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CN113545813A - Self-expanding plugging device - Google Patents

Self-expanding plugging device
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Publication number
CN113545813A
CN113545813ACN202010324912.XACN202010324912ACN113545813ACN 113545813 ACN113545813 ACN 113545813ACN 202010324912 ACN202010324912 ACN 202010324912ACN 113545813 ACN113545813 ACN 113545813A
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port
self
blood
inner cavity
expanding
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CN202010324912.XA
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Chinese (zh)
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王宝
林林
徐军
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Shanghai Huihe Medical Instrument Co ltd
Shanghai Huihe Healthcare Technology Co Ltd
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Shanghai Huihe Medical Instrument Co ltd
Shanghai Huihe Healthcare Technology Co Ltd
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Abstract

Translated fromChinese

本申请提供一种自膨胀式封堵装置,其用于植入心脏瓣膜之间,该装置包括自膨胀体,其具有:弹性表面,其沿轴线A周向延伸,形成中空的内腔;第一端口,其设于该弹性表面的近端,且该第一端口周向环绕该轴线A;以及第二端口,其设于该弹性表面的远端,且第二端口周向环绕该轴线A;该第一端口、该内腔和该第二端口相互连通,该第二端口的尺寸大于该第一端口的尺寸,本申请的自膨胀式封堵装置巧妙将自膨胀式封堵装置的结构与心脏收缩舒张时血液的流动相结合。针对心脏瓣膜反流患者,在心脏收缩期自膨胀式封堵装置可以和原生瓣膜配合有效地解决血液反流问题,在心脏舒张期又可减少对血液流动通道的阻挡。

Figure 202010324912

The present application provides a self-expanding occlusion device for implantation between heart valves, the device comprising a self-expanding body having: an elastic surface extending circumferentially along the axis A to form a hollow lumen; A port provided at the proximal end of the resilient surface and the first port circumferentially surrounding the axis A; and a second port provided at the distal end of the resilient surface and the second port circumferentially surrounding the axis A The first port, the inner cavity and the second port are communicated with each other, the size of the second port is larger than the size of the first port, and the self-expanding plugging device of the present application skillfully combines the structure of the self-expanding plugging device Combined with the flow of blood during systole and diastole. For patients with valvular regurgitation, the self-expanding occlusion device can cooperate with the native valve to effectively solve the problem of blood regurgitation during systole, and can reduce the obstruction of blood flow channels during diastole.

Figure 202010324912

Description

Self-expanding plugging device
Technical Field
The embodiment of the application relates to the technical field of medical equipment, in particular to a self-expansion type plugging device.
Background
Mitral valve, tricuspid valve, aortic valve, pulmonary valve, etc. commonly occur as valvular insufficiency, and in the case of mitral valve, during systole, a portion of the blood in the left ventricle flows back through the orifice of the incompetent mitral valve to the left atrium. The left atrium receives blood from both left ventricular regurgitation and pulmonary venous inflow, and the volume of left atrial blood increases dramatically, raising pressure, and leading to hypertrophy of the left atrium.
In diastole, more blood flows from the left atrium to the left ventricle, so that the left ventricle is enlarged due to the enhanced contraction, after the compensation phase is progressed to the decompensation phase, both the left atrium and the left ventricle are subjected to heart failure, and further pulmonary congestion, pulmonary arterial hypertension, right ventricular enlargement, right atrial enlargement, right heart failure and body circulation congestion sequentially occur.
Traditional treatment means include active surgical approaches or palliative efforts to combat inevitable heart failure with drugs. Among the surgical methods are valve replacement and annuloplasty. In surgical procedures, typical open chest surgery is very invasive, requires the establishment of extracorporeal circulation, and has a high incidence of complications and risk of infection. Many patients do not tolerate the enormous surgical risk and can only remain indefinitely at risk for death.
At present, fewer products for treating mitral valve regurgitation and tricuspid valve regurgitation through minimally invasive catheters are approved in China, and the products need to change the structure of the heart in the healing process, thereby bringing great pressure and inadaptability to the heart after operation.
Thus, there is a need for a product that does not require changes to the heart structure while treating valve regurgitation through minimally invasive pathways.
Disclosure of Invention
In view of the above, the present application provides a self-expanding occlusion device to overcome or at least partially address the above-mentioned problems.
