WO2024108761A1 - 超声导引导管及超声导引的穿刺*** - Google Patents

超声导引导管及超声导引的穿刺*** Download PDF

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Publication number
WO2024108761A1
WO2024108761A1 PCT/CN2023/073314 CN2023073314W WO2024108761A1 WO 2024108761 A1 WO2024108761 A1 WO 2024108761A1 CN 2023073314 W CN2023073314 W CN 2023073314W WO 2024108761 A1 WO2024108761 A1 WO 2024108761A1
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WO
WIPO (PCT)
Prior art keywords
carrier
ultrasound
catheter body
puncture needle
assembly
Prior art date
Application number
PCT/CN2023/073314
Other languages
English (en)
French (fr)
Inventor
杨俊�
李雷
崔铁军
史胜凤
薛卫
Original Assignee
上海安钛克医疗科技有限公司
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Filing date
Publication date
Application filed by 上海安钛克医疗科技有限公司 filed Critical 上海安钛克医疗科技有限公司
Publication of WO2024108761A1 publication Critical patent/WO2024108761A1/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
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496—Protecting sleeves or inner probes; Retractable tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips

Definitions

  • the present invention relates to the technical field of medical devices, and in particular to an ultrasound-guided catheter and an ultrasound-guided puncture system.
  • the puncture needle is withdrawn, and the guide wire is passed through the puncture sheath again and sent into the left atrium, and then the puncture sheath is withdrawn from the body, and finally the atrial septum puncture system or other other instruments used for left atrial interventional surgery are sent into the left atrium along the guide wire.
  • various instruments need to be exchanged many times.
  • the doctor needs to judge the position of the instrument based on the feel feedback of the instrument in the patient and the X-ray plane image.
  • the physiological structure of different patients is different, and the direction of the puncture needle is not easy to judge under the X-ray plane image, which makes the puncture difficult and risky.
  • the operator needs to pay attention to the state of the puncture needle to avoid accidental extension of the puncture needle during the puncture process, causing mispuncture.
  • the length of the puncture needle extended under the X-ray image is difficult to judge, which makes it difficult to control the length, thereby increasing the risk of puncturing or damaging the myocardium or surrounding tissues and even causing pericardial tamponade.
  • existing intracardiac ultrasound catheters are all separate catheters that cannot share the same access route as surgical instruments and require a separate access route when used. There will be a space-occupying phenomenon during operation, resulting in interference between the imaging instrument and the treatment instrument when operating the instrument.
  • the imaging area of the ultrasound catheter has certain limitations and cannot provide an image of a large range or a specific area during surgery.
  • the object of the present invention is to provide an ultrasound-guided catheter and an ultrasound-guided puncture system to at least solve one of the technical problems existing in the prior art or related art.
  • the present invention provides an ultrasound-guided puncture system, comprising an adjustable curved sheath assembly, a dilator assembly, a puncture needle assembly, an ultrasound imaging assembly and a control assembly;
  • the adjustable bending sheath tube assembly comprises a sheath tube body, the sheath tube body comprises a first working channel, and the dilator body of the dilator assembly can pass through the first working channel;
  • the dilator body comprises a second working channel, and the puncture needle of the puncture needle assembly can pass through the second working channel to perform puncture;
  • the ultrasonic imaging assembly includes a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the distal end of the catheter body and have a retracted position and an open position, wherein the catheter body can safely pass through the tissue cavity in the retracted position; and wherein at least a portion of the carriers is opened away from the catheter body in the open position;
  • the catheter body is the sheath body or the dilator body
  • the control assembly is capable of switching the carrier from one of the retracted position and the open position to the other of the retracted position and the open position.
  • the present invention provides an ultrasound guided catheter comprising a catheter body, an ultrasound imaging component and a control component;
  • the catheter body comprises a working channel for passing an instrument;
  • the ultrasound imaging component comprises a plurality of carriers and a transducer unit arranged on the carriers, the carriers being arranged at the distal end of the catheter body and having a retracted position and an open position, in which the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier is opened away from the catheter body;
  • the control component can switch the carrier from one of the retracted position and the open position to the other of the retracted position and the open position.
  • the carrier includes at least a first end and a second end, the first end is connected to the catheter body, and the second end can be located at the open position away from the catheter body.
  • control component includes an expansion mechanism, which is connected to the second end, and the expansion mechanism can switch the carrier from the retracted position to the preset open position.
  • the first end of the carrier is hinged to the catheter body
  • the expansion mechanism includes a push wire
  • the carrier is attached to the outer wall of the catheter body
  • the second end of the carrier can be rotated relative to the catheter body to the preset open position by pushing the push wire.
  • the carrier includes at least a first end and a second end, a folding area is arranged between the first end and the second end, the first end is connected to the catheter body, and the control component is capable of moving the carrier in the folding area away from the catheter body to the preset open position or moving the carrier in the folding area from the open position away from the catheter body to the contracted position.
  • the carrier can be expanded to the open position to the maximum extent relative to the catheter body without being subjected to external force.
  • control component includes a retracting mechanism, which is capable of switching the carrier from the open position that is maximally opened to the retracted position.
  • the contraction mechanism includes a pull wire, the pull wire is connected to the second end, and Moving the pull wire can switch the second end from the open position to the retracted position; or
  • the retracting mechanism comprises a sleeve structure, which is movably disposed on the catheter body.
  • the second end can be switched from the open position to the retracted position by driving the sleeve structure to move relative to the catheter body.
  • a groove for accommodating the carrier is further provided on the outer wall of the catheter body.
  • a groove for accommodating the carrier is further provided on the outer wall of the catheter body, a recess is provided in the groove, the recess is used to accommodate the second end, and the push wire extends out of the groove from the surface of the recess and is connected to the second end.
  • a groove for accommodating the carrier is further provided on the outer wall of the catheter body, and a recess is provided in the groove, and the recess is used to accommodate the second end; the pull wire extends out of the groove through the surface of the recess and is connected to the second end.
  • the carrier includes a pivot portion, and the carrier can be rotated by the pivot portion to reach the preset open position, and the second end is formed integrally with the pivot portion.
  • the carrier is formed integrally with the catheter body, and a cable for connecting the transducer unit has no exposed portion between the carrier and the catheter body.
  • the carrier is S-shaped, and when the carrier is located at the open position, portions of the carrier located on both sides of the folding area are offset along the axial direction of the catheter body and the directions of the transducer units on the portions are consistent.
  • the carrier is a trumpet-shaped structure and can be folded and arranged in the catheter body.
  • the ultrasonic imaging component also includes a support member for supporting the carrier.
  • the support member is located in the catheter body and can be driven by the control component to move relative to the catheter body so that the second end is exposed from the catheter body and then expanded in a trumpet shape.
  • the carrier is a trumpet-shaped structure
  • the ultrasonic imaging assembly also includes a support member for supporting the carrier, and the support member can enable the carrier to be opened to the open position to the maximum extent relative to the catheter body without being subjected to external force; when the sleeve structure moves toward the distal end of the catheter body, the carrier can be retracted and arranged within the sleeve structure.
  • the carriers are symmetrically distributed around the center of the catheter body.
  • At least one transducer in the transducer unit is independently controllable.
  • the present invention also provides an ultrasound-guided puncture system, including the ultrasound-guided catheter as described above.
  • the puncture system also includes an adjustable bend sheath assembly, a dilator assembly and a puncture needle assembly;
  • the adjustable bend sheath assembly includes a sheath body, the sheath body includes a first working channel, and the dilator body of the dilator assembly can pass through the first working channel;
  • the dilator body includes a second working channel, and the puncture needle of the puncture needle assembly can pass through the second working channel for puncture;
  • the dilator body is connected to the second control mechanism of the dilator assembly;
  • the catheter body is the sheath body or the dilator body.
  • the puncture system further comprises a length adjuster
  • the puncture needle assembly comprises a third operating
  • the length adjuster is arranged between the third control mechanism and the second control mechanism of the expander assembly, and the distance between the second control mechanism and the third control mechanism is adjusted by adjusting the length adjuster, thereby adjusting the length of the puncture needle extending out of the expander body.
  • the length adjuster is threadably connected to one of the second control mechanism and the third control mechanism, and the length of the puncture needle extending out of the dilator body is adjusted by rotating the length adjuster.
  • a mark is provided on the thread of the length adjuster, and a scale is correspondingly provided on the shell of one of the second control mechanism and the third control mechanism, and the maximum length of the puncture needle extending out of the dilator body is obtained by observing the scale value aligned with the mark.
  • the third control mechanism further includes an operating member and a guide groove, wherein the operating member is located in the guide groove and can move in the guide groove to drive the puncture needle to retract or extend.
  • the puncture needle assembly includes a third control mechanism, and the third control mechanism also includes an energy storage assembly, and the energy storage assembly can act on the puncture needle to push the distal end of the puncture needle out of the dilator body.
  • the third control mechanism further includes an operating member and a guide groove, wherein the operating member is located in the guide groove and can move in the guide groove to lock or unlock the movement of the puncture needle.
  • the third operating mechanism further includes a limiting structure, which includes a limiting member arranged on the operating member and a stop member cooperating with the limiting member, and the limiting member cooperates with the stop member to lock the puncture needle in a locking position.
  • a limiting structure which includes a limiting member arranged on the operating member and a stop member cooperating with the limiting member, and the limiting member cooperates with the stop member to lock the puncture needle in a locking position.
  • the limiting structure further includes a first elastic member, which can apply force to the operating member to keep the limiting member and the stop member in abutment against each other in the locking position.
  • At least one of the limit member and the stop member includes a guiding bevel, and during the process of setting the puncture needle in the locking position, the limit member and the stop member can be set in the locking position through the guidance of the guiding bevel, thereby locking the puncture needle.
  • the operating member includes a channel for the stopper to pass through, and when tissue puncture is required, the stopper can pass through the channel to facilitate the distal end of the puncture needle to extend out of the dilator body.
  • the energy storage assembly of the third operating mechanism includes a second elastic member, the stop member is arranged on the puncture needle, one end of the second elastic member abuts against the stop member, and the other end abuts against the third operating mechanism; when the puncture needle is in the locked position, the limit member cooperates with the stop member to put the second elastic member in a compressed state, thereby limiting the movement of the puncture needle.
  • a liquid injection connector is provided at the proximal end of the puncture needle, and the stopper and the limiting member can be set in the locking position by pulling the liquid injection connector.
  • the present invention provides a puncture needle assembly, which includes a puncture needle and a control mechanism, wherein the puncture needle is arranged on the control mechanism, the puncture needle has a locked state and a released state, the control mechanism includes an energy storage component, an operating member and a limiting structure, and the energy storage component can act on
  • the puncture needle enables the distal end of the puncture needle to puncture tissue;
  • the limiting structure can keep the puncture needle in the locked state, in which the puncture movement of the puncture needle toward the tissue is restricted;
  • the operating member can switch the puncture needle from the locked state to the released state; in the released state, the puncture needle can puncture tissue under the action of the energy storage component.
  • the puncture needle assembly further includes a length adjuster, and the puncture depth of the puncture needle can be adjusted by adjusting the length adjuster.
  • the length adjuster is threadably connected to the control mechanism, and the puncture depth of the puncture needle is adjusted by rotating the length adjuster.
  • the present invention provides a puncture system, which includes the above-mentioned puncture needle assembly.
  • the puncture system also includes an adjustable bend sheath assembly, a dilator assembly and an ultrasonic imaging assembly;
  • the adjustable bend sheath assembly includes a sheath body, the sheath body includes a first working channel, and the dilator body of the dilator assembly can pass through the first working channel;
  • the dilator body includes a second working channel, and the puncture needle can pass through the second working channel for puncture;
  • the ultrasonic imaging assembly is arranged on the sheath body or the dilator body.
  • the present invention provides a puncture system, characterized in that it includes an adjustable bend sheath tube assembly, a dilator assembly and a puncture needle assembly;
  • the adjustable bend sheath tube assembly includes a sheath tube body, the sheath tube body includes a first working channel, and the dilator body of the dilator assembly can pass through the first working channel;
  • the dilator body includes a second working channel, and the puncture needle of the puncture needle assembly can pass through the second working channel for puncture;
  • the dilator body is connected to the second control mechanism of the dilator assembly;
  • the puncture needle assembly includes a puncture needle and a third control mechanism, and the puncture needle is arranged on the third control mechanism.
