WO2023155656A1 - Microcathéter non traversant pour administration locale et instrument médical le comprenant - Google Patents

Microcathéter non traversant pour administration locale et instrument médical le comprenant Download PDF

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Publication number
WO2023155656A1
WO2023155656A1 PCT/CN2023/073051 CN2023073051W WO2023155656A1 WO 2023155656 A1 WO2023155656 A1 WO 2023155656A1 CN 2023073051 W CN2023073051 W CN 2023073051W WO 2023155656 A1 WO2023155656 A1 WO 2023155656A1
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WO
WIPO (PCT)
Prior art keywords
section
microcatheter
opening
arc shape
inner diameter
Prior art date
Application number
PCT/CN2023/073051
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English (en)
Chinese (zh)
Inventor
丁海雁
Original Assignee
联易佳医疗技术服务(北京)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 CN202210138453.5A external-priority patent/CN116637269A/zh
Priority claimed from CN202210138434.2A external-priority patent/CN116637268A/zh
Priority claimed from CN202220302858.3U external-priority patent/CN218607684U/zh
Priority claimed from CN202220303563.8U external-priority patent/CN219231114U/zh
Priority claimed from CN202222399075.4U external-priority patent/CN219231191U/zh
Priority claimed from CN202211100733.3A external-priority patent/CN117679602A/zh
Priority claimed from CN202222399073.5U external-priority patent/CN219231116U/zh
Application filed by 联易佳医疗技术服务(北京)有限公司 filed Critical 联易佳医疗技术服务(北京)有限公司
Publication of WO2023155656A1 publication Critical patent/WO2023155656A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing

Definitions

  • the invention relates to the field of medical technology, in particular to a non-penetrating microcatheter for local administration and a medical device containing it.
  • the present invention provides a microcatheter for local administration, which includes the following embodiments:
  • Embodiment 1 A microcatheter for local drug delivery, which comprises in turn from the proximal end to the distal end: a delivery section, a fixed section, an aperture section and an end section, and the delivery section, the fixation section and the aperture section have A connected inner cavity with an outer diameter of 1.5F to 5F and an inner diameter of 0.40mm to 1.5mm; the length of the terminal section is 1 to 40mm, and a guide wire hole is provided; the fixed section has a preformed arc shape , used to relatively fix the position between the microcatheter and the blood vessel through the shape after the microcatheter is set; the end of the opening section is blocked, so that the opening section and the The end section is not connected, the opening section is provided with a first side opening, a marker is provided near the opening section, for example, a marker is provided at the junction of the opening section and the fixed section, It is used to help external equipment to detect its position in the patient; the outer surface of the arc-shaped top of the fixed section is provided with a second side opening
  • Embodiment 2 The microcatheter for local drug delivery according to Embodiment 1, wherein the length of the end segment is 6 mm to 20 mm.
  • Embodiment 3 The microcatheter for local drug delivery according to embodiment 1, wherein the outer diameter of the delivery section, the fixation section and the opening section is 1.7F to 4F, preferably 1.7 to 2.6F, and the inner diameter is 0.45 mm to 1.2mm.
  • Embodiment 4 The microcatheter for local administration according to embodiment 1, wherein the anticoagulant coating is heparin coating, phosphorylcholine coating or heparin-like coating, etc., wherein the microcatheter Anticoagulant coatings are provided on the inner and outer surfaces of the inner and outer surfaces.
  • Embodiment 5 The microcatheter for local drug delivery according to Embodiment 1, wherein the inner and outer surfaces of the microcatheter are provided with an anticoagulant coating.
  • Embodiment 6 The microcatheter for local drug delivery according to Embodiment 1, wherein the delivery section has a length of 0.4 to 1.5 m, 0.7 to 1.3 m, 0.8 to 1.3 m or 1.1 to 1.3 m.
  • Embodiment 7 The microcatheter for local drug delivery according to Embodiment 1, wherein the first side opening on the aperture section is arranged at the proximal end of the aperture section, and is arranged along the circumference of the catheter 2 to 20.
  • Embodiment 8 The microcatheter for local drug delivery according to Embodiment 1, wherein the arch height of the arc shape is 2 mm to 40 mm, and the arc shape span is 2 mm to 60 mm.
  • Embodiment 9 The microcatheter for local drug delivery according to Embodiment 1, wherein the number of second side openings disposed outside the top of the arc-shaped shape is 1 to 4.
  • Embodiment 10 The microcatheter for local drug delivery according to Embodiment 1, wherein the total area of the second side openings arranged outside the arc-shaped top of the fixing section does not exceed the area of the second side openings arranged on the opening One-fifth of the total area of the openings on the first side of the segment.
  • Embodiment 11 The microcatheter for local drug delivery according to Embodiment 1, wherein the microcatheter further includes a proximal syringe pump joint section, and the outer diameter of the syringe pump joint section is less than or equal to 6F.
  • Embodiment 12 The microcatheter for local drug delivery according to Embodiment 11, wherein the conveying section, the fixing section and the opening section comprise a PTEF inner layer, a metal braided middle layer, and a nylon outer layer.
  • a microcatheter for local drug delivery which comprises in sequence from the proximal end to the distal end: a delivery section, an aperture section, a fixed section and an end section, the delivery section, the aperture section and at least partially fixed
  • the segment has a communicating lumen with an outer diameter of 1.5F to 5F and an inner diameter of 0.40 mm to 1.5 mm;
  • the end segment is substantially straight and has a length of 1 to 40 mm;
  • the fixed segment has a preformed arc
  • the shape is used to relatively fix the position between the microcatheter and the blood vessel through the shape after the microcatheter is set, and the straight end section is free in the blood vessel;
  • the opening section is provided with a first side
  • a marker is provided near the hole section, for example, a marker is provided at the connection between the hole section and the fixed section and/or the connection between the hole section and the delivery section, It is used to help external equipment detect its position in the patient’s body;
  • a second side opening is provided on the outside of
  • the outer surface of the microcatheter is provided with an anticoagulant coating.
  • Embodiment 14 The microcatheter for local drug delivery according to embodiment 13, wherein the length of the end segment is 6 mm to 20 mm.
  • Embodiment 15 The microcatheter for local drug delivery according to embodiment 13, wherein the The outer diameter of the conveying section and the opening section is 1.7F to 4F, preferably 1.7 to 2.6F, and the inner diameter is 0.45mm to 1.2mm.
  • Embodiment 16 The microcatheter for local drug delivery according to embodiment 13, wherein the anticoagulant coating is heparin coating, phosphorylcholine coating or heparan-like coating.
  • Embodiment 17 The microcatheter for local drug delivery according to Embodiment 13, wherein the inner and outer surfaces of the microcatheter are provided with an anticoagulant coating.
  • Embodiment 18 The microcatheter for local drug delivery according to embodiment 13, wherein the delivery section has a length of 0.4 to 1.5 m, 0.7 to 1.3 m, 0.8 to 1.3 m or 1.1 to 1.3 m.
  • Embodiment 19 The microcatheter for local drug delivery according to embodiment 13, wherein the first side opening on the aperture segment is arranged at the proximal end of the aperture segment, and is arranged along the circumference of the catheter for 2 to 20.
  • Embodiment 20 The microcatheter for local drug delivery according to embodiment 13, wherein the arch height of the arc shape is 2 mm to 40 mm, and the span of the arc shape is 2 mm to 60 mm.
