Method and assembly for the generation of signal shapes for healing wounds by electro-stimulation

• US 10,441,784 B2
• Filed: 12/14/2016
• Issued: 10/15/2019
• Est. Priority Date: 07/15/2011
• Status: Active Grant

• Current Assignee: Q Care Medical Services
• Original Assignee: Q Care Medical Services
• Inventors: Bollen, Marc, Ponsaerts, Filip
• Primary Examiner(s): Lee, Erica S
• Application Number:
  US15/378,643
• Publication Number:
  US 20170151431A1
• Time in Patent Office: 1,035 Days
• Field of Search: None
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

A method for generating a signal shape (w1) for an electro-stimulation signal (w1) for healing wounds by electro-stimulation by way of an electrode (E1) which has an encoding member (6) with a code word (cw) which identifies therapeutic treatments, and is coupled to indicators (i1, i2) which indicate which treatments have to be activated. The signal shape (w1) is formed systematically from base signals capable of being parameterized such as a DC signal and two pulse trains, the parameters and the timing of which are formed systematically and applied where necessary, in accordance with the combined therapies. The generation of signal shapes for a plurality of electrodes is also disclosed.

Claims

1. A method for generating signal shapes of electro-stimulation signals to be supplied to electrodes for healing wounds by micro-current electro-stimulation, the method comprising the steps of:

a) connecting a first electrode to a first port of a signal shape generator, wherein the first electrode is connected to a first encoding member in which a first code word is stored, the first code word identifying at least one first therapeutic treatment to be applied by the first electrode,

b) connecting a second electrode to a second port of the signal shape generator, wherein the second electrode is connected to a second encoding member in which a second code word is stored, the second code word identifying at least one second therapeutic treatment to be applied by the second electrode,

c) connecting a central contact to a third port of the signal shape generator, the central contact being provided for contact with skin and for use as a return channel of microcurrents which are applied by the electrodes,

d) positioning the first and second electrodes and the central contact for treatment of at least one wound,

e) retrieving from the first and second encoding members the first and second code words,

f) retrieving at least one first signal associated with the at least one first therapeutic treatment identified by the first code word and the formation of a first temporary signal shape on the basis of the at least one first signal,

g) retrieving at least one second signal associated with the second therapeutic treatment identified by the second code word and the formation of a second temporary signal shape on the basis of the at least one second signal,

h) checking the first and second temporary signal shapes in order to establish whether or not the combination of the first and second temporary signal shapes falls within therapeutic limits of the therapeutic treatments identified by the code words,

i) adjusting at least one of the first and second temporary signal shapes so as to fall within the therapeutic limits if it has been established that the combination of the first and second temporary signal shapes did not fall within the therapeutic limits, and

j) forming, by the signal shape generator, first and second wound healing electro-stimulation signals on the basis of respectively the first temporary signal shape and the second temporary signal shape and applying the first and second wound healing electro-stimulation signals to respectively the first electrode and the second electrode, the first and second wound healing electro-stimulation signals being micro-current signals having an amplitude of less than 1 mA,

wherein at least one of the first and second code words comprises at least four code word portions, wherein the first code word portion identifies an antibacterial treatment, the second code word portion identifies a cell migration treatment, the third code word portion identifies a treatment for pain and/or a treatment for the increase in the oxygen tension TcPO2, and the fourth code word portion identifies a stimulation of one or more processes selected from the group consisting of ATP production, DNA production, protein production, and amino acid absorption.

2. The method according to claim 1,

wherein the first temporary signal shape comprises a first DC signal with a first direct current (DC) value during a first period, and wherein the second temporary signal shape comprises a second DC signal with a second DC value during a second period not overlapping with the first period, and

wherein the adjustment comprises changing the first DC value to a third DC value lying in a range with the first DC value and the second DC value as the limit values.

3. The method according to claim 2, wherein the adjustment of the first DC value is setting the first DC value equal to the smallest DC value of the first DC value and the second DC value.

4. The method according to claim 1,

wherein the first temporary signal shape comprises a first direct current (DC) signal with a first DC value during a first period,

wherein the second temporary signal shape comprises a first pulse train with a first frequency lower than a predetermined frequency and with a first pulse amplitude and with a first pulse width, the first pulse train being active during a second period not overlapping with the first period, and

wherein the adjustment comprises either reducing the first DC value to a reduced DC value or reducing the first pulse amplitude to a reduced first pulse amplitude.

