KR102536453B1 - Endovascular Apparatus and Device with Labyrinthine Septum Capable of Endovascular Blood Flow Reopening and Microfluidic Circuit Generation - Google Patents

Abstract

The present invention relates to an endovascular apparatus with a labyrinthine septum capable of reopening endovascular blood flow and generating a microfluidic circuit, in which due to reopening of blood flow within the blood vessel and generation of a microfluidic circuit through a plurality of side holes, blood clots can be continuously sucked and the blood clots are broken into small pieces or broken to be removed cleanly, the blood clots can be removed while minimizing vascular damage and the occurrence of distal emboli from the crushed blood clots, and the microfluidic circuit is generated, such that the blood clot is moved along the created fluid circuit while being continuously deformed and broken into small pieces, thereby recovering the blood clot through a guide conduit. Accordingly, blood clots, such as cerebral blood vessels, within the blood vessels with small diameters and tortuous paths can be effectively crushed and removed, and since a fluid jet acts directly on the blood vessel wall rather than a material with high hardness such as metal, damage to the blood vessel can be minimized. The endovascular apparatus comprises a blood clot removal device, a drug delivery device, and a local blood vessel wall fluid collection device.

Description

Endovascular Apparatus and Device with Labyrinthine Septum Capable of Endovascular Blood Flow Reopening and Microfluidic Circuit Generation}

The present invention relates to a vascular device having a labyrinth septum capable of reopening blood flow within a blood vessel and creating a microflow circuit, and has functions such as removing blood clots, collecting body fluid from a local blood vessel wall, and delivering drugs. Thrombus removal that can remove blood clots while minimizing blood vessel damage and distal embolism of pulverized thrombi. When it is necessary to precisely deliver drugs or cells locally by targeting the device and the lesion on the blood vessel wall, a high-concentration drug or cell is delivered to the blood vessel wall through the microfluidic circuit without interruption of blood flow while securing an intravascular bypass. A blood vessel wall local drug delivery device that can perform local drug delivery procedures on the blood vessel wall by allowing the fluid to stay for a long time, and atherosclerotic plaques and blood vessels It is possible to analyze the concentration of intercellular signaling substances such as exosomes, microRNA, cytokine, and peptides from samples collected from the inside of blood vessels adjacent to vascular lesions such as dissection and cerebral aneurysm. It is an intravascular device for the collection of body fluid from the local blood vessel wall with the ability to determine the volume and volume. In this case, among the components of the microfluidic circuit, the fluid injection passage and the outer hole are composed of a plurality of units and can be separately used for physiological saline injection and sample collection.

Stroke is the third most common cause of death worldwide, killing 140,000 Americans each year from stroke.

87% of strokes are ischemic strokes in which blood flow to the brain area is blocked, and if blood clots are not removed within the golden time, cerebral blood flow is disrupted, resulting in stroke progression and irreversible brain damage.

A stent retriever or a suction conduit is a thrombosis removal device developed and implemented to reopen blood vessels by safely and effectively removing a thrombus, and thrombectomy using a stent retriever or a suction conduit is recognized as a safe and effective thrombus removal treatment.

The safety and effectiveness of thrombectomy using a stent retriever or a suction catheter have been proven, including a high recanalization success rate reaching 70-80% through multicenter clinical trials. became standard treatment. According to standard practice guidelines, acute stroke patients within 24 hours of symptom onset and awakened stroke patients whose symptom onset time is unknown are indications for intra-arterial thrombectomy.

However, existing intra-arterial thrombectomy using a stent retriever or thrombosuction catheter has problems such as 1) vascular damage, 2) risk of contralateral embolism, and 3) the need to repeat the thrombectomy device installation several times.

1) Problems with blood vessel damage

Thrombectomy using a general stent retriever may cause blood vessel damage because mechanical pressure is applied to the blood vessel by the stent structure, and may cause headache and blood vessel spasm. It can even cause complications of subarachnoid hemorrhage due to blood vessel rupture or brain vessel wall damage.

Even the use of a general suction catheter can cause rare but fatal complications such as damage or perforation of cerebral blood vessels.

In animal experiments, endothelial cell damage and proliferation were observed after thrombectomy using a stent retriever, and magnetic resonance imaging of the vessel wall after thrombectomy showed thickening and contrast enhancement of the vessel wall.

In order to reduce these complications, an intravascular thrombectomy device that minimizes contact with the blood vessel wall is desirable.

2) Problems with distal embolism

During a general thrombectomy procedure, a thrombus can embolize into a new blood vessel area different from the site where the existing thrombus is located, and there is a risk of causing potential side effects of distal embolism with a frequency of 1 to 8.6% during the procedure.

The rupture of the thrombus due to the weakening of the internal binding force of the thrombus can cause cerebral infarction in the new blood vessel area, that is, iatrogenic embolism, and efforts should be made to prevent and minimize it. Existing thrombus removal devices may cause embolism by inducing changes such as deformation, elongation, and fracture of the thrombus structure by applying tensile force to the thrombus.

While a general stent retriever drags the clot down, the clot caught in the stent retriever may be elongated and fragmented due to tensile force. Alternatively, the thrombus may be separated from the thrombus removal device, and the thrombi or fragments may be moved or dispersed through the bloodstream to a distal blood vessel. Broken blood clot fragments (emboli) travel through the bloodstream to small branches of peripheral blood vessels and block other blood vessels, impairing the blood supply to tissues.

In contrast, in intravascular thrombectomy procedures such as arteriovenous fistula blockage and venous thrombosis for dialysis, the procedure steps of fragmentation and marceration of thrombi are routinely performed before suction thrombectomy. Clots are routinely fragmented or abraded prior to aspiration, such as balloon inflation and rotation of a pigtail catheter under 0.035 inch j-tip wire guidance within the clot before aspiration. This has the effect of facilitating advancement of the conduit and enhancing thrombus suction power. Place the suction catheter in place, maintain negative pressure for 30 seconds, and remove the clot while withdrawing the catheter while maintaining negative pressure. On the other hand, cerebral vascular thrombectomy does not encourage intentional fragmentation of the clot due to the risk of distal embolism.

