Abstract: The present invention is generally directed to medical devices, and more specifically to medical devices that are at least partially insertable or implantable into the body of a patient. The medical devices generally comprise (a) a therapeutic agent, more typically, a high-molecular-weight therapeutic agent, and (b) at least one polymeric layer, which typically acts to control the release of the therapeutic agent from the medical device. Also disclosed herein are methods of making such medical devices.

Abstract: The present invention includes an introducer sheath. The sheath may comprise a first proximal elongated section having a first outer diameter and a first inner diameter, and a main body elongated section having a second inner diameter and a second outer diameter, wherein the second outer diameter is larger than the first outer diameter. The sheath may further include a distal section having an outer wall that tapers from the second outer diameter of the main body elongated section to a smaller distal outer diameter.

Abstract: A catheter having an outer profile which is formed such that a path length along an outer surface of the catheter is greater than the corresponding length of the catheter, and to a method for determining the shape of a catheter, and wherein the elasticity and/or conductivity of the tissue into which the catheter is to be introduced is taken into account in order to determine the outer profile of the catheter.

Abstract: A catheter system and a method for accessing the bile duct are provided. The catheter system includes an elongate shaft having a proximal portion and a distal portion. The catheter also includes a first lumen extending at least partially through the elongate shaft, a distal portion of the first lumen extending generally parallel to a longitudinal axis of the elongate shaft and a distal port operably connected to the first lumen. The catheter system also includes a second lumen extending at least partially through the elongate shaft and a side port operably connected to the second lumen, the side port positioned proximal to the distal port and operably connected to the second lumen. The second lumen includes an angled wall portion adjacent to the side port. A marker is included on the distal portion of the elongate shaft, the marker configured to indicate the position of the side port.

Abstract: Embodiments of the invention provide apparatus, methods and systems for delivering treatments and for medications to the site of an aneurysm (SOA). One embodiment of a method comprises delivering a neural growth stimulating factor (NGSF) to the site of the aneurysm to grow new nerve cells and/or stimulate the regeneration of damaged nerve cells. The NGSF may be delivered in a carrier such as a gel which can be selected to allow for long term delivery of the NGSF to the SOA. In many embodiments, the NGSF may be delivered to the SOA using a micro-catheter based system which includes a microcatheter that can be advanced in the cerebral vasculature. The microcatheter may also be used to delivery occlusive element to the SOA such as occlusive coils or balloon which promote clotting and reduce bleeding at the SOA and together with the carrier allow for long term release of NGSF.

Abstract: Catheters and a method of preparation thereof comprising a catheter body and at least one connector. The catheter body has an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon, the hydrophilic polymer layer has an average dry thickness of at least about 50 nanometers.

Abstract: A dual cannula apparatus is provided for insertion into the gastrointestinal tract. One end of a first outer cannula is placed within the small intestine providing a guide for advancement of a second inner cannula. The second inner cannula extends beyond the first outer cannula and provides a source of nutritional support and pharmacological therapy. The first outer cannula has a radiopaque tip to facilitate placement thereof under x-ray or fluoroscopic guidance. The first outer cannula can also be provided with a flared end for maintenance with the naris. The second inner cannula includes one or more openings for flow of the nutritional support or pharmacological therapy into the small intestine.

Abstract: Disclosed herein is a strain relief having a plurality of enclosing parts arranged in an axial direction and enclosing a longitudinal axis of the strain relief. A space portion can be formed between adjacent enclosing parts so that the strain relief is freely bendable. In the strain relief, the adjacent enclosing parts are interconnected, and one or both of opposed surfaces of the adjacent enclosing parts can be provided with a projection that projects in a direction substantially parallel with the longitudinal axis.

Abstract: A catheter sheath comprises a tubular member connected to a catheter handle, the tubular sheath including one or more electrical conductors and one or more electrode rings attached to the tip of the tubular member. The tubular member further includes at least one opening that allows the one or more electrical conductor to be electrically connected to the one or more electrode rings. The electrode ring is slid over the tubular member so as to cover the opening. The tubular member and the electrode ring are subjected to heat treatment by induction heating so that the material of the tubular member melts locally around the electrode ring to form a seal between the tubular member and the electrode ring.

