Invented by Brett R. Blackman, Brian R. Wamhoff, Ajit Dash, Michael B. Simmers, Ryan E. Feaver, Hemoshear LLC

In vitro models of pathological and physiological conditions have become increasingly popular in recent years. These models are used to study diseases and conditions in a controlled environment, allowing researchers to better understand the underlying mechanisms and develop new treatments. The market for in vitro models of pathological and physiological conditions is growing rapidly, driven by the increasing demand for more accurate and efficient research tools. One of the key drivers of this market is the need for more accurate and predictive models of disease. Traditional animal models have limitations, including differences in physiology and metabolism between animals and humans. In vitro models, on the other hand, can be designed to closely mimic human physiology and disease processes, allowing for more accurate predictions of drug efficacy and toxicity. Another factor driving the growth of this market is the increasing availability of advanced technologies for creating and studying in vitro models. Advances in tissue engineering, microfluidics, and imaging technologies have enabled researchers to create more complex and realistic models of disease, and to study these models in greater detail than ever before. The market for in vitro models of pathological and physiological conditions is also being driven by the growing focus on personalized medicine. As researchers gain a better understanding of the genetic and molecular basis of disease, there is increasing interest in developing models that can be tailored to individual patients. In vitro models can be used to test the efficacy of drugs and other treatments on patient-specific cells, allowing for more personalized and effective treatments. Overall, the market for in vitro models of pathological and physiological conditions is expected to continue growing in the coming years. As researchers continue to develop more advanced and realistic models, and as the demand for personalized medicine increases, the market for these tools is likely to expand even further. This is good news for patients, who stand to benefit from more accurate and effective treatments, and for researchers, who will have access to better tools for studying disease and developing new therapies.

The Hemoshear LLC invention works as follows

The invention generally refers to in vitro methods of mimicking in vivo pathological and physiologic conditions. These methods involve applying shear force to a type of cell or cell type that has been plated on a surface in a cell culture container. These systems can also be used to test drugs and compounds.

Background for In vitro model of pathological and physiologic conditions

Conventional in vitro models for pathological or physiological conditions typically involve the cultivation of one or more cell types under static conditions. These models often require the addition of factors at much higher concentrations than what is observed in vivo under the physiological or pathological condition. To maintain hepatocytes in static tissue cultures, insulin and glucose must both be present in culture media at concentrations that are significantly higher than those observed in vivo in healthy individuals. TNF levels are also significantly higher in static monocultures of endothelial cell monocultures used to model thrombosis. Fibrin deposition is required at levels that are higher than those found in human blood.

Moreover, conventional systems are not able to respond to drugs or compounds at the concentrations required to incite the same response in vivo. They require much higher levels of the drug or compound.

The present invention addresses a method for mimicking a pathological condition, in vitro. This involves adding culture media to a cell media container, adding at most one factor to that media, plating at minimum one cell type on at the least one surface of the cell culture container and applying a shear for the at least one plate cell type. The flow of culture media through a flow device causes the shear force. The flow is similar to that of a pathological condition in which at least one type of cell is exposed in vivo. The in vivo concentration of the factor can be found in the culture media. Alternativly, the factor’s concentration in culture media could be within the range of what would occur in vivo after administration of a drug/compound.

Another aspect is the in vitro method for testing a drug/a compound’s effect on a disease. This involves mimicking the disease condition and adding the drug or compound to the culture media. Then, apply the shear force to at least one of the plated cells that has been exposed to the drug/compound. The presence of the compound or drug results in a change in at least one type of plated cell. The in vitro method for mimicking a disease can be used to mimic the pathological condition in this in vitro test of a drug or compound.

The present invention provides an in vitro method for testing a drug/compound for its effect. This involves adding culture media to a cell media container, plating at most one cell type on the cell media container, and adding a drug/a compound to that media. Finally, applying a shear force to at least one of the plated cells to the compound or drug. The drug or compound concentration in the culture media is within the range of the drug/compound that causes the effect in vivo. A flow device causes the media to flow. The flow is similar to that of a cell type being exposed in vivo. The drug or compound causes a change in at least one of the plated cell types in response to the drug. An effect could be either a physiologic or pathological condition.

