WO2016041220A1 - 一种左心室辅助装置 - Google Patents

一种左心室辅助装置 Download PDF

Info

Publication number
WO2016041220A1
WO2016041220A1 PCT/CN2014/087651 CN2014087651W WO2016041220A1 WO 2016041220 A1 WO2016041220 A1 WO 2016041220A1 CN 2014087651 W CN2014087651 W CN 2014087651W WO 2016041220 A1 WO2016041220 A1 WO 2016041220A1
Authority
WO
WIPO (PCT)
Prior art keywords
segment
tube
ventricular
outer tube
assist device
Prior art date
Application number
PCT/CN2014/087651
Other languages
English (en)
French (fr)
Inventor
靳立军
成正辉
颜世平
Original Assignee
靳立军
湖南埃普特医疗器械有限公司
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
Priority claimed from CN201410468040.9A external-priority patent/CN104174078B/zh
Priority claimed from CN201420528554.4U external-priority patent/CN204147329U/zh
Application filed by 靳立军, 湖南埃普特医疗器械有限公司 filed Critical 靳立军
Priority to US15/022,801 priority Critical patent/US9981078B2/en
Publication of WO2016041220A1 publication Critical patent/WO2016041220A1/zh

Links

Images

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
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • 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
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable 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
    • A61M60/148—Implantable 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 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
    • 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
    • A61M60/295—Balloon pumps for circulatory assistance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/497—Details relating to driving for balloon pumps for circulatory assistance
    • 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
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into 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
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • 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
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps

Definitions

  • the invention relates to the technical field of interventional medical devices, in particular to a left ventricular assist device.
  • cardiovascular diseases account for about 30% of all diseases. It is estimated that cardiovascular diseases will account for 40% of all diseases in 2020. Most of these diseases eventually affect left ventricular function and cause left ventricular failure. Left ventricular function diseases such as cardiogenic shock.
  • LVAD Left ventricular assist devices
  • LVAD is aimed at patients with left ventricular dysfunction, and drain left ventricular blood to the aorta to provide circular support.
  • LVAD is divided into implanted and paraventricular type according to whether it is implanted into the body; it is divided into pulsating type and axial flow type according to blood flow form.
  • Conventional left ventricular assist devices are surgically implanted by creating a channel in the middle of the left ventricle and aorta with a pump in between.
  • the percutaneous left ventricular assist device with more clinical applications mainly includes extracorporeal membrane oxygenation (Ecmo) and intra-aortic balloon counterpulsation (intra-aortic). Balloon counter pulsation (abbreviated as IABP), Tandem Heart percutaneous left ventricular assist device and Impella ventricular assist system.
  • Ecmo extracorporeal membrane oxygenation
  • intra-aortic balloon counterpulsation intra-aortic balloon counterpulsation
  • Balloon counter pulsation abbreviated as IABP
  • Tandem Heart percutaneous left ventricular assist device Tandem Heart percutaneous left ventricular assist device
  • Impella ventricular assist system In the Ecmo system, two catheters are implanted in the aorta and the main vein respectively. The catheter in the main vein is connected to an external artificial lung, and the external artificial lung is connected to an axial pump or a pulsating pump, and then connected to the catheter in the aorta.
  • Intra-aortic balloon counterpulsation is a long balloon in the aorta.
  • the balloon fills and deflates with the heart to enhance the blood supply to the heart.
  • the disadvantage is that it depends on the function of the ventricle and the work is unstable.
  • the Tandem Heart system consists of an inflow tube that punctures through the femoral vein into the left atrium, an external central pump, and an outflow tube that punctures the femoral artery into the left ventricle. The left atrium to the femoral artery drainage channel is established.
  • the disadvantage is that there are two large wounds, operation. Complex, need to be separated by atrial septum.
  • the Impella system consists of a catheter that punctures the femoral artery into the left ventricle.
  • the catheter has a cage-shaped blood inlet at the front end.
  • An axial pump is placed between the inlet and the outlet to drain the left ventricle.
  • the disadvantage is that the flow depends on the speed of the pump, and rotating the blade at high speed may destroy red blood cells.
  • an object of the present invention is to provide a left ventricular assist device which, in order to simplify the structure and operation, completes the left ventricular assist function, improves work reliability, and reduces trauma to human tissues and cells.
  • the present invention provides the following technical solutions:
  • a left ventricular assist device comprising:
  • An outer tube comprising a ventricular segment located in the left ventricle and an artery segment located in the aorta, wherein the wall of the ventricular segment is provided with a first suction mesh, and the wall of the artery segment is open a first discharge mesh, the outer tube is closed at one end, and the other end is used for connecting an external driving device;
  • a ventricular side suction member disposed in the ventricular segment for introducing blood in the left ventricle into the lumen of the outer tube when the external drive is aspirated, when the external drive is stamped And for preventing blood in the outer tube from being discharged from the ventricular segment;
  • Discharging the balloon tube Discharging the balloon tube, the two ends of which are sealed and fixed on the outer wall of the artery segment, and the second discharge mesh is opened in the tube wall of the discharge segment, the second discharge mesh and the The position of the first discharge mesh is staggered and does not overlap.
  • the discharge segment balloon tube is sealed and attached to the outer wall of the artery segment when the external driving device is stamped.
  • the exhaust section balloon tube and the The outer wall of the arterial segment separates to form a gap.
  • the ventricular side suction member is a suction section balloon tube, and both ends thereof are sealingly fixed on an inner wall of the ventricular segment, and the suction section is on the balloon tube.
  • a second suction mesh opening is opened, the second suction mesh hole is offset from the first suction mesh hole and does not overlap, and the suction segment balloon tube is a ductile material when the external driving device When sucking, the suction section balloon tube forms a gap with the inner wall of the ventricular segment, and when the external driving device is stamped, the suction section balloon tube seal fits on the inner wall of the ventricular segment .
  • the ventricular side suction member is a one-way valve disposed inside the ventricular segment and located between the ventricular segment and the artery segment, the one-way The unidirectional conduction direction of the valve is directed from the ventricular segment to the segment of the artery.
  • a joint connected to the distal end of the outer tube is further included, and the joint is used to connect the external driving device.
  • the joint includes a first branch tube and a second branch tube, and the first branch tube is connected to the external driving device;
  • the utility model further comprises a guide wire cavity, the guide wire cavity is inserted through the inner part of the outer tube, the proximal end of the guide wire cavity is sealed and fixed with the proximal end of the outer tube, and protrudes from the proximal end of the outer tube
  • the distal end of the guide wire lumen is sealed and fixed to the end of the second branch tube and communicates with the outside.
  • a guide wire lumen is further included, and the guide wire lumen is fixed on an outer wall of the proximal end of the outer tube.
  • the proximal end of the guide wire lumen has a ring-like structure that is curved toward the distal end.
  • a development indicator disposed on the outer tube and located between the ventricular segment and the artery segment is further included.
  • the outer tube is a single layer structure, and the single layer structure is a metal mesh tube; or the outer tube is a multi-layer structure, including an inner layer from the inside to the outside,
  • the inner layer is a polytetrafluoroethylene film, an intermediate layer and an outer layer, the intermediate layer is a steel mesh or a spring, and the outer layer is a nylon layer.
  • the ventricular segment of the outer tube and the artery segment is 135 ° ⁇ 155 °.
  • the ventricular side suction member is disposed in the ventricular segment of the outer tube, and the discharge portion of the balloon tube is sealed on the outer wall of the artery portion of the outer tube.
  • the left ventricular assist device is punctured into the heart such that the ventricular segment of the outer tube is located in the left ventricle, the arterial segment of the outer tube is located in the aorta, and the ventricular segment and the segment of the artery are separated by the aortic valve between the left ventricle and the aorta.
  • Complementary interference when working, when the external driving device is pumping, a negative pressure is formed in the outer tube, and under the action of the negative pressure, the discharge balloon tube is adsorbed and attached to the outer wall of the artery segment, because the second discharge mesh and the first The position of the discharge mesh is staggered and does not overlap.
  • the discharge segment balloon seals the first discharge mesh on the artery segment, and the arterial segment of the outer tube is not connected to the aorta, and at the same time, the ventricular side
  • the suction member draws blood from the left ventricle into the ventricular side of the outer tube and into the entire lumen of the outer tube under the suction of the external driving device; afterwards, when the external driving device is punched into the outer tube,
