Ultrasound-guided catheter and ultrasound-guided puncture system

By integrating ultrasound imaging components and length regulators on the catheter, the cumbersome catheter operation and puncture needle length control problems are solved, and safer and more efficient left atrial interventional therapy is achieved.

CN115568919BActive Publication Date: 2025-01-17SHANGHAI ARTECHMED MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202211478594.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2022-11-24
Publication Date
2025-01-17
Estimated Expiration
2042-11-24

AI Technical Summary

Technical Problem

When performing left atrial interventional treatment, the catheter operation in the prior art is complicated and requires multiple exchange of instruments, which increases the risk of puncture sites. The ultrasonic catheter cannot be universal to surgical instruments, which provides limited images, resulting in difficulty in positioning and operational interference.

Method used

An ultrasonic guide catheter and puncture system was designed, integrating an ultrasonic imaging assembly into the catheter body, combining an adjustable bent sheath, a dilator and a puncture needle assembly to achieve the contraction and opening of the catheter through the control assembly, providing a visual tissue structure. And solve the problem of puncture needle length control through a length adjuster.

Benefits of technology

Simplified surgical steps, reduced unnecessary puncture risks, provided better device positioning and operation guidance, and reduced risk of myocardial or surrounding tissue damage.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present invention provides an ultrasound-guided catheter and an ultrasound-guided puncture system, the 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 curved sheath assembly comprises a sheath body, the sheath 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 ultrasound imaging assembly comprises a plurality of carriers and a transducer unit arranged on the carrier, the carrier is arranged at the distal end of the catheter body, and has a retracted position and an open position, in the retracted position, the catheter body can safely pass through the tissue cavity; in the open position, at least a portion of the carrier is opened away from the catheter body; the control assembly can make the carrier between the retracted position and the open position. The present invention solves the existing problems of difficult positioning of instruments and space occupation of ultrasound catheters during human interventional surgery.
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Description

Technical Field

[0001] 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. Background Art

[0002] Under normal circumstances, the percutaneous catheter cannot directly reach the left atrium in an antegrade manner. Although it is possible to enter the left atrium in a retrograde manner through the two turns of the aortic valve and the mitral valve, the catheter operation is very troublesome. Therefore, in clinical interventional treatment of the left atrium, the right atrium of the heart is usually entered through the femoral vein, and then the atrial septum between the right atrium and the left atrium is punctured, a sheath is inserted as a channel, and the instrument is sent into the left atrium through the sheath.

[0003] At present, the commonly used method for establishing left atrial access is to complete femoral vein puncture, and then send the atrial septum puncture system tube with a fixed head shape into the right atrium via a guide wire, and then insert the atrial septum puncture needle after withdrawing the guide wire. Usually, the oval fossa is located under X-ray and punctured with a puncture needle, and then the puncture sheath is passed through the puncture point into the left atrium. After the puncture is completed, 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. During the entire process of establishing left atrial access, various instruments need to be exchanged many times. First, the atrial septum puncture system is put in place by the guide wire, and then the guide wire is withdrawn, and the atrial septum puncture needle is used to puncture the atrial septum, and then the puncture needle is withdrawn, and the atrial septum puncture system is withdrawn after the guide wire is sent through the atrial septum, and finally the sheath access is put in place by the guide wire. The entire access establishment process involves instruments such as the atrial septal puncture system, atrial septal puncture needle, guide catheter and sheath system. The steps are cumbersome and require multiple angiography, while also increasing the risk of unnecessary adverse events at the puncture site.

[0004] In addition, in actual operation, the doctor needs to judge the position of the instrument based on the feel feedback of the instrument in the patient and the planar image of the X-ray. The physiological structure of different patients is different, and the direction of the puncture needle is not easy to judge under the planar image of the X-ray, which makes the puncture difficult and risky. At the same time, before and after the puncture, 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. In addition, during the puncture, 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.

[0005] In addition, 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. Summary of the invention

[0006] 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.

[0007] In order to achieve the above-mentioned object, in a first aspect, 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;

[0008] 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;

[0009] 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;

[0010] 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 carrier is opened away from the catheter body in the open position;

[0011] The catheter body is the sheath body or the dilator body;

[0012] 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.

