Butt joint assembly and catheter system

Abstract

The invention relates to a butt joint assembly and a catheter system. The catheter system comprises a catheter assembly and a butt joint assembly. The guide pipe assembly comprises an outer sleeve, a bending control pipe and a torque pipe which are sequentially arranged from outside to inside. The butt joint assembly comprises a butt joint cap and a rotating base. The rotary base is fixed at the far end of the bending control pipe; the butt joint cap is fixed at the far end of the torque tube; the rotary base is at least partially inserted into the butt joint cap; an annular groove is formed in the outer side of the rotating base; at least one protruding part is arranged on the inner side of the butt joint cap. The protruding part is embedded into the annular groove, is matched with the annular groove, is connected with the butt joint cap and the rotating base, limits the relative movement of the butt joint cap and the rotating base, and allows the relative rotation of the butt joint cap and the rotating base. Through the configuration, on the premise of meeting the use requirements, the structure is simplified, the overall size is reduced, and the operation flexibility and accuracy of the catheter system are improved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a docking assembly and a catheter system for delivering or retrieving a biostimulator. Background Art

[0002] A cardiac pacemaker is an advanced medical device whose main function is to precisely adjust the beating frequency and rhythm of the heart by sending electrical signals to the heart. Specifically, the cardiac pacemaker can monitor the beating condition of the heart. Once it detects that the beating is too slow, too fast or irregular, it will automatically send electrical signals for intervention to restore the heart to a normal beating state. This can not only improve the heart's pumping ability, improve blood circulation, but also effectively relieve symptoms caused by arrhythmia, such as syncope, palpitations, fatigue and shortness of breath, thereby significantly improving the patient's quality of life and preventing serious complications caused by arrhythmia, such as heart failure, myocardial infarction and sudden death.

[0003] Traditional pacemakers need to be connected to the heart through wires, and these wires may cause some complications, such as wire abrasion, fracture, dislocation, and rupture and infection of the pacemaker pocket. In addition, the implantation process of traditional pacemakers is relatively complex, and it is necessary to cut the skin on the body surface and make a pocket to place the pulse generator, which may bring certain pain and inconvenience to the patient. A leadless pacemaker is a miniature medical device that combines a pulse generator and a pacing electrode into one body, and it can be directly implanted into the patient's heart cavity without wire connection. This innovative design enables the pacemaker to avoid wire-related complications and overcome the limitations of traditional pacemakers, making the implantation process simpler and safer. A leadless pacemaker needs to be implanted into or retrieved from the heart through a dedicated delivery and retrieval system. Leadless pacemakers are divided into active fixation and passive fixation according to different fixation methods. Among them, the fixation device of active fixation is a helical spring with a needle tip, similar to a corkscrew inserted into a wine bottle cork. The delivery system needs to apply torque to the pacemaker to rotate it along the central axis, so as to fix it on the endocardium of the heart.

[0004] The delivery system of a leadless pacemaker needs to achieve distal deflection and distal rotation functions, usually requiring two different catheters for control; one is a bending control catheter with a deflection mechanism that can control the bending angle of the distal end to pass through curved blood vessels or the heart; the other is a torsion catheter with a torque transmission function that controls the rotation of the implant through a docking cap at the distal end. The torsion catheter is located inside the bending control catheter, and the distal end of the torsion catheter extends out of the bending control catheter and is connected to the docking cap. Therefore, during the deflection of the bending control catheter, the internal torsion catheter will also deflect accordingly, resulting in the deflection of the docking cap connected to the torsion catheter. If there is no axial displacement restriction on the docking cap at the farthest end of the torsion catheter, the docking cap will drive the leadless pacemaker to extend unexpectedly farther distally, causing the active fixation device to be exposed outside the safe range and causing unexpected damage to the heart or blood vessels. Therefore, how to restrict the axial displacement of the docking cap without affecting the functions of distal deflection and torque transmission is an important issue. Also, how to minimize the size of the docking cap and related structures is also an important consideration. However, existing products not only have complex structures but also large overall sizes and need to be improved.

[0005] It should be noted that the information disclosed in the background art section of the present invention is intended to deepen the understanding of the general background art of the present invention and should not be regarded as an admission or any form of suggestion that this information constitutes the prior art known to those skilled in the art. Summary of the Invention

[0006] The purpose of the present invention is to provide a docking assembly and a catheter system, aiming to simplify the structure of the docking cap part and reduce the overall size of the docking cap part on the premise of meeting the usage requirements.

[0007] To achieve the above purpose, the present invention provides a docking assembly, including a docking cap and a rotating base; at least part of the rotating base is inserted into the docking cap; a circular groove is provided on the outer side of the rotating base; at least one protruding part is provided on the inner side of the docking cap; the protruding part is embedded in the circular groove and cooperates with the circular groove to connect the docking cap and the rotating base, restrict the relative movement of the docking cap and the rotating base, and allow the relative rotation of the docking cap and the rotating base.

[0008] Optionally, one or more windows penetrating the interior are provided on the docking cap, and / or the outer shape of the docking cap is set to match the inner cavity of the distal end of the outer sheath.

[0009] Optionally, the docking assembly further includes a connecting shaft integrally formed with the docking cap, and the connecting shaft is provided as the protruding portion to be inserted into the annular groove; the connecting shaft is radially located between the docking cap and the rotary base, and both ends of the connecting shaft are fixedly connected to the docking cap.

[0010] Optionally, multiple connecting shafts are arranged circumferentially and uniformly around the central axis of the docking assembly, and / or, the docking cap is provided with mounting holes, and the mounting holes are through holes or blind holes. Both ends of the connecting shaft are inserted into a corresponding one of the mounting holes and fixedly connected, and the open end of the mounting hole is sealed with glue after the connecting shaft is inserted.

[0011] Optionally, the contact between the protruding portion and the annular groove is a line contact.

[0012] Optionally, the protruding portion has a convex arc surface, and the annular groove is provided as an arc groove.

[0013] Optionally, the docking assembly further includes a gasket for reducing multi-point frictional contact, and the gasket is radially located between the docking cap and the rotary base.

[0014] Optionally, the rotary base is partially inserted into the docking cap; the docking assembly extends axially a certain length from the end face of the nearest end to form a tapered section; the tapered section is divided into a first part and a second part; the first part extends axially from the proximal end face of the docking cap to the near side of the protruding portion; the second part extends axially from the proximal end face of the rotary base to the far side and terminates at a position corresponding to the proximal end face of the docking cap.

[0015] Optionally, the slope of the second part is gentler than that of the first part, and / or, a step is provided at the position on the rotary base corresponding to the proximal end face of the docking cap, and the proximal end of the docking cap abuts against the step.

