Abstract: Methods and apparatus for measuring pressure in a patient are provided which may include any number of features. One feature is a pressure measurement system comprising a pressure source, a compliant bladder, a catheter in communication with the pressure source, pressure sensors, and a controller configured to determine a pressure within the compliant bladder. The pressure measurement system can inflate the compliant bladder with gas or air to determine a pressure within a patient. In one embodiment, the pressure measurement system measures pressure within a peritoneal cavity.

Abstract: A pump is disclosed that comprises a primary control unit comprising a first processor and one or more modular pumping units removably docked to the primary control unit. Each modular pumping unit comprises a pumping mechanism and a second processor configured to control the pumping mechanism and communicate with the first processor. The modular pumping unit is configured to manipulate a portion of a fluid delivery set to pump a fluid. The first processor and the second processor are configured to exchange one or more operating parameters when the modular pumping unit is docked to the primary control unit. The modular pumping unit is configured to pump the fluid after being undocked.

Abstract: A venous access port assembly (10) having a housing (12), a septum (14), a discharge stem (16) at a distal end thereof for connection to a catheter (50), and an interior chamber (18). The housing includes a pair of recesses (28) along both sides thereof between the distal end and a proximal port end (24), where the recesses facilitate pushing the assembly by the practitioner into a subcutaneous pocket (104) of a patient (100) for implantation into the pocket.

Abstract: A device (100) for delivering a medicament into a patient's body by injection into or through the patient's skin includes a body (104, 116) having a reservoir (160) disposed therein for containing the medicament, an injection needle (152) for penetrating the skin of the patient, the needle (152) having a lumen and communicating with the reservoir (160), and a pressurizing system for pressurizing the reservoir (160). The device also includes indicator means (124) visible outside the device (100) for indicating that delivery of the medicament is substantially complete.

Abstract: A method and device are disclosed for preventing a needle stick hazard in the event of a collapse of a protective needle flap of a portable drug pump. The device may include a needle guide, a secure space and/or a shield. A point of a needle is optionally deflected into a secure space upon collapse of the protective flap. The space may optionally be shielded. Optionally, the support linking the needle to the pump may pivot and/or translate. Optionally, there may be an exposing position wherein the needle protrudes through an opening in the flap. Optionally, the opening may be non-circular.

Abstract: Methods and systems of maintaining, evaluating, and providing therapy to a lung ex vivo. The methods and systems involve positioning the lung in an ex vivo perfusion circuit; circulating a perfusion fluid through the lung, the fluid entering the lung through a pulmonary artery interface and leaving the lung through a left atrial interface; and ventilating the lung by flowing a ventilation gas through a tracheal interface. Maintaining the lung for extended periods involves causing the lung to rebreath a captive volume of air, and reaching an equilibrium state between the perfusion fluid and the ventilation gas. Evaluating the gas exchange capability of the lung involves deoxygenating the perfusion fluid and measuring a time taken to reoxygenate the perfusion fluid by ventilating the lung with an oxygenation gas.

Abstract: An implantable prosthesis with at least one fenestration in a side wall of that prosthesis is disclosed. The fenestration provides an access port through which a medical device (such as a needle or a cannula) can be directed to enable access to the lumen of the blood vessel which the prosthesis is supporting.

Abstract: A fluid delivery device comprising a fluid reservoir; a transcutaneous access tool fluidly coupled to the fluid reservoir; and a drive mechanism for driving fluid from the reservoir, the drive mechanism comprising a plunger received in the reservoir; a leadscrew extending from the plunger; a nut threadably engaged with the leadscrew; a drive wheel; and a clutch mechanism coupled to the drive wheel, wherein the clutch mechanism is configured to allow the nut to pass through when disengaged and is configured to grip the nut when engaged such that the drive wheel rotates the nut to advance the drive rod and the plunger into the reservoir.

