Varicosity treatment device

Abstract

The invention relates to the technical field of medical instruments, in particular to a varicosity treatment device which comprises an inner catheter and an outer catheter, the inner catheter is sleeved with the outer catheter in a sliding mode, a blocking balloon is arranged at the head end of the inner catheter, a medicine outlet hole is formed in the head end of the outer catheter, and a blood discharging balloon and a membrane puncturing assembly are sequentially arranged at the end, close to the medicine outlet hole, of the outer catheter. The membrane puncturing assembly is used for mechanically scratching a vein wall membrane. The vascular wall intima is scratched in the blood vessel through the membrane puncturing assembly, the drug barrier is broken, and the permeation efficiency and the treatment effect of the hardening agent are improved. By arranging the blood discharge balloon on the outer catheter, the blood in the target vein section can be temporarily discharged before the hardening agent is injected, so that the dilution of the medicine by the blood is avoided, and the effective concentration and the acting effect of the medicine are further ensured. The technical problems that in the prior art, the vascular wall membrane cannot be mechanically damaged, the blood discharging function cannot be achieved, the reaction efficiency of a hardening agent and the vascular wall is reduced, and then the treatment effect is reduced are solved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a varicose vein treatment device. BACKGROUND

[0002] Varicose veins are a very common chronic venous insufficiency disease, which refers to the enlargement, swelling and twisting of veins, appearing blue or deep purple. It is caused by circulatory system disorders, with defective valves in the veins leading to blood flowing in the wrong direction or "accumulation", with a high incidence of nearly 10%.

[0003] Varicose vein sclerosing agents are a minimally invasive treatment method that closes varicose veins by injecting chemical drugs, commonly used to improve mild to moderate varicose veins. The core principle is to inject foam sclerosing agents and other drugs into diseased blood vessels to induce endovascular inflammation, ultimately forming fibrosis to close the blood vessels.

[0004] Traditional varicose vein treatment methods have certain limitations, for example, surgical stripping surgery has a large trauma, a long postoperative recovery time, and may leave scars. Laser or radiofrequency ablation and other thermal ablation techniques have certain effects, but may cause skin burns, nerve damage and other complications. Sclerotherapy is a chemical ablation that destroys the lining of the internal vein, leading to the collapse and closure of the vein over time. Compared with thermal ablation, the patient's experience is better, but due to the dilution of the sclerosing agent mixed with blood, the treatment effect is affected, and without protective measures, the sclerosing agent can easily enter the deep veins to induce thrombosis, and may also cause inflammation and other adverse reactions, resulting in poor results. The efficacy of thermal ablation is 90%, but the efficacy of sclerotherapy is only 50-80%.

[0005] According to the search, the Chinese patent with the authorization announcement number CN 221617129 U discloses a great saphenous vein varicose sclerosing agent treatment device, which comprises a three-way pipe, an air pipe and a two-end closed connecting pipe; the three-way pipe is detachably connected with a gas supply pipe and a dosing pipe, and is fixedly connected with a infusion pipe, the connecting pipe is fixedly connected with the infusion pipe, and an outside is provided with a blocking air bag, the connecting pipe is communicated with the blocking air bag, the air pipe is located in the three-way pipe and the infusion pipe, and is communicated with the connecting pipe and the gas supply pipe, and the infusion pipe is provided with a discharge hole.

[0006] The above-mentioned prior art can solve the problem of sclerosing agent entering the deep veins to induce thrombosis, but cannot realize the mechanical damage to the blood vessel wall membrane and the blood discharge function, reducing the efficiency of the sclerosing agent and the blood vessel wall fully contacting reaction, and further reducing the effect of sclerosing agent treatment. SUMMARY

[0007] Based on the problems existing in the prior art, the present application aims to provide a treatment device which can effectively destroy the intima barrier of the blood vessel wall and has blood discharge function, so as to ensure that the sclerosing agent drug fully acts and blocks the entry into the deep vein, thereby improving the treatment effect, and the device is simple to operate and has small trauma.

