WO2024000758A1 - 医疗器械 - Google Patents

医疗器械 Download PDF

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Publication number
WO2024000758A1
WO2024000758A1 PCT/CN2022/113041 CN2022113041W WO2024000758A1 WO 2024000758 A1 WO2024000758 A1 WO 2024000758A1 CN 2022113041 W CN2022113041 W CN 2022113041W WO 2024000758 A1 WO2024000758 A1 WO 2024000758A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
medical device
support
catheter
inner tube
Prior art date
Application number
PCT/CN2022/113041
Other languages
English (en)
French (fr)
Inventor
李剑青
谢超宇
卢飞
李俊菲
Original Assignee
微创投资控股有限公司
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Publication of WO2024000758A1 publication Critical patent/WO2024000758A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/35—Medical purposes thereof other than the enhancement of the cardiac output for specific surgeries, e.g. for Fontan procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/827—Sealings between moving parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/091—Guide wires having a lumen for drug delivery or suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/04—General characteristics of the apparatus implanted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/366—General characteristics of the apparatus related to heating or cooling by liquid heat exchangers
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system

Definitions

  • This application relates to the technical field of medical devices, and in particular to a medical device.
  • blood pumps are mainly used for emergency treatment of cardiogenic shock and auxiliary circulation during high-risk PCI (percutaneous coronary intervention) surgery.
  • a blood pump placed on the aortic valve can provide flow support up to 4L/min, thereby replacing the pumping function of the heart, saving the lives of patients with cardiogenic shock, or stabilizing the heart condition during high-risk PCI patients. , reduce the occurrence of arrhythmias, thereby reducing surgical risks and ensuring the success rate of high-risk PCI surgeries.
  • the blood pump can be a percutaneous interventional blood pump, and the intervention method is through femoral artery puncture surgery.
  • the guidewire is first inserted into the body through the femoral artery, and after reaching the valve position through the aorta and aortic arch, the guidewire crosses the valve and enters the heart.
  • the part of the guide wire located outside the body is then inserted into the distal end of the blood pump, so that the blood pump can enter the body under the guidance of the guide wire and finally reach the ventricle.
  • the foldable pump component of this type of blood pump is made of a collapsible material. It enters the heart through the outer sheath. When it is removed from the outer sheath, the foldable pump component unfolds and is fixed on the aortic valve. , to achieve blood pumping function.
  • This application provides a medical device, including:
  • a foldable pump assembly is connected to the proximal end of the catheter.
  • the foldable pump assembly includes a support net, a paddle, and a rotating shaft for driving the paddle to rotate.
  • the support net is configured to cover the
  • the peripheral side of the paddle is capable of radial expansion and contraction, the rotation axis has a first guidewire lumen connected to the catheter, the first guidewire lumen is configured to allow a guidewire to pass through, and The first guidewire lumen is capable of outputting perfusate from the distal end; and
  • a sealing structure is connected to the catheter, the sealing structure is configured to allow the guide wire to pass through and to seal the catheter when the guide wire is removed.
  • Figure 1 is a schematic structural diagram of a blood pump according to an embodiment of the present application.
  • Figure 2 is a schematic cross-sectional view of a partial structure of a blood pump according to an embodiment
  • Figure 3 is a partial enlarged schematic diagram of the structure of part A in Figure 2;
  • Figure 4 is a partial enlarged schematic diagram of the structure of part B in Figure 2;
  • Figure 5 is a schematic structural diagram of the first seal in the blood pump according to one embodiment
  • Figure 6 is a schematic structural diagram of the first seal in the blood pump according to another embodiment
  • Figure 7 is a schematic structural diagram of the first seal in the blood pump shown in Figure 6 from another perspective;
  • Figure 8 is a schematic diagram of the connection between the foldable pump assembly and the catheter in the blood pump according to one embodiment
  • Figure 9 is a partial structural cross-sectional view of the outer sheath tube, inner tube and transmission shaft in the blood pump according to one embodiment
  • Figure 10 is a schematic structural diagram of the foldable pump assembly of the blood pump according to one embodiment when it is located outside the outer sheath;
  • Figure 11 is a schematic structural diagram of the foldable pump assembly of the blood pump shown in Figure 10 when it is received in the outer sheath tube;
  • Figure 12 is a schematic structural diagram of the second support member of the blood pump according to one embodiment
  • Figure 13 is a schematic cross-sectional structural view of the second support member of the blood pump according to one embodiment
  • Figure 14 is a schematic structural diagram of another embodiment of the blood pump in which the foldable pump assembly is received outside the outer sheath;
  • Figure 15 is a schematic cross-sectional structural view of the foldable pump assembly of the blood pump according to one embodiment when it is received in the outer sheath;
  • Figure 16 is a schematic cross-sectional structural diagram of a catheter of a blood pump according to an embodiment
  • Figure 17 is a schematic structural diagram of the sealing structure at the distal end of the catheter of the blood pump shown in Figure 16 before assembly;
  • Figure 18 is a structural schematic diagram of the assembled distal sealing structure of the catheter of the blood pump shown in Figure 17;
  • Figure 19 is a schematic structural diagram of the guide wire passing through the distal end of the catheter and the sealing structure.
  • distal and proximal are used as directional terms, which are commonly used terms in the field of interventional medical devices.
  • distal refers to the end far away from the operator during the operation
  • proximal refers to The end closest to the operator during surgery.
  • Axial direction refers to the direction parallel to the line connecting the distal center and proximal center of the medical device;
  • radial direction refers to the direction perpendicular to the above-mentioned axial direction.
  • a medical device 10 provided by this application can be inserted into the body through percutaneous intervention and used for first aid in cardiogenic shock and assisted circulation during high-risk PCI surgery.
  • Medical device 10 includes catheter 11, collapsible pump assembly 12, and sealing structure.
  • the distal end of the catheter 11 may be a pig tail-shaped end or a J-shaped end. Since the end of this type of catheter 11 is curved like a pig's tail, this type of catheter 11 is usually referred to as a "pig tail tube" or "J-shaped catheter". ".
  • the proximal end of the catheter 11 is connected to the foldable pump assembly 12. When the foldable pump assembly 12 is inserted into the body and fixed, the catheter 11 can prevent damage to blood vessels and ventricular walls. Moreover, the catheter 11 can be passed through by the guide wire 10a, so that the guide wire 10a can be used for guidance to facilitate percutaneous interventional operations.
  • the foldable pump assembly 12 includes a paddle 121 and a rotating shaft 122 for driving the paddle 121 to rotate.
  • the rotating shaft 122 has a first guidewire lumen 122a connected with the catheter 11, so that the guidewire 10a can penetrate into the second guidewire lumen 122a through the catheter 11.
  • the first guidewire lumen 122a can output perfusion fluid from the distal end to cool or lubricate the rotating shaft 122.
  • the foldable pump assembly 12 includes a support net 123 that is configured to cover the circumferential side of the paddle 121 and can expand and contract radially.
  • the support network 123 When the support network 123 is in an expanded state, it can support the blood vessel wall and define the rotation space of the blade 121 to prevent the blade 121 from scratching the vascular tissue during rotation.
  • the support network 123 as a part of the foldable pump assembly 12, can adapt to the folding needs, so as to maintain a small delivery diameter during the insertion of the medical device 10 into the body, so as to reduce the wound.
  • the support net 123 may be made of memory alloy materials such as nickel-titanium alloy or cobalt-chromium alloy, which is not limited here.
  • the sealing structure is connected to the catheter 11 and is configured to allow the guide wire 10a to pass through and to seal the catheter 11 when the guide wire 10a is removed. Therefore, the sealing structure will not prevent the guide wire 10a from entering the first guide wire cavity 122a of the rotating shaft 122 from the catheter 11, so that the guide wire 10a can exert a good guiding effect on the catheter 11 and the foldable pump assembly 12.
  • the medical device When 10 enters the body for work, even if the guidewire 10a is removed from the sealing structure, the sealing structure can maintain the sealing of the catheter 11, so that the distal end of the first guidewire cavity 122a outputs perfusion fluid to cool or lubricate the rotating shaft 122.
  • the perfusion fluid will not enter the body from the catheter 11 and cause an increase in the patient's heart load. Therefore, using this medical device 10 can effectively reduce surgical risks. Understandably, since the sealing structure can maintain the sealing against the catheter 11 when the guidewire 10a is removed, blood will not enter the first guidewire lumen 122a from the catheter 11 during the operation of the medical device 10.
  • the catheter 11 is a polymer hose
  • the material may be a polymer material such as thermoplastic polyurethane elastomer rubber or block polyetheramide resin to reduce damage to percutaneous tissue.
  • sealing structure may be directly connected to the catheter 11, or may be indirectly connected to the catheter 11 through other structural components, as long as the sealing structure can meet the need for the guide wire 10a to pass through, and the sealing structure can be removed after the guide wire 10d is removed. It is sufficient that the conduit 11 can be sealed. Sealing the catheter 11 here includes, but is not limited to, sealing at the distal end of the catheter 11 or at the proximal end of the catheter 11 .
  • the sealing structure is disposed at the proximal end of the catheter 11 , specifically, the sealing structure is disposed between the catheter 11 and the rotation shaft 122 .
  • the medical device 10 includes a first support component 15 and a second support component 16 .
  • the first support component 15 is fixedly connected to the distal end of the support network 123
  • the second support component 16 is connected to the distal end of the support network 123 .
  • the proximal ends are fixedly connected, and the first support component 15 and the second support component 16 are configured to jointly support the rotation shaft 122 and allow the rotation shaft 122 to rotate.
  • the first support component 15 and the second support component 16 are rotatably connected to the distal end and the proximal end of the rotation shaft 122 respectively, thereby achieving stable support for the rotation shaft 122 and meeting the rotation needs of the rotation shaft 122 to enhance the rotation. Rotational stability of shaft 122.
  • the first support component 15 is at least partially disposed between the rotating shaft 122 and the conduit 11 .
  • the first support component 15 and the conduit 11 can be connected by glue bonding, welding or hot melt connection.
  • the distal end of the support network 123 may be connected to the first support component 15 through glue bonding, welding or hot melt connection.
  • the first support assembly 15 has a wire passage for communicating the catheter 11 and the first guidewire lumen 122 a.
  • the sealing structure includes a first seal 151 disposed in the wire passage.
  • the first seal 151 is It is configured to allow the guide wire 10a to pass through the wire passage and to seal the wire passage when the guide wire 10a is removed.
