Centrifugal Gradient Dialysate Dual-Chamber Hemodiafiltrator

Abstract

The present invention provides a hemodiafiltrator comprising two compartmentalized dialysate chambers coaxially arranged in tandem. A single packed bundle of hollow fibers for blood flow is enclosed coaxially along a longitudinal axis inside the dual dialysate chambers. A configuration of a tandem arrangement of the dual dialysate chambers at least comprises a first dialysate chamber for an acidic dialysate with a varying level of urea and a second compartmentalized dialysate chamber for a basic dialysate with no urea but with a level of ammonia up to a level detected in normal human blood.

Claims

1. A centrifugal gradient dialysate dual-chamber hemodiafiltrator for hemodiafiltration, comprising: a blood compartment enclosed in a compartmentalized tubular cylinder, comprising a packed bundle of hollow fibers having an open central tubular column in a doughnut configuration on a radial cross-section; wherein the open central tubular column is compartmentalized into a proximal portion and a distal portion by a coaxial cone disk radially occluding a portion of the open central tubular column; and a mid dialysate tubular cylinder of the compartmentalized tubular cylinder, comprising a first dialysate chamber axially adjoining a second dialysate chamber across an inner circumferential rim protruding from an inner tubular wall of the mid dialysate tubular cylinder; wherein there is provided a measurable longitudinal distance between the inner circumferential rim and the coaxial cone disk on a longitudinal axis of the compartmentalized tubular cylinder.

2. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the compartmentalized tubular cylinder further comprises: the coaxial cone disk radially occluding the portion of the open central tubular column; wherein the coaxial cone disk comprises an outer conical surface distally facing the distal portion of the open central tubular column; and wherein the coaxial cone disk comprises an inner conical depression proximally facing the proximal portion of the open central tubular column.

3. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: wherein the coaxial cone disk radially occludes the portion of the open central tubular column so as to allow a first dialysate to flow toward the inner conical depression of the coaxial cone disk in a proximal-to-distal direction in the proximal portion of the open central tubular column; wherein the coaxial cone disk radially occludes the portion of the open central tubular column so as to allow a second dialysate to flow toward the outer conical surface of the coaxial cone disk in a distal-to-proximal direction in the distal portion of the open central tubular column; and wherein the first dialysate flows in a coaxially opposite direction to the second dialysate.

4. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the outer conical surface distally facing toward the distal portion of the open central tubular column; wherein the outer conical surface is configured to deflect off at a plurality of obtuse angles the second dialysate axially flowing in the distal-to-proximal direction from the distal portion of the open central tubular column to the outer conical surface of the coaxial cone disk.

5. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the inner conical depression proximally facing the proximal portion of the open central tubular column; wherein the inner conical depression is configured to deflect off at a plurality of acute angles the first dialysate axially flowing in the proximal-to-distal direction from the proximal portion of the open central tubular column to the inner conical depression.

6. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the compartmentalized tubular cylinder further comprises: the first dialysate chamber, comprising a first dialysate conduit distally adjoining a proximal portion of the mid dialysate tubular cylinder; wherein the first dialysate conduit, provided in a coaxial tube-in-tube configuration, comprises a first outer conical reservoir conduit coaxially enclosing a first inner longitudinal tubular conduit; wherein the first inner longitudinal tubular conduit longitudinally enclosed by the first outer conical reservoir in the tube-in-tube configuration distally and coaxially opens to the proximal portion of the open central tubular column so as to flow the first dialysate into the proximal portion of the open central tubular column in the proximal-to-distal direction; and wherein the proximal portion of the mid dialysate tubular cylinder proximally opens to the first outer conical reservoir conduit through a plurality of proximal curvilinear fenestrations disposed thereof around an outer perimeter of an upper radial wall of the mid dialysate tubular cylinder, so as to flow the first dialysate from the proximal portion of the mid dialysate tubular cylinder through the plurality of the proximal curvilinear fenestrations in the distal-to-proximal direction to the first outer conical reservoir conduit.

7. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the compartmentalized tubular cylinder further comprises: the second dialysate chamber, comprising a second dialysate conduit proximally adjoining a distal portion of the mid dialysate tubular cylinder; wherein the second dialysate conduit, provided in a coaxial tube-in-tube configuration, comprises a second outer conical reservoir conduit coaxially enclosing a second inner longitudinal tubular conduit; wherein the second inner longitudinal tubular conduit longitudinally enclosed by the second outer conical reservoir in the tube-in-tube configuration proximally and coaxially opens to the distal portion of the open central tubular column coaxially disposed in the mid tubular dialysate tubular cylinder, so as to flow the second dialysate into the proximal portion of the open central tubular column in the proximal-to-distal direction; and wherein the distal portion of the mid dialysate tubular cylinder distally opens to the second outer conical reservoir conduit through a plurality of distal curvilinear fenestrations disposed thereof around an outer perimeter of a lower radial wall of the mid dialysate tubular cylinder, so as to flow the second dialysate from the distal portion of the mid dialysate tubular cylinder through the plurality of the distal curvilinear fenestrations in the proximal-to-distal direction to the second outer conical reservoir conduit.

8. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the mid dialysate tubular cylinder further comprises: an outer circumferential space, provided in a cylindrically tubular configuration, disposed thereof between an outer peripheral layer of the packed bundle of the hollow fibers and the inner tubular wall of the mid dialysate tubular cylinder; wherein the outer circumferential space is compartmentalized by the inner circumferential rim into a proximal portion of the outer circumferential space and a distal portion of the outer circumferential space; wherein the proximal portion of the outer circumferential space proximally opens to the first outer conical reservoir through the plurality of the proximal curvilinear fenestrations; wherein the proximal portion of the outer circumferential space is configured to transmit the first dialysate to the first outer conical reservoir conduit through the plurality of the proximal curvilinear fenestrations; wherein the distal portion of the outer circumferential space distally opens to the second outer conical reservoir through the plurality of the distal curvilinear fenestrations; and wherein the distal portion of the outer circumferential space is configured to transmit the second dialysate to the second outer reservoir conduit through the plurality of the distal curvilinear fenestrations.

9. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the mid dialysate tubular cylinder further comprises: the mid dialysate tubular cylinder coaxially comprising proximally a proximal blood chamber and distally a distal blood chamber; wherein the upper radial wall of the mid dialysate tubular cylinder covering a roof portion of the proximal blood chamber proximally adjoins a base of the first outer conical reservoir conduit; wherein the plurality of the distal curvilinear fenestrations circumferentially encircle the roof portion of the proximal blood chamber; wherein the lower radial wall of the mid dialysate tubular cylinder covering a roof portion of the distal blood chamber distally adjoins a base of the second outer conical reservoir conduit; and wherein the plurality of the distal curvilinear fenestrations circumferentially encircle the roof portion of the distal blood chamber.

10. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 9, wherein the proximal blood chamber further comprises: a proximal inner coaxial tubular cylinder coaxially disposed in the proximal blood chamber; wherein the proximal inner coaxial tubular cylinder compartmentalizes the proximal blood chamber into a proximal outer tubular columnar space outside of and a proximal inner tubular columnar space inside the proximal inner coaxial tubular cylinder; wherein the proximal outer tubular columnar space fixedly encases a proximal portion of the packed bundle of the hollow fibers; wherein the proximal inner coaxial tubular cylinder proximally adjoins the first inner longitudinal tubular conduit, and is distally inserted in a proximal portion of the open central tubular column; and wherein the proximal inner coaxial tubular cylinder is configured to distally transmit the first dialysate from the first inner longitudinal tubular conduit to the proximal portion of the open central tubular column.

11. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 9, wherein the distal blood chamber further comprises: a distal inner coaxial tubular cylinder coaxially disposed in the distal blood chamber; wherein the distal inner coaxial tubular cylinder compartmentalizes the distal blood chamber into a distal outer tubular columnar space outside of and a distal inner tubular columnar space inside the distal inner coaxial tubular cylinder; wherein the distal outer tubular columnar space fixedly encases a distal portion of the packed bundle of the hollow fibers; wherein the distal inner coaxial tubular cylinder proximally adjoins the second inner longitudinal tubular conduit, and is proximally inserted in a distal portion of the open central tubular column; and wherein the distal inner coaxial tubular cylinder is configured to proximally transmit the second dialysate from the second inner longitudinal tubular conduit to the distal portion of the open central tubular column.

12. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the packed bundle of the hollow fibers further comprises: the outer peripheral layer of the packed bundle of the hollow fibers; wherein the outer peripheral layer is separated by >1 mm of a radial distance from the inner tubular wall of the mid dialysate tubular cylinder.

13. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the packed bundle of the hollow fibers further comprises: the open central tubular column coaxially disposed in a central portion of the packed bundle of the hollow fibers along a longitudinal axis of the packed bundle of the hollow fibers; wherein the open central tubular column is supported by an inner string harness in a tubular configuration abuttingly disposed on a perimeter of the open central tubular column.

14. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 15, wherein the packed bundle of the hollow fibers further comprises: the inner string harness; wherein the coaxial cone disk is fixedly and coaxially attached to a portion of the inner string harness; and wherein the portion of the inner string attached to the coaxial cone disk is disposed distally to the inner circumferential rim on the longitudinal axis of the compartmentalized tubular cylinder.

15. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the inner circumferential rim further comprises: wherein the inner circumferential rim tightly encircles the outer peripheral layer of a portion of the packed bundle of the hollow fibers coaxially disposed inside the mid dialysate tubular cylinder, so as to partition the packed bundle of the hollow fibers into an upper half portion of and a lower half portion of the packed bundle of the hollow fibers; and wherein the inner circumferential rim is disposed proximally to the coaxial cone disk on the longitudinal axis of the compartmentalized tubular cylinder.

16. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the mid dialysate tubular cylinder further comprises: a proximal portion of the second dialysate chamber, bordered proximally by the inner circumferential rim and distally by the coaxial cone disk; wherein a longitudinal length of the proximal portion of the second dialysate chamber measures as the measurable longitudinal distance between the coaxial cone disk and the inner circumferential rim; and wherein the proximal portion of the second dialysate chamber is configured to simultaneously receive a portion of the first dialysate deflected off the inner conical depression and a portion of the second dialysate deflected off the outer conical surface.

17. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the outer conical surface of the coaxial cone disk; wherein the outer conical surface of the coaxial cone disk is configured deflect off the second dialysate so as to direct the second dialysate from the distal-to-proximal direction in the distal portion of the open central tubular column to the proximal-to-distal direction in the distal portion of the outer circumferential space of the mid dialysate tubular cylinder.

18. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the inner conical depression of the coaxial cone disk; wherein the inner conical depression of the coaxial cone disk is configured to deflect off the first dialysate so as to direct a first portion of the first dialysate from the proximal-to-distal direction in the proximal portion of the open central tubular column to the distal-to-proximal direction in the proximal portion of the outer circumferential space of the mid dialysate tubular cylinder; and wherein the inner conical depression of the coaxial cone disk is configured to deflect off the first dialysate so as to direct a second portion of the first dialysate from the proximal-to-distal direction in the proximal portion of the open central tubular column to the proximal-to-distal direction in the distal portion of the outer circumferential space of the mid dialysate tubular cylinder.