[0016] To achieve the above object, the present invention further provides a catheter system, which includes: a catheter assembly and the docking assembly according to any one of the above; the catheter assembly includes an outer sleeve, a bending control tube and a torsion tube arranged in sequence from outside to inside; the rotary base is installed at the distal end of the bending control tube; the docking cap is installed at the distal end of the torsion tube.

[0017] Optionally, the outer sleeve has a thick diameter section, a diameter-changing section and a thin diameter section arranged in sequence from far to near along its own axis; the inner diameter of the thick diameter section is greater than the outer diameter of the docking assembly; the outer shape of the docking cap is set to be able to interfere with the inner cavity of the diameter-changing section.

[0018] Optionally, one or more windows that penetrate the interior are provided on the docking cap at positions corresponding to interference with the reduced-diameter section, and / or, the docking assembly extends axially distally from the end face of the proximal end by a certain length to form a tapered section, and the slope of the tapered section matches the slope of the reduced-diameter section.

[0019] Compared with the prior art, the docking assembly and the catheter system provided by the present invention have at least the following beneficial effects:

[0020] The aforementioned docking assembly includes a docking cap and a rotary base; at least a part of the rotary base is inserted into the docking cap; an annular groove is provided on the outer side of the rotary base; at least one protruding part is provided on the inner side of the docking cap; the protruding part is embedded in the annular groove and cooperates with the annular groove to connect the docking cap and the rotary base, limit the relative movement of the docking cap and the rotary base, and allow the relative rotation of the docking cap and the rotary base. When the docking assembly is connected to the catheter assembly to form a catheter system, the rotary base is installed at the distal end of the steering catheter, and the docking cap is installed at the distal end of the torque tube. With such a configuration, the present invention can achieve the interconnection of the docking cap and the rotary base through the connection method of the cooperation between the protruding part and the annular groove, limit the axial displacement of the docking cap, and thus can avoid the docking cap driving the biological stimulator to extend further distally during the steering deflection, causing unexpected damage to blood vessels or the heart, and also does not affect the torque transmission, enabling the docking cap to rotate on the rotary base, thereby driving the entire biological stimulator to rotate.

[0021] In addition, on the premise of meeting the use requirements, the technical solution of the present invention can replace complex connection methods such as traditional bearings, greatly simplify the overall structure of the docking assembly, simplify the process, reduce the cost, and also greatly reduce the overall size of the docking assembly. Since the docking assembly of the present invention has a smaller size compared with the same type of products, the turning radius of the entire catheter system in blood vessels and the heart is smaller, which can significantly improve the intraoperative operation flexibility and accuracy, reduce the surgical operation difficulty, and increase the surgical safety. Description of the Drawings

[0022] Those of ordinary skill in the art will understand that the provided drawings are used to better understand the present invention and do not constitute any limitation to the scope of the present invention. Among them:

[0023] Figure 1 is the front view of the leadless pacemaker;

[0024] Figure 2 is Figure 1 the right view of the leadless pacemaker in

[0025] Figure 3 is the structural schematic diagram of the catheter system provided according to the embodiment of the present invention;

[0026] Figure 4 Side view of the distal end of the torsion tube according to an embodiment of the present invention connected to the docking cap;

[0027] Figure 5 Front view of the distal end of the torsion tube according to an embodiment of the present invention connected to the docking cap;

[0028] Figure 6 Overall structural schematic diagram of the docking assembly according to an embodiment of the present invention, with the connecting shaft omitted in the illustration;

[0029] Figure 7 Axial sectional schematic diagram of the docking assembly obtained by omitting the connecting shaft according to an embodiment of the present invention;

[0030] Figure 8 Axial sectional schematic diagram of the docking assembly obtained with the connecting shaft according to an embodiment of the present invention;

[0031] Figure 9 Axial sectional schematic diagram of the docking assembly obtained with the connecting shaft and covered by the thick - diameter section of the outer sleeve according to an embodiment of the present invention;

[0032] Figure 10 Axial sectional schematic diagram of the docking assembly obtained by omitting the connecting shaft and covered by the thick - diameter section of the outer sleeve according to an embodiment of the present invention;

[0033] Figure 11 Proximal view of the docking cap according to an embodiment of the present invention;

[0034] Figure 12 Distal view of the docking cap according to an embodiment of the present invention;

[0035] Figure 13 Top view of the docking cap according to an embodiment of the present invention;

[0036] Figure 14 Front view of the docking cap corresponding to the window position according to an embodiment of the present invention;

[0037] Figure 15 Front view of the docking cap away from the window position according to an embodiment of the present invention;

[0038] Figure 16 Proximal view of the rotating base according to an embodiment of the present invention;

[0039] Figure 17 Distal view of the rotating base according to an embodiment of the present invention;

[0040] Figure 18The front view of the rotating base provided according to an embodiment of the present invention;

[0041] Figure 19 The schematic structural view of the rotating base provided according to an embodiment of the present invention in cooperation with two connecting shafts at the annular groove;

[0042] Figure 20 The schematic internal structural view of the docking cap provided according to an embodiment of the present invention;

[0043] Figure 21 The schematic structural view of the connecting shaft provided according to an embodiment of the present invention;

[0044] Figure 22 The schematic view of the usage state of the docking cap accommodating the connection features and proximal features of the biostimulator provided according to an embodiment of the present invention;

[0045] Figure 23 The schematic view of the usage state of the docking cap and the biostimulator being covered in the thick diameter section of the outer sleeve provided according to an embodiment of the present invention.

[0046] [Description of reference numerals]: 10 - leadless pacemaker, 10A - proximal feature, 11 - fixing device, 12 - distal electrode, 13 - electronic control compartment, 14 - battery compartment, 15 - connection feature, 100 - catheter assembly, 110 - outer sleeve, 111 - thick diameter section, 112 - thin diameter section, 113 - diameter-changing section, 120 - steering catheter, 130 - torque tube; 200 - docking assembly, 201 - tapered section, 210 - docking cap, 2101 - distal flange area, 2102 - intermediate area, 2103 - proximal connection area, 2104 - flared opening, 2105 - central hole, 2106 - partition, 2107 - positioning feature, 211 - protruding part, 212 - mounting hole, 213 - window, 220 - rotating base, 221 - proximal part, 222 - distal part, 223 - step, 220a - annular groove, 230 - connecting shaft. Detailed implementation manners

[0047] The following illustrates the implementation manners of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation manners. Various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in this embodiment only illustrate the basic concept of the present invention schematically. Therefore, only the components related to the present invention are shown in the drawings, rather than being drawn according to the number, shape, and size of the components in actual implementation. The type, quantity, and ratio of each component in actual implementation can be arbitrarily changed, and the component layout type may also be more complex.

