Abstract: Techniques related to temporary setpoint values are disclosed. The techniques may involve causing operation of a fluid delivery device in a closed-loop mode for automatically delivering fluid based on a difference between a first setpoint value and an analyte concentration value during operation of the fluid delivery device in the closed-loop mode. Additionally, the techniques may involve obtaining a second setpoint value. The second setpoint value may be a temporary setpoint value to be used for a period of time to regulate fluid delivery, and the second setpoint value may be greater than the first setpoint value. The techniques may further involve causing operation of the fluid delivery device for automatically reducing fluid delivery for the period of time based on the second setpoint value.

Abstract: The present disclosure provides vaccine compositions comprising at least one adjuvant and at least one antigen, wherein the adjuvant is a cationic lipid. The disclosure also provides methods of treating a disease in a mammal, methods of preventing a disease in a mammal, and methods of effecting antigen cross presentation to induce a humoral immune response and a cellular immune response in a mammal utilizing the vaccine compositions. Cross presentation of various antigens can be achieved by formulating the specific antigens with cationic lipids possessing adjuvant properties.

Abstract: A user-mountable electronic device includes a housing, an accelerometer located within the housing, and at least one processor located within the housing. The accelerometer measures acceleration of the user-mountable electronic device and is configured to generate an output in response to detecting acceleration of the user-mountable electronic device that is greater than a minimum acceleration threshold. The at least one processor controls operation of the user-mountable electronic device. The at least one processor is configured to receive the output generated by the accelerometer and, in response thereto, to transition from a dormant or standby state of the user-mountable electronic device to an active state of the user-mountable electronic device.

Abstract: A method is disclosed for preparing a soft tissue site, and augmenting the soft tissue site, such as the breast(s), scar, depression, or other defect, of a subject through use of devices that exert a distractive force on the breast(s) and grafting of autologous fat tissue such as domes and sealing rims for surrounding each of the soft tissue site and a regulated pump. The method for preparing the soft tissue site, and enhancing fat graft results, entails application of the distracting force to the targeted soft tissue site at least intermittently for some period of time and preferably several weeks prior to the graft procedure. A rotated aspect of the invention includes following the preparation steps by transfer of fat from other areas of the subject to the subject's soft tissue site, and then reapplication of the distractive force to the soft tissue site that received the autologous fat graft.

Abstract: A fluid channel module for an infusion set component of a fluid infusion device that delivers a fluid to a patient includes a body section comprising coupling features to mate with a base of the infusion set component. The fluid channel module includes an interior fluid flow channel formed within the body section to receive the fluid from the fluid infusion device. The fluid channel module includes a conduit having a first end in fluid communication with the interior fluid flow channel, and having a second end to deliver the fluid to the patient.

Abstract: A fluid infusion system includes a housing configured to be adhesively coupled to an anatomy of a user, and a tube configured to extend from the housing for insertion into the anatomy of the user. The tube includes a plurality of conduits defined within the tube. The plurality of conduits include a fluid delivery conduit configured to facilitate a fluidic connection between a fluid source and the anatomy of the user, and one or more conduits configured to accommodate a plurality of electrodes for determining a physiological characteristic of the user.

Abstract: A method may include receiving, from a volume meter at a pump configured to deliver medication to a patient, data indicative of a volume of a medication present in a syringe inserted in the pump. A first counter may be updated, based on the data, in response to the medication being delivered to the patient as a first dose type. A second counter may be updated, based on the data, in response to the medication being delivered to the patient as a second dose type. The volume of the medication delivered to the patient may be determined based on the first counter and/or the second counter. An electronic alert may be sent to a mobile device in response to one or more anomalies being present in the volume of the medication delivered to the patient. Related methods and articles of manufacture, including apparatuses and computer program products, are also disclosed.

Abstract: An invaginating device includes an inner elongate member and an outer flexible tube with invaginated axial ends. The outer flexible tube is: disposed at a first axial end of the inner elongate member; concentric with the inner elongate member; sized to provide a radial gap there between; sealably connected at the axial ends of the outer flexible tube to the inner elongate member, with the axial spacing between such sealed axial ends being less than the axial length of the outer tube; and extendable to protrude from the first axial end of the inner elongate member and retractable to reduce such protrusion from the first axial end of the inner elongate member. Fluid contained within the radial gap defined between the inner elongate member and the outer flexible tube is either pressurized or a non-compressible fluid.

