WO2023226779A1 - Pompe cardiaque à intervention par cathéter - Google Patents

Pompe cardiaque à intervention par cathéter Download PDF

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Publication number
WO2023226779A1
WO2023226779A1 PCT/CN2023/093576 CN2023093576W WO2023226779A1 WO 2023226779 A1 WO2023226779 A1 WO 2023226779A1 CN 2023093576 W CN2023093576 W CN 2023093576W WO 2023226779 A1 WO2023226779 A1 WO 2023226779A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
drainage tube
heart pump
pressure sensor
tube
Prior art date
Application number
PCT/CN2023/093576
Other languages
English (en)
Chinese (zh)
Inventor
柯浩
闫小珅
Original Assignee
苏州心岭迈德医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 苏州心岭迈德医疗科技有限公司 filed Critical 苏州心岭迈德医疗科技有限公司
Publication of WO2023226779A1 publication Critical patent/WO2023226779A1/fr

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Classifications

    • 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
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • 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
    • 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

Definitions

  • This specification relates to the field of medical devices, and in particular to a catheter interventional heart pump.
  • interventional devices such as coronary balloons, stents, etc.
  • PCI percutaneous coronary intervention
  • interventional devices may aggravate the degree of myocardial ischemia and affect the pumping function of the ventricle, causing the patient's Insufficient cardiac output, in turn, leads to insufficient oxygen-rich blood perfusion in the coronary arteries, further aggravating myocardial ischemia, making the operation more difficult, and even leading to cardiac shock and death of the patient during the operation.
  • Catheter interventional heart pumps are usually used for hemodynamic maintenance, which can reduce the load on the ventricles, increase the blood input of the coronary arteries, thereby improving the myocardial ischemia state, allowing patients to obtain more complete revascularization during PCI surgery. and more thorough treatment.
  • a catheter interventional heart pump which includes a drainage tube, an impeller, a driving motor and a catheter; the drainage tube is provided with a fluid inlet at its front end, and a fluid outlet is provided at its rear end.
  • At least one section of the spring tube includes a spring tube, which is in a curved shape in a natural state; the impeller is arranged in the drainage tube, and the drive motor is used to drive the impeller to rotate, and the drive motor includes a stator side and an output Rotating shaft, the output rotating shaft is fixedly connected to the impeller, the front end on the stator side is fixedly connected to the rear end of the drainage tube, and the rear end on the stator side is fixedly connected to the front end of the conduit.
  • the front end of the drainage tube is connected to a pigtail catheter
  • the front end of the pigtail catheter is made of flexible material
  • the front end of the pigtail catheter is curled in a natural state.
  • the drainage tube is provided with a development ring, and the development ring is disposed at a curved portion of the drainage tube.
  • the catheter interventional heart pump further includes a reducer tube, a suture pad and a sterile protective bag; the reducer tube, the suture pad and the sterile protective bag are connected in sequence and set on the Outside the conduit, the diameter of the reducing tube gradually increases from the front end of the reducing tube to the rear end of the reducing tube.
  • the taper of the reducing tube is 5° to 30°.
  • adjusting nuts are provided at both ends of the sterile protective bag, and the adjusting nuts can lock the two ends of the sterile protective bag with the catheter respectively.
  • the catheter interventional heart pump further includes a controller configured to control the drive motor to drive the impeller to rotate.
  • the catheter interventional heart pump further includes a first pressure sensor and/or a second pressure sensor; the first pressure sensor is disposed at the front end of the drainage tube; the second pressure sensor is disposed at the The rear end of the drainage tube.
  • the first pressure sensor is positioned closer to the heart pump relative to the fluid inlet. Front end; the second pressure sensor is disposed closer to the front end of the heart pump relative to the fluid outlet.
  • the controller is configured to determine the position of the drainage tube in the body according to the first pressure signal of the first pressure sensor and/or the second pressure signal of the second pressure sensor.
  • the controller is configured to: determine a first position of the drainage tube according to the first pressure signal; determine a second position of the drainage tube according to the second pressure signal; The first position and the second position determine the position of the drainage tube within the body.
  • the catheter interventional heart pump further includes a rectifying device, the rectifying device is sleeved on the output shaft of the driving motor through a bearing, and the rectifying device is in contact with the stator of the driving motor. Side fixed connection.
  • the catheter-intervention heart pump further includes an extracorporeal positive pressure infusion device capable of applying positive pressure to the gap between the rectifying device and the drive motor through the catheter. Instill sealing fluid.
  • the sealing liquid passes through the inside of the driving motor; the surface of the driving motor in contact with the sealing liquid is provided with a parylene coating.
  • Figure 1 is a schematic structural diagram of a catheter-involved heart pump according to some embodiments of this specification
  • Figure 2 is a partially exploded schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification
  • Figure 3 is a schematic structural diagram of a rectifier device according to some embodiments of this specification.
  • Figure 4 is a schematic structural diagram of a rectifier device according to other embodiments of this specification.
  • Figure 5 is a partial cross-sectional view of a catheter-interposed heart pump according to some embodiments of the present specification
  • Figure 6 is a partial cross-sectional view of a catheter-interposed heart pump according to other embodiments of this specification.
  • Figure 7 is a schematic structural diagram of a pigtail catheter according to some embodiments of this specification.
  • Figure 8 is a schematic structural diagram of a pigtail catheter according to other embodiments of this specification.
  • Figure 9 is a schematic structural diagram of a drainage tube according to some embodiments of this specification.
  • Figure 10 is a partial structural schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification.
  • Figure 11 is a schematic diagram of the overall structure of a catheter-intervened heart pump according to some embodiments of this specification.
