CN106510777A - Atrial shunt - Google Patents

Abstract

The invention discloses an atrium shunt, which is characterized in that it comprises a right disk surface and a left disk surface, the right disk surface and the left disk surface are connected through a waist, and the right disk surface and the left disk surface are respectively provided with a net port on the right disk surface and a network port on the left disk surface. The network port, the network port on the right disk and the network port on the left disk are connected to each other, the right disk is provided with a wire steel sleeve, and the left disk is provided with a threaded steel sleeve. The invention has strong compliance, can maintain the size of the stoma, maintain the passage of blood flow, and maintain long-term non-union; the disc face of the atrial shunt has a certain clamping force on the atrial septum, and can be stably fixed on the atrial septum location, not easy to fall off and shake; the surface of the atrial shunt of the present invention in contact with the atrial septal muscle can be quickly endothelialized, but does not affect the fluidity of the left and right atrium holes; the shunt does not occupy the volume of the atrium, and is not easy to cause coagulation and Thrombus: using the atrial shunt of the present invention, the operation is convenient, and conventional interventional operations can be completed.

Description

Atrial shunt

technical field

The invention relates to an atrium shunt, which belongs to the technical field of medical instruments.

Background technique

In some heart diseases, there will be a significant difference in the pressure of the left and right atrium. For example, in patients with pulmonary hypertension, there is persistent right atrial hypertension, and the right atrial pressure needs to be reduced, otherwise it will lead to right heart enlargement and right heart failure. At this time, a defect can be created through room puncture, so that blood from the right atrium can flow to the left atrium, which can reduce the pressure of the right atrium and relieve the heart load. Another example is that patients with diastolic heart failure have left atrial hypertension, left heart enlargement, and left heart failure. At this time, a septostomy can also be made in the atrial septum so that blood from the left atrium can flow to the right atrium.

Atrial septostomy is a palliative method for the treatment of complex heart diseases. It is to establish communication between the left and right atria of the patient through interventional methods, so that the blood from the left and right atria can mix, so that the hemodynamics can be adjusted to a relatively stable state, and the left and right atria can be transmitted. The pressure between the atrium relieves the load on the heart and prevents patients from heart insufficiency.

The commonly used clinical ostomy generally uses a puncture sheath to puncture the atrial septum, make a hole, and use balloon dilation to expand the defect. However, this type of ostomy usually cannot accurately control the size of the stoma, and the postoperative defect is naturally closed, and there is a phenomenon of postoperative retraction of the stoma, which causes the stoma to be quickly closed due to endothelialization and loses the shunt function.

In order to solve the above problems, the foreign V-Wave company specially developed the atrial septal ostomy support (V-Wave, a single shunt device) to support the ostomy formed by the interventional method and avoid postoperative retraction of the ostomy. However, the delivery method of the device is complicated, the stent goes deep into the atrium, occupies the volume of the atrium, is not easy to be endothelialized, and will affect the hemodynamics in the atrium. In addition, the stent has no clamping force against the atrial septum, and it is easy to shake under the washing of the blood flow.

Another example is the ISAD II atrial shunt device produced by Corvia Medical, which is cut by laser and divided into two single-layer disks on the left and right. The right disk is straight, and the left disk is curved to the right. The two disks cooperate with each other to form Strong grip on the interatrial septum.

However, the compliance of the metal cutting stent is poor, it cannot be closely attached to the atrial septal muscle, and the endothelialization is slow.

Therefore, it is currently in demand in the market to design an atrial septal shunt that is firmly clamped, not easy to fall off, strong in compliance, and capable of rapid endothelialization.

In addition, for patients with long-term atrial septal defect, the heart has adjusted the left and right atrial pressures due to compensatory effects. The rapid increase in pressure can cause heart failure or arrhythmia, which is life-threatening. The palliative treatment is to implant a perforated atrial septal shunt to seal off the original larger defect, leaving a small defect to allow blood flow to maintain pressure balance between the left and right atrium. After the heart adapts in the later stage, the reserved defect will be blocked.

