RU2121821C1 - Intracardiac device for treating heart disease and method for occluding defect in heart disease cases - Google Patents

Abstract

FIELD: medical engineering. SUBSTANCE: device has prosthesis having remote blocking unit attached to cable and neighboring blocking unit coupled with the cable. The blocking units are introduced into the heart using known method and tuned corresponding to heart structure thickness at the defect place. One version of the device is designed to perform tuning by shifting the remote blocking unit over a number of nodes on the cable. Another version has neighboring blocking unit connected to remote blocking unit by means of flexible cable so that elastic tension of the cables makes the blocking units set in given position. Radiopaque node is set on cable to enable easy positioning of the blocking units. EFFECT: wide range of applications. 5 cl, 7 dwg

Description

 The invention relates to intravascular prostheses administered transarterially or transvenously and intended for the occlusion of heart defects.

 A device with two discs / US patent N 3874388 / for the occlusion of intracardiac defects and especially atrial septal defects / ASD-atrial septal defect /. The device was bulky, requiring the introduction of 23G. The device uses two discs on the same catheter. The disks are made of polyurethane foam and metal frame. They are attached to the main catheter through a complex release / release / mechanism. The removed disc is removed on the arterial side of the duct, and the proximal disc is removed on the side of the pulmonary artery, if transvenous occlusion of the overgrown ductus arteriosus / PDA / is used. The device requires a larger insertion / 11F / for undeveloped arterial ducts / PDA / greater than 4 mm, and an inserted 8G casing for small undeveloped arterial ducts. Therefore, the method has not found application for young children with large compounds. In addition, its device is not applicable for long and tubular overgrown arterial ducts / PDA / or even for very short ones. Due to the large injected sheath / ochezh / often there is a need for delatation of the small duct using plastic cylinders before performing occlusion. The frequency of residual blood flow is significant, especially with large PDAs. The disadvantage of this method is that the channel remains, despite its occlusion, since the device blocks only a narrow part of the duct.

 Known "Device with nodules for occlusion of intracardiac defects" / US patent N 4917089 /. This device is formed by two independent input disks that ultimately cover the defect. It requires a small casing / 7-8F / for administration and can be used for young children. However, the distance between the two discs is predetermined, since the loop with nodules has a length of 2-4 mm for use in case of atrial septal defect / ASD /. Therefore, what can be applicable for the occlusion of defects of the atrial septum / ASD /, cannot be used for the occlusion of long "tubular" overgrown arterial ducts / PDA /. The thickness of the interventricular septum differs from the thickness of the interatrial septum, and therefore an overlapping device for occlusion of an atrial septal defect cannot be used to occlude an interventricular septal defect.

 The intracardiac devices of the present invention are means for transarterial or transvenous occlusion of heart defects without surgery, containing two such adjustable devices: an adjustable device with nodules and a self-regulating double-disk device.

 A device with knots. Occlusion can be transvenous or transarterial and can be performed by independently introducing two elements with nodules - a blocker / obturator / and a counterblocker. All elements have been described in US Pat. No. 4,917,089, which belongs to the inventor of this application.

 Nevertheless, there are a number of differences, in particular for a loop attached to the center of the blocker. In a preferred embodiment of the blocker loop, the nylon 3.0 loop has a length of 8 mm. It consists of an annular loop with a diameter of 1 mm, a radiopaque nodule / thickening /, an average loop of 2 mm and a near loop of 2 mm. Separate loops and a radio contrast node are separated by triple nodules. Due to the length of the loop and the presence of several nodules / thickenings / the device can be adjusted for occlusion of the overgrown arterial ducts / PDA / of various lengths and defects of the septa with different thicknesses.

 Since the introduction of blockers of 15 and 20 mm in size can be carried out through small casings / 7F or 2.3 mm /, the device can even be used for small children.

 Double disc device. It consists of the following elements: a proximal disc, a distant disc, connecting suture material between them / elastic suture material and safety nylon thread / and a wire for separation. In a preferred embodiment, the remote drive of the device is made of a single wire frame, sewn to the disk of polyurethane or woven material.

 The wire has a size / diameter / 0.4572 mm / 0.018`` / and contains a fluorocarbon polymer / Teflon - TEFLON / hollow outer part with a central part of 0.2286 mm / 0.009 '' / stainless steel. It is rounded in the middle with a diameter equal to the length of the wire frame, and it is tapered at an angle at the ends of the wire for easier insertion. Another feature of the present invention is the proximal disk. It is made in exactly the same way as the remote disk. An important feature of this device is the connecting suture material between the two discs.