  • the ventricular side suction member prevents blood in the outer tube from being discharged from the ventricular segment to the left ventricle, and at the same time, under the action of the punching, the discharge portion of the balloon tube is detached from the sealing of the artery segment, and a flow gap is formed therebetween.
  • the left ventricular assist device of the invention does not need to be provided with artificial lungs and the like, has a simple structure, does not stop working due to interruption of the pulmonary circulation, has enhanced reliability, and only needs to open a puncture hole in the body, and has little trauma to body tissues. And it will not cause damage to blood cells.
  • FIG. 1 is a schematic structural view of a first left ventricular assist device according to an embodiment of the present invention
  • Figure 2 is a partial schematic view of the A direction in Figure 1;
  • Figure 3 is a schematic view showing the structure of the ventricle section and the suction section balloon tube of the outer tube of the left ventricular assist device of Figure 1;
  • FIG. 4 is a schematic structural view of an arteral segment and a discharge segment balloon tube of the outer tube of the left ventricular assist device of FIG. 1;
  • FIG. 5 is a schematic structural diagram of a second left ventricular assist device according to an embodiment of the present invention.
  • FIG. 6 is a schematic structural diagram of a third left ventricular assist device according to an embodiment of the present invention.
  • Figure 7 is a partial schematic view of the B direction in Figure 6;
  • FIG. 8 is a schematic structural diagram of a fourth left ventricular assist device according to an embodiment of the present invention.
  • FIG. 9 is a schematic structural diagram of a fifth left ventricular assist device according to an embodiment of the present invention.
  • FIG. 10 is a schematic structural diagram of a sixth left ventricular assist device according to an embodiment of the present invention.
  • 11 is a joint
  • 111 is a first branch pipe
  • 112 is a second branch pipe
  • 12 is an outer pipe
  • 121 is a first discharge mesh
  • 122 is an intermediate layer
  • 123 is an outer layer.
  • 124 is the inner layer
  • 125 is the first suction mesh
  • 13 is the guide wire cavity
  • 131 is the ring structure
  • 14 is the discharge balloon tube
  • 141 is the second discharge mesh
  • 15 is the suction section balloon tube
  • 151 The second suction mesh
  • 16 is a development indicator
  • 18 is a one-way valve.
  • the core of the present invention is to provide a left ventricular assist device, which simplifies the structure and operation under the premise of completing the left ventricular assist function, improves the work reliability, and reduces the trauma to human tissues and cells.
  • an embodiment of the present invention provides a left ventricular assist device including an outer tube 12, a ventricular side suction member, and a discharge portion balloon tube 14.
  • the outer tube 12 comprises a ventricular segment and an artery segment, the ventricular segment is adjacent to the artery segment, the outer tube 12 is relatively hard, and has good radial compression resistance.
  • the ventricular segment is located in the left ventricle, and the artery segment is located in the aorta; a first suction mesh hole 125 is defined in the wall of the ventricular segment, and a first discharge mesh hole 121 is defined in the artery segment, and one end of the outer tube 12 is closed, and the other end is closed.
  • the external driving device provides suction and punching force; the ventricular side suction member is disposed in the ventricular segment, and the ventricular side suction member introduces blood in the left ventricle when the external driving device is aspirated In the lumen of the tube 12, when the external driving device is punched, the ventricular side suction member blocks the blood in the outer tube from the ventricular segment to the left ventricle; the outlet portion of the balloon tube 14 is sealed and fixed on the outer wall of the artery segment.
  • the first discharge mesh hole 121 is completely covered in the discharge section balloon tube 14, and the second discharge mesh hole 141 is opened in the pipe wall of the discharge section balloon tube 14, and the second discharge mesh hole 141 and the first discharge are opened.
  • the positions of the mesh holes 121 are staggered and do not overlap.
  • the discharge portion of the balloon tube 14 is made of a medical material having good tensile properties, is very thin and very soft, and is discharged from the balloon tube 14 when the external driving device is aspirated.
  • the first expelling mesh 121 and the second expelling mesh 141 are non-conducting, and when the external driving device is punched, the expelling segment balloon tube 14 expands and is separated from the outer wall of the arterial segment. Fit, form a gap, the first discharge mesh 121
  • the second discharge cell 141 is turned on.
  • the working process and working principle of the left ventricular assist device are as follows: during operation, the device is flushed with heparin saline, and exhausted to connect the outer tube 12 with the external driving device, and the external driving device is connected to the cavity of the outer tube 12 cavity. Wash with heparin saline and fill with heparin saline and vent. After completing the necessary work of the operation, the guide wire is inserted into the aorta through the sheath of the femoral artery puncture site, and finally reaches the left ventricle, so that the ventricular segment of the outer tube 12 is located in the left ventricle, and the artery segment of the outer tube 12 is located in the aorta.
  • the ventricular segment and the segment of the artery are separated by an aortic valve between the left ventricle and the aorta.
  • a negative pressure is formed in the outer tube 12, and under the action of the negative pressure, the discharge portion balloon tube 14 is adsorbed and contracted, and is attached to the outer wall of the artery segment due to the second discharge mesh.
  • the position of the first discharge mesh 121 is staggered and does not overlap.
  • the discharge section balloon tube 14 seals the first discharge mesh 121 on the artery segment, and the first discharge mesh 121 and the second discharge net If the hole 141 is not conductive, the artery segment of the outer tube 12 is not in communication with the aorta, and blood in the aorta does not enter the outer tube 12, while the ventricular side suction member is under the suction of the external driving device.
  • the left ventricular assist device of the present invention does not need to be provided with artificial lungs and the like, has a simple structure, does not stop working due to interruption of the pulmonary circulation, has enhanced reliability, and only needs to open a puncture hole on the body for body tissues.
  • the trauma is small and does not cause damage to blood cells.
  • the external driving device can adjust the suction and the punching frequency according to the actual pulse frequency of the human body, realize frequency synchronization, thereby realizing the auxiliary function of the left ventricle.
  • the ventricular side suction member is a suction section balloon tube 15 disposed inside the ventricular segment, and both ends are sealed and fixed on the inner wall of the ventricular segment, and
  • the first suction mesh hole 125 is covered in the suction section balloon tube 14, and the second suction mesh hole 151 is opened in the suction section balloon tube 15, and the position of the second suction mesh hole 151 and the first suction mesh hole 125 is opened.
  • the staggered balloon tube 15 is made of a medical material with better tensile properties, and is also very thin and soft.
  • the specific structure is shown in FIG. 3 .
  • the suction section balloon tube 15 When the suction section balloon tube 15 is in operation, when the external driving device is sucked, a negative pressure is formed inside the outer tube 12, and the suction section balloon tube 15 contracts under the suction of the negative pressure, and the contraction rate is greater than that of the outer tube 12 The contraction rate forms a flow gap between the suction segment balloon tube 15 and the inner wall of the ventricular segment, and the first suction mesh 125 is electrically connected to the second suction mesh 151. At this time, blood is drawn into the ventricular segment from the left ventricle.
  • the suction section balloon tube 15 is inflated, the sealing is attached to the inner wall of the ventricular segment, the first suction mesh 125 and the second inhalation
  • the mesh 151 is non-conducting and blood in the outer tube 12 is not discharged through the suction segment balloon tube 15 of the ventricular segment to the left ventricle.
