Infusion site with membrane and leakproof removable protection

Abstract

To provide a medical device for transferring fluid from a flexible container for medicine.SOLUTION: The medical device comprises an upper portion 1101, a central portion 1104, a breakable zone 1103 between the upper portion and the central portion, and an insertion portion 1106. The insert comprises a third enclosure 1105 surrounding the second tunnel 1110, the upper side of the third enclosure comprising a membrane 1116, the upper surface of the membrane sealing the third opening 1113 of the second enclosure 1115.SELECTED DRAWING: Figure 1a

Description

[Technical Field]

[0001]

[0001] The present disclosure relates to medical devices for transferring liquids or fluids, and more particularly to injection sites (e.g., addition sites or addition-use sites) used on flexible pharmaceutical containers to add or remove liquids or fluids. More specifically, the injection site includes both a tamper-evident, breakable protective cover to protect the exterior surface of a septum from contamination prior to use, and a membrane to prevent direct contact between the septum and the liquid or fluid. [Background technology]

[0002]

[0002] Infusion sites are used to add micronutrients or medications to flexible medical bags containing liquids by needle puncture through a self-sealing septum component prior to administration of the mixed solution. Sometimes, withdrawal of liquid from flexible medical bags is also performed in the same manner via the infusion site.

[0003]

[0003] In many cases, the outer surface of a self-sealing septum is unprotected and therefore requires disinfection of its surface with alcohol or another disinfectant before proceeding with needle insertion. However, if the product is placed in secondary packaging before sterilization, the risk of having microbiological contamination on the outer septum surface is limited. However, this risk is significantly higher if the product is sterilized before adding the secondary packaging. In that case, it is recommended to use an injection site with a protective cover.

[0004] Another feature of some injection sites is the inclusion of a membrane to prevent direct contact between the self-sealing septum and the solution (i.e., liquid or fluid). Such a membrane can also increase gas permeability, reduce water loss from the liquid or fluid, and protect the solution (i.e., liquid or fluid) from oxygen transfer. Finally, the membrane also reduces the risk of leaching substances through the septum, which is typically made from polyisoprene rubber.

[0005] However, existing products do not include both a removable protective cover and membrane. Therefore, what is needed in the art is an injection site that includes a sealing membrane that prevents contact between the septum and a solution (i.e., a liquid or fluid) and a leak-proof, tamper-evident, removable protection for protecting the exterior surface of the septum from outside contamination. Summary of the Invention

[0006] The present invention provides an injection site (also referred to as an addition site or addition-use site) for use with a flexible pharmaceutical container to effect the addition or removal of a fluid or liquid from the flexible pharmaceutical container. Related embodiments described herein relate to an injection site that includes both a tamper-evident, breakable protective cover for protecting the exterior surface of a septum from contamination prior to use, and a membrane that prevents direct contact between the septum and a solution (e.g., a fluid or liquid).

[0007] According to one aspect, the present disclosure relates to a medical device for transferring fluids from a flexible medical container, the medical device comprising: an upper portion including a first wall surrounding a solid or hollow portion; a central portion including a second opening connected to the first opening and having a second inner diameter, a second wall surrounding a first housing having a third inner diameter for holding a septum, and a third opening having the third inner diameter; a breakable area between the upper portion and the central portion; and an insert including a third wall surrounding a second tunnel, an upper side of the third wall including a membrane, the upper surface of the membrane sealing the third opening in the second wall.

[0008]

[0008] In one embodiment, the upper portion comprises a first enclosure wall surrounding a first tunnel having a first inner diameter, and a first opening having an inner diameter that gradually expands from a first inner diameter at a first end of the first opening to a second inner diameter at a second end of the first opening.

[0009]

[0009] In one embodiment, the upper portion includes a first surrounding wall surrounding the solid body and a first opening having a first inner diameter, the first inner diameter being the same as the second inner diameter.

[0010] In one embodiment, the first enclosure wall, the second enclosure wall and the frangible area are all made of the same material.

[0011]

[0011] In one embodiment, the first enclosure wall, the second enclosure wall and the breakable area are all made from a blend of polyethylene (PE), polypropylene (PP), ethylene and propylene copolymer, polyolefin elastomer and / or ethylene-vinyl acetate (EVA) mixture.

[0012] In one embodiment, the first enclosure wall, the second enclosure wall and the breakable zone are all made from a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

[0013] In one embodiment, the septum is a self-sealing septum.

[0014]

[0014] In one embodiment, the septum is made of an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymer, polyurethane, vinyl, and mixtures thereof.

[0015] In one embodiment, the septum is made of polyisoprene.

[0016] In one embodiment, the second surrounding wall of the central portion has a convex structure near the third opening, and the convex structure fits into the concave structure on the upper surface of the insert portion.

[0017] In one embodiment, the third inner diameter is greater than the second inner diameter.

[0018] In one embodiment, the breakable area is made of a material that is rigid enough to allow easy breaking of the breakable tamper-evident cap and ductile enough to prevent particle formation after breaking.

[0019] In one embodiment, the top section, middle section and insert section are molded into a single device.

[0020] In one embodiment, the top, middle and insert sections are molded separately and assembled into a single device.

[0021] In one embodiment, the upper portion includes fins attached to an outer surface of the first enclosure.

[0022] In one embodiment, the insert comprises a flange attached to an outer surface of the third enclosure.

[0023] According to another aspect, the present disclosure relates to an injection site comprising: an upper portion including a first wall surrounding a first tunnel and a first opening at a bottom of the first wall; a central portion located inside the first tunnel near the bottom of the first wall and including a second wall surrounding a first housing for holding a septum and a membrane at the bottom of the second wall; an insert portion including a third wall surrounding a second tunnel and a second opening at a top of the second tunnel, the bottom surface of the membrane sealing the second opening in the third wall; and a breakable region between the upper portion and the insert portion.

[0024] In one embodiment, the first enclosure wall, the second enclosure wall and the frangible zone are all made of the same material.

[0025]

[0025] In one embodiment, the first enclosure wall, the second enclosure wall and the breakable area are all made from a blend of polyethylene (PE), polypropylene (PP), ethylene and propylene copolymers, polyolefin elastomers and / or ethylene-vinyl acetate (EVA) mixtures.

[0026] In one embodiment, the first enclosure wall, the second enclosure wall and the breakable zone are all made from a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

[0027] In one embodiment, the septum is a self-sealing septum.

[0028]

[0028] In one embodiment, the septum is made of an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymer, polyurethane, vinyl, and mixtures thereof.

[0029] In one embodiment, the septum is made of polyisoprene.

[0030]

[0030] In one embodiment, the breakable area is made of a material that is rigid enough to allow easy breaking of the breakable tamper-evident cap and ductile enough to prevent particle formation after breaking.

[0031] In one embodiment, the top, middle and insert sections are molded into a single injection site.

[0032] In one embodiment, the top, middle and insert sections are molded separately and assembled into a single injection site.

[0033] In one embodiment, the upper portion comprises fins attached to an outer surface of the first enclosure.

[0034] In one embodiment, the insert comprises fins attached to an outer surface of the third enclosure.

[0035] According to another aspect, the present disclosure relates to a medical device for transferring fluids from a medical flexible container, the medical device including: a top portion including a first enclosure wall surrounding a first housing for holding a septum, the first housing having a first opening at a top of the first housing, and a membrane at a bottom of the first enclosure wall; a lid sealing the first opening of the first housing; and an insert portion including a second enclosure wall surrounding a first tunnel and a second opening at the top of the first tunnel, the bottom surface of the membrane sealing the second opening of the insert.

[0036] In one embodiment, the septum is a self-sealing septum.

[0037]

[0036] In one embodiment, the septum is made of an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymer, polyurethane, vinyl, and mixtures thereof.

[0038] In one embodiment, the septum is made of polyisoprene.

[0039] In one embodiment, the top, lid and insert are molded into a single medical device.

[0040] In one embodiment, the top, lid and insert are molded separately and assembled into a single medical device.

[0041] In one embodiment, the insert comprises fins attached to an outer surface of the second enclosure.

[0042] In one embodiment, instead of introducing a breakable section to remove the top of the device before use, a "flip-top" cap can be used.

[0043] According to another aspect, the present disclosure relates to a method for transferring fluid from a flexible medical container by using the above-mentioned medical device, the method including the steps of connecting the medical device with the flexible medical container, breaking a top of the medical device, piercing the septum with a syringe needle, and transferring the fluid from the flexible medical container. [Brief explanation of the drawings]

