Flow dividing device

Abstract

The invention provides a flow dividing device which is used for dividing pressure fluid and comprises a flow dividing piece and a flow adjusting mechanism. The flow dividing piece comprises a body, an inlet and an outlet, wherein the inlet and the outlet are located at the two ends of the body. The flow adjusting mechanism is connected with the flow dividing piece and used for adjusting the flow of the pressure fluid flowing through the flow dividing channel. The flow adjusting mechanism comprises an adjusting soft barrel communicated with the flow dividing piece, the barrel wall of the adjusting soft barrel comprises a first part distributed in the circumferential direction, the first part is a blocking part with the variable shape and is used for changing the circulation sectional area of the flow dividing channel, and the flow adjusting mechanism cannot completely close the flow dividing channel all the time.

Description

Technical Field

[0001] The present disclosure relates to the technical 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 are dyspnea, fatigue and fluid retention (pulmonary congestion, systemic congestion and peripheral edema). Heart failure can be divided into three categories, namely 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 means of improving left atrial hypertension. It guides the blood flow from the left atrium to the right atrium by making a hole in the atrial septum, thereby reducing the load on the left atrium. The atrial shunt can establish a pathway between the left atrium and the right atrium by limiting the diameter of the atrial septal stoma, effectively reducing the patient's left atrial pressure, relieving pulmonary congestion and dyspnea. After the atrial shunt is implanted, when the left atrial pressure is higher than the right atrial pressure, blood will not flow back from the right atrium to the left atrium. When the patient's right atrial pressure is higher than the left atrium during certain time periods (such as holding breath, Valsalva maneuver), or when the pressures of the two atria are close, it will cause undesirable reflux, forming a shunt 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 will increase the risk of migraine or paradoxical embolism, as well as increase left atrial filling and reduce blood oxygen content.

[0004] Therefore, in the existing atrial shunt design, some people have proposed that a one-way valve structure can be added inside the shunt, which is opened only when the pressure in the left atrium is higher than that in the right atrium to allow blood to flow from the left atrium to the right atrium, and completely closed when the pressure in the left atrium is lower than that in the right atrium to prevent blood from flowing back from the right atrium to the left atrium. However, the inventors have found that this design will bring new problems in actual use. The one-way valve structure is prone to failure after a period of time in the body and can no longer open in response to the pressure difference, thereby causing the shunt to fail. Summary of the invention

[0005] In view of this, the present disclosure provides a flow dividing device for solving one or more problems in the prior art.

[0006] In a first aspect, a flow diversion device is provided for diverting a pressure fluid, which includes a flow diversion member and a flow regulating mechanism. The flow diversion member includes a main body and an inlet and an outlet located at both ends of the main body, and the flow diversion member defines a flow diversion channel for the pressure fluid; the flow regulating mechanism is connected to the flow diversion member, and the flow regulating mechanism is used to regulate the flow of the pressure fluid flowing through the flow diversion channel; the flow regulating mechanism includes an adjusting soft cylinder connected to the flow diversion member, and the cylinder wall of the adjusting soft cylinder includes a first part distributed in the circumferential direction, and the first part is a morphologically variable blocking part, which is used to change the flow cross-sectional area of ​​the diversion channel, and the flow regulating mechanism will never completely close the diversion channel.

[0007] In one possible implementation, 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 diversion channel has a first flow cross-sectional area. In the second state, the blocking portion is in an open state so that the diversion 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.

[0008] In combination with the above possible implementations, in another possible implementation, 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 put the flow regulating mechanism in a retracted state when the fluid pressure at the inlet and / or inside the diverter is less than the fluid pressure outside the flow regulating mechanism.

[0009] In combination with the above possible implementations, in another possible implementation, the regulating tube also includes a second part, which is circumferentially distributed and spaced apart from the first part; the flow regulating mechanism also includes a shaping frame, which supports a predetermined portion 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.

[0010] In combination with the above possible implementations, in another possible implementation, the shaping frame supports a predetermined portion of the adjusting soft tube so that the second part maintains the arched state, 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 tube; the tube wall of the adjusting soft tube 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.

[0011] In combination with the above possible implementation methods, in another possible implementation method, the width of the fixed part is consistent with the width of the second part, the adjusting soft tube is arranged on the inner side and / or the outer side of the fixed part, the width of the first part is greater than the straight-line distance between the two fixed parts on both sides of the first part, and when the first part is in a retracted form, a slit is formed between the first parts; the distance between the two fixed parts is equal to the diameter of the adjusting soft tube.

[0012] 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, a predetermined distance is provided between the first vertical rod and the second vertical rod, the second portion is located 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.

