Systems, apparatus, devices, and methods for packaging implantable analyte diffusion devices

Abstract

Embodiments of the present disclosure are directed to a biomedical packaging system that may include an assembly / primary packaging system having one chamber configured to hold a liquid nutrient medium and an artificial organ (BAO), and another chamber disposed adjacent to the first compartment configured to be substantially free of liquid. The system may further include a baffle including a port and configured to separate the first and second chambers, and a reservoir / secondary packaging.

Description

[Background technology]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This disclosure claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 929,619, filed November 1, 2019, and U.S. Provisional Patent Application No. 62 / 930,504, filed November 4, 2019, the disclosures of each of which are incorporated herein by reference in their entirety.

[0002] In pharmaceutical and medical device packaging, handling of BAOs is particularly important given the need to maintain BAO sterility and maintain the BAO in a condition suitable for surgical use / implantation. For example, when packaging and shipping BAOs, it is necessary to provide a package or container (which can be referred to as a packaging system) that provides biologically appropriate amounts of liquid nutrients for immersion and nourishment of the BAO. Furthermore, such a packaging system may be advantageous in (1) maintaining product sterility and providing mechanical protection (to minimize storage or transport damage), (2) maintaining gas and / or liquid isolation across the boundaries of the packaging system, (3) maintaining the BAO in a specific position (e.g., vertical, horizontal) so that the BAO can be continuously immersed in a liquid deposit, and (4) using the packaging system, or components thereof, as a device / tool ​​to facilitate transfer of the BAO from the packaging system to the surgical site by the clinician during a surgical procedure. Summary of the Invention

[0003] In some embodiments, a biomedical packaging system is provided that includes an assembly having one chamber (e.g., a first or lower chamber) configured to hold a liquid nutrient medium and an artificial organ (BAO), and another chamber (e.g., a second or upper chamber) disposed adjacent the other chamber and configured to be substantially free of liquid. The system can further include a baffle that includes a port and is configured to separate the chambers.

[0004] In such embodiments, at least one (and in some embodiments, a plurality thereof, and in some embodiments, all) of the following additional features, functionality, structures, steps, and / or descriptions may be included to lead to further embodiments: - the second chamber (or the first chamber) includes a flange; - at least one of the chambers, and in some embodiments, each chamber comprises a wall; - the wall of the first chamber is integral with the wall of the second chamber; - at least one wall of the chamber includes a step configured to retain or hold the periphery of the baffle; - at least one of the periphery of the baffle and the inner periphery of the wall of the first chamber and / or the wall of the second chamber comprises a material configured to seal the periphery of the baffle with the wall of the first chamber and / or the wall of the second chamber; - the second chamber is sealed with an impermeable membrane directly above or above the flange; -The port is centrally located on the baffle; - The port is closed via at least one closure system; the baffle is configured with a pitch; The slope is formed from the edge of the baffle to the center of the baffle; The slope can be between approximately 5 and 30 degrees; - the baffle may be configured to vent gas while the first chamber is filled with liquid; - the baffle may be sealed to at least one of the first and second chambers; - sealing may include ultrasonic welding; - The closure system can be configured as follows: Using a threaded connection; and as a stopper; or As a plug and corresponding socket, the plug and socket may be configured to couple together by a threaded connection, optionally including: The stopper and receptacle may include a luer taper; The plug and receptacle may be configured to be a friction fit with one another, or may additionally be configured to be a friction fit; the closure system further comprises a tapered seal and may also comprise at least one O-ring disposed on the bung, and optionally the receptacle comprises at least one corresponding recess configured to receive the at least one O-ring; - a storage container configured to contain the assembly; At least one or more portions of the first chamber, the second chamber, the baffle, and the reservoir may be made of a material having at least one of the following properties: transparent, medical grade, durable, non-degradable, substantially no release of excipients over time during exposure to high temperatures, high pH, ​​and / or high humidity; At least a portion of one or more of the first chamber, the second chamber, the baffle, and the storage vessel may be made of at least one of the following: polycarbonate, polyester resin, polyetheramide, polyethylene terephthalate, and polyethylene coglycol terephthalate; - a closure system including at least one of a stopper and a receptacle, each including an interface portion for supporting at least one medical device or BAO; and The port of the baffle may include a neck portion configured to receive at least one of a plug and a receptacle, and at least one of the plug, receptacle and neck may include corresponding connecting means configured to connect the at least one of the plug and receptacle with the neck portion.

