News Column

Patent Issued for Systems and Methods for an Advanced Medical Device

July 14, 2014

By a News Reporter-Staff News Editor at Cardiovascular Week -- According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventor Radojicic, Milan (Los Gatos, CA), filed on December 20, 2011, was published online on July 1, 2014 (see also Agathos Holdings LLC).

The assignee for this patent, patent number 8764697, is Agathos Holdings LLC (Newark, DE).

Reporters obtained the following quote from the background information supplied by the inventors: "The present invention relates to systems and methods for advanced medical devices, and in particular related to advanced cerebrospinal shunts, applications of shunt based therapies, and unique bioreactor designs that may mimic cerebrospinal environments with unprecedented accuracy. Such systems and methods provide for therapies that can treat disease states that were previously considered untreatable, increase the success of current cerebrospinal shunt treatments, and advance research into cerebrospinal pathology and physiology.

"Shunts have longstanding been utilized by the medical community to move fluid from one part of the body to another. For example in ventriculoperitoneal shunting, one or more catheters are placed unto the vertical of a patient's brain, and extend down to the abdominal or chest cavity (often into the peritoneal cavity). A pressure valve or fluid pump may attach to the catheter(s) in order to allow fluids to exit the brain if the pressure rises above desired levels. Additionally, the valve prevents backflow of blood or other fluids into the brain. There are many valve designs that may accomplish various flow characteristics.

"Typically shunt catheters are made of biocompatible materials, and are often selected based upon their final usage. Common shunt catheter materials include silicones, polyvinyl chloride (PVC), and latex rubber. Unfortunately, shunt failures may result from blockage of the proximal and/or distal catheters due to tissue ingrowth, cellular debris and clot, as well as shunt infection. Valve malfunctions are also possible. These frequent failures result in undue patient morbidity and mortality.

"In response to these complications frequently associated with traditional shunts, additional and more exotic shunt materials have been experimented with. These newer shunt materials have been designed to include bioactive compounds, such as antimicrobial compounds, anticoagulation, and protein degradation compounds. Some shunts have also been proposed that include bioactivity, such as seeded shunts and enzymatically active shunts.

"These newer shunt designs have come about for a variety of reasons, primarily related to buildup of protein, cellular debris, minerals, or other potential occlusions that negatively impact the flow characteristics of the shunt. While these advancements have been met with some degree of success, there is always a need for improved shunt designs that will provide long-term, cost effective, favorable flow characteristics in increasingly smaller luminal profiles.

"Additionally, new interest has developed in utilizing shunts as not only a fluid pathway, but also as a broader therapeutic tool. This may include adding in properties that extend beyond mere fluid flow, but also increase patient health.

"One area that has received particular interest is in cerebrospinal shunts. The diversion of cerebrospinal fluid from one location to another where it may be disposed is a well-known clinical strategy for a number of brain and spinal disorders, and is one of the most common neurosurgical procedures. Improving cerebrospinal shunt designs would have a marked impact upon a large number of patient's requiring this kind of procedure.

"The cerebrospinal fluid flow has two components. A bulk flow from the production and absorption of cerebrospinal fluid and a pulsatile/oscillatory flow from influence of the cardiac cycle on the bulk flow. Also, there are respiratory and body positional influences on the cerebrospinal fluid flow.

"With every heartbeat, a volume of blood enters the brain via the carotid and vertebral arteries, causing the brain to expand in the skull, which is a fixed container. This forces CSF out of the cranial cavity into the spinal subarachnoid reservoir, until diastole when the CSF is reversed. The CSF dampens the oscillations of the brain preventing injury. But in some CNS injury and disease the CSF production is diminished, so the pulse pressure (difference between systolic and diastolic pressures) can itself become an injurious process, the so-called pulse pressure encephalopathy.

"It stands to reason that the long acting pressure changes along with ventricular lining and spinal central canal can injure the endothelium, which is comprised on ependymal cell and subependymal stem cells. Ependymal cells produce and process the CSF. Specialized ependymal cells in association with a capillary network are known as the choroid plexus. Damage to the ependyma and choroid can influence CSF production and reduce the dampening effect of cardiac pulsations, as well the clearance of toxic ions, proteins and metabolites.

"Means for addressing the problems complacent with cerebrospinal shunts, replacement of CSF, and repair of cellular members that are involved in regulating the CSF environment could have significant clinical and research value.

"It is therefore apparent that an urgent need exists for an improved cerebrospinal medical device that enables more efficient and longer lasting fluid flow properties in a cerebrospinal shunt, improved therapies, and enhanced research into cerebrospinal pathologies and treatments."

In addition to obtaining background information on this patent, NewsRx editors also obtained the inventor's summary information for this patent: "To achieve the foregoing and in accordance with the present invention, systems and methods for an improved medical device is presented. Such systems and methods enable enhanced therapies, diagnostics, and research opportunities.

"In some embodiments, a biologically active medical device is provided which has a luminal surface and an abluminal surface. The medical device includes a matrix seeded with progenitor cells, and then covered by ciliated tissue. The matrix is capable of enabling cellular migration. The ciliated tissue is ependymal cells that express at least one of tight junctional complexes, zonula adherens, and gap junctions. The progenitor cells include subpendymal progenitor cells. In some cases the progenitor cells include stem cells, and the ciliated tissue includes at least one of Choroid cells, tanacytes, and circumventricular organs. In some embodiments, the medical device is oriented into a tubular structure in order to form a cerebrospinal shunt.

"Additional cells and structures may be imbedded within the matrix, such as glia, endothelial cells, stem cells, and blood vessels. The matrix may be made of silicones, polyurethane, polyethylene, polypropylene, polyvinyl chloride, agarose gel, collagen, elastin, capillary networks include fibronectin and endothelial cells.

"In some embodiments, the medical device as may also includes a microfluidic circuit coupled to the abluminal surface of the matrix. The medical device may also be incorporated into an anthropomorphic bioreactor. The anthropomorphic bioreactor includes a ridged outer surface for housing internal components, a flexible inner tube defining an anthropomorphically shaped lumen. The bioreactor also includes a series of ports that enable bulk flow control over fluid inside the lumen, as well as sensor access. An oscillating pump may also provide pulsatile flow of the fluid.

"Often, the fluid within the bioreactor is cerebrospinal fluid and/or synthetic cerebrospinal fluid. In some embodiments, the anthropomorphic bioreactor produces and processes the cerebrospinal fluid, including filtering the cerebrospinal fluid of a patient and mimicking disease states for research purposes.

"In some embodiments, such a bioreactor can be used to select for robust cells. This is accomplished by seeding the bioreactor with target cells, applying shear stresses to the target cells in a manner consistent with physiological conditions, maturing the cells, and collecting the cells. Only robust cells will survive, and as such the collected cells are more capable of surviving harsher conditions. In some cases the stresses applied include metabolic perturbations, temperature stresses, chemical stresses, osmolality stresses, radiation stresses, acoustic stresses, and electromagnetic stresses.

"Note that the various features of the present invention described above may be practiced alone or in combination. These and other features of the present invention will be described in more detail below in the detailed description of the invention and in conjunction with the following figures."

For more information, see this patent: Radojicic, Milan. Systems and Methods for an Advanced Medical Device. U.S. Patent Number 8764697, filed December 20, 2011, and published online on July 1, 2014. Patent URL:

Keywords for this news article include: Cardiology, Stem Cell Research, Agathos Holdings LLC.

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Source: Cardiovascular Week

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