CN114259645A

Movatterモバイル変換

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Publication number: CN114259645A
Application number: CN202210028952.9A
Authority: CN
Inventors: 唐智荣; 赵贤忠; 薛志宽; 徐玲艳
Original assignee: Fengkaili Medical Instrument Shanghai Co ltd
Current assignee: Fengkaili Medical Instrument Shanghai Co ltd
Priority date: 2022-01-11
Filing date: 2022-01-11
Publication date: 2022-04-01
Anticipated expiration: 2042-01-11
Also published as: WO2023134693A1; CN114259645B

Abstract

The application discloses pump blood device, this pump blood device includes: the blood pumping assembly comprises a pump shell configured into a rigid pipe structure and an impeller rotatably arranged in the pump shell, wherein the periphery of the near end and the periphery of the far end of the pump shell are respectively provided with at least one blood inlet and one blood outlet; the flexible pipe is configured to be an elastic hose structure with an expandable and contractible outer wall, is arranged on the pump shell and covers the blood outlet, at least one outflow window is arranged on the circumferential surface, an outflow channel communicated with the blood outlet and the outflow window is formed by a cavity of the flexible pipe, and the shape of the flexible pipe is configured to be as follows: the middle part of the body is wide and the two ends are narrow along the length direction of the body; or the two ends of the material are wider and the middle is narrower along the length direction of the material. The utility model provides a blood pumping device utilizes the flexible characteristic of flexible tube can effectively reduce the damage to patient's heart valve to utilize the expandable and contractive structural feature of flexible tube, shortened the stroke that blood flows, increased the blood flow of pump sending to the blood vessel by a wide margin.

Description

Blood pumping device

Technical Field

The embodiment of the application belongs to the technical field of heart auxiliary devices, and particularly relates to a blood pumping device.

Background

Percutaneous Coronary Intervention (PCI) is a commonly used effective method for treating coronary heart disease, and compared with the heart bypass surgery, the PCI surgery has the advantages of lower risk, smaller wound, lower surgery difficulty and quicker postoperative recovery. In addition, PCI surgery is also applicable to the rescue of acute myocardial infarction by rapidly restoring perfusion of the blood flow occluding the blood vessels to restore the patient's myocardial status.

The artificial ventricle auxiliary device capable of being implanted through skin is miniaturized blood pumping equipment, the blood pumping performance of the artificial ventricle auxiliary device is completely determined by the operation mode of a blood pump, the artificial ventricle auxiliary device is independent of the physical state of a patient, and the artificial ventricle auxiliary device belongs to active blood circulation supporting equipment. The artificial ventricle auxiliary device can be implanted through a PCI operation, can provide more stable blood circulation support for a patient in a high-risk PCI operation, improves the perfusion of coronary artery and a far-end organ, simultaneously reduces the burden of the heart, and is favorable for the stability of physical signs of the patient in the operation and the rehabilitation after the operation.

The core component of the artificial ventricle auxiliary device is a blood pumping conduit. Conventional pump catheters generally include an aspiration channel, a transvalvular tube, and an outflow channel. Because the conventional transvalve tube usually has a certain rigidity, the front part of the pump blood catheter is stabilized during the intervention of the pump blood catheter in the patient. However, during the operation, because the operation time is long, the transvalve tube with certain rigidity can be located at the heart valve for a long time and is in contact with the heart valve for a long time, so that the heart valve has the problems of swelling, functional damage and the like, and the injury is caused to the human body. Furthermore, due to the presence of the transvalvular tube, the stroke between the suction channel and the outflow channel is long, which can cause a loss of blood flow pumped into the blood vessel.

Disclosure of Invention

The present application is directed to solving at least one of the problems in the prior art. Therefore, the application provides a blood pumping device, and its structure is ingenious, can effectively reduce the damage to heart valve to can effectively improve the transport flow of blood.

A blood pumping device according to an embodiment of the present application includes:

the blood pumping assembly comprises a pump shell configured into a rigid pipe structure and an impeller rotatably arranged in the pump shell, wherein the periphery of the near end and the periphery of the far end of the pump shell are respectively provided with at least one blood inlet and one blood outlet;

the flexible tube is configured into an elastic hose structure with an expandable and contractible outer wall, is arranged on the pump shell and covers the blood outlet, at least one outflow window is arranged on the peripheral surface of the flexible tube, and an outflow channel communicated with the blood outlet and the outflow window is formed in a cavity of the flexible tube.

The blood pumping device has at least the following beneficial effects:

the utility model provides a blood pumping device is through setting up the flexible tube on the pump case to with the flexible tube configuration for the outer wall can expand with the elasticity hose construction that contracts, compare with traditional pump blood pipe, the valve pipe has been striden to traditional rigidity has been replaced to the flexible tube, utilizes the flexible characteristic of flexible tube can effectively reduce the damage to patient's heart valve. Meanwhile, the flexible tube is skillfully arranged on the pump shell, and the expandable and contractive structural characteristics of the flexible tube are utilized, on the premise of not changing the rotating speed of the impeller, the flowing stroke of blood is shortened, the flow of the blood pumped into the blood vessel is greatly increased, and the flexible tube synchronously expands and contracts under the opening and closing actions of the heart valve, so that the whole blood pumping device generates pulsatile blood flow or pulsatile blood flow output matched with the diastolic and contractive characteristics of the heart of a patient, the perfusion of the coronary artery and a far-end organ is improved, the heart burden is lightened, and the stability of the physical signs of the patient in an operation and the postoperative rehabilitation are facilitated. In addition, by arranging the pump shell into a rigid tube structure, the traditional rigid valve-spanning tube is eliminated, and the distance between the blood inlet and the blood outlet is shortened, so that blood can rapidly flow into the flexible tube and then into the blood vessel. Meanwhile, the rigid pump shell not only plays a role in supporting and bearing the flexible pipe, so that the flexible pipe can be stably expanded by blood in an inflated manner or compressed by a heart valve, irregular expansion or contraction deformation of the flexible pipe due to uneven stress is avoided, the stability of blood flowing in the flexible pipe is ensured, the pump shell is ensured not to deform unacceptably under the action of certain pressure and bending force, and the structural stability of the pump shell and an impeller in the pump shell is ensured.

