Abstract: A disposable, absorbent “moisture management” drain pad for use on IV sites, tracheotomy tube sites, chest tube sites, catheter sites, g-tube sites, and drain sites. The pads will protect drain sites/skin area around drain sites from exudates/drainage by absorbing large amounts of fluid and locking it into a super absorbent core that remains dry on the outer surface next to the skin/drain site. The drain pad will contain an ultra-thin core containing super absorbent polymer and two layers of tissue substrates, a water impervious hydrophobic non-woven back sheet and a water pervious (hydrophilic) non-woven top sheet. Various materials can be substituted for these listed as long as they perform the required criteria need for the material.

Abstract: Devices, systems and methods are disclosed for providing a direct visual indication of the relative inflationary condition of the balloon on a balloon catheter after insertion into the patient. In certain exemplary embodiments, a gastrostomy tube catheter is disclosed having a fluid feeding lumen and a balloon inflation lumen, a balloon communicating with the balloon inflation lumen, and an indicator strip having one end fixedly attached to the balloon and a free end movable along the length of the tube in accordance with the relative inflation and deflation of the balloon. The presence of the free end of the strip along an exposed portion of the gastrostomy tube serves as a direct visual indicator of a deflated condition of the balloon.

Abstract: An electrochemical sensor includes a base plate including one end portion and another end portion, an electrode portion formed on the one end portion of the base plate, a connecting portion, formed on the another end portion of the base plate, for electrically connecting the electrode portion to a monitoring instrument, and an attaching portion formed on the another end portion, the attached portion being employed for attaching the another end portion to the monitoring instrument in a state where the one end portion is enabled to swing relatively to the monitoring instrument.

Abstract: A gastric nasal tube support system designed to hold various medical tubes that enter through a user's nose without the use of adhesive tape includes a pair of eye goggles that are held around the rear of a user's head with an elastic strap. A front portion of the goggles includes a clip structure spanning both sides of the nose area. The clip structure can hold various medical tubes such as gastric nasal tubes, oxygen tubes, drainage tubes, feeding tubes, or the like so that they remain in place as they enter the nasal cavity. The clip structure facilitates quick removal and replacement of tubes.

Abstract: An apparatus for guiding the placement of a subcutaneous device that includes a strap having an indentation configured for a fold of skin and fat layer to be positioned within the indentation as the subcutaneous device is advanced to a desired implantation site.

Abstract: A low-profile reduced pressure treatment apparatus and system are provided. The apparatus includes a moldable conduit holder, a conduit through the conduit holder, and a flexible base. The conduit holder has first and second bulkhead surfaces, a convex top surface, and a bottom surface adapted to conform to a tissue contact region adjacent to a tissue site. An end of the conduit is substantially flush with the first bulkhead surface and a longitudinal axis of the conduit is substantially perpendicular to the first and second bulkhead surfaces. The base is connected on a first side to the bottom surface of the conduit holder, and extends beyond the first bulkhead surface to form an overlay zone adjacent the first bulkhead surface. An adhesive is disposed on a second side of the flexible base to secure the flexible base to the tissue contact region.

Abstract: A securement device (10) secures a medical article (12) to the body of a patient and prevents longitudinal movement of the medical article (12) relative to the securement device (10). The securement device (10) includes a base portion (50) that is disposed over at least a part of a securement piece (20). The securement piece (20) forms a channel (19) configured to receive at least a portion of the medical article (12). The device (10) includes at least one actuator (40). The at least one actuator (40) is coupled with the securement piece (20) and configured to move the securement piece (20) between open position and a closed position. When the securement piece (20) is in the open position, it can receive at least a portion of the medical article (12). When the securement piece (20) is in the closed position, it prevents the received medical article (12) from moving in the longitudinal direction relative to the securement device (10).

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 universal device for securing a catheter on a patient includes a base which optionally has one or more locating elements for positioning or securing a catheter or catheter fitting of various shapes or sizes. The base optionally includes a recessed or flat receiving area defined by locating elements arranged to hold or receive a catheter or catheter fitting. Additional locating elements may be positioned elsewhere for receiving or holding a flange or wing of a catheter fitting. A cover is removably or permanently connected to the base and may optionally have one or more top openings for receiving tabs or extensions of a catheter fitting. The cover may optionally include one or more capture ridges for restraining a catheter or catheter fitting of various shapes or sizes on the base or on the retention plate. The cover may also include one or more tabs or contact bars.

