CN113599692A

CN113599692A - Blood pump

Info

Publication number: CN113599692A
Application number: CN202110895435.7A
Authority: CN
Inventors: 余顺周
Original assignee: Shenzhen Core Medical Technology Co Ltd
Current assignee: Shenzhen Core Medical Technology Co Ltd
Priority date: 2021-08-05
Filing date: 2021-08-05
Publication date: 2021-11-05
Also published as: WO2023011054A1

Abstract

The invention relates to a blood pump, which is provided with a blood flow channel, a blood flow inlet and a blood flow outlet which are communicated with the blood flow channel, and comprises an impeller and a driving unit, wherein the impeller can rotate, the driving unit is arranged in the blood flow channel and is in transmission connection with the driving unit, the driving unit can drive the impeller to rotate, a gap for blood flow to pass is formed between channel walls of the blood flow channel by the driving unit, and the gap is communicated with the blood flow inlet and the blood flow outlet. The blood pump disclosed by the invention has higher pumping efficiency and can reduce blood damage.

Description

Blood pump

Technical Field

The invention relates to the field of medical devices, in particular to a blood pump which is inserted into a blood vessel of a patient through skin.

Background

Intravascular blood pumps, designed for percutaneous insertion into a patient's blood vessel, may be advanced along the blood vessel into the patient's heart to function as either a left ventricular assist device or a right ventricular assist device. Intravascular blood pumps are therefore also referred to as intracardiac blood pumps. The blood pump includes an impeller and a motor for driving the impeller to rotate, and when the impeller rotates, blood is delivered from a blood inlet of the blood pump to a blood outlet. The pumping efficiency of the blood pump is an important parameter of the performance index of the blood pump, but the pumping efficiency of the current intravascular blood pump is still low and needs to be improved.

Disclosure of Invention

Based on this, there is a need to provide a blood pump that is capable of higher pumping efficiency.

A blood pump having a blood flow passageway, and a blood flow inlet and a blood flow outlet in communication with the blood flow passageway, the blood pump comprising:

a rotatable impeller;

the driving unit is arranged in the blood flow channel and is in transmission connection with the impeller, the driving unit can drive the impeller to rotate, a gap for blood flow to pass through is formed between the driving unit and the channel wall of the blood flow channel, and the gap is communicated with the blood flow inlet and the blood flow outlet.

In one embodiment, the blood pump further comprises a flow tube comprising a radially expandable portion defining at least part of the blood flow passageway, the drive unit being received within the radially expandable portion, the drive unit and the radially expandable portion forming the gap therebetween.

In one embodiment, the radially expandable portion abuts the drive unit when unexpanded, and the gap is formed between the radially expandable portion and the drive unit when expanded.

In one embodiment, the radially expandable portion is expandable by injection of a liquid.

In one embodiment, at least a portion of the radially expandable portion is made of a flexible material.

In one embodiment, the radially expandable portion is a fluorinated ethylene propylene copolymer film, a polyethylene terephthalate film, or an E-PTFE film; alternatively, the material of the radially expandable portion is made of at least one of polyurethane, nylon, polyethylene, polyether block polyamide, and latex.

In one embodiment, the blood pump further comprises an inlet tube and a flow tube, the distal end of the flow tube is fixedly connected with the inlet tube, the proximal end of the inlet tube is connected to the drive unit, the drive unit is accommodated in the flow tube, the gap is formed between the drive unit and the flow tube, the blood flow inlet is arranged at the distal end of the inlet tube, and the blood flow outlet is arranged at the proximal end of the flow tube;

the inlet pipe is further provided with a first communication port, and the first communication port is communicated with the inlet pipe and the circulating pipe.

In one embodiment, the flow-through tube comprises a connected tube body and a distal transition section having an inner diameter that increases in a distal to proximal direction.

In one embodiment, the first communication opening is opened on the tube wall of the proximal end of the inlet tube, and the position of the first communication opening corresponds to the position of the distal transition section.

In one embodiment, the blood pump further comprises an inlet tube, a flow tube and an outlet tube, wherein the proximal end of the inlet tube is connected to the drive unit, the distal end of the outlet tube is connected to the drive unit, the distal end of the flow tube is fixedly connected to the inlet tube, the proximal end of the flow tube is fixedly connected to the outlet tube, the drive unit is accommodated in the flow tube, the gap is formed between the drive unit and the flow tube, the blood flow inlet is arranged at the distal end of the inlet tube, and the blood flow outlet is arranged at the proximal end of the outlet tube;

the inlet pipe is further provided with a first communicating port, the outlet pipe is further provided with a second communicating port, and the inlet pipe and the outlet pipe are communicated with the circulating pipe through the first communicating port and the second communicating port respectively.

In one embodiment, the flow tube comprises a tube body, and a distal transition section and a proximal transition section at both ends of the tube body; the inner diameter of the distal transition section is gradually increased along the direction from the distal end to the proximal end, and the inner diameter of the proximal transition section is gradually decreased along the direction from the distal end to the proximal end.

