CN104173122A - Plugging device suitable for postoperation perivalvular leakage - Google Patents
Plugging device suitable for postoperation perivalvular leakage Download PDFInfo
- Publication number
- CN104173122A CN104173122A CN201410461011.XA CN201410461011A CN104173122A CN 104173122 A CN104173122 A CN 104173122A CN 201410461011 A CN201410461011 A CN 201410461011A CN 104173122 A CN104173122 A CN 104173122A
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- Prior art keywords
- area elliptica
- area
- stopper
- elliptica
- perivalvular leakage
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Abstract
The invention provides a plugging device suitable for postoperation perivalvular leakage. The plugging device comprises a fabric body and films. The fabric body is formed by a first oval area, a second oval area and a third oval area in the middle, wherein the first oval area and the second oval area are arranged on the two sides. The third oval area is shaped like a hollow oval cylinder with the ratio of a long axis to a short axis ranging from one third to two thirds. The fact that a mechanical valvula suture ring of the portion to be plugged is clamped can be used as a criterion for the thickness of the third oval area. The portion extends outwards by 0.2 mm-1 mm from the outer edge of the third oval area to form the edge of the second oval area. At least one unfolded film is arranged in a cavity in the third oval area. When the plugging device is used for plugging, the oval plugging device is arranged along a leakage point and has the deformation and self-adaptation features, after the plugging device is plugged into the leakage point, the self-adaptive deformation is generated, the leakage point is plugged completely, tension is proper, and the plugging device is more suitable for the interventional therapy of the perivalvular leakage.
Description
Technical field
This scheme relates to stopper conventional in a kind of intervene operation, specifically a kind of special-purpose stopper that is applicable to postoperative perivalvular leakage.
Background technology
Mechanical prosthetic valve is the artificial valve who makes with non-biological material, and basic structure comprises lobe frame, valve body, suture ring three parts, by its structure and shape, is divided into caged ball valve, tilt disc prosthesis and bilobed flap.In the cage that caged ball valve is cast by rustless steel, inlay the spheroid that a silicone rubber is made, move up and down to form close and open by spheroid in cage, lobe mouth blood flow is peripheral.Tilt disc prosthesis lobe frame is made by alloy or RESEARCH OF PYROCARBON, and video disc is RESEARCH OF PYROCARBON material, with metallic bond, video disc is hanged and is sandwiched in circular lobe frame, and limb is at open time image lopsidedness, and lobe mouth blood flow is half centre type.Bilobed flap lobe frame is made by RESEARCH OF PYROCARBON, and two semicircle lamellar lobe leaf mosaics of being made by RESEARCH OF PYROCARBON are in lobe frame, and limb is like two fan doors, and its switch produces opening and cutting out of lobe, and lobe mouth blood flow is centre type, and pressure gradient is little.The mechanical prosthetic valve of above-mentioned three kinds of structures is all generally that the mode by sewing up is sewn to heart or Supraaortic.
Periprosthetic leakage after cardiac valve replacement (PVL) is the postoperative distinctive complication of valve replacement.According to the incidence rate approximately 3～12.5% of foreign literature report perivalvular leakage, wherein Bicuspid valve perivalvular leakage incidence rate is apparently higher than aortic valve.PVL occurrence cause is more, and generally appears at perform the operation early stage or late period.
Therapeutic Method for perivalvular leakage has at present: modus operandi and intervention method, the special-purpose stopper that does not wherein carry out shutoff for this operation specially, in clinical, routine is that what to be used is patend ductus arteriosus occluder or ventricular septal defect, the agent structure formula of above-mentioned stopper is columniform, directly bring that to be applied in perivalvular leakage operation be inappropriate, because using this stopper to carry out in the process of shutoff, position and the shape of this stopper and perivalvular leakage misfit, there is very poor conformability, after carrying out shutoff, also likely occur biasing phenomenon.For adapting to the shape of perivalvular leakage leak, the distortion of stopper is larger, causes the overtension for suture site, forms new leakage point simultaneously, so and is not suitable in the treatment of perivalvular leakage.
Current according to applicant's understanding, not carry out shutoff use for perivalvular leakage specially special-purpose stopper.
Summary of the invention
For above problem, a kind of stopper that is applicable to postoperative perivalvular leakage is provided, first, for the feature of postoperative perivalvular leakage, research and develop the special-purpose stopper of design, there is obvious advantage, secondly, have better applicable performance, postoperative life-span and conformability are better, and the 3rd, based on existing forming technique, be easy to manufacture and produce.