Embodiments of the present application provide a self-expanding occlusion device for implantation between heart valves, the device comprising a self-expanding body having:
an elastic surface extending circumferentially along axis a forming a hollow interior cavity;
a first port disposed at a proximal end of the resilient surface, the first port circumferentially surrounding the axis A; and
a second port disposed at a distal end of the resilient surface, the second port circumferentially surrounding the axis A;
the first port, the inner cavity and the second port are communicated with each other, the size of the second port is larger than that of the first port, so that when the ventricular blood is compressed to push the valve to be closed, the second port and the first port form a first pressure difference in the inner cavity, and therefore blood is promoted to flow into the inner cavity from the second port, and the self-expansion body is expanded; when the atrial blood is compressed to push the valve to open, a second pressure difference is formed between the second port and the first port in the inner cavity, the second pressure difference enables part of blood to flow out of the inner cavity from the second port, part of blood to flow into the inner cavity from the first port, and meanwhile part of blood flows to the second port from the first port outside the elastic surface, so that the blood in the inner cavity is enabled to flow out, and the self-expansion body is enabled to contract.
Another embodiment of the present application provides a self-expanding occlusion device for implantation between heart valves, the device comprising a self-expanding body having:
an elastic surface extending circumferentially along axis a forming a hollow interior cavity;
a first port disposed at a proximal end of the resilient surface, the first port circumferentially surrounding the axis A; and
a second port disposed at a distal end of the resilient surface, the second port circumferentially surrounding the axis A;
the first port, the inner cavity and the second port are communicated with each other, the size of the second port is larger than that of the first port, so that when aortic valve is closed by aortic blood backflow, a first pressure difference is formed between the second port and the first port in the inner cavity, and therefore blood is promoted to flow into the inner cavity from the second port, and the self-expansion body is expanded; when the aortic valve is pushed to open by the left ventricular blood pressure, a second pressure difference is formed between the second port and the first port in the inner cavity, the second pressure difference enables part of blood to flow out of the inner cavity from the second port, part of blood to flow into the inner cavity from the first port, and meanwhile part of blood flows to the second port from the first port outside the elastic surface, so that the blood in the inner cavity is enabled to flow out, and the self-expansion body is enabled to contract.
Another embodiment of the present application provides a self-expanding occlusion device for implantation between heart valves, the device comprising a self-expanding body having:
an elastic surface extending circumferentially along axis a forming a hollow interior cavity;
a first port disposed at a proximal end of the resilient surface, the first port circumferentially surrounding the axis A; and
a second port disposed at a distal end of the resilient surface, the second port circumferentially surrounding the axis A;
the first port, the inner cavity and the second port are communicated with each other, the size of the second port is larger than that of the first port, so that when pulmonary artery blood backflow pushes the pulmonary valve to close, the second port and the first port form a first pressure difference in the inner cavity, and therefore blood is promoted to flow into the inner cavity from the second port, and the self-expansion body is expanded; when the right ventricular blood pressure pushes the pulmonary valve to open, a second pressure difference is formed between the second port and the first port in the inner cavity, the second pressure difference enables part of blood to flow out of the inner cavity from the second port, part of blood flows into the inner cavity from the first port, and meanwhile part of blood flows to the second port from the first port outside the elastic surface, so that the blood in the inner cavity is enabled to flow out, and the self-expansion body is enabled to contract.
Optionally, the ratio of the opening area of the second port to the opening area of the first port is 2: 1-10: 1.
Optionally, the first port is provided with a first retaining ring connected to the resilient surface for defining the shape of the first port; the second port is provided with a second retaining ring connected to the resilient surface for defining the shape of the second port.
Optionally, the self-expanding occlusion device further comprises an anchoring unit having:
a connector passing through the first port, the lumen, and the second port;
a first anchor connected to the proximal end of the connecting member for anchoring to the atrium; and
a second anchor coupled to the distal end of the connector for anchoring to the ventricle.
Optionally, the first port is provided with a first fixing member, which is connected with the connecting member; the second port is provided with a second fixing piece which is connected with the connecting piece.
Optionally, the anchoring unit further has a safety cap covering the second anchor to reduce blood wash through tissue adjacent the second anchor.
Optionally, the resilient surface forms a cylinder-like shape when inflated.