  • the first seal 151 can adapt to the need for the guide wire 10a to enter the first guide wire cavity 122a from the catheter 11, allowing the guide wire 10a to pass through the rotating shaft 122 to lift the foldable pump assembly 122
  • the guiding effect reduces the difficulty of interventional surgery; on the other hand, after the guide wire 10a is removed, there is good sealing between the catheter 11 and the first guide wire cavity 122a, so that when the medical device 10 is used, blood will not flow from the catheter 11 Enter the first guide wire chamber 122a, and the perfusion fluid entering the first guide wire chamber 122a will not enter the body from the catheter 11 to prevent excessive perfusion volume from increasing the patient's cardiac load. Therefore, adopting this structural arrangement effectively reduces Surgical Risks.
  • the first support assembly 15 includes a first support member 152 and a second support member 153 connected to each other, the first support member 152 is connected to the conduit 11 , and the first support member 152 has a first through hole 152a , to communicate with the conduit 11.
  • the second support member 153 is connected to the rotation shaft 122, and the second support member 153 has a second through hole 153a, and the second through hole 153a is connected with the first guidewire cavity 122a. Therefore, when the first through hole 152a and the second through hole 153a are not connected to each other, the catheter 11 and the first guide wire lumen 122a are not connected to each other, and then the liquid cannot flow between them.
  • the use of the upper and lower split first support component 15 facilitates the installation of the first sealing structure while maintaining the coaxiality of the first support component 15 and the rotating shaft 122 .
  • first support component 15 can also be an integrally formed structure, which can be understood as the first support member 152 and the second support member 153 are integrally formed, that is, the distal end of the first support component 15 is connected to the catheter 11, and the first support member 152 and the second support member 153 are integrally formed.
  • the proximal end of the support component 15 is connected to the rotating shaft 122 .
  • the first seal 151 is preferably made of highly elastic material. It enters the first support component 15 through the wire channel and automatically pops up to be embedded in the first support component 15 .
  • the diameters of the first through hole 152a and the second through hole 153a may be 0.2 mm to 1.0 mm, and are not limited here, as long as they can meet the need for the guide wire 10a to pass through.
  • the apertures of the first guide wire cavity 122a, the second guide wire cavity 13a and the third guide wire cavity mentioned above are sufficient as long as they can meet the need for the guide wire 10a to pass through, and the specific aperture sizes are not limited here.
  • An installation cavity is formed between the first support member 152 and the second support member 153.
  • the first through hole 152a and the second through hole 153a are both connected with the installation cavity, and the three together form a wire passage.
  • the first sealing member 151 is disposed in the installation cavity.
  • the first supporting member 152 and the second supporting member 153 are used to improve the installation stability and convenience of the first sealing member 151 .
  • the first sealing member 151 plays a sealing effect between the first through hole 152a and the second through hole 153a, so that the liquid cannot flow between the catheter 11 and the first guide wire cavity 122a.
  • the blood in the body cannot enter the first guidewire chamber 122a from the catheter 11, and the perfusion fluid flowing into the first guidewire chamber 122a cannot enter the catheter 11.
  • the first support member 152 and the second support member 153 can be conveniently connected to the conduit 11 and the rotation shaft 122 .
  • the first support member 152 can be plug-fitted with the proximal end of the catheter 11 and improve the connection stability between the two through glue.
  • the second support member 153 has a shaft hole, and the distal end of the rotation shaft 122 rotates with the shaft hole, so that the second support member 153 can provide stable support for the rotation shaft 122 and improve the rotation stability of the rotation shaft 122 .
  • the first support member 152 and the second support member 153 may be plug-fitted to each other, or may be connected by hot melt connection or glue to improve the stability of the connection between them.
  • the first support member 152 and the second support member 153 may be made of PEEK (polyetheretherketone) or other wear-resistant polymers. Using a different material from the rotating shaft 122 can reduce the friction between the first support component 15 and the rotating shaft 122, thereby reducing the vibration of the supporting network 123.
  • PEEK polyetheretherketone
  • the first sealing member 151 is made of silicone material, and the thickness of the first sealing member 151 along the axial direction of the wire passage is 0.1 mm to 1.0 mm. Within this thickness range, the guide wire 10a can easily pass through the first sealing member 151, and when the guidewire 10a is removed from the first sealing member 151, the first sealing member 151 made of silicone material can restore a good sealing effect.
  • the thickness of the first sealing member 151 may specifically be 0.1mm, 0.3mm, 0.4mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1.0mm. It should be noted that the material of the first seal 151 is not limited to silicone.
  • the first seal 151 can also be TPE (Thermoplastic Elastomer) or TPR (Thermo-Plastic-Rubber material). , thermoplastic rubber material).
  • TPE Thermoplastic Elastomer
  • TPR Thermo-Plastic-Rubber material
  • the thickness and material of the first sealing member 151 are not limited here.
  • the second support component 16 may be a sleeve, and the second support component 16 may be fixedly connected to the proximal end of the support network 123 through glue bonding, welding, or hot-melt connection.
  • At least one radial cutout 151a is provided on the side of the first seal 151 facing the rotating shaft 122.
  • the number of the radial cutouts 151a can be three or four. This is not limited.
  • the position of the first sealing member 151 corresponding to the radial cutout 151a is easily pierced by the guide wire 10a. Therefore, this structural arrangement facilitates the operation of inserting the guide wire 10a.
  • the first sealing member 151 will arch toward one side of the catheter 11. In this way, the radial cutout 151a of the first sealing member 151 is The deformation on one side will be more obvious to block the passage of the catheter 11 and prevent the perfusion fluid from flowing out from the distal end of the catheter 11 .
  • the depth of the radial cut 151a is 30% to 70% of the thickness of the first sealing member 151, so that the first sealing member 151 is not only conducive to the penetration of the guidewire 10a, but also can be inserted into the guidewire 10a. Good sealing performance is maintained when wire 10a is removed.
  • the first seal 151 includes at least two stacked silicone pads 1511 .
  • the specific number of silicone pads 1511 may be 2 layers or more than 2 layers, which will not be discussed here. limited.
  • the silicone pads 1511 located at different layers can be provided with incisions and openings to facilitate the guide wire 10a to pass through the first sealing member 151 without adversely affecting the sealing performance of the first sealing member 151.
  • the silicone pad 1511 closest to the catheter 11 is provided with a perforation 151b, and the perforation 151b is configured to allow the guide wire 10a to pass through and to be closed when the guide wire 10a is removed.
  • a perforation 151b is provided on the other side, and the perforation 151b corresponds to the intersection of the radial cutouts 151a, thereby facilitating guidance.
  • the wire 10a passes through the first seal 151.
  • the perforations 151b may be provided on some of the silicone pads 1511, and the other silicone pads 1511 may be provided with radial cuts 151a.
  • the first support component 15 and the second support component 16 can not only be used to support the rotation axis 122 The distal end and the proximal end are supported to improve the rotational stability of the rotating shaft 122.
  • the first supporting component 15 and the second supporting component 16 can be coaxially arranged so that the rotating shaft 122 will not appear during rotation. Radial jitter.
  • the support network 123 is used to pair the first support component 15 and the second support component 16 .
  • the radial restraint of the two supporting components 16 improves the coaxiality of the first supporting component 15 and the second supporting component 16. In this way, during the rotation of the rotating shaft 122, the two ends of the rotating shaft 122 are respectively relative to the first supporting component 15 and the second supporting component 16.
  • the second support component 16 rotates with a stable and consistent axis of rotation, so that no vibration occurs in the radial direction, and the rotation of the rotating shaft 122 is more stable.
  • the coaxiality here refers to the distance between the axes of the first support component 15 and the second support component 16 .
  • the axes of the first support component 15 and the second support component 16 are located on the same axis.
  • the coaxiality of the first support component 15 and the second support component 16 is less than or equal to 0.05 mm.
  • the support network 123 is laser-engraved through a nickel-titanium tube, and the first support component 15 and the second support component 16 are respectively connected to both ends of the support network 123, which can lift the first support component 15 and the support network. 123 and the coaxiality of the second support assembly 16.
  • the proximal end and the distal end of the support net 123 are tapered, thereby facilitating the radial expansion and contraction of the support net 123.
  • the structure of the support net 123 is further described below by taking the support net 123 including a main body 123a and cone portions 123b connected to both ends of the main body 123a as an example.
  • the support net 123 can be in other shapes, as long as the support net 123 covers the peripheral side of the paddle 121 and can expand and contract.
  • the diameter of the cone portion 123b located at the distal end of the support net 123 gradually decreases in the direction approaching the first support component 15 .
  • the diameter of the tapered portion 123b located at the proximal end of the support net 123 gradually decreases in the direction approaching the second support component 16.
  • the tapered portion 123b at the distal end of the support net 123 may also have a diameter that gradually decreases in a direction away from the first support component 15 .
  • the tapered portion 123b of the proximal end of the support net 123 may also have a diameter that gradually decreases in a direction away from the second support component 16 .
  • the medical device 10 includes a transmission shaft 13 , and the distal end of the transmission shaft 13 is connected to the rotation shaft 122 , and the two may be connected by welding or buckling.
  • the transmission shaft 13 can transmit torque to the rotation shaft 122 when rotating, so that the rotation shaft 122 rotates relative to the first support component 15 and the second support component 16 .
  • the medical device 10 includes an inner tube 17 and an outer sheath 18 .
  • the inner tube 17 is sleeved outside the transmission shaft 13 , and the transmission shaft 13 can rotate relative to the inner tube 17 .
  • the distal end of the inner tube 17 is connected to the proximal end of the support network 123.
  • the distal end of the inner tube 17 is connected to the second support component 16. Since the second support component 16 is connected to The proximal end of the support net 123 is connected, so that the distal end of the inner tube 17 is connected to the proximal end of the support net 123 through the second support assembly 16 . That is to say, the second support component 16, the distal end of the inner tube 17 and the proximal end of the support network 123 are connected together.
  • the specific connection method can be welding or glue connection, which will not be described in detail here.
  • the outer sheath 18 is placed outside the inner tube 17 , and the outer sheath 18 is configured to move distally relative to the inner tube 17 to accommodate the foldable pump assembly 12 . It can be understood that when the collapsible pump assembly 12 is received into the outer sheath 18 from the distal end of the outer sheath 18, the collapsible pump assembly 12 will be compressed by the outer sheath 18, thereby maintaining a smaller diameter to accommodate the intervention. Needed in the body. When it is necessary to expand the foldable pump assembly 12, it is only necessary to move the outer sheath tube 18 toward the proximal end relative to the inner tube 17, and move the foldable pump assembly 12 out of the distal end of the outer sheath tube 18. The support network 123 and its The wrapped paddle 121 can then expand radially.
  • a spring tube 19 is set between the drive shaft 13 and the inner tube 17. Specifically, the spring tube 19 is located between the outer wall of the drive shaft 13 and the inner wall of the inner tube 17. The spring tube 19 plays a role in shock absorption. To reduce the vibration when the transmission shaft 13 rotates and improve the rotation stability.