The technical solution adopted for the present invention to solve the technical problems is:
Be applicable to a stopper for postoperative perivalvular leakage, comprise knitted body and thin film, described knitted body is with thin tinsel through braiding and setting process one-shot forming, and described thin film is medical macromolecule membrane, it is characterized in that,
Described knitted body is that whole the first area elliptica by both sides, the second area elliptica and the 3rd middle area elliptica that is column forms, and the size aspect of described the first area elliptica should meet, 1.5 millimeters to the 2 millimeters edges that form described the first area elliptica stretch out from the outer of the 3rd area elliptica;
Described the 3rd area elliptica, for the ratio of major axis and minor axis is the oval tubular of a hollow between 1/3rd to 2/3rds, and and seamlessly transit and continued presence between first, second area elliptica of both sides, on thickness direction, the thickness of described the 3rd area elliptica treats that to block the mechanical prosthetic valve suture ring of shutoff place is as the criterion;
The second area elliptica, the size aspect of described the second area elliptica should meet, and 0.2 millimeter to 1 millimeter edge that forms described the second area elliptica stretches out from the outer of the 3rd area elliptica;
Closing in place of described knitted body lays respectively at described the first area elliptica or/and the centre of the second area elliptica, and by the mode of extrusion modling or welding fabrication, fixes a threaded threaded column of tool in described the second area elliptica closing in place;
The thin film of at least one expansion is set in described the 3rd area elliptica internal cavities, and the surrounding of each thin film and knitted body are sewed up and are connected to form one.
Further, at described the second area elliptica, along the two ends of long axis direction, be respectively arranged with a gold markers point or platinum gauge point.
Further, described thin film is high-molecular polyvinyl alcohol thin film or macromolecule silica gel thin film conventional in medical treatment.
Further, the closing in being positioned on described the second area elliptica caves inward, and described threaded column is arranged on
In depression.
Further, on thickness direction, the thickness of described the 3rd area elliptica is between 3 millimeters to 4 millimeters.
Further, described threaded column is the alloy body identical with knitted body material, and described threaded column is trapped in the inside of whole stopper in being, with guarantee outer surface be one level and smooth, reduce thrombotic probability.
Further, the tinsel that described knitted body is used will have the alloy threadlet of memory function for nitinol or other.
The invention has the beneficial effects as follows: because the shape of perivalvular leakage is generally irregular ") " crescent shape, when using this stopper to carry out shutoff, elliptoid stopper is arranged along leak source, and elliptoid stopper has distortion, adaptive characteristic, after being filled in leak source, can carry out adaptive distortion, leak source is blocked completely, and tension force is suitable, is more suitable for the insertion type treatment in perivalvular leakage.
Accompanying drawing explanation
Fig. 1 is illustraton of model of the present invention.
Fig. 2 is the front view of Fig. 1.
Fig. 3 is the upward view of Fig. 2.
Fig. 4 is A--A cutaway view in Fig. 2.
Fig. 5 is the schematic diagram of mechanical prosthetic valve perivalvular leakage.
Fig. 6 is the effect schematic diagram of the present invention to perivalvular leakage shutoff.
Fig. 7 is three-dimensional full-page proof of the present invention.
In figure: 1 stopper, 1 ' knitted body, 11 first area ellipticas, 12 second area ellipticas, 13 the 3rd area ellipticas, 14 threaded column, 2 mechanical prosthetic valves, 3 locular walls, 41 the first film sheets, 42 second diaphragms, 5 gauge points, 6 leak sources.
The specific embodiment
As shown in Figures 1 to 7, the present invention relates to a kind of stopper that is applicable to postoperative perivalvular leakage, this stopper is comprised of filament, impermeable thin film and retaining element.
For existing defect, the protection main body of this patent is as follows:
What develop is a kind of medical element that carries out shutoff for the postoperative perivalvular leakage disease of mechanical prosthetic valve.This element makes shutoff process be full of flexibility by the damage of minimum level and the interventional method of minimum level, the physiological structure of analysing that more meets mechanical prosthetic valve and suture site on this component structure, and accomplish and the coincideing of leak source position as far as possible, in the situation that not reducing bond strength, make the position, accurate arrival closure part that this element can be complete, and make tension force best, implement shutoff, and the effect of shutoff and the life-span of use there is obvious increase.
Whole design idea is that its shape is designed to ellipse, to reduce the expansionary force for leak source, its basic principle is, stopper 1 is compressed and imported to and needed the perivalvular leakage of shutoff leak source position by conduit, make gauge point 5 just in time face toward the binding site of leak source 6 both sides, then stopper is derived in conduit, because stopper has shape memory function, can restore to the original state, and both sides are stuck in leak source both sides, block and be fixed on leak source, finally conduit and seal wire are extracted out, complete fixing, as shown in Figure 6, due to the shape of this stopper and the shape of leak source substantially identical, and the profile than leak source is bigger, after installation, by its tension force, just can realize fixing.
