Pressure-regulating vial adaptors
First Claim
1. An adaptor configured to couple with a sealed vial, the adaptor comprising:
- a housing apparatus including a distal access aperture configured to permit introduction of fluid into the sealed vial when the adaptor is coupled to the sealed vial, wherein at least a portion of an access channel and at least a portion of a regulator channel pass through the housing apparatus;
a regulator enclosure, wherein when the adaptor is coupled with the vial the regulator enclosure is in fluid communication with the inside of the vial via the regulator channel, wherein the regulator enclosure is configured to move between;
a first orientation in which at least a portion of the regulator enclosure is at least partially folded; and
a second orientation in which at least a portion of the regulator enclosure is at least partially unfolded when fluid is introduced into the sealed vial via the access channel; and
a check valve positioned between the housing apparatus and the regulator enclosure;
wherein, when the adaptor is coupled with the vial, in response to a pressure difference between the inside and outside of the vial that exceeds a cracking pressure of the check valve, the check valve is configured to open and permit ambient air to enter the vial via the adaptor, thereby substantially equalizing the pressure inside the vial relative to the pressure outside the vial; and
wherein a rigid housing does not entirely contain the regulator enclosure in the second orientation.
3 Assignments
0 Petitions
Accused Products
Abstract
In certain embodiments, a vial adaptor comprises a housing configured to couple the adaptor with a vial, an access channel, a regulator channel, and a regulator assembly. The access channel is configured to facilitate withdrawal of fluid from the vial when the adaptor is coupled to the vial. The regulator channel is configured to facilitate a flow of a regulating fluid from the regulator assembly to compensate for changes in volume of a medical fluid in the vial. In some embodiments, the regulator assembly includes a flexible member configured to expand and contract in accordance with changes in the volume of the medical fluid in the vial. In some embodiments, the flexible member is substantially free to expand and contract. In some embodiments, the flexible member is not partly or completely located in a rigid enclosure.
390 Citations
52 Claims
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1. An adaptor configured to couple with a sealed vial, the adaptor comprising:
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a housing apparatus including a distal access aperture configured to permit introduction of fluid into the sealed vial when the adaptor is coupled to the sealed vial, wherein at least a portion of an access channel and at least a portion of a regulator channel pass through the housing apparatus; a regulator enclosure, wherein when the adaptor is coupled with the vial the regulator enclosure is in fluid communication with the inside of the vial via the regulator channel, wherein the regulator enclosure is configured to move between; a first orientation in which at least a portion of the regulator enclosure is at least partially folded; and a second orientation in which at least a portion of the regulator enclosure is at least partially unfolded when fluid is introduced into the sealed vial via the access channel; and a check valve positioned between the housing apparatus and the regulator enclosure; wherein, when the adaptor is coupled with the vial, in response to a pressure difference between the inside and outside of the vial that exceeds a cracking pressure of the check valve, the check valve is configured to open and permit ambient air to enter the vial via the adaptor, thereby substantially equalizing the pressure inside the vial relative to the pressure outside the vial; and wherein a rigid housing does not entirely contain the regulator enclosure in the second orientation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 46)
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14. A method of manufacturing a vial adaptor configured to couple with a sealed vial, the method comprising:
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providing a pressure regulating vial adaptor module comprising; a housing apparatus including a distal access aperture configured to permit introduction of fluid into the sealed vial when the adaptor is coupled to the sealed vial, wherein at least a portion of an access channel and at least a portion of a regulator channel pass through the housing apparatus; and a proximal regulator aperture in fluid communication with the regulator channel, wherein the proximal regulator aperture is configured to permit passage of regulator fluid therethrough when the vial adaptor module is coupled with the sealed vial and fluid is introduced into the vial; providing a regulator fluid module comprising; a regulator enclosure configured to move between a first orientation in which at least a portion of the regulator enclosure is at least partially folded and a second orientation in which at least a portion of the regulator enclosure is at least partially unfolded when fluid is introduced into the vial; wherein the regulator enclosure comprises a first side and a second side opposite the first side, the first side comprising a first sheet of flexible material having a periphery and the second side comprising a second sheet of flexible material having a periphery, the first and second sides being joined around the peripheries of the first and second sheets, each of the first and second sides being configured to unfold as fluid is introduced into the vial; wherein the regulator enclosure is not entirely contained within a rigid housing in the second orientation; and placing the regulator enclosure in fluid communication with the regulator channel. - View Dependent Claims (15, 16, 17)
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18. A pressure-regulating vial adaptor comprising:
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a connector unit configured to connect with a sealed vial, the connector unit comprising; a piercing member configured to pierce a septum of the sealed vial; an access channel configured to permit the introduction of fluid into the sealed vial when the connector unit is connected with the sealed vial; and a regulator channel configured to permit a fluid flow therethrough when fluid is introduced into the sealed vial; a reservoir assembly on a radial side of the connector unit, the reservoir assembly comprising; a check valve; and a reservoir configured to receive the fluid flow from the regulator channel, the reservoir comprising a first side and a second side opposite the first side, the first and second sides each configured to move when fluid is introduced into the vial, the first and second sides configured to receive fluid therebetween when fluid is introduced into the vial; wherein the reservoir is configured to move between; a first state in which at least a portion of the reservoir is at least partially unexpanded; and a second state in which at least a portion of the reservoir is at least partially expanded when fluid is introduced into the sealed vial via the access channel; and a rigid housing connected with the connector unit, the rigid housing comprising an internal space; wherein the adaptor is configured such that, when the reservoir moves from the first state to the second state, a portion of the reservoir expands out of the rigid housing, such that some of the reservoir is positioned outside of the internal space of the rigid housing; wherein, when the adaptor is coupled with the vial, in response to a pressure difference between the inside and outside of the vial that exceeds a cracking pressure of the check valve, the check valve is configured to open and permit ambient air to enter the vial via the adaptor, thereby substantially equalizing the pressure inside the vial relative to the pressure outside the vial. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 47, 48)
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29. An adaptor configured to couple with a sealed vial, the adaptor comprising:
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a housing apparatus including a distal access aperture configured to permit withdrawal of fluid from the sealed vial when the adaptor is coupled to the sealed vial, wherein at least a portion of an access channel and at least a portion of a regulator channel pass through the housing apparatus; a regulator enclosure in fluid communication with the regulator channel, the regulator enclosure comprising a first layer having multiple plies and a second layer having multiple plies, the second layer connected with the first layer, the first and second layers configured to receive regulating fluid therebetween; wherein the regulator enclosure is configured to move from an unfolded configuration to a folded configuration in response to fluid being withdrawn from the sealed vial via the access channel; and a rigid housing connected with the housing apparatus, wherein the rigid housing does not entirely contain the regulator enclosure in the unfolded configuration. - View Dependent Claims (49, 50)
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30. A vial adaptor configured to couple with a sealed vial, the vial adaptor comprising:
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a housing unit comprising an access channel that facilitates transfer of medical fluid between a needleless medical device and the sealed vial when the adaptor is coupled with the sealed vial; a regulator unit configured to expand and contract, the regulator unit comprising a flexible first side and a flexible second side opposite the first side, the first side comprising; an inner surface forming a portion of the regulator unit interior; an outer surface forming a portion of the regulator unit exterior, the outer surface of the first side being oriented towards the housing unit; and an aperture in fluid communication with the regulator unit interior; and a check valve positioned adjacent the regulator unit, wherein when the vial adaptor is coupled with the vial and when a pressure difference between the inside and outside of the vial exceeds a cracking pressure of the check valve, the check valve is configured to open and permit ambient air to enter the vial via the adaptor, thereby substantially equalizing the pressure inside the vial relative to the pressure outside the vial; wherein, when medical fluid is removed from the sealed vial via the access channel, regulating fluid flows from the regulator unit into the sealed vial via a first fluid path, thereby contracting the regulator unit; wherein, when medical fluid is introduced into the sealed vial via the access channel, regulating fluid flows from the sealed vial into the regulator unit via a second fluid path, thereby expanding the regulator unit such that at least the first and second sides of the regulator unit move relative to the housing unit; and wherein, when the regulator unit is fully expanded, substantially none of the regulator unit is contained within a rigid enclosure portion of the vial adaptor. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 51)
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40. A method of using a pressure-regulating vial adaptor, the method comprising:
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attaching the vial adaptor to a sealed vial, the vial adaptor comprising a connector unit and a bag, wherein; the connector unit comprises an access channel and a regulating channel, the access channel configured to permit medical fluid to be transferred between a medical device and the sealed vial when the adaptor is coupled with the sealed vial, the regulator channel configured to permit a flow of regulating fluid therethrough when medical fluid is transferred between the medical device and the sealed vial; and the bag comprises a first layer and a second layer opposite the first layer, the first and second layers each having multiple plies; introducing medical fluid into the sealed vial; transferring regulating fluid from the sealed vial to the bag; and expanding the bag, wherein expanding the bag comprises; moving each of the first and second layers relative to the connector unit; and moving a portion of the bag from a position inside of a rigid enclosure of the vial adaptor to a position outside of the rigid enclosure of the vial adaptor. - View Dependent Claims (41, 42, 43, 44, 45, 52)
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Specification