Description:FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)
1. Title of the invention: “A BIOFEEDBACK INSTRUMENT FOR PELVIC FLOOR MUSCLE STRENGTHNING”

2. Applicant:
NAME NATIONALITY ADDRESS
1. Marwadi University Indian Marwadi University, Rajkot-Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India
2. Himani
Kishorbhai Dave 5Th Floor, Faculty Of Physiotherapy Main Building, Marwadi University, Rajkot-360003
3. Dr.Ashish Kakkad Professor and Principal, Faculty of Physiotherapy, Marwadi University, Rajkot- Morbi Highway, At Gauridad, Rajkot – 360003, Gujarat, India
3. Preamble to the description
COMPLETE SPECIFICATION
The following specification particularly describes the invention and the manner in which it is to be performed:

Field of the Invention:
The present invention relates to the field of medical devices. More specifically, the present invention relates to develop a biofeedback instrument for pelvic floor muscles strengthening. The present invention related to women’s health physiotherapy.
Background of the Invention:
Women's health has been a topic of concern since ancient times. The female body is more prone to several health issues, especially related to the reproductive system, which can cause severe pain and discomfort. In recent years, physiotherapy has emerged as a safe and effective way to manage and treat many women's health issues, including pelvic floor disorders. Pelvic floor muscles play a critical role in women's health by supporting the bladder, uterus, and rectum, among other organs.
Pelvic floor dysfunction is a common condition affecting women of all ages and backgrounds. Pelvic floor disorders are affecting approximately one in three women worldwide. It occurs when the pelvic floor muscles, which are responsible for supporting organs such as the uterus, bladder, and rectum, become weakened or damaged. These disorders cause a range of problems, including urinary and fecal incontinence, pelvic organ prolapse, and sexual dysfunction. The primary cause of these disorders is the weakening of the pelvic floor muscles, which can be due to several factors such as pregnancy, childbirth, aging, obesity, and surgery. Weak pelvic floor muscles can lead to a range of issues, including urinary incontinence, prolapse, chronic back pain, poor posture, and sexual dysfunction.
Pelvic floor physiotherapy is an effective way to manage and treat pelvic floor disorders. Physiotherapists use a range of techniques such as exercise, biofeedback, and electrical stimulation to help women strengthen their pelvic floor muscles. However, assessing the pelvic floor muscle function can be challenging as it is an internal muscle group, and the patient cannot see the muscle's movement. The current options for treatment, surgery or hormonal therapy, are costly and can lead to complications such as osteoporosis, mood swings, and infertility. Therefore, there is a need for non-invasive, easy-to-handle, and cost-effective therapies for pelvic floor strengthening.
The present invention seeks to provide a non-invasive, affordable, and easy-to-use solution to pelvic floor dysfunction. The biofeedback instrument uses biofeedback technology to measure muscle activity and provide real-time feedback to patients, allowing them to visualize and understand the state of their pelvic floor muscles. This helps patients achieve optimal muscle strength and coordination, leading to improved muscle control, reduced pain and discomfort, and an overall improvement in quality of life.
Object of the Invention:
The main objective of the present invention is to provide a non-invasive and comfortable instrument and method of assessing the function of pelvic floor muscles in patients with pelvic floor dysfunction.
Another objective of the present invention is to provide a versatile instrument that can be used in a variety of settings, including hospitals, clinics, and even at home.
Yet another objective of the present invention is to develop a cost-effective and easy-to-handle instrument that provides feedback to the patient that the pelvic floor contraction has occurred properly.
Yet another objective of the present invention is to help patients achieve optimal muscle strength and coordination by using biofeedback technology to measure muscle activity and provide real-time feedback.
Yet another objective of the present invention is to improve the quality of life for patients suffering from pelvic floor disorders by reducing pain and discomfort and increasing muscle control.
Yet another objective of the present invention is to enhance the effectiveness of other forms of therapy, such as physical therapy, by using pelvic floor biofeedback in conjunction with them.
