The CaVESWave® System
CaVESWave® - CardioVascular EmulationS Waveform System
An enabling technology organ and tissue studies and transplantation
Organs and tissues are needed to enable
medical research and save lives: A multifaceted problem in search of a solution
In hopes of understanding and conquering disease and preserving human lives, medical scientists have been studying isolated tissues and organs since The Renaissance. As early as 1628, the brilliant anatomist, physiologist, and physician William Harvey wrote, in the Dedication of his text De Motu Cordis (The Motion of the Heart), “The heart of animals is the foundation of their life,..”. Harvey understood that circulation, driven by the heart, keeps tissues and organs alive.
Inevitably, the scourges of aging and disease lead to tissue and organ failure and death. One method to prolong and improve life – organ transplantation - was described in literature dating from 600 BCE. Human blood transfusion, essentially a transplant of cells, has been commonly used to save lives since the 1930s. Solid organ and tissue transplantation has only been in common clinical use in the past sixty years.
Today, studies of cell cultures and small tissue explants are a mainstay in drug development and metabolism, in assessment of potential toxic effects of drugs and chemicals that humans and animals may be exposed to, and in understanding the basic workings of cells. However, information derived from these studies, while useful, rarely reflects (or predicts) the complex workings of most tissues and whole organs.
Preserving large tissues and organs outside the human body for longer that 24-48 hours is very difficult. This significantly limits physiologic, metabolic, and pharmacologic studies of tissue and organ function, hobbles the pace of medical research, and is a significant impediment to supplying sufficient numbers of organ transplants (kidneys, livers, heart, to name a few) to meet the staggering demand for these organs. To put this in perspective – fewer than 20% of patients with kidney failure ever receive a transplant. Many/most die while sustained with dialysis therapy - waiting for a transplant that cannot be provided.
A technology that facilitates tissue and organ preservation, a technology that allows dynamic measurements of living organ function outside the body – is desperately needed to overcome these problems and to enable medical research studies.
The CaVESWave® System
BioMedInnovations, LLC has developed and supplies a state-of-the-art, proven technology platform for medical research studies and studies of isolated organ function (including studies supporting transplantation). The “heart” of the system (borrowing from Harvey) is a patented, programmable perfusion waveform generator that, when coupled with flow controls, thermoregulation, and physiologic measurement instruments, provides precise (“cardioemulation”) perfusion of isolated tissues and organs for prolonged periods (up to 72 hours for whole kidneys and 24 hours for whole livers, for example). There are literally no other devices or systems on the market for tissue and whole organ studies that provide the type and level of sophisticated, complex perfusion delivered by the CaVESWave® System.
Validated CaVESWave® applications
Whole organ preservation studies (supporting transplantation and regenerative medicine)
· Preservation/viability of isolated, perfused kidney (>48 hours)
· Preservation/viability of isolated, perfused liver (12-24 hours)
· Physiologic studies of vascular integrity of scaffolded human kidneys
(for tissue regeneration)
· Preservation (in situ) of porcine brain for mapping of brain pathways
and perfusion fluid flow (ongoing)
· Preservation conditions required for vascular composite allografts
Analytical method development (for real-time studies of tissue function)
· Computational mapping of perfusion using surface infrared (SIR)
· Regional perfusion mapping using heat flux sensor devices
· Perfusion stream ‘liquid biopsy’ analytics
Medical device development (for treatment of cancer)
· Tissue ablation (liver) using pulsed electric fields (for removal of non-resectable tumors)
· Ablation probe engineering – monopolar, bipolar array, phase change probes
· Treatment planning/modeling for soft tissue ablation
Drug metabolism, pharmacology, kinetics studies (for drug development)
· Assessment of immediate hepatotoxicity following exposure to acetaminophen (ongoing)
· Modulation and control of hepatic circulation in normal and diseased livers with vasomotor drug therapy (in progress)
· Utilization of TCC staining for assessment of cell viability in isolated, perfused liver
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