CN100496431C - Stopper for congenital heart structural defect, its manufacturing method - Google Patents

Abstract

The invention relates to an occluder for congenital heart structural defect. At present, patients with congenital heart disease ventricular septal defect and atrial septal defect are preferably treated with minimally invasive interventional methods. Therefore, the invention provides a device for An occluder for congenital structural defects of the heart, the occluder is composed of a metal braided stent and a built-in fibrous material for blocking blood flow, wherein the metal braided stent is all braided by wire , which has a preset expanded shape; the shape of the occluder can occlude the defect of the abnormal structure of the heart. The present invention adopts the metal wire weaving technology to make the discs on the left atrium and ventricle side to make them smooth, avoiding the unevenness of the discs on the left atrium and ventricle side caused by the use of fixing screws on the left atrium and ventricle side by the current occluder . In the present invention, the left and right atria and the side of the ventricle are all braided by nickel-titanium alloy wires, the surface is smooth and has some invaginations, which is beneficial to the formation of epithelialization after the occluder is implanted.

Description

An occluder for congenital structural defects of the heart and its fabrication method

technical field

The invention relates to an intravascular medical instrument for treating certain diseases, in particular to an occluder for congenital heart structural defect and its fabrication method.

Background technique

Congenital heart disease Ventricular septal defect, or atrial septal defect, is a common congenital heart disease characterized by the failure of the septum between the left and right atria and the left and right ventricles to close normally after birth. Since the pressure of the left atrium and left ventricle is higher than that of the right atrium and right ventricle, under pressure, the blood on the left side is shunted to the right atrium or right ventricle through atrial septal defect or ventricular septal defect, resulting in increased burden on the right heart system, Cause right ventricular hypertrophy, increased blood volume in the pulmonary circulation, eventually can cause pulmonary hypertension, arrhythmia and heart failure. In the past, the traditional treatment method for ventricular septal defect and atrial septal defect was surgery. Surgery requires general anesthesia, thoracotomy, extracorporeal circulation, and blood transfusion during the operation, which is traumatic to the patient, has a high incidence of complications, and leaves surgical incision scars on the body surface. In order to allow patients with congenital heart disease ventricular septal defect and atrial septal defect to be treated with minimally invasive interventional methods, since 1976, a variety of occluding devices have been invented at home and abroad, and the application of occluders sent through cardiac catheters to close the ventricular septum has been explored. Defect, atrial septal defect, to achieve the same curative effect as surgical thoracotomy. At the same time, blood transfusion and complications caused by blood transfusion and surgical operation can be avoided.

The main instrument for closing ventricular septal defect and atrial septal defect through catheter is a device for closing ventricular septal defect and atrial septal defect, which is called an occluder. The occluder is in the shape of double discs, and the discs of the occluder are braided by superelastic metal wires. They are sent to the defect of the heart through the cardiac catheter, and automatically restore the original shape of the design after being pushed out of the catheter, and are clamped on the defected atrial septum. Or both sides of ventricular septal defect to close the defect to achieve the purpose of curing ventricular septal defect and atrial septal defect.

Several medical device companies at home and abroad are developing occluders, and the products currently on the market include CardioSEAL and Amplatzer occluders.

The type of VSD and ASD is an important determinant of transcatheter therapy. Lesions of ventricular septal defect suitable for transcatheter closure are characterized by the edge of ventricular septal defect being at least 2mm away from the aortic valve and tricuspid valve; Valve and tricuspid valve more than 5mm. Ventricular septal defect and atrial septal defect vary in size and irregular shape, requiring occluders with different diameters to suit different sizes of ventricular septal defect and atrial septal defect. The heart is beating non-stop, and the occluder should be able to reliably fix the ventricular septal defect and atrial septal defect after it is in place. Whether the occluder can be reliably fixed depends on the size of the selected occluder and the hardness of the occluder bracket. The occluder has high hardness and strong elasticity, which is conducive to fixation, but the high hardness is not conducive to the delivery of the occluder to the ventricular septal defect and atrial septal defect through the catheter, and it is also not conducive to withdrawing from the body if the selected size and model are not suitable. Therefore, the hardness of the metal stent of the occluder is required to be suitable. The hardness of the occluder mainly depends on the thickness of the nickel-titanium alloy wire and the superelasticity and shape memory properties after heat treatment. Since most of the patients with ventricular septal defect and atrial septal defect are children and the blood vessels are relatively thin, the delivery sheath inserted into the blood vessel should not be larger than the diameter of the femoral vein. Therefore, the thickness of the nickel-titanium wire, the superelastic shape memory performance and the selection of the catheter diameter are one of the principles for the design and manufacture of the occluder. In addition, the surface of the occluder should be flat and smooth so that it is not easy to form thrombus on its surface. Therefore, the integrated treatment of the surface should be fully considered in the design of the occluder surface.

Contents of the invention

The purpose of the present invention is to provide a structurally reasonable occluder for congenital heart structural defects.

The present invention provides an occluder for congenital heart structural defect, which is composed of a metal braided stent and a built-in fibrous material for blocking blood flow, wherein, the metal braided stent is all braided by metal wires. It has a preset expanded shape; the shape of the occluder can occlude the defect of the abnormal structure of the heart, and the preset expanded shape can be deformed into a smaller cross-sectional shape for delivery through the patient's body For blood vessels and the heart, the metal braid has memory properties such that when unrestrained, the occluder returns to the preset expanded shape.

The invention provides an occluder for congenital heart structural defect, the occluder is composed of superelastic nickel-titanium alloy wire stent with shape memory function and polyester fiber membrane constrained in the stent Combined, it has the characteristics of being pulled into a line shape under force and recovering the preset expanded shape after removing the external force.

The present invention is mainly used for congenital heart disease ventricular septal defect and atrial septal defect, which is a common congenital heart disease. normally closed.

An occluder bracket for congenital heart structural defects provided by the present invention mainly includes a mesh-shaped cylindrical bracket, and a circular plane located at both ends of the bracket, and a fixed convergence point is provided in the center of the circular plane , a connecting ring is connected to one of the fixed gathering points.

The appearance of an occluder bracket for congenital heart structural defects mainly includes left and right double-sided disks, and a waist connecting the two disks. The waist is cylindrical, and the disk is larger than the The waist diameter is large.

The double-sided disk of the present invention is formed by braiding technology to form a flat plane, and the center point of the left plane is surrounded by the turns of the nickel-titanium alloy wires forming the bracket, and the nickel-titanium wires of the bracket itself are circularly penetrated. Each turnback makes it connected into a complete whole, and the center point of the left disk is gathered together by a nickel-titanium alloy wire to form a small bundle of gathering points, which repeatedly circles through the turnback to form a Strong anchor loops. There is no riveting on the surface of the bracket, and the structure is firm and the shape is reasonable. The central point of the right disk is used to gather the rings together through nickel-titanium alloy wires to form a small bundle of gathering points, which are repeatedly looped through the folded rings to form a firm fixation loop. The nickel-titanium wire composed of the present invention passes through the fixation loop many times to make a connecting ring connected with the fixation loop.

The occluder bracket provided by the present invention is made of the same metal material, has light weight, reasonable spacing, flat discs on both sides, proper elasticity, complete shape recovery, strong supporting force, convenient placement, easy positioning, and reliable curative effect.

Moreover, the present invention provides a basic manufacturing method of the occluder.

1. Fabrication of the occluder bracket

1. Production of mesh mold

The braided mold is the basis of the braided occluder bracket, which is generally made of strong and easy-to-manufacture metal materials, such as stainless steel, chrome stainless steel, metal alloys and other materials.

(1) According to the requirements of the preset expanded shape, make a weaving mold, and the weaving mold can generally be processed into a metal cylinder shape first;

(2) process several equally divided grooves with certain degrees on the surface of the metal cylinder;

(3) Drilling holes inside and outside the groove between the two ends of the metal cylinder to fix the folded fixing part of the braided net.

2. Preparation of occluder bracket

(1) Take the wire head of a metal wire, start the metal wire around the upper end turning part 21, and cling to the mould, rotate 360 degrees clockwise with a slope of 30-60 degrees, evenly up and down Wrap around to the lower turn-back portion 21' corresponding to the upper end 21;

(2) After bypassing the lower end turning part 21 ', then go around the upper end turning part 22 from the lower end close to the mould, in a counterclockwise direction;

(3) Go around the above-mentioned upper end turning part 22 similarly, and then go around to the lower end turning part 22' by the same method as above, and repeat like this until the entire above-mentioned mesh passing mold is wound around. After removing the turning part, a Mesh-tubular cylindrical metal stent.

The above-mentioned mesh-shaped cylindrical stent can be woven by a nickel-titanium metal wire back and forth at a certain angle without interruption. One end of the tubular cylindrical metal stent will eventually retain two longer wire ends.