  • Figure 12 is a partial structural schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification.
  • Figure 13 is an exemplary structural schematic diagram of a controller according to some embodiments of this specification.
  • the reference numbers are: 10. Catheter interventional heart pump; 100. Drainage tube; 110. Fluid inlet; 120. Fluid outlet; 130. Spring tube; 140. Development ring; 150. Inlet halter; 160. Outlet halter; 200 , impeller; 300, drive motor; 310, rectifier; 311, core; 312, via hole; 313, small end; 314, big end; 315, blade; 316, mounting part; C, central symmetry axis; 320, Output shaft; 330, first seal; 340, second seal; 350, bearing; 360, sealing fluid; 400, conduit; 500, pigtail conduit; 510, first straight section; 520, curved section; 530, third Two straight sections; 600, reducer; 700, suture pad; 800, sterile protective bag; 810, adjusting nut; 900, controller; 910, first pressure sensor; 920, second pressure sensor; 930, storage Media; 940, processor.
  • the catheter-intervention heart pump in the embodiment of this specification may be a pumping device introduced into a heart failure patient and maintaining blood power in the heart.
  • Catheter-involved heart pumps can be used for revascularization in cardiogenic shock due to various causes. Cardiogenic shock refers to heart pumping dysfunction, which can lead to extremely critical situations such as organ failure due to low perfusion pressure in various organs.
  • the catheter-involved heart pump can be punctured into the aorta through the femoral artery or axillary artery, and then retrograde along the aorta, through the aortic arch, through the aortic valve and into the left ventricle. After accurate positioning, the catheter can be started to intervene in the heart.
  • the pump can pump the oxygen-rich blood from the left ventricle to the ascending aorta, thereby stabilizing the patient's hemodynamics in the short term, reducing the load on the ventricle to restore myocardial and ventricular functions, and increasing the arterial blood perfusion of various organs to avoid various organ factors. Insufficient blood supply may lead to functional abnormalities or even irreversible damage.
  • the catheter-intervention heart pump in the embodiments of this specification can also be used in other organs or blood vessels, such as the right ventricle, renal artery, cerebral blood vessels, etc. This specification does not limit this.
  • Figure 1 is a schematic structural diagram of a catheter-involved heart pump according to some embodiments of this specification.
  • Figure 2 is a partially exploded schematic diagram of a catheter-interposed heart pump according to some embodiments of the present specification.
  • the catheter-intervention heart pump 10 includes a drainage tube 100 , an impeller 200 , a driving motor 300 and a catheter 400 .
  • the drainage tube 100 can be a tube that guides the blood flow path.
  • the drainage tube 100 is provided with a fluid inlet 110 at the front end, and the fluid outlet 120 is provided at the rear end of the drainage tube 100. Blood flows into the drainage tube 100 from the fluid inlet 110, from Fluid outlet 120 exits drain tube 100 .
  • the front end of the drainage tube 100 refers to the end that enters the human body first during the operation, and the rear end of the drainage tube 100 refers to the end that enters the human body later during the operation.
  • the diameter of the drainage tube 100 may be in the range of 4 mm to 7 mm (such as 4 mm, 5 mm, 5.5 mm, 6 mm, 7 mm, etc.).
  • an inlet trap 150 is provided at the fluid inlet 110.
  • the inlet trap 150 is in the shape of a grid, which can prevent heart tissue (such as mitral valve chordae tendineae) from being sucked into the drainage tube 100, and prevent the ventricular wall from being blocked due to negative pressure. Blocking the blood flow inlet causes the drive motor 300 to be overloaded.
  • the inlet trap 150 may be made of metal material or polymer material.
  • an outlet trap 160 is provided at the fluid outlet 120 . At least part of the outlet trap 160 is in the shape of a grid, which can adjust the direction in which blood flows out of the fluid outlet 120 .
  • the outlet trap 160 can be integrally formed with the drainage tube 100 , that is, multiple cutouts are made on the side wall of the rear end of the drainage tube 100 to form the outlet trap 160 .
  • the outlet trap 160 can be a component independent of the drainage tube 100 and is fixed to the rear end of the drainage tube 100 by snapping, welding, bonding, or other means.
  • the outlet trap 160 can be made of metal material or polymer material.
  • At least one section of the drainage tube 100 includes a spring tube 130.
  • the spring tube 130 is in a curved shape in a natural state.
  • the spring tube 130 will elastically deform under the action of an external force. After the external force disappears, the elastic restoring force will return to its natural state.
  • the drainage tube 100 may entirely include a spring tube 130, and the inner and/or outer walls of the spring tube 130 may be provided with a polymer material layer.
  • portions of drainage tube 100 include spring tube 130 .
  • a certain middle section of the drainage tube 100 includes a spring tube 130 , and the spring tube 130 constitutes a bent portion of the drainage tube 100 .
  • the drainage tube 100 may also include but is not limited to polymer braided tubes, hypotubes, etc.; the scaffold material of the drainage tube 100 may be nickel-titanium alloy.
  • the impeller 200 of the catheter-involved heart pump 10 is disposed in the drainage tube 100 for regulating the flow rate of the catheter-involved heart pump 10 .
  • the impeller 200 includes spiral blades arranged around its rotation axis. When the impeller 200 rotates, the spiral blades can drive the fluid in the draft tube 100 to increase in speed and gyration pressure, thereby increasing the flow rate of the fluid in the draft tube 100 .
  • the fluid outlet 120 outputs fluid with a higher flow rate and pressure to form a pressure difference between the fluid inlet 110 and the fluid outlet 120, thereby increasing the perfusion flow of the heart.
