Valve blood flow regulation device

Abstract

The application relates to a valve blood flow regulating device and belongs to the technical field of medical instruments. The device comprises a hollow net-shaped blood flow regulating component arranged in a valve closing area, a fixing component arranged in an in-out heart blood vessel and used for limiting the position of the blood flow regulating component, and a connecting piece; the two ends of the blood flow regulating component are connected with the fixing component through the connecting piece. The device has the advantages of simple structure design, easy-to-obtain manufacturing material, general processing difficulty, controllable cost, simple and convenient operation, rapid effect, and complete recovery after implantation. After artificial tricuspid valve replacement, the device can help patients to smoothly pass through the transition period after the tricuspid valve replacement by retaining a certain amount of regurgitation.

Description

Technical Field

[0001] This invention relates to a valve blood flow regulation device, belonging to the field of medical device technology. Background Technology

[0002] Isolated tricuspid regurgitation refers to tricuspid regurgitation occurring alone without associated left ventricular valvular disease or pulmonary hypertension. With the increasing aging population and the rise in age-related diseases such as atrial fibrillation, the prevalence of isolated tricuspid regurgitation is increasing year by year, becoming a common valvular disease in clinical practice, including severe cases. Due to the risks of surgery, surgical repair of tricuspid regurgitation is only recommended concurrently with left ventricular valvular surgery, and is not recommended for patients with isolated tricuspid regurgitation. Therefore, minimally invasive interventional treatment of tricuspid regurgitation has become a promising treatment option for isolated tricuspid regurgitation. Currently, clinical studies have found that in patients with severe tricuspid regurgitation, symptoms almost completely disappear after transcatheter tricuspid valve replacement (TCVPR). However, the massive preoperative tricuspid regurgitation blood flow immediately after surgery flows into the pulmonary vessels and left ventricular system, easily leading to a sudden and significant increase in pulmonary blood flow and a sudden and significant increase in left ventricular preload. This can result in pulmonary edema and left ventricular failure symptoms that are difficult to self-regulate, causing a sudden deterioration in postoperative cardiac function. Therefore, there is an urgent need in this technical field for a valve flow regulating device to regulate blood flow through the heart valve in the short or long term. Firstly, it can be used to retain a certain amount of regurgitation after tricuspid valve replacement, preventing the massive preoperative tricuspid regurgitation blood flow from immediately flowing into the pulmonary vessels and left ventricular system, thus avoiding a sudden deterioration in postoperative cardiac function. Secondly, after artificial tricuspid valve placement, implanting this valve flow regulating device can retain a certain amount of regurgitation to help patients smoothly transition through the postoperative period after tricuspid valve replacement. Secondly, when this valve blood flow regulating device covers the choke membrane, this device can also be used alone, placed in the central area of ​​tricuspid regurgitation to block tricuspid regurgitation, thereby reducing tricuspid regurgitation and playing a direct therapeutic role in tricuspid regurgitation. Summary of the Invention

[0003] The purpose of this invention is to solve the technical problem of how to help patients smoothly navigate the transition period after tricuspid valve replacement surgery.

[0004] To address the aforementioned problems, the present invention provides a valve blood flow regulating device, comprising a hollow mesh blood flow regulating component disposed in the valve closure region, a fixing component and a connector disposed in the blood vessels entering and exiting the heart to define the position of the blood flow regulating component; both ends of the blood flow regulating component are connected to the fixing component via the connector.

[0005] Preferably, the blood flow regulating component is disposed in the blood channel between the atrium and the ventricle, or in the blood channel between the ventricle and the pulmonary artery.

[0006] Preferably, the fixation assembly includes a first fixation assembly disposed in the superior vena cava and a second fixation assembly disposed in the pulmonary artery.

[0007] Preferably, the blood flow regulating component is elastic; the fixing component is elastic, and when the fixing component is unfolded, it is a hollow mesh structure that fits tightly against the blood vessel wall.

[0008] Preferably, the surfaces of the blood flow regulating component, the fixing component, and the connector are provided with a hydrophilic anticoagulant coating.

[0009] Preferably, the blood flow regulating component is made of shape memory metal or polymer material.

[0010] Preferably, the fixing component is made of shape memory metal.

[0011] Preferably, the outer surface of the blood flow regulating component is provided with a flow-blocking membrane.

[0012] Preferably, the fixing component is provided with a connector for device recovery.

[0013] Preferably, the connector is a protruding spherical or hook-shaped part.