[0008] To achieve the above-mentioned purpose, the present application adopts the following technical solutions: The present application provides a varicose vein treatment device, which comprises an inner catheter and an outer catheter, the inner catheter is sleeved in the outer catheter, the head end of the inner catheter is provided with a blocking balloon, the head end of the outer catheter is provided with a drug outlet hole, and a blood discharge balloon and a membrane piercing assembly are sequentially arranged on the outer catheter near the drug outlet hole, and the membrane piercing assembly is used for mechanically breaking the membrane of the vein blood vessel wall.

[0009] In detail, the inner catheter wall is provided with a ventilation hole communicating with the blocking balloon, which is used for inflating the blocking balloon to make the blocking balloon expand, so as to realize the fixation of the inner catheter and the blocking of the blood vessel, and effectively prevent the sclerosing agent from entering the deep vein to induce thrombosis.

[0010] Further, the membrane piercing assembly comprises a fixed seat fixedly sleeved on the outer catheter and a sliding seat slidably sleeved on the outer catheter, a plurality of support rods are rotatably connected to the fixed seat at intervals, a plurality of connecting rods are rotatably connected to the sliding seat at intervals, and the connecting rods and the support rods are correspondingly matched to realize the unfolding and folding of the membrane piercing assembly.

[0011] Further, the membrane piercing assembly further comprises a membrane piercer arranged at the head end of each connecting rod, and the membrane piercer can extend outward to contact and pierce the blood vessel intima when the membrane piercing assembly is unfolded.

[0012] Further, an adjusting groove is formed through the connecting rod, and the end of the support rod slides in the adjusting groove.

[0013] Further, a plurality of limiting grooves are arranged on the outer wall of the outer catheter at intervals, and a plurality of limiting blocks are arranged on the inner side of the sliding seat at intervals, and the limiting blocks and the limiting grooves are slidably matched.

[0014] In detail, the limiting grooves and the limiting blocks are both in "T" shape structure, and the limiting blocks and the limiting grooves form a sliding fit, which can not only ensure the smooth movement of the sliding seat along the outer catheter in the axial direction, but also prevent the circumferential rotation of the sliding seat, thereby ensuring the accuracy and stability of the action of the membrane piercing assembly.

[0015] Further, a group of push-pull rods are connected to the bottom of the sliding seat, the end of the push-pull rod is connected with a push-pull ring, and the push-pull ring is slidably sleeved on the outer catheter. By pushing or pulling the push-pull ring forward or backward, the unfolding and folding of the membrane piercing assembly can be remotely controlled, which is convenient to operate.

[0016] Furthermore, the external catheter is equipped with an inflation tube for inflating the blood-emptying balloon, thereby enabling the expansion and contraction of the blood-emptying balloon.

[0017] Furthermore, the technical solution includes a sealing head at the tail end of the inner catheter. This sealing head is used to close the tail end of the inner catheter and allows it to be connected to a syringe or other drug delivery device.

[0018] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention integrates mechanical puncture membrane and drug perfusion functions. By directly damaging the thickened or diseased vascular intima inside the blood vessel through the puncture membrane component, it breaks the drug barrier, significantly improves the penetration efficiency and therapeutic effect of drugs such as sclerosing agents, and is expected to reduce the recurrence rate.

[0019] 2. By placing a blood-draining balloon on the external catheter, the present invention can temporarily drain the blood in the target venous segment before injecting the sclerosing agent, avoiding the dilution of the drug by the blood and further ensuring the effective concentration and effect of the drug.

[0020] 3. This invention uses an axially pushing and pulling ring to drive the sliding seat to move up and down along the axial direction of the external catheter. The radial expansion and contraction of the puncture membrane assembly can be controlled by the cooperation of the support rod and the connecting rod. When the puncture membrane assembly expands, it causes the puncture device to evenly contact the blood vessel wall membrane, ensuring a good puncture effect. When the puncture membrane assembly contracts, it facilitates the complete removal of the device from the blood vessel. This application has an ingenious structure and is simple and reliable to operate.