Description based on above-mentioned, this stopper is under hard-wired situation, make stopper can realize as much as possible the shutoff at leak source position, and be fitted in as much as possible tram, make particularly both to meet and to be installed with the object that meets complete shutoff due to tension force and elliptoid shape.
Stopper provided by the invention is a kind of stopper that is specifically designed to treatment perivalvular leakage simultaneously, is applicable to guide by conduit the stopper of controlling operation.
Owing to wanting the position of shutoff to be positioned between mechanical prosthetic valve 2 and locular wall 3 (or tube wall), and special shape and position have determined the requirement of this stopper.
The main body of this stopper 1 through weaving molding, is formed by 72 one metal wires braidings with thin tinsel, is a knitted body 1 ', the structural style (as Fig. 7) that can adopt two ends to close up, and by a special integral body of setting process formation.Here, above-mentioned tinsel, preferentially selects, for example nitinol or other are made the alloy material with memory function, have both had certain flexibility, can remove under the situation of external force again, automatically return to original state, rely on the tension force of himself that it is fixed.For meeting the requirement of operation, should there is sufficient flexibility.The alloy using due to this stopper has memory function, stopper in importing process in compression state, and import smoothly, after reaching precalculated position, discharge, after release, can be returned to timely predetermined shape.
From structure, the knitted body of this stopper partly comprises the first area elliptica 11, the second area elliptica 12 and the 3rd middle area elliptica 13 of both sides, the first area elliptica 11 size aspects should meet, from the outer of cylindrical area, stretch out 2 millimeters (L), referenced in schematic 2.
The 3rd area elliptica 13, for the ratio of major axis and minor axis is the oval tubular of a hollow between 1/3rd to 2/3rds, best, the ratio of major axis and minor axis is 1/2nd, and and seamlessly transit and continued presence between the area elliptica of both sides, can not occur sharp-pointed or there is discrete point, on thickness direction, the thickness H of the 3rd area elliptica 13 treats that to block the mechanical prosthetic valve suture ring of shutoff place is as the criterion, guarantee this thickness should be substantially and the thickness of aortic valve breakage adapt, avoid occurring that card is not tightly or too tight phenomenon.Can be made into a series, to meet the needs of different big or small leak sources, the breakage size of shutoff is selected as required.In strength character, this region has supports the own tension force that leak source shrinks, and the shape that remains unchanged for a long period of time, and described herein referring to for a long time take that year at age of people is unit.
The second area elliptica 12, and the size aspect of described the second area elliptica should meet, and from the outer of the 3rd area elliptica, stretch out 0.2 millimeter to 1 millimeter (M) forms the edge of described the second area elliptica, and best is 0.8 millimeter.
Three above-mentioned parts form by a setting process, and what in structure, be braiding is netted, and does not have discontinuous or sharp-pointed or uneven shape, should be and seamlessly transits.
In the second area elliptica 12 centre, it is closing in place, and the shape of a depression is done in this closing in place, and by the form of extrusion modling or welding, fix a threaded column 14 with helicitic texture at this recess, structure is similar with existing threaded column, and best, and this threaded column 14 is trapped in the inside of whole stopper in being, with guarantee outer surface be one level and smooth, more level and smooth in appearance, meanwhile, reduce thrombotic probability.
In using the process of metal wire knitted knitted body, different according to the selection schemer of technique, conventionally can form the pattern closing up in one end; The pattern that also can adopt two ends to close up is another closing-in structure of a knitted body in the center of described the first area elliptica.
In theory, the processing technology of two closing-in structures is more simple than single bottling technique.The knitted body of these two kinds of versions is all within protection scope of the present invention.
Then use and there is impermeable sheet film and block, concrete preparation two each and every one the size circular diaphragm suitable with the 3rd area elliptica area, be labeled as the first film sheet 41 and the second diaphragm 42, be separately positioned in the inner chamber of the 3rd area elliptica and the first area elliptica, this diaphragm adopts macromolecular material to be made, for example, conventional high-molecular polyvinyl alcohol thin film or macromolecule silica gel thin film material in medical treatment.This diaphragm is embedded in the cavity of the 3rd area elliptica, and launch fully, flatten, do not allow to occur the phenomenon of stack, fold, then use sewing process that the surrounding of thin film and the 3rd area elliptica are sewed up, form a partition-type structures, this sewing process should guarantee that the node of suture is as much as possible little, level and smooth.
At described the second area elliptica, along the two ends of long axis direction, be welded with respectively a gold markers point 5 or platinum gauge point, make to carry out when performing the operation position mark.By above-mentioned mode, form a stopper.
