Pre-Clinical Development of a Fetal Micropacemaker

Summary

Principal Investigator: Ramen Chmait
Abstract: DESCRIPTION (provided by applicant): We have developed a novel micropacemaker to address the critical problem of complete heart block in the fetus. This condition is a life-threatening emergency in a fetus, and is nearly always fatal if hydrops fetalis develops at a young gestational age. There are currently no effective treatment options in these cases, and attempts to implant an extra-uterine pacemaker with electrodes on the fetal heart have invariably failed due to lead dislodgement from fetal movement. The novel design is a self-contained single-chamber micropacemaker that can be percutaneously implanted into the fetus without exteriorized leads, allowing for subsequent fetal movement without risk of electrode dislodgement. Such a design and application is possible because of advances in fetal intervention that allow percutaneous placement of the pacing system through the maternal abdomen and fetal chest wall under ultrasound and fetoscopic guidance. With successful fetal pacing, a complete recovery from hydrops fetalis is expected with survival to term and a nearly normal life. A functional prototype of the device has been built, and animal testing using adult rabbits has provided compelling data regarding key aspects of the electronic and mechanical design strategies. In addition, the device was recently awarded a Humanitarian Use Device designation from the Federal Drug Administration. The next translational step of the project requires the successful implantation of a functional device into a fetal sheep to demonstrate proof of concept in a relevant pre-clinical animal model. A novel packaging system intended to protect the circuitry from bodily fluids will be developed and tested in vitro. The device will the be implanted in a series of fetal sheep, and ventricular stimulation of the fetal myocardium will be confirmed at regular intervals during gestation. The micropacemaker is powered by a tiny, commercially available, rechargeable lithium ion cell which can provide power for 2-3 weeks of pacing. Therefore, we will also design and build an inductive recharging system that allows the cell to be recharged weekly from outside the mother. This research project is only possible through a multidisciplinary collaboration among a team of investigators with diverse experience and skills. These range from device design and fabrication to knowledge of specific electrical and pacing properties of the developing heart to proficiency in fetal surgical interventions. Dr. Ramen Chmait is a fetal surgeon who has successfully and safely performed numerous surgical procedures and interventions on fetuses. Dr. Yaniv Bar-Cohen specializes in pediatric heart rhythm disorders and has expert knowledge of cardiac pacing devices. Dr. Gerald Loeb has extensive experience with miniature device technology and has previously developed an FDA-approved, injectable device to stimulate skeletal muscle. Dr. Michael Silka is a world-renowned pediatric electrophysiologist with expertise in pediatric heart rhythm disorders in fetuses. Dr. Ja Pruetz has unique expertise in fetal cardiac imaging and fetal cardiovascular physiology, which will be vital for the implantation and follow-up of the device. PUBLIC HEALTH RELEVANCE: Complete heart block in the fetus is a life-threatening emergency, and is nearly always fatal if hydrops fetalis develops at a young gestational age. There are currently no effective treatment options in these cases, and attempts to implant an extra-uterine pacemaker with electrodes on the fetal heart have invariably failed due to lead dislodgement from fetal movement. The goal of this research is to design, build and test a self-contained, battery-powered micropacemaker that can be percutaneously implanted into the fetus from outside the mother and recharged by radio waves as needed until delivery.
Funding Period: 2012-09-30 - 2015-08-31
more information: NIH RePORT