[0021] 4. This invention can enter blood vessels through minimally invasive intervention, resulting in less trauma, faster patient recovery, and precise and efficient treatment. Attached Figure Description

[0022] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0023] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 For the present invention Figure 1 A three-dimensional image; Figure 3 This is a three-dimensional view of the internal catheter of the present invention; Figure 4 For the present invention Figure 3 Vertical sectional view; Figure 5It is a structure perspective view of the outer catheter of the present application; Figure 6 It is a transverse sectional view of the present application Figure 5 ; Figure 7 It is a structure perspective view of the puncture membrane assembly of the present application Figure 8 It is an enlarged view of A part in the present application Figure 7 ; In the figure: 1, inner catheter; 2, outer catheter; 3, occlusion balloon; 4, medicine outlet hole; 5, blood discharge balloon; 6, puncture membrane assembly; 601, fixing seat; 602, sliding seat; 603, support rod; 604, connecting rod; 605, puncture membrane device; 606, adjusting groove; 7, limiting groove; 8, limiting block; 9, push-pull rod; 10, push-pull ring; 11, inflation tube; 12, occlusion head. DETAILED DESCRIPTION

[0024] Example implementations will now be described more fully with reference to the accompanying drawings. Example implementations may, however, be implemented in many different forms and should not be construed as limited to the examples set forth herein; rather, these example implementations are provided so that this disclosure will be thorough and complete, and will fully convey the concept of example implementations to those skilled in the art. Accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and serve to explain the principles of the present disclosure. Like reference numerals refer to like elements throughout.

[0025] Moreover, the described features, structures, or characteristics can be combined in any suitable manner in one or more example implementations. In the following description, numerous specific details are provided to give a thorough understanding of example implementations of the present disclosure. One skilled in the relevant art will recognize, however, that the

[0026] Embodiment one Referring to Figures 1-2 the drawings, the present application provides a varicose vein treatment device, which mainly comprises an inner catheter 1 and an outer catheter 2 to form a core catheter system. The inner catheter 1 is sleeved in the inner part of the outer catheter 2 in a sliding manner. An occlusion balloon 3 is arranged at the head end (i.e. the distal end extending into the blood vessel) of the inner catheter 1. The occlusion balloon 3 can be inflated and deflated through the lumen of the inner catheter 1, which is used to block the hardened agent from entering the deep vein to induce thrombosis at the distal end of the target vein segment.

[0027] As an example, referring to Figure 3As shown, the inner catheter 1 has a vent hole on its wall that connects to the occlusion balloon 3, which is used to inflate the occlusion balloon 3, thereby fixing the inner catheter 1 and occluding the blood vessel.

[0028] Reference Figure 5 As shown, the external catheter 2 has several drug outlet holes 4 at its tip to uniformly release drugs (such as sclerosing agents) into the target venous segment to induce a reaction. Furthermore, the external catheter 2 is provided with a blood drainage balloon 5 and a puncture membrane assembly 6 arranged sequentially from its tip to its tail.

[0029] As an example, the external catheter 2 is provided with an inflation tube 11 for inflating the drainage balloon 5. When it inflates, it can block proximal blood flow and together with the distal occlusion balloon 3, form a closed treatment area. By moving the external catheter 2, the drainage balloon 5 can be moved to empty the blood in this area.

[0030] Reference Figures 7-8 As shown, to create a penetration channel for the sclerosing agent, a puncture device 6 is provided on the external catheter 2. The puncture device 6 is used to mechanically puncture the intima of the vein wall inside the blood vessel. Its specific structure includes: a fixed seat 601 fixedly sleeved on the outer wall of the external catheter 2, and a sliding seat 602 that can slide axially along the outer wall of the external catheter 2. Multiple support rods 603 are circumferentially and evenly hinged to the fixed seat 601. Correspondingly, multiple connecting rods 604 are circumferentially and evenly hinged to the sliding seat 602, the number of connecting rods 604 being the same as and corresponding one-to-one with the support rods 603. A puncture device 605 is installed at the tip of each connecting rod 604.