Abstract: Lysis devices, methods, and systems are disclosed including a lysis device comprising a sample vessel having an outer surface, a microchannel within the confines of the outer surface, a first port extending through the outer surface to the microchannel, and a second port extending through the outer surface to the microchannel; and an acoustic transducer bonded to the outer surface of the sample vessel to form a monolithic structure, the acoustic transducer configured to emit ultrasonic acoustic waves into and/or to induce shear forces into a blood sample within the microchannel, thereby rupturing the blood cells.

Abstract: This patent application relates generally to the treatment of cancer, and more particularly to the use of a pseudotyped lentivirus expressing IL-12 for the treatment of cancer.

Abstract: Dermal filling materials and techniques are disclosed herein. In particular, dermal fillers containing low melt agarose (i.e., agarose having a melting temperature of less than 65° C.) are described. The disclosed dermal fillers can be manipulated after injection by, for example, heating and/or cooling the dermal filler while inside the patient to adjust its positioning or stiffness.

Abstract: This disclosure generally relates to methods for reducing the risk of preterm birth in a pregnant human female patient that include subcutaneous administration of HPC. The disclosure relates in part to the discovery that subcutaneous administration of HPC is actually feasible and can result in sufficient plasma levels of HPC in pregnant patients that can reduce the risk of preterm birth.

Abstract: In one aspect, methods of treating a wound are described herein. A method described herein, in some embodiments, comprises treating a wound, such as a chronic wound, by performing a full field laser ablation in a wound bed of the wound and subsequently performing a fractional laser ablation in the wound bed. Additionally, in some cases, the fractional laser ablation step is carried out at substantially the same time as, or immediately following, the full field laser ablation step. In addition, in some instances, a method described herein further comprises performing debridement in the wound bed prior to performing the full field laser ablation in the wound bed.

Abstract: The present application relates to methods of treating HIV-associated nephropathy (HIVAN) and/or focal segmental glomerulosclerosis (FSGS) using endothelin-1 (ET-1) antagonists. The application further relates to a composition for the treatment of HIVAN and/or FSGS. A kit for detecting the presence of ET-1 or ET-1-associated biomarker in a biological sample is also disclosed.

Abstract: This disclosure generally relates to methods for reducing the risk of preterm birth in a pregnant human female patient that include subcutaneous administration of HPC. The disclosure relates in part to the discovery that subcutaneous administration of HPC is actually feasible and can result in sufficient plasma levels of HPC in pregnant patients that can reduce the risk of preterm birth.

Abstract: The present invention relates to a chamber for a blood treatment system with at least one space defined by a chamber wall and with at least one blood inlet and with at least one inlet for a further fluid, which are connected with the space, wherein both the at least one blood inlet and the at least one inlet for the further fluid are formed on tube sections which protrude into the space of the chamber, wherein in the operating condition of the chamber the space of the chamber is at least partly filled with blood or with a mixture of blood and the further fluid or some other fluid and wherein at least one, preferably both or a plurality of the tube sections have a length such that the blood inlet and/or the inlet for the further fluid are located below the blood or fluid level in the chamber.

Abstract: This disclosure generally relates to methods for reducing the risk of preterm birth in a pregnant human female patient that include subcutaneous administration of HPC. The disclosure relates in part to the discovery that subcutaneous administration of HPC is actually feasible and can result in sufficient plasma levels of HPC in pregnant patients that can reduce the risk of preterm birth.

Abstract: In the method for producing at least one therapeutically effective protein or a protein mixture in a container, the container is filled with a body fluid and gold particles and incubated, and in this process the therapeutically effective protein is formed in the body fluid.

Abstract: The invention relates to a method of treating tumor cells within a patient wherein immature dendritic cells developed from the patient's monocyte cells and a lymphocyte cultured medium (LCM) adjuvant are introduced into the patient directly into the patient's tumor cells. The immature dendritic cells and LCM adjuvant combine with the antigens in the tumor cells to form a cancer vaccine, thereby immediately treating the tumor cells of the patient. The invention also provides a precursor treatment step of treating the patient with radiation therapy or a chemotherapy regimen.

Abstract: In accordance with one aspect, an instrument is provided that permits the precise delivery of bone fusion material, such as autograft or allograft material, to one or more bones during surgical procedures. In another aspect, a system and a method are also provided for percutaneous delivery of bone fusion material, such as morselized autograft or bone graft, in a minimally invasive approach through one or more relatively small incisions in a patient. In yet another aspect, an expansion device is provided having an internal compartment and being shiftable between an insertion configuration and an expanded configuration. Bone fusion material may be injected into the internal compartment of the expansion device and travel therealong for bonding to one or more bones approximate the expansion device.