Abstract: Herein are described components and use of an adjustable device delivery system including an adjustable internal door which allows angled deployment of medical devices, non-medical devices and electromagnetic radiation. In one embodiment, a slotted outer cannula is used with an inner drive cannula to guide the motion of an adjustable interior door that allows delivery of devices, such as medical instruments, at user-defined angles. The invention also provides device delivery systems that permit withdrawal of the adjustable device delivery system without disruption of a device placed therewith. The device delivery systems of the invention are provided having a steering system that permits exact control of the angle of the adjustable internal door while providing support against longitudinal forces.

Abstract: Catheter assemblies are generally discussed herein with particular discussions extended to catheter assemblies having a tip protector, a valve, a valve opener, and optionally a needle wiper. The valve opener is disposed inside a catheter hub and is configured to be pushed by an IV set luer connector to open a valve following successful catheterization to pass fluids or other solutions through the catheter. A tip protector is incorporated to block the needle tip and prevent the same from accidental needle stick. A wiper is optionally included to wipe blood deposits on the needle when the same is retracted from the catheter.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: A catheter includes a handle, a catheter sheath having at least one conductor within a lumen of the catheter sheath, and a stylet received within the catheter sheath. The catheter sheath is fabricated by providing a tubular member, forming an aperture in the wall of the tubular member at the distal part of the tubular member and inserting a conductor into the lumen of the tubular member. The exposed distal end of the conductor is attached to an electrode, which is then mounted onto an external surface of the tubular member to cover the aperture. The tubular member is then treated by heat to seal the electrode.

Abstract: A catheter includes a catheter sheath, and a handle. The handle includes an electrical connector its proximal end for connecting the catheter to standard electrical devices such as a typical monitoring device. The catheter handle houses an electrical connector assembly. The electrical connector assembly includes a first connector member to which electrical conductors of a catheter sheath are connected and a second connector member, which is further connected to the connector integrated at the proximal end of the catheter handle. The first connector member is received in a socket of the second connector member in a clip-in manner.

Abstract: Bioactive, hydroforming luminal liner compositions are formed of high molecular weight crystalline, absorbable copolyesters dissolved in a liquid derivative of a polyether glycol that undergoes transformation into a tissue-adhering, resilient interior cover or liner for the controlled release of its bioactive payload at clinically compromised conduits in humans as in the case of bacteria- and yeast-infected vaginal canals, esophagi, and arteries following angioplasty.

Abstract: Featured is a method for instilling one or more bioactive agents into ocular tissue within an eye of a patient for the treatment of an ocular condition, the method comprising concurrently using at least two of the following bioactive agent delivery methods (A)-(C): (A) implanting a sustained release delivery device comprising one or more bioactive agents in a posterior region of the eye so that it delivers the one or more bioactive agents into the vitreous humor of the eye; (B) instilling (e.g., injecting or implanting) one or more bioactive agents subretinally; and (C) instilling (e.g., injecting or delivering by ocular iontophoresis) one or more bioactive agents into the vitreous humor of the eye.

Abstract: An infusion catheter includes an elongate catheter body having a longitudinally extending fluid supply passage, and a plurality of stellate side ports for infusing a treatment fluid from the fluid supply passage into a body lumen of a passage. Each of the stellate side ports is defined by sets of at least three convergent leaves having an attached basal edge, a terminal tip, and first and second free edges extending between the attached basal edge and the terminal tip. Making an infusion catheter includes forming a plurality of stellate side ports in fluid communication with a fluid supply passage of an elongate catheter body, each of the stellate side ports being defined by a set of at least three convergent leaves, and setting an infusion length of the infusion catheter during the forming step via spacing the stellate side ports between proximal and distal ends of the elongate catheter body.