[0005] These and other embodiments, objects and advantages will become more apparent upon reference to the accompanying drawings, briefly described below, and the detailed description of at least some of the embodiments, both of which are submitted herewith. [Brief explanation of the drawings]

[0006] [Figure 1] FIG. 1 shows a cross section of a packaging assembly according to some embodiments of the disclosure.

[0007] [Figure 2] FIG. 2 illustrates a top view of a package assembly according to some embodiments of the disclosure.

[0008] [Figure 3] FIG. 3 illustrates a cross-sectional view of a baffle for separating at least chambers of a package assembly according to some embodiments of the disclosure.

[0009] [Figure 4] 1 illustrates a cross-sectional view of a plug and receptacle for a packaging assembly / system according to some embodiments.

[0010] [Figure 5] FIG. 5 is a perspective view according to some embodiments, also showing the internal structure of the packaging system showing the assembly housed / nested within a storage container.

[0011] [Figure 6]FIG. 6 is a perspective / side view according to some embodiments, also showing the internal structure of the plug and socket structure for retaining biological tissue within the chamber of the assembly.

[0012] [Figure 7] FIG. 7 shows an exploded perspective view of a packaging assembly / system, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0013] 1-7 illustrate various embodiments of the subject disclosure. Biomedical packaging system 100 (see FIG. 5), as shown in FIG. 1, includes an assembly 101 having a first chamber 102 configured to hold a liquid nutrient medium and a bio-artificial organ (BAO), and a second chamber 104 disposed adjacent to first chamber 102 and configured to be substantially free of liquid. The system further includes a baffle 106 including a port 108 and configured to separate first chamber 102 from second chamber 104.

[0014] In such embodiments, the second chamber includes a flange 110 and at least one of the chambers 102 and 104, and in some embodiments, each chamber includes a wall 112, 114. The wall 112 of the first chamber 102 can be integral with the wall 114 of the second chamber. The wall 114 of the second chamber 104 can include a stepped edge 116 configured to retain or otherwise support the perimeter 106a of the baffle 106 (see FIGS. 2-3 ). The wall 114 of the second chamber 104 can include a recess or sill 114b that can be configured to retain or support the perimeter 106a of the baffle 106. At least one of the perimeter 106a of the baffle 106 and the inner perimeters 112a, 114a of the walls of the first chamber 102 and / or the second chamber 104 includes a material configured to seal the perimeter 106a of the baffle 106 with the wall 112 of the first chamber 102 and / or the wall 114 of the second chamber 104.

[0015] The second chamber 104 can be sealed with a non-permeable membrane 118 directly on or above the flange 110. In some embodiments, the port 108 can be centrally located on the baffle 106, and the port 108 can be closed via at least one closure system 120.

[0016] In some embodiments, the baffle is configured with a slope, where the slope may be formed from the edge 106a of the baffle 106 to the center 106b of the baffle, where the slope may be between an angle of about 5-30 degrees, and the baffle may be configured to vent gas during filling of the first chamber 102 with liquid, for example. The baffle 106 may be sealed to at least one of the first and second chambers, where the seal may include ultrasonic welding.

[0017] As shown in FIGS. 4 and 6 , in some embodiments, closure system 120 can comprise a threaded engagement or can be configured as a stopper 122 or a stopper and corresponding receptacle 124, where stopper 122 and receptacle 124 can be configured to couple to one another via a threaded engagement (for example). Optionally, a luer taper can be included in the stopper and receptacle, and / or stopper 122 and receptacle 124 can be configured to provide a friction fit or additional friction fit with one another. Closure system 120 can also include a seal (not shown), which can be tapered, and can also include at least one O-ring (not shown) disposed on stopper 122, and optionally, receptacle 124 can include at least one corresponding recess (not shown) configured to receive at least one O-ring. In some embodiments, the system can also include a storage container 132 configured to house assembly 101. 5, according to some embodiments, the storage container 132 can be designed and sized or configured to nest the assembly within the container. For example, the nesting configuration can keep the assembly in a substantially rigid configuration and / or provide support for the assembly contained therein.

[0018] In some embodiments, at least a portion of one or more of the first chamber 102, the second chamber 104, the baffle 106, and the storage container 132 can be fabricated from a material having at least one of the following properties: transparent, medical grade, durable, non-degradable, and substantially no release of excipients over time during exposure to high temperature, high pH, ​​and / or high humidity.