[0013] In a second aspect, the present invention provides an ultrasound guided catheter, comprising a catheter body, an ultrasound imaging component and a control component;

[0014] The catheter body includes a working channel for the passage of instruments;

[0015] 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;

[0016] 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.

[0017] Optionally, 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.

[0018] Optionally, the control component includes an expansion mechanism, which is connected to the second end, and the expansion mechanism can switch the carrier from the contracted position to the preset open position.

[0019] 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 relative to the catheter body to the preset open position by pushing the push wire.

[0020] Optionally, 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.

[0021] Optionally, the carrier can be expanded to the open position to the maximum extent relative to the catheter body without being subjected to external force.

[0022] Optionally, the 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.

[0023] Optionally, the retracting mechanism includes a pull wire, the pull wire is connected to the second end, and the second end can be switched from the open position to the retracted position by pulling the pull wire; or

[0024] 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.

[0025] Optionally, a groove for accommodating the carrier is further provided on the outer wall of the catheter body.

[0026] Optionally, 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.

[0027] Optionally, 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.

[0028] Optionally, the carrier includes a pivot portion, and the carrier can be rotated through the pivot portion to reach the preset open position, and the second end is formed integrally with the pivot portion.

[0029] Optionally, 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.

[0030] Optionally, 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.

[0031] Optionally, 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.

[0032] Optionally, the carrier is a trumpet-shaped structure, and 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.

[0033] Optionally, the carriers are symmetrically distributed around the center of the catheter body.

[0034] Optionally, at least one transducer in the transducer unit is independently controllable.

[0035] Based on this, the present invention also provides an ultrasound-guided puncture system, including the ultrasound-guided catheter as described above.

[0036] Optionally, the puncture system further comprises an adjustable curved sheath assembly, a dilator assembly and a puncture needle assembly;

[0037] 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;

[0038] 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;

[0039] The catheter body is the sheath body or the dilator body.

[0040] Optionally, the puncture system also includes a length adjuster, the puncture needle assembly includes a third control mechanism, and the length adjuster is arranged between the third control mechanism and the second control mechanism of the expander assembly. By adjusting the length adjuster, the distance between the second control mechanism and the third control mechanism is adjusted, thereby adjusting the length of the puncture needle extending out of the expander body.

[0041] Optionally, the length adjuster is threadedly 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.

[0042] Optionally, 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.

[0043] Optionally, 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 extend and retract.

[0044] Optionally, 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.

[0045] Optionally, 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.

[0046] Optionally, 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.

[0047] Optionally, the limiting structure further includes a first elastic member, which is capable of applying force to the operating member to keep the limiting member and the stop member in abutment against each other in the locking position.

[0048] Optionally, 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.

[0049] Optionally, 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 so that the distal end of the puncture needle extends out of the dilator body.

[0050] Optionally, 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.

[0051] Optionally, 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.

[0052] In a third aspect, the present invention provides a puncture needle assembly, comprising a puncture needle and a control mechanism, wherein the puncture needle is arranged on the control mechanism, and the puncture needle has a locked state and a released state, and the control mechanism comprises an energy storage assembly, an operating member and a limiting structure, wherein the energy storage assembly can act on the puncture needle to make the distal end of the puncture needle puncture tissue; the limiting structure can keep the puncture needle in the locked state, in which the puncture movement of the puncture needle into 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 assembly.

[0053] Optionally, 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.

[0054] Optionally, 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.

[0055] In a fourth aspect, the present invention provides a puncture system, which includes the above-mentioned puncture needle assembly.

[0056] Optionally, 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.

[0057] In a fifth aspect, 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, which 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.

[0058] The present invention provides an ultrasound-guided catheter and an ultrasound-guided puncture system, which have at least one of the following beneficial effects:

[0059] 1) By integrating the ultrasound imaging component into the catheter body, the anatomical morphology of the atrial septum can be intuitively presented, providing a visual tissue structure within the instrument range, so as to better locate the appropriate puncture point on the atrial septum, guide the operator's operation, reduce the risk of the operation, and facilitate the smooth progress of the operation;

[0060] 2) By integrating the ultrasound imaging component into the catheter body, the existing problems of difficult positioning of instruments and ultrasound catheter space occupation during human interventional surgery are solved;