Optionally, the resilient surface is comprised of a soft material whose shape and size when expanded is automatically adjusted according to the gap when the valve is opened and closed.
It can be seen from above technical scheme that the self-expansion formula plugging device of this application embodiment's simple structure, easily manufacturing to ingenious combine together the structure of self-expansion formula plugging device and the flow of blood when the diastole of cardiac contraction, to heart valve regurgitation patient, self-expansion formula plugging device can solve the palirrhea problem of blood with native valve cooperation effectively in the systole phase, clearance when plugging valve closure effectively, reducible self-expansion formula plugging device blocks blood flow channel again in the diastole phase.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present application, and other drawings can be obtained by those skilled in the art according to the drawings.
FIG. 1 is a perspective view of one embodiment of a self-expanding occlusion device of the present application;
FIG. 2 is an exploded view of an embodiment of a self-expanding occlusion device of the present application;
FIG. 3 is a bottom view of the self-expanding occlusion device of FIG. 1 looking upward from the bottom;
FIG. 4 is a schematic view of an embodiment of a self-expanding occlusion device of the present application as it expands within the heart;
FIG. 5 is a schematic view of an embodiment of a self-expanding occlusion device of the present application as it contracts within the heart;
FIG. 6 is a perspective view of an embodiment of a self-expanding occlusion device of the present application as it expands within the heart;
FIG. 7 is a perspective view of an embodiment of a self-expanding occlusion device of the present application as it contracts within the heart;
FIG. 8 is a perspective view of another embodiment of a self-expanding occlusion device of the present application as it expands within the heart;
FIG. 9 is a perspective view of one embodiment of the manner in which the anchoring unit 106 of a self-expanding occlusion device of the present application is secured;
FIG. 10 is a perspective view of an embodiment of a self-expanding occlusion device of the present application expanded between aortic valves;
FIG. 11 is a perspective view of an embodiment of a self-expanding occlusion device of the present application retracted between the aortic valves.
Element number
10: a self-expanding occlusion device; 101: an elastic surface; a: an axis; 102: a first port; 103: a second port; 104: a first retaining ring; 105: a second retaining ring; 106: an anchoring unit; 107: a connecting member; 108: an inner cavity; 109: a first anchor; 110: a second anchor; 111: a first fixing member; 112: a second fixing member; 113: a safety helmet.
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, but not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application shall fall within the scope of the protection of the embodiments in the present application.
By "proximal" is meant the end of the self-expanding occlusion device that is implanted in or near the atrium when the device is placed in the heart. By "distal" is meant the end of the self-expanding occlusion device that is implanted in or near the heart chamber when the device is placed in the heart.
The following further describes specific implementations of embodiments of the present application with reference to the drawings of the embodiments of the present application.
Referring to fig. 1A-7, in one particular implementation of the present application, a self-expandingocclusion device 10 is provided for implantation between heart valves, including leaflets and valve annuli, including, but not limited to, mitral, tricuspid, aortic, and pulmonary valves. The ventricles include the left ventricle and the right ventricle, and the atria include the left atrium and the right atrium. In this embodiment, the heart valve is a mitral valve or a tricuspid valve.
In this embodiment, the self-expandingocclusion device 10 has: aresilient surface 101 extending circumferentially along axis a, forming ahollow interior 108; afirst port 102 disposed at a proximal end of theresilient surface 101, thefirst port 102 circumferentially surrounding the axis a; and asecond port 103 disposed at a distal end of theresilient surface 101, thesecond port 103 circumferentially surrounding the axis a. The axis a may be the axial center line of the self-expandingocclusion device 10, and the material of theelastic surface 101 may be an elastomeric material acceptable to the human body.
Thefirst port 102, theinner cavity 108 and thesecond port 103 are communicated with each other, and the opening area of thesecond port 103 is larger than that of thefirst port 102. The shape of thefirst port 102 and the shape of thesecond port 103 may be circular, oval, or other regular and irregular shapes, and the opening area is the area of the ports. When thefirst port 102 and thesecond port 103 are both circular, the ratio of the opening areas of thefirst port 102 and thesecond port 103 is the ratio of the diameters of thefirst port 102 and thesecond port 103.
