WO2021104449A1 - Ensemble conduit de circulation sanguine artérielle et système de circulation sanguine artérielle artificielle extracorporelle - Google Patents

Ensemble conduit de circulation sanguine artérielle et système de circulation sanguine artérielle artificielle extracorporelle Download PDF

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Publication number
WO2021104449A1
WO2021104449A1 PCT/CN2020/132213 CN2020132213W WO2021104449A1 WO 2021104449 A1 WO2021104449 A1 WO 2021104449A1 CN 2020132213 W CN2020132213 W CN 2020132213W WO 2021104449 A1 WO2021104449 A1 WO 2021104449A1
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Prior art keywords
section
blood
inner diameter
return
tube
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PCT/CN2020/132213
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English (en)
Chinese (zh)
Inventor
郭莉侠
祁远东
姜大为
丁海雁
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业聚医疗器械(深圳)有限公司
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Priority claimed from CN201911192276.3A external-priority patent/CN112843463A/zh
Priority claimed from CN201922091693.0U external-priority patent/CN212187286U/zh
Application filed by 业聚医疗器械(深圳)有限公司 filed Critical 业聚医疗器械(深圳)有限公司
Publication of WO2021104449A1 publication Critical patent/WO2021104449A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits

Definitions

  • the invention relates to medical equipment, in particular to an arterial blood circulation pipeline assembly and an artificial arterial blood extracorporeal circulation system.
  • an internal pump is used to pump arterial blood in the left ventricle into the aorta, so as to assume the pumping function of the heart.
  • the shortcomings of the pump in the body are its narrow passage and high speed, which can easily damage blood cells and cause hemolysis in a short time. Therefore, it cannot provide long-term support and can only support a few hours.
  • the structure of the internal pump is complicated, and power needs to be supplied to the internal body from outside the body, which increases the systemic risk.
  • This application provides an arterial blood circulation pipeline assembly and an artificial arterial blood extracorporeal circulation system containing the arterial blood circulation pipeline assembly, including the following embodiments:
  • Embodiment 1 An arterial blood circulation pipeline assembly, comprising: a left ventricular vascular access, the left ventricular vascular access is composed of a pigtail section, an extension section, a blood sampling port section, and a delivery section in sequence;
  • the length of the pig tail section is 20 mm or more, for example, 20 mm to 38 mm, a circle with a diameter of 7 mm to 13 mm is formed at one end of the left ventricular vascular tract, and the tube outer diameter of the pig tail section is 1-3 mm;
  • the length of the blood sampling port is 30mm to 70mm, and the inner diameter of the tube is 3mm to 6.5mm, for example, the inner diameter of the tube is 3.5mm to 6.4mm, the inner diameter of the tube is 4mm to 6.2mm, and the inner diameter of the tube is 4.5mm to 6.5mm.
  • the length of the delivery section is 700mm to 1400mm, the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm, the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm, the blood sampling port section and the delivery An angle of about 120 to about 170 degrees is formed between the segments;
  • the length of the extension section is 7 mm to 13 mm.
  • Embodiment 2 The arterial blood circulation pipeline assembly according to embodiment 1, wherein the inner diameter of the tube of the delivery section is 5.4 mm to 6.0 mm, and the length is 800 mm to 1100 mm. An angle of about 140 to about 160 degrees is formed between.
  • Embodiment 3 The arterial blood circulation pipeline assembly according to embodiment 1, further comprising a blood return pipeline, and the blood return pipeline includes a terminal section, a blood return port section, and a return section in sequence,
  • the length of the return section is 100mm to 1000mm
  • the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm
  • the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm
  • the inner diameter of the tube of the blood return hole section is 3 mm to 6.5 mm, for example, 3.5 mm to 6.4 mm, and the inner diameter of the tube is 4 mm to 6.2 mm, 4.5 mm to 6.5 mm, and the tube wall of the blood return hole section has a plurality of holes.
  • the length of the blood return hole section is 10 mm to 70 mm, for example, 30 mm to 70 mm;
  • the length of the end section is greater than or equal to 10 mm, the inner diameter of the tube changes from the inner diameter of the blood return port section to the end 1-3 mm, and the outer diameter of the tube changes from the outer diameter of the blood return port section to about 1 at the end. -3mm.
  • Embodiment 4 The arterial blood circulation tube assembly according to embodiment 3, wherein the length of the return section is 700 mm to 900 mm or 100 mm to 200 mm, and the inner diameter of the tube is 5.4 mm to 6.0 mm.
  • the infusion section is longer, and the infusion section can be set on the aorta, so that the blood taken from the left ventricle can normally enter the aorta to circulate. When it is not transferred back to the aorta, it is only necessary to transport the taken blood into the arterial blood vessel. Therefore, 100mm to 200mm can meet the requirements and can reduce the delivery pressure.
  • Embodiment 5 The arterial blood circulation pipeline assembly according to embodiment 3, wherein the blood return pipeline further comprises: a pump connector for return, the pump connector for return is used to connect to the outlet of an external pump, and the return
  • the inner diameter of the pipe at the interface of the pump joint is more than 1.1 times, 1.2 times, or 1.3 times the pipe inner diameter of the return section.
  • the pipe inner diameter at the interface of the pump joint for return is 7 mm or more.
  • Embodiment 6 The arterial blood circulation pipeline assembly according to embodiment 1, wherein the left ventricular blood collection tract further comprises: a pump connector for blood collection, and the pump connector for blood collection is connected to the delivery section.
  • the inner diameter of the tube at the interface of the blood taking pump connector is 1.1 times, 1.2 times or more, or 1.3 times the inner diameter of the delivery section,
  • the inner diameter of the tube at the interface of the blood sampling pump connector is 7 mm or more;
  • the left ventricular vascular access tract is not provided with a pump component; and the delivery section of the left ventricular vascular access tract is not provided with a side opening.
  • Embodiment 7 The arterial blood circulation pipeline assembly according to embodiment 1, wherein the area of each of the plurality of blood sampling holes is greater than or equal to 1 mm 2 , and the sum of the areas of the blood sampling holes is greater than or equal to the cross-sectional area of the pipeline of the transport section 1 time, preferably greater than or equal to 1.1 times the cross-sectional area of the pipeline in the conveying section, preferably greater than or equal to 1.2 times the cross-sectional area of the pipeline in the conveying section, preferably greater than or equal to 1.5 times the cross-sectional area of the pipeline in the conveying section.
  • the outer diameter of the extension section (12) changes from the outer diameter of the pigtail section (11) to the tube outer diameter of the blood sampling port section (13).
  • the blood sampling hole (131) is arranged in the front half of the blood sampling port section (13).
  • the blood sampling hole (131) with more than 80 area% is provided in the front half of the blood sampling port section (13).
  • the opening ratio of the blood sampling port section (13) in the longitudinal direction and the circumferential direction is less than or equal to 75%, less than or equal to 50%, for example, less than or equal to 40%, for example, less than or equal to 30%.
  • Embodiment 8 An artificial arterial blood extracorporeal circulation system, comprising: a left ventricular blood vessel taking tract, an extracorporeal pump and a blood return pipeline,
  • the inner diameter of the input and output pipes of the extracorporeal pump is greater than the inner diameter of the left ventricular vascular access, for example, the inner diameter of the input and output pipes of the extracorporeal pump is more than 1.1 times the inner diameter of the delivery section of the left ventricular vascular access , 1.2 times or more, or 1.3 times or more.
  • Embodiment 9 The artificial arterial blood extracorporeal circulation system according to embodiment 8, wherein the inner diameter of the input and output pipes of the extracorporeal pump is greater than or equal to 7.00 mm.
  • Embodiment 10 The artificial arterial blood extracorporeal circulation system according to embodiment 8, wherein the extracorporeal pump is a centrifugal pump, a squeeze pump or a roller pump, and can output 100 to 200 mm or 100 to 300 mm Hg pressure.
  • the extracorporeal pump is a centrifugal pump, a squeeze pump or a roller pump, and can output 100 to 200 mm or 100 to 300 mm Hg pressure.
