WO2020060159A1 - Thread embedding therapy rope and thread embedding therapy needle apparatus comprising same - Google Patents

Abstract

The present invention relates to a thread embedding therapy rope and a thread embedding therapy needle apparatus comprising same, and disclosed are a thread embedding therapy rope and a needle apparatus comprising same, the rope comprising a linear core, which comprises a biodegradable polymer, and a metal wire, which is arranged to spirally encompass the outer circumferential surface of the linear core, wherein the metal wire comprises a biodegradable metal formed with magnesium or zinc as a main component, so as to have no side effects on biological tissue when applied to the human body by means of thread embedding therapy, pulling force on the tissue can be strengthened, lifespan can be extended over that of a conventional embedded thread of a biodegradable polymer, the drug loading capability of the embedded thread itself can be increased so as to allow for usefulness as a drug carrier, and a drug can be delivered through a simple method.

Description

Rope for psoriasis therapy and needle device for psoriasis therapy including the same

The present invention relates to a rope for meditation therapy and a needle device including the same, and more particularly, to a rope for meditation therapy using a biodegradable metal and a needle device including the same.

THREAD EMBEDDING THERAPY is one of the blood-placement therapies, and it is a therapy that treats diseases by continuously stimulating the bloodstream by embedding foreign substances in the blood. Its purpose is to increase the therapeutic effect by extending the stimulation time for blood pressure as well as the physicochemical stimulation of the deposit. Animal tissues such as the dog's spleen, drugs, gangwon, and suicides were used, and metal tools and catguts are currently used. In Korea, chromic surgical threads are mainly used, and sutures based on polydioxanone (PDO), which has proven to be safe and has little tissue reaction and melts after a certain period of time, are widely used.

Looking at the two aspects of meditation therapy (요법) and the chamber, first, immersion was developed after a mouthful of `` Emperor's Diameter '', and many tools were developed depending on the intensity of the stimulus or the type of disease. In order to give continuous stimulation, the method of oil immersion was created, and the theoretical basis of oil immersion was provided in ≪Emperor's Inner Diameter Yeongchu and Jongsi≫.

The treatment using the chamber was recorded in the `` Taipei Hyeminbang '', compiled in around 982 by the Taepyeong Hyeminhwa Bureau of Songdae, and it was recorded that the treatment was performed on the blood level with a drug in the thread called psoriasis therapy or implantation therapy. In acupuncture medicine textbooks used in oriental medicine education, acupuncture is divided into acupuncture according to the stimulation site, acupuncture according to the stimulation method, and acupuncture according to a specific theory. It corresponds to the law (新 鍼 具 鍼刺 法).

As an indication of psoriasis therapy, it is a level that treats a variety of diseases such as acute illness beyond the border between chronic and ischemic conditions, and there are more than 200 types of diseases that can be treated. Its contents are internal medicine, surgery, gynecology, pediatrics, and dermatology. , Otolaryngology, musculoskeletal disorders and other fields.

In modern medicine, psoriasis therapy is widely used as a method for inserting a lifting wire such as a lifting wire to improve skin aging or wrinkles. The specific causes of skin aging, such as wrinkles and loss of elasticity, have not been clearly identified in long-term studies, but by inserting an implant under the skin, such as by inserting a lifting wire subcutaneously, a prominent direct effect similar to that of a surgical method can be obtained. Lifting wire not only has the mechanical effect of pulling the skin under the skin, but also promotes collagen production in the dermal layer as the cell tissue around the inserted lifting wire is healed and regenerated, thereby revitalizing the skin elasticity and wrinkles. have.

Recently, a method of using a biodegradable suture to decompose in vivo is applied after the suture inserted into the dermal layer fulfills its role.

As the material of the suture, polydioxanone (PDO) is the most commonly used, and recently, the use of poly-L-lactic acid (PLLA) material in terms of characteristics that do not decompose longer in the body and human-friendly properties Is increasing. On the other hand, polylactic acid (PLA), polyglycolic acid (PGA), polycarpolactone (PCL), glycolide-lactide copolymer (PGLA) and copolymers thereof are considered in addition to decomposition speed, mechanical strength and ductility. (Copolymer) etc. are biodegradable materials that can be used as sutures for psoriasis therapy. However, since these biodegradable polymer materials are basically weak in strength, there is a great risk of unwanted breakage during the procedure, and the biocompatibility is relatively low compared to some approved metal materials, causing pain and inflammation. Occasionally, a biorejection reaction of the back occurs.

