CN104414692A - Irregular plugging device for heart interventricular septum - Google Patents

Irregular plugging device for heart interventricular septum Download PDF

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Publication number
CN104414692A
CN104414692A CN201310364742.8A CN201310364742A CN104414692A CN 104414692 A CN104414692 A CN 104414692A CN 201310364742 A CN201310364742 A CN 201310364742A CN 104414692 A CN104414692 A CN 104414692A
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China
Prior art keywords
umbrella
waist
elastic network
millimeters
welded
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Withdrawn
Application number
CN201310364742.8A
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Chinese (zh)
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赵菁
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Individual
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Individual
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Priority to CN201310364742.8A priority Critical patent/CN104414692A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00597Implements comprising a membrane
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00601Implements entirely comprised between the two sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

An irregular plugging device for a heart interventricular septum comprises an elastic network and sealing membranes, wherein a waist drum shaped waist, of which the middle diameter is gradually reduced, is arranged in the middle of the elastic network; the left end and the right end of the waist are respectively connected with a disk-shaped left umbrella and a disk-shaped right umbrella; a plurality of alloy yarn ends forming the elastic network are folded on the outer sides of the left umbrella and the right umbrella; an end socket for folding the alloy yarn ends for fixation is welded on the outer side of the left umbrella; a connector for folding the alloy yarn ends for fixation is welded on the outer side of the right umbrella; a screw hole used for being screwed with a conveying steel cable is formed in the middle of the connector; and a butterfly elastic network welded with the connector has high elasticity after heat treatment, and then a layer of polytetrafluoroethylene diaphragm seal for blocking blood is sewn in each of the left umbrella and the right umbrella. The irregular plugging device has the superiorities that the upper part of the waist is narrow, and the lower part of the waist is wide, so that the physiological features of interventricular septum are met, the blood leakage can be prevented effectively, the excessive oppression to muscular parts is overcome, and the long-term adverse effects caused after the plugging device is implanted into a human body are reduced.