Referring to fig. 4 and 5, for example, when the mitral valve is pressurized to push the anterior and posterior valves of the mitral valve to close (as shown in fig. 4), the left ventricle is folded back towards the left atrium by being blocked by the mitral valve, which causes the pressure at thesecond port 103 to be greater than the pressure at thefirst port 102, thereby creating a first pressure differential in thelumen 108, which causes blood to flow from thesecond port 103 into thelumen 108, meanwhile, since the opening area of thesecond port 103 is larger than that of thefirst port 102, the volume of the blood flowing into theinner cavity 108 from thesecond port 103 is much larger than the volume of the blood flowing out from thefirst port 102 in theinner cavity 108, i.e., thesecond port 103, is much larger than thefirst port 102, thereby causing the self-expanding body to expand more rapidly, and a small amount of blood flowing out of thefirst port 102 can reflux a small amount of blood, so that thrombus is not easily generated. The opening of thesecond port 103 and thefirst port 102 is designed to ensure that regurgitation does not cause adverse effects to the heart, such as left atrial hypertrophy, and to effectively reduce thrombus formation.
When the left atrial blood pressure pushes the valve leaf to open, the blood in the left atrium flows to the left ventricle, the pressure of thefirst port 102 is greater than the pressure of thesecond port 103, so that a second pressure difference is formed in theinner cavity 108, the second pressure difference causes part of the blood to flow out of theinner cavity 108 from thesecond port 103, part of the blood flows into theinner cavity 108 from thefirst port 102, and part of the blood flows from thefirst port 102 to thesecond port 103 outside theelastic surface 101, and theelastic surface 101 is pressed to cause the blood in theinner cavity 108 to rapidly flow out, so that the self-expanding body contracts. Since the opening area of thefirst port 102 is smaller than the opening area of thesecond port 103, this increases the flow speed of part of the blood flowing from thefirst port 102 to thesecond port 103 outside theelastic surface 101.
In one embodiment, the ratio of the opening area of thesecond port 103 to the opening area of thefirst port 102 is 2: 1 to 10: 1, and in another embodiment, the ratio of the opening area of thesecond port 103 to the opening area of thefirst port 102 is 2: 1 to 6: 1. The ratio of the opening area of thesecond port 103 to the opening area of thefirst port 102 is summarized by the inventors through a large number of experiments, and the ratio of the opening areas is too small and too large to promote the rapid expansion and rapid contraction of theelastic surface 101.
Referring to fig. 1 to 3, in an embodiment of the present application, thefirst port 102 is provided with afirst fixing ring 104 connected to theelastic surface 101 for defining the shape of thefirst port 102 to ensure a stable flow area at the proximal end of the self-expandable occlusion device 10; thesecond port 103 is provided with asecond fixing ring 105 connected with theelastic surface 101 for defining the shape of thesecond port 103 to ensure a stable flow area at the distal end of the self-expandable occlusion device 10, and by adjusting the relative distance between thefirst fixing ring 104 and thesecond fixing ring 105, the size of the expansion of theelastic surface 101 and the position of theelastic surface 101 in apposition with the valve can be adjusted, for example, by reducing the distance between thefirst fixing ring 104 and thesecond fixing ring 105 in the vertical direction, the size of the expansion of theelastic surface 101 can be increased; simultaneous upward or downward movement of thefirst retaining ring 104 and thesecond retaining ring 105 may change the position of theresilient surface 101 into apposition with the valve.
Referring to fig. 2 and 6, the self-expandingocclusion device 10 further comprises an anchoring unit 106 having: aconnector 107 passing through thefirst port 102, thelumen 108, and thesecond port 103; afirst anchor 109 connected to the proximal end of the connectingmember 107 for anchoring to the atrium; and asecond anchor 110 connected to the distal end of the connectingmember 107 for anchoring to the ventricle. Theconnector 107 may be a guidewire or other structure. As shown in fig. 3, thesecond anchor 110 may be a helical structure that can be threaded into the ventricular wall. As shown in fig. 9, thesecond anchor 110 may also be in the form of a rivet that is passed through the ventricular wall and secured to the inner and outer walls of the ventricle. Of course, thefirst anchor 109 and thesecond anchor 110 are not limited to the above-described forms, and may have any other suitable structures.
