A lower limb artery thrombolysis catheter integrated device with a distal protection umbrella

Abstract

The present application relates to the technical field of medical devices, in particular to a lower limb artery thrombolysis catheter integrated device with a distal protection umbrella, comprising an outer catheter and a closed guide wire, and a blocking component is detachably connected to the distal end of the closed guide wire for capturing the debris generated by thrombus dissolution during lower limb artery thrombolysis. The present application integrates the thrombolytic drug delivery structure and the distal debris blocking protection umbrella, which is easy to operate during operation, reduces the distal tip embolism complications, synchronously completes thrombolysis and debris cleaning, improves the safety and treatment effect of lower limb artery interventional thrombolysis surgery, and reduces the probability of secondary interventional remedial operation.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an integrated device for lower limb arterial thrombolysis catheters with a distal protective umbrella. Background Technology

[0002] Currently, most lower extremity arterial thrombolysis catheters used in clinical practice are multi-side-hole perfusion thrombolysis catheters. Their working principle is as follows: the thrombolysis catheter is precisely placed into the thrombus-occluded segment of the lower extremity artery through interventional puncture. The end hole at the tip of the catheter is sealed with a guidewire, forcing the thrombolytic drug to diffuse out only through the dense side holes on the side wall of the catheter, so that a high drug concentration is formed in the local thrombus. Thrombolytic drugs such as urokinase and recombinant tissue plasminogen activator are continuously perfused through a micro-infusion pump to activate plasminogen inside the thrombus, break down the fibrin network structure of the thrombus, gradually dissolve the occluded thrombus, open the arterial blood vessel, and restore blood flow perfusion to the lower extremity.

[0003] However, thrombolytic drugs dissolve thrombi through a layer-by-layer, non-uniform lysis process. They cannot completely degrade a solid thrombus into ultrafine molecules that can be metabolized by the body's microcirculation in a single step. Instead, they gradually disintegrate the fibrin network of the thrombus, causing it to fragment and become loose, producing a large number of solid thrombus fragments of varying sizes. Simultaneously, mechanical disturbances such as drug flushing, catheter fine-tuning, and blood flow impact further exacerbate thrombus detachment and fragmentation. Since the lower limb arteries have a unidirectional, forward-flowing structure, some medium to large solid fragments produced after thrombus disintegration are difficult to metabolize in time. These fragments then drift distally along the arterial blood flow, becoming lodged in the small branches of the lower limb arteries such as the dorsalis pedis artery, plantar pedis artery, and toe artery, affecting normal blood circulation.

[0004] Therefore, this invention proposes an integrated device for lower extremity arterial thrombolysis catheters with a distal protective umbrella to solve the above-mentioned problems. Summary of the Invention

[0005] To address the aforementioned issues, this invention provides an integrated lower limb arterial thrombolysis catheter device with a distal protective umbrella for use in lower limb arterial contact thrombolysis surgery. By intercepting thrombus fragments generated during thrombolysis, it prevents fragment drift from causing distal peripheral vascular embolism, achieving integrated targeted thrombolysis and fragment protection, simplifying the surgical procedure, and improving intraoperative safety.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: an integrated device for lower extremity arterial thrombolysis catheter with a distal protective umbrella, comprising an external catheter and a sealing guidewire, characterized in that the distal end of the sealing guidewire is detachably connected to an interception component for capturing debris generated during lower extremity arterial thrombolysis.

[0007] Furthermore, the interception assembly includes a fixed sleeve and an interception net, with the fixed sleeve being detachably connected to the distal surface of the closed guide wire; the interception net is fixedly connected to the surface of the fixed sleeve at its center.

[0008] Furthermore, the fixed sleeve and the distal end of the closed guide wire are connected by threads.

[0009] Furthermore, the interceptor net is made of nickel-titanium alloy.

[0010] Furthermore, when the interception net is opened, it takes the shape of a funnel, and the opening of the interception net faces the proximal end of the closed guide wire.

[0011] Furthermore, when the interception net is expanded, the aperture of the interception net is 100–500 μm.

[0012] Furthermore, one end of the interceptor net is fixedly connected to a traction and recovery assembly for retrieving the interceptor net into the outer conduit.

[0013] Furthermore, the traction recovery assembly includes several traction lines fixedly connected to the interception net, with the ends of the traction lines away from the interception net fixedly connected to the surface of the fixed sleeve.

[0014] Furthermore, the traction lines are distributed in a circumferential array along the interception net.

[0015] Furthermore, the traction lines are all made of nickel-titanium alloy.

