Interventional catheter

Abstract

The application provides an interventional catheter, comprising: a tube body having a pre-shaped curved head end; and a blood flow guiding power device comprising a framework and a cover; the framework comprises a plurality of support rods arranged along the circumference of the tube body; each support rod is slidably arranged in the side wall of the tube body; each support rod has an extended state and a retracted state; in the extended state, the distal end of each support rod extends from the side wall of the pre-shaped curved head end and extends axially towards the proximal end of the tube body; in the retracted state, the distal end of each support rod is withdrawn into the side wall of the pre-shaped curved head end; the proximal end of each support rod extends axially to the proximal end of the tube body; and the cover is connected to the distal end of at least part of the support rods to cover the hollow area between the distal ends of the at least part of the support rods. In this way, the pre-shaped curved head end of the interventional catheter can be actively deviated towards the target blood vessel, the success rate of intubation alignment is improved, and the risk of catheter dislocation and displacement is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an interventional catheter. Background Technology

[0002] Percutaneous coronary intervention (PCI) is a common coronary artery revascularization procedure, primarily using the radial or femoral artery as the entry point. Due to its minimal invasiveness and high success rate, radial PCI has become an important treatment for coronary artery disease. During PCI, a guiding catheter is used to create a minimally invasive access channel within the patient's body, providing pathways for subsequent treatment devices (such as guidewires, balloons, and stents) to open the blocked blood vessel. Therefore, the guiding catheter plays a crucial role, not only in creating the access channel and providing stable support, but also in the pre-shaped design of its tip. The tip of the guiding catheter is straightened after passing through the catheter sheath, but actively returns to its pre-shaped form after entering the aortic arch. The operator manipulates the guiding catheter to insert its tip into the patient's coronary ostium, achieving "coronary artery grafting"; and needs to adjust the proximal tip of the guiding catheter to ensure its axis is parallel to the direction of the coronary ostium, i.e., "coaxial." Therefore, the shape of the pre-shaped tip of the guide tube determines whether it can be successfully crowned and coaxially aligned to form a pathway for further treatment.

[0003] However, due to individual differences, the orientation of the coronary artery ostium, that is, the angle between the coronary artery and the aortic arch, varies considerably from person to person. For patients with unique anatomy of the coronary artery ostium, conventionally pre-shaped guiding catheters are often insufficient for successful coronary artery grafting, let alone providing stable support after grafting. In such cases, experienced physicians must perform prolonged attempts at grafting, or manually pre-shape the catheter externally based on the situation. This not only increases the surgeon's workload and operation time but also hinders postoperative recovery for the patient. Summary of the Invention

[0004] The purpose of this invention is to provide an interventional catheter that solves the problem that guiding catheters or other interventional catheters are difficult to successfully perform coronary artery grafting for patients with special coronary artery ostial anatomy, and cannot provide stable support after grafting.

[0005] To solve the above-mentioned technical problems, the present invention provides an interventional catheter, comprising:

[0006] The tube body has a pre-shaped bent end;

[0007] And a blood flow guiding power device, the blood flow guiding power device including a frame and a cover; the frame including a plurality of support rods arranged circumferentially along the tube body; each of the support rods is slidably inserted into the side wall of the tube body;

[0008] Each of the support rods has an extended state and a retracted state; in the extended state, the distal end of the support rod extends from the side wall of the pre-shaped bending head end and axially extends toward the proximal end of the tube body; in the retracted state, the distal end of the support rod is retracted into the side wall of the pre-shaped bending head end; the proximal end of each support rod extends axially to the proximal end of the tube body.

[0009] The covering is connected to at least a portion of the distal ends of the support rods to cover the hollow area between the distal ends of at least a portion of the support rods.

[0010] Optionally, the cover is an annular structure and is connected to the distal ends of all the support rods to cover the annular hollow area formed by the circumferential enclosure of the distal ends of all the support rods, and correspondingly exposes the edge area of ​​the annular hollow area near the inner and / or outer periphery.

[0011] Optionally, when the support rods are extended, their distal ends together form an umbrella-shaped structure with a concave cavity; the covering is connected and disposed on the inner and / or outer side of the umbrella-shaped structure.

[0012] Optionally, each of the support rods, in its extended state, includes a straight section and an arc section connected sequentially from the proximal end to the distal end; the straight section extends radially along the tube body; the arc section expands radially outward and extends axially toward the proximal end of the tube body.

[0013] Optionally, the covering is entirely connected to the straight section, or a portion of the covering is connected to the straight section and another portion is connected to the arc section, and the covering avoids the position where the arc section contacts the target blood vessel wall.

[0014] Optionally, the sidewall of the pre-shaped bending head end is provided with a plurality of through side holes; the distal ends of each of the support rods are respectively inserted into the side holes; the outer surface of the sidewall of the pre-shaped bending head end is provided with a storage groove, which is used to accommodate the folded cover in the folded state.

