Syringe with recessed nose for use with frontal attachments

AT THE AMERICAN OFFICE OF PATENTS AND TRADEMARKS

SYRINGE WITH HOLLOW FRONT PART INTENDED TO BE USED WITH FRONT FASTENERS

RELATED REQUEST

[0001] The present application claims the benefit of provisional US patent application serial number 60 / 798,433 filed May 5, 2006 and entitled Syringe with recessed front part intended for use with front bindings.

HISTORY OF THE INVENTION

1. Field of Invention

The present invention relates to a medical device and more particularly to a syringe, either traditional or pre-filled, having a section with a recessed front part adapted to avoid contamination by human contact when connecting a front binding such as a connector CLAVE® for the introduction of drugs into a closed IV system or Luer Lock needle attachment.

2. 'Description of the Related Art

[0003] Syringes which use front attachments rather than having a retractable needle attached or pre-established are known in the prior art. Various front attachments are used with these syringes, and generally, the front attachments are threaded on a part which surrounds the front part of the syringe. The putie i30490

The front of the prior art syringes extends beyond this encircling structure and includes the leading edge of the syringe. There are two main types of syringes that use front attachments: pre-filled syringes and standard syringes that are loaded without a needle attached.

[0004] Certain types of pre-filled syringes are suitable for use with various fixings such as the CLAVE brand connector marketed by ICU Medical and disclosed in US patent 5,694,686. With this design, when the syringe is ready for use, a fastener is connected to the front. This fastener has a needle or other sharp object facing backwards which perforates the sealing membrane from the outside. The syringe plunger is lowered and the liquid prefilled

<td>flowed</td><td colspan="2">of the syringe by the</td><td>bias of ؛</td><td>the</td><td>rod</td><td>of</td>

<td colspan="2">! 'piercing needle.</td><td>through</td><td>fixation</td><td>and</td><td>in</td><td>a</td>

<td>system</td><td>closed IV. The</td><td>syringes</td><td>pre-filled</td><td>who</td><td>have</td><td>a</td>

<td>capsule</td><td>capping</td><td>removable</td><td colspan="2">rather than one</td><td colspan="2">membrane</td>

sealing, work with fasteners in the same way. The capsule is removed and the fastener is connected to the front of the syringe via the internal thread on the encircling structure. The syringe plunger is lowered and the pre-filled fluid flows through the attachment.

[0005] Some syringes which do not have a permanently attached needle use the Luer Lock mechanism to attach or remove the needle. In this type of syringe, the needle is. held by a Luer Lock needle attachment having either a flange or an external thread which is capable of being threaded onto the syringe. Like the pre-filled syringe discussed above, the Luer Lock syringe has a threaded structure surrounding the front portion which is adapted to accept the Luer Lock needle attachment flange or thread.

[0006] The main drawback of these two types of syringes is that the front part of the syringe body is exposed to contamination due to its position as the front edge of the syringe. The front part can be easily contaminated by human contact.

The rise of life-threatening staphylococci and other infections due to the use of pre-filled and / or standard syringes in conjunction with needleless systems, and access ports which are integrated in needleless systems, is addressed. by the present invention by recessing the front portion of the syringe behind an extended projection or projections, which is in the preferred embodiment an encircling outer wall. By extending the projections beyond the end of the front part, the front part is no longer the front edge of the syringe and is protected from contamination from human contact.

ABSTRACT OF THE INVENTION

[0007] Syringes for use having front attachments are disclosed herein which offer significant advantages over the prior art. The syringes of the present invention are designed such that the front portion of the syringes is recessed behind a projection or projections which extend beyond the end of the front portion. In the preferred embodiment, the projections are an encircling outer wall, which provides the means by which the front attachments are connected to the syringe. By extending the outer wall beyond the advancing portion, the recessed front portion is protected against contamination due to accidental contact with contaminants prior to installation of the front binding.

[0008] The first disclosed embodiment relates to a pre-filled syringe for use with a CLAVE® connector which offers significant advantages over the pre-filled syringes of the prior art. The pre-filled syringe of the present invention is designed such that the front portion of the syringe is recessed within a surrounding exterior wall which extends beyond the end of the front portion. The recessed front part is protected against contamination due to accidental contact with contaminants before fixing the CLAVE® fitting. The front part is not exposed to human contact, which helps prevent the spread of the disease. ......