  • the impeller 200 may be made of metal materials (such as stainless steel, titanium alloy, cobalt-chromium alloy, etc.) or polymer materials (such as polyetheretherketone PEEK). In some embodiments, the impeller 200 can be manufactured by metal machining or polymer material injection molding.
  • the driving motor 300 is used to drive the impeller 200 to rotate.
  • the drive motor 300 includes a stator side and an output shaft 320.
  • the stator side may be a stationary component of the drive motor 300, such as a stator core, a stator winding, a frame, etc.
  • the output shaft 320 may be a shaft that can rotate relative to the stator side.
  • the output shaft 320 is fixedly connected to the impeller 200 , the front end on the stator side is fixedly connected to the rear end of the drainage tube 100 , and the rear end on the stator side is fixedly connected to the front end of the conduit 400 .
  • the front end in the embodiment of this specification refers to the end that enters the human body first during the operation, and the rear end refers to the end that enters the human body later during the operation.
  • the output shaft 320 drives the impeller 200 to rotate, causing the fluid in the drainage tube 100 to rotate with the impeller 200 to generate a gyrating pressure, so that the blood perfusion pressure at the fluid outlet 120 is relative to the pressure at the fluid inlet 110 Increased blood perfusion pressure.
  • the catheter-involved heart pump 10 may further include a rectifying device 310 , which is disposed at the fluid outlet 120 for adjusting the fluid pattern at the fluid outlet 120 .
  • the rectifier device 310 is sleeved outside the output shaft 320 of the drive motor 300 and is fixedly connected to the stator side of the drive motor 300 , that is, the rectifier device 310 remains relatively stationary relative to the stator side, and the output shaft 320 passes through the rectifier.
  • Device 310 is connected to impeller 200 .
  • the rectifying device 310 can buffer the impact force of the fluid and guide the direction of fluid flow.
  • the rectifying device 310 can adjust the rotational flow pattern or the turbulent flow pattern of the fluid. It is a flow pattern along the axis of the blood vessel, thereby releasing the gyration pressure of the fluid and reducing the impact of the fluid on the blood vessel. See Figures 3 and 4 and their associated descriptions for more details about the rectification device 310.
  • the catheter-interposed heart pump 10 in the above embodiment, it can be inserted into organs such as the heart or blood vessels, and the impeller 200 pressurizes the heart or blood vessels to increase the perfusion pressure of the organs such as the heart or blood vessels, thereby increasing the pumping function of the heart and reducing the burden on the heart.
  • the drainage tube 100 has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the drainage tube 100 to guide the blood flow of the left ventricle into the aorta.
  • Figure 3 is a schematic structural diagram of a rectifier device according to some embodiments of this specification.
  • Figure 4 is a schematic structural diagram of a rectifier device according to other embodiments of this specification.
  • the rectifying device 310 includes a core 311 , which is configured as a centrally symmetrical block.
  • the centrally symmetrical block means that the core 311 can be rotated at any angle around the central symmetry axis C and can be aligned with itself. Overlapping block structures.
  • the core 311 includes a small end 313 and a large end 314, and the cross-section from the small end 313 to the large end 314 gradually increases.
  • the cross section from the small end 313 to the large end 314 can increase linearly. For example, as shown in FIG.
  • the core 311 is configured in a truncated cone shape, with the small end 313 at the top of the truncated cone and the large end 314 at the bottom of the truncated cone.
  • the cross section from the small end 313 to the large end 314 can increase non-linearly.
  • the core 311 is configured as a hemisphere, the top of the hemisphere is set as the small end 313 , and the bottom of the hemisphere is set as is big endian 314.
  • the small end 313 is disposed close to the impeller 200 and the large end 314 is disposed close to the drive motor 300 .
  • the core 311 is also provided with a mounting portion 316 for fixing to the stator side of the drive motor 300 .
  • the mounting portion 316 is configured as a cylinder, the mounting portion 316 is disposed at the large end 314 and the axis of the mounting portion 316 is co-linearly arranged with the central symmetry axis C of the core 311 .
  • the cross-section of the mounting portion 316 is smaller than the cross-section of the large end 314 .
  • the cross-section of the mounting portion 316 is equal to the cross-section of the large end 314 .
  • the mounting portion 316 is fixed to the stator side of the drive motor 300, and various fixing methods such as laser welding, bonding, and threaded connection can be used, which are not limited in this specification.
  • the core 311 is provided with a through hole 312 for avoiding the output rotating shaft 320 , and the through hole 312 extends from the small end 313 to the large end 314 along the central axis of symmetry C.
  • the diameter of the through hole 312 of the core 311 is larger than the diameter of the output shaft 320 of the drive motor 300 .
  • the rectification device 310 further includes a plurality of blades 315 , which are spacedly arranged on the outer surface of the core 311 around the central symmetry axis C of the core 311 , and are used for releasing The swirling pressure exerted by the impeller 200 on the blood.
  • the blades 315 When the fluid in the rotating flow state or the turbulent flow state impacts the rectifying device 310, the blades 315 have a diversion effect on the fluid, thereby changing and adjusting the flow direction of the fluid to achieve the purpose of releasing its swirling pressure.
  • the number of blades 315 can be set as needed.
  • the number of blades 315 can be two, three, or four, etc., which is not limited in this specification.
  • the angles formed by adjacent blades 315 and the central axis of symmetry C may be equal, that is, the blades 315 may be arranged around the core 311 at equally spaced angles relative to the central axis of symmetry C. In some embodiments, the angles formed by adjacent blades 315 with the central axis of symmetry C may be unequal.