As a technique for presenting a solution to some of these problems, Korean Patent Registration No. 10-1641299 discloses a metal coating thin film by depositing metal ions or metal particles on the surface of a biodegradable visible plume so that body fluid and visible plume are formed. Although it has been disclosed to prevent this direct contact, only gold, silver, and titanium, which are known to have high biocompatibility as a deposited metal component, are limited, and thus, a clear solution to decomposition of the metal component in the body is not proposed. In addition, since the structure is deposited on the polymer suture in the form of a thin film, a solution to the strength reduction of the polymer material, which is a major problem in the related art, has not been suggested. In addition, when the surface of the biocompatible visible plume is deposited with metal ions or metal particles, the visible plume does not substantially perform the function of the chamber.

On the other hand, the present inventors have studied the biocompatibility and maintenance of strength of biodegradable Mg-Ca-Zn-based alloy bone graft material (Cho SY, Chae SW, Choi KW, Seok HK, Kim YC, Jung JY, Yang SJ) , Kwon GJ, Kim JT, Assad M. 2012.Biocompatibility and strength retention of biodegradable Mg-Ca-Zn alloy bone implants.J Biomed Mater Res Part B 2012: 00B: 000-000). Specifically, the biocompatibility and strength retention of the Mg-Ca-Zn alloy bone screw were evaluated, and as a result, in the histopathological analysis using the rabbit transplantation model, the Mg-Ca-Zn alloy contained inflammatory cells in the tissue around the implant. It showed no or almost no results. In addition, hematology and serum biochemical tests have been demonstrated to be acceptable before and after transplantation, and have demonstrated that the release of metallic elements from implants does not have any significant effect on normal tissue levels. In this aspect, it has been confirmed that Mg-Ca-Zn-based alloys are excellent alternatives to orthopedic biodegradable polymers.

The present inventors have confirmed the excellent biocompatibility of the Mg-Ca-Zn-based alloy and tried to graft it to various fields, and as an example, tried to utilize it as a microcarrier. In this regard, the present inventors have previously applied for microcarriers containing Mg or Zn-based metals such as Mg or Zn alone or Mg-Zn-Ca-based alloys (Korean Patent Publication No. 2017-0115449). The microcarrier was commissioned by the P & C Skin Research Center to perform a human body application test. Specifically, it measured the eye wrinkles, skin elasticity, dermal density and skin thickness, as well as the stability to evaluate its efficacy. have.

The present invention uses biodegradable metals including Mg or Zn metals or alloys thereof whose biocompatibility has been confirmed from the research of the present inventors, and has no side effects on biological tissues when applied to the human body by psoriasis therapy. It is possible to enhance the traction power for, and can extend its lifespan compared to conventional biodegradable polymers, and improves the drug carrying capacity of the psoriasis, which is useful as a drug carrier, and can provide drugs through a simple method It is intended to provide a therapeutic rope.

The present invention also seeks to provide a needle device for meditation therapy including such a meditation rope.

The present invention comprises a linear core comprising a biodegradable polymer; And

It includes a metal wire wound in a spiral on the outer peripheral surface of the linear core,

The metal wire provides a rope for psoriasis therapy comprising magnesium or zinc alone or a mixture thereof, and at least one biodegradable metal selected from magnesium or zinc alloys thereof.

More specifically, in the present invention, the biodegradable metal may be represented by the following Chemical Formula 1.

[Formula 1]

Mg _a Zn _b X _c

In Formula 1, a, b and c are the weight percentages of each component, a + b + c = 100% by weight, and a or b in the range of 0≤a≤100, 0≤b≤100, 0≤c≤30 Is the largest, X is a metal other than magnesium or zinc.

In the rope for psoriasis therapy according to a preferred embodiment, the metal wire may have a protrusion including at least one irregular or regularly arranged plurality of protrusions.

In the rope for psoriasis therapy according to a preferred embodiment, the metal wire may have a protrusion having a triangular protrusion continuously arranged on one surface.

