CN100396246C - Blockage for septal defect between cardiac atrium and ventricle - Google Patents
Blockage for septal defect between cardiac atrium and ventricle Download PDFInfo
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- CN100396246C CN100396246C CNB2004100673525A CN200410067352A CN100396246C CN 100396246 C CN100396246 C CN 100396246C CN B2004100673525 A CNB2004100673525 A CN B2004100673525A CN 200410067352 A CN200410067352 A CN 200410067352A CN 100396246 C CN100396246 C CN 100396246C
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- heart
- septal defect
- stopper
- room
- ventricular septal
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Abstract
The present invention relates to a medical appliance implanted in the heart of a human body, concretely, a blocking apparatus for cardiac atrium and ventricle septal defects. The purpose is to provide a medical appliance which can not cause ectopic blocking due to the falling of the blocking apparatus; the present invention can regulate positions of the blocking apparatus and even take the blocking apparatus from the position of a heart defect; the present invention has the advantages of reasonable structure and conversion processing, and adopts silicone rubber as raw materials of surfaces of the blocking apparatus and a heart catheter; the surfaces of the blocking apparatus and the heart catheter are smooth and has good histocompatibility; the present invention is suitable for the cardiac atrium and ventricle septal defects with different sizes. The present invention is characterized in that the heart catheter connected with the blocking apparatus implants the blocking apparatus to the position of the cardiac atrium and ventricular septal defect. The present invention has the advantages of safety, convenient operation and low cost.
Description
Technical field
The present invention relates to the medical apparatus and instruments in a kind of implant into body heart, be specifically related to a kind of heart room, ventricular septal defect.
Background technology
Heart room, ventricular septal defect (ASD, VSD) are a kind of common congenital heart diseases, and the characteristics of pathological changes are that normally closed is failed at the interval between the heart of the left and right sides, and sickness rate accounts for 40% of congenital heart disease.Because under the normal condition, the pressure of the left heart is higher than the right heart, the damaged burden of heart that causes increases, and pulmonary circulatory blood volume increases, and finally can cause pulmonary hypertension, arrhythmia and heart failure.Mainly be to repair treatment in the past by surgical operation.King in 1974 and Mills use first and non-ly open breast ruling by law and treat II pass ASD, afterwards, are developed rapidly through conduit interventional therapy heart room, ventricular septal defect.
Main apparatus through vessel occlusion heart room, ventricular septal defect is a kind of utensil that is used for closed room, ventricular septal defect, is called stopper.Stopper is dual disc, sends into the heart defect position through cardiac catheter, reverts to design shape after conduit is released, and is clipped in damaged heart room, interventricular septum both sides, makes damaged closure, reaches the purpose of healing.The stopper that successively occurred has: the two-sided umbrella of Rashkind, button stopper, Angel-Wing stopper, ASDOS, CardioSEAL etc., and Amplatzer stopper commonly used now, its indication progressively enlarges, and makes transcatheter therapy ASD more perfect.Expanded to the ventricular septal defect treatment at present.The material that present stopper is selected for use is mainly made skeleton by medical stainless steel, and Nitinol is weaved into net, built-in terylene (or polyurethane sponge etc.) as bluff body.
The type position of heart room, ventricular 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 3mm, heart room, ventricular septal defect are not of uniform size, form is also irregular, needs stopper that the model of different-diameter is arranged, to be fit to the septal defects of different sizes.Heart should be able to be fixed on the septal defect place beating of not stopping after stopper puts in place reliably, and is easy to control, can conveniently withdraw from external when big ting model is improper.Because heart room, ventricular septal defect patient mostly are the child, blood vessel is thinner, and the delivery sheath that inserts endovascular importing stopper can not be greater than peripheral vascular diameter.Therefore, the selection of the adjustment of the selection of stopper materials, volume size, conduit diameter is the basis principle of stopper design and making.Once more, the stopper surface should be smooth smooth, selects suitable material stopper, makes its surface be difficult for forming thrombosis.
This area discloses heart room, ventricular septal defect that number of different types, different materials are made.For example (applying date: February 6 nineteen ninety-five) disclose a kind of dumbbell shaped atrial septal defect plugging device of being made by the biodegradable polymer material that can harden, the polymeric material of selecting for use can be foam plastics, rubber or sponge-like material to U.S.'s patent of invention US5634936.This stopper by changing pH, ionic strength, solvent or passing through irradiation infrared light, visible light or ultraviolet light etc., can make original softish polymer sclerosis after conduit is implanted the atrial septal defect position, revert to the dumbbell shaped of design.Stopper recovers shape play plugging effect after, the conduit that is connected with stopper breaks away from stopper, this U.S.'s patent of invention only introduces that the position through autofrettage breaks away from stopper on the conduit, but the concrete method of disengaging of introduction.
