Intravascular ultrasonic catheter and ultrasonic diagnosis system

Abstract

The utility model discloses an intravascular ultrasound catheter and an ultrasound diagnosis system, the intravascular ultrasound catheter comprises a tip end, an imaging tube section and a conveying tube section which are arranged in sequence from the far end to the near end, and the tip end, the imaging tube section and the conveying tube section are internally provided with guide wire cavities for a guide wire to penetrate; core part cavities are formed in the imaging pipe section and the conveying pipe section, transducer core parts are arranged in the core part cavities, and ultrasonic transducers are arranged at the far ends of the transducer core parts; a transition part is arranged at the far end of the conveying pipe section, so that the conveying pipe section can generate local deformation; the guide wire control component allows the guide wire to move in the operating state, inhibits the guide wire from moving in the locking state, and limits the guide wire at the position away from the ultrasonic transducer as a whole. The intravascular ultrasonic catheter can be bent according to the physiological curvature of a human blood vessel, has the capability of easily passing through a tortuous blood vessel, reduces the risk of pressing the blood vessel and peripheral tissues, effectively reduces the influence of signal shielding caused by a guide wire, and realizes full-angle scanning of the ultrasonic catheter.

Description

Technical Field

[0001] The utility model relates to the technical field of ultrasonic catheters, and more specifically, to an intravascular ultrasonic catheter. In addition, the utility model also relates to an ultrasonic diagnostic system comprising the intravascular ultrasonic catheter. Background Art

[0002] IVUS (Intra Vascular UltraSound) catheter is an interventional medical device for cross-sectional scanning inside blood vessels, which can help doctors perform preoperative diagnosis and postoperative evaluation of vascular lesions. IVUS catheters are mainly divided into mechanical rotation type and electronic phased array type. Mechanical rotation IVUS catheters usually use a single transducer assembly to achieve cross-sectional scanning inside the target blood vessel through the rotation of the transducer.

[0003] When targeting peripheral blood vessels, especially those with relatively thicker diameters such as the iliac vein, carotid artery, aorta, and lower limb artery, a larger catheter can usually be selected. For IVUS catheters, this reduces the difficulty of implementing related catheter products, and the relatively large catheter diameter can also provide more space for the transducer. Larger transducers can often bring better imaging effects, and the mechanical properties of the catheter body will also be improved at the same time. But at the same time, on the one hand, larger catheters tend to have harder bodies and are not easy to pass through areas with higher degrees of curvature, and when the body of the tube is bent to a large extent, it may cause greater friction with other instruments used in conjunction, or may increase pressure on directly contacted blood vessels and surrounding tissues. On the other hand, larger catheters are used in conjunction with larger diameter guide wires, which aggravates the signal blocking problem caused by the guide wire.

[0004] In summary, how to provide a catheter that is easy to pass through tortuous blood vessels, reduce pressure on blood vessels and surrounding tissues, and reduce the signal shielding effect of the guidewire is an urgent problem to be solved by technical personnel in this field. Utility Model Content

[0005] In view of this, an object of the present invention is to provide an intravascular ultrasound catheter to solve at least one problem existing in the prior art. Another object of the present invention is to provide an ultrasound diagnostic system including the intravascular ultrasound catheter.

[0006] In order to achieve the above purpose, the utility model provides the following technical solutions:

[0007] An intravascular ultrasound catheter, comprising:

[0008] A tip, an imaging tube section and a delivery tube section are sequentially arranged from the distal end to the proximal end;

[0009] The tip, the imaging tube section and the delivery tube section are all provided with a guidewire cavity, and the guidewire cavity is used for the guidewire to penetrate;

[0010] The imaging tube section and the transport tube section are both provided with a core cavity, a transducer core is provided in the core cavity, and the distal end of the transducer core is an ultrasonic transducer;

[0011] A transition portion is provided at the distal end of the delivery pipe section, the transition portion is arranged away from the core cavity, and the transition portion is recessed toward the axial direction of the delivery pipe section so that the delivery pipe section can be locally deformed at the transition portion;

[0012] A guidewire control component is connected to the guidewire in the guidewire cavity, and the guidewire control component adjusts the guidewire to a locked state or an operating state. The guidewire control component allows the guidewire to move in the operating state, and the guidewire control component inhibits the movement of the guidewire in the locked state and limits the guidewire to a position that is overall far away from the ultrasonic transducer.

[0013] Preferably, the transducer core is capable of rotating and / or moving within the core cavity;

[0014] The guide wire control component limits the distal end of the guide wire to the proximal end of the imaging tube segment or the distal end of the delivery tube segment in a locked state, so that the guide wire avoids the detection range of the ultrasonic transducer.

[0015] Preferably, a plurality of transition portions are provided at the distal end of the delivery pipe segment, wherein the transition portion is a notch provided on the delivery pipe segment, the plurality of notches are arranged in a collinear manner and divide the guidewire cavity into multiple sections, and the notches are stretched or compressed to facilitate local deformation of the delivery pipe segment.

[0016] Preferably, the tip has a first position for accommodating the distal end of the guide wire, the proximal end of the imaging tube segment or the distal end of the delivery tube segment has a second position for accommodating the distal end of the guide wire, the guide wire control component allows the distal end of the guide wire to move to the first position or move from the first position to the second position in an operating state, and the guide wire control component restricts the distal end of the guide wire to the second position in a locked state;

[0017] When the guidewire control component is in a locked state, the ultrasonic transducer is activated.

[0018] Preferably, the tip is provided with a visualization mark at the first position, and the guidewire control component allows the distal end of the guidewire to be withdrawn from the outside of the catheter to be aligned with the visualization mark in an operating state.

[0019] Preferably, the sum of the length of the tip and the length of the imaging tube segment is L1, the maximum length that the guidewire control component can drive the distal end of the guidewire to move in the ultrasound catheter is L3, L3≤L1±5mm, and the distance between the second position and the distal end of the tip is L3;

[0020] The distance between the position of the ultrasonic transducer and the distal end of the tip is L2, and the distance between the transition portion and the distal end of the tip is L4, wherein: L2<L3<L4.

