Vascular intervention catheter assembly and vascular intervention device

Abstract

The utility model discloses a vascular intervention catheter assembly and a vascular intervention device.The vascular intervention catheter assembly comprises a main catheter and a supporting catheter, and the main catheter comprises a first catheter cavity; the supporting catheter comprises a second catheter cavity; the vascular intervention catheter assembly at least comprises a first operation state and a second operation state, and in the second operation state, the main catheter penetrates to the target blood vessel position, and the supporting catheter penetrates into the first catheter cavity and reaches the target blood vessel position. The problems that in the prior art, when catheter supporting force is insufficient, interventional operation difficulty is increased, operation is more complex, and efficiency is low are solved. According to the vascular intervention catheter assembly and the vascular intervention device, when the supporting force of the main catheter is insufficient to complete the interventional operation, the supporting catheter is arranged in the first catheter cavity of the main catheter in the penetrating mode, so that the main catheter and the supporting catheter achieve dual supporting on the target vascular position, the supporting force on the target vascular position is improved, and the interventional operation is more accurate. Compared with the prior art, the sheath tube and the catheter do not need to be pulled out again for replacement, the operation difficulty is reduced, the operation operation is simplified, and the interventional treatment efficiency is improved.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and particularly relates to a vascular interventional catheter assembly and a vascular interventional device. Background Art

[0002] Vascular interventional devices are medical devices used in vascular interventional surgeries. They perform diagnoses, treatments, or lesion repairs on the cardiovascular system in the body through catheter intervention. During a vascular interventional surgery, a doctor selects a suitable puncture site on the patient's artery or vein, such as the femoral artery, radial artery, etc., and performs disinfection and anesthesia. Then, a special puncture needle is used to introduce a guide wire sheath into the blood vessel. Through the guide wire sheath, a doctor introduces a slender guide wire into the blood vessel and sends other interventional instruments, such as catheters, balloons, stents, etc., to the lesion site along the guide wire. After the guide wire and the interventional instrument reach the lesion site, the doctor uses a contrast agent for angiography to more accurately understand the lesion condition. According to the results of the angiography examination, the doctor uses the interventional instrument for corresponding treatment. For example, for vascular stenosis or occlusion, a balloon dilator or stent can be used for vascular dilation or support; for tumors or hemangiomas, an embolizing agent can be used for embolization treatment, etc.

[0003] However, in some special interventional surgeries, due to the patient's own vascular conditions, the supporting force of the catheter is insufficient, and it is impossible to smoothly perform the interventional treatment. The doctor needs to withdraw the sheath outside the catheter from the patient's blood vessel and replace it with a sheath with greater or longer supporting force, and then reinsert the catheter into the blood vessel. This increases the difficulty of the interventional surgery, makes the operation more complex, and has low efficiency. Summary of the Invention

[0004] The embodiments of this application provide a vascular interventional catheter assembly and a vascular interventional device, which can reduce the difficulty of interventional surgery, make the operation simpler, and improve the operation efficiency.

[0005] On the one hand, the embodiments of this application provide a vascular interventional catheter assembly, including:

[0006] A main catheter, the main catheter includes a first catheter lumen;

[0007] A support catheter, the support catheter includes a second catheter lumen;

[0008] The vascular interventional catheter assembly has at least a first working state and a second working state. In the first working state, the main catheter is inserted to the target blood vessel position, and the first catheter lumen can pass a guide wire through;

[0009] In the second working state, the main catheter is inserted to the target blood vessel position, the support catheter is inserted into the first catheter lumen and reaches the target blood vessel position, and the second catheter lumen can pass the guide wire through.

[0010] According to the vascular intervention catheter assembly provided by the present application, the support catheter includes a spring wire winding structure distributed along its own length direction.

[0011] According to the vascular intervention catheter assembly provided by the present application, the support catheter includes a support section and a functional section distributed along its own length direction, and at least the support section includes the spring wire winding structure.

[0012] According to the vascular intervention catheter assembly provided by the present application, both the support section and the functional section include the spring wire winding structure, and the spring wire winding pitch of the support section is smaller than that of the functional section.

