Pouch and pouch fitting comprising a rigid

Abstract

A fitting for a bag includes an integrally formed lancet port including an aperture, a puncture barrier film, and an inner gasket. The accessory may be a fluoropolymer. The puncture barrier layer may be a fluoropolymer film. The inner gasket is positioned within the aperture and provides an additional puncture barrier for the lancet port. The accessory can be incorporated into a bag by joining two sheets, such as fluoropolymer sheets, to each other around the perimeter of the sheets and to the accessory. The pouch may be used in processes including exposure to or maintained at cryogenic temperatures.

Description

Technical Field

[0001] The present disclosure relates to a bag containing a fluoropolymer fitting, the fluoropolymer fitting including a needle port. Background Art

[0002] Medical bags can include a needle port that is directly welded to a sheet used to form the bag to provide fluid transfer from the bag. Cell and gene therapy bags typically use traditional medical bags and corresponding fluid transfer methods, such as for administration in a clinical setting. Summary of the Invention

[0003] The present disclosure relates to a bag containing a fluoropolymer fitting, the fluoropolymer fitting including a needle port.

[0004] By integrally incorporating a needle port with a fitting for the bag and joining a sheet to the fitting to form the bag, a bag containing a needle port for fluid transfer can be provided, while also providing a bag suitable for applications involving exposure to or retention at low temperatures (e.g., during handling of the contents of the bag).

[0005] In an embodiment, a fitting for a bag includes a fitting body and a needle port. The fitting body includes a first sidewall and a second sidewall, each of the first sidewall and the second sidewall extending between opposite endpoints, and the fitting body includes a fluoropolymer material. The needle port includes a needle port body. The needle port body is integrally formed with the fitting body, and the needle port body includes an orifice configured to receive a needle. The needle port further includes a first puncture barrier layer including a fluoropolymer film and an internal gasket disposed within the needle port body. The internal gasket is configured to provide a second puncture barrier layer.

[0006] In an embodiment, the internal gasket includes silicone, a thermoplastic elastomer, a fluoropolymer, ethylene vinyl acetate, or a combination thereof.

[0007] In an embodiment, the diameter of the orifice is in the range from 0.18 inches (about 4.5 mm) to 0.22 inches (about 5.6 mm).

[0008] In an embodiment, the fitting further includes an additive port integrally formed with the fitting body.

[0009] In an embodiment, the first puncture barrier layer is joined to one end of the needle port body by welding, and the first puncture barrier layer covers the orifice.

[0010] In an embodiment, the first puncture barrier layer is disposed within the orifice.

[0011] In an embodiment, an inner surface of the lancet port body includes an annular protrusion and an outer surface of the inner gasket includes an annular groove.

[0012] In an embodiment, the orifice has a first diameter in a first portion of the lancet port body and a second diameter less than the first diameter in a second portion of the lancet port body, and the inner gasket has an outer diameter less than the first diameter and greater than the second diameter.

[0013] In an embodiment, the inner surface of the lancet port body includes one or more first engagement features and the inner gasket includes one or more second engagement features configured to engage the first engagement features.

[0014] In an embodiment, a pouch further includes a first fluoropolymer sheet and a second fluoropolymer sheet. A first portion of a perimeter of the first fluoropolymer sheet is welded to a first portion of a perimeter of the second fluoropolymer sheet, a second portion of the perimeter of the first fluoropolymer sheet is welded to the fitting, and a second portion of the perimeter of the second fluoropolymer sheet is welded to the fitting. The first portion of the perimeter of the first fluoropolymer sheet and the second portion of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet. The first portion of the perimeter of the second fluoropolymer sheet and the second portion of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet.

[0015] In an embodiment, a method includes providing a fitting that includes a fitting body having a first sidewall and a second sidewall, each of the first sidewall and the second sidewall extending between opposite end points, the first sidewall and the second sidewall defining a central opening, the fitting body including a fluoropolymer material and a lancet port body integrally formed with the fitting body, the lancet port body including an orifice configured to receive a lancet, the fitting including a fluoropolymer. The method further includes installing an inner gasket into the lancet port body and welding a fluoropolymer film to the fitting to provide a puncture barrier layer.

[0016] In an embodiment, the method further comprises: providing a first fluoropolymer sheet; providing a second fluoropolymer sheet; welding a first portion of the perimeter of the first fluoropolymer sheet to a first portion of the perimeter of the second fluoropolymer sheet; and welding a second portion of the perimeter of the first fluoropolymer sheet and a second portion of the second fluoropolymer sheet to the fitting. The first portion of the perimeter of the first fluoropolymer sheet and the second portion of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet, and the first portion of the perimeter of the second fluoropolymer sheet and the second portion of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet.

[0017] In an embodiment, the inner gasket comprises silicone or ethylene vinyl acetate.

[0018] In an embodiment, the diameter of the orifice is in the range from 0.18 inches to 0.22 inches.

[0019] In an embodiment, the fluoropolymer film is joined to one end of the lancet port body and covers the orifice.

[0020] In an embodiment, the fluoropolymer film is disposed within the lancet port body.

[0021] In an embodiment, the inner surface of the lancet port body includes an annular protrusion and the outer surface of the inner gasket includes an annular groove, and installing the inner gasket includes positioning the inner gasket such that the annular protrusion is received within the annular groove.

[0022] In an embodiment, the orifice has a first diameter in a first portion of the lancet port body and a second diameter less than the first diameter in a second portion of the lancet port body, and the inner gasket has an outer diameter less than the first diameter and greater than the second diameter, and installing the inner gasket includes inserting the inner gasket from the first portion of the lancet port body into the orifice.

