CN1190176C - Ventricular septal defect blocking apparatus and its making method - Google Patents
Ventricular septal defect blocking apparatus and its making method Download PDFInfo
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- CN1190176C CN1190176C CNB021040303A CN02104030A CN1190176C CN 1190176 C CN1190176 C CN 1190176C CN B021040303 A CNB021040303 A CN B021040303A CN 02104030 A CN02104030 A CN 02104030A CN 1190176 C CN1190176 C CN 1190176C
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- plate rail
- septal defect
- ventricular septal
- webmaster
- blocking apparatus
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Abstract
The present invention relates to a ventricular septal defect blocking apparatus and a making method thereof. The monolayer tray frame is made into a monolayer butterfly-shaped tray frame, namely that parts of tray frame are respectively arranged at corresponding positions of trays to form the tray frames which are similar to wings of a butterfly; the rest parts do not have tray frames. Thus, the blocking apparatus is implanted in a human body; the parts without tray frames can not damage important adjacent texture structures such as aortic valves, etc. at the periphery of the septal defect; thus, the blocking apparatus of the present invention can be used for the ventricular septal defect of a muscular parts and ventricular septal defect of a velamen part. The making method of the blocking apparatus comprises the following steps that carving, cutting and stitching are treated on a ni titanium tube to form a net pipe which carries out vacuum heat treatment to form a super-elastic net pipe; an oxidation film on the surface is removed by surface treatment; the net pipe and a joint are welded and fixed; finally, the net pipe is filled in a mould, formed at high temperature and demoulded. The present invention can block various types of ventricular septal defects, and has good blocking effect. The present invention does not damage the peripheral texture structures, and the making method and operation are safe and convenient.
Description
Technical field
The present invention relates to a kind of medical apparatus and instruments and manufacture method thereof, be specifically related to a kind of shutoff device and manufacture method thereof of medical human ventricular septal heart defect.
Background technology
The traditional therapy of human heart ventricular septal defect is to carry out surgical operation, the interventional therapy of congenital heart disease has obtained developing rapidly in recent years, the clinical practice of patent ductus arteriosus closing stopper, atrial septal defect closing stopper occurred.Ventricular septal defect blocking apparatus only is applicable to the muscular ventricular septal defect that accounts for ventricular septal defect 1～5%.And accounting for the structures surrounding complexity of the membranous ventricular septal defect of ventricular septal defect 30～50%, contiguous aortic valve, Bicuspid valve, Tricuspid valve are its conductive beam, right ventricle in more than the muscle bundle etc.At present, the ventricular septal defect blocking apparatus of development can cause and close on above-mentioned tissue, particularly can cause aortic valve damage and produce severe complication such as aortic regurgitation, thereby the interventional therapy of membranous ventricular septal defect does not still have sophisticated closing stopper and can be applicable to clinical.
Summary of the invention
In order to overcome the damaged important adjacent tissue structure on every side of existing ventricular septal defect blocking apparatus easy damaged, be difficult to be applied to clinical deficiency, the invention provides a kind of ventricular septal defect blocking apparatus and manufacture method thereof, this ventricular septal defect blocking apparatus can block up and close polytype ventricular septal defect, have the good stifled effect of closing, the most important thing is this closing stopper can avoid damaging damaged around important adjacent tissue structure such as aortic valve; And its manufacturing and operate equal safe ready.
The technical solution adopted for the present invention to solve the technical problems is: a kind of ventricular septal defect blocking apparatus, comprise monolayer plate rail, cylinder, double-deck plate rail, union joint and bluff body, cylinder, monolayer plate rail and double-deck plate rail are tubular metal, the monolayer plate rail is monolayer " butterfly " shape plate rail, this plate rail has the part plate rail respectively at the relative position place of dish, form " butterfly " shape, monolayer " butterfly " shape plate rail and double-deck plate rail are connected with the cylinder two ends respectively, form netted asymmetric " worker " font, wherein the diameter of monolayer " butterfly " shape plate rail is greater than the diameter of double-deck plate rail; The other end and the union joint of double-deck plate rail join; In the inner chamber of monolayer " butterfly " shape plate rail, double-deck plate rail, cylinder pipe, the monoblock type bluff body is housed all; All be carved with plurality of rows and connect the joint-cutting of tube wall on the outer surface of the outer surface of cylinder pipe and double-deck plate rail, each row's joint-cutting is all discontinuous, is broken into plurality of sections; The joint-cutting of each section arrangement straggly between the adjacent row, the expansion back forms the metal webmaster with grid.
