CN111358769A

CN111358769A - Antimicrobial kits and articles

Info

Publication number: CN111358769A
Application number: CN201811589716.4A
Authority: CN
Inventors: 李仁译; 刘文婷
Original assignee: Panion and BF Biotech Inc
Current assignee: Panion and BF Biotech Inc
Priority date: 2018-12-25
Filing date: 2018-12-25
Publication date: 2020-07-03

Abstract

An antimicrobial kit is provided comprising an antimicrobial agent and a fabric carrier. The antimicrobial agent comprises chlorhexidine gluconate, and the fabric carrier can carry from 0.025ml to 0.075ml of the antimicrobial agent per square centimeter for topical administration of from 0.1 to 1.25 milligrams of chlorhexidine gluconate per square centimeter of skin. Wherein the fabric carrier is not pre-loaded with the antimicrobial agent. An antimicrobial article is also provided comprising a fabric carrier. The fabric carrier carries 0.025ml to 0.075ml of an antimicrobial agent comprising chlorhexidine gluconate per square centimeter, wherein the fabric carrier is configured to topically administer 0.1 to 1.25 milligrams of chlorhexidine gluconate per square centimeter of skin to achieve the effect of reducing skin wound infection and using the antimicrobial agent in an amount appropriate for the skin wound.

Description

Antimicrobial kits and articles

Technical Field

The present invention relates to antimicrobial kits and articles, and more particularly to antimicrobial kits and articles having an antimicrobial agent and a fabric carrier.

Background

Medical infections are a significant issue for global disease management. Surgical site infection, in addition to increasing medical costs and hospital stays, increases the risk of sepsis and death in patients. A 'pioneer research plan for promoting combined care measures to reduce surgical site infection' 2016 research report indicates that the execution rate of preoperative bath measures is low. There are many kinds of microorganisms immobilized on human skin, which are the main sources of infection when a wound is generated on the skin surface. If the skin surface is not completely sterilized, microorganisms in the skin epidermal cell layer can enter the body via medical procedures, invasive medical treatments, or wound treatments, causing medical infections. Therefore, increasing the performance rate of preoperative bathing and enhancing preoperative skin preparation should be one of the ways to effectively reduce the infection rate of the surgical site.

In recent years, as the population is getting older and patients who need special care or long-term care due to the development of special diseases such as aids, uremia, and post-traumatic disease become more and more, the demand for infection control in special care or long-term care facilities is increasing and the work of performing infection control in facilities is also receiving more and more attention. Especially, elderly and ill patients who need long-term care are physically weak, and the risk of the occurrence of "mass infection" of skin-contact infectious diseases and respiratory infectious diseases in institutions is high, so it is important to enhance the monitoring of infections in institutions, infection control and protection measures, and the knowledge ability of caregivers.

In addition, when medical care personnel take clinical medical measures, especially emergency medical measures, such as disinfecting the skin of a patient in an ambulance or an emergency, the medical care personnel often directly immerse a cotton swab and a gauze towel into a disinfectant bottle and wipe the surface of the skin for disinfection. However, in an emergency situation, the operation of the bottle is inconvenient and easy to cause cross infection, and the residual disinfectant after the disinfection operation is finished can not be reused, thereby causing waste of resources.

In view of the above, there is a need in the art for improvements in reducing the risk of infection after invasive medical procedures, enhancing clinical medical emergency measures and infection control in long-term care facilities, and providing effective, adequate and convenient use of disinfectants.

Disclosure of Invention

In order to solve the problems described in the prior art, the present disclosure is directed to an antimicrobial kit and an antimicrobial article for achieving the effects of reducing the risk of infection after invasive medical treatment, enhancing clinical medical emergency measures and infection control in long-term care facilities, and facilitating the effective and proper use of an antimicrobial agent by a user.

