The present invention relates generally to injection devices for administering therapeutic agents to patients, particularly to safety devices for syringes, and more particularly to syringe devices that include a needle guard slidably coupled to a syringe for covering a needle of the syringe after use.
Medication is often dispensed using a medicine cartridge, such as a syringe, having a barrel with a needle extending from one end and a plunger slidably inserted into the other end. Such cartridges are often referred to as “pre-filled syringes” because they may contain a specific dosage or volume of medication when they are initially provided, as compared to conventional syringes that are furnished empty and filled by the user before making an injection.
Alternatively, a medicine cartridge may be used, such as an ampoule or vial, that includes a penetrable seal instead of a needle on one end of the barrel, and/or a piston rather than a plunger on the other end. Such medicine cartridges are generally inserted into an adapter that includes a hollow body adapted to hold the cartridge, a plunger to engage and move the piston in the cartridge, and a double-ended needle to penetrate the seal and communicate with the interior of the barrel.
Because of the risk of communicable diseases, a number of syringes and adapters have been developed that are intended to prevent accidental needle sticks and/or inadvertent reuse of a syringe. Retractable needle devices have been suggested for this purpose that include a cartridge that allows a needle of the cartridge to be withdrawn into the barrel after medication is dispensed from it. For example, U.S. Pat. No. 4,973,316 discloses a syringe including a barrel having a needle assembly that is slidable within the barrel between an exposed position such that a needle on the assembly extends from the barrel and a retracted position wherein the needle assembly is withdrawn into the barrel. The needle assembly is initially locked in the exposed position, but may be disengaged upon depression of the plunger, whereupon a spring biases the assembly towards the retracted position, thereby withdrawing the needle into the barrel.
Alternatively, syringe holders have been suggested that include a body within which a conventional syringe or cartridge may be received, and a shield that is manually slidable with respect to the body to cover the needle. For example, U.S. Pat. No. 6,030,366 which is assigned to the assignee of the present application, discloses a self-shielding guard that includes a body having an open proximal end for inserting a syringe into a cavity within the body, and a distal end with an opening through which a needle on the syringe may extend once received in the body. A shield is slidable over the body between retracted and extended positions to expose and cover the needle, respectively. With the shield in the retracted position and the needle exposed, an injection may be made, and then the shield may be manually advanced to the extended position. In the extended position, cooperating detents and detent pockets on the body and shield substantially permanently lock together, thereby preventing reuse of the needle, reducing the risk of accidental needle sticks, and/or facilitating disposal of the syringe.
As an alternative to requiring manual extension of a shield to cover a needle, spring-loaded devices have also been developed. These devices often include a body and slidable shield, similar to the manual devices described above, but also may include a spring element to bias the shield to advance and cover the needle. An actuator, such as a button or lever, may be activated by the user to release the shield, thereby allowing the spring element to advance the shield to cover the needle. For example, U.S. Pat. No. 5,695,475 and U.S. Pat. No. 4,923,447 disclose spring-loaded syringe devices that include inner and outer sliding sleeves that include a button slidable in a longitudinal slot to selectively expose and cover a needle on the devices. A spring in the devices biases one of the sleeves to extend and cover the needle, but this bias may be manually overcome to expose the needle. Thus, these devices may not lock the extending sleeve in a covered position, and therefore may risk accidental needle exposure and/or reuse of the needle. In addition, although these devices are spring-driven, their shields may not extend unless they are manually activated by using a button, and therefore are not truly “passive,” but require an affirmative decision by a user to activate their safety feature.
Improved automatic syringe and guard assemblies have been developed comprising a body for receiving a syringe, and a guard or shield slideably disposed on the body, and further including detents for maintaining the shield in a first position in which a needle of the syringe is exposed for use, and in a second position covering the needle after use. A suitable spring is disposed between the body and guard to bias the guard and body to the second position. Several examples are U.S. Pat. Nos. 6,623,459 and 6,613,022.
