NZ241594A - Hypodermic syringe shield. - Google Patents

Description

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Patents Form No. 5 i N.Z. P.... 11 FEB 1992 RECEIVED LUL11HNW NEW ZEALAND PATENTS ACT 1953 COMPLETE SPECIFICATION NEEDLE SHIELD WE, AMERICAN HOME PRODUCTS CORPORATION, a corporation under the state of Delaware, U.S.A. of 685 Third Avenue, New York, New York 10017, U.S.A. hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement: (followed by page la) * NEEDLE SHIELD BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a shield for a hypodermic syringe assembly. More particularly, the present invention relates to a shield which can be retrofitted over an existing sheath/needle cannula sub-assembly of a hypodermic syringe assembly. Even more particularly, the present invention relates to a rigid shield which can be retrofitted over a resilient sheath which is being used to seal the distal end of a needle cannula of a prefilled hypodermic syringe prior to its use, the shield functioning to prevent needle sticks due to accidental piercing of the resilient sheath by the needle cannula. 2. Description of the Prior Art It is common practice in the preparation of medications for use by medical workers, to pre-packaging the medications directly within a sealed hypodermic syringe assembly when such is a necessary vehicle for administration of the medication to a patient. According to this practice, a hypodermic syringe is prefilled with a predetermined amount of medication, and the medication is sealed into the syringe by sealing the distal end of the needle cannula. The syringe is then packaged singly or in a predetermined quantity, into packaging which can be sterilized and maintain the sterility of the syringes until the medication is to be administered to a patient. In following this procedure, it has often been the practice to seal the distal end of the needle cannula with a resilient needle sheath. A sheath of this type is usually formed of a resilient rubber material with an elongate cavity therein which can accept the needle cannula. Generally, the sheath is formed so as to be capable of forming a friction fit with the hub of the needle cannula to hold the sheath in position over the needle. The cavity is sized so as to either fit snugly around the distal la (followed by page 2) S-7858 tip of the needle cannula, or allow the distal tip of the needle cannula to pierce the distal end of the sheath and become embedded therein. In either case, the sheath effectively seals the tip of the needle cannula to prevent fluid 5 from flowing therethrough out of the syringe during storage or prior to use.

Although the resilient needle sheath is generally quite successful in sealing the needle cannula, there remains serious concerns in the use thereof, specifically, due to 10 the piercability of the sheath, there exists a possibility of medical workers accidentally receiving a needle stick while using the syringe. This usually occurs either during preparation of the syringe for administration of medication to a patient, or during disposal procedures therefor. For 15 example, since the sheath is formed of a resilient rubber, a minimal force improperly applied is all that is needed to cause the needle tip to penetrate (and even pierce entirely through) the sheath. Therefore, inadvertent pressure on the tip of the sheath while the needle is properly placed there-20 in, may cause the needle to pierce entirely through the sheath's distal end and become exposed.

Further, medical workers often attempt to reinsert the needle into the sheath after the syringe has been used and prior to its disposal, even though this procedure is gener-25 ally not recommended. Misalignment of the needle with the sheath during reinsertion can cause the tip of the needle to pierce through the side of the sheath where it may contact the hand of the medical worker holding it. Needle protrusion of this nature can readily occur since the tip of 30 commonly used needles is ground off-center (i.e. on a bias) and therefore does not proceed in a linear path when piercing the resilient sheath material. Instead, the needle tends to follow the off centered point as it passes through the sheath and in effect "skives off" in an arcing path of 35 travel as it passes through the sheath material. If a medical worker is not extremely careful to let the needle center itself in the sheath cavity during reinsertion, the 2 f ATE A A S-7858 8 needle may inadvertently contact the side of the sheath cavity and pierce through the sheath material in a surprisingly unexpected direction, catching the medical worker off guard and likely causing a stick to the hand of the medical 5 worker which is being used to hold the sheath.

Although rigid, substantially impenetrable shields are commonly used to cover needle cannulas of hypodermic syringe assemblies, they are generally unsuitable for use on syringes which have been prefilled with a fluid such as a liquid 10 medicament due to their inability to seal the end of the needle cannula from fluid flow therethrough during storage and prior to use.

There have been attempts in the past to develop a substantially impenetrable shield which can be positioned 15 over a resilient sheath commonly used on prefilled syringes in order to provide added protection to a medical worker from accidental needle sticks. For example, U.S. Patent No. 4,964,866 to Szwarc discloses a needle shield assembly for use on a prefilled syringe. The assembly includes a resil-20 ient sheath, generally of the above described prior art construction, permanently enclosed in a rigid shield. The entire needle shield assembly (including the resilient sheath permanently enclosed in the rigid shield) is positioned over the needle cannula and thus seals the lumen of 25 the needle cannula while simultaneously preventing needle sticks due to an accidental protrusion of the needle through the sheath.

Although this invention is a substantial improvement over the use of a resilient sheath alone in preventing 30 accidental needle sticks,it is nevertheless somewhat limited in its use, and generally unadaptable to the myriad of different structural designs of commonly used prefilled hypodermic syringe assemblies. Specifically, the Szwarc needle shield assembly cannot be conveniently used to retro-35 fit previously filled, sheathed, and sterilized prefilled hypodermic syringe assemblies. Also, the design of the Szwarc device prevents its use as a retrofittable sub-assem- 3 9 'L h 15 94 PATENTS S-7858 bly over a previously sheathed hypodermic syringe in order to afford the added protection of the substantially impenetrable shield against the possibility of needle sticks. Contrarily, the Szwarc shield is manufactured in such a way 5 as to require its assembly about the sheath prior to the sheath's placement over the needle cannula, thus preventing any use thereof as a retrofit over a previously sheathed and sterilized needle cannula.