  • Embodiment 11 The artificial arterial blood extracorporeal circulation system according to embodiment 8, wherein
  • the left ventricular blood vessel sampling tract includes a pigtail section, an extension section, a blood sampling port section, and a delivery section in sequence;
  • the length of the pigtail section is 20mm or more, for example 20mm to 38mm, a circle with a diameter of 7mm to 13mm is formed at one end of the pipe, and the pipe outer diameter of the pigtail section is 1-3mm;
  • the length of the blood sampling port section is 30 mm to 70 mm, the tube inner diameter is 3 mm to 6.5 mm, for example, 3.5 mm to 6.4 mm, and the tube inner diameter is 4 mm to 6.2 mm, 4.5 mm to 6.5 mm.
  • the length of the delivery section is 800mm to 1200mm
  • the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm
  • the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm
  • the blood sampling port section and the delivery An angle of about 120 to about 170 degrees is formed between the segments;
  • the length of the extension section is 7 mm to 13 mm, and the inner diameter of the tube varies from the inner diameter of the pigtail section to the inner diameter of the blood sampling section;
  • the blood return pipeline sequentially includes: a terminal section, a blood return port section and a return section,
  • the length of the return section is 100mm to 1000mm
  • the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm
  • the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm
  • the length of the blood return hole section is 10 mm to 70 mm, for example, 30 mm to 70 mm, the inner diameter of the tube is 3 mm to 6.5 mm, for example, 3.5 mm to 6.4 mm, and the inner diameter of the tube is 4 mm to 6.2 mm, 4.5 mm to 6.5 mm.
  • the length of the end section is greater than or equal to 10 mm, the inner diameter of the tube changes from the inner diameter of the blood return port section to the end 1-3 mm, and the outer diameter of the tube changes from the outer diameter of the blood return port section to about 1 at the end. -3mm.
  • the application also includes an artificial arterial blood extracorporeal circulation system, which includes the arterial blood circulation pipeline assembly according to any one of the foregoing embodiments and an extracorporeal pump (3).
  • the present application also includes a method for treating heart disease, which includes inserting the left ventricle aspiration tract (1) in the subject of any one of the foregoing embodiments through a femoral artery of a patient under the guidance of a guide wire Until the pigtail section (11), extension section (12), and blood sampling port section (13) enter the left ventricle of the patient.
  • the method further includes inserting the blood return tube (2) into the femoral artery on the other side of the patient until the end section (21) and the blood return port section (22) enter the patient's femoral artery Or the aorta.
  • the method further includes connecting the left ventricular blood vessel (1) and the blood return pipeline (2) with an extracorporeal pump, so that the extracorporeal pump is taken by the left ventricle.
  • the blood vessel (1) draws blood from the left ventricle of the patient, and returns the drawn blood to the arterial blood vessel of the patient through the blood return pipe (2).
  • the arterial blood circulation pipeline assembly and an artificial arterial blood extracorporeal circulation system including the arterial blood circulation pipeline assembly disclosed in the present application compensate the heart's pumping function by pumping the blood of the left ventricle into the artery, and provide in treatment Enough blood, to win enough treatment time for patients.
  • Figure 1 shows the left ventricle to take the blood vessel
  • Figure 2 shows the blood return pipeline
  • Figure 3 shows the artificial arterial blood extracorporeal circulation system of embodiment 1;
  • Figure 4 shows the artificial arterial blood extracorporeal circulation system of embodiment 2
  • Figure 5 is a schematic diagram of the artificial arterial blood extracorporeal circulation system of this embodiment during treatment
  • Fig. 6 is a dimension drawing of the left ventricle vascular access, which adds the meaning of each size of the left ventricular vascular access on the basis of Fig. 2.
  • Blood return pipeline-2 terminal section-21, return blood port section-22, return blood port-221, return section-23, return pump connector-24;
  • the length of the pigtail section-L5; the diameter of the circle formed by the pigtail section-L1; the length of the extension section-L2; the length of the blood sampling port-L3; the length of the conveying section-L4; the formation between the blood sampling port and the conveying section The angle- ⁇ .
  • an artificial arterial blood extracorporeal circulation system which includes a left ventricular blood vessel taking tract, an extracorporeal pump and a blood return pipeline, wherein the outlet of the blood taking tract is connected to the inlet of the extracorporeal pump, and The inlet of the blood return pipeline is connected to the outlet of the extracorporeal pump.
  • the inner diameter of the input and output pipelines of the extracorporeal pump is larger than the inner diameter of the left ventricular blood vessel.
  • the inner diameter of the input and output pipelines of the extracorporeal pump is The left ventricle takes more than 1.1 times, more than 1.2 times, or more than 1.3 times the inner diameter of the delivery section of the vascular tract.
  • the inner diameter of the input and output pipeline of the pump in the artificial arterial blood extracorporeal circulation system is larger than the inner diameter of the left ventricular blood vessel, which allows the pump to use a common centrifugal pump known in the prior art ( centrifugal pump, extrusion pump, or roller pump, which reduces the cost of equipment.
  • the inner diameter of the pipe can be thicker, so that when pumping blood, the speed can be lower to achieve the required value.
  • the blood flow greatly reduces the risk of hemolysis.
  • the pump is outside the body, and there is no need to supply power from outside the body to the body, reducing systemic risks. Even if the pump fails, it can be replaced immediately, so it can provide patients with longer-term external support , Provide doctors with longer medical time.
  • the artificial arterial blood extracorporeal circulation system of the present invention can provide patients with extracorporeal arterial blood circulation support for more than 48 hours or even longer.
  • the inner diameter of the input and output pipes of the extracorporeal pump is greater than or equal to 7.00 mm, for example, 8 mm or greater, 10 mm or greater, 12 mm or greater.
  • the blood pressure of the human body is usually 100 to 200 mmHg
  • the blood volume requirement is usually 3 to 6 liters
  • the blood volume requirement can be as low as 2.0 to 2.5 liters to maintain basic survival needs. It is sufficient to use pipelines within this range.
  • such a thick tube cannot be implanted in the body, and the inner diameter limit of the arteries in the body can hardly be reached, so the tube can only be installed outside the body.
  • the extracorporeal pump in the artificial arterial blood extracorporeal circulation system, is a centrifugal pump, a squeeze pump, or a roller pump, and can output 100 to 200 mm Hg or 100 to 300 mm Hg. pressure.
  • the left ventricular blood vessel sampling tract includes a pig tail section, an extension section, a blood sampling port section, and a delivery section in sequence;
  • the length of the pigtail section (L5 in Figure 6) is more than 20mm, for example 20mm to 38mm, a circle with a diameter (L1 in Figure 6) of 7mm to 13mm is formed at one end of the pipe, and the pipe outer diameter of the pigtail section 1-3mm;
  • the length of the blood sampling port section (L3 in FIG. 6) is 30 mm to 70 mm, the inner diameter of the tube is 4.5 mm to 6.5 mm, and the tube wall of the blood sampling port section has multiple blood sampling holes;
  • the length of the delivery section (L4 in Figure 6) is 800mm to 1200mm, the inner diameter of the tube is 4.5mm to 6.5mm, and an angle of about 120 to about 170 degrees is formed between the blood sampling port section and the delivery section ( ⁇ in Figure 6);
  • the length of the extension section (L2 in FIG. 6) is 7 mm to 13 mm (or 8 mm to 12 mm), and the inner diameter of the tube is optionally changed from the inner diameter of the pigtail section to the inner diameter of the blood sampling section;
  • the blood return pipeline sequentially includes: a terminal section, a blood return port section and a return section,
  • the length of the return section is 100mm to 1000mm, and the inner diameter of the tube is 4.5mm to 6.5mm,
  • the length of the blood return hole section is 30 mm to 70 mm, the inner diameter of the tube is 4.5 mm to 6.5 mm, and the tube wall of the blood return hole section has multiple blood return holes;
  • the length of the end section is greater than or equal to 10 mm, optionally the inner diameter of the tube is from the inner diameter of the blood return port section to the end of 1-3 mm, and optionally the outer diameter of the tube is the outer diameter of the tube from the blood return port section Change to about 1-3mm at the very end.
  • the left ventricular vascular access channel usually enters the human body through the heart from one side of the thigh, and the blood return channel can enter the arteries of the human body through the other side of the thigh.
  • the pigtail tube is mainly used to determine the position of the center of the left ventricle. It is bent into a circle to avoid damage to the heart.
