Abstract: To provide a packaged medical device in which a medical device in a container is stably fixed and which can be easily opened. Specifically, provided is a packaged medical device comprising a container having an opening portion and a flange portion formed to extend outward in a peripheral portion of the opening portion, a medical device housed inside the container, and a lid member having a gas impermeable film and peelably heat-sealed to the flange portion, in which the inside of the container is set to a negative pressure to the atmospheric pressure so that the medical device is pressed by the lid member and the peel strength to the flange portion of the lid member is 2 to 50 N/in.

Abstract: A medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive. A support member may be coupled to the retainer. The support member may include a channel configured to receive a proximally extending portion of the medical article.

Abstract: A cartridge for coupling to a conducted electrical weapon to launch electrodes toward a target to provide a current through the target to impede locomotion of the target. The cartridge includes a cover that covers a forward portion of the cartridge. The cover may be over molded on the forward portion of the cartridge. The cover includes a frangible portion. The frangible portion may surround the perimeter of a door or be positioned between flaps. The frangible portion may be broken to separate the door from the cover or to disengage the flaps so they can move. The electrode may launch through a door opening or between the flaps to travel toward the target.

Abstract: A portable compression system for preventing deep vein thrombosis is provided. The portable compression system includes an inflatable apparatus comprising a monitor unit and at least one inflatable air cell. The portable compression system further includes an outer cuff comprising a pocket configured to receive the inflatable apparatus, the outer cuff configured to be wrapped around a portion of a patient's body where prevention of deep vein thrombosis is desired. The portable compression system further includes a disposable sleeve barrier configured to provide a physical barrier between the outer cuff and the portion of the patient's body.

Abstract: A package for containing a medical device including peel stops located in the first side seal zone and the second side seal zone of a peripheral seal of package, wherein the first and second peel-stops limit peeling of the first and second side seal zones of the peripheral seal.

Abstract: A system for containing and transporting a medical device may include a container including a bottom face and surrounding side faces as a closed first end and an open second end to form an inner portion for receiving and retaining the medical device. The liner may be extendable over the side faces to line the inner portion of the container to an outer surface of the bottom face of the container. The liner may act as a protective barrier to the container to minimize contamination when receiving and/or retaining a used medical device. First and second covers may be removably attachable to the container, over the liner, to enclose a medical device therebetween. A first cover may have a color or marking indicating the medical device is “clean”, while a second cover may have a color or marking indicating the medical device is “used”.

Abstract: A surgical instrument system includes a pair of side-specific orthopaedic surgical instrument assemblies. The right-limb side-specific instrument assembly is kitted so as to be devoid of left-limb side-specific instruments and vice versa.

Abstract: A drug delivery device that includes a housing. The housing contains a syringe, and the syringe includes a container containing a liquid medicament. The container includes an aperture at a distal end and through which the liquid medicament can be dispensed. The syringe includes a stopper within the container. The stopper is moveable between a first longitudinal position and a second longitudinal position relative to the container, to cause dispensing of the liquid medicament through the aperture. The syringe includes at least one identifying means identifying the liquid medicament.

Abstract: A bone implant holding and shaping tray is provided. The tray includes a first segment having a distal end and a first surface sized to hold and shape at least a portion of the bone implant with bone material. The tray includes a second segment having a second surface sized to hold and shape at least a portion of the bone implant with bone material, the second segment having a proximal end configured to be coupled to the distal end of the first segment so as to extend the first surface to hold and shape the bone implant. Methods of making and using the bone implant holding and shaping tray are also provided.

Abstract: A packaging device for a trocar assembly includes a trocar packaging clip having at least two holding structures configured to be detachably secured to the proximal portions of the trocar obturator and the cannula for retention of the trocar obturator and cannula relative to each other. The trocar packaging clip includes an anti-rotation structure configured to engage at least one of the trocar and the cannula to prevent relative rotation thereof.

