Abstract: Non-load-bearing, drug-eluting components, such as a rod cover, that can be added to load bearing spinal implants.

Abstract: A graft includes a flexible, resilient, generally tubular external support and a blood vessel segment, carried within and having an ablumenal surface in contact with and supported by the tubular support, the graft being capable of resilient radial expansion in a manner mimicking the radial compliance properties of an artery.

Abstract: Systems and methods for securing a catheter to an implantable port are disclosed. The system includes a collar having a catheter gripping protrusion and a port lock cavity. A port having an outlet stem with a constant cross-sectional profile is utilized. The collar is configured to mate with a port lock protrusion connected to the port.

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: Devices and methods for transplanting cells in a host body are described. The cell comprises a porous scaffold that allows ingrowth of vascular and connective tissues, a plug or plug system configured for placement within the porous scaffold, and a seal configured to enclose a proximal opening in the porous scaffold. The device may further comprise a cell delivery device for delivering cells into the porous scaffold. The method of cell transplantation comprises a two step process. The device is incubated in the host body to form a vascularized collagen matrix around a plug positioned within the porous scaffold. The plug is then retracted from the porous scaffold, and cells are delivered into the vascularized space created within the porous scaffold.

Abstract: An implantable oxygen generator system is disclosed. The implantable oxygen generator system includes a receiver configured to generate an electrical current, and an electrode set configured to deliver the electrical current to water molecules of an interstitial fluid within a tissue, wherein the electrical current electrolyzes the water molecules into oxygen molecules.

Abstract: An implantable device used in a gastric band system includes an access port, a tube coupled to the access port, and a shielding device covering a portion of the tube. The shielding device is positioned adjacent to the access port and covers the end of the tube coupled to the access port. The shielding device is made from a puncture resistant material, to protect the tube from puncture by a misplaced syringe needle inserted by a physician.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: An implantable access port for use in transferring a fluid transdermally between an external fluid storage or dispensing device and a site within a patient's body is disclosed. The access port includes a base, a bowl-shaped reservoir defined within the base by a smooth surfaced wall, and a septum secured to the base and enclosing the reservoir within the base. The access port also has an outlet passageway defined within the base and extending in communication with a reservoir outlet defined within the reservoir and an external opening defined in the exterior of the base.

Abstract: A vascular access port having a novel septum design that while allowing for larger septum access area and larger degree of access allows for an overall small profile. The present invention further provides for a novel septum and reservoir design that eliminates angular junctions.

Abstract: A method for evaluating dosing from an implanted infusion system that includes receiving input regarding the identity of a therapeutic agent into an external device. The method further includes displaying on the external device a predetermined set of symptoms associated with the therapeutic agent; receiving input into the external device regarding with which of the symptoms the patient presents; and determining whether the therapeutic agent is being delivered, or has been delivered, at an appropriate dose based on the input identity of the therapeutic agent and the input symptoms.

Abstract: An implantable injection port facilitates filling and/or draining an inflatable portion of a gastric band. In an embodiment, the port comprises a movable cap that causes anchor wires to extend from anchor devices in order to implant the injection port in the tissue of a patient. In another embodiment, the port comprises a handle that rotates to implant curved anchors into the tissue of a patient. In yet another embodiment, a cap is configured to move towards a base of the port in order to cause the curved anchors to rotate into the tissue of a patient. The cap may also rotate with respect to the base in order to lock the cap and the anchors in position. Further, surfaces of the injection port may be textured to increase adhesiveness to the patient's tissue during installation and to facilitate simpler installation.

Abstract: The invention concerns a device to inject and/or to take a sample, with the aid of a needle, of a liquid inside the organism of a living being, through the skin in a repeated manner. More particularly, the present invention concerns a device intended to be implanted inside a living, human or animal organism, presenting a vascular system and a skin, to exchange a liquid with the vascular system, through the skin and in a repeated manner, using a needle, the aforementioned device including at least a first tubular puncture site, shaped to be able to be perforated numerous times over all its length, the tubular puncture site being linked up in a watertight manner with a flexible link conduit with the vascular system, the tubular puncture site including an watertight flexible tubing, supported by reinforcement constituted by rigid rings, this being shaped to allow the puncture site to lose its shape to follow the body movements of the patient without causing discomfort.