[0023] In an embodiment, the inner surface of the lancet port body includes one or more first engagement features and the inner gasket includes one or more second engagement features, the one or more second engagement features being configured to engage with the first engagement features, and installing the inner gasket includes engaging the one or more first engagement features with the one or more second engagement features.

[0024] In an embodiment, a method of practicing a process includes: providing a bag according to an embodiment herein; adding a process fluid to the bag; bringing the bag to a temperature of -80 °C or lower; and inserting a lancet into an orifice of a lancet port. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 A perspective view of a fitting according to an embodiment is shown.

[0026] Figure 2 A cross-sectional view of a fitting according to an embodiment is shown.

[0027] Figure 3A A cross-sectional view of a lancet port according to an embodiment is shown.

[0028] Figure 3B A cross-sectional view of a lancet port according to an embodiment is shown.

[0029] Figure 3C A cross-sectional view of a lancet port according to an embodiment is shown.

[0030] Figure 3D A cross-sectional view of a lancet port according to an embodiment is shown.

[0031] Figure 4 A bag according to an embodiment is shown.

[0032] Figure 5 A method of manufacturing a bag according to an embodiment is shown.

[0033] Figure 6 A method of using a bag according to an embodiment is shown. DETAILED DESCRIPTION

[0034] The present disclosure relates to bags that include fluoropolymer fittings that include lancet ports.

[0035] Figure 1 A perspective view of a fitting according to an embodiment is shown. Fitting 100 includes a fitting body 102 having a first sidewall 104 and a second sidewall 106. Each of the first sidewall 104 and the second sidewall 106 converges at opposite end points 108. A lancet port 110 is integrally formed with the fitting body 102. The lancet port 110 includes a lancet port body 112, an end 114, an orifice 116, and a puncture barrier membrane 118. An internal gasket (not shown) may be included within the lancet port body 114.

[0036] The fitting 100 is a fitting configured to be attached to a flexible sheet such as a fluoropolymer sheet to form a bag that includes the fitting 100. The fitting 100 is configured to provide one or more ports that allow for communication between the interior space of the bag and the exterior of the bag. The fitting 100 can be a single unitary piece in which all features are integrally formed, or it can be assembled from multiple pieces that are fixed to each other, for example, using one or more welds. The fitting 100 can comprise any suitable material, such as a fluoropolymer. In an embodiment, the entire fitting 100 is formed of a fluoropolymer. In an embodiment, the fluoropolymer can comprise one or more of an ethylene tetrafluoroethylene (ETFE) polymer, a polychlorotrifluoroethylene (PCTFE) polymer, a polyvinyl fluoride (PVF) polymer, a polyvinylidene fluoride (PVDF) polymer, and the like. In an embodiment, the fluoropolymer is ETFE.

[0037] The fitting 100 includes a first sidewall 104 and a second sidewall 106. The first sidewall 104 and the second sidewall 106 meet at opposite end points 108. One or both of the first sidewall 104 and the second sidewall 106 can be curved. In an embodiment, one or both of the first sidewall 104 and the second sidewall 104 can include one or more concave sections. In an embodiment, one or both of the first sidewall 104 and the second sidewall 106 can include convex sections. The first sidewall 104 and the second sidewall 106 can provide a "boat" shape for the fitting 100. Each of the first sidewall 104 and the second sidewall 106 provides an outer surface that is configured to allow attachment of a sheet such as a fluoropolymer sheet, such that the fitting 100 can be included in a bag. The first sidewall 104 and the second sidewall 106 can be shaped such that the first sidewall 104 and the second sidewall 106 provide an attachment surface that allows for continuous attachment of a sheet or film, and a smooth transition from where the sheets are attached to each other to where the sheets are attached to the first sidewall 104 or the second sidewall 106. In an embodiment, the first sidewall 104 and the second sidewall 106 can define a central opening that is configured to communicate with the interior space of the bag that is formed by attaching a sheet or film to the fitting 100. The sidewalls 104, 106 can be shaped in accordance with the disclosure of U.S. Patent Application No. 16 / 257,921, which is incorporated herein by reference in its entirety.

[0038] A lancet port 110 is provided in the fitting 100. The lancet port is configured to receive a lancet such that the lancet can be placed in communication with the interior space of the pouch that includes the fitting 100. The lancet port 110 includes a lancet port body 112 that extends from the fitting 100 to an end 114. The end 114 is positioned such that when the pouch formed using the fitting 100 is formed, the end 114 is disposed outside of the pouch. The lancet port body 112 can be integrally formed with other components of the fitting 100, such as a first sidewall 104 and a second sidewall 106. The lancet port body includes an aperture 116 that extends from the end 114 through the lancet port body 112 such that the aperture 116 can provide communication between the interior spaces of the pouch formed using the fitting 100. In an embodiment, the aperture 116 can be connected to a central opening defined by the fitting 100 (e.g., defined between the first sidewall 104 and the second sidewall 106). In an embodiment, the aperture 116 is through the entirety of the fitting 100. The aperture 116 is sized such that any suitable lancet can be inserted into the lancet port 110 such that fluid can be added to or removed from the pouch formed using the fitting 100. The aperture 116 can be sized to accommodate use with one or more different types of lancets. In an embodiment, the aperture 116 is sized independent of manufacturer variation or lancet size within a defined range. In an embodiment, the inner diameter of the aperture 116 is in the range from 0.18 inches to 0.22 inches. An inner gasket (not shown) can be provided within the lancet port body 112, within the aperture 116, for example as described below and Figure 2 and 3A as shown in 3C.