Yet another objective of the present invention is to provide an affordable, accessible, and effective solution to manage and overcome pelvic floor disorders.
Yet another objective of the present invention is to improve muscle control by using biofeedback, patients can learn to consciously control their pelvic floor muscles, leading to improved muscle tone and strength.
Summary of the Invention:
The present invetion describes a biofeedback instrument for strengthening pelvic floor muscles. The invention relates to a non-invasive and cost-effective pelvic floor biofeedback instrument designed to help patients achieve optimal pelvic floor muscle strength and coordination. The instrument is equipped with a probe (P), cable (C), software, display screen (D), power source, and calibration settings. The probe (P) measures the activity of the pelvic floor muscles and is available in three different sizes for different age groups. The cable (C) connects the probe (P) to the software, which provides real-time feedback on muscle activity. The software is customizable and can store data for later analysis. The display screen (D) provides visual feedback on the strength and coordination of the pelvic floor muscles.
The present invention provides a non-invasive and cost-effective solution for pelvic floor dysfunction by using biofeedback technology to measure and improve pelvic floor muscle strength and coordination. The instrument is equipped with advanced technology and customizable settings, making it an effective and convenient tool for patients to monitor and improve their pelvic floor muscle function.
Brief description of drawing:
Figure 1 shows front view of pelvic floor biofeedback instrument
Nomenclature Part name
H Prob’s handle
P Prob
C Cable
L Light Indiactor
U USB Port
C’ Controls
S On/Off Switch
D Display screen
Figure 2 shows rear view of pelvic floor biofeedback instrument
Figure 3 shows top view of pelvic floor biofeedback instrument
Figure 4 shows bottom view of pelvic floor biofeedback instrument
Figure 5 shows left side view of pelvic floor biofeedback instrument
Figure 6 shows right side view of pelvic floor biofeedback instrument
Detailed Description of the Invention:
The following description relates to a particular manifestation of the present invention. The present invention related to a biofeedback instrument for pelvic floor muscles strengthening. The Pelvic Floor Biofeedback Instrument is a non-invasive device that uses biofeedback technology to measure muscle activity and provide real-time feedback to patients, allowing them to see and understand their progress. It helps patients to achieve optimal muscle strength and coordination, reduce pain and discomfort, and improve their quality of life.
The present invention relates to a pelvic floor biofeedback instrument designed to help patients visualize and understand the state of their pelvic floor muscles to achieve optimal muscle strength and coordination. This pelvic floor biofeedback instrument is an advanced medical device that incorporate sophisticated technology to provide feedback on the strength and coordination of pelvic floor muscles.
The pelvic floor biofeedback instrument is a sophisticated piece of medical equipment that employs cutting-edge technology to aid in the diagnosis and treatment of pelvic floor dysfunction. The instrument is made up of several essential components, including a probe (P), cable (C), software, display (D), power source, and calibration settings. The probe (P) is a key component that is inserted into the vagina and measures the activity of the pelvic floor muscles. The cable connects the probe (P) to the software, which provides real-time feedback on the strength and coordination of the pelvic floor muscles. This software can be customized to the individual patient's needs and can even store data for later analysis.
The display (D) is the interface between the patient and the biofeedback instrument, providing visual feedback on the strength and coordination of the pelvic floor muscles. It is through the display (D) that patients can monitor their progress and make adjustments to their treatment plan accordingly. The power source for the instrument is typically rechargeable batteries, allowing for ease of use and portability. Finally, before the instrument is used, it must be calibrated to ensure accurate readings. Calibration involves setting the baseline for the device and adjusting the software to match the patient's specific needs. The interface of the instrument includes a sensor, software, visual feedback, customizable settings, data recording, and calibration settings.
This pelvic floor biofeedback instrument is equipped with specific technical specifications. The sensor has a thickness of 0.35 mm and a length of 170 mm, with a force measuring range of 20g~10kg or larger. The initial resistance is greater than 10MO and the activation time is less than 0.01S. The instrument can operate in temperatures ranging from -40? to +85? and has a lifespan of more than one million uses. The hysteresis is +10% (RF+ -RF-)/FR+ at 1000g force, and the response time is less than 10ms.
