CN2524710Y - New cardiac atrial septal defect blocking device - Google Patents
New cardiac atrial septal defect blocking device Download PDFInfo
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- CN2524710Y CN2524710Y CN 01274500 CN01274500U CN2524710Y CN 2524710 Y CN2524710 Y CN 2524710Y CN 01274500 CN01274500 CN 01274500 CN 01274500 U CN01274500 U CN 01274500U CN 2524710 Y CN2524710 Y CN 2524710Y
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- stopper
- septal defect
- atrial septal
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Abstract
The utility model relates to the technical field of medical appliances and in particular relates to a sealing stop device utilized to treat the atrial septal defect of congenital heart disease; the prior sealing stop device has a plurality of shortcomings. The utility model provides the novel heart atrial septal defect sealing stop device woven by a remembering metal alloy wires, which mainly comprises a supporting frame (1) made of super elasticity nitinol wires, the supporting frame (1) lined into the sealing stop device, a polyester fiber film separating layer (2) in the middle and a transmission connecting controlled part (3) fixed on one end of the sealing stop device supporting frame (1). The utility model has the advantages that a round disk besides the left heart chamber is manufactured by one unique metal nitinol wire weaving technique; hence the round disk is neat; meanwhile, the newer technical proposal is adopted to facilitate the connection between a ni-ti wire and a stainless steel screw to has no welded point and avoid the doffing wire caused by the infirm welding connection between a ni-ti wire and a steel sleeve; therefore, the utility model has wide application prospect.
Description
Technical field
This utility model relates to technical field of medical instruments, is specifically related to a kind of novel heart atrial septal defect plugging device.
Background technology
The congenital heart disease atrial septal defect is a kind of common congenital heart disease; the characteristics of pathological changes are that normally closed is failed in the interatrial septum between left atrium; because the pressure of left atrium is higher than right atrium; under pressure; the blood part of left atrium flow to right atrium through atrial 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.Be surgical operation to the damaged traditional Therapeutic Method in room, and surgical operation need be opened breast in the past, big to patient trauma, the complication rate height, and stay the scar of operative incision at body surface.Adopt the interventional method treatment of Wicresoft for the patient who makes the congenital heart disease atrial septal defect, since 1976, successively invented multiple shutoff equipment both at home and abroad, explored to use and send into the closed atrial septal defect of stopper, reached the curative effect suitable with the surgery open chest surgery through the heart conduit.The complication that can avoid simultaneously transfusing blood and cause by blood transfusion and surgical operation.
Main apparatus through the vessel occlusion atrial septal defect is a kind of utensil that is used for closed atrial septal defect, is called stopper.Stopper becomes dual disc, and the stopper disc mainly contains superelastic metal alloy silk textile faces, sends into the position of heart defect through cardiac catheter, release the shape that the back is recovered design automatically from conduit, be clipped in damaged both sides, interatrial septum, make damaged closure, reach the purpose of healing.
The man medical apparatus corporation, Ltd of existing in the world number is at the development stopper, and the product of listing has CardioSEAL and Amplatzer stopper etc. at present.Show that through a large amount of clinical researches the type of atrial septal defect is the important determiner of transcatheter therapy.The lesion characteristic of vessel occlusion of being suitable for passing through is that atrial septal defect has the above edge of 5mm at least, and damaged from coronary sinus, pulmonary vein and Bicuspid valve with more than the Tricuspid valve 5mm, the diameter of atrial septal defect is greater than 5mm with less than 40mm.Atrial septal defect is not of uniform size, and form is also irregular, needs stopper that the shape number of different-diameter is arranged, to adapt to different big or small atrial septal defects.Heart should be able to be fixed on the atrial septal defect place beating of not stopping after stopper puts in place reliably.Can stopper be fixed reliably, and the factor of its decision is to select the hardness of stopper size and stopper support.Stopper hardness is big, and resilient beam helps fixing, but hardness is unfavorable for that too greatly stopper is transported to atrial septal defect through conduit, also is unfavorable for withdrawing from when defective external as the big ting model of selecting.Therefore require the hardness of metal rack of stopper suitable.The hardness of stopper depends primarily on the thickness of nitinol alloy wire and super elastic characteristics after heat treatment.Because patients with atrial septal defect mostly is the child, blood vessel is thinner, and inserting endovascular delivery sheath 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.In addition, the stopper surface should be smooth smooth, make it to be difficult for to form thrombosis on its surface, so 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 just provides a kind of rational in infrastructure, stopper of being suitable for different big or small ostium secundum defects.
