KR102080330B1 - Varicose vein surgery kit and surgical method using the same - Google Patents

Abstract

The present invention provides a surgery kit for a varicose vein to treat the varicose vein in a complex method in which a vascular tissue is exposed to drug to be chemically blocked while a physical damage is applied thereto by expansion of a balloon; and a surgery method using the same. According to the present invention, the surgery kit for a varicose vein comprises: a catheter (10) including a first lumen (12) moving an expansion liquid therein and a second lumen (14) moving drug therein; a balloon (20) installed at an end part of the catheter to be connected to the first lumen (12), and expanded by an expansion liquid injection pressure to damage a blood vessel; an inflator part (30) connected to the first lumen (12) to control supply of the expansion liquid; and a syringe part (40) connected to the second lumen (14) to control drug supply into the blood vessel damaged by the balloon (20). Accordingly, surgery time is remarkably reduced and a surgery method is simplified, thereby providing advantages of decreasing fatigue of an operator, reducing economic burden, and shortening a life return time due to mitigation in a problem such as a side effect in accordance with surgery.

Description

Varicose vein surgery kit and surgical method using the same {Varicose vein surgery kit and surgical method using the same}

The present invention is a lower extremity varicose vein surgical kit and a surgical method using the same, which will be described in more detail the lower extremity varicose veins to treat varicose veins varicose veins tissues are exposed to drugs in the state of physical damage caused by balloon expansion It relates to a surgical kit and a surgical method using the same.

Normal varicose veins are exposed to the outer surface of the vein (outer vein) in the leg, as the disease progresses, as the progression of valve failure progresses, chronic venous insufficiency occurs, repeated vicious cycle, chronic venous insufficiency chronic chronic lower extremity Complications such as swelling, fibrosis of the lower extremity skin, and venous ulcers of the lower extremity are accompanied, so rapid treatment is required.

Such varicose vein treatment methods include the use of medical compression stockings, vascular sclerotherapy that invades blood vessels by injecting angiotensifiers, radiofrequency ablation that inserts high frequency devices into the vessels and injures the vessels by applying heat to the vessels, into the vessels. There is a laser treatment that uses a laser device to damage blood vessels with a laser beam, and a vein extraction that directly removes a vein through surgery.

However, the treatment method of wearing compression stockings has the disadvantage that the fundamental treatment is difficult and takes a long time to recover. Vascular sclerotherapy is a radical treatment and is used only as an auxiliary treatment method. Side effects, such as nerve damage, and other problems remain, laser therapy also has the problem that the wound remains and side effects, intravenous extraction requires a general anesthesia, a large wound remains and a high degree of fatigue for surgery was followed.

Accordingly, the "vein closure method and apparatus for treating venous insufficiency" disclosed in Korean Patent No. 10-1781653, which is disclosed in the related art, is an injector for delivering a vein-closing material into a vein, wherein the injector is the vein-closing material. An adapter having a distal end and a proximal end configured to mate with a syringe implemented to include a adapter, the adapter forming a central lumen having openings at the proximal end of the adapter and the distal end of the adapter, the adapter having And an actuator configured to move the distal end of the plunger within the central lumen of the adapter, the distal end of the plunger being in the distal end of the injector; And to inject the proximal end of the syringe, the injector being operable to a control device. Operatively connected, and as the control device is activated, the injector delivers 0.05 mL to 3 mL of the bolus of the vein-closing material into the vein, and the control device controls the injector to control the vein- An injector implemented to deliver a plurality of spaced boluses of the closure material; A catheter having a proximal end, a distal opening, and a side wall, wherein the proximal end of the catheter is operatively connected to the injector through the syringe when the syringe is mated to the distal end of the adapter, the catheter being the A system for treating veins has been pre-registered, including a catheter, which is implemented to advance in distal direction across the treatment site in the vein.

However, it blocks blood flow through the blood vessels and relies on venous-closure material to damage endothelial cells in contact with the venous lumen, and then the veins are pressed into compression stockings, leaving scars over time. Since it is a completely sealed technology, it takes a long time to cure.

In addition, another prior art “glue-based varicose vein treatment” of patent registration No. 10-1995043 is a handle defining a receptacle into which a cartridge is inserted, wherein the cartridge has three advances into the vein from an access site. Elongated endotracheal member; And a wire contained within said elongate duct member having a disturbing member; A handle; Means for imparting motion to the wire; And a source of venous occlusion material in fluid communication with the vascular member, wherein the disturbing member is a tip of a wire, the wire generating a backflow of blood in the blood vessel as the tip rotates. Techniques including blade configurations have been previously registered.

