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A LOW-PRESSURE DIALYSIS ACCESS BAND

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A LOW-PRESSURE DIALYSIS ACCESS BAND

ORDINARY APPLICATION

Published

date

Filed on 7 November 2024

Abstract

The present invention discloses a low-pressure dialysis access band (100) configured to regulate compression at vascular access sites during dialysis, reducing complications like stenosis and thrombosis. The device includes a pressure-regulating mechanism (5), one or more sensors (10) to monitor blood flow and pressure, and a feedback system (15) for real-time adjustments. Constructed from flexible, hypoallergenic materials, it provides continuous monitoring and dynamic response, enhancing patient comfort, promoting vascular health, and reducing the need for invasive corrective procedures.

Patent Information

Application ID202411085713
Invention FieldBIO-MEDICAL ENGINEERING
Date of Application07/11/2024
Publication Number47/2024

Inventors

NameAddressCountryNationality
Dr. AKSHAYA UPASHYAYDepartment of Urology, Graphic Era Institute of Medical Sciences, Graphic Era deemed to be University, Dehradun.IndiaIndia
VANDANA RAWATDepartment of Computer Science & Engineering, Graphic Era deemed to be University, Dehradun.IndiaIndia

Applicants

NameAddressCountryNationality
GRAPHIC ERA DEEMED TO BE UNIVERSITY566/6, Bell Road, Society Area, Clement Town, Dehradun – 248002, Uttarakhand, India.IndiaIndia

Specification

Description:FIELD OF THE INVENTION:
The field of the present invention relates to medical diagnostic tools, specifically urine-based testing devices for kidney function monitoring. It involves a disposable dipstick configured to track essential biomarkers indicative of kidney health, offering a convenient, non-invasive solution for real-time kidney function assessment.

