SBIR-STTR Award

Inline RF Warmer Using RF Technology
Award last edited on: 8/4/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NIBIB
Total Award Amount
$433,190
Award Phase
2
Solicitation Topic Code
286
Principal Investigator
Ahmad Khanifar

Company Information

Advanced Medical Device Technologies Inc

895 Dove Street 3rd Floor
Newport Beach, CA 92660
   (949) 243-0407
   info@advancedmdt.com
   www.advancedmdt.com
Location: Single
Congr. District: 48
County: Orange

Phase I

Contract Number: 1R43EB031763-01
Start Date: 9/1/2021    Completed: 8/31/2022
Phase I year
2021
Phase I Amount
$216,595
Hypothermia is a common condition encountered in a variety of clinical settings including trauma, critical care,peri/post-operative care and during administration of renal replacement therapy. The causes of hypothermia arevast and include critical illness, induction of anesthesia or iatrogenic administration of sub-body temperature fluids(i.e. fluids or blood products). Effective prevention and treatment of hypothermia is of vital importance given that itspresence is associated with poor clinical outcomes including increased mortality. Of the available therapies,methods which increase core body temperature [warm intravenous (IV) fluids], are more effective than externalmethods (heating blankets). Hence, warming of fluids being administered is a well-accepted and commonly usedtechnique for prevention and treatment of hypothermia. Currently available techniques used to warm medical fluidsrely on simple heat-exchange methodologies (convection, induction) which are outdated and have numerousshortcomings. The devices commonly used can be divided into two groups:1) devices which accommodate large fluidvolumes at fast rates. These are large, lack portability, consume greater energy, and require extensive set-up. 2) Moreportable devices which are slower and not suitable for large volume resuscitation. In both groups, the need for disposableswhich disrupt the native delivery system increases cost and risk of contamination leading to major patient safety issues.Moreover, the set-up process for both groups can be complicated and cumbersome.The proposed research aims to develop an innovative technology to safely warm medical fluids in a real-time inlinefashion using radiofrequency (RF) energy. RF (microwave) is more energy efficient and allows for several importantadvantages including increased portability. Furthermore, in the proposed technology the issue of hotspots, whichpreviously limited the use of this technique, is mitigated via a novel and innovative design thereby allowing forRF energy to be directly applied to the traversing fluid in the delivery tubing. This mode of transfer of energycircumvents the need for disposables, lowering costs, reducing risk of contamination and improving ease-of-use.The proposed project aims to demonstrate the feasibility of design and development of a RF fluid warmerapparatus which avoids hotspot generation by a team of RF engineers using design/quality control processes.This will be done in consultation with clinicians in various specialties who routinely treat hypothermia andspecialist in the regulatory aspects of medical device development.Given that hypothermia is a serious and common complication in a variety of medical settings, the potential utility forsuch a technology is vast and can include emergency response teams, military medical systems, hospitals,outpatient surgery centers and dialysis providers. In addition, the ability to warm medical fluids safely and effectivelyin an easy to operate manner with improved patient safety can enhance more widespread use of this technologythereby increasing its market share. Finally, once developed this technology can be adapted for use in variousother areas affected by hypothermia (i.e. plasmaphoresis, cardiopulmonary bypass).

Public Health Relevance Statement:
Hypothermia is a serious and common condition encountered in a variety of clinical settings whose timely and effective treatment is of vital importance and can be lifesaving. The overall objective of this project is to develop a portable, energy-efficient, easy-to-use device which utilizes microwave energy to warm intravenous fluids in a inline fashion avoiding costly disposables that increase the risk of contamination. Development of a device with such favorable features, can significantly improve physician/patient access to this crucial therapy, allow for more widespread use of this technology, and significantly improve patient outcomes including survival.