In one embodiment, the first communication port is opened on the tube wall of the proximal end of the inlet tube, and the position of the first communication port corresponds to the position of the distal transition section;

and/or the second communication opening is formed in the pipe wall at the far end of the outlet pipe, and the position of the second communication opening corresponds to the position of the near-end transition section.

In one embodiment, the blood pump further comprises a pigtail, a proximal end of the pigtail is connected to a distal end of the inlet tube, and a distal end of the pigtail is curved.

In one embodiment, the impeller is disposed in the blood flow passage and is adjacent to the blood flow inlet, and the gap is located between the blood flow inlet and the inflow outlet.

In one embodiment, the driving unit has a rotating shaft, and the rotating shaft is fixedly connected with the impeller.

an impeller rotatably provided in the blood flow channel;

a flow-through tube defining at least part of the blood flow passageway;

the driving unit is arranged in the blood flow channel and contained in the circulating pipe, the driving unit is in transmission connection with the impeller, the driving unit can drive the impeller to rotate, a gap for blood flow to pass through is formed between the driving unit and the circulating pipe, and the gap is communicated with the blood flow inlet and the blood flow outlet.

In one embodiment, the impeller is disposed proximate the blood flow inlet, and the drive unit is located between the blood flow outlet and the blood flow inlet.

In one embodiment, the flow tube includes a radially expandable portion defining at least part of the blood flow passageway, the radially expandable portion being located between the blood flow outlet and the blood flow inlet, the drive unit being received within the radially expandable portion, the drive unit and the radially expandable portion forming the gap therebetween.

In one embodiment, the radially expandable portion is capable of expanding upon injection of a liquid;

and/or, the material of at least partial section of the radial expandable part is flexible material;

and/or the material of the radial expandable part is fluorinated ethylene propylene copolymer film, polyethylene terephthalate film or E-PTFE film, or the material of the radial expandable part is made of at least one of polyurethane, nylon, polyethylene, polyether block polyamide and latex.

In conclusion, the blood pump disclosed by the invention has the following beneficial effects: the drive unit of this application is located the blood flow passageway of blood pump, and blood flows along drive unit's surface, and when the blood flow flowed through from drive unit's surface, the heat that drive unit produced can be taken away, helps the drive unit heat dissipation to reduce the damage that drive unit's the fever caused blood.

In addition, because the driving unit is positioned in the flow tube, the position of the blood outlet on the blood pump can not be influenced by the position of the driving unit, and the driving unit can be wholly pushed into the left ventricle during percutaneous intervention as long as the blood outlet is positioned at the target position, such as in an aorta or a pulmonary artery. Therefore, the output power of the driving unit can be increased by increasing the axial size of the driving unit, and the pumping efficiency of the blood pump is improved. Therefore, the blood pump of the invention is beneficial to improving the pumping efficiency.

In addition, because the material of at least part of the section of the radial expandable part of the circulating pipe is flexible, the driving unit is pushed into the left ventricle, so that the section of the flexible material of the radial expandable part is clamped between aortic valves, and when the aortic valves jump, the section of the radial expandable part of the circulating pipe can be radially extruded, so that pulsating flow is formed in the circulating pipe, and the actual blood flow can be better simulated.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the description of the embodiments of the present invention will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without inventive exercise.

FIG. 1 is a schematic diagram of a blood pump according to a first embodiment of the present invention;

FIG. 2 is a partial perspective view of the blood pump shown in FIG. 1;

FIG. 3 is an exploded view of the blood pump shown in FIG. 1;

FIG. 4 is a schematic structural diagram of a drive unit of a blood pump provided by the present invention;

FIG. 5 is a schematic structural diagram of a blood pump according to a second embodiment of the present invention;

fig. 6 is a partial perspective view of the blood pump shown in fig. 5.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. When a component is referred to as being "connected" to another component, it can be directly connected to the other component or intervening components may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In the field of interventional medicine, it is generally defined that the end of the instrument proximal to the operator is the proximal end and the end distal to the operator is the distal end.

Referring to fig. 1 and 2, a blood pump 100 according to a first embodiment of the present invention, and more particularly, to an intravascular blood pump 100, the blood pump 100 has a blood flow channel 110, and a blood flow inlet 112 and a blood flow outlet 114 communicated with the blood flow channel 110, wherein blood can enter the blood flow channel 110 from the blood flow inlet 112 and can be discharged from the blood flow outlet 114. The blood pump 100 includes, among other things, an impeller 120 and a drive unit 130.

Impeller 120 is disposed in blood flow passageway 110, and impeller 120 is rotatable to facilitate the entry of blood into blood flow passageway 110 from blood flow inlet 112 and the exit of blood from blood flow outlet 114. Specifically, impeller 120 is disposed proximate to blood flow inlet 112.

The driving unit 130 is disposed in the blood flow channel 110 and is in driving connection with the impeller 120, and the driving unit 130 can drive the impeller 120 to rotate. The driving unit 130 and the channel wall of the blood flow channel 110 form a gap 116 for blood flow to pass through, and the gap 116 is communicated with the blood flow inlet 112 and the blood flow outlet 114. That is, in the flow path of the blood, the gap 116 is located between the blood flow inlet 112 and the blood flow outlet 114, so that the blood entering the blood flow channel 110 from the blood flow inlet 112 flows through the gap 116 and then flows out from the blood flow outlet 114, thereby carrying away the heat generated by the driving unit 130 and helping the driving unit 130 to dissipate the heat.

