Electrochemically controlled faradic stimulation of osteogenesis

• US 5,458,627 A
• Filed: 07/15/1993
• Issued: 10/17/1995
• Est. Priority Date: 10/15/1992
• Status: Expired due to Fees

• Current Assignee: Electro-Biology Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Electro-Biology Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Baranowski, Thomas J. Jr., Black, Jonathan
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/092,274
• Time in Patent Office: 824 Days
• Field of Search: 607/50, 607/51, 607/52
• US Class Current: 607/51
• CPC Class Codes: A61N 1/205 for promoting a biological process

Abstract

Invented are methods and an apparatus for faradic stimulation of osteogenesis by control of electrochemical reactions through maintenance of a stimulus between a cathode and anode yielding only beneficial electrochemical reactions at the cathode, the site of desired osteogenesis, while preventing any detrimental reaction at the same. Said methods and apparatus maintain a stimulus yielding the maximum acceptable level of oxygen consumption and pH elevation at the cathode, either with or without the formation of hydrogen peroxide as only an intermediate chemical species, while preventing the initiation of hydrogen gas evolution at the same such that the stimulus results in depression of oxygen tension plus elevation of pH, environmental effects that favor osteogenesis, and prevents a reaction resulting in elevation of pH plus hydrogen gas evolution, the latter effect being detrimental to the same.

Claims

1. An apparatus for faradic stimulation of osteogenesis by control of electrochemical reactions occurring at a site of desired osteogenesis, said apparatus comprising:

means for producing faradic stimulation at said site;

closed-loop control means for maintaining said faradic stimulation at a level producing substantial osteogenic response while preventing initiation of hydrogen evolution, said closed-loop control means including means for repetitively identifying the onset of hydrogen evolution and adjusting said stimulation to a level near and below that corresponding to the identified onset of hydrogen evolution.

2. The apparatus of claim 1, wherein said closed-loop control means further includes means for measuring pH at said site.

3. The apparatus of claim 2, wherein said closed-loop control means further includes means for measuring oxygen tension at said site.

4. The apparatus of claim 1, wherein said closed-loop control means further includes means for measuring oxygen tension at said site.

5. The apparatus of claim 1, wherein said means for producing faradic stimulation includes a first electrode adapted to be placed at said site and a second electrode remote from said site, and wherein said closed-loop control means further includes means for measuring voltage and current between said first and second electrodes over a range sufficient to produce at least a portion of an identifiable voltage-current relationship having first, second and third regions, means for determining the transition zone between said second and third regions, and means for determining shifts in the transition zone.

6. The apparatus of claim 5, further comprising means for temporarily interrupting said faradic stimulation, and means for enabling said closed-loop control means during the period of interruption.

7. A method of faradic stimulation of osteogenesis by control of electrochemical reactions occurring at a site of desired osteogenesis, said method comprising the steps:

producing faradic stimulation at said site;

maintaining said faradic stimulation at a level producing substantial osteogenic response while preventing initiation of hydrogen evolution, said maintaining step including repetitively identifying the onset of hydrogen evolution and adjusting said stimulation to a level near and below that corresponding to the identified onset of hydrogen evolution.

8. The method of claim 7, further comprising the step of measuring pH at said site.

9. The method of claim 8, further comprising the step of measuring oxygen tension at said site.

10. The method of claim 7, further comprising the step of measuring oxygen tension at said site.

11. The method of claim 7, wherein said faradic stimulation is produced with a first electrode at said site and a second electrode remote from said site, and wherein said maintaining step further includes measuring voltage and current between said first and second electrodes over a range sufficient to produce at least a portion of an identifiable voltage-current relationship having first, second and third regions, determining the transition zone between said second and third regions, and determining shifts in the transition zone.

12. The method of claim 11, further comprising the steps of temporarily interrupting said faradic stimulation and performing said identifying and adjusting steps during the period of interruption.

13. A method for electrochemically controlled stimulation of osteogenesis, wherein said method comprises:

providing a first electrode with a conduction exposure;

providing a second electrode with a conductive exposure;

monitoring current and potential between said first electrode and said second electrode to ascertain the electrochemical behavior of said first electrode and said second electrode; and

applying initially and adjusting periodically an electrical signal between said first electrode and said second electrode to cause and maintain an electrochemical process of a first type at said first electrode but not an electrochemical process of a second type at said first electrode.

14. A method according to claim 13, wherein said method further comprises:

providing a first reference electrode with a conductive exposure;

locating said first reference electrode remote from said first electrode and said second electrode; and

monitoring potentials of said first electrode and said second electrode, each with respect to said first reference electrode, to further ascertain the electrochemical behavior of said first electrode and said second electrode.

