Chitosan coated composite wound dressing material with an electric field that can be applied locally to the wound

Abstract

The present disclosure is a wound dressing material made of fabric, which accelerates the healing process of a wound to which it is locally applied, comprising an applicator (10) containing a square-wave-generating multivibrator electronic circuit (12), which is connected to the aforementioned spunbond fabric (11 ) to generate an electric field and exhibit a bactericidal effect and an effect preventing biofilm formation, the spunbond fabric (11) containing a multilayer film made of chitosan, and a control unit (20) supplying the applicator (10).

Description

[0001] CHITOSAN COATED COMPOSITE WOUND DRESSING MATERIAL WITH AN ELECTRIC FIELD THAT CAN BE APPLIED LOCALLY TO THE WOUND

[0002] Technical Field

[0003] The present disclosure relates to a wound dressing material made of fabric, which accelerates the healing process of a wound to which it is locally applied.

[0004] The present disclosure particularly relates to a wound dressing material comprising a spunbond fabric containing a multilayer film made of chitosan and an applicator containing a square-wave-generating multivibrator electronic circuit, which is connected to the aforementioned spunbond fabric to generate an electric field and exhibit a bactericidal effect and an effect preventing biofilm formation, and further comprising a control unit supplying the applicator.

[0005] State of the Art

[0006] Wound healing contains within itself many intertwined mechanisms. In the first minutes, following vasoconstriction of the vessels to reduce bleeding, primary haemostasis occurs through the adhesion of platelets to structures such as collagen and von Willebrand factor (vWF), which protrude from the subendothelial layer of the damaged area into the vascular lumen. At this stage, methods that increase platelet aggregation and increase the migration of surrounding platelets to the lesion area can accelerate the primary haemostasis step. Furthermore, cytokines and chemokines released from these platelets fight pathogens and help clean the damaged tissue, and the growth factors released contribute to the growth of new cells and the reformation of blood vessels. The fibrin structure formed by coagulation factors, and surrounding the platelet plug not only increases the strength of the plug but also provides a basis for important stages, such as epithelialisation, which ensures the closure of the wound site. Therefore, conditions that increase coagulation mechanisms and indirectly increase fibrin formation can accelerate haemostasis by accelerating the bleeding-stopping effect and can accelerate wound healing by causing an earlier development of the epithelialisation step.When similar patents are examined, it is seen that an applicator generating a direct electromagnetic field or magnetic field applies a magnetic field to the wound surface in the range of 15-50 kHz and at microtesla levels, and the application applicator is a coil. Therefore, the coil draws current from the source (US11826579B2).

[0007] In another patent, an invention is presented that also uses a magnetic field but employs a different frequency and a different power than conventional magnetic stimulation (US11826579B2). Other similar patents also use the same methodology.

[0008] When commercial products are examined, it is also seen that products claiming to apply an electric field in fact refer to current values; in other words, they apply a magnetic field to the wound surface with the aid of an electrode

[0009]

[0010] (I ,co m / d.Q i / 10.1089 / wund,2013,Q459) ■ Some commercial products use methods operating with negative pressure, such as known VAC devices. However, our present disclosure innovatively has an applicator made of a flexible material, uses electric field stimulation whose therapeutic properties have been confirmed in our preliminary studies, and this applicator also contains innovative chemical layers.

[0011] In the second step of healing, which is the inflammation step, neutrophils, which are other cells that migrate to the wound site, show their effect in the acute phase, and macrophages show their effect in the late phase. With the help of the cytokines they secrete, they attempt to eliminate foreign bodies and infectious agents in the lesion area. While neutrophils perform cell death, macrophages clean dead cells and other debris. In this process, which begins within a few hours, vasodilation created by the cytokines released brings more blood to the lesion area where repair is required and the repair may accelerate. On the other hand, due to the effect of growth factors released by the same cells, cellular proliferation rate is increased and mitotic activity is initiated to close the missing tissue area. Increasing vascular dilation or cellular migration for various reasons may result in the acceleration of this important process, and the inflammation phase, and wound healing may be accelerated.