According to some embodiments of the application, the shape of the flexible tube is configured to:

the middle part of the body is wide and the two ends are narrow along the length direction of the body;

or the two ends of the material are wider and the middle is narrower along the length direction of the material.

According to some embodiments of the present application, the central axis of the pump casing coincides with a centerline axis of the flexible tubing, the flexible tubing having an inner diameter greater than an outer diameter of the pump casing.

According to some embodiments of the application, the flexible tube comprises a transition section, a horizontal section and a leading-out section which are smoothly connected in sequence, wherein the inner diameter of the transition section is gradually increased from the far end to the near end, the inner diameter of the leading-out section is gradually reduced from the far end to the near end, the blood outlet faces to the inner wall of the transition section, the outflow window is arranged on the side wall of the leading-out section and is parallel to the horizontal section, and the far end and the near end of the flexible tube are respectively connected to the outer wall of the pump shell in a sealing mode through the transition section and the leading-out section.

According to some embodiments of the present application, the transition section is smoothly connected to the horizontal section through an arc section, and a radius of a circle where the arc section is located is equal to an inner diameter of the horizontal section.

According to some embodiments of the present application, the pump housing is integrally formed.

According to some embodiments of the present application, the pump housing is formed by two sections of connecting pipes detachably connected in an abutting manner, wherein an outer wall of one section of the connecting pipe is provided with a plurality of blood inlets along a circumferential direction, an outer wall of the other section of the connecting pipe is provided with a plurality of blood outlets along the circumferential direction, and the impeller is rotatably arranged between the two sections of the connecting pipe and between the blood inlets and the blood outlets.

According to some embodiments of the application, the blood pumping assembly further comprises a sheath tube, the sheath tube is arranged in the outflow channel in a penetrating mode and connected to the near end of the pump shell, and two ends of the flexible tube are respectively connected with the outer wall of the pump shell and the outer wall of the sheath tube in a sealing mode.

According to some embodiments of the present application, the blood pumping assembly further comprises a guiding hose disposed at the distal end of the pump housing and a guide wire disposed in the guiding hose, wherein the distal end of the guide wire can extend out of the distal end of the guiding hose, and the proximal end of the guide wire can extend out of the proximal end of the guiding hose or the blood inlet of the pump housing.

According to some embodiments of the present application, the blood pumping assembly further comprises a rotary drive disposed outside the body or within the pump housing, an output end of the rotary drive being directly or indirectly connected to the impeller to drive the impeller to rotate about itself.

According to some embodiments of the present application, a bearing seat, a rotating shaft, and a transmission shaft are provided in the pump housing, the rotating shaft is provided in the bearing seat through a bearing, the impeller is suspended on the rotating shaft, and a distal end of the transmission shaft is coaxially connected to a proximal end of the rotating shaft.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments of the present application will be briefly described below, and it is obvious that the drawings described below are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a first schematic structural view of a blood pumping device according to some embodiments of the present application;

FIG. 2 is a schematic structural diagram of a blood-pumping device according to some embodiments of the present application;

fig. 3 is a partial enlarged view at a in fig. 2;

FIG. 4 is a third schematic structural view of a blood pumping device according to some embodiments of the present application;

FIG. 5 is a schematic structural view of a blood-pumping device according to some embodiments of the present application after insertion into a patient;

FIG. 6 is another schematic illustration of a blood-pumping device according to some embodiments of the present application after insertion into a patient;

FIG. 7 is a schematic illustration of a pump casing and flexible tubing mating arrangement according to some embodiments of the present application;

FIG. 8 is a schematic view of another mating arrangement of a pump housing and a flexible tube according to some embodiments of the present application;

FIG. 9 is a schematic illustration of one construction of a pump casing according to some embodiments of the present application;

FIG. 10 is an exploded view of a pump casing according to some embodiments of the present application;

FIG. 11 is a fourth schematic structural view of a blood pumping device according to some embodiments of the present application;

fig. 12 is a schematic structural diagram of a blood pumping device according to some embodiments of the present application.

In the drawings: apump housing 100; ablood inlet 110; ablood outlet 120; aconnection pipe 130; abearing housing 140; arotating shaft 150; adrive shaft 160; abearing 170; animpeller 200; aflexible tube 300; anoutflow channel 310; anegress window 320; ahorizontal section 330; acircular arc segment 331; atransition section 340; a lead-out segment 350; a firststraight line segment 360; a secondstraight line segment 370; the thirdstraight line segment 380; anarc segment 390; asheath 400; aguide hose 500; acurved portion 510; aguidewire 600; aventricle 700; ablood vessel 800; aheart valve 900.

Detailed Description

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 present application. It will be apparent, however, to one skilled in the art that the embodiments of the present application may be practiced without some of these specific details. The following description of the embodiments is merely intended to provide a better understanding of the present application by illustrating examples thereof.

In the description of the present application, it should be understood that the orientation or positional relationship referred to in the description of the orientation, such as the upper, lower, front, rear, left, right, etc., is based on the orientation or positional relationship shown in the drawings, and is only for convenience of describing the embodiments of the present application and simplifying the description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the embodiments of the present application.

