WO2006088288A1

WO2006088288A1 - Medical needles having antibacterial and painless function

Info

Publication number: WO2006088288A1
Application number: PCT/KR2006/000044
Authority: WO
Inventors: Won-Dong Yang
Original assignee: Won-Dong Yang
Priority date: 2005-02-19
Filing date: 2006-01-05
Publication date: 2006-08-24
Also published as: JP2008529711A; CN101119698A

Abstract

The present invention relates to medical needles having antibacterial and painless functions, and more particularly, to medical needles having excellent antibacterial activity, and at the same time, a function of relieving the pain of patients, in which silver (Ag) particles having a diameter of nanometers are contained in the needle body or coated on the needle surface. The inventive medical needles include a needle for injection, a needle for operation, and a needle for acupuncture.

Description

MEDICAL NEEDLES HAVING ANTIBACTERIAL AND

PAINLESS FUNCTION

Technical Field

[1] The present invention relates to medical needles having antibacterial and painless functions, and more particularly, to medical needles having excellent antibacterial activity, and at the same time, a function of relieving the pain of patients, in which silver (Ag) particles having a diameter of nanometers are contained in the needle body or coated on the needle surface. The inventive medical needles include a needle for injection, a needle for operation, and a needle for acupuncture.

[2]

Background Art

[3] Generally, medical needles, such as injection needles, surgical needles or acupuncture needles, are applied to patients by the hand of men. However, it is known that bacteria of generally 200,000-300,000 ea/cm or more may exist on the men's hand. Furthermore, if hand washing or disinfection is insufficient, the number of bacteria detected can be further increased, and in a severe case, that mites or molds can also be found on the hand. Thus, there is still a possibility that patients may be infected with bacteria in a procedure when an operator handles medical needles.

[4] Recently, nano-silver technology of making particles having an ultrafine size of nanometers has been used in various industrial fields. As known well, silver nano- particles can be processed in the form of sol solution or powder, are harmless to the human body and have antibacterial, deodorizing, UV-shielding and electromagnetic shielding functions, etc.

[5] In antibacterial mechanisms, silver nano-particles dissolve the cell membrane of noxious germs and affect enzymes in the cells so as to suppress the metabolic functions of nutrients, i.e., the introduction and release of nutrients, ultimately killing the noxious germs. It is reported that the smaller the size of silver nano-nano particles, the better the bactericidal and antibacterial activities thereof, and the silver nano-particles show powerful antibacterial and bactericidal activities against E. coli, Staphylococcus aureus, Salmonella sp., Vibrio sp., Shigella, Pneumonia, Salmonella typhi, and me- thicillin-resistant Staphylococcus aureus.

[6]

Disclosure of Invention Technical Solution

[7] It is an object of the present invention to provide medical needles having an- tibacterial and painless functions, which can present the risk of bacterial infection resulting from the hand of an operator, and at the same time, relieve the pain of a patient, in which silver nano-particles are contained in the needle body or coated on the needle surface.

[8]

Brief Description of the Drawings

[9] FlG. 1 shows various types of acupuncture needles.

[10] FlG. 2 is a perspective view showing a conventional syringe.

[11] FlG. 3 is an electron microscopic photograph taken at 60,00OX magnification for the cross-section of the medical needle manufactured according to the present invention.

[12] FlG. 4 is an electron microscopic photograph taken at 80,00OX magnification for the side of a medical needle according to the present invention.

[13] FlG. 5 is a schematic diagram showing an electro-acupuncture process for an obesity patient.

[14]

Best Mode for Carrying Out the Invention

[15] In one embodiment, the present invention provides a medical needle selected from the group consisting of a needle for injection, a needle for operation and a needle for acupuncture, wherein silver nano-particles having a diameter of 0.1-300 nm are coated on the surface of the needle to a thickness of 0.01-50 D.

[16] In another embodiment, the present invention provides a medical needle selected from the group consisting of a needle for injection, a needle for operation and a needle for acupuncture, wherein silver nano-particles having a diameter of 0.1-300 nm are contained in the needle body in an amount of 0.01-20% by weight based on the weight of the needle.

