US20160199584A1 - Syringe with Recessed Nose and Protective Guard for Use with Frontal Attachments - Google Patents

Abstract

A medical device connectable to a frontal attachment, the syringe having a forwardly projecting fluid outlet member and a forwardly projecting protective guard extending beyond the outlet member to protect the outlet member from pathogenic contamination by contact prior to connection to the frontal attachment.

Description

RELATED APPLICATION
• This application is a continuation-in-part of and claims the benefit of priority from U.S. patent application Ser. No. 11/743,706 filed May 3, 2007, and from U.S. provisional patent application No. 60/798,433 filed May 5, 2006.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention relates to a medical device, in a preferred embodiment a syringe, either traditional or pre-filled, having a recessed nose and a forwardly projecting, protective guard that cooperate to reduce the likelihood of contamination from accidental or inadvertent contact. The syringe of the invention is intended for use in combination with a frontal attachment such as, for example, a sealing cap, a safety cap, a needle assembly, a luer connector, a CLAVE® connector for introducing liquid into a closed IV system, or another vascular access connector or other proprietary or commercially available frontal attachments. The invention also relates to a structure that protects the nose of a syringe from contamination by contact while simultaneously providing full engagement between cooperating surfaces of a connector provided for frontal attachment to the syringe and reducing the likelihood of disengagement during use. The invention also relates to a method for protecting the tip of a luer connector from contamination without reducing the engagement surface area between the luer of a frontal attachment and the nose of a syringe, thereby reducing the likelihood of fluid leakage at the connection between the frontal attachment and the syringe.
• 2. Description of Related Art
• Catheter-associated bloodstream infections reported from hospitals across the United States have increased since the introduction of needleless devices. According to the U.S. Center for Disease Control, an estimated 250,000 catheter-related bloodstream infections occur in U.S. hospitals each year. Catheter-related infections can cost the U.S. healthcare system up to $25,000 per episode or more. As many as 28,000 patients die each year in the U.S. because of catheter-related bloodstream infections.
• Syringes that utilize frontal attachments such as sealing caps or various types of connectors rather than fixed needles or preset retractable needles for storing, administering or withdrawing medications or fluids are known in the prior art. Syringes made for use with frontal attachments include pre-filled syringes and standard syringes that are shipped without an affixed needle. Such conventional syringes frequently comprise an annular skirt, collar or other opening at or near the front of the syringe barrel in combination with a smaller-diameter nose portion that extends forwardly beyond the annular skirt or collar at the front end of the barrel. Some syringes with attachable needles have a safety mechanism that encircles a portion of the nose but does not protect the tip from contact prior to use. Other syringes have a protective sheath that the user can slide forward over a needle following use.
• Some syringes having a radially spaced-apart annular skirt or collar surrounding a part of the nose also comprise structural elements useful for attaching a needle assembly or other connector to the syringe. With pre-filled syringes, the forwardly extending end of the nose portion is generally either sealed with a membrane to prevent loss of the pre-filled medicament prior to use, or else the syringe is provided with a removable sealing cap that is removed before the needle assembly or connector is attached to the syringe barrel. Once the sealing membrane has been punctured or the sealing cap has been removed, the syringe plunger is depressed and pre filled liquid flows through the attachment.
• Two commercially available types of frontal attachments or connectors are, for example, a CLAVE® connector and a luer connector. The CLAVE brand connector is marketed by ICU Medical and disclosed in U.S. Pat. No. 5,694,686. The CLAVE® connector has a rearwardly facing needle or other sharp object that punctures a sealing membrane in the forwardly extending nose of a prefilled syringe as the connector is threaded into engagement with a collar on the syringe barrel. Following attachment of the CLAVE® connector to both the syringe barrel and to an IV injection port, the syringe plunger is depressed and the pre filled liquid flows out of the syringe through the shaft of the puncturing needle, through the body of the connector and into the closed intravenous (“IV”) Injection system. Other syringes that do not have a permanently affixed needle frequently use a frontal attachment comprising a needle and a luer fitting that is attachable to a cooperatively configured syringe barrel. A luer needle attachment typically has either a flange or external threads that are alignable and engageable with cooperating structural elements disposed inside the annular skirt portion near the front of a syringe barrel.
