Safety syringe with rotating sleeve lock

Abstract

1. A safety-lock syringe assembly (20) comprising a barrel (22) and a sleeve (46), wherein the barrel (22) includes a distal end (23) and a proximal end (24), one or more lugs (30) extending outwardly from an outer surface (28) of the barrel (22), and a needle (36) extending from the distal end (23), the sleeve (46) having threads (48) that engage the one or more lugs (30) and including a sleeve lock mechanism (50), wherein the sleeve (46) is adapted to: threadably rotate in a first direction to a first position that exposes the needle (36); threadably rotate in a second direction to a second position that shields the needle (36); and threadably rotate in the second direction to a third position that engages the one or more lugs (30) with the sleeve lock mechanism (50) to irreversibly lock the sleeve (46) to the barrel (22).

Description

[Technical Field]

[0001] The present invention relates to medical devices, and more particularly to drug delivery devices that advance a stopper or plunger through a reservoir to dispense a drug from the reservoir. [Background technology]

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 U.S.C. §119(e) to U.S. patent application Ser. No. 18 / 072,448, filed Nov. 30, 2022, which is incorporated herein by reference in its entirety.

[0003] BACKGROUND OF THE INVENTION A syringe is a pump that has a barrel that can contain a fluid, a plunger that moves within the barrel, and a needle that draws the fluid from the reservoir and injects it into the body during axial movement of the plunger. Syringes are typically stored in a sterile environment before use to avoid the possibility of infection due to bacteria or viruses in the needle or barrel. Therefore, a common concern regarding syringes is the possibility of reuse. Reusing syringes is a common source of bacterial and viral infections, such as HIV. A safety syringe is a syringe that is designed to become inoperable after a single use to prevent reuse.

[0004] There are many types of safety syringes, and various designs are used to prevent reuse. Various factors increase the material and labor costs of existing safety pen needles, including, for example, the number of parts, molding equipment and operations, the use of springs, and secondary post-processing operations. Current patient-end shield assemblies include a spring subassembly and multiple moving parts. For example, many use a spring and sleeve that locks the needle into position within the sleeve and prevents it from extending from the sleeve when a mechanical action is performed to reposition the syringe. A disadvantage of safety syringes is that they generally have many parts, which requires more material to construct and is more complex to assemble. Additionally, many safety syringes have large barrels due to the sleeve and / or secondary shield. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, an improved safety syringe with reduced part count, complexity, and material requirements is desirable. [Means for solving the problem]

[0006] Accordingly, one aspect of the present invention provides a safety-lock syringe assembly including a barrel including a distal end and a proximal end, one or more lugs extending outwardly from an exterior surface of the barrel, a needle extending from the distal end, and a sleeve having threads engaging the one or more lugs, wherein the sleeve includes a sleeve-locking mechanism, wherein the sleeve threadably rotates in a first direction to a first position exposing the needle, the sleeve threadably rotates in a second direction to a second position shielding the needle, and the sleeve threadably rotates in the second direction to a third position engaging the one or more lugs with the sleeve-locking mechanism to irreversibly lock the shield to the barrel.

[0007] Advantageously, the safety-lock syringe assembly disclosed herein does not include a secondary shield and does not include a spring. Additionally, the safety-lock syringe assembly advantageously includes a rotational lock mechanism in which a threaded sleeve engages a lug on the barrel, and the rotational lock mechanism rotates to three positions: an injection position, a shielded position, and a locked position. Accordingly, the design of the safety-lock syringe assembly disclosed herein has fewer parts, is less complex, and requires less material than conventional safety syringes in the art.

[0008] Additional and / or other aspects and advantages of the invention will be set forth in the description that follows, or will be obvious from the description, or may be learned by practice of the invention.

[0009] The above and / or other aspects and advantages of embodiments of the present invention will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view of a safety-lock syringe assembly according to an exemplary embodiment of the present disclosure. [Figure 2] FIG. 2 is a perspective view of the barrel of FIG. 1. [Figure 3A] FIG. 2 is a partial side view of the barrel of FIG. 1. [Figure 3B] FIG. 2 is a partial side view of the barrel of FIG. 1. [Figure 4] FIG. 2 is a transparent perspective view of the sleeve of FIG. 1. [Figure 5] FIG. 2 is a cross-sectional view of the sleeve of FIG. 1. [Figure 6] 2 shows a cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in an initial position. [Figure 7] 2 is a partial cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in an initial position. [Figure 8]2 shows a cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in the injection position. [Figure 9] 2 is a partial cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in an injection position. [Figure 10] 2 illustrates a cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in the shielded position. [Figure 11] 2 shows a partial cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in the shielded position. [Figure 12] FIG. 2 is a cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in a locked position. [Figure 13] FIG. 2 is a partial cross-sectional view of the safety-lock syringe assembly of FIG. 1 with the sleeve in a locked position. DETAILED DESCRIPTION OF THE INVENTION

[0011] Reference will now be made in detail to the embodiments of the present invention, as illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. Reference to the drawings illustrates, but does not limit, the embodiments described herein.

