|Publication number||USRE36447 E|
|Application number||US 09/116,445|
|Publication date||Dec 14, 1999|
|Filing date||Jul 16, 1998|
|Priority date||Jul 29, 1985|
|Publication number||09116445, 116445, US RE36447 E, US RE36447E, US-E-RE36447, USRE36447 E, USRE36447E|
|Inventors||Phillip O. Byrne, Penelope R. Seiders, Harry R. Ingham|
|Original Assignee||Btg International Limited|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (44), Referenced by (31), Classifications (9), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This is a continuation of Ser. No. 08/160,859 filed Dec. 3, 1993, .Iadd.(now U.S. Pat. No. 5,601,535), .Iaddend.which is a continuation of Ser. No. 07/709,999 filed Jun. 4, 1991, .Iadd.(now abandoned), .Iaddend.which a continuation of Ser. No. 07/595,664 filed Oct. 11, 1990 (now U.S. Pat. No. 5,084,030), which is a continuation of Ser. No. 07/241,256 filed Sep. 7, 1988 (now abandoned), which is a continuation of Ser. No. 06/888,376 filed Jul. 23, 1986 (now U.S. Pat. No. 4,826,490).
The present invention is a safety device for a hypodermic needle or similar instrument used in the clinical puncture of the skin.
The taking of blood samples from persons in hospitals, health centres or other clinical areas is a routine medical procedure, as is the injection of pharmaceutical preparations of biological materials. However, many incidents have been reported in the press and in medical journals of clinical operators subsequently accidentally wounding themselves or other persons with the needle and thereby either transmitting a disease or causing chemical or biological poisoning.
There is a clear need for a device which permits the disposal of a hypodermic needle or such instrument in a manner which protects the clinical operator, observers of the clinical procedure and all other persons concerned, including the general public, from accidental wounding.
It is an object of the present invention to provide such a device.
The safety device according to the invention for a hypodermic needle or similar instrument comprises a sheath, adapted to be connected to said needle or other instrument or to a support therefor in a first position which permits normal use of said needle or other instrument and to be placeable, by movement relative to the needle or other instrument or by folding upon itself, in a second position in which the needle or other instrument is encapsulated by the sheath and the sheath is retained in that second position.
As indicated, the safety device of the present invention is generally applicable to the protection of puncturing instruments typified by hypodermic needles, although among such instruments hypodermic needles are by far the most widely used. For example, the device may be applied to the protection of biopsy needles, winged needles, that is needles provided with lateral attachments to enable them to be affixed to the skin surface as by adhesive tape, and to intravenous cannulas and lumbar puncture needles. For convenience, the invention is hereinafter described specifically as applied to "needles", in particular hypodermic needles, but it is emphasised that the invention is not to be limited thereby.
The sheath is adapted to be attached to the needle or to a support for the needle but may be provided separately from the needle, to be attached to the needle or support at the point of use, either before or after the needle has actually been used. It is much preferred that such separate sheaths be attached before use, so that the needle may be more readily encapsulated immediately after it has been used. However, the sheath according to the present invention is preferably and conveniently supplied already attached to the needle. In particular, it is preferably attached either irremovably or in a way which makes its removal difficult. For example, the sheath may be adhered to the needle or to a support for the needle or may be clipped to the needle or support.
When the needle is designed for use without a syringe or remote from an associated syringe, to which it is then linked by a flexible tube, then the sheath is preferably secured direct to the needle. The sheath may then conveniently incorporate one or more parts which are foldable relative to the body of the sheath and thereby to encapsulate the needle.
When the needle, on the other hand, is mounted upon a housing designed to be attached to a syringe barrel or luer connector, then the sheath may advantageously be secured to the housing. The sheath may then be capable of movement relative to the housing in a direction which has a component parallel to the length of the needle, so that the sheath may be moved along the length of the needle until the latter is fully encapsulated. This relative movement of sheath and housing may for example be a linear sliding movement or a spiral movement, as more particularly exemplified hereinafter in FIGS. .[.3A.]. .Iadd.2A .Iaddend.and .[.3B.]. .Iadd.5A .Iaddend.of the drawings.