The making step of the manufacture method of ventricular septal defect blocking apparatus of the present invention is:
(1) laser engraving webmaster
Adopt the high-precision laser engraving technology, on selected NiTi pipe, carve out joint-cutting, make it to be shaped to the grid that expanded dimension requires, form webmaster;
(2) vacuum heat
Webmaster is carried out vacuum heat, make to form hyperelastic webmaster;
(3) surface treatment
Adopt chemical method to clean and handle, remove the oxide-film that the webmaster surface forms;
(4) welding
Union joint and webmaster welding is fixing;
(5) molding
According to the needs of interventricular septum closing stopper structure, design the mould identical with structure, the webmaster of molding is packed in the mould, finalize the design the cooling back demoulding and molding under the condition of high temperature in heat treatment process.
Owing to adopt technique scheme, the monolayer plate rail of ventricular septal defect blocking apparatus of the present invention is made monolayer " butterfly " shape plate rail, promptly not to make whole circle plate rail, but the part plate rail is arranged respectively at the relative position place of dish, form the wing of similar butterfly, remainder does not then have plate rail, like this with behind the ventricular septal defect blocking apparatus implant into body of the present invention, owing to this no plate rail part is arranged, then can not damage damaged important adjacent tissue structures such as aortic valve on every side.
The invention has the beneficial effects as follows: ventricular septal defect blocking apparatus of the present invention both can be used for muscular ventricular septal defect, also can be used for common membranous ventricular septal defect, can block up and close polytype ventricular septal defect, stifled close respond well.Thereby make interventional therapeutic technique can in the treatment of ventricular septal defect, obtain extensive clinical practice.
The manufacture method of ventricular septal defect blocking apparatus of the present invention adopts technology such as laser engraving webmaster, enables to make monolayer " butterfly " shape plate rail, and its manufacturing and operate equal safe ready.
Description of drawings
Fig. 1 is the structural representation of ventricular septal defect blocking apparatus of the present invention
Fig. 2 is that end view drawing is looked on the right side of Fig. 1
Fig. 3 is that end view drawing is looked on the left side of Fig. 1
Fig. 4 is the metal webmaster expanded view that the engraving among Fig. 1 forms
Fig. 5 a and Fig. 5 b are the processing technology route maps of ventricular septal defect blocking apparatus of the present invention
The specific embodiment
The planform of ventricular septal defect blocking apparatus is to design according to the form of ventricular septal defect and to the basic demand of closing stopper, common ventricular septal defect is shaped as circle, wall thickness often is 4～7 millimeters, important adjacent structures such as aortic valve and Bicuspid valve, Tricuspid valve, conductive beam are arranged around it, and the vestibule both sides have 30～90mmHg pressure reduction.The planform of ventricular septal defect blocking apparatus of the present invention is designed to netted asymmetric " worker " font in view of the above.Fig. 1, Fig. 2, Figure 3 shows that an embodiment of closing stopper of the present invention.This ventricular septal defect blocking apparatus comprises monolayer plate rail 1, double-deck plate rail 5, cylinder 2, union joint 3 and bluff body 4, and cylinder 2, monolayer plate rail 1 and double-deck plate rail 5 are tubular metal.Monolayer plate rail 1 is monolayer " butterfly " shape plate rail, and this plate rail has the part plate rail respectively at the relative position place of dish, forms " butterfly " shape.Monolayer " butterfly " shape plate rail and double-deck plate rail 5 are connected with the cylinder two ends respectively, form netted asymmetric " worker " font, and wherein the diameter of monolayer " butterfly " shape plate rail is greater than the diameter of double-deck plate rail 5; The other end and the union joint 3 of double-deck plate rail 5 join.In the inner chamber of monolayer " butterfly " shape plate rail, double-deck plate rail 5, cylinder pipe, the compressible monoblock type bluff body made from macromolecular material 4 is housed all, to strengthen hindering the effect of blood circulation.
See also shown in Figure 4ly, all be carved with the joint-cutting that plurality of rows connects tube wall on the outer surface of the outer surface of cylinder pipe and double-deck plate rail 5, each row's joint-cutting is all discontinuous, is broken into plurality of sections.Each segment length of each row's joint-cutting is identical in the present embodiment, and each intersegmental spacing is identical, and the spacing between adjacent row is identical, the joint-cutting of each section between adjacent row ordered arrangement straggly.Cylinder pipe and double-deck plate rail 5 are one, and the joint-cutting of being carved on its tube wall also is one.Cylinder 2 of the present invention, monolayer " butterfly " shape plate rail and double-deck plate rail 5 are formed the closing stopper supporting networks, are telescopic network structure, with the expansion that adapts to shape and the needs of compression.The design of monolayer " butterfly " shape plate rail is the construction features that adapts to chamber, ventricular septal defect left side face.Caliber expansion during use, do not have the metal of joint-cutting partly to be linked to be uniform network on the tube wall this moment, forms the metal webmaster.
