Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Abstract: Embodiments provide apparatus and methods for producing markings in the skin. One embodiment provides an apparatus for marking the skin comprising a housing and reservoir for storing a skin colorant. An electrode is positioned within the housing so as to be electrically coupled to the colorant in the reservoir and is configured to be coupled to a current source and return electrode. A colorant applicator having at least one fluid pathway is coupled to a housing distal end. The applicator proximal end is positioned such that the fluid pathway is coupled with the reservoir. The applicator distal end applies colorant to the skin surface through the fluid pathway as the applicator is moved across the skin. The electrode delivers current from the current source to the skin to transport charged pigment elements of the colorant into the skin using an electromotive driving force to produce a marking in the skin.

Abstract: Embodiments provide apparatus and methods for delivering solid form medications such as pellets to various locations in the body. One embodiment provides an apparatus for in vivo delivery of medication pellets comprising a housing including a port, a pellet-containing belt disposed in the housing, and a mechanism for transferring the pellets from the belt to a delivery site (DS) outside the housing. Each pellet contains a dose of drug to treat a medical condition. An elongate member is coupled to the housing and includes a lumen for pellet delivery, a proximal end coupled to the port and a distal end positioned at the DS. The pellet can be delivered to the DS at regular intervals or responsive to a detected biological event. Embodiments of the invention are particularly useful for delivering medication to treat a medical condition over an extended period without requiring a patient to take external medication.

Abstract: Embodiments of the invention provide multi-stage biodegradable drug delivery platforms and methods for the subcutaneous delivery of therapeutic agents (TA). Embodiments of the platform may be configured to subcutaneously deliver a first dose of a first TA which is absorbed into the body and/or blood stream (BBS) to produce a first therapeutic effect for a first selectable time period (STP), and subsequently after a second STP, deliver a second dose of a second TA which is absorbed into the BBS to produce a second therapeutic effect for a third STP. An embodiment of the platform may comprise a body having a tissue-penetrating end, a primary cavity having a first TA dose and a shell having a secondary cavity having a second TA dose. The first TA dose is released after the first STP and the second TA dose is released after the second STP by biodegradation of the shell.

Abstract: Embodiments provide apparatus and methods for delivering solid form medications such as drug cords (DC) to various locations in the body. The DCs may comprise one or more drugs and excipients. One embodiment provides an apparatus for in vivo delivery of DCs comprising a housing including a port, a DC disposed in the housing on a spool or like device and a mechanism for advancing the DCs from the inside the housing to a delivery site (DS) outside the housing. The apparatus can be used to deliver selected lengths of DC corresponding to a dose of drug to treat a medical condition. The DC can be delivered to the DS at regular intervals or responsive to a detected biological event. Embodiments of the invention are particularly useful for delivering medication to treat a selected medical condition over an extended period without requiring a patient to take external medication.

Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Abstract: Embodiments of the invention provide compositions include bio degradable polymers, medical implants fabricated from these compositions and methods of using such implants. Many embodiments provide medical implants including a first polymer backbone having a first rate of biodegradation and a second polymer backbone having a second rate of biodegradation faster than the first rate. In some embodiments, the second backbone is configured to be replaced by a natural tissue layer. The first backbone provides a scaffold for the implant while the second backbone degrades. This scaffold can enhance mechanical properties of the implant including various aspects of mechanical strength such as tensile, bending, hoop and yield strength; and elasticity. The scaffold also serves to maintain a minimum level of structural support of the implant during the period of degradation of the second backbone or for the entire life of the implant so that the implant does not mechanically fail.

Abstract: Embodiments provide an apparatus, system, kit and method for in vivo measurement of blood oxygen saturation (BAS). One embodiment provides an implantable apparatus for measuring BAS comprising a housing, emitter, detector, processor and power source. The housing is configured to be injected through a tissue penetrating device into a target tissue site (TS). The emitter is configured to emit light into the TS to measure BAS, the emitted light having at least one wavelength (LOW) whose absorbance is related to a BAS. The detector is configured to receive light reflected from the TS, detect light at the LOW and generate a detector output signal (DOS) responsive to an intensity of the detected light. The processor is operably coupled to the detector and emitter to send signals to the emitter to emit light and receive the DOS and includes logic for calculating a BAS and generate a signal encoding the BAS.

