Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal end face, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position exposed on or spaced from the distal end face. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a substantially straight configuration to a dual hinged curved configuration that maneuvers and positions the electrodes in the vicinity of the bundle of His. The sheath may include a PTFE liner having axially oriented, platelet-like fibril features that enable the sheath to be split along its length from a proximal end to the distal end.

Abstract: A medical apparatus for guiding an elongated flexible instrument includes an elongated support assembly having a longitudinal axis. The elongated support assembly is adapted to laterally receive into engagement and longitudinally support the elongated flexible instrument. The elongated support assembly includes a guide channel configured to laterally receive the elongated flexible instrument, a fastener configured to laterally receive a mating fastener component of the elongated flexible instrument, or an undulated lateral opening extending longitudinally along the elongated support assembly.

Abstract: A catheter system includes a catheter, a recovery sheath, and an outer sheath assembly. The catheter includes an elongate body having an expandable medical device coupled with a distal end thereof. The recovery sheath is disposed around a proximal section of the catheter body, and is sized and shaped to receive the expandable medical device therein. The recovery sheath is axially movable relative to the catheter body. The outer sheath assembly includes an outer sheath disposed over the catheter body. The outer sheath includes an elongate body that extends from a proximal end to a distal end, where the proximal end of the outer sheath body is positioned distally of the recovery sheath. The outer sheath includes a retention section sized and shaped to receive the expandable medical device therein and constrain the expandable medical device in a stored configuration. The outer sheath is removable from the catheter body.

Abstract: A system for placement of biocompatible electrodes in an opening formed in a patient's body part, such as DBS electrodes inserted into a patient's skull during surgical procedures in the brain. The system includes a coupled catheter and annulus. The catheter includes a guide tube having at least three cooperating guide elements configured to releasably fit together and collectively form a continuous lumen through the catheter that is dimensioned to receive an electrode therein. The annulus is configured to be placed in the opening formed in the patient's body part, and to receive the catheter therethrough. A track mechanism is used to operably couple the catheter to the annulus.

Abstract: A medical introducer includes an elongated tubular member having a proximal end, a distal portion, and a central lumen extending from the proximal end to a distal port in the distal portion. A frame structure is coupled to the distal portion of the elongated tubular member, where frame structure supports the distal portion of the elongated tubular member in a tapered shape and alternatively in a non-tapered shape. The elongated tubular member may include a rigid outer tube and a rigid inner tube carried in an interior lumen of the outer tube. The distal portion is typically a reinforced elastomeric tubular extension of the outer tube, and the reinforced elastomeric tubular extension may have a conical shape.

Abstract: An expandable introducer sheath with an interlock dilator. The present technology provides an expandable sheath with a step feature inside its distal opening, and a dilator with an interlock that includes a catch surface configured to engage with the step feature and resist further relative movement so that the body of the dilator is prevented from exiting the distal end of the expandable sheath. This interlocking engagement may allow the dilator to be used to extend and maintain tension on the expandable sheath during insertion into a patient, and then to be retracted from the expandable sheath by pulling the dilator in the opposite direction. The present technology also provides a dilator hub with a spring mechanism configured to achieve and maintain a desired tension on the expandable sheath and to prevent overextension of the expandable sheath when the dilator is being inserted into the expandable sheath.

Abstract: Provided are drainage systems that may include a drainage manifold and may be suitable for draining fluid from a tissue site. The drainage manifold may include a plurality of elongate members having a moveable end that may be adapted to configure the drainage manifold to treat a uniquely shaped tissue site. The drainage manifold may be coupled to a drainage tube with a transitional connector to provide a drainage system capable of distributing reduced pressure to the tissue site to enhance the drainage of fluids.

Abstract: An introducer sheath for providing access in a patient's body comprises a tubular body with a distal portion and a proximal portion, the proximal portion being configured to be inserted into the patient's body to allow a medical device to be inserted through the introducer sheath into the patient's body. In order for the introducer sheath to be removable from the patient, it can be separated along its length in a longitudinal direction. The introducer sheath further comprises at least a first handle which is pivotable about a fulcrum. The first handle has a first end portion and a free second end portion so as to form a lever, such that pivoting the handle about the fulcrum causes a contacting portion of the handle to act on a respective counter portion that is operatively connected to the distal portion of the tubular body. This creates a breaking force that causes the distal portion of the tubular body to break.

