Method for piercing a seal of a container configured to be filled with a fluid

Abstract

To provide a method for puncturing a seal of a container configured to be filled with a fluid.SOLUTION: A method of piercing a seal of a container configured to be filled with a fluid, the seal and the container included in an injection device, the injection device further including a conduit, a translation mechanism, a collar coupled to the container, a lock, and a biasing member, the method including actuating the translation mechanism, translating the container within the injection device via the translation mechanism, deflecting at least a portion of the lock by engaging the collar with the lock to release the biasing member, and driving the conduit through the seal and into fluid communication with the fluid using a preload force of the biasing member.SELECTED DRAWING: Figure 17

Description

[Technical Field]

[0001] The present invention relates generally to delivery systems for administering medication, and more particularly, but not exclusively, to sterile puncture systems. [Background technology]

[0002] Currently, before a needle is introduced into a vial, primary container, or cartridge, the surface of the vial septum must be sterilized with an alcohol wipe to maintain a sterile environment. If the vial septum is not properly sterilized, the medication may become contaminated or contaminants may be delivered to the patient. Furthermore, such wiping is an extra step that is not practical when the container is inside a delivery device. Typically, wiping the surface of the vial septum also adds another step to the sterilization process. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent No. 3,605,744 [Patent Document 2] Japanese Patent Application Publication No. 64-005565 [Patent Document 3] Japanese Patent Application Publication No. 48-076390 [Patent Document 4] Japanese Patent Application Publication No. 08-052213 [Patent Document 5] Special Publication No. 07-501234 [Patent Document 6] Special Publication No. 2012-530582 Summary of the Invention [Problem to be solved by the invention]

[0004] Therefore, a sterile puncture system that ensures a sterile environment without the risk of contamination is desirable. [Means for solving the problem]

[0005] Aspects of the present disclosure provide a sterile vial puncture and sterilization system. The present disclosure also provides methods of assembling, using, and sterilizing the sterile vial puncture system. In one aspect, the present disclosure provides a method for forming a sterile primary container puncture mechanism. The method includes obtaining a pre-sterilized primary container having a first end, a first cavity, a second end with an opening communicating with the first cavity, a septum at least partially sealing the opening, and a product within the first cavity. The method further includes obtaining a dosing assembly including a first end portion of a hollow channel-forming member. The method also includes assembling the dosing assembly to the second end of the primary container in a non-sterile environment to form a second cavity around the first end portion of the channel-forming member and extending to the primary container. The method further includes terminally sterilizing the second cavity and the first end portion of the channel-forming member therein.

[0006] In some embodiments, the second cavity and the first end portion of the channel-forming member can be non-sterile prior to the terminally sterilizing step. In some embodiments, the terminally sterilizing step of the second cavity and the first end portion of the channel-forming member can include injecting a sterilant through the channel-forming member and thereby into the second cavity. In some such embodiments, the sterilant can be introduced into the channel-forming member via the second end portion of the channel-forming member that is disposed external to the injection assembly.

[0007] In some other such embodiments, the primary container can include a boot portion that defines a second cavity. In some such embodiments, the boot portion and the septum can be one piece. In some such embodiments, assembling the dosing assembly to the second end of the primary container can include inserting a channel-forming member through an opening in the boot portion that forms a sliding seal around the channel-forming member extending therethrough. In some such embodiments, the opening can be configured to vent positive pressure such that the injected sterilant flushes the channel-forming member and the atmosphere within the second cavity. In some such embodiments, the method can further include injecting an inert gas through the channel-forming member and thereby into the second cavity to flush the sterilant from the channel-forming member and the second cavity.

[0008] In some embodiments, the dosing assembly and primary container assembly can be configured such that axial translation of the primary container toward the first end portion of the channel-forming member drives the channel-forming member through the boot member and septum, thereby extending the channel-forming member through the second cavity and disposing the first end portion in fluid communication with the product. In some such embodiments, the primary container can be translated axially relative to the first end portion of the channel-forming member a distance to pierce the boot member and septum at the first end portion of the channel-forming member, thereby extending the channel-forming member through the second cavity and disposing the first end portion in fluid communication with the product. In some such embodiments, the primary container may translate axially relative to the first end portion of the conduit-forming member to an extent that actuation of the dosing assembly causes the dosing assembly to drive the conduit-forming member axially toward the primary container and pierce the first end portion of the conduit-forming member through the boot member and the septum, thereby extending the conduit-forming member through the second cavity and disposing the first end portion within the first cavity in fluid communication with the product. In some such embodiments, actuation of the dosing assembly may release preload energy in a resilient member of the dosing assembly to axially drive a driver member coupled to the conduit-forming member.

[0009] In some embodiments, the first end portion of the channel-forming member can be sterilized and covered by a cap member, and the injection assembly can include a transmission window in communication with the second cavity. In some such embodiments, terminally sterilizing the second cavity and the first end of the channel-forming member can include at least one of diffusing a sterilant through the transmission window and into the second cavity, and thereby into the first end portion, and directing ultraviolet light through the transmission window and into the second cavity.

[0010] In another aspect, the present disclosure provides a sterile puncture system including a sterile primary container and a dosing assembly assembled to the primary container, the dosing assembly including a channel-forming member. The sterile primary container includes a first end, a first cavity, a second end with an opening communicating with the first cavity, a septum at least partially sealing the opening, a product in the first cavity, and a boot portion forming a second cavity. The channel-forming member extends through the opening in the boot portion, such that the first end portion of the channel-forming member is disposed within the second cavity. The opening in the boot portion forms a sliding seal around the channel-forming member. Axial translation of the primary container toward the first end portion of the channel-forming member effects relative translation of the first end portion of the channel-forming member and the boot member and septum of the primary container, such that the channel-forming member extends through the second cavity and the first end portion is disposed within the first cavity in fluid communication with the product.

[0011] In some embodiments, the boot portion and the septum can be one piece, and the sliding seal can be configured to vent positive pressure in the second cavity. In some embodiments, axial translation of the primary container relative to the first end portion of the channel-forming member can pierce the boot member and the septum over the first end portion of the channel-forming member, thereby extending the channel-forming member through the second cavity and disposing the first end portion within the first cavity in fluid communication with the product.

