Abstract: Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for transversely driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force transverse to the shaft. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.

Abstract: Devices and methods of delivering therapeutic agents to tissue are provided, which provide reduced outflow of therapeutic agents from an injection site. The methods include delivering one or more clot-promoting substances, such as platelets, fibrin and/or thrombin, to the injection site to entrap the therapeutic agent in the injection site. Devices include devices that are suitable for use in the provided methods.

Abstract: A method is disclosed for the delivery of therapeutic agents into tissues, blood vessels, and body ducts of the human body. A novel catheter enables controlled directing of emitted drug delivery to assist control of drug dwell time in targeted areas. One coaxial catheter embodiment provides capability for locating an outer lumen of the system into the target region, with localization of said outer lumen carried out by use of appropriate medical imaging modalities. In one embodiment, an inner lumen of the catheter means is primed with the agent to be delivered, and recirculated flow of the agent through pluralities of appropriately positioned port holes on the two lumens then occurs via one or more active and/or passive flow driving and guiding techniques intrinsic to the design of the coaxial catheter system.

Abstract: Modified red blood cells are described. In an embodiment, the modified red blood cell includes a target-binding agent. Targeted delivery of imaging agents, drugs, and peptide and protein pharmaceuticals using modified red blood cells are described. Processes for preparing the modified red blood cells, pharmaceutical and diagnostic compositions containing the same and methods of diagnosis and treatment involving the modified red blood cells are described.

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: Methods and apparatus for delivery of substances or apparatus to target sites located outside blood vessels within the body of a human or animal patient. A vessel wall penetrating catheter is inserted into the vasculature, positioned and oriented within a blood vessel near the target extravascular site and a penetrator is advanced from the catheter so as to penetrate outwardly through the wall of the blood vessel in the direction of the target site. Thereafter, a delivery catheter is passed through a lumen of the penetrator to the target site. A desired substance or apparatus is then delivered to or obtained from the target site. In some applications, the penetrator may be retracted into the vessel wall penetrating catheter and the vessel wall penetrating catheter may be removed, leaving the delivery catheter in place for chronic or continuous delivery of substance(s) to and/or obtaining of information or samples from the target site.

Abstract: Apparatus and methods are provided for treating an infracted region of myocardium following acute myocardial infarction by reducing the rate of blood flow through infracted region, and then injecting a solution containing stem cells, endothelial progenitor cells or mediators of stem cell mobilization, migration and attachment into the effected region so that the stem cells become embedded therein and promote tissue regeneration. In a first embodiment, delivery of the stem cells, endothelial progenitor cells or mediators of stem cell mobilization, migration and attachment is accomplished using a catheter that relies upon antegrade flow through the coronary artery and a flow control catheter placed in the coronary sinus. In an alternative embodiment, the delivery catheter delivers the stem cells in a retrograde manner through the coronary sinus, and the delivery catheter further comprises an occlusion balloon for controlling outflow through the coronary sinus ostium.

Abstract: Methods for decreasing the size and/or changing the shape of pelvic tissues. Energy, preferably radio frequency or laser energy, may be applied to endopelvic fascia or other subcutaneous tissue transcutaneously, through one or more incisions in skin, or directly to the desired subcutaneous tissue after a strip of mucosa or skin has been removed. Such an application of energy may cause the subcutaneous tissue to shrink, thereby bringing the mucosa or skin edges closer together while minimizing damage to deep nerves and other surrounding tissues. Such manipulation of the layers of the skin may be utilized to decrease the size or change the shape of numerous anatomical structures and may also serve to alleviate the symptoms of urinary incontinence, dyspareunia, or chronic pelvic pain. The method steps of the present invention may further provide for the beneficial pretreatment of a tissue site prior to stem cell implantation.

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: Systems and methods are provided for locally delivering specific prophylactic, regenerative, or therapeutic agents within the body of a patient. Systems and methods can involve direct delivery of prophylactic, regenerative, or therapeutic agents into branch blood vessels or body lumens from a main vessel or lumen, respectively, and in particular into renal arteries extending from an aorta in a patient. Drug infusion techniques encompass specific treatment and prevention regimes for renal diseases including, but not limited to, Acute Kidney Injury, Renal Cell Carcinoma, Polycystic Kidney Disease, and Chronic Kidney Disease.

Abstract: A cellular delivery device comprising a cellular carrier and an insertion device is provided. The cellular carrier includes at least one elongate strand of biocompatible material with a distal end and a proximal end. A stop member is connected to the proximal end of the elongate strand. The insertion device includes a needle attached to a hollow tubular body. The hollow tubular body is sized to receive the cellular carrier such that at least a portion of the elongate strand may be located within the hollow tubular body and the stop member protrudes from the proximal end of the hollow tubular body.

