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

Abstract

To provide a system, apparatus, device and method for an implantable analyte diffusion device.SOLUTION: Embodiments of the present disclosure include, for example, a medical device system including an implantable analyte diffusion device (ADID), the device comprising a cavity, a cell scaffold material (CSM) arranged within the cavity and configured to carry or otherwise retain a plurality of living cells adapted to secrete a therapeutic protein-based drug, and a porous hollow fiber membrane at least partially surrounding the cavity, wherein at least a portion of the membrane is adhered to the CSM by a high durometer adhesive that creates a hemispherical seal at both ends of the membrane. The system also includes a fill port having a dock means at a first end and a micro-diameter tube (MDT) extending from a second end. The MDT is sealed at a distal end to the fill port and at a proximal end to the cavity of the ADID to establish an integral cell fill pathway therein.SELECTED DRAWING: Figure 1

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] Transporting artificial organs (BAOs) or alternatively implantable medical devices, especially small ones (e.g., fingertip-sized or smaller), can be quite challenging. Given their size, improper handling can lead to damage or compromised sterility of the device, resulting in disposal if detected and posing a potential risk to the patient if undetected. Furthermore, these types of devices, whether they require filling with substances or multiple steps in the manufacturing process, require delicate handling and associated structures to aid in the filling and / or manufacturing steps. Improper handling can also pose a potential risk to the patient. This is particularly problematic in the semi-automated or automated manufacturing of BAOs for treating retinal disorders. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent No. 7,115,257 [Patent Document 2] U.S. Patent No. 6,361,771 [Patent Document 3] U.S. Patent No. 9,265,814 [Patent Document 4] U.S. Patent No. 10,195,140 Summary of the Invention

[0004] In some embodiments of the present disclosure, a medical device system is provided, which includes a medical device and / or, in some embodiments, an implantable analyte diffusive device (ADID) having a cavity, a cell scaffolding material (CSM) configured to hold or otherwise retain a plurality of viable cells arranged within the cavity, and a porous membrane at least partially surrounding the cavity, at least a portion of the membrane being adhered to the CSM by a high-hardness adhesive that creates a hemispherical seal at opposite ends of the membrane. The system also includes a fill port having a docking means at a first end and a micro-diameter tubing (MDT) extending from a second end. The MDT is sealed to the fill port at its distal end and to the ADID at its proximal end, thereby establishing an integral cell-filling pathway therein.

[0005] In such embodiments, at least one (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 fill port is (or includes, comprises) a temporary fill port; - at least one anchor arranged on at least one end of the device; The anchor is configured to attach the device to tissue; The anchor is configured to be retained by a clip, the clip being configured to allow packaging and / or transport of the device; and a clip, said clip may include at least one (or several or all) of the following: a first jaw having a corresponding first distal jaw end; a second jaw having a corresponding second distal jaw end configured to move relative to the first jaw end; · First jaw extension integral with the first jaw; a second jaw extension integral with the second jaw; and / or · at least two proximal extensions integral with the first jaw; The first extension may include any or all of a first protrusion, a first receiving area, and a second receiving area; The second extension may include a flexible protrusion; The first receiving area may be configured to receive one end of the flexible protrusion; The second receiving area may be configured to receive and move within the second jaw extension; The first distal end of the first jaw is closable against the second distal end of the second jaw in the rest position.

[0006] In some embodiments, an analyte diffusion system is provided, the analyte diffusion system comprising a medical device, and / or in some embodiments, an implantable analyte diffusion device (ADID) comprising: a cavity; a cell scaffold material (CSM) arranged within the cavity and configured to hold or otherwise retain a plurality of viable cells; a porous membrane at least partially surrounding the cavity, at least a portion of the membrane being adhered to the CSM by a high hardness adhesive that creates a hemispherical seal at each end of the membrane; and a fill port configured to connect to one end of the device, the port configured as a polymeric molded structure such that the port is fluidly connected to and sealed to the cavity, providing access to the cavity for cells to be received within the cavity and allowing an injection system to seal thereto.