  • the blades 315 may be arranged in a swirling shape on the outer surface of the core 311 , and the rotation direction of the blades 315 may be opposite to the rotation direction of the blades of the impeller 200 , thereby better counteracting the swirling pressure of the fluid.
  • the blades 315 can be arranged in an arc shape on the outer surface of the core 311 , and the blades 315 can have a larger radius of curvature to improve the rectification effect.
  • the blades 315 can be arranged in a straight line on the outer surface of the core 311 , that is, the blades 315 extend straight from the small end 313 of the core 311 to the large end 314 of the core 311 , thereby adjusting the flow through the rectifying device 310
  • the fluid can continue to flow in the direction of the central symmetry axis C of the rectifying device 310 .
  • the rectifying device 310 may not be provided with blades 315 , but directly utilize the surface curvature of the core 311 to buffer the impact force of the fluid and perform a rectifying effect.
  • the rectifying device 310 can be injection molded from plastic material to reduce the overall weight of the catheter-involved heart pump.
  • the rectifying device 310 can be machined from metal materials.
  • metal materials include but are not limited to cobalt-chromium alloys, stainless steel materials, etc.
  • the rectifying device 310 made of metal has high strength and long service life.
  • Figure 5 is a partial cross-sectional view of a catheter-involved heart pump according to some embodiments of the present specification.
  • a seal is provided between the rectifying device 310 and the drive motor 300 .
  • the seal is used to prevent blood from infiltrating into the drive motor 300 and causing the drive motor 300 to cause rust, leakage, short circuit and other failures.
  • the number of seals may be determined according to the structure and sealing level of the drive motor 300 .
  • the seal includes a first seal 330 and a second seal 340 that assist each other to increase the sealing performance of the drive motor 300 .
  • the first seal 330 is disposed between the rectifying device 310 and the output rotating shaft 320 of the driving motor 300 to prevent blood from infiltrating into the driving motor 300 from the gap between the rectifying device 310 and the output rotating shaft 320 .
  • the first seal 330 is configured as an annular structure, an accommodation cavity is formed inside the rectifying device 310 , the first seal 330 is disposed in the accommodation cavity and is in sliding contact with the output shaft 320 , so that the first seal The component 330 can block the gap between the output rotating shaft 320 and the rectifying device 310 .
  • the first seal 330 may be made of polytetrafluoroethylene (Teflon or PTFE), so that the first seal 330 has the advantages of sealing performance, high lubrication and non-stickiness, and the high lubrication of the first seal 330
  • Teflon or PTFE polytetrafluoroethylene
  • the non-stickiness makes the friction force of the output rotating shaft 320 when it is in sliding contact with the output rotating shaft 320 very small, and the loss of the output rotating shaft 320 is very small.
  • the second seal 340 is disposed between the rectifying device 310 and the stator side of the driving motor 300 to prevent blood from infiltrating into the driving motor 300 from the installation gap between the rectifying device 310 and the stator side.
  • the second seal 340 is configured in a disc shape.
  • the disc-shaped second seal 340 includes a flat bottom plate and a protrusion formed along the edge of the flat bottom plate.
  • the flat bottom plate blocks the stator side of the drive motor 300
  • the protrusions block the connection between the mounting part 316 of the rectification device 310 and the stator side, thereby improving the sealing performance of the connection.
  • the second seal 340 may be made of materials such as medical rubber, medical silicone, or polytetrafluoroethylene, which is not limited in this specification.
  • medical silicone grease can be coated between the seal and the rectifying device 310 and between the seal and the driving motor 300.
  • the medical silicone grease plays a role in lubrication and sealing. For example, it can reduce the size of the first seal. The friction force between the component 330 and the output shaft 320.
  • Figure 6 is a partial cross-sectional view of a catheter-interposed heart pump according to other embodiments of the present specification.
  • the rectifying device 310 can be sleeved on the output shaft 320 of the drive motor 300 through the bearing 350.
  • the arrangement of the bearing 350 can make the output shaft 320 rotate more smoothly inside the rectifying device 310, thereby improving the driving force of the output shaft 320. Stability of impeller 200 rotation.
  • the bearing 350 may be disposed between the fairing device 310 and the output shaft 320 .
  • the inner ring of the bearing 350 may be fixedly connected to the output shaft 320
  • the outer ring of the bearing 350 may be fixedly connected to the inner wall of the rectifying device 310 .
  • a second seal 340 may be disposed between the rectifying device 310 and the stator side of the driving motor 300 to improve the sealing between the rectifying device 310 and the stator side of the driving motor 300 . See Figure 5 and its associated description for more details on the second seal 340.
  • the rectifying device 310 and the driving motor 300 can be sealed by a sealing liquid 360, where the sealing liquid 360 includes but is not limited to physiological saline, glucose solution, etc.
  • the catheter-intervention heart pump further includes an extracorporeal positive pressure infusion device (not shown in the figure).
  • the extracorporeal positive pressure infusion device can apply positive pressure to the gap between the rectifying device 310 and the drive motor 300 through the catheter 400 Instill sealing fluid.
  • sealing fluid may pass through the interior of the drive motor 300 .
  • the arrows in Figure 6 illustrate the flow path of the sealing liquid 360: the sealing liquid 360 is instilled through extracorporeal positive pressure and introduced from the catheter 400 into the driving motor 300.
  • the housing it then flows from between the second seal 340 and the stator side of the drive motor 300 to the output shaft 320 , flows along the outer wall of the output shaft 320 and the rectifying device 310 to the outside of the bearing 350 , and flows from the bearing 350 to the rectifying device 310 continues to flow between the outer wall of the output shaft 320 and the rectifying device 310, and flows outward toward the organ at the position where the impeller 200 and the rectifying device 310 are butted.