In the description of the embodiments of the present application, the meaning of a plurality of means is one or more, the meaning of a plurality of means is two or more, and more than, less than, more than, etc. are understood as excluding the present number, and more than, less than, etc. are understood as including the present number. If the first and second are described for the purpose of distinguishing technical features, they are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

In the description of the embodiments of the present application, unless otherwise explicitly limited, terms such as setting, installing, connecting and the like should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the terms in the present application in combination with the specific contents of the technical solutions.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The embodiments will be described in detail below with reference to the accompanying drawings.

In addition, it should be noted that, in the description of the embodiments of the present application, "in vivo" means in a tissue organ of a patient and "in vitro" means outside the tissue organ of the patient, unless otherwise specifically defined. Meanwhile, in the embodiments of the present application, "distal" refers to a direction away from the physician, and "proximal" refers to a direction closer 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 blood in the left ventricle flows into the aorta under systolic pressure, so that the aorta is transfused into the tissue and organs of the human body; at the same time, the pulmonary valve between the right ventricle and the pulmonary artery is opened, and the blood in the right ventricle flows into the pulmonary artery, so that the pulmonary artery transfuses blood into the pulmonary vein and branch organs of the human body. When the heart relaxes, the aortic valve closes, and blood in the aorta is prevented from flowing back to the left ventricle; at the same time, the pulmonary valve closes, preventing blood in the pulmonary artery from flowing back into the right ventricle. The aorta of the human body is sequentially divided into ascending aorta, aortic arch and descending aorta along the blood flowing direction, and the ascending aorta, the aortic arch and the descending aorta are sequentially communicated.

The causes of coronary heart disease or other cardiovascular diseases mainly show that blood cannot flow to cardiac muscle or brain in time, resulting in hypoxia necrosis of organ tissues. The blood pumping device of this application can provide stable blood circulation for patient's heart and support to can reduce the damage to patient's heart valve, simultaneously, compare with traditional pump blood pipe, reduce the loss of blood flow, alleviate heart burden when improving coronary artery and distal organ perfusion volume, be favorable to patient's sign in the art and stable and the postoperative is recovered.

Referring to fig. 1, 2, 3 and 4, the present application discloses a blood pumping device comprising a blood pumping assembly and aflexible tube 300.

The blood pumping assembly comprises apump casing 100 configured as a rigid tube structure and animpeller 200 rotatably disposed in thepump casing 100, wherein at least oneblood inlet 110 and oneblood outlet 120 are respectively opened on the proximal circumferential surface and the distal circumferential surface of thepump casing 100. Theflexible tube 300 is configured as an elastic hose structure with an expandable and contractible outer wall, theflexible tube 300 is disposed in thepump housing 100 and covers theblood outlet 120, at least oneoutflow window 320 is opened on the circumferential surface of theflexible tube 300, and the cavity of theflexible tube 300 forms anoutflow channel 310 communicating with theblood outlet 120 and theoutflow window 320.

Also, the shape of theflexible tube 300 is configured to: the middle part of the body is wide and the two ends are narrow along the length direction of the body; or the two ends of the material are wider and the middle is narrower along the length direction of the material.

It should be understood that the cavity of thepump housing 100 is in communication with theblood inlet 110 and theblood outlet 120 for blood flow. Thepump casing 100 is a rigid structure to ensure structural stability of thepump casing 100 and theimpeller 200 provided therein, and to play a role in supporting and bearing theflexible tube 300. Thepump casing 100 can be made of stainless steel, PEEK, POM and other materials with mechanical strength and high density, so that thepump casing 100 is ensured not to deform unacceptably under certain pressure and bending force, and the structural stability of thepump casing 100 and theimpeller 200 therein is ensured. It should be noted that, before the blood pumping device of the present application is inserted into the patient, theflexible tube 300 is in the initial contracted state, and after the blood pumping device is inserted into the patient, the whole blood pumping device operates, and blood continuously flows into theoutflow channel 310 formed by the cavity of theflexible tube 300, so as to expand the volume of theflexible tube 300, and theoutflow channel 310 is kept in the expanded state after being filled with blood.

Specifically, theflexible tube 300 may be in an olive-shaped configuration, and the inner and outer walls thereof are arc surfaces, so that the connection between theflexible tube 300 and thepump housing 100 is in arc transition, and blood can smoothly flow from theblood outlet 120 into theoutflow channel 310 formed by the cavity of theflexible tube 300. The overall profile of theflexible tube 300 is streamlined, so that the resistance of blood flowing through theoutflow channel 310 is reduced, the smoothness of blood flowing along theblood outlet 120, theoutflow channel 310 and theoutflow window 320 is ensured, the impact of blood flowing into theoutflow channel 310 and flowing through theoutflow channel 310 on theflexible tube 300 is reduced, the blood is prevented from impacting the inner wall of theflexible tube 300 as much as possible, and the probability of mechanical hemolysis of blood is reduced.

See fig. 5 and 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, a physician may introduce the blood pumping device into a patient through a percutaneous operation, such that thepump housing 100 with theflexible tube 300 disposed thereon is synchronously crossed over theheart valve 900, and such that thepump housing 100 is partially or completely located in theventricle 700 of the patient, such that theblood inlet 110 on thepump housing 100 is communicated with theventricle 700, and at the same time, theflexible tube 300 is located between theventricle 700 and theblood vessel 800 communicated with theventricle 700 across theheart valve 900, such that theoutflow window 320 on theflexible tube 300 is communicated with theblood vessel 800, and such that theheart valve 900 of the patient contacts only the outer wall of theflexible tube 300.

When the whole blood pumping device operates, theimpeller 200 rotates, and blood in theventricle 700 continuously enters the cavity of thepump housing 100 from theblood inlet 110 under the power of theimpeller 200, then flows into theoutflow channel 310 formed by the cavity of theflexible tube 300 through theblood outlet 120, and finally flows into theblood vessel 800 from theoutflow window 320, so that the blood delivery is completed.

