Ultrasonic catheter and ultrasonic equipment

Abstract

The invention discloses an ultrasonic catheter and ultrasonic equipment, and relates to the technical field of medical equipment. A guide wire channel, a puncture guide wire channel and a core channel which are parallel to one another and not coaxial are arranged in the ultrasonic catheter, the puncture guide wire channel and the core channel are both arranged at the near end of the guide wire channel and are arranged side by side, and the puncture guide wire outlet is communicated with the puncture guide wire channel; the imaging core part is arranged in the core part channel and can rotate and / or move relative to the core part channel; the catheter withdrawing part comprises a connecting tube and a withdrawing inner tube, the connecting tube is fixedly arranged at the near end of the catheter main body, and the withdrawing inner tube is arranged at the near end of the imaging core part in a sleeving manner and can synchronously move with the imaging core part. The catheter body is directly provided with three channels, ultrasonic image recognition and puncture guide wire stretching can be directly conducted, and other catheters do not need to be used in a combined mode; the three channels are parallel to one another and are not coaxial, so that a guide wire passage adapting to a blood vessel occlusion scene can be established through the integrated catheter, and the catheter can be operated to rotate easily.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to an ultrasonic catheter and an ultrasonic device. BACKGROUND

[0002] In the treatment of chronic total occlusion (CTO) lesions, a guide wire needs to pass through or bypass the occluded segment to establish a guide wire channel across the complex lesion. In order to improve the visualization of the lesion site, the operator often needs to use an ultrasonic catheter. In the prior art, the establishment of a guide wire channel usually requires the combination of an ultrasonic catheter with a guide wire and a puncture guide wire, such as the combination of an intravascular ultrasound (IVUS) catheter and a single-lumen microcatheter, or the combination of an intravascular ultrasound (IVUS) catheter and a double-lumen microcatheter.

[0003] However, the existing combination catheter for establishing a guide wire channel is usually large in size, especially when the puncture guide wire needs to be adjusted to point in the target direction (mainly to extend towards the true lumen direction). On the one hand, the proximal torsion cannot be well transmitted to the distal end of the catheter in the body to change the puncture direction, and the patient's tissue is also easily damaged during the process. On the other hand, the torsion of the catheter requires the disassembly of the catheter and its connecting device to avoid the torsion of the ultrasonic assembly affecting the ultrasonic performance.

[0004] Therefore, the existing catheter for establishing a guide wire channel across the complex lesion has the problems of large overall size, complex operation, and difficulty in safely and conveniently transmitting the torsion and adjusting the angle of the catheter. How to design an ultrasonic catheter that is easy to operate is a technical problem that needs to be solved by those skilled in the art. SUMMARY

[0005] Therefore, the purpose of the present application is to provide an ultrasonic catheter and an ultrasonic device comprising the ultrasonic catheter, which is easy to operate.

[0006] To achieve the above-mentioned purpose, the present application provides the following technical solutions:

[0007] In one aspect, the present application provides an ultrasonic catheter, comprising: a catheter main body having a guide wire channel, a puncture guide wire channel and a core channel which are parallel to each other and not coaxial, the guide wire channel is arranged at the distal end of the catheter main body, the puncture guide wire channel and the core channel are arranged at the proximal end of the guide wire channel and are arranged side by side, a puncture guide wire outlet is arranged on the catheter main body and communicates with the puncture guide wire channel; an imaging core having a transmission surface arranged radially towards itself, the imaging core is arranged in the core channel; a catheter withdrawal part comprising a connecting tube and a withdrawal inner tube, the connecting tube is fixedly arranged at the proximal end of the catheter main body, and the withdrawal inner tube is sleeved on the proximal end of the imaging core and can move synchronously with the imaging core.

[0008] In an exemplary embodiment, the catheter retraction unit comprises a retraction outer tube sleeved outside the retraction inner tube, the retraction inner tube being movable relative to the retraction outer tube; the proximal end of the connecting tube comprises a flared groove formed by a flared wall, the flared groove being disposed around the distal end of the retraction outer tube, the connecting tube being rotatable relative to the retraction outer tube; the ultrasonic catheter further comprises a locking assembly, at least part of the structure of the locking assembly being occluded proximally connected to the flared groove, the locking assembly being limited with a movement space between the flared wall, the distal end of the retraction outer tube having only rotational freedom around its own axis in the movement space.

[0009] In an exemplary embodiment, the distal end of the retraction outer tube is rotatably inserted with the flared wall through a first retaining ring; the locking assembly comprises a damping sealing ring, the damping sealing ring being disposed on the side of the first retaining ring facing the proximal end, and the damping sealing ring being circumferentially filled between the flared wall and the retraction outer tube.

[0010] In an exemplary embodiment, the locking assembly further comprises a sealing sleeve, at least partially sleeved between the flared wall and the retraction outer tube, the sealing sleeve being fixedly connected with the connecting tube; the sealing sleeve and the first retaining ring are clamped on the axially opposite sides of the damping sealing ring.

[0011] In an exemplary embodiment, the flared wall has a stepped surface, the locking assembly further comprises a sliding gasket built into the stepped surface, the sliding gasket being clamped together with the damping sealing ring on the axially opposite sides of the first retaining ring.

[0012] In an exemplary embodiment, the catheter retraction unit further comprises a delivery tube, the distal end of the delivery tube penetrating the retraction outer tube and being connected to the core passage, the imaging core extending into the core passage through the delivery tube; the retraction inner tube is clamped between the retraction outer tube and the delivery tube, the gap between the retraction outer tube and the delivery tube providing guidance for the movement of the retraction inner tube.