Abstract: The present embodiments provide a surgical access port comprising at least one channel having proximal and distal ends, and a lumen extending therebetween. The at least one channel comprises a first state in which the proximal end is positioned proximal to the distal end, and comprises a second state in which the at least one channel is everted by advancing the proximal end through the distal end, such that the proximal end is positioned distally beyond the distal end. An expansion member of the surgical access port is configured for insertion through a surgical incision in a contracted state, and expands to a diameter larger than the surgical incision in an expanded state. In one embodiment, the expansion member comprises a toroidal balloon that comprises a material adapted to flex and conform to tissue distal to the surgical incision in the expanded state.

Abstract: A catheter holder which is compact and which can be relatively easily released while holding the unhoused portion of the catheter stably includes: an attachment portion for receiving or being attached to a portion of a holding tube housing a portion of the catheter, and a plurality of hold portions integral with the attachment portion and holding an unhoused portion of the catheter, which is exposed outside the holder tube.

Abstract: A tube unit for the enteral feeding of a patient, with a tube segment that extends along at least a segment of the axial direction (S), and a retention device on the distal end of the tube segment, which extends in at least one direction radially to axial direction (S) beyond the distal end of the tube segment in an extended position and which has a smaller diameter in an elongated position, in which the retention device is elongated along axial direction (S). The retention device moves from an extended position into the elongated position is supported by a control device.

Abstract: An anchor deployment apparatus for deploying an anchor about a therapy delivery element includes an anchor receiving element having an elongate member having a lumen. The lumen is configured to slidably receive at least a portion of a therapy delivery element. The anchor deployment tool further includes an anchor engagement element having (i) a body forming a channel in which the elongate member of the anchor receiving element is axially movable, and (ii) an engagement feature forming at least a part of the channel. The engagement feature is configured to engage the anchor when the anchor is disposed about the elongate member and the elongate member is moved relative to the engagement element, and to cause the anchor to move distally along the elongate member when the feature is engaged with the anchor and the elongate member is moved relative to the engagement element.

Abstract: An enteral feeding device having an improved base adapted to be deployed outside the human body and a tube which is adapted to be deployed within a lumen or cavity of the body by insertion through a stoma from outside the body is disclosed. The base of the device has a recess directly surrounding at least a portion of the proximal end of the tube to permit increase air flow and minimize contact with the tissue immediately surrounding the stoma to facilitate tissue wellness and reduce patient side effects due to moisture build-up, skin irritation and granulation of the stoma tissue.

Abstract: A device and method for placing jejunal tube device through stomach and into small intestine with spring mechanism that is curled to diameter that is similar small bowel diameter, wherein the spring mechanism can be straightened during placement with a stiffening apparatus. The stiffening apparatus is guided by a forceps, and includes a retractable wire for use in attachment to the forceps. A c-plug is provided for centering jejunal tube during the placement procedure and to facilitate insufflation, the c-plug being split about midline to facilitate removal of the c-plug after tube placement.

Abstract: A fixator assembly comprising a fixator for fixing inside a blood vessel, a guide tube attached to the fixator and a pump for supplying a liquid to the blood vessel or from the blood vessel via the guide tube. Blood flow past the fixator is possible during pumping so that critical situations are avoided. A method of providing a liquid to a blood vessel using the assembly is also claimed. Sampling or liquid dosing thus may be performed during extended periods of time while performing this at a well-defined position in the blood vessel and potentially close to or at the desired position in the person.

Abstract: A surgical portal assembly provides access to underlying tissue. The surgical portal has a seal which includes a gel layer and a fabric layer. The seal includes internal surfaces defining a passage for reception and passage of a surgical object in substantial sealed relation therewith.

Abstract: The present invention relates to a catheter securement device and securement device assembly for a securing a catheter relative to a patient. The securement device includes a base having an opening configured for receipt of the catheter, a cover member configured with the base over the opening, and a lip configured around at least a portion of the base. The base is configured for attachment to a patient's skin over a catheter insertion site and includes a top surface and a bottom surface. The opening of the base is configured to accommodate a catheter inserted therethrough from the catheter insertion site. The cover member is movable from an open position to a closed position over the catheter insertion site and is configured to secure the catheter. The lip is configured on the bottom surface of the base around the opening such that the lip reduces leakage from the catheter insertion site when the securement device is secured to the patient's skin.

