Abstract: An infusion system for subcutaneous delivery of a fluid to a subject is disclosed. The infusion system comprises a source of a fluid; a fluid delivery system; a first fluid conduit in fluid communication with the source of the fluid and the fluid delivery system; a fluid injection device configured to be inserted into the skin of a subject for delivering the fluid to the subject; a second fluid conduit in fluid communication with the fluid delivery system and the fluid injection device; and a support frame attached to the source of the fluid and the fluid delivery system, wherein the support frame is configured to mount the source of the fluid and the fluid delivery system on a region of a head of the subject. The fluid delivery system moves the fluid from the source of the fluid, through the first fluid conduit, through the second fluid conduit, and through the fluid injection device.

Abstract: An automatic fluid injection device having an upper body (1) with an injection system (3, 4, 5) controlled by a power supply (7) and that is triggered by a user interface (100); and an insertion mechanism (8, 9) for inserting an injection needle (110); a base body (2) for coming into contact with an injection zone and having a fluid reservoir (6) containing an injection piston (65), and a needle assembly (10) including the injection needle (110). The injection system has an elongated spring metal strip (3) wound on a respective reel (30) before actuation; and a drive mechanism (5) for unwinding the strip (3) against a respective piston (65) so as to perform the injection, and for rewinding the strip (3) on the reel (30) after injection.

Abstract: An external controller assembly for a medical device implanted in a patient includes an external controller and an external driveline assembly. The external controller includes an external controller display viewable by the patient. The external driveline assembly includes an external driveline cable and an external driveline distal connector. The external driveline cable is connected to the external driveline distal connector and the external controller. The external driveline cable accommodates positioning of the external driveline distal connector, by the patient, for simultaneous viewing of the external driveline distal connector and the external controller display by the patient. The external driveline distal connector is adapted to be connected to the distal driveline proximal connector by the patient. The external driveline distal connector is adapted to be disconnected from the distal driveline proximal connector by the patient.

Abstract: An integrated system for injection including an injection device in electronic connection with a communication device is provided. The external communication device may be a handheld electronic device such as a Smartphone or a dedicated reader such as a reader capable of reading information contained on an RFID tag. The injection device includes a needle and a drug delivery portion enclosed within an external housing. Optionally, a plurality of sensors is affixed to the surface of the needle to collect data about the injection and physical characteristics of the patient. The data may be recorded on a data capture module. The electronic chip may be a readable and writable electronic chip such as a non-volatile memory chip. Alternatively, the electronic chip is a passive RFID tag. The injection device may further include a data transmitter for sending information obtained from the data capture module to the external communications device.

Abstract: The present disclosure relates to methods, devices, kits and systems for enhancing the efficacy and longevity of denervation procedures.

Abstract: A method for correcting a spinal deformity is provided. A spinal implant for correcting a spinal deformity includes a multipoint connector that connects to at least one vertebra of a spine at a plurality of locations and a force directing device that applies a force to the vertebra through the multipoint connector. The force directing device may include a rod which extends generally along an axis of the spine and a force directing member which is adjustably coupled to both the rod and the multipoint connector and which applies a corrective force to the at least one vertebra.

Abstract: An injection system includes a reservoir for containing liquid, and a gating plate having a circular array of gating plate apertures. The injection system additionally includes a faceplate positioned adjacent to the gating plate and having a circular array of faceplate orifices. The injection system also has a motor to rotate the gating plate, and a controller to control the motor for rotating the gating plate into an aligned clocking orientation in which the gating plate apertures and the faceplate orifices are aligned to initiate the formation of a cylindrical array of liquid jets, and rotate the gating plate into a non-aligned clocking orientation terminate formation of the liquid jets after a predetermined discrete quantity of the liquid is injected.

Abstract: Systems and methods and devices are provided for arresting or reversing the effects of myocardial remodeling and degeneration after cardiac injury, without the potential drawbacks associated with previously existing systems and methods, by at least partially occluding flow through the superior vena cava over multiple cardiac cycles, and more preferably, by adjusting the interval or degree of occlusion responsive to a sensed level of patient activity. In some embodiments, a controller is provided that actuates a drive mechanism responsive to a sensed level of patient activity to provide at least partial occlusion of the patient's superior vena cava, while a data transfer circuit of the controller provides bi-directional transfer of physiologic data to the patient's smartphone or tablet to permit display and review of such data.

