Safety disposal needle shield

Abstract

An injection system including a container having a reservoir therein is disclosed. The injection system includes a port coupled to the container and defining a passage therein, a needle at least partially disposed in the passage of the port, and a needle shield enclosing at least a portion of the needle therein, the needle shield rotatable from (i) a first rotational position permitting axial movement between the port and the needle shield, to (ii) a second rotational position preventing axial movement between the port and the needle shield.

Description

SAFETY DISPOSAL NEEDLE SHIELDCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to Indian Patent Application No. 202441079408 entitled “Safety Disposal Needle Shield” filed October 18, 2024, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present disclosure is directed to injection systems, devices, and methods of use thereof, and in particular to needle shields for such injection systems and devices.Description of Related Art

[0003] Medical devices provided with sharp pointed needles are prevalent in the typical daily practice among the medical community in order to perform injections or to take samples. Sharp pointed needles present an inherent risk of needle stick injury for the medical staff and the patients and are thus usually provided with a needle cap covering the needle before use. This cap not only preserves the needle from contamination but also from undesired contacts or punctures that could occur during transport and delivery by the medical staff, with the cap typically removed immediately before use of the medical device.

[0004] However, replacing the needle cap onto the needle after use is regarded as a major cause of accident and contamination for the medical staff with a higher possibility of an unintended needle stick. Moreover, disposing the medical device with an exposed needle or with a cap that may detach from the needle during disposal provides additional risk of unintended injury.

[0005] The present disclosure provides improved injection systems, device, and components thereof to reduce the risk of a needle injury during pre-use, use, and / or disposal of such devices.SUMMARY OF THE INVENTION

[0006] In accordance with one aspect, the present disclosure is directed to an injection system including a container having a reservoir therein, a port coupled to the container and defining a passage therein, a needle at least partially disposed in the passage of the port, and a needle shield enclosing at least a portion of the needle therein, the needle shield rotatable from (i) a first rotational position permitting axial movement between the port and the needle shield, to (ii) a second rotational position preventing axial movement between the port and the needle shield.

[0007] In certain configurations, the needle is movable with respect to the port. The injection system may further include a needle hub surrounding a portion of the needle, wherein the needle hub is axially movable within the passage. In certain configurations, the port includes a barrier therein separating the passage into a first compartment and a second compartment. The first compartment may be in fluid communication with the reservoir.

[0008] In certain configurations, a proximal end of the needle is movable from (i) a first position in the second compartment to (ii) a second position in the first compartment and in fluid communication with the reservoir. The proximal end of the needle may be configured to pierce the barrier in moving from the first position to the second position. The injection system may further include a valve positioned between the reservoir and the needle. The valve may be a oneway valve permitting fluid flow from the reservoir to the needle, and preventing fluid flow form the needle to the reservoir.

[0009] In certain configurations, the port defines one or more channels on an interior surface thereof, and wherein the needle shield includes one or more protrusions on an exterior surface thereof, the one or more protrusion each movably positionable in the one or more channels. Each of the one or more channels may be axially-aligned along a length of the port. In other configurations, each of the one or more protrusions is movable with respect to the exterior surface of the needle shield.

[0010] In certain configurations, the injection system may further include a locking element circumferentially adjacent to each of the one or more channels, the locking element configured to permit rotation of the needle shield from the first rotational position to the second rotational position, and prevent rotation of the needle shield from the second rotational position to the firstrotational position. The locking element may include at least one of a sloped surface, a ramped surface, or an arcuate surface.

[0011] In accordance with an embodiment of the present invention, an injection system includes a container having a reservoir therein, a port coupled to the container and defining a passage therein, with the port defining a channel extending axially along an interior surface thereof. The injection system also includes a recess adjacent to the channel, a needle at least partially disposed in the passage of the port, and a needle shield enclosing at least a portion of the needle therein, the needle shield including a protrusion on an exterior surface thereof, the needle shield rotatable from (i) a first rotational position in which the protrusion is at least partially positioned within the channel to permit axial movement between the port and the needle shield, to (ii) a second rotational position in which the protrusion is at least partially positioned within the recess to prevent axial movement between the port and the needle shield.

[0012] In certain configurations, the injection system also includes a locking element positioned between the channel and the recess, wherein the protrusion traverses the locking element to move from the first rotational position to the second rotational position. In certain configurations, the protrusion is movable with respect to the exterior surface of the needle shield, and wherein traversing the locking element moves the protrusion with respect to the exterior surface of the needle shield. The protrusion may form at least one of a cantilever joint or a living hinge with the exterior surface of the needle shield.

