USRE35129E - Optimization of bone formation at cathodes - Google Patents
Optimization of bone formation at cathodes Download PDFInfo
- Publication number
- USRE35129E USRE35129E US08/138,230 US13823093A USRE35129E US RE35129 E USRE35129 E US RE35129E US 13823093 A US13823093 A US 13823093A US RE35129 E USRE35129 E US RE35129E
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- United States
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- electrodes
- electrode
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- Expired - Lifetime
Links
- 230000011164 ossification Effects 0.000 title claims description 13
- 238000005457 optimization Methods 0.000 title description 3
- 230000007704 transition Effects 0.000 claims abstract description 35
- 238000000034 method Methods 0.000 claims abstract description 29
- 238000012544 monitoring process Methods 0.000 claims abstract description 17
- 230000008569 process Effects 0.000 claims description 13
- 230000017423 tissue regeneration Effects 0.000 claims description 8
- 230000000638 stimulation Effects 0.000 claims description 5
- 230000004936 stimulating effect Effects 0.000 claims 4
- 230000008878 coupling Effects 0.000 claims 3
- 238000010168 coupling process Methods 0.000 claims 3
- 238000005859 coupling reaction Methods 0.000 claims 3
- 210000003127 knee Anatomy 0.000 description 17
- 210000001519 tissue Anatomy 0.000 description 12
- 230000008859 change Effects 0.000 description 6
- 229910001220 stainless steel Inorganic materials 0.000 description 6
- 239000010935 stainless steel Substances 0.000 description 6
- 239000010936 titanium Substances 0.000 description 6
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 5
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 5
- 229910052719 titanium Inorganic materials 0.000 description 5
- 230000015572 biosynthetic process Effects 0.000 description 3
- 210000000988 bone and bone Anatomy 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 229910052751 metal Inorganic materials 0.000 description 3
- 230000002188 osteogenic effect Effects 0.000 description 3
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 229910052799 carbon Inorganic materials 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-M hydroxide Chemical compound [OH-] XLYOFNOQVPJJNP-UHFFFAOYSA-M 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 229910052697 platinum Inorganic materials 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 206010065687 Bone loss Diseases 0.000 description 1
- 206010031264 Osteonecrosis Diseases 0.000 description 1
- 229910021607 Silver chloride Inorganic materials 0.000 description 1
- 239000010405 anode material Substances 0.000 description 1
- 230000008468 bone growth Effects 0.000 description 1
- 239000007795 chemical reaction product Substances 0.000 description 1
- GTKRFUAGOKINCA-UHFFFAOYSA-M chlorosilver;silver Chemical compound [Ag].[Ag]Cl GTKRFUAGOKINCA-UHFFFAOYSA-M 0.000 description 1
- 239000002322 conducting polymer Substances 0.000 description 1
- 229920001940 conductive polymer Polymers 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 238000003411 electrode reaction Methods 0.000 description 1
- 238000004070 electrodeposition Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 230000017074 necrotic cell death Effects 0.000 description 1
- 230000004962 physiological condition Effects 0.000 description 1
- HKZLPVFGJNLROG-UHFFFAOYSA-M silver monochloride Chemical compound [Cl-].[Ag+] HKZLPVFGJNLROG-UHFFFAOYSA-M 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/20—Applying electric currents by contact electrodes continuous direct currents
- A61N1/205—Applying electric currents by contact electrodes continuous direct currents for promoting a biological process
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/326—Applying electric currents by contact electrodes alternating or intermittent currents for promoting growth of cells, e.g. bone cells
Definitions
- the present invention relates generally to electrically-induced osteogenesis and more specifically to an improved method and apparatus for optimizing stimulated osteogenesis.
- the current between cathodes of materials such as stainless steel, platinum, titanium or carbon and an appropriately chosen anode rises slowly with applied voltage until a voltage zone is reached at which the current increases more rapidly for small increases in voltage.
- This transition region (“knee") of the current-voltage characteristic or curve corresponds with the onset of chemical reactions such as oxygen reduction and hydroxide ion formation in the region of the cathode.
- the knee occurs at an inter-electrode voltage of about 2.4 volts in physiological conditions for anode-cathode pairs such as stainless steel-stainless steel.
