A rotatable head end assembly and catheter

Abstract

The application provides a rotatable head end assembly and a catheter, and relates to the technical field of medical devices, and solves the problem of easy kinking of a stent during delivery and release. The rotatable head end assembly of the catheter comprises a base pipe body and a rotating member, the rotating member is axially positioned and connected to the inner circumferential wall of the base pipe wall and can rotate relative to the base pipe wall. The rotating member is used for radially contacting and extruding at least part of the axial section of the outer circumferential surface of the stent placed in the lumen of the base pipe, so that the twisted stent can transmit the torque to the rotating member to drive the rotating member to rotate relative to the base pipe wall, thereby gradually releasing the torque, relieving or eliminating the torsional difference between the distal end and the proximal end of the stent, and preventing the stent from being kinked to a certain extent during delivery and release.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a rotatable tip assembly and a catheter. Background Technology

[0002] The routine clinical delivery and deployment of endovascular stents (including intracranial, coronary, and peripheral stents) and other cavity stents all rely on catheter-based access. In related technologies, catheters used for stent delivery are mostly made of rigid or semi-rigid materials, with a single, integrated cavity design, and their tips are strictly coaxial. These catheters achieve stable support of the stent through the friction between their inner wall and the stent, preventing stent detachment during delivery and enabling axial pushing and retraction.

[0003] Because human blood vessels or other cavities have natural tortuosity, bifurcation, and rotation angles, complications such as stent kinking and poor opening can easily occur during the delivery and release of stents through catheters. Summary of the Invention

[0004] The purpose of this invention is to design a rotatable head assembly and catheter to solve the problem of easy kinking during stent delivery and release.

[0005] This invention is achieved through the following technical solution: In a first aspect, some embodiments of the present invention provide a rotatable tip assembly for a catheter, the rotatable tip assembly including a base tube body and a rotating member; the base tube body includes a base tube wall extending axially from a distal end to a proximal end, the inner side of the base tube wall forming an axially penetrating base tube lumen; the rotating member is axially positioned and connected to the inner peripheral wall of the base tube wall and is rotatable relative to the base tube wall, the rotating member being used to radially contact and compress at least a portion of the axial segment of the outer peripheral surface of a stent inserted into the base tube lumen, such that a torsionated stent can transmit torque to the rotating member to drive the rotating member to rotate relative to the base tube wall, thereby gradually releasing the torque.

[0006] To further improve the present invention, the following configuration is adopted: the static friction coefficient between the rotating component and the base pipe wall is less than the static friction coefficient between the base pipe wall and the outer peripheral surface of the support; and / or, the dynamic friction coefficient between the rotating component and the base pipe wall is less than the dynamic friction coefficient between the base pipe wall and the outer peripheral surface of the support.

[0007] To further improve the implementation of the present invention, the following structure is adopted: the inner circumferential wall of the base pipe is provided with an installation groove, and the rotating member is rotatably disposed in the installation groove.

[0008] In some embodiments, the rotating member is configured as a cylindrical member coaxial with the base pipe wall, and the rotating member is rotatable relative to the base pipe wall about the axis of the base pipe wall.

[0009] In some embodiments, multiple rotating members are provided and are configured as annular rings; all rotating members are coaxially arranged with the base pipe wall and are arranged sequentially at intervals along the axial direction; the rotating members are capable of rotating relative to the base pipe wall around the axis of the base pipe wall.

[0010] In some embodiments, multiple rotating components are provided, and they are configured as spheres or rollers; all the rotating components are divided into multiple groups of rotating parts arranged sequentially at intervals along the axial direction of the base pipe wall, and each group of rotating parts includes at least one of the rotating components; the mounting groove is a closed loop around the axis of the base pipe wall; all the rotating components in each group of rotating parts are individually disposed in one mounting groove and arranged sequentially along the circumference of the base pipe wall, and the rotating components can rotate relative to the base pipe wall about their own axis.

[0011] Secondly, some embodiments of the present invention provide a catheter, the catheter including an extension tube body and the aforementioned rotatable tip assembly, wherein the distal end of the extension tube body is coaxially and fixedly connected to the proximal end of the base tube body of the rotatable tip assembly.