  • the puncture system also includes a length adjuster, and the length adjuster is arranged between the third control mechanism and the second control mechanism of the dilator assembly. The distance between the second control mechanism and the third control mechanism is adjusted by adjusting the length adjuster, thereby adjusting the length of the puncture needle extending out of the dilator body.
  • the present invention provides an ultrasound-guided catheter and an ultrasound-guided puncture system, which have at least one of the following beneficial effects:
  • the anatomical morphology of the atrial septum can be intuitively presented, providing a visual tissue structure within the instrument range, thereby better locating the appropriate puncture point on the atrial septum, guiding the operator's operation, reducing the risk of the operation, and facilitating the smooth progress of the operation;
  • FIG1 is a basic structural diagram of an ultrasound guidance catheter provided in Embodiment 1 of the present invention.
  • FIG2 is a schematic diagram of a closed carrier provided by Embodiment 1 of the present invention.
  • FIG3 is a schematic diagram of a carrier provided in Embodiment 1 of the present invention when it is unfolded;
  • FIG4 is a partial enlarged view of the carrier provided in Example 1 of the present invention when it is unfolded;
  • FIG5 is a schematic diagram of a hinge provided in Embodiment 1 of the present invention.
  • FIG6 is a schematic diagram of a push-type carrier with grooves provided in Embodiment 1 of the present invention.
  • FIG7 is a schematic diagram of a push-type carrier with a recess provided in Embodiment 2 of the present invention.
  • FIG8 is a schematic diagram of a foldable carrier with a push wire provided in Embodiment 2 of the present invention.
  • FIG9 is a schematic diagram of a foldable carrier with a sleeve provided in Embodiment 2 of the present invention.
  • FIG10 is a schematic diagram of a pop-up carrier with a pull line provided in Embodiment 3 of the present invention.
  • FIG11 is a schematic diagram of a front-pull type pop-up carrier with a recess provided in Embodiment 3 of the present invention.
  • FIG12 is a schematic diagram of a pop-up carrier with a recessed portion provided in a third embodiment of the present invention.
  • FIG13 is a schematic diagram of a pop-up carrier with an inclined groove provided in a third embodiment of the present invention.
  • FIG14 is a schematic diagram of a pop-up carrier with a sleeve provided in Embodiment 4 of the present invention.
  • FIG15 is a schematic diagram of a pop-up carrier closed and stored according to a fourth embodiment of the present invention.
  • FIG16 is a schematic diagram of an open-type storage of a pop-up carrier provided in a fourth embodiment of the present invention.
  • FIG17 is a schematic diagram of an S-shaped carrier with a sleeve provided in Embodiment 5 of the present invention.
  • FIG18 is a schematic diagram of an S-type carrier provided in Example 5 of the present invention.
  • FIG19 is a schematic diagram of a trumpet-shaped carrier provided in Example 6 of the present invention.
  • FIG20 is a schematic diagram of a trumpet-shaped carrier provided by Embodiment 6 of the present invention being received into a sleeve;
  • FIG21 is a top view of the trumpet-shaped sheet carrier provided in Example 6 of the present invention when it is unfolded;
  • FIG22 is a top view of a folded trumpet-shaped sheet carrier provided in Embodiment 6 of the present invention.
  • FIG23 is a schematic diagram of asymmetric distribution of linear carriers provided in Example 6 of the present invention.
  • FIG24 is a schematic diagram of the centrosymmetric distribution of linear carriers provided in Example 6 of the present invention.
  • FIG25 is a schematic diagram of the centrosymmetric distribution of S-shaped carriers provided in Example 6 of the present invention.
  • FIG26 is a schematic diagram of the arrangement of the transducer provided in Embodiment 6 of the present invention.
  • FIG27 is a schematic diagram of a puncture needle assembly provided in Embodiment 6 of the present invention.
  • FIG28 is a schematic diagram of the scale on the third control mechanism provided in Example 6 of the present invention.
  • FIG29 is a schematic diagram of a push-button puncture assembly in a locked position provided by Embodiment 1 of the present invention.
  • FIG30 is a schematic diagram of a push-button puncture assembly provided in Embodiment 1 of the present invention when unlocked;
  • FIG31 is a schematic diagram of another push-button puncture assembly provided in the first embodiment of the present invention in a locked position
  • FIG32 is a schematic diagram of another push-button puncture assembly provided in Embodiment 1 of the present invention when unlocked;
  • FIG. 33 is a schematic diagram of the pop-up puncture assembly provided in the second embodiment of the present invention when storing energy.
  • FIG. 34 is a schematic diagram of the pop-up puncture assembly provided in the second embodiment of the present invention after being popped out.
  • 1-1-working channel 2-1-first end of the carrier; 2-2-second end of the carrier;
  • 100-length adjuster 101-third control mechanism; 102-puncture needle; 103-marker; 104-operating member; 105-limiting member; 106-stop member; 107-first elastic member; 108-second elastic member; 109-liquid injection connector; 110-guide ramp.
  • the core idea of the present invention is to provide an ultrasound-guided catheter and an ultrasound-guided puncture system to solve the problems of difficult positioning of instruments and space occupation of ultrasound catheters during existing human interventional surgeries.
  • the ultrasound-guided puncture system includes an adjustable curved sheath assembly, a dilator assembly, a puncture needle assembly, an ultrasound imaging assembly and a control assembly;
  • the adjustable bending sheath tube assembly comprises a sheath tube body, the sheath tube body comprises a first working channel, and the dilator body of the dilator assembly can pass through the first working channel;
  • the dilator body comprises a second working channel, and the puncture needle of the puncture needle assembly can pass through the second working channel to perform puncture;
  • the ultrasonic imaging assembly includes a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the distal end of the catheter body and have a retracted position and an open position, wherein the catheter body can safely pass through the tissue cavity in the retracted position; and wherein at least a portion of the carriers is opened away from the catheter body in the open position;
  • the catheter body is the sheath body or the dilator body, etc.
  • the control assembly is capable of switching the carrier from one of the retracted position and the open position to the other of the retracted position and the open position.
  • the ultrasonic guide catheter comprises a catheter body, an ultrasonic imaging component and a control component;
  • the catheter body includes a working channel for the passage of instruments
  • the ultrasonic imaging assembly includes a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the distal end of the catheter body and have a retracted position and an open position, wherein the catheter body can safely pass through a tissue cavity in the retracted position; and wherein at least a portion of the carriers is opened away from the catheter body in the open position;
  • the control assembly is capable of switching the carrier from one of the retracted position and the open position to the other of the retracted position and the open position.
  • the ultrasonic imaging component by integrating the ultrasonic imaging component into the catheter body, it is possible to provide a visual tissue structure within the instrument range during human intervention surgery, thereby better locating the instrument's operating point, guiding the operator's operation, reducing the risk of the operation, and facilitating the smooth progress of the operation.
  • the ultrasonic imaging component is integrated into the catheter body, when a transatrial septal puncture operation is required, there is no need to exchange instruments such as the transatrial septal puncture system, puncture needle, guide wire, and sheath system multiple times, which greatly simplifies the surgical steps and reduces the risk of adverse events at unnecessary puncture sites.
  • the ultrasound guide catheter includes a catheter body 1, an ultrasound imaging component and a control component;
  • the catheter body 1 includes a working channel 1-1 for the passage of instruments
  • the ultrasonic imaging assembly includes a plurality of carriers 2 and a transducer unit 3 arranged on the carriers 2.
  • the carriers 2 are arranged at the distal end of the catheter body 1 and have a retracted position and an open position. In the retracted position, the catheter body 1 can safely pass through the tissue cavity, as shown in FIG2 ; in the open position, at least a portion of the carriers 2 is opened away from the catheter body 1, as shown in FIG3 ;
  • the control assembly is capable of switching the carrier 2 from one of the retracted position and the open position to the other of the retracted position and the open position.
  • proximal end generally refers to the end of the medical device that is close to the operator during normal operation
  • distal end generally refers to the end of the medical device that first enters the patient's body during normal operation.
  • working channel 1-1 is preferably not limited to the passage of a guide wire, but also allows other instruments other than a guide wire to pass through.
  • control component includes an expansion mechanism, which is connected to the second end, and the expansion mechanism can switch the carrier 2 from the retracted position to the preset open position.
  • the first end 2-1 of the carrier 2 is hinged to the catheter body 1, and the expansion mechanism includes a push wire 4.
  • the carrier 2 In the contracted position, the carrier 2 is attached to the outer wall of the catheter body 1, and the second end of the carrier 2 can be rotated relative to the catheter body 1 to the preset open position by pushing the push wire 4.
  • the open position can be opened to different angles relative to the axis of the catheter body 1 according to the needs of the imaging field of view.
  • the push wire 4 is arranged in the catheter body 1, and the position switching of the carrier 2 is achieved by pushing the push wire 4.
  • the push wire 4 can pull the second end of the carrier 2 so that the carrier 2 is attached to the catheter body 1.
  • the first end 2-1 of the carrier 2 is pivotally mounted on the catheter body 1 via a hinge 5, and the portion of the hinge 5 exposed from the catheter body 1 can be hinged to the first end 2-1 of the carrier 2, so that the carrier 2 can rotate around the hinge 5.
  • the carrier 2 includes a pivot portion, and the second end 2 - 2 of the carrier 2 can be rotated away from the catheter body 1 to reach the preset open position through the pivot portion, and the second end 2 - 2 of the carrier 2 is formed integrally with the pivot portion.
  • the distal and proximal end surfaces of the carrier 2 are both arc-shaped to reduce resistance and tissue damage when the ultrasound-guided catheter passes through the cavity.
  • the first end 2-1 of the carrier 2 is the distal end
  • the second end 2-2 of the carrier 2 is the proximal end.
  • the connector is located on the control assembly (such as a catheter control handle), and the connector can be connected to the ultrasound host module through the control assembly.
  • the cable 6 is a flexible cable, and in the retracted position, the portion of the cable 6 connecting the carrier 2 and the catheter body is located between the carrier 2 and the catheter body 1.
  • the portion of the flexible cable 6 can be flipped at a certain angle to ensure the connection between the transducer unit 3 and the host, as shown in FIGS. 3 and 4 .
  • the carrier 2 can be installed in different forms, which can be a single carrier 2 or a combination of multiple carriers 2.
  • the flipped carrier 2 can provide images at multiple different angles, and multiple different carriers 2 can be controlled by corresponding push wires 4 in the operating handle to produce detailed image effects at different orientations.
  • the outer wall of the catheter body 1 is further provided with a groove 7 for accommodating the carrier 2.
  • the ultrasonic imaging assembly can be stored in the groove 7, so that the carrier 2 and the hinge 5 of the ultrasonic imaging assembly do not protrude from the surface of the catheter body 1, thereby reducing the protrusion of the catheter body 1 and improving the passing performance of the ultrasonic guide catheter.
  • a groove 7 for accommodating the carrier is also provided on the outer wall of the catheter body, a recess 9 is provided in the recess 7, and the recess 9 is used to accommodate the second end.
  • the push wire 4 extends out of the groove 7 from the surface of the recess 9 and is connected to the second end to achieve a better storage effect.
  • the carrier 2 includes at least a first end 2-1 and a second end 2-2, a folding area is set between the first end 2-1 and the second end 2-2, the first end 2-1 is connected to the catheter body 1, and the control component can move the carrier 2 in the folding area away from the catheter body 1 to the preset open position or move the carrier 2 in the folding area from the open position away from the catheter body 1 to the contracted position.
  • the control component can be a push wire 4 or a sleeve structure 10.
  • the carrier 2 is a foldable carrier.
  • the second end 2-2 and the first end 2-1 of the carrier 2 are respectively connected to the sleeve structure 10 and the catheter body 1.
  • the sleeve structure 10 can be movably arranged on the catheter body 1. By driving the sleeve structure 10 to move relative to the catheter body 1, the carrier 2 can be moved away from the catheter body 1 in the folding area to the preset open position or the carrier 2 can be moved from the open position away from the catheter body 1 to the contracted position in the folding area.