 The connecting suture has two elements: an elastic suture and a safety nylon thread. They are connected in the center of the lower surface of the remote disk and in the center of the upper surface of the proximal disk. The elastic suture is latex suture and has a length of 2 mm in an unstretched state and a length of 10 mm in a taut state, the other suture is a single nylon 3.0 thread and has a length of 10 mm.

 On the lower surface of the proximal disc, a 1 mm nylon loop made of nylon 3.0 is stitched.

 Another feature of the invented device is a disconnecting wire. It is a hollow wire coated with fluorocarbon polymer / Teflon - TEFLON / size 0.889 mm / 0.035 / with a double nylon thread 0.2032 mm / 0.008 '' thick / attached to the nylon loop of the near disk.

 The device is inserted into a long casing / shell / size 5-6F. The casing is installed across the defect; the remote disk is detached and retracted to the edge of the long casing so that the disk becomes perpendicular to the casing; after that, the casing and the remote disk are pulled out until the disk covers the defect. The casing is carefully pulled back with the device taut until the near disc is completely detached near the defect cavity. Then the tension is relaxed and the near disk automatically blocks the defect. Manipulations are possible using fluoroscopy and echocardiography. The device is disconnected using the same mechanism as in the device with knots.

 In accordance with the principles of the present invention, adjustable devices have significant advantages. They are made miniature in size and can be adjusted for different lengths of the duct or thickness of the interventricular septum.

 The purpose of this invention is to develop adjustable devices for occlusion that are small enough to be administered to a child of any age.

 Another objective of the present invention is to provide the possibility of adjusting the length between the disks in accordance with the length of the duct or the thickness of the septum.

 The next chain is to achieve the possibility of universal application for defects of various sizes and shapes.

 Additional goals are to achieve the above advantages in devices that are strong, compact, durable, lightweight, simple, reliable, efficient, versatile, environmentally compatible, energy-saving and safe, and yet inexpensive to manufacture.

 Other goals are to achieve the above using a method that is fast in implementation, versatility, environmental compatibility, energy-efficient, efficient and does not require highly qualified personnel during installation and maintenance.

 FIG. 1 shows a device with nodules and a blocker connected by a loop with nodules with a loading wire.

 FIG. 2 shows a blocker.

 FIG. 3 shows the connection of the loop with the nodules with the wire frame of the blocker.

 FIG. 4 shows a blocker.

 FIG. 5 shows a self-adjusting dual disk in an unfolded state.

 FIG. 6 - also folded and inserted into the casing.

 FIG. 7 is a cross-sectional view of a dual-disk, self-adjusting device that blocks an overgrown ductus arteriosus.

The intracardiac device for the correction of heart defects contains a blocker 1 / or a remote blocker / connected by a loop 2 to nodules / or a cord / and to a counterblock 3 / or a near blocker /. Loop 2 with knots is made of nylon thread 3.0 and consists of:
a / end small loop 4 with a diameter of 1-2 mm; the end small loop 4 receives a nylon thread from the feed wire 5;
b / radiopaque site 6 with a length of 1 mm; it is formed by a hollow coated with fluorocarbon polymer / Teflon-TEFLON /, a wire with a diameter of 0.889 mm / 0.035 / and is separated by three knots from the end loop 4 and the middle loop 7;
c / middle loop 7, having a diameter of 2-3 mm and separated from the radiopaque site 6 and from the first loop 8 by three knots;
d / three nodules between the middle loop 6 and the first loop 8, forming the middle node 9;
e / of the first loop 8 having a diameter of 3 mm, the boundaries of which are the middle node 9 and the end three nodes 10.

 The loop 2 is connected by nodules with the blocker 1, and the two ends of the nylon thread are introduced upward through the porous material in the corners / A, B /. They are pulled together by two knots 6 on the upper surface of the blocker 1. After that, the ends of the nylon thread are brought down through the porous material in the corners / C, D /. They are tightened at the bottom surface of the blocker 1 by three nodes 6. The method of adjustable overlapping involves the introduction of one of the nodes of the loop 2 with the nodes through the polymer center of the counterblock 3 and / fastening / joining due to valve-like action. If the duct length or the thickness of the septum exceeds 5-6 mm, the counterblock 3 stops immediately after the radiopaque node 6. If the duct length or the thickness of the septum is less than 3 mm, the counterblock 3 crosses / passes through the / middle node 9. The device can also be adapted to intermediate situations .