The probe (P) used in the pelvic floor biofeedback instrument in three sizes - small, medium, and large - to suit different age groups, and is made from medical-grade biodegradable material. It is designed to be inserted into the vagina and can measure muscle contractions and relaxation by detecting movement. The cable (C) used in the pelvic floor biofeedback instrument is 3-6 feet in length and typically has a standard USB (U) or audio jack connector. The interface of the pelvic floor biofeedback instrument allows the patient to interact with the device and receive feedback on the strength and coordination of their pelvic floor muscles. The interface typically includes a sensor, software, visual feedback, customizable settings, and data recording.
The interface of this pelvic floor biofeedback instrument is the user interface that allows the patient to interact with the device and receive feedback on the strength and coordination of their pelvic floor muscles. The interface can vary depending on the model and manufacturer, but here are some common features of this device that can be expected:
1. Sensor: The device uses force sensors to sense the force generated by pelvic floor muscles. Force generation capacity of muscle is an indicator of muscle strength. Thus, it will provide data of muscle force generation capacity. The sensor is typically attached over probe (P) and probe (P) is connected with cable (C) that produces data on display (D). The technical specifications for sensor are as below:
• Thickness: 0.35 mm
• Length: 170 mm
• Force Measuring Range: 20g~10kg or larger
• Initial Resistance: >10MO
• Activation Time: <0.01S
• Operating Temperature: -40?~+85?
• Lifespan: >1million times
• Hysteresis: +10% (RF+ -RF-)/FR+,1000g Force
• Response Time: <10ms
2. Software: The software display will typically show a digital representation of the patient's muscle activity. The display (D) may also include visual clues, such as a light indicator (L) which provides lighting after proper contraction of muscles. Software is able to provide various pelvic floor exercise protocols.
3. Visual feedback: This pelvic floor biofeedback instruments include visual feedback, by means of digits to indicate the level of muscle activity. The digit will change according to the tone depending on the level of muscle activity. It also has light indicator (L) to provide visual feedback to patient.
4. Customizable settings: The interface may allow the patient to customize certain settings, such as the size of probe, and exercise protocols.
5. Data recording: The interface may include a feature to record and store data on the patient's muscle activity over time. This data can be used to track progress and adjust treatment plans as needed.
6. Calibration settings: The interface may include a feature to calibrate the device to ensure accurate readings. This may involve setting a baseline for muscle activity or adjusting the sensitivity of the sensor.
Overall, the interface of this pelvic floor biofeedback instrument is designed to be easy to use and provide real-time feedback on the strength and coordination of the pelvic floor muscles. The customizable settings and data recording features allow for individualized treatment plans and progress tracking. Visual feedback can help patients better understand how to properly engage and relax their pelvic floor muscles for optimal results.
The working flow of the instrument begins with the insertion of the probe (P) into the vagina, which is typically made of medical-grade biodegradable material and comes in three different sizes for different age groups. The force sensor attached to the probe (P) detects muscle contractions and relaxation and provides real-time data on the display (D) through the cable (C) connection. The software display shows a digital representation of the patient's muscle activity, which may include visual clues such as a light indicator that provides feedback after proper contraction of muscles.
The patient can customize certain settings such as the size of the probe (P) and exercise protocols according to their needs. The data recording feature enables the device to store and record the patient's muscle activity over time, which can be used to track progress and adjust treatment plans as needed. The calibration settings feature allows the device to be calibrated to ensure accurate readings, which may involve setting a baseline for muscle activity or adjusting the sensitivity of the sensor.
The visual feedback feature helps patients better understand how to properly engage and relax their pelvic floor muscles for optimal results. The customizable settings, data recording, and visual feedback features together make this pelvic floor biofeedback instrument an effective tool for patients to strengthen and coordinate their pelvic floor muscles.
