WO2023236743A1 - Cathéter médical - Google Patents

Cathéter médical Download PDF

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Publication number
WO2023236743A1
WO2023236743A1 PCT/CN2023/094793 CN2023094793W WO2023236743A1 WO 2023236743 A1 WO2023236743 A1 WO 2023236743A1 CN 2023094793 W CN2023094793 W CN 2023094793W WO 2023236743 A1 WO2023236743 A1 WO 2023236743A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
channel
distal end
medical catheter
liquid
Prior art date
Application number
PCT/CN2023/094793
Other languages
English (en)
Chinese (zh)
Inventor
张权
龙平
唐劼
Original Assignee
上海博畅医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Application filed by 上海博畅医疗科技有限公司 filed Critical 上海博畅医疗科技有限公司
Publication of WO2023236743A1 publication Critical patent/WO2023236743A1/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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/0032—Multi-lumen catheters with stationary elements characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22001—Angioplasty, e.g. PCTA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to a medical catheter.
  • Vasoembolic diseases have always seriously endangered human health, especially cerebral vascular embolism, which can easily lead to patients with limb dysfunction, even loss of working ability, and inability to take care of themselves.
  • mechanical thrombectomy is a common method for treating vascular embolism, that is, the thrombus is captured by cutting a stent or a braided stent.
  • This method will have a series of problems: for example, it will produce tiny thrombus and cause distal vessel embolism; the stent will be released and removed during the process.
  • the embolization process it is easy to cause damage to the vascular endothelium and even complications such as vasospasm and dissection.
  • it is necessary to establish a guiding catheter, intermediate catheter, microcatheter and other channels, and then deliver the thrombectomy stent, which will prolong the operation time to a certain extent.
  • Catheter suction technology can improve the vascular recanalization rate and shorten the recanalization time. Since suction and thrombus removal does not require passing through the thrombus, and does not require distal operations of microcatheters and microguidewires, the use of suction technology is safe and effective, and is consistent with the equipment. The associated complications are lower than those with stent thrombectomy, and the treatment costs are also lower than those with stent thrombectomy.
  • thrombus the current aspiration technology also has certain shortcomings.
  • the components and shapes of thrombus are different, including soft and fragile fresh thrombus rich in red blood cells, hard white blood thrombus rich in fibrin, and even calcified thrombus, cardiogenic thrombus, etc. Thrombus, etc.
  • the volumes of different thrombi are also different, which will affect the suction effect, and even directly cause the catheter to be unable to extract the thrombus. Therefore, the suction catheters in the prior art often have low suction efficiency due to reasons such as small inner diameter of the catheter, large thrombus load, and hard texture of the thrombus. The thrombus cannot be extracted from the body through the suction catheter, seriously affecting the therapeutic effect.
  • the purpose of the present invention is to provide a medical catheter that improves thrombus aspiration efficiency and is suitable for removing thrombus of various shapes and textures.
  • An embodiment of the present invention provides a medical catheter, including:
  • the catheter seat includes a first communication interface and a second communication interface
  • Tube body the inside of the tube body is provided with a suction channel and a liquid channel, the proximal end of the suction channel is connected with the first communication interface, and the distal end of the suction channel is at the end of the tube body The distal end is open, the proximal end of the liquid channel is connected to the second communication interface, and the distal end of the liquid channel is connected to the distal end of the suction channel.
  • the suction channel and the liquid channel are respectively straight channels extending along the axial direction of the tube body; or, the suction channel is a straight channel extending along the axial direction of the tube body. channel, and the liquid channel is a spiral channel.
  • the tube body includes an outer layer and an inner layer located inside the outer layer, and both the suction channel and the liquid channel are opened in the inner layer.
  • the pipe body further includes a reinforcing layer located between the outer layer and the inner layer, the reinforcing layer including at least one of a hypotube, a braided layer, and a spiral layer.
  • the tube body includes an outer layer and an inner layer located inside the outer layer, the suction channel is opened in the inner layer, and is provided between the outer layer and the inner layer. There is a reinforcement layer, and the liquid channel is opened in the reinforcement layer.