[0061] 3) By adding a length adjuster between the second control mechanism of the expander assembly and the third control mechanism of the puncture needle assembly, the problem that the extended length of the 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 is solved. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0063] Figure 1 A basic structural diagram of an ultrasound guidance catheter provided in an embodiment of the present invention;

[0064] Figure 2 This is a schematic diagram of a closed carrier provided in Embodiment 1 of the present invention;

[0065] Figure 3 This is a schematic diagram of the carrier provided in Example 1 of the present invention when it is unfolded;

[0066] Figure 4 This is a partial enlarged view of the carrier provided in Example 1 of the present invention when it is unfolded;

[0067] Figure 5 A schematic diagram of a hinge provided in Embodiment 1 of the present invention;

[0068] Figure 6 A schematic diagram of a push-type carrier with grooves provided in Embodiment 1 of the present invention;

[0069] Figure 7 A schematic diagram of a push-type carrier with a recess provided in Embodiment 2 of the present invention;

[0070] Figure 8 A schematic diagram of a foldable carrier with a push wire provided in the second embodiment of the present invention;

[0071] Fig. 9 A schematic diagram of a foldable carrier with a sleeve provided in Embodiment 4 of the present invention;

[0072] Fig.10 A schematic diagram of a pop-up carrier with a pull line provided in Embodiment 3 of the present invention;

[0073] Fig.11 A schematic diagram of a front-pull type pop-up carrier with a recess provided in Embodiment 3 of the present invention;

[0074] Fig.12 A schematic diagram of a pop-up carrier with a recessed portion provided in the third embodiment of the present invention;

[0075] Fig.13 A schematic diagram of a pop-up carrier with an inclined groove provided in the third embodiment of the present invention;

[0076] Fig.14 A schematic diagram of a pop-up carrier with a sleeve provided in Embodiment 4 of the present invention;

[0077] Fig.15 A schematic diagram of closed storage of a pop-up carrier provided in a fourth embodiment of the present invention;

[0078] Fig.16A schematic diagram of an open-type storage of a pop-up carrier provided in a fourth embodiment of the present invention;

[0079] Fig.17 A schematic diagram of an S-shaped carrier with a sleeve provided in Embodiment 5 of the present invention;

[0080] Fig.18 A schematic diagram of an S-type carrier provided in Example 5 of the present invention;

[0081] Fig.19 A schematic diagram of a trumpet-shaped carrier provided in Embodiment 6 of the present invention;

[0082] Fig. 20 A schematic diagram of a trumpet-shaped carrier provided by a sixth embodiment of the present invention being received into a sleeve;

[0083] Fig.21 A top view of the trumpet-shaped sheet carrier provided in Example 6 of the present invention when it is unfolded;

[0084] Fig. 22 A top view of a folded trumpet-shaped sheet carrier provided in Embodiment 6 of the present invention;

[0085] Fig.23 A schematic diagram of an asymmetric distribution of linear carriers provided in an embodiment of the present invention;

[0086] Fig.24 A schematic diagram of the centrosymmetric distribution of linear carriers provided in an embodiment of the present invention;

[0087] Fig.25 A schematic diagram of the centrosymmetric distribution of S-shaped carriers provided in an embodiment of the present invention;

[0088] Fig.26 A schematic diagram of the arrangement of the transducer provided in an embodiment of the present invention;

[0089] Fig. 27 A schematic diagram of a puncture needle assembly provided by an embodiment of the present invention;

[0090] Fig.28 A schematic diagram of the scale on the third control mechanism provided in an embodiment of the present invention;

[0091] Fig.29 A schematic diagram of a push-button puncture assembly in a locked position provided in Embodiment 1 of the present invention;

[0092] Fig.30 A schematic diagram of a push-button puncture assembly when unlocked provided by Embodiment 1 of the present invention;

[0093] Fig.31 A schematic diagram of another push-button puncture assembly in a locked position provided in Embodiment 1 of the present invention;

[0094] Fig.32 A schematic diagram of another push-button puncture assembly when unlocked provided in the first embodiment of the present invention;

[0095] Fig.33 This is a schematic diagram of the pop-up puncture assembly provided in the second embodiment of the present invention when storing energy.

[0096] Fig.34 This is a schematic diagram of the pop-up puncture assembly provided in the second embodiment of the present invention after being popped out.

[0097] In the attached figure:

[0098] 1-sheath body; 2-carrier; 3-transducer unit; 4-push wire; 5-hinge; 6-cable; 7-groove; 8-pull wire; 9-recess; 10-sleeve structure; 11-support member;

[0099] 1-1-working channel; 2-1-first end of the carrier; 2-2-second end of the carrier;

[0100] 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 slope. DETAILED DESCRIPTION

[0101] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. In addition, the structure shown in the drawings is often a part of the actual structure. In particular, the emphasis of each drawing is different, and sometimes different scales are used.

[0102] The singular terms "one", "an" and "the" used in the present invention may include plural objects, unless the content clearly indicates otherwise. The term "or" used in the present invention is usually used to include the meaning of "and / or", unless the content clearly indicates otherwise. The term "several" used in the present invention is usually used to include the meaning of "at least one", unless the content clearly indicates otherwise. The term "at least two" used in the present invention is usually used to include the meaning of "two or more", unless the content clearly indicates otherwise. In addition, the terms "first", "second" and "third" are used only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second" and "third" may explicitly or implicitly include one or at least two of the features.

[0103] 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.

[0104] 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;

[0105] 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;

[0106] 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;

[0107] 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 carrier is opened away from the catheter body in the open position;

[0108] The catheter body is the sheath body or the dilator body, etc.

[0109] 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.

[0110] The ultrasonic guide catheter comprises a catheter body, an ultrasonic imaging component and a control component;

[0111] The catheter body includes a working channel for the passage of instruments;

[0112] 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;

[0113] 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.

[0114] With such configuration, 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 interventional 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. In addition, since 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.

[0115] Embodiment 1

[0116] Please refer to Figure 1-Figure 3 , the ultrasound guide catheter comprises a catheter body 1, an ultrasound imaging component and a control component;

[0117] The catheter body 1 includes a working channel 1-1 for the passage of instruments;

[0118] The ultrasonic imaging assembly includes a plurality of carriers 2 and a transducer unit 3 disposed on the carriers 2. The carriers 2 are disposed 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. Figure 2 In the open position, at least a portion of the carrier 2 is opened away from the catheter body 1, as shown Figure 3 As shown;

[0119] 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.

[0120] The definitions of "proximal end" and "distal end" herein are as follows: "proximal end" generally refers to the end of the medical device that is close to the operator during normal operation, and "distal end" generally refers to the end of the medical device that first enters the patient's body during normal operation. It should be understood that the working channel 1-1 is preferably not limited to the passage of a guide wire, but can also allow other instruments other than a guide wire to pass through.

[0121] Specifically, the ultrasonic imaging component is used to transmit and receive ultrasonic signals, analyze and output images. According to the single ultrasonic signals sent back by different transducer arrays, the host can perform image processing, splice the same parts according to the content of the graphics, and then output the integrated image under a large viewing angle, providing a larger field of view for the operation. In this embodiment, the ultrasonic imaging component can be placed in different host devices for treatment purposes and be compatible with them.

[0122] The ultrasonic imaging assembly includes a plurality of carriers 2 and a transducer unit 3 located on the carrier 2. The carrier 2 serves as a mounting platform for the transducer unit 3 and can be mounted on the distal end of the corresponding catheter body 1. During the operation, the carrier 2 follows the catheter body 1 to enter the cavity for the operation. The transducer unit 3 is arranged on the carrier 2 at the distal end of the sheath, and the cable is connected to the transducer unit 3 on the carrier 2 at the distal end of the catheter body 1, and is connected to the wiring in the control assembly at the proximal end of the catheter body 1, and then is transferred to the host of the ultrasonic system through the wiring of the control assembly.

[0123] Furthermore, the carrier 2 at least includes a first end 2 - 1 and a second end 2 - 2 , the first end 2 - 1 is connected to the catheter body 1 , and the second end can be located at the open position away from the catheter body 1 .

[0124] Furthermore, the 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.

[0125] For details, please refer to Figure 2-Figure 5 , 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. 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. When the ultrasound 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 attached to the catheter body 1.

[0126] Preferably, 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 .

[0127] Preferably, the carrier 2 includes a pivot portion, and the second end can be rotated away from the catheter body 1 to reach the preset open position through the pivot portion, and the second end is formed integrally with the pivot portion.

[0128] Preferably, 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. Preferably, 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.

[0129] In this embodiment, at least a portion of the cable 6 of the ultrasound imaging assembly is buried in the carrier 2 and electrically connected to the transducer unit 3, and at least a portion of the cable 6 drawn out from the carrier 2 is buried in the catheter body 1, and its proximal end is electrically connected to the connector. Preferably, the connector is located on the control assembly (such as the catheter control handle), and the connector can be connected to the ultrasound host module through the control assembly.

[0130] Preferably, the cable 6 is a flexible cable. In the retracted position, the portion of the cable 6 connected to the carrier 2 and the catheter body is located between the carrier 2 and the catheter body 1. During the rotation of the carrier 2 around the hinge 5, the portion of the flexible cable 6 can flip to a certain angle to ensure the connection between the transducer unit 3 and the host. Figure 3 , 4 shown.

[0131] In this embodiment, the carrier 2 can be installed in different forms, which can be a single carrier 2 or a combination of multiple carriers 2. When in use, 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.

[0132] For better, please refer to Figure 6 The outer wall of the catheter body 1 is also provided with a groove 7 for accommodating the carrier 2. When the ultrasonic imaging assembly is not needed, 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 will 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.

[0133] For further better information, please refer to Figure 7A groove 7 for accommodating the carrier is also provided on the outer wall of the catheter body, and a recess 9 is provided in the groove 7. 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.

[0134] Embodiment 2

[0135] Please refer to Figure 8 Different from the first embodiment, in this embodiment, 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.

[0136] In this embodiment, the control component can be a push wire 4 or a sleeve structure 10. 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 arranged on the catheter body 1, and 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.

[0137] Preferably, 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.

[0138] Embodiment 3

[0139] Please refer to Fig.10 Different from the above-mentioned embodiment, in this embodiment, 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.

[0140] Specifically, the control component includes a retracting mechanism, which can switch the carrier 2 from the open position that is maximally opened to the retracted position.

[0141] In this embodiment, the retracting mechanism includes a pull wire 8, and the pull wire 8 is connected to the second end 2-2. By pulling the pull wire 8, the second end 2-2 can be switched from the open position to the retracted position.

[0142] For better, please refer to Figure 11-Figure 12The outer wall of the catheter body 1 is also provided with a groove 7 for accommodating the carrier, and a recess 9 is provided in the groove, 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. When 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., recess 9) in the entire groove 7. This area is located at the extension of the pull wire 8, so that the carrier can be better folded, thereby deriving two ways of accommodating the carrier 2. Please refer to Fig.11 , the pull wire 8 is connected to the proximal end of the carrier 2, 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 Fig.12 The pull wire 8 is connected to the distal end of the carrier 2 , and the distal end of the carrier 2 is moved toward the surface of the catheter body 1 by pulling the pull wire 8 .

[0143] Alternatively, please refer 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, which can also enable the carrier to obtain a better retracting effect.

[0144] Embodiment 4

[0145] Please refer to Fig.14 Different from the aforementioned embodiment, in this embodiment, the retraction mechanism includes a sleeve structure 10, and 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.

[0146] Preferably, 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 .

[0147] Based on the above-mentioned embodiment 3 and embodiment 4, the present application also derives two ways of accommodating the carrier 2 (the carrier can be made of elastic material, such as spring sheet, nickel-titanium alloy, polymer). The carrier 2 includes a pivoting portion, which is arranged between the first end 2-1 and the second end 2-2. Please refer to Fig.15 , through the pivoting 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; or, please refer to Fig.16Through 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 storing the carrier 2 are suitable for the pull wire 8 or the sleeve structure 10 at the same time.

[0148] Similarly, a groove for accommodating the carrier 2 may also be provided on the outer wall of the catheter body 1 .

[0149] Embodiment 5

[0150] Please refer to Figure 17-Figure 18 , different from the above-mentioned embodiment, in this embodiment, the carrier 2 is S-shaped. When the carrier 2 is located in the open position, the parts of the carrier 2 located on both sides of the folding area are misaligned along the axial direction of the catheter body 1 and the transducer units 3 on the parts are in the same direction. By using an S-shaped carrier instead of a linear carrier, more transducers can be used to obtain an enhanced ultrasonic effect. The transducer units 3 are respectively installed on the inner and outer sides of the parts on both sides of the folding area of ​​the S-shaped carrier. After the S-shaped carrier is pushed to fold, the transducer units 3 on the inner and outer sides of the S-shaped carrier can have the same direction after folding. The transducer units 3 can be installed on both the inner and outer sides, and ultrasonic waves are emitted in the same direction at the same time, thereby obtaining a higher ultrasonic emission density and imaging effect.

[0151] Embodiment 6

[0152] Please refer to Fig.19 Different from the above-mentioned embodiment, in the present embodiment, the carrier 2 is a trumpet-shaped structure that can be movably arranged at the distal end of the catheter and can be folded and arranged in the catheter body 1, and the ultrasonic imaging component also includes a support member 11 for supporting the carrier 2, and 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 unfolded 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.

[0153] Alternatively, 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, see Figure 19-21The carrier 2 is a trumpet-shaped structure, and the ultrasonic imaging assembly also includes a support member 11 for support. The support members 11 are connected by flexible materials to form sectors, and folding folds are set on the flexible materials according to the sectors, and circuits are arranged and transducers are placed. The support member 11 can guide the flexible material between the support members 11 to the maximum extent to open to the open position relative to the catheter body 1 without external force; 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 arranged in the sleeve structure 10. The transducers set on the flexible material can form a single transducer array, and the ultrasonic transducers in all the sector-shaped areas can form a larger transducer array. Through the ultrasonic phased array technology, ultrasound in different directions is excited and received, and real-time imaging is achieved through the image algorithm. The imaging area is related to the unfolded geometric shape of the veneer, and the tissue structure in front of the distal end of the catheter body 1 can be seen.

[0154] In this embodiment, 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.

[0155] For a better optimized embodiment, refer to Figure 21-22 , the wires in the trumpet-shaped structure carrier 2 can be replaced by predetermined high-elastic sheets (such as spring steel, nickel-titanium metal, titanium alloy, etc.), and fixed rings can be placed to enhance the connection strength between the sheets and the connection strength between the sheets and the catheter body 1. The flexible material originally folded by sectors on the wires is eliminated, and the flexible circuit and transducer are directly arranged on the high-elastic sheet. This method can be applied to instruments with certain requirements for spatial structure. When the sleeve structure 10 moves toward the distal end of the catheter body 1, the high-elastic wire is gathered by the sleeve structure 10, so that the carrier 2 can be arranged in the sleeve structure 10 in a gathered manner. By adjusting the relative position of the sleeve structure 10 and the carrier 2, the degree of opening of the carrier can be controlled.

[0156] In all the embodiments described above, the carrier 2 may be single or multiple. The distribution of the carrier 2 may be biased to one side of the catheter body 1, such as Fig.23 , or they may be symmetrically distributed around the center of the catheter body 1, such as Figure 24-25 This application does not impose any restrictions on this. Considering the actual holding capacity and the overlap of ultrasonic coverage, the number of the carriers 2 is not more than 8.

[0157] In the described embodiment, a transducer unit 3 may include a single transducer or a plurality of transducer arrays, such as Fig.26. The transducer can be installed on the outside or inside of the carrier 2, and the interval d between multiple transducers on a single carrier 2 is between 0.2λ-1.2λ (λ is the wavelength of ultrasound emitted by the transducer). When the transducers form an array, the array can be composed of multiple transducers on a single carrier 2, or it can be composed of different transducers on multiple carriers 2. Multiple transducers can be grouped, and multiple transducers in a single group can 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 ultrasound system controls the transducer through the cable 6, so that the transducer array emits ultrasound waves in a specific sequence to reach the phased array effect, thereby enhancing the ultrasound imaging effect of a specific area.

[0158] In another aspect, the present invention provides an ultrasound-guided puncture system, comprising the ultrasound-guided catheter as described above.

[0159] Furthermore, the puncture system also includes an adjustable bending sheath assembly, a dilator assembly and a puncture needle assembly;

[0160] 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;

[0161] 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;

[0162] The catheter body is the sheath body or the dilator body.