[0012] The proliferation phase, which is the approximately one-week period involving the process of filling the missing tissues and closing the wound area, is the period in which cellular proliferation is at its highest due to increased mitotic activity caused by the effect of growth factors. In this phase, angiogenesis, which means the formation of newblood vessels to provide oxygen and nutrient support to the newly formed areas, the activation of fibroblasts that form granulation tissue by increasing the synthesis of collagen, the most important structural component, and other matrix proteins, epithelialisation starting from both wound edges to cover the wound and close the wound area, and the contraction step, in which myofibroblasts come into play and the wound area contracts and becomes smaller, are the important parts of this phase. Angiogenesis also continues at this step, resulting in revascularisation. Therefore, any factor that increases angiogenesis, fibroblast migration and activation, epithelialisation and the contraction step will accelerate wound healing.

[0013] The remodelling phase, on the other hand, is the process of strengthening and maturing the wound and may last for months or even years. With the collagen organisation occurring here, new collagen fibres replace the old collagen fibres and acquire a more regular structure. Afterwards, the cross-links between collagen fibres increase and the wound tissue becomes strengthened. On the other hand, some of the excess cells and temporary structures are eliminated through programmed cell death (apoptosis). Substances or other methods that can increase wound contraction and the rate of cross-linking between collagen fibres may cause this phase to accelerate. Among the additional factors affecting wound healing is age, and the healing process may be slower in elderly individuals. Impaired vascularisation of the wound area and insufficient intake of protein, vitamins, and minerals may delay healing. Moreover, conditions such as diabetes, infections, and immune system disorders may adversely affect healing. In particular, the development of bacterial infections of skin flora origin, such as Staphylococcus aureus and Staphylococcus epidermidis, transmitted by contact, leads to an excessive amount of inflammation greater than what is required for healing and, conversely causes a delay in healing. In such cases, after treatment with substances exhibiting antibacterial activity, the healing mechanism may proceed normally or, depending on the severity of the infection, may complete healing with scar tissue. Similar cases may also occur with agents differing from those causing hospital-acquired infections. Therefore, as in recent studies, antibacterial agents are also incorporated into the wound dressing materials developed using various active substances.Chronic diseases such as diabetes, renal failure, and circulatory disorders may adversely affect wound healing. These diseases weaken blood circulation, slow the healing process, and increase the risk of complications. Infection of the wound area due to contamination may significantly prolong the healing process due to the abundant inflammation that develops. Protein, vitamin, and mineral deficiencies occurring at the wound site for various reasons may again adversely affect the constructive processes in repair. On the other hand, elderly patients and those with poor general health may experience a longer healing process due to weakened immune systems. Patients’ failure to comply with wound care instructions, failure to clean the wound regularly, improper changing of dressings, or failure to use medications recommended by the doctor negatively affect healing and increase hospital stay durations, thereby increasing wound care costs worldwide. Prolonged hospital stays, treatment expenses, and the resources used increase the burden on the healthcare system.

[0014] Wound healing creates physical, psychological, and financial impacts on both patients and healthcare systems. Currently, alginate dressings, polyurethane films, hydrogel dressings, hydrocolloid dressings, foams, hyaluronic acid, collagen, elastin, alginates, and chitosan-containing bioactive dressing materials are used in wound treatments. In addition, negative-pressure wound therapy devices and techniques, such as ultrasound, are among the treatment options. Because the consumables used with such devices are expensive and must be replaced each time, they are quite costly methods in routine use. Although the wound care methods available on the market have been clinically proven to be effective, their high costs constitute an economic burden for both hospitals and the relatives of patients. Therefore, patients are generally treated using more traditional methods. Wound dressing materials containing combined methods are not available on the market.

[0015] Scientists are trying to develop many new methods or materials to influence the healing-related steps mentioned above and to ensure smooth and early healing. It is known that the active substances used or the medical devices partially increase the wound repair rate due to the various regions they act upon. However, despite all these positive developments, an ideal method that both accelerates repair and ensures smooth healing has still not been found.The need for more effective and shorter-term treatment of these conditions frequently encountered in the known technique, as well as the demand for new developments in this field, is increasing day by day.

[0016] As a result, due to the disadvantages and deficiencies mentioned above, a need has arisen to make an innovation in the relevant technical field.

[0017] The Aim of the Invention

[0018] The present invention relates to a composite wound dressing material comprising a chitosan coating and an electric field, applicable locally to a wound, which meets the requirements mentioned above, eliminates all disadvantages, and provides additional advantages.

[0019] The invention aims to obtain a wound dressing material made of fabric, which accelerates the healing process of a wound to which it is locally applied.

