A NOVEL DEVICE FOR INSTANT PH DETECTION FIELD OF THE INVENTION:

The present invention relates to a novel device for instant pH detection of any part of the body. The present invention more particularly relates to a novel device for instant pH detection which is easy to operate, cost effective and provide a preliminary diagnosis before opting for more complex and costly methods. The present invention also relates to the method of preparation of said novel device. BACKGROUND OF THE INVENTION:

The pH level of body fluids or other secretions indicates the status of physiological well-being of the subjects in pathological studies. The pH indicator sticks or strips generally containing litmus paper or Bromothymol are available in the market for detection of the pH level of various organic samples including faecal samples to determine acidic or alkaline nature of the samples. The pH level determination is critical for the diagnosis of a number of serious ailments. The pH level misbalance in urine or stool indicates towards various infections or irregularities related to normal bodily functions.

There are a number of factors which can influence the pH level of bodily excretions including sweat, tears, faeces, urine, saliva etc and therefore the body parts where these are produced. Studies indicate that poor absorption of carbohydrates, lactose intolerance, a dysfunctional pancreas, celiac disease or biliary stasis can cause high acidic content while high meat or dairy intake, bacterial infection can cause the bodily excretions to be more alkaline. Age is also an important factor affecting the pH level. For instance, in case of new-borns the pH level of faeces is rather low i.e. acidic.

Different levels of pH in bodily fluids as compared to the norm, indicates different causes and different conditions of regular bodily functions. For instance, the normal pH level of faeces is considered to be 7.0 to 7.5 i.e. slightly alkaline. Currently available methods of pH level testing are based on the analysis of physical samples of stool. Sample of stool is taken directly and kept in a leak proof container. There are a number of precautions to be taken while taking samples. Sample should not be contaminated by urine or water. Samples needed to be analysed within 4 hours of collection unless refrigerated. In few cases multiple samples are required. In paediatric cases sample collection is a rather difficult process. Also the stool analysis results take 1 to 3 days while sometime the instant measurement of pH level is imperative.

Vaginal infections are the most frequent complaints of women of child bearing age seeking gynaecological care. Vaginal pH as a diagnostic marker is very well documented in textbooks like Harrisons' s, Merck Manual and peer reviewed journals (Madhivanan P et al, 2009; Harrison's Principles of Internal Medicine 16th Edition page 766; The Merck Manual of diagnosis & Therapy 18th Edition page 2084). The pH of healthy vagina is acidic with range 3.8-4.5. An elevated vaginal pH > 4.5 indicates infection with bacterial pathogens like Gardnerella vaginalis or protozoal pathogen Trichomonas vaginalis while pH < 4.0 indicates overgrowth of fungal opportunists like Candida leading to vulvovaginal candidiasis. For correct identification of type of vaginal infection, a high vaginal swab is taken for culture or microscopy. Both these methods require time, money and technical expertise. The correct diagnosis of type of vaginal infections needs microscopy and culture-based methods, which poses a challenge in low-resource settings. Present invention allows a quick and straightforward testing method for measuring pH.

Another common gastrointestinal disturbance is lactose intolerance which affects three out of four Indians as per research conducted at Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow (Times of India article dated March 11, 2015). Globally, the gold standard to diagnose milk intolerance is based on ingesting 50 grams of lactose. Alternatively, the subject can be screened with anorectal pH which is acidic in lactose intolerant population (Nyeko R et al, 2010).

In oral diagnostics there is a great challenge to determine biomarkers for screening and evaluating the disease activity. Biomarkers can also serve as a useful tool to measure the efficacy of the therapy. An alkaline pH is associated with increased proteolytic activity of organism and favors the deposition of calcium phosphate, thereby promoting plaque mineralization. This is in accordance to previous studies which suggested that subjects with increased pH have greater remineralization potential for dental plaque (Rajesh KS et al, 2015; Patel RM et al, 2016; Galgut PN, 2001). On the contrary, subjects with decreased salivary mineralization parameters, especially inorganic salivary calcium and phosphate, low salivary pH, reduced salivary flow rate are at a higher risk of developing dental caries as their plaque is more acidogenic and demineralization of enamel occurs more readily (Fiyaz M et al, 2013; Rajesh KS et al, 2015; Singh S et al, 2015). The present invention provides an instant detection of pH in combination with clinical symptoms will provide confirmed diagnosis on the spot.