[0044] [Figure 1a] 1 is a schematic diagram showing a cross section of a design of an injection site 1100 according to a specific embodiment of the present invention, comprising an upper portion 1101, a central portion 1104 holding a septum 1112, a breakable area 1103 between the upper portion 1101 and the central portion 1104, and an insert portion 1106. [Figure 1b] 1A is a schematic diagram showing a cross section of a portion of a design of an injection site 1200 according to FIG. 1A of the present invention, comprising an upper portion 1201, a middle portion 1204, and a breakable area 1203 between the upper portion 1201 and the middle portion 1204. FIG. [Figure 1c] 13 is a schematic diagram showing a cross section of a portion of an injection site design according to FIG. 1a of the present invention, with a septum 1300. FIG. [Figure 1d] 1B is a schematic diagram showing a cross section of a portion of an injection site design according to FIG. 1A of the present invention with an insert 1400. FIG. [Figure 1e] 1 a is a schematic diagram showing a cross section of an injection site 1500 design according to a specific embodiment of the invention, comprising an upper portion 1501, a central portion 1504 that holds a septum 1512, a breakable area 1503 between the upper portion 1501 and the central portion 1504, and an insert portion 1506. Unlike the injection site 1100 of FIG. 1 a, the upper portion 1501 of the injection site 1500 comprises an enclosure wall 1502 that surrounds a solid body. [Figure 2a] Schematic diagram showing the design of an injection site 2100 according to a specific embodiment of the present invention, comprising an upper portion 2101 with fins 2102, a central portion 2104 that holds a septum (not shown), a breakable area 2103 between the upper portion 2101 and the central portion 2104, and an insert portion 2105 with a flange 2106. [Figure 2b]2a is a schematic diagram showing a portion of the design of an injection site 2200 according to FIG. 2a of the present invention, comprising an upper portion 2201 with fins 2202, a central portion 2204 that holds a septum (not shown), and a breakable area 2203 between the upper portion 2201 and the central portion 2204. [Figure 2c] FIG. 2 is a schematic diagram showing a portion of the design of an injection site 2300 according to a specific embodiment of the present invention, comprising an upper portion 2301, a central portion 2302 for holding a septum (not shown), and a breakable area 2303 between the upper portion 2301 and the central portion 2303. [Figure 2d] 2 is a schematic diagram showing a cross section of a portion of a design of an injection site 2400 according to a specific embodiment of the present invention, comprising an upper portion 2401, a central portion 2402 that holds a septum (not shown), and a breakable area 2403 between the upper portion 2401 and the central portion 2402. [Figure 2e] FIG. 2 is a schematic diagram showing a cross section of a portion of a design of an injection site 2500 according to a specific embodiment of the present invention, comprising an upper portion 2501, a central portion 2502 for holding a septum (not shown), and a breakable area 2503 between the upper portion 2501 and the central portion 2502. [Figure 3a] Schematic diagram showing a cross section of a portion of the design of an injection site 3100 according to a particular embodiment of the present invention, comprising an upper portion 3101 with fins 3102, a central portion 3104 that holds a septum (not shown), an insert portion 3105, and a breakable area 3103 between the upper portion 3101 and the insert portion 3105. [Figure 3b] FIG. 3 is a schematic diagram showing a cross section of another design of injection site 3200 according to certain embodiments of the present invention, comprising a top portion 3201 that holds a septum 3203, a lid 3202 that covers the septum 3203, and an insert portion 3208 that includes a wide, flat base 3204 that seals directly to the film. [Figure 3c] FIG. 3 is a schematic diagram showing the design of an injection site 3300 according to a specific embodiment of the present invention, comprising a top portion 3301 that holds a septum (not shown), a lid 3302 that covers the septum, and an insert portion 3303 that includes a wide, flat base 3204 that seals directly to the film. [Figure 4a]FIG. 4 is a schematic diagram showing a cross section of another design of injection site 4100 according to certain embodiments of the present invention, comprising cap 4101, central portion 4104 that holds a septum, and insert portion 4106. [Figure 4b] FIG. 42 is a schematic diagram illustrating another design of an injection site 4200 according to certain embodiments of the present invention, comprising a cap 4201, a central portion 4204 that holds a septum, and an insert portion 4206. [Figure 4c] FIG. 43 is a schematic diagram illustrating another design of an injection site 4300 according to certain embodiments of the present invention, comprising a cap 4301, a central portion 4304 that holds a septum, and an insert portion 4306. [Figure 4d] FIG. 44 is a schematic diagram illustrating another design of an injection site 4400 according to certain embodiments of the present invention, comprising a cap 4401, a central portion 4404 that holds a septum, and an insert portion 4406. [Figure 4e] FIG. 45 is a schematic diagram illustrating another design of an injection site 4500 according to certain embodiments of the present invention, comprising a cap 4501, a central portion 4504 that holds a septum, and an insert portion 4506. [Figure 4f] FIG. 46 is a schematic diagram illustrating another design of an injection site 4600 according to certain embodiments of the present invention, comprising a cap 4601, a central portion 4604 that holds a septum, and an insert portion 4606. [Figure 4g] FIG. 4 is a schematic diagram showing a cross section of another design of injection site 4700 according to certain embodiments of the present invention, comprising cap 4701, central portion 4704 holding septum 4705, and insert portion 4706. [Figure 4h] FIG. 48 is a schematic diagram illustrating another design of an injection site 4800 according to certain embodiments of the present invention, comprising a cap 4801, a central portion 4804 that holds a septum, and an insert portion 4806. DETAILED DESCRIPTION OF THE INVENTION

[0045]

[0064] The present invention relates generally to the fields of medical devices and parenteral nutrition. More particularly, the present invention relates to an infusion site (also referred to as an addition site or dosing site) that is used with a flexible pharmaceutical container to allow the addition or removal of a fluid or liquid from the flexible pharmaceutical container. Related embodiments described herein relate to an infusion site that includes both a tamper-evident, breakable protective cover for protecting the exterior surface of a septum from contamination prior to use, and a membrane that prevents direct contact between the septum and a solution (e.g., a fluid or liquid).

[0046]

[0065] In one embodiment, the flexible pharmaceutical container is either a monobag, such as any flexible pharmaceutical bag, or a multi-chamber bag (MCB), such as any multi-chamber flexible pharmaceutical bag. In one embodiment, the flexible pharmaceutical container is a multi-chamber bag (MCB), such as any multi-chamber flexible pharmaceutical bag. The medical device or infusion site of the present invention can be used to add or remove fluids from a multi-chamber bag (MCB) or a multi-chamber flexible pharmaceutical bag.

[0047]

[0066] In one embodiment, the medical device / infusion site may be used to transfer nutrients, macronutrients or micronutrients, fluids such as home parenteral nutrition, or total parenteral nutrition (TPN).

[0048]

[0067] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. As used herein, the following terms have the following meanings:

[0049]

[0068] As used herein, the words "comprising" or "comprises" are intended to mean that the compositions and methods include the recited elements, but do not exclude other elements.

[0050]

[0069] The term "about," when used before numerical designations, including ranges, for example of temperature, time, amount, and concentration, indicates approximations that may vary (+) or (-) 10%, 5%, or 1%.

[0051]

[0070] As used herein, the expression "injection site" refers to a medical device that can add or remove micronutrients or medications to or from a flexible medical bag by needle puncture through a self-sealing septum component prior to administration of the mixed solution.

[0052]

[0071] As used herein, the phrase "breakable zone" refers to a region of a medical device that can be broken at a desired time. For example, a breakable zone of a medical device may have thinner walls than the walls of other regions.

[0053]

[0072] As used herein, the term "nutrients" refers to substances that living organisms, including humans, use to survive, grow, and reproduce. Some nutrients can be metabolically converted into smaller molecules, such as carbohydrates and lipids, in a process that releases energy. All living organisms require water. Essential nutrients for animals and humans are energy sources, some amino acids that combine to produce proteins, some fatty acids, vitamins, and certain minerals and trace elements.

[0054]

[0073] A classification primarily used to describe the nutritional needs of humans and animals divides nutrients into "macronutrients" and "micronutrients." Macronutrients, consumed in relatively large amounts, are used primarily to generate energy or for incorporation into tissues for growth and repair. Specifically, the term "macronutrient" refers to nutrients that include carbohydrates, amino acids, and lipids.

[0055]

[0074] "Micronutrients" are essential elements that humans require in small amounts throughout life for various physiological functions to maintain health. In the context of the present invention, the term "micronutrients" refers to vitamins and trace elements. In the context of the present invention, trace elements can be provided, for example, as chloride or sodium salts, gluconates or sulfates.

[0056]

[0075] As used herein, the term "home parenteral nutrition" refers to nutritional support for patients whose nutritional needs cannot be met through oral or enteral intake and who can receive treatment outside of a hospital setting. HPN is a major life-saving therapy for patients with chronic intestinal failure (CIF), for example. HPN can also be provided as palliative nutrition for patients in the later stages of terminal illnesses, including cancer (Pironi et al.: ESPEN guideline on home parenteral nutrition. Clinical Nutrition (2020), 39:1645-1666).

[0057]

[0076] The expression "total parenteral nutrition (TPN)" refers to parenteral nutrition, which provides all daily nutritional needs intravenously to patients who are otherwise unable to ingest and / or digest nutrients. TPN can be short-term or long-term nutrition therapy. "Partial parenteral nutrition (PPN)" refers to parenteral nutrition for patients whose nutritional needs cannot be fully met by enteral or oral routes. TPN and PPN can be provided to hospitalized patients, including those in intensive care, as well as to home parenteral patients, to avoid malnutrition.

[0058]

[0077] As used herein, the expression "multi-chamber bag (MCB)," which is used interchangeably herein with the expression "multi-chamber container," refers to a container or bag made from a flexible film material and compartmentalized into two or more chambers. They allow for the safe and stable containment of pharmaceutical solutions that must be kept separate until the formulations can be mixed (reconstituted) immediately prior to administration to a patient to avoid inevitable reactions between the formulations. Thus, MCBs have peelable seals or welds (e.g., removable heat welds) between the chambers to be reconstituted. The welds or seals can be opened, for example, by squeezing.

[0059]

[0078] As used herein, the term "polymer" refers to a compound prepared by polymerizing the same or different types of monomers, which, in polymerized form, provide the multiple and / or repeating "units" that make up the polymer. Thus, the generic term "polymer" encompasses the term "homopolymer," which is commonly used to refer to a polymer prepared from only one type of monomer, and the term "copolymer," which is commonly used to refer to a polymer prepared from at least two types of monomer. It also encompasses all forms of copolymers, e.g., random, block, etc. The terms "ethylene / α-olefin polymer" and "propylene / α-olefin polymer" refer to the above copolymers prepared from polymerizing ethylene or propylene, respectively, with one or more additional polymerizable α-olefin monomers. While polymers are often referred to as "made from" one or more specified monomers, "based on" specified monomers or types of monomers, "containing" specified monomer contents, etc., it should be noted that in this context, the term "monomer" refers to the polymerized residue of the specified monomer, not the unpolymerized species. Trace impurities, such as catalyst residues, may be present incorporated into the polymer.

[0060]

[0079] As used herein, the term "copolymer" refers to a polymer prepared by polymerizing at least two different types of monomers. Thus, the generic term copolymer includes polymers made from two different types of monomers, as well as polymers made from three or more different types of monomers.

[0061]

[0080] As used herein, the term "polyethylene" refers to a polymer made from at least 50% ethylene-derived units, preferably at least 70% ethylene-derived units, more preferably at least 80% ethylene-derived units, or 90% ethylene-derived units, or 95% ethylene-derived units, or even 100% ethylene-derived units. Thus, polyethylene can be a copolymer, including a homopolymer or terpolymer, with other monomeric units. The polyethylene described herein can include, for example, units derived from a comonomer, preferably an α-olefin, such as propylene, 1-butene, 1-pentene, 1-hexene, or 1-octene. Other embodiments can include ethacrylate or methacrylate.