There exists therefore a need to develop a shield which 10 can be retrofitted over a sheath of a prefilled hypodermic syringe assembly by a medical worker after the sheath has been positioned, and prior to using the assembly. Further, it is necessary that such retrofitting procedure not compromise the sterility of the needle prior to its use. 15 An attempt to use the Szwarc device in a retrofit manner would necessitate the removal of the original resilient sheath which was placed over the needle cannula prior to its sterilization, and subsequent insertion thereover of Szwarc's sheath/needle sub-assembly. Such a procedure would 20 likely not be recommended due to the possibility of contamination of the needle cannula during the retrofitting process.

There also exists a need in the prior art to develop a needle shield which can be used on various sizes and lengths 25 of needle cannula and sheaths therefor. Since it is important for a sheath to be properly sized in order to seal a needle cannula, the Szwarc device, in order to properly function to seal a needle cannula, must generally be manufactured to dimensions required by a particular syringe 30 assembly design. Therefore, other needle cannula's (and sheath's therefor) of a substantially different size (e.g. shorter or longer in length) than specifically anticipated by Scwarc's design, cannot be used therewith.

Staebler, in U.S. Patent No. 4,742,910, teaches a 35 needle sheath holder which consists of a hollow barrel member adapted to be held in the hand of a medical worker, which includes a protective plate mounted to an open end of 4 ' PATEllrJl S-7858 the barrel through which a sheath/needle sub-assembly of a hypodermic syringe assembly can be inserted. The plate is designed to protect the medical worker's hand during the insertion process. The Staebler device also includes a 5 plurality of flexible gripper members attached at the barrel opening, which are intended to engage the needle sheath so as to retain the needle sheath within the barrel.

Although the Staebler device seems an improvement over the Szwarc device in its retrofit capabilities, it neverthe-10 less suffers from several drawbacks. Most notably, the Staebler device includes three separate parts (i.e., the barrel, the plate, the gripper members) which must be individually manufactured and subsequently assembled, resulting in relatively expensive manufacturing costs. Further, it is 15 not readily evident from the Staebler disclosure that a sheath formed of resilient material, such as resilient rubber (as opposed to what seems to be shown by Staebler as a relatively rigid sheath) could be successfully inserted into and retained by staebler's barrel shield. There there-20 fore exists a need in the prior art to develop a retrofitt-able shield for use over a resilient sheath of a hypodermic syringe assembly which is simple in design and inexpensive to manufacture.

In U.S. Patent No. 4,636,201 to Ambrose et al. teaches 25 the placement of a rigid shield over a rubber sheath of a hypodermic syringe. The rigid shield includes a plurality of spaced teeth members which are located at (and essentially form) the opening of the shield through which the sheath/needle sub-assembly of the syringe assembly is to be 30 inserted. At least a pair of the teeth of the shield include a lip which projects inwardly toward the center of the opening for closing in over the proximal end of the sheath once completely inserted into the shield.

Although Ambrose et al. allows a retrofit procedure to 35 be performed on a hypodermic syringe assembly in a manner similar to Staebler, and also anticipates use of its device over a resilient sheath, there are nevertheless several WteiUS^ S-7858 important drawbacks of the Ambrose et al. device. Specifically, due to the Ambrose et al. design, there remains a chance for accidental needle sticks to a medical worker even after the tip of the needle has already been inserted into 5 the shield. This is due to the necessary placement of the open slots between adjacent teeth at the open end of the shield. In other words, there exists the possibility of a needle entering the shield at such an angle that it may subsequently pass back out of the shield through one of the 10 slots and result in a stick the medical worker.

More importantly, due to the location of the teeth on the Ambrose et al. device, it is difficult to ensure that a proper grip of the teeth about the proximal end of the sheath will occur. Many prior art sheath designs call for 15 insertion of the sheath over the syringe needle hub until the proximal end of the sheath abuts a shoulder of the hub (generally at a location where the hub changes from a larger to a smaller diameter). This is a common design characteristic of syringe and is useful to insure sealing of the 20 sheath over the needle hub. It also gives medical workers a visual and tactile indication that the sheath is properly positioned on the hub. In such designs, there is no room for the teeth of the Ambrose et al. device to slip between the hub shoulder and the proximal end of a properly placed 25 sheath in order to grip and retain the sheath in the manner disclosed. Due to this fact, use of the Ambrose et al. device on many common needle hub and sheath design will not allow the teeth of the shield to properly attach themselves about the proximal end of the sheath. Only syringes having 30 a sheath/needle design which does not include abutment of the proximal end of the sheath against a shoulder of the needle hub will function properly with the Ambrose et al. device. Such a design limitation substantially inhibits the use of the Ambrose et al. device for purposes of retrofitt-35 ing various common prefilled hypodermic syringe assemblies. 6 PATENTS S-7858 Further, medical workers may be hesitant to employ the Ambrose et al. device for retrofitting over sheaths of hypodermic syringe assemblies if they feel the shield may be less than completely reliable in gripping and retaining the 5 sheath (e.g., due to the difficulties it may encounter if used on syringe assemblies having a design of the sheath/needle sub-assembly connection which differs from that shown in the Ambrose et al. disclosure).

Although it may seem at first glance that this problem 10 may be avoided by initially partially removing the sheath from the needle hub prior to inserting the sheath into the Ambrose et al. shield (in order to space the proximal end of the sheath from the hub shoulder) such a procedure would likely be very unpopular with the medical workers due to the 15 inconvenience thereof. Such would also likely fail to resolve the problem since the teeth of the Ambrose et al. needle shield, contact and are forced apart by the sheath as the shield is positioned thereover. The teeth therefore force the sheath in the direction of the needle hub during 20 placement of the shield. Subsequently, any attempt to separate the proximal end of the sheath from a shoulder of the needle hub prior to placement of the shield would be opposed by the force of the teeth on the sheath and likely replace the proximal end thereof into abutting relationship 25 with the shoulder of the needle hub prior to complete* insertion of the sheath into the shield. The result would again be that the teeth would not be able to properly and securely grip the sheath.