[0013] According to the vascular intervention catheter assembly provided by the present application, the support section and the functional section are continuous spring wire winding structures, and in the direction from the support section to the functional section, the spring wire winding pitch of the support catheter shows a gradually increasing trend.

[0014] According to the vascular intervention catheter assembly provided by the present application, it includes a distal end and a proximal end that are opposite to each other along its own length direction. The vascular intervention catheter assembly intervenes in human tissues through the distal end. It is characterized in that the support section is close to the distal end, the functional section is close to the proximal end, and in the direction from the support section to the functional section, the inner diameter of the support catheter shows a gradually increasing trend.

[0015] According to the vascular intervention catheter assembly provided by the present application, the main catheter includes a reinforcing section, and the reinforcing section includes a spring wire winding structure;

[0016] In the second operating state, both the reinforcing section and the support section are placed at the target blood vessel position.

[0017] According to the vascular intervention catheter assembly provided by the present application, the working length of the support catheter is less than the working length of the main catheter.

[0018] According to the vascular intervention catheter assembly provided by the present application, a first imaging ring is provided at the inlet end of the main catheter, and a second imaging ring is provided at the inlet end of the support catheter.

[0019] On the other hand, an embodiment of the present application further provides a vascular intervention device, including a guide wire and the above-mentioned vascular intervention catheter assembly. In the second operating state, the guide wire is movably inserted into the second catheter lumen.

[0020] The vascular interventional catheter assembly and vascular interventional device according to the embodiments of the present application include a main catheter and a support catheter. In the first working state, the main catheter enters the blood vessel. When the supporting force of the main catheter is sufficient to complete the interventional operation, the support catheter is in a non-working state; after the first working state is completed, the supporting force of the main catheter is insufficient to complete the interventional operation. At this time, the vascular interventional catheter assembly enters the second working state, and the support catheter is inserted into the first catheter lumen of the main catheter, so that the main catheter and the support catheter provide double support for the target blood vessel position, improving the supporting force for the target blood vessel position. Compared with the prior art, the present application does not require re-withdrawing the sheath and catheter for replacement, reducing the surgical difficulty, simplifying the surgical operation, and improving the efficiency of interventional treatment. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings required to be used in the embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0022] Figure 1 FIG. shows the structural schematic diagram of the vascular interventional catheter assembly provided by some embodiments of the present application in the first working state;

[0023] Figure 2 FIG. shows the structural schematic diagram of the vascular interventional catheter assembly in the second working state;

[0024] Figure 3 FIG. shows the cross-sectional view of the spring wire winding structure of the support section of the support catheter provided by some embodiments of the present application;

[0025] Figure 4 FIG. shows the cross-sectional view of the spring wire winding structure of the functional section of the support catheter provided by some embodiments of the present application.

[0026] Reference numerals: 100: main catheter; 101: reinforcement section; 102: second sheath opening; 103: second imaging ring; 200: support catheter; 201: support section; 202: functional section; 203: first sheath opening; 204: first imaging ring; distal end: 300; proximal end: 400. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0027] The features and exemplary embodiments of various aspects of the present application will be described in detail below. To make the objectives, technical solutions, and advantages of the present application clearer and more understandable, the present application will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only intended to explain the present application and not to limit the present application. For those skilled in the art, the present application can be implemented without some of these specific details. The following description of the embodiments is only to provide a better understanding of the present application by showing examples of the present application.

[0028] It should be noted that, in this document, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "comprising..." does not exclude the existence of additional identical elements in the process, method, article or device comprising the said element.

[0029] During a vascular interventional procedure, a sheath needs to be inserted at the puncture site, and then a guide wire is used in conjunction with a catheter to reach the site that requires surgical intervention. For example, for a patient with a tortuous iliac artery, due to the excessive bending angle of the blood vessel, it may occur that after the guide wire and catheter reach the lesion site, the tortuous iliac artery causes insufficient catheter support force, resulting in inability to rotate, making it difficult to perform super-selective catheterization of the blood vessel and pass through the stenotic segment. In such a case, the prior art usually requires replacing the sheath with a longer one to support the iliac artery and reduce the tortuous angle, thereby increasing the mobility of the catheter.