[0021] Preferably, the proximal end of the delivery tube segment is connected to the guidewire control component via a shunt, the outer layer of the guidewire control component is connected to the shunt, and the inner layer of the guidewire control component is movable relative to its outer layer and is used to connect the guidewire;

[0022] The flow divider is also connected to a core retraction component, the outer layer of the core retraction component is connected to the flow divider, and the inner layer of the core retraction component is movable relative to the outer layer thereof and is connected to the transducer core.

[0023] Preferably, the inner layer of the core retraction component and the inner layer of the guidewire control component are both provided with length marks, and the outer layer of the core retraction component and the outer layer of the guidewire control component are both transparent shells to facilitate reading of the length marks.

[0024] Preferably, the proximal end of the guidewire control component is connected to a locking component, the locking component comprises an extrusion piece sleeved on the inner layer of the guidewire control component, the distal end of the extrusion piece is connected to a non-return piece, the extrusion piece can rotate relative to the non-return piece to radially squeeze the guidewire to prevent liquid reflux, specifically including preventing reverse gushing of blood during use;

[0025] The proximal end of the extrusion piece is connected with a locking piece, and the locking piece can be rotated relative to the extrusion piece to lock the proximal end of the guide wire.

[0026] The utility model also provides an ultrasonic diagnostic system, comprising a host system, a catheter connector and an intravascular ultrasonic catheter as described in any one of the above items, wherein the proximal end of the intravascular ultrasonic catheter is connected to the catheter connector, and the catheter connector is used to connect to the host system;

[0027] The host system has a display module, and the display module is at least used to display the image information collected by the ultrasonic transducer.

[0028] The utility model provides an intravascular ultrasound catheter, comprising a tip, an imaging tube section, and a delivery tube section, which are arranged in sequence from the distal end to the proximal end. The tip, the delivery tube section, and the imaging tube section are all provided with a guidewire cavity, and the guidewire cavity is used for the guidewire to penetrate. When in use, the distal end of the guidewire is pushed to the designated position of the target blood vessel, and then the proximal end of the guidewire passes through the tip entrance and enters the imaging tube section and the delivery tube section, and the catheter is pushed to the target blood vessel position as a whole through the guidewire. The delivery tube section and the imaging tube section are both provided with a core cavity, and a rotatable transducer core is provided in the core cavity. The distal end of the transducer core is an ultrasonic transducer. When the catheter as a whole reaches the target blood vessel position, the ultrasonic transducer is used for scanning imaging to assist in preoperative diagnosis and postoperative evaluation of vascular lesion treatment. A transition portion is provided on the distal end of the guidewire cavity of the delivery tube section, and the transition portion is arranged away from the core cavity. The transition portion is recessed in a direction close to the axis of the delivery tube section to The outer diameter of the catheter is partially reduced, which facilitates the local deformation of the delivery tube section at the transition part, reduces the stress of the catheter itself when bending, and ensures the flexibility of the larger and higher-strength catheter. When the catheter enters the tortuous target blood vessel, the setting of the transition part can make the catheter as a whole easily conform to the physiological curvature of the human blood vessel, reduce the risk of compression on the blood vessel and surrounding tissues, and enhance the ability to pass through tortuous blood vessels; the guidewire control component is connected to the guidewire in the guidewire cavity, and is used to adjust the guidewire to a locked state or an operating state. If a signal shielding problem occurs, the guidewire control component is used to adjust the guidewire to an operating state so that it moves away from the ultrasonic transducer position, and then the guidewire control component is used to adjust the guidewire to a locked state, so that the ultrasonic transducer can perform full-angle scanning imaging; after the scanning imaging is completed, the guidewire control component is used to adjust the guidewire to an operating state, and the guidewire can be moved back to its original position in the catheter.

[0029] The above-mentioned intravascular ultrasound catheter can easily conform to the physiological curvature of human blood vessels, has the ability to pass through tortuous blood vessels, reduces the risk of compression on blood vessels and surrounding tissues, avoids vascular damage, effectively reduces the signal blocking effect caused by the guide wire, and realizes full-angle scanning of the ultrasound catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are only embodiments of the utility model. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0031] Figure 1 This is a schematic diagram of the structure of the intravascular ultrasound catheter provided by the utility model;

[0032] Figure 2A schematic diagram of the connection between the guide wire control component and the locking structure provided by the utility model;

[0033] Figure 3 A partial schematic diagram of the delivery pipe section provided by the utility model;

[0034] Figure 4 for Figure 3 AA section view;

[0035] Figure 5 for Figure 3 BB section view;

[0036] Figure 6 A bending state diagram of the intravascular ultrasonic catheter provided by the utility model;

[0037] Figure 7 This is another bending state diagram of the intravascular ultrasonic catheter provided by the utility model;

[0038] Figure 8 It is a schematic diagram of a guide wire blocking a signal in the prior art.

[0039] Figure 1-Figure 8 , the reference numerals include:

[0040] 1- tip; 2- imaging tube segment; 3- delivery tube segment; 4- diverter; 5- guidewire control component; 6- locking component; 7- core retraction component; 8- catheter connector;

[0041] 31-notch; 32-guidewire cavity; 33-core cavity;

[0042] 61-anti-return member; 62-extrusion member; 63-locking member. DETAILED DESCRIPTION

[0043] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.

[0044] The core of the utility model is to provide an intravascular ultrasound catheter that can easily conform to the physiological curvature of human blood vessels, has the ability to pass through tortuous blood vessels, reduces the risk of compression of blood vessels and surrounding tissues, avoids blood vessel damage, effectively reduces the signal shielding effect caused by the guide wire, and realizes full-angle scanning of the ultrasound catheter. Another core of the utility model is to provide an ultrasound diagnostic system including the above intravascular ultrasound catheter.

[0045] The intravascular ultrasound catheter provided by the utility model comprises a tip 1, an imaging tube section 2, a delivery tube section 3, and a guidewire control component 5. Please refer to Figure 1 , Figure 3-5 .

