Abstract: The disclosure relates to systems and methods for controlling the sodium and bicarbonate concentrations in a dialysate. The systems and methods can use conductivity sensors to control the addition of water and bicarbonate to accurately control the final concentrations of both sodium and bicarbonate.

Abstract: Securement arrangements for use in securing a patient interface to the skin of a patient include a substrate material having a first surface and an adhesive material disposed on the first surface. The locations of the adhesive material are varied so as to minimize repetitious adherence of the adhesive material to the patient during repeated applications.

Abstract: A tissue marking device enables the deployment of a hook to mark a location within a breast. The deployment is performed by inserting a needle in tissue until it arrives at a target location and pressing on the end of a rod that embeds the hook in the tissue. A thread is attached to the hook and is left exposed to facilitate locating the hook.

Abstract: A catheter housing device for securing a catheter and needle assembly to a patient. The device can include a cover, an IV/catheter lock, a hub, and one or more fastening straps. The device can replace conventional devices and techniques for securing a catheter and needle to a patient that utilize adhesive materials and/or methods, which are ill-equipped to solve complications including infection/contamination of the insertion site, irritation/damage to the vein or insertion site due to inappropriate angling of the catheter/needle, etc. The devices and methods disclosed herein can provide catheter/needle securement and optimal inclination, a hermetically sealed chamber to resist infection and/or contamination, inert gas or soothing anesthetic vapor drugs in and around the device, and various skin-contacting layers and structures that promote ventilation and patient comfort in and around the insertion site.

Abstract: Some embodiments of a medical device anchor system include an anchor device, a tether, and an adapter for securing a medical instrument (such as a catheter or the like) in place relative to a skin penetration point using subcutaneous anchors.

Abstract: The present teachings include techniques for securing a connection to a dialyzer or the like—e.g., securing the junction between a dialyzer port and a connector (e.g., a DIN connector) that couples the port to tubing of an extracorporeal circuit of a hemodialysis system. To this end, a locking device may engage both a DIN connector and a portion of the dialyzer, such as the cap or an adapter engaged therewith. The locking device may include an interior void sized and shaped to accommodate winged portions (or other portions) of the DIN connector to mitigate rotation thereof relative to the port to which it is engaged. Further, the locking device may be used to ensure that coupling between the DIN connector and the port is proper and secure. In this manner, a locking device can mitigate leaks, which can be catastrophic during a hemodialysis treatment or the like.

Abstract: A catheter securement device includes a body having a generally curved channel configured to receive a central venous catheter and reposition it in a different direction than the direction of the catheter as it exits the skin of the patient. The securement device includes a cover that slidably connects to the securement device body to prevent the catheter from being pulled out of the curved channel.

Abstract: An apparatus for fastening around a cranial burr hole includes a substantially flat core and a shell encapsulating a ring portion of the core. The shell defines an orifice substantially centered within the ring portion, and has a contoured lower surface to match the cranial curvature. Pliable arms of the core extend laterally from the ring portion, each being terminated by a fastener member. A central portion of a placement tool for the apparatus has a lower part configured to extend through the apparatus orifice, and an upper part from which first and second arms of the tool extend laterally. Each tool arm is terminated with a receptacle to hold a bone screw, and, when the tool central portion lower part extends through the apparatus orifice, each receptacle aligns with a corresponding fastener member, and lower openings of the receptacles are generally oriented along the contoured lower surface.

Abstract: A therapeutic illumination assembly includes a catheter and a point source treatment fiber. The catheter comprises a catheter wall encircling a luminal fluid pathway. The point source treatment fiber is positioned within the luminal fluid pathway of the catheter. Further, the point source treatment fiber comprises a plurality of light emitting point sources intermittently positioned along a treatment length of the point source treatment fiber such that the plurality of light emitting point sources irradiate the catheter when the plurality of light emitting point sources emit light.

Abstract: A catheter adapter may include a catheter adapter body and a catheter adapter channel formed within the catheter adapter body. The catheter adapter body may include a proximal end, a distal end, an inferior surface, and a superior surface. The inferior surface of the catheter adapter body may be configured to abut against a surface area of a patient's skin, and an angle formed between the surface area of the patient's skin and a longitudinal axis of the catheter adapter channel may be greater than 4 degrees.