  • the first support component 15 is provided with a protruding structure 15 a extending along its circumferential side, and the surface of the protruding structure 15 a smoothly transitions to the outer wall of the conduit 11 .
  • the outer sheath tube 18 is configured to move relative to the inner tube 17 to offset the protruding structure 15 a, so that the protruding structure 15 a is used to lift the medical device 10 during the interventional operation.
  • the protruding structure 15a may be formed on the first support member 152 or on the second support member 153.
  • the support member 153 is not limited here.
  • the protruding structure 15a is provided with a groove 15b, and the opening of the groove 15b faces the proximal side of the protruding structure 15a.
  • the outer sheath 18 moves toward the inner tube 17 to offset the protruding structure 15 a, the distal end of the outer sheath 18 is received in the groove 15 b, thereby restricting the outer sheath 18 from continuing. Moving toward the distal end, and then causing misoperation due to excessive pushing force, the outer sheath 18 is pushed to the distal end of the first support component 15 , resulting in the risk of scratching the blood vessel wall at the distal end of the outer sheath 18 .
  • the protruding structure 15a may extend for 1/4 of the circumference or 2/3 of the circumference of the first supporting component 15, or may extend for one full circle along the circumferential side of the first supporting component 15.
  • the protruding structure 15a The starting structure 15a is annular.
  • the groove 15b provided on the protruding structure 15a can be an arc-shaped groove or an annular groove, as long as it can meet the receiving needs of the distal end of the outer sheath tube 18.
  • the first sealing member 151 may be disposed at a position corresponding to the protruding structure 15 a of the first support assembly 15 .
  • the position of the first seal 151 corresponds to the position of the protrusion structure 15 a.
  • the position of the structure 15a provides a large enough space to install the first seal 151, which does not increase the overall size of the first support component 15 and at the same time maintains the installation stability and sealing effect of the first seal 151.
  • the medical instrument 10 includes a driving assembly 14 located at the proximal end of the inner tube 17 .
  • the driving assembly 14 is used to drive the transmission shaft 13 to rotate relative to the inner tube 17 .
  • the transmission shaft 13 drives the rotating shaft 122 to rotate, so that the paddle 121 connected to the rotating shaft 122 rotates to promote blood flow.
  • the transmission shaft 13 has a second guide wire cavity 13a connected with the first guide wire cavity 122a, so that the guide wire 10a can penetrate from the first guide wire cavity 122a into the second guide wire cavity 13a, so as to use the guide wire 10a to guide the transmission shaft.
  • the axial movement of 13 further reduces the difficulty of pushing the medical device 10 during its intervention in the body.
  • the driving assembly 14 includes a mounting base 141 , a driven member (not shown) and a driving member (not shown).
  • the mounting base 141 is connected to the proximal end of the inner tube 17, the driven member is rotationally connected to the mounting base 141, the driving member is used to drive the driven member to rotate relative to the mounting base 141, and the driven member is connected to the transmission shaft 13 to drive the
  • the driven piece drives the transmission shaft 13 to rotate, causing the rotation shaft 122 connected to the transmission shaft 13 to rotate, and then the paddle 121 connected to the rotation shaft 122 rotates to promote blood flow.
  • the driving component may specifically include a motor and a driving magnet, and the motor is used to drive the driving magnet to rotate.
  • the driving magnet rotates, the magnetic field environment generated by the driving magnet will also change with it. Therefore, by configuring a structure in the follower that can rotate in the changing magnetic field environment of the driving magnet, the follower can be realized. Drive the transmission shaft 13 to rotate.
  • the driven member includes a driven shaft and a driven magnet.
  • the driven magnet is configured to be magnetically coupled with the driving magnet, so that when the driving magnet rotates, the driven magnet rotates under the action of the magnetic field of the driving magnet.
  • the driven shaft is connected to the driven magnet, and the driven shaft is connected to the transmission shaft 13, so that when the driven shaft rotates, it can drive the transmission shaft 13 to rotate.
  • the driving assembly 14 can be connected as a whole through the housing structure, so that the mounting base 141, the driven member and the driving member meet the corresponding functions of each other.
  • the shell structure can be divided into multiple parts according to actual needs, and the multiple parts can be relatively fixed by threaded connection, glue bonding or snap connection.
  • the driven shaft has a third guidewire lumen
  • the third guidewire lumen is connected to the first guidewire lumen 122a through the second guidewire lumen 13a, whereby the distal catheter 11, the first guidewire The lumen 122a, the second guidewire lumen 13a and the third guidewire lumen can all be passed through by the guidewire 10a.
  • the guidewire 10a can pass through the distal catheter 11, the collapsible pump assembly 12, the drive shaft 13 and the Drive assembly 14, so the guide wire 10a can have a good guiding effect on the structures it passes through, so that during the process of pushing the medical device 10 into the ventricle, these structures can move under the guidance of the guide wire 10a, taking this
  • the implementation further reduces the difficulty of pushing.
  • the driven shaft and the driven magnet can be connected by glue or through the shell.
  • the mounting base 141 is provided with corresponding first bearings and second bearings.
  • the first bearing and the second bearing are both connected to the driven shaft, and are used to improve the smooth rotation of the driven shaft relative to the mounting base 141 . sex.
  • the driven shaft may also be rotationally matched with the shaft hole provided in the mounting base 141.
  • the first bearing and the second bearing Bearings are optional.
  • the mounting base 141 is provided with a lumen, a receiving cavity connected to the lumen, and a perfusion port.
  • Part of the structure of the driven shaft is located in the lumen, and the lumen provides an avoidance position for the rotation of the driven shaft.
  • the perfusion port is used to inject perfusion fluid into the tube cavity, so that the perfusion fluid will flow into the receiving cavity through the tube cavity to cool or lubricate the structural parts in the receiving cavity.
  • the first bearings and the second bearings are respectively disposed on opposite side walls of the receiving cavity. Since the first bearing and the second bearing are both sleeved on the driven shaft, and part of the structure of the driven shaft is located in the lumen, when the perfusion fluid flows from the perfusion port through the lumen into the receiving chamber, the perfusion fluid can align with the lumen and The first bearing at the connection position of the containment cavity has a lubricating effect, and as the perfusion liquid is injected into the containment cavity, the perfusion liquid will eventually come into contact with the second bearing to lubricate the second bearing, and then pass through the first bearing lubricated by the perfusion liquid and The second bearing can further improve the smooth rotation of the driven shaft.
  • the driven member includes a driven shaft and a driven magnet
  • the driven magnet is located in the receiving cavity, and part of the structure of the driven shaft is located in the cavity, so that when the driven member rotates relative to the mounting base 141, it enters
  • the perfusion fluid in the tube cavity can have a good cooling or lubricating effect on the driven shaft.
  • the driven shaft when the driven shaft is rotationally connected to the two opposite side walls of the receiving cavity (for example, the first bearing and the second bearing are rotationally connected to the mounting seat 141), the housing used to install the driven magnet An escape hole is provided for the driven shaft to pass through to meet the installation needs of the driven shaft.
  • the driven shaft is rotationally connected to two opposite side walls of the receiving cavity
  • both sides of the driven shaft corresponding to the driven magnet can be supported by the side walls of the receiving cavity, the driven magnet rotates , the driven shaft can maintain good rotational stability.
  • the rotational connection between the driven shaft and the two opposite side walls of the receiving cavity is not necessary.
  • there is only one rotational connection position between the driven shaft and the mounting base 141 such as omitting one of the first bearing and the second bearing. In this case, the driven shaft can still maintain a rotational connection with the mounting base 141 .
  • the driven shaft may also be connected to the output shaft of the motor so as to rotate relative to the mounting base 141 driven by the output shaft of the motor, which is not limited here.
  • the mounting base 141 is connected with a sealing plug, the sealing plug is used to seal the proximal side of the receiving cavity, the sealing plug has a wire hole, and the sealing plug is configured to guide the guide wire 10a from the wire through hole.
  • the hole penetrates the proximal end of the mounting base 141, and can seal the wire hole when the guide wire 10a is removed, so that the sealing plug can play a good sealing role when the guide wire 10a is removed, preventing the perfusion fluid entering the receiving cavity from The proximal end of the mount 141 leaks.
  • sealing plug For the specific structure of the sealing plug, reference can be made to the first sealing member 151 and will not be described in detail here.
  • the sealing plug is arranged between the interconnected base and the end cover, so that it is not easy to fall off.
  • the base and the end cover can be part of the structure of the mounting base 141 and can be detachably assembled with other structures of the mounting base 141 to facilitate the installation of driven shafts, driven magnets and other structures. Understandably, both the base and the end cap are provided with corresponding through holes for the guide wire 10a to pass through.
  • the mounting seat 141 is provided with a second bearing
  • the base can also be used as a bearing seat.
  • the second bearing is provided on the base to support the proximal end of the driven shaft.
  • the medical device 10 further includes a locking component (not shown) connected to the proximal end of the outer sheath 18 , the locking component is used to lock the relative position of the outer sheath 18 and the inner tube 17 , and is configured to The relative position of the outer sheath 18 and inner tube 17 can be unlocked by operating the locking assembly.
  • a locking component (not shown) connected to the proximal end of the outer sheath 18 , the locking component is used to lock the relative position of the outer sheath 18 and the inner tube 17 , and is configured to The relative position of the outer sheath 18 and inner tube 17 can be unlocked by operating the locking assembly.
  • the outer sheath tube 18 and the inner tube 17 can move axially together without relative movement to each other to avoid incorrect release of the collapsible pump assembly 12 .
  • the locking assembly can be operated to unlock, so that when the outer sheath 18 moves proximally relative to the inner sheath, the foldable pump assembly 12 can move from the distal end of the outer sheath 18 Remove to release collapsible pump assembly 12.
  • the foldable pump assembly 12 includes a flow channel membrane 124 , the distal end of the flow channel membrane 124 is connected to the support network 123 , and the proximal end of the flow channel membrane 124 is connected to the inner tube 17 .
  • the proximal end of the flow channel membrane 124 is provided with a liquid hole 124a.
  • the proximal end of the flow channel membrane 124 is provided with three or more liquid holes 124a, so that the liquid hole 124a can be used as a seal of the collapsible pump assembly 12.
  • the outlet outputs the blood pumped by the paddle 121 of the foldable pump assembly 12 .
  • the inner tube 17 can be moved toward the proximal end relative to the outer sheath 18, so that the flow channel membrane 124 is contracted into the outer sheath 18. In this way, When the foldable pump assembly 12 is inserted into the body, the flow channel membrane 124 will not scratch the percutaneous tissue. After the collapsible pump assembly 12 is inserted into the body, the inner tube 17 can be operated to move distally relative to the outer sheath 18 to remove the flow channel membrane 124 from the distal end of the outer sheath 18.
