CN115568919A - Ultrasound guide catheter and ultrasound guided puncture system - Google Patents

Ultrasound guide catheter and ultrasound guided puncture system Download PDF

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Publication number
CN115568919A
CN115568919A CN202211478594.8A CN202211478594A CN115568919A CN 115568919 A CN115568919 A CN 115568919A CN 202211478594 A CN202211478594 A CN 202211478594A CN 115568919 A CN115568919 A CN 115568919A
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Prior art keywords
carrier
catheter
catheter body
ultrasound
puncture needle
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Chinese (zh)
Inventor
杨俊�
李雷
崔铁军
史胜凤
薛卫
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Shanghai Antaike Medical Technology Co ltd
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Shanghai Antaike Medical Technology Co ltd
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Priority to CN202211478594.8A priority Critical patent/CN115568919A/en
Publication of CN115568919A publication Critical patent/CN115568919A/en
Priority to PCT/CN2023/073314 priority patent/WO2024108761A1/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3439Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3494Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A61B17/3496Protecting sleeves or inner probes; Retractable tips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/085Detecting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445Details of catheter construction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00778Operations on blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • A61B2017/3413Needle locating or guiding means guided by ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454Details of tips

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Vascular Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

The invention provides an ultrasonic guide catheter and an ultrasonic guide puncture system, wherein the puncture system comprises an adjustable bent sheath tube assembly, an expander assembly, a puncture needle assembly, an ultrasonic imaging assembly and a control assembly; the adjustable bending sheath tube assembly comprises a sheath tube body, and the sheath tube body comprises a first working channel for the dilator body of the dilator assembly to pass through; the dilator body comprises a second working channel for the puncture needle of the puncture needle assembly to pass through; the ultrasonic imaging assembly comprises a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the far end of the catheter body and have a contraction position and an opening position, and in the contraction position, the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier flares away from the catheter body; the control assembly is capable of moving the carrier between the retracted position and the open position. The invention solves the problems that the existing instruments are difficult to position and the ultrasonic catheter occupies space when the human body intervention operation is carried out.

Description

Ultrasonic guide catheter and ultrasonic guide puncture system
Technical Field
The invention relates to the technical field of medical instruments, in particular to an ultrasonic guide catheter and an ultrasonic guide puncture system.
Background
The percutaneous approach catheter normally cannot proceed directly to the left atrium. Although the left atrium can be accessed retrograde through the two turns of the aortic and mitral valves, the catheter is cumbersome to operate. Therefore, in clinical practice, the left atrium intervention operation usually involves accessing the right atrium of the heart from the femoral vein, puncturing the interatrial septum between the right atrium and the left atrium, placing a sheath as a channel, and delivering the instrument into the left atrium through the sheath.
The existing commonly used left atrial access establishment method is that after femoral vein puncture is completed, an interatrial puncture system tube with a fixed head end shape is sent into the right atrium through a guide wire, the guide wire is removed and then sent into an interatrial puncture needle, generally, after the position of an oval is found under X-rays, the puncture needle is used for puncture, then a puncture sheath penetrates through a puncture point and enters the left atrium, after the puncture is completed, the puncture needle is withdrawn, the guide wire penetrates through the puncture sheath again and is sent into the left atrium, then the puncture sheath is withdrawn out of the body, and finally, the interatrial puncture system or other instruments used for left atrial interventional surgery are sent into the left atrium along the guide wire. During the whole process of establishing the left atrial pathway, various instruments need to be exchanged for many times, the guide wire is used for guiding to enable the interatrial septum puncture system to be in place, then the guide wire is withdrawn, the interatrial septum puncture needle is used for puncturing the interatrial septum, then the puncture needle is withdrawn, the guide wire is sent to pass through the interatrial septum and then is withdrawn out of the interatrial puncture system, and finally the guide wire is used for guiding to enable the sheath canal pathway to be in place. The whole path establishing process relates to instruments such as an interatrial septum puncture system, an interatrial septum puncture needle, a guide wire, a sheath system and the like, the steps are complicated, multiple times of radiography is needed, and meanwhile, the risk of unnecessary adverse events at the puncture part is increased.
In addition, in practical operation, the doctor needs to determine the position of the instrument according to the hand feeling feedback of the instrument in the patient and the planar image of the X-ray. The physiological structures of different patients are different, the direction of the puncture needle under the X-ray plane image is difficult to judge, the difficulty is high during puncture, and the risk is higher. Meanwhile, before and after puncture, an operator needs to pay attention to the state of the puncture needle, and the phenomenon that the puncture needle accidentally extends out to cause mistaken puncture in the puncture process is avoided. In addition, during puncture, the extending length of the puncture needle under an X-ray image is difficult to judge, so that the length control difficulty is high, and the risk of puncturing or damaging cardiac muscle or surrounding tissues and even causing pericardial tamponade is increased.
In addition, the existing intracardiac ultrasonic catheters are independent catheters, cannot be accessed with surgical instruments in a general way, and need to be accessed independently when in use. The space occupation phenomenon occurs during operation, so that the instrument providing the image interferes with the therapeutic instrument during operation of the instrument. The imaging area of an ultrasound catheter has certain limitations and cannot provide an image of a large area or a specific area during the operation.
Disclosure of Invention
The present invention is directed to an ultrasound guiding catheter and an ultrasound guided puncture system, which at least solve one of the problems of the prior art or the related art.
To achieve the above objects, in a first aspect, the present invention provides an ultrasonically guided puncture system comprising an adjustable curved sheath tubing assembly, a dilator assembly, a puncture needle assembly, an ultrasonic 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 a puncture needle of the puncture needle assembly can puncture through the second working channel;
the ultrasonic imaging assembly comprises a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the far end of the catheter body and have a contraction position and an opening position, and in the contraction position, the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier flares away from the catheter body;
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.
In a second aspect, the present invention provides an ultrasound guided catheter comprising a catheter body, an ultrasound imaging assembly and a control assembly;
the catheter body includes a working channel for passage of an instrument;
the ultrasonic imaging assembly comprises a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the far end of the catheter body and have a contraction position and an opening position, and in the contraction position, the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier flares away from the catheter body;
the control component 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.
Optionally, the carrier comprises at least a first end and a second end, the first end being connected to the catheter body and the second end being capable of being located in the open position away from the catheter body.
Optionally, the control assembly comprises an expansion mechanism connected to the second end, the expansion mechanism being capable of switching the carrier from the retracted position to the preset open position.
Optionally, 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, and the second end of the carrier can be rotated to the preset opening position relative to the catheter body by pushing the push wire.
Optionally, the carrier includes at least a first end and a second end, a folding area is disposed between the first end and the second end, the first end is connected to the catheter body, and the control component can move the carrier away from the catheter body in the folding area to the preset open position or move the carrier from the open position away from the catheter body in the folding area to the retracted position.