Largely the methods available for pH detection are mostly complex devices, with high costs and maintenance. The available methods also require trained operators to handle such devices.

There are a number of patents which describes methods for instant pH detection. One such disclosure is the US 3888237 patent which describes a pH-measuring device used in an endoscope. The disclosed device comprises of a tubular member mounted on an endoscope and the said device consisting of a system of electrodes insert able into a body cavity and adapted to contact with matter in said body to indicate a potential corresponding to the pH of said body matter which is to be examined.

US5063930 discloses a device comprising a disposable probe made of a transparent plastic material, including a small pipe with a closed head, a hole provided near the head and one or more pH indicators or other indicators disposed within the probe, for the determination of vaginal pH and other indices. US 5105812 discloses a method and apparatus involving a Nasogastric tube with removable pH detector, the tube and detector are inserted into the patient while monitoring the measured pH of the detector for determining the placement of the tube. Another patent application no. US 11/576130 discloses glove bearing a reporter substance indicating the possible presence of vaginal infections. Said patent application relates to the detection of vaginal fluids and thereby eliminating 50% of the population under scrutiny. Also, said glove is able to detect the bacterial infections only. To obviate the drawbacks in the prior art there is a need for technique wherein the pH detection can be done instantly. The devices for such instant detection should have enough mobility to allow hassle free sample taking and a faster way to analyse the pH level.

OBTECT OF THE INVENTION:

The main object of the present invention is to provide a novel device for instant pH detection in any part of the body.

Another object of the invention is to provide a novel device which is useful for physiological pH detection instantly. Yet another object of the present invention is to provide a novel device for instant pH detection which is easy to operate and provides a preliminary diagnosis before undergoing more complex and costly method of diagnosis or treatment. Yet another object of the present invention is to provide a novel device for instant pH detection which is user friendly, adaptable, convenient, durable and cost effective.

Yet another object of the invention is to check the efficacy of drugs altering the pH in patients.

Yet another object of the invention is to determine the nature and level of a various pathological condition in patients. Yet another object of the present invention is the diagnosis of infection, such as fungal, bacterial, viral or otherwise, lactose intolerance, fat intolerance, celiac disease, pancreatic insufficiency, biliary stasis by monitoring the fluctuating pH level in subjects.

Yet another object of the present invention is to provide a method of preparing novel device for instant pH detection in any part of the body.

SUMMARY OF THE INVENTION:

Accordingly, the present invention provides a novel device for instant pH detection in any part of the body. Said device is capable of providing an accurate determination of the pH of the bodily discharge which helps to provide instant analysis of the sample before proceeding for other extensive and costly diagnostic tests.

The novel device of the present invention is particularly useful for the instant detection of pH of physiological regions with or without insertion of the device. The device is mounted or attached with pH indicator having a wide range of detecting capacity.

The novel device of the present invention is user friendly, cost effective, durable, adaptable, convenient and made of industrially scalable embodiments, comprising of chemically inert, flexible and durable material.

The novel device of the present invention provides a preliminary diagnosis before opting for more complex and costly methods of diagnosis or treatment. The present invention also discloses the method of preparation of said novel device for instant, accurate determination of the pH of the bodily discharge from any part of the body. One of the important aspects of the novel device of the present invention is its ability to detect levels of pH with utmost accuracy and to determine the nature of an infection, whether fungal, bacterial or viral with the help of various indicators used in the device. Said device is also helpful to determine the efficacy of the ingested drugs as the intake of drugs such as rifamixin, lactulose or probiotics tend to alter the pH in the patient with hepatic encephalopathy. The pH of the bodily discharge is also altered during infection, in conditions such as lactose intolerance, fat intolerance, celiac disease, pancreatic insufficiency, biliary stasis etc. The novel device of the present invention is capable of being used in the privacy of home, by subjects themselves, without any specific training or expert supervision. Cost effectiveness of the invention makes it suitable for regular use for preventive diagnosis. BRIEF DESCRIPTION OF DRAWINGS:

Figure 1 depicts the image of the device

Figure 2 depicts the instructions of use.

Figure 3 depicts reading of pH values in different indications across

representative body sites.

