KR102428946B1 - Drug delivery device and method of drug delivering using the same - Google Patents

Abstract

The present invention relates to a drug delivery device and a drug delivery method using the same. According to an embodiment of the present invention, it comprises a microneedle device attached to the treatment site to deliver a drug and a coil-type stent for fixing the microneedle device while surrounding the treatment area to which the microneedle device is attached. do it with

Description

Drug delivery device and method of drug delivery using the same

The present invention relates to a drug delivery technology, and more particularly, to a drug delivery device and a drug delivery method using the same.

Atherosclerosis is a cardiovascular disease that adversely affects the heart and blood vessel tissues by causing stenosis or occlusion of the vascular tissue due to the rupture of a hard plaque formed by the accumulation of cholesterol on the inner wall of the blood vessel. In addition, when myocardial ischemia occurs in the heart tissue by the hard plaque, serious diseases such as heart attack may occur. In order to treat ischemic heart disease such as myocardial ischemia resulting from atherosclerosis, medical procedures such as angioplasty and stenting or surgical operations such as coronary artery bypass grafting and endarterectomy may be performed. However, the surgical drug delivery method may cause vascular endothelial damage, and may cause stenosis or occlusion of blood vessels due to neointimal hyperplasia (IH), particularly at the site where the stent is mounted or at the site of the graft anastomosis. . In addition, in the case of a dialysis patient, in an arteriovenous fistula that connects an artery and a vein, the surgical drug delivery method is likely to cause neointimal hyperproliferation due to damage to vascular endothelial cells at the anastomosis site.

In order to prevent the neointimal hyperplasia, various blood vessel outer wall drug delivery devices for delivering anti-proliferation drugs by binding to vascular tissue have been developed. Among them, a drug delivery device for cardiovascular disease treatment using a microneedle (MN) shows high drug delivery efficiency and excellent therapeutic effect. In order to stably fix the microneedle device to the outer wall of the blood vessel when the drug delivery device using the microneedle is applied, a fixing device such as an external tube or a surgical clip is used. Unlike the conventional external tube or surgical clip, the microneedle is made of a non-biodegradable material, unlike the biodegradable material. causing side effects.

Korean Patent Publication No. 10-1241059

The technical problem to be solved by the present invention is drug delivery that not only has excellent drug delivery efficiency for treatment of the treatment site, but also can be stably and easily fixed to the treatment site, and can be decomposed in the body after a predetermined time has elapsed to provide the device.

In addition, another technical problem to be solved by the present invention is to provide a drug delivery method using the drug delivery device that has the above advantages and can be easily mounted on a treatment site.

According to an embodiment of the present invention, a drug comprising a microneedle device attached to a treatment site to deliver a drug, and a coil-type stent for fixing the microneedle device while surrounding the treatment site to which the microneedle device is attached A delivery device may be provided.

In one embodiment, the coil-type stent is inserted into the treatment site to which the microneedle device is attached between the pitch of the first winding portion adjacent to the end of the coil-type stent, rotates, and surrounds the microneedle device and is fixed can do it In an embodiment, the treatment site may include any one of a vascular injury site, an anastomosis site, and a graft.

In one embodiment, the microneedle device may be composed of at least one of a biodegradable material and a biocompatible material. In another embodiment, the microneedle device includes a body part and a microneedle formed on one side of the body part, and the body part may include any one of a continuous film shape, a cuff shape, and a mesh shape. can

In one embodiment, the coiled stent has a first modulus of elasticity in the longitudinal direction of the coiled stent, the coiled stent has a second modulus of elasticity in the radial direction of the coiled stent, the first of the coiled stent The elastic modulus may be greater than the second elastic modulus. In another embodiment, the coiled stent may have a coil end shape corresponding to any one of abutted end, open end, open end, or tangential tail end.

In one embodiment, the coiled stent may be composed of at least one of a biodegradable material and a biocompatible material. In another embodiment, the coiled stent may be composed of at least one of a biodegradable material and a biocompatible material that biodegrades or disappears later than the microneedle device.

In one embodiment, the pitch interval of the coiled stent may be less than or equal to the diameter of the treatment site. In another embodiment, the pitch interval of the coiled stent may be greater than the diameter of the treatment site. In another embodiment, a drug may be further added to the exposed surface of the coiled stent.

In one embodiment, the coil-type stent may further include an anchor on at least one of an end or an inner peripheral surface of the stent. In another embodiment, the anchor may consist of at least one of a spike and a needle nose. In another embodiment, the anchor may be composed of at least one of a biodegradable material and a biocompatible material.

