Pressure-regulating fluid transfer systems and methods

• US 10,406,072 B2
• Filed: 01/15/2016
• Issued: 09/10/2019
• Est. Priority Date: 07/19/2013
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Chhikara, Bhupinder, Lingutla, Srinath, Eads, Brandon
• Primary Examiner(s): Klein, Benjamin J
• Application Number:
  US14/997,231
• Publication Number:
  US 20160206512A1
• Time in Patent Office: 1,334 Days
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 1/22 with means for metering the amount of fluid
• CPC Class Codes: A61M 2005/1623 Details of air intake
• CPC Class Codes: A61M 2005/1787 Syringes for sequential delivery of fluids, e.g. first medicament and then flushing liquid
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2005/3132 having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
• CPC Class Codes: A61M 2005/31598 having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/3145 Filters incorporated in syringes
• CPC Class Codes: A61M 5/31513 Piston constructions to improve sealing or sliding
• CPC Class Codes: A61M 5/3298 Needles arranged in parallel

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.

Claims

1. A pressure-regulating system configured to transfer medical fluids from the pressure-regulating system to a flexible medical container, the pressure-regulating system comprising:

an adapter assembly configured to connect with a flexible medical container that has a variable volume; and

a syringe assembly configured to releasably connect with the adapter assembly and to transfer fluid to and from the flexible medical container via the adapter assembly, the syringe assembly comprising;

a housing comprising a barrel and a tube;

the barrel having a proximal portion, a distal portion, a rigid sidewall, and an inner surface;

the tube being 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 pressure-regulating system is configured to operate such that the combined total volume of the regulating reservoir and the access reservoir within the housing is variable, and the regulating reservoir is in fluid communication with an interior of the flexible medical container, when fluid is transferred between the syringe assembly and the flexible medical container.

2. The system of claim 1, 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.

3. The system of claim 1, wherein the pressure-regulating system is further configured to operate such that 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.

4. The system of claim 1, wherein the pressure-regulating system is further configured to operate such that 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.

5. The system of claim 1, wherein the pressure-regulating system is further configured to operate such that the volume of the regulating reservoir is substantially constant when fluid is transferred between the syringe assembly and the flexible medical container.

6. The system of claim 1, wherein the adapter assembly does not comprise an ambient air inlet.

7. The system of claim 1, wherein the pressure-regulating system is further configured to operate such that substantially no regulating fluid is transferred from the flexible medical container into the regulating reservoir.

8. The system of claim 1, 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 ambient.

9. The system of claim 8, wherein the proximal seal is located radially inward of the rigid sidewall of the barrel.

10. The system of claim 8, wherein the pressure-regulating system is further configured to operate such that the proximal seal moves relative to the housing when the medical fluid is introduced into the variable volume container.

11. The system of claim 1, wherein the flexible medical container comprises an IV bag.

12. A combination of the pressure-regulating system of claim 1 and the flexible medical container.