[0019] In some embodiments, at least a portion of one or more of the first chamber 102, the second chamber 104, the baffle 106, and the storage vessel 132 may be manufactured from at least one of the following: polycarbonate, polyester resin, polyetheramide, polyethylene terephthalate, and polyethylene coglycol terephthalate.

[0020] On top of the closure system 120 including at least one of the stopper 122 and the receptacle 124, each may include an interface configured to receive a clip 123 for supporting or retaining, for example, at least one of a medical device or a BAO. In some embodiments, the port 108 of the baffle 106 includes a neck 108a configured to receive at least one of the stopper 122 and the receptacle 124 (e.g., region 124a), wherein at least one of the stopper 124 and the receptacle 124 and the neck 108a may include corresponding connecting means configured to connect the at least one of the stopper 122 and the receptacle 124 with the neck 108a.

[0021] FIG. 7 depicts yet another aspect of a packaging system according to some embodiments of the present disclosure. As shown, packaging system 700 includes a primary packaging component 718 (sometimes referred to as an assembly; see also FIGS. 1-6 and the discussion above) housing a BAO 714, a clip 712, a primary package baffle 710, a receptacle including a stopper (sometimes referred to as a baffle cap) 706 and a retaining ring 708 (which itself may be considered a "stopper"), and a primary package lid 704. The packaging system according to such an embodiment may further include a secondary package including a base 708 including a recess 720 for receiving the primary package base (and the article packaged therein, and the lid 704). The secondary package may include an upper portion 722 comprising a rectangular shape, which may be useful for shipping the packaging system. In some embodiments, the secondary package may also be referred to as a storage container (e.g., see reference numeral 132 with respect to FIG. 5, although the secondary package may house the assembly and the container in some embodiments).

[0022] While various inventive embodiments have been described and illustrated, those skilled in the art can readily envision a variety of other means and / or structures for performing the functions described herein and / or obtaining one or more of the results and / or advantages described herein, and each such variation and / or modification is deemed to be within the scope of the embodiments of the invention described herein. In general, those skilled in the art will appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be examples, and that the actual parameters, dimensions, materials, and configurations will depend on the specific application in which the teachings of the invention are used. Those skilled in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalents to the specific embodiments described herein. Accordingly, the above-described embodiments are presented by way of example only, and it should be understood that within the scope of the claims, their equivalents, and claims supported by this disclosure, embodiments of the invention may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure relate to each individual feature, system, article, material, kit, method, and step described herein. Furthermore, any combination of two or more of these features, systems, articles, materials, kits, methods, and steps is within the scope of the present disclosure, provided that the features, systems, articles, materials, kits, methods, and steps are not mutually inconsistent. The embodiments disclosed herein may also be combined with one or more features and complete systems, apparatus, and / or methods to form further embodiments and inventions. Furthermore, some embodiments may be distinguished from the prior art by the apparent absence of one and / or another feature that is disclosed with reference to specific prior art. That is, claims of some embodiments may be distinguished from the prior art by the inclusion of one or more negative limitations.

[0023] Also, various inventive concepts may be embodied as one or more methods. The acts performed as part of a method may be in any suitable order. Thus, while exemplary embodiments may show acts as sequential, embodiments may be constructed in which the acts are performed in a different order than illustrated, and may include performing some acts simultaneously.

[0024] Any and all references to publications or other documents, including, but not limited to, patents, patent applications, articles, web pages, books, etc., presented in this application are incorporated herein by reference in their entirety. Furthermore, all definitions shall be construed to supersede dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms as defined and used herein.

[0025] As used in this specification and claims, unless expressly indicated otherwise, the indefinite article "a" or "an" should be construed to mean "at least one."

[0026] As used in the specification and claims, "and / or" should be interpreted to mean "either or both" of the combined elements, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the combined elements. Other elements other than the elements expressly identified by the "and / or" clause may optionally be present, whether related to the elements expressly identified by the "and / or" clause or not. Thus, as a non-limiting example, when "A and / or B" is used in conjunction with open-ended language such as "comprising," in one embodiment it can refer to A only (optionally including elements other than B), in another embodiment it can refer to B only (optionally including elements other than A), and in yet another embodiment it can refer to both A and B (optionally including other elements).