[0013] In certain configurations, the locking element is configured to permit rotation of the needle shield from the first rotational position to the second rotational position, and prevent rotation of the needle shield from the second rotational position to the first rotational position. The locking element may include at least one of a sloped surface, a ramped surface, or an arcuate surface.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0015] Fig 1 is a perspective view of an example of an injection system constructed in accordance with the principles of the present invention;

[0016] Fig. 2 is a cross-sectional view of the injection system of Fig. 1 with a needle assembly in a first position;

[0017] Fig 3 is a cross-sectional view of the injection system of Fig. 1 with a needle assembly in a second position;

[0018] Fig 4 is a cross-sectional view of an example of a port for an injection system constructed in accordance with the principles of the present invention;

[0019] Fig 5 is a distal-to-proximal end view of the port of Fig. 4;

[0020] Fig 6 is a perspective view of an example of a needle shield for an injection system constructed in accordance with the principles of the present invention;

[0021] Fig 7 is a distal-to-proximal end view of the needle shield of Fig. 6;

[0022] Fig 8 is a perspective view of an example of an injection system constructed in accordance with the principles of the present invention with a needle shield attached and detached therefrom;

[0023] Fig 9 is a cross-sectional view of an example of an injection system with a needle shield in a first rotational position with respect to a port; and

[0024] Fig 10 is a cross-sectional view of the injection system of Fig. 9 with a needle shield in a second rotational position with respect to a port.DESCRIPTION OF THE INVENTION

[0025] The following description is provided to enable those skilled in the art to make and use the described embodiments contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0026] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the concept as it is oriented in the drawing figures. As used herein, the distal end of a component or of a device is to be understood as meaning the end furthest from the user’s hand,and the proximal end is to be understood as meaning the end closest to the user’s hand. However, it is to be understood that the concept may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the concept. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.

[0027] The word “comprising” and “comprises”, and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. In the present specification, “comprises” means “includes” and “comprising” means “including.”

[0028] As used herein, “at least one of’ is synonymous with “one or more of.” For example, the phrase “at least one of A, B, or C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.

[0029] The term “at least” is synonymous with “greater than or equal to.” The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements. As used herein, the singular form of “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.

[0030] All numbers used in the specification and claims are to be understood as being modified in all instances by the term “about”. By “about” is meant within plus or minus twenty-five percent of the stated value. However, this should not be considered as limiting to any analysis of the values under the doctrine of equivalents.

[0031] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent the average values over the specified range and / or ratio.

[0032] Reference is now made to Figs. 1-3 which show an example of an injection system, generally indicated as 10. The injection system 10 may include a container 12 defining a reservoir14 therein configured to contain a fluid or substance. In one example the container 12 may include or define a disposable and / or prefillable dosage device. In one example, the reservoir 14 may include or define a depressible volume and / or surface operable or configured to dispense a fluid, medicament, and / or other substance from the reservoir 14.

[0033] Now referring to Figs. 1-5, the injection system 10 may include a port 16 coupled to and / or integral with the container 12. The port 16 may be operable and / or configured to provide access to and / or fluid communication with the reservoir 14. For example, the port may include or define a proximal end 18, a distal end 20, and a passage 22 extending at least partially therethrough. The proximal end 18 may be positioned adjacent to an edge or circumference of the reservoir 14. The port 16 may include or define a barrier 24 disposed within the passage 22 that seals a portion of the passage 22. For example, the barrier 24 may be axially positioned between the proximal end 18 and the distal end 20 to define a first compartment 26 of the passage 22 fluidically sealed or isolated from a second compartment 28 of the passage. The first compartment 26 may be in fluid communication with the reservoir 14.

[0034] As shown in Figs. 1-3, The injection system 10 may include or define a valve 30 positioned between the first compartment 26 and the reservoir 14. The valve 30 may be configured and / or operable to enable fluid flow in a single direction from the reservoir 14 towards the first compartment 26 and / or passage 22 of the port 16, while preventing fluid flow in an opposite direction from the first compartment 26 and / or passage 22 of the port 16 towards the reservoir 14. The valve 30 may include, for example, a check valve with one or more unidirectional mechanisms to enable and provide the features disclosed herein. The valve 30 may prevent re-filing of the reservoir 14 after delivering or injecting the contents thereof to ensure single-use, sterility, or the like of injection system 10.

