WO2023134693A1 - Dispositif de pompage de sang - Google Patents

Dispositif de pompage de sang Download PDF

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Publication number
WO2023134693A1
WO2023134693A1 PCT/CN2023/071709 CN2023071709W WO2023134693A1 WO 2023134693 A1 WO2023134693 A1 WO 2023134693A1 CN 2023071709 W CN2023071709 W CN 2023071709W WO 2023134693 A1 WO2023134693 A1 WO 2023134693A1
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WIPO (PCT)
Prior art keywords
blood
section
flexible tube
pump casing
pumping device
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PCT/CN2023/071709
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English (en)
Chinese (zh)
Inventor
唐智荣
赵贤忠
薛志宽
徐玲艳
Original Assignee
丰凯利医疗器械(上海)有限公司
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Publication of WO2023134693A1 publication Critical patent/WO2023134693A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices

Definitions

  • the embodiments of the present application belong to the technical field of cardiac assist devices, and in particular relate to a blood pumping device.
  • PCI Percutaneous coronary intervention
  • a percutaneously implantable artificial ventricular assist device is a miniaturized blood pumping device whose blood pumping performance is determined by the operating mode of the blood pump and does not depend on the patient's physical state. It is an active blood circulation support device.
  • the artificial ventricular assist device can be implanted through PCI surgery, which can provide patients with more stable blood circulation support during high-risk PCI surgery, improve coronary artery and distal organ perfusion while reducing the burden on the heart, and is conducive to the stability of the patient's signs during the operation. Postoperative recovery.
  • the core component of an artificial ventricular assist device is the pumping catheter.
  • Traditional pumping catheters generally include a suction channel, a transvalvular tube, and an outflow channel. Because the traditional transvalvular tube usually has a certain rigidity, it can play a stabilizing effect on the front part of the blood pumping catheter when the blood pumping catheter is inserted into the patient's body.
  • the transvalvular tube with certain rigidity will be located at the heart valve for a long time and be in contact with the heart valve for a long time, resulting in problems such as redness, swelling and functional damage of the heart valve. , causing damage to the human body.
  • the stroke between the suction channel and the outflow channel is long, which causes a loss of blood flow pumped into the blood vessel.
  • the present application aims to solve at least one of the technical problems existing in the related art.
  • the present application provides a blood pumping device, which has an ingenious structure, can effectively reduce damage to heart valves, and can effectively increase the delivery flow of blood.
  • the blood pumping device includes: a blood pumping assembly, including a pump casing configured as a rigid tube structure and an impeller rotatably arranged in the pump casing, the proximal peripheral surface and the distal peripheral surface of the pump casing There are at least one blood inlet and blood outlet respectively on the top; the flexible tube is configured as an elastic hose structure with an expandable and compressible outer wall, which is arranged on the pump casing and covers the blood outlet, and at least one outflow window is opened on the peripheral surface, The lumen of the flexible tube forms an outflow channel in communication with the blood outlet and outflow window.
  • a flexible tube is arranged on the pump casing, and the flexible tube is configured as an elastic hose structure with an expandable and compressible outer wall.
  • the flexible tube replaces the traditional rigid transom
  • the valve tube can effectively reduce the damage to the patient's heart valve by utilizing the flexibility of the flexible tube.
  • the flexible tube is ingeniously placed on the pump casing, and the expandable and compressible structural characteristics of the flexible tube are used to shorten the stroke of the blood flow and greatly increase the pumping distance without changing the impeller speed.
  • the blood flow in the blood vessel makes the flexible tube expand and compress synchronously under the opening and closing action of the heart valve, so that the whole blood pumping device produces a pulsating blood flow that matches the diastolic and compressible characteristics of the patient's heart Or pulsatile blood flow output, improving coronary artery and distal organ perfusion while reducing the burden on the heart, which is conducive to the stability of the patient's signs during the operation and postoperative recovery.
  • the pump casing as a rigid tube structure, the traditional rigid transvalvular tube is canceled, and the distance between the blood inlet and the blood outlet is shortened, so that blood can quickly flow into the flexible tube and then into the blood vessel.
  • the rigid pump casing not only supports and carries the flexible tube, but also enables the flexible tube to be stably filled and expanded by blood or compressed by the heart valve, avoiding irregular expansion or compressibility of the flexible tube due to uneven force. Deformation, to ensure the stability of the blood flow in it, and to ensure that the pump casing has no unacceptable deformation under certain pressure and bending force, and to ensure the structural stability of the pump casing and the impeller inside.
  • the shape of the flexible pipe is configured as follows: along its length direction, it is wide in the middle and narrow at both ends; or, along its length direction, it is wide at both ends and narrow in the middle.
  • the central axis of the pump housing coincides with the central axis of the flexible pipe, and the inner diameter of the flexible pipe is larger than the outer diameter of the pump housing.