[0027] As used in the specification and claims, "or" should be construed to have the same meaning as "and / or," as described above. For example, when separating items in a list, "or" or "and / or" is intended to be inclusive, i.e., including at least one of the items or list (but also including more than one item), and optionally including additional unlisted items. Conversely, when used in expressly indicated only terms such as "only one of" or "exactly one of," or in the claims, "consisting of" means including only one element of the items or list. In general, when "or" is used herein, it will only be construed as indicating exclusive alternatives (i.e., "one or the other, but not both") when preceded by terms of exclusivity such as "any," "one of," "only one of," or "exactly one of." "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0028] As used in this specification and claims, "at least one of," when referring to a list of one or more elements, shall be interpreted to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each element explicitly listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those explicitly identified in the list of elements to which "at least one of" refers, whether related or unrelated to the elements explicitly identified. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B" or, equivalently, "at least one of A and / or B") refers, in one embodiment, to at least one (optionally multiple) A's, with no B (optionally including elements other than B); in another embodiment, to at least one (optionally multiple) B's, with no A's (optionally including elements other than A); and, in yet another embodiment, to at least one (optionally multiple) A's and at least one (optionally multiple) B's (and optionally including other elements).

[0029] In the claims and the specification, the transitional phrases "comprise," "include," "carry," "have," "contain," "with," "hold," "consisting of," and similar transitional phrases shall be construed as open-ended, i.e., meaning including, but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" shall be closed or semi-closed transitional phrases, respectively, as set forth in Section 2111.03 of the United States Patent Office Manual of Patent Examining Procedure. The following are some embodiments of the present invention. [Aspect 1] 1. A biomedical packaging system comprising an assembly: a first chamber configured to hold a liquid nutrient medium and a bioartificial organ (BAO); a second chamber disposed adjacent to the first compartment and configured to be substantially free of liquid; a baffle including a port and configured to separate the first chamber and the second chamber; A biomedical packaging system comprising: [Aspect 2] The system of embodiment 1, wherein the second chamber comprises a flange. [Aspect 3] 3. The system of embodiment 1 or 2, wherein each chamber comprises a wall. [Aspect 4] 4. The system of embodiment 3, wherein the wall of the first chamber is integral with the wall of the second chamber. [Aspect 5] The system of any of the preceding embodiments, wherein the wall of the second chamber includes a stepped edge configured to retain or support a perimeter of the baffle. [Aspect 6] The system of any one of aspects 1-4, wherein a wall of the second chamber includes a recess configured to hold or support a periphery of the baffle. [Aspect 7] A system described in any one of aspects 1 to 6, wherein at least one of a periphery of the baffle and an inner periphery of the first chamber wall and / or the second chamber wall comprises a material configured to seal the periphery of the baffle with the first chamber wall and / or the second chamber wall. [Aspect 8] The system of any one of aspects 1 to 7, wherein the second chamber is sealed with an impermeable membrane directly on or above the flange. [Aspect 9] The system of any one of aspects 1-8, wherein the port is centrally located on the baffle. [Aspect 10] The system of any of the preceding aspects, wherein the ports are closed via at least one closure system. [Aspect 11] The system of any one of the first to tenth aspects, wherein the baffle is configured with an inclination. [Aspect 12] 12. The system of any one of aspects 1 to 11, wherein a slope is formed from an edge of the baffle to a center of the baffle. [Aspect 13] 13. The system of claim 11 or 12, wherein the inclination is between about 5 degrees and 30 degrees. [Aspect 14] 14. The system of any one of aspects 1-13, wherein the baffle is configured to vent gas during filling of the first chamber with liquid. [Aspect 15] 15. The system of any one of aspects 1-14, wherein the baffle is sealed to at least one of the first chamber and the second chamber. [Aspect 16] 16. The system of embodiment 15, wherein the sealing comprises ultrasonic welding. [Aspect 17] 11. The system of embodiment 10, wherein the closure system is configured using a threaded engagement. [Aspect 18] 11. The system of embodiment 10, wherein the closure system comprises a bung. [Aspect 19] 11. The system of embodiment 10, wherein the closure system comprises a plug and a corresponding receptacle. [Aspect 20] 20. The system of embodiment 19, wherein the plug and the socket are coupled to one another via a threaded engagement. [Aspect 21] 20. The system of embodiment 19, wherein the plug and the receptacle include a luer taper. [Aspect 22] 22. The system of any one of aspects 19-21, wherein the plug and the socket are configured to have a friction fit with each other, or are additionally configured to have a friction fit with each other. [Aspect 23] The system of any one of embodiments 10-22, wherein the closure system further comprises a tapered seal. [Aspect 24] 20. The system of any one of embodiments 18-19, further comprising at least one O-ring disposed on the stopcock. [Aspect 25] 25. The system of embodiment 24, wherein the receptacle includes at least one corresponding recess configured to receive at least one O-ring. [Aspect 26] A system according to any one of aspects 19 to 25, wherein at least one of the plug and the socket includes an interface for supporting at least one of a medical device or a BAO. [Aspect 27] Aspects 19-26, wherein the baffle port includes a neck configured to receive at least one of the plug and the receptacle. [Aspect 28] A system as described in aspect 27, wherein at least one of the plug and the socket and the neck portion include corresponding connection means configured to connect the at least one of the plug and the socket and the neck portion. [Aspect 29] The system of any one of embodiments 1-28, further comprising a storage vessel. [Aspect 30]

