The present disclosure relates to medical syringes and more particularly to a safety syringe with retractable needle.
According to present statistics, a high number of accidental injuries of medical personnel are caused by the sharp exposed tip of a syringe needle, after injection of the patient. Such needle may be highly contaminated and result in sickness or disease to the medial personnel beyond the physical discomfort of the needle penetration.
Syringes with retracting needles which allow for safe and easy disposal of the syringe while preventing reuse, are known. One example is described in U.S. Pat. No. 6,010,486 “Retracting Needle Syringe”. According to that device, a spring-preloaded needle carrier is triggered to retract into the piston at the end of the piston stroke. The device described in U.S. Pat. No. 6,010,486 is, however, somewhat complicated and difficult to manufacture and assemble. Accordingly, there is a need for a lower cost alternative to that design.
The present in invention provides numerous advantages relative to known syringes having retractable needles. The syringe can be manufactured with a reduced part count and simplified functionality of the components because of combined locking and sealing functions. The parts are of a design that can be easily mass produced and automatically assembled. Only minimal changes would be required to conventional tooling for the manufacturer of syringes. Moreover, no special user training is required.
In general, the present disclosure is directed to a retracting needle syringe of the type comprising a syringe barrel having a longitudinal axis and proximal and distal ends; a piston coaxially disposed in the barrel, having proximal and distal ends and a cavity with an opening toward the distal end. A needle assembly is situated within the distal end the barrel, having a hub, a hollow needle fixed in the hub with a tip extending forward of the barrel, and a spring seated between the distal end of the barrel and the hub, whereby a serum volume is defined between the hub and the distal end of the piston. A membrane is interposed between the hub and the opening at the distal end of the piston. A locking member is lodged between the barrel and the needle assembly, thereby holding the needle assembly within the distal end of the barrel to compress the spring while the needle projects from the barrel. With serum in the serum volume and the piston in a proximally retracted position, the piston is manually displaceable toward the needle assembly through functional positions in which the piston (a) forces the serum out of the serum volume through the needle, (b) urges the membrane against the hub, and (c) dislodges the locking member thereby releasing the needle assembly such that the spring displaces the hub and at least a portion of the membrane into the cavity and withdraws the needle tip into the distal end of the barrel.
In one embodiment, the hub has a piercing surface facing the opening at the distal end of the piston, and the membrane covers the opening. Preferably, the functional positions (a), (b), and (c) are sequential, such that between functional positions (b) and (c) of the piston, the piercing surface severs the membrane. Initially, the locking member is in a deformed state bearing on the periphery at the proximal end of the hub. A pusher on the piston is axially aligned with the locking member and displaceable along the periphery of the hub. This displacement drives the piercing surface through the membrane and thereafter dislodges the locking member thereby releasing the needle carrier into the cavity.
In another embodiment, the locking member is in a deformed state at the distal end of the barrel, bearing on the periphery of the distal end of the hub. The pusher is axially aligned with the hub, whereby displacement of the pusher surface to the actuation position urges the hub distally, such that the hub dislodges the locking member.
In the condition shown in
The protective cover 38 can be readily removed by pulling it axially, thereby disengaging the frictionally held base 40 of the cover, off the outside of nose 16, thereby exposing the needle 20 just prior to use on the subject.
As is more evident in
The needle carrier 18 has an elongated inner hub 52 which at its proximal end is integrated with a larger diameter outer hub 54, thereby defining an annular recess 56 therebetween. The spring 26 is compressed between a distal seat 58A formed by an internal shoulder on the nose 16, and proximal seat 58B at the end wall of recess 56, against the outer hub 54.
The proximal end of the needle carrier 18 defines a piercing surface 60 which, when the needle carrier is released as will be described below, is driven in the proximal direction by the expanding spring 26 to penetrate the frangible barrier 36 such that the needle assembly 18 enters the cavity 34. In the illustrated embodiment, the membrane 36 as installed is a generally cup-shaped piece of rubber or plastic, having a rim portion within an annular notch 62 near the distal end of the piston 14 where it is trapped by an annular seal ring 32, which slidingly bears on the inside diameter of the barrel 12. Preferably, the distal end of the piston is formed as a pusher, and particularly a pushing ring 64, which may have a tapered surface, but in any event is axially aligned with the lock member 28.