  • the liquid channel is spirally arranged around the inner layer to form a spiral channel.
  • the reinforcing layer includes a braided layer and/or a spiral layer, the braided layer and/or the spiral layer is obtained by combining a hollow tube and a braided wire, and the liquid channel is the hollow tube. of the inner cavity.
  • the reinforcing layer includes a braided layer, the number of braided nodes per unit inch of the braided layer decreases from the proximal end to the distal end; and/or the reinforcing layer includes a helical layer, the helical layer The number of spirals per unit inch decreases from proximal to distal.
  • a developing component is provided at the distal end of the tube body, and the distal end of the hollow tube is fixed to the developing component.
  • the distal end of the hollow tube is provided with a liquid outlet hole
  • the liquid outlet hole is connected with the suction channel
  • the developing member is provided with a developing member opening
  • the developing member The opening is connected with the liquid outlet hole.
  • the outer diameter of the tube body gradually decreases from the proximal end to the distal end.
  • the proximal end of the outer layer is stiffer than the distal end of the outer layer.
  • the suction channel has a cross-sectional radial dimension of 0.03 inches to 0.14 inches
  • the liquid channel has a cross-sectional radial dimension of 0.014 inches to 0.056 inches
  • the medical catheter has an outer diameter is 0.07 inches-0.17 inches.
  • the distal end of the liquid channel is provided with a liquid outlet, the liquid outlet is connected to the suction channel, and the diameter of the liquid outlet is 0.002 inches to 0.01 inches.
  • the pressure of the liquid flowing out of the liquid hole is 2Mpa-7Mpa.
  • the cross-section of the suction channel is cashew-shaped, fan-shaped or arcuate, and the cross-section of the liquid channel is circular.
  • the medical catheter of the present invention contains both a suction channel and a liquid channel.
  • the liquid channel can provide high-speed fluid to impact the thrombus, causing the sucked thrombus to Fragmentation and deformation occur to change the shape and dilute the thrombus, making it easier to be extracted from the body through the suction channel. Therefore, the size of the thrombus that can be aspirated by this medical catheter is not limited by the inner diameter of the catheter, and the thrombus will not be unable to be extracted from the body due to the influence of the shape and structural components of the thrombus.
  • the medical catheter of the present invention can improve the success rate of thrombus aspiration, significantly improve the therapeutic effect, and expand the scope of indications; at the same time, the present invention can reduce the requirements for the inner diameter of the suction channel, and thus can set a smaller outer diameter of the catheter, making medical treatment more convenient.
  • the catheter is pushed to the distal end more easily and smoothly, improving the pushing performance of medical catheters.
  • the medical catheter of the present invention has a reinforced layer, and a liquid channel can be opened in the reinforced layer, thereby ensuring that the medical catheter can eject fluid and aspirate thrombus while still having good resistance to bending and ellipse. performance.
  • Figure 1 is a schematic diagram of the overall structure of a medical catheter according to a first embodiment of the present invention
  • Figure 2 is a schematic diagram of the tube body layering of the medical catheter according to the first embodiment of the present invention
  • Figure 3 is a schematic cross-sectional view of the medical catheter at the distal outlet of the first embodiment of the present invention
  • Figure 4 is a schematic diagram of the use of the medical catheter according to the first embodiment of the present invention.
  • Figure 5 is a partial enlarged schematic diagram of the use of the medical catheter according to the first embodiment of the present invention.
  • Figure 6 is a schematic diagram of the overall structure of the medical catheter according to the second embodiment of the present invention.
  • Figure 7 is a schematic diagram of the tube body layering of the medical catheter according to the second embodiment of the present invention.
  • Figure 8 is a schematic cross-sectional view of the connection between the distal end of the spiral hollow tube and the developing component according to the second embodiment of the present invention.
  • Figure 9 is a schematic diagram of the use of the medical catheter according to the second embodiment of the present invention.
  • Figure 10 is a partial enlarged schematic diagram of the use of the medical catheter according to the second embodiment of the present invention.