Rope for meditation therapy according to a preferred embodiment may be in the form of thorns.

In the rope for psoriasis therapy according to a preferred embodiment, the metal wire is a, b and c in the formula (1) as a weight percentage of each component, a + b + c = 100% by weight, i) 90≤a ≤100, 0≤b≤10, 0≤c≤10 or ii) 0≤a≤10, 90≤b≤100, 0≤c≤10, X is Ca, Fe, Mn, Si, Na, Zr, It may be one containing at least one biodegradable metal selected from the group consisting of Ce, Ag and P.

In one preferred embodiment, the metal wire may be Mg having a purity of 95% or more.

In terms of sustained release and sustaining power as a support, the metal wire may be Zn having a purity of 95% or more.

In one preferred embodiment, the linear core is at least one selected from polydioxanone (PDO), polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), and copolymers thereof. It may be to include a biodegradable polymer of.

In another embodiment of the present invention provides a needle device for psoriasis therapy including a rope for psoriasis therapy according to the above embodiments.

The rope for meditation therapy of the present invention has a form in which a metal wire containing a biodegradable metal or alloy is spirally wrapped around a linear core containing a biodegradable polymer, so that the metal has a metal in applying biodegradable metal or alloy to meditation therapy. By effectively lowering the stiffness and having flexible mechanical properties, it is possible to minimize the foreign feeling of the metal, improve the traction force to the tissue of the rope, and be made of polymer by the mechanism in the body of a specific biodegradable metal or alloy. By reducing the amount of hydrolysis by reducing the contact area between the linear core and the tissue, the life of the rope can be extended, and the drug delivery system as the drug is efficiently carried in the space formed between the winding of the metal wire as well as the linear core. Useful as a simple method called meditation therapy It can provide a method of administration that can deliver drugs. Furthermore, it is possible to obtain an additional effect capable of expressing a swelling effect, aka filler effect, by a mechanism in the body of a biodegradable metal or alloy. On the other hand, the biodegradable polymer has a problem that the strength decreases due to the reduction of the cross-sectional area and the concentration of stress due to the physical processing, but in the present invention, the mechanical properties are not deteriorated because the linear core containing the biodegradable polymer itself is not physically processed. There are advantages.

 Figure 1 shows an embodiment of the rope for psoriasis therapy of the present invention, an example of a structure in which a metal wire having a smooth surface is wound spirally on the outer circumferential surface of a linear core.

Figure 2 shows an embodiment of the rope for the meditation therapy of the present invention, an example of a structure in which a metal wire having a projection on one surface of the linear core is wrapped in a spiral, and Figure 3 is a rope of the rope according to Figure 2 It is a longitudinal section.

Figure 4 shows an example of a needle device interpolated rope for psoriasis therapy of the present invention.

Figure 5 is a graph of the results of measuring the decomposition rate according to the sample for each component of the biodegradable metal in the biodegradable metal contained in the metal wire constituting the rope for psoriasis therapy of the present invention.

Figure 6 is a photograph showing the process of inserting and transplanting the rope for psoriasis therapy of the present invention in the transdermal rat.

7 to 8 is an image observed by Micro-CT after inserting the rope for psoriasis therapy of the present invention into the transdermal rat, FIG. 7 is immediately after insertion, and FIG. 8 is an image 1 week after insertion.

Hereinafter, the present invention will be described in more detail with reference to the drawings.

The present inventors have studied the biocompatibility and efficacy effect of each application in relation to an alloy containing magnesium or zinc metal alone or as described above, and have presented the results in the form of a thesis or patent application.

The present invention was obtained as a result of continuously conducting research based on such a study, and the present invention was devised as a result of various efforts to apply the biodegradable metal as a drug delivery agent by psoriasis therapy.

The grafting of the biodegradable metal according to the present invention to the meditation therapy includes a linear core comprising a biodegradable polymer; And a metal wire spirally wound on the outer circumferential surface of the linear core, wherein the metal wire is at least one biodegradable metal selected from magnesium or zinc alone or a mixture thereof, and alloys containing magnesium or zinc as a main component thereof. It is provided as a rope for psoriasis therapy that includes.

