WO1993000959A1 - Procede et appareil de traitement de tissus - Google Patents

Procede et appareil de traitement de tissus Download PDF

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Publication number
WO1993000959A1
WO1993000959A1 PCT/US1992/005587 US9205587W WO9300959A1 WO 1993000959 A1 WO1993000959 A1 WO 1993000959A1 US 9205587 W US9205587 W US 9205587W WO 9300959 A1 WO9300959 A1 WO 9300959A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrode device
tissue
electrode
treated
area
Prior art date
Application number
PCT/US1992/005587
Other languages
English (en)
Inventor
Bradford W. Baer
Original Assignee
Baer Bradford W
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Baer Bradford W filed Critical Baer Bradford W
Priority to EP9292915713A priority Critical patent/EP0600914A4/fr
Priority to JP5502332A priority patent/JPH06508783A/ja
Publication of WO1993000959A1 publication Critical patent/WO1993000959A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A61N1/0432—Anode and cathode
    • A61N1/044—Shape of the electrode

Definitions

  • This invention relates to a novel method and apparatus for treating tissue, including the application of an electric field to tissue surfaces as well as the delivery of topical drugs to an area of tissue to be treated using such electric field. More specifically, the invention relates to methods of delivering topical drugs, including proteins and nucleic acids, to skin by electrically stimulating the skin. Further, the invention relates to the transdermal delivery of electrical stimulation across the skin boundary to treat the underlying tissue. Such treatment can include the delivery of a drug or other compound to such tissue.
  • Iontophoresis is a well known .technique for delivering drugs through the skin which involves applying an electric potential gradient at the skin surface to enhance the permeability of the skin to the drug molecules.
  • Research has been conducted on iontophoretic transdermal delivery of peptide and protein drugs (Chien, Yie W., et al., (1989) J. of Pharm. Sci. 78. 376-383); nonpeptide drugs (Sanderson, et al., (1989) J. of Pharm. Sci. 78. 361-364); and polypeptide drugs (Srinivasan, V., et al., (1989) J. of Pharm. Sci. 78. 370-375).
  • Iontophoresis has proven effective for transdermal delivery of local anesthesia, metallic and nonmetallic ions, vasodilators, dermatological medications, and steroids (Behl, et al. (1989) J. of Pharm. Sci. 78. 355- 360).
  • One of the earliest uses of iontophoresis involved introducing a sweat-inducing drug through the skin to diagnose cystic fibrosis (Chien, Yie W., et al. (1989) J. of Pharm. Sci. 78. 353-354).
  • Other biomedical applications of iontophoresis include treatment for hyperhidrosis, edema formation, calcium deposits, and hay fever (Behl, et al., (1989) J. of Pharm. Sci. 78, 355-360).
  • An iontophoretic drug delivery system generally includes a power source, control circuitry, and two electrode pads.
  • One of the electrode pads contains a solution of an ionic drug and the other electrode pad contains an electrolyte.
  • the electrode pads are placed on the skin, and an electric current is supplied to the pads to induce an electric field at the skin surface.
  • the power supply is connected to the electrode pads so that the charge of the pole connected to the drug-containing electrode is the same as the charge of the ionic drug.
  • the application of an electric potential at the drug-containing electrode will drive the drug ions through the skin and into the body (Sanderson, John E. et al. (1987) J. of Pharm. Sci. 76. 215-218; Phipps, J. B., et al. (1989) J. of Pharm. Sci. 78. 365-369).
  • One such iontophoretic drug delivery system marketed by Iomed, Inc. under the trademark TransQl, includes a dispersive electrode and a drug delivery electrode.
  • the drug delivery electrode is mounted to a plastic holding tray which includes an absorbent pad for receiving the drug. Once the pad is fully hydrated with the drug, the drug delivery electrode and absorbent pad are separated from the holding tray and placed on the skin at the treatment site.
  • the dispersive electrode is placed on the skin spaced from the drug delivery electrode, and leads are attached to the pair of electrodes to generate an electric potential gradient at the treatment site.
  • This drug delivery system is primarily used to deliver a water soluble medication, such as a local anesthetic and/or corticosteroid, through a patient's skin. A disadvantage of this system is the excessive length of time required for treatment.
  • Rogaine (Minoxidil, 2% topical solution) is a topically applied drug, marketed by the Upjohn Company, which has proven effective in treating male pattern baldness involving the top, or vertex, of the head. Although Rogaine has successfully stimulated hair growth on the top of the head, no clinically significant effect has been seen in patients with predominantly frontal hair loss.
  • a preferred method of delivering topical drugs to the skin which is intended to accomphsh at least some of the foregoing objects includes the step of applying the drug to be delivered to one of an area of skin to be treated and an electrode device.