Abstract: An implantable access port for use in transferring fluid transdermally between an external fluid storage or dispensing device and a site within a patient is disclosed. The access port includes a body, at least two reservoirs defined within the access port body, and at least one septum secured to the body and enclosing the reservoirs within the body. The access port also includes reservoir outlets defined within the reservoirs. The access port also has body conduits defined within the body and in fluid communication with the reservoir outlets and external openings defined in the exterior of the body. An implantable access port and system for use in apheresis is also provided that includes an implantable access port, at least one needle, and a catheter that is fluidly connected to the access port.

Abstract: In certain embodiments, a vial adaptor comprises a housing member, a connector configured to couple the adaptor with a vial, and an extractor channel formed in the housing member. The extractor channel is configured to facilitate withdrawal of fluid from the vial when the adaptor is coupled to the vial. In some embodiments, an anti-reflux valve is positioned within the extractor channel. The anti-reflux valve can be configured to impede or obstruct fluid returning to a fluid source after withdrawal of the fluid from the fluid source.

Abstract: The present invention relates to inhibiting or preventing infection and protecting against patency complications after a blood catheter has been inserted in a patient comprising administering to the device a pharmaceutically effective amount of a composition comprising (A) at least one taurinamide derivative, and (B) heparin at a low concentration.

Abstract: Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing a first intravascular device having a distal portion with a concave side, inserting the first device into the vascular lumen, positioning the distal portion in the vascular wall, and orienting the concave side of the distal portion toward the vascular lumen.

Abstract: An ultrasonic surgical device for performing a surgical procedure includes an elongated member having a proximal end and a distal end spaced along a longitudinal axis. The elongated member has an inner surface and an outer surface. The inner surface defines a passageway. A septum is configured to separate the passageway into a first conduit and a second conduit. A distal end of the second conduit terminates before a distal end of the first conduit to form a stepped configuration. An ultrasonic-driven cutting blade is disposed within the second conduit and is configured for cutting tissue such that the cutting blade vibrates ultrasonically to cut tissue. The distal end of the first conduit includes an outlet configured for delivering material to a surgical site and the distal end of the second conduit includes an inlet configured for aspirating the surgical site.

Abstract: A one time use cleansing device for inhibiting catheter associated urinary tract infections. An absorbent body includes a plurality of fingerlings extending outwardly from a front side of the absorbent body. First and second wings extend from a back side of the absorbent body. One or more liquid containing frangible vials are disposed between the first and second wings such that squeezing the wings together causes the vials to rupture, thereby releasing the contents of the vials into the absorbent body. The absorbent body and/or the one or more vials contain a cleansing agent of castile soap and tea tree oil designed to aid in the inhibition and/or prevention of catheter associated urinary tract infections (CAUTIs).

Abstract: An intravascular catheter for peri-vascular and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial and/or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall.

Abstract: A device for inserting a needle used to introduce a cannula can include a housing including a closed end, an open end, and an arm including a tab extending from the open end, and a sleeve configured to be placed against the patient's skin, the sleeve defining a slot extending along a length of the sleeve, and a barb positioned adjacent to an end of the slot. The slot is sized to receive at least a portion of the arm and the tab of the housing so that the arm and the tab of the housing slides within the slot as the housing is moved relative to the sleeve, and the barb is positioned to engage the tab of the housing to limit movement of the housing relative to the sleeve. The device can also include a threaded portion of the housing extending towards the closed end of the housing.

Abstract: Embodiments of the invention include wound packing devices and methods of making and using the same. In an embodiment, the invention includes a wound packing device including a plurality of spacing elements capable of absorbing exudate, wherein the surface of the spacing elements resist colonization by microorganisms. The wound packing device can also include a connector connecting the plurality of spacing elements to one another. Other embodiments are also included herein.

Abstract: A medical sensor system which includes at least one sensor lead which can be implanted in the body of a human/animal, comprising two end sections, wherein the end sections are designed to be routed through two artificial openings in the surface of the body. The sensor lead includes, between the two end sections, at least one sensor for detecting a biological measured quantity. The sensor system furthermore includes at least one fastening element disposed on the surface of the body, which can be connected to the end sections guided through the body openings for affixing the implanted sensor lead, wherein the at least one fastening element comprises a device for processing sensor signals, and an energy source for supplying the sensor system with electrical energy.