[0009] The pre-filled syringe of the invention comprises an elongated, hollow syringe body made of either glass or plastic. The syringe body has an open front portion having a region of reduced cross section at the front and an open rear portion. A piston is disposed in the hollow body, which piston comprises a piston seal in sliding sealing contact with the interior wall of the body. The one-piece plunger seals the rear portion of the syringe body and has a surface for applying thumb force during injections. The front part of the syringe body is sealed with a removable stopper. Since the syringe is sealed at both ends, it can be pre-filled with stored liquid until needed.

The front part of the disclosed pre-filled syringe is protected by and recessed behind a forwardly projecting structure which forms part of the body of the syringe. This forward projecting structure prevents contaminating physical contact between the user and the recessed front portion after the stopper has been removed. The forward projecting structure does not close and completely cover the recessed front part; it only protrudes from the end in order to prevent human contact with the front part.

[0011] In a preferred embodiment of the invention, the protruding structure hollowing out the front portion of the syringe body is configured such that a CLAVE® connector can be attached at the time of use. Part of this protruding structure encircles the front part and is threaded to accept the external thread from the CLAVE® fitting. The part of this projecting structure which projects beyond the front part may be either a solid encircling wall or another equivalent structure, for example a plurality of fingers which do not securely encircle the front part. The protruding structure, whether it encircles securely or not, must block, hinder or otherwise prevent human physical contact with the front part to protect the latter from contamination.

[0012] At the time of use, the removable cap is removed while the pre-filled syringe is held upright, and the CLAVE® connector is attached. In this embodiment, the protruding structure encircles the front portion of the syringe body and extends a distance beyond the end. The inner wall of the encircling protrusion structure is cooperatively threaded to accept the corresponding thread of a CLAVE® fitting. The CLAVE® connector has a needle pointing rearwardly inside protected by an elastomeric backing, and the needle is in fluid communication with the forward end of the connector. Threading the CLAVE® connector on the pre-filled syringe causes the elastomeric holder to move relative to the static needle and expose the needle. The front of the syringe and the elastomeric holder create a fluid seal when the CLAVE® fitting is fully threaded on the pre-filled syringe. ' Then, as the plunger of the pre-filled syringe is lowered, the medicine will flow through the front of the syringe, through

-٦-

<td>!'needle</td><td>of</td><td colspan="2">CLAVE® fitting and through 1</td><td>'end</td><td>before</td>

<td>of the fitting</td><td>and</td><td colspan="2">in a closed system IV.</td><td>In a sy</td><td>tern</td>

<td>closed IV,</td><td> 1'</td><td>front end</td><td colspan="2">a CLAVE® fitting</td><td>is</td>

<td>attached to</td><td>a</td><td>IV tube, which is</td><td colspan="2">in fluid communication</td><td>with</td>

<td colspan="2">a bottle</td><td>of fluid. The</td><td>bottle of</td><td colspan="2">fluid disposes</td>

<td>of another</td><td colspan="2">IV tube, which is</td><td>inserted in</td><td>a vein</td><td>of a</td>

<td>patient.</td><td></td><td></td><td></td><td></td><td></td>

<td colspan="2"> [0013]</td><td>A mode of</td><td>production</td><td>alternative</td><td>is</td>

<td colspan="2">disclosed in</td><td colspan="2">which structure making</td><td colspan="2">hollow protrusion</td>

the front part is incorporated on a standard non-prefilled syringe configured so that a needle can be attached by means of a luer lock mechanism. Luer lock mechanisms are well known in the art and generally consist of a Luer Lock needle holder attachment which threads into a threaded ring inside the front edge of a syringe. This embodiment differs from other Luer Lock syringes in that the Luer Lock threaded protrusion structure is extended beyond the end of the front portion; thus hollowing out the front part and protecting it against contamination due to human contact.

[0014] In a preferred configuration of the two embodiments, the protruding structure is attached or permanently fixed to the body of the syringe during manufacture. However, it is also understood that the protruding structure can be a separate part which the user can attach to the syringe before use. The syringe body and the separate protruding structure may have

Cooperating threads to allow the protruding structure to be threaded onto the body, or the separate protruding structure can be attached by friction adjustment or snap-fit ​​through the use of recesses and bosses or small lips. corresponding deductions.