3. Fabrication of fixed structures at both ends of the occluder bracket

(1) Utilize the two sections of wire left on the net-shaped upper port of the above-mentioned net tube-shaped cylindrical metal bracket to gather the annular folded ring of the upper port together, repeatedly circle through the folded ring, and tighten the two segments of wire, which can be placed on the net The upper mouth end of the shape forms a fixed cluster point circle.

(2) Using the same method as the upper weaving, a small circle of fixed cluster points can also be harvested at the lower end of the mesh.

(3) Repeatedly looping through the folded ring can form a firm fixed loop point at the upper and lower ends of the net tubular cylinder; after the final small circle is harvested, use one of the threads to pass through the small circle and go back and forth many times , forming a ring, using another wire to wind a rope-like ring on the ring until it intersects with another wire, and after several times of weaving and finishing, a connecting ring is formed.

Then heat it for heat treatment to preliminarily determine the network shape, so as to facilitate the processing of the subsequent process.

The wire mesh in the occluder bracket provided by the present invention can be woven by a conventional method, wherein the longitudinal wires and the transverse wires pass through each other to form small diamond-shaped boxes. As shown in accompanying drawing 30, wherein the longitudinal wire and the horizontal wire pass through each other, and are pressed under each other every other time, and the longitudinal wire and the horizontal wire can be arranged at an angle of 30°. Also as shown in accompanying drawing 31, the longitudinal wires and the horizontal wires therein pass through each other in different ways, wherein each horizontal wire first passes through two longitudinal wires and then is pressed under the next two vertical wires, the vertical wire and the horizontal wire The filaments may be aligned at an angle of 60°. Of course, each of the metal wires forming the screen according to the invention may consist of one filament, or several, for example, intertwined metal filaments.

2. Production of occluder bracket shaping mold

According to the specifications of tubular stents with different lengths and diameters, select different specifications of shaping molds, place a device that can expand or shrink inside the mesh, or make a shaping mold of a certain shape by heating, and put it inside the stent , and put the bracket with the filling inside into the corresponding shaping mold for pressing, and fix it with a clamp. Then through heat treatment at different temperatures, products with shape memory characteristics and different specifications can be obtained.

3. Combination of occluder support and fibrous material

In the present invention, the braiding technology is applied to nickel-titanium alloy wires to weave a net tubular cylindrical bracket according to a certain route on the mould. temperature to achieve the required superelasticity and memory properties.

The stent of the occluder is lined with a polyester film layer, and the polyester film and the stent are sewed together with medical sutures, put into a breathable sterilization bag, and sterilized by ethylene oxide before use.

The operation process of the occluder treatment provided by the invention is as follows:

When using the occluder for the treatment of atrial septal defect, the occluder is connected with the delivery device, pulled into the short sheath, sent into the long sheath through the short sheath, and pushed by the delivery device through the delivery sheath To the left atrium, the disc of the left atrium will be opened by its own superelasticity after being out of the sheath, and pulled back to the hole of the atrial defect. Ultrasound shows that the left atrium side of the occluder is located on the side of the left atrium. If there is resistance, fix it The delivery device retracts the sheath and releases the right atrium disk. The disks on both sides are clamped on both sides of the atrial septal defect through their own superelastic reconstruction. For example, the position of the occluder is fixed when pushing and pulling back. If the function of the adjacent part is not affected, the occluder can be released to end the operation. When performing ventricular septal defect occluder treatment, connect the occluder with the delivery device, pull it into the short sheath, send it into the long sheath through the short sheath, and push the occluder to the left side through the delivery sheath through the delivery device. At the ventricle, the disk of the left atrium and ventricle will be opened by its own superelasticity after being out of the sheath, and pulled back to the hole of the ventricular septum. Ultrasound shows that the left ventricular surface of the occluder is located on the side of the left ventricle. If there is resistance, it will be fixed and delivered The device retracts the sheath to release the right ventricular disc, and the discs on both sides are clamped on both sides of the ventricular septal defect through their own superelastic reconstruction. If the position of the occluder is fixed when pushing and pulling back, it will not If the function of the adjacent part is affected, the occluder can be released, ending the operation.

The present invention also provides a delivery device for the occluder

The delivery device of the occluder provided by the present invention is mainly composed of a sheath tube, an accommodating chamber, a connecting hook, an inner core, a spring tube, a knob screw, a rotating nut, and a fixing screw; wherein, the sheath tube is elongated , a hollow structure, an inner core is installed in an accommodating chamber, the spring tube is installed between the sheath and the accommodating chamber, one end of the inner core is connected with the knob screw, and the inner core The outer top is connected with the connecting hook, the rotating nut is connected with the knob screw through threads, and a fixing screw is installed on the rotating nut.

The connection and release of the occluder provided by the present invention and the delivery device are carried out through the following methods. Pull the inner core, pull the connecting hook and the connecting ring into the accommodation chamber, then turn the knob screw inside the inner core and turn it counterclockwise. At this time, the connecting fish connected to the inner core will slowly move towards the accommodation chamber until it completely enters the accommodation chamber; at the same time, tighten the fixing screws. When releasing, turn the knob screw in the opposite direction, gently push the inner core forward, so that the connecting hook is pushed out about 2 mm outside the housing, and then turn the inner core forward or reverse, and the connecting hook can be separated from the connecting ring of the occluder. achieve the purpose of release.

Advantages and positive effects of the present invention: a kind of occluder for congenital heart structural defect provided by the present invention adopts the advantages of previous occluders, adopts wire weaving technology to make the circle of left atrium and ventricle side Disc, to make it flat, to avoid the Amplatzer occluder currently widely used in clinical practice in the left atrium, ventricle side of the left atrium and ventricle caused by the use of fixing screws uneven left atrium, ventricle disc. In the present invention, the left and right atrium and the side of the ventricle are all braided by nickel-titanium alloy wires, and the surface is smooth and has some invaginations, which is beneficial to the formation of epithelialization after the occluder is implanted, and reduces the possible occurrence of unsmooth left atrium and ventricle. Complications of thrombosis. In addition, the occluder provided by the present invention is braided by weaving technology, and can be stretched into a line after being pulled by force, and can be sent into ventricular septal defect and atrial septal defect through a sheath tube of 6-12F. Vascular injuries were mild. That is, it only needs to incise the skin about 3mm on the outside to complete the closure treatment of ventricular septal defect and atrial septal defect.

Below, the details and working conditions of the specific device proposed according to the present invention will be described in detail in conjunction with the drawings and embodiments.

Description of drawings

Fig. 1 is the schematic diagram of the three-dimensional structure of an atrial septal defect occluder support for heart disease according to an embodiment of the present invention;

Fig. 2 is a schematic diagram of using the occluder in Fig. 1 for the structural defect of the heart of the patient;

Fig. 3 is a schematic diagram of the structure of the left atrial surface of the occluder provided in Fig. 1;

Fig. 4 is a schematic diagram of the structure of the right atrial surface of the occluder provided in Fig. 1;

Fig. 5 is a three-dimensional structural schematic diagram of a stent for a cardiac ventricular septal defect occluder provided by an embodiment of the invention;

Fig. 6 is a schematic diagram of using the occluder in Fig. 5 for the structural defect of the heart of the patient;

Fig. 7 is a schematic diagram of the structure of the left ventricle of the occluder provided in Fig. 5;

Fig. 8 is a schematic diagram of the structure of the right ventricle of the occluder provided in Fig. 5;

Fig. 9 is a three-dimensional structural schematic diagram of another asymmetric cardiac ventricular septal defect occluder stent provided by an embodiment of the present invention;

Fig. 10 is a schematic diagram of using the occluder in Fig. 9 for the structural defect of the heart of the patient;

Fig. 11 is a schematic diagram of the structure of the left ventricle of the occluder provided in Fig. 9;

Fig. 12 is a schematic diagram of the structure of the right ventricle of the occluder provided in Fig. 9;

Fig. 13 is a structural schematic diagram of a mesh-piercing mold provided by the present invention;

Fig. 14 is a schematic diagram of the cross-sectional structure at position A-A of Fig. 13;

Fig. 15 is an enlarged view of the partial structure of B in Fig. 14;

Fig. 16 is a schematic front view of the initial weaving state of the occluder bracket provided by the present invention on the mesh-piercing mold;

Figure 17 is a schematic diagram of the back of Figure 16;

Fig. 18 is a schematic diagram of the structure of the present invention braided into a network tubular cylinder;

Fig. 19 is a structural schematic diagram of the present invention when weaving converges;

Fig. 20 is a schematic diagram of the structure in direction C of Fig. 19;

Fig. 21 is an enlarged view of the partial structure of G in Fig. 20;

Figure 22 is a schematic structural view of the heat treatment mold used in the embodiment of the present invention;

Fig. 23 is a shape change diagram of the occluder provided by the present invention completely pulled into the delivery sheath;

Fig. 24 is a linear change diagram of the occluder provided by the present invention when it is pulled into the delivery sheath;

Fig. 25 is a diagram of the shape change of the occluder provided by the present invention when it is pushed out about 1/3 from the delivery sheath;

Fig. 26 is a shape change diagram of the sheath tube pushed out by the front half of the occluder provided by the present invention, the left disc of the occluder is fully opened and is in the shape of a disc;

Figure 27 shows the shape change of the occluder provided by the present invention when it is fully pushed out of the sheath. After the occluder is completely pushed out of the sheath, it returns to the original double disc shape through its own superelasticity and shape memory function;

Figure 28 is a schematic structural view of the delivery device provided by the present invention;

FIG. 29 is an enlarged view of the partial structure in FIG. 28 .