[0035] Referring now to Figs. 2-3, the injection system 10 may include or define a needle assembly operable and / or configured to provide selective dispersion of a substance from the container 12 to a patient. The needle assembly may include a needle 32 that is movable and / or selectively configurable into and out of fluid communication with the reservoir 14. In one example, the needle 32 may include a pointed and / or piercing proximal end 34, a pointed and / or piercing distal end 34, and a lumen 38 therethrough. The needle 32 may be movably positioned within at least a portion of the passage 22 of the port 16. In one example, the needle assembly may includea needle hub 40 coupled to the needle 33, with the needle hub 40 affixed to the needle 32 and movable axially along a longitudinal axis Al within the passage 22 in unison with the needle 32. The needle hub 40 may surround or circumscribe at least a portion of an exterior surface of the needle 33, and the needle hub 40 may engage, couple to, and / or otherwise contact a portion of an inner wall of the port 16 defining the passage 22.

[0036] The needle assembly may be operable and / or configured to provide selective fluid communication or fluid isolation between the lumen 38 of the needle 32 and the reservoir 14. In one example, the needle assembly may be operable and / or configured to axially move within the port 16 from a first position where the proximal end 34 of the needle 32 is within the second compartment 28 of the passage 22 and distal of the barrier 24 (as shown in Fig. 2), to a second position where the proximal end 34 of the needle 32 has pierced or otherwise moved through the barrier 24 such that the lumen 18 of the needle 32 is in fluid communication with the first compartment 26 and / or the reservoir 14 (as shown in Fig. 3).

[0037] In one example, the port 16 and / or the needle assembly may include or define one or more features and / or structures to provide an audible and / or tactile indication of the needle assembly moving axially in a proximal direction from the first position to the second position. The port 16 and / or the needle assembly may include or define one or more features and / or structures to prevent the needle assembly from moving distally from the second position back to the first position. For example, the port 16 may include or define a rib 42 extending around a circumference or perimeter of the passage 22 that provides resistance and / or restrictive engagement with a corresponding surface or feature of the needle hub 40. Additional and / or alternative mechanisms or structures may be implemented to provide the selective and / or resistive axial movement between the needle assembly and the port 16 described herein.

[0038] Now referring to Figs. 1-3 and Figs. 6-7, The injection system 10 may include a needle shield 44 operable and / or configured to enclose at least a portion of the needle 32 therein. The needle shield 44 may include or define a proximal end 46, a distal end 48, and a cavity 50 defined therein sized and shaped to accommodate at least a portion of the needle 32. The needle shield 44 may be releasably engageable with one or more of the port 16, the needle hub 40, the needle 32, and / or the container 12. In one example, the proximal end 46 of the needle shield may define or include an opening 52 to receive at least a portion of the needle 32 and / or the needle hub 40therethrough and into the cavity 50. The distal end 48 of the needle shield may be closed or sealed to provide sterility to the needle 32 until use and / or to prevent accidental needle sticks until use.

[0039] The injection system 10 may be configured and / or operable to enable detachment and / or removal of the needle shield 44 to expose the distal end 36 of the needle 32 for an initial and / or one-time use. The injection system 10 may also be configured and / or operable to enable reengagement and / or re-positioning of the needle shield 44 to enclose or cover distal end 36 of the needle 32 after use such that subsequent removal of the needle shield 44 and re-use of the needle 32 is prevented. As shown in Figs. 4-5, in one example, the port 16 may define one more channels 54 extending along a length of an interior surface thereof and along the length of the passage 22. In one example, the one or more channels 54 may include a plurality of channels radially spaced around a perimeter or circumference of the interior of the port 16. The one or more channels 54 may each extend in an axial direction substantially parallel to the axis Al. A proximal end 56 of each of the one or more channels 54 may be positioned within the second compartment 28 of the port 16 distal to the barrier 24, and a distal end 58 of each of the one or more channels 54 may each extend to and terminate at the distal end 20 of the port 16.

[0040] The port 16 may include or define one or more locking elements 60 laterally and / or radially adjacent to the proximal end 46 of each of the one or more channels 54. The locking elements 60 may be operable and / or configured to permit relative rotation between the port 16 and the needle shield 44 in a first direction, while preventing or obstructing relative rotation between the port 16 and the needle shield 44 in a second, opposite direction. In one example, the one or more locking elements may each define or include a ramped, sloped, and / or contoured surface that protrudes radially into the passage 22 beyond a radial depth or diameter of the channels 54. The port 16 may include or define one or more recesses 62 laterally and / or circumferential adjacent to each of the one or more channels locking elements 60. The one or more recesses 62 may be positioned on an opposite circumferential or lateral side of the locking elements 60 from the channel 54, such that each locking element 60 is disposed circumferentially or laterally between each channel 54 and each recess 62.

