Abstract: An access port for subcutaneous implantation is disclosed. Such an access port may comprise a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. Further, the access port may include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. Further, the subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is engraved or otherwise defined by the access port, so as to be visible after implantation via x-ray imaging technology.

Abstract: The subcutaneously implantable vascular access port has two parts including a body and a wing. The body supports a chamber covered by a septum, with a septum held in place over the chamber by a collar. The chamber is coupleable to a vascular structure, such as through tubing extending from the body, for delivery of medical preparations. The body is preferably elongate in form. The wing is configured to be adjustable in width. In one embodiment the wing rotates relative to the body and has an elongate form similar to that of the body. When the wing is rotated it extends laterally from the body and enhances a stability of the body. In another embodiment, the wing is provided as a deformable wing which can expand laterally out of side openings of a cavern in the body into which the deformable wing is inserted.

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: An implantable pump (10) is provided for pumping a drug in a patient's body (100). The pump includes a drug delivery chamber (22) configured to be filled with the drug and a drug delivery catheter (50) having a catheter lumen (58) and a distal end (56), the drug delivery catheter in fluid communication with the drug delivery chamber and configured to deliver the drug to a delivery site (102). It also includes a pushing element (44) coupled to the distal end of the catheter, and configured to push away from the catheter lumen fibrotic matter that has developed in response to the drug delivery catheter. Other embodiments are also described.

Abstract: Implantable drug delivery systems target delivery of small volumes of drugs to specific tissues. In some cases, a drug delivery system includes an implantable osmotic pump connected to a drug-containing housing, with that housing connected to a needle, cochlear implant or other type of component for ultimate delivery to the target tissue. In some implementations, a subcutaneous port receives a fluid from an external pump. The port is connected to a needle or other component for delivery of one or more drugs to the target tissue. Both solid and liquid drug formulations can be used. In embodiments using solid drugs, a separate drug vehicle (such as saline) can be used to dissolve a portion of the solid drug, with the drug-loaded vehicle then delivered to the target tissue.

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: An access portal is provided including a housing, a body defining a fluid reservoir, and a septum enclosing the fluid reservoir. A stem in fluid communication with the fluid reservoir extends from the fluid reservoir. The access portal also includes a reservoir insert disposed within the fluid reservoir, in which the reservoir insert decreases the fluid fill volume of the reservoir.

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.

Abstract: An implantable port with an integral attachment mechanism. The implantable port includes one or more suture needles enclosed within a port body, the suture needle(s) coupled to a movable member such that movement of the movable member results in movement of the suture needle(s) out of the port body and into the tissue of a body into which it is implanted. The movable member can be a cam or tensioning member that rotates about a central port axis. The movable member can be coupled to a gear to permit movement of the movable member following implantation of the port within a subcutaneous pocket.

Abstract: Devices, systems, and methods provide accurate and consistent identification of the center of a magnetic infusion port.

Abstract: An access port for providing subcutaneous access to a patient, and a method of identifying a subcutaneously implanted access port. The access port includes a body capturing a septum that covers a cavity defined by the body, and a pattern of protrusions extending from an outer surface of the septum away from the cavity, the pattern of protrusions detectable through palpation to indentify the access port as a power-injectable port.

Abstract: A venous access port assembly having a housing base with a discharge port, a septum and a cap. An interior reservoir is defined by a well in the housing base and a bottom of the septum, and a passageway extends from the reservoir through the discharge port. The housing base includes a base flange having integrally molded therein indicia identifying an attribute of the assembly. The indicia could be formed of base flange material, or could be formed by voids in the base flange material. If of plastic material, the molded indicia could be applied with a radiopaque agent, thereby allowing the indicia (“CT”) to appear on an X-ray of the patient in a manner informing a practitioner of a particular attribute of the assembly.

Abstract: A multiple septum vascular access port is provided, including a housing, an inner and outer wall, two reservoirs, two septa, and two fluid lines in fluid communication with the two reservoirs. The reservoirs and septa are arranged so that one reservoir and septum is nested within the other reservoir and septum.