[0007] 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 form further embodiments: - a micro-diameter tube (which in some embodiments can also be a larger sized "tube") having an internal micro-sized lumen (for example) configured to flow cells from the injection system into the cavity; the first end of the tube is configured to connect to one end of the implantable device; The second end of the tube is configured to connect to the port assembly; Cells are delivered from the injection system into the cavity through tubing from the port assembly; - the tube can include a wall thickness and / or material configured to maintain a diametric shape for delivery of cells through the tube and to maintain a diametric shape at a filling pressure of 0 to 150 psi (for example); -The tube is first sealed to the port assembly with adhesive; - the tube is sealed within the CSM and membrane with a second adhesive having different properties relative to the properties associated with the first adhesive; the tube is configured to preferentially release from the first adhesive; - the force required to preferentially disengage the sealed fill port from within the device is between 1 and 50 Newtons (for example); - the filling of the cells in the cavity is selected from the group consisting of capillary action, positive displacement, vacuum, servo-driven, peristaltic action and combinations thereof; -clip The clip is configured to allow packaging and / or transport of the device and includes at least one (and in some embodiments a plurality thereof, and in some embodiments all) of the following: · Proximal and distal ends; a first jaw having a corresponding first distal jaw end; a second jaw having a corresponding second distal jaw end configured to move relative to the first jaw end; · First jaw extension integral with the first jaw; a second jaw extension integral with the second jaw, and / or; · at least two proximal extensions integral with the first jaw; the first extension includes a first protrusion, a first receiving area, and a second receiving area; the second extension includes a flexible protrusion; the first receiving area is configured to receive one end of the flexible protrusion; the second receiving area is configured to receive and move within the second jaw extension; The first distal end of the first jaw is closed against the second distal end of the second jaw in the rest position.

[0008] In such an embodiment, a cell transfer method for transferring cells into a sample diffusion device is provided, the method including providing a sample diffusion system according to any of the present disclosure, sealing a tube with the device and a port assembly, transferring cells into the device through the port assembly and the tube using an injection system, wherein the transferred cells are stored in a CSM within the cavity, and removing at least one of the port assembly and the tube from the device.

[0009] In some embodiments, a sterile transfer method for transporting or otherwise transferring an implantable device is provided, the method including providing an implantable analyte diffusion device (ADID), providing a clip, holding the device with the clip, wherein the clip is attached to the device at one end of the device or via an anchor attached to one end of the device, and transferring the device via the clip by operation of an automated manufacturing unit to fill the device.

[0010] In some embodiments, a method for maintaining device orientation during storage and use for surgical implants is provided, the method comprising: providing a specimen diffusion system including an implantable specimen diffusion device (ADID); providing a clip; holding the ADID with the clip, wherein the clip is attached to the ADID at one end of the ADID or via an anchor attached to one end of the ADID, and holding the ADID vertically and centrally oriented in a packaging system containing a cell nutrient medium; and optionally, aseptically transporting the ADID from the packaging system to a sclerotomy incision, facilitating placement of the ADID in the incision and its removal from the vitreous cavity.

[0011] 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]

[0012] [Figure 1] FIG. 1 is an assembly view of a retention system for loading, holding, and / or retaining a biomedical implant, according to some embodiments of the present disclosure.

[0013] [Figure 2] 2 is an enlarged side view of an implant and clip for the system of FIG. 1 according to some embodiments of the present disclosure.

[0014] [Figure 3A] FIG. 3A is an enlarged side cross-sectional view of an implant and anchor of an assembly according to some embodiments of the present disclosure.

[0015] [Figure 3B] FIG. 3B is an assembly view of a retention system for loading, holding, and / or retaining a biomedical implant, according to some embodiments of the present disclosure.

[0016] [Figure 4] FIG. 4 is a perspective view of an implant anchor for assembly according to some embodiments of the present disclosure.

[0017] [Figure 5A] FIG. 5A is a side view of a clip of the assembly according to some embodiments of the present disclosure.