Closing stopper of the present invention also can reverse an angle in the outer face of double-deck plate rail 5, so that the radian of reticulate pattern bending strengthens, makes it not easy fracture.
The step of the manufacture method of ventricular septal defect blocking apparatus of the present invention is:
(1) laser engraving webmaster
Select niti-shaped memorial alloy tubing for use, on the high precision numerical control laser engraving machine, carve out joint-cutting as shown in Figure 4, make it to be shaped to the grid that expanded dimension requires, form webmaster with high resiliency and shape memory function.Carve the shape size of grid and the thickness of twine, depend on the specification size of closing stopper, can reach the radial force of designing requirement to guarantee closing stopper, and can tolerate 400,000 times Stromeyer test.
(2) vacuum heat;
Above-mentioned webmaster is carried out vacuum heat in vacuum heat treatment furnace, make it to form hyperelastic webmaster, can satisfy under external force that webmaster can be retracted in the sheath pipe of 2～3 millimeters of diameters, can satisfy again release from the sheath pipe after, the webmaster diameter can be extended to the shape need about 10 times.
(3) surface treatment
Through laser engraving or heat treated webmaster, the surface has formed layer oxide film, in order to remove oxide-film fully, does not injure the fine-structure mesh silk again, adopts electrochemical method to clean and processing, removes the oxide-film that the webmaster surface forms.In surface treatment process, with the time of mechanical hand control webmaster processing.Webmaster after surface treatment is by the uniformity, the smoothness of computer microscopic analysis systems inspection grid.
(4) welding
Adopt this high-energy-density welding method of laser weld, titanium-nickel wire webmaster and the welding of medical stainless steel union joint is fixing.Because the input of the heat of laser weld is little, the deposite metal amount is few, and high-temperature residence time is short, helps obtaining high performance connector.After the welding, can guarantee the memory function of shape, have certain mechanical property again, can bear certain pulling force and the bigger operation fatigue intensity of tolerance.
(5) molding
Utilize the shape memory characteristic of nickel-titanium alloy material,, design the mould identical, the webmaster of molding is packed in the mould, finalize the design under the condition of high temperature in heat treatment process, the cooling back demoulding and molding with structure according to the structure needs of interventricular septum closing stopper.Supporting network after the requirement molding can recover design shape rapidly after stressed test.
The making route of ventricular septal defect blocking apparatus of the present invention as shown in Figure 5.
Among the figure: 1. IQC is the english abbreviation (Incoming Quality Control) of Incoming Quality Control
2. IPQC is the english abbreviation (In Processing QualityControl) of procedure inspection
3. add dash area in the block diagram and represent that this flow process carries out at ten thousand grades of dust proof workshops
The operating process of ventricular septal defect blocking apparatus of the present invention is as follows: ventricular septal defect blocking apparatus induction system form by carrying long sheath, delivery conduit, guiding to lack sheath.The external screw thread of delivery conduit one end links to each other with the female thread of the adapter of interventricular septum closing stopper, the other end of delivery conduit is contained in the short sheath of guiding, by guiding short sheath closing stopper is sent into the long sheath of conveying, carry long sheath closing stopper to be sent into heart by vein blood vessel, guide to the ventricular septal defect position, and block with closing stopper.Again delivery conduit is twisted in the other direction, the screw thread of conduit and closing stopper is unclamped and break away from,, finish treatment again with delivery conduit and carry long sheath to withdraw from human body.Closing stopper of the present invention is safe and effective, easy and simple to handle, easily reclaims.