  • the diameter of the circle that the heart can usually accommodate is 7-12mm, so the pigtail It is more appropriate for the outer diameter of the section to be 1-3mm, that is, 3F to 10F.
  • the pigtail section is thin, but not too thin, too thin will damage the heart, and not too thick, too thick to bend into a circle with a diameter of 7-13mm (or 8-12mm).
  • the extension section is connected with the pigtail section, and the other end is connected with the blood sampling port section.
  • the main function of this section is to provide an extension from the pigtail section to the blood sampling port section.
  • the inner diameter of the extension section changes from the inner diameter of the pigtail section to the tube inner diameter of the blood sampling port section.
  • the outer diameter of the extension section changes from the outer diameter of the pigtail section to the outer tube outer diameter of the blood sampling port section.
  • the blood sampling port section is a pipe that provides the blood sampling hole for the system when the system is working.
  • the left ventricle In the left ventricle where this section is located, the left ventricle has a wider space and is suitable for blood sampling.
  • the length of the blood sampling port segment is 30 mm to 70 mm, and this length is compatible with the size of the heart.
  • the inner diameter of the tube is 4.5mm to 6.5mm (or 4.7mm to 6.3mm). This range corresponds to the blood pressure between 100mmHg and 300mmHg.
  • the entire length of the left ventricular vascular tract provides the necessary The inner diameter of the tube required for the blood flow (usually 3-6 liters/min). In a preferred embodiment, the inner diameter of the tube of the blood sampling port is 5.4 mm to 6.0 mm.
  • the tube wall of the blood sampling port section is provided with a plurality of blood sampling holes.
  • the function of the blood sampling hole is to provide an entrance for blood to enter the pipe.
  • the shape, size, and number of blood sampling holes are not particularly limited, as long as they can provide an inlet for blood.
  • the area of each blood sampling hole can be greater than or equal to 1 mm 2 .
  • the blood sampling hole with an area of more than 80% is provided in the first half of the blood sampling port section.
  • the blood sampling hole is provided in the front half of the blood sampling port section. This is because the first half of the blood sampling port is on the left ventricular outflow tract.
  • the blood sampling here is closer to the feeling of blood flowing out of the left ventricle, while the second half of the blood sampling port is close to the heart valve. If a blood sampling port is set It may affect the work of heart valves.
  • the blood sampling hole may be a plurality of elongated holes arranged longitudinally along the extension direction of the pipeline, and the holes may be rectangular or oblong.
  • the shape of each blood sampling hole can be independently selected from a circle, a square, an oval, a triangle, and an irregular shape.
  • the blood sampling hole can be symmetrically arranged on the pipeline.
  • the sum of the area of the blood sampling hole can be greater than or equal to 1 time of the cross-sectional area of the pipeline of the conveying section, preferably greater than or equal to 1.1 times of the cross-sectional area of the pipeline of the conveying section, preferably greater than or equal to the conveying section.
  • 1.2 times the cross-sectional area of the pipeline preferably greater than or equal to 1.5 times the cross-sectional area of the pipeline in the conveying section.
  • the opening rate of the blood taking port segment in the longitudinal and circumferential directions is less than or equal to 75%, less than or equal to 50%, preferably less than or equal to 40%, preferably less than or equal to 30%.
  • the longitudinal aperture ratio mentioned here refers to the maximum value of the ratio of the length of the opening in each longitudinal direction on the surface of the blood sampling port segment to the total length of the opening area.
  • the total length of the opening area refers to the longitudinal distance from the most distal opening to the nearest opening.
  • the hoop opening ratio mentioned here refers to the maximum value of the ratio of the hoop length to the circumference of the openings on the surface of the blood taking port section in the upward direction of each circle on the surface of the blood taking port section.
  • the longitudinal and circumferential opening rates are low so that the blood sampling hole of the blood sampling port does not significantly reduce the strength of the blood sampling port.
  • the entire left ventricular blood sampling tract can be made of softer materials, and there is no need to take blood.
  • the mouth section can be used if it is specially strengthened (for example, made of hard or made of metal materials).
  • the whole pipe is soft and can minimize the damage to the body during the process of entering the human body. The harder pipe may cause damage to the blood vessel in the process of passing through the blood vessel, which brings risks to the operation.
  • the materials used to prepare each component of the product of this application are not particularly limited, and those skilled in the art can make selections according to actual needs.
  • the product of this application can be made of metal, polymer or composite materials.
  • Suitable metals may include cobalt chromium, stainless steel, MP35N, nickel titanium, etc., and metal alloys such as shape memory materials, such as nickel titanium alloys.
  • Suitable polymer materials may include aliphatic polyether polyurethane, polyamide, low-density polyethylene (LDPE), polypropylene or polymer blends, and the like.
  • Suitable composite materials may include a composite of polymer and metal, such as a pipe wall formed by a mixture of metal and polymer or a pipe wall formed by abutting metal (such as a wire mesh) and polymer.
  • the materials used in at least a part of the components of the product of the present application may include radiopaque materials, for example, a composition including a filler that is impermeable to radiation.
  • Those skilled in the art can determine the hardness of the material used to prepare the product of the present application according to actual needs, which can include polymers whose hardness ranges from soft rubber-like materials to hard composite polymers or plastics using
  • the extension section is provided with an extension section opening, and the extension section opening can be used to assist in taking blood.
  • the setting of the openings in the extension section is not particularly limited, and those skilled in the art can make selections according to actual needs.
  • the inner diameter of the blood sampling port section (13) is smaller than the inner diameter of the delivery section (14). This setting method is to leave more space for blood to flow in. Experiments have proved that this design method is particularly suitable for narrow spaces in blood vessels.
  • the opening ratio of the blood return hole section in the longitudinal direction and the circumferential direction is less than or equal to 75%, less than or equal to 50%, preferably less than or equal to 40%, preferably less than Equal to 30%.
  • the longitudinal aperture ratio mentioned here refers to the maximum value of the ratio of the length of the opening in each longitudinal direction on the surface of the blood return hole segment to the total length of the opening area.
  • the total length of the opening area refers to the longitudinal distance from the most distal opening to the nearest opening.
  • the hoop opening ratio mentioned here refers to the maximum value of the ratio of the hoop length to the circumference of the opening at the surface of each hoop section in the upper hoop section.
  • the longitudinal and circumferential opening rates are low so that the blood return hole of the blood return hole section will not significantly reduce the strength of the blood return hole section.
  • the entire blood return pipeline can be made of softer materials without special reinforcement in the blood return hole section (for example, it can be used if it is made of hard material or made of metal materials.
  • the whole pipe is soft and can cause minimal damage to the body during the process of entering the human body.
  • the harder pipe may cause damage to the blood vessel in the process of passing through the blood vessel, which brings risks to the operation.
  • the left ventricular blood vessel taking tract further includes: a blood taking pump connector, the blood taking pump connector is connected to the delivery section, and is used to connect the left ventricle blood taking tract to an external pump.
  • the inlet is connected; the left ventricular vascular tract is not provided with a pump component; and the left ventricular vascular tract is not provided with a side opening in the delivery section.
  • the inner diameter of the tube at the interface of the blood sampling pump connector is more than 1.1 times, more than 1.2 times, or more than 1.3 times the inner diameter of the tube of the delivery section, for example, the interface of the blood sampling pump connector
  • the inner diameter of the pipe is 7 mm or more, for example, 8 mm or more, 9 mm or more, or even 10 mm or more.
  • the pump connector for blood collection is usually made of a different material from the pipe, for example, made of polycarbonate material, which can ensure a better connection effect.
  • the pigtail section, extension section, blood sampling port section, and delivery section can be made of polyamide material (such as nylon 12, nylon 66, etc.), and a layer of fine stainless steel wire mesh is usually arranged on the inside of the tube to enhance the strength of the pipeline.
  • the pipeline assembly of the present application is set to be flexible and can automatically conform to the curvature of the blood vessel without causing abrupt bending points and affecting the flow of blood in the pipeline.
  • the preset bending angle can be set according to the structure of the blood vessel in the body, so that the pipeline assembly can better fit the direction of the blood vessel.
  • each section of the pipeline can also adopt different pipeline materials and structures according to actual needs.
  • the blood sampling port section adopts a three-layer structure, including a memory metal layer surrounded by two polymer layers, to ensure that blood is taken during use.