Abstract: A solid stepped needle delivers a disc shunt bridging between muscle and a degenerated disc, drawing blood plasma from muscle into the degenerated disc to alleviate back pain and regenerate the disc. The device further includes pull lines attached to the ends of the disc shunt for withdrawing and repositioning the stepped needle during shunt delivery.

Abstract: The present invention relates to a device comprising a capillary tube assembly (100) having a proximal (20) end and a distal (30) end, comprising: a think walled capillary tube shaft (10) disposed with a capillary lumen (12) extending from an open proximal (20) end to an open distal (30) end, and a fluidic adapter (40) at the proximal (20) end in fluid connection the capillary tube lumen (12), wherein the capillary tube shaft (10) is adapted for dismountable insertion into a fluid-carrying lumen (212) of a bodily invasive tube (200), and the adapter (40) provides fluidic access to the capillary tube lumen (12) that is fluidically isolated from access to the invasive tube lumen (212). It further relates to an applicator package comprising the capillary tube assembly (100) and an applicator (510).

Abstract: A balloon catheter having a multilayer catheter shaft is formed to have an inner layer and an outer layer, where the inner layer and outer layer are selected from materials that enhance the pushability of the catheter while preserving the flexibility. Using a combination of a high Shore D duromater value material and a lower Shore D duromater value material, various combinations of multilayer catheter shafts are disclosed utilizing different glass transition temperatures and block copolyamides to obtain the desired characteristics.

Abstract: A system for medical tubing detection and management could include an infusion manifold housing having at least one fluid channel therethrough. At least one fluid input port could be provided in the infusion manifold housing and could be configured to connect fluidically to illuminated medical tubing and communicate with the at least one fluid channel through the infusion manifold housing. A fluid output port could be provided in the infusion manifold housing and be configured to be in fluidic communication with the at least one fluid channel through the infusion manifold housing. At least one photosensor could be provided in the infusion manifold housing and be configured to receive light from the illuminated medical tubing; and the fluid output port could be configured to connect fluidically to fluid output tubing.

Abstract: A system and method of treating urinary incontinence including a catheter and injection guide operatively disposed together. At least one needle is operatively disposed within at least one lumen and at least one channel extending through the catheter and injection guide respectively. The injection guide is transformable from a pre-injection configuration for placement in the bladder to an injection configuration for injection of a pharmaceutical such as botulinum toxin into the bladder tissue. Upon introduction of the pharmaceutical to the bladder tissue, symptoms of incontinence are alleviated.

Abstract: A surgical access device is provided having a cannula and obturator. The cannula has a housing and tube section with an anchor located about the tube section. The obturator has a mechanism to deploy the anchor and adjust the cannula length. The anchor is moveable between a deployed and undeployed state where the undeployed state facilitates insertion and removal of the access device and the deployed state assists in fixation of the cannula in an anatomic structure. Anchor deployment is independent of cannula length adjustment.

Abstract: Methods and devices for providing improved ultrasound visibility of medical devices intended for intravascular use are described. The inclusion of gas/solid boundary regions within a medical devices improves the resolution of the device under ultrasound visualization. Gas/solid boundary regions may be provided through the use of embedded gas-filled microlumens, microwells, or enclosed pockets within the medical device.

Abstract: Catheter and methods for designing, making, and using catheters are disclosed. An example catheter is a balloon catheter. The balloon catheter may include a proximal shaft. The proximal shaft may be a bare metal hypotube having a skew value of ?1.0 to ?2.5. A midshaft may be attached to the proximal shaft. A distal shaft may be attached to the midshaft. A balloon may be coupled to the distal shaft. An inflation lumen may be defined that extends from the proximal shaft, through the midshaft, and into the distal shaft. The inflation lumen may be in fluid communication with the balloon.