In one embodiment, the coiled stent wire rod of the coiled stent may include a cross-sectional area of any one of a circle, a square, a rectangle, an ellipse, a triangle, a trapezoid, a rhombus, and a star shape. In one embodiment, the cross-sectional thickness (t) of the coiled stent is in the range of 50.0 μm to 2.0 mm, the diameter (D1) of the coiled stent is in the range of 500 μm to 30.0 mm, the diameter of the coiled stent The ratio of (D1) and the cross-sectional thickness (t) is in the range of 10 to 600, the number of pitches of the coiled stent is in the range of 3 to 300, and the separation distance (D2) between pitches of the coiled stent is 0.1 mm To have a range of 10 mm, the pitch interval of the coil-type stent may have a range of 10% to 50% of the treatment site.

According to an embodiment of the present invention, there is provided a drug delivery method using a drug delivery device, comprising the steps of attaching a microneedle device to a treatment site and fixing the microneedle device while surrounding the treatment site to which the microneedle device is attached. It is possible to provide a drug delivery method comprising the step of mounting a coiled stent. In another embodiment, the step of mounting the coiled stent is inserted into the treatment site to which the microneedle device is attached between the pitch of the first winding adjacent to the end of one side of the coiled stent, and the coiled stent is inserted into the coil. The microneedle device may be fixed by rotating it in the spiral direction to surround the treatment site to which the microneedle device is attached. In another embodiment, the coiled stent has a first modulus of elasticity in the longitudinal direction of the coiled stent, the coiled stent has a second modulus of elasticity in the radial direction of the coiled stent, The first elastic modulus may be greater than the second elastic modulus. In another embodiment, in the step of attaching the microneedle device, the treatment site may include any one of a damaged blood vessel, an anastomosis site, and a graft.

The drug delivery device according to an embodiment of the present invention is a coil-type stent that surrounds a microneedle device for delivering a drug together with a treatment site, so that it can be mounted non-invasively, so that the procedure is easy, and the microneedle device can be stably installed. By pressing while fixing, it is possible to efficiently deliver the drug over the entire area of the microneedle device, and to minimize the side effects of the treatment site, thereby improving the treatment prognosis.

The drug delivery method according to another embodiment of the present invention can facilitate the treatment of the treatment site by using the drug delivery device having the above-described advantages.

1A is a plan view of a drug delivery device according to an embodiment of the present invention, and FIG. 1B is a perspective view illustrating coiled stents according to various embodiments of the present invention.
2A and 2B are plan views illustrating an application example of a drug delivery device according to an embodiment of the present invention.
Figure 3 is a view for explaining the mounting method of the coil-type stent according to an embodiment of the present invention.
4a to 4b are views showing coiled stents according to various embodiments of the present invention.
5A and 5B are perspective views illustrating a coiled stent according to various embodiments of the present invention.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

Examples of the present invention are provided to more completely explain the present invention to those of ordinary skill in the art, and the following examples may be modified in various other forms, and the scope of the present invention is as follows It is not limited to an Example. Rather, these examples are provided so that this disclosure will be more thorough and complete, and will fully convey the spirit of the invention to those skilled in the art.

In addition, in the drawings, the thickness or size of each layer is exaggerated for convenience and clarity of description, and the same reference numerals in the drawings refer to the same elements. As used herein, the term “and/or” includes any one and any combination of one or more of those listed items.

The terminology used herein is used to describe specific embodiments, not to limit the present invention. As used herein, the singular form may include the plural form unless the context clearly dictates otherwise. Also, as used herein, “comprise” and/or “comprising” refers to the presence of the recited shapes, numbers, steps, actions, members, elements, and/or groups of those specified. and does not exclude the presence or addition of one or more other shapes, numbers, movements, members, elements and/or groups.

Although the terms first, second, etc. are used herein to describe various members, parts, regions, and/or parts, these members, parts, regions, and/or parts should not be limited by these terms. is self-evident These terms are used only to distinguish one member, component, region or part from another region or part. Accordingly, a first member, component, region, or portion discussed below may refer to a second member, component, region or portion without departing from the teachings of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, embodiments of the present invention are described with reference to the drawings which schematically show ideal embodiments of the present invention. In the drawings, for example, the size and shape of the members may be exaggerated for convenience and clarity of description, and in actual implementation, variations of the illustrated shape may be expected. Accordingly, embodiments of the present invention should not be construed as limited to the specific shapes of the members or regions shown herein.

1A is a plan view of a drug delivery device 10 according to an embodiment of the present invention, and FIG. 1B is a perspective view illustrating coiled stents 200A to 200E according to various embodiments of the present invention.