[0015] The novel features and construction of the present invention, as well as additional objects thereof, will be fully understood from the following description when read in conjunction with the accompanying drawings.

CONCISE DESCRIPTION OF THE DRAWINGS

[0016] The apparatus of the invention is described and explained further in connection with the following figures of the drawings in which:

FIG. 1 is an elevational view, partially in section, of the pre-filled syringe with the stopper in place.

FIG. 2 is an elevational view, partially in section, of the prefilled syringe with the stopper removed.

FIG. 3 is an elevation view, partially in section, of the pre-filled syringe and the CLAVE® connector before the attachment of the CLAVE® connector;

FIG. 4 is an elevation view, partially in section, of the pre-filled syringe and the CLAVE® connector after the CLAVE® connector has been fixed;

FIG. 5 is a detailed view of the oval area 5 of FIG. 4 better illustrating the coupling between the pre-filled syringe and the CLAVE® connector;

FIG. 6 is an elevational view, partially in section, of the Luer Lock syringe and the Luer Lock needle prior to the attachment of the Luer Lock needle;

FIG. 7 is an elevation view, partially in section, of the Luer Lock syringe and the Luer Lock needle 25 after the Luer Lock needle has been attached;

FIG. 8 is a partially exploded perspective view of the syringe showing the protruding structure which tightly encircles; and

FIG. 9 is a partially exploded perspective view of the syringe showing an alternate protruding structure which does not encircle securely.

Like reference numerals are used to describe like elements in all figures of the drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] With reference to FIGS. 1 and 2, the prefilled syringe 10 preferably comprises the tubular housing 14 and the plunger 24. The housing 14 has a front end portion or front portion 16, which has a reduced cross-sectional area relative to the housing 14, and an open rear end portion 23. Housing 14 is preferably molded from a substantially transparent polymeric resin such as polypropylene, but other polymeric resins or glass are also acceptable materials.

A piston 24 is disposed in the rear end portion 23 of the housing 14, which piston comprises a piston seal 26, which may or may not be a separate part, in sliding sealing contact with the inner wall 13 of the housing 14. The one-piece plunger 24 seals the rear end portion 23 of the syringe housing 14 and has an end cap 28 for applying thumb force to lower the plunger. 24 and discharge the drug from syringe 10 during use. The front portion 16 of the syringe 10 has an opening 18, and the front portion 16 is sealed prior to use with the removable cap 40. Since both the open rear end portion 23 and the front portion 16 of the syringe housing 14 are sealed prior to use, the syringe 10 can be pre-filled with liquid in a variable fluid chamber 15 . Once the syringe 10 is filled, the vacuum pressure along with the friction between the piston 24 and the wall. 13 interior

-12 will hold piston 24 in place.

The structure 20 projecting from the prefilled syringe 10 extends forward beyond the portion 16 before. The closure cap 40 is a two-walled structure which fits by sliding both on the projecting structure 20 and on the front part 16. The inner edge 48 of the outer wall 46 of the closure capsule 40 slidably engages the exterior of the projecting structure 20. The inner edge 52 of the inner wall 50 of the stopper capsule 40 'slidably engages the outside of the front portion 16. As the stopper 40 is slid over the pre-filled syringe 10, the protruding structure 20 is against the stop 44 and the front part 16 is against the stop 42. By the front part 16 against the stop ! 'stop 42,!' opening 18 of the front part is sealed. Alternatively, the stopper capsule 40 may have an elastometic pad placed in the opening 18 of the front part, in which case the outer wall 46 would be little necessary to provide a leaktight seal. At the time of use, the stopper 40 is withdrawn from the prefilled syringe 10, thus unsealing the opening 18 of the front part.

[0021] With reference to FIGS. 3 and 4, in a preferred embodiment the inner wall 22 of the protruding structure 20 is threaded to accept the corresponding thread 30 on a CLAVE® fitting 12. The protruding structure 20 is sized such that it extends past the front portion 16 and the inside diameter is a little larger than the outside diameter of the CLAVE® fitting 12.

