Valve assembly for drug delivery devices and other devices.

Abstract

A valve assembly for a drug delivery device includes a valve housing having a first side and a second side positioned opposite the first side, a cannula having a first end and a second end positioned opposite the first end, a piercing plate having a body and a piercing member extending from the body, with the body defining an elongated spiral member, and a valve cap connected to the valve housing and defining an internal space. The valve cap is configured to move from a pre-use position where the first end of the cannula and the piercing member of the piercing plate are received within the internal space to a use position where the piercing member of the piercing plate and the first end of the cannula extend out of the valve cap and the internal space.

Description

1 / 16 “VALVE ASSEMBLY FOR DRUG ADMINISTRATION DEVICES AND APPLIANCES” Cross-reference to related requests

[0001] This application claims priority to U.S. Provisional Application Serial No. 62 / 854,587, filed May 30, 2019, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION Field of invention

[0002] This disclosure relates generally to a drug delivery device and, in particular, to a set of valves for a drug delivery device. Description of the Related State of the Art

[0003] Various types of automatic injection or drug delivery devices have been developed to allow drug solutions and other liquid therapeutic preparations to be administered by untrained personnel or self-injected. In general, these devices include a reservoir that is pre-filled with the liquid therapeutic preparation and some type of automatic needle injection mechanism that can be activated by the user. When the volume of fluid or drug to be administered is generally below a certain volume, such as 1 mL, an autoinjector is typically used, which usually has an injection time of about 10 to 15 seconds. When the volume of fluid or drug to be administered is greater than 1 mL, the injection time generally becomes longer, resulting in difficulties for the patient to maintain contact between the device and the target area of ​​the patient's skin.Furthermore, as the volume of drug to be administered increases, it becomes desirable to increase the injection time. The traditional method for a drug to be slowly injected into a patient is to initiate an IV and inject the drug into the patient's body slowly. This procedure is typically performed in a hospital or outpatient setting. Petition 870260068848, dated 11 / 07 / 2026, page 18 / 39 2 / 16

[0004] Certain devices allow for self-injection at home and are capable of gradually injecting a liquid therapeutic preparation into a patient's skin. In some cases, these devices are small enough (both in height and overall size) to allow them to be "worn" by a patient while the liquid therapeutic preparation is being infused into the patient. These devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic preparation to flow out of a reservoir and into the injection needle. These devices also typically include a valve or flow control mechanism to cause the liquid therapeutic preparation to begin flowing at the appropriate time and a trigger mechanism to initiate the injection.The present invention seeks to solve the technical problem of providing controlled positioning and movement of the valve sleeve during the transition between the pre-use and use positions. To this end, it proposes a configuration in which the valve sleeve is positioned within the internal space defined by the valve cover, so that both components cooperate structurally and functionally during the actuation of the device. As a technical effect, a guided and coordinated movement of the valve sleeve is obtained, providing its protection and greater reliability of the mechanism. Unlike known solutions, such as that described in document US2017028132, the present invention establishes a spatial and functional relationship between the valve cover and the valve sleeve, and not merely the passive deformation of an external flexible cover. SUMMARY OF THE INVENTION

[0005] In one aspect or embodiment, a valve assembly for a drug delivery device includes a valve housing having a first side and a second side positioned opposite the first side, a cannula having a first end and a second end positioned opposite the first end, with the cannula defining a central passage, a piercing plate including a body and a Petition 870260068848, dated 11 / 07 / 2026, page 19 / 39 3 / 16 of the drilling member extends from the body, with the body formed by an elongated spiral member and the drilling member defining a central passage configured to receive the cannula and a valve cap connected to the valve housing and defining an internal space. The valve cap is configured to move from a pre-use position where the first end of the cannula and the drilling member of the drill plate are received within the internal space to a use position where the drilling member of the drill plate and the first end of the cannula extend out of the valve cap and the internal space.