[0048] In addition, each of the embodiments of the following description content has one or more technical features. However, this does not mean that the inventor must implement all the technical features in any one embodiment simultaneously, or can only separately implement some or all of the technical features in different embodiments. In other words, on the premise that implementation is possible, those skilled in the art can, according to the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all of the technical features in any one embodiment, or selectively implement the combination of some or all of the technical features in multiple embodiments, thereby increasing the flexibility when implementing the present invention.

[0049] As used in this specification, the singular forms "a", "an", and "the" include plural referents, and the plural form "plural" includes more than two referents, unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or", unless the context clearly indicates otherwise, and the terms "mounted", "connected", "coupled" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and can be the communication inside two elements or the interaction relationship between two elements. The relational terms such as "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor indicate or imply relative importance or implicitly specify the quantity of the indicated technical features. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. In addition, the terms "proximal", "proximal side" and "distal", "distal side" are defined herein relative to an operator such as a surgeon or a clinician. The terms "proximal" and "proximal side" refer to a position closer to the operator, and the terms "distal" and "distal side" refer to a position closer to the affected area and thus farther from the operator.

[0050] One of the objectives of the present invention is to provide a docking assembly, by which a biological stimulator and a catheter system can be detachably joined to deliver or retrieve the biological stimulator.

[0051] The docking assembly of the present invention not only axially restricts the displacement of the docking cap, but also does not affect the distal deflection and torque transmission. More importantly, compared with the traditional docking cap structure, the structure of the entire docking assembly is simple, greatly simplifies the process, reduces costs, and is also convenient for assembly. Especially on the premise of meeting the use requirements, the overall size is much smaller than that of the same type of products.

[0052] The second object of the present invention is to provide a catheter system provided with the docking assembly of the present invention. The catheter system of the present invention can not only deliver a biological stimulator but also retrieve the biological stimulator. Moreover, based on the improvement of the docking assembly of the present invention, the catheter system improves the operation flexibility and accuracy inside human blood vessels and the heart, reduces the surgical operation difficulty at the same time, and increases the surgical safety.

[0053] It is also worth noting that the application of the biological stimulator in the present invention is not restrictive. For example, it can be an implantable cardiac pacemaker, an implantable electrocardiogram detector, an implantable cardioverter defibrillator, a deep brain stimulator, a spinal cord stimulator, a vagus nerve stimulator, a sacral nerve stimulator, etc. It should also be noted that although the following description is made with a leadless pacemaker, this application should not constitute a limitation to the technical solution of the present invention.

[0054] To make the objects, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in a very simplified form and use non-precise scales, only for the purpose of facilitating and clearly assisting in explaining the objects of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0055] First, referring to Figure 1 and Figure 2 , in an exemplary application, the biological stimulator involved in the present invention is a leadless pacemaker 10, and the leadless pacemaker 10 needs to be implanted into the patient's heart. The implanted leadless pacemaker 10 can be single or multiple. And the leadless pacemaker 10 can be implanted into the right atrium and / or right ventricle through the catheter system (equivalent to the delivery system and / or retrieval system) of the present invention, or attached to the outside of the heart cavity, or the leadless pacemaker 10 can be taken out of the body. The attachment of the leadless pacemaker 10 to the heart tissue can be achieved through one or more fixing devices 11, such as screw fixation or other fixation forms.

[0056] In one embodiment, the leadless pacemaker 10 is an active fixation type, mainly including a fixation device 11, a distal electrode 12, an electronic control compartment 13, a battery compartment 14, and a connection feature 15. The fixation device 11 is located at the distal end of the leadless pacemaker 10 and may include a helical spring with a tip and a base for fixing the helical spring. It should be understood that one or more fixation devices 11 may be provided on the biostimulator. The leadless pacemaker 10 is fixed to the intended intracardiac implantation site, such as the myocardial septum of the right atrium or right ventricle, through the fixation device 11. In other cases, the fixation device 11 may be formed as part of the distal electrode 12. The leadless pacemaker 10 generally further includes a housing, on which the electronic control compartment 13 and the battery compartment 14 are integrated. The electronic control compartment 13 mainly arranges a circuit board inside the housing of the leadless pacemaker 10. The circuit of the electronic control compartment 13 can deliver pacing pulses to the muscles of the heart cavity through the distal electrode 12, sense the electrical activity from the muscles, or communicate bidirectionally with at least one other device inside or outside the body. The battery compartment 14 is connected to the electronic control compartment 13 and mainly arranges a battery inside the housing of the leadless pacemaker 10. The battery provides power for pacing, sensing, and communication for the circuit. The connection feature 15 is located at the proximal end of the leadless pacemaker 10 and is connected to the housing. During delivery or retrieval, the leadless pacemaker 10 is connected to the catheter system through the connection feature 15. It should be noted that the connection feature 15 can adopt any shape as long as the connection feature 15 is suitable for being pulled into the docking cap 210 described later and interferes with or engages with the corresponding feature inside the docking cap 210 during torque transmission.

[0057] It should be noted that the above description of the leadless pacemaker 10 is not a limitation on the structure of the implantable cardiac pacemaker, nor is it a limitation on the structure of the biostimulator of the present invention.

[0058] As described below, the leadless pacemaker 10 or other biostimulators can be delivered to the target position in the body or removed from the body using a catheter system.

[0059] Figure 3 The structural schematic diagram of a catheter system provided according to an embodiment of the present invention is shown. As Figure 3 shown, the catheter system may include a catheter assembly 100 and a docking assembly 200; the docking assembly 200 is installed at the distal end of the catheter assembly 100. The catheter system may further include a handle member (not shown), and the handle member is installed at the proximal end of the catheter assembly 100. The operator can manipulate the catheter assembly 100 by operating the handle member at the proximal end to achieve different functions of the catheter system, and the connection and cooperation between the lumens of the catheter assembly 100 are achieved through the docking assembly 200.

[0060] Refer to Figures 3 to 5, the catheter assembly 100 may include an outer sleeve 110, a steering tube 120, and a torque tube 130 arranged from outside to inside in sequence (the torque tube 130 is hidden inside Figure 3 the illustrated steering tube 120). The outer sleeve 110 is the outermost catheter, positioned along the steering tube 120, and can be advanced or retracted to cover or expose the docking cap 210 and the biostimulator. The steering tube 120 is located inside the outer sleeve 110 and is used to regulate the configuration of the distal end of the catheter system. The distal end of the steering tube 120 is controlled by a proximal handle component and deflected to an expected angle, thereby controlling the catheter system to pass through the curved blood vessels or heart configuration in the human body. The torque tube 130 is located inside the steering tube 120 and is used to transmit the torque of the proximal handle component, so that the docking assembly 200 drives the biostimulator to make a rotational movement around the central axis of the catheter system.