Abstract: The present invention relates to a vascular closure device, comprising a self-expanding tubular vascular closure element, a retaining element surrounding the vascular closure element, the retaining element being arranged to hold the vascular closure element in the lumen of the retaining element in a configuration where the vascular closure element is not fully self-expanded, a tether that is threaded through the lumen of the retaining element, the tether being arranged so that, upon application of a first force to the tether which is greater than a threshold force, the tether disintegrates the retaining element so as to allow the vascular closure element to freely expand. It also relates to a system for delivering such a vascular closure device and to a method of closing a vascular access hole using a corresponding device.

Abstract: An irrigating intraluminal suction inner cannula system for a tracheostomy tube may be a suction-powered system that may be used for suction alone or a combination of rinse and intraluminal suction for tracheostomy tubes in place of conventional catheter-based intraluminal suction. An inner cannula includes chambers, or regions, and holes that facilitate intraluminal suction and cleaning at multiple locations within the tracheostomy tube. It may be applied/actuated by a patient, healthcare worker, caretaker, or via an electronic system either on-demand or on regular or triggered intervals, in either inpatient/hospital or outpatient/ambulatory care setting.

Abstract: A diagnostic and prognostic method and system for sequentially analyzing in a biological fluid or tissue extract the presence of an antigenic infectious agent, infectious organism or its toxic product; an antibody response to the antigenic infectious agent, infectious organism or its toxic product; one or more biomarkers formed during infection in response to a communicable disease; and one or more biomarkers to assess the severity of the disease and to monitor the effectiveness of drug therapy or vaccination.

Abstract: An expandable introducer sheath with an interlock dilator. The present technology provides an expandable sheath with a step feature inside its distal opening, and a dilator with an interlock that includes a catch surface configured to engage with the step feature and resist further relative movement so that the body of the dilator is prevented from exiting the distal end of the expandable sheath. This interlocking engagement may allow the dilator to be used to extend and maintain tension on the expandable sheath during insertion into a patient, and then to be retracted from the expandable sheath by pulling the dilator in the opposite direction. The present technology also provides a dilator hub with a spring mechanism configured to achieve and maintain a desired tension on the expandable sheath and to prevent overextension of the expandable sheath when the dilator is being inserted into the expandable sheath.

Abstract: This method for manufacturing a pipe (2) for a vehicle fuel tank involves—molding a wall, comprising an inner layer (6) made from ethylene vinyl alcohol (EVOH) and an outer layer (8) made from a polymer suitable for welding, in a mold comprising at least one female shoulder that creates at least one male shoulder on an outer surface of an end portion of the wall during molding, then—cutting off the end portion of the wall.

Abstract: A chassis of an oral cleansing device is provided. The oral cleansing device may include a first chassis half including a first threaded portion, a second chassis half including a second threaded portion, and a nut threaded onto the first threaded portion and the second threaded portion to at least partially secure the first chassis half to the second chassis half. The threaded portions may be defined on respective ends of the first chassis half and the second chassis half. The nut may engage chamfered edges of the first chassis half and the second chassis half. Engagement of the nut with the first chamfered edge and the second chamfered edge may produce a radial compressive force on the chassis halves. The first chassis half and the second chassis half may at least partially define a chassis that is positioned within a handle of the oral cleansing device.

Abstract: A low profile catheter system includes a catheter hub with a stabilization surface that is located on an underside of the catheter hub and stabilizes the catheter hub on a patient. A substantially linear flow path extends from an opening at the distal end of the catheter hub to an inlet located within an intermediate portion of the catheter hub. The flow path allows fluid to flow between the distal end and the intermediate portion. The intermediate portion receives a base connector having a fluid path. The fluid path has a first opening and is fluidly connected to the inlet of the flow path in the catheter hub and a biasing member biases the first opening toward the inlet when the base connector is received by the intermediate portion.