[0012] In some embodiments, the second end portion of the channel-forming member can be disposed external to the dosing assembly within the sealed third cavity. In some embodiments, axial translation of the primary container relative to the first end portion of the channel-forming member can actuate the dosing assembly to drive the channel-forming member axially toward the primary container to pierce the first end portion of the channel-forming member through the boot member and the septum, thereby extending the channel-forming member through the second cavity and disposing the first end portion within the first cavity in fluid communication with the product. In some such embodiments, the dosing assembly can include a collar secured to the second end of the primary container, a driver retainer axially slidably coupled to the collar, a driver member axially slidably coupled to the driver retainer and secured to the channel-forming member, and a resilient member disposed between a portion of the driver retainer and the driver member. In some such embodiments, in a pre-actuation state of the system, the resilient member can apply a preload force to the driver member acting axially toward the second end of the primary container, and actuation of the injection assembly releases the preload force of the resilient member on the driver member, driving the flow path forming member axially toward the primary container and piercing the first end portion of the flow path forming member through the boot member and the septum, such that the flow path forming member extends through the second cavity and the first end portion is positioned within the first cavity in fluid communication with the product.

[0013] These and other objects, features and advantages of the present invention will become apparent from the following detailed description of various aspects of the invention taken in conjunction with the accompanying drawings. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description herein, serve to explain the principles of the disclosure. The drawings are merely for the purpose of illustrating preferred embodiments and are not to be construed as limiting the disclosure. It is emphasized that, according to industry practice, various features have not been drawn to scale. In fact, the dimensions of various features may be arbitrarily increased or decreased for clarity of discussion. The above and other objects, features, and advantages of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0014] [Figure 1] 1 is an exploded perspective view of a sterile vial puncturing system according to an embodiment of the present invention. FIG. [Figure 2] 2 is an exploded side view of the sterile vial puncturing system of FIG. 1 in accordance with an embodiment of the present invention. [Figure 3] 2 is an assembled perspective view of the sterile vial puncturing system of FIG. 1 with a transparent connector assembly according to an embodiment of the present invention. FIG. [Figure 4] 4 is a side view of the sterile vial puncturing system of FIG. 3 with a transparent connector assembly according to an embodiment of the present invention. [Figure 5] FIG. 4 is a perspective view of the assembled sterile vial puncture system of FIG. 3 with a transparent connector assembly, according to an embodiment of the present invention. [Figure 6] 4 is an enlarged perspective view of a portion of the sterile vial puncturing system of FIG. 3, according to an embodiment of the present invention. [Figure 7] 2 is an assembled perspective view of the sterile vial puncturing system of FIG. 1 with a transparent window seal, a support member, a collapsible member, a support ring, and an impact cushion, according to an embodiment of the present invention. FIG. [Figure 8] FIG. 8 is a side view of the sterile vial puncturing system of FIG. 7 according to an embodiment of the present invention. [Figure 9] FIG. 8 is a perspective view of the sterile vial puncturing system of FIG. 7 according to an embodiment of the present invention. [Figure 10]2 is an assembled perspective view of the sterile vial puncturing system of FIG. 1 according to an embodiment of the present invention. FIG. [Figure 11] FIG. 11 is a side view of the sterile vial puncturing system of FIG. 10 according to an embodiment of the present invention. [Figure 12] FIG. 11 is a perspective view of the sterile vial puncturing system of FIG. 10 according to an embodiment of the present invention. [Figure 13] 11 is an enlarged perspective view of a portion of the sterile vial puncturing system of FIG. 10 showing the collapsible member in a fully extended position, according to an embodiment of the present invention. [Figure 14] 11 is an enlarged perspective view of a portion of the sterile vial puncturing system of FIG. 10 showing the collapsible member in a collapsed position, according to an embodiment of the present invention. [Figure 15] 1 is an assembled cross-sectional view of a sterile vial puncturing system in a pre-activated state according to another aspect of the present invention. FIG. [Figure 16] 16 is an assembled cross-sectional view of the sterile vial puncturing system of FIG. 15 in an actuated state, with the channel-forming member sterilely coupled in fluid communication with the primary container, according to another embodiment of the present invention. FIG. [Figure 17] 1 is an assembled cross-sectional view of a sterile vial puncturing system in a pre-activated state according to another aspect of the present invention. [Figure 18] FIG. 10 is an assembled cross-sectional view of a sterile vial puncturing system in an activated state, with a channel-forming member sterilely coupled in fluid communication with a primary container, according to another aspect of the present invention. [Figure 19] 18 illustrates the introduction of sterilant into the channel-forming member of the sterile vial puncturing system of FIG. 17 after non-sterile assembly. [Figure 20] 18 illustrates sterilization of the end portion of the channel-forming member and the cavity of the boot member of the assembled sterile vial puncturing system of FIG. 17 via a sterilant. [Figure 21] 1 is an assembled cross-sectional view of a sterile vial puncturing system in a pre-activated state according to another aspect of the present invention. [Figure 22] 22 is an assembled cross-sectional view of the sterile vial puncturing system of FIG. 21 in an actuated state, with the channel-forming member aseptically coupled in fluid communication with the primary container, according to another embodiment of the present invention. [Figure 23]22 illustrates the sterile and non-sterile portions of the sterile vial puncturing system of FIG. 21, and possible post-assembly sterilization of the non-sterile portions. DETAILED DESCRIPTION OF THE INVENTION

[0015] Generally, disclosed herein are aseptic vial puncture and sterilization systems. Additionally, contemplated are methods for assembling, using, and sterilizing aseptic vial, primary container, and / or cartridge puncture systems. These systems and methods provide for puncturing a vial, primary container, or cartridge with a flow path mechanism (e.g., a needle) under sterile conditions without the need for alcohol swabbing and / or the need to assemble a drug container into a device and sterilize the puncture site for similar patient / provider interactions.