BACKGROUD OF THE INVENTION:
Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
Dialysis is a life-sustaining treatment for patients with chronic kidney disease or end-stage renal failure. By simulating some of the kidney's natural functions, dialysis helps remove waste products and excess fluids from the blood. While essential, the procedure has limitations and complications that stem largely from the vascular access methods used. Most dialysis patients rely on an arteriovenous (AV) fistula or graft as a permanent access point. However, maintaining these access points is challenging, given the repetitive high-pressure stresses placed on blood vessels, which are not configured for sustained and repeated access at high pressures. As a result, dialysis patients often experience complications such as stenosis, thrombosis, and aneurysm formation at access sites, impacting the longevity and effectiveness of the treatment.
Dialysis access points endure substantial pressure fluctuations during each session. Repeated sessions lead to a chronic cycle of vascular trauma, as blood flow is increased through the access site to achieve the efficiency needed for adequate filtration. Over time, the continuous pressure and puncturing cause vessel walls to weaken, thickening the tissue and narrowing the lumen in a process called stenosis. This condition hinders the blood flow, requiring additional medical interventions to maintain the functionality of the access site. Unfortunately, stenosis and other vascular access complications account for a significant portion of dialysis-related hospitalizations and medical costs.
The current methods to address these complications are limited, and the options are primarily reactive rather than preventive. Surgical interventions, such as angioplasty or stenting, are often needed to correct stenosis and other access complications. However, these procedures are invasive, carry risks, and are not always successful long-term. In addition, the options available for vascular access are finite. When an AV fistula or graft becomes unviable, alternative access points need to be created, often in less optimal anatomical locations, further complicating treatment and patient outcomes. Preventing excessive pressure on these access sites could significantly reduce the need for such invasive procedures, extending the lifespan of access points and reducing patient morbidity.
In recent years, attention has turned toward the development of devices and techniques to protect vascular access sites. These approaches seek to modulate the forces exerted on blood vessels during dialysis, specifically focusing on limiting the pressures applied to access points. However, existing solutions, such as conventional compression bands, do not provide adequate control over pressure application. These bands lack the precision needed to monitor or adjust to individual patient needs, creating potential risks of either over-compression, which may lead to ischemia, or under-compression, which may fail to protect the access site. Moreover, most of these devices rely on static designs that cannot respond to the dynamic changes in blood flow and pressure experienced during dialysis.
Additionally, the patient experience is significantly impacted by vascular access complications. Pain, swelling, and discomfort are common, as are the anxiety and inconvenience associated with frequent medical interventions to manage complications. The need for a solution that reduces these issues while promoting long-term access site health is pressing. A device that can actively maintain an optimal low-pressure environment at the access site would be a valuable tool in dialysis care, potentially lowering the incidence of vascular trauma and the subsequent need for corrective procedures. Such an innovation would represent a shift from reactive to proactive care, offering patients a better quality of life and healthcare providers a means of reducing the operational costs associated with repeated interventions.
Current research and advancements in materials science and wearable medical technology provide promising avenues for creating a low-pressure dialysis access band. With recent developments in flexible, biocompatible materials, it is now possible to design devices that conform comfortably to the patient's body while offering enhanced durability. Incorporating pressure-sensing technology within the band could allow for continuous monitoring, providing real-time feedback and adjustment capabilities to prevent excess pressure on the access site. Moreover, integrating these sensors with micro-adjustment mechanisms, which can modify the compression levels dynamically, would further improve the protection of the vascular access site during dialysis.
Such a device would also address significant unmet needs in dialysis care. Patients could benefit from an access band that offers individualized pressure modulation based on real-time data, accommodating the variability in blood flow and pressure that occurs during treatment. Additionally, this personalized approach could be crucial for patients with different physiological needs, including those with fragile vascular systems. Through consistent monitoring and adjustable pressure application, a low-pressure dialysis access band could not only extend the functional lifespan of vascular access sites but also reduce the overall incidence of access-related complications.
The healthcare system could see substantial benefits from such an advancement. Reducing vascular complications directly translates to fewer hospital visits, minimized need for corrective surgeries, and lower healthcare costs overall. For healthcare providers, this improvement could streamline patient management, decrease the frequency of access failures, and enhance the overall efficiency of dialysis centers. By decreasing the frequency of costly interventions, a preventive device such as a low-pressure access band could alleviate the resource strain associated with managing access-related complications.
Therefore, the development of a low-pressure dialysis access band addresses a critical need within dialysis care. It seeks to mitigate the risks associated with traditional access methods by providing a controlled, low-pressure environment that protects vascular access sites from the chronic trauma induced by repeated high-pressure applications. With its potential to minimize complications and improve patient comfort, such a device would represent a major advancement in dialysis care, aligning with modern trends toward personalized and preventive medicine. By enhancing both patient outcomes and healthcare efficiency, a low-pressure dialysis access band could become a cornerstone in the standard of care for patients undergoing dialysis, improving their quality of life and reducing the burden on healthcare providers.

