A kind of novel congenital heart disease atrial septal defect plugging device
Technical field
This utility model relates to technical field of medical instruments, is specifically related to a kind of novel congenital heart disease atrial septal defect plugging device.
Background technology
This utility model relates to technical field of medical instruments, is a kind of medical material that is used for the treatment of the congenital heart disease atrial septal defect.
The congenital heart disease atrial septal defect is a kind of common congenital heart disease, and lesion characteristic is that normally closed is failed in the interatrial septum between left atrium.Because the pressure of left atrium is higher than right atrium, under pressure, left atrium the blood part flow to right atrium through atrial septal defect punishment, the burden that causes the right side to feel concerned about system increases, cause right ventricular hypertrophy, pulmonary circulatory blood volume increases, and finally can cause pulmonary hypertension, arrhythmia and heart failure.Traditional Therapeutic Method to atrial septal defect was a surgical operation in the past.Surgical operation need be opened breast, and is big to patient trauma, the complication rate height, and stay the operative incision cicatrix at body surface.In order to make the congenital heart disease patients with atrial septal defect adopt the interventional method treatment of Wicresoft, since 1976, successively invented multiple shutoff equipment both at home and abroad, explored to use and send into the closed atrial septal defect of stopper, reached the curative effect identical with the surgery open chest surgery through the heart conduit.The complication that can avoid simultaneously transfusing blood and cause by blood transfusion and surgical operation.
Main apparatus through the vessel occlusion atrial septal defect is a kind of utensil that is used for closed atrial septal defect, is called stopper.Stopper is dual disc, and the stopper disc is mainly formed by the braiding of superelastic metal silk, sends into the position of heart defect through the heart conduit, in conduit, release the original shape that the back is recovered design automatically, be clipped in damaged both sides, interatrial septum, make damaged closure, reach the purpose of curing atrial septal defect.
The man medical apparatus corporation, Ltd of existing both at home and abroad number is at the development stopper, and the product of listing has CardioSEAL and Amplatzer stopper at present.The type of atrial septal defect is the important determiner of transcatheter therapy.The lesion characteristic of vessel occlusion of being suitable for passing through is that atrial septal defect has the above edge of 5mm at least, and damaged from coronary sinus, pulmonary vein and Bicuspid valve with more than the Tricuspid valve 5mm, the atrial septal defect diameter is greater than 5mm with less than 34mm.Atrial septal defect is not of uniform size, and form is also irregular, needs stopper that the model of different-diameter is arranged, to adapt to the atrial septal defects of different sizes.Heart should be able to be fixed on the atrial septal defect place beating of not stopping after stopper puts in place reliably.Can stopper be fixed reliably, and its determiner is the size of the stopper selected for use and the hardness of stopper support.Stopper hardness is big, and resilient beam helps fixing, and is transported to the atrial septal defect place but hardness is unfavorable for stopper greatly through conduit, also is unfavorable for withdrawing from when improper external as the big ting model selected.Therefore require the hardness of metal rack of stopper suitable.The hardness of stopper depends primarily on the thickness of nitinol alloy wire and super-elasticity after heat treatment and shape memory characteristic.Because patients with atrial septal defect mostly is the child, blood vessel is thinner, and inserting endovascular delivery sheath can not be greater than femoral venous diameter.Therefore, the selection of the thickness of titanium-nickel wire, super-elastic shape memory performance and conduit diameter is one of basis principle of stopper design and making.In addition, the stopper surface should be smooth smooth, makes it to be difficult for to form thrombosis on its surface.Therefore the stopper surface should take into full account the close-coupled processing of surface in design.
Summary of the invention
The purpose of this utility model provides a kind of rational in infrastructure, a kind of novel congenital heart disease atrial septal defect plugging device of being suitable for different big or small ostium secundum defects.
A kind of novel congenital heart disease atrial septal defect plugging device that this utility model provides is fixedlyed connected circle by nitinol alloy wire support, polyester fiber film and a rustless steel and is combined.
The profile of support described in the utility model is symmetric double-face circular disc shape, the disc of left atrium side is by special knitting skill, form smooth plane, planar center is the junction of the annular inflection of support braided wires, run through each annular inflection ring by the nitinol alloy wire of forming support self and make its connection in aggregates, do not have riveted joint on the surface of support.And described disc runs through each annular inflection ring by the nitinol alloy wire of forming support self in the center of disc makes its connection in aggregates.
Advantage of the present utility model and positive effect: because this utility model has been adopted the advantage of stopper in the past, adopt unique knitting skill to make the disc structure of left atrium side, make it smooth, and stronger support force is arranged; Avoided using clinically at present the left atrium side panel sheet out-of-flatness that Amplatzer stopper more widely uses fixed screw to cause in the left atrium side.All by nitinol alloy wire braiding, surface finishing helps stopper and implants epithelium posterius formation this utility model in the left atrium side, reduce because of the left atrium face not polishing may produce thrombotic complication.In addition, stopper is to form through special knitting skill braiding, can become linear behind the stressed tractive, can send into the atrial septal defect place by the sheath pipe of 6~12F, and is all lighter to point of puncture and blood vessel injury.Promptly only need about appearance percutaneous incision skin 3mm, can finish the shutoff treatment of atrial septal defect.