[0030] In some lesion surgeries, such as when a patient has renal artery stenosis and the iliac artery is in a tortuous state, it is necessary to replace the sheath with a long one. At the same time, the diameter of the long sheath is relatively large, which poses challenges to the compression and suture of the puncture site after the operation. In addition, the cost of the large sheath is often relatively high. At the same time, it is found that the catheter is difficult to rotate after the guide wire and catheter are in place, and the entire operation of replacing the sheath is time-consuming and laborious, and there is a possibility of losing the corresponding blood vessel access.

[0031] In the state where the support force of the catheter is insufficient, without replacing the sheath and the catheter, the present application inserts the support catheter 200 into the main catheter 100 that has entered the blood vessel to improve the support force of the main catheter, thereby reducing the operation difficulty and improving the operation efficiency.

[0032] To solve the problems of the prior art, the embodiments of the present application provide a vascular intervention catheter assembly and a vascular intervention device. First, the vascular intervention catheter assembly provided by the embodiments of the present application will be introduced below.

[0033] Figure 1 The schematic structural diagram of the vascular intervention catheter assembly provided by some embodiments of the present application in the first working state is shown. Figure 2 The schematic structural diagram of the vascular intervention catheter assembly in the second working state is shown.

[0034] As Figure 1 and Figure 2 shown, the present application provides a vascular intervention catheter assembly, including: a main catheter 100 and a support catheter 200. The main catheter 100 includes a first catheter lumen; the support catheter 200 includes a second catheter lumen; the vascular intervention catheter assembly includes at least a first operation state and a second operation state. In the first operation state, the main catheter 100 is inserted into the target blood vessel position, and the first catheter lumen can pass a guide wire; in the second operation state, the main catheter 100 is inserted into the target blood vessel position, the support catheter 200 is inserted into the first catheter lumen of the main catheter 100 and reaches the target blood vessel position, and the second catheter lumen can pass a guide wire.

[0035] In a vascular intervention operation, a puncture site is formed on the skin tissue through a puncture needle, a sheath tube is inserted into the puncture site, and then, a guide wire is inserted into the sheath tube and reaches the lesion position along the blood vessel. In the first working state of the vascular intervention catheter assembly, the main catheter 100 is sleeved outside the guide wire, that is, the guide wire is inserted into the first catheter lumen, and is inserted along the guide wire to the target blood vessel position to provide a supporting force for the movement of the guide wire, so as to make the intervention operation proceed smoothly.

[0036] However, in some special patients, the blood vessels in special positions have a certain degree of distortion, resulting in the main catheter 100 being unable to provide sufficient supporting force, and the distortion angle of the blood vessel is still very large, restricting the activities of the main catheter 100 and the guide wire. For example, when the iliac artery has severe distortion. The vascular intervention catheter assembly enters the second working state. At this time, on the basis of the first working state, the support catheter 200 is inserted into the first catheter lumen of the main catheter 100, and the second catheter lumen of the support catheter 200 is sleeved outside the guide wire. That is to say, the support catheter 200 is placed between the main catheter 100 and the guide wire; until the support catheter 200 reaches the target blood vessel position. Both the support catheter 200 and the main catheter 100 provide supporting force for the target blood vessel position, for example, providing supporting force for the distorted position of the iliac artery, so as to improve the supporting effect, increase the mobility of the main catheter 100 and the guide wire, and make the intervention operation proceed smoothly.

[0037] Without the need to replace the sheath and the main catheter 100, the present application improves the supporting force for blood vessels, reduces the operation difficulty and complexity of interventional surgery, and improves the efficiency of interventional treatment. Compared with the existing solution of replacing a sheath with a larger diameter and longer length, the present application has lower costs and avoids further puncture injuries to patients caused by large-diameter sheaths. It can reduce the accidental risks of blood vessels caused by re-replacing the catheter, avoid further radiation injuries to doctors and patients caused by secondary operations, avoid re-angiography, and reduce the radiation dose.