Abstract: When the intravascular drug elution-type catheter is inserted into a blood vessel, the elastically deformable portion is formed into a deflated shape and accommodated in the first lumen of the catheter body. When the top end side of the catheter body reaches near a damaged blood vessel wall, the shaft is inserted into the catheter body, the elastically deformable portion is pushed out from the first lumen of the catheter body to elastically return to an inflated shape from the deflated shape, and then the drug holding film presses the blood vessel wall. Thus, the drug eluted from the drug holding film can be infiltrated into the blood vessel wall, The state where the drug holding film is pressed against the blood vessel wall can be maintained without blocking the blood flow toward the peripheral side.

Abstract: Devices, methods and kits which, when installed or used, access, aspire, dilate, insufflate, drain or deliver fluid medicaments to, or place a patency device within a sinus area, such as a maxillary sinus or a maxillary sinus ostium. The device can include a hollow catheter and probe, and can be configured to permit gradual and incremental probe extension. The device can be constructed to enhance the precision and maneuverability within the nasal and sinus passageways, while also accommodating the natural anatomical geometry of a targeted paranasal treatment site. For example, the present treatment and placement device can accomplish access to the maxillary sinus ostium by utilizing an uncinate process to guide a probe tip into the ostium in a retrograde manner. The probe can be slidably, bi-directionally or co-axially positioned within the catheter. A distal portion of the probe can be biased away from a longitudinal axis of the catheter.

Abstract: A surgical instrument for minimally invasive surgery, having a handle, a shaft and an actuating part, as well as a gastight cover surrounding the shaft, wherein the cover is provided with a coupler that has a feed-through opening with a lockable seal, through which feed-through opening, after the seal is unlocked, the shaft with the actuating part can reach.

Abstract: Disclosed herein are methods and devices for processing a biomaterial in a closed system and administering the processed biomaterial to a subject.

Abstract: An infusion pump system is described that increases patient comfort and convenience. The infusion pump system includes an infusion site interface that is releasably connected to an infusion pump body, and has no tubing associated between the infusion site interface and the pump body. The infusion pump body may include a carrier frame that may be adhered to the skin of a user.

Abstract: The invention provides surgical devices that provide access to the sub-retinal space using delicate traction to hold the sensory retina to create and maintain a patent sub-retinal space of sufficient size to introduce and perform treatments on the eye. Such treatments may include the introduction of illumination or imaging agents or tools, surgical tools, the infusion of pharmaceutical or biological agents, and the placement of grafts, transplants or implants and the closure of the site through the delivery of a sealant.

Abstract: Medical implants are provided which release an anthracycline, fluoropyrimidine, folic acid antagonist, podophylotoxin, camptothecin, hydroxyurea, and/or platinum complex, thereby inhibiting or reducing the incidence of infection associated with the implant.

Abstract: The disclosure provides a catheter for positioning in a contralateral femoral approach in highly angulated iliac bifurcations. The catheter comprises an elongate shaft, an adjustable element, and a wire entrance port on the elongate shaft. The elongate shaft has a proximal portion, an intermediate portion, a curved portion, and a distal portion. The curved portion connects the intermediate portion and the distal portion. The adjustable element is configured to encompass the distal portion and the intermediate portion together in a closed position. The adjustable element can be removed away from the distal portion permitting the distal portion in an open position. The wire entrance port is disposed in the intermediate portion near the curved portion. The distal portion is biased to be spaced away from the intermediate portion in the open position. The adjustable element is connected to an operating wire configured to advance and retreat through the wire entrance port.

Abstract: Catheter assemblies are generally discussed herein with particular discussions extended to catheter assemblies having a tip protector, a valve, a valve opener, and optionally a needle wiper. The valve opener is disposed inside a catheter hub and is configured to be pushed by an IV set luer connector to open a valve following successful catheterization to pass fluids or other solutions through the catheter. A tip protector is incorporated to block the needle tip and prevent the same from accidental needle stick. A wiper is optionally included to wipe blood deposits on the needle when the same is retracted from the catheter.

