Abstract: A method for implanting a wireless neural stimulator device, the method including: inserting a device through on a patient's skin on a posterior side of the patient's neck region, wherein the device includes a proximal end, a distal end, a first opening at the proximal end, a second opening at the distal end, and a lumen extending between the first opening and the second opening; after inserting the device through the patient's skin, advancing the distal end into the epidural space of the patient; inserting the wireless neural stimulator device through the first opening; advancing the wireless neural stimulator from the first opening through the lumen until the wireless neural stimulator exits the second opening and into the patient's epidural space; and advancing the wireless neural stimulator through the epidural space until a target site is reached.

Abstract: Systems, methods, and apparatuses are presented that facilitate the provision of reduced pressure to a tissue site by using a delivery-and-fluid-storage bridge, which separates liquids and gases and provides a flow path for reduced pressure. In one instance, a delivery-and-fluid-storage bridge includes a delivery manifold for delivering reduced pressure to a treatment manifold at the tissue site and an absorbent layer proximate the delivery manifold adapted to receive and absorb liquids. The delivery manifold and the absorbent layer are encapsulated in an encapsulating pouch. A first aperture is formed proximate a first longitudinal end of the delivery-and-fluid-storage bridge for fluidly communicating reduced pressure to the delivery manifold from a reduced-pressure source, and a second aperture is formed on a patient-facing side of the delivery-and-fluid-storage bridge. Reduced pressure is transferred to the tissue site via the second aperture. Other systems, apparatuses, and methods are disclosed.

Abstract: The invention relates to devices, methods and systems for collecting and solidifying waste material from bioreactor cell cultures in order to facilitate waste disposal. The invention finds particular utility in mammalian cell culture applications. A transverse wall divides the interior of a waste bag into two chambers, the first chamber containing an inlet receiving waste liquid from a bioreactor, the second chamber containing an absorbent material to solidify the liquid into a gel. The transverse wall acts to direct the flow of waste media into the second chamber where it is converted into a gel and further prevents the inlet from being blocked by any gel or particulate materials. Methods and uses regarding this invention are described.

Abstract: An infusion set preferably for use with an inserter is disclosed. The infusion set includes a septum cap that encapsulates an upper resilient septum and a lower resilient septum of a base, and includes at least one radial port to receive insertion of a blunt cannula when an extension set hub is engaged with the infusion set in a direction substantially parallel to the skin surface. The extension set hub is configured to provide a snap-fit engagement with the septum cap, wherein the blunt cannula of the extension set hub is guided through the radial port of the septum cap and penetrates the interface between the upper septum and the lower septum. The extension set hub and the septum cap can be rotated in a 360 degree manner about the base of the infusion set.

Abstract: A fluid flow conduit assembly includes a flexible conduit having a closed cross section, and a connector. The connector has first and second layers with the flexible conduit extending between the first and second layers, and wherein the first and second layers are permanently attached to each other outside of the flexible conduit.

Abstract: A medical device for delivery of a fluid to a patient from a line terminating in a tubing needle. The medical device includes a cannula assembly for coupling the fluid into a cannula that is inserted into the patient. The cannula assembly has a first locking element disposed in a fixed position with respect to the cannula. Coupling the line to the cannula assembly is an infusion flap. The infusion flap includes a second locking element for engaging the first locking element of the cannula assembly and a lift tab for disconnecting the infusion flap from the cannula assembly. Coupling of the first and second locking elements requires initial mating of the infusion flap and cannula assembly followed by locking through rotation of the infusion flap with respect to the cannula assembly.

Abstract: Systems, methods, and apparatuses are presented that facilitate the provision of reduced pressure to a tissue site by using a delivery-and-fluid-storage bridge, which separates liquids and gases and provides a flow path for reduced pressure. In one instance, a delivery-and-fluid-storage bridge includes a delivery manifold for delivering reduced pressure to a treatment manifold at the tissue site and an absorbent layer proximate the delivery manifold adapted to receive and absorb liquids. The delivery manifold and the absorbent layer are encapsulated in an encapsulating pouch. A first aperture is formed proximate a first longitudinal end of the delivery-and-fluid-storage bridge for fluidly communicating reduced pressure to the delivery manifold from a reduced-pressure source, and a second aperture is formed on a patient-facing side of the delivery-and-fluid-storage bridge. Reduced pressure is transferred to the tissue site via the second aperture. Other systems, apparatuses, and methods are disclosed.