Project Terms:
absorption ; Accidents ; Affect ; Ambulances ; Ambulatory Surgical Procedures ; Ambulatory Surgery ; Outpatient Surgery ; Anesthesia procedures ; Anesthesia ; Biological Sciences ; Biologic Sciences ; Bioscience ; Life Sciences ; Body Temperature ; Cardiopulmonary Bypass ; Heart-Lung Bypass ; heart bypass ; Certification ; Clams ; Clinical Research ; Clinical Study ; Complication ; Consultations ; Critical Care ; Critical Illness ; Critically Ill ; Dialysis procedure ; Dialysis ; dialysis therapy ; intravenous administration ; Energy Transfer ; Engineering ; Erythrocytes ; Blood erythrocyte ; Erythrocytic ; Marrow erythrocyte ; Red Blood Cells ; Red Cell ; blood corpuscles ; Extravasation ; Leakage ; Spillage ; Fatigue ; Lack of Energy ; Feedback ; Future ; Goals ; Heating ; Hospitals ; natural hypothermia ; Hypothermia ; In Vitro ; Industry ; Laboratories ; Medical Device ; Methods ; Methodology ; Microprocessor ; microwave electromagnetic radiation ; Microwave Electromagnetic ; Microwaves ; microwave radiation ; Military Personnel ; Armed Forces Personnel ; Military ; military population ; mortality ; Legal patent ; Patents ; Patients ; Physicians ; Postoperative Care ; post-operative care ; Public Health ; Quality Control ; Research ; Resuscitation ; Risk ; Running ; Safety ; Savings ; medical specialties ; Specialty ; Stress ; Technology ; Temperature ; Testing ; Time ; Weight ; Generations ; Measures ; Treatment outcome ; Businesses ; Specialist ; Tube ; base ; heat exchanger ; sensor ; improved ; Area ; Clinical ; Phase ; Medical ; Renal Replacement Therapy ; Kidney Replacement Therapy ; Convection ; Collaborations ; fluid ; liquid ; Liquid substance ; Exposure to ; Intravenous ; Life ; Pattern ; Techniques ; System ; blood product ; interest ; meetings ; Consult ; Infusion ; Infusion procedures ; innovative technologies ; fluid flow ; Performance ; Structure ; novel ; Prevention ; Devices ; Modeling ; Sampling ; portability ; patient safety ; Provider ; Effectiveness ; Intravenous Fluid ; IV Fluid ; preventing ; prevent ; Address ; Length ; Academia ; device development ; instrument development ; Device or Instrument Development ; iatrogenic ; iatrogenically ; iatrogenicity ; Iatrogenesis ; research clinical testing ; Clinical Evaluation ; Clinical Testing ; clinical test ; Patient-Focused Outcomes ; Patient outcome ; Patient-Centered Outcomes ; Process ; Development ; developmental ; preclinical study ; pre-clinical study ; cost ; virtual ; design ; designing ; Outcome ; Consumption ; Trauma ; innovation ; innovate ; innovative ; clinically relevant ; clinical relevance ; prototype ; effective therapy ; effective treatment ; clinical practice ; screening ; Emergency response ; radio frequency ; radiofrequency ; battlefield injury ;

Phase II

Contract Number: 7R43EB031763-02
Start Date: 3/7/2022    Completed: 8/31/2022
Phase II year
2021
Phase II Amount
$216,595
Hypothermia is a common condition encountered in a variety of clinical settings including trauma, critical care,peri/post-operative care and during administration of renal replacement therapy. The causes of hypothermia arevast and include critical illness, induction of anesthesia or iatrogenic administration of sub-body temperature fluids(i.e. fluids or blood products). Effective prevention and treatment of hypothermia is of vital importance given that itspresence is associated with poor clinical outcomes including increased mortality. Of the available therapies,methods which increase core body temperature [warm intravenous (IV) fluids], are more effective than externalmethods (heating blankets). Hence, warming of fluids being administered is a well-accepted and commonly usedtechnique for prevention and treatment of hypothermia. Currently available techniques used to warm medical fluidsrely on simple heat-exchange methodologies (convection, induction) which are outdated and have numerousshortcomings. The devices commonly used can be divided into two groups:1) devices which accommodate large fluidvolumes at fast rates. These are large, lack portability, consume greater energy, and require extensive set-up. 2) Moreportable devices which are slower and not suitable for large volume resuscitation. In both groups, the need for disposableswhich disrupt the native delivery system increases cost and risk of contamination leading to major patient safety issues.Moreover, the set-up process for both groups can be complicated and cumbersome.The proposed research aims to develop an innovative technology to safely warm medical fluids in a real-time inlinefashion using radiofrequency (RF) energy. RF (microwave) is more energy efficient and allows for several importantadvantages including increased portability. Furthermore, in the proposed technology the issue of hotspots, whichpreviously limited the use of this technique, is mitigated via a novel and innovative design thereby allowing forRF energy to be directly applied to the traversing fluid in the delivery tubing. This mode of transfer of energycircumvents the need for disposables, lowering costs, reducing risk of contamination and improving ease-of-use.The proposed project aims to demonstrate the feasibility of design and development of a RF fluid warmerapparatus which avoids hotspot generation by a team of RF engineers using design/quality control processes.This will be done in consultation with clinicians in various specialties who routinely treat hypothermia andspecialist in the regulatory aspects of medical device development.Given that hypothermia is a serious and common complication in a variety of medical settings, the potential utility forsuch a technology is vast and can include emergency response teams, military medical systems, hospitals,outpatient surgery centers and dialysis providers. In addition, the ability to warm medical fluids safely and effectivelyin an easy to operate manner with improved patient safety can enhance more widespread use of this technologythereby increasing its market share. Finally, once developed this technology can be adapted for use in variousother areas affected by hypothermia (i.e. plasmaphoresis, cardiopulmonary bypass).

Public Health Relevance Statement:
Hypothermia is a serious and common condition encountered in a variety of clinical settings whose timely and effective treatment is of vital importance and can be lifesaving. The overall objective of this project is to develop a portable, energy-efficient, easy-to-use device which utilizes microwave energy to warm intravenous fluids in a inline fashion avoiding costly disposables that increase the risk of contamination. Development of a device with such favorable features, can significantly improve physician/patient access to this crucial therapy, allow for more widespread use of this technology, and significantly improve patient outcomes including survival.

Project Terms: