injector and assembly method

专利摘要:
INJECTOR AND ASSEMBLY METHOD. The injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior wall surfaces and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle, with a point only partially disposed across the seal assembly in a storage state, and is disposed across the inner surface of the seal assembly in the reservoir. sterile in a supply state. Furthermore, the injection may include an actuator that is adapted to move the needle from the storage state container to the supply state.
公开号:BR112014008993B1
申请号:R112014008993-0
申请日:2012-10-11
公开日:2021-06-08
发明作者:Francisca Tan-Malecki；Ron Forster；Scott Nunn；Mark D. Holt；Son Tran；Sheldon Moberg
申请人:Amgen Inc；
IPC主号:

专利说明:

Fundamentals of the Invention
[0001] This patent is directed to an injector and a method of assembling the injector and, in particular, to a preloaded injector and a method of assembling the preloaded injector.
[0002] Injectors are used to deliver medical fluids, such as liquid medications, to a patient. In particular, the injector will deliver fluid to the patient through a needle, cannula or catheter that defines a flow path within the patient. Certain injectors have a reservoir that is assembled by the manufacturer already connected to the flow path. However, these reservoirs are normally supplied empty by the manufacturer to the patient or healthcare provider (eg, physician, nurse, health care assistant, etc.), and then the reservoir is filled at the time of use. Alternatively, the injector can be used in combination with a reservoir that is supplied to the patient or healthcare provider pre-filled.
[0003] In both cases, the injector must be prepared before use. For example, if the reservoir is supplied empty, the reservoir must be filled. To do this, a syringe is filled with the medication to be delivered, and then the medication is injected into the reservoir through an inlet port. Prior to injection, the inlet port must be sterilized by wiping the outer surface with an alcohol swab, for example. Likewise, before the pre-charged reservoir is connected to the flow path in the reciprocating injector, the splice connectors must be sterilized by cleaning the surface with an alcohol swab.
[0004] In any case, using the injector requires additional time and material.
[0005] As set out in more detail below, the present disclosure sets forth an improved injector incorporating advantageous alternatives to the conventional devices and methods discussed above. Invention Summary
[0006] According to an aspect of the present disclosure, an injector may include a one-wall container with an interior surface and a seal assembly with an interior surface, the interior wall surfaces and the seal assembly defining a sterile closed reservoir filled with a product of the medicine. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle, with a point only partially disposed across the seal assembly in a storage state, and is disposed across the inner surface of the seal assembly in the reservoir. sterile in a supply state. Furthermore, the injection may include an actuator that is adapted to move the needle from the storage state container to the supply state.
[0007] The wall of the container can be a rigid wall or a flexible wall.
[0008] According to any of the foregoing, the seal assembly may be a flexible unitary wall, having an interior surface that defines the interior surface of the seal assembly. The flexible unitary wall may define a septum disposed across the opening and fixedly connected to the wall of the container. Alternatively, the wall of the container can define a hole, and the flexible unitary wall can define a lid that is movable along the hole. In that case, the wall of the container may define a closed end opposite the lid and an open end, in which the lid is disposed. As a still alternative, the container wall may define a bore having an opening in fluid communication with a first end of the bore, and the unitary flexible wall defines a septum disposed across the opening and fixedly connected to the container wall, the container further comprising a cap which is disposed within a second end of the hole and is movable along the hole.
[0009] As an alternative to the preceding paragraph, the seal assembly may include a flexible wall with an interior surface that defines the interior surface of the seal assembly, and a clean barrier disposed on the outside of the flexible wall to define a closed and clean space between the flexible wall and the clean barrier, the needle point of the container arranged through the clean barrier to the clean space in the storage state. The container wall can define a hole, and the flexible wall and clean barrier each can define a lid that is movable along the hole. In addition, the container may include a vent in fluid communication with the space between the clean barrier and the flexible wall, which vent may be formed in the clean barrier or within the interior wall surface of the container. Furthermore, the container wall may define a closed end opposite the lids and an open end, on which the lids are disposed. Alternatively, the container wall may define a bore with an opening in fluid communication with a first end of the bore, and the flexible wall and clean barrier each may define a septum disposed across the opening, of the container further including a lid which it is disposed within a second end of the hole and is movable along the hole.
[0010] According to any of the foregoing, the fluid delivery system may include a clean flexible tube connected at a first end to the needle of rigid containers and a second end to a clean rigid injection needle received within a clean cover which closes the needle of the clean rigid injection.
[0011] According to any of the foregoing, the actuator can be adapted to move the needle of the container repeatedly between the storage state and the supply state.
[0012] According to any of the foregoing, the actuator can be adapted to delay movement of the container needle from the storage state to the supply state after an input is received.
[0013] According to any of the foregoing, the injector may include a mechanical, electromechanical or electrical input device coupled to the driver.
[0014] According to any of the background, the drug product may include a volume of an erythropoiesis-stimulating agent, a granulocyte colony-stimulating factor, a TNF blocker, a pegylated granulocyte colony-stimulating factor, antibody-specific interleukin receptor, IGF receptor specific antibody (Insulin Growth Factor receptor), TGF specific antibody or PCSK9 specific antibody (Subtilisin/Kexin Type 9 Proprotein Convertase).
[0015] According to another aspect of the present disclosure, an injector method of assembly may include a reservoir for sterile filling a container with a drug product under sterile conditions, the reservoir defined by an interior surface of a wall of the container and the inner surface of a seal assembly. The method may also include inserting a point of a clean, unsheathed rigid container needle, partially through the seal assembly under clean room conditions, following the presentation of the sterile filling reservoir to define a storage state, and by attaching the container needle to a trigger under clean room conditions, the trigger adapted to move the container needle from the storage state to a supply state wherein the container needle is disposed across the inner surface of the seal assembly to the sterile reservoir.
[0016] According to this aspect, the wall of the container can be a rigid wall or a flexible wall. Brief Description of Drawings
[0017] It is believed that the disclosure will be more fully understood from the following description taken in conjunction with the accompanying figures. Some of the figures may have been simplified by omitting selected elements for the sake of a clearer demonstration of the other elements. Such omissions of elements from some figures are not necessarily indicative of the presence or absence of specific elements in any of the exemplary modalities, except as may be explicitly outlined in the corresponding written description. None of the figures are necessarily to scale.
[0018] Fig. 1 is a cross-sectional view of an embodiment of an injector in accordance with the present disclosure, with a rigid container needle, unsheathed, in a storage state where the needle partially penetrates a unitary container wall;
[0019] Fig. 2 is a perspective view of a template used with the injector container of Fig. 1 to control penetration of the flexible unit wall container by the container needle;
[0020] Fig. 3 is a cross-sectional view of the injector of Fig. 1, with the needle of the container in a supply state where the needle penetrates the unitary wall of the container such that it is disposed through an interior surface of the wall. flexible in a sterile reservoir;
[0021] Fig. 4 is a schematic diagram of a manufacturing plant in which the injectors according to the present disclosure can be filled and assembled;
[0022] Fig. 5 is a cross-sectional view of an alternative embodiment of an injector in accordance with the present disclosure, with a rigid container needle, unsheathed, in a storage state where the needle partially penetrates a unitary container wall. ;
[0023] Fig. 6 is a cross-sectional view of a still alternative embodiment of an injector in accordance with the present disclosure, with a rigid container needle, unsheathed, in a storage state where the needle partially penetrates a unitary wall of the container;
[0024] Fig. 7 is a cross-sectional view of an embodiment of an injector in accordance with the present disclosure, with a rigid container needle in a storage state where the needle partially penetrates a clean barrier, but not a flexible wall, of a seal assembly;
[0025] Fig. 8 is a cross-sectional view of an alternative embodiment of an injector in accordance with the present disclosure, with a rigid container needle in a storage state where the needle partially penetrates a clean barrier, but not a flexible wall. , of a sealing assembly;
[0026] Fig. 9 is a cross-sectional view of a variant to the embodiment of Fig. 8 including openings for evacuating a clean space between a flexible wall and an externally clean barrier is arranged as an associated container needle is moved between a state storage and a supply state;
[0027] Fig. 10 is a cross-sectional view of a further variant to the embodiment of Fig. 8 including bypasses for evacuating a clean space between a flexible wall and an externally clean barrier is arranged as a needle of the associated container is moved between a storage state and a supply state;
[0028] Fig. 11 is a cross-sectional view of the container of Fig. 10 in an intermediate state with deviations in fluid communication with a clean space defined between a flexible wall and a clean barrier;
[0029] Fig. 12 is a schematic view of another container assembly and fluid delivery system that can be used to preserve a sterile condition within the container;
[0030] Fig. 13 is a cross-sectional view of an injector according to yet another embodiment of the present disclosure where a sterile condition is maintained in a reservoir until actuation of the fluid supply system;
[0031] Fig. 14 is a cross-sectional view of a variant of the injector illustrated in Fig. 13;
[0032] Fig. 15 is a cross-sectional view of another variant of the injector illustrated in Fig. 13; and
[0033] Fig. 16 is a flowchart illustrating a method of assembling an injector in accordance with the present disclosure. Detailed Description of the Various Modalities
[0034] Although the following text presents a detailed description of different embodiments of the invention, it should be understood that the legal scope of the invention is defined by the words of the claims presented at the end of this patent. Furthermore, it is to be understood that, unless a term is expressly defined in this patent using the phrase "As used herein, the term ' ' is hereby defined to mean..." or a similar phrase, there is none is intended to limit the meaning of this term, expressly or by implication, beyond its simple or common meaning, and this term is not to be construed as being limited in scope based on any statement made in any section of this patent (other than the language of the claims ). To the extent that any term reported in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, this is for the sake of clarity only so as not to confuse the reader, and it is not intended that such term of the claim be limited, by implication or otherwise, to that single meaning. Finally, unless an element of the claim is defined by reporting the word "means" and a function without reporting any structure, the scope of any element of the claim is not intended to be interpreted based on the application of 35 US C § 112, paragraph six.