  • Example embodiments will now be described more fully with reference to the accompanying drawings.
  • Example embodiments may, however, be embodied in various forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concepts of the example embodiments.
  • the same reference numerals in the drawings represent the same or similar structures, and thus their repeated description will be omitted.
  • the words “or” and “or” in the description may mean “and” or “or”.
  • the terms “upper,””lower,””between,” etc. may be used in this specification to describe various exemplary features and elements of the invention, these terms are used herein for convenience only, such as in the drawings. direction of the example described.
  • any content in this manual Neither should be understood to require a specific three-dimensional orientation of a structure to fall within the scope of this invention.
  • first or second are used in this specification to refer to certain features, they are only used for expression purposes and serve as limitations on the number and importance of specific features.
  • the "radial dimension” referred to in the present invention refers to the distance between the two farthest points on the cross section. Taking the cross section as a circle as an example, the radial dimension is the diameter.
  • proximal end and distal end are relative to the operator, “proximal end” refers to the end close to the operator, and “distal end” refers to the end far away from the operator, that is, The end close to the surgical site, for example, in Figure 1, the proximal end of the tube body is the left end, and the distal end is the right end.
  • Axis refers to the axial direction of the tube body, that is, the horizontal direction from left to right in the perspective of Figure 1.
  • the present invention provides a medical catheter, which includes a catheter seat and a tube body.
  • the catheter seat is located on the proximal side of the tube body.
  • the catheter seat includes a first communication interface and a tube body. Second connectivity interface.
  • a suction channel and a liquid channel are provided inside the tube body, the proximal end of the suction channel is connected to the first communication interface, and the proximal end of the liquid channel is connected to the second communication interface, The distal end of the suction channel is opened at the distal end of the tube body, and the distal end of the liquid channel is connected with the suction channel.
  • the first communication interface can provide negative pressure for the suction channel, so that the suction channel can suction thrombus
  • the second communication interface can provide liquid input for the liquid channel, and the liquid channel is connected to the
  • the connecting position of the suction channel can eject high-speed fluid to impact the thrombus, causing the inhaled thrombus to break and deform to change its shape, and dilute the thrombus, making it suitable for being extracted from the body through the suction channel.
  • this medical catheter is not limited by the inner diameter of the catheter, and will not be affected by the shape and structural components of the thrombus that will prevent the thrombus from being extracted from the body. It can improve the success rate of thrombus aspiration, and is therefore suitable for removing various shapes and textures. of blood clots.
  • the present invention can reduce the requirements for the inner diameter of the suction channel, and can further set a smaller outer diameter of the catheter, making it easier and smoother to push the medical catheter to the distal end, and improving the pushing performance of the medical catheter.
  • Figures 1 to 5 show the specific structure and use process of the medical catheter 10 according to the first embodiment of the present invention.
  • the medical catheter 10 includes a catheter base 101 and a tube body 102 .
  • the catheter seat 101 is a Y-shaped seat located at the proximal end side of the tube body 102 .
  • the catheter adapter 101 includes a first communication interface 101b and a second communication interface 101a. Place
  • the tube body 102 is provided with a suction channel 1021 and a liquid channel 1022 inside.
  • the proximal end of the suction channel 1021 is connected to the first communication interface 101b.
  • the distal end of the suction channel 1021 is on the tube.
  • the distal end of the body 102 opens, the proximal end of the liquid channel 1022 is connected with the second communication interface 101a, and the distal end of the liquid channel 1022 is provided with a liquid outlet hole 1022a, and the liquid outlet hole 1022a is connected to the second communication interface 101a.
  • the suction channels 1021 are connected.
  • the first communication interface 101b can provide negative pressure for the suction channel 1021, so that the suction channel 1021 can suction the thrombus 104, and the second communication interface 101a can provide liquid input for the liquid channel 1022,
  • the location where the liquid channel 1022 communicates with the suction channel 1021 can eject high-speed fluid to impact the thrombus 104, causing the inhaled thrombus 104 to break and deform to change its shape, and can be diluted by the liquid, thereby making it suitable for passage.