In the blood conveying process, due to the structural characteristic that theflexible tube 300 is an elastic flexible tube, after blood continuously enters theoutflow channel 310, the volume of theflexible tube 300 is continuously expanded and increased, when the volume of theflexible tube 300 is expanded to the maximum state, theflexible tube 300 is in the filling state, the caliber of theoutflow window 320 arranged on theflexible tube 300 is synchronously expanded to the maximum, at the moment, the blood flow flowing through theoutflow channel 310 and the blood flow flowing into theblood vessel 800 from theoutflow window 320 both reach the maximum values, and the blood flow conveyed into theblood vessel 800 by the whole blood pumping device is greatly increased under the condition that the rotating speed of theimpeller 200 is not changed.

When theheart valve 900 is closed, the valve leaflets of theheart valve 900 are mutually involuted, so that the outer wall of theflexible tube 300 is squeezed, theflexible tube 300 is contracted along the involution straight line of the valve leaflets, the caliber of theoutflow channel 310 is greatly reduced, even theoutflow channel 310 is completely closed, and blood cannot flow into theblood vessel 800; when theheart valve 900 opens, theflexible tube 300 is again expanded to a maximum state under the pressure of the blood, and the blood flow again flows into theblood vessel 800 at a maximum flow rate. As the patient'sheart valve 900 is continuously opened and closed, theflexible tube 300 synchronously expands and contracts, thereby generating pulsatile blood flow or pulsatile blood flow output that is adapted to the diastolic and systolic characteristics of the patient's heart, improving perfusion of the coronary and distal organs while reducing cardiac burden, facilitating the stabilization of the patient's physical signs during and rehabilitation after surgery.

It should be noted that in the above description, theventricle 700 may correspond to the left ventricle or the right ventricle of the patient, theblood vessel 800 corresponds to the aorta communicating with the left ventricle or the pulmonary artery communicating with the right ventricle, and thecorresponding 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 scenario of the blood pumping device of the present application is not limited to the left ventricle and aorta, the right ventricle and pulmonary artery, but can also be applied to other tissues and organs of the human body to play a role in assisting blood pumping.

Compared with the traditional blood pumping catheter, theflexible tube 300 replaces the traditional rigid valve spanning tube and the damage to theheart valve 900 of the patient can be effectively reduced by utilizing the flexibility characteristic of theflexible tube 300 through arranging theflexible tube 300 on thepump shell 100 and configuring theflexible tube 300 into the elastic hose structure with the expandable and contractible outer wall.

Meanwhile, theflexible tube 300 is skillfully arranged on thepump shell 100, and the expandable and contractible structural characteristics of theflexible tube 300 are utilized, on the premise of not changing the rotating speed of theimpeller 200, the flowing stroke of blood is shortened, the blood flow pumped into theblood vessel 800 is greatly increased, and theflexible tube 300 is synchronously expanded and contracted under the opening and closing actions of theheart valve 900, so that the whole blood pumping device generates pulsatile blood flow or pulsatile blood flow output matched with the diastolic and contractible characteristics of the heart of a patient, the perfusion of the coronary artery and a remote organ is improved, the heart burden is reduced, and the stability of the physical signs of the patient in operation and the postoperative rehabilitation are facilitated.

Furthermore, by utilizing the expandable and contractible structural characteristics of theflexible tube 300, theflexible tube 300 is in the initial contraction state before being inserted into the patient, at this time, the inner diameter and the volume of theflexible tube 300 are both in the minimum state, and the physician can insert theflexible tube 300 in this state into the position of theheart valve 900 of the patient through percutaneous surgery, so as to reduce the operation wound area to the maximum extent, and at the same time, improve the blood pumping flow rate of the whole blood pumping device under the same operation wound area.

Further, by providing thepump housing 100 as a rigid tube structure, the conventional rigid transvalved tube is eliminated, reducing the distance between theblood inlet 110 and theblood outlet 120, allowing blood to flow rapidly into theflexible tube 300 and, thus, into the blood vessel. Meanwhile, therigid pump casing 100 not only plays a role in supporting and bearing theflexible tube 300, so that theflexible tube 300 can be stably expanded by blood filling or compressed by theheart valve 900, irregular expansion or contraction deformation of theflexible tube 300 due to uneven stress is avoided, the stability of blood flow in the flexible tube is ensured, but also thepump casing 100 is ensured not to have unacceptable deformation under certain pressure and bending force, and the structural stability of thepump casing 100 and the impeller in the pump casing is ensured.

Referring to fig. 1, 2, 3 and 4 again, in some embodiments of the present application, the central axis of thepump housing 100 coincides with the centerline axis of theflexible tube 300, and the inner diameter of theflexible tube 300 is larger than the outer diameter of thepump housing 100, it is easily understood that theflexible tube 300 is symmetrical to the central axis or the extension line of the central axis of thepump housing 100, so that the blood flows into theoutflow channel 310 from theblood outlet 120, and then the volume of theoutflow channel 310 is uniformly expanded, and at the same time, the blood flow flowing into theblood vessel 800 is effectively increased, and the linearity of the blood flowing in theoutflow channel 310 is ensured, so that the blood is further prevented from hitting the inner wall of theflexible tube 300 during the flowing process, and the probability of mechanical hemolysis of the blood is reduced.

Referring to fig. 7, in some embodiments of the present application, the flexible tube comprises atransition section 340, ahorizontal section 330 and a leading-outsection 350 which are smoothly connected in sequence, wherein the inner diameter of thetransition section 340 gradually increases from the distal end to the proximal end, the inner diameter of the leading-outsection 350 gradually decreases from the distal end to the proximal end, the blood outlet is towards the inner wall of thetransition section 340, the outflow window is opened on the side wall of the leading-outsection 350 and is parallel to thehorizontal section 330, and the distal end and the proximal end of the flexible tube are hermetically connected to the outer wall of the pump housing through thetransition section 340 and the leading-outsection 350 respectively.