Abstract: A medical device may include an introducer sheath, having a distal and a proximal end and a lumen extending from the distal end to the proximal end. The introducer sheath may also include a tab formed at the distal end and extending distal to the lumen, and a frangible portion extending between the distal end and the proximal end.

Abstract: A catheter structure, such as a balloon catheter (30), guidewire, or the like, with markings (32) perceptible outside of the vasculature is for use in determining at a location external to the body the position of the catheter structure relative to a treatment area. Related kits are also disclosed.

Abstract: A medical device is disclosed including a needle guide. The needle guide includes abase, a guide member, and a handle arrangement. The base defines a base channel and the guide member includes a guide member channel in communication with one another and configured for receiving a flexible needle. The guide member includes a non-linear portion and is generally flexible to accommodate passage of a flexible needle through a corresponding portion of the guide member channel. The handle arrangement is configured to accommodate stabilization of the needle guide during deployment.

Abstract: A delivery device for delivering a pacing lead to the His bundle of a patient's heart includes an elongated sheath having a distal end, and a plurality of mapping electrodes positioned at the distal end. The distal end of the sheath may have a distal end face, and the mapping electrodes may include two electrodes that diametrically oppose one another at a position exposed on or spaced from the distal end face. The sheath includes a plurality of flexible sections spaced apart from one another, and a pull wire that causes the sheath to deflect from a substantially straight configuration to a dual hinged curved configuration that maneuvers and positions the electrodes in the vicinity of the bundle of His. The sheath may include a PTFE liner having axially oriented, platelet-like fibril features that enable the sheath to be split along its length from a proximal end to the distal end.

Abstract: The present disclosure relates generally to the field of devices and procedures for placement of a medical device between adjacent tissue structures. In particular, the present disclosure relates to systems and methods for percutaneous placement of a drainage stent between the gallbladder and gastric lumen (e.g., cholecystogastrostomy), or gallbladder and duodenum (cholecystoduodenostomy).

Abstract: A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Abstract: Methods and apparatuses for blood glucose measurement are provided. A first glucose concentration in a body fluid of a user is detected based on a first measurement interval. A first blood glucose level of the user is determined based on the first glucose concentration. A glucose concentration measurement interval is changed from the first measurement interval to a second measurement interval according to an occurrence of an event. A second glucose concentration in the body fluid is detected based on the second measurement interval. A second blood glucose level of the user is determined based on the second glucose concentration.

Abstract: A guiding apparatus comprises a support assembly extending along a longitudinal axis and including a first plurality of linkages and a second plurality of linkages. The first plurality of linkages includes a first channel formation and the second plurality of linkages includes a second channel formation. The support assembly has a coupled configuration with a proximal end and a distal end in which the first plurality of linkages is coupled to the second plurality of linkages with the first and second channel formations arranged to form a continuous channel through the support assembly. The continuous channel has an opening sized to receive an elongated flexible instrument.

Abstract: The present invention relates to a type of medical instrument, in particular a fifth generation FSN needle, being a special tool for Fu's subcutaneous needling (FSN), comprising a needle handle, a needle core, a soft casing pipe and its handle, and a protective sleeve. The needle core is fixed on top part of the needle handle and consists of a needle core body and a needle core tip. On top part of the needle handle, a round-hole-type groove is provided. On this groove, a positioning notch is provided, including first longitudinal position point, and inlet and second longitudinal position point at two sides of the first longitudinal position point. The soft casing pipe handle is a round tube that can be inserted into said groove. On the soft casing pipe handle, a first bulge and second bulges are provided: the first bulge is used to fix the soft casing pipe and its handle; the second bulges are used to prompt sweep position.

Abstract: A suture guide includes a first part having a first base piece and a plurality of first needle portions joined to the first base piece. Each first needle portion has a respective first needle portion sidewall. The suture guide further includes a second part having a second base piece and a plurality of second needle portions joined to the second base piece. Each second needle portion has a respective second needle portion sidewall. The first part and second part are moveable between a separated configuration and a joined configuration. In the separated configuration, the first needle portions are spaced away from the second needle portions. In the joined configuration, each one of the first needle portions is positioned adjacent and cooperates with a respective one of the second needle portions to form a needle.