  • Embodiment 21 The microcatheter for local drug delivery according to Embodiment 13, wherein the number of second side openings disposed outside the top of the arc shape is 1 to 4.
  • Embodiment 22 The microcatheter for local drug delivery according to claim 13, wherein the total area of the second side openings arranged on the outer side of the arc-shaped top of the fixing section does not exceed the total area of the second side openings arranged on the opening One-fifth of the total area of the openings on the first side of the segment.
  • Embodiment 23 The microcatheter for local drug delivery according to Embodiment 13, wherein the microcatheter further includes a proximal syringe pump joint section, and the outer diameter of the syringe pump joint section is less than or equal to 6F.
  • Embodiment 24 The microcatheter for local drug delivery according to Embodiment 23, wherein the conveying section and the opening section comprise a PTEF inner layer, a metal braided middle layer, and a nylon outer layer.
  • Embodiment 25 A medical device for local drug delivery, which includes a guide tube, a guide wire, an auxiliary tube, a detachable luer connector, and the microcatheter according to any one of embodiments 1-24, wherein the The inner diameter of the auxiliary tube is smaller than the outer diameter of the most proximal end of the microcatheter, the outer diameter of the guide wire is smaller than the inner diameter of the guide wire through hole, the outer diameter of the auxiliary tube is greater than the inner diameter of the most proximal end of the micro catheter, and the guide wire The inner diameter of the tube is larger than the outer diameter of the microcatheter so that after the guide tube is used to help place the guidewire and microcatheter, it can be withdrawn with the help of the auxiliary tube, leaving the microcatheter in the human body.
  • Embodiment 26 The medical device for local drug delivery according to embodiment 25, wherein the outer diameter of the auxiliary tube is smaller than the inner diameter of the guide tube.
  • Embodiment 27 A medical device for local drug delivery, which includes a guide tube, a guide wire, an auxiliary wire, a detachable Luer connector, and the microcatheter described in any one of Embodiments 1-24, wherein the The outer diameter of the guide wire is smaller than the inner diameter of the guide wire through hole, the outer diameter of the auxiliary wire is larger than the inner diameter of the most proximal end of the microcatheter, and the inner diameter of the guide tube is larger than the outer diameter of the microcatheter, so that the After the guide tube is used to help place the guidewire and microcatheter, it can be withdrawn with the help of the auxiliary wire, leaving the microcatheter in the body.
  • Embodiment 28 The medical device for topical drug delivery according to embodiment 27, wherein The outer diameter of the auxiliary wire is smaller than the inner diameter of the guide tube.
  • Embodiment 29 The medical device for local drug delivery according to embodiment 27, wherein the distal end of the auxiliary wire has an extended connection section, and the outer diameter of the extended connection section is smaller than that of the most proximal end of the microcatheter. inner diameter, so that the extended connecting section can be inserted into the most proximal end of the microcatheter.
  • the size and shape characteristics of the microcatheter described in this application can realize highly selective intra-arterial administration for a long time, reduce the dosage to less than 20% of the conventional dosage, and avoid damage to other organs of the body caused by excessive administration. Impact.
  • the microcatheter described in this application is relatively fixed between the body and the blood vessel for a long time, and the displacement is small.
  • the micropore at the administration end continues to discharge liquid, reducing contact with the target blood vessel intima.
  • the extension section is slender and floats in the blood vessel.
  • the damage to the intima of the blood vessel is not large, and the application defines that a second side opening is provided on the outside of the top of the arc shape of the fixed section, so that the anticoagulant drug can flow out through the second side opening on the outside of the top of the arc shape , to prevent thrombus in this part, further optimize the anticoagulant performance of the microcatheter, and place it in the artery/vein for a long time without thrombus. It is suitable for selective local drug delivery in the body for coronary artery, head, liver diseases, etc. , suitable for local administration of chemotherapy for cancer patients, reducing the damage of chemotherapy drugs to other parts and organs of the body, suitable for local antibiotic administration, local anticoagulant/procoagulant administration, etc.
  • the microcatheter of the present application is particularly suitable for interventional treatment for patients with acute coronary syndrome combined with gastrointestinal bleeding, that is, the stent implantation operation is completed without anticoagulant drugs during the gastrointestinal bleeding, and then through the The microcatheter is used for local anticoagulant administration, and at the same time, surgery or drug treatment is performed for gastrointestinal bleeding. After the bleeding is completely stopped, antiplatelet drugs are taken orally, and the microcatheter is removed.
  • the microcatheter of the present application is especially suitable for patients who cannot perform lung cancer resection under anesthesia due to severe coronary heart disease.
  • Fig. 1 is the schematic diagram that is used for the microcatheter of local administration in embodiment 1;
  • Fig. 2 is the partial schematic view of the microcatheter used for local administration in embodiment 1;
  • Fig. 3 is the schematic diagram of the microcatheter used for coronary artery local administration in embodiment 2;
  • Fig. 4 is the local schematic diagram of the microcatheter used for coronary artery local administration in embodiment 2;
  • Fig. 5 to Fig. 12 are the schematic diagrams of setting local drug delivery medical device in the body in embodiment 2;
  • Fig. 13 is a schematic diagram of the microcatheter used for local drug delivery in cerebral blood vessels in Example 3.
  • the present invention provides a microcatheter for local drug delivery, which comprises in turn from the proximal end to the distal end: a delivery section, a fixed section, an aperture section and a terminal section, and the delivery section, the fixation section and the aperture section have A connected lumen with an outer diameter of 1.5F to 5F and an inner diameter of 0.40mm to 1.5mm; the length of the end segment is 1 to 40mm (such as 2mm to 35mm, 4mm to 30mm, 6mm to 25mm), and a guide wire is provided Through holes; the fixing section has a preformed arc shape, which is used to relatively fix the position between the microcatheter and the blood vessel through the shape after the microcatheter is set; the end of the opening section is Blocked so that the opening section does not communicate with the end section, the opening section is provided with a second side opening, and a marker is provided near the opening section, such as at the opening A marker is provided at the connection between the section and the fixed section, which is used to help the external equipment detect its position in the patient
  • each segment of the microcatheter in this application is not completely fixed, because the functions of these segments also overlap with each other.
  • the fixing section has the function of fixing the microcatheter and the blood vessel, it still has the function of the delivery section.
  • the boundary between the opening section and the fixing section may not be particularly sharp.
  • the start of the perforated section can be the perforated site, and the end of the perforated section can be the plugged site.
  • the starting position of the fixed section may be the starting position of the arc shape, and the ending position may be the ending position of the arc shape.
  • the division of the starting part and the ending part of the fixed segment can also be properly adjusted according to the division of the two segments connected to it. effect. Similarly, the division of other segments can also be divided according to the actual situation and the functions to be realized.
  • the microcatheter described in this application is flexible, and the shape described in this application is a similar shape displayed by the microcatheter in the natural state, and can be achieved according to the understanding of those skilled in the art shape.
  • the overall shape of the microcatheter is adapted to the vascular path implanted in the body, which makes it easier to implant the microcatheter into the target area and adapt to long-term placement in the blood vessel, such as a microcatheter for local drug delivery in the coronary artery.
