Medical devices and uses thereof
The present invention provides for a method and apparatus for inserting and using dermal interstitial sensors in, for example, an analyte monitoring system, and for injecting active pharmaceutical ingredients, a bio-artificial organ device, and detection of a protein biomarker.
1. A bio-artificial organ device for processing of a biological fluid for the production of a biologically active, physiologically sustainable tissue comprising:
an inflow port for ingress of a biological fluid;
a distribution chamber which optionally includes a pump;
at least one column in fluid communication with the distribution chamber having a cap wherein said at least one column can receive biological fluid flow from the inflow port, wherein said at least one column comprises a decellularized, de-vitalized extracellular matrix derived from a non-micro organ source selected from the group consisting of either neonatal porcine or human liver, adult porcine or human liver, neonate porcine or human pancreas, adult porcine or human pancreas, and combinations thereof, further wherein said at least one column comprises a living cellular component selected from the group consisting of hepatocytes, hepatobiliary progenitor cells, hepatobiliary stem cells, pancreatic islet beta cells, pancreatic stem cells, and combinations thereof;
wherein said column has one or more sensors that monitor said column for metabolic and functional activity;
wherein when there are more than one column, the columns are independent from each other;
a holding device surrounding an entirety of an axial surface of the at least one column and configured so as to allow insertion into the holding device and removal from the holding device of the at least one column, and wherein the at least one column is attached to the distribution cap with a column connector;
a sealingly closeable outer casing;
a thermal control system including a thermos-pouch encasing the bio-artificial organ which maintains the device at an optimal temperature for the cells within the device;
the function of the bio-artificial organ may be controlled by control units selected from the group consisting of dedicated sensors, micro-controllers, wireless communication systems, micro actuators, contactless identification tags and combinations thereof;
an outflow port for egress of a biological fluid,
wherein said bio-artificial organ conducts and processes said biological fluid; and
the device is adapted to hold approximately 500-700 grams of cellularized tissue in order to provide sufficient tissue function to keep the body in homeostasis.
2. The bio-artificial organ device of claim 1 for processing of a biological fluid, comprising:
an apparatus external to a patient which is in communication with the one or more sensors and wherein the external apparatus is selected from the group consisting of one or more of a display, monitor, printer, computer, wireless device and global positioning device;
wherein the device is configured to be implanted in a patient;
a living cellular compound selected from the group consisting of cells from human, porcine, or other mammals, and combinations thereof; and
the living cellular component is derived from a source selected from the group consisting of fetal human liver, neonatal human liver, fetal pediatric human liver, teenage human liver, adult human liver, fetal human pancreas, neonatal human pancreas, pediatric human pancreas, teenage human pancreas, adult human pancreas, cultured human hepatocytes, cultured human beta cells, stem cells derived hepatocytes, stem cells derived beta cells, human pancreatic stem cells, adult or pediatric human hepatobiliary stem cells, adult or pediatric human hepatobiliary progenitor cells and combinations thereof; or from the group consisting of fetal porcine liver, neonatal porcine liver, fetal pediatric porcine liver, teenage porcine liver, adult porcine liver, fetal porcine pancreas, neonatal porcine pancreas, pediatric porcine pancreas, teenage porcine pancreas, adult porcine pancreas, cultured porcine hepatocytes, cultured porcine beta cells, stem cells derived hepatocytes, stem cells derived beta cells, porcine pancreatic stem cells, adult or pediatric porcine hepatobiliary stem cells, adult or pediatric porcine hepatobiliary progenitor cells or combinations thereof.
3. The bio-artificial organ device of claim 1 for processing a biological fluid,
wherein the one or more sensors are capable of wireless communication;
the biological fluid is blood or plasma;
the inflow port and outflow ports are attached to a central blood line configured to recirculate blood to the subject;
the device contains units selected from the group consisting of an independent redundant battery power system, a hydraulic system, the thermal control system, and combinations thereof; and
the thermal control system keeps the bio-artificial organ at a constant temperature;
the one or more sensors can be used to monitor blood values before and after the columns selected from the group consisting of including but not limited to glucose levels, electrolytes, sodium, potassium, chloride, bicarbonate, pH, oxygenation level, ammonia level, lipid levels, the speed and cumulative volume of flow of the blood, temperature, blood pressure, and combinations thereof; and
the one or more sensors can be used to monitor blood values selected from the group consisting of hematocrit, iron saturation concentration, red blood cell balance, and combinations thereof;
the one or more sensors can alert clinical staff overseeing the use of the devices for deviations from normal that may require adjustment of the device or additional diagnostics or therapeutic adjustments for the patient;
the one or more sensors can detect identified toxins selected from the group consisting of prescription medications, over the counter medications, herbal remedies, dietary supplements, ingested or topical toxins, environmental toxins, bio-threats, chemical weapon threats, and combinations thereof;
the one or more sensors can detect infectious agents selected from the group consisting of bacterial, viral, fungal, parasitic, and combinations thereof;
the one or more sensors can detect molecular or cellular breakdown of infectious agents selected from the group consisting of endotoxins, organism membrane fragments, membrane associated vesicles, and combinations thereof;
the device has a central blood line out and a central blood line in;
the blood flow can be arterial derived, venous derived, and combinations thereof;
the blood flow can come from an implanted or surgically created fistula,
the venous blood flow is propelled by gravitational force and low pressure of the venous system; and
the arterial blood flow is propelled through arterial blood pressure with or without gravitational force.
4. The bio-artificial organ device of claim 1 for processing of a biological fluid, wherein the matrix has a thickness of at least about 1 millimeter.