There therefore exists a need in the prior art to 30 develop a shield which can retrofitted over an existing sheath of a prefilled hypodermic needle assembly and retain the sheath in the shield during subsequent removal and/or insertion of the needle into the sheath, without regard to the particular design of the sheath/needle hub connection. 35 Although the above prior art discloses a plurality of rigid shields used to protect medical workers against needle sticks from hypodermic syringes having resilient sheaths, 7 there nevertheless continues to be a need for a rigid, substantially impermeable needle shield which can be simply and easily retrofitted over a range of sizes and designs of prefilled hypodermic syringes, without compromising the 5 sterility of the needle cannula and with complete reliability of retention of the sheath in the shield. Further, such a needle shield is needle which can also be manufactured as a single integral unit requiring no assembly of individual parts, so as to be simple to manufacture and relatively 10 inexpensive.

OBJECTS AND SUMMARY OF THE INVENTION It is an object of the present invention to provide a shield for use on a prefilled hypodermic syringe having a resilient sheath thereover, which is easily retrofittable 15 over the sheath and which permanently retains the sheath therein once the shield is retrofitted thereover.

It is another object of the present invention to provide a retrofittable shield, such as described above, which can be used on a variety of sizes of sheath/needle cannula 20 sub-assemblies of prefilled hypodermic syringe assemblies.

It is further an object of the present invention to provide a shield as described above which is easily manufac-turable as a single integral unit in an efficient and inexpensive manner.

These and other objects of the present invention are disclosed, by way of example and not necessarily by way of limitation, in presently preferred embodiments thereof. A needle shield made in accordance with the principles of the present invention includes an elongate tubular housing 30 having formed therein an elongate chamber, preferably open at its proximal end. The housing includes retention members preferably formed therefrom, which protrude into the chamber and which may be oriented in a predetermined pattern and shaped so as to allow insertion of a resilient sheath (which 35 covers a needle cannula) into the chamber with minimal 8 'PA§E10S' S-7858 resistance, yet allow sufficient gripping to inhibit removal of the sheath from the chamber after insertion. The present invention is intended to function to cause the sheath to remain inside the shield once inserted therein, throughout 5 all subsequent normal uses of the hypodermic syringe assembly.

If desired, the retention members may be oriented in a plurality of specific longitudinal positions within the chamber of the shield, to allow the shield to be used in 10 conjunction with a plurality of different sizes (e.g. various lengths) of sheath/needle cannula sub-assemblies of hypodermic syringe assemblies. Each retention member, or set of retention members, may be located in the chamber of the shield so as to allow a particular shield to be usable 15 on a variety of sheath/needle cannula lengths.

In one preferred method of manufacture of a needle shield in accordance with the principles of the present invention, the housing of the shield may be formed along with the elongate channel therein in a single operation 20 step, such as by injection molding or the like. Subsequently, in a second operational step, a piercing tool is pushed through the housing into the chamber in at least one location. The piercing tool operates to shear a portion of the housing away from the remainder thereof as it is pushed 25 through, and causes the sheared portion to protrude into the chamber. The piercing tool may be sized and shaped so as to generate a sheared portion of the housing which is of a predetermined size and shape so as to be usable without further modification, as a retention member to retain the 30 sheath.

If desired, the piercing tool may be oriented along the housing of the shield prior to its piercing thereof, in such a manner that the retention member formed by the piercing tool will be properly located and oriented within the cham-35 ber so that a sheath inserted into the chamber can easily slide past the retention member while moving in the direction of insertion and become engaged and entrapped by the ■ H 0 4 PATENTS-^ -f S-7858 retention member so as to inhibit or prevent any attempt at extraction of the sheath.

In a preferred method of use of the present invention, a syringe assembly, such as a prepackaged, sterile, prefill-5 ed syringe assembly which includes a sheath/needle cannula sub-assembly, can be removed from its sterile packaging (if necessary) by a medical worker, and a shield formed in accordance with the principles of the present invention, taken from its own prepackaged sterile container (if neces-10 sary), can be slid over the sheath/needle sub-assembly. Due to the various possible locations of retention members within the chamber of the shield, the sheath/needle cannula sub-assembly need be of no specific length to be properly accommodated within the chamber of the shield and adequately 15 retained therein against extraction. When it is desired to use the hypodermic syringe assembly, the medical worker need merely remove the shield from the syringe assembly, which simultaneously, due to the inter-engagement of the shield and the sheath, removes the shield from the needle cannula. 20 After use of the syringe assembly, the shield, along with the sheath therein, can be repositioned over the needle cannula if desired without the fear of needle sticks occurring due to accidental piercing of the sheath by the needle cannula during reinsertion thereof.

The needle shield of the present invention may option ally be formed with the chamber having an open or closed distal end, and/or may optionally include stopper elements in the chamber at the distal end thereof for preventing over insertion of the sheath.

These and other objects and advantages of the present invention will become apparent from the following more detailed description when taken in conjunction with the accompanying drawings in which like elements are identified with like numerals throughout.