Abstract: Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Abstract: Embodiments of the invention provide a system, apparatus and methods for underwater voice communication by a diver to other divers and surface ships. In many embodiments, the system includes a mouthpiece voice communication apparatus having a microphone for sensing the diver's voice and an acoustic transducer that conducts sound via conduction through the diver's teeth and skull to the cochlea so as to allow the diver to hear sounds. The mouthpiece is adapted to be easily attached to portions of a SCUBA or other underwater breathing apparatus. It may also be attached to or integral with a snorkel or similar apparatus.

Abstract: Embodiments of the invention provide an architecture, system and methods for optimizing power utilization for transdermal iontophoretic drug delivery which maintain a iontophoretic driving voltage at a reduced or even minimum value to support an iontophoretic delivery current. The reduced voltage reduces the power requirements for a transdermal iontophoretic delivery system during a period of drug delivery. Embodiments of an architecture for implementing this approach can utilize a controller which compares the desired current to the actual current and adjusts the voltage to reduce the amount of power used for iontophoretic drug delivery. The controller can comprise a state machine or microprocessor. Embodiments of the invention are particularly useful for extending the battery life of transdermal iontophoretic drug delivery systems.

Abstract: Embodiments of the invention provide shaped masses (SM) comprising one or more drugs such as proteins or polypeptides and methods for forming and delivering such SM's. One embodiment provides a SM comprising a drug e.g., a protein or polypeptide having a biological activity in the body of a mammal. The SM is formed by compression of a precursor material (PM) comprising the drug wherein an amount of biologically active drug in the SM is a minimum level to that in the PM. Drugs which may be incorporated into the SM include insulin, incretins and immunoglobulins e.g., interleukin neutralizing antibodies or TNF-?-inhibiting antibodies. Embodiments of the invention are particularly useful for the oral delivery of drugs which would be degraded within the GI tract, wherein the SM containing the drug is formed as or incorporated into a tissue penetrating member which is inserted into the intestinal wall after oral ingestion.

Abstract: Embodiments of the invention provide bio-reactor circuits for in vitro research applications. One embodiment provides a bio-reactor circuit comprising at least one bio-reactor and a pump fluidically coupled to the at-least-one bio-reactor. The bio-reactor comprises a housing having inlet and outlet ports and first and second chambers. The chambers are separated by a porous membrane with the first chamber providing a flow path for a fluid. The membrane includes a coating having a cell binding affinity for the attachment and proliferation of cells to cover the surface of the membrane. The second chamber provides a volume for maintaining the viability of cells disposed in the chamber. The cells can be selected to produce a biochemical compound. The membrane is configured to allow for diffusion of the compound from the second chamber into the flow path as well as allow for diffusion of gases, nutrients and other biochemical compounds.

Abstract: Embodiments of the invention provide apparatus, systems and methods for detecting neurological activity indicative of a dream state of a human. Many embodiments of the invention provide apparatus, systems and methods for detecting neurological activity of a human indicative of a dream state or the onset thereof and delivering an input to the user (such as an audio or other sensory input) during the dream state. Particular embodiments of the invention provide systems and methods for detecting neurological activity indicative of the onset or occurrence of a dream state of a human and delivering an audio or other sensory input during the user's dream state. The audio input may be used for learning, delivering messages to the user's subconscious, and/or promoting a state of relaxation.