[0015] Optionally, the outer surface of the side wall of the pre-shaped bending head end is provided with an annular mounting groove; a developing ring is provided in the annular mounting groove; the developing ring is provided with through holes corresponding to each of the side holes; the developing ring is also provided with a receiving groove that communicates with the through holes.

[0016] Optionally, the developing ring is located at the distal end of the pre-shaped bent head and close to the tip; the receiving groove is an annular groove and communicates with all the through holes.

[0017] Optionally, the tube body includes an inner layer, a middle layer, and an outer layer arranged radially from the inside to the outside; the inner layer and the outer layer are both made of polymer materials; the middle layer is made of metal materials; wherein each of the support rods is slidably inserted into the sidewall of the inner layer; and the developing ring is nested in the outer layer.

[0018] Optionally, the tube body includes a pre-shaped bent head end, a support section, and a pushing section connected sequentially from the distal end to the proximal end; the stiffness of the pushing section is greater than the stiffness of the support section; the stiffness of the support section is greater than the stiffness of the pre-shaped bent head end; the pre-shaped bent head end includes a tip head, a coaxial section, and a bending-resistant section connected sequentially from the distal end to the proximal end; the stiffness of the bending-resistant section is greater than the stiffness of the coaxial section; the tip head bends inward relative to the coaxial section towards the pushing section, and / or the curvature of the pre-shaped bent head end gradually decreases from the proximal end to the distal end.

[0019] In summary, the interventional catheter provided by the present invention includes: a catheter body having a pre-shaped curved tip; and a blood flow guiding device, the blood flow guiding device including a skeleton and a cover; the skeleton including a plurality of support rods arranged circumferentially spaced along the catheter body; each support rod is slidably inserted into the side wall of the catheter body; each support rod has an extended state and a retracted state; in the extended state, the distal end of the support rod extends from the side wall of the pre-shaped curved tip and axially extends towards the proximal end of the catheter body; in the retracted state, the distal end of the support rod retracts into the side wall of the pre-shaped curved tip; the proximal end of each support rod axially extends to the proximal end of the catheter body; the cover is connected to at least a portion of the distal ends of the support rods to cover the hollow area between at least a portion of the distal ends of the support rods.

[0020] This configuration allows for both passive cannulation and active cannulation. Passive cannulation positioning of the pre-shaped curved tip can be achieved by manipulating the interventional catheter. Alternatively, when normal cannulation positioning is difficult, the distal ends of the support rods of the vascular guidance power device can be extended to form a blood flow guiding power umbrella. Utilizing the force of blood flow on the covering, the pre-shaped curved tip is actively driven towards the target vessel to complete cannulation positioning. This allows for both passive and active cannulation, effectively improving the success rate of cannulation procedures. Furthermore, after cannulation positioning, the distal end of the interventional catheter is stably anchored within the target vessel under the support of the support rods, effectively reducing the risk of catheter displacement or detachment during the procedure. This structure is also adaptable to both conventional and anatomically abnormal target vessels, offering strong compatibility, wide applicability, and greater flexibility and convenience in use. Attached Figure Description

[0021] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention.

[0022] Figure 1 This is a schematic diagram showing that the openings of both coronary arteries are perpendicular to the aortic arch.

[0023] Figure 2 This is a schematic diagram showing the opening of the left coronary artery facing upwards.

[0024] Figure 3 This is a schematic diagram showing the left coronary artery opening downwards.

[0025] Figure 4 This is a diagram illustrating the difficulty in achieving coronalization at the tip of the catheter.

[0026] Figure 5 This is a schematic diagram of the entire interventional catheter according to an embodiment of the present invention, wherein the blood flow guiding power device is retracted inside the catheter body and is not exposed.

[0027] Figure 6 This is a schematic diagram of the distal end of the interventional catheter successfully crowned and kept coaxial according to an embodiment of the present invention.

[0028] Figure 7 This is a schematic diagram of the tube body according to an embodiment of the present invention.

[0029] Figure 8 This is a schematic diagram of an embodiment of the present invention, in which multiple support rods are slidably assembled inside the tube body, and the distal end of each support rod can extend outward from the distal side wall of the tube body.

[0030] Figure 9 yes Figure 8 A schematic diagram showing how the distal ends of each support rod extend outward from the distal side wall of the tube and then bend back to form the shape.

[0031] Figure 10 This is a schematic diagram of an embodiment of the present invention, showing that the distal ends of each support rod extend out and fully open to form an umbrella-shaped structure.