[0013] In an exemplary embodiment, the catheter main body comprises: a sound-transmitting window comprising a side-by-side connected guide wire tube and core tube, the guide wire lumen of the guide wire tube serving as a partial tube segment of the puncture guide wire passage, the core lumen of the core tube serving as a partial tube segment of the core passage; the sound-transmitting window projects axially as an 8-shaped structure, the recess of the 8-shaped structure being adjacent to the junction of the guide wire tube and the core tube; the puncture guide wire outlet is opened on the side of the guide wire tube facing away from the core tube.

[0014] In one exemplary embodiment, the catheter body includes: a guidewire exchange section connected to the distal end of the acoustic window; the guidewire exchange section has a guidewire channel; the guidewire cavity and the core cavity are integrally offset from the guidewire channel in the axial direction; the axial projection of the guidewire exchange section at least partially overlaps with the axial projection of the acoustic window; and the axial projection of the proximal port of the guidewire channel at least partially overlaps with the axial projection of the recess.

[0015] In one exemplary embodiment, the catheter body includes: a guidewire exchange section connected to the distal end of the acoustic window, the guidewire exchange section having a guidewire channel, the proximal end of the guidewire exchange section having a transition section for connecting the acoustic window, and the cross-sectional dimensions gradually increasing from the guidewire exchange section to the acoustic window.

[0016] Another aspect of the present invention provides an ultrasound device, including a catheter control unit and an ultrasound catheter as described above. The catheter control unit is provided with a slot for mounting the catheter retraction section, and the retraction unit of the catheter control unit drives the imaging core to rotate and / or move within the core channel.

[0017] The ultrasound catheter provided by this invention includes: a catheter body having a guidewire channel, a puncture guidewire channel, and a core channel that are parallel to each other and not coaxial; the guidewire channel is located at the distal end of the catheter body, and the puncture guidewire channel and the core channel are both located at the proximal end of the guidewire channel and are arranged side by side; the catheter body has a puncture guidewire outlet communicating with the puncture guidewire channel; an imaging core having a emitting surface arranged radially toward itself, and the imaging core is located within the core channel; and a catheter retraction section including a connecting tube and a retraction inner tube, the connecting tube being fixedly located at the proximal end of the catheter body, and the retraction inner tube being sleeved on the proximal end of the imaging core and moving synchronously with the imaging core.

[0018] The aforementioned ultrasound catheter has a guidewire channel, a puncture guidewire channel, and a core channel directly integrated into the catheter body. This allows for direct ultrasound image recognition and guidewire extension without the need for other catheters. Furthermore, this application designs the guidewire channel, puncture guidewire channel, and core channel as parallel and non-coaxial structures, which facilitates the establishment of guidewire pathways adapted to occluded vessel scenarios using the integrated catheter. The overall size is also small, making catheter rotation easy and preventing tissue damage during catheter rotation. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0020] Figure 1 A cross-sectional view of the distal portion of an ultrasonic catheter according to a specific embodiment of the present invention;

[0021] Figure 2 A structural diagram of the proximal portion of an ultrasonic catheter according to a specific embodiment of the present invention;

[0022] Figure 3 A cross-sectional view of the proximal portion of an ultrasonic catheter according to a specific embodiment of the present invention;

[0023] Figure 4 for Figure 3 Enlarged view of point A;

[0024] Figure 5 A cross-sectional view of a catheter connector according to a specific embodiment of the present invention;

[0025] Figure 6 This is a structural diagram of the imaging core provided in a specific embodiment of the present invention;

[0026] Figure 7 This is a structural diagram of the dual-lumen microcatheter provided in a specific embodiment of the present invention;

[0027] Figure 8 This is a structural diagram of the sound-permeable window provided in a specific embodiment of the present invention;

[0028] Figure 9 A first partial cross-sectional view of the acoustic window and guide wire exchange section provided in a specific embodiment of the present invention;

[0029] Figure 10 A second partial cross-sectional view of the acoustic window and guide wire exchange section in a specific embodiment of the present invention.

[0030] Figure 11 A first structural diagram of the acoustic window and guide wire exchange section provided in a specific embodiment of the present invention;

[0031] Figure 12 for Figure 11 AA section view;

[0032] Figure 13 for Figure 11 BB section view;

[0033] Figure 14This is a second structural diagram of the acoustic window and guide wire exchange section provided in a specific embodiment of the present invention;

[0034] Figure 15 This is a structural diagram of the ultrasonic device provided in a specific embodiment of the present invention.

[0035] Figure label:

[0036] Catheter body 1, guide wire channel 11, puncture guide wire channel 12, core channel 13, guide wire 14, puncture guide wire 15;

[0037] Connecting tube 2, flared groove 21, flared wall 22, stepped surface 23, first branch 24, second branch 25, merging branch 26, first core cavity 27, first guide wire cavity 28;

[0038] Dual-lumen microcatheter 3, second core lumen 31, second guidewire lumen 32;

[0039] 4. Acoustic window, 41. Guide wire tube, 42. Core tube, 43. Third core cavity, 44. Third guide wire cavity, 45. Recess, 46. Puncture guide wire outlet, 47. Water outlet.

[0040] Guidewire exchange section 5, guidewire outlet 51, transition section 52, TIP section 53, imaging ring 54;

[0041] Conveying pipe 61, retractable outer pipe 62, first retaining ring 621, retractable inner pipe 63, outer diameter flared structure 631, retractable connector 64, first sleeve 641, second sleeve 642.