[0039] A piercing barrier membrane 118 can be provided to seal the aperture 116 prior to insertion of the lancet. The piercing barrier membrane 118 can be provided over the opening of the aperture 116 at the end 114 or can be provided within the aperture 116. The piercing barrier membrane 118 can be a polymeric membrane of any suitable polymer. In an embodiment, the piercing barrier membrane 118 is a fluoropolymer membrane. In an embodiment, the piercing barrier membrane 118 is a membrane of the same fluoropolymer as the fluoropolymer included in the lancet port body 112. In an embodiment, the piercing barrier membrane 118 is a fluoropolymer membrane used in the fluoropolymer sheet used to form the pouch that includes the fitting 100. The piercing barrier membrane 118 is joined to the lancet port body 112 by any suitable method, such as welding, e.g., heat welding.

[0040] Figure 2Shows a cross-sectional view of a fitting according to an embodiment. The fitting 200 includes a sidewall 202. The sidewall 202 partially defines a central opening 204. A cannula port 206 is joined to the sidewall 202. The cannula port 206 includes a cannula port body 208 in which an orifice 210 is formed. The orifice 210 includes a first end 212 and a second end 214. The first end 212 of the orifice 210 is connected to the central opening 204. The second end 214 of the orifice 210 is disposed at one end of the cannula port body 208. An internal gasket 216 is disposed within the orifice 210. A puncture barrier membrane 218 may be disposed at or near the second end 214 of the orifice 210. One or more additional ports 220 may optionally be included in the fitting 200, such as a port 220 having a hose barb fitting 222.

[0041] The fitting 200 is a fitting to which a polymer sheet may be joined to form a bag. The fitting 200 provides an attachment area to which the polymer sheet may be joined, and provides one or more ports, such as the cannula port 206 and optionally additional ports 220, to allow communication between the interior and exterior of the bag. The fitting 200 may be a single unitary piece in which all features are integrally formed, or may be assembled from multiple pieces that are fixed to each other, for example, using one or more welds. The fitting 200 may comprise any suitable material, such as a fluoropolymer. In an embodiment, the entire fitting 200 is formed of a fluoropolymer. In an embodiment, the fluoropolymer may comprise one or more of an ethylene tetrafluoroethylene (ETFE) polymer, a polychlorotrifluoroethylene (PCTFE) polymer, a polyvinyl fluoride (PVF) polymer, a polyvinylidene fluoride (PVDF) polymer, and the like. In an embodiment, the fluoropolymer is ETFE.

[0042] In Figure 2 the cross-sectional view, the sidewall 202 is visible. The sidewall 202 may be a sidewall that partially defines a portion of the fitting 200 to which a polymer sheet may be attached to form a bag. In an embodiment, the sidewall 202 is one of the first sidewall 104 or the second sidewall 106 as described above and Figure 1 shown in. In the fitting 200, the sidewall 202 partially defines a central opening 204. When a bag is formed by attaching a polymer sheet to the fitting 200, the central opening 204 is disposed on the side of the fitting 200 that faces the interior of the bag.

[0043] The lancet port 206 extends from the fitting 200. The lancet port 206 is a port configured to receive a lancet such that fluid can be added to or removed from the bag containing the fitting 200. The lancet port 206 includes a lancet port body 208. The lancet port body 208 defines an aperture 210. The aperture 210 is configured to receive a lancet such that the lancet can be placed in communication with the interior space of the bag containing the fitting 200. The lancet port body 208 can be integrally formed with other portions of the fitting 200 (such as the sidewall 202). The aperture 210 extends through the lancet port body 208 from a first end 212 to a second end 214. The first end 212 is positioned such that the first end 212 is disposed outside of the bag formed by joining a polymer sheet to the fitting 200. The second end 214 is configured such that it will be in communication with the interior space of the bag formed by attaching a polymer sheet to the fitting 200. In Figure 2 the illustrated embodiment, the second end 214 is in communication with the central opening 204. In alternative embodiments, the second end can be located on the side of the fitting 210 opposite the first end 212. In embodiments, the aperture 210 is sized to be independent of manufacturer variations or lancet sizes within a defined range. In embodiments, the inner diameter of the aperture 116 is in the range from 0.18 inches to 0.22 inches.

[0044] An inner gasket 216 is disposed within the aperture 210 of the lancet port 206. The inner gasket is configured to provide a puncture barrier layer prior to inserting a lancet into the aperture 210 and to hold the lancet once the lancet has been inserted or passed through the inner gasket 216. The puncture barrier layer provided by the inner gasket 216 can be a puncture barrier film 118 as described above and shown in Figure 1 or Figure 2The replenishment of a dedicated puncture barrier layer such as the puncture barrier film 218 provided in [the relevant context]. The inner gasket 216 can be a piece separated from the cannula port body 208. The inner gasket 216 can be held within the orifice 210 by any suitable connection (such as a mechanical connection, e.g., press fit, engagement of one or more engagement features, contact with one or more shoulders formed within the cannula port body 208, combinations thereof, etc.). The inner gasket 216 can be formed from any one or more suitable materials, non-limiting examples of suitable materials including silicone, ethylene vinyl acetate (EVA) polymer, thermoplastic elastomer, fluoropolymer, neoprene, etc. The material of the inner gasket 216 can have any suitable hardness. In an embodiment, the material of the inner gasket 216 has a Shore A hardness of up to 90. In an embodiment, the material of the inner gasket 216 has a Shore A hardness ranging from 50 to 90. In an embodiment, the material of the inner gasket 216 has a Shore A hardness ranging from 50 to 70. In an embodiment, the material of the inner gasket 216 has a Shore A hardness of approximately 70. The material of the inner gasket 216 can have any suitable glass transition temperature selected according to the conditions to which the inner gasket 216 will be subjected. In an embodiment, the glass transition temperature of the material of the inner gasket 216 can be -30 °C or lower. In an embodiment, the glass transition temperature of the material of the inner gasket 216 can be -125 °C or lower. In an embodiment, the glass transition temperature of the material of the inner gasket 216 can be -170 °C or lower.