  • the drug is applied to the electrode device.
  • the electrode device which is formed to generate a multiplicity of simultaneous and directionally distinct electrical fields, is then placed in contact with the area of skin to be treated. Finally, voltage is delivered to the electrode device to generate simultaneous and directionally distinct electric fields at the skin surface.
  • Such methods and apparatus may be readily applied to similar treatment of other tissue surfaces. Further, such methods and apparatus may be readily adapted to apply unique electric fields to the surface of tissue and to tissue underlying such tissue surfaces to enhance circulation or the delivery of drugs to such tissue.
  • FIGURE 1 is a top plan view of an electrode device for use with the subject method of delivering topical drugs to the skin;
  • FIGURE 2 is an enlarged top view of a section of the electrode device of Figure 1; and FIGURES 3a-c are photographs of enhanced hair growth using the methods and apparatus of the invention.
  • FIGURE 1 Before describing the subject methods of applying novel electric fields and the delivery of drugs to a tissue surface or underlying tissue, it may be helpful to describe the electrode device for use with the subject method. Referring to the drawings, wherein like numerals indicate like parts, and initially to FIGURE 1, there will be seen an electrode device
  • substantially planar support member 12 composed of a substantially non-conductive material.
  • This device in general is made of a flexible planar support member to accommodate the contours of the tissue surface to be treated.
  • Suitable non-conductive materials for forming support member 12 include mica, polyester, and polystyrene.
  • Support member 12 has a main portion 14, preferably circular in shape, and a tab portion 16 extending from the perimeter of main portion 14. Tab portion 16 facilitates connection of lead lines to electrode device 10.
  • a first electrode pattern 18a and a second electrode pattern 18b are disposed on main portion 14 of electrode device 10.
  • First electrode pattern 18a and second electrode pattern 18b each include a set of substantially parallel electrodes 20a and 20b, respectively, which extend across main portion 14 in an alternating arrangement. Electrodes 20a and 20b are uniformly spaced across main portion 14 to ensure an even distribution of current density beneath electrode device 10, thereby reducing the likelihood of skin burns.
  • a pair of electrode leads 22a and 22b extend along opposite sides of tab portion 16 and halfway around the perimeter of main portion 14. Electrodes 20a are electrically coupled together by electrode lead 22a, and electrodes 20b are electrically interconnected by electrode lead 22b. Each set of electrodes 20a and 20b are electrically connected to one another so that a voltage applied to the corresponding electrode leads 22a and 22b is uniformly distributed across each of the electrodes.
  • first and second electrode patterns 18a and 18b respectively, generates multiple directionally distinct electrical fields when opposite charges are applied to electrode leads 22a and 22b.
  • the arrows represent electric field lines generated by connecting lead lines of opposite polarity to electrode leads 22a and 22b.
  • support member 12 may be fabricated in different shapes according to the area of tissue to be treated and according to the specific medical application.
  • Electrode patterns may be formed by screen printing a conductive ink on support member 12.
  • a technique for printing a conductive ink on a flexible substrate is disclosed by M. Martel in "The Basics of Area Source IR", SITE Magazine, pgs. 60-64.
  • Suitable conductive inks for forming the electrode patterns of the subject invention include E-1400 ink marketed by Ercon Incorporated and Electrodag
  • the electrode patterns may be formed by selectively depositing a metallic material, such as aluminum, on main portion 14.
  • the electrode patterns may be formed by using a masking technique to deposit copper vapor or other metallic vapor such as aluminum, gold, platinum, and nickel, on main portion 14.
  • E SHEET The methods used to produce such vapor deposited electrode devices and selectively etched electrode devices are well known. Metal deposition may be carried out according to the methods disclosed by P. Gise and R. Blanchard in "Modern Semiconductor Fabrication
  • the electrode material preferably ranges in thickness from approximately .001 inches to 1 inch.
  • Each electrode has a width of approximately lO ⁇ m to 2mm, preferably between 0.1mm and 1mm.
  • the spacing between the electrodes ranges from approximately lO ⁇ m to 2mm, preferably 0.1mm to 1mm.
  • first and second electrode leads 22a and 22b may be applied across first and second electrode leads 22a and 22b to generate an appropriate voltage gradient or sufficient electrical current.
  • 10 to 100 volts DC are applied across electrode leads 22a and 22b; however, the applied voltage may range from approximately 1 to 500 volts DC. It is preferable to deliver a pulsed voltage, as opposed to a continuous voltage, to electrode device 10 to prevent the build-up of charge on the skin.
