An adjustable diversion device

Abstract

This invention relates to an adjustable shunt device, belonging to the field of medical device technology. The adjustable shunt device includes clamping components and an adjusting component for adjusting the distance between the clamping components. The clamping components include at least three clamping members, each having a first clamping arm, a second clamping arm, and a connecting arm located between the first and second clamping arms. The adjusting component includes connecting components that connect adjacent connecting arms and an actuating component that allows the connecting components to move, thereby adjusting the distance between the clamping components. The adjustable shunt device of this invention, including the adjusting component, can adjust the distance between the clamping components, thereby adjusting the size of the interatrial septum opening, thus improving the adaptability of the adjustable shunt device.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to an adjustable shunt device. Background Technology

[0002] Heart failure (HF) is a syndrome caused by impaired systolic and / or diastolic function of the heart, resulting in insufficient venous return and venous congestion, inadequate arterial perfusion, and ultimately, cardiac circulatory disorders. HF is a serious disease with a high incidence and mortality rate; its 5-year survival rate is similar to that of malignant tumors. The more severe the HF, the higher the risk of death, seriously threatening people's health and quality of life. HF is caused by various factors leading to abnormal changes in the structure and function of the heart, impairing ventricular systolic ejection and / or diastolic filling functions, thus causing a complex clinical syndrome.

[0003] Heart failure can be classified according to its location as left ventricular failure, right ventricular failure, or biventricular failure. Based on clinical manifestations, it can also be divided into systolic heart failure and diastolic heart failure, with diastolic heart failure (DHF) accounting for approximately half of all heart failure cases. In China, there are over 12 million heart failure patients, representing an incidence rate of about 2-3%. Of these, approximately 6 million have diastolic heart failure. Diastolic heart failure is more prevalent among the elderly, accounting for 66.99% of all diastolic heart failure cases.

[0004] The main causes of heart failure include hypertension, coronary heart disease, myocardial infarction, valvular heart disease, atrial fibrillation, and cardiomyopathy. Cardiovascular diseases cause damage to the left ventricle, leading to pathological remodeling of the left ventricle and consequently, decreased cardiac function. This means that for every patient successfully treated for myocardial infarction, there is a potential patient with heart failure.

[0005] Existing treatments for heart failure all have limitations, as detailed below:

[0006] a. Optimized drug treatment cannot fundamentally eliminate the cause of the disease, and there is still a possibility of recurrence;

[0007] b. Cardiac resynchronization therapy (CRT) is ineffective in at least 20% of heart failure patients;

[0008] c. Left ventricular assist device (LVAD) surgery requires cardiopulmonary bypass, which is not only highly invasive with a high complication rate, but also expensive and difficult to obtain. In addition, the conditions for performing the surgery are not available in China.

[0009] d. Heart transplantation can fundamentally solve the problem, but the source of donors is very limited and the price is expensive.

[0010] One existing technological solution is to implant a shunt device in the atrial septum between the left and right atria, which has been proven effective in clinical trials. However, existing shunt devices still require further improvement in structure and performance. For example, Corvia Medical has designed an all-metal alloy stent for shunting from the left to the right atrium in diastolic heart failure. This alloy stent does not contain valves, and the internal blood flow channels are normally open. However, under non-ideal conditions, it can easily cause excess shunting, forming a shunt from the right to the left atrium, further impairing the left atrium's ability to fill with oxygenated blood, and posing a risk of paradoxical embolism.

[0011] Because a stoma must be created at the implantation site before the shunt device can be implanted, situations often arise where there is excessive or insufficient shunt flow. Currently, existing shunt devices can only assess and predict the required shunt size before implantation, i.e., the orifice size of the shunt device and its placement within the appropriate stoma. This method requires thorough pre-operative assessment, increasing the surgical complexity; furthermore, if the orifice size of the shunt device is incompatible post-operatively, under current conditions, the implanted device is usually retrieved and replaced with a suitable one, further prolonging the surgical time and increasing surgical risks.

