Abstract: A device for use with a uterine tamponade balloon catheter apparatus, such as the Bakri postpartum hemorrhage balloon, is disclosed. The device comprises a stylet comprising a hub at its proximal end. The device is configured to be removably coupled to the tamponade balloon catheter apparatus to aid in the insertion and positioning of the tamponade balloon catheter within the uterine cavity, allowing the balloon to function as intended for the control and management of postpartum hemorrhage and uterine bleeding. Methods of use of the device are also disclosed.

Abstract: The breakaway assembly includes a first breakaway subassembly and a second breakaway subassembly. The subassemblies are configured to connect, which causes bellows sheaths in each subassembly to compress and open pores, allowing fluid to flow through the subassemblies. The subassemblies can be connected to luer tip. The luer tips can be connected to an intravenous (IV) fluid line or other types of lines used in the medical field to move fluids. This allows the movement of fluid from a fluid-holding component to a patient. Unless the subassemblies are locked together, the subassemblies will be disconnected under the correct amount of pressure. This disconnection closes the pores on the subassemblies, which keeps fluid from leaking, and prevents the contamination of the IV line. Luer tips may also be connected to the subassemblies. Some of the luer tips allow for the quick connection of the luer tip to the subassembly through a flange being inserted into a notch or flange acceptor.

Abstract: A connector for medical fluid vessels includes a fluid-seal fitting such as a male plug defining a lumen and mating with a cooperating connector, a mechanical fastener such as a screw thread for mating with the cooperating connector, and an outer housing positioned around the plug to form an annular space. Optionally, a cap can be provided with a fluid-seal fitting such as a male plug for mating with the lumen of the connector. The connector includes one or more vent openings for drainage and air-drying of any residual fluid in the annular space when capped, as well as for breaking a vacuum to prevent fluid backflow and thus ensure more accurate dosing. In some embodiments, the vent openings are provided in the outer housing. And in some embodiments, the vent openings are provided in the cap.

Abstract: A medical fluid coupling for connecting a fluid line to a connection section of a blood treatment apparatus or for connecting to a connecting adapter comprises at least one main body. The main body includes a first latching element with a first section. The first section is designed to be elastically bendable and/or elastically tiltable. The main body may optionally include a second latching element with a second section. At least one of the first latching element and the second latching element comprises a recess for receiving a protrusion of the connection section and/or a protrusion to reach into a recess of the blood treatment apparatus or of the connecting adapter.

Abstract: Described here are devices, systems, and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter and a second catheter, which may comprise one or more fistula-forming elements. The first and second catheters may comprise one or more magnets, which may be used to assist in bringing the first and catheters in closer proximity to facilitate fistula formation. In some variations, the magnet may have a plurality of magnetic domains each characterized by a magnetic flux vector, with the magnetic flux vectors of the magnet passing through a common magnetic origin.

Abstract: Described here are devices, systems, and methods for forming a fistula between two blood vessels. Generally, the systems may comprise a first catheter and a second catheter, which may comprise one or more fistula-forming elements. The first and second catheters may comprise one or more magnets, which may be used to assist in bringing the first and catheters in closer proximity to facilitate fistula formation. In some variations, the magnet may have a plurality of magnetic domains each characterized by a magnetic flux vector, with the magnetic flux vectors of the magnet passing through a common magnetic origin.

Abstract: A pulmonary artery flow restrictor system includes a funnel shaped membrane with a proximal base and a restrictive distal opening which is stretchable to larger sizes. A self-expanding frame is attached to the proximal base of the membrane for securing the membrane within the pulmonary artery.

Abstract: An enteral feeding connector, coupling or syringe tip configured for compatibility with blenderized feeding applications. The connector, coupling or syringe tip has a minimum internal bore dimension greater than the standard ENFit coupling specifications, to provide improved delivery of blenderized food.

Abstract: A tubular fitting for medical fluid lines includes a hollow body within which a male connector and an opposite female connector are coaxially housed. The male connector is coupled in rotation with respect to the body in a direction corresponding to a screwing with a female connector of the line, while it is normally freely rotatable in the unscrewing direction, in the same way as the female connector is coupled in rotation with respect to the body in the direction corresponding to the screwing with a male connector of the line, while it is normally freely rotatable in the unscrewing direction. The male connector and/or the female connector can possibly be locked in rotation with respect to the body in the unscrewing direction, only following a positive command.

Abstract: An implantable system includes a ventricular assist device (VAD), a cuff for attachment to a heart, and a latching mechanism attached to the VAD. The VAD includes an inlet cannula. The cuff defines an outward facing circumferential groove and an opening for the inlet cannula. The cuff includes a plurality of ridges disposed at least partially within the outward facing circumferential groove. The latching mechanism is reconfigurable between an unlatched configuration in which the latching mechanism accommodates insertion of the inlet cannula into the opening and a latched configuration in which the latching mechanism is engaged with the cuff to restrain the position of the inlet cannula relative to the cuff and engaged with at least one of the plurality of ridges to block rotation of the VAD relative to the cuff.

Abstract: In some embodiments, a medical fluid connector is configured to receive an emitter of therapeutic agents to be emitted into a fluid pathway within the connector, the medical fluid connector comprising a proximal female end, an intermediate region, a distal male end, and a fluid pathway extending from the proximal female end, through the intermediate region, to the distal male end. A retaining structure is positioned within the intermediate region. The retaining structure is configured to securely receive an emitter of one or more therapeutic agents in a position and orientation where the fluid pathway is configured to convey fluid moving longitudinally through the fluid pathway directly into a proximal region of the emitter, around one or more lateral surfaces of the emitter, and toward the distal male end.

Abstract: A catheter assembly may include a catheter adapter, which may include a proximal end, a distal end, and a lumen extending between the proximal end and the distal end. The distal end may include a catheter configured to be inserted into vasculature of a patient. The catheter assembly may also include a septum, which may be disposed within the lumen of the catheter adapter. The septum may be secured within the lumen in response to increased pressure by one or more of the following: one or more septum stoppers, a retention disc of a needle assembly, a U-shaped washer, and a conical washer.

Abstract: A rotatable fluid flow connector including a base element and a rotatable element, the rotatable element being non-removably but rotatably connected to the base element for rotation about a common axis. For use in a rotatable fluid flow connector including a base element, a rotatable element arranged for locking engagement with the base element and rotation with respect thereto about a common axis, the rotatable element being formed with a flange having at least one flange surface extending in a plane which is perpendicular to the common axis.

Abstract: A catheter coupling has a tubing and two jaws extending in the longitudinal direction of the tubing which form a channel having an orifice to accommodate an end section of a catheter when the jaws abut against each other. The jaws are interconnected at a respective jaw end via a jaw joint having a joint axis extending transversely to the tubing. The other jaw end includes a snap-in locking member and a counter snap-in locking member, respectively, interacting therewith to form a snap-in locking arrangement. In the engagement position, the tubing is deformed by at least one jaw deformation component to securely accommodate the catheter. The coupling has at least one inspection window that allows a stop in the tubing for the end section of the catheter to be visually inspected to prevent an end section of the catheter from being introduced into the tubing if it is too short.

Abstract: A catheter suitable for delivering an electric current to the body, in particular a catheter having electrodes that can be positioned independently of the main elongate shaft of the catheter. More particularly the catheters include a movable sleeve that incorporates the electrodes. A movable sleeve includes one or more electrodes and advances in the construction of the electrodes and related components is disclosed. Methods for positioning electrodes at a treatment site in the body for diagnostic or therapeutic applications, particularly electrical pharyngeal stimulation are also disclosed.

Abstract: A set of instruments configured to deliver a therapy to a bone can include a cannulated syringe. The cannulated syringe can extend along a longitudinal axis between a proximal and a distal end. The cannulated syringe can have an inner tube and an outer tube that are interconnected at the distal end as a single fixed unit. A first cannulation can be formed along the longitudinal axis of the cannulated syringe within the inner tube and a second cannulation can be formed within an annular space between the inner and outer tubes. The outer tube can define an opening through a sidewall thereof. The cannulated syringe can be closed from fluid communication between the inner and outer tubes.

Abstract: Various embodiments of the present invention are directed to equalizing pressure in a reservoir containing fluidic media, possibly due to imperfect installation of the reservoir or an external influence such as an altitude or a temperature change. In various embodiments, fluidic media may be expelled from the reservoir through a needle and contained in an interior volume of a pierceable member before the needle pierces the pierceable member to establish a flow path to a user. In other embodiments, fluidic media may be expelled through a port of the reservoir into a chamber or to the outside environment. In further embodiments, fluidic media may be expelled through a channel in a plunger head and out a passage in the reservoir when the channel and passage are aligned. In other embodiments, fluidic media may be expelled through a valve, and the valve may be pierceable by a needle to establish a flow path to the user.

Abstract: A catheter includes a tissue-removing element and a tissue-containment chamber configured to receive tissue removed by the tissue-removing element. The tissue-containment chamber has a tissue-removing opening for use in removing tissue from the chamber. A closure component is associated with the tissue-removing opening for selectively opening and closing the opening.

Abstract: A medical device may include a device handle having a diverter block non-movably disposed within an interior cavity of the handle, the diverter block including at least one lumen extending longitudinally therethrough and a distal mounting portion. A delivery sheath may be coupled to the device handle. A catheter assembly may extend distally from the device handle within the delivery sheath. The catheter assembly may include a multi-lumen polymeric shaft coupled to the diverter block, and a metallic hypotube section disposed about and fixedly attached to a proximal end of the shaft. The hypotube section may releasably lock the shaft to the diverter block in fluid communication with the at least one lumen of the diverter block. The delivery sheath may be axially translatable relative to the device handle and the catheter assembly may be fixed in position relative to the device handle.

Abstract: A needle assembly has a needle hub that has a body to which are formed two plates at opposite sides thereof in a parallel relationship. The plates have respective upper edges and lower edges that lie substantially along respective planes, so that the needle hub may be stably placed onto a surface by means of the respective edges. A partition is formed orthogonally proximate to the front ends of the parallel plates. The partition and the parallel plates together provide upper and lower three point stable supports for the needle hub. A notch at the partition provides a guided line of sight to the tip of the needle for the user. The connector at the proximal portion of the needle hub has a non-conventional configuration that allows it to mate only with a counterpart special connector of a fluid conveying device that has a complementary non-conventional configuration.

Abstract: The invention relates to a device for sterile connection of single-use medical articles, consisting of an outlet connector (1), which has an outlet cylinder (4) that is equipped with a seal (6) and that is closed at one of its ends. A union nut (8) is provided on the outlet connector (1), and of an inlet connector (2), which can be connected with the outlet connector (1) and which is closed at one of its ends. The outlet connector (1) and the inlet connector (2) are respectively closed at their ends turned toward one another with a perforation seal (9, 9?).

Abstract: A luer lock adaptor including a housing defining an axis, an internal luer lock element having a threading, the internal luer lock element being located internally of the housing and being rotatably mounted thereto for rotation about the axis relative to the housing, in a manner which permits rotation of the luer lock element relative to the housing in a first rotation direction about the axis and limits rotation of the luer lock element relative to the housing in a second rotation direction about the axis, opposite to the first rotation direction, whereby the location of the internal luer lock element internally of the housing prevents manual access to the internal luer lock element for limiting rotation thereof in the first rotation direction.

Abstract: The invention relates to a liquid extraction module (1) for extracting liquid from a liquid tank, in particular of an exhaust-gas aftertreatment system of a motor vehicle, having an insert part (2) which is produced at least substantially from plastic and which has at least one extraction opening (5) and at least one plug connector (14) for the electrical contacting of an electrical consumer (10, 7) of the liquid extraction module (1). It is provided that a housing (16) of the plug connector (14) is formed separately and has at least one encapsulated undercut (22, 32) for fastening to the insert part (2).

Abstract: An injection site for medical lines includes a tubular body made of molded plastic material within which an elastic element made of thermoplastic material is overmolded on an enlarged end of the tubular body. The enlarged end delimits an inner annular flange and is formed with at least one radial through-hole through which the elastic element is overmolded in order to rest axially against the inner annular flange and fill the radial through-hole with an appendage.

Abstract: A needleless connector module comprises: a sleeve tube, an elastic valve, a flow guiding unit and an extension unit. The elastic valve sleeves a guiding tube of the flow guiding unit. A hollow shoulder portion of the elastic valve abuts a slanted retaining wall of the sleeve tube. Under a first usage condition, the hollow head portion of the elastic valve encloses the guiding tube narrow portion, hiding the first guiding opening in the airtight seam. Under a second usage condition, an injection tube presses the top face of the elastic valve, a hollow head portion of the elastic valve presses downward, driving the valve inner wall to abut a waist platform formed on the guiding tube, such that the first guiding opening is exposed outside the airtight seam, and such that the first guiding opening is connected to an injection opening of the injection tube.

Abstract: In one general aspect, an implant includes a cuff defining an opening configured to receive a cannula coupled to a heart pump. The implant includes a coupling mechanism having a first position and a second position, the cuff being uncoupled from the cannula in the first position and the coupling mechanism coupling the cuff to the cannula in the second position. The implant includes a locking mechanism configured to secure the coupling mechanism in the second position, and the locking mechanism is configured to be moved to a locked position after the coupling mechanism is in the second position.

Abstract: A device for securing an oral tube, such as an endotracheal tube, positioned in a patient's trachea includes a support surface, such as an open channel, for supporting the tube. First and second arms extend outwardly from the open channel. The first and second arms form an arch having first and second ends. Bite blocks are provided adjacent the first and second arch ends for contacting the patient's teeth or gums, and a receiver for securing the tube against the support surface is likewise provided. A flexible member having first and second ends for looping around the patient's nasal septum is likewise provided. At least one of the ends of the flexible member is received in a retainer and assists in securing the device in position.

Abstract: A surgical utility connector is detectable by a surgical utility supplying device to indicate connection with the surgical utility supplying device. The surgical utility connector includes a first connecting region, a second connecting region, and a detection region between the first connecting region and the second connecting region. A utility channel may pass a utility from the surgical utility supplying device. The utility channel may extend through the first connecting region, the detection region, and the second connecting region. The surgical utility connector also may include a magnetic element disposed in the detection region and surrounding the utility channel. The magnetic element may have a field detectable by the surgical utility supplying device when the surgical utility connector is connected to the surgical utility supplying device.

Abstract: A multi-section tubular member including a sleeve surrounding and bridging a joint between a first section and a second section of the tubular member, and a method of forming a multi-section tubular member are disclosed. A polymeric sleeve may extend over a portion of the first section and an adjoining portion of the second section. A length of heat shrink tubing may be placed over the sleeve and heated, thereby compressing the heat shrink tubing around the sleeve. The sleeve may then be thermally bonded to each of the first section and the second section. The heat shrink tubing may then be removed, leaving the sleeve securely joining the first section and the second section to form a multi-section tubular member.

Abstract: A guide is used for the selective catheterism of anatomic structures and for placing therapeutic instruments.

Abstract: A connector for a fluid handling system includes a body defining a plurality of internal passages that connect single-lumen tubes to lumens of a multi-lumen tube. Openings located along an internal edge of connector provide fluid communication between the internal passages and openings located along a curved outer surface of the multi-lumen tube.

Abstract: The present invention provides an adaptor that is suitable for attachment to an endoscopic device for delivery of a secondary gas. The adaptor can comprise a substantially cylindrical body with a two, opposing closed ends, two fluid transport channels extending through the cylindrical body and opening at the closed ends, and an inlet port extending outward from the cylindrical body and being in fluid connection with one of the fluid transport channels. The adaptor may be used in endoscopy methods and is particularly useful for adding a secondary gas source in an endoscopy procedure.

Abstract: A rinsing line for discharging a rinsing fluid out of a medical technical functional device having been rinsed by means of the rinsing fluid is described, in which the rinsing line is, on the one side, connected, provided or intended for being connected with a section of the medical technical functional device and in which the rinsing line is, on the other side, connected with, provided or intended for being connected with a fluid supplying device for supplying a medical fluid into the medical technical functional device. A medical technical functional device, a medical technical treatment apparatus, a method and a control unit are also described.

Abstract: Various embodiments of the present invention are directed to equalizing pressure in a reservoir containing fluidic media, possibly due to imperfect installation of the reservoir or an external influence such as an altitude or a temperature change. In various embodiments, fluidic media may be expelled from the reservoir through a needle and contained in an interior volume of a pierceable member before the needle pierces the pierceable member to establish a flow path to a user. In other embodiments, fluidic media may be expelled through a port of the reservoir into a chamber or to the outside environment. In further embodiments, fluidic media may be expelled through a channel in a plunger head and out a passage in the reservoir when the channel and passage are aligned. In other embodiments, fluidic media may be expelled through a valve, and the valve may be pierceable by a needle to establish a flow path to the user.

Abstract: A catheter assembly (10) having a catheter (12) with lumens (20a,20b), extension tubes (14a,14b) and a hub (16). Distal ends (36) of the extension tubes and the proximal end (24) of the catheter are secured in and to the hub. Fittings (50) are first affixed in the distal ends of the extension tubes and have annular collars (56) that are embedded in the hub when the hub is molded over the distal ends of the extension tubes during manufacturing. An array of annular barbs (60) secure the cylindrical portion (52) of each fitting in the respective extension tube distal end (36).

Abstract: The present invention discloses a catheter instrument (1000) comprising a needle tip shielding device (100), a needle (303), a needle carrying unit, and a catheter unit, said catheter unit comprising a catheter hub (200) and a catheter (201), and said needle tip shielding device (100) and said catheter hub (200) being separable from one another, wherein said needle tip shielding device (100) is kept in contact with said catheter unit upon withdrawal of said needle (303) via at least one interface surface between said needle tip shielding device (100) and said catheter unit, and wherein said at least one interface surface of said needle tip shielding device (100) being at least partly of a first polymeric material and said at least one interface surface of said catheter unit being at least partly of a second polymeric material.

Abstract: A medical connector for minimizing leakage of fluids during connection and disconnection is described. The medical connector includes a body having an inlet port, at least one outlet port adjacent to a male luer portion of the body, and a fluid path between the inlet port and the at least one outlet ports. A retractable seal adjacent to the male luer portion of the body and blocks the outlet ports of the body when the male luer portion of the medical connect is in a disconnected state. The retractable seal is positioned on the body such that it is moved away from the outlet ports upon insertion of the male luer portion of the medical connector into a medical access device thereby unblocking the outlet ports and creating a fluid path through the medical connector.

Abstract: An adapter for an endovascular device and a catheter steering device are provided. The adapter for an endovascular device includes a body, a conductive metal ring and a conductive wire. The body includes a first open end, a second open end, a central lumen having a substantially cylindrical surface extending from the first open end to the second open end, and a channel extending from the central lumen to an external opening. The conductive metal ring is attached to the surface of the central lumen, and the conductive wire is coupled to the conductive metal ring and extends through the channel and the external opening. The steering device for a catheter that has a plurality of lumens with spaced distal openings includes a stylet for disposition within one of the plurality of lumens, and a steering member for disposition within a different one of the plurality of lumens.

Abstract: The present disclosure relates to a coupling, in particular a hub (2 a-i), with a base body (23 a-i) having a proximal end (24 a-i), embodied as a connecting region (25 a-i) for an applicator (26 a-i), and a distal end (27 a-i), embodied as connecting region (28 a-i) for a delivery device (29 a-i) with a tubular member (30 a-i) for delivering a medical device (31 a-1) into a part of an animal or human body, and having a recess (9 a-i) extending between the proximal end (24 a-i) and the distal end (27 a-i). It is provided that the recess (9 a-i) is positioned eccentrically from an outer diameter (20 a-i) of the base body (23 a-i) and a central axis (18 a-i) of the recess (9 a-i) is nonparallel in respect to a central axis (32 a-i) of the outer diameter (20 a-i) of the base body (23 a-i).

Abstract: Disclosed herein is a fluid infusion device of the type that delivers medication fluid to the body of a patient. The device includes or cooperates with a fluid reservoir, and the device has a sealing assembly to receive and form a fluid seal with the fluid reservoir. A retractable sealing element surrounding a hollow fluid delivery needle may be used to seal a port of the fluid reservoir. The port may include a pressure vent that is sealed by the retractable sealing element. In one variation, the reservoir includes a moving valve sleeve that holds a septum. The septum moves to allow the reservoir to vent, and to form a seal with the port when the needle pierces the septum. In another variation, the device includes a needleless sealing assembly. In yet other variations, the device uses a needled fluid reservoir.

Abstract: A luer lock connector is disclosed. The luer lock connector includes a connector body having a distal end, a proximal end, and a gripping portion between the distal end and the proximal end. A substantially flexible material is disposed on at least the outer surface of the gripping portion of the connector body. An intravenous line is coupled to the distal end of the connector body. A luer connector fitting is disposed on the proximal end of the body, the luer connector having an outer diameter less than a maximum exterior thickness of the gripping portion of the connector body.

Abstract: Methods and systems for determining the concentration of one or more analytes from a sample such as blood or plasma are described. The systems described herein can be configured to withdraw a certain volume of sample from a source of bodily fluid, direct a first portion of the withdrawn sample to an analyte monitoring system and return a second portion of the sample to the patient. The analyte monitoring system can be connected to the source of bodily fluid via a connector that is configured to maintain uniform velocity across the connector and reduce the dead space volume.

Abstract: Cap and cleaning devices antiseptically maintain patient fluid line access valves to minimize the risk of infection via catheters. The devices have a cap that may contain a dry pad impregnated with an antimicrobial agent. The cap covers the access portion of the access valve when not in use. The devices have a hood that contains a wet pad impregnated with a cleaning solution and, optionally, an antimicrobial agent. The wet pad cleans the access portion of the access valve prior to and optionally, after the access valve is utilized to access the patient fluid line.

Abstract: The present invention provides for a safety device and methods of using a safety device for use with a medical implement having a body with an inlet end portion, the safety device comprises a bracket for mounting on the body of the medical implement; a cap supported by the bracket and sized to fit over and seal the inlet end portion of the medical implement in a safety position wherein the cap covers the medical implement; an elongate shaft having a longitudinal axis, the shaft being secured to the cap and being slidably and pivotally supported by the bracket so that the cap can be raised away from the inlet end portion of the medical implement and be pivoted about the longitudinal axis of the shaft away from the inlet end portion; and a biasing means for biasing the cap to the safety position.

Abstract: In one general aspect, an implant includes a cuff defining an opening configured to receive a cannula coupled to a heart pump. The implant includes a coupling mechanism having a first position and a second position, the cuff being uncoupled from the cannula in the first position and the coupling mechanism coupling the cuff to the cannula in the second position. The implant includes a locking mechanism configured to secure the coupling mechanism in the second position, and the locking mechanism is configured to be moved to a locked position after the coupling mechanism is in the second position.

Abstract: A motor-driven compressor includes a compression mechanism compressing and discharging fluid, an electric motor driving the compression mechanism, a drive circuit controlling the electric motor, a drive circuit chamber accommodating the drive circuit and a hermetic sealing inspection port that allows the drive circuit chamber to be in communication with the outside thereof. The hermetic sealing inspection port includes a valve opening and closing the hermetic sealing inspection port. The drive circuit chamber can be pressurized or depressurized through the hermetic sealing inspection port. The hermetic sealing inspection is conducted by connecting an outside fluid machine to the hermetic sealing inspection port through a detachable tube. The fluid machine is operated so as to depressurize or pressurize the drive circuit chamber through the hermetic sealing inspection port. The pressure in the drive circuit chamber is measured by a pressure meter provided in the tube.

Abstract: A catheter adapter assembly includes an adapter body and a slider body. The adapter body includes a distal end portion configured to receive a catheter, a coupling disposed on the distal end portion, and a fitting on the proximal end portion. The slider body is disposed about the adapter body and axially slides along the adapter body. The slider body includes a release, a latch disposed at a distal end of the release, and a flexing portion disposed at a proximal end of the release. The slider body also includes compression element that compresses the tubular catheter receiver in response engagement of the latch and the coupling. A catheter adapter system comprising the catheter adapter assembly and a nest that holds the catheter adapter assembly is also disclosed.

Abstract: A fluid reservoir for use with a fluid infusion device is provided. The fluid reservoir can include a first portion having a first end and a second end. The first end can include an alignment feature and a delivery port. The fluid reservoir can include a second portion coupled to the second end of the first portion, with a portion of the second portion movable within the first portion to advance a fluid out of the delivery port. The fluid reservoir can also include a reservoir defined between the first portion and the second portion that receives the fluid.

Abstract: Apparatus is described for facilitating delivery of a substance through skin (70) of a subject. A skin preparation device (50), and a patch assembly (20) that comprises the substance and is magnetically couplable to the skin preparation device, are described. Other embodiments are also described.

Abstract: A universal introducer adapter which can be inserted into a pre-placed introducer of arbitrary dimensions eliminates the need to replace or remove the introducer. The adapter includes a distal portion with a retainer in the form of a soft elastic material.