Contents of the invention

The technical problem to be solved by the present invention is to provide an atrial septal shunt, which solves how to design an atrial septal shunt that is firmly clamped, not easy to fall off, strong in compliance, and capable of rapid endothelialization.

In order to solve the above technical problems, the technical solution of the present invention is to provide an atrial shunt, which is characterized in that it includes a right disc surface and a left disc surface, the right disc surface and the left disc surface are connected by a waist, and the right disc surface and the left disc surface are respectively provided with There are network ports on the right disk surface and network ports on the left disk surface, and the network ports on the right disk surface and the network ports on the left disk surface are connected to each other. The right disk surface is equipped with a wire steel sleeve, and the left disk surface is provided with a threaded steel sleeve.

Preferably, the network port on the right disk surface and the network port on the left disk surface are respectively set at the middle positions of the right disk surface and the left disk surface.

Preferably, the diameter of the waist portion is greater than the diameter of the mesh port on the right disk surface and the diameter of the mesh port on the left disk surface.

Preferably, a self-expandable vascular stent is sutured inside the waist.

Preferably, the wire-filled steel sleeve and the threaded steel sleeve are not coaxial, and are respectively arranged at both ends of the diagonal lines of the right disk surface and the left disk surface.

Preferably, the surfaces of the right and left discs are coated with a drug that inhibits endothelialization.

Preferably, the right disk surface and the left disk surface may be parallel to each other, or one of the disk surfaces is inclined inward to form an included angle, or both disk surfaces are inclined inward to form an included angle.

Preferably, the right disc surface, the left disc surface and the waist are all woven with NiTi mesh in the form of one wire pressed against one wire.

The present invention has strong compliance. After atrial septostomy, implanting the atrial shunt of the present invention can maintain the size of the stoma, keep the passage of blood flow, and maintain long-term non-union; the disc surface of the atrial shunt It has a certain clamping force on the atrial septum, and can be stably fixed at the position of the atrial septum, and is not easy to fall off or shake; the surface of the atrial shunt and the atrial septal muscle in contact with each other can be quickly endothelialized, but it does not affect the left and right heart The flowability of the room hole; the shunt does not occupy the volume of the atrium, and it is not easy to cause coagulation and thrombus; the use of the atrial shunt of the present invention is convenient for operation, and conventional interventional operations can be completed.

Description of drawings

Fig. 1 is the front view of the right disk surface of a kind of atrial shunt;

Fig. 2 is a side view (1) of an atrial shunt;

Fig. 3 is a side view (two) of an atrial shunt;

Fig. 4 is a side view (3) of an atrial shunt;

Fig. 5 is a rendering of an atrial shunt implanted into the atrium;

Fig. 6 is a side view (four) of an atrial shunt;

Fig. 7 is a side view (5) of an atrial shunt.

detailed description

In order to make the present invention more comprehensible, preferred embodiments are described in detail below with accompanying drawings.

Example 1

An atrial shunt of the present invention, the entire shunt is woven into a net with memory function and superelastic NiTi wire, and its two ends are ligated by steel sleeves and then heat-shaped. The shunt has good flexibility and can pass through the sheath delivery. As shown in Fig. 1 and Fig. 2, the diverter includes a right disk 1, a left disk 2 and a short waist 3, and the right disk 1 and the left disk 2 are parallel to each other. In the center of the two disks, there is a circular middle through hole c that runs through the left and right disks (that is, the right disk 1 and the left disk 2) and the waist 3 (the two ends of the middle through hole c are the network ports 11 of the right disk and the ports of the left disk). Network port 21), the diameter of the waist 3 of the present invention is greater than the diameter of the middle through hole c on the right disk surface 1 and the left disk surface 2. The waist 3 has a strong supporting force, and can support the small artificial atrial septal incision to a diameter of more than 8mm.

As shown in Fig. 2, the present invention is different from the common occluder in that the ligature steel sleeves at both ends of the shunt are not coaxial, but are located at the two diagonal ends of the left and right disc surfaces respectively.