[0013] In combination with the above possible implementations, in another possible implementation, the fixing portion further includes a cross bar 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.

[0014] In combination with the above possible implementations, in another possible implementation, the edge profile of the first part is a curve and has a minimum length dimension in 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 in the middle position, the ratio of the minimum length dimension to the maximum length dimension ranges from 0.3 to 1, and / or the ratio of the minimum length dimension to the diameter of the adjustment tube ranges from 0.5 to 3.

[0015] In combination with the above possible implementations, in another possible implementation, the edge profile of the first part is a curve that is recessed 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 a portion of the first part away from the fixed portion is smaller than the size of a portion close to the fixed portion.

[0016] In combination with the above possible implementations, in another possible implementation, there are multiple first parts, and when recessed, the multiple first parts do not completely contact at 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.

[0017] In combination with the above possible implementations, in another possible implementation, the flow regulating mechanism further includes a shaping frame, the shaping frame includes a plurality of elastic guide frames, the elastic guide frames are connected to the blocking portion and enable the blocking portion to remain in a retracted shape in an initial state.

[0018] 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 one end; in the initial state, part of the structure of the adjusting soft tube gathers toward the center of the diversion channel and forms a petal-shaped structure or a Y-shaped or X-shaped outlet, or part of the adjusting soft tube is completely retracted together.

[0019] In combination with the above possible implementations, in another possible implementation, the wall of the adjusting soft cylinder also includes a second part distributed in the circumferential direction, and 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, and the elastic guide frame enables the second part to always maintain a arched state.

[0020] In combination with the above possible implementations, in another possible implementation, 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; there are multiple elastic guide frames, and each of the elastic guide frames includes a first vertical rod and a second vertical rod, the first part is located between the first vertical rod and the second vertical rod, and the second part is located between two adjacent elastic guide frames.

[0021] 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 formed by cutting a metal tube or bending a metal wire.

[0022] 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 retracted state or the open state.

[0023] In combination with the above possible implementations, in another possible implementation, the main body includes a bracket and a diverter tube, the diverter tube is formed by a coating applied on the inner surface and / or outer surface of the bracket, the diverter tube and the regulating tube are integrally formed, the bracket is connected to the flow regulating mechanism at the outlet, the bracket and the diverter tube form the first section of the diverter channel, and the regulating tube forms the second section of the diverter channel.

[0024] In combination with the above possible implementations, in another possible implementation, the diverter device further includes a monitoring device, and the monitoring device is connected in parallel with the diverter.

[0025] In combination with the above possible implementation manner, in another possible implementation manner, the flow regulating mechanism is disposed inside the diverter.

[0026] The shunt device provided by the present invention is different from the one-way valve structure in the prior art which is designed to be completely closed when preventing backflow. The flow regulating mechanism of the present invention will never completely close the flow channel. While taking into account that tiny backflow will not affect the normal physiological functions of the human body, the incomplete closing design effectively avoids the failure problem caused by neointimal hyperplasia, ensures the shunt function that the shunt should have, 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

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings required for use in the embodiments are briefly introduced below.

[0028] It should be understood that the following drawings only illustrate certain embodiments of the present disclosure and should not be viewed as limiting the scope.

[0029] It should also be understood that the same or similar reference numerals are used in the drawings to represent the same or similar elements.

[0030] 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.

[0031] Figure 1 It is a structural schematic diagram of a diversion device according to an embodiment of the present disclosure.

[0032] Figure 2 yes Figure 1 Schematic diagram of the end face structure on the outlet side of the flow regulating mechanism.

[0033] Figure 3 The diagram is a schematic diagram of a second state of a flow regulating mechanism in an optional implementation manner.

[0034] Figure 4 yes Figure 3 Schematic diagram of the flow regulating mechanism in the first state.

[0035] Figure 5 It is a structural schematic diagram of a diversion device according to another embodiment of the present disclosure, wherein the flow regulating mechanism is in a first state.

[0036] Figure 6a It is a structural schematic diagram of a flow diversion device according to another embodiment of the present disclosure, wherein the flow regulating mechanism is in a first state.

[0037] Figure 6b yes Figure 6a BB cross-sectional view in.

[0038] Figure 7 yes Figure 6a The flow regulating mechanism of the diverter device shown is a structural schematic diagram in the second state.

[0039] Figure 8a It is a schematic diagram of the structure of the flow regulating mechanism in an optional implementation manner.

[0040] Figure 8b It is a structural schematic diagram of a flow regulating mechanism in another optional implementation manner.

[0041] Figure 8c It is a structural schematic diagram of a flow regulating mechanism in another optional implementation manner.