In the illustrated embodiment, the blood pump 100 further includes an inlet tube 140, a flow-through tube 150, and an outlet tube 160.

Referring to fig. 3, the proximal end of the inlet tube 140 is fixedly connected to the driving unit 130, and the blood inlet 112 is disposed at the distal end of the inlet tube 140. The inlet pipe 140 further has a first communication opening 142.

Specifically, the blood flow inlet 112 is provided on the wall of the inlet tube 140; the blood flow inlet 112 is plural, and the plural blood flow inlets 112 are arranged at intervals in the circumferential direction of the inlet tube 140. The first communication port 142 is located at the proximal end of the inlet tube 140; the first communication openings 142 are a plurality of, and the plurality of first communication openings 142 are circumferentially spaced along the inlet tube 140 and uniformly distributed on the wall of the inlet tube 140. In one embodiment, the number of blood flow inlets 112 and first communication ports 142 is 4-6, respectively. It will be appreciated that the number of blood flow inlets 112 and the number of first communication ports 142 may be adjusted according to actual design requirements. Wherein the impeller 120 is rotatably provided to the inlet pipe 140.

The distal end of the flow tube 150 is fixedly connected to the inlet tube 140, and the flow tube 150 and the inlet tube 140 are communicated through the first communication port 142. Specifically, the proximal end of the inlet tube 140 is received in the flow tube 150. The driving unit 130 is accommodated in the flow pipe 150, and a gap 116 is formed between the driving unit 130 and the flow pipe 150. The distal end of the outlet tube 160 is received in the flow tube 150.

The distal end of the outlet tube 160 is connected to the drive unit 130 and the blood flow outlet 114 is provided at the proximal end of the outlet tube 160. The outlet pipe 160 is further opened with a second communicating opening 162, the proximal end of the flow pipe 150 is fixedly connected with the outlet pipe 160, and the flow pipe 150 is communicated with the outlet pipe 150 through the second communicating opening 162.

Then, in the present embodiment, the blood flow path 110 is defined by the inlet tube 140, the flow-through tube 150, and the outlet tube 160. At this time, the flow-through tube 150 defines part of the blood flow path 110. The drive unit 130 is located between the blood flow inlet 112 and the blood flow outlet 114. The blood enters the inlet tube 140 from the blood flow inlet 112, enters the flow tube 150 through the first communication port 142, flows through the gap 116 between the driving unit 130 and the flow tube 150, flows into the outlet tube 160 through the second communication port 162, and is finally discharged from the blood flow outlet 114.

Specifically, the blood flow outlet 114 is provided on the wall of the outlet tube 160; the blood flow outlet 114 is plural, and the plural blood flow outlets 114 are arranged at intervals along the circumference of the inlet tube 140. The second communication port 162 is located at the distal end of the outlet tube 160; the second communication openings 162 are plural, and the plural second communication openings 162 are spaced in the circumferential direction of the outlet pipe 160 and are uniformly distributed on the pipe wall of the outlet pipe 160. In one embodiment, the number of blood flow outlets 114 and second communication ports 162 is 4-6, respectively. It will be appreciated that the number of blood flow outlets 114 and the number of second communication ports 162 may be adjusted according to actual design requirements.

In one embodiment, the flow tube 150 includes a tube body 152, and a distal transition section 154 and a proximal transition section 156 at both ends of the tube body 152, the distal transition section 154 having an inner diameter that gradually increases in a distal-to-proximal direction and the proximal transition section 156 having an inner diameter that gradually decreases in a distal-to-proximal direction. The transition sections at the two ends of the tube main body 152 can make the blood flow in the vicinity of the first communication port 142 and the second communication port 162 smoothly transition, so that the blood pump 100 has more stable flow field distribution and excellent blood compatibility.

Specifically, in the illustrated embodiment, the inner diameter of the tube body 152 is equal along the distal to proximal ends, and the inner diameter of the distal transition section 154 at the end near the tube body 152 is equal to the inner diameter of the proximal transition section 156 at the end near the tube body 152. It should be noted that in other embodiments, the tube body 152 may be a tubular body having a varying inner diameter from the distal end to the proximal end.

Specifically, the first communication port 142 is located at a position corresponding to the distal transition section 154, the inner diameter of the distal transition section 154 is gradually increased in a distal-to-proximal direction, and the distal transition section 154 can smoothly transition the blood flowing out from the first communication port 142 in the diagonal flow direction to the axial flow direction.

The position of the second communication port 162 corresponds to the position of the proximal transition end, the inner diameter of the proximal transition section 156 is gradually decreased from the distal end to the proximal end, and the proximal transition section 156 can smoothly transition the blood from the axial flow direction to the oblique flow direction to better pass through the second communication port 162.

The change in the inner diameter of the distal transition section 154 and the proximal transition section 156 may be linear, may be a curve as shown, or may follow other curves.