PATENfi ' S-7858 BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of a preferred embodiment of a needle shield formed in accordance with the principles of the present invention, affixed to a prefilled 5 hypodermic syringe assembly; Figure 2 is a side elevation view of the needle shield of Figure 1 made in accordance with the principles of the present invention, affixed over the sheath/needle cannula sub-assembly portion of the prefilled hypodermic syringe 10 assembly; Figure 3 is a longitudinal cross-sectional view of the needle shield and sheath/needle cannula sub-assembly of Figure 2 taken along line III—III of Figure 2; Figure 4 is a perpendicular cross-sectional view of the 15 needle shield and sheath/needle cannula sub-assembly of Figure 2 taken along line IV—IV of Figure 2; Figure 5 is an enlarged view of the middle portion of the shield of the present invention shown in the area of V of Figure 3; Figure 6 is an expanded cross-sectional view of a second preferred embodiment of the needle shield of the invention, and the sheath/needle cannula sub-assembly of Figure 3; Figure 7 is a cross-sectional view of the second pre-25 ferred embodiment of the needle shield formed in accordance with the principles of the present invention, being used with an alternative type sheath/needle cannula sub-assembly; and Figure 8 is a longitudinal cross-sectional view of a 30 third preferred embodiment of a needle shield formed in accordance with principles of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In the exemplary drawings, used for the purposes of illustration, an embodiment of a needle shield made in 11 24 ra accordance with the principles of the present invention is referred to generally by the reference numeral 10. The shield 10 is provided for use with the prefilled hypodermic syringe assembly 11 in order to prevent needle sticks to a 5 medical worker from needle cannula 12.

As best shown in Figures 1-3, the'prefilled hypodermic syringe assembly 11 generally includes a needle cannula 12 affixed by hub 13 to a syringe barrel 14. The barrel 14, commonly made of transparent glass, contains a fluid medica-10 ment 15 which is trapped therein by piston 16.

The needle cannula 12 is formed with a lumen 17 extending through the entire length thereof, and includes a distal opening 18 adjacent its beveled distal tip 19. A proximal opening 20 of the needle cannula 12 is in fluid communica-15 tion with the lumen 17 and the interior of the barrel 14.

The needle cannula 12 is affixed to the barrel 14 by hub 13. The hub 13 forms a distal cylindrical surface 21, an intermediate cylindrical surface 22, and a proximal cylindrical surface *23, each of which function to allow a 20 friction fit of the hub 13 with other elements of the syringe assembly 11 in a manner as will be further explained below. The hub 13 also includes cavity 24 through which the needle cannula 12 passes, and an abutment shoulder 47.

The barrel 14 of the syringe assembly 11 is preferably 25 formed of a transparent glass sidewall 25 of cylindrical shape which includes a closed tip 26 at the distal end thereof. The tip 26 is affixed in fluid tight permanent connection to cavity 24 of the hub 13. Tip 26 also includes a channel 27 through which the needle cannula 12 passes. 30 The needle cannula 12 is permanently affixed to the channel 27 in any well known fluid-tight manner. During use of the hypodermic assembly 11, the fluid medicament 15 is forced through opening 20 of the lumen 17 of the needle cannula 12, by forcing piston 16 in a distal direction in barrel 14. 35 Prior to movement of piston 16, a piston arm (not shown) can be readily attached to threaded extension 28 thereof for convenience in operating the piston 16. 12 As best shown in Figures 3 and 6, the sheath 29 is formed of a elongate cylindrical plug 30 of resilient material, such as rubber, and includes a cavity 31 sized to accept the needle cannula 12 therein. The proximal portion 5 32 of cavity 31 is sized to allow its retention over cylindrical surface 21 of the hub 13 in a friction fit connection. The proximal end surface 33 of the sheath 29 which surrounds opening 32 is intended to be placed in abutting relationship with the shoulder 47 of the hub 13 when the 10 sheath 29 is properly positioned thereon.

The distal portion 34 of cavity 31 is formed of a reduced diameter which is equal to, or only slightly greater, than the outer diameter of needle cannula 12. When the needle cannula 12 is properly inserted in the sheath 29, the 15 distal end 35 of the sheath 29 (which forms distal portion 34 of the cavity 31), effectively seals the distal opening 18 of the lumen 17 and substantially retains the fluid medicament 15 within the confined area of the barrel 14 and the lumen 17.

An alternative embodiment (not shown) of the sheath 29 may include forming the cavity 31 such that no distal portion 34 thereof exists. In other words, instead of cavity 31 extending from proximal opening 32 in a distal direction in a gradually reducing diameter through distal portion 34 25 at the distal end 35 thereof, the cavity 31 stops well short of the distal end 35 leaving the remainder of the distal end of the sheath 29 uniformly formed of resilient material. A needle cannula 12 inserted into this alternative type sheath 29 pass through the cavity 31 and pierces into the 3 0 distal end 35 of sheath 29 until the lumen opening 18 thereof is completely embedded in the resilient material forming distal end 35 (and until the opening 32 and proximal end surface 33 become properly positioned on the hub 13 in the manner as explained above). Since the lumen opening 18 of 35 the needle cannula 12 is completely embedded within the resilient material forming the sheath 29, the fluid medica- 13 S-7858 ment 15 is therefore completely sealed with barrel 14 and lumen 17.

As far as the needle shield of the present invention is concerned, either design of sheath 29, including sheaths 5 having other types of inner cavities 31 designed for sealing the distal opening 18 of a needle cannula 12, are hereby noted as being compatible for use with the needle shield 10 of the present invention. The needle sheath 29 as shown herein is intended to be only exemplary of the types of 10 needle sheaths which can be accommodated by the needle shield 10 of the present invention.

As referred to in this disclosure, the above-described hypodermic syringe assembly 11 is intended to be understood as describing the needle cannula 12, hub 13, barrel 14 and 15 sheath 29. Further as referred to herein, the sheath/needle cannula sub-assembly is intended to identify the portion of assembly 11 which includes sheath 29 and needle cannula 12.

