WOUND DRESSING ARTICLES AND METHOD OF MANUFACTURING THE SAME
20230118969 · 2023-04-20
Assignee
- Vietnam National University Ho Chi Minh City (Ho Chi Minh, VN)
- Ho Chi Minh City International University (Ho Chi Minh, VN)
Inventors
Cpc classification
A61L15/32
HUMAN NECESSITIES
A61L15/26
HUMAN NECESSITIES
A61L26/0019
HUMAN NECESSITIES
D01D5/0038
TEXTILES; PAPER
D01F6/625
TEXTILES; PAPER
A61F13/022
HUMAN NECESSITIES
A61L15/26
HUMAN NECESSITIES
A61L15/46
HUMAN NECESSITIES
C08L67/04
CHEMISTRY; METALLURGY
A61L2300/404
HUMAN NECESSITIES
C08L67/04
CHEMISTRY; METALLURGY
A61F13/00063
HUMAN NECESSITIES
International classification
Abstract
The present invention provides a medical dressing article and a method of manufacturing the same, which comprises: (a) a first layer comprised of polycaprocaptone fibers having a PCL fiber diameter of 0.5 μm and 2.9 μm; (b) a second layer, deposited directly on the first layer, including a mixture of polycaprolactone and poloxamer fibers (PCL and POX fibers) wherein a PCL and POX fiber diameter is between 0.1 μm and 4 μm; and (c) a third layer, deposited directly on the second layer, further comprising a mixture of gelatin and silver nitrate (AgNO.sub.3).
Claims
1. A medical dressing article, comprising: a first layer comprised of polycaprocaptone fibers having a PCL fiber diameter of 0.5 μm and 2.9 μm; a second layer, deposited directly on said first layer, including a mixture of polycaprolactone and poloxamer fibers (PCL and POX fibers) wherein a PCL and POX fiber diameter is between 0.1 μm and 4 μm, and a third layer, deposited directly on said second layer, further comprising a mixture of gelatin and silver nitrate (AgNO.sub.3).
2. The article of claim 1 wherein said first layer has a thickness of 0.1 mm and 2 mm.
3. The article of claim 2 wherein a diameter of a pore (void space) between said PCL fiber in said first layer is 7 μm to 20 μm.
4. The article of claim 1 wherein said second layer has a thickness of 0.02 mm to 0.3 mm.
5. The article of claim 1 wherein a ratio of said poloxamer (POX) fibers and said polycaprocaptone (PCL) fibers in said second layer is 15%.
6. The article of claim 1 wherein a ratio of said poloxamer (POX) fibers and said polycaprocaptone (PCL) fibers in said second layer is 30%.
7. The article of claim 1 wherein said third layer further comprises two to six sub-layers of gelatin and silver nitrate (AgNO.sub.3).
8. The article of claim 1 wherein a thickness of each of said sub-layers is between 10 μm to 15 μm.
9. The article of claim 8 wherein said gelatin has a concentration of 0.1% to 20%.
10. The article of claim 9 wherein said silver nitrate (AgNO.sub.3) has a concentration of 0.1% to 5%.
11. The article of claim 10 wherein a volume ratio between gelatin and AgNO.sub.3 is from 1:1 to 50:1.
12. The article of claim 1 wherein a mass ratio between said polycaprolactone and said poloxamer in said second layer ranges from 1:1 to 1:50.
13. A method of fabricating a medical dressing article, comprising: (i) forming a first layer of polycaprocaptone fibers having a PCL fiber diameter of 0.5 μm and 2.9 μm; (ii) forming a second layer directly on said first layer, said second layer including a mixture of polycaprolactone and poloxamer fibers (PCL and POX fibers) wherein a PCL and POX fiber diameter is between 0.1 μm and 4 μm; and (iii) forming a third layer directly on said second layer, said third layer further comprising a mixture of gelatin and silver nitrate (AgNO.sub.3).
14. The method of claim 13 wherein further comprising (iv) a protective layer directly on top of said first layer.
15. The method of claim 14 wherein said step (i) further comprises electrospinning said first layer at a voltage potential of 8 kV to 20 kV until said first layer has a thickness of 0.1 mm and 2 mm.
16. The method of claim 13 wherein said step (ii) further comprises electrospinning said second layer at a voltage potential of 8 kV to 20 kV said second layer has a thickness of 0.02 mm to 0.3 mm.
