CN211355625U - Single-disc type ventricular septal defect plugging device - Google Patents

Abstract

The utility model provides a single-disk ventricular septal defect occluder, including being the tubulose and being used for fixing the waist in ventricular septal defect department, the waist only is connected with at its distal end that is located left ventricle side and is the discoid disc, the inside of waist and the inside of disc all are fixed with the blood flow barrier film, the barb has set firmly on the side of disc orientation waist. The disc is arranged at the far end of the waist part on the left ventricle side, the anchoring effect is improved through the barbs on the disc, the disc is not arranged at the near end of the waist part on the right ventricle side, and therefore the clamping and anchoring characteristics of the ventricular septal defect plugging device with the double-disc structure in the prior art are cancelled, complications such as atrioventricular conduction block and the like caused by too high force of clamping the atrial septal gap by the ventricular septal defect plugging device are effectively reduced through the single-disc structure, meanwhile, the disc is prevented from being worn by endocardial tissues such as tricuspid key cables on the right ventricle surface in the process that the disc jumps along with the heart, and the complications caused by the ventricular septal defect plugging device are further reduced.

Description

Single-disc type ventricular septal defect plugging device

Technical Field

The utility model relates to a medical instrument, in particular to a single-disc type ventricular septal defect occluder.

Background

Ventricular Septal Defect (VSD) refers to the presence of an opening in the Ventricular septum, which can be located anywhere in the Ventricular septum and divided into different anatomical types; VSDs vary in size and may be unigenic (simple VSDs) or incorporate other intracardiac and extracardiac abnormalities (complex VSDs). Its formation can be acquired from congenital causes or acquired causes, such as post-traumatic or myocardial infarction VSD. Simple VSD is the most common cardiac malformation, with an incidence of about 2% o, accounting for 20% of all congenital heart diseases; such as VSDs, including those incorporating other malformations, will exceed 50% of all congenital heart diseases.

Cardiac surgery has been using open-chest patch therapy to treat VSDs for over 50 years and has been considered the preferred, or even the only, method of treating VSDs of all types. However, the trauma of the surgical operation is large, extracorporeal circulation support is required, complications and complications are increased, and the operation difficulty is increased due to the damage of normal anatomical physiological structures in the complex congenital heart disease requiring the secondary operation.

After the 80 s in the 20 th century, percutaneous ventricular septal defect occlusion became a mature treatment for interventional heart disease, and is currently an important treatment for ventricular septal defect. The ventricular septal defect occluder is the indispensable medical instrument for treating the Ventricular Septal Defect (VSD).

The existing ventricular septal defect occluder is in a double-disc structure, such as an atrial septal defect occluder disclosed in the chinese patent application with the application number of 201811238760.0, and such as an ventricular septal defect occluder disclosed in the chinese utility model with the application number of 201621313690.7. The ventricular septal defect occluder with the double-disc structure is provided with two discs and a columnar waist connected between the two discs, the diameter of the waist must be matched with the diameter of a defect, so that the ventricular septal defect occluder is fixed at the defect and is not easy to shift and fall off, the two discs must be respectively placed in the left atrium and the right atrium to form clamping with large force, and the ventricular septal defect occluder and the heart can jump cooperatively to reduce the occurrence rate of residual shunt.

However, since the ventricular septal defect is located very close to the aortic valve and the electrical conduction system controlling the heart to beat, the occlusion position of the ventricular septal defect occluder with the double-disk structure after implantation affects the intracardiac tissue, and the common complications are as follows:

1. arrhythmia, which is serious three-degree atrioventricular block, is caused by damage to a conduction system due to excessive clamping force between two disks of the ventricular septal defect occluder;

2. residual shunting, the occurrence factor of which is related to the selection of too small or displacement of the ventricular septal defect occluder;

3. the valvular insufficiency is a cause of chordae tendineae breakage caused by abrasion of the disc surface of the ventricular septal defect occluder on the chordae tendineae of the tricuspid valve, the tricuspid valve consists of a septal valve, a posterior valve and an anterior valve, wherein the anterior valve is the largest and is the main part for completing the normal closure of the tricuspid valve; if the damaged chordae tendineae are small, there may be only a small amount of regurgitation, and if the damaged chordae tendineae are large, particularly the chordae tendineae of the anterior valve, there may be a large amount of regurgitation in the tricuspid valve that must be repaired using open-chest, open-vision surgery.

The above complications can bring serious consequences of heart damage and even life threatening.