[0045] The puncture barrier film 218 can be provided to close the orifice 210 before inserting the cannula. The puncture barrier film 218 can be provided above the first end 212 of the orifice 210 or can be provided within the orifice 210. The puncture barrier film 218 can be a polymer film of any suitable polymer. In an embodiment, the puncture barrier film 218 is a fluoropolymer film. The puncture barrier film 218 is joined to the cannula port body 208 by any suitable method (such as welding, e.g., heat welding).

[0046] The optional port 220 can be another port provided on the fitting 200 to allow communication between the interior and the exterior of a bag formed using the fitting 200. The port 220 can be any suitable port for providing this communication. In an embodiment, the port 220 can be a cannula port similar to or the same as the cannula port 208. In an embodiment, the port 220 can include another connection feature (e.g., as Figure 2The port of the hose barb 222) shown in. In an embodiment, the port 220 may communicate with the central opening 204. In an embodiment, the port 220 may extend through the fitting 200. In an embodiment, two or more of the optional ports 220 may be included. In an embodiment, the optional additional port 220 may include a hose barb connector 222. The hose barb connector 222 may include one or more protrusions (e.g., Figure 2 the conical protrusion shown in) extending outward from the port 220 such that the hose may stretch over the hose barb connector 222 and be held in place above the port 220 to facilitate the transfer of fluid into or out of the bag containing the fitting 200 when connecting the hose. In an embodiment, other suitable attachments may be provided at the port 220, such as a quick connect-disconnect system, a luer connection feature, a molded conduit, etc. As non-limiting examples, examples of such attachments include sterile connectors, such as the sterile connectors according to U.S. Provisional Application Nos. 63 / 255,581 and 63 / 297,148, which are incorporated herein by reference in their entireties. In embodiments including more than one optional additional port 222, the connectors provided at the respective ports 220 may all be of the same type of connector or may be of different types of connectors.

[0047] Figure 3A A cross-sectional view of a stylet port according to an embodiment is shown. The stylet port 300 includes a stylet port body 302 having an inner surface 304. An annular protrusion 306 extends from the inner surface 304. The inner gasket 308 includes an outer surface 310. An annular groove 312 is formed in the outer surface 310 of the gasket 308. In an embodiment, one or both of the annular protrusion 306 and the annular groove 312 are continuous around the circumference of the inner surface 304 or the outer surface 310, respectively. In an embodiment, one or both of the annular protrusion 306 and the annular groove 312 include one or more discontinuous portions relative to the circumference of the inner surface 304 or the outer surface 310. The inner gasket 308 may be installed in the stylet port 300 by inserting the inner gasket 308 into the space defined by the inner surface 304 until the annular protrusion 306 is received in the annular groove 312. The inner gasket 308 may be configured such that the outer surface 310 forms a press fit with the inner surface 304 of the stylet port body 302. A puncture barrier membrane 314 may be provided at or near the end of the stylet port body 302.

[0048] Figure 3BShows a cross-sectional view of a lancet port according to an embodiment. The lancet port 320 includes a lancet port body 322, which includes a first section 324 having a first inner diameter and a second section 326 having a second inner diameter. The first inner diameter is greater than the second inner diameter. The first inner diameter and the second inner diameter can each be sized such that a lancet can be received through an inner gasket 334 such that the lancet can provide fluid communication through the lancet port 320 including the inner gasket 334. A shoulder 328 can be provided at the location where the lancet port body 322 transitions from the first section 324 to the second section 326. The first section 324 having the first inner diameter can face the end 330 where the puncture barrier membrane 332 is provided. The second section 326 can be connected to a central opening of a fitting that includes the lancet port 320, such as the central opening 110 described above and Figure 1 shown in. The inner gasket 334 can be included in the lancet port 320. The inner gasket 334 can be sized such that it can be inserted into the lancet port body 322 at the first section 324 and held at the shoulder 328. For example, the inner gasket 334 can have an outer diameter that is equal to or less than the first inner diameter and greater than the second inner diameter. The inner gasket 334 can be installed in the lancet port 320 by inserting the inner gasket 334 into the first section 324 until the inner gasket 334 contacts the shoulder 328 to seat the inner gasket 334. After inserting the inner gasket 334 and seating it against the shoulder 328, the puncture barrier membrane 332 can be joined to the lancet port 320 at or near the end 330. A retainer 336 can be provided to hold the inner gasket 334 in place.

