Bilateral single layer umbrella formula stopper
Technical field
The present invention relates to a kind of medical stopper, particularly a kind of bilateral single layer umbrella formula stopper, it is mainly used in repairing in the intervene operation congenital atrium, interventricular septal defect.
Background technology
Congenital heart disease atrial septal defect and ventricular septal defect all are common Congenital Heart diseases, and the characteristics of its pathological changes of heart atrial septal defect are that normally closed is failed at the interval between the left atrium, and blood flows between left atrium and right atrium; The characteristics of its pathological changes of ventricular septal defect are that normally closed is failed at the interval between the left and right ventricles, and blood is flowed between left ventricle and right ventricle.Because the pressure of left atrium is higher than right atrium, so the part blood of left atrium flows to right atrium through atrial septal defect punishment.Because the leakage of blood, the burden that causes the right side to feel concerned about system increases, and causes right ventricular hypertrophy, pulmonary hypertension, arrhythmia and heart failure.When causing blood leakage more, the heart septal defect just need to repair the septal defect place.Surgical operation be the treatment heart septal defect traditional method, its shortcoming be need to open breast to patient, wound is large, complication rate is high, recovery is slow.
Wicresoft's interventional therapy progressively becomes the first-selection for the treatment of heart septal defect since the eighties in last century, and at present, existing multiple cardiac ventricular septal defect closer is used to treat the Congenital Heart ventricular septal defect.The main part profile of stopper is butterfly, and it is one has the default profile of memory and can become metallic elastic net for strip when being subject to force-extension, and elastic network(s) can recover its default profile after external force is removed.Be cylindrical eel-like figure in the middle of the elastic network(s) of formation stopper, respectively there is a double-layer hollow disk at the eel-like figure two ends, are provided with the diaphragm seal that one deck intercepts blood flow in each disk, and the elastic network(s) two ends also are welded with two joints.
Its using method, take ventricular septal defect as example, it is to open an osculum at the femoral vein place, inserting wire sets up through the track of femoral vein to the cardiac septum position, insert delivery sheath through track, the stopper that then will be connected with the conveying wirerope pushes delivery sheath and delivers to together left chamber, under the supervision of X-ray and color ultrasound, determine slowly to open stopper after the defect, we at first open left dish, then pull back and carry wirerope and delivery sheath, make side ring surface and the applying of left locular wall in the left dish, after determining to fit well, slowly open the waist of stopper again, determine to open right card after waist and defect relative position are well again, making originally has damaged spaced walls by the left side of stopper, right two cards are clamped, make damaged closure, reach the purpose of clinical cure.
At present, because the problem of stopper self structure takes up space in the heart of packing into also large so that the volume of stopper is all larger and weight is also large, affected the normal operation of heart body.On the other hand, the position of the tinsel bending of formation elastic network(s) is also more, just stopper metal reticulate pattern fracture damage patient's body tissue and local thrombosed situation occurs easily when operation and after the operation like this.So we should reduce deflection and the deformation place of tinsel when the design stopper as far as possible, simplify the structure of stopper as far as possible, make its volume less, thereby reach good therapeutic effect at a specified future date.
Summary of the invention
The object of the invention is to remedy defective and the deficiency of prior art, a kind of bilateral single layer umbrella formula stopper is provided, it can consist of stopper with less metallic elastic net, and the position of having reduced the tinsel overbending, so that the structure of stopper is more simple exquisite, reduced postoperative risk at a specified future date.
For achieving the above object, the technical solution used in the present invention is as follows: a kind of bilateral single layer umbrella formula stopper, comprise elastic network(s) and diaphragm seal, described elastic network(s) is to have an elastomeric butterfly net by what the Nitinol rod was processed into, large centre, elastic network(s) two is little, the middle part of elastic network(s) is the thin waist of a solid cylindrical, the two ends, the left and right sides of thin waist are connecting respectively left umbrella and the right umbrella of a bell mouth shape that is made of reticulate pattern, left umbrella and right umbrella be the monolayer net and edge-smoothing smooth, the diameter of left umbrella and right umbrella is all greater than 3~10 millimeters in thin waist; Left umbrella is all vertical with thin waist with right umbrella, left umbrella be connected umbrella and be arc surface with being connected of thin waist and excessively connect; End at thin waist is provided with one for the axial screw of the seal wire that spins; Be sewed with the diaphragm seal that one deck intercepts blood flow at left umbrella and right umbrella lateral surface separately, described diaphragm seal is a kind of in polyester film, poly tetrafluoroethylene, the polyethylene film, make diaphragm seal on left umbrella and right umbrella at the edge of left umbrella and right umbrella flange and wrapped the edge of left umbrella and right umbrella to the inside, so that this smooth of the edge is smooth.This stopper has good shape memory function, after left umbrella and right umbrella are packed up this stopper it can be deformed into strip, people can be placed on it in the conduit, when stopper was released from conduit, stopper can the original butterfly of immediate recovery.