  • the first end 2 - 1 of the carrier 2 is the distal end, and the second end 2 - 2 of the carrier 2 is the proximal end.
  • the carrier 2 can be opened to the open position to the maximum extent relative to the catheter body 1 without being subjected to external force.
  • control component includes a retracting mechanism, which can switch the carrier 2 from the open position that is maximally opened to the retracted position.
  • the retracting mechanism includes a pull wire 8, and the pull wire 8 is connected to the second end 2-2.
  • the pull wire 8 By pulling the pull wire 8, the second end 2-2 can be switched from the open position to the retracted position. Shrink position.
  • the outer wall of the catheter body 1 is also provided with a groove 7 for accommodating the carrier 2, and a recess 9 is provided in the groove 7, and the recess 9 is used to accommodate the second end 2-2, and the pull wire 8 extends out of the groove 7 from the surface of the recess 9 and is connected to the second end 2-2.
  • the pull wire 8 no longer extends from the side of the groove 7 on the catheter body 1, but extends from the bottom of the groove 7, there is a deeper area (i.e., the recess 9) in the entire groove 7, which is located at the extension of the pull wire 8, so that the carrier can be folded better, thereby deriving two ways of accommodating the carrier 2.
  • the pull wire 8 is connected to the proximal end of the carrier 2 (the second end 2-2 shown in Figure 11), and the proximal end of the carrier 2 is moved toward the surface of the catheter body 1 by pulling the pull wire 8; or, please refer to Figure 12, the pull wire 8 is connected to the distal end of the carrier 2 (the second end 2-2 shown in Figure 12), and the distal end of the carrier 2 is moved toward the surface of the catheter body 1 by pulling the pull wire 8.
  • the groove 7 is an inclined groove, and the depth of the groove 7 gradually increases toward the second end 2 - 2 to form a concave portion, which can also enable the carrier to obtain a better retracting effect.
  • the retraction mechanism includes a sleeve structure 10, and the sleeve structure 10 is movably arranged on the catheter body 1.
  • the second end 2-2 can be switched from the open position to the retracted position.
  • a plurality of receiving grooves for accommodating the carrier 2 are provided on the inner wall of the sleeve structure 10 or the outer wall of the catheter body 1 , and when the sleeve retracts the carrier 2 , the carrier 2 just fits into the receiving grooves of the sleeve structure 10 or the catheter body 1 .
  • the present application also derives two ways of accommodating the carrier 2 (the carrier can be selected to have an elastic material, such as a spring sheet, a nickel-titanium alloy, or a polymer).
  • the carrier 2 includes a pivot portion, and the pivot portion is arranged between the first end 2-1 and the second end 2-2. Please refer to FIG15. Through the pivot portion, the second end 2-2 of the carrier 2 rotates toward the first end 2-1 close to the carrier 2 and changes the opening angle of the carrier 2 relative to the catheter body 1. Alternatively, please refer to FIG16. Through the pivot portion, the second end 2-2 of the carrier 2 rotates toward the first end 2-1 away from the carrier 2 and changes the opening angle of the carrier 2 relative to the catheter body 1.
  • These two ways of accommodating the carrier 2 are applicable to both the pull wire 8 or the sleeve structure 10.
  • a groove for accommodating the carrier 2 may also be provided on the outer wall of the catheter body 1 .
  • the carrier 2 is S-shaped.
  • the portions of the carrier 2 located on both sides of the folding area are offset along the axial direction of the catheter body 1 and the transducer units 3 on the portions are oriented in the same direction.
  • the transducer units 3 are respectively installed on the inner and outer sides of the portions on both sides of the folding area of the S-shaped carrier.
  • the transducer unit 3 after the S-shaped carrier is pushed to be folded, the transducer units 3 on the inner and outer sides of the S-shaped carrier can have the same orientation after folding, and the transducer units 3 can be installed on both the inner and outer sides, and ultrasonic waves can be emitted in the same direction at the same time, thereby obtaining a higher ultrasonic emission density and imaging effect.
  • the carrier 2 is a trumpet-shaped structure that can be movably arranged on the distal end of the catheter and can be folded and arranged in the catheter body 1.
  • the ultrasonic imaging component also includes a support member 11 for supporting the carrier 2.
  • the support member 11 is located in the catheter body 1 and can be driven by the control component to move relative to the catheter body 1 so that the second end is exposed from the catheter body 1 and then expanded in a trumpet shape, or can be driven by the control component to move relative to the catheter body 1 so that the second end can be folded and arranged in the catheter body 1.
  • the carrier 2 is a trumpet-shaped structure disposed at the distal end of the catheter and can be folded and disposed in the sleeve structure 10. Please refer to Figures 19-21.
  • the carrier 2 is a trumpet-shaped structure.
  • the ultrasonic imaging assembly also includes a support member 11 for support.
  • the support members 11 are connected by flexible materials to form sectors. Folding folds are set on the flexible material according to the sectors, and circuits are arranged and transducers are placed.
  • the support member 11 can enable the carrier 2 to open to the open position to the maximum extent relative to the catheter body 1 without being subjected to external forces; when the sleeve structure 10 moves toward the distal end of the catheter body 1, the flexible material is folded and folded according to the set folds, so that the carrier 2 can be folded and disposed in the sleeve structure 10.
  • the transducers arranged on the flexible material can form a single transducer array, and the ultrasonic transducers in all the fan-shaped areas can form a larger transducer array.
  • the imaging area is related to the unfolded geometry of the veneer, and the tissue structure in front of the distal end of the catheter body 1 can be seen.
  • the support member 11 is a highly elastic wire material, such as spring steel, nickel-titanium metal, titanium alloy, etc.
  • the support member 11 includes multiple ones and is fixed by an annular fixing member to enhance the connection strength between the support members 11.
  • a preferred optimized embodiment can replace the wire in the trumpet-shaped structure carrier 2 with a predetermined high-elastic sheet (such as spring steel, nickel-titanium metal, titanium alloy, etc.), place a fixing ring to enhance the connection strength between the sheets and the connection strength between the sheets and the catheter body 1, cancel the flexible material originally folded by sectors on the wire, and directly arrange the flexible circuit and transducer on the high-elastic sheet.
  • a predetermined high-elastic sheet such as spring steel, nickel-titanium metal, titanium alloy, etc.
  • the carrier 2 may be single or multiple.
  • the carrier 2 may be distributed on one side of the catheter body 1, as shown in FIG23, or around the catheter body 1.
  • the catheter body 1 is centrally symmetrically distributed, as shown in Figures 24 and 25.
  • the present application does not impose any limitation on this. Considering the actual accommodating capacity and the overlap of ultrasonic coverage, the number of the carriers 2 is not more than 8.
  • a transducer unit 3 may include a single transducer or a plurality of transducer arrays, as shown in FIG26.
  • the transducer may be mounted on the outside or inside of the carrier 2, and the spacing d between the plurality of transducers on a single carrier 2 is between 0.2 ⁇ and 1.2 ⁇ ( ⁇ is the wavelength of the ultrasonic wave emitted by the transducer).
  • the array may be composed of a plurality of transducers on a single carrier 2, or may be composed of different transducers on a plurality of carriers 2.
  • the plurality of transducers may be grouped, and the plurality of transducers in a single group may transmit and receive at the same time, and the transducers in the group form the effect of a single transducer. In special cases, when all transducers transmit and receive at the same time, the entire transducer array forms the effect of a single transducer.
  • the host of the ultrasonic system controls the transducer through the cable 6, so that the transducer array transmits ultrasonic waves in a specific sequence, reaches the effect of the phased array, and enhances the ultrasonic imaging effect of a specific area.
  • the present invention provides an ultrasound-guided puncture system, comprising the ultrasound-guided catheter as described above.
  • the puncture system also includes an adjustable bending sheath assembly, a dilator assembly and a puncture needle assembly;
  • the adjustable bending sheath tube assembly comprises a sheath tube body, the sheath tube body comprises a first working channel, and the dilator body of the dilator assembly can pass through the first working channel;
  • the expander body comprises a second working channel, and the puncture needle of the puncture needle assembly can pass through the second working channel to perform puncture; the expander body is connected to a second control mechanism of the expander assembly;
  • the catheter body is the sheath body or the dilator body.
  • the dilator body is a hollow tubular structure, and has a second working channel inside for the puncture needle to enter and exit.
  • the distal end of the dilator body has a certain taper to facilitate passing through the atrial septum.
  • the puncture system further includes a length adjuster 100
  • the puncture needle assembly includes a third control mechanism 101
  • the length adjuster 100 is arranged between the third control mechanism 101 and the second control mechanism of the dilator assembly (not shown in the figure), and the distance between the second control mechanism and the third control mechanism 101 is adjusted by adjusting the length adjuster 100, thereby adjusting the length of the puncture needle 102 extending out of the dilator body.
  • the distance between the third control mechanism 101 and the second control mechanism can be adjusted, thereby adjusting the length of the puncture needle 102 extending out of the dilator body; or, by adjusting the relative position between the length adjuster 100 and the second control mechanism, the distance between the third control mechanism 101 and the second control mechanism can be adjusted, thereby adjusting the length of the puncture needle 102 extending out of the dilator body.
  • the length adjuster 100 is provided to solve the problem that the length of the conventional puncture needle 102 is difficult to judge under X-ray images, which makes the length control difficult and increases the risk of puncturing or damaging the heart. Problems with the muscles or surrounding tissue may even create a risk of pericardial tamponade.
  • the relative movement between the length adjuster 100 and the second operating mechanism or the third operating mechanism 101 includes but is not limited to tight fit movement, bayonet insertion and extraction, threaded rotation, etc.
  • the length adjuster 100 is threadedly connected to one of the second control mechanism and the third control mechanism 101, and the length of the puncture needle 102 extending from the dilator body is adjusted by rotating the length adjuster 100.
  • the length adjuster 100 is threadedly connected to the third control mechanism 101.
  • a mark 103 is provided on the thread of the length adjuster 100, and a scale is correspondingly provided on the housing of one of the second control mechanism and the third control mechanism 101, and the maximum length of the puncture needle 102 extending out of the dilator body is obtained by observing the scale value aligned with the mark 103.
  • the specific length of the puncture needle 102 extending out can be determined without checking the extension of the puncture needle 102 by observing the scale value aligned with the mark 103 on the length adjuster 100.
  • the mark when the mark is aligned with the scale zero point, it means that when the puncture needle 102 extends to the maximum stroke, the distal end of the puncture needle 102 is aligned with the distal end of the dilator body.
  • the mark when the mark is aligned with the scale "3", it means that when the puncture needle 102 extends to the maximum stroke, the puncture needle 102 exceeds the distal end of the dilator body by 3 units.
  • the length adjuster 100 may also be a retractable mechanism connected between the second control mechanism and the third control mechanism 101.
  • the “retractable mechanism” is common knowledge and will not be described in detail herein.
  • the third control mechanism 101 further includes an operating member 104 and a guide groove, wherein the operating member 104 is located in the guide groove and can move in the guide groove to drive the puncture needle 102 to extend and retract.
  • the third control mechanism 101 further includes an operating member and a guide groove, wherein the operating member is located in the guide groove and can move in the guide groove to lock or unlock the movement of the puncture needle.
  • the operating member 104 is a push button movably arranged on the third operating mechanism 101, and the push button is movably connected to the puncture needle 102.
  • the third operating mechanism 101 also includes a limiting structure, which includes a limiting member 105 arranged on the operating member 104 and a stopper 106 cooperating with the limiting member 105.
  • the limiting member 105 cooperates with the stopper 106 to lock the puncture needle 102 in a locked position.
  • the limiting member 105 can be disengaged from the stop member 106 to unlock the puncture needle 102 , and then continuing to push the push button can drive the puncture needle 102 to move along its pushing direction, that is, control the extension or retraction of the puncture needle 102 .
  • the length of the guide groove can be adjusted to adjust the length of the operating member 104 along the threading
  • the amount of movement of the puncture needle 102 in the pushing direction is adjusted, thereby adjusting the pushing amount of the puncture needle 102.
