WO2023009040A1

WO2023009040A1 - Automatic surgical hand sanitizer device and method of use

Info

Publication number: WO2023009040A1
Application number: PCT/SA2021/050021
Authority: WO
Inventors: Abdulaziz ALNASSAR
Original assignee: Alnassar Abdulaziz
Priority date: 2021-07-27
Filing date: 2021-11-19
Publication date: 2023-02-02

Abstract

The current invention generally relates to a device used for sterilization of the surface of the arm and hand to achieve reduction in the risk of spreading infections within the healthcare setting, specifically used by hospital staff participating in the operating room which require pre-operative surgical hand sanitization. The current device can efficiently sterilize the targeted area automatically in under 10 seconds using harmless bactericidal ultraviolet light directed to the user's arm, eliminating and reducing microbes by approximately 99.9%. The current invention consists of a tripod portable device with two arm inputs containing a sterilizing light source of FAR-UVC light with a wavelength of 220-220nm aimed to achieve optimal sterilization in a safe and effective manner, potentially providing benefits over the currently available and used methods such as reducing the costs of high-water consumption and disinfecting soaps and towels.

Description

Title: Automatic Surgical Hand Sanitizer Device and method of use

Technical field: the current invention generally relates to a device used for sterilization of surfaces to achieve reduction in the risk of spreading infections, more specifically, a hand sanitizer device, such as for use in the surgical healthcare setting, that can sanitize the surface of the forearm and hand, e.g., Pre operation surgical hand scrub, achieved by directing bactericidal ultraviolet light leading to death or inactivation of harmful microorganisms without harming the user, thereby reducing the risk of spreading infections including Surgical Site infections (SSI).

Background:

In the past years, healthcare-acquired (HAI's) infections have become a growing concern. In particular, many patients admitted to the hospital already witness some type of weakened immunity specifically due to illness, making them more vulnerable to get infected and witness a course of infectious disease. Contracting a HAI in patients admitted to the hospital is widely observed throughout the year resulting in some cases of mortality. Surgical site infections (SSI's) are known to occur when microorganisms such as bacteria transfer to the patients wound site during surgery, resulting in an infected wound. SSIs are one of the most common forms of HAI in surgical patients, its estimated that approximately 1 in 20 surgical patients develop a SSI. SSIs remain an issue to both the patient's life and healthcare system, resulting in delayed wound healing, increased hospital stays and usage of antibiotics, and in severe cases maybe death, thus, preventing its occurrence is vital for health services. The Prevention of SSIs takes place in many ways. This includes antiseptic cleansing of the hands for those operating on the patient aiming to eliminate and reduce microorganisms. The Process of SHD generally takes nearly 3-5 minutes to complete. Surgical hand disinfection mainly occurs by using different techniques, either antiseptic soap which is traditionally used or the use of alcohol-based hand rub which has evolved lately resulting in less water and time consumption and costs of surgical soaps. However, water waste of nearly 4.5- 15L in a single session per OR per year and costly scrub soaps and alcohol solutions (which could lead to stings in breached skin or rarely skin reactions, along with using towels to dry post-scrub remain an issue. Leading to an increase in costs on the hospital. Patients with emergency conditions sometimes require immediate surgical intervention, which could be delayed due to the traditional surgical hand scrub time. Required urgent and

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SUBSTITUTE SHEETS (RULE 26) Immediate care of the patient without proper sanitization is also an issue, which could result in an SSI. Given the frequency of how often this procedure takes place on a daily basis, both water waste and costs of antiseptic products remain an issue. Another method for sanitizing surfaces includes using an ultraviolet surface sterilizer to sterilize the surface of objects in a surgical room. With this method, the time required to sterilize objects within the room is calculated by factoring in the distance from the UV light source to the targeted surface or object. Flowever, the application of FAR UV-C light on hand sterilization, specifically in the surgical setting pre op, has not yet been applied. Furthermore, there is a chance of incomplete sterilization of an object within the surgical setting due to crowding of some objects. Finally, UVSS machines can be very expensive costing up to $100,000 per unit. In another example, handheld UV wands have been used to sterilize the surfaces of certain objects e.g., surgical instruments. Operated by UV-C lights. Flowever, there is a concern in some UV-C exposure to users because UV-C radiation can be damaging to human eyes and skin. It thus would be beneficial to provide a safe device and method for pre-operating surgical hand sanitizing, that can reduce the risk of spreading infectious diseases within the surgical healthcare setting and that can be easily and safely used and can be less costly and time consuming than other currently available methods and devices.