DETAILED DESCRIPTION OF INVENTION:

Accordingly, the present invention provides a novel device (10) for instant pH detection in any part of the body. Said device (10) is capable of providing an accurate determination of the pH of the bodily discharge which helps to provide instant analysis of the sample before proceeding for other extensive and costly diagnostic tests.

Said device (10) is used to determine pH of any body part with or without insertion. The check on the range of pH of a given body part is performed to determine the possibilities of any illness or malfunction in the body. These could occur due to malfunction in the systems including the circulatory and digestive systems or due to the presence of infectious pathogens in the body especially in the initial stages when there are no visible symptoms. The present invention enables the detection of such malfunction or infection at an early stage thereby allowing for the early detection and treatment to mitigate or contain the problem.

According to the present invention, the device (10) comprises of first means (11) for pH detection and second means (13) for sample collection. When the second means (13) is brought in contact with first means (11) the pH is recorded and analyzed with pH guiding chart to analyze the nature and level of pathological conditions. Said device is in the form of an examination device with beaded cuff. Device (10) is made of natural rubber latex/ nitrile/ Vinyl/ HDPE material and coated with polymer on the inside to facilitate easy donning of said device (10). Said device has a trim look from outside. The first means (11) of this device has a highly specific pH paper/ pH indicator (12) for pH detection while the second means (13) has absorbing gauze (14) for collection of body fluid as shown in Figure 1.

More particularly but not limited, said device (10) is a glove with beaded cuff to be worn in the hand. Made of natural rubber latex/ Nitrile/ Vinyl/ HDPE material, and coated with polymer the device is so worn so as to don the first means (11) of this device having the highly specific pH paper/ indicator (12) for pH detection on the thumb while the second means (13) having the absorbing gauze (14) for collection of body fluid would be worn on the index finger, as shown in Figure 1.

The present invention provides a means of measuring the pH of the bodily discharge in an easy and painless manner that allows self-diagnosis by the subject on their body in privacy without special training or expert supervision for preliminary screening before undergoing more complex and costly method of diagnosis or treatment. The present device (10) is capable of detecting the pH of the sample within the range of 3.5-8.0. Along with the present device (10), a color chart is provided enables the subject to read the color of the pH indicator by correlating with the enclosed color chart. In addition, a comparative sheet is provided to enable the subject to ascertain the nature and level of the pathological condition.

Before the preferred embodiment of the present invention is described, it is understood that this invention is not limited to the particular materials described, as they may vary. It is also understood that the terminology used herein is for the purpose of describing the particular embodiment only and is not intended to limit the scope of the invention in any way. It must be noted that as used herein, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

Following are the steps involved in the detection of the pH by the device: The hands are washed and dried before performing the test. The device is in the form of a latex/ nitrile/ Vinyl/ HDPE examination glove and is worn in the hand. The index finger is inserted in the body orifice where the analysis is to be done for 5-10 seconds such as the anus, vagina or mouth. The device of the present invention can also be used in a manner that body fluids emanating from any of the body orifices are merely touched so that it is collected on the index finger without insertion into the said body orifices. After the sample is collected, the index finger is pressed against the pH indicator on the thumb for 5 seconds as shown in Figure 2. Then the fingers are opened, and the color of the pH indicator is correlated with the color chart provided along with the pack.

This change in color of pH indicator is then analyzed with the comparative sheet as provide with the device to ascertain the level of infection.

The device of the present invention is a simple and cost-effective tool for diagnosis of a multitude of pathologies. The present invention provides a method of preparing pH detection device. In one of the preferred embodiment, the present device is prepared under GMP conditions with Acceptable Quality Limit (AQL) 1.5.

Once the powder free glove is ready, the orientation is fixed to index finger and pH paper is affixed to thumb with a special tape to prevent reaction of the glove with pH paper. The absorbing gauze (14) is also affixed with tape on the tip of index finger as shown in Figure 1. The glove (10) is finally folded from the cuff and packed in individual pouch to prevent the reaction of pH paper with humidity and other reactants in the surroundings.

The device is kept at cool and dry place away from direct sunlight with temperature preferably in the range of 10°C to 40°C.