[0041] Referring to Figs. 6-7, the needle shield 44 may define or include one or more protrusions 64 configured and / or operable to engage or interact with one or more of the channels 54, locking elements 60, and / or recesses 62 to provide the rotational and axial movements described herein.In one example, the one or more protrusions 64 may each extend radially outward from an exterior surface of the needle shield 44 in proximity and / or adjacent to the proximal end 46 of the needle shield 44. The one or more protrusions 64 may include a plurality of protrusions radially spaced around an exterior perimeter and / or circumference of the needle shield 44. The one or more protrusions 64 may each include or define a cantilever joint and / or living hinge with respect to the body or exterior surface of the needle shield 44 such that at least a portion of each of the one or more protrusions 64 is radially movable and / or pivotable towards and away from the body or exterior surface of the needle shield 44.

[0042] Now referring to Figs. 8-10, in one example of use of the injection system 10, the reservoir 14 may be manufactured with and / or prefilled with a substance, such as a medicament or the like for injection. The needle assembly may be in the first position such that the reservoir 14 is isolated from the lumen 18 of the needle 32 by the barrier 24, valve 30, and or other sealing component. The needle shield 44 may be aligned with the port 16 such the each of the one or more protrusions 64 are positioned within or otherwise engaged with each of the channels 54 of the port. In this initial configuration, the needle shield 44 may be axially movable with respect to the container 12, port 16, and / or the components of the needle assembly. In a manufactured and / or pre-use state, the needle shield 44 may have a friction fit with one or more of the needle hub 40 and / or the port 16 to remain place until the injection system is ready for use.

[0043] To prepare the injection system 10 for use, the proximal end 34 of the needle 32 may be placed into fluid communication with the reservoir 14. This may be achieved, for example, by applying an axial force to the needle shield 44 in a proximal direction to move the needle 32 and / or the needle hub 40 in a proximal direction with respect to the port 16 such that the proximal end 34 of the needle 32 pierces the barrier 24.

[0044] Once the lumen 38 is in fluid communication with the reservoir 14, the needle shield may be axially moved in a distal direction such that the one or more protrusions exit the channels 54 at the distal end 20 of the port to thereby de-couple the needle shield 44 from the container 12 and the needle assembly, and expose the distal end 36 of the needle 32. The distal end 36 of the needle 32 may then be inserted into a patient, and the contents of the reservoir 14 transferred to and through the needle 32 to the patient.

[0045] Once the injection is complete, the needle shield 44 may be re-attached to the needle assembly and / or container 10 to prevent re-use and / or for safe disposal. For example, the one or more protrusions 64 may be radially aligned with the one or more channels 54 of the port 16 such that the needle shield 44 can move axially in a proximal direction with respect to the needle 32 and the container 12. The needle shield 44 may be moved proximally to enclose the distal end 36 of the needle within the cavity 50, and to position the one or more protrusions 64 at the proximal end 56 of each of the channels 54.

[0046] The needle shield 44 may then be rotated with respect to the port 16 from a first rotational position where the protrusions 64 are within the channels 54 of the port, to a second rotational position where each of the protrusions 64 has traversed each of the one or more locking elements 60 of the port 16, and each of the protrusions 64 resides at least partially within the one or more recesses 62 of the port. When rotating the needle shield 44 from the first rotational position to the second rotational position, each of the protrusion 64 may be radially depressed or moved inward towards the body or exterior surface of the needle shield 44 by one or more surfaces of the locking elements 60. Upon traversing the locking elements 60 and reaching the one or more recesses 62, the one or more protrusions 64 may resiliently extend radially outward to a natural or initial position.

[0047] In the first rotational position, as shown in Fig. 9, the needle shield 44 is axially movable with respect to the port 16 and / or the needle assembly. In the second rotational position, as shown in Fig. 10, the needle shield 44 is prevent from moving axially with respect to the port 16 and / or the needle assembly due to engagement of the protrusions 64 by the one or more recesses 62.