[0012] The embodiments are not intended to be mutually exclusive, and thus features of one embodiment can be combined with other embodiments to the extent that they are not mutually inconsistent.

[0013] Those skilled in the art will understand that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of other embodiments and of being practiced or carried out in various ways. The words and terminology used herein are for purposes of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein means the inclusion of the items listed thereafter and equivalents thereof, as well as additional items.

[0014] Terms such as "first," "second," and "third" may be used herein to describe various elements, components, regions, layers, and / or sections. However, it will be further understood that these elements, components, regions, layers, and / or sections are not limited by these terms. These terms are used only to distinguish one element, component, region, layer, or section from another element, component, region, layer, or section.

[0015] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items. When preceding a list of elements, phrases such as "at least one" modify the list of elements as a whole and not each individual element in the list. Furthermore, terms such as "unit," "entity," "module," and the like, as used herein, refer to an element for performing at least one function or operation and may be implemented in hardware.

[0016] Unless otherwise limited, the terms "connected," "coupled," "mounted," and variations thereof are used broadly herein to encompass both direct and indirect connections, couplings, and attachments. Furthermore, the terms "connected," "coupled," and variations thereof are not limited to physical or mechanical connections or couplings. Furthermore, the use of terms such as "top," "bottom," "top," "front," "rear," "superior," "lower," "upper," "lower," "below," and other orientational descriptions is intended to facilitate the description of exemplary embodiments of the present invention and is not intended to limit the structures of exemplary embodiments of the present invention to a particular location or orientation. Those skilled in the art will understand that terms of degree, such as "substantially" or "approximately," refer to a reasonable range around and including a given value, as well as a range outside the given value, for example, to accommodate typical tolerances associated with the manufacture, assembly, and use of embodiments. When referring to a structure or characteristic, the term "substantially" includes the characteristic being a majority or the characteristic being the entirety.

[0017] Many of these exemplary embodiments will be apparent to those skilled in the art to which these exemplary embodiments pertain and may not be described in detail herein. In addition, one of ordinary skill in the art of pharmaceutical delivery devices will understand that the various features of the exemplary embodiments may be implemented individually or in any combination or subcombinations.

[0018] According to an exemplary embodiment, FIGS. 1-13 illustrate a safety-lock syringe needle assembly 20, also referred to as a safety rotation syringe. The safety-lock syringe needle assembly 20 includes a barrel 22 for containing a medium (e.g., an injectable medication such as insulin), the barrel 22 having a circular cross-section and extending along a longitudinal axis A. As shown in FIGS. 2, 3A, and 3B, the barrel 22 includes a distal end 23, a proximal end 24, and an outer surface 28. The barrel 22 further includes one or more lugs 30 extending radially from the outer surface 28 and opposite each other at the distal end 23. A barrel tip 32 extends axially from the distal end 23 of the barrel 22 and is in fluid communication with the barrel 22.

[0019] As shown in Figures 6-13, barrel cap 34 is in mating engagement with barrel tip 32. Needle 36 extends axially from barrel cap 34 and is in fluid communication with barrel tip 43 and barrel 22. Needle 36 allows media to be drawn into barrel 22 and / or expelled from barrel 22. Alternatively, as shown in Figure 3B, needle 36 extends directly from distal end 23 of barrel 22.

[0020] 1 and 4-13 show a sleeve 46 that is partially disposed around the distal end 23 of the barrel 22 and the barrel cap 34. The sleeve 46 is configured to prevent needle sticks and inadvertent injections when the sleeve 46 is in a shielded or locked position. The sleeve 46 includes one or more internal threads 48 disposed on a distal portion of the sleeve 46, the one or more internal threads threadably engaging one or more lugs 30. Advantageously, the engagement between the internal threads 48 and the one or more lugs 30 provides rotational movement of the sleeve between three positions: an injection position, a shielded position, and a locked position.

[0021] Advantageously, the sleeve 46 is threadably disposed on the proximal end of the internal threads 48 and includes at least one sleeve lock feature 50 centrally disposed on the sleeve 46. The sleeve lock feature 50 is configured to irreversibly engage the at least one lug 30 when pressed into contact with (engagement with) the at least one lug 30. The at least one sleeve lock feature 50 includes a sleeve recess 52 (i.e., a recess) defined in the sleeve 46 for receiving the at least one lug 30. The sleeve recess 52 includes a sleeve block surface 54 parallel to the longitudinal axis A and an inclined sleeve ramp surface 56.