However, the prior art is a technique configured to damage the inner vessel wall by contacting the inner vessel wall when the traumatic tip of the wire is rotated, but the vessel lining damaged by the trauma tip is wound around the trauma tip To prevent the injection of the vein occlusion or to prevent the smooth injection of the vein, it takes a lot of time for more than 8 seconds to 1cm blood vessel treatment, especially the disposable kit price is more than 1 million won The burden of the procedure cost was a big problem.

KR 10-1781653 B1 (2017.09.19.) KR 10-1995043 B1 (2019.06.25)

In the present invention, to solve the above-mentioned problems of the prior art, a new technology was developed, and the inside of the blood vessel corresponding to the balloon length at a time by inflating a long balloon to the vascular tissue to be treated for varicose veins The problem to be solved by the present invention is to provide a surgical kit using the same varicose vein surgical kit that can be physically damaged.

Another problem of the present invention is to provide a varicose vein surgical kit that can be economical procedure by adopting the equipment suitable for the blood vessel diameter of the patient through the ultrasound treatment before the procedure.

Along with this, although not separately described, other objects within the range that can be inferred in consideration of the specific details and claims for carrying out the invention are included in the overall problem of the present invention.

In the present invention as a specific means for solving the above problems of the present invention constituting the lower limb varicose vein surgical kit, the catheter is composed of the first lumen 12 and the second lumen 14, the drug is moved 10; A balloon 20 installed at an end of the catheter 10 and connected to the first lumen 12 and expanded by an expansion fluid injection pressure to damage a blood vessel; An inflator unit 30 connected to the first lumen 12 to control an expansion liquid supply; And a syringe unit 40 connected to the second lumen 14 and configured to control drug supply into a blood vessel damaged by the balloon 20.

At this time, the second lumen 14 of the catheter 10 is penetrated through the balloon 20, characterized in that the nozzle (14a) is provided so that the drug is injected into the back of the balloon (20).

In addition, the second lumen 14 is characterized in that it is used as a guide tube to be moved on the guide wire 50 when inserting the balloon 20 into the blood vessel.

In addition, the inflator 30 is provided with a screw-type syringe so as to make the supply of the expansion liquid constant, thereby supplying pressure to inflate the balloon 20 at an equal pressure, and the outer diameter of the balloon 20. It is characterized in that it is configured to expand to 10 ~ 30% expanded size compared to the vessel diameter.

As a specific means for solving the above problems of the present invention, the present invention proposes a surgical method using a varicose vein surgery kit, which includes inserting a guide wire 50 into a blood vessel to be treated for varicose veins (S1); Inserting the balloon 20 together with the catheter 10 into the blood vessel guided by the guide wire 50 (S2); Removing the guide wire (50) and injecting the expansion liquid into the first lumen (12) of the catheter (10) to physically damage the vascular tissue by balloon (20) expansion (S3); And the balloon 20 is moved after contraction and chemically occludes the sector T1 in which the vascular tissue is damaged by injecting a drug into the second lumen (S4).

In this case, the balloon 20 is prepared for each expansion standard size standard, and based on the blood vessel information obtained through a pre-test step to extract the blood vessel size information, select the balloon 20 of the same size or larger than the vessel size It is characterized in that it is provided to.

According to the specific means for solving the above-described problems, the present invention is to expand the vascular tissue to be treated for varicose veins varieties by balloon expansion, thus uniformizing the inside of the blood vessel corresponding to the balloon length through one balloon expansion Since it may be physically damaged, problems such as side effects due to the procedure are improved and the procedure time is remarkably shortened, and thus the operator time is reduced and the patient's daily return time is shortened.

In addition, the lower extremity varicose vein surgical kit of the present invention is less than the equipment used in the conventional surgical method, and because the use of cheaply distributed components that can significantly reduce the patient's economic cost, the expected effect is great. .

1 and 2 is a configuration diagram showing a part of the lower extremity varicose vein surgical kit provided in the present invention.
Figure 3 is a block diagram showing the operation and operation method of the lower extremity varicose vein surgical kit provided by the present invention.
Figure 4 is a flow chart schematically showing a surgical method using a lower extremity varicose vein surgical kit according to an embodiment of the present invention.

Hereinafter, with reference to the accompanying drawings will be described specific details for the practice of the invention. In the following description of the present invention, when it is determined that the subject matter of the present invention may be unnecessarily obscured by those skilled in the art with respect to known functions, detailed description thereof will be omitted.