OBJECTS OF THE INVENTION:
The prime object of the present invention is to provide a low-pressure dialysis access band that effectively regulates the pressure applied to vascular access sites during dialysis, thereby reducing the risk of access-related complications. This device aims to extend the functional lifespan of arteriovenous (AV) fistulas and grafts by minimizing repetitive high-pressure impacts on vascular tissues, which are commonly associated with stenosis, thrombosis, and aneurysm formation. Through this optimized pressure regulation, the invention seeks to prevent chronic vascular trauma and improve the overall effectiveness of dialysis treatments.
Another object of the present invention is to enhance patient comfort and reduce anxiety associated with vascular access during dialysis. By incorporating pressure-sensing technology, the access band offers a gentle and adaptable pressure application that conforms to individual patient needs. The invention aims to alleviate discomfort and minimize post-dialysis complications such as swelling and tenderness, thus improving the overall patient experience. The design prioritizes user comfort, ensuring that the band remains comfortable even when worn for extended periods.
Yet another object of the present invention is to provide real-time monitoring and feedback of the pressure exerted on the vascular access site. By integrating sensors capable of detecting subtle changes in blood flow and pressure, the invention aims to allow healthcare providers and patients to continuously monitor access site conditions, adjusting pressure levels as needed to maintain optimal conditions. This real-time data collection and display serve as an early warning system, alerting users to any abnormal pressure changes that could lead to complications if left unaddressed.
Still another object of the present invention is to reduce the frequency of surgical interventions required to maintain dialysis access points. By preventing excessive strain on AV fistulas and grafts, the invention seeks to lower the incidence of complications that typically necessitate invasive corrective procedures, such as angioplasty or stenting. This reduction in the need for surgical interventions aligns with the goal of creating a preventive rather than reactive approach to vascular access management in dialysis patients.
A further object of the present invention is to lower the healthcare costs associated with dialysis access management. By minimizing the rate of access-related complications and reducing the need for hospitalization or corrective procedures, this invention aims to provide a cost-effective solution for both patients and healthcare providers. The innovation promises a preventive strategy that can decrease the overall financial burden on the healthcare system, contributing to more sustainable dialysis care practices.
An additional object of the present invention is to utilize biocompatible and flexible materials to ensure safety and durability in prolonged use. The access band is formulated to be non-irritating and hypoallergenic, accommodating a wide range of skin sensitivities while maintaining structural integrity under continuous use. The use of flexible materials enhances patient comfort and ensures the device is safe for extended wear without compromising the protection of the vascular access site.
Lastly, an object of the present invention is to create a low-maintenance and user-friendly device that patients can easily apply and remove independently. This object reflects the goal of empowering patients to take an active role in their dialysis care by providing them with a device that is simple to use, reliable, and compatible with daily routines. The access band's design emphasizes ease of use to improve patient adherence, ultimately contributing to the sustained health of vascular access points.

SUMMARY OF THE INVENTION:
The present invention is a low-pressure dialysis access band specifically configured to protect vascular access sites during dialysis by regulating and maintaining optimal pressure. By addressing the challenges associated with excessive pressure on arteriovenous (AV) fistulas and grafts, this invention seeks to improve patient comfort, extend the lifespan of access points, and reduce the risk of complications. The invention integrates advanced pressure-sensing technology within a comfortable, flexible band, allowing for real-time adjustments based on patient-specific needs and dynamic blood flow variations. The device's design emphasizes a preventive approach to dialysis access care, helping reduce the frequency of access-related complications and hospitalizations.
An inventive aspect of the invention is to provide a self-adjusting pressure control mechanism that allows the band to modulate the pressure applied to the vascular access site in response to real-time blood flow measurements. This feature is crucial for protecting the vascular site from over-compression, which can lead to ischemia, or under-compression, which may fail to prevent vascular trauma. The self-adjusting mechanism dynamically adapts to fluctuations in blood flow, ensuring that the pressure remains within a safe and effective range throughout the dialysis session.
Another inventive aspect of the invention is to provide continuous, real-time pressure monitoring through integrated sensors within the access band. These sensors detect subtle changes in pressure and blood flow at the access site, relaying this data to an external display or smartphone application. This feedback mechanism enables healthcare providers and patients to actively monitor the access site conditions, identifying any abnormalities early and allowing for prompt adjustments to pressure settings. By maintaining optimal pressure conditions, the invention significantly reduces the risk of stenosis, thrombosis, and other complications associated with prolonged high-pressure exposure.
Yet another inventive aspect of the invention is to provide a biocompatible, hypoallergenic material composition that enhances patient comfort and is suitable for extended use. The access band is formulated from flexible materials that conform to the patient's anatomy, ensuring a snug but comfortable fit that minimizes irritation and discomfort. The choice of material allows the device to be worn comfortably for the duration of the dialysis session and beyond, promoting patient adherence and offering continuous protection for the vascular access site.
Still another inventive aspect of the invention is to integrate a user-friendly interface that allows patients and healthcare providers to easily adjust settings, monitor data, and receive alerts on abnormal pressure levels. This interface, whether on a mobile device or standalone display, provides simple, intuitive controls and notifications, empowering users to manage the access band independently. The interface enhances the usability of the device, making it accessible for patients with varying levels of technical expertise and ensuring consistent, reliable usage.
A further inventive aspect of the invention is to offer a preventive approach to dialysis care by reducing the incidence of access-related complications and the need for invasive corrective procedures. By proactively managing the pressure exerted on the vascular site, the device decreases the likelihood of complications that commonly necessitate angioplasty, stenting, or surgical replacement of access points. This preventive approach represents a shift in dialysis care, focusing on long-term access site health and reducing the need for costly, invasive interventions.
An additional inventive aspect of the invention is to incorporate durable, easy-to-clean materials that are resistant to wear and tear, ensuring a long lifespan for the device. The band's materials are selected not only for patient comfort but also for durability under frequent use and cleaning cycles. This durability is essential for dialysis patients who require a device that can withstand repeated use without degrading in quality, ensuring that the access band remains effective over prolonged periods.
Lastly, an inventive aspect of the invention is to provide a low-maintenance design that allows patients to apply, adjust, and remove the access band independently. This feature empowers patients in their dialysis care, fostering greater independence and confidence in managing their vascular access site. The ease of use and minimal maintenance requirements encourage patients to incorporate the device into their regular dialysis routine, ultimately contributing to improved access site health and overall patient well-being.