• Although both types of conventional syringes as discussed above commonly have an annular skirt near the front of the syringe barrel, such conventional syringes are not known to embody a structure that effectively protects or guards the forwardly extending nose portion of the syringe barrel from contamination by direct contact. Such contact can result in the accidental injection of harmful bacteria or other pathogens into a patient's body, thereby contributing to the spread of disease and potentially fatal bacterial or viral infections within supposedly sterile healthcare environments. This risk is believed to be reduced significantly by the invention disclosed and claimed herein.
SUMMARY OF THE INVENTION
• Medical devices intended for use with frontal attachments, such as sealing caps, needle assemblies or needleless connectors, are disclosed herein that substantially reduce the likelihood of accidental pathogenic contamination due to inadvertent contact with the nose of the device. The preferred devices of the present invention are syringes designed so that the nose of each syringe is recessed inside a protective guard that projects forwardly beyond the tip of the nose. The protective guard is desirably either disposed in a fixed axial position relative to the syringe body, or is forwardly biased relative to the syringe body so that it remains in its protective position extending forwardly of the tip of the nose until the biasing force is overpressured to uncover the tip of the nose during connection of a frontal attachment to the syringe. The preferred devices are desirably compatible with commonly available frontal attachments including, for example, sealing caps, safety caps, hypodermic needle assemblies, luer connectors, CLAVE connectors or other vascular access connectors, or other proprietary or commercially available frontal attachments, vial access devices, and luer-activated catheter hubs. Hypodermic needle assemblies can further comprise integrated needle safety components such as, for example, slidable sheaths, pivotable covers and other devices that are designed to protect health care workers from exposure to contaminated sharps. The preferred devices do not transfer contaminants to luer-activated valves or patients. Unlike some devices disclosed in the prior art, the medical devices disclosed herein comprise a structure that distributes and transfers forces generated during threaded engagement of a vascular access connector to a syringe barrel.
• The protective guard of the invention can be made as a unitary part of the body of a medical device, or can be separately made and attached in fixed relation to the device, or can be made so that it is moveable relative to the body of the device. Any frontal attachment to be used with the device is preferably directly attachable to a mounting structure that is disposed in fixed relation to a syringe body. The protective guard of the subject syringes can optionally comprise additional elements that facilitate connection of a sealing cap, needle assembly, needleless connector or other frontal attachment to another portion of the syringe body.
• According to one preferred embodiment of the invention, a syringe is provided that comprises a forwardly extending nose, a protective guard projecting forwardly beyond the tip of the nose, and a mounting structure useful for selectively attaching a frontal attachment to the syringe. According to one particularly preferred embodiment of the invention, the syringe barrel, nose, protective guard and mounting structure are made as a unitary structure. Alternatively, the mounting structure can be manufactured as part of a separate but permanently attachable protective guard or as a unitary part of the syringe body. If made separately from the syringe body, the protective guard can be made so that it is releasably or unreleasably attachable to the syringe body during assembly of the syringe prior to sterilization.
• According to other preferred embodiments of the invention, the syringe and/or the protective guard are made of plastic, glass, or another similarly effective polymeric or non-polymeric material. The protective guard can be substantially rigid or flexible as desired, depending upon the material, the physical configuration, and the method of construction. The protective guard is desirably mounted in fixed axial relation to the syringe body, or alternatively, is mountable to the syringe body in such manner that it can be selectively retracted to uncover the tip of the nose that is otherwise protected by the guard.
• According to another embodiment of the Invention, the forwardly projecting guard is a forwardly projecting, substantially cylindrical outer wall, and further comprises means by which the frontal attachments are connected to the syringe. Because the guard projects forwardly beyond the tip of the nose, the nose is protected from accidental contamination due to inadvertent, incidental contact with a clinician or with objects or surfaces proximal to the syringe prior to affixing the frontal attachment.
• According to another embodiment of the invention, a pre-filled syringe comprises an elongated hollow syringe body made from either glass or plastic. The syringe body has an open nose with a reduced cross-sectional area in the front and an open back end. Disposed in the hollow body is a plunger comprising a plunger seal in sliding sealed contact with the interior wall of the body. The one-piece plunger seals the back end of the syringe body and has a surface for applying thumb force during injections. The nose of the syringe body is preferably sealed with a removable sealing cap. Because the fluid chamber of the syringe is sealed on both ends, the syringe can be pre-filled with liquid and stored until it is used.
