CN116328173A - Monitoring catheter, monitoring system and method for assisting heart in pumping blood - Google Patents

Monitoring catheter, monitoring system and method for assisting heart in pumping blood Download PDF

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Publication number
CN116328173A
CN116328173A CN202310222850.5A CN202310222850A CN116328173A CN 116328173 A CN116328173 A CN 116328173A CN 202310222850 A CN202310222850 A CN 202310222850A CN 116328173 A CN116328173 A CN 116328173A
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China
Prior art keywords
monitoring
catheter
sensor
impeller
blood
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CN202310222850.5A
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Chinese (zh)
Inventor
李雨琦
高与番
郑李洋
胡登脉
李志刚
张坤
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Shanghai Weiqi Medical Instrument Co ltd
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Shanghai Weiqi Medical Instrument Co ltd
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Priority to CN202310222850.5A priority Critical patent/CN116328173A/en
Publication of CN116328173A publication Critical patent/CN116328173A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178Implantable 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/205Non-positive displacement blood pumps
    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/515Regulation using real-time patient data
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/515Regulation using real-time patient data
    • A61M60/523Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/515Regulation using real-time patient data
    • A61M60/531Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804Impellers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3327Measuring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3365Rotational speed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/125Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/30Blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2230/00Measuring parameters of the user
    • A61M2230/50Temperature
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02EREDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
    • Y02E10/00Energy generation through renewable energy sources
    • Y02E10/20Hydro energy

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

Abstract

In a monitoring catheter for assisting cardiac pumping, the improvement comprising: the inflow channel is a tubular body with a through hole on the pipe wall; the outflow channel is connected with the proximal end of the inflow channel and is a tubular body with a through hole on the tube wall; the impeller device is arranged in the outflow channel; the sensor is arranged on the impeller device; fluid enters from the inflow channel and flows out from the outflow channel through the impeller device; when the fluid flows out, the impeller device can release the rotation pressure generated by the fluid, so that the sensor can sense the detected information and output data information.

Description

Monitoring catheter, monitoring system and method for assisting heart in pumping blood
Technical Field
The invention relates to the technical field of medical equipment, in particular to a monitoring catheter, a monitoring system and a monitoring method for assisting heart pump blood.
Background
Heart failure is mainly due to heart contraction and relaxation dysfunction, which causes insufficient cardiac power of venous blood pumping and insufficient arterial blood perfusion, thereby causing abnormal heart blood circulation. Among them, left heart failure is particularly common. In the early stage of left heart failure treatment, medicines are generally adopted for treatment. When the symptoms of the later stage of the left heart failure are heavy, intervention is needed by implanting a pacemaker in a surgery. The left ventricular assist device is an effective means for relieving severe heart failure, and is implanted into the heart through the femoral artery, so that blood in the left ventricle can be pumped into the aorta to assist the left ventricle to complete blood circulation. With percutaneous mechanical circulatory support devices commonly used in clinic: such as intra-aortic balloon counterpulsation, etc. Compared with an external membrane oxygenator, the left ventricle auxiliary system catheter is simple to operate, low in risk and small in wound, and can complete operation to recover heart pumping in a short time. In most cardiac interventions, doppler ultrasound is a common method of detecting blood flow to calculate blood flow velocity by transmission and reception of ultrasound.
In the left ventricular assist system catheter pumping operation, specific blood flow and blood flow velocity can only be reflected by doppler ultrasound. The use of ultrasound to detect blood flow requires a skilled sonographer and can be operated multiple times to obtain more accurate results. When the catheter rotates abnormally or stops, the Doppler ultrasound cannot timely feed back the running state of the current catheter due to more blood flow interference when the heart pumps blood.
Disclosure of Invention
The application aims to solve the technical problems existing in the prior art. Therefore, the embodiment of the application provides a monitoring catheter, a monitoring system and a monitoring method for assisting heart in pumping blood, which can monitor blood flow change in the heart in real time through a monitoring device connected with the catheter of the heart assisting system, judge whether the catheter can pump blood normally, discover stalling caused by thrombus or other reasons such as service life caused by high-speed rotation of the catheter in time, and remarkably improve the safety and the accuracy of heart failure surgery.