  • Tissue includes but is not
  • SUBSTITUTE SHEET limited to skin, tendons, muscles, nerves, internal organs and tissues of the oral cavity.
  • the drug is applied to a localized area of skin to ensure even distribution of the drug across the skin surface. If the drug is applied directly to electrode device 10, the drug should be spread evenly across the surface of device 10 on which electrode patterns 18a and 18b are disposed, or the conductive surface of device 10. Once the drug has been applied, the conductive surface of device 10 is placed in contact with the area of skin to be treated. A voltage is then applied across electrode leads 22a and 22b to generate simultaneous and directionally distinct electric fields between electrodes 20a and 20b. The electric fields electrically stimulate the area of skin being treated.
  • the subject method of the invention may be used in combination with the topical hair growth drug Rogaine, commercially marketed by The Upjohn Company.
  • Rogaine has only been successful in promoting hair growth on the vertex of the head.
  • Rogaine has been shown to stimulate hair growth on the front of the scalp.
  • a user applies a full dose of Rogaine, specifically lmL, to the front of the scalp per the directions found in the literature accompanying a Rogaine prescription. After the full dose has been applied to the user's scalp with the supplied rub-
  • the user places the conductive surface of electrode device 10 in contact with the area of the scalp to be treated.
  • the user then turns on the power supply to electrode device 10 which is preferably set to deliver approximately fifty to one hundred 100 volt DC pulses of 1 ampere of current over a period of 15 to 30 seconds, each pulse lasting approximately 1 to 10 msec.
  • the user may move electrode device 10 over the area of skin being treated.
  • the user may selectively apply pressure to electrode device 10 to adjust the contact of electrode device 10 with the skin.
  • the user may feel a sensation of mild tingling. After approximately four months of treatment, hair growth becomes apparent. This was repeated twice daily over 60 days.
  • FIGURES 3a-c The results of applying Rogaine to the frontal lobe of the scalp and treating the scalp with the electrode device as described above over a 60 day period are shown in FIGURES 3a-c.
  • FIGURE 3a shows the condition of the scalp on day 0 prior to the start of the experiment.
  • FIGURES 3b and 3c show the same scalp after 20 and 60 days, respectively.
  • the right side of the scalp (left side in the figures) is the area treated with Rogaine and the electrode device 10.
  • the left side of the scalp (right side in the figures) is the control area, i.e., treated only with Rogaine.
  • FIGURE 3b new hair growth is seen at 20 days.
  • FIGURE 3c hair growth after just 60 days was substantial.
  • the subject electrode device 10 may also be used in combination with other topical drugs to treat a variety of skin maladies including: (i) Retin A (Tretinoin, all, trans Retinoic Acid), commercially marketed by Ortho
  • compositions for treatment of brown spots, acne, and wrinkles, (ii) steroids to treat inflammation and psoriasis, (iii) topical pain relievers for treatment of aberrations of the skin and underlying tissue, and (iv) 5-fluorouracil to treat skin cancer and psoriasis.
  • electrode device 10 may also be used without an accompanying topical drug. Electrical stimulation alone has therapeutic and diagnostic value. Electrode device 10 may be used to electrically stimulate the skin of a user to, for example, increase blood flow, induce secretions, and stimulate nerves.
  • tests were performed where the electrode device 10 was applied to the inner forearm area of a human.
  • the same protocol as previously described was used except no topical drug was applied to the skin or electrode device 10.
  • the test produced a region of redness indicating increased circulation to the area.
  • the increased circulation is useful for enhancing the delivery of drugs to the localized skin area which are administered IV or orally.
  • An advantage of using the apparatus and method of the invention lies in the fact that treatment can be effected without significant discomfort of tissue damage (even after twice daily treatment for almost six months).
  • the only feeling sensed by the user is a mere tingling of the scalp which is believed to be evidence of subcutaneous nerve stimulation.
  • Electrode device 10 may also provide gene therapy to skin or other tissue by transfecting nucleic acid into the cells of the skin or tissue or cells underlying such surfaces for treating gene deficiencies or inducing such deficiencies in laboratory animals.
  • Nucleic acids which may be used for transfection include DNA capable of expressing an antisense RNA transcript which is capable of down modulating translation of endogenous RNA transcripts.
  • Proteinaceous gene products may also be delivered to the skin cells by the subject method. Such proteins include Factor VIII, insulin, and adenosine deaminase.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)
  • General Preparation And Processing Of Foods (AREA)

