CN117100995A - ventricular assist device - Google Patents
ventricular assist device Download PDFInfo
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- CN117100995A CN117100995A CN202311068444.4A CN202311068444A CN117100995A CN 117100995 A CN117100995 A CN 117100995A CN 202311068444 A CN202311068444 A CN 202311068444A CN 117100995 A CN117100995 A CN 117100995A
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- 230000002861 ventricular Effects 0.000 title claims abstract description 57
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- 238000007789 sealing Methods 0.000 claims description 11
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- 238000006243 chemical reaction Methods 0.000 claims description 4
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- 238000002513 implantation Methods 0.000 claims description 4
- 239000003146 anticoagulant agent Substances 0.000 claims description 3
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- 210000005240 left ventricle Anatomy 0.000 description 8
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- 230000035487 diastolic blood pressure Effects 0.000 description 2
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/021—Measuring pressure in heart or blood vessels
- A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/021—Measuring pressure in heart or blood vessels
- A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
- A61B5/02152—Measuring pressure in heart or blood vessels by means inserted into the body specially adapted for venous pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
- A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
- A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
- A61M60/554—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3327—Measuring
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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Abstract
The application discloses a ventricular assist device, which relates to the field of medical equipment, and comprises a catheter pump and a controller, wherein the catheter pump is used for being implanted into a heart of a human body, a pressure sensor of the catheter pump is configured to measure the aortic static pressure in the heart, and a motor component of the catheter pump is configured to provide current I and rotating speed omega; the user interface is used for adjusting the current I and the rotating speed omega, converting the current I and the rotating speed omega into pressure difference delta p data and transmitting the pressure difference delta p data to the controller; the controller is also used for receiving the aortic static pressure p from the pressure sensor and converting the aortic static pressure p into the total aortic pressure AO; and the controller converts the data of the total aortic pressure AO and the pressure difference deltap into left ventricular pressure LV, and correspondingly regulates and controls current I and rotating speed omega according to the left ventricular pressure LV to realize closed-loop feedback of the ventricular assist device.
Description
Technical Field
The application relates to the field of medical instruments, in particular to a ventricular assist device.
Background
Ventricular assist devices can provide short-term or long-term hemodynamic support for heart failure patients, the basic principle of which is to complete a circulatory assist by inserting the device into the left ventricle of the patient to draw blood out, and delivering the blood through a tube to the aorta under the power provided by a blood pump. The ventricular assist device assists the heart in pumping blood, thereby reducing the heart load.
Although a catheter heart blood pump is one of the implementation modes, hemodynamics can be provided for heart failure patients to help the heart failure patients recover heart functions, in general, individual differences of the patients lead to different systolic pressure and diastolic pressure of the heart, but the heart functions of the heart failure patients are not sound, and the systolic pressure and the diastolic pressure of the heart failure patients are in abnormal ranges, so how to help the heart of the patients to return to normal levels through intelligent control of the heart blood pump is a problem to be solved urgently in the field of heart blood pumps.
Disclosure of Invention
The application provides a ventricular assist device which can realize closed-loop feedback, namely, the left ventricular pressure of a patient is obtained through parameters such as current, rotating speed and the like, and the parameters such as current I, rotating speed omega and the like are controlled in real time through the left ventricular pressure.
A ventricular assist device, comprising: a catheter pump for implantation in a human heart, comprising a pressure sensor configured to measure aortic static pressure in the heart and a motor assembly configured to provide a current I and a rotational speed ω;
the controller is used for adjusting the current I and the rotating speed omega and converting the current I and the rotating speed omega into pressure difference delta p data to be transmitted to a user interface of the controller, and the conversion equation of the pressure difference delta p data is as follows:
Δp＝f 1 (ω)×I+f 2 (ω)，
wherein f 1 (ω)＝4.7e -17 ×ω 4 -7.2e 12 ×ω 3 ，
f 2 (ω)＝-3.6e -14 ×ω 4 +5.5e 23 ×ω 3 ；
The aortic static pressure p is received from the pressure sensor and converted into the aortic total pressure AO, and the conversion equation of the aortic total pressure AO is as follows:
and converting the data of the total aortic pressure AO and the pressure difference deltap into left ventricular pressure LV, and correspondingly regulating and controlling current I and rotating speed omega by the controller according to the left ventricular pressure LV to realize closed-loop feedback of the ventricular assist device.
