An interventional circulatory assist system
By designing an interventional circulatory support system with catheters, pumps, and T-junctions, selective shunting is achieved through the use of turning channels and branching structures, solving the problems of blood stagnation and structural fatigue in existing devices, and improving the safety and applicability of interventional cardiac treatment.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- HANGZHOU DIYUAN MEDICAL TECH CO LTD
- Filing Date
- 2022-10-25
- Publication Date
- 2026-06-30
AI Technical Summary
Existing percutaneous mechanical circulation devices suffer from problems such as blood stasis, coagulation, and structural fatigue failure in cardiac interventional therapy, and are not suitable for patients with aortic aneurysms.
An interventional circulatory support system was designed, which adopts a catheter, pump tube and three-way tube structure. It achieves selective diversion of fluid through a turning flow channel, a first branch and a second branch, avoiding movable mechanical structures and reducing the risk of blood stagnation and coagulation.
It achieves selective shunting without mechanical failure, improves blood flow efficiency, reduces thrombus formation, and is suitable for a wider range of patients, including those with aortic aneurysms.
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Figure CN117959582B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of interventional therapy technology, and in particular to an interventional circulatory support system. Background Technology
[0002] For high-risk, complex coronary artery disease patients, myocardial ischemia caused by transient blood flow occlusion during percutaneous coronary intervention (PCI) or increased cardiac load due to contrast agent injection can lead to circulatory collapse and even sudden death. Prophylactic implantation of a percutaneous mechanical circulatory assist device can partially improve cardiac function, increase myocardial blood supply, and enhance tolerance to myocardial ischemia. This ensures effective circulation is maintained even in the event of circulatory collapse, guaranteeing a smooth procedure and promoting postoperative recovery.
[0003] In related technologies, percutaneous mechanical circulation devices include interventional pumps and intra-aortic balloon pumps. The working principle of an interventional pump is to pump blood from the ventricles into the aorta by percutaneously inserting a mechanical pump; due to the small size of the mechanical pump, blood may stagnate in the gaps inside the pump body as it passes through, leading to coagulation.
[0004] The working principle of intra-aortic balloon counterpulsation is to insert a balloon into the aorta. When the aortic valve closes, the balloon inflates and squeezes blood into the blood vessel, thereby improving the blood perfusion of the organ. During the inflation process, the balloon may come into large contact with the blood vessel wall, which may cause vascular damage. Therefore, it is not suitable for patients with aortic aneurysms.
[0005] In other related technologies, percutaneous mechanical circulatory systems draw blood from the heart during systole, store it in an external membrane pump, and then reinfuse it into the aorta during diastole. The blood draw and transfusion processes occur within the same tubing, with valves preventing blood from being drawn from the aorta during draw or entering the ventricles during transfusion. Because percutaneous mechanical circulatory systems are interventional devices, the valves and the pivot pins supporting their rotation must be very small. Frequent opening and closing of the valves during operation can lead to fatigue failure of the pivot pins. Additionally, blood may stagnate in the gaps between the tubing and valves or between the pivot pins as it flows through the tubing, potentially causing clotting. Summary of the Invention
[0006] In view of this, embodiments of this application aim to provide an interventional circulatory support system that does not contain movable mechanical structures and can achieve selective diversion.
[0007] To achieve the above objectives, the technical solution of this application embodiment is implemented as follows:
[0008] An interventional circulatory support system, comprising:
[0009] The catheter has an inlet at its proximal end;
[0010] Pump tubing and external pump;
[0011] A three-way connector is provided, which connects the catheter and the pump tube. The end of the pump tube away from the three-way connector is connected to the external pump. The wall of the three-way connector is provided with an outlet for communication with the aorta. The flow channels in the three-way connector include a first channel communicating with the catheter and a second channel communicating with the external pump.
[0012] The three-way pipe has a protruding guide portion on the pipe wall around the outlet. The guide portion defines a turning flow channel at one end of the second channel near the outlet and forms a first branch at the end of the first channel. The end of the turning flow channel forms a second branch. At least a portion of the outlet is located in the fluid outflow direction of the second branch.
[0013] In some implementations, the turning angle of the turning channel does not exceed 90°.
[0014] In some implementations, the first channel near the outlet forms a first contraction section, and the end of the first contraction section forms the first fork.
[0015] The second channel has a second contraction section at one end near the outlet. In the direction of fluid flow in the second channel toward the outlet, the cross-sectional area of the second contraction section decreases sequentially and its end is connected to the turning channel.
[0016] In some implementations, the cross-sectional shape of the first channel and the second channel is polygonal, and the turning angle of the turning channel is 45° to 80°.