[0038] In order to improve the supporting force of the supporting catheter 200, in an embodiment of the present application, the supporting catheter 200 includes a spring winding structure distributed along its own length direction.

[0039] Among them, the cross-section of the spring winding structure can be circular or rectangular. For example, the spring winding structure adopted in the supporting catheter 200 in this embodiment is rectangular and is wound by a spring winding with a rectangular cross-section, so that the supporting catheter 200 is a rectangular spring structure. Compared with the existing supporting catheter 200 wound by a wire with a circular cross-section, the supporting catheter 200 wound by a spring winding with a rectangular cross-section has a higher supporting force. For example, the spring winding of the supporting catheter 200 of the present application is wound along the long axis, with more uniform force and longer service life.

[0040] In addition, the supporting catheter 200 further includes an inner layer and an outer layer, and the inner layer and the outer layer cover the spring winding structure therein. The inner layer and the outer layer can be polytetrafluoroethylene, which has the characteristics of high temperature resistance and smooth surface, and the edge supports the movement of the supporting catheter 200 in the first catheter cavity of the main catheter 100.

[0041] Regarding the distribution of the spring winding structure of the supporting catheter 200, in a specific embodiment of the present application, with continued reference to Figure 1 , the supporting catheter 200 includes a supporting section 201 and a functional section 202 distributed along its own length direction, and at least the supporting section 201 includes a spring winding structure.

[0042] That is to say, a part of the area of the supporting catheter 200 adopts a spring winding structure to improve the local supporting strength of the supporting catheter 200. Among them, the functional section 202 can be made of polymer material. The supporting section 201 can have multiple segments and can be distributed at different positions in the length direction of the supporting catheter 200. For example, the lengths of the multiple supporting sections 201 on the supporting catheter 200 are equal, the lengths of the multiple functional sections 202 are equal, and the supporting sections 201 and the functional sections 202 are arranged alternately, thereby reducing the weight of the supporting catheter 200.

[0043] Figure 3 Shows a cross-sectional view of the spring winding structure of the supporting section 201 of the supporting catheter 200 provided in some embodiments of the present application. Figure 4Shows a cross-sectional view of the spring-wound wire structure of the functional section 202 of the support catheter 200 provided by some embodiments of the present application.

[0044] As Figure 3 and Figure 4 shown, in another embodiment of the present application, both the support section 201 and the functional section 202 of the support catheter 200 include a spring-wound wire structure, and the pitch of the spring-wound wire of the support section 201 is smaller than the pitch of the spring-wound wire of the functional section 202.

[0045] Specifically, the whole of the support catheter 200 is a spring-wound wire structure, and the pitches of the spring-wound wires of the support section 201 and the functional section 202 are different. The pitch of the spring-wound wire of the support section 201 is smaller than the pitch of the spring-wound wire of the functional section 202, so that the supporting force of the support section 201 is greater than that of the functional section 202. And the whole of the support catheter 200 is a spring-wound wire structure, which is more convenient to process. By changing the pitch of the spring-wound wire, the adjustment of the supporting force is realized. The smaller the pitch of the spring-wound wire, the stronger the supporting force, and the larger the pitch of the spring-wound wire, the better the flexibility. For example, the pitch of the spring-wound wire of the support section 201 is zero, and they are closely arranged to provide better passability and supporting force.

[0046] In some embodiments of the present application, the support section 201 and the functional section 202 of the support catheter 200 are a continuous spring-wound wire structure. From the direction of the support section 201 to the functional section 202, the pitch of the spring-wound wire of the support catheter 200 shows a gradually increasing trend.

[0047] For example, the support catheter 200 includes a section of the support section 201 and a section of the functional section 202. Both the support section 201 and the functional section 202 are wound with spring-wound wires, and the pitch of the spring-wound wires has a continuous change trend. From the support section 201 to the functional section 202, the spring pitch has an increasing trend. In some embodiments, the support section 201 is arranged at the distal end 300 of the support catheter 200. From the distal end 300 to the proximal end 400 of the spring-wound wire structure of the support catheter 200, the pitch has a gradually increasing trend, so that the supporting force of the support catheter 200 gradually decreases and the flexibility gradually increases.