Abstract: To provide a packaged medical device in which a medical device in a container is stably fixed and which can be easily opened. Specifically, provided is a packaged medical device comprising a container having an opening portion and a flange portion formed to extend outward in a peripheral portion of the opening portion, a medical device housed inside the container, and a lid member having a gas impermeable film and peelably heat-sealed to the flange portion, in which the inside of the container is set to a negative pressure to the atmospheric pressure so that the medical device is pressed by the lid member and the peel strength to the flange portion of the lid member is 2 to 50 N/in.

Abstract: To provide a packaged medical device which is hard to cause a variation in the fixed states of the medical devices. Specifically, provided is a packaged medical device comprising a container having an opening portion, a medical device housed inside the container, and a gas impermeable film sealing the opening portion by heat-sealing, in which the inside of the container is set to a negative pressure to the atmospheric pressure and the medical device is pressed by the gas impermeable film.

Abstract: Disclosed is a laryngoscope insertion section having a curved superior surface, a curved inferior surface, and a channel extending from the proximal end the channel having an inferior surface with a greater curvature than the curvature of the inferior surface. The insertion section is compatible with laryngoscope hardware optimized for indirect viewing, yet enables direct viewing. The distance between the inferior and superior surfaces is at a maximum within the intermediate portion, and enables the dimensions of the proximal and distal portions to be minimized. Thus, the intermediate portion, located in the patient's oral cavity in use, is provided with greatest depth and strength where the greatest forces are received, whereas the distal and proximal portions are of reduced dimensions to minimize trauma to the patient's airway and mouth areas, respectively. Structural features providing the insertion section with improved strength, with a minimum of material and size, are also disclosed.

Abstract: A sterile drape is provided to cover medical equipment. The drape may include an expandable element to open the open end of the drape. A sheath may also be provided to cover the sheath prior to use. The drape may also be held in a container, which may be coupled to the equipment. Furthermore, the drape may include one or more partially deployed positions in which the drape is partially deployed yet the sterile surface of the drape remains unexposed so that the drape may be partially deployed by non-sterile personnel and stored in a non-sterile area.

Abstract: Insert pads used in women's clothing can be difficult to insert, remove, or adjust. The application includes independent methods for each of these scenarios, which are significant improvements over the state-of-the art method of manually massaging into place. By using a specially designed tool with the method laid out herein, it is possible to accomplish these tasks with great effectiveness and in much less time than before.

Abstract: A packaging assembly for an electromagnetic trackable surgical tool and wiring thereof. The packaging assembly includes a first tray with at least one first retention member configured to couple the surgical tool to the first tray. The packaging assembly further includes a second tray configured to couple with the first tray. The second tray has at least one second retention member configured to couple the wiring of the surgical tool to the second tray.

Abstract: A preformed guidewire particularly well-suited for use in percutaneous medical procedures, such as transcatheter aortic valve replacement, includes an inner corewire of discontinuous, tapered stiffness that is surrounded along a portion of its length by a flexible, outer casing of uniform cross-section, such as a tightly wound, stainless steel, spring coil wire. The inner corewire is constructed of a shape-memory material, such as a nickel-titanium alloy, that is preformed into an encircled S-shaped configuration in its atraumatic distal region. Specifically, the distal region includes an enlarged, stiffened, proximate segment that encircles a smaller, more flexible, distal segment. As a feature of the invention, the distal and proximal segments project along fixed-radial arcuate paths that extend in opposite directions from one another. As a result, the distal region is optimally configured to limit the risk of trauma to the immediate site of treatment when inserted through a straightened guide catheter.

Abstract: Packaging systems, surgical kits and methods are disclosed for a tool including a working portion and a shank. The packaging system includes a casing with a distal section defining a cavity configured to receive the working portion, and a proximal section removably coupled to the distal section and being configured to receive the shank of the tool. A sleeve is retained by the distal section and is disposed within the cavity of the distal section. The sleeve defines a lumen adapted to receive the working portion. The sleeve is configured to rotate within the distal section to facilitate rotational installation of the tool relative to a surgical device.