[0017] In some embodiments, with an X-axis coaxial with the central axis of the tee, a Y-axis orthogonal to the X-axis, and a Z-axis orthogonal to both the X-axis and the Y-axis defined, the Y-axis passes through the outlet;
[0018] Within the XY plane defined by the X and Y axes, the width of the first fork is not less than the width of the second fork, the width of the first fork is the dimension along the Y-axis, and the width of the second fork is the dimension along the X-axis.
[0019] In some implementations, the width of the first fork is 1.1 to 1.4 times the width of the second fork.
[0020] In some implementations, within the XY plane defined by the X and Y axes, the width of the outlet is 1-3 times the width of the second fork.
[0021] In some embodiments, the inner surface of the tee tube has a first inner wall and a second inner wall, the outlet is disposed on the first inner wall, and the second inner wall faces the first inner wall;
[0022] The flow guide includes a first flow guide and a second flow guide separated from each other. The first flow guide is disposed on the first inner wall and extends toward the side where the second inner wall is located. The second flow guide is disposed on the second inner wall and extends toward the side where the first inner wall is located. The gap between the first flow guide and the second flow guide forms the turning flow channel. A second contraction section is defined between the surface of the first flow guide on the side where the second side wall is located and the second inner wall. A first contraction section is defined between the surface of the first flow guide on the side where the first inner wall is located and the first inner wall.
[0023] In some implementations, a flow divider is provided in the turning channel, which divides the turning channel into two sub-channels, and the two sub-channels are arranged at intervals along the width direction of the turning channel.
[0024] In some implementations, one end of the diverting block passes through the second fork and extends toward the outlet, the diverting block protruding from the end of the second guide near the outlet and not exceeding 30% of the width of the first fork.
[0025] In some implementations, the cross-sections of the first channel and the second channel are circular, and the turning angle of the turning channel is 85° to 90°.
[0026] In some embodiments, the flow guide includes a housing portion disposed within a transition channel between the end of the turning flow channel and the outlet, and covering the area around the first fork.
[0027] In some embodiments, a diversion section is provided on the side of the casing facing the end of the turning channel, the diversion section being used to guide the fluid flowing out of the turning channel toward the circumferential sides of the casing.
[0028] In some embodiments, the sidewall of the housing portion extending obliquely toward the outlet direction on one side of the turning channel, the diverting portion having a first inclined surface and a second inclined surface, the first inclined surface intersecting the second inclined surface, and the intersection line defining a diverting ridge, the diverting ridge extending obliquely from the radially outer sidewall of the turning channel toward the axial end face of the housing portion, the first inclined surface and the second inclined surface being located on opposite sides of the diverting ridge along the circumference of the housing portion.
[0029] In some implementations, the size by which the housing portion extends into the transition channel does not exceed half the width of the transition channel.
[0030] The interventional circulation auxiliary system provided in this application embodiment does not contain movable mechanical structures and has no structural failure issues. The three-way pipe contains structures such as a turning channel, a first branch, and a second branch. The fluid is turned and accelerated at the turning channel and the second branch, ultimately achieving selective diversion. Attached Figure Description
[0031] Figure 1 This is a schematic diagram of the structure of an interventional circulatory support system in one embodiment of this application;
[0032] Figure 2 for Figure 1 The diagram shows the location of the interventional circulatory support system inside and outside the body.
[0033] Figure 3 for Figure 1 The diagram shows the preparation before the interventional circulatory support system is inserted into the human body.
[0034] Figure 4 for Figure 1 The diagram shows the structural schematic of the process of implanting an interventional circulatory support system into the human body.
[0035] Figure 5 for Figure 1 The diagram shows the structure of the interventional circulatory support system after it has been implanted into the human body.
[0036] Figure 6 for Figure 1 The diagram shows a simplified schematic of a three-way valve, where the arrows indicate the direction of blood flow during blood collection.
[0037] Figure 7 for Figure 1 The diagram shows a simplified schematic of a three-way valve, where the arrows indicate the direction of blood flow during transfusion.
[0038] Figure 8 for Figure 1 A schematic diagram of the external shape and internal flow channel shape of the first embodiment of the tee pipe shown;
[0039] Figure 9 for Figure 8 A cross-sectional schematic diagram of the internal flow channel of the first embodiment of the tee pipe shown.
[0040] Figure 10 for Figure 1 A schematic diagram of the external shape and internal flow channel shape of the second embodiment of the tee pipe shown;
[0041] Figure 11 for Figure 10 A cross-sectional schematic diagram of the internal flow channel of the second embodiment of the tee pipe shown.
[0042] Figure 12 For blood drawing conditions Figure 11 A schematic diagram of the flow field distribution near the turning channel is shown.