  • the flexible pipe includes a transition section, a horizontal section, and a lead-out section that are smoothly connected in sequence.
  • the blood outlet faces the inner wall of the transition section
  • the outflow window is set on the side wall of the outlet section and is parallel to the horizontal section
  • the far end and the proximal end of the flexible tube are sealed and connected to the outer wall of the pump casing through the transition section and the outlet section respectively.
  • the transition section is smoothly connected to the horizontal section through an arc section, and the radius of the circle where the arc section is located is equal to the inner diameter of the horizontal section.
  • the flexible pipe includes a first straight segment, a second straight segment and a third straight segment connected smoothly in sequence, and the inner diameters of the first straight segment and the third straight segment are equal and larger than the second straight segment.
  • Inner diameter, the two ends of the second straight line segment are smoothly connected with the first straight line segment and the third straight line segment through two arc segments, and the two ends of the flexible pipe are respectively connected with the pump casing through the first straight line segment and the third straight line segment .
  • the pump casing is processed in one piece.
  • the pump casing is formed by detachably butting two sections of connecting pipe, wherein the outer wall of one connecting pipe is provided with multiple blood inlets along the circumferential direction, and the outer wall of the other connecting pipe is provided with multiple blood outlets along the circumferential direction, and the impeller It is rotatably passed between two sections of connecting pipes and is between the blood inlet and the blood outlet.
  • the blood pump assembly further includes a sheath tube, the sheath tube is passed through the outflow channel and connected to the proximal end of the pump casing, and the two ends of the flexible tube are respectively sealed with the outer wall of the pump casing and the outer wall of the sheath tube connect.
  • the blood pump assembly further includes a guide hose disposed at the distal end of the pump housing and a guide wire for passing through the guide hose, and the distal end of the guide wire can extend out of the guide hose
  • the proximal end of the guide wire can protrude from the proximal end of the guide hose or the blood inlet of the pump housing.
  • the blood pumping assembly further includes a rotating driving member disposed outside the body or disposed in the pump housing, and the output end of the rotating driving member is directly or indirectly connected to the impeller to drive the impeller to rotate around itself.
  • the pump casing is provided with a bearing seat, a rotating shaft and a transmission shaft, the rotating shaft is arranged in the bearing seat through a bearing, the impeller is suspended on the rotating shaft, and the far end of the driving shaft is close to the rotating shaft. end coaxial connection.
  • Fig. 1 is a schematic structural diagram of a blood pumping device according to some embodiments of the present application.
  • Fig. 2 is a second structural schematic diagram of a blood pumping device according to some embodiments of the present application.
  • Fig. 3 is a partial enlarged view of A place in Fig. 2;
  • Fig. 4 is a structural schematic diagram III of a blood pumping device according to some embodiments of the present application.
  • Fig. 5 is a schematic diagram of the structure of the blood pumping device in some embodiments of the present application after being inserted into the patient's body;
  • Fig. 6 is another schematic diagram of the structure of the blood pumping device in some embodiments of the present application after it is inserted into the patient's body;
  • Fig. 7 is a schematic diagram of the cooperative structure of the pump casing and the flexible pipe in some embodiments of the present application.
  • Fig. 8 is a schematic diagram of another cooperative structure of the pump casing and the flexible pipe in some embodiments of the present application.
  • Fig. 9 is a schematic structural view of a pump housing in some embodiments of the present application.
  • Fig. 10 is an exploded view of the pump casing of some embodiments of the present application.
  • Fig. 11 is a fourth structural schematic diagram of a blood pumping device according to some embodiments of the present application.
  • Fig. 12 is a fifth structural schematic diagram of a blood pumping device according to some embodiments of the present application.
  • pump casing 100 blood inlet 110; blood outlet 120; connecting pipe 130; bearing seat 140; rotating shaft 150; transmission shaft 160; bearing 170; Horizontal section 330; arc section 331; transition section 340; lead-out section 350; first straight section 360; second straight section 370; third straight section 380; arc section 390; sheath tube 400; guiding hose 500; The curved part 510 ; the guide wire 600 ; the ventricle 700 ; the blood vessel 800 ; the heart valve 900 ; the inner diameter D1 of the first straight section;
  • orientation descriptions such as up, down, front, back, left, right, etc. indicated orientations or positional relationships are based on the orientations or positional relationships shown in the drawings, and are only For the convenience of describing the embodiment of the present application and simplifying the description, it does not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the embodiment of the present application.
  • in vivo means inside the tissues and organs of the patient
  • in vitro means outside the tissues and organs of the patient.
  • distal refers to a direction away from the physician
  • proximal refers to a direction close to the physician.
  • aortic valve located between the left ventricle and the aorta opens, and the blood in the left ventricle flows into the aorta under systolic pressure, so that the aorta
  • the arteries transfuse blood into the tissues and organs of the human body; at the same time, the pulmonary valve between the right ventricle and the pulmonary artery opens, and the blood in the right ventricle flows into the pulmonary artery, so that the pulmonary artery can transfuse blood to the pulmonary vein and branch organs of the human body.
