Abstract: A tamper-resistant closure for a medical injection device such as a syringe includes a cap having both a blind bore sized to receive and seat tightly against the syringe tip, to prevent material from entering or being withdrawn from the device. The cap has a threaded connection to the syringe tip, and is entirely covered by a loose-fitting shield having a one-way drive mechanism which prevents the cap from being unscrewed from the device while the shield is in place. The shield has at least one internal, frangible tang protruding obliquely into the envelope of the cap, so that the shield and cap can be easily assembled, but cannot thereafter be disassembled without breaking the tang and thus providing an indication of tampering.

Abstract: A self-capping syringe is provided, which consists of a barrel having a first end and a second end. A finger flange is on the first end and a needle hub is on the second end of the barrel. A plunger slides within the barrel and extends from the finger flange, while a thumb rest is on an outer end of the plunger. A needle extends axially outward from the needle hub on the second end of the barrel. A protective cap is also provided. A mechanism is for allowing the protective cap to twist upon the barrel from a retracted position that exposes the needle to an extended position which covers the needle. A structure is for locking the protective cap in the extended position after use, so as to prevent an accidental needle stick before disposal.

Abstract: A syringe is arranged with a frangible connection between a conical needle head mounting a needle member to permit removal of the head and associated needle member permitting projection of the needle into the syringe body subsequent to its use. A modification of the invention includes a container to receive used needle bodies, with indicator dye contained within the capsule within the needle body that is ruptured upon insertion of the needle therewithin for indication of a used needle within a storage container.

Abstract: A ventilation cap for a flashback chamber is formed of a hollow elongate cylindrical body of polymeric material and includes a proximal opening which is blocked by a venting material such as a hydrophobic filter, and a distal opening which is sized to allow an extension of the flashback chamber to be inserted therein for airtight connection therewith. The elongate body of the ventilation cap has a tear strip formed therein by a pair of generally parallel score lines. The cap is affixed to the flashback chamber so as to allow air to pass from the flashback chamber through the vent as blood fills the flashback chamber, while preventing blood from passing through the vent. When it is desired to attach other apparatus to the extension of the flashback chamber, the tear strip, which may have a pull tab integrally formed therewith, is torn away from the elongate body to destroy the airtight seal between the flashback extension and the cap.

Abstract: The syringe includes a barrel, a plunger, and an adapter for mounting the needle in the distal end of the barrel. The adapter includes a protrusion projecting away from the needle end and into the barrel defining an annular space between the barrel and the protrusion. The plunger and protrusion have complementary surfaces whereby the plunger may grip the adapter for removal of the adapter into the interior of the barrel after use. The adapter includes vent passages communicating between the central passage through the adapter and the annular space whereby air can be vented from the barrel after receiving fluid within the barrel and prior to injection. Thus, the syringe may be oriented in a vertical position needle end uppermost with the vent passages forming the most superior portion of the barrel interior whereby air may be vented.

Abstract: A nonreusable syringe is provided having an automatically retracting hypodermic needle to prevent accidental injury after injection or undesirable reuse of the syringe. The needle is retracted by a spring located behind the syringe piston and disposed to prevent reextension of the needle after use. A locking mechanism holds the needle in position for injection. The piston includes means to release the locking mechanism as injection is completed to automatically retract the needle into the syringe. The syringe tip seal is not in frictional contact with the needle, eliminating drag on the needle during retraction. A safety indicator is provided to indicate previous use.

Abstract: A hypodermic syringe assembly has a hollow body having a neck centered on an axis, an elastomeric plug fitted in the neck and having an end projecting axially forward from the neck, a stiffening sleeve fitted over the plug and neck and having a collar fitting around the projecting plug end and itself projecting axially therepast, an elastomeric stopper fitted into the collar, and a protective cap fitted over the plug, sleeve, and stopper. A destructible connection between the cap and the sleeve retains the cap in place on the body over the plug, sleeve, and stopper. This cap is therefore only removable from the body by destruction of the connection. The protective cap is basically cylindrical and centered on the axis and has a front end wall generally transverse of the axis and an opposite rear end edge and the destructible connection extends annularly between the end edge of the cap and the sleeve.