[0035] The detailed description should be interpreted as exemplary only and does not describe every possible modality of the invention, as describing every possible modality would be impractical, if not impossible. Numerous alternative modalities could be implemented using current technology or technology developed after the filing date of this patent, which would still be within the scope of the claims defining the invention. Then, along these lines, various embodiments according to the present disclosure are illustrated in Figs. 1-3 and 5-15.
[0036] Generally speaking, an injector in accordance with the present disclosure includes a container, a fluid delivery system and an actuator. When reference is made to an injector, which in some cases may refer to a delivery device that ensures that a quantity of the drug product is delivered, it will be understood that this disclosure also covers infusion devices, which in some cases may refer to a delivery device that ensures that a certain delivery rate is achieved. It should also be understood that infuser injector terms may be used interchangeably when referring to modalities in the specification.
[0037] As illustrated in Figs 1-3 and 5-11, the container may include a wall with an interior surface and a seal assembly with an interior surface, the interior wall surfaces and the seal assembly defining a closed sterile reservoir filled with a drug product. In addition, the fluid delivery system illustrated in these embodiments may include a clean, unsheathed, rigid container needle with a point only partially disposed across the seal assembly in a storage state and is disposed across the inner surface of the seal assembly in the sterile reservoir in a supply state. The injector may also include an actuator that is adapted to move the container needle from the storage state to the supply state, which may involve moving the needle relative to the container, or the container relative to the needle, as discussed in more detail below.
[0038] As illustrated in Figs. 1, 3 and 4-6, the seal assembly may be a flexible unitary wall, having an interior surface that defines the interior surface of the seal assembly, and the needle point of the container may be partially eliminated on the unitary wall. Alternatively, as illustrated in Figs. 7-11, the seal assembly may include a flexible wall with an interior surface defining the interior surface of the seal assembly and a clean barrier disposed on the outside of the flexible wall to define a clean, closed space between the flexible wall and the barrier. clean. According to such embodiments, the needle point of the container is disposed across the clean barrier into the clean space in the storage state.
[0039] Alternatives will be discussed in the context of each of the modalities illustrated in this document.
[0040] Referring then to Fig. 1, an injector 100 is illustrated therein. Injector 100 includes a canister 102, a fluid delivery system 104, and an actuator 106.
[0041] Container 102 (which may also be referred to as a cartridge herein) includes a wall 110 with an inner surface 112 and an outer surface 114. While a unitary wall (i.e., one piece) 110 has been illustrated in Fig. 1 defining the interior and exterior surfaces 112, 114, it will be understood that, in accordance with the other embodiments, the wall 110 may include a plurality of layers with different layers defining the interior and exterior surfaces 112, 114.
[0042] In accordance with certain embodiments of the present disclosure, wall 110 is rigid. According to other embodiments the wall 110 may be flexible, whether in accordance with the nature of the material defining the wall, or in accordance with the nature of the wall structure (e.g. a bellows construction). Wall 110 can be made of glass, metal or polymer, for example. In particular, polymer versions can be made from polycarbonate, polypropylene, polyethylene (such as high density polyethylene), polytetrafluoroethylene, cyclic olefin polymer, cyclic olefin copolymer, Zenith Crystal olefin polymer (available from Daikyo Seiko, Ltd., Japan), nylon or engineering resins, for example. As for flexible versions of wall 110, butyl rubber, silicone-based rubber, latex-based rubber, coated rubber, as well as multilayer polymer films, such as polyethylene (such as low-density polyethylene) ) and polypropylene, can be used.
[0043] The wall 110 may have a generally cylindrical shape, which separates a shoulder 120 from the first cylindrical section 122 having a first transverse diameter from a second cylindrical section 124 of transverse diameter second, the first transverse diameter being smaller than the second transverse diameter. Wall 110 may also define two opposing, open ends 126, 128. Wall 110, or more particularly interior surface 112 of wall 110, may also define a hole 130.
[0044] The container 102 may include a flexible unitary wall 140 (which may also be referred to as a seal or septum) having an inner surface 142 and an outer surface 144. The wall 140 may be disposed at the first open end 126 defined by the wall 110 and fixedly attached to wall 110 of container 102 such that there is limited relative movement between wall 140 and wall 110, for example, at the attachment points of wall 140 to wall 110 through open or opening end 126. , inner surfaces 112, 142 of wall 110 and flexible wall 140 may define, at least in part, a closed sterile reservoir 150 which is filled with a drug product 160, described in more detail below. Wall 140 can be made of bromobutyl, chlorobutyl, or chlorobromobutyl rubber, fluoropolymer rubber, natural rubber, silicone-based rubber, silicone, or santoprene, for example.
[0045] Container 102 may also include a cap or piston 170 with inner and outer surfaces 172, 174. The piston 170 may be received at the end defined 128 by wall 110, and may be movable along bore 130 between ends 126 128 of container 102. According to one embodiment, reservoir 150 within which drug product 160 is disposed and can be defined by interior surfaces 112, 142, 172 of walls 110, 140 and piston 170.
[0046] The container 102 can be used in conjunction with the fluid supply system 104, the relevant parts of which are illustrated in Fig. 1. In particular, the fluid supply system 104 may include a clean rigid container needle. , unsheathed 180 with a stitch 182. As illustrated, the stitch 182 is disposed only partially to the flexible wall 140 in a storage state. The penetration of point 182 of needle 180 into wall 140 can be controlled through a number of methods and/or mechanisms. For example, Fig. 2 illustrates a template that can be used in combination with container 102 to control the depth to which point 182 penetrates wall 140.
[0047] The fluid delivery system 104 may also include an injection needle 190 with a point 192. The point 192 of the injection needle 190 may be covered with a needle shield 194 to prevent contact with and contamination of the point 192 The container needle 180 and injection needle 190 may be connected by a cannula or tube 200, which may be a flexible cannula in accordance with certain embodiments of the present disclosure. Needle 190, like needle 180, can be made of stainless steel, for example.
[0048] The Fluid Delivery System 104 can be used in conjunction with the actuator 106 mentioned above and illustrated schematically in Fig. 1. The actuator 106 can be adapted to move the container needle 180 between the storage state illustrated in Fig. 1 and a delivery state illustrated in Fig. 3. In the delivery state, the needle of the container 180 is disposed through the inner surface 142 of the flexible wall 140 in the sterile reservoir 150.
[0049] The movement of the needle 180 between states can occur in a variety of ways. For example, needle 180 may be considered fixed relative to injector housing 100, and container 102 may move relative to needle 180 and the housing. Alternatively, container 102 can be considered fixed relative to the box, and needle 180 can be moved relative to container 102 and the box. It may also be possible for container 102 and needle 180 to move relative to injector housing 100. It will be understood that all such actions can be embraced within the instruction that driver 106 is adapted to move container needle 180 between states of storage and supply.
[0050] Actuator 106 can be mechanical, electromechanical or electrical. For example, the actuator 106 may include a solenoid, a motor-driven lever, a motor with associated gears, etc. It may even be possible to provide a tab or button attached to the container 102 or the needle 180 to allow the user to achieve relative movement between the container 102 and the needle 180 manually. Indeed, container 102 may be received within a tab or button that is flat on the housing when injector 100 is activated to move container 102 relative to (fixed) needle 180.
[0051] The actuator 106 can move the container needle 180 between the storage and supply states by moving the needle 180 from the storage state to the supply state, or by moving the needle 180 from the supply state to the supply state. storage. In fact, the trigger can move container needle 180 between store and supply states repeatedly (that is, multiple times or repetitions). In addition, actuator 106 can move container needle 180 immediately upon receipt of an input or signal (e.g., as generated by flattening or manipulating a button, switch, or other input device, which may be mechanical, electromechanical or electrical in nature, coupled to actuator 106), or may delay movement of the container needle 180 between storage and supply states for some period of time after an input is received. According to a certain embodiment, the actuator 106 can delay the movement of the needle 180 from the storage state to the supply state until after a delay time.
[0052] As mentioned earlier, reservoir 150 is described as sterile, while container needle 180 is described as clean. These terms describe the condition of reservoir 150 or needle 180 as a result of their assembly, under conditions that ensure a specified level of freedom from contamination, where a sterile object or device is understood to have a relatively greater level of freedom from contamination than a clean object or device. By way of non-limitation of the example, the concepts of sterility and cleanliness can be discussed with reference to the scheme of Fig. 4, which the discussion will be recognized applied not only to the embodiment illustrated in Figs. 1 and 3, but all the modalities described in this document.
[0053] Fig. 4 illustrates a fabrication facility 250 and can be used to discuss a fabrication process that is performed within facility 250. Note that facility 250 is divided into a plurality of spaces, 252, 254 , 256, 258, 260, 262, 264, 266, 268, which divisions can be maintained through the use of permanent or semi-permanent walls or other barriers. As will be understood, certain spaces or regions can be divided without barriers or walls, but they can simply be separated at an organizational level instead. Furthermore, it will be recognized that a greater or lesser number of spaces or an alternative arrangement of spaces may be used, such different numbers or arrangements of spaces being readily determinable by one of ordinary skill in the art.
[0054] The components of container 102 (walls 110, 140, and cap/piston 170) would enter fabric 250 through space 252, where the components are sterilized using electronic beam technology, for example. Alternatively, the container components can be sterilized through other currently known ones (eg, treatment with chlorine dioxide or vapor phase hydrogen peroxide) or sterilization procedures later developed as components that go into manufacturing 250 at points of entry 252, 264, 266. Container 102 would then pass to space 254 for filing with the drug product. Space 254 can be used as an aseptic Class 100 cleanroom. The Class 100 cleanroom is one in which the number of particles of size 0.5 μm or greater allowed per cubic foot of air is less than 100. , container 102 and drug product 160 are moved through transfer space 256 (also operated as a Class 100 cleanroom, in which certain embodiments are also aseptic) before being received into storage space 258.