[0031] As an example, the puncture device 605 may be a tiny blade, needle tip, wire, or rough friction head.

[0032] Furthermore, an elongated adjustment groove 606 is provided on the body of the connecting rod 604, and the end of the corresponding support rod 603 is embedded in the adjustment groove 606 and can slide along the groove.

[0033] The sliding seat 602 drives the connecting rod 604 to unfold and retract with the cooperation of the support rod 603. After the connecting rod 604 unfolds, it drives the puncture device 605 to evenly contact the blood vessel wall membrane, ensuring the membrane scribing effect. After the connecting rod 604 retracts, it is easy for the whole device to be withdrawn from the blood vessel.

[0034] To ensure that the sliding seat 602 can only move axially and not rotate, an axial limiting groove 7 is provided on the outer wall of the outer guide tube 2, and a protruding limiting block 8 is provided on the inner side of the sliding seat 602. The limiting block 8 is embedded in the limiting groove 7 to form a sliding limit.

[0035] Example 2 Based on Example 1, referring to Figures 1-2 , Figure 7 As shown, to facilitate remote control of the deployment and retraction of the puncture membrane assembly 6 outside the blood vessel, a push-pull rod 9 is connected to the tail of the sliding seat 602. A push-pull ring 10 is fixed to the tail end of the push-pull rod 9, and the push-pull ring 10 is slidably fitted onto the external catheter 2. The operator can move the sliding seat 602 by pushing the push-pull ring 10 forward (towards the head end) or pulling it backward (towards the tail end).

[0036] As an example, to prevent the sliding seat 602 from shifting after the position is adjusted, a rubber ring is provided on the inner side of the push-pull ring 10 to increase the friction between the push-pull ring 10 and the outer guide tube 2, so that the push-pull ring 10 can only slide when pushed or pulled by the operator.

[0037] Preferably, a sealing head 12 is provided at the tail end of the inner catheter 1 to seal the tail end of the inner catheter 1, and the sealing balloon 3 can be inflated or deflated through the sealing head 12. At the same time, the tail end of the outer catheter 2 can be used to connect a syringe for drug injection.

[0038] Specific application process The specific application of a varicose vein treatment device of this application in sclerotherapy for varicose veins is now described in detail with reference to Embodiment 1 and Embodiment 2.

[0039] Sclerotherapy is a medical technique that uses injected chemical drugs to stimulate tissue fibrosis for therapeutic purposes. Guided by imaging equipment, this therapy allows for precise punctures and visualized injection procedures, offering greater safety compared to traditional visual methods. Based on their mechanism of action, sclerosing agents can be categorized into three types: cleansing agents, penetrating agents, and chemical agents. A derivative technique, scleroembolization, uses catheter-based intervention to achieve both lesion sclerotherapy and vascular embolization, providing a dual therapeutic effect.

[0040] Sclerotherapy for varicose veins is a minimally invasive interventional therapy that involves injecting a chemical drug (sclerosing agent) into the varicose veins, causing an inflammatory response and closure, which is eventually absorbed by the body. The mechanism of action is that after the sclerosing agent is injected into the blood vessel, it destroys the endothelial cells, causing the blood vessel wall to adhere and close, diverting blood to healthy veins.

[0041] To facilitate a better reaction of the sclerosing agent in the veins and enhance its therapeutic effect, this application provides a varicose vein treatment device, which is used as follows: Under ultrasound guidance, the device is inserted into the target varicose vein segment. First, the distal occlusion balloon 3 is inflated through the inner catheter 1, causing it to expand and block the distal end of the vein. Then, the blood-expelling balloon 5 is inflated through the inflation tube 11, causing it to expand and block the proximal end of the vein, forming a closed chamber between the two balloons.