Fig. 30 is a partially enlarged schematic diagram of the stent mesh of the occluder used in the present invention.

Fig. 31 is an enlarged schematic view of another mesh of the occluder stent used in the present invention.

Detailed ways

As shown in the accompanying drawings, an occluder for congenital heart structural defects provided by an embodiment of the present invention is composed of a metal braid stent and a built-in fibrous substance that blocks blood flow, wherein the metal braid The object support is all braided by metal wires, which has a preset expanded shape, the shape of the occluder can occlude the defect of the abnormal structure, and the preset expanded shape can be deformed into a smaller cross-sectional shape, For delivery through the blood vessels and heart of a patient, the metal braid has memory properties such that when unrestrained, the occluder returns to the preset expanded configuration.

An occluder for congenital heart structural defects provided by the embodiment of the present invention is mainly used for congenital heart disease such as ventricular septal defect, atrial septal defect, patent ductus arteriosus and other symptoms, which is a common congenital heart disease , a lesion characterized by the failure of the septum between the left and right atria and the left and right ventricles to close normally after birth.

An occluder for congenital heart structural defect provided by the embodiment of the present invention can be divided into ventricular septal defect occluder and atrial septal defect occluder, which are composed of superelastic memory alloy wire and polyester fiber membrane . The nitinol wire is the occluder holder; the polyester fiber membrane is lined in the middle to block the blood flow.

An occluder bracket for congenital heart structural defects provided by the present invention mainly includes a net tubular cylindrical bracket waist, and circular planes located on the left and right sides of both ends of the bracket, the circular planes There are fixed gathering points in the center, and a braided connecting ring is connected to one of the fixed gathering points.

A shape for congenital structural defects of the heart provided by the embodiment of the present invention mainly includes left and right double-sided discs, and a waist connecting the two discs, the waist is cylindrical, and the disc is larger than the disc. The waist diameter is large.

The double-sided disk of the present invention is formed by braiding technology to form a flat plane, and the center point of the left plane is surrounded by the turns of the nickel-titanium alloy wires forming the bracket, and the nickel-titanium wires of the bracket itself are circularly penetrated. Each turnback makes it connected into a complete whole, and the center point of the left disk is gathered together by a nickel-titanium alloy wire to form a small bundle of gathering points, which repeatedly circles through the turnback to form a Strong anchor loops. There is no riveting on the surface of the bracket, and the structure is firm and the shape is reasonable. The central point of the right disk is used to gather the rings together through nickel-titanium alloy wires to form a small bundle of gathering points, which are repeatedly looped through the folded rings to form a firm fixation loop. The nickel-titanium wire composed of the present invention passes through the fixation loop many times to make a connecting ring connected with the fixation loop.

The embodiment of the present invention provides a manufacturing method of the occluder.

1. Fabrication of the occluder bracket

1. Production of mesh mold

Weaving molds are generally made of strong and easy-to-manufacture metal materials, such as stainless steel, chrome stainless steel, metal alloys and other materials.

(1) According to the requirements of the preset expanded shape, make a braiding mold, the braiding mold can generally be processed into the shape of a metal cylinder; the shape of the metal cylinder can be designed according to the preset shape of the occluder bracket , for occluders such as ventricular septal defect, atrial septal defect, and patent ductus arteriosus provided by the embodiments of the present invention, it is preferable to make a metal cylinder with a diameter D of 3-50 mm

(2) Process some equally divided grooves with certain graduations on the surface of the metal cylinder. Generally, the number of grooves on the cylinder is required to be an even number, and the number of the above-mentioned grooves cannot be too small, otherwise it will not be possible. Generally, at least 20 or more stents are required to weave into a mesh-shaped cylinder, and the preferred number of grooves is 4N, where 7≤N≤20.

The above-mentioned grooves can be various grooves such as triangular grooves and semicircular grooves. The above-mentioned grooves can be grooved by an indexer groover.

The concavo-convex parts can preferably be arranged in equal parts, and they can also be arranged in a ratio of 1-2:1-2.

(3) Punch holes between the upper and lower ends of the metal cylinder to fix the fixed folded portion of the woven net. The fixed folded portion can be a small nail, a small needle, etc., half of which are embedded in the metal cylinder, and half of which are left On the outside, metal wires can be wound, and all the fixed turning parts can be opened in the groove or outside the groove, and the distance L between the upper and lower fixed turning parts is preferably 4-150 mm.

2. Fabrication of the occluder bracket

(1) Take the wire head of a metal wire, start the metal wire around the upper end turning part 21, and cling to the mould, rotate 360 degrees clockwise with a slope of 30-60 degrees, evenly up and down Wrap around to the lower turn-back portion 21' corresponding to the upper end 21;

(2) After bypassing the lower end turning part 21 ', then go around the upper end turning part 22 from the lower end close to the mould, in a counterclockwise direction;

(3) Go around the above-mentioned upper end turning part 22 similarly, and then go around to the lower end turning part 22' by the same method as above, and repeat like this until the entire above-mentioned mesh passing mold is wound around. After removing the turning part, a Mesh-tubular cylindrical metal stent.

The above-mentioned mesh-shaped cylindrical stent can be woven by a nickel-titanium metal wire back and forth at a certain angle without interruption. One end of the tubular cylindrical metal stent will eventually retain two longer wire ends.

3. Fabrication of the fixing rings at both ends of the occluder bracket

(1) Utilize the two pieces of wire left on the mesh-shaped upper port of the above-mentioned mesh-shaped cylindrical metal bracket, one end is in a clockwise direction, and the other end is wound in a counterclockwise direction along the mesh-shaped upper port, and the ring of the upper port is folded back The rings are folded together, and repeatedly looped through the folded rings to tighten the two pieces of wire, forming a circle of fixed gathering points at the upper end of the mesh.

(2) Still using these two pieces of wire, according to the original weaving method of the mesh shape, weave overlappingly along the two wires in the center of the mesh shape to the lower end of the mesh shape of the above-mentioned mesh-shaped cylindrical metal bracket, and use the same method as the upper mesh weaving method. According to the method, a fixed cluster point small circle can also be harvested at the lower mouth end of the net shape.

(3) Repeatedly looping through the folded ring can form a firm fixed loop point at the upper and lower ends of the net tubular cylinder; after the final small circle is harvested, use one of the threads to pass through the small circle and go back and forth many times , forming a ring, using another wire to wind a rope-like ring on the ring until it intersects with another wire, and after several times of weaving and finishing, a connecting ring is formed.

Then heat it for heat treatment to preliminarily determine the network shape, so as to facilitate the processing of the subsequent process.

2. Production of occluder bracket shaping mold

According to the specifications of tubular stents with different lengths and diameters, select different specifications of shaping molds, place a device that can expand or shrink inside the mesh, or make a shaping mold of a certain shape by heating, and put it inside the stent , and put the bracket with the filling inside into the corresponding shaping mold for pressing, and fix it with a clamp. Then through heat treatment at different temperatures, products with shape memory characteristics and different specifications can be obtained.

3. Combination of occluder support and fibrous material

In the present invention, the braiding technology is applied to nickel-titanium alloy wires to weave a net tubular cylindrical bracket according to a certain route on the mould. temperature to achieve the required superelasticity and memory properties.

The stent of the occluder is lined with a polyester film layer, and the polyester film and the stent are sewed together with medical sutures, put into a breathable sterilization bag, and sterilized by ethylene oxide before use.

The present invention also provides a delivery device for the occluder

As shown in accompanying drawings 28-29, the delivery device 30 of the occluder provided by the present invention is mainly composed of a sheath tube 31, an accommodating chamber 32, a connecting hook 33, an inner core 34, a spring tube 35, a knob screw 36, a rotating nut 37, Fixing screws 38 and other parts; wherein, the sheath tube 31 is a slender, hollow structure, and there is an inner core 34 installed inside the sheath tube 31, and the sheath tube 31 and the accommodation chamber 32 are installed with a The spring tube 34 described above, one end of the inner core 34 is connected with the knob screw 36, the outer top end of the inner core 34 is connected with the connecting hook 33, and the rotating nut 37 is threaded with the Knob screws 36 are connected, and a fixing screw 38 is also installed on the rotating nut 37 .

