A kind of small-sized implantation instrument with hangnailTechnical field
The present invention relates to a kind of intervention operation implantation instrument more particularly to a kind of small-sized implantation instruments with hangnail, useIn interventional therapy or prevention cardiovascular disease, belong to the field of medical instrument technology.
Background technique
In the variation of inside of human body tissue or defect, needs to be implanted into small-sized implantation instrument, need to be fixed in useInside of human body, such as occluder for left auricle.The position of left auricle of heart is special, and shape and structure varies with each individual, left atrial appendage surface lightSliding, the non-degradable occluder for left auricle listed at present is designed with special metal barb to fix occluder for left auricle.Even if in this way, still there is part occluder for left auricle to fall off because being not fixed firmly, or piercing through the left heart because hangnail is excessively sharpEar, on the contrary heart blood oozes out, pericardial tamponade, serious threat to life.
The Metal Substrate plugging device listed at present is much all unable to recycling since sharp hangnail designs upon discharge, orPerson is difficult recycling, and (recycling means that occluder for left auricle is severely deformed, cannot be used continuously, it is necessary to replace, while the head of sheathEnd is scratched by hangnail, cannot be used continuously, it is necessary to replace).In fact, ultrasound or contrast agent development can only see the plan view of 2DPicture, selecting less than normal or partially large-sized plugging device is common occurrence feelings in the course of surgery.
The vena cava filter listed at present uses barbed metal structure, to increase the fixation of vena cava filter moreDegree.But clinically also there is filter hangnail to puncture vena cave, lead to the clinical risks such as infection, bleeding.
Fish-bone line is a kind of operation suture thread with hangnail, as shown in Fig. 1 a- Fig. 1 f comprising absorbable and nonabsorableTwo kinds, clinical application is predominantly sewed up a wound or is organized in surgical operation.
Since fish-bone line surface is arranged in sequence with the hangnail of macroscopic tiny protrusion, in operation stitching, once byIt sutures into tissue, since numerous tiny hangnail penetrates tissue, so that suture must firmly be pricked into tissue, and cannotIt slips, therefore last operative doctor does not need to knot to suture, the breach of tissue can also be stitched together by suture, not have to loadHeart cracking.
Summary of the invention
The technical problem to be solved by the present invention is solving the bracket for how avoiding plugging device or other implantation inside of human bodyFall off and metal barb pierce through inside of human body tissue the problem of.
In order to solve the above-mentioned technical problem, the technical solution of the present invention is to provide a kind of small-sized implanting device with hangnailTool, which is characterized in that the small appliance ontology including being implanted into inside of human body connects with inside of human body tissue on small appliance ontologyIt touches and the position fixed is sewed with fish bone well suture, fish bone well suture is equipped with hangnail.
Preferably, the fish bone well suture is fish bone well absorbable suture；The material of fish bone well absorbable sutureMatter is PDO or PLA or PLLA or PDLA or PLGA or PCL；Small appliance ontology is woven by fish bone well absorbable sutureMolding is formed by common smooth absorbable suture and fish bone well absorbable suture mixed weaving.
Preferably, the small appliance ontology is Wholly-degradable occluder for left auricle or degradable plugging device or can dropSolve vena cava filter.
Preferably, the degradable plugging device be degradable atrial septal defect plugging device or ventricular septal defect orPatend ductus arteriosus occluder or vascular plug plugging device or oval hole plugging device.
Preferably, the fish bone well suture is the non-absorbable suture of fish bone well；The non-absorbable suture of fish bone wellSuture applied to bioprosthetic valves；The non-absorbable suture of fish bone well is sewn on the surface of valve bracket, and valve bracket is set to valveOn instrument.
Preferably, the material of the non-absorbable suture of the fish bone well is PA nylon or PP；Bioprosthetic valves are aorta petalOr pulmonary valve or tricuspid valve or bicuspid valve；Valve bracket is to expand formula bracket from Peng's formula bracket or ball；Small appliance ontology is by fishThe non-absorbable suture of bone type carries out knitting forming or by common smooth non-absorbable suture and the non-absorbable seam of fish bone wellThe molding of zygonema mixed weaving.
Preferably, the fish bone well suture is spacer structure, adjacent two sections on fish bone well suture, wherein one sectionBe it is smooth, another section is fish bone well, and the surface of one section of fish bone well suture Smooth is without hangnail, fish on fish bone well sutureThere is hangnail on the surface that one section of bone type.
Preferably, 5cm~30cm is divided between one section and barbed one section of fish bone well of the smooth no hangnail.