  • the suction channel 1021 is drawn out of the body.
  • the medical catheter 10 is not limited by the inner diameter of the catheter, and will not be unable to extract the thrombus 104 from the body due to the influence of the shape and structural components of the thrombus 104. It can improve the success rate of aspiration of the thrombus 104, and is therefore suitable for removing various types of thrombus 104. Various shapes and textures of thrombus 104.
  • the tube body 102 is formed as a double-lumen tube, and the suction channel 1021 and the liquid channel 1022 are respectively straight channels extending along the axial direction of the tube body 102 , and the suction channel 1021 and the liquid channel respectively penetrate the tube body 102 along the axial direction.
  • the distal end of the tube body 102 is provided with a developing component 1023 indicating the position of the distal end of the tube body 102.
  • the developing component 1023 is, for example, a developing ring, a developing strip, or other shapes.
  • the outer diameter of the tube body 102 gradually becomes smaller from the proximal end to the distal end, so as to gradually increase the flexibility of the tube body 102 from the proximal end to the distal end, and can improve the access of the tube body 102 to The ability of small blood vessels 103 (such as the distal intracranial small blood vessels 103).
  • the pipe body 102 includes an outer layer 102a, a reinforcement layer 102b and an inner layer 102c arranged in sequence from the outside to the inside.
  • the proximal hardness of the outer layer 102a is greater than the distal hardness, and preferably the hardness gradually decreases from the proximal end to the distal end, for example, gradually decreases from 72D to 55A.
  • the greater hardness of the proximal end of the outer layer 102a ensures that the proximal end of the tube body 102 In addition to the bending resistance and pushing performance, the smaller hardness of the distal end of the outer layer 102a improves the flexibility of the distal end of the tube body 102, making it easier for the tube body 102 to reach the tortuous diseased blood vessel 103.
  • the outer layer 102a may be made of medical polymer materials such as TPU (thermoplastic polyurethane elastomer rubber), Nylon (nylon), Pebax (nylon elastomer), etc.
  • the reinforcement layer 102b Can include one or more layers of material. The reinforcement layer 102b can improve the bending resistance, ellipse resistance, etc.
  • the multi-layer material of the reinforcement layer 102b may include one or more of a braided layer, a spiral layer, and a hypotube.
  • a hypotube is a long metal tube with micro-engineered features throughout its entire length. The surface of the hypotube may be engraved with patterns.
  • the braided wire 1024 or hypotube used in the braided layer and/or spiral layer can be made of stainless steel, nickel-titanium and other metal materials, or LCP (liquid crystal polymer), PI (polyimide), aramid, polyester and other medical high-tech materials. Molecular materials.
  • this embodiment is explained by taking the reinforcing layer 102b including a spiral layer as an example.
  • the spiral layer one or more braided wires are spirally wound around the outside of the inner layer 102c to form a spiral structure.
  • the number of spirals per unit inch of the spiral structure decreases from the proximal end to the distal end to increase the hardness of the proximal end and the distal end.
  • the flexibility of the end ensures the bending resistance and pushing performance of the proximal end of the tube body 102, and by improving the flexibility of the distal end of the tube body 102, it is easier to reach the tortuous diseased blood vessel 103.
  • the reinforcing layer 102b includes a hypotube
  • the hardness of the hypotube decreases sequentially from the proximal end to the distal end.
  • the reinforcement layer 102b includes a braided layer
  • the PPI (number of braided nodes per unit inch) of the braided structure decreases from the proximal end to the distal end.
  • the material of the inner layer 102c can be medical polymer materials with high pressure resistance such as Pebax (nylon elastomer), PET (polyethylene terephthalate), or PTFE (polytetrafluoroethylene), FEP (fluoroethylene propylene copolymer), HDPE (high-density polyethylene), POM (polyoxymethylene) and other medical polymer materials with low friction coefficients can reduce the frictional resistance when delivering equipment or aspirating thrombus 104.
