Shunt device

Abstract

The present application provides a shunt device, comprising a shunt member and a flow regulating mechanism. The shunt member comprises a body and an inlet and an outlet located at two ends of the body, and the shunt member defines a shunt passage for pressurized fluid; the flow regulating mechanism is connected to the shunt member, and the flow regulating mechanism is used for regulating the flow of the pressurized fluid flowing through the shunt passage; the flow regulating mechanism comprises a blocking portion having a variable form, and the blocking portion is configured such that when the fluid pressure at the inlet of and / or inside the shunt member is less than the fluid pressure outside the flow regulating mechanism, the blocking portion is driven by the fluid pressure outside the flow regulating mechanism to radially collapse, so that the flow regulating mechanism partially closes the shunt passage.

Description

Diverter device Technical Field

[0001] The present application relates to the field of interventional medical devices, and in particular to a shunt device. Background Art

[0002] Heart failure is a clinical syndrome caused by abnormal ventricular filling and ejection function. The main manifestations of heart failure include dyspnea, fatigue, and fluid retention (pulmonary congestion, systemic congestion, and peripheral edema). Heart failure can be divided into three categories: heart failure with reduced ejection fraction, heart failure with mildly reduced ejection fraction, and heart failure with preserved ejection fraction. In patients with chronic heart failure with preserved ejection fraction and reduced ejection fraction, persistently elevated left atrial pressure is the main cause of pulmonary congestion, and 90% of heart failure patients are hospitalized for this reason.

[0003] Atrial shunt surgery is a procedure to improve left atrial hypertension. It involves creating a hole in the atrial septum to divert blood flow from the left atrium to the right atrium, thereby reducing the burden on the left atrium. An atrial shunt, by limiting the diameter of the hole in the atrial septum, creates a pathway between the left and right atria, effectively reducing left atrial pressure, relieving pulmonary congestion, and dyspnea. After implantation of the atrial shunt, blood does not flow back from the right atrium to the left atrium when left atrial pressure exceeds right atrial pressure. When right atrial pressure exceeds left atrial pressure for certain periods of time (e.g., during breath-holding or Valsalva maneuvers), or when the pressures of the two atria are close, undesirable backflow can occur, shunting blood from the right atrium to the left atrium, allowing small "particles" (such as small blood clots) in the venous circulation to enter the left atrium. This can increase the risk of migraines or paradoxical embolism, as well as increase left atrial filling and reduce blood oxygen levels.

[0004] Therefore, some existing atrial shunt designs incorporate a one-way valve structure that opens only when the left atrial pressure is higher than the right atrial pressure, allowing blood to flow from the left atrium to the right atrium. It completely closes when the left atrial pressure is lower than the right atrial pressure, preventing blood from flowing back from the right atrium to the left atrium. However, the inventors have discovered that this design can lead to new problems in actual use. The one-way valve structure tends to fail after a period of time in the body and no longer opens in response to the pressure differential, causing the shunt to fail.

[0005] Summary of the Invention

[0006] In view of this, the present application provides a diversion device for solving one or more problems in the prior art.

[0007] In a first aspect, a diverter device is provided for diverting a pressure fluid, comprising a diverter and a flow regulating mechanism. The diverter comprises a main body and an inlet and an outlet at either end of the main body, the diverter defining a diverter channel for the pressure fluid; a flow regulating mechanism is connected to the diverter, the flow regulating mechanism being configured to regulate the flow of the pressure fluid flowing through the diverter channel; the flow regulating mechanism comprises a morphologically variable blocking portion, the blocking portion being configured to be driven radially by the fluid pressure outside the flow regulating mechanism when the fluid pressure at the inlet and / or inside the diverter is less than the fluid pressure outside the flow regulating mechanism.

[0008] In a possible implementation, the flow regulating mechanism never completely closes the diversion channel.

[0009] In one possible implementation, the blocking portion is used to change the flow cross-sectional area of ​​the diverter channel. The flow regulating mechanism has a first state and a second state. In the first state, the blocking portion is in a retracted state so that the diverter channel has a first flow cross-sectional area. In the second state, the blocking portion is in an open state so that the diverter channel has a second flow cross-sectional area. The first flow cross-sectional area is greater than zero and smaller than the second flow cross-sectional area. The blocking portion is configured to be driven by the fluid pressure outside the flow regulating mechanism to radially retract when the fluid pressure at the inlet and / or inside the diverter is lower than the fluid pressure outside the flow regulating mechanism so that the flow regulating mechanism is in the first state.

[0010] In one possible implementation, when the blocking portion is in a retracted form, the blocking portion is deformed into a concave state, and when the blocking portion is in an open form, the blocking portion is deformed into a bowed state; the blocking portion is configured to be driven by the fluid pressure outside the flow regulating mechanism to radially concave so that the flow regulating mechanism is in the first state when the fluid pressure at the inlet and / or inside the diverter is less than the fluid pressure outside the flow regulating mechanism.

[0011] In combination with the above possible implementations, in another possible implementation, the flow regulating mechanism includes an adjusting soft cylinder connected to the diverter, and the cylinder wall of the adjusting soft cylinder includes a first part distributed circumferentially, and the first part is configured to be radially concave or arched, and the first part is a blocking part.

[0012] In combination with the above possible implementation methods, in another possible implementation method, the regulating tube also includes a second part, which is distributed circumferentially apart from the first part; the flow regulating mechanism also includes a shaping frame, which supports a predetermined part of the regulating tube to keep the second part in a bowed state and allows the first part to be controllably concave or bowed under the restriction of the shaping frame.

[0013] In combination with the above possible implementation methods, in another possible implementation method, the shaping frame includes a plurality of fixing parts, one end of the fixing part is connected to the diverter and the other end extends axially, and the plurality of fixing parts are distributed circumferentially of the adjusting soft cylinder; the cylinder wall of the adjusting soft cylinder includes a plurality of first parts corresponding to the plurality of fixing parts and a plurality of second parts, the first part is arranged between two circumferentially adjacent fixing parts, and the second part is fixed to the fixing part and has a predetermined width, so that the parts of two adjacent first parts close to the fixing part cannot contact each other.

[0014] In combination with the above possible implementation manner, in another possible implementation manner, the width of the fixing portion is consistent with the width of the second portion, and the adjustment soft tube is arranged on the inner side and / or the outer side of the fixing portion.

[0015] In combination with the above possible implementation methods, in another possible implementation method, the fixing portion includes a first vertical rod and a second vertical rod, and there is a predetermined distance between the first vertical rod and the second vertical rod. One end of the first vertical rod and one end of the second vertical rod are connected to the diverter, and the other end of the first vertical rod and the other end of the second vertical rod gradually approach each other along their respective extension directions.

[0016] In combination with the above possible implementation methods, in another possible implementation method, the fixing portion also includes a horizontal rod connecting the other end of the first vertical rod and the other end of the second vertical rod, a reinforcing rib arranged between the first vertical rod and the second vertical rod, and a ring frame connecting one end of the first vertical rod and one end of the second vertical rod.

[0017] In combination with the foregoing possible implementation manner, in another possible implementation manner, the multiple fixing portions include three fixing portions.

[0018] In combination with the above possible implementation manner, in another possible implementation manner, the three fixing portions are evenly distributed in the circumference of the adjusting flexible cylinder.

[0019] In combination with the above possible implementation manner, in another possible implementation manner, a hanging ear is provided at the end of the fixing portion, and the hanging ear is used to connect to a predetermined structure in the interventional catheter.