[0012] Therefore, it is desirable to provide an adjustable shunt device including an adjustment component that can adjust the distance between clamping components, thereby adjusting the size of the interatrial septum opening, thus improving the adaptability of the adjustable shunt device. Summary of the Invention

[0013] To address the aforementioned problems in the background and existing technologies, this invention provides an adjustable shunt device with an adjustable opening size. The device is retracted to its minimum diameter and inserted into a delivery device with a sheath. The delivery device then releases the device to the appropriate position within the already constructed atrial septum. The device is then adjusted to a predetermined size via a steel cable structure connected externally. After implantation, relevant hemodynamic parameters are evaluated to determine the appropriate size of the device, and adjustments are made accordingly.

[0014] According to a first aspect of some embodiments of the present invention, an adjustable diversion device is provided, the adjustable diversion device may include a clamping assembly and an adjusting assembly for adjusting the distance between the clamping assemblies; the clamping assembly includes at least three clamping members, each clamping member having a first clamping arm, a second clamping arm and a connecting arm located between the first clamping arm and the second clamping arm; the adjusting assembly includes a connecting assembly that connects two adjacent connecting arms respectively, and an actuating assembly that allows the connecting assembly to move to adjust the distance between the clamping assemblies.

[0015] In some embodiments, the connecting assembly includes two first connectors and two movable blocks; the two movable blocks are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of each first connector is hinged to a connecting arm, and the other end is hinged to a movable block located on another connecting arm.

[0016] In some embodiments, the two first connectors are hinged at the middle.

[0017] In some embodiments, the connecting assembly includes a third connector and a fourth connector; one end of the third connector is hinged to a connecting arm, and the other end is hinged to the fourth connector; the other end of the fourth connector is hinged to another connecting arm.

[0018] In some embodiments, the first connector, the third connector, and the fourth connector are all hinged to the corresponding connecting arm via a hinge seat.

[0019] In some embodiments, the actuation component includes a screw, and the movable block is provided with a thread that engages with the screw and can be rotated and driven by the screw.

[0020] In some embodiments, one end of the screw is provided with a capture head that can be captured.

[0021] In some embodiments, the screw is arranged parallel to the connecting arm on which the threaded movable block is mounted, and the screw passes through the hinge seat on the connecting arm.

[0022] In some embodiments, the shaft at the hinge point between the hinge seat and the corresponding connecting arm is configured as a torsion spring.

[0023] In some embodiments, the first clamping arm includes a first clamping support arm and a second clamping support arm that bends and extends from the first clamping support arm, the end of the second clamping support arm having a bent section for being gripped, and the first clamping arm being connected to the connecting arm.

[0024] In some embodiments, the connecting assembly includes two third connectors and two fourth connectors; one end of each of the two third connectors is hinged to a connecting arm, and the other end is respectively hinged to the two fourth connectors; the other end of each of the two fourth connectors is hinged to another connecting arm.

[0025] In some embodiments, the connecting assembly includes a first connector, a second connector, and two movable blocks; the two movable blocks are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of the first connector is hinged to a connecting arm, and the other end is hinged to a movable block located on another connecting arm; one end of the second connector is hinged to a movable block on a connecting arm, and the other end is hinged to the middle of the first connector.

[0026] In some embodiments, a self-locking device is included to limit the sliding of the two movable blocks on the adjacent connecting arms.

[0027] In some embodiments, the self-locking device includes a self-locking nut disposed on the threaded movable block.

[0028] In some embodiments, the clamping assembly includes four clamping members. Therefore, the adjustable diversion device of the present invention, by embedding an adjustable diversion device in the diversion device and utilizing an actuation assembly for external control, can meet the requirement of adapting to all different sizes of diversions in practical use with a single specification. The device structure of the present invention has the following beneficial effects:

[0029] 1. The adjustable diversion device of the present invention includes an adjustment component that can adjust the distance between the clamping components, thereby adjusting the size of the interatrial septum opening, thus improving the adaptability of the adjustable diversion device.

[0030] 2. After the device is implanted in the appropriate location, the shunt effect can be judged by evaluating various hemodynamic indicators. Whether it is over-shunt or under-shunt, the size can be adjusted in either the forward or reverse direction through two adjustable directions.