The two disks of the shunt are respectively exposed to the left atrium and the right atrium, and the middle waist 3 connects the two disks and passes through the defect of the atrial septum, similar to a common umbrella-type atrial septal defect occluder. The entire shunt is fixed on the interatrial septum by the clamping force of the two disks.

The middle through hole c in the middle of the left and right disks is always kept unobstructed (that is, the network port 11 on the right disk and the network port 21 on the left disk are connected to each other), allowing blood to circulate in the left and right atriums.

The right panel 1, the left panel 2, and the waist 3 are all woven with NiTi netting in which one wire presses one wire to increase the support effect of the shunt.

After the shunt is implanted in the interatrial septum, as time goes by, the middle through hole c of the shunt may no longer be unobstructed due to endothelialization of cells, or even completely closed, losing the function of balancing the left and right atrial pressure. Therefore, a layer of drugs that inhibit endothelialization, such as rapamycin, paclitaxel, etc., can be coated on the surface of the stent.

After using the shunt of the present invention, the pressure between the left and right atrium can be balanced, and the blood flow can be directed to the atrium with lower pressure, as shown in FIG. 5 .

Example 2

In this embodiment, as shown in FIG. 3 , one of the right disk surface 1 and the left disk surface 2 is inclined inwardly to form an included angle, which increases the firmness of the shunt fixed on the interatrial septum.

Others are the same as in Example 1.

Example 3

In this embodiment, as shown in FIG. 4 , both the right disk surface 1 and the left disk surface 2 are inclined inward to form an included angle, and are clamped to each other to increase the firmness of the shunt fixed on the interatrial septum.

Others are the same as in Example 1.

Example 4

In this embodiment, as shown in Figure 7, the right disk surface 1 and the left disk surface 2 can be different axes. In the direction of the same axis, the two disk surfaces are staggered by a certain distance, and deviate from each other by 2 to 5 mm in the vertical direction, forming an eccentric effect and similar in appearance. Eccentric ventricular defect. Without increasing the difficulty of passing the sheath of the shunt, the diameter of the waist 3 of the shunt can be appropriately increased to make the supporting effect more obvious.

Others are the same as in Example 1.

Example 5

In this embodiment, as shown in FIG. 6 , a short self-expandable vascular stent is sutured in the waist 3 to further enhance the supporting force of the waist of the shunt.

Others are the same as in Example 1.

Claims (8)

1. a kind of atrium diverter, it is characterised in that including right card (1) and left card (2), right card (1) and left card (2) Between by waist (3) connect, network interface (11), the net of left card of right card are respectively equipped with right card (1) and left card (2) Mouth (21), mutually connects between the network interface (21) of the network interface (11) and left card of right card, and right card (1) is provided with wired steel bushing B (), left card (2) are provided with steel screw bushing (a).

2. a kind of atrium diverter as claimed in claim 1, it is characterised in that the network interface (11) of described right card, left disk The network interface (21) in face is respectively arranged on the centre position in right card (1) and left card (2).

3. a kind of atrium diverter as claimed in claim 1, it is characterised in that described waist (3) with diameter greater than right disk The diameter of the network interface (21) of the diameter and left card of the network interface (11) in face.

4. a kind of atrium diverter as described in claim 1 or 3, it is characterised in that is sewed with described waist (3) From swollen intravascular stent.

5. a kind of atrium diverter as claimed in claim 1, it is characterised in that described wired steel bushing (b) and steel screw bushing A () be not coaxial, be respectively arranged on the diagonal two ends of right card (1) and left card (2).

6. a kind of atrium diverter as claimed in claim 1, it is characterised in that described right card (1) and left card (2) The medicine of one layer of suppression endothelialization of surface-coated.

7. a kind of atrium diverter as claimed in claim 1, it is characterised in that described right card (1) and left card (2) can It is parallel to each other, or one of card slopes inwardly to form angle, or two cards slopes inwardly to form angle.

8. a kind of atrium diverter as claimed in claim 1, it is characterised in that described right card (1), left card (2), waist The NiTi net braidings of the netting mode of 1 silk are pressed to form using 1 silk in portion (3).