阅读说明：本技术 一种心房间隔缺损封堵器及封堵器安装套装 (Atrial septal defect occluder and occluder installation suit ) 是由 徐靖 潘湘斌 于 2019-10-22 设计创作，主要内容包括：本发明提供了一种心房间隔缺损封堵器,涉及心脏手术器械技术领域。该心房间隔缺损封堵器包括右伞盘、腰盘和左伞盘；右伞盘通过腰盘与左伞盘连接,右伞盘与左伞盘同轴设置,左伞盘沿径向的一侧边缘设置有第一缺口；腰盘用于设置于心房间隔缺损内,以使左伞盘的第一缺口对应内脏的二尖瓣瓣叶。本发明的心房间隔缺损封堵器,与传统封堵器相比,在左伞盘的径向边缘设置一个缺口,缺口尺寸可设置较大,并且一个缺口易于将缺口对准二尖瓣瓣叶,提高了手术效率和准确度,防止左伞盘安装后在细微的活动中对二尖瓣瓣叶形成夹持或者挤压。在此基础上,本发明还提供了一种封堵器安装套装。(The invention provides an atrial septal defect occluder, and relates to the technical field of cardiac surgery instruments. The atrial septal defect occluder comprises a right umbrella disc, a waist disc and a left umbrella disc; the right umbrella disk is connected with the left umbrella disk through the waist disk, the right umbrella disk and the left umbrella disk are coaxially arranged, and a first notch is formed in the edge of one radial side of the left umbrella disk; the lumbar disc is used for being arranged in the atrial septal defect, so that the first notch of the left umbrella disc corresponds to the mitral valve leaflet of the viscera. Compared with the traditional occluder, the atrial septal defect occluder has the advantages that the gap is arranged on the radial edge of the left umbrella disc, the gap can be larger in size, and the gap is easy to align to the mitral valve leaflets, so that the operation efficiency and accuracy are improved, and the left umbrella disc is prevented from clamping or extruding the mitral valve leaflets in fine movement after being installed. On the basis, the invention also provides an occluder mounting set.)

1. An atrial septal defect occluder is characterized by comprising a right umbrella disc, a waist disc and a left umbrella disc; the right umbrella disk is connected with the left umbrella disk through the waist disk, the right umbrella disk and the left umbrella disk are coaxially arranged, and a first notch is formed in the edge of one radial side of the left umbrella disk; the lumbar disc is arranged in the atrial septal defect, so that the first notch of the left umbrella disc corresponds to the mitral valve leaflets of the viscera.

2. The atrial septal defect occluder of claim 1, further comprising a second notch; the second notch is positioned on one side of the left umbrella disc relative to the first notch.

3. The atrial septal defect occluder of claim 2, wherein the edges of said first and second notches are rounded.

4. The atrial septal defect occluder of claim 1, wherein the right umbrella disk and the left umbrella disk are each woven from a shape memory alloy.

5. The atrial septal defect occluder of claim 4, wherein said shape memory alloy is made of a biodegradable polymer.

6. The atrial septal defect occluder of claim 1, wherein the side of the left umbrella disc remote from the lumbar disc is coated with a flow-blocking membrane; one side of the right umbrella disc, which is far away from the waist disc, is coated with a flow-blocking film.

7. The atrial septal defect occluder of claim 6, wherein said flow-blocking membrane is a hydrophobic flow-blocking membrane.

8. An occluder mounting kit comprising a delivery sheath, a delivery cable and an atrial septal defect occluder of any of claims 1 to 7; the conveying steel cable and the atrial septal defect occluder are arranged in the conveying sheath, and the tail end of the conveying steel cable is connected with the right umbrella disc.

9. The occluder mounting kit of claim 8, wherein the delivery sheath is a flexible tube.

10. The occluder mounting kit of claim 8, further comprising a steel sleeve through which the end of the delivery cable is connected to the right umbrella disk.

Technical Field

The invention relates to the technical field of cardiac surgical instruments, in particular to an atrial septal defect occluder and an occluder mounting kit.

Background

Atrial Septal Defects (ASD) are a common congenital heart disease, and include secondary and primary atrial septal defects, with many secondary holes. Patients with atrial septal defects may experience physical decline, concussion of the heart, post-activity asthma, and the like at a young age. The larger the atrial septal defect, the greater the effect on the growth and development of the child.

The means for treating atrial septal defect is atrial septal defect plugging operation generally, and the adopted surgical equipment is an atrial septal defect plugging device.

The common atrial septal defect occluder comprises a right umbrella disc, a waist disc and a left umbrella disc which are connected in sequence. However, in clinic, as the atrial septal defect of some patients is closer to the mitral valve, the left umbrella disc of the conventional occluder will press the mitral valve leaflets, resulting in failure of occlusion. If the plugging device with smaller specification is selected, the risk that the plugging device falls off is increased.