[0012] The present invention has the following advantages and beneficial effects: The rotatable tip assembly of this invention is used at the distal end of a catheter. The rotating component of the rotatable tip assembly is rotatably connected to the inner circumferential wall of the base tube. The position of the rotating component can replace the inner circumferential wall of the base tube to constrain the stent, using friction to stabilize and support the stent, preventing stent detachment during delivery. Because the rotating component can rotate relative to the base tube, when the retraction of the base tube causes twisting of the body cavity and pulls on the distal end of the stent, resulting in torsion, the torque generated on the stent can directly act on the rotating component. This allows the rotating component to overcome the relatively small frictional force between itself and the base tube, thus allowing the stent to gradually release torque and alleviate or eliminate the torsional difference between the proximal and distal ends. Therefore, this rotatable tip assembly can, to a certain extent, prevent stent kinking during delivery and release. Attached Figure Description

[0013] To more clearly illustrate the technical solutions in the embodiments of this application 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 some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0014] Figure 1This is a schematic diagram of the catheter structure in some embodiments of this application, in which the distal end of the stent has extended out of the catheter and unfolded; Figure 2 This is a partial appearance schematic diagram of the rotatable head end assembly in some embodiments of this application; Figure 3 This is a schematic diagram of the internal structure of the rotatable head assembly in some embodiments of this application. Figure 1 The red-filled portion in the diagram represents the axial segment where the developing section on the rotating component is located. Figure 4 This is a schematic diagram of the internal structure of the rotatable head assembly in some embodiments of this application. Figure 2 ; Figure 5 This is a schematic diagram of the rotating component in some embodiments of this application; Figure 6 This is a schematic diagram of the internal structure of the rotatable head assembly in some embodiments of this application. Figure 3 ; Figure 7 This is a schematic diagram of the use of catheters in some embodiments of this application. Figure 1 ; Figure 8 This is a schematic diagram of the use of catheters in some embodiments of this application. Figure 2 ; Figure 9 This is a schematic diagram of the connection between the rotating part and the base tube of the rotatable head end assembly in some embodiments of this application. Figure 1 ; Figure 10 This is a schematic diagram of the use of catheters in some embodiments of this application. Figure 3 ; Figure 11 This is a schematic diagram of the connection between the rotating part and the base tube of the rotatable head end assembly in some embodiments of this application. Figure 2 .

[0015] The diagram is marked as follows: 100. Rotatable head end assembly; 10. Foundation pipe body; 11. Foundation pipe wall; 111. Mounting groove; 112. Limiting protrusion ring; 113. Limiting block; 12. Foundation pipe cavity; 20. Rotating component; 21. Developing section; 20a. Rotating section; 22. Window; 200. Extend the tube body; 210. Extend the tube wall; 220. Extend the tube lumen; 300. Catheter; 400, bracket. Detailed Implementation

[0016] To make the objectives, technical solutions, and advantages of this application clearer, the technical solutions of this application will be described in detail below. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments in this application, all other implementation methods obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0017] In the description of this application, it should be noted that, unless otherwise stated, "multiple" means two or more; the terms "upper," "lower," "left," "right," "inner," "outer," "front end," "rear end," "head," "tail," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and 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, and therefore should not be construed as a limitation of this application.

[0018] The terms "first," "second," etc., used in the specification and claims of this application are used to distinguish similar objects and not to describe a specific order or sequence. It should be understood that such terms can be used interchangeably where appropriate so that embodiments of this application can be implemented in orders other than those illustrated or described herein, and the objects distinguished by "first," "second," etc., are generally of the same class and the number of objects is not limited; for example, a first object can be one or more. Furthermore, in the specification and claims, "and / or" indicates at least one of the connected objects, and the character " / " generally indicates that the preceding and following objects are in an "or" relationship.

[0019] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this application depending on the specific circumstances.

[0020] In the various embodiments of this application, "near end" and "far end" refer to the distance of each component from the user in the usage environment. The end closer to the user is designated as the "near end", and the end farther from the user is designated as the "far end".

[0021] Existing catheters used for stent delivery and control all feature a single-lumen design as their core structure, with the distal and proximal ends of the catheter strictly coaxial. The catheters are mostly made of rigid or semi-rigid materials.

[0022] The inventors discovered in production practice that existing catheters are one-piece designs and lack axial rotation adjustment capabilities, only enabling axial pushing and retraction. This easily leads to stent kinking. The core mechanism is as follows: During stent advancement within the catheter lumen, sufficient friction between the stent and the catheter inner wall is required to prevent stent dislodgement. However, when the distal end of the stent rotates due to resistance from vascular tortuosity or bifurcation, the catheter tip cannot follow the rotation, and the proximal end of the stent cannot rotate synchronously due to the frictional force of the catheter inner wall. This results in an imbalance of forces at both ends of the stent, ultimately causing twisting and kinking in the middle segment, obstructing the patency of the stent lumen, and affecting the normal release and apposition of the stent. Furthermore, different types of stents exhibit different kinking characteristics. Braided stents are prone to "coiling" during testing, while cut-type and self-expanding stents, due to their structural characteristics, are more likely to experience distal rotation and proximal fixation in tortuous vessel segments, thus leading to kinking.