Brief Description:

The hand sanitizer device can sanitize and target the region involved in the process of presurgical hand sanitization within the healthcare setting specifically (Surgical hand scrub) involving the sanitization from elbow to hand without the introduction of water. Sanitization occurs by directing germicidal ultraviolet light to kill and inactivate harmful microorganisms that can cause infectious disease, thus, reducing the risk of potential infectious spread e.g., SSI. The utilization of Far-UVC light specifically can kill and inactivate microorganisms such as bacteria, molds, yeasts, protozoa and viruses on the surface of the targeted human tissue safely without producing any harm or damage against the user during the process of presurgical hand scrub in the hospital, eliminating up to 99% or more of surface microbes, such as those that can cause and lead to consequences of infectious spread (SSI). The Far-UVC light can emit radiation containing a wavelength of 220 nm-222 nm, which has recently shown to be harmless to human tissue. The device can sanitize both hands simultaneously targeting the portions needed and affecting the whole surfaces of the hands to fulfill optimal surgical hand scrub technique. The surgical hand sanitizer device can allow the hand to be automatically cleaned in place without personal intervention in seconds, which can be safe and easier to use and less costly and time consuming than other currently available methods used within the healthcare setting, preventing the huge waste in water and

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SUBSTITUTE SHEETS (RULE 26) costs of surgical scrub soaps and reactions against the skin caused by the soaps to some individuals, in addition to the reduction of costs due to towels needed for drying post scrub.

Brief description of figures and drawings:

Figure (1): Shows the base of the tripod device with wheels and 2 pedals, one controlling manual termination of the sterilization process and the other for height adjustment.

Figure (2): A frontal view of the device.

Figure (3): Shows the core of the device which contains FAR-UVC sterilizing light emitting lamps, along with the elbow support in which the arm lies in.

Figure (4): Shows an angle view of the whole device.

Figure (5): Shows the control panel which provides the user with the device status.

Detailed description:

Described herein generally is a device that can eliminate microorganisms on the human tissue pre-op during Surgical hand Sterilization to prevent chances of infection. The device is utilized for sterilization of the surface of the arm specifically from hand to elbow. Sterilization of the arm pre-op which is needed by the surgeon and staff within the operating field can be somewhat time and cost consuming. The typical Surgical hand Sterilization method requires approximately 3-5 minutes associated with high water consumption leading to high costs. Sterilization using the described portable device can reduce the burden of time and cost. Surgical site infections (SSIs) are serious complications occurring in healthcare. As the surgical site is a main entry gate for organisms located within the surrounding environment, posing a serious threat to the human body along with infections. The preoperative Surgical hand sanitization phase is crucial for performing safe surgery, in which the primary goal is to eliminate and reduce any infectious organisms surrounding the surgical site. As recommended and previously described by the World Health Organization (WHO) along with several studies, the appropriate surgical hand scrub technique advises for scrubbing the arm for at least 3-5 minutes using a disinfectant soap and water in order to properly sterilize the area. Due to situations of time constraint, such as in an emergency

