WO2023134693A1

WO2023134693A1 - Blood pumping device

Info

Publication number: WO2023134693A1
Application number: PCT/CN2023/071709
Authority: WO
Inventors: 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
Priority date: 2022-01-11
Filing date: 2023-01-10
Publication date: 2023-07-20
Also published as: CN114259645A

Abstract

A blood pumping device. The blood pumping device comprises: a blood pumping assembly, which comprises a pump casing (100) configured as a rigid tube structure and an impeller (200) rotatably arranged in the pump casing (100), wherein at least one blood inlet (110) and a blood outlet (120) are respectively provided on a proximal peripheral surface and a distal peripheral surface of the pump casing (100); and a flexible tube (300), which is configured as an elastic hose structure whose outer wall can be expanded and contracted, is arranged on the pump casing (100) and covers the blood outlet (120), wherein at least one outflow window (320) is provided on a peripheral surface, a cavity of the flexible tube (300) forms an outflow channel (310) which is in communication with the blood outlet (120) and the outflow window (320), and the shape of the flexible tube (300) is configured to be: wide in the middle and narrow at both ends in its own lengthwise direction; or, wide at both ends and narrow in the middle in its own lengthwise direction.

Description

blood pump

Cross References to Related Applications

This application claims priority to Chinese patent application 202210028952.9 filed on January 11, 2022, entitled "Blood Pumping Device", the entire content of which is incorporated herein by reference.

technical field

The embodiments of the present application belong to the technical field of cardiac assist devices, and in particular relate to a blood pumping device.

Background technique

Percutaneous coronary intervention (PCI) is a common and effective method for the treatment of coronary heart disease. Compared with heart bypass surgery, PCI surgery has lower risk, less trauma, less difficult operation and faster postoperative recovery. In addition, PCI surgery is also applicable to the rescue of acute myocardial infarction, and restores the patient's myocardial state by quickly restoring the blood perfusion of blocked blood vessels.

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. However, during the operation, due to the long operation time, 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. In addition, due to the presence of the transvalvular tube, the stroke between the suction channel and the outflow channel is long, which causes a loss of blood flow pumped into the blood vessel.

Contents of the invention

The present application aims to solve at least one of the technical problems existing in the related art. To this end, 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 according to an embodiment of the present application 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.

According to the blood pumping device of the present application, it has at least the following beneficial effects:

In the blood pumping device of the present application, 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. Compared with the traditional blood pumping catheter, 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. At the same time, 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, and 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. In addition, by setting 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. At the same time, 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.

According to some embodiments of the present application, 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.

According to some embodiments of the present application, 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.

According to some embodiments of the present application, the flexible pipe includes a transition section, a horizontal section, and a lead-out section that are smoothly connected in sequence. Small, 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.

According to some embodiments of the present application, 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.

According to some embodiments of the present application, 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 .

According to some embodiments of the present application, the pump casing is processed in one piece.

According to some embodiments of the present application, 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.

According to some embodiments of the present application, 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.

According to some embodiments of the present application, 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.

According to some embodiments of the present application, 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.

According to some embodiments of the present application, 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.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the accompanying drawings that need to be used in the embodiments of the present application. Obviously, the accompanying drawings described below are only some embodiments of the present application. Those of ordinary skill in the art can also obtain other drawings based on these drawings without making creative efforts.

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.

In the drawings: 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;

Detailed ways

Features and exemplary embodiments of various aspects of the present application will be described in detail below. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the application. It will be apparent, however, to one skilled in the art that embodiments of the present application may be practiced without some of these specific details. The following description of the embodiments is only to provide a better understanding of the present application by showing examples of the present application.

In the description of the present application, it should be understood that the 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 the description of the embodiments of the present application, several means one or more, and multiple means two or more. Greater than, less than, exceeding, etc. are understood as not including the original number, and above, below, within, etc. are understood as Include this number. If the description of the first and second is only for the purpose of distinguishing the technical features, it cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features relation.

In the description of the embodiments of the present application, unless otherwise clearly defined, words such as setting, installation, and connection should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the above words in this application in combination with the specific content of the technical solution .