  • the suction channel 1021 and the liquid channel 1022 are both opened in the inner layer 102c.
  • the suction channel 1021 has a fan-shaped cross section, and the liquid channel 1022 has a circular cross section.
  • a liquid outlet hole 1022a is provided at the distal end of the suction channel 1021 and the liquid channel 1022, and the liquid outlet hole 1022a is connected to the suction channel 1021 and the liquid channel 1022 at the same time.
  • the cross section of the liquid outlet hole 1022a is an axially symmetrical figure, and the angle between both sides of the liquid outlet hole 1022a and the central axis is ⁇ .
  • the size of the angle ⁇ can be determined according to the liquid channel 1022
  • the inner diameter, the speed required when the liquid rushes out of the liquid outlet 1022a, etc. are determined.
  • the liquid outlet hole 1022a of the liquid channel 1022 and the liquid channel The distance between the farthest end of 1022 is 0.01 inches to 0.03 inches, or it can also be set at the farthest end of the liquid channel 1022.
  • the diameter of the liquid outlet hole 1022a is smaller than the inner diameter of the liquid channel 1022a, so that the liquid is throttled and has a higher speed when passing through the liquid outlet hole 1022a from the liquid channel 1022a.
  • the liquid outlet hole 1022a is connected with the suction channel 1021, and the radial dimension of the cross-section of the suction channel is 0.03 inches to 0.14 inches.
  • the liquid channel 1022 has a cross-sectional radial dimension ranging from 0.014 inches to 0.056 inches.
  • the medical catheter has an outer diameter of 0.07 inches to 0.17 inches.
  • the diameter of the liquid outlet hole 1022a may be 0.002 inch to 0.01 inch, and the pressure of the liquid flowing out of the liquid outlet hole 1022a is 2Mpa to 7Mpa.
  • the dimensions listed here are only examples, and the present invention is not limited thereto.
  • the distance between the liquid outlet hole 1022a and the farthest end of the liquid channel 1022, the inner diameter of the suction channel 1021, the The values of the inner diameter and outer diameter of the liquid channel 1022 and the hole diameter of the liquid outlet hole 1022a can be selected and set according to needs.
  • the method of using the medical catheter 10 of this embodiment will be described in detail below with reference to FIGS. 4 and 5 .
  • the medical catheter 10 of this embodiment, the microcatheter, and the guidewire are alternately ascended through the coaxial technique to reach the occlusion position of the blood vessel 103.
  • the microcatheter and the guidewire are withdrawn, and the third
  • the two communication interfaces 101a are connected to external fluids, which may be physiological saline, heparinized physiological saline, thrombolytic drugs, etc.
  • the first communication interface 101b is connected to an external negative pressure source (such as a suction pump, a syringe, etc.).
  • the external negative pressure source continuously generates negative pressure on the suction channel 1021 through the first communication interface 101b, and the suction channel 1021 absorbs the thrombus 104 to its distal end.
  • the external fluid flows into the liquid channel 1022 through the second communication interface 101a, and continuously generates fluid pressure. After the fluid is throttled by the distal liquid outlet 1022a, it will pass from the liquid channel 1022 through the liquid outlet at high pressure and high speed.
  • the suction channel 1022a is sprayed to the far end of the suction channel 1021, and impacts the thrombus 104 that is sucked into the suction channel 1021 by the external negative pressure, causing the sucked thrombus 104 to instantly break and deform, and the thrombus 104 becomes small and diluted by the liquid. It is easily pulled out of the body by the negative pressure in the suction channel 1021. At the same time, the part of the thrombus 104 in the blood vessel 103 that is larger than the inner diameter of the suction channel 1021 will be stuck at the distal end of the tube body 102. This part of the thrombus 104 will be deformed and broken by the high-speed and high-pressure external fluid.
  • Figures 6 to 10 show the specific structure and use process of the medical catheter 10 according to the second embodiment of the present invention.
  • the medical catheter 10 includes a catheter adapter 101 and tube body 102.