[0046] The tip 1, imaging tube section 2 and delivery tube section 3 are sequentially arranged from the distal end to the proximal end, that is, the imaging tube section 2 is arranged at the proximal end of the tip 1, and the delivery tube section 3 is arranged at the proximal end of the imaging tube section 2. The tip 1, the imaging tube section 2 and the delivery tube section 3 are all provided with a guidewire cavity 32, wherein the guidewire cavities 32 of the tip 1, the imaging tube section 2 and the delivery tube section 3 are connected and used to pass the guidewire. When used for ultrasonic diagnosis in interventional surgery, after establishing the blood vessel entrance, the distal end of the guidewire is pushed to the designated position of the target blood vessel, and then the proximal end of the guidewire is inserted into the guidewire entrance on the tip 1 at the distal position of the catheter, and the catheter is pushed forward along the guidewire as a whole to enter the corresponding position of the target blood vessel.

[0047] The imaging tube section 2 and the transport tube section 3 are both provided with a core cavity 33, the core cavities 33 in the two are connected and used to place the transducer core, the distal end of the transducer core is an ultrasonic transducer, and the ultrasonic transducer is used to collect image information of the target blood vessel.

[0048] In addition, a liquid injection port is provided at the proximal end of the core cavity 33, through which liquid is injected. A liquid outlet is provided at the distal end of the core cavity 33 to ensure that the transducer can be soaked in liquid and the effectiveness of the transducer operation is ensured. The liquid here can be physiological saline.

[0049] In a specific embodiment, the tip 1 is set to a relatively flexible material, such as Pebax (block polyetheramide resin), TPU (thermoplastic polyurethane elastomer), PA (polyamide resin), LDPE (low-density polyethylene) or a composite material, and is preferably set to a tapered structure with a thin distal end and a thick proximal end to facilitate the passage of the guide wire. In addition, the distal end of the tip 1 is processed into a smooth rounded corner or chamfer to avoid scratching or scraping the blood vessel when passing through the stenotic area of ​​the lesion.

[0050] The tube body material of the imaging tube segment 2 is preferably a material with low acoustic signal absorption / reflection or good flexibility, such as Pebax, HDPE (high-density polyethylene), so that the distal end of the ultrasound catheter has good softness.

[0051] The delivery pipe section 3 is the main delivery part of the ultrasonic catheter, and is preferably made of a relatively high-strength material such as PEEK (polyetheretherketone) and PI (polyimide), so that the delivery pipe section 3 can provide better support and force conduction, and the proximal end of the ultrasonic catheter has better support.

[0052] Optionally, the delivery pipe section 3 may be in the form of a braided pipe, and the strength and mechanical properties of the delivery pipe body may be improved by a metal mesh or a spring coil inside the pipe.

[0053] Optionally, the wall thickness of the tube body of the conveying tube segment 3 can be set to be greater than the wall thickness of the tube body of the imaging tube segment 2 to improve the strength of the tube body of the conveying tube.

[0054] Optionally, an inner lining layer is provided in the guidewire cavity 32 corresponding to both the imaging tube segment 2 and the conveying tube segment 3. The inner lining layer can be set to PTFE (polytetrafluoroethylene) material to reduce the friction between the inner wall of the guidewire cavity and the guide wire.

[0055] The distal end of the delivery tube segment 3 is provided with a transition portion, which is arranged away from the core cavity 33 and does not affect the normal operation of the transducer core in the core cavity 33. For example, the transition portion is distributed at the distal end of the delivery tube segment 3, and is specifically shaped as a groove distributed on the outer surface of the delivery tube. The groove is not connected to either the guidewire cavity 32 or the core cavity 33, and is only used to adjust the material hardness of the distal end of the delivery tube segment 3 so that the delivery tube segment 3 can easily bend in accordance with the physiological curvature to pass through the tortuous blood vessels, reduce the risk of compressing the blood vessels and their surrounding tissues, and reduce friction with other supporting instruments. The density and range of the specific transition portion distribution are flexibly set according to the clinical needs for the degree of curvature of the catheter, without too many restrictions.

[0056] The transition portion is recessed toward the axial direction of the delivery tube segment 3 to facilitate local deformation of the delivery tube segment 3 on the transition portion. When a catheter with a large diameter and high strength enters the target blood vessel under the guidance of the guide wire, the setting of the transition portion can reduce the overall hardness of the ultrasonic catheter, making it easy for the catheter as a whole to bend in accordance with the physiological curvature of the human blood vessels to pass through tortuous blood vessels, thereby reducing the risk of compressing the blood vessels and their surrounding tissues and reducing friction with other supporting instruments.

[0057] The overall bendability of the ultrasound catheter can be referred to Figure 6-7 Under the action of the transition part, the catheter as a whole is easy to bend to pass through tortuous blood vessels. The bending of the catheter in the figure is only for illustration. The degree of bendability of the catheter as a whole is related to the setting range, size, distribution density, etc. of the transition part, and is not limited to the figure.

[0058] The transition portion is recessed toward the axial direction of the delivery pipe segment 3, that is, the local outer diameter of the delivery pipe segment 3 is smaller. The smaller here means compared with the overall outer diameter of the delivery pipe segment 3. By locally reducing the outer diameter of the delivery pipe segment 3, the stress of the catheter body itself during bending is reduced, and its softness is increased, thereby facilitating the improvement of its ability to pass through tortuous blood vessels.

[0059] When the guide wire is passed through the ultrasonic catheter in vitro, the transition area is kept substantially straight during the process in which the proximal end of the guide wire passes through the transition area. If necessary, the ultrasonic catheter can be slightly bent manually to ensure that the guide wire passes through the entire segmented area of ​​the guide wire cavity 32 conveniently and accurately.

[0060] After the catheter follows the guide wire into the target blood vessel, the transducer core in the core cavity 33 rotates to drive the ultrasonic transducer to perform scanning imaging to obtain spiral continuous image frames, and complete image information of the target blood vessel is obtained through further processing.

[0061] Optionally, the transition portion is recessed toward the axis of the conveying pipe section 3 to form an arc-shaped groove, a square groove, a trapezoidal groove, etc., so as to change the local outer diameter of the conveying pipe section 3 and facilitate the bending of the conveying pipe section 3.

[0062] In some embodiments, the transition portion is distributed at the distal end of the delivery tube segment 3, and is specifically shaped as a groove distributed on the outer surface of the delivery tube. The groove is not connected to either the guide wire cavity 32 or the core cavity 33, and is only used to adjust the material hardness of the distal end of the delivery tube segment 3 so that the delivery tube segment 3 can easily bend to conform to the physiological curvature to pass through tortuous blood vessels, reduce the risk of compressing the blood vessels and their surrounding tissues, and reduce friction with other supporting instruments.

