Pressure-regulating fluid transfer systems and methods

Patent metadata

Field	Value
Publication number	US-2016206512-A1
Application number	US-201614997231-A
Country	US
Kind code	A1
Filing date	Jan 15, 2016
Priority date	Jul 19, 2013
Publication date	Jul 21, 2016
Grant date	—

Abstract

Various systems and methods for the pressure-regulated transfer of medical fluids are disclosed. The system can include an adapter assembly that connects with a medical container and with a syringe assembly. The syringe assembly can include a first reservoir and a second reservoir. In various embodiments, when the adapter assembly and the syringe assembly are coupled, the first reservoir and the container can exchange regulating fluid and the second reservoir and the container can exchange medical liquid from the medical container.

First claim

1 - 54 . (canceled)

55 . A pressure-regulating medical assembly comprising:
a syringe assembly comprising: a housing having a longitudinal axis, a proximal portion, and a distal portion; a plunger being at least partially received in the housing and movable relative to the housing; a first reservoir located in the proximal portion of the housing and configured to contain regulating fluid, at least one side of the first reservoir being bounded by a sidewall of the housing; a regulating port in fluid communication with the first reservoir via a regulating channel; a second reservoir located in the distal portion of the housing and configured to contain medical liquid; an access port in fluid communication with the second reservoir via an access channel; a distal seal fixed to a distal end of the plunger and slidably coupled with an inner surface of the housing; and wherein, when the plunger moves relative to the housing, the distal seal slides longitudinally relative to the housing and the volume of the second reservoir changes as a function of the amount of longitudinal movement of the distal seal relative to the housing; and an adapter assembly configured to couple with the syringe assembly and with a variable volume container having an interior configured to contain medical liquid; wherein, when the adapter assembly is coupled with the syringe assembly and the flexible container, the first and second reservoirs are in fluid communication with the interior of the variable volume container, and wherein the pressure-regulating medical assembly is configured to enable medical fluid to be introduced from the second reservoir into the interior of the variable volume container.

56 . The medical assembly of claim 55 , wherein, when medical fluid is introduced from the second reservoir into the interior of the variable volume container, substantially no vacuum is created in the first reservoir.

57 . The medical assembly of claim 55 , wherein, when medical fluid is introduced from the second reservoir into the interior of the variable volume container, substantially no regulating fluid is introduced into the first reservoir.

58 . The medical assembly of claim 55 , wherein the volume of first reservoir is substantially constant as medical fluid is introduced from the second reservoir into the interior of the variable volume container.

59 . The medical assembly of claim 55 , further comprising a proximal seal, the proximal seal having a first side and a second side, the first side bounding a portion of the first reservoir, the second side being in communication with the ambient.

60 . The medical assembly of claim 59 , wherein the first reservoir is located between the distal seal and the proximal seal.

61 . The medical assembly of claim 59 , wherein the proximal seal moves relative to the housing when the medical fluid is introduced into the variable volume container.

62 . The medical assembly of claim 55 , wherein the housing comprises a rigid tube

63 . The medical assembly of claim 55 , wherein the container comprises an IV bag.

64 . The medical assembly of claim 55 , wherein the first fluid reservoir does not comprise a flexible bag.

65 . A pressure-regulating system for the transfer of medical fluids, the system comprising:
an adapter assembly configured to connect with a medical vial; and a syringe assembly configured to releasably connect with the adapter assembly, the syringe assembly comprising: a barrel having a proximal portion, a distal portion, a rigid sidewall, and an inner surface; a tube coaxial with the barrel and movable relative to the barrel, the tube having a proximal end, a distal end, and an inner passage, at least the distal end received in the barrel; a distal seal that is coupled with the distal end of the tube and that slides along an inner surface of the barrel when the tube is moved relative to the barrel, wherein the distal seal does not permit fluid to pass through the distal seal from a proximal side to a distal side of the seal; a regulating reservoir bounded in part by the rigid sidewall of the housing and the distal seal, the regulating reservoir containing an amount of regulating fluid; and an access reservoir located in the distal portion of the barrel; wherein the combined total volume of the regulating reservoir and the access reservoir is adjustable when fluid is transferred between the syringe assembly and a flexible medical container.

66 . The system of claim 65 , wherein:
when the adapter assembly and the syringe assembly are coupled, the regulating reservoir is configured to deliver regulating fluid to the medical vial and the access reservoir is configured to receive liquid from the vial; and wherein, when the adapter assembly and the syringe assembly are not coupled, the regulating reservoir and the access reservoir are each substantially sealed from the ambient environment.

67 . The system of claim 65 , wherein the combined total volume of the regulating reservoir and the access reservoir decreases when fluid is transferred from the access reservoir to the flexible medical container.

68 . The system of claim 65 , wherein the combined total volume of the regulating reservoir and the access reservoir increases when fluid is transferred from the flexible medical container to the access reservoir.

69 . The system of claim 65 , wherein the volume of the regulating reservoir is substantially constants when fluid is transferred between the syringe assembly and the flexible medical container.

70 . A pressure-regulating syringe assembly configured to couple with a flexible medicinal container containing a liquid, the pressure-regulating syringe assembly comprising:
an elongate body comprising a rigid sidewall; a first fluid reservoir located inside the elongate body, the first fluid reservoir configured to contain a volume of regulating fluid, the first fluid reservoir having a sidewall that is bounded by the rigid sidewall of the elongate body; and a second fluid reservoir located inside the elongate body, the second fluid reservoir configured to provide medical liquid to the flexible medicinal container; wherein, when the syringe assembly is coupled with the flexible medicinal container in an inverted position such that an upper surface of the liquid in the flexible medicinal container is above the syringe assembly, medicinal liquid can be introduced into the flexible medicinal container from the second fluid reservoir without forming a vacuum in the first fluid reservoir.

71 . The pressure-regulating syringe assembly of claim 70 , wherein the flexible medicinal container comprises an IV bag.

72 . The pressure-regulating syringe assembly of claim 70 , wherein the first fluid reservoir does not comprise a flexible bag.

73 . A method of transferring fluid, the method comprising:
connecting an adaptor with a variable volume medical container comprising readily flexible walls, the variable volume medical container containing a diluent liquid; connecting a syringe unit with the adaptor, the syringe unit comprising a rigid tube comprising a rigid sidewall; positioning the adaptor and syringe unit below an upper surface of the diluent liquid; depressing a plunger of the syringe unit; expelling medical liquid from a medical liquid reservoir of the syringe unit; introducing the medical liquid into the liquid diluent in the variable volume medical container while maintaining substantially ambient pressure in a regulating reservoir of the sy

Assignees

• Icu Medical Inc

Inventors

• Chhikara Bhupinder
• Lingutla Srinath
• Eads Brandon

Classifications

• A61M2005/3128

  Incorporating one-way valves, e.g. pressure-relief or non-return valves · CPC title

• A61M5/3129

  Syringe barrels (A61M5/3205 and A61M5/50 take precedence) · CPC title

• A61M2005/1787

  Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid · CPC title

• A61J1/20 Primary

  Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe · CPC title

• A61M2005/1623

  Details of air intake · CPC title