Pre-filled syringe with embedded filter

Abstract

Apparatus and methods are provided for filtering syringe fluid contents through a syringe embedded filter. The filter may be sealed within a housing secured distal to the unfiltered fluid content proximal to the distal outlet of the syringe, with the exterior of the housing being fluid tight sealed against the inner wall of the syringe. Before filtration, the housing may block unfiltered fluid from entering the filter. The unfiltered fluid may be sealed between a syringe plunger, the inner wall, and the housing. Advancing the unfiltered fluid in a distal orientation can unblock the housing to cause the unfiltered fluid to flow to the filter. A fluid-tight seal within the housing may limit a fluid passage to the distal outlet as a path through the filter. The unfiltered fluid may be advanced through the unblocked housing and the filter. A filtered fluid relatively free of particulate matter having a size greater than the average pore size of the filter may flow to the distal outlet for delivery to a target site.

Description

Background Art

[0001] Prefilled syringes (PFS) are often used to deliver medications to target sites. Compared to conventional syringes, PFS offer several advantages to users. In addition to eliminating the user's need to fill the syringe with medication, these advantages typically include improved dosing accuracy and consistency; reduced exposure of the delivery needle to a non-sterile environment prior to delivery; and a reduced likelihood of accidental needle sticks.

[0002] However, the use of PFS can present several disadvantages. PFS is typically intended to be stored for a period of time (which can be quite long) before use. During storage, contact adhesion may form between the PFS syringe plunger and the inner wall of the PFS syringe barrel. Adhesion may require a high breakaway force to overcome this "stiction" to initiate movement of the plunger within the barrel. During storage, molecular deposits may form along the inner wall. Adhesion and deposits may require a high sliding force to maintain movement of the plunger within the barrel during drug delivery. High breakaway and / or sliding forces may be difficult for the user to achieve, maintain, or adjust. Applying such high forces by the user may cause discomfort to the patient receiving the PFS injection.

[0003] To minimize complications related to sticking / deposits, PFS manufacturing often includes lubrication of the inner barrel wall and / or the exterior of the plunger. While this generally improves breakaway and sliding force requirements, lubrication often introduces other complications. Over time, the lubricating material (typically silicone oil-based) can migrate from the lubricated surface, forming free-floating particles within the liquid contents of the PFS. These particles can further grow through self-aggregation and / or accumulation of drug molecules.

[0004] Independent of lubricant-related complications, prolonged drug exposure to surfaces within the PFS and exposure to drug molecules may ultimately lead to self-aggregation of drug molecules into particles.

[0005] Most of the aforementioned particles are considered non-therapeutic and potentially harmful to patients.

[0006] Particles can be removed by passing the contents of the PFS through a filter of appropriate pore size just before delivery. A standard method for filtering syringe contents can involve attaching a filter between the delivery needle and the distal delivery outlet of the syringe barrel just before delivering the drug to the target site. However, implementing this approach can violate many of the advantages of the PFS, which are safety and ease of use.

[0007] Therefore, it would be desirable to provide apparatus and methods for filtering the contents of a PFS promptly prior to drug delivery in a manner that maintains the advantages of PFS use.

[0008] The manufacture of PFS with an integrally attached filter can result in fouling of the filter with drug and / or particles, sediment, and aggregates during storage. Such fouling can reduce the ease of use and functionality of the filter during drug delivery.

[0009] Therefore, it is also desirable to provide apparatus and methods for filtering PFS contents promptly prior to drug delivery in a manner that isolates the PFS contents from the filter during storage of the PFS prior to delivery; and in a manner that allows the PFS contents to access the filter surface during delivery. Summary of the Invention

[0010] Devices and methods are provided for filtering the contents of a PFS immediately prior to drug delivery in a manner that maintains the advantages of PFS use.

[0011] Apparatus and methods are provided for filtering the contents of a PFS immediately prior to drug delivery in a manner that isolates the drug from the filter surface during storage of the PFS prior to delivery and that allows the drug to readily flow to the filter surface during delivery.

[0012] Apparatus and methods directed to the above are provided as a disclosure of a filter embedded within a PFS, proximate a distal delivery outlet of the PFS, wherein the filter is isolated from proximally stored drug prior to drug delivery and opens to allow drug flow during drug delivery.

[0013] Apparatus and methods for the above are provided as a disclosure of a filter housing secured within a PFS proximate a distal delivery outlet of the PFS, wherein the filter housing prevents drug from entering a filter housed in the filter housing prior to drug delivery; and wherein the filter housing allows drug to enter the filter during drug delivery.

[0014] The method may include a method of manufacturing a filter housing.The method may include a method of manufacturing a pre-filled syringe. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Objects and advantages of the present invention will become apparent upon consideration of the following detailed description taken in conjunction with the accompanying drawings, wherein like reference numerals refer to like parts throughout, and wherein:

[0016] Figure 1 is a schematic diagram of an apparatus according to the principles of the present invention;

[0017] Figure 2 is an isometric view of an apparatus in accordance with the principles of the present invention with selected exterior features shown in partial cross-section to provide an unobstructed view of interior features;

[0018] Figure 3is an exploded isometric view of an apparatus according to the principles of the present invention;

[0019] Figure 4 is an isometric view of an apparatus according to the principles of the present invention with selected features shown in partial cross-section;

[0020] Figure 5 is a partial cross-sectional view of an apparatus according to the principles of the present invention;

[0021] Figure 6 yes Figure 5 A cross-sectional view of the device is shown; the view is taken along line 6-6 (at Figure 5 shown in );

[0022] Figure 7 is an isometric view of an apparatus according to the principles of the present invention with selected features shown in partial cross-section, the view showing the Figure 6 The use phase following the view shown;

[0023] Figure 8 yes Figure 7 A partial cross-sectional view of the device is shown; the view is taken along line 8-8 (at Figure 7 shown in );

[0024] Figure 9 is an isometric view of an apparatus in accordance with the principles of the present invention with selected exterior features shown in partial cross-section to provide an unobstructed view of interior features;

[0025] Figure 10 is an exploded isometric view of an apparatus according to the principles of the present invention;

[0026] Figure 11 is a partial cross-sectional view of an apparatus according to the principles of the present invention;

[0027] Figure 12 yes Figure 11 A partial cross-sectional view of the device is shown; the view is taken along line 12-12 (at Figure 11 shown in );

[0028] Figure 13 is a partial cross-sectional view of an apparatus according to the principles of the present invention; Figure 12 The view is taken from the same angle and shows Figure 12 the stage of use following the view shown; and

[0029] Figure 14 is an isometric view of an apparatus according to the principles of the present invention with selected features shown in partial cross-section, the view showing the Figure 13 The use phase following the view shown. DETAILED DESCRIPTION

[0030] Devices and methods for embedding a filter in a syringe are provided. The device may include a syringe, wherein the filter is embedded in the syringe. The device may include a filter housing, wherein the filter is attached to the housing. The housing may be fixed to the syringe. The syringe may be a PFS.

[0031] The method may include a method of manufacturing the device.

[0032] The apparatus may include a fluid delivery device. The device may deliver a filtered fluid. The device may be configured to deliver the filtered fluid. The filtered fluid may be delivered from a distal outlet of the device. The device may define a longitudinal axis.

[0033] The device may include a fluid container. The container may be coaxially disposed with the longitudinal axis. The container may contain a fluid. The fluid may include a medication. The fluid may be filtered through the filter to deliver the filtered fluid.

[0034] The filter may have an average pore size. The average pore size may be from about 0.01 microns to about 10 microns. The average pore size may be from about 0.01 microns to about 1 micron. The average pore size may be from about 1 micron to about 10 microns. The filter may have any suitable average pore size. Any suitable average pore size may include an average pore size of 0.1 microns to about 0.3 microns. Any suitable average pore size may include an average pore size of about 4 microns to about 6 microns.

[0035] Any suitable average filter pore size may include an average pore size selected to be smaller than the average effective diameter of particulate matter to be filtered from the unfiltered fluid. The average effective diameter of particulate matter to be filtered from the unfiltered fluid may be approximately 0.4 microns. The average effective diameter of particulate matter to be filtered from the unfiltered fluid may be approximately 7 microns.

[0036] The present invention also contemplates the use of specialty filters configured to retain substances based on their charge. It also contemplates the use of specialty filters configured to retain substances by binding to specific molecular species attached to and / or within the specialty filter. Such species may include polypeptides. Polypeptides may include portions of antibodies. Such species may include polynucleotide chains. Polynucleotide chains may include portions of DNA. Polynucleotide chains may include portions of RNA. Specialty filters can be used to remove substances from the PFS fluid contents that are smaller than the pore size of the specialty filter (at least in the direction of fluid flow through the specialty filter). Specialty filters can also retain substances based on size.

[0037] The container may include a syringe barrel. The syringe barrel may define a barrel axis. The barrel axis may be coaxially arranged with the longitudinal axis.

[0038] The syringe barrel may include a wall. The wall may include a polymer. The polymer may include a plastic polymer. The wall may include glass. The glass may include borosilicate glass.

[0039] The wall may include an inner wall. The inner wall may be coaxial with the longitudinal axis. The inner wall may interface with the fluid. The inner wall may radially confine the fluid.

[0040] The device may include a filter. The filter may be embedded within the container. The filter may be positioned proximal to the distal outlet. The filter may be positioned transverse to the longitudinal axis. The filter may be positioned between the fluid and the distal outlet.

[0041] The device may include a filter housing. The filter may be secured in the filter housing. The filter housing may be disposed within the container. The filter housing may be disposed proximal to the distal outlet. The filter housing may be disposed between the fluid and the distal outlet. The filter housing may be secured within the container. The filter housing may be configured to maintain the filter oriented transversely to the longitudinal axis.

[0042] The filter housing may include an embedded element that seals against the inner wall. The embedded element may include external ribs. The external ribs may be positioned along the exterior of the filter housing. The exterior of the filter housing may include a profile that complements the profile of the inner wall. The exterior of the filter housing may have a convex profile that complements the concave profile of the inner wall. The embedded element may be configured to seal against the inner wall. The embedded element may be configured to prevent fluid from passing between the filter housing and the inner wall.

[0043] The filter housing may include a proximal filter cover. The filter housing may include a distal filter base. The filter may be maintained in position between the filter base and the filter cover. The filter may be maintained in a position transverse to the longitudinal axis by engagement of the filter base and the filter cover. The filter may be attached to the filter base. The filter may be attached to the filter cover.

[0044] The filter base may be configured to provide distal support to the filter. Distal support may be provided to the central region of the filter. Distal support may be provided by a proximal central protrusion of the filter base. The proximal side of the central protrusion may be positioned proximal to the distal side of the filter. The distal side of the central region of the filter may be positioned proximal to the central protrusion. The distal side of the central region of the filter may contact the central protrusion. The filter may be attached to the central protrusion. The filter may not be attached to the central protrusion.

[0045] The filter base may include a proximal edge. The proximal edge may support a proximal surface of the filter base. The filter may be attached to the proximal surface. The peripheral edge of the filter may be attached to the proximal surface.

[0046] The region of the filter that circumferentially borders the filter periphery may be joined to the proximal surface of the proximal edge. The region may be disposed on the distal side of the filter. The region may be disposed inwardly of the filter periphery.

[0047] The region may be joined to the proximal surface of the proximal edge of the filter base in a fluid-tight, sealed manner. The region may be joined to the proximal surface by welding. The weld may be produced by a laser welding method. The weld may be produced by a chemical welding method. The seal may extend circumferentially along the periphery of the filter. The seal may extend circumferentially along the entire periphery of the filter. The seal may be configured to prevent fluid from passing between the interior of the filter base and any portion of the filter periphery.

[0048] Additionally or alternatively, the filter base and filter cover may cooperate within the interior of the filter housing to provide a fluid-tight seal around the perimeter of the filter. The filter cover may include an inner filter cover circumferential sealing rib. The filter cover circumferential sealing rib may include a plurality of filter cover circumferential sealing ribs. One or more filter cover circumferential sealing ribs may be configured to extend distally within the interior of the filter housing. The filter base may include an inner filter base circumferential sealing rib. The filter base circumferential sealing rib may include a plurality of filter base circumferential sealing ribs. One or more filter base circumferential sealing ribs may be configured to extend proximally within the interior of the filter housing. An area of ​​the filter inside the perimeter of the filter may be sealed by pressing one or more filter cover circumferential sealing ribs against the filter. An area of ​​the filter may be sealed by pressing one or more filter base circumferential sealing ribs against the filter. An area of ​​the filter may be sealed by compressing the filter between one or more filter cover circumferential sealing ribs and one or more filter base circumferential sealing ribs.

[0049] The filter base may be secured to the filter cover. Interference between the convex surface of the filter cover and the concave surface of the filter base may be configured to secure the filter cover to the filter base.