[0014] Compared with the prior art, the present invention has the following beneficial effects:

[0015] The invention features a simple structural design, readily available materials, moderate processing difficulty, controllable cost, simple and convenient operation, and rapid onset of action. It can also be fully recycled and its size can be replaced according to the clinical situation of patients at different stages of treatment. Attached Figure Description

[0016] Figure 1 This is a schematic diagram showing blood flowing out of the right ventricle during tricuspid regurgitation.

[0017] Figure 2 This is a schematic diagram showing blood flowing out of the right ventricle after transcatheter tricuspid valve replacement.

[0018] Figure 3 A schematic diagram showing the measurement and installation position of the fixation component after transcatheter tricuspid valve replacement;

[0019] Figure 4 A schematic diagram showing the release of the fixing assembly via the delivery sheath;

[0020] Figure 5 A schematic diagram of the right ventricle after the device of the present invention has been installed;

[0021] Figure 6 This is a schematic diagram showing blood flowing out of the right ventricle after the present invention is installed;

[0022] Figure 7This is a schematic diagram showing blood flowing out of the right ventricle after the surface of the blood flow regulating component of the present invention is covered with a flow-blocking membrane;

[0023] Figure 8 This is a schematic diagram of a fixed component structure according to the present invention;

[0024] Figure 9 This is a schematic diagram of another fixing component structure according to the present invention;

[0025] Figure 10 This is a schematic diagram of a blood flow regulation component according to the present invention;

[0026] Figure 11 This is a schematic diagram of another blood flow regulation component structure according to the present invention;

[0027] Reference numerals: 1. Blood flow regulating component; 2. Fixation component; 3. Connector; 4. Superior vena cava; 5. Pulmonary artery; 6. Valve; 7. Connector head. Detailed Implementation

[0028] To make the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings:

[0029] like Figure 1-11 As shown, this invention provides a valve blood flow regulation device, comprising a hollow mesh-like blood flow regulation component 1 disposed in the closed region of a valve 6, a fixing component 2 disposed in the blood vessels entering and exiting the heart to define the position of the blood flow regulation component 1, and a connector 3; both ends of the blood flow regulation component 1 are connected to the fixing component 2 via the connector 3; the blood flow regulation component 1 is disposed in the blood channel between the atrium and the ventricle, or in the blood channel between the ventricle and the pulmonary artery 5. The fixing component 2 includes a fixing component one disposed in the superior vena cava 4 and a fixing component two disposed in the pulmonary artery 5. The blood flow regulation component 1 is elastic; the fixing component 2 is elastic; when the fixing component 2 is unfolded, it is a hollow mesh structure tightly attached to the blood vessel wall. The surfaces of the blood flow regulation component 1, the fixing component 2, and the connector 3 are coated with a hydrophilic anticoagulant coating. The blood flow regulation component 1 is made of shape memory metal or a polymer material. The fixing component 2 is made of shape memory metal. A flow-blocking membrane is disposed on the outer surface of the blood flow regulation component 1. The fixing component 2 is provided with a connector 7 for device recycling. The connector 7 is a protruding spherical or hook-shaped part.

[0030] Example

[0031] This invention provides a valve blood flow regulating device, which can be implanted in the human body for short or long term. The structure includes a fixation component 2 and a blood flow regulating component 1. The main body of both components is woven from nickel-titanium alloy wire, or it can be made of nickel-titanium alloy by laser cutting. It has an unfolded state and a contracted state. The surfaces of the fixation component 2 and the blood flow regulating component 1 are coated or covered with a functional hydrophilic anticoagulant coating, which can prevent the formation of thrombi on the device surface, prevent endothelialization of the device surface, and facilitate the complete removal of the device.

[0032] The fixation component 2 and the blood flow regulation component 1 rely on the metal memory property of nickel-titanium alloy, which allows the fixation component 2 and the blood flow regulation component 1 to retract into the delivery sheath for transport and to return to their original shape after being released.

[0033] Fixation component 2 deforms after being released from the delivery sheath due to its metallic memory properties, allowing it to adhere tightly to the blood vessel wall for fixation. Flow regulation component 1, through its nickel-titanium alloy metallic memory deformation, forms a hollow frame structure (which can be covered with a flow-blocking membrane or remain a metal frame structure depending on requirements). Fixation component 2 and flow regulation component 1 are connected by connector 3. (Note: This connection can be a single piece manufactured during the entire process, including different lengths and sizes; alternatively, they can be initially packaged separately, and after measurement during surgery, the accompanying engineer or surgeon selects the appropriate length of connector 3 to connect and lock to fixation component 2 and flow regulation component 1 respectively during the operation, achieving personalized customization for each patient on-site.)