Abstract: A surgically implantable injection port has a tissue in-growth promoting surface associated with a fluid conduit that is coupled to the injection port. The injection port includes a housing, a fluid reservoir defined in part by the housing, a needle penetrable septum, a fluid conduit in communication with the reservoir, and a tissue in-growth promoting surface coupled to the fluid conduit. The tissue in-growth promoting surface may be provided by surgical mesh wrapped around the conduit or through which the conduit is threaded. The injection port and the fluid conduit may be used as part of a gastric band system or some other type of system.

Abstract: A venous access port assembly having a housing base, a flange, and a septum. The housing base defines an interior reservoir. The flange includes integrally molded X-ray discernable indicia identifying that the assembly is rated for power injection. The X-ray discernable indicia may extend through a height of the flange from a top surface to a bottom surface of the flange. According to one aspect, the flange may be formed from X-ray discernable material, and the X-ray discernable indicia may be formed from the X-ray discernable material of the flange, or they may be formed by voids in the X-ray discernable material. According to another aspect, the flange may be formed from a radiotransparent or radiolucent material and applied with a radiopaque agent, and the X-ray discernable indicia may be one or more voids in the radiopaque agent or may be portions of the flange applied with the radiopaque agent.

Abstract: Devices and methods for obtaining high flow rates in a port catheter system, and devices and methods for using a high flow rate port catheter system are disclosed. In one embodiment, a reservoir is dedicated for aspiration and a separate reservoir is dedicated for infusion. Fluid flow channels associated with aspiration are larger than the fluid flow channels associated with infusion. The catheter connected to the port can have an offset tip configuration. Methods for accessing the port are also disclosed.

Abstract: A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. A plurality of interconnecting channels can extend from the first side to the second side so as to connect a first a plurality of openings on the first side with a second plurality of openings on the second side.

Abstract: Embodiments provide a drug delivery cuff including a drug reservoir. In an embodiment, an integrated drug pump may be provided. A drug delivery cuff in accordance with an embodiment may be placed around any suitable vascular graft (e.g., ePTFE) or directly around any natural tissue conduit (e.g., perivascularly), at any position along the graft/conduit or overlapping a graft and conduit, either at the time of graft surgical placement or separate therefrom.

Abstract: A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. A plurality of interconnecting channels can extend from the first side to the second side so as to connect a first a plurality of openings on the first side with a second plurality of openings on the second side.

Abstract: The invention concerns a flow regulator, made of a stack of 3 plates, respectively a top plate including a flexible membrane (1), a middle plate (2) with pillars and through holes and a bottom plate (3) with fluidic ports, micro channels and through holes (8,9,12). The principle is based on the deformation of the membrane due to the pressure of the liquid. The membrane goes in contact with the pillars of the middle plate, obstructing gradually the through holes of the pillars. The device is designed to keep the flow constant in a predefined range of pressure. The device is dedicated to ultra low flow rate up to 1 ml per day or below, typically for drug infusion. Plastic flow regulators comprise preferably several independent valves coupled in parallel. The membrane plate is therefore made of several flexible membranes obstructing gradually the flow by increasing the pressure. Stress limiters are used to avoid plastic deformation of the membrane.

Abstract: Fluid delivery apparatus is described for the delivery of fluids to regions of the body, especially for delivery to regions of the brain. The apparatus includes a first length of implantable tubing having a first end and a first fluid connector portion attached to the first end of the first length of implantable tubing. The first fluid connector portion is releaseably connectable to a complementary second fluid connector portion. An implantable housing is also provided for enclosing and protecting the first fluid connector portion. The implantable housing is openable to provide access to the first fluid connector portion. For example, the housing may have a hinged lid or cover portion. A corresponding method is also described.