The present invention is directed to injection devices incorporating both a syringe, such as a pre-filled syringe, or a medicine cartridge, and a guard that covers a needle of the syringe after a medication in the syringe is injected into a patient. More particularly, the present invention is directed to a syringe design which requires no separate body, and a guard disposed on the syringe, and wherein the syringe and guard are each formed of one piece from plastic. The guard includes one or more latch members forming a detent or detents for retaining the guard in a position on the syringe for exposing a needle of the syringe, and wherein the detent or detents may be released upon predetermined depression of a plunger of the syringe to cause the needle of the syringe to be covered by the guard.
In accordance with one aspect of the present invention, an injection device is provided that includes a syringe having a proximal end, a distal end, and a plunger extending from the proximal end. The injection device also includes a guard having a proximal end, a distal end, and a cavity therebetween. The guard is slidably mounted onto the syringe, and includes a latch member that extends proximally from the guard. A needle may extend from the distal end of the syringe. The guard is biased from a first or retracted position wherein the needle of the syringe is exposed, toward a second or extended position wherein the guard covers the needle. The guard may be biased by a spring element between the syringe and guard, such as located in the distal portion of the guard between the guard and the syringe.
First cooperating detents on the syringe and the guard act to retain the guard in the first position. The first cooperating detents preferably include a ledge on the proximal end of the syringe and a catch on a latch member extending from the guard. Here, the ledge and catch engage one another to retain the guard in the first position. As the plunger is advanced within the syringe, the plunger engages the latch member and releases the first cooperating detents, whereupon the guard slides toward the second position. Second cooperating detents are provided on the syringe and guard to retain the guard in the second position. The second cooperating detents preferably include a detent pocket on the guard and a corresponding tab on the syringe.
More particularly, the syringe comprises a central body having a cylindrical opening for containing medicine and a plunger, and one or more elongated rectangular members or rails disposed on opposite sides of the body and which rails are configured to fit and slide within the guard. The proximal end of the syringe can include suitable gripping surfaces, and the distal end includes a hub to which a needle may be attached such as by threads or a luer lock.
Optionally, the guard may also include a window or slot that extends axially along the guard. When the slot is present on the guard, the syringe may include a stop tab configured to travel within the slot. The stop tab and slot may be configured to limit the proximal and distal movement of the syringe relative to the guard. For example, the stop tab may abut the distal edge of the window when the guard is in the first position to prevent further distal movement of the syringe (or proximal movement of the guard). Similarly, the stop tab may abut the proximal edge of the window when the guard is in the second position to prevent further proximal movement of the syringe (or distal movement of the guard). In addition, the guard may also include a set of finger flanges or grips usable for controlling the movement and speed of advancement or sliding of the guard between the first and second positions with respect to the syringe.
Other advantages and features of the present invention will become apparent from consideration of the following description taken in conjunction with the accompanying drawings.
a is a prospective view of the syringe.
b is a top plan view of the syringe.
c is a side elevational view.
d is a cross-sectional view taken along line 3d-3d of
e is a proximal end view of the syringe.
a is a top plan view of the guard.
b is a side elevational view.
c is a cross-sectional view taken along a line 4c-4c of
d is an enlarged proximal end elevational view.
Turning now to the drawings, and first to
The guard 14 is configured to slide between the retracted position shown in
Reference is now made to the drawings of the syringe and guard in
Turning more specifically to the syringe
After an injection is made, the guard and syringe move, preferably via spring action from a spring (not shown) between the distal ends of the syringe and guard, to the relative positions shown in
While the invention is susceptible to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular forms or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents and alternatives falling within the spirit and scope of the appended claims.
