Modular hemodialysis system

• US 10,857,277 B2
• Filed: 08/15/2012
• Issued: 12/08/2020
• Est. Priority Date: 08/16/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kelly, Thomas D., Lyu, SuPing, Pudil, Bryant J., Meyer, Thomas E.
• Primary Examiner(s): Menon, Krishnan S
• Assistant Examiner(s): Gordon, Brad
• Application Number:
  US13/586,824
• Publication Number:
  US 20130213890A1
• Time in Patent Office: 3,037 Days
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 PH measuring means
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation

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.

Claims

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 (C₀) of one or more solutes in the blood at a first time and determines the level (C_t) of the one or more solutes in the blood at a second time later than the first time, and the relative blood volume hydration status is calculated by the formula RBVHS=C₀/C_t.

10. The system of claim 8, with the proviso that the attachable portable module does not have a sorbent for absorbing a waste species.

11. A method comprising:

attaching the vasculature of a patient to an extracorporeal circuit having a first end that draws blood from the patient, a second end that returns blood to the patient, and a dialyzer having a single blood inlet, a single blood outlet, a single dialysate inlet, a single dialysate outlet, and a dialysis membrane;

attaching the dialysate inlet and dialysate outlet of the dialyzer to a controlled compliant portable module, the portable module comprising a first sorbent cartridge having activated carbon therein, the portable module further comprising a first dialysis circuit and one or more first connectors for attaching the first dialysis circuit to the dialysate inlet and dialysate outlet of the dialyzer;

wherein the first dialysis circuit comprises one or more first control pumps and a first control reservoir, the one or more first control pumps configured to be controlled by one or more controllers;

conveying blood from the patient through the extracorporeal circuit and the dialyzer and returning blood to the patient;

conveying dialysate through the first dialysis circuit such that the dialysate moves from the first sorbent cartridge to the dialyzer and back to the first sorbent cartridge wherein the blood and the dialysate are in fluid communication through the dialysis membrane and one or more waste species move from the blood to the dialysate;

removing the one or more waste species from the blood of the patient for a first period of time wherein the one or more waste species are absorbed by the first sorbent cartridge;

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 controlled compliance of the portable module is achieved by actively controlling, via one or more controllers, the influx and efflux of fluid to and from both the first dialysis circuit and the extracorporeal circuit, without the use of scales or gravimetric methods;

disconnecting the dialysate inlet and dialysate outlet from the portable module;

attaching the dialysate inlet and dialysate outlet to a controlled compliant urea removal module, the urea removal module comprising a second sorbent cartridge having at least urease and zirconium phosphate or magnesium phosphate therein, the urea removal module further comprising a second dialysis circuit and one or more second connectors for attaching the second dialysis circuit to the dialysate inlet and the dialysate outlet;

wherein the second dialysis circuit comprises one or more second control reservoirs and one or more second control pumps, the one or more second control pumps configured to be controlled by the one or more controllers;

conveying dialysate through the second dialysis circuit such that the dialysate moves from the second sorbent cartridge to the dialyzer and back to the second sorbent cartridge, wherein the blood and the dialysate are in fluid communication through the dialysis membrane and urea diffuses from the blood to the dialysate;

removing urea from the dialysate during the second period of time wherein the urea is removed by the second sorbent cartridge;

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 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, without the use of scales or gravimetric methods.

12. The method of claim 11, further comprising monitoring the conductivity of the dialysate at a location between the dialyzer and an inlet end of the second sorbent cartridge with a first conductivity meter;

monitoring the conductivity of the dialysate at a position between an outlet end of the second sorbent cartridge and the dialyzer with a second conductivity meter; and

calculating an amount of urea absorbed by the second sorbent cartridge based at least in part upon the conductivity measured at the inlet end of the second sorbent cartridge and at the outlet end of the second sorbent cartridge.