Abstract: One embodiment provides a method for enzymatic treatment, including the steps of forming a closed space on a local tissue area with a device and infusing an enzyme solution into the closed space for enzymatic treatment. The method according to the embodiment is capable of treating the local tissue area with enzymes for enhancing cell proliferation in the treated tissue area and preventing damage of the adjacent normal tissues. A device and kit used for the method are also provided.

Abstract: Implantable infusion devices configured to improve fill and evacuation procedures. Such implantable infusion devices may, for example, include palpable landmarks that allow the clinician to locate a fill port through tactile examination. Needle detection methods are also disclosed.

Abstract: Embodiments of the invention disclose a system for controlled oral drug delivery. The system comprising a removable device comprising a drug to be delivered, wherein the drug is delivered based on osmotic pressure generated in the removable device. Further, the system comprises a receptacle to hold the removable device in an oral cavity, and a base station configured to dock the removable device for determining information about one or more characteristics of the removable device.

Abstract: A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. The length of the channels extending from the first side to the second side may comprise an effective length greater than a distance across the porous structure from the first side to the second side. The therapeutic device may comprise a penetrable barrier to inject therapeutic agent into the device when implanted in the patient.

Abstract: A method and device for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect is provided. The method includes administering a sustained release drug delivery system to a mammalian organism in need of such treatment at an area wherein release of an effective agent is desired and allowing the effective agent to pass through the device in a controlled manner. The device includes an inner core or reservoir including the effective agent, an impermeable tube which encloses portions of the reservoir, and a permeable member at an end of the tube.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: An implantable port includes a body with a reservoir in the body, a tunnel extending from the reservoir to an outer surface of the body, a pivoting coupling connected to the body near the tunnel on the outer surface, and a stem connected to the pivoting coupling.

Abstract: A method is provided for local controlled delivery of a drug to the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of a patient in need of treatment. In one embodiment, the method includes implanting a resorbable drug delivery device within the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens of the patient. The drug delivery device may include an elastic device body housing at least one drug reservoir which contains at least one drug. In a preferred embodiment, the method further includes releasing the drug from the device in a controlled manner to, typically directly to, the seminal vesicle, the prostate, the ejaculatory duct, or the vas deferens.

Abstract: In various embodiments, a drug-delivery device includes one or more reservoirs that may each contain a therapeutic agent for delivery to a patient.

Abstract: A number of parameters related to the operation of a fluid delivery device are determined based on pressures within the device sensed using multiple pressure sensors. In one example, the volume of therapeutic fluid within a reservoir of a fluid delivery device is estimated based on a measured pressure differential. In another example, the rate at which a therapeutic fluid is added to or removed from the reservoir is estimated based on the measured pressure differential.

Abstract: Devices and methods are provided for delivery of a positive inotropic agent to the heart of a patient in need thereof. An epicardial patch includes (i) a backing layer which is impermeable to the positive inotropic agent; and (ii) a drug release layer attached to the backing layer and including the positive inotropic agent and a polymeric membrane material. The polymeric membrane material provides controlled release of the positive inotropic agent to the epicardium to a region of the myocardium and in an amount effective to increase contractility. At least one of the backing layer or the drug release layer includes a tissue coupling portion for affixing the epicardial patch to an area of the epicardial surface. The epicardial patch is dimensioned and compliant to substantially avoid impeding myocardial functionality when affixed to the area of the epicardial surface.

Abstract: The present invention consists of an implantable structural element for in vivo delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Alternatively, the implantable structural element may simply be an implantable article that serves the single function of acting as a time-release carrier for the bioactive agent.

Abstract: The present invention relates to methods for encapsulating pancreatic progenitors in a biocompatible semi-permeable encapsulating device. The present invention also relates to production of human insulin in a mammal in response to glucose stimulation.