BRIEF DESCRIPTION OF DRAWINGS:
The accompanying drawings illustrate various embodiments of "A Low-Pressure Dialysis Access Band," highlighting key aspects of its design and functionality. These figures are intended for illustrative purposes to aid in understanding the invention and are not meant to limit its scope.
FIG. 1 depicts a block diagram of a low-pressure dialysis access band, showing its components and pressure-regulation mechanism, according to an embodiment of the present invention.
The drawings provided will be further described in detail in the following sections. They offer a visual representation of the low-pressure dialysis access band's design, pressure-monitoring elements, and adjustment features, helping to clarify and support the detailed description of the invention.

DETAILED DESCRIPTION OF THE INVENTION:
In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural and logical changes may be made without departing from the spirit and scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents.
The present invention is described in brief with reference to the accompanying drawings. Now, refer in more detail to the exemplary drawings for the purposes of illustrating non-limiting embodiments of the present invention.
As used herein, the term "comprising" and its derivatives including "comprises" and "comprise" include each of the stated integers or elements but does not exclude the inclusion of one or more further integers or elements.
As used herein, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a device" encompasses a single device as well as two or more devices, and the like.
As used herein, the terms "for example", "like", "such as", or "including" are meant to introduce examples that further clarify more general subject matter. Unless otherwise specified, these examples are provided only as an aid for understanding the applications illustrated in the present disclosure, and are not meant to be limiting in any fashion.
As used herein, the terms ""may", "can", "could", or "might" be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.
Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. These exemplary embodiments are provided only for illustrative purposes and so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those of ordinary skill in the art. The invention disclosed may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.
Various modifications will be readily apparent to persons skilled in the art. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Moreover, all statements herein reciting embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases, it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.
All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition and persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.
With reference to FIG. 1, in an embodiment of the present invention, the present invention relates to a low-pressure dialysis access band (100) configured to provide optimal pressure management for vascular access sites during dialysis. The invention specifically addresses the challenges of maintaining vascular access site health by incorporating a pressure-regulating mechanism (5), one or more integrated sensors (10), and a feedback system (15) that together form a system capable of dynamically adjusting and monitoring the compression applied to the vascular access site in real-time. Through this advanced functionality, the access band (100) offers significant improvements in patient safety, comfort, and overall outcomes associated with dialysis treatment.
The access band (100) employs a sophisticated pressure-regulating mechanism (5) that is specifically configured to apply gentle, controlled compression on the vascular access site. The pressure-regulating mechanism (5) is configured to dynamically respond to the patient's blood flow and pressure variations, adjusting its compression to maintain a low-pressure environment that minimizes the risk of vascular damage. The automatic adjustment feature (5a) within the pressure-regulating mechanism (5) detects changes in blood flow and pressure, enabling the device to modulate compression in real-time. This feature is essential to ensure the pressure exerted on the access site is neither excessive, which could lead to ischemia and other complications, nor insufficient, which could fail to protect the site from the high pressures typically experienced during dialysis.
Integrated within the access band (100) are one or more sensors (10) configured to continuously monitor real-time blood flow and pressure at the vascular access site. These sensors (10) are calibrated to detect subtle changes in pressure that may arise during the dialysis process, thereby providing an accurate picture of the conditions at the access site. The data collected by the sensors (10) is communicated to the feedback system (15), which is responsible for processing this information and making the necessary adjustments to the pressure-regulating mechanism (5). Through this constant monitoring, the sensors (10) help maintain optimal conditions at the access site, reducing the likelihood of complications such as stenosis, thrombosis, and aneurysms associated with high-pressure environments.
The feedback system (15) is a central component of the access band (100), configured to interpret the data provided by the sensors (10) and make real-time adjustments to the pressure-regulating mechanism (5). The feedback system (15) is configured to maintain an optimal low-pressure environment at the access site during dialysis, enhancing the overall health of the vascular access site. Additionally, the feedback system (15) includes an external communication feature that enables data transmission to a separate device, such as a smartphone or a dedicated display interface. Through this external device, patients and healthcare providers can receive real-time alerts and updates on the status of the access site, ensuring that any abnormal pressure levels or blood flow inconsistencies are promptly addressed. The user-friendly interface on the external device offers simplified controls, allowing users to view data, adjust settings, and receive notifications in an intuitive format.