3) Necessity of repeated installation of thrombosis removal device due to failure of thrombus recovery or vascular recanalization

It is said that the success rate of clot removal has been greatly improved with the development of general clot removal devices, but clot removal devices may still fail to remove clots. Since not all thrombi are cleanly collected in one thrombus removal attempt, it is necessary to proceed with the thrombus removal device several times into the blood vessel.

In addition, general suction catheters are useful tools for removing blood clots, but the suction success rate of the suction catheters depends on the tube diameter. However, no matter how large the diameter of the catheter is, suction interruption may occur due to closure of the suction catheter lumen during the suctioning process through the suction catheter. There is a need. Therefore, multiple passes through the thrombophlebate are required to recanalize the occluded main blood vessel, which increases the procedure time and increases the risk of ischemic brain damage.

In many cases, the success of the procedure depends on the proficiency of the operator who can place a large-diameter suction tube in the target blood vessel, and therefore it is difficult to standardize the procedure protocol.

In addition, it is technically very difficult to precisely deliver a drug locally to the blood vessel wall through an existing catheter, as the drug is continuously washed away by the pulsatile blood flow, and blood flow bypass may be helpful. It is necessary to select an effective drug and determine the dose by analyzing the pathological condition according to the microenvironment of the blood vessel wall, but it is difficult to collect and analyze a small amount of signaling substances in the pulsatile blood flow state. Hard to apply. Therefore, there is a need for an intravascular device that collects and analyzes local signaling substances on the blood vessel wall in a state of bypassing blood flow and precisely delivers the drug at the same time.

Republic of Korea Patent Registration No. 10-2371076

The present invention has been made to solve the above conventional problems,

It has functions such as removing blood clots, collecting body fluid from local blood vessel walls, and delivering drugs. More specifically, (1) reopening of blood flow in blood vessels and creating a microfluidic circuit through multiple side holes enables continuous suction of blood clots and reduces blood clots. It is a thrombus removal device that can cleanly remove blood vessels by splitting or crushing them, and can remove blood clots while minimizing damage to blood vessels and generation of distal embolism of pulverized thrombi. (2) When it is necessary to precisely deliver drugs or cells locally by targeting lesions on the blood vessel walls, high-concentration drugs or cells are delivered to the blood vessel walls through microfluidic circuits without interruption of blood flow while securing an intravascular bypass It is a blood vessel wall local drug delivery device that can perform a local drug delivery procedure on the blood vessel wall by allowing the fluid to stay for a long time. (3) Concentrations of intercellular signaling substances such as exosomes, microRNA, cytokine, and peptides from samples collected from within blood vessels adjacent to vascular lesions such as atherosclerotic plaques, vascular dissections, and cerebral aneurysms for precise local drug delivery before and after effect evaluation It is an intravascular device for collecting body fluid from the local blood vessel area, which enables analysis, and thus allows for intercellular signaling system research or determination of the type and dose of drugs to be administered. In this case, among the components of the microfluidic circuit, the fluid injection passage and the outer hole are separately used for physiological saline injection and sample collection, respectively. The purpose is to provide an instrument.

In addition, since the microfluidic circuit is created to continuously transform the thrombus and break it into small pieces to move along the generated thrombus and collect the thrombus through an induction conduit, thrombi in blood vessels with a small diameter and tortuous path, such as cerebral vessels, can also be prevented. It can be effectively pulverized and removed, and since it is a fluid jet that directly acts on the blood vessel wall, not a material with high hardness such as metal, it is a blood vessel with a labyrinth septum capable of reopening blood flow in the blood vessel and creating a microflow circuit that can minimize damage to the blood vessel. The purpose is to provide an instrument.

In order to achieve the above object, the present invention is a vascular device capable of removing blood clots generated in blood vessels or collecting body fluid from a local blood vessel wall and delivering drugs,

a blood clot removal device formed in the form of a labyrinth septum capable of reopening blood flow within the blood vessel and generating a microflow circuit;

a drug delivery device formed in the thrombosis removal device and delivering a high-concentration drug transported from the outside to a blood vessel wall through a microflow circuit generated in the thrombosis removal device;

a local blood vessel wall body fluid collection device formed in the thrombosis removal device to collect body fluid stagnant in the blood vessel wall space and analyze the type and amount of intercellular transport substances in an in vitro analyzer provided outside the body;

It relates to a vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises.

In addition, the blood clot removal device of the present invention.

a body part that moves along a blood vessel to be located within the blood vessel where the thrombus is generated, performs a function of bypassing the blood flow in the blood vessel when installed, and introduces and transports the thrombus when suctioned;

a microflow circuit part connected to an end of the body part and provided to the outside of the body, and generating a microflow circuit to move, deform, and fragment the blood clot by applying microfluid to the blood clot;

Suction that is provided from the inside of the blood vessel to the outside of the body to block the blood flow in the blood vessel during the suction technique, and then suctions and discharges the blood clot that is moved, deformed, and fragmented by the microflow circuit unit and transported by the main body unit to the outside of the body wealth;

It relates to a vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises.

In addition, the main body portion of the present invention, and the outer tube through which both ends are cylindrical;

an inner tube formed in a cylindrical shape to be provided inside the outer tube and spaced apart from the inner surface of the outer tube;

It is formed vertically in the separation space formed between the inside of the outer tube and the outside of the inner tube to block both ends of the separation space through which the separation space penetrated and at the same time guide the microfluid of the microflow circuit unit transported to the separation space in various directions. Labyrinth bulkheads partitioning the separation space;

It relates to a vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises.

In addition, the cylindrical outer and inner tubes of the present invention are formed in a form in which the diameter changes so that the circumference is narrow in the anterior direction and wider in the rear direction in the moving direction, characterized in that the blood flow recanalization and microflow circuit creation in the blood vessel are formed. This relates to a vascular device having a labyrinth septum.

