Abstract: The present invention relates to catheter devices and methods for their use to modulate medical agents at selected locations in a patient's body.

Abstract: An intervertebral disc is treated by providing supplemental nutrition to increase viability and longevity. In the preferred embodiment, the invention uses one or more porous stents that function to irrigate the disc space. The stents provide channels for diffusion of fluids and nutrients from the vertebral endplates. The stents may extend across the vertebral endplates to facilitate the transfer of nutrients and oxygen from the vertebral bodies.

Abstract: A novel process for paving or sealing the interior surface of a tissue lumen by entering the interior of the tissue lumen and applying a polymer to the interior surface of the tissue lumen. This is accomplished using a catheter which delivers the polymer to the tissue lumen and causes it to conform to the interior surface of lumen. The polymer can be delivered to the lumen as a monomer or prepolymer solution, or as an at least partially preformed layer on an expansible member.

Abstract: Methods of modifying polypeptide drugs in order to enhance their transdermal electrotransport flux are provided. The polypeptide is modified by substituting a histidine residue (His) for one or more glutamine (Gln), threonine (Thr) and/or asparagine (Asn) residue(s). The His for Gln substitution is particularly preferred from the standpoint of retaining biological activity of the parent polypeptide. Compositions containing the modified polypeptide, which are useful for transdermal electrotransport delivery, are also provided.

Abstract: Provided herein are methods for inducing bone formation in a mammal sufficient to fill a defect defining a void, wherein osteogenic protein is provided alone or dispersed in a biocompatible non-rigid, amorphous carrier having no defined surfaces. The methods and devices provide injectable formulations for filling critical size defects, as well as for accelerating the rate and enhancing the quality of bone formation in non-critical size defects.

Abstract: This invention provides various combinations of enzyme replacement therapy, gene therapy, and small molecule therapy for the treatment of lysosomal storage diseases.

Abstract: Polypeptides selected from the group of growth factors and cytokines are administered by intrapulmonary inhalation. Disclosed are novel compositions and devices for effecting the intrapulmonary administration of these polypeptides.

Abstract: The present invention provides methods and devices for the delivery of gene therapy pharmaceuticals to a mammalian organ in situ, in vivo, ex vivo, or in vitro. In particular, the methods and devices relate to contacting a mammalian organ viral vector with a gene therapy pharmaceutical in a re-circulating, oxygenated perfusate solution for a sufficient time to provide an effective delivery of the gene therapy pharmaceutical to the target tissue.

Abstract: Methods, systems, and devices for promoting ultrasound-mediated gene transfection in vivo are disclosed. The methods and devices of the invention administer a gene formulation to the subject; and apply ultrasound energy to the subject, such that cell transfection is promoted. The ultrasound energy can be provided by an external source or an ultrasound source disposed inside the subject's body. For example, the source of ultrasound energy can be disposed on a catheter. The compositions suitable for ultrasound-mediated transfection can include genes (and plasmids containing such genes) in a pharmaceutically acceptable carrier and/or liposomes suitable for injection into a target site, as well as implantable degradable matrix carriers.

Abstract: Provided are methods and compositions for detecting and treating normal, hypoplastic, ectopic or remnant tissue, organ or cells in a mammal. The method comprises parenterally injecting a mammalian subject, at a locus and by a route providing access to said tissue or organ, with an composition comprising antibody/fragment which specifically binds to targeted organ, tissue or cell. The antibody/fragment may be administered alone, or labeled or conjugated with an imaging, therapeutic, cytoprotective or activating agent.

Abstract: A method of preparing a solid-fibrin web is disclosed. The method includes drawing blood from a patient, separating plasma from the blood, contacting the plasma with a calcium-coagulation activator and concurrently coagulating and centrifuging the plasma to form the solid-fibrin web. The solid-fibrin web is suitable for regenerating body tissue in a living organism.

Abstract: A method of making an intradermal injection using a drug delivery device containing the substance to be injected. A device for practicing the method includes a needle cannula having a forward tip and a limiter portion having a skin engaging surface surrounding the needle cannula. The needle cannula is in fluid communication with the substance and the tip of the needle cannula extends beyond the skin engaging surface a distance equal to approximately 0.5 mm to 3.0 mm. The needle cannula includes a fixed angle of orientation relative to the plane of the skin engaging surface. The skin engaging surface limits penetration of the needle tip into the skin so that the substance can be expelled through the needle tip into the dermis layer. Preferably, the fixed angle of orientation of the needle cannula is generally perpendicular relative to the skin surface, and the skin engaging surface is generally flat.