17. The method of claim 13 wherein a ratio of said poloxamer (POX) fibers and said polycaprocaptone (PCL) fibers in said second layer is 30%.
18. The method of claim 13 wherein said step (iii) further comprising forming said third layer that includes two to six sub-layers of gelatin and silver nitrate (AgNO.sub.3).
19. The method of claim 18 wherein a thickness of each of said sub-layers is between 10 μm to 15 μm.
20. The method of claim 18 wherein said gelatin has a concentration of 0.1% A to 20% and wherein said silver nitrate (AgNO.sub.3) has a concentration of 0.1% to 5%.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the invention and, together with the description, explain the principles of the invention.
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
DETAILED DESCRIPTION OF THE INVENTION
[0034] Reference will now be made in detail to the preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. While the invention will be described in conjunction with the preferred embodiments, it will be understood that they are not intended to limit the invention to these embodiments. On the contrary, the invention is intended to cover alternatives, modifications and equivalents, which may be included within the spirit and scope of the invention as defined by the appended claims. Furthermore, in the following detailed description of the present invention, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be obvious to one of ordinary skill in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, and circuits have not been described in detail so as not to unnecessarily obscure aspects of the present invention.
[0035] As used herein, the term “medical dressing articles” refers to bandages, gauzes, band-aids, cloths, pads, plasters, tapes, or the likes designed to cover external wounds regardless of the forms such as gels, gelatins, unwoven cloths, etc.
[0036] Referring now to
[0037] According to a preferred embodiment of the present invention, the mass ratio between polycaprolactone and poloxamer in second layer 102 ranges from 1:1 to 1:50.
[0038] According to a preferred embodiment of the present invention, the thickness of first layer 101 is between 0.1 mm and 2 mm, the diameter of the pores is about 7 μm to 20 μm.
[0039] According to a preferred embodiment of the present invention, second layer 102 is directly deposited on third layer 103 and the thickness of second layer 102 is between 0.02 mm and 0.3 mm.
[0040] According to a preferred embodiment of the present invention, third layer 103, deposited directly on second layer 102, further consisted of from 2 to 6 sub-layers. The thickness of each sub-layer ranges from 10 μm to 15 μm.
[0041] According to a preferred embodiment of the present invention, first layer 101 and second layer 102 are formed by the electric field spinning (ES) method (electrospinning).
[0042] According to a preferred embodiment of the present invention, third layer 103—directly deposited on second layer 102—is impregnated with a solution gelatin and AgNO.sub.3 by immersion/overlay method. The gelatin has a concentration of 0.1% to 20%. The AgNO.sub.3 has a concentration of 0.1% to 5%. The volume ratio between gelatin and AgNO.sub.3 is from 1:1 to 50:1.
[0043] Referring next to
[0044] Referring to
[0045] As disclosed in
[0046] (1) high humidity at the wound area 322 while removing excess exudates due to third layer 103 contacting wound area 322.
[0047] (2) Free of particles and toxic contaminants due to first layer 101 arranged on top in opposition to wound area 322 and second layer 102 arranged in the middle which is amphoteric or zwitterionic.
[0048] (3) Non-toxic and non-allerenic due to the materials selected such as gelatin, silver nitrate (AgNO.sub.3), PCL, and POX, which are all biocompatible to human.
[0049] (4) Capable of protecting wound from further trauma due to the disclosed structure disclosed above.
[0050] (5) can be removed without causing trauma to the wound due to the optimal moisture at wound area 322 due to the function of second layer 102;
[0051] (6) Impermeable to harmful bacteria due to first layer 101 and second layer 102.
[0052] (7) Thermally insulating due to the properties of PCL in first layer 101 and POX and PCL in second layer 102.
[0053] (8) Allowing exchanging of air (breatheable) due to the fiber diameters and thickness of first layer 101 and second layer 102.
[0054] (9) Requiring infrequent changes because of the optimal moisture and the tensile strength of the selected materials, fiber diameters, thickness, and structural arrangement, e.g., PCL, and PCL mixed with POX.
[0055] (10) cost effective since the selected materials are not expensive to purchase and/or manufacture.