• According to another embodiment of the invention, a pre-filled syringe is disclosed that comprises the forwardly projecting guard of the invention and is suitable for use with a CLAVE® connector. The pre-filled syringe of this invention is designed such that the nose tip of the syringe is disposed inwardly of an outer wall of the protective guard that extends beyond the tip of the nose. The recessed nose is protected from contamination due to accidental contact with contaminants prior to attachment of the CLAVE® connector, thereby helping prevent the spread of disease.
• According to another preferred embodiment, the nose of the disclosed pre-filled syringe is protected by and recessed behind a forwardly projecting guard that is part of the syringe body. This forwardly projecting structure prevents contaminating physical contact between the user and the recessed nose after the sealing cap has been removed. The forwardly projecting structure does not completely enclose and cover the recessed nose, but instead protrudes past the tip to prevent inadvertent contaminating contact with the nose. The projecting structure, whether or not it solidly encircles the nose of the syringe, should block, interfere with or otherwise prevent human physical contact with the nose during normal use to protect the nose from contamination.
• According to another embodiment of the invention, a forwardly projecting guard is incorporated onto a standard, non-pre-filled syringe configured so that a needle can be attached using a conventional luer connector. Luer connectors are well known in the art. The present invention protects the nose of a syringe from contamination by contact while simultaneously providing full engagement between cooperating surfaces of a luer connector securing a frontal attachment to the syringe and reducing the likelihood of accidental disengagement during use.
• According to another embodiment of the invention, a method is provided for protecting the tip of a luer connector from contamination without reducing the engagement surface area between the luer of a frontal attachment and the nose of a syringe. This reduces the likelihood of fluid leakage at the connection between the frontal attachment and the syringe. According to one preferred embodiment of the invention, the subject method comprises providing a syringe having a forwardly projecting guard protecting the nose of a syringe and having an engagement surface that facilitates substantially full engagement of the syringe with a cooperating engagement surface of a frontal attachment and that distributes and transfers to the syringe barrel the forces generated during engagement of the frontal attachment.
• According to another preferred embodiment of the invention, the forwardly projecting guard is unitarily molded or otherwise permanently affixed or attached, such as by sonically welding, gluing, or the like, to the syringe body during manufacture.
• According to another embodiment of the invention, a medical device for use with frontal attachments is provided that comprises a nose, a mounting structure in fixed relation to the nose that surrounds the nose and Is internally threaded but does not extend forwardly of the nose, and a protective guard that is normally biased to a position in which it extends beyond the tip of the nose, but is moveable to a position in which the tip of the nose is exposed during connection of a frontal attachment. Prior to use, when the protective guard is biased in its forwardly extending position, the nose is recessed and protected from contamination.
• According to another embodiment of the invention, a structure is disclosed that will simultaneously protect the nose of a medical device intended for use with a frontal attachment from becoming contaminated prior to use and will also reduce the likelihood of the frontal attachment becoming disengaged from the medical device during use.
• According to another embodiment of the invention, a method is disclosed for protecting the tip of a luer connector that is part of a medical device from contamination without diminishing accessibility to the length of the connector by providing a protective guard that projects forwardly beyond the nose to which a luer connector is attachable. The forwardly extending guard preferably does not compromise the integrity of a standard luer interface with a frontal attachment.
BRIEF DESCRIPTION OF THE DRAWINGS
• The apparatus of the invention is further described and explained in relation to the following figures of the drawings wherein:
• FIG. 1 is a side elevation view, partially in section, of one embodiment of a syringe of the invention having a sealing cap, as can be used with a pre-filled syringe, shown in place over a guard projecting forwardly of the nose of the syringe;
• FIG. 2 is an exploded side elevation view, partially in section, of the syringe ofFIG. 1, with the sealing cap removed;
• FIG. 3 is a side elevation view, partially in section, of the syringe ofFIG. 2 that is coaxially aligned with a CLAVE® connector prior to attachment of the CLAVE® connector to the syringe;
• FIG. 4 is a side elevation view, partially in section, of the syringe and CLAVE® connector ofFIG. 3 after the CLAVE® connector has been attached to the front portion of the syringe;
• FIG. 5 is an enlarged detail view of the front portion of the syringe ofFIG. 4, better illustrating the connection between the syringe and the CLAVE® connector;
• FIG. 6 is a side elevation view, partially in section, of the front portion of a syringe of the invention that is coaxially aligned with a needle assembly having a luer connector prior to attachment of the needle assembly to the syringe;