Abstract: The present invention provides prophylactic and therapeutic methods of treating the ductal epithelium of an exocrine gland, in particular a mammary gland, for disease, in particular cancer. The methods comprise contacting the ductal epithelium of the exocrine gland with an epithelium-destroying gent, preferably by ductal cannulation, so as to realize a prophylactic or therapeutic effect.

Abstract: This invention provides the use of Botulinum toxin (BTX) to cause paralysis of a depressor anguli oris (DAO) musculature in a patient to alleviate downturn at corners of the patient's mouth.

Abstract: The present invention discloses techniques for treating movement disorders by electrical stimulation and/or drug infusion. The present invention utilizes an implantable signal generator and an electrode and/or an implantable pump and catheter. High electrical stimulation pulses and/or drug therapy is provided to the Pedunculopontine Nucleus (PPN). A sensor may be used to detect various symptoms of the movement disorders. A microprocessor algorithm may then analyze the output from the sensor to regulate the stimulation and/or drug therapy delivered to the PPN.

Abstract: Disclosed herein are methods for inducing an immunological CTL response to an antigen by sustained, regular delivery of the antigen to a mammal so that the antigen reaches the lymphatic system. Antigen is delivered at a level sufficient to induce an immunologic CTL response in a mammal and the level of the antigen in the mammal's lymphatic system is maintained over time sufficient to maintain the immunologic CTL response. Also disclosed is an article of manufacture for delivering an antigen that induces a CTL response in an animal.

Abstract: A process for treating inflammation in a joint whether heat, redness, pain, swelling and/or stiffness, and for increasing motion and increasing joint space and correcting mal-alignment, comprising the steps of dissolving a quantity of growth hormone (somatotropin), preferably in purified form, in a buffer solution, and injecting one time or multiple repeat times, a single dosage of the mixture of purified growth hormone and buffer solution into the joint of a body so as to initiate the treatment process. The present invention is also directed to a process of preparing a joint for treatment of inflammation, as described herein, by injecting or otherwise applying one or more of a group of agents, such as an anti-growth factor, an anti-cytokine or an anti-kinase (or a combination thereof) to quiet and reduce deleterious activity in the joint.

Abstract: Provided are methods and compositions for detecting and treating normal, hypoplastic, ectopic or remnant tissue, organ or cells in a mammal. The method comprises parenterally injecting a mammalian subject, at a locus and by a route providing access to above-mentioned tissue or organ, with an composition comprising antibody/fragment which specifically binds to targeted organ, tissue or cell. The antibody/fragment may be administered alone, or labeled or conjugated with an imaging, therapeutic, cytoprotective or activating agent.

Abstract: A process has been developed to reduce or relieve prostatic obstruction. The steps involved in the TUVOR Process include: 1. Transurethral Incision; 2. De-bulking and Intra-Prostatic Volume Reduction; 3. Intra-prostatic void exclusion and space filling with adhesive and/or therapeutic polymeric materials, alone or in combination with bioactive agents and/or mechanical means for closure; 4. Endourethral compression and prostatic mass remolding; 5. Endourethral Polymer Liner Layer. This liner formed from structurally supportive, yet eventually biodegradable, polymers further bolsters and supports the urethra and peri-urethral tissue during healing, eliminating the need for post-procedure catheter drainage. This step may be optional in specific clinical circumstances. The process is designed to allow outpatient treatment under local anesthesia for BPH.

Abstract: A method of treating an acute myocardial infarction (AMI) using human growth hormone to prevent most of the complications and the destructive process of cells and collagen framework which are linked to the AMI. This treatment can be used alone or in combination with other well-known methods of treatment.

Abstract: The present invention is based on the development of a method for cosmetic delivery of L-ascorbic acid-containing compositions to the layer of the skin wherein collagen formation takes place to enhance production of collagen and thereby combat some of the effects of aging and oxy-radical damage on skin. Sufficient electric pulses applied to a region of skin surface temporarily create new pathways through the lipid skin barrier, thereby delivering an L-ascorbic acid-containing composition through the lipid skin barrier and enhancing production of collagen in the region of the skin so treated. A handheld electrical pulser apparatus, optionally table-top adaptable, and methods of use for cosmetic treatment of degenerative skin conditions are provided by the invention.

Abstract: A ball-shaped implant made out of a pliable fiber. The fiber is introduced into the body and when it encounters body tissue it folds upon itself to form a ball-shaped implant. A fluid may be placed around the implant either to hold it in place or to add a biologically active agent to the implant. The fiber of the implant may be biodegradable, or hollow and porous to allow for drugs placed inside the fiber to be administered to the body. One end of the fiber may be long enough to extend out of the body for later removal.