In other embodiments, the proximal end of the distal transition section 154 and the proximal end of the first communication port 142 are located on the same cross section of the blood pump 100, and the distal end of the proximal transition section 156 and the distal end of the second communication port 162 are located on the same cross section of the blood pump 100, so that the blood flow near the two communication ports can run more smoothly.

Further, in order to prevent a large amount of blood from accumulating in the gap 116 between the flow tube 150 and the driving unit 130 and causing thrombus formation, the length of the second communication port 162 in the axial direction is larger than the length of the first communication port 142 in the axial direction, so that the blood in the gap 116 is rapidly discharged.

Specifically, the fixing point of the flow-through tube 150 to the inlet tube 140 is located between the blood flow inlet 112 and the first communication port 142. The fixed point of the flow tube 150 to the outlet tube 160 is between the blood flow outlet 114 and the second communication port 162. In the illustrated embodiment, the flow tube 150 further includes a proximal fixing section 157 and a distal fixing section 158, the proximal fixing section 157 is fixedly sleeved between the blood flow outlet 114 and the second communication port 162 of the outlet tube 160, and the distal fixing section 158 is fixedly sleeved between the first communication port 142 and the blood flow inlet 112 of the inlet tube 140. The proximal fixation section 157 is fixedly connected to an end of the proximal transition section 156 remote from the tube body 152, and the distal fixation section 158 is fixedly connected to an end of the distal transition section 154 remote from the tube body 152.

In one embodiment, the flow tube 150 includes a radially expandable portion that defines at least a portion of the blood flow passageway 110, the drive unit 130 is received within the radially expandable portion, and a gap 116 is formed between the drive unit 130 and the radially expandable portion. Then, during the process of advancing the blood pump 100 into the patient, the radially expandable portion is brought into an unexpanded state to reduce the delivery outer diameter of the blood pump 100 to facilitate advancement of the blood pump 100. In the illustrated embodiment, the radially expandable portion includes a tube body 152, and distal and

proximal transition sections

154, 156 at both ends of the tube body 152.

In one embodiment, the radially expandable portion abuts the drive unit 130 when unexpanded, and the radially expandable portion expands to form a gap 116 with the drive unit 130. The radially expandable portion abuts against the drive unit 130 when not radially expanded, so that the radially expandable portion has as small a radial width as possible when pushed in, enabling a reduction in the outer diameter of the blood pump 100 when delivered, for facilitating the pushing in of the blood pump 100.

In one embodiment, the radially expandable portion is expandable by injection of a liquid. Then, when blood enters the flow tube 150, the inner diameter of the radially expandable portion increases. The operation of expanding the radially expandable portion is accomplished by the injection of blood, such that, after the blood pump 100 is advanced into a target location in a patient, the radially expandable portion can be expanded by the injection of blood without further manipulation by an operator.

In one embodiment, the radially expandable portion is made of a flexible material, for example, the radially expandable portion may be made of an impermeable membrane material. Specifically, the material of the radially expandable portion is a fluorinated ethylene propylene copolymer film (FEP film), a polyethylene terephthalate film (PET film), or an E-PTFE film; alternatively, the material of the radially expandable portion is selected from at least one of polyurethane, nylon, polyethylene, polyether block Polyamide (PEBAX), and latex. These materials have good conformability and enable the expansible portion to expand (or swell) rapidly after blood injection. In addition, the radially expandable portion of the material pushes the driving unit 130 into the left ventricle, so that the radially expandable portion is clamped between the aortic valves, and when the aortic valves are beating, the radially expandable portion of the flow tube 150 is radially pressed, so that pulsating flow is formed in the flow tube 150, and the actual blood flow can be better simulated.

The material of the proximal fixation segment 157 and the distal fixation segment 158 may be the same as or different from the radially expandable portion.

In other embodiments, the radially expandable portion may be made of a flexible material only in a partial section. The flexible material can be fluorinated ethylene propylene copolymer film (FEP film), polyethylene terephthalate film (PET film) or E-PTFE film, or the flexible material is made of at least one of polyurethane, nylon, polyethylene, polyether block Polyamide (PEBAX) and latex. At this time, the driving unit 130 is pushed into the left ventricle, so that the section of the radially expandable portion made of flexible material is clamped between the aortic valves, and when the aortic valves are beating, the section of the radially expandable portion of the flow tube 150 is radially pressed, so that pulsating flow is formed in the flow tube 150, and actual blood flow is better simulated.

It should be noted that the radially expandable portion is not limited to being expanded by injecting a fluid, and in some embodiments, the radially expandable portion may be made of a shape memory material that can be expanded or contracted to fit against the driving unit 130 by means of heat (body temperature or other heat source) activation; in other embodiments, a retainer and release mechanism may also be provided to effect expansion of the radially expandable portion and to hold it against the drive unit 130.

It will be appreciated that the flow-through tube 150 is not limited to the above-described configuration, and in other embodiments, only the distal transition 154 or the proximal transition 156 may be attached to the tube body 152 of the flow-through tube 150, or the flow-through tube 150 may not have a transition, including only the tube body 152, or the flow-through tube 150 may not have a radial expansion function, and the inner diameter of the flow-through tube 150 may not change at all times.

