Venous High Closure System and Advanced Mechano-Chemical Ablation System

Abstract

The present invention discloses a mechanical and chemical ablation device for the inner wall of a vein during lower extremity venous surgery. The present invention comprises a catheter consisting of an outer catheter of a flexible material having a predetermined length for insertion into a blood vessel and an inner catheter inserted into the interior of the outer catheter and sliding therein; a stimulating body forming a stimulating layer on the surface of a friction ball formed by twisting several strands of wire tips of an elastic material inserted into the inner catheter spirally to stimulate and damage the inner wall of the vein; an expanding member extending in the longitudinal direction of the inner catheter emerging from the tip of the outer catheter; and a back body having a hook on the surface of a cylindrical tube connected to the expanding member to control movement in the direction of the deep vein, and having a therapeutic agent absorbed by the human body inside.

Description

Technology Field

[0001] The present invention relates to a mechanical and chemical resection device for the inner wall of a vein during lower extremity venous surgery, which reduces the risk of recurrence after treatment of lower extremity varicose veins caused by saphenous vein reflux by closing the deep vein confluence of the saphenous vein to shorten the time of venous occlusion and enhance the therapeutic effect. Background Technology

[0002] The veins of a healthy leg are equipped with valves that operate to ensure that blood supplied from the heart to the lower limbs moves back toward the heart in only one direction.

[0003] These valves open when blood moving along the veins flows toward the heart, and close when attempting to prevent backflow of blood or venous reflux.

[0004] When veins weaken and dilate, the venous valves cannot close properly, leading to impaired drainage caused by reflux and a decrease in venous blood flow from the legs.

[0005] Venous reflux is most common in the superficial veins, and the largest superficial vein is the great saphenous vein, which originates from the deep veins and extends from the upper side of the foot to the groin.

[0006] Depending on the severity, symptoms of venous reflux may be visible to the naked eye or may not be present.

[0007] Symptomatic venous reflux is a stage where the disease has progressed significantly, and symptoms and signs, such as leg pain and swelling, painful venous scrotum, skin changes like spots or inflammation, and open skin ulcers, can have a profound impact on the patient's quality of life, so it is recommended to seek treatment at a specialized medical institution.

[0008] Therefore, the treatment of symptomatic venous reflux involves eliminating the reflux at the source, such as the great saphenous vein; when the diseased vein is occluded or removed, blood is automatically redeployed into other veins without any known adverse consequences for the patient.

[0009] Existing non-invasive methods to treat reflux in the great saphenous vein include sclerotherapy, including radiofrequency (RF) ablation, laser endothermal ablation, and foam sclerotherapy.

[0010] Although foam sclerotherapy is relatively non-invasive among these, it carries a high risk of recurrence and potential sequelae.

[0011] In order to solve these problems, a configuration for treating venous insufficiency in which a vein is compressed at least partially along the treatment site has been proposed in Korean Patent Publication No. 10-2012-0021299 (hereinafter referred to as the prior invention).

[0012] The prior invention is an injector for delivering a vein-occlusive substance into a vein, wherein the injector comprises an adapter having a distal end and a proximal end implemented to be coupled with a syringe implemented to contain the vein-occlusive substance.

[0013] The adapter is implemented to form a central lumen having openings at the proximal end of the adapter and the distal end of the adapter, and the adapter is positioned at the distal end of the injector.

[0014] The injector further comprises an actuating device implemented to move the distal end of the plunger within the central lumen of the plunger and the adapter, and the distal end of the plunger is implemented to press the proximal end of the syringe within the adapter.

[0015] The above injector is operably connected to a control device, and as the control device is activated, the injector delivers a bolus of 0.05 mL to 3 mL of the vein-occlusive substance into the vein.

[0016] The above control device is an injector implemented to control the injector to deliver a plurality of spaced boluses of the vein-occlusive material; a catheter having a proximal end, a distal opening, and a side wall, wherein when the syringe is fitted to the distal end of the adapter, the proximal end of the catheter is implemented to be operablely connected to the injector through the syringe, and the catheter is implemented to advance distally across the treatment site within the vein.