Abstract: Systems, methods, and apparatuses are presented that facilitate the provision of reduced pressure to a tissue site by using a delivery-and-fluid-storage bridge, which separates liquids and gases and provides a flow path for reduced pressure. In one instance, a delivery-and-fluid-storage bridge includes a delivery manifold for delivering reduced pressure to a treatment manifold at the tissue site and an absorbent layer proximate the delivery manifold adapted to receive and absorb liquids. The delivery manifold and the absorbent layer are encapsulated in an encapsulating pouch. A first aperture is formed proximate a first longitudinal end of the delivery-and-fluid-storage bridge for fluidly communicating reduced pressure to the delivery manifold from a reduced-pressure source, and a second aperture is formed on a patient-facing side of the delivery-and-fluid-storage bridge. Reduced pressure is transferred to the tissue site via the second aperture. Other systems, apparatuses, and methods are disclosed.

Abstract: A system for delivering a fluid to a Eustachian tube (ET) of a patient includes a guide member and a tubular member. The guide member includes a shaft having a proximal portion, a distal portion, and a bend at the distal portion. The bend is configured to provide access to an opening in the ET. The system further includes a tubular member comprising a proximal end, a distal end, and a lumen extending therebetween. The tubular member is sized to fit within the ET. One or both of the tubular member and the guide member comprises a first stop member configured to engage the other of the tubular member or the guide member. The first stop member is configured to restrict a distal advancement of the tubular member relative to the guide member.

Abstract: A medical timing device and method have, in an embodiment, a timer configured to be activated so as to indicate the in-use time of a medical article. The medical timing device is configured to have a lock condition and a timer activation condition. In an embodiment, the medical timing device is operable to cause both the lock condition and the activation condition to occur in response to a single action.

Abstract: The present invention relates to a device that secures a straight or Foley catheter in the urinary tract of a male subject. The device includes a portion that can be coupled to the subject's penis and a portion that can be coupled to the straight or Foley catheter. The present invention also relates to methods of making and using this device and to assemblies including the device and a straight or Foley catheter.

Abstract: Strain relief loop holders maintain the strain relief loop formed in a lead while also addressing the excessive heating at the point in the loop where the medical lead intersects with itself. The strain relief loop includes a body section that the medical lead passes through where the intersection occurs. The body section may be a thermal non-conductor and isolate from excessive heating at the intersection point or may be a thermal conductor and distribute the excessive heating. The strain relief loop may include features such as arms or a coil extending from the body segment with arm segments at the ends of the arms defining lead passageways that assist in maintaining the strain relief loop. The body segment may have a single lead passageway where the intersection point occurs or may have multiple lead passageways. The body itself may house the loop by forming a loop or a capsule.

Abstract: Percutaneous access apparatus is described that includes a percutaneous fluid access device having an extracorporeal portion, one or more ports accessible from the extracorporeal portion and a septum for sealing each port. A connector device having one or more hollow needles is attachable to the percutaneous fluid access device. The apparatus also includes an attachment mechanism for attaching the connector device to the extracorporeal portion and an actuation mechanism that, after the connector device has been attached to the extracorporeal portion, can be used to drive the one or more hollow needles through the septum to establish fluid communication between the one or more hollow needles and the one or more ports. The apparatus may be used for neurosurgery applications.

Abstract: A Safety Huber needle assembly comprising a needle used to pierce the septum of an implanted venous port, a baseplate that rests against the insertion site and a pivotally displaceable housing that acts to remove the needle from the septum of the implanted port and to effectively enclose the needle to provide user safety when the housing is displaced to a needle securing state.