  • the gap between the rectifying device 310 and the driving motor 300 is filled with the sealing liquid 360, which can adapt to gaps of different sizes and has a good sealing effect.
  • the surface of the driving motor 300 that is in contact with the sealing liquid is provided with parylene coating.
  • a parylene coating may be provided on the surface of the drive motor 300 before assembling the catheter interventional heart pump.
  • the disassembled drive motor can be soaked in a parylene solution, so that the stator side and the output shaft of the drive motor are both covered with parylene coating.
  • the parylene coating can also be replaced by other biocompatible material coatings, which is not limited in this specification.
  • the extracorporeal positive pressure infusion device can be implemented by a peristaltic pump or gravity.
  • the infusion pressure can be in the range of 150 to 600mmHg, such as 200mmHg, 350mmHg, 400mmHg, 500mmHg, etc.
  • Figure 7 is a schematic structural diagram of a pigtail catheter according to some embodiments of this specification.
  • Figure 8 is a schematic structural diagram of a pigtail catheter according to other embodiments of this specification.
  • a pigtail catheter 500 is connected to the front end of the drainage tube 100.
  • the front end of the pigtail catheter 500 is made of flexible material to avoid damage to tissues and organs.
  • the front end of the pigtail catheter 500 is curled in a natural state, and is used to assist the drainage tube 100, the driving motor 300 and other structures to enter the heart (such as entering the left ventricle), and its curled shape is not easy to fold in the left ventricle. , twisting and slipping.
  • the pigtail catheter 500 may be a hollow tubular structure that is guided into the left ventricle through a guidewire or the like.
  • the pigtail catheter 500 may be a solid soft structure, for example, made of materials such as thermoplastic urethane elastomer (Thermoplastic Urethane, TPU), polyether block polyamide, or the like.
  • the pigtail catheter 500 includes a first straight section 510 and a curved section 520.
  • the rear end of the first straight section 510 is connected to the front end of the drainage tube 100, and the front end of the first straight section 510 is connected to the front end of the drainage tube 100.
  • the curved sections 520 are connected, and the curved section 520 is curved in an arc from the front end of the first straight section 510 toward the rear end.
  • the pigtail catheter 500 includes a first straight section 510 , a second straight section 530 and a curved section 520 .
  • the rear end of the first straight section 510 is connected to the front end of the drainage tube 100 .
  • the front end of the straight section 510 is connected to the rear end of the second straight section 530
  • the front end of the second straight section 530 is connected to the curved section 520
  • the curved section 520 is curved in an arc from the front end of the second straight section 530 toward the rear end.
  • the angle between the first straight line segment 510 and the second straight line segment 530 is greater than 90° and less than 180°.
  • Figure 9 is a schematic structural diagram of a drainage tube according to some embodiments of this specification.
  • the drainage tube 100 is provided with a developing ring 140.
  • the developing ring 140 is disposed at a curved portion of the drainage tube 100.
  • the developing ring 140 can be developed in an imaging device (such as an X-ray imaging device). , used to position and mark the position of the drainage tube 100 in the human body.
  • the developing ring 140 may be made of metallic materials, such as tantalum, platinum-iridium alloy, etc.
  • the developing ring 140 may be disposed in a non-bent portion of the drainage tube 100 .
  • a plurality of developing rings 140 may be provided on the drainage tube 100 to more accurately display the position and posture of the drainage tube 100 in the human body.
  • Figure 10 is a partial structural diagram of a catheter-interposed heart pump according to some embodiments of this specification.
  • the catheter interventional heart pump 10 may further include a reducing tube 600 , a suture pad 700 and a sterile protective bag 800 .
  • the reducing tube 600 , the suture pad 700 and the sterile protective bag 800 are connected in sequence and sheathed outside the catheter 400 .
  • the diameter of the reducing tube 600 gradually increases from the front end of the reducing tube 600 to the rear end of the reducing tube 600 .
  • the reducing tube 600 can be used to stop bleeding at the opening of the blood vessel.
  • the taper of the reducing tube 600 is 5° ⁇ 30°, for example, the taper is 5°, 10°, 15°, 18°, 20°, 25°, 30°, etc.
  • the taper of the reducing tube 600 is too large, it will easily cause damage to the opening of the blood vessel, while if the taper is too small, it will be difficult to achieve a hemostatic effect.
  • By setting the taper of the reducing tube 600 in the range of 5° to 30° It can not only avoid damaging the opening of blood vessels, but also has a good hemostatic effect.
  • the diameter of the entire reducing tube 600 gradually and continuously increases from the front end to the rear end, making the reducing tube 600 a tapered pipe.
  • the diameter of the reducing tube 600 may increase in a stepwise manner from the front end to the rear end.
  • the front end section, the middle section and the rear end section of the reducing pipe 600 are all equal diameter pipes.
  • the diameter of the front end section is smaller than the diameter of the middle section, and the diameter of the middle section is smaller than the rear end section. The diameter of the section.
  • the suture pad 700 may be used to suture tissue (eg, skin tissue at the opening of a blood vessel) to limit movement of the catheter-involved heart pump 10 within the body.
  • suture tissue eg, skin tissue at the opening of a blood vessel
  • the sterile protective bag 800 is placed on the catheter 400 to prevent the catheter 400 from being contaminated by bacteria during use or recovery, thereby reducing the risk of surgical infection.
  • the sterile protective bag 800 can move axially along the catheter 400.
  • adjusting nuts 810 are provided at both ends of the sterile protective bag 800. The adjusting nuts 810 can lock the two ends of the sterile protective bag 800 with the catheter 400, thereby limiting the relative contact between the sterile protective bag 800 and the catheter. 400 axial displacement.
