CN2613248Y - Ventricular septel defect block device - Google Patents

Ventricular septel defect block device Download PDF

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Publication number
CN2613248Y
CN2613248Y CN 03229649 CN03229649U CN2613248Y CN 2613248 Y CN2613248 Y CN 2613248Y CN 03229649 CN03229649 CN 03229649 CN 03229649 U CN03229649 U CN 03229649U CN 2613248 Y CN2613248 Y CN 2613248Y
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CN
China
Prior art keywords
stopper
septal defect
disc
left ventricle
occlusion device
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CN 03229649
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Chinese (zh)
Inventor
秦永文
龚善石
许嘉龙
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Shanghai Shape Memory Alloy Material Co Ltd
Original Assignee
龚善石
秦永文
许嘉龙
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Priority to CN 03229649 priority Critical patent/CN2613248Y/en
Application granted granted Critical
Publication of CN2613248Y publication Critical patent/CN2613248Y/en
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Expired - Lifetime legal-status Critical Current

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Abstract

The utility model provides a heart separating defect occlusion device, which is a bracket (1) knitted by nitinol alloy wire, mainly comprising faced and standing left ventricular platters (2) of the occlusion device and the right ventricular platter (4) of the occlusion device, a waist portion (3) of the occlusion device which connects the left ventricular platter (2) of the occlusion device and the right ventricular platter (4), and a fixing connection part (5) positioned on one end of the occlusion device and connected with the right ventricular platter (4), wherein the fixing connection part (5) is provided with a connection hole passage (6) which can be connected with a transmission controlling system, the left ventricular platter (2) of the occlusion device and the right ventricular platter (4) of the occlusion device are symmetric structures, and the left ventricular platter (2) of the occlusion device in the utility model is a flat round disc. The utility model has stable structure and reasonable shape, and increases the safety of occluding the ventricular separating defect through a pipe.