- the position of the knee also depends on tissue impedance (which changes over time) and electrode position, among other variables.
- Another object of the present invention is to provide an apparatus and method for optimising osteogenic stimulation which adapts for variation in the tissue impedance and cathode properties over time.
- varying signals to a first electrode at the tissue site and a second electrode remote from the tissue site and monitoring the results to determine a distinctive transition (knee) in the current-voltage characteristics of the pair of electrodes.
- a signal is then selected and applied to the electrodes to operate beyond the transition.
- varying signals are applied to the two electrodes and the monitoring process reperformed to determine a new transition and the appropriate signal is selected to operate beyond the transition.
- the current between the electrodes is typically between 10 and 50 microamps and an appropriate voltage is selected to operate beyond the transition.
- each cathode may be optimised independently as described for single cathodes.
- a branched or multiport cathode may be convenient, and currents typically between 10 and 50 microamps per branch or port may be chosen at potentials beyond the transition as determined for the assembly.
- FIG. 1 is a side view of a prior art osteogenesis electrode arrangement
- FIG. 2a is a typical graph of the current-voltage characteristics of an anode and cathode pair
- FIG. 2b shows the graph of FIG. 2a within the current shown in a logarithmic scale
- FIG. 3 is a block diagram of a osteogenic stimulator according to the principles of the present invention.
- the two optima may be fairly close together for cathodes of the form used to date by selecting an appropriate anode material and geometry (electrode length, diameter and folding).
- the present invention for the optimization of both the current and voltage, is substantially independent of the materials chosen and number of ports and is capable of adapting to changes in cathode geometry and of the impedance at the tissue site.
- the voltage applied between the anode and cathode has a substantial and definite rise as the current increases until a narrow region is reached beyond which the current increases rather rapidly for small increments of the applied voltage.
- This change in trend is here described as a transition or knee, corresponding with the onset of chemical reactions such as oxygen reduction and hydroxide ion formation in the region of the cathode.
- the present invention has determined that optimum parameters for current-voltage are likely to be at potentials a little above the knee.
- the present invention monitors the applied voltage difference between the anode and cathode for various currents to determine the knee of the resulting curves.
- the impedance and composition of the region being treated may change with progression of healing.
- the position of the knee on a current-voltage characteristic shifts with time and must be adjusted to maintain the current-voltage characteristic beyond the knee.
- a system that is illustrated in FIG. 3 includes an anode port 42 and a cathode port 44 connectable to the anode 22 and cathode 18 with the cathode being at the tissue site.
- a controller 50 for example a microcomputer, provides a digital signal to digital to analog device 52 whose output is an analog voltage. This voltage is applied to the voltage/current converter 46 which provides an output current to the anode terminal 42.
- the anode terminal 42 and cathode terminal 44 are connected to multiplexer 54 which provides, selectively, the voltage at the anode or the cathode to analog to digital converter 56.
- the output of the A/D converter 56 is a digital signal provided back to the controller 50.
- the process is carried out by providing varying signals to the ports 42 and 44 to produce the varying current-voltage characteristic graph. Once the knee of the curve is determined for that period of time, the voltage and current are then set to operate beyond the knee. Periodically, for example, every twelve hours, the process is repeated to determine the new current-voltage characteristic graph and then selecting an appropriate voltage/current characteristic to operate beyond the knee.
- This process is carried out by the controller 50 supplying increasing values of voltage to the voltage to current converter 46 which provides increasing values of current to the anode electrode 42.
- the controller 50 reads the cathode and anode voltage with respect to an internal ground by controlling the multiplexer 54 and the A/D converter 56.
- the controller 50 will then compute the change of voltage per change of current and determined the decreased in change of voltage per change of current step to determine the existence of the knee. Once the knee has been determined, the controller 50 provides an appropriate voltage through the D/A converter 52 to set the appropriate current to the anode port 42 through the voltage to current converter 46.
- the controller 50 has an internal timer which periodically reinvestigates the location of the knee and varies the appropriate signal being sent to the electrode.
- a typical example for the controller 50 would be a microcomputer 68HC805 by Motorola.