[0061] The above-mentioned outer sleeve 110, steering tube 120, and torque tube 130 are pairwise matched through the docking assembly 200 to achieve different functions.

[0062] Figures 6 to 8 FIG. shows a schematic structural diagram of a docking assembly 200 provided according to an embodiment of the present invention. As Figures 6 to 8 shown, the docking assembly 200 may include a docking cap 210 and a rotating base 220; the rotating base 220 is inserted into the docking cap 210 from the proximal end of the docking cap 210. Specifically, the rotating base 220 may be partially or fully inserted into the docking cap 210. More preferably, the rotating base 220 is partially inserted into the docking cap 210.

[0063] The docking cap 210 and the rotating base 220 can be made of any suitable material as long as the docking cap 210 and the rotating base 220 have a certain strength and a low surface friction coefficient. In some embodiments, the docking cap 210 and the rotating base 220 are made of metal materials, such as stainless steel, titanium alloy, etc. In some embodiments, the docking cap 210 and the rotating base 220 are made of polymer materials with a low surface friction coefficient and a certain strength, such as polyoxymethylene (POM), polyether ether ketone (PEEK), etc. In some embodiments, the docking cap 210 and the rotating base 220 are made of ceramic materials.

[0064] During application, the rotary base 220 and the docking cap 210 are connected to the bending control tube 120 and the torsion tube 130 in a one-to-one correspondence. More specifically, the rotary base 220 is installed at the distal end of the bending control tube 120. The distal end of the bending control tube 120 can be inserted into the rotary base 220 and fixed by various means, such as welding, riveting, or bonding, etc.; while the docking cap 210 is installed at the distal end of the torsion tube 230. The distal end of the torsion tube 130 can be inserted into the docking cap 210. Similarly, it can be fixed by various means such as welding, riveting, or bonding.

[0065] After the docking assembly 200 of the present invention is connected to the catheter assembly 100, a catheter system is formed. The entire catheter system has the functions of distal deflection and distal rotation, and can also engage a bio-stimulator through the docking assembly 200 at the distal end. For example, the corresponding features on the docking cap 210 can cooperate with the corresponding features on the bio-stimulator, so that the torsion tube 130 can apply torque to the bio-stimulator to screw the fixing device 11 on the bio-stimulator into the tissue, or unscrew and remove the fixing device 11 from the tissue. Therefore, the rotation of the bio-stimulator needs to be controlled through the docking assembly 200 at the distal end of the catheter system.

[0066] Although the existing devices involving docking caps can also meet the usage requirements, generally they have complex structures, large sizes, and high costs. Therefore, the present invention optimizes the connection method between the docking cap 210 and the rotary base 220, aiming to simplify the structure and reduce the overall size on the premise of meeting the usage requirements.

[0067] Figures 16 to 19 The structural schematic diagram of the rotary base 220 provided according to an embodiment of the present invention is shown. As Figures 16 to 19 shown, an annular groove 220a is provided on the outer side of the rotary base 220. The annular groove 220a is an annular depression continuously distributed around the outer periphery of the rotary base 220. It should be noted that such an annular groove 220a can be the illustrated arc-shaped groove (i.e., the cross-section is arc-shaped), or rectangular or other cross-sectional shapes, as long as it can cooperate with the protruding part 211 described later, is not easily disengaged, and also allows the docking cap 210 to rotate on the rotary base 220. It should be noted that there is at least one annular groove 220a on the outer side of the rotary base 220, and each annular groove 220a has a corresponding protruding part 211 to cooperate with.

[0068] Figures 8 to 10 and Figure 22 The structural schematic diagram of the docking cap 210 provided according to an embodiment of the present invention is shown. As Figures 8 to 10 and Figure 22 shown, at least one protruding part 211 is provided on the inner side of the docking cap 210.

[0069] Next, refer toFigures 8 - 9 and Figure 19 , the protruding portion 211 is embedded in the annular groove 220a to realize the connection between the docking cap 210 and the rotary base 220. More specifically, through the cooperation between the protruding portion 211 and the annular groove 220a, the docking cap 210 and the rotary base 220 are connected. After the connection, on the one hand, the relative movement between the docking cap 210 and the rotary base 220 is restricted, and on the other hand, the relative rotation between the docking cap 210 and the rotary base 220 is allowed, and the rotation angle can reach 360°, with basically no dead points.

[0070] It can be seen that the present invention can replace the traditional bearing connection method through the connection method of the cooperation between the protruding portion 211 and the annular groove 220a to realize the interconnection between the docking cap 210 and the rotary base 220. It can not only restrict the displacement of the docking cap 210 in the axial direction, but also avoid the docking cap 210 driving the biological stimulator to extend further distally during the bending deflection, causing unexpected damage to blood vessels or the heart. It can also ensure the rotation of the docking cap 210 on the rotary base 220 without affecting the torque transmission, which preferably meets the requirement of distal rotation. The traditional bearing connection method requires the setting of structures such as a bearing housing, a bearing retainer, and inner and outer bearing rings, with a complex structure and a relatively large overall size. Therefore, on the premise of meeting the use requirements, the technical solution of the present invention can replace complex connection methods such as traditional bearings, greatly simplify the overall structure, simplify the process, reduce costs, and at the same time greatly reduce the overall size of the docking assembly 200, making the docking assembly 200 of the present invention have a smaller size compared with similar products.

[0071] Since the overall size of the docking assembly 200 is reduced, the distal length of the non-bendable catheter system formed by the docking cap 210 and the biological stimulator becomes shorter, and thus the turning radius of the entire catheter system in blood vessels and the heart is smaller, improving the intraoperative operation flexibility and accuracy, reducing the surgical operation difficulty, and increasing the surgical safety. Moreover, when assembling the docking cap 210 and the rotary base 220, complex operations are no longer required, making the assembly simpler, more efficient, and less costly.

[0072] It should be understood that when the protruding portion 211 cooperates with the annular groove 220a, it can be surface contact or line contact. Refer to Figure 8 and Figure 9, the protruding part 211 and the annular groove 220a are preferably in line contact. The area of line contact is small. Correspondingly, the frictional force during the twisting control is small, thereby increasing the accuracy and safety of the twisting control operation. When line contact is adopted, the protruding part 211 may have a convex arc surface, and the annular groove 220a is arranged as an arc groove to form a smaller contact surface. Generally speaking, on the premise of being able to stably support the docking cap 210, the contact area between the protruding part 211 and the annular groove 220a is minimized as much as possible so that during the torque transmission, the frictional force received by the relative movement of the protruding part 21 on the annular groove 220a is small. It should be noted that in order to achieve the line contact between the protruding part 211 and the annular groove 220a, the diameter of the protruding part 211 is slightly smaller than the inner diameter of the annular groove 220a.