As one embodiment, the pressure sensor includes a flow guiding portion at the distal end, a first slot for guiding blood and allowing blood to enter the first slot, and a chip for sensing the pressure of blood flowing in through the first slot as aortic static pressure.
As an embodiment, the pressure sensor comprises a distal body having a receiving cavity near a proximal end of the first slot, the chip being disposed in the receiving cavity, a gap being left between the distal end of the chip and the proximal end of the first slot for buffering an impact force of blood flowing in through the first slot, the distal end being an end remote from an operator.
As one embodiment, the motor assembly comprises a motor, a pump housing, the motor configured to provide a current I and a rotational speed ω, the motor outer surface being provided with a second slot for receiving the pressure sensor distal body, the pump housing outer surface being provided with an elongated slot for receiving the pressure sensor distal tip, the elongated slot comprising a diversion tip for mating with a diversion portion of the pressure sensor.
As one embodiment, the catheter pump comprises a delivery catheter, the motor assembly comprises a tail cap, the delivery catheter is fixedly connected with the tail cap, the proximal end of the pressure sensor is connected with the controller through an optical fiber, the proximal body of the pressure sensor is accommodated in the delivery catheter, and a third slot is formed in the tail cap for enabling the proximal body of the pressure sensor to extend out of the delivery catheter and enter the second slot.
As one embodiment, the motor assembly further comprises an impeller, the impeller being housed within the pump housing; the pump shell is provided with an outlet, the outlet is arranged at the proximal end of the impeller, and the pump shell is used for rectifying blood and enabling the blood to flow out from the outlet at the proximal end of the impeller after flowing through the impeller so as to reduce the impact force of the blood on blood vessels.
As one embodiment, the catheter pump further comprises an inlet tube, and a composite sleeve, wherein the distal end of the composite sleeve is connected with the inlet tube, the proximal end of the composite sleeve is fixedly connected with the motor assembly, the inlet tube comprises an inlet, and the motor assembly drives the impeller so that blood enters the catheter pump from the inlet and flows out from the outlet of the pump shell.
As one embodiment, the catheter pump further comprises a sealing system, wherein the proximal end of the sealing system is fixed to the controller, the distal end of the sealing system is connected with the catheter pump, and the sealing system is used for supplying flushing fluid to the catheter pump so as to prevent coagulation during the operation of the catheter pump.
As an embodiment, the impeller surface is provided with an anti-coagulant coating comprising an inert layer for isolating the impeller from blood and an active layer coating the exterior of the inert layer.
As an example, the outer surface of the composite sleeve is provided with a hydrophilic coating for reducing blood resistance of the ventricular assist device when entering the human body.
The application has the beneficial effects that: and the pressure sensor is utilized to acquire the aortic static pressure p of the patient, the controller is utilized to calculate the total aortic pressure AO and the pressure difference delta p according to the parameter data such as the current I, the rotating speed omega and the like, the left ventricular pressure LV of the patient is finally obtained, and the parameters such as the current I, the rotating speed omega and the like are regulated and controlled according to the left ventricular pressure LV of the patient in a targeted manner, so that the closed-loop feedback of the ventricular assist device is realized.
Drawings
FIG. 1 is a schematic diagram of the main components of a ventricular assist system;
FIG. 2 is a schematic diagram of a catheter pump configuration;
FIG. 3 is a schematic illustration of a catheter pump implantation site;
FIG. 4 is a view of a pipe entry structure;
FIG. 5 is a schematic diagram of a motor assembly;
FIG. 6 is an enlarged schematic view of the motor tail cap;
FIG. 7 is a schematic diagram of a motor construction;
FIG. 8 is a schematic view of a pump housing construction;
FIG. 9 is a block diagram of a pressure sensor;
fig. 10 is a schematic diagram of aortic pressure and left ventricular pressure.
Detailed Description
The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the application. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
The terms "first," "second," "third," and the like in this disclosure are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. In the description of the present application, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.