Another aspect is the invention’s method of imitating physiologic conditions in vitro. This method involves adding culture media to a cell media container, adding at most one factor to that culture media, plating at minimum one cell type on at the least one surface of the cell culture container and applying a shear for the at least one plate cell type. The flow of culture media through a flow device causes the shear force. The flow is similar to that of physiologic conditions in which at least one type of cell is exposed in vivo. The in vivo concentration of the factor can be found in the culture media. Alternativly, the factor’s concentration in culture media could be within the range of what would occur in vivo after administration of a drug/compound.

The present invention also addresses an in vitro method for testing a drug or compound for its effect on a physiological condition. This involves mimicking the physiologic conditions, adding a drug to the culture media and applying shear force to at least one type of plated cells that have been exposed to the drug. The presence of the drug/compound will cause a change in at least one type of plated cell. This in vitro method for testing a drug/compound can mimic the physiologic conditions using the in vitro method to mimic the physiologic conditions as described above.

Another aspect is the ability to mimic a pathological condition or physiological condition of the liver in vitro. This involves adding culture media to a cell media container, adding at most one factor to that media, plating at minimum one type of hepatic cells type on at least 1 surface within the container, and applying shear force to at least one plated type of hepatic cells type. The flow of culture media through a flow device causes the shear force. The flow mimics the flow in which at least one type of hepatic cells is exposed in vivo under a pathological or physiological condition. The in vivo concentration of the factor can be found in culture media to mimic the pathological condition. Alternately, the concentration of the element in the media may be within the range of what would occur in vivo after administration of a drug. Another alternative is that the culture media concentration can be sufficient to maintain the mimicked pathological conditions in vitro for a time under shear force. However, it may not be able to sustain the same level of shear force for the same time. The in vivo concentration of the factor that mimics the physiologic conditions can be found in the culture media. Alternately, the concentration of the element in the media may be within the range of what would occur in vivo if a drug or compound was administered to it. Another alternative is that the factor can be maintained in vitro in a controlled manner by the culture media. However, this will not allow for the maintenance of the mimicked physiological condition in vitro over time without the shear force.

The present invention provides an in vitro method for testing a drug or compound’s effect on a physiological or pathological condition. This involves mimicking the physiological or pathological condition and adding a drug to the culture media. Then, apply the shear force to at least one type of plated liver cell that has been exposed to the drug. The presence of the drug/compound in the culture media will cause a change in at least one type of plated liver cell. This indicates that the drug or compound is having an effect on the physiological or pathological condition. This in vitro method for testing a drug/compound can mimic the physiological or pathological conditions as described in the preceding paragraph.

Another aspect is to mimic a pathological condition or physiological condition of the liver in vitro. This involves adding culture media to a cell-culture container, depositing at most one extracellular mat component on a surface of the cell-culture container, plating liver cells on the at minimum one extracellular mat component, and then indirectly applying a shear force to the at least 1 extracellular matrix and the hepatocytes. The flow of culture media is induced by a flow device, which results in the shear force. The flow is similar to the flow to which the hepatocytes in vivo are exposed in physiologic or pathological conditions.

The invention also offers another way to mimic a pathological condition or physiological condition of the liver in vitro. This involves adding culture media to a cell-culture container and plating liver cells on a first porous membrane surface. The porous membrane is suspended within the cell culture container so that its first surface is located proximal to the bottom of the container. This creates a container with a lower volume which contains the hepatocytes, and an upper volume that includes the porous membrane’s second surface. The second porous membrane’s surface is subject to a shear force in the container’s upper volume. This shear force is caused by the flow of culture media. The flow simulates the flow to which the hepatocytes in vivo are exposed in physiologic or pathological conditions. The flow device consists of a body that can be placed in the culture media within the container’s upper volume and a motor that rotates the body.

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