[0049] Figure 3CShows a cross-sectional view of a lancet port according to an embodiment. The lancet port 340 includes a lancet port body 342, the lancet port body including a first section 344 having a first inner diameter and a second section 346 having a second inner diameter. The first inner diameter and the second inner diameter may each be sized such that a lancet can be received through an inner gasket 350 such that the lancet can provide fluid communication through the lancet port 340 including the inner gasket 350. One or more lancet port body engagement features 348 may be provided on the inner surface of the lancet port body, in one or both of the first section 344 and the second section 346, or in a transition region between the first section 344 and the second section 346. The inner gasket 350 may have an outer diameter that is equal to or less than the first inner diameter and greater than the second inner diameter. The inner gasket 350 may include one or more inner gasket engagement features 352 configured to engage the lancet port body engagement features 348. The inner gasket engagement features 352 and the lancet port body engagement features 348 may be any suitable pair of corresponding engagement features, such as corresponding tabs, protrusions, pawls, etc. and corresponding depressions, recesses, grooves, etc. When the inner gasket 350 is positioned within the lancet port body 342, the inner gasket engagement features may be configured to hold the inner gasket 350 in place. In an embodiment, the inner gasket engagement features 352 and the lancet port body engagement features 348 are configured such that their engagement prevents rotation of the inner gasket 350 relative to the lancet port body 342. In an embodiment, the inner gasket engagement features 352 and the lancet port body engagement features 348 are configured such that their engagement prevents translational movement of the inner gasket within the first section 344 of the lancet port body 342 such that the inner gasket does not slide within the lancet port body 342 or disengage from the lancet port body. The inner gasket may be installed in the lancet port 340 by inserting the inner gasket 350 into the first section 344 of the lancet port body and pressing the inner gasket 350 and optionally rotating the inner gasket 350 such that the inner gasket engagement features 352 engage the lancet port body engagement features 348. A puncture barrier film 354 may be provided at one end of the lancet port 340. A retainer 356 may be provided to hold the inner gasket 350 in place.

[0050] Figure 3D Shows a cross-sectional view of a lancet port according to an embodiment. The lancet port 360 includes a lancet port body 362 defining an aperture 364. An inner gasket 366 is disposed within the aperture 364 and is integrally formed with the lancet port body 362. In Figure 3DIn the embodiments shown, the inner gasket 366 may be made of the same material as the lancet port body 362. The inner gasket 366 may completely block the orifice 364 until penetrated by a lancet inserted into the lancet port 360. The inner gasket 366 may be formed by, for example, molding the lancet port body 362 to include the inner gasket 366. Optionally, where the inner gasket 366 is integrally formed with the lancet port body 362, the inner gasket 366 may further serve as a piercing barrier membrane, and a separate piercing barrier membrane, such as the piercing barrier membranes 314, 332, or 354 described above and shown in Figures 3A to 3C may be optionally included or omitted.

[0051] Figure 4Shows an exploded view of a bag according to an embodiment. The bag 400 includes a fitting 402, the fitting including a lancet port 404. The fitting 402 can be any fitting as described herein. The fitting 402 further includes a first sidewall 422 and a second sidewall 424. The fitting 402 can include a fluoropolymer material or consist entirely of a fluoropolymer material. The bag 400 further includes a first sheet 406 having a first perimeter 408. The first sheet perimeter 408 includes a first portion 410 and a second portion 412. The bag 400 also includes a second sheet 414 having a second sheet perimeter 416. The second perimeter 416 includes a first portion 418 and a second portion 420. The first sheet perimeter 408 and the second sheet perimeter 416 are outer regions of the respective first sheet 406 and second sheet 412. One or both of the first sheet 406 and the second sheet 414 can include a fluoropolymer material or consist entirely of a fluoropolymer material. The fluoropolymer material used for the first sheet 406 and the second sheet 414 can be the same as the fluoropolymer material used in the fitting 402. The bag 400 can be formed by joining the first sheet perimeter 408 to the second sheet perimeter 416 at the respective first portions 410, 418. Forming the bag 400 further includes joining the second portion 412 of the first sheet perimeter 408 to the first sidewall 422 of the fitting 402, and joining the second portion 420 of the second perimeter 416 to the second sidewall 424 of the fitting 402. The entire first sheet perimeter 408 and the entire second sheet perimeter 416 are joined to another sheet perimeter 408, 416 or the fitting 402 to separate the interior of the bag from the external environment. The joining of the first sheet perimeter 408 and the second sheet perimeter 416 and / or the fitting 402 can be by any suitable means of joining materials, such as welding, for example, heat welding. In an embodiment, the welding can have a weld width in the range from about 1 / 8 inch (about 3.2 millimeters (mm)) to about 1 / 2 inch (about 12.7 mm). Using a larger weld width can provide robustness to the welding during cooling and heating of the bag. The joining of the perimeters 408, 416 can be located at a position spaced from the edges of the first sheet 406 and the second sheet 414, but still within their outer regions, which is suitable for forming the bag. In an embodiment, the welding joining the first sheet 406 and the second sheet 414 can have the same weld width as the welding joining the first sheet 406 to the fitting 402 and / or the welding joining the second sheet 414 to the fitting 402. In an embodiment, the welding joining the first sheet 406 and the second sheet 414 can have a different weld thickness from the welding joining the first sheet 406 to the fitting 402 and / or the welding joining the second sheet 414 to the fitting 402.

[0052] Figure 5Disclosed is a method of manufacturing a bag according to an embodiment. Method 500 includes providing a fitting body 502, installing an inner gasket into the fitting body 504, and attaching a puncture barrier layer 506. Method 500 may further include providing a first sheet and a second sheet 508, joining the first sheet to the second sheet 510, and joining the first sheet and the second sheet to the fitting 512.

[0053] Provide a fitting body at 502. The fitting body includes a lancet port. In an embodiment, the lancet port may be attached to the fitting body by welding. In an embodiment, the lancet port may be integrally formed with the fitting body. The fitting body may be any fitting body that includes a lancet port as described herein, such as Figure 1 the fitting 100 shown and described above, Figure 2 the fitting 200 shown and described above, including Figures 3A to 3C a fitting with one of the lancet ports 300, 320, 340 shown and described above, and so on. The fitting body provided at 502 may be formed of a fluoropolymer material.