• FIG. 7 is a side elevation view, partially in section, of the syringe and needle assembly ofFIG. 6 after the needle assembly has been attached to the front portion of the syringe;
• FIG. 8 is a front elevation view of a syringe having a guard made as part of the syringe body, the guard comprising an internally threaded cylindrical collar and a plurality of circumferentially spaced, longitudinally extending guard elements projecting forwardly from the cylindrical collar, with arcuate spacing between each most closely adjacent pair of guard elements that is substantially less than the width of each guard element;
• FIG. 9 is a side elevation view of the syringe ofFIG. 8, with the front portion of the syringe shown in cross-section to illustrate how the guard projects forwardly of the nose of the syringe;
• FIG. 10 is an enlarged detail view of the front portion ofFIG. 9 that better illustrates the guard ofFIGS. 8 and 9, and its relationship to the syringe body;
• FIG. 11 is a side elevation view of another embodiment of the syringe of the invention showing a forwardly biased, projecting guard on the front end of the syringe;
• FIG. 12 is a syringe as shown inFIG. 11, but with the front portion shown in cross-section to illustrate how the guard projects forwardly of the nose of the syringe;
• FIG. 13 is an enlarged detail view of the front portion of the syringe ofFIG. 12 that better illustrates the forwardly biased guard projecting forwardly of the nose of the syringe;
• FIG. 14 is an enlarged detail view showing the front portion of the syringe ofFIG. 13 wherein the guard is pushed rearwardly against the biasing force to uncover part of the nose of the syringe;
• FIG. 15 is an exploded front perspective view of another embodiment of the invention having a protective guard that comprises a plurality of circumferentially spaced-apart guard elements, each of which has a free end that projects both forwardly and radially outward from the tip of the nose, which is shown in combination with a cooperating sealing cap that is installable on the front end of the syringe for shipping and storage, and is removable at the time of use; and
• FIG. 16 is a cross-sectional side elevation view, partially broken away, of the syringe ofFIG. 15, with the plunger inserted into the barrel and fully depressed to the position where it will rest at the conclusion of an injection; and
• FIG. 17 is cross-sectional side elevation view of the front portion of the syringe ofFIG. 15 wherein the plunger is inserted into the barrel and is moving forward relative to the barrel as it would be during an injection.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring toFIGS. 1 and 2,pre-filled syringe10 has a body preferably comprisingtubular barrel14,plunger24, and a front end portion ornose16, which has a reduced cross-sectional area relative to thebarrel14, and an openback end portion23. The body ofsyringe10 is preferably molded from a substantially transparent polymeric resin such as polypropylene, but other materials such as other polymeric resins or glass are also acceptable for use in the invention subject to other parameters referred to in this disclosure.
• Disposed in theback end portion23 of thebarrel14 is aplunger24 having a rearwardly projecting handle and aplunger seal26, which may or may not be a separate piece, in sliding sealed contact withinterior wall13 ofbarrel14.Plunger24 seals backend portion23 ofsyringe barrel14 and has anend cap28 for applying thumb force to depressplunger24 and discharge medication fromsyringe10 during use.Nose16 ofsyringe10 has an axial bore with a forwardly facingopening18, andnose16 is desirably covered prior to use with removable sealingcap40. When both openback end portion23 andnose16 of thesyringe barrel14 are sealed prior to use,syringe10 can be pre-filled with liquid invariable fluid chamber15. Once thesyringe10 is filled, vacuum pressure along with friction betweenplunger24 andinterior wall13 will keepplunger24 in place.
• As shown in this embodiment, forwardly projecting,protective guard20 is unitarily molded as part of the body of pre filledsyringe10, and extends forwardlypast nose16. Sealingcap40 is preferably a two-walled structure that slides into engagement over both projectingguard20 andnose16. Inner edge48 ofouter wall46 of sealingcap40 slidably engages the outside of projectingguard20.Inner edge52 ofinner wall50 of sealingcap40 slidably engages the outside ofnose16. As sealingcap40 slides into engagement onpre-filled syringe10, projectingguard20 seats againststop44 andnose16 seats againststop42. When the tip ofnose16 seats againststop42, nose opening18 is sealed. Alternatively, sealingcap40 can have an elastomeric plug or cover placed in or aroundnose opening18, in which caseouter wall46 is unnecessary in order to achieve a fluid-tight seal. At the time of use, sealingcap40 is removed from pre filledsyringe10 while the syringe is held with the nose in an upright position, thus unsealingnose opening18 and also avoiding spillage prior to connecting a frontal attachment device.
• Referring toFIGS. 3 and 4, in a preferred embodimentinner wall22 of forwardly projectingguard20 is threaded to accept thecooperative threads30 on aCLAVE® connector12 once the sealing cap is removed. The CLAVE® connector is preferably, attached to the syringe while the nose is being held in an elevated position relative to the remainder of the variable fluid chamber inside the syringe. The forwardly projectingguard20 is desirably sized and configured so that it extends beyondnose16 and so that the inner diameter is slightly larger than the outer diameter ofCLAVE® connector12.