[0056] To evaluate the effectiveness of second layer 102 in combination with first layer 101 in the manner described above in
[0057] Next referring to
[0058] In DIZ results 501, S. aureus is a gram-positive bacterium, commonly found in the skin, nose and respiratory system. S. aureus bacteria can cause many diseases including skin infections and post-operative wounds and resistance to antibiotics were tested. Similarly, in DIZ results 502, P. aeruginosa bacteria, a common gram-negative bacteria, bacterial rod-shaped in soil, water, skin flora, also found on medical devices (e.g., urinary catheter) were tested. P. aeruginosa bacteria is commonly found in hospitals. Infections caused by P. aeruginosa are difficult to treat due to resistance to many antibiotics. Previous research results show that the smallest silver concentration is from 1 μg/ml to 2 μg/ml is sufficient to inhibit bacterial growth or achieve bactericidal effects. In the same manner,
[0059] Continuing with
[0060] Next referring to
[0061] Next, referring to
[0062] Now referring to
[0063] Now referring to
[0064] With the burn wound treated with medical dressing article 100 of the present invention, the epidermis layer was completely restructured shown in a graph 820. On the left side of the wound is a small area with many inflammatory cells such as neutrophils and invading cells shown in graph 821. There were no signs of infection or necrosis shown in a graph 822. In addition, the wound treated with an invention bandage shows the formation of the new blood vessels present in graph 823.
[0065] Finally referring to
[0066] At step 901, a first layer of polycaprolacton fibers (polycaprolactone—PCL) is formed. In many aspects of the present invention, the fiber diameter of the PCL fiber of step 901 is between 0.7 μm and 2.9 μm. Specifically, step 901 is realized by using electric field injection (electrospinning) solutions containing PCL concentrations of 10% to 15% in an electric field with a voltage supply ranging from 8 kV to 20 kV. PCL solution is prepared by dissolving PCL into the aceton solvent, then stirring for 12 hours at 50° C. until a homogeneous mixture is reached. This PCL solution is fed into a 12 centimeter diameter syringe. The syringe is then installed on the electric camcorder and sprayed with a power source from 8 kV to 20 kV. The fiber collection form is established by giving the horizontal collection roll by injection pump. The PCL solution is ejected from the pump system at a flow rate of 1 ml/hours until the thickness of the first layer is in the range of 0.1 mm to 2 mm.
[0067] Next at step 902, a second layer is deposited directly on the first layer. In many aspects of the present invention, the second layer is made of fibers consisting of a mixture of solutions containing PCL and POX, in which the fiber diameter is in the range of 0.1 μm to 4 μm. Specifically, fibers including PCL and POX are generated by electric field injection (electrospinning) a mixture of solutions containing PCL and POX from 10% to 15% in electric fields with a supply voltage from 15 kV to 20 kV. The mass ratio between polycaprolacton and poloxamer ranges from 1:1 to 1:50. This mixture is sprayed using the voltage supply of 15 kV to 20kV by setting the horizontal injection by injection pump at a flow rate of 1 ml/hour. The thickness of the second layer is between 0.02 mm and 0.3 mm.
[0068] Finally, at step 903, a third layer containing gelatin and AgNO3 mixture is deposited directly on the first and second layers. Step 903 is realized by by immersion of the second layer in a solution containing gelatin and AgNO.sub.3 mixture in 30 minutes. In this mixture, gelatin has a concentration of 0.1% to 20% and AgNO.sub.3 has a concentration of 0.1% to 5%, and the volume ratio between gelatin and AgNO.sub.3 from 1:1 to 20:1. First, the gelatin solution is prepared by dissolving gelatin in distilled water and stirring at 400 rpm at 40° C. for 1 hour. Then add the prepared AgNO.sub.3 solution and stir at room temperature for 10 minutes. The mixture is then exposed to ultraviolet light with a fluorescent lighting device within 1 hour and a mixture of gelatin and AgNO.sub.3 solution is obtained. The third layer is covered with a second layer between 2 layers to 6 layers, the thickness of each layer is between 10 μm and 15 μm.
EXAMPLES
Example 1: Fabricating Medical Dressing Articles to Support Wound Treatment with a Mixed Coating of Galletin and AgNO.SUB.3..