Preferably, the small appliance ontology is degradable film-coated vascular bracket or the nondegradable overlay film of Metal SubstrateThe biliary tract of bracket or overlay film, esophageal stents；The hangnail on fish bone well suture surface is uniformly distributed on suture surface；Hangnail is stitchingThe distribution mode on zygonema surface is that bilateral symmetry is distributed or rotates formula distribution straggly.
Preferably, all hangnails are equidirectional setting, and the angle between hangnail and suture length direction is 0~30 °.
The present invention is sewed with fish bone well suture on the small appliance ontology of original implantation inside of human body or directly by fishBone type suture is woven into small appliance ontology or by fish bone well suture and common smooth suture shuffling at small applianceOntology, since the hangnail on fish bone well suture (absorbable and non-absorbable) surface is very fine and smooth and soft, not with metal barbTogether, it is the position for making instrument be firmly fixed to defect or need to place by the mating reaction of more anchor points, therefore, can be withAvoid puncturing clinical risk caused by inside of human body tissue because of hangnail.And since fish bone well barb structure is tiny, it is evenly distributed,The recyclability of plugging device is had little influence on, even if being connect after plugging device discharges completely as long as not turned off between driving means,Can completely be recycled, and do not influence plugging device and sheath same perform the operation continue to use.The fish bone well of plugging device canThe degradation of absorbable suture line and matching for endothelialization rate.
Detailed description of the invention
Fig. 1 a is the main view (one) of fish bone well suture；
Fig. 1 b is the main view (two) of fish bone well suture；
Fig. 1 c is the main view (three) of fish bone well suture；
Fig. 1 d is the main view (four) of fish bone well suture；
Fig. 1 e is the sectional top view (one) of fish bone well suture；
Fig. 1 f is the sectional top view (two) of fish bone well suture；
Fig. 2 possible structural schematic diagram of a Wholly-degradable occluder for left auricle (one)；
Fig. 2 possible structural schematic diagram of b Wholly-degradable occluder for left auricle (two)；
Fig. 3 a be cabinet-type structure fish bone well suture schematic diagram (smooth section it is identical as the length of fish bone well section andEvery small)；
Fig. 3 b be cabinet-type structure fish bone well suture schematic diagram (smooth section it is identical as the length of fish bone well section andEvery big)；
Fig. 3 c is schematic diagram (length of the length of smooth section less than fish bone well section of the fish bone well suture of cabinet-type structureDegree)；
Fig. 3 d is schematic diagram (length of the length of smooth section greater than fish bone well section of the fish bone well suture of cabinet-type structureDegree).
Specific embodiment
In order to make the present invention more obvious and understandable, hereby with preferred embodiment, and attached drawing is cooperated to be described in detail below.
The present invention is a kind of small-sized implantation instrument with hangnail comprising it is implanted into the small appliance ontology of inside of human body, it is smallThe position for being in contact and fixing with inside of human body tissue in type instrument body is sewed with fish bone well suture, sets on fish bone well sutureThere is hangnail.The barb length of fish bone well suture is (0.2~1) mm.Fish bone well suture can be divided into the absorbable suture of fish bone wellTwo kinds of line and the non-absorbable suture of fish bone well.
The material of fish bone well absorbable suture can be polydioxanone (PDO), polylactic acid series (PLA,PLLA, PDLA, PLGA), polycaprolactone (PCL) etc..
The hangnail on the fish bone well absorbable suture surface is uniformly distributed on suture surface, can be bilateral symmetry pointCloth is also possible to rotate formula distribution straggly, as shown in Fig. 1 a- Fig. 1 f.
By using the small-sized implantation instrument of the invention with hangnail, the small-sized implantation instrument with hangnail is with left atrial appendage occlusionFor device: since the hangnail on fish bone well suture (absorbable and non-absorbable) surface is very fine and smooth and soft, with metal barbDifference, it is so that instrument is firmly fixed to defect by the mating reaction of more anchor points or the position placed is needed therefore to keep awayClinical risk caused by left auricle of heart wall is exempted to puncture because of hangnail.
Wholly-degradable occluder for left auricle can be formed using the absorbable suture braiding with fish bone well hangnail.
The absorbable suture of these braiding plugging devices can be entirely the absorbable suture with fish bone well hangnail,It can be common smooth absorbable suture and the absorbable suture mixed weaving with fish bone well hangnail；It is also possible to commonSmooth absorbable suture braiding is customized to the shape and structure of occluder for left auricle, then plugging device key position (with a left sideThe point that auricle inner wall is in contact) a few circle fish bone well absorbable sutures in suture.By means of fish bone well absorbable suture hangnailEffect, Wholly-degradable plugging device can be firmly fixed to the inner cavity of left auricle of heart, it is not easily shifted.
