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VF DOPPLER SMART SENSOR FOR DIALYSIS AND VASCULAR APPLICATIONS

William F Weitzel
University Of Michigan At Ann Arbor, 1040 Wolverine Tower, Ann Arbor, Mi 48109-1274

Grant 5RC1HL101881-02 from Office Of The Director, National Institutes Of Health

Abstract: This application addresses broad Challenge Area 15 Translational Science and specific Challenge Topic 15-RR-101 Applied Translational Technology Development. It is evident that prior to dialysis access failure (thrombosis), access flow decreases for every dialysis patient from a baseline value to zero over some time period. However, the natural history and variation of access failure is still poorly understood, as evidenced by mixed results when access flow monitoring is implemented clinically. What is known is that customary monthly access flow monitoring is not frequent enough in many clinical settings. Since the effectiveness of access surveillance depends on the frequency with which monitoring can be performed, an easy-to-use and accurate method of measuring access flow is needed to understand flow variation and to determine how to optimally monitor patients with differing characteristics. The new instrument being developed and tested in this project is based on mature Doppler technology mitigating development risk, yet will employ a novel measurement method, technologically advanced electronics and software to make a user-friendly, low-cost Doppler- based monitoring device tailored for dialysis access monitoring. This smart sensor will allow cost-effective, accurate flow monitoring during each dialysis treatment for every patient, which is essential to optimize combined sensitivity and specificity for this clinical application. The results of this proposal will 1) improve dialysis decision-making leading to a paradigm shift to optimize access monitoring and 2) provide a platform Doppler device for other vascular applications. Further, this project will actually reduce dialysis vascular access cost. Realistic estimates indicate $300 million in annual savings in the US alone, while stimulating jobs in the technical healthcare sector. It is important to fund technologies that will make US workers more competitive in the global marketplace by reducing overall healthcare costs. This project achieves the scientific and economic objectives of the ARRA. This project will result in a low-cost compact Doppler based smart sensor for dialysis vascular access management. This device and technology will reduce dialysis healthcare cost and are easily generalizable to other vascular applications, offering a high-performance alternative to existing Doppler devices. The project supports rapid translation into the private sector and job creation achieving scientific and economic stimulus objectives of the ARRA

Keywords: Address; Adoption; Algorithms; Area; Blood Vessels; California; Career Development Awards; Career Development Awards and Programs; Career Development Programs K-Series; Characteristics; Clinical; Clinical Research; Clinical Study; Collaborations; Communities; Computer Programs; Computer software; Decision Making; Development; Devices; Diagnosis, Ultrasound; Diagnostic; Dialysis; Dialysis patients; Dialysis procedure; ESRD; Echography; Echotomography; Economics; Effectiveness; Electronics; End stage renal failure; End-Stage Kidney Disease; Engineering; Engineerings; FLR; Failure (biologic function); Frequencies (time pattern); Frequency; Funding; Goals; Grant; Health Care Costs; Health Care Sector; Health Costs; Healthcare Costs; Healthcare Sector; Hemodialyses; Hemodialysis; Investigators; Jobs; K-Awards; K-Series Research Career Programs; Laboratories; Laboratory Study; Lead; Measurement; Measures; Medical Imaging, Ultrasound; Mentors; Methods; Michigan; Monitor; NIH; National Institutes of Health; National Institutes of Health (U.S.); Natural History; Occupations; Patient Monitoring; Patients; Pb element; Performance; Prevention; Private Sector; Professional Postions; Programs (PT); Programs [Publication Type]; Randomized; Randomized Clinical Trials; Renal Disease, End-Stage; Research Career Program; Research Career Programs, K-Series; Research Institute; Research Personnel; Researchers; Risk; Savings; Sensitivity and Specificity; Software; Stimulus; System; System, LOINC Axis 4; Technology; Testing; Thrombosis; Time; Transducers; Translational Research; Translational Research Enterprise; Translational Science; Translations; Ultrasonic Imaging; Ultrasonogram; Ultrasonography; Ultrasound Test; Ultrasound, Medical; United States; United States National Institutes of Health; Universities; Validation; Variant; Variation; ing; base; clinical applicability; clinical application; computer program/software; cost; design; designing; diagnostic ultrasound; dialysis therapy; failure; heavy metal Pb; heavy metal lead; improved; instrument; monitoring device; novel; programs; prospective; randomisation; randomization; randomly assigned; sensor; sonogram; sonography; sound measurement; technology development; translation research enterprise; ultrasound; ultrasound imaging; ultrasound scanning; user-friendly; vascular