[0055] Containers 102 move from storage space 258 to inspection area 260 (aseptic in certain embodiments), where containers 102 are inspected prior to assembly with fluid delivery system 104, actuator 106 and other injector elements 100. Because the drug product 160 is contained within the sealed container 102 at this point, the inspection area can be used as a Class 10,000 cleanroom. Once inspected, the pre-loaded, sterile container 102 can be passed from the inspection space 260 to mounting space 262.
[0056] Similar to inspection space 260, assembly space 262 can be used as a Class 10,000 aseptic cleanroom. Materials being passed into the cleanroom of spaces 264, 266 may be in a sterile condition, or may be sterilized using electronic beam technology, for example. Within mounting space 262, fluid delivery system 104 is connected to container 102, as surface 144 of septum/wall 140 has been sterilized by rubbing surface 144 with an alcohol swab, for example. Because of the lower degree of cleanliness, the fluid delivery system 104 may be referred to as clean, but not necessarily sterile. However, because container needle 180 does not penetrate through wall 140, reservoir 150 and drug product 160 remain sterile (i.e., at the highest level of cleanliness). The remainder of the injector 100 may also be mounted in this space 262 prior to the passage of the injector 100 into the packaging space 268, with certain aspects of the injector (e.g., the driver 106) potentially being mounted with the container 102, or the delivery system. of fluid 104 prior to assembly of container 102 and fluid delivery system 104.
[0057] It will be recognized that the injector 100 embodiment illustrated in Figs. 1 and 3 is simply an exemplary embodiment in accordance with the present disclosure. To this end, Figs. 5 and 6 illustrate variants of the injector illustrated in Figs. 1 and 3.
[0058] According to the embodiment of Fig. 5, the injector 300 includes a container 302, a fluid delivery device 304 and an actuator 306. Similar to the embodiment of Figs. 1 and 3, container 302 includes a wall 310 with inner and outer surfaces 312, 314. In addition, wall 310 may have two counter ends 320, 322 with inner surface 312 of wall 310 defining a hole 324 between the counter ends. 320, 322.
[0059] However, unlike container 102, container 302 has a fixed plug 326 that closes end 320. Furthermore, while container 302 has a flexible unitary wall 330 with inner and outer surfaces 332, 334, the wall 330 is disposed at end 322 of container 302, and thus plays the role of cap/piston 170 on container 102. Consequently, wall 330 is movable along hole 324 between counter ends 320, 322. 312, 332 of walls 310, 330 define a sterile reservoir 340 in which a drug product 350 is disposed.
[0060] According to this embodiment, the fluid delivery device 304 may include a clean, unsheathed, rigid container needle 360 having a stitch 362. The stitch 362 of the needle 360, as well as the stitch 182 of the needle 180, is only partially disposed on the flexible wall 330 in a storage state, with the actuator 306 causing the point 362 to move between the storage state and the supply state in which the point 362 is disposed across the interior surface 332 of the flexible wall 330 in sterile reservoir 340. The needle of container 360 may be in fluid communication with an injection needle 370 having a point 372 covered with a shield 374 through a cannula 380 received within a piston rod 382, for example, which the rod 382 can be used to move cap/piston 330 between ends 320, 322 of container 302.
[0061] Fig. 6 shows a variant closely related to that illustrated in Fig. 5. According to the variant illustrated in Fig. 6, a container has a wall 390 with inner and outer surfaces 392, 394. of the containers discussed above, wall 390 defines a closed end 396 and an open end 398. The container also includes a flexible wall 400, as does wall 330 of the embodiment of Fig. 5, which wall 400 is movable within the container between the open end 398 and the closed end 396. According to this embodiment, a separate structure is not required to close one of the ends 396, 398, because the wall 390 already defines the closed end 396 itself. For that matter, the end end 396 can be resized so that it is radially larger than illustrated in Fig. 6.
[0062] Having therefore discussed a plurality of embodiments wherein a seal assembly includes only a flexible unitary wall, a greater plurality of embodiments will be discussed with reference to Figs. 7-11 wherein the seal assembly includes a plurality of walls and/or seals. This structure may also be referred to as a compartmental seal (or septum with reference to Fig. 7, or a cap with reference to Figs. 8-11).
[0063] Referring first to Fig. 7, an injector 450 includes a canister 452, a fluid delivery system 454 and an actuator 456.
The container 452 includes a wall 460, with an inner surface 462 and an outer surface 464. As with the container of Figs. 1 and 2, wall 110 may have a generally cylindrical shape, with a shoulder separating 470 from the first cylindrical section 472 having a first transverse diameter from a second cylindrical section 474 of transverse diameter and second, the first transverse diameter being smaller than the second transverse diameter. Wall 460 may also define two counters, open ends 476, 478. Wall 460, or more particularly interior surface 462 of wall 460, may also define a hole 480.
[0065] Unlike container 102 of Figs. 1 and 3, container 452 of Fig. 7 has a sealing assembly that includes more than a single wall, unitary wall. The container sealing assembly 452 includes a flexible wall 490 and a clean barrier 492. The flexible wall 490 has an inner surface 494 and an outer surface 496, while the clean barrier 492 has an inner surface 498 and an outer surface 500. interior surfaces 462, 494 of wall 460 and flexible wall 490 defining a closed sterile reservoir 510 filled with a drug product 520. On the other hand, the clean barrier 492 is disposed on the exterior of the flexible wall 490 to define a closed clean space 530 between flexible wall 490 and clean barrier 492. Clean space 530 can be defined by inner surface 462 of wall 460, outer surface 496 of flexible wall 490, and inner surface 498 of clean barrier 492.
[0066] As illustrated the container 452 may also include a cap or piston 540 with inner and outer surfaces 542, 544. The piston 540 may be received at the end 478 defined by wall 460, and may be movable along bore 480 between the ends 476, 478 of container 452. According to one embodiment, reservoir 510 within which medicament product 520 is disposed can be defined by interior surfaces 462, 494, 542 of walls 460, 490 and piston 540.
[0067] The embodiment of Fig. 7 also includes the fluid delivery system 454, comprising a clean, unsheathed, rigid container needle 550 with a point 552 disposed across the clean barrier 492 in the clean space 530 in a storage state, and disposed across inner surface 494 of flexible wall 490 in sterile reservoir 510 in a supply state. In this sense, the container needle 550 only partially penetrates the seal assembly. The fluid delivery system 454 may also include an injection needle 560 with a point 562 covered at least initially, with a needle shield 564 to prevent contact with and contamination of the point 562. injection 560 may be connected by a cannula or tube 570, which may be a flexible cannula in accordance with certain embodiments of the present disclosure.
[0068] As was the case with the embodiment of Figs. 1 and 3, the present disclosure includes a number of variants for the embodiment illustrated in Fig. 7, which variants are illustrated in Figs. 8-11.
[0069] The embodiment of Fig. 8 is similar to the embodiment of Fig. 7 in the way that the embodiment of Fig. 5 was similar to those of Figs. 1 and 3. In particular, the nozzle seal assembly 600 according to the embodiment of Fig. 8 is disposed on a container 602 in place of the lid/piston 540 illustrated in relation to the container 452. 602 includes a wall 604 that defines a hole 606, and a flexible wall 608 and a clean barrier 610 each definition of the cap that is movable along the hole 606. While the container wall 602 does not define the open and closed counter ends in the modality illustrated, such an alternative is possible in accordance with the present disclosure similar to that of Fig. 6.
Figs. 9-11 illustrate variants to the embodiment illustrated in Fig. 8, which variants include additional features to allow the space or region between the flexible wall and the clean barrier to be evacuated or exhausted. These additional features may be referred to as vents, valves or bypasses, but all of these structures allow gases to escape from the space or region between the flexible wall and the clean barrier when an actuator moves the associated container needle from a storage state to a supply status. This is not to suggest that the inner wall and the outer wall of the barrier do not remain separate, for example, with the use of a buffer or buffers, in accordance with other embodiments of the present disclosure. However, the alternatives in Figs. 9-11 illustrate the options for evacuating clean space as for those modalities where the inner and outer wall of the barrier meets.
The container 650 is illustrated in Fig. 9 including a wall 652 and a seal assembly, the assembly including a flexible wall 654 and a clean barrier 656. The flexible wall 654 has an inner surface 658 and an outer surface 660, while the clean barrier 654 has an inner surface 662 and an outer surface 664. An inner surface 668 of wall 652 and 658 of the inner surface of flexible wall 654 defining a closed sterile reservoir 670 filled with a drug product 680. clean barrier 656 is disposed outside flexible wall 654 to define a closed clean space 690 between flexible wall 654 and clean barrier 656. Clean space 690 can be defined by inner surface 668 of wall 652, outer surface 660 of flexible wall 652 and inner surface 662 of clean barrier 656.
[0072] As is also illustrated in Fig. 10, a fluid delivery system 700 including a container needle 702 is used in conjunction with the seal assembly. Container needle 702 is illustrated in the storage state, where container needle 702 is disposed through clean barrier 656 such that a point 704 of needle 702 is disposed in clean space 690. Point 704 will penetrate flexible wall 654 and will hang in reservoir 670 in a supply state, not shown. It will be recognized that needle 702 is not designed to size particularly in extent, as is the case with other embodiments illustrated herein.
[0073] In contrast to the previously discussed embodiments, the container 650 illustrated in Fig. 9 includes at least one vent 710. The openings 710 are in fluid communication with the clean space 690 between the clean barrier 656 and flexible wall 654. 710 are selectively actuated to allow gas trapped between the clean barrier 656 and flexible wall 654 to escape through the openings 710 when the seal assembly is moved between the illustrated storage state and the supply state, where the clean barrier 656 is advanced toward the flexible wall 654 to allow point 704 of container needle 702 to penetrate through wall 654. However, openings 710 may be in a relatively sealed-to-environment condition until actuated, for example, by a change in pressure within clean space 690 .
[0074] As illustrated, the vents 710 are disposed within the clean barrier 656 and extend between the inner surface 662 and the outer surface 664 of the barrier 656. A tab 712 covers the end of the vent 710 near the outer surface 664, and that mode seals the end of the vent 710 until the vent is actuated, preserving the cleanliness of the space 690 between the clean barrier 656 and flexible wall 654. Alternatively, the vents 710 can be arranged, for example, in the wall 652 of the container 650.