[0054] At 504, install an inner gasket into the fitting body. The inner gasket may be configured such that the inner gasket can be installed into the fitting body, for example, by having its outer diameter equal to or less than the inner diameter of at least a portion of the lancet port included in the fitting body. In an embodiment, installing the inner gasket at 504 includes inserting the inner gasket into the lancet port. The inner gasket may be inserted into a position where it forms a press fit against the inner surface of the lancet port. The inner gasket may be inserted to a depth where it contacts a shoulder formed where the inner diameter of the lancet port changes from a first inner diameter to a second inner diameter. The inner gasket may be inserted such that corresponding engagement features provided on the inner gasket and on the inner surface of the lancet port can engage with each other, for example, to hold the inner gasket and / or prevent the inner gasket from rotating relative to the lancet port.

[0055] At 506, attach a puncture barrier layer. For example, the puncture barrier layer may be a fluoropolymer film. The puncture barrier layer may be attached at 506 such that it closes an orifice provided in the lancet port. The puncture barrier layer may be attached at one end of the lancet port, within the orifice, or in any other suitable location where the puncture barrier layer can close the orifice of the lancet port through the fitting. In an embodiment, the puncture barrier layer is attached at the end of the lancet port. The puncture barrier layer may be attached by any suitable attachment means to form a seal. In an embodiment, the puncture barrier layer is attached by welding, such as heat welding and ultrasonic welding or any other suitable welding. In an embodiment, the puncture barrier layer is attached by heat welding.

[0056] A first sheet and a second sheet 508 can be provided to form a bag containing a fitting, the fitting having a lancet port, an internal gasket, and a puncture barrier layer. The first sheet and the second sheet can be sheets of any suitable material, such as a film of a fluoropolymer material. In an embodiment, the first sheet and the second sheet can comprise a fluoropolymer material that is also included in the fitting body. In an embodiment, the first sheet and the second sheet comprise ethylene tetrafluoroethylene (ETFE). The first sheet and the second sheet can be sized and shaped appropriately to form the bag.

[0057] The first sheet and the second sheet can be joined to each other at 510. The first sheet and the second sheet are joined above a portion of their perimeters, at or near their outermost edges. For example, the sheets can be joined by welding (such as heat welding). The welding can be continuous above a portion of the perimeters of the first sheet and the second sheet. In an embodiment, the welding can have a weld width in the range from about 1 / 8 inch (about 3.2 millimeters (mm)) to about 1 / 2 inch (about 12.7 mm).

[0058] The first sheet and the second sheet can be joined to the fitting at 512. A portion of the perimeter of the first sheet that is not or will not be joined to the second sheet is attached to a first sidewall of the fitting. A portion of the perimeter of the second sheet that is not or will not be joined to the first sheet is attached to a second sidewall of the fitting. The attachment of the first sheet and the second sheet to the fitting can be by any suitable method of joining the sheets to the fitting. In an embodiment, at 512, the first sheet and the second sheet are joined to the fitting by welding (such as heat welding). In an embodiment, the welding can have a weld width in the range from about 1 / 8 inch (about 3.2 millimeters (mm)) to about 1 / 2 inch (about 12.7 mm). The attachment of the first sheet and the second sheet to the fitting can be by a continuous attachment that satisfies the joining of the first sheet and the second sheet to each other. The continuous attachment can reduce or eliminate weaknesses in the attachment of the sheets to the fitting to each other. Although method 500 is shown in Figure 5 as joining the first sheet and the second sheet to each other at 510 before joining the first sheet and the second sheet to the fitting at 512, it should be understood that the order of these steps can vary. In an embodiment, the first sheet and / or the second sheet can be joined to the fitting at 512 before joining the first sheet and the second sheet to each other at 510. In an embodiment, the first sheet and the second sheet can be joined to each other at 510 during a time period that overlaps with the time of joining the first sheet and the second sheet to the fitting at 512. When the sheets are attached to each other at 510 and to the fitting at 512, only the fitting can allow communication with the interior space of the resulting bag, for example, through the lancet port.

[0059] Figure 6Disclosed is a method of using a bag according to an embodiment. Method 600 includes providing a bag 602, filling the bag with a process fluid 604, subjecting the bag and the process fluid to a cryogenic temperature 606, and inserting a stylet into a stylet port 608. The bag provided at 602 can be any of the bags provided herein, including a fitting having a stylet port. At 604, the bag can be filled with a process fluid. The process fluid can be any suitable process fluid, such as a bioreaction mixture, such as any other suitable contents including cells, cell culture medium, gene therapy materials, and / or the process fluid. At 606, the bag and the process fluid can be exposed to or subjected to a cryogenic temperature, such as subjecting the bag and the process fluid to the temperature of dry ice, liquid nitrogen, and the like. In an embodiment, the bag can be subjected to a cryogenic temperature in a freezing system (such as, a blast chiller, a cryogenic freezer, etc.). In an embodiment, the bag is exposed to a temperature of -50 °C or lower. In an embodiment, the bag is exposed to a temperature of -80 °C or lower. In an embodiment, the bag is exposed to a temperature of -150 °C or lower. In an embodiment, the bag is exposed to a temperature of -190 °C or lower. After the cryogenic exposure at 606, the stylet can be inserted into the bag 608. The stylet is inserted through the stylet port included in the fitting of the bag provided at 602. In an embodiment, after the cryogenic exposure at 606 and before the stylet insertion at 608, the bag and the process fluid can be thawed. The insertion of the stylet can be used when withdrawing the process fluid from the bag, such as transferring the process fluid to another container, administering the process fluid to a subject, or performing any other suitable process fluid withdrawal from the bag.