Abstract: A needle assembly including a positive flush mechanism for use with a vascular access port. The needle assembly is configured to supply fluid to the port and to provide a positive flush to overcome negative pressures in the port that can potentially occur during withdrawal of the needle from the port.

Abstract: Generally described herein are apparatus, systems and methods related to a pre-loaded septum insertable in an access port housing for increasing the control of the compression within the septum and the interference between the septum and the housing. For example, a pair of washers having mating portions may be positioned on respective sides of a rubber septum and bent such that the mating portions of one of the washer are interlocked with the mating portions of the other washer, the interlocked portions forming a tight ring about the septum and generating lateral compression on the septum, thereby “loading” the septum. In addition, fluid seals made of a rubber material with lower durometer than the rubber septum may be used at the interface between the rubber septum and the housing to enhance the fluid sealing functionality while promoting the self-sealing features of the rubber septum.

Abstract: Tissue treatment systems include an actuator handle assembly coupled with a clamp assembly having a first jaw mechanism and a second jaw mechanism. A first jaw mechanism includes a first flexible boot, a first flexible ablation member coupled with the first flexible boot, and a first rotatable jawbone disposed within the first flexible boot. A second jaw mechanism comprises a second flexible boot, a second flexible ablation member coupled with the second flexible boot, and a second rotatable jawbone disposed within the second flexible boot.

Abstract: An agent delivery catheter and method configured to deliver an agent to an inner surface of a patient's body lumen wall by forming a funnel shaped agent containment chamber around at least one portion of the inner surface of the body lumen wall, while minimizing ischemic conditions during the procedure.

Abstract: Implantable devices and methods for delivering drugs and other substances to locations within the body of a human or animal subject to treat or diagnose sinusitis and a variety of other disorders. The invention includes implantable substance delivery devices that comprise reservoirs and barriers that control the rate at which substances pass out of the reservoirs. The delivery devices may be advanced into the body using guidewires, catheters, ports, introducers and other access apparatus. In some embodiments the delivery devices may be loaded with one or more desired substance before their introduction into the body. In other embodiments the delivery devices are loaded and/or reloaded with a desired substance after the delivery device has been introduced into the body.

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 access port assembly having an attachable catheter allows for inserting a guidewire into the catheter to aid in the placement of the integral catheter while still attached to the access port assembly. A method is described for placing an access port fixedly attached to a catheter into a patient using a guidewire inserted into the catheter.

Abstract: Fluid delivery devices and methods for delivering fluid to the body of the patient are disclosed which include a housing having an upper wall and a lower wall defining an opening, a well-arrangement mechanism configured to be disposed inside the housing and between the upper wall and the lower wall and including a tubular member having a bore, wherein the bore is configured to be disposed within the opening, a penetrating cartridge for delivery of therapeutic fluid to the body of the patient, wherein the penetrating cartridge is configured to engage the bore following its insertion through the upper opening and the lower opening, and a tilting tool configured to rotate the bore prior to insertion of the penetrating cartridge, wherein therapeutic fluid is configured to be delivered through the tubular member into the penetrating cartridge into the body of the patient when the penetrating cartridge engages the bore.

Abstract: Medical device are provided for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups.

Abstract: The present invention generally relates to intraocular shunts, and in particular, to intraocular shunts configured to form a drainage pathway between the anterior chamber and the intra-Tenon's space.

Abstract: The present invention relates to a drug delivery device for dispensing a dose of a medicament, comprising: a first housing component, and a second housing component welded with the first housing component by means of at least one induction heatable component.

Abstract: An implantable medical device for performing therapy or monitoring a physiological condition. The device includes components for connecting the device to a trunk line. These components connect the device to the trunk line in such way that the components move over the trunk line. Internal to these components are conductors, including a coil, that are arranged to complementary inductively exchange signals with conductors internal to the trunk line. As a result of this inductive signal exchange the implantable medical device at least one of: receives power signals; receives signals that regulate the operation of the device; or transmits signal representative of the physiological state monitored by the device.