Number | Name | Date | Kind |
---|---|---|---|
827383 | McElroy et al. | Jul 1906 | A |
1652894 | Gunther | Dec 1927 | A |
1921034 | Lamarche | Aug 1933 | A |
2432605 | Barach | Dec 1947 | A |
2571653 | Bastien | Oct 1951 | A |
2586581 | Tschischeck | Feb 1952 | A |
2895474 | Reznek | Jul 1959 | A |
2925083 | Craig | Feb 1960 | A |
3046985 | Saenz | Jul 1962 | A |
3306290 | Weltman | Feb 1967 | A |
3583230 | Patterson | Jun 1971 | A |
3583399 | Ritsky | Jun 1971 | A |
3878846 | Rimbaud | Apr 1975 | A |
3885562 | Lampkin | May 1975 | A |
3930499 | Rimbaud | Jan 1976 | A |
3943927 | Norgren | Mar 1976 | A |
3973554 | Tipton | Aug 1976 | A |
4018223 | Ethington | Apr 1977 | A |
4022207 | Citrin | May 1977 | A |
4048997 | Raghavachari et al. | Sep 1977 | A |
4171699 | Jones et al. | Oct 1979 | A |
4333456 | Webb | Jun 1982 | A |
4333457 | Margulies | Jun 1982 | A |
4356822 | Winstead-Hall | Nov 1982 | A |
4381779 | Margulies | May 1983 | A |
4425120 | Sampson et al. | Jan 1984 | A |
4425230 | Andress et al. | Jan 1984 | A |
4540405 | Miller et al. | Sep 1985 | A |
4573976 | Sampson et al. | Mar 1986 | A |
4592744 | Jagger et al. | Jun 1986 | A |
4601711 | Ashbury et al. | Jul 1986 | A |
4631057 | Mitchell | Dec 1986 | A |
4643199 | Jennings, Jr. et al. | Feb 1987 | A |
4655751 | Harbaugh | Apr 1987 | A |
4681567 | Masters et al. | Jul 1987 | A |
4690676 | Moulding, Jr. et al. | Sep 1987 | A |
4702738 | Spencer | Oct 1987 | A |
4723943 | Spencer | Feb 1988 | A |
4728321 | Chen | Mar 1988 | A |
4737144 | Choksi | Apr 1988 | A |
4738663 | Bogan | Apr 1988 | A |
4743234 | Leopoldi et al. | May 1988 | A |
4747831 | Kulli | May 1988 | A |
4762516 | Luther et al. | Aug 1988 | A |
4767413 | Haber et al. | Aug 1988 | A |
4772272 | McFarland | Sep 1988 | A |
4795443 | Permenter et al. | Jan 1989 | A |
4801295 | Spencer | Jan 1989 | A |
4813426 | Haber et al. | Mar 1989 | A |
4820275 | Haber et al. | Apr 1989 | A |
4832696 | Luther et al. | May 1989 | A |
4840185 | Hernandez | Jun 1989 | A |
4850961 | Wanderer et al. | Jul 1989 | A |
4850994 | Zerbst et al. | Jul 1989 | A |
4869249 | Crossman et al. | Sep 1989 | A |
4871355 | Kikkawa | Oct 1989 | A |
4874384 | Nunez | Oct 1989 | A |
4878902 | Wanderer et al. | Nov 1989 | A |
4892523 | Haber et al. | Jan 1990 | A |
4898590 | Andors | Feb 1990 | A |
4900310 | Ogle, II | Feb 1990 | A |
4911693 | Paris | Mar 1990 | A |
4915701 | Halkyard | Apr 1990 | A |
4915702 | Haber | Apr 1990 | A |
4917669 | Bonaldo | Apr 1990 | A |
4917673 | Coplin | Apr 1990 | A |
4923445 | Ryan | May 1990 | A |
4923447 | Morgan | May 1990 | A |
4927416 | Tomkiel | May 1990 | A |
4932947 | Cardwell | Jun 1990 | A |
4935016 | Delco | Jun 1990 | A |
4938745 | Sagstetter | Jul 1990 | A |
4946446 | Vadher | Aug 1990 | A |
4946447 | Hardcastle et al. | Aug 1990 | A |
4955868 | Klein | Sep 1990 | A |