  • the collapsible pump assembly 12 During operation, blood will be pumped into the flow channel membrane 124, and the pressure of the blood will flush the flow channel membrane 124 open, and will eventually be output from the liquid hole 124a, thereby achieving normal pumping of blood by the foldable pump assembly 12.
  • the support network 123 is provided with a coating 123c, and the coating 123c covers the main body 123a of the support network 123.
  • the flow channel film 124 and the coating 123c are connected by welding or welding.
  • the proximal end of the flow channel membrane 124 is welded or welded to the inner tube 17 so that it can move with the inner tube 17 relative to the outer sheath 18 .
  • the material of the flow channel membrane 124 is a polymer material such as thermoplastic polyurethane elastomer rubber or block polyetheramide resin.
  • the flow channel membrane 124 uses the PEBAX material of the French ATOFINA company.
  • the PEBAX material not only has many unique dynamic mechanical properties between thermoplastics and rubber, but also has excellent antistatic properties.
  • the sealing structure is not limited to the above-mentioned first seal 151, and the sealing structure may also be provided at the distal end of the catheter 11.
  • the medical device 10 includes a sealing structure 20 connected to the distal end of the catheter 11 .
  • the sealing structure 20 can be used to function as the first seal 151 of the previous embodiment.
  • the sealing structure 20 can meet the need for the guide wire 10a to pass through, and at the same time, can also play a good sealing role when the guide wire 10a is removed, so that blood will not enter the first guide wire of the rotating shaft 122 from the catheter 11 The cavity 122a and the perfusion fluid will not be output from the catheter 11 to improve the overall operational convenience and safety of the medical device 10 .
  • the sealing structure 20 includes a connecting member 21, a limiting cover 22, and a second sealing member 23 clamped between the connecting member 21 and the limiting cover 22.
  • the connecting member 21 is connected to the distal end of the catheter 11, and the connecting member 21 is connected to the distal end of the catheter 11.
  • 21 has a first guide wire hole 21a connected with the conduit 11
  • the limiting cover 22 has a second guide wire hole 22a corresponding to the first guide wire hole 21a
  • the second sealing member 23 has a center for the guide wire 10a to pass through.
  • hole 23a, and the second sealing member 23 is configured to be squeezed so that the central hole 23a is in a closed state.
  • connection between the connecting piece 21 and the conduit 11 and between the connecting piece 21 and the limiting cover 22 can be connected by glue, hot melt connection or threaded connection, which are not limited here.
  • the second sealing member 23 is made of elastic polymer material.
  • the second sealing member 23 is made of silicone or rubber, so that the second sealing member 23 has certain compression, deformation and recovery capabilities.
  • the second seal 23 is in its original state before assembly. Its shape is generally a cylinder with a central hole 23a.
  • the outer diameter should be similar or equal to the inner diameter of the limiting cover 22 to ensure that it can be installed. into the inner cavity of the limiting cover 22.
  • the central hole 23a of the second sealing member 23 has a certain inclination angle and is in the shape of two upper and lower funnels. That is, the diameter of the central hole 23a gradually increases in the direction away from the middle part of the second sealing member 23. As shown in FIG.
  • the upper and lower end surfaces of the second sealing member 23 still have a funnel-shaped structure at positions corresponding to the central hole 23a, which will facilitate the passage of the guide wire 10a.
  • the guide wire 10a passes through, since the second sealing member 23 has a certain compression capability, the hole wall of the central hole 23a of the second sealing member 23 is in sealing contact with the guide wire 10a, and allows the guide wire 10a to pass smoothly.
  • the guide wire 10a is withdrawn, and the second sealing member 23 returns to the state of closing the central hole 23a to ensure the sealing performance during the operation.
  • a doctor performs a femoral artery puncture operation and inserts the guidewire 10a into the body from the femoral artery. After passing through the aorta and aortic arch, the head end of the guidewire 10a crosses the valve and enters the ventricle, and the end of the guidewire 10a is located outside the body. Then the percutaneous interventional surgery begins. First, the outer sheath 18 is moved distally relative to the inner tube 17, and the foldable pump assembly 12 is compressed and folded into the outer sheath 18 to reach the intervention size and meet the intervention needs.
  • the guide wire 10a is inserted from the distal end of the catheter 11, and the medical device 10 is continued to be pushed, so that the guide wire 10a enters the first guide wire lumen 122a through the catheter 11.
  • the guide wire 10 a will first pass through the first support component 15 before entering the first guide wire lumen 122 a through the catheter 11 of the first sealing member 151, and then enters the first guidewire cavity 122a.
  • the guide wire 10a After the guide wire 10a passes through the first guide wire cavity 122a, it enters the second guide wire cavity 13a of the transmission shaft 13, and enters the third guide wire cavity of the driven shaft along the second guide wire cavity 13a. In this way, when the medical instrument 10 is moved distally along the guidewire 10a to perform an interventional operation, the guidewire 10a passes through structures such as the catheter 11, the collapsible pump assembly 12, the drive shaft 13 and the driven shaft to guide these structures. The structure enters the body smoothly.
  • the mounting seat 141 continues to move toward the distal end along the guide wire 10a, so that The guide wire 10a passes through the wire hole and passes out from the proximal end of the mounting base 141.
  • the proximal end of the mounting base 141 may be provided with a hole corresponding to the wire hole, so that the guide wire 10a can pass through the proximal end of the mounting base 141 . After the end of the guide wire 10a passes through the proximal end of the mounting base 141, it is equivalent to the guide wire 10a passing through the entire medical device 10.
  • the medical device 10 can be moved distally along the guide wire 10a, and the medical device 10 intervention in the human body. Since the guide wire 10a passes through the catheter 11 at the distal end of the medical device 10 and exits from the proximal end of the mounting base 141, during the intervention process, the medical device 10 will successfully complete the crossing of the aortic arch along the path guided by the guide wire 10a in the body. and transvalvular procedures.
  • the guide wire 10a is withdrawn from the proximal end of the mounting base 141 to complete the entire interventional surgery.
  • the perfusion fluid such as physiological saline
  • the perfusion fluid such as physiological saline
  • part of the perfusion fluid flows into the receiving cavity to lubricate and cool the driven shaft; the other part will pass through
  • the inner tube 17, the transmission shaft 13, the spring tube 19 and other pipe fittings flow to the foldable pump assembly 12 to lubricate the rotating shaft 122, thereby reducing the friction of the rotating shaft 122 or the transmission shaft 13 and other structures during the pumping process of the foldable pump assembly 12. temperature.
  • the first seal 151 and the sealing plug can both pass through the guide wire 10a and can play a sealing role when the guide wire 10a is removed, when the perfusion fluid is injected into the lumen of the mounting base 141 through the perfusion port At this time, under the action of the first seal 151 , the perfusion fluid flowing to the collapsible pump assembly 12 will not enter the body through the conduit 11 , and accordingly, the blood will not enter the collapsible pump assembly 12 from the conduit 11 . Under the action of the sealing plug, the perfusion fluid flowing into the receiving cavity will not leak out from the proximal end of the mounting base 141.
  • the perfusion volume of the perfusion solution can be effectively reduced while the extracorporeal perfusion pressure remains unchanged, so as to achieve the purpose of reducing the patient's cardiac load, thereby reducing the risk of surgery. .
  • the perfusion fluid includes but is not limited to physiological saline.
  • the perfusion fluid can also be other lubricating fluids used for lubrication or cooling fluids used for cooling.
  • first and second are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. . Therefore, features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise expressly and specifically limited.
  • connection can be a fixed connection or a detachable connection.
  • Connection, or integration can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary; it can be an internal connection between two elements or an interaction between two elements, unless There are clear limitations. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.
  • a first feature being "on” or “below” a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediary. touch.