  • the adjusting nuts 810 at both ends of the sterile protective bag 800 can be locked to prevent wound infection caused by instrument withdrawal.
  • an outer sheath is used to pass through the catheter 400 exposed outside the body and on the pump body during instrument retrieval, and the catheter 400 outside the body can be protected from infection by providing a sterile protective bag 800 .
  • Figure 11 is a schematic diagram of the overall structure of a catheter-involved heart pump according to some embodiments of this specification.
  • Figure 12 is a partial structural schematic diagram of a catheter-involved heart pump according to some embodiments of this specification.
  • the catheter interventional heart pump 10 further includes a controller 900 , and the controller 900 can be used to control the drive motor 300 to drive the impeller 200 to rotate.
  • the controller 900 may send control instructions to the drive motor 300 based on artificially set control parameters.
  • the controller 900 can automatically determine the control parameters and send control instructions to the drive motor 300, thereby avoiding interference from human factors.
  • the control parameters may include, but are not limited to, voltage, current, driving speed, power of the driving motor 300, pressure signals collected by sensors, etc.
  • the controller 900 is arranged outside the body and is connected to the driving motor 300 via a signal signal.
  • a part of the cable can pass through the catheter 400 into the body and be connected to the driving motor 300, and the other part is located outside the body and connected to the controller 900.
  • the controller 900 can be powered by its own battery, or the controller 900 can be powered by a power source from the grid.
  • the catheter interventional heart pump 10 further includes a first pressure sensor 910 and/or a second pressure sensor 920; the first pressure sensor 910 and the second pressure sensor 920 include but are not limited to piezoelectric sensors. Pressure sensor, piezoresistive pressure transmitter sensors, electromagnetic pressure sensors, capacitive pressure sensors, etc.
  • the catheter-intervention heart pump 10 may include only one pressure sensor, that is, the first pressure sensor 910 or the second pressure sensor 920 .
  • the catheter-intervention heart pump 10 may include two pressure sensors, ie, a first pressure sensor 910 and a second pressure sensor 920 .
  • the working status of the catheter-involved heart pump 10 can be easily learned, so that the performance and clinical effect of the catheter-involved heart pump 10 can be monitored, and the catheter can be guided accordingly. Interventional heart pump 10 works better.
  • the first pressure sensor 910 is disposed at the front end of the drainage tube 100, and the first pressure sensor 910 can be used to detect the blood perfusion pressure at the front end of the drainage tube 100. In some embodiments, if the drainage tube 100 is inserted into the left ventricle, the first pressure sensor 910 is used to detect the blood perfusion pressure in the left ventricle; if the drainage tube 100 is inserted into the aorta, the first pressure sensor 910 is used to detect blood perfusion pressure in the left ventricle. To detect the perfusion pressure in the aorta.
  • the first pressure sensor 910 is disposed closer to the front end of the heart pump (the catheter is inserted into the heart pump 10) relative to the fluid inlet 110 (as shown in FIG. 12), so that the first pressure sensor 910 can detect the presence of blood in the heart pump 10.
  • the blood perfusion pressure before entering the fluid inlet 110 may be 20 to 60 mm (such as 20 mm, 30 mm, 50 mm, 60 mm, etc.).
  • the first pressure sensor 910 is disposed closer to the rear end of the heart pump relative to the fluid inlet 110 and is disposed close to the fluid inlet 110 . At this time, the first pressure sensor 910 can detect the blood perfusion pressure at the fluid inlet 110 .
  • the second pressure sensor 920 is disposed at the rear end of the drainage tube 100, and the second pressure sensor 920 can be used to detect the blood perfusion pressure at the rear end of the drainage tube 100.
  • the blood perfusion pressure at the rear end of the drainage tube 100 may be the blood pressure after the blood is pressurized through the drainage tube 100, the impeller 200 and other components.
  • the second pressure sensor 920 is disposed closer to the front end of the heart pump relative to the fluid outlet 120 (as shown in FIG. 12 ). Since a turbulent flow area may appear at the fluid outlet 120 and affect the detection accuracy of the second pressure sensor 920, disposing the second pressure sensor 920 at the front end of the fluid outlet 120 can avoid the influence of turbulent flow at the fluid outlet 120 and improve the detection accuracy of the second pressure sensor 920. The second pressure sensor 920 detects the accuracy. In some embodiments, the distance between the second pressure sensor 920 and the fluid outlet 120 may be 30-70 mm (such as 30 mm, 40 mm, 50 mm, 70 mm, etc.). In some embodiments, as shown in FIG. 12 , the second pressure sensor 920 may be disposed on the outer surface of the outlet trap 160 .
  • the second pressure sensor 920 may be positioned closer to the rear end of the heart pump relative to the fluid outlet 120 .
  • the second pressure sensor 920 and the fluid outlet 120 can be separated by a preset distance range (such as 3cm, 5cm, etc.), so that the second pressure sensor 920 can avoid the turbulent flow area and improve the data collected by the second pressure sensor 920. Accuracy of data.
  • the controller 900 is configured to determine the position of the drainage tube 100 in the body according to the first pressure signal of the first pressure sensor 910 and/or the second pressure signal of the second pressure sensor 920 . Since the blood perfusion pressures of different organs and parts of the human body are different, such as the left ventricle, aorta, veins, etc., the drainage can be determined through the pressure signals detected by the first pressure sensor 910 and the second pressure sensor 920 The position of tube 100 in the body. In some embodiments, the position of the drainage tube 100 in the body can be represented by the position of any point on the drainage tube 100 in the body. In some embodiments, the position of the drainage tube 100 within the body may be represented by the position of the imaging ring 140 on the drainage tube 100 within the body.