[0042] Figure 8d It is a structural schematic diagram of a flow regulating mechanism in another optional implementation manner.

[0043] Fig. 9 It is a structural schematic diagram of a diversion device according to another embodiment of the present disclosure.

[0044] Description of reference numerals:

[0045] 10-shunt, 20-sensor;

[0046] 100 - flow dividing member, 110 - bracket, 111 - first clamping arm, 112 - second clamping arm, 113 - inlet, 114 - outlet, 120 - flow dividing soft cylinder;

[0047] 200, 200a-flow regulating mechanism, 210, 210a, 210f-shaping frame, 211, 211a-fixing part, 213, 213a, 213f-first vertical rod, 214, 214a, 214f-second vertical rod, 215-cross bar, 216-hanging ear, 217-reinforcing rib, 220, 220a, 220f-adjusting soft cylinder, 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

[0048] The following is an exemplary description of the embodiments of the present disclosure in conjunction with the accompanying drawings. It should be understood that the present disclosure can be implemented in a variety of ways and should not be construed as being limited to the embodiments described here. The embodiments described here are only for a more thorough and complete understanding of the present disclosure.

[0049] It should be understood that the term "including" and its variations used in the present disclosure are open inclusions, that is, "including but not limited to." The term "based on" means "at least in part based on", and the term "plurality" means "two or more".

[0050] It should be understood that although the terms “first” or “second” etc. are used in the present disclosure to describe various elements, these elements are not limited by these terms, and these terms are only used to distinguish one element from another.

[0051] The embodiment of the present disclosure provides a shunt device for shunting 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 pressure fluid. The flow regulating mechanism is arranged on the shunt channel defined by the shunt piece, and is used to regulate the flow rate 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 rate of the fluid flowing from the outlet to the inlet.

[0052] Furthermore, the flow regulating mechanism includes a barrier portion with a variable shape, and the barrier portion is used to change the flow cross-sectional area of ​​the shunt channel by changing its shape. The "flow cross-sectional area" here refers to the cross-sectional area of ​​the narrowest part of the shunt channel, such as the area of ​​the opening formed by the end edge contour of the flow regulating mechanism. Among them, the flow regulating mechanism has a first state and a second state, and can be switched between the first state and the second state under the action of the 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 first state, the barrier portion is in a retracted state so that the shunt channel has a first flow cross-sectional area. In the second state, the barrier portion is in an open state so that the shunt channel has a second flow cross-sectional area, and 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 inlet and / or inside the diverter is less than the fluid pressure outside the flow regulating mechanism, it 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 inlet and / or inside the diverter is greater than the fluid pressure outside the flow regulating mechanism, it is driven by the fluid pressure at the inlet and / or inside the diverter to radially open so that the flow regulating mechanism is in the second state. In the first state, the blocking portion is in a contracted shape and blocks part of the diverter channel, so that only a small amount of fluid can flow from the outlet to the inlet. Since the blocking portion will not be completely closed, the problem of the blocking portion being adhered and unable to open to the second state due to tissue hyperplasia is effectively avoided. In different embodiments, the initial state of the flow regulating mechanism can be either the first state or the second state.

[0053] refer to Figure 1 and Figure 2 . Figure 1 It is a structural schematic diagram of a diversion device according to an embodiment of the present disclosure. Figure 2 yes Figure 1 Schematic diagram of the end face structure on the outlet side of the middle diversion device.

[0054] 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 bracket 110 and a shunt tube 120. The bracket 110 is a cylindrical grid formed by winding, weaving or cutting a metal tube with elastic metal wire, and a plurality of pairs of clamping devices consisting of a first clamping arm 111 and a second clamping arm 112 are arranged on the periphery, and the clamping devices are used to clamp the atrial septum. The shunt tube 120 is formed by a coating applied to the inner surface and / or outer surface of the bracket 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 its approximate position is shown in the figure). The flow regulating mechanism 200 also has an inlet and an outlet, and 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 the shunt 100 is installed on the atrial septum of the heart, the inlet 113 is located in the left atrium, and the outlet 114 and the flow regulating mechanism 200 are located in the right atrium. When the pressure in the left atrium is greater than the pressure in the right atrium, part of the blood flow can pass through the shunt 100 to the right atrium. The flow regulating mechanism 200 can prevent the blood in the right atrium from entering the left atrium when the pressure in the right atrium is greater than that in the left atrium.