[0073] It should also be understood that a continuously distributed one protruding part 211 may be provided on the inner side of the docking cap 210, or a plurality of discontinuously distributed protruding parts 211 may be provided. For example, the protruding part 211 may be provided as two, three or more, and preferably, 2 to 4 protruding parts 211 are provided. The protruding part 211 may be longer or shorter, and may also adopt any shape as long as it can limit the relative movement between the docking cap 210 and the rotating base 220 and also allow the relative rotation between the docking cap 210 and the rotating base 220. In addition, to ensure uniform force on the docking cap 210, the plurality of protruding parts 211 are evenly distributed circumferentially around the central axis of the docking assembly 200.

[0074] The protruding part 211 and the docking cap 210 may be integrally designed, that is, the protruding part 211 and the docking cap 210 are integrally formed. When integrally formed, the docking cap 210 can be elastically deformed, and the rotating base 220 is snapped into the proximal end of the docking cap 210 under the push of an external force, and the step of installing the protruding part 211 can be omitted. However, considering that the integral design will increase the process complexity and difficulty and increase the manufacturing cost. Therefore, in this embodiment, the protruding part 211 and the docking cap 210 are separately designed, that is, the protruding part 211 and the docking cap 210 are separately formed. When separately formed, first position the docking cap 210 and the rotating base 220, and then separately insert the protruding part 211 between the docking cap 210 and the rotating base 220 and embed it in the annular groove 220a.

[0075] Refer to Figures 8 - 9 , and engagement Figure 19 and Figure 21 , in one embodiment, the docking assembly 200 further includes a connecting shaft 230 separately formed from the docking cap 210. As Figure 21 shown, the shape of the connecting shaft 230 is simple, convenient for processing and manufacturing, and correspondingly, easy to install and fix.

[0076] The connecting shaft 230 is generally in the shape of a round rod, which can support the docking cap 210 and rotate together with the docking cap 210 to achieve the function of the docking cap 210 transmitting torque. Therefore, the connecting shaft 230 is directly set as the protruding part 211 and inserted into the annular groove 220a, thereby realizing the connection between the docking cap 210 and the rotating base 220. This connection method is relatively simpler and has lower cost. During installation, the rotating base 220 can be first inserted into the docking cap 210. After determining the position, the connecting shaft 230 is inserted from the outside between the docking cap 210 and the rotating base 220, so that the connecting shaft 230 is exactly inserted into the annular groove 220a and is radially located between the docking cap 210 and the rotating base 220.

[0077] In this case, both ends of the connecting shaft 230 are fixedly connected to the docking cap 210. Refer to Figures 11 to 15 , and Figures 20 - 21 . In an embodiment, an installation hole 212 is formed on the docking cap 210. The axis of the installation hole 212 neither intersects nor is parallel to the central axis of the docking cap 210. Generally, the axis of the installation hole 212 is skew perpendicular to the central axis of the docking cap 210. The installation hole 212 can extend from one side of the docking cap 210 to the opposite side to form a through hole or a blind hole. Therefore, when installing the connecting shaft 230, the connecting shaft 230 is inserted into the installation hole 212 from one side of the docking cap 210, and the connecting shaft 230 can extend from one side of the docking cap 210 to the opposite side, so that the connection between the docking cap 210 and the rotating base 220 can be completed quickly and conveniently, with a simple structure and very convenient installation. The fixing method between the connecting shaft 230 and the installation hole 212 can be at least one of interference fit, welding, and bonding. The present invention is not limited thereto.

[0078] Considering that blood may flow into the docking cap 210 after the installation hole 212 is formed on the side surface of the docking cap 210, therefore, in an embodiment, the open end of the installation hole 212 is sealed with glue after the connecting shaft 230 is inserted. Specifically, when one end of the installation hole 212 is open to form a blind hole, after the connecting shaft 230 is inserted, one open end is sealed with glue to prevent blood from flowing into the docking cap 210 from the open end; when both ends of the installation hole 212 are open to form a through hole, after the connecting shaft 230 is inserted, both open ends are sealed with glue.

[0079] Continue to refer to Figure 8 and Figure 9, the connecting shaft 230 is in the shape of a round rod and at least partially embedded in the annular groove 220a. In this way, through the cooperation of the connecting shaft 230 and the annular groove 220a, the interconnection of the docking cap 210 and the rotating base 220 can be achieved, preventing the docking cap 210 from disengaging from the rotating base 220, but not hindering the rotation of the docking cap 210 on the rotating base 220. Moreover, the contact between the round rod and the arc-shaped groove is a line contact, with a small friction force.

[0080] It can be seen that the present invention can connect the docking cap 210 and the rotating base 220 through a separate connecting shaft 230, limit the axial displacement of the docking cap 210. In particular, the connecting shaft 230 can provide a small contact area, enabling the docking cap 210 to rotate uniformly with a low friction force, avoiding the rotation stroke blockage or "creeper" rotation phenomenon caused by excessive friction, and thus avoiding additional damage to the heart caused by over-rotation.

[0081] The connecting shaft 230 can be made of a metal material with a certain strength, such as stainless steel, titanium alloy, etc., or a polymer material with a low surface friction coefficient and a certain strength at a certain diameter, such as polyoxymethylene (POM), polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), etc. The connecting shaft 230 can also be made of a ceramic material.

[0082] Preferably, there are multiple connecting shafts 230. The multiple connecting shafts 230 are evenly arranged circumferentially around the central axis of the docking assembly 200, which is equivalent to the uniform circumferential arrangement of multiple protruding parts 211. More preferably, 2 to 4 connecting shafts 230 are used. Both ends of each connecting shaft 230 are fixed in a corresponding mounting hole 212 on the docking cap 210. Specifically, in this embodiment, there are two connecting shafts 230, which are symmetrically arranged, which can not only stably support the docking cap 210, but also ensure the uniform rotation of the docking cap 210 during torsion control.

[0083] Further, in some application scenarios, the distal end of the outer catheter 110 is set as a contrast agent outlet, and the contrast agent introduced into the proximal end flows through the internal channel of the catheter system to the distal end of the outer catheter 110. The internal channel is usually arranged between the bending control catheter 120 and the outer catheter 110, and extends axially from the proximal end of the catheter assembly 100 to the distal ends of the bending control catheter 120 and the outer catheter 110. However, in actual use, it includes but is not limited to the use of contrast agents.