Relevance: NARRATIVE This project will result in a low-cost compact Doppler based smart sensor for dialysis vascular access management. This device and technology will reduce dialysis healthcare cost and are easily generalizable to other vascular applications, offering a high-performance alternative to existing Doppler devices. The project supports rapid translation into the private sector and job creation achieving scientific and economic stimulus objectives of the ARRA

Project start date: 2009-09-30

Project end date: 2011-08-31

Budget start date: 1-SEP-2010

Budget end date: 31-AUG-2011

PFA/PA: RFA-OD-09-003

5RC1HL101881-02 (2010): $500000


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Grants awarded to William F Weitzel

VF DOPPLER SMART SENSOR FOR DIALYSIS AND VASCULAR APPLICATIONS

William F Weitzel, Associate Professor
University Of Michigan At Ann Arbor, 1040 Wolverine Tower, Ann Arbor, Mi 48109-1274

Grant 1RC1HL101881-01 from Office Of The Director, National Institutes Of Health

Abstract: This application addresses broad Challenge Area 15 Translational Science and specific Challenge Topic 15-RR-101 Applied Translational Technology Development. It is evident that prior to dialysis access failure (thrombosis), access flow decreases for every dialysis patient from a baseline value to zero over some time period. However, the natural history and variation of access failure is still poorly understood, as evidenced by mixed results when access flow monitoring is implemented clinically. What is known is that customary monthly access flow monitoring is not frequent enough in many clinical settings. Since the effectiveness of access surveillance depends on the frequency with which monitoring can be performed, an easy-to-use and accurate method of measuring access flow is needed to understand flow variation and to determine how to optimally monitor patients with differing characteristics. The new instrument being developed and tested in this project is based on mature Doppler technology mitigating development risk, yet will employ a novel measurement method, technologically advanced electronics and software to make a user-friendly, low-cost Doppler- based monitoring device tailored for dialysis access monitoring. This smart sensor will allow cost-effective, accurate flow monitoring during each dialysis treatment for every patient, which is essential to optimize combined sensitivity and specificity for this clinical application. The results of this proposal will 1) improve dialysis decision-making leading to a paradigm shift to optimize access monitoring and 2) provide a platform Doppler device for other vascular applications. Further, this project will actually reduce dialysis vascular access cost. Realistic estimates indicate $300 million in annual savings in the US alone, while stimulating jobs in the technical healthcare sector. It is important to fund technologies that will make US workers more competitive in the global marketplace by reducing overall healthcare costs. This project achieves the scientific and economic objectives of the ARRA. This project will result in a low-cost compact Doppler based smart sensor for dialysis vascular access management. This device and technology will reduce dialysis healthcare cost and are easily generalizable to other vascular applications, offering a high-performance alternative to existing Doppler devices. The project supports rapid translation into the private sector and job creation achieving scientific and economic stimulus objectives of the ARRA

