WO2024114761A1 - 管腔开通器械、管腔开通系统及管腔开通方法 - Google Patents

管腔开通器械、管腔开通系统及管腔开通方法 Download PDF

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Publication number
WO2024114761A1
WO2024114761A1 PCT/CN2023/135636 CN2023135636W WO2024114761A1 WO 2024114761 A1 WO2024114761 A1 WO 2024114761A1 CN 2023135636 W CN2023135636 W CN 2023135636W WO 2024114761 A1 WO2024114761 A1 WO 2024114761A1
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WO
WIPO (PCT)
Prior art keywords
inner tube
expansion
tube
lumen opening
contraction
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PCT/CN2023/135636
Other languages
English (en)
French (fr)
Inventor
刘颖
宋涛
杜蜀
董永贺
朱明哲
杨峥
Original Assignee
北京华通集智医疗器械有限公司
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Application filed by 北京华通集智医疗器械有限公司 filed Critical 北京华通集智医疗器械有限公司
Publication of WO2024114761A1 publication Critical patent/WO2024114761A1/zh

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Classifications

    • 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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/2202—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 using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • 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
    • A61B17/22004—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 using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B2017/22005—Effects, e.g. on tissue
    • A61B2017/22007—Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing

Definitions

  • the present disclosure relates to the technical field of medical devices, and in particular to a lumen opening device, a lumen opening system and a lumen opening method.
  • Intraluminal interventional therapy has become the preferred treatment for many diseases due to its minimally invasive nature.
  • Common instruments for intraluminal interventional therapy include guidewires, balloons, stents, volume reduction devices, etc.
  • the treatment process at least includes: first, the guidewire is pushed through the puncture port along the human lumen to the lesion site. In order to avoid damaging the lumen during the pushing process, the tip of the guidewire is generally soft. After the guidewire reaches the lesion site, it cannot pass through the lesion directly.
  • the occluded segment is accompanied by a hard fibrous cap and calcified plaques with a hard texture.
  • a known ultrasonic energy transmission system includes a generator, a transducer assembly (ultrasonic handle) and a catheter or guidewire, the generator is configured to generate, control, amplify and/or transmit an alternating electronic signal (e.g., a voltage signal) of a desired frequency to the transducer assembly;
  • the transducer assembly typically includes one or more piezoelectric ceramics, which expand and contract at a high frequency when excited by a high-frequency electronic signal; these high-frequency vibrations are amplified by a horn into ultrasonic energy, which is transmitted to the catheter or guidewire; the ultrasonic energy is transmitted to the distal end of the catheter or guidewire to ablate and/or otherwise destroy body lesions.
  • the purpose of the present disclosure includes providing a lumen opening device, a lumen opening system and a lumen opening method, which alleviate the problem that in the existing intracavitary interventional treatment surgery for occlusive lesions, the device is difficult to pass through the occluded segment of the lesion, the operation is complicated due to the switching of opening and expansion devices, and the balloon expansion volume reduction effect is not good and a stent needs to be inserted, and the restenosis in the stent leads to a low long-term patency rate, thereby improving the immediate success rate of the operation and the medium- and long-term effects.
  • the present disclosure provides a lumen opening device, which includes an inner tube assembly and an outer tube assembly.
  • the inner tube assembly includes an inner tube and an ultrasonic joint assembly connected to the proximal end of the inner tube;
  • the outer tube assembly includes an outer tube and at least one expansion and contraction portion connected to the distal end of the outer tube.
  • the outer tube and the at least one expansion and contraction portion are both sleeved on the outside of the inner tube; the expansion and contraction portion is configured to have a contraction state in which the outer tube is integrally fitted or close to the outer wall of the inner tube and an expansion state in which the inner tube is expanded radially toward the outside of the inner tube, and the outer tube assembly can move relative to the inner tube so that the expansion and contraction portion can be mutually transformed between the expansion state and the contraction state.
  • the ultrasonic device generally includes an ultrasonic generator and an ultrasonic transducer that are connected to each other. Some ultrasonic devices also include a foot-driven pedal. The ultrasonic generator can be driven by the foot-driven pedal to start the ultrasonic device. There are also some ultrasonic devices with other driving methods, which are all prior arts and will not be described in detail in this disclosure.
  • the first step is to start the ultrasonic device and use ultrasonic energy to open the occluded area.
  • This opening method mainly uses a combination of mechanical vibration and cavitation.
  • the lumen is opened with the help of ultrasonic energy.
  • the mechanical vibration of the ultrasonic frequency is transmitted along the opening device to the lesion.
  • the high-frequency vibration of the device will produce cavitation, and tiny bubbles will be generated around the lesion. These tiny bubbles will oscillate in the alternating periodic vibration waves.
  • the bubbles will be alternately stretched and compressed. When the bubbles are compressed to the point of collapse, instantaneous pressure will be generated. This instantaneous pressure jump forms a shock wave.
  • the explosion of countless bubbles is like countless micro-bombs, which damage the internal structure of the occluded section and allow the device to quickly pass through the lesion while expanding the lumen.
  • the high-frequency and low-amplitude mechanical vibration generated by ultrasound can make the distal end of the inner tube break through the hard fiber like a vibrating "hammer".
  • the high-frequency vibration of the inner tube generates a strong negative and positive pressure cycle in the surrounding fluid.
  • the distal end of the inner tube is retracted, the dissolved gas on the negative side of the pressure cycle will form cavitation bubbles, which will quickly burst on the positive side of the pressure cycle.
  • the bursting of the cavitation bubbles will produce a strong mechanical shock wave, which will erode the calcified plaques.
  • the occluded segment of therapeutic ultrasound can be reopened, and it also has the characteristics of plaque ablation selectivity.
  • Tissues with high collagen and elastin content are extremely resistant to ultrasonic damage, but tissues lacking these components are easily damaged.
  • High-intensity ultrasound destroys fibrous or calcified plaques, but will not damage normal arterial blood vessels.
  • This occluded segment opening method is more efficient, which is conducive to greatly shortening the occluded segment opening time during surgery, and avoids the problem of the occluded segment being too hard and the guide wire cannot pass through, thereby improving the success rate of occluded segment opening.
  • the second step is to operate the outer tube assembly to move the outer tube assembly relative to the inner tube, so that each expansion and contraction part changes from a contracted state to an expanded state, thereby expanding the hole opened in the first step to further expand the inner cavity size of the occluded section, and at the same time support the inner tube, thereby indirectly improving the support force for the guide wire inserted into the inner tube.
  • the guide wire Under the action of the strong support force, the guide wire can have a strong directionality and is not easy to bend, thereby further shortening the opening time of the occluded section and improving the opening efficiency of the occluded section;
  • the first and second steps mentioned above can also be performed in the reverse order, that is, first operate the outer tube assembly to move the outer tube assembly relative to the inner tube, so that each expansion and contraction part is transformed from a contracted state to an expanded state, and the expansion and contraction part in the expanded state supports the inner tube, and then the ultrasonic equipment is started to open the occluded part with the help of ultrasonic energy.
  • the first and second steps mentioned above are performed alternately according to the needs of the operator.
  • the lumen opening device provided in this embodiment alleviates the problem that the device is difficult to pass through the occluded segment of the lesion in the existing intracavitary interventional treatment of occluded lesions, and achieves a good effect of shortening the opening time of the occluded segment and improving the opening efficiency of the occluded segment.
  • the surgical instruments are not replaced during the entire process of opening and expanding the occluded segment of the lesion, thereby alleviating the cumbersome operation caused by the change of opening and expansion instruments in the existing intracavitary interventional treatment of occlusive lesions, as well as the problem of poor volume reduction due to balloon expansion and the need to insert a stent, and restenosis in the stent leading to low long-term patency rate.
  • the lumen opening instrument provided in this embodiment is simpler and more convenient to use, and the operation process is faster and more convenient, which is conducive to further improving the surgical efficiency, reducing the surgical risks of various complications caused by excessive operation time, and further improving the immediate success rate of the operation and the medium- and long-term effects (it should be noted that the effect that can be achieved by the lumen opening instrument provided by the present disclosure is only relative to the lumen opening instrument provided by the prior art and most patient conditions. Since there are many factors affecting the operation during actual surgical treatment, this does not mean that the use of the lumen opening instrument provided by the present disclosure can guarantee the absolute safety and effectiveness of the treatment of patients with any related diseases).
  • the distal end of the inner tube extends out of the portion of the at least one expansion and contraction portion that is closest to the distal end of the inner tube. In a further preferred embodiment, the distal end of the inner tube extends out of the portion of the at least one expansion and contraction portion that is closest to the distal end of the inner tube.
  • the expansion and contraction portion closest to the distal end of the inner tube is the distal expansion and contraction portion: in some optional implementations of the embodiments of the present disclosure, the expansion and contraction portion only includes the distal expansion and contraction portion, that is, there is one and only one expansion and contraction portion; in other optional implementations of the embodiments of the present disclosure, there are at least two expansion and contraction portions, and the expansion and contraction portion farthest from the distal end of the inner tube is the proximal expansion and contraction portion, wherein: the at least two expansion and contraction portions are connected end to end in sequence, and the distal end of the outer tube is connected to the proximal end of the proximal expansion and contraction portion; or, the outer tube includes a proximal tube and multiple sections of distal tubes, the at least two expansion and contraction portions are spaced apart in pairs, and two adjacent expansion and contraction portions are connected by at least one section of the distal tube, and the distal end of the proximal tube is connected to the proximal end of the proximal expansion and contraction
  • the portion of the at least one expansion and contraction portion closest to the distal end of the inner tube is fixed to the distal outer wall of the inner tube.
  • the outer tube can rotate relative to the inner tube so that the expansion and contraction portion can be mutually transformed between the expansion state and the contraction state; or, further optionally, the outer tube can slide back and forth relative to the inner tube so that the expansion and contraction portion can be mutually transformed between the expansion state and the contraction state.
  • a limiting structure is provided on the distal outer wall of the inner tube, and the portion of the at least one expansion and contraction portion closest to the distal end of the inner tube is limited by the limiting structure to the distal outer wall of the inner tube.
  • the distal end of the distal expansion and contraction portion is also connected to a restraining and fixing component, which is used as a portion fixedly connected to the outer wall of the distal end of the inner tube in some of the above embodiments, or as a portion limited by a limiting component in some of the above other embodiments.
  • the restraining and fixing component includes a fixing ring or a fixing tube, and the fixing ring or the fixing tube is sleeved on the outside of the inner tube. ;
  • the distal outer wall of the inner tube is provided with the above-mentioned limiting structure, the distal end of the distal expansion and contraction part is connected to the above-mentioned constraint and fixing component, the constraint and fixing component is limited by the limiting structure to the distal outer wall of the inner tube, and the outer tube can slide back and forth relative to the inner tube so that the expansion and contraction part can be transformed between the expansion state and the contraction state.
  • the limiting structure on the distal outer wall of the inner tube mentioned above includes a distal blocking protrusion, and the constraint and fixing component of the distal expansion and contraction part is blocked at the proximal side of the distal blocking protrusion.
  • the limiting structure also includes a proximal blocking protrusion, and the proximal blocking protrusion is located on the proximal side of the constraint and fixing component of the distal expansion and contraction part.
  • the outer tube assembly further comprises an outer sheath tube, which is sleeved on the outside of the outer tube, and the outer sheath tube can slide back and forth relative to the outer tube to close or release the expansion and contraction portion on the outer sheath tube.