[0050] The opposing surfaces of the convex filter cover surface and the concave filter base surface may be complementary in profile. The opposing surfaces may feature complementary profiles. The complementary profiles may be similar. The interference between the convex filter cover surface and the concave filter base surface may provide a fluid-tight seal. The fluid-tight seal may prevent fluid from passing between the opposing surfaces.

[0051] The interference between the concave surface of the filter cover and the convex surface of the filter base can be configured to secure the filter cover to the filter base. The opposing surfaces of the concave surface of the filter cover and the convex surface of the filter base can be complementary in profile. The opposing surfaces can feature complementary profiles. The complementary profiles can be similar. The interference between the concave surface of the filter cover and the convex surface of the filter base can provide a fluid-tight seal. The fluid-tight seal can prevent fluid from passing between the opposing surfaces.

[0052] The filter cover convex surface may be provided along a portion of an inner surface of the filter cover. The filter cover concave surface may be provided along a portion of an inner surface of the filter cover. The inner surface of the filter cover may be a circumferential inner surface of the filter cover.

[0053] The filter base concave surface may be provided along a portion of an outer surface of the filter base. The filter base convex surface may be provided along a portion of an outer surface of the filter base. The outer surface of the filter base may be a circumferential outer surface of the filter base.

[0054] The filter cover convex surface may be disposed along a portion of the filter cover's exterior surface. The filter cover concave surface may be disposed along a portion of the filter cover's exterior surface. The filter base concave surface may be disposed along a portion of the filter base's interior surface. The filter base convex surface may be disposed along a portion of the filter base's interior surface.

[0055] The fluid-tight seal provided by the interference of the opposing surfaces of the filter cover and the filter base can be a circumferential seal. The circumferential seal can prevent fluid from passing between the opposing surfaces along the entire circumference of the filter housing. The circumferential seal can prevent fluid from passing between the interior of the filter housing and the exterior of the filter housing.

[0056] The filter housing wall may be configured to seal against the inner wall of the container. The filter housing wall may be an outer circumferential wall. Sealing the filter housing wall against the inner wall of the container may prevent fluid from passing between the outer and inner walls of the filter housing.

[0057] The wall may include a filter cover sealing flange. The filter cover sealing flange may be arranged along the outer periphery of the filter cover. The filter cover sealing flange may include a plurality of filter cover sealing flanges.

[0058] The circumferential wall may include a filter base sealing flange. The filter base sealing flange may be arranged along the outer periphery of the filter base. The filter base sealing flange may include a plurality of filter base sealing flanges.

[0059] The wall may include a filter base sealing surface. The sealing surface may be supported by a section of the filter base body. The section of the filter base body supporting the sealing surface may be a distal section of the body. The sealing surface may be disposed along a conical distal outer region of the filter base. The sealing surface may be disposed along a frustoconical distal outer region of the filter base.

[0060] The exterior of the filter base may feature a profile that is at least substantially complementary to the distal inner cone of the syringe barrel. The sealing surface may be configured to rest against the distal inner cone. The distal inner cone may be positioned along a portion of the inner wall. The sealing surface may be configured to press against the distal inner cone. The sealing surface may be configured to seal against the distal inner cone. The sealing surface sealing the distal inner cone may prevent fluid from passing between the distal exterior of the filter base and the distal inner cone. The sealing surface sealing the distal inner cone may prevent fluid from passing between the housing and the inner wall.

[0061] The container may enclose a certain volume of fluid. This volume may be the pre-filled drug volume of the PFS. The pre-filled drug volume may include the drug administration volume. The pre-filled drug volume may include the volume expected to be lost during syringe preparation prior to delivery. The volume expected to be lost during syringe preparation prior to delivery may include the volume expected to be lost due to syringe priming. The volume expected to be lost during syringe preparation prior to delivery may include the volume expected to be lost due to the filtration process. The filtration process may involve a filter. The filtration process may involve a filter housing.

[0062] The pre-filled drug volume of the PFS can be sealed within the container by a syringe plunger disposed proximally of the fluid. The plunger can be configured to slidably seal against the inner wall. The plunger can be configured to prevent the fluid from flowing proximally between the inner wall and the exterior of the plunger.

[0063] The plunger may be configured to advance the fluid toward the distal outlet. Longitudinal displacement of the plunger toward the distal outlet may cause the fluid to be advanced toward the distal outlet. In order to achieve drug delivery, the user may longitudinally displace the plunger toward the distal outlet.

[0064] The device may comprise a plunger rod configured to move the plunger distally towards the distal outlet. To achieve drug delivery, a user may longitudinally displace the plunger rod towards the distal outlet.

[0065] The plunger rod may be configured to move the plunger proximally away from the distal outlet.

[0066] Prior to delivering the filtered fluid, a pre-filled drug volume may be disposed between the plunger and the filter. Prior to delivering, the volume may be disposed between the distal side of the plunger and the proximal side of the filter.

[0067] Prior to delivery of the filtered fluid, the pre-filled drug volume may be disposed between the plunger and the filter housing. Prior to delivery, the volume may be disposed between the distal side of the plunger and the proximal exterior side of the filter housing. Prior to delivery, the volume may be defined proximally by the distal side of the plunger. Prior to delivery, the volume may be defined distally by the proximal exterior side of the filter housing.

[0068] The filter cap may include a proximal exterior side of the filter housing. The filter cap may be configured to block fluid from entering the filter prior to delivery. The fluid may be configured to release the filter cap when advanced distally by the plunger to allow the distally advanced fluid to flow.

[0069] The filter housing may be configured to prevent the fluid from contacting the filter before the fluid is advanced toward the distal outlet. The filter housing may be configured to prevent the fluid from flowing to the filter before advancement. The filter housing may be configured to prevent the fluid from entering the filter before advancement.

[0070] Before the fluid is advanced toward the distal outlet, the proximal exterior side of the filter housing may be configured to prevent the fluid from contacting the filter. The proximal exterior side of the filter housing may be configured to prevent the fluid from flowing to the filter before advancement. The proximal exterior side of the filter housing may be configured to prevent the fluid from entering the filter before advancement.

[0071] Beginning to advance the fluid toward the distal outlet may increase fluid pressure on the filter housing. The increase in fluid pressure on the filter housing may change the configuration of the filter housing. Beginning distally directed advancement may increase fluid pressure on the proximal exterior side of the filter housing. The increase in fluid pressure on the proximal exterior side of the filter housing may change the configuration of the proximal exterior side of the filter housing. The increase in fluid pressure on the proximal exterior side of the filter housing may change the configuration of the proximal side of the filter housing.

[0072] After the initial advancement, the filter housing may be configured to allow fluid to enter the filter. The filter housing may be configured to allow fluid to flow to the filter after the initial advancement. The filter housing may be configured to allow fluid to contact the filter after the initial advancement.

[0073] After initial advancement, the proximal side of the filter housing may be configured to allow fluid to enter the filter. The proximal side of the filter housing may be configured to allow fluid to flow to the filter after initial advancement. The proximal side of the filter housing may be configured to allow fluid to contact the filter after initial advancement.

[0074] The filter cap may include a cylindrical body. The cylindrical body may be coaxially disposed with respect to the longitudinal axis. This coaxial arrangement may be approximate. The cylindrical body may have an interior that includes the interior of the distal cap. The cylindrical body may have an inner wall. The inner wall may be a cylindrical wall.

[0075] In an embodiment of the filter cap, the cylindrical body may include a collar disposed at a proximal end of the body. Along an interior surface of the collar, the collar may include a collar edge. The edge may extend radially inwardly.

[0076] The proximal side of the filter housing may include a proximal plug of the filter cover. The proximal plug may include a circumferential plug groove arranged along the exterior of the plug. The circumferential groove may extend radially inward into the body of the plug. The groove may have a concave profile that complements the radially inward convex profile of the collar edge. The plug and the edge may be configured to press against each other. The concave profile of the groove and the convex profile of the edge may be configured to press against each other. The mutual compression of the groove and the edge may generate interference between the plug and the collar. The interference between the plug and the collar may provide a force to maintain the plug in the collar.

[0077] The interference between the stopper and the collar provides a seal to prevent fluid from flowing between the stopper and the collar. Before fluid is initially advanced toward the distal outlet, the seal between the stopper and the collar prevents fluid from flowing into the interior of the cylindrical body. Before advancement begins, the seal between the stopper and the collar prevents fluid from flowing into the interior of the filter cap. Before advancement begins, the seal prevents fluid from flowing into the interior of the filter housing.

[0078] The seal between the proximal plug and the collar may be configured to be overcome by advancement. The seal between the plug and the collar may be configured to be overcome by initial advancement. The seal may be configured to be overcome by increasing fluid pressure on the proximal exterior side of the filter housing as advancement begins.

[0079] An increase in fluid pressure on the proximal exterior of the filter housing can apply a distally directed force to the proximal plug. The distally directed force acting on the plug can be greater than the force retaining the plug in the collar. The distally directed force acting on the plug can displace the plug distally relative to the collar into the interior of the filter cap.

[0080] As the fluid pressure on the proximal exterior of the filter housing increases, the proximal plug may undergo distal displacement relative to the collar into the interior of the filter housing. Distal displacement of the plug into the interior of the filter housing may release the seal of the collar, allowing fluid to flow through the unplugged collar, which continues to flow into the interior of the filter housing and to the filter.

[0081] The proximal stopper may define a cylindrical axis. Prior to delivery, the cylindrical axis may be coaxially arranged with the longitudinal axis. When the stopper and the collar are sealed together before fluid is initially advanced toward the distal outlet, the cylindrical axis may be coaxially arranged with the longitudinal axis. This coaxial arrangement may be substantially coaxial.

[0082] The proximal stopper may include one or more tabs extending radially outwardly perpendicular to the cylindrical axis. The tabs may be disposed distally of the stopper recess. The tabs may be disposed at the distal end of the stopper. The effective cross-sectional diameter of the stopper in the plane of the tabs may be between about 50% and about 95% of the inner diameter of the inner wall of the cylindrical body of the filter cover.

[0083] The tab may be configured to maintain the cylindrical axis coaxially oriented with the longitudinal axis during distal displacement of the stopper relative to the collar. The tab may be configured to maintain the cylindrical axis coaxially oriented with the longitudinal axis after distal displacement. The tab may maintain the cylindrical axis coaxially oriented with the longitudinal axis by interference between the tab and the inner wall of the cylindrical body of the filter cover. The tab may maintain the cylindrical axis coaxially oriented with the longitudinal axis by interference between the inner wall of the tab and the radial extreme edge. This coaxial orientation may be substantially coaxial.

[0084] The stopper may include one or more inter-tab gaps. The inter-tab gaps may be provided along the outer surface of the stopper. The inter-tab gaps may be provided between circumferentially adjacent opposing sides of the tabs. In an embodiment characterized by two or more tabs, the inter-tab gaps may be provided between circumferentially adjacent opposing sides of circumferentially adjacent tabs. The inter-tab gaps may be configured to allow fluid to flow between the proximal exterior of the filter housing and the interior of the cylindrical body during distal displacement of the stopper relative to the collar into the interior of the cylindrical body. The inter-tab gaps may be configured to allow fluid to flow between the proximal exterior of the filter housing and the interior of the cylindrical body after the stopper is distally displaced. During and after distal displacement, the inter-tab gaps may provide a passage for fluid to flow from the proximal exterior of the fluid housing into the interior of the cylindrical body and to the filter.

[0085] In another embodiment of the filter cover, the cylindrical body may include a diaphragm ring support member disposed at the proximal end of the body. The ring support member may be disposed orthogonally to the longitudinal axis. This orthogonal arrangement may be approximate. The ring support member may have a circumference concentric with the cylindrical body. The ring support member may support a diaphragm disposed within the circumference of the ring support member. The ring support member may support a diaphragm concentric with the circumference of the ring support member. The diaphragm may occupy an area concentric with the circumference of the ring support member. The diaphragm may completely occupy the area concentric with the circumference. The area may have an area spanning approximately 30% to approximately 95% of the proximal exterior side of the filter housing. The area may be placed proximally of the ring support member. The area may be placed at least approximately in the same plane as the ring support member. The area may be placed distally of the ring support member.

[0086] The filter cover may include a diaphragm. Prior to advancement, the diaphragm may seal the proximal side of the filter housing, preventing fluid from flowing from the proximal exterior of the fluid housing into the interior of the filter cover. Prior to advancement, the diaphragm may close the proximal side of the filter housing, preventing fluid from flowing into the interior of the filter cover. As the filter cover is advanced, the diaphragm may open the proximal side of the filter housing to allow fluid to flow into the interior of the filter cover.

[0087] The diaphragm may include an initially closed diaphragm. The initially closed diaphragm may prevent fluid from flowing to the filter. The diaphragm may be configured to open by distally advancing fluid. When opened, the diaphragm may be configured to provide a passage for fluid to flow to the filter.