What is claimed is:

1. A centrifugal gradient dialysate dual-chamber hemodiafiltrator for hemodiafiltration, comprising: a blood compartment enclosed in a compartmentalized tubular cylinder, comprising a packed bundle of hollow fibers having an open central tubular column in a doughnut configuration on a radial cross-section; wherein the open central tubular column is compartmentalized into a proximal portion and a distal portion by a coaxial cone disk radially occluding a portion of the open central tubular column; and a mid dialysate tubular cylinder of the compartmentalized tubular cylinder, comprising a first dialysate chamber axially adjoining a second dialysate chamber across an inner circumferential rim protruding from an inner tubular wall of the mid dialysate tubular cylinder; wherein there is provided a measurable longitudinal distance between the inner circumferential rim and the coaxial cone disk on a longitudinal axis of the compartmentalized tubular cylinder.

2. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the compartmentalized tubular cylinder further comprises: the coaxial cone disk radially occluding the portion of the open central tubular column; wherein the coaxial cone disk comprises an outer conical surface distally facing the distal portion of the open central tubular column; and wherein the coaxial cone disk comprises an inner conical depression proximally facing the proximal portion of the open central tubular column.

3. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: wherein the coaxial cone disk radially occludes the portion of the open central tubular column so as to allow a first dialysate to flow toward the inner conical depression of the coaxial cone disk in a proximal-to-distal direction in the proximal portion of the open central tubular column; wherein the coaxial cone disk radially occludes the portion of the open central tubular column so as to allow a second dialysate to flow toward the outer conical surface of the coaxial cone disk in a distal-to-proximal direction in the distal portion of the open central tubular column; and wherein the first dialysate flows in a coaxially opposite direction to the second dialysate.

4. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the outer conical surface distally facing toward the distal portion of the open central tubular column; wherein the outer conical surface is configured to deflect off at a plurality of obtuse angles the second dialysate axially flowing in the distal-to-proximal direction from the distal portion of the open central tubular column to the outer conical surface of the coaxial cone disk.

5. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the inner conical depression proximally facing the proximal portion of the open central tubular column; wherein the inner conical depression is configured to deflect off at a plurality of acute angles the first dialysate axially flowing in the proximal-to-distal direction from the proximal portion of the open central tubular column to the inner conical depression.

6. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the compartmentalized tubular cylinder further comprises: the first dialysate chamber, comprising a first dialysate conduit distally adjoining a proximal portion of the mid dialysate tubular cylinder; wherein the first dialysate conduit, provided in a coaxial tube-in-tube configuration, comprises a first outer conical reservoir conduit coaxially enclosing a first inner longitudinal tubular conduit; wherein the first inner longitudinal tubular conduit longitudinally enclosed by the first outer conical reservoir in the tube-in-tube configuration distally and coaxially opens to the proximal portion of the open central tubular column so as to flow the first dialysate into the proximal portion of the open central tubular column in the proximal-to-distal direction; and wherein the proximal portion of the mid dialysate tubular cylinder proximally opens to the first outer conical reservoir conduit through a plurality of proximal curvilinear fenestrations disposed thereof around an outer perimeter of an upper radial wall of the mid dialysate tubular cylinder, so as to flow the first dialysate from the proximal portion of the mid dialysate tubular cylinder through the plurality of the proximal curvilinear fenestrations in the distal-to-proximal direction to the first outer conical reservoir conduit.

7. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the compartmentalized tubular cylinder further comprises: the second dialysate chamber, comprising a second dialysate conduit proximally adjoining a distal portion of the mid dialysate tubular cylinder; wherein the second dialysate conduit, provided in a coaxial tube-in-tube configuration, comprises a second outer conical reservoir conduit coaxially enclosing a second inner longitudinal tubular conduit; wherein the second inner longitudinal tubular conduit longitudinally enclosed by the second outer conical reservoir in the tube-in-tube configuration proximally and coaxially opens to the distal portion of the open central tubular column coaxially disposed in the mid tubular dialysate tubular cylinder, so as to flow the second dialysate into the proximal portion of the open central tubular column in the proximal-to-distal direction; and wherein the distal portion of the mid dialysate tubular cylinder distally opens to the second outer conical reservoir conduit through a plurality of distal curvilinear fenestrations disposed thereof around an outer perimeter of a lower radial wall of the mid dialysate tubular cylinder, so as to flow the second dialysate from the distal portion of the mid dialysate tubular cylinder through the plurality of the distal curvilinear fenestrations in the proximal-to-distal direction to the second outer conical reservoir conduit.

8. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the mid dialysate tubular cylinder further comprises: an outer circumferential space, provided in a cylindrically tubular configuration, disposed thereof between an outer peripheral layer of the packed bundle of the hollow fibers and the inner tubular wall of the mid dialysate tubular cylinder; wherein the outer circumferential space is compartmentalized by the inner circumferential rim into a proximal portion of the outer circumferential space and a distal portion of the outer circumferential space; wherein the proximal portion of the outer circumferential space proximally opens to the first outer conical reservoir through the plurality of the proximal curvilinear fenestrations; wherein the proximal portion of the outer circumferential space is configured to transmit the first dialysate to the first outer conical reservoir conduit through the plurality of the proximal curvilinear fenestrations; wherein the distal portion of the outer circumferential space distally opens to the second outer conical reservoir through the plurality of the distal curvilinear fenestrations; and wherein the distal portion of the outer circumferential space is configured to transmit the second dialysate to the second outer reservoir conduit through the plurality of the distal curvilinear fenestrations.

9. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the mid dialysate tubular cylinder further comprises: the mid dialysate tubular cylinder coaxially comprising proximally a proximal blood chamber and distally a distal blood chamber; wherein the upper radial wall of the mid dialysate tubular cylinder covering a roof portion of the proximal blood chamber proximally adjoins a base of the first outer conical reservoir conduit; wherein the plurality of the distal curvilinear fenestrations circumferentially encircle the roof portion of the proximal blood chamber; wherein the lower radial wall of the mid dialysate tubular cylinder covering a roof portion of the distal blood chamber distally adjoins a base of the second outer conical reservoir conduit; and wherein the plurality of the distal curvilinear fenestrations circumferentially encircle the roof portion of the distal blood chamber.

10. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 9, wherein the proximal blood chamber further comprises: a proximal inner coaxial tubular cylinder coaxially disposed in the proximal blood chamber; wherein the proximal inner coaxial tubular cylinder compartmentalizes the proximal blood chamber into a proximal outer tubular columnar space outside of and a proximal inner tubular columnar space inside the proximal inner coaxial tubular cylinder; wherein the proximal outer tubular columnar space fixedly encases a proximal portion of the packed bundle of the hollow fibers; wherein the proximal inner coaxial tubular cylinder proximally adjoins the first inner longitudinal tubular conduit, and is distally inserted in a proximal portion of the open central tubular column; and wherein the proximal inner coaxial tubular cylinder is configured to distally transmit the first dialysate from the first inner longitudinal tubular conduit to the proximal portion of the open central tubular column.

11. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 9, wherein the distal blood chamber further comprises: a distal inner coaxial tubular cylinder coaxially disposed in the distal blood chamber; wherein the distal inner coaxial tubular cylinder compartmentalizes the distal blood chamber into a distal outer tubular columnar space outside of and a distal inner tubular columnar space inside the distal inner coaxial tubular cylinder; wherein the distal outer tubular columnar space fixedly encases a distal portion of the packed bundle of the hollow fibers; wherein the distal inner coaxial tubular cylinder proximally adjoins the second inner longitudinal tubular conduit, and is proximally inserted in a distal portion of the open central tubular column; and wherein the distal inner coaxial tubular cylinder is configured to proximally transmit the second dialysate from the second inner longitudinal tubular conduit to the distal portion of the open central tubular column.

12. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the packed bundle of the hollow fibers further comprises: the outer peripheral layer of the packed bundle of the hollow fibers; wherein the outer peripheral layer is separated by >1 mm of a radial distance from the inner tubular wall of the mid dialysate tubular cylinder.

13. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the packed bundle of the hollow fibers further comprises: the open central tubular column coaxially disposed in a central portion of the packed bundle of the hollow fibers along a longitudinal axis of the packed bundle of the hollow fibers; wherein the open central tubular column is supported by an inner string harness in a tubular configuration abuttingly disposed on a perimeter of the open central tubular column.

14. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 15, wherein the packed bundle of the hollow fibers further comprises: the inner string harness; wherein the coaxial cone disk is fixedly and coaxially attached to a portion of the inner string harness; and wherein the portion of the inner string attached to the coaxial cone disk is disposed distally to the inner circumferential rim on the longitudinal axis of the compartmentalized tubular cylinder.

15. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the inner circumferential rim further comprises: wherein the inner circumferential rim tightly encircles the outer peripheral layer of a portion of the packed bundle of the hollow fibers coaxially disposed inside the mid dialysate tubular cylinder, so as to partition the packed bundle of the hollow fibers into an upper half portion of and a lower half portion of the packed bundle of the hollow fibers; and wherein the inner circumferential rim is disposed proximally to the coaxial cone disk on the longitudinal axis of the compartmentalized tubular cylinder.

16. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 1, wherein the mid dialysate tubular cylinder further comprises: a proximal portion of the second dialysate chamber, bordered proximally by the inner circumferential rim and distally by the coaxial cone disk; wherein a longitudinal length of the proximal portion of the second dialysate chamber measures as the measurable longitudinal distance between the coaxial cone disk and the inner circumferential rim; and wherein the proximal portion of the second dialysate chamber is configured to simultaneously receive a portion of the first dialysate deflected off the inner conical depression and a portion of the second dialysate deflected off the outer conical surface.

17. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the outer conical surface of the coaxial cone disk; wherein the outer conical surface of the coaxial cone disk is configured deflect off the second dialysate so as to direct the second dialysate from the distal-to-proximal direction in the distal portion of the open central tubular column to the proximal-to-distal direction in the distal portion of the outer circumferential space of the mid dialysate tubular cylinder.

18. The centrifugal gradient dialysate dual-chamber hemodiafiltrator according to claim 2, wherein the coaxial cone disk further comprises: the inner conical depression of the coaxial cone disk; wherein the inner conical depression of the coaxial cone disk is configured to deflect off the first dialysate so as to direct a first portion of the first dialysate from the proximal-to-distal direction in the proximal portion of the open central tubular column to the distal-to-proximal direction in the proximal portion of the outer circumferential space of the mid dialysate tubular cylinder; and wherein the inner conical depression of the coaxial cone disk is configured to deflect off the first dialysate so as to direct a second portion of the first dialysate from the proximal-to-distal direction in the proximal portion of the open central tubular column to the proximal-to-distal direction in the distal portion of the outer circumferential space of the mid dialysate tubular cylinder.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1 shows a schematic three-dimensional view of a centrifugal gradient dialysate dual-chamber hemodiafiltrator.

[0027] FIG. 2 represents a schematic three-dimensional exposed cut-out view of the centrifugal gradient dialysate dual-chamber hemodiafiltrator in an assembled configuration.

[0028] FIG. 3 illustrates a schematic three-dimensional exposed cut-out view of an outer shell.

[0029] FIGS. 4A-4D depict a schematic illustration of a packed bundle of hollow fibers, an inner string harness, and an outer string harness.

