Interventional catheter devices

Abstract

The present invention relates to an interventional catheter device, which can prevent the tissues passed by from being damaged when the interventional catheter device is placed in the body through a flexible sleeve, and can also keep the interventional catheter at the intervention target point, thereby realizing a safe, accurate, efficient and easy-to-operate interventional surgery.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an interventional catheter device. Background Art

[0002] The following is a description of the background technologies related to the present invention, but these descriptions do not necessarily constitute the prior art of the present invention.

[0003] Interventional Radiology is a marginal discipline that has developed rapidly in the late 1970s. It is a series of technologies that use catheters, guidewires and other equipment to diagnose and treat various diseases under the guidance of medical imaging equipment, based on imaging diagnosis and clinical diagnosis, combined with the principles of clinical therapy. That is: under the guidance of medical imaging (X-ray, ultrasound, CT, MRI), special catheters or instruments are inserted into the lesion site through percutaneous puncture or through the original channels of the human body for diagnostic imaging and treatment, or tissue collection for cytological, bacteriological and biochemical examinations.

[0004] Interventional radiology provides new drug administration routes and surgical methods for modern medical diagnosis and treatment. Compared with traditional drug administration routes and surgical methods, it is more direct, effective, simpler and minimally invasive. Interventional radiology has opened up new treatment routes that are simple, safe, less invasive, less complication, and quick to take effect. It is minimally invasive, highly repeatable, accurately positioned, highly effective, and quick to take effect. The incidence of complications is low, and the combination of multiple technologies is simple and easy to apply.

[0005] Interventional radiology can be divided into interventional diagnosis and interventional therapy according to its purpose; according to its technology, it can be divided into vascular interventional radiology (drug infusion; embolization technology; formed stents; filter technology, etc.) and non-vascular interventional radiology (puncture biopsy; drainage technology; foreign body removal; cavity stents, etc.); according to its clinical application scope, it can be divided into tumor interventional radiology, non-tumor interventional radiology, neuro-interventional radiology, etc.

[0006] Interventional instruments are devices used to implement interventional diagnosis and treatment, such as vascular stent kits, percutaneous biopsy kits, radiofrequency ablation kits, tumor embolization kits, etc. Interventional instruments generally include but are not limited to any of the following or a combination thereof: puncture instruments, radiofrequency instruments, microwave instruments, particle instruments, implant instruments, sheath instruments, tube instruments, biopsy instruments, etc. Interventional instruments may include one or more interventional tools, which may be catheters, guidewires, puncture needles, vascular sheaths, balloons, biopsy needles, etc.

[0007] Catheter technology is widely used in interventional radiology. In the past, catheter instruments were mostly used to establish channels for interventional surgical instruments, and most of them did not have the function of bending and guiding at specific locations (Li Yanhao. Practical Clinical Interventional Diagnosis and Treatment Illustrated [M]. Beijing: Science Press, 2012.).

[0008] At present, some catheter devices used clinically in human blood vessels and organs need to be bent at a certain angle at a specific position after entering the human body, and guide interventional surgical instruments such as puncture needles and guide wires after bending. For example, the plastic catheter device and metal catheter device of the RUPS-100 puncture assembly produced by COOK in the United States have a bending guide structure at a specific position to achieve the corresponding guiding function.

[0009] During the intervention process, in order to guide the intervention, the distal end of the catheter device is sometimes required to rest against the intervention target, so that the intervention device passes through the catheter device, extends out of the distal end of the catheter device, and accurately intervenes at the intervention target.

[0010] In order to prevent the distal end of the catheter instrument from causing damage to the tissue it passes through during the process of passing through the interventional pathway to reach the interventional target, a flexible sleeve may be provided on the outside of the catheter. The flexible sleeve extends beyond the distal end of the catheter so that the distal end of the catheter is covered by the flexible sleeve to prevent it from damaging surrounding tissue.