[0042] Locking assembly 7, damping sealing ring 71, sealing sleeve 72, sliding washer 73;

[0043] 8. Conduit connector; 81. Check valve; 82.

[0044] Imaging core 9, transducer 91, transducer base 92, torque spring 93, core connector 94;

[0045] The catheter control unit 10, the retraction unit 101, and the fixing unit 102 are included. Detailed Implementation

[0046] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0047] To enable those skilled in the art to better understand the present invention, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. In the specific embodiments, the distal end refers to the part of the corresponding component that is farther from the operator, typically the end where the component enters the patient's body or surgical area. The proximal end is the part of the corresponding component that is closer to the operator, typically the end held or manipulated by the operator. For a single component, the end closer to the operator is the proximal end, and the end farther from the operator is the distal end. Furthermore, it should be noted that the connections mentioned in this application include both direct connections between systems, components, and parts, and indirect connections between systems, components, and parts via a medium. Those skilled in the art should not interpret this as a limitation but should adapt it according to specific needs; all such connections do not exceed the scope of protection of this application.

[0048] The core of this invention is to provide an ultrasonic catheter and an ultrasonic device including the ultrasonic catheter, wherein the ultrasonic catheter is easy to operate.

[0049] For a specific embodiment of the ultrasonic catheter provided by this invention, please refer to 1 to 2018. Figure 15 This includes the catheter body 1. For example... Figure 1 As shown, the catheter body 1 has parallel and non-coaxial guide wire channels 11, puncture guide wire channels 12, and core channels 13. The guide wire channel 11 is used to pass through the guide wire 14, the puncture guide wire channel 12 is used to pass through the puncture guide wire 15, and the core channel 13 is used to place the imaging core 9.

[0050] Specifically, such as Figure 1 and Figure 14 As shown, the guidewire channel 11 is located at the distal end of the catheter body 1. The puncture guidewire channel 12 and the core channel 13 are both located at the proximal end of the guidewire channel 11, and are arranged side-by-side. The catheter body 1 has a puncture guidewire outlet 46 communicating with the puncture guidewire channel 12, specifically located at the distal end of the puncture guidewire channel 12. The puncture guidewire 15 enters from the proximal end of the puncture guidewire channel 12 and can extend from the puncture guidewire outlet 46.

[0051] The ultrasound catheter also includes a catheter retraction section and an imaging core 9, with the catheter retraction section and the catheter body 1 arranged sequentially from proximal to distal. The imaging core 9 extends into the core channel 13 of the catheter body 1 via the catheter retraction section. The imaging core 9 has an emitting surface arranged radially towards itself, specifically located in the distal region where the imaging core 9 is inserted into the core channel 13. The imaging core is disposed within the core channel and can rotate and / or move relative to the core channel to perform circumferential scanning ultrasound imaging of the tissue area where the emitting surface is located.

[0052] Specifically, such as Figures 2 to 4As shown, the catheter retraction section is connected to the proximal end of the catheter body 1. The catheter retraction section includes a connecting tube 2 and a retraction inner tube 63. The connecting tube 2 is fixedly disposed at the proximal end of the catheter body 1. The imaging core 9 can sequentially extend into the retraction inner tube 63, the connecting tube 2, and the catheter body 1. The retraction inner tube 63 is sleeved on the proximal end of the imaging core 9 and can move synchronously with the imaging core 9.

[0053] Specifically, such as Figure 6 As shown, the imaging core 9 includes a core connector 94, a torque spring 93, a transducer base 92, and a transducer 91, all connected together. The transducer 91 emits ultrasonic pulses and receives reflected echoes, realizing the mutual conversion of electrical signals and acoustic energy. The transducer base 92 provides a stable mounting platform for the transducer 91. The torque spring 93 provides controllable rotational power to the transducer 91, enabling circular scanning. The core connector 94 connects to an external drive structure.

[0054] The aforementioned ultrasound catheter has a main body 1 directly equipped with a guidewire channel 11, a puncture guidewire channel 12, and a core channel 13. This allows for direct ultrasound image recognition and guidewire extension based on the integrated ultrasound catheter, eliminating the need for other catheters. Furthermore, this application designs the guidewire channel 11, puncture guidewire channel 12, and core channel 13 as parallel and non-coaxial structures. This facilitates the establishment of guidewire pathways suitable for occluded blood vessel scenarios using the integrated catheter. The overall size is also small, making catheter rotation easier and preventing tissue damage during catheter rotation.

[0055] To further facilitate the adjustment of the orientation of the guidewire exit 46 and align it with the target direction, in some embodiments, such as Figure 3 and Figure 4 As shown, the catheter retraction section also includes a retraction outer tube 62, and the connecting tube 2 can rotate relative to the retraction outer tube 62.

[0056] Specifically, such as Figure 4 As shown, the catheter retraction section includes a retraction outer tube 62 sleeved outside the retraction inner tube 63. The retraction inner tube 63 is axially movable relative to the retraction outer tube 62. The proximal end of the connecting tube 2 includes a flared groove 21 formed by a flared wall 22. The flared groove 21 is disposed around the proximal end of the core channel 13 and around the distal end of the retraction outer tube 62. Specifically, the distal end of the retraction outer tube 62 extends into the flared groove 21.

[0057] In actual use, the retractable outer tube 62 is fixed to the fixing unit 102 of the catheter control unit 10 (CCU); the imaging core 9 extends into the retractable inner tube 63 and extends into the core channel 13 through the retractable inner tube 63 or the delivery tube 61 and connecting tube 2 inside the retractable inner tube 63. The imaging core 9 can move in the core channel 13 under the drive of the retractable unit 101 of the catheter control unit 10.