Constructed from a flexible, hypoallergenic material, the pressure-regulating mechanism (5) in the access band (100) is configured to conform comfortably to the patient's body, enhancing the overall comfort of the device. This material choice ensures that the access band (100) is gentle on the skin, minimizes the risk of irritation, and can be worn comfortably for extended periods, including the duration of dialysis sessions. The flexible material allows the device to adjust snugly around the vascular access site without causing undue pressure or discomfort, accommodating patients with varying anatomical needs.
Moreover, the access band (100) includes a durable, biocompatible material composition that maintains structural integrity even after prolonged use. This durability is essential for patients who require consistent protection for their vascular access site, as it allows the access band (100) to withstand repeated wear and regular cleaning without degrading in quality. The hypoallergenic and biocompatible properties also reduce the risk of skin reactions, ensuring that the device is safe for patients with sensitive skin or those prone to allergies.
The feedback system (15) is programmed to recognize and alert users to pressure levels outside a predefined safe range. By proactively identifying deviations from optimal pressure conditions, the feedback system (15) serves as a preventive care tool, allowing patients and healthcare providers to address potential issues before they escalate into serious complications. For example, if the pressure at the vascular access site rises beyond the established threshold, the feedback system (15) can trigger an alert, prompting users to adjust the band or seek medical attention. This functionality significantly enhances the preventive capabilities of the access band (100), offering patients greater control and confidence in managing their dialysis care.
The access band (100) is configured for easy application and removal, allowing patients to manage the device independently before and after dialysis sessions. This ease of use is achieved through a simple design that facilitates quick adjustments and comfortable positioning around the vascular access site. The device is equipped with an intuitive clasp or fastening system, ensuring that patients can securely attach the access band (100) without the need for complex adjustments or assistance from healthcare providers. By empowering patients to handle the access band (100) independently, the invention promotes self-care and contributes to the overall convenience of dialysis treatment.
In addition to the core components, the invention incorporates a method for effectively using the low-pressure dialysis access band (100) to optimize vascular access health. This method includes applying the access band (100) around the vascular access site, utilizing the sensors (10) to continuously monitor blood flow and pressure, and dynamically adjusting the pressure-regulating mechanism (5) based on real-time feedback from the sensors (10). The feedback system (15) provides alerts and data to users, enabling proactive monitoring and intervention to prevent complications associated with dialysis. Through this method, patients and healthcare providers can ensure that the vascular access site remains protected and in optimal condition during each dialysis session.
The integration of an external communication system in the access band (100) enhances its usability by allowing patients and healthcare providers to access information on pressure levels and blood flow in real-time. The external device, such as a smartphone application or dedicated display, provides a convenient platform for users to monitor the access site, adjust settings, and receive alerts. This communication feature enables remote monitoring and ensures that patients receive timely updates, even if they are not physically observing the device. This capability adds a layer of security, as healthcare providers can be alerted to any complications remotely, allowing them to advise patients on necessary actions to take.
By providing continuous pressure management and real-time monitoring, the access band (100) offers a preventive approach to dialysis care. The device's ability to dynamically adjust to the physiological needs of the patient during dialysis sets it apart from conventional compression bands, which lack the capability to respond to real-time data. This innovation significantly reduces the frequency of access-related complications and minimizes the need for corrective surgical procedures, such as angioplasty and stenting, which are often required to restore functionality to damaged vascular access sites.
Therefore, the low-pressure dialysis access band (100) represents a comprehensive solution for maintaining vascular access health in dialysis patients. The device's pressure-regulating mechanism (5), sensors (10), and feedback system (15) work together to provide a controlled, low-pressure environment, enhancing the durability of arteriovenous fistulas and grafts. The biocompatible materials and user-friendly design make the access band (100) a comfortable and practical option for patients, while the external communication system and real-time feedback features empower users to actively monitor and manage their vascular access conditions. Through its preventive care approach, the invention reduces the burden of dialysis-related complications, improves patient outcomes, and enhances the overall quality of life for those undergoing dialysis treatment.

