Safety shield system for a syringe
A medical device includes a syringe assembly and a shield system for delivering medicament to a patient. The syringe assembly includes a barrel defining a medicament reservoir, and a needle cannula coupled to the barrel and in fluid communication with the reservoir. The shield system has a hub coupled to the syringe barrel, a shield movably arranged on the hub, the shield being movable from a first position disposed from the needle cannula tip to a second position during insertion of the needle into a patient and movable from the second position to a third position covering the needle cannula tip after the needle cannula is removed from the patient. An urging member urges the shield to the third position upon removal of the needle cannula from the patient. A cover sleeve connected to the needle barrel surrounds the hub and the urging member.
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1. Field of the Invention
The present invention relates to a prefilled medical device for delivering a dose of medicament by injection and having an integral shield system for preventing accidental needle sticks after use.
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 may contain 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. Some such shields are spring activated for imparting a telescoping-like deployment action to the safety shield. 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 shield deployment, 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.
SUMMARY OF THE INVENTIONThe present invention relates to a medical device including a syringe assembly and incorporating a safety shield for covering the needle of the syringe assembly after administration of a dosage of medicament. The safety shield is automatically activated upon insertion of the needle of the syringe to a medicament delivery depth in a patient.
According to the present invention, the medical device for delivering a medicament to a patient includes a syringe having a barrel with a forward end and a rear end and defining a reservoir within which the medicament may be contained. As used herein, the term “forward,” when used to describe the medical device and its various parts, refers to a part of the device that is closer to the patient. As used herein, the term “rear” or “rearward,” when used to describe the medical device and its various parts, refers to a part of the device that is closer to the health care professional using the medical device. A needle or needle cannula (those terms being used interchangeably herein) having a forward tip is provided proximate the forward end of the barrel and is in fluid communication with the reservoir. A hub is connected to or provided on the barrel. A shield is movably mounted on the hub at a first position in which a part of the needle cannula is contained within the shield and, preferably, the tip of the needle cannula is not contained within the shield. An urging member is arranged between the hub and the shield for urging the shield toward the first position. The urging member may be, by way of non-limiting example, a coil spring, and is arranged on an exterior of the hub. The shield is movable from the first position to a second position against the influence or urgency of the urging member when the needle cannula is inserted into a patient for delivery of the medicament by interaction with the patient's skin. After delivery of the medicament, the shield is moveable from the second position to a third position, by the urgency of the urging member, upon removal of the needle cannula from the patient. When the shield is in the third position, the forward tip of the needle cannula is covered by the shield by a sufficient amount to prevent the tip of a finger from contacting the needle tip. As explained below, the shield may be secured in the third position to prevent the needle from being exposed after use.
A cover sleeve is mounted on the hub or the barrel and covers the portion of the urging member that extends between the shield and the hub in each of the first, second, and third positions of the shield. The cover sleeve may include a retainer arranged proximate a front end of the cover sleeve for interacting with a structure on the shield and blocking forward movement of the shield when the shield is in the third position. This feature prevents the shield from being removed from the device. The cover sleeve may additionally or alternatively include a projection between the two ends thereof for interacting with a resilient portion of the shield for blocking rearward movement of the shield when the shield is in the third position. The cover sleeve and shield may further include complementary interacting structures for preventing rotation of the shield relative to the cover sleeve when the shield is in the third position.
The hub may include a needle guide arranged proximate a forward end thereof. The needle guide may be formed unitarily as one piece with the hub and may also define a guide hole for radially supporting the needle cannula. Alternatively, the needle guide may comprise a separate piece having catches for forming a connection with the hub and a grip portion for providing radial support to the needle when the needle guide is connected to the hub.
The hub defines a track arrangement having an entry track and a lock-out track. The shield includes a pin mounted on a lever arm which is guidably received in the track arrangement. The entry track and the lock-out track are joined at an intersection. The pin is guided by the entry track when the shield moves from the first position to the second position and the pin is guided by the lock-out track when the shield moves from the second position to the third position.
The flexible arm may include a recess for reducing a force required to flex the lever arm. Alternatively, the flexible arm may include a spine along its axial length to increase a strength of the flexible arm. Ideally, the flexible arm includes both a recess at the junction of the flexible arm with the shield to reduce the force required to flex the arm when locking into the third position, and a spine along the flexible arm to increase the strength of the flexible arm in compression.