Optionally, the carrier is expandable to a maximum extent to the open position relative to the catheter body in the absence of an external force.
Optionally, the control assembly comprises a retraction mechanism capable of switching the carrier from the open position of maximum expansion to the retracted position.
Optionally, the retracting mechanism comprises a pulling wire connected to the second end, the second end being switchable from the open position to the retracted position by pulling the pulling wire; or
The retraction mechanism includes a sleeve structure movably disposed on the catheter body, the second end being switchable from the open position to the retracted position by actuating the sleeve structure to move relative to the catheter body.
Optionally, a groove for accommodating the carrier is further provided on the outer wall of the catheter body.
Optionally, a groove for accommodating the carrier is further disposed on the outer wall of the catheter body, a concave portion is disposed in the groove, the concave portion is used for accommodating the second end, and the push wire extends out of the groove from the surface of the concave portion and is connected with the second end.
Optionally, a groove for accommodating the carrier is further disposed on an outer wall of the catheter body, and a concave portion is disposed in the groove and used for accommodating the second end; the pull wire extends out of the groove through the surface of the concave part and is connected with the second end.
Optionally, the carrier comprises a pivot portion, the carrier is rotatable by the pivot portion to the preset open position, and the second end is integrally formed with the pivot portion.
Optionally, the carrier is integrally formed with the catheter body, and the cable for connecting the transducer unit has no exposed portion between the carrier and the catheter body.
Optionally, the carrier is S-shaped, and when the carrier is located at the open position, the portions of the carrier located at both sides of the folded region are dislocated along the axial direction of the catheter body, and the orientation of the transducer units on the portions is consistent.
Optionally, the carrier is horn structure and can set up with drawing in the pipe is originally internal, ultrasonic imaging subassembly still includes and is used for supporting the support piece of carrier, support piece is located this internal and can pass through of pipe is originally internal and can pass through the driving and moving of control assembly is relative pipe body removes so that the second end exposes it is the loudspeaker form expansion behind the pipe body.
Optionally, the carrier is a horn-shaped structure, and the ultrasound imaging assembly further includes a support member for supporting the carrier, the support member being capable of maximally expanding the carrier to the open position relative to the catheter body without external force; the carrier is collapsibly disposed within the sleeve structure as the sleeve structure is moved distally of the catheter body.
Optionally, the carriers are symmetrically distributed about the centre of the catheter body.
Optionally, at least one transducer of the transducer unit is independently controllable.
Based on this, the invention also provides an ultrasonic guided puncture system, which comprises the ultrasonic guided catheter.
Optionally, the puncture system further comprises an adjustable bent sheath tube 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 dilator body comprises a second working channel, and a puncture needle of the puncture needle assembly can puncture through the second working channel; the dilator body is connected with a second control mechanism of the dilator assembly;
the catheter body is the sheath body or the dilator body.
Optionally, the puncture system further comprises a length adjuster, the puncture needle assembly comprises a third control mechanism, the length adjuster is arranged between the third control mechanism and the second control mechanism of the dilator assembly, and the length of the puncture needle extending out of the dilator body is adjusted by adjusting the distance between the second control mechanism and the third control mechanism through adjusting the length adjuster.
Optionally, the length adjuster is in threaded connection with one of the second operating mechanism and the third operating mechanism, and the length of the puncture needle extending out of the dilator body is adjusted by rotating the length adjuster.
Optionally, a mark is arranged at a thread of the length adjuster, a scale is correspondingly arranged on the housing 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 a scale value aligned with the mark.
Optionally, the third control mechanism further comprises an operating part and a guide groove, and the operating part is located in the guide groove and can move in the guide groove to drive the puncture needle to extend and retract.
Optionally, the puncture needle assembly comprises a third control mechanism, the third control mechanism further comprises 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.
Optionally, the third operating mechanism further comprises an operating member and a guide groove, and 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.
Optionally, the third control mechanism further includes a limiting structure, the limiting structure includes a limiting member disposed on the operating member and a stop member engaged with the limiting member, and the limiting member is engaged with the stop member to lock the puncture needle at a locking position.
Optionally, the position limiting structure further includes a first elastic member, and the first elastic member is capable of applying a force to the operating member to keep the position limiting member and the stop member abutting against each other in the locking position.
Optionally, at least one of the limiting member and the stop member includes a guiding inclined surface, and the limiting member and the stop member can be set in the locking position by the guiding of the guiding inclined surface in the process of setting the puncture needle in the locking position, so as to lock the puncture needle.
Optionally, the operating member comprises a channel for passing the stop member, and when tissue puncture is required, the stop member can pass through the channel, so that the distal end of the puncture needle extends out of the dilator body.
Optionally, the energy storage assembly of the third operating mechanism includes a second elastic member, the stopper is disposed on the puncture needle, one end of the second elastic member abuts against the stopper, and the other end of the second elastic member abuts against the third operating mechanism; when the puncture needle is in the locking position, the limiting part is matched with the stop part, so that the second elastic part is in a compressed state, and the motion of the puncture needle is limited.
Optionally, a liquid injection joint is arranged at the proximal end of the puncture needle, and the stop piece and the limiting piece can be arranged at the locking position by pulling the liquid injection joint.
The invention provides a puncture needle assembly, which comprises a puncture needle and an operating mechanism, wherein the puncture needle is arranged on the operating mechanism, the puncture needle has a locking state and a releasing state, the operating mechanism comprises an energy storage assembly, an operating piece and a limiting structure, and the energy storage assembly can act on the puncture needle to enable the far end of the puncture needle to puncture tissues; the limiting structure can keep the puncture needle in the locking state, and in the locking state, the puncture movement of the puncture needle to the tissue is limited; the operating piece can enable the puncture needle to be switched from the locking state to the releasing state; in the release state, the puncture needle can puncture tissues under the action of the energy storage assembly.
Optionally, the puncture needle assembly further comprises a length adjuster, and the puncture depth of the puncture needle can be adjusted by adjusting the length adjuster.
Optionally, the length adjuster is in threaded connection with the control mechanism, and the puncture depth of the puncture needle is adjusted by rotating the length adjuster.
In a fourth aspect, the present invention provides an introducer needle assembly comprising the above described introducer needle assembly.
Optionally, the puncture system further comprises an adjustable bent sheath tube assembly, a dilator assembly and an ultrasonic imaging 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 can puncture through the second working channel; the ultrasonic imaging assembly is arranged on the sheath tube body or the dilator body.
In a fifth aspect, the invention provides a puncture system, which is characterized by comprising an adjustable bent sheath tube 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 dilator body comprises a second working channel, and a puncture needle of the puncture needle assembly can puncture through the second working channel; the dilator body is connected with a second control mechanism of the dilator assembly; the puncture needle assembly comprises a puncture needle and a third control mechanism, the puncture needle is arranged on the third control mechanism, the puncture system further comprises a length regulator, the length regulator is arranged between the third control mechanism and a second control mechanism of the dilator assembly, and the distance between the second control mechanism and the third control mechanism is adjusted through adjusting the length regulator, so that the length of the puncture needle extending out of the dilator body is adjusted.