[0163] In this embodiment, the dilator body is a hollow tubular structure, and has a second working channel inside for the puncture needle to enter and exit. Preferably, the distal end of the dilator body has a certain taper to facilitate passing through the atrial septum.

[0164] Please refer to Fig. 27The puncture system further includes a length adjuster 100, and 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). By adjusting the length adjuster 100, the distance between the second control mechanism and the third control mechanism 101 is adjusted, thereby adjusting the length of the puncture needle 102 extending out of the dilator body. By adjusting the relative position between the length adjuster 100 and the third control mechanism 101, 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.

[0165] By providing the length adjuster 100, the problem that it is difficult to judge the extended length of the traditional puncture needle 102 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 is solved.

[0166] 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.

[0167] Furthermore, 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. In this embodiment, the length adjuster 100 is threadedly connected to the third control mechanism 101.

[0168] For better, please refer to Fig.28, a mark 103 is provided at 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. When the length adjuster 100 is rotated, 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. For example, when the mark is aligned with the scale zero point, it means that when the puncture needle 102 is extended to the maximum stroke, the distal end of the puncture needle 102 is aligned with the distal end of the dilator body. For example, when the mark is aligned with the scale "3", it means that when the puncture needle 102 is extended to the maximum stroke, the puncture needle 102 exceeds the distal end of the dilator body by 3 units.

[0169] Optionally, 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.

[0170] Optionally, 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.

[0171] Optionally, 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.

[0172] Embodiment 1

[0173] Please refer to Figure 29-Figure 32 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 in an upper and lower manner. When the push button is pressed, the puncture needle 102 can remain coaxial with the dilator body. 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.

[0174] By pressing the push button, 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 .

[0175] Preferably, the movement amount of the operating member 104 along the pushing direction of the puncture needle 102 can be adjusted by adjusting the length of the guide groove, thereby adjusting the pushing amount of the puncture needle 102 .

[0176] As a first preferred example in this embodiment, please refer to Figure 29-30 The push button and the third operating mechanism are provided with the limiter 105 and the stopper 106 correspondingly. 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. At this time, 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.

[0177] As a second preferred example in this embodiment, please refer to Figure 31-32 The push button and the third operating mechanism are provided with the limiter 105 and the stopper 106 correspondingly. 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. At this time, 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.

[0178] Preferably, 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. 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 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., and this application does not limit this.

[0179] Preferably, at least one of the limit member 105 and the stop member 106 includes a guiding bevel 110. During the process of setting the puncture needle 102 in the locking position, 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.

[0180] Preferably, 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.

[0181] Embodiment 2

[0182] The difference between the above embodiment 1 is that, please refer to Fig.33 and Fig.34 In this embodiment, the stopper 106 is arranged on the puncture needle 102, the operating member 104 can move 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. 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; when the operating member 104 is pressed down, the limiter 105 is vertically staggered from the stopper 106, that is, the limiter 105 is no longer located on the travel of the stopper 106, so that the stopper 106 can pass through the channel, thereby facilitating the distal end of the puncture needle 102 to extend out of the dilator body.

[0183] Preferably, 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. 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.

[0184] Further preferably, the energy storage component of the third control mechanism 101 includes a second elastic member 108, such as Figure 33-34As shown, 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 control 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. Its structure includes but is not limited to a spring, a cylinder, an air bag, etc. Taking a spring as an example, Fig.33 As shown, before use, the puncture needle 102 is pulled back, the spring is compressed, and at the same time, the limiter 105 on the operating member 104 blocks the stopper 106, the puncture needle 102 is in a locked state, and energy storage is completed. Fig.34 As shown, when in use, the operating member 104 is pressed down, 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 higher speed to puncture the atrial septum, and the puncture is completed.

[0185] Preferably, 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 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 to ensure that the stop member 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.

[0186] Preferably, at least one of the limit member 105 and the stop member 106 includes a guiding bevel 110. During the process of setting the puncture needle 102 in the locking position, 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.

[0187] Preferably, 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.

[0188] In summary, the present invention provides an ultrasound-guided catheter, which can provide a visualized tissue structure within the range of the instrument 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. Based on this, the present invention also provides an ultrasound-guided puncture system, which solves the problem that the length of the 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 dilator assembly and the third control mechanism of the puncture needle assembly.