A kind of stopper that is used for the treatment of the congenital heart disease atrial septal defect that this utility model provides has the braiding of Memorability metal alloy wires by one and forms, and it comprises that mainly the stake body of nitinol alloy wire, intermediary polyester fiber film barrier layer and a transmission are connected control part.
A kind of stopper support that this utility model provides is woven into two flat bottom bags shape cylindrical stents by certain route by a nitinol alloy wire on mould, the transmission of one end connects control and uses the fixing control of medical stainless steel screw, should there be solder joint between 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; Simultaneously, above-mentioned screw tilts into the certain angle of support planar base surface, like this, can help tissue in the stopper superficial epitheliumization.On the other end of described metal rack, there is a special inclination to go into the certain angle inclined-plane of support planar base surface, like this, can helps tissue equally in the stopper superficial epitheliumization.
The stopper that this utility model provides is put between the special outer mold, after heat treatment forms the double plate shape, and the control treatment temperature, reaches the super-elasticity and the memory function that need.
Go into the multi-layered polyester fibrous membrane at the support liner in the middle of the stopper that this utility model provides, use medical suture polyester fiber film and support are stitched together, so just played the effect that intercepts blood flow.
During operation, earlier 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 atrium place by push rod, the disc of left atrium opens by the super-elasticity of self after going out sheath, the place, scarce hole to the room pulls back, the left atrium face of ultrasonic demonstration stopper is positioned at the left atrium side, if any resistance, and fixing push rod then, return and remove the sheath pipe, discharge the right atrium disc, the disc of both sides is clipped in the both sides of atrial septal defect by the super-elasticity complex effect of self, as pushing and stopper fixed-site when pulling back, do not influence the function of adjoining part, then can discharge stopper, finish operation.
Advantage of the present utility model and positive effect are made the disk of left atrium side for a metal titanium-nickel wire knitting skill having adopted uniqueness owing to the new shape of this practicality, make it smooth, adopt state-of-the-art technology technology to make titanium-nickel wire be connected no solder joint with CARBURIZING FURNACE FOR STAINLESS FASTENER simultaneously, can be and cause running as titanium-nickel wire and steel bushing not prison welding.In addition, this practical in the left atrium side all by nitinol alloy wire braiding, surface finishing helps stopper and implants epithelium posterius formation, reduces because of left atrium face polishing and can produce thrombotic complication not.Also have, the stopper that this utility model provides is to form through special braiding, can become linear behind the stressed tractive, can send into the atrial septal defect place by the sheath pipe of 6～12F, and is all lighter to point of puncture and blood vessel injury.Promptly only need about appearance percutaneous incision skin 3mm, can finish the shutoff treatment of atrial septal defect.
The stopper left atrium face structural representation that description of drawings Fig. 1 provides for this utility model.The stopper right atrium face structural representation that Fig. 2 provides for this utility model.The perspective view of the stopper support that Fig. 3 provides for this utility model.Fig. 4 connects the pulling-out force test pattern of control part for this utility model transmission.Fig. 5 connects the pulling-out force test pattern of control part for the transmission of existing stopper.
Specific implementation method
As shown in drawings, a kind of stopper that is used for the treatment of the congenital heart disease atrial septal defect that this utility model provides has the braiding of Memorability metal alloy wires by one and forms, and it mainly comprises: the support 1 intermediary polyester fiber film barrier layer 2 that the support 1 of superelastic nickel titanium alloy wire, lining are gone into above-mentioned stopper is connected control part 3 with a transmission that is fixed on above-mentioned stopper support 1 one ends.