[0016] In this detailed description and the claims that follow, the terms proximal, distal, anterior, posterior, medial, lateral, superior, and inferior are defined according to their standard usage to refer to the device's relative placement on the body or to specific portions of a device according to directional reference terms. For example, "proximal" refers to the portion of the device closest to the attachment point, and "distal" refers to the portion of the device farthest from the attachment point. With respect to directional terms, "anterior" refers to a direction toward the front side of the device, "posterior" refers to a direction toward the back side of the device, "medial" refers to a direction toward the midline of the device, "lateral" refers to a direction toward the side of the device, i.e., away from the midline of the device, and "up" refers to a direction above another object or structure and "down" refers to a direction below it.

[0017] Referring to the drawings, in which like reference numerals are used to indicate like or similar components throughout the several views, and particularly to FIGS. 1-14, a sterile puncturing system 100 is shown. The terms “sterile puncturing system,” “sterile vial puncturing system,” and “sterile cartridge puncturing system” may be used interchangeably herein as they essentially refer to a sterile fluid channel-forming mechanism (e.g., needle) puncturing system or structure. The sterile puncturing system 100 includes a primary container, chamber, syringe, vial, or cartridge 102 having a first end 104 and a second end 106. The primary container or vial 102 may also include a cavity 108 that is open at the first end 104 and extends toward the second end 106. The second end 106 may include a neck 110, and a cap 112 engages the neck 110 to close the second end 106 of the primary container or vial 102. A septum 114 may be disposed between the primary container or vial 102 and the cap 112 to aid in closing the second end 106 of the primary container or vial 102 and to allow a needle 152 (e.g., a staked needle) to be inserted through the septum and into the primary container or vial 102. The cavity 108 of the primary container or vial 102 may be dimensioned to receive a piston 116 to close the first end 104 of the primary container or vial 102 when a medicament or fluid is within the cavity 108. The piston 116 may also aid in delivery of the medicament or fluid, as described further below. The sterile puncture system 100 may also include a seal 118. The seal 118 may be, for example, a ring shaped and sized to engage the cap 112 and surround the septum 114.

[0018] The sterile puncture system 100 may also include a connector assembly 120, as shown in FIGS. 1 and 2. The connector assembly 120 may include a connector body 122, a support member 140, a needle cover 150, a channel-forming member or needle 152 (e.g., a retainer needle), a collapsible member 160, a support ring 162, a sterile seal 164, and an impact cushion 170. The connector body 122 may include a base portion 124 and at least one coupling member 126. The base portion 124 may include an opening 128, a recess 130, and a window 132. The opening 128 may extend from a first end to a second end of the base portion 124 along a longitudinal axis of the connector body 122. The recess 130 may be disposed at the first end of the base portion 124. The at least one coupling member 126 may be, for example, a ring member (not shown) or at least two biasing legs 126. The at least two legs 126 may each include an engagement member 134 that engages with the cap 112 to secure the connector assembly 120 to the primary container or vial 102. The engagement members 134 may be, for example, protrusions extending inward from the at least two legs 126 toward the center of the connector body 122, and the engagement members 134 may be angled.

[0019] The connector assembly 120 can also include at least one sterilization indicator 136 and a window seal 138, as shown in FIGS. 1-7. The sterilization indicator 136 can, for example, inform a user when the connector assembly 120 is sterilized and ready for use. The sterilization indicator 136 can be positioned within the opening 128 and positioned so as to be visible through the window 132. The window seal 138 can, for example, be partially or completely transparent so as to allow a user to see into the window 132 and at least a portion of the opening 128 in the base portion 124. The window seal 138 can also close the window 132 to create a sterile environment for the channel-defining member 152.

[0020] The support member 140 can include a base portion 142 and a flange member 146 at a second end of the base portion 142. The flange member 146 can be generally perpendicular to the base portion 142. The support member 140 can also include an opening 144 extending from the first end to the second end. The flange member 146 can be sized to engage with the recess 130 in the base portion 124 of the connector body 122. The needle cover 150 can be sized, for example, to fit within the opening 144 in the support member 140. The needle cover 150 can also be shaped, for example, to match the shape of the opening 144, although other shapes that engage with the opening 144 are contemplated. The channel-forming member 152 can be partially inserted into the needle cover 150 prior to injection, as shown in FIGS. 3-9. The channel-forming member 152 may be dimensioned to extend entirely through the connector assembly 120, for example, to pass through the septum 114 for injecting a drug or fluid from the primary container or vial 102.

[0021] 1 and 2 , the collapsible member 160 may be, for example, cylindrical in shape and sized to engage with the support member 140. Alternatively, the collapsible member 160 may be, for example, a cylindrically shaped member with cylindrical accordion like ribs extending along at least a portion of the length of the collapsible member 160. The channel-forming member 152 may extend throughout the collapsible member 160. A support ring 162 may be coupled to the collapsible member 160. A sterile seal 164 may be disposed around the channel-forming member 152 where it extends from the collapsible member 160 to help maintain a sterile environment within the connector assembly 120. An impact cushion 170 may engage the support ring 162 and the collapsible member 160. If the primary container or vial 102 is moved forward while the channel-forming member 152 remains stationary, the impact cushion 170 limits the forward movement and engages the channel-forming member 152, collapsing the collapsible member 160 and causing the channel-forming member 152 to puncture the septum 114.

[0022] The sterile puncture system 100 may also include an injection assembly 180, as shown in FIGS. 1-5 and 7-12. The injection assembly 180 may include a tube 182, an injection member 184, and a needle cover 186. The tube 182 may be coupled to the channel-forming member 152 at a first end and to the injection member 184 at a second end. The needle cover 186 may engage with the injection member 184 at an end opposite the tube 182. The terms "needle cover," "cap," "cover," and "shield" may be used interchangeably herein to refer to structures used to maintain a sterile field around the injection member 184 and protect patients and medical professionals from accidental punctures by the injection member 184. The injection member 184 may be, for example, a needle, microneedle, cannula, etc. for hypodermic injection, or a tube, dispensing needle, etc. for topical application to the skin, a patch, etc.