  • the microcatheter, its conveying section, opening section, and end section are basically straight in the axial direction of the microcatheter. Those skilled in the art can reasonably set the overall shape of the microcatheter according to the implantation area.
  • the transition between the head-to-tail connection line at the arc of the fixed section and its front and rear sections can form a certain angle, such as 70-160°, such as 80-150°, such as 90° to 120°, or It is straight (that is, 180°), those skilled in the art can set it according to actual needs, and there is no special limitation.
  • the unit F in this application has the meaning commonly understood by those skilled in the art, and 1F refers to microguide Tubes have a circumference of 1 mm, 1.5F refers to a microcatheter with a circumference of 1.5 mm, and 4F refers to a microcatheter with a circumference of 4.0 mm.
  • the outer diameter is 1.5F to 5F refers to the outer diameter when the circumference is 1.5F to 5F.
  • the shape of the microcatheter described in the present application can be placed in the body for a long time and administered locally through blood vessels, and is suitable for areas such as the head, liver, and coronary arteries of the heart, and can be kept in the patient's body for a long time during surgery.
  • the outer diameter of the microcatheter described in this application is 1.5F to 5F, and this size allows the microcatheter to be placed in the body for a long time without causing hemolysis and other adverse reactions;
  • the section has a through lumen with an inner diameter of 0.40mm to 1.5mm, which enables the microcatheter to be administered through a high-pressure syringe pump tube;
  • the end section is provided with a guidewire through hole, which can accommodate the guidewire for microcatheter setting, and free in blood vessels.
  • the arch height of the preformed arc shape is 2mm to 40mm, and the span of the preform arc shape is 2mm to 60mm, which can be selected according to the required blood vessels.
  • the arch height of the preformed arc shape is 2mm to 35mm, or 4mm to 30mm, or 8mm to 25mm, or 2mm to 12mm
  • the span of the preformed arc shape is 2mm to 50mm, or 4mm to 50mm, or 8mm to 45mm, or 12mm to 40mm, or 20mm to 35mm, or 2mm to 12mm
  • the arc shape relatively fixes the microcatheter in the blood vessel, so that the microcatheter does not shift, and it does not damage the intima of the blood vessel when placed in the body for a long time, and does not affect the blood flow , for local administration.
  • the top of the arc shape when the arc shape relatively fixes the microcatheter in the blood vessel, the top of the arc shape usually abuts against the blood vessel wall, and thrombus is easily formed at this position.
  • This application defines "the top of the arc shape of the fixing section
  • the outer side is provided with a "second side opening", so that anticoagulant drugs can flow out through the second side opening on the outer side of the arc-shaped top, preventing thrombus in this part, and further optimizing the anticoagulant performance of the microcatheter. It makes it difficult for the microcatheter to be placed in the artery for a long time to grow thrombus.
  • the top of the arc shape refers to the middle region of the arc shape, that is, the area occupying 1/3 of the length of the middle part of the arc shape.
  • the outer side of the arc shape refers to the side of the arc shape against the blood vessel wall, and setting the second side opening outside the top of the arc shape is more conducive to preventing thrombus at this part.
  • the second side opening is arranged on the outer side within a range of 0.5mm to 10mm close to the apex of the arc shape.
  • the opening on the first side of the opening section communicates with the inner cavity, and the opening section is not connected to the end section, so that the medicine in the inner cavity can pass through the opening on the first side of the opening section and the end section.
  • the second side opening on the outer top side of the curved shape of the fixed section flows out to the target area.
  • Those skilled in the art can reasonably set the number of openings on the first side in combination with the scope of the administration target area, for example, 2 to 20, or 2 to 4, or 2 to 4 on the outer periphery of the opening section along the circumference of the catheter, or One hole segment is arranged every 30-120° along the circumferential direction of the conduit on the outer periphery.
  • a marker (marking material) is provided between the fixing section and the opening section, and the marker is used to help the external device detect its position in the patient's body.
  • the applicant of the present application unexpectedly found that the size setting of the microcatheter can reduce the dosage to less than 20% of the conventional dosage, avoiding the impact on other organs of the body caused by excessive dosage.
  • the microcatheter is placed in the vein without thrombus within 24 hours, and it is not easy to grow thrombus when placed in the artery for a long time. It is suitable for local administration of coronary artery, head, liver and other diseases through blood vessels, and is suitable for local administration of chemotherapy to cancer patients. Drugs to reduce the damage of chemotherapy drugs to other parts and organs of the body.
  • the microcatheter is required to perform surgery or hemostatic treatment on the patient during the transitional period created by the interventional therapy under local anticoagulation. It is especially suitable for patients with malignant tumors combined with coronary heart disease. After coronary intervention therapy, under the condition of local coronary anticoagulant administration, tumor resection can be performed safely and synchronously. It is also suitable for topical administration in other situations.
  • the length of the end segment is 6 mm to 20 mm.
  • the proper length of the tip section facilitates guiding the catheter over the guide wire to the target area.
  • the specific shape of the end segment is not limited,
  • the tip segment is straight, freeing the vessel in use.
  • a marker marking material
  • the shape of the microcatheter is suitable for local drug administration through blood vessels, such as the head, liver, coronary arteries of the heart, etc., and remains in the patient's body for a long time (such as more than 24 hours, or even 3-12 days) during the operation.
  • the outer diameter of the delivery section, the fixing section and the opening section is 1.7F to 4F, preferably 1.7 to 2.6F, and the inner diameter is 0.45mm to 1.2mm.
  • Such size design does not affect the blood in the body. Circulation, and not easy to form thrombus, can better realize the effect of local drug delivery.
  • the anticoagulant coating is a heparin coating, a phosphorylcholine coating or a heparan-like coating.
  • the inner and outer surfaces of the microcatheter are provided with an anticoagulant coating. Coagulation can be avoided to the greatest extent by coating the inner and outer surfaces of the microcatheter with an anticoagulant coating.
  • the delivery section has a length of 0.4 to 1.5 m.
  • the microcatheter is widely applicable to local administration of coronary arteries, local administration of liver cancer chemotherapy, and local administration of veins.
  • the conveying section has a length of 0.7 to 1.3 m, 0.8 to 1.3 m. Such a length setting makes the microcatheter especially suitable for local drug delivery in coronary arteries.
  • the delivery section has a length of 1.1 to 1.3 m. Such a length setting makes the microcatheter especially suitable for local drug delivery in coronary arteries.
  • the first side openings on the hole section are arranged at the proximal end of the hole section, and there are 2 to 20 holes arranged along the circumferential direction of the catheter.
  • the proximal end of the opening section is the starting position of the opening section, and the distance between the first side opening and the end of the microcatheter (ie the most distal end of the microcatheter) is less than 40 mm, for example, less than 20 mm.
  • the bow height of the arc shape is 2 mm to 40 mm, and the span of the arc shape is 2 mm to 60 mm.
  • the number of second side openings disposed on the outer side of the top of the arc shape is 1 to 4.
  • the total area of the second side openings disposed outside the arc-shaped top of the fixing section does not exceed one-fifth of the total area of the first side openings disposed on the opening section one.
  • the area of a single side opening is not particularly limited, and those skilled in the art can set it according to needs.