[0069] Referring back to
[0070] Next, depositing the second layer 102 onto first layer 101, in which second layer 102 is made up of fibers consisting of a mixture of solutions containing PCL and POX. Specifically, put 1 ml of POX into 9 ml of PCL solution to achieve a solution containing 10% of POX solution.
[0071] The mixture of this solution is then fed into a syringe with a diameter of 12 centimeters. The syringe is then installed on the electric camera and sprayed with 18 kV power supply. The mixture of PCL and POX solutions was ejected from the pump system at a flow rate of 1 ml to deposit second layer 102 directly on first layer 101. The fiber diameter of second layer is in the range of 0.1 μm to 4 μm.
[0072] Finally, third layer 103 containing a mixture of gelatin and AgNO.sub.3 was deposited on second layer 102 to obtain medical dressing article 100. Specifically, a 3% gelatin solution was prepared by dissolving 0.3 grams of gelatin in 9.7 grams of distilled water and stirring at 400 rpm/minutes at 40° C. for 1 hour and obtained approximately 10 ml of galetin solution. Next, 1 ml of prepared 1% AgNO.sub.3 solution was added and stirred at room temperature for 10 minutes. Next, the mixture was exposed to ultraviolet light with a fluorescent lighting device within 1 hour. The mixture of gelatin and AgNO.sub.3 solution was obtained. Then, first and second layers 101 and 102 were immersed into the mixture of galetin and AgNO.sub.3 solutions within 30 minutes to obtain medical dressing article 100.
[0073] Example 2: Fabricating the Medical Dressing Article with Three Galletin and AgNO3 Layers.
[0074] After the first experiment was completed, drying medical dressing article 100 mixed coating of galetin and AgNO.sub.3 for six hours. Then, soaking medical dressing article 100 into the mixture of galetin and AgNO.sub.3 solutions for 30 minutes to create a second sub-layer. Continuing to perform drying and coating of the same galetin and AgNO3 to obtain medical dressing article 100 with three sub-layers of gelatin mixed with AgNO3.
[0075] The foregoing description details certain embodiments of the invention. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the invention can be practiced in many ways. As is also stated above, it should be noted that the use of particular terminology when describing certain features or aspects of the invention should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the invention with which that terminology is associated. The scope of the invention should therefore be construed in accordance with the appended claims and any equivalents thereof.
DESCRIPTION OF NUMERALS
[0076] 100 Medical dressing article of the present invention
[0077] 101 First layer of polycapralactone (PCL)
[0078] 102 Second layer of PCL and poloxamer (POX)
[0079] 103 third layer of a mixture of gelatin and AgNO.sub.3
[0080] 201 PCL fiber
[0081] 202 PCL and POX fiber
[0082] 300 medical dressing article with adhesive tapes
[0083] 311 adhesive tapes (optional)
[0084] 312 protective layer (optional)
[0085] 321 human skin layer
[0086] 322 wound area
[0087] 3221 dermis layer
[0088] 3222 epidermis layer
[0089] 3223 polycaprotoner (PCL) impermeable layer
[0090] 331 releasing direction of gelatin and AgNO.sub.3
[0091] 332 fluid absorption direction
[0092] 333 fluid rejection direction
[0093] 400 Fourier transform infrared spectroscopy spectrum
[0094] 410 spectrum of PCL layer
[0095] 420 spectrum of POX layer
[0096] 430 spectrum of medical dressing article with three layers
[0097] 500A diameter inhibition zone (DIZ) tests
[0098] 500B bar graphs of DIZ tests
[0099] 511 expansion diameter of S. aureus against article
[0100] 512 inhibition zone of S. aureus
[0101] 521 expansion diameter of P. aeruginosa against article
[0102] 522 inhibition zone of P. aeruginosa
[0103] 531 DIZ bar graph of S. aureus
[0104] 532 DIZ bar graph of P. aeruginosa
[0105] 600 POX hydrophilicity test
[0106] 601 PCL and POX surface
[0107] 602 water droplet
[0108] 611 PCL control group
[0109] 612 PCL with 1% POX
[0110] 613 PCL with 2% POX
[0111] 614 PCL with 3% POX
[0112] 615 PCL with 4% POX
[0113] 616 PCL with 8% POX
[0114] 617 PCL with 15% POX
[0115] 618 PCL with 30% POX
[0116] 700 healing test against control group
[0117] 800 histological examination against conventional bandage