[0030] FIGS. 5A-5C show a schematic illustration of a coaxial cone disk of the inner string harness.

[0031] FIGS. 6A-6B shows a schematic illustration of a successive and continuous gradient of pH of the dialysates across the packed bundle of the hollow fibers of the centrifugal gradient dialysate dual-chamber hemodiafiltrator.

[0032] FIG. 7 depicts a schematic example of a flow pattern of a first dialysate in the centrifugal gradient dialysate dual-chamber hemodiafiltrator.

[0033] FIG. 8 depicts a schematic example of a flow pattern of a second dialysate in the centrifugal gradient dialysate dual-chamber hemodiafiltrator.

[0034] FIG. 9 depicts a schematic example of a flow pattern of blood in the centrifugal gradient dialysate dual-chamber hemodiafiltrator.

DETAILED DESCRIPTION OF THE DRAWINGS

[0035] As described below, the present invention provides a centrifugal gradient dialysate dual chamber hemodiafiltrator comprising a first dialysate conduit, a second dialysate conduit, and a mid tubular cylinder which is compartmentalized into a proximal blood chamber, a mid dialysate tubular cylinder, and a distal blood chamber. The mid dialysate tubular cylinder is compartmentalized by an inner circumferential rim protruding from an inner tubular wall of the mid dialysate tubular cylinder into two compartmentalized dialysate chambers arranged in tandem along the longitudinal axis of the hemodiafiltrator. A packed bundle of hollow fibers for blood flow is enclosed coaxially along a longitudinal axis inside the mid dialysate tubular cylinder. The packed bundle of the hollow fibers is provided in a doughnut configuration on a radial cross section as a cylindrical tubular structure having an open central tubular column along a longitudinal axis of the packed bundle of the hollow fibers. The open central tubular column is compartmentalized into proximal and distal portions of the open central tubular column by a coaxial cone disk occluding a portion of the open central tubular column. It is to be understood that the descriptions are solely for the purposes of illustrating the present invention, and should not be understood in any way as restrictive or limited. Embodiments of the present invention are preferably depicted with reference to FIGS. 1 to 9, however, such reference is not intended to limit the present invention in any manner. The drawings do not represent actual dimension of devices, but illustrate the principles of the present invention.

[0036] A centrifugal gradient dialysate dual chamber hemodiafiltrator shown in FIG. 1, comprises the mid tubular cylinder 1 provided in a cylindrical configuration, the first (proximal) dialysate conduit 2 in a conically tubular configuration and the second (distal) dialysate conduit 5 in the conically tubular configuration. The first dialysate conduit 2 comprises a proximal external helical tubular cylinder 3 which is a proximal part of a conical reservoir conduit and a proximal portion 4 of a first inner longitudinal tubular conduit coaxially enclosed in the conical reservoir conduit. The second dialysate conduit 5 comprises a distal external helical tubular cylinder 6 which is a proximal part of a conical reservoir conduit and a proximal portion 7 of a second inner longitudinal tubular conduit coaxially enclosed in the conical reservoir conduit. A blood intake tube 8 opens to a proximal blood chamber hidden inside a proximal portion of the mid tubular cylinder 1, and a blood output tube 9 opens to a distal blood chamber hidden inside a distal portion of the mid tubular cylinder 1.

[0037] FIG. 2 represents a schematic three-dimensional exposed cut-out view of the centrifugal gradient dialysate dual chamber hemodiafiltrator in an assembled configuration. The mid tubular cylinder 1 of the centrifugal gradient dialysate dual chamber hemodiafiltrator comprises a proximal blood chamber 12 and a distal blood chamber 25. The proximal blood chamber 12, provided in a doughnut configuration on a radial cross section, is concentrically divided into a proximal outer tubular columnar space 13 and an inner tubular columnar space by a proximal inner coaxial tubular cylinder 11 of the proximal blood chamber 12. The distal blood chamber 25, similarly provided as in the doughnut configuration on the radial cross section, is concentrically divided into a distal outer tubular columnar space 26 and a distal inner tubular columnar space 24. The proximal outer tubular columnar space 13 fixedly encircles a proximal part of the packed bundle of the hollow fibers 20, and the distal outer tubular columnar space 26 fixedly encircles a distal part of the packed bundle of the hollow fibers 20. The blood intake tube 8 radially opens to the proximal blood chamber 12, and the blood output tube 9 radially opens to the distal blood chamber 25 in an opposite side to the blood intake tube 8, so as to establish a diagonal blood flow through the packed bundle of the hollow fibers 20. The proximal inner coaxial tubular cylinder 11 of the proximal blood chamber 12 proximally adjoins the first inner longitudinal tubular conduit 10, and is distally inserted in a proximal part of an open central tubular column 21 of a packed bundle of hollow fibers 20 in a leakproof way. The distal inner coaxial tubular cylinder 24 of the distal blood chamber 25 distally adjoins the second inner longitudinal tubular conduit 23, and is proximally inserted in a distal part of an open central tubular column 21 of the packed bundle of the hollow fibers 20 in the leakproof way. The inner coaxial tubular cylinders 11 and 24 are provided a a conduit for dialysate.