In addition, the plurality of labyrinth partitions of the present invention are formed in the separation space to divide the separation space into a plurality, and the use function is different for each of the plurality of separation spaces partitioned through the plurality of labyrinth partitions,

The plurality of separation spaces include a plurality of discharge spaces for discharging the microfluid transported from the microflow circuit unit to the outside of the main body unit, and a plurality of discharge spaces for discharging the microfluid transferred from the microfluid circuit unit to the inside of the inner tube by introducing blood clots moved, deformed, and fragmented by the microfluid. It relates to a vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it is partitioned into two through spaces.

In addition, a plurality of discharge holes communicating with the discharge space are formed on the outer surface of the outer tube of the present invention, where the discharge space of the separation space is located, so that the microfluid transported to the discharge space is sprayed onto the blood clots in the blood vessels through the discharge holes become,

A plurality of inlet holes are formed on the outer surface of the outer tube where the through space of the separation space is located to introduce blood clots moved, deformed, and fragmented by microfluids,

The inlet hole vertically penetrates the outer surface of the outer tube and the inner tube located in the through space to communicate with the inner side of the inner tube. It is about.

In addition, the microfluidic circuit unit of the present invention includes a microfluid transport pipe that is provided along the inside of the suction unit to the outside of the body in a state connected to the end of the rear cover unit of the main body unit, and transports a fine fluid therein to spray it on blood clots;

a microinjection pump that is connected to one end of a microfluid transport tube provided outside the body and injects a minute fluid into the micro fluid transport tube;

It relates to a vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises.

In addition, the suction part of the present invention has one side provided in the blood vessel to block the blood flow of the blood vessel, and the other side is provided outside the body, and the inside is formed through the inside to induce the microfluidic transfer pipe and various devices through the inside, , an inducing conduit for transporting blood clots outside the body;

a hub connected to an end of an induction conduit provided outside the body and connected to various devices;

a suction pump connected to one side of the hub to suck fluid, blood, and blood clots;

It relates to a vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises.

In addition, the induction conduit of the present invention,

with the tip;

an expansion unit formed on one side of the tip portion and capable of expanding and contracting the outside to directly block the inside of the blood vessel;

a body portion formed on one side of the expansion unit to induce expansion and contraction of the expansion unit;

an adjustment unit formed on one side of the body and connected to a hub on the other side to drive the body to the left and right to expand and contract the expansion unit;

It relates to a vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises.

In addition, the microinjection pump of the present invention is synchronized with the suction pump of the suction unit and operates simultaneously with the suction pump. It's about instruments.

As described above, the vascular device having a labyrinth septum capable of reopening blood flow within a blood vessel and generating a microflow circuit according to the present invention has functions such as thrombus removal, local drug delivery in the blood vessel wall, and body fluid collection in the local blood vessel wall. More specifically, by reopening the blood flow in the blood vessel and creating a microfluidic circuit through multiple side holes, continuous suction of the clot is possible, and the clot is broken or broken into small pieces to cleanly remove it. (1) Thrombus removal device and microfluidic circuit without interruption of blood flow while securing an intravascular bypass when it is necessary to precisely deliver drugs or cells locally by targeting lesions on the blood vessel wall (2) Local drug delivery device for blood vessel wall, which can perform local drug delivery procedure on the blood vessel wall by keeping high-concentration drug or cell-containing fluid on the blood vessel wall for a long time, and for component analysis for precise local drug delivery It is possible to analyze the concentration of intercellular signaling substances such as exosomes, microRNA, cytokine, and peptides from samples collected from within blood vessels adjacent to vascular lesions such as atherosclerotic plaques, vascular dissections, and cerebral aneurysms, thereby studying the intercellular signaling system. B. It is an intravascular device for collecting body fluid from the local blood vessel wall where the type and dose of the administered drug can be determined. In this case, among the components of the microfluidic circuit, a plurality of fluid injection passages and outer holes are provided so that they can be separately used for physiological saline injection and sample collection.

In addition, since the microfluidic circuit is created to continuously transform the thrombus and break it into small pieces to move along the generated thrombus and collect the thrombus through an induction conduit, thrombi in blood vessels with a small diameter and tortuous path, such as cerebral vessels, can also be prevented. It can be effectively pulverized and removed, and since it is a fluid jet, not a material with high hardness such as metal, that directly acts on the blood vessel wall, there is an effect of minimizing blood vessel damage.

1 is a schematic diagram showing the configuration of a vascular device according to an embodiment of the present invention;
2 is a schematic diagram showing a vascular device installed and operating in a blood vessel according to an embodiment of the present invention;
3 is a front view showing a body part and a microflow circuit part according to an embodiment of the present invention;
4 is a conceptual diagram showing the operation of the body part and the microflow circuit part according to an embodiment of the present invention;
5 is a cross-sectional view showing a main body according to an embodiment of the present invention;
6 is a vertical cross-sectional view showing a main body according to an embodiment of the present invention;
7 is a plan view showing an unfolded main body according to an embodiment of the present invention;
8 is a schematic diagram showing a suction unit according to an embodiment of the present invention;
9 is an operation diagram showing the operation of FIG. 8;
10 is a schematic diagram showing a hub according to an embodiment of the present invention;
11 is a step diagram illustrating an operating method of the thrombus removal device according to an embodiment of the present invention.

The present invention having such characteristics will be more clearly explained through the preferred embodiments thereof.

Before describing various embodiments of the present invention in detail with reference to the accompanying drawings, it will be appreciated that the application is not limited to the details of the configuration and arrangement of components described in the following detailed description or shown in the drawings. will be. The invention is capable of being implemented and practiced in other embodiments and of being carried out in various ways. Also, device or element orientation (e.g., "front", "back", "up", "down", "top", "bottom") The expressions and predicates used herein with respect to terms such as ", "left", "right", "lateral", etc. are only used to simplify the description of the present invention and related devices. Or it will be appreciated that it does not indicate or imply that an element simply must have a particular orientation. Also, terms such as “first” and “second” are used herein and in the appended claims for descriptive purposes and are not intended to indicate or imply relative importance or significance.

