SAFETY PEN NEEDLE ASSEMBLY
A safety pen needle assembly includes a hub with a needle fixed to the hub, the needle having a distal end, formed for insertion into a patient, and a proximal end, a shield and a biasing member disposed between the hub and the shield configured to urge the shield distally. The shield is movable from a first position, when the needle is exposed, to a second position, when the needle is covered. The distal end of the needle may be initially exposed to permit visual confirmation of priming, while allowing the shield to cover a majority of the needle to minimize any needle-related anxiety.
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This application is a continuation application of U.S. patent application Ser. No. 16/570,643, filed Sep. 13, 2019, which is a divisional application of U.S. patent application Ser. No. 13/058,649, filed on Mar. 15, 2011, which is the U.S. national stage of International Patent Application No. PCT/US2009/054001, filed on Aug. 17, 2009, which claims priority to and the benefit of U.S. Provisional Application No. 61/089,335, filed on Aug. 15, 2008, the disclosures of each of which are incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTIONSafety pen needle assemblies are known in the prior art for providing shielding to a used pen needle to prevent inadvertent “needle sticks” therewith. These assemblies may be “passive”, which operate through normal use of the associated pen injector, or “active”, which require an additional step or steps to operate beyond normal operation of the associated pen injector.
Passive safety pen needle assemblies have been developed in the prior art which utilize a trigger that is activated upon sufficient application of force thereto during an injection procedure. A trigger may be provided which presses against a patient's skin with sufficient displacement of the trigger causing the assembly to activate. The activation of the trigger results in some form of a shield being released which may move distally to a shielding position covering a used needle. With these designs, concerns exist of preventing inadvertent trigger activation.
SUMMARY OF THE INVENTIONIn one aspect, safety pen needle assembly is provided herein which includes a hub with a needle fixed to the hub, the needle having a distal end, formed for insertion into a patient, and a proximal end. The assembly further includes a shield and a biasing member disposed between the hub and the shield configured to urge the shield distally. A protrusion extends from at least one of the hub and the shield with a channel being formed in at least the other of the hub and the shield. The channel is formed to accommodate the protrusion. The shield is movable from a first position to a second position. In the first position, the shield is spaced from the distal end of the needle such that the distal end of the needle is exposed. In the second position, the shield covers the distal end of the needle. The channel guides the protrusion as the shield moves from the first position to the second position. With this arrangement, a shield may be directed to move in a desired path with stability. In addition, the distal end of the needle may be initially exposed to permit visual confirmation of priming, while allowing the shield to cover a majority of the needle to minimize any needle-related anxiety.
These and other features of the invention will be better understood through a study of the following detailed description and accompanying drawings.
With reference to
The hub 12 includes a generally tubular body 24 having spaced apart distal and proximal ends 26, 28. The tubular body 24, preferably in proximity to the proximal end 28, may be provided with a mounting arrangement (e.g., threads; luer) configured for mounting onto the body of a medical injector, e.g., a pen injector. A channel 30 is provided which may be formed in the hub 12 or the shield 14. With reference to
The shield 14 includes a distal end 32, having an aperture 34 (
A protrusion 38 may be provided on the hub 12 or the shield 14, formed to be accommodated in the channel 30. With reference to the embodiment of
Prior to use, the shield 14 is configured to be in an initial pre-use state. In this pre-use state, the shield 14 may be configured to cover the distal end 20 of the needle 18 (
During use, the shield 14 is caused to move proximally while pressed against a patient's skin, against the force of the biasing element 16. With sufficient pressure, the needle 18, passing through the aperture 34, enters the patient's skin the required depth and an injection is administered as is well known in the art. The shield 14 is urged proximally during this procedure. During this proximal movement, the protrusion 38 is guided by the channel 30. After injection, and removal of the shield 14 from the patient, the biasing element 16 urges the shield 14 distally to a position where the distal end 20 of the needle 18 is covered. The safety pen needle assembly 10 may be provided with a locking arrangement to lock the shield 14 in the final, shielded position covering the distal end 20. As appreciated by those skilled in the art, various locking arrangements are useable with the subject invention.