Referring to FIG. 1A , in one embodiment, the drug delivery device 10 may include a microneedle device 100 and a coiled stent 200 . The microneedle device 100 is a microneedle device 100 that is attached to the treatment site (TR), for example, an external surface of a living tissue to perform a drug delivery function, and includes a body part and a microneedle formed on one side of the body part. may include The main body and the microneedle may be surrounded by the treatment site TR to have flexibility for drug delivery. The body portion may be in the form of a continuous film or may have a discontinuous film, for example, a texture such as a mesh. In addition, the body portion may have a cuff shape that surrounds the entire circumference of the treatment region TR or only a portion thereof. The embodiment of the present invention is not limited by the shape or structure of the body portion described above, and various known microneedles are included in the present invention. Any one of the body part and the microneedle, in particular the microneedle, may be a biodegradable material. The biodegradable material will be described later.

According to an embodiment, the treatment site TR may correspond to any one of a vascular site, anastomosis site, or graft that is damaged or requires treatment such as inflammation, as a non-limiting example. The blood vessel may be an artery, a vein, or a capillary, by way of non-limiting example. The anastomotic site includes blood vessels, and the digestive tract, for example. It may correspond to a region connecting any one of the esophagus, intestine, or stomach. However, this is a non-limiting example, and may include all anastomosis sites connecting various body organs. The graft may be, for example, a vein graft or an artificial vascular graft. The graft means an organ or tissue transplanted into a recipient, and an autograft that allows one's own tissue to be transferred to another location, an allograft transplanted from another individual within the allogeneic group, a xenograft transplanted from another animal of a different species, and an artificial blood vessel graft can be classified as However, this is not limited to the graft of the present invention, and may include various types of grafts that can be transplanted into organs or tissues in human or animal receptors.

According to an embodiment, the biodegradable material may include, for example, a biodegradable polymer material that can be dissolved by body fluids such as water or blood or body temperature. For example, chitosan, collagen, gelatin, hyaluronic acid (HA), alginic acid, pectin, carrageenan, chondroitin (sulfate), dextran (sulfate), polylysine (polylysine) , carboxymethyl titin, fibrin, agarose, pullulan, and at least any one of a bio-derived soluble material; polyvinylpyrrolidone (PVP); Polyethylene glycol (PEG), polyvinyl alcohol (PVA), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), hydroxypropyl methyl cellulose (HPMC), sodium carboxymethyl cellulose, polyalcohol, gum arabic, Alginate, cyclodextrin, dextrin, glucose, fructose, starch, trehalose, glucose, maltose, lactose, lactulose, fructose, turanose, melitose, melezitose, dextran, sorbitol, xylitol, palaty Nit, polylactic acid (polylactic acid), polyglycolic acid (polyglycolic acid), polyethylene oxide, polyacrylic acid, polyacrylamide, polymethacrylic acid, and a biomaterial of at least one of polymaleic acid, a derivative of the above-mentioned material, or these may be a mixture of The above-mentioned materials are non-limiting examples, and the present invention is not limited thereto, and all kinds of materials that are harmless to a living body and that can be naturally decomposed in a living body may be applied.

In addition, the microneedle device 100 may be made of a biocompatible polymer material. For example, the biocompatible polymer material may include silk fibroin having excellent biocompatibility with vascular tissues. In addition, the biocompatible material is cobalt (Co), titanium (Ti), stainless steel (Stainless steel), Teflon (Teflon), zinc (Zr), chromium (Cr), nickel (Ni), copper (Cu), Metal materials such as silver (Ag), gold (Au), aluminum (Al), Ni-Ti , molybdenum (Mo), tantalum (Ta), platinum (Pt), amal steel, human enamel, or these alloy of alumina (Al ₂ O ₃ ), zirconia (ZrO ₂ ), carbon, bioglass (Bioglass), hydroxyapatite (Hydroxyapatite, HA), calcium aluminate (Calcium aluminate), tricalcium phosphate (Tricalcium) phosphate), calcium sulfate (Calcium Sulfate), calcium phosphate (calcium phosphate), human dentin (Human dentin), a ceramic material such as cortical bone (Cortical bone) may be used.

