Two-component liquid conveying microcatheter

Abstract

The microcatheter comprises an inner tube and an outer tube which are coaxially arranged, the outer tube wraps the inner tube, a side hole is formed in the near end of the outer tube, and the inner tube extends out of the side hole to form a forked structure; a gap is formed between the outer tube and the inner tube, and the gap and the inner tube are separated to form two-component infusion channels which are isolated from each other. According to the invention, two component liquid substances can be independently conveyed at the same time, are converged at a treatment target at the far end of the catheter and then are subjected to in-situ polymerization to form gel, so that the gel enters a finer blood vessel branch, and comprehensive and thorough embolism treatment is carried out on tumor tissues; the adjusting knob is rotated to drive the sliding block to extrude or release extrusion on the balloon, so that the total volume of the infusion channel of the outer tube is changed, and finally the flow ratio of different component liquid substances at the far end of the catheter is adjusted. The conveying micro-catheter can be used in cooperation with a conventional duplex injector, the output end of the catheter outputs liquid substances with different components at the same time, two kinds of liquid are mixed more evenly, and meanwhile the operation steps of a doctor are effectively reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to a two-component liquid delivery microcatheter. Background Art

[0002] Transcatheter arterial chemoembolization (TACE) is a minimally invasive interventional therapy. It involves selectively inserting a catheter into the target artery supplying the tumor and injecting an appropriate amount of embolic agent to block the tumor's blood supply, causing ischemic necrosis of the tumor tissue. This procedure, characterized by minimal trauma and proven efficacy, is suitable for patients with unresectable liver cancer or as an adjunctive treatment prior to liver cancer surgery. It can, to a certain extent, control tumor progression and prolong patient survival. The choice of embolic agent is crucial in TACE, as embolic agents rely on blood coagulation to achieve embolization. In patients with poor coagulation function, embolization may be incomplete, potentially leading to accidents.

[0003] Currently, commonly used embolic agents mainly include iodized oil, gelatin sponge and microspheres. The overall operation steps are relatively complicated and cannot fully meet clinical needs: although iodized oil can embolize the end of the blood vessel, its retention time in the body is short and it will gradually be absorbed or metabolized over time; although gelatin sponge and microspheres can effectively block larger blood vessels, due to their relatively fixed size, it is difficult to enter smaller blood vessel branches, and cannot perform comprehensive and thorough embolization of tumor tissue. They are also prone to drift to non-target areas with the blood flow, causing ectopic embolism, leading to ischemia of normal tissues and organs, and triggering a series of complications. Summary of the Invention

[0004] The purpose of the present invention is to solve the shortcomings of the prior art and to propose a two-component liquid delivery microcatheter.

[0005] In order to achieve the above object, the present invention provides a two-component liquid delivery microcatheter, comprising:

[0006] An inner tube and an outer tube are coaxially arranged, wherein the outer tube is wrapped around the inner tube, a side hole is opened at the proximal end of the outer tube, and the inner tube extends out of the side hole to form a bifurcated structure;

[0007] A gap is formed between the outer tube and the inner tube, and the gap and the inner tube are separated to form mutually isolated two-component infusion channels.

[0008] In some embodiments, the inner tube includes a first proximal end and a first distal end, and the outer tube includes a second proximal end and a second distal end.

[0009] In some embodiments, the first distal end and the second distal end are flush with each other.

[0010] In some embodiments, the first distal end extends beyond the second distal end by 0-10 mm.

[0011] In some embodiments, the first distal end is sleeved with a first developing ring, and the second distal end is sleeved with a second developing ring.

[0012] In some embodiments, handles are provided on the outside of the first proximal end and the second proximal end, and a stress tube is provided on the distal end of the handle, and the stress tube abuts against the middle portion of the exterior.

[0013] In some embodiments, the second proximal end is connected to a balloon, and a slider is provided on one side of the balloon, and the slider squeezes the balloon to adjust the flow ratio of the two-component infusion channel.

[0014] In some embodiments, an adjustment knob is provided on one side of the handle, and the adjustment knob is rotatably connected to the slider.

[0015] In some embodiments, a mounting port is provided at the proximal end of the handle, and the first infusion tube and the second infusion tube are detachably mounted on the mounting port.

[0016] In some embodiments, the first proximal end is communicated with a first infusion tube, the second proximal end is communicated with a distal end of the balloon, and the proximal end of the balloon is communicated with a second infusion tube.