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  • Heart & Thoracic Surgery (AREA)
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Abstract

一种医疗器械，包括导管(11)、可折叠泵组件(12)和密封结构(20)，可折叠泵组件(12)与导管(11)的近端相连接，可折叠泵组件(12)包括支撑网(123)、桨叶(121)以及用于带动桨叶(121)转动的旋转轴(122)，支撑网(123)被配置为包覆于桨叶(121)的周侧且能够径向扩张和收缩，旋转轴(122)具有第一导丝腔(122a)，第一导丝腔(122a)被配置为能够供导丝(10a)穿过，且第一导丝腔(122a)能够从远端输出灌注液，密封结构(20)与导管(11)相连接，密封结构(20)被配置为能够供导丝(10a)穿过且当导丝(10a)移除时能够密封导管(11)。

Description

医疗器械 技术领域
本申请涉及医疗器械技术领域，特别是涉及一种医疗器械。
背景技术
血泵作为一种医疗器械，主要用于心源性休克的急救和高危PCI(percutaneous coronary intervention，经皮冠状动脉介入治疗)手术期间的辅助循环。置于主动脉瓣膜上的血泵，可以提供高达4L/min的流量支持，从而代替心脏的泵血功能，可以挽救心源性休克患者的生命，或者在高危PCI患者的手术期间，稳定心脏状态，减少心律失常的发生，从而降低手术风险，保证高危PCI手术的成功率。
血泵可以为经皮介入式血泵，其介入方式为通过股动脉穿刺手术，具体地，首先将导丝经由股动脉插入体内，通过主动脉和主动脉弓到达瓣膜位置后，导丝跨瓣膜进入心室内，随后将导丝位于体外的部分插入血泵远端，使得血泵可以在导丝的引导下进入体内，并最终抵达心室内。此外，该类型血泵的可折叠泵组件由具有可收缩性的材料制成，通过外鞘管进入心脏，到达位置后从外鞘管移出时，可折叠泵组件展开并固定在主动脉瓣膜上，实现泵血功能。
然而，相关技术的血泵进行介入操作过程中，需要利用导丝进行引导，否则将导致推送困难，甚至无法顺利推送，此外，血泵工作时需要注入灌注液进行冷却或润滑，这就需要在血泵中设置灌注通道，在血泵同时设置供导丝穿过的导丝通道和用于输送灌注液的灌注通道，会导致血泵结构复杂，各部分结构直径大，进一步增加推送难度，不利于血泵进入体内，而将灌注通道用来供导丝穿过，又会面临灌注液泄露至心脏，增加心脏负担的问题。
发明内容
基于此，有必要提供一种医疗器械。
本申请提供一种医疗器械，包括：
导管；
可折叠泵组件，与所述导管的近端相连接，所述可折叠泵组件包括支撑网、桨叶以及用于带动所述桨叶转动的旋转轴，所述支撑网被配置为包覆于所述桨叶的周侧且能够径向扩张和收缩，所述旋转轴具有与所述导管相连通的第一导丝腔所述第一导丝腔被配置为能够供导丝穿过，且所述第一导丝腔能够从远端输出灌注液；及
密封结构，与所述导管相连接，所述密封结构被配置为能够供所述导丝穿过且当所述导丝移除时能够密封所述导管。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他实施例的附图。
图1为本申请一实施方式的血泵的结构示意图；
图2为一实施方式的血泵的局部结构剖面示意图；
图3为图2中的A部分结构的局部放大示意图；
图4为图2中的B部分结构的局部放大示意图；
图5为一实施方式的血泵中的第一密封件的结构示意图；
图6为另一实施方式的血泵中的第一密封件的结构示意图；
图7为图6示出的血泵中的第一密封件的另一视角的结构示意图；
图8为一实施方式的血泵中，可折叠泵组件与导管的连接示意图；
图9为一实施方式的血泵中，外鞘管、内管及传动轴的局部结构剖视图；
图10为一实施方式的血泵的可折叠泵组件位于外鞘管外时的结构示意图；
图11为图10示出的血泵的可折叠泵组件收容至外鞘管内时的结构示意图；
图12为一实施方式的血泵的第二支撑件的结构示意图；
图13为一实施方式的血泵的第二支撑件的剖面结构示意图；
图14为另一实施方式的血泵的可折叠泵组件收容至外鞘管外的结构示意图；
图15为一实施方式的血泵的可折叠泵组件收容至外鞘管内时的剖面结构示意图；
图16为一实施方式的血泵的导管的剖面结构示意图；
图17为图16示出的血泵的导管的远端的密封结构组装前的结构示意图；
图18为图17示出的血泵的导管的远端的密封结构组装后的结构示意图；
图19为导丝穿过导管的远端及密封结构时的结构示意图。
附图标记：
10、血泵；10a、导丝；11、导管；12、可折叠泵组件；121、桨叶；122、旋转轴；122a、第一导丝腔；123、支撑网；123a、主体部；123b、锥部；123c、覆膜；124、流道膜；124a、过液孔；13、传动轴；13a、第二导丝腔；14、驱动组件；141、安装座；15、第一支撑组件；15a、凸起结构；15b、凹槽；151、第一密封件；151a、径向切口；151b、穿孔；1511、硅胶垫；152、第一支撑件；152a、第一通孔；153、第二支撑件；153a、第二通孔；16、第二支撑组件；17、内管；18、外鞘管；19、弹簧管；20、密封结构；21、连接件；21a、第一导丝孔；22、限位盖；22a、第二导丝孔；23、第二密封件；23a、中心孔。
具体实施方式
为了便于理解本申请，下面将参照相关附图对本申请进行更全面的描述。附图中给出了本申请的首选实施例。但是，本申请可以以许多不同的形式来实现，并不限于本文所描述的实施例。相反地，提供这些实施例的目的是使对本申请的公开内容更加透彻全面。
需要说明的是，采用“远端”、“近端”作为方位词，该方位词为介入医疗器械领域惯用术语，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。轴向，指平行于医疗器械远端中心和近端中心连线的方向；径向，指垂直于上述轴向的方向。
参阅图1和图2所示，本申请提供的一种医疗器械10，能够采取经皮介入的方式进入体内，用于心源性休克的急救和高危PCI手术期间的辅助循环。
医疗器械10包括导管11、可折叠泵组件12和密封结构。
导管11的远端可以为猪尾形端部或J形端部，由于这类导管11的端部像猪的尾巴一样弯曲，通常将此类导管11称为“猪尾巴管”或“J型导管”。导管11的近端与可折叠泵组件12相连接，在可折叠泵组件12介入至体内和固定可折叠泵组件12时，导管11可以起到避免损伤血管及心室壁的作用。而且，导管11可以供导丝10a穿过，从而利用导丝10a进行引导，以方便进行经皮介入操作。
可折叠泵组件12包括桨叶121以及用于带动桨叶121转动的旋转轴122，旋转轴122具有与导管11相连通的第一导丝腔122a，从而导丝10a可以经导管11穿入第一导丝腔122a。第一导丝腔122a能够从远端输出灌注液，以对旋转轴122进行冷却或润滑。
该实施方式中，可折叠泵组件12包括支撑网123，支撑网123被配置为包覆于桨叶121的周侧且能够径向扩张和收缩。支撑网123在扩张状态下，能够对血管壁进行支撑并限定出桨叶121的旋转空间，避免桨叶121转动过程中刮伤血管组织。相应地，支撑网123作为可折叠泵组件12的一部分，能够适应折叠需要，以便在医疗器械10介入体内的过程中，维持小的输送直径，以利于减小创口。
支撑网123具体可以是镍钛合金或钴铬合金等记忆合金材料制成，在此不做限定。
密封结构与导管11相连接，密封结构被配置为能够供导丝10a穿过且当导丝10a移除时能够密封导管11。由此，密封结构不会妨碍导丝10a从导管11进入旋转轴122的第一导丝腔122a，使得导丝 10a能够对导管11和可折叠泵组件12发挥良好引导效果，同时，在医疗器械10进入体内进行工作时，即使将导丝10a从密封结构移除，密封结构可以维持对导管11的密封性，从而第一导丝腔122a远端输出灌注液对旋转轴122进行冷却或润滑的过程中，灌注液不会从导管11进入体内而造成患者心脏负荷增加，因此，采取这种医疗器械10，可以有效降低手术风险。可理解地，由于密封结构可以在导丝10a移除时维持对导管11的密封性，从而，医疗器械10工作过程中，血液也不会从导管11进入第一导丝腔122a。
在一些实施方式中，导管11为高分子软管，材料可以是热塑性聚氨酯弹性体橡胶或嵌段聚醚酰胺树脂等高分子材料，以减少对经皮组织的损伤。
需要说明的是，密封结构可以是直接与导管11相连接，也可以是通过其他结构件与导管11间接相连接，只要密封结构能够满足导丝10a穿过的需要，且在导丝10d移除时能够对导管11进行密封即可。这里的对导管11进行密封包括但不限于在导管11的远端或者在导管11的近端进行密封。
为了便于理解，下面结合医疗器械10的结构示例性地对密封结构的设置位置及结构做进一步说明。
在一些实施方式中，密封结构设置在导管11的近端，具体地，密封结构设置在导管11与旋转轴122之间。
进一步地，结合图2所示，医疗器械10包括第一支撑组件15和第二支撑组件16，第一支撑组件15与支撑网123的远端固定连接，第二支撑组件16与支撑网123的近端固定连接，第一支撑组件15和第二支撑组件16被配置为能够共同支撑旋转轴122且允许旋转轴122旋转运动。确切的说，第一支撑组件15和第二支撑组件16分别转动连接于旋转轴122的远端和近端，从而实现对旋转轴122进行稳定支撑，并满足旋转轴122转动需要，以提升旋转轴122的转动稳定性。
第一支撑组件15至少部分设置于旋转轴122与导管11之间，第一支撑组件15与导管11之间可以通过胶水粘接、焊接或热熔连接等方式相连。支撑网123的远端可以是通过胶水粘接、焊接或热熔连接等方式连接于第一支撑组件15。结合图3所示，第一支撑组件15具有用于连通导管11与第一导丝腔122a的过丝通道，密封结构包括设置于过丝通道的第一密封件151，第一密封件151被配置为能够供导丝10a穿过过丝通道且当导丝10a移除时能够密封过丝通道。通过这种结构设置，一方面，第一密封件151能够适应导丝10a从导管11进入第一导丝腔122a的需要，实现导丝10a穿过旋转轴122，以提升对可折叠泵组件122的引导效果，降低介入手术难度；另一方面，在导丝10a移出后，导管11与第一导丝腔122a之间具有良好的密封性，使得医疗器械10使用时，血液不会从导管11进入第一导丝腔122a，且进入第一导丝腔122a的灌注液不会从导管11进入体内，以防止灌注量过大导致增加患者心脏负荷，因此，采取这种结构设置有效地降低了手术风险。