The invention provides an ultrasonic guide catheter and an ultrasonic guide puncture system, which at least have one of the following beneficial effects:
1) By integrating the ultrasonic imaging assembly on the catheter body, visual images can be displayed on the anatomical form of the interatrial septum, and a visual tissue structure in an instrument range is provided, so that a proper puncture point on the interatrial septum can be better positioned, an operator is guided to operate, the risk of performing an operation is reduced, and the smooth operation is facilitated;
2) By integrating the ultrasonic imaging component on the catheter body, the problems that the existing instrument is difficult to position and the ultrasonic catheter occupies space when a human body intervention operation is carried out are solved;
3) By additionally arranging the length regulator between the second control mechanism of the dilator assembly and the third control mechanism of the puncture needle assembly, the problem that the length of the traditional puncture needle extending under an X-ray image is difficult to judge, so that the difficulty of length control is high, and the risk of puncturing or damaging cardiac muscle or surrounding tissues or even causing pericardial tamponade is increased.
Drawings
Those skilled in the art will appreciate that the drawings are provided for a better understanding of the invention and do not set forth any limitations on the scope of the invention. Wherein:
FIG. 1 is a basic block diagram of an ultrasound guide catheter provided in accordance with an embodiment of the present invention;
FIG. 2 is a schematic view of a closed carrier according to one embodiment of the present invention;
FIG. 3 is a schematic view of a carrier according to an embodiment of the present invention when deployed;
FIG. 4 is a partially enlarged view of a carrier according to one embodiment of the present invention when deployed;
FIG. 5 is a schematic view of a hinge assembly according to one embodiment of the present invention;
FIG. 6 is a schematic view of a push carrier with grooves according to one embodiment of the present invention;
fig. 7 is a schematic view of a push carrier with a concave portion according to a second embodiment of the present invention;
fig. 8 is a schematic view of a foldable carrier with a push wire according to a second embodiment of the present invention;
fig. 9 is a schematic view of a collapsible carrier with a sleeve according to a fourth embodiment of the present invention;
fig. 10 is a schematic view of a pop-up carrier with a pull line according to a third embodiment of the present invention;
fig. 11 is a schematic diagram of a pop-up carrier with a concave part in a front pull type according to a third embodiment of the present invention;
fig. 12 is a schematic diagram of a pop-up carrier with a recess back-pull type according to a third embodiment of the present invention;
fig. 13 is a schematic diagram of a pop-up carrier with a tilt groove according to a third embodiment of the present invention;
fig. 14 is a schematic view of a pop-up carrier with a cartridge according to a fourth embodiment of the present invention;
fig. 15 is a schematic view of a pop-up carrier closed receiving provided by the fourth embodiment of the present invention;
fig. 16 is a schematic view of open storage of a pop-up carrier according to the fourth embodiment of the present invention;
fig. 17 is a schematic view of an S-shaped carrier with a sleeve according to a fifth embodiment of the present invention;
FIG. 18 is a schematic view of an S-type vector provided in example five of the present invention;
FIG. 19 is a schematic view of a trumpet carrier according to a sixth embodiment of the present invention;
fig. 20 is a schematic view of a trumpet carrier receiving sleeve provided in accordance with a sixth embodiment of the present invention;
fig. 21 is a top plan view of a trumpet shaped sheet carrier according to a sixth embodiment of the present invention as it is unfolded;
fig. 22 is a top view of a trumpet-shaped sheet carrier according to a sixth embodiment of the present invention when it is gathered;
FIG. 23 is a schematic illustration of an asymmetric distribution of linear carriers provided by an embodiment of the present invention;
FIG. 24 is a schematic view of a centrosymmetric distribution of linear carriers provided in an embodiment of the present invention;
FIG. 25 is a schematic view of a centrosymmetric S-shaped carrier according to an embodiment of the present invention;
FIG. 26 is a schematic diagram of a transducer arrangement provided by an embodiment of the present invention;
FIG. 27 is a schematic view of an introducer needle assembly provided in accordance with an embodiment of the present invention;
FIG. 28 is a schematic diagram of a scale on the third operating mechanism according to the embodiment of the present invention;
FIG. 29 is a schematic view of a push button spike assembly in a locked position in accordance with one embodiment of the present invention;
FIG. 30 is a schematic view of a push button spike assembly of the present invention shown unlocked;
FIG. 31 is a schematic view of another push button lancing assembly according to one embodiment of the present invention in a locked position;
FIG. 32 is a schematic view of another push button spike assembly in accordance with an embodiment of the present invention shown unlocked;
fig. 33 is a schematic view of the pop-up puncture assembly according to the second embodiment of the present invention when it is charged.
Fig. 34 is a schematic view of the pop-up lancing assembly according to the second embodiment of the present invention after ejection.
In the drawings:
1-sheath body; 2-a carrier; 3-a transducer unit; 4-pushing the wire; 5-a hinge member; 6-a cable; 7-a groove; 8-a stay wire; 9-a recess; 10-a sleeve structure; 11-a support;
1-1-a working channel; 2-1-a first end of a carrier; 2-2-a second end of the carrier;
100-length adjuster; 101-a third steering mechanism; 102-puncture needle; 103-label; 104-an operating member; 105-a limiter; 106-a stop; 107-a first elastic member; 108-a second elastic member; 109-liquid injection joint; 110-guide ramp.
Detailed Description
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.
As used herein, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise. As used herein, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "plurality" as used herein is generally employed in the sense including "at least one" unless the content clearly dictates otherwise. The term "at least two" as used herein is generally employed in a sense including "two or more" unless the content clearly dictates otherwise. Furthermore, the terms "first", "second", "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", "third" may explicitly or implicitly include one or at least two of the features.
The core idea of the invention is to provide an ultrasonic guide catheter and an ultrasonic guide puncture system, so as to solve the problems that the existing instruments are difficult to position and the ultrasonic guide catheter occupies space when a human body interventional operation is carried out.
The ultrasound guided puncture system comprises an adjustable bent sheath tube 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 a puncture needle of the puncture needle assembly can puncture through the second working channel;
the ultrasonic imaging assembly comprises a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the far end of the catheter body and have a contraction position and an opening position, and in the contraction position, the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier flares away from the catheter body;
the catheter body is the sheath body or the dilator body and the like;
the control component 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 assembly and a control assembly;
the catheter body includes a working channel for passage of an instrument;
the ultrasonic imaging assembly comprises a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the far end of the catheter body and have a contraction position and an opening position, and in the contraction position, the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier flares away from the catheter body;
the control component 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.