[0063] The guidewire control component 5 is connected to the guidewire in the guidewire cavity 32, and is used to adjust the guidewire to a locked state or an operating state. When in use, the distal end of the guidewire is pushed to the designated position of the target blood vessel, and the proximal end of the guidewire passes through the entrance of the tip 1 and enters the guidewire cavity 32 in the imaging tube segment 2 and the delivery tube segment 3, and the catheter is pushed to the target blood vessel through the guidewire; after the catheter reaches the target position, if the image collected by the ultrasonic transducer shows a signal shielding problem, the guidewire control component 5 is used to move the guidewire away from the original position;

[0064] Specifically, the guidewire control component 5 adjusts the guidewire to be in an operating state so that the guidewire can move. When the guidewire moves to a state where it no longer blocks the ultrasonic transducer imaging, the guidewire control component 5 adjusts the guidewire to be in a locked state to suppress the movement of the guidewire and restrict the guidewire to a position away from the ultrasonic transducer as a whole, so as to facilitate the ultrasonic transducer to perform full-angle scanning and imaging, avoid the problem of guidewire obstruction, and ensure the integrity and comprehensiveness of the imaging. After completing the scanning and imaging, the guidewire control component 5 adjusts the guidewire to be in an operating state, and at this time the guidewire can move in the operating state to withdraw to its original position in the catheter.

[0065] In this embodiment, during the process of withdrawing the guide wire to its original position in the catheter, the guide wire control component 5 may simply release the lock on the guide wire and manually push the guide wire to withdraw it to its original position; alternatively, the guide wire control component 5 may both release the lock on the guide wire and push the guide wire to withdraw it to its original position. The intravascular ultrasound catheter comprises a tip 1, an imaging tube section 2, and a delivery tube section 3 which are arranged in sequence from the distal end to the proximal end. The tip 1, the delivery tube section 3, and the imaging tube section 2 are all provided with a guidewire cavity 32, and the guidewire cavity 32 is used for the guidewire to penetrate. When in use, the distal end of the guidewire is pushed to the designated position of the target blood vessel, and then the proximal end of the guidewire passes through the entrance of the tip 1 and enters the imaging tube section 2 and the delivery tube section 3, and the catheter is pushed to the target blood vessel through the guidewire. The delivery tube section 3 and the imaging tube section 2 are both provided with a core cavity 33, and a rotatable transducer core is provided in the core cavity 33. The distal end of the transducer core is an ultrasonic transducer. When the catheter as a whole reaches the target blood vessel, the ultrasonic transducer is used for scanning imaging to assist in preoperative diagnosis and postoperative evaluation of vascular lesion treatment. A transition portion is provided at the distal end of the guidewire cavity 32 of the delivery tube section 3, and the transition portion is arranged away from the core cavity 33, and the transition portion is close to the axis of the delivery tube section 3. The guide wire direction is recessed to partially reduce the outer diameter of the catheter, facilitate the local deformation of the delivery tube section 3 at the transition part, reduce the stress of the catheter itself when bending, and ensure the flexibility of the catheter with a larger size and higher strength. When the catheter enters the tortuous target blood vessel, the setting of the transition part can make the catheter as a whole easily conform to the physiological curvature of the human blood vessel, reduce the risk of compression on the blood vessel and surrounding tissues, and enhance the ability to pass through tortuous blood vessels; the guide wire control component 5 is connected to the guide wire in the guide wire cavity 32, and is used to adjust the guide wire to a locked state or an operating state. If a signal blocking problem occurs, the guide wire control component 5 is used to adjust the guide wire to an operating state so that it moves away from the ultrasonic transducer position, and then the guide wire control component 5 is used to adjust the guide wire to a locked state, so that the ultrasonic transducer can perform full-angle scanning imaging; after completing the scanning imaging, the guide wire is adjusted to an operating state by the guide wire control component 5, and the guide wire can be moved back to its original position in the catheter.

[0066] The above-mentioned intravascular ultrasound catheter can easily conform to the physiological curvature of human blood vessels, has the ability to pass through tortuous blood vessels, reduces the risk of compression on blood vessels and surrounding tissues, avoids vascular damage, effectively reduces the signal blocking effect caused by the guide wire, and realizes full-angle scanning of the ultrasound catheter.

[0067] Based on the above embodiments, in some embodiments, the transducer core can be rotatable and / or movable in the core cavity 33, and when the catheter as a whole enters the corresponding position of the target blood vessel, the ultrasonic transducer rotates and / or moves for scanning imaging.

[0068] The guide wire control component 5 limits the distal end of the guide wire to the proximal end of the imaging tube segment 2 or the distal end of the delivery tube segment 3 in a locked state, so that the guide wire avoids the detection range of the ultrasonic transducer.

[0069] In this embodiment, the transducer core can rotate and / or move in the core cavity 33 to meet the requirement of the ultrasonic transducer to collect images in all directions in the target blood vessel.

[0070] When signal blocking problems occur, the guide wire control component 5 can limit the distal end of the guide wire to the proximal end of the imaging tube segment 2 or the distal end of the delivery tube segment 3, so that the guide wire avoids the detection range of the ultrasonic transducer, ensuring the integrity and comprehensiveness of the ultrasonic transducer imaging, and limiting the extreme movement range of the distal end of the guide wire to avoid excessive movement affecting the subsequent process of withdrawing the guide wire to its original position.

[0071] Based on any of the above embodiments, a plurality of transition portions are provided at the distal end of the delivery pipe segment 3, and the transition portions are notches 31 provided on the delivery pipe segment 3. The plurality of notches 31 are arranged in a colinear manner and divide the guide wire cavity 32 into multiple sections. The notches 31 are stretched or compressed to facilitate local deformation of the delivery pipe segment 3.

[0072] Please refer to Figure 1 , Figure 3 , Figure 5 The distal end of the delivery pipe section 3 is provided with a plurality of transition portions, so that the delivery pipe section 3 can simultaneously meet the requirements of distal end flexibility and proximal end support.