[0055] In this embodiment, the flow divider 100 defines a flow divider channel for the pressure fluid, and the bracket 110 and the flow divider soft cylinder 120 form the first section of the flow divider channel. The flow regulating mechanism 200 includes a shaping frame 210 and an adjusting soft cylinder 220. The shaping frame 210 and the adjusting soft cylinder 220 are combined to form the second section of the flow divider channel, and the second section is a channel with a variable flow cross-sectional area, which is connected in series at the outlet 114 of the flow divider 100 and communicates with the first section, so that the flow regulating mechanism 200 can limit the fluid flowing through the outlet 114.

[0056] The shaping frame 210 includes an annular frame and two fixing parts 211. One end of the annular frame is used to connect the diverter 100, and the other end is connected to the two fixing parts 211 in radial symmetry. The fixing part 211 extends parallel to the axis of the annular frame. The fixing part 211 is roughly n-shaped, including 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 are 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, which can improve the structural stability of the shaping frame 210 to prevent the shape of the shaping frame 210 from being damaged and unable to be fully restored when it is pressed and gripped to the conveyor. The two fixing parts 211 face each other, and the spacing between them is equal to the diameter D of the annular frame and the adjusting soft cylinder 220.

[0057] Preferably, if Figure 1As shown, the top ends of the two fixing parts 211 are also provided with hanging ears 216. The hanging ears 216 are used to connect the shunt device to the corresponding structure in the interventional catheter so as to release the shunt device to the target site in a controlled manner. The shaping frame 210 can be formed by cutting a metal cylinder made of elastic material, so when observing from the end face of the flow regulating mechanism 200, the shaping frame 210 is annular as a whole. The positive projection of the end face of the annular frame can be a complete annular structure or a part of a complete annular structure, such as Figure 1 As shown, the annular frame includes two parts on a complete annular structure, two ends of one part are respectively connected to the first vertical rod 213, and two ends of the other part are respectively connected to the second vertical rod 214.

[0058] Preferably, the regulating flexible cylinder 220 is a cylindrical structure formed by a coating. In this embodiment, the regulating flexible cylinder 220 and the diverter flexible cylinder 120 are cylindrical structures formed by the same coating. In some optional embodiments, the diverter flexible cylinder 120 and the regulating flexible cylinder 220 can be two independent flexible cylinders connected together, such as in Figure 1 The middle dotted line is sutured / bonded together. The adjusting soft tube 220 is arranged on the inner surface and / or the outer surface of the shaping frame 210, and the part thereof in contact with the shaping frame 210 is connected to the shaping frame 210.

[0059] The regulating soft cylinder 220 includes a first part 221 and a second part 222. The first part 221 is located between the two fixing parts 211, and the second part 222 is located between the first vertical rod 213 and the second vertical rod 214. The second part 222 is fixed to the fixing part 211 and has a predetermined width W, so that the connection between the second part 222 and the first vertical rod 213 and the connection between the second part 222 and the second vertical rod 214 will not intersect, and the parts of the two first parts 221 close to the fixing part 211 will 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.

[0060] Specifically, the distance between the first vertical rod 213 and the second vertical rod 214 of the fixing part 211 is small, and the distance is roughly equal to the width of the second part fixed thereon, so the second part 222 cannot be significantly concave toward the center when subjected to the radial force toward the axis, and the width of the first part 221 is significantly greater than the straight-line distance between the fixing parts 211 on both sides thereof (when the adjustment tube 220 is fully unfolded, it is in a cylindrical shape, at this time, the first part 221 is a part of the circumference of the cylinder, and the straight-line distance between the fixing parts on both sides is equal to the distance between the two sides of the circumference), so it can be not restricted by the fixing part 211, and will be concave toward the central axis when subjected to the radial force toward the axis. The first part 221 forms a blocking part, and when the first part 221 is in a retracted state, it is concave toward the central axis, reducing the flow cross-sectional area of ​​the adjustment tube 220. The adjustment tube 220 is divided into two first parts 221 facing each other by the two fixing parts 211. When the two first parts 221 are recessed toward the central axis, the parts located near the central axis contact each other and block the channel there; and the parts of the first part 221 located near the fixed part 211 are pulled by the first vertical rod 213 and the second vertical rod 214 and cannot contact each other, forming two sub-channels 230 with roughly triangular cross-sections. The sub-channel 230 can make the two first parts 221 incompletely contact, avoiding adhesion between the two due to cardiac tissue hyperplasia; and the cross-sectional area of ​​the sub-channel 230 is small, and the fluid flow back to the inlet 113 through it will not have a significant impact. At this time, the shunt channel includes the sub-channel 230, and the sum of the cross-sectional areas of the sub-channel 230 is the first flow cross-sectional area of ​​the shunt channel. When the pressure fluid flows in from the inlet 113 under the action of the pressure difference, forcing the first part 221 to change to an open state, it arches in the direction away from the central axis, so that the shunt channel has a larger second flow cross-sectional area.

