 Diaphragm at atrial septal defect

Claims (5)

(57) [Claims] At least two puncturing members capable of puncturing and inserting a septum at an atrial septal defect site, a flat plate member for closing the atrial septal defect site, and the flat plate member attached to the puncture member. A prosthetic material for atrial septal defect, comprising a thread-like material passing through the member. 2. The prosthetic material for atrial septal defect according to claim 1, wherein the flat member is a knitted or woven fabric made of a thread-like material of a biocompatible material. 3. The prosthetic material for atrial septal defect according to claim 1, wherein the flat member is provided with a frame around the flat member. 4. A puncture member for puncturing the edge of the diaphragm at the point of atrial septal defect at the tip, and a flat member through which the puncture member and a thread attached to the puncture member are inserted through the tip opening. A main lumen in which an extruding member for extruding is inserted, and a wall that passes through the atrial septal defect hole and contacts the inner wall of the septum of the atrial septal defect to form the distal opening of the main lumen, A catheter for closing an atrial septal defect hole comprising a first sub-lumen in which a holding member for sandwiching an edge of a septum defect is inserted. 5. An atrial septum defect hole according to claim 4, wherein an extruding member formed of a rod-shaped member having a bendable tip is inserted into a second auxiliary lumen formed in a wall of the main lumen. Catering to do.