Description

Abnormity cardiac septum stopper
Technical field
The present invention relates to a kind of medical occluder, particularly a kind of special-shaped cardiac septum stopper for Surgery Congenital Heart ventricular septal defect.
Background technology
Congenital heart disease atrial septal defect and ventricular septal defect are all common congenital heart disease, and the feature of its pathological changes of heart atrial septal defect is that normally closed is failed at interval between left atrium, and blood flows between left atrium and right atrium; The feature of its pathological changes of ventricular septal defect is that normally closed is failed at interval between left and right ventricles, and blood is flowed between left ventricle and right ventricle.Because the pressure of left atrium is higher than right atrium, so the part blood of left atrium flows to right atrium through atrial septal defect punishment.Due to the leakage of blood, the burden causing the right side to feel concerned about system increases, and causes right ventricular hypertrophy, pulmonary hypertension, arrhythmia and heart failure.Just need when heart septal defect causes blood leakage more to repair septal defect place.Surgical operation is the traditional method for the treatment of heart septal defect, and its shortcoming needs to open breast, wound greatly to patient, and complication rate is high, recovery is slow.
Since the eighties in last century, Wicresoft's interventional therapy progressively becomes the first-selection for the treatment of ventricular septal heart defect, and at present, existing multiple cardiac ventricular septal defect closer is used to treatment Congenital Heart ventricular septal defect.The main body of stopper is a butterfly net, and it is one has memory preset profiles and can become the metallic elastic net for strip when being subject to force-extension, and after external force is removed, elastic network(s) can recover its preset profiles.Be cylindrical eel-like figure in the middle of the elastic network(s) of formation stopper, respectively there is a double-layer hollow disk at eel-like figure two ends, and be provided with the diaphragm seal that one deck intercepts blood flow in each disk, elastic network(s) two ends are also welded with joint.But because its anatomical structure of difference at heart defect position is also not quite similar, so just require that we must design the special-shaped stopper of different structure according to the physiological structure of interventricular septum.
Interventricular septum is divided into membranous part and pars muscularis two large divisions, and membranous part is mainly made up of fibrous tissue, and both side surface is covered by right atrium and left and right ventricles inner membrance, and not containing muscle and blood vessel, its thickness is not as good as 1 millimeter; And pars muscularis thickness is 5 ~ 12 millimeters, average out to 8 millimeters.Existing its waist thickness of heart membranous ventricular septal defect stopper is even, do not meet the physiological structure of interventricular septum, the pine of the tight opposite side clamping making stopper side clamp after loading onto by force, the side of pine is handed over easily to produce leakage in clamping, simultaneously its top projection of existing stopper is relatively excessive, adds the probability with the vital tissue structural collision such as aortic valve.
Summary of the invention
The object of the invention is to the defect and the deficiency that make up prior art, a kind of special-shaped cardiac septum stopper is provided, it designs according to the special physiological structure of interventricular septum, use when being particularly suitable for membranous ventricular septal defect shutoff, its top is narrower and umbrella top is lower, decreases the probability with vital tissue structural collision on interventricular septum wall.The main body of this stopper is butterfly elastic network(s), it is woven by superelastic metal silk to form, stopper is drawn into cardiac catheter and after sending into heart septal defect position, automatically the butterfly of original design can be recovered when releasing from conduit, be clipped in the both sides, ventricular septum of defect, defect is closed, reaches the object of healing.
For achieving the above object, the technical solution used in the present invention is as follows: a kind of special-shaped cardiac septum stopper, comprise elastic network(s) and diaphragm seal, described elastic network(s) is by nitinol alloy wire butterfly elastic network(s) through braiding on mould, it is the main part of stopper, large centre, butterfly elastic network(s) two is little, the middle part of elastic network(s) is the waist of a diminishing waist drum shape of mid diameter, the diameter at waist two ends is than 1 ~ 3 millimeter broad in the middle, the two ends, left and right of waist respectively connected discoid left umbrella and right umbrella, left umbrella and right umbrella are double seal formula structure, because waist is the waist drum shape that centre reduces, so left umbrella and right umbrella can opposing oscillatory and movements under the effect of external force, the silk head of several B alloy wires of formation elastic network(s) draws the outside at left umbrella and right umbrella in, outside left umbrella, be welded with one draw the silk head of B alloy wire in fixing end socket, outside right umbrella, be welded with one draw the silk head of B alloy wire in fixing joint, one is had for the screw of the conveying wirerope that spins in the middle part of joint, described end socket and joint are made by Nitinol, excessively connect by arc surface between each face of butterfly elastic network(s), overall level and smooth without corner angle, the orthographic projection of waist is trapezoidal, top is because close membranous part is so its width is 1 millimeter, below because close pars muscularis is so width is 3 millimeters, the diameter of waist, slightly larger than the size at membranous ventricular septal defect place, is generally 2 ~ 8 millimeters, and the upper end of left umbrella exceeds 0.5 millimeter, waist, can avoid like this injuring aortic valve, the upper end of right umbrella exceeds 2 millimeters, waist, and the lower end of left umbrella exceeds 3 millimeters, waist, and the lower end of right umbrella exceeds 2 millimeters, waist.The butterfly elastic network(s) being welded with joint has high resiliency again after heat treatment, in left umbrella and right umbrella, then respectively makes the teflon seal film that one deck intercepts blood, finally check, sterilize, sterilize, pack.This stopper has good shape memory function, when the joint of axial tractive butterfly stopper, stopper can be drawn in conduit and become strip, and when stopper being released from conduit, stopper can recover original butterfly immediately again.
Superiority of the present invention is that the top narrow lower portion of waist is wide, such top can be adjacent to the thinner membranous part left and right sides, and bottom can be adjacent to wider pars muscularis both sides, more meet the physiological feature of interventricular septum, effectively can prevent blood leakage, overcome the excessive compressing of traditional stopper to pars muscularis simultaneously, and the side effect brought thus, reduce the untoward reaction at a specified future date after shutoff implant into body.
Another superiority of the present invention is that the upper end of left umbrella is lower, can reduce the collision with vital tissue structure on interventricular septum wall like this, improve operation Long-Term Safety equally.
Another superiority of the present invention is that waist is the waist drum shape that centre reduces, and the angle between left like this umbrella and right umbrella can shrink adjustment automatically according to the practical situation at ventricular septal defect place, and what the inner side of left umbrella and right umbrella and interventricular septum were depended on is tightr.
Using method of the present invention: open an osculum at femoral vein place, insert wire to set up through the track of femoral vein to cardiac septum position, conduit is inserted through track, then the stopper being connected with conveying wirerope is pushed conduit and deliver to left room together, under the supervision of X-ray and color ultrasound, slowly stopper is opened after determining defect, first we open left umbrella, then pull back and carry wirerope and conduit, side ring surface and left locular wall in left umbrella are fitted, after determining that laminating is good, slowly open the waist of stopper again, determine to open right umbrella again after waist and defect relative position are well, make the left side of spaced walls by stopper originally having defect, right two umbrella covers are clamped, defect is closed, reach the object of clinical cure.
Accompanying drawing explanation
Fig. 1 is front view of the present invention.
Fig. 2 is profile of the present invention.
Fig. 3 is the A-A sectional view in Fig. 1.
Fig. 4 is the B-B sectional view in Fig. 1.
Fig. 5 is the A direction view in Fig. 1.
In figure, 1. elastic network(s), 2. waist, 3. left umbrella, 4. right umbrella, 5,6. diaphragm seal, 7. end socket, 8. joint, 9. screw.
Detailed description of the invention
In figure, a kind of special-shaped cardiac septum stopper, comprise elastic network(s) 1 and diaphragm seal 5, 6, described elastic network(s) 1 is by nitinol alloy wire butterfly elastic network(s) through braiding on mould, it is the main part of stopper, the middle part of elastic network(s) 1 is the waist 2 of a diminishing waist drum shape of mid diameter, the two ends, left and right of waist 2 respectively connected discoid left umbrella 3 and right umbrella 4, left umbrella 3 and right umbrella 4 are double seal formula structure, because waist 2 is the diminishing waist drum shape of mid diameter, so left umbrella and right umbrella can opposing oscillatory and movements under the effect of external force, the silk head of several B alloy wires of formation elastic network(s) 1 draws the outside at left umbrella 3 and right umbrella 4 in, be welded with one in the outside of left umbrella 3 and draw the silk head of B alloy wire on the left of elastic network(s) 1 in fixing end socket 7, outside right umbrella 4, be welded with one draw the silk head of B alloy wire on the right side of elastic network(s) 1 in fixing joint 8, one is had for the screw 9 of the conveying wirerope that spins in the middle part of joint 8, described end socket 7 and joint 8 are made by Nitinol, the orthographic projection of waist 2 is trapezoidal, its top is because close membranous part is so its width is 1 millimeter, it is below because close pars muscularis is so width is 3 millimeters, the diameter of waist 2 is slightly larger than the size at membranous ventricular septal defect place, be generally 2 ~ 8 millimeters, the upper end of left umbrella 3 exceeds about 0.5 millimeter, waist 2, and the upper end of right umbrella 4 exceeds about 2 millimeters, waist 2, the lower end of left umbrella 3 exceeds about 3 millimeters, waist 2, and the lower end of right umbrella 4 exceeds about 2 millimeters, waist 2.The elastic network(s) 1 being welded with end socket 7 and joint 8 is provided with high resiliency after heat treatment, in left umbrella 3 and right umbrella 4, then respectively makes the teflon seal film 5,6 that one deck intercepts blood, finally check, sterilize, sterilize, pack.This stopper and have good shape memory function, when the joint 8 of axial tractive stopper, stopper can be drawn in conduit and make it become strip, when stopper is released from conduit, stopper can recover original butterfly immediately.