在一些实施例中，第一支撑组件15包括相互连接的第一支撑件152和第二支撑件153，第一支撑件152与导管11相连接，且第一支撑件152具有第一通孔152a，以与导管11相连通。第二支撑件153与旋转轴122相连，且第二支撑件153具有第二通孔153a，第二通孔153a与第一导丝腔122a相连通。因此，第一通孔152a和第二通孔153a互不连通时，导管11则与第一导丝腔122a互不连通，继而液体将无法在两者之间流动。采用上下分体式的第一支撑组件15方便安装第一密封结构同时保持第一支撑组件15与旋转轴122的同轴性。
需要说明的是，第一支撑组件15也可以为一体成型的结构，可理解为第一支撑件152和第二支撑件153一体成型，即第一支撑组件15的远端连接导管11，第一支撑组件15的近端连接旋转轴122，第一密封件151优选高弹性材料，通过过丝通道进入第一支撑组件15后自动弹开以嵌设于第一支撑组件15。
第一通孔152a和第二通孔153a的直径可以为0.2mm～1.0mm，在此不做限定，只要能够满足导丝10a穿过需要即可。相应地，前述的第一导丝腔122a、第二导丝腔13a和第三导丝腔的孔径，只要能够满足导丝10a穿过需要即可，具体孔径大小在此不做限定。
第一支撑件152和第二支撑件153之间形成安装腔，第一通孔152a和第二通孔153a均与安装腔相连通，三者共同形成过丝通道。第一密封件151设置于安装腔内，该实施方式中，利用第一支撑件152和第二支撑件153提高第一密封件151的安装稳定性以及便利性。
需要说明的是，第一密封件151在第一通孔152a和第二通孔153a之间起到密封效果，使得液体无法在导管11和第一导丝腔122a之间流动，确切的说，在医疗器械10使用时，体内的血液无法从导管11进入第一导丝腔122a，流入第一导丝腔122a的灌注液无法进入导管11。
利用第一支撑件152和第二支撑件153可以方便地与导管11和旋转轴122相连接。具体地，第一支撑件152可以与导管11的近端插接配合，并通过胶水提高两者之间的连接稳定性。第二支撑件153具有轴孔，旋转轴122的远端与轴孔转动配合，以便利用第二支撑件153为旋转轴122提供稳定地支撑，提升旋转轴122的转动稳定性。
第一支撑件152和第二支撑件153彼此之间可以采取插接配合，也可以采取热熔连接或胶水连接来提升彼此间的连接稳定性。
第一支撑件152和第二支撑件153可以是PEEK(polyetheretherketone，聚醚醚酮)或其他耐磨高分子制成。采用与旋转轴122不同材料，可减少第一支撑组件15与旋转轴122之间的摩擦，从而减少支撑网123的震动。
在一些实施方式中，第一密封件151为硅胶材质，且第一密封件151沿过丝通道的轴向上的厚度为0.1mm至1.0mm。该厚度的取值范围内，导丝10a容易穿过第一密封件151，且在导丝10a从第一密封件151移除时，硅胶材质的第一密封件151能够恢复良好的密封效果。第一密封件151的厚度具体可以为0.1mm、0.3mm、0.4mm、0.6mm、0.7mm、0.8mm、0.9mm或1.0mm。需要说明的是，第一密封件151的材质不限于硅胶，例如，在一些实施方式中，第一密封件151还可以是TPE(Thermoplastic Elastomer，热塑性弹性体)或TPR(Thermo-Plastic-Rubber material，热塑性橡胶材料)。对于第一密封件151的厚度及材质，在此不做限定。
结合图2和图4所示，第二支撑组件16具体可以为套筒，第二支撑组件16可以通过胶水粘接、焊接或热熔连接等方式与支撑网123的近端固定连接。
结合图5和图6所示，第一密封件151的朝向旋转轴122的一侧设有至少一个径向切口151a，径向切口151a的数量具体可以为3个，也可以为4个，在此不做限定。第一密封件151对应径向切口151a处容易被导丝10a刺穿，因此，通过这种结构设置，有利于穿导丝10a的操作。此外，在医疗器械10运行阶段，受到从旋转轴122中流出的灌注液的冲击，第一密封件151会向导管11的一侧拱起，这样，第一密封件151的设置径向切口151a的一侧的形变会更加明显，以堵住导管11的通路，防止灌注液从导管11的远端流出。
沿过丝通道的轴向上，径向切口151a的深度为第一密封件151的厚度的30％至70％，从而使得第一密封件151既有利于导丝10a刺穿，同时能够在导丝10a移除时维持良好的密封性能。
需要说明的是，结合图6所示，第一密封件151包括至少2个层叠设置的硅胶垫1511，具体硅胶垫1511的层数可以是2层，也可以是大于2层，在此不做限定。通过这种设置，可以对位于不同层的硅胶垫1511进行切口和开孔设置，以利于导丝10a穿过第一密封件151，又不至于对第一密封件151的密封性能造成不良影响。例如，结合图7所示，距离导管11最近的硅胶垫1511设置有穿孔151b，穿孔151b被配置为能够供导丝10a穿过且当导丝10a移除时能够闭合。
在一些实施方式中，第一密封件151的朝向旋转轴122的一侧设置径向切口151a的同时，另一侧设置穿孔151b，穿孔151b对应于径向切口151a的交汇处，从而有利于导丝10a穿过第一密封件151。需要说明的是，在第一密封件151包括2层或2层以上的硅胶垫1511时，穿孔151b可以是设置在其中的一些硅胶垫1511上，另一些硅胶垫1511设置径向切口151a。
结合图2和图8所示，在医疗器械10包括第一支撑组件15和第二支撑组件16的实施方式中，第一支撑组件15和第二支撑组件16不仅可以用于对旋转轴122的远端和近端进行支撑，提升旋转轴122的转动稳定性，同时，第一支撑组件15和第二支撑组件16可以通过同轴设置的方式，来使得旋转轴122在转动过程中不会出现径向抖动。
结合图8所示，由于支撑网123的远端与第一支撑组件15相连接，支撑网123的近端与第二支撑组件16相连接，从而利用支撑网123对第一支撑组件15和第二支撑组件16的径向约束，提升第一支撑组件15和第二支撑组件16的同轴度，这样，旋转轴122在转动过程中，旋转轴122的两端分别相 对第一支撑组件15和第二支撑组件16转动，具有稳定一致的转动轴线，继而不会在径向上出现抖动，旋转轴122的转动更稳定。这种结构设置下，由于旋转轴122在径向上的抖动减小，从而旋转轴122带动桨叶121转动时，桨叶121与支撑网123之间出现刮擦的几率降低，进而有效减少因桨叶121与支撑网123的刮擦而损伤血细胞及溶血现象的出现几率。
需要说明的是，这里的同轴度指的第一支撑组件15和第二支撑组件16的轴心的距离。第一支撑组件15和第二支撑组件16之间为理想的同轴设置时，第一支撑组件15和第二支撑组件16的轴心位于同一轴线上。在一些实施方式中，第一支撑组件15和第二支撑组件16的同轴度小于或等于0.05mm。在一些实施方式中，支撑网123通过一根镍钛管进行激光雕刻，且第一支撑组件15、第二支撑组件16分别连接支撑网123的两端，可提升第一支撑组件15、支撑网123和第二支撑组件16的同轴度。
支撑网123的近端和远端呈锥状，从而方便支撑网123径向扩张和收缩。
为方便理解，下面以支撑网123包括主体部123a以及连接于主体部123a两端的锥部123b为例对支撑网123的结构做进一步说明，但并非限定支撑网123的端部只能是锥状，可理解地，支撑网123可以是其他形状，只要支撑网123包覆于桨叶121的周侧且能够扩张和收缩即可。
结合图8所示，位于支撑网123的远端的锥部123b在靠近第一支撑组件15的方向上，直径逐渐减小。位于支撑网123的近端的锥部123b在靠近第二支撑组件16的方向上，直径逐渐减小。
在一些实施方式中，支撑网123的远端的锥部123b也可以是在远离第一支撑组件15的方向上，直径逐渐减小。相应地，支撑网123的近端的锥部123b也可以是在远离第二支撑组件16的方向上，直径逐渐减小。
结合图2所示，医疗器械10包括传动轴13，传动轴13的远端与旋转轴122相连接，两者之间具体可以是通过焊接或卡扣连接。该实施方式中，传动轴13能够在转动时向旋转轴122传递扭矩，以使得旋转轴122相对第一支撑组件15和第二支撑组件16转动。
结合图9所示，医疗器械10包括内管17和外鞘管18，内管17套设于传动轴13外，传动轴13能够相对内管17转动。如图1和图4所示，内管17的远端与支撑网123的近端相连接，具体地，内管17的远端与第二支撑组件16相连接，由于第二支撑组件16与支撑网123的近端相连接，从而内管17的远端通过第二支撑组件16与支撑网123的近端相连接。也就是说，第二支撑组件16、内管17的远端和支撑网123的近端三者连接在一起。具体连接方式可以为焊接或胶水连接，在此不做赘述。
外鞘管18套设于内管17外，外鞘管18被配置为能够相对内管17朝远端移动以收容可折叠泵组件12。可理解地，在可折叠泵组件12从外鞘管18的远端收容至外鞘管18内时，可折叠泵组件12将被外鞘管18压缩，从而维持较小的直径，以适应介入体内需要。在需要将可折叠泵组件12展开时，则只需将外鞘管18相对内管17朝近端移动，将可折叠泵组件12从外鞘管18的远端移出，支撑网123及其所包裹的桨叶121便可以径向扩张。
进一步地，传动轴13与内管17之间套设有弹簧管19，具体地，弹簧管19位于传动轴13的外壁与内管17的内壁之间，弹簧管19起到减震的作用，以降低传动轴13转动时的振动，提高转动稳定性。
结合图10所示，在一些实施方式中，第一支撑组件15设置有延其周侧延伸的凸起结构15a，凸起结构15a的表面与导管11的外壁平滑过渡。结合图11所示，外鞘管18被配置为能够相对内管17移动至与凸起结构15a相抵，从而利用凸起结构15a提升医疗器械10介入操作过程中，导管11、第一支撑组件15和外鞘管18的表面的平滑性，避免外鞘管18的远端划伤主动脉血管。需要说明的是，在第一支撑组件15包括第一支撑件152和第二支撑件153的实施方式中，该凸起结构15a可以是形成于第一支撑件152，也可以是形成于第二支撑件153，在此不做限定。
进一步地，结合图12和图13所示，凸起结构15a开设有凹槽15b，凹槽15b的开口朝向凸起结构15a的近端侧。结合图14和图15所示，当外鞘管18相对内管17朝移动至与凸起结构15a相抵时，外鞘管18的远端收容于凹槽15b内，从而限制外鞘管18继续朝远端移动，继而因推力过大导致误操作，外鞘管18推到第一支撑组件15的远端而导致外鞘管18的远端存在刮伤血管壁的风险。
需要说明的是，凸起结构15a可以是沿第一支撑组件15的周侧延伸1/4圆周或2/3圆周，还可以是沿第一支撑组件15的周侧延伸一周，此时，凸起结构15a呈环形。相应地，设置于凸起结构15a的 凹槽15b可以是弧形槽，也可以是环形槽，只要能够适应外鞘管18的远端的收容需要即可。