  • the aortic valve closes to prevent blood in the aorta from flowing back into the left ventricle; at the same time, the pulmonary valve closes to prevent blood in the pulmonary artery from flowing back into the right ventricle.
  • the aorta of the human body is divided into ascending aorta, aortic arch and descending aorta sequentially along the direction of blood flow, and the ascending aorta, aortic arch and descending aorta are connected in turn.
  • the etiology of coronary heart disease or other cardiovascular diseases mainly reflects that blood cannot flow to the myocardium or brain in time, resulting in hypoxia and necrosis of organs and tissues.
  • the blood pumping device of the present application can provide stable blood circulation support for the patient's heart, and can reduce the damage to the patient's heart valve. At the same time, compared with the traditional blood pumping catheter, it reduces the loss of blood flow and improves
  • the perfusion of coronary arteries and remote organs can be reduced while reducing the burden on the heart, which is conducive to the stability of the patient's signs during the operation and postoperative recovery.
  • the present application discloses a blood pumping device, which includes a blood pumping assembly and a flexible tube 300 .
  • the blood pump assembly includes a pump casing 100 configured as a rigid tube structure and an impeller 200 rotatably arranged in the pump casing 100, and at least one blood vessel is provided on the proximal peripheral surface and the distal peripheral surface of the pump casing 100 respectively.
  • inlet 110 and blood outlet 120 .
  • the flexible tube 300 is configured as an elastic hose structure with an expandable and compressible outer wall.
  • the flexible tube 300 is arranged on the pump casing 100 and covers the blood outlet 120.
  • At least one outflow window 320 is opened on the peripheral surface of the flexible tube 300.
  • the flexible tube 300 The cavity forms an outflow channel 310 communicating with the blood outlet 120 and the outflow window 320 .
  • the shape of the flexible pipe 300 is configured to be: wide in the middle and narrow at both ends along its length direction; or, wide at both ends and narrow in the middle along its length direction.
  • the cavity of the pump casing 100 communicates with the blood inlet 110 and the blood outlet 120 for blood circulation.
  • the pump casing 100 is a rigid structure to ensure the structural stability of the pump casing 100 and the impeller 200 disposed therein, and at the same time play a role of supporting and carrying the flexible pipe 300 .
  • the pump casing 100 can be made of stainless steel, PEEK, POM and other materials with mechanical strength and high density, so as to ensure that the pump casing 100 has no unacceptable deformation under certain pressure and bending force, and ensure that the pump casing 100 and the impeller 200 inside are structural stability.
  • the flexible tube of the blood pumping device 300 expands and compresses synchronously when the heart valve opens and closes.
  • the volume of the flexible tube 300 continues to expand and increase.
  • the flexible tube 300 expands to the maximum state, the flexible tube 300 is in a filling state, and the caliber of the outflow window 320 set on the flexible tube 300 expands to the maximum simultaneously.
  • the blood flow out of the window 320 reaches the maximum value, and the blood flow delivered by the whole blood pumping device is greatly increased without changing the rotation speed of the impeller 200 .
  • the flexible tube 300 can be designed as a soft film made of TPU, silica gel, PEBAX or other polymer materials.
  • the flexible tube 300 When the blood pumping device of the present application is inserted into the patient's body, the flexible tube 300 is in a compressed state, so that the pump When the blood device is inserted into the patient's body, the area of the surgical wound is minimized.
  • the whole blood pump device works, and blood continuously flows into the outflow channel 310 formed by the cavity of the flexible tube 300.
  • the volume of the tube 300 expands and increases, and the outflow channel 310 remains expanded after being filled with blood.
  • the shape of the flexible tube 300 can be an olive-shaped structure, and its inner and outer walls are arc-shaped, so that the connection between the flexible tube 300 and the pump housing 100 has a circular arc transition, so that blood can smoothly flow into the cavity of the flexible tube 300 from the blood outlet 120
  • the formed outflow channel 310 The overall outline of the flexible tube 300 is streamlined, which reduces the resistance of blood flowing in the outflow channel 310, ensures the smooth flow of blood along the blood outlet 120, the outflow channel 310 and the outflow window 320, and reduces the flow of blood into the outflow channel 310 and the flow of blood in the outflow channel 310.
  • the impact on the flexible tube 300 during the flow of the channel 310 prevents the blood from colliding with the inner wall of the flexible tube 300 as much as possible, and reduces the probability of mechanical hemolysis of the blood.