As best shown in Figure 3, the needle shield 10 of the present invention may include a generally elongate cylindri-20 cally-shaped housing 36 formed of a relatively rigid material so as to be generally impermeable to penetration by the needle cannula 12. Any common well-known metal or polymeric material exhibiting these characteristics may be used, the preferred embodiment of the present invention being formed 25 of polypropylene.

The housing 36 of the shield 10 has formed therein an elongate generally cylindrical chamber 37. The chamber 37 is formed with at least a proximal end opening 38 through which the sheath/needle cannula sub-assembly can be insert-30 ed.

If desired, although not required by the present invention, a distal end closure 39 may be formed to close the distal end of the chamber 37. If present, the distal end closure 39 can function to prevent over insertion of a 35 sheath 29 within chamber 37, by functioning as a stop against which distal end 35 of the sheath 29 must ultimately abut when completely inserted into chamber 37. Alternative- 14 PATEN S-7858 ly, the distal end of chamber 37 may be left open, i.e., formed without distal end closure 39, and stopping members 46 may be formed therein to function as stops for preventing the distal end 35 of sheath 29 from passing therebeyond 5 during insertion. It should be well noted that stops 46 and/or distal end closure 39, are both optional structural features of the shield 10 of the present invention and may be used together, singly, or not at all, as desired.

The open end 38 of chamber 37 may include a flange 40 10 extending around the entire circumference thereof to protect the medical worker's hand during operation of the shield 10. The flange 40 may be of any radial dimension desired depending on the particular intended use of the shield 10, and the degree of user safety required. For example, should it be a 15 routine necessity after a particular use of the present invention that the shield 10 be re-inserted over a used needle cannula 12, the flange 40 may be formed of a generally large radial diameter in order to increase protection to the worker's hand in case of inadvertent misalignment of the 20 needle cannula 12 with proximal end opening 38 of the shield 10 during re-insertion. -If however, the shield 10 is intended to be used only for protection during storage and prior to use of the syringe assembly 11, the flange 40 may be of the smaller radial diameter (as shown in the drawings) 25 or may be omitted entirely from the shield 10, as desired.

As best shown in Figure 3, the interior surface 41 of chamber 37 is generally cylindrical in shape and sized to a diameter which is intended to be slightly larger than the diameter of the exterior surface 49 of the sheath 29. At at 30 least one location on interior surface 41, a retention member 42 protrudes therefrom into the chamber 37. Further, the retention member 42 is designed so as to contact the exterior surface 49 of the sheath 29 when the sheath is inserted into the chamber 37. The retention member 42 is 35 designed to allow it to slide over sheath surface 49 as long as the sheath 29 is moving in the direction of insertion into chamber 37. However, once sheath 29 has been inserted t ATONIES S-7858 beyond the retention member 42, attempted extraction of the sheath 29 causes the retention member 42 to increase its frictional force against surface 49 in an amount proportional to the force being used in extracting the sheath 29 from 5 the chamber 37. In other words, force used to attempt an extraction of the sheath 29 from chamber 37 is opposed by the retention member 42. Increases in the retraction force are subsequently opposed by an increase in the gripping force of the retention member 42 against the sheath surface 10 49. Thus, removal of the sheath 29 once inserted into the shield 10 beyond the retention member 42 is inhibited or substantially prevented.

In the particular embodiment of the shield 10 as shown in Figures 1-5 and in the second preferred embodiment as 15 shown in Figures 6 and 7, the retention member 42 is formed directly from the sidewall 3 6 of the shield 10 by piercing the sidewall 36 with a tool (not shown) designed to shear a section of the sidewall 36 away from the remainder thereof, and bend the sheared section (42) into the chamber 37. The 20 tool pierces an opening 43 in the sidewall 36 and forms the retention member 42 within the chamber 37.

The retention member 42 comprises a surface 44 (which previously was part of interior surface 41) and a sheared end surface 45 (which previously was part of sidewall 36). 25 As best shown in Figures 3 through 5, the retention member 42 takes the form of a barb and includes the surface 44 which will make initial contact with the surface 49 of sheath 29 as it is inserted into the chamber 37. Insertion of sheath 29 into chamber 37 causes sheath surface 49 to 30 force retention member 42 at least back (at least partially) into opening 43 and allows the sheath to slide therepast. However, when sheath 29 is subjected to extraction forces, a slight movement of the surface 49 thereof will cause the sheared end surface 45 of the retention member 42 to be 35 drawn in toward the sheath 29, thus increasing the resistance of the retention member 42 against the movement of the 16 PAINTS S-7858 sheath 29 to inhibit and subsequently prevent extraction of the sheath 29.

The retention member 42 may be used alone or in conjunction with other retention members. For example, simi- . larly formed and uniformly spaced retention members 42 may be located at positions around the chamber surface 41 to increase the gripping performance thereof during use. For example, as best shown in Figure 4, a particular useful orientation of a plurality of retention members 42 would be 10 to locate a plurality of retention members 42 in uniformly spaced apart locations around a single circumferential position in the chamber 37. Such a grouping of retention members 42 (identified hereinafter as a "set" of retention members) could be placed in chamber 37 at a location prede-15 termined to be useful in retaining a particular length or lengths of sheath 29. Further if desired, as shown in the second preferred embodiment of the present invention in Figures 6 and 7, a plurality of sets of retention members 42 may be positioned along the longitudinal axis of the shield 20 10 in order to adapt the shield 10 for use with more than one size of sheath/needle cannula sub-assembly.