The inventor designs the right umbrella disk or the left umbrella disk into a petal shape, so that a gap is formed between two adjacent petals, and the gap is used for preventing the edge of the umbrella disk from abutting against the mitral valve leaflets to cause compression. However, the fine movement of the right umbrella disk or the left umbrella disk in the shape of petals after installation is easy to clamp or squeeze the mitral valve leaflets, which causes damage to human body.

Disclosure of Invention

The invention aims to provide an atrial septal defect occluder which can avoid clamping or squeezing mitral valve leaflets through the shape of a notch, and one notch is easy to align and install, so that the efficiency and the accuracy of the operation are improved.

Another object of the present invention is to provide an occluder mounting kit, which can uniformly arrange an occluder and a mounting tool in a complete structure, thereby improving the efficiency of production and use.

The embodiment of the invention is realized by the following steps:

an atrial septal defect occluder comprises a right umbrella disc, a waist disc and a left umbrella disc; the right umbrella disk is connected with the left umbrella disk through the waist disk, the right umbrella disk and the left umbrella disk are coaxially arranged, and a first notch is formed in the edge of one radial side of the left umbrella disk; the lumbar disc is arranged in the atrial septal defect, so that the first notch of the left umbrella disc corresponds to the mitral valve leaflets of the viscera.

After the atrial septal defect occluder is arranged at the position of a cardiac defect, the lumbar disc is arranged in the atrial septal defect, and the right umbrella disc and the left umbrella disc are respectively positioned in the right atrium and the left atrium. At this point, the first notch is facing the mitral valve leaflets. Because only one notch is arranged on one left umbrella disc, the size of the heart of a normal person is calculated, the size of the first notch can be designed to be large enough, the fixation of the whole occluder is not affected, the movement of the occluder is avoided by the movement of a human body, and the notch wide enough to be large enough can prevent the left umbrella disc from clamping or extruding the mitral valve leaflets during the movement. In addition, because there is only one notch, it is also faster and easier to align the notch with the mitral valve leaflets during installation.

In a preferred embodiment of the present invention, the device further comprises a second notch; the second notch is positioned on one side of the left umbrella disc relative to the first notch. The technical effects are as follows: the second breach sets up in one side relative with first breach, does not lead to the fact the interference influence to the size of first breach, and at this moment, rotate the plugging device 180 degrees, first breach and second breach homoenergetic are direct just to mitral valve leaflet.

In a preferred embodiment of the present invention, edges of the first notch and the second notch are smoothly arranged. The technical effects are as follows: the rounded notches prevent pinching or pinching of the mitral valve leaflets.

In a preferred embodiment of the invention, the structure of the right umbrella disk and the structure of the left umbrella disk are both woven by shape memory alloy. The technical effects are as follows: the right umbrella disk and the left umbrella disk made of shape memory alloy can be bent and arranged in the conveying sheath before being installed, and after the occluder is arranged at the atrial septal defect position, the occluder can change the shape to realize occlusion of the atrial septal defect under a specific deformation condition.

In a preferred embodiment of the invention, the shape memory alloy is made of a biodegradable polymer. The technical effects are as follows: the biodegradable polymer is capable of being hydrolyzed and degraded by in vivo tissue fluid, various biological enzymes, cells and the like under the action of certain biological or chemical rules after being implanted into an organism, and finally decomposed into small molecules harmless to the organism, and the small molecules are discharged by metabolism of the organism or absorbed by the organism to develop into self tissues. After the shape memory alloy is biodegraded, the plugging device has good biocompatibility, and can be harmlessly disappeared after the complete treatment mission in the pathological process of a human body, so that the human body is prevented from being influenced by foreign matters for a long time.

In a preferred embodiment of the invention, one side of the left umbrella disc, which is far away from the waist disc, is coated with a flow-resistant film; one side of the right umbrella disc, which is far away from the waist disc, is coated with a flow-blocking film. The technical effects are as follows: the flow-resistant membrane can seal the damage between the left atrium and the right atrium and prevent liquid from flowing between the two cavities.

In a preferred embodiment of the present invention, the flow-blocking film is a hydrophobic flow-blocking film. The technical effects are as follows: the flow resisting film is preferably a hydrophobic flow resisting film, has the rejection capability on water, namely most solutions, is insoluble in water, and can prolong the service life of the flow resisting film.

An occluder mounting kit, which comprises a conveying sheath, a conveying steel cable and the atrial septal defect occluder; the conveying steel cable and the atrial septal defect occluder are arranged in the conveying sheath, and the tail end of the conveying steel cable is connected with the right umbrella disc.