It is understood that the inner diameter of thehorizontal section 330 is larger than the inner diameters of thetransition section 340 and the leading-outsection 350, thetransition section 340 and the leading-outsection 350 are mirror images of thehorizontal section 330, and theflexible pipe 300 is formed by integrally molding thetransition section 340, thehorizontal section 330 and the leading-outsection 350.

Specifically, in the present embodiment, a plurality ofblood outlets 120 are uniformly and intermittently disposed on the peripheral surface of the distal end of thepump casing 100, the port of thetransition section 340 is annularly and hermetically connected to the outer wall of thepump casing 100, and all theblood outlets 120 are located inside thetransition section 340, so as to ensure that the blood uniformly flows into thetransition section 340. Meanwhile, in order to make the blood flowing through thehorizontal section 330 and thederivation section 350 uniformly flow into theblood vessel 800, the sidewall of thederivation section 350 is provided with a plurality ofoutflow windows 320 uniformly and spaced apart.

It will be appreciated that when blood flows from theblood outlet 120 into theoutflow channel 310, the blood will first contact the inner wall of thetransition section 340 and flow along the inner wall of thetransition section 340 to thehorizontal section 330 due to theblood outlet 120 facing the inner wall of thetransition section 340. Because the inner diameter of thetransition section 340 gradually increases from the distal end to the proximal end, the flow velocity of the blood flowing along thetransition section 340 gradually decreases, and when the blood flows to the junction of thetransition section 340 and thehorizontal section 330, the flow velocity of the blood reaches the minimum, and the kinetic energy of the blood flow impacting the inner wall of theflexible tube 300 is reduced to the minimum, so as to reduce the probability of mechanical hemolysis of the blood flow.

After the blood flows into the leading-outsection 350 from thehorizontal section 330, the flow rate of the blood flowing along the leading-outsection 350 is gradually increased due to the gradual decrease of the inner diameter of the leading-outsection 350 from the distal end to the proximal end, and the flow rate of the blood is substantially maximized when the blood flows to theoutflow window 320 of the leading-outsection 350, so that the blood flows into the blood vessel from theoutflow window 320 at the blood flow rate, thereby increasing the blood flow rate into the blood vessel.

Moreover, by arranging theoutflow window 320 on the leading-outsection 350 in a state parallel to thehorizontal section 330, the blood flowing out of theoutflow window 320 is ensured to flow along the axis of theblood vessel 800 at a large flow rate, the linearity of the blood flowing into theblood vessel 800 is ensured, meanwhile, the blood flowing out of theoutflow window 320 is prevented from impacting the wall of theblood vessel 800 by shooting to the wall of theblood vessel 800, and the blood flowing out of theoutflow window 320 is also prevented from generating vortex flow due to the change of the flow direction, thereby preventing the generation of irregular blood flow and avoiding the adverse effect on the patient.

Referring again to fig. 7, in some embodiments, thetransition section 340 is a slope or a curved surface with a curvature approaching zero, and the ratio between the outer diameter of thehorizontal section 330 and the minimum outer diameter at the port of thetransition section 340 is greater than 1 and less than or equal to 3, and the optimal ratio is 5/3; meanwhile, the included angle between the main boundary of thetransition section 340 and the central axis of thehorizontal section 330 is greater than or equal to 45 ° and less than 90 °, and the optimal included angle is 60 °. According to the results of simulation calculation and experimental test, when the shapes and sizes of thetransition section 340 and thehorizontal section 330 constituting theflexible tube 300 satisfy the above conditions, the probability of mechanical hemolysis of the blood flow flowing from theblood outlet 120 into theoutflow channel 310 is the lowest, i.e. under the above conditions, the kinetic energy of the blood flow impacting theflexible tube 300 can be minimized, the probability of mechanical hemolysis of the blood flow is reduced to the maximum extent, and the risk of other diseases brought to the patient by the mechanical hemolysis is eliminated as much as possible.

In addition, referring to fig. 7 again, in the present embodiment, thetransition section 340 is smoothly connected to thehorizontal section 330 through thecircular arc section 331, and by the design of thecircular arc section 331, the blood flow in thetransition section 340 can smoothly flow into thehorizontal section 330, so as to realize smooth transition from the oblique flow to the horizontal flow. According to the results of simulation calculation and experimental tests, when the radius of the circle where thecircular arc section 331 is located is equal to the inner diameter of thehorizontal section 330, the smooth transition effect of the blood flow is optimal, and the probability of mechanical hemolysis of the blood flow in the flowing process is further reduced.

Referring again to fig. 1 to 7, in some embodiments of the present application, in order to ensure structural stability of theflexible tube 300 in an initial contracted state before being filled with blood and in an expanded state after being filled with blood, the blood pumping assembly further includes asheath 400, thesheath 400 is inserted into theoutflow channel 310 and connected to the proximal end of thepump housing 100, and two ends of theflexible tube 300 are respectively and sealingly connected to the outer wall of thepump housing 100 and the outer wall of thesheath 400, it can be understood that, in this embodiment, the distal end of thetransition section 340 and the proximal end of thehorizontal section 330 are respectively and sealingly connected to the outer wall of thepump housing 100 and the outer wall of thesheath 400, obviously, thepump housing 100 and thesheath 400 together play a role of supporting and bearing theflexible tube 300, so that theflexible tube 300 can be stably expanded by blood filling or compressed by theheart valve 900, and irregular expansion or contraction deformation of theflexible tube 300 due to uneven stress can be avoided, ensuring the stability of blood flow therein.