Keywords: Address; Adoption; Algorithms; Area; Blood Vessels; California; Career Development Awards; Career Development Awards and Programs; Career Development Programs K-Series; Characteristics; Clinical; Clinical Research; Clinical Study; Collaborations; Communities; Computer Programs; Computer software; Decision Making; Development; Devices; Diagnosis, Ultrasound; Diagnostic; Dialysis; Dialysis patients; Dialysis procedure; ESRD; Echography; Echotomography; Economics; Effectiveness; Electronics; End stage renal failure; End-Stage Kidney Disease; Engineering; Engineerings; FLR; Failure (biologic function); Frequencies (time pattern); Frequency; Funding; Goals; Grant; Health Care Costs; Health Care Sector; Health Costs; Healthcare Costs; Healthcare Sector; Hemodialyses; Hemodialysis; Investigators; Jobs; K-Awards; K-Series Research Career Programs; Laboratories; Laboratory Study; Lead; Measurement; Measures; Medical Imaging, Ultrasound; Mentors; Methods; Michigan; Monitor; Monitoring, Patient; NIH; National Institutes of Health; National Institutes of Health (U.S.); Natural History; Occupations; Patient Monitoring; Patients; Pb element; Performance; Prevention; Private Sector; Professional Postions; Programs (PT); Programs [Publication Type]; Randomized; Randomized Clinical Trials; Renal Disease, End-Stage; Research Career Program; Research Career Programs, K-Series; Research Institute; Research Personnel; Researchers; Risk; Savings; Sensitivity and Specificity; Software; Stimulus; System; System, LOINC Axis 4; Technology; Testing; Thrombosis; Time; Transducers; Translational Research; Translational Research Enterprise; Translational Science; Translations; Trials, Randomized Clinical; Ultrasonic Imaging; Ultrasonogram; Ultrasonography; Ultrasound Test; Ultrasound, Medical; United States; United States National Institutes of Health; Universities; Validation; Variant; Variation; base; clinical applicability; clinical application; computer program/software; cost; design; designing; diagnostic ultrasound; dialysis therapy; failure; heavy metal Pb; heavy metal lead; improved; instrument; monitoring device; novel; programs; prospective; public health relevance; randomisation; randomization; randomly assigned; sensor; sonogram; sonography; sound measurement; technology development; translation research enterprise; ultrasound; ultrasound imaging; ultrasound scanning; user-friendly; vascular

Relevance: NARRATIVE This project will result in a low-cost compact Doppler based smart sensor for dialysis vascular access management. This device and technology will reduce dialysis healthcare cost and are easily generalizable to other vascular applications, offering a high-performance alternative to existing Doppler devices. The project supports rapid translation into the private sector and job creation achieving scientific and economic stimulus objectives of the ARRA

Project start date: 2009-09-30

Project end date: 2011-08-31

Budget start date: 30-SEP-2009

Budget end date: 31-AUG-2010

PFA/PA: RFA-OD-09-003

1RC1HL101881-01 (2009): $500000


NOVEL METHODS FOR HEMODIALYSIS ACCESS EVALUATION

William F Weitzel, Associate Professor
University Of Michigan At Ann Arbor, 1040 Wolverine Tower, Ann Arbor, Mi 48109-1274

Grant 3K08DK062848-05S1 from National Institute Of Diabetes And Digestive And Kidney Diseases

Abstract: The objective of the candidate is to develop as an independent scientist with the capability of effectively applying bioengineering principles to solve clinical problems affecting patients with kidney diseases. To achieve this goal has designed a period of training to be supported through this application. The proposal combines an extensive education program coordinated with directed laboratory research in years 1-5 and clinical research in years 3-5. The research projects planned are practical and oriented toward solving important clinical problems by (1) Evaluating Variable Flow (VF) Doppler a potentially useful method of hemodialysis vascular access blood flow measurement and (2) Developing and evaluating Ultrasound Elasticity Imaging for hemodialysis access applications using high resolution speckle tracking techniques to accurately measure neointimal hyperplasia. The clinically focused research will be complemented by formal coursework that will provide the foundation of bioengineering principles required for ongoing evaluation of emerging technologies. The extensive resources available through the Biomedical Ultrasonics Lab (BUL) are ideal for this portion of the candidate´s Career Development Plan. The resources available through the Division of Nephrology and Radiology and Pathology Departments in the Medical School with the support of the University of Michigan Biomedical Engineering Department will provide an outstanding research experience for the candidate. The candidate will also participate in the University of Michigan´s Research Responsibility Program which includes lectures and symposia on responsibility in research, responsible authorship, responsible data management, conflict of interest, and protections for human subjects in research. In addition to the formal coursework and symposia, the candidate will participate in ethics discussions and research reviews within the Nephrology division. This Award will support the training needed to become an effective independent clinical investigator focused on bioengineering applications in medicine

