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公开(公告)号：US11318069B2
公开(公告)日：2022-05-03
申请号：US16630994
申请日：2018-07-12
发明人： Yuanpang Samuel Ding , Ying-Cheng Lo , Jacob Daniel Rivett , Grant Anthony Bomgaars , Thomas Edward Dudar , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Joseph Vincent Ranalletta , Bernd Krause
摘要： A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.
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公开(公告)号：US11623773B2
公开(公告)日：2023-04-11
申请号：US17327527
申请日：2021-05-21
发明人： Grant Anthony Bomgaars , Joseph Vincent Ranalletta , Yuanpang Samuel Ding , Ying-Cheng Lo , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Thomas Edward Dudar , Bernd Krause
摘要： A method of providing a plurality of filled product bags of sterile fluid includes positioning a bag assembly onto a filling machine. The bag assembly includes a tube, a filter assembly, bladders, and stems. A stem is attached to a bladder, forms a fluid passageway, fluidly connects to the tube, and provides fluid communication into the bladders. The method includes fluidly coupling an inlet of the filter assembly to a connection line in fluid communication with a fluid source, and filling the bag assembly with a fluid. Filling the bag assembly includes passing the fluid through the filter assembly, the fluid passageway, and into the bladder. The method includes sealing the fluid passageway at a location between the tube and the bladders. The method includes cutting the stem to form a partially filled product bag having the sealed passageway. The method includes performing an integrity test on the filter assembly.
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公开(公告)号：US11547797B2
公开(公告)日：2023-01-10
申请号：US16631051
申请日：2018-07-12
发明人： Yuanpang Samuel Ding , Marc Steven Minkus , Ying-Cheng Lo , Mark Joseph Doty , Thomas Edward Dudar , Grant Anthony Bomgaars , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Bernd Krause , Joseph Vincent Ranalletta
摘要： A syringe system includes a syringe and a filtration device connected to the syringe for sterilizing and introducing fluid into the syringe. The syringe includes a syringe barrel having a proximal end defining a barrel opening, a distal end defining a delivery opening, a bore extending between the proximal end and the distal end, and a stopper disposed in the bore of the syringe barrel. The filtration device has an inlet and an outlet coupled in fluid communication with the delivery opening at the distal end of the syringe barrel. The filtration device includes a stem and a filter membrane disposed in line with the stem. The filter membrane optionally has a plurality of pores each with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm such that a pharmaceutical fluid can be introduced as a sterilized pharmaceutical fluid into the bore of the syringe barrel by passing through the filtration device.
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公开(公告)号：US20220211579A1
公开(公告)日：2022-07-07
申请号：US17701125
申请日：2022-03-22
发明人： Yuanpang Samuel Ding , Ying-Cheng Lo , Jacob Daniel Rivett , Grant Anthony Bomgaars , Thomas Edward Dudar , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Joseph Vincent Ranalletta , Bernd Krause
摘要： A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.
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公开(公告)号：US20190388611A1
公开(公告)日：2019-12-26
申请号：US16013228
申请日：2018-06-20
发明人： Dustin Christopher Cawthon , Ieng Kin Lao , Thomas Edward Dudar , Yuanpang Samuel Ding , Ying-Cheng Lo , Houzhi Luo , Michael Patrick Morrissey , Jeffrey Scott Packard
摘要： An infusion device for dispensing fluid at a predetermined flow rate includes an elastic bladder, a pressure regulator, and a flow restrictor. The elastic bladder includes a bladder volume portion and a bladder outlet, and the elastic bladder stores fluid in the bladder volume portion and dispenses fluid through the outlet at a bladder pressure. The pressure regulator is in fluid communication with the outlet of the elastic bladder. The pressure regulator includes a fluid inlet and a fluid outlet. The fluid inlet is coupled to the bladder outlet to receive fluid from the bladder. The flow restrictor is in fluid communication with the fluid outlet. The flow restrictor and the pressure regulator cooperate to discharge fluid from the flow restrictor at a predetermined flow rate.
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公开(公告)号：US11759395B2
公开(公告)日：2023-09-19
申请号：US17701125
申请日：2022-03-22
发明人： Yuanpang Samuel Ding , Ying-Cheng Lo , Jacob Daniel Rivett , Grant Anthony Bomgaars , Thomas Edward Dudar , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Joseph Vincent Ranalletta , Bernd Krause
CPC分类号： A61J1/2089 , A61J1/10 , A61J1/2048 , A61J1/2086 , A61M5/3129 , B01D69/06 , B01D69/08
摘要： A system for reconstituting and sterilizing a concentrate includes a mixing container, a filtration device, and a product bag. The a mixing container has an inlet port and outlet port in fluid communication with a mixing chamber disposed between the inlet port and the outlet port. The mixing chamber is adapted to contain a product concentrate. The filtration device has an inlet and an outlet, the inlet of the filtration device coupled to the outlet port of the mixing container. The filtration device includes a filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm. The product bag has an inlet port coupled to the outlet of the filtration device, and has a bladder defining an empty sterile chamber for receiving sterilized and reconstituted product resulting from mixing a diluent with a product concentrate in the mixing chamber to obtain a mixture then introduced through the filtration device to obtain the reconstituted and sterilized product.