SUMMERY OF THE UTILITY MODEL

In view of the above shortcomings of the prior art, the to-be-solved technical problem of the present invention is to provide a single-disk ventricular septal defect occluder, which is more conformable to the human body characteristics and reduces complications.

In order to realize above-mentioned purpose, the utility model provides a single-disk ventricular septal defect occluder, including being the tubulose and being used for fixing the waist in ventricular septal defect department, the waist only is connected with at its distal end that is located the left ventricle side and is the discoid disc, the inside of waist and the inside of disc all are fixed with blood flow barrier membrane, the disc has set firmly the barb on the side of waist towards.

Further, be one-piece spare between waist and the disc, be one-piece spare between disc and the barb.

Further, the waist and the disc each comprise a plurality of elastic wires woven together.

Furthermore, the elastic metal wire is provided with a flat part which is locally flattened, and the barb is formed by laser engraving of the flat part.

Furthermore, a carving groove is formed in the flat part after laser carving, the inner end of the barb is connected with the near end of the carving groove, and the outer end of the barb faces the near end of the single-disc ventricular septal defect occluder.

Further, the elastic metal wire is a nickel-titanium alloy metal wire.

Furthermore, the single-disc ventricular septal defect occluder further comprises a near-end gathering point and a far-end gathering point, the ends of the elastic metal wires for weaving the waist are restrained and fixed by the near-end gathering point, and the ends of the elastic metal wires for weaving the disc are restrained and fixed by the far-end gathering point.

Further, the barb is arc-shaped, and the opening of the barb faces to the near end of the single-disc ventricular septal defect occluder.

As mentioned above, the utility model relates to a single-disk type ventricular septal defect occluder has following beneficial effect:

the single-disc ventricular septal defect occluder is fixed at the ventricular septal defect through barbs on the waist, the disc and the disc, so that the single-disc ventricular septal defect occluder is not easy to shift. In particular, since the pressure of the left ventricular blood is much greater than that of the right ventricular blood, the disc is arranged at the far end of the waist part on the left ventricular side, the anchoring effect is increased through the barbs on the disc, and the disc is not arranged at the near end of the waist part on the right ventricular side, so that the clamping and anchoring characteristics of the ventricular septal defect occluder with a double-disc structure in the prior art are eliminated. Based on this, this application effectively reduces complications such as atrioventricular conduction block that the dynamics that the heart septal defect plugging device presss from both sides the atrial septum is too big because of single disc structure, eliminates the disc simultaneously and beats the in-process along with the heart, and the disc is to the wearing and tearing of the intracardiac tissue such as right ventricle face tricuspid valve key cable, further reduces the complications that the ventricular septal defect plugging device brought. Therefore, the utility model relates to a single-disk ventricular septal defect occluder laminates the human body characteristic more, effectively reduces the complication.

Drawings

Fig. 1 is a structural schematic diagram of a single-disc type ventricular septal defect occluder in the application.

Fig. 2 is a front view of fig. 1.

Fig. 3 is a side view of fig. 1.

Fig. 4 is a view showing the connection between the barbs and the elastic wire at the position of the circle a in fig. 2.

Description of the element reference numerals

1 waist part

2 disc

3 barbs

4 elastic wire

41 flat part

42 carving groove

5 near-end rendezvous Point

6 remote aggregation point

Detailed Description

The following description is provided for illustrative purposes, and other advantages and features of the present invention will become apparent to those skilled in the art from the following detailed description.

It should be understood that the drawings of the present application are only used to match the contents disclosed in the specification, so as to be known and read by those skilled in the art, and not to limit the practical limitations of the present invention, so that the present application does not have any technical significance, and any modification of the structure, change of the ratio relationship, or adjustment of the size should still fall within the scope of the present application without affecting the function and the achievable purpose of the present application. Meanwhile, the terms such as "upper", "lower", "left", "right", "middle", and the like used in the present specification are for convenience of description, and are not intended to limit the scope of the present invention, and changes or adjustments of the relative relationship thereof may be considered as the scope of the present invention without substantial changes in the technical content.