[0062]

[0081] As used herein, the term "polypropylene" refers to any polymer, which may include homo-, impact, random, and isotactic propylene polymers. Preferably, the polypropylene used in the compositions described herein has a melting point greater than 110°C and contains at least 90% by weight of propylene units, including isotactic sequences of these units. Alternatively, the polypropylene may contain atactic or syndiotactic sequences. The polypropylene may be derived exclusively from propylene monomers (i.e., containing only propylene units) or may be derived primarily from propylene (greater than 80% propylene), with the remainder being olefins, particularly ethylene, and / or C4-C6. 10 It can be derived from an α-olefin.

[0063] As used herein, the term "polyolefin elastomer" or "POE" refers to an elastomer based on a polyethylene backbone. Ethylene-based POE has 65-91% ethylene and 9-35% linear alpha-olefins, such as butene-1, hexene-1, or octene-1. "Polyolefin elastomer" includes, but is not limited to, polyisobutylene (PIB), poly(a-olefin), ethylene propylene rubber (EPR), and ethylene propylene diene monomer (M-class) rubber (EPDM rubber).

[0064]

[0082] In one aspect, the present invention relates to a medical device / injection site for transferring fluid from a flexible medical container.

[0065]

[0083] 1a, there is shown a schematic diagram illustrating a cross section of an injection site 1100 design in accordance with a specific embodiment of the present invention. As shown in FIG. 1a, the injection site 1100 for transferring fluid from a pharmaceutical flexible container comprises an upper portion 1101, a middle portion 1104, a breakable area 1103, and an insert portion 1106.

[0066]

[0084] As shown in FIG. 1a, upper portion 1101 includes a first enclosure wall 1102 that encloses either a solid portion or a hollow portion having any shape as understood by those skilled in the art. For example, first enclosure wall 1102 may enclose a hollow portion to conserve material. In one embodiment, first enclosure wall 1102 encloses a first tunnel 1107. First tunnel 1107 can be any shape or size as understood by those skilled in the art. In one embodiment, first tunnel 1107 has a cylindrical shape. In one embodiment, first tunnel 1107 has a diameter of d1.

[0067]

[0085] The upper portion 1101 includes a first opening 1108 having any shape or size that allows access to the septum for puncturing the injection site with a needle. In one embodiment, the first opening 1108 has a first inner diameter d1 that gradually increases in size. Thus, the first opening 1108 has a first end and a second end. In one embodiment, the first end of the first opening 1108 has the same diameter as the first inner diameter d1. The second end of the first opening 1108 has a second inner diameter d2. In one embodiment, d2 is larger than d1.

[0068]

[0086] In one embodiment, the diameter d2 is within the range of 0.0001 to 1000 millimeters (mm), 0.001 to 500 mm, 0.005 to 200 mm, 0.01 to 150 mm, 0.05 to 100 mm, 0.1 to 50 mm, 0.2 to 40 mm, 0.3 to 30 mm, 0.4 to 20 mm, 0.5 to 15 mm, 0.6 to 14 mm, 0.7 to 13 mm, 0.8 to 12 mm, 0.9 to 11 mm, or 1 to 10 mm. Preferably, the diameter d2 is within the range of 1 to 10 mm, more preferably 2 to 9 mm, 3 to 8 mm, or 4 to 7 mm, and most preferably 4.5 mm.

[0069]

[0087] As shown in FIG. 1a, the central portion 1104 has a second opening 1111 connecting to the second end of the first opening 1108, and the second opening 1111 has a diameter size equal to the diameter size of the second inner diameter d2.

[0070]

[0088] In one embodiment, the sterility barrier seals both the first opening 1108 and the second opening 1111. For example, as shown in FIG. 1a, the sterility barrier seals both the first opening 1108 and the second opening 1111. Even after the breakable area 1103 is broken, the sterility barrier seals the second opening 1111 such that the septum 1112 is sealed within the first housing 1109.

[0071]

[0089] The central portion 1104 includes a second surrounding wall 1105 surrounding a first housing 1109 having a third inner diameter d3 for holding a septum 1112 .

[0072]

[0090] In one embodiment, the third inner diameter d3 has a size that is smaller than, the same as, or larger than the size of the septum 1112.

[0073]

[0091] In a preferred embodiment, the third inner diameter d3 is smaller than the diameter of the septum 1112 to keep the septum 1112 tightly fitted inside the first housing 1109.

[0074]

[0092] In one embodiment, the second enclosure 1105 is designed in shape and material to form the first housing 1109 with a size and shape such that the septum 1112 can be tightly held and sealed inside the walls of the second enclosure 1105. For example, in one embodiment, the first housing 1109 has walls that are the same size and shape as the septum 1112 such that the septum 1112 can be tightly held and sealed inside the walls of the first housing 1109.

[0075]

[0093] In one embodiment, the central portion 1104 includes a third opening 1113. In one embodiment, the third opening 1113 has a diameter size that is the same as the diameter size of the third inner diameter d3.

[0076]

[0094] As shown in FIG. 1 a, the breakable area 1103 is located between the top portion 1101 and the middle portion 1104 .

[0077]

[0095] In one embodiment, the breakable zone 1103 comprises walls that are thinner than the walls of the first enclosure wall 1102 and the walls of the second enclosure wall 1105. For example, the walls of the breakable zone 1103 are substantially thinner than the walls of the first enclosure wall 1102 and / or the walls of the second enclosure wall 1105. In one embodiment, the walls of the breakable zone 1103 are at least 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700%, 750%, 800%, 850%, 900%, 950% or 1000% thinner than the walls of the first enclosure wall 1102 and / or the walls of the second enclosure wall 1105. Preferably, the walls of the breakable area 1103 are at least 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700% or 750% thinner than the walls of the first enclosure wall 1102 and the second enclosure wall 1105.

[0078]

[0096] In one embodiment, the breakable area 1103 (e.g., 0.2 mm) is about 500% smaller than the wall (e.g., 1 mm). Depending on the material, the breakable area 1103 may be about 0.01 mm to 10 mm, 0.02 mm to 9 mm, 0.03 mm to 8 mm, 0.04 mm to 7 mm, 0.045 mm to 6 mm, or 0.05 mm to about 5 mm, preferably anywhere between 0.05 mm to 5 mm.

[0079]

[0097] In one embodiment, the breakable area 1103 is made of a material that is rigid enough to allow easy breaking of the breakable top 1101 (e.g., a breakable tamper-evident cap) and ductile enough to prevent particle formation after breaking.

[0080]

[0098] In one embodiment, the breakable area 1103 is made of a leak-proof material, thus preventing the septum 1112 from becoming contaminated with any liquid from the pharmaceutical flexible container. In a preferred embodiment, the surface of the septum 1112 does not require sterilization before first use.

[0081]

[0099] In another embodiment, the shape of the top portion 1101 and the dimensions of the breakable area 1103 may be modified to allow for easy removal of the breakable area 1103 by hand.

[0082]

[0100] In another embodiment, the breakable area 1103 may be tamper-evident, allowing the user to check the integrity of the product before use. In a preferred embodiment, the breakable area 1103 cannot be replaced once removed.

[0083]

[0101] In one embodiment, first enclosure wall 1102, second enclosure wall 1105 and breakable area 1103 are each made of the same or similar materials.

[0084]

[0102] For example, first surrounding wall 1102, second surrounding wall 1105, and breakable zone 1103 are each made of a blend of polyethylene (PE), polypropylene (PP), or a copolymer of ethylene and propylene with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA). In one embodiment, the polyolefin elastomer includes styrene-ethylene-butylene-styrene (SEBS). In one embodiment, the polyolefin elastomer is styrene-ethylene-butylene-styrene (SEBS).

[0085]

[0103] In one embodiment, first enclosure wall 1102, second enclosure wall 1105 and breakable zone 1103 are each made from a blend of polyethylene (PE) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0086]

[0104] In one embodiment, first enclosure wall 1102, second enclosure wall 1105 and breakable zone 1103 are each made from a blend of polypropylene (PP) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0087]

[0105] In one embodiment, first surrounding wall 1102, second surrounding wall 1105 and breakable area 1103 are each made from a blend of ethylene and propylene copolymer with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0088]

[0106] In one embodiment, first enclosure wall 1102, second enclosure wall 1105 and breakable zone 1103 are each made from a blend of polyethylene (PE) with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0089]

[0107] In one embodiment, first surrounding wall 1102, second surrounding wall 1105 and breakable zone 1103 are each made from a blend of polypropylene (PP) with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0090]

[0108] In one embodiment, first surrounding wall 1102, second surrounding wall 1105 and breakable area 1103 are each made from a blend of ethylene and propylene copolymer with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0091]

[0109] In one embodiment, first surrounding wall 1102, second surrounding wall 1105 and breakable area 1103 are all made of the same material.

[0092]

[0110] In a preferred embodiment, the first surrounding wall 1102, the second surrounding wall 1105, and the breakable area 1103 are all made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and / or ethylene-vinyl acetate (EVA). More preferably, the first surrounding wall 1102, the second surrounding wall 1105, and the breakable area 1103 are all made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

[0093]

[0111] In another embodiment, first enclosure wall 1102, second enclosure wall 1105, and breakable zone 1103 are each made of different blends of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and / or ethylene-vinyl acetate (EVA). For example, first enclosure wall 1102, second enclosure wall 1105, and breakable zone 1103 are each made of different blends of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

[0094]

[0112] 1a, septum 1112 is a self-sealing septum, i.e., septum 1112 can automatically seal itself against a small puncture (e.g., a needle puncture) without the usual processes or procedures for sealing.

[0095]

[0113] In one embodiment, the septum 1112 is made of an elastomeric material. For example, the septum 1112 is made of an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymers, polyurethane, vinyl, and mixtures thereof.

[0096]

[0114] In one embodiment, the septum 1112 is made of polyisoprene.

[0097]

[0115] As shown in FIG. 1a, the insert 1106 is attached to the central portion 1104 from the bottom of the central portion 1104.

[0098]

[0116] As shown in Figure 1a, the insert 1106 includes a third enclosure wall 1115 that surrounds a second tunnel 1110. The second tunnel 1110 can have any shape or size that allows fluid to flow from the monobag or MCB to the needle that pierces the associated membrane (e.g., membrane 1116).

[0099]

[0117] In one embodiment, the third enclosure wall 1115 is made from the same material as the first enclosure wall 1102 , the second enclosure wall 1105 and / or the breakable zone 1103 .