[0043] Figure 13 For blood transfusion conditions Figure 11 A schematic diagram of the flow field distribution near the turning channel is shown.
[0044] Figure 14 for Figure 1 A schematic diagram of the external shape and internal flow channel shape of the third embodiment of the tee pipe shown;
[0045] Figure 15 for Figure 14 A cross-sectional schematic diagram of the internal flow channel of the third embodiment of the tee pipe shown.
[0046] Explanation of reference numerals in the attached figures
[0047] 1-Interventional Circulation Assist System; 10-Catheter; 10a-Inlet; 11-Pump Tube; 12-Extracorporeal Pump; 121-Outer Shell; 122-Elastic Membrane; 123-Air Inlet / Outlet; 124-Liquid Chamber; 125-Air Chamber; 13-Tee Tube; 13a-First Inner Wall; 13b-Second Inner Wall; 131-Outlet; 132-First Channel; 1321-First Contraction Section; 1321a-First Fork; 133-Second Channel; 13 31-Turn flow channel; 1331', 1331”-Sub-flow channel; 1331a-Second branch; 1332-Second contraction section; α-Turn angle; 134-Guide section; 1341-First guide section; 1342-Second guide section; 1343-Shell section; 135-Transition section; 136-Band block; 137-Band section; 1371-First inclined surface; 1372-Second inclined surface; 1373-Band ridge; 14-Converter;
[0048] 2-Left ventricle;
[0049] 3-Aorta; 31-Aortic valve;
[0050] 4-Guidewire;
[0051] 5- Multilumen catheter. Detailed Implementation
[0052] It should be noted that, unless otherwise specified, the embodiments and technical features in the embodiments of this application can be combined with each other, and the detailed descriptions in the specific implementation should be understood as explanations of the purpose of this application and should not be regarded as undue limitations on this application.
[0053] In the description of the embodiments of this application, it should be noted that the terms "inner" and "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.
[0054] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature; in the description of this application, unless otherwise stated, "multiple" means two or more.
[0055] Please see Figure 1 This application provides an interventional circulatory support system 1, which includes a catheter 10, a pump tube 11, an external pump 12, and a three-way tube 13.
[0056] The proximal end of the conduit 10 is provided with an inlet 10a; exemplarily, the inlet 10a is located on one side of the conduit 10 in the circumferential direction, which can increase the flow area of the inlet 10a. Please refer to [reference needed]. Figure 2 The catheter 10 is clamped in the middle of the aortic valve 31 to act as an anchor, and the inlet 10a is placed in the left ventricle 2.
[0057] Please see Figure 1 and Figure 2 The three-way tube 13 connects the catheter 10 and the pump tube 11, and the end of the pump tube 11 away from the three-way tube 13 is connected to the external pump 12.
[0058] The connection method between the pump tubing 11 and the external pump 12 is not limited. The pump tubing 11 can be directly connected to the external pump 12, or the pump tubing 11 can be connected to the external pump 12 via a connector. For example, please refer to [link to relevant documentation]. Figure 1 and Figure 2 The pump tube 11 is connected to the external pump 12 via the converter 14. These three parts can be disassembled and assembled, which also facilitates the subsequent cleaning and replacement of the pump tube 11 and the external pump 12.
[0059] The wall of the three-way tube 13 is provided with an outlet 131 for communication with the aorta 3. The flow channels of the three-way tube 13 include a first channel 132 communicating with the catheter 10 and a second channel 133 communicating with the external pump 12. The three-way tube 13 allows the interventional circulatory support system 1 to extract or deliver fluid from different channels.
[0060] The external pump 12 has no structural limitations. For an example, please refer to [link to example]. Figure 1The external pump 12 includes a housing 121, an elastic membrane 122, and an air inlet / outlet 123. The elastic membrane 122 divides the space inside the housing 121 into two non-communicating chambers, namely a liquid chamber 124 and an air chamber 125. The external pump 12 draws in and draws out air through the air inlet / outlet 123, driving the elastic membrane 122 to move, thereby discharging fluid from the liquid chamber 124 or drawing out fluid and storing it in the liquid chamber 124. During blood drawing and transfusion, the external pump 12 can provide some of the work required to transport blood, reducing the burden on the heart and ensuring that sufficient blood can still be provided when the heart's power is insufficient.
[0061] Please see Figure 9 , Figure 11 and Figure 15 The three-way pipe 13 has a protruding guide portion 134 on its wall around the outlet 131. The guide portion 134 defines a turning channel 1331 at one end of the second channel 133 near the outlet 131 and forms a first branch 1321a at the end of the first channel 132. A second branch 1331a is formed at the end of the turning channel 1331. At least a portion of the outlet 131 is located in the fluid outflow direction of the second branch 1331a. The arrangement of the turning channel 1331, the first branch 1321a, and the second branch 1331a allows the fluid to be turned and accelerated when flowing out of the second channel 133, thereby achieving flow diversion.