[0038] The first dialysate conduit 2 shown in FIG. 2 comprises a first conical reservoir conduit 15 proximally opening to the proximal external helical tubular cylinder 3 and the first inner longitudinal tubular conduit 4 coaxially placed in the first conical reservoir conduit 15. At an adjoined part between the first dialysate conduit 2 and a proximal portion of a mid dialysate tubular cylinder 16, there is provided an upper radial wall of the mid dialysate tubular cylinder compartmentalizing the first dialysate conduit 2 from the proximal portion of the mid dialysate tubular cylinder 16. The upper radial wall serves as a roof of the proximal blood chamber 12. The upper radial wall comprises a plurality of proximal curvilinear fenestrations disposed thereof around an outer perimeter of said upper radial wall. The first conical reservoir conduit 15 communicates with a first outer circumferential space 17 of the mid dialysate tubular cylinder 16 of the mid tubular cylinder 1 through the plurality of the proximal curvilinear fenestrations 14. An inner circumferential rim 18 of the mid dialysate tubular cylinder 16 divides an outer circumferential space of the mid dialysate tubular cylinder 16 into the first outer circumferential space 17 and a second outer circumferential space 19. The second dialysate conduit 5 comprises a second conical reservoir conduit 28 distally opening to the distal external helical tubular cylinder 6 and the second inner longitudinal tubular conduit 7 coaxially placed in the second conical reservoir conduit 28. At an adjoined part between a proximal portion of the second dialysate conduit 5 and a distal portion of the mid dialysate tubular cylinder 16, there is provided a lower radial wall of the mid dialysate tubular cylinder 16 compartmentalizing the proximal portion of the second dialysate conduit 5 from the distal portion of the mid dialysate tubular cylinder 16. The lower radial wall serves as a roof of the distal blood chamber 25. The lower radial wall comprises a plurality of distal curvilinear fenestrations disposed thereof around an outer perimeter of said distal radial wall. The second conical reservoir conduit 28 communicates with the second outer circumferential space 19 of a mid dialysate tubular cylinder 16 of the mid tubular cylinder 1 through the plurality of the distal curvilinear fenestrations 27. The first inner longitudinal tubular conduit 10 protrudes as the proximal portion 4 from the proximal external helical tubular cylinder 3, and distally adjoins the proximal inner coaxial tubular cylinder 11 of the proximal blood chamber 12. The second inner longitudinal tubular conduit 23 protrudes as the distal portion 7 from the distal external helical tubular cylinder 6, and proximally adjoins the distal inner tubular columnar space 24 of the distal blood chamber 25. A coaxial cone disk 22 is occlusively placed in a mid-to-distal point of the open central tubular column 21, so as to compartmentalize the open central tubular conduit 21 into proximal and distal open central tubular conduits and to change a direction of an incoming dialysate flow through the open central tubular column 21 to a reverse direction of an outgoing dialysate flow across the packed bundle of the hollow fibers 20 through the outer circumferential spaces 17 and 19.

[0039] Shown in FIG. 2, the first and second outer circumferential spaces 17 and 19 are provided between an outer peripheral layer of the packed bundle of the hollow fibers 20 and an inner tubular wall of the mid dialysate tubular cylinder 16, compartmentalized by the inner circumferential rim 18. The first and second outer circumferential spaces 17 and 19 are configured to serve as reservoir of the dialysate. A dimension of each outer circumferential space is determined by a radial length (height) of the inner circumferential rim 18. The radial length is not less than 0.5 mm so as to provide each outer circumferential space a measurable dimension between the outer peripheral layer of the packed bundle of the hollow fibers 20 and the inner tubular wall of each compartmentalized dialysate chamber. An innermost part of the inner circumferential rim 18 is configured to come into tight contact with the outer peripheral layer of the packed bundle of the hollow fibers 20, in order to separate each outer circumferential space of the compartmentalized dialysate chamber from each other. In this configuration, a dialysate in each outer circumferential space does not get mixed with the other dialysate in the other circumferential space across the inner circumferential rim 18, except that the dialysates can diffuse through interfibrillar spaces in between individual hollow fibers of the packed bundle of the hollow fibers 20.

[0040] FIG. 3 illustrates a schematic three-dimensional exposed cut-out view of an outer casing of the centrifugal gradient dialysate dual chamber hemodiafiltrator without the packed bundle of the hollow fibers. The blood intake tube 8 adjoins and opens to a cylindrical tubular space 29 of the proximal outer tubular columnar space 13, of the proximal blood chamber 12. The blood output tube 4 adjoins and opens to a cylindrical tubular space 31, bordered by the distal outer tubular columnar space 26 of the distal blood chamber 25. The mid dialysate tubular cylinder 16 of the mid tubular cylinder 1 is divided by the inner circumferential rim 18 into two compartmentalized dialysate chambers. The first dialysate conduit 2 comprises the first conical reservoir conduit 15 proximally opening to the proximal external helical tubular cylinder 3 and the proximal portion 4 of the first inner longitudinal tubular conduit 10 coaxially placed in the first conical reservoir conduit 15 in a coaxial tube-in-tube configuration. The first conical reservoir conduit 15 communicates with the first outer circumferential space 17 through the plurality of the proximal curvilinear fenestrations 14 and 30. The first inner longitudinal tubular conduit 10 protrudes as the proximal portion 4 from the proximal external helical tubular cylinder 3, and distally adjoins the proximal inner coaxial tubular cylinder 11 of the proximal blood chamber 12. The second dialysate conduit 5 comprises the second conical reservoir conduit 28 distally opening to the distal external helical tubular cylinder 6 and the second inner longitudinal tubular conduit 7 coaxially placed in the second conical reservoir conduit 28 in the coaxial tube-in-tube configuration. The second conical reservoir conduit 28 communicates with the second outer circumferential space 19 through the plurality of the distal curvilinear fenestrations 27 and 32. The second inner longitudinal tubular conduit 23 protrudes as the distal portion 7 from the distal external helical tubular cylinder 6, and proximally adjoins the distal tubular column 24 of the distal blood chamber 25.