[0100]

[0118] In one embodiment, the third enclosure wall 1115 is made of a material that is different from the material of the first enclosure wall 1102 , the second enclosure wall 1105 and / or the breakable zone 1103 .

[0101]

[0119] For example, the third enclosure 1115 may be made of a blend of polyethylene (PE), polypropylene (PP), or a copolymer of ethylene and propylene with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA). In one embodiment, the polyolefin elastomer includes styrene-ethylene-butylene-styrene (SEBS). In one embodiment, the polyolefin elastomer is styrene-ethylene-butylene-styrene (SEBS).

[0102]

[0120] In one embodiment, the third enclosure 1115 may be made of a blend of polyethylene (PE) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0103]

[0121] In one embodiment, the third enclosure 1115 may be made of a blend of polypropylene (PP) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0104]

[0122] In one embodiment, the third enclosure 1115 may be made from a blend of ethylene and propylene copolymer with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0105]

[0123] In a preferred embodiment, the third enclosure 1115 may be made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS) and / or ethylene-vinyl acetate (EVA). More preferably, the third enclosure 1115 may be made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS) and ethylene-vinyl acetate (EVA).

[0106]

[0124] In one embodiment, the second tunnel 1110 has a fourth inner diameter d4. In a preferred embodiment, the fourth inner diameter d4 is smaller than the third inner diameter d3 of the septum 1112.

[0107]

[0125] In one embodiment, the top side of the third enclosure 1115 comprises a membrane 1116. In one embodiment, the top surface of the membrane 1116 seals the third opening 1113 in the second enclosure 1105.

[0108]

[0126] In one embodiment, membrane 1116 is made of the same material as inactive portion 1106. In one embodiment, membrane 1116 is made of a different material than the material of septum 1112.

[0109]

[0127] In one embodiment, the membrane 1116 is made of a blend of polyethylene (PE), polypropylene (PP), or a copolymer of ethylene and propylene with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA). In one embodiment, the polyolefin elastomer comprises styrene-ethylene-butylene-styrene (SEBS). In one embodiment, the polyolefin elastomer is styrene-ethylene-butylene-styrene (SEBS).

[0110]

[0128] In one embodiment, the membrane 1116 is molded together with other portions of the injection site 1100, such as the top portion 1101, the middle portion 1104, the breakable area 1103, and the insert 1106. Thus, the membrane 1116 is made of the same material as the material of the top portion 1101, the middle portion 1104, the breakable area 1103, and the insert 1106.

[0111]

[0129] In one embodiment, the membrane 1116 can prevent direct contact between the self-sealing septum 1112 and the solution (i.e., liquid or fluid). The membrane 1116 can also increase gas permeability, reduce water loss of the liquid or fluid, and protect the solution (i.e., liquid or fluid) from oxygen transfer. Additionally, the membrane 1116 can also reduce the risk of leaching substances from the septum 1112, which is typically made from polyisoprene rubber.

[0112]

[0130] In one embodiment, the presence of membrane 1116 prevents leaching of substances by avoiding direct contact between self-sealing septum 1112 and the solution.

[0113]

[0131] Additionally, membrane 1116 may be thin enough to allow for easy puncture.

[0114]

[0132] In one embodiment, the second surrounding wall 1105 of the central portion 1104 includes a convex structure near the third opening 1113, which fits into a concave structure on the top surface of the insert 1106. Figure lb shows an exemplary convex structure 1208 near the third opening 1209 of the second surrounding wall 1204. Figure ld shows an exemplary concave structure 1405 on the top surface 1404 of the insert 1400.

[0115]

[0133] As shown in FIG. 1a, the insert 1106 includes a fourth opening 1114 that allows fluid to be transferred between the infusion site 1100 and a flexible medical container (eg, a monobag or MCB).

[0116]

[0134] In one embodiment, the top portion 1101, the middle portion 1104, the frangible section 1103, and the insert portion 1106 are four portions of a single, integrated device. For example, the top portion 1101, the middle portion 1104, and the insert portion 1106 may be manufactured separately and later assembled into a single device injection site 1100.

[0117]

[0135] In another embodiment, the top portion 1101, the middle portion 1104, and the insert portion 1106 may be manufactured or molded separately. In one embodiment, the top portion 1101, the middle portion 1104, and the insert portion 1106 may be assembled into the injection site 1100 and then gamma irradiated for sterilization before it can be used.

[0118]

[0136] In one embodiment, the upper portion 1101 may include fins attached to the outer surface of the first enclosure 1102. For example, Figure 2a shows exemplary fins 2102 on the outer surface of the first enclosure of the upper portion 2101.

[0119]

[0137] In one embodiment, the insert 1106 may include a flange attached to the outer surface of the third surrounding wall 1115. For example, Figure 2a shows an exemplary flange 2106 against the outer surface of the third surrounding wall of the insert 2105. In one embodiment, adding a flange to the insert may make automatic insertion easier.

[0120]

[0138] In another embodiment, the first surrounding wall 1102 of the upper portion 1101 may surround a solid portion. For example, FIG. 1e shows an exemplary infusion site 1500 having an upper portion 1501 with a first surrounding wall 1502 surrounding a solid portion. The only difference between the infusion site 1100 of FIG. 1a and the infusion site 1500 of FIG. 1e is that the first surrounding wall 1502 of FIG. 1e surrounds a solid portion, while the first surrounding wall 1102 of FIG. 1a surrounds a hollow portion as described above.

[0121]

[0139] As shown in FIG. 1e, the upper portion 1501 also includes a first opening 1514 having an inner diameter d13, which is the same as the inner diameter of the second opening 1515 in the central portion 1504. The central portion 1504 also includes a second surrounding wall 1505 surrounding a first housing 1512 having a fourteenth inner diameter d14 for holding a septum 1513. The central portion 1504 also includes a third opening 1511 having the same diameter as the fourteenth inner diameter d14. The injection site 1500 further includes an insert portion 1506 including a third surrounding wall 1507 surrounding a tunnel 1509 having a fifteenth inner diameter d15. The upper side of the third surrounding wall 1507 includes a membrane 1510, the upper surface of which seals the third opening 1511 in the second surrounding wall 1505.

[0122]

[0140] Referring now to FIG. 1b, there is shown a cross-sectional schematic view of a portion of an injection site 1200 design according to FIG. 1a of the present invention.

[0123]

[0141] As shown in FIG. 1b, the injection site 1200 comprises an upper portion 1201, a middle portion 1204, and a frangible area 1203 between the upper portion 1201 and the middle portion 1204.

[0124]

[0142] The upper portion 1201 includes a first surrounding wall 1202 that surrounds either a solid portion or a hollow portion having any shape as understood by those skilled in the art. For example, the first surrounding wall 1202 may surround a hollow portion to conserve material. In one embodiment, the first surrounding wall 1202 surrounds a first tunnel 1205. As described herein, the first tunnel 1205 can have any shape as understood by those skilled in the art. In one embodiment, the first tunnel 1205 has a cylindrical shape. In one embodiment, the first tunnel 1205 has a fourth inner diameter d4. The fourth inner diameter d4 is similar to the first inner diameter d1. Accordingly, d4 is as defined herein in this disclosure and understood by those skilled in the art.

[0125]

[0143] The upper portion 1201 includes a first opening 1206 having a gradually expanding inner diameter beginning at a fourth inner diameter d4. Accordingly, the first opening 1206 has a first end and a second end. In one embodiment, the first end of the first opening 1206 has a diameter size equal to the diameter size of the fourth inner diameter d4. The second end of the first opening 1206 has a fifth inner diameter d5. In one embodiment, d5 is larger than d4. The fifth inner diameter d5 is similar to the second inner diameter d2. Accordingly, d5 is defined herein in this disclosure and understood by those skilled in the art.

[0126]

[0144] As shown in Figure lb, the central portion 1204 includes a second opening 1210 that connects to a second end of the first opening 1206. In one embodiment, the second opening 1210 has a diameter size that is the same as the diameter size of the fifth inner diameter.

[0127]

[0145] In one embodiment, the sterility barrier seals both the first opening 1206 and the second opening 1210. For example, as shown in FIG. 1b, the sterility barrier seals both the first opening 1206 and the second opening 1210. Even after the breakable section 1203 is broken, the sterility barrier seals the second opening 1210 such that a septum (not shown) is sealed within the first housing 1207.

[0128]

[0146] The central portion 1204 includes a second surrounding wall 1211 surrounding a first housing 1207 having an inner diameter suitable for holding a septum (not shown).

[0129]

[0147] As defined in this disclosure, second enclosure 1211 is specially designed in its shape and material to form first housing 1207 having a particular size and shape such that the septum can be tightly held and sealed inside the walls of second enclosure 1211. For example, in one embodiment, first housing 1207 has walls that are the same size and shape as the septum such that the septum can be tightly held and sealed inside the walls of first housing 1207.

[0130]

[0148] The central portion 1204 includes a third opening 1209 .

[0131]

[0149] As shown in FIG. 1b, the breakable area 1203 is located between the top portion 1201 and the middle portion 1204.

[0132]

[0150] The breakable zone 1203 is defined in the present disclosure. For example, the breakable zone 1203 comprises walls that are thinner than the walls of the first enclosure wall 1202. In one embodiment, the walls of the breakable zone 1203 are substantially thinner than the walls of the first enclosure wall 1202. In one embodiment, the walls of the breakable zone 1203 are at least 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700%, 750%, 800%, 850%, 900%, 950%, or 1000% thinner than the walls of the first enclosure wall 1202. Preferably, the walls of the breakable area 1203 are at least 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700% or 750% thinner than the walls of the first enclosure wall 1202.

[0133]

[0151] In one embodiment, the breakable area 1203 (e.g., 0.2 mm) is about 500% smaller than the wall (e.g., 1 mm). Depending on the material, the breakable area 1203 may be about 0.01 mm to 10 mm, 0.02 mm to 9 mm, 0.03 mm to 8 mm, 0.04 mm to 7 mm, 0.045 mm to 6 mm, or 0.05 mm to about 5 mm, preferably anywhere between 0.05 mm to 5 mm.

[0134]

[0152] In one embodiment, the breakable area 1203 is made of a material that is rigid enough to allow easy breaking of the breakable tamper-evident cap and ductile enough to prevent particle formation after breaking.