[0006] The valve assembly may further include a valve sleeve that defines a cannula space; the valve sleeve is configured to move from a pre-use position where the first end of the cannula is received within the cannula space to a use position where the first end of the cannula extends out of the valve sleeve and the cannula space. The valve sleeve may be formed from an elastomeric material. The valve sleeve may include a first cylindrical portion having a convex tip, a second portion extending from the first portion, and a third frustoconical portion extending from the second portion. The valve cap may be formed from an elastomeric material. The valve cap may include a projection that extends radially inward, with the perforation plate engaged with the valve cap projection.The elongated spiral limb has a first end and a second end, spaced axially from the first end, the second end of the elongated spiral limb configured to move towards the first end of the elongated spiral limb. The elongated spiral limb may be frustoconical. The elongated spiral limb may include a first frustoconical portion and a second frustoconical portion, with the first frustoconical portion having a larger angle than the second frustoconical portion. The drilling limb may be connected to the second end of the elongated spiral limb. O. Petition 870260068848, dated 11 / 07 / 2026, page 20 / 39 The 4 / 16 drill member can be connected to the second end of the spiral elongated member by means of an adhesive or welding. The spiral elongated member can be formed from a metal wire. The metal wire can be formed from a shape memory alloy. The shape memory alloy can be Nitinol.

[0007] In another aspect or embodiment, a drug delivery device includes a housing, a cartridge received within the housing, the cartridge configured to receive a drug, an actuator assembly received within the housing and configured to engage the cartridge and dispense drug from the cartridge, a needle actuator assembly received within the housing, with the needle actuator assembly including a patient needle configured to pierce the skin of a patient, and a valve assembly including a valve housing having a first side and a second side positioned opposite the first side, a cannula having a first end and a second end positioned opposite the first end, with the cannula defining a central passage, a piercing plate comprising a body and a piercing member extending from the body,with the body formed from an elongated spiral member and the drilling member defining a central passage configured to receive the cannula and a valve cap connected to the valve housing and define an internal space. The valve cap is configured to move from a pre-use position where the first end of the cannula and the drilling member of the drill plate are received within the internal space to a use position where the drilling member of the drill plate and the first end of the cannula extend out of the valve cap and the internal space.

[0008] The drug delivery device may also include a valve sleeve that defines a cannula space; the valve sleeve is configured to move from a pre-use position where the first end of the cannula is received within the cannula space to Petition 870260068848, dated 11 / 07 / 2026, page 21 / 39 5 / 16 a position of use in which the first end of the cannula extends out of the valve sleeve and cannula space. The spiral elongated member may have a first end and a second end, spaced axially from the first end, with the second end of the spiral elongated member configured to move toward the first end of the spiral elongated member. The piercing member may be connected to the second end of the spiral elongated member. The piercing member may be connected to the second end of the spiral elongated member by means of an adhesive or welding. The spiral elongated member may be a shape memory alloy wire.

[0009] In another aspect or embodiment, a valve assembly for a drug delivery device includes a valve housing having a first side and a second side, positioned opposite the first side, a cannula having a first end and a second end, positioned opposite the first end, the cannula defining a central passage, a valve cap connected to the valve housing and defining an internal space, with the valve cap configured to move from a pre-use position, where the first end of the cannula is received within the internal space, to a use position where the first end of the cannula extends out of the valve cap and the internal space, and a valve sleeve defining a cannula space, with the valve sleeve configured to move from a pre-use position,where the first end of the cannula is received within the cannula space for a use position in which the first end of the cannula extends out of the valve sleeve and the cannula space.

[0010] The valve sleeve may be formed from an elastomeric material. The valve sleeve may include a first cylindrical portion having a convex tip, a second portion extending from the first portion, and a third frustoconical portion extending from the second portion. The second portion of the valve sleeve may include a section Petition 870260068848, dated 11 / 07 / 2026, page 22 / 39 6 / 16 frustoconical and a cylindrical section. The third portion of the valve sleeve may include at least one recessed portion configured to facilitate collapse and deformation of the valve sleeve. The valve sleeve may be formed from a rubber material. The valve cover may be formed from an elastomeric material. The valve assembly may further include a drilling plate comprising a body and a drilling member extending from the body, with the drilling member of the drilling plate received within the inner space of the valve cover when the valve cover is in the pre-use position, and with the drilling member of the drilling plate extending out of the valve cover and the inner space when the valve cover is in the use position.

[0011] In another aspect or embodiment, a drug delivery device includes a housing, a cartridge received within the housing, with the cartridge configured to receive a drug, an actuator assembly received within the housing and configured to engage the cartridge and dispense drug from the cartridge, a needle actuator assembly received within the housing, with the needle actuator assembly comprising a patient needle configured to pierce the skin of a patient, and a valve assembly as described in any of the above aspects or embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The aforementioned features and advantages, and other features of this disclosure, and the manner of obtaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of disclosure modalities taken together with the accompanying figures, wherein:

[0013] FIG. 1 is a perspective view of a drug delivery system according to an aspect or embodiment of the present application. Petition 870260068848, dated 11 / 07 / 2026, page 23 / 39 7 / 16

[0014] FIG. 2 is a cross-sectional perspective view of the drug delivery system of FIG. 1.