[0075] Figs. 10 and 11 illustrate another variant on the system of Fig. 8, wherein a container 720 includes a wall 722 and a seal assembly, the assembly including a flexible wall 724 and a clean barrier 726. The flexible wall 724 has an interior surface 728 and an outer surface 730, while the clean barrier 726 has an inner surface 732 and an outer surface 734. An inner surface 738 of wall 722 and inner surface 728 of flexible wall 724 define a sterile closed reservoir 740 filled with a drug product. 750. On the other hand, clean barrier 726 is disposed outside flexible wall 724 to define a closed clean space 760 between flexible wall 724 and clean barrier 726. Clean space 760 may be defined by interior surface 738 of wall 722 , outer surface 730 of flexible wall 722, and inner surface 732 of clean barrier 726.
[0076] As is also illustrated in Fig. 10, a fluid delivery system 700 including a container needle 772 is used in conjunction with the seal assembly. Container needle 772 is illustrated in the storage state, where container needle 772 is disposed through clean barrier 726 so that a point 774 of needle 772 is disposed in clean space 760. Point 774 will penetrate flexible wall 724 and will hang in reservoir 740 in a supply state, not shown.
[0077] In contrast to the previously discussed modalities, the container 720 illustrated in Fig. 10 includes at least one bypass or vent 780. Bypass 780 is in fluid communication with reservoir 740. Bypass 780 are selectively actuated to allow the gas trapped between the clean barrier 726 and the flexible wall 724 escapes through the bypasses 780 in the reservoir 740 when the seal assembly is moved between the illustrated storage state and the delivery state, where the clean barrier 726 is advanced toward the flexible wall 724 to allow needle point 774 of container 772 to penetrate through wall 724.
[0078] However, the bypasses 780 are not in fluid communication with the clean space 760 until the flexible wall 724 has moved from the storage state shown in Fig. 10 to an intermediate state shown in Fig. 11. As shown in Figs. . 10 and 11, offsets 780 may be defined on interior surface 738 of wall 722, and as illustrated may take the form of a groove/slot 782 formed in wall 722. The groove/slot 782 may have a distal end 784 and an end proximal 786. As will be recognized, until outer surface 730 of flexible wall 724 passes distal end 784 of grooves/grooves 782, reservoir 740 is in a sealed condition with respect to clean space 760. outer surface 730 of flexible wall 724 has passed distal end 784 of grooves/grooves 782, gases trapped between clean barrier 726 and flexible wall 724 can exhaust into reservoir 740. This can facilitate movement of barrier 726 and needle 770 toward the flexible wall 724.
[0079] While all of the aforementioned modalities have focused on one degree or other fluid supply system partially disposed through a seal assembly, there are other alternatives where the container needle is not disposed through the seal assembly, or where the needle of the container is fully disposed through the assembly of the seal. Three such alternatives are illustrated in Figs. 12-14.
[0080] Fig. 12 illustrates an injector 800 with a container 802, a fluid supply system 804 and a actuator 806. Similar to the embodiments illustrated above, the actuator 806 would cause the fluid supply system 804 to be disposed through. an assembly of the seal associated with container 802 in a supply state and thus being in fluid communication with the interior of container 802. However, as mentioned above, in the state storage illustrated in Fig. 12, the supply system of the fluid is not even partially disposed through the seal assembly.
[0081] To this end, the container 802 includes at least one flexible wall 810, which may be in the form of a septum or a cap in accordance with the present disclosure. Flexible wall 810 has an inner surface 812 and an outer surface 814. In addition, the fluid delivery system 804 includes a container needle 816, an injection needle 818, and a flexible conduit 820 connecting the container needle 816 and the injection needle 818. Both the container needle 816 and the injection needle 818 are received within a cap 822, 824 that preserves the cleanliness of the needle 816, 818. The cap 822 may be referred to as a flap, while the cap 824 can be referred to as a shield. Also included is an alcohol swab 826 disposed between flexible wall 810 and flap 822, which wiper 826 can be kept in an airtight condition to maintain alcohol saturation.
[0082] According to the present disclosure, prior to initiating the action of the trigger 806, the wiper 826 is withdrawn between the flexible wall 810 and the cap 822. For example, one end of the wiper 826 may be disposed outside the injector housing 800 to allow the end to be tapped and the wiper 826 to be removed from the nozzle 800. Alternatively, the wiper end 826 can be associated with another aspect of the nozzle 800, such as a cap that covers an adhesive surface of the nozzle 800 that will be attached to the patient, such that when the cap is removed to expose the adhesive surface, the wiper 826 is removed from the injector 800 as well. Removal of the wiper sterilizes surface 814 of wall 810 and counter surface 828 of cap 822. Driver 806 then moves the needle of container 816 through cap 822 and flexible wall 810.
Figs. 13 and 14, further illustrated, embodiments in which the container needle is disposed through the flexible wall (defining the cap or septum) and a valve is used to seal the injection needle reservoir. The valve can also be used to control the flow of drug product from the reservoir into the container. In this way, the valve can be used to measure a quantity of drug product from the reservoir, or delay the flow of drug product until a delay in the elapsed time in relation to receiving an input from an input device (e.g., button or switch), for example.
[0084] As such, Fig. 13 illustrates an injector 850 with a container 852, a fluid delivery system 854 and an actuator 856. The container 852 includes at least one flexible wall 860, which may be in the form of a septum. according to the illustrated modality. Flexible wall 860 has an inner surface 862 and an outer surface 864. In addition, the fluid delivery system 854 includes a container needle 866, an injection needle 868, and a cannula or flexible tube 870 connecting the container needle. 866 and the 868 injection needle. The 868 injection needle can be received within a cover 872 that preserves the cleanliness of the 868 needle.
[0085] On the other hand, the container needle 866 (and in particular a point 874 of the container needle 866) is disposed through the flexible wall 860 through the inner surface 862. The needle 866 is therefore in fluid communication with a sterile reservoir 880 and a drug product 890 disposed within reservoir 880. Fluid communication between container needle 866 and injection needle 868 is interrupted by a valve 900 disposed in or along flexible tubing 870, which is the valve. 900 can define a boundary between the sterile part of the injector 850 and the clean part of the injector 850. Thus, unlike the other modalities discussed above in relation to Figs. 1-12, the actuator 856 of the injector 850 is not used to move the container needle 866 relative to the flexible wall 860, but rather to manipulate the valve between a closed state, in which fluid communication is interrupted between the needles 866 , 868 and an open state, in which the needle of the container 866 is in fluid communication with the injection needle 868.
[0086] It will be recognized that valve 900 can take a variety of shapes and forms, two of which are illustrated in Figs. 13 and 14. In particular, Fig. 13 illustrates an embodiment of the injector 850 in which a swivel valve 900 is disposed in flexible tube 870, or has an internal valve member that is in fluid communication with the defined fluid flow path. between the container needle 866 and the injection needle 868. Fig. 14, on the other hand, illustrates the injector mode in which a clamping valve 902 is disposed along the flexible tube 870 and therefore collaborates with a outer surface of tube 870 interrupts fluid communication between container needle 866 and injection needle 868.
[0087] The modalities as illustrated in Figs. 13 and 14 would also work well with a container having a fixed needle, such that the container is in the form of a syringe, for example.
[0088] This will be further understood in the embodiments illustrated in Figs. 13 and 14 can be modified to incorporate a seal assembly including a plurality of walls and/or seals as illustrated in Fig. 7, for example. Fig. 15 illustrates this modality.
[0089] In particular, Fig. 15 illustrates an injector 920 with a container 922, a fluid delivery system 924, an actuator 926 and a seal assembly 928. The fluid delivery system 924 may include a container needle. 930, and an injection needle 932 and a flexible cannula or tube 934 connecting the needle of the container 930 and the injection needle 932. The injection needle 932 can be received within a cap 936 that preserves the cleanliness of the needle 932. needle 932 may also be in selective fluid communication with a sterile reservoir 940 and a drug product 942 disposed within reservoir 940, through a valve 944 disposed in or along flexible tubing 934. In this regard, injector 920 is similar to those illustrated in Figs. 13 and 14.
[0090] However, the seal 928 assembly of the injector 920 also has a flexible wall 950 and a clean barrier 952. The flexible wall 950 and the clean barrier 952 each have interior and exterior surfaces, with the interior surface of the flexible wall 950 defining, in part, the closed sterile reservoir 940. On the other hand, the clean barrier 952 is disposed outside the flexible wall 950 to define a closed clean space 954 between the flexible wall 950 and the clean barrier 952 in which a needle point 956 of container 930 can be arranged.
[0091] In this regard, the embodiment of Fig. 15 has two potential barriers: one in the form of valve 944 and a second in the form of placing point 956 within clean space 954. In fact, valve 944 can be controlled to provide a delay in injection of drug product 942 after the needle of container 930 has been caused to penetrate through flexible wall 950 in reservoir 940.
[0092] As will be recognized, devices in accordance with the present disclosure may have one or more advantages over conventional technology, any one or more of which may be present in a specific embodiment, in accordance with the features of the present disclosure included in this modality. As an example, these modalities maintain the sterility of the drug product until the time of use. As another example, the potential for drug product mixing is limited or eliminated before the time of use. As yet another example, the involuntary delivery of the drug product is limited or prevented prior to the time of use.
[0093] For illustrative purposes only, Fig. 16 provides another method 1000 for assembling supply devices according to any of the modalities disclosed above. Method 1000 follows the general processing flow described above with respect to Fig. 4. However, instead of referring to the cleanroom classifications in accordance with the US Federal Standard 209E, reference is made to the cleanroom classifications in accordance with the EU GMP standard. In addition, method 1000 provides additional optional paths (represented as a left or right branch) that can be followed in mounting the supply device. Therefore, method 1000 of Fig. 16 can be seen as complementing the above discussion in relation to Fig. 4.