[0088] The diaphragm may comprise a slit diaphragm. The slit diaphragm may comprise one or more than one slit. The slit diaphragm may comprise a plurality of slits. Prior to the commencement of distally directed advancement and the accompanying increase in fluid pressure on the proximal side of the distal cap, the slits may not fully penetrate the thickness of the diaphragm. The increase in fluid pressure may fully open the slits across the thickness of the diaphragm. Prior to the commencement of distally directed advancement and the accompanying increase in fluid pressure on the proximal side of the distal cap, the slits may not fully penetrate the thickness of the diaphragm along the entire length of the slits. The increase in fluid pressure may more fully open the slits along the entire length of the slits.

[0089] Prior to commencing distally directed advancement and the accompanying increase in fluid pressure on the proximal side of the distal cap, the slits may completely penetrate the thickness of the membrane. Prior to commencing advancement, the parallel opposing sides of the slits may be compressed against one another to provide a seal to prevent fluid from flowing from the proximal exterior of the filter cap into the interior of the filter cap.

[0090] The diaphragm may comprise one or more diaphragm flaps. The diaphragm flaps may be closed along opposite sides of the slit. When closed, the diaphragm flaps may present an area that is coextensive with the diaphragm. When the diaphragm flaps are opened by increasing fluid pressure on the closed proximal exterior side of the filter housing, the diaphragm flaps may extend distally into the filter cover. When the diaphragm flaps are open, portions of the diaphragm flaps may be disposed within the interior of the cylindrical body. The portions of the opened diaphragm flaps may be disposed within the interior of the cylindrical body at an acute angle to the closed position of the diaphragm flaps. The portions of the opened diaphragm flaps may be disposed substantially parallel to the inner wall of the cylindrical body. The portions of the opened diaphragm flaps may be disposed within the interior of the cylindrical body at an obtuse angle to the closed position of the diaphragm flaps.

[0091] When opened, the diaphragm flaps can be folded distally into the filter cover. The diaphragm flaps can be folded at a hinge element supported by the diaphragm ring support. The hinge element may include an area along the distal side of the diaphragm. The area along the distal side may include a groove extending into the diaphragm material. The groove may extend proximally from the distal surface into the material of the diaphragm and / or may extend distally from the proximal surface into the material. The groove extending into the diaphragm material may be arranged along a line segment surrounded by the ring support. The groove extending into the diaphragm material may be arranged along an arc concentric with the cylindrical body. The material of the diaphragm along the groove can be more easily folded than the material of the diaphragm arranged away from the groove. The material of the diaphragm along the groove can be more easily folded distally than the material of the diaphragm arranged away from the groove.

[0092] The diaphragm may be configured to reseal after opening. The diaphragm may be configured to reseal after fluid flow ceases. The diaphragm may be configured to reseal after distally directed fluid advancement ceases.

[0093] The apparatus may include a filter housing for embedding within a drug container of a device for delivering a filtered drug. The device may define a longitudinal axis. The device may deliver the filtered drug from a distal outlet of the device. The filter housing may be configured to be embedded within the container proximal to the distal outlet.

[0094] The filter housing may include a filter base. The filter base may be configured to support the filter. The filter may be disposed on the filter base.

[0095] The filter may comprise an acrylic polymer. The filter may comprise polyethersulfone. The filter may comprise any suitable material. Any suitable material may comprise polyvinylidene fluoride.

[0096] The filter may be configured to prevent particles larger than the maximum pore size of the filter from passing through the filter. The filter may be configured to retain particles larger than the maximum pore size of the filter. The filter may be configured to prevent particles larger than the average pore size of the filter from passing through the filter. The filter may be configured to retain particles larger than the average pore size of the filter.

[0097] The average pore size of the filter can be about five microns. The average pore size of the filter can be any suitable average pore size. Any suitable average pore size can be about 0.2 microns.

[0098] The filter housing may be configured to provide a seal around the filter. When sealed, the periphery may be configured to prevent the passage of medication around the periphery.

[0099] The exterior of the filter housing may be configured to provide a seal against an inner wall of the container. The seal may be configured to prevent the drug from flowing distally between the inner wall and the filter housing.

[0100] The medication may be disposed within the container. The medication may be disposed within the container proximal to the filter. The medication may be disposed within the container distal to a longitudinally slidable plunger. The plunger may be configured to seal against the inner wall. The plunger may be configured to slidably seal against the inner wall. The plunger may be configured to propel the medication toward the distal outlet.

[0101] The filter housing may include a filter cover. The filter cover may be configured to engage with the base.

[0102] The drug may contact the proximal external features of the filter cap. Before delivering the drug, the filter cap may be configured to block the drug from entering the filter. Before delivering the drug, the proximal external features of the filter cap may be configured to block the drug from entering the filter.

[0103] The filter cap can be configured to be unblocked by distal advancement of the drug over the proximal exterior feature of the filter cap. The unblocked filter cap can allow the drug to flow to the filter.

[0104] The proximal exterior feature of the filter cover may include a proximal stopper disposed in the collar of the filter cover. The proximal stopper may seal the collar. The proximal stopper may seal the collar to prevent the flow of the drug. The proximal stopper may seal the collar to prevent the drug from flowing into the interior of the proximal cover. The proximal stopper may seal the collar to prevent the drug from flowing toward the filter and into the interior of the filter housing. The proximal stopper may be configured to be displaced distally relative to the collar by distally advancing the drug. Displacing the proximal stopper relative to the collar may release the seal of the collar, allowing the drug to flow through the collar.

[0105] The proximal exterior feature of the filter cap may include a membrane. The membrane may be a slit membrane. The membrane may be initially closed. Prior to drug delivery, the membrane may be sealed to prevent drug flow. Prior to drug delivery, the membrane may be closed to prevent drug flow. The membrane may be configured to open upon distal advancement of the drug. The opened membrane may provide a passageway for drug flow.

[0106] Methods of manufacturing an apparatus may include a method of manufacturing a drug device for delivering a filtered drug from a distal outlet of the delivery device.The device may define a longitudinal axis.

[0107] A method of manufacturing the device may include providing a drug container disposed coaxially with the axis. The container may have a distal outlet. The container may have a proximal opening.

[0108] A method may include assembling a filter housing. Assembling the filter housing may include providing a filter base. The filter base may be configured to support a filter. Assembling the filter housing may include positioning the filter on a surface of the base. The surface may be an external feature of the base. The surface may be an upper surface of the base.

[0109] Assembling the filter housing may include sealing the periphery of the filter to prevent fluid flow. The filter housing may include an internal surface configured to seal the periphery of the filter to prevent fluid flow. The internal surface may be a surface of a base. The internal surface may be a circumferential surface of the base. The internal surface may be a face of the base. The filter may be sealed to the internal surface via a laser welding process. The filter may be sealed to the internal surface via any suitable method. Any suitable method may include depolymerization and subsequent repolymerization of materials of the internal surface and / or filter with each other.

[0110] Assembling the filter housing may include providing a filter cover. Assembling the filter housing may include engaging the base with the filter cover. The cover may include ribs. The ribs may be disposed on an exterior of the cover. The ribs may be disposed on an exterior circumference of the cover. The ribs may surround an exterior circumference of the cover. The ribs may be configured to seal against an inner wall of the container.

[0111] The cap may include an external feature. The external feature may include a structural component of the cap. The external feature may be configured to block fluid from entering the filter prior to delivery. The external feature may be configured to be unblocked to provide fluid access to the filter during delivery.

[0112] The method may include introducing the filter housing into the container. The filter housing may be introduced into the container through a proximal opening. The filter housing may be introduced into the container with the base disposed distally. The filter housing may be introduced into the container with the base disposed distally relative to the axis.

[0113] The method may include embedding the filter housing in the container.The filter housing may be embedded in the container proximal to the distal outlet.

[0114] The method may include sealing the rib against the inner wall. Sealing the rib against the inner wall may provide a fluid-tight seal that prevents the drug from flowing between the exterior of the cap and the inner wall. Sealing the rib against the inner wall may provide a fluid-tight seal that prevents the drug from flowing between the exterior of the filter housing and the inner wall.

[0115] The method may include transferring the drug to the container via the proximal opening.

[0116] The method may include providing a longitudinally slidable plunger. The method may include inserting the plunger into the container through the proximal opening. The plunger may be configured to seal the drug within the container. The plunger may be configured to slideably seal against the inner wall. The plunger may be configured to advance the drug toward the distal outlet. The insertion may be performed without advancing the drug distally sufficiently to unblock the external feature.

[0117] The method may include providing a plunger rod. The method may include introducing the plunger rod into the container via the proximal opening. The plunger rod may be configured to distally advance the plunger within the container. The plunger rod may be configured to abut a proximal side of the plunger. The plunger rod may be configured to attach to the proximal side of the plunger.

[0118] The filter housing can be introduced into the container, wherein the external feature is disposed proximally relative to the axis. The external feature can include an initially closed membrane configured to be opened by distally advancing the drug, thereby providing a passage for drug flow. The external feature can include a proximal plug disposed within and sealing a proximal collar of the filter cap. The plug can be configured to be displaced distally relative to the collar by distally advancing the drug, thereby releasing the seal of the collar to allow drug flow therethrough.

[0119] A medicament may include a formulation of one or more compounds. A compound may include a naturally occurring substance. A compound may include a substance derived from a naturally occurring substance. A compound may include a synthetically produced substance. A compound may include a chimeric substance. A compound may include an engineered substance. A compound may include a humanized substance. A compound may include a substance produced by recombinant technology. A compound may include a substance modified by recombinant technology.

[0120] Compounds may include drugs accepted for therapeutic patient treatment. Compounds may include substances used in therapeutic protocols. Compounds may include substances used in diagnostic protocols. Compounds may include substances used in experimental protocols. Compounds may include substances compatible with the devices and methods of the present invention.

[0121] The drug may include any of the agents listed herein, alone or in combination with one or more other listed agents or with one or more other unlisted agents. The agent may include anti-glaucoma drugs, other eye drugs, neuroprotectants, antimicrobials, anti-inflammatory agents (including steroids and non-steroidal compounds), and biologics including hormones, enzymes or enzyme-related components, antibodies or antibody-related components, oligonucleotides (including DNA, RNA, short interfering RNA and other suitable oligonucleotides, such as antisense oligonucleotides), DNA / RNA vectors, viruses or viral vectors, peptides and proteins. The agent may include anti-angiogenic agents, including angiostatin, anecortave acetate, thrombospondin, vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitors, and anti-VEGF drugs such as ranibizumab Bevacizumab Pegaptanib Sunitinib and sorafenib, as well as any known small molecules and transcription inhibitors with anti-angiogenic effects; Ophthalmic drugs, including glaucoma drugs, such as adrenergic antagonists, including beta-blockers such as atenolol, propranolol, metipranolol, betaxolol, carteolol, levobetaxolol, levobunolol and timolol. The agent may include platelet-derived growth factor (PDGF) inhibitors and anti-PDGF drugs. The agent may include transforming growth factor (TGF) inhibitors and anti-TGF drugs. The pharmaceutical agent may include an anti-inflammatory agent (including glucocorticoids and corticosteroids), such as betamethasone, cortisone, dexamethasone, dexamethasone 21-phosphate, methylprednisolone, prednisolone 21-phosphate, prednisolone acetate, prednisolone, loteprednol, medrysone, fluocinolone, triamcinolone acetonide, triamcinolone, beclomethasone, budesonide, flunisolide, fluorometholone, fluticasone, hydrocortisone, hydrocortisone acetate, and rimexolone; and nonsteroidal anti-inflammatory agents include diclofenac, flurbiprofen, ibuprofen, bromfenac, nepafenac, ketorolac, salicylates, indomethacin, naproxen, naproxen, piroxicam, and nabumetone. The pharmaceutical agent may include an anti-cytokine agent; the pharmaceutical agent may include an anti-interleukin-6 agent, such as tocilizumab. The agent may include an anti-complement agent, including those targeting complement factor D (such as an anti-complement factor D antibody or an antigen-binding fragment thereof), such as lambalizumab, and those targeting complement factor H (such as an anti-complement factor H antibody or an antigen-binding fragment thereof). The agent may include an angiogenin-specific agent, such as an angiopoietin-2 antibody or an antigen-binding fragment thereof. The agent may include human growth hormone. The agent may include any suitable agent, whether or not listed above.

[0122] The drug may include one or more derivatives of any of the above-mentioned drugs. The drug may include an advanced form of any of the above-mentioned drugs. The drug may include a mutant form of any of the above-mentioned drugs. The drug may include a combination of any of the above-mentioned drugs. These combinations may be incorporated into multispecific molecules. Multispecific molecules may exhibit properties of their component parts. Multispecific molecules may exhibit properties that differ from any of their component parts.