So dispose, through with ultrasonic imaging subassembly integrated extremely on the pipe body, can provide the visual organizational structure of apparatus within range when carrying out the human intervention operation to the operating point of apparatus is fixed a position better, guides the operation of operator, reduces the risk of executing the art, and the operation of being convenient for goes on smoothly. Moreover, because the ultrasonic imaging component is integrated on the catheter body, when the interatrial puncture operation is required, instruments such as an interatrial puncture system, a puncture needle, a guide wire, a sheath system and the like do not need to be exchanged for many times, the operation steps are greatly simplified, and the risk of unnecessary adverse events at the puncture part is reduced.
Example one
Referring to fig. 1-3, the ultrasound guiding catheter includes a catheter body 1, an ultrasound imaging assembly and a control assembly;
the catheter body 1 comprises a working channel 1-1 for instruments to pass through;
the ultrasonic imaging assembly comprises a plurality of carriers 2 and transducer units 3 arranged on the carriers 2, wherein the carriers 2 are arranged at the far end of the catheter body 1 and have a contraction position and an opening position, and in the contraction position, the catheter body 1 can safely pass through a tissue cavity, as shown in fig. 2; in the open position, at least a portion of the carrier 2 flares away from the catheter body 1, as shown in fig. 3;
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.
The definitions of "proximal" and "distal" herein are: "proximal" generally refers to the end of the medical device that is near the operator during normal operation, while "distal" generally refers to the end of the medical device that first enters the patient during normal operation. It should be understood that the working channel 1-1 may preferably not only be limited to guiding a guide wire therethrough, but may also allow passage of instruments other than a guide wire.
Specifically, the ultrasonic imaging component is used for transmitting and receiving ultrasonic signals, analyzing and outputting images. The ultrasound imaging assembly in this embodiment can be placed in different treatment purpose host devices and is compatible with the host devices.
The ultrasonic imaging assembly comprises a plurality of carriers 2 and transducer units 3 positioned on the carriers 2, the carriers 2 are used as mounting platforms of the transducer units 3 and can be mounted at the distal ends of corresponding catheter bodies 1, and the carriers 2 enter a cavity together with the catheter bodies 1 to perform surgery in the process of surgery. The transducer unit 3 is arranged on a carrier 2 at the far end of the sheath, a cable is connected with the transducer unit 3 on the carrier 2 at the far end of the catheter body 1, the near end of the catheter body 1 is connected with a wiring in the control assembly, and then the cable is connected with a host of an ultrasonic system through the wiring of the control assembly.
Further, the carrier 2 comprises at least a first end 2-1 and a second end 2-2, the first end 2-1 being connected to the catheter body 1, the second end being capable of being located in the open position away from the catheter body 1.
Furthermore, the control assembly comprises an expansion mechanism connected to the second end, the expansion mechanism being capable of switching the carrier 2 from the retracted position to the preset open position.
Specifically, referring to fig. 2 to 5, the first end 2-1 of the carrier 2 is hinged to the catheter body 1, the expansion mechanism includes a push wire 4, in the retracted 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 to the preset open position relative to the catheter body 1 by pushing the push wire 4. The open position may be opened at different angles relative to the axis of the catheter body 1 depending on the requirements 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 realized by pushing the push wire 4. When the ultrasonic guide catheter needs to be withdrawn from the tissue cavity, the push wire 4 can pull the second end of the carrier 2 to make the carrier 2 abut on the catheter body 1.
Preferably, the first end 2-1 of the carrier 2 is pivotally mounted on the catheter body 1 through a hinge 5, and a portion of the hinge 5 exposed out of the catheter body 1 can be hinged with the first end 2-1 of the carrier 2, so that the carrier 2 can rotate around the hinge 5.
Preferably, the carrier 2 comprises a pivot by which the second end can be rotated away from the catheter body 1 to the preset open position, the second end being integrally formed with the pivot.
It is further preferred that the distal and proximal end surfaces of the carrier 2 are curved to reduce resistance and tissue damage as the ultrasound guide catheter is advanced through the lumen. Preferably, the first end 2-1 of the carrier 2 is a distal end and the second end 2-2 of the carrier 2 is a proximal end.
In this embodiment, at least a part of the cable 6 of the ultrasound imaging module is embedded in the carrier 2 and electrically connected to the transducer unit 3, and at least a part of the cable 6 led out from the carrier 2 is embedded in the catheter body 1, and the proximal end thereof is electrically connected to a connector. Preferably, the connector is located on the control assembly (e.g., catheter control handle) by which it can be connected to an ultrasound host module.
Preferably, 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, and during the rotation of the carrier 2 around the hinge 5, the portion of the flexible cable 6 can be turned over a certain angle to ensure the connection of the transducer unit 3 and the host, as shown in fig. 3 and 4.
In this embodiment, the carrier 2 may be mounted in different forms, and may be a single carrier 2 or a combination of multiple carriers 2. During the use, the carrier 2 of upset can provide the image under a plurality of different angles, and a plurality of different carriers 2 can be controlled by corresponding line 4 that pushes away in the operating handle, produce the detailed image effect under the different position.
Preferably, referring to fig. 6, a groove 7 for accommodating the carrier 2 is further disposed on an outer wall of the catheter body 1. When the ultrasonic imaging component is not needed to be used, the ultrasonic imaging component can be accommodated in the groove 7, so that the carrier 2 and the hinge part 5 of the ultrasonic imaging component do not protrude out of the surface of the catheter body 1, the bulge of the catheter body 1 is reduced, and the passing performance of the ultrasonic guide catheter is better.
Further preferably, referring to fig. 7, a groove 7 for accommodating the carrier is further disposed on an outer wall of the catheter body, a concave portion 9 is disposed in the groove 7, the concave portion 9 is used for accommodating the second end, and the push wire 4 extends out of the groove 7 from a surface of the concave portion 9 and is connected with the second end, so as to achieve a better accommodating effect.
Example two
Referring to fig. 8, different from the first embodiment, in the present embodiment, the carrier 2 at least includes a first end 2-1 and a second end 2-2, a folding area is disposed 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 away from the catheter body 1 in the folding area to the preset open position or move the carrier 2 from the open position away from the catheter body 1 in the folding area to the retracted position.
In this embodiment, the control component may be a push wire 4 or a sleeve structure 10, please refer to fig. 9, 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 is movably disposed on the catheter body 1, and the carrier 2 can be moved away from the catheter body 1 to the preset open position in the folding region or the carrier 2 can be moved from the open position away from the catheter body 1 to the retracted position in the folding region by driving the sleeve structure 10 to move relative to the catheter body 1.
Preferably, the first end 2-1 of the carrier 2 is a distal end and the second end 2-2 of the carrier 2 is a proximal end.
EXAMPLE III
Referring to fig. 10, unlike the previous embodiment, in this embodiment, the carrier 2 can be expanded to the open position to the maximum extent relative to the catheter body 1 without external force.
In particular, the control assembly comprises a retraction mechanism capable of switching the carrier 2 from the open position of maximum expansion to the retracted position.