[0058] Because the retraction outer tube 62 and the catheter body 1 can rotate relative to each other, when the operator needs to adjust the orientation of the puncture guidewire outlet 46, they only need to use one hand to hold the retraction outer tube 62 and the other hand to rotate the catheter body 1 around the retraction outer tube 62, without having to remove the catheter body 1 from the fixing unit 102 of the catheter control unit 10 and then rotate the entire ultrasound catheter, making the operation convenient. In addition, after the puncture guidewire outlet 46 has been aligned with the target direction and the rotation of the catheter body 1 has stopped, the locking angle can be locked by the self-locking structure between the catheter body 1 and the retraction outer tube 62, or by other external limiting structures.

[0059] In some embodiments, to limit the retraction of the outer tube 62 and the catheter body 1, such as... Figure 4 As shown, the ultrasonic catheter also includes a locking assembly 7, at least a portion of which is connected to the proximal end of the flared groove 21 to prevent the retractable outer tube 62 from axially dislodging from the flared groove 21. A space is restricted between the locking assembly 7 and the flared wall 22, allowing the distal end of the retractable outer tube 62 only rotational freedom about its own axis within this space. That is, the retractable outer tube 62 can only rotate relative to the connecting tube 2, i.e., indirectly relative to the catheter body 1, and cannot move axially, thus preventing the retractable outer tube 62 from axially dislodging from the flared groove 21.

[0060] In some embodiments, the locking component 7, in addition to its limiting function, can also be used to achieve self-locking of the angle between the retractable outer tube 62 and the connecting tube 2. In this case, within the ultrasound catheter, the decoupled catheter body 1 and the retractable outer tube 62 of the catheter retraction section facilitate control of the puncture direction of the guidewire 15. This allows for adjustment of the orientation of the guidewire outlet 46 at the distal end of the ultrasound catheter by simply rotating the catheter body 1 and the connecting tube 2 without separating the ultrasound catheter and the catheter control unit 10. The entire process can be completed under real-time IVUS (Intravascular Ultrasound) guidance. Furthermore, the locking component 7 can directly lock the angular relationship between the catheter body 1, the connecting tube 2, and the retractable outer tube 62 after adjustment, significantly shortening the surgical time and improving the safety and accuracy of the procedure.

[0061] Optionally, such as Figure 4As shown, the retractable outer tube 62 is rotatably inserted into the flared wall 22 of the flared groove 21 via a first retaining ring 621. The locking assembly 7 includes a damping sealing ring 71 disposed in the flared groove 21. The damping sealing ring 71 is axially disposed on the side of the first retaining ring 621 facing the proximal end, and the damping sealing ring 71 circumferentially fills the space between the flared wall 22 and the retractable outer tube 62.

[0062] At this time, the damping sealing ring 71 axially compresses the first retaining ring 621, and the first frictional force between the sealing ring 71 and the first retaining ring 621 can serve as a damping force. When a torsional force greater than the first frictional force is provided to the conduit body 1 or the connecting pipe 2, the conduit body 1 or the connecting pipe 2 can be rotated. After rotation to the correct position, the relative angle between the retractable outer pipe 62 and the connecting pipe 2 can be automatically locked directly by means of the first frictional force. The angle self-locking of the connecting pipe 2 and the retractable outer pipe 62 is achieved directly by using the first frictional force provided by the damping sealing ring 71. The structure is simple and can achieve self-locking at any relative angle. In addition, the damping sealing ring 71 can also form a seal between the flared wall 22 and the retractable outer pipe 62, which has multiple functions. Of course, in other embodiments, the locking component 7 includes a ring of first teeth for fixing the connecting pipe 2, and a ring of second teeth can be provided on the retractable outer pipe 62. The first teeth and the second teeth achieve angle self-locking of the connecting pipe 2 and the retractable outer pipe 62 through interlocking.

[0063] Optionally, the retractable outer tube 62 and the first retaining ring 621 are integrally formed. For example... Figure 4 As shown, the distal end of the retractable outer tube 62 is turned outward to form a protruding structure, which serves as the first retaining ring 621. In addition, the first retaining ring 621 is an annular structure. Optionally, the two end faces of the first retaining ring 621 in the axial direction of the retractable outer tube 62 can be perpendicular to the axial direction of the retractable outer tube 62.

[0064] Alternatively, the damping seal 71 can be made of materials such as rubber, silicone, or TPU that can provide friction and sealing.

[0065] In some embodiments, such as Figure 4 As shown, the locking assembly 7 also includes a sealing sleeve 72, which can prevent the first retaining ring 621 from axially dislodging and seal between the retractable outer tube 62 and the flared wall 22.

[0066] Specifically, the sealing sleeve 72 is at least partially fitted between the flared wall 22 and the retractable outer tube 62. The sealing sleeve 72 is fixedly connected to the connecting tube 2. The distal end face of the sealing sleeve 72 mates with the proximal end of the first retaining ring 621, clamping it on opposite axial sides of the damping sealing ring 71. At this time, the sealing sleeve 72 can provide axial clamping force to the damping sealing ring 71, so that the damping sealing ring 71 is axially pressed against the first retaining ring 621; in addition, the sealing sleeve 72 connects the retractable outer tube 62 and the connecting tube 2 together, so that the two can only rotate relative to each other and cannot move axially relative to each other, and assembly is convenient.