[0017] This initial procedure poses almost no risk of damage to surrounding nerves or tissues and can simply treat veins, such as varicose veins in the lower extremities that exhibit abnormal reflux, based on the venous occlusion system.

[0018] However, since this technique blocks blood flow through the blood vessels and relies on venous occlusion substances to damage the endothelial cells in contact with the venous lumen, causing the vein to be compressed by compression stockings and leave scars over time to become completely sealed, it was accompanied by the problem that it took a long time to achieve a full recovery. Prior art literature

[0019] Republic of Korea Patent Publication No. 10-2012-0021299 (Published July 6, 1998) The problem to be solved

[0020] The present invention aims to reduce the risk of recurrence of varicose veins after treatment caused by saphenous vein reflux in untreated areas during varicose vein treatment.

[0021] The present invention aims to provide high-quality medical services to patients by shortening the time of venous occlusion and increasing the therapeutic effect during lower extremity vein surgery. means of solving the problem

[0022] The present invention provides a catheter comprising: an outer catheter of a predetermined length made of a flexible material that is inserted into a blood vessel; an inner catheter inserted into the interior of the outer catheter and sliding therein; a stimulating body that forms a stimulating layer on the surface of a friction ball formed by twisting several strands of wire tips made of an elastic material into a spiral shape and compressing them to stimulate and damage the inner wall of the vein, an expanding member that extends in the longitudinal direction of the inner catheter emerging from the tip of the outer catheter, and a back body having a hook on the surface of a cylindrical tube connected to the expanding member that controls movement in the direction of the deep vein and a therapeutic agent absorbed by the human body inside. The objective is fully achieved by providing a configuration comprising: an outer catheter made of a flexible material and inserted into a blood vessel and inserted into a blood vessel.

[0023] In a configuration in which the objective of the present invention is achieved, the stimulating body preferably has a stimulating layer formed on the surface of the wire forming the friction hole that damages the inner wall of the blood vessel, and the stimulating layer is preferably formed of a plurality of protrusions.

[0024] In a configuration in which the objective of the present invention is achieved, it is preferable that the expansion member and the back body be configured such that a spiral groove is formed at the tip of the expansion member and a screw rod is formed protrudingly at the rear end of the back body.

[0025] In a configuration in which the objective of the present invention is achieved, the back body is preferably configured such that a cylindrical tube is formed by twisting several strands of Vicryl material, and the therapeutic agent inside the tube is composed of oxidized regenerated cellulose.

[0026] In a configuration in which the objective of the present invention is achieved, the cylindrical tube is preferably configured such that the tube formed by twisting the Vicryl material has elasticity, and the surface of the Vicryl material located inside is coated or impregnated with oxidized regenerated cellulose. Effects of the invention

[0027] The present invention has the advantage of significantly reducing the recurrence of varicose veins after treatment by minimizing the untreated venous area left behind during varicose vein surgery, and significantly improving the treatment of varicose veins by treating the patient under local anesthesia while minimizing pain.

[0028] In addition, the present invention has the advantage of providing the same effect in the treatment of pelvic congestion syndrome caused by ovarian vein reflux and varicocele, in addition to lower extremity vein surgery. Brief explanation of the drawing

[0029] FIG. 1 is an excerpt of a catheter for intravenous surgery to which the present invention is applied. FIG. 2 is an exploded view of a physical stimulator of the inner wall of a vein to which the present invention is applied. FIG. 3 is a diagram of a backbone structure that induces vascular occlusion to which the present invention is applied. FIG. 4 is an excerpt of the back body's vicryl in the present invention. FIG. 5 is an assembly cross-sectional view of a back body and an inner catheter to which the present invention is applied. Specific details for implementing the invention

[0030] Specific embodiments in which the present invention can be implemented are described below with reference to the accompanying drawings.

[0031] These embodiments are described in sufficient detail to enable a person skilled in the art to practice the invention, and it should be understood that various embodiments of the invention are different but need not be mutually exclusive.

[0032] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the attached drawings in order to enable a person skilled in the art to easily practice the present invention.