Abstract: Surgical access devices having wound closure features incorporated as part of the device are provided. The devices allow suture to be inserted directly into the device and operated to close an opening through which the device is disposed as or shortly after the device is removed from the surgical site. Further, the wound closure features allow for various orientations of wound closure to be achieved by adjusting an angle at which the suture enters tissue surrounding the opening to be closed. Some of the wound closure features provided for include openings formed in both the housing and cannula of the surgical access device, multiple openings formed in one or both the housing and cannula, locations of the openings being adjustable or otherwise movable, and various flexible seals. Other features, as well as methods of closing an opening through which the surgical access device was disposed, are also provided.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

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.

Abstract: A power-injectable access port includes a housing defining an internal cavity and including a plurality of suture apertures, a needle-penetrable septum captured by the housing enabling needle access to the internal cavity, a stem having a lumen in fluid communication with the internal cavity, the stem configured for coupling to a catheter, and a radiopaque identification feature observable via imaging technology subsequent to subcutaneous implantation of the port, the feature indicating that the port is suitable for power injection.

Abstract: Embodiments of the present disclosure are directed to systems, devices/apparatuses and methods for assessing a residual insulin value for a user/patient. Such embodiments may be implemented by selecting a first value corresponding to a duration of insulin action; selecting a second value corresponding to a lock out time duration, selecting a first time period beginning at a time point T0 minus the first value and ending at the time point T0 minus the second value, selecting one or more boluses delivered during the first time period; for each of the one or more boluses selecting a corresponding residual insulin value estimated at the time point T0, computing the cumulative residual insulin value by summation of the corresponding residual insulin values.

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 computer-implemented method, system, and/or computer program product selectively sends notifications to mobile devices. One or more processors receive a token authorization to provide notifications of mobile device events to a set of mobile devices operated by a user, and then determine that a push notification of a mobile device event is to be issued to one or more mobile devices from the set of mobile devices. The processor(s) receive a status of applications running on each of the set of mobile devices and an extent of user engagement for each of the applications. The processor(s) associate a content with the push notification, and parse and evaluate the content. The processor(s) select a mobile device from the set of mobile devices based on the status of the applications, the extent of user engagement, and the parsed evaluated content, and then transmit the push notification to that mobile device.

Abstract: Systems and methods and devices are provided for arresting or reversing the effects of myocardial remodeling and degeneration after cardiac injury, without the potential drawbacks associated with previously existing systems and methods, by at least partially occluding flow through the superior vena cava over multiple cardiac cycles, and more preferably, by adjusting the interval or degree of occlusion responsive to a sensed level of patient activity. In some embodiments, a controller is provided that actuates a drive mechanism responsive to a sensed level of patient activity to provide at least partial occlusion of the patient's superior vena cava, while a data transfer circuit of the controller provides bi-directional transfer of physiologic data to the patient's smartphone or tablet to permit display and review of such data.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

Abstract: Ports for accessing a vessels within a patient include passageways that can guide needles or other access devices directly into the vessels. The ports can be implanted subcutaneously within a patient. Some ports may be used in the creation and use of vascular access buttonholes.

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: This kit includes an injection device comprising a needle having a free end pricked into a septum of an implantable chamber and an intermediate tubing connected downstream to the needle. The kit includes an upstream conduit having an upstream end connected to a liquid dispensing apparatus and a downstream end removably connected to the intermediate tubing. The pressure loss through the upstream conduit is greater than 25% of the total pressure loss taken between the upstream end of the upstream conduit and the free end of the needle, upon injecting liquid through the upstream conduit and the injection device.

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

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: Apparatus for delivering therapeutic agents to the central nervous system of a subject is described. The apparatus comprises at least one intracranial catheter and a percutaneous access device. The percutaneous access device comprises a body having at least one extracorporeal surface and at least one subcutaneous surface, the body defining at least one port for connection to an implanted intracranial catheter. The port is accessible from the extracorporeal surface of the device, but is provided with a seal such as a rubber bung between the lumen of the port and the extracorporeal surface. The percutaneous access device may have more than two ports and/or a flange. A method of implanting the percutaneous access device is also described.

Abstract: A septum for sealably covering a fluid cavity defined in an implantable device, which may be an access port, and methods for assembling the implantable device. The septum may include a resilient septum body, an annular flange extending radially outward from the septum body, and a reinforcement component disposed in the annular flange for reinforcing engagement with a corresponding annular groove defined in a body of the implantable device. The reinforcement component may inhibit unintended detachment of the septum from the implantable device.