It should be noted that, in the case of no conflict, the embodiments in the present application and the features in the embodiments can be combined with each other. The embodiments will be described in detail below in conjunction with the accompanying drawings.

In addition, it should be noted that, in the description of the embodiments of the present application, unless otherwise clearly defined, "in vivo" means inside the tissues and organs of the patient, and "in vitro" means outside the tissues and organs of the patient. Meanwhile, in the embodiments of the present application, "distal" refers to a direction away from the physician, and "proximal" refers to a direction close to the physician.

It should be noted that in a normal human heart, during a beating cycle, when the heart contracts, the 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. When the heart relaxes, 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.

Referring to FIG. 1 , FIG. 2 , FIG. 3 and FIG. 4 , the present application discloses a blood pumping device, which includes a blood pumping assembly and a flexible tube 300 .

Wherein, 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 .

Moreover, 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.

It should be understood that 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. When the whole blood pumping device is running, the flexible tube of the blood pumping device 300 expands and compresses synchronously when the heart valve opens and closes. After the blood continuously enters the outflow channel 310, the volume of the flexible tube 300 continues to expand and increase. When 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 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 . Specifically, the flexible tube 300 can be designed as a soft film made of TPU, silica gel, PEBAX or other polymer materials. 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. When the blood pump device is inserted into the patient's body, 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.

Specifically, 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.

Referring to Fig. 5 and Fig. 6, wherein, in Fig. 5, the patient's heart valve is in an open state; in Fig. 6, the patient's heart valve is in a closed state.

When the blood pumping device of the embodiment of the present application is applied, 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 .

When the whole blood pumping device is running, 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.

During the above-mentioned blood transportation process, thanks to the structural characteristics of the flexible tube 300 as an elastic tube, after the blood continuously enters the outflow channel 310, the volume of the flexible tube 300 continues to expand and increase. When 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 .

When the heart valve 900 is closed, 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. As the patient's heart valve 900 continues to open and close, 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.

It should be noted that, in the above description, the ventricle 700 may correspond to the patient's left ventricle or right ventricle, and correspondingly, the blood vessel 800 corresponds to the aorta communicating with the left ventricle or the pulmonary artery communicating with the right ventricle, and 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. Of course, 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.

In addition, it should be noted that the flexible pipe 300 can also be in the shape of a narrow middle and wide ends. Specifically, 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. When the blood pumping device is inserted into the patient's body, the flexible tube 300 is inserted between the ventricle 700 and the blood vessel 800 communicating with the ventricle 700, so that the wide part of the distal end of the flexible tube 300 is fully extended into the ventricle 700, and the narrow part in the middle is just right. 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 . Through the above design, when the heart valve 900 is closed, 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 . Considering that the operation time is long, the outer wall of the heart valve 900 and the flexible tube 300 will be squeezed against each other for a long time. 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. On the premise, the damage to the heart valve 900 caused by the outer wall of the flexible tube 300 can be effectively reduced.

In the blood pumping device of the present application, 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. Compared with the traditional blood pumping catheter, 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 .

At the same time, 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.

Moreover, using the expandable and compressible structural characteristics of the flexible tube 300, 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.

In addition, by setting the pump casing 100 into a rigid tube structure, the traditional rigid transvalvular tube is canceled, and the distance between the blood inlet 110 and the blood outlet 120 is shortened, so that blood can quickly flow into the flexible tube 300 and then into the blood vessel middle. At the same time, 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. .

Referring again to Fig. 1, Fig. 2, Fig. 3 and Fig. 4, in some embodiments of the present application, 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. Increase the volume of the outflow channel 310, and at the same time, effectively improve the flow of blood flowing into the blood vessel 800, and at the same time ensure the linearity of the blood flowing in the outflow channel 310, and further prevent the blood from colliding with the inner wall of the flexible tube 300 during the flow process , to reduce the probability of mechanical hemolysis of blood.

Referring to FIG. 7, in some embodiments of the present application, 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.

It can be understood that 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.