Abstract: Various embodiments may include methods of manufacture of a retrofitted neural injection system. Various embodiments may include acquiring an injection needle comprising a hollow cannula with an open distal end. Then, forming at least one side port in the hollow cannula proximate to the distal end. Then, sealing the open distal end of the hollow cannula with a biocompatible sealant so as to eliminate fluid communication between an inside and an outside of the hollow cannula via the distal end. In some embodiments, the biocompatible sealant may be comprised of a thermosetting material. In some embodiments, the biocompatible sealant may be comprised of a cured epoxy resin. In some embodiments, the biocompatible sealant may be comprised of an aliphatic polymer. In some embodiments, the biocompatible sealant may be comprised of a polyfluorocarbon.

Abstract: An implant device having a proximal end and a distal end, and a suturing fixture offset from the proximal end. The suturing fixture has a profile that extends from the surface of the elongate body. For example, the suturing fixture may have the shape of a cone, or the shape of a disc. The implant device may be used for placement within a salivary gland duct.

Abstract: A securement system for anchoring a medical article to a patient includes a pliant holding device. The device has a body and a plurality of tentacles extending from the body. The tentacles compress and may conform around at least a portion of the medical article to form a secure mount. The holding device may also cushion the medical article and protect the site of attachment on the patient while promoting air circulation. The holding device may include a support and a hinge so that the holding device may be swung away from the medical article to provide easy access for a medical provider.

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin penetration point without the use of sutures or skin tapes.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter) in place relative to a skin penetration point using subcutaneous anchors.

Abstract: A device for supporting a surgical line, such as a surgical drain, a catheter or the like, is provided, the device comprising a base having an opening therein for receiving a first line extending from a subject; and a connector mounted to the base and having a first end for connection to an end of the surgical line and a second end for connection to a second line. The device preferably comprises a housing mounted to the base and enclosing the opening in the base, with the connector extending through the housing. The housing or a portion thereof is removable to provide access to the interior of the housing. The housing or a portion thereof is preferably rotatable with respect to the base.

Abstract: An endoscopic microinstrument may include a substantially rigid body having first and second ends, a channel between the first and second ends; a substantially rigid end portion movably coupled to the body and having first and second ends; a tool located at the first end of the end portion and including first and second anvils; first and second handles coupled to the body, at least one of the handles further coupled to the tool and configured to control actuation of at least one of the first and second anvils; a camera coupled to, and situated to a side of, the substantially rigid end portion, the camera configured to obtain images of a region-of-interest; and an end portion controller coupled to the body and configured angulate and/or rotate the substantially rigid end portion relative to the substantially rigid body.

Abstract: A self-injection device with a miniaturized drug delivery portion is provided. The device includes a housing (10) having an interior volume and the drug delivery portion (20) has a volume enclosed within the housing. The drug delivery portion includes a reservoir (30) containing a fluid to be delivered to a user and a microneedle (22) in fluid communication with the reservoir and extendable through the housing. The drug delivery portion also includes a drive mechanism for expelling fluid from the reservoir through the microneedle, wherein the volume of the drug delivery portion is less than 40% of the interior volume of the housing. The volume of the drug delivery portion may be less than 30% of the interior volume of the housing.

Abstract: In one form, a direction changing device is provided including: a first mounting section; and a second mounting section, wherein an axial direction of the first mounting section and an axial direction of the second mounting section intersect each other or are parallel to each other in plan view, and in a condition where a catheter or a sheath introducer in which the catheter is inserted is mounted to the first mounting section and the second mounting section, the catheter or the sheath introducer adopts a curved shape such that a catheter or sheath introducer portion mounted to the first mounting section extends proximally to distally in one direction and a catheter or sheath introducer portion mounted to the second mounting section extends proximally to distally in another direction with the directions being different from each other.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host.