The first communication port 142, the second communication port 162 and the driving unit 130 are not limited to the above arrangement, and in some embodiments, the first communication port 142 is disposed on an end surface of the proximal end of the inlet tube 140, and one end of the driving unit 130 close to the inlet tube 140 may be fixed to the proximal end of the inlet tube 140 or the inner wall of the flow tube 150 by a support bracket; in some embodiments, the second communication port 162 is disposed on an end surface of the distal end of the outlet tube 160, and an end of the driving unit 130 close to the outlet tube 160 may be fixed to the distal end of the outlet tube 160 or an inner wall of the flow tube 150 by a support bracket; in some embodiments, the first communication port 142 is disposed on the end surface of the proximal end of the inlet tube 140, the second communication port 162 is disposed on the end surface of the tube segment of the outlet tube 160, and the driving unit 130 is directly fixed in the flow tube 150 by the support frame; in some embodiments, the first communication port 142 and the second communication port 162 are still disposed as shown in fig. 1, however, the driving unit 130 is not fixedly connected to the outlet pipe 160 and the inlet pipe 140, but is directly fixedly connected to the flow pipe 150 through the supporting frame.

In the illustrated embodiment, the blood pump 100 further includes a conduit 170, the conduit 170 being fixedly attached to the proximal end of the outlet tube 160. The catheter 170 has a lumen for accommodating a pipeline, such as a cleaning pipeline, a lead wire electrically connected to the driving unit 130, etc., which extend to the outside of the proximal end of the catheter 170 and are connected to an external device, respectively.

In the illustrated embodiment, the blood pump 100 further comprises a pigtail 180, a proximal end of the pigtail 180 being connected to a distal end of the inlet tube 140, the distal end of the pigtail 180 being curved. The pigtail 180 may be used to stabilize the position of the blood pump 100 in the heart, providing atraumatic support for the heart tissue. Specifically, the pigtail 180 is a hollow structure. The distal end of the inlet tube 140 is provided with a perforation for communicating the lumen of the inlet tube 140 with the lumen of the pigtail 180 for the passage of a guide wire.

In one embodiment, the pigtail 180 is made of a material selected from at least one of polyurethane, nylon, polyethylene, PEBAX, and latex. The length of the pigtail 180 after being straightened along the axial direction is 10 mm-50 mm.

In one embodiment, the driving unit 130 has a rotating shaft, and the impeller 120 is fixed to the rotating shaft, so that the impeller 120 can rotate along with the rotating shaft.

Referring to fig. 4, in one embodiment, the driving unit 130 includes a housing 132, and a rotor 134 and a stator 136 disposed in the housing 132. The proximal end of the housing 132 is fixedly attached to the distal end of the outlet tube 160, and the distal end of the housing 132 is fixedly attached to the proximal end of the inlet tube 140.

The rotor 134 includes a rotating shaft 1342 and a magnet 1344 connected to each other, the rotating shaft 1342 is provided with a flywheel 1345, the magnet 1344 is mounted on the flywheel 1345, and a distal end of the rotating shaft 1342 extends out of the housing 132 and is fixedly connected to the impeller 120. The stator 136 includes a plurality of posts 1362 arranged around the axis of the rotating shaft 1342, a coil winding 1364 around the outer circumference of each post 1362, and a back plate 1366 connected to one end of the post 1362. The stator 136 has a passage extending axially through the center thereof, the rotating shaft 1342 passes through the passage, the coil winding 1364 generates a rotating magnetic field interacting with the magnet 1344 to rotate the rotating shaft 1342, so as to rotate the impeller 120, and the back plate 1366 is used to close a magnetic flux loop and increase the output power of the driving unit 130.

It should be noted that the driving unit 130 of the present embodiment is only used as an example, and is not used to limit the structure of the driving unit 130, in other embodiments, the driving unit 130 may also have other structures as long as the driving unit 130 can drive the impeller 120 to rotate, for example, in some embodiments, the driving unit 130 and the impeller 120 may also be in a non-contact transmission connection, for example, a magnetic transmission connection, and the like.

As follows, taking left ventricle assistance as an example, the blood pump 100 is implanted into the heart of a patient in a percutaneous intervention manner, and when the blood pump 100 works, blood in the left ventricle can be pumped into the aorta to assist blood circulation. The specific operation is as follows:

first, the distal end of the blood pump 100 is passed through the aortic valve and pushed into the left ventricle until the flow tube 150 is clamped in the aortic valve. In this case, the blood flow inlet 112 is located in the left ventricle and the blood flow outlet 114 is located in the aorta. Preferably, the aortic valve is clamped in the middle region of the flow tube 150.

Then, the driving unit 130 is activated, the driving unit 130 drives the impeller 120 to rotate, and when the impeller 120 operates, blood enters the blood pump 100 from the blood flow inlet 112 and is discharged from the blood flow outlet 114 through the blood flow channel 110 in the blood pump 100.