[0015] FIG. 3 is a front cross-sectional view of the drug delivery system of FIG. 1.

[0016] FIG. 4 is a top view of the drug delivery system of FIG. 1, showing an upper portion of the housing removed and the drug delivery system in a pre-use position.

[0017] FIG. 5 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a pre-use position.

[0018] FIG. 6 is a front cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a pre-use position.

[0019] FIG. 7 is a top view of the drug delivery system of FIG. 1, showing an upper portion of the housing removed and the drug delivery system in an initial actuation position.

[0020] FIG. 8 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in an initial actuation position.

[0021] FIG. 9 is a cross-sectional front view of the drug delivery system of FIG. 1, showing the drug delivery system in an initial actuation position.

[0022] FIG. 10 is a top view of the drug delivery system of FIG. 1, showing an upper portion of the housing removed and the drug delivery system in a position for use.

[0023] FIG. 11 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a position of use. Petition 870260068848, dated 11 / 07 / 2026, page 24 / 39 8 / 16

[0024] FIG. 12 is a front cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a position of use.

[0025] FIG. 13 is a top view of the drug delivery system of FIG. 1, showing an upper portion of the housing removed and the drug delivery system in a post-use position.

[0026] FIG. 14 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a post-use position.

[0027] FIG. 15A is a front cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a post-use position.

[0028] FIG. 15B is a cross-sectional front view of the drug delivery system of FIG. 1, showing a pad with the drug delivery system in a pre-use position.

[0029] FIG. 15C is a perspective cross-sectional view of the drug delivery system of FIG. 1, showing a pad with the drug delivery system in a pre-use position.

[0030] FIG. 15D is a perspective cross-sectional view of the drug delivery system of FIG. 1, showing a pad with the drug delivery system in a pre-use position.

[0031] FIG. 16 is a partial cross-sectional view of the drug delivery system of FIG. 1, showing a set of valves.

[0032] FIG. 17 is a cross-sectional perspective view of the valve assembly of the drug delivery system in FIG. 1.

[0033] FIG. 18 is a front cross-sectional view of the valve assembly of the drug delivery system of FIG. 1. Petition 870260068848, dated 11 / 07 / 2026, page 25 / 39 9 / 16

[0034] FIG. 19 is a perspective view of a drilling plate of the valve assembly of FIG. 17 according to an aspect or embodiment of the present application.

[0035] FIG. 20A is a cross-sectional view of the drilling plate of FIG. 19.

[0036] FIG. 20B is a partial cross-sectional view of the drilling plate of FIG. 19. DETAILED DESCRIPTION

[0037] The following description is provided to enable those skilled in the art to make and use the contemplated embodiments described 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 modifications, variations, equivalents and alternatives are intended to fall within the object and scope of the present invention.

[0038] For the purposes of the following description, the terms top, bottom, right, left, vertical, horizontal, upper, lower, side, longitudinal and their derivatives relate to the invention as they are oriented in the figures of the drawings. However, it should be understood that the invention may assume various alternative variations, except where expressly specified otherwise. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are simply exemplary embodiments of the invention. Therefore, specific dimensions and other physical characteristics related to the embodiments disclosed in this document should not be considered as limiting.

[0039] With reference to FIGS. 1-16, a drug delivery system 10 includes a drive assembly 12, a container 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, the container 14, the valve assembly 16, and the needle actuator assembly 18 are at least partially positioned within a Petition 870260068848, dated 11 / 07 / 2026, p. 26 / 39 10 / 16 housing 20. Housing 20 includes an upper portion 22 and a lower portion 24, although other suitable arrangements for housing 20 may be used. In one aspect, the drug delivery system 10 is an injector device configured to be worn or attached to a user and to administer a predetermined dose of a drug supplied within the container 14 by injection into the user. The system 10 can be used to deliver a bolus injection, wherein a drug is administered within a defined time period. The drug may be administered over a time period of up to 45 minutes, although other suitable injection amounts and durations may be used. A bolus administration or delivery may be performed with or without specific rate control. The system 10 may administer the drug at a fixed pressure to the user with the rate being variable.The general operation of system 10 is described below with reference to FIGS. 1-16.