The present invention relates to a lower extremity varicose vein surgical kit and a surgical method using the same, which is a complex method in which the vascular tissue to be treated for the lower extremity varices is chemically occluded by being exposed to the drug in a physically damaged state as the balloon is expanded by sectors Catheter 10, the balloon 20, the inflator portion 30, the syringe portion 40 and the guide wire 50 consists of a main leg to treat the varicose veins.

1 is a view showing the first embodiment of the catheter 10, which is a medical instrument that is inserted into the human body of the surgical kit for lower extremity varicose veins provided by the present invention in detail, the catheter 10 of the present invention is the first It consists of one lumen 12 and a second lumen 14 through which the drug is moved.

The catheter 10 is formed as a two-room tube in which the first and second lumens 12 and 14 are integrally formed and inserted into the blood vessel. FIG. 1 shows a catheter in which the catheter 10 is formed as a two-room tube, and the first and second lumens 12 and 14 ports are formed at one end thereof, and FIG. 2 shows another embodiment of the catheter 10. The catheter 10 is formed as a two-room tube from a section of the catheter 10, and a first lumen 12 port through which the expansion liquid is moved is formed at one end of the catheter 10, and the second lumen 14 port starts the two-lum tube. The state formed in the inner center of the catheter 10 is shown.

In this case, the first lumen 12 is a tube used in combination with an inflater to move the expansion liquid for expanding the balloon 20, which will be described later, and the second lumen 14 may move the drug. It is used as a guide tube guided by the guide wire 50 when inserting the catheter 10 and the catheter 10 commonly used in combination with a syringe (syringe).

Here, the second lumen 14 of the catheter 10 passes through the balloon 20, and a nozzle 14a is provided to inject drugs into the back surface of the balloon 20. In addition, when the second lumen 14 is inserted into the blood vessel 20, the second lumen 14 is moved on the guide wire 50 previously inserted into the blood vessel by a blood vessel catheter, and the balloon 20 is intended to perform varicose veins. The guide wire 50 is removed after insertion to the vessel position.

Although not shown in the figure, the catheter 10 is marked with a scale at regular intervals so as to check the scale during the procedure to move backward to the exact length by the length of the balloon (20).

Figure 3 is a block diagram showing the operation state and surgical method of the lower extremity varicose vein surgical kit.

When a drug (eg, a curing agent) is injected through the second lumen 14, the drug is injected into the back surface of the balloon 20 through the nozzle 14a and the blood vessel sector physically damaged by the balloon 20 expansion force ( The drug is applied to T1), and at this time, since the injection of the drug is performed in a state in which the vascular sector T2 is closed by the balloon 20 expansion force as shown in FIG. 3 (d), the drug is lost to the vascular sector T2. This prevents the drug from being applied quantitatively in the correct position, thereby providing an excellent surgical effect.

Next, the balloon 20 according to the present invention will be described with reference to the drawings. The balloon 20 is expanded by the expansion fluid injection pressure and is installed at the end of the catheter 10 so as to be connected to the first lumen 12. . The balloon 20 is formed to have a diameter smaller than the diameter of the vessel to be operated upon contraction, and to expand to a size larger than the diameter of the vessel when the balloon is inflated.

That is, the balloon 20 is inserted into the blood vessel, the outer diameter is provided to expand to a size 10 to 30% expanded compared to the inner diameter of the blood vessel, for example, when the inner diameter of the blood vessel is 6mm, the balloon 20 is non- In the expanded state is maintained less than 6mm is inserted into the blood vessel, and after insertion into the blood vessels in the process of expanding the size of 10-30% expanded size based on the internal diameter of the 6mm of the blood vessel damages the lining and the media tissue of the vessel.

In this case, when the balloon 20 is expanded to less than 10% of the vascular inner diameter, the inner and middle tissues of the blood vessels have insufficient damage rate, and if the balloon 20 is expanded to more than 30% of the vascular inner diameter, the vascular outer membrane may burst. The outer diameter of (20) is preferably used to be expanded to 10-30% expanded size compared to the inner diameter of the blood vessel.

Figure 5 shows another embodiment of the balloon 20, the uneven portion 21 is formed on the outer circumferential surface of the balloon 20, it is provided to grip and damage the vascular lining during expansion. The tip is protruded sharply in a linear or pointed shape of the concave-convex portion 21, and when the balloon 20 is inflated, the convex-concave portion 21 is expanded to a size larger than the inner diameter of the blood vessel in a state where the convex-concave portion 21 is gripped by the vascular lining.

