CN2610872Y - Asymmetric ventricular septal defect plugging device - Google Patents

Asymmetric ventricular septal defect plugging device Download PDF

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Publication number
CN2610872Y
CN2610872Y CN 03229648 CN03229648U CN2610872Y CN 2610872 Y CN2610872 Y CN 2610872Y CN 03229648 CN03229648 CN 03229648 CN 03229648 U CN03229648 U CN 03229648U CN 2610872 Y CN2610872 Y CN 2610872Y
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CN
China
Prior art keywords
stopper
disc
left ventricle
septal defect
right ventricle
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Expired - Lifetime
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CN 03229648
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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 03229648 priority Critical patent/CN2610872Y/en
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Publication of CN2610872Y publication Critical patent/CN2610872Y/en
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Abstract

The utility model relates to an asymmetric ventricular septal defect blocker, the bracket (1) of which is waved out of nitinol alloy wire. The utility model includes essentially of a left ventricle disk of the blocker (2) and a right ventricle disk of the blocker (4) which stand opposite to each other, and a blocker waist (3) through which the left ventricle disk of the blocker (2) and the right ventricle disk of the blocker (4) are connected, wherein one end of the left ventricle disk of the blocker (2) is connected with a fixedly connecting means (7), and the other end of the blocker is provided with the right ventricle disk (4) which is connected to a fixedly connecting means (5), the fixedly connecting means (5) is provided with a connecting drill way (6) connected with a convey control system, and the left ventricle disk of the blocker (2) and the right ventricle disk of the blocker (4) form an asymmetric structure. The utility model has a proper elasticity, is convenient to be put in and easy to position, and has a reliable healing effect.

Description

A kind of asymmetric interventricular septal defect stopper
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 asymmetric interventricular septal defect stopper.
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 as yet up to the present.
The type of interventricular septal 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 2mm, 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
Purpose of the present utility model provides a kind of rational in infrastructure, stopper of being suitable for the membranous part interventricular septal defect of different sizes.
For this reason, this utility model provides a kind of stopper through vessel occlusion interventricular septal defect.This stopper is asymmetrical dual disc, 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 asymmetric interventricular septal defect stopper 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 above-mentioned left ventricle disc and stopper, left ventricle disc one end of described stopper links to each other with fixed connecting part, the described stopper other end has described right ventricle disc to link to each other with fixed connecting part, has the duct of connection to be connected with transport control system on described fixed connecting part; Wherein, the right ventricle disc of the left ventricle disc of described stopper and stopper is a unsymmetric structure.
Advantage of the present utility model and positive effect: because this utility model has been adopted the advantage of stopper in the past, according to the form of ventricular septal defect and on every side structure, be made into irregular discoid, edge in the aortic valve side is shorter, can avoid stopper to insert the damage of back to aortic valve.This utility model is shorter in the length of the stainless steel coil of left and right ventricles side, helps the formation that stopper is implanted epithelium posteriusization, may produce thrombotic complication thereby reduce.On described fixture, there is the duct of connection to be connected, like this, makes convenient for the control of stopper, flexible with transport control system.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.
Specific embodiments
Shown in accompanying drawing 1-3, the support 1 of a kind of asymmetric interventricular septal defect stopper 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 above-mentioned left ventricle disc 2 and stopper, left ventricle disc 2 one ends of described stopper link to each other with fixed connecting part 7, the described stopper other end has described right ventricle disc 4 to link to each other with fixed connecting part 5, has the duct 6 of connection to be connected with transport control system on described fixed connecting part 5; Wherein, the right ventricle disc 4 of the left ventricle disc 2 of described stopper and stopper is a unsymmetric structure.
This utility model is woven into flat bottom bags shape by certain route by nitinol alloy wire on mould, two ends are used the 316L stainless steel coil and are fixed, and put between the special outer mold, after heat treatment form asymmetrical 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 disc 4 one ends of a kind of stopper that this utility model provides is all used the fixing control of medical stainless steel circle with the fixed connecting part 7 of left ventricle disc 2 one ends, the lateral ends of described stainless steel coil 5 has the duct 6 of connection to be connected with transport control system, the fixedly connected control assembly 5 of above-mentioned right ventricle one end and all inner hollow of fixed connecting part 7 of left ventricle disc 2 one ends, 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 adopt 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.
The support liner of a kind of asymmetric interventricular septal defect stopper that this utility model provides is gone into 3-10 layer polyester film, uses medical suture polyester film and holder part are stitched together, and it is standby to put into suction paper sterilization bag ethane via epoxyethane sterilization back.
During operation, stopper is connected with push rod, 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 interventricular septal defect by the super-elasticity of self, as pushing and stopper fixed-site when pulling back, then can discharge stopper, finish operation.
The nitinol alloy wire that this utility model provides 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 described stopper is asymmetrical double plate shape, the waist that connects two disks is cylindrical, disk is bigger than waist diameter, the disc of left ventricle side equates with column part at the aortic valve lateral edges, its offside is than the big 6mm of column part, the disc edge of right ventricle side is than the big 4mm of body diameter, for corresponding type distributes.The right ventricle side direction has fixed stainless steel coil.To be connected with transport portion in the side opening of steel wire penetrating stopper during application, an end of tractive steel wire rope discharged stopper after stopper put in place.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.
In clinical practice, select the size of stopper according to the interventricular septal defect diameter of radiography measurement in ultrasonic and the art.Usually select the about 1~2mm of diameter of stopper.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 part interventricular septal defect, its edge is apart from aortic valve 2mm.Select the interventricular septal defect stopper of waist diameter 6mm for use.The left ventricle face sheet diameter of stopper is 12mm, and the disc edge of close aorta side is 0.5mm, and right ventricle face sheet diameter is 10mm, and apex of the heart side panel sheet edge is 5.5mm.The stopper height is 2mm.
Embodiment 2
The diameter 8mm of interventricular septal defect, its edge is apart from more than the aortic valve 2mm.Select the interventricular septal defect stopper of waist diameter 10mm for use.The left ventricle face sheet diameter of stopper is 16mm, and the disc edge of close aorta side is 0.5mm, and right ventricle face sheet diameter is 14mm, and apex of the heart side panel sheet edge is 5.5mm.The stopper height is 2mm.