[0031] 3. Once implantation is complete and the device is properly positioned, it exhibits good stability and can maintain its post-operative state without easily experiencing structural deformation such as expansion or stenosis. Attached Figure Description

[0032] To better understand and illustrate some embodiments of the present invention, the following description of the embodiments will be made in conjunction with the accompanying drawings, in which the same numerical designations indicate corresponding parts.

[0033] Figure 1 This is an exemplary structural diagram of an adjustable diversion device provided according to some embodiments of the present invention.

[0034] Figure 2 This is an exemplary schematic diagram of an adjustable diversion device provided according to some embodiments of the present invention in a first cross section.

[0035] Figure 3 This is an exemplary schematic diagram of an adjustable diversion device provided according to some embodiments of the present invention in the second cross section.

[0036] Figure 4 This is an exemplary schematic diagram of an adjustable diverter hinge seat provided according to some embodiments of the present invention.

[0037] Figure 5 This is an exemplary schematic diagram of an adjustable diversion device actuation assembly provided according to some embodiments of the present invention.

[0038] Figure 6 This is an exemplary schematic diagram of an adjustable diversion device connector provided according to Embodiment 1 of the present invention.

[0039] Figure 7 This is an exemplary schematic diagram of an adjustable diversion device connector provided according to Embodiment 2 of the present invention.

[0040] Figure 8 This is an exemplary schematic diagram of different states of the adjustable diversion device connector provided according to Embodiment 2 of the present invention.

[0041] Figure 9 This is an exemplary schematic diagram of an adjustable diversion device connector provided according to Embodiment 3 of the present invention.

[0042] Figure 10 This is an exemplary schematic diagram of different states of the adjustable diversion device connector provided according to Embodiment 3 of the present invention. Detailed Implementation

[0043] The following description with reference to the accompanying drawings is provided to facilitate a comprehensive understanding of various embodiments of the invention as defined by the claims and their equivalents. These embodiments include various specific details for ease of understanding, but these are merely exemplary. Therefore, those skilled in the art will understand that various changes and modifications can be made to the various embodiments described herein without departing from the scope and spirit of the invention. Furthermore, for the sake of brevity and clarity, descriptions of well-known functions and structures will be omitted.

[0044] The terms and phrases used in the following description and claims are not limited to their literal meaning, but are intended only to enable a clear and consistent understanding of the invention. Therefore, it will be understood by those skilled in the art that the description of various embodiments of the invention is provided for illustrative purposes only and is not intended to limit the invention as defined in the appended claims and their equivalents.

[0045] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of some embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0046] It should be noted that the terminology used in the embodiments of this invention is for the purpose of describing specific embodiments only and is not intended to limit the invention. The singular forms “a,” “an,” “an,” “the,” and “the” used in the embodiments of this invention and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used in this invention refers to and includes any or all possible combinations of one or more of the linked listed items. The expressions “first,” “second,” “first,” and “second” are used to modify the corresponding elements without regard to order or importance, and are merely used to distinguish one element from another, without limiting the corresponding element.

[0047] This invention provides an adjustable diversion device. To facilitate understanding of this invention, the embodiments will be described in detail below with reference to the accompanying drawings.

[0048] Figure 1 This is an exemplary structural diagram of an adjustable shunt device provided according to some embodiments of the present invention. Figure 1 As shown, in some embodiments, the adjustable diversion device may include a clamping assembly and an adjusting assembly for adjusting the distance between the clamping assemblies; the clamping assembly includes at least three clamping members 10, each clamping member having a first clamping arm, a second clamping arm, and a connecting arm located between the first clamping arm and the second clamping arm; the adjusting assembly includes a connecting assembly that connects two adjacent connecting arms respectively, and an actuating assembly 40 that allows the connecting assembly to move to adjust the distance between the clamping assemblies. In some embodiments, the clamping assembly includes four clamping members 10.

[0049] In some embodiments, the bent portions at both ends of the clamping member 10 include the first clamping arm 101 and the second clamping arm 102; the straight portion in the middle of the clamping member 10 is the connecting arm 103. Further, the first clamping arm 101 may include a first clamping support arm 1011 and a second clamping support arm 1012 extending from the first clamping support arm, the end of the second clamping support arm having a bent section 1013 for being gripped, and the first clamping arm 101 being connected to the connecting arm 103.