Abstract: A method is disclosed for preparing a soft tissue site, and augmenting the soft tissue site, such as the breast(s), scar, depression, or other defect, of a subject through use of devices that exert a distractive force on the breast(s) and grafting of autologous fat tissue such as domes with sealing rims for surrounding each of the soft tissue site and a regulated pump. The method for preparing the soft tissue site, and enhancing fat graft results, entails application of the distracting force to the targeted soft tissue site at least intermittently for some period of time and preferably several weeks prior to the graft procedure. A related aspect of the invention includes following the preparation steps by transfer of fat from other areas of the subject to the subject's soft tissue site, and then reapplication of the distractive force to the soft tissue site that received the autologous fat graft.

Abstract: A delivery system comprising a biodegradable single or multi compartment covering is provided. The covering can be a mesh bag including a pre-attached detachable holding member surrounding the opening of at least one compartment and a pre-attached removable filling member configured to fit within the opening of the at least one compartment. The opening of the bag can include a closing member. The pre-attached detachable holding member can be a collar including finger grips and is used to hold the bag in one position while filling it. In some embodiments, the pre-attached detachable filling member can be a funnel for loading the mesh bag with bone graft material. Once the covering is filled, the holding member and filling member can be removed and the covering is closed with a closing member such as a drawstring. A method of treatment utilizing the delivery system is also provided.

Abstract: A method and apparatus for thawing and delivery of cryogenically frozen biological material, such as stem cells includes a housing for receiving a pouch of frozen cells, a heating element against which the pouch is placed for applying defrosting heat to the pouch, and a squeezing apparatus for applying a squeezing force to the pouch after or upon thawing of the cells. The squeezing force may be applied by a roller pressing the pouch against the heating element, which forces the thawed cells from a needle or tube connected to the housing and/or to the pouch. A rechargeable battery in the housing supplies power to the heating element and the squeezing apparatus.

Abstract: Human hepatocyte cell cultures and their use in bioreactors and bioartificial liver (BAL) systems are provided. The cells have constitutive liver-specific metabolic activity resembling that of freshly isolated human hepatocytes. The hepatocyte cells and BAL systems can be used to treat patients suffering from acute liver failure, end-stage liver disease, or acute-on-chronic liver disease.

Abstract: The present invention provides muscle-derived progenitor cells that show long-term survival following transplantation into body tissues and which can augment soft tissue following introduction (e.g. via injection, transplantation, or implantation) into a site of soft tissue. Also provided are methods of isolating muscle-derived progenitor cells, and methods of genetically modifying the cells for gene transfer therapy. The invention further provides methods of using compositions comprising muscle-derived progenitor cells for the augmentation and bulking of mammalian, including human, soft tissues in the treatment of various functional conditions, including malformation, injury, weakness, disease, or dysfunction. In particular, the present invention provides treatments and amelioration for urinary incontinence and other urinary tract pathologies.

Abstract: Implantable devices and methods for delivering pharmaceutical substances into a patient. The implantable device includes the following components: (a) an implant body, (b) a reservoir in the implant body, (c) a heterogeneous composition disposed in the reservoir, which includes a pharmaceutical substance in the solid state contacted by a solution of the pharmaceutical substance, and (d) a nanochannel membrane for delivering the pharmaceutical substance from the reservoir to a patient. Extended, high-quality delivery of low solubility drugs such as hormones and chemotherapeutic agents are achieved.

Abstract: A method of providing a pancreatic, lymphoid/hematopietic or pulmonary organ and/or tissue function to a mammalian subject is provided. The method comprises transplanting into the subject a developing mammalian pancreatic, lymphoid/hematopietic or pulmonary organ/tissue graft, respectively, thereby generating a functional pancreatic, lymphoid/hematopietic or pulmonary organ and/or tissue, respectively, for providing the pancreatic, lymphoid/hematopietic or pulmonary organ and/or tissue function, respectively, to the subject.

Abstract: A system for mixing and dispensing at least first and second components of a biomaterial. The system includes a first syringe including a barrel having a proximal and distal ends. The barrel is configured to receive the first and second components of the biomaterial. There is a cap on the distal end of the barrel. The cap has an opening to allow materials to be directed into the barrel. The system further includes a mixing member. At least a portion of the mixing member is configured to enter the barrel through the cap. The mixing member is configured to move at least axially within the barrel to mix the first and second components.

Abstract: A bioreactor is provided which contains cells capable of producing cytokine inhibitors in response to cytokines, in a manner regulated by the local or systemic milieu of an individual patient and predicted by mechanistic computational simulations. The bioreactor transfers the cytokine inhibitors to a patient in need of control of the inflammation process as part of a disease or condition in the patient, such as sepsis, trauma, traumatic brain injury, or wound healing. Related methods also are provided.