It should be noted that, in this embodiment, after the blood pumping device is inserted into the patient, theflexible tube 300 is inserted between theventricle 700 and theblood vessel 800 communicating with theventricle 700, and the firststraight line segment 360 extends into theventricle 700 completely, the secondstraight line segment 370 just crosses theheart valve 900 between theventricle 700 and theblood vessel 800, so that the leaflets of theheart valve 900 only contact the outer wall of the secondstraight line segment 370, and the thirdstraight line segment 380 is located in theblood vessel 800 completely, and with the above design, when theheart valve 900 is closed, the force of theheart valve 900 pressing theflexible tube 300 to make theheart valve 900 press the outer wall of theflexible tube 300 during contraction can be reduced, and accordingly, the reaction force of theflexible tube 300 on theheart valve 900 can be reduced. Considering that the operation time is long, theheart valve 900 and the outer wall of theflexible tube 300 can be mutually squeezed for a long time, the inner diameter of the secondstraight section 370 is shortened by designing theflexible tube 300 into the shape, and the damage of the outer wall of theflexible tube 300 to theheart valve 900 can be effectively reduced on the premise of basically not influencing the blood flow.

In addition, in the present embodiment, the ratio of the inner diameter of the firststraight line segment 360 to the secondstraight line segment 370 is between 0.6 and 0.9, and the optimal value is 0.85; the length of the secondstraight line segment 370 is between 6mm and 10 mm; thearc segment 390 is respectively tangent to the firststraight segment 360 and the secondstraight segment 370, obviously, in this embodiment, thearc segment 390 is formed by smoothly connecting two arc segments, among the tangents on thearc segment 390, the included angle between the tangent with the largest slope and the central axis of the firststraight segment 360 is in the range of 30 ° to 60 °, the optimal value is 42 °, meanwhile, in the arc segments at the two ends forming thearc segment 390, the radius length of the circle where the arc segment tangent to the firststraight segment 360 is located is between 5mm and 10mm, the optimal value is 8mm, the radius length of the circle where the arc segment tangent to the secondstraight segment 370 is also between 5mm and 10mm, and the optimal value is 6 mm. According to the results of simulation calculation and experimental tests, when the shapes and sizes of the firststraight line segment 360, the twoarc line segments 390, the secondstraight line segment 370 and the thirdstraight line segment 380 which form theflexible tube 300 meet the above conditions, the extrusion damage of the outer wall of theflexible tube 300 to theheart valve 900 is minimal, and under the above conditions, the amount of flow change of the whole blood pumping device which is pumped into theblood vessel 800 due to the reduction of the inner diameter of the secondstraight line segment 370 is basically negligible.

Table 1 below is a graph comparing simulated test data of the blood flow rate pumped into the blood vessel when the blood pumping device of the present application is applied to the preferred embodiment of the flexible tube shown in fig. 7 and the preferred embodiment of the flexible tube shown in fig. 8 under the same pressure difference between theblood inlet 110 and the blood outlet 120:

TABLE 1

As can be seen from table 1, when theflexible tube 300 of the blood pumping device of the present application adopts the preferred embodiment of the flexible tube shown in fig. 8, that is, when the shapes and sizes of the firststraight line segment 360, the twoarc segments 390, the secondstraight line segment 370 and the thirdstraight line segment 380 constituting theflexible tube 300 satisfy the following conditions:

the ratio of the inner diameter of the firststraight line segment 360 to the inner diameter of the secondstraight line segment 370 is 0.85, the length of the secondstraight line segment 370 is between 6mm and 10mm, the included angle between the tangent line with the largest slope and the central axis of the firststraight line segment 360 in the tangent lines on thearc line segment 390 is 42 degrees, the radius length of the circle where the arc segment tangent to the firststraight line segment 360 is located in the arc segments at the two ends of thearc line segment 390 is 8mm, the radius of the circle where the arc segment tangent to the secondstraight line segment 370 is located is 6mm, and the shape and the size parameters of the firststraight line segment 360 and the thirdstraight line segment 380 are the same. At this time, the compression injury of theheart valve 900 by the outer wall of theflexible tube 300 is not only minimized, but also the amount of change of the flow rate of the whole blood pumping device pumped into theblood vessel 800 by theflexible tube 300 of the present embodiment due to the shortening of the inner diameter of the secondstraight section 370 is only 0.09L/min to 0.2L/min, which is substantially negligible, compared with the flexible tube shown in fig. 8.

Referring to fig. 9 and 10, in some embodiments of the present application, thepump casing 100 is formed by two sections of connectingpipes 130 detachably connected to each other, wherein the outer wall of one section of connectingpipe 130 is circumferentially provided with a plurality ofblood inlets 110, the outer wall of the other section of connectingpipe 130 is circumferentially provided with a plurality ofblood outlets 120, and theimpeller 200 is rotatably inserted between the two sections of connectingpipes 130 and between theblood inlets 110 and theblood outlets 120. Specifically, the two connectingtubes 130 may be connected into a whole by gluing or welding.

It can be understood that, by configuring thepump casing 100 as a split structure, when theimpeller 200 is installed, the two sections of the connectingpipes 130 can be detached first, then theimpeller 200 is accurately installed in one section of the connectingpipe 130, so that the central axis of theimpeller 200 coincides with the central axis of the connectingpipe 130, and then the other section of the connectingpipe 130 is butted, so that the wholetubular pump casing 100 is coaxial with theimpeller 200, the installation accuracy of theimpeller 200 is ensured, further, blood flows uniformly, and the occurrence probability of mechanical hemolysis of blood flow is further reduced.

In other embodiments, thepump casing 100 may be formed by integral processing, which can reduce the number of parts and the complexity of the process, and avoid the parts from falling off due to adhesion or welding, thereby improving the safety and stability of the device during operation in vivo.