[0023] This application discloses a rotatable tip assembly 100 and a conduit 300 disposed thereon. The rotatable tip assembly 100 includes a base tube 10 and a rotating member 20 rotatably connected to the inner peripheral wall of the base tube 10. The rotating member 20 replaces the inner peripheral wall of the base tube 10, applying constraint to the outer peripheral surface of a support 400 inserted into the lumen of the base tube 10. When there is a torsional difference between the proximal and distal ends of the support 400, the support 400 can transmit torque to the rotating member 20, causing the rotating member 20 to rotate, thereby enabling the support 400 to at least alleviate the degree of torsion and prevent kinking.

[0024] The following is in conjunction with the appendix Figures 1-11 The rotatable head assembly 100 and catheter 300 provided in this application will be described in detail through specific embodiments and application scenarios.

[0025] In a first aspect, embodiments of this application disclose a rotatable head assembly 100, such as... Figure 1 As shown, the rotatable tip assembly 100 is used at the distal end of the catheter 300, and the proximal end of the rotatable tip assembly 100 is used to connect with the extension tube 200 to form the entire axial tube segment of the catheter 300.

[0026] The rotatable head assembly 100 includes a base tube 10 and a rotating member 20 rotatably connected together. The rotating member 20 can rotate circumferentially relative to the base tube 10 under the drive of a circumferential external force.

[0027] like Figures 2-4 and Figure 6As shown, the base tube 10 includes a base tube wall 11 that is circumferentially closed around its axis. The base tube wall 11 extends axially continuously from its distal end to its proximal end, such that the inner side of the base tube wall 11 encloses an axially continuous base tube cavity 12. The base tube cavity 12 is axially continuous, with its distal port formed at the distal end face of the base tube wall 11, and its proximal port used to coaxially communicate with the distal port of the extension tube 200 to allow the passage of a guide wire.

[0028] The rotating component 20 is integrally connected to the inner circumferential wall of the base pipe wall 11, which provides a circumferentially surrounding inner circumferential surface. The base pipe wall 11 can radially contact and press the outer circumferential surface of the support 400, which is inserted into the base pipe cavity 12 and located inside the rotating component 20, through its inner circumferential surface, thereby constraining the support 400. The friction between the rotating component 20 and the support 400 is used to stably support the support 400 and prevent the support from detaching during transportation.

[0029] The rotating component 20 is movably connected to the inner circumferential wall of the base tube 11 and can rotate circumferentially relative to the base tube 11 around its axis. When the friction between the rotating component 20 and the base tube 11 is overcome, and the twisting of the human body cavity caused by the retraction of the base tube 10 pulls on the distal end of the support 400, causing torsion, the support 400 can directly transmit its torque to the rotating component 20, thereby driving the rotating component 20 to rotate relative to the base tube 11. This allows the support 400 to gradually release the torque, alleviating or eliminating the torsional difference between the proximal and distal ends. To ensure the axial position of the support 400, the rotating component 20 is axially positioned relative to the base tube 11 to prevent axial movement.

[0030] In this embodiment, the axial length of the rotating member 20 can be designed as needed, for example, the axial length can be between 0.05mm and 10mm, specifically 0.05mm, 0.1mm, 0.5mm, 1mm, 1.5mm, 2mm, 3mm, 5mm, 8mm, and 10mm. For example, the axial length of the rotating member 20 is equal to the axial length of the bracket 400 to be inserted, so that the rotating member 20 can radially contact and compress the entire axial segment of the bracket 400. For example, the axial length of the rotating member 20 is less than the axial length of the bracket 400 to be inserted, so that the rotating member 20 can only radially compress a portion of the axial segment of the bracket 400. Of course, the number of rotating members 20 can be one or more, as long as the axial length occupied by all rotating members 20 meets the requirements.