[0135]

[0153] In one embodiment, the breakable area 1203 is made of a leak-proof material, thus preventing the septum (shown here) from becoming contaminated with any liquid from the pharmaceutical flexible container. In a preferred embodiment, the surface of the septum does not require sterilization before first use.

[0136]

[0154] In another embodiment, the shape of the upper portion 1201 and the dimensions of the breakable area 1203 may be adjusted so that the breakable area 1203 can be easily removed by hand.

[0137]

[0155] In another embodiment, the breakable area 1203 may be tamper-evident, allowing the user to check the integrity of the product before use. In a preferred embodiment, the breakable area 1203 cannot be replaced once removed.

[0138]

[0156] In one embodiment, the central portion 1204 comprises a convex structure 1208 near the third opening 1209 of the second surrounding wall 1204 .

[0139]

[0157] In one embodiment, first enclosure wall 1202, second enclosure wall 1211 and breakable area 1203 are each made of the same or similar materials.

[0140]

[0158] For example, first surrounding wall 1202, second surrounding wall 1211, and breakable zone 1203 are each made of a blend of polyethylene (PE), polypropylene (PP), or a copolymer of ethylene and propylene with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA). In one embodiment, the polyolefin elastomer includes styrene-ethylene-butylene-styrene (SEBS). In one embodiment, the polyolefin elastomer is styrene-ethylene-butylene-styrene (SEBS).

[0141]

[0159] In one embodiment, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are each made from a blend of polyethylene (PE) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0142]

[0160] In one embodiment, first enclosure wall 1202, second enclosure wall 1211 and breakable zone 1203 are each made from a blend of polypropylene (PP) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0143]

[0161] In one embodiment, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are each made from a blend of ethylene and propylene copolymer with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0144]

[0162] In one embodiment, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are each made from a blend of polyethylene (PE) with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0145]

[0163] In one embodiment, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are each made from a blend of polypropylene (PP) with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0146]

[0164] In one embodiment, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are each made from a blend of ethylene and propylene copolymer with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0147]

[0165] In one embodiment, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are all made of the same material.

[0148]

[0166] In a preferred embodiment, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are all made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS) and / or ethylene-vinyl acetate (EVA). More preferably, first surrounding wall 1202, second surrounding wall 1211 and breakable area 1203 are all made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS) and ethylene-vinyl acetate (EVA).

[0149]

[0167] In another embodiment, first surrounding wall 1202, second surrounding wall 1211, and breakable zone 1203 are each made of different blends of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and / or ethylene-vinyl acetate (EVA). For example, first surrounding wall 1202, second surrounding wall 1211, and breakable zone 1203 are each made of different blends of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

[0150]

[0168] Referring now to Figure 1c, there is shown a schematic cross-sectional view of a portion of an injection site design according to Figure 1a of the present invention. Specifically, Figure 1c shows a cross-section of a septum 1300.

[0151]

[0169] In one embodiment, septum 1300 is a self-sealing septum, e.g., septum 1300 can automatically seal itself against a small puncture (e.g., a needle puncture) without the usual processes or procedures for sealing.

[0152]

[0170] In one embodiment, the septum 1300 is made of an elastomeric material. For example, the septum 1300 is made of an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymers, polyurethane, vinyl, and mixtures thereof.

[0153]

[0171] In one embodiment, the septum 1300 is made of polyisoprene.

[0154]

[0172] Figure 1d shows a schematic cross-sectional view of a portion of the injection site design according to Figure 1a of the present invention. In particular, Figure 1d shows a cross-section of the insert 1400.

[0155]

[0173] As shown in FIG. 1 d , the insert 1400 includes a third surrounding wall 1401 surrounding the second tunnel 1402 .

[0156]

[0174] In one embodiment, the top side of the third enclosure 1401 comprises a membrane 1403. In one embodiment, an upper surface 1404 of the membrane 1403 can seal the third opening 1209 in the second enclosure 1211.

[0157]

[0175] Membrane 1403 may be made of materials as defined in this disclosure or any other material understood by one of ordinary skill in the art.

[0158]

[0176] For example, in one embodiment, membrane 1403 is made of the same material as the material of the corresponding inactive portion (e.g., 1400 in FIG. 1d). In one embodiment, membrane 1403 is made of a different material than the material of the corresponding septum (e.g., 1300 in FIG. 1c).

[0159]

[0177] In one embodiment, membrane 1403 is made of a blend of polyethylene (PE), polypropylene (PP), or a copolymer of ethylene and propylene with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA). In one embodiment, the polyolefin elastomer comprises styrene-ethylene-butylene-styrene (SEBS). In one embodiment, the polyolefin elastomer is styrene-ethylene-butylene-styrene (SEBS).

[0160]

[0178] In one embodiment, membrane 1403 is molded together with other portions of the corresponding injection site (e.g., 1100 in FIG. 1a), such as the corresponding top portion (e.g., 1101 in FIG. 1a), the corresponding middle portion (e.g., 1104 in FIG. 1a), the corresponding breakable area (e.g., 1103 in FIG. 1a), and the corresponding insert (e.g., 1400 in FIG. 1d). Thus, membrane 1403 is made of the same material as the material of the corresponding top portion (e.g., 1101 in FIG. 1a), the corresponding middle portion (e.g., 1104 in FIG. 1a), the corresponding breakable area (e.g., 1103 in FIG. 1a), and the corresponding insert (e.g., 1400 in FIG. 1d).

[0161]

[0179] The third enclosure 1401 may be made of a blend of polyethylene (PE), polypropylene (PP), or a copolymer of ethylene and propylene with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA). In one embodiment, the polyolefin elastomer comprises styrene-ethylene-butylene-styrene (SEBS). In one embodiment, the polyolefin elastomer is styrene-ethylene-butylene-styrene (SEBS).

[0162]

[0180] In one embodiment, the third enclosure 1401 may be made of a blend of polyethylene (PE) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0163]

[0181] In one embodiment, the third enclosure 1401 may be made of a blend of polypropylene (PP) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0164]

[0182] In one embodiment, the third enclosure 1401 may be made of a blend of ethylene and propylene copolymer with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0165]

[0183] In a preferred embodiment, the third enclosure 1401 may be made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS) and / or ethylene-vinyl acetate (EVA). More preferably, the third enclosure 1401 may be made of a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS) and ethylene-vinyl acetate (EVA).

[0166]

[0184] FIG. 1 d shows an exemplary concave structure 1405 on the top surface 1404 of the insert 1400 .

[0167]

[0185] As shown in FIG. 1d, the insert 1400 includes a fourth opening 1406 that allows fluid to pass between the injection site and a flexible medical container (eg, a monobag or MCB).

[0168]

[0186] 2a and 2b, there are shown schematic diagrams of injection site 2100 / 2200 designs according to certain embodiments of the present invention.

[0169]

[0187] As shown in FIG. 2a, the injection site 2100 comprises an upper portion 2101 with fins 2102, a central portion 2104 that holds a septum (not shown), a breakable area 2103 between the upper portion 2101 and the central portion 2104, and an insert portion 2105 with a flange 2106.

[0170]

[0188] As shown in FIG. 2b, injection site 2200 comprises an upper portion 2201 with fins 2202, a middle portion 2204 that holds a septum (not shown), and a breakable area 2203 between upper portion 2201 and middle portion 2204.

[0171]

[0189] Details of the top portion 2101 / 2201, middle portion 2104 / 2204, frangible areas 2103 / 2203 and insert portion 2105 are described in this disclosure.

[0172]

[0190] In one embodiment, the addition of a flange 2106 to the insert 2105 can make the injection site easier to automatically insert.

[0173]

[0191] In one embodiment, fins 2102 / 2202 may be added to the top portion 2101 / 2201 to facilitate handling of the breakable portion (eg, top portion 2101 / 2201).

[0174]

[0192] Referring now to FIG. 2c, there is shown a schematic diagram of a design of a portion of an injection site 2300 according to a particular embodiment of the present invention.

[0175]

[0193] As shown in FIG. 2c, injection site 2300 comprises an upper portion 2301, a middle portion 2302 that holds a septum (not shown), and a breakable area 2303 between upper portion 2301 and middle portion 2302.

[0176]

[0194] Details of the top portion 2301, middle portion 2302 and frangible area 2303 are described in this disclosure.

[0177]

[0195] Referring now to FIG. 2d, there is shown a cross-sectional schematic view of a portion of an injection site 2400 design in accordance with a specific embodiment of the present invention.

[0178]

[0196] As shown in FIG. 2d, injection site 2400 comprises a top portion 2401, a middle portion 2402 that holds a septum (not shown), and a breakable area 2403 between top portion 2401 and middle portion 2402.

[0179]

[0197] Details of the top portion 2401, middle portion 2402 and frangible area 2403 are described in this disclosure.

[0180]

[0198] For example, upper portion 2401 includes first surrounding wall 2404 enclosing either a solid portion or a hollow portion having any shape as understood by one skilled in the art. For example, first surrounding wall 2404 may enclose a hollow portion to conserve material. In one embodiment, first surrounding wall 2404 encloses first tunnel 2405. As described herein, first tunnel 2405 can be any shape as understood by one skilled in the art. In one embodiment, first tunnel 2405 has a cylindrical shape. In one embodiment, first tunnel 2405 has a sixth inner diameter d6. Sixth inner diameter d6 is similar to first inner diameter d1. Thus, the parameter d6 is defined herein in this disclosure and understood by one skilled in the art.

[0181]

[0199] The upper portion 2401 includes a first opening 2407 having a variety of shapes (e.g., circular, square, or other shapes). In one embodiment, the first opening 2407 has an inner diameter that gradually expands from a sixth inner diameter d6. Thus, the first opening 2407 has a first end and a second end. In one embodiment, the first end of the first opening 2407 has a diameter size that is the same as the diameter size of the sixth inner diameter d6. The second end of the first opening 2407 has a seventh inner diameter d7. In one embodiment, d7 is larger than d6. The seventh inner diameter d7 is similar to the second inner diameter d2. Thus, d7 is as defined herein in this disclosure and understood by those skilled in the art.

[0182]

[0200] As shown in FIG. 2d, the central portion 2402 has a second opening 2408 connecting to the second end of the first opening 2407, and the second opening 2408 has the same diameter size as the diameter size of the seventh inner diameter d7.