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: An organizing, safety and securement device for use with a peripheral intravenous catheter includes: (a) a catheter base with an opening, that is covered by a transparent membrane, and an upper securement element with a luer fitting indentation, (b) a lower securement element having a top surface with a luer fitting indentation (c) an organizer base with upper and lower clamping members that are hinged together and have free surfaces with tubing indentations that include color coded, mainline and apinch tubing portions, and (d) a tether which connects the catheter and organizer bases.

Abstract: An absorbent stoma pad for encapsulating an external bolster of a feeding tube is provided. The stoma pad includes an upper layer, base layer, absorbent material, and cavity. The upper layer, which includes an upper surface and a lower surface, contains a centrally located opening with respect to a periphery of the upper layer, wherein the opening is configured to receive a tube portion of the feeding tube. The base layer, which includes an upper surface and a lower surface, contains a centrally located opening with respect to a periphery of the base layer, wherein the opening is also configured to receive the tube portion of the feeding tube. Meanwhile, the absorbent material is disposed adjacent the upper layer's lower surface. Further, the cavity permits airflow between the absorbent layer and the base layer when the external bolster is encapsulated by the stoma pad and positioned within the cavity.

Abstract: Certain embodiments provide a cannula system with a retention mechanism comprising a cannula, a hub coupled to the cannula, wherein a distal end of the cannula is configured to be inserted into a body part up to the hub, and a retention mechanism configured to create resistance for retaining the cannula inside the body part in response to force exerted on the cannula for pulling the cannula out of the body part. The retention mechanism may include retention elements coupled to a bottom surface of the hub, and by rotating the hub in a first direction, the one or more retention elements that are parallel to a surface of the body part are configured to penetrate the body part. In other embodiments, the retention mechanism may include halfpipe elements that pivot on fulcrum points to hold or release the hub and cannula from the body part.

Abstract: A holder for securing a venous access device to a patient may include a flexible substrate having an upper surface, a lower surface, and an outer perimetal surface. An adhesive layer may overlay the lower surface of the flexible substrate. The adhesive layer may have an adhesive for adhering to skin of the patient. The holder may further include a hydrophilic matrix integrated into at least a portion of the adhesive layer, at least one solvent reservoir disposed on the upper surface of the flexible substrate, and a connector secured to the outer perimetal surface. The connector may have a first end for connection to a needle assembly and a second end for connection to an IV fluid line.

Abstract: A stabilisation system for securing a medical device such as a catheter to tissue, in particular skin, the stabilisation system comprising a main body having a first section and a second section displaceable relative to one another to translate the system between an undeployed state and a deployed state, each section including an array of microneedles extending from a tissue contacting surface of the body and which penetrate the skin in response to the above displacement, the stabilisation system further comprising a closure member displaceable between an open position exposing a retention zone on the body and a closed position at least partially occluding the retention zone, within which retention zone the catheter or other medical device may be captured.

Abstract: A support device to support a catheter assembly may include a platform, which may include an upper surface and a bottom surface. The support device may include an extension element coupled to the upper surface of the platform. The extension element may include a distal end, which may include a first connector configured to couple to the catheter assembly, and a proximal end, which may include a second connector. The extension element may include a valve that may be movable between a first position and a second position. In response to the valve being moved to the first position, a fluid pathway extending through the cannula and the extension element may be open and straight. In response to the valve being moved to the second position, the fluid pathway may be closed. The support device may include a cannula, which may be swaged within the extension element.

Abstract: Fluid communication devices and supporting structures may be provided for use with intraosseous devices. Apparatus and methods may also be provided to communicate fluids with an intraosseous device.

Abstract: A label sticker includes a release layer strip, an attachment layer strip and a label layer strip. The attachment layer strip is made of an artificial dressing material and its lower surface is coated with or adhered to a first glue layer. The lower surface of the attachment layer strip is attached to the upper surface of the release layer strip through the first glue layer. The label layer strip is made of a waterproof material and its lower surface is coated with or adhered to a second glue layer. The lower surface of the label layer strip is attached to the upper surface of the attachment layer strip through the second glue layer. The label sticker, to be adhered to the human skin to serve identification purposes, can be manufactured by mass production but is unlikely to be wetted and smeared.

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.

Abstract: A medical device for fixing a catheter to a patient is disclosed. It includes a base having a planar main development, a first face configured to be glued to a patient's skin, a second face, opposite to the first face, adapted to receive a catheter according to an axis of insertion of the catheter, and at least two pegs which rise substantially perpendicular to the second face. Each peg has a stem which rises from the second face and has a cross section suitable to freely pass through a through hole of a fin of a catheter. The peg also has an enlarged free terminal end having a cross section greater than the cross section of the stem so that it cannot freely pass through the through hole. The enlarged terminal end is able to pass through the through hole only by elastically widening the through hole.