[0011] In interventional surgery, especially interventional surgery with a long and tortuous interventional pathway, the interventional device needs to be bent at a certain angle in the blood vessel through the catheter device before performing blood vessel or tissue intervention. When the distal end of the flexible sleeve mounted outside the catheter is against the intervention target, due to the flexibility of the flexible sleeve, it cannot be kept at the intervention target during the intervention process, which often leads to errors such as needle skipping and failure to insert the needle or changes in the intervention direction during the intervention process, causing great difficulty for the operator. At present, the operator can only rely on the support of the catheter outside the body or pressing on specific parts of the human body, which greatly increases the difficulty of the operator's operation and limits the application of surgery.

[0012] For example, in transjugular intrahepatic puncture surgery, the key to successful puncture is to keep the catheter instrument at the puncture target point on the wall of the hepatic vein (Li Yanhao. Practical Clinical Interventional Diagnosis and Treatment Illustrated [M]. Beijing: Science Press, 2012.). However, the current puncture components cannot effectively solve this problem (Chu Jianguo, The current status and standardization of transjugular intrahepatic portosystemic shunt technology in my country, Chinese Journal of Interventional Radiology Electronics, 2013, 1(2)).

[0013] Therefore, there is an urgent need for a catheter device that can prevent damage to surrounding tissues and remain at the intervention target during the intervention process, so as to prevent errors such as needle skipping and failure to puncture or changes in the intervention direction during the intervention process. Summary of the invention

[0014] In view of this, an embodiment of the present invention provides an interventional catheter device to solve one or more of the problems in the above-mentioned existing interventional surgeries, such as easy damage to surrounding tissues, difficulty in staying at the interventional target point, difficulty in operation, and poor accuracy, so as to achieve easier-to-operate, more accurate and effective interventional surgeries.

[0015] According to one aspect of the present invention, the present invention provides an interventional catheter device, characterized in that it includes: a guide tube; a flexible sleeve, wherein the flexible sleeve is arranged outside the guide tube; the flexible sleeve and the guide tube can move relative to each other, so that the distal end of the flexible sleeve extends beyond the distal end of the guide tube, or the distal end of the guide tube extends beyond the distal end of the flexible sleeve.

[0016] Furthermore, a tapered portion is provided at the distal end of the flexible sleeve, the inner diameter of the tapered portion is smaller than the outer diameter of the guide tube, and the tapered portion is provided with a weakened portion that is easily damaged. When the interventional catheter instrument abuts against the interventional target, the guide tube is moved distally relative to the flexible sleeve to destroy the weakened portion, so that the guide tube extends beyond the distal end of the flexible sleeve.

[0017] Furthermore, the weakened portion extends to the distal opening of the flexible sleeve.

[0018] Further, the weakened portion extends along the longitudinal direction of the flexible sleeve in a straight line or a spiral manner to the distal end opening of the flexible sleeve.

[0019] Furthermore, the weakened portion is a discontinuous score line or indentation.

[0020] Furthermore, the weakened portion is arranged on the inner surface or the outer surface of the weakened portion.

[0021] Furthermore, the inner diameter of the necked portion is 0.05 mm to 1 mm smaller than the outer diameter of the guide tube.

[0022] Furthermore, the material of the flexible sleeve includes but is not limited to one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12, block polyether amide elastomer, and high-density polyethylene.

[0023] Furthermore, the material of the guide tube includes but is not limited to one or more of stainless steel and nickel-titanium alloy.

[0024] Furthermore, the thickness specifications of the guide tube include but are not limited to: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm to 57cm.

[0025] Furthermore, the inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.

[0026] Furthermore, the interventional catheter instrument includes a connector, through which the proximal end of the guide tube is connected to the proximal end of the flexible sleeve, and through which the guide tube and the flexible sleeve can move relative to each other.

[0027] Furthermore, the connection method of the connecting piece is a threading method, a snap-fit ​​method or a bonding method.

[0028] According to one aspect of the present invention, the present invention provides an interventional instrument, which includes the interventional catheter instrument described above.