  • the first pressure sensor 910 and the second pressure sensor 920 can determine the specific location of the drainage tube 100 in a certain organ or part of the body.
  • the first pressure sensor 910 enters the left ventricle with the heart pump, and different positions in the left ventricle The device has different pressures, and the specific position of the first pressure sensor 910 in the left ventricle can be determined according to the pressure value detected by the first pressure sensor 910; thus, the drainage can be further deduced according to the position of the first pressure sensor 910 on the drainage tube 100.
  • the specific location of tube 100 within the body is a certain organ or part of the body.
  • the first pressure sensor 910 and the second pressure sensor 920 may also be used to determine changes in the position of the drainage tube 100 within the body. For example, if the pressure value of the first pressure sensor 910 changes significantly in a short period of time (for example, the change rate of the pressure value exceeds a set threshold), it indicates that the drainage tube 100 may suddenly move in the body, such as suddenly falling off from the left ventricle to the aorta. , at this time, the controller 900 can generate early warning information to alert the operator.
  • the controller 900 may determine the position of the drainage tube 100 within the body based solely on the first pressure signal of the first pressure sensor 910 . In some embodiments, the controller 900 may determine the position of the drainage tube 100 within the body based solely on the second pressure signal of the second pressure sensor 920 . In some embodiments, the controller 900 may simultaneously determine the position of the drainage tube 100 in the body based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920 to improve the accuracy of position determination.
  • the controller 900 (such as the processor 940) can obtain the pre-stored correspondence between the position information and the pressure value from the storage medium (such as the storage medium 930). For example, the controller 900 may obtain pre-stored pressure values corresponding to different positions in the patient's left ventricle, pressure values corresponding to different positions in the aorta, and pressure values corresponding to different positions in the veins.
  • the controller 900 may pre-collect position information and its corresponding pressure value through the developing ring 140 .
  • the catheter-intervened heart pump 10 can be implanted into the human body and imaged by an imaging device to obtain position information of the imaging ring 140 .
  • the position of the imaging ring 140 imaged under the imaging device can be collected in real time or periodically, and the first pressure sensor of the developing ring 140 at different positions can be simultaneously recorded. a pressure signal and/or a second pressure signal from a second pressure sensor.
  • the corresponding relationship between the position information and the pressure value may be a one-to-one correspondence between the position and the pressure value, or it may be a functional relationship between the position and the pressure value obtained through a fitting algorithm.
  • the position information of the left ventricle may be represented by spatial three-dimensional coordinates.
  • the center point of the aortic valve is used as the coordinate origin, the left-right direction of the human body is the three-dimensional coordinates.
  • the location information of the detection point in the aorta may be represented by the distance between the detection point and the aortic valve.
  • the controller 900 may determine that the drainage tube 100 is in the body according to the first pressure signal of the first pressure sensor 910 and/or the second pressure signal of the second pressure sensor 920 s position. In some embodiments, the controller 900 can jointly determine the position of the drainage tube 100 in the body based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920. Specific steps include:
  • Step 1 Determine the first position of the drainage tube 100 according to the first pressure signal.
  • the first pressure sensor 910 can acquire the first pressure signal and feed it back to the controller 900.
  • the controller 900 can compare the first pressure signal with a pre-stored pressure value and obtain a comparison result. If the difference between the value of the first pressure signal and the pre-stored pressure value is within a preset range (for example, the difference is 0-5% of the pre-stored pressure value), then the first pressure sensor 910 can be roughly determined is at the position corresponding to the pre-stored pressure value. According to this position, the position of the drainage tube 100 can be determined. First position.
  • the controller 900 may further calculate the precise position of the first pressure sensor 910 based on the difference between the value of the first pressure signal and the pre-stored pressure value. For example, the controller 900 can establish a functional relationship between position and pressure based on pressure values at different locations, and calculate the precise position of the first pressure sensor 910 through the functional relationship, and the first position of the drainage tube 100 can be determined based on the position.
  • Step 2 Determine the second position of the drainage tube 100 according to the second pressure signal.
  • the second pressure sensor 920 can acquire the second pressure signal and feed it back to the controller 900.
  • the controller 900 compares the second pressure signal with a pre-stored pressure value and obtains a comparison result. If the difference between the value of the second pressure signal and the pre-stored pressure value is within a preset range (for example, the difference is 0-5% of the pre-stored pressure value), the second pressure sensor 920 can be roughly determined. is at a position corresponding to the pre-stored pressure value, and the second position of the drainage tube 100 can be determined based on this position.
  • the controller 900 may further calculate the precise position of the second pressure sensor 920 based on the difference between the value of the second pressure signal and the pre-stored pressure value. For example, the controller 900 can establish a functional relationship between position and pressure based on pressure values at different locations, and calculate the precise position of the second pressure sensor 920 through the functional relationship, and the second position of the drainage tube 100 can be determined based on the position.
  • Step 3 Determine the position of the drainage tube 100 in the body based on the first position and the second position.
  • both the first position and the second position represent the position of the drainage tube 100 in the body, and the controller 900 can select the first position or the second position as the position of the drainage tube 100 in the body. For example, if the difference between the first position and the second position is within a preset range (for example, the difference is less than 5 mm), it means that the error between the first position and the second position is small, and the controller 900 can use the first position as the drainage tube. 100 in the body, or the second position is used as the position of the drainage tube 100 in the body.
  • a preset range for example, the difference is less than 5 mm
  • the controller 900 can take an intermediate position between the first position and the second position, and determine the intermediate position as the position of the drainage tube 100 in the body, thereby effectively improving the position determination accuracy of the drainage tube 100 .