Because the flow tube 150 is clamped by the aortic valve, when the valve edge of the aortic valve jumps, the flow tube 150 is radially extruded, so that pulsating flow is formed in the flow tube 150, and the actual blood flow can be better simulated. In addition, the expanded flow tube 150 is made of a radially deformable flexible material, so that when the aortic valve presses the flow tube 150, damage to the aortic valve can be reduced.

Furthermore, since the drive unit 130 and the impeller 120 are pushed into the left ventricle, the axial dimension of the drive unit 130 is not limited by other conditions as long as the blood flow outlet 114 is located in the aorta. Therefore, the pumping efficiency of the impeller 120 can be improved by increasing the axial size of the driving unit 130 and increasing the output power of the driving unit 130.

It is understood that in other embodiments, the blood pump 100 of the present application may also be used as a right ventricular assist device to deliver the right ventricular blood pump 100 to the pulmonary artery.

The blood pump 100 described above has at least the following advantages:

(1) the driving unit 130 of the present embodiment is entirely located in the blood flow channel 110, and blood flows along the outer surface of the driving unit 130, so that when blood flows through the outer surface of the driving unit 130, heat generated by the driving unit 130 can be taken away, which is helpful for heat dissipation of the driving unit 130, so as to reduce damage to blood caused by heat generated by the driving unit 130.

(2) Since the driving unit 130 is located in the flow tube 150, the position of the blood flow outlet 114 of the blood pump 100 is not affected by the position of the driving unit 130, and the driving unit 130 can be pushed into the left ventricle as a whole during percutaneous intervention as long as the blood flow outlet 114 is located at the target position, such as in the aorta or the pulmonary artery. Therefore, the pumping efficiency of the blood pump 100 can be improved by increasing the axial size of the driving unit 130 and increasing the output power of the driving unit 130, and therefore, the blood pump 100 is beneficial to improving the pumping efficiency.

(3) Since at least a portion of the radially expandable portion of the flow tube 150 is made of a flexible material, the driving unit 130 is pushed into the left ventricle, so that the portion of the radially expandable portion made of the flexible material is clamped between the aortic valves, and when the aortic valves are beating, the portion of the radially expandable portion of the flow tube 150 is radially pressed, so that a pulsating flow is formed in the flow tube 150, and the actual blood flow can be better simulated.

Referring to fig. 5 and 6 together, a second embodiment of the present invention provides a blood pump 200 having a blood flow channel 210, and a blood flow inlet 212 and a blood flow outlet 214 communicated with the blood flow channel 210, wherein the blood pump 200 includes an impeller 220, a driving unit 230, an inlet tube 240, a flow tube 250, a catheter 270 and a pigtail 280.

The impeller 220 is drivingly connected to the drive unit 230, the proximal end of the inlet tube 240 is fixedly connected to the drive unit 230, and the impeller 220 is located in the inlet tube 240. The distal end of the catheter 270 is connected to the proximal end of the drive unit 230. The distal end of the inlet tube 240 is connected to the proximal end of the pigtail 280, and the distal end of the pigtail 280 is curved.

The distal end of the flow tube 250 is fixed to the inlet tube 240, the proximal end of the flow tube 240 is an open end, the driving unit 230 is accommodated in the flow tube 250, and a gap 216 for blood flow is formed between the flow tube 250 and the driving unit 230.

The blood flow inlet 212 is provided in the inlet tube 240, the inlet tube 240 is further provided with a first communicating hole 242, and the flow tube 250 and the inlet tube 240 communicate with each other through the first communicating hole 242. In this embodiment, the opening at the proximal end of the flow tube 250 is the blood flow outlet 214 of the blood pump 200. That is, in this embodiment, the inlet tube 240 and the flow-through tube 250 collectively define the blood flow path 210, in which case the flow-through tube 250 defines part of the blood flow path 210. The driving unit 230 is located in the blood flow path 210, specifically in the portion of the blood flow path 210 defined by the flow-through tube 250. Then, when the impeller 220 is operated, blood enters the inlet tube 240 from the blood inlet 212, enters the flow tube 250 through the first communication opening 242 of the inlet tube 240, flows through the gap 216, and is finally discharged through the blood outlet 214.

Since the driving unit 230 is entirely located in the blood flow channel 210, blood can flow along the outer surface of the driving unit 230, and when blood flows through the outer surface of the driving unit 230, heat generated by the driving unit 230 can be taken away, which helps the driving unit 230 to dissipate heat, and reduces damage to blood caused by heat generated by the driving unit 230. Further, since the drive unit 230 is positioned in the flow tube 250, the position of the blood outflow port 214 of the blood pump 200 can be kept from the influence of the drive unit 230, and the drive unit 230 can be pushed into the left ventricle as a whole during percutaneous intervention, so that the output of the drive unit 230 can be increased by increasing the axial dimension of the drive unit 230.

In other embodiments, the blood flow outlet 214 may also be provided on the wall of the flow tube 250. The proximal end of the flow tube 30 may also be secured to the drive unit 230.