Referring to fig. 1 and 3, thefirst port 102 is provided with a first fixingmember 111 connected to theconnection member 107; thesecond port 103 is provided with asecond fixing member 112 connected to theconnection member 107, which is designed to effectively stabilize the shapes of thefirst port 102 and thesecond port 103 against deformation caused by the impact of blood.
Referring to fig. 2, the anchoring unit 106 also has asafety cap 113 that covers thesecond anchor 110 to reduce blood from washing thesecond anchor 110 and nearby tissue to prevent the tissue from being torn.
As shown in fig. 6, theresilient surface 101 may be a relatively hard material that forms a cylinder-like shape when inflated.
As shown in fig. 8, theelastic surface 101 may also be made of a soft material, whose shape and size when expanded are automatically adjusted according to the gap when the valve is opened and closed.
Referring to fig. 10 and 11, in this embodiment, a self-expandingocclusion device 10 is used for implantation between the aortic heart valves. Unlike the previous embodiment, the self-expandingocclusion device 10 is implanted in the aortic valve with the second port facing the aorta and the first port facing the left ventricle. During the diastole of the left ventricle, the aortic valve is pushed to close by aortic blood backflow, a first pressure difference is formed between the second port and the first port in the inner cavity, meanwhile, because the opening area of the second port 103 is larger than that of the first port 102, the volume of blood flowing into the inner cavity 108 from the second port 103 is far larger than that of blood flowing out of the inner cavity 108 from the first port 102, namely, the blood flow of the second port 103 is far larger than that of the first port 102, so that the self-expanding body is expanded more quickly; during left ventricular systole, left ventricular blood pressure pushes the aortic valve open, the pressure at the first port 102 is greater than the pressure at the second port 103, thereby creating a second pressure differential in the lumen 108, which causes part of the blood to flow out of the lumen 108 from the second port 103, and part of the blood to flow into the lumen 108 from the first port 102, while part of the blood flows from the first port 102 to the second port 103 outside the elastic surface 101, pressing against the elastic surface 101, causing the blood in the lumen 108 to flow out rapidly, causing the self-expanding body to contract. Since the opening area of thefirst port 102 is smaller than the opening area of thesecond port 103, this increases the flow speed of part of the blood flowing from thefirst port 102 to thesecond port 103 outside theelastic surface 101.
Implanting a self-expandable occlusion device between the pulmonary valves of the heart in a manner similar to the operation principle of implanting an aortic valve (not shown), i.e. during diastole of the right ventricle, when the pulmonary valve is pushed to close by pulmonary arterial blood backflow, the second port and the first port form a first pressure difference in the inner cavity, so as to promote blood to flow into the inner cavity from the second port, and thus the self-expandable body is expanded; in the contraction period of the right ventricle, the right ventricular blood is pressurized to push the pulmonary valve to open, a second pressure difference is formed between the second port and the first port in the inner cavity, the second pressure difference enables part of blood to flow out of the inner cavity from the second port, part of blood flows into the inner cavity from the first port, and meanwhile part of blood flows from the first port to the second port outside the elastic surface to enable the blood in the inner cavity to flow out, so that the self-expansion body contracts.
To sum up, the self-expansion formula plugging device's of this application simple structure, easily manufacturing to ingenious combine together the structure of self-expansion formula plugging device and the flow of blood when the systole diastole, to heart valve regurgitation patient, the self-expansion formula plugging device can solve the regurgitation problem of blood with native valve cooperation effectively in the systole phase, clearance when shutoff valve closes effectively, reducible blockking to blood flow channel again in the diastole phase. The channels comprise channels for blood flowing between the left atrium and the left ventricle, between the right atrium and the right ventricle, between the aortic valve and the left ventricle and between the pulmonary valve and the right ventricle.
Finally, it should be noted that: the above embodiments are only used for illustrating the technical solutions of the embodiments of the present application, and are not limited thereto; although the present application has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions in the embodiments of the present application.