  • the expansion and contraction portion includes a skeleton, and the skeleton is in a grid shape or is formed by a plurality of connecting wires extending along the axial direction of the inner tube and arranged at intervals. Further, more preferably but not limited to, the expansion and contraction portion also includes a coating connected to the skeleton, and the coating is made of a flexible material.
  • the outer layer tube assembly also includes a sealing device, and the sealing device is configured to be able to radially seal the tube gap between the proximal inner wall of the outer tube and the outer wall of the inner tube.
  • the outer tube assembly also includes a sliding handle, which is connected to the proximal end of the outer tube and sleeved on the outside of the inner tube, and the sliding handle is configured to drive the outer tube to slide forward and backward relative to the inner tube.
  • the sealing device is disposed between the inner wall of the sliding handle and the outer wall of the inner tube to radially seal the gap between the inner wall of the sliding handle and the outer wall of the inner tube, thereby indirectly radially sealing the gap between the proximal inner wall of the outer tube and the outer wall of the inner tube.
  • a handle liquid through hole is provided on the sliding handle, and the handle liquid through hole is connected to the gap between the outer tube and the inner tube; and the handle liquid through hole is located at the distal side of the sealing device.
  • the sealing device is disposed in a tube gap between a proximal inner wall of the outer tube and an outer wall of the inner tube, thereby directly radially sealing the gap between the proximal inner wall of the outer tube and the outer wall of the inner tube.
  • a sliding position mark is provided on the sliding handle, and the proximal outer wall of the inner tube is provided with scale lines arranged along the axial direction of the inner tube, and the sliding position mark and the scale lines cooperate with each other to display the distance that the outer tube slides forward and backward relative to the inner tube.
  • an outer tube liquid through hole penetrating the tube wall of the outer tube is provided on the proximal wall of the outer tube.
  • an inner tube liquid through hole penetrating the tube wall of the inner tube is provided on the proximal wall of the inner tube.
  • the ultrasonic connector assembly includes an ultrasonic connector; the proximal end of the ultrasonic connector is provided with a connecting portion configured to be connected to an ultrasonic transducer; the ultrasonic connector is provided with an inner tube connecting hole and a connector liquid through hole, the proximal end of the inner tube is connected to the distal end of the inner tube connecting hole and the lumen of the inner tube is connected to the inner tube connecting hole, and the connector liquid through hole is connected to the inner tube connecting hole.
  • the ultrasonic connector assembly also includes a hose and a one-way valve assembly; one end of the hose is connected to the liquid hole of the connector, and a portion of the hose away from the liquid hole of the connector is connected to a one-way valve assembly that only allows liquid to flow from the hose through the liquid hole of the connector into the inner tube connecting hole.
  • an embodiment of the present disclosure provides a lumen opening system, comprising an ultrasonic generator, an ultrasonic transducer, and a lumen opening device as described in any one of the aforementioned embodiments, wherein the ultrasonic transducer is connected to the ultrasonic generator, and the ultrasonic connector assembly is connected to the ultrasonic transducer.
  • the embodiment of the present disclosure also provides a lumen opening method, which uses the lumen opening system described in the second aspect to deliver the distal end of the lumen opening device into the occlusion in the patient's blood vessel cavity, start the ultrasonic generator, and drive the inner tube to vibrate. While the inner tube is ultrasonically vibrating, the ultrasonic energy of the inner tube can be transmitted to the expansion and contraction part connected to the distal end of the outer tube, so that the expansion and contraction part in the expanded state can cut the thrombus.
  • the lumen opening method provided in the embodiment of the present disclosure applies the aforementioned lumen opening system
  • the lumen opening system also includes the aforementioned lumen Opening device, therefore, the lumen opening method and lumen opening system provided by the embodiments of the present disclosure can achieve all the beneficial effects that the aforementioned lumen opening device can achieve.
  • FIG1 is a schematic diagram of the overall structure of the lumen opening device provided by an embodiment of the present disclosure, when the expansion and contraction portion is in an expanded state;
  • FIG2 is an enlarged view of the local structure of part A in FIG1;
  • FIG3 is a schematic diagram of the overall structure of the lumen opening device provided by an embodiment of the present disclosure, when the expansion and contraction portion is in a contracted state;
  • FIG4 is an enlarged view of the local structure of the A' portion in FIG3;
  • FIG5 is a schematic diagram of a first optional structure of the expansion and contraction portion of the lumen opening device provided in an embodiment of the present disclosure
  • FIG6 is a schematic diagram of a second optional structure of the expansion and contraction portion of the lumen opening device provided in an embodiment of the present disclosure
  • FIG. 7 is a schematic diagram of a third optional structure of the expansion and contraction portion in the lumen opening device provided in an embodiment of the present disclosure.
  • FIG8 is a schematic diagram of a fourth optional structure of the expansion and contraction portion of the lumen opening device provided in an embodiment of the present disclosure.
  • FIG9 is a schematic diagram of an expanded state of a connection structure between the distal end of the distal expansion and contraction portion and the inner tube in the lumen opening device provided by an embodiment of the present disclosure
  • FIG10 is a schematic diagram of a contracted state of the connection structure between the distal end of the distal expansion and contraction portion and the inner tube shown in FIG9 ;
  • FIG11 is a schematic diagram of an expanded state of another connection structure between the distal end of the distal expansion and contraction portion and the inner tube in the lumen opening device provided by an embodiment of the present disclosure
  • FIG12 is a schematic diagram of a contracted state of the connection structure between the distal end of the distal expansion and contraction portion and the inner tube shown in FIG11;
  • FIG. 13 is a cross-sectional view of the overall structure of the sliding handle in some optional implementations of the lumen opening device provided in the embodiment of the present disclosure
  • FIG. 14 is a cross-sectional view of the overall structure of the ultrasonic connector in some optional implementations of the lumen opening device provided in the embodiment of the present disclosure
  • FIG15 is a schematic diagram of the overall structure of the lumen opening system provided in an embodiment of the present disclosure.
  • FIG16 is a schematic diagram of the distal end opening stage of the catheter when the lumen opening device or lumen opening system provided by the embodiment of the present disclosure is used for surgical treatment;
  • FIG17 is a schematic diagram of a stage in which the expansion and contraction section enters the occlusion section when the lumen opening device or lumen opening system provided by an embodiment of the present disclosure is used for surgical treatment;
  • FIG18 is a schematic diagram of the expansion phase of the expansion and contraction section when the lumen opening device or lumen opening system provided by the embodiment of the present disclosure is used for surgical treatment;
  • FIG19 is a schematic diagram of the distal assembly structure between the outer sheath tube and the outer tube and the inner tube when the outer tube assembly includes an outer sheath tube in the lumen opening device provided by an embodiment of the present disclosure
  • FIG20 is a schematic diagram of the matching structure of the sliding position mark on the sliding handle and the scale line on the inner tube in the lumen opening device provided in an embodiment of the present disclosure
  • FIG21 is a schematic diagram of the tip structure of the distal end of the inner tube in some embodiments.
  • FIG. 22 is a partial schematic diagram of a tube layer structure in which an outer tube liquid through hole is provided at the proximal end of the outer tube and an inner tube liquid through hole is provided at the proximal end of the inner tube in some embodiments.
  • Icons 1-inner tube; 101-tip; 102-scale line; 103-inner tube liquid hole; 11-limiting structure; 111-distal blocking protrusion; 112-proximal blocking protrusion; 2-ultrasonic joint assembly; 21-ultrasonic connector; 210-connecting part; 211-inner tube connecting hole; 212-connecting head liquid hole; 22-hose; 23-one-way valve assembly; 3-outer tube; 31-liquid spray hole; 32-outer tube liquid hole; 4-expansion and contraction part; 41-skeleton; 42-constraint fixing component; 5-sliding handle; 501-sliding position mark; 51-handle liquid hole; 52-sealing device; 6-ultrasonic generator; 7-ultrasonic transducer; 8-foot driving pedal; 9-outer sheath.
  • the terms “upper”, “lower”, “vertical”, “horizontal”, “inner”, “outer”, etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, or the positions or positional relationships in which the inventive product is usually placed when in use, which are only for the convenience of describing the present disclosure and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present disclosure.
  • the terms “first”, “second”, “third”, etc. are only configured to distinguish descriptions, and cannot be understood as indicating or implying relative importance.
  • the terms "setting”, “installation”, and “connection” should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be the internal communication of two elements.
  • the specific meanings of the above terms in the present disclosure can be understood according to specific circumstances.
  • the end of the medical device close to the operator during surgery is the proximal end of the medical device
  • the end of the medical device entering the patient's blood vessel is the distal end of the medical device
  • the front end of the medical device is the distal end
  • the rear end of the medical device is the proximal end
  • the axial direction refers to the direction parallel or substantially parallel to the line connecting the distal center and the proximal center of the medical device
  • the radial direction refers to the direction perpendicular or substantially perpendicular to the above-mentioned axial direction.
  • Intraluminal interventional therapy is currently the preferred treatment for occlusive lesions caused by atherosclerosis.
  • Commonly used instruments for intraluminal interventional therapy include guide wires, balloons, stents, volume reduction devices, etc.
  • the treatment process at least includes: first, the guide wire is pushed through the puncture port along the human body lumen to the lesion site. In order to avoid damaging the blood vessels during the pushing process, the head end of the guide wire is generally soft. After the guide wire reaches the lesion site, the distal end (front end) of the guide wire cannot be directly used to open the occluded segment at the lesion.
  • the guide wire After the catheter is inserted, different types of guide wires need to be exchanged through the catheter until the guide wire can pass through the occluded lesion; second, the guide wire is pushed into the balloon catheter, thrombolytic catheter or other atherectomy-type volume reduction device to further expand the inner cavity size of the occluded segment. It can also be but not limited to stent implantation. The whole process requires the use of opening and dilation instruments alternately, which is cumbersome and time-consuming. In addition, for the first step, due to the occlusive lesions caused by atherosclerosis, the occluded segment is accompanied by hard fibrous caps and calcified plaques, which are hard in texture.
  • the guidewire opening process is time-consuming, damages the vascular wall, and the opening success rate is low.
  • the failure to open the occluded segment is currently one of the main problems that cause the failure of intracavitary interventional treatment of occlusive lesions.
  • the vascular retraction leads to poor expansion effect, and even causes thrombus detachment and vascular rupture.
  • vibration balloons, thrombolytic catheters, grinding catheters, suction catheters and other volume reduction devices have been developed. The purpose is to remove thrombi and calcification and provide a larger effective lumen diameter.
  • a stent When the volume reduction effect is not good, a stent needs to be placed to expand the lumen, but after the stent is placed, it will stimulate endothelial hyperplasia, leading to restenosis in the stent, and the medium- and long-term occlusion rate is very high.
  • the lumen opening device includes an inner tube assembly 100 and an outer tube assembly 200 .
  • the inner tube assembly 100 includes an inner tube 1 and an ultrasonic joint assembly 2, and the ultrasonic joint assembly 2 is connected to the proximal end of the inner tube 1;
  • the outer tube assembly 200 includes an outer tube 3 and at least one expansion and contraction portion 4 connected to the distal end of the outer tube 3.
  • the outer tube 3 and the expansion and contraction portions 4 are both sleeved on the outside of the inner tube 1, and each expansion and contraction portion 4 is configured to have a contraction state of integrally fitting or close to the outer wall of the inner tube 1 as shown in Figures 3 and 4, and an expansion state of bulging radially toward the outside of the inner tube 1 along the inner tube 1 as shown in Figures 1 and 2; the outer tube assembly 200 can move relative to the inner tube 1 so that the expansion and contraction portion 4 can be mutually transformed between these two states.
  • the inner tube 1 and the outer tube 3 are made of rigid or semi-rigid materials, for example but not limited to, the inner tube 1 and the outer tube 3 are metal tubes or metal braided composite tubes.
  • the ultrasonic connector assembly 2 at the proximal end of the inner tube 1 is connected to the ultrasonic transducer 7 of the ultrasonic device, and each expansion and contraction portion 4 is ensured to be in a contracted state, and then the distal end of the inner tube 1 of the lumen opening device is extended into the lesion occlusion; then:
  • the first step is to start the ultrasound device and use the ultrasound energy to open the occluded area.
  • This opening method mainly uses a combination of mechanical vibration and cavitation to open the lumen with the help of ultrasound energy.
  • the mechanical vibration of the ultrasound frequency moves along the opening device to the lesion.
  • the high-frequency vibration of the device will produce cavitation, and tiny bubbles will be generated around the lesion. These tiny bubbles will vibrate in the alternating cycle. Oscillations in the waves cause the bubbles to be stretched and compressed alternately. When the bubbles are compressed to the point of collapse, instantaneous pressure will be generated. This instantaneous pressure jump forms a shock wave.
  • the explosion of countless bubbles is like countless micro-bombs, which damage the internal structure of the occluded segment and allow the instrument to quickly pass through the lesion site while expanding the lumen.
  • the high-frequency, low-amplitude mechanical vibration generated by ultrasound can make the distal end of the inner tube 1 break through the hard fiber cap like a vibrating "hammer".
  • the high-frequency vibration of the inner tube 1 generates a strong negative and positive pressure cycle in the surrounding fluid.
  • the distal end of the inner tube 1 is retracted, the dissolved gas on the negative side of the pressure cycle will form cavitation bubbles, and the bubbles will quickly burst on the positive side of the pressure cycle.
  • the occluded segment of therapeutic ultrasound can be reopened, and it also has the characteristics of plaque ablation selectivity.
  • Tissues with high collagen and elastin content have extremely strong resistance to ultrasonic damage, but tissues lacking these components are easily damaged.
  • High-intensity ultrasound destroys fibrous or calcified plaques, but will not damage normal arterial blood vessels.
  • This occluded segment opening method is more efficient, which is conducive to greatly shortening the occluded segment opening time during surgery, and avoids the problem that the occluded segment is too hard and the guide wire cannot pass through, thereby improving the success rate of occluded segment opening.
  • the outer tube assembly 200 is operated to move the outer tube assembly 200 relative to the inner tube 1, so that each expansion and contraction portion 4 is changed from the contraction state shown in Figures 3 and 4 to the expansion state shown in Figures 1 and 2, thereby expanding the hole opened in the first step to further expand the inner cavity size of the occluded section, and at the same time supporting the inner tube 1, indirectly improving the support force for the guide wire (the guide wire is a conventional guide wire used for interventional surgery, not shown in the present disclosure) inserted into the inner tube 1. Under the action of the strong support force, the guide wire can have a strong directionality and is not easy to bend, thereby further shortening the opening time of the occluded section and improving the opening efficiency of the occluded section;
  • the first and second steps mentioned above can also be performed in the reverse order, that is, first operate the outer tube assembly 200 to move the outer tube assembly 200 relative to the inner tube 1, so that each expansion and contraction portion 4 is transformed from the contraction state shown in Figures 3 and 4 to the expansion state shown in Figures 1 and 2, and the expansion and contraction portion 4 in the expansion state supports the inner tube 1, and then the ultrasonic equipment is started to open the occluded area with the help of ultrasonic energy.
  • the first and second steps mentioned above are performed alternately according to the needs of the operator.
  • the lumen opening device provided in this embodiment alleviates the problem that the device is difficult to pass through the occluded segment of the lesion in the existing intracavitary interventional treatment of occlusive lesions, and achieves a good effect of shortening the opening time of the occluded segment and improving the opening efficiency of the occluded segment.
  • the surgical instrument is not replaced during the entire process of opening and expanding the occluded segment of the lesion, thereby alleviating the cumbersome operation caused by the switching of opening and expansion devices in the existing intracavitary interventional treatment of occlusive lesions, as well as the problem that the balloon expansion effect is not good and the volume reduction effect requires the placement of a stent, and the restenosis in the stent leads to a low long-term patency rate.
  • this embodiment The provided lumen opening device is simpler and more convenient to use, and the surgical process is faster and more convenient, which is conducive to further improving surgical efficiency, reducing the surgical risks of various complications caused by prolonged surgery, and further improving the immediate success rate of the surgery and the medium- and long-term effects (it should be noted that the effect that can be achieved by the lumen opening device provided by the present invention is only relative to the lumen opening device provided by the prior art and most patient conditions. Since there are many factors affecting the surgery during actual surgical treatment, this does not mean that the use of the lumen opening device provided by the present invention can guarantee the absolute safety and effectiveness of the treatment of patients with any related diseases).
  • a tip 101 is provided at the distal end of the inner tube 1.
  • the tip 101 can be a conical hollow guide head that is detachably connected or fixedly connected or integrally connected to the distal end of the inner tube 1 by snap-on, threaded connection, etc., or can be a sharp structure formed by gradually thinning the wall thickness of the inner tube 1 at the distal end in a direction from the proximal end of the inner tube 1 to the distal end.
  • the inner tube assembly 100 and the outer tube assembly 200 can also include more tube structures, which are matched with the inner tube 1 and the outer tube 3 shown in FIGS. 1 to 4 to meet other functional requirements.
  • the inner tube assembly 100 at least includes the inner tube 1 shown in FIG. 1 to FIG. 4
  • the outer tube assembly 200 at least includes the outer tube 3 mentioned above.
  • the distal end of the inner tube 1 can extend out of the part of these expansion and contraction parts 4 that is closest to the distal end of the inner tube 1, as shown in Figures 1 to 4. It can also be that the distal end surface of the inner tube 1 is flush with the distal end surface of the expansion and contraction part 4, or the distal end of the inner tube 1 is located inside the expansion and contraction part 4.
  • the distal end of the inner tube 1 extends out of the part of these expansion and contraction parts 4 that is closest to the distal end of the inner tube 1, so that during the ultrasonic opening process, the distal end of the inner tube 1 is not disturbed by the expansion and contraction part 4 and is in full contact with the occluded part, thereby ensuring that the distal end of the inner tube 1 quickly opens the occluded section of the lesion during the ultrasonic opening.
  • the expansion and contraction portion 4 closest to the distal end of the inner tube 1 is used as the distal expansion and contraction portion: in some optional embodiments, the expansion and contraction portion 4 only includes the distal expansion and contraction portion, that is, there is one and only one expansion and contraction portion 4.
  • the specific transformation mode of the outer tube 3 moving relative to the inner tube 1 so that the expansion and contraction portion 4 can transform between the expansion state shown in FIGS. 1 and 2 and the contraction state shown in FIGS. 3 and 4 includes at least the following two optional modes:
  • expansion and contraction parts 4 the part closest to the distal end of the inner tube 1 is fixed to the distal outer wall of the inner tube 1, or, as shown in FIG. 2 and FIG. 4, a limiting structure 11 is provided on the distal outer wall of the inner tube 1, and the part closest to the distal end of the inner tube 1 is limited by the limiting structure 11 to the distal outer wall of the inner tube 1, and the outer tube 3 controls the state change of the expansion and contraction part 4 by rotating or sliding forward and backward relative to the inner tube 1;
  • the expansion and contraction portion 4 includes a skeleton 41 , which is in a grid shape or is formed by a plurality of connecting wires extending axially along the inner tube 1 and arranged at intervals.
  • the part of the expansion and contraction part 4 closest to the distal end of the inner tube 1 needs to be fixed to the distal outer wall of the inner tube 1; the expansion and contraction part 4 is in an expanded state in a free state and has a certain resilience; in a contracted state, the expansion and contraction part 4 can be wrapped around the outer peripheral wall of the inner tube 1, and the expansion and contraction part 4 can be released by rotating relative to the inner tube 1, so that the expansion and contraction part 4 returns to the expanded state;
  • the outer tube 3 slides back and forth relative to the inner tube 1 to control the state change of the expansion and contraction part 4, so that the part closest to the distal end of the inner tube 1 is fixed to the distal outer wall of the inner tube 1, or, as shown in Figures 2 and 4, a limiting structure 11 is provided on the distal outer wall of the inner tube 1, and the part closest to the distal end of the inner tube 1 is limited by the limiting structure 11 to the distal outer wall of the inner tube 1; the expansion and contraction part 4 is in an expanded state in a free state and has a certain resilience, and in a contracted state, the outer tube 3 can straighten the expansion and contraction part 4 toward the proximal direction, relative to The inner tube 1 pushes the expansion and contraction part 4 forward to release the expansion and contraction part 4 so that the expansion and contraction part 4 returns to the expanded state, and the expansion and contraction part 4 can also be changed from a free state to a contracted state.
  • the expansion and contraction portion 4 connected to the distal end of the outer tube 3 is closest to the distal end of the inner tube 1, the portion thereof is fixed to the distal end of the inner tube 1.
  • the outer tube wall, or the outer tube wall limited by the limiting structure 11 at the distal end of the inner tube 1, that is, the expansion and contraction part 4 connected to the distal end of the outer tube 3 is fixed together (in contact) with the distal end of the inner tube 1, so that when the inner tube 1 ultrasonically vibrates, the ultrasonic energy of the inner tube 1 can be transmitted to the expansion and contraction part 4 connected to the distal end of the outer tube 3, and the outer layer tube assembly 200 moves relative to the inner tube 1, so that each expansion and contraction part 4 can be changed from a contracted state to an expanded state.
  • the expansion and contraction part 4 in the expanded state can cut the thrombus, get close to the blood vessel wall, and break up the calcified plaque attached to the wall, thereby further shortening the opening time of the occluded section and improving the opening efficiency of the occluded section.
  • the outer tube 3 can slide back and forth relative to the inner tube 1, so that the expansion and contraction part 4 can be mutually transformed between the expansion state and the contraction state, and the expansion and contraction part 4 preferably adopts the above-mentioned structure in which the free state is the contraction state.
  • This structure can adjust the expansion degree of the expansion state of the expansion and contraction part 4 by adjusting the push and pull degree of the outer tube 3 relative to the inner tube 1, so that the expansion and contraction part 4 can adapt to the opening of the blood wall or occluded section of various diameters, which is conducive to the better transmission of ultrasonic energy from the inner tube 1 to the thrombus and the blood wall through the expansion and contraction part 4. More specifically, when the outer tube 3 slides relative to the inner tube 1 toward the distal direction, the expansion and contraction part 4 changes from the contraction state to the expansion state, and when the outer tube 3 slides relative to the inner tube 1 toward the proximal direction, the expansion and contraction part 4 changes from the expansion state to the contraction state.
  • the outer tube assembly 200 further includes an outer sheath tube 9, which is sleeved on the outside of the outer tube 3, and the outer sheath tube 9 can slide back and forth relative to the outer tube 3 to gather or release the expansion and contraction portion 4 in the gap between the inner wall of the outer sheath tube 9 and the outer wall of the outer tube 3, thereby controlling the state transition of the expansion and contraction portion 4.
  • the expansion and contraction portion 4 is in an expanded state in a free state and has a certain resilience.
  • the expansion and contraction portion 4 is gathered in the gap between the inner wall of the outer sheath tube 9 and the outer wall of the outer tube 3, and the outer sheath tube 9 is withdrawn relative to the outer tube 3, and the expansion and contraction portion 4 can be slowly exposed at the distal end of the outer sheath tube 9. Finally, the expansion and contraction portion 4 is released in the aforementioned gap, and the expansion and contraction portion 4 returns to the expanded state.
  • the expansion and contraction portion 4 includes a skeleton 41, which can be processed by connecting wires in straight lines, curves, filaments, strips, meshes or spirals or other shapes.
  • the connecting wires can be but are not limited to metal materials or other high-performance non-metallic materials or composite materials, preferably made of metal materials such as stainless steel, nickel-titanium, cobalt-based or titanium-based; as shown in Figures 5 and 8, the skeleton 41 is in a grid shape, or, as shown in Figure 6, the skeleton 41 is composed of a plurality of connecting wires extending along the axial direction of the inner tube 1 and arranged at intervals, and the skeleton 41 can be formed by respectively constraining the proximal and distal ends of the connecting wires, or can be cut from an integral pipe and the middle portion is bulged as shown in Figure 7.
  • the expansion and contraction portion 4 closest to the distal end of the inner tube 1 is the distal expansion and contraction portion, and the outer tube 3 can rotate or slide back and forth relative to the inner tube 1 so that the expansion and contraction portion 4 can be mutually converted between the expansion state and the contraction state:
  • the distal end of the skeleton 41 of the distal expansion and contraction portion is fixedly connected to the distal outer wall of the inner tube 1 by integral connection, bonding, riveting, welding or other fixed connection methods.
  • the distal expansion and contraction portion further includes a restraining and fixing component 42 connected to the distal end of the skeleton 41, and the restraining and fixing component 42 of the distal expansion and contraction portion can be fixed to the distal outer wall of the inner tube 1, and the fixing method includes but is not limited to fixing by integral connection or bonding or riveting or welding or other fixed connection or by clamping, or the restraining and fixing component 42 is limited to the distal outer wall of the inner tube 1 by the limiting structure 11.
  • the structure of the restraining and fixing component 42 includes a fixing ring or a fixing tube, and the fixing ring or the fixing tube is sleeved on The outer part of the inner tube 1, and the restraining and fixing component 42 can be integrally formed with the skeleton 41 or welded separately or otherwise fixedly connected to the skeleton 41.
  • the limiting structure 11 includes a distal blocking protrusion 111, and the restraining and fixing component 42 of the distal expansion and contraction part is blocked at the proximal side of the distal blocking protrusion 111.
  • the restraining and fixing component 42 of the distal expansion and contraction part contacts the distal blocking protrusion 111, and the distal blocking protrusion 111 blocks the restraining protrusion 111 of the distal expansion and contraction part.
  • the fixing component 42 continues to slide in the distal direction relative to the inner tube 1, and then, the expansion and contraction part 4 is axially compressed and radially expanded to an expanded state.
  • the limiting structure 11 also includes a proximal blocking protrusion 112, which is located on the proximal side of the constraint fixing component 42 of the distal expansion and contraction part, and the proximal blocking protrusion 112 and the distal blocking protrusion 111 jointly limit the constraint fixing component 42.
  • the expansion and contraction portion 4 also includes a coating connected to the skeleton 41, and the coating is made of flexible materials such as PU (polyurethane), nylon, Pebax (nylon elastomer), PET (Polyethylene terephthalate), PTFE (Poly tetra fluoroethylene), PVF (polyvinyl-fluoride; Polyvinylformal), FEP (Fluorinated ethylene propylene), silicone rubber, PI (polyimide), etc.
  • the coating is configured to be coated with thrombolytic drugs or anti-endothelial hyperplasia drugs such as paclitaxel or rapamycin.
  • the coating is a bare film not coated with drugs, and in other optional embodiments, the coating is pre-coated with drugs.
  • the coating can be sutured or connected to the skeleton 41 by other methods such as coating, bonding, welding, dipping, spraying, etc., for example but not limited to: a solution capable of forming a film is prepared in advance, the solution can be made of a biocompatible material that is soluble in an organic solvent and a polymer, the skeleton 41 is immersed in the solution and taken out, because the gap between the connecting lines of the skeleton 41, especially the grid-like skeleton, is small, the surface tension of the solution can form a liquid film suspended in the gap of the skeleton 41, and after the solution evaporates, the polymer and other materials are left to form a thin film and then bonded to the surface of the skeleton 41, thereby forming a coating, the thickness of the coating can be controlled by the concentration of the solution or the number of coatings, or, by laser welding, the two
  • the drug can be attached to the surface of the coating by drug coating, spraying, dipping, etc., so as to achieve drug loading of the coating.
  • the purpose of setting the coating in this preferred embodiment is mainly to increase the contact area between the expansion and contraction part 4 and the diseased blood vessel wall in the expanded state, so as to adhere the granular drug or drug layer to the coating surface.
  • the drug By directly attaching the drug to the lesion, the drug is delivered, and the ultrasonic vibration cooperates with each other to make the drug fall off from the surface of the coating, and the drug dissolution is accelerated under the action of the ultrasonic vibration, and the drug is absorbed by the diseased tissue, so as to perform local treatment on the lesion.
  • anti-endothelial hyperplasia drugs such as rapamycin and paclitaxel
  • such drugs are toxic and should not be used in large quantities.
  • no coating is set, only by applying the drug layer on the skeleton 41, the contact area between the drug and the lesion is insufficient, and the dosage and the adhesion of the drug on the surface of the blood vessel wall are insufficient.
  • the above-mentioned method of contacting the lesion after the membrane is expanded not only improves the utilization rate of the drug, but also reduces the toxicity.
  • the outer tube assembly 200 further includes a sliding handle 5, which is connected to the proximal end of the outer tube 3 and is sleeved on the outside of the inner tube 1, and the sliding handle 5 is configured to drive the outer tube 3 to slide forward and backward relative to the inner tube 1.
  • the sliding handle 5 also has a A sliding position mark 501 is provided, and the proximal outer wall of the inner tube 1 is provided with a scale line 102 arranged along the axial direction of the inner tube 1.
  • the sliding position mark 501 and the scale line 102 cooperate with each other to display the distance that the outer tube 3 slides back and forth relative to the inner tube 1.
  • the sliding position mark 501 can be but is not limited to a marking ring or a marking protrusion or a marking line arranged on the outer peripheral wall of the sliding handle 5; when the sliding position mark 501 is at a distance from the proximal (rear end) end face of the sliding handle 5, the entire sliding handle 5 or at least the portion corresponding to the proximal (rear end) side of the sliding position mark 501 is made of a transparent or translucent material for the operator to observe, or the proximal end face edge of the sliding handle 5 can also be used as the above-mentioned sliding position mark 501.
  • the outer tube assembly 200 includes, in addition to the outer tube 3 and the expansion and contraction portion 4, a sealing device 52, and the sealing device 52 is configured to be able to radially seal the tube gap between the proximal inner wall of the outer tube 3 and the outer wall of the inner tube 1; specifically, the specific setting method of the sealing device 52 includes but is not limited to: regardless of whether the above-mentioned sliding handle 5 is provided, the setting position of the sealing device 52 is located in the tube gap between the proximal inner wall of the outer tube 3 and the outer wall of the inner tube 1, thereby directly sealing the gap between the proximal inner wall of the outer tube 3 and the outer wall of the inner tube 1 along the radial direction, or, as shown in Figure 13, the above-mentioned sliding handle 5 is provided, and the setting position of the sealing device 52 is located between the inner wall of the sliding handle 5 and the outer wall of the inner tube 1, so as to seal the gap between the inner
  • sealing device 52 can be, but is not limited to, a sealing ring structure as shown in Figure 13, or it can be an annular rear cover (not shown) provided at the proximal end (rear end) of the outer tube 3 or the proximal end (rear end) of the sliding handle 5.
  • thrombolytic agents such as streptokinase and urokinase are allowed to enter the interior of the thrombus, which can significantly accelerate the rate of thrombus dissolution.
  • a handle liquid hole 51 is further provided on the sliding handle 5, and the handle liquid hole 51 is connected to the gap between the outer tube 3 and the inner tube 1; and the handle liquid hole 51 is located on the distal side of the sealing device 52; or, in other preferred embodiments of the present embodiment, regardless of whether the above-mentioned sliding handle 5 is provided or not, as shown in FIG22, an outer tube liquid hole 32 is provided on the proximal wall of the outer tube 3, which passes through the tube wall of the outer tube 3; when both the outer tube liquid hole 32 and the above-mentioned sealing device 52 are provided, the above-mentioned outer tube liquid hole 32 is located on the distal side of the sealing device 52.
  • thrombolytic drugs by injecting thrombolytic drugs into the handle liquid hole 51 or the outer tube liquid hole 32, ultrasonic energy can accelerate the penetration speed of thrombolytic drugs into the thrombus, greatly improve the dissolution efficiency of thrombus, and then effectively reduce the volume and expand the lumen, reduce the proportion of stent implantation, and improve the short-term and medium-term treatment effects.
  • the injected thrombolytic drugs can flow out from the distal tube mouth of the outer tube 3, or as shown in Figures 14 to 16, a spray hole 31 is set on the distal side wall of the outer tube 3 so that the thrombolytic drugs can be sprayed from the side of the outer tube 3 and better contact with the blood vessel wall.
  • the handle liquid hole 51 or the outer tube liquid hole 32 can also be used to inject contrast agents and other diagnostic and therapeutic liquids.
  • the lumen opening device by setting the above-mentioned handle liquid hole 51 or the outer tube liquid hole 32, the lumen opening device also has the function of a thrombolytic catheter, avoiding the step of separately inserting a thrombolytic catheter to inject thrombolytic liquid, thereby further improving the efficiency of the operation.
  • liquid can be injected into the inner tube 1 through the proximal end of the inner tube 1 to cool the inner tube 1 and the outer tube 3 to ensure that the temperature of the surgical environment is not too high.
  • its structure can be, as shown in FIG. 22, an inner tube liquid through hole 103 penetrating the tube wall of the inner tube 1 is provided on the proximal end wall of the inner tube 1, and liquid is injected through the inner tube liquid through hole 103.
  • the ultrasonic connector assembly 2 includes an ultrasonic connector 21, and the proximal end of the ultrasonic connector 21 is provided with a connecting portion 210 configured to be connected to the ultrasonic transducer 7; the ultrasonic connector 21 is provided with an inner tube connecting hole 211 and a connector liquid through hole 212, The proximal end of the inner tube 1 is connected to the distal end of the inner tube connecting hole 211 and the lumen of the inner tube 1 is connected to the inner tube connecting hole 211.
  • the connecting head liquid hole 212 is connected to the inner tube connecting hole 211. Liquid is injected through the connecting head liquid hole 212 to cool the inner tube 1 and the outer tube 3.
  • a negative pressure device can also be connected through the connecting head liquid hole 212 to form a negative pressure inside the inner tube 1, thereby sucking out debris generated when the thrombus site is opened or during the thrombolysis process.
  • the ultrasonic joint assembly 2 also includes a hose 22 and a one-way valve assembly 23; one end of the hose 22 is connected to the connector liquid hole 212, and a portion of the hose 22 away from the connector liquid hole 212 is connected to a one-way valve assembly 23 that only allows liquid to flow from the hose 22 through the connector liquid hole 212 into the inner tube connecting hole 211; when the ultrasound is working, liquid is injected into the connector liquid hole 212 through the hose 22 and the one-way valve assembly 23.
  • the outer tube liquid hole 32, the handle liquid hole 51, the inner tube liquid hole 103 and the above-mentioned connecting head liquid hole 212 are not limited to the type of injection liquid.
  • the outer tube liquid hole 32 and the handle liquid hole 51 can also be used for injection of ultrasonic cooling liquid
  • the inner tube liquid hole 103 and the connecting head liquid hole 212 can also be used for injection of thrombolytic drugs or contrast agents and other diagnostic and therapeutic liquids
  • the outer tube liquid hole 32, the handle liquid hole 51, the inner tube liquid hole 103 and the above-mentioned connecting head liquid hole 212 can be selectively set at the same time or one by one or in any combination.
  • the lumen opening system includes an ultrasonic generator 6, an ultrasonic transducer 7, and a lumen opening device provided by any optional implementation scheme in Example 1, the ultrasonic transducer 7 is connected to the ultrasonic generator 6, the ultrasonic connector assembly 2 is connected to the ultrasonic transducer 7, and the ultrasonic generator 6 can be driven, but not limited to, by a foot-driven pedal 8 as shown in FIG15 .
  • the embodiment of the present disclosure also provides a lumen opening method, which uses the lumen opening system provided by the second aspect above to deliver the distal end of the lumen opening device into the occluded part of the patient's blood vessel cavity, start the ultrasonic generator 6, and drive the inner tube 1 to vibrate. While the inner tube 1 is ultrasonically vibrating, the ultrasonic energy of the inner tube 1 can be transmitted to the expansion and contraction part 4 connected to the distal end of the outer tube 2, so that the expansion and contraction part 4 in the expanded state can cut the thrombus.
  • the lumen opening method provided in the embodiment of the present disclosure applies the aforementioned lumen opening system, and the lumen opening system includes the aforementioned lumen opening device, the lumen opening method and lumen opening system provided in the embodiment of the present disclosure can achieve all the beneficial effects that the aforementioned lumen opening device can achieve.
  • the lumen opening device, lumen opening system and lumen opening method provided in the embodiments of the present disclosure are not limited to use in surgical scenarios for opening blood vessels.
  • the lumen opening device and lumen opening system can also be used in other human lumens such as ureters and bile ducts.
  • the embodiments of the present disclosure provide a lumen opening device, a lumen opening system and a lumen opening method, which at least alleviate the problems in the existing intracavitary interventional treatment of occlusive lesions, such as the difficulty of the device to pass through the occluded segment of the lesion, the cumbersome operation of the device, the poor effect of balloon dilatation and volume reduction, the need for stent placement, and the low long-term patency rate caused by restenosis in the stent. It improves the immediate success rate of the operation and the medium- and long-term effects, and has industrial applicability.