Abstract: A method of delivering cardiac stem cell and treating damaged cardiac tissue is provided. The method involves isolation of subject's cardiac circulation from the subject's systemic circulation and perfusing a solution comprising stem cells into the cardiac circuit.

Abstract: The present invention relates to methods of inhibiting seizure in a subject. In particular, the invention provides methods of increasing brain leptin levels in a subject.

Abstract: Compositions and methods for treating, preventing and diagnosing Torque teno virus (TTV) infection in pigs are disclosed. Also described are methods of identifying compounds for the treatment and prevention of TTV infection, as well as TTV animal models and methods of producing the same.

Abstract: A method of transplanting an injectable chondrocyte is developed for autologous chondrocyte transplantation, comprising mixing matrices including fibrin, hyaluronic acid and collagen, which are the main ingredients of animal cartilage, and injecting the resulting mixture into a damaged cartilage region. One 1 ml syringe is prepared by mixing 1 ml of a chondrocyte culture with white or light-yellow lyophilized powder (fibrinogen). A second 1 ml syringe is prepared by mixing 1 ml of chondrocyte culture with white lyophilized powder (thrombin), adding 0.1 cc of that mixture to the entire contents of two vials containing chondrocyte suspension, and mixing well. The two syringes are then mounted on a syringe stand, and a mixing tip is mounted to their tips. The contents are mixed in the mixing tip while injecting the resulting mixture into a damaged cartilage region of an animal.

Abstract: A transmyocardial revascularization system including a plurality of inserts formed of a material to elicit a healing response in tissue of the myocardium and deployment instruments and associated components for deploying the inserts into the wall of the myocardium. The inserts are arranged to be disposed within respective lumens or channels in the wall of the myocardium. The inserts can take various forms, e.g., be solid members, tubular members, or porous members, and may be resorbable, partially resorbable or non-resorbable. In some embodiments the inserts are arranged to be left in place within the channels in the wall of the myocardium to result in plural lumens which enable blood to flow therethrough and into contiguous capillaries. The deployment instruments are arranged to pierce the tissue of the myocardium from either the endocardium or the epicardium to insert the inserts into the myocardium, depending on the particular deployment instrument used.

Abstract: The invention provides methods for inhibiting cardiomyopathy and for inhibiting cardiac arrhythmia, by administering to an individual in need thereof a cis-epoxyeicosantrienoic acid, an inhibitor of soluble epoxide hydrolase (sEH), or both. In some embodiments, the method comprises administering to the individual a nucleic acid encoding an inhibitor of sEH. Cardiomyopathies treatable by the methods of the invention include cardiac hypertrophy and dilated cardiomyopathy.

Abstract: Methods, compositions, and kits for repairing damaged myocardium and/or myocardial cells including the administration of cytokines, variants of cytokines, cardiac stem cells, or combinations thereof are disclosed and claimed. In addition, methods, compositions, and kits for forming coronary vasculature including the administration of cytokines, variants of cytokines, cardiac stem cells, or combinations thereof are described. In particular, administration of variants of hepatocyte growth factor, such as NK1, 1K1, and HP11, are useful for the repair and/or regeneration of damaged myocardium or formation of coronary vasculature. Methods of activating cardiac stem cells in vitro are also disclosed.

Abstract: Method and instrumentation for repairing tissue of a heart in a patient's body and implantation of biventricular stimulation. Adult stem cells that have the capability to repair tissue of the selected organ are recovered by harvesting from the patient's body from the same site as the implant of the device and in the same procedure simultaneously. The harvested stem cells are then intraluminally applied through the coronary venous circulation. During the time the stem cells are being applied to the targeted tissue downstream, the designated vessel is selectively occluded to increase concentration and pressure of the applied adult stem cells within that vessel. The implantation of a left ventricular stimulating electrode through the coronary sinus is done within the same operative procedure and connected to either a pacemaker capable of biventricular stimulation for resynchronization therapy or biventricular stimulation and additional defibrillation.

Abstract: An infusion system is for infusing a fluid into the body of a patient. The infusion system includes at least one sensor for monitoring blood glucose concentration of the patient and an infusion device for delivering fluid to the patient. The sensor produces at least one sensor signal input. The infusion device uses the at least one sensor signal input and a derivative predicted algorithm to determine future blood glucose levels. The infusion device delivers fluid to the patient when future blood glucose levels are in a patient's target range. The infusion device is capable of suspending and resuming fluid delivery based on future blood glucose levels and a patient's low shutoff threshold. The infusion device suspends fluid delivery when future blood glucose levels falls below the low shutoff threshold. The infusion device resumes fluid delivery when a future blood glucose level is above the low shutoff threshold.