Keywords: Affect; Algorithms; Architecture; Arteries; Arteriovenous Aneurysm; Arteriovenous fistula; Authorship; Award; Biomedical Engineering; Blood Flow Velocity; Blood Vessels; Blood flow; Body Tissues; Cadaver; Caring; Cell Communication and Signaling; Cell Components; Cell Signaling; Cell Structure; Cellular Infiltration; Cellular Structures; Characteristics; Clinical; Clinical Evaluation; Clinical Investigator; Clinical Research; Clinical Study; Clinical Testing; Complement; Complement Proteins; Complex; Conflict of Interest; Constriction, Pathologic; Constriction, Pathological; Data; Development Plans; Devices; Diagnosis, Ultrasound; Diagnostic; Dialysis; Dialysis patients; Dialysis procedure; Echography; Echotomography; Education; Educational aspects; Elasticity; Emergent Technologies; Emerging Technologies; Engineering / Architecture; Ethics; Evaluation; FLR; Failure (biologic function); Fibrosis; Fistula; Foundations; Frequencies (time pattern); Frequency; Goals; Hemodialyses; Hemodialysis; Hyperplasia; Hyperplastic; Image; Imaging Procedures; Imaging Techniques; In Vitro; Incidence; Interruption; Intervention; Intervention Strategies; Intracellular Communication and Signaling; Investigators; Kidney Diseases; Laboratory Research; Lectures; Lectures (PT); Lectures [Publication Type]; Longitudinal Studies; Measurement; Measures; Mechanics; Medical Imaging, Ultrasound; Medicine; Methods; Methods and Techniques; Methods, Other; Michigan; Monitor; Morbidity; Morbidity - disease rate; Nephrology; Nephropathy; Outcome; Pathology; Patients; Plans, Development; Post-Operative; Postoperative; Postoperative Period; Pressure; Pressure- physical agent; Process; Programs (PT); Programs [Publication Type]; Property; Property, LOINC Axis 2; Prosthesis; Prosthetic device; Prosthetics; R01 Mechanism; R01 Program; RPG; Radiology; Radiology Specialty; Radiology, General; Reference Standards; Renal Disease; Research; Research Grants; Research Personnel; Research Project Grants; Research Projects; Research Projects, R-Series; Research Resources; Research, Laboratory; Researchers; Resolution; Resources; Sampling; Schools, Medical; Science of Medicine; Scientist; Signal Transduction; Signal Transduction Systems; Signaling; Stenosis; Surveillance Methods; Technics, Imaging; Techniques; Testing; Thrombosis; Tissues; Training; Training Support; Ultrasonic; Ultrasonic Imaging; Ultrasonics; Ultrasonogram; Ultrasonography; Ultrasound Test; Ultrasound, Medical; Universities; Vascular Diseases; Vascular Disorder; Veins; Venous; bioengineering; bioengineering/biomedical engineering; biological signal transduction; blood flow measurement; blood vessel disorder; career development; clinical test; conference; data management; design; designing; diagnostic ultrasound; dialysis therapy; experience; experiment; experimental research; experimental study; failure; human subject protection; imaging; improved; in vivo; interventional strategy; kidney disorder; lectures; long-term study; medical schools; novel; phantom model; pre-clinical; preclinical; pressure; prevent; preventing; programs; prototype; renal disorder; research clinical testing; research study; sonogram; sonography; sound measurement; symposium; ultrasound; ultrasound imaging; ultrasound scanning; vascular

Project start date: 2009-12-17

Project end date: 2010-11-30

Budget start date: 17-DEC-2009

Budget end date: 30-NOV-2010

PFA/PA: PA-00-003

3K08DK062848-05S1 (2010): $53200


5K08DK062848-05 (2009): $132300

5K08DK062848-03 (2007): $132300

5K08DK062848-02 (2006): $132300

1K08DK062848-01A2 (2005): $132300