Abstract: In the method proposed, the implant material in the form of a fibre is unwound from a bobbin (10) with the aid of a stream of air (24) and injected through a tube (19) into the body (22). In front of the distal opening (20) of the fibre injection tube, the implant material forms a coherent, open-pore structure in the form of a ball of fibre (25). The fibre-injection tube (19) can be a syringe needle, a catheter or an endoscope tube. This enables the implant (25) to be inserted using minimum-invasive surgery. The size and shape of the implant thus produced can be very variable and can be determined intra-operatively. Various implant materials and fibre shapes can be used. Possible applications of the implant are in the filling of body cavities, systems for the controlled release of systemically acting drugs or chemotherapeutic agents, the induction of tissue, cell transplantation and therapeutic embolization.

Abstract: Provided herein are methods for inducing bone formation in a mammal sufficient to fill a defect defining a void, wherein osteogenic protein is provided alone or dispersed in a biocompatible non-rigid, amorphous carrier having no defined surfaces. The methods and devices provide injectable formulations for filling critical size defects, as well as for accelerating the rate and enhancing the quality of bone formation in non-critical size defects.

Abstract: A method for delaying the onset, retarding the progression, and causing regression of atherosclerosis in a mammal comprises: (a) treating an aliquot of mammalian blood ex vivo with at least one stressor selected from the group consisting of a temperature above or below body temperature, ultraviolet light and an oxidative environment; and (b) administering the aliquot of blood treated in step (a) to the mammal, wherein the aliquot has a volume sufficient to achieve a reduction in lipid levels in the mammal.

Abstract: Implantable therapy systems are disclosed for the local and controlled delivery of a biologically active factor to the brain, spinal cord and other target regions of a subject suffering from a dibilatating condition. The method of the invention involves surgically exposing an insertion site, generally located above a predetermined treatment site (12), in a patient. A cannula (20), having an obturator (30) or dilator (104) positioned therein, is inserted at the insertion site, defining a pathway to the treatment site. In some instances, the cannula can be inserted along the path of a guidewire (102) previously positioned at the treatment site. The cannula (20) is preferably a low friction polymeric material such as polytetrafluoroethylene. The cannula (20) generally has an open proximal end for receiving the obturator (30) or dilator (104), and an open distal end, preferably a tapered end, for delivery of neurologically active factors to the treatment site (12).

Abstract: A method and apparatus for molding polymeric structures in vivo is disclosed. The structures comprise polymers that may be heated to their molding temperature by absorption of visible or near-visible wavelengths of light. By providing a light source that produces radiation of the wavelength absorbed by the polymeric material, the material may be selectively heated and shaped in vivo without a corresponding heating of adjacent tissues or fluids to unacceptable levels. The apparatus comprises a catheter having a shaping element positioned near its distal end. An emitter provided with light from at least one optical fiber is positioned within the shaping element. The emitter serves to provide a moldable polymeric article positioned on the shaping element with a substantially uniform light field, thereby allowing the article to be heated and molded at a desired treatment site in a body lumen.

Abstract: The present invention provides a method for treating Hemophilia A or B which comprises implanting in fluid communication with the bloodstream of a mammal in need of such treatment a permeable membrane having one or more walls, a hollow chamber therewithin, a plurality of holes extending through the walls of the membrane and permitting fluid to enter and exit the chamber of the membrane, each of the holes being sized so that it is large enough to permit inactive Factor VII to enter the chamber of the membrane and activated Factor VIIa to exit the chamber of the membrane but small enough to prevent fibrinogen from entering the chamber of the membrane, a plurality of supports being disposed within the chamber, and an effective amount of a Factor VII activator or a source of the activator being bound to the supports, wherein inactive Factor VII in blood passing through the membrane becomes activated into Factor VIIa upon contact with the activator within the chamber.

Abstract: A needleless syringe having a membrane (28) which is ruptured by gas pressure to generate a supersonic gas flow in which particles containing a therapeutic agent are injected.

Abstract: A method and apparatus for introducing a preselected molecule into a living cell by contacting the cell with the preselected molecule and applying a multiple series of electrical pulses to the cell. The method can be utilized ex vivo. The multiple electrical pulses generate rotating electric fields which introduce transient pores in the living cell without killing the cell. The rotating electric fields are provided in a flow through chamber apparatus having more than two electrodes. A three-step pulse process, e.g. collection, electroporation, electrophoresis, is used to introduce the preselected molecule into the cell. A mechanical means of repositioning cells between successive pulses is also provided. The apparatus can also provide a means to pulse cells at different temperatures and then after pulsing, let the cells recover for a specified residence time at another temperature.