[0016] The above-mentioned approach offers the following advantages: This approach integrates the thrombolytic occlusion guidewire and the interception component into a single structure. The overall insertion procedure follows the conventional thrombolytic catheter. The interception net, in its retracted state, is simultaneously delivered within the external catheter, eliminating the need for additional punctures to insert a separate protective shield. This simplifies the surgical procedure, reduces intraoperative instrument changes, and lowers the risk of dissection and intimal damage caused by repeated vascular manipulation. The interception net, made of nickel-titanium alloy, automatically expands into a funnel shape after catheter delivery due to shape memory effect, with the opening facing the blood flow direction. This captures thrombus fragments generated during thrombolysis, and the dissolved thrombus forms a secondary embolism in the distal portion. Furthermore, the fixing cannula and occlusion guidewire are connected by a threaded, detachable connection, facilitating the replacement of the interception net with a suitable size according to the vessel diameter, thus adapting to the surgical needs of different segments of the lower limb vessels. The traction and retrieval assembly consists of circumferentially evenly arranged nickel-titanium alloy traction wires. When the guidewire is retracted, the interception net can be evenly gathered, which can collect the captured thrombus fragments into the external catheter and bring them out together. This achieves fragment interception and retrieval, reducing complications (secondary embolism) during lower extremity thrombolysis from the source, reducing subsequent rescue interventions, and improving surgical safety and treatment efficiency.

[0017] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0018] Figure 1 This is an overall schematic diagram of an embodiment of the integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella of the present invention;

[0019] Figure 2 for Figure 1 Enlarged view of section A;

[0020] Figure 3 This is a schematic diagram of the sealing guidewire and interception assembly of an embodiment of the integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella of the present invention;

[0021] Figure 4 for Figure 3 Enlarged view of section B;

[0022] Figure 5 This is a schematic diagram of the fixing sleeve and intercepting net of an embodiment of the integrated device for lower extremity arterial thrombolysis catheter with distal protective umbrella of the present invention;

[0023] Figure 6 This is a schematic diagram of the distal end of the closed guidewire in an embodiment of the integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella of the present invention.

[0024] The reference numerals in the accompanying drawings of the instruction manual include: 1, closed guidewire; 2, external guide tube; 3, interception assembly; 301, fixing sleeve; 302, traction line; 303, interception net. Detailed Implementation

[0025] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0027] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0028] The following detailed description illustrates the specific implementation methods:

[0029] Example 1:

[0030] like Figure 1 As shown, an integrated device for lower extremity arterial thrombolysis catheters with distal protection includes an external catheter 2 and a sealing guidewire 1. The above structure is based on the existing multi-side hole thrombolysis catheters as the basic structure of this solution. Targeted drug infusion is performed by relying on the side holes of the original catheter sidewall. The sealing guidewire 1 is used to block the end hole at the top of the catheter to ensure that the thrombolytic drug acts concentrated on the thrombus lesion area.

[0031] In response to the issue that during lower extremity arterial thrombolysis, medium to large-diameter debris generated from thrombus lysis is prone to drift with the blood flow and subsequently form secondary embolisms, this solution provides an interception component 3, specifically, combined with... Figure 2 , Figure 3 , Figure 4 , Figure 5 and Figure 6 As shown, the interception component 3 includes a fixing sleeve 301, on the surface of which an interception net 303 is integrally formed. The interception net 303 is made of nickel-titanium alloy and, relying on the shape memory effect of the material, completely adheres to the surface of the fixing sleeve 301 in its folded state. It is simultaneously delivered inside the external catheter 2 along with the fixing sleeve 301, and autonomously expands and shapes itself at body temperature after exiting the external catheter 2. When the interception net 303 is expanded, it forms a funnel shape with its opening facing the proximal end of the guidewire 1, aligning with the direction of blood flow to maximize the capture of downstream thrombus fragments. Furthermore, the connection point between the fixing sleeve 301 and the interception net 303 is located at the center of the interception net 303, ensuring that the force on the interception net 303 is centered after expansion, preventing eccentric displacement and ensuring conformity to the blood vessel lumen.

[0032] Specifically, a plurality of intercepting nets 303 are integrally formed on one side near the proximal end of the closed guide wire 1, and a plurality of traction wires 302 (more than four in number) are distributed in a circumferential array to ensure that the intercepting nets 303 can be smoothly retracted during the retraction process, and to avoid deformation of the filter or snagging on the blood vessel wall caused by unilateral force; the ends of the traction wires 302 away from the intercepting nets 303 are all welded to the surface of the fixed sleeve 301, and the traction wires 302 are all made of nickel-titanium alloy.

[0033] In addition, the distal surface of the conventional occlusion guidewire 1 is threaded (facilitating torque transmission and precise thrombus penetration through rotational control). Based on this threaded structure, the fixing sleeve 301 is threadedly connected to the distal thread of the occlusion guidewire 1, making disassembly and assembly simple and the connection secure. This allows medical staff to quickly change the outer diameter and orifice size of the interceptor net 303 according to the actual diameter of different lower limb arteries such as the iliac artery, superficial femoral artery, and popliteal artery. During the operation, after the occlusion guidewire 1 completes the occlusion of the external catheter 2 end hole, the interceptor net 303 is located downstream of the thrombus in the blood flow direction, which is the inevitable path for thrombus fragments to drift with the blood flow. This allows it to capture solid fragments that have detached from thrombolysis in the first instance, conforming to the physical positional logic of fragment interception and subsequent overall recovery.

[0034] In this scheme, the distal end of the sealing guidewire 1 is the sealing head of the sealing guidewire 1.

[0035] The specific implementation process is as follows: Before the operation, based on the diameter of the lesion vessel in the patient's lower limb, a suitable size of interceptor net 303 is selected. The threaded fixing sleeve 301 is tightened and assembled onto the distal end of the sealing guidewire 1, completing the integrated pre-assembly. At this time, the interceptor net 303 completely closes up and adheres to the outer wall of the fixing sleeve 301, relying on the deformation characteristics of the nickel-titanium alloy itself. During the operation, an interventional access is established by lower limb artery puncture. The external catheter 2 is delivered along the vascular access (guided by a super-slippery guidewire) so that the treatment segment of the external catheter 2 is aligned with the thrombus location. After the external catheter 2 is in place, the sealing guidewire 1 is pushed so that the distal end of the sealing guidewire 1 blocks the tip hole of the external catheter 2, completing the drug delivery seal. At this time, the interceptor net 303 is also in place simultaneously. After contacting human blood, the body temperature triggers a phase change and the interceptor net 303 expands spontaneously into a funnel shape, adhering to the inner wall of the blood vessel and establishing a debris interception barrier downstream of the thrombus. Subsequently, an external micro-infusion pump was connected, and thrombolytic drugs were continuously infused through the side holes of the external catheter 2 to carry out targeted thrombolysis. During the thrombolysis process, the debris generated by the thrombus disintegration moved with the forward blood flow. All medium and large-diameter debris was intercepted by the funnel-shaped intercepting net 303, avoiding distal vascular embolism. After the thrombolysis was completed and the angiography confirmed that the blood vessel was patent, the occlusive guidewire 1 was withdrawn. Relying on the circumferentially deployed traction line 302, the intercepting net 303 was evenly pulled together, and the intercepting net 303, along with the thrombus debris captured inside, was collected into the external catheter 2. Finally, the external catheter 2 was withdrawn from the lower limb blood vessel, completing the entire thrombolysis procedure.

[0036] Example 2:

[0037] The difference from Example 1 is that when the interceptor 303 is opened, the aperture of the interceptor 303 is 100-500μm. It can intercept large-diameter thrombus fragments (those smaller than 100μm can be cleared by the body's metabolic mechanism) and reduce the occurrence of secondary embolism at the distal end. It can also allow blood cells, plasma and other blood components to pass through freely, ensuring smooth blood flow in the main trunk and avoiding blood stasis caused by the filter. At the same time, it reduces the adhesion and blockage of the filter by small impurities, taking into account both the safety of thrombolysis and the effect of fragment protection, and is suitable for various degrees of lower limb arterial thrombolysis surgery.

[0038] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An integrated device for lower extremity arterial thrombolysis catheters with distal protective umbrellas, comprising an external catheter (2) and a sealing guidewire (1), characterized in that, The distal end of the closed guidewire (1) is detachably connected to an interception component (3) for capturing debris generated during thrombolysis in the lower extremity arteries.

2. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 1, characterized in that, The interception assembly (3) includes a fixed sleeve (301) and an interception net (303). The fixed sleeve (301) is detachably connected to the distal surface of the closed guide wire (1). The interception net (303) is fixedly connected to the surface of the fixed sleeve (301) at its center.

3. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 2, characterized in that, The fixed sleeve (301) and the far end of the closed guide wire (1) are threaded together.

4. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 3, characterized in that, The interceptor (303) is made of nickel-titanium alloy.

5. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 4, characterized in that, When the interceptor net (303) is opened, the interceptor net (303) is funnel-shaped and the opening of the interceptor net (303) faces the proximal end of the closed guide wire (1).

6. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 5, characterized in that, When the intercepting net (303) is opened, the aperture of the intercepting net (303) is 100-500μm.

7. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 6, characterized in that, One end of the intercepting net (303) is fixedly connected to a traction recovery assembly for recovering the intercepting net (303) into the outer conduit (2).

8. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 7, characterized in that, The traction recovery assembly includes several traction lines (302) that are fixedly connected to the interception net (303). The ends of the traction lines (302) away from the interception net (303) are all fixedly connected to the surface of the fixed sleeve (301).

9. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 8, characterized in that, The traction line (302) is distributed in a circumferential array along the interception net (303).

10. The integrated lower extremity arterial thrombolysis catheter device with distal protective umbrella according to claim 9, characterized in that, The traction lines (302) are all made of nickel-titanium alloy.

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