Modular hemodialysis system

Patent metadata

Field	Value
Publication number	US-10857277-B2
Application number	US-201213586824-A
Country	US
Kind code	B2
Filing date	Aug 15, 2012
Priority date	Aug 16, 2011
Publication date	Dec 8, 2020
Grant date	Dec 8, 2020

Abstract

Apparatuses, systems, and methods for the performance of kidney replacement therapy having or using a dialyzer, control components, sorbent cartridge, and fluid reservoirs configured to be of a weight and size suitable to be worn or carried by an individual requiring treatment are disclosed. The system has a controlled compliance dialysis circuit, where a control pump controls the bi-directional movement of fluid across a dialysis membrane. A first sorbent cartridge is provided for use in a portable treatment module having activated carbon and zirconium oxide. The system also provides for the monitoring of an inlet and outlet conductivity of a sorbent cartridge containing urease to provide a facility to quantify or monitor the removal of urea by a detachable urea removal module.

First claim

The invention claimed is:

1. A system comprising:
an extracorporeal module, an attachable portable treatment module, an attachable urea removal module, and one or more controllers;
the extracorporeal module comprising
an extracorporeal circuit comprising
a dialyzer having a dialysis membrane, a blood inlet, a blood outlet, a dialysate inlet, and a dialysate outlet;
a blood pump that pumps blood from a subject through the extracorporeal circuit; and
one or more attachments for fluidly connecting to the blood inlet and the blood outlet;

the portable treatment module comprising
a first dialysis circuit comprising
a first sorbent cartridge, with the proviso that the first sorbent cartridge does not contain urease;
one or more first control pumps;
a first control reservoir;
a first dialysate pump for conveying a dialysate from the first sorbent cartridge to the dialyzer and back to the first sorb ent cartridge; and
one or more first connectors for attaching the first dialysis circuit to the dialysate inlet and the dialysate outlet of the dialyzer;

the urea removal module comprising
a second dialysis circuit comprising
a second sorbent cartridge comprising urease;
one or more second control pumps;
one or more second control reservoirs;
a second dialysate pump for conveying a dialysate from the second sorbent cartridge to the dialyzer and back to the second sorbent cartridge; and
one or more second connectors for attaching the second dialysis circuit to the dialysate inlet and the dialysate outlet of the dialyzer;

wherein, at any given time, only one of the portable treatment module and the urea removal module is attached to the dialyzer;
wherein both the portable treatment module and the urea removal module are controlled compliant;
wherein the one or more first control pumps are configured to provide selective adjustment of the volume of the first dialysis circuit by
(A) operating in an influx direction so that fluid moves from the first control reservoir to the first dialysis circuit; and
(B) operating in an efflux direction so that fluid moves from the first dialysis circuit into the first control reservoir;
wherein the one or more second control pumps are configured to provide selective adjustment of the volume of the second dialysis circuit by
(C) operating in an influx direction so that fluid moves from the one or more second control reservoirs to the second dialysis circuit; and
(D) operating in an efflux direction so that fluid moves from the second dialysis circuit into the one or more second control reservoirs;
wherein controlled compliance of the portable treatment module is achieved by actively controlling, via the one or more controllers, the influx and efflux of fluid to and from both the first dialysis circuit and the extracorporeal circuit;
wherein controlled compliance of the urea removal module is achieved by actively controlling, via the one or more controllers, the influx and efflux of fluid to and from both the second dialysis circuit and the extracorporeal circuit;
wherein when the portable treatment module is attached to the dialyzer, the volume of fluid in the first dialysis circuit, once the system is in operation, is substantially constant;
wherein when the urea removal module is attached to the dialyzer, the volume of fluid in the second dialysis circuit, once the system is in operation, is substantially constant;
wherein when either the portable treatment module or the urea removal module is attached to the dialyzer, the system provides fluid balancing without the use of scales or gravimetric methods.

2. The system of claim 1 , wherein the first sorbent cartridge consists essentially of activated carbon and zirconium oxide.