  • the doctor can insert the blood pumping device into the patient's body through percutaneous surgery, so that the pump housing 100 and the flexible tube 300 arranged on it can cross the heart valve 900 synchronously, and make the pump housing 100 100 is partly or completely located in the patient's ventricle 700, so that the blood inlet 110 on the pump casing 100 communicates with the ventricle 700, and at the same time, the flexible tube 300 is placed between the ventricle 700 and the blood vessel 800 communicating with the ventricle 700 across the heart valve 900 , so that the outflow window 320 on the flexible tube 300 communicates with the blood vessel 800 , and the patient's heart valve 900 only contacts the outer wall of the flexible tube 300 .
  • the impeller 200 rotates, and the blood in the ventricle 700 continuously enters the cavity of the pump casing 100 from the blood inlet 110 under the power of the impeller 200, and then flows into the cavity of the flexible tube 300 through the blood outlet 120 to form a outflow channel 310, and finally flow into blood vessel 800 from outflow window 320, thereby completing the delivery of blood.
  • the volume of the flexible tube 300 continues to expand and increase.
  • the volume of the flexible tube 300 expands to the maximum state, the flexible tube 300 is in a filling state, and the caliber of the outflow window 320 set on the flexible tube 300 is simultaneously expanded to the maximum.
  • the flow reaches the maximum value, and the blood flow delivered to the blood vessel 800 by the entire blood pumping device is greatly increased without changing the rotation speed of the impeller 200 .
  • the leaflets of the heart valve 900 are aligned with each other, thereby extruding the outer wall of the flexible tube 300, so that the flexible tube 300 shrinks along the line of alignment of the leaflets, thereby greatly reducing the diameter of the outflow channel 310 or even completely Close the outflow channel 310 so that blood cannot flow into the blood vessel 800; when the heart valve 900 is opened, the flexible tube 300 expands to the maximum state under the pressure of the blood, and the blood flow flows into the blood vessel 800 again at the maximum flow rate.
  • the flexible tube 300 expands and contracts synchronously, thereby generating pulsatile blood flow or pulsatile blood flow output that matches the diastolic and systolic characteristics of the patient's heart, improving coronary and It reduces the burden on the heart while improving the perfusion of the distal organs, which is conducive to the stability of the patient's signs during the operation and postoperative recovery.
  • the ventricle 700 may correspond to the patient's left ventricle or right ventricle
  • the blood vessel 800 corresponds to the aorta communicating with the left ventricle or the pulmonary artery communicating with the right ventricle
  • the corresponding heart valve 900 corresponds to the aortic valve between the left ventricle and the aorta or the pulmonary valve between the right ventricle and the pulmonary artery.
  • the application scenarios of the blood pumping device of the present application are not limited to the above-mentioned left ventricle, aorta, right ventricle 700 and pulmonary artery, and can also be applied to other tissues and organs of the human body to assist in pumping blood.
  • the flexible pipe 300 can also be in the shape of a narrow middle and wide ends.
  • the shape of the flexible pipe 300 can be similar to a barbell, and the inner diameter of the narrow middle part of the flexible pipe 300 is larger than that of the pump casing. 100 inner diameter.
  • the heart valve 900 straddles between the ventricle 700 and the blood vessel 800 , so that the leaflets of the heart valve 900 only touch the narrow part in the middle of the flexible tube 300 , while the wide part at the proximal end of the flexible tube 30 is entirely inside the blood vessel 800 .
  • the force of the heart valve 900 squeezing the outer wall of the flexible tube 300 can be reduced during the process of the heart valve 900 squeezing the flexible tube 300 to make it shrink, and correspondingly, the flexible tube 300 can be reduced. Reaction force on heart valve 900 .
  • the outer wall of the heart valve 900 and the flexible tube 300 will be squeezed against each other for a long time.
  • the flexible tube 300 By designing the flexible tube 300 into the above-mentioned shape and shortening the inner diameter of the middle part of the flexible tube 300, the blood flow is basically not affected.
  • the damage to the heart valve 900 caused by the outer wall of the flexible tube 300 can be effectively reduced.
  • the flexible tube 300 is arranged on the pump casing 100, and the flexible tube 300 is configured as an elastic hose structure with an expandable and compressible outer wall.
  • the flexible tube 300 replaces the The traditional rigid transvalvular tube can effectively reduce damage to the patient's heart valve 900 by utilizing the flexibility of the flexible tube 300 .
  • the flexible tube 300 is ingeniously placed on the pump casing 100, and the expandable and compressible structural characteristics of the flexible tube 300 are used to shorten the stroke of the blood flow and greatly increase the It not only ensures the blood flow pumped into the blood vessel 800, but also makes the flexible tube 300 expand and contract synchronously under the opening and closing action of the heart valve 900, so that the whole blood pumping device can adapt to the diastolic and systolic characteristics of the patient's heart.
  • the pulsatile blood flow or pulsatile blood flow output can improve the perfusion of coronary arteries and remote organs while reducing the burden on the heart, which is beneficial to the stability of the patient's signs during the operation and postoperative recovery.