[0031] In the rotatable head assembly 100 of this embodiment, the rotating member 20 is rotatably connected to the inner peripheral wall of the base tube 10 to rotatably engage with the base tube cavity 12. This arrangement has low friction, making it easier for the support 400 to rotate circumferentially via the rotating member 20 than for it to rotate circumferentially through complete contact with the inner peripheral surface of the base tube cavity 12. (Reference) Figure 7 , Figure 8 and Figure 10 In this embodiment, the rotating member 20 is located inside the base cavity 12 and is used to at least partially replace the inner circumferential wall of the base cavity 12 to constrain the support 400, thereby reducing the circumferential rotational resistance of the support 400.

[0032] To make the rotating component 20 more easily rotate relative to the base pipe wall 11 than the support 400, for example, the static friction coefficient between the rotating component 20 and the base pipe wall 11 is less than the static friction coefficient between the base pipe wall 11 and the outer peripheral surface of the support. For example, the dynamic friction coefficient between the rotating component 20 and the base pipe wall 11 is less than the dynamic friction coefficient between the base pipe wall 11 and the outer peripheral surface of the support.

[0033] In this embodiment, the rotating component 20 in the rotatable head assembly 100 is a structural component made of polymer, metal, or inorganic non-metallic material. Specifically, the material of the rotating component 20 includes, but is not limited to, polymeric materials such as PTFE, ePTFE, FEP, and Pebax, as well as metallic materials such as stainless steel, cobalt-chromium alloy, and nickel-titanium alloy, and inorganic non-metallic materials such as TiO2 and corundum.

[0034] In one application scenario, catheter 300 is inserted along a guidewire into a tortuous diseased blood vessel, and stent 400 is advanced to the target site. The distal end of stent 400 is as follows... Figure 1 , Figure 7 , Figure 8 and Figure 10 As shown, the base lumen 12 of the base tube body 10 of the rotatable tip assembly is first disengaged, unfolded, and anchored to the inner wall of the blood vessel. As the catheter 300 continues to withdraw and release the remaining stent 400, the bending of the blood vessel pulls on the distal end of the stent 400, generating a circumferential torsional moment. Because the proximal end of the stent 400 is constrained by the rotating component 20, the torsional force acts directly on the rotating component 20. The rotating component 20 overcomes minimal friction and follows the proximal end of the stent 400 in circumferential rotation, releasing torsional stress in real time. This alleviates or even eliminates the torsional difference between the proximal and distal ends of the stent 400, preventing mid-segment kinking or curling throughout the process. After the stent 400 is fully released, the catheter 300 is completely withdrawn from the blood vessel.

[0035] As can be seen, the rotatable tip assembly 100 of this embodiment can adaptively rotate and adjust according to the changes in the vascular path during the delivery and release of the stent 400, so as to actively prevent or solve the problem of stent 400 twisting, and can prevent stent 400 from twisting during delivery and release to a certain extent.

[0036] According to some optional embodiments, such as Figures 7-11 As shown, the base pipe body 10 has a radially recessed mounting groove 111 on the inner circumferential wall of the base pipe wall 11. The rotating component 20 is disposed in the mounting groove 111 and can rotate relative to the mounting groove 111.

[0037] In some embodiments, reference is made to Figure 9 and Figure 11 The mounting groove 111 provided on the inner circumferential wall of the base pipe 11 can apply axial and / or radial constraints to the rotating component 20, effectively preventing the nested rotating component 20 from detaching. The mounting groove 111 and the nested rotating component 20 have a small fitting clearance, such as an axial fitting clearance and / or radial fitting clearance of 0.002mm-0.01mm, allowing the rotating component 20 to have low rotational resistance while remaining relatively resistant to detaching from the mounting groove 111. The mounting groove 111 can also be further designed at its opening... Figure 11 The constricted design is used to clamp the rotating component 20 nested within it, thereby improving the radial constraint on the rotating component 20 and preventing it from detaching from the mounting groove 111 when the base tube 10 is bent.

[0038] In some embodiments, such as Figure 2 , Figure 3 , Figures 6-11 As shown, the rotating component 20 is entirely housed within the mounting groove 111. The portion of the rotating component 20 that contacts the outer circumferential surface of the compression bracket 400 is exposed at the opening of the mounting groove 111 and is flush with the inner circumferential surface of the base pipe wall 11. The flush alignment of the portion of the rotating component 20 that contacts the outer circumferential surface of the compression bracket 400 with the inner circumferential surface of the base pipe wall 11 eliminates steps and ensures that the bracket 400 is transported axially without jamming.