Nitinol alloy wire described in the utility model has constituted the support 1 of stopper, this metal has memory function, can pre-determine the shape that needs expandable stent, support is compressed in the thinner sheath pipe then and send into inside of human body, arrival can return to original shape behind the precalculated position.
Polyester fiber film barrier layer 2 linings that this utility model provides are gone into the centre of the support 1 of above-mentioned stopper, play the effect that stops blood flow; Transmission connects the end that control part 3 is positioned at above-mentioned stopper support 1, and its effect is that fixedly nitinol alloy wire spins with providing and controlling push rod.
As shown in Figure 3, the profile of the stopper support 1 that this utility model provides is the double-face circular disc shape, and waist 4 diameters that connect two disks are less than two ends, and are cylindrical; Wherein, the left atrium side of described stopper support 1 is the smooth disk 5 of center to lower recess, and it is that transmission connects control part 3 that the right atrium side has hold-down nut.
The transmission of a kind of stopper support 1 right atrium side one end that this utility model provides connects control part 3 and uses the fixing control of medical stainless steel screw, described CARBURIZING FURNACE FOR STAINLESS FASTENER outer end has screw thread can connect push rod, inner hollow, 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. 4, shown in Figure 5, 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.
Also have, as shown in Figure 3, the screw that above-mentioned transmission connects control part 3 tilts into the certain angle of support planar base surface, like this, can extremely help tissue in the stopper superficial epitheliumization.
In addition, as shown in Figure 1, on the other end of described stopper support 1, there is a special inclination to go into the certain angle inclined-plane 5 of support planar base surface, like this, can helps tissue equally in the stopper superficial epitheliumization.
During application, clockwise direction rotation push rod connects both, then is separated from each other when being rotated counterclockwise.Stopper has good memory function, is strip when being subjected to external force traction, and external force is recovered original-shape after removing immediately.
In clinical practice, select the size of stopper according to the atrial septal defect diameter of sacculus measurement in ultrasonic and the art.Usually select the size of stopper damaged consistent with the room that sacculus is measured basically.Stopper is delivered to left atrium through delivery sheath, at first opens the waist of left atrium face and stopper in left atrium, pulls back to lack in the hole to the room, returns and removes the sheath pipe, discharges the disc of right atrium face.Under guiding, ultrasonic and X line determine the implantation position and the plugging effect of stopper.
Ostium secundum defect diameter 15mm, its centroid roof, edge portion, Bicuspid valve, Tricuspid valve, more than the pulmonary vein opening 5mm.Select the atrial septal defect plugging device of waist diameter 15mm for use.The left atrium face sheet diameter of stopper is 29mm, the diameter 26mm of right atrium face.
Ostium secundum defect diameter 40mm, its centroid roof, edge portion, Bicuspid valve, Tricuspid valve, more than the pulmonary vein opening 5mm.Select the atrial septal defect plugging device of waist diameter 40mm for use.The left atrium face diameter of stopper is 54mm, the disc diameter 51mm of right atrium face.
Claims (4)
1, a kind of novel heart atrial septal defect plugging device, it is characterized in that this stopper has the braiding of Memorability metal alloy wires by one and forms, it mainly comprises: support (1) the intermediary polyester fiber film barrier layer (2) that the support of superelastic nickel titanium alloy wire (1), lining are gone into above-mentioned stopper is connected control part (3) with a transmission that is fixed on above-mentioned stopper support (1) one end.
2, a kind of novel heart atrial septal defect plugging device according to claim 1 is characterized in that the profile of described support (1) is the double-face circular disc shape, and waist (4) diameter that connects two disks is less than two ends, and is cylindrical; Wherein, the left atrium side of described stopper support (1) is the smooth disk (5) of center to lower recess, and it is that transmission connects control part (3) that the right atrium side has hold-down nut.