  • the push button and the third operating mechanism are correspondingly provided with the limiter 105 and the stopper 106.
  • the stopper 106 In the locked position, the stopper 106 is close to the distal end of the puncture needle 102 relative to the limiter 105, and the limiter 105 and the stopper 106 abut against each other and limit the movement of the puncture needle 102; when the push button is pressed down, the limiter 105 is vertically staggered from the stopper 106, that is, the stopper 106 is no longer located on the stroke of the limiter 105, which is equivalent to unlocking the puncture needle 102.
  • the downward pressure on the push button can be released, and the puncture needle 102 can be driven to move along its pushing direction by driving the push button to move along the pushing direction of the puncture needle 102.
  • the push button and the third operating mechanism are correspondingly provided with the limiter 105 and the stopper 106.
  • the stopper 106 In the locked position, the stopper 106 is close to the distal end of the puncture needle 102 relative to the limiter 105, and the distal end of the limiter 105 and the stopper 106 are mutually engaged, and the movement of the puncture needle 102 is limited; when the push button is pressed down, the limiter 105 and the stopper 106 are separated from each other, that is, the stopper 106 is no longer located on the stroke of the limiter 105, which is equivalent to unlocking the puncture needle 102.
  • the downward pressure on the push button can be released, and the puncture needle 102 can be driven to move along its pushing direction by driving the push button to move along the pushing direction of the puncture needle 102.
  • the limiting structure further includes a first elastic member 107, which can apply force to the operating member 104 to keep the limiting member 105 and the stopper 106 in contact with each other in the locking position.
  • the first elastic member 107 is located at the bottom of the push button and applies a vertical upward force to the push button to ensure that the limiting member 105 can be blocked by the stopper 106 when the push button is accidentally stressed, so as to prevent the puncture needle 102 from accidentally extending.
  • the first elastic member 107 is, for example, a spring, a shrapnel, etc., which is not limited in this application.
  • At least one of the limit member 105 and the stop member 106 includes a guiding bevel 110.
  • the limit member 105 and the stop member 106 can be set in the locking position through the guidance of the guiding bevel 110, thereby locking the puncture needle 102.
  • a liquid injection connector 109 is provided at the proximal end of the puncture needle 102, and the stopper 106 and the limiting member 105 can be set in the locking position by pulling the liquid injection connector 109.
  • the stopper 106 is arranged on the puncture needle 102, the operating member 104 can be moved vertically in the guide groove, such as by pressing, and the operating member 104 includes a channel for the stopper 106 to pass through, and the limiter 105 can be understood as the lower area of the channel.
  • the stopper 106 In the locked position, the stopper 106 is close to the proximal end of the puncture needle 102 relative to the operating member 104, and the stopper 106 and the limiter 105 abut against each other, and limit the movement of the puncture needle 102;
  • the limiting member 105 When the operating member 104 is pressed down, the limiting member 105 is vertically offset from the stop member 106, that is, the limiting member 105 is no longer located on the stroke of the stop member 106, so that the stop member 106 can pass through the channel, thereby facilitating the distal end of the puncture needle 102 to extend out of the dilator body.
  • the puncture needle 102 assembly includes a third control mechanism 101, and the third control mechanism 101 also includes an energy storage assembly, which can act on the puncture needle 102 to push the distal end of the puncture needle 102 out of the dilator body.
  • the energy storage device By setting the energy storage device, the stored energy can be converted into the puncture speed of the puncture needle 102, and the puncture speed of the puncture needle 102 is increased during puncture, so that there is no need to artificially push the atrial septum out of the tenting syndrome, reducing the risk of puncture.
  • the energy storage component of the third operating mechanism 101 includes a second elastic member 108, as shown in Figures 33-34, the stopper 106 is arranged on the puncture needle 102, one end of the second elastic member 108 abuts against the stopper 106, and the other end abuts against the third operating mechanism 101; when the puncture needle 102 is in the locked position, the limiter 105 cooperates with the stopper 106 to make the second elastic member 108 in a compressed state, thereby limiting the movement of the puncture needle 102.
  • the second elastic member 108 plays an energy storage role, and is used to push the puncture needle 102 out, and its structure includes but is not limited to a spring, a cylinder, an air bag, etc.
  • the puncture needle 102 is pulled back before use, the spring is compressed, and at the same time, the limiter 105 on the operating member 104 blocks the stopper 106, and the puncture needle 102 is in a locked state, and the energy storage is completed.
  • the operating member 104 is pressed downward, the limiting member 105 vertically offsets the stop member 106, the puncture needle 102 is released, and under the action of the spring, the expander against the atrial septum is extended at a relatively high speed to puncture the atrial septum, and the puncture is completed.
  • the limiting structure further includes a first elastic member 107, which can apply force to the operating member 104 to keep the limiting member 105 and the stopper 106 in contact with each other in the locking position.