By way of non-limiting example, and with reference to
Upon the shield 14 being removed from a patient's skin, the biasing element 16 causes the shield 14 to move distally. As a result, the flexible finger 40 deflects the protrusion 38 into a second part 48 of the channel 30 (
To permit the distal end 20 of the needle 18 to be initially exposed, but later fully shielded, the locking aperture 50 may be located to be more distal of the distalmost portion of the first part 46 of the channel 30, as shown in
As will be appreciated by those skilled in the art, any number of protrusions 38 and the channels 30 may be used consistent with the subject invention. Likewise, any number of elements discussed with respect to the other features may likewise be used in various quantities in conjunction with the subject invention.
Further, as will be appreciated by those skilled in the art, the protrusion 38 may be formed on the hub 12 with the channel 30 being formed on the shield 14, for example, as shown in
In an alternate configuration, and with reference to
With reference to
With reference to
The arrangements of
The safety pen needle assembly 10 may be configured to have an automatically rotating arrangement where the shield 14 moves rotationally relative to the hub 12, such as to achieve locking, without manual intervention beyond the normal injection procedure. With reference to
As will be appreciated by those skilled in the art, the shape of the channel 30 directs the rotation of the shield 14. With reference to
With reference to
As depicted in
The channels 30 may be provided in a repeated pattern with like configurations. As shown in
Angled surface 39c may be provided to restrict backward movement of the protrusion 38A (and possibly movement out of a locked position). To enhance this restrictive effect, gap 41 may be defined adjacent to the angled surface 39c. Preferably, the gap 41 is smaller than the diameter of the protrusion 38A. In addition, the stationary finger 64 and/or the angled surface 39c may be defined to be deflectable, as shown in dashed lines. By being formed deflectable, the stationary finger 64 and the angled surface 39c further resist backward movement of the protrusions 38A, 38B.
In some embodiments, as set forth in
As will be appreciated by those skilled in the art, the safety pen needle assembly 10 may be utilized with other features, including a shielding arrangement for shielding the proximal end 22 of the needle 18 after use. With reference to
Preferably, the detent 72 includes a ramped surface 74 which faces generally distally. An angled engagement surface 76 is formed on the proximal end 36 of the shield 14 in axial alignment with the ramped surface 74. The ramped surface 74 and the engagement surface 76 are configured and arranged such that, upon sufficient proximal movement of the shield 14, the engagement surface 76 presses against the ramped surface 74 and causes outward displacement of the ramped surface 74. With sufficient outward displacement, the detent 72 unlatches from the bulkhead 70. The biasing element 16 may be located between the locking arms 68 and the shield 14 such as in a retaining channel 78. With the locking arms 68 being unlatched, the secondary shield 66 is free to move proximally under force of the biasing element 16. As shown in
In addition, as shown in
With reference to
As shown in
As will be appreciated by those skilled in the art, the leafspring 100 may be formed of various materials which provide internal resilience to urge the leafspring 100 to the shielding state. Preferably, the leafspring 100 is formed of a thermoplastic material and more preferably formed unitarily with the hub 12. Biasing force to urge the leafspring 100 to the shielding state may be generated about junction 104 formed at the intersection of the leafspring 100 and the pen needle assembly 10. Preferably, free end 106 of the leafspring 100 biases outwardly upon rupture of the connection 102 to be clear of other portions of the pen needle assembly 10. In this manner, the free end 106 is urged by the biasing force generated about the junction 104 to cover the proximal end 22 of the needle 18.
Preferably, the various locking apertures or windows discussed above for receiving in snap engagement a locking element (e.g., the locking aperture 50; the locking window 60) are preferably through holes which extend through a respective surface to permit visual confirmation of a locked arrangement from an external vantage point. The apertures or windows may be formed blind with limited depth so as to not fully extend through a respective surface. This is less desirable since visual confirmation may not be achievable. However, an audible or tactile click may be relied to indicate snap engagement.