U.S.'s patent of invention US4836204B1 (applying date: on July 6th, 1987) disclose a kind of heart occluder for example, by two independently utricule form, the gap is left in the centre, can only play the effect of interim shutoff, can not really play the purpose of permanent shutoff heart room, ventricular septal defect.
U.S.'s patent of invention US6241678B1 (applying date: on August 21st, 1998) disclose a kind of detection sacculus of measuring the heart defect size for example again.Because this invention is a kind of detection sacculus, but not heart room, ventricular septal defect, its sacculus global shape is cylindrical, can not meet the purpose of the long-term shutoff of heart, can only play the effect of provisional detection heart room, ventricular septal defect size.
Heart room, ventricular septal defect that the disclosed number of different types in this area, different materials are made, still have the following disadvantages: the stopper of metal net shaped structure may damage normal cardiac tissue, and costs an arm and a leg; Stopper may cause the dystopy thromboembolism after meeting accident and dislocating; Stopper is difficult to reclaim behind shutoff heart room, ventricular septal defect; Because shutoff heart room, ventricular septal defect are incomplete, still may have residual shunt in various degree.
Summary of the invention
The purpose of this invention is to provide a kind ofly can not cause the dystopy thromboembolism because of coming off of stopper, can adjust repeatedly the stopper position in addition with stopper withdraw from from the heart defect position, safe and reliable, easy to make, rational in infrastructure, surface smoothing, cheap, be suitable for heart room, the ventricular septal defect of different sizes, it is characterized in that: the permanent heart occluder that is placed in intravital heart room, ventricular septal defect position, be made up of stopper main body and cardiac catheter, stopper main body and cardiac catheter are connected as a single entity.
For this reason, the invention provides a kind of through vessel occlusion heart room, ventricular septal defect.This stopper is symmetric dumbbell shape, make the stopper of hollow by silicone rubber, send into the position of heart room, ventricular septal defect through the heart conduit, after releasing in the conduit, inject medically acceptable liquid, make stopper full through conduit, ride in damaged heart room, ventricular septal defect both sides, make damaged closure, it is damaged to reach shutoff, thus the purpose of curing.In addition, inject the medically conduit of acceptable liquid, need not to take out.
A kind of heart provided by the invention room, ventricular septal defect are the Hollow dumb-bell shape air bag that silicone rubber is made, it mainly comprises in opposite directions thirty years of age the left cartridge sheet of stopper and the right cartridge sheet of stopper, the waist of stopper that connects the right cartridge sheet of the left cartridge sheet of above-mentioned stopper and stopper, and be positioned at stopper one end and the fixed connecting part that described right cartridge sheet links to each other, on described fixed connecting part, there is the duct of connection can inject medically acceptable liquid; Wherein, the left cartridge sheet of described stopper and the right cartridge sheet of stopper be according to the concrete condition of room, ventricular septal defect, with can remedy the room fully, ventricular septal defect gets final product, its shape can be a symmetrical structure, perhaps unsymmetric structure is beneficial to individualized treatment.
Described medically acceptable fill liquid is: normal saline, D/W, the body interimage agent of medically using, medically be applicable in the intravital liquid of people any.
The charging quantity of described medically acceptable fill liquid, full can make stopper, the purpose that reaches shutoff gets final product.
Described cardiac catheter is: in single chamber cardiac catheter, the two-chamber cardiac catheter any.
The length of described cardiac catheter is inserted the patient position according to stopper, and patient's age reserves suitable length, and conduit have certain elasticity with can satisfy hang down the age patient from now on because of growth promoter, grow tall after, the demand of the variation of internal organs distance.
Described stopper adopts binding agent to be connected with cardiac catheter.
Described stopper adopts blocking under warming to be connected with cardiac catheter.
Described stopper and cardiac catheter adopt other to reach to be connected and the method for sealing effectiveness connects.
The method for blocking of single chamber cardiac catheter, the method for blocking that is applicable to atrial septal defect is specific as follows: the stopper that will link to each other with single chamber cardiac catheter is by pushing steel wire, send in the long sheath pipe, through delivery sheath stopper is pushed to left atrium by pushing steel wire, down auxiliary at medical fluoroscopic apparatus: ultrasonic, X line perspective is the location down, the control stopper places defect, from the cardiac catheter of single chamber, inject medically acceptable fill liquid, make the room, ventricular septal defect is full, left and right sides dumbbell shaped air bag opens, be clipped in the room, the both sides of ventricular septal defect, sealing duct one end is embedded in subcutaneous.