[0023] The aseptic puncture system 100 can be assembled, for example, by inserting at least one sterilization indicator 136 into the opening 128 of the connector body 122. The window seal 138 can be secured over the window 132 of the connector body 122. The support member 140 can then be placed within the recess 130 of the connector body 122. The channel-forming member 152 can be coupled to the needle cover 150. The combined channel-forming member 152 and cover 150 can then be inserted into the opening 144 of the support member 140 and positioned in a desired location. The combined channel-forming member 152 and cover 150 can also be positioned within a collapsible member 160 that surrounds the support member 140. A support ring 162 can then be coupled to the collapsible member 160 to secure the combined channel-forming member 152 and cover 150 to the connector body 122. A sterile seal 164 may be placed where the channel-forming member 152 extends through the collapsible member 160 to prevent any contaminants from entering through the opening. A crash cushion 170 may then be placed over the support ring 162, the collapsible member 160, and the support member 140. The channel-forming member 152 may extend through the opening 172 in the crash cushion 170 and be coupled to the injection assembly 180. A first end of a tube 182 may then be coupled to the channel-forming member 152, and a second end of the tube 182 may be coupled to the injection member 184. The injection member 184 may have a cover 186 positioned on the end opposite the coupled tube 182. Once assembled, the connector assembly 120 and the injection assembly 180 may be sterilized. The connector assembly 120 may be sterilized, for example, by gamma sterilization, to form a sterile primary drug passageway.

[0024] After the connector assembly 120 is sterilized, the sealing ring 118 can be placed on the cap 112 of the primary container or vial 102, and at least one coupling member 126 can be inserted onto the cap 112 to secure the connector assembly 120 to the primary container or vial 102. A medication or fluid can be filled into the primary container or vial 102 for injection into a patient. The primary container or vial 102 and the needle environment below the window 132 must then be sterilized. To facilitate sterilization below the window seal 138, the window seal 138 can be made, for example, from Tyvek® or other similar material. Ethylene oxide (ETO) sterilization can then be used to sterilize the primary container or vial 102 and connector assembly 120. The ETO sterilization can penetrate the window seal 138 to sterilize the vial face, sealing ring 118, needle cover 150, and appropriate needle area 152 at the second end 106 of the primary container or vial 102.

[0025] A method of using the sterile puncturing system 100 may include, for example, viewing the sterilization indicator 136 to confirm that both gamma sterilization and ETO sterilization have occurred in the sterile puncturing system 100. When the indicator 136 reveals that sterilization is complete, the cover 186 may be removed from the injection member 184, and the injection member 184 may be coupled to the patient. The primary container or vial 102 may then be moved forward, and the impact cushion 170 may limit the forward movement of the channel-forming member 152. As the primary container or vial 102 moves, the collapsible member 160 may collapse, and the continued forward movement of the primary container or vial 102 may force the channel-forming member 152 to extend through the fixed cover 150, as shown in FIG. 14 . The collapsible member 160 may move, for example, a distance “d,” as shown in FIG. 13 . The distance “d” may, for example, be equal to the distance the channel-forming member 152 must be forced to puncture the septum 114. When the fixed channel-forming member 152 pierces the cover 150, the channel-forming member 152 pierces the septum 114 of the primary container or vial 102, as shown in Figure 14. When the channel-forming member 152 passes through the septum 114 and into the primary container or vial 102, a fluid connection is formed that allows the medication or fluid within the primary container or vial 102 to flow through the injection assembly 180 and into the patient's body.

[0026] 15 and 16 illustrate an alternative embodiment of a sterile piercing system generally designated by reference numeral 200. Sterile piercing system 200 is similar to sterile piercing system 100 described above and shown in FIGS. 1-14, and therefore similar reference numerals, preceded by a "2" rather than a "1," are used to indicate elements that function similarly. As shown in FIG. 15, primary container or vial 202 can contain a drug, medication, or other liquid or liquid-like substance as provided or in a loaded state. System 200 can be utilized with, or part of, a delivery device that activates the system to deliver the contents of primary container 202 into and through a flow channel or flow channel-forming member 252 (e.g., a stationary needle) and ultimately into the patient's body.

[0027] 15 , the system 200 can include a piston 216 slidably received within the cavity 208 of the primary container 202 behind the contents, such that the contents are disposed between the piston 216 and the second end 206 of the primary container 202 (as provided or loaded). The piston 216 and the interior of the primary container 202 can form a sterile or aseptic seal that prevents pathogens or other contaminants from entering between them and into the contents. The interior of the primary container, including the interior surface of the primary container 202, the contents, and the interior surface of the piston can be sterile or aseptic. The piston 216 can thereby maintain the sterility of the interior of the primary container 202. In some embodiments, the piston is made of rubber.

[0028] The system 200 can also include a boot or nipple portion 254 disposed at the second end 206 of the primary container 202, as shown in FIG. 15 . The boot 254 can include a base portion 255 disposed over (and / or at least partially under) the cap 212 (e.g., a crimp cap) at the opening at the second end 206 of the primary container 202, as described above. As also described above, the cap 212 can couple the septum 214 over and / or into the opening at the second end 206 of the primary container 202. Thus, the base portion 255 can overlie the septum 214 and the opening of the primary container 202. The assembly of at least the primary container 202, septum 214, cap 212, and boot 254 can be sterilized prior to assembly with other components of the system (as described further below), such that at least its interior or unexposed surfaces through which the channel-defining member 252 passes (except for the boot cavity 257, as described further below) are sterilized, as described further below.

[0029] 15, boot portion 254 can include a chamber portion 256 extending from base portion 255 in a direction at least generally away from piston 216. Chamber portion 256 defines a cavity or chamber 257, as shown in FIG. 15. Chamber portion 256 includes an opening 258 that communicates with cavity 257, as shown in FIG. 15. In some embodiments, boot portion 254 can be integral with septum 214 (i.e., a one-piece or one-piece construction). In some alternative embodiments (not shown), boot 254 can be provided on or initially assembled to channel-defining member 252 and is not directly placed on / within primary container 202 and / or is not integral with septum 214. For example, as described further herein with respect to other embodiments, boot 254 can comprise a subassembly that is sterilized separately from primary container 202 and to which primary container 202 is assembled (optionally non-destructively sterilized after assembly) in a non-sterile environment.