Abstract: A medical instrument whose distal end is inserted into a body cavity of a subject in cooperation with a treating unit, comprises an insertion section including a distal end inserted into the body cavity and having a first opening exposed there, a proximal base end located outside the body of the subject, and a channel provided in the insertion section and extending from the proximal base end toward the first opening, an operation section connected to the proximal base end and having a second opening leading to the channel, a mount piece provided around the second opening. A valve is provided on the mount piece including a body having a slit adapted to be opened when the treating unit is inserted into the channel and closed when it is withdrawn from the channel and an annular groove detachably fitted on the mount piece, and a thin-walled portion for destroying the valve when the valve is removed from the mount piece.

Abstract: An indwelling device for passing fluids into or out of the body includes an inflatable cuff for lodging the device within a body passage. The inflatable cuff is inflated with a fluid such as saline. Prior to the inflation process a dye dispersant material such as methylene blue is incorporated in dry form within the inflation cuff and/or within an inflation lumen which leads to the inflation cuff and/or within a pilot balloon which is accessed by a source of saline fluid. Thus, as the cuff is inflated with saline, the methylene blue dissolves and disperses in the saline enabling the saline to take on the color of the methylene blue dye. A buffer is combined with the methylene blue to enhance the dispersal of the dye in the saline. Potential piercing of the expanded cuff after it is filled with methylene blue provides a blue stain or leak that is easily recognized as a sign of damage to the cuff. Correction steps can thus be taken to repair or replace the endotracheal tube as soon as the leak is recognized.

Abstract: An assembly for the administering of liquid, such as medicines, saline solutions, etc. intravenously to a patient incorporating a sterile, closed system specifically designed for set-up and use by a patient in a domestic environment and in situations where the patient administers fluid to himself with a minimum of medical personnel supervision or aid.

Abstract: A syringe having tamper evidence features includes a barrel having a chamber for retaining fluid, an open proximal end, and a distal end having a passsageway therethrough in fluid communication with the chamber. A needle shield having a longitudinal axis, a distal end and an open proximal end slidably engages the distal end of the barrel covering the passageway. The shield includes an outwardly projecting shield lug having a cam surface. A collar having an annular side wall, an open proximal end and a distal end having an aperture therethrough, is adjacent to the distal end of the barrel with the needle shield projecting distally through the aperture. The apreture is sized so that the proximal end of the needle shield cannot pass therethrough. The collar includes an inwardly projecting lug having a follower surface for contacting the cam surface.

Abstract: Methods of labeling and novel labels for needle syringes and medication vials are provided, involving fool-proof transfer of medication information labels peelable from the vial and applied as a syringe label tag or flag remote from the syringe barrel calibrations and in no way impeding physical syringe operation.

Abstract: An assembly of a tube having a breakaway plug member mounted on one opening thereof is provided. The plug member has an open end and a closed end, and includes on its inner surface a first inner-wall portion extending from the open end toward the closed end a predetermined distance which is fixedly secured to the one open end of said tubular body, and a second inner-wall portion defining a space therein which extends from the first inner-wall portion to the closed end. The plug member also includes on its outer surface a thin-walled frangible portion located on or radially outside the second inner-wall portion which is breakable to allow separation of the plug member from the tubular body. The one open end of the tubular body extends in said space beyond the thin-walled frangible portion toward the closed end of the plug member.

Abstract: A container for hypodermic syringes which provides a first, tamper-indicating sealed position for containing a sterilized syringe and a seocnd, lockingly closed position for storing and safely disposing of a used syringe is disclosed. The container includes an elongated hollow plastic tube having an integral end wall closing one end. The opposite open end of the tube flares out to form an enlarged cylindrical boss section. A concave plastic cap fits snugly over rear annular beads projecting readially outwards from the rear portion of the outer cylindrical wall of the boss. Ultrasonic welds between the outer circumferential surface of the rear annular beads, and the inner cylindrical surface of the cap are breakable by twisting the cap relative to the tube providing an audible and tactile indication that the container has not previously been opened. The cap has one or more axially disposed resilient tabs, each tab formed between a pair of slots extending axially inwards from the annular end wall of the cap.

Abstract: A port and closure assembly is provided. The closure includes a cap that cooperates with the port to produce a friction fit. The cap and port are hermetically sealed together by a coating. The coating provides a method of determining if the closure has been opened.