- the voltage to current converter may simply be an operational amplifier receiving on the positive terminal the output of the D/A converter 52 and on the minus terminal the feedback signal from the cathode port 44.
- variable voltage may be provide as an input to the voltage to current converter 46 and the output from the anode port 42 and cathode port 44 may be provided to a monitor which would display the voltage-current characteristics.
- an operator can vary the input voltage and determine visually the location of the knee and thereby set the appropriate signal to achieve the desired operating characteristics. Periodically, the operator would reperform this process by changing the voltage input to the voltage to current converter 46 to redetermine the location of the knee and thereby set an appropriate voltage input.
- the current range of operation is in the 10 to 50 microamperes range.
- each cathode may be optimised independently as described for single cathodes.
- a branched or multiport cathode may be convenient, and currents typically between 10 and 50 microamps per branch or port may be chosen at potentials beyond the transition as determined for the assembly.
- the cathode may, per example, be stainless steel, titanium or a carbon cathode whereas the anode may be for example, stainless steel mesh or a platimum-plated titanium or other inert metals or other tissue-compatable electrodes such as salt bridge or conducting polymers.
- the cathode or anode may be attached to insulated leads.
- the anode may be placed transcutaneous, percutaneous or totally implanted and that the cathode may be placed transcutaneously or fully implanted. Insulated leads which may be attached to the anode or cathode may also be placed percutaneously or totally implanted.
- the stimulator or signal generator may be totally implanted or may be external and connected to the electrodes by leads or inductivity.
- the present invention is not to be limited to fractures but to any bone growth process including spinal fusion, for example.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Neurology (AREA)
- Molecular Biology (AREA)
- Cell Biology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Electrotherapy Devices (AREA)
Abstract
Description
Claims (24)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/138,230 USRE35129E (en) | 1990-07-02 | 1993-10-15 | Optimization of bone formation at cathodes |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/547,821 US5056518A (en) | 1990-07-02 | 1990-07-02 | Optimization of bone formation at cathodes |
US08/138,230 USRE35129E (en) | 1990-07-02 | 1993-10-15 | Optimization of bone formation at cathodes |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/547,821 Reissue US5056518A (en) | 1990-07-02 | 1990-07-02 | Optimization of bone formation at cathodes |
Publications (1)
Publication Number | Publication Date |
---|---|
USRE35129E true USRE35129E (en) | 1995-12-19 |
Family
ID=24186271
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/547,821 Ceased US5056518A (en) | 1990-07-02 | 1990-07-02 | Optimization of bone formation at cathodes |
US08/138,230 Expired - Lifetime USRE35129E (en) | 1990-07-02 | 1993-10-15 | Optimization of bone formation at cathodes |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/547,821 Ceased US5056518A (en) | 1990-07-02 | 1990-07-02 | Optimization of bone formation at cathodes |
Country Status (1)
Country | Link |
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US (2) | US5056518A (en) |
Cited By (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2000078267A2 (en) | 1999-06-08 | 2000-12-28 | Medical Bracing Systems Ltd. | Pemf biophysical stimulation field generator and method |
US6423061B1 (en) | 2000-03-14 | 2002-07-23 | Amei Technologies Inc. | High tibial osteotomy method and apparatus |
US6678562B1 (en) | 2000-01-12 | 2004-01-13 | Amei Technologies Inc. | Combined tissue/bone growth stimulator and external fixation device |
US20060111740A1 (en) * | 2000-06-07 | 2006-05-25 | Ai Asset Acquisition Company Llc | Method and apparatus for facilitating the healing of bone fractures |