Description

A kind of cardiac ventricular septal defect closer
Technical field
This utility model relates to the intraorganic medical apparatus and instruments of a kind of implant into body, is specifically related to a kind of cardiac ventricular septal defect closer.
Background technology
Congenital heart disease interventricular septal defect is a kind of common congenital heart disease, and the characteristics of pathological changes are that normally closed is failed in the ventricular septum between left and right ventricles.Because under the normal condition, the pressure of left ventricle is higher than right ventricle, cause that the blood part of left ventricle flow to right ventricle through interventricular septal defect punishment, the burden that causes the right side to feel concerned about system increases, cause right ventricular hypertrophy, pulmonary circulatory blood volume increases, and finally can cause pulmonary hypertension, arrhythmia and heart failure.Traditional therapy to interventricular septal defect was that surgical operation is sewed up in the past, and surgical operation need be opened breast, and was big to patient trauma, the complication rate height, and stay the operative incision cicatrix.In order to make congenital heart disease interventricular septal defect patient avoid open chest surgery, since 1976, successively invented multiple shutoff equipment both at home and abroad,, explored to use and send into the closed interventricular septal defect of stopper through cardiac catheter as the stopper of brands such as Rishkind, Sideris and Amplatzer.Find that through clinical practice the curative effect that Amplatzer stopper shutoff treatment pars muscularis chamber lacks is better, the complication rate that Rishkind, Sideris stopper treatment membranous part chamber lack is higher.But the stopper that does not have treatment membranous part compartment space compartment to lack on the market up to the present.
The type of ventricular septal heart defect is the important determiner of transcatheter therapy.The lesion characteristic of vessel occlusion of being suitable for passing through be interventricular septal defect at least apart from more than the aortic valve 3mm, the interventricular septal defect diameter is greater than 3mm with less than 10mm.Interventricular septal defect is not of uniform size, and form is also irregular, needs stopper that the model of different-diameter is arranged, to be fit to the interventricular septal defects of different sizes.Heart should be able to be fixed on the interventricular septal defect place beating of not stopping after stopper puts in place reliably.Can stopper be fixed reliably, and its determiner is to select the size of stopper and the elastic force of stopper support for use.Stopper elasticity is big, and resilient beam helps fixing, and is transported to the interventricular septal defect place but elastic strength is unfavorable for stopper greatly in conduit, also is unfavorable for withdrawing from when improper external as the big ting model selected.Therefore require the intensity of metal rack of stopper suitable.The stopper elastic strength depends primarily on the thickness of nitinol alloy wire and super elastic characteristics after heat treatment.Because the interventricular septal defect patient mostly is the child, blood vessel is thinner, and the delivery sheath that inserts endovascular importing stopper can not be greater than femoral venous diameter.Therefore, the selection of the thickness of titanium-nickel wire, super-elasticity and conduit diameter is one of basis principle of stopper design and making.Once more, the stopper surface should be smooth smooth, makes it to be difficult for to form thrombosis on its surface.Therefore the stopper surface should take into full account the close-coupled processing of surface in design.
Summary of the invention
The purpose of this utility model provides a kind of membranous ventricular septal defect stoppers that are suitable for different sizes of rational in infrastructure, surface smoothing.
For this reason, this utility model provides a kind of stopper through vessel occlusion interventricular septal defect.This stopper is symmetric double plate shape, and the stopper disc is mainly formed by the braiding of superelastic metal silk, sends into the position of heart defect through the heart conduit, in conduit, release the shape that the back is recovered design automatically, be clipped in damaged both sides, ventricular septum, make damaged closure, reach the purpose of healing.
The support of a kind of cardiac ventricular septal defect closer that this utility model provides for forming by the nitinol alloy wire braiding, it mainly comprises in opposite directions thirty years of age the left ventricle disc of stopper and the right ventricle disc of stopper, the waist of stopper that connects the right ventricle disc of the left ventricle disc of above-mentioned stopper and stopper, and be positioned at the fixed connecting part 5 that stopper one end links to each other with described right ventricle disc, on described fixed connecting part, there is the duct of connection to be connected with transport control system; Wherein, the left ventricle disc of described stopper and the right ventricle disc of stopper are symmetrical structure, and the left ventricle disc of described stopper is smooth disk.
During operation, stopper is connected with push rod by steel wire rope, draw in the short sheath, send in the long sheath pipe through short sheath, through delivery sheath stopper is pushed to the left ventricle place by push rod, the disc of left ventricle opens by the super-elasticity of self after going out the sheath pipe, and the place, scarce hole to the chamber pulls back, the left ventricle face of ultrasonic demonstration stopper is positioned at the left ventricle side, if any resistance, then fixing push rod is returned and is removed the sheath pipe, discharge the right ventricle disc, the disc of both sides is clipped in the both sides of ventricular septal defect by the super-elasticity of self, as pushing and stopper fixed-site when pulling back, then can discharge stopper, finish operation.
Because this utility model has been adopted the advantage of stopper in the past, adopt unique knitting skill to make the disk of left ventricle side, make it smooth, the left ventricle side panel sheet out-of-flatness of having avoided the present Amplatzer pars muscularis interventricular septal defect stopper of using clinically to use fixed screw to cause in the left ventricle side.All by nitinol alloy wire braiding, surface finishing helps stopper and implants epithelium posterius formation this utility model in the left ventricle side, reduce because of the left ventricle face not polishing may produce thrombotic complication.The marginal portion length inequality of the left ventricle disc of stopper, shorter at the edge of aortic valve side, and longer at the edge of apex of the heart side, can reduce the incidence rate of aortic regurgitation and increase stability.This utility model adopts a kind of novel fixture in the right ventricle side, adopts the kneading technology to make, and its pulling force is better than existing support by being welded at present greatly, and difficult drop-off; On described fixture, there is the duct of connection to be connected with transport control system, like this, make convenient for the control of stopper, flexibly, and, can make the fixture of stopper right ventricle side smaller and more exquisite, help epithelization to form after the implantation, reduce because of the right ventricle face not polishing may produce thrombotic complication.In addition, stopper is to form through special knitting skill braiding, can become linear behind the stressed tractive, can send into the interventricular septal defect place by the sheath pipe of 6~7F, and is all lighter to point of puncture and blood vessel injury.Promptly only need can finish the repairing operation of interventricular septal defect at appearance percutaneous incision skin 2~3mm.
