FILTRATION SYSTEM FOR PREPARATION OF FLUIDS FOR MEDICAL APPLICATIONS

• US 20090182263A1
• Filed: 04/09/2007
• Published: 07/16/2009
• Est. Priority Date: 04/07/2006
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: McDowell, Christopher M., Freiderichs, Goetz, Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H., Green, Brian C.
• Granted Patent: US 8,469,331 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• 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.

Claims

1. A fluid line sealing device, comprising:

a tube with a first member movable attached thereto, the first member holding the tube in a folded condition such that the tube is sealed;

the first member being movable relative to the tube to permit the fold to be released, thereby unsealing the tube.

2. The device of claim 1, further comprising a second member having an internal size and shape close to that of the tube and which can slide over the tube, the second member being slidably attached to the tube and adjacent the first member.

3. The device of claim 1, wherein the tube has a folded portion and sides on either side of the folded portion;

the first member has a portion shaped with a cylindrical interior; and

at least the tube sides fit into the cylindrical interior.

4. The device of claim 1, wherein the first member has a retaining portion that remains attached to the tube when the first member is moved relative to the tube to permit the fold to be released.

5. The device of claim 1, further comprising a second member that has an internal surface close to the size and shape of the tube and attached to slide over a portion of the tube which is distorted by the folding, such that the portion of the tube distorted by the folding is reshaped by the second member.

6. A method of unsealing a fluid line, comprising:

straightening a folded tube to unseal it; and

placing a member over a folded portion of the tube to increase the patency of a lumen of the tube.

7. The method of claim 6, further comprising holding a tube in a bent configuration so as to form a fold that seals the tube.

8. The method of claim 7, wherein the holding includes providing a removable holding member which maintains the tube in a folded state.

9. The method of claim 6, wherein the straightening includes moving a retaining member that holds a tube in a folded state.

10. The method of claim 9, wherein the retaining member defines an annular portion that surrounds portions of the tube on either side of the folded portion.

11. The method of claim 10, wherein the retaining member remains movably attached to the tube after the straightening.

13. The method of claim 6, further comprising holding a tube in a bent configuration so as to form a fold that seals the tube.

14. The method of claim 7, wherein the holding includes providing a removable holding member which maintains the tube in a folded state.

15. The method of claim 6, wherein the straightening includes moving a retaining member that holds a tube in a folded state.

16. The method of claim 9, wherein the retaining member defines an annular portion that surrounds portions of the tube on either side of the folded portion.

17. The method of claim 10, wherein the retaining member remains movably attached to the tube after the straightening.

12. A method of unsealing a fluid line, comprising:

disengaging a sealing member that holds a tube in a sealed state; and

resiliently reshaping a portion of the tube deformed by the sealing member to increase the patency of a lumen of the tube.

18. A tube-sealing device, comprising:

at least one member and a tube in engagement therewith;

the at least one member having one or more first surface and one or more second surface;

the at least one member, in a first configuration, holding the at least one first surface against the tube to hold it in a folded state, thereby sealing the tube and creating a deformation of the tube that seals it, the tube being such that a partial deformation is retained by the tube due to stress relaxation over time;

the at least one member, in a second configuration, urging the at least one second surface against the tube such that the partial deformation retained by the tube is at least partially removed.

19. A medicament fluid circuit, comprising:

a container with an interior chamber;

the container having a fluid filling port and a fluid extraction port, both connected to the interior chamber;

the filling port having two sterilizing filters, each with a membrane, the sterilizing filters being connected in series such that their membranes are separated by a distance of at least 0.5 cm.;

a first of the sterilizing filters having a sealed inlet;

the fluid extraction port being sealed.

20. The fluid circuit of claim 19, where the fluid extraction port includes a line and the fluid extraction port line has a pyrogen filter connected thereto to filter contents passing through the fluid extraction port line.

21. The fluid circuit of claim 19, wherein the filling port has a filling line with a clamp pre-attached to it.

22. A medicament fluid circuit fluid circuit, comprising:

a container with an interior chamber;

the container having a fluid filling port, a fluid extraction port, and a pre-fill port all connected to the interior chamber;

the pre-fill port having an inline ultrafilter;

the fluid extraction port and the fluid filling ports being sealed by removable seals.

23. The fluid circuit of claim 22, wherein the container is a flexible bag capable of holding at least 20 liters of fluid.