13. The method of claim 11, further comprising operating either the first control pump or the second control pump that adds fluid from a control reservoir to the first or second dialysis circuit in an influx direction via a conduit or removes fluid from the first or second dialysis circuit to the control reservoir in an efflux direction via the conduit, and intermittently switching the first control pump or second control pump between the efflux direction to move fluid across the dialysis membrane from the extracorporeal circuit to the first or second dialysis circuit and the influx direction to move fluid across the dialysis membrane from the first or second dialysis circuit to the extracorporeal circuit,

wherein the intermittent switching of the pump accomplishes the convective clearance of at least one waste species having a molecular weight less than about 66000 g/mol and greater than about 1000 g/mol.

14. The method of claim 13, wherein the first control pump or second control pump operates to pump a larger volume in the efflux direction compared with the influx direction over a period of time.

15. The method of claim 13, wherein the first control pump or second control pump operates to pump a volume in the efflux direction that is at least about 10% greater compared to a volume pumped in the influx direction over a period of time.

16. A method comprising:

attaching the vasculature of a patient to an extracorporeal circuit having a first end that draws blood from the patient, a second end that returns blood to the patient, and a hemofilter, said hemofilter having a hemofiltration membrane, a blood inlet, a blood outlet, an ultrafiltrate outlet, and a second port;

attaching the ultrafiltrate outlet of the hemofilter to a portable module, 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;

wherein the second port of the hemofilter remains sealed during operation of the portable module;

wherein one or more controllers controls the filtrate control pump so that ultrafiltrate is separated and removed from the blood in the extracorporeal circuit and also so that blood is conveyed from the patient, through the extracorporeal circuit and the hemofilter, and returned to the patient;

operating the filtrate pump to separate and remove an ultrafiltrate from the blood in the extracorporeal circuit for a first period of time;

disconnecting the portable module from the hemofilter;

attaching the ultrafiltrate outlet and the dialysate inlet to a controlled compliant urea removal module, the urea removal module comprising a sorbent cartridge having at least urease and zirconium phosphate or magnesium phosphate therein, the urea removal module further comprising a dialysis circuit and one or more second connectors for attaching the dialysis circuit to the ultrafiltrate outlet and to the second port;

wherein the dialysis circuit of the urea removal module comprises one or more second control reservoirs and one or more control pumps, the one or more second control pumps configured to be controlled by the one or more controllers;

conveying dialysate through the dialysis circuit such that the dialysate moves from the sorbent cartridge to the hemofilter and back to the sorbent cartridge, wherein the blood and the dialysate are in fluid communication through the hemofiltration membrane and one or more waste products diffuses from the blood to the dialysate;

removing the one or more waste products from the dialysate during a second period of time wherein the urea is removed by the sorbent cartridge;

wherein the one or more second control pumps are configured to provide selective adjustment of the volume of the second dialysis circuit by

(A) operating in an influx direction so that fluid moves from the one or more second control reservoirs to the second dialysis circuit; and

(B) 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 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, without the use of scales or gravimetric methods.

17. The method of claim 16, further comprising operating either the first control pump or second control pump to add fluid from a control reservoir to the dialysis circuit in an influx direction via a conduit, and operating either the first control pump or second control pump to remove fluid from the dialysis circuit to the control reservoir in an efflux direction via a conduit, and intermittently switching between pumping fluid in the efflux direction to move fluid across the dialysis membrane from the extracorporeal circuit to the dialysis circuit and the influx direction to move fluid across the dialysis membrane from the dialysis circuit to the extracorporeal circuit,

wherein the intermittent switching between pumping in the efflux and influx directions accomplishes the convective clearance of at least one waste species having a molecular weight less than about 66000 g/mol and greater than about 1000 g/mol.

18. The method of claim 16, wherein pumping in the efflux and influx directions is intermittently switched between the efflux direction and the influx direction at least once every minute.

19. The method of claim 16, wherein at least one of the one or more control pumps operates to pump a larger volume in the efflux direction compared with the influx direction over a period of time.