Below, with embodiment this utility model is further described in conjunction with the accompanying drawings.
Description of drawings
The stopper left ventricle face structural representation that Fig. 1 provides for this utility model.
The perspective view of the stopper support that Fig. 2 provides for this utility model.
Fig. 3 is the local enlarged diagram of A portion among Fig. 2.
The stopper right ventricle face structural representation that Fig. 4 provides for this utility model.
Fig. 5 is the pulling-out force test pattern of existing stopper transmission link.
Fig. 6 is the pulling-out force test pattern of this utility model transmission coupling part.
The specific embodiment
Shown in accompanying drawing 1-4, the support 1 of a kind of cardiac ventricular septal defect closer that this utility model embodiment provides for forming by the nitinol alloy wire braiding, it mainly comprises in opposite directions thirty years of age the left ventricle disc 2 of stopper and the right ventricle disc 4 of stopper, the waist 3 of stopper that connects the right ventricle disc 4 of the left ventricle disc 2 of above-mentioned stopper and stopper, and be positioned at the fixed connecting part 5 that stopper one end links to each other with described right ventricle disc 4, on described fixed connecting part 5, there is the duct 6 of connection to be connected with transport control system; Wherein, the left ventricle disc 2 of described stopper and the right ventricle disc of stopper 4 are symmetrical structure, and the left ventricle disc 2 of described stopper is smooth disk.
This utility model is woven into flat bottom bags shape by certain route by a nitinol alloy wire on mould, one end is used the 316L stainless steel coil and is fixed, and puts between the special outer mold, after heat treatment forms symmetric double plate shape, and the control treatment temperature, reach the super-elasticity and the memory function that need.
The fixedly connected control assembly 5 of right ventricle side one end of a kind of stopper that this utility model provides is used the fixing control of medical stainless steel circle, the lateral ends of described stainless steel coil has the duct 6 of connection to be connected with transport control system, its inner hollow, can link to each other with above-mentioned nitinol alloy wire, should there be solder joint between described screw and the titanium-nickel wire, but adopting the kneading technology to make, its pulling force is better than existing support by being welded at present greatly, and difficult drop-off; As Fig. 5, shown in Figure 6, the control end of existing stopper adopts solder technology, when passing through maximum pulling-out force 60 Newtonian times, prolong 2.6 millimeters, and the stopper control end that this utility model provides when maximum pulling-out force be 200 Newtonian times, extend 1.2 millimeters, as seen, this utility model adopts the pulling-out force of no solder joint apparently higher than existing stopper with welding.
Support 1 liner of a kind of novel ventricular septal defect that this utility model provides is gone into 3-5 layer polyester film, uses medical suture polyester film and holder part are stitched together, and it is standby to put into special-purpose sterilization bag ethane via epoxyethane sterilization back.
During operation, the fixed connecting part of stopper is connected with push rod by steel wire rope, draw in the short sheath, send in the long sheath pipe through short sheath, through delivery sheath stopper is pushed to the left ventricle place by push rod, the disc of left ventricle opens by the super-elasticity of self after going out the sheath pipe, and the place, scarce hole to the chamber pulls back, the left ventricle face of ultrasonic demonstration stopper is positioned at the left ventricle side, if any resistance, then fixing push rod is returned and is removed the sheath pipe, discharge the right ventricle disc, the disc of both sides is clipped in the both sides of ventricular septal defect by the super-elasticity of self, as pushing and stopper fixed-site when pulling back, then can discharge stopper, finish operation.
This utility model ventricular septal defect is to be made of superelastic nickel titanium alloy wire, polyester fiber film and the part of fixedlying connected.Nitinol alloy wire is the stopper support; The polyester fiber film serves as a contrast into middle, plays the effect that stops blood flow; The effect of fixedly connected part is that fixedly the NiTi spun gold is connected with providing with transport control system.The profile of stopper is symmetric double plate shape, and the waist that connects two disks is slightly less than both sides, and is cylindrical, two side discs than the about 4mm of waist diameter about.The left ventricle side of stopper is smooth disk, and the right ventricle side has fixed steel ring.
During application, be connected with push rod by steel wire rope, an end of tractive steel wire rope is passed through in the back that puts in place, and both separate.Stopper has good shape memory function, is subjected to external force traction and is linear, and external force is recovered original-shape after removing immediately.
Clinical should in, the ventricular septal defect diameter of measuring according to radiography in the ultrasonic and art is selected the size of stopper, selects the big 1~2mm of diameter of stopper usually.Stopper is sent into left ventricle through delivery sheath, at first opens the waist of left ventricle face and stopper in left ventricle, returns and removes the sheath pipe, discharges the disc of right heart face.Under ultrasonic and the guiding of X-ray line, determine position and the plugging effect that stopper is implanted.
Embodiment 1.
The diameter 5mm of membranous ventricular septal defect, its edge is apart from more than the aortic valve 3mm.Select the ventricular septal defect of waist diameter 6mm for use.The left ventricle face sheet diameter of stopper is 10mm, and right ventricle face sheet diameter is 10mm.The stopper height is 2mm.
Embodiment 2.
The diameter 8mm of ventricular septal defect, its edge is apart from more than the aortic valve 4mm.Select the ventricular septal defect of waist diameter 10mm for use.The left ventricle face sheet diameter of stopper is 14mm, and right ventricle face sheet diameter is 14mm.Highly be 2mm.