Therefore, since the embodiments described in this specification and the configurations shown in the drawings are only one of the most preferred embodiments of the present invention and do not represent all of the technical ideas of the present invention, various alternatives may be used at the time of this application. It should be understood that there may be equivalents and variations.

1 is a schematic diagram showing the configuration of a vascular device according to an embodiment of the present invention, FIG. 2 is a schematic diagram showing a vascular device installed and operating in a blood vessel according to an embodiment of the present invention, and FIG. It is a front view showing the body part and the microflow circuit according to one embodiment, Figure 4 is a conceptual diagram showing the operation of the body part and the microflow circuit according to one embodiment of the present invention, Figure 5 is in one embodiment of the present invention Figure 6 is a vertical cross-sectional view showing the main body according to an embodiment of the present invention, Figure 7 is a plan view showing the unfolded body according to an embodiment of the present invention, Figure 8 is a plan view showing the main body according to the present invention A schematic diagram showing the suction unit according to an embodiment of the, Figure 9 is an operation diagram showing the operation of Figure 8, Figure 10 is a schematic diagram showing a hub according to an embodiment of the present invention, Figure 11 is an embodiment of the present invention It is a step diagram showing the operation method of the thrombus removal device according to the example.

As shown in FIGS. 1 to 11, the vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit according to the present invention includes a thrombus removal device, a local blood vessel wall drug delivery device, and a local blood vessel wall It consists of a body fluid collection device.

As shown in FIGS. 1 to 11, the blood clot removal device 400 is a device for removing a blood clot 2 generated in a blood vessel 1, and includes a body portion 10, a microflow circuit portion, and a suction portion. It consists of

As shown in FIGS. 1 to 7 , the main body 10 is moved and installed along the blood vessel 1 so as to be located within the blood vessel 1 occluded by the thrombus, thereby reopening the blood flow in the blood vessel 1 create a state For thrombus aspiration, the thrombus 2 moved, deformed, and fragmented through the creation of a microfluidic circuit in a state where blood flow is stopped is introduced and transported to the suction unit. At this time, the body portion 10 is formed of a material such as a flexible and soft material capable of minimizing damage to the blood vessel 1 or a material such as a Nitinol alloy having a self-expansion property.

Here, the body portion 10 is formed in a cylindrical shape so as to be provided inside the outer tube 11 and the outer tube 11 through which both ends and the hollow inside are penetrated, and the outer tube 11 The inner pipe 12, in which a space is formed by being spaced apart from the inner surface, is formed vertically in the spaced space formed between the inner side of the outer pipe 11 and the outer side of the inner pipe 12, and both ends of the spaced space penetrated. It is composed of a labyrinth barrier 13 that partitions the separation space to block the separation space and to guide the microfluid of the microflow circuit part transported to the separation space in various directions.

In addition, the cylindrical outer tube 11 and the inner tube 12 are formed in a shape in which the diameter changes so that the circumference at the front is narrow in the moving direction and the circumference is formed wider toward the rear, and the labyrinth partition wall 13 is cylindrical. It is formed to block the spaced-off space penetrating both ends of the outer tube 11 and the inner tube 12, and the labyrinth partition wall 13 at that part is formed in a circular ring shape to block the spaced-apart space.

In addition, a plurality of the labyrinth partition walls 13 are formed in the separation space to divide the separation space into a plurality, and each of the plurality of separation spaces partitioned through the plurality of labyrinth partition walls 13 has a different use function. The plurality of separation spaces include a plurality of discharge spaces 14 for discharging the microfluid transferred from the microfluid circuit to the outside of the main body 10, and blood clots 2 moved, deformed, and fragmented by the microfluid inflow. It is divided into a plurality of through spaces 15 that are transferred to the inside of the inner tube 12 and are partitioned. At this time, the plurality of through spaces 15 are formed between the plurality of discharge spaces 14 and are partitioned by the labyrinth partition wall 13 .

Here, as shown in FIG. 7 , the labyrinth barrier 13 is formed to be zigzag and curved, so that microfluids can be transferred in various directions, and thus microfluids can be evenly transferred and at the same time, the discharge hole 17 is opened. It can be sprayed evenly outside. At this time, the planar shape of the labyrinth barrier 13 is formed in various shapes so that the microfluid can be transported in various directions.

As such, the labyrinth partition wall 13 is formed between the outer labyrinth partition wall 13a blocking the spaced space penetrating both ends of the cylindrical outer tube 11 and the inner tube 12 and the spaced space to provide a plurality of spaced spaces. It is divided into an inner labyrinth partition 13b that divides the dog discharge space 14 and the through space 15. At this time, the outer labyrinth partition wall 13a located on the rear surface of the cylindrical outer tube 11 and the inner tube 12 among the outer labyrinth partition walls 13a is connected so as to communicate with the microfluid transport tube 21 of the microflow circuit part, The microfluid of the flow circuit is transferred to the discharge space 14 .

Here, as shown in FIGS. 6 and 7, the microfluid of the microflow circuit introduced through the outer labyrinth partition 13a is formed to be blocked by the inner labyrinth partition 13b so that it is not transferred to the through space 15, so that the microfluid It is transported only to the discharge space (14).

On the other hand, a plurality of discharge holes 17 communicating with the discharge space 14 are formed on the outer surface of the outer pipe 11, where the discharge space 14 of the spaced space is located, and transported to the discharge space 14. The microfluid is sprayed onto the blood clot 2 in the blood vessel 1 through the discharge hole 17 .

In addition, on the outer surface of the outer tube 11, where the through space 15 of the spaced space is located, a plurality of inlet holes 18 are provided to introduce the blood clots 2 that are moved, deformed, and fragmented by microfluids. is formed

In addition, the inlet hole 18 vertically penetrates the outer surface of the outer tube 11 and the inner tube 12 located in the through space 15 to communicate with the inside of the inner tube 12, that is, the inlet The hole 18 is formed on the same vertical line of the outer tube 11 and the inner tube 12, and the through space 15 is located in the middle. As such, the moved, deformed, and fragmented blood clots 2 introduced through the inlet hole 18 pass through the inner tube 12 and are delivered to the suction unit through the inner side of the inner tube 12, and through the suction unit excreted out of the body.