Abstract: A fluid flow regulator (1) of the passive type is disclosed which has a fluid inlet adapted to be connected to a fluid reservoir and a fluid outlet (13) adapted to be connected to a patient's body. The regulator comprises a rigid substrate (2) and a resilient membrane (3) tightly linked together so as to define a cavity (6) there between which is disconnected to the fluid outlet while the membrane has a first surface (12) opposite the cavity which is connected to the fluid inlet. The membrane has a plurality of through holes (15) contiguous with the cavity, to define a pathway for a fluid from the fluid inlet to the fluid outlet, and is flexible so as to be able to come into contact with the substrate as a fluid applies a sufficient pressure on the first surface.

Abstract: A needle apparatus for aligning a needle with a port of an implantable infusion device includes a needle anchoring portion configured to axially fix the apparatus relative to a needle to be inserted into the port. The needle apparatus further includes a port locating portion fixable relative to the needle anchoring portion. The port locating portion includes a port location signal receiver module for receiving a signal from an implantable infusion device regarding the location of the port of the infusion device.

Abstract: The invention relates to implantable vascular access ports that can release agents such as antibiotics, anti-thrombogenics and anti-proliferatives. The invention also relates to ports having locking mechanisms that prevent accidental disengagement, and structures that facilitate surgical implantation and provide for long-term stability and use of the port.

Abstract: A system including an implantable delivery device having a housing, a reservoir, fill and catheter access ports, and a denial device. The housing maintains the fill port in fluid communication with the reservoir. The catheter access port includes a septum between an inlet and a well. The denial device includes a pin, a biasing element, and a solenoid. The pin is arranged to be movable between a first position in which the pin blocks passage of a needle into the well and a second position, with the biasing element biasing the pin to the first position. The solenoid is operatively coupled to the pin and provides an energized and de-energized states; in the energized state, the solenoid moves the pin from the first position to the second position to permit access to the well. An external controller effectuating clinician control over operation of the denial device is also provided.

Abstract: An implantable medication delivery device that is highly space efficient and can reliably and safely deliver controlled medication doses to a target site. The system includes a variable volume medication reservoir that is exposed to an ambient pressure equal to the ambient pressure at a system outlet port. A pump/valve subassembly is provided to draw medication from the reservoir and force a medication dose along a fluid transfer passageway to the outlet port. The pump/valve subassembly incorporates a safety mechanism, e.g., a balanced valve, which normally blocks medication flow to the outlet port and opens only in response to a pump induced unbalancing force. A protective shell is also disclosed for protecting the ambient reservoir.

Abstract: A vascular access port is described that is elongate in form. A distal end is coupled to a tube which leads into a body lumen. A proximal end has a head thereon with a septum which can be repeatedly penetrated by a needle and reseal, for repeated administration of medications or other compositions through the port and into the body of the patient. A wing is attached to the body that has two positions including a streamlined first position for implantation and a wider second position for stabilization of the port after implantation. A stay is preferably also provided to abut the wing when in the second position to keep the wing in the second position when fully deployed.

Abstract: An insertion device for inserting an infusion device at least partially into skin for subcutaneous infusion can comprise a sleeve having a lower surface that is configured to engage the skin, a shuttle or carriage to carry the infusion device between a retracted position and an advanced position; at least a first biasing member to urge the shuttle or carriage toward the advanced position, and an actuator to cause the first biasing member to urge the carriage from the retracted position to the advanced position. In some embodiments, the insertion device can further comprise a hub and at least a second biasing member to urge the hub away from the shuttle or carriage. In some embodiments, the insertion device can further comprise a needle attached to the hub. Methods for inserting an infusion device and various other features that can be comprised by an insertion device are also disclosed.