[0123] The volume of the drug encapsulated in the device can be determined substantially during manufacture. The volume can be set in the case of expected drug loss, which can be caused by manipulation of the device before the final distal displacement of the plunger in the syringe barrel toward the filter to perform the drug delivery stroke. This manipulation can include syringe priming. The volume can depend on the expected scenario of the device. An exemplary range of volume values ​​can include approximately 0.025 ml to approximately 0.05 ml, approximately 0.05 ml to approximately 0.1 ml, approximately 0.1 ml to approximately 0.25 ml, approximately 0.25 ml to approximately 0.5 ml, approximately 0.5 ml to approximately 1 ml, approximately 1 ml to approximately 2 ml, approximately 2 ml to approximately 3 ml, approximately 3 ml to approximately 4 ml, approximately 4 ml to approximately 5 ml, approximately 5 ml to approximately 6 ml, approximately 6 ml to approximately 7 ml, approximately 7 ml to approximately 8 ml, approximately 8 ml to approximately 9 ml, approximately 9 ml to approximately 10 ml, or any other suitable volume range. The volume of any other suitable range can be encapsulated in the device.

[0124] Providing the filter base may include manufacturing the filter base. Providing the filter cover may include manufacturing the filter cover. The filter base and / or the filter cover may be manufactured by a molding method. The filter base and / or the filter may be manufactured by an injection molding method. The injection molding method may include a dual injection molding method.

[0125] Providing the plunger may include manufacturing the plunger. Providing the plunger rod may include manufacturing the plunger rod. Manufacturing the plunger and / or the plunger rod may be accomplished by a molding process. Manufacturing the plunger and / or the plunger rod may be accomplished by an injection molding process. The injection molding process may include a dual injection molding process.

[0126] The method may involve selecting materials for manufacturing components of the delivery device. The materials may be selected based on their material properties. The material properties of the selected materials may facilitate the operation of the device. The material properties of the selected materials may facilitate the operation of the delivery device. These properties may include chemical inertness, elasticity, transparency, and other suitable properties. Other suitable properties may include hardness.

[0127] For example, for a filter, properties may include average pore size, elasticity against impact stress, and other relevant properties. Other relevant properties may include chemical inertness. Other relevant properties may include sealing against the filter housing material.

[0128] The filter may include a filter material. The filter material may include a polymeric material. The filter material may include an acrylic polymer. The filter material may include polyethersulfone. The filter material may include any suitable filter material. Any suitable filter material may include polyvinylidene fluoride.

[0129] The plunger may include a plunger material. The plunger material may include a polymeric material. The plunger material may include an elastomeric material. The plunger material may include a thermoplastic elastomer (TPE). The plunger material may include natural rubber. The plunger material may include a compound made from natural rubber. The plunger material may include a synthetic rubber. The plunger material may include a compound made from synthetic rubber. The plunger material may include silicone rubber. The plunger material may include a compound made from silicone rubber. The plunger material may include butyl rubber. The plunger material may include a compound made from butyl rubber. The plunger material may include a material selected to reduce interaction between the plunger and the drug. The plunger material may include an elastomeric material. The plunger material may include a material having a hardness of less than about 80 Shore A (ASTM D2240 Type A hardness scale). The plunger material may facilitate movement of the plunger within the barrel. The plunger material may facilitate engagement of the plunger with the inner wall of the barrel. The plunger material may facilitate sealing of the plunger against the inner wall of the barrel.

[0130] The plunger material may include a plunger lubricating material. The plunger lubricating material may coat the plunger material. The plunger material may carry the plunger lubricating material. The plunger lubricating material may include polytetrafluoroethylene (PTFE). The plunger lubricating material may include ethylene tetrafluoroethylene (ETFE). The plunger lubricating material may include silicone oil. The silicone oil may be a cross-linked silicone oil. The plunger lubricating coating may include a material selected to reduce the interaction between the plunger and the drug. The plunger lubricating material may facilitate movement of the plunger within the barrel. The plunger lubricating material may facilitate engagement of the plunger with the inner wall of the barrel. The plunger lubricating material may facilitate sealing of the plunger against the inner wall of the barrel.

[0131] The plunger rod may include a rod material. The rod material may include a polymeric material. The rod material may include a thermoplastic polymer. The rod material may include polyoxymethylene. The rod material may include polypropylene. The rod material may include nylon. The rod material may include PTFE. The rod material may include ABS. The rod material may include polycarbonate. The rod material may include polysulfone. The rod material may include an acrylic polymer. The rod material may include poly(methyl methacrylate) (PMMA). The rod material may include a rigid material. The rod material may include a material having a hardness greater than about 80 Shore A durometer. The rod material may include a material having a low coefficient of friction. The rod material may include a material having a coefficient of friction of about 0.01 to about 0.5.

[0132] The rod material may include a rod lubricating material. The rod lubricating material may coat the rod material. The rod material may carry the rod lubricating material. The rod lubricating material may include one or more of the plunger lubricating materials. For example, the rod lubricating material may include silicone oil. The silicone oil may be cross-linked silicone oil. The rod lubricating material may facilitate movement of the plunger rod within the proximal opening of the container.

[0133] The container may include a barrel material. The barrel material may include a polymeric material. The barrel material may include an amorphous material. The barrel material may include a polymer. The barrel material may include a thermoplastic polymer. The barrel material may include a cycloolefin polymer (COP). The barrel material may include a cycloolefin copolymer (COC). The barrel material may include polypropylene. The barrel material may include PMMA. The barrel material may include polycarbonate. The barrel material may include glass. The barrel material may include type 1 borosilicate glass. The barrel material may include a translucent material. The barrel material may include a transparent material.

[0134] The barrel material may include a barrel lubricating material. The barrel lubricating material may coat the barrel material. The barrel lubricating material may coat the inner wall of the container. The barrel material may carry the barrel lubricating material. The barrel lubricating material may include one or more of the plunger lubricating materials. For example, the barrel lubricating material may include silicone oil. The silicone oil may be cross-linked silicone oil. The barrel lubricating material may facilitate movement of the plunger within the barrel.

[0135] The filter base may include a filter base material. The base material may include a polymeric material. The base material may include a thermoplastic elastomer (TPE). The base material may include one or more of the plunger materials. The base material may include a material that is harder than the plunger material.

[0136] The filter cover may include a filter cover material. The cover material may include a polymeric material. The cover material may include a thermoplastic elastomer (TPE). The cover material may include one or more of the plunger materials. The cover material may include a material harder than the plunger material. The cover material may include a material less hard than the plunger material.

[0137] The cover material may include a diaphragm material. The cover material may include a plug material. The plug material and / or the diaphragm material may include a material harder than the plunger material. The plug material and / or the diaphragm material may include a material less hard than the plunger material.

[0138] The apparatus and method described herein are exemplary. The apparatus and method according to the present invention will now be described with reference to the figures. The figures illustrate exemplary features of an apparatus according to the principles of the present invention.

[0139] Some devices may omit features shown and / or described in conjunction with the exemplary devices. Some embodiments may include features not shown or described in conjunction with the exemplary methods. Features of the exemplary devices may be combined. For example, one exemplary embodiment may include features shown in conjunction with another exemplary embodiment.

[0140] An apparatus may involve some or all of the features of the example apparatus and / or some or all of the steps of the example method.

[0141] The apparatus and method of the present invention will be described in conjunction with the embodiments and features of exemplary devices. The apparatus will now be described with reference to the accompanying drawings, which form a part hereof. It is to be understood that other embodiments may be utilized and structural, functional, and procedural modifications may be made without departing from the scope and spirit of the present invention.

[0142] The figure uses the same part numbers in the tens and units places to refer to the same features.

[0143] Figure 1 An exemplary fluid delivery device 100 is shown in simplified form. The delivery device 100 can define a longitudinal device axis L. (Longitudinal axis L should be understood as defined in all subsequent figures, even if not shown.) The delivery device 100 can include a container 102. The container 102 can be disposed coaxially with axis L. The container 102 can include a syringe barrel. The container 102 can include an inner barrel wall 106. The container 102 can contain a fluid 165. The container 102 can be prefilled with the fluid 165. The fluid 165 can include a medication.

[0144] The filter housing 120 can be secured within the container 102. The filter housing 120 can be secured within the container 102 proximal to the distal outlet 104. The filter housing 120 can be positioned orthogonal to the axis L. The filter housing 120 can include an insert element 122. The insert element 122 can facilitate securing the filter housing 120 within the container 102.

[0145] The filter housing 120 can be secured in the container 102 to be fluid-tight. The insert element 122 can be pressed against the inner wall 106. The pressing of the insert element 122 against the inner wall 106 can prevent the fluid 165 from passing between the inner wall 106 and the longitudinal exterior of the filter housing 120.

[0146] The filter housing 120 may include a distal filter base 130. The filter housing 120 may include a proximal filter cover 140. The filter base 130 and the filter cover 140 may be secured to each other. The filter base 130 and the filter cover 140 may be sealed to each other.

[0147] The filter housing 120 may include the filter 110. The filter housing 120 may support the filter 110. The filter 110 may be attached within the filter housing 120. The filter 110 may be sealed into the filter housing 120. The filter housing 120 may maintain the filter 110 across the axis L.

[0148] Figure 2 An exemplary fluid delivery device 200 is shown. The delivery device 200 may include a device having a Figure 120, 210, filter housing 220, filter base 230, filter cap 240, and fluid 265 (illustratively depicted as a spot).

[0149] The device 200 can include a syringe plunger rod 268. The plunger rod 268 can abut the syringe plunger 266. The plunger rod 268 can be connected to the plunger 266.

[0150] As depicted, fluid 265 can be bounded by plunger 266, inner wall 206, and filter housing 220. More specifically, fluid 265 can be bounded by a distal surface of plunger 266; by inner wall 206; and by proximal exterior features of filter cap 240.

[0151] The plunger rod 268 can be configured to move the plunger 266 distally within the container 202. The plunger 266 can be configured to propel the fluid 265 toward the distal outlet 204. The distally propelled fluid 265 can be configured to apply a distally directed force to the proximal exterior features of the filter cap 240.

[0152] Filter 210 is shown just proximal to filter base 230. An area proximal to filter 210 and distal to the proximal external features of filter cap 240 that define fluid 265 is depicted as being free of fluid 265. Similarly, outlet 204 is depicted as being free of fluid. Generally speaking, the region of the hollow device disposed distal to the proximal external features of filter cap 240 is depicted as being free of fluid in the figure, illustrating the present invention in an operational configuration prior to commencing the advancement of fluid 265 toward distal outlet 204. Such an operational configuration may be considered a pre-filtration configuration, including a PFS storage configuration.

[0153] Figure 3 Details of device features are shown that may have similarities to those of delivery devices 100 and 200 ( Figure 1 and Figure 2 322a and 322b (collectively, insert elements 322), a filter base 330, and a filter cover 340.

[0154] Figure 3 The exploded view of FIG. 3 depicts the filter base 330 and the filter cover 340 separated from each other, with the filter 310 spaced therebetween. Figure 3Also depicted are filter cover proximal plug 341 and filter cover proximal collar 342 separated from one another. Figure 3 Provides an unobstructed view of features of the filter housing 320 that are visible when the filter housing 320 is assembled (such as Figure 2 This may be more difficult to discern in the view of the filter housing 220 shown.

[0155] The filter 310 can include a filter center region 312. The filter 310 can include a filter perimeter 314. The perimeter 314 can be a distal perimeter. The perimeter 314 can extend radially inward from the periphery of the filter 310.

[0156] The filter base 330 can include a proximal central protrusion 332. The central protrusion 332 can be configured to provide support to the filter 310. The central protrusion 332 can be configured to provide support to the central region 312.

[0157] Filter base 330 may include a proximal edge 335. Proximal edge 335 may support a proximal edge surface 334. Proximal edge 335 may be configured to provide support to filter 310. Proximal edge 335 may be configured to provide support to peripheral edge 314. Peripheral edge 314 may be disposed on surface 334. Peripheral edge 314 may be sealed to surface 334. The entirety of peripheral edge 314 may be sealed to surface 334. Peripheral edge 314 may be sealed to surface 334 along the entirety of surface 334. Sealing peripheral edge 314 along surface 334 may provide a fluid-tight seal configured to prevent fluid from passing between the interior of filter base 330 and any perimeter of filter 310.

[0158] Filter base 330 may include a circumferential convex surface 336. Filter base 330 may include a circumferential concave surface 338. Convex surface 336 and / or concave surface 338 may be configured to mechanically interfere with distal internal features (not shown) of filter cover 340. The interference of convex surface 336 and / or concave surface 338 with the internal features of filter cover 340 may assemble filter base 330 and filter cover 340 together. The interference of convex surface 336 and / or concave surface 338 with the internal features of filter cover 340 may secure filter base 330 and filter cover 340 together.