Abstract: A barrier system is provided for use in reducing infections associated with a percutaneous medical device, such as a catheter, that is disposed within a percutaneous incision. Such a barrier system can include: a barrier device having a skin-contacting surface and a catheter-receiving surface; and an adhesive composition configured for adhering to skin, the barrier device, and/or the catheter so as to form a barrier at or adjacent to an incision in the skin where the catheter is percutaneously inserted through the skin. The barrier device can include a conduit configured to receive the catheter. Alternatively, the barrier device can include a groove in a base surface that is configured to receive the catheter. A system that includes a medical device, the barrier device, and adhesive can also be provided.

Abstract: A portal access device has a first member pivotally movable relative to a base. A groove is provided at the first member to be in alignment with a bore at the base, so that a cannula may freely extend through the bore, with a portion of the cannula being frictionally held along the groove of the first member. The first member may be rotatably connected to a second member, so that once the cannula is correctly inserted into a portal, the first member may be pivoted from its vertical position to its horizontal position to bend the cannula into a right angle cannula. The cannula is removed from the portal by pivoting the second member upwardly away from the base. In an alternate portal access device where there is only one arm member, the portal access device may be removed from the portal by being pulled vertically upwards.

Abstract: A skull mountable, implantable percutaneous fluid delivery device is described for use in delivering fluids to target sites in the brain. The device includes a subcutaneous base portion including one or more ports for supplying fluid to one or more implanted catheter devices. A percutaneous portion of the device includes an extracorporeal surface, the one or more ports of the subcutaneous base portion being 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 and includes one or more anchoring features including at least one radially protruding wing for directly anchoring the subcutaneous base portion to the bone.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the anchor device can be installed using a technique in which the subcutaneous anchors undergo relatively little or no flexing when being inserted through the skin into the subcutaneous region between the skin and underlying muscle tissue which may be occupied by fatty tissue.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the medical instrument can be coupled to the anchor device using a snap-lock cap mechanism.

Abstract: We have disclosed dressing devices that combine the functions of coverage of a catheter insertion site, fluid handling capacity for the puncture site of a catheter, and fixation of the catheter. More specifically, we have disclosed dressing devices comprising a base, a pad, and a dressing film, and the devices possess antimicrobial properties. We further disclose a method of making the disclosed dressing devices, a kit comprising the disclosed dressing devices and a catheter fastener means, a method of installing the dressing devices on a patient's skin over an indwelling catheter, and a method of replacing the disclosed dressing devices.

Abstract: A percutaneous ostomy implant for implantation into the abdominal wall of a patient is provided, which includes a connecting member for mounting an external detachable device thereto; a first tubular ingrowth member depending from the connecting member; and a second tubular ingrowth member depending from the connecting member and being radially outwardly spaced from the first tubular ingrowth member. The first tubular ingrowth member is configured and dimensioned to receive a bowel segment within it to allow the stoma and serosal tissue of that bowel segment to infiltrate the first tubular ingrowth member. The second tubular member is configured and dimensioned to abut dermal tissue to allow the dermal tissue to infiltrate the second tubular ingrowth member, thereby securing and sealing the ostomy implant to the dermis.

Abstract: A surgical apparatus for positioning within a tissue tract accessing an underlying body cavity includes a seal anchor member including leading portion, a trailing portion, and an intermediate portion disposed between the leading and trailing portions. The leading portion of the seal anchor member is configured and adapted to ease insertion of the seal anchor member into the tissue tract. Subsequent to insertion of the seal anchor member, the leading portion of the seal anchor member is also configured and adapted to facilitate securing and/or anchoring of the seal anchor member within the tissue tract.

Abstract: A catheter securement device holds a medical article such as a catheter hub or a connector fitting in position upon the body of a patient and at least inhibits longitudinal movement of the medical article. The securement device includes a retainer and at least one anchor pad. The retainer forms a central channel into which at least a portion of the medical article is inserted. The retainer includes at least one abutment that can abut against a contact point or surface on the medical article. The abutment, in conjunction with a second abutment and/or a tapering shape of the central channel, inhibits motion of the medical article in proximal and distal directions through the central channel. For this purpose, the abutment surface(s) can lie either within or outside the channel.