Such relative movement of sheath and housing may be determined by one or more linear or spiral grooves or channels in the housing engaging one or more lugs or other projections on the sheath--or grooves or channels in the sheath engaging projections on the housing.
In the second position of the sheath, in which the needle is encapsulated, the sheath is retained against further movement relative to the needle. That retaining of the sheath is preferably irreversible or reversible only with difficulty. For example, one or more lugs or other projections on one of the relatively movable components may engage one or more apertures or slots in the other component, preferably under the pressure of a natural resilience in at least one of the components or under pressure from one or more springs.
The sheath may advantageously and conveniently be made from a resilient plastics material, for example polypropylene, and the housing may be made from the same, or a similar, material.
The invention will now be further described with reference to the accompanying drawings, wherein:
FIG. 1A is a sectional view of a first embodiment of the safety device according to the present invention, in a position in which the needle may be used normally;
FIG. 1B is an enlarged detailed view of the circled portion of FIG. 1A;
FIG. 2A is a view corresponding to that of FIG. 1A but with the sheath moved to encapsulate the needle;
FIG. 2B is an enlarged detailed view of the circled portion of FIG. 2A;
FIG. 3 is a sectional view of a second embodiment of the safety device according to the present invention, in a position in which the needle may be used normally;
FIG. 4A is a view corresponding to that of FIG. 3 but with the sheath folded to encapsulate the needle;
FIG. 4B is an enlarged view of the circled portion of FIG. 4A;
FIG. 4C is a plan view of the device in the position shown in FIG. 4A;
FIG. 5A is a view, partly in section of a third embodiment of the safety device according to the present invention, in a position in which the needle may be used normally;
FIG. 5B is a view corresponding to that of FIG. 5A but with the sheath moved to encapsulate the needle;
FIG. 5C is an enlarged view of the circled portion of FIG. 5B.[...]..Iadd.;
New FIG. 6 is a view similar to FIG. 5B illustrating a further form of the guide slot and projection..Iaddend.
The embodiment of the invention shown in FIGS. 1A and 1B comprises a needle housing 4 in the form of a plastics moulding carrying a needle 5 and, slidably supported upon the housing 4, a plastics sheath 6 incorporating a thumb guard 7 integral therewith. .Iadd.The needle housing 4 thus comprises a hollow support structure and forms with needle 5 a sub-assembly..Iaddend.
Also incorporated in the housing 4 and running lengthwise, is a channel 8. The sheath 6 incorporates a self-springed spigot 9.Iadd., .Iaddend.which slides along the channel 8, as shown in more detail in the enlarged inset. When the sheath travels to the end of the channel 8, the self-springed spigot 9 drops into a small "well" 10, thus locking the sliding sheath in position. The length of the sheath is such that, when it is locked in position, the sharp end of the needle is completely enclosed by the sheath, as shown in FIG. 1B.
The housing 4 is designed to mate with any standard syringe barrel or luer connector. After use, the protective sheath is extended into the locked position, thus encapsulating the needle in a safe manner.
The embodiment of the invention shown in FIGS. .[.2A to 2C.]. .Iadd.3 and 4A-4C .Iaddend.is designed to allow encapsulation of a hypodermic needle 21 which is tethered to a syringe (not shown) by an extension tube 22. The needle 21 is sandwiched between two plastics mouldings or pressings 23,24 which together form a sheath 25. A part 26 of the sheath 25 is permanently attached to the hypodermic needle. At points 23a and 24a the plastic is formed in a manner which allows the free ends of members 23 and 24 to hinge as indicated. Near to its outer end, the member 23 carries two spigots 27, which are designed to mate with holes 28 in the member 24 (when the sheath is in its folded position) and lock the sheath securely around the needle 21.