The medical device of the present invention may also include a locking device for locking the shield in the third position. The locking device may comprise an element that is similar to the blocking element having an inclined surface for facilitating movement of the pin in one direction, i.e. along the lock-out track to a fully-deployed position of the shield, and blocking movement of the pin in the reverse direction. The pin may have a tangentially inclined face interacting with the locking device when the shield is in the third position.
The lock-out track may extend parallel to the longitudinal axis of the medical device and the entry track may extend at least partially in the circumferential direction such that the shield rotates with respect to the longitudinal axis as the shield moves from the first position to the second position. Alternatively, the entry track may extend parallel to the longitudinal axis of the medical device and the lock-out track may extend at least partially in the circumferential direction such that the shield rotates with respect to the longitudinal axis as the shield moves from the second position to the third position. As a further alternative, both the entry track and the lock-out track may extend at least partially in the circumferential direction, such that the shield rotates as it moves from the first position to the second position and from the second position to the third position.
The cover sleeve may include a narrowed cylindrical portion for receiving a needle cover. The needle cover and the narrowed cylindrical portion may include corresponding structures for securing the needle to the needle cover during storage and/or for facilitating axial movement of the needle cover in response to twisting of the needle cover.
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 syringe 20 includes a cylindrical barrel 24 defining a reservoir 25 (see
As further shown in
As described below, the shield 22 is movable from an initial or first position, in which the forward tip 126 of the needle cannula 26 extends beyond a front end 122 of the shield 22, to an intermediate or second position, and then from the intermediate position to a shielded or third position in which the forward tip 126 of the needle cannula 26 is contained within the shield body 22. An urging member 42, such as, for example, a coil spring or biasing arm, urges the shield forward relative to the barrel 24. Thus, the urging member 42 maintains the shield 22 in the first position prior to use, and urges or causes the shield 22 to move from the second position to the third position.
The various component parts of the inventive medical device 10 will now be discussed in further detail. The shield 22 is depicted in
The front end portion 60 of the barrel 24 is shown in
Prior to use of the medical device 10, the removable needle shield 27 is separated from the medical device 10. At this stage, the shield 22 is in the position, as shown in
As the needle cannula 26 is inserted into a patient to deliver the medicament, the front end 122 of the shield 22 contacts the skin 80 of the patient, as depicted in
After the medicament is delivered, the needle cannula 26 is removed from the patient. This provides clearance for the shield 22, whereupon the shield 22 is then urged, by the force of the compressed urging member 42, to a third position in which the shield body 22 extends beyond the forward tip 126 of the needle cannula 26. As shown in
In the embodiment of
A description of an exemplary usage of the medical device 10 of the present invention will now be provided with respect to
Once the needle cannula 26 is fully inserted into the patient, the health care professional depresses the thumb pad 32 to cause the plunger rod 28 and piston 30 to move within the reservoir 25. As the plunger rod 28 and piston 30 are moved into the reservoir, the medicament is caused to be expelled from the reservoir 25, through the needle cannula 26, and into the patient. After delivery of the medicament, the health care professional withdraws the needle cannula 26 from the patient. As the needle cannula is withdrawn, the urging member urges the shield 22 forward until the shield 22 reaches the third position when the needle cannula 26 is completely withdrawn and in which the shield 22 covers the forward tip 126 of the needle cannula 26, thus preventing undesired and inadvertent exposure of the health care professional to the contaminated forward tip 126. The used medical device may then be disposed of in a suitable sharps disposal container.