[0067] Optionally, the sealing sleeve 72 can be a sealing cone, whose outer circumferential surface gradually decreases in radial dimension from the proximal end to the distal end, so that the sealing sleeve 72 has a certain taper, which can more easily be inserted into the radial gap between the flared wall 22 and the retractable outer tube 62.

[0068] Optionally, the sealing sleeve 72 is fixedly connected to the flared wall 22, for example, by bonding them together with adhesive, which ensures a sealing effect while connecting them.

[0069] Optionally, the proximal end of the sealing sleeve 72 has an outwardly flared annular end plate that is placed outside the flared wall 22 and abuts against the proximal end face of the flared wall 22 in an axial direction to limit the maximum distance that the sealing sleeve 72 can extend into the flared groove 21.

[0070] In some embodiments, to facilitate the rotation of the catheter body 1 and the connecting tube 2, such as Figure 4 As shown, the flared wall 22 has a stepped surface 23, and the locking assembly 7 also includes a sliding pad 73 built into the stepped surface 23 for lubrication. The sliding pad 73 and the damping sealing ring 71 are clamped on opposite sides of the first retaining ring 621 in the axial direction.

[0071] At this time, the two axial end faces of the first retaining ring 621 are respectively engaged with the sliding washer 73 and the damping sealing ring 71. Self-locking is achieved by damping provided only by the damping sealing ring 71 at the proximal end of the first retaining ring 621, while the distal end of the first retaining ring 621 is in sliding engagement with the sliding washer 73, which can improve the smoothness of the rotation of the retractable outer tube 62.

[0072] Optionally, the material of the sliding pad 73 can be PTFE, PEEK, POM, etc.

[0073] Optionally, the stepped surface 23 includes a first surface perpendicular to the axial direction facing the proximal end and an annular second surface arranged around the axis of the flared groove 21. The distal end face of the sliding pad 73 is axially fitted with the first surface, and the outer peripheral surface is radially fitted with the second surface.

[0074] During assembly, the sealing sleeve 72 sequentially presses the damping sealing ring 71, the first retaining ring 621, and the sliding washer 73 axially against the far end face of the flared groove 21, i.e., the first face. Figure 4 This is a time-lapse diagram showing the process before and during the clamping process. During the clamping process, the damping seal ring 71 expands radially, completely filling the gap between the flared wall 22 and the outer wall of the retractable outer tube 62 to isolate external air and internal liquid.

[0075] In some embodiments, to improve the stability of the axial movement of the imaging core 9, such as... Figure 4As shown, the catheter retraction section also includes a delivery tube 61, the distal end of which passes through the retraction outer tube 62 and connects to the core channel 13. A retraction inner tube 63 is sandwiched between the retraction outer tube 62 and the delivery tube 61. The gap between the retraction outer tube 62 and the delivery tube 61 provides guidance for the movement of the retraction inner tube 63. Since both the imaging core 9 and the retraction inner tube move under the drive of the retraction unit 101 of the catheter control unit 10, the guiding nature of the movement of the retraction inner tube 63 has a directional limiting effect on the movement of the imaging core 9.

[0076] Specifically, the proximal end of the retraction inner tube 63 may include a proximal structure extending from the delivery tube 61, or may be connected to other proximal structures, such as connecting to the conduit connector 8, and directly connecting the proximal structure to the retraction unit 101, thereby achieving axial synchronous movement of the retraction inner tube 63 and the imaging core.

[0077] Optionally, such as Figure 2 As shown, the delivery tube 61 is located at the proximal end of the core channel 13 and connected to the inner wall of the core channel 13. The imaging core 9 extends into the core channel 13 via the delivery tube 61. Exemplarily, the distal end of the delivery tube 61 extends into the core channel 13 via the flared groove 21 and is sealed to the core channel 13, and the delivery tube 61 and the connecting tube 2 are fixedly connected, for example, by adhesive.

[0078] Optionally, such as Figure 5 and Figure 4 As shown, the ultrasound catheter also includes a catheter connector 8, which includes a one-way valve 81 and an interface 82. The interface 82 is connected to the sheath connector, and the one-way valve 81 provides a one-way water passage for the operator to use a syringe to inject water to expel air from the lumen. In application, the distal end of the interface 82 is connected to the retraction inner tube 63. The imaging core 9 passes sequentially through the interface 82, the delivery tube 61, and the core channel 13 to reach the initial imaging position at the distal end of the ultrasound catheter. The interface 82 is connected to the retraction unit 101 of the catheter control unit 10, so that the retraction unit 101 can drive the catheter connector 8 and the imaging core 9 to perform axial forward and backward movements and rotation.

[0079] Optionally, such as Figure 15 and Figure 4As shown, the catheter retraction section also includes a retraction connector 64. The retraction connector 64 can be made of a material with a hardness greater than that of the retraction outer tube 62 to facilitate a reliable connection with the fixing unit 102 of the catheter control unit 10. Specifically, the retraction connector 64 includes a first sleeve 641 and a second sleeve 642 fixedly connected to each other. The first sleeve 641 is fixedly connected to the retraction outer tube 62, and the second sleeve 642 has a different radial dimension from the first sleeve 641 to achieve a stepped connection. In application, the first sleeve 641 or the second sleeve 642 of the retraction connector 64 can be used to fix to the fixing unit 102 of the catheter control unit 10, for example, by snap-fit ​​fixation, thereby indirectly achieving the fixation between the retraction outer tube 62 and the fixing unit 102.