[0060] Aspect:

[0061] It should be understood that any one of aspects 1 to 10 and 21 can be combined with any one of aspects 11 to 19 or aspect 20. It should be understood that any one of aspects 11 to 19 can be combined with aspect 20.

[0062] Aspect 1. A fitting for a bag, comprising:

[0063] A fitting body including a first side wall and a second side wall, each of the first side wall and the second side wall extending between opposite end points, the fitting body comprising a fluoropolymer material; and

[0064] A stylet port, comprising:

[0065] A stylet port body integrally formed with the fitting body, the stylet port body including an orifice configured to receive a stylet;

[0066] A first puncture barrier layer including a fluoropolymer film; and

[0067] An inner washer, which is disposed within the lancet port body, the inner washer being configured to provide a second puncture barrier layer.

[0068] Aspect 2. The fitting according to aspect 1, wherein the inner washer comprises silicone, thermoplastic elastomer, fluoropolymer, ethylene vinyl acetate, or a combination thereof.

[0069] Aspect 3. The fitting according to any one of aspects 1 to 2, wherein the diameter of the orifice ranges from 0.18 inches (about 4.5 mm) to 0.22 inches (about 5.6 mm).

[0070] Aspect 4. The fitting according to any one of aspects 1 to 3, further comprising an additional port integrally formed with the fitting body.

[0071] Aspect 5. The fitting according to any one of aspects 1 to 4, wherein the first puncture barrier layer is joined to one end of the lancet port body by welding, the first puncture barrier layer covering the orifice.

[0072] Aspect 6. The fitting according to any one of aspects 1 to 5, wherein the first puncture barrier layer is disposed within the orifice.

[0073] Aspect 7. The fitting according to any one of aspects 1 to 6, wherein the inner surface of the lancet port body includes an annular protrusion and the outer surface of the inner washer includes an annular groove.

[0074] Aspect 8. The fitting according to any one of aspects 1 to 7, wherein the orifice has a first diameter in a first portion of the lancet port body and a second diameter less than the first diameter in a second portion of the lancet port body, and the inner washer has an outer diameter less than the first diameter and greater than the second diameter.

[0075] Aspect 9. The fitting according to aspect 8, wherein the inner surface of the lancet port body includes one or more first engagement features and the inner washer includes one or more second engagement features, the one or more second engagement features being configured to engage with the first engagement features.

[0076] Aspect 10. A bag, comprising the fitting according to any one of aspects 1 to 9, a first fluoropolymer sheet, and a second fluoropolymer sheet,

[0077] wherein a first portion of the perimeter of the first fluoropolymer sheet is welded to a first portion of the perimeter of the second fluoropolymer sheet,

[0078] the second portion of the perimeter of the first fluoropolymer sheet is welded to the fitting,

[0079] The second part of the perimeter of the second fluoropolymer sheet is welded to the fitting.

[0080] The first part of the perimeter of the first fluoropolymer sheet and the second part of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet, and

[0081] The first part of the perimeter of the second fluoropolymer sheet and the second part of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet.

[0082] Aspect 11. A method, comprising:

[0083] Providing a fitting, the fitting including a fitting body, the fitting body including a first sidewall and a second sidewall, each of the first sidewall and the second sidewall extending between opposite end points, the first sidewall and the second sidewall defining a central opening, the fitting body including a fluoropolymer material and a cannula port body integrally formed with the fitting body, the cannula port body including an orifice configured to receive a cannula, the fitting including a fluoropolymer;

[0084] Installing an internal washer into the cannula port body; and

[0085] Welding a fluoropolymer film to the fitting to provide a puncture barrier layer.

[0086] Aspect 12. The method according to aspect 11, further comprising:

[0087] Providing a first fluoropolymer sheet;

[0088] Providing a second fluoropolymer sheet;

[0089] Welding a first part of the perimeter of the first fluoropolymer sheet to a first part of the perimeter of the second fluoropolymer sheet; and

[0090] Welding a second part of the perimeter of the first fluoropolymer sheet and a second part of the second fluoropolymer sheet to the fitting,

[0091] wherein the first part of the perimeter of the first fluoropolymer sheet and the second part of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet, and

[0092] The first portion of the perimeter of the second fluoropolymer sheet and the second portion of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet.

[0093] Aspect 13. The method according to any one of aspects 11 to 12, wherein the inner gasket comprises silicone, thermoplastic elastomer, fluoropolymer, ethylene vinyl acetate, or a combination thereof.

[0094] Aspect 14. The method according to any one of aspects 11 to 13, wherein the diameter of the orifice ranges from 0.18 inches (about 4.5 mm) to 0.22 inches (about 5.6 mm).

[0095] Aspect 15. The method according to any one of aspects 11 to 14, wherein the fluoropolymer film is joined to one end of the lancet port body and covers the orifice.

[0096] Aspect 16. The method according to any one of aspects 11 to 15, wherein the fluoropolymer film is disposed within the lancet port body.

[0097] Aspect 17. The method according to any one of aspects 11 to 16, wherein an inner surface of the lancet port body includes an annular protrusion and an outer surface of the inner gasket includes an annular groove, and installing the inner gasket includes positioning the inner gasket such that the annular protrusion is received within the annular groove.

[0098] Aspect 18. The method according to any one of aspects 11 to 17, wherein the orifice has a first diameter in a first portion of the lancet port body and a second diameter less than the first diameter in a second portion of the lancet port body, and the inner gasket has an outer diameter less than the first diameter and greater than the second diameter, and installing the inner gasket includes inserting the inner gasket from the first portion of the lancet port body into the orifice.