Abstract: A cannula assembly includes an elongate shaft assembly that is adjustable by a clinician to vary the length of the cannula assembly. In particular, the elongate shaft assembly may be transitioned to provide various lengths of the cannula assembly by selectively positioning a plurality of segments of the elongate shaft assembly. In this manner, a single cannula assembly may be tailored to each patient or a surgical procedure being performed.

Abstract: A medical device (100) for securing a catheter (700) to a support (600) is described, comprising a base element (200) having a first side (201) fixable to the support (600), and a second side (202) opposite the first side (201), and comprising a top element (500) having a first side (501) connectable with the second side (202) of the base element (200). When the first side (501) of the top element (500) is connected with the second side (202) of the base element (200), the top element (500) and the base element (200) are arranged for forming a feedthrough for the catheter (700) between the second side (202) of the base element (200) and the first side (501) of the top element (500). At least one of the base element (200) and the top element (500) comprises a deformable fluidum filled chamber (430), the deformable fluidum filled chamber (430) arranged such that the catheter (700) is locally tightly held between the base element (200) and the top element (500) when positioned there between.

Abstract: An on-body drug delivery device having a housing carried by a substrate. The device includes an adhesive module placed over at least a portion of said device to provide added securement of the device to the patient's body.

Abstract: Embodiments described herein relate to encasements for protection of central lines, arterial lines, and/or intravenous (IV) lines from contaminants, and methods of making and using the same. In some embodiments, an encasement device can include a flexible sleeve that fits over a central line and protects the central line from contaminants. The flexible sleeve has a first open end and a second open end. A first closing element secures the first open end to a medical dressing and a second closing element secures the second open end in a closed position at a location distal to the first closing element. In some embodiments, the central line can include an intravenous (IV) catheter, a peripherally inserted central catheter (PICC) and/or a hemodialysis line. In some embodiments, the device can include a flap coupled to the flexible sleeve.

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: A catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end. The catheter system may include a connector coupled to the proximal end of the catheter adapter. The connector may include a T-connector. The catheter system may include a connector support device, which may be wedge-shaped to support the connector at an insertion angle.

Abstract: A securement device for securing a catheter includes a retainer, a strap, a first anchor pad and a second anchor pad, a gap separating an edge of the first anchor pad from an adjacent edge of the second anchor pad. The retainer can include a first base member secured to an upper surface of the first anchor pad, a second base member secured to an upper surface of the second anchor pad, and a body coupled to the first and second base members. The body can include a portion spanning the gap separating the first anchor pad from the second anchor pad. The portion of the body can include an open channel through an upper surface of the body, the open channel aligned with the gap. The body can further include a first securement mechanism and a second securement mechanism. The strap can be rotatably coupled to the body.

Abstract: A surgical access device includes a cannula body, a fixation mechanism, and an illumination mechanism. The fixation mechanism includes a collar, a sleeve, an expandable member, and a distal ring. The illumination mechanism includes at least one light disposed on the expandable member, and a switch. Distal translation of the collar relative to an elongated portion of the cannula body causes the expandable member to move from a first position defining a first gap between a mid-portion of the expandable member and the elongated portion of the cannula body, to a second position defining a second gap between the mid-portion of the expandable member and the elongated portion of the cannula body, the second gap being greater than the first gap.

Abstract: The invention relates to a surgical apparatus, in particular a navigation probe for localizing and treating lesions in a brain, comprising a telescopically expandable body member having an anterior end, a posterior end, and comprising a top part and a bottom part, the bottom part having at least one groove extending for a particular length in a longitudinal direction of the bottom part between said anterior end and said posterior end, the top part being placed on said bottom part and having at least one engaging element that extends into said at least one groove so as to mount the top part on the bottom part moveable in said longitudinal direction, wherein the body member has a substantially circular or polygonal cross-section in the assembled state of the bottom part and the upper part.

Abstract: A wearable drug delivery device and related methods are described. The wearable drug delivery device can include: a housing; a flexible bag disposed within the housing; a cannula in fluid communication with the flexible bag; and a pumping mechanism for forcing a drug from the flexible bag and into the cannula, wherein the pumping mechanism is proximate the flexible bag and includes a spring-loaded paddle or a driving bag.