As shown in fig. 1 to 3, the present invention provides a single-disc ventricular septal defect occluder, which comprises atubular waist portion 1 for being fixed at the ventricular septal defect, wherein thewaist portion 1 has a proximal end and a distal end, the proximal end is the end of thewaist portion 1 close to the operator and is also the right end of the view shown in fig. 2, and the distal end is the end of thewaist portion 1 away from the operator and is also the left end of the view shown in fig. 2; meanwhile, the proximal end of thewaist portion 1 also refers to the end of thewaist portion 1 located on the right atrium side, and the distal end of thewaist portion 1 also refers to the end of thewaist portion 1 located on the left atrium side. Specifically, as shown in fig. 1 to 3, thewaist portion 1 of the single disc type ventricular septal defect occluder is connected with adisc 2 in a disc shape only at the far end thereof located at the left ventricle side, the outer diameter of thedisc 2 is larger than that of thewaist portion 1, a blood flow blocking membrane for blocking blood flow is fixed in both the inside of thewaist portion 1 and the inside of thedisc 2, andbarbs 3 are fixed on the side surface of thedisc 2 facing the near end side of thewaist portion 1, so that thebarbs 3 are located at the side surface where thedisc 2 is connected with thewaist portion 1.

The single-disc ventricular septal defect occluder is implanted at a ventricular septal defect through the conveying device, and after the single-disc ventricular septal defect occluder is implanted, thewaist part 1 is fixed in the ventricular septal defect, so that the single-disc ventricular septal defect occluder is not easy to shift, and residual shunt is reduced; the near end of thewaist part 1 is positioned in the right ventricle, and thedisc 2 at the far end of thewaist part 1 is positioned in the left ventricle; thebarbs 3 are anchored into the surface of the ventricular septal defect, and the single-disc ventricular septal defect occluder is fixed at the ventricular septal defect part through thewaist 1, thedisc 2 and thebarbs 3 on thedisc 2, so that the single-disc ventricular septal defect occluder is not easy to shift. Particularly, as the pressure of the left ventricular blood is far greater than that of the right ventricular blood, thedisc 2 is arranged at the far end of thewaist 1 on the left ventricular side, the anchoring effect is improved through thebarbs 3 on thedisc 2, the ventricular septal defect occluder is anchored at the surface position of the ventricular septal defect through thebarbs 3, the single-disc ventricular septal defect occluder can be prevented from falling off, the single-disc ventricular septal defect occluder can be cooperated with the heartbeat, and the single-disc ventricular septal defect occluder is not transplanted into the position under the impact of blood flow, so that the occlusion effect of the ventricular septal defect is ensured. Further, the proximal end of thewaist 1 on the right ventricular side in the present application is not provided with thedisc 2, thereby eliminating the clamping anchoring property of the ventricular septal defect occluder of the prior art double-disc structure. Based on this, this application effectively reduces complication such as atrioventricular conduction block that the dynamics that the heart septal defect plugging device presss from both sides the atrial septum is too big because ofsingle disc 2 structure, eliminatesdisc 2 along with the heart in-process simultaneously, anddisc 2 is to the wearing and tearing of the intracardiac tissue such as right ventricle face tricuspid valve key cable, further reduces the complication that ventricular defect plugging device brought. Therefore, the utility model relates to a single-disk ventricular septal defect occluder laminates the human body characteristic more, effectively reduces the complication.

As shown in fig. 1 to 3, the number of thebarbs 3 provided on thedisk 2 is 2 or more, ensuring an anchoring effect. In addition, thewaist portion 1 and thedisk 2 are woven by a plurality ofelastic metal wires 4, so that both thewaist portion 1 and thedisk 2 include a plurality ofelastic metal wires 4 woven together, and thebarbs 3 integrally extend from theelastic metal wires 4 of thewoven disk 2. Thus, there is an integral molding between thewaist 1 and thedisk 2, an integral molding between thedisk 2 and thebarb 3, a tubular mesh for thewaist 1, and a disk mesh for thedisk 2. Preferably, theelastic metal wire 4 is a nickel-titanium alloy metal wire, so that the single-disc ventricular septal defect occluder has strong self-expansibility and is not deformed under pressure.