In one embodiment, the biodegradable material and/or the biocompatible material itself constituting the microneedle may contain a drug to be delivered into a living tissue. For example, the drug may be provided to the microneedle itself in a mixed or dispersed form in the biodegradable material and/or the biocompatible material. In one embodiment, the drug may include a small molecule/polymer drug, a peptide, a protein, RNA, sRNAi, DNA or a cell. Accordingly, the microneedle is attached to the outer wall of the blood vessel, the microneedle pierces the tissue of the outer wall of the blood vessel to form a microchannel, and the aforementioned drug can be delivered through the microchannel. In the case of the drug, a drug that inhibits blood vessel proliferation, for example, polyphenol, epigallocatechin-3-gallate (EGCG), or a drug containing catechin and a substance It may include, but is not limited to, it may include all drugs corresponding to drugs for the treatment of vascular sites. In addition, since the microneedle device 100 of the present invention is not limited to the prevention and treatment of neointimal hyperproliferation, it is not only attached to the vascular site to treat the vascular site, but also to deliver drugs to the bloodstream to prevent other diseases. In the case of treatment or other organs, for example, the intestine is equipped with the microneedle device 100, it may contain various drugs capable of treating digestive diseases.

In another embodiment, a drug reservoir may be provided in the body portion of the microneedle device 100 so that the drug can be delivered through the microneedle. The drug reservoir may be attached to the upper surface of the body part, and may have an opening communicating with the upper surface of the main agent part for gauze or drug delivery. After attaching the microneedle device 100 to the treatment site TR, the drug may be injected into the drug reservoir, and the injected drug may be delivered to the treatment site TR through the microneedle.

In another embodiment, after coating a drug on the surface of the microneedle, the microneedle may be attached to the treatment site TR to deliver the drug. After attaching the microneedle device 100 coated with a drug on the surface of the microneedle to the treatment site TR, the coated drug may be delivered to the treatment site TR.

Referring back to FIG. 1A , the coiled stent 200 surrounds the microneedle device 100 surrounded by the treatment site TR and fixes the microneedle device 100 on the treatment site TR. The coiled stent 200 may have a length corresponding to the size of the microneedle device 100. In this case, the coiled stent 200 covers the entire upper surface of the microneedle device 100 by a certain pitch. While exposing the upper surface of the microneedle device 100, while completely surrounding the microneedle device 100, securing the fixing force to the microneedle device (100). Accordingly, according to an embodiment of the present invention, the drug injection by the microneedle device can be made stably.

Referring to Figure 1b, the coil-type stent 200A according to an embodiment extends in the longitudinal direction (D) of a straight line, has a predetermined constant diameter, is spirally extended at a predetermined pitch, and has a predetermined thickness. Includes dimensional wire rods. The diameter, pitch, and thickness of the wire rod of the coiled stent 200A may be appropriately designed according to characteristics such as disease, location, size, shape, and histological strength of the treatment site.

The coiled stent 200B according to another embodiment is similar to the above-described coiled stent 200A in that it extends in the longitudinal direction D of a straight line, but the diameter of the coiled stent 200B is in the longitudinal direction, that is, It varies along the x-axis direction. For example, it may have a shape in which the diameter of the coiled stent 200B is gradually increased. The coiled stents 200C and 200D according to another embodiment may have a shape in which the diameter of the coiled stents 200C, 200D gradually increases and then decreases again, or gradually decreases and then increases again along the longitudinal direction. Although not shown, a coil-type stent composed of a portion having a predetermined constant diameter and a portion having a variable diameter along the longitudinal direction (D) is also included in the embodiment of the present invention. According to another embodiment, the coiled stent 200E may be curved and extended with a predetermined curvature in the longitudinal direction. Although not shown, the diameter of the coiled stent 200E may be constant or variable as described above. Various coiled stents according to embodiments of the present invention may be appropriately designed according to the condition, size, shape, and histological strength characteristics of the treatment site to be applied. For example, when the tissue of the treatment site is weak, the thickness of the wire rod may be increased to increase the elastic modulus as much as possible, and the coil may be reduced in pitch. Conversely, if the tissue of the treatment site is strong, a thin wire that is easy to adapt to the diameter or curvature of the treatment site may be used, and the pitch of the helix may be increased if the thickness of the wire does not require a strong elastic modulus. In addition, for example, the pre-fired coil-type stent 200E may be applied to the curved blood vessel portion so as to be curved to a predetermined curvature in accordance with the curved blood vessel. In any case, the coil-type stents according to the embodiment of the present invention can be easily deformed according to the condition, size, shape, and histological strength characteristics of the treatment site to be applied, so that microscopically irrespective of the shape or characteristics of the treatment site. It is possible to secure a faithful fixation force to the treatment site of the needle device, and additional post-mortem such as applying pressure for drug injection or tissue insertion of the microneedle to the surface of the microneedle device exposed between the pitches of the coiled stent treatment is possible

The coiled stents 200A to 200E may have flexibility or elasticity depending on the material, pitch, and wire diameter of the coil. The elasticity of the coiled stents 200A to 200E is implemented in the longitudinal direction, that is, the x-axis direction, and the direction perpendicular to the extension direction, that is, the z-axis direction, that is, the radial direction. In the coiled stents 200A to 200E of the present invention, the elastic modulus in the longitudinal direction may be greater than the elastic modulus in the radial direction. The coiled stent 200 according to an embodiment of the present invention may be elastically tensile or compressively deformed more easily in the longitudinal direction than in the radial direction. This elastic deformation, the coil-type stent can accommodate the temporarily necessary deformation according to the environment of the treatment site, and after the treatment is finished, the coil-type stent 200 is restored, so that the required shape can be maintained. .