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Abstract

一种管腔开通器械、管腔开通系统及管腔开通方法，管腔开通器械包括内层管组件（100）和外层管组件（200）；内层管组件（100）包括内管（1）和连接于内管（1）近端的超声接头组件（2）；外层管组件（200）包括外管（3）和连接于外管（3）远端的至少一个扩缩部（4）；外管（3）和这些扩缩部（4）均套装于内管（1）外部；外层管组件（200）能够相对内管（1）运动，以使扩缩部（4）在扩张状态和收缩状态之间相互转变。

Description

管腔开通器械、管腔开通系统及管腔开通方法
相关申请的交叉引用
本公开要求于2022年12月02日提交中国专利局的申请号为2022115330901、名称为“管腔开通器械和管腔开通系统”的中国专利申请的优先权，其全部内容通过引用结合在本公开中。
技术领域
本公开涉及医疗器械的技术领域，尤其是涉及一种管腔开通器械、管腔开通系统及管腔开通方法。
背景技术
腔内介入治疗因微创成为当前很多疾病治疗的首选方式，常用的腔内介入治疗的器具包括导丝、球囊，支架，减容设备等等，现有技术中，治疗过程至少包括：第一，将导丝通过穿刺口沿人体管腔推送到病变部位，为了避免推送过程损伤管腔，引导导丝的头端一般比较柔软，导丝到达病变部位后，无法直接通过病变，需要置入导管后，通过导管交换通过性好的导丝穿过病变；对于一些闭塞性病变来说，闭塞段伴有坚硬的纤维帽、钙化斑，质地较硬，存在导丝过程耗时长、损伤管壁、开通成功率低的问题；第二，沿导丝推入球囊导管，进一步扩大闭塞段的内腔尺寸，因为球囊无法做到真正的减容，管腔回缩导致扩张效果不佳；第三，效果不佳时需置入支架扩张管腔，但是支架置入后会刺激内皮增生，导致支架内再狭窄，中远期闭塞率非常高。以上整个过程需要变换使用开通和扩张器械，操作繁琐、手术时间长。开通失败、扩张效果不佳、支架再狭窄是目前腔内介入治疗手术亟待解决的问题。
此外，需要了解的现有技术还包括：已知的超声能量传输系统包括发生器、换能器组件(超声手柄)以及导管或导丝，发生器配置为生成、控制、放大和/或传递期望频率的交变电子信号(例如，电压信号)至换能器组件；换能器组件(超声手柄)通常地包括一个或者多个压电陶瓷，该压电陶瓷在由高频电子信号激励时以高频扩张和收缩；这些高频振动被变幅杆放大成超声能量，该超声能量被传输至导管或导丝；超声能量被传输到导管或导丝的远端以消融和/或以其它方式破坏身体病变。
申请内容
本公开的目的包括提供一种管腔开通器械、管腔开通系统及管腔开通方法，缓解了现有闭塞性病变腔内介入治疗手术中，器械难以穿过病变闭塞段的问题、变换使用开通和扩张器械导致的操作繁琐问题、以及球囊扩张减容效果不佳需置入支架，支架内再狭窄导致远期通畅率低的问题，提高了手术即刻成功率和中远期效果。
为实现上述目的，本公开实施例采用如下技术方案：
第一方面，本公开实施例提供一种管腔开通器械，该管腔开通器械包括内层管组件和外层管组 件；具体地，所述内层管组件包括内管和连接于所述内管的近端的超声接头组件；所述外层管组件包括外管和连接于所述外管的远端的至少一个扩缩部。所述外管和所述至少一个扩缩部均套装于所述内管的外部；所述扩缩部配置成具有整体贴合或贴近所述内管外壁的收缩状态以及沿所述内管径向朝所述内管的外部膨起的扩张状态，所述外层管组件能够相对所述内管运动，以使所述扩缩部在所述扩张状态和所述收缩状态之间相互转变。
本实施例提供的管腔开通器械的使用方式及其至少能够达到的功能效果如下：
使用时要使用到超声设备，超声设备一般包括相互连接的超声发生器和超声换能器，一些超声设备还包括脚驱动踏板，超声发生器可通过脚驱动踏板进行驱动，配合启动超声设备，还有一些其他驱动方式的超声设备，均为现有技术，本公开不再赘述。
将内管近端的超声接头组件与超声设备的超声换能器进行连接，并确保各扩缩部均处于收缩状态，再将该管腔开通器械的内管远端伸入到病变闭塞处；然后：
第一步，启动超声设备，借助超声能量对闭塞处进行开通，该开通方式主要是应用了机械振动和空化的组合机制，借助超声能量进行管腔开通，超声频率的机械振动沿开通器械至病变位置，器械高频振动时会产生空化作用，在病变周围产生微小的气泡，这些微小的气泡会在交替周期的振动波中振荡，气泡会被交替性地拉伸和压缩，在气泡被压缩至崩溃的瞬间，会产生瞬时压力，这种瞬时的压强跳跃形成激波，无数气泡爆破就如同无数的微炸弹，对闭塞段内部结构造成破坏，可以让器械快速通过病变位置的同时扩大管腔；更具体地，超声所产生的高频低幅机械振动可使内管远端像振动“手提锤”一样打通坚硬的纤维帽，内管的高频振动在周围流体中产生强烈的负压和正压循环，当内管远端缩回时，在压力循环的负侧溶解气体会形成空化气泡，气泡在压力循环的正侧迅速破裂，空化气泡的破裂会产生强烈的机械冲击波，侵蚀钙化斑块；同时，治疗性超声的闭塞段再通，还具有斑块消融选择性的特点，胶原蛋白和弹性蛋白含量高的组织对超声波破坏具有极强的抵抗力，然而，缺乏这些成分的组织很容易受到破坏，高强度超声波破坏纤维状或钙化斑块，但是不会损伤正常的动脉血管，该闭塞段开通方式效率更高，有利于大大缩短手术时的闭塞段开通时间，且避免了闭塞段过硬，导丝不能穿过的问题，提高了闭塞段开通成功率；
第二步，操作外层管组件，使外层管组件相对内管运动，从而使各扩缩部从收缩状态转变为扩张状态，从而，对第一步开通出的孔进行扩大，以进一步扩大闭塞段的内腔尺寸，同时对内管进行支撑，间接提高对内管内伸入的导丝进行支撑的支撑力，导丝在该强支撑力的作用下，可以有很强的方向性，不容易弯折，进而进一步缩短了闭塞段开通时间、提高了闭塞段开通效率；
特别地，上述第一步和第二步也可以相反顺序进行，即，先操作外层管组件，使外层管组件相对内管运动，从而使各扩缩部从收缩状态转变为扩张状态，扩张状态的扩缩部对内管进行支撑，然后再启动超声设备，借助超声能量对闭塞处进行开通，优选地，上述第一步和第二步根据术者需要交替进行。
综上，本实施例提供的管腔开通器械缓解了现有闭塞性病变腔内介入治疗手术中，器械难以穿过病变闭塞段的问题，达到了很好的缩短闭塞段开通时间、提高闭塞段开通效率的效果，同时，根 据以上分析可知，整个对病变闭塞段进行开通和扩张过程中并未更换手术器械，进而，缓解了现有闭塞性病变腔内介入治疗手术中，变换使用开通和扩张器械导致的操作繁琐问题、以及球囊扩张效果减容不佳需置入支架，支架内再狭窄导致远期通畅率低的问题，相比于现有技术而言，本实施例提供的管腔开通器械使用起来更加简单方便、手术过程更加快速、便捷，有利于更进一步提高手术效率，降低手术时间过长导致各种并发症的手术风险、进一步提高了手术即刻成功率和中远期效果(需要注意的是：本公开提供的管腔开通器械能够达到的效果，仅仅是相对于现有技术提供的管腔开通器械以及大多数病患情况而言的，由于实际手术治疗时，手术影响因素较多，因而，这并不意味着，使用本公开提供的管腔开通器械就能保证对任何相关疾病患者治疗的绝对安全有效)。
在本公开实施例的一些较为优选的实施方式中，所述内管的远端伸出于所述至少一个扩缩部中最靠近所述内管的远端的部位。在进一步优选的实施方式中，所述内管的远端伸出于所述至少一个扩缩部中最靠近所述内管的远端的部位。
以最靠近所述内管的远端的扩缩部为远端扩缩部：在本公开实施例的一些可选实施方式中，所述扩缩部仅包括远端扩缩部即，扩缩部有且只有一个；在本公开实施例的另一些可选实施方式中，所述扩缩部具有至少两个，且以最远离所述内管的远端的扩缩部为近端扩缩部，其中：所述至少两个扩缩部首尾依次连接，所述外管的远端连接于所述近端扩缩部的近端；或者，所述外管包括近端管和多段远端管，所述至少两个扩缩部两两间隔，且相邻两个所述扩缩部之间通过至少一段所述远端管相连接，所述近端管的远端连接于所述近端扩缩部的近端。
在本公开实施例的一些可选实施方式中，所述至少一个扩缩部中，最靠近所述内管的远端的部位固定于所述内管的远端外壁。在这些可选实施方式中，进一步可选地，所述外管能够相对所述内管转动，以使所述扩缩部在所述扩张状态和所述收缩状态之间相互转变；或者，进一步可选地，所述外管能够相对所述内管前后滑动，以使所述扩缩部在所述扩张状态和所述收缩状态之间相互转变。
在本公开实施例的另一些可选实施方式中，所述内管的远端外壁设限位结构，所述至少一个扩缩部中最靠近所述内管的远端的部位，被所述限位结构限位于所述内管的远端外壁。
优选地，所述远端扩缩部的远端还连接有约束固定部件，该约束固定部件作为上述一些实施方式中与内管远端外壁固定连接的部位，或作为上述另一些实施方式中，被限位部件限位的部位。进一步可选地，该约束固定部件包括固定环或固定管，所述固定环或固定管套装于所述内管外部。；
在一些可选实施方式中，所述内管的远端外壁设上述限位结构，所述远端扩缩部的远端连接有上述约束固定部件，约束固定部件被限位结构限位于内管的远端外壁，所述外管能够相对所述内管前后滑动，以使所述扩缩部在所述扩张状态和所述收缩状态之间相互转变，此时，上述提到的所述内管的远端外壁上的限位结构包括远端阻挡凸起，所述远端扩缩部的约束固定部件被阻挡于所述远端阻挡凸起的近端侧，较佳地但不限于，所述限位结构还包括近端阻挡凸起，所述近端阻挡凸起位于所述远端扩缩部的约束固定部件的近端侧。
在本公开实施例的一些可选实施方式中，所述外层管组件还包括外鞘管，所述外鞘管套装于所述外管的外部，所述外鞘管能够相对所述外管前后滑动，以将所述扩缩部收拢或释放于所述外鞘管 的内壁与所述外管的外壁之间的间隙。
在本公开实施例的可选实施方式中，较佳地但不限于，所述扩缩部包括骨架，所述骨架呈网格状或由多根沿所述内管的轴向延伸的连接丝间隔排列而成。进一步地，较为优选地但不限于，所述扩缩部还包括连接于所述骨架的覆膜，所述覆膜由柔性材料制成。在本公开实施例的一些可选实施方式中，所述外层管组件还包括密封装置，所述密封装置配置成能够沿径向密封所述外管的近端内壁和所述内管的外壁之间的管间隙。
进一步可选地，外层管组件还包括滑动手柄，所述滑动手柄连接于所述外管的近端且套装于所述内管外部，并且，所述滑动手柄配置成能够带动所述外管相对所述内管前后滑动。
可选地，所述密封装置的设置位置位于所述滑动手柄的内壁和所述内管的外壁之间，以沿径向密封所述滑动手柄的内壁和所述内管的外壁之间的间隙，进而间接沿径向密封所述外管的近端内壁和所述内管的外壁之间的间隙。
一种可选实施方式中，在所述滑动手柄上设有手柄通液孔，所述手柄通液孔与所述外管和所述内管之间的间隙连通；且所述手柄通液孔位于所述密封装置的远端侧。
另一可选实施方式中，所述密封装置设于所述外管的近端内壁和所述内管的外壁之间的管间隙中，进而直接沿径向密封所述外管的近端内壁和所述内管的外壁之间的间隙。
可选地，所述滑动手柄上设有滑动位置标记，所述内管的近端外壁设有沿所述内管的轴向设置的刻度线，所述滑动位置标记与所述刻度线相互配合以显示所述外管相对所述内管前后滑动的距离。
本公开实施例的可选实施方式中，所述外管的近端壁上设有贯通所述外管的管壁的外管通液孔。
本公开实施例的可选实施方式中，所述内管的近端壁上设有贯通所述内管的管壁的内管通液孔。
在本实施例的上述任一可选实施方式中，较为优选地，所述超声接头组件包括超声连接头；所述超声连接头的近端设有配置成能与超声换能器连接的连接部；所述超声连接头上设有内管连接孔和连接头通液孔，所述内管的近端连接于所述内管连接孔的远端且所述内管的管腔与所述内管连接孔连通，所述连接头通液孔与所述内管连接孔连通。
进一步优选地，所述超声接头组件还包括软管和单向阀组件；所述软管的一端连接于所述连接头通液孔，所述软管远离所述连接头通液孔的部位连接有仅允许液体自所述软管经由所述连接头通液孔流入所述内管连接孔的单向阀组件。
第二方面，本公开实施例提供一种管腔开通系统，包括超声发生器、超声换能器以及前述实施方式中任一项所述的管腔开通器械，所述超声换能器与所述超声发生器连接，所述超声接头组件与所述超声换能器连接。
第三方面，本公开实施例还提供一种管腔开通方法，该管腔开通方法使用前述第二方面所述管腔开通系统，将所述管腔开通器械的远端送入患者血管腔内闭塞处，启动所述超声发生器，带动所述内管振动，在所述内管超声振动的同时，所述内管的超声能量能够传递到连接于所述外管远端的扩缩部，以使处于扩张状态下的所述扩缩部切割血栓。
由于本公开实施例提供的管腔开通方法应用前述管腔开通系统，管腔开通系统又包括前述管腔 开通器械，因而，本公开实施例提供的管腔开通方法和管腔开通系统能够达到前述管腔开通器械能够达到的所有有益效果。
附图说明
为了更清楚地说明本公开具体实施方式或现有技术中的技术方案，下面将对具体实施方式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，下面描述中的附图是本公开的一些实施方式，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的附图。
图1为本公开实施例提供的管腔开通器械，在扩缩部处于扩张状态下的整体结构示意图；
图2为图1中A部位的局部结构放大图；
图3为本公开实施例提供的管腔开通器械，在扩缩部处于收缩状态下的整体结构示意图；
图4为图3中A＇部位的局部结构放大图；
图5为本公开实施例提供的管腔开通器械中，扩缩部的第一种可选结构示意图；
图6为本公开实施例提供的管腔开通器械中，扩缩部的第二种可选结构示意图；
图7为本公开实施例提供的管腔开通器械中，扩缩部的第三种可选结构示意图；