In the present invention, a monitoring catheter for assisting in cardiac pumping, the improvement comprising:
the inflow channel is a tubular body with a through hole on the pipe wall;
the outflow channel is connected with the proximal end of the inflow channel and is a tubular body with a through hole on the pipe wall;
an impeller device disposed within the outflow channel;
the sensor is arranged on the impeller device;
fluid enters from the inflow channel and flows out of the outflow channel through the impeller device; when the fluid flows out, the impeller device can release the rotary pressure generated by the fluid, so that the sensor can sense the detected information and output the data information.
Preferably, the impeller device comprises:
the base is a cylinder;
the shaft core is coaxially arranged with the base;
the blade is arranged on the outer surface of the shaft core; the area of the circumcircle of the blade is smaller than the cross-sectional area of the base;
the outer wall of the impeller is an annular body; coaxially connected to the base;
and a notch for installing a sensor is arranged on the outer wall of the impeller.
Preferably, the blade includes a spiral sector formed on an outer surface of the shaft core by rotating in an axial direction.
Preferably, the monitoring catheter for assisting heart pump blood further comprises: and the connecting pipe is used for connecting the inflow channel and the outflow channel, and a developing ring is arranged on the connecting pipe.
Preferably, the connecting pipe is an elbow.
Preferably, the monitoring catheter further comprises: a connecting conduit, which is a tubular object, is connected to the proximal end of the impeller device.
Preferably, the connecting catheter includes:
the connecting catheter inner cavity is coaxially connected with the impeller device;
the reaming wire is arranged in the inner cavity of the connecting catheter;
the connecting catheter outer cavity is coaxially arranged with the connecting catheter inner cavity;
and the sensor wire is arranged in the pipe wall of the outer cavity of the connecting catheter and used for being connected with the sensor.
Preferably, the sensor includes: pressure sensor, temperature sensor, rotational speed sensor and flow sensor.
In a monitoring system for assisting cardiac pumping, the improvement comprising: a monitoring catheter for assisting heart pump blood;
a data receiving port connected with the proximal end of the connecting catheter for receiving signals;
and the monitoring device is electrically connected with the monitoring catheter for assisting the heart to pump blood and is used for monitoring information of signals. The application also relates to a monitoring method of auxiliary cardiac pumping, which is used for the monitoring system of auxiliary cardiac pumping, and the improvement is that the monitoring method comprises the following steps: placing the monitoring catheter for assisting the heart to pump blood into the left ventricle through the femoral artery by a guide wire; before the impeller device is started, the monitoring device obtains a monitoring data threshold value; when the impeller device is started, the monitoring device obtains actual monitoring data; comparing the actual monitoring data with a monitoring data threshold value, and judging that the monitoring catheter is in an abnormal working state when the actual monitoring data is not in the range of the monitoring data threshold value; and when the actual monitoring data fluctuates within the range of the monitoring data threshold value, judging that the monitoring catheter is in a normal working state.
Compared with the prior art, the invention has the beneficial effects that:
the monitoring catheter for the auxiliary heart pump blood has the advantages of simple structure, convenient operation, safety and high efficiency, and can realize real-time monitoring of blood flow and blood pressure in the pumping work without additional means and judging the running state of the catheter especially when the pressure monitoring based on the auxiliary heart pump blood is carried out.