[0018] [Figure 5B] FIG. 5B is a perspective view of the clip of FIG. 5A, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0019] 1-5B illustrate embodiments of the present disclosure. FIG. 1 is a first side view of a medical device system according to some embodiments, including an analyte diffusion implantable device (ADID) 110, which includes a cavity and a cellular scaffolding material (CSM) configured to carry or otherwise retain a plurality of living cells arranged within the cavity and configured (according to some embodiments) to secrete a therapeutic protein-based drug. The system also includes a porous hollow fiber membrane at least partially surrounding the cavity (see U.S. Patent Nos. 6,223,999; 6,223,999; 6,223,999; and 6,223,999, each of which is incorporated herein by reference in its entirety). At least a portion of the membrane is adhered to the CSM at one end, and preferably both ends, of the membrane (e.g., for some embodiments), preferably with a high-hardness adhesive capable of creating a hemispherical seal. Also included is a fill port 120 (which in some embodiments may be referred to as a fill port assembly) having a docking means 130 (sometimes referred to as a port assembly) at a first end and a micro-diameter tubing (MDT) 140 extending from a second end. The MDT is sealed (and preferably hermetically sealed) to the fill port 120 at a distal end 142 and to the cavity of the ADID 110 at a proximal end 144 to establish an integral cell loading pathway therein.

[0020] In some embodiments, the ADID / system 110 includes at least one anchor 112 arranged on at least one end of the device, which can be configured to attach the device 110 to (for example) tissue. The anchor 112 can also be configured to be received by and / or retained by a clipping device 150 (clip). The clip 150 can be configured to allow for packaging and / or transport of the ADID.

[0021] In such embodiments, the fill port 120 is (or includes or comprises) a temporary fill port that is used only to fill the ADID, after which it has no further use and can be removed / discarded / reused. The at least one anchor (in some embodiments), which can be multiple anchors, is arranged on at least one end of the device and configured to attach the device to tissue. Figures 2-4 show various views of at least one anchor and an ADID according to some embodiments. Specifically, Figure 2 shows an enlarged second side view of the combined attachment of the clip device 150, at least one anchor, and ADID, where the at least one anchor is configured to be retained by the clip device to enable packaging and / or transport of the device in some embodiments.

[0022] As shown in Figures 3A-B and 4, at least one anchor can be a loop that can include a metal or a polymer (or a combination thereof), and multiple anchors of this configuration can be used to couple to ADID 110 (and one or more can be used to secure ADID to tissue; in some embodiments, one leg of the loop configuration can be considered at least one anchor). In some embodiments, at least one anchor can include a loop configuration (Figures 2A-2D), which can include a spherical end or sphere 112a, which is coupled to an internal structure 110a within ADID 110 (cross-sectional view in Figure 3B).

[0023] 5A-B, at least one anchor can be configured to be retained by a clip 150, which can include a proximal end 150-1 and a distal end 150-2, a first jaw 150-4 having a corresponding first distal jaw end 150-4a, and a second jaw 150-6 having a second distal jaw end 150-6a configured to move relative to the first jaw end. The anchor can also include a first jaw extension 150-10 that can be integral with the first jaw 150-4, a second jaw extension 150-8 that is integral with the second jaw 150-6, and at least two proximal extensions 150-12a, 150-12b that are integral with the first jaw 150-4.

[0024] In some embodiments, in this configuration, the first jaw extension 150-10 can include a first protrusion 150-10a, a first receiving area 150-10b, and a second receiving area 150-10c, the second extension 150-8 can include a flexible protrusion 150-8a, the first receiving area 150-10b can be configured to receive one end of the flexible protrusion 150-8a, the second receiving area 150-10c can be configured to receive and move within the second jaw extension 150-8, and / or the first distal end 150-4a of the first jaw 150-4 can close against the second distal end 150-6a of the second jaw 150-6 in (for example) a rest position.

[0025] In some embodiments, a system for analyte diffusion is provided, the system including an implantable analyte diffusion device (ADID) including a cavity, a cell scaffolding material (CSM) configured to hold or otherwise retain a plurality of living cells arranged within the cavity, and a porous membrane at least partially surrounding the cavity, at least a portion of the membrane being adhered to the CSM by a high-hardness adhesive that creates a hemispherical seal at each end of the membrane, the system including a fill port configured to connect to one end of the device, the port being fluidly connected to and sealed to the cavity, providing access to the cavity for cells to be received in the cavity, and configured as a polymeric molded structure to allow an injection system to seal thereto.