In the illustrated embodiment, the flow tube 250 includes a tube body 252 and a distal transition section 254 connected, with the distal transition section 254 having an inner diameter that gradually increases in a distal-to-proximal direction. The distal transition section 254 is located near the first communication port 242, and the distal transition section 254 can make the blood flow near the first communication port 242 smoothly transition, so that the blood pump 200 has more stable flow field distribution and excellent blood compatibility.

The change in the inner diameter of the distal transition section 254 may be a linear progression or a particular curve along a formula.

In the illustrated embodiment, the first communication opening 242 opens into the proximal wall of the inlet tube 240, the first communication opening 242 being located at a position corresponding to the position of the distal transition section 254. The first communication port 242 is a plurality of first communication ports 242, and the plurality of first communication ports 242 are uniformly spaced apart along the circumferential direction of the inlet pipe 240.

In this embodiment, the point of attachment of the flow tube 250 to the inlet tube 240 is between the blood flow inlet 212 and the first communication port 242. Specifically, the flow-through tube 250 further includes a distal fixing section 258, and the distal fixing section 258 is fixedly sleeved between the first communication port 242 of the inlet tube 240 and the blood flow inlet 212. Distal fixation section 258 is fixedly attached to an end of distal transition section 254 distal to tube body 252.

In one embodiment, the flow tube 30 includes a radially expandable portion within which the drive unit 230 is received to reduce the delivery outer diameter of the blood pump 100. In the illustrated embodiment, the radially expandable portion includes a tube body 252 and distal transition sections 254 at both ends of the tube body 252.

In one embodiment, the radially expandable portion abuts the drive unit 230 when unexpanded, and the radially expandable portion expands to form a gap 216 with the drive unit 230. The radially expandable portion abuts against the drive unit 230 when not radially expanded, so that the radially expandable portion has as small a radial width as possible when pushed in, enabling a reduction in the outer diameter of the blood pump 200 at the time of delivery, for facilitating the pushing in of the blood pump 200.

In one embodiment, the radially expandable portion is expandable by injection of a liquid. Then, when blood enters the flow tube, the inner diameter of the radially expandable portion increases. The operation of expanding the radially expandable portion is accomplished by the injection of blood, such that, after the blood pump 200 is advanced into the target location in the patient's body, expansion of the radially expandable portion can occur by the injection of blood without further manipulation by the operator.

In one embodiment, the radially expandable portion is made of a flexible material, for example, the radially expandable portion can be made of a film-covered material with anti-seepage function, specifically, the radially expandable portion is made of a fluorinated ethylene propylene copolymer film (FEP film), a polyethylene terephthalate film (PET film), or an E-PTFE film; alternatively, the material of the radially expandable portion is selected from at least one of polyurethane, nylon, polyethylene, polyether block Polyamide (PEBAX), and latex. These materials have good conformability and enable the expansible portion to expand (or swell) rapidly after blood injection. Wherein the material of the distal anchoring segment may be the same as or different from the radially expandable portion.

In other embodiments, the radially expandable portion may be made of a flexible material only in a partial section. The flexible material can be fluorinated ethylene propylene copolymer film (FEP film), polyethylene terephthalate film (PET film) or E-PTFE film, or the flexible material is made of at least one of polyurethane, nylon, polyethylene, polyether block Polyamide (PEBAX) and latex. At this time, the driving unit 230 is pushed into the left ventricle to clamp the section of the flexible material of the radially expandable portion between the aortic valves, and when the aortic valves are beating, the section of the radially expandable portion of the flow tube 250 is radially compressed to form a pulsating flow in the flow tube 250, so as to better simulate the actual blood flow.

In this embodiment, the driving unit 230 is directly connected to the guide pipe 270. Since the structures of the pigtail 280, the inlet pipe 240, the impeller 240, the driving unit 230, and the guide pipe 270 are the same as those of the first embodiment, the detailed structures thereof will not be described herein.

Likewise, the blood pump 200 of the present embodiment can also be used as a left ventricular assist device or a right ventricular assist device, and the detailed operation thereof will not be described herein.

Since the structure of the blood pump 200 of the present embodiment is substantially the same as that of the blood pump 100 of the first embodiment, the blood pump 200 of the present embodiment also has the effect of the blood pump 100 of the first embodiment, and details thereof are not repeated herein.

It is understood that the blood pump may be configured differently from the blood pump 100 and the blood pump 200, and in other embodiments, the blood pump may not have an inlet tube and an outlet tube, the blood inlet and the blood outlet are respectively disposed on the flow tube and communicate with the inner cavity of the flow tube, the driving unit is fixed in the flow tube by the supporting frame, the impeller is disposed in the flow tube and is in transmission connection with the driving unit, and a gap is formed between the flow tube and the driving unit. At this time, the lumen of the circulation tube is the blood flow channel of the blood pump, i.e. the circulation tube defines the whole blood flow channel, and the driving unit is located in the blood flow channel. When the impeller is operated, blood enters the gap from the blood flow inlet and is then discharged through the blood flow outlet.