[0048] Another example is that the support catheter 200 includes a section of the support section 201 and two sections of the functional section 202. The support section 201 is placed between the two sections of the functional section 202. The pitch of the spring-wound wire structure in the support section 201 can be the same. From the direction of the support section 201 to the functional section 202, the pitch of the spring-wound wire structure of the functional section 202 shows a gradually increasing trend. Or, from the middle of the support section 201 to the ends of the two functional sections 202 on both sides, the pitch of the spring-wound wire structure shows a gradually increasing trend.

[0049] In addition, in other embodiments of the present application, the vascular intervention catheter assembly includes a distal end 300 and a proximal end 400 that are opposite to each other along its length direction, and the vascular intervention catheter assembly intervenes in human tissue through the distal end 300. The support segment 201 is close to the distal end 300, and the functional segment 202 is close to the proximal end 400. From the support segment 201 to the functional segment 202, the inner diameter of the support catheter 200 gradually increases.

[0050] For example, the pitch of the spring wire structure supporting the catheter 200 tends to increase gradually from the distal end 300 to the proximal end 400, and the inner diameter of the supporting catheter 200 tends to increase gradually. The larger the pitch of the spring wire, the better the flexibility, but the supporting force is weakened. The supporting strength can be improved to a certain extent by increasing the diameter.

[0051] Continue to refer Figure 1 and Figure 2 In order to further improve the supporting force of the main catheter 100, in an optional embodiment of the present application, the main catheter 100 includes a reinforcement section 101, and the reinforcement section 101 includes a spring wire winding structure; in the second operating state, the reinforcement section 101 and the support section 201 are both placed at the target blood vessel position.

[0052] The reinforcing section 101 is placed inside the main conduit 100, and the outside of the main conduit 100 includes a smooth surface made of polytetrafluoroethylene. In the embodiment of the present application, the cross-section of the spring wire structure of the reinforcing section 101 can be rectangular, and the spring wire is rolled along the minor axis to provide greater rigidity, so that the main conduit 100 has a stronger ability to withstand impact and vibration.

[0053] For example, the reinforcement section 101 of the main catheter 100 extends into the blood vessel and reaches the twisted iliac artery to support the twisted iliac artery. When the support force is insufficient, the guide wire cannot enter the lesion position; at this time, the support catheter 200 is inserted into the first catheter lumen of the main catheter 100, so that the support section 201 of the support catheter 200 reaches the twisted iliac artery and supports the iliac artery together with the reinforcement section 101, providing sufficient support force for the entry of the guide wire. The twisted iliac artery is the target blood vessel position of the present application.

[0054] Specifically, in order to facilitate observation of the positions of the main catheter 100 and the supporting catheter 200 in the blood vessel, in other optional embodiments of the present application, a first developing ring 204 is provided at the entry end of the main catheter 100, and a second developing ring 103 is provided at the entry end of the supporting catheter 200.

[0055] Among them, the entry ends of the main catheter 100 and the support catheter 200 in this application are both the distal end 300 of the vascular intervention catheter assembly. The first imaging ring 204 and the second imaging ring 103 can be imaging rings for X-ray imaging markers, which can provide high-resolution images to facilitate doctors to clearly observe the specified part.

[0056] In the embodiment of this application, the main catheter 100 includes a first sheath opening 203 to facilitate the entry of the guide wire and the support catheter 200, and the support catheter 200 includes a second sheath opening 102 to facilitate the entry of the guide wire.

[0057] In addition, in the specific embodiment of this application, the working length of the support catheter 200 is less than that of the main catheter 100. The support catheter 200 only needs to support the blood vessel in a special state to ensure the smooth operation of the main catheter 100 and the guide wire.