在密封结构包括第一密封件151的实施方式中，可以将第一密封件151设置在第一支撑组件15的对应凸起结构15a的位置。结合图15所示，在第一支撑组件15的轴向上，第一密封件151的位置和凸起结构15a的位置相对应，通过这种结构设置，可以利用第一支撑组件15的对应凸起结构15a的位置提供足够大的空间设置第一密封件151，这样既不会增大第一支撑组件15的外形尺寸，同时，又能够维持第一密封件151的安装稳定性及密封效果。
再次参阅图1所示，医疗器械10包括位于内管17近端的驱动组件14，该驱动组件14用于驱使传动轴13相对内管17转动。驱动组件14驱使传动轴13相对内管17转动时，传动轴13带动旋转轴122转动，从而连接于旋转轴122的桨叶121的转动以推动血液流动。
传动轴13具有与第一导丝腔122a相连通的第二导丝腔13a，这样导丝10a可以从第一导丝腔122a穿入第二导丝腔13a，以便利用导丝10a引导传动轴13轴向移动，进一步降低了医疗器械10介入体内过程中的推送难度。
再次参阅图1所示，驱动组件14包括安装座141、从动件(图未示出)和驱动件(图未示出)。安装座141与内管17的近端相连接，从动件与安装座141转动连接，驱动件用于带动从动件相对安装座141转动，从动件与传动轴13相连接，以在驱动件工作时，从动件带动传动轴13转动，使得与传动轴13相连接的旋转轴122转动，继而连接于旋转轴122的桨叶121的转动以推动血液流动。
驱动件具体可以包括电机和驱动磁钢，电机用于驱使驱动磁钢转动。驱动磁钢转动时，驱动磁钢所产生的磁场环境也将随着一起变化，由此，在从动件中配置能够在驱动磁钢的变化磁场环境下转动的结构，就能够实现从动件带动传动轴13转动。
从动件包括从动轴和从动磁钢，从动磁钢被配置为能够与驱动磁钢磁耦合，以在驱动磁钢转动时，从动磁钢在驱动磁钢的磁场作用下转动。该实施方式中，从动轴与从动磁钢相连接，从动轴与传动轴13相连接，从而从动轴转动时能够带动传动轴13转动。
需要说明的是，驱动组件14可以是通过外壳结构连接为一个整体，使得安装座141、从动件和驱动件彼此满足相应的功能。外壳结构可以根据实际需要分成多个部分，多个部分之间可以采取螺纹连接、胶水粘接或卡扣连接实现相对固定。
在一些实施方式中，从动轴具有第三导丝腔，第三导丝腔经第二导丝腔13a与第一导丝腔122a相连通，由此，远端导管11、第一导丝腔122a、第二导丝腔13a和第三导丝腔均能够供导丝10a穿过，确切的说，导丝10a能够依次穿过远端导管11、可折叠泵组件12、传动轴13和驱动组件14，因此导丝10a对其穿过的这些结构可以起到良好的引导效果，从而在推送医疗器械10进入心室的过程中，这些结构均可以在导丝10a的引导下移动，采取该实施方式进一步降低了推送难度。
从动轴与从动磁钢具体可以采取胶水连接，也可以通过壳体相连接。
在一些实施方式中，安装座141内设置有相对应的第一轴承和第二轴承，第一轴承和第二轴承均与从动轴相连，并用于提升从动轴相对安装座141转动的顺畅性。可以理解的是，在一些实施方式中，从动轴也可以是与设置于安装座141的轴孔转动配合，对实现从动轴与安装座141的转动连接而言，第一轴承和第二轴承是非必要的。
在一些实施方式中，安装座141设有管腔、与管腔相连通的收容腔以及灌注口，从动轴的部分结构位于管腔内，管腔为从动轴的转动提供了避空位。灌注口用于向管腔注入灌注液，从而灌注液会经管腔流入收容腔，以对收容腔内的结构件进行冷却或润滑。
以注入的灌注液为润滑液为例，在安装座141内设置有相对应的第一轴承和第二轴承的实施方式中，第一轴承和第二轴承分别设置于收容腔的相对侧壁，由于第一轴承和第二轴承均套设于从动轴，而从动轴的部分结构位于管腔内，从而灌注液从灌注口经管腔流入收容腔时，灌注液能够对位于管腔和收容腔连接位置的第一轴承起到润滑效果，并且随着灌注液注入收容腔，灌注液最终会与第二轴承接触，以对第二轴承进行润滑，继而经过灌注液润滑的第一轴承和第二轴承能够进一步提升从动轴的转动顺畅性。
在从动件包括从动轴和从动磁钢实施方式中，从动磁钢位于收容腔内，从动轴的部分结构位于管 腔内，从而在从动件相对安装座141转动时，进入管腔的灌注液可以对从动轴起到良好的降温或润滑效果。
可理解地，在从动轴与收容腔的两个相对的侧壁转动连接(例如通过第一轴承和第二轴承与安装座141转动连接)时，用于安装从动磁钢的壳体上开设有供从动轴穿过的避空孔，以适应从动轴的安装需要。
从动轴与收容腔的两个相对的侧壁转动连接的实施方式中，由于从动轴的对应从动磁钢的两侧均能够得到收容腔的侧壁的支撑，从而从动磁钢转动时，从动轴能够保持良好的转动稳定性。需要说明的是，从动轴与收容腔的两个相对的侧壁转动连接并非必要的。在一些实施方式中，从动轴与安装座141之间只有一个转动连接位置，比如省略第一轴承和第二轴承中的一个，此时，从动轴仍可以保持与安装座141转动连接。
需要说明的是，从动轴也可以是与电机的输出轴相连接，从而在电机的输出轴的驱使下相对安装座141转动，在此不做限定。
在一些实施方式中，安装座141连接有密封堵头，密封堵头用于密封收容腔的近端侧，密封堵头具有过丝孔且密封堵头被配置为能够引导导丝10a从过丝孔穿出安装座141的近端，且当导丝10a移除时能够密封过丝孔，从而密封堵头可以在导丝10a移除时起到良好密封作用，避免进入收容腔的灌注液从安装座141的近端漏出。
密封堵头的具体结构可以参考第一密封件151，在此不做赘述。
进一步地，密封堵头设置在相互连接的基座和端盖之间，从而不容易脱落。基座和端盖可以作为安装座141的结构的一部分，可以采取可拆卸地方式与安装座141的其他结构组装在一起，从而方便安装从动轴、从动磁钢等结构。可理解地，基座和端盖均设有相应的通孔，以便供导丝10a穿过。在安装座141设置有第二轴承的实施方式中，基座还可以作为轴承座使用，确切的说，第二轴承设置于基座，以对从动轴的近端进行支撑。
在一些实施方式中，医疗器械10还包括与外鞘管18的近端相连接的锁定组件(图未示出)，锁定组件用于锁定外鞘管18与内管17的相对位置，并且通过操作锁定组件可以解除对外鞘管18和内管17的相对位置的锁定。通过这种结构设置，在将可折叠泵组件12从外鞘管18的远端收入至外鞘管18内后，可以利用锁定组件锁定外鞘管18和内管17的相对位置，使得介入操作过程中，外鞘管18和内管17能够一起轴向移动而彼此间不会相对运动，以避免错误释放可折叠泵组件12。待可折叠泵组件12介入至体内合适位置后，则可以操作锁定组件解除锁定，以便外鞘管18相对内鞘管朝近端移动时，可折叠泵组件12能够从外鞘管18的远端移出，以释放可折叠泵组件12。
再次参阅图1和图2所示，可折叠泵组件12包括流道膜124，流道膜124的远端与支撑网123相连接，流道膜124的近端与内管17相连接。流道膜124的近端设置有过液孔124a，例如，流道膜124的近端开有3个或3个以上的过液孔124a，以利用过液孔124a作为可折叠泵组件12的出口，输出可折叠泵组件12的桨叶121所泵出的血液。
由于流道膜124的近端与内管17相连接，从而可以通过将内管17相对外鞘管18朝近端移动，以使得流道膜124被收缩至外鞘管18内，这样在将可折叠泵组件12介入体内的过程中，流道膜124不会刮伤经皮组织。在将可折叠泵组件12介入体内后，可以操作内管17相对外鞘管18朝远端移动，以将流道膜124从外鞘管18的远端移出，此时，可折叠泵组件12运行过程中会向流道膜124内泵血，血液的压力会将流道膜124冲开，并最终从过液孔124a输出，从而实现可折叠泵组件12的正常泵血。
在一些实施方式中，支撑网123上设有覆膜123c，覆膜123c包覆于支撑网123的主体部123a，流道膜124与覆膜123c通过熔接或者焊接的方式连接。流道膜124的近端与内管17熔接或者焊接在一起，从而能够随内管17相对外鞘管18移动。
在一些实施方式中，流道膜124的材料为热塑性聚氨酯弹性体橡胶或嵌段聚醚酰胺树脂等高分子材料。例如，流道膜124采用法国ATOFINA公司的PEBAX材料，PEBAX材料不仅是具有介于热塑性塑料和橡胶之间的许多独特动态机械性能的材料，还具有优异的抗静电性能。
需要说明的是，医疗器械10中，密封结构不限于上述的第一密封件151，密封结构也可以设置 在导管11的远端。
结合图16所示，在一些实施方式中，医疗器械10包括连接于导管11的远端的密封结构20，利用该密封结构20可以发挥前述实施方式的第一密封件151的作用，确切的说，该密封结构20即可以满足导丝10a的穿过需要，同时，也能够在导丝10a移除时起到良好的密封作用，使得血液不会从导管11进入旋转轴122的第一导丝腔122a，以及灌注液不会从导管11输出，以提升医疗器械10整体操作便捷性及安全性。
具体地，密封结构20包括连接件21、限位盖22以及夹持于连接件21与限位盖22之间的第二密封件23，连接件21与导管11的远端相连接，连接件21具有导管11相连通的第一导丝孔21a，限位盖22具有与第一导丝孔21a相对应的第二导丝孔22a，第二密封件23具有供导丝10a穿过的中心孔23a，且第二密封件23被配置为受挤压而使得中心孔23a处于封闭状态。
连接件21与导管11之间、以及连接件21与限位盖22之间具体可以采取胶水相连，也可以采取热熔连接或螺纹连接的方式相连，在此不做限定。
第二密封件23采用弹性高分子材料制成，例如第二密封件23采用硅胶或橡胶等材料，从而第二密封件23具有一定的压缩、变形及恢复能力。如图17所示，第二密封件23在装配前呈现原始状态，其形状大体为一个具有中心孔23a的圆柱体，外径大小与限位盖22的内径应该相近或相等，以保证能安装到限位盖22的内腔中。第二密封件23的中心孔23a具有一定倾斜角度，呈上下两个漏斗形状，即朝远离第二密封件23中部的方向上，中心孔23a的直径逐渐增大。结合图18所示，连接件21和限位盖22装配好后会形成一个空腔，第二密封件23就安装在此空腔内，此时，第二密封件23因受到限位盖22与连接件21的挤压，且第二密封件23的外径被限位盖22限制，第二密封件23被压缩的体积将向中心轴移动，使得中心孔23a被封闭，继而密封结构20达到了维持对导管11进行密封的效果。结合图19所示，第二密封件23处于压缩状态下，第二密封件23的上下端面对应中心孔23a的位置仍具有漏斗型结构，这将有助于导丝10a的穿过。当导丝10a穿过后，由于第二密封件23具有一定压缩能力，第二密封件23的中心孔23a的孔壁与导丝10a密封接触，且允许导丝10a顺利通过。当介入操作结束后，将导丝10a撤出，第二密封件23重新恢复到封闭中心孔23a的状态，以保证手术过程中的密封性能。
接下来以其中一个实施方式的医疗器械10为例，对医疗器械10的介入操作过程加以说明。