The conveying sheath is used for loading and conveying the atrial septal defect occluder to the atrial septal defect position, the conveying steel cable is used for adjusting the specific installation position of the atrial septal defect occluder and adjusting the installation state of the atrial septal defect occluder, and the left umbrella disc is provided with the first notch and the second notch, so that the atrial septal defect occluder is conveyed from the right atrium to the left atrium, and the tail end of the conveying steel cable is connected with the right umbrella disc.

In a preferred embodiment of the invention, the delivery sheath is a flexible tube. The technical effects are as follows: since the atrial septal defect occluder is delivered from the blood vessel to the site of atrial septal defect, the delivery sheath is necessarily a flexible tube suitable for the extended shape of the blood vessel.

In the preferred embodiment of the invention, the umbrella further comprises a steel sleeve, and the tail end of the conveying steel cable is connected with the right umbrella disc through the steel sleeve. The technical effects are as follows: the steel sleeve is used for temporarily fixing the right umbrella disc at the tail end of the conveying steel cable, and the connecting structure of the steel sleeve is started to release the atrial septal defect occluder during installation.

The embodiment of the invention has the beneficial effects that:

compared with the traditional occluder, the atrial septal defect occluder has the advantages that the gap is arranged on the radial edge of the left umbrella disc, the gap can be larger in size, and the gap is easy to align to the mitral valve leaflets, so that the operation efficiency and accuracy are improved, and the left umbrella disc is prevented from clamping or extruding the mitral valve leaflets in fine movement after being installed.

The installation kit of the stopper of the invention not only has the technical effects of the atrial septal defect stopper, but also uniformly arranges the atrial septal defect stopper and the installation tool in a complete structure, thereby improving the production and use efficiency of the complete set of equipment.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.

FIG. 1 is a schematic structural diagram of an atrial septal defect occluder in accordance with an embodiment of the present invention;

FIG. 2 is a schematic diagram of the left umbrella disc in the atrial septal defect occluder in accordance with one embodiment of the present invention;

FIG. 3 is a schematic structural diagram of the atrial septal defect occluder provided in the second embodiment of the present invention;

FIG. 4 is a schematic diagram of the left umbrella disc in the atrial septal defect occluder provided by the second embodiment of the present invention;

FIG. 5 is a schematic view of the installation of the atrial septal defect occluder provided by the second embodiment of the present invention in a human body;

figure 6 is an operational schematic diagram of an occluder mounting kit according to a fifth embodiment of the present invention.

In the figure: 1-right umbrella plate; 2-lumbar disc; 3-left umbrella disc; 4-a first notch; 5-mitral valve leaflets; 6-a second notch; 7-a delivery sheath; 8-conveying a steel cable; and 9-steel sleeve.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein can be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or the orientations or positional relationships that the products of the present invention are conventionally placed in use, and are only used for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

Furthermore, the terms "horizontal", "vertical", "overhang" and the like do not imply that the components are required to be absolutely horizontal or overhang, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.

In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.

The first embodiment:

FIG. 1 is a schematic structural diagram of an atrial septal defect occluder in accordance with an embodiment of the present invention; fig. 2 is a shape view of a left umbrella disc 3 in the atrial septal defect occluder provided by the embodiment of the invention. Referring to fig. 1 and 2, the present embodiment provides an atrial septal defect occluder, which includes a right umbrella tray 1, a lumbar tray 2, and a left umbrella tray 3; the right umbrella disk 1 is connected with the left umbrella disk 3 through the waist disk 2, the right umbrella disk 1 and the left umbrella disk 3 are coaxially arranged, and a first gap 4 is arranged at the edge of one radial side of the left umbrella disk 3; the lumbar disc 2 is used to be placed in the atrial septal defect such that the first notch 4 of the left umbrella disc 3 corresponds to the mitral valve leaflet 5 of the viscera, preventing the left umbrella disc 3 from abutting against the mitral valve leaflet 5.

Wherein, the right umbrella disk 1 and the left umbrella disk 3 are arranged into a disk structure which extends along a plane and has a smaller thickness dimension in a mode of being vertical to the plane, and the connection along the thickness direction is realized through the waist disk 2. The left umbrella disk 3 is mounted with its edge close to the mitral valve leaflets 5 in the heart, so the first notch 4 is provided at the outer edge of the left umbrella disk 3.