[0026] In such embodiments, the micro-diameter tube 140 includes an internal micro-sized lumen configured to flow cells from an injection system into the cavity. Specifically, in some embodiments, the internal dimension of the associated lumen is approximately 50-500 μm, and in some embodiments, preferably 100-150 μm. The tube includes a wall thickness and / or material configured to maintain a diametric shape for delivery of cells therethrough and to maintain a diametric shape at a fill pressure of (e.g.) 0-150 psi, and the tube 140 can be sealed to the port assembly with a first adhesive (or other means known to those skilled in the art). The tube 140 can be sealed within the CSM and membrane with (e.g.) a second adhesive (in some embodiments) having properties different from those associated with the first adhesive.

[0027] A first end 140-2 of the tube 140 is configured to connect to one end 110-2 of the ADID 110, and a second end 140-4 of the tube is configured to connect to the port assembly 130, such that cells are delivered from the injection system into the cavity of the ADID through the port assembly and through the tube 140. In some embodiments, the tube 140 is configured to preferentially detach from the first adhesive (e.g., holding the tube 140 to the port assembly 130), and the force required to preferentially detach the sealed tube 140 from within the device is, in some embodiments, between 1 and 100 Newton-meters, and in some embodiments, preferably between 30 and 35 Newton-meters.

[0028] The loading of cells into the cavity of ADID 110 can be by any one or more of capillary action, positive displacement, vacuum, servo-driven, peristaltic action, and combinations thereof.

[0029] In some embodiments, a cell transfer method is provided for transferring cells into an analyte diffusion device or any medical device or the like, the method can include, for example, in some embodiments, providing an analyte diffusion system, for example, according to any of the disclosed embodiments (e.g., described above), and sealing a tube with the ADID device and port assembly 130. The method can further include transferring the cells into the device via the port assembly 130 and the tube 140, for example, using an injection system. In some embodiments, the transferred cells are stored on / in a CSM within a cavity of the ADID 110, and at least one of the port assembly 130 and the tube is removed from the ADID 110.

[0030] Further, in some embodiments, a sterile transfer method for transporting or otherwise transferring an implantable device (or any medical device or other therefor) is provided, the method comprising providing an analyte diffusion implantable device (ADID), providing a clip, holding the device with the clip, wherein the clip is attached to the device at one end of the device or via an anchor attached to one end of the device, and transferring the device through the clip by operation of an automated manufacturing unit to fill the device.

[0031] In some embodiments, a sterile method for maintaining device orientation during storage and / or use for a surgical implant (or any medical device or other), includes providing a specimen diffusion system (or any medical or other device therefor) including an implantable specimen diffusion device (ADID), providing a clip, holding the ADID with the clip, wherein the clip is attached to the ADID at one end of the ADID or via an anchor attached to one end of the ADID, and holding the ADID vertically and centrally in a packaging system containing cell nutrient medium, and optionally aseptically transferring the ADID from the packaging system to a sclerotomy incision to facilitate placement of the ADID in the incision and its removal from the vitreous cavity.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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."

[0036] 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).

[0037] 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.

[0038] 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).