[0048] The one or more protrusions 64 may be configured and / or operable in conjunction with the one or more recesses 62 and / or the one or more locking elements 60 to prevent the needle shield 44 from transitioning from the second rotational position back to the first rotational position. For example, the one or more protrusions 64 may abut or contact a portion of the one or more recesses 62 and / or the one or more locking elements 60 to prevent or obstruct rotation between the needle shield 44 and the port 16.

[0049] With the needle shield 44 locked into the second rotational position, axial movement of the needle shield 44 is prevented and the needle shield 44 cannot be removed from the port 16,needle assembly, and / or container 12. The configuration and features described herein accordingly prevent re-use and ensure safe disposal of the injection system 10.

[0050] It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, the system components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, while certain embodiments or figures described herein may illustrate features not expressly indicated on other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily exclusive of each other and may be included in a variety of different combinations or configurations without departing from the scope and spirit of the disclosure. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the disclosure, which is limited only by the following claims.

Claims

WHAT IS CLAIMED IS:

1. An injection system, comprising: a container having a reservoir therein; a port coupled to the container and defining a passage therein; a needle at least partially disposed in the passage of the port; and a needle shield enclosing at least a portion of the needle therein, the needle shield rotatable from (i) a first rotational position permitting axial movement between the port and the needle shield, to (ii) a second rotational position preventing axial movement between the port and the needle shield.

2. The injection system of claim 1, wherein the needle is movable with respect to the port.

3. The injection system of claim 1, further comprising a needle hub surrounding a portion of the needle, wherein the needle hub is axially movable within the passage.

4. The injection system of claim 1, wherein the port includes a barrier therein separating the passage into a first compartment and a second compartment.

5. The injection system of claim 4, wherein the first compartment is in fluid communication with the reservoir.

6. The injection system of claim 5, wherein a proximal end of the needle is movable from (i) a first position in the second compartment to (ii) a second position in the first compartment and in fluid communication with the reservoir.

7. The injection system of claim 6, wherein the proximal end of the needle is configured to pierce the barrier in moving from the first position to the second position.

8. The injection system of claim 1, further comprising a valve positioned between the reservoir and the needle.

9. The injection system of claim 8, wherein the valve is a one-way valve permitting fluid flow from the reservoir to the needle, and preventing fluid flow form the needle to the reservoir.

10. The injection system of claim 1, wherein the port defines one or more channels on an interior surface thereof, and wherein the needle shield includes one or more protrusions on an exterior surface thereof, the one or more protrusion each movably positionable in the one or more channels.

11. The injection system of claim 10, wherein each of the one or more channels are axially-aligned along a length of the port.

12. The injection system of claim 10, wherein each of the one or more protrusions is movable with respect to the exterior surface of the needle shield.

13. The injection system of claim 10, further comprising a locking element circumferentially adjacent to each of the one or more channels, the locking element configured to permit rotation of the needle shield from the first rotational position to the second rotational position, and prevent rotation of the needle shield from the second rotational position to the first rotational position.

14. The injection system of claim 13, wherein the locking element includes at least one of a sloped surface, a ramped surface, or an arcuate surface.

15. An injection system, comprising: a container having a reservoir therein; a port coupled to the container and defining a passage therein, the port defining a channel extending axially along an interior surface thereof;a recess adjacent to the channel; a needle at least partially disposed in the passage of the port; and a needle shield enclosing at least a portion of the needle therein, the needle shield including a protrusion on an exterior surface thereof, the needle shield rotatable from (i) a first rotational position in which the protrusion is at least partially positioned within the channel to permit axial movement between the port and the needle shield, to (ii) a second rotational position in which the protrusion is at least partially positioned within the recess to prevent axial movement between the port and the needle shield.

16. The injection system of claim 15, further comprising a locking element positioned between the channel and the recess, wherein the protrusion traverses the locking element to move from the first rotational position to the second rotational position.

17. The injection system of claim 16, wherein the protrusion is movable with respect to the exterior surface of the needle shield, and wherein traversing the locking element moves the protrusion with respect to the exterior surface of the needle shield.

18. The injection system of claim 17, wherein the protrusion forms at least one of a cantilever joint or a living hinge with the exterior surface of the needle shield.

19. The injection system of claim 16, wherein the locking element is configured to permit rotation of the needle shield from the first rotational position to the second rotational position, and prevent rotation of the needle shield from the second rotational position to the first rotational position.

20. The injection system of claim 19, wherein the locking element includes at least one of a sloped surface, a ramped surface, or an arcuate surface.14

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