  • the shape of the mouth is not damaged, and no metal parts are exposed, which reduces the damage to blood cells and reduces the occurrence of hemolysis.
  • the structure of the blood sampling port segment has the disadvantages of being relatively fragile and easy to deform. If this three-layer structure is adopted, this shortcoming can be overcome.
  • the left ventricular vascular access tract described in this application can also partially or fully adopt a three-layer structure of inner layer, middle layer and outer layer, wherein the inner layer is made of polytetrafluoroethylene, the middle layer is made of steel mesh or spring, and the outer layer is made of nylon.
  • the inner layer of PTFE film has a low coefficient of friction, good biocompatibility, good lubricating performance, and will not damage blood cells.
  • the middle layer of steel mesh or spring can make it not deformed during use and has a good radial direction. Compression resistance, the outer layer is a nylon layer with good plasticity, and has good tracking and compliance in the blood vessel.
  • the left ventricular vascular access tract is not provided with a pump component; and the delivery section of the left ventricular vascular access tract is not provided with a side opening. This makes the equipment that enters the human body relatively simple, which greatly reduces the systemic risk, and because the pump is set outside the body, it is possible to select a more suitable pump for blood delivery according to needs, reducing the risk of hemolysis.
  • the left ventricular vascular access and the blood return pipeline of the present application can be independently covered with a protective cover to provide a smooth outer surface without reducing the flexibility of the distal tube portion.
  • the sheath can be made of polymer, for example, by surrounding the tube wall with a multi-layer co-extruded polymer tubular structure and thermally shrinking the tube structure, or coating the tube wall by a dip coating process.
  • the polymer sheath material can be nylon, polyether block amide, PTFE, FEP, PFA, PET, PEEK, etc.
  • at least part or all of the left ventricular blood collection tract and the blood return pipeline may be coated with a hydrophilic polymer coating to enhance traceability.
  • the hydrophilic polymer coating may include polyelectrolyte and/or non-ionic hydrophilic polymer, wherein the polyelectrolyte polymer may include poly(acrylamide-acrylic acid) salt, poly(methacrylamide-acrylic acid) salt, poly( Acrylamide-methacrylic acid) salt, etc.
  • the non-ionic hydrophilic polymer may be poly(lactam), such as polyvinylpyrrolidone (PVP), polyurethane, homopolymers and copolymers of acrylic acid and methacrylic acid, Polyvinyl alcohol, polyvinyl alcohol, maleic anhydride-based copolymer, polyester, hydroxypropyl cellulose, heparin, dextran, polypeptide, etc. See U.S. Patent Nos. 6458867 and 8871869, which are incorporated into this application by reference.
  • the delivery section is used to deliver blood from the left ventricle to the outside of the body.
  • the length is 700mm to 1400mm
  • the inner diameter of the tube is 3mm to 6.5mm, for example, 4.5mm to 6.5mm (or 4.7mm to 6.3mm)
  • the blood sampling port section and the delivery section form about 120 to about 170 degrees ( Or about 130 to about 160 degrees).
  • the length can meet the length from the root of the thigh to the heart. The length cannot be too short, it cannot reach the heart, the length cannot be too long, and the too long length increases the resistance too much, so that the blood flow is reduced and cannot reach 3-6 liters.
  • the bending angle conforms to the angular relationship between the heart and the aorta.
  • the inner diameter of the tube of the delivery section is 5.4 mm to 6.0 mm, and the length is 800 mm to 1100 mm, and an angle of about 140 to about 160 degrees is formed between the blood sampling port section and the delivery section. Under this inner diameter, it can better meet the blood supply needs of adults.
  • the angle of about 140 to about 160 degrees is also a better fit angle between the left ventricle and the aorta.
  • the blood return pipeline is used to return blood to the arteries with the help of the power of the pump.
  • the return pipeline includes three sections, a terminal section, a blood return port section, and a return section.
  • the terminal section is mainly used to guide the blood return pipeline to a target location by means of a guide wire.
  • a guide wire There is no particular restriction on the inner diameter of the end section of the tube, as long as the inner tube can be easily provided with a guide wire so that the entire tube can be inserted into the human body along the guide wire.
  • the inner diameter of the tube of the blood return hole section is 4.5 mm to 6.5 mm, and the tube wall of the blood return hole section has a plurality of blood return holes.
  • the end point length of the blood return hole may be 30 mm to 70 mm.
  • the blood return port segment is similar to the blood taking port segment, so all the parameters can be similarly applied.
  • the inner diameter of the tube of the blood return port is 5.4 mm to 6.0 mm.
  • the tube wall of the blood return hole section has a plurality of holes, which are called the blood return hole.
  • the function of the blood return hole was to provide an entrance for blood to enter the artery.
  • the size and number of the blood return holes are not particularly limited, as long as they can provide an inlet for blood.
  • each blood return hole can be greater than or equal to 1 mm 2 .
  • the blood return hole may be a plurality of elongated holes arranged longitudinally along the extension direction of the pipeline, and the holes may be rectangular or oblong.
  • the blood return hole can be symmetrically arranged on the pipeline.
  • the sum of the area of the blood return hole can be greater than or equal to 1 time of the cross-sectional area of the pipeline of the return section, preferably greater than or equal to 1.1 times the cross-sectional area of the pipeline of the return section, preferably greater than It is equal to 1.2 times the cross-sectional area of the pipeline in the return section, preferably greater than or equal to 1.5 times the cross-sectional area of the pipeline in the return section.
  • a terminal section opening is provided in the terminal section, and the terminal section opening can be used to assist in returning blood.
  • the setting of the openings in the end section is not particularly limited, and those skilled in the art can make selections according to actual needs.
  • the inner diameter of the blood return port section is smaller than the inner diameter of the return section. This setting method is to leave more space for the blood to flow out. Experiments have proved that this design method is particularly suitable for the narrow space in the blood vessel.
  • the length of the return section is 100mm to 1000mm, and the length of the return section can be changed in a larger range, because the return section can be wider according to the target position of the return. Changes within the scope. For example, when it only needs to be infused to the aortic vessels closer to the inner thigh, the length of the infusion segment can be about 100mm to 200mm. In this case, the infused arterial blood can still reach all parts of the body, and the delivery pressure is relatively high. low. In an ideal situation, the return tube can be 700mm to 900mm long. In this way, the blood return port can be placed on the aorta near the left ventricle, and the arterial blood passes through a normal way similar to the normal way the heart provides pumping power. Flowing in the blood vessels can achieve better blood circulation.
  • the blood return pipeline further includes: a pump connector for return, and the pump connector for return is used to connect with an outlet of an external pump.
  • the inner diameter of the pipe at the interface of the pump connector for return is more than 1.1 times, more than 1.2 times, or more than 1.3 times the inner diameter of the pipe of the return section, for example, at the interface of the pump connector for return
  • the inner diameter of the pipe is 7mm or more.
  • Pump joints for return are usually made of different materials from the pipes, such as polycarbonate materials, which can ensure a better connection effect.
  • the end section, the blood return hole section, and the return section can be made of polyamide material (such as nylon 12, nylon 66, etc.), and a layer of fine stainless steel wire mesh is usually arranged on the inside of the tube to enhance the strength of the tube.
  • the method and materials for preparing the product of the present invention are not particularly limited, and other methods and materials known in the art for preparing pipes passing through the human body can be used for preparation.
  • a continuous extrusion process is used to prepare the left ventricular blood collection tract and blood return pipe, both of which are made of a composite structure reinforced by a nylon outer skin and a stainless steel wire mesh inner layer, and the wall thickness of the pipe is about 0.3 mm.
  • the terms “external pump” and “external pump” have the same meaning and can be used interchangeably to refer to a pump device that is set outside the patient's body to provide power for blood circulation.
  • the pump described can be a common centrifugal pump, squeeze pump or roller pump.