[0039] 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 medical device system, comprising: 1. An analyte diffusion implantable device (ADID), comprising: Cavity and a cellular scaffolding material (CSM) arranged within the cavity and configured to carry or otherwise retain a plurality of living cells; a porous membrane at least partially surrounding the cavity, at least a portion of the membrane being adhered to the CSM by a hard adhesive that creates a hemispherical seal at each end of the membrane; an implantable device for analyte diffusion, comprising: A fill port, docking means at a first end; a micro-diameter tube (MDT) extending from the second end; the MDT is sealed at its distal end to the loading port and at its proximal end to the cavity of the ADID to establish an integral cell loading pathway therein; A fill port; A system comprising: [Aspect 2] 2. The system of embodiment 1, wherein the fill port comprises a temporary fill port. [Aspect 3] 3. The system of any one of aspects 1 to 2, further comprising at least one anchor arranged on at least one end of the device. [Aspect 4] 4. The system of embodiment 3, wherein the anchor is configured to attach the device to tissue. [Aspect 5] 5. The system of any one of aspects 3 to 4, wherein the anchor is configured to be held by a clip. [Aspect 6] A system as described in aspect 5, wherein the clip is configured to allow packaging and / or transport of the device. [Aspect 7] The clip is a proximal end and a distal end; a first jaw having a corresponding first distal jaw end; a second jaw having a corresponding second distal jaw end configured to move relative to the first jaw end; a first jaw extension integral with the first jaw; a second jaw extension integral with the second jaw; at least two proximal extensions integral with the first jaw; Equipped with the first extension includes a first protrusion, a first receiving area, and a second receiving area; the second extension includes a flexible protrusion; the first receiving area is configured to receive one end of the flexible protrusion; the second receiving area is configured to receive and move within the second jaw extension; a first distal end of the first jaw closed against a second distal end of the second jaw in a rest position; 7. The system according to embodiment 5 or 6. [Aspect 8] 1. A system for analyte diffusion, comprising: An implantable analyte diffusion device (ADID), comprising: Cavity and a cellular scaffolding material (CSM) arranged within the cavity and configured to carry or otherwise retain a plurality of living cells; a porous membrane at least partially surrounding the cavity, at least a portion of the membrane being adhered to the CSM by a hard adhesive that creates a hemispherical seal at each end of the membrane; an implantable analyte diffusion device comprising: a fill port configured to connect to one end of the device, the port comprising: a fluidly connected to and sealed to said cavity; providing access to the cavity to allow cells to be received within the cavity; As a polymer molded structure, allowing the injection system to seal to it; a fill port configured to A system comprising: [Aspect 9] 9. The system of embodiment 8, further comprising a micro-diameter tube having a lumen with a micro-sized interior configured to flow cells from an injection system into the cavity. [Aspect 10] a first end of the tube configured to connect to one end of the implantable device; a second end of the tube configured to connect to a port assembly; cells are delivered from the injection system into the cavity through the port assembly and through the tube; 10. The system according to embodiment 9. [Aspect 11] 11. The system of claim 9 or 10, wherein the tube comprises a wall thickness and / or material configured to maintain a diametric shape for delivering cells through the tube and to maintain the diametric shape at a filling pressure of 0 to 150 psi. [Aspect 12] The system of any one of aspects 9-11, wherein the tube is sealed to the port assembly with a first adhesive. [Aspect 13] A system described in any of embodiments 9 to 11, wherein the tube is sealed within the CSM and the membrane with a second adhesive having properties different from the properties associated with the first adhesive described in embodiment 12. [Aspect 14] The system of any of aspects 9 to 13, wherein the tube is configured to preferentially detach from a first adhesive comprising the device of aspect 13. [Aspect 15] 15. The system of any one of aspects 9-14, wherein the force required to preferentially disengage the sealed fill port from within the device is 1 to 50 Newtons. [Aspect 16] 16. The system of any one of aspects 8 to 15, wherein the filling of cells into the cavity is selected from the group consisting of capillary action, positive displacement, vacuum, servo-driven, peristaltic action, and combinations thereof. [Aspect 17] The system according to any one of Aspects 8 to 16, further comprising a clip. [Aspect 18] 18. The system of embodiment 17, wherein the clip is configured to allow packaging and / or transport of the device. [Aspect 19] 19. The system of claim 17 or 18, The clip is a proximal end and a distal end; a first jaw having a corresponding first distal jaw end; a second jaw having a corresponding second distal jaw end configured to move relative to the first jaw end; a first jaw extension integral with the first jaw; a second jaw extension integral with the second jaw; at least two proximal extensions integral with the first jaw; Equipped with the first extension includes a first protrusion, a first receiving area, and a second receiving area; the second extension includes a flexible protrusion; the first receiving area is configured to receive one end of the flexible protrusion; the second receiving area is configured to receive and move within the second jaw extension; the first distal end of the first jaw is closed against the second distal end of the second jaw in a rest position; system. [Aspect 20] 1. A cell transfer method for transferring cells into an analyte diffusion device or system, the method comprising: providing a system for analyte diffusion according to any one of aspects 1 to 19; sealing the tube with the instrument and port assembly; transferring cells into the device through the port assembly and tubing using the injection system; The transferred cells are stored in the CSM within the cavity. To transport and removing at least one of the port assembly and tubing from the device; A method comprising: [Aspect 21] 1. A sterile transfer method for transporting or otherwise transferring an implantable device or system, said method comprising: Providing an implantable specimen diffusion device (ADID); Prepare the clips and holding the device with the clip, the clip being attached to the device at one end of the device or via an anchor attached to the end of the device; transferring the device through the clip by operation of an automated manufacturing unit to fill the device; A method comprising: [Aspect 22] 1. A sterile method for maintaining the orientation of an instrument or system during storage and use for surgical implantation, said method comprising: providing a system for analyte diffusion including an implantable analyte diffusion device (ADID); Prepare the clips and holding the ADID with the clip, the clip being attached to the ADID at one end of the ADID or via an anchor attached to the end of the ADID to hold the ADID vertically and centrally in a packaging system containing a cell nutrient medium; Optionally, sterilely transferring the ADID from the packaging system to a sclerotomy incision to facilitate placement of the ADID into the incision and vitreous cavity and removal of the ADID; A method comprising: [Aspect 23] A system, apparatus, device or method according to any of the disclosed embodiments.

