Swell-shrink closing stopper
Technical field
The present invention relates to technical field of medical instruments, relate in particular to a kind of swell-shrink closing stopper that uses in the blood vessel of damaged pathological changes such as heart arter patent ductus, atrial septal defect or ventricular septal defect that is used for the treatment of.
Background technology
When diseases such as treatment heart arter patent ductus, atrial septal defect or ventricular septal defect, early stage way is patient to be opened heart undergo surgery, and defect is blocked up close, and then sew and mend with needlework.This method need be carried out major operation, needs to carry out extracorporeal circulation in the operation process, and is quite complicated, dangerous property, and patient need be in hospital for a long time could rehabilitation, both just rehabilitation also can stay lifelong cicatrix at health.
Closing stopper is the medical apparatus and instruments that is used for the treatment of damaged pathological changes such as heart arter patent ductus, atrial septal defect or ventricular septal defect that grows up gradually, can adopt the guiding of metal wire or conduit to enter diseased region, thereby damaged diseased region is carried out shutoff by the intravital blood vessel of patient.
China national Department of Intellectual Property is CN98808876.2 in the patent No. of bulletin on October 11st, 2000, name is called the patent of invention of " obstruction appliance of pre-rider guiding ", a kind of collapsible medical apparatus and instruments is disclosed, comprise metal knitted product, it has the profile of default expansion, each near-end and far-end in this default profile of expanding comprise a groove, described each near-end and far-end have a device, it is used for inside grooves is fixed and be contained in each end that is attached on the metal knitted product, the inaccessible unusual opening of the shape energy of wherein said medical apparatus and instruments, therefore the shape variable shape of described default expansion is less section configuration, in order to carry by the intravital fluid flow tube of patient, these metal knitted product have memory characteristic, make when throwing the reins to medical apparatus and instruments often turn back to the profile of described default expansion.
The shape of this collapsible medical apparatus and instruments is determined by heat treatable metal knitted product.Metal knitted product are made of number of metal line thigh and heat-treat in mould so that the required form of fixed apparatus basically.Medical apparatus and instruments comprises bolt tool, and on a guiding metal wire or delivery conduit, wherein the formation of medical apparatus and instruments makes bolt tool be attached to an inside grooves that is formed in the medical apparatus and instruments.
The existing this closing stopper of being made by metal material is in stifled closed procedure, because the activity of heart, stifled closing can occur and locate seepage or the long-term pain with distension of cardiac muscle, symptoms such as interval human body folder decreases or myocardium inwall frays in atrial septal defect, ventricular septal defect blocking, can occur.Place in the human body owing to obstruction appliance in addition, and therefore the whole metal material that adopts of obstruction appliance needs patient to avoid the highfield throughout one's life, makes troubles to life always; Metal material is to adopt Nitinol, and nickeliferous metal object is kept somewhere in the body for a long time, and the patient has sense of discomfort, and nickeliferous metal material has certain toxicity, but sensitization and carcinogenic adopts nickel titanium alloy cost height in addition, and large tracts of land is promoted and is restricted.
Summary of the invention
Technical problem to be solved by this invention is: overcome existing closing stopper in stifled closed procedure, symptoms such as interval human body folder decreases or myocardium inwall frays can appear, and the whole metal material that adopts influences patient's life, shortcomings such as manufacturing cost height, a kind of swell-shrink closing stopper is provided, reduce the situation that the human body folder decreases or myocardium inwall frays at interval and occur, avoid being retained in the lifelong discomfort that the metal object in the heart is brought to the patient, and reduce cost.
The present invention solves the problems of the technologies described above the technical scheme that is adopted to be:
This swell-shrink closing stopper, comprise a utricule, described utricule is composited by macromolecule fabric and thermoplastic elastomer (TPE), utricule produces by liquid filling and expands, utricule is formed and the corresponding cryptomere profile of the unusual opening part shape of human body, and when throwing the reins to, being withdrawn into default profile, this default profile makes described utricule be transported to the unusual opening part of human body by the human body fluid flow tube via conveyer device.
Described swell-shrink closing stopper, wherein, described utricule can coat one deck macromolecule fabric outward by thermoplastic elastomer and form.
Described swell-shrink closing stopper, wherein, described macromolecule fabric can adopt terylene net or polyamine fat silk screen.
Described swell-shrink closing stopper, wherein, described utricule near-end can be respectively equipped with one with distal site and be connected clamp device, be respectively applied for two ends of sealing, fastening compound back utricule, and link and to make utricule can fill to form the shape that needs that described connection clamp device is contained in inside, utricule two ends after the utricule filling.