Abstract: A pair of medical tube connectors are interconnected in fluid tight relation. A tamper-evident indicator of breakable material, such as paper, has a pair of strips respectively encircling said connectors, and at least one breakable strip having a width substantially less than the circumference of the tube connectors extending between the strips to provide an indication if the connectors have been separated.

Abstract: A tamper evident injection syringe of the disposable type is described having a container for storage of the material to be injected, means for expelling the material, an interference collar at one end of the container and a flange attached to the expelling means that is close fitting to the internal wall of the container and having a dimension greater than the interference collar such that the flange cannot pass through the interference means thereby preventing removal of the expelling means and the contents of the syringe. In addition a needle nub is described that permits connection of a needle or catheter and the connection of a tamper evident sealing cap that is easily removable yet when removed cannot be replaced without the removal being evident.

Abstract: A one-piece sealed disposable enema unit with a lubricated rectal tip is disclosed. The rectal tip of the unit is sealed with a break-off tab. Attached to the tab is a sleeve which covers the exterior of the rectal tip and prevents contamination of the lubricant. Before use, the break-off tab must be twisted off and the tab with the attached sleeve removed. Therefore, the unit is tamper proof and security of the contents is insured.

Abstract: A protective safety container for encasing toxic drug filled glass vials is disclosed. The container includes a molded plastic body that is shaped to conform to the shape of a vial to be protected. A plurality of spaced longitudinal ribs are formed on the inner surface of the container body that act to engage the vial and hold it firmly in position, and also form a cushioning air space between the vial and the container. A molded plastic annular base is adapted to be snap fitted into the body such that the vial cannot be easily removed once it is secured within the container. Disposed in the top of the container is a small aperture having a frangible disk disposed therein. The disk may be removed so that a hypodermic needle may be inserted into a stopper in the vial to withdraw the vial's contents. The aperture is too small, however, to permit removal of the stopper itself.

Abstract: A unit is provided comprising a filter assembly, a cap and connector assembly to substantially reduce the risk of contaminants entering the flow of material delivered to a patient. The cap and connector assembly portion protects an administration kit from contamination during the priming of the kit. A first portion of the cap closes off the material flow route through the connector, but can be removed by tearing it away from the second portion at a weak area, opening the flow route and allowing the administration kit to be primed. As the system is primed, the second portion of the cap protects the outer surface of the connector. After the administration set has been primed, the second portion of the cap is removed, exposing the outer walls of the connector for mating with a complementary connector. The housing includes three ports for material flow.

Abstract: A visual (as opposed to mechanical or electronic) method for detecting the state of dehydration (or hydration) of a biomedical hydrogel is disclosed. The method contemplates incorporating a pH sensitive indicator into the hydrogel as it is prepared and applying the hydrogel to the skin-contacting surface of a biomedical device such as an electrode. Shortly before the biomedical device is to be used, the color of the hydrogel on the device is visually compared with its freshly-prepared color to determine the approximate state of dehydration of the gel.

Abstract: A tamper discouraging device in a liquid drainage system comprising, an elastic catheter having an elongated shaft, a connector adjacent a proximal end of the catheter, and a drainage lumen extending through a major portion of the catheter and the connector. The device has a hollow drainage tube having a hollow adapter at an upstream end of the drainage tube, with the adapter being received in the catheter connector. The device has a circumferential band being heat shrunk against the catheter over the connector and adapter.

Abstract: A tamper-evident band for a liquid drainage system comprising an elastic catheter having an elongated shaft, a connector adjacent the proximal end of the catheter, and a drainage lumen extending through a major portion of the catheter and the connector. The tamper-evident band comprises elastomeric annular band of stepped diameter which is fit over the juncture between the connector and the proximal end of the catheter. The band has a slot longitudinally arranged on one outer peripheral portion of the band. It also has a semi-circumferential tear tab disposed on one end thereof. To separate the connector from the proximal end of the catheter, the band must be broken. The tab may be pulled and the band separated along its longitudinal slot. A small ring comprising the remaining stepped portion of the band remains on the adapter after the tab has been pulled, the slot fractured and the top band portion removed.