Abstract: A method for manufacturing a structural part with a cannula for the subcutaneous administration of an active substance is disclosed. A loose cannula is threaded on a piercing means to form a ready-to-use cannula piercing unit and subsequently, a cannula housing is injection-molded onto the cannula. Embodiments for the cannula as well as the structural part, an application part, an insertion head, and an insertion device which includes the cannula are also disclosed.

Abstract: Catheter assemblies, kits and methods allowing for the drainage or administration of fluid or small particles are disclosed. A catheter assembly can include a shaft with a lumen, an expandable retention member, an elongate actuation member and a locking mechanism. The expandable retention member can be positioned at a shaft distal end portion and can include one or more filaments forming a plurality of drainage or administration interstices of variable or uniform size. The elongate actuation member can include an actuation member distal end, directly or indirectly engaged with the expandable retention member, and an actuation member proximal end. Movement of the actuation member proximal end relative to a proximal end of the shaft can cause the expandable retention member to change from a lower-profile configuration to a higher-profile configuration. A moved position of the elongate actuation member can be secured by rotating, sliding or otherwise manipulating the locking mechanism.

Abstract: The present invention provides a catheter clamp assembly having a base and a slide cover. The base has a top, bottom and a body including a slide cover track. The body has internal walls defining a catheter opening extending from the bottom to the top. A catheter channel extends from the catheter opening to a sidewall opening. The slide cover includes a lower surface incorporating a prong to engage a wall defining the catheter opening and to secure a catheter in the catheter channel. The slide cover has a first location providing access to the catheter opening and a second location that clamps a catheter in the catheter channel. Moving the slide cover from its first location contacts a length of catheter extending through the catheter opening to position it in the catheter channel for securement when the slide cover reaches its second location.

Abstract: A nasogastric tube includes a connector. The connector has a first connection end, a second connection end and a flow channel formed through the connector. The first connection end is connected to a first tube, and the second connection end has a positioning sleeve formed thereon. The positioning sleeve has a connection part extended from the flow channel and jointing with an assembling part of the second tube. The first tube of nasogastric tube of the present invention can be inserted to a stomach from a nasal cavity, and then the connector is placed in the nasal cavity, and the positioning sleeve is fixed in the nostril. The second tube can be detached from the connector when not being used.

Abstract: A securement device for retaining medical tubing, catheters, and other medical fixtures proximal a patient's skin. The device has a base, at least one channel formed in the base, a flexible strap for overlying the base, and a coupling assembly for coupling the strap to the base. Embodiments for use with Foley catheters include a plurality of channels of differing diameters. Embodiments for use with a peripheral catheter include a single channel for retaining a spin nut. The coupling assembly includes left and right tracks in left and right sides of the base, and left and right rails on an underside of the flexible strap at left and right ends of a body of the strap. The left rail is removably coupled and held within the left track on the base, and the right rail is removably coupled and held within the right track on the base.

Abstract: A system for treating a bone includes an insert for a bone screw or a fixation nail. The insert includes a shaft that extends between proximal and distal ends of the insert and a cap. The shaft includes an opening in the proximal end and a cannulation extending from the opening through at least a portion of the shaft. The shaft further includes a fenestration disposed along the cannulation such that the cannulation is configured to provide a pathway for a substance between the opening and the fenestration. The cap is fastened to and seals the opening in the proximal end of the shaft and adjoins the cannulation. The cap is configured to provide a needle access through the cap to the cannulation following implantation of the system within the bone, and is further configured to self-seal after the needle is removed.

Abstract: An anchor deployment assembly includes an anchor receiving element having an elongate member defining a first opening, a second opening, and a lumen extending from the first opening to the second opening. The lumen is configured to slidably receive at least a portion of a therapy delivery element. The assembly further includes an anchor engagement element having a body defining a channel configured to slidably receive the elongate member of the anchor receiving element. The assembly further includes an alignment element securable relative to the elongate member of the anchor receiving element and configured to secure the elongate member relative to the body of the anchor engagement element to restrict movement of the elongate member orthogonal to a longitudinal axis of the channel of the body.