Abstract: An infusion set that has a base having an opening to receive a cannula device, the base having a lower base part and an upper base part, wherein the upper base part is coupled to the lower base part and is rotatable relative to the lower base part and a connector that has a fluid connector tube. The connector prevents the upper base from substantially rotating relative to the lower base and the fluid connector tube is in fluid connection with the cannula device when the connector is coupled to the base.

Abstract: Method and apparatus for providing an integrated transmitter unit and sensor insertion mechanism is provided.

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: The present disclosure provides a device that includes a tube having a first end and a second end. The device also includes a stopper coupled to a surface of the tube adjacent to the second end of the tube. The stopper is configured to extend radially from the surface of the tube. The device also includes a first rib coupled to the surface of the tube. The device also includes a second rib coupled to the surface of the tube. The first rib and the second rib are positioned opposite one another on the surface of the tube between the first end of the tube and the stopper.

Abstract: In accordance with an aspect of the present disclosure, an apparatus for suturing tissue is provided that includes a body having a proximate end and a distal end. A suturing head is coupled to the distal end of the body, including a first set of curved needles, a second set of curved needles, and a plurality of sutures. A first end of a suture is coupled to one of the curved needles of the first set. A second end of the suture is coupled to one of the curved needles of the second set. The curved needles of the first set are oppositely oriented to the curved needles of the second set. The suturing head can be positioned between two substantially parallel sections of tissue. An actuator is coupled to the body to deploy the first and second sets of curved needles.

Abstract: Herein disclosed are nasal inserts for treatment and/or management of various different ailments. Easy modification of the insert allows for treatment of various ailments that can readily be treated via the nose. The insert can direct air into or out of the nasal cavity and/or deliver medicinal substances and/or non-medicinal substances to the appropriate regions, thereby providing the appropriate therapeutic effect, depending on the ailment being treated.

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 of the present apparatuses include a flexible vascular graft defining a lumen and a hub having a distal end configured to penetrate a blood vessel, a proximal end, and a wall extending between the distal end and the proximal end that defines an interior passageway. In some apparatuses, the vascular graft is non-removably coupled to the hub, and the lumen of the vascular graft is in communication with the interior passageway of the hub. Some apparatuses include one or more helical protrusions fixed in relation to the wall and configured to secure the hub relative to the blood vessel, each of the one or more helical protrusions extending away from the interior passageway. In some apparatuses, the wall has an outer surface defining an annular recess that extends around the wall, the recess configured to receive at least a portion of a wall of the blood vessel.

Abstract: A tube stabilising device (10, 20, 30) for a tube attached to a patient, comprising a base member (110, 210, 310) fixable to a surface, the base member having a support surface (112, 212, 312) for supporting the base member on a surface of the patient. The tube stabilising device further comprising a tube retaining member (120, 220, 320). The base member includes a cavity (114, 214, 314) configured to receive a flange (122, 222, 322) of the tube retaining member such that, when received, the cavity at least partially overlaps the flange so that the flange is retained by the base member, the tube retaining member is moveably attached to the base member and the flange is moveable within the cavity in any direction parallel to the support surface. The tube retaining member is configured to retain a tube extending from the patient such that, when retained, the tube is moveable relative to the base member.

Abstract: Gastric and intestinal feeding tube devices and methods can be enhanced to provide better patient outcomes. For example, this document provides gastric and intestinal feeding tube devices that include an external bumper with pressure sensors and pressure indicators that facilitate usage of the feeding tube devices within an appropriate range of skin surface pressure. This document also provides external bumpers with deflectable elements that facilitate the application of a controlled amount of force between the external bumpers and the skin surface.

Abstract: A tissue repair apparatus includes a housing, a rotatable shaft at least partially disposed within the housing, and first and second curved needles coupled to the shaft. The housing defines a gap between a first edge of the housing and a second edge of the housing, the gap adapted to receive tissue. The first and second needles curved needles being articulable within the housing from a delivery position, at which the first and second needles are spaced from the gap, to a deployed position, at which the first and second needles extend through the gap. Actuation of the shaft simultaneously articulates the first and second needles and the first needle enters the gap before the second needle enters the gap.

Abstract: An electrostimulator implant includes an implant body, and at least two electrodes disposed on the implant body. The implant is percutaneously injectable into tissue of a subject with a distal portion of a flexible longitudinal member coupled to the implant. The apparatus is configured to be left, for at least 1 day after injection of the implant into the tissue, in a state in which (i) the implant is disposed within the tissue, (ii) the distal portion of the longitudinal member remains coupled to the implant within the tissue, (iii) a proximal portion of the longitudinal member is disposed outside of the tissue, secured to a skin surface of the subject, and (iv) the implant is movable within the tissue by moving the proximal portion of the longitudinal member. The longitudinal member is decouplable from the implant from outside of the subject. Other embodiments are also described.

