Bilateral single-layer umbrella type stopper
Technical field
The present invention relates to a kind of medical occluder, particularly a kind of bilateral single-layer umbrella type stopper, it is mainly used in repairing congenital atrium, interventricular septal defect in intervene operation.
Background technology
Congenital heart disease atrial septal defect and ventricular septal defect are all common congenital heart disease, and the feature of its pathological changes of heart atrial septal defect is that normally closed is failed at interval between left atrium, and blood flows between left atrium and right atrium; The feature of its pathological changes of ventricular septal defect is that normally closed is failed at interval between 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.Due to the leakage of blood, the burden causing the right side to feel concerned about system increases, and causes right ventricular hypertrophy, pulmonary hypertension, arrhythmia and heart failure.Just need when heart septal defect causes blood leakage more to repair septal defect place.Surgical operation is the traditional method for the treatment of heart septal defect, and its shortcoming needs to open breast, wound greatly to patient, and complication rate is high, recovery is slow.
Since the eighties in last century, Wicresoft's interventional therapy progressively becomes the first-selection for the treatment of heart septal defect, and at present, existing multiple cardiac ventricular septal defect closer is used to treatment Congenital Heart ventricular septal defect.The main part profile of stopper is butterfly, and it is one has memory preset profiles and can become the metallic elastic net for strip when being subject to force-extension, and after external force is removed, elastic network(s) can recover its preset profiles.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 eel-like figure two ends, and be provided with the diaphragm seal that one deck intercepts blood flow in each disk, elastic network(s) two ends are also welded with two joints.
Its using method, for ventricular septal defect, it opens an osculum at femoral vein place, insert wire to set up through the track of femoral vein to cardiac septum position, delivery sheath is inserted through track, then the stopper being connected with conveying wirerope is pushed delivery sheath and deliver to left room together, under the supervision of X-ray and color ultrasound, slowly stopper is opened after determining defect, first we open left dish, then pull back and carry wirerope and delivery sheath, side ring surface and left locular wall in left dish are fitted, after determining that laminating is good, slowly open the waist of stopper again, determine to open right card again after waist and defect relative position are well, make the left side of spaced walls by stopper originally having defect, right two cards are clamped, defect is closed, reach the object of clinical cure.
At present, the problem due to stopper self structure makes the volume of stopper all larger and weight is also large, loads in heart and takes up space also greatly, have impact on the normal operation of heart body.On the other hand, the position of tinsel bending forming elastic network(s) is also more, like this when performing the operation and Post operation just easily there is stopper metal reticulate pattern fracture damage patient's body tissue and be partially formed the situation of thrombosis.So we should reduce deflection and the distortion position of tinsel when designing stopper as far as possible, simplifying the structure of stopper as far as possible, making its volume less, thus reach good Long term therapy effect.
Summary of the invention
The object of the invention is to the defect and the deficiency that make up prior art, a kind of bilateral single-layer umbrella type stopper is provided, it can form stopper with less metallic elastic net, and decrease the position of tinsel overbending, make the structure of stopper more simple exquisite, reduce postoperative long term risk.
For achieving the above object, the technical solution used in the present invention is as follows: a kind of bilateral single-layer umbrella type stopper, comprise elastic network(s) and diaphragm seal, described elastic network(s) be by Nitinol rod be processed into there is elastomeric butterfly net, 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, left and right of thin waist respectively connected the left umbrella of a bell mouth shape be made up of reticulate pattern and right umbrella, left umbrella and right umbrella is monolayer net and edge-smoothing is smooth, the diameter of left umbrella and right umbrella is all greater than 3 ~ 10 millimeters, thin waist; Left umbrella and right umbrella are all vertical with thin waist, and the connection of left umbrella and right umbrella and thin waist is arc surface and is excessively connected; An axial screw for the seal wire that spins is provided with in one end of thin waist; Left umbrella and right umbrella lateral surface are separately sewed with the diaphragm seal that one deck intercepts blood flow, described diaphragm seal is the one in polyester film, poly tetrafluoroethylene, polyethylene film, make diaphragm seal on left umbrella and the right umbrella edge's flange wrapped the edge of left umbrella and right umbrella to the inside at left umbrella and right umbrella, make this smooth of the edge 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 its place in the catheter, when stopper is released from conduit, stopper can recover original butterfly immediately.
The procedure of processing of described elastic network(s) is: from Nitinol rod two ends to central bore, but can not drill through, the length of a thin waist is reserved in centre, Nitinol rod is processed into the obstructed pipe in a centre, the screw of an axis is processed at an end face of thin waist, the endoporus of reconditioning pipe and cylindrical make surfaces externally and internally smooth, on tube wall, staggered reticulate pattern is carved with laser engraving machine, with mouth stretching die, the mouth of pipe at two ends is strutted, process the left umbrella to the bell mouth shape turned up and right umbrella, through chemical attack deburring, through shape setting heat treatments, diaphragm seal made by 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%, reduce the untoward reaction at a specified future date after shutoff implant into body, there is no pad in this stopper simultaneously, avoid the risk of wire netting weld sealing-off, because left umbrella and right umbrella are the Open architecture turned up to monolayer, therefore decrease the hot pressing bending operation of wire netting, reduce the risk of wire netting fracture, improve operation Long-Term Safety equally, that also reduces the space that stopper occupies in human body, reduce the risk that stopper is encroached on perienchyma.Because diaphragm seal makes the outside covering left umbrella and right umbrella, make to make more accurate, simple, firm.
Accompanying drawing explanation
Fig. 1 is front view of the present invention.
Fig. 2 is right view of the present invention shown in Fig. 1.
Fig. 3 is the profile in Fig. 2.
Fig. 4 is the profile closing the pipe that rod is processed into NiTi.
Fig. 5 is schematic diagram stopper drawn in by seal wire in conduit.
Schematic diagram when Fig. 6 is stopper implantation interventricular septal defect position and has opened left umbrella.
Fig. 7 is the schematic diagram that stopper implants when the left umbrella in interventricular septal defect position and right umbrella are all opened.
In 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.
Detailed description of the invention
In figure, a kind of bilateral single-layer umbrella type stopper, comprise elastic network(s) 1, diaphragm seal 5, 6, described elastic network(s) 1 is holed through two ends by Nitinol rod, processing screw hole 7, reconditioning inside and outside circle, laser engraving, to rise a mouthful molding, heat treatment there is 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, left and right of thin waist 2 respectively connected left umbrella 3 and the right umbrella 4 of a bell mouth shape be made up of reticulate pattern, left umbrella 3 and right umbrella 4 is monolayer net and edge-smoothing is smooth, the diameter of left umbrella 3 and right umbrella 4 is all greater than 3 ~ 10 millimeters, thin waist, left umbrella 3 and right umbrella 4 are all vertical with thin waist 2, and left umbrella 3 is arc surface with right umbrella 4 with the connection of thin waist 2 and is excessively connected, an axial screw 7 for the seal wire 8 that spins is processed with in one end of thin waist 2, left umbrella 3 and the respective lateral surface of right umbrella 4 are sewed with one deck diaphragm seal 5,6 respectively, described diaphragm seal 5 or 6 is the one in polyester film, poly tetrafluoroethylene, polyethylene film, make diaphragm seal 5,6 on left umbrella 3 and the right umbrella 4 edge's flange wrapped the edge of left umbrella 3 and right umbrella 4 to the inside at left umbrella 3 and right umbrella 4, make the smooth of the edge of left umbrella 3 and right umbrella 4 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 be screwed in screw 7 that it is drawn in conduit 9, when stopper is released from conduit 9, stopper can recover original butterfly immediately.