Similarly to the above-described embodiments of
As described in the previous embodiments, the shield 622 is in a first or initial position prior to use of the medical device 600 in which the pins 638 of the lever arms 636 are in the entry tracks 664. A forward tip of the needle cannula may or may not be covered by the shield when it is in the first or initial position. After the needle cover 627 is removed and the needle cannula is inserted in the patient, the shield 622 contacts the patients skin and is pushed toward the syringe barrel 624 against the influence of the urging member 642. During this movement, the pins 638 move over entry steps 668 into a second or central position in lock-out tracks 662. When the needle cannula 626 is removed from a patient, the force of urging member 642 pushes the shield so that the pins 638 move along the lock-out track 662 over lock-out steps 666 to the third or shielded position in which the shield extends past the end of the needle cannula 626. Lock out step 666 is similar to lock out step 66 in
The embodiment of
As shown in
The rearward portion 723 of the shield 622 may be cylindrical. Alternatively, the rearward portion 723 of the shield may include a plurality of circumferentially spaced resilient legs 728, each including one of the projections 724. The legs 728 are urged inwardly toward the needle cannula 626 as the projections 724 pass over the ring 685 when the shield is moved along the lock-out track toward the third position. The legs 728 resiliently snap radially outward once the projection 724 pass over the ring 685 and the shield 622 is in the third position. The rear ends of the projections 724 interact with the ring 685 in the third position of the shield 622 so that the shield 622 is prevented from moving rearward. As shown in
In a further embodiment shown in
Instead of being funnel-shaped, the stabilizer may include plural legs or elements 809 extending radially inward from the front end of the hub 661 and forming a partial funnel as shown in
In each of the above embodiments of the inventive medical devices 10, 300, 600, the lever arms 36, 336, 636 may include a recess 902 between the connection point and the free end thereof to increase the flexibility of the lever arm as shown, for example, in
To increase the beam buckling strength of the lever arm 636, the free end of the lever arm 636 may include a tangentially inclined surface 1003, 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.
Claims
1. A medical syringe for delivering a medicament to a patient, comprising:
- a syringe assembly comprising a barrel having a forward end and a rear end and defining a reservoir within which a medicament may be contained, and a needle cannula having a forward tip and being coupled to said forward end of said barrel and in fluid communication with said reservoir;
- a hub provided on said forward end of said barrel, said hub having a rear end and a front end;
- a shield movably mounted on said hub at a first position;
- an urging member for urging said shield in a forward direction relative to said barrel; and
- a cover sleeve having a rear end connected to one of said hub and said barrel, and a front end, said cover sleeve radially surrounding at least a portion of said hub, said shield being movable from said first position to a second position against the urgency of said urging member when said needle cannula is inserted into a patient for delivery of the medicament and said shield being moveable from said second position to a third position by the influence of said urging member upon removal of said needle cannula from said patient, wherein said shield is locked in said third position and said forward tip of said needle cannula is covered by said shield when said shield is in said third position,
- wherein one of said hub and said shield defines a track arrangement having an entry track and a lock-out track, said entry track and said lock-out track being joined at an intersection, and the other of said hub and said shield includes a pin arranged on a flexible lever arm, said flexible lever arm having a base end connected to the other of said hub and said shield and a free end, said pin being arranged proximate said free end of said flexible lever arm and guidable in said track arrangement during movement of the shield between said first, second, and third positions.
2. The medical syringe of claim 1, wherein said cover sleeve and said hub are each independently connected to said barrel.
3. The medical syringe of claim 1, wherein said urging member is a coil spring arranged in the annular space between said hub and said cover sleeve.
4. The medical syringe of claim 1, wherein said cover sleeve includes a retainer arranged proximate said front end of said cover sleeve, said retainer comprising a radially inward projection interacting with a structure on said shield for blocking forward movement of said shield when said shield is in said third position.
5. The medical syringe of claim 4, wherein said retainer comprises a projection having circumferential sides and said shield comprises at least one axially extending projection arranged and dimensioned for interacting with one of said circumferential sides of said retainer to prevent said shield from rotating relative to said cover sleeve when said shield is in said third position.
6. The medical syringe of claim 4, wherein one of said shield and said cover sleeve comprises a projection and the other of said shield and said cover sleeve comprises a corresponding structure which is arranged and dimensioned for interacting with said projection for preventing said shield from rotating relative to said cover sleeve when said shield is in said third position.
7. The medical syringe of claim 1, wherein one of said shield and said cover sleeve comprises a projection and the other of said shield and said cover sleeve comprises a corresponding structure which is arranged and dimensioned for interacting with said projection for preventing said shield from rotating relative to said cover sleeve when said shield is in said third position.
8. The medical syringe of claim 1, wherein said cover sleeve comprises a first radially inward projection arranged between said front and rear ends of said cover sleeve, said shield comprising a resilient portion interacting with said projection for blocking rearward movement of said shield from said third position.
9. The medical syringe of claim 8, wherein said resilient portion comprises a flexible leg arranged on a rear portion of said shield.