4957490 | Byrne et al. | Sep 1990 | A |
4969877 | Kornberg | Nov 1990 | A |
4974603 | Jacobs | Dec 1990 | A |
4990141 | Byrne et al. | Feb 1991 | A |
5000744 | Hoffman et al. | Mar 1991 | A |
5002537 | Hoffman et al. | Mar 1991 | A |
5007903 | Ellard | Apr 1991 | A |
5013301 | Marotta, Jr. et al. | May 1991 | A |
5013305 | Opie et al. | May 1991 | A |
5030209 | Wanderer et al. | Jul 1991 | A |
5033650 | Colin et al. | Jul 1991 | A |
5045066 | Scheuble et al. | Sep 1991 | A |
5057087 | Harmon | Oct 1991 | A |
5059184 | Dyke | Oct 1991 | A |
5059185 | Ryan | Oct 1991 | A |
5067490 | Haber | Nov 1991 | A |
5067945 | Ryan et al. | Nov 1991 | A |
5069225 | Okamura | Dec 1991 | A |
5070884 | Columbus et al. | Dec 1991 | A |
5070885 | Bonaldo | Dec 1991 | A |
5085639 | Ryan | Feb 1992 | A |
5086780 | Schmitt | Feb 1992 | A |
5086982 | Ryan | Feb 1992 | A |
5088982 | Ryan | Feb 1992 | A |
5088986 | Nusbaum | Feb 1992 | A |
5088988 | Talonn et al. | Feb 1992 | A |
5098382 | Haber et al. | Mar 1992 | A |
5100427 | Crossman et al. | Mar 1992 | A |
5100428 | Mumford | Mar 1992 | A |
5104380 | Holman et al. | Apr 1992 | A |
5104386 | Alzain | Apr 1992 | A |
5106379 | Leap | Apr 1992 | A |
5108376 | Bonaldo | Apr 1992 | A |
5108378 | Firth et al. | Apr 1992 | A |
5112307 | Haber et al. | May 1992 | A |
5116319 | Van Den Haak | May 1992 | A |
5120311 | Sagstetter et al. | Jun 1992 | A |
5131405 | Burns | Jul 1992 | A |
5137521 | Wilkins | Aug 1992 | A |
5141500 | Hake | Aug 1992 | A |
5147326 | Talonn et al. | Sep 1992 | A |
5154699 | Ryan | Oct 1992 | A |
5163917 | Huefner et al. | Nov 1992 | A |
5176656 | Bayless | Jan 1993 | A |
5176657 | Shields | Jan 1993 | A |
5201708 | Martin | Apr 1993 | A |
5201720 | Borgia et al. | Apr 1993 | A |
5207646 | Brunel | May 1993 | A |
5215535 | Gettig et al. | Jun 1993 | A |
5219339 | Saito | Jun 1993 | A |
5242416 | Hutson | Sep 1993 | A |
5242420 | Martin | Sep 1993 | A |
5246011 | Caillouette | Sep 1993 | A |
5259841 | Hohendorfer et al. | Nov 1993 | A |
5266072 | Utterberg et al. | Nov 1993 | A |
5269766 | Haber et al. | Dec 1993 | A |
5273541 | Malenchek | Dec 1993 | A |
5279581 | Firth et al. | Jan 1994 | A |
5300030 | Crossman et al. | Apr 1994 | A |
5328485 | Moreno et al. | Jul 1994 | A |
5330438 | Gollobin et al. | Jul 1994 | A |
5336185 | Lynch et al. | Aug 1994 | A |
5342320 | Cameron | Aug 1994 | A |
5344407 | Ryan | Sep 1994 | A |
5372590 | Haber | Dec 1994 | A |
5385557 | Thompson | Jan 1995 | A |
5407431 | Botich et al. | Apr 1995 | A |
5417660 | Martin | May 1995 | A |
5433712 | Stiles et al. | Jul 1995 | A |
5437639 | Malenchek | Aug 1995 | A |
5437647 | Firth et al. | Aug 1995 | A |
5445620 | Haber et al. | Aug 1995 | A |
5492536 | Mascia | Feb 1996 | A |
5496286 | Stiehl et al. | Mar 1996 | A |
5498244 | Eck | Mar 1996 | A |