The cavity 34 can have a larger diameter opening 66 for facilitating the sliding of the cavity wall over the outside diameter or surface 68 of the outer hub 54, whereby the pusher 64 at the periphery of the barrier 36 can intersect with the locking member 28 as the piston 14 is pushed distally completely through chamber 30.
The lock member 28 is preferably an annular metal or similar washer-like ring or disk with an inner opening having a diameter slightly smaller than the outer diameter 68 of the outer hub 54, compressively deformed at a bend angle oblique to the axis of the syringe as shown at 70. The disk is rigidly supported on its distal side, preferably toward its periphery, at support surface 50, producing a radially inward holding force against the outer hub 54. This press fit at 68 holds the spring 26 in compression as shown in
Before injection, the piston 14 is withdrawn by overcoming the detents 76, 78, to a position represented by
Before the pusher ring 64 contacts the lock member 28 the piercing surface 60 on the outer hub has penetrated the barrier 38, such that the proximal end of the carrier 18 enters the cavity 34. The release of the lock member 28 decompresses the spring such that the spring displaces the needle carrier into the cavity and withdraws needle tip 22 into the distal end of the barrel, as shown in
It is preferable that the axial force of the piston 14 resulting from the user's pressure on the thumb pad break the barrier 36 and produce the initial entry of the needle carrier 18 into the cavity 34. Although the release of the lock member 28 could optionally drive the piercing surface 60 through the barrier and displace the needle carrier into the cavity simultaneously, performing these two functions in sequence minimizes the possibility of the carrier 18 hanging up during the piercing if this piercing function is dependent only on the force of the spring. Tighter tolerance would be needed for maintaining a precise coaxial relationship between the piercing face 60 and the opening of the cavity 34.
It should be appreciated that the locking disk as fabricated is initially completely flat, but because the disk ID is slightly smaller and the OD of the outer hub is slightly larger compared to the respective mating diameters of the needle carrier 18 and the cavity 34, the disk 28 as installed assumes a frusto conical shape. In this position the disk is very stable in supporting both mechanical (skin and tissue penetration by the needle tip) and hydraulic (vacuum during serum filling) coaxial forces. The spring 26 in the fully compressed state provides sufficient force to resist the hydraulic force generated by the relatively low injection pressure. However, when the piston approaches the end position, two events will take place. First, the piercing phase 60 of the needle carrier 18 will penetrate the barrier and open the cavity, and subsequently the pusher 64 will load the disk 28 close to the inner diameter. This will force the disk to pivot around the support 50 and subsequently its inner diameter will expand, thereby releasing the needle carrier 18.
A small clearance at the needle carrier inner hub 52 can be provided which will reverse the above described sequence of releasing and gate opening and at the same time reduce the force required. With the small gap the needle carrier will initially move together with the piston and the only force needed corresponds to the preload of the disk whereas without the gap it must additionally overcome the friction between the needle carrier and disk bore. After the needle carrier is seated the barrier will be penetrated.
It should be further appreciated that during the injection of serum, the inner diameter of disk 28 as press fit on hub 16 at 68 and the circular line contact with the step or shoulder 50 of the barrel form a front seal for chamber 30 whereas the membrane 36 and seal rings such as 32 associated with the piston form a back seal for chamber 30. This assures that all serum in chamber 30 passes through the needle 20. For this reason, the disk 28 is preferably made of a hard rubber or polymeric material such as Polypropylene, Nylon-6 or Acetal.