Abstract: Embodiments of the invention provide systems and methods for generating and delivering electricity and/or hot water for combined heat and power (CHP) using one or more fuels. In many embodiments, the system can be used to provide efficient electrical, heating and cooling utilities to a residential household or group of households. Embodiments of the system can be configured for specific heat flow, while minimizing losses and maximizing total system efficiency. Embodiments also provide for stackable energy generation modules allowing the system to be placed in or nearby a residence to provide power to the residence. Embodiments also provide a control system which can be configured to monitor household electrical usage and dynamically regulate the system to operate at maximum efficiency as well as sell power to an external grid.

Abstract: Embodiments of the invention provide apparatus and methods for stimulating L cells in the intestinal tract to produce incretins for the treatment of conditions including diabetes and obesity. Many embodiments provide a method and apparatus for the treatment of diabetes by electrically stimulating L-cells to secrete incretins to stimulate or otherwise modulate the production of insulin. Particular embodiments provide a swallowable capsule for stimulating L-cells in the intestinal tract as the capsule moves through the tract. The capsule can include two or more electrodes for providing electrical stimulation to L-cells, a power source for powering one or more components of the capsule, a sensor for sensing the location of the capsule in the intestinal tract; a controller and a waveform generator for generating the electrical signals emitted by the electrodes to stimulate the L-cells to secrete incretins such as GLP-1 to stimulate insulin production for glucose regulation of diabetic conditions.

Abstract: Embodiments of the invention provide methods for detection and treatment of atrial fibrillation (AF) and related conditions. One embodiment provides a method comprising measuring electrical activity of the heart using electrodes arranged on the heart surface to define an area for detecting aberrant electrical activity (AEA) and then using the measured electrical activity (MEA) to detect foci of AEA causing AF. A pacing signal may then be sent to the foci to prevent AF onset. Atrial wall motion characteristics (WMC) may be sensed using an accelerometer placed on the heart and used with MEA to detect AF. The WMC may be used to monitor effectiveness of the pacing signal in preventing AF and/or returning the heart to normal sinus rhythm (NSR). Also, upon AF detection, a cardioversion signal may be sent to the atria using the electrodes to depolorize an atrial area causing AF and return the heart to NSR.

Abstract: Embodiments provide apparatus and methods for delivering solid form medications such as pellets to various locations in the body. One embodiment provides an apparatus for in vivo delivery of medication pellets comprising a housing including a port, a pellet-containing belt disposed in the housing, and a mechanism for transferring the pellets from the belt to a delivery site (DS) outside the housing. Each pellet contains a dose of drug to treat a medical condition. An elongate member is coupled to the housing and includes a lumen for pellet delivery, a proximal end coupled to the port and a distal end positioned at the DS. The pellet can be delivered to the DS at regular intervals or responsive to a detected biological event. Embodiments of the invention are particularly useful for delivering medication to treat a medical condition over an extended period without requiring a patient to take external medication.

Abstract: Embodiments provide an apparatus, system, kit and method for in vivo measurement of blood oxygen saturation (BAS). One embodiment provides an implantable apparatus for measuring BAS comprising a housing, emitter, detector, processor and power source. The housing is configured to be injected through a tissue penetrating device into a target tissue site (TS). The emitter is configured to emit light into the TS to measure BAS, the emitted light having at least one wavelength (LOW) whose absorbance is related to a BAS. The detector is configured to receive light reflected from the TS, detect light at the LOW and generate a detector output signal (DOS) responsive to an intensity of the detected light. The processor is operably coupled to the detector and emitter to send signals to the emitter to emit light and receive the DOS and includes logic for calculating a BAS and generate a signal encoding the BAS.

Abstract: Embodiments of the invention provide drug packaging and methods for producing drug packaging which can be sealed at room temperature and/or without the need for elevated temperatures above room temperature. Many embodiments provide drug packaging comprising pierceable tubing having a capsule shape (also referred to herein as a pierceable capsule and/or pierceable drug capsule) containing a solid drug such as a drug pellet and methods for producing pierceable drug capsules which can be sealed at room temperature. Embodiments are particularly useful for the packaging and delivery of drugs used in implantable drug delivery devices as well as packaging of drugs that are easily thermally degraded.