1. Field of the Invention
The present invention relates to a medical device for delivering a dose of medicament by injection. More particularly, the present invention is directed to a syringe assembly having a mechanism for retracting the needle into the syringe barrel after use to prevent accidental needle sticks.
2. Description of the Related Art
Syringes used for the delivery of medicaments to patients are well known. Oftentimes syringes are prefilled with a dosage of a medicament or other substance by a pharmaceutical manufacturer and then distributed to end users such as health care professionals or patients for administration of the prefilled medicament. Such syringes typically include a cylindrical hollow barrel which may be formed of a glass or plastic material and which includes the medicament. One end of the barrel is fitted with a fixed or removable hollow needle, and the other end of the barrel receives a plunger having a stopper which is slidable with respect to the barrel for delivery of the medicament to the hollow needle, i.e., to urge the medicament toward and out of the needle. A syringe assembly, which typically includes the above-described components, is usually stored with a removable needle cover which protects the needle from damage during storage and handling. Prior to use, the needle cover is removed to expose the needle.
To prevent a syringe user and, in particular, a health care professional from inadvertent sticks by the needle after use of the syringe on a patient, the syringe assembly may incorporate a safety shield which forms a guard to cover the needle after use. Certain attributes to be considered in such syringe assemblies are that the shield should be intuitive and easy to use, should preferably provide consistent and reliable activation, and should be operable with one hand. Other attributes are that such syringe assemblies require no change in current medicament delivery techniques, allow for dose adjustment, are preferably autoclavable, and allow for the inspection of contents before and after activation of the shield. Moreover, the use of the shield must not detrimentally affect processing and filling of the syringe at the pharmaceutical company, the assembly (i.e., syringe assembly and safety shield) must be easy to manufacture, must prevent accidental activation, and must limit the possibility of incurring cosmetic or structural damages.
The present invention relates to a medical device including a syringe barrel assembly with a retractable needle cannula supported by a needle cannula hub. The needle cannula and needle cannula hub are retracted upon full delivery of the medicament dosage in the syringe.
The medical device includes a barrel having a forward end and a rear end and which defines a reservoir within which the medicament may be contained. A needle cannula having a forward tip and a rear end is mounted, at its rear end, to a needle cannula hub for providing fluid communication of the needle cannula with the reservoir. The needle cannula hub is selectively movable between an initial position in which the forward tip of the needle cannula is exposed, and a retracted position in which the forward tip of the needle cannula is disposed in the medical device. A barrel hub member is coupled to the forward end of the barrel over the needle cannula hub and is dimensioned to provide retractable telescoping movement of the needle cannula hub with respect to the barrel hub member to allow the needle cannula hub to move to the retracted position. A retaining member is seated between the forward end of the barrel and the barrel hub member for releasably securing the needle cannula hub at the barrel forward end when the needle cannula hub is in the initial position. An urging member is provided in contact with the needle cannula hub and the barrel hub for exerting a force to bias the needle cannula hub from the initial position to the retracted position. A plunger rod having a hollow first end bounded by an edge and supporting a stopper is positioned in the reservoir. The plunger rod has a second end having a thumb pad for receiving medicament delivery pressure for causing the plunger to move within the reservoir to cause the medicament to be expelled from the reservoir. The plunger edge is configured for piercing the stopper when the stopper is fully inserted into the barrel and for interacting with the retaining member to release the needle cannula hub from the retaining member. This allows the needle cannula hub to move, by the urging member, to the retracted position through the hollow front end of the plunger rod.
In one embodiment, the retaining member is cylindrically-shaped and has a forward face and a rear end defining a bore. The forward face is dimensioned for seating at the forward end of the barrel.
In another embodiment, the retaining member comprises a flange proximate the forward face of the retaining member for seating between the barrel forward end and the barrel hub member. A seat is defined on an inner wall of the retaining member which bounds the bore for providing releasable securement of the needle cannula hub to the retaining member.
In another embodiment, the plunger rod forward end pierces the front face of the stopper and also acts directly on the retaining member to release the needle cannula hub from the retaining member to allow the needle cannula hub to move to the retracted position.