首先由医生进行股动脉穿刺手术，将导丝10a从股动脉插入体内，经主动脉和主动脉弓后，导丝10a头端跨过瓣膜进入心室，导丝10a末端位于体外。随后开始经皮介入手术，首先将外鞘管18相对内管17朝远端移动，将可折叠泵组件12压缩收折至外鞘管18内，以达到介入尺寸，满足介入需要。随后将导丝10a末端从导管11的远端插入，并继续推送医疗器械10，使得导丝10a通过导管11进入第一导丝腔122a。需要说明的是，在旋转轴122和导管11之间连接有第一支撑组件15的实施方式中，导丝10a通过导管11进入第一导丝腔122a前，会先穿过第一支撑组件15的第一密封件151，然后进入第一导丝腔122a。
在导丝10a穿过第一导丝腔122a后，便会进入传动轴13的第二导丝腔13a，并沿第二导丝腔13a进入从动轴的第三导丝腔。这样，在将医疗器械10沿导丝10a朝远端移动以进行介入操作过程中，导丝10a穿过诸如导管11、可折叠泵组件12、传动轴13和从动轴这些结构，以引导这些结构顺利进入体内。
需要说明的是，在安装座141连接有密封堵头的实施方式中，导丝10a末端从第三导丝腔穿出后，继续将安装座141沿导丝10a朝远端移动，便可以使得导丝10a穿过过丝孔，从安装座141的近端穿出。可理解地，结合图3所示，安装座141的近端可以设置与过丝孔相对应的孔，从而使得导丝10a可以从安装座141的近端穿出。在导丝10a末端从安装座141的近端穿出后，相当于导丝10a穿过整个医疗器械10，此时，便可以沿导丝10a将医疗器械10朝远端移动，将医疗器械10介入人体。由于导丝10a从医疗器械10的远端的导管11穿入并从安装座141的近端穿出，因此，在介入过程中医疗器械10会沿体内导丝10a导引的路径顺利完成跨主动脉弓和跨瓣膜的操作。
当可折叠泵组件12展开并完全进入心室后，将导丝10a从安装座141的近端抽出，完成整个介 入手术的操作。
在医疗器械10辅助支持阶段，当通过灌注口向安装座141的管腔注入灌注液(例如生理盐水)时，灌注液一部分流入收容腔，以对从动轴进行润滑和降温；另一部分将经过内管17、传动轴13、弹簧管19等管件流向可折叠泵组件12，以润滑旋转轴122，从而降低可折叠泵组件12泵液过程中旋转轴122或传动轴13等结构因摩擦产生的温度。
由于第一密封件151和密封堵头均能够满足导丝10a的穿过，并且在导丝10a移除时能够起到密封作用，因此，当通过灌注口向安装座141的管腔注入灌注液时，在第一密封件151的作用下，流向可折叠泵组件12的灌注液不会经导管11进入体内，相应地，血液也不会从导管11进入可折叠泵组件12。在密封堵头的作用下，流入收容腔的灌注液不会从安装座141的近端渗出。由此可见，利用本申请的医疗器械10辅助泵血过程中，在体外灌注压力保持不变的情况下，能够有效减少灌注液的灌注量，以达到降低患者心脏负荷的目的，从而降低手术风险。
需要说明的是，经过内管17、传动轴13、弹簧管19等管件流向可折叠泵组件12的灌注液，有一部分会进入第二支撑组件16和旋转轴122之间的间隙，以在第二支撑组件16和旋转轴122之间发挥良好的润滑效果；另一部分则经传动轴13的第二导丝腔13a流向旋转轴122的第一导丝腔122a。由于第一密封件151可以在旋转轴122和导管11之间起到密封效果，从而灌注液无法流入导管11，转而会进入从第一支撑组件15和旋转轴122之间的间隙，以在第一支撑组件15与旋转轴122之间发挥良好的润滑效果。
灌注液包括但不限于生理盐水，在一些实施方式中，灌注液还可以是其他用于润滑的润滑液或用于冷却的冷却液。
需要说明的是，在本申请的实施方式中，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连接”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连接，也可以通过中间媒介间接相连接，可以是两个元件内部的连通或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (20)

  1. 一种医疗器械，其特征在于，包括：
    导管；
    可折叠泵组件，与所述导管的近端相连接，所述可折叠泵组件包括支撑网、桨叶以及用于带动所述桨叶转动的旋转轴，所述支撑网被配置为包覆于所述桨叶的周侧且能够径向扩张和收缩，所述旋转轴具有与所述导管相连通的第一导丝腔所述第一导丝腔被配置为能够供导丝穿过，且所述第一导丝腔能够从远端输出灌注液；及
    密封结构，与所述导管相连接，所述密封结构被配置为能够供所述导丝穿过且当所述导丝移除时能够密封所述导管。
  2. 根据权利要求1所述的医疗器械，其特征在于，包括第一支撑组件和第二支撑组件，所述第一支撑组件与所述支撑网的远端固定连接，所述第二支撑组件与所述支撑网的近端固定连接，所述第一支撑组件至少部分设置于所述旋转轴与所述导管之间，所述第一支撑组件和所述第二支撑组件被配置为能够共同支撑所述旋转轴旋转运动。
  3. 根据权利要求2所述的医疗器械，其特征在于，所述第一支撑组件具有用于连通所述导管与所述第一导丝腔的过丝通道，所述密封结构包括设置于所述过丝通道的第一密封件，所述第一密封件被配置为能够供所述导丝穿过所述过丝通道且当所述导丝移除时能够密封所述过丝通道。
  4. 根据权利要求3所述的医疗器械，其特征在于，所述第一密封件为硅胶材质，且所述第一密封件沿所述过丝通道的轴向上的厚度为0.1mm至1.0mm。
  5. 根据权利要求4所述的医疗器械，其特征在于，所述第一密封件的朝向所述旋转轴的一侧设有至少一个径向切口，沿所述过丝通道的轴向上，所述径向切口的深度为所述第一密封件的厚度的30％至70％。
  6. 根据权利要求4所述的医疗器械，其特征在于，所述第一密封件包括至少2个层叠设置的硅胶垫，且距离所述导管最近的所述硅胶垫设置有穿孔，所述穿孔被配置为能够供所述导丝穿过且当所述导丝移除时能够闭合。
  7. 根据权利要求4所述的医疗器械，其特征在于，所述第一密封件的朝向所述旋转轴的一侧设有至少一个径向切口，沿所述过丝通道的轴向上，所述径向切口的深度为所述第一密封件的厚度的30％至70％；所述第一密封件包括至少2个层叠设置的硅胶垫，且距离所述导管最近的所述硅胶垫设置有穿孔，所述穿孔被配置为能够供所述导丝穿过且当所述导丝移除时能够闭合。
  8. 根据权利要求3所述的医疗器械，其特征在于，所述第一支撑组件包括相互连接的第一支撑件和第二支撑件，所述第一支撑件与所述导管相连接，且具有第一通孔，所述第二支撑件与所述旋转轴相连，且具有第二通孔，所述第一支撑件和所述第二支撑件之间形成安装腔，所述第一通孔和所述第二通孔均与所述安装腔相连通，三者共同形成所述过丝通道，所述第一密封件设置于所述安装腔内。
  9. 根据权利要求1-8任一项所述的医疗器械，其特征在于，所述密封结构包括连接件、限位盖以及夹持于所述连接件与所述限位盖之间的第二密封件，所述连接件与所述导管的远端相连接，所述连接件具有所述导管相连通的第一导丝孔，所述限位盖具有与所述第一导丝孔相对应的第二导丝孔，所述第二密封件具有供所述导丝穿过的中心孔，且所述第二密封件被配置为受挤压而使得所述中心孔处于封闭状态。
  10. 根据权利要求9所述的医疗器械，其特征在于，所述中心孔呈上下两个漏斗形状，且朝远离所述第二密封件中部的方向上，所述中心孔的直径逐渐增大。
  11. 根据权利要求2所述的医疗器械，其特征在于，包括内管和套设于所述内管外的外鞘管，所述内管的远端与所述支撑网的近端相连接，所述外鞘管被配置为能够相对所述内管朝远端移动以收容所述可折叠泵组件。
  12. 根据权利要求11所述的医疗器械，其特征在于，所述第一支撑组件设置有沿其周侧延伸的凸起结构，所述凸起结构的表面与所述导管的外壁平滑过渡，所述外鞘管被配置为能够相对所述内管移动至与所述凸起结构相抵。
  13. 根据权利要求3所述的医疗器械，其特征在于，包括内管和套设于所述内管外的外鞘管，所述内管的远端与所述支撑网的近端相连接，所述外鞘管被配置为能够相对所述内管朝远端移动以收容所述可折叠泵组件，所述第一支撑组件设置有沿其周侧延伸的凸起结构，所述凸起结构的表面与所述导管的外壁平滑过渡，所述外鞘管被配置为能够相对所述内管移动至与所述凸起结构相抵，所述第一支撑组件具有用于连通所述导管与所述第一导丝腔的过丝通道，所述密封结构包括设置于所述过丝通道的第一密封件，所述第一密封件和所述凸起结构在所述第一支撑组件的轴向上的位置相对应，所述第一密封件被配置为能够供所述导丝穿过所述过丝通道且当所述导丝移除时能够密封所述过丝通道。
  14. 根据权利要求12或13所述的医疗器械，其特征在于，所述凸起结构开设有凹槽，所述凹槽的开口朝向所述凸起结构的近端侧，当所述外鞘管相对所述内管朝移动至所述与所述凸起结构相抵时，所述外鞘管的远端收容于所述凹槽内。
  15. 根据权利要求14所述的医疗器械，其特征在于，所述凸起结构沿所述第一支撑组件的周侧延伸1/4圆周或2/3圆周，所述凹槽为弧形槽。
  16. 根据权利要求14所述的医疗器械，其特征在于，所述凸起结构沿第一支撑组件15的周侧延伸一周，所述凹槽为环形槽。
  17. 根据权利要求11或13所述的医疗器械，其特征在于，包括传动轴和驱动组件，所述传动轴的远端与所述旋转轴相连接，所述内管套设于所述传动轴外，所述传动轴能够相对所述内管转动，所述驱动组件用于驱使所述传动轴相对所述内管转动，所述驱动组件包括安装座、驱动件和从动件，所述安装座与所述内管的近端相连接，所述驱动件包括电机和驱动磁钢，所述电机用于驱使所述驱动磁钢转动，所述从动件与所述安装座转动连接，所述从动件包括从动磁钢和从动轴，所述从动磁钢被配置为能够与所述驱动磁钢磁耦合，以在所述驱动磁钢转动时，所述从动磁钢在所述驱动磁钢的磁场作用下转动，所述从动轴连接于所述从动磁钢，并用于带动所述传动轴转动；所述传动轴具有第二导丝腔，所述从动轴具有第三导丝腔，所述第三导丝腔经所述第二导丝腔与所述第一导丝腔相连通。
  18. 根据权利要求17所述的医疗器械，其特征在于，所述安装座设有管腔、与所述管腔相连通的收容腔以及灌注口，所述从动轴的部分结构位于所述管腔内，所述从动磁钢位于所述收容腔内，所述灌注口用于向所述管腔注入所述灌注液。
  19. 根据权利要求18所述的医疗器械，其特征在于，所述安装座连接有密封堵头，所述密封堵头用于密封所述收容腔的近端侧，所述密封堵头具有过丝孔且所述密封堵头被配置为能够引导所述导丝从所述过丝孔穿出所述从动件的近端且当所述导丝移除时能够密封所述过丝孔。
  20. 根据权利要求17所述的医疗器械，其特征在于，包括弹簧管，所述弹簧管套设于所述传动轴与所述内管之间。
PCT/CN2022/113041 2022-07-01 2022-08-17 医疗器械 WO2024000758A1 (zh)

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