Claims (5)

1, a kind of cardiac ventricular septal defect closer, it is characterized in that this stopper has the braiding of Memorability metal alloy wires by one and forms, mainly comprise: the support of superelastic nickel titanium alloy wire (1), lining is gone into support (1) the intermediary polyester fiber film barrier layer of above-mentioned stopper and the fixed connecting part (5) of support (1) one end that is fixed on above-mentioned stopper.
2, a kind of cardiac ventricular septal defect closer according to claim 1, it is characterized in that described stopper mainly comprises in opposite directions thirty years of age the left ventricle disc (2) of stopper and the right ventricle disc (4) of stopper, the waist (3) of stopper that connects the right ventricle disc (4) of the left ventricle disc (2) of above-mentioned stopper and stopper, and be positioned at the fixed connecting part (5) that stopper one end links to each other with described right ventricle disc (4), on described fixed connecting part (5), there is connection duct (6) to be connected with transport control system.
3,, a kind of cardiac ventricular septal defect closer according to claim 1 and 2, it is characterized in that the left ventricle disc (2) of described stopper and the right ventricle disc (4) of stopper are symmetrical structure, the left ventricle disc (2) of described stopper is smooth disk.
4, a kind of cardiac ventricular septal defect closer according to claim 1 and 2, it is characterized in that described fixed connecting part (5) adopts the fixing control of medical stainless steel circle, should not have solder joint between described fixed steelring and the titanium-nickel wire, adopt the kneading technology to make.
5, a kind of cardiac ventricular septal defect closer according to claim 1 and 2, the profile that it is characterized in that described stopper is symmetric double plate shape, the waist that connects two disks is slightly less than both sides, and is cylindrical, two side discs than the about 4mm of waist diameter about.
CN 03229649 2003-03-21 2003-03-21 Ventricular septel defect block device Expired - Lifetime CN2613248Y (en)

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Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100400012C (en) * 2004-08-19 2008-07-09 先健科技(深圳)有限公司 Biological ceramic stopper and method for manufacturing the same
JP2009529994A (en) * 2006-03-24 2009-08-27 オクルテク ゲーエムベーハー Occlusion device and manufacturing method thereof
WO2012034298A1 (en) * 2010-09-16 2012-03-22 先健科技深圳有限公司 Occlusion device and method for its manufacture
US8398670B2 (en) 2004-03-19 2013-03-19 Aga Medical Corporation Multi-layer braided structures for occluding vascular defects and for occluding fluid flow through portions of the vasculature of the body
CN103099652A (en) * 2013-02-19 2013-05-15 湖南埃普特医疗器械有限公司 Left auricle plugging device and transport system
CN103479422A (en) * 2013-10-05 2014-01-01 王学建 Defect repair device for neuroendoscope through nose
US8747453B2 (en) 2008-02-18 2014-06-10 Aga Medical Corporation Stent/stent graft for reinforcement of vascular abnormalities and associated method
US8777974B2 (en) 2004-03-19 2014-07-15 Aga Medical Corporation Multi-layer braided structures for occluding vascular defects
CN104042257A (en) * 2014-05-05 2014-09-17 尚小珂 Ventricular septal defect hole occluder
CN104173080A (en) * 2014-07-21 2014-12-03 上海形状记忆合金材料有限公司 Occlusion device
CN104224246A (en) * 2014-05-05 2014-12-24 尚小珂 ASD (atrial septal defect) reserved-hole occluder
US9039724B2 (en) 2004-03-19 2015-05-26 Aga Medical Corporation Device for occluding vascular defects
US9084589B2 (en) 2007-08-02 2015-07-21 Occlutech Holding Ag Method of producing a medical implantable device and medical implantable device
CN104173080B (en) * 2014-07-21 2017-01-04 上海形状记忆合金材料有限公司 A kind of plugging device
CN106725998A (en) * 2017-01-04 2017-05-31 泸州岷宏科技有限公司 A kind of dummy and its manufacture method
CN107080564A (en) * 2017-05-22 2017-08-22 王有然 Single riveting, self-adaptation type oval hole plugging device
US9763666B2 (en) 2013-02-19 2017-09-19 Apt Medical Inc. Left atrial appendage plugging device and delivery system