[0062] After the fluid flows out from the second branch 1331a, the resistance to flow toward the first branch 1321a is greater than the resistance to flow toward the outlet 131. Therefore, the fluid tends to flow toward the outlet 131 where the resistance is lower. At least a portion of the outlet 131 is located in the fluid outflow direction of the second branch 1331a, which facilitates the fluid to flow more smoothly into the outlet 131 after flowing out from the second branch 1331a.
[0063] Taking blood drawing and transfusion as examples, this paper briefly describes the process and working method of inserting an interventional circulatory support system 1 into the left ventricle 2 of the human body.
[0064] The procedure for implanting the interventional circulatory support system 1 into the left ventricle 2 of the human body: Please refer to Figure 3 Before inserting the interventional circulatory support system 1 into the left ventricle 2, guidewire 4 is first inserted into the left ventricle 2 along the aorta 3; a multi-lumen catheter 5 is selected, and guidewire 4 is inserted into the smaller lumen of the multi-lumen catheter 5, and the multi-lumen catheter 5 is then extended into the left ventricle 2 along guidewire 4; please refer to Figure 4 By disassembling the converter 14, the interventional circulatory support system 1 is divided into three parts. All three parts are placed in saline solution, filling the internal chambers to prevent air from entering the body. The portion of the device containing the catheter 10, the three-way connector 13, and the pump tubing 11 is then inserted into the larger chamber of the multi-lumen catheter 5 and advanced along the multi-lumen catheter 5 into the left ventricle 2. (See also...) Figure 5After confirming the proper placement of the device in contrast images or ultrasound images, the multi-lumen catheter 5 and guidewire 4 are removed, and the pump tube 11, converter 14 and extracorporeal pump 12 are assembled into a complete interventional circulatory support system 1.
[0065] The working process of the interventional circulatory support system 1 during blood draw: The external pump 12 draws gas from the air chamber 125 through the air inlet / outlet 123, driving the elastic membrane 122 to move towards the air chamber 125. This creates negative pressure in the liquid chamber 124. At this time, the left ventricle 2 is in a contracted state. The catheter 10 draws blood from the left ventricle 2 and also draws blood from the aorta 3 through the outlet 131 of the three-way tube 13. The blood flows into the second channel 133 of the three-way tube 13, then into the pump tube 11, and finally into the liquid chamber 124 for storage. Please refer to [link to relevant documentation]. Figure 6 , Figure 6 The arrows in the diagram indicate the direction of blood flow during blood collection. The size of the arrows indicates the blood flow rate of each channel in the three-way tube 13. The blood flow rate of the catheter 10 is higher than that of the outlet 131.
[0066] The working process of the interventional circulatory support system 1 during blood transfusion: The external pump 12 draws in gas through the inlet / outlet 123 into the air chamber 125, driving the elastic membrane 122 to move towards the liquid chamber 124. Positive pressure is generated in the liquid chamber 124, and the blood stored in the liquid chamber 124 flows through the pump tube 11 to the turning channel 1331 and the second branch 1331a within the three-way tube 13, causing most of the blood to flow from the outlet 131 into the aorta 3, with only a small portion entering the left ventricle 2. (See also...) Figure 7 , Figure 7 The arrows in the diagram indicate the direction of blood flow during transfusion, and the size of the arrows indicates the flow rate of each channel. The blood flow rate entering the aorta 3 is much greater than the blood flow rate entering the left ventricle 2.
[0067] The interventional circulatory support system 1 alternates between blood drawing and transfusion within the same conduit throughout the entire process. When the external pump 12 generates negative pressure, the left ventricle 2 contracts, drawing blood from the left ventricle 2 and the aorta to external storage. When the external pump generates positive pressure, the previously stored blood is reinfused into the body. At this time, the left ventricle 2 is in a diastolic state. During diastole, the pressure of the left ventricle 2 is lower than the pressure of the aorta 3, making it easier for blood flowing from the pump tube 11 to enter the side with lower pressure. That is, the tendency for blood to enter the left ventricle 2 is greater. Through the construction of the three-way tube 13, such as the turning channel 1331, the first branch 1321a, and the second branch 1331a, the blood flowing from the pump tube 11 is accelerated and overcomes the pressure difference to flow towards the aorta 3. Only a small portion of the blood enters the left ventricle 2, completing the blood supply to the aorta 3. Furthermore, because the blood is accelerated at the second branch 1331a or in the turning channel 1331, the scouring effect of the accelerated blood makes it less likely for thrombi to form.