Abstract: The invention concerns a flat package for a non sterile protective pouch (16) receiving a sterile surgical mesh; the package includes: an external envelope (2) including a front panel (3) and a complementary back panel (4), the inner face of the front panel (3) and the inner face of the back panel (4) being bonded respectively with a front layer (17) and with a back layer (18) of an internal envelope (15) made of a moisture-impervious material, the front panel (3) and the back panel (4) being jointed along the contours of the external envelope and, the package having an opening end comprising two tearable portions (8) configured to separate the front panel (3) upon which the front layer (17) of the internal envelope (15) is bonded from the back panel (4) upon which the back layer (18) of the internal envelope (15) is attached.

Abstract: In one aspect of the present disclosure, a sterilization mat is provided that is configured to receive non-sterile surgical instruments, rolled to a rolled configuration, and sterilized while in the rolled configuration. In accordance with another aspect of the present disclosure, a specialized surgical supply kit includes a package that retains surgical supplies having at least one surgical supply identified as a preferred surgical supply by the hospital or surgeon that is to perform the surgery. The surgical supplies are further arranged in a spatial arrangement based on the surgeon who is to perform the surgery.

Abstract: Embodiments relate to expandable tissue cavity markers and corresponding systems and deployment methods. In one embodiment, an expandable tissue cavity marker comprises a pouch and at least one radiopaque marker element. The pouch can transition between a compressed state, in which a profile or dimension of the tissue cavity marker is reduced such that the tissue cavity marker can be deployed through a minimally invasive surgical procedure incision, and an expanded state, in which a profile or dimension of the tissue cavity marker is increased such that the tissue cavity marker fills or defines a volume of a tissue cavity. In one embodiment, the pouch can be transformed between the compressed state and the expanded state by delivery of a fill material into the pouch. The pouch can comprise one or more functional materials in embodiments, including materials that provide an anti-infection, hemostasis, anti-migration, medicinal, or other function to the tissue cavity marker.

Abstract: Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.

Abstract: Methods and apparatus for sterilization are presented. An exemplary embodiment includes a sterilizing cabinet assembly. The sterilizing cabinet includes a cabinet having an access port, a door connected to the cabinet, the door moveable between an open position permitting passage through the access port to an interior of the cabinet and a closed position precluding passage through the access port. The sterilizing cabinet assembly also includes at least one of the cabinet and the door having a vent port. The sterilizing cabinet has a primary filter overlying the vent port and forming a sealed interface with an adjacent portion of the one of the cabinet and the door and a secondary filter overlying at least a portion of the primary filter.

Abstract: Disclosed herein are devices and methods for collecting oral fluids, saliva, or sputum. One exemplary device includes a collection cup with a hollow needle extending from a bottom end of the cup, where the hollow needle is covered with a compressible sleeve. A clear vacuum tube is positioned beneath the hollow needle. Oral fluids, saliva, or sputum from a donor are collected into the collection cup, and the vacuum tube is pushed onto the hollow needle and the hollow needle passes through the compressible sleeve, through a seal of the vacuum tube, and into the vacuum tube. Oral fluids, saliva, or sputum from the collection cup are drawn into the vacuum tube until the vacuum in the vacuum tube dissipates. An oral fluid specimen is, thus, provided ready for laboratory transport, point of collection screening, or diagnostic analysis while the oral fluid specimen is still in the transparent vacuum tube.

Abstract: A package (10a) for containing a medical device (12a) including a front sheet (14a) and a back sheet (15a) wherein each includes a top edge (18a, 23a), a bottom edge (19a) and opposed first (20a, 24a) and second side edges (21a, 25a), the sheets being sealed to each other by a peelable peripheral seal (26a), having a top seal zone (27a), bottom seal zone (28a), and opposed first (29a) and second side seal zones (30a), the sheets being separated to open the package by at least partially peeling the sheets apart along the first and second side seal zones; a first peel-stop (31a) located in the first side seal zone and a second peel-stop (32a) located in the second side seal zone of the peripheral seal, wherein the first and second peel-stops limit peeling of the first and second side seal zones of the peripheral seal.

Abstract: An apparatus for fixing a device in a selected position comprises a base having a deformable adherent material disposed thereon, and at least one stability feature associated with the base that allows the apparatus to be maintained in a location and position. The deformable adherent material substantially conforms to at least a portion of a shape of the device and removably fixes the device in the selected position. Although not limited thereto, the apparatus is useful in surgical and interventional procedures for quickly and reliably fixing a medical device such as a catheter at a selected position and orientation while allowing easy removing and repositioning of the device.