15. A method according to claim 14, wherein said method further comprises:

providing a second reference electrode with conductive exposure;

providing a third reference electrode with a conductive exposure;

providing an oxygen tension electrode with an oxygen sensitive exposure;

providing a pH electrode with a hydrogen ion selective exposure;

locating said second reference electrode remote from said first electrode and said second electrode;

locating said third reference electrode remote from said first electrode and said second electrode;

locating said oxygen sensitive exposure of said oxygen tension electrode at said conductive exposure of said first electrode;

locating said hydrogen ion selective exposure of said pH electrode at said conductive exposure of said first electrode; and

monitoring oxygen tension and pH at said conductive exposure of said first electrode to further ascertain the electrochemical behavior of said first electrode.

16. A method according to claim 15, wherein:

said second reference electrode is located in living tissue;

said third reference electrode is located in living tissue;

said oxygen tension electrode is located in living tissue; and

said pH electrode is located in living tissue.

17. A method according to claim 14, wherein:

said first reference electrode is located in living tissue.

18. A method according to claim 13, wherein:

said first electrode is a negative electrode at which reduction occurs and from which current is being forced; and

said second electrode is a positive electrode at which oxidation occurs and to which current is being forced.

19. A method according to claim 13, wherein:

said electrochemical process of said first type at said first electrode is beneficial to osteogenesis; and

said electrochemical process of said second type at said first electrode is detrimental to osteogenesis.

20. A method according to claim 13, wherein:

said electrochemical process of said first type at said first electrode is consumption of oxygen and elevation of pH, with or without formation of hydrogen peroxide; and

said electrochemical process of said second type at said first electrode is evolution of hydrogen and elevation of pH.

21. A method according to claim 13, wherein:

said first electrode is located with its conductive exposure at a tissue site in living tissue where osteogenesis is desired; and

said second electrode is located with its conductive exposure in said living tissue remote from said tissue site.

22. A method according to claim 21, wherein:

said living tissue includes skin surface.

23. An apparatus for electrochemically controlled stimulation of osteogenesis, wherein said apparatus comprises:

a first electrode with a conductive exposure;

a second electrode with a conductive exposure;

an acquisition means for monitoring current and potential between said first electrode and said second electrode to ascertain the electrochemical behavior of said first electrode and said second electrode;

an electrical signal means for producing an electrical signal between said first electrode and said second electrode; and

a control means for applying initially and adjusting periodically said electrical signal between said first electrode and said second electrode to cause and maintain an electrochemical process of a first type at said first electrode but not an electrochemical process of a second type at said first electrode.

24. An apparatus according to claim 23, wherein said apparatus further comprises:

a first reference electrode with a conductive exposure located remote from said first electrode and said second electrode; and

an acquisition means for monitoring potentials of said first electrode and said second electrode, each with respect to said first reference electrode, to further ascertain the electrochemical behavior of said first electrode and said second electrode.

25. An apparatus according to claim 24, wherein said apparatus further comprises:

a second reference electrode with a conductive exposure located remote from said first electrode and said second electrode;

a third reference electrode with a conductive exposure located remote from said first electrode and said second electrode;

an oxygen tension electrode with an oxygen sensitive exposure located at said conductive exposure of said first electrode;

a pH electrode with an hydrogen ion selective exposure located at said conductive exposure of said first electrode; and

an acquisition means for monitoring oxygen tension and pH at said conductive exposure of said first electrode to further ascertain the electrochemical behavior of said first electrode.

26. An apparatus according to claim 25, wherein:

said second reference electrode is adapted to be located in living tissue;

said third reference electrode is adapted to be located in living tissue;

said oxygen tension electrode is adapted to be located in living tissue; and

said pH electrode is adapted to be located in living tissue.

27. An apparatus according to claim 24, wherein:

said first reference electrode is adapted to be located in living tissue.

28. An apparatus according to claim 23, wherein:

said first electrode is a negative electrode at which reduction occurs and from which current is being forced; and

said second electrode is a positive electrode at which oxidation occurs and to which current is being forced.

29. An apparatus according to claim 23, wherein:

said electrochemical process of said first type at said first electrode is beneficial to osteogenesis; and

said electrochemical process of said second type at said first electrode is detrimental to osteogenesis.

30. An apparatus according to claim 23, wherein:

said electrochemical process of said first type at said first electrode is consumption of oxygen and elevation of pH, with or without formation of hydrogen peroxide; and

said electrochemical process of said first type at said first electrode is evolution of hydrogen and elevation of pH.

31. An apparatus according to claim 23, wherein:

said first electrode is adapted to be located with its conductive exposure at a tissue site in living tissue where osteogenesis is desired; and

said second electrode is adapted to be located with its conductive exposure in said living tissue remote from said tissue site.

32. An apparatus according to claim 31, wherein:

said living tissue includes skin surface.