[0020] In combination with the above possible implementation methods, in another possible implementation method, the edge profile of the first part is a curve that is concave toward the inlet, the edge profile of the second part is a curve that is smoothly connected to the edge profile of the first part, and the axial size of the part of the first part away from the fixed part is smaller than the size of the part close to the fixed part.

[0021] In combination with the above possible implementation methods, in another possible implementation method, the edge profile of the first part is a curve and has a minimum length dimension at the middle position, the edge profile of the second part is a curve connected to the edge profile of the first part and has a maximum length dimension at the middle position, and the ratio of the minimum length dimension to the maximum length dimension ranges from 0.3 to 1.

[0022] In combination with the above possible implementation manner, the ratio of the minimum length dimension to the diameter of the adjusting flexible cylinder ranges from 0.5 to 3.

[0023] In combination with the above possible implementation methods, in another possible implementation method, there are multiple first parts, and when the multiple first parts are recessed, they do not completely contact the center of the diversion channel and divide the diversion channel into multiple sub-channels, and the multiple sub-channels are located at the edge of the diversion channel.

[0024] In combination with the foregoing possible implementation manner, in another possible implementation manner, there are multiple first parts, and the multiple first parts do not contact each other when recessed and do not form a slit.

[0025] In combination with the above possible implementation manner, in another possible implementation manner, the diverter and the shaping frame are metal frames integrally wound from wire materials, and any cross section of the metal frame is a non-closed profile.

[0026] In combination with the above possible implementations, in another possible implementation, the shaping frame is integrally formed with the blocking portion or connected to the blocking portion as a separate part, and the separate part is cut from a metal tube or bent from a metal wire.

[0027] In combination with the above possible implementation methods, in another possible implementation method, the main body includes a bracket and a diverter tube arranged on the inner surface and / or outer surface of the bracket, the diverter tube and the regulating tube are formed integrally, the diverter part is connected to the flow regulating mechanism at the outlet, the main body and the diverter tube form the first section of the diverter channel, and the regulating tube forms the second section of the diverter channel.

[0028] In combination with the above possible implementations, in another possible implementation, the bracket includes a clamping device, and the clamping device includes multiple pairs of first clamping arms and second clamping arms, and the first clamping arms and the second clamping arms are respectively extended from the diversion part of the bracket.

[0029] In combination with the above possible implementation manner, in another possible implementation manner, the first clamping arm and the second clamping arm are respectively extended from the diversion portion of the bracket and gradually approach each other.

[0030] In combination with the above possible implementations, in another possible implementation, each of the first clamping arms and / or each of the second clamping arms is composed of two extended wire segments and one annular wire segment, and both ends of the annular wire segment are respectively connected to one of the extended wire segments.

[0031] In combination with the above possible implementations, in another possible implementation, the flow regulating mechanism further includes a shaping frame, which includes a plurality of elastic guide frames, which connect the blocking portion and keep the blocking portion in a retracted shape in an initial state.

[0032] In combination with the above possible implementations, in another possible implementation, one end of the elastic guide frame is connected to the main body, and the other end forms an elastic cantilever in the axial direction, and the other end is closer to the center of the diversion channel than the one end.

[0033] In combination with the above possible implementation methods, in another possible implementation method, the flow regulating mechanism includes an adjusting soft cylinder connected to the diverter, and the cylinder wall of the adjusting soft cylinder includes a first part and a second part distributed in the circumferential direction, and the second part and the first part are distributed circumferentially and separated from each other; the first part is configured to be able to be recessed or arched in the radial direction, the first part is the blocking part, and the elastic guide frame enables the second part to always maintain a arched state.

[0034] In combination with the above possible implementation manner, in another possible implementation manner, the elastic guide frame is formed by bending a metal wire, and can reach a state parallel to the central axis of the diverter when subjected to a radially outward force.

[0035] In combination with the above possible implementations, in another possible implementation, the shaping frame and the blocking portion are integrally formed or connected to the blocking portion as a separate part, and the separate part is cut from a metal tube or bent from a metal wire.

[0036] In combination with the above possible implementation manner, in another possible implementation manner, the number of the blocking parts is multiple, and the initial state of the flow regulating mechanism is the first state or the second state.

[0037] In combination with the above possible implementation methods, in another possible implementation method, the diverter also includes a diverter cylinder arranged on the inner surface and / or outer surface of the main body, the diverter cylinder and the adjustment cylinder are formed integrally, and the diverter is connected to the flow regulating mechanism at the outlet, the main body and the diverter cylinder form the first section of the diverter channel, and the adjustment cylinder forms the second section of the diverter channel.

[0038] In combination with the above possible implementation manner, in another possible implementation manner, the diverter device further includes a monitoring device, and the monitoring device is connected side by side with the diverter element.

[0039] The shunt device provided by the present application has a flow regulating mechanism disposed on a shunt channel defined by a shunt member, and can switch between a first state and a second state under the action of a pressure fluid passing through the shunt channel, thereby limiting the flow of the pressure fluid in an undesirable flow direction and allowing the pressure fluid to pass in a desired flow direction. In the present application, the first state corresponds to a state in which the flow regulating mechanism is in a flow-restricting state, and the second state corresponds to a state in which the flow regulating mechanism is in a flow-permitting state. Unlike the fully closed design of a one-way valve structure in the prior art to prevent backflow, the flow regulating mechanism of the present application will never completely close the flow channel. While taking into account that minor backflow will not affect the normal physiological functions of the human body, the incompletely closed design effectively avoids the failure problem caused by neointimal hyperplasia, ensures the proper shunt function of the shunt, reduces the probability of patients suffering from heart failure due to shunt failure, and effectively improves the survival rate of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments.

[0041] It should be understood that the following drawings only illustrate certain embodiments of the present application and should not be considered as limiting the scope.

[0042] It should also be understood that the same or similar reference numerals are used throughout the drawings to identify the same or similar elements.

[0043] It should also be understood that the drawings are merely schematic and that the sizes and proportions of elements in the drawings are not necessarily accurate.

[0044] FIG1 is a schematic structural diagram of a flow diversion device according to an embodiment of the present application.

[0045] FIG2 is a schematic diagram of the end surface structure of the outlet side of the flow regulating mechanism in FIG1 .

[0046] FIG3 is a schematic diagram of a flow regulating mechanism in a second state in an optional embodiment.

[0047] FIG4 is a schematic diagram of the flow regulating mechanism in FIG3 in a first state.

[0048] FIG5 is a schematic structural diagram of a flow diversion device according to another embodiment of the present application, wherein the flow regulating mechanism is in a first state.

[0049] FIG6 a is a schematic structural diagram of a flow diversion device according to another embodiment of the present application, wherein the flow regulating mechanism is in a first state.

[0050] FIG. 6 b is a cross-sectional view taken along line BB in FIG. 6 a .

[0051] FIG. 7 is a schematic structural diagram of the flow regulating mechanism of the diverter device shown in FIG. 6 a in a second state.

[0052] FIG8 a is a schematic structural diagram of a flow regulating mechanism in an optional embodiment.

[0053] FIG8 b is a schematic structural diagram of a flow regulating mechanism in another optional embodiment.

[0054] FIG8c is a schematic structural diagram of a flow regulating mechanism in another optional embodiment.

[0055] FIG8 d is a schematic structural diagram of a flow regulating mechanism in another optional embodiment.

[0056] FIG9 is a schematic structural diagram of a diversion device according to another embodiment of the present application.