  • the catheter seat 101 is a Y-shaped seat located at the proximal end side of the tube body 102 .
  • the tube body 102 includes a suction channel 1021 and a spiral channel.
  • the suction channel 1021 is a straight channel extending along the axial direction of the tube body 102 and passing through the tube body 102 along the axial direction.
  • the liquid channel 1022 is a spiral channel, and the liquid channel 1022 is a spiral channel. Penetrating the tube wall of the tube body 102, the spiral structure of the spiral channel also penetrates the tube body 102 along the axial direction.
  • the catheter adapter 101 includes a first communication interface 101b and a second communication interface 101a.
  • the proximal end of the suction channel 1021 is connected with the first communication interface 101b, and the first communication interface 101b provides negative pressure for the suction channel 1021 to achieve thrombus aspiration.
  • the distal end of the suction channel 1021 opens at the distal end of the tube body 102 .
  • the proximal end of the liquid channel 1022 is connected to the second communication interface 101a, and liquid can be injected into the liquid channel 1022 through the second communication interface 101a.
  • a liquid outlet hole 1022a is provided at the far end of the liquid channel 1022.
  • the liquid outlet hole 1022a is connected with the suction channel 1021, and the aperture of the liquid outlet hole 1022a is smaller than the inner diameter of the liquid channel 1022, so that When the liquid passes through the liquid outlet hole 1022a from the liquid channel 1022, it is throttled and has a higher speed, so that the liquid in the liquid channel 1022 can enter the far end of the suction channel 1021 through the liquid outlet hole 1022a at high speed and high pressure. end, impacting and diluting the thrombus.
  • a developing component 1023 is provided at the distal end of the tube body 102.
  • the developing component 1023 may be, for example, a developing ring, a developing strip, or other shapes.
  • the outer diameter of the tube body 102 gradually becomes smaller from the proximal end to the distal end, so as to gradually increase the flexibility of the tube body 102 from the proximal end to the distal end, and can improve the catheter's access to small blood vessels. 103 (such as the ability of small distal intracranial blood vessels 103).
  • the pipe body 102 includes an outer layer 102a, a reinforcing layer 102b and an inner layer 102c arranged in sequence from the outside to the inside.
  • the proximal hardness of the outer layer 102a is greater than the distal hardness, and preferably the hardness gradually decreases from the proximal end to the distal end, for example, gradually decreases from 72D to 55A.
  • the lower hardness of the proximal end of the outer layer 102a ensures that the proximal end of the tube body 102 In addition to the bending resistance and pushing performance, the higher hardness of the distal end of the outer layer 102a improves the flexibility of the distal end of the tube body 102, making it easier for the tube body 102 to reach the tortuous diseased blood vessel 103.
  • the outer layer 102a may be made of medical polymer materials such as TPU (thermoplastic polyurethane elastomer rubber), Nylon (nylon), Pebax (nylon elastomer), etc.
  • the reinforcement layer 102b may include one or more layers of material.
  • the reinforcement layer 102b can improve the bending resistance, ellipse resistance and other capabilities of the tube body 102, and also realize the transition of the overall hardness of the tube body 102 from the proximal end to the distal end, and even Improve the tensile resistance and other properties of the pipe body 102.
  • the multi-layer material of the reinforcement layer 102b may include one or more of a braided layer, a spiral layer, and a hypotube. The surface of the hypotube may be engraved with patterns.
  • the braided wire 1024 or hypotube used in the braided layer and/or spiral layer can be made of stainless steel, nickel-titanium and other metal materials, or LCP (liquid crystal polymer), PI (polyimide), aramid, polyester and other medical high-tech materials. Molecular materials.
  • the reinforcement layer 102b includes a spiral layer
  • at least one braided wire is spirally wound around the outside of the inner layer 102c to form a spiral structure.
  • the PPI (number of spirals per unit inch) of the spiral structure decreases from the proximal end to the distal end.
  • the bending resistance and pushing performance of the proximal end of the tube body 102 are ensured, and the tube body 102 can easily reach the tortuous diseased blood vessel 103.