[0030] 15 , a portion of the channel-forming member 252, such as a needle or tube, can extend through an opening 258 in the chamber portion 256 into the cavity 257 of the boot 254, but not through the base portion 255. A first tip or first end portion of the channel-forming member 252 can thereby be disposed within the cavity 257. The opening 258 can be preformed or can be formed by the passage of the channel-forming member 252 through the chamber portion 256. The opening 258 in the chamber portion 256 can form a sterile sliding seal around the channel-forming member 252, thereby preventing pathogens or other contaminants from entering therebetween and into the cavity 257, and allowing the channel-forming member 252 to translate axially relative to the boot portion 254 without disrupting the sterile seal therebetween. The cavity 257 can be sterile or aseptic, such that the interior surface of the cavity 257 and the first end portion of the channel-forming member 252 disposed therein are sterile. As will be further described below with respect to another embodiment, cavity 257 may not be initially sterile and can be sterilized after the first end portion of channel-forming member 252 is inserted into cavity 257 through opening 258. In an alternative embodiment, a convoluted flexible (e.g., rubber) bellows or bladder member, rather than boot 254, may form cavity 257 and allow axial translation of primary container 202 relative to the first end portion of channel-forming member 252 (or vice versa). The flexible member may also seal or form cavity 254 around the first end portion of channel-forming member 252 after sterilization thereof.

[0031] The channel-forming member 252 may be positionally fixed relative to the primary container 202 and components secured thereto. In other words, the channel-forming member 252 may be substantially fixed in space (such as fixed to a device with which the system is utilized), and the primary container 202 and components secured thereto may be movable or translatable relative to the channel-forming member 252 (such as movable or translatable relative to a device with which the system is utilized). For example, the channel-forming member 252 may be fixed to a larger device or system to which the primary container 202 is movably attached.

[0032] As shown in FIG. 15 , the piston 216 can be coupled to a translation mechanism 266 configured to axially translate the piston 216 relative to the primary container 202 (and components coupled thereto) toward the second end 206. The translation mechanism can be any mechanism effective to selectively axially translate the piston 216 relative to the primary container 202 (and components coupled thereto) toward the second end 206. As shown in FIG. 16 , axial movement of the piston 216 relative to the primary container 202 (and components secured thereto) causes the piston 216 to act on the contents (e.g., a drug, agent). Due to the design of the system 200 and / or friction of the piston 216 with the primary container 202, the primary container 202 moves axially more easily than the piston 216, thereby allowing or dictating that the primary container 202 be translated axially first via the translation mechanism 266. By way of example, axial movement of piston 216 may compress the contents of primary container 202, thereby transmitting an axial force to second end 206 of the primary container to attempt to axially translate primary container 202 and components secured thereto.

[0033] 16 , the translation mechanism 266 can axially translate the piston 216, and thereby the primary container 202 and components secured thereto, to the extent that the first end portion of the stationary or fixed channel-defining member 252 punctures, penetrates, or extends through the boot 254, the septum 214, and the cavity 208 of the primary container 202, thereby providing fluid communication with the contents of the primary container 202. In other words, the translation mechanism 266 can axially translate the piston 216, and thereby the primary container 202 and components secured thereto, to the extent that the base portion 255 of the boot 254 pierces the first end portion of the stationary or fixed channel-defining member 252, thereby providing fluid communication with the contents of the channel-defining member 252, extending through the septum 214 and into the cavity 208 of the primary container 202, thereby providing fluid communication with the contents thereof. In some embodiments, the system 200 can be configured such that, after actuation, no portion of the channel-forming member 252 extends into the cavity 208 of the primary container 202 other than the portion that was disposed within the sterile cavity 257 of the chamber portion 256 prior to actuation. As a result, axial movement of the primary container 202 via the piston 216 and axial translation mechanism 266 achieves a sterile coupling of the channel-forming member 252 with the cavity 208 (and contents therein) of the primary container 202. This ensures that the primary container 202 remains intact until use, provides greater storage stability for the contents within the cavity 208 of the primary container 202, and prevents leakage from the channel-forming member 252 prior to use.

[0034] Once the first end portion of the channel-forming member 252 extends into the cavity 208 of the primary container 202, thereby in fluid communication with its contents, further axial translation of the primary container 202 and components secured thereto via the translation mechanism 266 may be prevented. For example, the device or system in which the system 200 is installed may include a stop configured to allow only limited axial translation of the primary container 202. Thus, as shown in FIG. 16 , once the first end portion of the channel-forming member 252 extends into the cavity 208 of the primary container 202, thereby in fluid communication with its contents, further axial translation of the piston 216 via the translation mechanism 266 forces the contents within the primary container 202 through the channel formed by the channel-forming member 252. As discussed above, the channel-forming member 252 may be configured to ultimately deliver its contents to a patient, for example, as a subcutaneous injection or topical application.

[0035] The translation mechanism 266 can achieve or effect axial movement of the piston 216, thereby axially translating the primary container 202 and pumping the contents of the cavity 208 through the channel-defining member 252, via any manner or method. For example, the exemplary embodiment shown in FIGS. 15 and 16 includes a lead screw mechanism coupled to the backside of the piston 216 that extends axially upon relative rotation about an axis. The base of the lead screw mechanism can be positionally fixed or stationary to achieve movement of the piston 216. In another exemplary embodiment (not shown), the translation mechanism 266 can include a manually actuable surface or member that is manually operated by a user to axially translate the piston 216. For example, the system 200 can include a cartridge or plunger coupled to the backside of the piston 216 that is manually actuated to axially translate the piston 216. In another exemplary embodiment (not shown), the translation mechanism 266 can include a user-actuated or triggered pneumatic or hydraulic drive member that provides axial translation of the primary container 202 and the piston 216 relative to the primary container 202. The pneumatic or hydraulic drive member can utilize air or hydraulic pressure to axially translate the drive member. The drive member can be in the form of, for example, an expansion bellows, an expansion bladder, an expansion diaphragm, or a sliding seal or piston. The drive member can enable or provide axial translation of the primary container 202, and direct air or hydraulic pressure can axially translate the piston 216.