Abstract: A manipulator, including an elongated chassis containing a U-shaped channel defining a distal direction and a proximal direction. The manipulator also includes an adjuster that is configured to slide in the U-shaped channel. The adjuster includes a first wheel which on rotation translates a guidewire positioned in the adjuster along an axis of the guidewire, and a second wheel which on rotation rotates the guidewire positioned in the adjuster about the axis of the guidewire. The adjuster also includes a port, distal to the first and the second wheel, that is configured to accept a tubular balloon and the guidewire.

Abstract: A catheter system and method of dilating first and second anatomies includes a guide catheter extending along a longitudinal axis that has a breakaway distal end portion with a conduit in communication with the lumen. The conduit is configured to guide a dilation catheter at a first predetermined angle relative to the longitudinal axis and a second predetermined angle relative to the longitudinal axis for respectively dilating the first and second anatomies. The breakaway distal end portion includes first and second guide segments at least partially defining the conduit and respectively extending the first and predetermined angles to first and second distal openings. The second guide segment is removably connected to the first guide segment for selectively guiding the dilation catheter along the second predetermined angle when connected and along the first predetermined angle when disconnected.

Abstract: A vascular access disassembling needle assembly 20 is provided that enables rapid insertion of a guide wire into the needle and subsequent rapid removal of the access needle off the guide wire by facile disassembly of the needle. The disassembling needle assembly 20 includes a needle portion 30 wherein the needle breaks apart by splitting along at least one seam 40 that extends from the proximal to the distal end to allow removal of the guide wire. Various mechanical features are described that can facilitate the separation of the needle body along at least one seam. Once one or more seams are separated, the needle body may be removed from the guide wire without the need to withdraw the needle along the length of the guide wire, which permits preloading of expanders and other medical devices onto the guidewire.

Abstract: Tools and methods for removing anchors from medical leads involve a guide portion and a blade. The lead is inserted within a lead passageway of the guide portion of the tool and the tool is moved along so that the blade contacts the anchor and cuts a slit in the anchor as the tool. Once the blade has cut the slit through the entire anchor, the anchor comes free of the lead and the tool can be removed. The tool may include a manner of opening and closing the guide portion so as to provide access to the lead when open and to contain the lead when closed. Opening the guide portion allows the lead to be inserted or removed by laterally moving the lead into or out of the lead passageway such that the tool may be installed or removed at any available point along the lead.

Abstract: The present invention relates to a device (1) for introducing a flexible prosthesis into a surgical incision, comprising a globally tubular body (2) having a proximal end (2a) and a distal end (2b), said tubular body being designed for receiving the prosthesis in a folded configuration in a sliding way, wherein the tubular body is provided with an open longitudinal slit (3) extending from said proximal end (2a) to said distal end (2b), and wherein said distal end is provided with a distal semi-tubular rounded extension (2c).

Abstract: A variety of location-based and/or proximity-based features related to diabetes management systems can be used to improve maintenance compliance and/or to provide important information to PWD designated assistance entities (e.g., family, friends, givers, HCPs, emergency medicine providers) under certain conditions. In some cases, a user's location can be tracked or determined to trigger and/or time alerts about upcoming maintenance tasks in a way that will increase the likelihood that the PWD will immediately perform the designated maintenance task. In some cases, methods, devices, and systems provided herein can use proximity to non-paired mobile computing devices to deliver data to PWD designated assistance entities.

Abstract: A minimally invasive surgery suction sleeve configured for use with an inner cannula of a suction instrument. The sleeve includes a first opening at a proximal end, a second opening at a distal end, and a tube between the first opening and the second opening. The sleeve slides over a suction instrument. The distal end is configured to insert into the body and includes a plurality of apertures that provide for pool suction. The sleeve further includes a flange at the proximal end that allows a surgeon to manipulate the sleeve, switching between spot and pool mode by sliding the sleeve over the inner cannula of the suction instrument. In spot mode, the tip of the suction instrument is exposed. In pool mode, the sleeve slides forward, covering the tip of the suction instrument so that fluent material is drawn through the apertures in the sleeve.