In addition, since the coil-type stents 200A to 200E are deformed in the radial direction, the microneedle device 100 surrounding the treatment site is secondarily surrounded by the microneedle device 100, and the microneedle device 100 is pressed and fixed on the treatment site. , so that drug injection by the microneedle device 100 can be made stably. In addition, since the coiled stents 200A to 200E can be deformed in the radial direction while the coiled stents 200A to 200E fix the microneedle device 100, the microneedle device 100 is biodegradable or When the microneedle device is contracted as the drug injection is slowly progressed, the microneedle device is also elastically restored while contracting, so the pressure of the microneedle device 100 on the treatment site and the fixing force of the microneedle device can be maintained as it is. . Accordingly, there is provided an advantage that the drug injection of the microneedle device can be faithfully injected into the treatment site for a required time. In addition, the compression and fixation force on the microneedle device is provided over the entire area of the microneedle device because the coiled stents 200A to 200E completely surround the microneedle device.

In one embodiment, when the treatment site is a blood vessel, the thickness t of the coiled stent 200 is in the range of 50.0 μm to 2.0 mm, and the diameter D1 of the coiled stent 200 is 500 μm to 30.0 mm can have a range. The ratio (D1/t) of the inner diameter (D1) of the coiled stent 200 to the thickness of the coiled stent 200 may be in the range of 10 to 600. When the ratio (D1/t) of the inner diameter of the coil-type stent 200 to the cross-sectional thickness of the coil-type stent 200 is 10 or less, the flexibility in the longitudinal direction of the blood vessel decreases, which may cause excessive stress to the vascular tissue, , over 600, it may not be possible to prevent excessive dilatation of blood vessels or may be damaged.

In one embodiment, when the treatment site is a blood vessel, the length (L) of the coiled stent 200 is in the range of 1 cm to 30 cm, and the number of pitches of the coiled stent 200 is in the range of 3 to 300, The spacing distance D2 between the pitches of the coiled stent 200 ranges from 0.10 mm to 10 mm.

In addition, the ratio (D2/t) of the spacing distance between the pitches of the coiled stent 200 (D2) and the thickness of the coiled stent 200 (D2/t) may have a range of 0.1 to 50. The elastic modulus in the longitudinal direction of the coiled stent 200 when the ratio (D2/t) of the spacing distance (D2) between the pitches of the coiled stent 200 and the thickness of the coiled stent 200 is 0.1 or less, and x It is difficult to satisfy the relationship between the first elastic modulus and the second elastic modulus in the axial direction and the z-axis direction, that is, the first elastic modulus is larger than the second elastic modulus, and when it is 50 or more, the first elastic modulus of the coiled stent 200 is Since it is difficult to secure a corresponding recovery rate, the coil-type stent 200 may not be restored to its original state again after it is stretched in the longitudinal direction.

According to one embodiment, the pitch interval of the coiled stent 200 may be less than or equal to the diameter of the treatment site. The pitch interval of the coiled stent 200 ranges from 10 to 50% of the treatment site, preferably from 10% to 20%.

According to one embodiment, the pitch interval of the coiled stent 200 may be less than or equal to the diameter of the treatment site. When the pitch interval is less than or equal to the diameter of the treatment site, the coil-type stent 200 is spread as much as the treatment site by elasticity, and may be inserted to surround the treatment site and/or the microneedle device 100 . According to another embodiment, the pitch interval of the coiled stent 200 may be greater than the diameter of the treatment site. If the pitch interval is larger than the diameter of the treatment site, the insertion of the coil-type stent 200 can be made more easily. Accordingly, through the coil-type stent 200 having various pitch intervals, it is possible to enable customized treatment for each patient.

According to another embodiment, as described above, to the exposed surface of the coiled stent 200, a drug may be additionally added. For example, when a drug reservoir that enables periodic drug injection into the microneedle device 100 is exposed between the pitches of the coiled stent 200, in supplying additional drugs, the coiled stent 200 Additional drugs can be injected without being affected. Accordingly, the drug delivery device 10 is advantageous in that drug injection or procedure can be additionally performed without releasing the coiled stent for treatment when continuous drug injection is required or when a large amount of drug injection is required. There is this.