In another embodiment, the urging member is a coil spring which is arranged on the needle cannula hub and contacts the needle cannula hub and the barrel hub member for urging the needle cannula hub to the retracted position.
In another embodiment, the plunger rod is aligned with the bore formed in the retaining member for radially expanding the bore when the first end of the plunger is pressed into the bore, for releasing the needle cannula hub from the retaining member.
Other objects and features of the present invention will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed solely for purposes of illustration and not as a definition of the limits of the invention, for which reference should be made to the appended claims. It should be further understood that the drawings are not necessarily drawn to scale and that, unless otherwise indicated, they are merely intended to conceptually illustrate the structures and procedures described herein.
In the drawings, wherein like reference characters denote similar elements throughout the several views:
The medical device 10 includes a syringe barrel 24 having a front end 124 and a rear end 224. The barrel 24 is preferably made of molded plastic. Alternatively, the barrel 24 may be formed from glass. The barrel 24 defines a reservoir 25 within which the medicament may be held prior to the use of the medical device 10. A needle cannula 26 having a forward tip 126 and a rearward end 226 is mounted in a needle cannula hub 34 proximate the front end 124 of the barrel 24. The needle cannula 26 is permanently connected to the needle cannula hub using an adhesive, glue, friction fit or other known or hereafter developed material or technique. The rear end 226 of the needle cannula is in fluid communication with the reservoir 25 in the position shown in
A plunger or plunger rod 28 has a front end 51 which is disposed in the barrel 24. The plunger rod may be formed of plastic or other known moldable material and is configured as a hollow tube. Alternatively, the plunger rod 28 may include a hollow portion proximate the front end 51. A stopper or piston 30 having a front face 54 that is preferably made of a relatively thin rubber material is arranged on the front end 51 of the plunger rod 28 and is movable with the plunger rod 28 within the barrel 24. The front end 51 of the plunger rod is configured as, or surrounded by, a cutting edge 52 which may be integrally formed with the plunger rod 28 or separately formed and affixed to the front end of the plunger rod 28. The cutting edge 52 interacts with and pierces the front face 54 of the stopper 30 as the front face is pressed or clamped between the cutting edge 52 and the plug seal 50, which occurs at the completion of a medicament delivery stroke as explained below. A second end of the plunger rod 28 includes a thumb press area or thumb pad 32 used for receiving pressure from the user's thumb for moving the piston 30 into and within the barrel 24 for urging the medicament in the reservoir 25 into the needle cannula 26.
As further shown in
As shown most clearly in
The plug seal 50 is preferably formed from a moldable and elastic material, such as rubber, and is mounted in the hub adapter 22 and positioned at the barrel front end 124. As shown in
As shown in
As most clearly shown in
As an alternative to a friction fit between the hub adapter 22 and the front end 124 of the barrel 24, the barrel may be configured with threading 200 (as shown in
An urging member 42 is arranged between the needle cannula hub 34 and the hub adapter 22 for urging the needle cannula hub 34 in the direction of the rear end 224 of the barrel 24. In a preferred embodiment, a coil spring 42 is used and is dimensioned to facilitate insertion of the long cylindrical section 74 of the needle hub 34 such that one end of the spring contacts urging member seat 77 on the needle hub, and another end of the spring contacts flange 82 on the hub adapter 22. When in this position, the spring 42 is compressed or charged between the needle hub 34 and the hub adapter 22 to bias the needle hub 34 in a direction toward the rear end 224 of the barrel 24 during activation or release from the plug seal 50. As an alternative to a coil spring, a biasing arm or other force exerting member may be employed for this purpose.