  • the first elastic member 107 is located at the bottom of the push button and applies a vertical upward force to the push button to ensure that the stopper 106 can be blocked by the limiting member 105 under the action of the first elastic member 107 to prevent the puncture needle 102 from accidentally extending.
  • the first elastic member 107 is, for example, a spring, a shrapnel, etc., which is not limited in this application.
  • At least one of the limit member 105 and the stop member 106 includes a guiding bevel 110.
  • the limit member 105 and the stop member 106 can be set in the locking position through the guidance of the guiding bevel 110, thereby locking the puncture needle 102.
  • a liquid injection connector 109 is provided at the proximal end of the puncture needle 102, and the stopper 106 and the limiting member 105 can be set in the locking position by pulling the liquid injection connector 109.
  • the present invention provides an ultrasound-guided catheter, which can provide a visual tissue structure within the instrument range by integrating an ultrasound imaging component into the catheter body, thereby better locating the puncture point, guiding the operator's operation, reducing the risk of the operation, and facilitating the smooth progress of the operation.
  • the present invention also provides an ultrasound-guided puncture system, which solves the problem that the extended length of a traditional puncture needle is difficult to judge under X-ray images, resulting in greater difficulty in length control, thereby increasing the risk of puncturing or damaging the myocardium or surrounding tissues and even causing pericardial tamponade, by adding a length adjuster between the second control mechanism of the expander assembly and the third control mechanism of the puncture needle assembly.

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Abstract

一种超声导引导管及超声导引的穿刺***，穿刺***包括可调弯鞘管组件、扩张器组件、穿刺针组件、超声成像组件和控制组件；可调弯鞘管组件包括鞘管本体，鞘管本体包括供扩张器组件的扩张器本体通过的第一工作通道；扩张器本体包括供穿刺针组件的穿刺针（102）通过的第二工作通道；超声成像组件包括若干载体（2）及设置在载体（2）上的换能器单元（3），载体（2）设置在导管本体（1）的远端，并具有收缩位置和打开位置，在收缩位置，导管本体（1）能够安全通过组织腔道；在打开位置，载体（2）的至少一部分远离导管本体（1）张开；控制组件能够使载体（2）在收缩位置和打开位置之间。超声导引导管及超声导引的穿刺***解决了现有的进行人体介入手术时器械难以定位以及超声导管占位的问题。

Description

超声导引导管及超声导引的穿刺*** 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种超声导引导管及超声导引的穿刺***。
背景技术
正常情况下经皮途径导管不能顺行直接到达左心房。虽然可以逆行通过主动脉瓣和二尖瓣的两个转弯进入左心房，但导管操作上很麻烦。因此，临床上对于左心房介入治疗的手术通常由股静脉进入心脏右房，然后通过右房与左房的房间隔穿刺，放入鞘管作为通道，器械经鞘管送入左房。
目前常用的左房通路建立方法是完成股静脉穿刺后，经由导丝将头端形状固定的房间隔穿刺***管送入右心房，撤出导丝后送入房间隔穿刺针，通常在X射线下寻找到卵圆窝位置后用穿刺针进行穿刺，然后将穿刺鞘穿过穿刺点进入左心房，穿刺完成后撤回穿刺针，重新将导丝穿过穿刺鞘送入左心房，然后再将穿刺鞘撤回体外，最后沿导丝将房间隔穿刺***或其他用于左心房介入手术的其他器械送入左心房。在整个左心房通路建立过程中需要多次交换各种器械，先由导丝导引使房间隔穿刺***就位，然后撤出导丝，使用房间隔穿刺针穿刺房间隔，再然后将穿刺针撤出，送导丝过房间隔后撤出房间隔穿刺***，最后由导丝导引使鞘管通路就位。整个通路建立过程涉及了房间隔穿刺***、房间隔穿刺针、导引导丝及鞘管***等器械，步骤繁琐且需要多次造影，同时增加了不必要的穿刺部位的不良事件风险。
此外，在实际操作中，医生需凭器械在病患内的手感反馈及X射线的平面影像来判断器械所处位置。不同病患间的生理结构不同，X射线平面影像下穿刺针的方向不易判断，在穿刺时难度大，风险较高。同时在穿刺前后，施术者需要注意穿刺针的状态，避免在穿刺过程中，穿刺针意外伸出造成误穿刺。另外，穿刺时，穿刺针在X射线影像下伸出的长度较难判断，导致长度控制难度较大，从而增加了刺破或损伤心肌或周围组织甚至造成心包填塞的风险。
此外，现有的心腔内超声导管均为单独导管，无法与手术器械通用入路，使用时需要单独入路。在操作时会有占位现象，导致操作器械时，提供影像的器械与治疗器械会有干涉。超声导管的成像区域有一定的局限性，在施术时无法提供一个大范围或者是特定区域的影像。
发明内容
本发明的目的在于提供一种超声导引导管及超声导引的穿刺***，以至少解决现有技术或相关技术中存在的技术问题之一。
为了达到上述目的，第一方面，本发明提供了一种超声导引的穿刺***，包括可调弯鞘管组件、扩张器组件、穿刺针组件、超声成像组件和控制组件；
所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；
所述扩张器本体包括第二工作通道，所述穿刺针组件的穿刺针能够通过所述第二工作通道以进行穿刺；
所述超声成像组件包括若干载体及设置在所述载体上的换能器单元，所述载体设置在导管本体的远端，并具有收缩位置和打开位置，在所述收缩位置，所述导管本体能够安全通过组织腔道；在所述打开位置，所述载体的至少一部分远离所述导管本体张开；
所述导管本体为所述鞘管本体或所述扩张器本体；
所述控制组件能够使所述载体从所述收缩位置和所述打开位置中的一者切换到所述收缩位置和所述打开位置中的另一者。
第二方面，本发明提供了一种超声导引导管，包括导管本体、超声成像组件和控制组件；所述导管本体包括供器械通过的工作通道；所述超声成像组件包括若干载体及设置在所述载体上的换能器单元，所述载体设置在所述导管本体的远端，并具有收缩位置和打开位置，在所述收缩位置，所述导管本体能够安全通过组织腔道；在所述打开位置，所述载体的至少一部分远离所述导管本体张开；所述控制组件能够使所述载体从所述收缩位置和所述打开位置中的一者切换到所述收缩位置和所述打开位置中的另一者。
可选的，所述载体至少包括第一端和第二端，所述第一端与所述导管本体连接，所述第二端能够位于远离所述导管本体的所述打开位置。
可选的，所述控制组件包括扩张机构，所述扩张机构与所述第二端连接，所述扩张机构能够使所述载体从所述收缩位置向预设的所述打开位置切换。
可选的，所述载体的所述第一端与所述导管本体铰接，所述扩张机构包括推线，所述载体贴合于所述导管本体的外壁上，通过推动所述推线能够使所述载体的所述第二端相对所述导管本体向预设的所述打开位置转动。
可选的，所述载体至少包括第一端和第二端，在所述第一端和所述第二端之间设置折叠区，所述第一端与所述导管本体连接，所述控制组件能够使所述载体在所述折叠区远离所述导管本体向预设的所述打开位置移动或使所述载体在所述折叠区从远离所述导管本体的所述打开位置向所述收缩位置移动。
可选的，所述载体相对所述导管本体在不受外力的情况下能够以最大程度张开到所述打开位置。
可选的，所述控制组件包括收缩机构，所述收缩机构能够使所述载体从最大程度张开的所述打开位置切换到所述收缩位置。
可选的，所述收缩机构包括拉线，所述拉线与所述第二端连接，通过拉 动所述拉线能够使所述第二端从所述打开位置切换到所述收缩位置；或
所述收缩机构包括套筒结构，所述套筒结构能够移动地设置在所述导管本体上，通过驱使所述套筒结构相对所述导管本体移动能够使所述第二端从所述打开位置切换到所述收缩位置。
可选的，所述导管本体的外壁上还设置有用于容纳所述载体的凹槽。
可选的，所述导管本体的外壁上还设置有用于容纳所述载体的凹槽，所述凹槽中设置有凹部，所述凹部用于容纳所述第二端，所述推线由所述凹部的表面伸出所述凹槽并与所述第二端连接。
可选的，所述导管本体的外壁上还设置有用于容纳所述载体的凹槽，所述凹槽中设置有凹部，所述凹部用于容纳所述第二端；所述拉线通过所述凹部的表面伸出所述凹槽与所述第二端连接。
可选的，所述载体包括枢转部，所述载体能够通过所述枢转部旋转到达预设的所述打开位置，所述第二端与所述枢转部一体形成。
可选的，所述载体与所述导管本体一体形成，用于连接所述换能器单元的电缆在所述载体和所述导管本体之间无外露部分。
可选的，所述载体呈S形，当所述载***于所述打开位置时，所述载体的位于所述折叠区两侧的部分沿所述导管本体的轴向错位且该部分上的换能器单元的朝向一致。
可选的，所述载体为喇叭状结构且能够收拢地设置在所述导管本体内，所述超声成像组件还包括用于支撑所述载体的支撑件，所述支撑件位于所述导管本体内且能够通过所述控制组件的驱使相对所述导管本体移动以使所述第二端露出所述导管本体后呈喇叭状展开。
可选的，所述载体为喇叭状结构，所述超声成像组件还包括用于支撑所述载体的支撑件，所述支撑件能够使所述载体相对所述导管本体在不受外力的情况下以最大程度张开到所述打开位置；当所述套筒结构向所述导管本体的远端移动时，所述载体能够收拢地设置在所述套筒结构内。
可选的，所述载体绕所述导管本体的中心对称分布。
可选的，所述换能器单元中的至少一个换能器能够独立控制。
基于此，本发明还提供了一种超声导引的穿刺***，包括如上所述的超声导引导管。
可选的，所述穿刺***还包括可调弯鞘管组件、扩张器组件和穿刺针组件；所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；所述扩张器本体包括第二工作通道，所述穿刺针组件的穿刺针能够通过所述第二工作通道以进行穿刺；所述扩张器本体与所述扩张器组件的第二操控机构连接；所述导管本体为所述鞘管本体或所述扩张器本体。
可选的，所述穿刺***还包括长度调节器，所述穿刺针组件包括第三操 控机构，所述长度调节器设置于所述第三操控机构与所述扩张器组件的第二操控机构之间，通过调节所述长度调节器调节所述第二操控机构与所述第三操控机构之间的间距，进而调节所述穿刺针伸出所述扩张器本体的长度。
可选的，所述长度调节器与所述第二操控机构及所述第三操控机构中的一者螺纹连接，通过旋转所述长度调节器以调节所述穿刺针伸出所述扩张器本体的长度。
可选的，所述长度调节器的螺纹处设置有一标记，所述第二操控机构与所述第三操控机构中的所述一者的壳体上对应设置一刻度，通过观察所述标记对准的刻度值以获取所述穿刺针伸出所述扩张器本体的最大长度。
可选的，所述第三操控机构还包括操作件和导向槽，所述操作件位于所述导向槽内且能够在所述导向槽内移动以驱使所述穿刺针伸缩。
可选的，所述穿刺针组件包括第三操控机构，所述第三操控机构还包括蓄能组件，所述蓄能组件能够作用于所述穿刺针，以将所述穿刺针的远端推出所述扩张器本体。
可选的，所述第三操控机构还包括操作件和导向槽，所述操作件位于所述导向槽内且能够在所述导向槽内移动以锁定或解锁所述穿刺针的运动。
可选的，所述第三操控机构还包括限位结构，所述限位结构包括设置于所述操作件上的限位件及与所述限位件配合的止挡件，所述限位件与所述止挡件配合以在锁定位置锁定所述穿刺针。