Abstract: Some embodiments of a vascular access device are configured to reduce the likelihood of blood leakage during installation, even when the device is optionally installed using a single hand. In particular implementations, the vascular access device is configured as a peripheral intravenous (IV) device.

Abstract: A method, apparatus, and system for cutting anatomic members, such as ligaments, in surgical procedures such as carpal tunnel release, plantar fasciotomy, gastroc release, cubital tunnel release, and tarsal tunnel release is disclosed. The apparatus includes a guide tool for guiding a knife and a scope during surgery which may be employed with a translating knife. Relevant features include a knife stop for preventing the knife from inadvertently raising out of the knife channel, indicia viewable to show the proper orientation for the guide tool, a self dilating tip and channel design on the guide tool, a cover piece and/or pivotable panel system for preventing ligaments and other anatomy from getting caught in the guide tool, a pivot pin and groove system for stabilizing the knife and also assuring that the knife blade is not inadvertently raised out of the channel, and a use indicator employable to prevent re-use of the device.

Abstract: A histopathology system includes an elongated, cylindrical probe having scanners connected to a distal end of the probe and configured to capture digital images of tissue, a mesh net connected to the distal end of the probe and configured to grasp tissue, and control circuitry configured to expand and contract the mesh net to grasp the tissue being examined. The system includes an outer sheath into which the probe is inserted having one or more tabs extending from the outer sheath to affix the outer sheath at one or more locations. An elongated, cylindrical introducer device guides the outer sheath through a bodily orifice or surgical incision when the introducer device is inserted into the outer sheath. At least one server with processing circuitry is configured to digitally stain a tissue image obtained by the scanners of the tissue, and match the tissue images to stored tissue samples.

Abstract: An apparatus for guiding a flexible instrument comprises an elongated support assembly having a longitudinal axis. The elongated support assembly is adapted to laterally receive into engagement and longitudinally support an elongated flexible instrument.

Abstract: A body (2) for a catheter or sheath is disclosed. The body (2) includes strips (8, 10) formed longitudinally from the proximal (6) portion of the body (2) to the distal (4) portion of the body (2). The strips are formed of different materials. The strips can have different radiopacities, or can be splittable/peelable. The splittable/peelable body comprises a peel mechanism longitudinally extending along its respective length. The peel mechanism can be formed by longitudinally extending regions of interfacial bonding between first and second longitudinally extending strips of polymer material. A region of stress concentration extends along the region of interfacial bonding. The stress concentration facilitates the splitting of the body (2) along its peel mechanism. The polymer material of the first strip (8) can have a greater amount of radiopaque filler than the polymer material of the second strip (10). Each strip forms at least a portion of an outer circumferential surface of the body (2).

Abstract: A balloon coating method for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter includes: fixing a connection portion between the balloon and an inner tube penetrating an inside of the balloon in such a manner as to clamp the connection portion by at least two clamping portions each having a groove-shaped curved surface extending along an axis of the inner tube; pulling the balloon in an axial direction of the balloon by the clamping portions to thereby straighten a bend of the balloon; and moving a dispensing tube for supplying a coating liquid containing the drug relative to the balloon in the axial direction of the balloon, while rotating the balloon about an axis of the balloon, to thereby coat the outer surface of the balloon with the coating liquid.

Abstract: Injection systems powered, controlled and network-enabled by a mobile device, and methods for powering and controlling an injection system using a mobile device, are disclosed. An injection device includes a fluid container having a fluid container exit port, an injection driving element adapted to displace fluid from the fluid container through the fluid container exit port, and a connection module connected to the injection driving element, connectable to a mobile device, and adapted to receive electrical power or injection input data from the mobile device.