As depicted in
In this embodiment, as the distal end 20 of the needle 18 is inserted into the skin of the patient, the outer shield assembly 120 is pressed by a patient's skin and moved away from the distal end 20 of the needle 108 down the outer surface 128 of the assembly. As the outer shield assembly 120 is pressed down by the patient's skin, the depth markings 126 are likewise pressed down away from the distal end 110 of the needle 18. The user can thus view the depth markings 126 as the needle 18 is inserted into the skin, or after injection, and determine the proper insertion depth for the needle 18.
If desired, the outer shield assembly 120 may provide a shield for the distal end 110 of the needle 18 after use. The shield portion 124 may be formed to cover the distal end 110 of the needle 18. The shield portion 124 may be manually adjusted after use to cover the distal end 20. Preferably, the outer shield assembly 120 includes a spring 130, which biases the outer shield assembly 120 along the outer surface 128 of the assembly towards the distal end 20 of the needle 18. Prior to use, the outer shield assembly 120 may be disposed such that the distal end 20 of the needle 18 is exposed (
It will be understood by those of skill in the art that the cylinder 122 need not have a circular cross-section, rather it may be oval, ellipsoidal, or any other shape that matches up to the outer surface 128 of the assembly. For example, the cylinder 122 may be crescent shaped so as to aid in the sliding engagement with the outer surface 128 of the assembly. Further, the shield 124 need not completely surround the needle, and may include two prong-like arms that extend alongside the distal end 110 of the needle 108, preventing accidental contact.
The depth markings 126 may include a series of markings on the cylinder 122, or may include one single depth mark that is used to indicate that the needle 18 has been inserted the proper depth into the patient. Alternatively, a single depth mark may indicate that the needle 18 has been inserted a sufficient distance to engage the safety mechanism of the outer shield assembly 120 (i.e., the spring has been depressed enough to allow the shield portion 124 to cover the distal end 20 of the needle). The depth markings 126 may be etched into the cylinder 122, or they may be drawn onto the cylinder 122 with ink or any suitable material.
In an alternate embodiment, the outer shield assembly 120 may include an additional protruding member parallel to the cylinder 122 such that the outer shield assembly 120 rests along the outside of the hub. In this case, the hub may be restrained and move between the cylinder 122 and protrusions.
As will be appreciated by those skilled in the art, the various features described herein may be used in various combinations. For example, and with reference to
Claims
1-6. (canceled)
7. A safety pen needle assembly comprising:
- a hub;
- a needle fixed to the hub, the needle having a distal end formed for insertion into a patient and a proximal end;
- a shield; and
- a biasing means disposed between the hub and the shield configured to urge the shield distally, wherein:
- a protrusion extends from at least one of the hub and the shield, and a channel is formed in at least the other of the hub and the shield, the channel formed to accommodate the protrusion;
- the shield is movable from a first position to a second position, wherein: in the first position, the shield covers the distal end of the needle; in the second position, the distal end of the needle is exposed; and the channel guides the protrusion as the shield moves from the first position to the second position; and
- the shield is initially in a locked state with the protrusion being spaced from the channel, the shield being manually movable out of the locked state to urge the protrusion into the channel thereby allowing the shield to move from the first position to the second position.
8. The safety pen needle assembly of claim 7, wherein a locking aperture is formed in the at least the other of the hub and the shield and is spaced from the channel, the locking aperture formed to accommodate the protrusion in snap engagement in the locked state.
9. The safety pen needle assembly of claim 8, wherein the locking aperture is circumferentially offset from the channel.
10. The safety pen needle assembly of claim 8, wherein the locking aperture is longitudinally offset from the channel.
11. The safety pen needle assembly of claim 7, wherein the shield is rotatable out of the locked state.
12. The safety pen needle assembly of claim 7, wherein the shield is axially displaceable out of the locked state.
13. The safety pen needle assembly of claim 7, wherein:
- the channel comprises a first part and a second part; and
- a locking aperture is formed in the at least the other of the hub and the shield, the locking aperture being formed to receive the protrusion.