[0040] With reference again to FIGS. 1-16, the system 10 is configured to operate by means of the engagement of an actuation button 26 by a user, which results in a needle 28 of the needle assembly 18 piercing the skin of a user, the actuation of the actuation assembly 12 to place the needle 28 in fluid communication with the container 14 and to expel fluid or medication from the container 14, and the withdrawal of the needle 28 after the injection of the medication is complete. The general operation of a drug delivery system is shown and described in International Publications Nos. 2013 / 155153 and 2014 / 179774, which are incorporated herein by reference in their entirety. The operation of the system 10 is also shown and described in US Publication No. 2017 / 0354788, which is incorporated herein by reference in its entirety.Housing 20 of system 10 includes an indicator window 30 for viewing an array of indicators 32 configured to provide a user with an indication of the status of system 10 and a container window 31 for viewing container 14. The indicator window 30 can be a magnifying glass to provide a clear view of... Petition 870260068848, dated 11 / 07 / 2026, page 27 / 39 11 / 16 indicator arrangement 32. The indicator arrangement 32 moves along with the needle actuator assembly 18 during the use of the system 10 to indicate a pre-use status, use status, and post-use status of the system 10. The indicator arrangement 32 provides visual cues regarding the status, although other suitable cues, such as an auditory or tactile one, may be provided as an alternative or additional indication.

[0041] With reference to FIGS. 4-6, during a pre-use position of system 10, the container 14 is spaced from the drive assembly 12 and the valve assembly 16 and the needle 28 is in a retracted position. During the initial actuation of system 10, as shown in FIGS. 7-9, the drive assembly 12 engages the container 14 to move the container 14 towards the valve assembly 16, which is configured to pierce a stop 36 of the container 14 and place the medication inside the container 14 into fluid communication with the needle 28 by means of a tube (not shown) or other suitable arrangement. The drive assembly 12 is configured to engage a stop 34 of the container 14, which will initially move the entire container 14 to engage with the valve assembly 16 due to the incompressibility of the fluid or medication inside the container 14.The initial actuation of system 10 is caused by a user engaging the actuation button 26, which releases the needle actuator assembly 18 and the drive assembly 12, as discussed in more detail below. During initial actuation, the needle 28 is still in the retracted position and about to move to the extended position to inject into the user of system 10.

[0042] During the use position of system 10, as shown in FIGS. 10-12, the needle 28 is in the extended position at least partially outside the housing 20 with the drive assembly 12 moving the stop 34 inside the container 14 to administer the medication from the container 14, through the needle 28 and to the user. In the use position, the valve assembly 16 has already pierced a closure 36 of the container 14 to place the container 14 in fluid communication with the needle 28, which also Petition 870260068848, dated 11 / 07 / 2026, pp. 28 / 39 12 / 16 allows the drive assembly 12 to move the stop 34 relative to the container 14 so that fluid can be dispensed from the container 14. In the post-use position of the system 10, shown in FIGS. 13-15, the needle 28 is in the retracted position and engaged with a pad 38 to seal the needle 28 and prevent any residual flow of fluid or medication from the container 14.

[0043] With reference to FIGS. 17-20B, as discussed above, the valve assembly 16 operates to facilitate fluid communication between the container 14 and the needle actuator assembly 18. The valve assembly 16 includes a valve housing 52, a cannula 54, a piercing plate 56, and a valve cap 58. As discussed below, the valve assembly 16 may also include a valve sleeve 60. The valve housing 52 has a first side 62 and a second side 64 positioned opposite the first side 62. The valve housing 52 may be formed integrally with the housing 20 of the system 10 or may be formed as a separate component. Cannula 54 has a first end 66 and a second end 68 positioned opposite the first end 66. Cannula 54 defines a central passage 70. The first end 66 of cannula 54 is sharpened and configured to pierce a septum of the container 14.The second end 68 of the cannula 54 is received and fixed to the valve housing 52. The valve housing 52 is in fluid communication with the needle actuator assembly 18 via tubing (not shown) to form a fluid flow path from the cannula 54 to the needle actuator assembly 18.