[0068] The interventional circulation auxiliary system 1 of this application embodiment does not contain a movable mechanical structure and has no structural failure problem. The three-way pipe 13 contains a turning channel 1331, a first branch 1321a, a second branch 1331a and other structures. The turning channel 1331 and the second branch 1331a jointly realize the diversion and acceleration of the fluid, and finally achieve selective diversion.
[0069] In some embodiments, the turning angle α of the turning channel 1331 does not exceed 90°. The turning angle α is the angle between the flow direction of the fluid before it enters the turning channel 1331 and the flow direction of the fluid from the turning channel 1331 to the outlet 131. A turning angle α not exceeding 90° allows the fluid to turn towards the outlet 131 when it flows out of the first channel 132. For example, please refer to [link to relevant documentation]. Figure 9 The turning angle α of the turning channel 1331 is less than 90°.
[0070] In some embodiments, please refer to Figure 9 and Figure 11 The first channel 132 has a first contraction section 1321 at its end near the outlet 131, and the end of the first contraction section 1321 forms a first branch 1321a. The cross-sectional area of the first contraction section 1321 gradually decreases as the fluid flows from the first channel 132 towards the outlet 131. The second channel 133 has a second contraction section 1332 at its end near the outlet 131. The cross-sectional area of the second contraction section 1332 gradually decreases as the fluid flows from the second channel 133 towards the outlet 131, and its end connects to the turning channel 1331. Along the flow direction, the cross-sectional area of the second contraction section 1332 gradually decreases, which allows the fluid to accelerate into the turning channel 1331 and flow out toward the outlet 131. The cross-sectional area of the first contraction section 1321 gradually shrinks to form the first branch 1321a. This cross-sectional shrinkage design can provide sufficient space for the turning channel 1331, prevent the turning channel 1331 from merging with the first channel 132 too early, and at the same time reduce the flow rate into the first branch 1321a, ensuring that most of the fluid entering from the second channel 133 can flow out from the outlet 131.
[0071] In some embodiments, the inner surface of the three-way pipe 13 has a first inner wall 13a and a second inner wall 13b, with the outlet 131 disposed on the first inner wall 13a and the second inner wall 13b facing the first inner wall 13a.
[0072] The flow guide section 134 includes a first flow guide section 1341 and a second flow guide section 1342 separated from each other. The first flow guide section 1341 is disposed on the first inner wall 13a and extends toward the side where the second inner wall 13b is located. The second flow guide section 1342 is disposed on the second inner wall 13b and extends toward the side where the first inner wall 13a is located. The gap between the first flow guide section 1341 and the second flow guide section 1342 forms a turning channel 1331. A second contraction section 1332 is defined between the surface of the first flow guide section 1341 facing the second inner wall 13b and the second inner wall 13b. A first contraction section 1321 is defined between the surface of the first flow guide section 1341 facing the first inner wall 13a and the first inner wall 13a. The arrangement of the first flow guide section 1341 and the second flow guide section 1342 inside the three-way pipe 13 defines the first contraction section 1321, the second contraction section 1332, and the turning channel 1331. The structure is simple, occupies little space, and can complete the flow diversion.
[0073] The widths of the first branch 1321a and the second branch 1331a jointly affect the flow diversion effect of the tee pipe 13. The smaller the widths of the first branch 1321a and the second branch 1331a, the smaller the turning angle α and width of the turning channel 1331, and the easier it is for the fluid to flow to the outlet 131. At the same time, the smaller the width of the first branch 1321a, the higher the pressure head required by the external pump 12 in the second contraction section 1332 to drive the fluid. For some embodiments, please refer to [link to relevant documentation]. Figure 9 , Figure 11 and Figure 15 With the X-axis coaxial with the central axis of the three-way pipe 13, the Y-axis orthogonal to the X-axis, and the Z-axis orthogonal to both the X-axis and the Y-axis defined, the Y-axis passes through the outlet 131. Within the XY plane defined by the X-axis and Y-axis, the width of the first branch 1321a is not less than the width of the second branch 1331a, reducing the pressure head required by the external pump 12. For example, the width of the first branch 1321a is 1.1-1.4 times the width of the second branch 1331a, reducing the demand on the external pump 12 while ensuring sufficient fluid flows from the second channel 133 to the second channel 133 via the first branch 1321a.
[0074] Please see Figure 9 , Figure 11 The width of the first branch 1321a is the dimension along the Y-axis, and the width of the second branch 1331a is the width along the X-axis. Thus, the first branch 1321a is arranged approximately along the Y-axis, while the second branch 1331a is arranged approximately along the X-axis, which facilitates the flow of fluid from the turning channel 1331 to the outlet 131.