  • the pump assembly of this application can be reused, while the pipeline assembly is a consumable during surgery and is usually sold as an independent commodity. Therefore, this application also includes the following content:
  • An arterial blood circulation pipeline assembly comprising: a left ventricle vascular access (1), the left ventricular vascular access (1) consists of a pigtail section (11), an extension section (12), and a blood sampling port (13) in sequence ), and the conveying section (14);
  • the length of the pigtail section (11) is 20mm or more, such as 20mm to 38mm, a circle with a diameter of 7mm to 13mm is formed at one end of the left ventricular vascular access (1), and the tube outer diameter of the pigtail section (11) 1-3mm;
  • the length of the blood sampling port section (13) is 30mm to 70mm, the inner diameter of the tube is 4.5mm to 6.5mm, and the tube wall of the blood sampling port section (13) has multiple holes, which are called blood sampling holes (131 );
  • the length of the conveying section (14) is 700mm to 1400mm, the inner diameter of the tube is 4.5mm to 6.5mm, and the blood sampling port section (13) and the conveying section (14) are formed between about 120 to about 170 degrees. angle;
  • the length of the extension section (12) is 7 mm to 13 mm.
  • the inner diameter of the tube of the delivery section (14) is 5.4mm to 6.0mm, and the length is 800mm to 1100mm.
  • An angle of about 140 to about 160 degrees is formed between the conveying sections (14).
  • the arterial blood circulation pipeline assembly further includes a blood return pipeline (2), and the blood return pipeline (2) in turn includes: a terminal section (21), a blood return port section (22), and a return section (twenty three),
  • the length of the return section (23) is 100mm to 1000mm, and the inner diameter of the pipe is 4.5mm to 6.5mm,
  • the inner diameter of the tube of the blood return hole section (22) is 4.5mm to 6.5mm, and the tube wall of the blood return hole section (22) has a plurality of holes, which are called the blood return hole (221).
  • the blood return hole (221) The length of the hole section (22) is 30mm to 70mm;
  • the length of the end section (21) is greater than or equal to 10 mm.
  • the length of the return section (23) is 700 mm to 900 mm or 100 mm to 200 mm, and the inner diameter of the tube is 5.4 mm to 6.0 mm.
  • the blood return pipeline (2) further includes: a pump connector (24) for return, and the pump connector (24) for return is used to communicate with the body
  • the outlet of the pump (3) is connected, and the inner diameter of the pipe at the interface of the return pump connector (24) is more than 1.1 times, more than 1.2 times, or more than 1.3 times the inner diameter of the pipe of the return section (23), for example,
  • the inner diameter of the pipe at the interface of the return pump connector (15) is 7mm or more.
  • the left ventricular blood tract (1) further includes: a pump connector (15) for blood collection, and the pump connector (15) for blood collection is connected to the The delivery section (14) is connected to connect the left ventricular blood vessel (1) with the inlet of the extracorporeal pump (3), and the inner diameter of the tube at the interface of the blood pump connector (15) is The inner diameter of the tube of the delivery section (14) is more than 1.1 times, more than 1.2 times, or more than 1.3 times, for example, the inner diameter of the tube at the interface of the blood pump connector (15) is more than 7 mm;
  • the left ventricular vascular access tract (1) is not provided with a pump component; and the delivery section (14) of the left ventricular vascular access (1) is not provided with a side opening. In some embodiments, no valve assembly is provided on the left ventricular vascular access tract (1). This is to reduce blood circulation resistance as much as possible, and the blood flow direction can be completely controlled by an extracorporeal pump.
  • the simplest left ventricle vascular access (1) can provide an optimal blood circulation channel.
  • the area of each of the plurality of blood sampling holes (131) is greater than or equal to 1 mm 2 , and the sum of the areas of the blood sampling holes (131) is greater than or equal to 1 time of the pipe cross-sectional area of the conveying section (14), preferably greater than or equal to 1.1 times the pipe cross-sectional area of the conveying section (14), preferably greater than or equal to 1.2 times the pipe cross-sectional area of the conveying section (14) , Preferably greater than or equal to 1.5 times the cross-sectional area of the pipeline of the transport section (14).
  • the left ventricle blood sampling tract (1) is provided with a visualization indicator, specifically, it can be set at or near the junction of the delivery section (14) and the blood sampling port (13), for example Set on the pipe wall.
  • a visualization indicator specifically, it can be set at or near the junction of the delivery section (14) and the blood sampling port (13), for example Set on the pipe wall.
  • Three visualization indicators can be set at the connection between the conveying section (14) and the blood sampling hole section (13), and at 20-30mm before and after the connection, so as to help the doctor judge the set
  • the left ventricle takes the posture of the blood vessel (1) in the patient's body.
  • the working process and principle of the artificial arterial blood extracorporeal circulation system of the present application are: exhaust the clean artificial arterial blood extracorporeal circulation system and fill it with heparin saline; insert the first guide wire through the puncture site of one femoral artery of the patient The aorta, and finally reach the left ventricle, the left ventricle vascular access (1) is guided into the left ventricle under the guidance of the guide wire.
  • the visualization indicator can be used to assist in judging the position reached by the left ventricular vascular access (1), and take it out Guide wire; penetrate the second guide wire through the femoral artery on the other side to reach the femoral artery or aorta, and return the blood to the pipeline (2) under the guidance of the second guide wire to reach the femoral artery or the aorta Start the external pump device, under the action of the pump, the blood in the left ventricle is continuously drawn out through the left ventricular vascular tract (1) and returned to the femoral artery or aorta through the blood return pipeline (2).
  • the device can reduce the pressure on the heart; when the power of the pump is large and the speed of drawing blood is sufficient, the arterial blood circulation provided by the device is The amount can reach the blood supply that the patient usually needs, so as to replace the left ventricle to directly supply blood to the artery.
  • An arterial blood circulation pipeline assembly comprising: a left ventricle vascular access tract (1), the left ventricular vascular access (1) sequentially includes: a protection section, a blood sampling port section (13), and a delivery section (14);
  • the protective section has a tube end formed of a flexible shape and/or a flexible material for avoiding damage to the left ventricle during operation;
  • the tube wall of the blood sampling port section (13) has a plurality of holes, that is, the blood sampling hole (131);
  • the length of the conveying section (14) is 700mm to 1400mm, the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm, and the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm,
  • an angle of about 120 to about 170 degrees is formed between the blood sampling port section (13) and the delivery section (14).
  • the protection section includes a pigtail section (11) and an extension section (12);
  • the pigtail section (11), as the end of the blood vessel, has an outer diameter of 1 mm to 3 mm, and a circle with a diameter of 7 mm to 13 mm is formed at one end of the left ventricular blood vessel removal channel (1);
  • the length of the blood sampling port (13) is 30mm to 70mm
  • the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm
  • the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm
  • the extension section (12) connects the pigtail section (11) and the blood sampling port section (13).
  • protection section is not limited, as long as it can avoid damage to the left ventricle during operation. Any tube end formed of a flexible shape and/or flexible material can be used as the protection section. Flexible materials include various plastics, foam products, etc., and flexible shapes include the pigtail section described in this application.
  • the length of the pigtail section is more than 20mm, for example 20mm to 38mm,
  • the length of the extension section (12) is 7 mm to 13 mm.
  • the length of the return section (23) is 100mm to 1000mm
  • the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm
  • the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm
  • the inner diameter of the tube of the blood return hole section (22) is 3mm to 6.5mm, such as 3.2mm to 5.0mm, for example 4.5mm to 6.5mm, and the tube wall of the blood return hole section (22) has multiple holes, that is, blood return
  • the hole (221), optionally, the length of the blood return hole section (22) is 30mm to 70mm;
  • the length of the end section (21) is greater than or equal to 10 mm.
  • the inner diameter of the blood return port section (22) is smaller than the inner diameter of the return section (23).
  • Aspect 6 The arterial blood circulation pipeline assembly according to aspect 5, wherein the length of the return section (23) is 700 mm to 900 mm or 100 mm to 200 mm, and the inner diameter of the tube is 5.4 mm to 6.0 mm.
  • Aspect 7 The arterial blood circulation pipeline assembly according to aspect 5, wherein the blood return pipeline (2) further comprises: a pump connector (24) for return, and the pump connector (24) for return is used to communicate with the The outlet connection of the extracorporeal pump (3), the inner diameter of the pipe at the interface of the return pump connector (24) is more than 1.1 times, more than 1.2 times, or more than 1.3 times the inner diameter of the pipe of the return section (23), for example
  • the inner diameter of the pipe at the interface of the return pump connector (15) is 7mm or more.