[0036] Figures 17-20 illustrate an alternative exemplary embodiment of a sterile puncturing system generally designated by reference numeral 300. Exemplary sterile puncturing system 300 is similar to exemplary sterile puncturing system 100 described above and shown in Figures 1-14, and exemplary sterile puncturing system 200 described above and shown in Figures 15 and 16, and therefore similar reference numerals, preceded by the numeral "3" as opposed to the numerals "1" or "2," are used to indicate similarly functioning elements. As shown in Figure 17, the configuration of primary container 302, contents therein, piston 316, translation mechanism 366, cap 312, septum 314, and boot 354 of sterile puncturing system 300 may be substantially the same as the configuration of sterile puncturing system 200 described above and shown in Figures 15 and 16. The sterile piercing system 300 of FIGS. 17 and 18 may differ from the sterile piercing system 200 of FIGS. 15 and 16 in that the channel-forming member 352 is sterilely coupled to the cavity of the primary container 302 .

[0037] As shown in Figures 17 and 18, rather than piercing the base portion 355 of the boot 354 and the septum 314 into and through the end portion of the flow path forming member 353 (i.e., translating the primary container 302 relative to the stationary or fixed flow path forming member 353) as described above with respect to the sterile puncturing system of Figures 15 and 16, the sterile puncturing system 300 drives the end portion of the flow path forming member 353 into and through the base portion 355 of the boot 354 and the septum 314 into the cavity 308 of the primary container 302, thereby placing it in fluid communication with the contents therein (i.e., translating the flow path forming member 353 relative to the fixed primary container 302).

[0038] As shown in FIGS. 17 and 18 , the sterile puncture system 300 includes a collar 390 coupled or secured to the second end 306 of the primary container 302. The collar 390 may include a plurality of circumferentially spaced fingers 392 that engage and surround the neck region 310 of the primary container 302. In this manner, the collar may be secured to the second end 306 of the primary container 302. However, the collar 390 may be coupled to the second end 306 of the primary container 302 in other ways. The collar 390 may include an axially extending wall portion 391 that extends at least partially around the neck region 310, the opening in the second end 306, the cap 312, the septum 314, and / or the boot 354. The wall portion 391 of the collar 390 may be disposed radially or laterally outward of the neck region 310 and / or extend axially through the neck region 310, the cap 312, and the septum 314. The wall portion 391 of the collar 390 may also extend axially through at least a portion of the boot 354, such as through the base portion 355 and partially through the chamber portion 356, as shown in Figures 17 and 18.

[0039] In a pre-actuated state of system 300, as shown in FIG. 17, at least one engagement portion or distal axial edge 393 of collar 390 can engage with at least one corresponding radially or laterally inwardly extending cam, latch, or actuation portion 394 of driver retainer member 395. Retainer member 395 can be axially slidably or translatably coupled to collar 390. In the pre-actuated state or configuration shown in FIG. 17, at least a portion of cam or actuation portion 394 of retainer member 395 is disposed axially directly rearward of a retaining portion 399 of driver member 398, which is axially slidably or translatably coupled within retainer member 395. As shown in FIG. 17, flow-path engaging portion 391 of driver member 398 can extend axially into and through an axial end cap portion 396 of retainer member 395 and into an interior portion of retainer member 395, and retaining portion 399 of driver member 398 can extend from flow-path engaging portion 391. In some embodiments, the flow path engaging portion 391 of the driver member 398 can be substantially cylindrical, and the retaining portion 399 of the driver member 398 can be a flange extending around the axial end of the flow path engaging portion 391, as shown in FIG. 17.

[0040] 17, in the pre-actuated state of system 300, a resiliently deformable biasing or resilient member 397 can be axially disposed between cap portion 396 of retainer member 395 and retention portion 399 of driver member 398. Biasing member 397 can thereby apply an axial preload force acting in a direction toward primary container 302 to driver member 398 in the pre-actuated state of system 300. As discussed below with reference to FIG. 18, biasing member 397 can be any member effective to apply an axial preload force in the pre-actuated state and subsequently release such preload force upon actuation. In some embodiments, biasing member 397 can be a spring.

[0041] The channel-forming member 352 can be fixed or coupled to the driver member 398, such that the channel-forming member 352 slides or translates axially with the driver member 398. As described above, in the pre-activated state of the system 300, the first end portion of the channel-forming member 352 can be positioned within the sterile cavity 357 of the chamber portion 356 of the boot 354, but without passing through the base portion 355 of the boot 354, the septum 314, and / or into the primary container cavity 308. As shown in FIG. 17 , in the pre-activated state, the first end portion of the channel-forming member 352 can be axially spaced from the base portion 355 of the boot 354.

[0042] As will be further described below, the assembly of driver member 398, flow path defining member 352, biasing member 397, and driver retainer member 395 may be axially fixed during a pre-actuation state of system 300 and during actuation prior to release of driver 398. In other words, driver member 398, flow path defining member 352, biasing member 397, and driver retainer member 395 may be substantially axially fixed in space (e.g., fixed to a device with which system 300 is utilized), and primary container 302 and components secured thereto may be axially movable or translatable relative to driver member 398, flow path defining member 352, biasing member 397, and driver retainer member 395 (e.g., movable or translatable relative to a device with which the system is utilized) during a pre-actuation state of system 300 and during actuation prior to release of driver 398. For example, the driver member 398, flow path forming member 352, biasing member 397 and driver retainer member 395 may be axially secured to a larger device or system to which the primary container 302 (and components secured thereto) are movably mounted.

[0043] When system 300 is operated as shown in FIG. 18 (and compared to FIG. 17 ), translation mechanism 366 can be actuated or operated (as described above) to translate piston 316 axially toward second end 306 of primary container 302. As described above, such axial movement of piston 316 within cavity 308 of primary container 302 acts to compress contents within cavity 308 and ultimately axially translate primary container 302 and the components secured thereto in an axial direction extending from first end 304 to second end 306. During operation of system 300 as shown in FIG. 18 , translation mechanism 366 can axially translate primary container 302 to an extent that at least one engagement portion 393 of collar 390 engages at least one cam or actuation portion 394 of driver retainer member 395, deflecting or translating it radially or laterally out of the axial rear of retention portion 399 of driver member 398. In this manner, the retaining portion 399 of the driver member 398 may overcome at least one cam or actuation portion 394 of the driver retainer member 395, allowing the preload force of the biasing member 397 to axially translate the driver 398 and the flow path forming member 352 secured thereto toward the second end 306 of the primary container 302.