Particularly, as shown in Figure 7, a relatively short needle cannula 12' covered by a relatively short sheath 29' may be engaged by a set of retention members 42 which are 25 located toward the proximal end opening 38 of the shield 10. The shield 10 may be manufactured with a secondary set of retention members 42 located closer to the distal end of the shield 10, in order to allow the single shield 10 to be used on any of a number of lengths of sheath/needle cannula sub-30 assemblies. In either of the first or second preferred embodiment of the present invention it is clear that a "generic" shield 10 can be manufactured and subsequently used to retrofit a plurality of various sizes or lengths of sheath/needle cannula sub-assemblies of various prefilled 35 hypodermic syringe assembly designs (which of course may be similar to or very different from the syringe assembly 11 shown in the drawings). 17 PATENTS S-7858 The shield 10 of the present invention as shown in Figures l through 7 can be manufactured in a plurality of ways. One of the preferred methods of manufacturing the present invention is to form the housing 36 with chamber 37 5 therein in a single manufacturing process such as injection molding. As stated above, the housing 36 will include an open proximal end 38 formed as a part of channel 37, (opening 38 having generally the same diameter as the interior surface 41). The housing 36 may optionally include flange 10 40, closed end 39, stop elements 46 and reinforcement ribs 48, all formed integrally therewith as desired.

In a second manufacturing process, the shield 10 is then pierced in any one of a number of predetermined locations to form openings 43 in the housing 36 and to cause 15 retention member 42 to protrude into chamber 37. The piercing process and the tool used therefor, can be chosen to form the appropriate size and protrusion of retention members 42 for proper functioning of the shield during insertion and retention of the sheath 29 therein. For example, a 2 0 shield 10 having a cylindrical chamber 37 with an interior diameter of approximately 0.20 inches (0.50cm), may be formed with a retention member 42 therein which effective reduce the diameter through which the sheath 29 must pass to approximately 0.15 inches (0.38cm). A sheath 29 having an 25 outer diameter of approximately 0.19 inches (0.48cm) would therefore be required to contact surface 44 of the retention member 42 to force it to move somewhat toward the interior surface 41 of the chamber 37 to allow the sheath 29 to move therepast into a completely inserted position within chamber 30 37. Once the sheath 29 is inserted, the sheared end surfaces 45 of the retention members 42 is locked in intimate contact with surface 49 of the sheath 29, and any subsequent extraction force of the sheath 29 would be immediately opposed by surfaces 45 to prevent any substantial retractio-35 nal movement of the sheath 29.

The shield 10 of the present invention is very simple and reliable in use. For example, a medical worker can 18 24*15MA S-7858 merely insert the sheath/needle cannula sub-assembly of a hypodermic syringe assembly 11 into the shield 10 at any time prior to its use. If desired, the hypodermic syringe assembly 11 may be manufactured as a unit and packaged 5 singly or in quantities, separated apart from the shield 10. The shield 10 may be similarly packaged separately from the syringe 11, either singly or in quantities. A medical worker would then perform the retrofit procedure him or herself by removing an assembly 11 from its sterile package 10 and a shield 10 from its package and retrofitting the shield 10 thereto by inserting the sheath/needle cannula sub-assembly completely into the chamber 37 of the shield 10. In this manner, the sterility of the needle cannula 12 is unaffected by the retrofit procedure, and the assembly 11 is 15 made substantially safe from inadvertent needle sticks which may have resulted from bumping or applying excessive pressure to the distal end 35 of the sheath 29 prior to the positioning of the shield 10 thereover.

When it is desired to use the syringe assembly 11 to 20 deliver the medication 15 therein to a patient, the medical worker can remove shield 10 from the assembly 11. Removal of shield 10 simultaneously causes the removal of sheath 29 therewith, thus exposing the needle for use. A piston arm (not shown) can be attached to threaded end 28 of the piston 25 16 if desired, and the medical worker can then administer the medication 15 to the patient.

After use, should it be necessary for the medical worker to reinsert the needle cannula 12 into the sheath 29, the medical worker is substantially protected from a needle 30 stick due to the type of misalignment of the needle cannula 12 in the sheath 29 which would cause tip 19 thereof to prematurely penetrate the plug material 30 and "skive" off from its intended path and protrude through the exterior surface 49. Should such occur, instead of the medical 35 worker receiving a stick from the tip 19 of the needle cannula 12, the tip 19 becomes embedded in the substantially impermeable housing 36 of the shield 10 and is prevented 19 from reaching the medical workers hand which is holding the shield 10.

As best shown in Figure 8, an alternative embodiment of . the present invention is shown as shield 10'. Shield 10' is 5 substantially similar to shield 10 of the first preferred embodiment herein except that the retention members 42' have been formed as a part of the molding process of the housing 36' instead of in a secondary manufacturing step.

It will be apparent from the forgoing, while particular 10 embodiments have been illustrated and described, various modifications can be made thereto without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Claims (56)

2H& S-7858 CE&fHS WHAT^WE CLAIM IS:-2-S QiAHiBP'

1. A shield for a hypodermic syringe assembly which includes a sheath/needle sub-assembly having a resilient sheath covering a distal portion of a needle cannula, said shield comprising: 5 a relatively rigid housing forming an elongate chamber therein, said chamber forming an open proximal end, and said chamber and said open proximal end having cross-sectional areas sized to allow the sheath/needle sub-assembly to be inserted through said open proximal end and into said cham-10 ber; and retention means formed as a part of said housing and located in said chamber away from said open proximal end, for holding the sheath in said chamber and for preventing separation of the sheath from said shield when the needle 15 cannula is removed from the sheath; whereby said shield is easily positionable over the sheath/needle sub-assembly, and the sheath, when engaged within said shield, is easily removed from the needle cannula by removing said shield.

2. A shield according to claim 1 wherein said retention means forms an effective cross-sectional area of said chamber which is less than the cross-sectional area of the sheath.