The interface of this pelvic floor biofeedback instrument is designed to be easy to use and provide real-time feedback on the strength and coordination of the pelvic floor muscles. The customizable settings and data recording features allow for individualized treatment plans and progress tracking. Visual feedback can help patients better understand how to properly engage and relax their pelvic floor muscles for optimal results. The software can be customized to suit the needs of the patient and the condition being treated, and the power source is typically a rechargeable lithium-ion battery that lasts for several hours of continuous use. Before use, the instrument is calibrated to ensure accurate readings.
Pelvic floor biofeedback therapy has been shown to be effective in the treatment of pelvic floor dysfunction. It provides immediate feedback to patients, which improves motivation and helps patients maintain correct form during exercises. Additionally, biofeedback has been shown to improve treatment outcomes and reduce the length of treatment compared to traditional exercises alone. This therapy can be used to treat a variety of conditions and is also used in research to study the effects of different types of pelvic floor exercises and treatments.
The Pelvic Floor Biofeedback Instrument is a revolutionary device for the diagnosis and treatment of pelvic floor disorders. It offers numerous advantages and benefits, including improved muscle control, non-invasive therapy, effectiveness, safety, convenience, customization, and compatibility with other forms of therapy. The device is versatile and can be used in hospitals, clinics, and home settings, making it accessible to patients of all ages and backgrounds. Its easy-to-use interface and personalized treatment protocols allow patients to track their progress, set goals, and monitor their exercises.
The instrument's advanced technology utilizes force sensors to detect muscle contractions and provide real-time feedback on the strength and coordination of the pelvic floor muscles. This feedback is crucial in helping patients effectively perform pelvic floor exercises, reducing pain and discomfort, and improving their quality of life. The device is designed to be comfortable and non-invasive, making it a safe and effective option for patients.
The Pelvic Floor Biofeedback Instrument is an essential tool for the diagnosis and treatment of pelvic floor dysfunction. Its advanced technology, personalized treatment protocols, and ease of use make it a game-changer in the field. With the device's numerous benefits and advantages, it is a cost-effective and easy-to-handle solution for patients seeking to improve their pelvic floor muscle strength and coordination.
Main embodiment of the present invention, a biofeedback instrument for pelvic floor muscles strengthening comprising of:
a) a sensor attached to probe (P) to measure the force generated by pelvic floor muscle contraction;
b) a probe (P) made up of medical-grade biodegradable material, inserted into the vagina to measure muscle activity of the pelvic floor muscles;
c) a cable (C) connects the probe (P) to the software;
d) a software provides real-time feedback on the strength and coordination of the pelvic floor muscles and can be customized to the individual patient's needs;
e) a light indicator (L) provides lighting after proper contraction of muscles and visual feedback to patients;
f) a display screen (D) provides visual feedback on the strength and coordination of the pelvic floor muscles and it is the interface between the patient and the biofeedback instrument;
g) a power source is rechargeable batteries; and
h) calibration settings to ensure accurate readings;
wherein said biofeedback instrument is cost-effective and easy-to-handle.
Another embodiment of the present invention, the said sensor is 0.35 mm thick, 170 mm long, 20g~10kg or larger force measuring range, less than 0.01S activation time, >10MO initial resistance, -40?~+85? operating temperature, and <10ms response time.
Another embodiment of the present invention, the said probe (P) is in three different sizes small, medium, and large to cater to patients of different ages.
Another embodiment of the present invention, the said cable (C) is 3-6 feet in length and connected via standard USB or audio jack connector.
Another embodiment of the present invention, the said power source is rechargeable batteries, providing ease of use and portability.
Another embodiment of the present invention, said software provides customized user interface, real-time visual or auditory feedback, data recording and analysis.
This pelvic floor biofeedback instrument is an advanced medical device that incorporate sophisticated technology to provide feedback on the strength and coordination of pelvic floor muscles. The technical details of this instrument given as below:
Probe (P): The probe (P) used in pelvic floor biofeedback instrument is typically made from bio degradable material. It is designed to be inserted into the vagina and measures the activity of the pelvic floor muscles.