[0050] In some embodiments, the connecting assembly includes two first connecting members 50 and two movable blocks 32; the two movable blocks are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of each first connecting member is hinged to a connecting arm, and the other end is hinged to a movable block located on another connecting arm. The two first connecting members 50 are hinged at their middle portions. For example, the connecting assembly further includes a third connecting member 503 and a fourth connecting member 504; one end of the third connecting member is hinged to a connecting arm, and the other end is hinged to the fourth connecting member; the other end of the fourth connecting member is hinged to another connecting arm. The connection method of the third and fourth connecting members can be referred to... Figure 3 For example, the connecting assembly includes two third connecting members 503 and two fourth connecting members 504; one end of each of the two third connecting members is hinged to a connecting arm, and the other end is respectively hinged to the two fourth connecting members; the other end of each of the two fourth connecting members is hinged to another connecting arm. The first, third, and fourth connecting members are all hinged to their corresponding connecting arms via hinge seats 30. The connection method of the third and fourth connecting members can be referred to... Figure 9 In some embodiments, the shaft at the hinge point between the hinge seat 30 and the corresponding connecting arm can be replaced with a torsion spring. For example, the connecting assembly includes a first connecting member 50, a second connecting member 502, and two movable blocks 32; the two movable blocks are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of the first connecting member is hinged to a connecting arm, and the other end is hinged to a movable block located on the other connecting arm; one end of the second connecting member is hinged to a movable block on a connecting arm, and the other end is hinged to the middle of the first connecting member. The connection method of the first and second connecting members can be referred to... Figure 6 .

[0051] In some embodiments, the actuation assembly 40 includes a screw, and the movable block 32 is provided with a thread that engages with the screw and can be rotated by the screw. One end of the screw is provided with a gripping head that can be gripped. The screw is arranged parallel to the connecting arm on which the threaded movable block is mounted, and the screw passes through a hinge seat on the connecting arm. As an example, the screw controls the threaded movable block to slide along the connecting arm, causing the two first connecting members 50 to rotate around the central hinge, thereby increasing or decreasing the included angle between the two first connecting members on opposite sides of the connecting arm, which in turn decreases or increases the distance between the two adjacent connecting arms, thus adjusting the flow rate.

[0052] According to some embodiments of this application, the adjustable diversion device further includes a self-locking device for limiting the sliding of the two movable blocks on the adjacent connecting arms, thereby stabilizing the flow rate. For example, the self-locking device includes a self-locking nut, which may be disposed on the threaded movable block.

[0053] According to some embodiments of this application, at least three connecting arms are connected in series by the connecting member 50. The at least three connecting arms are evenly distributed and form a polygonal closed structure in a first cross-section, i.e., viewed from the direction of blood flow, where the connecting arm is a point and the connecting member is a line. The even distribution of the connecting arms can form an equilateral polygonal closed structure. The actuation component 40 adjusts the projected length of the connecting member 50 in the first cross-section to change the area of ​​the polygonal closed structure. In other words, the actuation component adjusts the distance between the clamping members, thereby regulating the flow rate. The polygonal closed structure can be determined by the number of clamping members 10, and can include, but is not limited to, triangles, quadrilaterals, pentagons, and hexagons. As an example, a quadrilateral structure is preferred. When the clamping component includes four clamping members 10, a quadrilateral closed structure is formed in the first cross-section. Figure 2 As shown.

[0054] Figure 2 This is an exemplary schematic diagram of an adjustable diversion device according to some embodiments of the present invention in a first cross-section. Figure 2 As shown, according to some embodiments of this application, the four connecting arms are connected in series by the first connecting member, the third connecting member, and the fourth connecting member, forming a quadrilateral closed structure 60 at a first cross-section where the connecting arm is a point and the connecting member is a line.

[0055] In some embodiments, the connecting arm serves as the vertex of the closed structure 60, and the connector 50 serves as the edge of the closed structure 60; the size of the closed structure 60 can be controlled by adjusting the projected length of the connector 50 in the first cross-section. As an example, by adjusting the projected length of the connector 50 in the first cross-section, the area of ​​the closed structure 60 can be changed, thereby achieving flow rate regulation.