• A standardCLAVE® connector12 has a forwardly facingopen end32, which is connectable to a closed IV system. TheCLAVE® connector12 has aback section31′, withexternal threads30.External threads30 allowCLAVE® connector12 to be threaded into forwardly projectingguard20 ofpre-filled syringe10. Referring specifically toFIG. 4,CLAVE® connector12 has a rearwardly facingneedle34 that is encircled by backsection31.Rearwardly facing needle34 is in fluid communication with openfront end32.Elastomeric support structure36 restrains lateral movement ofneedle34.
• Referring toFIG. 5, asCLAVE® connector12 is being threaded into the front ofpre-filled syringe10,elastomeric support structure36 moves relative toneedle34, thus exposingneedle34. When fully threaded together,elastomeric support structure36 ofCLAVE® connector12 andnose16 ofpre-filled syringe10 form a fluid-tight seal. WhenCLAVE® connector12 is attached topre-filled syringe10, rearwardly facingneedle34 ofCLAVE® connector12 protrudes throughnose opening18. Medication flows from variablefluid chamber15, throughnose16, throughneedle34 and outCLAVE® connector12 through forwardly facingopen end32, which is typically connected to a closed IV system. In a closed IV system, the forward end of a CLAVE® connector is attached to an IV tube, which is typically also in fluid communication with a bag or bottle containing a fluid being administered to a patient through another IV tube Inserted into a patient's vein.
• Although one preferred embodiment of the invention is described in relation toFIGS. 1-5, it will be understood by those of ordinary skill in the art upon reading this disclosure that forwardly projectingguard20 ofpre-filled syringe10 can similarly be designed to accept frontal attachments other than aCLAVE® connector12 provided that the projectingguard20 extends beyondnose16 so thatnose16 is recessed and protected from contamination, and provided that suitable cooperative attachment structures are provided as part of the syringe body and as part of the device to be attached to the syringe. It should be understood upon reading this disclosure that the frontal attachments can be connected at or near the front of a syringe body by the use of any suitable attachment method and structure having, for example and without limitation, threads, mounting lugs, twist locks, other abutting or frictionally engageable surfaces or interfaces, and other structures having cooperating elements adapted to secure the frontal attachment to a mounting structure on the front of the syringe .body, which mounting structure is an integral part of or securely attached in fixed relation to the body of the syringe. The frontal attachments can be connected either releasably or permanently, but the attachment structure should not be susceptible to fluid leakage when subjected to such hydraulic pressures as are ordinarily experienced during use.
• Referring toFIGS. 6 and 7, another preferred embodiment of the invention is shown wherein forwardly projecting,protective guard62 extends forwardlypast nose66. Forwardly projectingguard62, which is an integral part of or secured in fixed relation to the syringe body, hasinternal threads64 that function as a mounting structure and are sized and configured to receive and cooperatively engageflange54 of the luer connector ofneedle holder58 ofneedle attachment56.Needle assembly56 further comprisesneedle60 that is attached inside a smaller-diameter axial bore providing fluid communication throughneedle holder58.Flange54 of the luer connector ofneedle attachment56 is desirably threaded Intothreads64 ofprotective guard62, creating a fluid-tight seal betweennose66 and luerlock needle attachment56 that utilizes the full length of the cooperating, tapered engagement surfaces on the outside ofnose66 and the inside ofneedle holder58. The luer connector embodiment as shownFIGS. 6 and 7 is intended only for illustrative purposes, and it should be understood and appreciated by those of ordinary skill in the art upon reading this disclosure that other similarly effective mounting structures that are an integral part of or permanently secured In fixed relation to the barrel can be used to attach a needle assembly to the front of a syringe, provided, however, that such structures embody elements that permit the use of a forwardly projecting, protective guard extending beyond the tip of the nose of the syringe and further provided that such protective guards can be used in a manner that is consistent with the stated purpose of preventing contamination by contact.
• Referring toFIGS. 8-10,syringe90 of the invention comprisestubular barrel92 having a slidably engagedplunger96 that can be manipulated usingbarrel flange94 andend cap98.Syringe90 is desirably provided with a protective guard104 (FIG. 10) that, as shown, is an integral part of the syringe body.Guard104 comprises acylindrical collar105 withinternal threads106 and a plurality of circumferentially spaced, longitudinally extendingguard elements108 projecting forwardly fromcylindrical collar105, with a relatively narrowarcuate space109 disposed between each adjacent pair ofguard elements108. In this embodiment, the width ofspaces109 is substantially less than the width of eachguard element108.Spaces109 allowguard elements108 to flex to greater extent than would be possible ifguard104 had a continuous cylindrical or outwardly tapered sidewall. The free ends of longitudinally projectingguard elements108 ofguard104 extend forwardly beyondtip102 ofnose100, and the width ofelongate spaces109 between them is preferably not great enough to permit the fingers of a clinician to pass between them and come into physical contact withnose100. Because the open end ofguard104 that isopposite barrel92 ofsyringe90 extends longitudinally forward of the tip ofnose100,nose100 is protected from physical contact that could contaminate it.Internal threads106 are preferably sized to accept both CLAVE® connectors and needle attachments with luer connectors as previously described in relation to the syringes ofFIGS. 3-7, and other similarly sized conventional frontal attachments not shown in the accompanying drawings.