  • the second opening on the outer side of the top of the arc shape of the fixed section is mainly used to prevent thrombus from occurring in this part. It only needs to meet the amount of drug outflow to prevent thrombus. It is less than one-fifth of the total area of the openings on the first side on the opening section, so that the drug dose can be reduced to the greatest extent while maintaining good anticoagulant performance.
  • the microcatheter further includes a syringe pump joint section at the proximal end, and the outer diameter of the syringe pump joint section is less than or equal to 6F, such as 1.5F to 5F, such as less than or equal to 5.5F.
  • the joint section of the syringe pump can be connected with a high-pressure syringe pump tube, so that the medicinal liquid can be delivered to the local administration area through the inner cavity through which the microcatheter passes.
  • the connector section of the syringe pump is provided with a detachable or miniature Luer connector (Luer taper), which is connected to the syringe pump through the Luer connector.
  • the conveying section, the fixing section and the opening section comprise a PTEF inner layer, a metal braided middle layer, and a nylon outer layer.
  • the delivery section, fixation section, and aperture section comprise a wire inner layer and a polycarbonate skin layer.
  • the conveying section, the fixing section, the opening section and the end section independently adopt a three-layer structure, wherein the inner layer is made of polytetrafluoroethylene material (ie, PTEF inner layer), and the middle layer is 304
  • the stainless steel wire mesh layer is used as a support (ie, the metal weaving middle layer), and the outer layer is wrapped with nylon 12 (ie, the nylon outer layer).
  • the preparation method of the microcatheter or medical device described in the present application is not limited, and those skilled in the art can select appropriate methods, manufacturing equipment and materials according to actual needs.
  • the present invention also provides a microcatheter for local drug delivery, which sequentially comprises from the proximal end to the distal end: a delivery section, an opening section, a fixing section and a terminal section, the delivery section, the opening section and at least part of the
  • the fixed section has a connected lumen with an outer diameter of 1.5F to 5F and an inner diameter of 0.40mm to 1.5mm;
  • the end section is substantially straight and has a length of 1 to 40mm (for example, 2mm to 35mm, 4mm to 30mm, 6mm to 25mm);
  • the fixed section has a preformed arc shape (the arch height of the arc shape is 2mm to 40mm, and the span of the arc shape can be 2mm to 60mm, which can be selected according to the blood vessel required), It is used to relatively fix the position between the microcatheter and the blood vessel through the shape after the microcatheter is set, and the straight end section is free in the blood vessel;
  • the opening section is provided with a first side opening (the number of opening
  • the shape of the microcatheter described in this application can be placed in the body for a long time to administer local drugs through blood vessels, and is suitable for areas such as coronary artery, head, liver, kidney, lung, peripheral vascular diseases, etc. in vivo.
  • the outer diameter of the microcatheter described in the present application is 1.5F to 5F, and this size allows the microcatheter to be placed in the body for a long time without causing hemolysis and other adverse reactions;
  • the lumen has an inner diameter of 0.40 mm to 1.5 mm, which size enables the microcatheter to be administered through a high-pressure syringe pump tube.
  • the end segment and optionally The fixed section is provided with a guide wire through hole, which can accommodate the guide wire for setting the catheter and free in the blood vessel.
  • the arch height of the preformed arc shape is 2mm to 40mm, and the span of the preform arc shape is 2mm to 60mm, which can be selected according to the required blood vessels.
  • the arch height of the preformed arc shape is 2mm to 35mm, or 4mm to 30mm, or 8mm to 25mm, or 2mm to 12mm
  • the span of the preformed arc shape is 2mm to 50mm, or 4mm to 50mm, or 8mm to 45mm, or 12mm to 40mm, or 20mm to 35mm, or 2mm to 12mm
  • the arc shape relatively fixes the microcatheter in the blood vessel, so that the microcatheter does not shift and does not affect blood flow, which is convenient for local administration.
  • the fixed section When the fixed section is provided with a guidewire through hole located downstream of the blockage, when the microcatheter enters the blood vessel along the guidewire, the shape of the fixed section is consistent with that of the guidewire, which is convenient for implantation. After the guidewire is withdrawn, the fixed section recovers It is arc-shaped, so that the position between the microcatheter and the blood vessel is relatively fixed.
  • the first side opening on the opening section communicates with the inner cavity, so that the medicine in the inner cavity can reach the target area through the first side opening. Too many first side openings will easily lead to a decrease in the strength of the microcatheter.
  • the number of openings on the first side should not be too many, and those skilled in the art can reasonably set the number of openings on the first side in combination with the scope of the drug delivery target area, such as setting 2 to 20 along the circumference of the catheter, for example, on the outer periphery of the opening section One is set every 120°, that is, three first side openings are set on the outer circumference of the opening section.
  • the application defines that "the outer side of the arc-shaped top of the fixing section is provided with a second side opening, and the fixing section or the end section is blocked, so that the fixing section is not connected to the end section", seal
  • the blockage can be located at the fixed section or at the end section.
  • the second side opening of the fixed section communicates with the inner cavity and is located upstream of the blockage, so that the anticoagulant drugs can pass through the outer side of the top of the arc shape.
  • upstream refers to the proximal end relative to the operator
  • downstream refers to the distal end relative to the operator
  • markers are provided between the fixing section and the hole section and/or between the hole section and the delivery section, and the markers are used to help external equipment Detect its position in the patient's body.
  • the applicant of the present application unexpectedly found that the size setting of the microcatheter can reduce the dosage to less than 20% of the conventional dosage, avoiding the impact on other organs of the body caused by excessive dosage.
  • the microcatheter is placed in the vein without thrombus within 24 hours, and it is not easy to grow thrombus in the artery for a long time. It is suitable for local administration of coronary artery, head, liver, kidney, lung, peripheral vascular diseases, etc. through blood vessels.
  • the length of the end segment is 6 mm to 20 mm.
  • the proper length of the tip section facilitates guiding the catheter over the guide wire to the target area.
  • the outer diameter of the delivery section and the opening section is 1.7F to 4F, preferably 1.7F To 2.6F, the inner diameter is 0.45mm to 1.2mm.
  • the anticoagulant coating is a heparin coating, phosphorylcholine or heparan-like coating, optionally the anticoagulant coating is hydrophilic.
  • the inner and outer surfaces of the microcatheter are provided with an anticoagulant coating. Coagulation can be avoided to the greatest extent by coating the inner and outer surfaces of the microcatheter with an anticoagulant coating and soaking the microcatheter in an anticoagulant.
  • the delivery section has a length of 0.4 to 1.5 m.
  • the microcatheter is widely applicable to local administration of coronary arteries, local administration of liver cancer chemotherapy, and local administration of veins.
  • the conveying section has a length of 0.7 to 1.3 m, 0.8 to 1.3 m. Such a length setting makes the microcatheter especially suitable for local drug delivery in coronary arteries.
  • the delivery section has a length of 1.1 to 1.3 m. Such a length setting makes the microcatheter especially suitable for local drug delivery in coronary arteries.
  • the first side openings on the hole section are arranged at the proximal end of the hole section, and there are 2 to 20 holes arranged along the circumferential direction of the catheter.
  • the proximal end of the opening section is the starting part of the opening section, and the distance between the first side opening and the end of the microcatheter (ie the most distal end of the microcatheter) is less than 60mm, such as less than 40mm, such as less than 20mm.
  • the bow height of the arc shape is 2 mm to 40 mm, and the span of the arc shape is 2 mm to 60 mm.