  • the left ventricular blood vessel taking tract (1) further comprises: a blood taking pump connector (15), the blood taking pump connector (15) and The delivery section (14) is connected to connect the left ventricular blood vessel (1) with the inlet of the extracorporeal pump (3), and the inner diameter of the tube at the interface of the blood pump connector (15) is
  • the inner diameter of the tube of the delivery section (14) is more than 1.1 times, more than 1.2 times, or more than 1.3 times, for example, the inner diameter of the tube at the interface of the blood sampling pump connector (15) is more than 7 mm;
  • the left ventricular vascular access tract (1) is not provided with a pump component; and the delivery section (14) of the left ventricular vascular access (1) is not provided with a side opening.
  • Aspect 9 The arterial blood circulation pipeline assembly according to aspect 1, wherein the area of each of the plurality of blood sampling holes (131) is greater than or equal to 1 mm 2 , and the sum of the areas of the blood sampling holes (131) is greater than or equal to 1 time of the pipe cross-sectional area of the conveying section (14), preferably greater than or equal to 1.1 times the pipe cross-sectional area of the conveying section (14), preferably greater than or equal to 1.2 times the pipe cross-sectional area of the conveying section (14) , Preferably greater than or equal to 1.5 times the cross-sectional area of the pipeline of the transport section (14).
  • Aspect 10 The arterial blood circulation pipeline assembly according to aspect 2, wherein the outer diameter of the extension section (12) changes from the outer diameter of the pigtail section (11) to the tube outer diameter of the blood sampling port section (13).
  • Aspect 11 The arterial blood circulation pipeline assembly according to aspect 1, wherein the blood sampling hole is arranged in the front half of the blood sampling port section.
  • Aspect 12 The arterial blood circulation pipeline assembly according to aspect 1, wherein more than 80 area% of the blood sampling hole is arranged in the front half of the blood sampling port section.
  • Solution 13 The arterial blood circulation pipeline assembly according to any one of the solutions 1 to 12, wherein the opening ratio of the blood sampling port section (13) in the longitudinal and circumferential directions is less than or equal to 75%, and less than or equal to 50% , For example, less than or equal to 40%, for example, less than or equal to 30%.
  • Scheme 14 An artificial arterial blood extracorporeal circulation system, comprising: the arterial blood circulation pipeline assembly according to any one of schemes 1 to 13, and an extracorporeal pump (3).
  • Solution 15 The artificial arterial blood extracorporeal circulation system according to claim 14, wherein the inner diameter of the input and output pipelines of the extracorporeal pump (3) is greater than or equal to 7.00 mm.
  • Solution 16 The artificial arterial blood extracorporeal circulation system according to solution 14, wherein the extracorporeal pump (3) is a centrifugal pump, a squeeze pump or a roller pump, and can output 100 to 200 mmHg or 100 to 300 mmHg The pressure of the column.
  • the extracorporeal pump (3) is a centrifugal pump, a squeeze pump or a roller pump, and can output 100 to 200 mmHg or 100 to 300 mmHg The pressure of the column.
  • Scheme 17 A method for the treatment of heart disease, which comprises inserting the left ventricular vascular access (1) in the subject of any one of Schemes 1 to 16 through a femoral artery of the patient under the guidance of a guide wire Until the pigtail section (11), extension section (12), and blood sampling port section (13) enter the left ventricle of the patient.
  • the method according to Scheme 19 and Scheme 17, which further comprises connecting the left ventricle vascular access (1) and the blood return pipeline (2) with an extracorporeal pump, so that the extracorporeal pump is connected to the left ventricle via the left
  • the ventricular blood vessel (1) draws blood from the left ventricle of the patient, and returns the drawn blood to the patient's arterial blood vessel through the blood return pipeline (2).
  • a left ventricular blood vessel taking tract (1) which in turn includes: a protective section, a blood taking port section (13), and a delivery section (14);
  • the protective section has a tube end formed of a flexible shape and/or a flexible material for avoiding damage to the left ventricle during operation;
  • the tube wall of the blood sampling port section (13) has a plurality of holes, that is, the blood sampling hole (131);
  • the length of the conveying section (14) is 700mm to 1400mm, the inner diameter of the tube is 3mm to 6.5mm, for example, 3.5mm to 6.4mm, and the inner diameter of the tube is 4mm to 6.2mm, 4.5mm to 6.5mm,
  • an angle of about 120 to about 170 degrees is formed between the blood sampling port section (13) and the delivery section (14).
  • the protection section includes a pigtail section (11) and an extension section (12);
  • the pigtail section (11), as the end of the blood vessel, has an outer diameter of 1 mm to 3 mm, and a circle with a diameter of 7 mm to 13 mm is formed at one end of the left ventricular blood vessel removal channel (1);
  • the length of the blood sampling port (13) is 30mm to 70mm, and the inner diameter of the tube is 3mm to 6.5mm, for example, 4.5mm to 6.5mm,
  • the extension section (12) connects the pigtail section (11) and the blood sampling port section (13).
  • the length of the pigtail section is more than 20mm, for example 20mm to 38mm,
  • the length of the extension section (12) is 7 mm to 13 mm.
  • the left ventricular blood vessel taking tract (1) according to claim 20, wherein the left ventricular blood vessel taking tract (1) further comprises: a blood taking pump connector (15), and the blood taking pump connector ( 15) Connected to the delivery section (14), used to connect the left ventricular blood vessel (1) with the inlet of the extracorporeal pump (3), at the interface of the blood pump connector (15)
  • the inner diameter of the tube is more than 1.1 times, more than 1.2 times, or more than 1.3 times the inner diameter of the tube of the delivery section (14), for example, the inner diameter of the tube at the interface of the blood sampling pump connector (15) is more than 7 mm;
  • the left ventricular vascular access tract (1) is not provided with a pump component; and the delivery section (14) of the left ventricular vascular access (1) is not provided with a side opening.
  • Option 25 The left ventricular blood sampling tract (1) according to Option 20, wherein the area of each of the plurality of blood sampling holes (131) is greater than or equal to 1 mm 2 , and the area of the blood sampling holes (131) is less than or equal to 1 mm 2 And greater than or equal to 1 time of the cross-sectional area of the pipeline of the transport section (14), preferably greater than or equal to 1.1 times the cross-sectional area of the pipeline of the transport section (14), preferably greater than or equal to the cross-sectional area of the pipeline of the transport section (14) 1.2 times of, preferably greater than or equal to 1.5 times of the cross-sectional area of the pipeline of the conveying section (14).
  • Solution 27 The left ventricular blood vessel taking tract (1) according to claim 20, wherein the blood sampling hole is arranged in the front half of the blood sampling port.
  • Scheme 28 The left ventricular blood vessel taking tract (1) according to scheme 20, wherein the blood taking hole with more than 80 area% is set in the first half of the blood taking port section.
  • Scheme 29 The left ventricular blood vessel taking tract (1) according to any one of schemes 20 to 28, wherein the opening rate of the blood taking port section (13) in the longitudinal and circumferential directions is less than or equal to 75%, less than It is equal to 50%, for example, less than or equal to 40%, for example, less than or equal to 30%.
  • FIG. 1 is a schematic diagram of the left ventricle vascular access (1) in this embodiment.
  • the left ventricular vascular access (1) consists of a pigtail section (11), an extension section (12), and a blood sampling port (13) in sequence , The delivery section (14) and the pump connector (15) for blood collection;
  • the length of the pigtail section (11) is 20mm, a circle with a diameter of about 7mm is formed at one end of the pipe, and the pipe outer diameter of the pigtail section (11) is 2mm and the inner diameter is 1mm;
  • the length of the blood sampling port section (13) is 50mm, the inner diameter of the tube is 6mm, the tube wall of the blood sampling port section (13) has 17 blood sampling holes (131), and the blood sampling holes (131) are arranged in In the first half of the blood sampling port section (13), the area of each of the blood sampling holes (131) is 2.0 mm 2 , and the sum of the areas of the blood sampling holes (131) is the pipeline of the transport section (14) 1.2 times the cross-sectional area,
  • the length of the delivery section (14) is 900mm, the inner diameter of the tube is 6mm, and an angle of about 150 degrees is formed between the blood sampling port section (13) and the delivery section (14);
  • the length of the extension section (12) is 10mm, the inner diameter of the tube changes from 1mm of the pigtail section (11) to the inner diameter of the blood sampling port (13) 6mm, and the outer diameter of the tube is from the The outer diameter of the pigtail section (11) is changed from 2mm to the outer diameter of the blood sampling port (13) is 6.5mm;
  • the tube inner diameter of the blood sampling pump connector (15) is 7.2 mm, which is 1.2 times the tube inner diameter of the delivery section (14).