The working of the low-pressure dialysis access band (100) is centered around its ability to dynamically regulate compression at the vascular access site, monitor real-time pressure and blood flow, and provide instant feedback to maintain an optimal low-pressure environment during dialysis. The invention is configured to improve vascular access health by minimizing excessive pressure and protecting the site from trauma, thereby reducing complications and enhancing patient comfort.
When the access band (100) is applied to a patient's vascular access site, the pressure-regulating mechanism (5) is activated. This mechanism is responsible for maintaining consistent, controlled pressure on the site by dynamically adjusting compression levels based on feedback from the sensors (10). The pressure-regulating mechanism (5) features an automatic adjustment feature (5a), which allows it to modulate the band's compression in response to fluctuations in blood flow and pressure detected by the sensors. For instance, if blood pressure increases during dialysis, the mechanism (5) automatically decreases compression to maintain a stable environment around the access site. Conversely, if blood flow drops, the mechanism (5) can slightly increase pressure to ensure that the vascular site remains supported.
Integrated sensors (10) within the band continuously monitor the blood flow and pressure at the access site. These sensors detect subtle changes that occur during dialysis and provide real-time data on the vascular conditions at the site. The sensors are calibrated to capture and process pressure and flow measurements accurately, providing valuable feedback to the system. This continuous monitoring ensures that any pressure deviations that could harm the vascular site are promptly identified, allowing the band to adjust compression as needed to prevent potential damage.
The data collected by the sensors (10) is communicated to the feedback system (15), which processes this information and provides commands to the pressure-regulating mechanism (5). The feedback system (15) is configured to interpret the data and ensure that the pressure-regulating mechanism responds appropriately to changes in blood flow and pressure. The system continuously analyzes this data to maintain an ideal low-pressure environment around the access site. Additionally, the feedback system (15) includes pre-set safe thresholds for pressure levels. If pressure measurements exceed or fall below these limits, the feedback system (15) triggers an alert, notifying the patient or healthcare provider about the abnormality.
To enhance usability and facilitate monitoring, the feedback system (15) is configured to communicate data to an external device, such as a smartphone application or a dedicated display interface. This communication feature allows users to view real-time data on pressure and flow conditions, as well as receive notifications and alerts on abnormal readings. For example, if pressure levels become too high, an alert is sent to the external device, prompting the user to take appropriate actions. This feature empowers patients to monitor their vascular access health actively and enables healthcare providers to remotely observe the patient's condition during and after dialysis sessions.
The material composition of the access band (100) also plays a crucial role in its working. Constructed from flexible, hypoallergenic materials, the pressure-regulating mechanism (5) is configured to conform comfortably to the patient's anatomy while maintaining gentle but effective pressure on the access site. This material provides a secure fit without irritating the skin, which is essential for patients who may need to wear the band for extended periods. The hypoallergenic, biocompatible properties of the band minimize the risk of skin reactions, allowing patients with sensitive skin to use the device safely.
In addition to dynamic pressure adjustment, the access band (100) offers a user-friendly interface that simplifies the operation and monitoring process. The interface on the external device allows users to access data, modify settings, and receive alerts, providing intuitive control over the band's functionality. Patients or caregivers can easily adjust parameters such as the sensitivity of pressure adjustments, making the device customizable to individual needs. This user-friendly design ensures that the device remains accessible for patients with different levels of technical ability, enhancing its appeal and ease of integration into daily dialysis routines.
During the dialysis session, the continuous monitoring and dynamic response of the pressure-regulating mechanism (5) significantly reduce the risk of vascular damage by preventing prolonged high-pressure exposure. By actively adjusting to fluctuations in blood flow, the access band (100) minimizes the potential for complications such as stenosis, thrombosis, and aneurysms, which are commonly associated with dialysis access sites. The preventive nature of the access band (100) not only extends the lifespan of vascular access points but also reduces the need for corrective surgical procedures, contributing to improved long-term patient outcomes.
After the dialysis session, the band can be easily removed by the patient, thanks to its simple application and removal mechanism. The access band (100) is configured to be manageable by the patient without requiring extensive assistance from healthcare providers, fostering patient independence. The device's durable and flexible construction ensures that it withstands repeated use, offering reliable performance over prolonged periods without compromising comfort or efficacy.
Therefore, the working of the low-pressure dialysis access band (100) involves a coordinated system of pressure regulation, real-time monitoring, and responsive feedback to create a safe, low-pressure environment at the vascular access site during dialysis. The device's pressure-regulating mechanism (5), sensors (10), and feedback system (15) work together to adjust compression in response to physiological changes, protect vascular health, and prevent complications. Through its innovative design and user-friendly features, the access band (100) provides patients and healthcare providers with an effective tool for proactive dialysis care.