14. The safety pen needle assembly of claim 13, wherein a ridge separates the locking aperture and the channel.
15. The safety pen needle assembly of claim 13, wherein:
- in the first position, the protrusion is received in the locking aperture and engaging the locking aperture at a location more distal than a distal most portion of the first part of the channel; and
- in the second position, the protrusion is seated in a first location and engages the distal most portion of the first part of the channel to retain the shield spaced from the distal end of the needle.
16. The safety pen needle assembly of claim 7, further comprising a second channel formed in the at least the other of the hub and the shield, wherein:
- the channel is parallel to a longitudinal axis of the safety pen needle assembly;
- the second channel is disposed transversely to and in communication with the channel; and
- the shield is initially in a locked state with the protrusion positioned in the second channel, the shield being manually rotatable out of the locked state to urge the protrusion from the second channel into the channel thereby allowing the shield to move from the first position to the second position.
17. A method, comprising:
- manually moving a shield of a pen needle assembly out of a locked state where the shield covers a distal end of a needle of the pen needle assembly; and
- applying the pen needle assembly to skin of a patient such that the shield is depressed by the skin of the patient, wherein depression of the shield exposes the distal end of the needle.
18. The method of claim 17, wherein moving the shield out of the locked state comprises rotating the shield out of the locked state.
19. The method of claim 17, wherein moving the shield out of the locked state comprises axially displacing the shield out of the locked state.
20. The method of claim 17, wherein:
- manually moving the shield out of the locked state comprises moving the shield to a first position where the shield covers the distal end of the needle; and
- depression of the shield comprises the shield moving from the first position to a second position where the shield exposes the distal end of the needle.
21. The method of claim 20, wherein the pen needle assembly comprises:
- a hub, wherein the needle is fixed to the hub;
- a protrusion extending from at least one of the hub and the shield; and
- a channel formed in at least the other of the hub and the shield, the channel formed to accommodate the protrusion, wherein: the protrusion is spaced from the channel when the shield is in the locked state; and manually moving the shield out of the locked state further comprises moving the protrusion into the channel, wherein the channel guides the protrusion as the shield moves from the first position to the second position.
22. The method of claim 21, wherein:
- manually moving the shield out of the locked state comprises moving the protrusion from a locking aperture formed in the at least the other of the hub and the shield into the channel; and
- the locking aperture is separated from the channel by a ridge.
23. A medical injector comprising:
- a needle; and
- a slidable body disposed adjacent to the needle, the slidable body having depth marks defined thereon, wherein: during an injection of the needle into a patient, the slidable body is depressed by skin of the patient; and the depth marks indicate an extent of depression of the slidable body during the injection thereby providing an indication of a depth of injection by the needle.
24. The medical injector of claim 23, wherein the slidable body comprises:
- a slidable first member slidably attached and in contact with an outer surface of a portion of the medical injector at a portion offset from an axis of the needle, wherein the depth marks are defined on the slidable first member; and
- a shield portion connected to a distal end of the slidable first member, wherein during the injection of the needle into the patient, the shield portion is depressed by the skin of the patient.
25. The medical injector of claim 23, wherein the slidable body is configured as a shape, having a non-circular cross-section, that matches up to an outer surface of the medical injector and is slidably attached to only a part of the outer surface of the medical injector at a portion offset from an axis of the needle.
26. The medical injector of claim 23, wherein:
- the slidable body is slidably attached to an outer surface of a hub from which the needle protrudes; and
- the slidable body includes a small diameter cylinder offset from an axis of the needle, wherein: the cylinder extends from a distal surface of the hub; and a shield portion is at a top of the cylinder.
Type: Application
Filed: Jun 27, 2022
Publication Date: Dec 15, 2022
Applicant: Embecta Corp. (Andover, MA)
Inventors: Tieming Ruan (Belmont, MA), Robert Banik (Edgewater, NJ), Eliot Zaiken (Covington, GA), Michael Vincent Quinn (East Hanover, NJ), Gary Searle (Norfolk, MA)
Application Number: 17/850,236