Abstract: An apparatus and method are shown for eliminating mistakes during plasmapheresis procedures in returning red blood cells to a correct donor. In the procedure, a portion of the return blood flow line is rendered inoperative by a lock device. A key, unique to the donor, is attached to the blood collection bag prior to the centrifuging operation which separates the blood into plasma and red blood cells. After the centrifuge operation, flow between the collection bag and the donor can only be established by utilizing the unique key in the correct lock box.

Abstract: A stop member for a device such as a syringe is inaccessibly disposed in a sleeve member. The ring member is also disposed about a portion of the stop member and in the sleeve member. The ring member is connected to the inside of the sleeve member by means of a frangible connection. When the sleeve member is twisted. the sleeve member and its connected ring member freely rotate about a portion of the stop member at the end of the syringe. When the sleeve member is axially pulled off the end of the syringe, the frangible connection breaks, and the sleeve member is removed, leaving the ring member and stop member disposed on the end of the syringe thereby indicating that the prefilled syringe has been tampered with.

Abstract: The present invention provides a medical needle assembly comprising in part a hub and a protector, each discrete from the other and having a lumen passing continuously therethrough. A hollow needle is enclosed within the continuous lumens and fixed to the base of the protector. A thin-walled weak point for separation of the hub and protector is provided near to the periphery of the area of hub and protector attachment. The hub and protector are attached using a solvent capable of dissolving the hub and protector materials, or an adhesive, the use of a plasticized vinyl chloride polymer paste resin being especially desirable. The present invention also provides a medical device in which the above medical needle assembly is incorporated in, and forms part of, a tubing line connected to a container holding blood.

Abstract: The electric heating element in an apparatus for sterilely cutting and welding together a pair of thermoplastic tubes incorporates within the heating element a fusible signal means connected in parallel electrical circuit with the resistor of the heating element for indicating previous use of the heating element. The fusible signal means is capable when intact of providing a signal to a microprocessor controlling operation of the apparatus indicative of previous nonuse of the heating element and is automatically destructed upon energization of the heating element resistor during the first use of the heating element so as to be incapable of providing such nonuse signal upon a subsequent energization. If the nonuse signal is not generated, e.g., the heating element has been previously used, the microprocessor is programmed to reject the heating element, thereby eliminating risks resulting from reusing the heating element.

Abstract: A pierceable port for injecting or withdrawing a fluid through a hollow needle inserted into a container. The port has a covering film securing a sterile pad of resealable material to a wall of the container having a portion pierceable by a needle. A tear strip is heat welded to the cover so as to form a removable tab comprised of a welded tear strip section, a welded cover section and an unwelded lap forming a grip for removing the tab. The tab is connected to an unwelded portion of the cover by a tear joint of substantially less tear strength than either the tab or the unwelded cover portion. The cover and the base member define a chamber for maintaining the sterility of the pad until the tab is removed to expose a sterile portion of the pad for insertion of the needle. A method for making the port is described.

Abstract: A tamper discouraging system comprising, a catheter having an elongated shaft and a hollow connector at a proximal end of the shaft. The system has a drainage tube having an adapter at an upstream end of the drainage tube, with the adapter being received in the connector. The system has a first semi-annular shell for placement over the connector, and a second semi-annular shell for placement over the connector. The system has a hinge connecting one end of the first shell to one end of the second shell, and a locking device for locking the other end of the first shell to the other end of the second shell.

Abstract: An improved additive transfer device for storing and subsequently transferring a fluid material from an additive container to a rigid or semirigid solution container having an exposed closure. The improved additive transfer device is mounted on the additive container and includes a closure assembly fabricated from three components; a pierceable stopper, a slidable piercing pin and a hood member. The closure assembly is adapted to be positioned on the solution container. The two ended slidable piercing pin is disposed in a central opening in the pierceable stopper so that one end will pierce a diaphragm contained in the pierceable stopper. Resistance elements are provided between the slidable piercing pin and the central opening in the pierceable stopper to hold the slidable piercing pin away from the diaphragm in the pierceable stopper in one position and allow the slidable piercing pin to pierce the diaphragm and retain it within the central opening in a second position.