As shown in FIGS. 1 to 5, the microflow circuit is attached to the end of the main body 10 and is provided to the outside of the body, and transfers fine fluid to move, deform, and fragment the blood clot 2 It consists of a microfluid transfer pipe 21 and a microinjection pump 22 to create a microflow circuit.

The microflow circuit is basically a circuit based on the flow of physiological saline, but a microflow circuit can be configured as a fluid to which antiplatelet agents such as tirofiban and abciximab, anticoagulants such as heparin, and thrombolytic agents such as tissue plasminogen activator (tPA) and urokinase are added. there is.

Here, the microfluid transport pipe 21 is provided to the outside of the body along the inside of the inlet in a state of being attached to communicate with the outer labyrinth partition 13a of the main body 10, and the inside of the micro fluid transport pipe 21 The fine fluid injected through the microinjection pump 22 is transported and injected into the blood clot 2.

In addition, one or more microfluid transfer tubes 21 are formed. A plurality of microfluid transfer tubes 21 may be formed according to the number of connectors of the outer labyrinth partition wall, and the plurality of microfluid transfer tubes 21 extend to the outside of the body along the inside of the inlet. are provided

In addition, the microinjection pump 22 is connected to one end of the microfluidic transfer pipe 21 provided outside the body and controls the microfluid injection into the microfluid transfer tube 21 .

Here, the micro-injection pump 22 is synchronized with the suction pump 300 of the suction unit and operates simultaneously when the micro-injection pump 22 is operated or when the suction pump 300 is operated. At this time, the reason why it should work together is described below.

As shown in FIGS. 1 to 2 and 8 to 10, the suction unit is provided from inside the blood vessel 1 to the outside of the body to block the blood flow of the blood vessel 1 during the suction procedure, and then the microflow Consists of an induction conduit 100, a hub 200, and a suction pump 300 to suction and discharge the blood clots 2 moved, deformed, and fragmented by the circuit part and transported by the body part 10 to the outside. .

The induction conduit 100 has one side provided inside the blood vessel 1 to block the blood flow of the blood vessel 1, and the other side provided outside the blood vessel 1, and the inside is formed to pass through, so that the microfluid can pass through the inside. It induces the pipeline 21 and other intravascular devices, and is configured to suction and remove blood clots, blood, and fluids when the blood flow is blocked by the expansion of the expansion part. That is, the tip portion 110, the expansion portion 120 formed on one side of the tip portion 110 and allowing the outside to expand and contract to directly block the inside of the blood vessel 1, and the expansion portion 120 The body portion 130 is formed on one side of the body portion 130 to induce expansion and contraction of the expansion portion 120, the body portion 130 is formed on one side of the body portion 130, and the other side is connected to the hub 200 to form the body portion 130 It is composed of a control unit 140 that expands and contracts the expansion unit 120 by driving the longitudinal axis forward and backward.

Here, the tip 110 is formed in a cylindrical shape at the very end of the induction conduit 100 to guide the microfluidic transport tube 21 and other intravascular devices through the inside, and blood clots, blood, and fluids to be suctioned off, and the tip 110 has a cylindrical shape with a narrow or constant diameter so that the diameter gradually decreases toward the front of the induction conduit 100 to facilitate navigation when advancing in the moving direction, and is flexible. It is composed of a flexible material and is easy to navigate through the vascular system (1).

In addition, the expansion part 120 is formed between the tip part 110 and the body part 130 and is expandable, and has a balloon section or expansion section that is in close contact with the inner wall of the blood vessel 1 to block the blood vessel 1. The expansion part 120 is composed of a skeleton such as a strut or wire and an elastic film surrounding it, and the front end of the strut structure of the expansion part 120 is fixed to the tip end 110, and the expansion part ( The rear end of the strut structure of 120) is fixed to the body portion 130, and the expansion portion 120 has a plurality of pins formed along the circumferential and longitudinal directions of the cylindrical shape, and a wire made of superelastic shape memory alloy or titanol material. It is manufactured by weaving or crossing wires to each pin in the circumferential and longitudinal directions of the stent manufacturing jig to form a net shape with a plurality of spaces, so that the length of the expansion part 120 is adjusted in the front and rear directions It expands or contracts at the same time, and the outer diameter of the expansion part changes.

In addition, the body portion 130 has a monorail capable of sliding a wire on an inner wall, and one end of the monorail wire is fixed to the expansion unit 120, and the other end of the wire is adjustable. It is fixed to part 140.

In addition, when the body part 130 moves along the wire, the control part 140 is made of a gear wheel that controls this action, and the control part 140 is placed between the body part 130 and the hub 200. are provided in At this time, as the gear wheel rotates in a spiral, the body 130 is operated forward and backward while pushing and pulling the wire, and at the same time, the expansion unit 120 is operated forward and backward, so that the diameter of the expansion unit 120 is increased. It expands and contracts as it grows and shrinks.

The hub 200 is connected to the end of the induction conduit 100 provided outside the body to connect to various devices. (B), the suction pump port (D), the central chamber (C), and the microflow circuit port (A2) are formed to connect. At this time, a sensor for detecting the presence of air is further installed inside the hub 200 so that air can be removed by the sensor.

The suction pump 300 is connected to one side of the hub 200 to suck fluid, blood, and blood clots 2. When sucking, the suction force is transmitted to the inside of the main body 10 to act as a negative pressure. Blocking blood flow by the expansion of the expansion part serves to prevent the thrombus (2) from embolizing to the distal part of the blood vessel (1), and provides a closed space during suction of the thrombus (2), so that negative pressure is stably applied to the body part (10). ) to generate a secondary fluid jet of the inlet hole 18.

As shown in FIGS. 1 and 4, the local blood vessel wall drug delivery device 500 allows a high concentration of drug or cells to stay on the blood vessel wall for a long time through a microfluidic circuit created without interruption of blood flow, resulting in a localized blood vessel wall effective drug delivery is possible.