  • the reinforcing layer 102b includes a hypotube
  • the hardness of the hypotube decreases sequentially from the proximal end to the distal end.
  • the number of braided nodes per unit inch of the braided structure decreases from the proximal end to the distal end.
  • the reinforcing layer 102b includes a spiral layer formed by braided wires 1024 and hollow tubes spirally wound in parallel on the outside of the inner layer 102c.
  • the liquid channel 1022 is opened inside the hollow tube, so that the liquid channel 1022 is spirally wound around the outside of the inner layer 102c.
  • the number of spirals per unit inch of the spiral layer is sequentially reduced from the proximal end to the distal end to improve the hardness of the proximal end of the tube body 102 and the flexibility of the distal end.
  • the material of the hollow tube can be the same as or different from the material of the braided wire 1024, such as stainless steel, nickel titanium and other metal materials, or LCP (liquid crystal polymer), PI (polyimide), aramid, polyester and other medical high-tech materials. Molecular materials.
  • the reinforcement layer 102b may also include a combination of a braided layer formed by braiding wires and a spiral layer formed by spiral winding of a hollow tube.
  • the hollow tube is spirally wound around the outside of the inner layer 102c.
  • the braided wire is braided to form a braided layer.
  • the braided layer is wrapped around the outside of the spiral hollow tube, and the number of braided nodes per unit inch of the braided layer is successively reduced from the proximal end to the distal end to improve the proximal end of the tube body 102. Stiffness and distal compliance.
  • the developing component 1023 is a developing ring.
  • the developing ring has a developing component opening 1023a.
  • the distal end of the hollow tube is connected to the developing component opening 1023a on the developing component 1023, that is, the distal liquid outlet hole 1022a of the hollow tube is fixed on the developing component opening 1023a and is connected to the suction channel 1021 Connected. Therefore, when passing through the second communication interface 101a When continuous high-speed fluid is injected into the hollow tube, the distal liquid outlet hole 1022a of the hollow tube is fixed on the developing component 1023, so that instability will not occur due to the low hardness of the outer layer 102a at the distal end.
  • the effect of removing the thrombus 104 will not be affected by the instability of the distal end of the tube body 102 .
  • the inner diameter of the hollow tube is 0.014 inches to 0.04 inches, and the outer diameter is 0.03 inches to 0.056 inches.
  • the inner diameters of the liquid outlet hole 1022a and the suction channel 1021 may be the same as those in the first embodiment, but are not limited thereto, and other values may be adopted according to clinical needs.
  • the material of the inner layer 102c can be medical polymer materials with high pressure resistance such as Pebax (nylon elastomer), PET (polyethylene terephthalate), or PTFE (polytetrafluoroethylene), FEP (fluoroethylene propylene copolymer), HDPE (high-density polyethylene), POM (polyoxymethylene) and other medical polymer materials with low friction coefficients can reduce the frictional resistance when delivering equipment or aspirating thrombus 104.
  • medical polymer materials with high pressure resistance such as Pebax (nylon elastomer), PET (polyethylene terephthalate), or PTFE (polytetrafluoroethylene), FEP (fluoroethylene propylene copolymer), HDPE (high-density polyethylene), POM (polyoxymethylene) and other medical polymer materials with low friction coefficients can reduce the frictional resistance when delivering equipment or aspirating thrombus 104.
  • the method of using the medical catheter 10 of this embodiment will be described in detail below with reference to FIGS. 9 and 10 .
  • the medical catheter 10 of this embodiment, the microcatheter, and the guidewire are alternately ascended through the coaxial technique to reach the occlusion position of the blood vessel 103.
  • the microcatheter and the guidewire are withdrawn, and the third
  • the two communication interfaces 101a are connected to external fluids, which may be physiological saline, heparinized physiological saline, thrombolytic drugs, etc.
  • the first communication interface 101b is connected to an external negative pressure source (such as a suction pump, a syringe, etc.).
  • the external negative pressure source continuously generates negative pressure on the suction channel 1021 through the first communication interface 101b, and the suction channel 1021 absorbs the thrombus 104 to its distal end.