Abstract: Methods of treating neuronal disorders, such as mechanical neuronal traumas and neurodegenerative disorders, with TWEAK or TWEAK-R blocking agents are presented.

Abstract: An apparatus, system, and/or method for the reconstruction of geometry of a body component and analysis of spatial distribution of electrophysiological values. The shape of the body component is reconstructed based on coordinates associated with data points (e.g., electrophysiological values). The data points are interpolated to form a value distribution map. The value distribution map corresponds to the shape of the body component. A report (e.g., textual report, graphical report) is generated based on the data points and/or the value distribution map.

Abstract: A device and method for regenerating adipose tissue has developed comprising: a washing container filled with an sterile solution for washing the adipose tissues; a syringe container holding syringes for washing and separating adipose tissues; injecting the wash solution and mixing the Bio-Gel, respectively; a second syringe container containing Bio-Gel syringes filled with materials to induce adipogenesis; and connector containers holding connectors for injection of the wash solution, and mixing of washed tissues and Bio-Gel. These containers are restrained in the kit by grooves in the bottom of the box. The box top holds needle containers for transplantation needles; and a protocol for fat transplantation, restrained by grooves. The kit minimizes risk of infection in fat transplantations using the patient's own tissues.

Abstract: A composition for implantation into cardiac tissue includes a biological pacemaker that, when implanted, expresses an effective amount of a mutated hyperpolarization-activated and cyclic nucleotide-gated (HCN) isoform to modify Ih when compared with wild-type HCN. Methods for implementing each of the biological pacemakers include implanting each of biological pacemakers into cardiac tissue.

Abstract: In accordance with the present invention, methods are provided for treating a patient through the use of ultraviolet light activated gene therapy. Embodiments of the present invention include methods for the utilization of light activated gene therapy to repair and/or rebuild damaged cartilage by introducing a desired gene into a patient's tissue.

Abstract: A ventricular assist system includes a controller supplying a DC voltage or an AC voltage, and electromagnets adapted to be adhered to an infarct portion of a heart at the time of embedding a pump. After embedding the system, cells enclosed in capsules are released into the surroundings of the infarct portion by use of a catheter. The capsules are magnetic so that they can be concentrated onto the infarct portion by magnetic fields of the electromagnets, and are broken in the vicinity of the infarct portion, whereby cells effective for regeneration of cardiac muscles can be conveyed to the infarct portion in a noninvasive manner after the embedding of the ventricular assist system.

Abstract: Provided are systems and/or methods that facilitate sensing, detecting, or treatment of a condition or need of a living body using a genetically engineered symbiotic agent.

Abstract: Extracorporeal cell-based therapeutic devices and delivery systems are disclosed which provide a method for therapeutic delivery of biologically active molecules produced by living cells in response to a dynamic physiologic environment. One embodiment includes long hollow fibers in which a layer of cells are grown within the intraluminal volume or within a double hollow-filled chamber. Another embodiment includes a wafer or a series of wafers providing a substrate onto which cells are grown. The wafer(s) are inserted into a device. A device may deliver a pre-selected molecule, for example, a hormone, into a mammal's systemic circulation and/or may deliver a member of different cell products. The device is adapted to secure viable cells which produce and secrete the pre-selected molecule into blood or fluid. The invention also provides a minimally invasive method for percutaneously introducing into a preselected blood vessel or body cavity the device of the invention.

Abstract: The invention relates to methods for the diagnosis, amelioration, and treatment of back pain, particularly lumbar back pain, in particular, back pain caused by muscular abnormalities, vertebral body osteoporosis, and disc degeneration. Patients with back pain are categorized into specific subsets that are deemed to have potential to respond to therapy. In particular, the invention includes a therapy involving stimulation of neovascularization so as to increase perfusion of various spine compartments.

Abstract: An infusion device for continuously infusion of medication is disclosed, in which infusion is controlled over two separate fluid communications. The infusion is in each fluid communication controlled by restricting means and valve means, and one of the fluid communications further contains a holding device for bolus rate of infusion for a short period. The device comprises a flow regulating device comprising a passage defined by at least a fact element is a primary deformable element adapted to be elastically deformed so as to change the cross sectional area of the passage. Furthermore the device comprises a container for storage and supply of a medication in fluid form, said container comprising a first and a second chamber being arranged relatively to each other so that when volume of the first chamber increases the volume of the second chamber decreases.

