Filtration system for preparation of fluids for medical applications

• US 9,636,444 B2
• Filed: 04/11/2013
• Issued: 05/02/2017
• Est. Priority Date: 04/07/2006
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Burbank, Jeffrey H., Brugger, James M.
• Primary Examiner(s): Zalasky, Katherine
• Assistant Examiner(s): Lebron, Benjamin
• Application Number:
  US13/861,172
• Publication Number:
  US 20130228505A1
• Time in Patent Office: 1,482 Days
• CPC Class Codes: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/2003 Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
• 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 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/167 Flexible packaging for solid concentrates
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1674 using UV radiation sources for sterilising the dialysate
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 2205/273 preventing reuse, e.g. of disposables
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/288 by bending or twisting the tube
• CPC Class Codes: B01D 61/14 Ultrafiltration; Microfiltration
• CPC Class Codes: B01D 61/145 Ultrafiltration
• CPC Class Codes: B01D 61/146 comprising multiple ultrafiltration steps
• CPC Class Codes: B01D 63/00 : Apparatus in general for separation processes using semi-permeable membranes
• CPC Class Codes: B01L 2200/026 : Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2200/0605 : Metering of fluids
• CPC Class Codes: B01L 2200/0689 : Sealing
• CPC Class Codes: B01L 2300/0681 : Filter
• CPC Class Codes: B01L 2300/0864 : comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 3/502 : with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B65B 3/28 : by weighing
• CPC Class Codes: B65B 3/30 : by volumetric measurement
• CPC Class Codes: B65B 55/04 : Sterilising wrappers or receptacles prior to, or during, packaging sterilising bottles B67C7/00
• CPC Class Codes: C02F 1/444 : by ultrafiltration or microfiltration
• CPC Class Codes: C02F 2103/026 : Treating water for medical or cosmetic purposes
• CPC Class Codes: F16K 7/068 : by bending the hose
• CPC Class Codes: F16L 55/00 : Devices or appurtenances for use in, or in connection with, pipes or pipe systems the preceding groups and groups F16L57/00, F16L59/00 take precedence; repairing or joining pipes on or under water F16L1/26; nozzles B05B; cleaning of pipes B08B9/02; arrangements of draining devices for water main or service pipe systems E03B7/08; devices for preventing bursting of water pipes by freezing E03B7/10; draining devices for hydrants E03B9/14; for domestic plumbing installations E03C1/00; steam traps for draining of liquids from enclosures containing gases or vapours F16T; arrangements for sealing leaky tubes or conduits of heat-exchangers F28F11/00
• CPC Class Codes: F16L 55/07 : Arrangement or mounting of devices, e.g. valves, for venting or aerating or draining apparatus for draining F16T
• CPC Class Codes: Y10T 137/8593 : Systems

Abstract

Systems, methods, and devices for preparation of purified water and medicaments for various uses including blood treatment are described. Methods, devices, and systems for creating multiple-treatment batches are described. For example, a medicament fluid circuit can include a container with an interior chamber. The container can have a fluid filling port and a fluid extraction port. Both ports can be connected to the interior chamber. The filling port can have two sterilizing filters, each of which has a membrane. The sterilizing filters can be connected in series the membranes are separated by a distance of at least 0.5 cm. A first of the sterilizing filters can have a sealed inlet. The fluid extraction port can be sealed.

Claims

1. A fluid circuit, comprising:

a sterile medical liquid supply containing a sterile medical liquid and having a pump configured to convey the sterile medical liquid at a predefined flow rate;

a sterile medical liquid container made of a flexible film with

an interior chamber, and

an inlet connected to receive the sterile medical liquid from the sterile medical liquid supply at said predefined flow rate;

an inlet liquid line directly connected to the sterile medical liquid supply receiving the sterile medical liquid conveyed by the pump; and

an outlet liquid line connected to the interior chamber;

at least the inlet liquid line being further connected to a flexible tube extending into the interior chamber, wherein

the flexible tube has a fixed end and a free end separated by a predefined length, and

the flexible tube connected to the inlet liquid line is caused to whip around inside the interior chamber by the sterile medical liquid flowing through the flexible tube at the predefined flow rate.

2. The fluid circuit of claim 1, wherein the sterile medical liquid container has a volume of at least 10 liters.

3. The fluid circuit of claim 1, wherein only the inlet liquid line has the flexible tube attached thereto and the outlet liquid line does not.

4. The fluid circuit of claim 1, further comprising a pre-filling port connected to the interior chamber of the sterile medical liquid container.

5. The fluid circuit of claim 1, further comprising a purified water inlet port connected to the interior chamber of the sterile medical liquid container.

6. The fluid circuit of claim 1, further comprising a header and wherein the inlet and outlet liquid lines are connected to the header.

7. The fluid circuit of claim 6, wherein the header is connected to at least two additional ports which permit passage of liquid into and/or out of the interior chamber of the sterile medical liquid container.

8. The fluid circuit of claim 6, wherein the header is connected to at least three additional ports which permit passage of liquid into and/or out of the interior chamber of the sterile medical liquid container.

9. The fluid circuit of claim 1, wherein the predefined length of the flexible tube is sufficient to allow it to dangle and thereby permit it to whip around the interior chamber of the sterile medical liquid container thereby stirring liquids when liquid flows therethrough.

10. The fluid circuit according to claim 3, wherein

the inlet is connected to the flexible tube and conveys the sterile medical liquid into the fixed end of the flexible tube, and

the sterile medical liquid flowing out of the free end of the flexible tube whips the flexible tube inside the interior chamber.

11. The fluid circuit according to claim 1, further comprising:

a removable clamp attached to the inlet liquid line preventing flow through the inlet liquid line, the removable clamp being configured to at least partially slide off the inlet liquid line to open flow through the inlet liquid line.

12. The fluid circuit according to claim 11, wherein the removable clamp has a hollow cylindrical body surrounding a bend in the inlet liquid line.

13. The fluid circuit according to claim 1, wherein the flexible tube extending into the interior chamber has a length of at least 10 cm.