In the rope for psoriasis therapy according to the present invention, the metal wire is effective in all biodegradable metals, particularly biodegradable metals including magnesium or zinc, but is not limited thereto, and for example, biodegradable metals represented by the following Chemical Formula 1 It may include.

[Formula 1]

Mg _a Zn _b X _c

In Formula 1, a, b and c are the weight percentages of each component, a + b + c = 100% by weight, and a or b in the range of 0≤a≤100, 0≤b≤100, 0≤c≤30 Is the largest, and X may be a metal other than magnesium or zinc. Here, X may be a metal known to not inhibit the biodegradability of the alloy, and even if the biodegradability is lean or not, it may be a metal that does not cause toxicity when it is easily discharged to the body or remains in the human body.

It is preferable that the biodegradable metal contains the most magnesium or zinc. Accordingly, in Formula 1, a, b, and c are weight% of each component, and a + b + c = 100% by weight, i) 90≤a≤100, 0≤b≤10 and 0≤c≤10 or ii) 0≤a≤10, 90≤b≤100 and 0≤c≤10, X is one or more selected from the group consisting of Ca, Fe, Mn, Si, Na, Zr, Ce, Ag and P It may be desirable.

The biodegradable metal according to the present invention is a metal having the property of absorbing and decomposing in tissue and releasing metal ions and decomposition products into the body when applied as a meditation therapy, magnesium (Mg), calcium (Ca), zinc (Zn) Etc. is an alkaline metal-based biodegradable metal, and has a mechanism for releasing hydrogen gas by reacting with water, as shown in Reaction Schemes 1 to 3 below.

[Scheme 1]

Mg + 2H ₂ O → Mg (OH) ₂ + H ₂ (gas)

[Scheme 2]

Ca + 2H ₂ O → Ca (OH) ₂ + H ₂ (gas)

[Scheme 3]

Zn + 2H ₂ O → Zn (OH) ₂ + H ₂ (gas)

In the present invention, the biodegradable metal may be preferably made of magnesium (Mg) or zinc (Zn) as a single material, and is excellent in biocompatibility and does not exhibit toxicity in normal cells or tissues. May be a biodegradable metal that is a magnesium-only material, but may be preferably zinc, which has a slower decomposition rate than magnesium, when considering a function as a long-term support or continuous and long-term drug release. Here, the term magnesium will be understood as magnesium having a purity of 95% or more, and zinc will also be understood as zinc having a purity of 95% or more.

In the rope for psoriasis therapy, the biodegradable metal material may have a slightly higher decomposition rate for use alone as a long-term support. This problem can be solved by using a biodegradable polymer as a core wire to extend mutual life.

On the other hand, the biodegradable metal represented by Chemical Formula 1 can control its decomposition rate by including an intermetallic compound having a different potential. For example, two or more metal phases generate a galvanic circuit to accelerate the decomposition rate. You can.

Specifically, the biodegradable metal may include a biodegradable metal including a Mg ₂ Ca phase, a MgZn phase, or a Ca ₂ Mg ₆ Zn ₃ phase.

As another method for controlling the decomposition rate, a biodegradable metal surface represented by Chemical Formula 1 may be coated with PEO (Plasma electrolytic oxidation) coating, polymer coating, or another type of second metal. At this time, the second metal may include sodium, magnesium, potassium, iron, nickel, zinc, gallium, selenium, strontium, zirconium, molybdenum, niobium, tantalum, titanium, silicon, silver, gold, manganese, calcium, and the like. It is not limited. At this time, when the iron (Fe) is included, in particular, chromium (Cr) and nickel (Ni) having a stainless function should be controlled to less than 1% by mass to maintain corrosion rate and biocompatibility.

The biodegradable metal of the present invention itself has antibacterial activity against acne-causing bacteria. The present inventors prepared a biodegradable metal composed of magnesium or zinc as a sole material and a biodegradable metal obtained by mixing different metals such as calcium with the metal in a thin plate form, and evaluated their antibacterial activity against acne-causing bacteria. As a result, it was confirmed that the biodegradable metal produced by using magnesium, calcium, or zinc as a sole material or an alloy in which a different kind of metal is mixed in a specific range has antibacterial activity itself, and thus alleviates acne including it. And a cosmetic composition for prevention has been previously filed (Korean Patent Application No. 10-2018-0078402).