  • the flexible tube 300 is in an initial compressed state before being inserted into the patient's body.
  • the lower flexible tube 300 is inserted into the position of the patient's heart valve 900 through percutaneous surgery, which can minimize the surgical wound area and at the same time increase the pumping blood flow rate of the entire blood pumping device under the same surgical wound area.
  • the rigid pump casing 100 not only supports and carries the flexible tube 300, but also enables the flexible tube 300 to be stably filled and expanded by blood or compressed by the heart valve 900, avoiding irregularities in the flexible tube 300 due to uneven force.
  • the expansion or contraction deformation ensures the stability of the blood flow in it, and ensures that the pump casing 100 has no unacceptable deformation under certain pressure and bending force, and ensures the structural stability of the pump casing 100 and the impeller inside. .
  • the central axis of the pump casing 100 coincides with the centerline axis of the flexible pipe 300, and the inner diameter of the flexible pipe 300 is greater than the outer diameter of the pump casing 100 , it is not difficult to understand that the flexible tube 300 has a symmetrical structure with respect to the central axis of the pump housing 100 or the extension line of the central axis, so that the volume of the flexible tube 300 will be expanded evenly after the blood flows into the outflow channel 310 from the blood outlet 120, and then the volume of the flexible tube 300 will be evenly expanded.
  • the flexible tube includes a transition section 340, a horizontal section 330, and a lead-out section 350 that are smoothly connected in sequence.
  • the inner diameter of the transition section 340 gradually increases from the distal end to the proximal end, and the lead-out section 350
  • the inner diameter of the flexible tube gradually decreases from the far end to the proximal end, the blood outlet faces the inner wall of the transition section 340, the outflow window is opened on the side wall of the outlet section 350 and is parallel to the horizontal section 330, the distal end and the proximal end of the flexible tube respectively pass through the transition section 340 and the outlet section 350 are sealingly connected to the outer wall of the pump casing.
  • the inner diameter of the horizontal section 330 is larger than the inner diameter of the transition section 340 and the lead-out section 350, and the transition section 340 and the lead-out section 350 are mirror-symmetrical to the horizontal section 330, and the flexible pipe 300 is composed of the transition section 340, the horizontal section 330 and the lead-out section. Section 350 is integrally formed.
  • a plurality of blood outlets 120 are evenly and spaced on the distal peripheral surface of the pump casing 100, and the port of the transition section 340 is connected to the outer wall of the pump casing 100 in an annular seal, so that the blood outlets 120 All are inside the transition section 340 to ensure that the blood flows into the transition section 340 evenly.
  • the sidewall of the outlet section 350 is uniformly and spaced apart from a plurality of outflow windows 320 .
  • the blood when blood flows into the outflow channel 310 from the blood outlet 120 , since the blood outlet 120 faces the inner wall of the transition section 340 , the blood first contacts the inner wall of the transition section 340 and flows along the inner wall of the transition section 340 to the horizontal section 330 . Since the inner diameter of the transition section 340 gradually increases from the distal end to the proximal end, the flow velocity of the blood flowing along the transition section 340 will gradually decrease. During this time, the kinetic energy of the blood flow hitting the inner wall of the flexible tube 300 is minimized, thereby reducing the probability of mechanical hemolysis caused by the blood flow.
  • the flow velocity of the blood flowing along the outlet section 350 will gradually increase.
  • the blood flow velocity basically reaches the maximum, so that the blood flows into the blood vessel from the outflow window 320 at this blood flow velocity, so as to accelerate the speed of blood flowing into the blood vessel.
  • the outflow window 320 on the lead-out section 350 is set to be parallel to the horizontal section 330, it is ensured that the blood flowing out from the outflow window 320 flows along the axis of the blood vessel 800 at a relatively high flow rate, and the blood flow into the blood vessel 800 is ensured. At the same time, it can avoid the blood flow flowing out of the outflow window 320 from hitting the wall of the blood vessel 800 and impacting the wall of the blood vessel 800, and also avoid the vortex flow caused by the change of the flow direction of the blood flow out of the outflow window 320, preventing The generation of irregular blood flow avoids adverse effects on patients.
  • the transition section 340 is an inclined plane or an arc surface with a curvature close to zero, and the ratio between the outer diameter of the horizontal section 330 and the minimum outer diameter at the port of the transition section 340 is greater than 1. and be less than or equal to 3, the optimum ratio is 5/3; meanwhile, the angle between the main boundary of the transition section 340 and the central axis of the horizontal section 330 is greater than or equal to 45° and less than 90°, the optimum angle is 60° °.
  • the probability of mechanical hemolysis of the blood flowing from the blood outlet 120 into the outflow channel 310 Minimum that is, under the above conditions, the kinetic energy of the blood flow impacting the flexible tube 300 can be reduced to the minimum, the probability of mechanical hemolysis of the blood flow can be reduced to the greatest extent, and the possibility of other diseases caused by mechanical hemolysis to the patient can be eliminated as much as possible. risk.