Abstract: An access port for providing subcutaneous access to a patient is disclosed. The access port includes a septum including palpable identification indicia thereon. In particular, the access port in one embodiment includes a body that defines a fluid cavity and a needle-penetrable septum covering the fluid cavity for providing access thereto. The septum defines an outer periphery. One or more palpation features are included on the septum. The palpation features each include a portion that extends in a radial direction beyond the outer periphery of the septum. The palpation features are therefore disposed relatively farther away from each other, simplifying palpation and identification thereof after the port has been subcutaneously implanted into a patient. The palpation features can be indicative of an attribute of the port, such as its ability to withstand fluid pressures and flow rates associated with power injection, for instance.

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: Systems for detecting needle insertion into a port chamber of an implantable medical device include a pressure sensor. The system detects characteristic pressure profiles associated with needle insertion into the port chamber through a septum and may generate a sensory cue to a clinician that proper needle placement has been achieved. Methods for detecting needle insertion into a port chamber of an implantable medical device includes detecting characteristic pressure profiles associated with needle insertion into the port chamber through a septum.

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 percutaneous fluid delivery device is described that includes a subcutaneous base portion having one or more ports for supplying fluid to one or more implanted catheter devices and a percutaneous portion including an extracorporeal surface. The one or more ports of the subcutaneous base portion are accessible from the extracorporeal surface of the percutaneous portion. The subcutaneous base portion is at least partially insertable into a complementary recess formed in a bone, the subcutaneous base portion including one or more features for gripping the internal surface of such a complementary recess thereby directly anchoring the subcutaneous base portion to the bone. The device may be used to route fluid to neurosurgical catheters optionally via a router unit.

Abstract: The invention pertains to an applicator (1) for inserting an implant, in particular a rod-like implant (2) containing an active substance, under the skin of a human or animal, comprising a housing (3), a cannula (6) extending from the housing (3), and a handle (15) for grasping and maneuvering the applicator (1) and the cannula (6) during insertion of an implant (2). In accordance with the invention, the handle (15) extends above at least part of the length of the cannula (6). Such a handle facilitates insertion of the cannula and/or accurate positioning of the implant.

Abstract: A system for treating heart disease, such as pulmonary hypertension or right heart failure, including an implantable component and external components for monitoring the implantable component is provided. The implantable component may include a compliant member, e.g., balloon, coupled to a reservoir via a conduit. Preferably, the compliant member is adapted to be implanted in a pulmonary artery and the reservoir is adapted to be implanted subcutaneously. The external components may include a clinical controller component, monitoring software configured to run a clinician's computer, a patient monitoring device, and a mobile application configured to run on a patient's mobile device.

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: 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: A injection site information cap includes a housing, a cover portion, an engagement portion configured to couple to and cover an injection port of an injection site, and at least one information element on the cover portion that is positioned to be automatically sensed by at least one sensor of the injection site when the engagement portion is coupled to or is being coupled to the medication injection port. Related apparatus, systems, and techniques are also described.

Abstract: A number of parameters related to the operation of a fluid delivery device are determined based on a pressure within the device sensed using a pressure sensor. In one example, the volume of therapeutic fluid added to or removed from a reservoir of a fluid delivery device is determined based on a sensed pressure of the reservoir. In another example, the volume of therapeutic fluid added to or removed from the reservoir is determined based on a sensed pressure of a refill port assembly of the device. In another example, an initial temperature of the reservoir as a therapeutic fluid is removed from the reservoir is estimated based on a sensed pressure within the device. In another example, a temperature of a therapeutic fluid added to the reservoir is estimated based on a sensed pressure within the device.

Abstract: Patients continue to acquire infections from healthcare facilities such as hospitals at an alarming rate. These infections can be transmitted when drugs or other medical materials are delivered from a syringe system into an IV line through an IV port. Some current methods of preventing contamination include swabbing the syringe with alcohol or using disposable alcohol caps; however, these methods are often inefficient. A system is described using caps that cover the entry and exit points of the IV port and the syringe system, respectively. The caps can be temporarily displaced from the entry and exit points when a sufficient force is applied to an area far enough away from the entry and exit points so as to prevent contamination. Once the caps are displaced, the syringe system can interact with the IV port using a locking mechanism such as luer locks to ensure the stability of the connection.