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: Systems and methods for orienting a medical instrument relative to at least a portion of a medical device include a first tilt detector associated with the medical instrument and a second tilt detector associated with the medical device. The first tilt detector may be within an orientation device that is coupled to or separate from the medical instrument. The tilt detectors generate signals that may be used to determine the relative orientation between at least a portion of the medical device and medical instrument. For example, in some embodiments, the signals may be used to determine whether the orientations of the portion of the medical device and the medical instrument substantially match.

Abstract: Disclosed is an infusion port for regulating the inflow of an aqueous solution of an aqueous-solution pack into an external wringer spike as at least part of the wringer spike is inserted or withdrawn. The infusion port comprises an inflow part, a securing part, and a cover part. The inflow part is formed with at least one first inflow hole into which the wringer spike is inserted, so as to allow the inflow of the aqueous solution of the aqueous-solution pack as the wringer spike is inserted. The securing part is formed so as to surround at least part of the inflow part and is formed with a movement hole at one end such that the first inflow hole of the inflow part moves to the outside and the inside as the wringer spike is inserted or withdrawn, and secures the inflow part when the first inflow hole moves to the outside.

Abstract: Various methods and devices are provided for reorienting an implantable port. In one embodiment, an implantable port is provided and includes a base adapted to be anchored to tissue, and a housing pivotally mounted on the base and having a septum formed therein and adapted to receive fluid and to provide access to a fluid reservoir formed within the housing. In an exemplary embodiment, the housing can be pivotally mounted to the base using a ball and socket joint. For example, at least one of a distal surface of the housing and a proximal surface of the base is convex, and the other one of the distal surface of the housing and the proximal surface of the base is concave.

Abstract: An access portal is provided including a housing, a body defining a fluid reservoir, and a septum enclosing the fluid reservoir. A stem in fluid communication with the fluid reservoir extends from the fluid reservoir. The access portal also includes a reservoir insert disposed within the fluid reservoir, in which the reservoir insert decreases the fluid fill volume of the reservoir.

Abstract: The present invention is directed to a device for a portable convection enhanced delivery system that allows administering liquids to specific locations within the body, especially tissues and tumors also allowing outsubject treatment. The application system comprises a portable extracorporal pump with a fluid reservoir that is connected via an infusion system to an infusion catheter placeable to any tissue or tumor the fluid should be administered to by high flow microperfusion. The system enables administration of fluids of any kind by convection enhanced delivery also in out-patient treatment. The system can be used for delivering various drugs, proteins, protein toxins, antibodies for treatment or imaging, proteins in enzyme replacement therapy, growth factors and viruses or oligonucleotides in gene therapy etc. The application methods as well as the surgical method to implant this device are enclosed to this invention.

Abstract: A vascular access port and catheter for use in association with same. The port has a length greater than its height and an access face that is angled with respect to the longitudinal axis of the port. The catheter has a first end for association with a port, and a second end with an angled intra-vascular flange. Apart from the flange is an extra-vascular retaining ring. The wall of the vessel is disposed between the intra vascular flange and extra vascular retaining ring to hold the catheter in place without the need of sutures.

Abstract: A needle guard assembly includes a first composite guard and a second composite guard, each including an arrangement of puncture resistant members on a flexible substrate. The first composite guard and the second composite guard are positioned such that the arrangement of puncture resistant members of the second composite guard are misaligned with the arrangement of puncture resistant members of the first composite guard. The assembly further includes an intermediate layer disposed between and connecting the first composite guard with the second composite guard.

Abstract: The invention relates to an implantable drug reservoir (10) having a cavity (28) enclosed by a sheathing (12) and arranged between a proximal end (14) and a distal end (16) for storing one or more drugs (50), having an outlet opening (24) for the drug(s) (50). The drug(s) (50) can be delivered to a delivery region (70) through a puncture device (20) at one end (16). The invention also relates to a device (100) having a drug reservoir (10).

Abstract: A capsule configured for in vivo refilling of a thereapeutic agent. In certain embodiments, the capsule may contain methotrexate.

Abstract: The port includes an elastomeric hollow port body having a first end and a second end, a first port end portion sealingly attached to the first end of the port body and a second port end portion attached to the second end of the port body. The second port end portion includes an outlet for fluid communication with a fluid delivery tube. The elastomeric hollow port body also includes an inner surface and an outer surface, the inner surface forming a lumen for receiving fluid.

