CN2705131Y - Novel heart atrial septal deffect blocking device - Google Patents

Novel heart atrial septal deffect blocking device Download PDF

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Publication number
CN2705131Y
CN2705131Y CN 200420022071 CN200420022071U CN2705131Y CN 2705131 Y CN2705131 Y CN 2705131Y CN 200420022071 CN200420022071 CN 200420022071 CN 200420022071 U CN200420022071 U CN 200420022071U CN 2705131 Y CN2705131 Y CN 2705131Y
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stopper
disc
left ventricle
septal defect
ventricular septal
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CN 200420022071
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Chinese (zh)
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秦永文
龚善石
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Abstract

This utility model relates to a kind of novel cardiac ventricular septal defect closer, at present, the ventricular septal defect product that has gone on the market also exists many deficiencies both at home and abroad, for this reason, this utility model provides a kind of novel cardiac ventricular septal defect closer, combine by the fixing connecting portion 3 that transmits of nitinol alloy wire support (1), polyester fiber film (2) and a rustless steel, wherein, the left ventricle disc (5) of described stopper is smooth disk, and the left ventricle disc (5) of described stopper has a nitinol alloy wire center joint (7).The disc of a kind of novel cardiac ventricular septal defect closer support left ventricle side that this utility model provides is by special knitting skill, form smooth plane, its sound construction, form is reasonable, and stronger support force arranged, avoid using clinically at present the deficiency of stopper more widely, had good application prospects.