The monitoring catheter and the monitoring system for assisting the heart to pump blood can monitor blood flow change in the heart in real time, judge whether the catheter can pump blood normally, discover stalling caused by thrombus or other reasons such as service life caused by high-speed rotation of the catheter in time, and obviously improve the safety and the accuracy of heart failure surgery; the pressure sensor can be replaced by a temperature sensor, a rotating speed sensor, a flow sensor and the like, and the pressure sensor can be used for different tissue parts of a human body in different implementation scenes including but not limited to heart, blood vessels, intestinal tracts, pulmonary veins, pulmonary arteries and the like.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention. Wherein:
FIG. 1 is a schematic view of a monitoring catheter according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a monitoring system according to an embodiment of the present invention;
FIG. 3 is a schematic view of an inflow channel according to an embodiment of the present invention;
FIG. 4 is a schematic front view of an inflow channel according to an embodiment of the present invention;
FIG. 5 is a schematic view of an outflow channel according to an embodiment of the invention;
FIG. 6 is a schematic front view of an outflow channel according to an embodiment of the invention;
FIG. 7 is a schematic left-hand view of an outflow channel according to an embodiment of the invention;
FIG. 8 is a schematic view of an impeller according to an embodiment of the present invention;
FIG. 9 is a schematic front view of an impeller according to an embodiment of the present invention;
FIG. 10 is a schematic left-hand view of an impeller in accordance with one embodiment of the present invention;
FIG. 11 is a schematic view of an impeller assembly according to an embodiment of the present invention;
FIG. 12 is a schematic left-hand view of an impeller assembly according to one embodiment of the present invention;
FIG. 13 is a schematic view of a connecting conduit according to one embodiment of the present invention;
the inflow channel 10, the transvalve elbow 20, the developing ring 21, the outflow channel 30, the shaft core 31, the sensor 32, the impeller device 33, the connecting catheter 40, the connecting catheter outer cavity 41, the sensor wire 42, the connecting catheter inner cavity 43, the hinge wire 44, the monitor 50, the catheter front section 60, the data receiving port 70 and the hose 80.
Detailed Description
The following description of the technical solutions in the embodiments of the present invention will be clear and complete, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the invention, fall within the scope of protection of the invention.
In the description of the present invention, the terms "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", etc. refer to the orientation or positional relationship based on that shown in the drawings, merely for convenience of description of the present invention and do not require that the present invention must be constructed and operated in a specific orientation, and thus should not be construed as limiting the present invention. The terms "coupled" and "connected" as used herein are to be construed broadly and may be, for example, fixedly coupled or detachably coupled; either directly or indirectly through intermediate components, the specific meaning of the terms being understood by those of ordinary skill in the art as the case may be.
In the field of interventional medical devices, the end of the medical device implanted in the human or animal body that is closer to the operator is generally referred to as the "proximal end", the end that is farther from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined in accordance with this principle. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle.
The invention will be described in detail below with reference to the drawings in connection with embodiments. It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other.
Heart failure is mainly due to heart contraction and relaxation dysfunction, which causes insufficient cardiac power of venous blood pumping and insufficient arterial blood perfusion, thereby causing abnormal heart blood circulation. Among them, left heart failure is particularly common. In the early stage of left heart failure treatment, medicines are generally adopted for treatment. When the symptoms of the later stage of the left heart failure are heavy, the intervention is needed by surgical implantation of a pacemaker or heart transplantation, however, the supply of the heart transplantation is insufficient, and the requirements of patients cannot be met. Therefore, a left ventricular assist device is generally adopted as an effective means for relieving severe heart failure, and is implanted into the heart through the femoral artery, so that blood in the left ventricle can be pumped into the aorta to assist the left ventricle to complete blood circulation. With percutaneous mechanical circulatory support devices commonly used in clinic: for example, compared with an intra-aortic balloon counterpulsation and an external membrane oxygenator, the left ventricular assist system catheter has the advantages of simple operation, low risk and small wound, and can complete operation and recover cardiac pumping in a short time. In most cardiac interventions, doppler ultrasound is a common method of detecting blood flow to calculate blood flow velocity by transmission and reception of ultrasound.
In the left ventricular assist system catheter pumping operation, specific blood flow and blood flow velocity can only be reflected by doppler ultrasound. The use of ultrasound to detect blood flow requires a skilled sonographer and can be operated multiple times to obtain more accurate results. When the catheter rotates abnormally or stops, the Doppler ultrasound cannot timely feed back the running state of the current catheter due to more blood flow interference when the heart pumps blood.