图8为本公开实施例提供的管腔开通器械中，扩缩部的第四种可选结构示意图；
图9为本公开实施例提供的管腔开通器械中，远端扩缩部的远端与内管之间一种连接结构的扩张状态示意图；
图10为图9示出的远端扩缩部的远端与内管之间连接结构的收缩状态示意图；
图11为本公开实施例提供的管腔开通器械中，远端扩缩部的远端与内管之间另一种连接结构的扩张状态示意图；
图12为图11示出的远端扩缩部的远端与内管之间连接结构的收缩状态示意图；
图13为本公开实施例提供的管腔开通器械的一些可选实施方式中，滑动手柄的整体结构剖视图；
图14为本公开实施例提供的管腔开通器械的一些可选实施方式中，超声连接头的整体结构剖视图；
图15为本公开实施例提供的管腔开通系统的整体结构示意图；
图16为应用本公开实施例提供的管腔开通器械或管腔开通系统进行手术治疗时，导管远端开通阶段示意图；
图17为应用本公开实施例提供的管腔开通器械或管腔开通系统进行手术治疗时，扩缩段进入闭塞段的阶段示意图；
图18为应用本公开实施例提供的管腔开通器械或管腔开通系统进行手术治疗时，扩缩段扩张阶段示意图；
图19为本公开实施例提供的管腔开通器械中，外层管组件包括外鞘管时，外鞘管与外管、内管之间的远端装配结构示意图；
图20为本公开实施例提供的管腔开通器械中，滑动手柄上滑动位置标记与内管上刻度线的配合结构示意图；
图21为一些实施例中，内管远端的尖端结构示意图；
图22为一些实施例中，外管近端设外管通液孔、内管近端设内管通液孔的管层结构局部示意图。
图标：1-内管；101-尖端；102-刻度线；103-内管通液孔；11-限位结构；111-远端阻挡凸起；112-近端阻挡凸起；2-超声接头组件；21-超声连接头；210-连接部；211-内管连接孔；212-连接头通液孔；22-软管；23-单向阀组件；3-外管；31-喷液孔；32-外管通液孔；4-扩缩部；41-骨架；42-约束固定部件；5-滑动手柄；501-滑动位置标记；51-手柄通液孔；52-密封装置；6-超声发生器；7-超声换能器；8-脚驱动踏板；9-外鞘管。
具体实施方式
为使本公开实施例的目的、技术方案和优点更加清楚，下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本公开一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本公开实施例的组件可以各种不同的配置来布置和设计。
因此，以下对在附图中提供的本公开的实施例的详细描述并非旨在限制要求保护的本公开的范围，而是仅仅表示本公开的选定实施例。基于本公开中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本公开保护的范围。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本公开的描述中，需要说明的是，术语“上”、“下”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，或者是该发明产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本公开和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本公开的限制。此外，术语“第一”、“第二”、“第三”等仅配置成区分描述，而不能理解为指示或暗示相对重要性。
在本公开的描述中，还需要说明的是，除非另有明确的规定和限定，术语“设置”、“安装”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本公开中的具体含义。
特别地，本公开中，以手术时，医疗器械靠近术者的一端为该医疗器械的近端，以医疗器械进入患者血管的一端为该医疗器械的远端(医疗器械的前端为远端，医疗器械的后端为近端)，轴向，指平行或基本平行于医疗器械远端中心和近端中心连线的方向；径向，指垂直或基本垂直于上述轴向的方向。
下面结合附图，对本公开的一些实施方式作详细说明。在不冲突的情况下，下述的实施例及实 施例中的特征可以相互组合。
腔内介入治疗为当前动脉粥样硬化引发的闭塞性病变首选的治疗方式，常用的腔内介入治疗的器具包括导丝、球囊，支架，减容设备等等，现有技术中，治疗过程至少包括：第一，将导丝通过穿刺口沿人体管腔推送到病变部位，为了避免推送过程损伤血管，引导导丝的头端一般比较柔软，导丝到达病变部位后，无法直接利用引导导丝远端(前端)部分对病变处闭塞段进行开通，需要置入导管后，通过导管交换不同类型的导丝，直至导丝能够穿过闭塞病变；第二，导丝推入球囊导管、溶栓导管或者其他旋磨类的减容器械进一步扩大闭塞段的内腔尺寸，还可以但不限于包括植入支架行支架成形术。整个过程需要变换使用开通和扩张器械，操作繁琐、手术时间长，且对于第一步来说，由于由动脉粥样硬化引发的闭塞性病变，闭塞段伴有坚硬的纤维帽、钙化斑，质地较硬，存在导丝开通过程耗时长、损伤血管壁、开通成功率低的问题，闭塞段开通失败是目前造成闭塞性病变腔内介入治疗手术失败的主要问题之一。对于第二步来说，因为球囊无法做到真正的减容，血管回缩导致扩张效果不佳，甚至会导致血栓脱落、血管破裂，为了解决这些问题，又开发出了振波球囊、溶栓导管、旋磨导管、抽吸导管等减容装置，目的是为了去除血栓和钙化，提供更大的有效的管腔直径；减容效果不佳时需置入支架扩张管腔，但是支架置入后会刺激内皮增生，导致支架内再狭窄，中远期闭塞率非常高。
相对于此，本实施例提供一种管腔开通器械，参照图1至图4，该管腔开通器械包括内层管组件100和外层管组件200。
具体地，该内层管组件100包括内管1和超声接头组件2，该超声接头组件2连接于连接于内管1近端；该外层管组件200包括外管3和连接于外管3远端的至少一个扩缩部4。其中：外管3和这些扩缩部4均套装于内管1的外部，各扩缩部4均配置成具有如图3和图4所示的整体贴合或贴近内管1外壁的收缩状态，以及如图1和图2所示的沿内管1径向朝内管1外部膨起的扩张状态；其中，外层管组件200能够相对内管1运动，以使上述扩缩部4在这两个状态之间相互转变。
本实施例中，上述内管1和外管3由刚性或半刚性材料制成，例如但不限于，内管1和外管3采用金属管或金属编织复合管。
本实施例提供的管腔开通器械的使用方式及其至少能够达到的功能效果如下：
使用时要使用到超声设备，超声设备一般如图15所示，包括相互连接的超声发生器6和超声换能器7，一些超声设备还包括图15所示的脚驱动踏板8，超声发生器6可通过脚驱动踏板8进行驱动，配合启动超声设备，还有一些其他驱动方式的超声设备，均为现有技术，本公开不再赘述。
参照图1至图4以及图15至图18，将内管1近端的超声接头组件2与超声设备的超声换能器7进行连接，并确保各扩缩部4均处于收缩状态，再将该管腔开通器械的内管1远端伸入到病变闭塞处；然后：
第一步，启动超声设备，借助超声能量对闭塞处进行开通。该开通方式主要是应用了机械振动和空化的组合机制，借助超声能量进行管腔开通，超声频率的机械振动沿开通器械至病变位置，器械高频振动时会产生空化作用，在病变周围产生微小的气泡，这些微小的气泡会在交替周期的振动 波中振荡，气泡会被交替性地拉伸和压缩，在气泡被压缩至崩溃的瞬间，会产生瞬时压力，这种瞬时的压强跳跃形成激波，无数气泡爆破就如同无数的微炸弹，对闭塞段内部结构造成破坏，可以让器械快速通过病变位置的同时扩大管腔。更具体地，超声所产生的高频低幅机械振动可使内管1远端像振动“手提锤”一样打通坚硬的纤维帽，内管1的高频振动在周围流体中产生强烈的负压和正压循环，当内管1远端缩回时，在压力循环的负侧溶解气体会形成空化气泡，气泡在压力循环的正侧迅速破裂，空化气泡的破裂会产生强烈的机械冲击波，侵蚀钙化斑块；同时，治疗性超声的闭塞段再通，还具有斑块消融选择性的特点，胶原蛋白和弹性蛋白含量高的组织对超声波破坏具有极强的抵抗力，然而，缺乏这些成分的组织很容易受到破坏，高强度超声波破坏纤维状或钙化斑块，但是不会损伤正常的动脉血管，该闭塞段开通方式效率更高，有利于大大缩短手术时的闭塞段开通时间，且避免了闭塞段过硬，导丝不能穿过的问题，提高了闭塞段开通成功率；
第二步，操作外层管组件200，使外层管组件200相对内管1运动，从而使各扩缩部4从图3和图4所示的收缩状态转变为图1和图2所示的扩张状态，从而，对第一步开通出的孔进行扩大，以进一步扩大闭塞段的内腔尺寸，同时对内管1进行支撑，间接提高对内管1内伸入的导丝(导丝为介入手术用的常规引导丝，本公开未图示出)进行支撑的支撑力，导丝在该强支撑力的作用下，可以有很强的方向性，不容易弯折，进而进一步缩短了闭塞段开通时间、提高了闭塞段开通效率；
特别地，上述第一步和第二步也可以相反顺序进行，即，先操作外层管组件200，使外层管组件200相对内管1运动，从而使各扩缩部4从图3和图4所示收缩状态转变为图1和图2所示扩张状态，扩张状态的扩缩部4对内管1进行支撑，然后再启动超声设备，借助超声能量对闭塞处进行开通，优选地，上述第一步和第二步根据术者需要交替进行。
综上，本实施例提供的管腔开通器械缓解了现有闭塞性病变腔内介入治疗手术中，器械难以穿过病变闭塞段的问题，达到了很好的缩短闭塞段开通时间、提高闭塞段开通效率的效果，同时，根据以上分析可知，整个对病变闭塞段进行开通和扩张过程中并未更换手术器械，进而，缓解了现有闭塞性病变腔内介入治疗手术中，变换使用开通和扩张器械导致的操作繁琐问题、以及球囊扩张效果减容不佳需置入支架，支架内再狭窄导致远期通畅率低的问题，相比于现有技术而言，本实施例提供的管腔开通器械使用起来更加简单方便、手术过程更加快速、便捷，有利于更进一步提高手术效率，降低手术时间过长导致各种并发症的手术风险、进一步提高了手术即刻成功率和中远期效果(需要注意的是：本公开提供的管腔开通器械能够达到的效果，仅仅是相对于现有技术提供的管腔开通器械以及大多数病患情况而言的，由于实际手术治疗时，手术影响因素较多，因而，这并不意味着，使用本公开提供的管腔开通器械就能保证对任何相关疾病患者治疗的绝对安全有效)。
如图21所示，本实施例中，优选地但不限于，内管1的远端部位设有尖端101，该尖端101可以是卡接、螺纹连接等可拆卸连接或固定连接或一体连接在内管1远端部位的圆锥状空心导向头，也可以是沿内管1的近端指向远端的方向，内管1的管壁厚度在远端部位逐渐变薄形成的尖锐结构。特别地，本实施例中，内层管组件100和外层管组件200还可以包括更多管结构，与图1至图4所示内管1和外管3配合套装，以满足其他功能需要，但是，本实施例最基础的结构中，内层管组件 100至少包括图1至图4所示的内管1，外层管组件200至少包括上述的外管3。
下面对本实施例提供的管腔开通器械的具体结构进行更加详细的说明：
具体地，本实施例中，内管1的远端可以如图1至图4所示，伸出于这些扩缩部4中最靠近内管1远端的部位，还可以是，内管1的远端面平齐于扩缩部4的远端面，或者，内管1的远端位于扩缩部4的内部，其中，较为优选地，如图1至图4所示，使内管1的远端伸出于这些扩缩部4中最靠近内管1远端的部位，以使超声开通过程中，内管1远端不被扩缩部4干扰而与闭塞部位充分接触，保证超声开通时内管1的远端快速开通病变闭塞段。
继续参照图1至图4，本实施例中，以最靠近内管1远端的扩缩部4作为远端扩缩部：在一些可选实施方式中，扩缩部4仅包括远端扩缩部，即，扩缩部4有且只有一个。在另一些可选实施方式中，扩缩部4则具有至少两个，且以这些扩缩部4中，最远离内管1远端的扩缩部4作为近端扩缩部，其中：这些扩缩部4首尾依次连接，外管3的远端连接于近端扩缩部的近端；或者，外管3包括近端管和多段远端管，这些扩缩部4两两间隔，且相邻两个扩缩部4之间通过至少一段远端管相连接，近端管的远端连接于近端扩缩部的近端。
对于外管3相对内管1运动以使扩缩部4在，图1和图2所示扩张状态、图3和图4所示收缩状态这两个状态之间相互转变的具体转变方式，至少包括以下两大类可选方式：
第一大类可选方式，在这些扩缩部4中：最靠近内管1远端的部位固定于内管1的远端外壁，或者，如图2和图4所示，内管1的远端外壁设限位结构11，最靠近内管1远端的部位被该限位结构11限位于内管1的远端外壁，外管3通过相对内管1转动或前后滑动，进而控制扩缩部4的状态转变；
具体地，参照图1至图12，扩缩部4包括骨架41，该骨架41呈网格状或由多根沿内管1轴向延伸的连接丝间隔排列而成。
以外管3通过相对内管1转动，进而控制扩缩部4的状态转变为例，需使这些扩缩部4中，最靠近内管1远端的部位固定于内管1的远端外壁；使扩缩部4自由状态为扩张状态且具有一定回弹力，收缩状态下，扩缩部4可缠绕于内管1外周壁，相对内管1转动可释放扩缩部4，以使扩缩部4恢复扩张状态；
以外管3通过相对内管1前后滑动，进而控制扩缩部4的状态转变为例，使最靠近内管1远端的部位固定于内管1的远端外壁，或者，如图2和图4所示，内管1的远端外壁设限位结构11，最靠近内管1远端的部位被该限位结构11限位于内管1的远端外壁；使扩缩部4自由状态为扩张状态且具有一定回弹力，收缩状态下，外管3可向近端方向拉直扩缩部4，相对内管1向前推动扩缩部4可释放扩缩部4，以使扩缩部4恢复扩张状态，也可以使扩缩部4自由状态为收缩状态，由于这些扩缩部4中最靠近内管1远端的部位固定于内管1的远端外壁，或被设于内管1远端外壁上的限位结构11限位于内管1的远端外壁，从而，当相对内管1向远端方向推动外管3，即可对扩缩部4进行轴向压缩，进而，使扩缩部4转变为扩张状态。