Description

A kind of novel cardiac ventricular septal defect closer
Technical field
This utility model relates to technical field of medical instruments, is specifically related to a kind of novel cardiac ventricular septal defect closer.
Background technology
The congenital heart disease ventricular septal defect is a kind of common congenital heart disease, and the characteristics of pathological changes are to have defective at the interventricular septum between the left and right ventricles in growth course, fails normally closed.Because the pressure of birth back left ventricle is higher than right ventricle, the blood part that causes left ventricle flow to right ventricle through ventricular septal defect punishment, and the burden that causes the right side to feel concerned about system increases, and causes right ventricular hypertrophy, pulmonary circulatory blood volume increases, and finally can cause pulmonary hypertension, arrhythmia and heart failure.Therapeutic room's septal defect was to adopt surgical operation in the past.Surgical operation need be opened breast, and is big to patient trauma, the complication rate height, and stay the operative incision cicatrix.In order to make congenital heart disease ventricular 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 stopper closed-chamber septal defect through cardiac catheter as Rishkind, Sideris and Amplatzer stopper.Find that through clinical practice the Amplatzer stopper is easy to use, curative effect is reliable.But the left ventricle face of its stopper has stainless steel coil to fix, and protrudes in the surface of stopper, is unfavorable for epithelization, and potential thrombosed danger is arranged.Main apparatus through the vessel occlusion ventricular septal defect is a kind of utensil that is used for the closed-chamber septal defect, is called stopper.Stopper is 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 interventricular septum both sides, make damaged closure, reach the purpose of healing.
The type of ventricular septal defect is the important determiner of transcatheter therapy.The ventricular septal defect of vessel occlusion of being suitable for passing through is at least apart from more than the aortic valve 3mm, and damaged diameter is greater than 3mm with less than 10mm.Ventricular 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 ventricular septal defects of different sizes.Heart should be able to be fixed on the ventricular 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 ventricular 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 ventricular 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 rational in infrastructure, a kind of novel cardiac ventricular septal defect closer of being suitable for the membranous ventricular septal defect of different sizes.
A kind of novel cardiac ventricular septal defect closer that this utility model provides is made of superelastic nickel titanium alloy wire, polyester fiber film and transmission coupling part, and 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 that transmits the coupling part be fixedly the NiTi spun gold with the duct that is connected with push rod is provided.
The outward appearance of a kind of novel cardiac ventricular septal defect closer stopper that this utility model provides is the double plate shape of definite shape, and the waist that connects two disks is cylindrical, and disk is bigger than waist diameter.The left ventricle side of stopper is smooth disk, and the right ventricle side has fixed stainless steel coil.Both connect by push rod during application, and the back that puts in place separates both by the counter-rotating push rod.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.
This utility model is woven into flat bottom bags shape by certain route by nitinol alloy wire on mould, one end is used stainless steel coil and is fixed, put between the special outer mold, after heat treatment form certain rule or irregular double plate shape, and the control treatment temperature, reach the super-elasticity and the memory function that need.
A kind of novel cardiac ventricular septal defect closer support liner polyester film that this utility model provides is used medical suture polyester film and holder part is 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 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.
Advantage that this practicality is new and positive effect: 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 muscular ventricular 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 disc of the left ventricle side of a kind of novel cardiac ventricular septal defect closer support that this utility model provides is by special knitting skill, form smooth plane, inflection ring by the nitinol alloy wire of forming support around the planar central point centers on, and run through each inflection ring by the titanium-nickel wire annular of support self and make its connection in aggregates, surface at support does not have riveted joint, its sound construction, form is reasonable.In addition, this 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 6~9F, 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.This utility model elasticity is suitable, and shape is recovered fully, and support force is strong, inserts conveniently, and the location is easy, and curative effect is reliable.
Below, describe details and working condition in conjunction with the accompanying drawings and embodiments in detail according to the concrete device that the utility model proposes.
Description of drawings
The perspective view of the stopper support that Fig. 1 provides for this utility model.
The stopper left ventricle face structural representation that Fig. 2 provides for Fig. 1.
The stopper right ventricle face structural representation that Fig. 3 provides for Fig. 1.
The perspective view of the another kind of asymmetric stopper support that Fig. 4 provides for this utility model.
The stopper left ventricle face structural representation that Fig. 5 provides for Fig. 4.
The stopper right ventricle face structural representation that Fig. 6 Fig. 4 provides.
The specific embodiment
Shown in accompanying drawing 1-6, a kind of novel cardiac ventricular septal defect closer that this utility model embodiment provides is combined by the fixing connecting portion 3 that transmits of nitinol alloy wire support 1, polyester fiber film 2 and a rustless steel.Wherein, described nitinol alloy wire is a stopper support 1; Described polyester fiber film 2 linings are gone into the centre of stopper support 1, play the effect that stops blood flow; Described fixedly transmission connecting portion 3 is positioned at an end of stopper support 1, and effect is fixing described nitinol alloy wire and provides and the push rod transmission part.
A kind of novel cardiac ventricular septal defect closer that this utility model embodiment provides can be symmetric form or asymmetric stopper.
Shown in accompanying drawing 1-3, this utility model embodiment provides a kind of novel ventricular septal heart defect symmetry stopper, the support 1 that it is formed by the nitinol alloy wire braiding, mainly comprise the left ventricle disc 5 of thirty years of age symmetric stopper and the right ventricle disc 4 of stopper in opposite directions, connect the waist 6 of stopper of the right ventricle disc 4 of the left ventricle disc 5 of above-mentioned stopper and stopper, and be positioned at the fixed connecting part 3 that stopper one end links to each other with described right ventricle disc 4; Wherein, the left ventricle disc 5 of described stopper and the right ventricle disc of stopper 4 are symmetrical structure, and the left ventricle disc 5 of described stopper is smooth disk.