[0044] With reference again to FIGS. 17-20B, the drilling plate 56 includes a body 74 and a drilling member 76 extending from the body 74. The body 74 is formed from an elongated spiral member 78 with the drilling member 76 defining a central passage 80 configured to receive the cannula 54. The valve cap 58 is connected to the valve housing 52 and defines an internal space 82. The body 58 may be formed from an elastomeric material, although other suitable materials or combinations of materials may be used. The valve cap Petition 870260068848, dated 11 / 07 / 2026, pp. 29 / 39 13 / 16 is configured to move from a pre-use position where the first end 66 of the cannula 54 and the drilling member 76 of the drilling plate 56 are received within the internal space 82 to a use position where the drilling member 76 of the drilling plate 56 and the first end 66 of the cannula 54 extend out of the valve cap 58 and the internal space 82. The pre-use position of the valve cap 58 and the valve assembly 16 is shown in FIG. 18. Although not shown, the use position of the valve cap 58 and the valve assembly 16 will be similar to the use position of the valve assembly 16 shown in FIG. 16.In the use position, the perforation plate 56 is engaged with the valve housing 52 with the perforation member 76 perforating the valve shell 58 and a foil seal (not shown) in the container 14 and with the cannula 54 perforating a septum of the container 14 to provide fluid communication with the interior of the container 14 and the cannula 54. The valve cover 58 includes a projection 84 extending radially inward with the perforation plate 56 engaged with the projection 84. The projection 84 may be annular with the projection 84 engaging the body 74 of the perforation plate 56. In the pre-use position of the valve cover 58, as shown in FIG. 17, the perforation plate 56 is spaced from the valve housing 52 by means of the engagement of the projection 84 of the valve cover 58 with the perforation plate 56. During engagement with the cartridge 14, the valve cover 58 will collapse with the perforation plate 56 moving downwards towards the valve housing 52.

[0045] With reference to FIGS. 17 and 18, the valve sleeve 60 is positioned within the internal space 82 defined by the valve cap 58. The valve sleeve 60 defines a cannula space 86 and is configured to move from a pre-use position, where the first end 66 of the cannula 54 is received within the cannula space 86, to a use position where the first end 66 of the cannula 54 extends out of the valve sleeve 60 and the cannula space 86. The valve sleeve 60 may be formed from an elastomeric material, such as a rubber material, although Petition 870260068848, dated 11 / 07 / 2026, pp. 30 / 39 14 / 16 Other suitable materials or combinations of materials may also be used. In one aspect or embodiment, the valve sleeve 60 is a thin film of a non-rubber material. The valve sleeve 60 includes a first cylindrical portion 88 having a convex tip 90, a second portion 92 extending from the first portion 88, and a third frustoconical portion 94 extending from the second portion 92. The second portion 92 is frustoconical and cylindrical. The third portion 94 of the valve sleeve 60 may include one or more recessed portions 96 to facilitate the collapse and deformation of the valve sleeve 60. After engagement of the valve assembly 16 with the container 14, the valve sleeve 60 will retract with the first end 66 of the cannula 54 extending through the valve sleeve 60.

[0046] The valve sleeve 60 is configured to ensure that the cannula 54 and the flow path of the system 10 remain free from contamination during the operation of the system 10. During the operation of the system 10, as discussed above, the container 14 is moved to engage with the valve cap 58 to collapse the valve cap 58 with the piercing member 76 of the piercing plate 56 piercing the foil seal of the container 14 and the valve cap 58 to form the respective tabs (not shown). The valve sleeve 60 prevents any contamination present in the container 14 and valve cap 58 from being discharged or thrown from the container 14 or valve cap 58 onto or into the cannula 54. The valve sleeve 60 also protects the cannula 54 from contact with the tabs formed by the piercing element 76 and minimizes the surface area of ​​the container 14 lid 36 through which the cannula 54 must pass.The valve sleeve 60 is also configured to prevent contamination caused by the depressurization of the valve cap 58 when the valve cap 58 is compressed and subsequently pierced by the drilling member 76, preventing the settling of entrained contamination on the external and internal surfaces of the cannula 54.