[0032] In the attached diagram: 10-Coronary artery ostium, 20-Routine guiding catheter, 30-Interventional catheter, 31-Proximal connector, 32-Stress tube, 33-Contrast ring, 331-Through hole, 40-Target vessel, 100-Catheter body, 101-Catheter outer surface, 102-Side hole, 103-Receiving groove, 110-Pre-shaped curved tip, 111-Tip tip, 112-Coaxial segment, 113-Anti-bending segment, 120-Support segment, 130-Push segment, 200-Flow guiding device, 201-Marginal area, 202-Concave cavity, 210-Skeleton, 211-Support rod, 220-Covering material. Detailed Implementation

[0033] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0034] As used herein, the singular forms “a,” “an,” “one,” and “the” include plural objects; the term “or” is generally used to include the meaning of “and / or”; the term “a number” is generally used to include the meaning of “at least one”; the term “at least two” is generally used to include the meaning of “two or more”; furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature; “one end” and “the other end,” and “proximal end” and “distal end” generally refer to two corresponding parts, which include not only the endpoints. The terms “proximal end” and “distal end” are defined herein with respect to an interventional catheter having an end for insertion into the human body and a control end extending outside the body. The term “proximal end” refers to the position closer to the control end extending outside the body of the interventional catheter, and the term “distal end” refers to the position closer to the end of the interventional catheter inserted into the human body and therefore further away from the control end of the interventional catheter. Optionally, in applications involving manual or hand-operated manipulation, the terms "proximal" and "distal" are defined herein in relation to the operator, such as a surgeon or clinician. The term "proximal" refers to a position closer to the operator, and the term "distal" refers to a position closer to the patient's affected area and therefore further away from the operator. Furthermore, as used in this invention, terms such as "installed," "connected," "attached," and "set" of one element on another should be interpreted broadly, generally indicating only a connection, coupling, engagement, or transmission relationship between the two elements, which can be direct or indirect through an intermediate element. This connection, coupling, engagement, or transmission should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. Additionally, directional terms such as above, below, up, down, upward, downward, left, right, etc., are used relative to exemplary embodiments as shown in the figures, with upward or upper directions pointing towards the top of the corresponding figure, and downward or lower directions pointing towards the bottom of the corresponding figure.

[0035] In this application, "axial" refers to the direction parallel to the longitudinal axis of the interventional catheter; "radial" refers to the direction perpendicular to the longitudinal axis and along the radius or diameter; and "circumferential" refers to the annular direction around the longitudinal axis and along the circumferential tangent.

[0036] like Figure 1 As shown, for the left coronary artery (LCA), the conventional coronary ostium 10 is basically perpendicular to the aortic arch AA; as... Figure 2and Figure 3 As shown, the abnormal coronary artery ostium 10 is positioned facing upwards or downwards. For example... Figure 4 As shown, when the coronary artery ostium 10 has a unique shape, the pre-shaped tip of the conventional guiding catheter 20 cannot meet the requirements, making it difficult to successfully complete the coronary artery grafting. In this case, the surgeon needs to repeatedly adjust the guiding catheter 20 to potentially complete the grafting, and may even need to manually reshape the tip of the guiding catheter 20 externally before attempting grafting again. This significantly increases the surgeon's workload, prolongs the operation time, and is also detrimental to the patient's postoperative recovery.

[0037] More specifically, the conventional guiding catheter 20 has a fixed tip configuration. For patients with special coronary ostium 10 conditions, even with repeated manipulation by the operator, the guiding catheter 20 still struggles to achieve coronary artery grafting. Furthermore, due to the limited tip shape, even if the guiding catheter 20 is forcibly manipulated to achieve coronary artery grafting, it is difficult to maintain coaxiality with the coronary ostium 10, failing to provide stable support for subsequent treatment devices. In addition, the conventional guiding catheter 20 lacks the ability to autonomously graft; if the angle of the coronary ostium 10 does not match the pre-shaped tip, the guiding catheter 20 will malfunction and become unusable.

[0038] To solve the above-mentioned technical problems, the present invention provides an interventional catheter, which, with the support of a pre-shaped tip, can be manipulated to achieve passive insertion and alignment, and can also achieve active insertion and alignment through the unique structure of the interventional catheter itself, and can provide stable support after insertion and alignment.

[0039] The interventional catheter of this invention is primarily intended for scenarios requiring placement via this catheter, but is not limited to coronary interventional procedures, i.e., not limited to cannulation alignment at the coronary ostium. Exemplarily, the interventional catheter is a guiding catheter or a microcatheter. The guiding catheter or microcatheter is used to access a target site within the blood vessel and introduce a therapeutic device at the target site. The target site may be a portion of the coronary artery, for example, the ostium of the left coronary artery. Various therapeutic devices, such as guidewires, balloons, stents, or other interventional devices, can be introduced into the patient's blood vessel and advanced to the target site. The therapeutic device can be housed within the lumen of the interventional catheter or introduced after the interventional catheter has been correctly positioned at the target site.

[0040] refer to Figures 5 to 10 As shown, this embodiment of the invention provides an interventional catheter 30, including a tube body 100, which is the main part of the entire interventional catheter 30. The tube body 100 is a hollow, slender tubular structure, allowing therapeutic instruments to pass through its inner lumen. The tube body 100 also has a pre-shaped curved tip 110, which is shaped to a certain bending angle to match the target blood vessel 40. For example, as... Figure 6As shown, the target vessel 40 is the left coronary artery (LCA). At this time, the pre-shaped curved tip 110 can match the angle of the coronary artery opening 10 to help the interventional catheter 30 be inserted and positioned.