Abstract: The invention provides a system coupled to a heart having a right atrium (RA) and an atrioventricular (AV) node, which includes an implantable gene regulatory signal delivery device configured to deliver a light to a target site in the heart to transiently control an aberrant cardiac electrical conduction, the light having characteristics suitable for regulating a transcription control element; and an implantable medical device communicatively coupled to the implantable gene regulatory signal delivery device, the implantable medical device including: an atrial fibrillation (AF) detector configured to detect AF; and a control circuit configured to initiate an emission of the light from the implantable gene regulatory signal delivery device in response to the detection of AF. Also provided are methods to transiently control aberrant AV conduction or transiently control cardiac arrhythmias, which employ expression cassettes.

Abstract: The system is composed of two inseparable parts that both make up one Device: I) A container for collecting staminal cells and for their growth factors which is the same as the portcat system with sylicon button to enable the entrance of the Huber needle through a hole. 2) “Active fixation” catheter/s, hollow inside, to permit a rapid flow of the staminal cells into the myocardiac muscular mass and also a rapid flow of the growth factors involved: the various catheters can be fixed to the myocardio by means of an appendix somewhat like a “mouse tail”; they resemble the atrial active fixation catheters that used to be used before the introduction of the J type catheters. The only “but substantial” difference with those mentioned before, is the internal cavity, which should involve even the terminal anchorage part in order to allow the free flowing of any biological material inside the heart without the need for a surgical intervention to open the thorax.

Abstract: The present invention relates to novel method for treating chronic severe heart failure by using insulin-like growth factor-1 (IGF-1). More specifically, the present invention relates to method for improving cardiovascular function and symptoms in a patient with chronic severe heart failure by administering IGF-1 to the patient for a certain period, wherein no options for treating the disorder the patient remain other than heart transplantation.

Abstract: The present invention provides a medicament comprising a gene encoding an angiogenic cytokine for the treatment of acute myocardial infarction (AMI), idiopathic cardiomyopathy (ICM), dilated cardiomyopathy (DCM) or heart failure, to be given in combination with ventricular assist device (VAD).

Abstract: This invention describes a novel method and a novel device for In-Situ replacement of abnormal biomaterials with regenerated new biomaterials having preserved its original functionalities. For example, a scalp tissue with lost hair cells is replaced with a new regenerated scalp tissue having hair cells. The device comprising of an intrusive means to remove or destroy abnormal biomaterials from a body of an individual and a regenerative means to stimulate function-recognitive biomaterials in the body in places where was removed abnormal biomaterials, and then use the stimulated function-recognitive biomaterials to enable or to accelerate regeneration processes of new normally functional biomaterials. The described In-Situ biomaterial regeneration is performed without need of the use of the function-recognitive biomaterials harvested from other places in the body than from the places where were removed abnormal biomaterials.

Abstract: A protein is provided, including a glucose binding site, cyan fluorescent protein (CFP), and yellow fluorescent protein (YFP). The protein is configured such that binding of glucose to the glucose binding site causes a reduction in a distance between the CFP and the YFP. Substance monitoring apparatus (210) is also provided, including a semi-permeable barrier (212), adapted to be implanted in a body of a subject and to allow passage therethrough of a substance, while inhibiting passage therethrough of immune cells; and microorganisms (214), disposed within the semi-permeable barrier (212) so as to produce a measurable response to a level of the substance. A sensor (220) is adapted to measure the measurable response and not to measure a response of any mammalian cells that may be disposed within the semi-permeable barrier (212).

Abstract: A one-step real-time system for treating, reconstructing or augmenting a breast tissue defect in a patient comprising means for extracting adipose tissue, isolate adipocytes, process and re-inject stem and regenerative cells to the breast of the patient.

Abstract: A scleral lens is provided with a drug that is retained in the reservoir of fluid between the scleral lens and the cornea. This system can be used to deliver drugs not currently used because of poor bioavailability, to increase bioavailability of drugs used in patients already wearing a scleral lens, and to improve bioavailability in patients who are not currently wearing the lens. Dosing can be provided less frequently, thus decreasing the risk of non-compliance.

Abstract: A single-use system for separating blood and producing platelet concentrates includes an elongated container for receiving blood from a patient. The container has a movable plunger mounted within the blood container for expressing blood fractions separated during centrifugation of the container through a first port mounted at one end of said container, a second port mounted on the plunger, and a third port mounted on a plunger rod attached to the plunger.