ADVANTAGES OF THE INVENTION:
The prime advantage of the invention is to provide a controlled, low-pressure environment at the vascular access site during dialysis, significantly reducing the risk of complications such as stenosis, thrombosis, and aneurysms.
Another advantage of the invention is to enhance patient comfort by utilizing a flexible, hypoallergenic material that conforms to the patient's body, minimizing skin irritation and allowing for extended wear without discomfort.
Yet another advantage of the invention is its real-time monitoring capability, allowing healthcare providers and patients to continuously track pressure and blood flow, ensuring immediate detection of any abnormal conditions at the access site.
Still another advantage of the invention is the automated pressure-regulating mechanism, which dynamically adjusts compression in response to blood flow changes, reducing the likelihood of vascular trauma during each dialysis session.
An additional advantage of the invention is its user-friendly interface, enabling patients to easily monitor data, adjust settings, and receive alerts, empowering them to manage the device independently with minimal assistance.
A further advantage of the invention is its compatibility with external devices, such as smartphones, which provide real-time notifications on access site conditions, allowing for remote monitoring by healthcare providers.
Another advantage of the invention is its durability, as it is constructed from biocompatible materials that maintain structural integrity over repeated uses, ensuring consistent, reliable performance throughout long-term dialysis care.
Yet another advantage of the invention is its preventive care approach, which minimizes the need for corrective surgeries, reducing hospital visits and overall healthcare costs associated with dialysis-related vascular access issues.
, Claims:CLAIM(S):
We Claim:
1. A low-pressure dialysis access band (100), comprising:
a. a pressure-regulating mechanism (5) configured to dynamically adjust the compression applied to a vascular access site;
b. one or more sensors (10) integrated within the band to monitor real-time blood flow and pressure at the access site; and
c. a feedback system (15) connected to the sensors to provide real-time data on pressure and blood flow changes, wherein the feedback system is configured to adjust the pressure-regulating mechanism to maintain an optimal low-pressure environment at the access site during dialysis.
2. The access band of claim 1, wherein the pressure-regulating mechanism (5) includes an automatic adjustment feature (5a) to modulate compression in response to detected changes in blood flow and pressure.
3. The access band of claim 1, wherein the sensors are configured to communicate data to an external device, providing real-time alerts on abnormal pressure levels or flow inconsistencies.
4. The access band of claim 3, wherein the external device comprises a smartphone application or display interface that allows users to view data, adjust settings, and receive alerts related to the pressure and condition of the vascular access site.
5. The access band of claim 1, wherein the pressure-regulating mechanism is constructed from a flexible, hypoallergenic material configured to conform to the patient's body and enhance comfort during use.
6. The access band of claim 1, further comprising a biocompatible, durable material composition that maintains structural integrity and comfort during prolonged use, minimizing irritation and risk of allergic reactions.
7. The access band of claim 1, wherein the feedback system includes a user-friendly interface that provides patients and healthcare providers with simplified control options and notifications, allowing them to adjust pressure settings and monitor vascular access health.
8. The access band of claim 1, wherein the feedback system is programmed to recognize and alert users to pressure levels outside a predefined safe range, promoting preventive care for vascular access sites.
9. The access band of claim 1, wherein the band is configured for easy application and removal, allowing patients to independently manage the device before and after dialysis sessions.
10. A method of using the low-pressure dialysis access band of claim 1, comprising:
a. applying the access band around a patient's vascular access site;
b. utilizing the sensors to continuously monitor blood flow and pressure at the access site;
c. dynamically adjusting the pressure-regulating mechanism based on feedback from the sensors to maintain a controlled, low-pressure environment;
d. providing real-time alerts and data on the vascular access conditions, enabling proactive monitoring and intervention to prevent complications associated with dialysis.