[0084] Further, to achieve a smaller size than products of the same type, in one embodiment, the outer shape of the docking cap 210 is set to match the inner cavity at the distal end of the outer sleeve 110, minimizing the radial dimension of the docking assembly 200. Or rather, the external shape and size of the docking cap 210 match the shape and size of the inner cavity at the distal end of the outer sleeve 110. However, doing so may also cause another problem: when the clearance between the docking assembly 200 and the outer sleeve 110 is too tight, it will cause problems such as poor flow of contrast agent and the like.

[0085] For this reason, in one embodiment, one or more windows 213 that penetrate the interior are provided on the docking cap 210. The windows 213 are provided on the side surface of the docking cap 210 and communicate with the inner cavity of the docking cap 210. The windows 213 are preferably provided at positions on the docking cap 210 corresponding to the interference with the outer sleeve 110, and the interference position is the position where the clearance fit is tight. To prevent the outer periphery of the docking cap 210 from being completely blocked by the outer sleeve 110, affecting the flow of contrast agent and the like, the windows 213 are provided. Specifically, an internal channel for the flow of contrast agent and the like is reserved between the bending control tube 120 and the outer sleeve 110, and the contrast agent and the like flow towards the distal end of the system through the internal channel and the windows 213 until they flow out from the distal opening of the outer sleeve 110. Therefore, through the windows 213, the contrast effect during the operation can be improved.

[0086] Reference Figures 11 to 15 , as an example, two windows 213 are opened on the docking cap 210, the two windows 213 are arranged opposite to each other, and each window 213 extends a certain length distally from the proximal end face of the docking cap 210 and is located at the position where the docking cap 210 interferes with the outer sleeve 110.

[0087] Furthermore, it is also found through research that after the connecting shaft 230 is inserted between the docking cap 210 and the rotating base 220, if the gap between the docking cap 210 and the rotating base 220 is too large, and then when the docking cap 210 deviates from the central axis and shakes, a situation of multi-point frictional contact between the docking cap 210 and the rotating base 220 will occur. For this reason, in one embodiment, the docking assembly 200 further includes a gasket (not shown) for reducing multi-point frictional contact, and the gasket is radially located between the docking cap 210 and the rotating base 220 to improve the above situation. The gasket is made of various polymer materials with a low coefficient of friction, such as polyoxymethylene POM, polytetrafluoroethylene PTFE, polyetheretherketone PEEK, etc., or the gasket can also be made of ceramic materials, and the specific material is not limited.

[0088] Reference Figure 3, in one embodiment, the outer sheath 110 is configured as a variable-diameter tube. Specifically, the outer sheath 110 is provided with a thick-diameter section 111 and a thin-diameter section 112, and a variable-diameter section 113 is provided between the thick-diameter section 111 and the thin-diameter section 112 for transition. The diameter (including the inner diameter and the outer diameter) of the thick-diameter section 111 is greater than the diameter of the thin-diameter section 112, and the diameter of the variable-diameter section 113 gradually increases from the proximal end to the distal end. The maximum diameter of the variable-diameter section 113 is the same as the diameter of the thick-diameter section 111. The minimum diameter of the variable-diameter section 113 is the same as the diameter of the thin-diameter section 112. The thick-diameter section 111 is located at the most distal end of the outer sheath 110 and is used as a protective sheath for the biological stimulator.

[0089] Reference Figures 9 - 10 , and in combination with Figure 23 , the thick-diameter section 111 of the outer sheath 110 can cover the leadless pacemaker 10 and the docking cap 210. It should be understood that the entire biological stimulator is covered by the thick-diameter section 111 of the outer sheath 110 during the delivery or retrieval process, avoiding additional damage to blood vessels and cardiac structures by the fixing device 11 before being implanted into the intended position. In one embodiment, the outer sheath 110 is retracted proximally with respect to the catheter system, exposing the leadless pacemaker 10 and the docking cap 210, and then by manipulating the proximal handle member to transmit the torque distally, the docking cap 210 can be controlled to drive the biological stimulator to rotate around the central axis of the catheter system.

[0090] In addition, the inner diameter of the thick-diameter section 111 is greater than the overall outer diameter of the docking cap 210, so that the thick-diameter section 111 can pass through the docking cap 210 to achieve full coverage of the biological stimulator. It can also be concluded therefrom that there is a gap between the inner wall of the thick-diameter section 111 and the outer periphery of the docking cap 210. Of course, this gap is not too large, and in the case of minimizing the radial dimension, it can pass through contrast agents and the like.

[0091] Figure 14 and Figure 15 show a front view of the docking cap 210 provided according to an embodiment of the present invention. As Figure 14 and Figure 15As shown, in one embodiment, the docking cap 210 is axially provided with a distal flange region 2101, an intermediate region 2102, and a proximal connection region 2103 in sequence from the distal end to the proximal end. The intermediate region 2102 is concave relative to the distal flange region 2101 and the proximal connection region 2103 to form a concave space around the intermediate region 2102. However, the intermediate region 2102 may also be only concave relative to the distal flange region 2101, that is, the outer diameter of the proximal connection region 2103 may be set to be the same as the outer diameter of the intermediate region 2102. It should be noted that the main function of the proximal connection region 2103 is to allow the rotary base 220 to be inserted and connected to the rotary base 220. Therefore, a protruding portion 211 such as a connecting shaft 230 is provided on the proximal connection region 2103. This portion needs to ensure structural strength, so the proximal connection region 2103 requires a certain thickness. At the same time, the proximal connection region 2103 of the docking cap 210 abuts against the outer sleeve 110 to prevent the outer sleeve 110 from displacing relative to the bending control tube 130 during bending offset. The main function of the distal flange region 2101 is to dock with the biological stimulator and provide stable support for the biological stimulator.

[0092] Specifically, the distal flange region 2101 is cup-shaped, and the outer diameter increases distally from the intermediate region 2102 to form a flange flange shape. Refer to Figure 9 , Figure 20 and Figure 22 , in one embodiment, a flared opening 2104 is formed inside the distal flange region 2101, and the flared opening 2104 of the distal flange region 2101 matches the proximal feature 10A of the leadless pacemaker 10. When the biological stimulator is pulled into the docking cap 210, the proximal feature 10A of the biological stimulator can be abutted through the flared opening 2104, thereby limiting the biological stimulator. Moreover, the contact area between the docking cap 210 and the biological stimulator is increased, which can provide stable support and enable the docking cap 210 to better drive the biological stimulator to rotate together.