The connection and release of the occluder provided by the present invention and the delivery device are carried out by the following method. When connecting with the occluder, first connect the connecting ring of the occluder to the connecting hook 33, Pull the inner core 34, pull the connecting hook 33 and the connecting ring into the accommodation chamber 32, and then turn the knob screw 36 in the inner core 34 to rotate counterclockwise. At this time, the connecting hook 33 connected to the inner core 34 will slowly move into the accommodation chamber 32 until it completely enters the accommodation chamber 32 ; at the same time, tighten the fixing screw 38 . When releasing, turn the knob screw 36 in the reverse direction, push the inner core 34 forward slightly, so that the connecting hook 33 is pushed out about 2 mm outside the accommodation chamber 32, and then turn the inner core forward or reverse, and the connecting hook 33 can be connected with the blocking The connecting ring of the device is separated to achieve the purpose of release.

As shown in accompanying drawings 23-27, the use state of a kind of occluder for congenital heart structural defect provided by the present invention is as follows:

Fig. 23 is a shape change diagram of the occluder provided by the present invention completely pulled into the delivery sheath;

Fig. 24 is a linear change diagram of the occluder provided by the present invention when it is pulled into the delivery sheath;

Fig. 25 is a diagram of the shape change of the occluder provided by the present invention when it is pushed out about 1/3 from the delivery sheath;

Fig. 26 is a shape change diagram of the sheath tube pushed out by the front half of the occluder provided by the present invention, the left disc of the occluder is fully opened and is in the shape of a disc;

Figure 27 shows the shape change of the occluder provided by the present invention when it is fully pushed out of the sheath. After the occluder is completely pushed out of the sheath, it returns to the original double disc shape through its own superelasticity and shape memory function;

The double-sided disc of the present invention forms a flat plane through wire weaving technology, and the center point of the left plane is surrounded by the turn-back of the nickel-titanium alloy wire forming the bracket, and the center of the left disc is The points are gathered together by nickel-titanium alloy wires to form a small bundle of gathering points, which are repeatedly looped through the folded rings to form a firm fixed loop. And the nickel-titanium wire of the stent itself runs through each of the folded rings to make it connected into a complete whole. There is no riveting on the surface of the stent, and its structure is firm and its shape is reasonable. The central point of the right disk is used to gather the rings together through nickel-titanium alloy wires to form a small bundle of gathering points, which are repeatedly looped through the folded rings to form a firm fixation loop. Then, a nickel-titanium wire is passed through the haptics several times to make a cord-shaped ring perpendicular to the haptics, with a diameter of about 2-4mm. Wherein, the function of the connecting ring 3 on the right disc is to connect with the delivery device for delivery and release.

Example 1

The diameter of the secundum atrial septal defect is 15mm, and its edge is more than 5mm away from the top of the atrium, the mitral valve, the tricuspid valve, and the opening of the pulmonary vein. Use an atrial septal defect occluder with a waist diameter D = 15mm. The diameter of the disc on the left atrium side of the occluder is 29 mm, and the diameter of the disc on the right atrium side is 26 mm.

As shown in the accompanying drawings 1-4, the embodiment of the present invention provides an atrial septal defect occluder for congenital heart disease, which is composed of a nickel-titanium alloy wire stent 1 and a polyester fiber membrane 2 .

The atrial septal defect occluder provided by the present invention is composed of a superelastic nickel-titanium alloy wire stent 1 and a polyester fiber membrane 2; wherein, the nickel-titanium alloy wire is the occluder stent 1; the polyester fiber The membrane 2 is lined in the middle of the occluder stent 1; one end of the occluder stent 1 has a nickel-titanium alloy wire to form the connecting ring 3a, which is used to connect with the delivery device. The occluder stent 1 can be placed at the defect position between the left atrium 15 and the right atrium 17 .

The outer shape of the atrial septal defect occluder bracket 1 provided by the present invention is a double-sided disc shape, the waist 4a connecting the two discs is cylindrical, and the diameters of the discs 5a, 7a are larger than the waist 4a. The left atrium side 5a of the occluder stent 1 is in the shape of an indented flat disc, and the right atrium side 7a is also in the shape of a flat indented disc, and is connected with the connecting ring 3a.

As shown in Figures 3-4, the disk surface 5a on the left atrium side described in the atrial septal defect occluder for congenital heart disease provided by the embodiment of the present invention forms a flat plane through wire braiding technology. , the center of the plane is the confluence 6a of the ring-shaped turns of the braided wire of the stent, and the nickel-titanium alloy wire constituting the stent itself runs through each ring-shaped turn-back ring to make it connected as a whole, and there is no riveting on the surface of the stent. In addition, the disc is connected to an integral occluder bracket 1 through the nickel-titanium alloy wire that constitutes the bracket itself and runs through each annular turn-back ring at the center of the disc. As shown in the accompanying drawings, the disc surface 5 on the left atrium side is in the shape of a blooming lotus flower, and the disc surface 5a on the left atrium side has a central intersection point 6a of nickel-titanium alloy wires, which can greatly strengthen the surface of the plane. Stressed structure, its structure is firm, its shape is reasonable, and it has strong supporting force.

The right atrium side 7a provided by the embodiment of the present invention is also in the shape of a flat disc, and is connected with the connecting ring 3a. Through the wire braiding technique, a flat plane is formed, and the center of the plane is the ring of the braided wire of the stent The folded converging point 8a is connected as a whole through the nickel-titanium alloy wire forming the bracket itself through each annular folded ring, and there is no riveting on the surface of the bracket.

The nickel-titanium alloy wire stent 1 for the atrial septal defect occluder for congenital heart disease provided by the embodiment of the present invention can be manufactured by the following fabrication method:

1. The manufacture of the occluder bracket, as shown in Figures 13-15,

1. Stainless steel materials are used for the production of mesh molds

(1) According to the structure of the atrial septal defect of congenital heart disease, the requirements of the preset expanded shape are made to make a weaving mold, and the weaving mold can be processed into a metal cylinder shape, with D=15mm and a length of 40-80mm;

(2) process 36 equally divided grooves on the surface of the metal cylinder;

(3) Get 36 equally divided turn-backs and 20 nails in the grooves at both ends of L=40mm in the metal cylinder, each punched to fix the braided net.

2. The manufacture of the occluder bracket, as shown in Figures 16-17,

(1) Take the wire head of a long metal wire, start the metal wire around the upper-end turning part 21, cling to the mould, rotate 360 degrees clockwise with a slope of 30 degrees, and follow the "S" The shape is evenly wound up and down to the lower end turning part 21' corresponding to the upper end 21;

(2) After bypassing the lower end turning part 21 ', then go around the upper end turning part 22 from the lower end close to the mould, in a counterclockwise direction;

(3) Also bypass the above-mentioned upper end turning part 22, and then go around to the lower end turning part 22' by the same method as above, and so on and on, until the entire above-mentioned meshing mold is wound around, and after removing the turning part 20, it can be formed A mesh-like cylindrical metal bracket. As shown in Figure 18.

The wire mesh in the occluder stent 1 provided by the embodiment of the present invention can pass the longitudinal wires and the horizontal wires through each other to form small diamond-shaped boxes. As shown in accompanying drawing 31, the longitudinal wires and the horizontal wires wherein each horizontal wire first passes through two longitudinal wires and then presses under the next two vertical wires, and each vertical wire first passes through two horizontal wires Then press it under the two horizontal wires next to it.

It can be seen that the above-mentioned mesh-shaped cylindrical support can be woven by a nickel-titanium metal wire back and forth without interruption. In the two ends of the shaped metal support, one end will finally retain two longer wire ends. As shown in Figure 18.

3. Fabrication of the fixed structures at both ends of the occluder bracket, as shown in Figures 19-21.

(1) Utilize the two sections of silk left on the disc surface 5a on the left atrium side of the mesh-shaped upper port of the above-mentioned mesh-shaped cylindrical metal stent, one end from the clockwise direction and the other end in the counterclockwise direction to face each other along the mesh-shaped upper port Wrapping, gather the looped loops of the upper port together, repeatedly loop through the loops, tighten the two pieces of wire, and form a fixed cluster point circle 6a at the top end of the net shape.