3, a kind of novel heart atrial septal defect plugging device according to claim 1 is characterized in that described transmission connects control part (3) and uses the fixing control of medical stainless steel screw, should not have solder joint between screw and the titanium-nickel wire, but adopts the kneading technology to make.
4, a kind of novel heart atrial septal defect plugging device according to claim 1 is characterized in that described transmission connects the certain angle of the oblique support planar base surface of control part (3).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01274500 CN2524710Y (en) | 2001-12-27 | 2001-12-27 | New cardiac atrial septal defect blocking device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01274500 CN2524710Y (en) | 2001-12-27 | 2001-12-27 | New cardiac atrial septal defect blocking device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN2524710Y true CN2524710Y (en) | 2002-12-11 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 01274500 Expired - Lifetime CN2524710Y (en) | 2001-12-27 | 2001-12-27 | New cardiac atrial septal defect blocking device |
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| CN (1) | CN2524710Y (en) |
Cited By (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100381185C (en) * | 2002-07-16 | 2008-04-16 | 王安勤 | Memory-type plug rack and its making process |
| CN100444811C (en) * | 2006-01-16 | 2008-12-24 | 孔祥清 | Automatically positioned left auricle block instrument |
| 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 |
| EP2526875A2 (en) | 2007-04-16 | 2012-11-28 | Occlutech Holding AG | Occluder for occluding an atrial appendage |
| 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 |
| 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 |
| 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 |
| CN105658148A (en) * | 2013-06-26 | 2016-06-08 | W.L.戈尔及同仁股份有限公司 | Occlusive device |
| CN106510777A (en) * | 2016-12-09 | 2017-03-22 | 上海形状记忆合金材料有限公司 | Atrial shunt |
| CN107157527A (en) * | 2011-11-08 | 2017-09-15 | W.L.戈尔及同仁股份有限公司 | Sealing device and delivery system |
| WO2019073480A1 (en) * | 2017-10-13 | 2019-04-18 | Sree Chitra Tirunal Institute For Medical Sciences And Technology | Implantable atrial septal defect occlusion device with woven central section on left atrial flange |
| CN109925096A (en) * | 2019-04-29 | 2019-06-25 | 上海方维医疗科技有限公司 | For reducing the device of annulus of mitral valve opening area |
| CN110236606A (en) * | 2019-06-13 | 2019-09-17 | 广州启骏生物科技有限公司 | Postinfarction ventricular septal defect plugging device |
| US10485525B2 (en) | 2007-04-05 | 2019-11-26 | W.L. Gore & Associates, Inc. | Septal closure device with centering mechanism |
| US10792025B2 (en) | 2009-06-22 | 2020-10-06 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| US10806437B2 (en) | 2009-06-22 | 2020-10-20 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| US10828019B2 (en) | 2013-01-18 | 2020-11-10 | W.L. Gore & Associates, Inc. | Sealing device and delivery system |
| US11298116B2 (en) | 2014-06-06 | 2022-04-12 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| WO2022121300A1 (en) | 2020-12-11 | 2022-06-16 | 上海捍宇医疗科技股份有限公司 | Puncturable interatrial septum occluder |
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2001
- 2001-12-27 CN CN 01274500 patent/CN2524710Y/en not_active Expired - Lifetime
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| CN100381185C (en) * | 2002-07-16 | 2008-04-16 | 王安勤 | Memory-type plug rack and its making process |
| US11375988B2 (en) | 2003-07-14 | 2022-07-05 | W. L. Gore & Associates, Inc. | Patent foramen ovale (PFO) closure device with linearly elongating petals |
| US8777974B2 (en) | 2004-03-19 | 2014-07-15 | Aga Medical Corporation | Multi-layer braided structures for occluding vascular defects |
| 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 |
| 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 |
| CN100444811C (en) * | 2006-01-16 | 2008-12-24 | 孔祥清 | Automatically positioned left auricle block instrument |