The existing heart pump blood auxiliary catheter does not have the capability of monitoring the working blood pressure of pump blood in real time. The existing Doppler ultrasound technology for testing blood flow and blood flow velocity requires the support of a professional ultrasound team, and has the disadvantages of complex operation, long training period and inaccurate test result. Therefore, the monitoring catheter for assisting heart pump blood has the advantages of simple structure, convenience in operation, safety and high efficiency, and can realize real-time monitoring of blood flow and blood pressure in pumping work without additional means and judging the running state of the catheter when pressure monitoring based on assisting heart pump blood is carried out. The device can monitor blood flow change in the heart in real time, judge whether the catheter pumps blood normally, discover in time that thrombus or other reasons such as life cause are caused by high-speed rotation of the catheter, and obviously improve the safety and the accuracy of heart failure surgery.
In particular, as shown in fig. 1, the present invention relates to a monitoring catheter for assisting cardiac pumping, which is improved in that the monitoring catheter for assisting cardiac pumping comprises an inflow channel 10, a transvalve elbow 20, an outflow channel 30 and a connecting catheter 40 which are connected in sequence.
Specifically, the inflow channel 10 is a tubular body, the length of which is not limited; comprises a first pipe wall and a first through hole arranged on the first pipe wall so as to facilitate the inflow of fluid.
Specifically, the shape and size of the first through hole are not limited, and the first through hole can be round, oval, polygonal or irregular, and only needs to penetrate through the pipe wall to form the through hole; the number of the first through holes is not limited, and one or more than one can be used, so that the function of allowing the fluid to enter the inflow channel can be achieved.
Preferably, as shown in fig. 3 and 4, in a preferred embodiment of the present application, in order to increase the blood flow entering through the inflow channel 10, the through holes are designed as rectangular notches extending along the axial direction of the tubular body, and the notches are uniformly arranged on the first tube wall. Preferably, the width edge of the rectangular notch can be adjusted to be arc-shaped, so that the notch is more round and does not hurt the vessel wall.
Meanwhile, in order to facilitate placement of the monitoring catheter in the blood vessel without damaging the wall of the blood vessel, a chamfer is provided at the distal end face of the inflow channel 10. The distal port of the inflow channel 10 is preferably designed to be smaller than its proximal port to further facilitate monitoring of catheter placement.
As shown in fig. 1, in some embodiments, a flexible and naturally curved hose 80 is attached to the distal end of the inflow channel 10. In order to avoid injury to the tissue and organ, the distal end of the flexible tube 80 is made of a flexible material, and the distal end is curled in a natural state, generally adopts a hollow tubular structure, and the monitoring catheter is assisted into a human body, such as a left ventricle of the heart by a guide wire, etc., so that the curled shape of the monitoring catheter is not folded, twisted or slipped in the left ventricle under the normal condition.
An outflow channel 30, which is a tubular body of unlimited length, is connected to the proximal end of the inflow channel 10; comprises a second pipe wall and a second through hole arranged on the second pipe wall so as to facilitate the outflow of blood;
specifically, the shape and size of the second through hole are not limited, and the second through hole can be circular, elliptical, polygonal or irregular, and only the second through hole is formed by penetrating through the wall of the second pipe; the number of the second through holes is not limited, and one or more than one can be used, so that blood can flow out of the outflow channel.
Preferably, as shown in fig. 5 to 7, in a preferred embodiment of the present application, in order to increase the flow of blood exiting from the outflow channel 30 and to avoid the subsequent disturbance of the operation state of the sensor due to an excessive flow of blood, rectangular through holes are provided in the middle of the outflow channel 30 along the axial direction of the tubular body, and the plurality of through holes are uniformly arranged on the second tube wall. In order to smooth the surface of the outflow channel 30, the rectangular through holes should be provided with rounded corners. To facilitate connection of the outflow channel 30 to other devices, the distal port of the outflow channel 30 is smaller than the proximal port thereof.