Abstract: Embodiments relate to transformative shape-memory polymer tissue cavity markers and corresponding systems and deployment methods. In one embodiment, a tissue cavity marker for delivery to a tissue cavity via a minimally invasive surgical incision includes a transformative body having a first three-dimensional shape in a permanent state and a second three-dimensional shape different from the first three-dimensional shape in a temporary state, the transformative body comprising a shape-memory polymer material and being automatically transformable between the temporary state for delivery to a tissue cavity and the permanent state for residence within the tissue cavity by application of a stimulus; and at least one radiopaque marker coupled to the transformative body.

Abstract: A valve insertion tool is disclosed. The valve insertion tool may be used in a minimally invasive cardiac surgery. The valve insertion tool includes a housing and a cover, the housing having at least one valve recess and a suture channel. The valve insertion tool is suitable for use in delivering a prosthetic heart valve into a thoracic cavity of a patient during a minimally invasive cardiac surgical procedure. One or more valve insertion tools may be stackable and be pre-loaded with one or more prepared prosthetic heart valves. These one or more valve insertion tools may be packaged as a valve insertion kit.

Abstract: Devices, systems, and methods facilitating surgery include surgical packaging transitionable from a furled configuration to an unfurled configuration. In the furled configuration, the surgical packaging is configured to enclose at least one surgical component therein. In the unfurled configuration, the at least one surgical component is removed from the surgical packaging and the surgical packaging is configured for use during a surgical procedure.

Abstract: The present invention relates to a device for suspending one or more medical instruments, such as a drying cabinet for endoscopes, comprising a closable space, a plurality of holders positioned in the closable space provided with at least one retaining elements and a control system comprising an identification system configured for identifying the holders, wherein the at least one retaining element of each holder is provided with at least one identification means connected to the identification system, wherein the identification means is configured to identify the retaining element of the respective holder.

Abstract: The disclosure relates to a method for unpacking and separating infusion bags into singles for supplying the bags to a device for further processing. It includes the following steps: Opening an outer packaging, in which the infusion bags are present, by an opening device, wherein the infusion bags are fastened in groups to a holding device inside the outer packaging. Separating the group of infusion bags, which are fastened to the holding device, from the outer packaging by a separating device. Position the holding device with the infusion bags fastened thereon in a transport device by a positioning device. Processing the infusion bags by device for further processing.

Abstract: A storage case accommodates a plurality of medical elongated bodies, which are assembled when used, and includes a plurality of pipe bodies wound to form a ring-like shape that are connected to each other in order to accommodate each of the medical elongated bodies, and a package case that collectively accommodates the plurality of connected pipe bodies. At least two of the pipe bodies are disposed side by side so as to overlap each other in a state in which the center axes of winding are deviated, and the pipe bodies have opening portions arranged so that the medical elongated bodies can be assembled within the storage case using no more than two hands.

Abstract: A contact lens package includes a first package layer, a second package layer, a lens receiving area defined between the first and second package layers, and first and second seal portions. The first seal portion extends around a first portion of the lens receiving area. The second seal portion extends around a second portion of the lens receiving area. The second seal portion has different sealing properties than the first seal portion. The first seal portion may include a releasable seal between the first and second package layers, and the second seal portion may include a permanent seal between the first and second package layers.

Abstract: A smartphone protective cover that houses a glucose monitor, test strips, lancets, a lancet striker, a power source, and a biohazard debris receptacle is presented. According to the preferred embodiment of the invention, the protective covering is configured to include a smartphone adapted glucose monitor and also to accept a smartphone. In the preferred embodiment, the smartphone is removably placed into the protective covering with the glucose monitor connecting to a data receptacle on the smartphone. The protective cover further includes a lancet storage compartment adjacent to a lancet striker having a tension control member and striker release button, a test strip storage compartment, and a biohazard debris receptacle. The lancet storage compartment and test strip storage compartment can be re-Tillable or disposable. A battery is also located in the cover and is electrically connected to the glucose for monitor, thus enabling the monitor to be powered independently of the phone.