[0057] FIG10 is a schematic structural diagram of a diversion device according to another embodiment of the present application.

[0058] FIG11 is a schematic diagram of the three-dimensional structure of the diversion device shown in FIG10 .

[0059] FIG12 is a schematic structural diagram of the second portion of the regulating hose of the diverter device shown in FIG11 when the flow regulating mechanism is in the first state.

[0060] FIG13 is a schematic structural diagram of a diversion device according to another embodiment of the present application.

[0061] Explanation of reference numerals: 10 - diverter, 20 - sensor; 100 - diverter, 110 - bracket, 111 - first clamping arm, 112 - second clamping arm, 113 - inlet, 114 - outlet, 120 - diverter cartridge; 200, 200a - flow regulating mechanism, 210, 210a, 210f - shaping frame, 211, 211a - fixing portion, 213, 213a, 213f-first vertical rod, 214, 214a, 214f-second vertical rod, 215-horizontal rod, 216-hanging ear, 217-reinforcement rib, 220, 220a, 220f-adjusting soft tube, 221, 221a, 221b, 221c, 221d, 221e, 221f-first part, 222, 222a, 222b, 222c, 222d, 222e, 222f-second part, 230-sub-channel; 211b, 211c, 211d, 211e, 211f-elastic guide frame. DETAILED DESCRIPTION

[0062] The following is an exemplary description of the embodiments of the present application with reference to the accompanying drawings. It should be understood that the present application can be implemented in a variety of ways and should not be construed as being limited to the embodiments described herein. The embodiments described herein are only for a more thorough and complete understanding of the present application.

[0063] It should be understood that the term "including" and its variations used in this application are open inclusions, that is, "including but not limited to". The term "according to" means "at least in part according to", and the term "plurality" means "two or more".

[0064] It should be understood that although the terms “first” or “second” etc. are used in the present application to describe various elements, these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

[0065] An embodiment of the present application provides a shunt device for shunting a pressure fluid, such as being arranged at the atrial septum of the heart to guide part of the blood in the left atrium to the right atrium. The "pressure fluid" here refers to a fluid driven by a pressure difference, which is blood in the embodiment. The shunt device includes a shunt piece and a flow regulating mechanism. The shunt piece includes a main body and an inlet and an outlet located at both ends of the main body. The flow regulating mechanism is connected to the shunt piece. The shunt piece defines a shunt channel for the pressure fluid. The flow regulating mechanism is used to regulate the flow of the pressure fluid flowing through the shunt channel. When the pressure of the left atrium is higher than that of the right atrium, the flow cross-sectional area of ​​the shunt channel increases in response to the increase in the pressure of the fluid until it reaches the maximum flow cross-sectional area. When the pressure of the right atrium is higher than that of the left atrium, the flow cross-sectional area of ​​the shunt channel becomes smaller, thereby limiting the flow of fluid from the outlet to the inlet.

[0066] Furthermore, the flow regulating mechanism includes a variable-shape blocking portion, which is configured to change the flow cross-sectional area of ​​the diverter channel by changing its shape. "Flow cross-sectional area" herein refers to the cross-sectional area of ​​the narrowest point in the diverter channel, such as the area of ​​the opening formed by the end edge profile of the flow regulating mechanism. The flow regulating mechanism has a first state and a second state. In the first state, the blocking portion is in a retracted configuration, providing the diverter channel with a first flow cross-sectional area. In the second state, the blocking portion is in an open configuration, providing the diverter channel with a second flow cross-sectional area, wherein the first flow cross-sectional area is greater than zero and less than the second flow cross-sectional area. The blocking portion is configured such that, when the fluid pressure at the diverter inlet and / or within the diverter is less than the fluid pressure outside the flow regulating mechanism, the blocking portion is driven radially to retract radially, placing the flow regulating mechanism in the first state. When the fluid pressure at the diverter inlet and / or within the diverter is greater than the fluid pressure outside the flow regulating mechanism, the blocking portion is driven radially to open radially, placing the flow regulating mechanism in the second state, by the fluid pressure at the diverter inlet and / or within the diverter. In the first state, the blocking portion is retracted, partially blocking the diversion channel, allowing only a small amount of fluid to flow from the outlet to the inlet. Because the blocking portion does not completely close, it effectively avoids the problem of tissue hyperplasia causing the blocking portion to become stuck and unable to open to the second state. In various embodiments, the initial state of the flow control mechanism can be either the first state or the second state.

[0067] Refer to Figures 1 and 2. Figure 1 is a schematic structural diagram of a diverter device according to an embodiment of the present application. Figure 2 is a schematic structural diagram of the end face of the diverter device at the outlet side in Figure 1.

[0068] The shunt device includes a shunt member 100 and a flow regulating mechanism 200. The shunt member 100 includes a main body formed by a support 110 and a shunt tube 120. The support 110 is a cylindrical mesh frame formed by winding, braiding, or cutting an elastic metal wire. Multiple pairs of clamping devices, consisting of a first clamping arm 111 and a second clamping arm 112, are provided on the periphery of the support 110 to clamp the atrial septum. The shunt tube 120 is formed by a coating applied to the inner and / or outer surfaces of the support 110. Preferably, the coating is made of a polymer material, such as a polytetrafluoroethylene film. The two ends of the shunt member 100 are respectively an inlet 113 and an outlet 114 (in this embodiment, the outlet 114 of the shunt member 100 is directly and seamlessly connected to the inlet of the flow regulating mechanism 200, so only their approximate positions are shown in the figure). The flow regulating mechanism 200 also has an inlet and an outlet. The flow regulating mechanism 200 is connected to the shunt member 100 at the outlet 114, and its inlet is connected to the outlet 114. When shunt 100 is installed in the atrial septum of the heart, inlet 113 is located in the left atrium, while outlet 114 and flow regulating mechanism 200 are located in the right atrium. When the left atrial pressure is greater than the right atrial pressure, some blood can flow through shunt 100 to the right atrium. Flow regulating mechanism 200 can prevent blood from entering the left atrium when the right atrial pressure is greater than that of the left atrium.

[0069] In this embodiment, the diverter 100 defines a diverter channel for the pressurized fluid. The bracket 110 and the diverter tube 120 form the first section of the diverter channel. The flow regulating mechanism 200 includes a shaped frame 210 and an adjustable tube 220. The shaped frame 210 and the adjustable tube 220 combine to form the second section of the diverter channel. The second section is a channel with a variable flow cross-sectional area. This channel is connected in series at the outlet 114 of the diverter 100 and communicates with the first section, thereby enabling the flow regulating mechanism 200 to restrict the fluid flowing through the outlet 114.

[0070] The shaping frame 210 includes an annular frame and two fixing portions 211. One end of the annular frame is used to connect the diverter 100, and the other end is connected to the two fixing portions 211 in radial symmetry. The fixing portion 211 extends parallel to the axis of the annular frame. The fixing portion 211 is roughly N-shaped and includes a first vertical rod 213, a second vertical rod 214 and a cross bar 215. One end of the first vertical rod 213 and the second vertical rod 214 is connected to the annular frame, and the other end is connected to the cross bar 215. The first vertical rod 213 and the second vertical rod 214 can also be connected by a reinforcing rib 217. The reinforcing rib 217 can improve the structural stability of the shaping frame 210 and prevent the shaping frame 210 from being damaged and unable to fully recover when being pressed onto the conveyor. The two fixing portions 211 face each other, and the spacing between them is equal to the diameter D of the annular frame and the regulating flexible cylinder 220.