The installation state of the atrial septal defect occluder and the working principle thereof are as follows: after the atrial septal defect occluder is arranged at the position of a cardiac defect, the lumbar disc 2 is arranged in the atrial septal defect, and the right umbrella disc 1 and the left umbrella disc 3 are respectively positioned in the right atrium and the left atrium. At this time, the first notch 4 is facing the mitral valve leaflets 5, but does not grip or press the mitral valve leaflets 5. Because only one notch is arranged on the outer edge of one left umbrella disc 3, the size of the first notch 4 can be designed to be large enough without affecting the fixation of the whole occluder when the size is calculated according to the size of the heart of a normal person. Because the movement of the occluder is brought by the unavoidable movement of the human body, the gap which is wide enough can prevent the left umbrella disk 3 from clamping or extruding the mitral valve leaflets 5 when moving. In addition, because there is only one notch, the operation of aligning the notch with the mitral valve leaflet 5 during installation is also faster and easier.

Second embodiment:

FIG. 3 is a schematic structural diagram of the atrial septal defect occluder provided in the second embodiment of the present invention; FIG. 4 is a schematic external view of the left umbrella disc 3 in the atrial septal defect occluder provided by the second embodiment of the present invention; fig. 5 is a schematic view of the installation of the atrial septal defect occluder provided by the second embodiment of the present invention in a human body. Referring to fig. 3, 4 and 5, the present embodiment provides an atrial septal defect occluder, which is substantially the same as the atrial septal defect occluder of the first embodiment, but the difference between the atrial septal defect occluder and the first embodiment is that the atrial septal defect occluder of the present embodiment further comprises a second notch 6; the second notch 6 is positioned at one side of the left umbrella disc 3 opposite to the first notch 4.

Further, referring to fig. 4, the edges of the first notch 4 and the second notch 6 are smoothly disposed.

Wherein, for the center of gravity balance of the whole atrial septal defect occluder, the first gap 4 and the second gap 6 are respectively in an axisymmetric shape, and the first gap 4 and the second gap 6 are respectively symmetrical.

The first notch 4 and the second notch 6 may be arc-shaped, or triangular, trapezoidal, or rectangular.

The third embodiment:

this embodiment provides an atrial septal defect occluder which is substantially the same as the atrial septal defect occluders of the first and second embodiments, except that in the atrial septal defect occluder of this embodiment, the structure of the right umbrella disk 1 and the structure of the left umbrella disk 3 are both woven from a shape memory alloy.

Further, the shape memory alloy is made of a biodegradable polymer.

Wherein the biodegradable polymer is L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester, polyglycolic acid or polydioxanone. Or the degradable polymer is a copolymer formed by copolymerizing at least two of the monomers forming the levorotatory polylactic acid, the racemic polylactic acid, the polyglycolic acid, the polylactic acid-glycolic acid copolymer, the polyhydroxyalkanoate, the polydioxanone, the polycaprolactone, the polygluconic acid, the polyhydroxybutyric acid, the polyanhydride, the polyphosphoester, the polyglycolic acid and the polydioxanone.

The fourth embodiment:

the present embodiment provides an atrial septal defect occluder, which is substantially the same as the atrial septal defect occluders of the first, second and third embodiments, and the difference between them is that in the atrial septal defect occluder of the present embodiment, the side of the left umbrella disk 3 away from the lumbar disk 2 is coated with a flow-blocking membrane (not labeled); one side of the right umbrella disk 1, which is far away from the waist disk 2, is coated with a flow-resistant film.

Further, the flow-blocking film is a hydrophobic flow-blocking film.

Fifth embodiment:

figure 6 is an operational schematic diagram of an occluder mounting kit according to a fifth embodiment of the present invention. Referring to fig. 6, the embodiment provides an occluder mounting set, which comprises a delivery sheath 7, a delivery cable 8 and the atrial septal defect occluder; the conveying steel cable 8 and the atrial septal defect occluder are arranged in the conveying sheath tube 7, and the tail end of the conveying steel cable 8 is connected with the right umbrella disc 1.

Further, as shown in fig. 6, the delivery sheath 7 is a flexible tube.

Further, as shown in fig. 6, it also comprises a steel sleeve 9, and the end of the conveying steel cable 8 is connected with the right umbrella disk 1 through the steel sleeve 9.

The working process is as follows:

firstly establishing a track from a femoral vein to an interatrial septum, inserting a conveying sheath catheter 7 through the track, then pushing a stopper connected with a conveying steel cable 8 to a damaged position between a left atrium and a right atrium, opening a left umbrella disk 3 under the monitoring of special instruments and equipment, withdrawing the conveying sheath catheter 7 and the conveying steel cable 8 after aligning a first gap 4 or a second gap 6 to a position of a mitral valve leaflet 5, clamping a lumbar disk 2 at the damaged position, opening a right umbrella disk 1 to form a blocking state, separating a steel sleeve 9 from the right umbrella disk 1, and taking out the steel sleeve 9, the conveying sheath catheter 7 and the conveying steel cable 8.

The above is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes will occur to those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.