  • the number of second side openings disposed on the outer side of the top of the arc shape is 1 to 4.
  • the total area of the second side openings disposed outside the arc-shaped top of the fixing section does not exceed one-third of the total area of the first side openings disposed on the opening section One, preferably one fifth.
  • the area of a single side opening is not particularly limited, and those skilled in the art can set it according to needs.
  • the second opening on the outer side of the top of the arc shape of the fixing section is mainly used to prevent thrombus from occurring at this part. It only needs to meet the drug outflow to prevent thrombus generation.
  • the total area of the openings on the first side of the segment is less than one-third, preferably less than one-fifth, so that the dosage can be reduced to the greatest extent while maintaining good anticoagulant performance.
  • the microcatheter further includes a syringe pump joint section at the proximal end, and the outer diameter of the syringe pump joint section is less than or equal to 6F, such as 1.5F to 5F, such as less than or equal to 5.5F.
  • the joint section of the syringe pump can be connected with a high-pressure syringe pump tube, so that the medicinal liquid can be delivered to the local administration area through the inner cavity through which the microcatheter passes.
  • the connector section of the syringe pump is provided with a Luer connector (Luer taper), which is connected to the syringe pump through the Luer connector.
  • the delivery section and the aperture section comprise an inner layer of PTFE, a middle layer of metal braid, and an outer layer of nylon. In some embodiments, the delivery section and aperture section comprise a wire inner layer and a polycarbonate skin layer.
  • the conveying section, the fixing section, the opening section and the terminal section each independently adopt a three-layer structure, wherein the inner layer is made of polytetrafluoroethylene material, and the middle layer is a 304 stainless steel wire mesh layer as a support , the outer layer is wrapped with nylon 12.
  • the preparation method of the microcatheter or medical device described in the present application is not limited, and those skilled in the art can select appropriate methods, manufacturing equipment and materials according to actual needs.
  • the application also discloses a medical device for local drug delivery, which includes a guide tube, a guide wire, an auxiliary tube, a detachable Luer connector and the microcatheter, wherein the inner diameter of the auxiliary tube is smaller than that of the microcatheter.
  • the outer diameter of the most proximal end of the catheter, the outer diameter of the guide wire is smaller than the inner diameter of the guide wire through hole, the outer diameter of the auxiliary tube is greater than or equal to the inner diameter of the most proximal end of the micro catheter, and the guiding catheter (guiding catheter, and The inner diameter of the guide catheter or guide catheter) is larger than the outer diameter of the microcatheter, so that the guide catheter can be withdrawn with the help of the auxiliary tube after it is used to help set the guide wire and microcatheter , leaving the microcatheter in the human body.
  • the guide tube When withdrawing the guide tube, use the auxiliary tube against the proximal end of the microcatheter outside the body, so that the guide tube can be withdrawn without affecting the position of the microcatheter in the body.
  • the microcatheter After the guide tube is withdrawn, The microcatheter is connected to a syringe pump via a Luer connector for local drug delivery.
  • the guide wire can be withdrawn with the help of the auxiliary tube without affecting the position of the microcatheter in the body.
  • the outer diameter of the auxiliary tube is smaller than the inner diameter of the guide tube. At this time, the auxiliary tube can be entered into the guide tube, and the guide tube can be withdrawn along the auxiliary tube.
  • the application also discloses a medical device for local administration, which includes a guide tube, a guide wire, an auxiliary wire, a detachable Luer connector and the microcatheter, wherein the outer diameter of the guide wire is smaller than the The inner diameter of the guidewire through hole, the outer diameter of the auxiliary wire is greater than the inner diameter of the most proximal end of the microcatheter, the inner diameter of the guide tube is greater than the outer diameter of the microcatheter, so that the guide tube is used to help set the After the guidewire and microcatheter are removed, the microcatheter can be withdrawn with the help of the auxiliary wire, leaving the microcatheter in the human body.
  • the guide tube When withdrawing the guide tube, use the auxiliary wire against the most proximal end of the microcatheter outside the body, so that the guide tube can be withdrawn without affecting the position of the microcatheter in the body.
  • the microcatheter After the guide tube is withdrawn, The microcatheter is connected to a syringe pump via a Luer connector for local drug delivery.
  • the guide wire can be withdrawn with the help of the auxiliary wire without affecting the position of the microcatheter in the body.
  • the outer diameter of the auxiliary wire is smaller than the inner diameter of the guide tube. At this time, the auxiliary wire can enter the guide tube, and the guide tube can be withdrawn along the auxiliary wire.
  • the distal end of the auxiliary wire has an extended connection section, and the outer diameter of the extended connection section is smaller than the inner diameter of the proximal end of the microcatheter, so that the extended connection section can be inserted into the microcatheter. the proximal end of the catheter.
  • the preparation method of the microcatheter described in the present application has no special requirements, and can be prepared by methods known to those skilled in the art. There is no special requirement for the strength of the microcatheter, and the strength of the microcatheter commonly used in this field can be used, and can be prepared according to the actual situation. Make adjustments.
  • the microcatheter described in this application is relatively fixed between the body and the blood vessel for a long time, the displacement is small, and the damage to the intima of the blood vessel is not large. It will not grow thrombus within 24 hours when it is placed in the vein, and it is not easy to grow thrombus when it is placed in the artery for a long time.
  • suitable for placing in the body through blood vessels to treat patients with head, liver, coronary artery disease It is suitable for local administration of chemotherapy in cancer patients. Using it for local administration can reduce the dosage to less than 20% of the conventional dosage, avoiding the adverse effects of excessive administration on other organs of the body. Surgery affecting other organs.
  • This embodiment discloses a microcatheter for local drug delivery, as shown in Fig. 1 and Fig. 2, it comprises in sequence from the proximal end to the distal end: a delivery section 100, a fixing section 200, an opening section 300 and a terminal section 400.
  • the length of the conveying section 100 is 1.1 m, and the conveying section 100, the fixed section 200 and the perforated section 300 have a connected lumen 110 with an outer diameter of 4F and an inner diameter of 1.0 mm; this size enables the microcatheter to be used for a long time Placed in the body without causing hemolytic reactions and other adverse reactions, and can be administered through a high-pressure injection pump tube.
  • the length of the end section 400 is 10mm, and it is provided with a guide wire through hole 610, which can accommodate the guide wire for setting the microcatheter and free in the blood vessel.
  • the fixed section 200 has a preformed arc shape, and the arc The arch height of the arc shape is 4mm, and the span of the arc shape is 20mm, which is used to relatively fix the position between the microcatheter and the blood vessel through the shape after the microcatheter is set, so that the microcatheter does not shift, and It does not affect the blood flow and is convenient for local administration; the end of the opening section 300 is blocked, so that the opening section 300 is not connected to the end section 400, and 3 holes are arranged on the outer periphery of the opening section A first side opening 310, so that the medicine in the inner cavity 110 can reach the target area through the first side opening 310; a marker 320 is provided at the junction of the opening section 300 and the fixing section 200, for use To help the external device detect its position in the patient's body;
  • the microcatheter is placed in the vein without thrombus within 24 hours, and it is not easy to grow thrombus when placed in the artery for a long time. It is suitable for local administration through blood vessels to patients with head, liver, and coronary artery disease, and is suitable for local administration of chemotherapy for cancer patients. , can reduce the dosage to less than 20% of the conventional dosage, and reduce the damage of chemotherapy drugs to other parts and organs of the body.