  • the ventricular side suction member is either a one-way valve 18 disposed within the ventricular segment and between the ventricular segment and the arterial segment, the one-way valve 18 The unidirectional conduction direction is directed to the arterial segment by the ventricular segment.
  • the working principle and working process of the ventricular side suction member using the one-way valve 18 is that when the external driving device draws, a negative pressure is formed in the outer tube 12, and the blood is sucked through the first suction mesh 125 on the ventricular segment.
  • the ventricular segment, and under the action of suction, blood entering the ventricular segment enters the arterial segment through a one-way valve 18 disposed between the ventricular segment and the segment of the artery, and flows through the entire outer tube 12 and the lumen of the external drive device
  • the external drive unit is stamped, since the one-way valve 18 has a single-pass performance, only The blood is allowed to circulate from the ventricular segment to the arterial segment.
  • the blood is prevented from flowing to the ventricular segment by the one-way valve 18, and the blood does not return from the ventricular segment to the left ventricle, but can only be discharged from the discharge segment balloon tube 14 to the aorta to complete the blood.
  • the flow from the left ventricle to the aorta is prevented from flowing to the ventricular segment by the one-way valve 18, and the blood does not return from the ventricular segment to the left ventricle, but can only be discharged from the discharge segment balloon tube 14 to the aorta to complete the blood. The flow from the left ventricle to the aorta.
  • the left ventricular assist device further includes a joint 11 connected to the distal end of the outer tube 12, and the joint 11 is used for connection with an external driving device according to different external driving devices.
  • the outer tube 12 structure changes the structure of the joint 11, the only need to replace the joint 11, to increase the scope of application of the left ventricular assist device, the joint 11 is an injection molded part, using plastic, the joint 11 thread is a standard Luer joint structure.
  • the external drive can also be connected directly to the outer tube 12.
  • a joint structure of a joint 11 and a guide wire cavity 13 is provided, and the joint 11 includes a first branch pipe 111 and a second branch pipe. 112, the first branch tube 111 is connected with an external driving device; the left ventricular assist device includes a guide wire cavity 13 for passing through the guide wire, and guiding the left ventricular assist device under the guiding action of the guide wire and the guide wire cavity 13 The sheath of the arterial puncture site penetrates the aorta and eventually reaches the left ventricle.
  • the guide wire lumen 13 in this embodiment is inserted through the inner portion of the outer tube 12, the proximal end of the guidewire lumen 13 is sealed and fixed to the proximal end of the outer tube 12, and extends to the proximal end of the outer tube 12, and the guidewire lumen 13 The telecentric end is sealed and fixed to the end of the second branch pipe 112, and communicates with the outside.
  • This guide wire cavity 13 has a high mounting structure stability.
  • the mounting structure of the joint 11 and the guide wire cavity 13 may be other structures in addition to the above structure.
  • the joint 11 has a branch pipe directly connected to the external driving device, and the guide wire cavity 13 is fixed on the outer wall of the proximal end of the outer tube 12, because the length is short, the hardness of the guide wire cavity 13 itself does not affect the bending performance of the entire outer tube 12, and can be more flexibly and quickly penetrated into position, and the guide The wire cavity 13 can be directly replaced outside the outer tube 12, and the replacement is convenient and quick.
  • the proximal end of the guidewire lumen 13 has a loop-like structure 131 that curves toward the distal end, similar to the pigtail shape. Since the proximal end of the guidewire lumen 13 is provided as a curved loop-like structure 131, the tip end of the guidewire lumen 13 does not cause damage to human tissue, particularly the inner wall of the heart, during the puncture of the guidewire lumen 13.
  • the left ventricular assist device further includes a development indicator 16 disposed on the outer tube 12 between the ventricular segment and the artery segment, and the development indicator 16
  • the number is preferably two, and the area between the two development indicators 16 is the stop puncture of the left ventricular assist device. In the region, the development indicator 16 is used for the puncture process of the left ventricular assist device.
  • the left ventricular assist device enters the left ventricle through the aorta
  • the position of the left ventricular assist device is observed by the development indicator 16 when the two development indicators 16
  • the puncture is stopped and the left ventricular assist device is secured.
  • the ventricular segment of the outer tube 12 enters the left ventricle and the arterial segment is located in the aorta.
  • the material of the development indicator 16 is platinum rhodium alloy, gold, or the like, and the position of the development indicator 16 is observed by a developing device such as X-ray.
  • the outer tube 12 is a multi-layer structure, which may be a three-layer structure, stream-forming type, including an inner layer 124, an intermediate layer 122 and an outer layer in order from the inside to the outside.
  • inner layer 124 is a polytetrafluoroethylene film, has the advantages of low friction coefficient, good biocompatibility, good lubricating performance, does not destroy tissue cells
  • the intermediate layer 122 is a wire mesh or a spring, in suction and compression.
  • the outer layer 123 is a nylon layer, such as Pebax 55D, which has good plasticity, so that the device is It has good tracking performance and folding resistance when bypassing curved blood vessels.
  • the outer tube 12 may also have a two-layer structure, a flow-forming type, an inner layer of a polytetrafluoroethylene film, and an outer layer of nylon such as Pebax 63D.
  • the outer tube 12 may also be a single layer structure, as shown in FIG. 6, FIG. 7 and FIG. 10, and the single layer structure is a metal mesh tube.
  • the outer tube 12 of other materials and structures is equally applicable as long as the outer tube has good radial compression resistance and passability.
  • the angle between the ventricular segment of the outer tube 12 and the artery segment is 135 to 155, more preferably 145, depending on the positional relationship between the heart and the aorta. Determining the angle between the ventricular segment and the arterial segment facilitates insertion of the outer tube 12 into the blood vessel.
  • different angles are set according to different cardiac structures, and are not limited to the ranges and values enumerated in this embodiment.
  • the first suction mesh hole 125 and the first discharge mesh hole 121 can be drilled by laser or directly drilled, and the hole penetrates the wall of the outer tube 12, and there is no burr around the hole to prevent a small space from being formed. And blood clotting.
  • the material of the discharge segment balloon tube 14 can be made of a nylon material, such as PU8AE, which is easily deformed under pressure, similar to a balloon on a balloon catheter, which can be inflated by stamping and can be contracted by pressure relief.
  • the material of the suction section balloon tube 15 can be made of a nylon material and is easily deformed when subjected to pressure.
  • a second suction mesh 151 and The second discharge mesh 141 can be drilled by laser or directly drilled.
  • the left ventricular assist device of the present invention draws blood through a plurality of first suction mesh holes 125 on the outer tube 12 and a second suction mesh hole 151 on the suction segment balloon tube 15 through the discharge portion of the balloon tube 14
  • the plurality of second discharge mesh holes 141 and the plurality of first discharge mesh holes 121 on the outer tube 12 discharge blood, thereby ensuring a large flow of blood, completely replacing the normal human heart function, and the blood is directly drawn from the left ventricle. Oxygenated blood to the aorta, in line with the body's hemodynamics.
  • the left ventricular assist device of the invention is suitable for auxiliary treatment such as heart failure, cardiogenic shock, heart transplantation, and interventional therapy for complicated coronary lesions, and can also be used for rescue of cardiac arrest.