The method for blocking of two-chamber cardiac catheter, the method for blocking that is applicable to ventricular septal defect is specific as follows: set up tremulous pulse-ventricular septal defect-vein track steel wire earlier, the two-chamber stopper that will link to each other with cardiac catheter, send into through peripheral blood vessel, when sending into, find time in the chamber from two-chamber, to guarantee that stopper can arrive the ventricular septal defect position smoothly, down auxiliary at medical fluoroscopic apparatus: ultrasonic, X line perspective is the location down, the control stopper places defect, injects medically acceptable fill liquid in the stopper, makes the room, ventricular septal defect is full, left and right sides dumbbell shaped air bag opens, and is clipped in the room, the both sides of ventricular septal defect.
Silicone rubber is all adopted on room, ventricular septal defect and the cardiac catheter surface of implanting, and histocompatibility is good, helps epithelization to form after the implantation, avoids producing the complication of thrombosis.
Below, the present invention is further illustrated with embodiment in conjunction with the accompanying drawings.
Fig. 1 is the atrial septal defect sketch map.
Fig. 2 is the ventricular septal defect sketch map.
Fig. 3 is the perspective view of stopper provided by the invention.
Fig. 4 fills medically acceptable filling liquid for stopper provided by the invention is placed the atrial septal defect sketch map.
Fig. 5 fills medically acceptable filling liquid for stopper provided by the invention is placed the ventricular septal defect sketch map.
Fig. 6 is for to place the atrial septal defect sketch map with stopper provided by the invention, full medically acceptable filling liquid, and the certain-length that cardiac catheter has been reserved.
Fig. 7 is for to place the ventricular septal defect sketch map with stopper provided by the invention, full medically acceptable filling liquid, and the certain-length that cardiac catheter has been reserved.
Embodiment and zoopery part
For making of the present invention, enforcement clearly are described, the manufacture method and the zoopery embodiment of following stopper is provided, but anything but in order to limit the present invention.
Stopper is made:
Make the dumbbell shaped mould with stainless steel material, get final product, can make the stopper of different size as required cooperating with room, ventricular septal defect.
Two-component silicone rubber mold on this stainless steel mould, 140 degree bakings are 8～10 hours in the constant temperature roaster, the demoulding.
Surfacing is the single chamber or the two-chamber cardiac catheter of silicone rubber, with binding agent or blocking under warming mode stopper is fixed on conduit one end.Determine damaged size with the sacculus Detection Techniques, implement operation plan by single chamber cardiac catheter or two-chamber cardiac catheter respectively.
Concrete zoopery embodiment is as follows:
The first step: ASD modelling.
14 mongrels, male and female are regardless of, 6 female 8 heros, body weight 15～30Kg, average 24.2Kg.
Vein sodium phenobarbital 30mg/Kg anesthesia, tracheal intubation, left lateral position carries out under aseptic condition, right 4～5 intercostal incisions, successively separate skin is cut pericardium, exposes heart.No wound line is made annular pocket on right atrium, the about 15mm of annular diameter, the operator right hand is held auricle clamp, the right atrium otch of left index finger through cutting directly disclosed out fossa ovalis through going into right atrium with left index finger, forms the about 8mm～10mmASD of diameter, sew up right atrium and pericardium, successively close breast, skin suture is put thoracic cavity and drainage of pericardium pipe and was pulled out in 6 hours.
Carry out the experiment of shutoff ASD after 2 weeks.
Second step: the ASD stopper is made.
1, make the dumbbell shaped mould with stainless steel material, two ends are rounded, diameter 16mm, mid diameter 12mm, length 12mm (as shown in Figure 3).
2, two-component silicone rubber (Shanghai medical grade silicon rubber institute provides) mold.Toast in the constant temperature roaster, dumbbell shaped silicone rubber stopper is made in the demoulding.
3, the bi-lumen cardiac catheter stomidium can hold 0.035 seal wire and passes through, and dumbbell shaped silicone rubber stopper is fixed on bi-lumen cardiac catheter one end, can arbitrarily pass through conduit from the cardiac catheter other end, injects liquid or extract liquid out in stopper.
The 3rd step: shutoff ASD process.
The shutoff process is carried out under x-ray fluoroscopy, the vein general anesthesia, and right external jugular vein 12F venipuncture sheath, enters right room and enters left room by ASD under 0.035 steel wire guides with the JR4.0 right heart catheter, and the left room of row cardiografin radiography confirms that conduit is positioned at left room.Under steel wire guiding, stopper enters from right external jugular vein, prolongs steel wire and advances and ride that the room is damaged to be confirmed to put in place with the full stopper of cardiografin, withdraws from steel wire, and the external end of sealing duct is embedded in subcutaneous.
In 2 weeks, in 6 weeks, 12 weeks were put to death animal respectively, dissected heart, observed the situation of stopper and surrounding tissue.
The 4th step: zoopery result.
Successfully make 10 on ASD model in the damaged model of ASD, 14 animals.Because the defective of method, the patient cooperates unskilled with the assistant, hemorrhage more, adds that Animal Lab. does not have defibrillation device when beginning to test, after improve one's methods, success rate obviously improves.(4 animal dead reasons, quiver in a routine sudden cardiac arrest, a routine pulmonary consolidation, a routine internal hemorrhage, a routine chamber).