[0029] In summary, the interventional catheter device according to the present invention can not only prevent damage to the surrounding tissues it passes through, but also maintain the catheter device at the intervention target point during the intervention process, so as to prevent the error of needle skipping and puncture failure or the error of change in intervention direction during the intervention process. It is easier to operate, more accurate and effective, thereby solving the technical problems existing in the prior art. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The features and advantages of the present invention will become more easily understood through the following detailed description provided with reference to the accompanying drawings, in which:

[0031] Figure 1 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention;

[0032] Figure 2 is a schematic diagram of a guide tube according to an embodiment of the present invention;

[0033] Figure 3 is a schematic diagram of a flexible sleeve according to an embodiment of the present invention;

[0034] Figure 4 is a schematic diagram of the assembly of the guide tube and the flexible sleeve according to an embodiment of the present invention;

[0035] Figure 5 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of passing through the interventional pathway to reach the interventional target point;

[0036] Figure 6 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when performing puncture guidance;

[0037] Figure 7 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of withdrawing through the interventional pathway after the puncture guidance is implemented;

[0038] Figure 8Schematic diagram of a flexible sleeve with distal shrinkage molding according to an embodiment of the present invention;

[0039] Fig. 9 is a schematic diagram of a necked portion of a flexible sleeve according to an embodiment of the present invention;

[0040] Fig.10 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of passing through the interventional pathway to reach the interventional target point;

[0041] Fig.11 is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when performing puncture guidance;

[0042] Fig.12 It is a schematic diagram of the state of the guide tube and the flexible sleeve of an embodiment of the present invention during the withdrawal process through the interventional pathway after the puncture guidance is implemented. DETAILED DESCRIPTION

[0043] The following is a detailed description of exemplary embodiments of the present invention with reference to the accompanying drawings. The description of the exemplary embodiments is only for illustrative purposes and is in no way intended to limit the present invention and its application or usage.

[0044] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0045] As used in the present invention, the singular forms "a", "an", and "the" include plural objects unless the context clearly indicates otherwise. As used in the present invention, the term "or" is generally used in a sense including "and / or", unless the context clearly indicates otherwise. The "distal end" and "distal side" mentioned in the present invention refer to the side away from the operator; correspondingly, the "proximal end" and "proximal side" are the side opposite to the "distal end" and "distal side".

[0046] Figure 1 FIG. 1 is a schematic diagram of the assembly of an interventional catheter device and a puncture needle according to an embodiment of the present invention. Figure 1 As shown, the catheter device 1 may include a guide tube 11 and a flexible sleeve 12 to provide guidance for the puncture needle 2. According to clinical needs, the catheter device 1 may be linear or curved, for example, the curved one may be used for transjugular intrahepatic puncture surgery.

[0047] Figure 2Schematic diagram of the guide tube of the embodiment of the present invention. In the embodiment of the present invention, the material of the guide tube 11 may include but is not limited to one or more of stainless steel, nickel-titanium alloy, etc. According to clinical needs, the thickness specifications of the guide tube 11 may include but are not limited to: 13G, 14G, 15G, 16G, etc. (G is the abbreviation of GAUGE, which is a length measurement unit for diameter originating in North America); the length specification may be 42cm to 57cm.

[0048] like Figure 2 As shown, the distal end of the guide tube 11 may be of an oblique blade type, which can be used for puncture, and can also be used to penetrate into an intervention target site and thus abut against the intervention target site.

[0049] like Figure 2 As shown, according to clinical needs, the distal side of the guide tube 11 can form one or more bends. In one embodiment of the present invention, the distal end of the guide tube 11 is a curved bevel blade type, and can be bent 10° to 80°, for example 60°, at 0.5 cm to 12 cm from the bevel blade tip.

[0050] Figure 3 is a schematic diagram of a flexible sleeve of an embodiment of the present invention. In the embodiment of the present invention, the material of the flexible sleeve 12 may include but is not limited to one or more of polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), thermoplastic polyurethane elastomer (TPU), nylon 12 (PA12), segmented polyetheramide elastomer (Pebax), high-density polyethylene (HDPE), etc.

[0051] Figure 4 Schematic diagram of the assembly of the guide tube and the flexible sleeve of the embodiment of the present invention. Figure 4 As shown, the flexible sleeve 12 can be sleeved outside the guide tube 11, and its inner diameter can be 0.1mm to 2mm larger than the outer diameter of the guide tube 11. The guide tube 11 and the flexible sleeve 12 can move relative to each other, so that the distal end of the guide tube 11 can extend beyond the distal end of the flexible sleeve 12, or the distal end of the flexible sleeve 12 can extend beyond the distal end of the guide tube 11 (such as Figure 4 shown).