3. A shield according to claim 2 wherein said retention means includes at least one retention member projecting into said chamber and functioning to allow movement of the sheath/needle sub-assembly into said chamber and subsequent-5 ly to inhibit movement of the sheath out of said chamber. 21 S-7858

4. A shield according to claim 3 wherein said at least one retention member is relatively resilient when subjected to forces thereagainst caused by the sheath/needle subassembly as it is inserted into said shield, and relatively 5 rigid when subjected to forces thereagainst caused by the sheath during attempted retraction thereof from said shield.

5. A shield according to claim 4 wherein said at least one retention member includes a sliding surface and a barbed end, said sliding surface contacting the sheath during insertion thereof, and said barbed end gripping and retain- 5 ing the sheath against subsequent attempts to retract the sheath from said chamber.

6. A shield according to claim 5 wherein said at least one retention member is located directly adjacent to. and partially forms an opening extending through said housing into said chamber.

7. A shield according to any one of the preceding claims wherein said housing is formed of a substantially cylindrical outer surface and said chamber is formed of a substantially cylindrical inner surface.

8. A shield according to claim 7 wherein said housing includes a plurality of reinforcement ribs integrally formed with and extending longitudinally along said cylindrical outer surface of said housing.

9. A shield according to claim 6 wherein said opening formed at least partially by said at least one retention member is located between at least two of said plurality of reinforcement ribs.

10. A shield according to claim 3 including a plurality of said retention members, said plurality--of retention 22 24 1 5 9 4 -D7i mt?V7rnc PATENTS S-7858 members forming at least one set of retention members spaced uniformly about a circumference of said chamber.

11. A shield according to claim 10 including at least two of said sets of retention members, each of said sets being located at a different longitudinal position along said chamber, whereby said shield is adapted to receive and retain sheath/needle sub-assemblies of varying lengths.

12. A shield according to claim 2 wherein said cross-sectional area of said chamber is a circular area and said effective cross-sectional area is an effective circular area formed by said retention means.

13. A shield according to claim 12 wherein said circular area is approximately 0.20 inches (0.50cm) in diameter and said effective circular area is approximately 0.15 inches (0.38cm) in diameter.

14. A shield according to any one of the preceding claims wherein said chamber further includes a closed distal end.

15. A shield according to claim 14 further including stop means located adjacent said distal end of said chamber, for abutment against a distal end of the sheath to prevent insertion of the sheath beyond said stop means.

16. A shield according to claim 15 wherein said closed distal end of said chamber comprises a plug means affixed to said housing, said stop means being integrally formed with said plug means.

17. A shield according to claim l wherein said housing is formed of a substantially, cylindrical' outer surface and said chamber is formed of a substantially cylindrical irmer--;ii53aa^ 23 24 1 59 4 PATENTS S-7858

18. A shield according to claim 17 wherein said cylindrical outer surface includes a plurality of reinforcement ribs integrally formed with and extending longitudinally along said cylindrical outer surface of said housing.

19. A shield according to any one of the preceding claims further including flange means integrally formed with and extending radially outward from said housing at a location adjacent said open proximal end of said chamber.

20. A shield according to any one of the preceding claims made from polypropylene.

21. A shield according to any one of the preceding claims wherein said chamber includes an open distal end.

22. A shield according to claim 21 further including stop means located in said chamber adjacent said opened distal end, for abutment with a distal end of the sheath for preventing insertion of the sheath beyond said stop means.

23. A shield according to claim 22 wherein said stop means is integrally formed with said housing and extends into said chamber at a location adjacent said open distal end.

24. A method of using a shield for a hypodermic syringe assembly which includes a sheath/needle sub-assembly having a resilient sheath covering the distal portion of a needle cannula, said shield including a relatively rigid 5 housing forming an elongate chamber therein, the chamber having an open proximal end and a retention means including at least one retention member located away from the chamber open end formed as a part of the housing, for holding the sheath within the chamber and for preventing separation of 10 the sheath from the chamber when the needle canijtfl-a1 is V. • "... ; f; v _ < '"^20JAN»9»;|. 24 \ / 24 1 5 PATENTS S-7858 removed, said method of using the shield comprising the steps of: inserting the sheath/needle sub-assembly through the open proximal end of the chamber until the sheath engages 15 with the retention means; removing the sheath from the needle cannula by removing the shield while the retention means holds the sheath in place therein.

25. A method according to claim 24 further including the step of: replacing the sheath with the shield affixed thereabout, over the needle cannula.

26. A method according to claim 25 further including the step of: removing the hypodermic syringe assembly from a sterile package prior to inserting the sheath/needle sub-assembly 5 thereof into the shield.

27. A method according to claim 24 wherein the retention means includes at least one retention member projecting into the chamber and said step of inserting the needle/sheath sub-assembly until the sheath engages with the 5 retention means includes engaging the sheath with the at least one retention member, the retention member functioning to allow movement of the sheath/needle sub-assembly into the chamber, and said step of removing the sheath from the needle cannula includes at least one retention member func-10 tioning to inhibit movement of the sheath out of the chamber.

28. A method according to claim 27 wherein the shield includes a plurality of retention members forming at least two sets of retention members, each set of retention members including a plurality of retention members spaced uniformly 5 about a circumference of the chamber and each set of reten- 25 PATENTS S-7858 tion members is located at a different longitudinal position along the chamber, said step of inserting the sheath/needle sub-assembly into the chamber further includes engaging at least one of the sets of retention members with the sheath.

29. A method according to claim 28 wherein said step of engaging the sheath with the retention members includes engaging said sheath with only one set of retention members.

30. A method according to claim 28 wherein said step of engaging the sheath with the retention members includes engaging the sheath with at least two sets of retention members.

31. A method according to claim 24 wherein the chamber is cylindrical in shape having a circular cross-sectional area through which the sheath must pass during insertion, and the retention means forms an effective cross-sectional 5 area which is less than the cross-sectional area of the chamber and less than the cross-sectional area of the sheath, said step of inserting the sheath/needle sub-assem-bly into the chamber further includes the step of resilient-ly deforming the sheath as it passes beyond the retention 10 means during insertion thereof into the chamber.