  • the microcatheter 10 sequentially comprises from the proximal end to the distal end: a syringe pump joint section 500 , a delivery section 100 , an opening section 300 , a fixing section 200 and a terminal section 400 .
  • the delivery section 100 has a length of 1.3m, the syringe pump joint section 500, the delivery section 100, the opening section 300 and the fixing section 200 have a connected inner cavity 110, and the outer diameter of the syringe pump joint section is 3.5F , the conveying section 100 and the opening section 300
  • the outer diameter of the inner cavity 110 is 2.6F, and the inner diameter of the lumen 110 is 0.6mm;
  • the end section 400 is basically straight and has a length of 10mm, which can be free in the blood vessel and is convenient for microcatheter implantation.
  • the catheter can be placed in the body for a long time without causing hemolytic reactions and other adverse reactions, and can be administered through a high-pressure syringe pump tube, wherein the syringe pump joint section 500 is made of polycarbonate material, the delivery section 100 and the opening Section 300 comprises an inner layer of wire and a skin of polycarbonate.
  • the fixing section 200 has a preformed arc shape with a bow height of 15 mm and a span of 40 mm.
  • the arc shape relatively fixes the microcatheter in the blood vessel.
  • the arc shape The top is against the wall of the blood vessel, so that the microcatheter does not displace and does not affect the blood flow, which is convenient for local drug delivery.
  • the overall shape of the microcatheter is shown in FIG. 3 .
  • An angle of about 90 degrees is formed between the delivery section 100 and the end section 400 of the microcatheter, which can be delivered and placed in the coronary artery more smoothly.
  • first side openings 310 are provided every 120° on the initial section of the opening section 300 , so that the medicine in the lumen 110 can reach the target area through the first side openings 310 .
  • a marker 320 is provided at the junction of the opening section 300 and the fixing section 200 and the junction of the opening section 300 and the delivery section 100 to help the external device detect its position in the patient's body .
  • a second side opening 210 is provided on the outside of the arc-shaped top of the fixing section 200 , and the end of the fixing section 200 is blocked, so that the fixing section 200 is not connected to the end section 400 , and make the second side opening 210 arranged outside the top of the arc shape communicate with the inner cavity 110, so that the anticoagulant drug can flow out through the second side opening 210 arranged outside the top of the arc shape, preventing this Thrombosis occurs at the site, further optimizing the anticoagulant performance of the microcatheter, making the microcatheter placed in the artery for a long time less prone to thrombus.
  • the end section 400 is provided with a guidewire through hole 610, which is located downstream of the end block of the fixed section 200, and can accommodate the guidewire for catheter setting.
  • the microcatheter enters the blood vessel along the guidewire, and the fixation
  • the curved shape of the section 200 keeps the position between the microcatheter and the blood vessel relatively fixed.
  • the inner and outer surfaces of the microcatheter are provided with an anticoagulant coating.
  • the microcatheter is placed in the vein without thrombus within 24 hours, and it is not easy to grow thrombus in the artery for a long time. It is suitable for local administration in patients with coronary artery disease, and the dosage can be reduced to less than 20% of the conventional dosage. Reduce drug damage to other parts and organs of the body.
  • 5 to 12 show schematic diagrams of setting the microcatheter in the body using a medical device for local drug delivery, wherein the outer diameter of the guide wire 600 is smaller than the inner diameter of the guide wire through hole 610, and the auxiliary wire 800
  • the outer diameter of the auxiliary wire 800 is greater than the inner diameter of the proximal end of the microcatheter 10
  • the outer diameter of the auxiliary wire 800 is smaller than the inner diameter of the guide tube 700
  • the inner diameter of the guide tube 700 is greater than the outer diameter of the microcatheter 10.
  • the distal end of the auxiliary wire 800 has an extended connection section 810, and the outer diameter of the extended connection section 810 is smaller than the inner diameter of the proximal end of the microcatheter, so that the extended connection section 810 can be inserted into the microcatheter. nearest end.
  • guide wire 600 is first set in target area, and guide tube 700 is pushed to target area, as shown in Figure 6, the distal end of microcatheter 10 is pushed to target area along guide wire 600,
  • Fig. 7 shows a partial schematic diagram of the microcatheter in the dotted box in FIG. 6 . As shown in FIG.
  • auxiliary wire 800 inserts the extended connection section 810 at the distal end of the auxiliary wire 800 to the proximal end of the microcatheter to ensure that the auxiliary wire 800 can stably abut against the proximal end of the microcatheter 10, and use the auxiliary wire 800 in vitro.
  • Wire 800 against the most proximal end of the microcatheter 10, as shown in Figure 9, with the help of auxiliary wire 800 can be The guide tube 700 and guide wire 600 are withdrawn without affecting the position of the microcatheter 10 in the body.
  • FIG. 11 is a structural schematic diagram of a detachable Luer connector 900 and its connection with the microcatheter syringe pump connector section 500.
  • the detachable Luer connector 900 includes a female connector 910 and a male connector 920 that are threaded into each other.
  • the female connector There is an extension part 911 in the 910, and an elastic fixing part 921 is arranged in the male connector 920.
  • the anticoagulant drug can flow out through the second side opening on the outside of the top of the arc shape, reducing the generation of thrombus at this part, and further
  • the anticoagulant performance of the microcatheter is optimized, so that when the microcatheter is placed in the artery, thrombus is not easy to grow on the wall of the vessel or the artery.
  • This embodiment discloses a microcatheter for local administration of cerebral blood vessels, which sequentially includes: a syringe pump joint section, a delivery section, an opening section, a fixing section and a terminal section from the proximal end to the distal end.
  • the length of the delivery section is 1.1m
  • the syringe pump joint section, delivery section, opening section and fixed section have a connected inner cavity
  • the outer diameter of the syringe pump joint section is 5.5F
  • the outer diameter of the opening section is 4F
  • the inner diameter of the inner cavity is 1.2mm
  • the end section is basically straight and has a length of 2mm, which can be free in the blood vessel and is convenient for microcatheter implantation.
  • the catheter can be placed in the body for a long time without causing hemolytic reactions and other adverse reactions, and can be administered through a high-pressure injection pump tube, wherein the delivery section and the opening section include a wire inner layer and a polycarbonate skin layer.
  • the overall shape of the microcatheter is shown in Figure 13, the conveying section 100, the opening section 300, and the end section 400 are substantially straight in the axial direction of the microcatheter, and the fixing section 200 has a preformed arc shape,
  • the arch height of the arc shape is 5 mm, and the span is 10 mm.
  • the arc shape relatively fixes the microcatheter in the blood vessel, so that the microcatheter does not shift and does not affect the blood flow, which is convenient for local administration.
  • the end of the fixed section close to the end section is blocked, so that the fixed section is not connected to the end section, and the opening section is provided with a first side opening on the initial section, and the first side
  • the opening is about 20mm from the end of the microcatheter so that the drug in the lumen can reach the target area through the first side opening area.
  • a second side opening is provided on the outer side of the arc-shaped top of the fixing section 200, so that anticoagulant drugs can flow out through the second side opening, preventing thrombus at this part, and further optimizing the anticoagulation of the microcatheter Blood performance, making the microcatheter placed in the artery is not easy to grow thrombus for a long time.