Abstract: A comprehensive system for gut in vivo exploration, discovery, characterization, research, diagnostics, and treatment comprising three different ingestible capsules and their associated methodologies, is provided for medical research and patient care. The system of tools is focused on discovery of causes of gut-based illnesses, treating, and curing them. The capsules perform unique functions, and as an in vivo healthcare system, provide for sampling, testing or diagnosing gut processes as a function of the length of the gut “x” and at any point in time “t”, including simultaneous chemical substance sampling and testing, along with the associated microbes. The in vivo system allows medications or system perturbation substances delivery, in a prescribed manner to the point of interest, and the resulting substances and microbes are simultaneously sampled upstream and downstream at the exact point and time of delivery.

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: The invention is a tympanic membrane pressure equalization tube. The tube has a distal end and a proximal end and a tube lumen. A medial flange is located at the distal end of the tube and has 2 or more retention elements and a space between each retention element. A lateral flange is located at the proximal end of the tube. The outside diameter of the medial flange is greater than the outside diameter of the lateral flange and the diameter of the medial flange is between about 2.0 and 5.0 mm and the diameter of the lateral flange is between about 1.75 mm and 4.0 mm.

Abstract: This document discusses, among other things, an apparatus comprising a lacrimal implant insertable at least partially into a lacrimal punctum. The lacrimal implant comprises an implant core, and an implant body. The implant body includes a cavity sized and shaped to receive the implant core. At least one of the implant core and the implant cavity includes a detection device configured to allow automatic detection of the lacrimal implant with a separate detector device.

Abstract: A wound treatment device comprises a wound surface contacting plug and a cover for covering the wound surface and the plug, wherein said plug consists of a flat textile isolating material comprising at least one first surface layer, one second surface layer and one intermediate space arranged between said surface layers. At least the first surface layer is provided with a biocompatible surface and a structure which enables a liquid to pass and prevents a wound tissue from growing in said structure. The intermediate space is provided with isolating threads elastically holding the first surface layer and the second surface layer at a certain distance from each other.

Abstract: This invention is related to the use of polyurethane-based polymer as a drug delivery device to deliver biologically active compounds at a constant rate for an extended period of time and methods of manufactures thereof. The device is very biocompatible and biostable, and is useful as an implant in patients (humans and animals) for the delivery of appropriate bioactive substances to tissues or organs.

Abstract: The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent, an antioxidant, and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In some embodiments, the additive is a liquid. In other embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has one or more hydroxyl, amino, carbonyl, carboxyl, acid, amide or ester groups.

Abstract: A therapeutic delivery device comprises a layer of biodegradable material wound into a plurality of windings, the plurality of windings comprising an outermost winding defining an internal volume and winding pairs including a first winding pair and a second winding pair. A first therapeutic mass is incorporated in or on the layer the first winding pair and a second therapeutic mass is incorporated in or on the layer along the second winding pair. In one implementation, at least one volume of gas is captured within the internal volume and occupies at least 50% of the internal volume. In one implementation, the windings include perforations.

Abstract: A female urethral catheterization assisting device may include a handle, an elongated shaft and a catheter holding mechanism. The catheter holding mechanism may hold a catheter securely so that a patient may position, orient and insert a catheter into the patient's urethra. The handle and elongated shaft assist in positioning, orienting and inserting the catheter by extending the patient's reach.

Abstract: A thrombectomy catheter includes a catheter body having a catheter lumen. An outflow orifice is positioned along a catheter perimeter. A fluid jet emanator communicates with a high pressure tube. The fluid jet emanator includes at least one jet orifice for directing a fluid jet from the fluid jet emanator through the catheter lumen toward the outflow orifice. The fluid jet emanator provides a jet stream from the catheter body through the outflow orifice. The jet stream includes first and second stream portions. An entrainment fluid flow circuit includes at least the first stream portion, and the entrainment fluid flow circuit entrains particulate and macerates the particulate therein. An exhaust fluid flow path includes the second stream portion, and the exhaust fluid flow path draws entrained particulate from the entrainment fluid flow circuit at a location exterior to the catheter body and directs it toward the catheter proximal portion.