[0159] The convex surface 336 and / or the concave surface 338 can be configured to press against an internal feature of the filter cover 340. Pressing the convex surface 336 and / or the concave surface 338 against the internal feature of the filter cover 340 can provide a fluid-tight seal between the filter base 330 and the filter cover 340. The internal feature of the filter cover 340 can be configured to press against the convex surface 336 and / or the concave surface 338. Pressing the internal feature of the filter cover 340 against the convex surface 336 and / or the concave surface 338 can provide a fluid-tight seal between the filter base 330 and the filter cover 340.

[0160] Filter cover 340 can include a hollow cylindrical body 324. Cylindrical body 324 can include a distal edge 326. Distal edge 326 can be configured to receive at least a portion of filter base 330. Distal edge 326 can be configured to longitudinally receive filter 310 and proximal edge 335.

[0161] Cylindrical body 324 may include distal insert element 322a. Insert element 322a may be positioned along distal edge 326. Insert element 322a may be positioned along the circumferential exterior of cylindrical body 324. Cylindrical body 324 may include proximal insert element 322b. Insert element 322b may be positioned along the circumferential exterior of cylindrical body 324.

[0162] Each of the insert elements 322 can be configured to press against an inner barrel wall of the delivery device (such as against the inner wall 106 of the delivery device 100). Figure 1 1 .) The compression of the insert elements 322 against the inner barrel wall may provide a fluid-tight seal between the inner barrel wall and each of the insert elements 322.

[0163] Proximal stopper 341 may include a stopper recess 343a. Recess 343a may extend radially inwardly into the body of stopper 341. Recess 343a may extend circumferentially around the body. Proximal stopper 341 may include a proximal recess protrusion 343b. Recess 343a may include recess protrusion 343b. Recess protrusion 343b may extend circumferentially around the body. Recess protrusion 343b may include a proximal side of recess 343a. Recess protrusion 343b may extend shallower than the full depth of recess 343a into the body.

[0164] The proximal collar 342 may include an inwardly protruding proximal edge 344. The edge 344 may be configured to mechanically interfere with the groove 343a. The interference of the groove 343a and the edge 344 may assemble the stopper 341 and the collar 342 together. The interference of the groove 343a and the edge 344 may secure the stopper 341 and the collar 342 together. The groove protrusion 343b may be configured to maintain the stopper 341 within the collar 342 by interfering with the edge 344 to provide contact / friction to resist distally directed forces that may act on the proximal exterior of the stopper 341.

[0165] The edge 344 can be configured to press against the groove 343a. The pressing of the edge 344 against the groove 343a can provide a fluid-tight seal between the plug 341 and the collar 342, thereby sealing the assembled filter cover 340 against the fluid in the pre-filtration configuration of the device.

[0166] Figure 4 Details of device features are shown that may have similarities to those of delivery devices 100 and 200 ( Figure 1 and Figure 2 The same relationship, property and function of one or both of the features shown separately and / or Figure 3 4. As shown in FIG. 4, as indicated by the same reference numerals as described above, these device features may include container 402, distal outlet 404, inner wall 406; filter 410; insert element 422, cylindrical body 424, rim 426; filter base 430, rim 435, convex surface 436, concave surface 438; filter cap 440, stopper 441, collar 442, groove 443a, groove protrusion 443b, inwardly protruding rim 444; and fluid 465.

[0167] Figure 4 Cylindrical body 424 is shown secured within container 402 with insert elements 422a and 422b pressed against inner wall 406. Insert elements 422 pressed against inner wall 406 may provide a fluid-tight seal preventing fluid 465 from passing between inner wall 406 and the longitudinal exterior of cylindrical body 424.

[0168] The inwardly protruding proximal edge 444 is shown interfering with the stopper groove 443a and the stopper groove protrusion 443b. The interference of the edge 444 with the groove 443a and the groove protrusion 443b can assemble the stopper 441 and the collar 442 together. The interference of the edge 444 with the groove 443a and the groove protrusion 443b can secure the stopper 441 and the collar 442 together.

[0169] The interference of edge 444 with groove 443a and / or with groove protrusion 443b can provide a contact / friction force that can maintain stopper 441 within collar 442. The contact / friction force can be configured to resist a distally directed force that can be applied to the proximal exterior of stopper 441 by distally advancing fluid 465.

[0170] The increase in pressure applied to the fluid 465 can result in an increase in the magnitude of the distally directed force applied by the distally propelled fluid 465 to the proximal exterior of the plug 441. The increase in the magnitude of the distally directed force applied by the distally propelled fluid 465 to the proximal exterior of the plug 441 can overcome the contact / friction force maintaining the plug 441 within the collar 442.

[0171] Edge 444 can be configured to press against groove 443a. Edge 444 can be configured to press against groove protrusion 443b. The pressing of edge 444 against groove 443a and / or against groove protrusion 443b can provide a fluid-tight seal between plug 441 and collar 442. The seal between plug 441 and collar 442 can prevent fluid 465 from passing between plug 441 and collar 442. The seal between plug 441 and collar 442 can prevent fluid 465 from entering interior 428 of cylindrical body 424.

[0172] The materials and / or geometries of the collar 442 (particularly the edge 444) and / or the plug 441 (particularly the groove 443a and the groove protrusion 443b) can be preselected to maintain the plug 441 sealed within the collar 444 under the pre-filtration pressure of the fluid 465 (as shown); and (not shown), during the initial advancement of the fluid 465 toward the distal outlet 404, at a higher pressure that is easily achieved by the user, the plug 441 is displaced distally relative to the edge 444 into the interior 428, opening the collar 442 to allow the fluid 465 to flow through the edge 444.

[0173] Filter cap proximal plug 441 may include a distal plug face 445. Plug face 445 may be supported by a distal section of the body of plug 441. The distal section of the body of plug 441 may extend radially outward as tabs 447. Tabs 447 may extend orthogonally to a cylindrical axis (not shown) defined by plug 441. The cylindrical axis may intersect the center of face 445. The cylindrical axis may intersect the center of the proximal exterior face of plug 441.

[0174] The plug 441 can be maintained within the collar 444 (as shown), with the cylindrical axis oriented approximately coaxially with at least the longitudinal axis L (not shown). When the plug 441 is displaced into the interior 428 upon initially advancing the fluid 465 toward the distal outlet 404, the tab 447 can maintain the cylindrical axis oriented approximately coaxially with the longitudinal axis. During and after distal displacement of the plug 441, the radial extreme edges of the tab 447 can interfere with the inner wall 429 of the cylindrical body 424, thereby maintaining the cylindrical axis approximately coaxially with the longitudinal axis L. Interference of the radial extreme edges of the tab 447 with the inner wall 429 can occur intermittently as the plug 441 oscillates during its longitudinal transport toward the filter 410, and thereafter as the fluid 465 continues to flow distally through the plug 441 toward the filter 410. This intermittent interference can prevent the plug 441 from becoming deflected against the sides of the inner wall 429 and becoming wedged therebetween.

[0175] The filter cover proximal plug 441 can include an inter-tab gap 449 disposed between circumferentially adjacent opposing sides of the tabs 447, the inter-tab gap being orthogonal to the cylindrical axis. The inter-tab gap 449 can provide a path for fluid 465 to flow distally through the plug 441 toward the filter 410 during and after distal displacement of the plug 441.

[0176] During and after distal displacement of the plug 441, the distal flow of fluid 465 through the plug 441 via the inter-tab gaps 449 (as well as the distal flow of fluid 465 between the inner wall 429 and the radial extreme edges of the tabs 447) can provide a cushion between the plug 441 and the inner wall 429. During distal displacement of the plug 441, when the face 445 approaches the filter 410, the fluid 465 flows across the face 445, which can provide a cushion between the plug 431 and the filter 410. After distal displacement of the plug 441, when the face 445 approaches the proximal side of the filter 410, the fluid 465 flows across the face 445, which can provide a cushion between the plug 431 and the filter 410.

[0177] Filter cover distal edge 426 may extend radially outward as an insert element 422a. Edge 426 may extend radially inward as a filter cover convex surface 446. Filter cover convex surface 446 may be positioned along edge 426. Filter cover convex surface 446 may be positioned along the inner circumference of cylindrical body 424. Filter cover concave surface 448 may be positioned parallel to filter cover convex surface 446. Filter cover concave surface 448 may be positioned along the inner circumference of cylindrical body 424.

[0178] Filter cover convex surface 446 can mechanically interfere with filter base concave surface 438. The interference of filter cover convex surface 446 and filter base concave surface 438 can assemble filter cover 440 and filter base 430 together. The interference of filter cover convex surface 446 and filter base concave surface 438 can secure filter cover 440 and filter base 430 together. Filter cover convex surface 446 can be configured to press against filter base concave surface 438. The pressing of filter cover convex surface 446 against filter base concave surface 438 can provide a fluid-tight seal between filter cover 440 and filter base 430. The seal between filter cover 440 and filter base 430 can prevent fluid 465 from passing between filter cover convex surface 446 and filter base concave surface 438.

[0179] Filter base convex surface 436 can mechanically interfere with filter cover concave surface 448. The interference of filter base convex surface 436 and filter cover concave surface 448 can assemble filter cover 440 and filter base 430 together. The interference of filter base convex surface 436 and filter cover concave surface 448 can secure filter cover 440 and filter base 430 together. Filter base convex surface 436 can be configured to press against filter cover concave surface 448. The pressing of filter base convex surface 436 against filter cover concave surface 448 can provide a fluid-tight seal between filter cover 440 and filter base 430. The seal between filter cover 440 and filter base 430 can prevent fluid 465 from passing between filter base convex surface 436 and filter cover concave surface 448.

[0180] Distal to the seal between the filter base 430 and the filter cover 440, the filter base 430 can include a (truncated) conical surface 431. Surface 431 can be complementary in profile to the distal inner cone of the container 402 leading to the distal outlet 404. Surface 431 can be pressed against the distal inner cone. The pressing of surface 431 against the distal inner cone can provide a fluid-tight seal between surface 431 and the distal inner cone. The seal between surface 431 and the distal inner cone can prevent filtered fluid from exiting the passage 433 to reach the distal outlet 404 and passing between surface 431 and the distal inner cone during the propulsion of fluid 465 toward the distal outlet 404.

[0181] Surface 431 may terminate distally in a filter base end projection 437. End projection 437 may comprise the distal-most feature of filter base 430.

[0182] Figure 5 Will provide Figure 4 A partial cross-sectional view of the device, Figure 4 The view is taken in the plane of the page and is located on the far side of the plug face 445.

[0183] Figure 5 Details of device features are shown that may have similarities to those of delivery devices 100 and 200 ( Figure 1 and Figure 2 The same relationship, property and function of one or both of the features shown separately and / or Figure 3 and / or Figure 4 534, rim 535, filter base convex surface 536, end protrusion 537, filter base concave surface 538; and filter cover convex surface 546 and filter cover concave surface 548.

[0184] Figure 5 The central region 512 of the filter 510 is depicted positioned immediately proximal to the central protrusion 532. The central protrusion 532 can support the central region 512. The support of the central region 512 can resist distally directed forces acting on the filter 510 during distally directed advancement of the fluid within the interior 528, both during and after initial advancement of the fluid contents of the device (not shown) toward the distal outlet 504.

[0185] Peripheral rim 514 of filter 510 is shown positioned immediately proximal to rim surface 534. Filter 510 can be sealed to rim surface 534 along peripheral rim 514, providing a fluid-tight seal that prevents fluid from passing between rim surface 534 and peripheral rim 514. Interior 528 is depicted as being free of fluid 565; interior 528 will contain distally directed fluid during distal advancement of the fluid contents of the device. The fluid-tight seal between edge surface 534 and rim 514 - along with the fluid-tight seals between convex surface 546 and concave surface 538 and between convex surface 536 and concave surface 548; and the fluid-tight seals between inner wall 506 and both (truncated) conical surface 531 and insert element 522a - restricts distally directed fluid reaching filter 510 from flowing (and being filtered) through filter 510, through channel 533, past end protrusion 537 and onto distal outlet 504 for delivery (and any previous pre-delivery syringe preparation steps).

[0186] Figure 6 Will provide Figure 5 6-6, which is shown parallel to and distal to the filter 510.

[0187] Figure 6 Details of device features are shown that may have similarities to those of delivery devices 100 and 200 ( Figure 1 and Figure 2 The same relationship, property and function of one or both of the features shown separately and / or Figure 3 、 Figure 4 and / or Figure 5 6, as indicated by the same reference numerals as described above. These device features may include container 602, inner wall 606; cylindrical body 624, inner wall 629; and filter base 630, central protrusion 632, channel 633, edge surface 634 and edge 635.