Abstract: The present invention generally provides a gastric banding system, including an implantable access port. The access port assembly may comprise a self-sealing septum, a housing, a mesh rivet and a mesh layer. The housing may include a septum retaining portion for holding the septum in place, and a base for defining an internal fluid reservoir and further defining a rivet receiving portion and a rivet engaging member, the housing further including a tubing connector configured to connect to a tubing for the movement of fluid into and out of the internal fluid reservoir. The mesh layer may be positioned beneath the housing and may define a plurality of spaces. The mesh rivet may engage the rivet engaging member to hold the mesh rivet in place while holding the mesh layer between a base of the mesh rivet and the housing of the access port.

Abstract: Methods of performing a power injection procedure are described. One method includes taking an x-ray of a subcutaneously implanted access port in a patient to determine whether the access port includes a radiographic feature indicating that the access port is suitable for flowing fluid at a rate of at least about 1 milliliter per second through the access port, identifying the indicating radiographic feature on the x-ray, and flowing a fluid through the access port at a rate of at least about 1 milliliter per second.

Abstract: An implantable device for facilitating the healing of voids in bone, cartilage and soft tissue is disclosed. In one embodiment, the device is arranged for the local delivery of therapeutic agent. A preferred embodiment is a porous resorbable implant, wherein the therapy delivery may be localized in nature, rather than systemic, such that higher doses at the target site may be allowed than would be tolerable by the body systemically.

Abstract: A low-profile access port for subcutaneous implantation within the body of a patient is disclosed. The access port includes a receiving cup that provides a relatively large subcutaneous target to enable a catheter-bearing needle to access the port without difficulty. In addition, the access port includes a valve/seal assembly to permit pressurized fluid injection through the port while preventing backflow. In one embodiment, therefore, a low-profile access port comprises a body including a conduit with an inlet port at a proximal end thereof, and a receiving cup. The receiving cup is concavely shaped to direct a catheter-bearing needle into the conduit via the inlet port. The receiving cup is oriented substantially toward a skin surface when subcutaneously implanted within the patient to ease needle impingement thereon. A valve/seal assembly disposed in the conduit enables passage of the catheter therethrough while preventing fluid backflow.

Abstract: Implantable infusion devices configured to improve fill and evacuation procedures.

Abstract: A method for replenishing gas in a subcutaneously implanted medical device containing functional cells comprising: inserting at least one needle, adopted to penetrate the skin and connecting a subcutaneously implanted medical device; connecting the inserted at least one needle to a gas replenishing apparatus; extracting gas from a gas reservoir in the implanted device into the gas replenishing apparatus; sensing oxygen level in the extracted gas; calculating the amount of gas needed for replenishing oxygen in the reservoir based on the sensed oxygen level in the extracted gas; and supplying gas from a gas tank in the gas replenishing apparatus to the gas reservoir in the implanted device.

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: 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: A medical device system comprises a reservoir configured to store a therapeutic fluid and a medical pump configured to deliver the therapeutic fluid from the reservoir to a patient. The system also comprises a reservoir fill level detector configured to detect a fill status of the reservoir, the reservoir fill level detector including a contact pad operably attached to the reservoir whereby the contact pad moves in a predetermined path during the emptying and filling of the reservoir. A resistor strip mounted on the inside of the chamber is in continual contact with the contact pad and the resistance of an electric current passed through the resistor strip is monitored by a processor to determine the position of a selected portion of the reservoir. The position of the reservoir is directly related to the fill status.

Abstract: The present invention provides a system for attaching a fluid access port to a patient. The system generally comprises an implantable access port and method for attaching an access port to a patient. In addition, a tube guard, tube shroud, tissue guard, porous coupling member and a prefabricated mesh member may be attached to the access port. For example, the prefabricated mesh may be coupled to the access port to facilitate securing the access port to the tissue of the patient.

Abstract: An apparatus and method for positioning a barrier to cell ingrowth on the exterior surface of a port being implanted under the skin of a patient is provided. The barrier is formed by a film sheet configured to form a cover of the exterior surface of the port and remain mounted thereon in an as-used position. So engaged the film forms a barrier to cell ingrowth upon the port and additionally positions cell growth inhibitors on the exposed surface of the film adjacent to the surrounding cells. Engagement of the film to the port is accomplished by one or a combination of elastic contraction, heat shrinking or adhesive.