• Referring toFIGS. 11-14,syringe110 preferably comprises a body having atubular barrel114, finger grips123, a front end portion ornose116 having alongitudinal bore118 with a front-facing opening; aplunger124 withplunger handle128 and a plunger seal (not visible) slidably engageable with the barrel; a unitarily molded mountingstructure120 with internal threads; and aprotective guard126 biased forwardly past the end ofnose116 byspring124. The syringe body is preferably molded from a substantially transparent polymeric resin such as polypropylene, but other polymeric resins or glass are also acceptable materials. In this embodiment of the invention, thefront end portion119 of which is most easily seen inFIGS. 13-14, the forwardly extending end ofnose116 is recessed and protected from contamination by forwardly projecting,protective guard126 that is attached to and supported by internally threaded mountingstructure120. A portion ofnose116 is encircled by mountingstructure120, andinternal threads122 are preferably sized and configured to accept conventional CLAVE® connectors, needle attachments with Luer connectors (not shown), or other similarly sized frontal attachments.Protective guard126 slidably engages the outside surface of mountingstructure120 and is moveable between an extended position (as shown inFIGS. 11-13) whereinspring124 is expanded, and a retracted position (as shown inFIG. 14) whereinspring124 is compressed by aforce138. Whenprotective guard126 is biased into its forwardly extending position, the front end ofnose116 is recessed and protected from contamination by physical contact.
• Outwardly-facingannular boss130 is preferably provided on mountingstructure120, and abuts against inwardly-facingannular boss132 onprotective guard126, opposing the biasing force fromspring124 and preventingprotective guard126 from detaching from mountingstructure120 ofsyringe110. Referring specifically toFIG. 14 wherein forwardly biasedprotective guard126 is in its retracted position,spring124 is compressed andnose116 is no longer recessed. In this position, inwardly-facingannular boss134 is abutted against outwardly-facingannular boss130 on mountingstructure120, which preventsprotective guard126 from being retracted too far andover-compressing spring124. The cooperation betweenannular bosses130,132 and134 limits the range of motion ofprotective guard128. Because of the expansion force ofspring124,protective guard126 is always in its extended, protecting position until some additional rearwardly directedoutside force138 is exerted against it, either directly by the user or indirectly by an abutting surface of a frontal attachment as will occur, for example, during the attachment of a CLAVE® connector or other frontal attachment to the syringe.
• Still another preferred embodiment of the invention is described and explained in relation toFIGS. 15-18.FIG. 15 illustrates asyringe140 that is similar in most respects to syringe110 (as previously described in relation toFIGS. 8-10) in combination with a sealingcap142 that is removed prior to use ofsyringe140 with a frontal attachment.Syringe140 comprises abarrel148 with a slidably insertable plunger having aplunger handle144 and aplunger seal146, and a forwardly extending nose with aprotective guard150 that is further described in relation toFIGS. 16-17. Referring toFIGS. 16-17,protective guard150,integral mounting structure160 with internal threads, andnose158 are unitarily molded as part of the body ofsyringe140.Protective guard150 further comprises a plurality of circumferentially spaced-apart, longitudinally extendingguard elements152 separated byelongate spaces154. In this embodiment of the invention, in contrast to the embodiment ofFIGS. 8-10, the forwardly facing free ends ofguard elements152 flare or taper radially outward relative tonose158 as they extend away from mountingstructure160.FIG. 17 depictsplunger handle144, withplunger seal146 attached to its front end, moving forwardly throughbarrel148 as indicated byarrow162.FIG. 16 depicts plunger handle144 andplunger146 seated in the front end ofbarrel148 following completion of an injection.
• It will be understood and appreciated by those of ordinary skill in the art upon reading this disclosure that other materials such as, for example, paper, cardboard, foil, or a polymeric material can be used to fabricate a protective band that can similarly function as a protective guard for the nose of a medical device after the device is removed from its sterile packaging but prior to connection to a frontal attachment. Other alterations and modifications of the invention will likewise become apparent to those of ordinary skill in the art upon reading the present disclosure, and it is intended that the scope of the invention disclosed herein be limited only by the broadest interpretation of the appended claims to which the inventors are legally entitled.