Here, in vascular diseases such as atherosclerosis, vascular dissection, and cerebral aneurysm, there is an effect of locally delivering high-concentration drugs or cells to the blood vessel wall. For example, in the case of thrombosis of the vascular segment and vascular occlusion due to rupture of the atherosclerotic plaque, activation and aggregation of platelets continue to occur, so vascular recanalization cannot be maintained only by thromboplasty, additional balloon angioplasty, stent insertion, and antiplatelet agents administration of, etc.

In addition, in the case of acute cerebral infarction, the blood-brain barrier is weakened, so the use of drugs such as thrombolytic agents and antiplatelet agents is limited. Therefore, permanent stent implantation and antiplatelet agent administration necessary for maintaining patency are not recommended for cerebral hemorrhagic transformation. It is difficult to implement because there are many cases where it cannot be administered to lower it. Antiplatelet agents (tirofiban, abciximab), anticoagulants (heparin, NOAC), thrombolytic agents (tPA (tissue plasminogen activator), urokinase), stent restenosis prevention drugs (paclitaxel, rapamycin), etc., so that it has an effect that can be precisely administered locally to the blood vessel wall at a set speed and dose.

In addition, the local blood vessel wall drug delivery device 500 allows a high-concentration drug or cells to stay on the blood vessel wall for a long time through a microfluidic circuit created without interruption of blood flow. As a result, drug delivery is possible locally to the blood vessel wall. Typically, in vascular diseases such as atherosclerosis, vascular dissection, and cerebral aneurysm, high-concentration drugs or cells are delivered locally to the vessel wall.

On the other hand, for obtaining a blood vessel wall image, iodine nanoparticles (CT image) or gadolinium nanoparticles or iron oxide nanoparticles (MRI image ) is administered through a fluid infusion pump at a predetermined infusion speed and volume, and a three-dimensional image of the vessel wall can be acquired. For the diagnosis of pathophysiology of the blood vessel wall, such as atherosclerotic plaque, arterial dissection, and cerebral aneurysm, 3D blood vessel wall imaging plays a role in precise diagnosis, post-treatment response evaluation, and prognosis prediction.

As shown in FIGS. 1 and 4, the local blood vessel wall body fluid collection and component analysis device 500 is a tool for local blood vessel wall body fluid collection and component analysis and drug delivery, and is a device for reopening porous blood flow and generating microflow circuits. , porous devices such as porous microwires can be used. Local blood vessel wall fluid collection and component analysis device for intercellular transport substance analysis. Place the above device in an artery or vein to perform local blood vessel wall fluid collection and component analysis. It is possible to study signal transduction system. By analyzing intercellular signaling substances in the blood vessel wall using techniques such as microdialysis and exsome microarray, the type and dose of drugs administered can be adjusted.

Here, a fluid such as physiological saline or PBS is slowly injected through the microinjection passage for cleaning, and the fluid delivered through the outer hole stays in the outer lumen of the porous device for a certain period of time. At this time, the injected physiological saline dissolves the transporter (for example, exosome, microRNA, cytokine, peptide, etc.) on the blood vessel wall.

In addition, the extraluminal space of the porous device is a space between the functional part of the device and the vessel wall, and the intercellular transport material of the vessel wall potentially exists. Trace amounts of cellular transport substances may be dissolved and collected in the infusion fluid, which may reflect the pathophysiological condition.

Typically, intercellular transport substances such as exosome, paracrine hormone, neurotransmitter, and cytokine are collected and recovered through a microinjection passage, and the pathoecological state of the blood vessel wall can be evaluated by measuring the type and amount of intercellular transport substances.

In addition, fluids such as physiological saline and PBS are slowly injected through the microinjection passage for cleaning, and the fluid delivered through the outer hole stays in the outer lumen space of the porous device for a certain period of time and is injected into the physiological saline solution into which the transmitter of the blood vessel wall is injected. melts

As such, the device according to the present invention may include a plurality of microflow circuits opening to outward holes. For example, physiological saline is injected through a microflow circuit opening to the outer hole 1 and allowed to stay there. Physiological saline stagnant in the instrument-vessel wall space is collected through the microflow circuit opening through the outer hole 2, and the type and amount of intercellular transport substances are analyzed in an in vitro analyzer. By synchronizing these multiple microflow circuits, physiological saline or drugs can be placed in the space between the device and the vessel wall in a state of intravascular blood flow reopening for a predetermined time in a dynamic equilibrium state without distal loss or embolization.

Here, it is possible to determine the type and dose of a drug to be locally administered to the blood vessel wall through local blood vessel wall body fluid collection and component analysis. For example, fluid injection passage 1 is used for physiological saline injection and fluid injection passage 2 is used for sample collection, to analyze intercellular signaling substances in the blood vessel wall through techniques such as microdialysis and exsome microarray, and to determine the effect of the administered drug. The type and capacity can be precisely controlled in real-time or time-series fashion. Representatively, in the case of thrombotic vascular occlusion due to rupture of atherosclerotic plaque, platelet function hyperactivity, atherosclerosis-related cytokine, matrix metalloproteinase (MMP), elastase, inflammation-related peptides such as myeloperoxidase, and concentrations of thrombin-inducing thrombin are measured in real time or time series. It is possible to determine the dosage and speed of administration of antiplatelet agents, anti-inflammatory agents, stem cell preparations, and thrombolytic agents by measuring.

And, in addition to simply tracking pathological changes through local blood vessel wall fluid collection and component analysis, it is possible to determine the type and dose of the administered drug through local blood vessel wall fluid collection and component analysis. For example, two of the plurality of fluid injection passages can be used for physiological saline solution injection and two for sample collection.

In addition, by adjusting the speed/pressure/amount of the fluid injection passage and the suction passage, both are balanced, and through the resulting fluid circuit, local blood vessel wall body fluid collection and component analysis, and local blood vessel wall drug delivery are possible. do.