[0188] Figure 6 The outer circumferential feature of the edge 635 is depicted immediately along the inner wall 629. The edge 635 can be configured to press against the inner wall 629, thereby providing a fluid-tight seal that prevents fluid from passing between the filter base 630 and the inner wall 629. The fluid-tight seal between the filter base 630 and the inner wall 629 can help limit the path of distally displaced fluid toward the channel 633 (as described above). Figure 5 (as discussed in the description of ).

[0189] Figure 7 An exemplary drug delivery device 700 is shown. The delivery device 700 may have one or more device features that are similar to those of the delivery devices 100 and 200 ( Figure 1 and Figure 2 The same relationship, property and function of one or both of the features shown separately and / or Figure 3 、 Figure 4 、 Figure 5 and / or Figure 6 706; filter 710, central region 712; cylindrical body 724, interior 728, inner wall 729; filter base 730, central protrusion 732, channel 733, end protrusion 737; filter cap 740, stopper 741, collar 742, groove 743a, groove protrusion 743b, inwardly protruding edge 744, distal side 745; and fluid 765 and plunger 766.

[0190] Figure 7 The device 700 is depicted in an operational configuration after the stopper 741 has been displaced from the collar 742. This configuration can be considered a filtering configuration. To achieve the depicted configuration, the user has begun to advance the plunger 766 within the container 702 toward the distal outlet 704, thereby achieving an increase in pressure within the fluid 765. The increase in fluid pressure has exerted a distally directed force on the proximal exterior of the stopper 741, which is then maintained within the collar 742 (as shown) by the contact / friction forces of the inwardly projecting edge 744 and the interference of the groove 743a (with its groove protrusion 743b). Figure 4 shown). (See Figure 4 Interfering device details.) A further increase in fluid pressure applied by the user via plunger 766 then results in a distally directed force of sufficient magnitude to overcome the interfering contact / friction forces, thereby displacing stopper 741 distally from collar 742.

[0191] In order to achieve Figure 7 In the depicted filter configuration, after plug 741 is distally displaced from collar 742, plug 741 has already conveyed interior 728 toward filter 710. Plug 741 is driven toward filter 710 by distally directed fluid 765, which is propelled by a plunger 766 that is displaced distally by a user relative to inner wall 706. Distal face 745 of plug 741 is displaced distally to be positioned proximal to central region 712 of filter 710. As plunger 766 continues to be displaced distally, fluid continues to flow through unobstructed collar 742 into interior 728; between inner wall 729 and the longitudinally outer portion of plug 741; along and distally away from face 745; and from there forced through filter 710.

[0192] Figure 7Filtered fluid 767 (illustratively depicted as a spot) is shown having emerged from filter 710 and disposed distally of the filter. Filtered fluid 767 may be the filtrate of fluid 765. Filtered fluid 767 may have a different content than fluid 765. Fluid 765 may contain particulate matter of a size that is retained by filter 710 as fluid 765 is advanced distally onto and into filter 710. Fluid 767 may be free of the particulate matter of fluid 765 retained by filter 710. The size of the particulate matter in fluid 765 that is retained by filter 710 may depend on the pore size of filter 710. The pore size of filter 710 may be the average effective pore size. (As discussed above, the use of specialty filters in the present invention can extend the range of distinction between the filtrate and the pre-filtered PFS fluid content beyond the size of dissolved / suspended particles, thereby broadening the range of charge distribution and / or molecular characteristics.)

[0193] As shown, filtered fluid 767 can fill channel 733; extend through end protrusion 737 to fill distal outlet 704; and from there be directed for delivery of filtered fluid 767 (as well as for any previous pre-delivery syringe preparation steps). As more fluid 765 is advanced onto and into filter 710 by the user displacing plunger 766 further distally from the depicted position of plunger 766, new filtered fluid 767 can continue to flow distally from filter 710, through channel 733 to distal outlet 704, and then toward delivery.

[0194] Figure 8 Will provide Figure 7 8 is a view of the device taken proximally along line 8-8, which is shown parallel to and proximal to the filter 710.

[0195] Figure 8 Details of device features are shown that may have similarities to those of delivery devices 100, 200, and 700 ( Figure 1 、 Figure 2 and Figure 7 The same relationship, property and function of one or more of the features shown separately and / or Figure 3 、 Figure 4 、 Figure 5 and / or Figure 6 806; cylindrical body 824; interior 828; interior wall 829; plug 841; distal side 845; tab 847; inter-tab gap 849; and fluid 865.

[0196] Figure 8Plug 841 is depicted as being at least approximately centered within inner wall 829 of cylindrical body 824. The centering of plug 841 within inner wall 829 can result from approximately equal amounts of distally propelled fluid 865 passing along the longitudinal sides of plug 841. The area of ​​interior 828 disposed between inner wall 829 and inter-tab gap 849 can provide a greater passageway for fluid 865 than the area disposed between inner wall 829 and tab 847. The geometries of plug 841, tab 847, inter-tab gap 849, and inner wall 829 can be preselected to achieve a desired flow rate for fluid 865.

[0197] Figure 8 A fluid 865 is shown disposed across the distal side 845. The fluid 865 flows along and away from the distal side (away from the distal side). Figure 8 (The distal side 845 of the FIGURE 845 is a diagram of a page, toward the viewer) that intermittently moves the plug 841 relative to the filter (not shown). The intermittent movement of the plug 841 relative to the filter helps dynamically change the thickness of the fluid 865 between the filter and the distal side 845. Dynamically changing the thickness of the fluid 865 between the filter and the distal side 845 can reduce the accumulation of particles on the proximal side of the filter. Reducing the accumulation of particles on the proximal side of the filter can help maintain the filtration efficiency of the filter. The thickness of the fluid 865 between the filter and the distal side 845 can serve to cushion the filter from direct contact with the distal side 845.

[0198] The passage of fluid 865 along and distally away from the distal surface 845 can intermittently move the plug 841 relative to the inner wall 829. The intermittent movement of the plug 841 relative to the wall 829 can cause the tab 847 to intermittently interfere with the wall 829. The intermittent interference of the tab 847 with the wall 829 can help maintain the oscillatory motion of the cylindrical axis (not shown) of the plug 841 approximately colinear with the longitudinal axis L. Maintaining the colinearity of the cylindrical axis of the plug 841 with the axis L can prevent the plug 841 from becoming skewed relative to the inner wall 829 and / or from becoming wedged between the sides of the inner wall.

[0199] Preventing the plug 841 from tilting relative to the sides of the inner wall 829 and / or becoming wedged between the inner sides is also a consideration as the plug 841 is transported distally within the interior 828 after it is displaced distally from within the collar (not shown) of the cylindrical body 824, as shown in FIG. Figure 4 When the plug 841 is released from the collar, the functional effect of the tab 847 can begin immediately at the beginning of distal transport of the plug 841 into the interior 828, before there is substantial flow of fluid 865 along the longitudinal exterior of the plug 841. The interference of the tab 847 with the inner wall 829 can be used to brake the distal advancement of the plug 841 at the first moment of its distal advancement into the interior 828.

[0200] Figure 9An exemplary drug delivery device 900 is shown. The delivery device 900 may have one or more device features that are similar to those of the delivery devices 100, 200, and 700 ( Figure 1 、 Figure 2 and Figure 7 The same relationship, property and function of one or more of the features shown separately and / or Figure 3 、 Figure 4 、 Figure 5 、 Figure 6 and / or Figure 8 906; filter housing 920; filter base 930; and fluid 965, plunger 966, and plunger rod 968.

[0201] The device 900 is shown in a pre-filtration operating configuration, wherein the distal hollow section of the filter base 930 and the distal outlet 904 are depicted as being free of fluid.

[0202] The filter housing 920 may include a filter base 930 and a filter cover 940. Similar to the filter cover previously shown and discussed, the filter cover 940 may be configured to block fluid from entering the filter (not shown) in the pre-filtration operating configuration of the device 900; and to allow fluid to enter the filter in the filtering operating configuration of the device 900. The filter cover 940 may be similar in structure and mode of operation to the filter cover previously described in FIG. Figures 2 to 8 The filter cover shown and / or discussed in is different.

[0203] Previously Figures 2 to 8 The filter covers shown in and / or discussed with reference thereto may be considered to be displaceable plug filter covers. Filter cover 940 may not be a displaceable plug filter cover. Filter cover 940 may be considered to be an openable disc filter cover. As a category, openable disc filter covers may include ruptured disc filter covers. The differences in structure and mode of operation between openable disc filter covers and displaceable plug filter covers will be discussed in detail. Figures 10 to 14 shown and / or discussed in.

[0204] Figure 10 Details of device features are shown that may have similarities to those of delivery devices 100, 200, 700, and 900 ( Figure 1 、 Figure 2 、 Figure 7 and Figure 9 The features of one or more of the components (shown separately) have the same relationship, nature and function and / or are Figure 3 、 Figure 4 、 Figure 5 、 Figure 6and / or Figure 8 1034, and a proximal edge 1035. These device features may include filter 1010, central region 1012, peripheral edge 1014; filter housing 1020, insert elements 1022a and 1022b (collectively, insert elements 1022), hollow cylindrical body 1024, distal edge 1026; filter base 1030, proximal central protrusion 1032, proximal edge surface 1034, proximal edge 1035, circumferential convex surface 1036, and circumferential concave surface 1038; and filter cap 1040.

[0205] Figure 10 The exploded view of FIG. 1 depicts the filter base 1030 and the filter cover 1040 separated from each other, with the filter 1010 spaced therebetween. Figure 10 Provides an unobstructed view of features of the filter housing 1020 that are visible when the filter housing 1020 is assembled (such as Figure 9 This may be more difficult to discern in the view of the filter housing 220 shown.

[0206] The convex surface 1036 and / or the concave surface 1038 can be configured to mechanically interfere with distal internal features (not shown) of the filter cover 1040. The distal internal features of the cover 1040 can have similar properties to those of the delivery devices 200 and 700 ( Figure 1 and Figure 2 The same relationship, property and function of one or both of the features shown separately and / or Figure 4 、 Figure 5 、 Figure 6 、 Figure 7 and / or Figure 8 Shown in.

[0207] The interference of the convex surface 1036 and / or the concave surface 1038 with the distal interior features of the filter cover 1040 can assemble the filter base 1030 and the filter cover 1040. The interference of the convex surface 1036 and / or the concave surface 1038 with the distal interior features of the filter cover 1040 can secure the filter base 1030 and the filter cover 1040 together.

[0208] The convex surface 1036 and / or the concave surface 1038 can be configured to press against a distal interior feature of the filter cover 1040. Pressing the convex surface 1036 and / or the concave surface 1038 against the distal interior feature of the filter cover 1040 can provide a fluid-tight seal between the filter base 1030 and the filter cover 1040. The distal interior feature of the filter cover 1040 can be configured to press against the convex surface 1036 and / or the concave surface 1038. Pressing the distal interior feature of the filter cover 1040 against the convex surface 1036 and / or the concave surface 1038 can provide a fluid-tight seal between the filter base 1030 and the filter cover 1040.

[0209] The distal edge 1026 can be configured to receive at least a portion of the filter base 1030. The distal edge 1026 can be configured to longitudinally receive the filter 1010 and the proximal edge 1035.

[0210] As shown, insert element 1022b may be placed along the circumferential exterior of cylindrical body 1024. Insert element 1022b may extend along the entire circumference of the circumferential exterior of cylindrical body 1024. Insert element 1022b may not extend along the entire circumference of the circumferential exterior of cylindrical body 1024.

[0211] Insert element 1022 can be pressed against an inner container wall (not shown) of the device. Pressing insert element 1022 against the inner container wall can provide a fluid-tight seal against the passage of fluid between insert element 1022 and the inner container wall.

[0212] The filter cover 1040 can define a cylindrical axis (not shown). The cylindrical axis can be centered relative to the circumference of the circumferential outer portion of the cylindrical body 1024. The cylindrical axis can be disposed parallel to the longitudinal outer portion of the cylindrical body 1024. The cylindrical axis can be parallel to the cylindrical inner wall (not shown) of the cylindrical body 1024 and centered relative to the cylindrical inner wall (not shown). The cylindrical axis can be centered relative to the circumference of the distal edge 1026. The cylindrical axis can intersect the center of the circumference of the diaphragm 1054. The cylindrical axis can be disposed at least approximately coaxially with the longitudinal axis of the device (not shown).

[0213] The structural differences between filter cover 1040 and a displaceable plug-type filter cover can be found in the proximal portion of filter cover 1040. The proximal portion of filter cover 1040 can include a diaphragm ring support 1052. Ring support 1052 can be located along the proximal outer edge of filter cover 1040. Ring support 1052 can be located along the entire proximal outer edge. Ring support 1052 can be located within the proximal outer edge. Ring support 1052 can be located within the inner circumference of the proximal outer edge. Ring support 1052 can span the entire inner circumference of the proximal outer edge. Ring support 1052 can be integral with the proximal outer edge. The proximal outer edge can support ring support 1052.