[0071] Preferably, as shown in Figure 1, the tops of two fixing parts 211 are also provided with lugs 216. Lugs 216 are used for diverter device to be connected on the corresponding structure in the interventional catheter, so that diverter device is controlledly released to the target site.Shaping frame 210 can cut the metal cylinder made of elastic material to form, so that when observing from the end face of flow regulating mechanism 200, shaping frame 210 is annular as a whole. The end face forward projection of annular frame can be a complete annular structure, can also be a part on a complete annular structure, as shown in Figure 1, annular frame comprises two parts on the complete annular structure, and the two ends of a part are connected with the first vertical rod 213 respectively, and the two ends of another part are connected with the second vertical rod 214 respectively.

[0072] Preferably, the regulating tube 220 is a cylindrical structure formed of a film. In this embodiment, the regulating tube 220 and the diverter tube 120 are cylindrical structures formed of the same film. In some alternative embodiments, the diverter tube 120 and the regulating tube 220 can be two separate tubes connected together, such as by sewing / bonding them together at the dotted line in Figure 1. The regulating tube 220 is disposed on the inner and / or outer surface of the shaping frame 210, and the portion of the regulating tube 220 that contacts the shaping frame 210 is connected to the shaping frame 210.

[0073] The regulating tube 220 includes a first portion 221 and a second portion 222. The first portion 221 is located between the two fixing portions 211, and the second portion 222 is located between the first vertical rod 213 and the second vertical rod 214. The second portion 222 is fixed to the fixing portion 211 and has a predetermined width W, so that the connection between the second portion 222 and the first vertical rod 213 and the connection between the second portion 222 and the second vertical rod 214 do not intersect, and the portions of the two first portions 221 near the fixing portion 211 do not contact each other. The above arrangement enables the flow regulating mechanism 200 to have a first state and a second state and to switch between the two. The first state refers to the flow regulating mechanism 200 being in a "restricted flow" state, and the second state refers to the flow regulating mechanism 200 being in a "permitted flow" state. Since the first part 221 is formed by a thin membrane, even if the blood pressure difference between the left atrium and the right atrium changes slightly, the first part 221 can be deformed radially according to the change in pressure. The flow regulation has high sensitivity and strong adaptability. At the same time, it can also timely reduce the degree of blood reflux from the right atrium to the left atrium.

[0074] Specifically, the spacing between the first vertical rod 213 and the second vertical rod 214 of the fixing portion 211 is relatively small, roughly equal to the width of the second portion fixed thereto. Therefore, when subjected to a radial force toward the axis, the second portion 222 cannot significantly sag toward the center. The width of the first portion 221 is significantly greater than the linear distance between the fixing portions 211 on either side (when the adjustment tube 220 is fully extended, it assumes a cylindrical configuration. In this case, the first portion 221 is a portion of the circumference of the cylinder, and the linear distance between the fixing portions on either side is equal to the distance between the two side edges of the circumference). Therefore, it is not constrained by the fixing portions 211 and will sag toward the central axis when subjected to a radial force toward the axis. The first portion 221 forms a blocking portion. When the first portion 221 is in the collapsed configuration, it sags toward the central axis, reducing the flow cross-sectional area of ​​the adjustment tube 220. The adjustment tube 220 is divided into two facing first portions 221 by the two fixing portions 211. When the two first portions 221 are recessed toward the central axis, the portions located near the central axis contact each other, blocking the passage there. Meanwhile, the portions of the first portions 221 located near the fixed portion 211 are pulled away from each other by the first and second vertical rods 213 and 214, forming two sub-channels 230 with roughly triangular cross-sections. The sub-channels 230 prevent the two first portions 221 from completely contacting each other, preventing adhesion due to cardiac tissue hyperplasia. Furthermore, the small cross-sectional area of ​​the sub-channels 230 does not significantly affect the flow rate of fluid flowing back to the inlet 113. In this case, the shunt channel includes the sub-channels 230, and the sum of the cross-sectional areas of the sub-channels 230 constitutes the first flow cross-sectional area of ​​the shunt channel. When pressurized fluid flows from the inlet 113 under the action of a pressure differential, forcing the first portions 221 to open, they arch away from the central axis, resulting in a larger second flow cross-sectional area for the shunt channel.

[0075] The above arrangement enables the blocking portion to function as follows: when the fluid pressure within the diverter 100 is less than the fluid pressure outside the flow regulating mechanism 200, the blocking portion is driven by the fluid pressure outside the flow regulating mechanism 200 to radially concave, thereby placing the flow regulating mechanism 200 in a "flow-restricted" state, i.e., the first state. When the fluid pressure within the diverter 100 is greater than the fluid pressure outside the flow regulating mechanism 200, the blocking portion is driven by the fluid pressure within the diverter 100 to radially open, thereby placing the flow regulating mechanism 200 in a "flow-permitted" state, i.e., the second state. Here, the "outside" of the flow regulating mechanism 200 refers to the interior, which is connected to the inlet of the diverter 100. It will be understood that in the first state, the fluid pressure acts directly on the outer surface of the blocking portion. By providing a shaping frame, the first portion 221 can be deformed in a controlled manner, thereby concaving and bulging in the desired direction, thereby avoiding instability caused by random deformation of the regulating tube. In the initial state, that is, before being implanted into the human body, the blocking portion has a certain degree of freedom and may be in a retracted state or an open state. Therefore, the flow regulating mechanism 200 may be in either the first state or the second state.

[0076] In some optional embodiments, the shunt channel can be formed only by the bracket 110 and the shunt tube 120, and the flow regulating mechanism 200 only serves as a flow regulating valve at the outlet of the shunt member 100, or the flow regulating mechanism 200 is arranged inside the shunt member 100, and the shunt member 100 can also have other structures such as V-shaped or H-shaped. When the flow regulating mechanism 200 is arranged inside the shunt member 100, the blocking portion is configured so that when the fluid pressure at the shunt member inlet (which can also be understood as the fluid pressure inside the shunt member near the inlet) is less than the fluid pressure outside the flow regulating mechanism (which can also be understood as the fluid pressure inside the shunt member near the outlet), the blocking portion is driven by the fluid pressure outside the flow regulating mechanism to radially contract so that the flow regulating mechanism is in the first state. When the fluid pressure at the shunt member inlet is greater than the fluid pressure outside the flow regulating mechanism, the blocking portion is driven by the fluid pressure at the shunt member inlet to radially open so that the flow regulating mechanism is in the second state.

[0077] Preferably, the first vertical rod 213 and the second vertical rod 214 gradually converge from the annular frame to the horizontal rod 215. This design allows the regulating tube 220 to gradually change between the first and second states in response to pressure changes, thereby more rationally regulating the flow rate of the fluid flowing through the shunt channel, achieving low-flow shunt under low pressure and high-flow shunt under high pressure, thereby improving the safety and effectiveness of atrial shunt. Of course, in actual use, the material and related parameters of the tube 220 can also be adjusted to achieve the desired flow control method.

[0078] When the shunt device is implanted in the hole of the atrial septum, the inlet 113 of the shunt 100 is located in the left atrium, and the flow regulating mechanism 200 and the outlet 114 are located in the right atrium. When the pressure in the left atrium is higher than that in the right atrium, the blood flow can enter the shunt 100 under the action of the pressure difference and push the first part 221 radially open to enter the right atrium, thereby realizing the shunt function. When the pressure in the left atrium is lower than that in the right atrium, the blood flow in the right atrium tends to enter the left atrium, so the first part 221 will be collapsed from the outside, thereby forming two sub-channels 230, which restrict the blood flow from further entering the left atrium. In addition, due to the presence of the sub-channels 230, the first part 221 is difficult to adhere together, thus avoiding the formation of neointimal hyperplasia along the edge of the regulating tube from the edge of the fixed part, thereby avoiding permanent blockage of the shunt channel.