This stopper, knitted body forms a flexible skeleton with certain memory function, and thin film is the barrier film of occlude blood.And the given shape of knitted body meets the shutoff needs of interventricular septum specific part.
Embodiment recited above is described the preferred embodiment of the present invention; not scope of the present invention is limited; design under the prerequisite of spirit not departing from the present invention; relevant technical staff in the field, to various distortion of the present invention and improvement, all should expand in protection domain as determined in the claims in the present invention book.
Claims (7)
1. be applicable to a stopper for postoperative perivalvular leakage, comprise knitted body and thin film, described knitted body is with thin tinsel through braiding and setting process one-shot forming, and described thin film is medical macromolecule membrane, it is characterized in that,
Whole the 3rd area elliptica for first area elliptica by both sides of column, the second area elliptica and centre of described knitted body forms, and the size aspect of described the first area elliptica should meet, 1.5 millimeters to the 2 millimeters edges that form described the first area elliptica stretch out from the outer of the 3rd area elliptica;
Described the 3rd area elliptica, for the ratio of major axis and minor axis is the oval tubular of a hollow between 1/3rd to 2/3rds, and and seamlessly transit and continued presence between first, second area elliptica of both sides, on thickness direction, the thickness of described the 3rd area elliptica treats that to block the mechanical prosthetic valve suture ring of shutoff place is as the criterion;
The second area elliptica, the size aspect of described the second area elliptica should meet, and 0.2 millimeter to 1 millimeter edge that forms described the second area elliptica stretches out from the outer of the 3rd area elliptica;
Closing in place of described knitted body lays respectively at described the first area elliptica or/and the centre of the second area elliptica, and by the mode of extrusion modling or welding fabrication, fixes a threaded threaded column of tool in described the second area elliptica closing in place;
The thin film of at least one expansion is set in described the 3rd area elliptica internal cavities, and the surrounding of each thin film and knitted body are sewed up and are connected to form one.
2. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1, is characterized in that, at described the second area elliptica, along the two ends of long axis direction, is respectively arranged with a gold markers point or platinum gauge point.
3. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1 and 2, is characterized in that, described thin film is high-molecular polyvinyl alcohol thin film or macromolecule silica gel thin film conventional in medical treatment.
4. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 2, is characterized in that, the closing in being positioned on described the second area elliptica caves inward, and described threaded column is arranged in depression.
5. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 4, is characterized in that, described threaded column is the alloy body identical with knitted body material, and described threaded column is trapped in the inside of whole stopper in being.
6. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1, is characterized in that, on thickness direction, the thickness of described the 3rd area elliptica is between 3 millimeters to 4 millimeters.
7. a kind of stopper that is applicable to postoperative perivalvular leakage according to claim 1, is characterized in that, the tinsel that described knitted body is used will have the alloy threadlet of memory function for nitinol or other.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410461011.XA CN104173122A (en) | 2014-09-11 | 2014-09-11 | Plugging device suitable for postoperation perivalvular leakage |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410461011.XA CN104173122A (en) | 2014-09-11 | 2014-09-11 | Plugging device suitable for postoperation perivalvular leakage |
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| CN104173122A true CN104173122A (en) | 2014-12-03 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201410461011.XA Pending CN104173122A (en) | 2014-09-11 | 2014-09-11 | Plugging device suitable for postoperation perivalvular leakage |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106983528A (en) * | 2017-04-27 | 2017-07-28 | 广州启骏生物科技有限公司 | A kind of perivalvular leakage plugging device |
| CN108125733A (en) * | 2018-02-11 | 2018-06-08 | 四川中盾知识产权服务有限公司 | A kind of heart valve tricuspid annulus |
| CN112022234A (en) * | 2019-05-17 | 2020-12-04 | 先健科技(深圳)有限公司 | Implantable device and preparation method thereof |
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| US5904703A (en) * | 1996-05-08 | 1999-05-18 | Bard Connaught | Occluder device formed from an open cell foam material |
| CN1283973A (en) * | 1998-02-06 | 2001-02-14 | Aga医药有限公司 | Percutaneous catheter directed constricting occlusion device |
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|---|---|---|---|---|
| CN106983528A (en) * | 2017-04-27 | 2017-07-28 | 广州启骏生物科技有限公司 | A kind of perivalvular leakage plugging device |
| CN108125733A (en) * | 2018-02-11 | 2018-06-08 | 四川中盾知识产权服务有限公司 | A kind of heart valve tricuspid annulus |
| CN112022234A (en) * | 2019-05-17 | 2020-12-04 | 先健科技(深圳)有限公司 | Implantable device and preparation method thereof |
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Application publication date: 20141203 |