5. The method according to claim 4, wherein the predetermined frequency is a frequency in the range of from 20 to 50 Hz.

6. The method according to claim 4, wherein the predetermined frequency is a frequency substantially equal to 30 Hz.

7. The method according to claim 1,

wherein the first temporary signal shape comprises a first pulse train with a first frequency lower than a predetermined frequency and with a first pulse amplitude and with a first pulse width, and

wherein the second temporary signal shape comprises a second pulse train with a second frequency higher than the predetermined frequency and with a second pulse amplitude and with a second pulse width, the second pulse train being active during a second period not overlapping with the first period.

8. The method according to claim 1,

wherein at least one of the first and second code words comprises a plurality of code word portions, and

wherein each code word portion respectively identifies a different therapeutic treatment.

9. The method according to claim 1,

wherein one of the therapeutic treatments is an antibacterial treatment, and

wherein a direct current (DC) signal with a DC value of from 4 to 750 μ

A is selected as the signal associated with this therapeutic treatment.

10. The method according to claim 1,

wherein one of the therapeutic treatments is an antibacterial treatment, and

wherein a direct current (DC) signal with a DC value of from 300 to 500 μ

A is selected as the signal associated with this therapeutic treatment.

11. The method according to claim 1,

wherein one of the therapeutic treatments is an antibacterial treatment, and

wherein a direct current signal with a DC value of approximately 400 μ

A is selected as the signal associated with this therapeutic treatment.

12. The method according to claim 1,

wherein one of the therapeutic treatments is a cell migration treatment, and

wherein a direct current (DC) signal with a DC value of from 50 to 750 μ

A is selected as the signal associated with this therapeutic treatment.

13. The method according to claim 1,

wherein one of the therapeutic treatments is a cell migration treatment, and

wherein a direct current signal with a DC value of approximately 100 μ

A is selected as the signal associated with this therapeutic treatment.

14. The method according to claim 1,

wherein one of the therapeutic treatments is a treatment for pain and/or a treatment for the increase in the oxygen tension TcPO2, and

wherein a first pulse train with a first frequency of from 0.2 to 20.0 Hz, with a first pulse amplitude of from 10 to 750 μ

A, and with a first pulse width of from 0.1 to 2.0 ms, is selected as the signal associated with this therapeutic treatment.

15. The method according to claim 1,

wherein one of the therapeutic treatments is a treatment for pain and/or a treatment for the increase in the oxygen tension TcPO2, and

wherein a first pulse train with a first frequency of approximately 5.0 Hz, with a first pulse amplitude of from 100 to 400 μ

A, and with a first pulse width of from 1.0 to 3.0 ms, is selected as the signal associated with this therapeutic treatment.

16. The method according to claim 1,

wherein one of the therapeutic treatments is a stimulation of a process selected from the group of ATP production, DNA production, protein production, and amino acid absorption, and

wherein a second pulse train with a second frequency of from 50 to 160 Hz, with a second pulse amplitude of from 10 to 750 μ

A, and with a second pulse width of from 0.1 to 5.0 ms, is selected as the signal associated with this therapeutic treatment.

17. The method according to claim 1,

wherein one of the therapeutic treatments is a stimulation of a process selected from the group of ATP production, DNA production, protein production, and amino acid absorption, and

wherein a second pulse train with a second frequency of approximately 100 Hz, with a second pulse amplitude of from 100 to 400 μ

A, and with a second pulse width of from 0.2 to 2.0 ms, is selected as the signal associated with this therapeutic treatment.

18. The method according to claim 1,

wherein the first temporary signal shape comprises a first pulse train with a first frequency, with a first pulse amplitude, and with a first pulse width, the first pulse train being active during a first period,

wherein the second temporary signal shape comprises a second pulse train with a second frequency and second pulse amplitude and with a second pulse width, the second pulse train being active during a second period not overlapping with the first period, and

wherein the adjustment comprises shifting the second temporary signal shape in time, such that pulses of the first and second pulse trains do not overlap after the shifting.