According to these facts, in the case of the rope for psoriasis therapy of the present invention, antibacterial activity against propionibacterium acnes , which is an acne-causing bacterium, is also expressed during the procedure according to psoriasis therapy to prevent acne or to relieve acne caused. You can expect to be able to get

On the other hand, the linear core of the rope for meditation therapy of the present invention includes a biodegradable polymer, and such a biodegradable polymer can use various biodegradable polymers known to be applied or applied to conventional meditation therapy or suture. . Specific examples include polydioxanone (PDO), polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), and copolymers thereof, and the like. .

1 shows an example of the rope for meditation therapy of the present invention, the rope for meditation therapy 100 is a metal wire containing the biodegradable metal or alloy on the outer circumferential surface of the linear core 10 containing the biodegradable polymer 20 is arranged in a spirally wrapped form.

As such, one of the reasons why the metal wire 20 is arranged to be spirally wrapped around the linear core 10 may have a purpose of reducing the stiffness of the biodegradable metal or alloy. If only the biodegradable metal or alloy itself is applied in the form of wire as a rope for meditation therapy, biosafety can be secured, but the foreign body feeling may be increased. However, as in the present invention, when the metal wire is spirally wrapped around the biodegradable polymer linear core, the metal may have more flexible mechanical properties, thereby minimizing foreign body sensation.

Another reason is the side of the drug carrier, in addition to the function as a conventional chamber of the linear core including the biodegradable polymer, that is, the function as the drug carrier, the biodegradable metal is naturally formed while spirally surrounding the linear core. It can be expected that the drug carrying efficiency can be improved spatially through the space.

For example, a drug such as hyaluronic acid must be applied in the form of a liquid in order to be supported on a linear core containing a polymer. In the case of hyaluronic acid, the water solubility is extremely low, so the amount of the drug carried on the linear core must be extremely limited. none. On the other hand, in the case of the rope for psoriasis therapy of the present invention, as the drug can be carried through a microscopic space, it is possible to increase the actual carrying amount even if an aqueous hyaluronic acid solution is used, and a drug having low water solubility such as hyaluronic acid With respect to, it can be supported by powder or granule itself, not aqueous solution. Of course, it is of course possible to obtain an effect of substantially increasing the amount of drug carried as necessary.

In addition, from the side of improving the traction force to the tissue of the rope for psoriasis therapy, a spirally wrapped metal wire may be preferable because it can provide irregularities on the surface of the rope.

In one preferred embodiment of the present invention, the metal wire is preferably in terms of a side capable of stably securing a microscopic space for improving the drug carrying efficiency and a more firmly improving traction force on the tissue. It may have a protrusion including at least one irregular or regularly arranged multiple protrusions.

In the above and below description, the term "irregular or regularly arranged plural protrusions" means that when the sizes of the protrusions are the same or different, or when the protrusions are arranged to be continuous or not continuous, the shapes of the protrusions are the same or different. It will be understood as terms including both cases and combinations thereof.

An example of a rope for psoriasis therapy according to a preferred embodiment is shown in FIGS. 2 to 3, referring to this, the metal wire 20a has a protrusion 2 having a triangular protrusion continuously arranged on one surface. It may have.

When the metal wire 20a having such a shape is spirally wound on the linear core 10a, the rope 100a for psoriasis therapy has a longitudinal cross-section (shown in FIG. 3), and accordingly The size or shape of the naturally occurring microscopic space (S) has a shape that can stably carry the drug, and also, as a visible shape, it can strengthen the traction force on the tissue.

The rope for psoriasis therapy according to the present invention shown in FIGS. 1 to 3 is a reference to the technical idea of the present invention, and the present invention is not limited to this.

The rope for psoriasis therapy according to the present invention can reduce the contact area between the biodegradable polymer linear core and the tissue by having a metal wire including a biodegradable metal or alloy in a spiral wrap around the biodegradable polymer linear core. Moreover, considering the reaction mechanisms of the reaction formulas 1 to 3 in the biodegradable metals or alloys, ultimately the rope is reduced by reducing the contact area between the biodegradable polymer linear core and the tissues due to generation of hydrogen gas or other oxides. Can increase the remaining life in the tissue.