[0080] Optionally, such as Figure 1 As shown, the distal end of the retractable inner tube 63 is an outer diameter flared structure 631, at least a portion of which is located on the outer side of the inner wall of the retractable connector 64 in the radial direction. Thus, when the retractable inner tube 63 moves outward relative to the retractable outer tube 62 in the axial direction, the radial dimension of the second sleeve 642 is further set to be smaller than that of the first sleeve 641 or the inner cavity of the second sleeve 642 is smaller than that of the first sleeve 641. Thus, when the retractable inner tube 63 moves, its outer diameter flared structure 631 can move relative to the retractable connector 64 until the retractable inner tube 63 can move to abut against the second sleeve 642 of the retractable connector 64, thereby ensuring that the retractable inner tube 63 will not slide completely out of the retractable connector 64 in the axial direction.

[0081] In some embodiments, such as Figure 2 and Figures 2 to 4 As shown, the catheter body 1 includes a double-lumen microcatheter 3, an acoustic window 4, and a guidewire exchange section 5, which are arranged and connected sequentially from the proximal end to the distal end.

[0082] The proximal structure of the catheter body 1 is a double-lumen microcatheter 3, which is connected to a connecting tube 2. Exemplarily, the connecting tube 2 is a Y-shaped connecting tube, such as... Figure 1 As shown, the Y-shaped connecting pipe includes a first branch 24, a second branch 25, and a merging branch 26. Each of the first branch 24, second branch 25, and merging branch 26 has a channel. The distal ends of the first branch 24 and the second branch 25 are connected to the proximal end of the merging branch 26, and a flared groove 21 is provided at the proximal end of the first branch 24. The flared groove 21 at the proximal end of the first branch 24 is used to connect the retraction outer pipe 62 and the sealing sleeve 72.

[0083] Among them, reference Figure 2 and Figure 7The channels of the first branch 24 and the merging branch 26 are connected to form the first core cavity 27, and the distal end of the first core cavity 27 is connected to the proximal end of the core channel 13; the channels of the second branch 25 and the merging branch 26 are connected to form the first guidewire cavity 28, and the distal end of the first guidewire cavity 28 is connected to the proximal end of the puncture guidewire channel 12. Thus, through the Y-shaped connecting tube 2, the tubing connecting the proximal end of the puncture guidewire channel 12 and the core channel 13 can be integrated into one unit, which can reduce the space occupied by the equipment.

[0084] In the double-lumen microcatheter 3, as Figure 8 As shown, it has two channels: a second core cavity tube 31 that connects proximally to the first core cavity 27, and a second guidewire cavity 32 that connects proximally to the first guidewire cavity 28. The second core cavity tube 31 forms part of the core channel 13, and the second guidewire cavity 32 forms part of the puncture guidewire channel 12.

[0085] Optionally, the dual-lumen microcatheter 3, except for a small section (e.g., 10-20 mm in length) at its proximal and distal ends, is provided with a metal braided mesh middle layer throughout, giving the tube body near 1:1 torque control.

[0086] Optionally, the inner walls of the second core cavity 31 and the second guide wire cavity 32 are made of a low coefficient of friction material, such as HDPE, PTFE, PI, etc.

[0087] In sound transmission window 4, such as Figure 8 As shown, the acoustic window 4 includes a guide wire tube 41 and a core tube 42 connected side by side. The guide wire tube 41 has a third guide wire cavity 44, which is a part of the guide wire puncture channel 12; the core tube 42 has a third core cavity 43, which is a part of the core channel 13.

[0088] At this time, the core channel 13 includes a second core cavity tube 31 and a third core cavity 43 arranged and connected from the proximal end to the distal end. The proximal end of the second core cavity tube 31 is connected to the distal end of the first core cavity 27. The imaging core 9 passes through the interface 82, the delivery tube 61, the first core cavity 27 of the connecting tube 2, the second core cavity tube 31 of the dual-lumen microcatheter 3, and the third core cavity 43 of the acoustic window 4 to reach the initial imaging position at the distal end of the catheter. The puncture guidewire channel 12 includes a second guidewire cavity 32 and a third guidewire cavity 44 arranged and connected from the proximal end to the distal end. The proximal end of the second guidewire cavity 32 is connected to the distal end of the first guidewire cavity 28. At this time, the puncture guidewire 15 passes through the first guidewire cavity 28, the second guidewire cavity 32 and the third guidewire cavity 44 and exits from the puncture guidewire outlet 46.

[0089] In addition, such as Figure 9 and Figures 9 to 14As shown, the acoustic window 4 has an axial projection that resembles an "8," with the recess 45 of the "8" structure adjacent to the connection point a between the guidewire tube 41 and the core tube 42. The puncture guidewire outlet 46 is located on the side of the guidewire tube 41 facing away from the core tube 42, and the outlet 47 is located on the side of the core tube 42 facing away from the guidewire tube 41. The acoustic window 4 adopts an "8" shaped tube structure, which, compared to other tube shapes, allows for less obstruction of the ultrasound field of view and a smaller catheter profile.

[0090] Optionally, the sound-permeable window 4 can be made of a material that is easy to process and mold and has good sound transmission effect, such as PE, PA, PEBAX, etc.

[0091] In the guidewire exchange section 5, such as Figure 12 As shown, the guide wire exchange section 5 has a guide wire channel 11. The third guide wire cavity 44 and the third core cavity 43 are axially offset from the guide wire channel 11. That is, the axial parallel projection of the guide wire channel 11 does not completely coincide with the axial parallel projection of the third guide wire cavity 44 and the third core cavity 43 on the same plane. They may partially coincide or be completely offset. In addition, unless otherwise specified, the projection in this embodiment refers to the parallel projection.