[0044] It should be noted that system 300 may be configured such that axial translation of primary container 302 and collar 390, which releases at least one cam or actuation portion 394, does not act to cause the first end portion of channel-forming member 352 to puncture and / or extend through base portion 355 of boot 354 and / or septum 314. For example, in a pre-actuated state, the first end portion of channel-forming member 352 may be sufficiently axially spaced from base portion 355 of boot 354 and / or septum 314 such that axial translation of primary container 302 and collar 390, which releases at least one cam or actuation portion 394, does not act to cause the first end portion of channel-forming member 352 to puncture and / or extend through base portion 355 of boot 354 and / or septum 314.

[0045] 18 , axial translation of the driver 398 and channel-forming member 352 toward the second end 306 of the primary container 302 causes the first end portion of the channel-forming member 352 to puncture and penetrate or extend through the base portion 355 of the boot 354, the septum 314, and the cavity 308 of the primary container 302, thereby providing fluid communication with the contents of the primary container 302. In other words, the translation mechanism 366 can axially translate the piston 316 and, thereby, the primary container 302 and components secured thereto, such as the collar 390, to the extent that the driver 398 is “released” to pierce the boot 354 and the septum, thereby causing the channel-forming member 352 to extend into the cavity 308 of the primary container 302, thereby providing fluid communication with its contents. In some configurations, the system 300 can be configured such that, during actuation, only the portion of the channel-forming member 352 that was disposed within the sterile cavity 357 of the chamber portion 356 prior to actuation extends into the cavity 308 of the primary container 302. As a result, axial movement of the driver 398 and the channel-forming member 352 achieves sterile coupling of the channel-forming member 352 with the cavity 308 (and contents therein) of the primary container 302. This allows the primary container 302 to remain intact until use, providing greater storage stability for the contents within the cavity 308 of the primary container 302 and preventing leakage from the channel-forming member 352 prior to use.

[0046] The biasing member 397 may be configured to cause the channel-forming member 352 to pierce the boot 354 and / or septum 314 at a substantially high rate, such as at least about 10 mm / sec. In some embodiments, the biasing member 397 may be configured to cause the channel-forming member 352 to pierce the boot 354 and / or septum 314 at about 40 mm / sec. The relatively rapid puncture of the boot 354 and / or septum 314 via the biasing member 397 may advantageously prevent leakage of the contents of the cavity 308, which is under pressure via the piston 316, while the channel-forming member 352 is partially penetrated.

[0047] Once the at least one cam 394 is released and the first end portion of the channel-forming member 352 extends into the cavity 308 of the primary container 302, thereby in fluid communication with its contents, further axial translation of the primary container 302 and the components secured thereto via the translation mechanism 366 may be prevented. Thus, as shown in FIG. 17 , further axial translation of the piston 316 via the translation mechanism 366 after the first end portion of the channel-forming member 352 extends into the cavity 308 of the primary container 302, thereby in fluid communication with its contents, forces the contents through the channel formed by the channel-forming member 352. As discussed above, the channel-forming member 352 may be configured to ultimately deliver the contents to a patient, for example, as a subcutaneous injection or topical application.

[0048] 19 and 20 illustrate systems and methods for sterilizing the cavity 357 of the chamber portion 356 of the boot 354 and the first end or first tip portion of the channel-forming member 352. In some embodiments, the boot 354 can initially be non-sterilely coupled to the primary container 302. Similarly, when the system 300 is initially assembled, the first end portion of the channel-forming member 352 can be non-sterilely inserted into the cavity 357, for example, as shown in FIG. 17 . In such a configuration of the system 300, a sterilant, such as a gaseous sterilant, can be injected through the passages of the channel-forming member 352 from the first end portion into the cavity 357. In this manner, the passages of the channel-forming member 352, the outer surface of the first end portion of the channel-forming member 352 within the cavity 357, and the cavity 357 itself can be sterilized in the assembled state of the system 300. The sterilant may be any sterilant effective to sterilize channel-forming member 352, the outer surface of the first end portion of channel-forming member 352 within cavity 357, and cavity 357. For example, the sterilant may be ethylene oxide gas (EtO), vaporized hydrogen peroxide (VHP), nitrogen dioxide (NO), chlorine dioxide (ClO), or a combination thereof.

[0049] As shown in FIG. 19 , the sterilant can be introduced into the channel-forming member 352 through a second end portion thereof. The second end portion of the channel-forming member 352 can extend into a seal 321 that defines a cavity 323. The seal 321 can be disposed adjacent to an outer wall or exterior portion 327 of the system 300 or a system or device in which the system 300 is utilized or installed. Thus, as shown in FIG. 19 , a needle or other insertion member 325 can be utilized to extend through the outer wall 327 and the seal 321 into the cavity 323. The seal 321 can be substantially airtight except for the channel-forming member 352 and the insert member 325. Thus, as shown by the arrows in FIG. 19 , the sterilant can be introduced into the cavity 323 through the insert member 325 and then into the channel-forming member 352. The seal 321 can be configured to seal any openings provided by the insert member 325 and / or the channel-forming member 352 after the sterilant has been introduced.

[0050] As shown in FIG. 20 , sterilant can flow through the channel-forming member 352 from the first end to the second end and into the cavity 357 of the chamber portion 256 of the boot 354. As shown by the arrows in FIG. 20 , the chamber portion 356 can be configured to vent positive pressure around the first end portion of the channel-forming member 352 through openings 358 to allow sterilant to flow from the atmosphere inside the channel-forming member 352 into the cavity 357. As a result, the flow path formed by the channel-forming member 352, the outer surface of the first portion of the channel-forming member 352 within the cavity 357, and the cavity 357 itself can be sterilized after the system 300 is assembled. After sterilization, the sterilant within the channel-forming member 352 and cavity 357 can be flushed out with an inert gas (e.g., nitrogen) without damaging the contents of the primary container 302, just as when a sterilant is introduced and utilized to flush and sterilize a non-sterile atmosphere within the channel-forming member 352 and cavity 357.