Referring again to fig. 11 and 12, in some embodiments of the present application, the blood pumping assembly further includes a guidinghose 500 disposed at the distal end of thepump housing 100 and aguide wire 600 disposed through the guidinghose 500, wherein the distal end of theguide wire 600 may extend out of the distal end of the guidinghose 500, and the proximal end of theguide wire 600 may extend out of the proximal end of the guidinghose 500 or theblood inlet 110 of thepump housing 100.

It should be noted that the blood pumping device of the present application is required to access the corresponding blood transfusion organ orblood vessel 800 through percutaneous surgery. In this embodiment, referring to fig. 5, 6, 11 and 12, taking the left ventricle and the aorta communicating with the left ventricle as an example of an application scenario, when the blood pumping device enters the left ventricle along the aorta, it needs to pass through the superficial cut, the aorta vessel, the aortic arch and cross the aortic valve.

In one embodiment, referring to fig. 11, the operating physician may insert theguide wire 600 into the left ventricle according to a predetermined path in advance, and extend theguide wire 600 along the path of the aorta so that the proximal end of theguide wire 600 extends out of the body, and then sleeve theguide hose 500 arranged at the distal end of thepump housing 100 on the proximal end of theguide wire 600 and enter the left ventricle along the track of theguide wire 600, so that theguide hose 500 can drive thepump housing 100 and theflexible tube 300 on thepump housing 100 to the corresponding positions of the left ventricle and the aorta under the guidance of theguide wire 600, at this time, the proximal end of theguide wire 600 extends out of the proximal end of theguide hose 500, thereby completing the precise intervention of the whole blood pumping device. Through the setting, the precision of the whole blood pumping device in the body of a patient is improved, the precision of an operation is further improved, and meanwhile, the damage to the patient is reduced.

In another embodiment, referring to fig. 12, the guidinghose 500 is communicated with theblood inlet 110 on thepump housing 100, the operating physician inserts theguide wire 600 into the left ventricle according to a predetermined path in advance, and extends theguide wire 600 along the path of the aorta so that the proximal end of theguide wire 600 extends out of the body, and then the guidinghose 500 arranged at the distal end of thepump housing 100 is sleeved on the proximal end of theguide wire 600 and enters the left ventricle along the track of theguide wire 600, so that the guidinghose 500 can drive thepump housing 100 and theflexible tube 300 on thepump housing 100 to the corresponding positions of the left ventricle and the aorta under the guidance of theguide wire 600, at this time, the proximal end of theguide wire 600 passes through the guidinghose 500 and theblood inlet 110 on thepump housing 100 and extends out of theblood inlet 110, thereby completing the precise intervention of the whole blood pumping device. Compared with the previous embodiment, theguide wire 600 has a longer passing path in the blood pumping device, so that the stability of the whole blood pumping device along the passing stroke of theguide wire 600 is increased, the operation of a doctor is facilitated, and the efficiency of percutaneous operation of the doctor is improved.

Obviously, this application not only has made things convenient for the doctor to promptly intervene whole pump blood device to corresponding blood transfusion organ through the setting ofseal wire 600 and guidehose 500, has still improved the accuracy that whole pump blood device intervenes to corresponding blood transfusion organ, has reduced the damage to the patient to a certain extent.

In addition, referring to fig. 11 and 12, in the present embodiment, the distal end of the guidingtube 500 further has apre-formed bending portion 510, and it should be noted that when the guidingtube 500 is sleeved on theguide wire 600, the distal end of the bendingportion 510 is firstly sleeved on theguide wire 600 and extends to a linear state along theguide wire 600, so as to drive thewhole guiding tube 500, thepump housing 100 and theflexible tube 300 on thepump housing 100 to the corresponding positions of the left ventricle and the aorta, and then the physician withdraws theguide wire 600, and the bendingportion 510 recovers the original memory shape again, preferably, the bendingportion 510 is in the shape of a pigtail. By utilizing the arc-shaped profile of the bendingpart 510, the blood in the ventricle can flow into theblood inlet 110 along the track of the bendingpart 510 and then flow into theblood vessel 800, and obviously, the arrangement of the bendingpart 510 plays a role in drainage, so that the blood can flow into theblood vessel 800 quickly under the power action of theimpeller 200.

Referring again to fig. 2 and 3, in some embodiments of the present application, the blood pumping assembly further comprises a rotary drive (not shown) disposed externally of thepump housing 100 or disposed within the pump housing, an output end of the rotary drive being directly or indirectly connected to theimpeller 200 to drive theimpeller 200 to rotate about itself.

Specifically, in this embodiment, abearing seat 140, arotating shaft 150 and a drivingshaft 160 are disposed in thepump housing 100, therotating shaft 150 is disposed in thebearing seat 140 through abearing 170, theimpeller 200 is suspended on therotating shaft 150, a distal end of the drivingshaft 160 is coaxially connected to a proximal end of therotating shaft 150, the proximal end of the drivingshaft 160 is connected to a rotary driving member, which may be a power component such as a motor or a motor, and the specific structure thereof is not limited. Obviously, the rotary driving member drives theimpeller 200 to rotate by driving thetransmission shaft 160 and therotary shaft 150 to rotate, so as to output the blood pumping driving force for the whole blood pumping device.

Theimpeller 200 is suspended on therotating shaft 150, that is, the proximal end of theimpeller 200 is connected to therotating shaft 150, and the distal end is a free end, so that all particles generated by the operation of the distal component can be recovered to the outside of the body, and almost zero particles enter the body in the operation process of the blood pumping device.

