Source: https://patents.google.com/patent/US8827961B2/en
Timestamp: 2019-07-21 20:03:12
Document Index: 331291185

Matched Legal Cases: ['art 2007', 'Application No. 200680006138', 'Application No. 03', 'Application No. 03', 'Application No. 2004212245', 'Application No. 200480006925', 'Application No. 6141', 'Application No. 09175295', 'Application No. 0621157', 'Application No. 200480006925']

US8827961B2 - Safety needle - Google Patents
US8827961B2
US8827961B2 US12/470,220 US47022009A US8827961B2 US 8827961 B2 US8827961 B2 US 8827961B2 US 47022009 A US47022009 A US 47022009A US 8827961 B2 US8827961 B2 US 8827961B2
US12/470,220
US20090227956A1 (en
Anthony L. Eaton
SALVUS TECHNOLOGY LIIMITED
2007-08-03 Priority to US81547507A priority
2009-05-21 Application filed by West Pharmaceutical Services Inc filed Critical West Pharmaceutical Services Inc
2009-05-21 Priority to US12/470,220 priority patent/US8827961B2/en
2009-05-22 Assigned to WEST PHARMACEUTICAL SERVICES, INC. reassignment WEST PHARMACEUTICAL SERVICES, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: NORTON, PAUL, EATON, ANTHONY L.
2009-05-22 Assigned to SALVUS TECHNOLOGY LIIMITED reassignment SALVUS TECHNOLOGY LIIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LICENCE, ANTHONY, EMMOTT, DOUGLAS ARTHUR, WESTON, TERENCE EDWARD
2009-09-10 Publication of US20090227956A1 publication Critical patent/US20090227956A1/en
2009-11-06 Priority claimed from EP20090175295 external-priority patent/EP2189173B1/en
2014-09-09 Publication of US8827961B2 publication Critical patent/US8827961B2/en
A safety needle for automatically covering a tip of a needle following removal of the needle from a patient is provided. The safety needle includes an injection device and a packing sleeve. The injection device has an initial position and an intermediate position. The packing sleeve has a generally hollow body surrounding at least a portion of the injection device in the initial position and the intermediate position. The hollow body includes at least one track having an activation leg and a releasing leg. The at least one track is configured to slidingly engage with at least one member of the injection device to move the injection device to the intermediate position. The packing sleeve is removable from the injection device only when the injection device is in the intermediate position.
FIG. 9 shows the device as assembled by the manufacturer, and comprises a needle hub 7, being of conical or other tapering form. The slidable sleeve 5 has cantilever arms 9 attached or integral, the arms 9 terminating with an radially inwardly extending projection 33, which engages with undercut 34 of the needle hub 7, shown in greater detail in FIG. 9 a. In the position shown, there is little load on the spring cantilever arms 9, but sufficient to hold the components together. Referring to FIG. 10, this is a center-line cross-section through the safety needle assembled into its pack 35. The pack 35 is releasably mounted on the needle hub 7 and slidable sleeve 5, that is the safety needle 1 is held within the pack 35, for example by friction, but may be removed by the user. To facilitate the releasable mounting the pack 35 and safety needle 1 have engageable portions which may simply be the surfaces of the pack 35 and safety needle 1. These surfaces may be textured or have projections. The pack 35 is preferably tubular and also preferably made from a deep-drawn vacuum formed plastic material. The pack 35 is shown with a flange 36 and open at the receiving end of the needle hub 7, and closed at the injection end by the extension 37. The inner face of shoulder 38 rests on the end face of the slidable sleeve 5. The needle hub 7 has one or more projections 39, which provide a light frictional retaining force on the inside of the pack 35 to prevent the safety needle 1 from falling out. The safety needle 1 may be further retained inside the pack 35 by a releasable (peel-off) membrane 40, which is preferably gas permeable. The membrane 40 is bonded to flange 36, and may be made from a porous material such as TYVEK® brand spunbonded olefin i.e., a spun-bonded high-density polyethylene available from DuPont and which is used extensively in pharmaceutical packaging to permit a sterilizing gas, such as ethylene oxide, to penetrate the pack 35 while preventing ingress of bacteria during storage. Other peelable materials may be used according to the sterilization process used. The membrane 40 may have a tag 41 to assist removal. The needle hub 7 has a syringe adaptor 24 which may be configured to suit the common Luer taper or threaded Luer lock syringe nozzles.