Abstract: Some embodiments of a medical device anchor system include an anchor device that secures a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors. In some implementations, the medical instrument can be coupled to the anchor device using a snap-lock cap mechanism.

Abstract: The invention describes new synthetic medical adhesives and films which exploit the key components of natural marine mussel adhesive proteins.

Abstract: Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin penetration point without the use of sutures or skin tapes.

Abstract: An irrigation system for a surgical instrument includes an irrigation tube arranged to convey an irrigation fluid and an irrigation clip structurally arranged to receive a portion of the irrigation tube. The irrigation clip includes a proximal portion, a distal portion, a body portion, and an arm portion. The arm portion is structurally configured to selectively attach the irrigation clip to the surgical instrument and to bias the irrigation clip toward the surgical instrument with a biasing force. The irrigation clip includes a tube locking portion structurally arranged to cooperate with the surgical instrument to engage the outer surface portion of the irrigation tube to inhibit rotation and axial displacement of the irrigation tube relative to the irrigation clip in response to the biasing force.

Abstract: Some embodiments of a medical anchor device include an elongate body coupled with deployable subcutaneous anchors to secure a catheter instrument (or other medical instrument) in place relative to a skin penetration point. In some circumstances, the elongate body may be in the form of catheter hub body, and the subcutaneous anchors can be deployed from the hub body by adjustment of a movable actuator. A locking member can interact with the actuator so as to retain the actuator in the deployed orientation during the medical procedure.

Abstract: In collocated radios, interference is mitigated to permit concurrent radio operation. In response to detection of imminent transmission of interfering wireless (i.e., RF jammer) signals, gain settings of one or more stages of front-end receiver amplifiers may be quickly configured to permit concurrent frequency division operation instead of consecutive time-division operation. This expansion of concurrent operation may improve communication bandwidth and/or may produce reliable, consistent results. Gain control responsive to detection of imminent RF jamming may maintain amplification in a linear range where interference can be filtered out. Receiver gain may be shifted from a default high gain or high sensitivity setting to lower gain to maintain integrity of a signal of interest (SoI), which avoids clipping, distortion and unwanted products caused by a high power jamming signal that could otherwise make it impossible to recover the SoI.

Abstract: Ports for accessing 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: Medical devices, systems, and methods reduce the distance between two locations in tissue in a minimally invasive manner, often for treatment of congestive heart failure. In one embodiment, an anchor of an implant system may, when the implant system is fully deployed, reside within the right ventricle in engagement with the ventricular septum. A tension member may extend from that anchor through the septum and an exterior wall of the left ventricle to a second anchor disposed along an epicardial surface of the heart. Deployment of the anchor within the right ventricle may be performed by inserting a guidewire through the septal wall into the right ventricle. The anchor may be inserted into the right ventricle over the guidewire and through a lumen of a delivery catheter. Delivering the anchor over the guidewire may provide improved control in the delivery and placement of the anchor within the right ventricle.

Abstract: A Luer securement device comprising a flexible hood that is configured to attach to the surface of a patient, the flexible hood further having a Luer adapter for receiving a catheter inserter and/or a fluid line. The Luer securement device further includes a wedge seal that is positioned within the Luer adapter and is configured to receive a base portion of a catheter during a catheterization procedure. Once the base of the catheter is seated within the wedge seal, a proper insertion depth of the catheter into the patient is achieved.

Abstract: A universal device for securing a catheter on a patient includes a base which optionally has at least one locating element for positioning or securing a catheter or catheter fitting of various shapes or sizes. The base has an opening and one or more restraining elements positioned on a surface of the base and extending over a portion of the opening. A retention plate includes locating elements for positioning or securing a catheter or catheter fitting of various shapes or sizes on the retention plate. Optionally, the retention plate may be movable. A support plate or similar device attached to the base holds the retention plate between the restraining elements and the support plate. A cover is connected to the base and may optionally have at least one capture element for restraining a catheter or catheter fitting of various shapes or sizes on the base or on the retention plate.