Impeller means 33 coaxially arranged within said outflow channel;
the impeller device includes: the blade comprises a base, a blade and a shaft core. Specifically, the shape of the shaft core is not limited, and may be regarded as a rotation shaft coaxially provided with the outflow channel 30, and may be a columnar body. In a preferred embodiment of the present application, as shown in fig. 8 to 10, the mandrel is a strip, and the cross section of the mandrel is a three-star structure, specifically, it is assumed that a whole circle is divided into three parts by three rays starting at the center of the circle on average, and the three-star structure is a strip structure formed by extending the three rays along the axis. The shape of the blades is not limited either, and the blades may be a plurality of uniformly arranged fan-shaped blades, preferably 2-4 blades, arranged along the radial direction of the surface of the shaft core, and the blades may be coplanar in the radial direction or may be arranged separately along the axial direction, so long as the rotational pressure applied to blood by the impeller device can be released.
The blades rotate around the axial direction of the shaft core on the outer surface of the shaft core to form a spiral sector, and when the shaft core rotates, the blades can be driven to rotate together so as to release the rotary pressure exerted by the impeller device on blood. Specifically, the blade may be a spiral sector formed by rotating a single blade, or may be a sector formed by rotating a plurality of blades. In one of the preferred embodiments of the present application, two blades extend axially from different initial positions along the same rotation direction on the surface of the shaft core, and since the shaft core has a three-pointed star structure, the blades and the shaft core exhibit a relatively clamping effect, so that the connection between the blades and the shaft core is firmer.
The impeller device further comprises an impeller outer wall,
specifically, the outer wall of the impeller is a tubular body and is coaxially connected to the other end of the base, namely, the impeller is arranged in the direction opposite to the direction of the blades. The diameter of the outer wall of the impeller is matched to the diameter of the base to ensure that the impeller assembly can be placed into the outflow channel 30. A notch is also provided in the outer wall of the impeller to receive the sensor. Preferably, in order to obtain better sensing data, the outer wall of the impeller is the same as the size of the base, so that the sensor is more sensitive to the external environment when in use, and more accurate detection data can be obtained. The setting position and the number of the sensors are not limited, so that the sensors are uniformly arranged on the outer wall of the impeller for more accurate detection.
The motor is arranged in a hollow part formed by the outer wall of the impeller and is connected with the shaft core to provide power for the impeller device.
As shown in fig. 11 and 12, when the outflow channel 30 is assembled with the impeller device, it is necessary to ensure that the sensor is located in the outer wall of the impeller, and the second through hole of the outflow channel 30 is radially matched with the vane, so that when blood flows out, the sensor cannot be interfered by the blood, and various data of the blood flowing out can be monitored.
As shown in fig. 13, the monitoring catheter further comprises a connecting catheter 40 connected to the proximal end of the impeller device 33, and is composed of a connecting catheter outer lumen 41, a sensor wire 42, a connecting catheter inner lumen 43 and a hinge wire 44.
The connecting catheter comprises a connecting catheter inner cavity 43, is a strip hollow hose, is not limited in material, and is coaxially connected with a shaft core;
a wire hinge 44, preferably a wire twisted along its own axis, is disposed in the connecting conduit lumen 43 and connected to the impeller means with a motor for transmitting electrical energy;
the connecting catheter outer cavity 41 is a long hose, is not limited in material, and is coaxially arranged with the connecting catheter inner cavity 43;
the sensor wire 42 is used to connect with the sensor 32, and the setting position is not limited. In the preferred embodiment of the present application, the sensor wire 42 is placed in the tube wall of the outer lumen 41 of the connecting catheter in the axial direction of the outer lumen 41.
In order to achieve the effect of enabling the monitoring catheter to smoothly enter the left chamber of the heart, a connecting pipe is further arranged at the joint of the inflow channel and the outflow channel. And the connecting tube is designed to be curved, i.e. as a flap-spanning elbow 20. The curvature is not limited and is used for matching the curvature of the left ventricle and the femoral artery.
In order to be able to show the specific position of the monitoring catheter in the aortic arch of the heart, a visualization ring 21 is also provided on the second connection tube.
The monitoring catheter provided by the invention can use different sensors so as to be applied to different monitoring environments.