可选的，所述限位结构还包括第一弹性件，所述第一弹性件能够向所述操作件施加力，以在所述锁定位置，使所述限位件与所述止挡件保持相互抵接。
可选的，所述限位件与所述止挡件中的至少一者包括引导斜面，在将所述穿刺针设置在所述锁定位置的过程中，通过所述引导斜面的引导，所述限位件与所述止挡件能够设置在所述锁定位置，进而锁定所述穿刺针。
可选的，所述操作件包括供所述止挡件通过的通道，在需要组织穿刺时，所述止挡件能够通过所述通道，以便于所述穿刺针的远端伸出所述扩张器本体。
可选的，所述第三操控机构的蓄能组件包括第二弹性件，所述止挡件设置在所述穿刺针上，所述第二弹性件的一端与所述止挡件相抵接，另一端与所述第三操控机构抵接；所述穿刺针处于锁定位置时，所述限位件与所述止挡件相配合，使所述第二弹性件处于压缩状态，限制所述穿刺针的运动。
可选的，所述穿刺针的近端设置注液接头，通过拉动所述注液接头能够将所述止挡件与所述限位件设置在所述锁定位置。
第三方面，本发明提供了一种穿刺针组件，其包括穿刺针和操控机构，所述穿刺针设置在所述操控机构上，所述穿刺针具有锁定状态和释放状态，所述操控机构包括蓄能组件、操作件和限位结构，所述蓄能组件能够作用于 所述穿刺针，使所述穿刺针的远端穿刺组织；所述限位结构能够将所述穿刺针保持在所述锁定状态，在所述锁定状态，所述穿刺针向所述组织的穿刺运动被限制；所述操作件能够使所述穿刺针由所述锁定状态切换到所述释放状态；在所述释放状态，所述穿刺针在所述蓄能组件的作用下，能够穿刺组织。
可选的，所述穿刺针组件还包括长度调节器，通过调节所述长度调节器能够调节所述穿刺针的穿刺深度。
可选的，所述长度调节器与所述操控机构螺纹连接，通过旋转所述长度调节器以调节所述穿刺针的穿刺深度。
第四方面，本发明提供了一种穿刺***，其包括上述穿刺针组件。
可选的，所述穿刺***还包括可调弯鞘管组件、扩张器组件和超声成像组件；所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；所述扩张器本体包括第二工作通道，所述穿刺针能够通过所述第二工作通道以进行穿刺；所述超声成像组件设置在所述鞘管本体或所述扩张器本体上。
第五方面，本发明提供了一种穿刺***，其特征在于，包括可调弯鞘管组件、扩张器组件和穿刺针组件；所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；所述扩张器本体包括第二工作通道，所述穿刺针组件的穿刺针能够通过所述第二工作通道以进行穿刺；所述扩张器本体与所述扩张器组件的第二操控机构连接；穿刺针组件包括穿刺针和第三操控机构，所述穿刺针设置在所述第三操控机构上，所述穿刺***还包括长度调节器，所述长度调节器设置于所述第三操控机构与所述扩张器组件的第二操控机构之间，通过调节所述长度调节器调节所述第二操控机构与所述第三操控机构之间的间距，进而调节所述穿刺针伸出所述扩张器本体的长度。
本发明提供了一种超声导引导管及超声导引的穿刺***，至少具有以下有益效果之一：
1)通过将超声成像组件集成至导管本体上，能够对房间隔的解剖形态有直观的图像呈现，提供器械范围内的可视化组织结构，从而更好地定位房间隔上适宜的穿刺点，指导手术者操作，减小施术的风险，便于手术顺利进行；
2)通过将超声成像组件集成至导管本体上，解决了现有的进行人体介入手术时器械难以定位以及超声导管占位的问题；
3)通过在扩张器组件的第二操控机构与穿刺针组件的第三操控机构之间增设通过设置长度调节器，解决了传统的穿刺针在X射线影像下伸出的长度较难判断，导致长度控制难度较大，从而增加了刺破或损伤心肌或周围组织甚至造成心包填塞风险的问题。
附图说明
本领域的普通技术人员将会理解，提供的附图用于更好地理解本发明，而不对本发明的范围构成任何限制。其中：
图1为本发明实施例一提供的超声导引导管的基本结构图；
图2为本发明实施例一提供的载体闭合时的示意图；
图3为本发明实施例一提供的载体展开时的示意图；
图4为本发明实施例一提供的载体展开时的局部放大图；
图5为本发明实施例一提供的铰接件的示意图；
图6为本发明实施例一提供的带凹槽的推送式载体的示意图；
图7为本发明实施例二提供的带凹部的推送式载体的示意图；
图8为本发明实施例二提供的带推线的折叠式载体的示意图；
图9为本发明实施例二提供的带套筒的折叠式载体的示意图；
图10为本发明实施例三提供的带拉线的弹出式载体的示意图；
图11为本发明实施例三提供的带凹部的弹出式载体前拉式的示意图；
图12为本发明实施例三提供的带凹部的弹出式载体后拉式的示意图；
图13为本发明实施例三提供的带倾斜式凹槽的弹出式载体后拉式的示意图；
图14为本发明实施例四提供的带套筒的弹出式载体的示意图；
图15为本发明实施例四提供的弹出式载体闭合式收纳的示意图；
图16为本发明实施例四提供的弹出式载体敞开式收纳的示意图；
图17为本发明实施例五提供的带套筒的S型载体的示意图；
图18为本发明实施例五提供的S型载体的示意图；
图19为本发明实施例六提供的喇叭状载体的示意图；
图20本发明实施例六提供的喇叭状载体收入套筒的示意图；
图21为本发明实施例六提供的喇叭状片材载体展开时的俯视图；
图22为本发明实施例六提供的喇叭状片材载体收拢时的俯视图；
图23为本发明实施例六提供的线型载体非对称分布的示意图；
图24为本发明实施例六提供的线型载体中心对称分布的示意图；
图25为本发明实施例六提供的S型载体中心对称分布的示意图；
图26为本发明实施例六提供的换能器的布置示意图；
图27为本发明实施例六提供的穿刺针组件的示意图；
图28为本发明实施例六提供的第三操控机构上的刻度示意图；
图29为本发明实施例一提供的一种推钮式穿刺组件处于锁定位置的示意图；
图30为本发明实施例一提供的一种推钮式穿刺组件解锁时的示意图；
图31为本发明实施例一提供的另一种推钮式穿刺组件处于锁定位置的示意图；
图32为本发明实施例一提供的另一种推钮式穿刺组件解锁时的示意图；
图33为本发明实施例二提供的弹出式穿刺组件蓄能时的示意图。
图34为本发明实施例二提供的弹出式穿刺组件弹出后的示意图。
附图中：
1-导管本体；2-载体；3-换能器单元；4-推线；5-铰接件；6-电缆；7-凹槽；8-拉线；9-凹部；10-套筒结构；11-支撑件；
1-1-工作通道；2-1-载体的第一端；2-2-载体的第二端；
100-长度调节器；101-第三操控机构；102-穿刺针；103-标记；104-操作件；105-限位件；106-止挡件；107-第一弹性件；108-第二弹性件；109-注液接头；110-引导斜面。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且未按比例绘制，仅用以方便、明晰地辅助说明本发明实施例的目的。此外，附图所展示的结构往往是实际结构的一部分。特别的，各附图需要展示的侧重点不同，有时会采用不同的比例。
本发明中所使用的单数形式术语“一”、“一个”以及“该”可包括复数对象，除非内容另外明确指出外。本发明中所使用的术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。本发明中所使用的术语“若干”通常是以包括“至少一个”的含义而进行使用的，除非内容另外明确指出外。本发明中所使用的术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的，除非内容另外明确指出外。此外，术语“第一”、“第二”、“第三”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”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征。
本发明的核心思想在于提供一种超声导引导管及超声导引的穿刺***，以解决现有的进行人体介入手术时器械难以定位以及超声导管占位的问题。
所述超声导引的穿刺***包括可调弯鞘管组件、扩张器组件、穿刺针组件、超声成像组件和控制组件；
所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；
所述扩张器本体包括第二工作通道，所述穿刺针组件的穿刺针能够通过所述第二工作通道以进行穿刺；
所述超声成像组件包括若干载体及设置在所述载体上的换能器单元，所述载体设置在导管本体的远端，并具有收缩位置和打开位置，在所述收缩位置，所述导管本体能够安全通过组织腔道；在所述打开位置，所述载体的至少一部分远离所述导管本体张开；
所述导管本体为所述鞘管本体或所述扩张器本体等；
所述控制组件能够使所述载体从所述收缩位置和所述打开位置中的一者切换到所述收缩位置和所述打开位置中的另一者。
所述超声导引导管包括导管本体、超声成像组件和控制组件；
所述导管本体包括供器械通过的工作通道；
所述超声成像组件包括若干载体及设置在所述载体上的换能器单元，所述载体设置在所述导管本体的远端，并具有收缩位置和打开位置，在所述收缩位置，所述导管本体能够安全通过组织腔道；在所述打开位置，所述载体的至少一部分远离所述导管本体张开；
所述控制组件能够使所述载体从所述收缩位置和所述打开位置中的一者切换到所述收缩位置和所述打开位置中的另一者。
如此配置，通过将超声成像组件集成至所述导管本体上，能够在进行人体介入手术时，提供器械范围内的可视化组织结构，从而更好地***械的操作点，指导手术者操作，减小施术的风险，便于手术顺利进行。并且，由于超声成像组件集成至所述导管本体上，需要进行房间隔穿刺手术时，不需要多次交换房间隔穿刺***、穿刺针、导丝及鞘管***等器械，极大地简化了手术步骤，降低了不必要的穿刺部位的不良事件风险。
实施例一
请参照图1-图3，所述超声导引导管包括导管本体1、超声成像组件和控制组件；
所述导管本体1包括供器械通过的工作通道1-1；
所述超声成像组件包括若干载体2及设置在所述载体2上的换能器单元3，所述载体2设置在所述导管本体1的远端，并具有收缩位置和打开位置，在所述收缩位置，所述导管本体1能够安全通过组织腔道，如图2所示；在所述打开位置，所述载体2的至少一部分远离所述导管本体1张开，如图3所示；
所述控制组件能够使所述载体2从所述收缩位置和所述打开位置中的一者切换到所述收缩位置和所述打开位置中的另一者。
本文中“近端”和“远端”的定义为：“近端”通常指该医疗器械在正常操作过程中靠近操作者的一端，而“远端”通常是指该医疗器械在正常操作过程中首先进入患者体内的一端。需要理解的是，所述工作通道1-1优选的可不仅限于导引导丝通过，还可允许除导丝之外的其它器械通过。
具体的，所述超声成像组件用于发射并接受超声信号，分析并输出影像。根据不同换能器阵列回传各自单一超声信号，主机可以进行图像处理，根据图形的内容，将相同的部分进行拼合，然后输出整合后的大视角下的图像，为操作提供更大视野范围，本实施例中超声成像组件可以放置于不同的治疗目的主机设备中，并与其兼容。
所述超声成像组件包括若干载体2以及位于所述的载体2上的换能器单元3，所述载体2作为所述换能器单元3的安装平台，可以安装在相应的导管本体1的远端上，在施术过程中载体2跟随所述导管本体1一起进入腔道内进行手术。所述换能器单元3布置于鞘管的远端的载体2上，电缆6在所述导管本体1的远端与所述载体2上的换能器单元3相连，在所述导管本体1近端与所述控制组件内的接线相连接，然后通过所述控制组件接线转接于超声***的主机上。
进一步的，所述载体2至少包括第一端2-1和第二端2-2，所述第一端2-1与所述导管本体1连接，所述第二端2-2能够位于远离所述导管本体1的所述打开位置。
更进一步的，所述控制组件包括扩张机构，所述扩张机构与所述第二端连接，所述扩张机构能够使所述载体2从所述收缩位置向预设的所述打开位置切换。
具体的，请参照图2-图5，所述载体2的所述第一端2-1与所述导管本体1铰接，所述扩张机构包括推线4，在所述收缩位置，所述载体2贴合于所述导管本体1的外壁上，通过推动所述推线4能够使所述载体2的所述第二端相对所述导管本体1向预设的所述打开位置转动。所述打开位置可根据成像视野的需要相对所述导管本体1的轴线打开不同的角度。所述推线4设置在所述导管本体1内，通过推动所述推线4实现所述载体2的位置切换。在所述超声导引导管需要从组织腔体中撤出时，所述推线4可拉动所述载体2的所述第二端，使所述载体2贴靠于所述导管本体1上。
较佳的，所述载体2的第一端2-1通过一铰接件5可枢转地安装在所述导管本体1上，所述铰接件5露出于所述导管本体1的部分可与所述载体2的所述第一端2-1铰接，使所述载体2能绕所述铰接件5进行旋转。
较佳的，所述载体2包括枢转部，所述载体2的第二端2-2能够通过所述枢转部旋转远离所述导管本体1到达预设的所述打开位置，所述载体2的第二端2-2与所述枢转部一体形成。
进一步较佳的，所述载体2的远端和近端的端部表面均为弧形，以在超声导引导管穿过腔道时减少阻力、减少组织损伤。优选的，所述载体2的第一端2-1为远端，所述载体2的第二端2-2为近端。
本实施例中，所述超声成像组件的电缆6的至少一部分埋设于所述载体2内，并与所述换能器单元3电连接，从所述载体2引出的所述电缆6的至少一部分埋设于所述导管本体1上，其近端与接线器电连接。优选的，所述接线器位于所述控制组件(如导管控制手柄)上，通过所述控制组件可将所述接线器连接于超声主机模块上。
较佳的，所述电缆6为柔性电缆，在所述收缩位置时，连接位于所述载体2与所述导管主体内的电缆6的部分位于所述载体2与所述导管本体1之 间，在所述载体2绕所述铰接件5进行旋转的过程中，所述柔性电缆6的该部分能翻转一定角度，保证所述换能器单元3与主机的连接，如图3、4所示。
本实施例中，所述载体2可以通过不同的形式进行安装，可以是单块载体2，也可以是多块载体2组合。使用时，翻转的载体2可以提供多个不同角度下的影像，多个不同的载体2可以由操作手柄内相应的推线4进行控制，产生不同方位下的详细影像效果。