[0020] The invention aims to provide a wound dressing material comprising a spunbond fabric containing a multilayer film made of chitosan and an applicator containing a square-wave-generating multivibrator electronic circuit, which is connected to the aforementioned spunbond fabric to generate an electric field and exhibit a bactericidal effect and an effect preventing biofilm formation, and further comprising a control unit supplying the applicator.

[0021] The invention aims to provide treatment for a wound healing process that will take a long time.

[0022] The invention aims to offer a wound dressing material that can be used as a routine treatment apparatus in patients for wound healing processes that will take a long time. The invention aims to provide a wound dressing material that is easy to use and economical.

[0023] To fulfil the aims described above, the present disclosure is a wound dressing material made of fabric, which accelerates the healing process of a wound to which it is locally applied, comprising:• an applicator containing a square-wave-generating multivibrator electronic circuit, which is connected to the aforementioned spunbond fabric to generate an electric field and exhibit a bactericidal effect and an effect preventing biofilm formation, the spunbond fabric containing a multilayer film made of chitosan, and

[0024] • a control unit supplying the applicator.

[0025] To achieve the aims of the present disclosure, the wound dressing material comprises copper plates in a square spiral geometry within the square-wave-generating multivibrator electronic circuit, which generates an electric field of 1 hertz and 10 kV / m. To achieve the aims of the present disclosure, the wound dressing material comprises a supply line providing the connection of the applicator to the control unit.

[0026] To achieve the aims of the present disclosure, the wound dressing material is produced by the process steps of:

[0027] • obtaining the applicator by immersing the spunbond fabric in a 3% polyethyleneimine solution at room temperature for 10 minutes, then drying it at 80X3 for 5 minutes and fixing it at 105X3 for 5 min utes, and subsequently performing successive coating processes with anionic PSS (polystyrene sulfonate) I cationic chitosan solutions to obtain a multilayer coating on the spunbond fabric surface rendered cationic, followed by drying at 60 3 and sterilisation at 130X3 for 3 minutes,

[0028] • forming the multivibrator electronic circuit in a square spiral geometry pattern using copper plates,

[0029] • connecting the multivibrator electronic circuit to the surface of the spunbond fabric using a binder, and

[0030] • connecting the resulting applicator to the control unit via the supply line.

[0031] The structural and characteristic features of the invention and all its advantages will be understood more clearly thanks to the detailed explanation given below, and therefore the evaluation must be made with this detailed explanation in mind.Figures to Help Understanding of the Invention

[0032] Figure 1 : A representative view of the wearable use of the wound dressing material of the invention.

[0033] Figure 2: A side sectional view of the applicator.

[0034] The drawings do not necessarily need to be scaled, and details that are not required to understand the present invention may have been omitted. Moreover, elements that are at least substantially identical or at least substantially functional in the same way are indicated with the same number.

[0035] Reference Numbers

[0036] 10. Applicator

[0037] H.Spunbond fabric

[0038] 12. Electronic circuit

[0039] 13. Binder

[0040] 20. Control unit

[0041] 21. Supply line

[0042] B. Copper plate

[0043] S. Fastening belt

[0044] Detailed Description of the Invention

[0045] In this detailed description, the composite wound dressing material comprising a chitosan coating and an electric field, applicable locally to a wound, is explained solely for better understanding of the subject and without creating any limiting effect.

[0046] The present disclosure relates to a wound dressing material made of fabric, which accelerates the healing process of a wound to which it is locally applied.

[0047] In Figure 1 , a representative view of the wearable use of the wound dressing material of the present disclosure is provided. Accordingly, the wound dressing material essentially consists of:• an applicator (10) containing a square-wave-generating multivibrator electronic circuit (12), which is connected to the aforementioned spunbond fabric (11) to generate an electric field and exhibit a bactericidal effect and an effect preventing biofilm formation, the spunbond fabric (11) containing a multilayer film made of chitosan, and

[0048] • a control unit (20) supplying the applicator (10).

[0049] The applicator (10), whose side sectional view is given in Figure 2, is obtained as follows:

[0050] In the first stage, to render the surface of the spunbond (nonwoven) fabric (11 ) cationic, the spunbond fabric (11) is kept in a 3% polyethyleneimine solution at room temperature for 10 minutes, then dried at 80 3 for 5 minutes and fixed at 105 3 for 5 minutes. To obtain a multilayer coating on the surface of the spunbond fabric (11) to which cationic charge has been imparted, successive coating processes are carried out using anionic PSS (polystyrene sulfonate) I cationic chitosan solutions, followed by drying at 60X3 and sterilisation at 130X3 for 3 min utes.

