EP0968029A1 - Method for measuring the cutaneous electric resistance of a patient subjected to transdermal administration of medicine - Google Patents
Method for measuring the cutaneous electric resistance of a patient subjected to transdermal administration of medicineInfo
- Publication number
- EP0968029A1 EP0968029A1 EP97947082A EP97947082A EP0968029A1 EP 0968029 A1 EP0968029 A1 EP 0968029A1 EP 97947082 A EP97947082 A EP 97947082A EP 97947082 A EP97947082 A EP 97947082A EP 0968029 A1 EP0968029 A1 EP 0968029A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- skin
- patient
- current
- administration
- measurement
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
- A61B5/053—Measuring electrical impedance or conductance of a portion of the body
- A61B5/0531—Measuring skin impedance
-
- 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
- A61N1/30—Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
Definitions
- the present invention relates to a method for measuring the electrical cutaneous resistance of a patient and, more particularly, to such a method implemented on a patient subjected to a transdermal administration of medicaments assisted by an iontophoretic current.
- This monitoring is commonly carried out via that of the electrical resistance of the patient's skin, it being noted that a modification of the structure thereof, due to the imminent appearance of a lesion, manifests itself by a variation of said cutaneous electrical resistance.
- the electrical voltage present between the electrodes pressed against the patient's skin is noted at the time of the measurement.
- These electrodes are part of a device for transdermal administration assisted by iontophoresis, which comprises means for adjusting the iontophoretic current.
- this tension measurement also makes it possible to diagnose the occurrence of defective functioning of the device, such as for example a short circuit of the skin by sweat spread over this skin, insufficient hydration of a reservoir of active ingredient attached to an electrode, etc, etc, ...
- the object of the present invention is precisely to provide a method for measuring the cutaneous electrical resistance of a patient subjected to a transdermal administration of drug assisted by iontophoresis, which makes it possible to safely diagnose the imminence of the appearance of such a lesion.
- the present invention also aims to provide such a method which also makes it possible to diagnose the occurrence or the existence of malfunctions of the device used for ensuring the transdermal administration of the drug assisted by iontophoresis.
- a value corresponding to a substantially zero flow of the drug through the patient's skin is chosen for said predetermined value of the iontophoretic current.
- - Figure 2 is a flowchart illustrating an embodiment of the measurement method according to the invention
- - Figure 3 is a flowchart illustrating the use made of the measurements obtained by the method according to the invention.
- FIG. 1 of the appended drawing in which it appears that the current / voltage characteristic of the skin of a human being has a rectilinear part OA on the side of the origin 0, and a curvilinear part AB, the threshold A separating these parts typically corresponding to a current intensity of 200 ⁇ A, measured between two neighboring electrodes with a surface area of 4 cm 2 each, which corresponds to a current density of 50 ⁇ A / cm 2 .
- this observation is used to make the tension measurement aimed at achieving the cutaneous resistance of the skin independent of the non-linearity of the part AB.
- the iontophoretic current is adjusted to a value I m situated in the range of variation corresponding to the rectilinear part OA, ie in the range O-200 ⁇ A.
- I m situated in the range of variation corresponding to the rectilinear part OA, ie in the range O-200 ⁇ A.
- the difference ⁇ V of the voltages measured on these two curves is exactly representative of the only variation in slope of the right part of the characteristic, this slope corresponding precisely to the desired resistance of the skin in the intensity range O-200 ⁇ A, i.e. 0-50 ⁇ A / cm 2 . This would not be the case if we had placed sacred in the non-linear part of the characteristic.
- the slope variation is measured with reference to the slope of the OA segment of the OAB characteristic corresponding to healthy skin.
- the measured voltage variation is perfectly representative of the change in the structure of the skin over time, resulting from the application of an iontophoretic current to initially healthy skin. It is thus possible to detect the imminence of a state of degradation of the skin, edema, burning or the like, which one does not wish to reach, and to stop the transdermal treatment before the occurrence of this state. This prevents both an unbearable deterioration of the patient's skin and a prolongation of the treatment on degraded skin, not allowing a correct execution of this treatment.