[0099] Aspect 19. The method according to aspect 18, wherein the inner surface of the lancet port body includes one or more first engagement features and the inner gasket includes one or more second engagement features, the one or more second engagement features being configured to engage with the first engagement features, and installing the inner gasket includes engaging the one or more first engagement features with the one or more second engagement features.

[0100] Aspect 20. A method of implementing a process, comprising:

[0101] Providing a bag according to aspect 10;

[0102] Add a process fluid to the bag;

[0103] Bring the bag to a temperature of -80 °C or lower; and

[0104] Insert a stylet into the orifice of the stylet port.

[0105] Aspect 21. The fitting according to any one of aspects 1 to 9, wherein the stylet port is independent of the configuration of the stylet.

[0106] The examples disclosed in this application are to be considered illustrative rather than restrictive in all respects. The scope of the invention is indicated by the appended claims rather than the foregoing description; and all changes that come within the meaning and range of the equivalent form of the claims are intended to be embraced within the claims.

Claims

1. An accessory for a bag, comprising: An accessory body including a first sidewall and a second sidewall, each of the first sidewall and the second sidewall extending between opposite end points, the accessory body comprising a fluoropolymer material; And A lancet port, comprising: A lancet port body integrally formed with the accessory body, the lancet port body comprising an orifice configured to receive a lancet; A first puncture barrier layer including a fluoropolymer film; and An inner gasket disposed within the lancet port body, the inner gasket configured to provide a second puncture barrier layer.

2. The accessory according to claim 1, wherein the inner gasket comprises silicone, a thermoplastic elastomer, a fluoropolymer, ethylene vinyl acetate, or a combination thereof.

3. The accessory according to claim 1, wherein the diameter of the orifice ranges from 0.18 inches to 0.22 inches.

4. The accessory according to claim 1, further comprising an additional port integrally formed with the accessory body.

5. The accessory according to claim 1, wherein the first puncture barrier layer is joined to one end of the lancet port body by welding, and the first puncture barrier layer covers the orifice.

6. The accessory according to claim 1, wherein the first puncture barrier layer is disposed within the orifice.

7. The accessory according to claim 1, wherein an inner surface of the lancet port body comprises an annular protrusion and an outer surface of the inner gasket comprises an annular groove.

8. The accessory according to claim 1, wherein the orifice has a first diameter in a first portion of the lancet port body and a second diameter less than the first diameter in a second portion of the lancet port body, and the inner gasket has an outer diameter less than the first diameter and greater than the second diameter.

9. The accessory according to claim 8, wherein the inner surface of the lancet port body comprises one or more first engagement features and the inner gasket comprises one or more second engagement features configured to engage with the first engagement features.

10. A bag, comprising the accessory according to claim 1, a first fluoropolymer sheet, and a second fluoropolymer sheet, wherein a first portion of a perimeter of the first fluoropolymer sheet is welded to a first portion of a perimeter of the second fluoropolymer sheet, the second portion of the perimeter of the first fluoropolymer sheet is welded to the accessory, the second portion of the perimeter of the second fluoropolymer sheet is welded to the accessory, the first portion and the second portion of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet, and the first portion and the second portion of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet.

11. A method, comprising: Provide a fitting, the fitting including a fitting body, the fitting body including a first sidewall and a second sidewall, each of the first sidewall and the second sidewall extending between opposite endpoints, the first sidewall and the second sidewall defining a central opening, the fitting body including a fluoropolymer material and a lancet port body integrally formed with the fitting body, the lancet port body including an orifice configured to receive a lancet, the fitting including a fluoropolymer; Install an internal washer into the lancet port body; and Weld a fluoropolymer film to the fitting to provide a puncture barrier layer.

12. The method according to claim 11, further comprising: Provide a first fluoropolymer sheet; Provide a second fluoropolymer sheet; Weld a first portion of the perimeter of the first fluoropolymer sheet to a first portion of the perimeter of the second fluoropolymer sheet; and Weld a second portion of the perimeter of the first fluoropolymer sheet and a second portion of the second fluoropolymer sheet to the fitting, wherein the first portion of the perimeter of the first fluoropolymer sheet and the second portion of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet, and the first portion of the perimeter of the second fluoropolymer sheet and the second portion of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet.

13. The method according to claim 11, wherein the internal washer includes silicone, thermoplastic elastomer, fluoropolymer, ethylene vinyl acetate, or a combination thereof.

14. The method according to claim 11, wherein the diameter of the orifice is in the range from 0.18 inches to 0.22 inches.

15. The method according to claim 11, wherein the fluoropolymer film is joined to one end of the lancet port body and covers the orifice.

16. The method according to claim 11, wherein the fluoropolymer film is disposed within the lancet port body.

17. The method according to claim 11, wherein an inner surface of the lancet port body includes an annular protrusion and an outer surface of the internal washer includes an annular groove, and installing the internal washer includes positioning the internal washer such that the annular protrusion is received within the annular groove.

18. The method according to claim 11, wherein the orifice has a first diameter in a first portion of the lancet port body and a second diameter less than the first diameter in a second portion of the lancet port body, and the internal washer has an outer diameter less than the first diameter and greater than the second diameter, and installing the internal washer includes inserting the internal washer from the first portion of the lancet port body into the orifice.

19. The method according to claim 18, wherein an inner surface of the lancet port body includes one or more first engagement features and the inner gasket includes one or more second engagement features, the one or more second engagement features being configured to engage with the first engagement features, and installing the inner gasket includes engaging the one or more first engagement features with the one or more second engagement features.

20. A method of implementing a process, comprising: providing a bag according to claim 10; adding a process fluid to the bag; bringing the bag to a temperature of -80 °C or lower; and inserting the lancet into the orifice of the lancet port.

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