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公开(公告)号：US20200146931A1
公开(公告)日：2020-05-14
申请号：US16631017
申请日：2018-07-12
发明人： Mark Joseph. Doty , Christine L. Rebbeck , Sydney Jean Cope , William Spencer Hurst , Grant Anthony Bomgaars , Yuanpang Samuel Ding , Thomas Edward Dudar , Ying-Cheng Lo , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Joseph Vincent Ranalletta , Bernd Krause
摘要： A sterile solution product bag for lyophilizing includes a bladder, a first stem having a first stem inlet end and a first stem outlet end. The first stem outlet end is fluidly connected to the bladder and the first stem inlet end is adapted to receive a liquid. A first filter is disposed in-line with the first stem and includes a first filter membrane, a first filter open end, and a first filter closed end. The first filter closed end is disposed between the first stem inlet end and the first stem outlet end and the first filter open end is disposed in proximity to the first stem inlet end. A second stem having a second stem inlet end fluidly connected to the bladder and a second stem outlet end adapted to receive a vapor. A second filter is disposed within the second stem and includes a filter membrane.
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公开(公告)号：US11974966B2
公开(公告)日：2024-05-07
申请号：US16631030
申请日：2018-07-12
发明人： David Filiberto Schuck , Karl Hans Cazzini , Yuanpang Samuel Ding , Ying-Cheng Lo , Grant Anthony Bomgaars , Thomas Edward Dudar , Mark Edward Pasmore , Bernd Krause , Michael Joseph Sadowski , Anastasios Hristakos , Joseph Vincent Ranalletta
CPC分类号： A61J1/1456 , A61J1/10 , A61J1/1475 , A61J1/2024 , A61J1/2093 , B01D63/0241
摘要： A medical product includes a bladder, a filtration device, and a sterile product concentrate. The bladder has a perimeter seal and defining a sterile chamber. The filtration device includes a stem and a filter membrane disposed in line with the stem. The stem extends through the perimeter seal and has an inlet end accessible from outside of the perimeter seal and an outlet end in fluid communication with the sterile chamber. The filter membrane can have a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm, wherein the filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The sterile product concentrate is disposed in the sterile chamber and adapted to be reconstituted by the introduction of a pharmaceutical fluid into the chamber through the filtration device.
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公开(公告)号：US11511009B2
公开(公告)日：2022-11-29
申请号：US16631067
申请日：2018-07-12
发明人： William Spencer Hurst , Steven Clarence Jepson , Grant Anthony Bomgaars , Yuanpang Samuel Ding , Thomas Edward Dudar , Ying-Cheng Lo , Bernd Krause , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Joseph Vincent Ranalletta
摘要： A product bag includes a bladder and an elongated filtration device. The bladder includes opposing first and second film layers defining a product chamber. The first and second film layers are sealed together along a perimeter seal extending along at least a portion of a perimeter of the bladder. The elongated filtration device includes a housing, a filtration membrane disposed in the housing, an inlet adapted for receiving a fluid to be filtered, and an outlet in fluid communication with the product chamber. A majority of the elongated filtration device is embedded between the first and second film layers of the perimeter seal of the bladder to provide for a compact form factor.
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公开(公告)号：US20200222281A1
公开(公告)日：2020-07-16
申请号：US16630983
申请日：2018-07-12
发明人： Yuanpang Samuel Ding , Ying-Cheng Lo , Mark Joseph Doty , David Filiberto Schuck , Karl Hans Cazzini , Grant Anthony Bomgaars , Bernd Krause , Thomas Edward Dudar , Mark Edward Pasmore , Michael Joseph Sadowski , Anastasios Hristakos , Joseph Vincent Ranalletta
摘要： A sterile product bag includes a bladder, a stem, a filter, and a vial adaptor. The bladder has a perimeter seal and defining a sterile chamber. The stem extends through the perimeter seal and has an inlet end outside of the perimeter seal and an outlet end in fluid communication with the chamber. The filter is disposed in line with the stem and has a filter membrane with a nominal pore size in a range of approximately 0.1 μm to approximately 0.5 μm. The filter membrane is shaped as a hollow fiber with a wall and pores residing in the wall of the fiber. The vial adaptor includes a sterile hollow cannula, a sheath, and a peelable closure. The cannula is in fluid communication with the chamber of the bladder. The sheath is disposed outside of the bladder and connected to the hollow cannula. The sheath includes an interior cavity into which the hollow cannula extends. The peelable closure extends across an opening of the sheath to seal the interior cavity.
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