[0041] Continue to refer to Figure 6 As shown, the interventional catheter 30 of the present invention also includes a blood flow guiding power device 200. This blood flow guiding power device 200 can assist the interventional catheter 30 in autonomous insertion based on blood flow dynamics. The structure of the blood flow guiding power device 200 can be found in [reference needed]. Figures 8 to 10 As shown.

[0042] The blood flow guiding power device 200 includes a frame 210 and a cover 220. The frame 210 includes a plurality of support rods 211 arranged circumferentially along the tube body 100. Each support rod 211 is slidably inserted into the side wall of the tube body 100, i.e., accommodated within the wall thickness of the tube body 100. Each support rod 211 has an extended state and a retracted state. In the extended state, the distal end of the support rod 211 extends from the side wall of the pre-shaped curved end 110 and extends axially toward the proximal end of the tube body 100. In the retracted state, the distal end of the support rod 211 retracts into the side wall of the pre-shaped curved end 110, and the proximal end of each support rod 211 extends axially to the proximal end of the tube body 100.

[0043] In the extended state, the distal ends of all support rods 211 expand radially outward and contact the lumen wall of the target blood vessel 40, providing stable support for the distal end of the interventional catheter 30. This additional support helps reduce the risk of the interventional catheter 30 dislodging from the target blood vessel 40 and enhances the stability of the interventional catheter 30 when the therapeutic device is advanced through it.

[0044] The frame 210 may include any suitable number of support rods 211. For example... Figure 10 As shown, the frame 210 may include eight support rods 211. In other examples, the frame 210 may include fewer support rods 211, such as three to seven support rods 211, or more support rods 211, such as nine or more. The support rods 211 may have any suitable construction, such as, but not limited to, flat rods or round rods. The support rods 211 may be made of any suitable elastic material, hyperelastic material, or shape memory material, such as, but not limited to, nickel-titanium alloy or stainless steel, or combinations thereof.

[0045] Each support rod 211 is axially slidably engaged with the tube body 100, allowing the support rod 211 to move axially along the interventional catheter 30. Therefore, the sidewall of the tube body 100 is provided with an axially extending channel that allows the support rod 211 to pass through, with each axially extending channel corresponding to a support rod 211. Each support rod 211 is independently configured; under normal conditions, the support rod 211 neither protrudes from the catheter lumen nor is exposed on the outer surface 101 of the catheter; it is only exposed on the outer surface 101 of the catheter after the distal end of the support rod 211 extends out of the tube body 100. Therefore, each support rod 211 does not affect the pushing or retraction process of the interventional catheter 30.

[0046] In addition, the cover 220 is connected and disposed at the distal end of at least a portion of the support rods 211, covering the hollow area between the distal ends of at least a portion of the support rods 211. The hollow area here refers to the gap area formed by the circumferential arrangement of the support rods 211. For example... Figure 10 As shown, all the support rods 211 are arranged circumferentially at their distal ends to form an annular hollow area, and this annular hollow area is only formed after the distal ends of the support rods 211 extend from the side wall of the pre-shaped bent head end 110. The inner circumferential boundary of this annular hollow area corresponds to the outer surface 101 of the conduit, that is, the outer surface of the tube body 100. Generally, the annular hollow area is circular.

[0047] This invention allows for the selection of single or multiple sets of support rods 211 for membrane-covered connections according to actual needs. The covering 220 can be placed only between the distal ends of some support rods 211, partially covering the hollowed-out area; alternatively, the covering 200 can be placed completely between the distal ends of all support rods 211, fully covering the hollowed-out area. Through these partial or full coverage arrangements, the blood flow impact area and guiding force can be flexibly adjusted to adapt to the adaptive guiding requirements of different blood vessel diameters and anatomical conditions.

[0048] It should be understood that the cover 220 is a flow-blocking component that obstructs blood flow, specifically a membrane, fabric, or similar material. The cover 220 can be made of highly elastic and flexible polymer materials, such as natural latex, silicone, or TPU elastomers, possessing excellent elasticity and deformation recovery capabilities. It can fold and unfold with the retraction and extension of the support rod 211, balancing structural flexibility and pressure resistance. The cover 220 is normally retracted into the side wall of the pre-shaped curved end 110 and only opens when pulled by the support rod 211. Figure 10 As shown, once the support rod 211 is fully extended and conforms to the target blood vessel 40 to form support, the cover 220 is also fully opened. The cover 200 can be attached to the support rod 211 by adhesive and / or suturing.

[0049] In actual use, the blood flow guiding device 200 must first be retracted so that the distal ends of each support rod 211 are properly housed within the side wall of the pre-shaped curved tip 110. Then, the interventional catheter 30 is delivered. After delivery, the blood flow guiding device 200 is opened. At this time, the proximal ends of each support rod 211 are manipulated to push the distal ends of the support rods 211 out from the side wall of the pre-shaped curved tip 110. After the distal ends of each support rod 211 extend, they can expand radially outward using their own elastic force and bend back towards the proximal end of the tube body 100 to protect the blood vessel. At the same time, with the help of the force of blood flow on the covering 220, the pre-shaped curved tip 110 is actively driven to deviate towards the target blood vessel 40 to complete the alignment until it is successfully inserted into the target blood vessel 40. After the surgery is completed, the proximal ends of each support rod 211 are manipulated in the same way as above, and the distal ends of each support rod 211 are retracted into the side wall of the pre-shaped curved head 110; finally, the interventional catheter 30 is retracted.