Claims (10)

1. A self-expanding occlusion device for implantation between heart valves, the device comprising a self-expanding body having:
an elastic surface extending circumferentially along axis a forming a hollow interior cavity;
a first port disposed at a proximal end of the resilient surface, the first port circumferentially surrounding the axis A; and
a second port disposed at a distal end of the resilient surface, the second port circumferentially surrounding the axis A;
the first port, the inner cavity and the second port are communicated with each other, the size of the second port is larger than that of the first port, so that when the ventricular blood is compressed to push the valve to be closed, the second port and the first port form a first pressure difference in the inner cavity, and therefore blood is promoted to flow into the inner cavity from the second port, and the self-expansion body is expanded; when the atrial blood is compressed to push the valve to open, a second pressure difference is formed between the second port and the first port in the inner cavity, the second pressure difference enables part of blood to flow out of the inner cavity from the second port, part of blood to flow into the inner cavity from the first port, and meanwhile part of blood flows to the second port from the first port outside the elastic surface, so that the blood in the inner cavity is enabled to flow out, and the self-expansion body is enabled to contract.
2. A self-expanding occlusion device for implantation between aortic heart valves, the device comprising a self-expanding body having:
an elastic surface extending circumferentially along axis a forming a hollow interior cavity;
a first port disposed at a proximal end of the resilient surface, the first port circumferentially surrounding the axis A; and
a second port disposed at a distal end of the resilient surface, the second port circumferentially surrounding the axis A;
the first port, the inner cavity and the second port are communicated with each other, the size of the second port is larger than that of the first port, so that when aortic valve is closed by aortic blood backflow, a first pressure difference is formed between the second port and the first port in the inner cavity, and therefore blood is promoted to flow into the inner cavity from the second port, and the self-expansion body is expanded; when the aortic valve is pushed to open by the left ventricular blood pressure, a second pressure difference is formed between the second port and the first port in the inner cavity, the second pressure difference enables part of blood to flow out of the inner cavity from the second port, part of blood to flow into the inner cavity from the first port, and meanwhile part of blood flows to the second port from the first port outside the elastic surface, so that the blood in the inner cavity is enabled to flow out, and the self-expansion body is enabled to contract.
3. A self-expanding occlusion device for implantation between heart and pulmonary valves, the device comprising a self-expanding body having:
an elastic surface extending circumferentially along axis a forming a hollow interior cavity;
a first port disposed at a proximal end of the resilient surface, the first port circumferentially surrounding the axis A; and
a second port disposed at a distal end of the resilient surface, the second port circumferentially surrounding the axis A;
the first port, the inner cavity and the second port are communicated with each other, the size of the second port is larger than that of the first port, so that when pulmonary artery blood backflow pushes the pulmonary valve to close, the second port and the first port form a first pressure difference in the inner cavity, and therefore blood is promoted to flow into the inner cavity from the second port, and the self-expansion body is expanded; when the right ventricular blood pressure pushes the pulmonary valve to open, a second pressure difference is formed between the second port and the first port in the inner cavity, the second pressure difference enables part of blood to flow out of the inner cavity from the second port, part of blood flows into the inner cavity from the first port, and meanwhile part of blood flows to the second port from the first port outside the elastic surface, so that the blood in the inner cavity is enabled to flow out, and the self-expansion body is enabled to contract.
4. A self-expanding occlusion device according to any of claims 1 to 3, wherein the ratio of the open area of the second port to the open area of the first port is from 2: 1 to 10: 1.
5. Self-expanding occlusion device according to any of claims 1 to 3, wherein the first port is provided with a first fixation ring connected to the elastic surface for defining the shape of the first port; the second port is provided with a second retaining ring connected to the resilient surface for defining the shape of the second port.
6. Self-expanding occlusion device according to any of claims 1 to 3, characterized in that it further comprises an anchoring unit having:
a connector passing through the first port, the lumen, and the second port;
a first anchor connected to the proximal end of the connector; and
a second anchor connected to the distal end of the connector.
7. The self-expanding occlusion device of claim 6, wherein the first port is provided with a first fastener connected to the connector; the second port is provided with a second fixing piece which is connected with the connecting piece.
8. The self-expanding occlusion device of claim 6, wherein the anchor unit further comprises a safety cap covering the second anchor to reduce blood wash into tissue adjacent the second anchor.
9. Self-expanding occlusion device according to any of claims 1 to 3, characterised in that the elastic surface forms a cylinder-like shape when expanded.
10. Self-expanding occlusion device according to any of claims 1 to 3, characterised in that the elastic surface consists of a soft material, the shape and size of which when expanded is self-adjusting according to the gap when the valve is open and closed.
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