Cited By (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8398670B2 (en) 2004-03-19 2013-03-19 Aga Medical Corporation Multi-layer braided structures for occluding vascular defects and for occluding fluid flow through portions of the vasculature of the body
US9877710B2 (en) 2004-03-19 2018-01-30 St. Jude Medical, Cardiology Division, Inc. Multi-layer braided structures for occluding vascular defects and for occluding fluid flow through portions of the vasculature of the body
US9445798B2 (en) 2004-03-19 2016-09-20 St. Jude Medical, Cardiology Division, Inc. Multi-layer braided structures for occluding vascular defects
US9445799B2 (en) 2004-03-19 2016-09-20 St. Jude Medical, Cardiology Division, Inc. Multi-layer braided structures for occluding vascular defects
US9039724B2 (en) 2004-03-19 2015-05-26 Aga Medical Corporation Device for occluding vascular defects
US8777974B2 (en) 2004-03-19 2014-07-15 Aga Medical Corporation Multi-layer braided structures for occluding vascular defects
CN100400012C (en) * 2004-08-19 2008-07-09 先健科技(深圳)有限公司 Biological ceramic stopper and method for manufacturing the same
EP2389870A3 (en) * 2006-03-24 2012-09-12 Occlutech Holding AG Occlusion instrument and method for its production
US9532772B2 (en) 2006-03-24 2017-01-03 Occlutech Holding Ag Occlusion device and method for its manufacture
EP2422709B1 (en) 2006-03-24 2017-11-08 Occlutech Holding AG Occlusion instrument and method for its production
JP2009529994A (en) * 2006-03-24 2009-08-27 オクルテク ゲーエムベーハー Occlusion device and manufacturing method thereof
EP1998686B2 (en) 2006-03-24 2018-02-21 Occlutech Holding AG Occlusion instrument and method for its production
US11751858B2 (en) 2006-03-24 2023-09-12 Occlutech Gmbh Occlusion device and method for its manufacture
US10743852B2 (en) 2006-03-24 2020-08-18 Occlutech Holding Ag Occlusion device and method for its manufacture
EP2389872A3 (en) * 2006-03-24 2012-09-05 Occlutech Holding AG Occlusion instrument and method for its production
EP2266465A1 (en) * 2006-03-24 2010-12-29 Occlutech GmbH Occlusion instrument and method for its production
EP2422709A1 (en) * 2006-03-24 2012-02-29 Occlutech Holding AG Occlusion instrument and method for its production
US9084589B2 (en) 2007-08-02 2015-07-21 Occlutech Holding Ag Method of producing a medical implantable device and medical implantable device
US8747453B2 (en) 2008-02-18 2014-06-10 Aga Medical Corporation Stent/stent graft for reinforcement of vascular abnormalities and associated method
WO2012034298A1 (en) * 2010-09-16 2012-03-22 先健科技深圳有限公司 Occlusion device and method for its manufacture
CN103099652B (en) * 2013-02-19 2015-08-12 湖南埃普特医疗器械有限公司 A kind of left atrial appendage occlusion device and a kind of induction system
CN103099652A (en) * 2013-02-19 2013-05-15 湖南埃普特医疗器械有限公司 Left auricle plugging device and transport system
US9763666B2 (en) 2013-02-19 2017-09-19 Apt Medical Inc. Left atrial appendage plugging device and delivery system
CN103479422A (en) * 2013-10-05 2014-01-01 王学建 Defect repair device for neuroendoscope through nose
CN104224246A (en) * 2014-05-05 2014-12-24 尚小珂 ASD (atrial septal defect) reserved-hole occluder
CN104224246B (en) * 2014-05-05 2017-04-12 尚小珂 ASD (atrial septal defect) reserved-hole occluder
CN104042257A (en) * 2014-05-05 2014-09-17 尚小珂 Ventricular septal defect hole occluder
CN104173080B (en) * 2014-07-21 2017-01-04 上海形状记忆合金材料有限公司 A kind of plugging device
CN104173080A (en) * 2014-07-21 2014-12-03 上海形状记忆合金材料有限公司 Occlusion device
CN106725998A (en) * 2017-01-04 2017-05-31 泸州岷宏科技有限公司 A kind of dummy and its manufacture method
CN107080564A (en) * 2017-05-22 2017-08-22 王有然 Single riveting, self-adaptation type oval hole plugging device

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C41 Transfer of patent application or patent right or utility model
TR01 Transfer of patent right

Effective date of registration: 20090109

Address after: 199, Tongji Road, Shanghai, Baoshan District, China: 200940

Patentee after: Shanghai Marmem Material Co., Ltd.

Address before: No. 199 Tongji Road, Shanghai, 200940

Co-patentee before: Qin Yongwen

Patentee before: Gong Shan Shi

Co-patentee before: Xu Jialong

ASS Succession or assignment of patent right

Owner name: SHANGHAI FORM MEMORY ALLOY MATERIALS CO., LTD.

Free format text: FORMER OWNER: GONG SHANSHI

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Expiration termination date: 20130321

Granted publication date: 20040428