The packing sleeve 235 includes a generally hollow body 270 has a distal end 270 a and an open proximal end 270 b. The body 270 surrounds at least a portion of the safety needle 101, preferably the entire safety needle 101, and the open proximal end 270 b is initially preferably covered by a releasable membrane 240 such that the safety needle 101 is sealed within the packing sleeve 235. The membrane 240 is bonded to a flange 272 extending radially outwardly from the body 270 proximate the proximal end 270 b. The membrane 240 is preferably gas permeable and may be made from a porous material such as TYVEK® brand spunbonded olefin i.e., a spun-bonded high-density polyethylene available from DuPont and which is used extensively in pharmaceutical packaging to permit a sterilizing gas, such as ethylene oxide, to penetrate the pack 235 while preventing ingress of bacteria during storage. Other peelable materials may be used according to the sterilization process used. The membrane 240 may have a tab or tag (not shown) to assist removal. The body 270 is preferably tubular and is made from a deep-drawn vacuum formed polymeric material but the body 270 may have any shape such as rectangular and may be comprised of any suitable material.
Referring to FIGS. 25A-25J, the safety needle 301 is preferably initially sealed within the packing sleeve 235 described above (FIGS. 25A-25D). The packing sleeve 235 must be first moved further over the hub 307 before the packing sleeve 235 can be removed from the safety needle 301(FIGS. 25C-25D). Removing the packing sleeve 235 urges the slidable sleeve 305 over the hub 307 such that the feet 333 are urged along the ramped indents 355 and into the catches 356. The catches 356 retain the slidable sleeve 305 in an intermediate position (FIG. 25E). The tip 303 a of the needle 303 preferably extends slightly from the slidable sleeve 305 in the intermediate position though the tip 303 a may be partially shrouded or entirely covered. The slidable sleeve 305 is preferably spring biased against the hub 307 in the intermediate position. The tip 303 a of the needle 303 is then injected into the skin 48 (FIGS. 25F and 25G). The needle 303 may extend into the skin 48 and into the subcutaneous tissue 49 depending on the type of injection. The needle 303 may have a predetermined maximum exposed length to prevent over insertion into the skin 48. As the needle 303 extends into the skin 48 the skin 48 abuts against the injection end 305 a of the slidable sleeve 305 generating a displacement force in the axial direction. The displacement force urges the slidable sleeve 305 axially with respect to the hub 307 such that the feet 333 contact the cammed surfaces 357 and twist the slidable sleeve with respect to the hub 307. The decrease of the radial dimension of the hub 307 causes the feet 333 to twist further away from the catches 356 such that the feet 333 are preferably spaced between the catches 356 (see FIGS. 23, 25F and 25G). The radially outwardly extending guides 358 prevent the slidable sleeve 305 from twisting too far in either circumferential direction if an external force twists the slidable sleeve 305 relative to the hub 307. However, the cammed surfaces 357 and the guides 358 may be omitted such that the direction of the feet 333 is dictated only by the slope of the outer surface 318 of the hub 307. Alternatively, the guides 358 may be more narrowly positioned to form a helical track that the feet 333 more closely follow. As the feet 333 slide toward the retracted position, a restoring force is generated within the slidable sleeve due to the radial expansion of the cantilever arms 309. Once the feet 333 are circumferentially spaced from the catches 356 the restoring force urges the slidable sleeve to move toward the injection end 307 a of the needle hub 307 down the outer surface 318 of the hub 307 and into the extended position upon removal of the displacement force (i.e. withdraw of the needle 303 from the skin 48). The feet 333 then slide into and are retained within the respective recess 359 in the extended position to “lock” the slidable sleeve 305 over the tip 303 a of the needle 303 to prevent reuse and/or an accidental needle stick of the needle 303.