24. The fluid circuit of claim 23, wherein the fluid filling port, fluid extraction port, and pre-fill port are all pre-sealed.

25. The fluid circuit of claim 22, wherein the ultrafilter pore size is smaller than 0.1 micron.

26. A fluid circuit, comprising:

a container with an interior chamber and inlet and outlet fluid lines connected to the interior chamber;

at least one of the inlet and outlet fluid lines being connected to a flexible tube with a length of at least 10 cm. lying within the interior chamber.

27. The fluid circuit of claim 26, wherein the container has a volume of at least 10 l.

28. The fluid circuit of claim 26, wherein only one of the inlet and outlet lines has the flexible tube attached thereto and the other does not.

29. The fluid circuit of claim 26, further comprising a pre-filling port connected to the container interior chamber.

30. The fluid circuit of claim 26, further comprising a purified water inlet port connected to the container interior chamber.

31. The fluid circuit of claim 26, further comprising a header and wherein the inlet and outlet lines are connected to the header.

32. The fluid circuit of claim 31, wherein the header is connected to at least two additional ports which permit the passage of fluid into and/or out of the container interior chamber.

33. The fluid circuit of claim 31, wherein the header is connected to at least three additional ports which permit the passage of fluid into and/or out of the container interior chamber.

34. An apparatus for filling multiple containers, comprising:

a filter with an inlet port and multiple outlet ports;

the outlet ports being pre-attached, by filling connections, to containers, each of which an interior and respective ports connected to the interior;

all of the respective ports being sealed such that the container interiors are each isolated, except the filling connection to the respective outlet port.

35. A method of filling multiple containers with concentrated medicament, comprising:

providing a filter with an inlet port and multiple outlet ports;

attaching each of the outlet ports to a container which is otherwise sealed from the environment;

after the attaching, sterilizing the filter and the multiple containers.

36. The method of claim 35, further comprising filling each of the containers by passing a medicament concentrate through the filter into the containers.

37. The method of claim 36, further comprising breaking a connection between the filter and each of the containers while simultaneously sealing it.

38. A medical fluid treatment device, comprising:

a replaceable deionization filter;

a reverse osmosis filter connected between a raw water inlet and the replaceable deionization filter;

the reverse osmosis filter being characterized by a rejection fraction of less than 95% operating at a pressure of less than 100 psi.

39. The device of claim 38, wherein the replaceable deionization filter has a capacity of at least 400 liters.

40. The device of claim 38, further comprising a support for a fluid container connected to receive fluid filtered by the replaceable deionization filter.

41. The device of claim 38, further comprising a metering pump connected between the reverse osmosis filter and the deionization filter.

42. The device of claim 38, wherein the reverse osmosis filter is characterized by a rejection fraction of less than 90% with a recovery rate of at least 30%.

43. The device of claim 38, wherein the reverse osmosis filter has a capacity of 10,000 liters.

46. The device of claim 38, wherein the reverse osmosis filter is characterized by a rejection fraction of less than 90% with a recovery rate of at leat 30%.

44. A water purification device, comprising:

a pre-filter including a sediment filter and an activated carbon filter;

a reverse osmosis filter connected to receive water filtered by the pre-filter;

the reverse osmosis filter being characterized by a rejection fraction of less than 95% operating at a pressure of less than 100 psi.;

a deionization filter connected to receive water filtered by the reverse osmosis filter.

45. The device of claim 44, further comprising two inline ultrafilters connected to receive water filtered by the deionization filter.

47. A method of operating a peritoneal dialysis pump, comprising:

providing a water purification device including at least one component configured to indicate a quantity of water pumped into a container storing a quantity of fluid required for at least one peritoneal dialysis treatment;

providing a pumping mechanism capable of pumping fluid to a patient and of pumping fluid from the patient, the pumping mechanism having a measurable or controllable pump flow rate;

connecting the water purification device to the pumping mechanism to convey water through the water purification device and the pumping mechanism into the container while measuring while storing data correlating information responsive to either a commanded flow rate or an indicated flow rate of the pumping mechanism with information responsive to indications of the quantity of water pumped provided by the water purification device.

48. The method of claim 47, further comprising, performing a peritoneal dialysis treatment using the data stored data correlating information responsive to either a commanded flow rate or an indicated flow rate of the pumping mechanism with information responsive to indications of the quantity of water pumped provided by the water purification device.