In the embodiment of the application, the proximal end is the end close to the operator, and the distal end is the end far away from the operator.
Referring to fig. 1, the present application provides a ventricular assist device, which mainly comprises a catheter pump 1, a sealing system 2 and a controller 3, wherein the catheter pump 1 is arranged at the distal end of the ventricular assist device for implantation into a heart of a human body; the controller 3 is used for regulating and controlling relevant parameters of the catheter pump, such as current I, rotating speed omega and the like, the controller 3 regulates and controls the relevant parameters and transmits relevant parameter data to a user interface of the controller, an operator can acquire data from the user interface and timely adjust the state of the catheter pump 1 according to the parameters so as to help the heart index of a patient to be better recovered to a normal range, and the catheter pump 1 is in signal connection with the controller 3. The sealing system 2 provides a channel through which the flushing fluid flows to prevent coagulation during operation of the catheter pump 1.
In an embodiment of the present application, catheter pump 1 is configured to be inserted into a heart site of a human body, and catheter pump 1 includes, in order from distal end to proximal end, an inlet tube 10, a composite cannula 20, a motor assembly 30, and a delivery catheter 40, the distal end portions of inlet tube 10 and composite cannula 20 being positioned in the left ventricle of the patient, the proximal end portion of composite cannula 20 and motor assembly 30 being positioned in the aorta of the patient, and delivery catheter 40 being positioned in the arterial vessel of the patient and extending outside the body. Referring to fig. 3, catheter pump 1 is positioned in the left ventricle and aorta of a patient, and blood enters the catheter pump from inlet tube 10 and partially into the arterial vessel at motor assembly 30.
As an example, catheter pump 1 is provided with a pressure sensor 50 and a motor assembly 30, the pressure sensor 50 being positioned in the aorta and configured to measure the static pressure p in the aorta, and the motor assembly 30 being configured to provide the catheter pump 1 with a current I and a rotational speed ω. In the present application, the controller 3 is used to adjust the current I and the rotational speed ω of the catheter pump 1 and to convert the current I and the rotational speed ω into pressure difference Δp data for transmission to the user interface of the controller 3.
Specifically, a part of the catheter pump 1 is positioned in the left ventricle, the other part of the catheter pump 1 is positioned in the aorta, a pressure difference exists between the left ventricle and the aorta, the catheter pump 1 accords with a current-pressure difference-rotating speed model, the flow I and rotating speed omega parameters of the catheter pump 1 influence the pressure difference delta p data of the catheter pump 1, and after 2 parameters are determined, the 3 rd parameter can be determined, namely, the controller 3 can calculate the pressure difference delta p data between the left ventricle and the aorta according to the data such as the current I, the rotating speed omega and the like.
The following provides a specific embodiment of a current-pressure difference-rotational speed model:
the pressure difference is deltap, the current is I, and the rotating speed is omega. The current-pressure difference-rotational speed relationship can be described as:
Δp＝f 1 (ω)×I+f 2 (ω)
(1)
Wherein f 1 (ω)＝4.7e -17 ×ω 4 -7.2e 12 ×ω 3 ；
f 2 (ω)＝-3.6e -14 ×ω 4 +5.5e 23 ×ω 3
As an example, the hydrodynamic total pressure satisfies equation (2), where p is the static pressure,for dynamic pressure, ρgz is gravitational potential energy. The static pressure is irrelevant to the speed, the dynamic pressure is relevant to the speed, the dynamic pressure can be influenced by different blood flow directions, vortex flows and the like, fluctuation or inaccuracy is easy to generate, in the embodiment, the gravitational potential energy of the catheter pump 1 is set to be zero, the total aortic pressure AO meets the formula (3), the pressure sensor 50 is set to measure the pressure data of the aortic static pressure p, and the controller 3 can combine the data of current, rotating speed and the like and calculate the total aortic pressure AO according to the formula (3).