在以上结构中，由于连接于外管3远端的扩缩部4最靠近内管1远端的部位固定于内管1远端 外管壁，或被限位结构11限位于内管1远端外管壁，即，连接于外管3远端的扩缩部4与内管1远端固定在一起(有接触)，从而，在内管1超声振动的同时，内管1的超声能量可传递到连接于外管3远端的扩缩部4，加上外层管组件200相对内管1运动，可使各扩缩部4从收缩状态转变为扩张状态，扩张状态的扩缩部4就可以切割血栓，贴近血管壁，击碎附壁钙化斑，进而进一步缩短闭塞段开通时间、提高闭塞段开通效率。
上述外管3相对内管1前后滑动和相对转动两控制形式中，进一步优选外管3能够相对内管1前后滑动的控制形式，以使扩缩部4在扩张状态和收缩状态之间相互转变，且扩缩部4优选采用上述的自由状态为收缩状态的结构。这种结构，可通过对外管3相对于内管1的推拉程度，对扩缩部4的扩张状态的膨起度进行调整，以使该扩缩部4适应于多种直径的血壁或闭塞段开孔，有利于超声能量从内管1经由扩缩部4更好地传递到血栓和血壁，更具体地，在外管3相对内管1朝向远端方向滑动的情况下，扩缩部4自收缩状态向扩张状态转变，在外管3相对内管1朝向近端方向滑动的情况下，扩缩部4自扩张状态向收缩状态转变。
第二大类可选方式，则如图19所示，使外层管组件200还包括外鞘管9，该外鞘管9套装于外管3外部，外鞘管9能够相对外管3前后滑动，以将所述扩缩部4收拢或释放于外鞘管9内壁与外管3外壁之间的间隙，进而控制扩缩部4的状态转变。具体地，使扩缩部4自由状态为扩张状态且具有一定回弹力，初始状态下，扩缩部4收拢在外鞘管9内壁与外管3外壁之间的间隙中，相对外管3后撤外鞘管9，扩缩部4可慢慢露出于外鞘管9远端，最终，扩缩部4释放于前述间隙，扩缩部4恢复扩张状态。
下面，结合图1至图12，对本实施例的扩缩部4的具体结构进行详细介绍：
参照图1至图12，扩缩部4包括骨架41，该骨架41可由直线、曲线、丝状、条状、网状或螺旋状或其他形状的连接线加工而成，该连接线可以但部限于采用金属材料或其他高性能非金属材料或复合材料，优选采用不锈钢、镍钛、钴基或钛基等金属材料进行制造；如图5和图8所示，骨架41呈网格状，或者，如图6所示，骨架41由多根沿内管1的轴向延伸的连接丝间隔排列而成，骨架41可由连接丝近端和远端分别约束而成，也可以是如图7所示，由一个整体管材切割而成并且中部做膨起状。
其中，以最靠近内管1的远端的扩缩部4为远端扩缩部，且在外管3能够相对内管1转动或前后滑动，以使扩缩部4在扩张状态和收缩状态之间相互转变的情况下：
如图9和图10所示，在一些可选实施方式中，远端扩缩部的骨架41的远端以一体连接或粘接或铆压或焊接或其他固定连接方式固定连接于内管1的远端外壁。
如图5、图6以及图8至图12所示，在一些可选实施方式中，远端扩缩部还包括连接于骨架41的远端的约束固定部件42，远端扩缩部的约束固定部件42可以固定于内管1的远端外壁，固定方式包括但不限于以一体连接或粘接或铆压或焊接或其他固定连接或者以卡接等方式进行固定，或者，约束固定部件42被限位结构11限位于内管1的远端外壁。继续参照图5、图6、以及图8至图12，在这些可选实施方式中，该约束固定部件42的结构包括固定环或固定管，该固定环或固定管套装于 内管1外部，且该约束固定部件42可以与骨架41一体成型而成或者单独焊接或以其他方式固定连接于骨架41。继续参照图11和图12，结合图1至图4，其中，在外管3能够相对内管1前后滑动，以使扩缩部4在扩张状态和收缩状态之间相互转变的情况下，较为优选地但不限于，如图11和图12所示，该限位结构11包括远端阻挡凸起111，远端扩缩部的约束固定部件42被阻挡于远端阻挡凸起111的近端侧，当相对内管1向远端方向推动外管3时，远端扩缩部的约束固定部件42与远端阻挡凸起111接触，远端阻挡凸起111阻挡远端扩缩部的约束固定部件42继续相对内管1向远端方向滑动，进而，扩缩部4被轴向压缩径向膨起至扩张状态，外管3相对内管1向近端方向滑动时，扩缩部4恢复原状；为进一步限定各扩缩部4的移动范围，提高操作精确度，较佳地但不限于，如图2、图4以及图11、图12所示，该限位结构11还包括近端阻挡凸起112，近端阻挡凸起112位于远端扩缩部的约束固定部件42的近端侧，近端阻挡凸起112与远端阻挡凸起111共同限位约束固定部件42。
此外，在本实施例的优选实施方式中，扩缩部4还包括连接于骨架41的覆膜，该覆膜由PU(聚氨酯)、尼龙、Pebax(尼龙弹性体)、PET(Polyethylene terephthalate，聚对苯二甲酸乙二醇酯)、PTFE(Poly tetra fluoroethylene，聚四氟乙烯)、PVF(polyvinyl-fluoride，聚氟乙烯；Polyvinylformal，聚乙烯醇缩甲醛)、FEP(Fluorinated ethylene propylene，氟化乙烯丙烯共聚物)、硅橡胶、PI(聚酰亚胺)等柔性材料制成，该覆膜配置成供涂覆溶栓药物或者如紫杉醇或雷帕霉素等抗内皮增生药物，在一些可选实施方式中，覆膜为未涂覆有药物的裸膜，在另一些可选实施方式中，覆膜上预先涂覆有药物。其中，覆膜可缝合或以涂覆、粘接、焊接、浸涂、喷涂等其他方式连接于骨架41，例如但不限于：提前制备能够成膜的溶液，溶液可由高分子聚合物可溶于有机溶剂的具有生物相容性的材料制成，将骨架41浸入该溶液并取出，由于骨架41尤其网格状骨架的连接线间隙小，溶液表面张力可形成液膜悬挂在骨架41的间隙处，待溶液挥发后留下高分子聚合物等材料形成薄膜后粘结在骨架41表面，由此形成覆膜，覆膜的厚度可以通过溶液浓度来控制或者涂覆的次数来控制，或者，通过激光焊接的方式，将通过挤出吹塑工艺将高分子材料加工的中空的球囊两个端部焊接到骨架41上得到覆膜等。通过药物涂敷、喷涂、浸渍等方法可将药物附在覆膜表面从而实现覆膜载药。本优选实施方式设置覆膜的目的，主要是为了增加扩缩部4在扩张状态下与病变血管壁的接触面积，以将颗粒药物或者药物层黏附于覆膜表面，扩缩部4扩张状态下撑开骨架41和覆膜，膜表面贴合病变处，通过直接贴附病变传递药物，与超声振动相互配合，使药物从膜表面脱落，并在超声振动作用下加速药物溶解，被病变组织吸收，对病变处做局部治疗。尤其对于如雷帕霉素，紫杉醇抗内皮增生药物，此类药物具有毒性，不宜大量使用，但是如不设覆膜，仅通过在骨架41上涂抹药物层，其与病变处接触面积不足，给药量和药物在血管壁表面的附着力不足，因而，相比在骨架41上涂抹药物层或直接注入血管治疗，采用上述膜扩张后接触病变的方式既提高了药物的利用率，又降低了毒性。
为便于操作，参照图1至图4和图13，本实施例的可选实施方式中，较为优选地但不限于，外层管组件200还包括滑动手柄5，该滑动手柄5连接于外管3的近端且套装于内管1外部，滑动手柄5配置成能够带动外管3相对内管1前后滑动。且较佳地但不限于，参考图20，滑动手柄5上还 设有滑动位置标记501，内管1的近端外壁设有沿内管1的轴向设置的刻度线102，该滑动位置标记501与刻度线102相互配合以显示外管3相对内管1前后滑动的距离，该滑动位置标记501可以但不限于为设于滑动手柄5外周壁上的标记环或标记凸起或标记线等；当滑动位置标记501与位于滑动手柄5的近端(后端)端面有一段距离时，滑动手柄5整体或至少与该滑动位置标记501近端(后端)侧对应的部位采用透明或半透明材料制成，以供术者观察，或者，也可以滑动手柄5的近端端面边缘作为上述滑动位置标记501。
为避免操作时发生漏血的问题，本实施例的一些优选实施方式中，该外层管组件200除外管3和扩缩部4之外，还包括密封装置52，该密封装置52配置成能够沿径向密封外管3的近端内壁和内管1外壁之间的管间隙；具体地，该密封装置52的具体设置方式包括但不限于：不管设不设置上述滑动手柄5，密封装置52的设置位置均位于外管3的近端内壁和内管1的外壁之间的管间隙中，进而直接沿径向密封外管3的近端内壁和内管1的外壁之间的间隙，或者，如图13所示，设有上述滑动手柄5，密封装置52的设置位置位于滑动手柄5的内壁和内管1的外壁之间，以密封滑动手柄5的内壁和内管1的外壁之间的间隙，进而间接沿径向密封外管3的近端内壁和内管1的外壁之间的间隙。此外，该密封装置52可以但不限于如图13所示，采用密封圈的结构，也可以是设于外管3近端(后端)或者滑动手柄5近端(后端)的环形后盖(未图示出)等结构。
另外，有研究表明，在超声能量的辅助下使如链激酶、尿激酶等溶栓剂进入到血栓的内部，可明显加快血栓溶解的速度，相对于此，在本实施例的一些优选实施方式中，如图13所示，在设置滑动手柄5的情况下，另在滑动手柄5上设手柄通液孔51，该手柄通液孔51与外管3和内管1之间的间隙连通；且使该手柄通液孔51位于密封装置52的远端侧；或者，在本实施例的另一些优选实施方式中，不管设置不设置上述滑动手柄5，均如图22所示，在外管3的近端壁上设贯通外管3的管壁的外管通液孔32，当既设外管通液孔32又设上述密封装置52的情况下，使上述外管通液孔32位于密封装置52的远端侧。在这些优选实施方式中，通过向该手柄通液孔51或外管通液孔32内推注溶栓药物，超声能量可以加速溶栓药物向血栓内部的渗透速度，极大提高血栓的溶解效率，进而做到有效的减容、扩张管腔，降低支架植入比例，提高短期和中长期的治疗效果，注入的溶栓药物可从外管3的远端管口流出，也可以如图14至图16所示，在外管3远端侧壁上设喷液孔31，以使溶栓药物能够从外管3的侧面喷出，更好地与血管壁接触，本实施例中，该手柄通液孔51或外管通液孔32也可以用来注射造影剂等其他诊疗液体。本实施例通过设上述手柄通液孔51或外管通液孔32，使该管腔开通器械兼具溶栓导管的功能，避免了单独通入溶栓导管注入溶栓液体的步骤，从而，进一步提高手术效率。
此外，在本实施例的一些可选实施方式中，可通过内管1近端向内管1内注入液体为内管1和外管3降温，保证手术内环境温度不过高，具体地，其结构可以是，如图22所示，在内管1的近端壁上设有贯通内管1的管壁的内管通液孔103，通过该内管通液孔103中注射液体，也可是，参照图1至图4以及图14、图15，超声接头组件2包括超声连接头21，该超声连接头21的近端设有配置成能与超声换能器7连接的连接部210；超声连接头21上设有内管连接孔211和连接头通液孔212， 内管1的近端连接于内管连接孔211的远端且内管1的管腔与内管连接孔211连通，连接头通液孔212与内管连接孔211连通，通过该连接头通液孔212注入液体为内管1和外管3降温，当然，也可以通过连接头通液孔212连接负压设备，以使内管1内部形成负压，从而对血栓部位开通时或溶栓过程中产生的碎屑进行抽吸。在通过连接头通液孔212注入液体为内管1和外管3降温的结构中，进一步优选地，该超声接头组件2还包括软管22和单向阀组件23；软管22的一端连接于连接头通液孔212，软管22远离连接头通液孔212的部位连接有仅允许液体自软管22经由连接头通液孔212流入内管连接孔211的单向阀组件23，超声工作时，通过软管22和单向阀组件23向连接头通液孔212注入液体。
需要特别说明的是，在本实施例的上述多个可选或优选的实施方式中，外管通液孔32、手柄通液孔51、内管通液孔103以及上述的连接头通液孔212均不局限于注射液体的种类，例如，外管通液孔32和手柄通液孔51还可以供注射超声降温液体，内管通液孔103和连接头通液孔212也可以供注射溶栓药物或造影剂等其他诊疗液体；此外，外管通液孔32、手柄通液孔51、内管通液孔103以及上述的连接头通液孔212可同时或择一或以任意组合方式进行选择性设置。
本实施例还提供一种管腔开通系统，如图15所示，该管腔开通系统包括超声发生器6、超声换能器7以及实施例一中任一可选实施方式提供的管腔开通器械，超声换能器7与超声发生器6连接，超声接头组件2与超声换能器7连接，超声发生器6可以但不限于通过图15所示脚驱动踏板8进行驱动。
另外，本公开实施例还提供一种管腔开通方法，该管腔开通方法使用前述第二方面所提供的管腔开通系统，将管腔开通器械的远端送入患者血管腔内闭塞处，启动超声发生器6，带动内管1振动，在内管1超声振动的同时，内管1的超声能量能够传递到连接于外管2远端的扩缩部4，以使处于扩张状态下的扩缩部4切割血栓。
由于本公开实施例提供的管腔开通方法应用前述管腔开通系统，管腔开通系统又包括前述管腔开通器械，因而，本公开实施例提供的管腔开通方法和管腔开通系统能够达到前述管腔开通器械能够达到的所有有益效果。
最后应说明的是：
1、本公开实施例提供的管腔开通器械、管腔开通系统及管腔开通方法不仅仅局限在应用在开通血管的手术场景时，该管腔开通器械和管腔开通系统可应用的管腔还包括输尿管、胆管等其他人体管腔。
2、本说明书中的各个实施例均采用递进的方式描述，每个实施例重点说明的都是与其它实施例的不同之处，各个实施例之间相同相似的部分相互参见即可；本说明书中的以上各实施例仅用以说明本公开的技术方案，而非对其限制；尽管参照前述各实施例对本公开进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本公开各实施例技术方案的范围。
工业实用性
综上，本公开实施例提供了一种管腔开通器械、管腔开通系统及管腔开通方法，至少缓解了现有闭塞性病变腔内介入治疗手术中，器械难以穿过病变闭塞段、器械操作繁琐、以及球囊扩张减容效果不佳需置入支架，支架内再狭窄导致远期通畅率低的问题，提高了手术即刻成功率和中远期效果，具有工业实用性。