[0034] The appropriate dimensions of connector 3 are as follows: the blood flow regulating component 1 is located in the central region of the heart valve 6; when the surface of the blood flow regulating component 1 is covered with a choke membrane, the blood flow regulating component 1 can be used to block valvular regurgitation, thus directly treating valvular regurgitation; when the surface of the blood flow regulating component 1 is not covered with a choke membrane, i.e., it is only a hollow frame structure woven from nickel-titanium alloy wire, the blood flow regulating component 1 can prevent the tricuspid valve from completely closing, thus preserving a certain amount of blood flow regurgitation, in order to avoid a sudden increase in pulmonary blood flow exceeding the tolerable maximum value, and also to avoid a sudden increase in left ventricular preload, thus preventing left heart failure.

[0035] The device of this invention can be completely recovered after release, and the valve can be restored to its original hemodynamic state after recovery.

[0036] The accessories of the device of the present invention also include: a delivery sheath, a delivery cable, and a snare;

[0037] Among them: the distal end of the sheath body of the delivery sheath has a curved arc, and the sheath body has scale marks that can be visualized under X-ray, so as to measure the length and select the appropriate size of the device for implantation.

[0038] like Figure 1-7 The diagram illustrates the usage process of this invention.

[0039] like Figure 1 The diagram shown illustrates the flow of blood out of the right ventricle during tricuspid regurgitation. Figure 1 The image shows a massive amount of tricuspid regurgitation before the operation, flowing from the right ventricle to the right atrium, with only a small amount of blood flowing to the pulmonary artery.

[0040] like Figure 2 The diagram shown illustrates the outflow of blood from the right ventricle after a transcatheter tricuspid valve replacement procedure. Figure 2 The image shows that after transcatheter tricuspid valve replacement, the artificial tricuspid valve blocks blood backflow, and all blood goes to the pulmonary artery and left ventricular system.

[0041] like Figure 3 The diagram shown is a schematic of measuring the position of the fixation component 2 after transcatheter tricuspid valve replacement surgery. Figure 3 The diagram shows how, after transcatheter tricuspid valve replacement, measurements are taken using a catheter with radiopaque graduations or a delivery sheath to calculate the distance between the fixation component 2 and the blood flow regulating component 1, and then a connector 3 of appropriate length is selected.

[0042] like Figure 4 The diagram shows the release of fixation component 2 via a delivery sheath. The fixation cable is retracted from the delivery sheath, and fixation component 2 is released into the pulmonary artery 5. Fixation component 2 unfolds and closely adheres to the vessel wall of the pulmonary artery 5 by means of metal memory, thus playing a fixation role. Fixation component 2 has a hollow frame structure and does not affect blood flow. The same operation is performed to release another fixation component 2 into the superior vena cava 4.

[0043] like Figure 5 The diagram shown is a schematic of the right ventricle after the device of the present invention has been installed.

[0044] like Figure 6 The diagram shown illustrates blood flowing out of the right ventricle after the present invention is installed.

[0045] Figure 5 , Figure 6 As shown, after the device of the present invention is released, a certain amount of blood flow can be retained and returned to the right atrium through the blood flow regulating component 1. Figure 6 By selecting blood flow regulating components 1 of different sizes, the blood flow to the pulmonary artery and left heart system can be reduced accordingly, thus avoiding pulmonary edema and left heart failure caused by a sudden increase in blood flow to the pulmonary artery and left heart system that exceeds the self-regulation range.

[0046] The fixation component 2 inside the superior vena cava 4 has a protruding connector 7 with a spherical or hook-shaped shape, which is used for the retrieval of the device of the present invention. During retrieval, the entire device can be completely retrieved by using a conventional snare to snare the connector 7. The retrieval process is the reverse of the release process. First, the fixation component 1 of the superior vena cava is retrieved, then the blood flow regulating component 1 is retrieved, and finally the fixation component 2 of the pulmonary artery 5 is retrieved.