In this embodiment, the retracting mechanism comprises a pulling wire 8, the pulling wire 8 is connected to the second end 2-2, and the second end 2-2 can be switched from the open position to the retracted position by pulling the pulling wire 8.
Preferably, referring to fig. 11-12, the outer wall of the catheter body 1 is further provided with a groove 7 for accommodating the carrier, the groove is provided with a recess 9, the recess 9 is used for accommodating 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 with the second end 2-2. When the pull wire 8 no longer extends out of the side of the groove 7 on the catheter body 1, but extends out of the bottom of the groove 7, a deeper area (i.e. a concave part 9) is arranged in the whole groove 7, and the area is positioned at the extending part of the pull wire 8, so that the carriers are better folded, and two ways for accommodating the carriers 2 are derived. Referring to fig. 11, the pulling wire 8 is connected to the proximal end of the carrier 2, and the proximal end of the carrier 2 is moved closer to the surface of the catheter body 1 by pulling the pulling wire 8; alternatively, referring to fig. 12, the pulling wire 8 is connected to the distal end of the carrier 2, and the distal end of the carrier 2 is moved closer to the surface of the catheter body 1 by pulling the pulling wire 8.
Or, referring to fig. 13, 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, so that the carrier can obtain a better furling effect.
Example four
Referring to fig. 14, unlike the previous embodiment, in the present embodiment, the retracting mechanism includes a sleeve structure 10, the sleeve structure 10 is movably disposed on the catheter body 1, and the second end 2-2 can be switched from the open position to the retracted position by driving the sleeve structure 10 to move relative to the catheter body 1.
Preferably, a plurality of accommodating grooves for accommodating the carrier 2 are formed in 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 is just clamped into the sleeve structure 10 or the accommodating grooves of the catheter body 1.
Based on the third and fourth embodiments, two ways of receiving the carrier 2 (the carrier may be made of elastic material, such as spring, nitinol, or polymer) are derived. The carrier 2 comprises a pivot arranged between said first end 2-1 and said second end 2-2, see fig. 15, by which said second end 2-2 of said carrier 2 is turned towards said first end 2-1 close to said carrier 2 and the opening angle of the carrier 2 with respect to the catheter body 1 is changed; alternatively, referring to fig. 16, by the pivot, the second end 2-2 of the carrier 2 rotates towards 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, and the two ways of receiving the carrier 2 are both suitable for the pull wire 8 or the sleeve structure 10.
Similarly, the outer wall of the catheter body 1 may also be provided with a groove for accommodating the carrier 2.
EXAMPLE five
Referring to fig. 17-18, unlike the previous embodiment, in the present embodiment, the carrier 2 is S-shaped, and when the carrier 2 is located at the open position, the portions of the carrier 2 located at both sides of the folded region are dislocated along the axial direction of the catheter body 1, and the orientations of the transducer units 3 on the portions are the same. The S-shaped carrier is adopted to replace a linear carrier, so that more transducers can be used for obtaining an enhanced ultrasonic effect. Respectively at the S type carrier the inboard and the outside installation of the part of folding district both sides transducer unit 3 is pushed to folding back at S type carrier, the transducer unit 3 of the inside and outside both sides of S type carrier can have unanimous orientation after folding, and inside and outside both sides can all be installed transducer unit 3 to carry out the transmission of ultrasonic wave to same direction simultaneously, thereby obtain higher ultrasonic emission density and imaging effect.
EXAMPLE six
Referring to fig. 19, unlike the above-mentioned embodiment, in this embodiment, the carrier 2 is a horn-shaped structure movably disposed at the distal end of the catheter and is retractably disposed in the catheter body 1, the ultrasound imaging assembly further includes a supporting member 11 for supporting the carrier 2, the supporting member 11 is disposed in the catheter body 1 and can be driven by the control assembly to move relative to the catheter body 1 so as to enable the second end to be withdrawn and deployed after being exposed out of the catheter body 1, or can be driven by the control assembly to move relative to the catheter body 1 so as to enable the second end to be retractably disposed in the catheter body 1.
Alternatively, the carrier 2 is a horn-shaped structure disposed at the distal end of the catheter and can be furledly disposed in the sleeve structure 10, referring to fig. 19-21, the carrier 2 is a horn-shaped structure, the ultrasound imaging assembly further includes supporting members 11 for supporting, the supporting members 11 are connected by a flexible material to form sectors, furledly folding lines are disposed on the flexible material according to the sectors, and the circuit and the transducer are disposed. The supporting parts 11 can lead the carrier 2 to guide the flexible material between the supporting parts 11 to be expanded to the opening position to the maximum extent under the condition of not receiving external force relative to the catheter body 1; when the sleeve structure 10 moves towards the distal end of the catheter body 1, the flexible material folds and folds according to the arranged folding marks, so that the carrier 2 can be arranged in the sleeve structure 10 in a folding manner. The transducers arranged on the flexible material can form a single transducer array, the ultrasonic transducers in all sector areas can form a larger transducer array, the ultrasonic phased array technology is used for exciting and receiving ultrasonic waves in different directions, real-time imaging is realized through an image algorithm, the imaging area is related to the unfolding geometric shape of the veneering, and the tissue structure in front of the far end of the catheter body 1 can be seen.
In the embodiment, the supporting members 11 are made of high-elasticity wires, such as spring steel, nitinol, titanium alloy, etc., and the supporting members 11 include a plurality of wires and are fixed by a ring-shaped fixing member to enhance the connection strength between the supporting members 11.
In a preferred embodiment, referring to fig. 21-22, the wires in the horn-shaped structure carrier 2 can be replaced by pre-shaped high-elastic sheets (such as spring steel, nitinol, titanium alloy, etc.), fixing rings are placed to enhance the connection strength between the sheets and the catheter body 1, the flexible material originally folded on the wires according to sectors is eliminated, and the flexible circuit and the transducer are directly arranged on the high-elastic sheets, which can be applied to instruments with certain requirements on space structure. When the sleeve structure 10 moves towards the distal end of the catheter body 1, the high elastic wire is folded by the sleeve structure 10, so that the carrier 2 can be arranged in the sleeve structure 10 in a folded manner. By adjusting the relative position of the sleeve structure 10 and the carrier 2, the degree of carrier openness can be controlled.
In all the embodiments described, the carrier 2 may be single or multiple. The distribution of the carriers 2 may be offset to one side of the catheter body 1, as shown in fig. 23, or may be symmetrically distributed around the center of the catheter body 1, as shown in fig. 24-25, which is not limited by the present application, and the number of the carriers 2 is not more than 8 considering the actual accommodation capacity and the overlapping condition of the ultrasound coverage.