With reference to
A description of an exemplary usage of a preferred embodiment of the medical device 10 will now be provided with reference to
The application of additional pressure to the plunger rod 28 causes the piston 30 to interact with the plug seal 50, which causes the piston to be clamped between the release surface 66 of the plug seal 50 and the front cutting end 52 of the plunger rod whereupon a portion of the front face 54 of the piston 30 is cut away from the piston 30. Continued pressure applied to the plunger rod causes the front end 51 to engage the release surface 66 and expand the central bore 59. Once this occurs, the needle hub 34 will be disengaged from the plug seal 50 to allow the needle hub, with the needle cannula 26 mounted thereto, to move to the retracted position contained in the plunger rod 28 by the urgency of the urging member 42. This movement will also push the detached portion of the front face 54 in a direction toward the thumb pad 32 as shown in
Thus, while there have shown and described and pointed out fundamental novel features of the invention as applied to a preferred embodiment thereof, it will be understood that various omissions and substitutions and changes in the form and details of the devices illustrated, and in their operation, may be made by those skilled in the art without departing from the spirit of the invention. For example, it is expressly intended that all combinations of those elements which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the invention. Moreover, it should be recognized that structures and/or elements shown and/or described in connection with any disclosed form or embodiment of the invention may be incorporated in any other disclosed or described or suggested form or embodiment as a general matter of design choice. It is the intention, therefore, to be limited only as indicated by the scope of the claims appended hereto.
Number | Name | Date | Kind |
---|---|---|---|
4573976 | Sampson | Mar 1986 | A |
4631057 | Mitchell | Dec 1986 | A |
4737144 | Choksi | Apr 1988 | A |
4747831 | Kulli | May 1988 | A |
4795432 | Karczmer | Jan 1989 | A |
4813940 | Parry | Mar 1989 | A |
4985021 | Straw | Jan 1991 | A |
4998920 | Johnson | Mar 1991 | A |
5026356 | Smith | Jun 1991 | A |
5053010 | McGary et al. | Oct 1991 | A |
5053018 | Talonn | Oct 1991 | A |
5061251 | Juhasz | Oct 1991 | A |
5151088 | Allison | Sep 1992 | A |
5156599 | Ranford | Oct 1992 | A |
5163918 | Righi | Nov 1992 | A |
5193552 | Columbus | Mar 1993 | A |
5197953 | Colonna | Mar 1993 | A |
5201708 | Martin | Apr 1993 | A |
5217437 | Talonn | Jun 1993 | A |
5242420 | Martin | Sep 1993 | A |
5246427 | Sturman | Sep 1993 | A |
5300040 | Martin | Apr 1994 | A |
5304149 | Morigi | Apr 1994 | A |
5308332 | Dillard, III | May 1994 | A |
5312372 | DeHarde et al. | May 1994 | A |
5336176 | Yoon | Aug 1994 | A |
5342309 | Hausser | Aug 1994 | A |
5342320 | Cameron | Aug 1994 | A |
5370628 | Allison | Dec 1994 | A |
5385551 | Shaw | Jan 1995 | A |
5385555 | Hausser | Jan 1995 | A |
5389085 | D'Alessio | Feb 1995 | A |
5417660 | Martin | May 1995 | A |
5562626 | Sanpietro | Oct 1996 | A |
5578011 | Shaw | Nov 1996 | A |
5651774 | Taranto | Jul 1997 | A |
5658254 | Reichenbach | Aug 1997 | A |
5681292 | Tober | Oct 1997 | A |
5713871 | Stock | Feb 1998 | A |
5735823 | Berger | Apr 1998 | A |