The controller 3 can calculate the left ventricular pressure LV of the patient through the total aortic pressure AO and the pressure difference delta p, and due to individual differences, the left ventricular pressure LV of the patient is different, and an operator can select corresponding current I and rotating speed omega parameters aiming at different patients, so that the heart gradually recovers normal functions under the auxiliary work of the catheter pump. According to the embodiment of the application, the left ventricular pressure LV is obtained through monitoring the current and the rotating speed parameters and calculating by using the controller 3, and then the current I and the rotating speed omega are reversely regulated and controlled by the left ventricular pressure LV, so that the intelligent control and the closed-loop feedback of the ventricular assist device are realized. Specifically, referring to fig. 10, for a data presentation graph of the total aortic pressure AO and the left ventricular pressure LV, the controller 3 acquires the related current I and the rotational speed ω data and finally outputs the graph of the total aortic pressure AO and the left ventricular pressure LV to the user interface, and the operator can make a judgment according to the data graph. In particular, the aortic total pressure AO and the left ventricular pressure LV are not limited to being represented in one map, and may be represented in two maps, respectively. In another embodiment, the map may also be transmitted to the operator computer interface via the controller 3.
Specifically, referring to fig. 4, the inlet tube 10 is provided with a spherical feature 101 near the distal end, an inlet 102, and the spherical feature 101 is used to guide blood so that the blood is smooth and free of accumulation, avoiding thrombus formation therein. The number of inlets 102 may be one or more, preferably 3-4, in this embodiment 4, which is easy to machine and ensures that the inlet area is in a reasonable range.
In the ventricular assist device of the present application, the inlet tube 10 is located at the most distal end of the ventricular assist device, the proximal end of the inlet tube 10 is fixedly connected to the distal end of the composite sleeve 20, the proximal end of the composite sleeve 20 is fixedly connected to the distal end of the motor assembly 30, the proximal end of the motor assembly 30 is fixedly connected to the distal end of the delivery catheter 40 until the delivery catheter 40 extends to the outside of the body to be connected to the optical fiber of the controller 3, and in this embodiment, the fixed connection may be any manner that can achieve accessory connection, such as welding, plugging, screwing, etc., without being limited thereto.
As an example, referring to fig. 5, the motor assembly 30 of the present embodiment includes an impeller 301, a pump housing 302, a motor 303, and a tail cap 304. The impeller 301 is accommodated in the pump casing 302, the pump casing is provided with an outlet 3023, the motor 303 is started, the motor 303 drives the impeller 301 to rotate, the impeller 301 rotates to suck blood, the blood flows through the spherical feature 101 and enters the catheter pump 1 from the inlet 102 of the inlet pipe 10, the blood is circumferentially diffused under the action of the rotating force when flowing through the impeller 301, the pump casing 302 rectifies the rotating blood, so that the blood flows through the impeller 301 along the axial direction and finally flows out from the outlet 3023 of the pump casing, and the purpose that the blood is transferred from the left ventricle of the heart to the aorta is achieved.
It should be specifically noted that, in the above embodiment, the pump housing outlet 3023 is disposed around the output side of the impeller 301, so that most of the structure of the impeller 301 is prevented from being exposed in the blood vessel, even the impeller 301 is completely exposed, and the blood flow does not start to spread around the starting portion of the impeller 301, so that the impact on the blood vessel is effectively reduced, and the loss of energy along the axial movement is avoided.
In one embodiment, the impeller 301 has an anticoagulant coating attached to its outer surface, which has a contamination-preventing function, and which conceals the medical device surface from the blood and is not prone to thrombus. The anticoagulation coating comprises an inert layer and an active layer coated outside the inert layer, wherein the inert layer is used for isolating the outer surface of the impeller 301 from blood, and the active layer is used for acquiring the coagulation factors, so that the anticoagulation coating can not only reduce the interaction between the coagulation factors in the blood and the surface of the catheter pump 1, but also inhibit the activation path of the coagulation factors and avoid the amplification of the coagulation factors.
In particular, as a medical device implanted in a human body, it is desirable to reduce the frictional resistance of the device in entering the human body as much as possible, so that in one embodiment, the surface of the composite sleeve 20 is coated with a hydrophilic coating having a low friction coefficient and a smooth surface, so that the catheter pump 1 can more easily pass through the aortic arch, and when passing through a blood vessel, reduce the friction with the inner wall of the blood vessel, improve the delivery efficiency, and make it reach the left ventricular site more quickly.