[0050] Understandably, the extension position of each support rod 211 from the pre-shaped curved tip 110 determines the angle that the distal end of the catheter can deflect; the farther the support rod 211 extends, the greater the deflection angle. Generally, the extension position of each support rod 211 is set at the distal end of the pre-shaped curved tip 110, which can be close to the tip 111 or slightly away from the tip 111, as long as it is not set on top of the tip 111. The tip 111 is located at the distal end of the entire interventional catheter 30, which can reduce damage to the blood vessel.

[0051] The following example illustrates coronary artery cannulation alignment. (Reference) Figure 6As shown, this depicts the state where the interventional catheter 30 has been crowned and supported after the flow-directing device 200 is activated. Specifically, the pre-shaped curved tip 110 of the interventional catheter 30 enters the ascending aorta of the aortic arch AA. After returning to its pre-shaped form, it can normally be passively inserted into the coronary ostium 10 under the operator's manipulation, successfully completing the crowning process. If crowning becomes difficult, the flow-directing device 200 can be manipulated proximally to extend the distal ends of each support rod 211, opening the cover 220 and constructing a flow-directing umbrella. Subsequently, the blood flow impacts the cover 220, actively guiding the pre-shaped curved tip 11 towards the coronary ostium 10, allowing the interventional catheter 30 to actively complete the crowning process and anchor in the coronary ostium 10 under the action of the support rods 211. This assists the operator in establishing access more quickly during procedures such as PCI. Therefore, the flow-directing device 200 also protects the blood vessel and provides sufficient support for the interventional catheter 30, ensuring its stable anchoring in the coronary ostium 10. Furthermore, when other therapeutic devices such as guidewires, stents, or balloons pass through the lumen of the interventional catheter 30, the catheter 30 will not dislodge due to friction or the reaction force when penetrating the lesion, and will remain in its predetermined position, thus enhancing its ability to actively support other therapeutic devices. It is worth noting that the flow diversion device 200 can be activated to provide stable support after passive coroning is completed, or it can be activated before coroning is completed to provide stable support after active coroning is completed.

[0052] Therefore, the operator can directly manipulate the interventional catheter 30 to complete routine passive cannulation, or utilize the blood flow guiding power device 200 to achieve active guided cannulation using the blood flow impact effect. This dual operating mode effectively improves the overall success rate and positioning accuracy of the cannulation operation. Simultaneously, with the support of the various support rods 211, the distal end of the interventional catheter 30 can be stably anchored within the target vessel 40, effectively reducing the risk of catheter displacement or detachment from the target vessel 40 during the procedure, and improving intraoperative stability and surgical safety. Furthermore, this interventional catheter 30 is compatible with both conventional and anatomically abnormal target vessels, exhibiting strong adaptability and a wide range of clinical applications.

[0053] like Figure 5As shown, to improve the support and passage performance of the interventional catheter 30, the different segments of the catheter body 100 have different stiffnesses. Specifically, the stiffness of the catheter body 100 gradually decreases axially from the proximal end to the distal end, resulting in higher stiffness at the proximal end and lower stiffness at the distal end. This increases its flexibility while maintaining support. In this embodiment, the catheter body 100 may include a pre-shaped curved tip 110, a support segment 120, and a pusher segment 130 connected sequentially from the distal end to the proximal end. It should be understood that the pre-shaped curved tip 110, the support segment 120, and the pusher segment 130 are used to describe different regions along the length of the interventional catheter 30 and can have any suitable length. Therefore, the different stiffnesses of the catheter body 100 ensure both the overall support of the interventional catheter 30 and its passage performance, allowing it to smoothly pass through complex bends in the blood vessel and reducing damage to the vessel wall.

[0054] The push section 130 is operated and pushed by the operator, and its stiffness is greater than that of the support section 120, ensuring good anti-kink and anti-torsion properties of the interventional catheter 30 when advanced in the blood vessel. The stiffness of the support section 120 is greater than that of the pre-shaped curved tip 110, providing sufficient support for the catheter body 100 and ensuring the support performance of the interventional catheter 30. Preferably, the stiffness of the pre-shaped curved tip 110 gradually increases from the distal to the proximal end, allowing the interventional catheter 30 to pass smoothly through the curved parts in the blood vessel, ensuring the passability of the interventional catheter 30.