[0061] The above arrangement can make the blocking part have the following functions: when the fluid pressure in the diverter 100 is less than the fluid pressure outside the flow regulating mechanism 200, the blocking part is driven by the fluid pressure outside the flow regulating mechanism 200 to be radially concave, so that the flow regulating mechanism 200 is in a state of "restricting flow", that is, the first state. When the fluid pressure in the diverter 100 is greater than the fluid pressure outside the flow regulating mechanism 200, the blocking part is driven by the fluid pressure in the diverter 100 to open radially, so that the flow regulating mechanism 200 is in a state of "allowing flow", that is, the second state. Here, the outside of the flow regulating mechanism 200 is relative to the inside connected to the inlet of the diverter 100. It can be understood that in the first state, the fluid pressure directly acts on the outer surface of the blocking part. By setting a shaping frame, the first part 221 can be deformed in a controlled manner, so that it is concave and arched in the desired direction, avoiding the instability caused by the random deformation of the regulating soft cylinder. In the initial state, that is, before being implanted into the human body, since the blocking portion has a certain degree of freedom, it 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.

[0062] In some optional embodiments, the shunt channel may be formed only by the bracket 110 and the shunt soft 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 may 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 inlet of the shunt member (which can also be understood as the fluid pressure near the inlet of the shunt member) is less than the fluid pressure outside the flow regulating mechanism (which can also be understood as the fluid pressure near the outlet of the shunt member), the blocking portion is driven by the fluid pressure outside the flow regulating mechanism to contract radially so that the flow regulating mechanism is in the first state. When the fluid pressure at the inlet of the shunt member is greater than the fluid pressure outside the flow regulating mechanism, the blocking portion is driven by the fluid pressure at the inlet of the shunt member to open radially so that the flow regulating mechanism is in the second state.

[0063] Preferably, the first vertical rod 213 and the second vertical rod 214 gradually approach each other from the annular frame to the horizontal rod 215. With this design, the regulating tube 220 can be changed step by step between the first state and the second state in response to the pressure change, thereby more reasonably adjusting the flow of the fluid flowing through the shunt channel, achieving the purpose of low-flow shunt under low pressure and high-flow shunt under high pressure, and 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 required flow control method.

[0064] 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 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 existence of the sub-channels 230, the first part 221 is difficult to adhere together, thereby avoiding the formation of neointimal hyperplasia along the edge of the regulating soft tube from the edge of the fixed part, thereby avoiding permanent blocking of the shunt channel.

[0065] In some optional embodiments, the first portion 221 may have different degrees of depression by adjusting the size of the first portion 221, thereby adjusting the degree of restriction on the fluid in the first state and the closed state of the first portion 221. Figure 3 and Figure 4 . Figure 3 is a schematic diagram of a second state of the flow regulating mechanism 200 in an optional implementation manner, Figure 4 yes Figure 3 Schematic diagram of the flow regulating mechanism 200 in the first state. Increasing the distance between the first vertical rod 213 and the second vertical rod 214 can make the width W of the second part 222 larger, thereby increasing the flow cross-sectional area of ​​the sub-channel 230; and the degree of depression that the first part 221 can eventually reach will also be reduced. In extreme cases, the two first parts 221 no longer contact each other, and a slit is formed between them. Further, by controlling the size of the flexible tube 220, the following can be achieved: Figure 2 The preferred closed state shown. Specifically, the axial length dimension of the first part 221 of the adjusting soft tube 200 is smaller than the axial length dimension of the second part 222, which is helpful to form the subchannel 230. The edge profile of the first part 221 can be a curve and has a minimum length dimension h in the middle position, the edge profile of the second part 222 is a curve connected to the edge profile of the first part 221 and has a maximum length dimension H in the middle position, and the ratio range of h to H can be selected between 0.3 and 1 according to the situation. Further, the edge profile of the first part 221 is a curve concave toward the inlet 113, and the edge profile of the second part 222 is a curve smoothly connected to the edge profile of the first part 221. The axial dimension of the part of the first part 221 away from the fixing part 211 is smaller than the dimension of the part close to the fixing part 211. At this time, when the ratio of h to H is less than 1 and the maximum length dimension H is greater than the spacing D between the two fixings (or the diameter of the adjusting soft tube 220), it is helpful to improve the matching form of the coating and reduce wrinkles. The ratio of H to D can be selected in the range of 0.5 to 3.