(2) Still using these two pieces of wire, according to the original weaving method of the mesh shape, weave the two wires along the center of the mesh shape at a 30° overlap to the right atrium side circle at the lower mouth end of the above-mentioned mesh-shaped cylindrical metal stent mesh Disc surface 7a, with the same method as upper mouth weaving, can also harvest a fixed cluster point small circle 8a at the lower mouth end of net shape.

(3) Repeatedly looping through the folded rings can form a firm fixed loop point 6a, 8a at the upper and lower ends of the net tubular cylinder; after the small circle 8a is finally harvested, use one of the wires to pass through the small circle , going back and forth multiple times to form a loop, using another wire to wind a rope-like loop on the loop until it intersects with another wire, and after several times of weaving and finishing, a connecting ring 3a is formed. The connecting ring 3a is a cable-shaped ring perpendicular to the fixed haptic point, and its diameter is 3mm.

Then heat it for heat treatment to preliminarily determine the network shape, so as to facilitate the processing of the subsequent process.

2. Production of occluder bracket shaping mold

According to the specifications of tubular stents with different lengths and diameters, select different specifications of shaping molds, place a device that can expand or shrink inside the mesh, or make a shaping mold of a certain shape by heating, and put it inside the stent , and put the bracket with the filling inside into the corresponding shaping mold for pressing, and fix it with a clamp. Then through heat treatment at different temperatures, products with shape memory characteristics and different specifications can be obtained.

3. Combination of occluder support and fibrous material

In the present invention, the braiding technology is applied to nickel-titanium alloy wires to weave a net tubular cylindrical bracket according to a certain route on the mould. temperature to achieve the required superelasticity and memory properties.

The stent 1 of the occluder is lined with a polyester film layer 2, and the polyester film 2 and the stent 1 are sewed together with medical sutures, put into a breathable sterilization bag and sterilized by ethylene oxide for use.

Example 2

Perimembranous ventricular septal defect, the diameter of the defect is 5 mm, and the distance from the upper edge of the defect to the aortic valve and tricuspid valve is 3 mm. A symmetrical ventricular septal defect occluder with a waist diameter of D = 6 mm was selected. The diameter of the discs on the left and right sides of the occluder is 10mm.

As shown in accompanying drawings 5-8, the embodiment of the present invention provides an occluder for cardiac ventricular septal defect, which is composed of a nickel-titanium alloy wire stent 1 and a polyester fiber membrane 2 . Wherein, the nickel-titanium alloy wire is the occluder stent 1; the polyester fiber membrane 2 is lined in the middle of the occluder stent 1 to block blood flow; the occluder stent 1 There is a nickel-titanium alloy wire at one end to form the connecting ring 3b, which is used to connect with the delivery device 30. Wherein, 21 is the aorta, and 22 is the pulmonary artery, and the occluder stent 1 can be placed at the defect position between the left ventricle 25 and the ventricle 27 .

As shown in the accompanying drawings 5-8, the embodiment of the present invention provides a symmetrical occluder for cardiac ventricular septal defect, which is a stent 1 braided by nickel-titanium alloy wires, mainly including facing opposite symmetrical occluders The left ventricle disc 5b of the occluder and the right ventricle disc 7b of the occluder, the waist 4b of the occluder connecting the left ventricular disc 5b of the above-mentioned occluder and the right ventricle disc 7b of the occluder; wherein, the The left ventricle disc 5b of the occluder and the right ventricle disc 7b of the occluder are symmetrical structures, the left ventricular disc 5b of the occluder is a flat and indented disc, and the occluder The right ventricle disc 7b is also a flat and indented disc, on which the braided connecting ring 3b is also connected.

As shown in the accompanying drawings 7-8, the disc surface 5b on the left ventricle side of the novel cardiac ventricular septal defect occluder provided by the embodiment of the present invention forms a flat plane through weaving technology, and the center 6b of the plane is The confluence of the circular turns of the braided wires of the stent is connected as a whole through the nickel-titanium alloy wires constituting the stent itself through the various circular turns, and there is no riveting on the surface of the stent. In addition, the disc is connected to an integral occluder bracket 1 through the nickel-titanium alloy wire that constitutes the bracket itself and runs through each annular turn-back ring at the center of the disc. As shown in the accompanying drawings, the disk surface 5b on the left ventricle side is shaped like a blooming lotus flower, and the above-mentioned disk surface 5b on the left atrium side has a central intersection point 6b of nickel-titanium alloy wires, which can greatly strengthen the surface of the plane. Stressed structure, its structure is firm, its shape is reasonable, and it has strong supporting force.

In the embodiment of the present invention, the side of the right ventricle disc 7b is also in the shape of a flat disc, and is connected with the connecting ring 3b. Through the braiding technology of metal wires, a flat plane is formed, and the center of the plane is the ring shape of the stent braided wire. The folded converging point 8b is connected as a whole through the nickel-titanium alloy wire forming the stent itself through each annular folded ring, and there is no riveting on the surface of the stent. The central point of the disc 7b on the side of the right ventricle is used to gather the ring-shaped loops together through nickel-titanium alloy wires to form a small bundle of gathering points, which are repeatedly looped through the loops to form a firm fixed loop 8b.

A nickel-titanium alloy wire stent 1 for a symmetrical occluder for cardiac ventricular septal defect provided by the embodiment of the present invention can be manufactured by the following fabrication method:

1. The manufacture of the occluder bracket, as shown in Figures 13-15,

1. Stainless steel materials are used for the production of mesh molds

(1) According to the structure of the symmetric occluder for ventricular septal defect in congenital heart disease, the requirements of the expanded profile are preset to make the braiding mold 10, and the braiding mold 10 can be processed into a metal cylinder shape, its D=6mm, length 20-40mm;

(2) process 32 equally divided grooves on the surface of the metal cylinder;

(3) Take 32 equally divided turning parts 20 of each perforated and fixed braided net in the grooves at both ends of L=20mm in the metal cylinder.

2. The manufacture of the occluder bracket, as shown in Figures 16-17,

(1) Take the wire head of a long metal wire, start the metal wire around the upper-end turning part 21, cling to the mould, rotate 360 degrees clockwise at a slope of 60 degrees, and follow the "S" The shape is evenly wound up and down to the lower end turning part 21' corresponding to the upper end 21;

(2) After bypassing the lower end turning part 21 ', then go around the upper end turning part 22 from the lower end close to the mould, in a counterclockwise direction;

(3) Also bypass the above-mentioned upper end turning part 22, and then go around to the lower end turning part 22' by the same method as above, and so on and on, until the entire above-mentioned meshing mold is wound around, and after removing the turning part 20, it can be formed A mesh-like cylindrical metal bracket. As shown in Figure 18.

The wire mesh in the occluder stent 1 provided by the embodiment of the present invention can pass the longitudinal wires and the horizontal wires through each other to form small diamond-shaped boxes. As shown in accompanying drawing 30, wherein the longitudinal wire and the transverse wire pass through each other, and press each other below every other time.

It can be seen that the above-mentioned mesh-shaped cylindrical support can be woven by a nickel-titanium metal wire back and forth without interruption. In the two ends of the shaped metal support, one end will finally retain two longer wire ends. As shown in Figure 18.

3. Fabrication of fixed structures at both ends of the occluder bracket

(1) Utilize the two sections of wire left on the disc surface 5b of the left ventricle disc at the mesh-shaped upper port of the mesh-shaped cylindrical metal stent, one end goes clockwise, and the other end goes counterclockwise, facing each other along the mesh-shaped upper port Wrapping, gathering the looped loops of the upper port together, repeatedly looping through the loops, tightening the two pieces of wire, and forming a fixed cluster point circle 6b at the top end of the mesh.

(2) Still using these two pieces of wire, according to the original weaving method of the mesh shape, weave the two wires along the center of the mesh shape at an overlapping angle of 60° to the right ventricular disc at the lower opening end of the mesh-shaped cylindrical metal stent above. 7b, using the same method as the weaving of the upper mouth, a small circle 8b of fixed converging points can also be harvested at the lower mouth of the net-shaped right ventricle disc 7b.

(3) Repeatedly looping through the folded rings can form a firm fixed loop point 6b, 8b at the upper and lower ends of the net tubular cylinder; after the small circle 8b is finally harvested, use one of the wires to pass through the small circle , going back and forth multiple times to form a loop, using another wire to wind a rope-like loop on the loop until it intersects with another wire, and after several times of weaving and finishing, a connecting ring 3b is formed, The connecting ring circle 3b is a cord-shaped ring perpendicular to the fixed haptic point 8a, and its diameter is 3mm.

Then heat it for heat treatment to preliminarily determine the network shape, so as to facilitate the processing of the subsequent process.