Hereinafter, with reference to FIG. 11, the method of operating the thrombosis removal device of the present invention described above will be described step by step in detail.

Step 1) Induction conduit installation

In order to remove the thrombus 2 occluding the blood vessel 1, the distal dilatation conduit 100 is placed at the inlet of the target blood vessel 1.

Step 2) Microfluid supply and intravascular advancement

As a preparation step for the blood clot 2 removal operation, the surface of the vascular device is treated with hydrophilicity by supplying fluid from the microinjection pump 22 . By controlling whether and how much fluid is supplied to the microflow circuit, the vascular device is prevented from being attached to the wall of the blood vessel (1) while maintaining the position within the blood vessel (1), and moves forward with low frictional force to reach the target blood vessel (1) section. Provide a distal portion that is more flexible than a proximal portion to facilitate navigation/advance/manipulation of a vascular device through the vasculature.

The vascular device of the present invention is inserted through the inside of the induction conduit 100 and then moved forward so that the body portion 10 and the microflow circuit portion advance out of the induction conduit 100. The vascular device advances concentrically with the guide wire or approaches the section of the target blood vessel 1 by using the frictional force reduction by controlling the fluid supply of the fluid flow circuit.

Step 3) Immediate endovascular flow bypass

The vascular device is inserted into the distal dilatation induction conduit 100 and advanced to the section of the blood vessel 1 where the thrombus 2 is occluded. At the same time as the vascular device is installed in the thrombus (2) section, the thrombus (2) is pushed into the space between the vascular device and the wall of the blood vessel (1), and blood flow is immediately reopened through the lumen of the vascular device. When the functional part of the instrument is positioned to cover the entire section of the thrombus 2, the thrombus 2 blocking the blood vessel 1 can be displaced to the side of the wall of the blood vessel 1. The thrombus 2 pushed out by the functional part of the vascular apparatus located in the thrombus 2 section is displaced in the space between the vascular apparatus and the wall of the blood vessel 1. Meanwhile, the blood flow occupying the center of the cross section of the blood vessel 1 passes through the entire section of the thrombus 2 through the reopening of blood flow in the blood vessel 1 .

Step 4) Generation and operation of microfluidic circuits

In a state in which blood flow is stopped by increasing the outer diameter of the expansion part 120 of the induction conduit 100, the synchronized microinjection pump 22 and the suction pump 300 are operated to generate a microfluidic circuit. Fluid such as physiological saline injected from the microinjection pump 22 passes through the microfluidic transfer pipe 21 of the support part and moves to the microfluidic transfer pipe 21 of the functional part, and the discharge hole 17 of the microfluid transfer pipe 21 ) through which it is injected into the space between the blood vessel apparatus and the wall of the blood vessel (1).

At this time, when the fluid is injected by operating the microinjection pump 22 in the fluid injection system, the pressure of the fluid is transmitted to the discharge hole 17 through the microfluid transfer pipe 21, It flows along the fluid transport pipe 21, and the microfluid transported through the micro fluid transport pipe 21 is transferred to the spaced space of the main body 10, and then a fluid jet is generated through the discharge hole 17 of the outer pipe. while spraying into the space between the blood vessel apparatus and the wall of the blood vessel (1).

Water content increase, viscoelasticity change, deformation, abrasion, splitting, etc. occur in the blood clot due to the jet flow generated on the outer surface of the vascular device/physiological saline water jet through the discharge hole 17, and correspondingly, the suction part is induced Jet flow and fluid generated through a plurality of inlet holes 18 and discharge holes 17 provided between the lumen and the outer lumen of the blood vessel device by generating a suction force through the conduit 100 to reduce clots that have become smaller due to deformation, abrasion, etc. As it moves along the circuit, it deforms and aspirates more and more clots. Blood clots are removed metallurgically through sequential deformation while moving along the microfluidic circuit.

In addition, the suction pump 300 operates simultaneously with the microinjection pump 22 . Continuous suction is performed in the suction pump 300 connected to the induction conduit 100, and negative pressure is generated in the entire path of the blood vessel 1 including the lumen of the blood vessel device. Physiological saline solution (fluid) injected by the microinjection pump 22 by this negative pressure enters the lumen of the vascular device through the inlet hole 18 of the main body 10, and at this time, the finely crushed blood clot 2 At the same time, it is sucked into the suction pump 300 through the induction pipe 100.

Here, as the clot 2 is pushed out of the discharge hole 17 by the jet fluid or sucked into the inlet hole 18, the torn and small clot 2 moves. In order to increase the suction power, the outer diameter of the induction conduit 100 for suction is increased by inflating the expansion part 120, and the outer wall of the induction conduit 100 is brought into close contact with the inner wall of the blood vessel 1 to stop the flow to form a closed space. do.

In the state where the blood flow is stopped, suction of the suction pump 300 connected to the hub 200 starts, and the generated negative pressure propagates to the central lumen of the vascular device. The negative pressure in the lumen of the induction conduit 100 creates a fluid jet in the inward direction of the microfluidic transfer tube 21 of the present invention and forms a microfluidic circuit. The negative pressure in the lumen of the vascular device generates a fluid jet between the outer lumen and the outer lumen of the vascular device through the inlet hole 18 formed on the outer surface of the main body 10, causing fragmentation and movement of the thrombi 2. The blood clot 2 is miniaturized in the form of fragments by riding the fluid jet, and while the blood clot 2 moves, it is fragmented by being caught in the inlet hole 18 or deformed into small pieces to pass through the hole and move.

Step 5) Recovery of vascular apparatus

In order to complete the suction process through the microcircuit, suction of the microinfusion pump 22 and suction of the suction pump 300 are simultaneously performed on the vascular device placed in the section of the blood vessel (1) concentrically with the induction conduit (100). While doing so, the vascular apparatus is gradually recovered outside the body. effective without interruption In order to provide the suction power of the microflow circuit, an additional suction conduit is coaxially installed inside the induction conduit 100, located in the thrombus 2 section, and a suction pump 300 is connected to the suction conduit and the vascular device. It can be slowly eliminated from the body in one unit. This method has the advantage of recovering the vascular device while maintaining the microfluidic circuit by the synchronized operation of the microinjection pump 22 and the suction pump 300 during the entire recovery process.