The present disclosure provides an antimicrobial kit comprising an antimicrobial agent and a fabric carrier. The antimicrobial agent comprises chlorhexidine gluconate (CHG), and the fabric carrier can carry 0.025mL to 0.075mL (mL/cm) of antimicrobial agent per square centimeter²) The chlorhexidine gluconate is administered topically (topically) at 0.1 to 1.25 milligrams per square centimeter of skin, and the fabric carrier is not pre-loaded with the antimicrobial agent.

In some embodiments, the antimicrobial agent is an aqueous solution of chlorhexidine gluconate in a weight volume percent of 0.1% to 10% (w/v%).

In some embodiments, the antimicrobial agent is packaged in a container made of a material including, but not limited to, Polyethylene (PE), Polyethylene Terephthalate (PET), or combinations thereof.

In some embodiments, the fabric support has a porous mesh structure.

In some embodiments, the fabric support has a thickness of 30 to 100 grams per square meter (g/m)²). In some embodiments, the fabric support has a thickness of 95g/m²。

In some embodiments, the fabric support is square or rectangular.

In some embodiments, the fabric carrier can release the loaded antimicrobial agent to the skin without leaving a residue.

In some embodiments, the material of the fabric carrier includes, but is not limited to, polyester fiber, rayon, or a combination thereof.

In some embodiments, the fabric carrier is one hundred percent polyester fiber and can carry 0.045 to 0.065 milliliters per square centimeter (mL/cm)²) The antimicrobial agent of (1).

The present disclosure further provides an antimicrobial article comprising a fabric carrier, the fabric carrier carrying 0.025 to 0.075 milliliters per square centimeter of antimicrobial agent, the antimicrobial agent comprising chlorhexidine gluconate. Wherein the fabric carrier is for topical administration of 0.1 to 1.25 milligrams of chlorhexidine gluconate per square centimeter of skin.

In some embodiments, the antimicrobial article is packaged in a container made of a material including, but not limited to, polyethylene terephthalate, or combinations thereof.

The present disclosure further provides an antimicrobial article comprising a plurality of fabric carriers, each fabric carrier carrying from 0.025ml to 0.075ml of an antimicrobial agent per square centimeter, the antimicrobial agent comprising chlorhexidine gluconate. Wherein each fabric carrier is for topical administration of 0.1 to 1.25 milligrams of chlorhexidine gluconate per square centimeter of skin.

In some embodiments, each fabric carrier carries 30 milliliters of antimicrobial agent, and the antimicrobial agent is a 2% by weight volume aqueous chlorhexidine gluconate solution.

In some embodiments, the number of the fabric carriers is 8, and the fabric carriers are packaged in a container made of polyethylene.

The present disclosure further provides an antimicrobial article comprising at least one fabric carrier, the at least one fabric carrier carrying 0.025ml to 0.075ml of an antimicrobial agent per square centimeter, the antimicrobial agent comprising chlorhexidine gluconate, wherein the at least one fabric carrier is configured to topically administer 0.1 to 1.25 mg of chlorhexidine gluconate per square centimeter of skin.

In some embodiments, wherein the at least one fabric carrier is soaked with the antimicrobial agent such that the soaked at least one fabric carrier carries 0.025 milliliters to 0.075 milliliters of antimicrobial agent per square centimeter.

In some embodiments, the fabric carrier is made of polyester fibers and carries 0.045 to 0.065 ml of antimicrobial agent per square centimeter.

In some embodiments, eight fabric carriers are included for the shoulder and neck region, chest, arms to palm, legs front, lower abdomen, lower neck to back, legs back, and back waist to buttocks respectively.

In some embodiments, eight fabric carriers are used for sequential use in the shoulder and neck region, chest, arms to palm, legs front side, lower abdomen, lower neck to back, legs back side, and back waist to buttocks.

In some embodiments, the antimicrobial article is used prior to performing an invasive medical procedure.

In some embodiments, the antimicrobial article is used after bathing before performing the invasive medical procedure.