One of the implementation scenarios:
as shown in fig. 1 and 2, when the sensor is a pressure sensor, a monitoring catheter according to the present invention includes: inflow channel 10, transvalve elbow 20, developing ring 21, impeller device 33, pressure sensor, outflow channel 30, and connecting conduit 40. The inflow channel 10 is arranged at the distal end of the monitoring catheter and is connected with the transvalve elbow 20; the developing ring 21 is disposed at the rear end of the valve-crossing elbow 20, and is used for X-ray penetration to display the specific position of the developing ring on the valve-crossing elbow in the aortic arch, and record the pressure monitoring data output by the monitor 50 at this time. The transvalve elbow 20 is connected with the outflow channel 30 and is connected with the inflow channel 10 to form a catheter front section 60, namely the inflow channel 10, the transvalve elbow 20 and the outflow channel 30 which are sequentially connected from the distal end to the proximal end form the catheter front section 60. The catheter tip 60 needs to be threaded from the inflow channel 10 to the outflow channel 30 by a guide wire. The guide wire is inserted into the left ventricle through the femoral artery, and the catheter front section 60 is inserted into the left ventricle through the guide wire to pump blood. Impeller means 33 are provided in the outflow channel 30; the inner wall of the outflow channel 30 is provided with more than three equally distributed pressure sensors for monitoring the blood pressure of the pump in real time, namely the blood pressure when the blood flows out of the outflow channel 30, and taking the average value of the data to reduce the test error. The outflow channel 30 is connected to the connecting conduit 40; the connecting catheter comprises a connecting catheter outer lumen 41 and a connecting catheter inner lumen 43. A catheter outer lumen 41 is connected for positioning a sensor wire 42. The sensor wire 42 is connected to the monitoring data receiving port 70 at the proximal end of the connecting catheter 40, and is connected to the external monitor 50 through the data receiving port, so as to display the real-time blood pressure value during the pumping operation. A connecting conduit lumen 43 for the provision of a hinge wire 44 for connection to the impeller means. The hinge wire is also connected to a motor provided at the proximal end of the connecting catheter 40, and the hinge wire is driven by the motor to rotate the impeller device 33, so as to assist the pumping of the left ventricular blood into the aorta, and record the output data of the pressure monitor after the pumping is stabilized. The connecting catheter lumen 43 is used for injecting physiological saline and heparin, wherein the physiological saline is used for discharging bubbles in the connecting catheter before an operation and reducing the working temperature of the impeller device, and the heparin is used for preventing postoperative complications caused by local thrombus. After the blood is pumped, the actual pressure data monitored by the monitor 50 is compared with the monitoring data threshold value of the impeller device before the blood is pumped, and when the pressure monitoring data obviously fluctuates and exceeds the monitoring data threshold value, namely the safety value of the impeller device during operation, the operation state of the impeller device in the guide pipe needs to be judged. If the impeller device rotates abnormally, the catheter should be withdrawn in time for replacement, so that the normal operation of auxiliary pumping blood is ensured. Because the impeller device adopted by the monitoring conduit has different structures, the corresponding pump blood flow is different, and the generated pressure is different, the monitoring range is not unified at present, and the running state of the impeller device can be checked only by monitoring and detecting that larger fluctuation occurs.
This application sets up pressure sensor and impeller device as an organic wholely, when using, pressure sensor can be more acutely felt blood and act on the lateral pressure of outflow passageway when flowing, can obtain more accurate blood pressure monitoring data to whether and then the heart auxiliary pump blood pipe is at normal work rapidly.
And the second application scene is as follows:
when the sensor employs a temperature sensor, the blood temperature at the time of pumping blood can be measured. The monitoring catheter placement mode is the same as the application scene one, and redundant description is not needed. After pumping, the real-time temperature value during pumping operation is displayed by the monitor 50. The temperature monitoring data threshold, namely the normal range of the heart temperature of the human body, is 36.9 degrees to 37.9 degrees, the temperature data before blood pumping is recorded, and the temperature data is compared with the temperature data actually monitored after blood pumping to judge whether the blood temperature in the heart is normal or not. If the real-time temperature is higher than 37.9 degrees continuously after the catheter is stably operated for 10min, the pumping of blood needs to be stopped in time.