[0052] In the embodiment of the present invention, the proximal end of the flexible sleeve 12 can be connected to the proximal end of the guide tube 11 by means of threads, buckles or bonding via the connector 13, and the flexible sleeve 12 and the guide tube 11 can be moved relative to each other via the connector 13. Figure 1 or Figure 4 It is shown that the flexible sheath 12 and the proximal end of the guide tube 11 are connected in a threaded manner via a connector 13 .

[0053] In the puncture surgery of the embodiment of the present invention, the catheter device 1 including the guide tube 11 and the flexible sleeve 12 first enters the body through an interventional route such as percutaneous or organ cavity to reach the puncture target point. Figure 5FIG. 1 is a schematic diagram of the state of the guide tube and the flexible sleeve of an embodiment of the present invention in the process of reaching the intervention target through the intervention pathway. Figure 5 As shown, during this process, the flexible sleeve 12 is sleeved outside the guide tube 11, and the distal end of the flexible sleeve 12 extends beyond the distal bevel of the guide tube 11 by 2 to 3 mm to prevent the distal bevel from damaging the tissues it passes through.

[0054] In the puncture surgery of the embodiment of the present invention, when the distal end of the catheter device 1 reaches the puncture target, the guide tube 11 and the flexible sleeve 12 can be moved relative to each other, so that the distal end of the guide tube 11 extends beyond the distal end of the flexible sleeve 12, so that the distal end of the guide tube 11 can be against the puncture target and remain motionless to implement puncture guidance. Figure 6 It is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when implementing puncture guidance.

[0055] In the puncture surgery of the embodiment of the present invention, when the catheter instrument 1 is to be withdrawn through the interventional pathway after implementing the puncture guidance, the guide tube 11 and the flexible sleeve 12 can be moved relative to each other so that the distal end of the flexible sleeve 12 extends beyond the distal bevel blade of the guide tube 11 to prevent the distal bevel blade from damaging the tissue passed through. Figure 7 It is a schematic diagram of the state of the guide tube and the flexible sleeve of an embodiment of the present invention during the withdrawal process through the interventional pathway after the puncture guidance is implemented.

[0056] In interventional diagnosis and treatment, the distal end of the catheter instrument will be subject to resistance from the tissues and organs it passes through as it passes through the interventional pathway to reach the interventional target, especially in interventional surgeries with long and tortuous pathways. Due to the flexibility of the flexible sheath, the flexible sheath often moves proximally relative to the guide tube, causing the distal end of the guide tube to extend beyond the distal end of the flexible sheath, thereby damaging the surrounding tissues it passes through.

[0057] To solve this technical problem, further, in an embodiment of the present invention, the distal end of the flexible sleeve 12 can be subjected to a shrinkage molding process to form a shrinkage portion 121. The shrinkage portion 121 can be conical. After molding, the inner diameter of the shrinkage portion can be 0.05mm to 1mm smaller than the outer diameter of the guide tube 11. Figure 8 Schematic diagram of a flexible sleeve with distal shrinkage molding according to an embodiment of the present invention.

[0058] Since the inner diameter of the distal end of the constricted portion of the flexible sleeve 12 is smaller than the outer diameter of the distal end of the guide tube 11, during the process of the catheter device 1 passing through the interventional pathway to reach the interventional target, the flexible sleeve 12 will not move proximally relative to the guide tube 11 even if it is affected by the resistance of the tissues and organs it passes through, so that the guide tube 11 will not extend from the distal end of the flexible sleeve 12, thereby damaging the tissues it passes through.

[0059] further, Fig. 9Schematic diagram of the necking portion of the flexible sleeve of the embodiment of the present invention. In the embodiment of the present invention, the necking portion 121 of the flexible sleeve 12 may be provided with a weakened portion 1211 that is easily damaged, such as Fig. 9 As shown. The weakened portion 1211 may extend to the distal opening of the flexible sleeve 12. The weakened portion 1211 may be a discontinuous score line or indentation, and may extend in a straight line or spirally along the longitudinal direction of the flexible sleeve 12 to the distal opening thereof. The weakened portion 1211 may be disposed on the inner surface or the outer surface of the necked portion 121. When the weakened portion 1211 is disposed on the outer surface of the necked portion 121, a depression may be formed on the outer surface, which may stimulate the blood vessel wall and affect the blood flow, thereby increasing the possibility of thrombus formation. Therefore, preferably, the weakened portion 1211 is disposed on the inner surface of the necked portion 121.

