Device for removing fluid from blood in a patient

• US 20090234266A1
• Filed: 02/23/2009
• Published: 09/17/2009
• Est. Priority Date: 08/24/2006
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Solomon, Barry A., Fazio, Frank A., Erman, Gregory S.
• Granted Patent: US 8,241,239 B2
• Time in Patent Office: Days
• US Class Current: 604/6.90
• CPC Class Codes: A61M 1/1627 Dialyser of the inside perfusion type, i.e. blood flow inside hollow membrane fibres or tubes
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2209/088 on the body
• CPC Class Codes: B01D 2313/10 Specific supply elements
• CPC Class Codes: B01D 2313/12 Specific discharge elements
• CPC Class Codes: B01D 2313/21 Specific headers, end caps
• CPC Class Codes: B01D 61/145 Ultrafiltration
• CPC Class Codes: B01D 63/026 Wafer type modules or flat-surface type modules
• CPC Class Codes: B01D 65/08 Prevention of membrane fouling or of concentration polarisation

Abstract

An ultrafiltration device and method for the removal of excess fluid in hypervolemic patients and/or removal of toxins in the blood including for patients suffering from either renal or cardiovascular disease is disclosed. An embodiment of the device includes a housing containing multiple large bore hollow fiber membranes which are connected to the patient'"'"'s vascular system via a connecting element comprising bifurcated fluid pathway elements to physiologically channel the blood flow either to or from each hollow fiber membrane of the device, a channel to direct the fluid removed by the device to a suitable collection container or the patient'"'"'s bladder, and controls that control excessive removal of the water from the patient. Devices can be either worn extracorporeally or surgically implanted in order to allow for continuous fluid removal with ambulatory freedom.

Claims

1. An apparatus for removing fluid from a patient, comprising:

a) a first header defining a first flow path having a single inlet and multiple outlets and a means for uniformly distributing fluid flow from the single inlet to the multiple outlets;

b) a second header defining a second flow path having multiple inlets and a single outlet;

c) a filter in fluid communication with said first header and said second header;

d) a first graft for connecting the vascular system of the patient to the single inlet;

e) a second graft for connecting the single outlet to the vascular system of the patient;

f) a housing adapted to collect fluid that passes through the filter; and

g) a drain conduit connected to the housing.

2. The apparatus of claim 1, wherein said second header includes a means for uniformly distributing fluid flow from the multiple inlets to the single outlet.

3. The apparatus of claim 1, wherein the means for uniformly distributing fluid flow from the single inlet to the multiple outlets comprises one or more flow restricting neck regions located near one or more of the multiple outlets.

4. The apparatus of claim 1, wherein the means for uniformly distributing fluid flow from the multiple inlets to the single outlet comprises one or more flow restricting neck regions located near one or more of the multiple inlets.

5. The apparatus of claim 1, wherein the means for uniformly distributing fluid flow from the single inlet to the multiple outlets comprises the first flow path progressively bifurcating divergently from the single inlet to the multiple outlets.

6. The apparatus of claim 1, wherein the means for uniformly distributing fluid flow from the multiple inlets to the single outlet comprises the second flow path progressively converging from the multiple inlets to the single outlet.

7. The apparatus of claim 1, wherein said first header and said second header are substantially the same size and shape.

8. The apparatus of claim 1, wherein the drain conduit is adapted to be in fluid communication with the bladder of the patient.

9. The apparatus of claim 1, wherein said filter comprises a plurality of hollow fiber membranes.

10. The apparatus of claim 1, wherein said filter has a total membrane surface area of about 600 square centimeters (cm²) or less.

11. The apparatus of claim 9, wherein said hollow fibers are between about 1 and about 7 millimeters (mm) in diameter.

12. The apparatus of claim 9, wherein the number of hollow fiber membranes is between about 12 and about 60 hollow fibers.

13. The apparatus of claim 1, further comprising a means for controlling the amount of fluid removed by the apparatus.

14. The apparatus of claim 13, wherein said means for controlling the amount of fluid removed comprises a valve controlled by a sensor monitoring a physiological parameter of the patient.

15. The apparatus of claim 14, wherein the physiological parameter is selected from the group consisting of blood pressure, weight, lung capacity, blood pressure, blood oncotic pressure, blood osmolality, blood constituent level, blood gas levels, and combinations thereof.

16. The apparatus of claim 1, further comprising a valve adapted to restrict fluid flow through the drain conduit.

17. The apparatus of claim 16, wherein the valve is a manual valve.

18. The apparatus of claim 1, wherein the filter is substantially permeable to water and substantially impermeable to blood cells and proteins.

19. The apparatus of claim 1, wherein said first header and said second header are elongated members.

20. The apparatus of claim 19, wherein said first header, said second header and the filter are substantially coplanar.

21. The apparatus of claim 9, wherein each of the plurality of hollow fiber membranes are aligned with each of the multiple outlets on a one-to-one basis and each of the plurality of hollow fiber membranes are aligned with each of the multiple inlets on a one-to-one basis.

22. An apparatus for removing fluid from a patient, comprising:

a) a first header defining a first flow path having a first inlet and multiple outlets and one or more necks located near one or more of the multiple outlets;

b) a second header having a second outlet;

c) a filter in fluid communication with said first header and said second header;

d) a graft for connecting the vascular system of the patient to the first inlet;

e) a graft for connecting the second outlet to the vascular system of the patient;

f) a housing adapted to collect fluid that passes through the filter; and

g) a drain conduit connected to the housing.

23. The apparatus of claim 22, wherein said second header defines a second flow path having multiple inlets and one or more necks located near one or more of the multiple inlets.