Claims

1. A medical device system (100), comprising: An analyte diffusion implantable device ADID (110), comprising: Cavity and a cellular scaffold material (CSM) arranged within the cavity and configured to hold or retain a plurality of living cells; a porous membrane at least partially surrounding the cavity, at least a portion of the porous membrane being adhered to the CSM by a hard adhesive that creates a hemispherical seal with the porous membrane; an implantable device for analyte diffusion, ADID (110), comprising: A fill port (120) having a proximal end and a distal end, a docking means (130) having a distal end connected to the proximal end of the filling port; a micro-diameter tube MDT (140), the distal end of which is connected to the proximal end of the docking means (130), and the proximal end of which is connected to the device ADID (110); the fill port (120) having at least one anchor (112) arranged on at least one end of said device ADID (110); a clip (150) for holding the anchor; Equipped with the micro-diameter tube MDT (140) is sealed at the distal end to the proximal end of the docking means (130) and at the proximal end to the cavity of the device ADID (110) to establish an integral cell loading pathway therein; The clip is a proximal end (150-1) and a distal end (150-2); a first jaw (150-4) having a corresponding first distal jaw end (150-4a); a second jaw (150-6) having a corresponding second distal jaw end (150-6a) and configured to move relative to the first distal jaw end (150-4a); a first jaw extension (150-10) integral with said first jaw (150-4); a second jaw extension (150-8) integral with said second jaw (150-6); at least two proximal extensions (150-12a) (150-12b) integral with said first jaw (150-4); Equipped with the first distal jaw end (150-4a) of the first jaw (150-4) is closed against the second distal jaw end (150-6a) of the second jaw (150-6) in a rest position; system.

2. The system of claim 1 , wherein the fill port comprises a temporary fill port.

3. The system of claim 1 , wherein the anchor (112) is configured to attach the device ADID (110) to tissue.

4. The system of claim 1 , wherein the clip (150) is configured to allow packaging and / or transport of the device ADID (110).

5. the first jaw extension (150-10) includes a first protrusion (150-10a), a first receiving area (150-10b), and a second receiving area (150-10c); the second jaw extension (150-8) includes a flexible protrusion (150-8a); the first receiving area (150-10b) is configured to receive one end of the flexible protrusion; the second receiving area (150-10c) is configured to receive the second jaw extension (150-8) and move the second jaw extension (150-8) therein; The system of claim 1 .

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