[0075] The cross-sectional shape of the tee 13 along the flow direction is not limited. In some embodiments, the cross-sectional shape of the first channel 132 and the second channel 133 is polygonal. For example, please refer to [link to relevant documentation]. Figure 9 and Figure 11 The first channel 132 and the second channel 133 have rectangular cross-sections along the flow direction. See other embodiments for details. Figure 15 The cross-sections of the first channel 132 and the second channel 133 along the flow direction are circular.
[0076] The following is a brief description of three embodiments of the three-way pipe 13 with reference to the accompanying drawings.
[0077] First embodiment:
[0078] Please see Figure 8 and Figure 9 From the outside, the three-way pipe 13 is a round pipe with holes cut in the side. In fact, the internal flow channel of the three-way pipe 13 is not a round pipe. The cross-section of the flow channel perpendicular to the flow direction is rectangular. The cross-sections of the conduit 10 and the pump pipe 11 are both circular. In order to better connect with the conduit 10 and the pump pipe 11, in this embodiment, a transition section 135 is set to connect with the conduit 10 and the pump pipe 11. The cross-section of the transition section 135 is circular, which can better connect tightly with the conduit 10 and the pump pipe 11, preventing the fluid from flowing out of the gap to the outside of the interventional circulation auxiliary system 1 and affecting its working reliability.
[0079] The smaller the turning angle α of the turning channel 1331, the easier it is for the fluid flowing into the second contraction section 1332 to flow out from the outlet 131. However, this requires the external pump 12 to provide a higher pressure head. In this embodiment, the turning angle α of the turning channel 1331 is set to 45°~80°, such as 45°, 48°, 50°, 56°, 60°, 63°, 70°, 75°, 80°, etc., to reduce the pressure head requirement of the external pump 12.
[0080] The width of the second branch 1331a determines the acceleration effect of the fluid. Assuming the pressure at outlet 111 is... The speed required to overcome that pressure for:
[0081] ,
[0082] in, The fluid density is given. The pipe expansion after the second branch 1331a causes fluid deceleration; therefore, to enhance the flow diversion effect and reduce the head requirements of the external pump 12, the maximum average flow velocity at the second branch 1331a is limited to 2. In this embodiment, the average flow velocity at the second branch 1331a is 1.3. -1.8 .
[0083] The location of outlet 131 is influenced by the turning channel 1331 and the second branch 1331a. At least a portion of outlet 131 is located in the fluid outflow direction of the second branch 1331a. In this embodiment, please refer to... Figure 9 The boundary on one side of outlet 131 is confined within the extension line of the turning channel 1331 and the first branch 1321a. If the width of outlet 131 is too small, it will increase the pressure head of the external pump 12; if it is too large, it will affect the flow diversion effect. In this embodiment, within the XY plane defined by the X-axis and Y-axis, the width of outlet 131 is 1-3 times the width of the second branch 1331a.
[0084] Second embodiment:
[0085] Please see Figure 10 and Figure 11 From the outside, the three-way pipe 13 is a round pipe with holes cut in the side. In fact, the internal flow channel of the three-way pipe 13 is not a round pipe. The cross section along the flow direction is rectangular. In this embodiment, a transition section 135 is provided to connect with the front and rear conduits 10 and pump pipe 11. The turning angle α of the turning flow channel 1331 is limited to within 90°, such as 0°, 30°, 60°, 90°, etc.
[0086] Before reaching the second branch 1331a, the average flow direction of the fluid is roughly aligned with the x-axis, while the direction of the pressure gradient to be overcome is aligned with the y-axis. Since the fluid changes direction directly from the second branch 1331a without guidance, the inconsistency between the average flow direction and the pressure gradient means that the fluid's kinetic energy cannot be used to overcome the pressure difference. It can only overcome the pressure difference through potential energy, i.e., hydrostatic pressure, ultimately requiring a higher pressure head to achieve fluid diversion and acceleration. In this embodiment, a flow divider 136 is provided within the turning channel 1331. The flow divider 136 divides the turning channel 1331 into two sub-channels 1331' and 1331'". These two sub-channels are arranged at intervals along the width of the turning channel 1331. The flow divider 136 ensures that the fluid is adequately guided and diverted before reaching the second branch 1331a, allowing the fluid's kinetic energy to overcome the pressure difference and reducing the pressure head required by the external pump 12.
[0087] Please see Figure 11 The sum of the minimum widths of the two sub-channels 1331' and 1331' of the turning channel 1331 is less than the width of the second branch 1331a in the first embodiment of the tee pipe 13. This requires a higher acceleration of the fluid; the acceleration of the fluid flowing from one of the sub-channels 1331' towards the outlet 131 must be no less than 1.8. The acceleration amplitude when flowing from another sub-channel 1331 toward outlet 131 is not less than 2. .