[0056] Figure 3 This is an exemplary schematic diagram of an adjustable diversion device provided according to some embodiments of the present invention in a second cross section. Figure 3 As shown, according to some embodiments of this application, in the second cross section where the connecting arm is a line and the connector is a line, the projected length of the connector 50 in the first cross section is the perpendicular distance between two adjacent connecting arms in the second cross section; by adjusting the projected length of the connector 50 in the first cross section, the perpendicular distance between two adjacent connecting arms in the second cross section can be adjusted accordingly, thereby adjusting the area of ​​the closed structure 60 in the first cross section and realizing the regulation of the flow rate.

[0057] Figure 4 This is an exemplary schematic diagram of an adjustable diverter hinge mount provided according to some embodiments of the present invention. Figure 4As shown, according to some embodiments of this application, the hinge seat is a hollow structure, fitted onto the connecting arm, and the hinge seat can be fixedly connected to each of the two adjacent connecting arms. Figure 4 The pin 313 shown can be used to connect the hinge seat and the two first connecting members 50, and the two first connecting members 50 can rotate freely about the pin 313. As an example, the shaft at the hinge point between the hinge seat and the corresponding connecting arm can be set as a torsion spring.

[0058] In some embodiments, by rotating the two first connectors 50 around the pin 313, the projected length of the two first connectors 50 on the first cross section, that is, the vertical distance between the two adjacent connecting arms, can be adjusted, thereby adjusting the area of ​​the closed structure 60 on the first cross section and realizing the regulation of the flow rate.

[0059] Figure 5 This is an exemplary schematic diagram of an adjustable diversion device actuation assembly provided according to some embodiments of the present invention. Figure 5 As shown, according to some embodiments of this application, the actuation assembly 40 includes a screw 41, and one of the two movable blocks 32 is provided with a thread 42 that cooperates with the screw 41 and can be rotated and driven by the screw 41. One end of the screw 41 is provided with a grasping head that can be grasped. The screw 41 is arranged parallel to the connecting arm on which the threaded movable block 32 is mounted, and the screw 41 passes through the hinge seats 31 and 33 on the connecting arm and the threaded movable block 32.

[0060] In some embodiments, the threaded movable block 32 is slid along the connecting arm by the threaded engagement of the actuation component 40, so as to adjust the projected length of the connecting member 50 in the first cross section, that is, the vertical distance between the two adjacent connecting arms, thereby adjusting the area of ​​the closed structure 60 in the first cross section and realizing the regulation of the flow rate.

[0061] Example 1

[0062] Figure 6 This is an exemplary schematic diagram of an adjustable diversion device connector provided according to Embodiment 1 of the present invention. Figure 6 As shown, according to some embodiments of this application, the connecting assembly may include a first connector, a second connector, and two movable blocks 12 and n2; the two movable blocks are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of the first connector is hinged to a connecting arm through a hinge seat 11 and a pin 53, and the other end is hinged to a movable block n2 located on another connecting arm; one end of the second connector is hinged to a movable block 12 on a connecting arm, and the other end is hinged to the middle of the first connector through a pin 52.

[0063] According to some embodiments of this application, the connecting assembly may further include a third connector and a fourth connector; one end of the third connector is hinged to a connecting arm, and the other end is hinged to the fourth connector; the other end of the fourth connector is hinged to another connecting arm; the connection method of the third connector and the fourth connector can be described as follows: Figure 3 For example, the connecting assembly may further include two third connecting members and two fourth connecting members; one end of each of the two third connecting members is hinged to a connecting arm, and the other end is respectively hinged to the two fourth connecting members; the other end of each of the two fourth connecting members is hinged to another connecting arm; the connection method of the third connecting members and the fourth connecting members can refer to... Figure 9 .

[0064] In some embodiments, the connecting assembly between two adjacent connecting arms may consist only of a "Y"-shaped structure composed of a first connector and a second connector. For example, the connecting assembly between two adjacent connecting arms may include a "Y"-shaped structure composed of a first connector and a second connector, a "V"-shaped structure composed of a third connector and a fourth connector, or a "◇"-shaped structure composed of two third connectors and two fourth connectors.