[0042] Next, the operator pulls the push-pull ring 10 backward, which drives the sliding seat 602 to move proximally via the push-pull rod 10. Since the fixed seat 601 is fixed, the backward movement of the sliding seat 602 causes the linkage mechanism consisting of the support rod 603 and the connecting rod 604 to move. The end of the support rod 603 slides in the adjustment groove 606 of the connecting rod 604, forcing the connecting rod 604 and the puncture device 605 at its head end to extend radially outward until the puncture device 605 contacts and slightly punctures the inner lining of the vein.

[0043] After the puncture is completed, the push-pull ring 10 is pushed forward to retract the puncture assembly 6. Then, the blood drainage balloon is pulled to keep the injection area in a draining state, and a predetermined dose of sclerosing agent or other therapeutic drugs is injected through the tail end of the external catheter 2. The drug flows out through the drug outlet 4 at the tip and acts directly on the vessel wall whose intima has been punctured, ensuring full penetration and efficacy of the drug.

[0044] After the injection is complete, deflate and retract the evacuation balloon 5 and the occlusion balloon 3 in sequence. Finally, remove the entire device from the vein to complete the treatment.

[0045] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

[0046] Finally, the following points should be noted: First, in the description of this application, it should be noted that, unless otherwise specified and limited, the terms "installation", "connection", and "linkage" should be interpreted broadly, and can be mechanical or electrical connections, or internal connections between two components, or direct connections. "Up", "down", "left", "right", etc. are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may change. Secondly: The accompanying drawings of the embodiments disclosed in this invention only involve the structures involved in the embodiments disclosed in this invention. Other structures can refer to the general design. In the absence of conflict, the same embodiment and different embodiments of this invention can be combined with each other. In conclusion, the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

[0047] [1] These are transitional words used in the patent document drafting process and do not affect the technical solution.

Claims

1. A varicose vein treatment device comprising an inner catheter (1) and an outer catheter (2), characterized in that: The inner catheter (1) is slidingly sleeved in the outer catheter (2), the head end of the inner catheter (1) is provided with a blocking balloon (3), the head end of the outer catheter (2) is provided with a medicine outlet hole (4), the medicine outlet hole (4) is provided with a blood discharge balloon (5) and a membrane puncturing assembly (6) in sequence from the proximal end of the medicine outlet hole (4) on the outer catheter (2), and the membrane puncturing assembly (6) is used for mechanically puncturing the membrane of a vein blood vessel wall.

2. A varicose vein treatment device according to claim 1, characterised in that: The membrane puncturing assembly (6) comprises a fixed seat (601) fixedly sleeved on the outer catheter (2) and a sliding seat (602) slidingly sleeved on the outer catheter (2), a plurality of support rods (603) are rotatably connected to the fixed seat (601) in a spaced manner, and a plurality of connecting rods (604) are rotatably connected to the sliding seat (602) in a spaced manner, and the connecting rods (604) and the support rods (603) are correspondingly matched.

3. A varicose vein treatment device according to claim 2, wherein: The membrane puncturing assembly (6) further comprises a membrane puncturing device (605) arranged at the head end of each connecting rod (604).

4. A varicose vein treatment device according to claim 2 or 3, characterised in that: An adjusting groove (606) is formed through the connecting rod (604), and the end of the support rod (603) slides in the adjusting groove (606).

5. A varicose vein treatment device according to claim 4, wherein: A plurality of limiting grooves (7) are arranged on the outer wall of the outer catheter (2) in a spaced manner, and a plurality of limiting blocks (8) are arranged on the inner side of the sliding seat (602) in a spaced manner, and the limiting blocks (8) and the limiting grooves (7) are slidingly matched.

6. A varicose vein treatment device according to claim 5, wherein: A group of push-pull rods (9) are connected to the bottom of the sliding seat (602), the end of the push-pull rod (9) is connected with a push-pull ring (10), and the push-pull ring (10) is slidingly sleeved on the outer catheter (2).

7. The varicose vein treatment device of claim 1, wherein: An inflation pipe (11) for inflating the blood discharge balloon (5) is arranged on the outer catheter (2).

8. The varicose vein treatment device of claim 1, wherein: The tail end of the inner catheter (1) is provided with a blocking head (12).

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