[0189] The above is only a preferred embodiment of the present invention and does not limit the present invention in any way. Any technician in the relevant technical field, without departing from the scope of the technical solution of the present invention, makes any form of equivalent replacement or modification to the technical solution and technical content disclosed in the present invention, which does not depart from the content of the technical solution of the present invention and still falls within the protection scope of the present invention.

Claims

1. An ultrasound-guided puncture system for interventional surgery, characterized in that: It 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; wherein at least a portion of the carrier is opened away from the catheter body, and an imaging field of view of the ultrasonic imaging assembly is determined based on an opening angle of the carrier relative to the axis of the catheter body; The catheter body is the sheath body or the dilator body; the control assembly being 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 carrier at least comprises 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, the control component can move the carrier away from the catheter body to the preset open position in the folding area or move the carrier from the open position away from the catheter body to the contracted position in the folding area, and the carrier is S-shaped, when the carrier is located at the open position, the parts of the carrier located at both sides of the folding area are misaligned along the axial direction of the catheter body and the transducer units on both sides of the folding area are in the same direction; The puncture needle assembly includes a third control mechanism, and the third control mechanism also includes an energy storage assembly, an operating member, a guide groove and a limiting structure, 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, and the limiting structure includes a limiting member arranged on the operating member and a stopper matched with the limiting member, and the limiting member cooperates with the stopper to lock the puncture needle in a locked position, 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 limiting structure further comprises a first elastic member, which is capable of applying a force to the operating member so as to keep the limiting member and the stop member in contact with each other in the locking position; The energy storage assembly includes a second elastic member, and 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 control 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.

2. The ultrasound-guided puncture system for interventional surgery according to claim 1, characterized in that: The control assembly includes an expansion mechanism connected to the second end, and the expansion mechanism can switch the carrier from the contracted position to the preset open position.

3. The ultrasound-guided puncture system for interventional surgery according to claim 1, characterized in that: The control assembly includes a retraction mechanism, which includes a sleeve structure. The sleeve structure is movably disposed on the catheter body, and 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.

4. The ultrasound-guided puncture system for interventional surgery according to any one of claims 1 to 3, characterized in that: The outer wall of the catheter body is also provided with a groove for accommodating the carrier.

5. The ultrasound-guided puncture system for interventional surgery according to any one of claims 1 to 3, characterized in that: 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.

6. The ultrasound-guided puncture system for interventional surgery according to claim 1, characterized in that: The carriers are symmetrically distributed around the center of the catheter body.

7. The ultrasound-guided puncture system for interventional surgery according to claim 1, characterized in that: At least one transducer in the transducer unit is independently controllable.

8. The ultrasound-guided puncture system for interventional surgery according to claim 1, characterized in that: The puncture system also includes a length adjuster, and the puncture needle assembly includes a third control mechanism. The length adjuster is arranged between the third control mechanism and the second control mechanism of the expander 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 expander body.

9. The ultrasound-guided puncture system for interventional surgery according to claim 8, characterized in that: The length adjuster is threadedly 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 can be adjusted by rotating the length adjuster.

10. The ultrasound-guided puncture system for interventional surgery according to claim 9, characterized in that: 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.

11. The ultrasound-guided puncture system for interventional surgery according to claim 8, characterized in that: The third control mechanism further comprises 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 extend and retract.

12. The ultrasound-guided puncture system for interventional surgery according to claim 1, characterized in that: At least one of the limiter and the stopper includes a guiding bevel. During the process of setting the puncture needle at the locking position, the limiter and the stopper can be set at the locking position through the guidance of the guiding bevel, thereby locking the puncture needle.

13. The ultrasound-guided puncture system for interventional surgery according to claim 1, characterized in that: The operating member comprises a channel for the stopper to pass through. When tissue puncture is required, the stopper can pass through the channel so that the distal end of the puncture needle extends out of the expander body.

14. The ultrasound-guided puncture system for interventional surgery according to claim 12 or 13, characterized in that: A liquid injection connector is arranged at the proximal end of the puncture needle, and the stopper and the limiting member can be arranged at the locking position by pulling the liquid injection connector.

Citation Information

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