In other embodiments, the blood pump may further include an outlet tube instead of the inlet tube, the blood flow inlet may be disposed on the flow tube, the blood flow outlet may be disposed on the outlet tube, the proximal end of the flow tube may be fixedly connected to the outlet tube, the distal end of the outlet tube may be fixedly connected to the driving unit, and the driving unit may be fixedly connected to the flow tube via the support frame. Alternatively, the outlet pipe may not be fixedly connected to the driving unit, and the driving unit may be fixed to the flow pipe only by the support frame. In this aspect, the flow-through tube and the inlet tube together define a blood flow passageway.

In other embodiments, the pigtail may be omitted, or it may be replaced with other structures that provide atraumatic support to the heart tissue.

It is understood that the present invention is not limited to the above embodiments, and various modifications and changes can be made without departing from the spirit and scope of the present invention.

It is clear to those skilled in the art that, for convenience and brevity of description, the specific working processes of the above-described systems, apparatuses and units may refer to the corresponding processes in the foregoing method embodiments, and are not described herein again.

The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A blood pump having a blood flow passageway, and a blood flow inlet and a blood flow outlet in communication with the blood flow passageway, the blood pump comprising:

a rotatable impeller;

2. The blood pump of claim 1, further comprising a flow tube including a radially expandable portion defining at least part of said blood flow passageway, said drive unit being received within said radially expandable portion, said drive unit and said radially expandable portion forming said gap therebetween.

3. The blood pump of claim 2, wherein said radially expandable portion abuts said drive unit when unexpanded, said radially expandable portion forming said gap with said drive unit when expanded.

4. The blood pump of claim 2, wherein said radially expandable portion is expandable by injection of a liquid.

5. The blood pump of claim 2, wherein at least a portion of said radially expandable portion is flexible.

6. The blood pump according to any of claims 2 to 5, wherein the material of the radially expandable portion is a fluorinated ethylene propylene copolymer film, a polyethylene terephthalate film or an E-PTFE film; alternatively, the material of the radially expandable portion is made of at least one of polyurethane, nylon, polyethylene, polyether block polyamide, and latex.

7. The blood pump according to claim 1, further comprising an inlet tube and a flow tube having a distal end fixedly connected to the inlet tube, wherein a proximal end of the inlet tube is connected to the driving unit, the driving unit is accommodated in the flow tube, and the gap is formed between the driving unit and the flow tube, the blood inlet is disposed at the distal end of the inlet tube, and the blood outlet is disposed at the proximal end of the flow tube;

8. The blood pump of claim 7, wherein said flow tube comprises a connected tube body and a distal transition having an inner diameter that increases in a distal to proximal direction.

9. The blood pump according to claim 8, wherein said first communication opening opens on the wall of the proximal end of said inlet tube, the position of said first communication opening corresponding to the position of said distal transition section.

10. The blood pump according to claim 1, further comprising an inlet tube, a flow tube and an outlet tube, wherein a proximal end of said inlet tube is connected to said drive unit, a distal end of said outlet tube is connected to said drive unit, a distal end of said flow tube is fixedly connected to said inlet tube, a proximal end of said flow tube is fixedly connected to said outlet tube, said drive unit is accommodated in said flow tube, and said drive unit and said flow tube form said gap therebetween, said blood inlet is provided at the distal end of said inlet tube, and said blood outlet is provided at the proximal end of said outlet tube;

11. The blood pump of claim 10, wherein said flow tube comprises a tube body, and distal and proximal transitions at either end of said tube body; the inner diameter of the distal transition section is gradually increased along the direction from the distal end to the proximal end, and the inner diameter of the proximal transition section is gradually decreased along the direction from the distal end to the proximal end.

12. The blood pump according to claim 11, wherein said first communication port opens on the tube wall of the proximal end of said inlet tube, the position of said first communication port corresponding to the position of said distal transition section;

13. The blood pump of any of claims 7 to 12, further comprising a pigtail, a proximal end of the pigtail being connected to a distal end of the inlet tube, a distal end of the pigtail being curved.

14. The blood pump of claim 1, wherein said impeller is disposed in said blood flow passageway adjacent said blood flow inlet, and said gap is located between said blood flow inlet and said inflow outlet.

15. The blood pump according to claim 1, wherein said drive unit has a shaft, said shaft being fixedly connected to said impeller.

16. A blood pump having a blood flow passageway, and a blood flow inlet and a blood flow outlet in communication with the blood flow passageway, the blood pump comprising:

an impeller rotatably provided in the blood flow channel;

a flow-through tube defining at least part of the blood flow passageway;

17. The blood pump of claim 16, wherein said impeller is disposed proximate said blood flow inlet, and said drive unit is located between said blood flow outlet and said blood flow inlet.

18. The blood pump of claim 16, wherein said flow tube includes a radially expandable portion defining at least part of said blood flow passageway, said radially expandable portion being located between said blood flow outlet and said blood flow inlet, said drive unit being received within said radially expandable portion, said drive unit and said radially expandable portion forming said gap therebetween.

19. The blood pump of claim 18, wherein said radially expandable portion abuts said drive unit when unexpanded, said radially expandable portion forming said gap with said drive unit when expanded.

20. The blood pump of claim 18 or 19, wherein said radially expandable portion is expandable by the action of an injected liquid;