Occlusive device for treating septal defect of congenital heart disease
Technical field
The invention belongs to technical field of medical instruments, specifically, relate to a kind of plugging device that is used for the treatment of patent ductus arteriosus and congenital heart diseases such as interventricular septum or atrial septal defect.
Background technology
Patent ductus arteriosus (PDA), atrial septal defect (ASD) and ventricular septal defect (VSD) are the common congenital heart diseases of children's, and the three accounts for 80% of whole congenital heart disease.Before the seventies, block up and close main dependence surgical operation; The mid-1970s, people begin to have designed and tried out the new non-breast of opening and close the method for ductus arteriosus and atrial septal defect and succeed, over more than 20 year, successively have the multiple stifled device that closes to try out in animal and clinical trial and obtained very big success, the stifled device that closes commonly used clinically at present both at home and abroad has five kinds of Portsman, Rashkind, Sideris, Coil and Amplatzer etc.Amplatzer Occluder is the up-to-date stifled device that closes of PDA, ASD, VSD, equaling design in 1997 by Amplatzer finishes, should stifled close the advantage that device has been concentrated former device, it expands into mushroom or double plate umbrella shape after being installed to the lesions position of heart automatically, this device is formed by superfine nitinol alloy wire braiding, the middle dacron of filling.Technically, mushroom or double plate umbrella shape stifled close device operate compare with other device easier, be subjected to clinician's welcome, but because tenor is excessive, and metal directly contacts with body, metal long-term toxic and side effects in vivo is difficult to determine, metal chronic injury and the mechanical irritation that causes easily blood vessel really up to the mark, thereby cause side effect such as long-term cardiac insufficiency, arrhythmia, so Amplatzer is stifled to be closed device and not to obtain the U.S. FDA identification always, do not generally acknowledged by the world that its application is very limited.
Summary of the invention
It is minimum that the problem to be solved in the present invention provides a kind of toxic and side effects, uses safer occlusive device for treating septal defect of congenital heart disease.
For addressing the above problem, occlusive device for treating septal defect of congenital heart disease of the present invention, comprise the mushroom or the double plate umbrella stull of being worked out by metal gauze, be filled with dacron in the support, the tinsel of support is coated with one deck degradable biocompatibility macromolecule material.
Owing to outside the tinsel of support, coated one deck degradable biocompatibility macromolecule material, the degradable biocompatibility macromolecule material is contacted with body tissue, avoided tinsel damage and the stimulation that causes really up to the mark to body, macromolecular material is isolated tinsel and tissue, thereby the toxicity of having isolated metal itself reduces even has stopped plugging device secular toxic and side effects in vivo fully.The existence of metal rack has guaranteed the mechanical strength of plugging device again.
As preference, the tinsel of above-mentioned support is preferably nitinol alloy wire, and its diameter is between 0.002~0.003 cun.Nitinol is a kind of shape memory alloy, has elastic performance, and the fatigue durability of Nitinol and corrosion resistance also are better than rustless steel.Adopting nitinol alloy wire is interior support, draws its diameter little and reduce the content of nitinol alloy wire in whole device as far as possible under the prerequisite that guarantees entire bracket intensity, to reduce the toxic and side effects of metal as much as possible.
As preference, above-mentioned degradable biocompatibility macromolecule material adopts existing polylactic acid or modified silica-gel or polyurethane through modification.By the modification of material, strengthen elasticity, the toughness of degradable biocompatibility macromolecule materials such as polylactic acid, silica gel or polyurethane and be controlled at intravital degradation time.
The present invention shows through animal experiment, compare with traditional occlusive device for treating septal defect of congenital heart disease, its metallic poison side effect reduces greatly, and is in the extreme little to the chronic injury and the mechanical irritation of blood vessel, a routine patient do not occur and cardiac insufficiency and ARR side effect occur.
Description of drawings
Below in conjunction with the drawings and specific embodiments the present invention is described in further detail.
Fig. 1 is the structural representation of the embodiment of the invention.
Fig. 2 is that the A of Fig. 1 is to view.
Fig. 3 is the schematic cross-sectional view (amplification) of nitinol alloy wire among Fig. 1.
The specific embodiment
Fig. 1 to Fig. 3 is that the present invention is used as the stifled embodiment that closes of ventricular septal defect (VSD), the support 1 of being worked out by the nickel-cemented alloy filament net of diameter between 0.002~0.003 cun is the double plate umbrella shape, be filled with dacron 2 in the support 1, the tinsel of support 1 is coated with one deck degradable biocompatibility macromolecule material 3, can directly to adopt publication number be CN1435438 to this degradable biocompatibility macromolecule material 3 among this embodiment, the modified polylactic acid material that was provided in the Chinese invention patent prospectus on August 13rd, 2003 in open day.Nitinol alloy wire is as interior support, its diameter is littler than the wire diameter of conventional apparatus, in the making under the prerequisite that guarantees entire bracket intensity, the diameter of nitinol alloy wire can draw smallerly as far as possible, nickel-cemented alloy filament net is also worked out rarelyr as far as possible, and to reduce the content of metal in whole device as much as possible, Nitinol is a kind of shape memory alloy, have elastic performance, the fatigue durability of Nitinol and corrosion resistance also are better than rustless steel.Degradable biocompatibility macromolecule materials such as polydactyl acid contact with body tissue, avoided tinsel damage and the stimulation that causes really up to the mark to body, the polymer modification polylactic acid is isolated tinsel and tissue, thereby the toxicity of having isolated metal itself reduces even has stopped plugging device secular toxic and side effects in vivo fully.By the modification of material, strengthened elasticity, the toughness of degradable biocompatibility macromolecule materials such as polylactic acid and be controlled at intravital degradation time.
Medium-height trestle 1 of the present invention also can be made into mushroom-shaped, as treatment patent ductus arteriosus type congenital heart disease.Also can be made into other shape as required.Degradable biocompatibility macromolecule material 3 can adopt modified silica-gel, also can adopt polyurethane, and the occlusive device for treating septal defect of congenital heart disease of producing can reach extraordinary effect equally.