This application sets up temperature sensor and impeller device as an organic wholely, and when using, temperature sensor can be more acutely experienced human heart temperature, can obtain more accurate temperature monitoring data to whether and then the heart assist pump blood pipe is at normal work rapidly.
And III, application scene:
when the sensor is a rotational speed sensor, the rotational speed of the impeller device at the time of pumping blood can be measured. The monitoring catheter placement mode is the same as the application scene one, and redundant description is not needed. The real-time rotational speed of the impeller during pumping operation of the impeller is displayed by the monitor 50. And recording the real-time rotating speed of the impeller device, comparing the real-time rotating speed with a monitoring data threshold value, namely the actual rotating speed of the motor, and judging the running state of the impeller device in the guide pipe. If the rotating speed of the impeller device is abnormal, the actually monitored rotating speed data is not matched with the actual rotating speed of the motor, and the guide tube is withdrawn in time for replacement, so that the normal operation of auxiliary pumping blood is ensured.
The rotational speed sensor and the impeller device are arranged into a whole, and when the device is used, the rotational speed sensor can obtain the rotational speed data of the impeller device more accurately so as to quickly respond to whether the heart auxiliary pump blood conduit is working normally or not.
Fourth, application scene:
when the sensor is a flow sensor, the blood flow rate at the time of pumping blood can be measured. The catheter placement mode is the same as the application scene one, and redundant description is not needed. The real-time flow of the pumped blood from the impeller device during the pumping operation is displayed by the monitor 50. The monitoring device obtains actual monitoring data, records the real-time flow of blood during blood pumping, compares the real-time flow with the monitoring data threshold before blood pumping, and judges whether the impeller device in the catheter pumps blood normally. If the pump blood flow is abnormal, judging that the monitoring catheter is in an abnormal working state, and timely withdrawing the catheter for replacement to ensure the normal operation of auxiliary pump blood. Specifically, assuming that the human heart pump blood flow X L/min is recorded before the impeller device rotates, if the maximum pump blood flow of the impeller device is 2.0-2.5L/min (excluding the human heart pump blood flow), the pump blood flow is recorded as 2.Y L/min, and the pump blood flow threshold value of normal operation is X+2.Y L/min. When the actual monitoring data after blood pumping has larger fluctuation, namely the monitoring flow suddenly drops to about X L/min from the initial flow X+2.Y L/min, the impeller device can be regarded as stopping rotating at the moment, and the catheter should be replaced in time.
This application sets up flow sensor and impeller device as an organic wholely, when using, flow sensor can more acutely receive the blood flow of blood outflow passageway to can obtain more accurate flow monitoring data, so that whether the supplementary pump catheter of heart is in normal work of rapid response in turn.
The foregoing description of the preferred embodiments of the invention is not intended to limit the invention to the particular embodiments disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Claims (10)

1. A monitoring catheter for assisting cardiac pumping, the monitoring catheter comprising:
the inflow channel is a tubular body with a through hole on the pipe wall;
the outflow channel is connected with the proximal end of the inflow channel and is a tubular body with a through hole on the pipe wall;
an impeller device disposed within the outflow channel;
the sensor is arranged on the impeller device;
fluid enters from the inflow channel and flows out of the outflow channel through the impeller device; when the fluid flows out, the impeller device can release the rotary pressure generated by the fluid, so that the sensor can sense the detected information and output the data information.
2. The cardiac pump assisted monitoring catheter of claim 1, wherein the impeller means comprises: the base is a cylinder;
the shaft core is coaxially arranged with the base;
the blade is arranged on the outer surface of the shaft core; the area of the circumcircle of the blade is smaller than the cross-sectional area of the base;
the outer wall of the impeller is an annular body; coaxially connected to the base;
and a notch for installing a sensor is arranged on the outer wall of the impeller.
3. The cardiac pumping-assist monitoring catheter as recited in claim 2 in which the blade comprises a spiral sector formed by axial rotation on an outer surface of the hub.