  • Markers are provided at the junctions of the opening section and the fixing section and at the junctions of the opening section and the delivery section to help the external device detect its position in the patient's body.
  • the end section is provided with a guidewire through hole, which can accommodate the guidewire for catheter setting.
  • the microcatheter enters the blood vessel along the guidewire.
  • the arc shape of the fixed section 200 makes the position between the microcatheter and the blood vessel relatively fixed.
  • the microcatheter The displacement is very small, does not damage the vascular intima, and does not affect blood flow.
  • microcatheters are selectively inserted into cerebral blood vessels (the diameter of cerebral blood vessels is 2-4mm), and the joint section of the syringe pump is fixed in vitro and connected with anticoagulant drugs to continuously pump anticoagulant Coagulation or antiplatelet drugs. Because of selective infusion, the drug dose will be reduced to 1/20-1/5 of the systemic dose. For patients with bleeding and bleeding tendencies, 2-15 days of non-anticoagulant/antiplatelet therapy can be sought.
  • This embodiment discloses a microcatheter for local administration to the liver, which sequentially comprises from the proximal end to the distal end: a syringe pump joint section, a delivery section, an opening section, a fixing section and a terminal section.
  • the length of the conveying section is 1.2m.
  • the joint section of the syringe pump, the conveying section, the opening section and the fixed section have a connected inner cavity.
  • the outer diameter of the joint section of the syringe pump is 5.5F.
  • the conveying section and the The outer diameter of the opening section is 5F, and the inner diameter of the inner cavity is 1.5mm;
  • the terminal section is basically straight and has a length of 20mm, which can be free in the blood vessel and is convenient for microcatheter implantation.
  • the catheter can be placed in the body for a long time without causing hemolytic reactions and other adverse reactions, and can be administered through a high-pressure injection pump tube, wherein the delivery section and the opening section include a wire inner
  • the overall shape of the micro-catheter is consistent with that of Example 3, the fixed section has a preformed arc shape, the bow height of the arc shape is 6mm, and the span is 12mm, and the arc shape is the same as that of the micro-catheter Relatively fixed in the blood vessel, the microcatheter does not shift and does not affect the blood flow, which is convenient for local administration.
  • the end of the fixed section close to the end section is blocked, so that the fixed section is not connected to the end section, and the opening section is provided with a first side opening on the initial section, and the first side
  • the opening is about 40 mm from the end of the microcatheter to allow drug in the lumen to reach the target area through the first side opening.
  • a second side opening is provided on the outer side of the top of the curved shape of the fixed section, so that anticoagulant drugs can flow out through the second side opening, preventing thrombus at this part, and further optimizing the anticoagulation of the microcatheter The performance makes it difficult for the microcatheter to form a thrombus for a long time in the artery.
  • Markers are provided at the junctions of the opening section and the fixing section and at the junctions of the opening section and the delivery section to help the external device detect its position in the patient's body.
  • the end section is provided with a guidewire through hole, which can accommodate the guidewire for catheter setting.
  • the arc shape of the fixed section 200 makes the position between the microcatheter and the blood vessel relatively fixed, and the displacement of the microcatheter is very small without damaging the blood vessel. Intima, which does not affect blood flow.
  • the inner and outer surfaces of the microcatheter are provided with an anticoagulant coating, which prevents thrombus from forming in the blood vessels of the liver.
  • an anticoagulant coating which prevents thrombus from forming in the blood vessels of the liver.
  • the microcatheter is selectively inserted into the tumor blood supply catheter (choose a certain hepatic lobe artery), and the chemotherapeutic drugs are selectively pumped in, which can play the role of local chemotherapy or selective chemical resection . Because of selective pump drugs, the total dose of chemotherapy can be reduced to 1/20-1/10 of the original dose, and the side effects of chemotherapy are significantly reduced.
  • Embodiment 5 animal experiments
  • This example provides an animal experiment on the microcatheter described in this application. This animal experiment was carried out at the Animal Experiment Center of Fuwai Hospital, Chinese Academy of Medical Sciences. The experiment started at 8:30 am on October 18, 2022 and ended on October 25. Finish.
  • Microcatheter 10 the microcatheter placed in the coronary artery for local administration, the specific structure and size are shown in Table 1;
  • Figure 14 is a schematic diagram of the assembly of the continuous administration part.
  • the one-way valve D, the three-way C, the anticoagulant liquid F and the infusion pump E are assembled.
  • the guide wire and guide catheter are routinely entered into the coronary ostium, and introduced Coronary guide wire (as shown in Figure 17, a model diagram of the position of the guide wire and guide catheter entering the coronary artery in Figure 17).
  • A is the guide catheter
  • B is the push-type Y valve
  • C is the three-way valve
  • D is the one-way valve
  • E is the infusion pump
  • F is the anticoagulant liquid
  • G is the pressure transducer channel
  • H is heparin saline Channel
  • I is the contrast agent
  • J is the guide wire.
  • Coronary indwelling microcatheter for local administration enters the human body: as shown in Figure 15 ( Figure 15 is a schematic diagram of coronary indwelling local administration microcatheter entering the human body), keep the pressing Y valve in a relaxed and leak-free state, and indwell the coronary artery The rapid exchange part at the head end of the local administration microcatheter 10 is sent into the guiding catheter along the coronary guide wire.
  • the microcatheter is placed in the coronary artery for local administration and delivered to the coronary artery: after the rapid exchange part enters the human body along the guide wire, it continues to be sent forward along the guiding catheter, and finally sent into the coronary artery (see Figure 16, Figure 18 , wherein, Fig. 16 is a schematic diagram showing the location of the microcatheter indwelling in the coronary artery for local administration to the coronary artery, and Fig. 18 is a simulation diagram of the microcatheter indwelling in the coronary artery for local administration in the coronary artery). Then attach the exchange guide wire to the tail of the microcatheter to fix its position. While keeping the microcatheter indwelling in the coronary arteries still, withdraw the guiding catheter. Only the coronary artery was left indwelling to place the local micromedicine catheter in the coronary artery.
  • Connecting the continuous drug administration part After removing the exchange guide wire from the tail of the microcatheter for local administration indwelling in the coronary artery, connect the exchange Luer connector 900. Connect the infusion tube of the infusion pump to maintain continuous administration.
  • the microcatheter includes in turn from the proximal end to the distal end: a syringe pump connector section, a delivery section, a fixed section, an opening section, and a terminal section, and the specific dimensions and opening settings are shown in Table 1 below:
  • the specific operation from the beginning of the experiment to the fixation of the microcatheter and turning over the experiment is as follows: percutaneously puncture the right femoral artery in the supine position, insert the 8F vascular sheath, and guide the 6F JR4.0 Guiding catheter with a J-shaped guide wire through the right femoral artery DA was performed to the left crown, the BMW guide wire guided the 3.0 ⁇ 28mm stent to the proximal end of the LAD for release, and the OCT examination showed that the stent was not completely attached to the wall. 2.5 ⁇ 12mm balloons, 2.75 ⁇ 12mm balloons, and 4.0 ⁇ 8mm balloons were used for expansion respectively.