[0033] Aspect 30. The system of any one of aspects 1-29, wherein at least a portion of one or more of the first chamber, the second chamber, the baffle, and the storage container are fabricated from a material having at least one of the following properties: transparent, medical-grade, durable, non-degradable, and exhibiting substantially no release of excipients over time upon exposure to high temperature, high pH, ​​and / or high humidity. [Aspect 31] 30. The system of any one of aspects 1-29, wherein at least a portion of one or more of the first chamber, the second chamber, the baffle, and the storage vessel is fabricated from at least one of polycarbonate, polyester resin, polyetheramide, polyethylene terephthalate, and polyethylene co-glycol terephthalate. [Aspect 32] A system, device, apparatus, or method according to any of the disclosed embodiments.

Claims

1. a first chamber (102) configured to hold a liquid nutrient medium and a bioartificial organ (BAO); a second chamber (104) disposed adjacent to the first chamber and configured to be substantially free of liquid; A biomedical packaging system (100) including an assembly comprising: The system includes a baffle (106) including a port (108) and configured to separate the first chamber (102) from the second chamber (104), the first chamber (102) being positioned below the second chamber (104); the baffle (106) is sealed to at least one of the first chamber (102) and the second chamber (104); said ports (108) being closed via at least one closure system (120); 10. A biomedical packaging system, wherein the first chamber (102) is separated from the interior space of the second chamber (104) by the baffle (106).

2. The system of claim 1 , wherein the second chamber includes a flange (110).

3. The system of claim 1 or 2, wherein each chamber comprises a wall (112), (114).

4. The system of claim 3, wherein the wall (112) of the first chamber (102) is integral with the wall (114) of the second chamber (104).

5. 5. The system of claim 3 or claim 4, wherein the wall (114) of the second chamber (104) includes a stepped edge (116) configured to retain or support the perimeter (106a) of the baffle (106).

6. 6. The system of claim 3, wherein the wall (114) of the second chamber (104) includes a recess (114b) configured to hold or support the periphery (106a) of the baffle (106).

7. at least one of the perimeter (106a) of the baffle (106) and the inner perimeter (112a) of the wall (112) of the first chamber (102) comprises a material configured to seal the perimeter (106a) of the baffle (106) with the wall (112) of the first chamber (102); and / or 4. The system of claim 3, wherein at least one of the perimeter (106a) of the baffle (106) and the inner perimeter (114a) of the wall (114) of the second chamber (104) comprises a material configured to seal the perimeter (106a) of the baffle (106) with the wall (114) of the second chamber (104).

8. 3. The system of claim 2, wherein the second chamber (104) is sealed with an impermeable membrane directly on or above the flange (110), the impermeable membrane being impermeable to gases and / or water.

9. The system of any one of claims 1 to 8, wherein the port (108) is centrally located on the baffle (106).

10. The system of any one of claims 1 to 9, wherein the baffle (106) is configured with an inclination.

11. The system of any one of claims 1 to 10, wherein a slope is formed from an edge of the baffle (106) to a center of the baffle (106).

12. 12. The system of claim 10 or claim 11, wherein the inclination is between about 5 degrees and 30 degrees.

13. 13. The system of claim 1, wherein the baffle (106) is configured to vent gas during filling of the first chamber (102) with liquid.

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