5501672 | Firth et al. | Mar 1996 | A |
5514107 | Haber et al. | May 1996 | A |
5522812 | Talonn | Jun 1996 | A |
5531706 | De la Fuente | Jul 1996 | A |
5554122 | Emanuel | Sep 1996 | A |
5562624 | Righi et al. | Oct 1996 | A |
5562626 | Sanpietro | Oct 1996 | A |
5569211 | Lekhgolts et al. | Oct 1996 | A |
5571089 | Crocker | Nov 1996 | A |
5573508 | Thornton | Nov 1996 | A |
5573512 | van den Haak | Nov 1996 | A |
5573513 | Wozencroft | Nov 1996 | A |
5575771 | Walinsky | Nov 1996 | A |
5599309 | Marshall et al. | Feb 1997 | A |
5611783 | Mikkelsen | Mar 1997 | A |
5611809 | Marshall et al. | Mar 1997 | A |
5616134 | Firth et al. | Apr 1997 | A |
5624400 | Firth et al. | Apr 1997 | A |
5643214 | Marshall et al. | Jul 1997 | A |
5674203 | Lewandowski | Oct 1997 | A |
5695475 | Best, Jr. et al. | Dec 1997 | A |
5709663 | Younkes | Jan 1998 | A |
5716340 | Schweich, Jr. et al. | Feb 1998 | A |
5762635 | Pace et al. | Jun 1998 | A |
5855839 | Brunel | Jan 1999 | A |
5928205 | Marshall | Jul 1999 | A |
5980487 | Jones et al. | Nov 1999 | A |
5989226 | Hymanson | Nov 1999 | A |
6004296 | Jansen et al. | Dec 1999 | A |
6015402 | Sahota | Jan 2000 | A |
6017330 | Hitchins et al. | Jan 2000 | A |
6030366 | Mitchell | Feb 2000 | A |
6077247 | Marshall et al. | Jun 2000 | A |
6086568 | Caizza | Jul 2000 | A |
6102893 | Aneas | Aug 2000 | A |
6159181 | Crossman et al. | Dec 2000 | A |
6159184 | Perez et al. | Dec 2000 | A |
6171283 | Perez et al. | Jan 2001 | B1 |
6186980 | Brunel | Feb 2001 | B1 |
6193695 | Rippstein, Jr. | Feb 2001 | B1 |
6203530 | Stewart | Mar 2001 | B1 |
6206853 | Bonnet | Mar 2001 | B1 |
RE37439 | Firth et al. | Nov 2001 | E |
6319233 | Jansen et al. | Nov 2001 | B1 |
6319234 | Restelli et al. | Nov 2001 | B1 |
6344032 | Perez et al. | Feb 2002 | B1 |
6416323 | Grenfell et al. | Jul 2002 | B1 |
6425880 | Marshall | Jul 2002 | B1 |
6461333 | Frezza | Oct 2002 | B1 |
4923477 | Hansen | Feb 2003 | A1 |
6550967 | Hedaya | Apr 2003 | B2 |
6613022 | Doyle | Sep 2003 | B1 |
6623459 | Doyle | Sep 2003 | B1 |
6719730 | Jansen et al. | Apr 2004 | B2 |
6719736 | Collins et al. | Apr 2004 | B2 |
6752798 | McWethy et al. | Jun 2004 | B2 |
6846302 | Shemesh et al. | Jan 2005 | B2 |
6976976 | Doyle | Dec 2005 | B2 |
20010005781 | Amark | Jun 2001 | A1 |
20020032412 | Riemelmoser | Mar 2002 | A1 |
20020045864 | Perez et al. | Apr 2002 | A1 |
20020169421 | McWethy et al. | Nov 2002 | A1 |
20020193746 | Chevallier | Dec 2002 | A1 |
20030069545 | Doyle | Oct 2003 | A1 |
20030187402 | Doyle | Oct 2003 | A1 |
Number | Date | Country |
---|---|---|
0 405 039 | Jan 1991 | EP |
0467173 | Jan 1992 | EP |
0 555974 | Aug 1993 | EP |
0 680 767 | Nov 1995 | EP |
0 740 942 | Nov 1996 | EP |
0 864 335 | Sep 1998 | EP |
0 940 153 | Sep 1999 | EP |
0 966 983 | Dec 1999 | EP |
1371382 | Dec 2003 | EP |
1284769 | Nov 2005 | EP |