5769822 | McGary et al. | Jun 1998 | A |
5800395 | Botich | Sep 1998 | A |
5800403 | Pressly et al. | Sep 1998 | A |
5882342 | Cooper | Mar 1999 | A |
5935104 | Janek et al. | Aug 1999 | A |
5961491 | McGary et al. | Oct 1999 | A |
6017329 | Hake | Jan 2000 | A |
6077253 | Cosme | Jun 2000 | A |
6162197 | Mohammad | Dec 2000 | A |
6228054 | Dysarz | May 2001 | B1 |
6319233 | Jansen | Nov 2001 | B1 |
6409701 | Cohn et al. | Jun 2002 | B1 |
6432087 | Hoeck et al. | Aug 2002 | B1 |
6432088 | Huang et al. | Aug 2002 | B1 |
6440104 | Newby et al. | Aug 2002 | B1 |
6443929 | Kuracina | Sep 2002 | B1 |
6458101 | Hu | Oct 2002 | B1 |
6458105 | Rippstein et al. | Oct 2002 | B1 |
6461333 | Frezza | Oct 2002 | B1 |
6461362 | Halseth | Oct 2002 | B1 |
6475194 | Domici, Jr. | Nov 2002 | B2 |
6478780 | Shields | Nov 2002 | B1 |
6494863 | Shaw | Dec 2002 | B1 |
6511460 | Arnissolle | Jan 2003 | B1 |
6514229 | Huang | Feb 2003 | B1 |
6527742 | Malenchek | Mar 2003 | B1 |
6530903 | Wang | Mar 2003 | B2 |
6547762 | Botich | Apr 2003 | B1 |
6558357 | Hoeck | May 2003 | B1 |
6565540 | Perouse | May 2003 | B1 |
6569115 | Barker | May 2003 | B1 |
6569124 | Perouse | May 2003 | B1 |
6589209 | Dysarz | Jul 2003 | B1 |
6595954 | Luther | Jul 2003 | B1 |
6605073 | Pressly | Aug 2003 | B1 |
20020065488 | Suzuki et al. | May 2002 | A1 |
20020193737 | Popovsky | Dec 2002 | A1 |
20020193746 | Chevallier | Dec 2002 | A1 |
20020193747 | Denolly | Dec 2002 | A1 |
20030023205 | Botich | Jan 2003 | A1 |
20030028171 | DeHarde | Feb 2003 | A1 |
20030036730 | Von Teichert | Feb 2003 | A1 |
20030050601 | Righi | Mar 2003 | A1 |
20030050607 | Gaagnieux | Mar 2003 | A1 |
20030078546 | Jensen | Apr 2003 | A1 |
20030083627 | Chen | May 2003 | A1 |
20030114799 | Cheikh | Jun 2003 | A1 |
20030144630 | Chang | Jul 2003 | A1 |
20030149403 | Barker | Aug 2003 | A1 |
20030149404 | Lehmann | Aug 2003 | A1 |
Number | Date | Country |
---|---|---|
0 307 367 | Jun 1992 | EP |
0 680 767 | Nov 1995 | EP |
0 864 335 | Sep 1996 | EP |
0 740 942 | Nov 1996 | EP |
0 966 983 | Dec 1999 | EP |
1 258 263 | Nov 2002 | EP |
1 260 242 | Nov 2002 | EP |
0 901 391 | Jan 2003 | EP |
0 963 213 | Jan 2003 | EP |
1 273 316 | Jan 2003 | EP |
1 281 410 | Feb 2003 | EP |
0 916 354 | Mar 2003 | EP |
1 287 842 | Mar 2003 | EP |
1 291 029 | Mar 2003 | EP |
1 291 030 | Mar 2003 | EP |
1 317 938 | Jun 2003 | EP |
0 984 804 | Jul 2003 | EP |
1 329 234 | Jul 2003 | EP |
0 941 134 | Aug 2003 | EP |
1 205 173 | Sep 2003 | EP |
1 205 173 | Sep 2003 | EP |
0 734 738 | Oct 2003 | EP |
1 049 503 | Oct 2003 | EP |
2 830 764 | Apr 2003 | FR |
2 830 765 | Apr 2003 | FR |
2001193714 | Dec 2002 | JP |
WO 0141841 | Jun 2001 | WO |
WO 0141841 | Jun 2001 | WO |
WO 0160435 | Aug 2001 | WO |
WO 0185238 | Nov 2001 | WO |
WO 02089878 | Nov 2002 | WO |
WO 02098480 | Dec 2002 | WO |
WO 02098494 | Dec 2002 | WO |
WO 02098494 | Dec 2002 | WO |
WO 03000322 | Jan 2003 | WO |
WO 03000323 | Jan 2003 | WO |
WO 03011378 | Feb 2003 | WO |
WO 03015852 | Feb 2003 | WO |
WO 03022335 | Mar 2003 | WO |
WO 03033059 | Apr 2003 | WO |
WO 03033060 | Apr 2003 | WO |
WO 03041766 | May 2003 | WO |
WO 03045476 | Jun 2003 | WO |
WO 03045480 | Jun 2003 | WO |
WO 03045481 | Jun 2003 | WO |
WO 03063934 | Aug 2003 | WO |
WO 03068297 | Aug 2003 | WO |
WO 03068298 | Aug 2003 | WO |
Number | Date | Country | |
---|---|---|---|
20050159705 A1 | Jul 2005 | US |