[0092] For example, such as Figure 11 As shown, the axial projection of the guidewire exchange section 5 at least partially overlaps with the axial projection of the acoustic window 4, which helps to reduce the overall contour of the three cavities, allowing the distal end of the ultrasound catheter to pass through more tortuous and narrow blood vessels without easily causing problems such as tube kinking. More specifically, the guidewire exchange section 5, guidewire tube 41, and core tube 42 can be arranged in a triangular pattern, that is, the axial projections of the centerlines of the guidewire exchange section 5, guidewire tube 41, and core tube 42 on the same plane are located at the three vertices of a triangle. The triangular support structure has good stability, thus ensuring structural stability in addition to reducing size.

[0093] Optionally, such as Figure 11 As shown, the axial projection of the proximal port of the guidewire channel 11 at least partially overlaps with the axial projection of the recess 45, and the proximal port of the guidewire channel 11 is the guidewire outlet 51. In this case, besides reducing the size of the distal structure of the ultrasound catheter, when the guidewire 14 in the guidewire channel 11 passes through the guidewire outlet 51, it can roughly conform to the position of the recess 45 and continuously move axially out of the guidewire outlet 51, thus providing a guiding function. Furthermore, the third guidewire cavity 44 in the acoustic window 4 and the guidewire channel 11 of the guidewire exchange section 5 are perpendicularly distributed at 90° relative to each other axially, facilitating real-time judgment of the relative positions of the ultrasound artifacts of the guidewire 14 and the puncture guidewire 15 by the ultrasound element in the imaging core 9 of the acoustic window 4, making it easier for the operator to determine the puncture direction.

[0094] Optionally, such as Figures 9 to 11As shown, the proximal part of the guidewire exchange section 5 can be embedded and fused into the distal end of the recess 45 of the acoustic window 4, which can not only effectively improve the support and stability of the distal end of the ultrasound catheter, but also effectively reduce the maximum profile of the distal end of the ultrasound catheter, allowing the device to pass through the vascular lesion better.

[0095] Optionally, such as Figure 10 As shown, the proximal end of the guidewire exchange section 5 has a transition section 52, which connects the guidewire exchange section 5 to the acoustic window 4. The cross-sectional dimensions of the transition section 52 gradually increase from the guidewire exchange section 5 to the acoustic window 4, and the cross-section is perpendicular to the axial direction. This gradual connection not only reduces the size but also accommodates the cross-sectional differences between the guidewire exchange section 5 and the acoustic window 4, avoiding abrupt changes in cross-section, reducing the risk of stress concentration, ensuring the smoothness of the ultrasonic catheter surface, and guaranteeing the mechanical transmission performance at the connection point.

[0096] Optionally, such as Figure 15 As shown, the guidewire exchange section 5 is further fitted with a TIP segment 5332 and a contrast ring 5433 on its outer side. The TIP segment 53 is a structure on the ultrasound catheter that directly contacts the tissue, enabling soft contact and avoiding damage to the intima. The contrast ring 54 can be visualized using X-ray equipment in the context of ultrasound interventional surgery to mark the distal position of the ultrasound catheter.

[0097] In addition to the aforementioned ultrasonic catheter, the present invention also provides an ultrasonic device, which includes an ultrasonic catheter. Specifically, the ultrasonic catheter can be the ultrasonic catheter provided in any of the above embodiments, and the beneficial effects can be referred to the above embodiments accordingly.

[0098] like ​ As shown, the ultrasound device also includes a catheter control unit 10, which includes a retraction unit 101 and a fixing unit 102. The retraction unit drives the imaging core 9 to rotate and / or move within the core channel 13 and the connecting tube 2. The fixing unit 102 includes a slot for mounting the catheter retraction section, specifically engaging the retraction connector 64 (specifically, engaging the first sleeve 641) and / or the retraction outer tube 62.

[0099] It should be noted that, in one specific embodiment, the retraction unit 101 may include a first drive unit (not shown) for independently driving the rotation of the imaging core 9 and a second drive unit (not shown) for independently driving the movement of the imaging core 9. The first drive unit may be mounted on the second drive unit, and the first drive unit is directly connected to the imaging core. The second drive unit is connected to the retraction inner tube 63. When the first drive unit and the second drive unit work simultaneously, since the first drive unit is arranged on the second drive unit, it drives the imaging core 9 to rotate while moving axially. Since the second drive unit is connected to the retraction inner tube 63, the retraction inner tube 63 guides the movement of the imaging core 9. The abutment between the retraction inner tube 63 and the retraction connector 64 limits the retraction stroke of the axial movement to a retraction termination position.

[0100] In application, the retraction unit 101 connects to the interface 82 of the catheter connector 8, driving the imaging core 9 in the interface 82 to move forward and backward or rotate axially. The slot connects to the retraction connector 64, thereby fixing the retraction outer tube 62 and the retraction connector 64 of the catheter retraction part to the slot. When the operator needs to adjust the orientation of the puncture guidewire outlet 46, only one hand needs to hold the retraction outer tube 62, and the other hand needs to rotate the connecting tube 2, without having to remove the ultrasound catheter from the slot and rotate the entire catheter body. When the ultrasound image determines that the puncture guidewire outlet 46 is aligned with the target direction, after stopping the rotation, the catheter body 1 of the ultrasound catheter can self-lock in the current position under the combined action of the sliding pad 73 and the damping sealing ring 71, locking the angular relationship with the retraction outer tube 62, thereby locking the orientation of the puncture guidewire outlet 46, achieving faster and more precise control.