[0017] The present invention has the following beneficial effects:

[0018] 1. In the present invention, the coaxially arranged inner and outer tubes form a mutually isolated dual-component infusion channel, capable of simultaneously and independently delivering two liquid components without interfering with each other during delivery. The two components ultimately converge at the therapeutic target site at the distal end of the catheter and polymerize in situ to form a gel, thereby entering smaller vascular branches and providing comprehensive and thorough embolization therapy for tumor tissue.

[0019] 2. In the present invention, a balloon is connected to the proximal end of the outer tube, and a slider is provided on one side of the balloon. By rotating the adjustment knob provided on the outside of the handle, the slider is driven to squeeze or release the balloon, thereby changing the total volume of the infusion channel of the outer tube, and ultimately adjusting the flow ratio of different components of liquid substances at the distal end of the catheter.

[0020] 3 In the present invention, the delivery microcatheter can be used in conjunction with a conventional double syringe. The output end of the catheter simultaneously outputs liquid substances of different components, making the two liquids mix more evenly while effectively reducing the doctor's operation steps, thereby meeting the clinical operational requirements for the volume ratio of two components for two-component embolic hydrogel / two-component drug delivery. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1Schematic diagram of the structure of the two-component liquid delivery microcatheter proposed in the present invention Figure 1 ;

[0022] Figure 2 Schematic diagram of the structure of the two-component liquid delivery microcatheter proposed in the present invention Figure 2 ;

[0023] Figure 3 for Figure 2 Schematic cross-sectional view at AA in the middle;

[0024] Figure 4 for Figure 2 The enlarged schematic diagram of point I in the middle;

[0025] Figure 5 for Figure 3 The enlarged schematic diagram of the middle part Ⅱ;

[0026] Figure 6 for Figure 4 Schematic cross-sectional view at the middle BB.

[0027] Legend:

[0028] 1. Inner tube; 101. First proximal end; 102. First distal end; 2. Outer tube; 201. Second proximal end; 202. Second distal end; 3. First developing ring; 4. Second developing ring; 5. Handle; 501. Mounting port; 6. Stress tube; 7. Balloon; 8. Slider; 9. Adjustment knob; 10. First infusion tube; 11. Second infusion tube. DETAILED DESCRIPTION

[0029] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0030] The embodiments of the present application provide a two-component liquid delivery microcatheter, which solves the problem that iodized oil, one of the embolic agents commonly used in the prior art, can embolize the ends of blood vessels but has a short retention time in the body and is gradually absorbed or metabolized over time; and that gelatin sponges and microspheres, although they can effectively block larger blood vessels, have difficulty entering smaller blood vessel branches due to their relatively fixed size, making it impossible to fully and thoroughly embolize tumor tissue. Moreover, they are easily transferred to non-target areas with the blood flow, causing ectopic embolism, leading to ischemia of normal tissues and organs, and triggering a series of complications. The present application forms an isolated two-component infusion channel by separating the inner tube and the outer tube arranged coaxially, which can separately deliver two components of liquid substances at the same time, and the two components will not meet and interfere with each other during the delivery process. Finally, they will converge at the treatment target at the distal end of the catheter and polymerize in situ to form a gel, thereby performing embolization treatment; and the delivery microcatheter can be used in conjunction with a conventional double syringe. The output end of the catheter simultaneously outputs liquid substances of different components, making the two liquids mix more evenly while effectively reducing the doctor's operation steps, thereby meeting the clinical operational requirements for the volume ratio of two components for two-component embolic hydrogel / two-component drug delivery.

[0031] Please refer to the following examples for details:

[0032] Reference Figure 1 The present invention provides an embodiment of a two-component liquid delivery microcatheter, the specific structure of which includes: a coaxially arranged cylindrical inner tube 1 and an outer tube 2; wherein the outer tube 2 is coated on the outside of the inner tube 1, so that a uniform annular gap can be formed between the inner tube 1 and the outer tube 2;

[0033] Specifically, a side hole is opened at the proximal end of the outer tube 2, and the inner tube 1 extends out of the side hole to form a "Y"-shaped bifurcation structure, and a gap is formed between the outer tube 2 and the inner tube 1. The gap in the side hole is filled and sealed through relevant processes, so that the gap and the inner tube 1 can be separated accordingly to form mutually isolated two-component infusion channels.