The third embodiment of the invention, as illustrated in FIGS. .[.3A and 3B.]. .Iadd.5A-5C.Iaddend., comprises a needle housing 31 in the form of a plastics moulding, a plastics sheath 32 which is free to rotate thereon and a needle 33. Impressed into the housing 31 is helical groove 34 extending from near the end of the housing 31 which is distal to the needle 33 towards the needle. The sheath 32 has a self-springed spigot 35 which fits into, and is free to move along, the helical groove 34 .Iadd.while subject to a biasing force acting between the sheath 32 and housing 31 during relative movement of the sheath and housing.Iaddend.. As shown in FIG. .[.3B.]. .Iadd.5B.Iaddend., rotation of the sheath 32 in a clockwise direction (viewed from the rear) will result in a forward motion causing the sheath to encapsulate the needle 33. At the end of its travel the springed spigot 35 drops into a "well" 36 thereby locking the sheath in position. The length of the sheath 32 is such that when it has reached this locked position the needle is completely encapsulated and withdrawn beyond the orifice 37 in the outer end of the sheath.
The device shown in FIGS. .[.3A and 3B.]. .Iadd.5A-5C .Iaddend.is designed to mate with any standard syringe barrel or luer connector. .Iadd.For example, as illustrated in FIG. 2A, a connector formation is provided on an elongate body 40 including a tapered abutment surface 42 for mating with the needle support housing and having a complementary tapered abutment surface 44. .Iaddend.After use, the protective sheath is placed in position by applying a twisting force to the sheath. To facilitate the application of this twisting force, a raised section 38 may be incorporated into the sheath's surface.
This form of the invention may be fabricated with one or more helical grooves, which may extend in a clockwise or anti-clockwise direction. For greater mechanical strength and stability, a double helix may be preferred.
.Iadd.In FIG. 6, the groove 34a and spigot 35a are formed in the sheath 32a and housing 31a, respectively, i.e., reversed as previously described from the configuration of FIGS. 5A-5C..Iaddend.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US27797 *||Apr 10, 1860||Improvement in cultivator-teeth|
|US2876770 *||Oct 10, 1955||Mar 10, 1959||Raymond A White||Shielded hypodermic syringe|
|US2925083 *||Dec 27, 1957||Feb 16, 1960||Craig Clarence D||Hypodermic syringe with hood for guarding and concealing the needle|
|US3323523 *||Nov 18, 1964||Jun 6, 1967||Abbott Lab||Intravenous catheter assembly with divisible needle sheath portions|
|US3463152 *||Jun 8, 1966||Aug 26, 1969||Sorenson Research Corp||Catheter placement unit|
|US3536073 *||Jun 18, 1968||Oct 27, 1970||Baxter Laboratories Inc||Catheter placement apparatus|
|US3574306 *||Jan 13, 1969||Apr 13, 1971||Deseret Pharma||Needle protector|
|US3610240 *||Jun 13, 1967||Oct 5, 1971||American Hospital Supply Corp||Intravenous catheter apparatus with catheter telescoped inside puncturing cannula|
|US3658061 *||Nov 10, 1970||Apr 25, 1972||Baxter Laboratories Inc||Needle guard|
|US3884230 *||Sep 27, 1973||May 20, 1975||Goldwyn L Wulff||Flexible needle and guard device for a hypodermic syringe|
|US3890971 *||Oct 23, 1973||Jun 24, 1975||Mark Scott Hamilton||Safety syringe|