[0058] For example, the length range of the main catheter 100 is from 100 cm to 125 cm, and the main catheter 100 is 6F, that is, the outer diameter is 2 mm. When the support catheter 200 has a variable diameter structure with the inner diameter of the distal end 300 smaller than that of the proximal end 400, the inner diameter of the distal end 300 of the support catheter 200 can be 0.97 mm, which can accommodate a guide wire with a diameter of 0.0035 inches to pass through. The outer diameter of the proximal end 400 of the support catheter 200 is less than or equal to 2 mm, and the length range of the support catheter 200 is from 20 cm to 50 cm. This length can enable the support catheter 200 to be inserted from the femoral artery puncture point to the iliac artery bifurcation to support the twisted iliac artery, improving the mobility of the main catheter 100 and the guide wire in the body and the flexibility during super-selective blood vessel access.

[0059] This application also provides a vascular intervention device, including a guide wire and the vascular intervention catheter assembly of the above embodiment. When the vascular intervention catheter assembly is in the second working state, the guide wire can be movably inserted into the second catheter lumen.

[0060] The above is only the specific implementation manner of this application. Those skilled in the art can clearly understand that for the convenience and brevity of description, the specific working processes of the above-described systems, modules, and units can refer to the corresponding processes in the foregoing method embodiments, which will not be repeated here. It should be understood that the protection scope of this application is not limited thereto. Any person skilled in the art within the technical scope disclosed in this application can easily think of various equivalent modifications or substitutions, and these modifications or substitutions should all be covered within the protection scope of this application.

Claims

1. A vascular intervention catheter assembly, characterized in that: include: a main catheter, the main catheter comprising a first catheter lumen; a support catheter, the support catheter comprising a second catheter lumen; The vascular intervention catheter assembly includes at least a first operating state and a second operating state. In the first operating state, the main catheter is inserted into the target blood vessel position, and the first catheter cavity can be inserted with a guide wire. In the second operating state, the main catheter is inserted into the target blood vessel, the supporting catheter is inserted into the first catheter cavity and reaches the target blood vessel, and the second catheter cavity can be inserted with the guide wire.

2. The vascular intervention catheter assembly according to claim 1, characterized in that: The supporting conduit comprises a spring wire winding structure distributed along the length direction of the supporting conduit.

3. The vascular intervention catheter assembly according to claim 2, characterized in that: The supporting conduit comprises a supporting section and a functional section distributed along its length direction, and at least the supporting section comprises the spring wire winding structure.

4. The vascular intervention catheter assembly according to claim 3, characterized in that: The support section and the functional section both include the spring wire winding structure, and the spring wire winding pitch of the support section is smaller than the spring wire winding pitch of the functional section.

5. The vascular intervention catheter assembly according to claim 3, characterized in that: The support section and the functional section are continuous spring wire winding structures, and the spring wire winding pitch of the support conduit gradually increases from the support section to the functional section.

6. The vascular intervention catheter assembly according to any one of claims 3 to 5, comprising a distal end and a proximal end opposite to each other along its length direction, wherein the vascular intervention catheter assembly intervenes in human tissue via the distal end, characterized in that: The support section is close to the distal end, the functional section is close to the proximal end, and the inner diameter of the support conduit increases gradually from the support section to the functional section.

7. The vascular intervention catheter assembly according to any one of claims 3 to 5, characterized in that: The main conduit comprises a reinforcement section, and the reinforcement section comprises a spring wire winding structure; In the second operating state, the reinforcement segment and the support segment are both placed at the target blood vessel position.

8. The vascular intervention catheter assembly according to any one of claims 1 to 5, characterized in that: The working length of the support conduit is shorter than the working length of the main conduit.

9. The vascular intervention catheter assembly according to claim 1, characterized in that: The entrance end of the main conduit is provided with a first developing ring, and the entrance end of the supporting conduit is provided with a second developing ring.

10. A vascular intervention device, characterized in that: The invention comprises a guide wire and the vascular intervention catheter assembly according to any one of claims 1 to 9, wherein in the second operating state, the guide wire is movably arranged in the second catheter cavity.

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