[0094] Method 1000 for assembling supply devices starts at block 1002. Containers used in the device are initially stored in sealed tubes. As mentioned above, these containers may or may have been sterilized at some point. In block 1002, the tubes are cleaned, for example, using an automated scrubber in a Class C cleanroom. In block 1004, the Tyvek seal is removed (eg by a machine) and removed, for example, in a space that functioned as a Class A cleanroom, perhaps inside an insulator in a counter space operated in a Class C cleanroom.
[0095] The containers are filled and the lids are connected, and then the containers are refitted in the open tubes, in block 1006, in a space that functioned as a Class A clean room, perhaps inside an insulator in an opposite space operated in a Class C cleanroom. From this point on, two different alternate paths, or branches, are possible.
[0096] The filled containers can be left in the open tubes in block 1008. The tubes can be transported and taken to a storage space (eg the cold room) in block 1010.
[0097] If the route of block 1008, 1010 is followed, then method 1000 can continue with the tubes being transferred to an inspection room processing in block 1012. The filled containers are then undocked from the open tubes in the block of 1014 and supplied to an automated inspection machine in block 1016. Automated inspection of the filled containers takes place in block 1016, followed by the additional optional semi-automatic or manual inspection in block 1018.
[0098] Alternatively, the tubes can be waterproofed, replasticized and labeled, in block 1020. For example, the tubes can be waterproofed with Tyvek (eg using a Bausch + Strobel sealer), replasticized and then labeled in a clean room from Class C to block 1020. The tubes can then be stored, or even shipped, if necessary, to blocks 1022,1024.
[0099] Once storage or transport is complete, the tubes are scrubbed, for example using an automated scrubber in block 1026. In block 1028, the Tyvek seal is unpacked and removed. The filled containers can then be undocked for inspection at block 1030. Actions at blocks 1026, 1028, 1030 are carried out in a Class C cleanroom. An automated inspection can then be performed using a visual inspection machine designed for operation in a Class C cleanroom in block 1032.
[00100] Following any procedure, the filled containers, then inspected, can be transferred to Rondo trays in block 1034.
[00101] According to the first procedure, the Rondo trays can be sent directly to the 1036 block storage. If the 1036 block path is followed, the Rondo trays are transferred for processing to the device assembly room in the block 1038. The containers are disengaged in block 1040 and assembled with the other elements of the delivery device in block 1042 to define an assembled delivery device (e.g., an injector or an infuser).
[00102] Alternatively, the containers can be moved to the tubes, which are sealed, plasticized and labeled, in block 1044. For example, the tanks can be Tyvek-impermeable, plasticized and labeled, and then in a class clean room. C. The tubes can then be stored, or even sent for further processing if necessary, in blocks 1046, 1048. Once storage or transport is complete, the tubes are debugged, for example, using an automated debugger on the block 1050. In block 1052, the Tyvek seal is unpacked and removed, and the containers are uncracked. The filled containers can then be assembled with the other elements of the supply device in block 1054. The actions in blocks 1050, 1052, 1054 can all take place in a class C cleanroom.
[00103] In any event, the assembled devices are bundled in block 1056, and the assembled, bundled devices are stored in block 1058. Finally, the assembled, bundled devices are transported to the distributor, and/or to other distribution actions in the block 1060.
[00104] Other advantages not specifically listed in this document may also be recognized. Furthermore, still other variants and alternatives are possible.
[00105] As an example, while the operation of the actuator has been described in relation to the preceding modalities such as moving, for example, the needle of the container from a storage state to a supply state, it will be understood that the actuator can also move the container needle from the supply state to the storage state. For example, if a dose of the drug product is to be delivered, ie less than the reservoir volume (as may be the case where the injector is designed to be programmed to deliver an adjustable dose as needed (eg pediatric vs adult patient)), then the trigger can move the container needle from the storage state to the delivery state before dose delivery and from the delivery state to the storage state after the dose delivery. Moving from the supply state to the storage state will, in effect, reseal the container and close the fluid path to the patient. This sequence of movement between the storage state and the supply state can be repeated. As noted above, maintaining a closed fluid path until delivery is initiated is advantageous in that the opportunity for unintentional delivery of drug product to the patient and/or mixing of drug product with the patient's bodily fluids is reduced.
[00106] Injectors in accordance with the present disclosure can be used with a variety of drug products, including colony stimulating factors such as granulocyte colony stimulating factor (G-CSF), can be administered to increase the number of immune system cells (eg white blood cells) found in bone marrow or peripheral blood. Such G-CSF agents include, but are not limited to, Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).
[00107] In other embodiments, the injector can be used with various other products, including, for example, an erythropoiesis stimulating agent (ESA), which can be in a liquid or a lyophilized form. ESA is any molecule that stimulates erythropoiesis, such as Epogen® (epoetin alpha), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK-2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alpha), epoetin alpha Hexal, Abseamed® (epoetin alpha), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa, epoetin beta, epoetin zeta, epoetin theta and epoetin delta, as well as the respective molecules or variants or analogues, as disclosed in the following patents or patent applications, each one of which is incorporated herein by reference in its entirety: Pat. US 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,986,047; 6,583,272; 7,084,245; and 7,271,689; and Publ. PCT Nos. WO 91/05867; WO 95/05465; WO 96/40772; WO 00/24893; WO 81405/01; and WO 2007/136752.
[00108] ESA may be an erythropoiesis stimulating the protein. As used herein, "erythropoiesis" stimulating protein" means any protein that directly or indirectly causes activation of the erythropoietin receptor, for example, binding to and causing receptor dimerization. Erythropoiesis stimulating proteins include erythropoietin and variants, analogues or derivatives thereof that bind and activate the erythropoietin receptor; antibodies that bind to the erythropoietin receptor and activate the receptor; or peptides that bind and activate the erythropoietin receptor. Erythropoiesis-stimulating proteins include, but are not limited to, epoetin alfa, epoetin beta, epoetin delta, epoetin omega, epoetin iota, epoetin zeta and the like, pegylated erythropoietin, erythropoietin carbamylate, mimetic peptides (including EMP1/hematid) mimetics. Exemplary erythropoiesis stimulating proteins include erythropoietin, darbepoetin, erythropoietin agonist variants, and peptides or antibodies that bind to and activate the erythropoietin receptor (and include compounds reported in US Publ. Nos. 2003/0215444 and 0040858/8). 2006, the disclosures each of which are incorporated herein by reference in their entirety) as well as erythropoietin molecules or variants or analogs thereof, as disclosed in the following patents or patent applications, which are each incorporated herein by reference in full. : Pat. US 4,703,008; 5,441,868; 5,547,933; 5,618,698; 5,621,080; 5,756,349; 5,767,078; 5,773,569; 5,955,422; 5,830,851; 5,856,298; 5,986,047; 6,030,086; 6,310,078; 6,391,633; 6,583,272; 6,586,398; 6,900,292; 6,750,369; 7,030,226; 7,084,245; and 7,217,689; Publication US 2002/0155998; 2003/0077753; 2003/0082749; 2003/0143202; 2004/0009902; 2004/0071694; 2004/0091961; 2004/0143857; 2004/0157293; 2004/0175379; 2004/0175824; 2004/0229318; 2004/0248815; 2004/0266690; 0019914/2005; 2005/0026834; 2005/0096461; 2005/0107297; 2005/0107591; 2005/0124045; 2005/0124564; 2005/0137329; 2005/0142642; 2005/0143292; 2005/0153879; 2005/0158822; 2005/0158832; 2005/0170457; 2005/0181359; 2005/0181482; 2005/0192211; 0202538/2005; 2005/0227289; 2005/0244409; 2006/0088906; and 0111279/2006; and Publ. PCT Nos. WO 91/05867; WO 95/05465; WO 99/66054; WO 00/24893; WO 81405/01; WO 00/61637; WO 36489/01; WO 02/014356; WO 19963/02; WO 02/20034; WO 02/49673; WO 02/085940; WO 029291/03; WO 2003/055526; WO 2003/084477; WO 2003/094858; WO 2004/002417; WO 2004/002424; WO 2004/009627; WO 2004/024761; WO 2004/033651; WO 2004/035603; WO 2004/043382; WO 2004/101600; WO 2004/101606; WO 2004/101611; WO 2004/106373; WO 2004/018667; 001025/WO 2005; WO 2005/001136; WO 2005/021579; WO 2005/025606; WO 2005/032460; WO 2005/051327; WO 2005/063808; WO 2005/063809; WO 2005/070451; WO 2005/081687; WO 2005/084711; WO 2005/103076; WO 2005/100403; WO 2005/092369; WO 2006/50959; WO 2006/02646; and WO 2006/29094.
[00109] Examples of other pharmaceuticals for use with the device may include, but are not limited to antibodies such as Vectibix® (panitumumab), Xgeva™ (denosumab) and Prolia™ (denosamab); other biological agents such as Enbrel® (etanercept, Fc/TNF receptor fusion protein, TNF blocker), Neulasta® (pegfilgrastim, pegylated filgrastim, pegylated G-CSF, pegylated hu-MetG-CSF), Neupogen® (filgrastim, G -CSF, hu-MetG-CSF) and Nplate® (romiplostim); small molecule medicines such as Sensipar® (cinacalcet). The device can also be used with a therapeutic antibody, a polypeptide, a protein or other chemicals such as iron, for example, ferumoxytol, iron dextrans, ferric gluconate and iron sucrose. The pharmaceutical product can be in liquid form, or reconstituted in a lyophilized form.