Specifically, in this embodiment, 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. Meanwhile, in order to make the blood flowing through the horizontal section 330 and the outlet section 350 evenly flow into the blood vessel 800 , the sidewall of the outlet section 350 is uniformly and spaced apart from a plurality of outflow windows 320 .

It can be understood that, 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.

After blood flows into the outlet section 350 from the horizontal section 330, since the inner diameter of the outlet section 350 gradually decreases from the distal end to the proximal end, the flow velocity of the blood flowing along the outlet section 350 will gradually increase. When the blood flows to the outflow window of the outlet section 350 At 320, 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.

Moreover, by setting the outflow window 320 on the lead-out section 350 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.

Referring again to FIG. 7 , in some embodiments, 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° °. According to the results of simulation calculations and experimental tests, when the shape and size of the transition section 340 and the horizontal section 330 constituting the flexible tube 300 meet the above conditions, 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.

In addition, referring to FIG. 7 , in this embodiment, 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. According to the results of simulation calculations and experimental tests, when the radius of the circle where the arc segment 331 is located is equal to the inner diameter of the horizontal segment 330, 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.

Similarly, 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 .

Referring again to FIGS. 1 to 7 , in some embodiments of the present application, 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. It can be understood that in this embodiment In this example, 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. Obviously, 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.

Referring to FIG. 8 , in some embodiments of the present application, 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 , and 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 .

It should be noted that, in this embodiment, after the blood pumping device is inserted into the patient's body, 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. In 700, 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. In 800, through the above-mentioned design, when the heart valve 900 is closed, 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 The reaction force of the flexible tube 300 against the heart valve 900. Considering that the operation time is long, the outer wall of the heart valve 900 and the flexible tube 300 will be squeezed against each other for a long time. By designing the flexible tube 300 into the above-mentioned shape and shortening the inner diameter of the second straight line segment 370, the blood flow is basically not affected. On the premise, the damage to the heart valve 900 caused by the outer wall of the flexible tube 300 can be effectively reduced.

In addition, in this embodiment, 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. Obviously, in this embodiment, 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°. In the end arc segment, 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. According to the results of simulation calculations and experimental tests, when the shapes and sizes of the first straight segment 360, the two arc segments 390, the second straight segment 370 and the third straight segment 380 constituting the flexible pipe 300 meet the above conditions, The extrusion damage of the outer wall of the flexible tube 300 to the heart valve 900 is minimal. Under the above conditions, the change in the flow rate of the entire blood pumping device pumped into the blood vessel 800 due to the shortening of the inner diameter D2 of the second straight section 370 is basically negligible. .

Table 1 below 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. During the best embodiment, the simulation test data comparison chart of the blood flow pumped into the blood vessel:

Table 1

As can be seen from Table 1, when the flexible tube 300 of the blood pumping device of the present application adopts the best embodiment of the flexible tube shown in FIG. 390, 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. At this time, 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.

Referring to Fig. 9 and Fig. 10, in some embodiments of the present application, 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 . Specifically, the two sections of the connecting pipe 130 can be connected as a whole by gluing or welding.

It can be understood that, by setting the pump casing 100 into a split structure, when installing the impeller 200, 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.

In other embodiments, 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.

Referring again to FIG. 11 and FIG. 12 , in some embodiments of the present application, 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 .

It should be noted that when the blood pumping device of the present application needs to enter the corresponding blood transfusion organ or blood vessel 800 through percutaneous surgery. In this embodiment, referring to 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.

In one embodiment, referring to FIG. 11 , 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. Through the above arrangement, the precision of the entire blood pumping device intervening in the patient's body is improved, thereby improving the precision of the operation, and at the same time, reducing the damage to the patient.

In another embodiment, referring to FIG. 12 , 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 After the path of the artery is extended so that the proximal end protrudes out of the body, 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. At this time, 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. Compared with the previous embodiments, 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.

Obviously, 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.

In addition, referring to FIG. 11 and FIG. 12 again, in this embodiment, the distal end of the guide tube 500 also has a preformed bend 510. It should be noted that when the guide tube 500 is sheathed on the guide wire 600 Firstly, 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. Utilizing 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. Obviously, 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 .