Documents

NameDate
202411085713-COMPLETE SPECIFICATION [07-11-2024(online)].pdf07/11/2024
202411085713-DECLARATION OF INVENTORSHIP (FORM 5) [07-11-2024(online)].pdf07/11/2024
202411085713-DRAWINGS [07-11-2024(online)].pdf07/11/2024
202411085713-EDUCATIONAL INSTITUTION(S) [07-11-2024(online)].pdf07/11/2024
202411085713-EVIDENCE FOR REGISTRATION UNDER SSI [07-11-2024(online)].pdf07/11/2024
202411085713-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [07-11-2024(online)].pdf07/11/2024
202411085713-FIGURE OF ABSTRACT [07-11-2024(online)].pdf07/11/2024
202411085713-FORM 1 [07-11-2024(online)].pdf07/11/2024
202411085713-FORM FOR SMALL ENTITY(FORM-28) [07-11-2024(online)].pdf07/11/2024
202411085713-FORM-9 [07-11-2024(online)].pdf07/11/2024
202411085713-POWER OF AUTHORITY [07-11-2024(online)].pdf07/11/2024
202411085713-PROOF OF RIGHT [07-11-2024(online)].pdf07/11/2024
202411085713-REQUEST FOR EARLY PUBLICATION(FORM-9) [07-11-2024(online)].pdf07/11/2024

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