Abstract: The invention relates to sterile medical injection catheter ports utilizing a new antimicrobial polymer mixture filled injection port barrier cover. This barrier cover, when screwed onto the injection port, protects the injection port from the colonization of microbes from the inadvertent contamination of the port with contaminated surfaces, including skin and other potential contaminants.

Abstract: A subcutaneous implantable port is provided which includes a housing, a septum, a bottom plate and a catheter connection part. The housing has a structure in which a cup-shaped base having a bottom which includes a recess is covered by a cover. The septum which can be penetrated by an injection needle is disposed inside the housing. The bottom plate is made of a harder material than the base and is disposed on the bottom part inner surface of the base. The recess has an opening of enlarged diameter. The bottom plate has a plurality of corner parts on the outer peripheral edge thereof. The plurality of corner parts bite into the inside surface of the recess as the bottom plate is press-fitted into the recess along the recess depth direction. The bottom plate is fixed to the bottom part of the base.

Abstract: A drug delivery system for an implantable medical device and methods for making and using the same. Embodiments include a housing of an implantable component of the medical device and one or more at least quasi-solid drug-delivery modules that retain an at least quasi-solid state if not a solid state. The drug-delivery modules and component housing are physically distinct, and as such, may be manufactured independently of each other. The independently-manufacturable drug delivery modules each carry a drug, while the component housing has an exterior surface with one or more recesses formed therein. Associated module(s) and recess(es) are correspondingly dimensioned so that each module may be securely retained within an associated recess via, for example, an interference fit such as by physical interlocking or by friction fit. When so retained in a housing recess, the drug-delivery module and surrounding exterior surface of the housing form a contiguous component surface.

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: Methods and devices are provided for adjusting the height of devices in a gastric restriction system. In general, the methods and devices allow one or more implantable housings coupled to an implantable restriction device to have an adjustable height. The housing can include, for example, a fill port housing, a sensor housing, and any other type of housing that can be used in an implantable restriction system and desired to have an adjustable height. The housing can lower in profile over time, e.g., as the patient loses weight, thereby maintaining the housing in a generally predictable location where it can be found and accessed.

Abstract: A drug pump including a housing, reservoir, access port, flow restrictor mechanism, and refill port. The housing defines a discharge outlet, and maintains the reservoir in fluid communication with the refill port. The access port is fluidly connected to the discharge outlet. The flow restrictor mechanism is fluidly connected between the discharge outlet and the access port, positioned to establish outflow and inflow directions. The flow restrictor mechanism has flow restriction characteristics in the outflow direction that differ from flow restriction characteristics in the inflow direction. The flow restrictor mechanism partially restricts fluid flow in the outflow direction such that a clinician can sense a difference between an available injection rate through the access port as compared to through the refill port. Further, the flow restrictor mechanism does not overtly impede fluid withdrawal procedures via the access port.

Abstract: An antimicrobial IV access cap having an inner surface for retaining an antimicrobial agent, and further configured to receive a portion of an access port of an intravascular device.

Abstract: A method and system for cleaning foreign material from a fluid reservoir of an implantable medical device, the fluid reservoir being substantially enclosed in an interior portion of the implantable device and accessible from an environment exterior of the implantable device through a penetrable septum. An elongated member having a first end and a second end is engaged with a source of ultrasonic energy capable of imparting vibrations to the first end. The septum is penetrated by the elongated member in a manner such that the first end extends into the fluid reservoir, and the second end does not extend into the reservoir. The ultrasonic energy source is activated to impart vibrations into the reservoir via the elongated member first end, in an amount sufficient to break up the foreign material into particulates, which can then be removed from the reservoir.

Abstract: An implantable medical device for delivering a therapeutic substance including a housing and a volume sensor assembly. The housing includes a stationary wall and maintains a reservoir containing the therapeutic substance and including a base wall movable relative to the stationary wall such that reservoir volume is a function of a spacing between the base wall and the stationary wall. The volume sensor assembly includes a cap, a shaft, a target, and circuitry. The cap defines a passage extending from an open end, and is mounted to the stationary wall such that the open end is open relative to a stationary wall inner face. The shaft has a first end attached to the base wall and a second end maintaining the target otherwise movably arranged within the passage. The circuitry generates information indicative of a longitudinal position of the target relative to the cap, and thus of the reservoir volume.