The piercing surface 60 as shown in
Whereas in the embodiments shown in
In another embodiment shown in
In yet another embodiment, shown in
As shown in the sequence of
Subsequently, as also shown in
The partially assembled syringe is then ready to receive the piston or plunger, which is preferably assembled as shown in
As with the previously described embodiments, the piston 138 is manually displaceable toward the needle assembly 136 through several functional positions. First, the piston 138 forces the serum out of the serum volume through needle 148. This is achieved by compressing the vial 146 until the proximal end of the needle 148 penetrates the vial and continued displacement of the piston empties the vial through the needle. During this injection step, the needle assembly 136 remains in a locked position within the barrel nose 134. This is shown in
The needle assembly 136 has an outer hub 152 and an inner hub 154, as in the previously described embodiment. Preferably, the distal portion 156 of the outer hub 152 defines a seat for spring 160 which is compressed with respect to a distal seat formed in nose 134. The spring 160 as compressed therebetween preloads the needle assembly for displacement toward the piston when the injection has been completed. The proximal end of the outer hub 152 preferably has a central recess 158 from which the proximal end 150 of the needle projects. Upon pressurization of the vial 146, a lobe or the like 146′ conforms to the recess and assures penetration by the needle 150. Preferably, the proximal face of the outer hub 152 defines a piercing surface, preferably with a sharp annular edge such as indicated at 186. This edge does not perforate the membrane 146 during injection.
In the second position the piston urges the membrane 146 against the piercing surface 186 at the conclusion of the injection step. Preferably, the emptied vial is at least partially urged into the piston cavity 142 by the piercing surface 186. In the last step or position, the needle carrier follows at least a portion of the vial into the cavity 142.
During injection and preferably until at least some of the membrane 146 has entered the cavity 142, the needle assembly 136 is held in place by lock member 162 lodged between a tapered or similarly ramped groove 164 near the distal end of the inner hub 154, and a conical or similarly ramped or tapered surface 166 on the distal end of the barrel nose 134. One suitable locking member is shown in
At the same time, or after the injection event, the piston moves the carrier assembly 136 slightly in the distal direction, enabling the compressed locking ring 162 to expand and “jump out” of the groove 164. The spring 160 is now free to act against seat 156, release the needle carrier and displace it into the cavity, thereby withdrawing the needle tip into the distal end of the barrel. The maximum displacement of the piston 138 toward the needle assembly 136 can optionally directly act against the sharp rim 186, thereby cutting a central portion of the membrane out of the vial whereby that central portion of the membrane and the carrier assembly are retracted into the cavity 142.
It should be appreciated that during injection the volume of the vial is reduced corresponding to the reduction in volume of serum contained therein. As a consequence, the membrane begins to deform and eventually collapses. The deformation at the distal end of the vial enables the membrane to enter the recess 158 for penetration by the needle end 150. At the same time, the proximal end of the vial facing the piston also begins to conform to the open end of the cavity 142. The friction between the vial wall and the rand of the piston is sufficient to prevent the vial from completely entering the cavity until the pressure in the vial has dropped to near zero (because of the serum drain). The vial then becomes flaccid and can fold and be pushed by the retracting needle assembly into the piston cavity together with the needle assembly. To facilitate complete entry of the vial into the cavity, a small venting hole can be provided at the proximal end of the piston cavity. Another option is to shape the contact surface between piston and the vial as several concentric rings and by that increase friction to prevent the vial from entering the piston cavity before all or nearly all of the serum has been injected. Another possibility would be to configure and size the cutting edge 186 and the ID of the piston cavity in such a way that when the piston reaches its fully inserted (bottom) position, the vial will be sheared off. With reference to
It should be understood that, as used herein, the “piercing surface” at the proximal end of the needle carrier or hub, performs the broad function of assuring that the membrane passes through (or pierces) the piston cavity opening and thus enters the cavity. In some embodiments, a membrane at the opening is merely cut, whereas in other embodiments all or part of the membrane is pushed into the cavity.
However if the disk 170 is provided with inner and outer cut outs 172, 174, installation would be easier while the stronger locking action would be retained. As used herein, “perforations” encompasses cut outs, holes, etc. The inner diameter edge 176 need not be stretched but merely bent around the shelf 50 in the barrel. In a similar manner the outer diameter edge 178 need not be compressed but only bent about the mating diameter of the installation tool 116 during the assembly. The perforations render the disk pressure insensitive, so it can resist maximum vacuum when serum is drawn and also maximum pressure during injection, without collapsing. Such disk provides excellent locking at reduced installation and actuation forces but such disk does not also provide the fluid seal function at the front of the serum chamber.
As shown in
The strongest advantage of this perforated metal disk is that by being absolutely insensitive to internal pressure, it will not release the needle carrier regardless internal pressure, but it will be released by the full distal displacement of the piston.