[0079] In some alternative embodiments, the dimensions of the first portion 221 can be adjusted to achieve varying degrees of depression, thereby adjusting the degree of fluid restriction and the closed state of the first portion 221 in the first state. Refer to Figures 3 and 4. Figure 3 is a schematic diagram of the flow control mechanism 200 in the second state in an alternative embodiment, and Figure 4 is a schematic diagram of the flow control mechanism 200 in the first state shown in Figure 3. Increasing the spacing between the first vertical rod 213 and the second vertical rod 214 can increase the width W of the second portion 222, thereby increasing the flow cross-sectional area of ​​the subchannel 230 in the first state. Furthermore, the degree of depression achieved by the first portion 221 can be reduced. In extreme cases, the two first portions 221 no longer contact, forming a narrow gap between them. Furthermore, the dimensions of the flexible adjustment tube 220 can be controlled to achieve a preferred closed state, as shown in Figure 2. Specifically, making the axial length of the first portion 221 of the flexible adjustment tube 200 smaller than the axial length of the second portion 222 facilitates the formation of the subchannel 230. The edge profile of the first portion 221 can be a curve with a minimum length dimension h at its center, while the edge profile of the second portion 222 can be a curve connected to the edge profile of the first portion 221 and have a maximum length dimension H at its center. The ratio of h to H can be selected between 0.3 and 1 depending on the situation. Furthermore, the edge profile of the first portion 221 can be a curve that is concave toward the inlet 113, while the edge profile of the second portion 222 can be a curve that smoothly transitions to the edge profile of the first portion 221. The axial dimension of the portion of the first portion 221 away from the fixing portion 211 is smaller than the dimension of the portion closer to the fixing portion 211. In this case, when the ratio of h to H is less than 1 and the maximum length dimension H is greater than the distance D between the two fixing members (or the diameter of the adjustment tube 220), the film can be improved in alignment and wrinkles can be reduced. The ratio of H to D can be selected between 0.5 and 3.

[0080] In other optional embodiments, the number of fixing portions 211 can be three or more, and the adjustable flexible tube 220 can be correspondingly divided into three or more first portions 221 and three or more second portions, forming three or more sub-channels. The first portion 221 acts as a barrier to limit the fluid flow in the diversion channel. In other optional embodiments, the adjustable flexible tube 220 can also be mounted on the outside of the shaping frame 210. In other optional embodiments, the adjustable flexible tube 220 and the diversion flexible tube 120 are separate bodies, and can be formed by applying and / or winding two different films.

[0081] Referring to Figure 5, Figure 5 is a schematic structural diagram of a diverter device according to another embodiment of the present application. In the diverter device of this embodiment, the diverter member 100 is the same as the diverter member described above, and the flow regulating mechanism 200a includes a shaping frame 210a and a regulating flexible cylinder 220a. Other similarities will not be repeated. The difference is that the shaping frame 210a of the flow regulating mechanism 200a is formed by bending a metal wire, rather than cutting a metal tube. The shaping frame 210a is a frame structure formed by bending a metal wire and having two fixing portions 211a. Compared to the shaping frame formed by cutting a metal tube, the shaping frame formed by bending the metal wire has better pressure gripping performance and is easy to assemble and transport. The fixing portion 211a includes a first vertical rod 213a and a second vertical rod 214a, both of which are formed by bending a metal wire into an acute angle. The spacing between the two fixing portions 211a is equal to the diameter of the bracket 110 in the diverter member 100. Preferably, the regulating tube 220a and the shunt tube 120 in the shunt member 100 are coated with the same membrane, which reduces the need for additional implant materials, thereby reducing inflammatory reactions and reducing the risk of stenosis. The regulating tube 220a is divided into a pair of first parts 221a and a pair of second parts 222a by two fixing parts 211a. The width (circumferential dimension) of the first part 221a is large, and it can be radially concave and arched; the width of the second part 222a is small, and it is fixed to the first vertical rod 213a and the second vertical rod 214a and cannot be deformed radially, thereby maintaining a arched state. In some optional embodiments, the regulating tube 220a can also be coated on the outside of the fixing frame 210a. Even if the width of the fixing portion 211a (the distance between the first vertical rod 213a and the second vertical rod 214a) is small, or even if the first vertical rod 213a and the second vertical rod 214a are directly connected at one end without a distinct crossbar, a second portion 222a having a predetermined width can be formed, and the portions of the two first portions 221 near the fixing portion 211 will not intersect. Preferably, similar to the previous embodiment, the axial dimension of the portion of the first portion 221a away from the fixing portion 211a is smaller than the dimension near the fixing portion 211a, so that when the two opposing second portions 222a approach each other, they can form an aligned state as shown in FIG. 2 , reducing wrinkles and further preventing neointimal hyperplasia.

[0082] The inventors have discovered that, as shown in Figures 1 and 10 , when the shaping frame 210, 210a has two fixed portions 211, 211a, if the mobility of one of the first portions 221, 221a is partially restricted (due to tissue hyperplasia, endothelialization, etc.), the flow regulation effect can be significantly affected, and can even seriously affect the therapeutic effect of the shunt device. Based on this, the applicants conducted multiple experiments and verifications and designed the shunt device described in the following embodiments.

[0083] Referring to Figures 11 to 13, Figure 11 is a schematic structural diagram of a diverter device according to another embodiment of the present application. The diverter 100 in the diverter device in this embodiment is similar to the diverter in the aforementioned embodiment, and the similarities will not be repeated here. The difference is that the shaping frame 210a of the flow regulating mechanism 200a is a frame structure having three fixed portions 211a formed by bending a metal wire. In some embodiments, continuing to refer to Figures 11 to 13, the three fixed portions 211a are evenly distributed along the circumference of the regulating hose 220a, which is beneficial to uniform stress on the first portion 221a, and thus helps to extend the service life of the diverter device.

[0084] Referring to Figure 12, compared to the structure of a shaping frame 210a having two fixing portions 211a, the flexible adjustment tube 220a is divided into three first sections 221a and three second sections 222a by three fixing portions 211a. This reduces the force applied to each first section 221a, thereby extending the service life of the flexible adjustment tube 220a. Assuming that the impact force of blood flow during cardiac contraction is F, and that each first section 221a is subjected to uniform force, then: when the shaping frame 210a has two fixing portions 211a, the tension applied to each first section 221a is 1 / 2*F; whereas when the shaping frame 210a has three fixing portions 211a, the tension applied to each first section 221a is 1 / 3*F. In other words, the greater the number of first sections 221a, the less tension each first section 221a experiences, thereby extending its service life.