[0051] In the second stage, as seen in Figure 1 , the multivibrator electronic circuit (12), obtained in a square spiral geometry pattern using copper plates (B), is connected to the surface of the spunbond fabric (11) with a binder (13), preferably resin.

[0052] The multivibrator electronic circuit (12) is referred to as a 555 Timer and is a square wave generator frequently used in electronics, and since its frequency is 1 hertz, its supply is 10 V. That is, because the supply of the circuit (12) is 10 V DC, its output is in the form of a chopped square wave with a peak value of 10 V. The 555 Timer integrated circuit (12) is an IC frequently used to obtain such pulsed supplies. It is possible to obtain an electric field that follows the square wave. The electric field obtained in this way also becomes pulsed like the supply voltage. The waveform corresponds to a monophasic (unidirectional) pulsed electric field with a peak value of 10 kV / m on the vertical axis and repeating once per second.

[0053] The equation E = V / d (V / m) has led to selecting V = 10 V as a pulsed value in the present disclosure due to the fixed distance of 1 mm and the fixed target electric field of 10 kV / m. A multivibrator electronic circuit (12) producing a 1 Hz frequency with a single integrated circuit (555 TIMER) was made to provide the surface energy. After this circuit (12) was manufactured as a prototype, it was produced in the smallestpossible dimensions. The area occupied by the circuit (12) is 0.5 x 0.5 cm. Since the area to be occupied by the multivibrator circuit (12) and the control unit (battery) (20) is also 0.5 x 0.5 cm, the total area becomes 1 x 1 cm. The control unit (20) has been selected as a special button-type unit. The copper plate (B) in the square spiral geometry operates in an open circuit. That is, it does not draw current. Because for an electric field, the load does not need to draw current. The multivibrator circuit (12) draws approximately 1 mA when operating.

[0054] The connection of the applicator (10) to the control unit (20) is provided via the supply line (21).

[0055] The applicator itself is a flexible plaque, and the supply line is also made of a flexible plaque. Therefore, the fixation of the plaque and the supply line onto the fabric garment has been achieved by chemical bonding. Only the control unit is approximately the size of a standard matchbox (3 x 2 x 1 cm) and has a rigid structure, and together with its battery will be fixed onto the fastening belt with a hook-and-loop band.

[0056] While the control unit (20) and the supply line (21 ) forming the wound dressing material of the present disclosure are mounted on the fastening belt (S), the flexible applicator (10) will either be sewn into or fixed onto a hook-and-loop band at the point on the garment closest to the body region targeted by the relevant physician. The wound dressing material can be attached over the body surface as wide or as narrow as desired for the required region. This sizing is independent of the electric field.

Claims

CLAIMS1. A wound dressing material made of fabric, which accelerates the healing process of a wound to which it is locally applied characterized by comprising:• a spunbond fabric (11) containing a multilayer film made of chitosan and an applicator (10) that has a square-wave-generating multivibrator electronic circuit, (12) which is connected to the spunbond fabric (11) to generate an electric field and exhibit a bactericidal effect and an effect preventing biofilm formation, and• a control unit (20) supplying the applicator (10).

2. The wound dressing material according to claim 1 characterized by comprising:a supply line (21) providing the connection of the applicator (10) to the control unit (20).

3. The wound dressing material according to claim 1 characterized by the square- wave-generating multivibrator electronic circuit (12) comprising: copper plates (B) in a square spiral geometry that generates an electric field of 1 Hertz and 10 kV / m.

4. A production method of the wound dressing material characterized by comprising the process steps of:• keeping the spunbond fabric (11) in a 3% polyethyleneimine solution at room temperature for 10 minutes to obtain the applicator (10), followed by drying at 80X3 for 5 minutes and fixing at 105X3 for 5 minute s, and subsequently performing successive coating processes with anionic PSS (polystyrene sulfonate) I cationic chitosan solutions to obtain a multilayer coating on the surface of the spunbond fabric (11 ) to which cationic charge has been imparted, followed by drying at 60 3 and sterilisation at 130 X3 for 3 minutes,• forming the multivibrator electronic circuit (12) in a square spiral geometry pattern using copper plates (B),• connecting the multivibrator electronic circuit (12) to the surface of the spunbond fabric (11) with the binder (13),• connecting the resulting applicator (10) to the control unit (20) via the supply line (21).

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