  • the external fluid flows into the liquid channel 1022 through the second communication interface 101a, and continuously generates fluid pressure. After the fluid is throttled by the distal liquid outlet 1022a, it will pass from the liquid channel 1022 through the liquid outlet at high pressure and high speed.
  • the suction channel 1022a is sprayed to the far end of the suction channel 1021, and impacts the thrombus 104 that is sucked into the suction channel 1021 by the external negative pressure, causing the sucked thrombus 104 to instantly break and deform, and the thrombus 104 becomes small and diluted by the liquid. It is easily pulled out of the body by the negative pressure in the suction channel 1021. At the same time, the part of the thrombus 104 in the blood vessel 103 that is larger than the inner diameter of the suction channel 1021 will be stuck at the distal end of the tube body 102. This part of the thrombus 104 will be deformed and broken by the high-speed and high-pressure external fluid.

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Abstract

L'invention concerne un cathéter médical (10), comprenant : un raccord de cathéter (101), comportant une première interface de communication (101b) et une seconde interface de communication (101a) ; et un corps de cathéter (102), un canal d'aspiration (1021) et un canal de liquide (1022) étant disposés à l'intérieur du corps de cathéter (102), une extrémité proximale du canal d'aspiration (1021) étant en communication avec la première interface de communication (101b), une extrémité distale du canal d'aspiration (1021) étant ouverte à une extrémité distale du corps de cathéter (102), une extrémité proximale du canal de liquide (1022) étant en communication avec la seconde interface de communication (101a), et une extrémité distale du canal de liquide (1022) étant en communication avec l'extrémité distale du canal d'aspiration (1021). L'utilisation du cathéter médical (10) permet d'améliorer l'efficacité de l'aspiration des thrombus et le cathéter médical est adapté à l'élimination des thrombus de différentes formes et textures.
PCT/CN2023/094793 2022-06-10 2023-05-17 Cathéter médical WO2023236743A1 (fr)

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CN202210655314.XA CN117244160A (zh) 2022-06-10 2022-06-10 医疗导管

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040193046A1 (en) * 2003-03-28 2004-09-30 John E. Nash Catheter with associated extension lumen
CN106163429A (zh) * 2014-04-08 2016-11-23 英丘维特有限责任公司 管理血栓形成的系统和方法
CN109152583A (zh) * 2016-04-06 2019-01-04 沃克血管有限公司 用于溶解血栓和传送药剂的系统和方法
CN113876392A (zh) * 2021-11-09 2022-01-04 北京深瑞达医疗科技有限公司 一种血栓抽吸组件
CN114246637A (zh) * 2020-11-05 2022-03-29 玮铭医疗器械(上海)有限公司 一种颅内血栓抽吸导管装置
WO2022104374A1 (fr) * 2020-11-13 2022-05-19 Microvention, Inc. Cathéter d'aspiration distal et procédé
CN217724321U (zh) * 2022-06-10 2022-11-04 上海博畅医疗科技有限公司 医疗导管

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040193046A1 (en) * 2003-03-28 2004-09-30 John E. Nash Catheter with associated extension lumen
CN106163429A (zh) * 2014-04-08 2016-11-23 英丘维特有限责任公司 管理血栓形成的系统和方法
CN109152583A (zh) * 2016-04-06 2019-01-04 沃克血管有限公司 用于溶解血栓和传送药剂的系统和方法
CN114246637A (zh) * 2020-11-05 2022-03-29 玮铭医疗器械(上海)有限公司 一种颅内血栓抽吸导管装置
WO2022104374A1 (fr) * 2020-11-13 2022-05-19 Microvention, Inc. Cathéter d'aspiration distal et procédé
CN113876392A (zh) * 2021-11-09 2022-01-04 北京深瑞达医疗科技有限公司 一种血栓抽吸组件
CN217724321U (zh) * 2022-06-10 2022-11-04 上海博畅医疗科技有限公司 医疗导管

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