[0055] Optionally, the pre-shaped bent tip 110 includes a tip 111, a coaxial section 112, and a bending-resistant section 113 connected sequentially from distal to proximal. The stiffness of the bending-resistant section 113 is greater than that of the coaxial section 112. The bending-resistant section 113 is connected to the support section 120. The coaxial section 112 and the tip 111 can be coaxially aligned. The coaxial section 112 can be bent inward relative to the bending-resistant section 113 towards the pushing section 130 for better cannulation alignment. However, in other embodiments, the tip 111 can also be bent inward relative to the coaxial section 112 towards the pushing section 130, i.e., the tip 111 and the coaxial section 112 are not coaxially aligned.

[0056] Preferably, the curvature of the pre-shaped curved tip 110 decreases sequentially from proximal to distal. The main purpose of this sequential change in curvature is to make it easier for the tip of the interventional catheter 30 to return to its pre-shaped shape after entering the blood vessel, and to enter the target blood vessel 40 and conform to the vessel wall.

[0057] Return to reference Figure 5As shown, the interventional catheter 30 of the present invention may include a proximal connector 31, and the proximal end of the catheter body 100 may extend into the proximal connector 31. The proximal connector 31 may include the proximal end of the catheter body 100, forming part of the proximal portion of the interventional catheter 20. In this embodiment, the interventional catheter 30 may further include a stress tube 32, which is fitted at the connection position between the proximal end of the catheter body 100 and the proximal connector 31, and its main function is to provide proximal anti-bending buffer. Optionally, the stress tube 32 is connected to the proximal end of each support rod 211 to control the axial movement of the support rod 211. The stress tube 32 may also lock the proximal end of each support rod 211 to restrict the movement of the support rod 211.

[0058] To better control the deflection of the pre-shaped curved tip 110 toward the target blood vessel 40, in a preferred embodiment, such as Figure 10 As shown, the cover 200 has an annular structure and is connected to the distal ends of all the support rods 211 to cover the annular hollow area formed by the circumferential enclosure of the distal ends of all the support rods 211, and correspondingly exposes the edge area 201 of the annular hollow area near the inner and / or outer periphery. With this configuration, the cover 220 can form a complete and continuous blood guiding surface, which can uniformly receive the impact of blood flow in 360° direction, effectively improving the effect of active alignment and autonomous cannulation.

[0059] Figure 10 The diagram illustrates the situation when the cover 220 is fully open. The cover 200 avoids contact between the distal ends of the support rods 211 and the lumen wall of the target blood vessel 40, providing a blood flow channel and allowing normal blood flow. In this embodiment, the cover 200 corresponds to the exposed annular perforated area near the outer periphery of the edge region 201, which is a blank annular gap. It should be noted that the inner side of the cover 220 can either be fitted flush with the outer surface 101 of the catheter, achieving a gapless seal and enhancing blood flow guidance; or the inner side of the cover 220 can have a pre-existing gap with the outer surface 101 of the catheter, forming a blood flow channel.

[0060] Figure 9 The diagram also demonstrates the state where the distal ends of each support rod 211 are fully extended from the tube body 100. In this extended state, the distal ends of each support rod 211 collectively form an umbrella-shaped structure with a concave cavity 202. A covering 220 is connected and disposed on the inner and / or outer side of the umbrella-shaped structure. Here, the inner side refers to the side containing the concave cavity 202, and the outer side is the side facing away from the concave cavity 202. Thus, the blood flow impacting the inner side of the umbrella-shaped structure, and the continuous thrust of the blood flow acting on the concave surface, can actively deflect the pre-shaped curved tip 110 towards the target vessel 40 until successful cannulation.

[0061] In this invention, the covering 220 is preferentially arranged on the inner side of the umbrella-shaped structure, that is, on one side of the concave cavity 202. After the blood flows into the concave cavity 202, it acts directly on the covering 220. The impact of the blood flow generates a lateral torque, driving the pre-shaped curved tip 110 to deflect toward the target lumen 40, thus completing autonomous cannulation. At the same time, the covering 220 does not contact the blood vessel wall and does not block the blood vessel.

[0062] Preferably, each support rod 211, in its extended state, includes a straight section 211A and an arcuate section 211B connected sequentially from proximal to distal. The straight section 211A extends radially along the tube body 100; the arcuate section 211B expands radially outward and extends axially toward the proximal end of the tube body 100. The straight section 211A partially extends out of the tube body 100, positioned substantially perpendicular to the axial direction of the target blood vessel 40, and does not contact the target blood vessel 40; while the arcuate section 211B conforms to and contacts the target blood vessel 40, and the end of the arcuate section 211B tapers inward toward the side away from the target blood vessel 40, without directly piercing the blood vessel wall, thereby protecting the target blood vessel 40. The arcuate section 211B has self-rebound characteristics; it can be pre-shaped and automatically bends back into shape after extension; in the retracted state, the arcuate section 211B is straightened and housed within the side wall.

[0063] In some embodiments, the cover 220 may be entirely connected to the straight section 211A; in other embodiments, a portion of the cover 220 is connected to the straight section 211A and another portion is connected to the arc section 211B, and the cover 220 avoids the position where the arc section 211B contacts the target blood vessel 40, that is, the radial maximum point of the arc section 211B.