Abstract: The disclosure herein provides ophthalmic surgical systems, methods, and devices. In one embodiment, a surgical apparatus for use by a surgeon during a surgical procedure comprises one or more sealed sterilized surgical packs configured to be disposed of after a single or a limited number of surgical procedures, the one or more sealed sterilized surgical packs comprising: a sterile surgical instrument; and a sterile surgical tray comprising a top surface configured to be part of a sterile field of the surgical procedure, the top surface comprising a receiving structure for positioning therein of the sterile surgical instrument, the sterile surgical tray further comprising walls that define a recess sized and configured to receive a reusable non-sterile module, the recess configured to encapsulate the reusable non-sterile module to isolate the reusable non-sterile module from the sterile field of the surgical procedure.

Abstract: A Foley catheter kit includes a surface defining a single layer tray with at least two compartments at least partially separated by a barrier. A first syringe is disposed in a first compartment, while a Foley catheter, coupled to coiled tubing and a fluid drain bag, is disposed within a second compartment. The first compartment defines a lubricating jelly application chamber to lubricate at least a portion of the Foley catheter when the portion is passed from the second compartment to the first compartment. Printed instructions for using the single layer tray can be molded into the single layer tray.

Abstract: A waste disposal system with a waste receiver for receiving pharmaceutical waste material. A locking assembly is secured to a fixed surface and actuated from a locked configuration to an unlocked configuration. A lock cylinder of the locking assembly may extend forward of a front wall of a receiver body of the waste receiver to engage a locking feature of the cover in the locked configuration. A cover retention feature may prevent axial decoupling of the cover from the receiver body. An engagement feature is moved to be disengaged from the receiver body, and the receiver body is moved away from the fixed surface to disengage the locking assembly from the cover. The cover is decoupled from the cover retention feature, and coupled with the receiver body to seal the pharmaceutical waste material. The locking assembly may be removed from a lock passageway for disposal of the waste receiver.

Abstract: A sleeve assembly is described for coupling a colonoscope insertion tube to an add-on tube. In some embodiments, the sleeve assembly defines an elongated lumen and comprises an inner sleeve sized to receive an insertion tube of a colonoscope, an outer sleeve encircling the inner sleeve, and one or more add-on tubes positioned between the inner sleeve and the outer sleeve. In some embodiments, at least the inner sleeve is collapsible to fit tightly over a colonoscope insertion tube received within the inner sleeve. In some embodiments, the inner sleeve is coupled to the outer sleeve at one or more locations along the length of the inner sleeve so that collapsing of the inner sleeve brings the outer sleeve radially closer to the inner sleeve, approximating the one or more add-on tubes to a colonoscope insertion tube received within the inner sleeve.

Abstract: A vertical organizational system for use in the operating room during surgery to hold surgical instrumentation is provided. The system includes a vertical support including a height and angle adjustable portion; vertical support assembly, a back panel, a pivoting spine assembly, a base interface member, casters, a base, an interactive user display, a tray shelf, a receptacle container, a primary working shelf, a formed base, a custom sterile drape, an identification system, a telescoping mayo stand, telescoping step stool, a light assembly, a sterile aerosol assembly, an instrument tray attachment device, telescoping cross rail extensions and a ceiling mounted boom assembly. The planogram software is customized and integrated into the rack system to ensure consistently reliable and effective workmanship. The cantilever shelves are detachably attachable from the cross rails and helps maintain the sterile state of the instrumentation trays even if the rest of the rack is not maintained in a sterile state.

Abstract: Packaging for prosthetic heart valves including an assembly for securely retaining a heart valve within a jar and facilitating retrieval therefrom. The assembly includes a packaging sleeve that fits closely within the jar and has a clip structure for securing a valve holder. Contrary to previous designs, in one embodiment the valve holder is directed downward into the jar, and the valve is retained with an inflow end upward. The valve may have flexible leaflets, and a leaflet parting member on the end of the shaft extends through the leaflets and couples with the valve holder. The assembly of the packaging sleeve, valve, and holder can then be removed from the jar and a valve delivery tube connected with the holder, or to the leaflet parting member. The packaging sleeve may be bifurcated into two halves connected at a living hinge to facilitate removal from around the valve/holder subassembly.