[0034] Figure 1 shows the extraction state of a catheter for intravenous surgery to which the present invention is applied.

[0035] In order to perform vascular surgery, a catheter (100) with a diameter and a predetermined length that can be inserted into a blood vessel is required.

[0036] In particular, the catheter (100) for performing venous surgery is equipped with an external catheter (110) made of a flexible material that is suitable for insertion into a blood vessel and has a predetermined length to sufficiently reach the surgical site, and which bends along the shape of the blood vessel when inserted along the blood vessel.

[0037] An inner catheter (120) is provided that is inserted into the interior of the outer catheter (110) and slides along its inner diameter to approach a distal area, thereby allowing a small amount of venous occlusion material containing any substance to be injected into the vein.

[0038] On one side of such a catheter (100), a Luer lock is formed to which a glue gun is connected to selectively perform the action of injecting a small amount of vein occlusion material containing any substance into the vein.

[0040] Figure 2 shows the decomposed state of the physical stimulator of the inner wall of the vein to which the present invention is applied.

[0041] Several strands of the tip of the elastic material wire (210) inserted into the inner catheter (120) are twisted spirally and bundled together to form a stimulating body (200) that forms a friction hole (220).

[0042] And, a stimulating layer (221) is formed on the surface of the clustered friction ball (220) to stimulate and damage the inner wall of the vein, and a plurality of barbs (223) are formed on the surface of the spirally twisted wire (210) forming the stimulating layer (221).

[0043] The friction ball (220) formed by the spirally twisted wire (210) retains elasticity.

[0044] At this time, the elasticity causes a close contact with the distal part while inserted into the blood vessel, and when the friction ball (220) moves while in close contact, the barb (223) causes a large frictional resistance, causing a scratch on the inner wall of the blood vessel.

[0046] FIG. 3 shows the structural state of a backbone body that induces vascular occlusion of the inner wall of a vein to which the present invention is applied, and FIG. 4 shows the extraction state of the vicryl of the backbone body in the present invention.

[0047] The above back body (400) is formed by twisting several strands of Vicryl material, which is absorbed and disappears after about 60 days in the human body, to form a tube (410) while healing and closing the wound on the inner wall of the blood vessel created by the friction ball (220).

[0048] The tube (410) formed by multiple strands is cylindrical, so it possesses elasticity that allows it to contract and return due to the vicryl material.

[0049] The surface of the vicryl material forming the above back body (400) is impregnated or coated with a therapeutic agent (420) that is absorbed into the human body after 30 days.

[0050] In selecting the above therapeutic agent (420), oxidized regenerated cellulose is suitable.

[0051] Additionally, a screw rod (415) is formed on one side of the tube (410) to receive operating force from the operator, and a hook (412) is formed on the surface of the Vicryl material of the back body (400) to prevent it from moving in the direction of the deep vein during vascular surgery.

[0053] Figure 5 shows the assembled cross-sectional state of the back body and the inner catheter to which the present invention is applied.

[0054] The back body (400), formed from multiple strands of vicryl containing a therapeutic agent (420), is configured to be connected to the tip of an inner catheter (120) inserted into the outer catheter (110) while the outer catheter (110) is inserted into the blood vessel to access a distal member during the treatment process.

[0055] In order to insert the above back body (400) into the interior of the inner catheter (120), an expansion hole (300) is applied, so the expansion hole (300) is formed with a diameter equal to the diameter of the inner catheter (120) and a predetermined length so that a spiral groove (310) is formed at the tip to connect the back body (400).

[0056] Accordingly, the back body (400) containing the therapeutic agent (420) is structured to be connected to the inner catheter (120), so it slides within the inner diameter of the outer catheter (110) according to the operation of the inner catheter (120) and reaches the treatment location.

[0057] When the selected treatment location is reached, the hook (412) protruding from the surface of the vicryl material gets caught on the inner wall of the blood vessel, so that it cannot move toward the deep vein.

[0058] When the backbone (400) reaches a vascular treatment position where it cannot move in the direction of heart failure, the expansion hole (300) and the backbone (400) are separated by the operator's manipulation, and then the outer catheter (110) and the inner catheter (110) are removed from the blood vessel.