[00110] Among the particulars of the illustrative proteins are the specific proteins below, including fusions, fragments, analogs, variants or derivatives thereof:
OPGL specific antibodies, peptibodies and related proteins, and the like (also known as RANKL specific antibodies, peptibodies and the like), including human OPGL specific antibodies and fully humanized antibodies, particularly fully humanized monoclonal antibodies , including but not limited to the antibodies described in Publ. PCT No. WO 002713/03, which is incorporated herein in its entirety as to OPGL specific antibodies and related antibody proteins, particularly those having the sequences set forth therein, particularly, but not limited to, those defined therein: 9H7; 18B2; 2-8; 2E11; 16E1; and 22B3, including the OPGL specific antibodies having either the light chain of SEQ ID NO:2 as set forth in Figure 2 and/or the heavy chain of SEQ ID NO:4, as defined hereinafter in Figure 4, each. which is individually and specifically incorporated by reference herein in its entirety as disclosed in the preceding publication;
Myostatin binding proteins, peptibodies, and related proteins, and semilar, including myostatin-specific peptibodies, particularly those described in Publ. US No. 2004/0181033 and Publ. PCT No. WO 2004/058988, which are incorporated by reference herein in their entirety, particularly in parts pertinent to myostatin-specific peptibodies, including, but not limited to, TN8-19 family peptibodies, including those of SEQ ID NOS: 305-351, including TN8-19-1 to TN8-19-40, TN8-19 con1 and con2 TN8-19; peptibodies from the mL2 family of SEQ ID NOS: 357-383; the ml15 family of SEQ ID NOS: 384409; the ml17 family of SEQ ID NOS: 410-438; the mL20 family of SEQ ID NOS: 439-446; the mL21 family of SEQ ID NOS: 447-452; the mL24 family of SEQ ID NOS: 453-454; and those of SEQ ID NOS: 615-631, each of which is individually and specifically incorporated by reference herein in its entirety as disclosed in the foregoing publication;
IL-4 receptor specific antibodies, peptibodies and related proteins, and the like, particularly those that inhibit the activities mediated by the binding of IL-4 and/or IL-13 to the receptor, including those described in Publ .PCT No. WO 2005/047331 or application. PCT No. PCT/US2004/03742 and in Publ. US No. 2005/112694, which is incorporated herein by reference in its entirety, particularly in parts pertinent to IL-4 receptor specific antibodies, particularly such antibodies as are described herein, particularly and without limitation to the one designated therein: L1H1 ; L1H2; L1H3; L1H4; L1H5; L1H6; L1H7; L1H8; L1H9; L1H10; L1H11; L2H1; L2H2; L2H3; L2H4; L2H5; L2H6; L2H7; L2H8; L2H9; L2H10; L2H11; L2H12; L2H13; L2H14; L3H1; L4H1; L5H1; L6H1, each is individually and specifically incorporated by reference in this document in its entirety as disclosed in the preceding publication;
Interleukin 1-receptor 1 ("IL1-R1") of specific antibodies, peptibodies and related proteins, and the like, including but not limited to those described in Publ. U.S. No. 2004/097712A1, which is incorporated herein by reference in its entirety in pertinent parts to IL1-R1 specific binding proteins, monoclonal antibodies, in particular, especially, without limitation, the one designated therein: 15CA, 26F5, 27F2, 24E12 and 10H7 , each is individually and specifically incorporated by reference in this document in its entirety as disclosed in the aforementioned US publication.
[00115] Ang2 specific antibodies, peptibodies and related proteins and the like, including but not limited to those described in Publ. PCT No. WO 03/057134 and US Publ No. 2003/0229023, each of which is incorporated herein by reference in its entirety, particularly in parts pertinent to Ang2 specific antibodies and peptibodies and the like, especially those of sequences described therein and including but not limited to: L1(N); L1(N)WT; L1(N) 1K WT; 2xL1(N); 2xL1(N) WT; Con4 (N), Con4 (N) 1K WT, 2xCon4 (N) 1K; L1C; L1C 1K; 2xL1C; Con4C; Con4C 1K; 2xCon4C 1K; Con4-L1(N); Con4-L1C; TN-12-9 (N); C17 (N); TN8-8(N); TN8-14 (N); Con 1 (N), also including anti-Ang 2 antibodies and formulations as described in Publ. PCT No. WO 2003/030833 incorporated herein by reference in its entirety thereto, particularly Ab526; Ab528; Ab531; Ab533; Ab535; Ab536; Ab537; Ab540; Ab543; Ab544; Ab545; Ab546; A551; Ab553; Ab555; Ab558; Ab559; Ab565; AbF1AbFD; AbFE; AbFJ; AbFK; AbG1D4; AbGC1E8; AbH1C12; AblA1; AblF; AblK, AblP; and AblP, in its various permutations as described therein, each of which is individually and specifically incorporated by reference herein in its entirety in its entirety as disclosed in the preceding publication;
[00116] NGF-specific antibodies, peptibodies and related proteins, and as including, in particular, but not limited to those described in Publ. US No. 2005/0074821 and in US Patent no. 6,919,426, which are incorporated herein by reference in their entirety, particularly as to NGF-specific antibodies and related proteins in this regard, including, primarily, but not limited to, NGF-specific antibodies designated therein 4D4, 4G6, 6H9, 7H2, 14D10 and 14D11, each of which is individually and specifically incorporated by reference herein in its entirety as disclosed in the preceding publication;
CD22-specific antibodies, peptibodies, and related proteins and the like, such as those described in US Pat. 5,789,554, which are incorporated herein by referencing in their entirety to CD22 specific antibodies and related proteins, particularly humanized CD22 specific antibodies, such as, but not limited to, humanized and fully human antibodies, including, but not limited to, to humanized and fully human monoclonal antibodies, particularly including but not limited to human CD22 specific IgG antibodies, such as, for example, a dimer of a mouse to human monoclonal hLL2 gamma chain disulfide linked to a monoclonal hLL2 kappa chain of mouse to human, including, but limited to, for example, fully humanized human CD22 specific antibody on Epratuzumab, CAS registry number 501423-23-0;
[00118] IGF-1 receptor specific antibodies, peptibodies and related proteins and the like, such as those described in Publ. PCT No. WO 069202/06, which is incorporated herein by reference, in its entirety on IGF-1 receptor specific antibodies and related proteins, including but not limited to the IGF-1 specific antibodies designated therein L1H1, L2H2, L3H3, L4H4 , L5H5, L6H6, L7H7, L8H8, L9H9, L10H10, L11H11, L12H12, L13H13, L14H14, L15H15, L16H16, L17H17, L18H18, L19H19, L20H20, L21H21, L27, L29, L23H, L23H , L31H31, L32H32, L33H33, L34H34, L35H35, L36H36, L37H37, L38H38, L39H39, L40H40, L41H41, L42H42, L43H43, L44H44, L45H45, L46H46, L47H47, L48H48, L49H50, L49H linking fragments and derivatives thereof, each of which is individually and specifically incorporated by reference herein in its entirety as disclosed in the preceding International Publication;
[00119] Also among non-limiting are examples of anti-IGF-1R antibodies for use in the methods and compositions of the present invention, each and every one described in: (i) Publ. US No. 2006/0040358 (posted February 23, 2006), 2005/0008642 (posted January 13, 2005), 2004/0228859 (posted November 18, 2004), including, but not limited to, for example, antibody 1A (DSMZ deposit no. DSM ACC 2586), antibody 8 (DSMZ deposit no. DSM ACC 2589), antibody 23 (DSMZ deposit no. DSM ACC 2588) and antibody 18 as described therein; (ii) PCT No. WO 06/138729 (published 28 December 2006) and WO 05/016970 (published 24 February 2005) and Lu et al, 2004, J Biol Chem. 279:2856-65, including but not limited to the 2F8, A12 and IMC-A12 antibodies as described therein; (iii) PCT No. WO 012614/07 (published February 1, 2007), WO 000328/07 (published January 4, 2007), WO 06/013472 (published February 9, 2006), WO 058967/05 (published 30 June 2005) and WO 03/059951 (published July 24, 2003); (iv) US No. 2005/0084906 (published April 21, 2005), including but not limited to 7C10 antibody, C7C10 chimeric antibody, h7C10 antibody, 7H2M antibody, chimeric antibody *7C10, GM 607 antibody, 7C10 humanized antibody version 1, 7C10 humanized antibody version 2, humanized antibody 7C10 version 3, and antibody 7H2HM, as described therein; (v) US Nos. 2005/0249728 (posted November 10, 2005), 2005/0186203 (posted August 25, 2005), 2004/0265307 (posted December 30, 2004) and 2003/0235582 (posted December 25, 2003 ) and Maloney et al., 2003, Cancer Res. 63:5073-83, including but not limited to the EM164 antibody, resurrected from EM164, humanized EM164, huEM164 v 1.0, huEM164 v 1.1, huEM164 v 1.2 and huEM164 v 1.3 as described in him; (vi) Pat. US No. 7,037,498 (issued May 2, 2006), Publ. US Nos. 2005/0244408 (posted November 30, 2005) and 2004/0086503 (posted May 6, 2004) and Cohen, et al., 2005, Clinical Cancer Res. 11:2063-73, eg antibody numbers CP-751,871, including but not limited to each of the antibodies produced by the hybridomas having ATCC accession numbers PTA-2792 PTA-2788, PTA-2790, PTA-2791, PTA-2789, PTA-2793 and the 2.12.1 antibodies 2.13.2, 2.14.3, 3.1.1, 4.9.2 and 4.17.3, as described therein; (vii) US Nos. 2005/0136063 (posted June 23, 2005) and 2004/0018191 (posted January 29, 2004), including but not limited to the 19D12 antibody and an antibody comprising a heavy chain encoded by a polynucleotide in plasmid 15H12/19D12 HCA (Y4), deposited with the ATCC under the number PTA-5214 and a light chain encoded by a polynucleotide in plasmid 15H12/19D12 LCF (K), deposited with the ATCC under the number PTA-5220, as described herein; and (viii) Publ. US No. 2004/0202655 (posted October 14, 2004), including but not limited to PINT-6A1, PINT-7A2, PINT-7A4, PINT-7A5, PINT-7A6, PINT-8A1, PINT-9A2, PINT-11A1 antibodies , PINT-11A2, PINT-11A3, PINT-11A4, PINT-11A5, PINT-11A7, PINT-11A12, PINT-12A1, PINT-12A2, PINT-12A3, PINT-12A4 and PINT-12A5 as described herein; each and all of which are incorporated herein by reference in their entirety, particularly as to the aforementioned antibodies, peptibodies, and related proteins and the like that target IGF-1 receptors;