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SUBSTITUTE SHEETS (RULE 26) procedure requiring urgent intervention, delivering care with the typical surgical hand scrub method could negatively impact patient care by several ways, 1- in which urgent intervention could slightly be delayed due to the 3-5-minute scrub procedure, 2- the possibility of Inadequate sterilization due to the rush in time-critical emergency situations which could ultimately lead to a healthcare acquired infection (HAI). Thus, hospitals and participants within the medical field are in need of an efficient time and cost saving device used for preoperative disinfection. The present device can sterilize the arm e.g., Pre operation surgical hand scrub efficiently in a more quicker and cost reductive method than the present available standards using FAR-UVC light with a wavelength of ~220-222nm. The present device can deliver benefits within the clinical setting that enhance provider efficiency, in addition to improving clinical outcomes while substantially saving costs. The present device can be built on a stable/portable platform delivering complete sterilization with approximately 99.9% (log 3) microbial reduction without the need of soap and water consumption within seconds. The described device reduces organisms by approximately 99.9% including: SARS-CoV-2, methicillin-resistant Staphylococcus aureus (MRSA), Escherichia coli bacteria, pseudomonas aeruginosa, the fungus Aspergillus niger, and the yeast Rhodotorula mucilaginosa. The device described can be used to sterilize the surface of the arm and hand by hospital staff such as surgeons and nurses or any participant within the healthcare setting. The device when used by an operator, the device can achieve optimal safety and quality standards provided by local regulations and protocols. The Set standards for preoperative surgical scrubbing involves disinfecting the hand to elbow with chlorhexidine-alcohol or povidone-iodine soaps along with water for 3-5 minutes. The device described herein can reduce the time of sterilization compared to the set standard sterilization process. The described device can sterilize the targeted area for preoperative surgical scrubbing in less than 10 seconds or about less than 5 seconds. Thus, the present described sterilization device can save time when sterilizing. One embodiment of the device described includes a body. The body can be designed to be portable with wheels, or stable onto a wall with a wall mount. The body can be formed of materials such as aluminum. In other embodiments, the body can be formed of polymers such as TOPAS, which can enhance Ultraviolet (UV) transmission. The body can include an on/off button. The button can be a switch to push or press for activation. In other embodiments, the device can activate automatically in where the device begins the sterilization process as soon as the user is detected. In some embodiments, the device can have one or more sensors located anywhere on the device. In some embodiments, the one or more sensors can be configured to operate and begin the sterilization process once the sensors detect the input of the user. The described device can include one or more light indicators. The indicator lights on the body can provide a series of light colors used to indicate device status. In some embodiments, green light can indicate successful sterilization and red light can indicate unsuccessful sterilization and blue light can indicate that sterilization is in process. The body can accommodate a power source. In some

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SUBSTITUTE SHEETS (RULE 26) embodiments, the body can have at least one power source. The power source of the device can be a plug connected to the wall or it can be a battery or a combination of both. The described device can be reusable, allowing a single device to sterilize more than once. In some embodiments, the device can be disposable with disposable material after any number of uses. The described device can be sterilizable using sterilization techniques without damaging the device using detergents or alcohol-based products. The described device can automatically shut down when battery is low and insufficient in producing enough energy to complete sterilization. The device can include a processor which can store memory and instructions including the number of sterilizations, light sensitivity, and sensor inputs and outputs. The device described can contain a light source for sterilization. The light source can be ultraviolet light, specifically emitting FAR-UVC light targeting the surface area. In some embodiments, the Ultraviolet light source can be a bulb. In another embodiment, the light source can be designed as thin strips of Ultraviolet light emitting source. In other embodiments, the light source can be anything that will emit Far Ultraviolet C light. In some embodiments, FAR-UVC light can be delivered with a wavelength ranging from 220-222nm. In some embodiments, FAR-UVC light can be delivered for about 10 seconds or less reaching about 5 seconds. The described light source can reduce and eliminate any microorganisms on the targeted surface. The device described is designed to be portable, formed as tripod stand base containing three wheels for transportation. The wheels of the described device can contain wheel locks for ground support and stabilization. The device described contains 2 extensions projecting from the tripod stand. The extensions comprise of the functional part of the device in which the sterilization process occurs. The described device is designed to accommodate the arm specifically from hand to elbow e.g., Pre operation surgical hand scrub. The described device is somewhat cylindrical in shape with a spherical proximal top. The core of the described device is covered by an upper and lower shell-like structure functioning as an automatically sliding door for user arm input upon starting the sterilization process and output upon finishing. In this device, only the upper cover slides when starting and ending the sterilization process, functioning as a door. The door closing upon using the device is functioned by sensing the users arm input through sensors and opens when detecting the end of sterilization. The sensors used to function the device could be laser sensors or any other type of sensors. The described device's core contains thin FAR-UVC emitting excimer lamps distributed in a 360^° form to target the whole surface required for sterilization. In another embodiment, reflective material could be added to the inside of the device which could reflect the UV light and increase its intensity. The targeted area for sterilization in this device is from hand to elbow which is needed for preoperative surgical hand sanitization. The distal part of the described device contains a socket in which the elbow is placed for elbow support upon beginning the sterilization process. The base of the socket designed for elbow support is made from closed cell foam material which provides comfort. The socket can be made of any material. The