Claims (11)

1-11. (canceled)

13. A syringe having an internal fluid path, said syringe comprising:

a body;

a plunger insertable into the body;

a forwardly projecting fluid outlet member that is insertable into fluid communication with a frontal attachment and releasably connectable to the frontal attachment; and

a protective guard projecting forwardly beyond the fluid outlet member to protect the fluid outlet member from pathogenic contamination by contact prior to being releasably connected to the frontal attachment;

wherein the protective guard is made separately from the body and is attachable to the body.

15-19. (canceled)

19. A syringe having an internal fluid path, said syringe comprising:

a body;

a plunger insertable into the body;

a forwardly projecting fluid outlet member that is insertable into fluid communication with a frontal attachment and releasably connectable to the frontal attachment; and

a protective guard projecting forwardly beyond the fluid outlet member to protect the fluid outlet member from pathogenic contamination by contact prior to being releasably connected to the frontal attachment;

wherein the protective guard comprises a first part connected in fixed relation to the syringe body and a second part that slidably engages the first part and is biased to a position where it extends forwardly of the forwardly projecting fluid outlet member.

20. The syringe ofclaim 19 wherein the second part is biased by a compression spring disposed around the first part.

22-34. (canceled)

34. A syringe having an internal fluid path, said syringe comprising:

a body;

a plunger insertable into the body;

a luer connection surface;

a mounting structure disposed in fixed relation to the luer connection surface; and

a protective guard projecting forwardly beyond and protecting the luer connection surface from pathogenic contamination by contact;

wherein the protective guard is made separately from the body and is attachable to the body.

36-41. (canceled)

41. A syringe having an internal fluid path, said syringe comprising:

a body;

a plunger insertable into the body;

a luer connection surface;

a mounting structure disposed in fixed relation to the luer connection; and

a protective guard projecting forwardly beyond and protecting the luer connection surface from pathogenic contamination by contact;

wherein the protective guard comprises a first part connected in fixed relation to the syringe body and a second part that slidably engages the first part and is biased to a position where it extends forwardly of the luer connection surface.

42. The syringe ofclaim 41 wherein the second part is biased by a compression spring disposed around the first part.

44-46. (canceled)

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