Of course, it can also be made by:

(1) Utilize the two pieces of wire left on the upper opening of the above-mentioned net-shaped cylindrical metal bracket, one end goes in a clockwise direction, and the other end goes in a counterclockwise direction, and wraps around the upper opening of the net for one and a half circles. The intersecting mesh goes up and down one by one, so that the two pieces of silk are just in the opposite position of the mesh-shaped catch, and the two pieces of silk are tightened, and the mesh-shaped catch forms a very small circle.

(2) Still use these two pieces of wire, according to the original weaving method of the mesh shape, weave overlappingly along the two wires in the center of the mesh shape to the lower opening of the above-mentioned mesh-shaped cylindrical metal bracket mesh, and use the same method as the upper opening , and the lower mouth is also harvested into a small circle.

(3) After the small circle is harvested, use one of the threads to pass through the small circle, go back and forth three times to form a ring, use the other thread to wind a rope-like ring on the ring, until it is connected with another The root filaments intersect and are braided many times to form a connecting ring.

2. Production of occluder bracket shaping mold

According to the specifications of tubular stents with different lengths and diameters, select different specifications of shaping molds, place a device that can expand or shrink inside the mesh, or make a shaping mold of a certain shape by heating, and put it inside the stent , and put the bracket with the filling inside into the corresponding shaping mold for pressing, and fix it with a clamp. Then through heat treatment at different temperatures, products with shape memory characteristics and different specifications can be obtained.

3. Combination of occluder support and fibrous material

In the present invention, by applying the weaving technology to nickel-titanium alloy wires, weaving a net tube-shaped cylindrical bracket according to a certain route on the mold, after fixing both ends, putting it between 5 inner and outer moulds, forming double disks after heat treatment, and controlling Process temperature to achieve desired superelasticity and memory properties.

The stent 1 of the occluder is lined with a polyester film layer 2, and the polyester film and the stent are sewed together with medical sutures, put into a breathable sterilization bag and sterilized by ethylene oxide for use.

Example 3

Perimembranous ventricular septal defect, defect diameter 4mm, defect upper edge 2mm from the aortic valve, 3mm from the tricuspid valve. An asymmetric ventricular septal defect occluder with a waist diameter of D = 5 mm was selected. The upper edge of the disc on the left side of the occluder is 0.5mm larger than the waist, and the lower edge is 5.5mm larger than the waist.

As shown in accompanying drawings 9-12, a new type of asymmetric occluder for ventricular septal defect provided by the embodiment of the present invention, the stent 1 braided by nickel-titanium alloy wire mainly includes asymmetric occluders facing each other The left ventricle disc 5c of the device and the right ventricle disc 7c of the occluder, the waist 4c of the occluder that connects the left ventricle disc 5c of the above-mentioned occluder and the right ventricle disc 7c of the occluder, and the One end of the plug has a nickel-titanium alloy wire to form the connecting ring 3, which is used to connect with the delivery device 30. Wherein, the shape of the occluder is an asymmetrical double-disc shape, the waist 4c connecting the two discs is cylindrical, the left and right discs are larger in diameter than the waist 4c, and the disc 5c on the left ventricle side is at the side edge of the aortic valve and the cylinder. The parts are equal, the opposite side is 6mm larger than the cylindrical part, and the edge of the disk 7c on the right ventricle side is 4mm larger than the cylindrical diameter, which is a symmetrical distribution. Wherein, 21 is the aorta, and 22 is the pulmonary artery, and the occluder stent 1 can be placed at the defect position between the left ventricle 25 and the ventricle 27 .

As shown in Figures 11-12, the disk surface 5c on the left ventricle side of the novel cardiac ventricular septal defect occluder provided by the embodiment of the present invention forms a smooth plane through metal braiding technology, and the center of the plane The confluence 7 of the ring-shaped folds of braided wires for the stent is connected as a whole through the nickel-titanium alloy wires that make up the stent itself through the ring-shaped folds, and there is no riveting on the surface of the stent. In addition, the disc is connected to an integral occluder bracket 1 through the nickel-titanium alloy wire that constitutes the bracket itself and runs through each annular turn-back ring at the center of the disc. As shown in the accompanying drawings, the disc surface of the left ventricle side 5c is in the shape of a blooming lotus flower. The disc surface 5c of the left atrium side has a central intersection point 6c of nickel-titanium alloy wires, which can greatly strengthen the surface of the plane. Stressed structure, its structure is firm, its shape is reasonable, and it has strong supporting force. The disc surface 5c on the side of the left ventricle of the occluder has a good shape memory function, and is linear when pulled by an external force, and returns to its original shape immediately after the external force is removed.

In the embodiment of the present invention, the side of the right ventricle disk 7c is also flat and disc-shaped, and is connected with the connecting ring 3c. Through the wire braiding technology, a flat plane is formed, and the center of the plane is the ring of the stent braided wire. The converging point 8c of the fold is connected as a whole through the nickel-titanium alloy wire forming the bracket itself through each annular fold ring, and there is no riveting on the surface of the bracket. The central point of the disc 7c on the side of the right ventricle is folded together by a nickel-titanium alloy wire to form a small bundle of gathering points, which repeatedly circles through the folded ring to form a firm fixing loop 8c.

A nickel-titanium alloy wire stent 1 for an asymmetric occluder for cardiac ventricular septal defect provided by the embodiment of the present invention can be manufactured by the following fabrication method:

1. The manufacture of the occluder bracket, as shown in Figures 13-15,

1. Metal aluminum alloy materials are used for the production of mesh molds

(1) According to the structure of the asymmetric occluder for ventricular septal defect in congenital heart disease, the requirements of the expanded profile are preset to make the weaving mold 10, and the weaving mold 10 can be processed into a metal cylinder shape, and its D=5mm, The length is 10-40mm;

(2) Process 28 equally divided grooves on the surface of the metal cylinder;

(3) Get 28 equally divided turning parts and 20 small needles in the grooves at both ends of L=18mm in the metal cylinder to punch holes and fix the braided net.

2. The manufacture of the occluder bracket, as shown in Figures 16-17,

(1) Take the wire head of a long metal wire, start the metal wire around the upper end turning part 21, and cling to the mould, rotate 360 degrees clockwise with a slope of 45 degrees, according to "S" The shape is evenly wound up and down to the lower end turning part 21' corresponding to the upper end 21;

(2) After bypassing the lower end turning part 21 ', then go around the upper end turning part 22 from the lower end close to the mould, in a counterclockwise direction;

(3) Also bypass the above-mentioned upper end turning part 22, and then go around to the lower end turning part 22' by the same method as above, and so on and on, until the entire above-mentioned meshing mold is wound around, and after removing the turning part 20, it can be formed A mesh-like cylindrical metal bracket. As shown in Figure 18.

The wire mesh in the occluder stent 1 provided by the embodiment of the present invention can pass the longitudinal wires and the horizontal wires through each other to form small diamond-shaped boxes. As shown in accompanying drawing 30, wherein the longitudinal wire and the transverse wire pass through each other, and press each other below every other time.

The above-mentioned mesh-shaped cylindrical bracket can be woven by a nickel-titanium metal wire back and forth without interruption. The diameter of the mold, the height of the mesh shape, and the angle of the mesh shape should form a preset expanded structure. In the two ends, one end will finally retain the longer two wire ends. As shown in Figure 18.

3. Fabrication of fixed structures at both ends of the occluder bracket

(1) Utilize the two pieces of wire left on the disc surface 5c of the left ventricle disk at the mesh-shaped upper port of the mesh-shaped cylindrical metal stent, one end goes clockwise, and the other end faces each other along the mesh-shaped upper port Wrapping, gathering the looped loops of the upper port together, repeatedly looping through the loops, tightening the two pieces of wire, and forming a fixed cluster point circle 6c at the top end of the mesh.

(2) Still using these two pieces of wire, according to the original weaving method of the mesh shape, weave the two wires along the center of the mesh shape at an overlapping angle of 45° to the right ventricular disc at the lower opening end of the above-mentioned mesh-shaped cylindrical metal stent mesh 7c, with the same method as the upper mouth weaving, a fixed cluster point small circle 8c can also be harvested at the lower mouth end right ventricle disc 7c of the mesh shape.

(3) Repeatedly looping through the folded rings can form a firm fixed loop point 6c, 8c at the upper and lower ends of the net tubular cylinder; after the small circle 8c is finally harvested, use one of the wires to pass through the small circle , going back and forth multiple times to form a loop, using another wire to wind a rope-like loop on the loop until it intersects with another wire, and after several times of weaving and finishing, a connecting ring 3c is formed, The diameter of the connecting ring 3c is 2mm.

Then heat it for heat treatment to preliminarily determine the network shape, so as to facilitate the processing of the subsequent process.

2. Production of occluder bracket shaping mold

According to the specifications of tubular stents with different lengths and diameters, select different specifications of shaping molds, place a device that can expand or shrink inside the mesh, or make a shaping mold of a certain shape by heating, and put it inside the stent , and put the bracket with the filling inside into the corresponding shaping mold for pressing, and fix it with a clamp. Then through heat treatment at different temperatures, products with shape memory characteristics and different specifications can be obtained.