[0066] In other optional embodiments, the number of the fixing parts 211 can be three or more, and the adjusting soft tube 220 can be divided into three or more first parts 221 and three or more second parts accordingly, forming three or more sub-channels, and the first part 221 can limit the fluid flow of the shunt channel as a blocking part. In other optional embodiments, the adjusting soft tube 220 can also be sleeved on the outside of the shaping frame 210. In other optional embodiments, the adjusting soft tube 220 and the shunt soft tube 120 are separate, and can be formed by laying and / or winding two different films respectively.

[0067] refer to Figure 5 , Figure 5 It is a structural schematic diagram of a diverter device according to another embodiment of the present disclosure. In the diverter device in this embodiment, the diverter 100 is the same as the aforementioned diverter, and the flow regulating mechanism 200a includes a shaping frame 210a and an adjusting soft 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 fixed portions 211a. Compared with the shaping frame formed by cutting a metal tube, the shaping frame formed by bending a metal wire has better pressing and gripping performance and is easy to assemble and transport. The fixed 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 fixed portions 211a is equal to the diameter of the bracket 110 in the diverter 100. Preferably, the regulating soft tube 220a and the shunt soft tube 120 in the shunt member 100 are the same coating, which reduces the additional implant material, thereby reducing the inflammatory response and reducing the risk of stenosis. The regulating soft 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, so as to remain in a arched state. In some optional embodiments, the regulating soft tube 220a can also be coated outside the shaping 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 an obvious cross bar, the second portion 222a with a predetermined width can be formed, and the two first portions 221 close to 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 close to the fixing portion 211a, so that when the two opposite second portions 222a are close to each other, a second portion 222a having a predetermined width can be formed. Figure 2 The apposition state shown reduces wrinkles and further avoids neointimal hyperplasia.

[0068] In some other optional embodiments, the shaping frame can also be integrally formed with the adjustable flexible tube. For example, a reinforcing structure equivalent to the fixing portion 211a is provided in the tube wall of the adjustable flexible tube, and such reinforcing structure can also be formed by part of the tube wall of the adjustable flexible tube (for example, by thermoplastic technology), as long as all relevant structural parts can be formed in the end.

[0069] refer to Figure 6a and Figure 6b , Figure 6a is a schematic structural diagram of a flow diversion device according to another embodiment of the present disclosure, Figure 6b yes Figure 6a BB cross-sectional view in FIG. The flow regulating mechanism is in the first state. The flow dividing device in this embodiment, the flow dividing member 100 is the same as the aforementioned flow dividing 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 soft cylinder 220f are formed into an initial state through pre-forming, and the initial state is the first state, and the regulating soft cylinder 220f has a smaller first flow cross-sectional area. Figure 7 yes Figure 6a The flow regulating mechanism of the shunt device is in the second state. At this time, the pressure of the left atrium is higher than that of the right atrium. Under the action of the pressure difference, the blood flow can enter the shunt member 100 and push the regulating tube 220f radially to enter the right atrium, thereby realizing the shunt function. When the pressure of the left atrium is lower than that of the right atrium, the blood flow of the right atrium tends to enter the left atrium, so the regulating tube 220f is pressed from the outside. At the same time, under the action of the predetermined shape, the regulating tube 220f returns to the predetermined shape state, thereby limiting the blood flow from further entering the left atrium.

[0070] 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 the initial state, one end of the elastic thread is connected and the positive projection of the end can be connected to 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 frame 211f extends axially and gradually approaches the central axis to form an elastic cantilever inclined to the central axis. Preferably, these elastic threads are integrally formed, that is, formed by one thread. The shaping frame is fixed to the adjustment tube through processes such as suturing or hot pressing. Under the restriction of the elastic guide frame 211f, the first part 221f of the adjustment tube is set to be able to be recessed and arched in the radial direction to become a blocking portion, while the second part 222f is not restricted by the elastic guide frame 211f and maintains the arched state.

[0071] In the initial state, the flow regulating mechanism forms a first state, that is, it is in a "restricted flow" state. In this embodiment, the shaping frame 210f includes six elastic guide frames 211f, so that the regulating tube 220f can be divided into 12 parts, namely six first parts 221f and six second parts 222f. In the first state, a petal-shaped structure is formed. The elastic guide frame 211f includes a first vertical rod 213f and a second vertical rod 214f. The first part 221f is located between the first vertical rod 213f and the second vertical rod 214f. The second part 222f is located between two adjacent elastic guide frames 211f. Figure 7 As shown, when blood flows out of the flow regulating mechanism 200f from the entrance of the shunt member 100 through the shunt channel, the blood can push the shaping frame to expand radially outward, and the regulating soft tube gradually arches according to the change of the pressure difference on both sides until it returns to a cylindrical shape. The shunt channel has a second flow cross-sectional area, and the flow regulating mechanism 200f is in the second state, that is, the "flow allowed" state.