[17]

[18] Hereinafter, the present invention will be described in more detail.

[19] The present invention provides a medical needle selected from the group consisting of a needle for injection, a needle for operation and a needle for acupuncture, wherein silver nano-particles having a diameter of 0.1-300 nm are coated on the surface of the needle to a thickness of 0.01-50 D. If the coating thickness of the silver nano-particles is less than 0.01 D, the coated silver nano-particles will show little or no effect, and if it is more than 50 D, an increase in cost will be caused and there will be no effects caused by an increase in the coating thickness.

[20] The silver nano-particles used in the present invention have a particle diameter of

0.1-300 nm. This is because a particle size of less than 0.1 nm cannot yet be achieved in the current technology, and a particle size of more than 300 nm shows a reduction in antibacterial effects.

[21] In another embodiment, the present invention provides a medical needle wherein silver nano-particles are contained in the needle body in an amount of 0.01-20% by weight based on the weight of the needle. If the content of the silver nano-particles is less than 0.01% by weight, it will show little or no antibacterial effect, and if the content is more than 20% by weight, it will reduce the needle strength, increase the needle viscosity, making the needle insertion into the human body difficult, and increase production cost.

[22]

Mode for the Invention

[23] FlG. 1 shows various types of acupuncture needles according to one embodiment of the present invention. As shown in FlG. 1, each of acupuncture needles 20 comprises a needle portion 22 and a handle portion 24. According to the present invention, silver nano-particles are contained in the needle portion 22 or coated on the needle portion 22.

[24] FlG. 2 is a perspective view showing a conventional syringe. As shown in FlG. 2, the syringe comprises an injection needle 30 and a cylinder 35, in which the injection needle 30 consists of a needle portion 32 and a connection portion 34. The needle portion 32 is generally made of metal, and the connection portion 34 and the cylinder 35 are made of synthetic resin. According to the present invention, at least the needle portion 32 contains silver nano-particles or is coated with silver nano-particles. To increase the effects of the present invention, in addition to the needle portion 32, the connection portion 34 and the cylinder 35 may also contain silver nano-particles or be coated with silver nano-particles.

[25] FlG. 3 is an electron microscopic photograph taken at 60,00OX magnification for the cross-section of the needle manufactured according to the plasma coating method. As can be seen in FlG. 3, the cross-section of the silver nano-particle film coated on the needle body is very smooth, indicating that the silver nano-particle film acts as a lubricant.

[26] FlG. 4 is an electron microscopic photograph taken at 80,00OX magnification for the side of a needle coated with silver nano-particles according to the present invention.

[27]

[28] A medical needle containing silver nano-particles according to the present invention can be manufactured as following process. A metal material for forming a needle portion is heated and melted, and silver nano-particles are added to the molten material and stirred. Then, the stirred mixture is molded or injected. The molded or injected material is slowly cooled, thus manufacturing the inventive medical needle.

[29] A medical needle coated with silver nano-particles can be manufactured by an electroplating method according to one embodiment of the present invention. A needle body is first subjected to a washing step and a rinsing step to remove impurities from the needle body. The rinsed needle body is polished with a linen cloth and then washed with water. Then, the needle body is immersed in a plating solution to which direct electric current is then applied. Next, the needle is introduced into a plating tank, and then subjected to a base-plating step and a nickel-plating step. The plated needle is immersed in a silver nano-particle solution, to which direct electric current is then applied. Next, the needle is subjected to a washing step and a drying step, thereby manufacturing a medical needle coated with silver nano-particles.

[30] In addition, a medical needle coated with silver nano-particles can be manufactured by a plasma coating method according to another embodiment of the present invention. A needle is subjected to a washing step and a rinsing step to remove impurities from the need surface, and then dried in a dryer as shown as reference numeral to evaporate water. Next, the needle is mounted on a support and introduced in a plasma vacuum chamber, into which gas is introduced. Then, the needle is subjected to a plasma sterilization step, a first surface treatment step and a second surface treatment step. Thereafter, the needle is coated with silver nano-particles and then dried, thereby manufacturing a medical needle coated with silver nano-particle particles.