[0039] According to some optional embodiments, in order to securely mount the rotating member 20 within the mounting groove 111, the rotating member 20 and the mounting groove 111 are magnetically attracted to each other in the radial direction. For example, the rotating member 20 is configured as a magnetic structural component, and the base pipe wall 11 is ferromagnetic at the position of the mounting groove 111, so that the rotating member 20 is securely attracted to the mounting groove 111 by magnetic force.

[0040] According to some optional embodiments, such as Figure 3 As shown, at least a portion of the rotating member 20 is configured as a radiopaque section 21 to impart radiopaqueness. Specifically, this can be achieved by coating the rotating member 20 with a radiopaque coating or by mixing a high-density radiopaque substance into the material used to manufacture the rotating member 20. In this embodiment, the radiopaque section 21 on the rotating member 20 allows for real-time observation of the rotating member's position during surgery, facilitating precise control of the stent release process by the surgeon.

[0041] According to some optional embodiments, such as Figure 7 , Figure 8 and Figure 10 As shown, in the rotatable head end assembly 100, the axial distance from the rotating member 20 to the far end of the base tube 12 is less than the axial length of the support 400. This allows the rotating member 20 to contact and compress the outer peripheral surface of the support 400 after the base tube 12 of the base tube 10 is pushed out at the far end of the support 400. This enables the rotating member 20 to alleviate the torsional difference of the support 400, rather than just to contact the outer peripheral surface of the support 400 when the base tube 12 of the base tube 10 is not pushed out.

[0042] According to some optional embodiments, such as Figures 2-5 As shown, in this embodiment, the rotating member 20 of the rotatable head assembly 100 is a cylindrical member, and the rotating member 20 is coaxially arranged with the base pipe wall 11. The rotating member 20 is rotatably mounted on the inner peripheral wall of the base pipe wall 11 by magnetic attraction and / or nesting, for example, it is integrally disposed in the mounting groove 111 provided in the inner peripheral wall of the base pipe wall 11. The rotating member 20 can rotate circumferentially relative to the base pipe wall 11 about the axis of the base pipe wall 11.

[0043] The cylindrical rotating part 20 has a peripheral wall thickness of 0.05mm-0.1mm and an axial length of 0.5mm-3mm.

[0044] The frictional force between the cylindrical rotating component 20 and the base pipe wall 11 is controlled at 0.0001N-0.02N so that the rotating component 20 can easily rotate circumferentially relative to the base pipe body 10.

[0045] To reduce surface friction in the cylindrical rotating component 20, a hydrophilic or hydrophobic coating is applied to its inner circumferential surface. This coating can be formed on the surface of the rotating component 20 through methods such as spraying, dip coating, plasma surface treatment, or ionization displacement. The rotating component 20 with the hydrophilic or hydrophobic coating exhibits even lower surface friction, thus reducing thrombus formation. Alternatively, to further reduce surface friction in the cylindrical rotating component 20, its outer circumferential surface can be polished to create a polished surface.

[0046] In some embodiments, reference is made to Figure 4 and Figure 5The rotating component 20 has grooves on its peripheral wall to reduce its rigidity, thus improving its flexibility and allowing it to adapt well to the curvature of human body cavities, resulting in good bending performance. Specifically, grooves are provided on the inner and / or outer peripheral surfaces of the rotating component 20. These grooves can be formed on the rotating component 20 by laser processing or during 3D printing. The grooves can take the form of openwork gaps, angular striped grooves, serpentine cut patterns, wavy cut patterns, etc. The groove depth can be less than the peripheral wall thickness of the rotating component 20 (i.e., it does not penetrate the peripheral wall of the rotating component 20), or it can be equal to the peripheral wall thickness of the rotating component 20 (i.e., as shown in the image). Figure 5 As shown, it penetrates the peripheral wall of the rotating member 20.

[0047] like Figure 4 and Figure 5 As shown, multiple radially penetrating windows 22 are formed on the peripheral wall of the rotating component 20 by laser cutting. The windows 22 extend circumferentially, with a wider axial gap in the middle section, which gradually narrows towards both ends. All the windows 22 are arranged equidistantly along the axial direction and are staggered radially, giving the rotating component 20 good bending flexibility.

[0048] In some embodiments, the rotating member 20 is configured as a cylindrical member with an axial length ≥ 1 mm. In this case, at least a portion of the axial section of the rotating member 20 is configured as a developing section 21. The axial distance between the developing section 21 and the distal end of the base cavity 12 is 0.6 mm-1.2 mm. For example, a developing section of about 1 mm is provided on the developing section 21 at a position 1 mm away from the distal end of the base cavity 12.