 In the double-disc self-regulating device there is a remote disk 11 or a remote blocker, connecting suture material 12 / or a cord / between two disks; proximal disk 13 or / proximal blocker / disconnecting wire 5. Remote disk 11 is made of polyurethane foam or woven material and has a rounded shape. Coated single or double wire 1-16 has free-hanging ends.

 In the center of the wire frame of the lower surface of the removed disc 11, elements of connecting suture materials are inserted. There are two connecting suture materials: one is elastic suture 15 with an unstretched length of 1-2 mm and an extended length of 10 mm and the second is a nylon safety thread 16. Safety thread 16 has a length of 10 mm. Connecting suture materials connect the lower surface of the removed disk 11 and the upper surface of the proximal disk 13 in the center of their respective wire frame / wire frame /.

 The proximal disk 13 is made of polyurethane foam or woven material and has the same dimensions and shape as the remote disk 11. A nylon loop 17 with a diameter of 1 mm is sewn on the lower surface of the proximal disk 13.

 During operation, the device is inserted into the long casing 18. The remote disk 11 is inserted first, followed by the proximal disk 13. The catheter-pusher 19 is inserted along the loading wire 5 into the long casing 18.

 The overgrown ductus arteriosus is blocked by a transarterial self-regulating double-disc device. The removed disc 11 is disconnected in the pulmonary artery and pulled to the pulmonary end of the duct. Then the long casing 18 is drawn into the aorta, where the proximal disk 13 is disconnected, and this disk is automatically attracted by the elastic thread to the arterial end of the duct. Due to the presence of an elastic connecting thread 16, the device can self-regulate depending on the length of the duct. Disconnecting is the same as in a device with knots.

 The device can be made of various modifications, design, material, location and operation within the scope of the present invention.

Claims (4)

 1. An intracardiac device for the correction of heart defects, introduced through the skin, containing a blocker consisting of a folding disk of a foam polymer and a wire frame with a coating in the form of the letter X, attached to the disk of the foam polymer with an adjustable loop attached to the center of the wire frame, characterized in that an adjustable loop is formed by a first loop attached to the specified wire frame, a middle loop attached to the first loop, an end small loop attached to the middle loop, and X-ray it is an ontrust assembly attached between two of the loops of the indicated adjustable loop and further comprises a counter blocker with a loading wire made hollow and coated with fluorocarbon polymer, and a long double thread is tied through an end small loop and through a hollow wire, while the counter blocker can be pushed along loading wire to the blocker and stops at a distance adjustable in accordance with the length or thickness of the overlapping structure.  2. An intracardiac device for the correction of heart defects, introduced through the casing, characterized in that it contains a remote folding disc made of polyurethane or woven material on a wire frame, the near folding disk made of polyurethane or woven material on a wire frame, and the remote folding disk attached to the near folding disc with an elastic thread and a nylon safety thread having a length of 1.2 m in an unstretched state and 10 mm under tension, and a nylon thread has a length of 10 mm, disconnects the wire attached to the loop of suture 1 mm in diameter, which is attached to near the lower disc surface.  3. A method of occlusion of a heart defect through the structure of the heart, characterized in that the remote blocker is attached to the cord having a number of nodes, the near blocker is connected to the cord, the remote blocker is placed on the far side of the heart structure, the near blocker is placed on the near side of the heart structure and regulation the length of the cord between the discs in accordance with the approximate thickness of the heart structure by moving the near blocker over a number of nodes on the cord until the blockers leaning in the overlapping position, thereby holding the remote blocker in the overlapping position above the defect on the remote side and holding the near blocker in the overlapping position above the defect on the near side.  4. A method of occlusion of a heart defect through the structure of the heart, characterized in that they attach the remote blocker to the elastic cord, attach the near blocker to the elastic cord, place the remote blocker on the far side of the heart structure, place the near blocker on the near side of the heart structure and adjust the length of the cord between the discs in accordance with the approximate thickness of the heart structure by pulling the elastic cord to position the near blocker, thereby the remote blocker is held in an overlapping position above the defect on the remote side and the proximal blocker is held in an overlapping position above the defect on the proximal side.

Images