This utility model provides a kind of novel left atrium side panel sheet to be the congenital heart disease atrial septal defect plugging device of incorporate smooth disk.Stopper is combined by superelastic nickel titanium alloy wire, polyester and stainless steel coil, has the stressed characteristic of recovering double plate shape profile after being pulled into linear and removing external force.The disc of left atrium side of the present utility model is by special knitting skill, form smooth plane, inflection ring by the nitinol alloy wire of forming support around the planar central point centers on, and run through each inflection ring by the titanium-nickel wire annular of support self and make its connection in aggregates, surface at support does not have riveted joint, its sound construction, form is reasonable.Elasticity of the present utility model is suitable, and shape is recovered fully, and support force is strong, inserts conveniently, and the location is easy, and curative effect is reliable.
Below, describe details and working condition in conjunction with the accompanying drawings and embodiments in detail according to the concrete device that the utility model proposes.
Description of drawings
Fig. 1 provides the perspective view of stopper support for this utility model.
The stopper left atrium face structural representation that Fig. 2 provides for this utility model.
The stopper right atrium face structural representation that Fig. 3 provides for this utility model.
The specific embodiment
Shown in accompanying drawing 1-3, a kind of novel congenital heart disease atrial septal defect plugging device that this utility model embodiment provides is combined by the fixing connecting portion 3 that transmits of nitinol alloy wire support 1, polyester fiber film 2 and a rustless steel.
The atrial septal defect plugging device that this utility model provides is to be made of superelastic nickel titanium alloy wire support 1, polyester fiber film 2 and the fixing connecting portion 3 that transmits.Wherein, described nitinol alloy wire is a stopper support 1; Described polyester fiber film 2 linings are gone into the centre of stopper support 1, play the effect that stops blood flow; Described fixedly transmission connecting portion 3 is positioned at an end of stopper support 1, and effect is fixing described nitinol alloy wire and provides and the push rod transmission part.
The profile of the atrial septal defect plugging device support 1 that this utility model provides is the double-face circular disc shape, and the waist 4 that connects two disks is cylindrical, and disk is bigger than described waist 4 diameters.The left atrium side 5 of described stopper support 1 is for being smooth discoid, and right atrium side 7 has described fixedly transmission connecting portion 3 hold-down nuts.
As shown in Figure 2, the disc face 5 of the left atrium side described in a kind of novel congenital heart disease atrial septal defect plugging device that this utility model embodiment provides is by special knitting skill, form smooth plane, planar center is the junction 6 of the annular inflection of support braided wires, run through each annular inflection ring by the nitinol alloy wire of forming support self and make its connection in aggregates, do not have riveted joint on the surface of support.And described disc runs through each annular inflection ring by the nitinol alloy wire of forming support self in the center of disc makes it connect into whole stopper support 1.As shown in drawings, disc face 5 profiles of described left atrium side are as lotus shape in full bloom, and the disc face 5 of above-mentioned left atrium side has a nitinol alloy wire center joint 6, can strengthen this planar force structure greatly, its sound construction, form is reasonable, and stronger support force is arranged.Clockwise direction rotation push rod connects both during application, then is separated from each other when being rotated counterclockwise.The disc face 5 of the described left atrium side of stopper has good shape memory function, is linear when being subjected to the external force tractive, and external force is recovered original-shape after removing immediately.
As shown in Figure 3, the right atrium side 7 one end centers of a kind of stopper that this utility model provides have fixedly connected control assembly 3 to use the fixing control of medical stainless steel circle, described stainless steel coil can link to each other with above-mentioned nitinol alloy wire, can or adopt the kneading technology by solder technology between described screw and the titanium-nickel wire, the preferred kneading technology that adopts should not have solder joint, and adopting the kneading technology to make, its pulling force is better than existing support by being welded at present and difficult drop-off greatly.
A kind of novel congenital heart disease atrial septal defect plugging device that this utility model embodiment provides is woven into flat bottom bags shape by certain route by nitinol alloy wire on mould, one end is used stainless steel coil and is fixed, put between the special outer mold, after heat treatment be shaped, and the control treatment temperature, reach the super-elasticity and the memory function that need.
In clinical practice, select the size of stopper according to the atrial septal defect diameter of sacculus measurement in ultrasonic and the art.Usually the stopper size of selecting is consistent with the atrial septal defect that sacculus is measured basically.Stopper is fed through left atrium through delivery sheath, at first opens the waist of left atrium face and stopper in left atrium, pulls back to lack in the hole to the room, returns and removes the sheath pipe, discharges the disc of right atrium face.Under guiding, ultrasonic and X line determine the implantation position and the plugging effect of stopper.
Embodiment 1.
Ostium secundum defect diameter 15mm, its centroid roof, edge portion, Bicuspid valve, Tricuspid valve, more than the pulmonary vein opening 5mm, select the atrial septal defect plugging device of waist diameter 15mm for use, the left atrium face sheet diameter of stopper is 29mm, the disc diameter 26mm of right atrium face.
Embodiment 2.
Ostium secundum defect diameter 34mm, its centroid roof, edge portion, Bicuspid valve, Tricuspid valve, more than the pulmonary vein opening 5mm, select the atrial septal defect plugging device of waist diameter 36mm for use, the left atrium face sheet diameter of stopper is 50mm, the disc diameter 48mm of right atrium face.