[0214] The ring support 1052 may support a diaphragm 1054. The diaphragm 1054 may be integral with the inner circumference of the ring support 1052. The diaphragm 1054 may span the entire inner circumference of the ring support 1052. The diaphragm 1054 may completely occupy an area concentric with the inner circumference of the ring support 1052.

[0215] The diaphragm 1054 may include a diaphragm slit 1055. The cylindrical axis of the cylindrical body 1024 may intersect the slit 1055. The cylindrical axis may run through the midpoint of the length of the slit 1055. The slit 1055 may include a plurality of slits.

[0216] The slits 1055 may extend across the area of ​​the diaphragm 1054 along a secant line of the diaphragm 1054. The slits 1055 may extend across the area of ​​the diaphragm 1054 along a diameter of the diaphragm 1054. The slits 1055 may be positioned along the diameter of the diaphragm 1054. The slits 1055 may be positioned along the entire diameter of the diaphragm 1054. The slits 1055 may be positioned along a portion of the diameter of the diaphragm 1054.

[0217] The slit 1055 may extend across the entire depth of the full thickness of the diaphragm 1054. The slit 1055 may extend across a portion of the depth of the full thickness of the diaphragm 1054. The slit 1055 may extend from the proximal side of the diaphragm 1054 into the diaphragm 1054, distally across a portion of the depth of the full thickness of the diaphragm 1054. The slit 1055 may extend from the distal side (not shown) of the diaphragm 1054 into the diaphragm 1054, proximally across a portion of the depth of the full thickness of the diaphragm 1054.

[0218] The membrane 1054 can be configured in a pre-filtration configuration to prevent the PFS fluid from flowing to the filter 1010. The membrane 1054 can be configured to unseal when transitioning from the pre-filtration configuration to the filtering configuration by directing the PFS fluid distally against the proximal side of the membrane 1054. The membrane 1054 can be configured to provide a passage for the PFS fluid contents to flow through the unsealed membrane 1054 to the filter 1010 in the filtering configuration.

[0219] Figure 11 Will provide Figure 9 A partial cross-sectional view of the distal portion of the device.

[0220] Figure 11 Details of device features are shown that may have similarities to those of delivery devices 100, 200, 700, and 900 ( Figure 1 、 Figure 2 、 Figure 7 and Figure 9 The features of one or more of the components (shown separately) have the same relationship, nature and function and / or are Figure 3 、 Figure 4 、 Figure 5 、 Figure 6 、 Figure 8 and / or Figure 10As shown in FIG, as described above, as indicated by the same reference numerals. These device features may include a container 1102, a distal outlet 1104, an inner wall 1106; a filter 1110, a central area 1112, a periphery 1114; a filter housing 1120, an insert element 1122 (insert element 1122a and insert element 1122b), a cylindrical body 1124, a distal edge 1126, an interior 1128; a filter base 1130, a (truncated) conical surface 1131, a central protrusion 1132, a channel 1133, an edge surface 1134, an edge 1135, a filter base convex surface 1136, an end protrusion 1137, a filter base concave surface 1138; a filter cover 1140, a filter cover convex surface 1146, a filter cover concave surface 1148; a diaphragm ring support 1152, a diaphragm 1154, a diaphragm slit 1155; and a fluid 1165.

[0221] exist Figure 11 In the depicted pre-filtration operating configuration, interior 1128 of cylindrical body 1124, passage 1133, and distal outlet 1104 are shown devoid of fluid 1165. Slit 1155 can be closed to block fluid 1165 from flowing through membrane 1154, preventing fluid 1165 from flowing distally into interior 1128 and distally outwardly toward filter 1110.

[0222] The diaphragm 1154 may include diaphragm petals. The diaphragm petals may include diaphragm petals 1158a. The diaphragm petals may include diaphragm petals 1158b. The diaphragm petals may seal against each other at the slits 1155. The diaphragm petals may seal against each other at the slits 1155.

[0223] The diaphragm petals closing and / or sealing relative to each diaphragm petal can provide a fluid-tight seal, preventing fluid 1165 from being displaced distally into interior 1128. An increase in fluid pressure applied by a user upon initiating a transition to the filtering operating configuration of the delivery device can achieve a pressure within fluid 1165 sufficient to overcome the force closing and / or sealing slit 1155 to prevent distal fluid displacement through diaphragm 1154. Diaphragm 1154 can be opened at slit 1155 by pressure applied by the user. Diaphragm 1154 can be ruptured at slit 1155 by pressure applied by the user.

[0224] In a filtering configuration (not shown) achieved by opening / rupturing the slits 1155 by increasing the pressure applied by the user within the fluid 1165, the fluid propelled distally can flow into the interior 1158. The fluid propelled distally can drive the flaps 1158a and / or flaps 1158b to fold onto the cylindrical body 1124. The folded flaps 1158a and / or flaps 1158b can extend into the interior 1128. The folded flaps 1158a and / or flaps 1158b can extend into the interior 1128 at an acute angle from the illustrated position of the flaps. The folded flaps 1158a and / or flaps 1158b can extend into the interior 1128 at least approximately perpendicularly from the illustrated position of the flaps. The folded flaps 1158a and / or flaps 1158b can extend into the interior 1128 at an obtuse angle from the illustrated position of the flaps.

[0225] The flap 1158a and / or the flap 1158b may be folded at the hinge element 1156. The hinge element 1156 may be supported by the ring support 1152. The hinge element 1156 may include an area surrounded by a circumference along the distal side of the diaphragm 1154. The area surrounded by the circumference of the distal side of the diaphragm 1154 may include a groove extending proximally into the material of the diaphragm 1154. The corresponding area along the proximal side of the diaphragm 1154 may include a groove extending distally (not shown) into the material of the diaphragm 1154. The groove extending into the diaphragm material may be arranged along a line segment surrounded by the support ring 1152. The groove extending into the diaphragm material may be arranged along an arc concentric with the cylindrical body 1124. The material of the diaphragm 1154 arranged along the groove may be easier to fold than the material of the diaphragm 1154 arranged away from the groove.

[0226] Figure 12 The diagram will be provided taken from the proximal side along line 12-12 Figure 11 In view of the device, the line is shown as running through the interior 1128, the line being arranged parallel to the filter 1110 and proximal to the filter.

[0227] Figure 12 Details of device features are shown that may have similarities to those of delivery devices 100, 200, 700, and 900 ( Figure 1 、 Figure 2 、 Figure 7 and Figure 9 The features of one or more of the components (shown separately) have the same relationship, nature and function and / or are Figure 3 、 Figure 4 、 Figure 5 、 Figure 6 、 Figure 8 、 Figure 10 and / or Figure 1112. The apparatus features shown in FIG. 12 may include a container 1202, an inner wall 1206, an insert element 1222b, a cylindrical body 1224, a filter cover 1240, a diaphragm ring support 1252, a diaphragm 1254, a diaphragm slit 1255, a diaphragm hinge element 1256, and diaphragm petals 1258a and 1258b.

[0228] The insert element 1222b can be pressed against the inner wall 1206. The insert element 1222b pressed against the inner wall 1206 can help install the filter cover 1240 within the container 1202. The insert element 1222b pressed against the inner wall 1206 can help secure the filter cover 1240 on the cylindrical axis of the cylindrical body that is at least approximately coaxial with the device axis (neither shown).

[0229] Insert element 1222b pressed against inner wall 1206 may facilitate sealing of insert element 1222b against inner wall 1206. The sealing of insert element 1222b against inner wall 1206 may provide a method of preventing PFS fluid contents (not shown) from being transferred distally (ie, out of) the inner wall 1206. Figure 12 page, toward the viewer) through a fluid-tight seal between the embedded element 1222b and the inner wall 1206.

[0230] exist Figure 12 In the depicted pre-filtration operating configuration, the distal side of the membrane 1254 is shown. The distal side of the membrane 1254 can be the side of the membrane 1254 that faces the interior of the cylindrical body 1224 (e.g., Figure 11 1254 ). The opposing edges of the petals 1258a and 1258b can be enclosed and / or sealed to each other along the slit 1255 to provide a fluid-tight seal for the diaphragm 1254 and prevent the PFS fluid contents from passing distally through the diaphragm 1254 and into the cylindrical body 1224.

[0231] Figure 13 Will provide Figure 12 A view of the device that is Figure 12 The cut view is the same, but taken at the beginning of the filtering operation configuration, where the distally advancing PFS fluid contents just open / rupture the membrane.

[0232] Figure 13 Details of device features are shown that may have similarities to those of delivery devices 100, 200, 700, and 900 ( Figure 1 、 Figure 2 、 Figure 7 and Figure 9 The features of one or more of the components (shown separately) have the same relationship, nature and function and / or are Figure 3 、 Figure 4 、 Figure 5 、 Figure 6 、 Figure 8 、 Figure 10 、 Figure 11 and / or Figure 12 1365. The apparatus features shown in FIG. 1366 are shown in FIG. 1367, as indicated by the same reference numerals as described above. These apparatus features may include a container 1302, an inner wall 1306; a cylindrical body 1324 with an insert element 1322b; a filter cap 1340; a diaphragm ring support 1352, a diaphragm 1354, a diaphragm slit 1355, a diaphragm hinge element 1356, and diaphragm petals 1358a and 1358b; and a fluid 1365.

[0233] Figure 13 1354. The embodiment depicts an early stage of the filtration operation configuration, wherein fluid 1365, being advanced distally within container 1302 against the exterior surface (not shown) of diaphragm 1354, may have gained sufficient pressure to open / rupture diaphragm slit 1355. As diaphragm slit 1355 opens / ruptures in response to pressure, fluid 1365 is depicted as beginning to enter the space between opposing edges of flap 1358a and flap 1358b. Flaps 1358a and 1358b may flex away from one another. Flaps 1358a and 1358b may begin to fold distally into cylinder 1324. Flaps 1358a and 1358b may begin to fold along hinge element 1356. Hinge element 1356 may be supported by ring support 1352.

[0234] Diaphragm 1354 can be configured such that if the distal propulsion force of fluid 1365 decreases below the force required to generate sufficient pressure to open / rupture slit 1355, the opposing edges of flaps 1358a, 1358b approach each other and reclose against each other, sealing the slit. Diaphragm 1354 can be configured to remain open / ruptured even after the slit is opened / ruptured if the distal propulsion force of fluid 1365 decreases below the force required to generate sufficient pressure to open / rupture slit 1355. Diaphragm 1354 can be configured such that, prior to a specific preselected stage of slit 1355 opening and flaps 1358a and 1358b folding distally into cylinder 1324, diaphragm 1354 will reclose upon reduction of fluid pressure. The diaphragm 1354 can be configured such that after a certain preselected stage of opening of the slit 1355 and folding of the flaps 1358a and 1358b distally into the cylinder 1324, the diaphragm 1354 will not reseal even when the fluid pressure is reduced.

[0235] Figure 14 An exemplary drug delivery device 1400 is shown. The delivery device 1400 may have one or more device features that are similar to those of the delivery devices 100, 200, 700, and 900 ( Figure 1 、 Figure 2 、 Figure 7 and Figure 9The features of one or more of the components (shown separately) have the same relationship, nature and function and / or are Figure 3 、 Figure 4 、 Figure 5 、 Figure 6 、 Figure 8 、 Figure 10 、 Figure 11 、 Figure 12 and / or Figure 13 1465, plunger 1466, and fluid 1467.

[0236] Figure 14 Depicts the slit in the diaphragm ( Figure 13 (shown) Device 1400 in an operational filtering configuration after a user has opened / ruptured the membrane 1454 by advancing plunger 1466 distally within container 1402 toward outlet 1404, generating pressure within fluid 1465 sufficient to open / rupture the membrane 1454. (For movement from the pre-filtration configuration to the filtering configuration, compare Figure 12 and Figure 13 . )

[0237] In order to achieve Figure 14 In the depicted filter configuration, after the membrane 1454 is opened / ruptured, the user continues to displace the plunger 1466 distally, forcing fluid 1465 to flow through the opened / ruptured membrane 1454 into the interior 1428; between the distally folded membrane flaps 1458a and 1458b; and to the proximal side of the filter 1410. The proximal protrusion 1432 provides support to the central region 1412, supporting the filter 1410 against the force suddenly applied to the filter 1410 by the distally pushed fluid 1465 that first encounters the proximal side of the filter 1410. As the distally pushed fluid 1465 continues to encounter the proximal side of the filter 1410, the fluid 1465 is forced through the filter 1410 and is filtered by the filter.