[0034] For example, an elliptical side hole can be opened at the proximal end of the outer tube 2 3-5 cm away from the tip, and its long axis forms a 45° angle with the axial direction of the catheter, so that the inner tube 1 can pass through smoothly while reducing the impact on the structural strength of the outer tube 2; and the gap in the side hole can be filled with medical-grade polyurethane elastomer, which achieves nano-level sealing through micro-injection molding process, thereby ensuring sealing reliability.

[0035] It should be explained in detail that hydrogel is a solid substance formed by a polymerization reaction after mixing two liquid substances. When used as an embolic agent, hydrogel is not restricted by the anatomical structure of the blood vessels. Therefore, it can perfectly fill the entire blood vessel that needs embolization, including the small blood vessels at the end. It is a new type of minimally invasive vascular embolization treatment method that allows interventional radiologists to easily achieve immediate, complete and lasting embolization.

[0036] It can be understood that the coaxially arranged inner tube 1 and outer tube 2 are separated to form a mutually isolated two-component infusion channel, which can separately deliver two components of liquid substances at the same time, and the two will not meet and interfere with each other during the delivery process. Finally, they will converge at the treatment target at the distal end of the catheter and polymerize in situ to form a gel, thereby entering smaller blood vessel branches and performing comprehensive and thorough embolization treatment on tumor tissue.

[0037] Furthermore, the inner tube 1 includes a first proximal end 101 and a first distal end 102, and the outer tube 2 includes a second proximal end 201 and a second distal end 202. Specifically, the lengths of the first distal end 102 and the second distal end 202 include the following two situations, so that the position where the embolic material is formed can be determined by the first distal end 102 of the inner tube 1:

[0038] (1) The first distal end 102 and the second distal end 202 are flush with each other: at this time, the liquid substance of component A flowing out of the inner tube 1 and the liquid substance of component B flowing out of the outer tube 2 merge at the treatment target point at the distal end of the catheter and then polymerize in situ to form a gel, thereby performing embolization treatment;

[0039] (2) The first distal end 102 extends beyond the second distal end 202 by a certain distance (specifically 0-10 mm; the time when the liquid substance of component A meets the liquid substance of component B is affected by the specific length that the first distal end 102 of the inner tube 1 extends beyond the second distal end 202 of the outer tube 2, and the specific design can be determined based on actual needs): at this time, the liquid substance of component A flowing out of the inner tube 1 flows out before the liquid substance of component B flowing out of the outer tube 2 for a period of time, and then merges at the treatment target point at the distal end of the catheter and polymerizes in situ to form a gel, thereby performing embolization treatment.

[0040] It can be understood that the flush solution is suitable for scenarios that require rapid in situ polymerization (such as precise embolization of peripheral blood vessels). Doctors can confirm whether the mixing area matches the treatment target through the position of the developing ring to avoid the embolization range exceeding expectations; and the inner tube 1 exceeds the outer tube 2 solution is suitable for embolization needs of blood vessels of different diameters (such as large blood vessel anchoring and directional filling of branch blood vessels). Doctors can accurately control the release time difference between component A and component B according to the relative position of the developing ring, so that the gel forms a specific shape (such as columnar or layered) in the target blood vessel.

[0041] Correspondingly, the first distal end 102 is sleeved with a first developing ring 3, which can directly mark the specific position of the first distal end 102 of the inner tube 1 in the blood vessel, that is, the outflow port of component A, helping doctors to determine whether the release site of component A has reached the treatment target; and the second distal end 202 is sleeved with a second developing ring 4, which can directly mark the specific position of the second distal end 202 of the outer tube 2 in the blood vessel, that is, the outflow port of component B, helping doctors to determine whether the release site of component B has reached the treatment target.

[0042] The correspondingly arranged first developing ring 3 and second developing ring 4 can prevent the microcatheter from being bent, entangled or excessively penetrating into the blood vessel branch, thereby improving operational safety; and the relative position change of the first developing ring 3 and the second developing ring 4 can intuitively reflect the specific extension length of the inner tube 1, providing a visual basis for controlling the mixing time of the two components.

[0043] Please continue reading Figures 1-6 In this embodiment, a handle 5 is provided on the outside of the first proximal end 101 and the second proximal end 201; wherein, a mounting port 501 is provided at the proximal end of the handle 5, and the first infusion tube 10 and the second infusion tube 11 are detachably installed at the mounting port 501; correspondingly, a stress tube 6 is provided at the distal end of the handle 5, and the stress tube 6 is in contact with the middle of the appearance.