The coil shape may be classified into various shapes according to the shape of the end of one side. The coil end shape of the coil-type stent 200 of the present invention may have a shape corresponding to any one of the abutting end, the open end, the beollim end, or the tangential tail end. In the case of the butt end, it may be ground or tapered. In the case of the open end, it may be ground. In the case of a flared end, it may be unground. However, this may include, but is not limited to, the case of processing the ends by various processing methods other than non-grinding, grinding, and taper. 1A and 1B show the shape of the end of the coil of the non-grinding bulging tip, but it is not limited thereto. It may include the shape of the coil end of various shapes.

The coiled stent 200 may be made of a biodegradable polymer or a polymer material for biomaterials. The biodegradable polymer or polymer material for biomaterials may be composed of various biodegradable polymers or polymer materials for biomaterials, as described above in the microneedle device 100, and is preferably flexible or elastic as described above. It may be composed of a material that can secure Since the coiled stent 200 is made of a biodegradable or biocompatible material, the microneedle device 100 may be melted or decomposed and melted or decomposed to disappear at the same time or after being absorbed or discharged into the tissue. Thereby, even if the coil-type stent 200 remains in the treatment site, for example, around the blood vessel, the inflammatory reaction of the tissue is minimized and the exchange of substances between the treatment site and the surrounding tissue is minimized from being disturbed.

2A and 2B are plan views illustrating an application example of a drug delivery device according to an embodiment of the present invention.

Referring to FIG. 2A , an intra-cardiac vascular tissue (VE) is exemplified as a surgical site. For the treatment of cardiovascular disease, the microneedle device 100 for drug delivery to the damaged vascular tissue (VE) is attached to the damaged vascular tissue (VE) site, and the microneedle device 100 is fixed to prevent separation from the vascular tissue. In order to prevent this, a coiled stent 200 may be disposed to surround the microneedle device 100 . The drug delivery device 10 may suppress neointimal hyperproliferation by, for example, delivering an antiproliferative drug through the microneedle device 100 .

The neointimal hyperplasia is a structural change of blood vessels in response to vascular damage. The neointimal hyperplasia is a condition in which smooth muscle cells of the vascular media move to the intima and proliferate, and together with the extracellular matrix accumulates in the intima, the thickness of the vascular intima is thickened to cause stenosis. The drug delivery device 10 can treat or prevent vascular restenosis by inhibiting the hyperinflammation of the endorenal membrane, and the microneedle device 100 is fixed by the coiled stent 200 to maximize the efficiency of drug delivery. can

However, FIG. 2A shows the drug delivery device 10 as a device for treating cardiovascular diseases, but this is not limited to heart diseases. It is clear that it can be used.

Referring to FIG. 2B , after performing a blood vessel bypass operation for treating a vascular disease, the drug delivery device 10 may be mounted on the vein graft. Drug delivery can be performed by mounting the microneedle device 100 in order to suppress neointimal hyperproliferation occurring in the vascular anastomosis site and vein graft, and the microneedle device 100 is stabilized by using the coiled stent 200 . can be fixed with

In addition, when a vein tissue is transplanted for arterial treatment, the vein tissue, which is the graft (GR), may expand due to an aneurysm with high blood pressure, thereby damaging the endothelial cells of the graft. When the drug delivery device according to an embodiment of the present invention is applied to the treatment site treated with weak venous tissue, the graft is reinforced by a coil-type stent capable of elastically strong compression in the radial direction, so that the surgical prognosis is good. can

3 is a view for explaining a mounting method of the coil-type stent 200 according to an embodiment of the present invention.

Referring to FIG. 3 , first, the step of attaching the microneedle device 100 to the treatment site may be performed. Regarding the treatment site and the microneedle device, reference may be made to the matters disclosed with reference to FIG. 1 .

Thereafter, it may include mounting the coil-type stent 200 surrounding the microneedle device 100 together with the treatment site. The coil-type stent 200 secures an appropriate fixing force and compression force to the microneedle device 100, and stably fixes it to the treatment site, thereby maximizing drug delivery efficiency.

For fixation of the coiled stent 200 , the microneedle device 100 may be initially inserted into the treatment site to which the microneedle device 100 is attached between the end of one side of the coiled stent 200 and the adjacent pitch of the first winding. The first winding means one round of the coil-type stent 200 . In order for the pitch (R1) portion of the first winding portion to be fitted to the treatment site for the first time, the pitch (R1) portion of the coil-type stent 200 may be widened by the diameter of the treatment site. Since the coiled stent 200 has flexibility or elasticity, deformation of the coiled stent 200 for the first fitting operation occurs easily, and there is an advantage of being restored again after mounting.