Detail Information

Research Grants30

  1. Microsensors to Study Electrical and Mechanical Coupling of Injured Myocardium
    Tzung K Hsiai; Fiscal Year: 2013
    ....
  2. MRI-Compatible Fiber-Optically Sensorized Biopsy Needles for Oncological Applicat
    BEHZAD MOSLEHI; Fiscal Year: 2013
    ..The proposed work will advance the field of smart needle development for robotic surgery with potentially broad-based spin-off applications in oncology, biological imaging and bioengineering. ..
  3. Development of the CircuLite Nano Pump and Infant Cannula System
    BRYAN PATRICK FRITZ; Fiscal Year: 2013
    ..The milestone for Phase II of the project will be delivery of an optimized Nano Pump and Infant Cannula System that has completed long-term animal studies. ..
  4. Optimizing Cardiovascular Device Thromboresistance for Eliminating Anticoagulants
    Danny Bluestein; Fiscal Year: 2013
    ..The technology offered will become an essential tool for manufacturers that seek to create, redesign and test a cardiovascular device. ..
  5. University of Maryland Greenebaum Cancer Center Support Grant
    Kevin J Cullen; Fiscal Year: 2013
    ..Reflecting our remarkable and continued growth, UMGCC seeks to renew its CCSG to enhance and expand its efforts in high-quality and clinically relevant cancer research. ..
  6. Mechanisms of PMN and Endothelial-Mediated Lung Inflammation and Injury
    Asrar B Malik; Fiscal Year: 2013
    ..abstract_text> ..
  7. Stem Cell-Based Therapies for Mitigation of Acute Radiation Syndromes
    Chandan Guha; Fiscal Year: 2013
    ..Project 3: Nanoparticle-based therapies for cutaneous radiation syndrome and Project 4: Mitigation of radiation damage by modulating inflammatory signaling pathways. ..
  8. Blood Pressure Regulation: Novel Roles for the Kidney
    Pablo A Ortiz; Fiscal Year: 2013
    ..Thus it will accelerate acquisition of knowledge of the novel mechanisms by which the kidney regulates blood pressure, and may provide new targets for anti-hypertensive drugs. ..
  9. Semi-volatile PCBs: Sources, Exposures, Toxicities
    Larry W Robertson; Fiscal Year: 2013
    ..These data and dietary studies in the last Aim will provide a scientific basis for risk assessment and advice for stakeholders with the ultimate goal to protect highly-exposed individuals and populations. ..
  10. A percutaneous cardiac implant to treat mitral valve regurgitation
    Michael Lesh; Fiscal Year: 2013
    ..Our long- term goal is approval by the FDA for commercial sale within the US via the Premarket Approval process. ..
  11. Fabrication of 3D Cardiac Patches for Myocardial Recovery
    RAVI KUMAR BIRLA; Fiscal Year: 2013
    ..abstract_text> ..
  12. Apical Access System with Universal Connector for Beating Heart LVAD Implantation
    Jorge Hernan Jimenez; Fiscal Year: 2013
    ..Ultimately, clinical acceptance to treat earlier stage HF patients and expansion into global markets can be achieved. ..
  13. Synchronous Valveless Pulsatile Support Device for the Failing Heart
    RICHARD WARREN SMALLING; Fiscal Year: 2013
    ..We believe that our technology has the potential to improve patient quality of life while minimizing complications compared to currently available LVADs. ..
  14. An Enabling Technology for Improving Engraftment of Implanted Materials and Cells
    Michael J Yost; Fiscal Year: 2013
    ..It is our aim to develop an enabling technology that promotes scar-free healing after surgery of implanted biological and synthetic materials in the human body. ..
  15. Counterpulsation Device with Integrated EKG System for Chronic Partial Circulator
    Paul A Spence; Fiscal Year: 2013
    ..The additional advantage of low cost (due to simplicity of design and a limited operative approach) may further expand the use of mechanical support with this device to currently large, unrealized, global markets. ..
  16. Diverse Roles of Reactive Oxygen Species and Inflammation in Vascular Disease
    Kathy K Griendling; Fiscal Year: 2013
    ..Ultimately, this research may establish new unifying concepts linking conditions that alter vascular oxidant stress and inflammation to the molecular processes underlying vasculopathies. (End of Abstract) ..
  17. Therapeutic Microlesioning by Contrast Echocardiography for Myocardial Reduction
    Oliver D Kripfgans; Fiscal Year: 2013
    ..This innovative technology will advance medical ultrasonics and improve significantly the prognosis for patients living with life-threatening myocardial hypertrophy. ..
  18. Micro-technology Enhanced Pediatric Lens Capsulotomy Device
    Christopher Keller; Fiscal Year: 2013
    ..Results from this Phase II work will allow us to advance to device certification by good laboratory practice (GLP) accredited facilities as required for clinical trial initiation and ultimte FDA approval. ..
  19. Ultra Low Power Integrated Circuits and Systems for Cardiac Pacemakers
    Eugene B John; Fiscal Year: 2013
    ..The fabricated integrated circuits will be tested for functional correctness and for the desired electrical characteristics. ..