[0044] Exemplarily, the mounting port 501 may adopt a Luer lock structure, the inner wall of which is provided with a spiral guide groove, which forms a taper fit with the outer conical surface of the first infusion tube 10 / the second infusion tube 11, and realizes quick locking by rotation; and the stress tube 6 is formed with the middle part of the outer tube 2 through a heat welding process to form a connection structure with a certain pull-off force, which can effectively disperse the bending stress, so that the catheter can still maintain a high flow rate when it is bent.

[0045] Furthermore, the second proximal end 201 is connected to a balloon 7, which expands and deforms slightly under a certain pressure, thereby ensuring the linearity of the flow regulation; and a slider 8 is provided on one side of the balloon 7, so that the slider 8 can adjust the flow ratio of the two-component infusion channel after squeezing the balloon 7; correspondingly, an adjusting knob 9 is provided on one side of the handle 5, and the adjusting knob 9 is rotatably connected to the slider 8, so that when the adjusting knob 9 is rotated by a certain angle, the slider 8 can slide a certain distance accordingly, thereby squeezing or releasing the balloon 7.

[0046] Specifically, the first proximal end 101 is connected to the first infusion tube 10 to form a circulation channel for the liquid substance of component A; and the second proximal end 201 is connected to the distal end of the balloon 7, and the proximal end of the balloon 7 is connected to the second infusion tube 11 to form a circulation channel for the liquid substance of component B.

[0047] It can be understood that by rotating the adjustment knob 9 provided on the outside of the handle 5, the slider 8 can be driven to slide a corresponding distance, thereby squeezing or releasing the balloon 7, thereby changing the total volume of the infusion channel of the outer tube 2, and finally adjusting the flow ratio of different components of liquid substances at the distal end of the catheter; and the delivery microcatheter can be used in conjunction with a conventional double syringe, and the output end of the catheter simultaneously outputs liquid substances of different components, so that the two liquids are mixed more evenly while effectively reducing the doctor's operation steps, thereby meeting the clinical operational requirements for the volume ratio of two components for two-component embolic hydrogel / two-component drug delivery.

[0048] Finally, it should be noted that the above is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or make equivalent substitutions for some of the technical features therein. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A two-component liquid delivery microcatheter, characterized in that: include: An inner tube and an outer tube are coaxially arranged, wherein the outer tube is wrapped around the inner tube, a side hole is opened at the proximal end of the outer tube, and the inner tube extends out of the side hole to form a bifurcated structure; A gap is formed between the outer tube and the inner tube, and the gap and the inner tube are separated to form mutually isolated two-component infusion channels.

2. The two-component liquid delivery microcatheter according to claim 1, characterized in that: The inner tube includes a first proximal end and a first distal end, and the outer tube includes a second proximal end and a second distal end.

3. The two-component liquid delivery microcatheter according to claim 2, characterized in that: The first distal end and the second distal end are flush with each other.

4. The two-component liquid delivery microcatheter according to claim 2, characterized in that: The first distal end extends beyond the second distal end by 0-10 mm.

5. The two-component liquid delivery microcatheter according to claim 2, characterized in that: The first distal end is sleeved with a first developing ring, and the second distal end is sleeved with a second developing ring.

6. The two-component liquid delivery microcatheter according to claim 2, characterized in that: A handle is provided on the outside of the first proximal end and the second proximal end, a stress tube is provided on the distal end of the handle, and the stress tube is in contact with the middle portion of the exterior.

7. The two-component liquid delivery microcatheter according to claim 2, characterized in that: The second proximal end is connected to a balloon, and a slider is provided on one side of the balloon. The slider squeezes the balloon to adjust the flow ratio of the two-component infusion channel.

8. The two-component liquid delivery microcatheter according to claim 6, characterized in that: An adjusting knob is provided on one side of the handle, and the adjusting knob is rotatably connected to the slider.

9. The two-component liquid delivery microcatheter according to claim 6, characterized in that: The proximal end of the handle is provided with a mounting opening, and the first infusion tube and the second infusion tube are detachably mounted on the mounting opening.

10. The two-component liquid delivery microcatheter according to claim 6, characterized in that: The first proximal end is communicated with a first infusion tube, the second proximal end is communicated with a distal end of the balloon, and the proximal end of the balloon is communicated with a second infusion tube.

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