In the described embodiments, one transducer unit 3 may comprise a single transducer or an array of multiple transducers, as shown in fig. 26. The transducers may be mounted on the outside or inside of the carrier 2 with the spacing d between the transducers on a single carrier 2 being between 0.2 λ and 1.2 λ (λ being the wavelength of the ultrasonic waves emitted by the transducers). When the transducers form an array, the array may be formed by a plurality of transducers on a single carrier 2, or may be formed by a plurality of different transducers on the carrier 2. Multiple transducers may be grouped, multiple transducers in a single group may transmit and receive simultaneously, the transducers in a group may have the effect of a single transducer, and in particular, when all transducers are transmitting and receiving simultaneously, the entire array of transducers may have the effect of a single transducer. The host of the ultrasonic system controls the transducer through the cable 6 to form the effect of transmitting ultrasonic waves in a specific sequence of the transducer array to reach the phased array, and the ultrasonic imaging effect of a specific area is enhanced.
In another aspect, the present invention provides an ultrasonically guided puncture system comprising an ultrasonically guided catheter as described above.
Further, the puncture system also comprises an adjustable bent sheath tube 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 dilator body comprises a second working channel, and a puncture needle of the puncture needle assembly can puncture through the second working channel; the dilator body is connected with a second control mechanism of the dilator assembly;
the catheter body is the sheath body or the dilator body.
In this embodiment, the dilator body has a hollow tubular structure, and a second working channel for the puncture needle to enter and exit is formed inside the dilator body. Preferably, the distal end of the dilator body is tapered to facilitate passage through the atrial septum.
Referring to fig. 27, the puncture system further includes a length adjuster 100, the puncture needle assembly includes a third manipulating mechanism 101, the length adjuster 100 is disposed between the third manipulating mechanism 101 and a second manipulating mechanism (not shown in the figure) of the dilator assembly, and the length of the puncture needle 102 extending out of the dilator body is adjusted by adjusting the length adjuster 100 to adjust the distance between the second manipulating mechanism and the third manipulating mechanism 101. The distance between the third control mechanism 101 and the second control mechanism can be adjusted by adjusting the relative position between the length adjuster 100 and the third control mechanism 101, so as to adjust the length of the puncture needle 102 extending out of the dilator body; or, the distance between the third manipulating mechanism 101 and the second manipulating mechanism can be adjusted by adjusting the relative position between the length adjuster 100 and the second manipulating mechanism, so as to adjust the length of the puncture needle 102 extending out of the dilator body.
By arranging the length regulator 100, the problem that the extended length of the traditional puncture needle 102 under an X-ray image is difficult to judge, so that the length control difficulty is high, and the risk of puncturing or damaging cardiac muscle or surrounding tissues and even causing pericardial tamponade is increased is solved.
The relative movement between the length adjuster 100 and the second or third operating mechanism 101 includes, but is not limited to, tight fit movement, bayonet insertion and extraction, thread rotation, etc.
Further, the length adjuster 100 is in threaded connection with one of the second manipulating mechanism and the third manipulating mechanism 101, and the length of the puncture needle 102 extending out of the dilator body is adjusted by rotating the length adjuster 100. In this embodiment, the length adjuster 100 is screwed to the third operating mechanism 101.
Preferably, referring to fig. 28, a mark 103 is disposed at a thread of the length adjuster 100, a scale is correspondingly disposed on the housing of the one of the second manipulating mechanism and the third manipulating mechanism 101, and the maximum length of the puncture needle 102 extending out of the dilator body is obtained by observing a scale value aligned with the mark 103. By observing the scale value of the alignment of the mark 103 on the length adjuster 100 when the length adjuster 100 is rotated, the specific length of the puncture needle 102 projection can be determined without conducting the puncture needle 102 projection inspection. For example, when the indicia is aligned with the zero point scale, indicating that the needle 102 has been extended to a maximum travel, the distal end of the needle 102 is aligned with the distal end of the dilator body. For example, when the indicia is aligned with the scale "3", indicating that the needle 102 is extended to the maximum travel, the needle 102 is 3 units beyond the distal end of the dilator body.
Alternatively, the length adjuster 100 may be a retractable mechanism connected between the second operating mechanism and the third operating mechanism 101, and the retractable mechanism is in the common knowledge and is not described herein.
Optionally, the third operating mechanism 101 further includes an operating member 104 and a guide slot, and the operating member 104 is located in the guide slot and can move in the guide slot to drive the puncture needle 102 to extend and retract.
Optionally, the third operating mechanism 101 further includes an operating element and a guide groove, and the operating element is located in the guide groove and can move in the guide groove to lock or unlock the movement of the puncture needle.
Example one
Referring to fig. 29 to 32, the operating member 104 is a push button movably disposed on the third manipulating mechanism 101, the push button is movably connected to the puncture needle 102 up and down, and the puncture needle 102 can be kept coaxial with the dilator body during pressing the push button. The third control mechanism 101 further comprises a limiting structure, the limiting structure comprises a limiting member 105 disposed on the operating member 104 and a stopping member 106 engaged with the limiting member 105, and the limiting member 105 and the stopping member 106 are engaged to lock the puncture needle 102 at a locking position.
The stopper 105 can be disengaged from the stopper 106 by pressing the push button to unlock the puncture needle 102, and then the push button is pushed continuously to move the puncture needle 102 in the pushing direction, i.e. to control the extension or retraction of the puncture needle 102.
Preferably, the amount of movement of the operating element 104 in the pushing direction of the puncture needle 102 can be adjusted by adjusting the length of the guide groove, and thus the pushing amount of the puncture needle 102 can be adjusted.
As a first preferred example in the present embodiment, referring to fig. 29 to 30, the limiting member 105 and the stopping member 106 are disposed on the push button and the third operating mechanism, respectively. In the locked position, the stopper 106 is located at a position close to the distal end of the puncture needle 102 with respect to the stopper 105, and the stopper 105 abuts against the stopper 106 to restrict the movement of the puncture needle 102; when the push button is pressed down, the stop part 106 is staggered in the vertical direction of the stop part 105, namely, the stop part 106 is no longer located on the stroke of the stop part 105, which is equivalent to unlocking the puncture needle 102, the downward pressure on the push button can be released at the moment, and the push button can be driven to move along the pushing direction of the puncture needle 102 to drive the puncture needle 102 to move along the pushing direction.
As a second preferred example in the present embodiment, referring to fig. 31-32, the limiting member 105 and the stopping member 106 are disposed on the push button and the third operating mechanism, respectively. Under the locking position, the stop member 106 is close to the distal end of the puncture needle 102 relative to the stop member 105, and the distal end of the stop member 105 and the stop member 106 are mutually buckled, so that the puncture needle 102 is limited to move; when the push button is pressed down, the limiting member 105 and the stop member 106 are separated from each other, that is, the stop member 106 is no longer located on the stroke of the limiting member 105, which is equivalent to unlocking the puncture needle 102, and at this time, the downward pressure on the push button can be released, and the push button is driven to move along the pushing direction of the puncture needle 102, so that the puncture needle 102 can be driven to move along the pushing direction.
Preferably, the position limiting structure further includes a first elastic member 107, and the first elastic member 107 can apply a force to the operating member 104 to keep the position limiting member 105 and the stop member 106 in contact with each other in the locking position. In this embodiment, the first elastic member 107 is located at the bottom of the push button and applies a vertical upward force to the push button, so as to ensure that the limiting member 105 can be blocked by the stop member 106 under the condition that the push button is accidentally stressed, so as to prevent the puncture needle 102 from being accidentally extended. The first elastic element 107 is, for example, a spring sheet, etc., which is not limited in this application.
Preferably, at least one of the limiting element 105 and the stopping element 106 includes a guiding inclined plane 110, and the limiting element 105 and the stopping element 106 can be arranged at the locking position by the guiding of the guiding inclined plane 110 during the process of arranging the puncture needle 102 at the locking position, so as to lock the puncture needle 102.
Preferably, a liquid injection joint 109 is provided at the proximal end of the puncture needle 102, and the stopper 106 and the stopper 105 can be set at the locking position by pulling the liquid injection joint 109.
Example two
The difference between the first embodiment and the second embodiment is that, referring to fig. 33 and 34, in the present embodiment, the stop member 106 is disposed on the puncture needle 102, the operating member 104 can move vertically in the guide groove, for example, by pressing, and the operating member 104 includes a channel for the stop member 106 to pass through, and the stop member 105 can be understood as a lower region of the channel. In the locked position, the stopper 106 is close to the proximal end of the puncture needle 102 with respect to the operation element 104, and the stopper 106 and the stopper 105 abut against each other to restrict the movement of the puncture needle 102; when the operating element 104 is pressed down, the limiting element 105 is vertically staggered with respect to the stop element 106, that is, the limiting element 105 is no longer located on the stroke of the stop element 106, so that the stop element 106 can pass through the channel, and the distal end of the puncture needle 102 can extend out of the dilator body.
Preferably, the puncture needle 102 assembly includes a third operating mechanism 101, and the third operating mechanism 101 further includes an energy storage assembly capable of acting on the puncture needle 102 to push the distal end of the puncture needle 102 out of the dilator body. By arranging 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 when the puncture needle 102 punctures, so that the atrial septum does not need to be manually pushed out of a tent, and the puncture risk is reduced.
Further preferably, the energy storage component of the third operating mechanism 101 comprises a second elastic element 108, as shown in fig. 33-34, the stopper 106 is disposed on the puncture needle 102, one end of the second elastic element 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 locking position, the stopper 105 cooperates with the stopper 106 to compress the second elastic element 108, so as to limit the movement of the puncture needle 102. The second elastic member 108 is used for energy storage to push the puncture needle 102, and its structure includes but is not limited to a spring, a cylinder, a balloon, etc. Taking a spring as an example, as shown in fig. 33, before use, the puncture needle 102 is pulled back, the spring is compressed, the stopper 106 is blocked by the limiting element 105 on the operating element 104, the puncture needle 102 is in a locked state, and energy storage is completed. In use, as shown in fig. 34, the operating member 104 is depressed, the stop member 105 vertically displaces the stop member 106, the puncture needle 102 is released, and the spring extends the dilator acting against the atrial septum at a higher speed to puncture the atrial septum, and the puncture is completed.
Preferably, the position limiting structure further includes a first elastic member 107, and the first elastic member 107 can apply a force to the operating member 104 to keep the position limiting member 105 and the stop member 106 in contact with each other in the locking position. In this embodiment, the first elastic member 107 is located at the bottom of the push button and applies a vertical upward force to the push button, so as to ensure that the stop member 106-can be stopped by the stop member 105 under the action of the first elastic member 107, so as to prevent the puncture needle 102 from being accidentally extended. The first elastic element 107 is, for example, a spring plate, etc., which is not limited in this application.
Preferably, at least one of the limiting element 105 and the stopping element 106 includes a guiding inclined plane 110, and the limiting element 105 and the stopping element 106 can be arranged at the locking position by the guiding of the guiding inclined plane 110 during the process of arranging the puncture needle 102 at the locking position, so as to lock the puncture needle 102.
Preferably, a liquid injection connector 109 is provided at the proximal end of the puncture needle 102, and the stopper 106 and the stopper 105 can be set at the locking position by pulling the liquid injection connector 109.
In conclusion, the ultrasonic guide catheter provided by the invention has the advantages that the ultrasonic imaging component is integrated on the catheter body, so that the visual tissue structure in the instrument range can be provided, the puncture point can be better positioned, the operation of an operator is guided, the operation risk is reduced, and the smooth operation is facilitated. Based on the above, the invention also provides an ultrasonic guided puncture system, and the length regulator is additionally arranged between the second control mechanism of the dilator assembly and the third control mechanism of the puncture needle assembly, so that the problems that the length of the traditional puncture needle extending under an X-ray image is difficult to judge, the length control difficulty is high, and the risk of puncturing or damaging cardiac muscle or surrounding tissues and even causing pericardial stuffing is increased are solved.
The above description is only a preferred embodiment of the present invention, and does not limit the present invention in any way. Any person skilled in the art can make any equivalent substitutions or modifications on the technical solutions and technical contents disclosed in the present invention without departing from the scope of the technical solutions of the present invention, and still fall within the protection scope of the present invention without departing from the technical solutions of the present invention.

Claims (33)

1. An ultrasonic guided puncture system, which is characterized by comprising an adjustable bent sheath tube component, a dilator component, a puncture needle component, an ultrasonic imaging component and a control component;
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 a puncture needle of the puncture needle assembly can puncture through the second working channel;
the ultrasonic imaging assembly comprises a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the far end of the catheter body and have a contraction position and an opening position, and in the contraction position, the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier flares away from the catheter body;
the catheter body is the sheath body or the dilator body;
the control component 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.
2. An ultrasonic guide catheter is characterized by comprising a catheter body, an ultrasonic imaging assembly and a control assembly;
the catheter body includes a working channel for passage of an instrument;
the ultrasonic imaging assembly comprises a plurality of carriers and transducer units arranged on the carriers, wherein the carriers are arranged at the far end of the catheter body and have a contraction position and an opening position, and in the contraction position, the catheter body can safely pass through a tissue cavity; in the open position, at least a portion of the carrier flares away from the catheter body;
the control component 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.
3. The ultrasound-guided catheter of claim 2, wherein the carrier comprises at least a first end and a second end, the first end being coupled to the catheter body, the second end being positionable in the open position away from the catheter body.
4. The ultrasound-guided catheter of claim 3, wherein the control assembly comprises an expansion mechanism coupled to the second end, the expansion mechanism being capable of shifting the carrier from the retracted position to the preset open position.
5. The ultrasound guide catheter of claim 4, wherein the first end of the carrier is hingedly connected to the catheter body, the expansion mechanism includes a push wire, the carrier is attached to an outer wall of the catheter body, and the second end of the carrier is rotatable relative to the catheter body to a predetermined open position by pushing the push wire.