Abstract: The present invention provides an improved vascular access port comprising a port base with a metallic dish insert molded (or bonded) into the bottom of the reservoir. In one embodiment, a single reservoir is provided. In another embodiment, plural reservoirs are provided. The metallic bottom of the reservoir provides a hard surface that will resist abrasion and puncture by the access needles used to infuse medication or withdraw blood. Additionally, the single and dual ports can include exit ports that are intended to better anatomically fit into the subcutaneous areas around muscle tissue.

Abstract: The invention relates to an implantable medical device for injecting and/or collecting fluid substance into and/or from a human or animal organism, said device comprising a casing (6) whose wall (3) delimits a chamber and is pierced with at least a first access orifice (7) designed to allow a needle to pass through said wall (3), said device being characterized in that the first access orifice has a staged structure comprising: a guide portion designed to limit the angular clearance of the needle when said needle is engaged therein, and a flared intake portion that forms a continuation of the guide portion, so as to be able to cause the trajectory of the incoming needle to converge on the guide portion. Implantable medical devices.

Abstract: A system for perfusion management that monitors, maintains, diagnoses, or treats perfusion deficiencies.

Abstract: A system for perfusion management that monitors, maintains, diagnoses, or treats perfusion deficiencies.

Abstract: A system for perfusion management that monitors, maintains, diagnoses, or treats perfusion deficiencies.

Abstract: A tissue thickness compensator may generally comprise a first layer comprising a first medicament, a second layer comprising a second medicament, and a third layer comprising a third medicament. The tissue thickness compensator may comprise a first layer comprising a first medicament, a second layer comprising a second medicament, and a reservoir comprising a third medicament disposed within the reservoir. The medicaments may be independently selected from a haemostatic agent, an anti-inflammatory agent, an antibiotic agent, anti-microbial agent, an anti-adhesion agent, an anti-coagulant agent, a pharmaceutically active agent, a matrix metalloproteinase inhibitor, and combinations thereof. Articles of manufacture comprising the tissue thickness compensator and methods of making and using the tissue thickness compensator are also described.

Abstract: A port for subcutaneous implantation, comprising a housing including first and second wells formed therein and a substantially F-shaped flow element including first and second lumens extending therethrough wherein, when in an operative configuration the F-shaped flow element is coupled to the housing with a proximal end of each of the lumens in fluid communication with a respective one of the first and second wells for receiving fluid therefrom, and wherein distal ends of each of the lumens form outlets, each outlet being coupleable to a lumen of a medical catheter, the F-shaped flow element including first and second arms extending from a trunk with the first lumen extending through the first arm to the trunk and the second lumen extending through the second arm to the trunk, the first and second lumens being separated from one another within the trunk.

Abstract: A port for implantation within a body, comprises a housing having proximal and distal surfaces and a side surface wherein, the proximal surface faces outward toward the skin, the distal surface faces inward away from the skin and the side surface extends between the proximal and distal surfaces. A first well formed within the housing includes a first opening in the proximal surface and a second well formed in the housing adjacent to the first well has a second opening formed in the proximal surface. First and second outlet openings formed on the side surface of the port are in fluid communication with the first and second wells, respectively, and are separated from one another by a distance substantially equal to a distance separating lumens of a dual lumen catheter to which the port is to be connected.

Abstract: The invention relates to a catheter port for supplying an active substance to an active site which is distant from the port. According to the invention, the housing (1) of the port is designed to have two parts, an upper housing part (7) and a lower housing part (6). The upper housing part (7) holds an insertion part (10) in a clamping manner in a housing recess (8) of the lower housing part (6), wherein a chamber (11) is arranged in said insertion part for receiving the active substance with the interpositioning of a punctured membrane (17) that can be pierced with an injection cannula. While the insertion part (10) and the chamber (11) can be manufactured from a material resistant to the active substance, preferably a heavier ceramics, the upper and lower housing parts may consist of a lighter biocompatible plastic material. It is advantageous that the patient only comes into contact with the upper and lower housing parts made of a biocompatible plastic material and not with the insertion part.