After the pitch (R1) of the first winding on one side of the coiled stent 200 is inserted into the treatment site, the coiled stent 200 is rotated in the spiral direction of the coil, for example, clockwise or counterclockwise. , the second winding pitch (R2) and the third winding pitch (R3) of the coiled stent 200 are sequentially inserted along the treatment site while surrounding the surface of the microneedle device 100 . If the rotation of the coil-type stent 200 is continued, the coil-type stent 200 is mounted on the treatment site while surrounding the entire treatment site, and the microneedle device surrounds the microneedle device as much as the length of the coiled stent 200 as a whole. Fix the device to the treatment site. the second winding defines a turn of the coil adjacent to the first winding, the third winding defines one turn of the coil adjacent to the second winding, and the N-th winding is adjacent to the N-1 th winding; One turn to the coil in the direction opposite to the N-2 winding can be defined. 3 illustrates a case where N is 7, this is a non-limiting example, and the coil-type stent 200 may include at least one winding according to the location and size of the treatment site.

As described above, the coil-type stent 200 may be mounted on the treatment site by simple rotation to firmly fix the microneedle device 100 . Accordingly, since the coil-type stent 200 according to the embodiment of the present invention is easily mounted by simply inserting and rotating the microneedle device 100 to the attached treatment site, the conventional method for fixing the microneedle device 100 Unlike the tube member, it does not require the additional steps of cutting the treatment site, for example, blood vessels, and re-suturing, so that non-invasive treatment can be achieved.

Figures 4a to 4c is a view showing the coil-type stents (200F ~ 200G) according to various embodiments of the present invention.

Referring to FIG. 4A , in one embodiment, the coiled stent 200F may include an anchor 210 . The anchor 210 may be provided at one end or both ends of the coiled stent 200 . The anchor 210 shown in FIG. 4A has a spike-like shape. The anchor 210F may be embedded in the surface of the treatment site or embedded in the upper surface of the microneedle device (see 100 of FIG. 1A ). When the anchor 210F is embedded in the surface of the treatment site, after the drug delivery device according to an embodiment of the present invention is mounted, the coiled stent 200F moves along the treatment site in the longitudinal direction of the coiled stent 200F can be prevented from doing Similarly, when the anchor 210F is embedded in the upper surface of the microneedle device 100, after the drug delivery device according to an embodiment of the present invention is mounted, the microneedle device 100 and the coiled stent 200F bonding can be strengthened.

Referring to Figure 4b, the anchor 210G may be provided on the inner peripheral surface of the wire constituting the coil-type stent (200G). By adjusting the number of anchors (210G), it is possible to adjust the fixing strength with the microneedle device (100). Accordingly, the number and length of the anchors 210G formed on the inner circumferential surface of the coiled stent 200G may be variously set to prevent movement of the microneedle device 100 . However, it is not limited to the anchors (200F to 200G) of the coiled stents (200F to 200G) shown in FIGS. 4A and 4B, and at least one of one end, both ends, and the inner peripheral surface of the coiled stent. An anchor may be provided.

The material of the anchor 210 may be the same as that of the coil-type stent. For example, when the anchor 210 is made of the aforementioned biodegradable or biocompatible material, it may disappear integrally with the microneedle device after a predetermined time elapses, thereby minimizing the inflammatory reaction caused by foreign substances. In Figures 4a and 4b, the anchor is exemplified by a cone-shaped structure, but is not limited thereto, and various shapes that can fix the microneedle device 100 and / or the treatment site, for example, a fishing hook and The same needle nose may be included.

Figures 5a and 5b is a perspective view showing a coil-type stent (200H ~ 200I) according to various embodiments of the present invention.

Referring to Figure 5a, the wire constituting the coil-type stent (200H) may have a square cross section. The coil-type stent 200H of the square cross-section has an effect that can suppress deformation in the longitudinal direction compared to the coil-type stent 200H of a circular cross-section having the same cross-sectional area, and the microneedle device 100 and the treatment site and There is an advantage in that the contact area of the can be expanded compared to the coil-type stent (200H) of a circular cross section.