[0073] When the guide wire enters the transition area in vitro, the area corresponding to the notch 31 remains basically straight, and the delivery tube is manually bent when necessary to ensure that the guide wire passes through the transition area smoothly and correctly and is smoothly delivered to the distal end of the catheter as a whole.

[0074] The transition portion is specifically a notch 31 arranged on the delivery tube segment 3. Multiple notches 31 are arranged in a colinear manner and divide the guidewire cavity 32 into multiple sections. When passing through a tortuous blood vessel, the notch 31 is stretched or compressed to facilitate local deformation of the delivery tube segment 3, so that the catheter as a whole has the ability to easily pass through the tortuous blood vessel.

[0075] Preferably, the distance between two adjacent notches 31 (the distance between the end of a preceding notch 31 and the beginning of a succeeding notch 31 adjacent thereto) and the length of a single notch 31 may be 5-10 mm.

[0076] On this basis, the total length L0 of the transition portion is preferably 30~70mm. If there is a relatively special clinical requirement for length, such as the need for the catheter to perform a "climbing" operation in a peripheral blood vessel, the sum of the length of the tip 1, the length of the imaging tube segment 2, and the length of the transition area on the delivery tube segment 3, L1+L0, is greater than the distance between the starting point of the bending area of ​​the peripheral blood vessel (i.e., the area where the catheter needs to perform a climbing operation) to the farthest point of the target blood vessel segment.

[0077] The two sides of the notch 31 are bent outward relative to the bottom thereof, such as Figure 2 As shown, the notch 31 is a trapezoidal structure, and chamfers and rounded corners can be provided at the bent parts to prevent the catheter from scratching the blood vessels.

[0078] On the basis of any of the above embodiments, the tip 1 has a first position for accommodating the distal end of the guide wire, the proximal end of the imaging tube segment 2 or the distal end of the delivery tube segment 3 has a second position for accommodating the distal end of the guide wire, the guide wire control component 5 allows the distal end of the guide wire to move to the first position or from the first position to the second position in the operating state, and the guide wire control component 5 limits the distal end of the guide wire to the second position in the locked state;

[0079] When the guidewire control component 5 is in the locked state, the ultrasonic transducer is activated.

[0080] Please refer to Figure 1 The tip 1 has a first position for accommodating the distal end of the guide wire, which is the guide wire entrance position on the tip 1 and is also the original position of the guide wire, while the proximal end of the imaging tube segment 2 or the distal end of the transport tube segment 3 has a second position for accommodating the distal end of the guide wire.

[0081] In one embodiment, the guidewire control component 5 allows the distal end of the guidewire to move from a first position to a second position in an operating state. In this state, the guidewire undergoes a fixed-length retraction process, causing the distal end of the guidewire to be retracted to a second position corresponding to the proximal end of the imaging tube segment 2 or the distal end of the delivery tube segment 3, so as to avoid the detection range of the ultrasonic transducer and prevent signal blocking problems.

[0082] In another embodiment, the guide wire control component 5 allows the distal end of the guide wire to move to a first position in an operating state. In this state, after the ultrasonic transducer acquires an image, the guide wire moves from a second position corresponding to the proximal end of the imaging tube segment 2 or the distal end of the delivery tube segment 3 to the first position. This state is a secondary fixed-length withdrawal process of the guide wire.

[0083] The fixed-length retraction of the guide wire limits the moving distance of the guide wire, ensuring that the retraction length of the guide wire does not affect the acoustic signal and does not affect the process of pushing the guide wire to the original position. If the catheter needs to perform a "mountain climbing" operation in the peripheral blood vessels, the fixed-length retraction of the guide wire can prevent the guide wire from being withdrawn to the point where the mountain needs to be climbed, making it difficult to withdraw it to the original position of the guide wire later.

[0084] The guidewire control component 5 limits the distal end of the guidewire to the second position in the locked state, so that the guidewire avoids the detection range of the ultrasonic transducer and avoids signal blocking problems. When the guidewire control component 5 is in the locked state, the ultrasonic transducer is started to collect a comprehensive and complete image.

[0085] Based on any of the above embodiments, the tip 1 is provided with a visualization mark at the first position, and the guidewire control component 5 allows the distal end of the guidewire to be withdrawn from the outside of the catheter to be aligned with the visualization mark in the operating state.

[0086] By setting the imaging mark at the first position, the relative position relationship between the guide wire and the distal end of the catheter can be corrected to provide a position reference for the subsequent withdrawal of the guide wire to the original position. After the distal end of the guide wire is withdrawn from the outside of the catheter to align with the imaging mark, the guide wire is withdrawn again to ensure that the guide wire can be withdrawn proximally to the proximal end of the imaging tube segment 2 or the distal end of the delivery tube segment 3 for the first time by a certain distance, and then withdrawn distally for the second time by this certain distance to withdraw to the position aligned with the imaging mark, that is, the original position of the guide wire.

[0087] On the basis of any of the above embodiments, the sum of the length of the tip 1 and the length of the imaging tube segment 2 is L1, the maximum length of the guide wire distal end that the guide wire control component 5 can drive to move in the ultrasound catheter is L3, L3≤L1±5mm, and the distance between the second position and the distal end of the tip 1 is L3;

[0088] The distance between the position of the ultrasonic transducer and the distal end of the tip 1 is L2, and the distance between the transition portion and the distal end of the tip 1 is L4, wherein: L2<L3<L4.

[0089] Please refer to Figure 1 , the sum of the length of the tip 1 and the length of the imaging tube segment 2 is L1, the maximum length that the guidewire control component 5 can drive the distal end of the guidewire to move in the ultrasound catheter is L3, and the maximum length L3 that the distal end of the guidewire moves in the ultrasound catheter is also the distance between the second position and the distal end of the tip 1;

[0090] In the initial state, the catheter enters the target position along the guide wire. At this time, the distal end of the guide wire will extend a distance compared to the distal end of the catheter, and this distance is not a fixed distance. The guide wire needs to be retracted for the first time to align the distal end of the guide wire with the distal end of the catheter by aligning the developing mark set at the first position of the tip 1, and then the guide wire is retracted a second time to make the guide wire retract a fixed distance, and then the guide wire is locked by the guide wire control component 5 so that the guide wire does not block the sound signal of the ultrasonic transducer.