  • the transition section 340 is smoothly connected to the horizontal section 330 through the arc section 331 , and through the design of the arc section 331 , the blood flow in the transition section 340 can smoothly flow into the horizontal section 330 , to realize the smooth transition of blood flow from oblique flow to horizontal flow.
  • the smooth transition effect of the blood flow is the best, further reducing the risk of mechanical hemolysis of the blood flow during the above flow process probability.
  • the lead-out section 350 is also smoothly connected to the horizontal section 330 through an arc section to ensure a smooth transition of blood flow from the horizontal section 330 to the lead-out section 350 .
  • the blood pumping assembly in order to ensure the structural stability of the flexible tube 300 in a compressed state before being filled with blood and in an expanded state after being filled with blood, the blood pumping assembly further includes a sheath 400 ,
  • the sheath tube 400 is penetrated in the outflow channel 310 and connected to the proximal end of the pump casing 100, and the two ends of the flexible tube 300 are respectively sealed and connected to the outer wall of the pump casing 100 and the outer wall of the sheath tube 400.
  • the distal end of the transition section 340 and the proximal end of the horizontal section 330 are respectively sealed and connected to the outer wall of the pump casing 100 and the outer wall of the sheath tube 400.
  • the pump casing 100 and the sheath tube 400 together play a role in supporting and maintaining the flexible tube 300.
  • the load-bearing function enables the flexible tube 300 to be stably filled and expanded by blood or compressed by the heart valve 900, avoiding irregular expansion or contraction deformation of the flexible tube 300 due to uneven force, and ensuring the stability of blood flow in it.
  • the flexible pipe 300 includes a first straight line segment 360 , a second straight line segment 370 and a third straight line segment 380 connected smoothly in sequence, wherein the first straight line segment 360 and the third straight line segment 360
  • the inner diameters of the segments 380 are equal and larger than the inner diameter of the second straight segment 370
  • both ends of the second straight segment 370 are smoothly connected to the first straight segment 360 and the third straight segment 380 through two arc segments 390 .
  • the flexible tube 300 is inserted between the ventricle 700 and the blood vessel 800 communicating with the ventricle 700, so that the first straight line segment 360 is fully extended into the ventricle.
  • the second straight section 370 just crosses the heart valve 900 between the ventricle 700 and the blood vessel 800, so that the leaflets of the heart valve 900 only touch the outer wall of the second straight section 370, while the third straight section 380 is entirely in the blood vessel.
  • the ratio of the inner diameter D1 of the first straight segment 360 to the inner diameter D2 of the second straight segment 370 is between 0.6 and 0.9, and the optimal value is 0.85; the length of the second straight segment 370 is between 6 mm and 10 mm Between; the arc segment 390 is tangent to the first straight segment 360 and the second straight segment 370 respectively.
  • the arc segment 390 is formed by the smooth connection of two arc segments. Among the tangents on 390, the angle between the tangent with the largest slope and the central axis of the first straight line segment 360 ranges from 30° to 60°, and the best value is 42°.
  • the radius length of the circle where the arc segment tangent to the first straight line segment 360 is between 5 mm and 10 mm, the optimal value is 8 mm, and the arc segment tangent to the second straight line segment 370 is located
  • the radius length of the circle is also between 5mm and 10mm, and the optimum value is 6mm.
  • Table 1 shows the best embodiment of the flexible tube shown in Figure 7 and the flexible tube shown in Figure 8 under the same pressure difference between the blood inlet 110 and the blood outlet 120 of the blood pumping device of the present application.
  • the simulation test data comparison chart of the blood flow pumped into the blood vessel :
  • the shape and size of the second straight line segment 370 and the third straight line segment 380 meet the following conditions:
  • the ratio of the inner diameter D1 of the first straight line segment 360 to the inner diameter D2 of the second straight line segment 370 is 0.85, the length of the second straight line segment 370 is between 6 mm and 10 mm, and among the tangent lines on the arc segment 390, the tangent line with the largest slope is the same as the first straight line segment.
  • the value of the included angle between the central axes of the straight line segment 360 is 42°, and the value of the radius length of the circle where the arc segment tangent to the first straight line segment 360 is in the arc segment at both ends of the arc segment 390 is 8 mm, the radius of the circle where the arc segment tangent to the second straight segment 370 is 6 mm, and the shape and size parameters of the first straight segment 360 and the third straight segment 380 are the same.
  • the extrusion damage of the outer wall of the flexible tube 300 to the heart valve 900 is not only minimal, but compared with the flexible tube shown in FIG.
  • the range of the flow rate pumped by the blood pumping device into the blood vessel 800 is only 0.09 L/min to 0.2 L/min, which is basically negligible.