[0065] In some embodiments, the connecting components between other adjacent connecting arms may be the same as or different from the connecting members between the two adjacent connecting arms. As an example, the connecting components between other adjacent connecting arms may consist only of a "V"-shaped structure composed of a third connecting member and a fourth connecting member, or the connecting components between other adjacent connecting arms may include a "◇" structure composed of two third connecting members and two fourth connecting members, etc.

[0066] Example 2

[0067] Figure 7 This is an exemplary schematic diagram of an adjustable diversion device connector provided according to Embodiment 2 of the present invention. Figure 7 As shown, according to some embodiments of this application, the connecting assembly includes two first connecting members 50 and two movable blocks 32; the two movable blocks 32 are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of each first connecting member 50 is hinged to a connecting arm through a hinge seat 31 and a pin 53, and the other end is hinged to a movable block 32 located on another connecting arm. The middle portions of the two first connecting members 50 are hinged through pins 52.

[0068] According to some embodiments of this application, the connecting assembly may further include a third connector 503 and a fourth connector 504; one end of the third connector is hinged to a connecting arm via a hinge seat 33, and the other end is hinged to the fourth connector via a pin 54; the other end of the fourth connector is hinged to another connecting arm via a hinge seat 33. The connection method of the third connector and the fourth connector can be referred to... Figure 3 , Figure 7 , Figure 8 .

[0069] In some embodiments, the connecting assembly between two adjacent connecting arms may include an "X"-shaped structure composed of two first connecting members, and a "V"-shaped structure composed of a third connecting member and a fourth connecting member. The connection method of the first, third, and fourth connecting members can be described in [reference needed]. Figure 3 , Figure 7 , Figure 8 .

[0070] In some embodiments, the connecting components between other adjacent connecting arms may be the same as or different from the connectors between the two adjacent connecting arms. For example, the connecting components between other adjacent connecting arms may consist only of an "X" shape formed by two first connectors. As another example, the connecting components between other adjacent connecting arms may consist only of a "V" shape formed by a third connector and a fourth connector. Yet another example, the connecting components between other adjacent connecting arms may consist only of a "◇" shape formed by two third connectors and two fourth connectors, etc.

[0071] Figure 8 This is an exemplary schematic diagram showing different states of the adjustable diversion device connector provided according to Embodiment 2 of the present invention. Figure 8 As shown, according to some embodiments of this application, the actuation component controls the two movable blocks to slide along the connecting arm, causing the connector to rotate around the pin, thereby increasing the included angle of the connector with opposite sides of the connecting arm in the second cross-section (e.g., Figure 8 The angle shown is between the connecting arms, with the connecting arm as the opposite side. Figure 7 As shown, the angle between the connecting arms (with the connecting arms as opposite sides) increases, causing the perpendicular distance between the connecting arms to decrease, thereby reducing the cross-section of the closed structure 60 and reducing the flow rate.

[0072] In some embodiments, the actuation component controls the two movable blocks to slide along the connecting arm (including the positive and negative directions), causing the connector to rotate around the pin. In the second cross section, the included angle between the connectors with the connecting arm as opposite sides increases or decreases, thereby decreasing or increasing the distance between the connecting arms and thus decreasing or increasing the cross section of the closed structure, for the purpose of regulating the flow rate.

[0073] Example 3

[0074] Figure 9 This is an exemplary schematic diagram of an adjustable diversion device connector provided according to Embodiment 3 of the present invention. Figure 9 and Figure 10 As shown, according to some embodiments of this application, the connecting assembly includes two first connecting members 50 and two movable blocks 32; the two movable blocks 32 are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of each first connecting member 50 is hinged to a connecting arm through a hinge seat 31 and a pin 51, and the other end is hinged to a movable block 32 located on another connecting arm. The middle portions of the two first connecting members 50 are hinged through pins 52.

[0075] According to some embodiments of this application, the connecting assembly includes two third connecting members 503 and two fourth connecting members 504; one end of each of the two third connecting members is hinged to a connecting arm via a hinge seat 33, and the other end is respectively hinged to the two fourth connecting members via two pins 54; the other end of each of the two fourth connecting members is hinged to another connecting arm via a hinge seat 33. The connection method of the third and fourth connecting members can be referred to... Figure 9 , Figure 10 .