[0091] In the above process, the total moving length of the guide wire in the two retraction processes is uncertain. Therefore, when the distal end of the guide wire is aligned with the distal end of the catheter after the first retraction, the secondary retraction of the guide wire is limited so that the fixed distance of the guide wire retraction is the maximum length L3 of the guide wire distal end moving in the ultrasonic catheter driven by the guide wire control component 5.

[0092] L3≤L1±5mm, so that the limit distance of the distal end of the guide wire is at the distal end of the delivery tube segment 3 or the proximal end of the imaging tube segment 2, avoiding the problem of excessive withdrawal of the guide wire and avoiding affecting the subsequent process of withdrawing the guide wire to the original position. 5mm here is a more preferred value, not limited to this, and the value changes made according to actual clinical conditions are also within the scope of protection of this application.

[0093] In addition, the distance between the position of the ultrasonic transducer and the distal end of the tip 1 is L2, and the distance between the transition portion and the distal end of the tip 1 is L4, wherein: L2<L3<L4, and the extreme position of the withdrawal of the distal end of the guide wire is limited between the ultrasonic transducer and the distal end of the delivery tube section 3, avoiding excessive withdrawal of the guide wire without blocking the detection range of the ultrasonic transducer.

[0094] Based on any of the above embodiments, the proximal end of the delivery tube segment 3 is connected to the guidewire control component 5 through the diverter 4, the outer layer of the guidewire control component 5 is connected to the diverter 4, and the inner layer of the guidewire control component 5 can move relative to its outer layer and is used to connect the guidewire.

[0095] Please refer to Figure 8 , when the prior art targets peripheral blood vessels, firstly, for peripheral blood vessels with large diameters, the guide wire used is relatively large in size, which will aggravate the signal shielding caused by the guide wire during scanning imaging; secondly, for certain specific lesion areas, complete and comprehensive imaging is required. Based on the above two situations, the present application adjusts the guide wire to an operating state through the guide wire control component 5, so that the guide wire moves to withdraw from the detection range of the ultrasonic transducer, avoids the problem of signal shielding, and ensures the integrity and comprehensiveness of the imaging.

[0096] Preferably, the guide wire control component 5 has good hardness and flexibility, and the material can be selected from PEEK, PI, Pebax, PA, etc.

[0097] For details, please refer to Figure 1 One end of the flow divider 4 is connected to the proximal end of the delivery tube section 3, and the other end is connected to the guide wire control component 5. The outer layer of the guide wire control component 5 is connected to the flow divider 4 to form a fixed connection, and the inner layer of the guide wire control component 5 is connected to the guide wire and can move relative to the outer layer. The guide wire can be synchronously withdrawn from the detection range of the ultrasonic transducer through the movement of the inner layer of the guide wire control component 5, so that the catheter is not blocked by the guide wire during scanning, and full-angle imaging scanning is performed.

[0098] Furthermore, after full-angle scanning imaging, the guide wire can be withdrawn to its original position by moving the inner layer of the guide wire control component 5 .

[0099] Optionally, a silicone tube, a heat shrink tubing or other structures may be provided at the connection position between the diverter 4 and the delivery pipe section 3 to release stress during use, thereby avoiding the problem of stress accumulation in the catheter during use.

[0100] Optionally, if it is determined based on actual conditions that the guide wire will not block the ultrasonic signal or only conventional scanning imaging is required, the guide wire control component 5 does not operate.

[0101] Optionally, the flow divider 4 may be a Y-shaped member or a T-shaped member, and may be flexibly designed according to actual conditions.

[0102] Based on any of the above embodiments, the diverter 4 is further connected to a core retraction component 7, the outer layer of the core retraction component 7 is connected to the diverter 4, and the inner layer of the core retraction component 7 can move relative to its outer layer and is connected to the transducer core.

[0103] Please refer to Figure 1 The core retraction component 7 here is a component that drives the transducer to move and rotate. The core retraction component 7 is provided with an inner and outer layer. The outer layer is connected to the diverter 4 to form a fixation, and the inner layer can move relative to the outer layer to realize the movement of the transducer core.

[0104] Preferably, a silicone rubber sealing component is provided between the outer layer and the inner layer of the core withdrawal component 7 for sealing to prevent gas or liquid from entering the outer layer structure.

[0105] Based on any of the above embodiments, the inner layer of the core withdrawal component 7 and the inner layer of the guide wire control component 5 are both provided with length marks, and the outer layer of the core withdrawal component 7 and the outer layer of the guide wire control component 5 are both transparent shells to facilitate reading of the length marks.

[0106] In this embodiment, the inner layer of the core withdrawal component 7 and the inner layer of the guide wire control component 5 are both provided with length marks, so as to facilitate the acquisition of the withdrawal distance of the core and the withdrawal distance of the guide wire.

[0107] Specifically, when the guide wire is withdrawn, under radiographic conditions, the guide wire control component 5 is used to adjust the guide wire to the operating state, and the guide wire is manually withdrawn for the first time so that the distal tip of the guide wire is substantially flush with the developing point of the tip 1 (substantially flush here means that the distal tip of the guide wire is flush with the developing point of the tip 1 or the distal tip of the guide wire exceeds the developing point of the tip 1 by a certain distance, and the certain distance may be 5 mm or other smaller distances);

[0108] When the distal end of the guide wire is substantially flush with the developing point of the tip 1, the guide wire is manually withdrawn for the second time, and the withdrawal distance of the guide wire is known through the mark on the inner layer of the guide wire control component 5. This withdrawal distance corresponds to the maximum length L3 that the guide wire distal end can move in the ultrasonic catheter driven by the guide wire control component 5 as described above, so that the guide wire exits the detection range of the ultrasonic transducer;

[0109] Then, the guide wire is locked by the guide wire control component 5 and locked at a position away from the ultrasonic transducer as a whole, and the ultrasonic transducer is started to collect images;

[0110] After the full-angle imaging is completed, the guide wire can be adjusted to the operating state through the guide wire control component 5 so that the guide wire can move to the original position.

[0111] The actual retraction distance of the guide wire is obtained through the length marking, so that medical staff can better control the retraction distance of the guide wire and make the actual retraction distance within the value range of L3 under the conditions of L3≤L1±5mm and L2<L3<L4, effectively eliminating the signal blocking problem caused by the guide wire and avoiding excessive retraction of the guide wire.