Abstract: A one-piece sealed disposable enema unit with a lubricated rectal tip is disclosed. The rectal tip of the unit is sealed with a break-off tab. Attached to the tab is a sleeve which covers the exterior of the the rectal tip and prevents contamination of the lubricant. Before use, the break-off tab must be twisted off and the tab with the attached sleeve removed. Therefore, the unit is tamper proof and security of the contents is insured.

Abstract: This invention pertains to a tamper-proof sealing cap for a syringe. The cap is made of a partially rubber-like flexible material so that it may be partially deformed from its preselected shape. At least one of its members is preformed into a shape which prevents the re-insertion of the syringe after it has been removed.

Abstract: Instances have been discovered in which a person has inserted the needle of a first hypodermic syringe through the soft rubber drive piston of a second hypodermic syringe to aspirate some of the narcotic fluid from the second syringe into the first syringe. To prevent this mode of pilfering, an impenetrable barrier is included in the second syringe to prevent the insertion of the needle of the first syringe. In the present invention, the impenetrable barrier is the head of a screw that extends through the drive piston for attaching the actuating rod used in moving the drive piston. In accordance with the present invention, the diameter of the head of the screw differs from the diameter of the tubular member by an amount not exceeding the diameter of the smallest needle that would normally be used for pilfering, namely 0.018 inches.

Abstract: An assembly for supporting a cannula comprises a hub which supports the cannula and which includes a post portion which concentrically surrounds a section of the cannula adjacent to the hub. The assembly also includes a cover which is attachable to the post portion of the hub to enclose the cannula. The cover and post portion are coupled together by a "tamper-proof" connection which normally resists removal of the cover, and thereby attests to the sterile integrity of the needle. The connection can be broken in response to the deliberate application of a predetermined rotational force by the user upon the cover and cannot thereafter be recreated, thereby serving as an outward indication that the sterile integrity of the cannula has been compromised. Both the post portion and the cover remain physically intact, despite the breakage of the connection, to permit return of the cover when desired.

Abstract: A container (34) includes first and second chambers (40, 42) for the storage of two substances (44, 46) such as medical liquids. The chambers are separated by a chamber-communicating assembly (61) which is selectively opened by an operator for mixture of the two substances and delivery to a patient. A leak detection compartment (62) encloses the assembly (61) between the two chambers, including a periperhal channel (76) and ridges (80) on the assembly (61).When seal integrity between the container wall sheets (36, 38) and the assembly (61) is less than complete, the leak detection compartment both prevents liquid in one chamber from entering the other through the leak pathway and also assures detection of the leak during the manufacturing operation.

Abstract: The invention relates to a disposable syringe comprising a barrel which has on its front end a needle connection with injection needle and needle guard. The syringe is provided with a sealing member for the needle guard which consists of a sleeve of shrinkable plastic material. The sleeve is shrunk on one side around the needle connection and/or around the barrel or a front part of the barrel, and on the other side around a part of the needle guard adjoining the needle connection.

Abstract: A means for detecting the presence of a transparent liquid in the barrel of a transparent angiography syringe comprising at least one indicator pattern positioned on the exterior of the barrel, the indicator pattern being a discrete, opaque pattern. When the syringe is empty, the indicator pattern is seen as having a first elliptical configuration; however, when the fluid is present in the barrel, the indicator pattern appears to have a second circular configuration, and the difference in apparent configuration is indicative of the presence of the liquid.

Abstract: Instances have been discovered in which a person has inserted the needle of a first hypodermic syringe through the soft rubber drive piston of a second hypodermic syringe to aspirate some of the narcotic fluid from the second syringe into the first syringe. To prevent this mode of pilfering, an impenetrable barrier is included in the second syringe to prevent the insertion of the needle of the first syringe. The impenetrable barrier may be a unitary portion of the screw that is normally included in the drive piston of the syringe, or the barrier may be a separate part molded into the drive piston.

Abstract: An improvement for use with a particular type of hypodermic syringe having a non-retractable stopper located ahead of the drive piston so that the position of the non-retractable stopper indicates the extent to which the drive piston has been advanced. The improvement is a substantially opaque sleeve, or coating applied to the transparent tubular body of the syringe, or a substantially opaque section of the tubular body itself, that is positioned to obstruct the user's view of the non-retractable stopper when the latter is in its original position as supplied by the manufacturer. The front end of the sleeve, coating, or section coincides axially with the front end of the non-retractable stopper so that any forward movement of the non-retractable stopper will expose to view a portion of the non-retractable stopper.