Abstract: A securement system (100) includes a device which permits a portion of a catheter or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suture. A securement system for an elongated medical article comprises an anchor pad (110) and a retainer (120) mounted upon the anchor pad. The retainer (120) includes a channel (130) that has at least one abutment surface (160) corresponding to a contact surface on the medical article and a groove (210) configured to receive a spline (40) of the medical article. The medical article is placed into the channel (130). The medical article is secured within the channel by retaining at least one spline (40) and contact surface on the medical article.

Abstract: An outer ear bone anchor to be stabilized within a person's external auditory canal includes: a body; and a plurality of anchor pins, each of the anchor pins including a first end and a second end such that, when the first end of each of the anchor pins is secured to the external auditory canal, the second end of each of the plurality of anchor pins stabilize the body within the external auditory canal. A method of delivering medication to a person's middle ear or inner ear, the method comprising the steps of: securing an outer ear bone anchor in the person's external auditory canal; securing an inner catheter to the outer ear bone anchor, the inner catheter extending to the person's middle ear or inner ear; and passing medication through inner catheter to the person's middle ear or inner ear.

Abstract: A therapeutic agent injection device and body with a single piece body for an injection device including a planar deck having a patient face, the planar deck having cutouts around and through the planar deck, the planar deck including a delivery tube port on the patient face; a port segment attached opposite the patient face of the planar deck, the port segment including an introducer port including an introducer channel and an injection port including an injection channel the introducer channel being in fluid communication with the injection channel and the delivery tube port; and attachment projections protruding from the patient face.

Abstract: Improvements in an easily wearable catheter. A housing secures the components of the catheter, i.e. the valve, the removable cap, the twist valve, and the hose, to the user by means of an attachment. The present retainer for a peritoneal dialysis catheter relates generally to continuous ambulatory peritoneal dialysis methods and systems and, more particularly, to a user-wearable catheter housing which does not require any tape, belt or other bulky retainer to keep the catheter attached to the user.

Abstract: An anchor deployment apparatus for deploying an anchor about a therapy delivery element, such as a lead or a catheter, includes an anchor receiving element having an elongate member defining a lumen. The lumen is configured to slidably receive at least a portion of the therapy delivery element. The anchor is disposable about the elongate member. The deployment apparatus further includes an anchor engagement apparatus having an anchor engagement feature and a channel in which the elongate member of the anchor receiving element is moveable. The engagement feature is configured to engage the anchor when the anchor is disposed about the elongate member, and to cause the anchor to move distally along the elongate member when the feature is engaged with the anchor and the elongate member is moved proximally relative to the engagement element.

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 without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

Abstract: A retainer comprises a first member and a second member. The first member can define at least a portion of a channel. The channel can have a longitudinal axis and be configured to receive at least a portion of a medical article. The second member can be moveable with respect to the first member, between locked and unlocked positions. The second member can contact the portion of the medical article received by the channel at least when in the locked position so as to inhibit longitudinal movement of the medical article relative to the retainer.

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 pressure solution of an infusion solution holder has a collar that is ergonomically fitted to the shape of the shoulders. The collar includes a pressure tank integrally with the holder and a tank containing the infusion solution. Since the tank containing the infusion solution is located on the patient's shoulders and the vertically close to the supply point of the infusion solution, there has to be sufficient pressure in the tank in order for a successful infusion. Therefore, the collar's pressure tank is pressurized by the element, whereby the pressure in the pressure tank is pressing the solution tank and creates the necessary pressure at the time of infusion. The pressurization of the pressure tank is shown in the most cost-effective way by pumping with a manual pressure element, such as a ball pump. Pressurization can also be made, for example, by an electric pump.

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: Methods and devices for performing percutaneous and surgical interventions. The devices comprising a tubular portion and retractable mechanism at the distal end of the tubular portion. The retractable mechanism prevents the device from pulling out of an anatomical structure during complex interventions, for example, when switching from an antegrade to a retrograde approach within a blood vessel, enables the use of a single sheath when declotting AV hemodialysis fistulas and can provide occlusion of blood flow during interventions and means of removal of debris or clot from the blood vessel.

Abstract: A catheter connector and securement device system includes a connector seated within a securement device. The securement device includes a lower shell member having a perimeter wall defining an interior cradle space that conforms to the connector body. A cover member is hinged to the lower shell member at a hinge line and is movable from an open position for insertion and removal of the connector to a closed position wherein the cover member releasably latches to the lower shell member to retain the connector within the lower shell member. A catheter retention device may be spaced from the perimeter wall.