In particular, referring to fig. 9, the pressure sensor 50 includes a flow guide 501 at a distal tip, a first slot 502, and a chip 503. The diversion portion 501 is configured to have a hemispherical structure, and is used for diversion of blood, so that the blood can smoothly transition when flowing through the distal end of the pressure sensor 50, thereby avoiding thrombosis and accumulation. The blood flows through the flow guiding portion 501 and enters the first slot 502, the first slot 502 is arranged adjacent to the proximal end of the flow guiding portion 501, the first slot 502 penetrates through the distal end of the pressure sensor 50, the width of the first slot can be designed to be 0.1-0.2mm, and the length of the first slot can be designed to be 1-3mm. The first slots 502 may be 1-4 in design, and preferably 3 in this embodiment. The holding chamber has been seted up at the distal end main part that is close to the proximal end of first fluting 502, and the chip sets up in the holding intracavity, and the chip distal end leaves one section space apart from the proximal end of first fluting 502, and there is great impact force in blood after getting into first fluting 502, has the distance of buffering in order to let blood get into behind this space in order to prevent that blood impact force is too big, leads to the pressure test inaccuracy of chip 503. The pressure of blood flowing in through the first slot 502 is perceived by the chip 503 as the aortic static pressure p.
The proximal end of the pressure sensor 50 is connected with the optical fiber of the controller 3, the proximal main body of the pressure sensor 50 is accommodated in the delivery catheter 40, and the tail cover 304 is provided with a third slot 3041 for enabling the proximal main body of the pressure sensor 50 to extend out of the delivery catheter 40 and attach to the outer surface of the motor until extending distally to the outer surface of the pump shell 302.
The tail cap 304 of the motor assembly is a flared hollow structure including a distal end face and a proximal end face, and a third slot 3041 starts from the distal end face of the tail cap 304 and extends to the body (not continuing to the proximal end face) of the tail cap 304. The third slot 3041 may be rectangular or oval in shape or other structures that allow the pressure sensor 50 to pass through, without limitation. The width of the third slot 3041 is not particularly limited, and the width of the third slot 3041 is set to 1mm in this embodiment.
In this embodiment, the delivery catheter 40 is a hollow tube having a distal end fixedly connected to the tail cap 304 of the motor assembly 30, and the tube extends proximally until it extends outside the body and is in optical fiber connection with the controller 3. The pressure sensor 50 comprises a proximal head end, a proximal body, a distal body and a distal head end, wherein the distal head end of the pressure sensor 50 is arranged in a hemispherical structure, the proximal body and the distal body are arranged in a cylindrical structure, the diameter of the body ranges from 0.2mm to 1mm, and preferably, the diameter of the body of the pressure sensor 50 is 0.4mm. The proximal end of the pressure sensor 50 is connected with the optical fiber of the controller 3, the proximal end main body is accommodated in the conveying conduit 40 and extends to the tail cover 304 along the body of the conveying conduit 40, a third slot 3041 is formed in the tail cover 304, when the body of the conveying conduit 40 extends to the third slot 3041, the proximal end main body of the pressure sensor 50 penetrates out of the third slot 3041 and then extends to the outer surface of the motor 303 after penetrating out of the third slot 3041, the motor 303 is provided with a second slot 3031, and the distal end main body of the pressure sensor 50 extends to the pump shell 302 after being attached to the second slot 3031; the distal end is attached to the outer surface of the pump casing 302, the pump casing 302 is provided with an extension groove, the extension groove comprises a guide head end 3022, the distal end of the pressure sensor 50 is accommodated in the extension groove, and the guide part 501 of the distal end is matched with the guide head end 3022 in shape.
In particular, the pressure sensor 50 is configured in a cylindrical structure having a hemispherical shape at one end, and the second slot 3031 may be configured as a rectangle, an ellipse, or the like, and the embodiment is configured as a 1/2 cylinder, which may be formed by punching. The second slot 3031 has a cross-sectional diameter of 0.4mm. The main body half of the pressure sensor 50 is clamped into the second slot 3031, and the other half is arranged to protrude from the motor 303. The fixing of the pressure sensor 50 and the second slot 3031 can be performed by glue bonding, hot melting or welding, and the application selects a laser welding mode to weld the sensor on the surface of the second slot 3031. In particular, the welding may be selected from a whole welding, two ends in the axial direction of the motor 303, or a plurality of spot welds, which are not particularly limited herein.