Accordingly, the rope of the present invention can not only function as a drug delivery system useful in various diseases requiring long-term drug administration, but also may be advantageous in terms of the effectiveness of stool therapy, which functions as a support in tissues.

According to the meditation therapy, it is possible to thicken and strengthen the weakened muscles by inducing the incorporation of indigenous substances in the body around the rope of the present invention, and also, the rope is recognized as a foreign body in our body, and the continuous biochemical stimulation of the place where the procedure has been performed and It promotes tissue recovery and long-lasting physical and chemical stimulation enables changes in body structure and function, which can be effective in treating chronic chronic diseases. These psoriasis treatments are applied to the lumbar disc, neck disc, facial paralysis sequelae, facial beauty procedures, knee arthritis, fissure shoulders, facial asymmetry or partial obesity, and serve as a support for muscles and ligaments and improve blood circulation, thereby improving pain circulation and cosmetic surgery. Effect can be expressed.

Moreover, in the case of the rope of the present invention, it can function as an effective drug delivery agent for the treatment of chronic diseases by maximizing the drug-carrying efficiency and extending the life of the rope when used for such various palliative therapies, so that its efficacy can be maintained for a long time with one administration. By doing so, it is possible to reduce side effects caused by frequent and long-term drug administration of chronic patients, and it may also be desirable in terms of enabling topical drug administration in a simple manner.

In addition, by being able to maximize the traction in the tissue, it can fulfill the role of a muscle and ligament crutch faithfully, and it can be useful as a lifting wire that can effectively improve when the face is struck and has many wrinkles.

On the other hand, considering the reaction mechanism of the biodegradable metals or alloys as shown in the above Reaction Schemes 1 to 3, hydrogen gas is generated in the tissue to impart a swelling effect. This can be expected that the rope according to the present invention will be useful as a solid filler through meditation therapy. Regarding the filler, a liquid filler such as hyaluronic acid is commonly used in recent years, and a number of cases of rejection reaction to a large amount of injected hyaluronic acid have been confirmed, and when it is necessary to remove the injection filler due to a biorejection reaction, hyaluronic acid is used. Although the removal procedure is performed using a degrading enzyme such as Nase, there is a problem that it is difficult to remove completely. Accordingly, in accordance with the demand for ease of removal, there are a growing number of doctors who want a solid filler that can be easily removed. In this case, filler injection, ease of insertion, ease of product molding, and biocompatibility are required as main characteristics, and in addition, tissue There is a growing need for solid fillers in which advantageous effects for cell activation can be added. The rope according to the invention can be useful as a solid filler that can meet these needs.

On the other hand, in the rope for meditation therapy according to the present invention, the thickness of the linear core, etc. is not limited as long as it is generally accepted as the size of the biodegradable polymer filament for meditation therapy, and includes the biodegradable metal introduced according to the present invention. In the case of a metal wire, it may be desirable to have a filament thickness equivalent to that of a biodegradable polymer filament in consideration of a feeling of foreign matter in a tissue and ease of winding in a spiral. In the conventional range, the linear core and the metal wire may be 18 gauge to 30 gauge, but are not limited thereto.

When the rope of the present invention having various effects as described above is used as a meditation therapy, it may be provided in the form of various needle devices according to conventional meditation therapy. Psoriasis therapy is a therapy that continuously treats a disease by putting the above-mentioned rope on various designed needles and injecting them into a desired area, and leaving only the rope in the stool, which can be combined with various types of needles.

4 shows an example of the needle mechanism 200 interpolating the rope 100a of the present invention, but is not limited thereto.

In the case of interpolating the rope 100a in FIG. 4, it is preferable to interpolate the part including the metal wires into the needle and prevent the linear core 10a from being exposed only in order to prevent resistance or scratch when inserted into the tissue. However, in the drawings, it should be understood that a portion of the rope 100a of the present invention is exposed to show that it is interpolated into a needle.

Hereinafter, the present invention will be described in detail based on Examples, and it goes without saying that the present invention is not limited by these Examples.