Accordingly, the vascular inner membrane as well as the medial tissue are easily damaged by the gripping force of the uneven portion 21, and the drug penetration force is improved through the damaged portion by the uneven portion 21. In particular, the vascular circumferential surface of the balloon 20 is expanded. Since the frictional force is increased and firmly fixed, the procedure precision for each sector (eg, the vessel length corresponding to the balloon length) can be improved.

The inflator unit 30 according to the present invention has a port formed to be detachably coupled to one end of the first lumen 12, and is connected to the first lumen 12 to control the expansion liquid supply into the balloon 20. It is provided.

In this case, a screw-type syringe is installed in the inflator unit 30 so that the supply of the expansion liquid is constant, and the expansion liquid (physiological saline) is injected in consideration of the expansion rate of the balloon 20 relative to the amount of expansion liquid injection, and the balloon is injected. After the physical blood vessel damage process is completed by (20), the expansion liquid is recovered to the inflator unit 30 is provided so that the balloon 20 shrinks.

The inflator section 30 of the present invention does not need to install a separate barometer. When only a cc of expansion liquid is supplied into the balloon 20, information about how large the outer diameter of the balloon is expanded is provided in the form of a table, and the pressure is constantly applied using a syringe installed in the inflator unit 30. By supplying it, the balloon 20 can be expanded with an equal pressure.

The syringe portion 40 according to the present invention is connected to the second lumen 14 and is provided to control the drug supply into the blood vessel damaged by the balloon 20. The syringe unit 40 is provided in the form of a manual syringe or an automatic pump, and the supply amount of the drug is controlled in consideration of the length of the physical vessel damaged sector T1 by the balloon 20. As an example, it is preferred to inject 0.2-0.3 cc of drug against a 6 mm vascular standard, 1 cm of physically damaged sector length.

In this way, the lower extremity varicose veins are treated in a complex manner in which the vascular tissue to be treated for varicose veins expands sectorally by the expansion of the balloon 20 and is exposed to the drug in a state of physical damage, thereby chemically occluding the lower limb varices, In addition to the significantly shortened time, the procedure is simplified to reduce the fatigue of the operator and reduce the burden of the patient's economic cost, and the problems such as side effects from the procedure are improved, thereby reducing the daily return time.

Figure 4 is a flow chart schematically showing a surgical method using a lower extremity varicose vein surgical kit according to an embodiment of the present invention.

Surgical method using the lower extremity varicose vein surgical kit according to the present invention, the step of inserting the guide wire 50 (S1), the step of inserting the balloon 20 with the catheter 10 (S2), physically vascular tissue Comprising the step (S3), the vascular tissue consists of a major step comprising a step (S4) to chemically block the sector (T1) damaged. The varicose vein surgical kit used at this time is the same as the configuration of Figs.

1. Inserting the guide wire 50 (S1)

Inserting the guide wire 50 according to the present invention (S1) is a step of inserting the guide wire 50 into the blood vessel to be treated for varicose veins.

After inserting an access needle into the vein to be operated by ultrasound and then inserting a microwire through it, the access needle is removed and a vascular catheter is inserted along the microwire.

Guide wire 50 is inserted through the blood vessel catheter to the depth of the blood vessel to be treated for varicose veins, guided to the wire 50 to the balloon 20 formed on the front side of the catheter 10 to be described later When the balloon 20 is inserted into the blood vessel to be treated, the guide wire 50 is removed.

2. Inserting the balloon 20 with the catheter 10 (S2)

Inserting the balloon 20 with the catheter 10 according to the present invention (S2) is guided to the guide wire 50 inserted into the vein in the process to insert the balloon 20 with the catheter 10 It's a step. The balloon 20 is formed at the front end of the catheter 10, the position movement of the balloon 20 is controlled according to the insertion length of the catheter 10. At this time, the outer diameter of the balloon 20 has a size smaller than the inner diameter of the blood vessel as shown in FIGS. 3 (a) and 3 (c).

At this time, the balloon 20 is prepared by standardizing the length and the maximum expansion diameter. That is, based on the blood vessel information (inner diameter size) obtained through the pre-test step (eg, ultrasound) to extract the blood vessel size information of the patient, it is provided to select and apply the balloon 20 having the most suitable dilation standard .

As an example, when the inner diameter size of the vein is 6 mm by the pre-inspection step, the effective expansion size of the balloon 20 is larger than 6 mm, and the standard that is smaller than 5 mm at the time of contraction is selected.