Abstract: A balloon catheter comprising a catheter (3) and a balloon (7) located at a distal end (5) of the catheter (3). A plurality of measuring electrodes (12) formed on a primary substrate (17) extend around the catheter (3) within the balloon (7). The primary substrate (17) is formed by a portion of a flexible resilient membrane (25) which also forms a secondary substrate (19). The measuring electrodes (12) are formed on the primary substrate (17) by first electrically conductive tracks (27) and second electrically conductive tracks (28) which are electrically connected to the first electrically conductive tracks (27) are simultaneously formed on the secondary substrate (19). The membrane (25) is coiled to form a roll, and the primary substrate (17) is also coiled around the rolled secondary substrate (19).

Abstract: A tip assembly for a liquefaction surgical handpiece. The tip assembly has an inner connector and an outer cap. The outer cap contains an external thread for attaching the tip assembly to a handpiece. The inner housing contains an alignment tab and fits within the outer cap so as to allow rotation of the inner connector within the outer cap. The inner and outer liquefaction tip tubes are frictionally fit into a bore in the inner connector. The proximal end of the inner housing contains a gasket that seal the inner housing against the handpiece.

Abstract: One aspect of the invention is a method to vent gas from a body cavity during an endoscopic procedure. A body cavity is in fluid communication with an exhaust gas inlet of a vacuum break device. The vacuum break device has a chamber in fluid communication with both the inlet and an outlet. The chamber may comprise one or more openings in fluid communication with the atmosphere. A conduit in fluid communication with the exhaust gas outlet may be connected directly or indirectly to a suction source. The suction source may be activated.

Abstract: A tearaway introducer sheath assembly (10) for use in implantation of a catheter into a patient, having an elongated polytetrafluoroethylene sheath tube (12) and a proximal polyethylene hub component (16). The hub comprises two halves (22) insert molded about the sheath tube proximal end and joined to each other by frangible webs (28) enabling manual splitting. At least one pair of opposed holes (42) is formed through the tube proximal end portion 44, and a polyethylene liner (46) is inserted into the tube's proximal end portion. The polyethylene flows into the at least one pair of holes (42) to fuse with the liner, establishing a pair of physical joints (50?) integrally joining the liner (46) to a respective hub half (22). Upon manual splitting of the hub halves, the sheath tube easily splits along its length as a result of a property of the polytetrafluoroethylene material.

Abstract: An exemplary medical device for subcutaneous disposal at least partially within a patient is disclosed, comprising an antimicrobial material comprising at least one metal and an agent that inhibits diffusion of the at least one metal from the antimicrobial material. The antimicrobial material comprises a coating formed over at least a portion of a surface of the medical device. Methods for preparing medical devices and methods of using the medical devices having the antimicrobial material are also disclosed.

Abstract: A catheter comprising a body wall separator for preventing the occlusion of catheter openings by body tissues when the catheter is placed in the body of a subject. The inventive catheter provides enhanced flow of fluids to and from the body. Methods of making and using the catheter, for drainage purposes for example, are also within the scope of the invention.

Abstract: An infusion system includes a disposable wearable infusion device and a filler device. The disposable infusion device has a body arranged to be adhered to a patient's skin and a reservoir for holding a liquid medicant to be infused into the patient. The filler device is arranged to detachably receive the infusion device body and to transfer a volume of the liquid medicant to the infusion device reservoir. The filler device may be part of a service device arranged to detachably receive the infusion device and which also includes a cannula driver and a cannula for providing the infusion device with a cannula and deploying the cannula to beneath a patient's skin.

Abstract: Systems and methods for temporarily pacing a patient's heart are provided. One system includes a hemostasis valve with an adjustable electrical connection, the adjustable electrical connection having one or more adjustable contacts. The adjustable contacts have a first, radially expanded configuration and a second, radially constricted configuration. In the radially constricted configuration, the adjustable contacts are configured to pierce through a layer of an elongate medical device that is disposed in the hemostasis valve. The elongate medical device has a distal electrode and a conductor extending along a portion of the elongate medical device. The adjustable contacts pierce through and make contact with the conductor, providing an electrical pathway to the distal electrode. Also provided are vascular access systems including hemostasis valve and a guide catheter, guide wire torquers with adjustable contacts and methods of temporarily pacing a patient's heart.