较佳的，请参照图6，所述导管本体1的外壁上还设置有用于容纳所述载体2的凹槽7。当所述超声成像组件不需要使用时，可将所述超声成像组件收纳进所述凹槽7内，使得所述超声成像组件的载体2及所述铰接件5不会突出于所述导管本体1的表面，从而减少所述导管本体1的凸起，使所述超声导引导管的通过性能更佳。
进一步较佳的，请参照图7，所述导管本体的外壁上还设置有用于容纳所述载体的凹槽7，所述凹槽7中设置有凹部9，所述凹部9用于容纳所述第二端，所述推线4由所述凹部9的表面伸出所述凹槽7并与所述第二端连接，以实现更好的收纳效果。
实施例二
请参照图8，与实施例一不同的是，本实施例中，所述载体2至少包括第一端2-1和第二端2-2，在所述第一端2-1和所述第二端2-2之间设置折叠区，所述第一端2-1与所述导管本体1连接，所述控制组件能够使所述载体2在所述折叠区远离所述导管本体1向预设的所述打开位置移动或使所述载体2在所述折叠区从远离所述导管本体1的所述打开位置向所述收缩位置移动。
本实施例中，所述控制组件可以是推线4，也可以是套筒结构10，请参照图9，所述载体2为折叠式载体，所述载体2的第二端2-2及第一端2-1分别与所述套筒结构10及所述导管本体1连接，所述套筒结构10能够移动地设置在所述导管本体1上，通过驱使所述套筒结构10相对所述导管本体1移动能够使所述载体2在所述折叠区远离所述导管本体1向预设的所述打开位置移动或使所述载体2在所述折叠区从远离所述导管本体1的所述打开位置向所述收缩位置移动。
较佳的，所述载体2的第一端2-1为远端，所述载体2的第二端2-2为近端。
实施例三
请参照图10，与前述实施例不同的是，本实施例中，所述载体2相对所述导管本体1在不受外力的情况下能够以最大程度张开到所述打开位置。
具体的，所述控制组件包括收缩机构，所述收缩机构能够使所述载体2从最大程度张开的所述打开位置切换到所述收缩位置。
本实施例中，所述收缩机构包括拉线8，所述拉线8与所述第二端2-2连接，通过拉动所述拉线8能够使所述第二端2-2从所述打开位置切换到所述收 缩位置。
较佳的，请参照图11-图12，所述导管本体1的外壁上还设置有用于容纳所述载体2的凹槽7，所述凹槽7中设置有凹部9，所述凹部9用于容纳所述第二端2-2，所述拉线8由所述凹部9的表面伸出所述凹槽7并与所述第二端2-2连接。当所述拉线8不再从所述导管本体1上的凹槽7的侧边伸出，而是从凹槽7的底部伸出时，同时整个凹槽7内有一较深区域(即凹部9)，该区域位于拉线8的伸出处，使载体收拢的更好，由此衍生出两种载体2收纳的方式。请参照图11，所述拉线8与所述载体2的近端(图11所示为第二端2-2)连接，通过拉动所述拉线8以使所述载体2的近端向靠近所述导管本体1的表面移动；或者，请参照图12，所述拉线8与所述载体2的远端(图12所示为第二端2-2)连接，通过拉动所述拉线8以使所述载体2的远端向靠近所述导管本体1的表面移动。
或者，请参照图13，所述凹槽7为倾斜式凹槽，且所述凹槽7的深度朝向所述第二端2-2逐渐增大，形成凹部，也可以使载体获得更好地收拢效果。
实施例四
请参照图14，与前述实施例不同的是，本实施例中，所述收缩机构包括套筒结构10，所述套筒结构10能够移动地设置在所述导管本体1上，通过驱使所述套筒结构10相对所述导管本体1移动能够使所述第二端2-2从所述打开位置切换到所述收缩位置。
较佳的，所述套筒结构10的内壁或所述导管本体1的外壁上设置有若干用于容纳所述载体2的收纳槽，当所述套筒将所述载体2收回时，所述载体2刚好卡入所述套筒结构10或所述导管本体1的收纳槽内。
基于上述实施例三及实施例四，本申请还衍生出两种载体2(载体可选用具有弹性材料，例如弹簧片，镍钛合金，聚合物)收纳的方式。载体2包括枢转部，所述枢转部设置在所述第一端2-1和所述第二端2-2之间，请参照图15，通过所述枢转部，所述载体2的所述第二端2-2朝向靠近所述载体2的所述第一端2-1转动并改变载体2相对导管本体1的张开角度。或者，请参照图16，通过所述枢转部，所述载体2的所述第二端2-2朝向远离所述载体2的所述第一端2-1转动并改变载体2相对导管本体1的张开角度，这两种载体2收纳的方式同时适用于拉线8或者套筒结构10。
同理，所述导管本体1的外壁上也可以设置用于容纳所述载体2的凹槽。
实施例五
请参照图17-图18，与上述实施例不同的是，本实施例中，所述载体2呈S形，当所述载体2位于所述打开位置时，所述载体2的位于所述折叠区两侧的部分沿所述导管本体1的轴向错位且该部分上的换能器单元3的朝向一致。采用S型载体替代直线型载体，可以更多的换能器，来获得加强的超声效果。分别在S型载体的所述折叠区两侧的部分的内侧和外侧安装所述换 能器单元3，在S型载体被推至折叠后，所述S型载体的内外两侧的换能器单元3经由折叠后能有一致的朝向，内外两侧都可以安装所述换能器单元3，并且同时向同一方向进行超声波的发射，从而获得更高超声波发射密度和成像效果。
实施例六
请参照图19，与上述实施例不同的是，本实施例中，所述载体2为能够移动地设置于导管远端端头的喇叭状结构且能够收拢地设置在所述导管本体1内，所述超声成像组件还包括用于支撑所述载体2的支撑件11，所述支撑件11位于所述导管本体1内且能够通过所述控制组件的驱使相对所述导管本体1移动以使所述第二端露出所述导管本体1后呈喇叭状展开，或者通过所述控制组件的驱使相对所述导管本体1移动以使所述第二端能够收拢地设置在所述导管本体1内。
可替换的，所述载体2为设置于导管远端端头的喇叭状结构且能够收拢地设置在所述套筒结构10内，请参照图19-21，所述载体2为喇叭状结构，所述超声成像组件还包括用于支撑的支撑件11，所述支撑件11之间通过柔性材料连接形成扇区，按扇区给柔性材料上设置收拢折痕，布置电路并放置换能器。支撑件11能够使所述载体2相对所述导管本体1在不受外力的情况下以最大程度引导支撑件11间的柔性材料张开到所述打开位置；当所述套筒结构10向所述导管本体1的远端移动时，柔性材料依照设置的折痕进行折叠收拢，使所述载体2能够收拢地设置在所述套筒结构10内。柔性材料上设置的换能器能形成单个换能器阵列，所有扇形区域的超声换能器能组成更大的换能器阵列，通过超声相控阵技术，激发和接受不同方向的超声，通过图像算法实现实时成像，成像区域与贴面的展开几何形状相关，可以看到导管本体1远端前面的组织结构。
本实施例中，所示支撑件11为高弹性线材，如弹簧钢、镍钛金属、钛合金等，所述支撑件11包括多个，并通过环形固定件进行固定，以增强所述支撑件11之间的连接强度。
较佳的优化实施例，参照图21-图22，可用预定型的高弹片材(如弹簧钢、镍钛金属、钛合金等)代替所述喇叭状结构载体2内的线材，放置固定环增强片材间的连接强度和片材与所述导管本体1的连接强度，取消原本在线材上按扇区折叠的柔性材料，将柔性电路，换能器直接布置在高弹的片材上，此方式可以应用于对空间结构有一定要求的器械。当所述套筒结构10向所述导管本体1的远端移动时，高弹线材被所述套筒结构10收拢，使所述载体2能够收拢地设置在所述套筒结构10内。通过调整所述套筒结构10与所述载体2的相对位置，可以控制载体的张开程度。
在所述的所有的实施例中，所述载体2可以是单个，也可以是多个。所述载体2的分布可以偏置于所述导管本体1的一侧，如图23，也可以是绕所 述导管本体1的中心对称分布，如图24-图25，本申请对此不作限制，考虑实际的容纳能力和超声波覆盖重合情况，所述载体2的数量不大于8个。
在所述的实施例中，一个换能器单元3可以包括单个换能器或者是多个换能器阵列，如图26。所述换能器可以安装在载体2的外侧或者内侧，单个载体2上的多个换能器之间的间隔d在0.2λ-1.2λ之间(λ为换能器方射的超声波波长)。换能器组成阵列时，可以是由单个载体2上的多个换能器组成阵列，也可以是由多个载体2上的不同换能器组成阵列。多个换能器可以进行分组，单个组内的多个换能器可以同发同收，组内换能器就形成单一换能器的效果，特殊情况下，当所有换能器都进行同发同收时，整个换能器阵列就形成单一换能器的效果。超声***的主机通过电缆6对换能器进行的控制，形成换能器阵列的发射特定顺序超声波，到达相控阵的效果，增强特定区域的超声成像效果。
另一方面，本发明提供了一种超声导引的穿刺***，包括如上所述的超声导引导管。
进一步的，所述穿刺***还包括可调弯鞘管组件、扩张器组件和穿刺针组件；
所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；
所述扩张器本体包括第二工作通道，所述穿刺针组件的穿刺针能够通过所述第二工作通道以进行穿刺；所述扩张器本体与所述扩张器组件的第二操控机构连接；
所述导管本体为所述鞘管本体或所述扩张器本体。
本实施例中，所述扩张器本体为中空管状结构，内部具有可供所述穿刺针进出的第二工作通道。较佳的，所述扩张器本体的远端具有一定锥度，便于穿过房间隔。
请参照图27，所述穿刺***还包括长度调节器100，所述穿刺针组件包括第三操控机构101，所述长度调节器100设置于所述第三操控机构101与所述扩张器组件的第二操控机构(图中未示出)之间，通过调节所述长度调节器100调节所述第二操控机构与所述第三操控机构101之间的间距，进而调节所述穿刺针102伸出所述扩张器本体的长度。通过调节所述长度调节器100与所述第三操控机构101之间的相对位置能够调节所述第三操控机构101与所述第二操控机构之间的间距，进而调节所述穿刺针102伸出所述扩张器本体的长度；或者，通过调节所述长度调节器100与所述第二操控机构之间的相对位置能够调节所述第三操控机构101与所述第二操控机构之间的间距，进而调节所述穿刺针102伸出所述扩张器本体的长度。
通过设置所述长度调节器100，解决了传统的穿刺针102在X射线影像下伸出的长度较难判断，导致长度控制难度较大，从而增加了刺破或损伤心 肌或周围组织甚至造成心包填塞风险的问题。
所述长度调节器100与所述第二操控机构或所述第三操控机构101之间相对运动的方式包括但不限于紧配合移动，卡销插拔，螺纹旋转等。
进一步的，所述长度调节器100与所述第二操控机构及所述第三操控机构101中的一者螺纹连接，通过旋转所述长度调节器100以调节所述穿刺针102伸出所述扩张器本体的长度。本实施例中，所述长度调节器器100与所述第三操控机构101螺纹连接。
较佳的，请参照图28，所述长度调节器100的螺纹处设置有一标记103，所述第二操控机构与所述第三操控机构101中的所述一者的壳体上对应设置有一刻度，通过观察所述标记103对准的刻度值以获取所述穿刺针102伸出所述扩张器本体的最大长度。在对所述长度调节器100进行旋转时，通过观察所述长度调节器100上的标记103对准的刻度值，在不进行穿刺针102伸出检查时就能判断出所述穿刺针102伸出的具体长度。例如，当所述标记对准刻度零点时，表示所述穿刺针102伸出至最大行程时，所述穿刺针102的远端与所述扩张器本体的远端对齐。例如，当所述标记对准刻度“3”时，表示所述穿刺针102伸出至最大行程时，所述穿刺针102超出所述扩张器本体的远端3个单位。
可选的，所述长度调节器100也可以是连接在所述第二操控机构与所述第三操控机构101之间的可伸缩机构，“可伸缩机构”属于公知常识，在此不做过多描述。
可选的，所述第三操控机构101还包括操作件104和导向槽，所述操作件104位于所述导向槽内且能够在所述导向槽内移动以驱使所述穿刺针102伸缩。
可选的，所述第三操控机构101还包括操作件和导向槽，所述操作件位于所述导向槽内且能够在所述导向槽内移动以锁定或解锁所述穿刺针的运动。
实施例一
请参照图29-图32，所述操作件104为能够移动地设置在所述第三操控机构101上的推钮，所述推钮与所述穿刺针102具有上下的活动连接，在按压所述推钮的过程中，所述穿刺针102能够保持与所述扩张器本体的同轴。所述第三操控机构101还包括限位结构，所述限位结构包括设置于所述操作件104上的限位件105及与所述限位件105配合的止挡件106，所述限位件105与所述止挡件106配合以在锁定位置锁定所述穿刺针102。
通过按压推钮能够使限位件105脱离止挡件106，以解锁所述穿刺针102，然后继续推动推钮能够带动所述穿刺针102沿其推送方向移动，即控制所述穿刺针102的伸出或缩回。
较佳的，通过调整所述导向槽的长度能够调整所述操作件104沿所述穿 刺针102的推送方向的移动量，进而调整所述穿刺针102的推送量。
作为本实施例中第一个较佳的示例，请参照图29-30，所述推钮与所述第三操纵机构上对应设置有所述限位件105及所述止挡件106。锁定位置下，所述止挡件106相对所述限位件105靠近所述穿刺针102的远端，且所述限位件105与所述止挡件106相互抵接，并限制所述穿刺针102动作；当下压所述推钮时，所述限位件105在竖向上错开所述止挡件106，即所述止挡件106不再位于所述限位件105的行程上，相当于对所述穿刺针102进行解锁，此时可释放对所述推钮的下压力，通过驱使所述推钮沿所述穿刺针102的推送方向移动能够带动所述穿刺针102沿其推送方向移动。
作为本实施例中第二个较佳的示例，请参照图31-32，所述推钮与所述第三操纵机构上对应设置有所述限位件105及所述止挡件106。锁定位置下，所述止挡件106相对所述限位件105靠近所述穿刺针102的远端，且所述限位件105的远端与所述止挡件106相互扣合，并限制所述穿刺针102动作；当下压所述推钮时，所述限位件105与所述止挡件106相互分离，即所述止挡件106不再位于所述限位件105的行程上，相当于对所述穿刺针102进行解锁，此时可释放对所述推钮的下压力，通过驱使所述推钮沿所述穿刺针102的推送方向移动能够带动所述穿刺针102沿其推送方向移动。
较佳的，所述限位结构还包括第一弹性件107，所述第一弹性件107能够向所述操作件104施加力，以在所述锁定位置，使所述限位件105与所述止挡件106保持相互抵接。本实施例中，所述第一弹性件107位于所述推钮的底部并向所述推钮施加一个竖直向上的力，用于保证所述推钮在意外受力的情况下，所述限位件105能够被所述止挡件106所阻挡，以防止所述穿刺针102意外伸出。所述第一弹性件107例如为弹簧、弹片等，本申请对此不作限制。