32. A method according to claim 31 wherein the retention members are relatively resilient when subjected to forces thereagainst caused by the sheath/needle sub-assembly as it is inserted into the shield and relatively rigid when 5 subjected to forces thereagainst caused by the sheath during attempted retraction thereof from the shield, the retention members including a sliding surface and a barbed end, said step of insertion further including contacting the sheath and the sliding surface of the retention members during 10 insertion of the sheath into the chamber, and contacting the sheath with the barbed end of the retention members and 26 S-7858 gripping and retaining the sheath against subsequent attempts to retract the sheath from the chamber. 27 2 4 15J 4 S-7858

33. A method according to claim 24 wherein the shield further includes stop means located adjacent the distal end of the chamber and said method further includes the step of abutting a distal end of the sheath against the stop means 5 at the completion of said inserting step, the stop means functioning to prevent further insertion of the sheath into the chamber beyond the stop means.

34. A method of making a shield for a hypodermic syringe assembly which includes a sheath/needle sub-assembly having a resilient sheath covering a distal portion of a needle cannula, said method of making the shield comprising 5 the steps of: forming a relatively rigid housing with an elongate chamber therein, with the chamber being formed with an open proximal end, the open proximal end of the chamber being formed to a size sufficient to allow the sheath/needle sub-10 assembly to be insertable therethrough into the chamber; and forming a retention means in the chamber away from the open proximal end for retaining the sheath within the chamber when the shield is positioned thereover.

35. A method according to claim 34 wherein the step of forming a retention means includes forming at least one retention member which projects into the chamber.

36. A method according to claim 35 wherein said step of forming at least one retention member includes forming a plurality of retention members which comprise a set of retention members which are spaced uniformly about a circum- 5 ference of the chamber.

37. A method according to claim 36 wherein said step of forming at least one set of retention members further includes forming two sets of retention members, each set being located at a different longitudinal position along the 5 chamber. 28 patents S-7858

38. A method according to claim 34 wherein said step of forming a relatively rigid housing with an elongate chamber therein includes forming the chamber into a generally cylindrical shape.

39. A method according to claim 38 wherein said step of forming the chamber into a cylindrical shape includes forming the chamber to a diameter of approximately 0.20 inches (0.50cm), and said step of forming a retention means in the chamber includes forming the retention means within the chamber which have an effective cross-sectional diameter of approximately 0.15 inches (0.38cm).

40. A method according to claim 34 wherein said step of forming a retention means includes forming at least one retention member which is relatively resilient when subject to forces thereagainst caused by the sheath/needle subassembly as it is inserted into the shield and relatively rigid when subjected to forces thereagainst caused by the sheath during attempted retraction thereof from the shield.

41. A method according to claim 40 wherein said step of forming at least one retention member includes forming a sliding surface and a barbed end on at least one retention member whereby the sliding surface can contact the sheath during insertion thereof and the barbed end can grip and retain the sheath against subsequent attempts to retract the sheath from the chamber.

42. A method according to claim 34 wherein said step of forming a relatively rigid housing includes forming a closed distal end in the elongated chamber formed by the housing.

43. A method according to claim 34 wherein said step of forming a relatively rigid housing with an elongate chamber therein further includes forming stop means within 29 24 1594 PATENTS S-7858 the elongated chamber whereby a stop means can contact a distal end of a sheath when inserted into the chamber and prevent insertion of the sheath beyond the stop means.

44. A method according to claim 42 wherein said step of forming a relatively rigid housing with an elongate chamber includes forming a plug means to close a distal end of a chamber, and further includes forming stop means integrally with the plug means, for contact of a distal end of a sheath to prevent insertion of the sheath beyond the stop means.

45. A method according to claim 34 further including the step of forming flange means integrally with, and extending radially outward from, the housing at a location adjacent the open proximal end of the chamber.

46. A method according to claim 34 wherein the shield is formed from polypropylene.

47. A method according to claim 34 wherein said step of forming an elongate chamber within the relatively rigid housing includes forming the chamber with an open distal end.

48. A method according to claim 47 including the further steps of a plug means sized to cover the open distal end of the chamber, said step of forming the plug means including forming stop means integrally covering the open distal end of the chamber with the plug means such that the stop means are located within the chamber.

49. A method according to claim 34 wherein said step of forming a retention means includes forming at least one retention member by piercing through the housing of the shield into the chamber thereof to force a portion of the housing into the chamber to form the retention member. 30 4 S-7858

50. A method according to claim 49 wherein said step of forming a relatively rigid housing includes forming the housing of a generally cylindrical outer surface and forming the chamber of a generally cylindrical inner surface, and 5 forming a plurality of reinforcement ribs integrally with, and extending longitudinally along, the cylindrical outer surface of the housing.

51. A method according to claim 49 wherein said step of piercing the housing to form a retention member includes piercing the housing in a plurality of locations to form a plurality of retention members.

52. A method according to claim 51 wherein the step of forming a plurality of retention members includes forming at least one set of retention members circumferentially about the chamber wall in uniform spaced apart relationship.

53. A method according to claim 52 wherein said step of forming a plurality of retention members includes forming the retention members in between the reinforcement ribs.

54. A shield for insertion over and retention of a sheath of a hypodermic syringe assembly which has been formed by a method as claimed in any one of claims 34-53.

55. A shield as claimed in claim 1, substantially as herein described with reference to any one of the Drawings.

56. A method as claimed in claim 24, substantially as herein described with reference to any one of the Drawings. AMERICAN HOME PRODUCTS CORPORATION By Their^?orneys BALDWIN SON & CAREY ^ \ FEB