Abstract: An electronic injector including an electronic on-body injector for use with a patient to deliver a fluid through an injection device. The electronic on-body injector includes a fluid reservoir; a MEMS pump; a bolus injection needle, the bolus injection needle having a bolus injection needle tip aligned with the injection port, the bolus injection needle being slideably biased away from the injection port to define a gap; and a bolus needle button operably connected to the bolus injection needle to slide the bolus injection needle along the injection axis. The bolus needle button is operable to advance the bolus injection needle tip to close the gap and advance the bolus injection needle tip into the injection port to form a bolus injection flow path. The bolus needle button is further operable to activate the MEMS pump to deliver a predetermined bolus volume.

Abstract: A catheter strain relief clip includes a body having an upper surface, and a plurality of arm members extending upwardly from the upper surface. Each of the arm members defines an undercut region for receipt of a catheter. The arm members are disposed so as to define a bent path for a catheter threaded under each of the arm members from a first side to an opposite side of the body.

Abstract: A catheter securement device includes a flexible base member having an adhesive side and an opposite non-adhesive side. A elastomeric anchoring member is mounted on the nonadhesive side of the base member. The anchoring member integrally includes a body attached to the base member, a pair of opposing pull tabs freely extending outwardly from the body, a keeper disposed in each of the pull tabs, and a T-shaped strap freely extending from the body.] The T-shaped strap terminates in a pair of opposing heads that are disposed generally parallel to the pull tabs. Pulling the opposing pull tabs opens the keepers for receiving the heads of the T-shaped strap, and the heads of the T-strap are selectively insertable into the keepers for securing a catheter between the anchoring member body and the strap.

Abstract: A laparoscopic port assembly includes a cannula unit including three cannulas each extending at an acute angle relative to a base. The cannulas are flexible for receiving respective angulated laparoscopic instruments. The cannula unit is rotatingly received in a port holder for rotation about a longitudinal axis of the holder, the holder being disposable in an opening in a patient's skin.

Abstract: An integrated vascular delivery system having a frame configured to receive a catheter insertable in a patient to deliver fluid at an insertion site. The frame includes a first hub, a second hub, and a pair of flexible lateral members extending between the hubs and including a tubular lateral member. The system also includes a fluidic channel that fluidically communicates with the catheter, wherein the fluidic channel passes through the tubular lateral member and at least one of the hubs, and includes a fixed turnabout portion in which fluid flows in a direction different from that within the catheter. The first and second hubs provide anchoring points on the patient distributed around the insertion site and on opposite ends of the catheter, thereby anchoring the frame to the patient and stabilizing the catheter. A method is provided for using an integrated vascular delivery system.

Abstract: The invention relates to an antimicrobial dressing, an anti-microbial composition and use thereof. The dressing comprises: chlorhexidine and/or a pharmaceutically acceptable salt thereof in a solid state in a quantity, calculated as an equivalent weight of chlorhexidine digluconate/surface of dressing, comprised between 0.013 and 2 g/m2; and silver and/or a pharmaceutically-acceptable salt in the solid state in a quantity, calculated as an equivalent weight of metallic silver/surface of dressing of greater than or equal to 0.1 g/m2. The composition comprises: chlorhexidine and/or a pharmaceutically acceptable salt thereof in a solid state in a relative weight/weight percentage, calculated as an equivalent weight of chlorhexidine digluconate/total weight of the composition, comprised between 0.01% and 0.09%; and silver and/or a pharmaceutically acceptable salt thereof in the solid state in a relative percentage weight/weight comprised between 0.00008% and 0.

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: An apparatus for direct gastric feeding via a gastrostomy tract formed in a patient. The apparatus includes a tube, an internal bolster, an external bolster, and a force-generating device. The force-generating device may include a pair of automatically adjustable spring members on the external bolster. The spring members are responsive to changes in the length of the gastrostomy tract and eliminate the need for periodic adjustment or replacement of the apparatus.

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: Exemplary systems for loading a pre-curved electrode array onto a stylet include a loading tool and a stylet retainer. The loading tool includes a docking assembly comprising a plurality of wing members that form a receptacle configured to receive a proximal portion of the stylet, a channel assembly comprising a channel configured to receive and allow passage therethrough of the pre-curved electrode array, the channel further configured to receive a distal portion of the stylet, and a connecting member configured to connect the channel assembly to the docking assembly. The stylet retainer is configured to couple to the loading tool to retain the stylet within the loading tool while the pre-curved electrode array is loaded onto the stylet. Corresponding methods are also described.

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 without the use of sutures or skin tapes. In particular embodiments, the anchor device can be adjusted to a folded condition so that subcutaneous anchors are partially rotated prior to removal from the skin penetration point.