US20080172106A1 (en) * | 2007-01-11 | 2008-07-17 | Mcginnis William J | Osteogenic stimulus device, kit and method of using thereof |
US20080171304A1 (en) * | 2007-01-11 | 2008-07-17 | Mcginnis William J | Dental implant kit and method of using same |
US20080172107A1 (en) * | 2007-01-11 | 2008-07-17 | Mcginnis William J | Stand alone osteogenic stimulus device and method of using |
US20090326602A1 (en) * | 2008-06-27 | 2009-12-31 | Arkady Glukhovsky | Treatment of indications using electrical stimulation |
US20100191247A1 (en) * | 2009-01-23 | 2010-07-29 | David James Schneider | Apparatus and method for arthroscopic transhumeral rotator cuff repair |
US20100292756A1 (en) * | 2009-05-12 | 2010-11-18 | Schneider David J | Bioelectric implant and method |
US8332029B2 (en) | 2005-06-28 | 2012-12-11 | Bioness Inc. | Implant system and method using implanted passive conductors for routing electrical current |
US8406886B2 (en) | 2004-01-22 | 2013-03-26 | Rehabtronics, Inc. | Method of routing electrical current to bodily tissues via implanted passive conductors |
US8483820B2 (en) | 2006-10-05 | 2013-07-09 | Bioness Inc. | System and method for percutaneous delivery of electrical stimulation to a target body tissue |
US20140350649A1 (en) * | 2005-06-03 | 2014-11-27 | Medrelief Inc. | Methods for modulating osteochondral development using bioelectrical stimulation |
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Publication number | Priority date | Publication date | Assignee | Title |
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DE69228531T2 (en) * | 1992-02-20 | 1999-07-29 | Neomedics, Inc., Budd Lake, N.J. | Implantable bone growth stimulator |
US5565005A (en) * | 1992-02-20 | 1996-10-15 | Amei Technologies Inc. | Implantable growth tissue stimulator and method operation |
US5458627A (en) * | 1992-10-15 | 1995-10-17 | Electro-Biology, Inc. | Electrochemically controlled faradic stimulation of osteogenesis |
US5524624A (en) * | 1994-05-05 | 1996-06-11 | Amei Technologies Inc. | Apparatus and method for stimulating tissue growth with ultrasound |
US5843741A (en) * | 1994-08-01 | 1998-12-01 | Massachusetts Insitute Of Technology | Method for altering the differentiation of anchorage dependent cells on an electrically conducting polymer |
US6493588B1 (en) * | 1998-03-18 | 2002-12-10 | Mmc/Gatx Partnership No. 1 | Electro-nerve stimulator systems and methods |
US8812114B2 (en) * | 2001-10-18 | 2014-08-19 | Uroplasty, Inc. | Lead set for nerve stimulator and method of operation thereof |
EP2308553B1 (en) * | 2001-10-18 | 2014-01-29 | Uroplasty, Inc. | Electro-nerve stimulator system |
US7206638B2 (en) * | 2002-11-20 | 2007-04-17 | The Nemours Foundation | Electrical current induced inhibition of bone growth |
CN101060815B (en) | 2004-06-07 | 2012-07-18 | 芯赛斯公司 | Orthopaedic implant with sensors |
US7668598B2 (en) | 2006-05-18 | 2010-02-23 | Uroplasty, Inc. | Method and apparatus for stimulating a nerve of a patient |
US10398148B2 (en) | 2008-01-03 | 2019-09-03 | Souhel Khanania | Oven |
US8201493B2 (en) | 2008-01-03 | 2012-06-19 | Souhel Khanania | Oven |
US8167114B2 (en) | 2008-01-03 | 2012-05-01 | Souhel Khanania | System and method for product removal |
TWI491267B (en) * | 2008-06-27 | 2015-07-01 | Chiun Mai Comm Systems Inc | Sound box structure of electronic device |
EP4257038A3 (en) | 2015-03-20 | 2023-11-15 | Intelligent Implants Limited | System for dynamically stimulating bone growth |
US10617880B2 (en) | 2015-12-08 | 2020-04-14 | Intelligent Implants Limited | System and method for an electrical implant device with increased patient compliance |
US11471297B2 (en) * | 2018-10-03 | 2022-10-18 | Intelligent Implants Limited | System and method to alter electrically stimulated bone growth through electrode selection |
US11844706B2 (en) | 2019-03-20 | 2023-12-19 | Grabango Co. | System and method for positioning and orienting an orthopedic implant |