an injection device having an initial position and an intermediate position; and
a packing sleeve having a generally hollow body surrounding at least a portion of the injection device in the initial position and the intermediate position, the body including at least one track having an activation leg and a releasing leg, the activation leg configured to slidingly engage with at least one member of the injection device to move the injection device to the intermediate position and wherein the packing sleeve is only removable from the injection device when the injection device is in the intermediate position.
2. The safety needle of claim 1, wherein the injection device has a needle with a tip, the needle extends from a hub, and a slidable sleeve at least partially surrounds the needle and is mounted on the hub, and wherein the at least one member extends radially from the hub.
3. The safety needle of claim 2, wherein the slidable sleeve abuts a ledge that at least partially forms a cavity at the distal end of the body and the needle extends into the cavity as the hub is moved toward the distal end of the body.
4. The safety needle of claim 2, the tip of the needle is at least partially shrouded by the slidable sleeve in the intermediate position.
5. The safety needle of claim 1, wherein pushing a proximal end of the injection device axially toward a distal end of the body advances the at least one member to a second end of the activation leg to set the injection device in the intermediate position and then subsequently pulling the proximal end of the injection device axially away from the packing sleeve releases the at least one member of the injection device from the packing sleeve with the injection device in the intermediate position.
6. The safety needle of claim 5, wherein the injection device must be first twisted relative to the packing sleeve before pulling the injection device axially away from a distal end of the packing sleeve.
7. The safety needle of claim 1, wherein the injection device further comprises:
a hub mounted to the needle and having an outer surface, a receiving end distal to the tip of the needle and an injection end proximal to the tip of the needle, at least part of the outer surface of the hub tapering toward the injection end; and
a slidable sleeve having a mounting end distal to the tip of the needle and an injection end proximal to the tip of the needle, the tip of the needle being located inside the slidable sleeve in an extended position, the tip of the needle projecting from the slidable sleeve in a retracted position, the slidable sleeve being slidably mounted to the hub between the receiving and injection ends of the hub in the initial position, the initial position being between the retracted and extended positions, the outer surface of the hub deflecting the slidable sleeve outwardly in a radial direction as the slidable sleeve slides axially toward the receiving end of the hub,
wherein a displacement force urges the slidable sleeve from the initial position toward the retracted position generating a restoring force within the slidable sleeve, the restoring force urging the slidable sleeve to move toward the injection end of the needle hub and into the extended position upon removal of the displacement force.
8. The safety needle of claim 7, wherein the packing sleeve includes at least one retaining rib aligned with and preventing radial deflection of a portion of the slidable sleeve in the initial position and unaligned with and allowing radial deflection of the portion of the slidable sleeve in a position other than the initial position.
9. The safety needle of claim 1, wherein the at least one member can only be moved in a circumferential direction relative to the body out from a first end of the activation leg.
10. The safety needle of claim 1, wherein the at least one member is a radially extending projection.
11. The safety needle of claim 1, wherein a portion of the activation leg allows the injection device to rotate relative to the body.
12. The safety needle of claim 1, wherein a portion of the activation leg allows the at least one member to be advanced toward a distal end of the body.
13. A safety needle for automatically covering a tip of a needle following removal of the needle from a patient, the safety needle comprising:
an injection device moveable between an initial position and an intermediate position, the injection device includes:
a needle extending from a hub and having a tip, and
a slidable sleeve at least partially surrounding the needle and mounted on the hub; and
a packing sleeve having a generally hollow body surrounding at least a portion of the injection device in the initial position and the intermediate position, the generally hollow body including at least one track having an activation leg and a releasing leg, the at least one track configured to slidingly engage with at least one member of the injection device to move the injection device to the intermediate position and wherein the packing sleeve is only removable from the injection device when the injection device is in the intermediate position.