3. Combination of occluder support and fibrous material

In the present invention, the braiding technology is applied to nickel-titanium alloy wires to weave a net tubular cylindrical bracket according to a certain route on the mould. temperature to achieve the required superelasticity and memory properties.

The stent 1 of the occluder is lined with a polyester film layer 2, and the polyester film 2 and the stent 1 are sewed together with medical sutures, put into a breathable sterilization bag and sterilized by ethylene oxide for use.

Example 4

The diameter of the secundum atrial septal defect is 34mm, and its edge is more than 5mm away from the top of the atrium, the mitral valve, the tricuspid valve, and the opening of the pulmonary vein. Use an atrial septal defect occluder with a waist diameter D = 36mm. The diameter of the disk on the left atrium side of the occluder is 50mm, and the diameter of the disk on the right atrium side is 48mm.

As shown in the accompanying drawings 1-4, the embodiment of the present invention provides an atrial septal defect occluder for congenital heart disease, which is composed of a nickel-titanium alloy wire stent 1 and a polyester fiber membrane 2 .

The atrial septal defect occluder provided by the present invention is composed of a superelastic nickel-titanium alloy wire stent 1 and a polyester fiber membrane 2; wherein, the nickel-titanium alloy wire is the occluder stent 1; the polyester fiber The membrane 2 is lined in the middle of the occluder stent 1; one end of the occluder stent 1 has a nickel-titanium alloy wire to form the connecting ring 3a, which is used to connect with the delivery device. The occluder stent 1 can be placed at the defect position between the left atrium 15 and the right atrium 17 .

The outer shape of the atrial septal defect occluder bracket 1 provided by the present invention is a double-sided disc shape, the waist 4a connecting the two discs is cylindrical, and the diameters of the discs 5a, 7a are larger than the waist 4a. The left atrium side 5a of the occluder stent 1 is in the shape of a flat disc, and the right atrium side 7a is also in the shape of a flat disc, and is connected with the connecting ring 3a.

As shown in Figures 3-4, the disk surface 5a on the left atrium side described in the atrial septal defect occluder for congenital heart disease provided by the embodiment of the present invention forms a flat plane through wire braiding technology. , the center of the plane is the confluence 6a of the ring-shaped turns of the braided wire of the stent, and the nickel-titanium alloy wire constituting the stent itself runs through each ring-shaped turn-back ring to make it connected as a whole, and there is no riveting on the surface of the stent. In addition, the disc is connected to an integral occluder bracket 1 through the nickel-titanium alloy wire that constitutes the bracket itself and runs through each annular turn-back ring at the center of the disc. As shown in the accompanying drawings, the disc surface 5 on the left atrium side is in the shape of a blooming lotus flower, and the disc surface 5a on the left atrium side has a central intersection point 6a of nickel-titanium alloy wires, which can greatly strengthen the surface of the plane. Stressed structure, its structure is firm, its shape is reasonable, and it has strong supporting force.

The right atrium side 7a of the present invention is also in the shape of a flat disc, and is connected with the connecting ring 3a. Through the wire braiding technique, a flat plane is formed, and the center of the plane is the confluence of the circular folds of the braided wire of the stent 8a, the nickel-titanium alloy wire constituting the stent itself runs through each annular folded ring to make it connected as a whole, and there is no riveting on the surface of the stent.

The nickel-titanium alloy wire stent 1 for the atrial septal defect occluder for congenital heart disease provided by the embodiment of the present invention can be manufactured by the following fabrication method:

1. The manufacture of the occluder bracket, as shown in Figures 13-15,

1. Stainless steel materials are used for the production of mesh molds

(1) According to the structure of the atrial septal defect of congenital heart disease, the requirements of the preset expanded shape are made to make a weaving mold, and the weaving mold can be processed into a metal cylinder shape, with D=36mm and a length of 60-80mm;

(2) Process 72 equally divided grooves on the surface of the metal cylinder;

(3) Take 20 small stainless steel sticks of 72 equally divided turning parts of the braided net in the grooves at both ends of L=60mm in the metal cylinder.

2. The manufacture of the occluder bracket, as shown in Figures 16-17,

(1) Take the wire head of a long metal wire, start the metal wire around the upper-end turning part 21, cling to the mould, rotate 360 degrees clockwise at a slope of 60 degrees, and follow the "S" The shape is evenly wound up and down to the lower end turning part 21' corresponding to the upper end 21;

(2) After bypassing the lower end turning part 21 ', then go around the upper end turning part 22 from the lower end close to the mould, in a counterclockwise direction;

(3) bypass the above-mentioned upper end turn-back portion 22 equally, and then go around to the lower end turn-back portion 22' by the same method as above,

(4) Take the head of another long metal wire of the same material, start the metal wire around the lower end turning part 23', and rotate 360 degrees clockwise with a slope of 60 degrees against the mould, According to the "S" shape, evenly go up and down to the corresponding upper end 23; after bypassing the upper end turning part 23, then go around in a counterclockwise direction from the lower end close to the mold and return to the lower end turning part 22'; and so on. , until the whole above-mentioned piercing mold is wound around, after removing the folded part 20, a net tubular cylindrical metal support can be formed. As shown in Figure 18.

The wire mesh in the occluder stent 1 provided by the embodiment of the present invention can pass the longitudinal wires and the horizontal wires through each other to form small diamond-shaped boxes. As shown in accompanying drawing 31, the longitudinal wires and the horizontal wires wherein each horizontal wire first passes through two longitudinal wires and then presses under the next two vertical wires, and each vertical wire first passes through two horizontal wires Then press it under the two horizontal wires next to it.

It can be seen that the above-mentioned mesh-shaped cylindrical support can be woven by two nickel-titanium metal wires back and forth without interruption. The two ends of the shaped metal support will finally retain two longer wire heads. As shown in Figure 18.

3. Fabrication of fixed structures at both ends of the occluder bracket

(1) Utilize the two sections of wire left on the disc surface 5a on the left atrium side of the mesh-shaped upper mouth of the above-mentioned mesh-shaped cylindrical metal stent, one end is from the clockwise direction, and the other end is wound along the mesh-shaped upper mouth with the other end in the counterclockwise direction. One and a half circles, the original intersecting mesh is used to go up and down, so that the two pieces of wire are just in the opposite position of the upper opening of the mesh, tighten the two pieces of wire, and the upper opening of the mesh forms a small circle 6a.

(2) Still use these two pieces of wire, according to the original weaving method of the mesh shape, weave overlappingly along the two wires in the center of the mesh shape to the lower opening of the above-mentioned mesh-shaped cylindrical metal bracket mesh, and use the same method as the upper opening , the lower mouth is also harvested into a small circle 8a.

(3) After the small circle 8a is harvested, use one of the threads to pass through the small circle 8a, go back and forth three times to form a loop, and use another thread to wind a rope-like loop on the loop until it is in the same shape as the loop. The other thread is crossed, and after several times of weaving and finishing, a connecting ring 3a is formed, and the diameter of the connecting ring 3a is 3mm.

Then heat it for heat treatment to preliminarily determine the network shape, so as to facilitate the processing of the subsequent process.

2. Production of occluder bracket shaping mold

According to the specifications of tubular stents with different lengths and diameters, select different specifications of shaping molds, place a device that can expand or shrink inside the mesh, or make a shaping mold of a certain shape by heating, and put it inside the stent , and put the bracket with the filling inside into the corresponding shaping mold for pressing, and fix it with a clamp. Then through heat treatment at different temperatures, products with shape memory characteristics and different specifications can be obtained.

3. Combination of occluder support and fibrous material

In the present invention, the braiding technology is applied to nickel-titanium alloy wires to weave a net tubular cylindrical bracket according to a certain route on the mould. temperature to achieve the required superelasticity and memory properties.

The stent 1 of the occluder is lined with a polyester film layer 2, and the polyester film 2 and the stent 1 are sewed together with medical sutures, put into a breathable sterilization bag and sterilized by ethylene oxide for use.

In clinical application, the size of the occluder is selected according to the diameter of atrial septal defect or ventricular septal defect measured by ultrasound, contrast and balloon. The size of the occluder usually selected is basically consistent with the balloon-measured atrial septal defect and the angiographically-measured ventricular septal defect. The occluder is delivered to the left atrium or left ventricle through the delivery device 30. In the left heart chamber, the left atrial disk is first opened, pulled back to the atrial and ventricular septal holes, and the right heart side disk is released. Under the guidance of ultrasound and X-ray, the implantation position and occlusion effect of the occluder were determined.