10: body part 11: outer tube
12: inner tube 13: labyrinth septum
13a: outer labyrinth partition 13b: inner labyrinth partition
14: discharge space 15: through space
17: discharge hole 18: inlet hole
21: microfluid transport pipe 22: microinjection pump
23: discharge hole
100: induction conduit 110: tip
120: expansion part 130: body part
140: control unit
200: hub 300: suction pump
400: blood clot removal device
500: Drug delivery device or local blood vessel wall body fluid collection and component analysis device

Claims (10)

In a vascular device capable of removing a blood clot generated in a blood vessel or collecting body fluid from a local blood vessel wall and delivering a drug,
a blood clot removal device formed in the form of a labyrinth septum capable of reopening blood flow within the blood vessel and generating a microflow circuit;
a drug delivery device formed in the thrombosis removal device and delivering a drug transported from the outside to a blood vessel wall through a microflow circuit generated in the thrombosis removal device;
A local blood vessel wall body fluid collection device that is formed in the thrombosis removal device and collects body fluid stagnant in the blood vessel wall space and transfers it to an in vitro analyzer provided outside the body to analyze the type and amount of intercellular transport material; including constituted,
The thrombus removal device is moved along the blood vessel 1 so as to be positioned within the blood vessel 1 where the thrombus has occurred, performs a function of reopening the blood flow in the blood vessel 1 when installed, and removes the thrombus 2 when inhaled. A main body portion 10 for inflowing and transporting;
a microflow circuit part connected to the end of the body part 10 and provided to the outside of the body, and generating a microflow circuit to move, deform, and fragment the blood clot by applying microfluid to the blood clot;
Blood clots are provided from inside the blood vessel (1) to the outside of the body to block the blood flow of the blood vessel (1) during the inhalation technique, and then are moved, deformed, and fragmented by the microflow circuit unit and transported by the main body portion (10) (2) is inhaled and discharged to the outside of the body; is configured to include,
The main body portion 10 includes an outer tube 11 through which both ends and a hollow interior pass through in a cylindrical shape;
An inner tube 12 formed in a cylindrical shape to be provided inside the outer tube 11 and spaced apart from the inner surface of the outer tube 11 to form a space;
It is formed vertically in the separation space formed between the inner side of the outer tube 11 and the outer side of the inner tube 12 to block the penetrating ends of the separation space and at the same time, the microfluid of the micro-flow circuit part transported to the separation space. a labyrinth partition wall 13 partitioning the spaced apart space to induce them in various directions;
A vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises a.
delete delete According to claim 1,
The cylindrical outer tube 11 and the inner tube 12 are formed in a form in which the diameter changes so that the circumference in the front is narrow in the moving direction and the circumference is widened toward the rear, characterized in that Vascular apparatus with a labyrinth septum capable of generating
According to claim 1,
A plurality of the labyrinth partition walls 13 are formed in the spaced space to divide the spaced space into multiple pieces, and each of the plurality of spaced spaces partitioned through the plurality of labyrinth partition walls 13 has a different use function.
The plurality of separation spaces include a plurality of discharge spaces 14 for discharging the microfluid transported from the microfluid circuit to the outside of the main body 10 and blood clots 2 moved, deformed, and fragmented by the microfluid. A vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it is partitioned into a plurality of through spaces (15) that are introduced and transported to the inside of the inner tube (12).
According to claim 5,
A plurality of discharge holes 17 communicating with the discharge space are formed on the outer surface of the outer pipe 11 where the discharge space 14 of the spaced space is located, and the microfluid transferred to the discharge space 14 is discharged. It is injected into the blood clot 2 in the blood vessel 1 through the hole 17,
A plurality of inlet holes 18 are formed on the outer surface of the outer tube 11, where the through space 15 of the separation space is located, to introduce the blood clots 2 moved, deformed, and fragmented by microfluids, ,
The inlet hole 18 vertically penetrates the outer surface of the outer tube 11 and the inner tube 12 located in the through space 15 to communicate with the inner side of the inner tube 12, characterized in that A vascular device with a labyrinth septum capable of recanalization and creation of microflow circuits.
According to claim 1,
The microflow circuit unit,
A microfluid transport tube 21 connected to the rear surface of the labyrinth partition wall 13 of the main body unit 10 and provided to the outside of the body along the inside of the suction unit, transporting fine fluid therein and spraying it to the blood clot 2; ;
a microinjection pump 22 connected to one end of the microfluid transport pipe 21 provided outside the body and injecting a fine fluid into the micro fluid transport pipe 21;
A vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises a.
According to claim 7,
the suction part,
One side is provided in the blood vessel 1 to block the blood flow of the blood vessel 1, and the other side is provided outside the body, and the inside is formed to penetrate to induce the microfluidic transfer pipe 21 and various devices through the inside. and an induction conduit 100 for transferring the thrombus 2 to the outside of the body;
a hub 200 connected to an end of the induction conduit 100 provided outside the body and connected to various devices;
a suction pump 300 connected to one side of the hub 200 to suck fluid, blood, and blood clots 2;
A vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises a.
According to claim 8,
The induction conduit 100,
With the cutting edge 110;
an expansion part 120 formed on one side of the tip part 110 to directly block the inside of the blood vessel 1 by allowing the outside to expand and contract;
a body portion 130 formed on one side of the expansion unit 120 to induce expansion and contraction of the expansion unit 120;
An adjustment unit 140 formed on one side of the body 130 and connected to the hub 200 on the other side to drive the body 130 left and right to expand and contract the expansion unit 120;
A vascular device having a labyrinth septum capable of reopening blood flow in a blood vessel and generating a microflow circuit, characterized in that it comprises a.
According to claim 8,
The microinjection pump 22 is synchronized with the suction pump 300 of the suction unit and operates simultaneously with the suction pump 300. Vascular apparatus with labyrinth septa.

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