[0112] In addition, the setting of length marks can achieve the effect of controlling the fixed-length retraction of the guidewire, help the operator standardize the use of the instrument, provide clear operating methods, and reduce the signal obstruction of the guidewire while meeting the catheter's ability to pass through tortuous blood vessels.

[0113] When the core of the transducer is withdrawn, the core of the transducer can be moved by pulling the inner layer of the core withdrawal component 7, and the withdrawal distance of the core can be known through the markings on the inner layer.

[0114] On the basis of any of the above embodiments, the proximal end of the guidewire control component 5 is connected to a locking component 6, the locking component 6 includes an extrusion component 62 sleeved on the inner layer of the guidewire control component 5, the distal end of the extrusion component 62 is connected to a check member 61, and the extrusion component 62 can rotate relative to the check member 61 to radially extrude the guidewire to prevent liquid reflux;

[0115] The proximal end of the extrusion member 62 is connected to a locking member 63 , and the locking member 63 can rotate relative to the extrusion member 62 to lock the proximal end of the guide wire.

[0116] Please refer to Figure 1 The proximal end of the guide wire control component 5 is connected to a locking component 6, and the locking component 6 is used to lock the proximal end of the guide wire.

[0117] For details, please refer to Figure 2 The locking component 6 includes an extrusion piece 62 which is sleeved on the inner layer of the guide wire control component 5. The extrusion piece 62 rotates relative to the check piece 61. Specifically, the distal end of the extrusion piece 62 is threadedly connected to the check piece 61. The extrusion piece 62 is screwed to squeeze the silicone / rubber ring member provided between the extrusion piece 62 and the check piece 61, so as to radially squeeze the guide wire of the inner layer of the guide wire control component 5 to form a gas-liquid seal and prevent the liquid from flowing back and out.

[0118] The proximal end of the extrusion piece 62 is connected to a locking piece 63, and the locking piece 63 can rotate relative to the extrusion piece 62. Specifically, the proximal end of the extrusion piece 62 and the locking piece 63 are threadedly connected. The locking piece 63 is turned to squeeze the multi-petal copper chuck between the proximal end of the extrusion piece 62 and the locking piece 63, so as to lock the proximal end of the guide wire by squeezing the multi-petal copper chuck.

[0119] It should be noted that if the medical staff determines that the guide wire needs to be moved to guide the movement of the catheter based on the actual treatment situation, the guide wire can be loosened by the locking component 6.

[0120] In this embodiment, the anti-return member 61 is provided with an external thread, and the corresponding inner thread provided on the distal end of the extrusion member 62 is threadedly connected to the anti-return member 61; the locking member 63 is provided with an internal thread, and the corresponding outer thread provided on the proximal end of the extrusion member 62 is threadedly connected to the locking member 63. However, the threaded connection method is not limited to this, as long as the multi-petal copper chuck and the silicone / rubber ring can be squeezed by the rotation force to achieve the effect of locking the guide wire and preventing liquid backflow.

[0121] In addition to the above-mentioned intravascular ultrasonic catheter, the present invention also provides an ultrasonic diagnostic system including the intravascular ultrasonic catheter described in any of the above-mentioned embodiments. The intravascular ultrasonic diagnostic system also includes a host system and a catheter connector 8.

[0122] Please refer to Figure 1 The proximal end of the inner layer of the core retraction component 7 is connected to a catheter connector 8, and the catheter connector 8 here can realize the signal connection between the transducer core and the host system, and the signal connection between the core retraction component 7 and the host system. The host system receives the transducer reflection signal to obtain the target blood vessel status, and controls the core retraction component 7 through the host system to realize the rotation and movement of the transducer to achieve all-round blood vessel monitoring.

[0123] The host system has a display module, which is used at least to display image information collected by the ultrasonic transducer, so that the operator can know the specific situation of the lesion area in the blood vessel in time.

[0124] In addition, L in the figure is the effective length of the ultrasonic catheter, that is, the length of the tube entering the human body. This length can be set to 100~200cm. The specific length can be flexibly changed according to actual surgical needs, that is, catheters of different lengths can be customized according to actual clinical needs.

[0125] Next, the working method of the above-mentioned intravascular ultrasound diagnostic system is introduced, and the working method includes:

[0126] The intravascular ultrasound catheter is pushed along the guide wire, and the transition portion facilitates the delivery tube section 3 to pass through a region with a greater degree of curvature, so that the ultrasound transducer can be delivered to the target position;

[0127] In the operating state, the guidewire control component 5 allows the distal end of the guidewire to be retracted from the outside of the ultrasonic catheter to the distal end of the delivery tube section 3 or the proximal end of the imaging tube section 2 to avoid the detection range of the ultrasonic transducer and ensure that the ultrasonic transducer collects a comprehensive and complete image;

[0128] The operating state is switched to the locking state, and the ultrasonic transducer is started. When the guide wire is restricted to a position away from the ultrasonic transducer as a whole, the ultrasonic transducer is started to acquire images.

[0129] On the basis of the above-mentioned embodiment, the guidewire control component 5 allows the distal end of the guidewire to be retracted from the outside of the intravascular ultrasound catheter to the distal end of the delivery tube segment 3 or the proximal end of the imaging tube segment 2, including:

[0130] The guide wire is retracted to a first position aligned with the visualization mark in the tip 1; then,

[0131] The guide wire is withdrawn at a fixed length from the first position to a second position located at the distal end of the delivery tube segment 3 or the proximal end of the imaging tube segment 2 .

[0132] In this embodiment, the first withdrawal of the guide wire causes the distal end of the guide wire to withdraw to a first position aligned with the development mark at the distal end of the tip 1, so as to correct the relative positional relationship between the guide wire and the distal end of the catheter, so as to provide a position reference for the subsequent withdrawal of the guide wire;

[0133] The second withdrawal of the guide wire causes the guide wire to be withdrawn from the first position to a second position located at the distal end of the delivery tube segment 3 or the proximal end of the imaging tube segment 2 to avoid the detection range of the ultrasonic transducer. The value of the fixed-length withdrawal is L3.