[0064] Finally, the distal ends of each support rod 211 extend to a certain length and form support with the blood vessel wall, so that the interventional catheter 30 is anchored in the target blood vessel 40, forming support while avoiding excessive insertion that could cause blood vessel damage.

[0065] refer to Figure 8 As shown, to avoid the support rod 211, the side wall of the pre-shaped bent end 110 is provided with multiple through side holes 102; the distal ends of each support rod 211 are respectively inserted into the side holes 102. (Reference) Figure 7 As shown, a storage groove 103 is provided on the outer surface of the side wall of the pre-shaped bending end 110. The storage groove 103 is used to accommodate the folded cover 220 in the folded state. In this embodiment, a side hole 102 and a storage groove 103 can be opened at the position of the pre-shaped bending end 110 corresponding to the position of the anti-bending section 113 or the coaxial section 112. The storage groove 103 can be directly or indirectly provided on the tube body 100.

[0066] Continue to refer to Figure 7As shown, the outer surface of the sidewall of the pre-shaped curved tip 110 is provided with an annular mounting groove; a contrast-enhancing ring 33 is disposed within this annular mounting groove. Preferably, the contrast-enhancing ring 33 is disposed on the pre-shaped curved tip 110 near the tip 111, that is, the contrast-enhancing ring 33 is disposed at the distal end of the pre-shaped curved tip 110 and close to the tip 111. The contrast-enhancing ring 33 can be nested within the outer surface of the coaxial segment 112 or the anti-bending segment 113. The contrast-enhancing ring 33 is used for intraoperative image visualization positioning, assisting the pre-shaped curved tip 110 in aligning with the target vessel 40 to complete the cannulation operation, and monitoring the working position of the distal end of the catheter in real time.

[0067] In this embodiment, the developing ring 33 has through holes 331 corresponding to each side hole 102; the developing ring 33 also has a receiving groove 103 communicating with the through holes 331. The receiving groove 103 may or may not penetrate the developing ring 33 radially. Therefore, the support rod 211 needs to extend or retract through the developing ring 33. For example, the developing ring 33 has eight through holes 331 for eight support rods 211 to pass through. Thus, when the cover 220 is not opened, it is pre-embedded and stored in the receiving groove 103 of the developing ring 33 in a small volume form; as the support rod 211 gradually extends outward, the cover 220 can simultaneously and slowly extend out of the receiving groove 103 and gradually unfold.

[0068] Furthermore, when the cover 220 is an annular structure, the corresponding storage groove 103 is an annular groove and is connected to all the through holes 331.

[0069] Preferably, the tube body 100 has a multi-layer structure, such as two, three, or more layers. When the tube body 100 has a multi-layer structure, it is made of a composite of polymer materials and metal materials to balance flexibility, support, and lubrication of the inner and outer walls.

[0070] like Figure 8 and Figure 9 As shown, in this embodiment, the tube body 100 has a three-layer structure, including an inner layer 1001, a middle layer 1002, and an outer layer 1003 arranged radially from the inside to the outside; the inner layer 1001 and the outer layer 1003 are both made of polymer materials, while the middle layer 1002 is made of metal materials. Preferably, each support rod 211 is slidably inserted into the sidewall of the inner layer 1001; and the developing ring 33 is nested in the outer layer 1003, and is at the same level as the outer layer 1003.

[0071] The inner layer 1001 has a smooth inner wall, which reduces the frictional resistance of the therapeutic instrument as it travels through the lumen of the interventional catheter 30. The outer layer 1003 is used to contact the inner wall of the blood vessel, and therefore needs to be soft and smooth to reduce abrasion and irritation to the inner wall of the blood vessel, while improving overall flexibility to facilitate the catheter's passage through the blood vessel to the coronary artery ostium. Optionally, the inner layer 1001 and the outer layer 1003 may be selected from one or a combination of Nylon, Pebax, PTFE, PP, PA, PE, HDPE, BaSO4, and BiOCl.

[0072] The intermediate layer 1002 serves as a reinforcing layer, enhancing the overall torsional strength and pushing performance of the tube body 100. Optionally, the intermediate layer 1002 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, or other metallic materials. The intermediate layer 1002 is preferably a braided layer. In one example, the intermediate layer 1002 is composed of 8 or 16 cross-woven metal wires, which may be round wires, flat wires, or a combination of round and flat wires, with a braiding density ranging from 35 PPI to 100 PPI.

[0073] As mentioned above, the stiffness of the tube body 100 can vary in a gradient along the axial direction. In practice, the stiffness of the tube body 100 can be varied in various ways, such as adjusting the hardness of the polymer material of the outer layer 1003 and changing the braiding density of the middle layer 1002. In addition, other methods can be used to change the overall stiffness of the tube body 100, such as the braiding filament diameter, braiding angle, and tube wall thickness. This application does not limit these methods.