Antibodies specific 1 to B-7 related proteins, peptibodies, related proteins and the like ("B7RP-1," is also referred to in the literature as B7H2, ICOSL, B7h and CD275), particularly the human monoclonal IgG2 antibody fully specific B7RP, particularly the fully human monoclonal IgG2 antibodies that bind an epitope in the first domain such as immunoglobulin of B7RP-1, especially those that inhibit the interaction B7RP-1 with its natural ICOS receptor, on the activated T cell in particular, especially, in all the foregoing considerations, those disclosed in Publ. U.S. No. 2008/0166352 and Publ. PCT No. WO 07/011941, which are incorporated herein by reference in their entirety to such antibodies and related proteins, including but not limited to the antibodies designated herein as follows: 16H (having light chain variable and heavy chain variable sequences SEQ ID NO: 1 and SEQ ID NO: 7 herein respectively); 5D (having light chain variable and heavy chain variable sequences SEQ ID NO: 2 and SEQ ID NO: 9 herein respectively); 2H (having light chain variable and heavy chain variable sequences SEQ ID NO:3 and SEQ ID NO:10 herein respectively); 43H (having light chain variable and heavy chain variable sequences SEQ ID NO: 6 and SEQ ID NO: 14 herein respectively); 41H (having light chain variable and heavy chain variable sequences SEQ ID NO: 5 and SEQ ID NO: 13 herein respectively); and 15H (having light chain variable and heavy chain variable sequences SEQ ID NO: and SEQ ID NO: 12 herein respectively), each is individually and specifically incorporated by reference herein in its entirety as disclosed in the foregoing U.S. Publication;
IL-15 specific antibodies, peptibodies and related proteins, and the like, such as particularly humanized monoclonal antibodies, particularly antibodies such as those disclosed in Publ.U.S. US. 2003/0138421; 023586/2003; and 0071702/2004; and in US Patent no. 7,153,507, each of which is incorporated herein by reference in its entirety as to IL-15 specific antibodies and related proteins, including peptibodies, including particularly, for example, but not limited to, HuMax IL-15 antibodies and related proteins such as, for example, 146B7;
Gamma IFN specific antibodies, peptibodies, and related proteins and the like, especially human gamma IFN specific antibodies, particularly fully anti-human gamma IFN antibodies, such as, for example, those described in Publ. US No. 2005/0004353, incorporated herein by reference, in their entirety as the IFN gamma specific antibodies, particularly, for example, the antibodies designated herein as 1118; 1118*; 1119; 1121; and 1121*. The entire heavy and light chain sequences of each of these antibodies, as well as their light and heavy chain variable region sequences and complementarity determining regions, are each individually and specifically incorporated by reference herein in their entirety as disclosed in Previous US Publication and in Thakur et al., Mol. Immunol. 36:1107-1115 (1999). Furthermore, the description of the properties of these antibodies provided in the above US publication is also incorporated by reference herein in its entirety. Specific antibodies include those having the heavy chain of SEQ ID NO:17 and the light chain of SEQ ID NO:18; those having the heavy chain variable region of SEQ ID NO:6 and the light chain variable region of SEQ ID NO:8; those having the heavy chain of SEQ ID NO:19 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO:10 and the light chain variable region of SEQ ID NO:12; those having the heavy chain of SEQ ID NO:32 and the light chain of SEQ ID NO:20; those having the heavy chain variable region of SEQ ID NO:30 and the light chain variable region of SEQ ID NO:12; those having the heavy chain sequence of SEQ ID NO:21 and the light chain sequence of SEQ ID NO:22; those having the heavy chain variable region of SEQ ID NO:14 and the light chain variable region of SEQ ID NO:16; those having the heavy chain of SEQ ID NO:21 and the light chain of SEQ ID NO:33; and those with the heavy chain variable region of SEQ ID NO:14 and the light chain variable region of SEQ ID NO:31, as disclosed in the preceding US Publication. The specific antibody contemplated is antibody 1119 as disclosed in the above US Publication and having a complete heavy chain of SEQ ID NO:17 as disclosed herein and a complete light chain of SEQ ID NO:18 as disclosed herein;
[00123] TALL-1 specific antibodies, peptibodies, and related proteins, and the like, and other TALL specific binding proteins, such as those described in Publ. US 0195156/2003 and 2006/0135431, each of which is incorporated herein by reference in its entirety as to TALL-1, binding proteins, particularly the molecules of Tables 4 and 5B, each of which is individually and specifically incorporated by reference. in this document in its entirety as disclosed in preceding US Publications;
[00124] Parathyroid hormone-specific antibodies ("PTH"), peptibodies, and related proteins, and the like, as described in US Pat. 6,756,480, which is incorporated herein by reference in its entirety, particularly in portions pertinent to PTH-binding proteins;
Thrombopoietin receptor-specific antibodies ("TPO-R"), peptibodies, and related proteins, and the like, such as those described in US Pat. 6,835,809, which is incorporated herein by reference in its entirety, particularly in portions pertinent to TPO-R binding proteins;
[00126] Hepatocyte growth factor ("HGF") specific antibodies, peptibodies, and related proteins, and the like, including those targeting the HGF/SF:cMet axis (HGF/SF:c-Met), such as fully human monoclonal antibodies that neutralize hepatocyte growth/dispersion factor (HGF/SF) described in Publ. US No. 2005/0118643 and Publ. PCT No. WO 2005/017107, huL2G7 described in US Patent no. 7,220,410 and OA-5d5 described in US Patent Nos. 5,686,292 and 6,468,529 and in Publ. PCT No. WO 96/38557, each of which is incorporated herein by reference in their entirety, particularly in parts pertinent to HGF-binding proteins;
TRAIL-R2 specific antibodies, peptibodies, related proteins, and the like, as described in US Pat. 7,521,048, which is incorporated herein by reference in its entirety, particularly in portions pertinent to TRAIL-R2 binding proteins;
[00128] Specific Activin A antibodies, peptibodies, related proteins, and the like, including but not limited to those described in Publ. US No. 2009/0234106, which is incorporated herein by reference in its entirety, particularly in portions pertinent to Activin A-binding proteins;
PCSK9 (Proprotein convertase subtilisin/Kexin) specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in US Patent No. 8,030.457, WO 11/0027287 and WO 09/026558, which are incorporated herein by reference in their entirety, particularly in parts pertinent to PCSK9 binding proteins;
Beta TGF-specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in US Patent No. 6,803,453 and in Publ. US No. 2007/0110747, each of which is incorporated herein by reference in its entirety, particularly in parts pertinent to beta TGF binding proteins;
Antibodies specific to amyloid beta proteins, peptibodies, related proteins, and the like, including but not limited to those described in Publ. PCT No. WO 2006/081171 , incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind beta amyloid proteins. The antibody contemplated is an antibody having a heavy chain variable region comprising SEQ ID NO: 8 and a light chain variable region having SEQ ID NO: 6 as disclosed in the International Publication;
[00132] c-Kit specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in Publ. No. 2007/0253951, which is incorporated herein by reference in its entirety, particularly in parts pertinent to c-Kit binding proteins and/or other stem cell factor receptors;
[00133] OX40L specific antibodies, peptibodies, related proteins, and the like, including but not limited to those described in Appl. US No. 11/068, 289, which is incorporated herein by reference in its entirety, particularly in parts pertinent to proteins that bind to OX40L and/or other OXO40 receptor bindings; and
[00134] Other exemplary proteins may include Activase® (alteplase, tPA); Aranesp® (darbepoetin alfa); Epogen® (epoetin alfa, or erythropoietin); Avonex® (interferon beta-1a); Bexxar® (tositumomab, anti-CD22 monoclonal antibody); Betaseron® (interferon-beta); Campath® (alemtuzumab, anti-CD52 monoclonal antibody); Dynepo® (epoetin delta); Velcade® (bortezomib); MLN0002 (anti-α4β7 mAb); MLN1202 (anti-CCR2 chemokine receptor mAb); Enbrel® (etanercept, Fc/TNF receptor fusion protein, TNF blocker); Eprex® (epoetin alpha); Erbitux® (cetuximab, anti-EGFR/HER1/c-ErbB-1); Genotropin® (somatropin, human growth hormone); Herceptin® (trastuzumab, anti-HER2/neu (erbB2) receptor mAb); Humatrope® (somatropin, human growth hormone); Humira® (adalimumab); insulin in solution; Infergen® (interferon alfacon-1); Natrecor® (nesiritide; recombinant human type B natriuretic peptide (hBNP); Kineret® (anakinra); Leukine® (sargamostim, rhuGM-CSF); LymphoCide® (epratuzumab, anti-CD22 mAb); Benlysta™ (lymphocyte B, belimumab, anti-Jane mAb); Metalise® (tenecteplase, t-PA analog); Mircera® (methoxy polyethylene glycol-epoetin beta); Mylotarg® (Gentuzumab ozogamicin); Raptiva® (efalizumab); Cimzia® (certolizumab pegol, CDP 870) ; Soliris™ (eculizumab); pexelizumab (anti-C5 supplement); Numax® (MEDI-524); Lucentis® (ranibizumab); Panoramic® (17-1A, edrecolomab); Trabio® (lerdelimumab); HR3 TheraCim (nimotuzumab) ; Omnitarg (Pertuzumab, 2-4); Osidem® (IDM-1); OvaRex® (B43.13); Nuvion® (visilizumab); cantuzumab mertansine (huC242-DM1); NeoRecormon® (epoetin beta); Neumega® ( oprelvekin, human interleukin-11); Neulasta® (pegylated filgrastim, pegylated G-CSF, pegylated hu-met-G-CSF); Neupogen® (filgrastim, G-CSF, hu-MetG-CSF); Orthoclone OKT3® (muromonab -CD3, anti-CD3 monoclonal antibody); Procrit® (epoetin alpha); Remicade® (infliximab, anti-TNFα monoclonal antibody); ReoPro® (abciximab, anti-GP IIb/Ilia receptor monoclonal antibody); Actemra® (anti-IL6 Receptor mAb); Avastin® (bevacizumab), HuMax-CD4 (zanolimumab); Rituxan® (rituximab, anti-CD20 mAb); Tarceva® (erlotinib); Roferon-A® (interferon alpha-2a); Simulect® (basiliximab); Prexige® (lumiracoxib); Synagis® (palivizumab); 