In some embodiments, the antimicrobial article is used once daily on the day and three days prior to the invasive medical procedure.

In some embodiments, the antimicrobial article is adapted to heal after an invasive medical procedure is performed, daily until the invasive medical procedure is performed.

In view of the above, the antimicrobial kits and articles of the present disclosure include an antimicrobial agent comprising chlorhexidine gluconate and a fabric carrier. The antimicrobial kits and articles of the present disclosure provide improved ease of use due to the larger wiping area of the fabric carrier and the ability to use an appropriate amount of antimicrobial agent while still achieving an effective disinfecting amount. In some embodiments, the antimicrobial kit or article comprises eight fabric carriers for use in the shoulder and neck area, chest, arms to palm, legs front, lower abdomen, lower neck to back, legs back, and back waist to hips, respectively, to avoid cross contamination, and to achieve a disinfecting effect. If the antimicrobial kit and antimicrobial article are used for patients who are subjected to invasive medical treatment, the risk of infection after the invasive medical treatment is reduced; if the device is used for patients in special care facilities or long-term care facilities, the risk of infection in the facilities can be reduced, so that infection control in the facilities is enhanced; if used in clinical practice, the antimicrobial agent can be used in an effective and appropriate amount for the user.

Drawings

Fig. 1 shows a schematic view of a fabric carrier of the present disclosure in a skin wiping area on the front of a human body.

Fig. 2 shows a schematic view of the fabric carrier of the present disclosure in a skin-wiping area on the back of a human body.

Description of the reference numerals

10 shoulder and neck region

20 chest

30 double arm to palm

40 front side of both legs

50 lower abdomen part

60 lower neck to back

70 rear side of double legs

80 from waist to hip.

Detailed Description

The above and other embodiments, features and other advantages of the present invention will be more clearly understood by reference to the description and the accompanying drawings.

In order to make the description of the present disclosure more complete and complete, embodiments and examples of the present invention will be described with reference to the accompanying drawings; it is not intended to be the only form in which a particular embodiment of the disclosure may be practiced or utilized. The embodiments disclosed below may be combined with or substituted for one another where appropriate, and additional embodiments may be added to one embodiment without further recitation or description.

As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," "including," and similar language, refer to the stated features, regions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of other features, regions, integers, steps, operations, elements, components, and/or groups thereof.

As used herein, the term "container" is meant to include, but is not limited to, a fixed shape, a non-fixed shape, such as, for example, a pouch, a can, a bottle, or a tube.

The antimicrobial kits of various embodiments of the present invention comprise an antimicrobial agent and a fabric carrier. The antimicrobial agent comprises chlorhexidine gluconate, which may be 0.1% to 10% (w/v) by weight volume of an aqueous solution of chlorhexidine gluconate, preferably 1.6% to 2.4% (w/v) of an aqueous solution of chlorhexidine gluconate, preferably 2% (w/v) of an aqueous solution of chlorhexidine gluconate.

The fabric carrier has a porous network structure, and the pores of the porous network structure can absorb the antimicrobial agent, thereby effectively carrying and carrying the antimicrobial agent and completely releasing the antimicrobial agent carried by the fabric carrier when in use. For example, a fabric carrier having an area of 600 square centimeters can carry from 15 to 45 milliliters of antimicrobial agent, i.e., from 0.025 milliliters to 0.075 milliliters, preferably from 0.045 milliliters to 0.065 milliliters, preferably 0.05 milliliters of antimicrobial agent per square centimeter of fabric carrier for topical administration of from 0.1 to 1.25 milligrams of chlorhexidine gluconate per square centimeter of skin. The thickness of the fabric carrier was 30g/m²To 100g/m²Preferably 95g/m². If the fabric carrier carries less than 0.025mL/cm of chlorhexidine gluconate aqueous solution²The chlorhexidine gluconate aqueous solution released to the skin surface is not enough to achieve the disinfection effect; 0.075mL/cm²The upper limit of the chlorhexidine gluconate aqueous solution which can be carried by the fabric carrier is exceeded, and the chlorhexidine gluconate aqueous solution can drip, so that the operation difficulty is increased.

