Medicament preparation and treatment devices, methods, and systems

Patent metadata

Field	Value
Publication number	US-11167069-B2
Application number	US-201916575482-A
Country	US
Kind code	B2
Filing date	Sep 19, 2019
Priority date	Sep 25, 2014
Publication date	Nov 9, 2021
Grant date	Nov 9, 2021

Abstract

A medicament preparation system, according to an embodiment, includes a water purification module and a medicament proportioning module. The system is configured to allow convenient and safe use in a home environment or a critical care environment as well as others affording safety, reliability, and a compact form factor.

First claim

The invention claimed is:

1. A compact medicament supply system to support blood treatment systems susceptible to a leakage current from an electric heater used to heat medicament due to a formation of a fluid path between the electric heater and a patient, the system comprising:
a water purification module that includes
a pump,
a water purification controller, and
deionization filters, the pump being controlled to purify input water, by conveying the input water through the deionization filters, to a level of purity exceeding 1 megaohm-cm and to output product water of at least that level of purity to a product water outlet connected to the electric heater;

a water channel of a predefined length and made from an electrically insulating material connecting the electric heater to a disposable fluid circuit of a medicament proportioning module, the water channel receiving said product water from said electric heater;
the electric heater being of a configuration that places the product water in direct contact with permanent non-disposable surfaces of a flow channel in said electric heater;
a sterile filter connected to receive said product water at a point along said water channel, the water channel having a output connector for connecting to the medicament proportioning module;
the medicament proportioning module, constructed at least partially of an electrically insulating material, and connected to supply a conductive medicament solution to a treatment component that is connected to the patient via a blood circuit including a patient access such that a continuous fluid path is formed between said electric heater and said patient access at times during a treatment;
a controller configured to control the electric heater responsively to a measured temperature and temperature target selected for maintaining a body temperature of the patient connected via the blood circuit to the treatment component, the controller compensating for heat load due an addition of medicament concentrate to a flow of the product water; and
a length of the water channel and a resistivity of the product water therein being sufficient to ensure that said electric heater produces less than 50 microamperes of leakage current through said continuous fluid path to said patient access, whereby heat required to maintain body temperature of a patient being treated by a blood treatment is provided through an electrically insulating convective flow of the product water used for generation of medicament used in the treatment.

2. The system of claim 1 , wherein said electric heater has double-insulated heating elements.

3. A method for regulating a temperature of medicament for extracorporeal blood processing, comprising:
providing purified water of a predefined resistivity;
using an electric heating element that generates heat, heating said pure purified water;
flowing the purified water through an electrically insulating channel of such length and cross-section, and said predefined resistivity being such as to ensure that a leakage current of less than 50 microamperes reaches an end of the electrically insulating channel;
diluting or dissolving a medicament solute with a flow of said purified water starting at said end at a rate to achieve a concentration of a product medicament resulting from said diluting or dissolving suitable for immediate use in an extracorporeal blood treatment; and
regulating a rate of said heating of said purified water to ensure that a temperature of said product medicament maintains a temperature of a patient during the extracorporeal blood treatment that consumes said product medicament, wherein
a resistive water path is effective to electrically insulate said electric heating element from the patient receiving the extracorporeal blood treatment to safeguard against a health risk from the leakage current.

4. The method of claim 3 , wherein the providing includes deionizing source water to produce said purified water.

5. The method of claim 3 , further comprising sterile-filtering the purified water prior to said diluting or dissolving.

6. The method of claim 3 , wherein the diluting or dissolving includes injecting medicament concentrate into a flow of the purified water using a disposable fluid circuit.

7. The method of claim 4 , further comprising regulating a rate of production of the purified water responsively to a rate of consumption of the product medicament by said extracorporeal blood treatment.

8. The method of claim 4 , further comprising regulating a patient temperature by regulating a rate of heat addition to the purified water that has a resistivity of at least 100 Kiloohm-cms.

9. The method of claim 8 , further comprising regulating a rate of production of the purified water responsively to a rate of consumption of the product medicament by said extracorporeal blood treatment.

10. The method of claim 3 , further comprising regulating a rate of production of the purified water, wherein
the heat applied to the purified water is proportional to a rate of consumption of the product medicament by said extracorporeal blood treatment.

11. A method for supplying medicament to a blood processing system, comprising:
filtering source water to increase a resistivity thereof to a level of at least 1 megaohm-cm to generate high resistivity product water;
electrically heating the high resistivity product water resulting from said filtering with an electric heater, the electrically heating including continuously regulating a temperature of the high resistivity product water to maintain to a target temperature calculated to maintain a body temperature of a patient receiving a blood treatment with the blood processing system, the electrically heating occurring over a course of said blood treatment;
reducing a voltage difference between the patient and the electric heater through a channel filled with the high resistivity product water whose dimensions are effective to reduce an electric current through said channel to less than 50 microamperes;
adding a medicament concentrate to said high resistivity product water resulting from said electrically heating to generate a product medicament; and
fluidly and electrically interfacing said product medicament with a patient blood circuit connected to the patient undergoing the blood treatment.

12. The method of claim 11 , wherein the electrically heating includes pulse-width modulating the electric heater.

13. The method of claim 11 , wherein the voltage difference is generated by capacitively coupling a conducting circuit with fluid, in a fluid channel, that is fluidly coupled to said product medicament.

14. The method of claim 11 , wherein the filtering the source water includes deionizing the source water in a deionization filter bed, and
the source water is tap water.

15. The method of claim 11 , wherein the filtering the source water increases a resistivity thereof to a level of at least 3 megaohm-cm.

16. The method of claim 11 , wherein the filtering the source water increases a resistivity thereof to a level of at least 5 megaohm-cm.

17. The method of claim 11 , wherein the filtering the source water increases a resistivity thereof to a level of at least 10 megaohm-cm.

18. The method of claim 11 , wherein the electrically heating places said high resistivity product water in direct contact with a permanent electrical heater which is not replaced between uses, the electrically heating being followed by sterile-filtering said high resistivity product water.

19. The method of claim

Assignees

• Nxstage Medical Inc

Inventors

• Friederichs Goetz
• Weigel William K
• Treu Dennis M
• Burbank Jeffrey H
• Brugger James M
• Wheeler Keith David J
• Newell Scott W

Classifications

• B01F21/20

  using flow mixing · CPC title

• C02F2209/05

  Conductivity or salinity · CPC title

• C02F1/42

  by ion-exchange (ion-exchange in general B01J) · CPC title

• C02F2103/026

  Treating water for medical or cosmetic purposes · CPC title

• Y02A50/30

  Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change · CPC title