The wire mesh shown in the occluder stent provided by the present invention can be woven by a conventional method, wherein the longitudinal wires and the transverse wires pass through each other to form small diamond-shaped boxes. As shown in accompanying drawing 30, wherein the longitudinal wire and the horizontal wire pass through each other, and are pressed under each other every other time, and the longitudinal wire and the horizontal wire can be arranged at an angle of 30°. Also as shown in accompanying drawing 31, the longitudinal wires and the transverse wires therein pass through each other in different ways, wherein each horizontal wire first passes through two longitudinal wires and then is pressed under the next two longitudinal wires, the longitudinal wire and the transverse wire The filaments may be aligned at a 45° angle. Of course, the wires forming the wire mesh according to the invention may each consist of one filament, or several filaments, for example intertwined with each other.

Claims (11)

1, a kind of stopper that is used for congenital heart structural defect, constitute by metal fabric support and built-in obstruct blood flow fibrous matter, it is characterized in that described metal fabric support all forms a complete sealed construction by metal wire knitted by usefulness; Described support has the profile of default expansion; The shape of described stopper can inaccessible heart abnormality structure damaged, the shape variable shape of described default expansion is less section configuration, in order to carry by intravital blood vessel of patient and heart, described metal braid support has memory characteristic, make that described stopper can return to the profile of described default expansion when throwing the reins to.

2, stopper according to claim 1, it is characterized in that described stopper by super-elasticity and have the nitinol alloy wire support of shape memory function and the polyester fiber film that constrains in the described support combines, have the stressed characteristic of recovering default expansion profile after being pulled into linear and removing external force.

3, stopper according to claim 1 is characterized in that described stopper support mainly comprises a webmaster shape cylindrical stent waist, and is positioned at the left and right both ends of described support; Arbitrary end, the left and right sides all has left and right two sided circular flat, and the outside planar central of described left and right two sided circular flat has fixedly boundling point, and a described fixedly boundling point therein is connected with connecting ring.

4, stopper according to claim 3, the outer side plane that it is characterized in that the left and right two sided circular flat in described both ends constitutes by knitting skill, form smooth plane, around the planar central point of the left-external side of described left part by the inflection of the nitinol alloy wire of forming support around, and run through each inflection ring by the titanium-nickel wire annular of support self and make it connect into a complete integral body, and together with the gathering of inflection ring, form a tuftlet assembly place, around passing the inflection ring, form a firm fixing haptics repeatedly; The central point of the right outside disc of right part draws annular inflection ring together in by the nitinol alloy wire of support self, forms a tuftlet assembly place, repeatedly around passing the inflection ring, forms a firm fixing haptics.

5, stopper according to claim 4, the nickel-titanium metal silk that it is characterized in that described stopper support is through repeatedly by around fixing haptics making one connecting ring that is connected with fixing haptics on the right outer side plane of the left-external side plane of left part or right part.

6, a kind of method of making up of the support of stopper according to claim 1 is characterized in that this makes up method and comprise the following steps:

One, wears the making of net mould

(1) according to the requirement of the default profile of expanding, make the braiding mould, described braiding mould is processed into the metal cylinder shape earlier;

(2) go out some the five equilibrium grooves that a calibration is arranged in described metal cylinder Surface Machining;

(3) the fixing revers turn part of mesh grid of punching inside and outside groove between the both ends of described metal cylinder;

Two, the making of stopper support

(1) get an one metal wire the silk head, described tinsel is started from walking around the first upper end revers turn part (21) earlier, be close to the mould clockwise direction and revolve three-sixth turn, up and down equably around arriving and the corresponding first lower end revers turn part (21 ') of the first upper end revers turn part (21) with the gradient of 30-60 degree;

(2) after walking around the described first lower end revers turn part (21 '), rap around to the second upper end revers turn part (22) counterclockwise to be close to mould again from the lower end;

(3) walk around the above-mentioned second upper end revers turn part (22) equally, by with top same method again around to the second lower end revers turn part (22 '), so move in circles, up to around full whole above-mentioned wear the net mould till, after removing revers turn part, form a webmaster shape cylindrical metal support;

Above-mentioned webmaster shape cylindrical stent is uninterruptedly turned back back and forth to weave by certain angle by a nickel-titanium metal silk and is formed, the angle of the diameter of mould, the height of net form, net form is according to the ratio of predetermined stopper support, and the upper port of webmaster shape cylindrical metal support finally will keep two long one metal wire heads;

Three, the making of stopper support two ends fixed structure

(1) utilizes two sections silks staying above-mentioned webmaster shape cylindrical metal support net form upper port, the annular inflection ring of upper port is drawn in together,, tighten up this two sections silks, form a fixedly boundling null circle circle at the end suitable for reading of net form repeatedly around passing the inflection ring;

(2) still utilize this two sections silks, use the method identical, at the fixing boundling point ringlet of one at the end opening end of net form also harvest with braiding suitable for reading;

(3) repeatedly around passing the inflection ring, form a firm fixing haptics point respectively at the cylindrical both ends up and down of webmaster shape.

7, a kind of method of making up as stopper support as described in the claim 6 is characterized in that this makes up method and also comprise the following steps:

After the cylindrical up and down both ends of webmaster shape form a firm fixing haptics point respectively, the rhizoid wherein of harvest ringlet utilization in the end passes this ringlet, back and forth repeatedly, form a ring-type, utilize another rhizoid, on ring-type, twine out the ring of a rope form, until intersecting with another rhizoid, through repeatedly braiding arrangement, promptly form a connecting ring.

8, a kind of method of making up of stopper according to claim 1 is characterized in that this makes up method and comprise the following steps:

One, the making of stopper support

1, wears the making of net mould

(1) according to the requirement of the default profile of expanding, make the braiding mould, described braiding mould is processed into the metal cylinder shape earlier;

(2) go out some the five equilibrium grooves that a calibration is arranged in described metal cylinder Surface Machining;

(3) the fixing revers turn part of mesh grid of punching inside and outside groove between the both ends of described metal cylinder;

2, the making of stopper support

(1) get an one metal wire the silk head, described tinsel is started from walking around the first upper end revers turn part (21) earlier, be close to the mould clockwise direction and revolve three-sixth turn, up and down equably around arriving and the corresponding first lower end revers turn part (21 ') of the first upper end revers turn part (21) with the gradient of 30-60 degree;

(2) after walking around the described first lower end revers turn part (21 '), rap around to the second upper end revers turn part (22) counterclockwise to be close to mould again from the lower end;

(3) walk around the above-mentioned second upper end revers turn part (22) equally, by with top same method again around to the second lower end revers turn part (22 '), so move in circles, up to around full whole above-mentioned wear the net mould till, after removing revers turn part, form a webmaster shape cylindrical metal support;

Above-mentioned webmaster shape cylindrical stent is uninterruptedly turned back back and forth to weave by certain angle by a nickel-titanium metal silk and is formed, the angle of the diameter of mould, the height of net form, net form is according to the ratio of predetermined stopper support, and the upper port of webmaster shape cylindrical metal support finally will keep two long one metal wire heads;

3, the making of stopper support two ends retainer ring

(1) utilizes two sections silks staying above-mentioned webmaster shape cylindrical metal support net form upper port, the annular inflection ring of upper port is drawn in together,, tighten up this two sections silks, form a fixedly boundling null circle circle at the end suitable for reading of net form repeatedly around passing the inflection ring;

(2) still utilize this two sections silks, use the method identical, at the fixing boundling point ringlet of one at the end opening end of net form also harvest with braiding suitable for reading;

(3) repeatedly around passing the inflection ring, form a firm fixing haptics point respectively at the cylindrical both ends up and down of webmaster shape; In the end behind the harvest ringlet, utilize a rhizoid wherein to pass this ringlet, back and forth repeatedly, form a ring-type, utilize another rhizoid, on ring-type, twine out the ring of a rope form, until intersecting,, promptly form a connecting ring through repeatedly braiding arrangement with another rhizoid;

Two, the typing of stopper support

On mould, be woven into webmaster shape cylindrical stent by knitting skill being applied to nitinol alloy wire by certain route, after two ends are fixing, put between the special outer mold, after heat treatment form the double plate shape, and the control treatment temperature, reach the super-elasticity and the memory performance that need;

Choose the shaper of different size according to the specification of the tubular bracket of different length and diameter, place a kind of device that can enlarge or dwindle in netted inside, or make the shaper of definite shape by heating, put into internal stent, and have the support of charges to put into corresponding shaper inside to suppress, fix with anchor clamps, the heat treatment by different temperatures obtains having product shape memory characteristics, different size then;

The support liner of stopper is gone into the polyester rete, uses medical suture polyester film and support are stitched together, and it is standby to put into ventilative sterilization bag ethane via epoxyethane sterilization back.

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