[0183]

[0201] In one embodiment, a sterility barrier (not shown) seals both first opening 2407 and second opening 2408. For example, even after breakable section 2403 is broken, the sterility barrier seals second opening 2408 such that a septum (not shown) is sealed within first housing 2406.

[0184]

[0202] The central portion 2402 comprises a second surrounding wall 2410 surrounding a first housing 2406 having an eighth inner diameter d8 suitable for holding a septum (not shown).

[0185]

[0203] As defined in this disclosure, second enclosure 2410 is specially designed in its shape and material to form first housing 2406 having a particular size and shape such that the septum can be tightly held and sealed inside the walls of second enclosure 2410 (i.e., first housing 2406). For example, in one embodiment, first housing 2406 has walls that are the same size and shape as the septum such that the septum can be tightly held and sealed inside the walls of first housing 2406.

[0186]

[0204] The central portion 2402 includes a third opening 2409 .

[0187]

[0205] As shown in FIG. 2d, the third opening 2409 has an inner diameter that gradually expands from an eighth inner diameter d8. Thus, the third opening 2409 has a first end and a second end. In one embodiment, the first end of the third opening 2409 has a diameter size equal to the diameter of the eighth inner diameter d8. The second end of the third opening 2409 has a ninth inner diameter d9. In one embodiment, d9 is greater than d8.

[0188]

[0206] As shown in FIG. 2d, the breakable area 2403 is located between the top portion 2401 and the middle portion 2402.

[0189]

[0207] Breakable zone 2403 is defined throughout this disclosure. For example, breakable zone 2403 comprises walls that are thinner than the walls of first enclosure wall 2404 and / or second enclosure wall 2410. In one embodiment, the walls of breakable zone 2403 are substantially thinner than the walls of first enclosure wall 2404 and / or second enclosure wall 2410. In one embodiment, the walls of the breakable area 2403 are at least 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700%, 750%, 800%, 850%, 900%, 950% or 1000% thinner than the walls of the first enclosure wall 2404. Preferably, the walls of the breakable area 2403 are at least 100%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700% or 750% thinner than the walls of the first enclosure wall 2404 and the second enclosure wall 2410.

[0190]

[0208] In one embodiment, the breakable area 2403 (e.g., 0.2 mm) is about 500% smaller than the wall of the first enclosure 2404 (e.g., 1 mm) and / or the wall of the second enclosure 2410. Depending on the material, the breakable area 2403 may be about 0.01 mm to 10 mm, 0.02 mm to 9 mm, 0.03 mm to 8 mm, 0.04 mm to 7 mm, 0.045 mm to 6 mm, or 0.05 mm to about 5 mm, preferably anywhere between 0.05 mm to 5 mm.

[0191]

[0209] In one embodiment, the thinner walls of the breakable area 2403 can be achieved by removing a portion of the outer wall and / or expanding the corresponding interior space (i.e., increasing d7 to remove a portion of the inner wall).

[0192]

[0210] FIG. 2d provides an example of creating thinner walls in the breakable area 2403 by both removing a portion of the outer wall and expanding the corresponding interior space (i.e., increasing d7 to remove a portion of the inner wall).

[0193]

[0211] In one embodiment, the breakable area 2403 is made of a material that is rigid enough to allow easy breaking of the breakable tamper-evident cap and ductile enough to prevent particle formation after breaking.

[0194]

[0212] In one embodiment, the breakable area 2403 is made of a leak-proof material, thus preventing the septum (shown here) from becoming contaminated with any liquid from the pharmaceutical flexible container. In a preferred embodiment, the surface of the septum does not require sterilization before first use.

[0195]

[0213] In another embodiment, the shape of the top portion 2401 and the dimensions of the breakable area 2403 may be adjusted so that the top portion 2401 can be easily removed by hand after the breakable area 2403 is broken.

[0196]

[0214] In another embodiment, the breakable area 2403 may be tamper-evident, allowing the user to check the integrity of the product before use. In a preferred embodiment, the breakable area 2403 cannot be replaced once removed.

[0197]

[0215] In one embodiment, first enclosure wall 2404, second enclosure wall 2410 and frangible area 2403 are each made of the same or similar materials as defined throughout this disclosure.

[0198]

[0216] Referring now to FIG. 2e, there is shown a cross-sectional schematic view of a portion of an injection site 2500 design in accordance with a specific embodiment of the present invention.

[0199]

[0217] As shown in FIG. 2e, injection site 2500 comprises a top portion 2501, a middle portion 2502 that holds a septum (not shown), and a breakable area 2503 between top portion 2501 and middle portion 2502.

[0200]

[0218] The upper portion 2501 includes a first surrounding wall 2504 that surrounds either a solid portion or a hollow portion having any shape as understood by those skilled in the art. For example, the first surrounding wall 2504 may surround a hollow portion to conserve material. In one embodiment, the first surrounding wall 2504 surrounds a first tunnel 2505. As described herein, the first tunnel 2505 can have any shape as understood by those skilled in the art. In one embodiment, the first tunnel 2505 has a cylindrical shape. In one embodiment, the first tunnel 2505 has a tenth inner diameter d10. The tenth inner diameter d10 is similar to the first inner diameter d1. Thus, the parameter d10 is defined herein in this disclosure and understood by those skilled in the art.

[0201]

[0219] The upper portion 2501 includes a first opening 2507 having a diameter size equal to the diameter size of the tenth inner diameter d10.

[0202]

[0220] As shown in FIG. 2e, the central portion 2502 has a second opening 2508 connected to the first opening 2507, and the second opening 2508 has the same diameter size as the diameter size of the tenth inner diameter d10.

[0203]

[0221] The central portion 2502 comprises a second surrounding wall 2510 surrounding a first housing 2506 having an eleventh inner diameter d11 suitable for holding a septum (not shown).

[0204]

[0222] The central portion 2502 includes a third opening 2509 .

[0205]

[0223] As shown in FIG. 2e, the third opening 2509 has an inner diameter that gradually expands from an eleventh inner diameter d11. Thus, the third opening 2509 has a first end and a second end. In one embodiment, the first end of the third opening 2509 has a diameter size equal to the diameter of the eleventh inner diameter d11. The second end of the third opening 2509 has a twelfth inner diameter d12. In one embodiment, d12 is larger than d11.

[0206]

[0224] As shown in FIG. 2e, the breakable area 2503 is located between the top portion 2501 and the middle portion 2502.

[0207]

[0225] Breakable zone 2503 is defined throughout this disclosure. For example, the thinner walls of breakable zone 2503 can be achieved by removing a portion of the outer wall and / or expanding the corresponding interior space (i.e., removing a portion of the inner wall).

[0208]

[0226] FIG. 2e provides an example of removing a portion of the exterior wall to create a thinner wall in the breakable area 2503.

[0209]

[0227] Referring now to FIG. 3a, there is shown a cross-sectional schematic diagram of an injection site 3100 design in accordance with a specific embodiment of the present invention.

[0210]

[0228] As shown in FIG. 3a, the injection site 3100 comprises an upper portion 3101 with fins 3102, a central portion 3104 that holds a septum (not shown), an insert portion 3105, and a breakable area 3103 between the upper portion 3101 and the insert portion 3105.

[0211]

[0229] The upper portion 3101 includes a first enclosure wall 3112 that encloses either a solid portion or a hollow portion having any shape as would be understood by one of ordinary skill in the art. For example, the first enclosure wall 3112 may enclose a hollow portion to conserve material. In one embodiment, the first enclosure wall 3112 encloses the first tunnel 3106 and a first opening 3107 at the bottom of the first enclosure wall 3112.

[0212]

[0230] In one embodiment, the upper portion 3101 comprises fins 3102 attached to the outer surface of the first enclosure wall 3112 .

[0213]

[0231] As shown in FIG. 3 a , the central portion 3104 is located inside the first tunnel 3106 near the bottom of the first enclosure wall 3112 .

[0214]

[0232] The central portion 3104 includes a second enclosure wall 3113 that surrounds a first housing 3108 for holding a septum (not shown).

[0215]

[0233] In one embodiment, a sterility barrier (not shown) seals the top of the first housing 3108. For example, even after removing the top portion 3101 after breaking the breakable section 3103, the sterility barrier seals the top of the first housing 3108 such that a septum (not shown) is sealed within the first housing 3108.

[0216]

[0234] The central portion 3104 further comprises a membrane 3109 at the bottom of the second surrounding wall 3113 .

[0217]

[0235] Membrane 3109 is described and defined throughout this disclosure.

[0218]

[0236] 3a, the insert 3105 includes a third enclosure wall 3114 that surrounds the second tunnel 3110. The insert 3105 includes a second opening 3111 at the top of the second tunnel 3110, and the bottom surface of the membrane 3109 seals the second opening 3111 in the third enclosure wall 3114.

[0219]

[0237] As shown in FIG. 3 a, the frangible area 3103 is located between the top portion 3101 and the insert portion 3105 .

[0220]

[0238] In one embodiment, the breakable area 3103 and the top portion 3101 form a twist-off breakable portion to protect the surface of a septum (not shown). In another embodiment, the breakable area 3103 is fully defined in this disclosure.

[0221]

[0239] Referring now to FIG. 3b, there is shown a cross-sectional schematic diagram of another design of an injection site 3200 in accordance with certain embodiments of the present invention.

[0222]

[0240] As shown in FIG. 3b, injection site 3200 comprises a top portion 3201 that holds a septum 3203, a lid 3202 that covers septum 3203, and an insert portion 3208 that includes a wide, flat base 3204 that seals directly to the film.

[0223]

[0241] In one embodiment, the top 3201 includes a first enclosure 3212 that surrounds a first housing 3205 for holding a septum 3203. As described in more detail in this disclosure, the septum 3203 is a self-sealing septum. For example, the septum 3203 is made of an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymer, polyurethane, vinyl, and mixtures thereof. In a preferred embodiment, the septum 3203 is made of polyisoprene.

[0224]

[0242] In one embodiment, the first enclosure 3212 is designed in shape and material to form the first housing 3205 with a size and shape such that the septum 3203 can be tightly held and sealed inside the walls of the first enclosure 3212. For example, in one embodiment, the first housing 3205 has walls that are the same size and shape as the septum 3203 such that the septum 3203 can be tightly held and sealed inside the walls of the first housing 3205.

[0225]

[0243] As shown in FIG. 3 b , the first housing 3205 includes a first opening 3206 at the top of the first housing 3205 .