[0085] In addition, referring to Figures 2 and 12, compared with the shaping frames 210 and 210a having two fixing parts 211 and 211a, when the shaping frame 210a has three fixing parts 211a, when the mobility of any first part 221a is limited (caused by tissue hyperplasia and endothelialization, etc.), since there are still two first parts 221a that can work, the regulating tube 220a can still provide a larger flow cross-sectional area in the second state, ensuring sufficient forward shunt (blood shunting from the left atrium to the right atrium) flow and effectively regulating the flow, and can still provide a smaller flow cross-sectional area in the first state, ensuring that the reverse shunt (blood shunting from the right atrium to the left atrium) effect is effectively reduced. For example, after a single first part 221a fails (loses mobility and is in a retracted state), when the shaping frame 210a has two fixing parts 211a, the maximum forward shunt flow is approximately 1 / 2 of the original shunt flow, and when the shaping frame 210a has three fixing parts 211a, the maximum forward shunt flow is approximately 2 / 3 of the original shunt flow. The original shunt flow here refers to the maximum shunt flow when all the first parts 221a are effective and the flow regulating mechanism is in the second state. Therefore, compared with two fixing parts, three fixing parts can provide better ability to maintain forward shunt and reduce reverse shunt. As far as the atrial shunt device is concerned, due to the smaller overall size, when the adjusting tube 220a includes three first parts 221a, it can not only extend the service life of the shunt device and maintain the effective function of the shunt device, but also avoid excessive complexity of the processing technology.

[0086] Referring to Figures 11, 12 and 13, the forming frame 210a of the flow regulating mechanism 200a in Figure 13 has three fixing portions 211a. In some embodiments, the bracket 110 and the forming frame 210a of the diverter 100 are metal frames formed by winding a wire. The integrally formed metal frame has multiple continuous "W" wave structures, which extend in a spiral shape as a whole. The forming frame 210a of the regulating hose at the outlet of the flow regulating mechanism can be more flexibly set by the "W" wave structure, thereby adjusting the closing shape of the blocking portion, and then adjusting the blocking portion to reduce the effect of reverse diversion. For example, the fixing portion of the forming frame 210a is formed by a part of the "W" wave structure. Compared with the frame formed by cutting, the metal frame formed by winding a wire has smooth edges. After being combined with the coating, it can effectively avoid damage to the regulating hose by the sharp structure, and can extend the service life of the diverter.

[0087] The metal frame, constructed from a single piece of wire, is easily foldable and easily compressed and gripped, allowing it to be compressed into shapes not possible with the splitter and shaping frame as separate components, such as a C-shape. The resulting compression also reduces the overall diameter, facilitating minimally invasive surgery. Furthermore, once the metal frame is laminated to form the flexible tubes (the splitter and regulating tubes), the inner lumen of the tubes is smoother, avoiding the step at the junction of the splitter and shaping frame, which occurs when the splitter and shaping frame are separate. This improves the long-term patency of the hoses, thereby increasing the lifespan of the splitter device.

[0088] When a detection module such as a pressure measuring module is set up at the same time, a metal frame made of wire wound integrally can effectively reduce or avoid the appearance of a closed loop structure on any cross section, reducing or avoiding interference and blocking of the pressure measuring module signal transmission.

[0089] Preferably, the elastic wire used to make the metal frame is nickel-titanium wire, which has good biocompatibility and suitable strength and flexibility.

[0090] As shown in Figures 11 and 13, in some embodiments, the support 110 of the diverter 100 includes a clamping device comprising multiple pairs of first and second clamping arms 111a, 112a, and a diverter portion. The first and second clamping arms 111a, 112a extend from the diverter portion of the support 110 and gradually approach each other, with the diverter portion being in contact with the diverter hose. Furthermore, the first and second clamping arms 111a, 112a are integrally wound and formed with the diverter portion of the support 110. Thus, the first and second clamping arms 111a, 112a can swing relative to the diverter portion along the axial direction of the diverter 100, making the connection less susceptible to breakage. This not only improves the clamping force of the clamping device but also allows the spacing between the first and second clamping arms 111a, 112a to be adaptively adjusted to accommodate tissues of varying thicknesses. Preferably, each first clamping arm 111a and / or each second clamping arm 112a is composed of two extended wire segments and one annular wire segment, and both ends of the annular wire segment are respectively connected to an extended wire segment, thereby further improving the clamping force of the clamping device.

[0091] In other optional embodiments, the shaping frame can also be integrally formed with the adjustable tube. For example, a reinforcing structure equivalent to the fixing portion 211a is provided in the tube wall of the adjustable tube. Such a reinforcing structure can also be formed from a portion of the tube wall of the adjustable tube (for example, by thermoplastic technology), as long as the relevant structural parts can be ultimately formed.

[0092] Referring to Figures 6a and 6b, Figure 6a is a schematic structural diagram of a shunt device according to another embodiment of the present application, and Figure 6b is a cross-sectional view BB in Figure 6a. The flow regulating mechanism is in the first state. The shunt device in this embodiment, the shunt member 100 is the same as the aforementioned shunt member. The difference is that the shaping frame 210f of the flow regulating mechanism 200f is formed by elastic wire, and the shaping frame and the regulating tube 220f are pre-shaped to form an initial state, which is the first state. The regulating tube 220f has a smaller first flow cross-sectional area. Figure 7 is a schematic structural diagram of the flow regulating mechanism of the shunt device shown in Figure 6a in the second state. At this time, the pressure in the left atrium is higher than that in the right atrium. Under the action of the pressure difference, blood can enter the shunt member 100 and push the regulating tube 220f radially into the right atrium, realizing the shunt function. When the left atrial pressure is lower than the right atrial pressure, the blood flow in the right atrium tends to enter the left atrium, so pressure is applied to the regulating tube 220f from the outside. At the same time, under the action of the preset shape, the regulating tube 220f returns to the preset shape, thereby limiting the blood flow from further entering the left atrium.

[0093] The shaping frame in the present embodiment includes a plurality of elastic threads, which are connected and shaped into an initial state through a predetermined shaping process. In this initial state, one end of the elastic thread is connected and the orthographic projection of the end can be connected to form a circle with a predetermined diameter, which matches the diameter of the adjustment tube, and the other end of the elastic thread is also connected, thereby forming at least two elastic guide frames 211f, and the elastic guide frames 211f extend axially and gradually approach the central axis to form an elastic cantilever tilted to the central axis. Preferably, these elastic threads are integrally formed, that is, formed by a single thread. The shaping frame is fixed to the adjustment tube through processes such as sewing or hot pressing. Under the constraint of the elastic guide frames 211f, the first portion 221f of the adjustment tube is configured to be able to be radially recessed and arched, becoming a blocking portion, while the second portion 222f is not constrained by the elastic guide frames 211f and remains in a arched state.

[0094] In the initial state, the flow regulating mechanism is in the first state, i.e., the "restricted flow" state. In this embodiment, the shaping frame 210f includes six elastic guide frames 211f, thereby dividing the regulating tube 220f into 12 sections: six first sections 221f and six second sections 222f. In the first state, the regulating tube 220f forms a petal-shaped structure. The elastic guide frames 211f include a first vertical rod 213f and a second vertical rod 214f. The first section 221f is located between the first and second vertical rods 213f, 214f. The second section 222f is located between two adjacent elastic guide frames 211f. As shown in Figure 7, when blood flows out of the flow regulating mechanism 200f through the diversion channel at the inlet of the diversion element 100, the blood pushes the shaping frame to expand radially outward. The regulating tube gradually arches due to the pressure difference between the two sides until it returns to its cylindrical shape. The diversion channel has a second flow cross-sectional area, and the flow regulating mechanism 200f is in the second state, i.e., the "allowed flow" state.