Claims (3)

1, a kind of asymmetric ventricular septal defect, it is characterized in that the support (1) that this stopper is formed by the nitinol alloy wire braiding, mainly comprise 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 above-mentioned left ventricle disc (2) and stopper, left ventricle disc (2) one ends of described stopper link to each other with fixed connecting part (7), the described stopper other end has described right ventricle disc (4) to link to each other with fixed connecting part (5), has connection duct (6) to be connected with transport control system on described fixed connecting part (5); Wherein, the right ventricle disc (4) of the left ventricle disc (2) of described stopper and stopper is a unsymmetric structure.
2, a kind of asymmetric ventricular septal defect according to claim 1, it is characterized in that described fixed connecting part (5), fixed connecting part (7) all adopt the fixing control of medical stainless steel circle, do not have solder joint between screw and the titanium-nickel wire, adopt the kneading technology to make.
3, a kind of asymmetric ventricular septal defect according to claim 1, the profile that it is characterized in that described stopper is asymmetrical double plate shape, the waist (3) that connects two disks is cylindrical, disk is bigger than waist diameter, the disc of left ventricle side (2) equates with column part at the aortic valve lateral edges, its offside is than the big 6mm of column part, and the disc of right ventricle side (4) edge is than the big 4mm of body diameter, for corresponding type distributes.
CN 03229648 2003-03-21 2003-03-21 Asymmetric ventricular septal defect plugging device Expired - Lifetime CN2610872Y (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101172048B (en) * 2007-09-07 2011-05-18 邢泉生 Transthoracic minimally invasive heart ventricular septal defect plugging device conveying system
CN101431946B (en) * 2006-04-27 2012-10-03 沃克拉心血管有限公司 Occluder
CN102895046A (en) * 2012-09-17 2013-01-30 邢泉生 Plugging device for a subconal or double-artery-valve subarterial ventricular septal defect
CN104159524A (en) * 2011-08-12 2014-11-19 W.L.戈尔及同仁股份有限公司 Heart occlusion devices

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101431946B (en) * 2006-04-27 2012-10-03 沃克拉心血管有限公司 Occluder
CN101172048B (en) * 2007-09-07 2011-05-18 邢泉生 Transthoracic minimally invasive heart ventricular septal defect plugging device conveying system
CN104159524A (en) * 2011-08-12 2014-11-19 W.L.戈尔及同仁股份有限公司 Heart occlusion devices
CN102895046A (en) * 2012-09-17 2013-01-30 邢泉生 Plugging device for a subconal or double-artery-valve subarterial ventricular septal defect
CN102895046B (en) * 2012-09-17 2016-04-06 邢泉生 A kind of dry lower or two arterial valve mo(u)ld bottom half ventricular septal defect

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Date Code Title Description
C14 Grant of patent or utility model
GR01 Patent grant
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

Effective date: 20090109

C17 Cessation of patent right
CX01 Expiry of patent term

Expiration termination date: 20130321

Granted publication date: 20040414