Abstract: A flow directional infusion device includes a filter valve located at the distal end of a catheter. The filter valve constrains delivery of an embolic agent through the catheter to the locus of the aneurysm. In order to provide such delivery, the valve includes a longitudinal opening, radial opening or is otherwise partially permeable in a direction of the aneurysm so that the embolic agent or a delivery element for such agent is limited toward the aneurysm. In addition, the filter valve permits and directs blood flow within the blood vessel about the aneurysm during the treatment without obstructing the vessel and without allowing retrograde flow of the embolic agent in the vessel upstream of the aneurysm.

Abstract: A catheter is adapted to exchange heat with a body fluid, such as blood, flowing in a body conduit, such as a blood vessel. The catheter includes a shaft with a heat exchange region disposed at its distal end. This region may include hollow fibers which are adapted to receive a remotely cooled heat exchange fluid preferably flowing in a direction counter to that of the body fluid. The hollow fibers enhance the surface area of contact, as well as the mixing of both the heat exchange fluid and the body fluid. The catheter can be positioned to produce hypothermia in a selective area of the body or alternatively positioned to systemically cool the entire body system.

Abstract: A method and apparatus for introducing a cardiac lead to an implantation site that includes a catheter body having an outer wall and a distal leader and having a proximal portion extending from the first proximal end to a second distal end. An inner member is positioned within an outer lumen of the catheter body and is spaced from the outer wall to form a first inner lumen for receiving a guide tool inserted therein and a second lumen for receiving the cardiac lead while the guide tool is positioned within the first inner lumen. A distal end of the inner member forms a first opening at a distal end of the first inner lumen and a second opening at a distal end of the second inner lumen, the first opening and the second opening positioned proximal the distal leader.

Abstract: A method of treating a disc that is leaking nucleus pulposus through at least one defect in the annulus fibrosus. The method includes injecting a fibrin sealant into the disc to reduce at least a portion of the at least one defect, wherein the fibrin sealant injected into the disc comprises an anesthetic, fibrinogen and an activating compound, wherein at least a portion of the fibrin forms after injection, with the proviso that a corticosteroid is absent from the fibrin sealant injected into the disc.

Abstract: Provided is a method of manufacturing a hollow microneedle structure. The method includes coating a hollow core having a predetermined section and being long in a lengthwise direction with a coating solution, and solidifying the coating solution to form a coating layer, depositing a metal seed layer on the coating layer, plating the seed metal layer with a metal to form a plated layer, cutting the hollow core having the plated layer at an inclination angle with respect to the lengthwise direction for form a surface inclination, and removing the hollow core and the coating layer to form a hollow microneedle structure. Thus, the hollow microneedle structure can be manufactured to have such diameter, length, hardness, and inclination angle as to minimize pain. By use of the hollow core, the microneedle structure can have vertical microneedles with a uniform inner diameter.

Abstract: A device for removing fluid from a first bodily cavity and for directing that fluid into a second bodily cavity while avoiding risks of infection and, in one embodiment, excessive dehydration of the first bodily cavity. The device includes an uptake tube having a proximal end in fluid communication with the first bodily cavity and a distal end in fluid communication with a pump, and an outflow tube having a proximal end in fluid communication with the pump and a distal end in fluid communication with the second bodily cavity. The distal end of the uptake tube may be coupled to a reservoir configured to expand upon ingression of fluid into the reservoir and to contract upon removal of fluid due to a negative pressure provided by the pump.

Abstract: The invention provides a system and a method for removal of contrast from blood. In one aspect, the invention provides a catheter for removal of contrast from the veins that drain the cerebral circulation. In a second aspect, the invention provides a method for removing contrast from blood by contacting the blood with a sorbent.

Abstract: A needle assembly comprises a metal needle (1) with a hub (13) and a marker in the form of a bubble-filled plastics rod (2) inserted within the needle. The rod (2) makes the assembly more visible under ultrasound observation when confirming correct placement of the needle (1) and is subsequently removed when correct placement has been confirmed.