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SUBSTITUTE SHEETS (RULE 26) described device contains a control panel in the center, the control panel contains the light indicators to provide the user with the device status. In another embodiment, the control panel can contain a screen which provides feedback to the user. The base of the described device contains two separate pedals, one which terminates the sterilization process and opens the upper cover manually for any reason, and the other for height adjustment.

Example of device use and method:

Before entering the operation room, the surgeon or hospital staff must proceed with pre-operative hand disinfection, this described device is available for this purpose. This device will be portable for easy accessibility. The Healthcare provider or user approaches the functioning device with the cover open and ready for sterilization. The user then can adjust the devices height if needed by pressing the buttons located on the central control panel, then inserts their arm into the device in a slightly horizontal position while the elbow is supported by the socket-like structure provided for elbow support, the sensor then detects the users input and automatically closes the cover in a sliding matter to begin the sterilization process. After arm insertion and cover closing, the device will start the sterilization process by powering the FAR-UVC excimer lamps targeting the whole surface area needed for sterilization. During this process, the device signals the user about the device status provided by the light indicators on the central control panel, in which green indicates successful sterilization, blue indicates in-process of sterilization, and red indicating failure of sterilization. Upon completing sterilization, the cover opens automatically, and the user can then proceed to the operating room sterile. The pedal located at the base of the device can also be used to open the device cover and terminate the sterilization process manually by easily pressing on it.

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SUBSTITUTE SHEETS (RULE 26)

Claims

Claims:

1- An automatically used sterilization device and body comprised of at least one power source.

2- The sterilization device in a tripod stand base design, containing 3 legs with wheels for easy movement, and the wheels containing locks for ground support.

3- The sterilization device with an upper part comprised of 2 projections in which represent the functioning part of the sterilization device for each arm.

4- The sterilization device containing a cover for both arms upon beginning sterilization.

5- The sterilization device cover opens and closes automatically using sensors which could be laser sensors or any other type of sensors.

6- The sterilization cover functions in a sliding matter.

7- The sterilization device containing one or more sensors distributed anywhere in the device, sensing the users input and output and activating the device.

8- A Sterilization device, wherein the device contains at least one light source such as excimer lamps.

9- A Sterilization device, wherein the at least one light source emits ultraviolet light.

10- A Sterilization device, wherein the at least one light source emits Far ultraviolet C (FAR-UVC) light.

11- A Sterilization device, wherein the at least one light source has a wavelength of 220-220nm.

12- A Sterilization device, wherein the light source for sterilization is distributed in a 360^° form to target all surface areas.

13- The sterilization device, wherein the sterilization process takes about 5 seconds.

14- The sterilization device, wherein the sterilization process takes less than 10 seconds.

15- The sterilization device, wherein elimination and reduction of microbes is about 99.9%.

16- The sterilization device, wherein the device contains a control panel with at least one light indicator.

17- The sterilization device, wherein the indicator lights on the control panel provide colors for device status.

18- The sterilization device, wherein the colors for device status are green for successful, blue for in- process, and red for unsuccessful sterilization.

19- The sterilization device, wherein the control panel contains a screen for feedback.

20- The sterilization device, wherein the device contains a pedal for height adjustment.

21- The sterilization device, wherein the device contains a socket-like structure for elbow support.

22- The sterilization device, wherein the device contains a pedal at the base for terminating the sterilization process manually.

23- The sterilization device, wherein the device contains a switch for power on and off.

24- A Method of use, wherein the method is inserting both arms into the sterilization device to apply sterilizing light onto the surface of the targeted areas.

25- The method of use, wherein the applied sterilizing light is ultraviolet light.

26- The method of use, wherein the ultraviolet sterilizing light used is Far ultraviolet C light (FAR- UVC) light.

27- The method of use, wherein the sterilizing light has a wavelength of 220-222nm.