Disposable components for fluid line autoconnect systems and methods

• US 9,839,775 B2
• Filed: 08/22/2014
• Issued: 12/12/2017
• Est. Priority Date: 01/23/2008
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: McGill, David W., Scarpaci, Jacob W., Dale, James D, Helmore, Simon C., Demers, Jason A.
• Primary Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US14/466,437
• Publication Number:
  US 20140364800A1
• Time in Patent Office: 1,208 Days
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/1522 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1623 Disposition or location of membranes relative to fluids
• CPC Class Codes: A61M 1/1629 with integral heat exchanger
• CPC Class Codes: A61M 1/1631 having non-tubular membranes, e.g. sheets
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 1/288 Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/121 : interface between cassette and base
• CPC Class Codes: A61M 2205/122 : using evacuated interfaces to enhance contact
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/127 : with provisions for heating or cooling
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/13 : with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/14 : Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/36 : related to heating or cooling
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/6036 : characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2209/08 : Supports for equipment
• CPC Class Codes: A61M 39/1011 : Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/105 : Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56
• CPC Class Codes: A61M 39/20 : Closure caps or plugs for connectors or open ends of tubes
• CPC Class Codes: A61M 39/28 : Clamping means for squeezing flexible tubes, e.g. roller clamps tube strippers A61M1/83
• CPC Class Codes: A61M 39/281 : Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/16809 : by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 : by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: F04B 43/0054 : particularities of the flexible members
• CPC Class Codes: F04B 43/02 : having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence
• CPC Class Codes: F04B 43/073 : the actuating fluid being controlled by at least one valve
• CPC Class Codes: F04B 43/08 : having tubular flexible members F04B43/12 takes precedence
• CPC Class Codes: F04B 43/086 : with two or more tubular flexible members in parallel F04B43/1136 takes precedence
• CPC Class Codes: F04B 53/22 : Arrangements for enabling ready assembly or disassembly
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Components for a medical infusion fluid handling system, such as an APD system, in which one or more lines (such as solution lines), spikes or other connection ports may be automatically capped and/or de-capped. This feature may provide advantages, such as a reduced likelihood of contamination since no human interaction is required to de-cap and connect the one or more lines, the spikes or the other connection ports. For example, a fluid handling cassette may include one or more caps that cover a corresponding spike and include a raised and/or recessed feature to assist in removal of the one or more caps from the cassette. A solution line cap may include a hole and a recess, a groove or other feature to engage with a spike cap and enable removal of the spike cap.

Claims

1. A disposable component system for use with a fluid line connection system of a medical infusion system, the disposable component system comprising:

a fluid handling cassette comprising;

a generally planar body with at least one pump chamber formed as a depression in a first side of the body and a plurality of flowpaths for a fluid;

a solution line spike located at a first end of the body, the solution line spike being in fluid communication with the at least one pump chamber via at least one flowpath of the plurality of flowpaths; and

a spike cap having an inner surface configured to removably cover the solution line spike, wherein an outer surface of the spike cap includes a first raised feature that extends outwardly away from a longitudinal axis of the spike cap to aid in removal of the spike cap for connection of the solution line spike to a solution line, a second raised feature that extends outwardly away from the longitudinal axis of the spike cap to directly engage a groove in an inner surface of a solution line cap covering the solution line to engage the spike cap and the solution line cap directly with each other, and a third raised feature between the first and second raised features that extends outwardly away from the longitudinal axis of the spike cap and is configured as a stop for the solution line cap when the spike cap engages the solution line cap.

2. The disposable component system of claim 1, wherein the fluid line connection system is a peritoneal dialysis system and the spike cap is removed prior to commencement of a peritoneal dialysis therapy.

3. The disposable component system of claim 1, wherein the cassette further comprises a skirt arranged around the solution line spike to receive a proximal end of the spike cap.

4. The disposable component system of claim 3, wherein there is a recess between the skirt and the solution line spike.

5. The disposable component system of claim 4, wherein the spike cap, the skirt, and the recess are arranged to aid in forming a seal between the spike cap and the skirt.

6. The disposable component system of claim 1, further comprising the solution line cap removably connected to the solution line.

7. The disposable component system of claim 6, wherein a portion of the solution line cap is a flexible material or silicone rubber.

8. The disposable component system of claim 7, wherein the groove of the solution line cap is configured to engage with the second raised feature of the spike cap after the second raised feature of the spike cap has entered the solution line cap and stretched the flexible material.

9. The disposable component system of claim 8, wherein engagement of the solution line cap with the spike cap aids in removal of the spike cap from the solution line spike.

10. The disposable component system of claim 6, wherein the groove of the solution line cap is circumferential within the inner surface of the solution line cap.

11. The disposable component system of claim 10, wherein the groove is symmetrical.

12. The disposable component system of claim 10, wherein the groove is asymmetrical.

13. The disposable component system of claim 6, wherein the groove of the solution line cap is configured to conform with the second raised feature of the spike cap.

14. The disposable component system of claim 1, wherein the first raised feature of the spike cap is a flange.

15. The disposable component system of claim 14, wherein the flange is symmetrical.

16. The disposable component system of claim 14, wherein the flange is asymmetrical.

17. The disposable component system of claim 1, wherein the first raised feature is configured for engagement with the fluid line connection system.

18. The disposable component system of claim 1, wherein a main axis of the solution line spike is in substantially a same plane as the generally planar body of the fluid handling cassette.

19. The disposable component system of claim 1, wherein the fluid handling cassette includes a plurality of solution line spikes.

20. The disposable component system of claim 19, wherein the plurality of solution line spikes includes at least three solution line spikes.

21. The disposable component system of claim 1, further comprising:

the solution line cap for removable attachment to the solution line, wherein the inner surface of the solution line cap includes the groove for direct engagement with the second raised feature of the spike cap.

22. The disposable component system of claim 21, wherein the disposable component system further comprises indicia associated with the solution line.

23. The disposable component system of claim 22, wherein the indicia are configured to interact with the medical infusion system to affect at least one function of the medical infusion system.

24. The disposable component system of claim 1, wherein the solution line spike comprises a distal tip at or near a longitudinal axis of the solution line spike, so that a lumen of the solution line spike is not centered on the longitudinal axis of the solution line spike, allowing the distal tip to be better aligned to puncture a septum or a membrane of the solution line.

25. A disposable component system for use with a fluid line connection system of a peritoneal dialysis system, the disposable component system comprising:

a spike cap having an inner surface configured to removably cover a spike of a fluid handling cassette, wherein an outer surface of the spike cap includes a first raised feature that extends outwardly away from a longitudinal axis of the spike cap to aid in removal of the spike cap from the spike for connection of the spike to a solution line prior to commencement of a peritoneal dialysis therapy, a second raised feature that extends outwardly away from the longitudinal axis of the spike cap and is configured for direct engagement with an inner recess of a solution line cap to engage the spike cap and the solution line cap directly with each other, and a third raised feature between the first and second raised features that extends outwardly away from the longitudinal axis of the spike cap and is configured as a stop for the solution line cap when the spike cap engages the solution line cap.