[0060] The weakened portion 1211 allows the guide tube 11 to break the weakened portion 121 and extend out of the distal opening of the flexible sleeve 12 when a force greater than the above resistance is applied to push the guide tube 11 distally relative to the flexible sleeve 12 when the catheter device 1 abuts against the intervention target. In one embodiment of the present invention, the weakened portion 121 is a longitudinal indentation with a width of 1 mm.

[0061] Therefore, in the puncture surgery of the embodiment of the present invention, the guide tube 11 and the flexible sleeve 12 first enter the body through an interventional route such as percutaneous or organ cavity to reach the puncture target point. Fig.10 Schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention in the process of reaching the intervention target through the intervention pathway; Fig.10 As shown, during this process, the flexible sleeve 12 is sleeved outside the guide tube 11, and the constricted portion of the flexible sleeve 12 extends beyond the distal bevel of the guide tube 11 by 2 to 3 mm to prevent the distal bevel from damaging the tissue it passes through.

[0062] In the puncture surgery of the embodiment of the present invention, when the distal end of the catheter device 1 reaches the puncture target point, a force greater than the above resistance can be applied to push the guide tube 11 distally relative to the flexible sleeve 12, so that the guide tube 11 destroys the weakened portion 121 and extends 2 to 3 mm from the distal opening of the flexible sleeve 12. In this way, the distal oblique blade of the guide tube 11 can penetrate the puncture target point, so that it can always remain at the puncture target point during the puncture process to provide a puncture guide for the puncture needle 2. Then the puncture needle 2 can be passed through the catheter device 1 to puncture the puncture target point. Fig.11 It is a schematic diagram of the state of the guide tube and the flexible sleeve of the embodiment of the present invention when implementing puncture guidance.

[0063] In the embodiment of the present invention, after the puncture of the puncture needle 2 is completed, the guide tube 11 can be pulled back proximally relative to the flexible sleeve 12, so that the distal beveled blade of the guide tube 11 is retracted into the distal opening of the flexible sleeve 12 by 3 to 5 mm. Afterwards, the guide tube 11 and the flexible sleeve 12 are taken out along the original interventional pathway. Since the distal beveled blade of the guide tube 11 has been retracted into the distal opening of the flexible sleeve 12, it will not cause damage to the tissues it passes through. In addition, during the withdrawal of the catheter device 1, the direction of the resistance applied to the flexible sleeve 12 is in the distal direction, which will not cause the flexible sleeve 12 to move proximally relative to the guide tube 11, and will not cause the distal end of the guide tube 11 to extend beyond the distal end of the flexible sleeve 12 and cause damage to the tissues it passes through. Fig.12 It is a schematic diagram of the state of the guide tube and the flexible sleeve of an embodiment of the present invention during the withdrawal process through the interventional pathway after the puncture guidance is implemented.

[0064] Interventional instruments are devices used to implement interventional diagnosis and treatment, such as vascular stent kits, percutaneous biopsy kits, radiofrequency ablation kits, tumor embolization kits, etc. Interventional instruments generally include but are not limited to any of the following or a combination thereof: puncture instruments, radiofrequency instruments, microwave instruments, particle instruments, implant instruments, sheath instruments, tube instruments, biopsy instruments, etc. Interventional instruments may include one or more interventional tools, which may be catheters, guidewires, puncture needles, vascular sheaths, balloons, biopsy needles, etc.

[0065] In an embodiment of the present invention, an interventional instrument may be provided, and the interventional instrument may include the interventional catheter instrument described above.

[0066] The interventional catheter device of the embodiment of the present invention can not only prevent damage to the surrounding tissues it passes through, but also maintain the intervention target point in the blood vessel or tissue during the intervention process, and provide the operator with a stable and reliable guide structure to guide puncture or insertion of interventional devices. The structure and process of the interventional catheter device are simple, low cost, good operability, high efficiency and safety, and can meet the operator's requirements for precise guidance during curved puncture.