Claims (7)
1, a kind of ventricular septal defect blocking apparatus, it is characterized in that: described ventricular septal defect blocking apparatus comprises monolayer plate rail, cylinder, double-deck plate rail, union joint and bluff body, cylinder, monolayer plate rail and double-deck plate rail are tubular metal, the monolayer plate rail is monolayer " butterfly " shape plate rail, this plate rail has the part plate rail respectively at the relative position place of dish, form " butterfly " shape, monolayer " butterfly " shape plate rail and double-deck plate rail are connected with the cylinder two ends respectively, form netted asymmetric " worker " font, wherein the diameter of monolayer " butterfly " shape plate rail is greater than the diameter of double-deck plate rail; The other end and the union joint of double-deck plate rail join; In the inner chamber of monolayer " butterfly " shape plate rail, double-deck plate rail, cylinder pipe, the monoblock type bluff body is housed all; All be carved with plurality of rows and connect the joint-cutting of tube wall on the outer surface of the outer surface of cylinder pipe and double-deck plate rail, each row's joint-cutting is all discontinuous, is broken into plurality of sections; The joint-cutting of each section arrangement straggly between the adjacent row, the expansion back forms the metal webmaster with grid.
2, ventricular septal defect blocking apparatus according to claim 1 is characterized in that: described cylinder pipe and double-deck plate rail are one, and the joint-cutting of being carved on its tube wall also is one.
3, ventricular septal defect blocking apparatus according to claim 1 and 2, it is characterized in that: each segment length of each row's joint-cutting of being carved on double-deck plate rail and cylinder tube outer surface is identical, each intersegmental spacing is identical, spacing between adjacent row is identical, the joint-cutting of each section ordered arrangement straggly between the adjacent row, the expansion back forms the metal webmaster with even network.
4, ventricular septal defect blocking apparatus according to claim 1 and 2 is characterized in that: reverse an angle in the outer face of described double-deck plate rail.
5, a kind of manufacture method of ventricular septal defect blocking apparatus according to claim 1 is characterized in that: the making step of this method is:
(1) laser engraving webmaster
Adopt the high-precision laser engraving technology, on selected NiTi pipe, carve out joint-cutting, make it to be shaped to the grid that expanded dimension requires, form webmaster;
(2) vacuum heat
Webmaster is carried out vacuum heat, make it to form hyperelastic webmaster;
(3) surface treatment
Adopt chemical method to clean and handle, remove the oxide-film that the webmaster surface forms;
(4) welding
Union joint and webmaster welding is fixing;
(5) molding
According to the needs of interventricular septum closing stopper structure, design the mould identical with structure, the webmaster of molding is packed in the mould, finalize the design the cooling back demoulding and molding under the condition of high temperature in heat treatment process.
6, the manufacture method of ventricular septal defect blocking apparatus according to claim 5 is characterized in that: the time of handling with mechanical hand control webmaster in surface treatment process; Webmaster after surface treatment is by the uniformity, the smoothness of computer microscopic analysis systems inspection grid.
7, the manufacture method of ventricular septal defect blocking apparatus according to claim 5 is characterized in that: adopt laser weld to weld titanium-nickel wire webmaster and rustless steel union joint fixing.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021040303A CN1190176C (en) | 2002-03-06 | 2002-03-06 | Ventricular septal defect blocking apparatus and its making method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB021040303A CN1190176C (en) | 2002-03-06 | 2002-03-06 | Ventricular septal defect blocking apparatus and its making method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1442122A CN1442122A (en) | 2003-09-17 |
| CN1190176C true CN1190176C (en) | 2005-02-23 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB021040303A Expired - Fee Related CN1190176C (en) | 2002-03-06 | 2002-03-06 | Ventricular septal defect blocking apparatus and its making method |
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| CN (1) | CN1190176C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20240165728A1 (en) * | 2022-11-22 | 2024-05-23 | Fca Us Llc | Extruded weld joint backing insert |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8366743B2 (en) | 2005-01-28 | 2013-02-05 | Lifetech Scientific (Shenzhen) Co., Ltd | Heart septal defect occlusion device |
| CN100389732C (en) * | 2005-01-28 | 2008-05-28 | 先健科技(深圳)有限公司 | Heart septal defect stopper with self regulating function |
| CN103284767A (en) * | 2012-03-05 | 2013-09-11 | 赵菁 | Lightweight atrium and ventricle coloboma occluder |
| CN103300896B (en) * | 2012-03-09 | 2015-07-22 | 郑州大学第一附属医院 | Bilateral single-layer umbrella type plugging device |
| CN103300895B (en) * | 2012-03-09 | 2015-07-22 | 郑州大学第一附属医院 | Single-layer knitted umbrella-shaped cardiac septum occluder |
-
2002
- 2002-03-06 CN CNB021040303A patent/CN1190176C/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20240165728A1 (en) * | 2022-11-22 | 2024-05-23 | Fca Us Llc | Extruded weld joint backing insert |
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| Publication number | Publication date |
|---|---|
| CN1442122A (en) | 2003-09-17 |
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