4. The cardiac assist pump monitoring catheter of claim 1, further comprising: and the connecting pipe is used for connecting the inflow channel and the outflow channel, and a developing ring is arranged on the connecting pipe.
5. The cardiac pump assisted monitoring catheter of claim 4, wherein the connecting tube is an elbow.
6. The monitoring catheter for assisting cardiac pumping according to claim 1, further comprising, in the monitoring catheter: a connecting conduit, which is a tubular object, is connected to the proximal end of the impeller device.
7. The cardiac pump assisted monitoring catheter of claim 6, wherein the connecting catheter comprises:
the connecting catheter inner cavity is coaxially connected with the impeller device;
the reaming wire is arranged in the inner cavity of the connecting catheter;
the connecting catheter outer cavity is coaxially arranged with the connecting catheter inner cavity;
and the sensor wire is arranged in the pipe wall of the outer cavity of the connecting catheter and used for being connected with the sensor.
8. A monitoring catheter for assisting cardiac pumping according to claim 3, wherein the sensor comprises: pressure sensor, temperature sensor, rotational speed sensor and flow sensor.
9. A monitoring system for assisting cardiac pumping, the monitoring system comprising: a monitoring catheter for assisting cardiac pumping according to any one of claims 1-8;
a data receiving port connected with the proximal end of the connecting catheter for receiving signals;
and the monitoring device is electrically connected with the monitoring catheter for assisting the heart to pump blood and is used for monitoring information of signals.
10. A method of monitoring assisted heart pumping, for use in a system for monitoring assisted heart pumping as in claim 9, the method comprising: placing the monitoring catheter for assisting the heart to pump blood into the left ventricle through the femoral artery by a guide wire; before the impeller device is started, the monitoring device obtains a monitoring data threshold value; when the impeller device is started, the monitoring device obtains actual monitoring data; comparing the actual monitoring data with a monitoring data threshold value, and judging that the monitoring catheter is in an abnormal working state when the actual monitoring data is not in the range of the monitoring data threshold value; and when the actual monitoring data fluctuates within the range of the monitoring data threshold value, judging that the monitoring catheter is in a normal working state.
CN202310222850.5A 2023-03-09 2023-03-09 Monitoring catheter, monitoring system and method for assisting heart in pumping blood Pending CN116328173A (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180250456A1 (en) * 2017-03-02 2018-09-06 White Swell Medical Ltd Systems and methods for reducing pressure at an outflow of a duct
CN110237327A (en) * 2019-06-14 2019-09-17 湖南埃普特医疗器械有限公司 A kind of external profile shaft stream ventricular assist device of driving
CN111437449A (en) * 2020-05-06 2020-07-24 广州弘大医疗科技有限公司 Right heart auxiliary device
CN111632217A (en) * 2020-05-15 2020-09-08 孙英贤 Ventricular circulation auxiliary device with middle impeller
CN114984444A (en) * 2022-05-24 2022-09-02 苏州心岭迈德医疗科技有限公司 Catheter intervention heart pump
US20230001180A1 (en) * 2021-06-30 2023-01-05 Abiomed, Inc. Systems and methods of deriving pressures external to an intracardiac blood pump using internal pressure sensors

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180250456A1 (en) * 2017-03-02 2018-09-06 White Swell Medical Ltd Systems and methods for reducing pressure at an outflow of a duct
CN110237327A (en) * 2019-06-14 2019-09-17 湖南埃普特医疗器械有限公司 A kind of external profile shaft stream ventricular assist device of driving
CN111437449A (en) * 2020-05-06 2020-07-24 广州弘大医疗科技有限公司 Right heart auxiliary device
CN111632217A (en) * 2020-05-15 2020-09-08 孙英贤 Ventricular circulation auxiliary device with middle impeller
US20230001180A1 (en) * 2021-06-30 2023-01-05 Abiomed, Inc. Systems and methods of deriving pressures external to an intracardiac blood pump using internal pressure sensors
CN114984444A (en) * 2022-05-24 2022-09-02 苏州心岭迈德医疗科技有限公司 Catheter intervention heart pump

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