10. The medical syringe of claim 9, wherein said flexible leg comprises a radial outward projection interacting with said first radially inward projection on said cover sleeve, said first radially inward projection on said cover sleeve comprising an annular ring.
11. The medical syringe of claim 10, wherein said cover sleeve includes a retainer arranged proximate said front end of said cover sleeve, said retainer comprising a second radially inward projection interacting with a structure on said shield for blocking forward movement of said shield when said shield is in said third position.
12. The medical syringe of claim 1, wherein said hub comprises a cylindrical extension, said cylindrical extension further comprising a needle guide arranged proximate said front end and defining a guide hole through which said needle cannula extends for radially supporting said needle cannula.
13. The medical syringe of claim 12, wherein said needle guide comprises a radially inward extending guide portion formed integrally as one piece with said cylindrical extension and defining said guide hole such that a diameter of said guide hole corresponds to a diameter of said needle cannula.
14. The medical syringe of claim 13, wherein said needle guide further comprises an inner cylinder connected to said guide portion and extending axially toward said rear end of said hub, said inner cylinder having an inner diameter corresponding to said diameter of said needle cannula.
15. The medical syringe of claim 12, wherein said needle guide comprises a plurality of elements extending radially inward at said front end of said cylindrical section for radially supporting said needle cannula.
16. The medical syringe of claim 12, wherein said needle guide comprises a guide element having catches arranged and dimensioned for forming one of a snap-fit and friction-fit connection in said guide hole, said needle guide further comprising a grip portion arranged and dimensioned for providing radial support to said needle cannula when said needle guide is connected in said guide hole.
17. The medical syringe of claim 1, wherein said hub defines said track arrangement, and said shield includes said pin.
18. The medical syringe of claim 17, wherein said lever arm comprises one of a recess between said base end and said free end defining a narrow portion of said flexible lever arm for reducing a force required to flex the flexible lever arm, and a spine along an axial length of said flexible lever arm to increase a strength of said flexible lever arm.
19. The medical syringe of claim 17, wherein said shield further comprises lateral projections facing opposing circumferential sides of said flexible lever arm such that said flexible lever arm abuts one of said lateral projections in response to torque on said shield to prevent rotation of said shield relative to said hub.
20. The medical syringe of claim 17, wherein said lock-out track includes a lock-out step blocking movement of said pin when said shield is in said third position, said free end of said flexible lever arm including a tangentially inclined surface facing said lock-out step when said shield is in said third position.
21. The medical syringe of claim 1, further comprising a reinforcement collar arranged on said shield for providing radial support for preventing the flexible lever arm from buckling radially outward.
22. The medical syringe of claim 21, wherein said reinforcement collar further comprises tangential supports for said flexible lever arm.
23. The medical syringe of claim 1, further comprising a needle cover, wherein said cover sleeve comprises a cylindrical portion for receiving said needle cover.
24. The medical syringe of claim 23, wherein one of said needle cover and said cylindrical portion comprises a projection and the other of said needle cover and said cylindrical portion comprises a recess corresponding to said projection for engaging said projection when said needle cover is received on said cover sleeve.
25. The medical syringe of claim 24, wherein said projection and recess are arranged and dimensioned for one of securing said needle cover on said cover sleeve and causing axial movement of said needle cover relative to said cover sleeve in response to twisting of said needle cover.
26. The medical syringe of claim 25, wherein one of said needle cover and said reduced diameter section comprise sealing rings for creating a seal between said needle cover and said reduced diameter section.
27. The medical syringe of claim 1, wherein said barrel, said hub, said cover sleeve, and said shield are made of plastic.