  • the tested microcatheter was sent to the opening of the LAD, the Guiding catheter was withdrawn, and the microcatheter was fixed in vitro for local administration of coronary artery indwelling. Then carry out the turning experiment, after the pig in the supine position is turned sideways back and forth 5 times (the turning angle is about 180 degrees each time), observe the displacement of the microcatheter at the coronary artery, and observe that the position of the microcatheter is fixed, showing that the microcatheter can It is stably arranged at the coronary artery without displacement, and the fixing section has a preformed arc shape to achieve the expected goal of fixing the microcatheter.
  • Coronary indwelling microcatheter position for local administration can be effectively fixed at the coronary ostium position, which can provide reliable local drug delivery effect (as shown in Figure 19, Figure 19 shows that the microcatheter for local administration remains in the pig coronary artery for 36 hours location map).
  • the fixed section is provided with a preformed arc shape, which can keep the distal end of the microcatheter relatively fixed at the ostium of the coronary artery to infuse the medicinal solution.
  • the tail of the microcatheter is a special detachable Luer connector. After being connected with the extension guide wire, the large lumen guide catheter can be exited along the micro catheter-extension guide wire, so as to keep the micro catheter fixed in the coronary artery. Finally, connect the Luer connector, connect the infusion set, and perform intracoronary infusion therapy.
  • the ordinary microcatheter cannot be fixed in the coronary artery for a long period of time, and it cannot be withdrawn from the large lumen guide catheter while keeping the microcatheter still, so that the selectivity cannot be achieved and the purpose of intracoronary drug administration cannot be achieved. Since the outer surface of the microcatheter is provided with an MPC polyphosphorylcholine anticoagulant coating, no matter whether the blood is fully heparinized during the intervention operation, the formation of thrombus in the guiding catheter and the coronary artery can be significantly inhibited.
  • Embodiment 6 comparative example: animal experiment
  • This embodiment provides a comparative example of microcatheter animal experiments.
  • This animal experiment was implemented in the Animal Experiment Center of Fuwai Hospital, Chinese Academy of Medical Sciences.
  • the experimental animal was an 81 kg female British large white pig.
  • the experimental scheme was basically the same as in Example 5. , the difference is that there is no second side opening on the outside of the arc-shaped top of the fixed section of the microcatheter.
  • the experimental period is from June 28 to 29, 2022.
  • bilateral femoral arteries were percutaneously punctured into an 8F vascular sheath, and a 6F JR4.0 Guiding catheter was guided through the right femoral artery with a J-shaped guide wire to the left crown for DA, and a 3.5 ⁇ 28 stent was guided by a BMW guide wire to the proximal end of the LAD.
  • the OCT examination showed that the stent was well attached to the wall. Under fluoroscopy, the tested microcatheter was sent to the opening of the LAD, and 200u/hour of heparin was continuously pumped through the microcatheter.
  • the LAD microcatheter was withdrawn, and angiography was performed on the LAD.
  • the image showed thrombus formation at the distal end of the stent, and OCT was performed. Reimplant the LAD opening after replacing the microcatheter.
  • the aorta was dissected to expose the inner wall of the ascending aorta and the opening of the left coronary artery.
  • a thrombus was found on the wall of the ascending aorta, measuring 0.1*0.6cm and 0.1-1.2cm respectively. Cut longitudinally to the distal end to see the implanted stent, with a thrombus attached to the inner wall, 0.2*0.6cm. Dim myocardium can be seen at the distal end of the stent, 5*5cm.
  • a microcatheter was placed in the abdominal aorta and femoral artery, surrounded by glue-like substances, and a thrombus was seen in the femoral artery and inserted into the lower extremity sheath.

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Abstract

L'invention concerne un microcathéter pour administration locale comprenant, séquentiellement d'une extrémité proximale à une extrémité distale : une section de distribution (100), une section de fixation (200), une section perforée (300) et une section de fin (400). La section de distribution (100), la section de fixation (200) et la section perforée (300) définissent conjointement une cavité interne (110) et ont un diamètre externe de 1,5 F à 5 F et un diamètre interne de 0,4 mm à 1,5 mm. La section de fin (400) a une longueur de 1 à 40 mm et est pourvue d'un trou traversant de fil de guidage (610). La section de fixation (200) présente une forme d'arc préformée. La section perforée (300) possède une extrémité bloquée et est pourvue d'une première ouverture latérale (310). La section de fixation (200) est pourvue d'une seconde ouverture latérale (210) sur le côté externe au sommet de la forme d'arc. Lorsqu'il est placé dans une artère pendant une longue période, le microcathéter ne provoque pas facilement un thrombus. Le microcathéter est approprié pour être placé dans un corps pour une administration locale ou intraveineuse chez un patient souffrant d'une maladie vasculaire dans une artère coronaire, la tête, le foie, un rein, un poumon ou périphérique et similaire, et peut réduire la dose à moins de 20 % par rapport à une dose classique.
PCT/CN2023/073051 2022-02-15 2023-01-19 Microcathéter non traversant pour administration locale et instrument médical le comprenant WO2023155656A1 (fr)

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
CN202210138453.5 2022-02-15
CN202210138453.5A CN116637269A (zh) 2022-02-15 2022-02-15 一种用于局部给药的微导管及包含它的医疗器械
CN202210138434.2A CN116637268A (zh) 2022-02-15 2022-02-15 一种用于局部给药的非贯通微导管及包含它的医疗器械
CN202220303563.8 2022-02-15
CN202210138434.2 2022-02-15
CN202220302858.3U CN218607684U (zh) 2022-02-15 2022-02-15 一种用于局部给药的非贯通微导管及包含它的医疗器械
CN202220303563.8U CN219231114U (zh) 2022-02-15 2022-02-15 一种用于局部给药的微导管及包含它的医疗器械
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CN202222399075.4U CN219231191U (zh) 2022-09-09 2022-09-09 一种用于局部给药的贯通微导管及包含它的医疗器械
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CN202211100733.3A CN117679602A (zh) 2022-09-09 2022-09-09 一种用于局部给药的非贯通微导管及包含它的医疗器械
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US7449010B1 (en) * 2002-07-15 2008-11-11 Motoya Hayase Material removal catheter and method
CN204468971U (zh) * 2015-02-16 2015-07-15 田进文 一种用于逆向溶栓的快速交换双腔微导管
CN107374699A (zh) * 2017-09-05 2017-11-24 湖南瑞康通科技发展有限公司 一种支架输送装置及其使用方法
CN110141763A (zh) * 2019-05-30 2019-08-20 成都市第七人民医院 一种冠脉血流引导及药物注射多功能微导管
CN214260317U (zh) * 2020-11-09 2021-09-24 刘志忠 一种血管内治疗用导管

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7449010B1 (en) * 2002-07-15 2008-11-11 Motoya Hayase Material removal catheter and method
CN204468971U (zh) * 2015-02-16 2015-07-15 田进文 一种用于逆向溶栓的快速交换双腔微导管
CN107374699A (zh) * 2017-09-05 2017-11-24 湖南瑞康通科技发展有限公司 一种支架输送装置及其使用方法
CN110141763A (zh) * 2019-05-30 2019-08-20 成都市第七人民医院 一种冠脉血流引导及药物注射多功能微导管
CN214260317U (zh) * 2020-11-09 2021-09-24 刘志忠 一种血管内治疗用导管

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