[0134] In addition, it should be noted that the orientation or positional relationship indicated by "far or near" etc. in the present invention is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of simplifying the description and facilitating understanding, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. For the convenience of description, only the parts related to the relevant utility model are shown in the drawings. The end close to the operator (such as medical staff) is defined as the proximal end, and the end used to extend into the patient's body is defined as the distal end. For a single component, the end closer to the operator is the proximal end, and the end farther away from the operator is the distal end. When the distal end or proximal end of a component is not clearly specified, it should be understood as the proximal end or distal end of the catheter as a whole.

[0135] In the absence of conflict, the embodiments and features in the embodiments of the present invention can be combined with each other. As used in the present invention, "installed", "connected", "connected", and one element "set" on another element should be understood in a broad sense, usually only indicating that there is a connection, coupling, cooperation or transmission relationship between the two elements, and the two elements can be directly or indirectly connected, coupled, cooperated or transmitted through an intermediate element, or the two elements can be connected by energy or signal response, but cannot be understood as indicating or implying the spatial position relationship or direct contact relationship between the two elements, that is, one element can be in any orientation such as inside, outside, above, below or on one side of another element, unless the content clearly indicates otherwise. For ordinary technicians in this field, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0136] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0137] The above is a detailed introduction to an intravascular ultrasound catheter and ultrasound diagnostic system provided by the utility model. This article uses specific examples to illustrate the principle and implementation method of the utility model. The description of the above embodiment is only used to help understand the method and core idea of ​​the utility model. It should be pointed out that for ordinary technicians in this technical field, without departing from the principle of the utility model, the utility model can also be improved and modified, and these improvements and modifications also fall within the scope of protection of the claims of the utility model.

Claims

1. An intravascular ultrasound catheter, characterized in that: include: A tip, an imaging tube section and a delivery tube section are sequentially arranged from the distal end to the proximal end; The tip, the imaging tube section and the delivery tube section are all provided with a guidewire cavity, and the guidewire cavity is used for the guidewire to penetrate; The imaging tube section and the transport tube section are both provided with a core cavity, a transducer core is provided in the core cavity, and the distal end of the transducer core is an ultrasonic transducer; A transition portion is provided at the distal end of the delivery pipe section, the transition portion is arranged away from the core cavity, and the transition portion is recessed toward the axial direction of the delivery pipe section so that the delivery pipe section can be locally deformed at the transition portion; A guidewire control component is connected to the guidewire in the guidewire cavity, and the guidewire control component adjusts the guidewire to a locked state or an operating state. The guidewire control component allows the guidewire to move in the operating state, and the guidewire control component inhibits the movement of the guidewire in the locked state and limits the guidewire to a position that is overall far away from the ultrasonic transducer.

2. The intravascular ultrasound catheter according to claim 1, characterized in that: The transducer core is capable of rotating and / or moving within the core cavity; The guide wire control component limits the distal end of the guide wire to the proximal end of the imaging tube segment or the distal end of the delivery tube segment in a locked state, so that the guide wire avoids the detection range of the ultrasonic transducer.

3. The intravascular ultrasound catheter according to claim 1, characterized in that: A plurality of transition portions are provided at the distal end of the delivery tube segment, wherein the transition portions are notches provided on the delivery tube segment, the plurality of notches are arranged in a collinear manner and divide the guidewire cavity into a plurality of sections, and the notches are stretched or compressed to facilitate local deformation of the delivery tube segment.

4. The intravascular ultrasound catheter according to claim 1, characterized in that: The tip has a first position for accommodating the distal end of the guide wire, the proximal end of the imaging tube segment or the distal end of the delivery tube segment has a second position for accommodating the distal end of the guide wire, the guide wire control component allows the distal end of the guide wire to move to the first position or move from the first position to the second position in an operating state, and the guide wire control component restricts the distal end of the guide wire to the second position in a locked state; When the guidewire control component is in a locked state, the ultrasonic transducer is activated.

5. The intravascular ultrasound catheter according to claim 4, characterized in that: The tip is provided with a visualization mark at the first position, and the guidewire control component allows the distal end of the guidewire to be withdrawn from the outside of the catheter to be aligned with the visualization mark in an operating state.

6. The intravascular ultrasound catheter according to claim 4, characterized in that: The sum of the length of the tip and the length of the imaging tube segment is L1, the maximum length that the guidewire control component can drive the distal end of the guidewire to move in the ultrasound catheter is L3, L3≤L1±5mm, and the distance between the second position and the distal end of the tip is L3; The distance between the position of the ultrasonic transducer and the distal end of the tip is L2, and the distance between the transition portion and the distal end of the tip is L4, wherein: L2<L3<L4.

7. The intravascular ultrasound catheter according to claim 1, characterized in that: The proximal end of the delivery tube segment is connected to the guidewire control component via a shunt, the outer layer of the guidewire control component is connected to the shunt, and the inner layer of the guidewire control component can move relative to its outer layer and is used to connect the guidewire; The flow divider is also connected to a core retraction component, the outer layer of the core retraction component is connected to the flow divider, and the inner layer of the core retraction component is movable relative to the outer layer thereof and is connected to the transducer core.

8. The intravascular ultrasound catheter according to claim 7, characterized in that: The inner layer of the core retracting component and the inner layer of the guidewire control component are both provided with length marks, and the outer layer of the core retracting component and the outer layer of the guidewire control component are both transparent shells to facilitate reading of the length marks.

9. The intravascular ultrasound catheter according to claim 1, characterized in that: The guidewire control component includes a locking component, the locking component includes an extrusion piece sleeved on the inner layer of the guidewire control component, the distal end of the extrusion piece is connected to a non-return piece, and the extrusion piece can rotate relative to the non-return piece to radially squeeze the guidewire to prevent liquid reflux; The proximal end of the extrusion piece is connected with a locking piece, and the locking piece can be rotated relative to the extrusion piece to lock the proximal end of the guide wire.

10. An ultrasonic diagnostic system, characterized in that: It comprises a host system, a catheter connector, a guide wire and the intravascular ultrasound catheter according to any one of claims 1 to 9, wherein the proximal end of the intravascular ultrasound catheter is connected to the catheter connector, and the catheter connector is used to connect to the host system; The host system has a display module, and the display module is at least used to display the image information collected by the ultrasonic transducer.

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