Of course, the effective inflation size of the balloon 20 may be operated by selecting the same size as the size of the vessel diameter. In general, the balloon is designed in consideration of the safety factor, so when inflated, the balloon expands beyond the size of the vein diameter so that the balloon can be swollen enough to damage the vein tissue.

3. Physically damaging the vascular tissue (S3)

Physically damaging the vascular tissue according to the present invention (S3), by removing the guide wire 50, inflation fluid into the first lumen 12 of the catheter 10 to expand the balloon 20 Thereby physically damaging the vascular tissue.

In step S3, the balloon 20 is expanded for 4 to 7 seconds as shown in FIG. 3 (b), and then contracted after damaging the inner and middle layers of the vascular tissue, and then the balloon 20 is as shown in FIG. 3 (c). After the catheter 10 is moved by a distance corresponding to the balloon 20 length value by the pulling force, steps S3 to S4 are repeatedly performed.

4. chemically occluding the damaged sector of the vascular tissue (S4)

Chemically blocking the sector T1 damaged blood vessel tissue (S4) according to the present invention, the balloon 20 is moved after contraction, the drug is injected into the second lumen sector (T1) damaged blood vessel tissue Is chemically occluded.

In this case, the drug injection may be performed in a state in which the balloon 20 is inflated to an outer diameter larger than the inner diameter of the vein in a state in which the balloon 20 is located in the sector T2, as shown in FIG. In this case, physical damage to the vein of the sector (T2) and at the same time the drug is injected into the sector (T1) at the same time has the effect of shortening the operation time, and also the inside of the blood vessel by the expanded balloon 20 one side ( Since it is closed in the sector T2), the loss of the drug injected into the damaged sector T1 of the vascular tissue is prevented, and the drug is applied to the blood vessel of the damaged sector T1, thereby ensuring an effective and excellent surgical effect.

For example, if the length of the vein to be operated is 12cm, the length of the balloon 20 is 4cm, if the balloon 20 is maintained in the expanded state for 4 to 7 seconds through the step S3, the length of the balloon 20 Physical damage is applied to the sector T1 of 4 cm corresponding to, and then the catheter 10 is pulled by 4 cm to move the position of the balloon 20, and then the drug is injected into the second lumen to damage the vascular tissue. The procedure is completed by repeating the process of chemically occluding the sector T1 three times.

After the procedure is completed through the above-described steps to wear a compression stockings in the surgical site to maintain the blood vessel is in a pressurized state.

As described above in the detailed description of the present invention has been described with respect to the most preferred embodiment of the present invention, various modifications will be possible within the scope without departing from the technical scope of the present invention. Therefore, the scope of protection of the present invention should not be limited to the above embodiments, but the scope of protection from the technologies described in the claims and the equivalent technical means will be recognized.

10: catheter 12: first lumen
14 second lumen 14a nozzle
20: balloon 21: request
30: Inflator 40: syringe section
50: guide wire

Claims (8)

A catheter 10 composed of a first lumen 12 through which the expansion fluid is moved and a second lumen 14 through which the drug is moved;
A balloon (20) installed at the end of the catheter (10) and connected to the first lumen (12) and expanded by the expansion liquid injection pressure to damage the blood vessel;
An inflator unit 30 connected to the first lumen 12 to control an expansion liquid supply;
And a syringe unit 40 connected to the second lumen 14 to control drug supply into a blood vessel damaged by the balloon 20.
The second lumen 14 of the catheter 10 penetrates the balloon 20, and a nozzle 14a is provided to inject drugs into the back surface of the balloon 20.
The second lumen 14 is used as a guide tube to be moved on the guide wire 50 when the balloon 20 is inserted into the blood vessel,
The inflator 30 is provided with a screw-type syringe so as to make the supply of the expansion liquid constant, and inflates the balloon 20 at a uniform pressure by supplying a constant pressure,
The outer diameter of the balloon 20 is expanded to a size that is 10 to 30% larger than the inner diameter of the blood vessel, thereby damaging the inner and medial tissues of the blood vessel, and moved by a distance corresponding to the length of the balloon 20, and the syringe portion 40 ) Is supplied to the back of the balloon (20) through the nozzle (14a) and varicose vein surgical kit, characterized in that it is configured to chemically block the vascular sector (T1) physically damaged.
delete delete delete The method of claim 1,
The lower peripheral vein surgery kit, characterized in that the uneven portion 21 is formed on the outer circumferential surface of the balloon 20, so as to grip and damage the vascular lining when inflated.
delete delete delete

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