24. The apparatus of claim 22, wherein the one or more necks in the first flow path are adapted to promote the uniform flow of fluid through the apparatus.

25. The apparatus of claim 22, wherein the one or more necks in the first flow path that are closer to the first inlet are more flow restrictive than the one or more necks that are farther away from the first inlet.

26. The apparatus of claim 23, wherein the one or more necks in the second flow path that are closer to the second outlet are more flow restrictive than the one or more necks that are farther away from the second outlet.

27. The apparatus of claim 22, wherein the drain conduit is adapted to be in fluid communication with the bladder of the patient.

28. The apparatus of claim 22, wherein the first flow path progressively bifurcates divergently from the first inlet to the multiple outlets.

29. The apparatus of claim 23, wherein the second flow path progressively converges from the multiple inlets to the second outlet.

30. The apparatus of claim 22, wherein said filter comprises a plurality of hollow fiber membranes.

31. The apparatus of claim 22, wherein said filter has a total membrane surface area of about 600 cm² or less.

32. The apparatus of claim 30, wherein said hollow fibers are between about 1 and about 7 mm in diameter.

33. The apparatus of claim 30, wherein the number of hollow fiber membranes is between about 12 and about 60 hollow fibers.

34. The apparatus of claim 22, further comprising a means for controlling the amount of fluid removed by the apparatus.

35. The apparatus of claim 34, wherein said means for controlling the amount of fluid removed comprises a valve controlled by a sensor and microprocessor monitoring a physiological parameter of the patient.

36. The apparatus of claim 35, wherein the physiological parameter is selected from the group consisting of blood pressure, weight, and lung capacity, blood pressure, blood oncotic pressure, blood osmoality osmolality, blood constituent level, blood gas levels, and combinations thereof.

37. The apparatus of claim 22, further comprising a valve adapted to restrict fluid flow through the drain conduit.

38. The apparatus of claim 37, wherein the valve is a manual valve.

39. The apparatus of claim 22, wherein the filter is substantially permeable to water and substantially impermeable to blood cells and proteins.

40. The apparatus of claim 22, wherein said first header, said second header and the filter are substantially coplanar.

41. The apparatus of claim 29, wherein each of the plurality of hollow fiber membranes are aligned with each of the multiple outlets on a one-to-one basis and each of the plurality of hollow fiber membranes are aligned with each of the multiple inlets on a one-to-one basis.

42. The apparatus of claim 40, wherein said first header, said second header and the housing are each less than about 10 mm in thickness.

43. An apparatus for removing fluid from a patient comprising:

a) a first header having multiple outlets;

b) a second header; and

c) a filter in fluid communication with the first header and the second header, the first header, the second header and the filter defining a flow path, the flow path including one or more neck regions near one or more of the multiple outlets.

44. The apparatus of claim 43, wherein the second header has multiple inlets, and the flow path includes one or more neck regions near one or more of the multiple inlets.

45. The apparatus of claim 43, wherein the first header has a first inlet, the filter includes multiple hollow fiber membranes, and the one or more neck regions are progressively less constricting the greater the distance between the first inlet and the multiple hollow fiber membranes.

46. The apparatus of claim 43, wherein the first header and the second header are elongated members, and the first header, the second header and the filter are substantially coplanar.

47. An implantable hemoconcentrator for removing fluid from a patient comprising:

a) a first header defining a first flow path and having a first inlet and multiple outlets, the first flow path progressively bifurcating from the first inlet to the multiple outlets;

b) a second header; and

c) a filter in fluid communication with the first header and the second header.

48. The apparatus of claim 47, wherein the second header has multiple inlets and a second outlet and defines a second flow path, the second flow path progressively converging from the multiple inlets to the second outlet.

49. An implantable hemoconcentrator for removing fluid from blood of a patient comprising:

a) a first header;

b) a second header; and

c) a filter comprising a plurality of hollow fiber membranes, the filter in fluid communication with the first header and the second header, the first header, the second header and the filter adapted to define a flow path that provides substantially uniform flow of blood through each of the hollow fiber membranes with minimal stagnation in the flow of blood.

50. The apparatus of claim 49, wherein

a) the first header and the second header are elongated members;

b) the first header, the second header and the filter are substantially coplanar; and

c) the first header, the second header and the filter are each less than about 10 mm in thickness.

51. A method of removing fluid from the body of a patient comprising:

a) surgically implanting a device, the device comprising,

i) a first header defining a first flow path having a first inlet and multiple outlets and one or more necks located near one or more of the multiple outlets,

ii) a second header defining a second flow path having multiple inlets and a second outlet,

iii) a filter in fluid communication with said first header and said second header,

iv) a first graft for connecting the vascular system of the patient to said first inlet,

v) a second graft for connecting said second outlet to the vascular system of the patient,

vi) a housing adapted to collect fluid that passes through the filter, and

vii) a drain conduit connected to the housing;

b) connecting the first graft to a first blood vessel of the patient;

c) connecting the second graft to a second blood vessel of the patient; and

d) connecting the drain conduit to the bladder of the patient.

52. The method of claim 51, wherein the device is surgically implanted in a subcutaneous location.

53. The method of claim 52, wherein the subcutaneous location is a retropubic space.

54. The method of claim 51 further comprising the step of controlling the volume of fluid removed based on one or more of a patient'"'"'s physiological parameters.

55. The method of claim 51 further comprising the step of controlling the volume of fluid removed by adjusting a fluid control valve on the device.

56. The method of claim 55, wherein the fluid control valve is adapted to be adjusted extracorporeally.

57. The method of claim 51, wherein the first blood vessel is the femoral artery and the second blood vessel is the femoral vein.

58. The method of claim 51, wherein said second header has one or more necks located near one or more of the multiple inlets.