[31]

[32] Hereinafter, the effects of the inventive medical needle having antibacterial and painless functions will be described by examples and test examples.

[33]

[34] [Example]

[35] 5,000 stainless steel injection needles (226-gauge), 5,000 electric needles (10.5 cm length) and 5,000 spring-type needles (6 cm length) were commercially purchased. The needles were coated with silver nano-particles according to the plasma coating method in the following conditions:

[36] 1) Place of coating: Plasma Center, S. University

[37] 2) Deposition equipment: CHAMBER 850W x 850L x 700H, TARGET size:

375x120, TARGET IPART 2EA (TOTAL: 6EA), MAGNET IPART 2EA (TOTAL: 6EA), POWER DC or RF, MBP + SCREW PUMP 7000 L/MIN, TURBO MOLECULAR PUMP 3000M 3/H

[38] 3) Holder: Rotary Holder

[39] 4) Base pressure: less than 10^" torr

[40] 5) Gas used: Ar (99.99%), Oxygen (99.999%) [41] 6) Process pressure (Ar Pressure): 1-10 mtorr [42] 7) Gas Row): 9-100 cc/min [43] 8) Temperature: Room Temperature [44] 9) Power: 10-150 W [45] 10) Silver target: 99.99% Ag [46] 11) Articles to be coated: Three kinds of stainless steel needles [47] 12) Chamber temperature: 100 °C [48] 13) Coating time: 60 minutes [49] In the above conditions, deposition power was set to 120 W, and a coating film of silver nano-particles was formed on the surface of the needles while changing the deposition power. The coating film of silver-nanoparticles was measured for changes electricity resistivity and adhesion properties with changes in deposition pressure. In the measurement results, the coating film showed the lowest electrical resistivity of 5.014 μΩ cm at a deposition pressure of 10 m torr and showed an increase in electrical resistivity at deposition pressures of more than 5.014 μΩ cm. Also, on the needles coated in Example, nano-silver particles were formed into a film having a very smooth surface, and also showed constant uniformity.

[50] [51] Test Example 1 : Test of electrical conductivity [52] The electric needles coated with silver nano-particles in Example were used to perform electro-acupuncture for fat dissolution on obesity patients. An electro- stimulator used in the electro-acupuncture was STAETRON (trade name) commercially available from D medical company. The electro-acupuncture was performed as shown in FIG. 5. Namely, the electric needles 10 were put into the fat sites of the patients 100 at intervals of 3-5 cm in a line. Then, the electric needles 10 were electrically connected with the electro-stimulator 50 via wire 70, and electric stimulation 50 was applied to the patient 100 for about 1 hour.

[53] Meanwhile, conventional stainless electric needles, which have not been coated with silver nano-particles, were inserted into other sites of the same patients and operated in the same manner as above, so as to compare the responses of the patient. The results are shown in Table 1 below.

[54] [55] Table 1

[56] As can be seen from the results in Table 1, in the case of the inventive electric needles coated with silver nano-particles, the patients showed a response much faster than in the case of the conventional stainless electric needles, because the inventive electric needles have an electrical conductivity higher than that of the conventional needles. Also, the women showed a more sensitive response than in the men. In addition, the electrical conductivity in the body was decreased according to age due to a reduction in water in the body.

[57] [58] Test Example 2: Pain test (1) [59] 10-cm long needles were inserted into the fat sites of 10 obesity patients (5 men and 5 women), and electric current was applied to the patients by the electro-stimulator. The patients compared the feel of the inventive nanosilver-coated needles with that of the prior stainless steel needles, and the results are shown in Table 2 below. [60] Table 2

[61] As can be seem from the results in Table 2 above, most of the patients answered that there was a coarse and tingly pain for the prior stainless steel needles, whereas there was little or no pain for the inventive nanosilver-coated needles but rather there was a very soft feel.