In this embodiment, the elongated slot further includes an elongated slot main body 3021, and the elongated slot main body 3021 may be configured as a rectangle, an ellipse, or the like, and in this embodiment, the second slot is configured as a 1/2 cylinder. The cross-sectional diameter of the extension tank main body 3021 was designed to be 0.4mm. The pressure sensor 50 has one half of its body snapped into the elongate channel body 3021 and the other half protruding from the pump housing 302. The distal end of the pressure sensor 50 has a deflector portion that is compatible with the deflector head end 3022 of the elongated slot and the distal body of the pressure sensor 50 is compatible with the elongated slot body 3021 and the second slot 3031.
As an example, the sealing system 2 is connected distally to the catheter pump and proximally to the controller 3. The sealing system 2 provides flushing fluid for the catheter pump 1, and the controller 3 can drive the catheter pump 1 to be started and closed, and can control the flushing fluid flow of the sealing system 2 so as to prevent coagulation in the working process of the catheter pump 1.
The working principle of the ventricular assist device of the application is explained as follows: the ventricular assist device enters the heart and the aorta of a human body through interventional operation, the inlet tube 10 is positioned in the left ventricle, a part of the composite sleeve 20 is positioned in the aorta, the motor component 30 is started, the impeller 301 rotates and draws left ventricular blood, the blood enters the conduit pump through the inlet 102 of the inlet tube 10 and finally flows out of the pump shell outlet 3023, the pressure sensor positioned on the outer surface of the pump shell is used for detecting aortic static pressure p and transmitting data thereof to the controller 3, the controller 3 calculates the total aortic pressure AO according to the aortic static pressure p and current I and rotational speed omega data at the moment, and calculates the pressure difference delta p according to the total aortic pressure AO data and the pressure difference delta p data, an operator can calculate whether the cardiac index of the patient is in a normal state according to the data of the left ventricular pressure LV, and regulate and control the current I and rotational speed omega data by the controller 3, the corresponding left ventricular pressure index is returned to a normal range, intelligent control of the ventricular assist device is realized through the process, the current I and rotational speed omega data can be regulated and controlled by the ventricular assist device, and the ventricular feedback device can be realized.
The foregoing description is only of embodiments of the present application, and is not intended to limit the scope of the application, and all equivalent structures or equivalent processes using the descriptions and the drawings of the present application or directly or indirectly applied to other related technical fields are included in the scope of the present application.
Claims (10)
1. A ventricular assist device, comprising:
a catheter pump for implantation in a human heart, comprising a pressure sensor configured to measure aortic static pressure p in the heart and a motor assembly configured to provide a current I and a rotational speed ω;
the controller is used for adjusting the current I and the rotating speed omega and converting the current I and the rotating speed omega into pressure difference delta p data to be transmitted to a user interface of the controller, and the conversion equation of the pressure difference delta p data is as follows:
Δp＝f 1 (ω)×I+f 2 (ω)，
wherein f 1 (ω)＝4.7e -17 ×ω 4 -7.2e 12 ×ω 3 ，
f 2 (ω)＝-3.6e -14 ×ω 4 +5.5e 23 ×ω 3 ；
Receiving the aortic static pressure p from the pressure sensor and converting the aortic static pressure p into an aortic total pressure AO, wherein the conversion equation of the aortic total pressure AO is as follows:
and converting the data of the total aortic pressure AO and the pressure difference deltap into left ventricular pressure LV, wherein the controller correspondingly regulates and controls the current I and the rotating speed omega according to the left ventricular pressure LV, so as to realize closed loop feedback of the ventricular assist device.
2. The ventricular assist device of claim 1, wherein,
the pressure sensor comprises a flow guiding part positioned at the distal end head end, a first slot and a chip, wherein the flow guiding part is used for guiding blood and enabling the blood to enter the first slot, and the chip is used for sensing the pressure of the blood flowing in through the first slot and recording the pressure as the aortic static pressure.