[0095] It is understood that in other embodiments, the second portion 222f of the regulating tube 220f may be partially removed, that is, the regulating tube may only have the first portion 221f forming the blocking portion, and the first portion 221f may swing in the radial direction to realize the conversion of the flow regulating mechanism 200f between the first state and the second state. When the fluid pressure inside the diverter 100 is less than the fluid pressure outside the flow regulating mechanism 200f, the first portion 221f is driven by the pressure fluid outside the flow regulating mechanism 200f to radially contract so that the flow regulating mechanism 200f is in the first state. When the fluid pressure inside the diverter 100 is greater than the fluid pressure outside the flow regulating mechanism 200f, the first portion 221f is driven by the pressure fluid inside the diverter 100 to radially open so that the flow regulating mechanism 200f is in the second state. Specifically, when the first portion 221f is in its initial state, i.e., its collapsed state, the flow regulating mechanism 200f is in its first state. When the first portion 221f is subjected to a radially outward force and moves away from the central axis, the first portion 221f is in its open state, and the flow regulating mechanism 200f is in its second state. In this case, the first flow cross-sectional area of ​​the diversion channel can be adjusted by adjusting the adjacent elastic guide frame.

[0096] In other embodiments, elastic sheets can be used instead of elastic wires, and the elastic guide frame can also be sheet-shaped or a separate elastic wire, fixed to an annular frame. The blocking part can also be made of other materials, not limited to soft and deformable materials, as long as it can extend axially and gradually approach the central axis in the initial state, and move away from the central axis when subjected to radial outward force.

[0097] 8a to 8d , schematic diagrams of flow regulating mechanisms in various optional manners are shown.

[0098] Figure 8a is a schematic diagram of the flow control mechanism in an alternative embodiment. In this embodiment, the shaping frame includes three circumferentially evenly spaced elastic guide frames 211b. The regulating tube has a circular initial end connected to the diverter. The distal end is pressed downward toward the central axis by the three elastic guide frames 211b, forming a Y-shape. In other words, the initial state of the flow control mechanism is the first state, i.e., the "restricted flow" state. The three second portions 222b at the distal end of the regulating tube remain intact, while the first portion 221b between two adjacent second portions 222b is compressed by the elastic guide frames 211b. Each elastic guide frame 211b is formed from two elastic wires. One end of the elastic wire is fixed to the circumferential surface of the diverter, while the other end extends axially and gradually approaches the central axis, forming an elastic cantilever inclined toward the central axis. When subjected to radially outward force, the elastic guide frames 211b can be aligned parallel to the central axis. The three elastic guide frames 211b cause portions of the regulating tube to converge toward the center of the diverter channel, forming a Y-shaped outlet. When pressurized fluid from the diverter passes through the Y-shaped flow cross-section, the pressurized fluid drives the first portion 221b and the elastic guide frame 211b to expand outward, thereby increasing the flow cross-sectional area. After the pressurized fluid in that direction disappears, the elastic guide frame 211b drives the first portion 221b back to its original position, restoring the flow control mechanism to its first state and restricting the reverse flow of pressurized fluid.

[0099] Figure 8b is a schematic diagram of the flow control mechanism in another alternative embodiment. This embodiment is similar to the structure shown in Figure 8a, except that there are four elastic guides 211c, four first sections 221c, and four second sections 222c. In the first state, the flow cross-section formed by the distal end of the regulating tube is X-shaped.

[0100] Figure 8c is a schematic diagram of the flow control mechanism in another alternative embodiment. In this embodiment, the width of the second portion 222e is substantially equal to the width of the first portion 221e. There are two elastic guides 211e, with a large distance between their ends. This creates a larger distance between the two first portions 221e, minimizing the restrictive effect on the pressurized fluid.

[0101] Figure 8d is a schematic structural diagram of a flow regulating mechanism in another optional embodiment. In this embodiment, the number of elastic guide frames 211d is four. The four elastic guide frames 211d are divided into two pairs of clamping structures. The two pairs of clamping structures are evenly distributed in the circumferential direction. The two elastic guide frames 211d in the clamping structure are relatively close to each other, and a part of the regulating tube between the two is completely retracted together, which is the first part 221d. The second part 222d located between the two pairs of clamping structures forms a diversion channel with a smaller diameter, and the regulating tube can expand under the push of the pressure fluid from the diversion tube (while pushing the elastic guide frame 211d), thereby opening the first part 221d.

[0102] In other embodiments, suitable materials can also be selected to form the blocking portion through pre-forming (that is, the forming frame and the blocking portion are formed as one piece), so that it can be converted between a folded state and an open state, as long as the first flow cross-sectional area corresponding to the folded form of the blocking portion is smaller than the second flow cross-sectional area corresponding to the open form, and the first flow cross-sectional area is greater than zero (the flow regulating mechanism is not completely closed).

[0103] It is understood that in the above embodiments, at a certain moment, when the fluid pressure at the inlet and / or inside the diverter is equal to the fluid pressure outside the flow regulating mechanism, the blocking portion will remain in the state it was in under the pressure gradient at the previous moment. For example, when the fluid pressure inside the diverter is greater than the fluid pressure outside the flow regulating mechanism at the previous moment, the blocking portion is driven by the fluid pressure inside the diverter to open radially to place the flow regulating mechanism in the second state. At the next moment, if the fluid pressure inside the diverter is equal to the fluid pressure outside the flow regulating mechanism, the blocking portion will remain in the second state.

[0104] Refer to Figure 9, which is a structural diagram of a shunt device according to another embodiment of the present application. In this embodiment, the shunt device includes a shunt 10 and a sensor 20. The shunt 10 is the shunt device in the aforementioned embodiment. The monitoring device is used to monitor human physiological parameters such as pressure, blood viscosity and flow rate. The monitoring device can be, for example, a wireless pressure sensor that can monitor the pressure in the heart or blood vessels. The detection device is fixed side by side and tangentially to the periphery of the shunt part of the shunt 10. The shunt 10 and the sensor 20 can be connected together by means of sleeve crimping, bonding, suturing and welding, so that after being implanted in the human body, they can simultaneously realize the treatment and diagnosis functions.

[0105] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in this application should be included in the scope of protection of this application. Therefore, the scope of protection of this application should be based on the scope of protection of the claims.

Claims

1. A flow diversion device for diverting a pressure fluid, characterized in that: include: A flow divider, comprising a main body and an inlet and an outlet located at two ends of the main body, the flow divider defining a flow divider channel for the pressure fluid; as well as A flow regulating mechanism connected to the flow dividing member, the flow regulating mechanism being used to regulate the flow of the pressure fluid flowing through the flow dividing channel; The flow regulating mechanism comprises a barrier portion with a changeable shape, and the barrier portion is configured to be driven by the fluid pressure outside the flow regulating mechanism to contract radially when the fluid pressure at the inlet of the diverter is lower than the fluid pressure outside the flow regulating mechanism.

2. The flow dividing device according to claim 1, characterized in that: The blocking portion is configured to be driven by the fluid pressure outside the flow regulating mechanism to contract radially when the fluid pressure inside the diverter is lower than the fluid pressure outside the flow regulating mechanism, so that the flow regulating mechanism will never completely close the diverter channel.

3. The flow dividing device according to claim 1 or 2, characterized in that: The blocking portion is used to change the flow cross-sectional area of ​​the shunt channel, and the flow regulating mechanism has a first state and a second state. In the first state, the blocking portion is in a retracted state so that the shunt channel has a first flow cross-sectional area. In the second state, the blocking portion is in an open state so that the shunt channel has a second flow cross-sectional area. The first flow cross-sectional area is greater than zero and less than the second flow cross-sectional area. The blocking portion is configured to be driven by the fluid pressure outside the flow regulating mechanism to radially contract to place the flow regulating mechanism in the first state when the fluid pressure at the inlet and / or inside the diverter is lower than the fluid pressure outside the flow regulating mechanism.