- the execution of this process can take place before the start of a treatment, to verify that the condition of the patient's skin and that of the transdermal delivery device used are suitable to such administration, as will be explained below in connection with FIG. 3.
- the execution of the method can also take place during the duration of the treatment, for example at regular intervals, so as to monitor these same states and to decide to continuation or cessation of treatment depending on the diagnosed conditions.
- the electronics of the administration device is programmed to reduce the intensity XmA of the iontophoretic current which it delivers (for example 500 ⁇ A) at the level I m indicated above, located in the rectilinear part OA of the characteristic of FIG. 1, this level being sufficiently low to create no sensitive ionophoretic flux liable to disturb the measurement to be carried out.
- this intensity level I m or "measurement current” can thus be fixed at 50 ⁇ A (or 12.5 uA / cm 2 ) for example (step a, FIG. 2).
- the device After having established and maintained this current for a certain time, for example 3 seconds, to allow stabilization of the measurement to be operated and possible depolarization of the skin, the device reads (step b) the voltage V skin prevailing between the applied electrodes on the patient's skin and calculates (step c) the cutaneous resistance R cut by applying Ohm's law:
- the iontophoretic or "therapeutic" current is gradually restored between the electrodes up to the previous XmA level.
- step d we can, for example, set XmA / 4, then 2XmA / 4, 3XmA / 4, each time for 1 second, before returning to XmA.
- other current growth patterns could be used in place of it, in since they prevent a sudden return to the XmA level from causing an unpleasant sensation to the patient, before returning to therapeutic treatment.
- the measurement method described above can be implemented both during a time of application of the therapeutic current XmA and during times when this current is zero, which makes it possible to continuously monitor the state of the device and the skin. So sweating of this skin can then be detected as well as the short circuit of the electrodes that it can cause.
- the measurements carried out when the therapeutic current is zero benefit from good precision, in particular when the measurement takes place at the end of such a period. Indeed, the measurement is then not disturbed by the polarization of the skin, a depolarization time of the latter having been provided before the measurement.
- the execution of the measurement method according to the invention can be triggered and controlled automatically by the electronics of the transdermal application device used.
- the measurement can be triggered at predetermined regular time intervals, for example.
- the duration of the interval can be chosen in the 20s-15mn range. It is preferable to choose an interval of 3 min.
- the electronics are programmed to compare (step e) the measured value R cu t of the skin resistance with a threshold value R m i n .
- This threshold can be adjusted between 100 and 1000 ohms, typically 500 ohms, when operating with electrodes with a surface area of 4 cm 2 . If Rcut is smaller than R m in and the measurement of R cu t takes place before the start of treatment, a visual and / or audible alarm is issued (step b) to the patient to warn him of its existence probable of a short circuit between the electrodes of the device, likely to prevent correct administration of the treatment. The start of treatment is then prohibited (step c). If this situation is detected during treatment, it is stopped.
- R cu t is greater than R m in
- the electronics of the device compares R cut with another threshold value R m a x (step d) which can be chosen between 50 kohms and 300 kohms, typically 100 kohms.
- R C ut is greater than R m a x this situation is signaled to the patient by an audible and / or visual alarm (step e) and the start or continuation of the treatment is prohibited (step f). Indeed, this situation can result from an alteration of the structure of the skin likely to lead, in an imminent manner, to a lesion of the type of those mentioned above. It can also result from a defect in the transdermal delivery device itself.
- the thresholds R m i n and R m a can be adjusted at different levels for measurements occurring before treatment and during treatment, respectively, so that the detections of defects or lesions are then carried out with different sensitivities .
