Novel, Ambulatory Cuff-less Non-invasive Arterial Blood Pressure Monitor

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL126424-01
Agency Tracking Number: R43HL126424
Amount: $197,973.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: HL14-011
Solicitation Year: 2016
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-01-01
Award End Date (Contract End Date): 2015-06-30
Small Business Information
5067 43RD ST S, Fargo, ND, 58104-6019
DUNS: 078783483
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (952) 944-0928
Business Contact
Phone: (612) 280-6328
Research Institution
DESCRIPTION provided by applicant The objective of this proposal is to complete the engineering development and testing of the Non Invasive Self calibrating Ambulatory Multi Modality NISAM blood pressure device to recognize hypertensive patients not currently identified using todayandapos s technology As well as providing better management of hypertensive patients by presenting a truer round the clock picture of their blood pressure BP variation Hypertension is increasing worldwide and represents an annual burden of $ billion in healthcare costs and resources in addition to $ billion yearly in lost productivity In the U S million people have hypertension though only are aware of their condition and only have it adequately controlled As with every disease state proper measurement of the problem is required Patient BP varies throughout the day week and year Existing in clinic BP measurements are infrequent and prone to errors The NISAM device combines four different sensor technologies into a wearable wireless non invasive BP measurement device that does not require an inflation cuff The device is worn over the patientandapos s brachial artery near the elbow At only cm x cm it is small unobtrusive and easy to use The device monitors patient movement and uses this information to assess when to collect data It can store months and up to years of data and wirelessly transmit this to a smart phone or to a hospitalandapos s electronic medical records system The NISAM deviceandapos s clinical benefits include an unobtrusive BP measurement system to identify hypertensive patients not currently recognized using todayandapos s methods as well as better managing existing hypertensive patients by understanding their true BP variation Also the NISAM device will display the BP data to support clinically actionable decisions through patient specific efficient and easy to understand diagnostic reports In addition patient compliance is greatly improved because this device does not require an inflation cuff which is disruptive to patientandapos s sleep In this Phase I proposal we will demonstrat feasibility and complete engineering development and testing of the NISAM BP sensors and actuator system and compare measurements with a standard clinical BP cuff in bench mock and human testing To achieve this objective a mock artery setup will be used to demonstrate performance and accuracy using the force actuator and four different sensor techniques Also prototypes will be built to measure the accuracy of the four sensors on human subjects and compare results to inflation cuff systems The long term goal is to clinically utilize the NISAM device to better identify and manage hypertensive patients using a small wearable wireless easy to use BP device PUBLIC HEALTH RELEVANCE High blood pressure BP effects million Americans impacts of the worldandapos s adult population and contributes toward organ damage and life threatening complications such as stroke heart attack and chronic heart failure In clinic BP measurements are taken only times per year and have errors which can be significant and existing hour BP monitors lack continuous real time BP measurements and use cuff inflations which cause disruptions in activities of daily living The projectandapos s long term goal is t provide a wireless easy to use non obtrusive BP measurement system using novel sensor measurement techniques to collect BP information in order to better identify and manage hypertensive patients End of Abstract

* Information listed above is at the time of submission. *

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