[0022] Additionally, the sleeve lock mechanism 50 advantageously has threads with a different pitch / lead than the remaining internal threads 48 of the sleeve 46. Specifically, the sloped sleeve ramp surface 56 of the sleeve lock mechanism 50 has a different pitch / lead than the internal threads 48. The sloped sleeve ramp surface 56 provides a continuous path of travel between the internal threads 48 and the threads of the sleeve lock mechanism 50 for the lug 30 to enter the sleeve lock mechanism 50. However, the sleeve recess 52 and the sleeve lock surface 54 provide an inflection point in the path of travel. This inflection point maintains the path of travel for the lug 30 to enter the sleeve lock mechanism 50 but prevents the lug 30 from exiting the sleeve lock mechanism 50, preventing unlocking. Thus, the sleeve lock mechanism 50 advantageously provides a smooth transition for locking engagement of the sleeve 46 and prevents unlocking of the sleeve 46 when locked via the sleeve lock mechanism 50 by a user.

[0023] Advantageously, the safety-lock syringe assembly 20 does not include a secondary shield in addition to the sleeve 46. Additionally, advantageously, the safety-lock syringe assembly 20 does not include a spring. For example, no spring is used to move the sleeve 46 or actuate the sleeve lock mechanism 50. Instead, the sleeve 46 advantageously includes internal threads 48 and a sleeve lock mechanism 50 that engage with the lug 30 of the barrel 22 to expose, retract, and lock the injection needle. Thus, the design of the safety-lock syringe assembly 20 disclosed herein has the advantages of fewer parts, less complexity, and requiring less material than prior safety syringes in the art.

[0024] In an alternative embodiment, at least one thread is disposed on the exterior surface of the barrel, and at least one lug extends inwardly within the sleeve to provide threaded engagement with at least one thread (not shown). For example, the sleeve includes one or more lugs extending radially inward and opposite one another. The exterior surface of the barrel includes one or more external threads that each threadably engage one of the one or more lugs.

[0025] In this alternative embodiment, the barrel includes at least one barrel locking mechanism (similar to the sleeve locking mechanism described above) configured to irreversibly engage at least one lug (not shown) when pressed into contact with the at least one lug. The at least one barrel locking mechanism includes a barrel recess defined in the outer surface of the barrel for receiving the at least one lug. The barrel recess includes a barrel locking surface parallel to the longitudinal axis A and an inclined barrel ramp surface.

[0026] The operation of an exemplary embodiment of the safety-lock syringe needle assembly 20 is described below. Rotation of the sleeve 46 from an initial position (best shown in FIGS. 6 and 7 ) in a first rotational direction (e.g., clockwise) relative to the barrel 22 moves the sleeve 46 axially along the longitudinal axis A toward the proximal end 24 of the barrel 22, exposing the needle 36 in an injection position (best shown in FIGS. 8 and 9 ). Rotation of the sleeve 46 is accomplished via engagement of the internal threads 48 of the sleeve 46 with the lug 30 of the barrel 22. In the initial position, the needle 36 is shielded, sterile, and ready for immediate use. In the injection position, the needle 36 extends outside the sleeve 46 and is ready to expel or draw a medication from or into the barrel 22.

[0027] Rotation of the sleeve 46 from the injection position in a second rotational direction opposite the first rotational direction (e.g., counterclockwise) moves the sleeve 46 axially along the longitudinal axis back to the shielded position (best shown in FIGS. 10 and 11 ) where the needle 36 is no longer exposed. Rotation of the sleeve 46 is accomplished via engagement of the internal threads 48 of the sleeve 46 with the lug 30 of the barrel 22. The shielded position is similar to the initial position of the needle 36 where the needle 36 is retracted within the sleeve 46.

[0028] Further rotation of the sleeve 46 in the second rotational direction moves the sleeve 46 to the locked position (best shown in FIGS. 12 and 13) and forces the at least one sleeve lock mechanism 50 into contact with the at least one lug 30. As the sleeve 46 approaches the locked position, rotational resistance increases until the at least one sleeve lock mechanism 50 irreversibly "snap" into engagement with the at least one lug 30. This resistance helps prevent premature entry of the sleeve 46 into the locked position, eliminating waste.