|US3904033 *||Nov 8, 1974||Sep 9, 1975||Xomox Corp||Pick-guard|
|US4170993 *||Mar 13, 1978||Oct 16, 1979||Marcial Alvarez||Sliding I.V. needle carrier assembly|
|US4425120 *||Apr 15, 1982||Jan 10, 1984||Sampson Norma A||Shielded hypodermic syringe|
|US4573976 *||May 24, 1984||Mar 4, 1986||Dolores A. Smith||Shielded needle|
|US4631057 *||Dec 17, 1985||Dec 23, 1986||Dolores A. Smith||Shielded needle|
|US4664259 *||Aug 29, 1986||May 12, 1987||Robert Landis||Needle container and method for preventing accidental contact with a needle|
|US4666435 *||May 22, 1986||May 19, 1987||Braginetz Paul A||Shielded medical syringe|
|US4693257 *||May 12, 1986||Sep 15, 1987||Markham Charles W||Needle aspiration biopsy device with enclosed fluid supply|
|US4695274 *||Jan 31, 1986||Sep 22, 1987||Fox Richard L||Protected hypodermic needle|
|US4743233 *||Dec 22, 1986||May 10, 1988||Schneider Medical Technologies, Inc.||Safety cap syringe|
|US4826490 *||Jul 23, 1986||May 2, 1989||National Research Development Corporation||Safety device for hypodermic needle or the like|
|US4931048 *||Oct 17, 1988||Jun 5, 1990||Icu Medical, Inc.||Medical device|
|US5084030 *||Oct 11, 1990||Jan 28, 1992||National Research Development Corporation||Safety device for hypodermic needle or the like|
|US5120320 *||Feb 13, 1991||Jun 9, 1992||Becton, Dickinson And Company||I.V. infusion or blood collection assembly with automatic safety feature|
|US5348544 *||Nov 24, 1993||Sep 20, 1994||Becton, Dickinson And Company||Single-handedly actuatable safety shield for needles|
|US5549572 *||May 5, 1995||Aug 27, 1996||British Technology Group, Ltd.||Safety device for hypodermic needle or the like|
|US5601535 *||Dec 3, 1993||Feb 11, 1997||British Technology Group Ltd.||Safety device for hypodermic needle or the like|
|USRE27797||Dec 14, 1970||Oct 30, 1973||Catheter placement unit|
|AU164214A *||Title not available|
|AU201484A *||Title not available|
|AU202213A *||Title not available|
|AU232255A *||Title not available|
|AU253057A *||Title not available|
|AU1373170A *||Title not available|
|AU2119148A *||Title not available|
|AU5755669A *||Title not available|
|DE813433C *||Nov 6, 1948||Sep 13, 1951||Oskar Dr Med Gleichmann||Vorrichtung fuer medizinische Injektionsspritzen|
|GB924734A *||Title not available|
|GB1233302A *||Title not available|
|GB1297746A *||Title not available|
|GB2059268A *||Title not available|
|GB2114006A *||Title not available|
|JPS494797A *||Title not available|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US6428517 *||Feb 17, 2000||Aug 6, 2002||Milestone Scientific, Inc.||Hand-piece for injection device with a retractable and rotating needle|
|US6623461||Mar 15, 2002||Sep 23, 2003||Becton, Dickinson And Company||Forward shielding safety device|
|US7060055||Jul 28, 2003||Jun 13, 2006||Becton Dickinson And Company||Forward shielding safety device|
|US7201740||Jul 1, 2004||Apr 10, 2007||Becton, Dickinson And Company||Forward-shielding blood collection set|
|US7226450 *||Oct 8, 2002||Jun 5, 2007||The Board Of Regents Of The University Of Texas Systems||Tissue penetrating device and methods for using same|
|US7985216||Mar 15, 2005||Jul 26, 2011||Dali Medical Devices Ltd.||Medicinal container engagement and automatic needle device|
|US8057431||Dec 20, 2007||Nov 15, 2011||B. Braun Melsungen Ag||Hinged cap for needle device|