10 animals are successfully made the ASD model, survey ASD diameter 9mm through sacculus.Stopper all can enter right room from peripheral vein smoothly, rides on atrial septal defect under the X line guides.The slippage when isolation catheter of two examples, an example enters right pulmonary artery, and an example enters the right lower extremity tremulous pulse, and animals survived is put to death animal after two weeks, and postmortem confirms.Eight routine animal methods have improvement, and the decision conduit does not separate with stopper, all success.Both improved the safety of shutoff process, and made the whole operation process very convenient simple.Saved the process of isolation catheter and stopper again.
After the shutoff process was finished, different time was put to death 2 weeks of animal (4), 6 weeks (2), in 12 weeks (2), all stopper all rides in the interatrial septum, does not have thrombosis around the perusal stopper, have cellulose to cover around 6 all stoppers, cellulose is more on every side for stopper during 12 weeks.
Claims (7)
1. a heart room, ventricular septal defect is characterized in that: the permanent heart occluder that is placed in intravital heart room, ventricular septal defect position, to form by stopper main body and cardiac catheter, and stopper main body and cardiac catheter are connected as a single entity.
2. heart according to claim 1 room, ventricular septal defect, it is characterized in that: described stopper is the Hollow dumb-bell shape air bag that silicone rubber is made, after adopting the fill liquid that medically uses full, shape matches with heart room, ventricular septal defect.
3. heart according to claim 2 room, ventricular septal defect is characterized in that: described fill liquid is: in normal saline, the D/W any.
4. heart according to claim 1 room, ventricular septal defect is characterized in that: the cardiac catheter that described and stopper main body are connected as a single entity is: in single chamber cardiac catheter, the two-chamber cardiac catheter any.
5. heart according to claim 4 room, ventricular septal defect is characterized in that: described cardiac catheter length in reserve and flexible adapts to the low age patient from now on because the possible demand of variation of growth promoter, internal organs distance.
6. heart according to claim 1 room, ventricular septal defect is characterized in that: stopper adopts binding agent to be connected with cardiac catheter.
7. heart according to claim 1 room, ventricular septal defect is characterized in that: stopper adopts the method for blocking under warming to be connected with cardiac catheter.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100673525A CN100396246C (en) | 2004-10-21 | 2004-10-21 | Blockage for septal defect between cardiac atrium and ventricle |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100673525A CN100396246C (en) | 2004-10-21 | 2004-10-21 | Blockage for septal defect between cardiac atrium and ventricle |
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| Publication Number | Publication Date |
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| CN1600276A CN1600276A (en) | 2005-03-30 |
| CN100396246C true CN100396246C (en) | 2008-06-25 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB2004100673525A Expired - Fee Related CN100396246C (en) | 2004-10-21 | 2004-10-21 | Blockage for septal defect between cardiac atrium and ventricle |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102805673A (en) * | 2012-08-15 | 2012-12-05 | 上海形状记忆合金材料有限公司 | Occluder |
| CN103462653A (en) * | 2013-08-30 | 2013-12-25 | 上海市东方医院 | Intervening and closuring partitioning catheter for congenital heart disease ventricular septal defect surgery |
| US20180333150A1 (en) * | 2017-05-16 | 2018-11-22 | Edwards Lifesciences Corporation | Trans-septal closure device |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4836204A (en) * | 1987-07-06 | 1989-06-06 | Landymore Roderick W | Method for effecting closure of a perforation in the septum of the heart |
| US5634936A (en) * | 1995-02-06 | 1997-06-03 | Scimed Life Systems, Inc. | Device for closing a septal defect |
| CN2430113Y (en) * | 2000-08-28 | 2001-05-16 | 曾国洪 | Disposable abnormal path block device in heart and blood vessel |
| US6241678B1 (en) * | 1998-08-21 | 2001-06-05 | Aga Medical Corporation | Sizing catheter for measuring septal defects |
-
2004
- 2004-10-21 CN CNB2004100673525A patent/CN100396246C/en not_active Expired - Fee Related
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4836204A (en) * | 1987-07-06 | 1989-06-06 | Landymore Roderick W | Method for effecting closure of a perforation in the septum of the heart |
| US5634936A (en) * | 1995-02-06 | 1997-06-03 | Scimed Life Systems, Inc. | Device for closing a septal defect |
| US6241678B1 (en) * | 1998-08-21 | 2001-06-05 | Aga Medical Corporation | Sizing catheter for measuring septal defects |
| CN2430113Y (en) * | 2000-08-28 | 2001-05-16 | 曾国洪 | Disposable abnormal path block device in heart and blood vessel |
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| CN1600276A (en) | 2005-03-30 |
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