[0076] In some embodiments, the connecting assembly between two adjacent connecting arms may include an "X"-shaped structure composed of two first connecting members, and a "◇"-shaped structure composed of two third connecting members and two fourth connecting members. The connection method of the first, third, and fourth connecting members can be described in [reference needed]. Figure 9 , Figure 10 .

[0077] In some embodiments, the connecting components between other adjacent connecting arms may be the same as or different from the connectors between the two adjacent connecting arms. For example, the connecting components between other adjacent connecting arms may consist only of an "X" shape formed by two first connectors. As another example, the connecting components between other adjacent connecting arms may consist only of a "V" shape formed by a third connector and a fourth connector. Yet another example, the connecting components between other adjacent connecting arms may consist only of a "◇" shape formed by two third connectors and two fourth connectors, etc.

[0078] In some embodiments, by setting such as Figure 9 The two third connectors and two fourth connectors shown form a good supporting force at the hinge seat 33 end of the two adjacent connecting arms, which can better maintain the hole in the middle of the closed structure 60 and better maintain the flow rate.

[0079] Figure 10This is an exemplary schematic diagram showing different states of the adjustable diversion device connector provided according to Embodiment 3 of the present invention. Figure 10 As shown, according to some embodiments of this application, the actuation component controls the two movable blocks to slide along the connecting arm, causing the connector to rotate around the pin, thereby increasing the included angle of the connector with opposite sides of the connecting arm in the second cross-section (e.g., Figure 10 The angle shown is between the connecting arms, with the connecting arm as the opposite side. Figure 9 As shown, the angle between the connecting arms (with the connecting arms as opposite sides) increases, causing the perpendicular distance between the connecting arms to decrease, thereby reducing the cross-section of the closed structure 60 and reducing the flow rate.

[0080] In some embodiments, the actuation component controls the two movable blocks to slide along the connecting arm (including the positive and negative directions), causing the connector to rotate around the pin. In the second cross section, the included angle between the connectors with the connecting arm as opposite sides increases or decreases, thereby decreasing or increasing the distance between the connecting arms, and further decreasing or increasing the cross section of the closed structure, for the purpose of regulating the flow rate.

[0081] According to some embodiments of this application, the adjustable diversion device may further include a self-locking device for limiting the sliding of the two movable blocks on adjacent connecting arms, thereby controlling the area of ​​the closed structure to remain constant for stabilizing the flow rate. In some embodiments, the self-locking device includes a self-locking nut, which may be disposed on the threaded movable block.

[0082] According to some embodiments of this application, the connecting structure is adjusted from a "V" shape consisting of a third connecting member and a fourth connecting member to a "◇" structure consisting of two third connecting members and two fourth connecting members. This can form a better supporting force at the end of the two adjacent connecting arms connected by the two third connecting members and the two fourth connecting members, better maintain the hole in the middle of the closed structure, and better maintain blood flow.

[0083] According to some embodiments of this application, a support is provided, including the aforementioned adjustable diversion device, which is used to adjust the flow rate of the support and the hydraulic differential.

[0084] According to some embodiments of this application, the adjustable shunt device has the following beneficial effects: during actual use, the size of the closed structure 60 can be adjusted in two directions, and the movable block can slide in two directions, causing the area of ​​the closed structure 60 in the first cross-section to increase or decrease. The area of ​​the closed structure 60 determines the flow rate (e.g., blood flow rate) and is also used to regulate the blood pressure difference between the left and right atria. When the flow rate is insufficient, the shunt effect of the right atrium on the left atrium can be increased by increasing the area of ​​the closed structure 60; when the shunt is too large, the shunt effect of the right atrium on the left atrium can be reduced by decreasing the area of ​​the closed structure 60. In actual use, after the adjustable shunt device is implanted into the interatrial septum, relevant hemodynamic indicators can be observed and judged, and the adjustable shunt device can be adjusted accordingly until the optimal effect is achieved. It should be noted that the area of ​​the closed structure 60 of the adjustable diversion device can be adjusted by the actuation component 40, and the adjustment is reversible; and the adjustable diversion device as a whole has a self-locking characteristic. When the closed structure 60 is adjusted to a certain size, the adjustable diversion device can maintain the area of ​​the closed structure 60 and keep it unchanged, so that it can provide a continuous and stable diversion effect.