US12/470,220 2005-02-03 2009-05-21 Safety needle Active 2025-10-03 US8827961B2 (en)
US81547507A true 2007-08-03 2007-08-03
US12/470,220 US8827961B2 (en) 2005-02-03 2009-05-21 Safety needle
US81547507A Continuation-In-Part 2007-08-03 2007-08-03
US20090227956A1 US20090227956A1 (en) 2009-09-10
US8827961B2 true US8827961B2 (en) 2014-09-09
ID=41054407
US12/470,220 Active 2025-10-03 US8827961B2 (en) 2005-02-03 2009-05-21 Safety needle
US (1) US8827961B2 (en)
GB201020542D0 (en) * 2010-12-03 2011-01-19 Liversidge Barry P Medical needle safety device
GB201100488D0 (en) * 2011-01-12 2011-02-23 Liversidge Barry P Medical needle safety devices
GB2490807A (en) 2011-05-11 2012-11-14 New Injection Systems Ltd Injector with rigid outer container
GB201222900D0 (en) * 2012-12-19 2013-01-30 Tip Top Com Ltd Medical needle safety device
2009-05-21 US US12/470,220 patent/US8827961B2/en active Active
Chinese Office Action for the related Chinese Patent Application No. 200680006138.6 dated Dec. 11, 2009; English translation only.
European Search Report for the related European Patent Application No. 03 25 2192, dated May 26, 2003.
European Search Report for the related European Patent Application No. 03 25 7489; dated May 25, 2004.
Examination Report in the related Australian Patent Application No. 2004212245, dated Nov. 11, 2008.
First Chinese Office Action for the related Chinese Patent Application No. 200480006925.1; dated Dec. 28, 2007; English translation only.
International Search Report and Written Opinion for the related International Patent Application No. PCT/GB2005/000357, issued Aug. 26, 2005.
International Search Report for the related International Patent Application No. PCT/GB2004/000516; mailed May 27, 2004.
Office Action for the related U.S. Appl. No. 11/817,075 issued Dec. 21, 2009.
Office Action Issued Apr. 29, 2011 in U.S. Appl. No. 12/276,679.
Office Action issued Dec. 23, 2011 in U.S. Appl. No. 12/276,679.
Office Action issued Dec. 5, 2012 in U.S. Appl. No. 12/276,679.
Office Action issued Jan. 22, 2014 in U.S. Appl. No. 11/817,075 by Weston.
Office Action issued May 2, 2014 in IN Application No. 6141/DELNP/2007.
Office Action issued May 9, 2014 in BR Application No. PI0407376-2.
Partial European Search Report for the related European Application No. 09175295.6 dated Apr. 9, 2010.
Search Report for the related U.K. Patent Application No. 0621157.7; dated Jan. 25, 2007.
Second Chinese Office Action for the related Chinese Patent Application No. 200480006925.1; dated Feb. 20, 2009; English translation only.
Written Opinion for the related International Patent Application No. PCT/GB2004/000516 issued May 27, 2004.
US20090227956A1 (en) 2009-09-10
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:NORTON, PAUL;EATON, ANTHONY L.;REEL/FRAME:022726/0564;SIGNING DATES FROM 20080929 TO 20081031
Owner name: SALVUS TECHNOLOGY LIIMITED, UNITED KINGDOM
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:EMMOTT, DOUGLAS ARTHUR;LICENCE, ANTHONY;WESTON, TERENCE EDWARD;REEL/FRAME:022728/0523;SIGNING DATES FROM 20081002 TO 20081008
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:NORTON, PAUL;EATON, ANTHONY L.;SIGNING DATES FROM 20080929 TO 20081031;REEL/FRAME:022726/0564
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:EMMOTT, DOUGLAS ARTHUR;LICENCE, ANTHONY;WESTON, TERENCE EDWARD;SIGNING DATES FROM 20081002 TO 20081008;REEL/FRAME:022728/0523