[0047] With reference again to FIGS. 17-20B, as discussed above, the elongated spiral member 78 has a first Petition 870260068848, dated 11 / 07 / 2026, pages 31 / 39 15 / 16 end 102 and a second end 104 axially spaced from the first end 102 with the second end 104 of the spiral elongated member 78 configured to move towards the first end 102 of the spiral elongated member 78. The spiral elongated member 78 is frustoconical. More specifically, the spiral elongated member 78 includes a first frustoconical portion 106 and a second frustoconical portion 108. The first frustoconical portion 106 may have a larger angle than the second frustoconical portion 108. The drilling member 76 is connected to the second end 104 of the spiral elongated member 78. The drilling member 76 may be connected to the second end 104 of the spiral elongated member 78 by means of an adhesive or welding, although other suitable fastening arrangements may be used.The elongated spiral member 78 may be a metal wire that is wound around a mandrel to form the body shape 74 of the drill plate 56. In one aspect, the metal wire may be formed of a material that allows controlled collapse, preventing collapse upon itself. The metal wire may be deformed under low load conditions and then return to its original shape.

[0048] In one aspect, the metal wire can be formed from a shape-memory alloy, such as Nitinol, although other suitable materials or combinations of materials may be used. Shape-memory alloys are readily formed into a desired shape or configuration, with the shape, size, and dimensions being readily altered without significant tooling costs. The body 74 of the punch plate 56 acts as a spring and damper during the engagement of the cartridge 14 with the valve assembly 16 to more efficiently dissipate the force of the cartridge 14 in contact with the valve assembly 16. Due to the strength of the elongated spiral member 78, however, the punching functionality of the punch member 76 is not compromised. The strength and stiffness of the body 74 of the punch plate 56 can be easily adjusted by altering the number of Petition 870260068848, dated 11 / 07 / 2026, pages 32 / 39 16 / 16 revolutions of the spiral elongated member 78. The spiral elongated member 78 of the drill plate 56 includes approximately 22 revolutions or spirals, although any other suitable configurations may be used.

[0049] The elements of a disclosed aspect may be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the present invention.

[0050] Although this disclosure has been described as having exemplary designs, the present disclosure may be further modified within the purpose and scope of this disclosure. This application is therefore intended to cover any variations, uses or adaptations of the disclosure using its general principles. In addition, this application is intended to cover such deviations from the present disclosure as come within known or customary practice in the art to which this disclosure belongs and which fall within the limits of the appended claims. Petition 870260068848, dated 11 / 07 / 2026, pp. 33 / 39

Claims

1 / 5 CLAIMS 1. Valve assembly (16) for a drug delivery device (10), the valve assembly (16) comprises: a valve housing (52) having a first side (62) and a second side (64), positioned opposite the first side (62); a cannula (54) having a first end (66) and a second end (68), positioned opposite the first end (66), the cannula (54) defining a central passage (70); a piercing plate (56) comprising a body (74) and a piercing member (76) extending from the body (74), the body (74) comprising an elongated spiral member (78), the piercing member (76) defining a central passage (70) configured to receive the cannula (54);a valve cover (58) connected to the valve housing (52) and defining an internal space (82), the valve cover (58) is configured to move from a pre-use position where the first end (66) of the cannula (54) and the drilling member (76) of the drilling plate (56) are received within the internal space (82) to a use position where the drilling member (76) of the drilling plate (56) and the first end (66) of the cannula (54) extend out of the valve cover (58) and the internal space (82) and characterized in that a valve sleeve (60) defining a cannula space (86), wherein the valve sleeve (60) is positioned within the internal space (82) defined by the valve cover (58) and wherein the valve sleeve (60) and the valve cover (58) are configured to move cooperatively.

2. Valve assembly (16), according to claim 1, characterized in that, the valve sleeve (60) is configured to move from a pre-use position in which the first end (66) of the cannula (54) is received within the cannula space (86) to a use position in which the first end (66) of the cannula (54) extends out of the valve sleeve (60) and the cannula space (86).

3. Valve assembly (16), according to claim 2, characterized in that the valve sleeve (60) comprises a first cylindrical portion (88) having a convex tip (90), a second portion (92) extending from the first portion (88) and a third frustoconical portion (94) extending from the second portion (92).

4. Valve assembly (16), according to any one of claims 1 to 3, characterized in that the valve cover (58) includes a projection (84) extending radially inward, the perforation plate (56) engaged with the projection (84) of the valve cover (58).

5. Valve assembly (16), according to any one of claims 1 to 4, characterized in that the spiral elongated member (78) has a first end (102) and a second end (104), axially spaced from the first end (102), the second end (104) of the spiral elongated member (78) configured to move towards the first end (102) of the spiral elongated member (78).

6. Valve assembly (16), according to claim 5, characterized in that the elongated spiral member (78) is frustoconical.

7. Valve assembly (16), according to claim 6, characterized in that the elongated spiral member (78) includes a first frustoconical portion (106) and a second frustoconical portion (108), the first frustoconical portion (106) having a larger angle than the second frustoconical portion (108).