[0085] It should be noted that the above description of the adjustable diversion device is for ease of description only and should not be construed as limiting the invention to the scope of the embodiments described. It is understood that those skilled in the art, based on the principle of this device, may arbitrarily combine the various structures, or combine substructures with other structures, without departing from the principle, to make various modifications and changes in form and detail to the function of implementing the above-described device and operation. For example, the adjustable diversion device may further include a self-locking device, etc. Such modifications are all within the protection scope of this invention.

[0086] In summary, the adjustable diversion device of the present invention includes an adjustment component that can adjust the distance between the clamping components, thereby adjusting the size of the interatrial septum opening, thus improving the adaptability of the adjustable diversion device.

[0087] It should be noted that the above embodiments are merely examples, and the present invention is not limited to such examples, but various variations are possible.

[0088] It should be noted that, in this specification, the terms "comprising," "including," or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0089] The above-disclosed embodiments are merely some preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. Those skilled in the art will understand that implementing all or part of the structures of the above embodiments and making equivalent changes in accordance with the claims of the present invention still fall within the scope of the present invention.

Claims

1. An adjustable diversion device, characterized in that, include: Clamping components and adjusting components that can adjust the distance between the clamping components; The clamping assembly includes at least three clamping members, each clamping member having a first clamping arm, a second clamping arm, and a connecting arm located between the first clamping arm and the second clamping arm; the first clamping arm includes a first clamping support arm and a second clamping support arm that bends and extends from the first clamping support arm, the end of the second clamping support arm having a bent section for being grasped, and the first clamping arm being connected to the connecting arm; The adjustment assembly includes a connecting assembly that connects two adjacent connecting arms respectively, and an actuating assembly that allows the connecting assembly to move so as to adjust the distance between the clamping assemblies; the connecting assembly includes two first connecting members and two movable blocks; the two movable blocks are respectively disposed on two adjacent connecting arms and can slide along the connecting arms; one end of each first connecting member is hinged to a connecting arm, and the other end is hinged to a movable block located on the other connecting arm; It also includes a self-locking device for limiting the sliding of the two movable blocks on the adjacent connecting arms; the self-locking device includes a self-locking nut, which is disposed on the threaded movable block. An adjustable shunt device can be implanted into the interatrial septum. The adjustable shunt device can adjust the distance between the clamping components by adjusting the components, thereby adjusting the size of the interatrial septum opening.

2. The adjustable diversion device according to claim 1, characterized in that: The two first connecting members are hinged at the middle.

3. The adjustable diversion device according to claim 1, characterized in that: The connecting assembly includes a third connector and a fourth connector; one end of the third connector is hinged to a connecting arm, and the other end is hinged to one end of the fourth connector; the other end of the fourth connector is hinged to another connecting arm.

4. The adjustable diversion device according to claim 3, characterized in that: The first connector, the third connector, and the fourth connector are all hinged to the corresponding connecting arm via hinge seats.

5. The adjustable diversion device according to claim 4, characterized in that: The actuation assembly includes a screw, and the threaded movable block is provided with the thread that engages with the screw and can be rotated and driven by the screw.

6. The adjustable diversion device according to claim 5, characterized in that: One end of the screw is equipped with a capture head that can be captured.

7. The adjustable diversion device according to claim 5, characterized in that: The screw is arranged parallel to the connecting arm on which the threaded movable block is installed, and the screw passes through the hinge seat on the connecting arm.

8. The adjustable diversion device according to claim 4, characterized in that: The shaft at the hinge point between the hinge seat and the corresponding connecting arm is configured as a torsion spring.

9. The adjustable diversion device according to claim 3, characterized in that: The connecting assembly includes two third connectors and two fourth connectors; one end of each of the two third connectors is hinged to a connecting arm, and the other end is hinged to each of the two fourth connectors; the other end of each of the two fourth connectors is hinged to another connecting arm.

10. The adjustable diversion device according to claim 1, characterized in that, The clamping assembly includes four clamping members.

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