[0101] It should be noted that when an element is referred to as "fixing" another element, it can be directly attached to the other element or there may be an intervening element. When an element is referred to as "connecting" another element, it can be directly connected to the other element or there may be an intervening element. Furthermore, in the description of this invention, unless otherwise stated, "multiple," "multiple roots," and "multiple groups" mean two or more.

[0102] The terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the invention. Furthermore, the terms "second," "third," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated.

[0103] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0104] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0105] The ultrasonic catheter and ultrasonic device provided by this invention have been described in detail above. Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the embodiments above are only for the purpose of helping to understand the method and core ideas of this invention. It should be noted that those skilled in the art can make various improvements and modifications to this invention without departing from its principles, and these improvements and modifications also fall within the protection scope of the claims of this invention.

Claims

1. An ultrasonic catheter, characterized by, The catheter comprises: a catheter body having a guide wire channel, a puncture wire channel and a core channel which are parallel to each other and not coaxial, the guide wire channel is arranged at the distal end of the catheter body, the puncture wire channel and the core channel are arranged at the proximal end of the guide wire channel and are arranged side by side, and the catheter body is provided with a puncture wire outlet which is in communication with the puncture wire channel; an imaging core having a transmission surface arranged radially towards itself, the imaging core is arranged in the core channel and can rotate and / or move relative to the core channel; a catheter retraction part comprising a connecting tube and a retraction inner tube, the connecting tube is fixedly arranged at the proximal end of the catheter body, and the retraction inner tube is sleeved on the proximal end of the imaging core and can move synchronously with the imaging core.

2. The ultrasonic catheter of claim 1, wherein, The catheter retraction part comprises a retraction outer tube which is sleeved on the retraction inner tube, and the retraction inner tube can move relative to the retraction outer tube; The proximal end of the connecting tube comprises a flared groove which is formed by a flared wall, the flared groove is arranged around the distal end of the retraction outer tube, and the connecting tube can rotate relative to the retraction outer tube; The ultrasonic catheter further comprises a locking assembly, at least part of the structure of the locking assembly is blocked and connected to the proximal end of the flared groove, the locking assembly is limited with a movement space between the flared wall, and the distal end of the retraction outer tube only has a rotation freedom degree around its own axis in the movement space.

3. The ultrasonic catheter of claim 2, wherein, The distal end of the retraction outer tube is rotatably inserted with the flared wall by arranging a first retainer ring; The locking assembly comprises a damping sealing ring, the damping sealing ring is arranged on the side of the first retainer ring which is towards the proximal end, and the damping sealing ring is circumferentially filled between the flared wall and the retraction outer tube.

4. The ultrasonic catheter of claim 3, wherein, The locking assembly further comprises a sealing sleeve which is at least partially sleeved between the flared wall and the retraction outer tube, and the sealing sleeve is fixedly connected with the connecting tube; The sealing sleeve and the first retainer ring are clamped on the axially opposite sides of the damping sealing ring.

5. The ultrasonic catheter of claim 3, wherein, The flared wall has a stepped surface, the locking assembly further comprises a sliding gasket which is built in the stepped surface, and the sliding gasket and the damping sealing ring are jointly clamped on the axially opposite sides of the first retainer ring.

6. The ultrasonic catheter of claim 2, wherein, The catheter retraction part further comprises a delivery tube, the distal end of the delivery tube penetrates through the retraction outer tube and is connected to the core channel, and the imaging core extends into the core channel through the delivery tube; The retraction inner tube is clamped between the retraction outer tube and the delivery tube, and the gap between the retraction outer tube and the delivery tube provides a guide for the movement of the retraction inner tube.

7. The ultrasonic catheter of any of claims 1 to 6, wherein, The catheter body comprises: an acoustic window comprising a guide wire tube and a core tube which are connected side by side, the guide wire cavity of the guide wire tube is part of the puncture wire channel, and the core cavity of the core tube is part of the core channel; the acoustic window is projected in the axial direction to form an 8-shaped structure, and the recess of the 8-shaped structure is adjacent to the connection between the guide wire tube and the core tube; The puncture wire outlet is arranged on the side of the guide wire tube which is away from the core tube.

8. The ultrasonic catheter of claim 7, wherein, The catheter body comprises: A guide wire exchange portion connected to a distal end of the acoustic window, the guide wire exchange portion having the guide wire passage, The guide wire lumen and the core lumen are both axially offset from the guide wire passage, a projection of the guide wire exchange portion along an axial direction at least partially overlaps a projection of the acoustic window along the axial direction, and a projection of a proximal end port of the guide wire passage along the axial direction at least partially overlaps a projection of the recess along the axial direction.

9. The ultrasonic catheter of claim 7, wherein, The catheter body comprises: A guide wire exchange portion connected to a distal end of the acoustic window, the guide wire exchange portion having the guide wire passage, A proximal end of the guide wire exchange portion has a transition section for connecting the acoustic window, a cross-sectional size gradually increases from the guide wire exchange portion to the acoustic window.

10. An ultrasound apparatus, characterized by A catheter control unit and an ultrasonic catheter as claimed in any one of claims 1 to 9, the catheter control unit being provided with a clamping groove for mounting the catheter withdrawal portion, a withdrawal unit of the catheter control unit driving the imaging core to rotate and / or move in the core passage.

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