[0051] Figures 21-23 illustrate an alternative exemplary embodiment of a sterile puncturing system generally designated by reference numeral 400. Exemplary sterile puncturing system 400 is similar to exemplary sterile puncturing system 100 described above and shown in Figures 1-14, exemplary sterile puncturing system 200 described above and shown in Figures 15 and 16, and exemplary sterile puncturing system 300 described above and shown in Figures 17-20, and therefore similar reference numerals, preceded by the numeral "4" as opposed to the numerals "1," "2," or "3," are used to indicate elements that function similarly.

[0052] As shown in a pre-actuated state in Figure 21 and in an actuated state in Figure 22, system 400 can utilize a similar primary container 402 puncturing configuration as aseptic puncturing system 300 described above and shown in Figures 17-20, as flow path forming member 452 is forced into and through septum 414 into cavity 408 of primary container 402 and into fluid communication with the contents therein. One difference between system 400 and system 300 is that at least one latch or cam portion 494 is part of driver retainer member 495 rather than collar 490, as shown in Figures 21 and 22.

[0053] As shown in FIG. 21 , system 400 further differs from system 300 in that it does not include a boot member including a chamber portion that forms a cavity that receives the first end portion of the channel-forming member 452 in the pre-actuated state of system 300. Rather, system 400 includes a plug 451 in which the first end portion of the channel-forming member 452 is disposed in the pre-actuated state, as shown in FIG. 21 . The plug member 451 can provide a sterile seal around the first end portion of the channel-forming member 452. In some embodiments, at least the plug 451 and the first end portion of the channel-forming member 452 therein can be sterilized (e.g., irradiated) before the primary container 402 is assembled, thereby sterilizing the first end portion of the channel-forming member 452 and maintaining such sterility of the plug 451. In some embodiments, the plug 451 can be rubber.

[0054] Upon actuation, the translation mechanism 466 can translate the primary container 402 and the collar 490 such that the at least one actuating portion 493 biases the at least one latch 494 of the driver retainer 495, causing the biasing member 497 to drive the driver 498 and the channel-defining member 452 toward the second end 406 of the primary container 402. While being driven toward the second end 406 of the primary container 402, the plug 451 at the first end portion of the channel-defining member 452 can contact the collar 490, the cap 412, the septum 414, and / or another component coupled to or proximate to the second end 406 of the primary container 402, thereby preventing further axial translation of the plug 451. When further axial translation of the plug 451 is prevented, the flow path forming member 452 may be further translated axially towards the second end 406 of the primary container 402, thereby driving the first end portion of the flow path forming member 452 through the plug 451, into and through the septum 414, and into the cavity 408 of the primary container 402, thereby placing it in fluid communication with the contents therein.

[0055] As shown in FIG. 23 , system 400 provides for partial sterilization prior to assembly, non-sterile assembly, and post-assembly sterilization without adversely affecting the contents of primary container 402. For example, components forming group or subassembly A, such as driver retainer 495, resilient member 497, driver 498, first end portion of channel-defining member 452, plug 451, and / or collar 490, can be assembled and sterilized as a unit before primary container 402 and its secured components are assembled. For example, subassembly A can be subjected to gamma radiation or other sterilization techniques that are not acceptable when the contents of primary container 402 are present. As described above, plug 451 can maintain the sterility of the first end portion of channel-defining member 452. The second end of channel-defining member 452 can similarly include a plug member to ensure complete sterility of the pathway of channel-defining member 452 and / or the first and second end portions of channel-defining member 452.

[0056] As described above, the primary container 402 can be sterilized so that the contents and cavity 408 are sterile. Thus, as shown in Figure 23, a sterile subassembly A can be coupled to the primary container 402 via the neck region 410 and collar 490 in a non-sterile environment without affecting the sterility of the first end portion of the channel-forming member 452. However, after assembly of the subassembly A and the primary container 402, the interstitial space B between the primary container 402 and the plug 451 or first end portion of the channel-forming member 452 may not be sterile, as shown in Figure 23.

[0057] To sterilize interstitial space B, as shown in FIG. 23 , system 400 can include a window 432 and a window seal 438. For example, as described above with respect to system 100 of FIGS. 1-14 , window seal 438 can be a permeable material (e.g., Tyvek® fabric) that allows a sterilant (e.g., a sterilizing gas such as EtO or VHP) to diffuse through window seal 438 and enter interstitial space B to sterilize interstitial space B. The permeability of window seal 438 can be low so that pathogens (e.g., viruses, etc.) cannot enter interstitial space B after sterilization. As another example, window seal 438 can be transparent or translucent to allow UV light to penetrate through window seal 438 and into interstitial space B to sterilize interstitial space B.

[0058] The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the invention. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It will be further understood that the terms "comprise" (and any form of "comprise," such as "comprises" and "comprising"), "have" (and any form of "have," such as "has" and "having"), "include" (and any form of "comprise," such as "includes" and "including"), and "contain" (and any form of "containing," such as "contains" and "containing") are open-ended linking verbs. Consequently, a method or device that "comprises," "has," "includes," or "contains" one or more steps or elements has those one or more steps or elements, but is not limited to having only those one or more steps or elements. Similarly, a method step or device element that "comprises," "has," "includes," or "contains" one or more features has those one or more features, but is not limited to having only those one or more features. Furthermore, a device or structure that is configured in some way is configured in at least those ways, but may also be configured in ways not listed.

[0059] The present invention has been described with reference to preferred embodiments. It will be understood that the structural and operational embodiments described herein are illustrative of multiple possible configurations that provide the same general features, characteristics, and overall system operation. Modifications and alterations will occur upon reading and understanding the above description. The present invention is intended to be construed as including all such modifications and alterations.

Claims

[Claim 1] 1. A method of puncturing a seal of a container configured to be filled with a fluid, the method comprising: puncturing the seal and the container in an injection device; the injection device further comprising a conduit, a translation mechanism, a collar coupled to the container, a lock, and a biasing member; The method comprises: actuating the translation mechanism; translating the container within the injection device via the translation mechanism; Engaging the collar with the lock to deflect at least a portion of the lock and release the biasing member; and using a preload force of the biasing member to drive the conduit through the seal and into fluid communication with the fluid.

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