4. The flow dividing device according to claim 3, characterized in that: When the blocking portion is in a retracted form, the blocking portion is deformed into a recessed state, and when the blocking portion is in an open form, the blocking portion is deformed into a bowed state; the blocking portion is configured to be driven by the fluid pressure outside the flow regulating mechanism to radially recess to place the flow regulating mechanism in the first state when the fluid pressure at the inlet and / or inside the diverter is less than the fluid pressure outside the flow regulating mechanism.

5. The flow dividing device according to any one of claims 1 to 4, characterized in that: The flow regulating mechanism comprises a regulating soft cylinder connected to the diverter, the cylinder wall of the regulating soft cylinder comprises a first part distributed in the circumferential direction, the first part is configured to be recessed or arched in the radial direction, and the first part is the blocking part.

6. The flow dividing device according to claim 5, characterized in that: The regulating tube also includes a second part, which is distributed circumferentially apart from the first part; the flow regulating mechanism also includes a shaping frame, which supports a predetermined position of the regulating tube so that the second part maintains the arched state and the first part can be controllably concave or arched under the restriction of the shaping frame.

7. The flow dividing device according to claim 6, characterized in that: The shaping frame comprises a plurality of fixing parts, one end of which is connected to the diverter and the other end of which extends axially, and the plurality of fixing parts are distributed in the circumferential direction of the regulating flexible cylinder; The tube wall of the regulating soft tube includes a plurality of first parts and a plurality of second parts corresponding to the plurality of fixing parts, wherein the first part is arranged between two circumferentially adjacent fixing parts, and the second part is fixed to the fixing parts and has a predetermined width so that parts of two adjacent first parts close to the fixing parts cannot contact each other.

8. The flow dividing device according to claim 7, characterized in that: The width of the fixing portion is consistent with the width of the second portion, and the adjusting soft cylinder is arranged on the inner side and / or the outer side of the fixing portion.

9. The flow dividing device according to claim 7 or 8, characterized in that: The fixing portion includes a first vertical rod and a second vertical rod connected to each other, with a predetermined distance between the first vertical rod and the second vertical rod, one end of the first vertical rod and one end of the second vertical rod are connected to the diverter, and the other end of the first vertical rod and the other end of the second vertical rod gradually approach each other along their respective extension directions.

10. The flow dividing device according to claim 9, characterized in that: The fixing portion further includes a cross bar connecting the other end of the first vertical bar and the other end of the second vertical bar, a reinforcing rib arranged between the first vertical bar and the second vertical bar, and an annular frame connecting the one end of the first vertical bar and the one end of the second vertical bar.

11. The flow dividing device according to any one of claims 7 to 10, characterized in that: The plurality of fixing portions include three fixing portions.

12. The flow dividing device according to claim 11, characterized in that: The three fixing parts are evenly distributed in the circumferential direction of the adjusting soft cylinder.

13. The flow dividing device according to any one of claims 7 to 12, characterized in that: A hanging ear is arranged at the end of the fixing portion, and the hanging ear is used to be connected to a predetermined structure in the interventional catheter.

14. The flow dividing device according to any one of claims 7 to 13, characterized in that: The edge profile of the first portion is a curve recessed toward the inlet, the edge profile of the second portion is a curve smoothly connected to the edge profile of the first portion, and the axial size of the first portion away from the fixing portion is smaller than that of the portion close to the fixing portion.

15. The flow dividing device according to any one of claims 6 to 14, characterized in that: The edge profile of the first portion is a curve and has a minimum length dimension in the middle position, the edge profile of the second portion is a curve connected to the edge profile of the first portion and has a maximum length dimension in the middle position, and the ratio of the minimum length dimension to the maximum length dimension ranges from 0.3 to 1.

16. The flow dividing device according to claim 15, characterized in that: The ratio of the minimum length dimension to the diameter of the adjusting flexible tube ranges from 0.5 to 3.

17. The flow dividing device according to any one of claims 6 to 16, characterized in that: There are multiple first parts, and when the multiple first parts are recessed, they do not completely contact at the center of the diverting channel, but divide the diverting channel into multiple sub-channels, and the multiple sub-channels are located at the edges of the diverting channel.

18. The flow dividing device according to any one of claims 6 to 16, characterized in that: The number of the first parts is plural, and the plurality of first parts do not contact each other and form a slit when they are recessed.

19. The flow dividing device according to any one of claims 6 to 18, characterized in that: The flow divider and the shaping frame are metal frames formed by integrally winding wires, and any cross section of the metal frame is a non-closed profile.

20. The flow dividing device according to any one of claims 6 to 18, characterized in that: The shaping frame is integrally formed with the blocking portion or connected to the blocking portion as a separate part, and the separate part is formed by cutting a metal tube or bending a metal wire.

21. The flow dividing device according to any one of claims 5 to 20, characterized in that: The main body includes a bracket and a diverter tube arranged on the inner surface and / or outer surface of the bracket, the diverter tube and the regulating tube are integrally formed, the diverter piece is connected to the flow regulating mechanism at the outlet, the main body and the diverter tube form the first section of the diverter channel, and the regulating tube forms the second section of the diverter channel.

22. The flow dividing device according to claim 21, characterized in that The bracket includes a clamping device and a diverter portion. The clamping device includes a plurality of pairs of first clamping arms and second clamping arms. The first clamping arms and the second clamping arms are respectively extended from the diverter portion.

23. The flow dividing device according to claim 22, characterized in that: The first clamping arm and the second clamping arm are respectively extended from the diversion part of the bracket and gradually approach each other.

24. The flow dividing device according to claim 23, characterized in that Each of the first clamping arms and / or each of the second clamping arms is composed of two extended wire segments and one annular wire segment, and two ends of the annular wire segment are respectively connected to one of the extended wire segments.

25. The flow dividing device according to claim 4, characterized in that: The flow regulating mechanism further comprises a shaping frame, wherein the shaping frame comprises a plurality of elastic guide frames, and the elastic guide frames are connected to the blocking portion and enable the blocking portion to maintain a retracted shape in an initial state.

26. The flow dividing device according to claim 25, characterized in that One end of the elastic guide frame is connected to the main body, and the other end forms an elastic cantilever in the axial direction, and the other end is closer to the center of the diversion channel than the one end.

27. The flow dividing device according to claim 26, characterized in that The flow regulating mechanism includes an regulating soft cylinder connected to the diverter, the cylinder wall of the regulating soft cylinder includes a first part and a second part distributed in the circumferential direction, the second part and the first part are distributed in the circumferential direction and are separated from each other; the first part is configured to be able to be recessed or arched in the radial direction, the first part is the blocking part, and the elastic guide frame enables the second part to always maintain a arched state.

28. The flow dividing device according to any one of claims 25 to 27, characterized in that: The elastic guide frame is formed by bending a metal wire and can reach a state parallel to the central axis of the diverter when subjected to a radial outward force.

29. The flow dividing device according to any one of claims 4 to 28, characterized in that: The number of the blocking parts is plural, and the initial state of the flow regulating mechanism is the first state or the second state.

30. The flow dividing device according to any one of claims 1 to 29, characterized in that: The flow dividing device further comprises a monitoring device, and the monitoring device is connected in parallel with the flow dividing member.

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