<Reference example>

The stability evaluation of the skin to the biodegradable metal contained in the metal wire constituting the rope of the present invention has been already identified from research papers or inventor patent applications by the present inventors as described in the background art.

Thus, the biodegradable metal wire of the present invention can be invaded without irritation to the skin without exhibiting toxicity in normal cells or tissues.

In the following examples, examples of decomposition characteristics according to the metal element composition of the biodegradable metal contained in the metal wire constituting the rope of the present invention are shown, which are biodegradable metals in a linear core known as a group biodegradable polymer. It is an example to show that in case of winding, it is possible to control various decomposition rates in vivo.

A metal sheet (casting in a high-frequency melting furnace and then extruding at a rate of 0.1 mm / s was performed at a speed of 0.1 mm / s) with the composition (% by weight) of Table 1 below to prepare a metal sheet.

Sample	Mg	Ca	Zn
One	99.99 *	-	-
2	98.35	0.05	1.60
3	98.95	0.05	1.00
4	98.9	0.10	1.00
5	98.85	0.15	1.00
6	96.9	0.10	3.00
7	96.85	0.15	3.00
8	0.00	0.00	99.99 *
9	10.00	0.00	90.00

* Pure metal containing inevitable impurities generated during manufacturing

After immersing the metal sheets prepared in Samples 2 to 7 in an Eudiometer containing a biomimetic solution having the composition of Table 2, the decomposition rate was evaluated by the amount of hydrogen generated according to the immersion time, and the results are shown in FIG. 5. Shown.

ingredient	Molar concentration [mM / L]	Mass [g]
CaCl 2 · 2H 2 O	1.26	0.185
KCl	5.37	0.400
KH 2 PO 4	0.44	0.060
MgSO 4 · H 2 O	0.81	0.200
NaCl	136.89	8.000
Na 2 HPO 4 2H 2 O	0.34	0.060
NaHCO 3	4.17	0.350
D-Glucose	5.55	1.000

In Fig. As shown in 7, Mg ₂ Ca phase does not produce a sample of 2 to 5 (Example 2 to 5) Samples that the metal sheet is showed and, Mg ₂ Ca phase generate a hydrogen gas generation amount of the stable decomposition. 6 and 7 The amount of hydrogen gas generated in the metal sheet was significantly higher than the other examples, and thus it was confirmed that the decomposition rate was increased. Through this, it was confirmed that the decomposition rate can be adjusted through the composition control of the biodegradable metal.

<Example 1>

The needle apparatus for psoriasis therapy as shown in FIG. 4 was manufactured with the standards shown in Table 3 below.

Metal wire form	Linear core components	Needle (W Type)		Linear core (suture)
		gauge	Length (mm)	USP standard	Overall length (mm)	Of the entire length, the length of the part where the metal wire is wrapped (mm)
1 or 2 metal wire form (for example, metal wire made of magnesium having 95% purity; Mg-Zn-Ca alloy wire; or Mg-Zn-Ca-Mn alloy wire)	Polydioxanone. Polycaprolactone or polyglycolide-lactide copolymer	18G	38	0	100	30
			50		110	40
			60		120	50
			100		170	90
		19G	38	2-0	100	30
			50		110	40
			60		120	50
			100		170	90
		21G	38	3-0	100	30
			50		110	40
			60		120	50

According to the standard shown in Table 3, it can be seen that the length of the portion wrapped with the metal wire is adjusted among the entire length of the linear core in consideration of the length of the needle. That is, it can be confirmed that the length of the portion wrapped with the metal wire does not exceed the length of the needle so that the portion wrapped with the metal wire is completely included in the needle. This is because it is desirable to include a metal wire to the inside of the needle and interpolate with only the linear core portion exposed as a side for preventing scratch.

In the above specification, the shape of the metal wire has been described, and the metal wire is applied in the form of spirally winding a linear core. In practice, the width, thickness and length of the metal wire are the size of the suture and the gauge of the needle and Of course, it can be adjusted in various ways considering the length.

<Experimental Example>

Regarding that the rope for psoriasis therapy of the present invention generates hydrogen gas in tissues, and it is possible to extend the life of the rope by reducing the contact area between the linear core made of polymer and tissue due to the generation of the hydrogen gas. In order to confirm, rats were inserted into the transdermal layer of the rope for psoriasis therapy and experiments were observed to observe them through Micro-CT.