[0226]

[0244] The lid 3202 covers and seals the first opening 3206 of the first housing 3205. In one embodiment, the lid 3202 may be assembled to the top of the first housing 3205 by heating or gluing, or any other method understood by one of ordinary skill in the art.

[0227]

[0245] In one embodiment, a sterility barrier (not shown) seals both first openings 3206. For example, even after removing lid 3202, the sterility barrier seals first openings 3206 such that a septum (not shown) is sealed within first housing 3205.

[0228]

[0246] As shown in Figure 3b, top portion 3201 includes a membrane 3207 at the bottom of first housing 3205. Membrane 3207 seals septum 3203 to the inside of first housing 3205 so that septum 3203 does not come into contact with any liquid from first tunnel 3208 in insert 3208 below top portion 3201.

[0229]

[0247] Details of membrane 3207 are described throughout this disclosure.

[0230]

[0248] The insert 3208 comprises a second enclosure wall 3209 that surrounds the first tunnel 3210. The insert 3208 further comprises a second opening 3211 at the top of the first tunnel 3210. In one embodiment, the bottom surface of the membrane 3207 seals the second opening of the insert 3208.

[0231]

[0249] In one embodiment, septum 3203 is a self-sealing septum. For example, septum 3203 is made of an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymer, polyurethane, vinyl, and mixtures thereof. In a preferred embodiment, septum 3203 is made of polyisoprene.

[0232]

[0250] In one embodiment, the top 3201, lid 3202, and insert 3208 are three parts of a single, integrated device. For example, the top 3201, lid 3202, and insert 3208 may be manufactured separately and later molded into a single device medical device 3200.

[0233]

[0251] In another embodiment, the top portion 3201, lid 3202, and insert 3208 may be manufactured or molded separately. In one embodiment, the top portion 3201, middle portion 3202, and insert 3208 may be assembled into the injection site 3200 and then gamma irradiated for sterilization before it can be used.

[0234]

[0252] In one embodiment, the insert 3208 includes a wide, flat base 3204 that is sealed directly to the film.

[0235]

[0253] For example, Figure 3c shows a medical device 3300 comprising a top portion 3301 that holds a septum (not shown), a lid 3302 that covers the septum, and an insert portion 3303 that includes a wide, flat base 3204 that seals directly to the film. In one embodiment, the medical device can be used in an access port system that combines both an administration site and an infusion site.

[0236]

[0254] In another embodiment, the injection site may include a cap, such as a "flip-top" cap, instead of introducing a breakable section to remove the top of the device before use.

[0237]

[0255] In one embodiment, the "flip-top" cap design of the present disclosure allows for simple manufacturing by 2k molding into a single device, ensuring easy sterilization of the injection site (IS).

[0238]

[0256] The injection site (including the second enclosure surrounding the first housing that holds the septum) must be sterilized. In its current form (as in the present application), the preferred method of sterilization is typically gamma sterilization, as the elastomeric septum could otherwise be damaged. The "flip-top" cap design of the present disclosure provides a cover for the second enclosure with the first housing that holds the septum. In such a configuration, the septum material is sufficiently protected to allow for heat sterilization, which is preferred because it often allows for in-line sterilization during manufacturing and is less expensive.

[0239]

[0257] Additionally, heat sterilization can result in a soft adhesive effect, i.e., the cap and injection site body are fused by heat without damage to the septum. The adhesive can occur between the inner central portion of the cap, which may have a slightly bulging appearance, and the lower septum when the cap sits on the injection site body. Alternatively, the adhesive can occur between the inside of the rim of the cap and the outer upper rim of the injection site body.

[0240]

[0258] Referring now to FIG. 4a, there is shown a schematic cross-sectional view of another design of injection site 4100 comprising cap 4101, central portion 4104 that holds a septum, and insert portion 4106, in accordance with certain embodiments of the present invention.

[0241]

[0259] 4a, instead of a breakable section to remove the top of the device as described above, the injection site 4100 includes a cap 4101 (e.g., a "flip-top" cap) connected to the body of the injection site 4100 by a hinge 4102. In one embodiment, the hinge 4102 is breakable.

[0242]

[0260] The central portion 4104 and the cap 4101 (when closed over the top opening 4107) form a first enclosure 4105 having a diameter d13 for holding a septum (not shown).

[0243]

[0261] As shown in FIG. 4a, the insert 4106 comprises a third surrounding wall 4115 surrounding a second tunnel 4110 having a diameter d14.

[0244]

[0262] In one embodiment, the insert 4106 comprises fins 4103 .

[0245]

[0263] In one embodiment, the upper side of the third enclosure wall 4115 comprises a membrane 4116. In one embodiment, the upper surface of the membrane 4116 seals the third opening 4113 in the second enclosure wall 4105.

[0246]

[0264] The second tunnel 4110 can have any shape or size that allows fluid to flow from the monobag or MCB to the needle that pierces the associated membrane (eg, membrane 4116).

[0247]

[0265] In one embodiment, the cap 4101 is molded together with the body of the injection site 4100 as one piece, and the cap 4101 is connected to the body of the injection site 4100 by a hinge 4102 .

[0248]

[0266] Thus, the cap 4101 and hinge 4102 are made from the same material as the body. Polypropylene (PP) may be preferably used for this design of injection site 4100, as this material allows for slight thermal bonding between (i) the cap and the body, and (ii) the septum and the inner wall of the housing in which it is located. Other materials may be envisioned, but PP is the best alternative currently available.

[0249]

[0267] In one embodiment, the septum may then be introduced into the manufacturing process in the next step, i.e., the septum material is filled into the first housing of the body. After the septum material is filled into the first housing of the body, the cap 4101 is closed, causing the hinge 4102 to break and sealing and protecting the septum.

[0250]

[0268] Referring now to FIG. 4b, a schematic diagram shows another design of injection site 4200 according to certain embodiments of the present invention, comprising cap 4201 (closed), central portion 4204 that holds a septum, and insert portion 4206.

[0251]

[0269] Additionally, FIG. 4c is a schematic diagram illustrating another design of injection site 4300 according to certain embodiments of the present invention, comprising cap 4301 (open), central portion 4304 that holds a septum, and insert portion 4306.

[0252]

[0270] FIG. 4d is a schematic diagram illustrating another design of injection site 4400 according to certain embodiments of the present invention, comprising cap 4401 (open), central portion 4404 that holds a septum, and insert portion 4406.

[0253]

[0271] FIG. 4e is a schematic diagram illustrating another design of an injection site 4500 according to certain embodiments of the present invention, comprising a cap 4501 (closed), a central portion 4504 that holds a septum, and an insert portion 4506.

[0254]

[0272] FIG. 4f is a schematic diagram illustrating another design of an injection site 4600 according to certain embodiments of the present invention, comprising a cap 4601 (closed), a central portion 4604 that holds a septum, and an insert portion 4606.

[0255]

[0273] Referring now to FIG. 4g, a schematic diagram shows a cross section of another design of injection site 4700 according to a specific embodiment of the present invention, comprising cap 4701 (closed), central portion 4704 holding septum 4705, and insert portion 4706.

[0256]

[0274] As shown in FIG. 4 g , the central portion 4704 and the cap 4701 (closed) form a second enclosure 4705 having a diameter d 15 for holding a septum 4707 .

[0257]

[0275] Additionally, as shown in FIG. 4g, the insert 4706 includes a third surrounding wall 4715 surrounding a second tunnel 4710 having a diameter d16.

[0258]

[0276] In one embodiment, insert 4706 comprises fins 4703 .

[0259]

[0277] In one embodiment, the top side of the third enclosure wall 4715 comprises a membrane 4716. In one embodiment, the top surface of the membrane 4716 seals the third opening 4713 in the second enclosure wall 4705.

[0260]

[0278] The second tunnel 4710 can have any shape or size that allows fluid to flow from the monobag or MCB to the needle that pierces the associated membrane (eg, membrane 4716).

[0261]

[0279] Referring now to FIG. 4h, a schematic diagram shows another design of injection site 4800 according to certain embodiments of the present invention, comprising cap 4801 (closed), central portion 4804 that holds a septum, and insert portion 4806.

[0262]

[0280] As shown in FIG. 4h, insert 4806 also includes fins 4803.

[0263]

[0281] In one embodiment, once the cap is closed, the body of the injection site (e.g., 4100-4800) may then be sterilized, preferably heat sterilized, which can result in (i) slight heat-induced adhesion between the cap and the body, either between the inner periphery of the cap and the outer periphery of the housing, or between the inner protrusion of the cap that adheres to the septum.

[0264]

[0282] Additionally, the heat during the sterilization process can also result in additional adhesion between the septum (material) and the inner wall (material) of the housing, which is another benefit of using heat sterilization. In one embodiment, the additional adhesion increases the overall stability of the instrument without an additional process step.

[0265]

[0283] In some embodiments, the breaking of the hinge (e.g., 4702 in FIG. 4g) may be intentional. Thus, when removed for use in the clinic, the cap (e.g., 4701) may not be intended to be reused, i.e., placed back onto the body of the injection site (e.g., 4700).

[0266]

[0284] If the hinge is not broken, the cap remains connected to the housing, similar to a cap designed to be put on and taken off several times.

[0267]

[0285] To create a breakable hinge (e.g., 4702 in Figure 4g), the overall length of the hinge is shortened such that when the open cap (after 2K molding) moves through a 180° angular movement to close the injection site body, the hinge (e.g., 4702 in Figure 4g) may not be long enough to support the full movement and will tear or break from the injection site body.

[0268]

[0286] Thus, the length of the breakable hinge (e.g., 4702 in FIG. 4g) can be adapted to the overall design. The optimal length of the breakable hinge (e.g., 4702 in FIG. 4g) can also depend on where the hinge connects to the infusion site body.

[0269]

[0287] In either case, however, the cap must be short enough to break or tear when it is pressed over the injection site body.

[0270]

[0288] In one embodiment, the thickness of the hinge should not exceed 0.5 mm for reliable breaking of the hinge, for example to avoid damage to the cap or body of the device due to loading of the hinge, cap, and / or body. In one embodiment, the thickness should preferably be in the range of 0.3-0.5 mm.

[0271]

[0289] Another way to achieve a breakable hinge is to move the connection site between the hinge and the infusion site body upwards towards the upper rim of the second enclosure.