Abstract: Trapping catheter and kit and method for preparing a trapping catheter A trapping catheter (10) for insertion into a guide catheter assembly (3) comprises a balloon (22) and a trapping catheter body (23) bounding an inflation lumen (24) extending longitudinally within the trapping balloon catheter. The inflation lumen has a distal end opening (25) into an internal space bounded by the balloon. The trapping catheter body is provided with a stopper (26) for abutting against an abutment (27) at a proximal end (27) of the guide catheter assembly so as to determine a maximum insertion depth of the trapping catheter into the guide catheter. A kit and method for preparing a trapping catheter prior to insertion into a guide catheter is also described.

Abstract: A surgical device comprising an instrument shaft having a proximal end and a distal end, a control handle connected to the proximal end of the instrument shaft, a surgical end effector connected to the distal end of the instrument shaft at a joint, wherein the surgical end effector is configured to articulate, at the joint and with respect to the instrument shaft, about an articulation axis, and wherein the surgical end effector had a pull-to-release articulation lock configured to retain the joint in a fixed position and the control handle has an articulation lock actuator that is configured to, when actuated, release the articulation lock.

Abstract: A dual functioning instrument set, comprising a needle and guide, has not only the capabilities to enter and insufflate the abdominal cavity but also the ability of a suture passer to carry and retrieve suture for closure of the incision sites at the end of the procedure. The needle contains a deployable snare that is used to pass and retrieve suture. The guide is used to repeatedly locate the needle relative to the inner abdominal wall allowing for consistent placement of sutures. For insufflation purposes, obturator tips having different distal structures are provided for shielding the sharp needle tip after insertion through a body wall.

Abstract: A medical device kit includes a tunneling tool configured to form a tunnel through patient tissue for receiving an electrical stimulation lead. The tunneling tool includes a tunneling-tool body having an elongated shape with a proximal portion and a distal portion. The tunneling-tool body is formed from a material configured to be manually bent prior to insertion into patient tissue to conform to an anatomical contour through which the tunnel is to extend. A blunt tip is disposed at the distal portion. The blunt tip is configured to tunnel through patient tissue. A tunneling-tool suture-receiving element is disposed along the proximal portion of the tunneling-tool body. The tunneling-tool suture-receiving element is configured to receive a suture extendable along the tunnel formed by the tunneling tool.

Abstract: Example embodiments relate to surgical devices, systems, and methods. The system may include a port assembly. The port assembly may be for use with a surgical arm assembly having a surgical arm and elongated anchor section. The port assembly may include a first main body having an elongated body and a main channel. The main channel may be formed by a portion of an interior surface of the elongated body. The main channel may extend between the proximal and distal ends of the elongated body. The first main body may include an instrument gate secured at a proximal end of the main channel. The instrument gate may include an expandable opening configured to be in a persistently closed position. The expandable opening may be configurable to adaptively expand to a shape of a cross-section of a surgical arm when the surgical arm is inserted through the expandable opening.

Abstract: A urinary catheter support configured to support an indwelling urinary catheter such that the urinary catheter is secured relative to the penis of a male patient includes a flexible main body having an interior size and configured to receive and accommodate the penis of the male patient. A catheter support is located at a front end of the main body and is configured to support a catheter adjacent a longitudinal axis of the main body. A slot extends along the longitudinal axis through the main body and the catheter support. A strap includes first and second end segments and a middle segment between the first and second end segments. The first and second end segments respectively extend through first and second openings in the main body, and the middle segment extends through an interior of the main body.

Abstract: The invention includes a transradial introducer sheath support and integral hemostasis device. The device includes a wristband and an introducer sheath support mount attached to the wristband. The wristband is made from a flexible and resilient material that is applied to the distal forearm of the patient or other desired location on the patient. The support mount may be a molded unitary structure, such as made from a thermoplastic material, and is attached directly to the outer surface of the wristband. An inflatable hemostatic element is incorporated in the wristband and mounted to an interior surface of the wristband. The hemostatic element may be selectively inflated to apply pressure to a radial access point of the patient during and after removal of the transradial introducer sheath from the patient. Another embodiment provides a hemostatic element by a rotatable clasp of the sheath support mount.