| US10743852B2 (en) | 2006-03-24 | 2020-08-18 | Occlutech Holding Ag | Occlusion device and method for its manufacture |
| US9532772B2 (en) | 2006-03-24 | 2017-01-03 | Occlutech Holding Ag | Occlusion device and method for its manufacture |
| US11751858B2 (en) | 2006-03-24 | 2023-09-12 | Occlutech Gmbh | Occlusion device and method for its manufacture |
| EP2389869A3 (en) * | 2006-03-24 | 2014-10-22 | Occlutech Holding AG | Occlusion instrument and method for its production |
| EP1998686B2 (en) † | 2006-03-24 | 2018-02-21 | Occlutech Holding AG | 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 |
| 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 |
| EP2266465A1 (en) * | 2006-03-24 | 2010-12-29 | Occlutech GmbH | Occlusion instrument and method for its production |
| EP2389870A3 (en) * | 2006-03-24 | 2012-09-12 | Occlutech Holding AG | Occlusion instrument and method for its production |
| EP2389872A3 (en) * | 2006-03-24 | 2012-09-05 | Occlutech Holding AG | Occlusion instrument and method for its production |
| US10485525B2 (en) | 2007-04-05 | 2019-11-26 | W.L. Gore & Associates, Inc. | Septal closure device with centering mechanism |
| EP2526875A3 (en) * | 2007-04-16 | 2015-06-10 | Occlutech Holding AG | Occluder for occluding an atrial appendage |
| EP2581045A3 (en) * | 2007-04-16 | 2015-06-10 | Occlutech Holding AG | Occluder and production process therefor |
| EP2526875A2 (en) | 2007-04-16 | 2012-11-28 | Occlutech Holding AG | Occluder for occluding an atrial appendage |
| EP2581045A2 (en) | 2007-04-16 | 2013-04-17 | Occlutech Holding AG | Occluder and production process therefor |
| 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 |
| US11589853B2 (en) | 2009-06-22 | 2023-02-28 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| US11596391B2 (en) | 2009-06-22 | 2023-03-07 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| US10792025B2 (en) | 2009-06-22 | 2020-10-06 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| US10806437B2 (en) | 2009-06-22 | 2020-10-20 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| US11564672B2 (en) | 2009-06-22 | 2023-01-31 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| CN107157527A (en) * | 2011-11-08 | 2017-09-15 | W.L.戈尔及同仁股份有限公司 | Sealing device and delivery system |
| US11771408B2 (en) | 2013-01-18 | 2023-10-03 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| US10828019B2 (en) | 2013-01-18 | 2020-11-10 | W.L. Gore & Associates, Inc. | Sealing device and delivery system |
| CN105658148A (en) * | 2013-06-26 | 2016-06-08 | W.L.戈尔及同仁股份有限公司 | Occlusive device |
| US11298116B2 (en) | 2014-06-06 | 2022-04-12 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
| CN106510777A (en) * | 2016-12-09 | 2017-03-22 | 上海形状记忆合金材料有限公司 | Atrial shunt |
| WO2019073480A1 (en) * | 2017-10-13 | 2019-04-18 | Sree Chitra Tirunal Institute For Medical Sciences And Technology | Implantable atrial septal defect occlusion device with woven central section on left atrial flange |
| CN109925096A (en) * | 2019-04-29 | 2019-06-25 | 上海方维医疗科技有限公司 | For reducing the device of annulus of mitral valve opening area |
| CN110236606A (en) * | 2019-06-13 | 2019-09-17 | 广州启骏生物科技有限公司 | Postinfarction ventricular septal defect plugging device |
| WO2022121300A1 (en) | 2020-12-11 | 2022-06-16 | 上海捍宇医疗科技股份有限公司 | Puncturable interatrial septum occluder |
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Legal Events
| Date | Code | Title | Description |
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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: 199, Tongji Road, Shanghai, Baoshan District, China: 200940 Co-patentee before: Qin Yongwen Patentee before: Gong Shan Shi |
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| 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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| C17 | Cessation of patent right | ||
| CX01 | Expiry of patent term |
Expiration termination date: 20111227 Granted publication date: 20021211 |