[0029] The operation of the aforementioned alternative embodiment is similar to the exemplary embodiment of the safety-lock syringe needle assembly 20 disclosed herein. Specifically, rotation of the sleeve relative to the barrel from an initial position in a first rotational direction (e.g., clockwise) moves the sleeve axially along the longitudinal axis A toward the proximal end of the barrel, exposing the injection needle in the injection position. Rotation of the sleeve from the injection position in a second rotational direction opposite the first rotational direction (e.g., counterclockwise) moves the sleeve axially along the longitudinal axis back to the shielded position where the needle is no longer exposed. Further rotation of the sleeve in the second rotational direction moves the sleeve to the locked position, pressing the at least one barrel locking mechanism into contact with the at least one lug. As the sleeve approaches the locked position, rotational resistance increases until the at least one barrel locking mechanism irreversibly “snaps” into engagement with the at least one lug. This resistance helps prevent premature entry of the sleeve into the locked position, eliminating waste.

[0030] 1 and 6-13, safety lock syringe needle assembly 20 further includes a plunger assembly 58. Plunger assembly 58 includes a plunger 60 slidably disposed at least partially within barrel 22 and a stopper 62 secured to plunger 60 and in sealing engagement with barrel 22. Movement of plunger assembly 58 along longitudinal axis A alternately draws media into or expels media from barrel 22.

[0031] While only a few embodiments of the present invention have been shown and described, the present invention is not limited to the described embodiments. For example, different shapes and configurations of sleeve lock mechanisms may be used. Generally, for example, non-circular barrel cross-sections may be employed to optimize space utilization, and the dimensions of the device may be adjusted to provide maximum comfort to the user. Those skilled in the art will recognize that other modifications to the disclosed embodiments may be made without departing from the scope of the present invention. Furthermore, any of the embodiments, features, and / or elements disclosed herein may be combined with one another to form various additional combinations not specifically disclosed, so long as the combined embodiments, features, and / or elements are not mutually inconsistent. All such modifications and combinations are deemed to be within the scope of the present invention, as defined by the appended claims and their equivalents. No language in this specification or the claims is intended to invoke 35 U.S.C. § 112(f) unless the phrase "means for" is used.

Claims

1. A safety lock syringe assembly including a barrel and a sleeve, the barrel includes a distal end and a proximal end, one or more lugs extending outwardly from an outer surface of the barrel, and a needle extending from the distal end; the sleeve includes threads that engage the one or more lugs; the sleeve includes a sleeve lock mechanism; the sleeve is threadably rotated in a first direction to a first position exposing the needle; the sleeve is threadably rotated in a second direction to a second position in which the needle is shielded; The sleeve is threadably rotated in a second direction to a third position where one or more lugs contact a sleeve locking mechanism to irreversibly lock the sleeve relative to the barrel.

1. A safety lock syringe assembly comprising:

2. 10. The safety-lock syringe assembly of claim 1, wherein the lug is located at the distal end of the barrel.

3. 10. The safety-lock syringe assembly of claim 1, wherein the lug extends radially from the outer surface of the barrel.

4. a distal end of the barrel connected to and in fluid communication with the barrel tip; The barrel cap is fixed to the tip of the barrel.

2. The safety-lock syringe assembly of claim 1, wherein the needle is secured to the barrel cap and is in fluid communication with the barrel tip.

5. 2. The safety-lock syringe assembly of claim 1, wherein the sleeve threads are located at a distal portion of the sleeve.

6. 2. The safety-lock syringe assembly of claim 1, wherein the threads of the sleeve are female threads.

7. 2. The safety lock syringe assembly of claim 1, wherein the sleeve lock mechanism is located in a central portion of the sleeve.

8. 2. The safety lock syringe assembly of claim 1, wherein the sleeve lock mechanism includes a sleeve recess, a sleeve lock surface, and an inclined sleeve ramp surface.

9. 10. The safety-lock syringe assembly of claim 1, wherein the sleeve lock mechanism is located at the threaded proximal end of the sleeve.

10. 10. The safety lock syringe assembly of claim 9, wherein the sleeve lock mechanism includes threads having a different pitch than the thread pitch of the sleeve.

11. 10. The safety-lock syringe assembly of claim 1, wherein the first direction is opposite the second direction.

12. 2. The safety-lock syringe assembly of claim 1, further comprising a plunger assembly including a plunger slidably disposed within the barrel, and a stopper disposed at a distal end of the plunger for discharging the drug solution from the barrel.

13. 10. The safety-lock syringe assembly of claim 1, wherein movement between the first position, the second position, and the third position is accomplished without the use of a spring.

14. 10. The safety-lock syringe assembly of claim 1, wherein the sleeve moves axially as a result of rotational engagement between threads on the sleeve and one or more lugs on the barrel.

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