[0049] According to some optional embodiments, such as Figure 6 , Figure 8 and Figure 9 As shown, in this embodiment, the rotating member 20 of the rotatable head assembly 100 is configured as a ring coaxially arranged with the base pipe wall 11. In this case, multiple rotating members 20 are provided, and all rotating members 20 are arranged sequentially and spaced apart along the axial direction. Each rotating member 20 is independent of each other and can rotate circumferentially relatively independently relative to the base pipe wall 11 around the axis of the base pipe wall 11. When the support 400 is placed in the base pipe cavity 12, it is constrained by all the rotating members 20. When the base pipe body 10 is pushed out at the distal end of the support 400, the proximal end of the support 400 will disengage from part of the rotating members 40. This can reduce the rotational resistance of the support 400 and make the support 400 easier to rotate during the pushing and releasing process.

[0050] The number of rotating components 20 can be set from 50 to 500 as needed, ensuring that the axial length occupied by all rotating components 20 meets the requirements of the constrained stent 400. To ensure low surface friction of the cylindrical rotating components 20, the outer circumferential surface of the rotating components 20 can be polished to form a polished surface; or a hydrophilic or hydrophobic coating can be applied to the inner circumferential surface of the rotating components 20. To accommodate the general dimensional requirements of catheters used for vascular stent placement, the ring width of the annular rotating components 20 is 0.02 mm to 0.08 mm. The axial distance between two adjacent rotating components 20 is 0.01 mm to 0.02 mm.

[0051] In some embodiments, the annular rotating component 20 is made of nickel-titanium ultrathin tubing or ePTFE extruded ring, with a hydrophilic lubricating coating on the inner circumferential surface and a polished outer wall to reduce rotational resistance.

[0052] like Figure 6 , Figure 8 and Figure 9 As shown, the inner circumferential wall of the base pipe wall 11 is provided with the same number of mounting grooves 111 as the rotating parts 20, and each rotating part 20 is individually disposed in a mounting groove 111. A limiting protrusion ring 112 is formed between two adjacent mounting grooves 111. The limiting protrusion ring 112 is used to maintain the axial distance between two adjacent rotating parts 20 and to prevent the limiting protrusion ring 112 from moving axially.

[0053] According to some optional embodiments, such as Figure 10 and Figure 11 As shown, in this embodiment, the rotating member 20 of the rotatable head end assembly 100 is set as a ball or a roller. In this case, there are multiple rotating members 20. All rotating members 20 are divided into multiple groups of rotating parts 20a arranged sequentially and at intervals along the axial direction of the base pipe wall 11. Each group of rotating parts 20a includes at least one rotating member 20.

[0054] In the radial direction of the base tube 10, the diameter of the rotating part 20 is 0.05mm-0.2mm.

[0055] The inner circumferential wall of the base pipe wall 11 is provided with mounting grooves 111, the same number as the rotating parts 20a, forming a closed loop around the axis of the base pipe wall 11. All rotating components 20 in each group of rotating parts 20a are individually housed in a mounting groove 111 and arranged sequentially along the circumference of the base pipe wall 11. Each rotating component 20 can rotate relative to the base pipe wall 11 around its own axis. Each mounting groove 111 can be filled with rotating components 20, allowing all rotating components 20 to contact each other, or... Figure 11 As shown, it is not completely occupied by the rotating part 20.

[0056] If the mounting slot 111 is not completely occupied by the rotating component 20, in order to maintain the circumferential position of each rotating component 20, such as Figure 10 and Figure 11 As shown, multiple limiting blocks 113 are provided in the mounting groove 111, and independent receiving grooves are formed between adjacent limiting blocks 113. A rotating component 20 is disposed in a receiving groove, so that all rotating components 20 in the rotating part 20a are evenly arranged in the corresponding mounting groove 111, and the limiting blocks 113 maintain the circumferential distance between two adjacent rotating components 20 in the rotating part 20a.

[0057] To better constrain the rotating component 20, such as Figure 11 As shown, the bottom of the mounting groove 111 is set as a semi-circular groove.

[0058] In some embodiments, the radial fit clearance between the outer peripheral surface of the rotating member 20 and the bottom of the mounting groove 111 is 0.002mm-0.01mm.

[0059] In some embodiments, such as Figure 11 As shown, a limiting protrusion 112 is formed on the inner peripheral wall of the base pipe wall 11 between two adjacent mounting grooves 111. The limiting protrusion 112 maintains the axial distance between the rotating parts 20 in two adjacent rotating parts 20a.