|US8376998||Sep 15, 2004||Feb 19, 2013||Elcam Medical Agricultural Cooperative Association Ltd.||Automatic injection device|
|US8439870||Sep 8, 2009||May 14, 2013||B. Braun Medical Inc.||Safety needle assembly and methods|
|US8500690||Jul 1, 2005||Aug 6, 2013||Becton, Dickinson And Company||Passively shielding needle device|
|US8632503||Mar 13, 2009||Jan 21, 2014||Becton, Dickinson And Company||Safety pen needle assembly having shielding for patient and non-patient ends|
|US8715231||Nov 14, 2011||May 6, 2014||B. Braun Melsungen Ag||Hinged cap for needle device|
|US8801673||Mar 13, 2009||Aug 12, 2014||Becton Dickinson & Company||Safety pen needle assembly having shield for non-patient end|
|US8932264||Aug 11, 2003||Jan 13, 2015||Becton, Dickinson And Company||Medication delivery pen assembly with needle locking safety shield|
|US9162030||Dec 19, 2013||Oct 20, 2015||Becton, Dickinson And Company||Safety pen needle assembly having shielding for patient and non-patient ends|
|US9402964||Jun 26, 2013||Aug 2, 2016||Becton, Dickinson And Company||Passively shielding needle device|
|US9623194||Dec 9, 2014||Apr 18, 2017||Becton, Dickinson And Company||Passive safety pen needle assembly|
|US9642971||Mar 13, 2009||May 9, 2017||Becton, Dickinson And Company||Safety needle assembly|
|US9649452||Dec 9, 2014||May 16, 2017||Becton, Dickinson And Company||Active safety pen needle assembly|
|US20030114858 *||Oct 8, 2002||Jun 19, 2003||Athanasiou Kyriacos A.||Tissue penetrating device and methods for using same|
|US20040236287 *||May 23, 2003||Nov 25, 2004||Becton Dickinson & Company||Forward shielding medical needle device|
|US20060079847 *||Jul 1, 2004||Apr 13, 2006||Becton, Dickinson And Company||Forward-shielding blood collection set|
|US20080306452 *||Jul 1, 2005||Dec 11, 2008||Becton, Dickinson And Company||Passively Shielding Needle Device|
|US20090259201 *||Apr 15, 2008||Oct 15, 2009||Becton, Dickinson And Company||Flash Activated Passive Shielding Needle Assembly|
|USRE43473||Jan 9, 2008||Jun 12, 2012||Becton, Dickinson And Company||Needle safety device|
|EP2119464A1||Apr 15, 2009||Nov 18, 2009||Becton, Dickinson and Company, Wagner, Jaconda||Flash activated passive shielding needle assembly|
|EP2650033A2||Sep 15, 2004||Oct 16, 2013||Elcam Medical Agricultural Cooperative Association Ltd.||Automatic injection device|
|EP2705864A2||Jul 1, 2005||Mar 12, 2014||Becton, Dickinson and Company||Passively shielding needle device|
|EP2705865A2||Jul 1, 2005||Mar 12, 2014||Becton, Dickinson and Company||Passively shielding needle device|
|EP2910266A1||Apr 15, 2009||Aug 26, 2015||Becton Dickinson and Company||Flash acitvated passive shielding needle assembly|
|WO2005025637A2||Sep 15, 2004||Mar 24, 2005||Dali Medical Devices Ltd.||Automatic needle device|
|U.S. Classification||604/198, 604/263, 604/110|
|Cooperative Classification||A61M5/3216, A61M5/3272, A61M5/3271|
|European Classification||A61M5/32C2D, A61M5/32C2H5|
|Dec 22, 2003||FPAY||Fee payment|
Year of fee payment: 8
|Dec 21, 2007||FPAY||Fee payment|
Year of fee payment: 12
|May 22, 2014||AS||Assignment|
Owner name: BTG INTERNATIONAL LIMITED, UNITED KINGDOM
Free format text: CHANGE OF REGISTERED ADDRESS CERTIFICATE;ASSIGNOR:BTG INTERNATIONAL LIMITED;REEL/FRAME:033003/0996
Effective date: 20110628