If the impeller adopts both ends bearing structure, impeller distal end and near-end all are provided with bearing structure promptly, to the bearing structure of impeller distal end, the wearing and tearing granule that produces in the operation process can't be retrieved to external, can only get into internally, produces the adverse reaction easily, influences the security of product. In this embodiment, therotating shaft 150 is disposed in the bearinghousing 140 through thebearing 170, and thebearing 170 may be two ball bearings, which is beneficial to using the gap between the ball bearings to realize the perfusion fluid carrying particles to flow back to the outside of the body.

Thepump casing 100 of the present embodiment is configured as a rigid pipe structure, and can provide sufficient support for theimpeller 200 in a cantilever structure, so as to achieve the purpose of high product flow and zero particles.

Of course, in this embodiment, in order to facilitate thetransmission shaft 160 to extend to the outside of the body to be connected with the external rotary driving member, thesheath 400 is inserted through the middle of theflexible tube 300, one end of thesheath 400 is hermetically connected with the proximal end of thepump housing 100, the other end of thesheath 400 extends out of theflexible tube 300 and extends outwards along the path of theblood vessel 800, thetransmission shaft 160 is inserted into thesheath 400 and extends to the outside of the body to be connected with the rotary driving member, through the arrangement of thesheath 400, thetransmission shaft 160 is prevented from directly contacting with the blood in theblood vessel 800 to affect the physiological function of the blood, and meanwhile, thesheath 400 also plays a role in supporting and bearing theflexible tube 300, thereby ensuring the structural stability of theflexible tube 300.

It should be noted that thesheath 400 is a flexible and bendable structure, does not cause structural damage to the correspondingblood vessel 800 or blood transfusion organ, and can be well adapted to the bent or coiled shape of the corresponding blood line. In addition, in the present embodiment, thetransmission shaft 160 may be a transmission twisted wire to adapt to the curved shape of thesheath 400 after being inserted into the body, while ensuring its transmission performance.

An injection inlet pipeline and an injection outlet pipeline are arranged in thesheath pipe 400, so that particles generated when the cantilever-supported impeller runs are all returned to the outside of the body.

Additionally, in other embodiments, the rotary drive is disposed directly within thepump casing 100 and has an output end directly connected to theimpeller 200 to directly drive the impeller to rotate.

The above description is only a specific implementation of the embodiments of the present application, but the scope of the embodiments of the present application is not limited thereto, and any person skilled in the art can easily conceive various equivalent modifications or substitutions within the technical scope of the embodiments disclosed in the present application, and these modifications or substitutions should be covered by the scope of the embodiments of the present application. Therefore, the protection scope of the embodiments of the present application shall be subject to the protection scope of the claims.

Claims

1. A blood pumping device, comprising:

2. The blood pumping device of claim 1, wherein the flexible tube is shaped to:

3. The blood pumping apparatus of claim 1, wherein the central axis of the pump housing coincides with the centerline axis of the flexible tube, the flexible tube having an inner diameter greater than an outer diameter of the pump housing.

4. The blood pumping device according to claim 1, 2 or 3, wherein the flexible tube comprises a transition section, a horizontal section and a leading-out section which are smoothly connected in sequence, the inner diameter of the transition section is gradually increased from a distal end to a proximal end, the inner diameter of the leading-out section is gradually decreased from the distal end to the proximal end, the blood outlet is towards the inner wall of the transition section, the outflow window is opened on the side wall of the leading-out section and is parallel to the horizontal section, and the distal end and the proximal end of the flexible tube are respectively connected with the outer wall of the pump shell in a sealing way through the transition section and the leading-out section.

5. The blood pumping device of claim 4, wherein the transition section is smoothly connected to the horizontal section by a circular arc section, wherein the radius of the circle on which the circular arc section is located is equal to the inner diameter of the horizontal section.

6. The blood pumping device according to claim 1, 2 or 3, wherein the flexible tube comprises a first straight line section, a second straight line section and a third straight line section which are smoothly connected in sequence, the inner diameters of the first straight line section and the third straight line section are equal and are larger than that of the second straight line section, two ends of the second straight line section are smoothly connected with the first straight line section and the third straight line section through two arc line sections respectively, and two ends of the flexible tube are hermetically connected with the pump shell through the first straight line section and the third straight line section respectively.

7. The blood pumping apparatus of claim 1, wherein the pump housing is integrally formed.

8. The blood pumping device of claim 1, wherein the pump housing is formed by two segments of connecting pipes, the outer wall of one segment of the connecting pipe is provided with a plurality of blood inlets along the circumferential direction, the outer wall of the other segment of the connecting pipe is provided with a plurality of blood outlets along the circumferential direction, and the impeller is rotatably arranged between the two segments of the connecting pipe and between the blood inlets and the blood outlets.

9. The blood pumping device of claim 1, wherein the blood pumping assembly further comprises a sheath tube inserted into the outflow channel and connected to the proximal end of the pump housing, and two ends of the flexible tube are respectively connected to the outer wall of the pump housing and the outer wall of the sheath tube in a sealing manner.

10. The apparatus according to claim 1, wherein the blood pumping assembly further comprises a guiding tube disposed at the distal end of the pump housing and a guide wire disposed in the guiding tube, the distal end of the guide wire can extend out of the distal end of the guiding tube, and the proximal end of the guide wire can extend out of the proximal end of the guiding tube or the blood inlet of the pump housing.

11. The blood pumping device of claim 1, wherein the blood pumping assembly further comprises a rotary drive member disposed outside the body or within the pump housing, an output end of the rotary drive member being directly or indirectly coupled to the impeller to drive the impeller to rotate about itself.

12. The blood pumping device of claim 1, wherein the pump housing defines a bearing seat therein, a rotating shaft, and a drive shaft, the rotating shaft is received in the bearing seat by a bearing, the impeller is suspended from the rotating shaft, and a distal end of the drive shaft is coaxially coupled to a proximal end of the rotating shaft.