较佳的，所述限位件105与所述止挡件106中的至少一者包括引导斜面110，在将所述穿刺针102设置在所述锁定位置的过程中，通过所述引导斜面110的引导，所述限位件105与所述止挡件106能够设置在所述锁定位置，进而锁定所述穿刺针102。
较佳的，所述穿刺针102的近端设置注液接头109，通过拉动所述注液接头109能够将所述止挡件106与所述限位件105设置在所述锁定位置。
实施例二
上述实施例一的不同之处在于，请参照图33和图34，本实施例中，所述止挡件106设置在所述穿刺针102上，所述操作件104能够在所述导向槽内在竖向上进行移动，如通过按压的方式，且所述操作件104包括供所述止挡件106通过的通道，所述限位件105可以理解为所述通道的下部区域。锁定位置下，所述止挡件106相对所述操作件104靠近所述穿刺针102的近端，且所述止挡件106与所述限位件105相互抵接，并限制所述穿刺针102动作； 当下压所述操作件104时，所述限位件105在竖向上错开所述止挡件106，即所述限位件105不再位于止挡件106的行程上，以便所述止挡件106能够通过所述通道，进而便于所述穿刺针102的远端伸出所述扩张器本体。
较佳的，所述穿刺针102组件包括第三操控机构101，所述第三操控机构101还包括蓄能组件，所述蓄能组件能够作用于所述穿刺针102，以将所述穿刺针102的远端推出所述扩张器本体。通过设置所述蓄能装置能够将积蓄的能量转换为所述穿刺针102的穿刺速度，在所述穿刺针102穿刺时提高所述穿刺针102的穿刺速度，从而不需要人为地将房间隔顶出帐篷症，减小穿刺的风险。
进一步较佳的，所述第三操控机构101的蓄能组件包括第二弹性件108，如图33-34所示，所述止挡件106设置在所述穿刺针102上，所述第二弹性件108的一端与所述止挡件106相抵接，另一端与所述第三操控机构101抵接；所述穿刺针102处于锁定位置时，所述限位件105与所述止挡件106相配合，使所述第二弹性件108处于压缩状态，限制所述穿刺针102的运动。所述第二弹性件108起蓄能作用，用于将所述穿刺针102推出，其结构包括但不限于弹簧、气缸、气囊等。以弹簧为例，如图33所示，使用前将所述穿刺针102后拉，所述弹簧被压缩，同时所述操作件104上的限位件105对所述止挡件106造成阻挡，所述穿刺针102处于锁定状态，蓄能完成。如图34所示，使用时下压所述操作件104，所述限位件105在竖向上错开所述止挡件106，所述穿刺针102被释放，在所述弹簧的作用下，以较高速度伸出顶在房间隔上的扩张器，刺破房间隔，穿刺完成。
较佳的，所述限位结构还包括第一弹性件107，所述第一弹性件107能够向所述操作件104施加力，以在所述锁定位置，使所述限位件105与所述止挡件106保持相互抵接。本实施例中，所述第一弹性件107位于所述推钮的底部并向所述推钮施加一个竖直向上的力，用于保证所述推钮在第一弹性件107的作用下，所述止挡件106能够被所述限位件105所阻挡，以防止所述穿刺针102意外伸出。所述第一弹性件107例如为弹簧、弹片等，本申请对此不作限制。
较佳的，所述限位件105与所述止挡件106中的至少一者包括引导斜面110，在将所述穿刺针102设置在所述锁定位置的过程中，通过所述引导斜面110的引导，所述限位件105与所述止挡件106能够设置在所述锁定位置，进而锁定所述穿刺针102。
较佳的，所述穿刺针102的近端设置注液接头109，通过拉动所述注液接头109能够将所述止挡件106与所述限位件105设置在所述锁定位置。
综上，本发明提供了一种超声导引导管，通过将超声成像组件集成至所述导管本体上，能够提供器械范围内的可视化组织结构，从而更好地定位出穿刺点，指导手术者操作，减小施术的风险，便于手术顺利进行。基于此， 本发明还提供了一种超声导引的穿刺***，通过在扩张器组件的第二操控机构与穿刺针组件的第三操控机构之间增设通过设置长度调节器，解决了传统的穿刺针在X射线影像下伸出的长度较难判断，导致长度控制难度较大，从而增加了刺破或损伤心肌或周围组织甚至造成心包填塞风险的问题。
上述仅为本发明的优选实施例而已，并不对本发明起到任何限制作用。任何所属技术领域的技术人员，在不脱离本发明的技术方案的范围内，对本发明揭露的技术方案和技术内容做任何形式的等同替换或修改等变动，均属未脱离本发明的技术方案的内容，仍属于本发明的保护范围之内。

Claims (33)

  1. 一种超声导引的穿刺***，其特征在于，包括可调弯鞘管组件、扩张器组件、穿刺针组件、超声成像组件和控制组件；
    所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；
    所述扩张器本体包括第二工作通道，所述穿刺针组件的穿刺针能够通过所述第二工作通道以进行穿刺；
    所述超声成像组件包括至少一个载体及设置在所述载体上的换能器单元，所述载体设置在导管本体的远端，并具有收缩位置和打开位置，在所述收缩位置，所述导管本体能够安全通过组织腔道；在所述打开位置，所述载体的至少一部分远离所述导管本体张开；
    所述导管本体为所述鞘管本体或所述扩张器本体；
    所述控制组件能够使所述载体从所述收缩位置和所述打开位置中的一者切换到所述收缩位置和所述打开位置中的另一者。
  2. 一种超声导引导管，其特征在于，包括导管本体、超声成像组件和控制组件；
    所述导管本体包括供器械通过的工作通道；
    所述超声成像组件包括至少一个载体及设置在所述载体上的换能器单元，所述载体设置在所述导管本体的远端，并具有收缩位置和打开位置，在所述收缩位置，所述导管本体能够安全通过组织腔道；在所述打开位置，所述载体的至少一部分远离所述导管本体张开；
    所述控制组件能够使所述载体从所述收缩位置和所述打开位置中的一者切换到所述收缩位置和所述打开位置中的另一者。
  3. 如权利要求2所述的超声导引导管，其特征在于，所述载体至少包括第一端和第二端，所述第一端与所述导管本体连接，所述第二端能够位于远离所述导管本体的所述打开位置。
  4. 如权利要求3所述的超声导引导管，其特征在于，所述控制组件包括扩张机构，所述扩张机构与所述第二端连接，所述扩张机构能够使所述载体从所述收缩位置向预设的所述打开位置切换。
  5. 如权利要求4所述的超声导引导管，其特征在于，所述载体的所述第一端与所述导管本体铰接，所述扩张机构包括推线，所述载体贴合于所述导管本体的外壁上，通过推动所述推线能够使所述载体的所述第二端相对所述导管本体向预设的所述打开位置转动。
  6. 如权利要求2所述的超声导引导管，其特征在于，所述载体至少包括第一端和第二端，在所述第一端和所述第二端之间设置折叠区，所述第一端与所述导管本体连接，所述控制组件能够使所述载体在所述折叠区远离所述 导管本体向预设的所述打开位置移动或使所述载体在所述折叠区从远离所述导管本体的所述打开位置向所述收缩位置移动。
  7. 如权利要求3所述的超声导引导管，其特征在于，所述载体相对所述导管本体在不受外力的情况下能够以最大程度张开到所述打开位置。
  8. 如权利要求7所述的超声导引导管，其特征在于，所述控制组件包括收缩机构，所述收缩机构能够使所述载体从最大程度张开的所述打开位置切换到所述收缩位置。
  9. 如权利要求8所述的超声导引导管，其特征在于，所述收缩机构包括拉线，所述拉线与所述第二端连接，通过拉动所述拉线能够使所述第二端从所述打开位置切换到所述收缩位置；或
    所述收缩机构包括套筒结构，所述套筒结构能够移动地设置在所述导管本体上，通过驱使所述套筒结构相对所述导管本体移动能够使所述第二端从所述打开位置切换到所述收缩位置。
  10. 如权利要求3-9中任一项所述的超声导引导管，其特征在于，所述导管本体的外壁上还设置有用于容纳所述载体的凹槽。
  11. 如权利要求5所述的超声导引导管，其特征在于，所述导管本体的外壁上还设置有用于容纳所述载体的凹槽，所述凹槽中设置有凹部，所述凹部用于容纳所述第二端，所述推线由所述凹部的表面伸出所述凹槽并与所述第二端连接。
  12. 如权利要求9所述的超声导引导管，其特征在于，所述导管本体的外壁上还设置有用于容纳所述载体的凹槽，所述凹槽中设置有凹部，所述凹部用于容纳所述第二端；所述拉线通过所述凹部的表面伸出所述凹槽与所述第二端连接。
  13. 如权利要求3-9、11、12中任一项所述的超声导引导管，其特征在于，所述载体包括枢转部，所述载体能够通过所述枢转部旋转到达预设的所述打开位置，所述第二端与所述枢转部一体形成。
  14. 如权利要求13所述的超声导引导管，其特征在于，所述载体与所述导管本体一体形成，用于连接所述换能器单元的电缆在所述载体和所述导管本体之间无外露部分。
  15. 如权利要求6所述的超声导引导管，其特征在于，所述载体呈S形，当所述载***于所述打开位置时，所述载体的位于所述折叠区两侧的部分沿所述导管本体的轴向错位且该部分上的换能器单元的朝向一致。
  16. 如权利要求3所述的超声导引导管，其特征在于，所述载体为喇叭状结构且能够收拢地设置在所述导管本体内，所述超声成像组件还包括用于支撑所述载体的支撑件，所述支撑件位于所述导管本体内且能够通过所述控制组件的驱使相对所述导管本体移动以使所述第二端露出所述导管本体后呈喇叭状展开。
  17. 如权利要求9所述的超声导引导管，其特征在于，所述载体为喇叭状结构，所述超声成像组件还包括用于支撑所述载体的支撑件，所述支撑件能够使所述载体相对所述导管本体在不受外力的情况下以最大程度张开到所述打开位置；当所述套筒结构向所述导管本体的远端移动时，所述载体能够收拢地设置在所述套筒结构内。
  18. 如权利要求2所述的超声导引导管，其特征在于，所述载体绕所述导管本体的中心对称分布。
  19. 如权利要求2所述的超声导引导管，其特征在于，所述换能器单元中的至少一个换能器能够独立控制。
  20. 一种超声导引的穿刺***，其特征在于，包括如权利要求2-19中任一项所述的超声导引导管。
  21. 如权利要求20所述的超声导引的穿刺***，其特征在于，所述穿刺***还包括可调弯鞘管组件、扩张器组件和穿刺针组件；
    所述可调弯鞘管组件包括鞘管本体，所述鞘管本体包括第一工作通道，所述扩张器组件的扩张器本体能够通过所述第一工作通道；
    所述扩张器本体包括第二工作通道，所述穿刺针组件的穿刺针能够通过所述第二工作通道以进行穿刺；所述扩张器本体与所述扩张器组件的第二操控机构连接；
    所述导管本体为所述鞘管本体或所述扩张器本体。
  22. 如权利要求1或21所述的超声导引的穿刺***，其特征在于，所述穿刺***还包括长度调节器，所述穿刺针组件包括第三操控机构，所述长度调节器设置于所述第三操控机构与所述扩张器组件的第二操控机构之间，通过调节所述长度调节器调节所述第二操控机构与所述第三操控机构之间的间距，进而调节所述穿刺针伸出所述扩张器本体的长度。
  23. 如权利要求22所述的超声导引的穿刺***，其特征在于，所述长度调节器与所述第二操控机构及所述第三操控机构中的一者螺纹连接，通过旋转所述长度调节器以调节所述穿刺针伸出所述扩张器本体的长度。
  24. 如权利要求23所述的超声导引的穿刺***，其特征在于，所述长度调节器的螺纹处设置有一标记，所述第二操控机构与所述第三操控机构中的所述一者的壳体上对应设置一刻度，通过观察所述标记对准的刻度值以获取所述穿刺针伸出所述扩张器本体的最大长度。
  25. 如权利要求22所述的超声导引的穿刺***，其特征在于，所述第三操控机构还包括操作件和导向槽，所述操作件位于所述导向槽内且能够在所述导向槽内移动以驱使所述穿刺针伸缩。
  26. 如权利要求1或21所述的超声导引的穿刺***，其特征在于，所述穿刺针组件包括第三操控机构，所述第三操控机构还包括蓄能组件，所述蓄能组件能够作用于所述穿刺针，以将所述穿刺针的远端推出所述扩张器本体。
  27. 如权利要求26所述的超声导引的穿刺***，其特征在于，所述第三操控机构还包括操作件和导向槽，所述操作件位于所述导向槽内且能够在所述导向槽内移动以锁定或解锁所述穿刺针的运动。
  28. 如权利要求25或27所述的超声导引的穿刺***，其特征在于，所述第三操控机构还包括限位结构，所述限位结构包括设置于所述操作件上的限位件及与所述限位件配合的止挡件，所述限位件与所述止挡件配合以在锁定位置锁定所述穿刺针。
  29. 如权利要求28所述的超声导引的穿刺***，其特征在于，所述限位结构还包括第一弹性件，所述第一弹性件能够向所述操作件施加力，以在所述锁定位置，使所述限位件与所述止挡件保持相互抵接。
  30. 如权利要求28所述的超声导引的穿刺***，其特征在于，所述限位件与所述止挡件中的至少一者包括引导斜面，在将所述穿刺针设置在所述锁定位置的过程中，通过所述引导斜面的引导，所述限位件与所述止挡件能够设置在所述锁定位置，进而锁定所述穿刺针。
  31. 如权利要求28所述的超声导引的穿刺***，其特征在于，所述操作件包括供所述止挡件通过的通道，在需要组织穿刺时，所述止挡件能够通过所述通道，以便于所述穿刺针的远端伸出所述扩张器本体。
  32. 如权利要求28所述的超声导引的穿刺***，其特征在于，所述第三操控机构的蓄能组件包括第二弹性件，所述止挡件设置在所述穿刺针上，所述第二弹性件的一端与所述止挡件相抵接，另一端与所述第三操控机构抵接；所述穿刺针处于锁定位置时，所述限位件与所述止挡件相配合，使所述第二弹性件处于压缩状态，限制所述穿刺针的运动。
  33. 如权利要求29-32中任一项所述的超声导引的穿刺***，其特征在于，所述穿刺针的近端设置注液接头，通过拉动所述注液接头能够将所述止挡件与所述限位件设置在所述锁定位置。
PCT/CN2023/073314 2022-11-24 2023-01-20 超声导引导管及超声导引的穿刺*** WO2024108761A1 (zh)

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