[0067] In summary, the above embodiments describe the interventional catheter device in detail. Of course, the present invention includes but is not limited to the above embodiments. Any changes based on the above embodiments fall within the scope of protection of the present invention. Those skilled in the art can draw inferences based on the above embodiments.

[0068] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the scope of protection of the claims.

[0069] Although the present invention has been described with reference to exemplary embodiments, it should be understood that the present invention is not limited to the specific embodiments described and illustrated in detail herein, and that those skilled in the art may make various changes to the exemplary embodiments without departing from the scope defined by the claims, and all such changes shall fall within the scope of protection of the present invention.

[0070] Although the preferred embodiments of the present invention have been described, those skilled in the art may make other changes and modifications to these embodiments once they have learned the basic creative concept. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the present invention.

[0071] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. An interventional catheter device, characterized in that: include: A guide tube, the distal end of which is an oblique blade type, for piercing and penetrating the intervention target so as to abut against the intervention target; A flexible sleeve, the flexible sleeve being arranged outside the guide tube; The flexible sleeve and the guide tube are relatively movable, so that the distal end of the flexible sleeve extends beyond the distal end of the guide tube, or the distal end of the guide tube extends beyond the distal end of the flexible sleeve; The distal end of the flexible sleeve is provided with a constricted portion, the inner diameter of the constricted portion is smaller than the outer diameter of the guide tube, and the constricted portion is provided with a weakened portion that is easily damaged. When the interventional catheter device abuts against the interventional target, the guide tube is moved distally relative to the flexible sleeve to damage the weakened portion, so that the guide tube extends beyond the distal end of the flexible sleeve; The weakened portion is a discontinuous score line or indentation extending to the distal opening of the flexible sleeve, and the weakened portion is arranged on the inner surface of the necked portion; During the puncture operation, when the distal end of the interventional catheter device reaches the puncture target point, the guide tube and the flexible sleeve move relative to each other, so that the distal end of the guide tube extends beyond the distal end of the flexible sleeve, and the distal end of the guide tube rests against the puncture target point without moving to implement puncture guidance; when the interventional catheter device is to be withdrawn through the interventional pathway after implementing puncture guidance, the guide tube and the flexible sleeve move relative to each other, so that the distal end of the flexible sleeve extends beyond the distal bevel blade of the guide tube, so as to prevent the distal bevel blade of the guide tube from damaging the tissue passed through.

2. The interventional catheter device according to claim 1, characterized in that: The weakened portion extends along the longitudinal direction of the flexible sleeve in a straight line or a spiral manner to the distal end opening of the flexible sleeve.

3. The interventional catheter device according to claim 1, characterized in that: The inner diameter of the necked portion is 0.05 mm to 1 mm smaller than the outer diameter of the guide tube.

4. The interventional catheter device according to claim 1, characterized in that: The material of the flexible sleeve includes one or more of polytetrafluoroethylene, fluorinated ethylene propylene copolymer, thermoplastic polyurethane elastomer, nylon 12, block polyether amide elastomer, and high-density polyethylene.

5. The interventional catheter device according to claim 1, characterized in that: The material of the guide tube includes one or more of stainless steel and nickel-titanium alloy.

6. The interventional catheter device according to claim 1, characterized in that: The thickness specifications of the guide tube include: 13G, 14G, 15G, 16G, and the length of the guide tube is 42cm to 57cm.

7. The interventional catheter device according to claim 1, characterized in that: The inner diameter of the flexible sleeve is 0.1 mm to 2 mm larger than the outer diameter of the guide tube.

8. The interventional catheter device according to claim 1, characterized in that: The interventional catheter instrument comprises a connecting piece, through which the proximal end of the guide tube is connected to the proximal end of the flexible sleeve, and through which the guide tube and the flexible sleeve can be relatively moved.

9. The interventional catheter device according to claim 8, characterized in that: The connection method of the connecting piece is threading, snap-fitting or bonding.

10. An interventional device, characterized in that: The interventional device comprises an interventional catheter device according to any one of claims 1-9.

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