[0093] Refer to Figures 9 - 10 , there is a gap between the outer periphery of the distal flange region 2101 and the inner wall of the thick diameter section 111 of the outer sleeve 110, and the outer periphery of the proximal connection region 2103 is in close fit with the inner wall of the reduced diameter section 113 of the outer sleeve 110. In this way, the outer shape of the docking cap 210 can match the inner cavity at the distal end of the outer sleeve 110, minimizing the radial dimension of the distal end of the catheter system.

[0094] In addition, the outer diameter of the distal flange region 2101 may be greater than or equal to the outer diameter of the proximal connection region 2103. Preferably, the outer diameter of the distal flange region 2101 is the same as the outer diameter of the proximal connection region 2103, so as to increase the wall thickness of the proximal connection region 2103 without reducing the structural strength at the proximal connection region 2103. Preferably, the outer shape of the docking cap 210 is configured to interfere with the inner cavity of the reduced-diameter section 113 to limit the axial movement of the docking cap 210 toward the proximal end of the catheter system.

[0095] Specifically, the inner cavity of the reduced-diameter section 113 of the outer sleeve 110 can interfere with the proximal connection region 2103 of the docking cap 210, that is, the inner diameter of the reduced-diameter section 113 at a certain position does not exceed the outer diameter of the proximal connection region 2103 and interference occurs, so that the outer sleeve 110 is just stuck at the interference position of the reduced-diameter section 113, thereby defining the relative position of the docking cap 210 and the outer sleeve 110. Especially during the controlled bending and deflection process, the movement or crosstalk of the docking cap 210 toward the proximal end of the catheter system can be restricted, improving the operation accuracy. Preferably, the reduced-diameter section 113 interferes with the proximal connection region 2103 at its maximum inner diameter (see Figure 9 detail A therein). Preferably, one or more windows 213 are provided on the docking cap 210 corresponding to the position where it interferes with the reduced-diameter section 113.

[0096] Refer to Figure 20 , in one embodiment, a central hole 2105 for inserting the distal end of the torsion tube 130 is provided in the inner cavity of the docking cap 210, and the central hole 2105 is provided on the partition 2106. The partition 2106 can divide the inner cavity of the docking cap 210 into two parts. The inner cavity proximal to the partition 2106 is used to accommodate the rotary base 220, and the inner cavity distal to the partition 2106 is used to accommodate the biological stimulator. The inner cavity distal to the partition 2106 can be of any shape that allows the accommodation of the biological stimulator.

[0097] Refer to Figure 12 and Figure 13 , a positioning feature 2107 that interferes with the connection feature 15 of the biological stimulator during rotation along the central axis is provided in the inner cavity distal to the partition 2106. The positioning feature 2107 enables the docking cap 210 to drive the biological stimulator to rotate together. Therefore, the torsion tube 130 can be configured to apply torque to the biological stimulator to unscrew and remove the biological stimulator from the tissue during retrieval. During delivery, the fixing device 11 is screwed into the target tissue. The positioning feature 2107 is a boss and / or a notch. In this embodiment, the positioning feature 2107 is a boss that interferes with or engages with the connection feature 15.

[0098] Further, when advancing the outer sleeve 110, in order to enable the outer sleeve 110 to pass through the docking assembly 200, a tapered section 201 can be provided on the docking assembly 200. The tapered section 201 extends axially distally from the end face of the proximal end of the docking assembly 200 by a certain length. See Figures 7 to 9 . In the present invention, the outer sleeve 110 is guided by the tapered section 201, so that the thick-diameter section 111 of the outer sleeve 110 can smoothly climb the slope and pass through the docking cap 210. In some cases, the rotary base 220 is entirely inserted into the docking cap 210 and completely wrapped by the docking cap 210. At this time, the tapered section 210 is entirely provided on the docking cap 210, and the outer sleeve 110 is directly guided by the tapered section 201 on the docking cap 210. The entire tapered section 201 should have an appropriate inclination angle.

[0099] As described above, more preferably, the rotary base 220 is partially inserted into the docking cap 210. At this time, the proximal portion 221 of the rotary base 220 is exposed outside the docking cap 210, which is convenient to guide the outer sleeve 110 through the exposed proximal portion 221 of the rotary base 220. That is, the tapered section 201 is provided in sections on the docking cap 210 and the rotary base 220. The first part of the tapered section 201 is provided on the proximal connection area 2103 of the docking cap 210, and the second part 201 of the tapered section 201 is provided on the proximal portion 221 of the rotary base 220.

[0100] The proximal portion 221 of the rotary base 220 is generally cup-shaped, so that the entire outer peripheral surface of the proximal portion 221 is the tapered section 201. The tapered section 201 of the proximal portion 221 slopes outward in the direction from the proximal end N to the distal end F, and its inclination angle can remain unchanged or vary uniformly. The rotary base 220 extends distally from the distal end of the proximal portion 221 to form a distal portion 222, and the distal portion 222 is inserted into the docking cap 210. The distal portion 222 is substantially cylindrical. The annular groove 220a is provided on the distal portion 222 of the rotary base 220.

[0101] Preferably, the outer diameter of the distal portion 222 is smaller than the maximum outer diameter of the proximal portion 221, so that a step 223 is formed axially between the distal portion 222 and the proximal portion 221. The proximal end of the docking cap 210 abuts against the step 223. Through the step 223, the wall thickness of the proximal connection area 2103 of the docking cap 210 can be increased, and the structural strength of the proximal connection area 2103 can be enhanced.

[0102] More preferably, a fillet is provided at the end face of the proximal end of the first part of the tapered section 201. On the one hand, the fillet will not damage the blood vessel, and on the other hand, the fillet is convenient to guide the outer sleeve 110 to climb the slope and pass through the first part of the tapered section 201.

[0103] Whether part or all of the rotating base 220 is inserted into the docking cap 210, the axial length of the docking assembly 200 is preferably kept unchanged. That is, the axial length of the docking assembly 200 formed when part of the rotating base 220 is inserted into the docking cap 210 is preferably the same as the axial length of the docking assembly 200 formed when the rotating base 220 is fully inserted into the docking cap 210, ensuring that the axial dimension of the docking assembly 200 is minimized.

[0104] In particular, when part of the rotating base 220 is inserted into the docking cap 210, the proximal end of the docking assembly 200 can be made gentle without weakening the structural strength of the proximal connection region 2103 of the docking cap 210, facilitating the passage of the outer sheath 110 and reducing the difficulty of advancing the outer sheath 110 during the operation, especially when the catheter is in a bent state. Specifically, when the outer sheath 110 is positioned along the curved steering tube 120, the outer sheath 110 may deviate from the center. If the slope of the proximal end of the docking assembly 200 is inappropriate, it will be difficult for the outer sheath 110 to climb over the docking assembly 200. Therefore, the slope of the proximal end of the docking assembly 200 should be as gentle as possible.