  • the position of the drainage tube 100 after the position of the drainage tube 100 is determined in the above manner, it can be determined based on the position whether the catheter-intervention heart pump 10 is installed at the position required for treatment. For example, it can be determined whether the front end of the drainage tube 100 is installed in the left ventricle or a specific position in the left ventricle (such as the apex position of the left ventricle). In some embodiments, by determining the position of the drainage tube 100 during the operation of the heart pump, it can be determined whether the position of the heart pump deviates during the operation. If the position of the heart pump deviates, there may be a possibility that the catheter may be inserted into the heart pump 10 from the left side unexpectedly. In case of ventricular detachment and other situations, the controller 900 can send out early warning information in time, thereby reducing the user's risk.
  • the controller 900 may also adjust the current output value, voltage output value and/or power output value of the driving motor 300 based on the signals of the first pressure sensor 910 and the second pressure sensor 920 .
  • the controller 900 can calculate and obtain control parameters based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920 , and send a control instruction to the driving motor 300 based on the control parameters, thereby Adjust the current output value, voltage output value and/or power output value of the drive motor 300, etc.
  • the controller 900 may determine whether the catheter-involved heart pump 10 is working abnormally based on the current signal of the driving motor 300 .
  • the controller 900 can preset a safe current range value (or threshold), and after acquiring the current signal of the driving motor 300, compare the current signal with the safe current range value (or threshold): if the current If the signal is within the safe current range (eg, less than the threshold), the controller 900 generates a determination result that the catheter-involved heart pump 10 is working normally; if the current signal is outside the safe current range (eg, greater than the threshold), then The controller 900 generates a determination result that the catheter-involved heart pump 10 is operating abnormally.
  • the controller 900 determines that the catheter-involved heart pump 10 is working abnormally, it can send an alarm message so that the operator can perform timely maintenance or correction.
  • Figure 13 is an exemplary structural schematic diagram of a controller according to some embodiments of this specification.
  • the controller 900 of the catheter-involved heart pump 10 may include a storage medium 930, a processor 940, and a communication bus.
  • the processor 940 and the storage medium 930 can implement the communication process through the communication bus.
  • the processor 940 may be used to execute the control method of the catheter-involved heart pump 10 provided by any of the above embodiments of the present application.
  • the processor 940 may be implemented using a central processing unit, a server, a terminal device, or any other possible processing device.
  • the above-mentioned central processor, server, terminal device or other processing device can be implemented on a cloud platform.
  • the above-mentioned central processor, server or other processing device can be interconnected with various terminal devices, and the terminal device can complete information processing work or part of the information processing work.
  • storage medium 930 may store data and/or instructions.
  • the storage medium 930 may store computer instructions, and the processor 940 (or computer) may read the computer instructions to execute the control method of the catheter-involved heart pump 10 provided in any embodiment of this specification.
  • the storage device may include mass memory, removable memory, volatile read-write memory, read-only memory (ROM), etc., or any combination thereof.
  • the storage device may be implemented on a cloud platform.
  • the catheter-interposed heart pump can be inserted into the heart (such as the left ventricle) to increase the perfusion pressure of the heart through impeller pressurization, increase the heart's pumping function, and provide the heart with Reduce the burden on.
  • the drainage tube has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the drainage tube to guide the blood flow of the left ventricle into the aorta;
  • the front end of the pigtail catheter It is curled in the natural state, and its curled shape is not easy to fold, twist and slip off in the heart;
  • the sterile protective bag is placed on the catheter to prevent the catheter from being contaminated by bacteria during use or recycling and reduce infection Risk;
  • the working status of the catheter-involved heart pump can be easily learned, so that the performance and clinical effect of the catheter-involved heart pump can be monitored, and guidance can be provided
  • the catheter-intervention heart pump works better;
  • By determining the position of the drainage tube it can be judged based on the position whether the catheter-intervention heart pump is installed at the location required for treatment.
  • the controller can issue an early warning message in time. Reduce user risk. It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the possible beneficial effects may be any one or a combination of the above, or any other possible beneficial effects.

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

Abstract

Une pompe cardiaque à intervention par cathéter (10) comprenant un tube de drainage (100), une roue (200), un moteur d'entraînement (300) et un cathéter (400). L'extrémité avant du tube de drainage (100) est pourvue d'une entrée de fluide (110), et l'extrémité arrière du tube de drainage (100) est pourvue d'une sortie de fluide (120). Au moins une section du tube de drainage (100) comprend un tube à ressort (130), et le tube à ressort (130) présente une forme incurvée lorsqu'il se trouve dans un état naturel. La roue (200) est disposée à l'intérieur du tube de drainage (100). Le moteur d'entraînement (300) est utilisé pour entraîner la roue (200) en rotation. Le moteur d'entraînement (300) comprend un côté stator et un arbre rotatif de sortie (320). L'arbre rotatif de sortie (320) est relié de manière fixe à la roue (200). L'extrémité avant du côté stator est reliée de manière fixe à l'extrémité arrière du tube de drainage (100), et l'extrémité arrière du côté stator est reliée de manière fixe à l'extrémité avant du cathéter (400).
PCT/CN2023/093576 2022-05-24 2023-05-11 Pompe cardiaque à intervention par cathéter WO2023226779A1 (fr)

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WO2024103207A1 (fr) * 2022-11-14 2024-05-23 生命盾医疗技术(苏州)有限公司 Canule pour pompage d'assistance ventriculaire, et dispositif d'assistance ventriculaire
CN116328173A (zh) * 2023-03-09 2023-06-27 上海玮启医疗器械有限公司 一种辅助心脏泵血的监测导管、监测系统及方法

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