- the invention is not limited to the administration of such major analgesics and extends, on the contrary, to others: morphine, bupremorphine and derivatives, or even to any active principle capable of being administered transdermally under iontophoretic assistance.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Physics & Mathematics (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Pathology (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Electrotherapy Devices (AREA)
Abstract
Description
Claims
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR9614088A FR2755842B1 (en) | 1996-11-19 | 1996-11-19 | METHOD FOR MEASURING THE SKIN RESISTANCE OF A PATIENT SUBJECT TO A TRANSDERMAL ADMINISTRATION OF MEDICAMENT |
FR9614088 | 1996-11-19 | ||
PCT/FR1997/002072 WO1998022182A1 (en) | 1996-11-19 | 1997-11-18 | Method for measuring the cutaneous electric resistance of a patient subjected to transdermal administration of medicine |
US09/312,498 US6391015B1 (en) | 1996-11-19 | 1999-05-17 | Method for measuring the cutaneous electrical resistance of a patient subjected to transdermal administration of medicine |
Publications (1)
Publication Number | Publication Date |
---|---|
EP0968029A1 true EP0968029A1 (en) | 2000-01-05 |
Family
ID=26233107
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP97947082A Withdrawn EP0968029A1 (en) | 1996-11-19 | 1997-11-18 | Method for measuring the cutaneous electric resistance of a patient subjected to transdermal administration of medicine |
Country Status (6)
Country | Link |
---|---|
US (1) | US6391015B1 (en) |
EP (1) | EP0968029A1 (en) |
JP (1) | JP2001505098A (en) |
AU (1) | AU5226098A (en) |
FR (1) | FR2755842B1 (en) |
WO (1) | WO1998022182A1 (en) |
Families Citing this family (25)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IE960312A1 (en) * | 1995-06-02 | 1996-12-11 | Alza Corp | An electrotransport delivery device with voltage boosting¹circuit |
US6047208A (en) * | 1997-08-27 | 2000-04-04 | Becton, Dickinson And Company | Iontophoretic controller |
US6385488B1 (en) | 1999-05-20 | 2002-05-07 | Vyteris, Inc. | Circuits for increasing the reliability of an iontophoretic system |
US6823212B2 (en) | 2001-06-13 | 2004-11-23 | The Procter & Gamble Company | Method and apparatus for measuring properties of a target surface |
JP2006334164A (en) * | 2005-06-02 | 2006-12-14 | Transcutaneous Technologies Inc | Iontophoresis apparatus and method for controlling the same |
JP2007000342A (en) * | 2005-06-23 | 2007-01-11 | Transcutaneous Technologies Inc | Iontophoresis device for controlling quantity and time of dosing a plurality of medicaments |
US20070088331A1 (en) * | 2005-08-18 | 2007-04-19 | Transcutaneous Technologies Inc. | Method and apparatus for managing active agent usage, and active agent injecting device |
EP1928542A1 (en) * | 2005-09-30 | 2008-06-11 | Tti Ellebeau, Inc. | Method and system to detect malfunctions in an iontophoresis device that delivers active agents to biological interfaces |
US20070078445A1 (en) * | 2005-09-30 | 2007-04-05 | Curt Malloy | Synchronization apparatus and method for iontophoresis device to deliver active agents to biological interfaces |
US20070135754A1 (en) * | 2005-09-30 | 2007-06-14 | Hidero Akiyama | Electrode assembly for iontophoresis for administering active agent enclosed in nanoparticle and iontophoresis device using the same |
WO2007079189A2 (en) * | 2005-12-30 | 2007-07-12 | Tti Ellebeau, Inc. | System and method for remote based control of an iontophoresis device |
US20080077076A1 (en) * | 2006-08-29 | 2008-03-27 | Transcutaneous Technologies Inc. | Iontophoresis device and method for operation with a usb (universal serial bus) power source |
EP2063863A2 (en) * | 2006-08-29 | 2009-06-03 | Alza Corporation | Drug electrotransport with hydration measurement of hydratable reservoir |