  • the pump housing 100 is formed by detachably butting two sections of connecting pipe 130, wherein the outer wall of one section of connecting pipe 130 is provided with a plurality of blood inlets 110 along the circumference, and the other section is connected to
  • the outer wall of the tube 130 is provided with a plurality of blood outlets 120 along the circumference, and the impeller 200 is rotatably passed between the two connecting tubes 130 and between the blood inlet 110 and the blood outlet 120 .
  • the two sections of the connecting pipe 130 can be connected as a whole by gluing or welding.
  • the two sections of connecting pipe 130 can be disassembled first, and then the impeller 200 can be accurately installed into one of the connecting pipes 130, so that the center of the impeller 200 The axis coincides with the central axis of the connecting pipe 130, and then another section of connecting pipe 130 is docked, so that the entire tubular pump casing 100 is coaxial with the impeller 200, ensuring the installation accuracy of the impeller 200, thereby allowing the blood to circulate evenly, further reducing the Probability of small flow mechanical hemolysis.
  • the pump housing 100 can be processed in one piece. On the one hand, it can reduce the number of parts and reduce the complexity of the process. safety and stability.
  • the blood pump assembly further includes a guide hose 500 disposed at the distal end of the pump casing 100 and a guide wire 600 for passing through the guide hose 500 , the distal end of the guide wire 600 can protrude from the distal end of the guide tube 500 , and the proximal end of the guide wire 600 can protrude from the proximal end of the guide tube 500 or the blood inlet 110 of the pump housing 100 .
  • the blood pumping device of the present application needs to enter the corresponding blood transfusion organ or blood vessel 800 through percutaneous surgery.
  • Fig. 5, Fig. 6, Fig. 11 and Fig. 12 taking the left ventricle and the aorta connected with the left ventricle as an example, when the blood pumping device enters the left ventricle along the aorta, it needs to go through the Epidermal notch, aortic vessel, aortic arch and across the aortic valve.
  • the operator can pre-insert the guide wire 600 into the left ventricle 700 according to a predetermined path, and make the guide wire 600 extend along the path of the aorta so that its proximal end protrudes out of the body, and then insert the device
  • the guide hose 500 at the distal end of the pump casing 100 is sleeved on the proximal end of the guide wire 600 and enters into the left ventricle along the track of the guide wire 600, so that the guide hose 500 can be guided by the guide wire 600 , drive the pump casing 100 and the flexible tube 300 on the pump casing 100 to the corresponding positions of the left ventricle and aorta, at this time, the proximal end of the guide wire 600 protrudes from the proximal end of the guiding tube 500, and this is completed Precise intervention of the entire blood pumping device.
  • the guide hose 500 communicates with the blood inlet 110 on the pump housing 100 , and the operating physician pre-inserts the guide wire 600 into the left ventricle according to a predetermined path, and makes the guide wire 600 along the main
  • the guiding hose 500 set at the distal end of the pump casing 100 is sleeved on the proximal end of the guide wire 600 and enters the left ventricle along the track of the guide wire 600 700, so that the guide hose 500 can drive the pump housing 100 and the flexible tube 300 on the pump housing 100 to the left ventricle and the corresponding position of the aorta under the guidance of the guide wire 600.
  • the guide wire 600 The proximal end passes through the guide hose 500 and the blood inlet 110 on the pump housing 100 and protrudes from the blood inlet 110, thus completing the precise intervention of the whole blood pumping device.
  • the guide wire 600 has a longer travel path in the blood pumping device, which increases the stability of the entire blood pump device along the guide wire 600 , which facilitates the operation of the doctor and improves the efficiency of the doctor's percutaneous surgery.
  • the setting of the guide wire 600 and the guiding hose 500 in this application not only facilitates the doctor to quickly insert the entire blood pumping device into the corresponding blood transfusion organ, but also improves the accuracy of the entire blood pumping device being inserted into the corresponding blood transfusion organ. To a certain extent, the damage to the patient is reduced.
  • the distal end of the guide tube 500 also has a preformed bend 510.
  • the distal end of the curved part 510 is sleeved on the guide wire 600, and made to extend along the guide wire 600 in a straight line, and then the entire guide hose 500, the pump casing 100 and the flexible tube 300 on the pump casing 100 are driven to the corresponding positions of the left ventricle 700 and the aorta, and then the physician withdraws the guide wire 600, and the curved portion 510 restores the original memory shape again, preferably, the curved portion 510 is in the shape of a pig's tail.
  • the curved profile of the curved portion 510 it is beneficial for the blood in the ventricle 700 to flow into the blood inlet 110 along the trajectory of the curved portion 510, and then flow into the blood vessel 800.
  • the setting of the curved portion 510 plays a role in drainage, facilitating the flow of blood
  • the impeller 200 quickly flows into the blood vessel 800 .