Abstract: A method for repairing tissue of a selected organ from among heart, brain, liver, pancreas, kidney, glands, and muscles in a patient's body. Adult stem cells that have the capability to repair tissue of the selected organ are recovered by harvesting from the patient's body. The harvested stem cells are then intraluminally applied through a designated natural body vessel. During the time the stem cells are being applied to the targeted tissue downstream, the designated vessel or duct is selectively occluded to increase concentration and pressure of the applied adult stem cells by the vessel.

Abstract: Structurally supportive material is implanted or injected into cardiac veins as discrete masses at various sites in the cardiac venous system to reinforce the myocardium for the purpose of preventing, moderating, stopping or reversing negative cardiac remodeling due to various adverse cardiac conditions, both acute and chronic, or for the purpose of treating localize anomalies of the heart, or for both purposes. The sites may be arranged in a pattern about one or more chambers of the heart such that the masses cooperatively reduce stress in the chamber wall and reduce chamber size. Some patterns also cause a beneficial global reshaping of the chamber. These changes occur quickly and are sustainable, and have a rapid and sustainable therapeutic effect on cardiac function.

Abstract: The present invention relates to methods of preventing or treating anal incontinence comprising injecting muscle-derived cells into a site of interest via an injection device, where the injection site of interest is, or is adjacent to, muscle-tissue providing for anal continence.

Abstract: Methods, devices, kits and compositions to treat a myocardial infarction. In one embodiment, the method includes the prevention of remodeling of the infarct zone of the ventricle. In other embodiments, the method includes the introduction of structural reinforcing agents such as those agents containing aloe-derived pectin. In other embodiments, the structural reinforcing agent may be accompanied by other therapeutic agents. These agents may include, but are not, limited to pro-fibroblastic and angiogenic agents.

Abstract: The invention relates to a method of engrafting donor cells into injured myocardium. The method includes delivering donor cells to a delivery site adjacent to and downstream of a chronic total occlusion and treating the chronic total occlusion. The delivery device may be a catheter with a wireguide that may be provided by a retrograde approach via an un-occluded artery or antegrade approach through the chronic total occlusion. The invention also relates to a method of treating injured myocardium and cell compositions for treatment of injured myocardium.

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: The present invention related to methods for treating neurological-urological conditions. This is accomplished by administration of at least one neurotoxin.

Abstract: The present invention provides materials and methods for repairing tissue and using vascular endothelial growth factor C (VEGF-C) genes and/or proteins. Methods and materials related to the use of VEGF-C for the reduction of edema and improvement of skin perfusion is provided. Also provided is are materials and methods for using VEGF-C before, during, and after reconstructive surgery.

Abstract: Methods for delivering first and second fluid compositions to a target location of a subject include delivering the first composition from reservoir of an implantable infusion pump and delivering the second composition through a catheter access port of the implantable infusion device. The access port and reservoir are fluidly coupled to a catheter having a delivery region implanted in the target region. The methods more fully realize the therapeutic potential of infusion devices having both an access port and a reservoir. Strategic use of different agents that compliment the function of each other delivered via either the access port or the reservoir can result in enhanced therapeutic potential.

Abstract: Apparatuses and methods for the effective implantation of viable cells into the body of a patient. Apparatuses and methods are disclosed that are particularly useful for the effective implantation of viable cells into a patient. The apparatuses preferably include a syringe with a small or zero dead volume, a cannula adapted for cell implantation, and a rotational chamber. The syringe is able to hold a cellular suspension for administration to a patient. The apparatuses and methods also preferably employ a small motor which is adapted to rotate the syringe, cannula, and rotational chamber slowly. That rotation reduces cell clumping in the cellular suspension and better maintains the cellular suspension during the implantation procedure. The apparatuses and methods are particularly well suited for the implantation of neurons into the brain of a patient. The apparatuses and methods may also be used to control the rate and volume of cell delivery during implantation precisely and in an automated manner.

Abstract: Disclosed is an implantable material comprising a biocompatible matrix and cells which, when provided to a vascular access structure, can promote functionality generally. For example, implantable material of the present invention can enhance maturation of an arteriovenous native fistula as well as prolong the fistula in a mature, functional state suitable for dialysis. Additionally, the present invention can promote formation of a functional arteriovenous graft suitable for dialysis as well as promote formation of a functional peripheral bypass graft. Implantable material can be configured as a flexible planar form or a flowable composition with shape retaining properties suitable for implantation at, adjacent or in the vicinity of an anastomoses or arteriovenous graft. According to the methods disclosed herein, the implantable material is provided to an exterior surface of a blood vessel. Certain embodiments of the flexible planar form define a slot.