Abstract: A breast cavity spacer device, a kit for performing a biopsy and a method of performing a biopsy, such as for use with a percutaneous lumpectomy, is provided. The breast cavity spacer device includes a catheter. A self-sealing balloon member is removably and fluidly coupled on one end of the catheter. An umbrella valve is coupled to the catheter adjacent the balloon member, the umbrella valve being configured to fluid flow into the balloon in response to fluid flow from an end of the catheter opposite the balloon and prevent fluid flow from the balloon when fluid flow from the end of the catheter is stopped.

Abstract: Products, systems and methods are disclosed for lowering the concentrations of at least one of preservatives and fibrils in a liquid insulin composition. One method comprises replacing at least a portion of at least one of phenol and m-cresol with at least one of cyclodextrins, cyclodextrin polymers, cyclodextrin beads, and an ion exchange resin.

Abstract: A syringe assembly includes (1) a syringe barrel defining a chamber; (2) a plunger mounted in the chamber and moveable with respect to the barrel; and (3) a cap assembly containing a cap and an absorbent material is removably attached to the plunger. A strip package includes at least two cap assemblies. Each of the cap assemblies includes a cap holder and an antiseptic cap positioned in the cap holder. The antiseptic cap includes a sidewall defining a chamber and an antiseptic substance within the chamber. A strip extends over at least two cap assemblies. The strip includes a first seal engaged to the cap holder and a second seal engaged to the antiseptic cap.

Abstract: An occlusion assembly and its uses in a REBOA procedure is disclosed. The occlusion assembly includes a single elongate shaft having an inflatable balloon, a proximal neck portion, a distal neck portion. The shaft defines a single lumen through which a wire is positioned for support of the shaft and through which an inflation fluid is also passed to inflate the balloon.

Abstract: A packaging device for a trocar assembly includes a trocar packaging clip having at least two holding structures configured to be detachably secured to the proximal portions of the trocar obturator and the cannula for retention of the trocar obturator and cannula relative to each other. The trocar packaging clip includes an anti-rotation structure configured to engage at least one of the trocar and the cannula to prevent relative rotation thereof.

Abstract: A container comprising a body having an annular side wall on a base, an internal channel within the side wall, and a metal ring disposed within the channel. The container is a flexible material.

Abstract: A container apparatus having at least one containment member is disclosed that may include a bottom and at least one sidewall, an interior and an open end. The container may also include a flange that extends around a free end of the at least one side wall, and a plurality of wall members (or castellations) connected to/formed with/that extend from the flange. The plurality of wall members may be separated by ventilation apertures, with the plurality of wall members and the ventilation apertures extending around the perimeter of the free end. A sealing material, such as a removable film, may extend over the open end to enclose the containment member.

Abstract: Aspects of the disclosure relate to packaging assemblies including a tray having at least one compartment adapted to receive a medical device component or product. The packaging assemblies a barrier film covering the compartment and a lid pivotally attached to the tray; wherein the tray and the lid each include cooperative latching features. The lid defines a recess in which one or more product items can be stored and the packaging assembly further includes a label removably secured over the recess and the sheet of product documentation. Methods of assembling, sterilizing and opening such packaging assemblies are also disclosed.

Abstract: A package for a multi-component medical device is disclosed. The package includes a bottom portion with cavities providing individual access to different components of the medical device, thereby enabling a user to remove components from the package in any order without disturbing the remaining component or components. The package also includes a barrier affixed to the bottom portion for sealing the package.

Abstract: A probe sleeve for holding a probe in various stages of cleanliness with indicators thereto. The probe sleeve comprising an envelope portion, a sealing system, and a plurality of indicator zones. The envelope portion comprising a mouth. The mouth is operative to receive and release the probe. The envelope is operative to hold the probe. The plurality of indicator zones comprise a first indicator zone and a second indicator zone. The plurality of indicator zones display a status indicator related to the state of the probe. The sealing system is configured to selectively close and open the mouth. The first indicator zone is operable to signify that the probe is clean. The second indicator zone is operable to signify that the probe is not clean.