Abstract

一种左心室辅助装置包括：外管(12)，其包括位于左心室中的心室段和位于主动脉中的动脉段，心室段上开设有第一吸入网孔(125)，动脉段上开设有第一排出网孔(121)，外管(12)连通外部驱动装置；心室侧抽吸部件，其设置在心室段内；排出段球囊管(14)，其两端密封套固在动脉段的外壁上，排出段球囊管(14)开设有第二排出网孔(141)，第二排出网孔(141)与第一排出网孔(121)的位置错开且不搭接。在该左心室辅助装置中，通过外部驱动装置的抽吸和冲压，利用心室侧抽吸部件将血液从左心室吸入外管(12)中，利用排出段球囊管(14)将血液从外管(12)排向主动脉，实现一个循环，将左心室内的血液泵入主动脉。该左心室辅助装置结构简单，可靠性强，对身体组织的创伤小，并且不会对血细胞产生破坏。

Description

一种左心室辅助装置
本申请要求于2014年09月15日提交中国专利局、申请号为201410468040.9、发明名称为“一种左心室辅助装置”的中国专利申请的优先权，以及2014年09月15日提交中国专利局、申请号为201420528554.4、发明名称为“一种左心室辅助装置”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及介入医疗器械技术领域，特别涉及一种左心室辅助装置。
背景技术
近年来，心血管疾病发病率增加。据世界卫生组织调查研究，目前，心血管疾病占所有疾病的30％左右，预计2020年心血管疾病将占到所有疾病的40％，其中，多数疾病最终影响到左心室功能，造成左心室衰竭、心源性休克等左心室功能疾病。
针对左心室功能疾病，国内外学者提出新的方法，左心室辅助装置(Left ventricular assist devices，英文缩写为LVAD)是针对左心功能不全患者，将左心室血液引流到主动脉，从而提供循环支持。LVAD按是否植入体内分为植入型和体旁型；按血液流动形式分为脉动型和轴流型。
传统的左心室辅助装置是通过外科手术植入，通过在左心室和主动脉上打孔，中间设置泵，建立通道。
外科手术植入创伤大，目前，临床应用较多的经皮左心室辅助装置主要有体外膜肺氧合系统(Extracorporeal membrane oxygenation，英文缩写为Ecmo)、主动脉内球囊反搏(intra-aortic balloon counter pulsation，英文缩写为IABP)、Tandem Heart经皮左心室辅助装置和Impella心室辅助系统。Ecmo系统是在主动脉和主静脉中分别植入两根导管，主静脉中的导管连接外置人工肺，外置人工肺连接轴流泵或脉动泵，再连接主动脉中的导管，缺点是建立需外置人工肺， 结构复杂，肺循环中断，易造成肺血管内血栓形成，且易大出血。主动脉内球囊反搏术是在主动脉介入一个长球囊，球囊随着心脏跳动充、排气，增强心肌供血，缺点是依赖于心室的功能，工作不稳定。Tandem Heart系统是由经股静脉穿刺到左心房的流入管、体外中心泵、经股动脉穿刺到左心室的流出管组成，建立左心房到股动脉引流通道，缺点是有两处创伤大，操作复杂，需房间隔穿刺。Impella系统是由经股动脉穿刺到左心室的导管组成，导管前端有笼状的血液流入口，位于升主动脉有流出口，流入口和流出口之间有轴流泵，将左心室血液引流到主动脉，缺点是流量依赖于泵的转速，高速转动叶片可能破坏红细胞等。
综上所述，在完成左心室辅助功能的前提下，如何解决现有的左心室辅助装置结构和操作复杂，工作不稳定，对人体组织细胞创伤大的问题，成为了本领域技术人员亟待解决的问题。
发明内容
有鉴于此，本发明的目的在于提供一种左心室辅助装置，在完成左心室辅助功能的前提下，以简化结构和操作，提高工作可靠性，减小对人体组织和细胞的创伤。
为达到上述目的，本发明提供以下技术方案：
一种左心室辅助装置，包括：
外管，所述外管包括位于左心室中的心室段和位于主动脉中的动脉段，所述心室段的管壁上开设有第一吸入网孔，所述动脉段的管壁上开设有第一排出网孔，所述外管一端封闭，另一端用于连通外部驱动装置；
心室侧抽吸部件，设置在所述心室段内，当所述外部驱动装置抽吸时，用于将左心室中的血液引入到所述外管的管腔中，当所述外部驱动装置冲压时，用于阻止所述外管中的血液从所述心室段排出；
排出段球囊管，其两端密封套固在所述动脉段的外壁上，所述排出段球囊管的管壁上开设有第二排出网孔，所述第二排出网孔与所述第一排出网孔的位置错开且不搭接，当所述外部驱动装置抽吸时，所述排出段球囊管密封贴合在所述动脉段的外壁上，当所述外部驱动装置冲压时，所述排气段球囊管与所述 动脉段的外壁分离，形成间隙。
优选的，在上述的左心室辅助装置中，所述心室侧抽吸部件为抽吸段球囊管，其两端密封固定在所述心室段的内壁上，所述抽吸段球囊管上开设有第二吸入网孔，所述第二吸入网孔与所述第一吸入网孔的位置错开且不搭接，所述抽吸段球囊管为延展性材料，当所述外部驱动装置抽吸时，所述抽吸段球囊管与所述心室段的内壁形成间隙，当所述外部驱动装置冲压时，所述抽吸段球囊管密封贴合在所述心室段的内壁上。
优选的，在上述的左心室辅助装置中，所述心室侧抽吸部件为设置在所述心室段内部、且位于所述心室段和所述动脉段之间的单向瓣膜，所述单向瓣膜的单向导通方向为由心室段指向动脉段。
优选的，在上述的左心室辅助装置中，还包括与所述外管的远心端连接的接头，所述接头用于连接所述外部驱动装置。
优选的，在上述的左心室辅助装置中，所述接头包括第一分支管和第二分支管，所述第一分支管与所述外部驱动装置连接；
还包括导丝腔，导丝腔贯穿于所述外管的内部，所述导丝腔的近心端与所述外管的近心端密封固定，并伸出所述外管的近心端，所述导丝腔的远心端与所述第二分支管的端部密封固定，并与外部连通。
优选的，在上述的左心室辅助装置中，还包括导丝腔，所述导丝腔固定在所述外管的近心端的外壁上。
优选的，在上述的左心室辅助装置中，所述导丝腔的近心端具有向远心端方向弯曲的圈状结构。
优选的，在上述的左心室辅助装置中，还包括设置在所述外管上且位于所述心室段和所述动脉段之间的显影示标。
优选的，在上述的左心室辅助装置中，所述外管为单层结构，所述单层结构为金属网管；或者，所述外管为多层结构，由内至外依次包括内层、所述内层为聚四氟乙烯膜，中间层和外层，所述中间层为钢丝网或弹簧，所述外层为尼龙层。
优选的，在上述的左心室辅助装置中，所述外管的心室段与所述动脉段之 间的夹角135°～155°。
与现有技术相比，本发明的有益效果是：
本发明提供的左心室辅助装置中，心室侧抽吸部件设置在外管的心室段内，排出段球囊管两端密封套在外管的动脉段的外壁上。将左心室辅助装置穿刺到心脏内，使外管的心室段位于左心室中，外管的动脉段位于主动脉中，心室段和动脉段被左心室与主动脉之间的主动脉瓣分开，互补干涉，工作时，当外部驱动装置抽吸时，外管内形成负压，在负压作用下，排出段球囊管被吸附贴合在动脉段的外壁上，由于第二排出网孔与第一排出网孔的位置错开排列且不搭接，因此，排出段球囊管将动脉段上的第一排出网孔封住，外管的动脉段与主动脉不连通，与此同时，心室侧抽吸部件在外部驱动装置的抽吸作用下，将左心室中的血液抽吸进入外管的心室侧，并且进入外管整个管腔中；之后，当外部驱动装置向外管中冲压时，心室侧抽吸部件阻止外管中的血液从心室段排向左心室，与此同时，在冲压作用下，排出段球囊管脱离与动脉段的密封贴合，两者之间形成流通间隙，第一排出网孔与第二排出网孔导通，血液从外管的动脉段进入主动脉中。通过外部驱动装置的抽吸和冲压过程实现一个循环，将左心室内的血液泵入主动脉。本发明的左心室辅助装置不需要设置人工肺等部件，结构简单，不会因为肺循环的中断而停止工作，可靠性增强，且只需要在身体上开设一个穿刺孔，对身体组织的创伤小，并且不会对血细胞产生破坏。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据提供的附图获得其他的附图。
图1为本发明实施例提供的第一种左心室辅助装置的结构示意图；
图2为图1中的A向局部示意图；
图3为图1中的左心室辅助装置的外管的心室段与抽吸段球囊管的结构示意图；
图4为图1中的左心室辅助装置的外管的动脉段与排出段球囊管的结构示意图；
图5为本发明实施例提供的第二种左心室辅助装置的结构示意图；
图6为本发明实施例提供的第三种左心室辅助装置的结构示意图；
图7为图6中的B向局部示意图；
图8为本发明实施例提供的第四种左心室辅助装置的结构示意图；
图9为本发明实施例提供的第五种左心室辅助装置的结构示意图；
图10为本发明实施例提供的第六种左心室辅助装置的结构示意图。
在上述图1-图10中，11为接头、111为第一分支管、112为第二分支管、12为外管、121为第一排出网孔、122为中间层、123为外层、124为内层、125为第一吸入网孔、13为导丝腔、131为圈状结构、14为排出球囊管、141为第二排出网孔、15为抽吸段球囊管、151为第二吸入网孔、16为显影示标、18为单向瓣膜。
具体实施方式
本发明的核心是提供了一种左心室辅助装置，在完成左心室辅助功能的前提下，简化了结构和操作，提高了工作可靠性，减小了对人体组织和细胞的创伤。
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