Described swell-shrink closing stopper, wherein, described connection clamp device can be respectively the socket of being located at utricule far-end and near-end, and the connecting rod that two ends can be connected with two sockets by screw thread respectively is set between two sockets, the near-end of described connecting rod also is connected with the conveying lever of described conveyer device; The near-end socket be through hole as the liquid filling mouth, far-end socket sealing, can be filled utricule during with the disengagement of near-end socket screw thread at described connecting rod; Under the drive of connecting rod, when being threaded, the liquid of filling in the utricule is sealed with described near-end socket at described conveying lever.
Described swell-shrink closing stopper, wherein, the described utricule that forms after liquid filling expands can be dumbbell shaped, comprise two expansion diameter parts and be positioned at two expansions recessed in the groove part of both sides diameter dimension in the middle of the diameters, the diameter of this groove part and width just embed unusual opening of atrial septal defect or the unusual opening part of ventricular septal defect.
Described swell-shrink closing stopper, wherein, the diameter of the side expansion diameter parts of the described utricule that forms after the full expansion of liquid can be greater than opposite side.
Described swell-shrink closing stopper, wherein, the described utricule that forms after liquid filling expands can be the bottle stopper shape, comprise the part of an expansion diameter and recessed, this recessed patent ductus arteriosus place that just embeds unusual opening in the diameter and the width of described expansion diameter parts in the part of described expansion diameter.
Described swell-shrink closing stopper, wherein, the described utricule that forms after liquid filling expands can be spherical or American football shape, and the diameter of this shape and length just embed in the artery and vein fistula of unusual opening.
Described swell-shrink closing stopper wherein, is used for liquid that described utricule is filled and adopts medical use liquid, or the polymeric hardener agent, and the described polymeric hardener agent shape that is in a liquid state when injecting is solidified as solid-stately then, makes described closing stopper fixed in shape.
Beneficial effect of the present invention is: from the manufacturing process aspect, existing manufacturing process equipment needed thereby all is advanced equipments of high grade and precision, meet sb. at the airport etc. as numerical control laser engraving machine, pulsed laser welder, plasma welding, the present invention only needs conventional equipment, can realize as automatic knitting machine, macromolecule compounding machine etc.Relatively, the traditional handicraft material therefor is the nickel-titanium metal silk from the material aspect, and material therefor of the present invention is the complex of macromolecule fabric and thermoplastic elastomer (TPE), and its price ratio is conspicuous.
From aspect of performance relatively, the closing stopper that traditional handicraft is made in stifled closed procedure, stifled place's seepage or the long-term pain with distension of cardiac muscle of closing can occur.Symptoms such as interval human body folder decreases or myocardium inwall frays appear in atrial septal defect, ventricular septal defect blocking.Maximum hidden danger is that the metal object that is retained in the heart can be brought lifelong discomfort to the patient.The closing stopper that the present invention makes is nonmetallic materials because of its material, and the situation of above-mentioned appearance can be avoided.
In sum, manufacturing process of the present invention is simple, and material is cheap, must cause cost to reduce, and the market sale price descends significantly, but the large tracts of land popularization, thus bring convenience to the patient; The present invention has reduced the situation that the human body folder decreases or myocardium inwall frays at interval simultaneously and has occurred, and can avoid being retained in the lifelong discomfort that the metal object in the heart is brought to the patient.
Description of drawings
Fig. 1 is a closing stopper exemplary plot one of the present invention;
Fig. 2 is a closing stopper exemplary plot two of the present invention;
Fig. 3 is a closing stopper exemplary plot three of the present invention.
The specific embodiment
With embodiment the present invention is described in further detail with reference to the accompanying drawings below:
As shown in Figure 1, the closing stopper that present embodiment is swell-shrink, comprise a utricule 50, utricule 50 is formed by thermoplastic elastomer 52 outer coating one deck macromolecule fabric 51 (can adopt terylene net or polyamine fat silk screen), utricule is filled to produce by liquid 70 and is expanded, utricule is formed and the corresponding cryptomere profile of the unusual opening part shape of human body, and when throwing the reins to, being withdrawn into default profile, this default profile makes described utricule be transported to the unusual opening part of human body by the human body fluid flow tube via conveyer device.
The closing stopper fabric will have certain elasticity and intensity.Elasticity makes it be easy to shrink conveyer device, emits back injection firming agent or medical use liquid and can expand into certain specification again; Intensity is to be difficult for breaking after certain external force effect being subjected to, and excellent biological compatibility will be arranged, and very fast formative tissue is compatible in human body, and is fit to human body.Thermoplastic elastomer (TPE) plays the effect of constraint sacculus shape, and for thermoplastic elastomer, by the mold molding, mold is shaped capsule and macromolecule fabric be compound again to be one, make capsule portion fill its required shape.