Abstract: The present invention improves significantly the success rate of lithotripsy and reduces the risk of tissue damage, by injecting a temporary plug in front, and optionally behind a concretion (for extracorporeal lithotripsy) or behind a concretion (for intracorporeal lithotripsy). One aspect of the present invention relates to injecting an inverse thermosensitive polymer solution into a lumen, thereby preventing the migration of a concretion, or its fragments, upon extracorporeal or intracorporeal lithotripsy.

Abstract: The present disclosure relates to a packaged urinary catheter. The catheter includes a conduit having a proximal end and a distal end. The distal end includes at least one aperture for receiving urine from the bladder. The catheter is contained within a sleeve having a length, a width, and a size configured to receive the catheter. According to one embodiment, the catheter and the sleeve may be arranged in a helical coil. The outer surface of the catheter may have a lubricious and/or an antimicrobial coating.

Abstract: Described herein is an apparatus to insert an implantable therapeutic device into a patient. The apparatus includes a proximal handle (210) and a distal placement portion (220) coupled to the proximal handle and configured to hold the implantable therapeutic device. The distal placement portion includes a first side (222) having a first engagement structure (251) at a distal end of the first side, the first engagement structure configured to surround at least a first portion of a proximal end region of the implantable therapeutic device. The distal placement portion includes a second, opposite side (224) having a second engagement structure (253) at a distal end of the second side, the second engagement structure configured to surround at least a second, opposite portion of the proximal end region of the implantable therapeutic device.

Abstract: A system for harvesting a fibrin clot and depositing that fibrin clot into a wound site during a surgical procedure, the system comprising: (i) blood drawing apparatus for drawing blood; (ii) extraction apparatus for extracting fibrin from blood so as to form a fibrin clot; (iii) configuring apparatus for molding, cutting and shaping the fibrin clot into a desired configuration; and (iv) dispensing apparatus for reliably and controllably dispensing the fibrin clot at a selected location in the body.

Abstract: A medicated module comprising a connecting body configured for attachment to a drug delivery device. A first needle is fixed within the connecting body and an outer body operatively coupled to the connecting body. A needle guard operatively coupled to the outer body and a biasing member positioned between the outer body and needle guard. A second needle fixed within the outer body and a recess within the connecting body defines a reservoir. The reservoir contains at least one dose of a medicament and is configured for fluid communication with the first and second needle.

Abstract: The invention provides multi-chamber encapsulated cell therapy cartridge devices that are capable of delivering biologically active molecules as well as methods of using these devices.

Abstract: A malleable cannula having multiple lumens, constrained at the proximal end portion to provide rigidity and malleable at the distal end portion. The cannula has a combination of flexibility and stiffness that assists in accessing body passageways without kinking.

Abstract: A catheter assembly is provided having a conical diffuser tip for use in rapid infusion procedures. The conical diffuser tip provides a flared opening whereby the velocity of an infusant is decreased as the infusant travels through the catheter tip and exits into the vascular system of a patient. This decrease in velocity proportionately reduces the backpressure and/or recoil force of the catheter assembly thereby permitting the use of higher infusion rates. The catheter tip is introduced into the vasculature of a patient via a splittable introducer needle.

Abstract: A suction tip for a surgical instrument includes a hollow housing having a top flat wall and a bottom flat wall and including a proximal end and a distal end. The distal end has a widened tip portion that is wider than the proximal end. The distal end may have a plurality of suction ports located at its front, top, right side and left side of the widened tip portion. Furthermore a ledge portion may protrude outwardly past a terminal end of the top flat wall to provide a clear space between the suction ports and tissue for evacuation of fluid in the clear space. Furthermore, the ledge portion which protrude outwardly may have bended tip in desire degrees and shapes.

Abstract: Methods and apparatus of providing a joint replacement parts with a pharmaceutical delivery system is provided. The pharmaceutical delivery system is placed within the joint replacement parts to provide, over a period of time, sustained release of a controlled concentration of pharmaceuticals within the joint space of the joint replacement and to produce a local or systemic physiological of pharmacological effect.