请参考图1-图10，本发明实施例提供了一种左心室辅助装置，包括外管12、心室侧抽吸部件和排出段球囊管14。其中，外管12包括心室段和动脉段，心室段与动脉段相邻，外管12较硬，具有良好的径向抗压性能，使用时，心室段位于左心室内，动脉段位于主动脉内；心室段的管壁上开设有第一吸入网孔125，动脉段上开设有第一排出网孔121，且外管12的一端封闭，另一端用 于连通外部驱动装置，外部驱动装置提供抽吸力和冲压力；心室侧抽吸部件设置在心室段内，当外部驱动装置抽吸时，心室侧抽吸部件将左心室中的血液引入到外管12的管腔中，当外部驱动装置冲压时，心室侧抽吸部件阻止外管中的血液从心室段排向左心室；排出段球囊管14的两端密封套固在动脉段的外壁上，将第一排出网孔121全部覆盖在排出段球囊管14中，且排出段球囊管14的管壁上开设有第二排出网孔141，第二排出网孔141与第一排出网孔121的位置错开排列且不搭接，排出段球囊管14由拉伸性能较好的医用材料制成，很薄、很软，当外部驱动装置抽吸时，排出段球囊管14收缩，密封贴合在动脉段的外壁上，第一排出网孔121与第二排出网孔141不导通，当外部驱动装置冲压时，排出段球囊管14膨胀，与动脉段的外壁脱离贴合，形成间隙，第一排出网孔121与第二排出网孔141导通。
上述左心室辅助装置的工作过程和工作原理是：手术时，用肝素盐水冲洗装置，并排气，将外管12与外部驱动装置连通，外部驱动装置与外管12内腔连接的腔体用肝素盐水冲洗，并注满肝素盐水，排气。完成手术必要的工作后，将导丝经股动脉穿刺部位的鞘管穿入主动脉，最终到达左心室，使外管12的心室段位于左心室中，外管12的动脉段位于主动脉中，心室段和动脉段被左心室与主动脉之间的主动脉瓣分开。工作时，当外部驱动装置抽吸时，外管12内形成负压，在负压作用下，排出段球囊管14被吸附收缩，贴合在动脉段的外壁上，由于第二排出网孔141与第一排出网孔121的位置错开排列且不搭接，因此，排出段球囊管14将动脉段上的第一排出网孔121封住，第一排出网孔121与第二排出网孔141不导通，则外管12的动脉段与主动脉不连通，主动脉中的血液不会进入外管12中，与此同时，心室侧抽吸部件在外部驱动装置的抽吸作用下，将左心室中的血液抽吸进入外管12的心室段内，并且进入外管12整个管腔中以及外部驱动装置的腔体内，此过程完成了血液从左心室进入外管12的操作；之后，外部驱动装置向外管12中进行冲压，心室侧抽吸部件阻止外管12中的血液从心室段排向左心室，与此同时，在冲压作用下，排出段球囊管14膨胀，其管壁脱离与动脉段的外壁密封贴合，两者之间形成流通间隙，第一排出网孔121与第二排出网孔141导通，血液从外管12的动 脉段进入主动脉中，此过程完成血液从外管12进入主动脉的操作。通过外部驱动装置的抽吸和冲压过程实现一个循环，将左心室内的血液泵入主动脉。
可以看出，本发明的左心室辅助装置不需要设置人工肺等部件，结构简单，不会因为肺循环的中断而停止工作，可靠性增强，且只需要在身体上开设一个穿刺孔，对身体组织的创伤小，并且不会对血细胞产生破坏。并且外部驱动装置可以根据人体的实际脉搏频率进行抽吸和冲压频率的调节，实现频率同步，从而实现左心室的辅助功能。
如图1-图7所示，在本发明一具体实施例中，心室侧抽吸部件为抽吸段球囊管15，设置在心室段内部，两端密封固定在心室段的内壁上，将第一抽吸网孔125覆盖在抽吸段球囊管14内，抽吸段球囊管15上开设有第二吸入网孔151，第二吸入网孔151与第一吸入网孔125的位置错开排列且不搭接，抽吸段球囊管15由拉伸性能较好的医用材料制成，同样很薄很软，具体结构参见图3。
抽吸段球囊管15在工作时，当外部驱动装置抽吸时，外管12内部形成负压，抽吸段球囊管15在负压的抽吸作用下收缩，收缩率大于外管12的收缩率，则抽吸段球囊管15与心室段的内壁之间形成流通间隙，第一吸入网孔125与第二吸入网孔151导通，此时，血液从左心室吸入心室段内，并流入整个外管12管腔以及外部驱动装置，当外部驱动装置冲压时，抽吸段球囊管15膨胀，密封贴合在心室段的内壁上，第一吸入网孔125与第二吸入网孔151不导通，外管12中的血液不会通过心室段的抽吸段球囊管15排向左心室。
如图8-图10所示，在本发明一具体实施例中，心室侧抽吸部件或者为设置在心室段内部、且位于心室段和动脉段之间的单向瓣膜18，单向瓣膜18的单向导通方向为由心室段指向动脉段。
则采用单向瓣膜18的心室侧抽吸部件的工作原理和工作过程是：当外部驱动装置抽吸时，外管12内形成负压，血液通过心室段上的第一吸入网孔125被吸入心室段，且在抽吸力的作用下，进入心室段的血液通过设置在心室段和动脉段之间的单向瓣膜18进入动脉段，并流经整个外管12以及外部驱动装置的腔体内，当外部驱动装置冲压时，由于单向瓣膜18具有单向导通性能，只 允许血液从心室段向动脉段流通，因此，血液被单向瓣膜18阻止流向心室段，则血液不会从心室段返回左心室，而只能从排出段球囊管14排向主动脉，完成血液由左心室向主动脉的流动。
如图1-图10所示，在本实施例中，左心室辅助装置还包括与外管12的远心端连接的接头11，接头11用于和外部驱动装置连接，根据不同的外部驱动装置和外管12结构改变接头11的结构形式，只需更换接头11即可，增加左心室辅助装置的适用范围，接头11为注塑件，采用塑料，接头11螺纹为标准鲁尔接头结构。当然，外部驱动装置还可以直接与外管12连接。
如图1、图6、图8和图10所示，在本实施例中，提供了一种接头11形式和导丝腔13的安装结构，接头11包括第一分支管111和第二分支管112，第一分支管111与外部驱动装置连接；左心室辅助装置包括导丝腔13，用于穿过导丝，在导丝和导丝腔13的导向作用下，将左心室辅助装置经股动脉穿刺部位的鞘管穿入主动脉，最终到达左心室。本实施例中的导丝腔13贯穿于外管12的内部，导丝腔13的近心端与外管12的近心端密封固定，并伸出外管12的近心端，导丝腔13的远心端与第二分支管112的端部密封固定，并与外部连通。这种导丝腔13的安装结构稳定性高。
接头11形式和导丝腔13的安装结构除了采用上述结构之外，还可以为其它结构，如图5和图9所示，接头11具有一个分支管，直接与外部驱动装置连接，导丝腔13固定在外管12的近心端的外壁上，由于长度较短，因此，导丝腔13自身的硬度不会影响整个外管12的弯曲性能，可以更灵活、更快速地穿刺到位，而且该导丝腔13可以在外管12外直接进行更换，更换方便快速。
对以上两种导丝腔13进一步优化，如图1-图10所示，导丝腔13的近心端具有向远心端方向弯曲的圈状结构131，类似于猪尾巴形状。由于导丝腔13的近心端设置成弯曲的圈状结构131，则在导丝腔13穿刺的过程中，导丝腔13的尖端不会对人体组织，特别是心脏内壁造成损伤。
在本发明一具体实施例中，如图1-图10所示，左心室辅助装置还包括设置在外管12上且位于心室段和动脉段之间的显影示标16，显影示标16的个数优选为两个，两个显影示标16之间的区域就是左心室辅助装置的停止穿刺 区域，显影示标16用于左心室辅助装置的穿刺过程，当左心室辅助装置经过主动脉进入左心室时，通过显影示标16观察左心室辅助装置到达的位置，当两个显影示标16位于主动脉瓣两侧时，停止穿刺，将左心室辅助装置固定，此时，外管12的心室段进入到左心室中，而动脉段位于主动脉中。
作为优化，显影示标16的材料为铂铱合金、黄金等，通过显影设备，如X光，观察显影示标16的位置。
如图1-图4所示，在本实施例中，外管12为多层结构，可以是三层结构，流变成型，由内至外依次包括内层124、中间层122和外层123；内层124为聚四氟乙烯膜，具有摩擦系数低，良好的生物相容性，润滑性能好的优点，不会破坏组织细胞，中间层122为钢丝网或弹簧，在抽吸和压缩过程中能保持外管12径向不变形，具有良好的径向抗压性，同时也可增强装置的前向推送性能，外层123为尼龙层，如Pebax55D，具有良好的塑性，使得装置在绕过弯曲血管时具有良好的跟踪性能和抗折性能。
外管12还可以是双层结构，流变成型，内层为聚四氟乙烯膜，外层为尼龙，如Pebax63D。
此外，外管12还可以是单层结构，如图6、图7和图10所示，单层结构为金属网管。只要使外管具有良好的径向抗压性和通过性，其它材料和结构的外管12同样适用。
如图1-图10所示，在本实施例中，外管12的心室段与动脉段之间的夹角135°～155°，更优选为145°，根据心脏与主动脉的位置关系，确定心室段与动脉段的夹角，可以方便外管12插入血管中。当然，根据不同的心脏结构设置不同的夹角，并不局限与本实施例所列举的范围和数值。
在本实施例中，第一吸入网孔125和第一排出网孔121可通过激光打孔，也可直接钻孔，孔穿透外管12的管壁，孔周围无毛刺，防止形成小空间而凝血。
排出段球囊管14的材料可以采用尼龙材料，如PU8AE，在受到压力时容易变形，类似球囊导管上的球囊，冲压可膨胀，泄压可收缩。抽吸段球囊管15的材料可以采用尼龙材料，在受到压力时容易变形。第二吸入网孔151和 第二排出网孔141可通过激光打孔，也可直接钻孔。
本发明中的左心室辅助装置通过外管12上的多个第一吸入网孔125和抽吸段球囊管15上的第二吸入网孔151吸进血液，通过排出段球囊管14上的多个第二排出网孔141和外管12上的多个第一排出网孔121排出血液，保证了血液的大流量输送，可完全替代正常人的心脏功能，且血液直接从左心室抽吸含氧血到主动脉，符合人体的血液动力学。
本发明中的左心室辅助装置适用于心力衰竭、心源性休克、心脏移植前等辅助治疗，以及辅助复杂冠脉病变介入治疗，也可用于心脏停跳的抢救。
本说明书中各个实施例采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似部分互相参见即可。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (10)