[0060] Secondly, some embodiments of this application disclose a catheter 300, such as Figure 1 As shown, the catheter 300 includes an extension tube body 200 and a rotatable tip assembly 100 as described in any of the above embodiments. Figure 7 , Figure 8 and Figure 10 As shown, the distal end of the extension tube wall 210 of the extension tube body 200 is coaxially fixedly connected to the proximal end of the base tube wall 11 of the base tube body 10 of the rotatable head end assembly 100, so that the extension tube cavity 220 of the extension tube body 200 is coaxially connected to the base tube cavity 12 of the base tube body 10.

[0061] According to some alternative embodiments, the proximal end of the base tube 10 of the rotatable head end assembly 100 is integrally connected to the distal end of the extension tube 200.

[0062] The catheter 300 of this application does not fundamentally improve its internal structure, but still has a continuous axially penetrating lumen, which can be adapted to braided, cut, and self-expanding interventional stents, and is compatible with multiple specifications of products, thereby reducing the cost of device research and development and production.

[0063] Current catheter technology only establishes a pathway through its lumen to deliver the stent to the lesion site, but it cannot solve the problem of stent kinking and lumen loss that can occur when the stent passes through tortuous blood vessels.

[0064] In this embodiment, the distal portion of the catheter 300 employs a rotatable tip assembly, which reduces the incidence of stent kinking while delivering the stent 400 to the lesion site. Whether the torsion occurs during the delivery process through the tortuous vessel or as the stent 400 gradually opens from the distal tortuous vessel, the rotating component 20 of the catheter 300 adapts to the torsion direction of the proximal stent 400, thereby unwinding the proximal stent 400 and preventing further torsion, maintaining the patency of the internal lumen of the stent 400. This improves surgical efficiency and the success rate of the first attempt. It reduces the need for repeated retrieval and resetting actions to address stent kinking, effectively reducing the risk of stent dislodgement and deformation, thus improving the success rate of stent implantation and treatment safety. It effectively avoids post-stent remedial procedures, such as preventing balloon dilation and surgical stent removal after severe stent kinking, reducing post-operative complications caused by traditional remedial surgeries, and minimizing the risks of intimal tearing, bleeding, and stent retention.

[0065] It should be noted that, in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0066] Furthermore, it should be noted that the scope of the methods and apparatus in the embodiments of this application is not limited to performing functions in the order shown or discussed, but may also include performing functions substantially simultaneously or in the reverse order, depending on the functions involved. For example, the described methods may be performed in a different order than described, and various steps may be added, omitted, or combined. In addition, features described with reference to certain examples may be combined in other examples.

[0067] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application.

Claims

1. A rotatable tip assembly for a catheter (300), characterized in that: include: The base tube (10) includes a base tube wall (11) that extends axially from the distal end to the proximal end, and an axially penetrating base tube cavity (12) is formed on the inner side of the base tube wall (11). Rotating component (20) is axially positioned and connected to the inner circumferential wall of the base tube wall (11) and can rotate relative to the base tube wall (11). The rotating component (20) is used to radially contact and compress at least a portion of the axial section of the outer circumferential surface of the support inserted into the base tube cavity (12), so that the torsion support can transmit torque to the rotating component (20) to drive the rotating component (20) to rotate relative to the base tube wall (11), thereby gradually releasing the torque.

2. The rotatable head end assembly according to claim 1, characterized in that: The static friction coefficient between the rotating component (20) and the base pipe wall (11) is less than the static friction coefficient between the base pipe wall (11) and the outer peripheral surface of the support; and / or, the dynamic friction coefficient between the rotating component (20) and the base pipe wall (11) is less than the dynamic friction coefficient between the base pipe wall (11) and the outer peripheral surface of the support.

3. The rotatable head end assembly according to claim 1, characterized in that: The inner circumferential wall of the base pipe wall (11) is provided with an installation groove (111), and the rotating part (20) is rotatably disposed in the installation groove (111).

4. A rotatable head end assembly according to claim 3, characterized in that: The rotating component (20) is nested within the mounting groove (111); And / or, the rotating member (20) and the mounting groove (111) are magnetically attracted in the radial direction; And / or, the portion of the rotating member (20) that contacts the outer peripheral surface of the compression bracket (400) is flush with the inner peripheral surface of the base tube wall (11); And / or, there is an axial fit clearance between the rotating member (20) and the mounting groove (111); And / or, the rotating member (20) and the mounting groove (111) have a radial fit clearance of 0.002mm-0.01mm; And / or, the rotating component (20) is a structural component made of polymer, metal, or inorganic non-metallic material; And / or, at least a portion of the rotating member (20) is configured as a developing section (21) with developing properties. And / or, the axial length of the rotating member (20) is 0.05mm-10mm; And / or, the axial distance from the rotating member (20) to the distal port of the base cavity (12) is less than the axial length of the support (400).