As shown in Figure 2, the disc face 5 of the described left ventricle side of a kind of novel cardiac ventricular septal defect closer that this utility model embodiment provides is by special knitting skill, form smooth plane, planar center is the junction of the annular inflection of support braided wires, run through each annular inflection ring by the nitinol alloy wire of forming support self and make its connection in aggregates, do not have riveted joint on the surface of support.And described disc runs through each annular inflection ring by the nitinol alloy wire of forming support self in the center of disc makes it connect into whole stopper support 1.As shown in drawings, disc face 5 profiles of described left ventricle side are as lotus shape in full bloom, and the disc face 5 of above-mentioned left atrium side has a nitinol alloy wire center joint 7, can strengthen this planar force structure greatly, its sound construction, form is reasonable, and stronger support force is arranged.Clockwise direction rotation push rod connects both during application, then is separated from each other when being rotated counterclockwise.The disc face 5 of the described left ventricle side of stopper has good shape memory function, is linear when being subjected to the external force tractive, and external force is recovered original-shape after removing immediately.
As shown in Figure 3, the right ventricle 4 sides one end center of a kind of stopper that this utility model provides has fixedly connected control assembly 3 to use the fixing control of medical stainless steel circle, the stainless steel coil and the main part of right ventricle side 4 are divided into miter angle, described stainless steel coil can link to each other with above-mentioned nitinol alloy wire, can or adopt the kneading technology by solder technology between described screw and the titanium-nickel wire, the preferred kneading technology that adopts should not have solder joint, and adopt the kneading technology to make, its pulling force is better than existing support by being welded at present greatly, and difficult drop-off.
A kind of novel cardiac ventricular septal defect closer that this utility model embodiment provides is woven into flat bottom bags shape by certain route by nitinol alloy wire on mould, one end is used stainless steel coil and is fixed, put between the special outer mold, after heat treatment form symmetric double plate shape, and the control treatment temperature, reach the super-elasticity and the memory function that need.
In clinical practice, select the size of stopper according to the ventricular septal defect diameter of radiography measurement in ultrasonic and the art.Usually select the big 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.
Shown in accompanying drawing 4-6, the asymmetric stopper of a kind of novel ventricular septal heart defect that this utility model embodiment provides, the support 1 that it is formed by the nitinol alloy wire braiding, mainly comprise the left ventricle disc 5 of thirty years of age asymmetrical stopper and the right ventricle disc 4 of stopper in opposite directions, connect the waist 6 of stopper of the right ventricle disc 4 of the left ventricle disc 5 of above-mentioned stopper and stopper, and be positioned at the fixed connecting part 3 that stopper one end links to each other with described right ventricle disc 4; Wherein, the profile of stopper is asymmetrical double plate shape, the waist 6 that connects two disks is cylindrical, left and right sides disk is bigger than waist 6 diameters, the disc of left ventricle 5 sides equates with column part at the aortic valve lateral edges, its offside is than the big 6mm of column part, and the disc edge of right ventricle side is than the big 4mm of body diameter, for symmetric form distributes.
As shown in Figure 5, the disc face 5 of the described left ventricle side of a kind of novel cardiac ventricular septal defect closer that this utility model embodiment provides is by special knitting skill, form smooth plane, planar center is the junction 7 of the annular inflection of support braided wires, run through each annular inflection ring by the nitinol alloy wire of forming support self and make its connection in aggregates, do not have riveted joint on the surface of support.And described disc runs through each annular inflection ring by the nitinol alloy wire of forming support self in the center of disc makes it connect into whole stopper support 1.As shown in drawings, the disc face profile of described left ventricle side 5 is as lotus shape in full bloom, and the disc face 5 of above-mentioned left atrium side has a nitinol alloy wire center joint 7, can strengthen this planar force structure greatly, its sound construction, form is reasonable, and stronger support force is arranged.Clockwise direction rotation push rod connects both during application, then is separated from each other when being rotated counterclockwise.The disc face 5 of the described left ventricle side of stopper has good shape memory function, is linear when being subjected to the external force tractive, and external force is recovered original-shape after removing immediately
As shown in Figure 6, the right ventricle 4 sides one end center of a kind of stopper that this utility model provides has fixedly connected control assembly 3 to use the fixing control of medical stainless steel circle, described stainless steel coil can link to each other with above-mentioned nitinol alloy wire, can or adopt the kneading technology by solder technology between described screw and the titanium-nickel wire, the preferred kneading technology that adopts should not have solder joint, and adopting the kneading technology to make, its pulling force is better than existing support by being welded at present and difficult drop-off greatly.
A kind of novel cardiac ventricular septal defect closer that this utility model embodiment provides is woven into flat bottom bags shape by certain route by nitinol alloy wire on mould, one end is used stainless steel coil and is fixed, 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.
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 big 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.
The advantage of the asymmetric stopper of a kind of novel ventricular septal heart defect that this utility model provides is to adopt state-of-the-art technology technology to make the disc of left ventricle be smooth disk, changed and used the fixed structure of stainless steel coil in the past, left ventricle side discs central point is the Rendezvous Point of braided wires annular inflection ring, run through by support self braided wires annular and respectively to assemble a little, make it form the firm integral body of structure.The stainless steel coil 3 of right ventricle side 4 becomes miter angle with the main part plane, is beneficial to the formation of stopper superficial epithelium.In addition, be irregular distribution at the edge of the disk of left ventricle side and the column part of stopper, it is shorter to be placed on the aortic valve lateral edges, and at its offside, promptly be placed on the longer of apex of the heart side, can be applicable to apart from the nearer ventricular septal defect of aortic valve, reduced probability, therefore have broad prospects the aortic valve damage.
Embodiment 1
The diameter 5mm of membranous ventricular septal defect, its edge is selected the ventricular septal defect of waist diameter 6mm for use apart from more than the aortic valve 3mm, and the left ventricle face sheet diameter of stopper is 10mm, and right ventricle face sheet diameter is 10mm, and the stopper height is 2mm.
Embodiment 2
The diameter 8mm of ventricular septal defect, its edge is selected the ventricular septal defect of waist diameter 10mm for use apart from more than the aortic valve 4mm, and the left ventricle face sheet diameter of stopper is 14mm, and right ventricle face sheet diameter is 14mm, and the stopper height is 2mm.
Embodiment 3
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, disc edge near the aorta side is 0mm, apex of the heart side panel sheet edge is 6mm, and right ventricle face sheet diameter is 9mm, stopper length 2mm.
Embodiment 4
Diameter 8 mm 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, disc edge near the aorta side is 0mm, apex of the heart side panel sheet edge is 6mm, and right ventricle face sheet diameter is 14mm, and stopper length is 2mm.