Claims (25)

  1. 一种管腔开通器械，其特征在于：包括内层管组件(100)和外层管组件(200)；
    所述内层管组件(100)包括内管(1)和超声接头组件(2)，所述超声接头组件(2)连接于所述内管(1)的近端；
    所述外层管组件(200)包括外管(3)和连接于所述外管(3)的远端的至少一个扩缩部(4)；
    所述外管(3)和所述至少一个扩缩部(4)均套装于所述内管(1)的外部；
    所述扩缩部(4)配置成：具有整体贴合或贴近所述内管(1)外壁的收缩状态、以及沿所述内管(1)径向朝所述内管(1)的外部膨起的扩张状态，所述外层管组件(200)能够相对所述内管(1)运动，以使所述扩缩部(4)在所述扩张状态和所述收缩状态之间相互转变。
  2. 根据权利要求1所述的管腔开通器械，其特征在于：所述内管(1)的远端伸出于所述至少一个扩缩部(4)中最靠近所述内管(1)的远端的部位。
  3. 根据权利要求2所述的管腔开通器械，其特征在于：所述内管(1)的远端部位设有尖端(101)。
  4. 根据权利要求1至3中任一项所述的管腔开通器械，其特征在于：以最靠近所述内管(1)的远端的扩缩部(4)作为远端扩缩部，则：
    所述扩缩部(4)仅包括远端扩缩部；
    或者，
    所述扩缩部(4)具有至少两个，且以最远离所述内管(1)的远端的扩缩部(4)作为近端扩缩部，其中：所述至少两个扩缩部(4)首尾依次连接，所述外管(3)的远端连接于所述近端扩缩部的近端；或者，所述外管(3)包括近端管和多段远端管，所述至少两个扩缩部(4)两两间隔，且相邻两个所述扩缩部(4)之间通过至少一段所述远端管相连接，所述近端管的远端连接于所述近端扩缩部的近端。
  5. 根据权利要求1至4中任一项所述的管腔开通器械，其特征在于：所述至少一个扩缩部(4)中最靠近所述内管(1)的远端的部位，固定于所述内管(1)的远端外壁。
  6. 根据权利要求1至4中任一项所述的管腔开通器械，其特征在于：所述内管(1)的远端外壁设限位结构(11)，所述至少一个扩缩部(4)中最靠近所述内管(1)的远端的部位，被所述限位结构(11)限位于所述内管(1)的远端外壁。
  7. 根据权利要求6所述的管腔开通器械，其特征在于：以最靠近所述内管(1)的远端的扩缩部(4)作为远端扩缩部，则：所述远端扩缩部的远端还连接有约束固定部件(42)。
  8. 根据权利要求7所述的管腔开通器械，其特征在于：所述约束固定部件(42)包括固定环或固定管，所述固定环或固定管套装于所述内管(1)外部。
  9. 根据权利要求7或8所述的管腔开通器械，其特征在于：所述外管(3)能够相对所述内管(1)前后滑动，以使所述扩缩部(4)在所述扩张状态和所述收缩状态之间相互转变；所述限位结构(11)包括设于所述内管(1)远端外壁的远端阻挡凸起(111)，所述远端扩缩部的约束固定部件(42)被阻挡于所述远端阻挡凸起(111)的近端侧。
  10. 根据权利要求9所述的管腔开通器械，其特征在于：所述限位结构(11)还包括近端阻挡凸起(112)，所述近端阻挡凸起(112)位于所述远端扩缩部的约束固定部件(42)的近端侧。
  11. 根据权利要求1至10中任一项所述的管腔开通器械，其特征在于：所述外层管组件(200)还包括外鞘管(9)，所述外鞘管(9)套装于所述外管(3)的外部，所述外鞘管(9)能够相对所述外管(3)前后滑动，以将所述扩缩部(4)收拢或释放于所述外鞘管(9)的内壁与所述外管(3)的外壁之间的间隙。
  12. 根据权利要求1至11中任一项所述的管腔开通器械，其特征在于：
    所述扩缩部(4)包括骨架(41)，所述骨架(41)呈网格状或由多根沿所述内管(1)的轴向延伸的连接丝间隔排列而成。
  13. 根据权利要求12所述的管腔开通器械，其特征在于：所述扩缩部(4)还包括连接于所述骨架(41)的覆膜，所述覆膜由柔性材料制成。
  14. 根据权利要求1至13中任一项所述的管腔开通器械，其特征在于：所述外层管组件(200)还包括密封装置(52)，所述密封装置(52)配置成能够沿径向密封所述外管(3)的近端内壁和所述内管(1)的外壁之间的间隙。
  15. 根据权利要求14所述的管腔开通器械，其特征在于：所述外层管组件(200)还包括滑动手柄(5)，所述滑动手柄(5)连接于所述外管(3)的近端且套装于所述内管(1)外部，并且，所述滑动手柄(5)配置成能够带动所述外管(3)相对所述内管(1)前后滑动。
  16. 根据权利要求15所述的管腔开通器械，其特征在于：所述密封装置(52)的设置位置位于所述滑动手柄(5)的内壁和所述内管(1)的外壁之间，以沿径向密封所述滑动手柄(5)的内壁和所述内管(1)的外壁之间的间隙，进而间接沿径向密封所述外管(3)的近端内壁和所述内管(1)的外壁之间的间隙。
  17. 根据权利要求16所述的管腔开通器械，其特征在于：在所述滑动手柄(5)上设有手柄通液孔(51)，所述手柄通液孔(51)与所述外管(3)和所述内管(1)之间的间隙连通；且所述手柄通液孔(51)位于所述密封装置(52)的远端侧。
  18. 根据权利要求14或15所述的管腔开通器械，其特征在于：所述密封装置(52)的设置位置设于所述外管(3)的近端内壁和所述内管(1)的外壁之间的管间隙中，进而直接沿径向密封所述外管(3)的近端内壁和所述内管(1)的外壁之间的间隙。
  19. 根据权利要求15至17中任一项所述的管腔开通器械，其特征在于：所述滑动手柄(5)上设有滑动位置标记(501)，所述内管(1)的近端外壁设有沿所述内管(1)的轴向设置的刻度线(102)，所述滑动位置标记(501)与所述刻度线(102)相互配合以显示所述外管(3)相对所述内管(1)前后滑动的距离。
  20. 根据权利要求1至19中任一项所述的管腔开通器械，其特征在于：所述外管(3)的近端壁上设有贯通所述外管(3)的管壁的外管通液孔(32)。
  21. 根据权利要求1至20中任一项所述的管腔开通器械，其特征在于：所述内管(1)的近端壁上设有贯通所述内管(1)的管壁的内管通液孔(103)。
  22. 根据权利要求1至21中任一项所述的管腔开通器械，其特征在于：
    所述超声接头组件(2)包括超声连接头(21)；
    所述超声连接头(21)的近端设有配置成与超声换能器(7)连接的连接部(210)；所述超声连接头(21)上设有内管连接孔(211)和连接头通液孔(212)，所述内管(1)的近端连接于所述内管连接孔(211)的远端且所述内管(1)的管腔与所述内管连接孔(211)连通，所述连接头通液孔(212)与所述内管连接孔(211)连通。
  23. 根据权利要求22所述的管腔开通器械，其特征在于：所述超声接头组件(2)还包括软管(22)和单向阀组件(23)；所述软管(22)的一端连接于所述连接头通液孔(212)，所述软管(22)远离所述连接头通液孔(212)的部位连接有仅允许液体自所述软管(22)经由所述连接头通液孔(212)流入所述内管连接孔(211)的单向阀组件(23)。
  24. 一种管腔开通系统，其特征在于：包括超声发生器(6)、超声换能器(7)以及权利要求1至23中任一项所述的管腔开通器械，所述超声换能器(7)与所述超声发生器(6)连接，所述超声接头组件与所述超声换能器(7)连接。
  25. 一种管腔开通方法，其特征在于：使用权利要求24所述的管腔开通系统，将所述管腔开通器械的远端送入患者血管腔内闭塞处，启动所述超声发生器(6)，带动所述内管(1)振动，在所述内管(1)超声振动的同时，所述内管(1)的超声能量能够传递到连接于所述外管(3)远端的扩缩部(4)，以使处于扩张状态下的所述扩缩部(4)切割血栓。
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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115530923B (zh) * 2022-12-02 2023-03-31 北京华通集智医疗器械有限公司 管腔开通器械和管腔开通系统
CN116965884B (zh) * 2023-09-22 2024-02-27 北京华脉泰科医疗器械股份有限公司 血管闭塞开通器械

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5490859A (en) * 1992-11-13 1996-02-13 Scimed Life Systems, Inc. Expandable intravascular occlusion material removal devices and methods of use
US20130041391A1 (en) * 2011-08-11 2013-02-14 Boston Scientific Scimed, Inc. Expandable scaffold with cutting elements mounted thereto
CN107348990A (zh) * 2017-08-25 2017-11-17 江西理工大学 超声除栓系统
US20180280005A1 (en) * 2017-04-03 2018-10-04 C.R. Bard, Inc. Ultrasonic Endovascular Catheter with Expandable Portion
WO2022142964A1 (zh) * 2020-12-31 2022-07-07 杭州唯强医疗科技有限公司 取栓装置
CN114848092A (zh) * 2022-04-27 2022-08-05 晨兴(南通)医疗器械有限公司 用于配合取栓支架吸栓的双层导管系统
CN115177321A (zh) * 2022-06-14 2022-10-14 上海腾复医疗科技有限公司 多功能血栓清除装置
CN115530923A (zh) * 2022-12-02 2022-12-30 北京华通集智医疗器械有限公司 管腔开通器械和管腔开通系统

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6780183B2 (en) * 2002-09-16 2004-08-24 Biosense Webster, Inc. Ablation catheter having shape-changing balloon
CN202191333U (zh) * 2011-07-05 2012-04-18 科明技术（香港）有限公司 Pta球囊扩张导管
EP2938386B1 (en) * 2012-12-28 2019-01-30 Bard Peripheral Vascular, Inc. Drug delivery via mechanical vibration balloon
CN108283758B (zh) * 2018-01-24 2021-07-23 张海军 一种具有破、溶栓血栓抽吸功能的药物洗脱球囊导管
CN113796923A (zh) * 2020-06-12 2021-12-17 苏州天鸿盛捷医疗器械有限公司 一种血栓处理平台
CN112472968A (zh) * 2020-12-03 2021-03-12 广东博迈医疗器械有限公司 一种超声刻痕导管
CN114404034A (zh) * 2021-02-09 2022-04-29 杭州德诺电生理医疗科技有限公司 消融装置
CN113476136B (zh) * 2021-06-29 2022-09-20 苏州心岭迈德医疗科技有限公司 一种脉冲场消融控制方法及系统
CN113349922A (zh) * 2021-07-06 2021-09-07 上海安钛克医疗科技有限公司 电生理导管及电生理系统
CN115153749B (zh) * 2022-07-27 2024-04-19 上海百心安生物技术股份有限公司 一种超声碎石导管

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5490859A (en) * 1992-11-13 1996-02-13 Scimed Life Systems, Inc. Expandable intravascular occlusion material removal devices and methods of use
US20130041391A1 (en) * 2011-08-11 2013-02-14 Boston Scientific Scimed, Inc. Expandable scaffold with cutting elements mounted thereto
US20180280005A1 (en) * 2017-04-03 2018-10-04 C.R. Bard, Inc. Ultrasonic Endovascular Catheter with Expandable Portion
CN107348990A (zh) * 2017-08-25 2017-11-17 江西理工大学 超声除栓系统
WO2022142964A1 (zh) * 2020-12-31 2022-07-07 杭州唯强医疗科技有限公司 取栓装置
CN114848092A (zh) * 2022-04-27 2022-08-05 晨兴(南通)医疗器械有限公司 用于配合取栓支架吸栓的双层导管系统
CN115177321A (zh) * 2022-06-14 2022-10-14 上海腾复医疗科技有限公司 多功能血栓清除装置
CN115530923A (zh) * 2022-12-02 2022-12-30 北京华通集智医疗器械有限公司 管腔开通器械和管腔开通系统

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