[62] [63] Test Example 3: Pain test (2) [64] The patients tested in Test Example 2 were examined for feel and pain occurring when the needles were inserted and removed. The results are shown in Table 3 below. [65] Table 3

[66] As can be seen from the results in Table 3 above, the inventive nanosilver-coated needles showed a soft and painless feel upon the insertion or removal of the needles because of the lubricant action of silver. Also, after acupuncture, there was little or no itching, swelling or allergic reaction in the case of the inventive needles.

[67] [68] Test Example 4: Test of body fat dissolution effect [69] Obesity patients were subjected to electro-acupuncture test using the inventive nanosilver-coated needles and the prior stainless steel needles for 1 month, and changes in the body weight of the patients were comparatively analyzed. The results are shown in Table 4. [70] Table 4

[71] As can be seen from the results in Table 4 above, the members of the test group which has been electro-stimulated using the inventive nanosilver-coated needles and applied with these needles at the ear portion all showed a reduction of more than 10 kg in the body weight, whereas the members of the group electro-stimulated using the stainless steel needles mostly showed a reduction of less than 10 kg in the body weight. In addition, in the case of the group electro-stimulated using the inventive needles, an abrupt reduction in the internal body fat could be confirmed through CT scanning. This fact that the inventive nanosilver-coated needles is higher in body fat removal rate than the conventional stainless steel needle suggests that the inventive needles readily dissolve body fat because of high electrical conductivity and thermal conductivity.

[72] [73] Test Example 5: Pain test (3) [74] The nanosilver-coated injection needles prepared in Example were used on inflammatory disease patients who have been hospitalized in a general hospital for a long time. The response of the patients to the inventive needles was examined comparatively with a control group, and the results are shown in Table 5 below. [75] Table 5

[76] As can be seen from the results in Table 5, the inventive nanosilver-coated injection needles have excellent antibacterial activity compared to the prior stainless steel injection needles. Also, the inventive needle show markedly reduced pain upon insertion into the human skin, blood vessel or muscle or removal from this tissue in all the subcutaneous, intramuscular, intravascular or Ringer injections due to the lubricant action of nano-silver particles. This is because the inventive injection needles have nano-silver particles coated thereon, so that, when the needles are inserted into the tissue of the human body, the damage, friction and push of the skin, muscle, nerve and blood vessel will be minimized.

[77] [78] Test Example 6: Pain test (4) [79] On the patients tested in Test Example 5, the pain and feel of the patients upon the insertion or removal of the injection needles, and reactions and conditions appearing on the skin after the removal of the needles, were examined. The results are shown in Table 6.

[80] Table 6

[81] As can be seen in Table 6, most of the patients answered that the prior injection needles gave a coarse and stinging feel upon insertion, whereas the inventive nanosilver-coated needles involved a significantly reduced pain upon insertion or removal. Also, in the case of the inventive needles, a wound caused by the insertion and removal of the needles has healed up very fast compared to the prior injection needles. In addition, neither reaction, such as swelling, allergy or itching, nor inflammatory reaction, was shown.

[82]

Industrial Applicability [83] As described above, the inventive medical needles having antibacterial and painless functions are excellent in antibacterial, bactericidal, deodorizing and toxin-removing effects, generate useful anions upon acupuncture to activate blood circulation and internal secretion, have antiviral and antiallergic effects, and can rapidly relive a pain and rapidly dissolve body fat. Also, the inventive needles cause a reduced pain upon insertion into the human body due to the excellent lubricant action of nano-silver particles. Particularly upon electro-acupuncture, the inventive needles show high electrical conductivity and thermal conductivity even at a low current intensity.

[84]

Claims

[1] A medical needle selected from the group consisting of a needle for injection, a needle for operation and a needle for acupuncture, wherein silver nano-particles having a diameter of 0.1-300 nm are coated on the surface of the needle to a thickness of 0.01-50 D.

[2] A medical needle selected from the group consisting of a needle for injection, a needle for operation and a needle for acupuncture, wherein silver nano-particles having a diameter of 0.1-300 nm are contained in the needle body in an amount of 0.01-20% by weight based on the weight of the needle.