Referring to FIG. 5B , the wire constituting the coiled stent 200I may have a rectangular cross-section having a long side in the longitudinal direction of the coiled stent 200I. The coil-type stent 200I of the rectangular cross-section may further suppress deformation in the longitudinal direction compared to the coil-type stent of the circular cross-section having the same cross-sectional area. In addition, there is an advantage in that the contact area between the microneedle device 100 and the treatment site can be maximized compared to the coil-type stent 200 having a circular cross section. However, the coil-type stent 200I of the rectangular cross-section may be easily deformed in the radial direction and may be plastically deformed beyond the elastic strength. It is necessary to reduce the pitch of the stent 200 or increase the length of the rectangular short side to sufficiently secure the thickness of the wire rod.

According to various embodiments of the present invention, by appropriately designing the cross-sectional shape of the wire constituting the coil-type stent 200, it is possible to fine-tune the deformation or compression force in the longitudinal direction, thereby responding to the structural features and conditions of the treatment site This has the advantage that it can be applied optimally. The cross-section of the wire rod constituting the coiled stent 200 according to various embodiments of the present invention is not limited to a circle, a square, and a rectangle, and may include various shapes such as an oval, a triangle, a trapezoid, a rhombus, or a star shape. it is clear that there is

It is common in the art to which the present invention pertains that the present invention described above is not limited to the above-described embodiments and the accompanying drawings, and that various substitutions, modifications, and changes are possible within the scope without departing from the technical spirit of the present invention. It will be clear to those who have knowledge.

10: drug delivery device
100: microneedle device
200, 200A, 200B, 200C, 200D, 200E, 200F, 200G, 200H, 200I: coiled stent
210F, 210G: overhang
R1, R2, … R7: 1st winding pitch, 2nd winding pitch, ... Volume 7 Pitch
TR: treatment area
VE: blood vessels
GR: graft

Claims (21)

a microneedle device attached to the treatment site to deliver drugs; and
Comprising a coil-type stent for fixing the microneedle device while surrounding the treatment site to which the microneedle device is attached,
The coiled stent has a first modulus of elasticity in a longitudinal direction of the coiled stent, the coiled stent has a second modulus of elasticity in a radial direction of the coiled stent, and the first modulus of elasticity of the coiled stent is the first 2 greater than the modulus of elasticity,
The coiled stent is composed of at least one of a biodegradable material and a biocompatible material that biodegrades or disappears later than the microneedle device,
The coiled stent further comprises an anchor disposed in at least one of at least one end of the inner circumferential surface of the stent and an area between both ends of the inner circumferential surface, wherein the anchor is configured to be embedded in the surface of the microneedle device, ,
The cross-sectional thickness (t) of the coiled stent is in the range of 50.0 μm to 2.0 mm, the inner diameter (D1) of the coiled stent is in the range of 500 μm to 30.0 mm, and the inner diameter (D1) of the coiled stent and the ratio (D1/t) of the cross-sectional thickness (t) to the drug delivery device having a range of 10 to 600. The method of claim 1,
The coil-type stent is inserted into the treatment site to which the microneedle device is attached between the pitch of the first winding portion adjacent to the end of the coil-type stent, rotates, and surrounds and fixes the microneedle device. The method of claim 1,
The treatment site is a drug delivery device comprising any one of a blood vessel injury site, an anastomosis site, and a graft. The method of claim 1,
The microneedle device is a drug delivery device comprising at least one of a biodegradable material and a biocompatible material. The method of claim 1,
The microneedle device may include a body portion; and
It includes a microneedle formed on one side of the body part,
The drug delivery device of any one of a continuous film form, a cuff form, and a mesh form of the body portion. delete The method of claim 1,
The coil-type stent is a drug delivery device corresponding to any one of the coil end shape butt end, open end, open end, or tangential tail end. delete delete The method of claim 1,
The pitch interval of the coil-type stent is less than or equal to the diameter of the treatment site. The method of claim 1,
The pitch interval of the coil-type stent is greater than the diameter of the treatment site drug delivery device. The method of claim 1,
A drug delivery device capable of further adding a drug to the exposed surface of the coiled stent. delete The method of claim 1,
The anchor is a drug delivery device comprising at least one of a spike and a needle nose. The method of claim 1,
The anchor is a drug delivery device consisting of at least one of a biodegradable material and a biocompatible material. The method of claim 1,
In the coil-type stent, the wire rod of the coil-type stent is a drug delivery device including a cross-sectional area of any one of a circle, a square, a rectangle, an oval, a triangle, a trapezoid, a rhombus, and a star. 2. The method of claim 1
The number of pitches of the coiled stent ranges from 3 to 300,
The spacing between the pitches of the coiled stent (D2) has a range of 0.1 mm to 10 mm,
The pitch interval of the coil-type stent is a drug delivery device having a range of 10% to 50% of the treatment area. delete delete delete delete

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