  • the pigtail section (11), the extension section (12), the blood sampling port section (13), and the delivery section (14) are all made of nylon 12 and embedded with stainless steel wire mesh.
  • FIG. 2 is a schematic diagram of the blood return pipeline (2) in this embodiment.
  • the blood return pipeline (2) in turn includes: a terminal section (21), a blood return port section (22), a return section (23) and a pump for return Connector (24).
  • the length of the return section (23) is 100mm, and the inner diameter of the pipe is 6mm,
  • the inner diameter of the blood return hole section (22) is 6mm, and the length of the blood return hole section (22) is 50mm; the wall of the blood return hole section (22) has 17 blood return holes (221).
  • the area of each of the blood return holes (221) is 2.0 mm 2 , and the sum of the areas of the blood return holes (221) is 1.2 times the cross-sectional area of the pipeline of the return section (23),
  • the length of the end section (21) is 10mm
  • the inner diameter of the tube changes from the inner diameter of the blood return port section (22) from 6mm to the end of about 2mm
  • the outer diameter of the tube is about 6.5 from the tube outer diameter of the blood return port section (22).
  • the mm changes to about 2.5 mm at the very end.
  • the pipe inner diameter of the return pump connector (24) is 7.2 mm, which is 1.2 times the pipe inner diameter of the return section (23).
  • FIG 3 is a schematic diagram of the artificial arterial blood extracorporeal circulation system in this embodiment, which includes the left ventricular blood vessel taking tract (1) shown in Figure 1, the blood return pipeline (2) shown in Figure 2 and the extracorporeal pump (3) ,
  • the extracorporeal pump (3) is a centrifugal pump that outputs a pressure of 140 mmHg, and the inner diameter of the input and output pipes is equal to 7.2 mm. Accordingly, the blood sampling pump connector (15) and the return pump The pipe diameter of the joint (24) is matched with the input and output pipes of the extracorporeal pump (3).
  • Figure 5 is a schematic diagram of the artificial arterial blood extracorporeal circulation system of this embodiment during treatment.
  • the artificial arterial blood extracorporeal circulation system in this embodiment returns arterial blood to the aortic blood vessel closer to the inner thigh during the treatment process.
  • FIG. 4 shows the artificial arterial blood extracorporeal circulation system in this embodiment, which includes a left ventricular blood vessel (1), a blood return pipeline (2), and an extracorporeal pump (3). Its structural parameters are roughly the same as those of Embodiment 1. The same, the difference is that the length of the return section (23) of the blood return pipeline (2) is 900mm, and the left ventricular blood collection channel (1) and the blood return pipeline (2) are provided with a thin layer inside.
  • the stainless steel wire mesh is used to enhance the strength of the pipeline.
  • the extracorporeal pump (3) outputs a pressure of 150 mm Hg, and the inner diameter of the input and output pipelines is equal to 10 mm.
  • the blood sampling pump connector (15) and the The pipe diameter of the return pump connector (24) matches the input and output pipes of the extracorporeal pump (3).
  • the artificial arterial blood extracorporeal circulation system in this embodiment injects arterial blood back to the aorta near the left ventricle during treatment.
  • Arterial blood flows in the blood vessels in a normal way similar to the pumping power provided by the heart. Achieve better blood circulation effect.
  • Example 2 for the composition of the artificial arterial blood extracorporeal circulation system used in this experiment.
  • the left ventricular vascular access and blood return pipeline are prepared by continuous extrusion process. Both pipelines use a composite structure reinforced by nylon outer skin and stainless steel wire mesh inner layer. The tube wall thickness is about 0.3mm.
  • the extracorporeal pump adopts Marquet's extracorporeal circulation pump. (Rolling pump).
  • the specific parameters of the pipeline prepared in this embodiment are as follows:
  • the experiment is mainly to test the blood supply capacity of the system, the basin is used to collect the amount of water drawn through the artificial arterial blood extracorporeal circulation system to measure the flow rate, and the pressure monitoring system is used to monitor the pressure in the tube.
  • the pipeline of this embodiment can provide a flow rate of up to 4.5 L/min at a lower pipeline pressure.
  • This example provides an animal experiment of the artificial arterial blood extracorporeal circulation system described in this application.
  • the common iliac artery was found under ultrasound in experimental pigs, the common iliac artery was freed, and the sheath was placed on both sides and surgically ligated to stop bleeding. Suture hemostasis and suture the skin, leaving the outer port of the sheath outside the body.
  • composition of the artificial arterial blood extracorporeal circulation system used in this experiment can refer to Example 3.
  • the left ventricular vascular access and blood return pipeline are the pipelines prepared in Example 3, and the extracorporeal circulation pump of Marquet is used as the extracorporeal circulation pump. (Rolling pump).
  • the left ventricle vascular tract into the left ventricle is connected to the hemostatic valve, with a contrast guide wire, and enters the left ventricle under DSA. If necessary, the tip of the contrast guide wire can be pre-shaped. Heparin was supplemented with 25mg, and heparin was pumped in 800u/h iv to maintain blood ACT for 200-250s.
  • the blood return pipeline is equipped with a hemostatic valve and a contrast guide wire, and enters the aortic arch.
  • Basic parameter tolerance test set the pump flow to 2.5L/min, run the system continuously, and measure the pipeline pressure, actual blood flow, free hemoglobin, arterial blood pressure ABP, blood ACT at 1.5h, 8h, 24h, 36h, and 48h respectively , Observe the hemolysis (Generally speaking, when the free hemoglobin is higher than 0.3g/dL, it indicates that more severe hemolysis has occurred, and when the free hemoglobin is less than 0.04g/dL, it indicates that no significant hemolysis has occurred.).
  • the extracorporeal circulation system can provide about 2.7-3L/min for experimental pigs for 48 hours, with little data fluctuation, the extracorporeal system has good stability and can meet normal physiological needs; 2. Rolling The pump continues to run for 48 hours, the free hemoglobin is low, there is no obvious hemolysis and blood cell destruction, indicating that the extracorporeal circulation system has high safety; 3. When the return blood volume increases, and the normal cardiac output decreases, the pipeline flow rate is It may be further increased. When the in vitro test reaches 4.5 liters, the pressure is only 120 mm Hg. In theory, at 210 mm Hg, the blood volume should reach about 5 liters, which can meet the higher blood supply demand.
  • This application also contains the following content:
  • Embodiment 1 An arterial blood circulation pipeline assembly, comprising: a left ventricular vascular access, the left ventricular vascular access is composed of a pigtail section, an extension section, a blood sampling port section, and a delivery section in sequence;
  • the length of the pigtail section is 20mm or more, such as 20mm to 38mm, a circle with a diameter of 8mm to 12mm is formed at one end of the pipe, and the pipe outer diameter of the pigtail section is 1-3mm;
  • the length of the blood sampling port section is 30 mm to 70 mm, the inner diameter of the tube is 4.7 mm to 6.3 mm, and the tube wall of the blood sampling port section has a plurality of holes, which are called blood sampling holes;
  • the length of the conveying section is 700 mm to 1400 mm, the inner diameter of the tube is 4.7 mm to 6.3 mm, and an angle of about 130 to about 160 degrees is formed between the blood sampling port section and the conveying section;
  • the length of the extension section is 8 mm to 12 mm.
  • Embodiment 2 The arterial blood circulation pipeline assembly according to embodiment 1, wherein the inner diameter of the tube of the delivery section is 5.4 mm to 6.0 mm, and the length is 800 mm to 1100 mm. An angle of about 140 to about 160 degrees is formed between.
  • Embodiment 3 The arterial blood circulation pipeline assembly according to embodiment 1, further comprising a blood return pipeline, and the blood return pipeline includes a terminal section, a blood return port section, and a return section in sequence,
  • the length of the return section is 100mm to 1000mm, and the inner diameter of the tube is 4.5mm to 6.5mm,
  • the inner diameter of the tube of the blood return hole section is 4.5 mm to 6.5 mm, and the tube wall of the blood return hole section has a plurality of holes, which are called the blood return hole.