5. A rotatable head end assembly according to claim 3 or 4, characterized in that: The rotating component (20) is configured as a cylindrical component coaxially arranged with the base pipe wall (11), and the rotating component (20) can rotate relative to the base pipe wall (11) around the axis of the base pipe wall (11).

6. A rotatable head end assembly according to claim 5, characterized in that: The peripheral wall of the rotating member (20) is provided with a groove for reducing the rigidity of the rotating member (20). The groove is formed on the outer peripheral surface and / or inner peripheral surface of the rotating member (20), and the groove depth is less than or equal to the peripheral wall thickness of the rotating member (20). And / or, the peripheral wall thickness of the rotating member (20) is 0.05mm-0.1mm; And / or, the inner circumferential surface of the rotating member (20) is provided with a hydrophilic coating or a hydrophobic coating; And / or, the outer peripheral surface of the rotating member (20) is set as a polished surface; And / or, the axial length of the rotating member (20) is between 0.5 mm and 3 mm; And / or, the axial length of the rotating member (20) is ≥1mm, at least a portion of the axial segment of the rotating member (20) is configured as a developing section (21), and the axial distance between the developing section (21) and the distal port of the base cavity (12) is 0.6mm-1.2mm; And / or, the frictional force between the rotating member (20) and the base pipe wall (11) is 0.0001N-0.02N.

7. A rotatable head end assembly according to claim 3 or 4, characterized in that: Multiple rotating components (20) are provided and are arranged in a ring; all rotating components (20) are coaxially arranged with the base pipe wall (11) and arranged sequentially at intervals along the axial direction; the rotating components (20) can rotate relative to the base pipe wall (11) around the axis of the base pipe wall (11).

8. A rotatable head end assembly according to claim 7, characterized in that: The ring width of the rotating component (20) is 0.02mm-0.08mm; And / or, the axial distance between two adjacent rotating parts (20) is 0.01mm-0.02mm; And / or, the number of rotating parts (20) is set to 50-500; And / or, each of the rotating parts (20) is individually disposed in one of the mounting slots (111), and a limiting protrusion (112) is formed between two adjacent mounting slots (111), the limiting protrusion (112) maintaining the axial distance between two adjacent rotating parts (20); And / or, the outer peripheral surface of the rotating member (20) is set as a polished surface; And / or, the inner circumferential surface of the rotating member (20) is provided with a hydrophilic coating or a hydrophobic coating.

9. A rotatable head end assembly according to claim 8, characterized in that: The rotating component (20) is provided in multiple ways and is configured as a ball or a roller; all the rotating components (20) are divided into multiple groups of rotating parts (20a) arranged sequentially and at intervals along the axial direction of the base pipe wall (11), and each group of rotating parts (20a) includes at least one of the rotating components (20). The mounting groove (111) is a closed loop around the axis of the base pipe wall (11); All the rotating parts (20) in each group of rotating parts (20a) are individually disposed in a mounting groove (111) and arranged sequentially along the circumference of the base pipe wall (11). The rotating parts (20) can rotate about their own axis relative to the base pipe wall (11).

10. A rotatable head end assembly according to claim 9, characterized in that: The bottom of the mounting groove (111) is set as a semi-circular groove; And / or, the diameter of the rotating member (20) is 0.05mm-0.2mm; And / or, a limiting protrusion (112) is formed between two adjacent mounting grooves (111), the limiting protrusion (112) maintaining the axial distance between the rotating members (20) in two adjacent rotating parts (20a); And / or, the rotating part (20a) is provided with a plurality of rotating members (20), all of the rotating members (20) in the rotating part (20a) are evenly arranged in the corresponding mounting groove (111), and a limiting block (113) is provided in the mounting groove (111), the limiting block (113) maintaining the circumferential distance between two adjacent rotating members (20) in the rotating part (20a).

11. A catheter (300), characterized in that: It includes an extension tube and a rotatable head end assembly (100) according to any one of claims 1-10, wherein the distal end of the extension tube is coaxially fixedly connected to the proximal end of the base tube (10) of the rotatable head end assembly (100).

Images