WO2021084521A1 (en) | 2019-11-01 | 2021-05-06 | Intelligent Implants Limited | System and method for embedding electronic components within an implant |
Citations (11)
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US3842841A (en) * | 1971-10-29 | 1974-10-22 | Us Navy | Constant current power pack for bone healing and method of use |
US3848608A (en) * | 1973-07-23 | 1974-11-19 | Gen Electric | Subject integument spatial stimulator |
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US4430999A (en) * | 1981-11-10 | 1984-02-14 | Trustees Of The University Of Pennsylvania | Osteogenesis stimulating cathode assembly for use with an internal fixation device |
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US4620543A (en) * | 1984-06-15 | 1986-11-04 | Richards Medical Company | Enhanced fracture healing and muscle exercise through defined cycles of electric stimulation |
US4889111A (en) * | 1984-02-08 | 1989-12-26 | Ben Dov Meir | Bone growth stimulator |
-
1990
- 1990-07-02 US US07/547,821 patent/US5056518A/en not_active Ceased
-
1993
- 1993-10-15 US US08/138,230 patent/USRE35129E/en not_active Expired - Lifetime
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Non-Patent Citations (28)
Title |
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Baranowski, Thomas J. et al., "Microenvironmental Changes Associated With Electrical Stimulation of Osteogenesis by Direct Current", Trans. Bioelectrical Repair Growth Soc. 2:47 (1982). |
Baranowski, Thomas J. et al., "Mircroenvironmental Changes and Electrodic Potentials Associated With Electrical Stimulation of Osteogenesis by Direct Current," Trans. Orthop. Res. Soc. 8:258 2:47 (1983). |
Baranowski, Thomas J. et al., "The Mechanism of Faradic Stimulation of Osteogenesis," In: "Mechanistic Approaches to Interactions of Electric and Electromagnetic Fields with Living Systems," M. Blank and E. Findle, eds., Plenum Publishing Corp., New York, 399-416 (1987). |
Baranowski, Thomas J. et al., "The Role of Cathodic Potential in Electrical Stimulation of Osteogenesis by Direct Current" Trans. Orthop. Res. Soc. 8:352 (1983). |
Baranowski, Thomas J. et al., "The Role of Cathodic Potential in Electrical Stimulation of Osteogenesis by Direct Current," Trans. Bioelectrical Repair Growth Soc. 3:34 (1983). |
Baranowski, Thomas J. et al., Microenvironmental Changes Associated With Electrical Stimulation of Osteogenesis by Direct Current , Trans. Bioelectrical Repair Growth Soc. 2:47 (1982). * |
Baranowski, Thomas J. et al., Mircroenvironmental Changes and Electrodic Potentials Associated With Electrical Stimulation of Osteogenesis by Direct Current, Trans. Orthop. Res. Soc. 8:258 2:47 (1983). * |
Baranowski, Thomas J. et al., The Mechanism of Faradic Stimulation of Osteogenesis, In: Mechanistic Approaches to Interactions of Electric and Electromagnetic Fields with Living Systems, M. Blank and E. Findle, eds., Plenum Publishing Corp., New York, 399 416 (1987). * |
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Black, Jonathan et al., Electrochemical Aspects of d.c. Stimulation of Osteogenesis, Bioelectrochem. Bioenergetics 12:323 327 (1984). * |
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Brighton, C. T., Present and Future of Electrically Induced Osteogenesis, In: Clinical Trends In Orthopaedics Ed: Straub and Wilson, Jr., Thieme Stratton, N.Y., 1 15 (1982). * |
Brighton, Carl T. et al., "Cathodic Oxygen Consumption and Electrically Induced Osteogenesis," Clin. Orthop. Rel. Res. 107:277-282 (1975). |
Brighton, Carl T. et al., "Electrical Stimulation and Oxygen Tension," Annals N.Y. Acad. Sci. 238:314-320 (1974). |
Brighton, Carl T. et al., Cathodic Oxygen Consumption and Electrically Induced Osteogenesis, Clin. Orthop. Rel. Res. 107:277 282 (1975). * |
Brighton, Carl T. et al., Electrical Stimulation and Oxygen Tension, Annals N.Y. Acad. Sci. 238:314 320 (1974). * |
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Spadaro, Joseph A., "Bioelectrochemical studies of Implantable Bone Stimulation Electrodes," Bioelectrochem. Bioenergetics 5:232-238 (1978). |
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