  • the blood pump assembly further includes a rotary drive member (not shown in the figure) arranged outside the body or in the pump housing 100, the output end of the rotary drive member
  • the impeller 200 is directly or indirectly connected to drive the impeller 200 to rotate around itself.
  • the pump casing 100 is provided with a bearing seat 140, a rotating shaft 150 and a transmission shaft 160, the rotating shaft 150 is arranged in the bearing seat 140 through a bearing 170, and the impeller 200 is suspended on the rotating shaft 150.
  • the distal end of the transmission shaft 160 is coaxially connected to the proximal end of the rotating shaft 150, and the proximal end of the transmission shaft 160 is connected to a rotating drive member.
  • the rotating drive member can be a power component such as a motor or a motor, and its specific structure is not limited.
  • the rotating drive member drives the transmission shaft 160 and the rotating shaft 150 to rotate, and then drives the impeller 200 to rotate, so as to output the blood pumping driving force for the whole blood pumping device.
  • the impeller 200 is suspended on the rotating shaft 150, that is, the proximal end of the impeller 200 is connected to the rotating shaft 150, and the distal end is a free end.
  • the impeller adopts a support structure at both ends, that is, both the far end and the proximal end of the impeller are provided with a support structure, for the support structure at the far end of the impeller, the wear particles generated during operation cannot be recovered outside the body, but can only enter the body, which is easy to produce Adverse reactions affect the safety of the product.
  • the rotating shaft 150 is set in the bearing seat 140 through the bearing 170, and the bearing 170 can be selected as two ball bearings, which is beneficial to realize the perfusate carrying particles back to the body by using the gap between the ball bearings itself.
  • the pump casing 100 of this embodiment is set as a rigid pipe structure, which can provide sufficient support for the impeller 200 of the cantilever structure, and achieve the purpose of large product flow and zero particles.
  • the middle part of the flexible tube 300 is pierced with a sheath tube 400 , and one end of the sheath tube 400 is in sealing connection with the proximal end of the pump housing 100 , the other end of the sheath tube 400 protrudes from the flexible tube 300 and extends outside the body along the path of the blood vessel 800 , the drive shaft 160 is penetrated in the sheath tube 400 and extends outside the body to be connected with the rotating driver, through the setting of the sheath tube 400 , to prevent the direct contact between the transmission shaft 160 and the blood in the blood vessel 800 to affect the physiological function of the blood, and at the same time, the sheath tube 400 also supports and carries the flexible tube 300 to ensure the structural stability of the flexible tube 300 .
  • the sheath tube 400 is a flexible and bendable structure, which will not cause structural damage to the corresponding blood vessel 800 or blood transfusion organ, and can well adapt to the curved or coiled shape of the corresponding blood pipeline.
  • the transmission shaft 160 can be a transmission skein, so as to adapt to the curved shape of the sheath tube 400 after being inserted into the body, while ensuring its transmission performance.
  • the sheath tube 400 is provided with a perfusion inlet pipeline and a perfusion outlet pipeline, so that all the particles generated during the operation of the impeller supported by the cantilever can be returned to the outside of the body.
  • the rotary drive member is directly arranged in the pump casing 100, and the output end of the rotary drive member is directly connected to the impeller 200 to directly drive the impeller to rotate.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un dispositif de pompage de sang. Le dispositif de pompage de sang comprend : un ensemble de pompage de sang, qui comprend un boîtier de pompe (100) configuré sous la forme d'une structure de tube rigide et une turbine (200) agencée de manière rotative dans le boîtier de pompe (100), au moins une entrée de sang (110) et une sortie de sang (120) étant respectivement disposées sur une surface périphérique proximale et une surface périphérique distale du boîtier de pompe (100) ; et un tube flexible (300), qui est configuré sous la forme d'une structure de tuyau élastique dont la paroi externe peut être étendue et contractée, est agencé sur le boîtier de pompe (100) et recouvre la sortie de sang (120), au moins une fenêtre de sortie (320) étant disposée sur une surface périphérique, une cavité du tube flexible (300) formant un canal de sortie (310) qui est en communication avec la sortie de sang (120) et la fenêtre de sortie (320), et la forme du tube flexible (300) étant configurée pour être : large au milieu et étroite aux deux extrémités dans sa propre direction longitudinale ; ou, large aux deux extrémités et étroite au milieu dans sa propre direction longitudinale.
PCT/CN2023/071709 2022-01-11 2023-01-10 Dispositif de pompage de sang WO2023134693A1 (fr)

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CN114259645A (zh) * 2022-01-11 2022-04-01 丰凯利医疗器械(上海)有限公司 泵血装置
WO2024037203A1 (fr) * 2022-08-18 2024-02-22 航天泰心科技有限公司 Pompe d'assistance circulatoire interventionnelle
CN116059525A (zh) * 2022-12-09 2023-05-05 深圳核心医疗科技有限公司 血泵和心室辅助系统

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