Utricule 50 near-ends can be respectively equipped with one with distal site and be connected clamp device, be respectively applied for two ends of sealing, fastening compound back utricule, and link and to make utricule can fill to form the shape that needs that described connection clamp device is contained in inside, utricule two ends after the utricule filling.Connecting clamp device can be made by the medical stainless steel material.
As shown in Figure 1, connect clamp device and be respectively the socket 58,55 of being located at utricule 50 far-ends and near-end, and the connecting rod 56 that two ends can be connected with two sockets by screw thread respectively is set between two sockets 58,55, the near-end of connecting rod 56 also is connected with the conveying lever 60 of described conveyer device by screw thread; Near-end socket 58 be through hole as the liquid filling mouth, far-end socket 55 sealing when connecting rod 56 is thrown off with near-end socket 58 screw threads, can be filled utricule 50; When connecting rod 56 under the drive of described conveying lever 60, when being threaded, the liquid 70 of filling in the utricule 50 are sealed with described near-end socket 58.
The utricule that forms after liquid filling expands among Fig. 1 can be dumbbell shaped, comprise two expansion diameter parts 501,502 and be positioned at two expansions recessed in the groove part 503 of both sides diameter dimension in the middle of the diameters, the diameter of this groove part 503 and width just embed unusual opening of atrial septal defect or the unusual opening part of ventricular septal defect.
The characteristics that closing stopper has automatic expansion, formalizes automatically are to increase making capacity, and the composite membrane in the closing stopper can the nature condensation.Because of left atrial pressure a little more than right atrium, so a side of the utricule that forms through the full back of expanding of liquid expand the diameter of diameter parts can be greater than opposite side.
Be used for liquid that utricule is filled and adopt medical use liquid, or the polymeric hardener agent, the polymeric hardener agent shape that is in a liquid state when injecting is solidified as solid-stately then, makes described closing stopper fixed in shape.
In use, closing stopper is preset in the conveyer device conduit, can implant unusual opening part by patient's thigh artery and vein, as after sending into the interatrial septum, inject medical use liquid by near-end socket 58 utricule is expanded, atrial septal defect is partly blocked up close, adopt the polymeric hardener agent as liquid, then liquid but can become solid-stately rapidly makes the closing stopper fixed in shape.Under the drive of conveyer device conveying lever 60, when connecting rod 56 is threaded with near-end socket 58, makes stifled the closing of endoporus of near-end socket 58, thereby the liquid 70 of filling in the utricule 50 is sealed.Again conveyer device is taken out, just can effectively block up and close the unusual opening of human body.
Conveyer device is made up of delivery sheath, collection device and conveying lever.Delivery sheath is similar to vascular puncture sheath pipe, selects the diameter (6F-14F) of delivery sheath according to the size of closing stopper.Also have the collection device and the conveying lever that use with the delivery sheath coupling, when closing stopper discharges, use.
Be illustrated in figure 2 as another embodiment of the present invention, its material is with to be connected clamp device all identical with embodiment one, different is that the utricule 80 that forms after liquid filling expands is the bottle stopper shape, comprise one the expansion diameter part 801 and one recessed in the expansion diameter part 802, this recessed patent ductus arteriosus place that just embeds unusual opening in the diameter and the width of described expansion diameter parts 802.
Be illustrated in figure 3 as another embodiment of the present invention, its material is with to be connected clamp device all identical with embodiment one, different is that the utricule 90 that forms after liquid filling expands is spherical or American football shape, and the diameter of this shape and length just embed in the artery and vein fistula of unusual opening.
The closing stopper that the present invention is swell-shrink, the lumen position that can be used for unusual opening is blocked up and is closed, wherein swell-shrink closing stopper, by the high polymer elastic complex through special PROCESS FOR TREATMENT molding.The high polymer elastic composite surface adheres to a kind of special and have the net of fabulous biocompatible materials braided expansile, contraction, through hot synthetic type.The present invention adopts the utricule of whole formation to come unusual position blocked up and closes, stifled close effective, and reduced the situation appearance that the human body folder decreases or myocardium inwall frays at interval, avoid being retained in the lifelong discomfort that the metal object in the heart is brought to the patient, and reduced cost.
Those skilled in the art do not break away from essence of the present invention and spirit, can there be the various deformation scheme to realize the present invention, the above only is the preferable feasible embodiment of the present invention, be not so limit to interest field of the present invention, the equivalence that all utilizations description of the present invention and accompanying drawing content are done changes, and all is contained within the interest field of the present invention.