In one embodiment, the fabric carrier has a size of 20 × 30 cm and can carry 30 ml of antimicrobial agent, wherein the antimicrobial agent is 2% (w/v) chlorhexidine gluconate solution, and the calculated formula of the body surface area is body surface area (square meter) ═ weight (kilogram) × height (cm)/3600 according to the Ministry of health and welfare statistics and the calculation formula of the body surface area^1/2Average body surface area ranging from 5812 square centimeters to 18641 square centimeters can be calculated for 2 years old to adults. If 8 pieces of the fabric carrier are rubbed across the skin, it can be calculated that each piece of the fabric carrier carrying 600 mg chlorhexidine gluconate can be topically administered with 0.25 mg to 0.83 mg of antimicrobial agent per square centimeter of skin.

The invention is not limited to the shape of the fabric carrier, which can be preferably rectangular, including square, rectangular, etc. in some embodiments, the fabric carrier can be designed to be rectangular, such as 20 × 30 cm, when used for large area wiping, the square fabric carrier is easy to curl and is not favorable for large area wiping disinfection, while the rectangular fabric carrier is not easy to curl and is easy to apply force when used for large area wiping disinfection.

The fabric carrier of the invention has a porous reticular structure and thickness, and can protect the skin from excessive physical friction injury during clinical wiping. Thus, in a preferred embodiment, the antimicrobial agent in the antimicrobial kit is a 2% (w/v) aqueous solution of chlorhexidine gluconate, and the antimicrobial agent can remain comfortable to the skin without moisturizing emollient components.

The antimicrobial kit is a combination product in which the fabric carrier and the antimicrobial agent are separately contained in separate compartments and are mixed for use in the same or different packages. The number of fabric carriers in the antimicrobial kit can be one piece of fabric carrier, or a plurality of pieces of fabric carrier. The antimicrobial agent in the antimicrobial kit can be contained in the bottle body, and the bottle body can be made of a material which does not react with chlorhexidine gluconate to generate a precipitation phenomenon, so that the technical effect of the antimicrobial agent is not influenced. The material may be Polyethylene (PE), Polyethylene Terephthalate (PET), or a combination thereof. The polyethylene may comprise high density polyethylene and low density polyethylene. In one embodiment, the antimicrobial kit may include a 2% (w/v) chlorhexidine gluconate aqueous solution contained in the bottle and a fabric carrier contained in the bag. When the fabric carrier is used, the chlorhexidine gluconate aqueous solution is completely poured into the bag body, so that the fabric carrier is soaked in the chlorhexidine gluconate aqueous solution, and the fabric carrier is taken out for use after the fabric carrier bears a sufficient amount of the chlorhexidine gluconate aqueous solution.

The antimicrobial article comprises an antimicrobial agent and a fabric carrier, and is a pre-bonded product, i.e., the fabric carrier is pre-loaded with the antimicrobial agent. Wherein the antimicrobial agent and the fabric carrier are the same as those of the antimicrobial kit described above and will not be described herein again.

In one embodiment, the antimicrobial article is made by diluting 20% (w/v) chlorhexidine gluconate in water to 2% (w/v) with pure water, pouring 2% (w/v) chlorhexidine gluconate in water into a bag containing at least one piece of non-woven fabric, preferably 8 pieces of non-woven fabric, and sealing to obtain the antimicrobial article. The bag body is made of polyethylene, and the polyethylene bag body has good sealing performance, and can not be contacted with the antimicrobial agent for a long time to be reacted with chlorhexidine gluconate to precipitate the antimicrobial agent, so that the effect of the antimicrobial agent is not influenced.

In some embodiments, the antimicrobial kit or article may be applied to the skin prior to performing an invasive medical procedure to reduce the risk of medical infection. Invasive medical treatments may be, for example: a scalpel making, puncture, insertion of a catheter or drain, and the like. Taking a cutting operation as an example: the patient takes out the fabric carrier fully soaked with 2% (w/v) chlorhexidine gluconate water solution from the antimicrobial kit or the antimicrobial product every day to wipe the whole body after bathing the whole body three days before operation to the night before operation; the entire body is again wiped with an antimicrobial kit or article on the day of surgery. After invasive medical treatment, the antimicrobial kit or article may also be wiped systemically or to the site receiving the invasive medical treatment until the site receiving the invasive medical treatment heals.

In one embodiment, the antimicrobial kit or article can be used for skin or appliance cleaning and disinfection without the need for a water rinse after use. For example: patients in intensive care units, long care patients, can be wiped all over the body daily with antimicrobial kits or articles to reduce the risk of nosocomial infections; after receiving the invasive medical treatment, the patient can also be wiped systemically or the affected part receiving the invasive medical treatment by the antimicrobial kit or the antimicrobial product so as to reduce the risk of postoperative infection; in clinical medicine, especially in emergency situations, such as emergency use in ambulances, for disinfection of the skin of a patient with an antimicrobial kit or article, the combination of a package having a plurality of pieces of a fabric carrier impregnated with an aqueous solution containing 2% (w/v) chlorhexidine gluconate is used to achieve the effect of convenience of use and avoidance of waste of antimicrobial agent; medical devices such as catheters may also be sterilized with an antimicrobial kit or article prior to invasive medical treatment.

In one embodiment, the antimicrobial kit or article is used by topically applying the antimicrobial-loaded fabric carrier to the skin to disinfect and sterilize the skin, and the individual fabric carriers are used in zones for single use to prevent cross-contamination. For example: according to the sequence of the eight-step clinical application of the required sterilized parts of the human body, the wiping according to the sequence can avoid the cross infection, the body is divided into eight areas according to the figure 1 and the figure 2, namely, the neck-shoulder part 10, the chest part 20, the arms to the palm 30, the legs front side 40, the lower abdomen part 50 on the front side of the human body, the neck-down part to the back 60, the legs back side 70, the waist-back part to the hip part 80 on the back side of the human body. The chest 20 may also include the chest and the peripheral area of the chest, and the area from the back waist to the hip 80 includes the area from the waist to the back side of the joint between the buttocks and the thighs. When the antimicrobial kit or the antimicrobial product is used, one piece of fabric carrier carrying the antimicrobial agent is respectively used for wiping the skin to be cleaned and disinfected in each of the eight subareas, the sufficient wiping of the antimicrobial agent on the skin is ensured, and the skin is naturally dried after 30 seconds. After the skin is wiped with the microbial agent, the skin can show a glossy feeling, and the skin can be judged to be fully wiped with the microbial agent according to the glossy feeling. In other embodiments, the antimicrobial kit or article may be used in a single application of a single sheet of the antimicrobial-carrying fabric carrier to the topical skin, without limitation.

Although the present invention has been described with reference to the above embodiments, it should be understood that various changes and modifications can be made therein by those skilled in the art without departing from the spirit and scope of the invention.

Claims

1. An antimicrobial kit, comprising:

an antimicrobial agent comprising chlorhexidine gluconate; and

a fabric carrier capable of carrying from 0.025ml to 0.075ml of the antimicrobial agent per square centimeter for topical administration to the skin of from 0.1 to 1.25 milligrams of the chlorhexidine gluconate per square centimeter, and which does not carry the antimicrobial agent beforehand.

2. The antimicrobial kit of claim 1, wherein the antimicrobial agent is 0.1 to 10% by weight/volume chlorhexidine gluconate in water and the antimicrobial agent is packaged in a container made of polyethylene, polyethylene terephthalate or a combination thereof.

3. The antimicrobial kit of claim 1, wherein the fabric carrier comprises polyester fiber, rayon or a combination thereof.