8. Valve assembly (16), according to any one of claims 5 to 7, characterized in that the drilling member (76) is connected to the second end (104) of the spiral elongated member (78). Petition 870260068848, dated 11 / 07 / 2026, page 14 / 39 3 / 5 9. Valve assembly (16), according to any one of claims 1 to 8, characterized in that the elongated spiral member (78) comprises a metal wire.

10. Valve assembly (16), according to claim 9, characterized in that the metal wire comprises a shape memory alloy.

11. Drug administration device (10), comprising: a housing (20); a cartridge (14) received within the housing (20), the cartridge (14) configured to receive a drug; an actuator assembly (12) received within the housing (20) and configured to engage the cartridge (14) and dispense drug from the cartridge (14); a needle actuator assembly (18) received within the housing (20), the needle actuator assembly (18) comprising a patient needle (28) configured to pierce the skin of a patient; and characterized in that it comprises a valve assembly (16), defined according to any one of claims 1-10.

12. Valve assembly (16) for a drug delivery device (10), the valve assembly (16) comprising: a valve housing (52) having a first side (62) and a second side (64), positioned opposite the first side (62); a cannula (54) having a first end (66) and a second end (68), positioned opposite the first end (66), the cannula (54) defining a central passage (70); a valve cap (58) connected to the valve housing (52) and defining an internal space (82), the valve cap (58) is configured to move from a pre-use position, where the first end (66) of the cannula (54) is received within the internal space (82) to a position of Petition 870260068848, dated 11 / 07 / 2026, page.15 / 39 4 / 5 use, wherein the first end (66) of the cannula (54) extends out of the valve cover (58) and the internal space (82); and characterized in that a valve sleeve (60) defines a cannula space (86), the valve sleeve (60) is configured to move from a pre-use position wherein the first end (66) of the cannula (54) is received within the cannula space (86) to a use position wherein the first end (66) of the cannula (54) extends out of the valve sleeve (60) and the cannula space (86), wherein the valve sleeve (60) is positioned within the internal space (82) defined by the valve cover (58) and wherein the valve sleeve (60) and the valve cover (58) are configured to move cooperatively.

13. Valve assembly (16), according to claim 12, characterized in that the valve sleeve (60) comprises an elastomeric material.

14. Valve assembly (16), according to claim 12 or claim 13, characterized in that the valve sleeve (60) comprises a first cylindrical portion (88) having a convex tip (90), a second portion (92) extending from the first portion (88) and a third frustoconical portion (94) extending from the second portion (92).

15. Valve assembly (16), according to claim 14, characterized in that the second portion (92) of the valve sleeve (60) comprises a frustoconical section and a cylindrical section.

16. Valve assembly (16), according to claim 14 or 15, characterized in that the third portion (94) of the valve sleeve (60) comprises at least one recessed portion (96) configured to facilitate a collapse and deformation of the valve sleeve (60).

17. Valve assembly (16), according to any one of claims 12 to 16, characterized in that the valve sleeve (60) comprises a rubber material. Petition 870260068848, dated 11 / 07 / 2026, p. 16 / 39 5 / 5 18. Valve assembly (16), according to any one of claims 12 to 17, characterized in that the valve cover (58) comprises an elastomeric material.

19. Valve assembly (16), according to any one of claims 12 to 18, characterized in that it further comprises a drilling plate (56) comprising a body (74) and a drilling member (76) extending from the body (74), wherein the drilling member (76) of the drilling plate (56) is received within the internal space (82) of the valve cover (58) when the valve cover (58) is in the pre-use position, and wherein the drilling member (76) of the drilling plate (56) extends out of the valve cover (58) and the internal space (82) when the valve cover (58) is in the use position.

20. Drug administration device (10), comprising: a housing (20); a cartridge (14) received within the housing (20), the cartridge (14) configured to receive a drug; an actuator assembly (12) received within the housing (20) and configured to engage the cartridge (14) and dispense drug from the cartridge (14); a needle actuator assembly (18) received within the housing (20), the needle actuator assembly (18) comprising a patient needle (28) configured to pierce the skin of a patient; and characterized in that it comprises a valve assembly (16), defined according to any one of claims 12-19. Petition 870260068848, dated 11 / 07 / 2026, p. 17 / 39

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