[0272]

[0290] The distance between the point of connection with the injection site body and the upper rim or periphery of the housing must be less than the height of the cap so that when the cap is pressed onto the body during manufacture, the cap automatically breaks or pulls apart the hinge at the point where the hinge is connected to the injection site body.

[0273]

[0291] In one embodiment, the injection sites 4100-4800 and their components may be made from any of the materials described in this disclosure.

[0274]

[0292] In another aspect, the present invention relates to a method of manufacturing the medical device / infusion site described in this disclosure for transferring fluids from a flexible medical container.

[0275]

[0293] Infusion site 1100 is used below as an example of manufacture. Other medical devices / infusion sites of the present invention can be similarly manufactured.

[0276]

[0294] In one embodiment, a method of manufacturing the present medical device / infusion site, such as infusion site 1100, comprises the following steps: 1. manufacturing the individual parts of the injection site 1100, including the top portion 1101, the middle portion 1104, the septum 1112, the middle portion 1104 and the insert portion 1106; 2. Assembling the top portion 1101 and the middle portion 1104 into part 1200 to form a breakable area 1103 between the top portion 1101 and the middle portion 1104; 3. inserting the septum 1112 into the first housing 1112 of the central portion 1104; and 4. Assembling the insert to the section 1200 to form the injection site 1100 may include:

[0277]

[0295] In one embodiment, the parts are assembled or inserted by a method selected from the group consisting of ultrasonic sealing, vibration welding, spin welding, hot plate welding, laser welding, gluing, screwing, clipping, heat sealing, and combinations thereof.

[0278]

[0296] Alternatively, the parts may be assembled or inserted by other methods understood by one skilled in the art. In one embodiment, the parts are assembled or inserted by spin welding.

[0279]

[0297] In one embodiment, the top portion 1101 and the middle portion 1104 may be manufactured as a single piece with a breakable area 1103 between the top portion 1101 and the middle portion 1104 .

[0280]

[0298] As disclosed above, the top portion 1101, the breakable region 1103, the middle portion 1104, and the insert portion 1106 are each made of a blend of polyethylene (PE), polypropylene (PP), or a copolymer of ethylene and propylene with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA). In one embodiment, the polyolefin elastomer comprises styrene-ethylene-butylene-styrene (SEBS). In one embodiment, the polyolefin elastomer is styrene-ethylene-butylene-styrene (SEBS).

[0281]

[0299] In one embodiment, the top portion 1101, the breakable area 1103, the middle portion 1104, and the insert portion 1106 are each made from a blend of polyethylene (PE) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0282]

[0300] In one embodiment, the top portion 1101, the breakable area 1103, the middle portion 1104, and the insert portion 1106 are each made from a blend of polypropylene (PP) with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0283]

[0301] In one embodiment, the top portion 1101, the frangible region 1103, the middle portion 1104, and the insert portion 1106 are each made from a blend of an ethylene and propylene copolymer with a polyolefin elastomer and / or ethylene-vinyl acetate (EVA).

[0284]

[0302] In one embodiment, the top portion 1101, the breakable area 1103, the middle portion 1104, and the insert portion 1106 are each made from a blend of polyethylene (PE) with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0285]

[0303] In one embodiment, the top portion 1101, the breakable area 1103, the middle portion 1104, and the insert portion 1106 are each made from a blend of polypropylene (PP) with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0286]

[0304] In one embodiment, the top portion 1101, the breakable area 1103, the middle portion 1104, and the insert portion 1106 are each made from a blend of an ethylene and propylene copolymer with a polyolefin elastomer and ethylene-vinyl acetate (EVA).

[0287]

[0305] In one embodiment, the top portion 1101, the frangible area 1103, the middle portion 1104 and the insert portion 1106 are all made of the same material.

[0288]

[0306] In a preferred embodiment, the top portion 1101, the breakable area 1103, the center portion 1104, and the insert portion 1106 are all made from a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and / or ethylene-vinyl acetate (EVA). More preferably, the top portion 1101, the breakable area 1103, the center portion 1104, and the insert portion 1106 are all made from a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

[0289]

[0307] In another embodiment, the top portion 1101, the breakable area 1103, the middle portion 1104, and the insert portion 1106 are each made of different blends of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and / or ethylene-vinyl acetate (EVA). For example, the top portion 1101, the breakable area 1103, the middle portion 1104, and the insert portion 1106 are each made of different blends of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

[0290]

[0308] In one embodiment, the material of the top portion 1101 and middle portion 1104 is sufficiently rigid to allow easy breaking of the breakable tamper-evident cap as well as sufficiently ductile to prevent particle formation.

[0291]

[0309] Additionally, the inner diameter of the first housing 1109 of the central portion 1104 must also be tight enough to ensure sufficient compression against the septum 1112 .

[0292]

[0310] In one embodiment, the material of insert 1106 is soft enough to allow easy and particle-free puncture with various types and gauges of needles.

[0293]

[0311] In one embodiment, the material of the portion is selected to be sufficiently ductile to prevent particle formation when tearing the fracture zone and when puncturing with needles of various types and gauges.

[0294]

[0312] In another aspect, the present invention relates to a method for transferring fluid from a medical flexible container using the medical device / injection site.

[0295]

[0313] In one embodiment, the method comprises the following steps: connecting the medical device / infusion site with a medical flexible container such as an MCB; breaking off the top of the medical device / injection site; puncturing the septum with a syringe needle; and Transferring fluid from a pharmaceutical flexible container Includes:

[0296]

[0314] In one embodiment, the insert 1106 of the infusion site 1100 is connected to a port tube of a flexible medical container such as a monobag or MCB.

[0297]

[0315] In one embodiment, the top portion 1101 of the injection site 1100 is twisted off by breaking the breakable section 1103 .

[0298]

[0316] In one embodiment, the needle of the syringe pierces through the first opening 1108, through the septum 1112 and the second tunnel 1110. Thus, fluid within the pharmaceutical flexible container / MCB can be transferred from the pharmaceutical flexible container / MCB to the syringe.

[0299]

[0317] The medical device / injection site may have the following general advantages:

[0300] 1. The interference fit between the top 1101 and the septum 1112 is such that once the protection is removed a sterile barrier is maintained to prevent contamination of the membrane surface and to prevent microbiological entry after puncturing the membrane 1116. 2. The top 1101 and insert 1106 assembled by ultrasonic sealing can be leak-tight. 3. After removal of the protection (e.g., removal of the breakable area or lid), the outer diameter of the septum 1112 is selected to help guide the needle during insertion to avoid puncturing through the wall of the injection site 1100. 4. The injection site 1100 may be compatible with commercially available caps such as the Viaflo addition cap, thus allowing the user (e.g., nurse) to prevent further additions to the MCB if desired. 5. The injection site 1100 is compatible with an insulin needle. In one embodiment, the distance between the membrane 1116 and the top of the injection site 1100 after removing the protection from the breakable area 1103 is less than 9.5 mm. 6. The part is designed to be inserted automatically without damaging the part. 7. The insert 1106 is designed to allow a leak-free connection with the port tube of the MCB via an interference fit. 8. The breakable area 1103 acts as a tamper evident feature, allowing the user to check the integrity of the product before use. 9. The shape and materials of the parts may be selected to ensure sterility of the injection site 1100 by allowing the entire assembly to withstand gamma sterilization. 10. The protection of the breakable area or lid makes it possible to guarantee the sterility of the surface of the septum even if the septum is sterilized without an overpouch.

[0301]

[0318] Unless otherwise defined herein, all terms used in the context of the present invention should be interpreted according to the understanding of those skilled in the art.

[0302]

[0319] It should be understood that various changes and modifications to the examples described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

1. 1. A medical device for transferring fluid from a medical flexible container, the medical device comprising: The upper part, a first enclosure wall surrounding a first tunnel having a first inner diameter; a first opening having an inner diameter that gradually expands from the first inner diameter at a first end of the first opening to a second inner diameter at a second end of the first opening; an upper portion comprising: A central portion, a second opening having the second inner diameter; a second enclosure having a third inner diameter for retaining a septum; a third opening having the third inner diameter; and a central portion comprising: a breakable area between the top and the middle portion; An insertion portion, a third enclosure wall surrounding the second tunnel; an upper side of the third enclosure having a membrane separate from the septum; Insertion section and A medical device comprising:

2. The medical device of claim 1 , wherein the first surrounding wall, the second surrounding wall, and the frangible area are all made of the same material.

3. 3. The medical device of claim 2, wherein the material is selected from the group consisting of polyethylene (PE), polypropylene (PP), ethylene and propylene copolymers blended with polyolefin elastomers and / or ethylene-vinyl acetate (EVA), and combinations thereof.

4. 10. The medical device of claim 1, wherein the first surrounding wall, the second surrounding wall, and the frangible region all comprise a blend of polypropylene (PP), styrene-ethylene-butylene-styrene (SEBS), and ethylene-vinyl acetate (EVA).

5. The medical device of claim 1 , comprising a first housing that holds the septum, the first housing being a self-sealing septum.

6. 6. The medical device of claim 5, wherein the septum comprises an elastomeric material selected from the group consisting of polyisoprene, silicone, natural rubber, polychloroprene, nitrile, carboxylated acrylonitrile butadiene rubber, styrene butadiene rubber, butadiene copolymers, polyurethane, vinyl, and mixtures thereof.

7. The medical device of claim 1 , wherein the septum comprises polyisoprene.

8. 2. The medical device of claim 1, wherein the second surrounding wall of the central portion has a convex structure closer to the third opening than the first opening or the second opening, and the convex structure fits into a concave structure on the upper surface of the insertion portion.

9. The medical device of claim 1 , wherein the third inner diameter is larger than the second inner diameter.

10. 10. The medical device of claim 1, wherein the breakable area is made of a material that is sufficiently rigid to allow easy breaking of the breakable tamper-evident cap and sufficiently ductile to prevent particle formation after said breaking.

11. The medical device of claim 1 , wherein the top section, the middle section, and the insert section are molded into a single device.

12. The medical device of claim 1 , wherein the top section, the middle section, and the insert section are molded separately and assembled into a single device.

13. The medical device of claim 1 , wherein the top portion comprises a fin attached to an exterior surface of the first enclosure.

14. The medical device of claim 1 , wherein the insert comprises a flange attached to an outer surface of the third enclosure.

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