2 654 346 | May 1991 | FR |
2 782 011 | Aug 1998 | FR |
2 764 195 | Dec 1998 | FR |
2 788 984 | Jan 1999 | FR |
2 788 985 | Jul 1999 | FR |
2 778 853 | Nov 1999 | FR |
2 799 976 | Apr 2001 | FR |
2 801 795 | Jun 2001 | FR |
2 283 425 | May 1995 | GB |
WO 8802297 | Apr 1988 | WO |
WO 9118634 | Dec 1991 | WO |
WO 9300949 | Jan 1993 | WO |
WO 9317732 | Sep 1993 | WO |
WO 9504565 | Feb 1995 | WO |
WO 9835714 | Aug 1998 | WO |
WO 9916489 | Apr 1999 | WO |
WO 9917823 | Apr 1999 | WO |
WO 9932177 | Jul 1999 | WO |
WO 9937343 | Jul 1999 | WO |
WO 9937345 | Jul 1999 | WO |
WO 9956805 | Nov 1999 | WO |
WO 0076565 | Jan 2000 | WO |
WO 0033900 | Jun 2001 | WO |
WO 0141841 | Jun 2001 | WO |
WO 0180931 | Nov 2001 | WO |
WO 0185239 | Nov 2001 | WO |
WO 0185239 | Nov 2001 | WO |
WO 03013632 | Feb 2003 | WO |
WO 03082385 | Oct 2003 | WO |
WO 03082386 | Oct 2003 | WO |
WO 2006050304 | Nov 2006 | WO |
Entry |
---|
U.S. Patent and Trademark Office, Official Gazette, vol. 1223, No. 2, pp. 818, 819, and 820, dated Jun. 8, 1999. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1223, No. 4, pp. 2156, 2157, and 2575, dated Jun. 22, 1999. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1224, No. 1, pp. 303, 305, and 306 dated Jul. 6, 1999. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1224, No. 4, p. 3115 and 3404, dated Jul. 27, 1999. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1232, No. 1, pp. 381, 382, 384, 385, 386, and 387, dated Mar. 7, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1232, No. 2, pp. 1507, 1508, and 1509, dated Mar. 14, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1232, No. 3, p. 2532, dated Mar. 21, 2000 Book 2 of 2 Books. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1232, No. 4, p. 3505, dated Mar. 28, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1234, No. 4, pp. 3543 and 3829, May 23, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1235, No. 2, pp. 1234, 1443, and 1444, dated Jun. 13, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1235, No. 3, pp. 2456 and 2457, dated Jun. 20, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1236, No. 1, p. 443, dated Jul. 4, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1236, No. 2, pp. 1625 and 1626, dated Jul. 11, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1236, No. 3, pp. 2873 and 2874, dated Jul. 18, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1236, No. 4, pp. 3963 and 3964, dated Jul. 25, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1237, No. 1, pp. 435 and 436, dated Aug. 1, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1237, No. 2, pp. 1669 and 1670, dated Aug. 8, 2000. |
U.S. Patent and Trademark Office, Official Gazette, vol. 1237, No. 3, pp. 2845 and 2846, dated Aug. 15, 2000. |
Number | Date | Country | |
---|---|---|---|
20060264825 A1 | Nov 2006 | US |