[0105] Specifically, the tapered section 201 of the docking assembly 200 has a constant slope or a variable slope, and the gentler the slope, the easier it is for the outer sheath 110 to climb over the docking assembly 200 and reach the position of the biological stimulator smoothly.

[0106] However, the gentler the slope, the longer the required axial length. If the entire tapered section 201 is provided on the docking cap 210, the tapered section 201 will necessarily extend to the position where the docking cap 210 has the protruding portion 211, reducing the wall thickness at the position of the protruding portion 211 and lowering the structural strength.

[0107] To solve the contradiction between the "slope" and the "length", in this embodiment, part of the rotating base 220 is inserted into the docking cap 210, and the tapered section 201 is divided into two parts. The first part of the tapered section 201 extends axially distally from the proximal end face of the docking cap 210 to the proximal side of the protruding portion 211, and the second part of the tapered section 201 extends axially distally from the proximal end face of the rotating base 220 and terminates at the distalmost end of the proximal portion 221, that is, at the position of the proximal end face of the docking cap 210. In this way, it can ensure that the slope of the entire tapered section 201 is gentle enough, without affecting the structural strength of the protruding portion 211, and without increasing the axial dimension of the docking assembly 200.

[0108] The slope of the second part is the same as or different from that of the first part. Preferably, the slope of the second part is gentler than that of the first part, which can better guide the outer sleeve 110. Further, the slope of the entire tapered section 201 on the docking assembly 200 matches the slope of the diameter-changing section 113 of the outer sleeve 110, reducing the difficulty of arranging the docking cap 210 and the rotating base 220 at the diameter-changing section 113.

[0109] Further, the catheter system may include a tethering device (not shown), and the distal end of the tethering device may engage the connection feature 15 of the biostimulator. The tethering device may axially extend from the proximal handle member through the central lumen of the torque tube 130 and enter the external environment distal to the docking cap 210. The tethering device may include various structures such as wires, shafts, tubes, ropes, etc. that can extend through the catheter assembly 100. The tethering device firmly secures the biostimulator to the docking assembly 200, enabling the biostimulator to stably rotate around the central axis on the rotating base 220 together with the docking cap 210 after being secured. Since the tethering device is easily implemented by those skilled in the art based on their common knowledge, the present invention will not elaborate on this part of the content.

[0110] In summary, it can be seen that through reasonable size design and spatial layout, the present invention can make the docking assembly 200 have a smaller size than similar products. This includes minimizing the axial dimensions of the docking cap 210 and the rotating base 220. Further, the outer dimensions of the docking cap 210 can be matched with the inner cavity dimensions of the outer sleeve 110 to minimize the radial dimensions of the docking cap 210 and the rotating base 220. Finally, the operation flexibility and accuracy of the catheter system inside the human blood vessels and heart can be improved. Moreover, compared with similar products, the present invention is simpler to assemble and has a lower cost.

[0111] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

1. A docking assembly, characterized in that: It comprises a docking cap and a rotating base; the rotating base is at least partially inserted into the docking cap; an annular groove is provided on the outer side of the rotating base; and at least one protruding portion is provided on the inner side of the docking cap; The protruding portion is embedded in the annular groove and cooperates with the annular groove to connect the docking cap and the rotating base, and restricts the relative movement of the docking cap and the rotating base, and allows the relative rotation of the docking cap and the rotating base.

2. The docking assembly according to claim 1, characterized in that: The docking cap is provided with one or more windows communicating with the interior, and / or the shape of the docking cap is configured to match the inner cavity at the distal end of the outer sleeve.

3. The docking assembly according to claim 1, characterized in that: The docking assembly also includes a connecting shaft that is separately formed from the docking cap, and the connecting shaft is configured as the protruding portion to be embedded in the annular groove; the connecting shaft is radially located between the docking cap and the rotating base, and both ends of the connecting shaft are fixedly connected to the docking cap.

4. The docking assembly according to claim 3, characterized in that: The plurality of connecting shafts are evenly arranged circumferentially around the central axis of the docking assembly, and / or the docking cap is provided with a mounting hole, which is a through hole or a blind hole, and the two ends of the connecting shaft are inserted into a corresponding mounting hole and fixedly connected, and the open end of the mounting hole is sealed with glue after the connecting shaft is inserted.

5. The docking assembly according to claim 1, characterized in that: The protruding portion is in line contact with the annular groove.

6. The docking assembly according to claim 5, characterized in that: The protruding portion has an outwardly convex arc surface, and the annular groove is configured as an arc groove.

7. The docking assembly according to claim 1, characterized in that: The docking assembly also includes a gasket for reducing multi-point frictional contact, wherein the gasket is radially located between the docking cap and the rotating base.

8. The docking assembly according to claim 1, wherein: The rotating base is partially inserted into the docking cap; the docking assembly extends axially distally for a certain length from the proximal end face to form a tapered section; the tapered section is divided into a first part and a second part; the first part extends axially distally from the proximal end face of the docking cap to the proximal side of the protruding part; the second part extends axially distally from the proximal end face of the rotating base and terminates at a position corresponding to the proximal end face of the docking cap.

9. The docking assembly according to claim 8, characterized in that: The slope of the second portion is gentler than that of the first portion, and / or a step is provided on the rotating base at a position corresponding to the proximal end surface of the docking cap, and the proximal end of the docking cap stops at the step.

10. A catheter system, characterized in that: include: A catheter assembly and a docking assembly as described in any one of claims 1 to 9; the catheter assembly comprises an outer sleeve, a bending control tube and a torque tube arranged in sequence from the outside to the inside; the rotating base is installed at the distal end of the bending control tube; the docking cap is installed at the distal end of the torque tube.

11. The catheter system of claim 10, wherein: The outer sleeve has a thick diameter section, a reduced diameter section and a thin diameter section arranged in sequence from far to near along its own axial direction; the inner diameter of the thick diameter section is larger than the outer diameter of the docking assembly; the shape of the docking cap is arranged to be able to interfere with the inner cavity of the reduced diameter section.

12. The catheter system of claim 11, wherein: The docking cap is provided with one or more windows communicating with the interior at positions corresponding to the interference with the reducing section, and / or the docking assembly extends axially distally for a certain length from the nearest end face to form a tapered section, the slope of which matches the slope of the reducing section.

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