[0088] In this embodiment, one end of the diverter block 136 passes through the second branch 1331a and extends toward the outlet 131, thus ensuring sufficient guidance for fluid diversion. The protrusion of the diverter block 136 in the Y direction may obstruct fluid flow from the first channel 132 to the second channel 133. Therefore, while prioritizing the diversion of fluid, the protrusion of the diverter block 136 in the Y direction should be as small as possible. In this embodiment, the diverter block 136 protrudes from the end of the second guide portion 1342 near the outlet 131, and does not exceed 30% of the width of the first branch 1321a. This ensures sufficient guidance for fluid diversion without hindering fluid flow from the first channel 132 to the second channel 133.
[0089] For example, in the case of blood drawing and transfusion, please refer to [link / reference]. Figure 12 and Figure 13 , Figure 12 This diagram illustrates the flow field distribution in the turning channel 1331 under blood drawing conditions. The area within the circular frame represents a region of stagnant flow. Figure 13 The flow field distribution in the turning channel 1331 under blood transfusion conditions is shown. Blood flow is normal within the circular frame area, and the switching of operating conditions can prevent the formation of flow stagnation areas.
[0090] The table below compares the average pressure of the pump tube 11 and the shunting effect of the three-way tube 13 under blood drawing and transfusion conditions in the first and second embodiments of the three-way tube 13. It can be seen that the second embodiment of the three-way tube 13 has lower requirements for the external pump 12 and a better shunting effect.
[0091]
[0092] Third embodiment:
[0093] Please see Figure 14 and Figure 15 The internal flow channel of the three-way pipe 13 is a circular pipe. The cross-sections of the first channel 132 and the second channel 133 along the flow direction are circular. In this case, the acceleration effect of the circular pipe is linearly related to its cross-sectional area, i.e., inversely proportional to the square of its width. The turning angle α of the turning channel 1331 is 85°~90°, for example, 85°, 87°, 88°, 90°, etc. In this embodiment, the velocity of the fluid flowing from the turning channel 1331 towards the outlet 131 is... ~1.4 The width of the flow channel from the turning channel 1331 to the outlet 131 remains consistent. In this embodiment, the width of the turning channel 1331 is greater than that of the turning channel 1331 in the first and second embodiments. Therefore, when the turning angle α is large and the width of the turning channel 1331 is large, additional obstacles are needed to guide the flow in order to achieve a certain diversion effect.
[0094] In this embodiment, the guide portion 134 includes a sleeve portion 1343, which is disposed within the transition channel between the end of the turning channel 1331 and the outlet 131, and covers the area around the first branch 1321a. This allows fluid to flow in from the second contraction section 1332, pass through the turning channel 1331, and then be obstructed by the sleeve portion 1343 from flowing into the first channel 132. In this embodiment, the sleeve portion 1343 extends into the transition channel by no more than half the width of the transition channel, thus preventing the fluid flowing out from the second contraction section 1332 from flowing into the first channel 132, while also not hindering the flow of fluid from the first channel 132 and the outlet 131 into the second channel 133.
[0095] When the fluid turns and reaches the area below the casing 1343, it will slow down upon impacting the wall of the casing 1343, thereby forming a flow stagnation area. In this embodiment, a diversion section 137 is provided on the side of the casing 1343 facing the end of the turning channel 1331. The diversion section 137 guides the fluid flowing out of the turning channel 1331 to move towards both sides of the casing 1343 in the circumferential direction, thereby avoiding the formation of a flow stagnation area.
[0096] In this embodiment, the flow divider 137 has a first inclined surface 1371 and a second inclined surface 1372. The first inclined surface 1371 and the second inclined surface 1372 intersect, and the intersection line defines a flow divider 1373. The flow divider 1373 extends obliquely from the radially outer sidewall of the turning channel 1331 toward the axial end face of the housing portion 1343. The first inclined surface 1371 and the second inclined surface 1372 are located on opposite sides of the flow divider 1373 along the circumference of the housing portion 1343. The flow divider 1373 can guide the fluid flowing out of the turning channel 1331 to split into two streams that flow toward the first inclined surface 1371 and the second inclined surface 1372 respectively, thereby moving along both sides of the circumference of the housing portion 1343 and avoiding the formation of stagnant flow areas and fluid backflow.
[0097] In the description of this application, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the embodiments of this application. In this application, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Furthermore, without contradiction, those skilled in the art can combine different embodiments or examples described in this application, as well as features of different embodiments or examples.