NON-LIMITING EXPERIMENTAL DETAILS:

Detection of Anorectal pH

The association between colorectal cancer (CRC) and intestinal microbiota has been studied for many years. The decrease in counts of microbiota (particularly obligate anaerobes) leads to changes in the intestinal environment, which may ultimately lead to the development of CRC. In a study by Ohigashi et al (2013), CRC patients showed significant differences in the intestinal environment, including alterations of microbiota, decreased short-chain fatty acids (SCFAs), and elevated pH. Measuring anorectal pH therefore serves a quick and point of care device for screening subjects with intestinal dysbiosis posing risk for colorectal cancer. To validate this hypothesis, the present study is conducted where anorectal pH is checked with test glove with pH indicator in subjects with colorectal cancer and compared with healthy subjects. The anal pH of subjects with colorectal cancer is more alkaline due to altered microflora and thereby decrease in organic acids (Table 1).

The present study confirms the fact that anorectal pH is more acidic in lactose-intolerant subjects compared with healthy controls as shown in

Table 1.

Table V. Anorectal pH in healthy controls, subjects with colorectal cancer and with lactose intolerance Silo of Subject Moan pi I +

Sludv Population pi I

examination No. SI )

001 6.5

002 7.0

003 7.0

Healthy Controls

004 7.5 6.86 ± 0.34 (N=7)

005 7.0

006 6.5

007 6.5

001 5.5

Anus 002 6.0

Lactose intolerant

003 5.5 5.80 ± 0.24 (N=5)

004 6.0

005 6.0

001 7.5

002 7.5

Colorectal cancer

003 7.0 7.40 ± 0.20 (N=5)

004 7.5

005 7.5

Detection of Vaginal pH

The present invention is an inexpensive screening tool which when combined with WHO syndromic approach gives confirmed diagnosis within OPD. It helps to identify such common infections as bacterial vaginosis and vulvovaginal candidiasis. The present study confirms the fact that healthy vaginal pH is in the range of 4.0-4.5 while in subjects with Bacterial vaginosis (BV), it elevates the pH to > 4.5 and in subjects with candidiasis the pH falls in the range of 3.5-4.0 (Table 2).

Table 2: Vaginal pH in healthy controls, subjects with Bacterial vaginosis (BV) and Candidiasis (N=8) 002 4.0

003 4.0

004 4.0

005 4.5

006 4.0

007 4.5

008 4.0

001 5.5

002 6.0

003 5.0

004 5.5

Bacterial Vaginosis

005 6.0 5.55 ± 0.37 (N=9)

006 6.0

007 5.5

008 5.5

009 5.0

001 4.0

002 3.5

003 3.5

Vulvovaginal 004 3.5

3.62 ± 0.22 candidiasis (N=8) 005 3.5

006 3.5

007 4.0

008 3.5

Detection of Salivary pH

The experiments of the present study reveal that pH of saliva is more alkaline in subjects with chronic gingivitis and periodontitis as compared to healthy controls when checked with test glove with pH indicator. The present study reported that the salivary pH in subjects with dental caries is more acidic when compared with healthy controls and subjects with chronic gingivitis & periodontitis (Table 3). Table 3: Salivary pH in healthy controls, dental caries and subjects with chronic gingivitis

Silo of Sub jo I Moan pl l ±

Study Population pH

examination No. sn

001 7.0

002 6.5

003 7.5

Healthy Controls

004 7.0 6.93 ± 0.32 (N=7)

005 7.0

006 7.0

007 6.5

001 7.5

Chronic

Saliva 002 7.5

gingivitis/

003 8.0 7.60 ± 0.20 Periodontitis

004 7.5

(N=5)

005 7.5

001 6.5

002 6.0

Dental caries

003 6.0 6.20 ± 0.24 (N=5)

004 6.0

005 6.5

Accordingly, the present invention would be of great help in screening and diagnosis of a multitude of pathologies associated with change in microbiota resulting in change of body pH at various sites like anus, vagina and mouth (Table 4). Table 4: Body pH from different sites with different pathologies and healthy controls

Silo of Study I'opiilalion N umber of Mean pi 1 examination subjects

Bacterial Vaginosis 9 5.55 ± 0.37

Vulvovaginal 8 3.62 ± 0.22 Candidiasis

Mouth/ Saliva Healthy controls 7 6.93 ± 0.32

Dental caries 5 6.20 ± 0.24

Chronic 5 7.60 ± 0.20

Gingivitis/

Periodontitis