Furthermore, thebarb 3 is formed by locally flattening theelastic metal wire 4 and then performing laser engraving, so that thebarb 3 is not easy to fall off, and the single disc type ventricular septal defect occluder can be firmly and reliably attached to the residual ventricular septal surface. Specifically, as shown in fig. 4, theelastic wire 4 has aflat portion 41 formed by partial forging, and thebarb 3 is formed by laser engraving of theflat portion 41; theflat part 41 is provided with a carvinggroove 42 after laser carving, the inner end of thebarb 3 is connected with the near end of the carvinggroove 42, the outer end of thebarb 3 faces the near end of the single-disc type ventricular septal defect occluder, thebarb 3 formed thereby is arc-shaped and similar to C-shaped, and the opening of thebarb 3 of the arc-shaped structure faces the near end of the single-disc type ventricular septal defect occluder. The conveying device for conveying the patent ductus arteriosus occluder generally comprises a sheath tube and a push rod, wherein the push rod is rotatably and movably arranged in the sheath tube in a penetrating way, and the push rod is detachably connected with the near end of the single-disc ventricular septal defect occluder. When an operator moves a push rod to the direction close to the operator, the push rod drives the single-disc ventricular septal defect occluder to move together to the direction close to the operator, the near end of thewaist part 1 is firstly pulled into the sheath tube, then thewaist part 1 deforms from the near end to the far end and is pulled into the sheath tube, then thedisc 2 deforms from the near end to the far end and is pulled into the sheath tube, and finally, the single-disc ventricular septal defect occluder is gradually stretched into a straight line and is completely retracted into the sheath tube in a straight line shape. In the process, thebarb 3 can be deformed into a straight line along the direction that the single-disc ventricular septal defect occluder is pulled into the sheath tube and is attached to the carvinggroove 42 of theflat part 41, so that the inner end of thebarb 3 connected with theflat part 41, namely the root part of thebarb 3 is deformed or bent to a very small degree, the single-disc ventricular septal defect occluder can be repeatedly pushed and pulled for many times, an improper positioning area does not need to be selected due to the limitation of instruments, the risk of an operation is reduced, and the injury to a patient is reduced.

Further, as shown in fig. 1 to fig. 3, the single-disc ventricular septal defect occluder further comprises aproximal aggregation point 5 and adistal aggregation point 6, wherein the ends of the plurality ofelastic metal wires 4 of the knittedwaist portion 1 are constrained and fixed by theproximal aggregation point 5, and the ends of the plurality ofelastic metal wires 4 of the knitteddisc 2 are constrained and fixed by thedistal aggregation point 6. Theproximal collection point 5 is also adapted to be detachably connected to a push rod in the delivery device.

In summary, the single-disc ventricular septal defect occluder according to the present application can occlude completely without displacement or falling off, and simultaneously, complications caused by the clamping and anchoring properties of the ventricular septal defect occluder of the prior art with the double-disc structure can be avoided more easily. Therefore, the utility model effectively overcomes various defects in the prior art and has high industrial utilization value.

The above embodiments are merely illustrative of the principles and effects of the present invention, and are not to be construed as limiting the invention. Modifications and variations can be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which may be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims (8)

1. A single-disc type ventricular septal defect occluder comprises a waist part (1) which is tubular and is used for being fixed at a ventricular septal defect position, and is characterized in that: waist (1) only is connected with at its distal end that is located the left ventricle side and is discoid disc (2), the inside of waist (1) and the inside of disc (2) all are fixed with the blood flow barrier membrane, disc (2) have barb (3) to set firmly on the side towards waist (1).

2. The single-disk ventricular septal defect occluder of claim 1, wherein: be integrated into one piece spare between waist (1) and disc (2), be integrated into one piece spare between disc (2) and barb (3).

3. The single-disk ventricular septal defect occluder of claim 1 or 2, wherein: the waist (1) and the disc (2) each comprise a plurality of elastic metal wires (4) woven together.

4. The single-disk ventricular septal defect occluder of claim 3, wherein: the elastic metal wire (4) is provided with a flat part (41) which is locally flattened, and the barb (3) is formed by laser engraving of the flat part (41).

5. The single-disk ventricular septal defect occluder of claim 4, wherein: be formed with carving groove (42) on flat portion (41) after laser sculpture, the inner of barb (3) links to each other with the near-end of carving groove (42), the outer end of barb (3) is towards the near-end of single disc ventricular septal defect occluder.

6. The single-disk ventricular septal defect occluder of claim 3, wherein: the elastic metal wire (4) is a nickel-titanium alloy metal wire.

7. The single-disk ventricular septal defect occluder of claim 3, wherein: the waist elastic metal wire fixing device is characterized by further comprising a near-end gathering point (5) and a far-end gathering point (6), the end portions of the elastic metal wires (4) of the waist portion (1) are restrained and fixed by the near-end gathering point (5), and the end portions of the elastic metal wires (4) of the disc (2) are restrained and fixed by the far-end gathering point (6).

8. The single-disk ventricular septal defect occluder of claim 1 or 2, wherein: the barb (3) is arc-shaped, and the opening of the barb (3) faces to the near end of the single-disc ventricular septal defect occluder.

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