Referring to Fig. 2 and Fig. 3 again, in some embodiments of the present application, 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.

Specifically, in this embodiment, 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. Apparently, 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. Through this arrangement, all the particles generated by the operation of the distal part can be recovered outside the body, realizing Almost zero particles enter the body during the operation of the blood pump device.

If 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. In this embodiment, 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.

Of course, in this embodiment, in order to facilitate the extension of the transmission shaft 160 to the outside of the body to connect with the rotating drive member outside the body, 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 .

It should be noted that 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. In addition, in this embodiment, 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.

In addition, in other embodiments, 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.

The above is only the specific implementation of the embodiment of the present application, but the protection scope of the embodiment of the present application is not limited thereto. Any person familiar with the technical field can easily think of various Equivalent modification or replacement, these modifications or replacement should be covered within the scope of protection of the embodiments of the present application. Therefore, the protection scope of the embodiments of the present application should be determined by the protection scope of the claims.

Claims

A blood pumping device comprising:

The blood pump assembly includes a pump casing configured as a rigid tube structure and an impeller rotatably arranged in the pump casing, and at least one blood inlet is respectively opened on the distal peripheral surface and the proximal peripheral surface of the pump casing and blood outlets;

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, and the cavity of the flexible tube forms an outflow channel in communication with the blood outlet and the outflow window.
The blood pumping device of claim 1, wherein the flexible tube is shaped to:

Along its own length, it is wide in the middle and narrow at both ends;

Or, the two ends are wide and the middle is narrow along the length direction of itself.
The blood pumping device according to claim 1, wherein the central axis of the pump housing coincides with the central axis of the flexible tube, and the inner diameter of the flexible tube is larger than the outer diameter of the pump housing.
The blood pumping device according to any one of claims 1-3, wherein the flexible tube comprises a transition section, a horizontal section and a lead-out section smoothly connected in sequence, and the inner diameter of the transition section gradually increases from the distal end to the proximal end. increases, the inner diameter of the outlet section gradually decreases from the far end to the proximal end, the blood outlet faces the inner wall of the transition section, and the outflow window is opened on the side wall of the outlet section and connected to the horizontal section In parallel, the distal 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 blood pumping device according to claim 4, wherein 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 blood pumping device according to any one of claims 1-3, wherein the flexible tube comprises a first straight section, a second straight section and a third straight section which are sequentially and smoothly connected, the first straight section and The inner diameters of the third straight section are equal and larger than the inner diameter of the second straight section, and the two ends of the second straight section are smoothly connected to the first straight section and the third straight section through two arc sections respectively. The two ends of each are sealedly connected with the pump casing through the first straight section and the third straight section.
The blood pumping device according to claim 6, wherein the ratio of the inner diameter D1 of the first straight section to the inner diameter D2 of the second straight section is between 0.6 and 0.9; the length of the second straight section is between Between 6mm and 10mm.
The blood pumping device according to claim 1, wherein the pump casing is processed in one piece.
The blood pumping device according to claim 1, wherein the pump casing is formed by butting two sections of connecting tubes, wherein the outer wall of one section of the connecting tube is provided with a plurality of blood inlets along the circumference, and the outer wall of the other section of the connecting tube is along the A plurality of blood outlets are arranged in the circumferential direction, and the impeller is rotatably passed between two sections of the connecting pipe and is located between the blood inlet and the blood outlet.
According to the blood pumping device according to claim 1, the blood pumping assembly further comprises 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 The ends are sealingly connected with the outer wall of the pump casing and the outer wall of the sheath respectively.
According to the blood pumping device according to claim 1, the blood pumping assembly further comprises a rotary driving member arranged outside the body or inside the pump casing, the output end of the rotating driving member is directly or indirectly connected to the impeller, so as to The impeller is driven to rotate around itself.
The blood pumping device according to claim 1, wherein, 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 transmission shaft The distal end is coaxially connected to the proximal end of the rotating shaft.