  1. 一种左心室辅助装置，其特征在于，包括：
    外管(12)，所述外管(12)包括位于左心室中的心室段和位于主动脉中的动脉段，所述心室段的管壁上开设有第一吸入网孔(125)，所述动脉段的管壁上开设有第一排出网孔(121)，所述外管(12)一端封闭，另一端用于连通外部驱动装置；
    心室侧抽吸部件，设置在所述心室段内，当所述外部驱动装置抽吸时，用于将左心室中的血液引入到所述外管(12)的管腔中，当所述外部驱动装置冲压时，用于阻止所述外管(12)中的血液从所述心室段排出；
    排出段球囊管(14)，其两端密封套固在所述动脉段的外壁上，所述排出段球囊管(14)的管壁上开设有第二排出网孔(141)，所述第二排出网孔(141)与所述第一排出网孔(121)的位置错开且不搭接，当所述外部驱动装置抽吸时，所述排出段球囊管(14)密封贴合在所述动脉段的外壁上，当所述外部驱动装置冲压时，所述排气段球囊管(14)与所述动脉段的外壁分离，形成间隙。
  2. 根据权利要求1所述的左心室辅助装置，其特征在于，所述心室侧抽吸部件为抽吸段球囊管(15)，其两端密封固定在所述心室段的内壁上，所述抽吸段球囊管(15)上开设有第二吸入网孔(151)，所述第二吸入网孔(151)与所述第一吸入网孔(125)的位置错开且不搭接，当所述外部驱动装置抽吸时，所述抽吸段球囊管(15)与所述心室段的内壁形成间隙，当所述外部驱动装置冲压时，所述抽吸段球囊管(15)密封贴合在所述心室段的内壁上。
  3. 根据权利要求1所述左心室辅助装置，其特征在于，所述心室侧抽吸部件为设置在所述心室段内部、且位于所述心室段和所述动脉段之间的单向瓣膜(18)，所述单向瓣膜(18)的单向导通方向为由心室段指向动脉段。
  4. 根据权利要求1-3任一项所述的左心室辅助装置，其特征在于，还包括与所述外管(12)的远心端连接的接头(11)，所述接头(11)用于连接所述外部驱动装置。
  5. 根据权利要求4所述的左心室辅助装置，其特征在于，所述接头(11)包括第一分支管(111)和第二分支管(112)，所述第一分支管(111)与所述 外部驱动装置连接；
    还包括导丝腔(13)，导丝腔(13)贯穿于所述外管(12)的内部，所述导丝腔(13)的近心端与所述外管(12)的近心端密封固定，并伸出所述外管(12)的近心端，所述导丝腔(13)的远心端与所述第二分支管(112)的端部密封固定，并与外部连通。
  6. 根据权利要求4所述的左心室辅助装置，其特征在于，还包括导丝腔(13)，所述导丝腔(13)固定在所述外管(12)的近心端的外壁上。
  7. 根据权利要求5或6所述的左心室辅助装置，其特征在于，所述导丝腔(13)的近心端具有向远心端方向弯曲的圈状结构(131)。
  8. 根据权利要求1-3任一项所述的左心室辅助装置，其特征在于，还包括设置在所述外管(12)上且位于所述心室段和所述动脉段之间的显影示标(16)。
  9. 根据权利要求1-3任一项所述的左心室辅助装置，其特征在于，所述外管(12)为单层结构，所述单层结构为金属网管；或者，所述外管为多层结构，由内至外依次包括内层(124)、中间层(122)和外层(123)，所述内层(124)为聚四氟乙烯膜，所述中间层(122)为钢丝网或弹簧，所述外层(123)为尼龙层。
  10. 根据权利要求1-3任一项所述的左心室辅助装置，其特征在于，所述外管(12)的心室段与所述动脉段之间的夹角135°～155°。
PCT/CN2014/087651 2014-09-15 2014-09-28 一种左心室辅助装置 WO2016041220A1 (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US15/022,801 US9981078B2 (en) 2014-09-15 2014-09-28 Left ventricular assist device