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: A single or multi-port vascular access device including one or more reservoirs each covered by a needle-penetrable, self-sealing septum. The one or more reservoirs each open to an outlet in a stem to which the catheter is attached. The reservoir may be generally circular or ellipsoid in shape and large enough so that fluid movement into and out of the needle is unimpeded. In order to maximize flow between the reservoir and catheter and to minimize any regions of impeded or low fluid flow where coagulation or cell shearing may occur, the fluid passage leading from the reservoir through the outlet into the catheter is defined by unique tapered and tangential geometries. For example, the outlet surface may be globally tangent along the entire reservoir surface, or may be globally tangent along only one side of the reservoir surface.

Abstract: A surgical fastening system for implantable devices such as injection port systems. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around it which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.

Abstract: An implantable port for accessing internal body structures, the port comprises a proximal housing including an opening providing access to an interior of the port and a distal housing adapted for assembly with the proximal housing, the distal housing including a reservoir which, when the distal housing is mated with the proximal housing is in fluid communication with the opening of the proximal housing in combination with a radiopaque element in one of the proximal and distal housings, a shape of the radiopaque element identifying, when imaged, a structural characteristic of the port not otherwise identifiable visually.

Abstract: Methods and devices create an intestinal braking effect, are non-invasive or minimally invasive, and may be reversible. These methods and devices are accomplished via stabilized implantable systems and ingestible pills. In one embodiment, a method of producing satiety comprising the steps of accessing a gastrointestinal tract of a patient and implanting an intraintestinal therapeutic substance eluting implant. The implant is capable of eluting a satiety inducing substance selected from at least one of a nutrient, a specific satiety inducing bio-active substance, pancreatic polypeptides, free fatty acids, cholecystokinin, amino acids, glutamine, lipids, linoleic acid, or a combination thereof, from the implant into the gastrointestinal tract.

Abstract: An extractable device is used to insert a medicinal filling into an animal tissue. The device comprises a filling member and a pasty medicine. The filling member is made of a flexible and permeable wall and is provided with a holding portion and an injection port via which the pasty medicine is injected into the holding portion after the filling member is inserted into the animal tissue. The holding portion is provided with an opening which is releasably lashed by one end of one or more threads so as to make the opening leakproof. Upon completion of solidification of the pasty medicine in the holding portion of the filling member, other end of the thread is pulled to unlash the opening of the holding portion, thereby enabling the filling member to be extracted from the animal tissue so as to leave only the medicine in the animal tissue.

Abstract: An extractable device is used to insert a medicinal filling into a spinal disc. The device comprises a filling member and a flowable medicine. The filling member is made of a flexible and permeable wall and is provided with a holding portion and an injection port via which the flowable medicine is injected into the holding portion after the filling member is inserted into the spinal disc. The holding portion is provided with an opening which is releasably lashed by one end of one or more threads so as to make the opening leakproof. Upon completion of solidification of the flowable medicine in the holding portion of the filling member, other end of the thread is pulled to unlash the opening of the holding portion, thereby enabling the filling member to be extracted from the spinal disc so as to leave only the medicine in the spinal disc.

Abstract: A septum for use in sealably covering a fluid cavity of an implantable medical device, such as an access port, is disclosed. The septum is resilient and includes a reinforcement structure that bolsters septum placement over the fluid cavity so as to inhibit unintended separation of the septum from the medical device when the fluid cavity is under pressure, such as during power injection of fluid into the fluid cavity. In one embodiment the septum comprises a resilient septum body that includes a flange disposed about a perimeter thereof. A reinforcement component is disposed in the flange for reinforcing engagement of the flange with a corresponding groove defined about an opening to the fluid cavity of the medical device so as to inhibit unintended detachment of the septum from the medical device. The reinforcement component in one embodiment includes an annular cord disposed in the flange.