Claims (7)

1, a kind of novel cardiac ventricular septal defect closer, combine by the fixing connecting portion 3 that transmits of nitinol alloy wire support (1), polyester fiber film (2) and a rustless steel, wherein, described nitinol alloy wire is stopper support (1), described polyester fiber film (2) lining is gone into the centre of stopper support (1), and described fixedly transmission connecting portion (3) is positioned at an end of stopper support (1); It mainly comprises in opposite directions thirty years of age the left ventricle disc (5) of stopper and the right ventricle disc (4) of stopper, the waist (6) of stopper that connects the right ventricle disc (4) of the left ventricle disc (5) of above-mentioned stopper and stopper, and be positioned at the fixed connecting part (3) that stopper one end links to each other with described right ventricle disc (4), the left ventricle disc (5) of described stopper is smooth disk, it is characterized in that the left ventricle disc (5) of described stopper has a nitinol alloy wire center joint (7).
2, a kind of novel cardiac ventricular septal defect closer according to claim 1 is characterized in that described stopper is symmetric form or asymmetric stopper.
3, a kind of novel cardiac ventricular septal defect closer according to claim 1, it is characterized in that the planar center of described left ventricle disc (5) is the junction of the annular inflection of support braided wires, run through each annular inflection ring by the nitinol alloy wire of forming support self and make its connection in aggregates.
4, a kind of novel cardiac ventricular septal defect closer according to claim 1 is characterized in that described left ventricle disc (5) runs through each annular inflection ring by the nitinol alloy wire of forming support self and makes it connect into whole stopper support (1) in the center of disc.
5, a kind of novel cardiac ventricular septal defect closer according to claim 1, the disc face profile that it is characterized in that described left ventricle side (5) is as lotus shape in full bloom.
6, a kind of novel cardiac ventricular septal defect closer according to claim 1, the disc face (5) that it is characterized in that described left ventricle side are linear when being subjected to the external force tractive.
7, a kind of novel cardiac ventricular septal defect closer according to claim 1 is characterized in that the stainless steel coil (3) of described right ventricle side (4) becomes miter angle with the main part plane.
CN 200420022071 2004-04-21 2004-04-21 Novel heart atrial septal deffect blocking device Expired - Lifetime CN2705131Y (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104173080A (en) * 2014-07-21 2014-12-03 上海形状记忆合金材料有限公司 Occlusion 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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104173080A (en) * 2014-07-21 2014-12-03 上海形状记忆合金材料有限公司 Occlusion 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

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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

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

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CX01 Expiry of patent term

Expiration termination date: 20140421

Granted publication date: 20050622