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201410468040.9A CN104174078B (zh) 2014-09-15 2014-09-15 一种左心室辅助装置
CN201420528554.4U CN204147329U (zh) 2014-09-15 2014-09-15 一种左心室辅助装置
CN201410468040.9 2014-09-15
CN201420528554.4 2014-09-15

Publications (1)

Publication Number Publication Date
WO2016041220A1 true WO2016041220A1 (zh) 2016-03-24

Family

ID=55532492

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2014/087651 WO2016041220A1 (zh) 2014-09-15 2014-09-28 一种左心室辅助装置

Country Status (2)

Country Link
US (1) US9981078B2 (zh)
WO (1) WO2016041220A1 (zh)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11241571B2 (en) 2019-09-24 2022-02-08 Marvin Liu Implantable ventricular assist device
CN114796817A (zh) * 2022-05-26 2022-07-29 惠州市顺美医疗科技有限公司 超软颅内支持导管
WO2023126204A1 (fr) 2021-12-31 2023-07-06 Bypa Medical Solutions Canule d'admission d'un dispositif d'assistance ou de suppléance du cœur

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10806899B2 (en) * 2016-02-17 2020-10-20 Project Moray, Inc. Local contraction of flexible bodies using balloon expansion for extension-contraction catheter articulation and other uses
US11690645B2 (en) 2017-05-03 2023-07-04 Medtronic Vascular, Inc. Tissue-removing catheter
EP3618737B1 (en) 2017-05-03 2022-03-16 Medtronic Vascular Inc. Tissue-removing catheter
CA3066361A1 (en) 2017-06-07 2018-12-13 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
EP3710076B1 (en) 2017-11-13 2023-12-27 Shifamed Holdings, LLC Intravascular fluid movement devices, systems, and methods of use
EP3746149A4 (en) 2018-02-01 2021-10-27 Shifamed Holdings, LLC INTRAVASCULAR BLOOD PUMPS AND METHODS OF USE AND METHODS OF MANUFACTURING
EP3880096A1 (en) 2018-11-16 2021-09-22 Medtronic Vascular Inc. Tissue-removing catheter
US11819236B2 (en) 2019-05-17 2023-11-21 Medtronic Vascular, Inc. Tissue-removing catheter
JP2022540616A (ja) 2019-07-12 2022-09-16 シファメド・ホールディングス・エルエルシー 血管内血液ポンプならびに製造および使用の方法
US11654275B2 (en) 2019-07-22 2023-05-23 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
WO2021062265A1 (en) 2019-09-25 2021-04-01 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6132364A (en) * 1995-07-10 2000-10-17 H.D.S. Systems, Ltd. Heart assist system and method
CN201067570Y (zh) * 2007-08-01 2008-06-04 黄石安 左心室辅助导管装置
US20080306328A1 (en) * 2007-06-07 2008-12-11 Newcortec S.P.A. Duct for ventricular-assistance device
WO2012158437A2 (en) * 2011-05-13 2012-11-22 Mayo Foundation For Medical Education And Research Cannula apparatus and ventricular assist systems using the cannula apparatus

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3504662A (en) 1967-05-16 1970-04-07 Avco Corp Intra-arterial blood pump
US3592184A (en) 1969-12-16 1971-07-13 David H Watkins Heart assist method and catheter
US3692018A (en) 1970-02-11 1972-09-19 Robert H Goetz Cardiac assistance device
US4014317A (en) 1972-02-18 1977-03-29 The United States Of America As Represented By The Department Of Health, Education And Welfare Multipurpose cardiocirculatory assist cannula and methods of use thereof
US4301797A (en) 1977-05-12 1981-11-24 Pollack Charles N Balloon-tipped extracorporeal cannula apparatus and method for insertion of same
US4861330A (en) 1987-03-12 1989-08-29 Gene Voss Cardiac assist device and method
US5928132A (en) 1998-03-31 1999-07-27 Datascope Investment Corp. Closed chest intra-aortic balloon based ventricular assist device
US6136025A (en) 1999-07-27 2000-10-24 Barbut; Denise R. Endoscopic arterial pumps for treatment of cardiac insufficiency and venous pumps for right-sided cardiac support
US7914436B1 (en) 2006-06-12 2011-03-29 Abiomed, Inc. Method and apparatus for pumping blood
CN102488955B (zh) 2011-12-07 2013-06-05 湖南埃普特医疗器械有限公司 球囊导引导管及其制备方法
CN204147329U (zh) 2014-09-15 2015-02-11 湖南埃普特医疗器械有限公司 一种左心室辅助装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6132364A (en) * 1995-07-10 2000-10-17 H.D.S. Systems, Ltd. Heart assist system and method
US20080306328A1 (en) * 2007-06-07 2008-12-11 Newcortec S.P.A. Duct for ventricular-assistance device
CN201067570Y (zh) * 2007-08-01 2008-06-04 黄石安 左心室辅助导管装置
WO2012158437A2 (en) * 2011-05-13 2012-11-22 Mayo Foundation For Medical Education And Research Cannula apparatus and ventricular assist systems using the cannula apparatus

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11241571B2 (en) 2019-09-24 2022-02-08 Marvin Liu Implantable ventricular assist device
WO2023126204A1 (fr) 2021-12-31 2023-07-06 Bypa Medical Solutions Canule d'admission d'un dispositif d'assistance ou de suppléance du cœur
FR3131539A1 (fr) 2021-12-31 2023-07-07 Bypa Medical Solutions Canule d’admission d’un dispositif d’assistance ou de suppléance du cœur.
CN114796817A (zh) * 2022-05-26 2022-07-29 惠州市顺美医疗科技有限公司 超软颅内支持导管
CN114796817B (zh) * 2022-05-26 2023-03-24 惠州市顺美医疗科技有限公司 超软颅内支持导管

Also Published As

Publication number Publication date
US20160296683A1 (en) 2016-10-13
US9981078B2 (en) 2018-05-29

Similar Documents

Publication Publication Date Title
WO2016041220A1 (zh) 一种左心室辅助装置
US9504774B2 (en) Intraatrial ventricular assist device
US7524277B1 (en) Apex to aorta cannula assembly
CN204147329U (zh) 一种左心室辅助装置
CN104174078B (zh) 一种左心室辅助装置
JPWO2005011794A1 (ja) 大動脈内バルーンカテーテル
CN216603785U (zh) 一种介入式临时左心辅助装置
WO2020259358A1 (zh) 心脏冠状静脉血流阻断装置
WO2018133175A1 (zh) 一种可滑动多腔引流管
CN208726531U (zh) 一种具有金属网管的静脉插管
CN116271298A (zh) 一种房间隔穿刺双腔va-ecmo插管
CN215608125U (zh) 带球囊的静脉插管
CN210131233U (zh) 经皮左心引流管
CN210812926U (zh) 一种顺序球囊反搏式左心辅助装置
CN112915288A (zh) 带球囊的静脉插管
CN207136838U (zh) 左房肺动脉中心静脉联合测压导管
CN102553058A (zh) 新型逆向动脉插管
US20210187271A1 (en) A device for the ventricular emergency support
CN208448408U (zh) 一种高弹性和柔性兼具的双腔颈静脉插管
US20220280768A1 (en) Cannula for Endovascular Blood Circuit Support, Corresponding Assembly, Method and Cannula System
CN220877530U (zh) 一种心脏泵血导管辅助固定装置
CN116549762B (zh) 左心室辅助装置
CN219148995U (zh) 经皮介入式血泵
CN217612491U (zh) 一种主动脉内双球囊反搏导管及主动脉内球囊反搏装置
CN217015039U (zh) 经股静脉左房引流管

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 15022801

Country of ref document: US

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14902016

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 14902016

Country of ref document: EP

Kind code of ref document: A1