[0041] FIGS. 4A-4D show the packed bundle of hollow fibers 20 comprising the individual hollow fibers 33 concentrically stacked up from around a first set of resiliently stiff inner string harness 34 abuttingly disposed on a perimeter 36 of the open central tubular column 21 shown in FIG. 2, thus forming the packed bundle of hollow fibers 20 as a cylindrical tube in a doughnut configuration. The first set of the resiliently stiff inner string harness 34 comprises a plurality of circular strings 37 and a plurality of longitudinal strings 38. The plurality of the longitudinal strings 38 fixedly adjoin the plurality of the circular strings 37, so as to impart a structural strength. The first set of the resiliently stiff inner string harness 34 in a tubular configuration provides said open central tubular column 21 with a structural strength so as to avoid inward collapse of the open central tubular column 21. The first set of resiliently stiff inner string harness 34 comprises the coaxial cone disk 22 which is fixedly and coaxially attached to a portion of the plurality of longitudinal strings 38 and to a single string of the circular string 37. The coaxial cone disk 22 occludes completely the portion of the first set of the resiliently stiff inner string harness 34, so as to compartmentalize the open central tubular column 21 into proximal and distal compartmentalized open central tubular columns. A second set of elastomeric outer string harness 35 in a tubular configuration is provided on an outer peripheral layer of the packed bundle of the hollow fibers 20 to securely tie up said packed bundle of the hollow fibers. The second set of the elastomeric outer string harness 35 comprises a mid circular string 39, a proximal circular string 41 and a distal circular string 40, which are fixedly attached to a plurality of a longitudinal strings 42. The mid circular string 39 is configured to tightly encircle the outer peripheral layer of the packed bundle of the hollow fibers 20, whereas the proximal circular string 41 and the distal circular string 40 are configured to be slightly larger in diameter than a diameter of the mid circular string 39. The larger diameter of the proximal circular string 41 and the distal circular string 40 is configured to provide the packed bundle of the hollow fibers 20 with a room to radially distend upon a centrifugal flow of a dialysate from the open central tubular column 21 to the outer peripheral layer of the packed bundle of the hollow fibers 20.

[0042] FIG. 5A show a schematic illustration of the coaxial cone disk 22 in a pointed cone configuration comprising a tip 43 and an outer conical surface 45 pointing toward the distal portion of the open central tubular column shown in FIG. 4B, and a base 44 facing the proximal portion of the open central tubular column shown in FIG. 4B. Shown in FIG. 5B, an inner surface 46 of the coaxial cone disk 22 facing the proximal portion of the open central tubular column provides the coaxial cone disk 22 with a conical depression. FIG. 5C shows a two-dimensional profile view of the coaxial cone disk 22 having the tip 43 of the outer conical surface 45, the base 44 and the inner surface 46 in the configuration of the conical depression.

[0043] FIG. 6A depicts a schematic presentation of a dialysate flow across the mid dialysate tubular cylinder 16. The coaxial cone disk 22 is disposed in a proximal part of the distal (second) open central tubular column, whereas the inner circumferential rim 18 is disposed away from the coaxial cone disk on a longitudinal axis of the mid dialysate tubular cylinder 16, close to the proximal portion of the packed bundle of the hollow fibers 20. An incoming acidic dialysate 47 into the proximal portion of the open central tubular column 21 heading distally is deflected off the inner surface 46 of the coaxial cone disk 22 at a plurality of acute angles, centrifugally sending a first group of dialysate flow 49 through the packed bundle of the hollow fibers 20 into the first outer circumferential space 17 and a second group of dialysate flow 48 through the packed bundle of the hollow fibers 20 into a proximal portion of the second outer circumferential space 19 disposed distal to the inner circumferential rim 18. An incoming basic (pH) dialysate 50 into the distal portion of the open central tubular column 21 heading proximally is deflected off the outer conical surface 45 of the coaxial cone disk 22 at a plurality of obtuse angles, centrifugally sending a third group of dialysate flow 51 through the packed bundle of the hollow fibers 20 into a distal portion of the second outer circumferential space 19 and a fourth group of dialysate flow 52 through the packed bundle of the hollow fibers 20 into the proximal portion of the second outer circumferential space 19 disposed distal to the inner circumferential rim 18.

[0044] Shown in FIG. 6A, the first compartmentalized dialysate chamber 53 receives only the incoming acidic dialysate 47, whereas the second compartmentalized dialysate chamber has two regions: the proximal portion 54 and the distal portion 55. The proximal portion 54 of the second compartmentalized dialysate chamber is defined between the base 44 shown in FIG. 5A of the coaxial cone disk 22 and a distal border of the inner circumferential rim 18. The proximal portion 54 receives a mixture of the incoming acidic dialysate 48 and the incoming basic (pH) dialysate 52, and the distal portion 55 only receives the incoming basic dialysate 51. A pH of the mixture of the dialysate in the proximal portion 54 is in between a pH of the incoming acidic dialysate 48 and a pH of the incoming basic (pH) dialysate 52. Thus, a portion of the packed bundle of the hollow fibers disposed between the base 44 shown in FIG. 5A of the coaxial cone disk 22 and the distal border of the inner circumferential rim 18 enclosed in this three-dimensional volume of the proximal portion 54 of the second compartmentalized dialysate chamber is defined as a transitional region of the current invention. Shown in FIG. 6B, a pH of the incoming acidic dialysate 47 is indicated as 56, and a pH of the incoming basic (pH) dialysate 50 is indicated as 58. Between these two different dialysates, the transitional region serves to produce a mixture of the dialysates having a continuous gradient in pH 57. Similarly, a continuous gradient in ammonia between dialysates is expected in the transitional region (not shown).