The procedure of processing of described elastic network(s) is: hole to the centre from Nitinol rod two ends, but can not drill through, reserve the length of a thin waist in the centre, the Nitinol rod is processed into a pipe that the centre is obstructed, an end face at thin waist processes an axial screw, the endoporus of reconditioning pipe and cylindrical make surfaces externally and internally smooth, carve staggered reticulate pattern with laser engraving machine at tube wall, mouthful mould struts the mouth of pipe at two ends with rising, process left umbrella and right umbrella to the bell mouth shape that turns up, through the chemical attack deburring, formalize through heat treatment, make diaphragm seal at left umbrella and right umbrella two lateral surface, terminal disinfection packs.
The present invention compared with prior art beneficial effect is: the weight saving of stopper 50%, reduced the untoward reaction at a specified future date behind the shutoff implant into body, there is not pad in this stopper simultaneously, avoided the risk of wire netting weld sealing-off, because left umbrella and right umbrella are the Open architecture that turns up to monolayer, therefore reduced the hot pressing bending operation of wire netting, reduced the risk of wire netting fracture, improved equally the operation Long-Term Safety, it has also reduced the space that stopper occupies in human body, reduced the risk of stopper to perienchyma's infringement.Because diaphragm seal is made the outside that covers left umbrella and right umbrella, so that make more precisely, simply, firmly.
Description of drawings
Fig. 1 is front view of the present invention.
Fig. 2 is right view of the present invention shown in Figure 1.
Fig. 3 is the profile among Fig. 2.
Fig. 4 is for closing the profile of the pipe that rod is processed into NiTi.
Fig. 5 is for being drawn in schematic diagram in the conduit to stopper by seal wire.
Schematic diagram when Fig. 6 is stopper implantation interventricular septal defect position and opened left umbrella.
Fig. 7 is the schematic diagram of stopper when implanting the left umbrella in interventricular septal defect position and right umbrella and all opening.
Among the figure, 1. elastic network(s), 2. thin waist, 3. left umbrella, 4. right umbrella, 5,6. diaphragm seal, 7. screw, 8. seal wire, 9. conduit.
The specific embodiment
Among the figure, a kind of bilateral single layer umbrella formula stopper, comprise elastic network(s) 1, diaphragm seal 5,6, described elastic network(s) 1 is to be holed through two ends by the Nitinol rod, processing screw hole 7, the reconditioning inside and outside circle, laser engraving, mouthful molding of rising, heat treatment forms has elastomeric butterfly net, large centre, elastic network(s) 1 two is little, the middle part of elastic network(s) 1 is a cylindrical thin waist 2, the two ends, the left and right sides of thin waist 2 are connecting respectively left umbrella 3 and the right umbrella 4 of a bell mouth shape that is made of reticulate pattern, left umbrella 3 and right umbrella 4 be the monolayer net and edge-smoothing smooth, the diameter of left umbrella 3 and right umbrella 4 is all greater than 3~10 millimeters in thin waist; Left umbrella 3 and right umbrella 4 are all vertical with thin waist 2, left umbrella 3 be connected umbrella 4 and be arc surface with being connected of thin waist 2 and excessively connect; End at thin waist 2 is processed with one for the axial screw 7 of the seal wire 8 that spins; On left umbrella 3 and right umbrella 4 lateral surface separately, be sewed with respectively one deck diaphragm seal 5,6, described diaphragm seal 5 or 6 is a kind of in polyester film, poly tetrafluoroethylene, the polyethylene film, make diaphragm seal 5 on left umbrella 3 and right umbrella 4,6 at the edge of left umbrella 3 and right umbrella 4 flange and wrapped the edge of left umbrella 3 and right umbrella 4 to the inside, so that the smooth of the edge of left umbrella 3 and right umbrella 4 is smooth.This stopper has good shape memory function, after left umbrella 3 and right umbrella 4 are packed up this stopper it can be deformed into strip, at this moment people can utilize the seal wire 8 that is screwed in the screw 7 that it is drawn in the conduit 9, when stopper was released from conduit 9, stopper can the original butterfly of immediate recovery.