6. The ultrasound guide catheter of claim 2, wherein the carrier includes at least a first end and a second end, a fold region disposed between the first end and the second end, the first end coupled to the catheter body, the control assembly configured to move the carrier away from the catheter body at the fold region to a preset open position or move the carrier from the open position away from the catheter body at the fold region to the collapsed position.
7. The ultrasound-guided catheter of claim 3, wherein the carrier is expandable to a maximum extent to the open position relative to the catheter body in the absence of an external force.
8. The ultrasound guided catheter of claim 7, wherein the control assembly comprises a retraction mechanism capable of switching the carrier from the open position of maximum expansion to the retracted position.
9. The ultrasound guiding catheter of claim 8, wherein the retraction mechanism includes a pull wire connected to the second end, the second end being switchable from the open position to the retracted position by pulling on the pull wire; or
The retraction mechanism includes a sleeve structure movably disposed on the catheter body, and the second end is switchable from the open position to the retracted position by actuating the sleeve structure to move relative to the catheter body.
10. The ultrasound guided catheter of any of claims 3-9, wherein the outer wall of the catheter body is further provided with a groove for receiving the carrier.
11. The ultrasound guiding catheter of claim 5, wherein the outer wall of the catheter body is further provided with a groove for receiving the carrier, the groove is provided with a recess therein for receiving the second end, and the push wire extends out of the groove from a surface of the recess and is connected with the second end.
12. The ultrasound guide catheter of claim 9, wherein the outer wall of the catheter body is further provided with a groove for receiving the carrier, the groove having a recess therein for receiving the second end; the pull wire extends out of the groove through the surface of the concave part and is connected with the second end.
13. The ultrasound guide catheter of any of claims 3-9, 11, 12, wherein the carrier includes a pivot by which the carrier can be rotated to a preset open position, the second end being integrally formed with the pivot.
14. The ultrasound guiding catheter of claim 13, wherein the carrier is integrally formed with the catheter body, and wherein the cable for connecting the transducer unit has no exposed portion between the carrier and the catheter body.
15. The ultrasound-guided catheter of claim 6, wherein the carrier is S-shaped, and when the carrier is in the open position, portions of the carrier on either side of the folded region are displaced in the axial direction of the catheter body and the orientation of the transducer elements on the portions are uniform.
16. The ultrasound guided catheter of claim 3, wherein the carrier is of a horn-like configuration and is foldably disposed within the catheter body, and wherein the ultrasound imaging assembly further comprises a support member for supporting the carrier, the support member being disposed within the catheter body and being movable relative to the catheter body by actuation of the control assembly to flares the second end out of the catheter body.
17. The ultrasound guided catheter of claim 9, wherein the carrier is a horn-like structure, the ultrasound imaging assembly further comprising a support for supporting the carrier, the support being capable of maximally expanding the carrier to the open position relative to the catheter body in the absence of an external force; the carrier is collapsibly disposed within the sleeve structure as the sleeve structure is moved distally of the catheter body.
18. The ultrasound-guided catheter of claim 2, wherein the carriers are symmetrically distributed about a center of the catheter body.
19. The ultrasound guiding catheter of claim 2, wherein at least one transducer of the transducer units is independently controllable.
20. An ultrasound guided puncture system comprising an ultrasound guided catheter according to any of claims 2-19.
21. The ultrasonically guided puncture system of claim 20, further comprising an adjustable bent sheath tubing 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 dilator body comprises a second working channel through which a puncture needle of the puncture needle assembly can pass for puncture; the dilator body is connected with a second control mechanism of the dilator assembly;
the catheter body is the sheath body or the dilator body.
22. The ultrasound-guided puncture system of claim 1 or 21, further comprising a length adjuster, wherein the puncture needle assembly comprises a third steering mechanism, and wherein the length adjuster is disposed between the third steering mechanism and the second steering mechanism of the dilator assembly, and wherein the length of the puncture needle extending out of the dilator body is adjusted by adjusting the length adjuster to adjust the distance between the second steering mechanism and the third steering mechanism.
23. The ultrasound-guided puncture system of claim 22, wherein the length adjuster is threadably coupled to one of the second and third steering mechanisms, and wherein the length of the puncture needle extending out of the dilator body is adjusted by rotating the length adjuster.
24. The ultrasound-guided puncture system of claim 23, wherein the thread of the length adjuster is provided with a mark, the housing of the one of the second and third control mechanisms is correspondingly provided with a scale, 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.
25. The ultrasonically guided lancing system of claim 22, wherein the third steering mechanism further comprises an operator and a guide channel, the operator being positioned within the guide channel and movable within the guide channel to cause the lancet to telescope.
26. The ultrasound-guided puncture system of claim 1 or 21, wherein the puncture needle assembly comprises a third steering mechanism, the third steering mechanism further comprising an energy storage assembly that is operable on the puncture needle to push the distal end of the puncture needle out of the dilator body.
27. The ultrasound-guided lancing system of claim 26, wherein the third steering mechanism further includes an operator and a guide channel, the operator being located within the guide channel and movable within the guide channel to lock or unlock movement of the lancet.
28. The ultrasound-guided puncture system of claim 25 or 27, wherein the third manipulation mechanism further comprises a limiting structure, the limiting structure comprising a limiting member disposed on the operation member and a stop member cooperating with the limiting member, the limiting member cooperating with the stop member to lock the puncture needle in a locked position.
29. The ultrasound-guided lancing system of claim 28, wherein the limit structure further comprises a first resilient member capable of applying a force to the operating member to maintain the limit member and the stop member in abutment with each other in the locked position.
30. The ultrasound-guided puncture system of claim 28, wherein at least one of the stop and the retainer includes a guide ramp, the stop and the retainer being positionable in the locked position, and thereby locking the puncture needle, guided by the guide ramp during positioning of the puncture needle in the locked position.
31. The ultrasound-guided puncture system of claim 28, wherein the operator includes a channel through which the stop member passes, the stop member being capable of passing through the channel when tissue puncture is desired, such that the distal end of the puncture needle extends out of the dilator body.
32. The ultrasound-guided puncture system of claim 28, wherein the energy storage assembly of the third actuating mechanism comprises a second resilient member, the stop member being disposed on the puncture needle, the second resilient member having one end abutting the stop member and the other end abutting the third actuating mechanism; when the puncture needle is in the locking position, the limiting piece is matched with the stop piece, so that the second elastic piece is in a compressed state, and the motion of the puncture needle is limited.
33. The ultrasonically guided lancing system of any one of claims 29-32, wherein the proximal end of the lance is provided with a liquid injection connector, and the stop are able to be placed in the locked position by pulling the liquid injection connector.
CN202211478594.8A 2022-11-24 2022-11-24 Ultrasound guide catheter and ultrasound guided puncture system Pending CN115568919A (en)

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