[0072] It is understandable that in other embodiments, the second part 222f of the partial regulating soft cylinder 220f may be removed, that is, the regulating soft cylinder may also have only the first part 221f forming the blocking portion, and the first part 221f is swung radially 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 part 221f is driven by the pressure fluid outside the flow regulating mechanism 200f to contract radially 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 part 221f is driven by the pressure fluid inside the diverter 100 to open radially so that the flow regulating mechanism 200f is in the second state. Specifically, when the first portion 221f is in the initial state, i.e., the retracted state, the flow regulating mechanism 200f is in the first state, and 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 the open state, and the flow regulating mechanism 200f is in the second state. At this time, the first flow cross-sectional area of ​​the diversion channel can be adjusted by adjusting the adjacent elastic guide frame.

[0073] In other embodiments, elastic sheets can be used instead of elastic wires, the elastic guide frame can also be in sheet shape or in the shape of a separate elastic wire, fixed to an annular frame, and 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.

[0074] refer to Figures 8a to 8d, which shows schematic diagrams of flow regulation mechanisms in various optional ways.

[0075] Figure 8a It is a schematic diagram of the structure of the flow regulating mechanism in an optional embodiment. In this embodiment, the shaping frame includes three elastic guide frames 211b uniformly distributed in the circumferential direction. The starting end of the regulating flexible cylinder is circular and connected to the diverter, and the end is pressed down to the central axis by the three elastic guide frames 211b to be shaped into a Y shape. In other words, the initial state of the flow regulating mechanism is the first state, that is, in the state of "restricting flow". The three second parts 222b at the end of the regulating flexible cylinder remain in their original state, and the first part 221b between two adjacent second parts 222b is compressed by the elastic guide frame 211b. An elastic guide frame 211b is formed by two elastic wires. One end of the elastic wire is fixed to the circumferential surface of the diverter, and the other end extends axially and gradually approaches the central axis to form an elastic cantilever inclined to the central axis; the elastic guide frame 211b can reach a state parallel to the central axis when subjected to radial outward force. The three elastic guide frames 211b make part of the structure of the regulating flexible cylinder gather toward the center of the diverter channel to form a Y-shaped outlet. When the pressure fluid from the diverter passes through the Y-shaped flow cross section, the pressure fluid can drive the first part 221b and the elastic guide frame 211b to expand outward, thereby expanding the flow cross-sectional area. After the pressure fluid in this direction disappears, the elastic guide frame 211b drives the first part 221b to reset the flow regulating mechanism to the first state, thereby limiting the reverse pressure fluid flow.

[0076] Figure 8b FIG. 1 is a schematic diagram of the structure of the flow regulating mechanism in another optional embodiment. In this embodiment, the flow regulating mechanism and Figure 8a The structure shown in is similar to that shown in , except that the number of the elastic guide frames 211c is four, and the number of the first part 221c and the second part 222c is also four. In the first state, the flow cross-section formed by the end of the regulating flexible cylinder is in an X shape.

[0077] Figure 8c 2 is a schematic diagram of the structure of the flow regulating mechanism in another optional embodiment. In this embodiment, the width of the second part 222e is substantially equal to the width of the first part 221e. There are two elastic guide frames 211e, and the distance between the ends of the two is relatively large. In this way, the distance between the two first parts 221e is relatively large, and the restriction effect on the pressure fluid is relatively small.

[0078] Figure 8dIt is a schematic diagram of the structure of the 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 small in distance, and a part of the regulating soft cylinder between the two is completely gathered together, and this part is the first part 221d. The second part 222d located between the two pairs of clamping structures forms a shunt channel with a smaller diameter, and the regulating soft cylinder can expand under the push of the pressure fluid from the shunt cylinder (while pushing the elastic guide frame 211d), thereby opening the first part 221d.

[0079] In other embodiments, suitable materials may be selected to form the blocking portion through pre-forming (that is, the forming frame and the blocking portion are integrally formed) 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).

[0080] It is understandable that in the above embodiments, at an instant, when the fluid pressure at the inlet and / or inside of the flow divider is equal to the fluid pressure outside the flow regulating mechanism, the blocking portion will remain unchanged in the state it was in under the pressure gradient at the previous moment. For example, when at the previous moment, the fluid pressure at the inlet and / or inside of the flow divider is greater than the fluid pressure outside the flow regulating mechanism, the blocking portion is driven by the fluid pressure at the inlet and / or inside of the flow divider to open radially to place the flow regulating mechanism in the second state, then at the next moment, if the fluid pressure at the inlet and / or inside of the flow divider is equal to the fluid pressure outside the flow regulating mechanism, the blocking portion remains in the second state.