• Material: medical-grade biodegradable material
• Size: varies in three sizes small, medium, and large according to different age group
• Placement: inserted into the vagina
• Measurement: detects muscle contractions and relaxation
Cable (C): The probe (P) is connected to a cable (C) that transmits the data from the sensor to the display screen (D). The cable (C) is designed to be flexible and durable to withstand repeated use.
• Length: 3-6 feet in length
• Connector: typically, a standard USB or audio jack connector
Software: The software used in pelvic floor biofeedback instruments is designed to provide real-time feedback on the strength and coordination of the pelvic floor muscles. The software can be customized to suit the needs of the patient and the condition being treated. It can also record and store data for later analysis.
• User interface: customizable to suit the needs of the patient and the condition being treated
• Feedback: provides real-time visual or auditory feedback on the strength and coordination of the pelvic floor muscles
• Data recording: records and stores data for later analysis
• Data will be analysed and according to the strength of patient exercise protocol will be suggested
Display (D): The display (D) is the interface between the patient and the biofeedback instrument. The display (D) provides visual feedback to the patient, indicating the strength and coordination of their pelvic floor muscles.
Power Source: Pelvic floor biofeedback instruments typically use rechargeable batteries as a power source.
• Battery: typically, a rechargeable lithium-ion battery
• Battery life: typically lasts for several hours of continuous use
Calibration: Before use, pelvic floor biofeedback instrument was calibrated to ensure accurate readings. Calibration involves setting the baseline for the device and adjusting the software to match the patient's needs.
• Calibration method: sensor calibration was done by means of standard weights
• Zero / Tare: typically recommended before each use to ensure accurate readings
In conclusion, this pelvic floor biofeedback instrument is highly technical devices that use sensors, cables (C), software, displays (D), and power sources to provide feedback on the strength and coordination of pelvic floor muscles. This instrument plays an essential role in the treatment of pelvic floor dysfunction and can be customized to meet the needs of individual patients. , Claims:We claim,
1. A biofeedback instrument for pelvic floor muscles strengthening comprising of:
a) a sensor attached to probe (P) to measure the force generated by pelvic floor muscle contraction;
b) a probe (P) made up of medical-grade biodegradable material, inserted into the vagina to measure muscle activity of the pelvic floor muscles;
c) a cable (C) connects the probe (P) to the software;
d) a software provides real-time feedback on the strength and coordination of the pelvic floor muscles and can be customized to the individual patient's needs;
e) a light indicator (L) provides lighting after proper contraction of muscles and visual feedback to patients;
f) a display screen (D) provides visual feedback on the strength and coordination of the pelvic floor muscles and it is the interface between the patient and the biofeedback instrument;
g) a power source is rechargeable batteries; and
h) calibration settings to ensure accurate readings;
wherein said biofeedback instrument is cost-effective and easy-to-handle.
2. The biofeedback instrument for pelvic floor muscles strengthening as claimed in claim 1, wherein the said sensor is 0.35 mm thick, 170 mm long, 20g~10kg or larger force measuring range, less than 0.01S activation time, >10MO initial resistance, -40?~+85? operating temperature, and <10ms response time.
3. The biofeedback instrument for pelvic floor muscles strengthening as claimed in claim 1, wherein the said probe (P) is in three different sizes small, medium, and large to cater to patients of different ages.
4. The biofeedback instrument for pelvic floor muscles strengthening as claimed in claim 1, wherein the said cable (C) is 3-6 feet in length and connected via standard USB or audio jack connector.
5. The biofeedback instrument for pelvic floor muscles strengthening as claimed in claim 1, wherein the said power source is rechargeable batteries, providing ease of use and portability.
6. The biofeedback instrument for pelvic floor muscles strengthening as claimed in claim 1, wherein said software provides customized user interface, real-time visual or auditory feedback, data recording and analysis.
Dated 25th April, 2023

ChothaniPritibahenBipinbhai
Reg. No.: IN/PA-3148
For and on behalf of the applicant