[0074] In summary, the interventional catheter 30 provided by the present invention includes: a catheter body 100, the catheter body 100 having a pre-shaped curved tip 110; and a blood flow guiding device 200, the blood flow guiding device 200 including a frame 210 and a cover 220; the frame 210 includes a plurality of support rods 211 arranged circumferentially at intervals along the catheter body 100; each support rod 211 is slidably inserted into the side wall of the catheter body 100; each support rod 211 has an extended state and a retracted state. In the extended state, the distal end of the support rod 211 extends from the side wall of the pre-shaped curved tip 110 and axially extends towards the proximal end of the tube body 100; in the retracted state, the distal end of the support rod 211 retracts into the side wall of the pre-shaped curved tip 110; the proximal end of each support rod 211 axially extends to the proximal end of the tube body 100; the cover 220 is connected and disposed at least partially at the distal end of the support rod 211 to cover the hollow area between the distal ends of at least partially the support rod 211. With this configuration, during the procedure, supported by the shape of the pre-shaped curved tip 110 and based on the blood flow guiding power device 200, the distal end of the interventional catheter 30 can be autonomously guided and smoothly inserted into the target blood vessel 40, effectively improving the success rate of catheterization. Simultaneously, supported by each support rod 211, the distal end of the catheter can be stably anchored within the target blood vessel 40, effectively reducing the risk of catheter displacement or detachment from the target blood vessel during the procedure. Therefore, it can also be adapted to target blood vessels with both conventional and abnormal anatomical structures, making it suitable for a wider range of applications.

[0075] It should be noted that the above embodiments can be combined with each other. The above description is only a description of preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. An interventional catheter, characterized in that, include: The tube body has a pre-shaped bent end; And a blood flow guiding power device, the blood flow guiding power device including a frame and a cover; the frame including a plurality of support rods arranged circumferentially along the tube body; each of the support rods is slidably inserted into the side wall of the tube body; Each of the support rods has an extended state and a retracted state; in the extended state, the distal end of the support rod extends from the side wall of the pre-shaped bending head end and axially extends toward the proximal end of the tube body; in the retracted state, the distal end of the support rod is retracted into the side wall of the pre-shaped bending head end; the proximal end of each support rod extends axially to the proximal end of the tube body. The covering is connected to at least a portion of the distal ends of the support rods to cover the hollow area between the distal ends of at least a portion of the support rods.

2. The interventional catheter according to claim 1, characterized in that, The covering is a ring structure and is connected to the far ends of all the support rods to cover the annular hollow area formed by the circumferential enclosure of the far ends of all the support rods, and correspondingly exposes the edge area of ​​the annular hollow area near the inner and / or outer periphery.

3. The interventional catheter according to claim 1 or 2, characterized in that, When the support rods are extended, their distal ends together form an umbrella-shaped structure with a concave cavity; the covering is connected and disposed on the inner and / or outer side of the umbrella-shaped structure.

4. The interventional catheter according to claim 3, characterized in that, In the extended state, each of the support rods includes a straight section and an arc section connected sequentially from the proximal end to the distal end; the straight section extends radially along the tube body; the arc section expands radially outward and extends axially toward the proximal end of the tube body.

5. The interventional catheter according to claim 4, characterized in that, The covering is entirely connected to the straight section, or a portion of the covering is connected to the straight section and another portion is connected to the arc section, and the covering avoids the position where the arc section contacts the target blood vessel wall.

6. The interventional catheter according to claim 1 or 2, characterized in that, The pre-shaped bending head end has multiple through-holes on its side wall; the distal ends of each support rod are inserted into the side holes; the outer surface of the side wall of the pre-shaped bending head end has a storage groove for accommodating the folded cover in the folded state.

7. The interventional catheter according to claim 6, characterized in that, The outer surface of the side wall of the pre-shaped bending head end is provided with an annular mounting groove; a developing ring is provided in the annular mounting groove; the developing ring is provided with through holes corresponding to each of the side holes; the developing ring is also provided with a receiving groove that communicates with the through holes.

8. The interventional catheter according to claim 7, characterized in that, The developing ring is located at the distal end of the pre-shaped bent head and close to the tip; the receiving groove is an annular groove and is connected to all the through holes.

9. The interventional catheter according to claim 7, characterized in that, The tube body includes an inner layer, a middle layer, and an outer layer arranged radially from the inside to the outside; the inner layer and the outer layer are both made of polymer materials; the middle layer is made of metal materials; wherein each of the support rods is slidably inserted into the sidewall of the inner layer; and the developing ring is nested in the outer layer.

10. The interventional catheter according to claim 1 or 2, characterized in that, The tube body includes a pre-shaped bent head end, a support section, and a pushing section connected sequentially from the distal end to the proximal end; the stiffness of the pushing section is greater than the stiffness of the support section; the stiffness of the support section is greater than the stiffness of the pre-shaped bent head end; the pre-shaped bent head end includes a tip head, a coaxial section, and a bending-resistant section connected sequentially from the distal end to the proximal end; the stiffness of the bending-resistant section is greater than the stiffness of the coaxial section; the tip head is bent inward relative to the coaxial section towards the pushing section, and / or the curvature of the pre-shaped bent head end decreases sequentially from the proximal end to the distal end.

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