[0081] refer to Fig. 9 , Fig. 9 : is a schematic diagram of the structure of a shunt device according to another embodiment of the present disclosure. 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 member 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, the treatment and diagnosis functions can be realized at the same time.

[0082] The above is only a specific embodiment of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any person skilled in the art who is familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present disclosure, which should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope 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 includes an adjusting soft cylinder connected to the diverter member, the cylinder wall of the adjusting soft cylinder includes a first part distributed in the circumferential direction, the first part is a morphologically variable blocking part, which is used to change the flow cross-sectional area of ​​the diverter channel, and the flow regulating mechanism will never completely close the diverter channel.

2. The flow dividing device according to claim 1, characterized in that: 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 diversion channel has a first flow cross-sectional area. In the second state, the blocking portion is in an open state so that the diversion 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.

3. The flow dividing device according to claim 1, characterized in that: When the blocking portion is in a retracted state, the blocking portion is deformed into a recessed state, and when the blocking portion is in an open state, 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 put the flow regulating mechanism in a retracted state when the fluid pressure at the inlet and / or inside the diverter is less than the fluid pressure outside the flow regulating mechanism.

4. The flow dividing device according to claim 1, characterized in that: The regulating soft cylinder also includes a second part, which is distributed circumferentially and spaced apart from the first part; the flow regulating mechanism also includes a shaping frame, which keeps 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.

5. The flow dividing device according to claim 4, characterized in that: The shaping frame supports a predetermined part of the adjusting soft tube so that the second part maintains the arched state. The shaping frame includes a plurality of fixing parts, one end of which is connected to the diverter and the other end of which extends axially. The plurality of fixing parts are distributed in the circumferential direction of the adjusting soft tube. 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.

6. The flow dividing device according to claim 5, characterized in that: The width of the fixing portion is consistent with the width of the second portion, the adjusting soft tube is arranged on the inner side and / or the outer side of the fixing portion, the width of the first portion is greater than the straight-line distance between the two fixing portions on both sides of the first portion, and when the first portion is in a retracted state, a slit is formed between the first portions; the distance between the two fixing portions is equal to the diameter of the adjusting soft tube.

7. The flow dividing device according to claim 5, characterized in that: The fixing portion includes a first vertical rod and a second vertical rod connected to each other, a predetermined distance between the first vertical rod and the second vertical rod, the second portion is located 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.

8. The flow dividing device according to claim 7, 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.

9. The flow dividing device according to claim 4, 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, the ratio of the minimum length dimension to the maximum length dimension ranges from 0.3 to 1, and / or the ratio of the minimum length dimension to the diameter of the adjustment tube ranges from 0.5 to 3.

10. The flow dividing device according to claim 5, 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.

11. The flow dividing device according to claim 1, 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.

12. The flow dividing device according to claim 1, 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.

13. The flow dividing device according to claim 12, 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; in the initial state, part of the structure of the regulating soft tube gathers toward the center of the diversion channel and forms a petal-shaped structure or a Y-shaped or X-shaped outlet, or part of the regulating soft tube is completely retracted together.

14. The flow dividing device according to claim 12, characterized in that: The cylinder wall of the regulating soft cylinder also includes a second part distributed in the circumferential direction, and the second part and the first part are distributed in the circumferential direction and spaced from each other; the first part is configured to be able to be recessed or arched in the radial direction, and the elastic guide frame enables the second part to always maintain a arched state.

15. The flow dividing device according to claim 14, 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; there are multiple elastic guide frames, and each of the elastic guide frames includes a first vertical rod and a second vertical rod, the first part is located between the first vertical rod and the second vertical rod, and the second part is located between two adjacent elastic guide frames.

16. The flow dividing device according to claim 4 or 12, 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.

17. The flow dividing device according to claim 1, characterized in that: The number of the blocking parts is plural, and the initial state of the flow regulating mechanism is a retracted state or an open state.

18. The flow dividing device according to claim 1, characterized in that: The main body includes a bracket and a diverter tube, the diverter tube is formed by a coating applied on the inner surface and / or outer surface of the bracket, the diverter tube and the regulating tube are formed integrally, the bracket is connected to the flow regulating mechanism at the outlet, the bracket and the diverter tube form the first section of the diverter channel, and the regulating tube forms the second section of the diverter channel.

19. The flow dividing device according to claim 1, 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.

20. The flow dividing device according to claim 1, characterized in that: The flow regulating mechanism is arranged inside the flow dividing member.

Images