  • the length of the blood return hole section is 30 mm to 70 mm;
  • the length of the end section is greater than or equal to 10 mm, the inner diameter of the tube changes from the inner diameter of the blood return port section to the end 1-3 mm, and the outer diameter of the tube changes from the outer diameter of the blood return port section to about 1 at the end. -3mm.
  • Embodiment 4 The arterial blood circulation tube assembly according to embodiment 3, wherein the length of the return section is 700 mm to 900 mm or 100 mm to 200 mm, and the inner diameter of the tube is 5.4 mm to 6.0 mm.
  • the infusion section is longer, and the infusion section can be set on the aorta, so that the blood taken from the left ventricle can normally enter the aorta to circulate. When it is not transferred back to the aorta, it is only necessary to transport the taken blood into the arterial blood vessel. Therefore, 100mm to 200mm can meet the requirements and can reduce the delivery pressure.
  • Embodiment 5 The arterial blood circulation pipeline assembly according to embodiment 3, wherein the blood return pipeline further comprises: a pump connector for return, the pump connector for return is used to connect to the outlet of an external pump, and the return
  • the inner diameter of the pipe at the interface of the pump joint is more than 1.1 times, 1.2 times, or 1.3 times the pipe inner diameter of the return section.
  • the pipe inner diameter at the interface of the pump joint for return is 7 mm or more.
  • Embodiment 6 The arterial blood circulation pipeline assembly according to embodiment 1, wherein the left ventricular blood collection tract further comprises: a pump connector for blood collection, and the pump connector for blood collection is connected to the delivery section.
  • the inner diameter of the tube at the interface of the blood taking pump connector is 1.1 times, 1.2 times or more, or 1.3 times the inner diameter of the tube of the delivery section,
  • the inner diameter of the tube at the interface of the blood sampling pump connector is 7 mm or more;
  • the left ventricular vascular access tract is not provided with a pump component; and the delivery section of the left ventricular vascular access tract is not provided with a side opening.
  • Embodiment 7 The arterial blood circulation pipeline assembly according to embodiment 1, wherein the area of each of the plurality of blood sampling holes is greater than or equal to 1 mm 2 , and the sum of the areas of the blood sampling holes is greater than or equal to the cross-sectional area of the pipeline of the transport section 1 time, preferably greater than or equal to 1.1 times the cross-sectional area of the pipeline in the conveying section, preferably greater than or equal to 1.2 times the cross-sectional area of the pipeline in the conveying section, preferably greater than or equal to 1.5 times the cross-sectional area of the pipeline in the conveying section.
  • Embodiment 8 An artificial arterial blood extracorporeal circulation system, comprising: a left ventricular blood vessel taking tract, an extracorporeal pump and a blood return pipeline,
  • the inner diameter of the input and output pipes of the extracorporeal pump is greater than the inner diameter of the left ventricular vascular access, for example, the inner diameter of the input and output pipes of the extracorporeal pump is more than 1.1 times the inner diameter of the delivery section of the left ventricular vascular access , 1.2 times or more, or 1.3 times or more.
  • the external support provides doctors with longer medical time.
  • Embodiment 9 The artificial arterial blood extracorporeal circulation system according to embodiment 8, wherein the inner diameter of the input and output pipes of the extracorporeal pump is greater than or equal to 7.00 mm.
  • Embodiment 10 The artificial arterial blood extracorporeal circulation system according to embodiment 8, wherein the extracorporeal pump is a centrifugal pump, a squeeze pump, or a roller pump, and can output 100 to 200 mmHg or 100 to 300 mmHg pressure.
  • the extracorporeal pump is a centrifugal pump, a squeeze pump, or a roller pump, and can output 100 to 200 mmHg or 100 to 300 mmHg pressure.
  • Embodiment 11 The artificial arterial blood extracorporeal circulation system according to embodiment 8, wherein:
  • the left ventricular blood vessel sampling tract includes a pigtail section, an extension section, a blood sampling port section, and a delivery section in sequence;
  • the length of the pigtail section is 20 to 38mm, a circle with a diameter of 8mm to 12mm is formed at one end of the pipe, and the outer diameter of the pipe of the pigtail section is 1-3mm;
  • the length of the blood sampling port section is 30 mm to 70 mm, the inner diameter of the tube is 4.7 mm to 6.3 mm, and the tube wall of the blood sampling port section has a plurality of blood sampling holes;
  • the length of the delivery section is 800mm to 1200mm, the inner diameter of the tube is 4.7mm to 6.3mm, and an angle of about 130 to about 160 degrees is formed between the blood sampling port section and the delivery section;
  • the length of the extension section is 8 mm to 12 mm, and the inner diameter of the tube varies from the inner diameter of the pigtail section to the inner diameter of the blood sampling section;
  • the blood return pipeline sequentially includes: a terminal section, a blood return port section and a return section,
  • the length of the return section is 100mm to 1000mm, and the inner diameter of the tube is 4.5mm to 6.5mm,
  • the length of the blood return hole section is 30 mm to 70 mm, the inner diameter of the tube is 4.5 mm to 6.5 mm, and the tube wall of the blood return hole section has multiple blood return holes;
  • the length of the end section is greater than or equal to 10 mm, the inner diameter of the tube changes from the inner diameter of the blood return port section to the end 1-3 mm, and the outer diameter of the tube changes from the outer diameter of the blood return port section to about 1 at the end. -3mm.

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

Abstract

L'invention concerne un ensemble conduit de circulation sanguine artérielle et système de circulation sanguine artérielle artificielle extracorporelle. L'ensemble comprend un conduit de prélèvement de sang ventriculaire gauche (1) formé par une section en queue de cochon (11), une section d'extension (12), une section d'orifice de prélèvement de sang (13) et une section de transport (14) en séquence. La longueur de la section en queue de cochon (11) est de 20 à 38 mm, la longueur de la section d'extension (12) est de 7 à 13 mm, la longueur de la section de l'orifice de prélèvement de sang (13) est de 30 à 70 mm, et la longueur de la section de transport (14) est de 700 à 1400 mm. L'ensemble conduit de circulation sanguine artérielle et le système de circulation sanguine artérielle extracorporelle peuvent assister une fonction de pompage sanguin du cœur et fournir un support de circulation sanguine artérielle extracorporelle pendant 48 heures ou même plus longtemps pour les patients.
PCT/CN2020/132213 2019-11-28 2020-11-27 Ensemble conduit de circulation sanguine artérielle et système de circulation sanguine artérielle artificielle extracorporelle WO2021104449A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201911192276.3A CN112843463A (zh) 2019-11-28 2019-11-28 一种动脉血液循环管道组件和人工动脉血液体外循环系统
CN201922091693.0U CN212187286U (zh) 2019-11-28 2019-11-28 一种动脉血液循环管道组件和人工动脉血液体外循环系统
CN201911192276.3 2019-11-28
CN201922091693.0 2019-11-28

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070282243A1 (en) * 2006-06-01 2007-12-06 N.G.C Medical S.P.A Apparatus for performing myocardial revascularization in a beating heart and left ventricular assistance condition
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
CN105102011A (zh) * 2012-08-15 2015-11-25 前进医药公司 血泵系统以及方法
CN207708250U (zh) * 2017-04-13 2018-08-10 北京大学深圳医院 用于心衰的辅助血液循环装置
CN109999315A (zh) * 2019-03-21 2019-07-12 李庆国 经皮左心引流管
CN110237327A (zh) * 2019-06-14 2019-09-17 湖南埃普特医疗器械有限公司 一种驱动外置型轴流心室辅助装置

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070282243A1 (en) * 2006-06-01 2007-12-06 N.G.C Medical S.P.A Apparatus for performing myocardial revascularization in a beating heart and left ventricular assistance condition
CN105102011A (zh) * 2012-08-15 2015-11-25 前进医药公司 血泵系统以及方法
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
CN207708250U (zh) * 2017-04-13 2018-08-10 北京大学深圳医院 用于心衰的辅助血液循环装置
CN109999315A (zh) * 2019-03-21 2019-07-12 李庆国 经皮左心引流管
CN110237327A (zh) * 2019-06-14 2019-09-17 湖南埃普特医疗器械有限公司 一种驱动外置型轴流心室辅助装置

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