[0098] The above description is merely a preferred embodiment of this application and is not intended to limit the application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.
Claims
1. An interventional circulatory auxiliary system, characterized in that, include: The catheter has an inlet at its proximal end; Pump tubing and external pump; A three-way connector is provided, which connects the catheter and the pump tube. The end of the pump tube away from the three-way connector is connected to the external pump. The wall of the three-way connector is provided with an outlet for communication with the aorta. The flow channels in the three-way connector include a first channel communicating with the catheter and a second channel communicating with the external pump. The three-way pipe has a protruding guide portion on the pipe wall around the outlet. The guide portion defines a turning flow channel at one end of the second channel near the outlet and forms a first branch at the end of the first channel. The end of the turning flow channel forms a second branch. At least a portion of the outlet is located in the fluid outflow direction of the second branch.
2. The interventional circulatory auxiliary system according to claim 1, characterized in that, The turning angle of the turning channel does not exceed 90°.
3. The interventional circulatory support system according to claim 1, characterized in that, The first channel forms a first contraction section at one end near the outlet, and the end of the first contraction section forms the first fork. The second channel has a second contraction section at one end near the outlet. In the direction of fluid flow in the second channel toward the outlet, the cross-sectional area of the second contraction section decreases sequentially and its end is connected to the turning channel.
4. The interventional circulatory support system according to claim 1, characterized in that, The first channel and the second channel have polygonal cross-sectional shapes, and the turning angle of the turning channel is 45°~80°.
5. The interventional circulatory support system according to claim 1, characterized in that, With the X-axis coaxial with the central axis of the tee pipe, the Y-axis orthogonal to the X-axis, and the Z-axis orthogonal to both the X-axis and the Y-axis defined, the Y-axis passes through the outlet; Within the XY plane defined by the X and Y axes, the width of the first fork is not less than the width of the second fork, the width of the first fork is the dimension along the Y-axis, and the width of the second fork is the dimension along the X-axis.
6. The interventional circulatory support system according to claim 5, characterized in that, The width of the first fork is 1.1 to 1.4 times the width of the second fork.
7. The interventional circulatory support system according to claim 5, characterized in that, Within the XY plane defined by the X and Y axes, the width of the exit is 1-3 times the width of the second fork.
8. The interventional circulatory support system according to claim 1, characterized in that, The inner surface of the three-way pipe has a first inner wall and a second inner wall, the outlet is disposed on the first inner wall, and the second inner wall faces the first inner wall; The flow guide includes a first flow guide and a second flow guide separated from each other. The first flow guide is disposed on the first inner wall and extends toward the side where the second inner wall is located. The second flow guide is disposed on the second inner wall and extends toward the side where the first inner wall is located. The gap between the first flow guide and the second flow guide forms the turning flow channel. A second contraction section is defined between the surface of the first flow guide on the side where the second inner wall is located and the second inner wall. A first contraction section is defined between the surface of the first flow guide on the side where the first inner wall is located and the first inner wall.
9. The interventional circulatory support system according to claim 8, characterized in that, A flow divider block is provided inside the turning channel, which divides the turning channel into two sub-channels. The two sub-channels are arranged at intervals along the width direction of the turning channel.
10. The interventional circulatory support system according to claim 9, characterized in that, One end of the diverting block passes through the second fork and extends toward the outlet. The diverting block protrudes from the end of the second guide near the outlet and does not exceed 30% of the width of the first fork.
11. The interventional circulatory support system according to claim 1, characterized in that, The cross-sections of the first channel and the second channel are circular, and the turning angle of the turning channel is 85°~90°.
12. The interventional circulatory support system according to claim 11, characterized in that, The flow guide includes a shell portion, which is disposed in the transition channel between the end of the turning flow channel and the outlet, and covers the area around the first fork.
13. The interventional circulatory support system according to claim 12, characterized in that, A flow divider is provided on one side of the casing facing the end of the turning channel. The flow divider is used to guide the fluid flowing out of the turning channel to move towards both circumferential sides of the casing.
14. The interventional circulatory support system according to claim 13, characterized in that, The sidewall of the casing portion extending obliquely toward the outlet direction on the side facing the turning channel, the diversion portion having a first inclined surface and a second inclined surface, the first inclined surface intersecting the second inclined surface, and the intersection line defining a diversion ridge, the diversion ridge extending obliquely from the radially outer sidewall of the turning channel toward the axial end face of the casing portion, the first inclined surface and the second inclined surface being located on opposite sides of the diversion ridge along the circumference of the casing portion.
15. The interventional circulatory support system according to claim 14, characterized in that, The extent by which the housing portion extends into the transition channel does not exceed half the width of the transition channel.