Abstract: A one-piece connector for removing a housing and needle of a Huber needle assembly from a patient. The connector has a frame that can be positioned about a surface on the housing of the needle assembly and a pair of wings that pivot toward one another to provide a gripping surface.

Abstract: An infusion set component of a fluid infusion device and/or a fluid infusion port component for delivery of fluid to a patient is compatible with a cooperating fluid channel module. The fluid channel module includes a body section having coupling features to mate with a base of the component. The fluid channel module also includes an interior fluid flow channel formed within the body section to receive fluid from the fluid infusion device and/or from a syringe or pen delivery device. The fluid channel module also includes a conduit having a first end in fluid communication with the interior fluid flow channel, and having a second end to deliver the fluid to the patient.

Abstract: Power injection catheters for high flow rate delivery of fluids are disclosed. In one embodiment, a catheter may include a body defining one lumen and a plurality of extension tubes each comprising a lumen in fluid communication with the one lumen of the catheter body. Further, an extension tube may be configured for performing power injection and an extension tube may include a proximal valve. In another embodiment, a catheter may comprise a plurality of lumens and extension tubes, each of the extension tubes comprising a lumen in fluid communication with one lumen of the catheter body, respectively. At least one extension tube may be configured for performing power injection and at least one extension tube may include a proximal valve. Such catheters may include a pressure relief mechanism for preventing overpressurizing of the catheter. A method of injecting a fluid into a patient's body is disclosed.

Abstract: A catheter system including an insertion device and a catheter device. The insertion device includes a housing, a latch, a needle for insertion into a patient; and a spring. The catheter device includes a housing comprising a chamber, and a seal disposed in said chamber. The seal is configured to reseal when the needle is withdrawn from the seal such that blood is sealed in the chamber. The spring relaxes and thereby retracts the needle entirely into the housing of the insertion device when the latch decouples from the catheter device.

Abstract: A device for clearing blockages is provided that may have a tube that is slit. The tube may have a lumen. A reciprocating member may be provided and a portion of the reciprocating member may be located within the lumen.

Abstract: Novel catheter systems including those having guidewire lumens that can convert from an Over-the-Wire mode to a Rapid Exchange mode are useful and effective when crafted such that this conversion happens without adjusting the position of the guidewire in a body lumen.

Abstract: The safety needle assembly includes a body and a wing assembly secured to the body. A grip is slidable along the exterior of the body, and a needle holder is slidable through an interior passageway in the body. The grip slides independently of the wing assembly, which is not slidable with respect to the body. The grip and the needle holder are secured to one another, so that sliding movement of the grip induces sliding movement of the needle holder. The grip and the needle holder are slidable between a distal position, in which a sharp distal tip of a needle held in the needle holder is exposed, and a proximal position, in which the sharp distal tip is not exposed.

Abstract: A needle comprises an elongated first shaft element with a C-shaped cross section and an elongated second shaft element with a C-shaped cross section. The first shaft element and the second shaft element are adapted to be detachably connected to each other. This is achieved by an overlap of respective end sections of the first and second shaft elements. Within the channel formed by the shaft elements, an optical probe may be accommodated from which the shaft elements may be removed by separating the two shaft elements from each other.

Abstract: The present invention generally provides methods and devices for removing fluid from a surgical instrument. Surgical access devices and seal systems are generally provided having one or more valves or seal assemblies to create a closed system between the outside environment and the environment in which the surgical access device is being inserted. In one embodiment, a seal assembly is provided and can include a seal having an opening configured to receive a surgical instrument therethrough and a fluid remover in the form of a sorbent element, a scraper element, a wicking element, or any combination thereof can be associated with the seal and configured to remove fluid from the opening and/or a surgical instrument.

Abstract: An apparatus for delivery of an elongate member into the lumen of a trans-dermal catheter. In a preferred embodiment, the apparatus comprises a protective sheath configured to at least substantially surround an elongate member; and slidable member configured to travel along the protective sheath, the slidable member operatively coupled to the elongate member; wherein the elongate member is insertable into a lumen of a trans-dermal catheter by moving the slidable member along at least a part of the length of the protective sheath.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and can include a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.