The matching of degradation and endothelialization rate:
The main material of the Wholly-degradable occluder for left auricle with hangnail: braided wires are polydioxanone(PDO), the material of the smooth absorbable suture of fish bone well absorbable suture and surface is PDO；Choked flow film is polylactic acid(PLA)；Both materials belong to bio-absorbable medical compound high molecular material, the medical device product made using these materialsThe U.S. Jun Yihuo PDA approval listing.
The choked flow film of the plugging device can be sewn to the inside of plugging device bracket, can also by way of electrostatic spinning packetIt overlays on the outer wall of plugging device.
After usual plugging device implantation human body, 1 month starts endothelialization, and endothelialization is basically completed within 3 months, 6 months endotheliumsChange intact.Material used in Wholly-degradable occluder for left auricle, polydioxanone (PDO) start degradation (6 for 6 monthsPlugging device morphosis is complete in a month), it degrades within 12 months obvious (morphosis has significant change), degrades in 3 years complete.It is poly-Lactic acid (PLA) starts to degrade for 12 months, degrades in 5 years complete.Both materials start to drop after the completion of plugging device endothelializationSolution, degradation cycle are fully completed in 5 years, and degradation rate matches with endothelialization rate.
Recyclability:
It since fish bone well barb structure is tiny, is evenly distributed, has little influence on the recyclability of plugging device, even if plugging deviceCompletely after release, it connect, can be completely recycled, and do not influence plugging device and sheath as long as not turned off between driving meansThat performs the operation at same continues to use.
The shape and structure of the occluder for left auricle can be multiplicity, can be with boston, U.S.A scientific companyThe LAmbre of Watchman, the ACP of Amplatzer company, the U.S. and domestic Xian Jian companyTMMain body framework structure is identical,It can be the design etc. on Fig. 2 a, Fig. 2 b, but do not need the special hangnail design in these plugging device surfaces.
The fish bone well absorbable suture can be also used for degradable plugging device, including degradable echocardiography in atrial septal defectDevice, ventricular septal defect, patend ductus arteriosus occluder, vascular plug plugging device, oval hole plugging device, to increase itFixed effect.
The fish bone well absorbable suture can be also used for degradable vena cava filter, to increase its fixation in the blood vesselsFirmness is prevented from shifting and be tilted.In actual clinical, the displacement and inclination of filter are high-incidence show.
Its use form can weave plugging device by fish bone well absorbable suture merely, be also possible to slickness and fish-boneType shuffling is also possible to specific position (point being in contact with tissue) suture on the surface of the degradable plugging device of smooth typeFish bone well absorbable suture.
The material of the non-absorbable suture of fish bone well is mainly polyamide (PA nylon), cotton synthetic fibre (PP) etc.；Fish bone well is non-canAbsorbable suture line can be applied to the suture of the bioprosthetic valves such as aorta petal, pulmonary valve, tricuspid valve, bicuspid valve, and fish bone well is non-to be inhaledOn the surface for receiving the valve bracket that suture is sewn in valve instrument, valve can both be sutured by reaching, while exposed in valve bracketThe hangnail of the suture on surface can increase the fixed effect of valve instrument, increase the firmness of its fixation.Valve bracket can be withIt is to be also possible to ball from Peng's formula and expand formula.
Hangnail on fish bone well suture can only be merely protrusion, may also require that all thorns will be equidirectional, angle is 0~30 °, and optimum range is 5~20 °.
Small appliance ontology by the non-absorbable suture of fish bone well carries out knitting forming or by common smooth non-absorbableSuture and the non-absorbable suture mixed weaving of fish bone well form.It can also be woven by common smooth non-absorbable sutureIt is customized to suture upper several circles in the position that small appliance ontology is in contact and fixes with inside of human body tissue after small appliance ontologyThe non-absorbable suture of fish bone well.
Fish bone well suture is also possible to cabinet-type structure, as shown in Fig. 3 a- Fig. 3 d, adjacent two on fish bone well sutureSection, wherein one section be it is smooth, another section is fish bone well, and the surface of one section of fish bone well suture Smooth is without hangnail, fish-boneThere is hangnail on one section of fish bone well of surface on type suture.According to the needs of actual use, one section and fish bone well of smooth no hangnailBarbed one section of interval specifically can be 5cm~30cm etc., and two kinds of surfaces put in order be also possible to it is a variety of.?The length of thorn is (0.2~1) mm.
Degradable film-coated vascular bracket (vein, artery), the nondegradable overlay film frame of Metal Substrate (vein, artery)Fish bone well suture (absorbable or non-absorbable), biliary tract, esophageal stents of overlay film etc. can be used.