3. The ventricular assist device of claim 2, wherein,
the pressure sensor comprises a far-end main body, wherein the far-end main body is close to the near end of the first slot, a containing cavity is formed in the far-end main body, the chip is arranged in the containing cavity, a gap is reserved between the far end of the chip and the near end of the first slot so as to buffer the impact force of blood flowing in through the first slot, and the far-end is one end far away from an operator.
4. The ventricular assist device of claim 3, wherein,
the motor assembly comprises a motor and a pump shell, wherein the motor is configured to provide current I and rotating speed omega, a second slot is formed in the outer surface of the motor and used for accommodating the pressure sensor far-end main body, an extension slot is formed in the outer surface of the pump shell and used for accommodating the pressure sensor far-end head end, and the extension slot comprises a flow guide head end and is used for being matched with the flow guide part of the pressure sensor.
5. The ventricular assist device of claim 4, wherein,
the catheter pump comprises a delivery catheter, the motor assembly comprises a tail cover, the delivery catheter is fixedly connected with the tail cover, the proximal end of the pressure sensor is connected with the controller through optical fibers, the proximal main body of the pressure sensor is accommodated in the delivery catheter, and a third slot is formed in the tail cover and used for enabling the proximal main body of the pressure sensor to extend out of the delivery catheter and enter the second slot.
6. The ventricular assist device of claim 4, wherein,
the motor assembly further comprises an impeller, and the impeller is accommodated in the pump shell; the pump shell is provided with an outlet, the outlet is arranged at the proximal end of the impeller, and the pump shell is used for rectifying blood and enabling the blood to flow out from the outlet at the proximal end of the impeller after flowing through the impeller so as to reduce the impact force of the blood on blood vessels.
7. The ventricular assist device of claim 6, wherein,
the catheter pump further comprises a tube and a composite sleeve, wherein the distal end of the composite sleeve is connected with the tube, the proximal end of the composite sleeve is fixedly connected with the motor assembly, the tube comprises an inlet, and the motor assembly drives the impeller to enable blood to enter the catheter pump from the inlet and flow out from the outlet of the pump shell.
8. The ventricular assist device of claim 1, further comprising a sealing system secured at a proximal end to the controller and at a distal end to the catheter pump, the sealing system for providing irrigation fluid to the catheter pump to prevent coagulation during operation of the catheter pump.
9. The ventricular assist device of claim 6, wherein the impeller surface is provided with an anticoagulant coating comprising an inert layer for isolating the impeller from the blood and an active layer coating the exterior of the inert layer.
10. The ventricular assist device of claim 7, wherein the outer surface of the composite sleeve is provided with a hydrophilic coating for reducing blood resistance of the ventricular assist device upon entry into a human body.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311068444.4A CN117100995A (en) | 2023-08-23 | 2023-08-23 | ventricular assist device |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311068444.4A CN117100995A (en) | 2023-08-23 | 2023-08-23 | ventricular assist device |
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| CN117100995A true CN117100995A (en) | 2023-11-24 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117717325A (en) * | 2024-02-18 | 2024-03-19 | 安徽通灵仿生科技有限公司 | Left ventricle pressure determining system and method based on ventricular catheter pump |
| CN117899349A (en) * | 2024-03-18 | 2024-04-19 | 生命盾医疗技术(苏州)有限公司 | Ventricular assist device control method and device, electronic equipment and storage medium |
-
2023
- 2023-08-23 CN CN202311068444.4A patent/CN117100995A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117717325A (en) * | 2024-02-18 | 2024-03-19 | 安徽通灵仿生科技有限公司 | Left ventricle pressure determining system and method based on ventricular catheter pump |
| CN117717325B (en) * | 2024-02-18 | 2024-05-14 | 安徽通灵仿生科技有限公司 | Left ventricle pressure determining system and method based on ventricular catheter pump |
| CN117899349A (en) * | 2024-03-18 | 2024-04-19 | 生命盾医疗技术(苏州)有限公司 | Ventricular assist device control method and device, electronic equipment and storage medium |
| CN117899349B (en) * | 2024-03-18 | 2024-06-04 | 生命盾医疗技术(苏州)有限公司 | Ventricular assist device control method and device, electronic equipment and storage medium |
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