Specifically, polydioxanone is used as a linear core, and the wire for meditation therapy is wrapped in a metal wire made of magnesium having a purity of 95% (0.07 mm thick and 0.7 mm wide) in the form shown in FIG. 1 (full length) Prepared by using a needle device for psoriasis therapy as shown in FIG. 4 by preparing a length of 50 mm of the metal wire wrapped in 70 mm).

This was inserted into the transdermal layer of the rat in the order shown in FIG. 6.

As a result of observing with the Micro-CT (resolution 80㎛, FOV 40mm) for the rats that completed such a procedure, it can be confirmed from the results of FIGS. 7 to 8 that air pockets are irregularly generated immediately after insertion.

Here, FIG. 7 is a Micro-CT image immediately after inserting the rope for psoriasis therapy, and FIG. 8 is a Micro-CT image 1 week after insertion.

The arrows indicated in FIGS. 7 to 8 are portions in which the linear core is wrapped with a metal wire, and only the micro-CT can not confirm the linear core.

In the arrows indicated in FIGS. 7 to 8, black spots exist around the rope, which corresponds to an air pocket caused by hydrogen gas generation as a magnesium decomposition product.

These results also show that an additional effect capable of expressing a swelling effect, aka filler effect, can be obtained by a mechanism in the body of a biodegradable metal or alloy.

The rope for psoriasis therapy according to the present invention and the needle device for psoriasis therapy comprising the rope for psoriasis therapy has no side effects on biological tissues when applied to the human body as psoriasis therapy, and can enhance traction on tissues, and conventional biodegradability It can extend its lifespan compared to polymer embedding, and it is useful as a drug delivery agent by improving the drug carrying capacity of the embedding itself, and it can be useful as a device capable of delivering the drug through a simple method.

Claims (10)

1. A linear core comprising a biodegradable polymer; And

   It includes a metal wire wound in a spiral on the outer peripheral surface of the linear core,

   The metal wire is magnesium or zinc alone or a mixture thereof, and magnesium or zinc as the main component, at least one selected from biodegradable metals selected from the metal ropes for psoriasis therapy.
2. According to claim 1, The biodegradable metal is a rope for psoriasis therapy represented by the following formula (1).

   [Formula 1]

   Mg _a Zn _b X _c

   In Formula 1, a, b and c are the weight percentages of each component, a + b + c = 100% by weight, and a or b in the range of 0≤a≤100, 0≤b≤100, 0≤c≤30 Is the largest, X is a metal other than magnesium or zinc.
3. The method of claim 1, wherein the metal wire is a rope for psoriasis therapy, characterized in that it has a protrusion including a plurality of protrusions arranged irregularly or regularly on at least one surface.
4. The method of claim 1, wherein the metal wire is a rope for psoriasis therapy, characterized in that it has a protruding portion in which a protrusion having a triangular cross section is continuously arranged on one surface.
5. The method of claim 4, wherein the rope for psoriasis therapy is characterized in that it has the form of psoriasis therapy.
6. According to claim 2, wherein the metal wire is a, b and c in the formula (1) as a weight% of each component, a + b + c = 100% by weight, i) 90≤a≤100, 0≤b≤ 10, 0≤c≤10 or ii) 0≤a≤10, 90≤b≤100, 0≤c≤10, X is composed of Ca, Fe, Mn, Si, Na, Zr, Ce, Ag and P Rope for psoriasis therapy, characterized in that it comprises at least one biodegradable metal selected from the group.
7. The method of claim 1, wherein the metal wire is a rope for psoriasis therapy, characterized in that the purity is Mg of 95% or more.
8. The method of claim 1, wherein the metal wire is a rope for psoriasis therapy, characterized in that Zn with a purity of 95% or more.
9. The method of claim 1, wherein the linear core is characterized in that it comprises at least one biodegradable polymer selected from polydioxanone, polylactic acid, poly-L-lactic acid, polyglycolic acid, polycaprolactone, and copolymers thereof. Rope for psoriasis therapy.
10. A needle apparatus for psoriasis therapy comprising the rope for psoriasis therapy according to any one of claims 1 to 9.

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