Claims (2)

1. a special-shaped cardiac septum stopper, comprise elastic network(s) and diaphragm seal, it is characterized in that: described elastic network(s) is by nitinol alloy wire butterfly elastic network(s) through braiding on mould, it is the main part of stopper, the middle part of elastic network(s) is the waist of a diminishing waist drum shape of mid diameter, the two ends, left and right of waist respectively connected discoid left umbrella and right umbrella, left umbrella and right umbrella are double seal formula structure, the silk head of several B alloy wires of formation elastic network(s) draws the outside at left umbrella and right umbrella in, outside left umbrella, be welded with one draw the silk head of B alloy wire in fixing end socket, outside right umbrella, be welded with one draw the silk head of B alloy wire in fixing joint, one is had for the screw of the conveying wirerope that spins in the middle part of joint, the orthographic projection of waist is trapezoidal, top width is 1 millimeter, following width is 3 millimeters, the diameter of waist is 2 ~ 8 millimeters, the upper end of left umbrella exceeds 0.5 millimeter, waist, the upper end of right umbrella exceeds 2 millimeters, waist, the lower end of left umbrella exceeds 3 millimeters, waist, the lower end of right umbrella exceeds 2 millimeters, waist, the teflon seal film that one deck intercepts blood is respectively made in left umbrella and right umbrella.
2. special-shaped cardiac septum stopper according to claim 1, is characterized in that: the diameter at described waist two ends is than 1 ~ 3 millimeter broad in the middle.
CN201310364742.8A 2013-08-21 2013-08-21 Irregular plugging device for heart interventricular septum Withdrawn CN104414692A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201310364742.8A CN104414692A (en) 2013-08-21 2013-08-21 Irregular plugging device for heart interventricular septum

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201310364742.8A CN104414692A (en) 2013-08-21 2013-08-21 Irregular plugging device for heart interventricular septum

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CN104414692A true CN104414692A (en) 2015-03-18

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020018699A1 (en) * 2018-07-18 2020-01-23 W. L. Gore & Associates, Inc. Medical devices for shunts, occluders, fenestrations and related systems and methods
CN111110288A (en) * 2020-01-14 2020-05-08 赵天力 Ventricular septal defect occluder and preparation method thereof
CN111820963A (en) * 2020-08-17 2020-10-27 复旦大学附属中山医院 Novel double-layer plugging device
US11540731B2 (en) 2018-12-21 2023-01-03 W. L. Gore & Associates, Inc. Medical treatment system using measurement data from multiple sensors

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020018699A1 (en) * 2018-07-18 2020-01-23 W. L. Gore & Associates, Inc. Medical devices for shunts, occluders, fenestrations and related systems and methods
AU2019308262B2 (en) * 2018-07-18 2022-08-04 W. L. Gore & Associates, Inc. Medical devices for shunts, occluders, fenestrations and related systems and methods
US11540731B2 (en) 2018-12-21 2023-01-03 W. L. Gore & Associates, Inc. Medical treatment system using measurement data from multiple sensors
US11911135B2 (en) 2018-12-21 2024-02-27 W. L. Gore & Associates, Inc. Implantable medical device with adjustable blood flow
CN111110288A (en) * 2020-01-14 2020-05-08 赵天力 Ventricular septal defect occluder and preparation method thereof
CN111820963A (en) * 2020-08-17 2020-10-27 复旦大学附属中山医院 Novel double-layer plugging device

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C04 Withdrawal of patent application after publication (patent law 2001)
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Application publication date: 20150318