Computerized Infusion & Monitoring for Fetal Blood Transfusion

 

We propose to develop a fully automated blood infusion pump equipped with peripherals for monitoring the critical signs and parameters for the fetal blood transfusion operation. The proposed system is called the Computerized Infusion and Monitoring System for Fetal Blood Transfusion, or Computerized Fetal Transfusion System (CFTS) for short. It is to facilitate the blood transfusion operations with high precision and reliability under full control of the surgeon. Intrauterine fetal blood transfusion for Rh disease (Rhesus isoimmunisation) is a lifesaving operation which becomes necessary when Rh-sensitized mother’s immune system attacks and destroys fetal red blood cells endangering the life of the fetus during pregnancy. The fetal blood transfusion through the umbilical vein in the placenta is a delicate operation providing blood to fetus directly with fast positive results. Such operation may need to be repeated multiple times during a pregnancy.

More than 90% of fetuses without hydrops (accumulation of fluid in body due to lack of oxygen in blood) and more than 75% of fetuses with hydrops are saved by such operations. Ultrasonic and Doppler color imaging are used to monitor position of the fetus, position of the needle, and the blood injection into the umbilical vein. The blood infusion requires steady and relative high pressure due to infusion line resistance, blood viscosity and small diameter of the needle. Further, the close monitoring of heart rate of the fetus, the amount of the blood and red cells received by the fetus, and ascertaining that needle remains in the umbilical vein. While positioning and control of the needle remain under full manual control of the surgeon, the CFTS can perform other required important tasks to assist the surgeon and make the operation safer. The proposed CFTS provides: (1) computerized control of blood infusion, saline injection, and drawing blood sample for analysis, (2) continuous measuring and monitoring of pressure and blood flow in the fusion line , and (3) computer-based monitoring of the vital signs from the mother and the fetus via touch-screen control and display panel. Outcomes of this research will furnish initial results for proposal submission to federal agencies such as NIH, NSF, and DoD for further research and development efforts. Continuation of this research will enable full development and complete clinical testing of CFTS and expanding its applications for other operations, e.g. for twin-to-twin transfusion syndrome, general blood transfusion, and IV fluid. Furthermore, we envision future version of the proposed system equipped with more advanced features such as voice recognition capabilities and wireless connections which would further assist the surgeon and increase safety

Project Start Date: The project started at UTD and UTA on June 1, 2012.

 

Project Progress:

  • The research project has met all its key milestones and has shown proof of concept as set in the proposal originally.
  • Regular meetings, weekly teleconferencing, and excellent collaborative efforts among the investigators and their teams at UTD, UTA, and Harris Methodist Hospital (HMH) in Fort Worth were instrumental in achieving the project’s objectives.
  • With the consent of patient, Dr. Behbehani and Dr. Panahi attended and observed a Fetal blood transfusion operation conducted by Dr. Tabor and his team using the existing manual tools at the HMH. This experience revealed valuable information about the architectural requirements and engineering design of the CPMS-FBT. See Fig. 1 in the Attachment A.
  • Pump, syringes and connecting tubes, pressure sensor, flow-rate sensor, monitoring platform, and other software, hardware, and interfacing components (e.g.Portable PC, Analog to digital converter with USB connection to PC) were acquired.
  • Within the constraints of project’s budget, the system components were integrated, test-beds were set up, and laboratory tests were conducted at UTD, UTA, and HMH.

Panahi_Fetal Blood

Known Barries/problems to overcome:

  • Secure sufficient funding to enable acquisition of FDA approved pumps, sensors, and required components/tools.
  • A more advanced design to minimize the size and the foot print of the system is needed to ensure acceptability by the nurses and physicians. Also, there is a need for custom design and modification of the commercially-available components to allow greater automation and monitoring for ease of use and less errors.
  • Generate rich set of preliminary data for submitting proposal to federal funding agencies (NIH, etc.).

Lessons learned:

  • Our in-vitro testing of the system has shown the feasibility of automating the blood transfusion process.
  • System architecture, engineering design, and data communication, should be improved to meet all physical andmedical requirements of the operation room.

Publications, Patents filed, additional funding secured:

  • No patent has been filed yet. However, it is necessary to obtain at least patent disclosures as soon as possible.
  • Sufficient project’s results and data are already available to publish papers. However, a prior patent disclosure is needed.

Next Actions/Tasks:

  • To secure funding for continuation of the research project next year.
  • To complete system integration, and real time monitoring and control system.
  • To complete in-vitro and in-vivo testing.
  • To obtain FDA approved, especially designed platforms for the next year phase of the project.
  • To prepare and submit a proposal to federal agencies (e.g. NIH, DOD, etc.), and/or to industry, for securing sufficient funding.
  • To complete full development of prototype system and clinical testing suitable for manufacturing and commercialization of the system.

Full Presentation on Results

 

Issa M. S. Panahi, Ph.D., UTD, “Computerized Infusion and Monitoring System for Fetal Blood Transfusion” has been selected for funding in the amount of $100,000.

 

 

Primary Investigator:

 

Issa M. S. Panahi, PhD EE, UTD

Department of Electrical Engineering

issa.panahi@utdallas.edu // (817) 272-2708 // Biography

Team Members

Khosrow Behbehani, PhD, UTA

 Bannie Tabor, M.D., Texas Health Fort Worth medical staff

 

 

 

 

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