Abstract: A tamper indicating device (24) is connected to the inlet (14) of an injection site (10) which inlet (14) includes a pierceable, self-sealing member (16). The tamper indicating device (24) comprises a cap (26, 28) which covers the inlet (14) rendering the pierceable, self-sealing member (16) inaccessible. A first portion (26) of the cap is connected to the inlet (14) and a second portion (28) of the cap is separated from the first portion (26) by a frangible section (30). A handle (32) extends from the second portion (28) and is operable when actuated to break the second portion (28) away from the first portion (26) at the frangible section (30), rendering the pierceable, self-sealing member (16) accessible. The first portion (26) remains connected to the inlet (14) to indicate that tampering has occurred.

Abstract: It is difficult to detect whether the rubber seal on a vial or on a hypodermic syringe cartridge has been penetrated, because the rubber seal over the mouth of the container is purposely soft and self-sealing to prevent contamination of the fluid within the container. As a result pilfering of narcotics from such containers has gone largely undetected. To remedy this situation, a blister-like sac of a plastic film and containing a harmless dye is mounted within the mouth of the container between the rubber seal and the contents of the container. It is impossible for a hypodermic needle to be inserted through the seal and into the fluid within the container without puncturing the blister-like sac and thereby releasing the harmless dye into the fluid within the container. Thus, if the seal has been broken, the fluid in the container will be tinted with the color of the harmless dye.

Abstract: A visually conspicuous object shaped like a disc or plug is mounted at the mouth of a container or in the neck of the container where it is held only by friction or some other easily-overcome force. The object is impenetrable by a hypodermic needle. When such a needle is thrust through the diaphragm-like seal of the container, the needle strikes the object, and overcomes the friction by which the object was retained in the mouth of the container, thereby releasing the object which then falls or migrates into the body of the container to serve as a visual indicator that the seal has been punctured.

Abstract: An assembly for supporting a cannula comprises a hub which supports the cannula and which includes a post portion which concentrically surrounds a section of the cannula adjacent to the hub. The assembly also includes a cover which is attachable to the post portion of the hub to enclose the cannula. The cover and post portion are coupled together by a "tamper-proof" connection which normally resists removal of the cover, and thereby attests to the sterile integrity of the needle. The connection can be broken in response to the deliberate application of a predetermined rotational force by the user upon the cover and cannot thereafter be recreated, thereby serving as an outward indication that the sterile integrity of the cannula has been compromised. Both the post portion and the cover remain physically intact, despite the breakage of the connection, to permit return of the cover when desired.

Abstract: The inside surface of the glass tubular member of the hypodermic syringe cartridge is made rough along a strip which extends substantially the length of the cartridge. A piece of a solid but easily abradable material is retained on the circumference of the rubber drive piston, and the resiliency of the rubber drive piston squeezes the abradable material against the rough strip on the inside wall of the glass tubular member. As the drive piston is advanced to express fluid from the syringe, some of the abradable material becomes lodged in the rough surface where it remains even after the drive piston has been retracted to its original position. In another embodiment the marking substance is a fluid, paste, or liquid which is stored in a reservoir inside the drive piston and which is squeezed out of the drive piston by the compressive forces that act on the drive piston as it is being advanced.

Abstract: A flexible plastic sealing cover has a container cover area and pull-tab area. In one embodiment, an upper layer of plastic film is substantially impervious to moisture and bacteria. An orientated plastic film layer is bonded to the upper layer with a layer of adhesive, such that the orientated plastic layer promotes tearing when the cover is removed with the pull-tab. An adhesive material is bonded to the layer of orientated plastic film for engaging and sealing the container top of a IV solution container. In removing the sealing cover from a container, telltale strips of the cover are left in engagement with the container to indicate the sterilized seal has been removed. In another embodiment, a single layer of plastic film substantially impervious to moisture and bacteria is bonded with a layer of adhesive material. Slits may be formed in the plastic layer to promote its separation to leave telltale sealing strips on the container upon removal of the cover.