Abstract: The containment and fixation system of the present invention generally includes a biomatrix sleeve, biomatrix particles or combinations thereof made of a biomatrix material. The biomatrix material is comprised of one or more biocompatible proteins and one or more biocompatible solvents. The biomatrix material utilized in the sleeve and/or particles may also include one or more pharmacologically active agents like therapeutic biochemicals such as a bone mending biochemical (e.g. hydroxyapatite) or an angiogenic growth factor (e.g. BMP).

Abstract: An endoluminal medical access device (1) is disclosed that is devised for endoluminal delivery to an extravascular target site (5) at a vasculature site of a human or animal body vasculature, such as the microvasculature.

Abstract: This document discusses, among other things, an apparatus comprising a pump configured to deliver a fluid from a cartridge, a display a temperature sensor and a controller. The controller is configured to compare a temperature within the cartridge as measured by the temperature sensor to a threshold temperature and cause the display to display a message relating to temperature when the measured temperature goes beyond the threshold temperature.

Abstract: A medical device configured for diagnosis or treatment of tissues within a body is provided. The device includes an elongate, deformable member configured to be received within a lumen in the body and having proximal and distal ends. A position sensor is disposed at the distal end. In one embodiment, a conductor is wound about the member. The conductor is connected to the position sensor and has a first winding pitch over a first portion of the deformable member and a second winding pitch, different from the first winding pitch, over a second portion of the deformable member. In another embodiment, the member defines a neutral longitudinal axis extending between the proximal and distal ends. A conductor extending between the proximal and distal ends is connected to the position sensor at a connection node on the neutral axis.

Abstract: A cell culture transferring instrument includes a cylindrical body held by an operator not shown in the drawing, a plunger inserted through the interior of the cylindrical body, a plurality of support members connected to a distal end of the plunger, and an adsorbent capable of adsorbing a sheet-shaped cell culture held by the support members. The support members in contact with the distal end of the cylindrical body are elastically deformed by displacing the plunger toward the proximal end side with respect to the cylindrical body in a state in which the sheet-shaped cell culture is adsorbed to the adsorbent, whereby the adsorbent and the sheet-shaped cell culture are deformed and housed in a housing hole in the cylindrical body.

Abstract: Apparatuses, systems, and methods for enhancing bone or soft tissue regeneration are provided. For example, a conduit, having one or more segments, can originate at a tissue regeneration site and can have a first opening to promote physiological signals to enter the conduit and transit to a second opening that penetrates a histologically rich source of multipotent mesenchymal cells, promoting the multipotent mesenchymal cells to produce tissue regeneration response products, the response products transiting through the second opening to egress at the first opening of the conduit, and promoting tissue regeneration at the tissue regeneration site. Transit of the physiological signals and the tissue regeneration response products is promoted through physical and/or chemical means, as is promotion of the anatomical functionality of the regenerated tissue. For example, a number of the segments of the conduit can be formed at least partially from an osteoceramic material.

Abstract: Systems and methods for the treatment of a joint are provided. These systems and methods may also include a subchondral treatment of bone of the same joint. These joint treatment methods may be non-surgical or surgical. Also provided are devices and instruments associated with the methods.

Abstract: A method for administering a barrier cell treatment for malignant or benign tumor cells. The method includes preparing a material including chondrocytes and placing the material around the tumor cells. Preparing the material can include harvesting and culturing chondrocytes from the patient.

Abstract: A method for treating or preventing spontaneous preterm birth in pregnant women and improving neonatal morbidity and mortality. The method includes administering to a pregnant woman in need thereof an effective amount of progesterone sufficient to prolong gestation by minimizing the shortening or effacing of her cervix. Treatment and prophylaxis with progesterone in pregnant women having symptoms of short cervix has been clinically shown to increase neonatal health.

Abstract: A novel process for bacterial production of nanocellulose hydrogel pouches for applications for cell therapy, cell encapsulation, cell delivery, cell proliferation and cell differentiation has been invented. The process is based on fermentation of bacteria producing nanocellulose in oxygen permeable mold interconnected with tubing with diameter less than 5 mm. The resulting Bacterial Nanocellulose (BNC) hydrogel pouch is biocompatible and non-degradable in the human body. The inner wall of the pouch is highly porous and supports cell migration, cell proliferation and cell differentiation. The wall of the pouch allows controlled diffusion of extracellular components. The BNC pouch with injected cells can be implanted and used for treatment of diseases such as diabetes by local delivery of insulin. There are numerous applications of BNC pouches with injected cells in tissue engineering, regenerative medicine and cancer treatment.

Abstract: The present invention relates to mechanically elongated neurons and provides useful compositions, devices and methods for treating a nerve lesion using such mechanically elongated neurons.