[0045] FIG. 7 shows a schematic illustration of a first dialysate flow 59 through the first dialysate conduit distally coming through the proximal portion 4 of the first inner longitudinal tubular conduit 10 of the first dialysate conduit 2 into the proximal portion of the open central tubular column 21. A first part of the dialysate flow 59 is deflected off the conical depression shown in FIG. 5C of the coaxial cone disk 22, changes direction and proximally goes through the proximal portion of the packed bundle of the hollow fibers 20, and then into the first outer circumferential space 17 as a dialysate flow of 60. In fluid dynamics, the dialysate flow 59 having a first dynamic pressure comes to a halt in the distal direction of the dialysate flow 59 and convert to a rotational flow before the dialysate flow 60 having a second dynamic pressure starts to flow in an opposite direction to the distal direction of the dialysate flow 59. An energy of the first dynamic pressure is dissipated as a centrifugal flow of the dialysate across a portion of the packed bundle of the hollow fibers having a defined amount of resistance to the dialysate flow at a time the dialysate flow 59 halts flowing and converts into the rotational flow. To make the dialysate flow 60 move at a same volume per speed but in the opposite direction as that of the dialysate flow 59, an external force needs to be applied to the dialysate flow 60 for the dialysate flow 60 to be pulled in the opposite direction at the same volume per speed. This configuration of a reversal of a flow direction of dialysate across a packed bundle of hollow fibers is to maximize efficiency of centrifugal hemodiafiltration of the dialysate. The dialysate flow 60 then goes through the curvilinear fenestrations 14 as a dialysate flow 61, into the first conical reservoir conduit 15 as a dialysate flow 62, and then out through the proximal external helical tubular cylinder 3 as a dialysate flow 63. The first conical reservoir conduit 15 is provided in a cone configuration, and has a larger volume of space than a volume of space per unit of a longitudinal length in the first compartmentalized dialysate chamber 53 illustrated in FIG. 6A. This configuration is to maintain a higher momentum of the dialysate flow 62 in the first conical reservoir conduit 15 than a momentum of the dialysate flows 60 and 61, so as to reduce variations of the dynamic pressure of the dialysate flows 60 and 61. A second part of the dialysate flow 59 is deflected off the conical depression shown in FIG. 5C of the coaxial cone disk 22, becomes a dialysate flow 64 distally flowing through the packed bundle of the hollow fibers 20, is deflected off a second time at the inner circumferential rim 18, and then becomes a dialysate flow 65 into the proximal portion of the second outer circumferential space 19. The dialysate flow 65 in the second outer circumferential space 19 goes through the curvilinear fenestrations 27 as a dialysate flow 66 into the second conical reservoir conduit 28 of the second dialysate conduit 5. Afterwards, it distally drains out of the distal external helical tubular cylinder 6 as a dialysate flow 67.

[0046] FIG. 8 shows a schematic illustration of a second dialysate flow 68 through the second dialysate conduit proximally coming through the second inner longitudinal tubular conduit 23 of the second dialysate conduit 5 into the distal portion of the open central tubular column 21 toward the coaxial cone disk 22. The second dialysate flow 68 is deflected off at the outer conical surface 45 shown in FIG. 5A of the coaxial cone disk 22, changes direction and distally goes through the distal portion of the packed bundle of the hollow fibers 20, and then into the second outer circumferential space 19 as a dialysate flow of 69. Similar to the dialysate flow 59 converting to the dialysate flow 60 in the first dialysate conduit, the dialysate flow 68 having a first dynamic pressure comes to a halt in the proximal direction of the dialysate flow 68 and convert to a rotational flow before the dialysate flow 69 having a second dynamic pressure starts to flow in an opposite direction to the proximal direction of the dialysate flow 68. An energy of the first dynamic pressure is dissipated as a centrifugal flow of the dialysate across a portion of the packed bundle of the hollow fibers having a defined amount of resistance to the dialysate flow at a time the dialysate flow 68 halts flowing and converts into the rotational flow. To make the dialysate flow 69 move at a same volume per speed but in the opposite direction as that of the dialysate flow 68, an external force needs to be applied to the dialysate flow 69 for the dialysate flow 69 to be pulled in the opposite direction at the same volume per speed. The dialysate flow 69 in the second outer circumferential space 19 goes through the curvilinear fenestrations 27 as a dialysate flow 70, drains into the second conical reservoir conduit 28 of the second dialysate conduit 5 as a dialysate flow 71, and then goes out of the second conical reservoir conduit 28 through the distal external helical tubular cylinder 6 as a dialysate flow 72. Similar to the first conical reservoir conduit 15, the second conical reservoir conduit 28 is provided in a conically tubular configuration, and has a larger volume of space than a volume of space per unit of a longitudinal length in the second compartmentalized dialysate chamber 54+55 illustrated in FIG. 6A. This configuration is to maintain a higher momentum of the dialysate flow 71 in the second conical reservoir conduit 28 than a momentum of the dialysate flows 69 and 70, so as to reduce variations of the dynamic pressure of the dialysate flows 69 and 70.

[0047] FIG. 9 shows a schematic illustration of a blood flow 73 going through the blood intake tube 8 into the proximal blood chamber 12. The blood flow 73 becomes a blood flow 74 which coaxially goes through the packed bundle of the hollow fibers 20 into the distal blood chamber 25, then goes through the blood output tube 9 as a blood flow 75. The blood flow 74 in the proximal portion of the packed bundle of the hollow fibers is countercurrent to the dialysate flow 60 shown in FIG. 7, but concurrent with the dialysate flow 69 shown in FIG. 8.

[0048] It is to be understood that the aforementioned description of the centrifugal gradient dialysate dual chamber hemodiafiltrator is simple illustrative embodiments of the principles of the present invention. Various modifications and variations of the description of the present invention are expected to occur to those skilled in the art without departing from the spirit and scope of the present invention. Therefore the present invention is to be defined not by the aforementioned description but instead by the spirit and scope of the following claims.