4. An antimicrobial article, comprising:

a fabric carrier carrying 0.025ml to 0.075ml per square centimeter of an antimicrobial agent comprising chlorhexidine gluconate;

wherein the fabric carrier is for topical administration of 0.1 to 1.25 milligrams of the chlorhexidine gluconate per square centimeter of skin.

5. The antimicrobial article of claim 4 wherein the antimicrobial agent is 0.1 to 10% by weight/volume chlorhexidine gluconate in water.

6. The antimicrobial article of claim 4 wherein the fabric carrier has a porous network structure.

7. The antimicrobial article of claim 4 wherein the fabric carrier has a thickness of from 30 to 100 grams per square meter.

8. The antimicrobial article of claim 7 wherein the fabric carrier has a thickness of 95 grams per square meter.

9. The antimicrobial article of claim 4 wherein the fabric carrier is square or rectangular.

10. The antimicrobial article of any one of claims 4 to 9 wherein the fabric carrier expels the antimicrobial agent without leaving the antimicrobial agent in the fabric carrier.

11. The antimicrobial article according to claim 10, wherein the fabric carrier comprises polyester fiber, rayon or a combination thereof.

12. The antimicrobial article of claim 11 wherein the fabric carrier comprises one hundred percent polyester fibers and carries 0.045 to 0.065 ml of antimicrobial agent per square centimeter.

13. The antimicrobial device of claim 4 wherein the antimicrobial device is packaged in a container made of polyethylene, polyethylene terephthalate, or combinations thereof.

14. An antimicrobial article, comprising:

a plurality of fabric carriers, each fabric carrier carrying from 0.025 milliliters to 0.075 milliliters per square centimeter of an antimicrobial agent comprising chlorhexidine gluconate;

wherein each of said fabric carriers is for topical administration of 0.1 to 1.25 milligrams of said chlorhexidine gluconate per square centimeter of skin.

15. The antimicrobial article of claim 14 wherein the fabric carrier comprises one hundred percent polyester fiber and 30 ml antimicrobial agent, and the antimicrobial agent is 2% by weight/volume chlorhexidine gluconate solution.

16. The antimicrobial device of claim 14 wherein the number of said fabric carriers is 8 and the fabric carriers are packaged in a container made of polyethylene.

17. An antimicrobial article, comprising:

at least one fabric carrier carrying 0.025ml to 0.075ml per square centimeter of an antimicrobial agent comprising chlorhexidine gluconate;

wherein the at least one fabric carrier is for topical administration of 0.1 to 1.25 milligrams of the chlorhexidine gluconate per square centimeter of skin.

18. The antimicrobial article of claim 17 wherein the at least one fabric carrier is soaked with the antimicrobial agent such that the at least one soaked fabric carrier carries from 0.025 to 0.075 milliliters of the antimicrobial agent per square centimeter.

19. The antimicrobial article of claim 17 or 18 wherein the fabric carrier comprises one hundred percent polyester fibers and carries 0.045 to 0.065 ml of the antimicrobial agent per square centimeter.

20. The antimicrobial article of claim 17 or 18 comprising eight fabric carriers for the shoulder and neck region, chest region, arms to palm, front side of legs, lower abdomen, lower neck to back, back side of legs, and back waist to buttocks respectively.

21. An antimicrobial article according to claim 17 or 18 which is used prior to the invasive medical procedure.

22. The antimicrobial article of claim 21 which is used after bathing prior to invasive medical treatment.

23. The antimicrobial article of claim 21 which is used once daily on the day and three days prior to the invasive medical procedure.

24. The antimicrobial article of claim 21 which heals after invasive medical treatment and daily use to the site receiving invasive medical treatment.

25. The antimicrobial article of claim 21 comprising eight fabric carriers for the shoulder and neck region, chest, arms to palm, legs front, lower abdomen, lower neck to back, legs back and back waist to buttocks respectively.