[0047] Figure 7 This is a schematic diagram showing blood flowing out of the right ventricle after the surface of the blood flow regulating component of the present invention is covered with a flow-blocking membrane;

[0048] Clinical studies have shown that in patients with severe tricuspid regurgitation, tricuspid regurgitation almost completely disappears after transcatheter tricuspid valve replacement. However, the massive amount of tricuspid regurgitant blood flow preoperatively immediately after surgery flows into the pulmonary vessels and left ventricular system, leading to a sudden and significant increase in pulmonary blood flow and a sudden and significant increase in left ventricular preload. This results in poorly self-regulating pulmonary edema and symptoms of left ventricular failure, causing a sudden deterioration in postoperative cardiac function. Based on the above background and reasons, this invention provides a cardiac valve blood flow regulation device.

[0049] Firstly, this invention is used for simultaneous implantation of the device after transcatheter tricuspid valve replacement. The head and tail fixation components 2 are placed in the superior vena cava 4 and pulmonary artery 5, respectively, so that the middle blood flow regulating component 1 is positioned in the center of the tricuspid valve leaflets. This achieves the effect of preserving a certain amount of regurgitation, reducing the flow to the pulmonary vessels, and lowering the left ventricular preload, thus helping the patient smoothly transition through the postoperative period after tricuspid valve replacement. After the patient adapts, the device is removed via a minimally invasive procedure. (e.g.) Figure 3-6 )

[0050] Secondly, when the blood flow regulating component 1 of the device of the present invention is covered with a choking membrane, the device can also be used alone. Through the implantation of the fixing component 2, the blood flow regulating component 1 is placed in the central region of tricuspid regurgitation. The choking membrane covering the surface of the blood flow regulating component 1 blocks the blood flow of tricuspid regurgitation, thereby reducing tricuspid regurgitation and directly treating it. (e.g.) Figure 7 )

[0051] Thirdly, the device of the present invention can also be used in pulmonary valve scenarios, and to help patients with short-term transition after transcatheter pulmonary valve replacement.

[0052] Figure 8 This is a schematic diagram of the structure of a fixing component 2 according to the present invention; wherein, the left figure is a front view and the right figure is a top view;

[0053] Figure 9 This is a schematic diagram of another fixing component 2 structure according to the present invention; wherein, the left figure is a front view and the right figure is a top view;

[0054] Figure 10This is a schematic diagram of a blood flow regulation component 1 according to the present invention; wherein, the left figure is a front view and the right figure is a top view;

[0055] Figure 11 This is a schematic diagram of another blood flow regulation component 1 according to the present invention; wherein, the left figure is a front view and the right figure is a top view;

[0056] illustrate: Figure 8 , 9 10 and 11 can be either fixed components or structural diagrams of blood flow regulation components. Such fine-tuning of shape and different combinations should be considered as equivalent embodiments of the present invention.

[0057] The design of the fixing component 2 and the blood flow regulating component 1 of the device of the present invention can have various embodiments, including but not limited to the above-mentioned cases and some fine-tuning.

[0058] The device of this invention can also be used after transcatheter pulmonary valve replacement. The principle is the same as that after tricuspid valve replacement, only the placement is different, so it will not be described further.

[0059] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention. Any modifications, alterations, and equivalent changes made by those skilled in the art based on the above-disclosed technical content without departing from the spirit and scope of the present invention are equivalent embodiments of the present invention. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A valve blood flow regulating device, characterized in that, It includes a hollow mesh blood flow regulating component located in the valve closure area, a fixing component and a connector located in the blood vessels entering and exiting the heart to limit the position of the blood flow regulating component; the two ends of the blood flow regulating component are respectively connected to the fixing component through the connector; The fixation components include a first fixation component located in the superior vena cava and a second fixation component located in the pulmonary artery; The blood flow regulating component is elastic; the fixing component is elastic, and when the fixing component is unfolded, it is a hollow mesh structure that fits tightly against the blood vessel wall; The blood flow regulating component does not have a flow-blocking membrane.

2. The valve blood flow regulating device according to claim 1, characterized in that, The blood flow regulating component is located in the blood channel between the atrium and ventricle, or in the blood channel between the ventricle and pulmonary artery.

3. The valve blood flow regulating device according to claim 1, characterized in that, The surfaces of the blood flow regulating component, the fixing component, and the connector are provided with a hydrophilic anticoagulant coating.

4. The valve blood flow regulating device according to claim 1, characterized in that, The blood flow regulation component is made of shape memory metal or polymer material.

5. The valve blood flow regulating device according to claim 1, characterized in that, The fixing component is made of shape memory metal.

6. The valve blood flow regulating device according to claim 1, characterized in that, The fixing component is provided with a connector for device recovery.

7. A valve blood flow regulating device according to claim 6, characterized in that, The connector is a protruding spherical or hook-shaped part.

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