Abstract: The invention relates to compositions, methods, and kits for treating subjects infected by or at risk of infection with a DNA virus (e.g., a JC Virus or a BK virus). Aspects of the invention are useful to prevent or treat DNA virus associated conditions (e.g., PML) in subjects that are immunocompromised. Compositions are provided that inhibit intracellular replication of DNA viruses.

Abstract: Embodiments herein are directed to methods for increasing testosterone levels in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of testosterone by needle-free injection to an injection site. Some embodiments are further directed to a method of increasing testosterone levels in a subject in need thereof, by administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of testosterone and a pharmaceutically acceptable carrier by needle-free injection. Some embodiments are directed to a method of minimizing fluctuations in testosterone levels in a subject diagnosed with hypogonadism, comprising serially administering to the subject a therapeutically effective amount of testosterone by needle-free injection to an injection site.

Abstract: Devices, systems, or methods are disclosed herein for treatment of disease in a vertebrate subject. The device can include a quasi-planar substrate; and one or more laterally-mobile effector molecule types at least partially embedded within the quasi-planar substrate, wherein the one or more laterally-mobile effector molecule types is configured to interact with one or more cell types. The device can further include one or more sensors configured to detect at least one aspect of an interaction between the at least one of the one or more laterally-mobile effector molecule types and the one or more cell types; and a controller in communication with the one or more sensors, wherein the controller is configured to responsively initiate modification of at least one of the one or more laterally-mobile effector molecule types, the quasi-planar substrate, and the one or more cell types.

Abstract: A warm perfusion system that has the ability to support a tissue or organ at a near normal metabolic rate provides the mechanism not only for restored oxidative metabolism of the organ but for the delivery of cells, cell-based therapeutics, and growth and differentiation factors to a damaged tissue or organ. Subsequent to delivery of therapeutic cells, such as stem cells or progenitor cells, to the damaged organ, the cells can be prompted to grow, multiply and differentiate, thereby restoring damaged tissue.

Abstract: Disclosed are methods and devices for restoring or establishing nutrient flow to the nucleus pulposa. An implant comprises a nutrient flow path for extending between a source of nutrients and the nucleus pulposa. The implant is positioned within the patient such that a first end is in nutrient flow communication with a subject nucleus pulposa, and the source end is positioned in nutrient flow communication with a source of nutrients.

Abstract: A method, technique and system is disclosed for the delivery of therapeutic agents and/or into the bulk brain tissues and other parts, tissues and organs of the body, including vasculature. A novel form of coaxial catheter provides a means for implanting an outer tube into the brain, then inserting an inner tube into the outer tube and aligning them such that port holes on both of the tubes will overlap and permit a flux of the therapeutic agent to flow into the brain in such a way as to minimize the effects of trapped air, virtually eliminate backflow of the agent, and avoid the potential for additional damage to the brain since only one surgical placement of the outer tube is needed. Similarly, the method, technique system may be utilized to remove fluids or other medium from the brain, tissues, and organs to minimize the effects of escaped air or negative pressure.

Abstract: The present invention concerns a method of treating an advanced lung disease in a patient in need thereof by lung transplantation.

Abstract: An embodiment of the invention is directed to a bone marrow aspiration device comprising a plurality of syringes, each of which operates in a series of sequential steps to obtain bone marrow of high quality and therapeutic value, i.e., having a high MSC/ml number. An embodiment of the invention preferably comprises three syringes, wherein a first syringe is used to aspirate bone marrow from a subject, a second syringe contains an anticoagulant, and the third syringe contains a mixture of the bone marrow aspirate and the anticoagulant.

Abstract: A method of deriving isolated stem cells including: implanting a matrix in a wound site of a living organism; allowing cells to infiltrate the matrix; removing the matrix containing the infiltrated cells from the wound site; and removing the infiltrated cells from the matrix to provide isolated stem cells. Stem cells produced by this process, stem cells with certain characteristics, and methods for treating wounds using these stem cells are provided.

Abstract: A new and useful method for regenerative repair of wounds implementing photonic wound debridement and stem cell deposition is presented which consists of a Wound Assessment and Debridement, Wound Infrastructure Building, and Cell Deposition phases. The present invention allows structured regenerative repair of the wound, utilizes robotic systems to inspect, define and debride the wound, and prints an extracellular matrix on the prepared wound site which speeds healing using developing stem cell technologies. This device is believed to be useful in hospitals and clinics, wherein patients with wounds related to skin trauma such as burns, infection, or melanoma are present. An example of a theatre of use is a children's burn ward. This device is also believed to be useful in military hospitals which receive soldiers injured in combat.