[0238] Figure 14Filtered fluid 1467 is shown emerging from filter 1410 and disposed distally of the filter. Filtered fluid 1467 may be the filtrate of fluid 1465. Filtered fluid 1467 may have a different content than fluid 1465. Fluid 1465 may contain particulate matter of a size that is retained by filter 1410 as fluid 1465 is advanced distally onto and into filter 1410. Fluid 1467 may be free of the particulate matter of fluid 1465 retained by filter 1410. The size of the particulate matter in fluid 1465 that is retained by filter 1410 may depend on the pore size of filter 1410. The pore size of filter 1410 may be the average effective pore size. (As discussed above, the use of specialty filters in the present invention can extend the range of differentiation between the filtrate and the pre-filtered PFS fluid content beyond the size of dissolved / suspended particles, thereby broadening the range of charge distribution and / or molecular characteristics.)

[0239] Diaphragm flaps 1458a and 1458b are depicted as having been folded into interior 1428, with their distal ends (which, prior to opening / rupturing of diaphragm 1410, were already the flap edges facing each other across the diaphragm slit and had already closed / sealed the diaphragm slit) facing toward and proximal to the proximal surface of filter 1410. Folding of diaphragm flaps 1458a and 1458b occurs at diaphragm hinge element 1456, which is supported by diaphragm ring support 1452. Filtration of fluid 1465 to produce fluid 1467 can also be achieved by less extreme folding of diaphragm flaps 1458a and 1458b than depicted in the depiction of diaphragm flaps 1458a and 1458b entering interior 1428.

[0240] As shown, filtered fluid 1467 can fill channel 1433; extend through end protrusion 1437 to fill distal outlet 1404; and be directed therefrom for delivery of filtered fluid 1467 (as well as for any previous pre-delivery syringe preparation steps). As more fluid 1465 is advanced onto and into filter 1410 by the user displacing plunger 1466 further distally from the depicted position of plunger 1466, new filtered fluid 1467 can continue to flow distally from filter 1410, through channel 1433 to distal outlet 1404, and then toward delivery.

[0241] After distally pushed fluid 1465 ceases to flow through interior 1428 to filter 1410, membrane petals 1458a and 1458b can deploy rearwardly toward the position they occupied in the pre-filtration configuration (such as Figure 11 and 12). The extent of this expansion can be set by preselecting the materials, structures, and geometries of the diaphragm 1454, the diaphragm flaps 1458a and 1458b, the diaphragm ring support 1452, and the diaphragm hinge element 1456. This expansion can reseal the diaphragm 1454.

[0242] Thus, apparatus and methods have been provided for filtering the fluid contents of a PFS immediately prior to drug delivery in a manner that maintains the advantages of PFS use while isolating the filter from the fluid until delivery begins, including methods of manufacture. Those skilled in the art will appreciate that the present invention may be practiced in ways other than the described embodiments, which are presented for purposes of illustration and not limitation. The present invention is limited solely by the appended claims.

Claims

1. A fluid delivery device for delivering a filtered fluid from a distal outlet of the device, the device defining a longitudinal axis and comprising: a fluid within a fluid container, said container being disposed coaxially with said longitudinal axis; as well as A filter is embedded in the container, the filter being provided with: between the distal outlet and the fluid; and across the longitudinal axis.

2. The delivery device of claim 1, further comprising a filter housing comprising a proximal filter cover and a distal filter base.

3. The delivery device according to claim 2, wherein: The filter is secured in the filter housing; and The filter housing is fixed in the container.

4. The delivery device of claim 2, wherein the filter base is configured to provide distal support to the filter.

5. The delivery device of claim 4, wherein the distal support is provided to a central region of the filter by a proximal central protrusion of the filter base. The delivery device of claim 5 , wherein the filter is not attached to the proximal central protrusion.

7. The delivery device of claim 2, wherein a perimeter of the filter is attached to a proximal surface of the filter base.

8. A delivery device according to claim 2, wherein the area of ​​the filter that circumferentially borders the filter periphery is joined to the proximal surface of the filter base with a fluid-tight seal, the seal being configured to prevent the passage of fluid between the interior of the filter base and any filter periphery of the filter periphery.

9. The delivery device of claim 2, wherein the filter base is secured to the filter cover.

10. The delivery device of claim 2, wherein interference between at least one filter cover convex surface and at least one filter base concave surface is configured to secure the filter cover to the filter base.

11. The delivery device of claim 10, wherein the at least one filter base concave surface and the at least one filter cover convex surface are at least generally complementary in profile to one another.

12. The delivery device according to claim 10, wherein: The at least one filter cover convex surface is disposed along a portion of an interior surface of the filter cover; and The at least one filter base concave surface is disposed along a portion of an exterior surface of the filter base.

13. The delivery device of claim 2, wherein interference between the at least one convex filter cover surface and the at least one concave filter base surface is configured to provide a fluid-tight seal.

14. The delivery device of claim 2, wherein interference between the at least one concave filter cover surface and the at least one convex filter base surface is configured to provide a fluid-tight seal.

15. The delivery device of claim 2, wherein the filter housing wall is configured to seal against an inner wall of the container, thereby preventing the fluid from passing between an exterior of the filter housing and the inner wall.

16. The delivery device of claim 15, wherein the wall comprises a filter cover sealing flange disposed along an outer periphery of the filter cover.

17. The delivery device of claim 16, wherein the filter cover sealing flange comprises a plurality of filter cover sealing flanges.

18. The delivery device of claim 15, wherein the wall comprises a filter base sealing surface supported by a distal section of a body of the filter base.

19. The delivery device of claim 1, wherein the filter has an average pore size of about 1 micron to about 10 microns.

20. The delivery device of claim 19, wherein the average pore size is from about 4 microns to about 6 microns.

21. The delivery device of claim 1, wherein the filter has an average pore size of about 0.01 microns to about 1 micron.

22. The delivery device of claim 21, wherein the average pore size is from about 0.1 microns to about 0.3 microns.

23. The device of claim 1, further comprising a filter housing configured to: preventing the fluid from contacting the filter prior to propelling the fluid toward the distal outlet; and The fluid is allowed to contact the filter after initiating the advancing.

24. The delivery device of claim 1, further comprising: A slidable plunger proximal to the fluid, the plunger being configured to: sealing the fluid within the container; as well as advancing the fluid toward the distal outlet; as well as, a filter cap configured to block fluid from entering said filter prior to said delivering; The fluid is configured to unblock the cap when advanced by the plunger to allow the fluid to flow toward the distal outlet.

25. The delivery device of claim 2, wherein the filter cap includes a proximal plug disposed in the collar and sealing the collar to prevent the fluid from flowing to the filter, the plug being configured to: The distally propelled fluid is displaced distally relative to the collar; and, thereby, the collar is unsealed to allow the fluid to flow therethrough.

26. The delivery device of claim 25, wherein the stopper includes a stopper groove extending radially inwardly along an exterior of the stopper.

27. The delivery device of claim 26, wherein the collar includes a collar rim extending radially inwardly along an interior surface of the collar.

28. The delivery device according to claim 27, wherein Prior to said delivery, the stopper seals the collar to prevent flow by interference between the stopper groove and the collar edge.

29. The delivery device of claim 28, wherein the stopper: defining a cylindrical axis disposed at least generally coaxially with the longitudinal axis prior to delivery; and The invention comprises at least one protrusion extending radially outwardly at a distal side of the stopper groove and perpendicular to the cylindrical axis, wherein a gap between the protrusions is arranged along the outer circumference of the stopper.

30. The delivery device of claim 29, wherein: The at least one tab is a plurality of tabs; and The inter-tab gap is provided between circumferentially adjacent opposite side edges of circumferentially adjacent tabs.

31. The delivery device of claim 29, wherein: The at least one tab is one tab; and The inter-lug gap is provided between circumferentially adjacent opposite side edges of the one lug.

32. The delivery device of claim 29, wherein the at least one tab is configured to maintain the orientation of the cylindrical axis at least substantially coaxial with the longitudinal axis after distal displacement of the stopper relative to the collar.

33. The delivery device of claim 29, wherein the filter cap comprises a cylindrical body including the collar disposed at a proximal end of the body.

34. The delivery device of claim 33, wherein the inter-tab gap is configured to allow the fluid to flow between the exterior of the stopper and the interior of the cylindrical body after the stopper is distally displaced relative to the collar into the interior of the cylindrical body.

35. The delivery device of claim 2, wherein the filter cap includes an initially closed membrane that prevents the fluid from flowing to the filter, the membrane being configured to: Opened by distally propelling fluid; and thereby A channel is provided for the fluid to flow.

36. The delivery device of claim 35, wherein the membrane is a slit membrane.

37. The delivery device of claim 36, wherein the slit membrane comprises a single slit.

38. The delivery device of claim 36, wherein the slit membrane comprises a plurality of slits.

39. The delivery device of claim 35, wherein the membrane is configured to reseal after opening.

40. The delivery device of claim 35, wherein the membrane is configured to reseal after flow of the fluid ceases.

41. The delivery device of claim 35, wherein the membrane is configured to reseal after distal advancement of the fluid has ceased.

42. The delivery device of claim 1, wherein the fluid comprises a drug.

43. The delivery device of claim 1, wherein the container comprises a syringe barrel.

44. The delivery device of claim 1, wherein the wall of the container comprises a plastic polymer.

45. A filter housing for embedding within a drug container of a device defining a longitudinal axis, the device for delivering filtered drug from a distal outlet of the device, the filter housing comprising: A filter base configured to support a filter, the filter: Being arranged on the base; and configured to prevent particles larger than a maximum pore size of the filter from passing therethrough; as well as a filter cover configured to engage with the base; The filter housing is configured to be embedded in the container proximal to the distal outlet.

46. ​​The filter housing of claim 45, wherein the filter housing is further configured to provide a seal around a perimeter of the filter, the perimeter when sealed being configured to prevent the drug from passing therearound.

47. The filter housing of claim 45, wherein the exterior of the filter housing is configured to provide a seal against an inner wall of the container, the seal being configured to prevent distal flow of the medicament between the inner wall and the filter housing.

48. The filter housing of claim 45, wherein the filter cover is further configured to: Before delivering the drug, the drug is blocked from entering the filter, and the drug setting: In said container: proximal to the filter; and Distal to the longitudinally slidable plunger, the longitudinally slidable plunger is configured to: sealing against the inner wall of the container; and advancing the drug toward the distal outlet; and in contact with a proximal exterior feature of the cap; and The blockage is released by distal advancement of the medicament over the feature surface, thereby creating a released cap that allows the medicament to flow to the filter.

49. The filter housing of claim 45, wherein the filter comprises an acrylic polymer.

50. The filter housing of claim 45, wherein the filter comprises polyethersulfone.

51. The filter housing of claim 45, wherein the filter comprises polyvinylidene fluoride.

52. The filter housing of claim 45, wherein the filter has an average pore size of about 5 microns.

53. The filter housing of claim 45, wherein the filter has an average pore size of about 0.2 microns.

54. The filter housing of claim 48, wherein the feature surface comprises a proximal plug disposed in and sealing against a collar of the filter cap, the plug being configured to: The drug is displaced distally relative to the collar by the distally advanced drug; and, thereby, the collar is released from its seal to allow the drug to flow therethrough.

55. The filter housing of claim 48, wherein the feature surface comprises an initially closed membrane configured to: Opened by distally advancing drug; and thereby A channel is provided for the flow of the drug.

56. A method of manufacturing a drug delivery device for delivering a filtered drug, the device defining a longitudinal axis, the method comprising: providing a drug container disposed coaxially with the axis, the container having a distal outlet and a proximal opening; Assembling the filter housing, the assembling comprising: providing a filter base configured to support the filter; The filter is arranged on one side of the base; sealing the perimeter of the filter to prevent fluid flow; Engaging the base with a filter cover, the cover comprising: ribs configured to seal against an inner wall of the container; and External feature surface, which is constructed as follows: blocking fluid from entering said filter prior to said delivering; and unblocking to provide fluid access to said filter during said delivering; introducing the filter housing into the container through the proximal opening, wherein the base is disposed distally and the exterior feature is disposed proximally relative to the axis; inserting the filter housing into the container proximal to the distal outlet; sealing the rib against the inner wall; and, Through the proximal opening: transferring the drug to the container; and, Inserting a longitudinally slidable plunger configured to: sealing the drug within the container; and The drug is advanced toward the distal outlet.

57. The method of claim 56, wherein the inserting is performed without advancing the drug distally sufficiently to unblock the external feature.

58. The method of claim 56, wherein the housing includes an interior surface configured to seal around a perimeter of the filter.

59. The method of claim 56, wherein the external feature comprises a proximal plug disposed in and sealing against a collar of the filter cap, the plug being configured to: The drug is displaced distally relative to the collar by the distally advanced drug; and, thereby, the collar is released from its seal to allow the drug to flow therethrough.

60. The method of claim 56, wherein the exterior feature comprises an initially closed slit membrane configured to: Opened by distally advancing drug; and thereby A channel is provided for the flow of the drug.

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