3. The system of claim 2 , wherein the volume of fluid removed from the first dialysis circuit by the one or more first control pumps is substantially the same volume of fluid transferred from the body of the subject to the portable module.

4. The system of claim 2 , with the proviso the first dialysate pump is not a pulsatile pump.

5. The system of claim 2 , wherein a void volume space for accommodating the dialysate in the first sorbent cartridge, the dialyzer, and conduits comprising the first dialysis circuit has a substantially inflexible volume.

6. The system of claim 2 , wherein the one or more controllers control operation of the one or more first control pumps to intermittently switch between an efflux direction to move fluid across the dialysis membrane from the extracorporeal circuit to the first dialysis circuit and an influx direction to move fluid across the dialysis membrane from the first dialysis circuit to the extracorporeal circuit.

7. The system of claim 2 , wherein the one or more controllers control a ratio of a rate of blood flow through the dialyzer and a rate of dialysate through the dialyzer to be from about 1:1.5 to about 3:1.

8. A modular system for ultrafiltration, comprising:
an extracorporeal circuit, an attachable portable module, an attachable urea removal module, and one or more controllers;
the extracorporeal circuit comprising
a hemofilter having a hemofiltration membrane, a blood inlet, a blood outlet, an ultrafiltrate outlet, and a second port, the second port remaining sealed during operation of the portable module;
a blood pump for pumping blood from a subject through the extracorporeal circuit; and
one or more attachments for fluidly connecting to the blood inlet and the blood outlet;

the portable module comprising
a filtrate pump for applying a negative pressure to the hemofilter to cause ultrafiltrate to pass through the ultrafiltrate outlet;
a first control reservoir; and
a first connector for attaching the portable module to the ultrafiltrate outlet of the hemofilter;

the urea removal module comprising
a dialysis circuit comprising
a sorbent cartridge comprising urease;
one or more control pumps;
one or more second control reservoirs;
a dialysate pump for conveying a dialysate from the sorbent cartridge to the hemofilter and back to the sorbent cartridge; and
one or more second connectors for attaching the dialysis circuit to the ultrafiltrate outlet and to the second port;

wherein, at any given time, only one of the portable module and the urea removal module is attached to the hemofilter;
wherein the urea removal module is controlled compliant;
wherein the one or more control pumps are configured to provide selective adjustment of the volume of the dialysis circuit by
(A) operating in an influx direction so that fluid moves from the one or more second control reservoirs to the dialysis circuit; and
(B) operating in an efflux direction so that fluid moves from the dialysis circuit into the one or more second control reservoirs;
wherein controlled compliance of the urea removal module is achieved by actively controlling, via the one or more controllers, the influx and efflux of fluid to and from both the dialysis circuit and the extracorporeal circuit;
wherein when the urea removal module is attached to the hemofilter, the volume of fluid in the dialysis circuit, once the system is in operation, is substantially constant;
wherein when the urea removal module is attached to the hemofilter, the system provides fluid balancing without the use of scales or gravimetric methods.

9. The system of claim 8 , further comprising a relative blood volume monitor to determine the relative blood volume hydration status (RBVHS) of the blood in the extracorporeal circuit, the relative blood volume monitor configured to send information to the one or more controllers to control the rate of the filtrate pump, wherein the relative blood volume monitor determines the level (C 0 ) of

Assignees

• Kelly Thomas D
• Lyu Suping
• Pudil Bryant J
• Meyer Thomas E
• Medtronic Inc

Inventors

• Kelly Thomas D
• Lyu Suping
• Pudil Bryant J
• Meyer Thomas E

Classifications

• A61M1/1607 Primary

  before use, i.e. upstream of dialyser · CPC title

• G16H20/40

  relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture · CPC title

• G16H40/63

  for local operation · CPC title

• A61M2230/207

  hematocrit · CPC title

• A61M2205/3334

  Measuring or controlling the flow rate · CPC title