[0059] The present invention is used to close the deep vein confluence of the saphenous vein to reduce the risk of recurrence after treatment of the lower extremity veins during vascular surgery.

[0060] First, with the inner catheter (120) inserted into the outer catheter (110) of the catheter (100), the treatment is started by inserting it into the lower extremity vein, leaving 2 cm at the confluence of the deep vein of the saphenous vein.

[0061] Leaving 2 cm at the confluence of the deep veins provides the effect of minimizing the remaining area compared to the conventional method where 5 cm had to be left at the confluence due to the risk of deep vein thrombosis.

[0062] That is, the catheter (110) is positioned 1 cm below the point of confluence with the heart and the expansion hole (300) is removed.

[0063] Afterwards, a back body (400) containing a therapeutic agent is inserted into the inner catheter (120) to reach the tip of the outer catheter (110).

[0064] Afterwards, the outer catheter (110) is withdrawn about 10 cm so that the tip of the inner catheter (120) is exposed at the location where the tip of the outer catheter (110) was.

[0065] With the expansion hole (300) held, the inner catheter (120) is pulled so that it is pulled out about 3 cm.

[0066] The back body (400) is exposed by the pulling motion of the inner catheter (120).

[0067] The operator uses an ultrasound detector to check if the tube (410) of the back body (400) is in the correct position, and if it is in the correct position, completely removes the inner catheter (120) from the blood vessel.

[0068] In the above process, it is obvious that the outer catheter (110) must also be completely removed from the blood vessel.

[0069] Through the above procedure, the oxidized regenerated cellulose component impregnated or applied to the vicryl material of the back body (400) is absorbed into the human body and closes the remaining gap of the confluence area, which is at risk of deep vein thrombosis, to the maximum extent possible.

[0071] Although embodiments have been described as above, the present invention is not limited to the above embodiments and can be manufactured in various different forms, and a person skilled in the art to which the present invention belongs will understand that it can be implemented in other specific forms without changing the technical concept or essential features of the present invention.

[0072] Therefore, the embodiments described above should be understood as exemplary in all respects and not limiting. Explanation of the symbols

[0073] 100: Catheter 110: Lateral catheter 120: Internal catheter 200: Stimulator 210: Wire 220: Friction point 221 : Stimulating layer 223 : Spines 300 : Dilating zone 310 : Spiral groove 400 : Back body 410 : Tube 412 : Hook 415 : Screw rod 420 : Treatment

Claims

Claim 1 A catheter comprising an outer catheter of a predetermined length made of a flexible material inserted into a blood vessel, and an inner catheter inserted into the interior of the outer catheter and sliding therein; a stimulating body forming a stimulating layer on the surface of a friction member formed by twisting multiple strands of elastic wire tips into a spiral shape and inserting them into the inner catheter to stimulate and damage the inner wall of the vein; an expansion member extending in the longitudinal direction of the inner catheter emerging from the tip of the outer catheter; and a back body having a hook on the surface of a cylindrical tube connected to the expansion member that controls movement in the direction of the deep vein, and having a therapeutic agent absorbed by the human body inside. A mechanical and chemical resection device for the inner wall of a vein during lower extremity venous surgery, comprising: a stimulating body having a stimulating layer formed on the surface of a wire forming the friction hole that damages the inner wall of a blood vessel, wherein the stimulating layer is formed with a plurality of barbs; wherein the expansion hole and the back body have a spiral groove formed at the tip of the expansion hole and a screw rod protruding at the rear end of the back body, wherein the back body is formed by twisting a cylindrical tube of multiple strands of Vicryl material, and the therapeutic agent inside the cylindrical tube is oxidized regenerated cellulose. Claim 2 delete Claim 3 delete Claim 4 delete Claim 5 A mechanical and chemical resection device for the inner wall of a vein during lower limb venous surgery according to claim 1, wherein the cylindrical tube formed by twisting the vicryl material is provided with elasticity, and oxidized regenerated cellulose is coated or impregnated on the surface of the vicryl material located inside.

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