Abstract: Some embodiments of a medical system include a subcutaneous anchor device that extends outwardly from side wall of an intravenous cannula so as to secure the intravenous cannula in a position relative to a skin penetration point.

Abstract: A transcutaneous implantable access port for removal and/or return of fluids of a patient comprises a fixation unit adapted to be fixed to a bone of the patient; a valve unit comprising a sealing membrane at its distal end and one or more chambers; an internal conduit fluidly connectable to vascular structure of the patient and releasably connectable to the valve unit to establish fluidic communication between the internal conduit and said one or more chambers; and an extracorporeal connecting member having an end portion. The extracorporeal connecting member is connectable to the distal end of the valve unit, opening and closing a fluidic passage between the connecting member and said one or several chambers when the connecting member is respectively connected to the access port and withdrawn therefrom. The access port can be used for high volume removal and/or return of blood or other fluids from the patient.

Abstract: An intravenous catheter securement device to secure an IV cannula, IV tubing, and attachments in place and to reduce the need for adhesive tape application, including a protective dressing body that secures an intravenous catheter between a cover flap and a lower portion thereof; a continuous pocket disposed between cover flap and the lower portion inner sides for securing a splint for immobilizing an IV site with minimal interference of the dressing body; an opening centrally disposed on the lower portion that serves as a viewing port over an IV site; a vertical slit centrally disposed on the lower portion between the front side and the opening that permits the dressing body to pass either side of a cannula and IV tube; and various attachment strips and tabs that secure an IV line to prevent kinking thereof and to prevent the IV line from weighing down on the cannula.

Abstract: The present disclosure generally provides systems and methods of anchoring surgical wires, catheters, leads, and other medical objects in an effective, efficient, and cost-sensitive manner. In one embodiment, the present disclosure could include a system to secure a medical object. The system could include a body having a first inner arm, a second inner arm, and a first outer arm. The first inner arm and the first outer arm could include a pronged structure. The system could also include a crossbar having a bore to receive a screw. The crossbar could be disposed between opposing surfaces of the first inner arm and the second inner arm and could be coupled to sliding grooves disposed along the opposing surfaces. When the screw is in an engaged position relative to the crossbar, the pronged structure could be configured to secure the medical object.

Abstract: Methods and apparatus for anchoring a catheter to a patient's skin using a catheter anchoring device are described. The catheter anchoring device includes one or more pairs of sharps with a sharpened end configured to pierce the surface of the skin. A locking mechanism for the sharps is used as a failsafe mechanism. The catheter anchoring device further includes a catheter clamp for securing a catheter to the catheter anchoring device. Releasing the clamp allows an operator to reposition and secure the catheter at the new position without moving the catheter anchoring device.

Abstract: An infusion set for use with a fluid infusion device is provided. The infusion set can include a mount including a projection having a bore. The projection can be surrounded at least partially by a recess defined through a surface of the mount, and the mount can include at least one rib that spans the recess. The infusion set can include a fluid outlet coupled to at least a portion of the bore of the projection and a coupling device to couple the infusion set to a user. The coupling device can be coupled to the surface and the at least one rib of the mount.

Abstract: Some embodiments of a medical device anchor system includes an anchor sleeve and a catheter (or other medical instrument) to advance though a working channel of the anchor sleeve. The anchor sleeve may have a subcutaneous cuff device arranged along an outer surface. In such circumstances, the embedded cuff device can inhibit the migration of infection from outside the skin and into the blood stream.

Abstract: Exemplary loading tools configured to facilitate loading of a pre-curved electrode array onto a stylet include a docking assembly, a channel assembly, and a connecting member configured to connect the channel assembly to the docking assembly and maintain a distance therebetween. The docking assembly is configured to couple to the stylet. The channel assembly includes a channel configured to receive and allow passage therethrough of the pre-curved electrode array. The channel is aligned with the docking assembly such that when the stylet is coupled to the docking assembly, the stylet is located at least partially within the channel.

Abstract: An intravenous catheter anchoring assembly is disclosed and includes a patient-contacting membrane, a platform, and a retaining strap for securing a catheter or tubing of an administration set to a patient. The strap is attached to the platform with adjustable pull-tabs that permit a variety of catheter shapes and sizes to be secured. The strap is also elastomeric so that the strap is stretchable and thereby grabs the secured catheter. The strap and platform further define a plurality of passageways that permit the catheter to be secured in a plurality of non-aligned directions.