[0022] A standard CLAVE® connector 12 has an open end 32 facing forward, which is connectable to a closed IV system. The 12 CLAVE® fitting has a rear 5 section 31, which is covered with the external 30 thread. The external thread 30 allows the CLAVE® connector 12 to be threaded into the structure 20 protruding from the pre-filled syringe 10. With specific reference to FIG. 4, CLAVE® fitting 12 has a rear facing needle 34 which is encircled by rear section 31. The rearward facing needle 34 is in fluid communication with the open forward end 32. The outer thread 30 is part of an encircling structure which protects and hollows out the needle 34 pointing 15 backwards from the CLAVE® fitting 12. The elastomeric support structure 36 prevents the needle 34 from moving sideways.

[0023] Referring to FIG. 5, the pre-filled syringe 10 and the CLAVE® connector 12 are threaded together 20 by use of the internal thread 22 of the protruding structure and the external thread 30 of the CLAVE® connector 12. As the CLAVE® connector 12 is threaded onto the pre-filled syringe 10, the elastomeric support structure 36 moves relative to the needle 34, thereby exposing the needle 34. When fully threaded together, the elastomeric support structure 36 of the CLAVE® connector 12 and the front portion 16 of the prefilled syringe 10 create a fluid seal. By attaching the CLAVE® connector 12 to the pre-filled syringe 10, the needle 34 pointing 30 towards the rear of the CLAVE® connector 12 protrudes into the

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The opening 18 of the front part. The drug flows from the variable fluid chamber 15, through the front part

16, through the needle 34 and out of the fitting 12

CLAVE® through the open end 32 facing forward.

[0024] Although a preferred embodiment of the invention is shown in FIGS. 1-5, it will be understood by those skilled in the art upon reading this disclosure that the structure 20 protruding from the pre-filled syringe 10 10 may be similarly designed to accept fasteners other than a CLAVE® connector 12 to. provided that the protruding structure 20 extends beyond the front portion 16 such that the front portion 16 is recessed and protected from contamination. Although a fastening of the CLAVE® fitting is threaded with the protruding structure, it is foreseeable that a smooth protruding structure on the inside could be used to protect the front portion 16 which would be usable for other fasteners not. threaded, such as fasteners 20 which are held in place relative to the syringe by friction or pressure adjustment.

[0025] With reference to FIGS. 6 and 7, a further preferred embodiment of the invention is shown in which the protruding structure 32 extends forward 25 beyond the front portion 66. The protruding structure 62 has an internal thread 64. which is sized to accept the flange 54 of the luer lock needle attachment 56. The Luer Lock needle attachment 56 comprises the needle 60 and the needle holder 5'8, in which the needle holder 58 has the flange 54. The collar 54 of

The Luer Lock needle attachment 56 is threaded into the protruding structure 62 creating a fluid seal between the front portion 66 and the Luer Lock needle attachment 56. The Luer Lock embodiment of

FIGS. 6 and 7 is intended to be exemplary only, and it is understood that there are many other ways of temporarily attaching a needle to the front of a syringe beyond the thread structure which is shown in which the contamination Human contact can be avoided by recessing the front part behind a protruding structure.

[0026] Referring to FIG. 8, in a preferred embodiment, the protruding structure 20 is a rigid wall which completely surrounds the front portion 15 16 of the syringe 10. The protruding structure 20 attaches to the body 14 of the syringe and extends across. beyond the front portion 16. Referring to FIG. 9, an alternative embodiment is shown, in which the structure

<td></td><td>20 'doing</td><td colspan="2">protrusion is not a</td><td>pao</td><td>encirclement</td>

<td> 20</td><td>solid but</td><td>rather has a</td><td colspan="2">plurality</td><td>٠ fingers in</td>

<td></td><td>protrusion, which</td><td>extend beyond</td><td>the</td><td>part</td><td>before 16 of the</td>

<td></td><td>syringe 10.</td><td></td><td></td><td></td><td></td>

[0027] Other changes and modifications of the invention will also become apparent to those skilled in the art upon reading this disclosure, and it is intended that the scope of the invention disclosed herein will be limited only by i broadest interpretation of the appended claims to which inventors are legally entitled.