Abstract: A guard for protecting an implantable port is provided. The guard includes a cover that is structured to protect a user's implantable port by substantially covering the port without the cover coming into contact with a user's skin above the port. The cover can be a rounded, triangular-shaped cover having peripheral edges that bow outwardly from the center to allow the cover to be placed over circular or triangular-shaped ports. The cover can also be releasably coupled to an adhesive base that is structured to adhere to the user's skin around the port, thus allowing the cover to remain in place on the user's skin. The guard may further include a housing to support the cover, the housing being coupled to the adhesive base prior to the adhesive base being adhered to the user's skin around the port. The cover may then be detachably connected to the housing.

Abstract: A system for identifying an attribute of an implanted medical device, such as an access port is disclosed. In one embodiment, the identification system comprises a marker included with the implanted medical device, wherein the marker relates to an attribute of the implanted medical device. An external detection device is also included, comprising a signal source that emits an incident electromagnetic signal for impingement on the marker of the implanted medical device, a detector that detects a return signal from the marker resulting from impingement of the incident electromagnetic signal, and a user interface for conveying information relating to the attribute based on detection of the return signal. In the case of an implantable access port, for instance, the described system enables information, such as the ability of the port to withstand power injection of fluids therethrough, to be ascertained even after the port has been subcutaneously implanted within the patient.

Abstract: A dual reservoir access port includes a base having proximal and distal fluid reservoirs. The fluid reservoirs each comprise a bottom and a side wall. A dual prong outlet stem projects from a distal end of the base and comprises a first prong and a second prong. A first fluid channel extends through the first prong to the distal reservoir, and a second fluid channel extends through the second prong to the proximal fluid reservoir. A puncture shield is disposed between at least a portion of the second fluid channel and the bottom of the distal fluid reservoir. A needle-penetrable septum is disposed atop of each of the fluid reservoirs. A cap is placed over and around the port base compressing and sealing the septa against the base. A locking collar may be placed over a dual lumen catheter to lock the catheter to the dual prong outlet stem.

Abstract: An apparatus and method are provided for analyzing the release of active agent(s) from pharmaceutical and pharmaceutical-like products. The apparatus and method provide for more accurate simulation of the conditions in the GI tract including forces that are applied to the dosage form.

Abstract: Apparatus is provided which includes a housing, configured for insertion into a body of a subject. The apparatus includes functional cells coupled to the housing and a source of oxygen configured to supply oxygen to the functional cells. The apparatus further includes an oxygen delivery interface configured to receive oxygen from the source of oxygen, and to facilitate passage of the oxygen to the functional cells, while the housing is disposed within the body of the subject. Other embodiments are also described.

Abstract: An attachment mechanism for a surgically implantable medical device includes one or more fasteners which may be simultaneously moved from an undeployed position to a deployed position by operation of an integral actuator. The attachment mechanism may be configured to be deactuated, and the fasteners simultaneously moved from a deployed position to an undeployed position, allowing removal or repositioning of the medical device. An applier includes a locator for detachably holding the implantable medical device, locating it at the desired position, and actuating the attachment mechanism. The applier is configured to undeploy the attachment mechanism the implantable medical device can be detached from the body tissue.

Abstract: A support tool for a supply assembly delivers a functional fluid to an implantable medical device. The supply assembly defines a supply axis. The support tool includes a support member defining an opening. The opening has a support axis, and the opening is configured to receive the supply assembly. The support member includes a three dimensionally contoured nesting surface that conforms to a corresponding three dimensionally contoured surface of the supply assembly. The corresponding surface of the supply assembly nests against the nesting surface to support the supply assembly such that the supply axis remains substantially fixed relative to and aligned with the support axis.

Abstract: A system to generate a navigation field relative to an implanted device is disclosed. The system can include a small and/or thin localizer array positioned in the implanted device. A power management scheme and circuits can be provided to conserve and resource power in the implanted device.

Abstract: A surgical fastening system for implantable devices is disclosed. The implantable device may contain a plurality of fasteners in pre-deployment position, may have a housing fitted over or around it which contains a plurality of fasteners in pre-deployment position, or may be a part of a two-part system into which it fits. Accordingly, the present invention also encompasses a deployment system or tool that optionally positions the implantable device, and which causes the fasteners to move into post-deployment position. The fasteners may be staples, metal loops, coils, springs or hooks formed of biocompatible materials, including shape memory alloys such as NiTi.