28. The medical syringe of claim 27, wherein said barrel and said hub are unitarily formed.
29. The medical syringe of claim 1, wherein said barrel and said hub are made of different materials.
30. A shield assembly for connection to a syringe barrel for preventing inadvertent needle sticks after use of the syringe, the shield assembly comprising a hub provided on a forward end of the syringe barrel, said hub having a rear end and a front end, a shield movably mounted on said hub at a first position, and an urging member for urging said shield in a forward direction relative to said barrel, and a cover sleeve having a rear end connected to one of said hub and the syringe barrel and a front end, said cover sleeve radially surrounding at least a portion of said hub, said shield being movable from said first position to a second position against the influence of said urging member when said needle cannula is inserted into a patient for delivery of the medicament and said shield being moveable from said second position to a third position by the urgency of said urging member upon removal of said needle cannula from said patient, wherein said shield is locked in said third position and said forward tip of said needle cannula is covered by said shield when said shield is in said third position, wherein one of said hub and said shield defines a track arrangement having an entry track and a lock-out track, said entry track and said lock-out track being joined at an intersection, and the other of said hub and said shield includes a pin arranged on a flexible lever arm, said flexible lever arm having a base end connected to the other of said hub and said shield and a free end, said pin being arranged proximate said free end of said flexible lever arm and guidable in said track arrangement during movement of the shield between said first, second, and third positions.
31. The shield assembly of claim 30, wherein said urging member is arranged in the annular space between said hub and said cover sleeve.
32. The shield assembly of claim 30, wherein said cover sleeve includes a retainer arranged proximate said front end of said cover sleeve, said retainer comprising a radially inward projection interacting with a structure on said shield for blocking forward movement of said shield when said shield is in said third position.
33. The shield assembly of claim 30, wherein one of said shield and said cover sleeve comprises a projection and the other of said shield and said cover sleeve comprises a corresponding structure which is arranged and dimensioned for interacting with said projection for preventing said shield from rotating relative to said cover sleeve when said shield is in said third position.
34. The shield assembly of claim 30, wherein said cover sleeve comprises a first radially inward projection arranged between said front and rear ends of said cover sleeve, said shield comprising a resilient leg interacting with said projection for blocking rearward movement of said shield from said third position.
35. The shield assembly of claim 30, wherein said hub comprises a cylindrical extension, said cylindrical extension further comprising a needle guide arranged proximate said front end and defining a guide hole through which said needle cannula extends for radially supporting said needle cannula.
36. The shield assembly of claim 30, wherein said hub defines said track arrangement, and said shield includes said pin.
37. The shield assembly of claim 36, wherein said lever arm comprises at least one of a recess between said base end and said free end defining a narrow portion of said flexible lever arm for reducing a force required to flex the flexible lever arm, and a spine along an axial length of said flexible lever arm to increase a strength of said flexible lever arm.
38. The shield assembly of claim 36, wherein said shield further comprises lateral projections facing opposing circumferential sides of said flexible lever arm such that said flexible lever arm abuts one of said lateral projections in response to torque on said shield to prevent rotation of said shield relative to said hub.
39. The shield assembly of claim 36, wherein said lock-out track includes a lock-out step blocking movement of said pin when said shield is in said third position, said free end of said flexible lever arm including a tangentially inclined surface facing said lock-out step when said shield is in said third position.
40. The shield assembly of claim 36, further comprising a reinforcement collar arranged on said shield for providing radial support for preventing the flexible lever arm from buckling radially outward.
41. The shield assembly of claim 30, wherein said barrel, said hub, said cover sleeve, and said shield are made of plastic.
42. The shield assembly of claim 40, wherein said barrel and said hub are unitarily formed.
43. The shield assembly of claim 30, wherein said barrel and said hub are made of different materials.
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WO 03/015852 | February 2003 | WO |
WO 03/022335 | March 2003 | WO |
WO 03/033059 | April 2003 | WO |
WO 03/033060 | April 2003 | WO |
WO 03/041766 | May 2003 | WO |
WO 03/045476 | June 2003 | WO |
WO 03/045480 | June 2003 | WO |
WO 03/045481 | June 2003 | WO |
WO 03/063934 | August 2003 | WO |
WO 03/068297 | August 2003 | WO |
WO 03/068298 | August 2003 | WO |
Type: Grant
Filed: Feb 18, 2005
Date of Patent: Jul 19, 2011
Patent Publication Number: 20060189933
Assignee: Becton, Dickinson and Company (Franklin Lakes, NJ)
Inventors: Tom Alheidt (Lake Stockholm, NJ), Vu Phan (Piscataway, NJ), Laurent Barrelle (Saint Nizier du Moucherotte), Bruno Baney (Claix)
Primary Examiner: Kevin C Sirmons
Assistant Examiner: Michael J Anderson
Attorney: Cohen Pontani Lieberman and Pavane LLP
Application Number: 11/061,912
International Classification: A61M 5/00 (20060101); A61M 5/32 (20060101);