EP2061553A2 (en) * | 2006-09-05 | 2009-05-27 | Tti Ellebeau, Inc. | Impedance systems, devices and methods for evaluating iontophoretic properties of compounds |
BRPI0716452A2 (en) * | 2006-09-05 | 2014-03-04 | Tti Ellebeau Inc | NON-DESTRUCTIVE SYSTEMS, DEVICES, AND METHODS FOR EVALUATING IONTOPHORESIS MEDICINAL PRODUCTS DEVICES |
US8728059B2 (en) * | 2006-09-29 | 2014-05-20 | Covidien Lp | System and method for assuring validity of monitoring parameter in combination with a therapeutic device |
JP5383497B2 (en) | 2006-12-01 | 2014-01-08 | Tti・エルビュー株式会社 | System and device for powering and / or controlling a device, for example a transdermal delivery device |
WO2008087884A1 (en) * | 2007-01-16 | 2008-07-24 | Tti Ellebeau, Inc. | Method for predicting medicament dose and program therefor |
EP2307546A1 (en) * | 2008-06-04 | 2011-04-13 | Coda Therapeutics, Inc. | Treatment of pain with gap junction modulation compounds |
AU2010217957B2 (en) | 2009-02-26 | 2015-08-13 | Liquidia Technologies, Inc. | Interventional drug delivery system and associated methods |
WO2013148736A1 (en) | 2012-03-27 | 2013-10-03 | Coda Therapeutics, Inc. | Compositions and treatments based on cadherin modulation |
NZ701949A (en) | 2012-05-18 | 2016-07-29 | Otago Innovation Ltd | Combination treatments and compositions for wound healing |
FI127226B (en) * | 2013-12-20 | 2018-01-31 | Teknologian Tutkimuskeskus Vtt Oy | METHOD AND APPARATUS FOR SKIN TREATMENT |
AU2016202751B2 (en) * | 2015-04-30 | 2019-11-07 | Richard Malter | Iontophoresis device and method of treatment |
US10842979B1 (en) * | 2016-07-28 | 2020-11-24 | Bioelectric Devices, Inc. | Intelligent bioelectric module for use with drug delivery system |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2316326A1 (en) * | 1972-05-08 | 1973-11-29 | Siepem Fa | COMBINED DEVICE FOR HAIR HYGIENE AND FACIAL CARE |
US4141359A (en) * | 1976-08-16 | 1979-02-27 | University Of Utah | Epidermal iontophoresis device |
DE68925030T2 (en) * | 1988-01-21 | 1996-07-25 | Massachusetts Inst Technology | MOLECULE TRANSPORT THROUGH FABRICS WITH THE USE OF ELECTROPORATION. |
DE4028125A1 (en) * | 1990-01-17 | 1991-07-18 | Klimke Markus | Application plaster for regulated dosing of various pharmacons - uses electrical correct for percutaneous transport for local and systematic therapy |
FR2688106B1 (en) | 1992-02-27 | 1994-09-09 | Lhd Lab Hygiene Dietetique | DEVICE FOR GENERATING AN PREDETERMINED WAVEFORM ELECTRIC VOLTAGE, IONOPHORETIC APPARATUS FOR TRANSDERMAL DELIVERY OF MEDICAMENTS. |
US5499967A (en) | 1992-02-27 | 1996-03-19 | Societe Anonyme Dite: Laboratoires D'hygiene Societe Anonyme Dite: Et De Dietetique (L.H.D.) | Transdermal drug delivery device with waveshape generator |
US5533971A (en) * | 1993-09-03 | 1996-07-09 | Alza Corporation | Reduction of skin irritation during electrotransport |
CA2229872C (en) * | 1995-08-31 | 2002-02-05 | Hisamitsu Pharmaceutical Co., Inc. | Iontophoresis system and its control process of current |
-
1996
- 1996-11-19 FR FR9614088A patent/FR2755842B1/en not_active Expired - Fee Related
-
1997
- 1997-11-18 AU AU52260/98A patent/AU5226098A/en not_active Abandoned
- 1997-11-18 EP EP97947082A patent/EP0968029A1/en not_active Withdrawn
- 1997-11-18 WO PCT/FR1997/002072 patent/WO1998022182A1/en not_active Application Discontinuation
- 1997-11-18 JP JP52328198A patent/JP2001505098A/en active Pending
-
1999
- 1999-05-17 US US09/312,498 patent/US6391015B1/en not_active Expired - Fee Related
Non-Patent Citations (1)
Title |
---|
See references of WO9822182A1 * |
Also Published As
Publication number | Publication date |
---|---|
JP2001505098A (en) | 2001-04-17 |
FR2755842A1 (en) | 1998-05-22 |
FR2755842B1 (en) | 1999-04-23 |
AU5226098A (en) | 1998-06-10 |
WO1998022182A1 (en) | 1998-05-28 |
US6391015B1 (en) | 2002-05-21 |
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