146B7-CHO (anti-IL15 antibody, see patent no. 7,153,507); Tysabri® (natalizumab, anti-α4integrin mAb); Valortim® (MDX1303, anti-B. anthracis antigen protective mAb); ABthrax™; Vectibix® (panitumumab); Xolair® (omalizumab); ETI211 (anti-MRSA mAb); Il-1 Trap (the Fc portion of human IgG1 and the extracellular domains of both components of the IL-1 receptor (the receptor type and the accessory protein of the receptor)); VEGF Trap (Ig domains of VEGFR1 fused to IgG1 Fc); Zenapax® (daclizumab); Zenapax® (daclizumab, anti-IL-2Rα mAb); Zevalin® (ibritumomab tiuxetan); Zetia® (ezetimibe); Orencia® (atacicept, TACI-Ig); anti-CD80 monoclonal antibody (galiximab); anti-CD23 mAb (lumiliximab); Br2-Fc (huBR3/huFc, fusion protein, soluble BAFF antagonist); CNTO 148 (golimumab, anti-TNFα mAb); DFM-ETR1 (mapatumumab; human antiTRAIL Receptor-1 mAb); HuMax-CD20 (ocrelizumab, anti-human CD20 mAb); HuMax-EGFR (zalutumumab); M200 (volociximab, anti-α5β1 integrin mAb); MDX-010 (ipilimumab, anti-CTLA-4 and VEGFR-1 mAb (IMC-18F1); anti-BR3 mAb; anti-C. difficile toxin A and BC toxin mAbs MDX-066 (CDA-1) and MDX-1388 ); anti-CD22 dsFv-PE38 conjugates (CAT-3888 and CAT-8015); anti-CD25 mAb (HuMax-TAC); anti-CD3 mAb (NI-0401); adecatumumab; anti-CD30 mAb (MDX-060); MDX-1333 (anti-IFNAR); anti-CD38 mAb (HuMax CD38); anti-CD40L mAb; anti-Crypto mAb; Fibrinogen anti-CTGF idiopathic pulmonary fibrosis stage I (FG-3019); anti-CTLA4 mAb; anti-eotaxin1 mAb (CAT-213); anti-FGF8 mAb; anti-GD2 ganglioside mAb; anti-GM2 ganglioside mAb; anti-human GDF-8 mAb (MYO-029); anti-GM-CSF Receptor mAb (CAM-3001); anti-HCV mAb (HuMax HepC); anti-IFNα mAb (MEDI-545, MDX-1103); anti-IGF1R mAb; anti-IGF-1R mAb (HuMax-inflam); anti-IL12 mAb (ABT-874); anti-IL12/IL23 mAb (CNTO 1275); anti-IL13 mAb (CAT-354); anti-IL2Ra mAb (HuMax-TAC); anti-IL5 Receptor mAb; anti-integrin receptor mAb (MDX-018, CNTO 95); anti-IP10 ulcerative colitis mAb (MDX-1100); anti-LLY antibody; BMS-66513; anti-mannose Receptor/hCGβ mAb (MDX-1307); anti-mesoteline dsFv-PE38 conjugate (CAT-5001); anti-PD1mAb (MDX-1106 (ONO-4538)); anti-PDGFRα antibody (IMC - 3 3); anti-TGFβ mAb (GC-1008); human anti-TRAIL Receptor-2 mAb (DFM-ETR2); anti-TWEAK mAb; anti-VEGFR/Flt-1 mAb; anti-ZP3 mAb (HuMax-ZP3); NVS #1 antibody; and NVS antibody #2.

权利要求:
Claims (29)
[0001]
1. Injector (450) comprising: a container including a wall (390) with an interior surface (462) and a seal assembly with an interior surface (494), the interior wall surfaces and the seal assembly defining a reservoir ( 510); a lid (540) movably disposed on the container; a fluid delivery system comprising a clean, unsheathed, rigid container needle, with a point only partially disposed across the seal assembly in a storage state, and is disposed across the inner surface of the seal assembly in the sterile reservoir in a state of supply; an actuator (456) that is adapted to move the needle of the container (550) from the storage state to the supply state; and the injector characterized by: the sealing assembly comprising a septum (490) and a clean barrier (492) positioned externally to the septum (490) such that the septum (490) and the clean barrier (492) define a space ( 530) closed and clean disposed between the septum (490) and the clean barrier (492), the point of the container needle being arranged in a space (530) closed and clean in the storage state and disposed through the septum (490) in the supply status.
[0002]
2. Injector according to claim 1, characterized in that the wall of the container comprises a rigid wall.
[0003]
3. Injector according to claim 1, characterized in that the wall of the container comprises a flexible wall.
[0004]
4. Injector according to any one of claims 1 to 3, characterized in that the septum consists of a flexible unitary wall, having an interior surface that defines the interior surface of the septum.
[0005]
5. Injector according to claim 4, characterized in that the unitary flexible wall defines a septum eliminated through the opening and fixedly connected to the wall of the container.
[0006]
6. Injector according to claim 1, characterized in that the container wall defines a closed end opposite the lid and an open end, in which the lid is arranged.
[0007]
7. Injector according to claim 4, characterized in that the container wall defines a hole with an opening in fluid communication with a first end of the hole, and the unitary flexible wall defines a septum disposed through the opening and fixedly connected to the wall of the container.
[0008]
8. Injector according to any one of claims 1 to 3, characterized in that the septum comprises a flexible wall with an interior surface that defines the interior surface of the septum, and the needle point of the container disposed through the barrier clean to the clean space in the storage state.
[0009]
9. Injector according to claim 8, characterized in that the container wall defines a hole, and the clean barrier defines a lid that is movable along the hole.
[0010]
10. Injector according to claim 8, characterized in that the container comprises a vent in fluid communication with the space between the clean barrier and flexible wall.
[0011]
11. Injector according to claim 10, characterized in that the vent is formed in the clean barrier.
[0012]
12. Injector according to claim 10, characterized in that the vent is formed within the inner surface of the wall of the container.
[0013]
13. Injector according to claim 9, characterized in that the wall of the container defines a closed end opposite the lids and an open end, in which the lids are arranged.
[0014]
14. Injector according to claim 8, characterized in that the container wall defines a hole with an opening in fluid communication with a first end of the hole, and the flexible wall and each clean barrier define a septum disposed through the opening and fixedly connected to the wall of the container.
[0015]
15. Injector according to any one of claims 1 to 14, characterized in that the fluid supply system comprises clean flexible tubes connected at a first end to the needle of rigid containers and a second end to a needle of clean rigid injection received inside a clean cap that closes the clean rigid injection needle.
[0016]
16. Injector according to any one of claims 1 to 15, characterized in that it comprises a trigger that is adapted to move the container needle from the storage state to the supply state.
[0017]
17. Injector according to any one of claims 1 to 16, characterized in that the trigger is adapted to delay movement of the needle of the container from the storage state to the supply state after an input is received.
[0018]
18. Injector according to any one of claims 1 to 17, characterized in that it also comprises a mechanical, electromechanical or electrical input device, coupled to the actuator.
[0019]
19. Injector according to any one of claims 1 to 18, characterized in that the drug product comprises a volume of an erythropoiesis stimulating the agent.
[0020]
20. Injector according to any one of claims 1 to 18, characterized in that the drug product comprises a volume of a granulocyte colony stimulating factor.
[0021]
21. Injector according to any one of claims 1 to 18, characterized in that the drug product comprises a volume of a TNF blocker.
[0022]
22. Injector according to any one of claims 1 to 18, characterized in that the drug product comprises a volume of a pegylated granulocyte colony-stimulating factor.
[0023]
23. Injector according to any one of claims 1 to 18, characterized in that the product of the drug comprises a volume of specific antibodies to the interleukin receptor.
[0024]
24. Injector according to any one of claims 1 to 18, characterized in that the product of the drug comprises a volume of antibody specific for IGF receptors (Insulin Growth Factor receptor).
[0025]
25. Injector according to any one of claims 1 to 18, characterized in that the drug product comprises a volume of TGF-specific antibody.
[0026]
26. Injector according to any one of claims 1 to 18, characterized in that the drug product comprises a volume of PCSK9 (Proprotein convertase subtilisin/Kexin type 9) specific antibody.
[0027]
27. Method of assembling the injector (450), the method comprising: filling a reservoir (510) of a container with a drug, the reservoir (510) defined by an interior surface (462) of a wall (390) of the container and the inner surface (494) of a septum (490) of a seal assembly; the method being characterized by comprising: inserting a point (552) of a clean, unsheathed rigid container needle, partially through the seal assembly into a clean, closed space (530) between the septum (490) and a clean barrier ( 492) to define a storage state; and attaching the container needle (550) to a driver (456), the driver (456) adapted to move the container needle (550) from the storage state to a supply state wherein the point (552) of the container (550) is configured to be disposed through the septum (490) in the supplied state.
[0028]
28. Method according to claim 27, characterized in that the wall of the container is a rigid wall.
[0029]
29. Method according to claim 27, characterized in that the wall of the container is a flexible wall.

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TR201807808T4|2018-06-21|

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PL3045189T3|2018-09-28|

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EP3045189A1|2016-07-20|

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法律状态:
2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-11-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-12-08| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]|

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2021-04-06| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-06-08| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 11/10/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161547667P| true| 2011-10-14|2011-10-14|

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US61/547,667|2011-10-14|

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PCT/US2012/059680|WO2013055873A1|2011-10-14|2012-10-11|Injector and method of assembly|

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