Abstract

Procédé d'apport de médicaments topiques à des tissus, consistant à appliquer ledit médicament sur une zone de tissus à traiter et à utiliser un dispositif à électrodes (10). Ledit dispositif à électrodes, qui est conçu pour produire une multiplicité de champs électriques simultanés et directionnellement distincts, est ensuite mis en contact avec la zone de tissus à traiter. Le dispositif à électrode est alors mis sous tension de manière à produire des champs électriques simultanés et directionnellement distincts à la surface des tissus.
PCT/US1992/005587 1991-07-03 1992-07-02 Procede et appareil de traitement de tissus WO1993000959A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP9292915713A EP0600914A4 (fr) 1991-07-03 1992-07-02 Procede et appareil de traitement de tissus.
JP5502332A JPH06508783A (ja) 1991-07-03 1992-07-02 組織を治療する方法及びその装置

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US72527991A 1991-07-03 1991-07-03
US725,279 1991-07-03

Publications (1)

Publication Number Publication Date
WO1993000959A1 true WO1993000959A1 (fr) 1993-01-21

Family

ID=24913891

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1992/005587 WO1993000959A1 (fr) 1991-07-03 1992-07-02 Procede et appareil de traitement de tissus

Country Status (6)

Country Link
EP (1) EP0600914A4 (fr)
JP (1) JPH06508783A (fr)
AU (1) AU2336992A (fr)
CA (1) CA2112366A1 (fr)
IL (1) IL102406A0 (fr)
WO (1) WO1993000959A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003061757A1 (fr) * 2002-01-24 2003-07-31 Hisamitsu Pharmaceutical Co., Inc. Preparations transdermiques/transmuqueuses pour electroporation
WO2005068016A1 (fr) * 2004-01-15 2005-07-28 Power Paper Ltd Timbre transdermique pour iontophorese
US7476222B2 (en) 2003-06-30 2009-01-13 Johnson & Johnson Consumer Companies, Inc. Methods of reducing the appearance of pigmentation with galvanic generated electricity
WO2010088914A1 (fr) * 2009-02-05 2010-08-12 Aalborg Universitet Dispositif de régulation du débit sanguin sous-cutané
US8239017B2 (en) 2003-06-30 2012-08-07 Johnson & Johnson Consumer Companies, Inc. Device for treatment of barrier membranes
US8734421B2 (en) 2003-06-30 2014-05-27 Johnson & Johnson Consumer Companies, Inc. Methods of treating pores on the skin with electricity
US9044397B2 (en) 2009-03-27 2015-06-02 Ethicon, Inc. Medical devices with galvanic particulates
US9566431B2 (en) 2014-04-07 2017-02-14 Pilogics L.P. Method of forming a large number of metal-ion-deposition islands on the scalp by a rapid series of brief electrode-contact events
US11110272B2 (en) 2011-12-08 2021-09-07 Pilogics L.P. Apparatus for stimulating hair growth and/or preventing hair loss

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4164226A (en) * 1976-08-25 1979-08-14 Robert Tapper Iontophoretic burn-protection electrode structure
GB2132892A (en) * 1983-01-10 1984-07-18 Hayashibara Ken Device for stimulating growth and regeneration of hair
US4736752A (en) * 1986-11-28 1988-04-12 Axelgaard Manufacturing Co., Ltd. Transcutaneous medical electrode
DE3736072A1 (de) * 1987-09-24 1989-04-13 Soft Electrics & Cosmetics Ver Verfahren und geraet zur foerderung des wohlbefindens des menschen und zur kosmetischen behandlung der haut
US5002527A (en) * 1988-04-14 1991-03-26 Inventor's Funding Corp. Ltd. Transdermal drug delivery applicators

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2322615A1 (fr) * 1975-09-02 1977-04-01 Le Goaster Jacqueline Procede d'application cutanee en vue d'une penetration sous-cutanee de divers produits et produit pour sa mise en oeuvre
WO1990006153A1 (fr) * 1988-11-28 1990-06-14 Innofinance Általános Innovációs Pénzintézet Rt. Appareil d'iontophorese

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4164226A (en) * 1976-08-25 1979-08-14 Robert Tapper Iontophoretic burn-protection electrode structure
GB2132892A (en) * 1983-01-10 1984-07-18 Hayashibara Ken Device for stimulating growth and regeneration of hair
US4736752A (en) * 1986-11-28 1988-04-12 Axelgaard Manufacturing Co., Ltd. Transcutaneous medical electrode
DE3736072A1 (de) * 1987-09-24 1989-04-13 Soft Electrics & Cosmetics Ver Verfahren und geraet zur foerderung des wohlbefindens des menschen und zur kosmetischen behandlung der haut
US5002527A (en) * 1988-04-14 1991-03-26 Inventor's Funding Corp. Ltd. Transdermal drug delivery applicators

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0600914A4 *

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7643874B2 (en) 2001-10-24 2010-01-05 Power Paper Ltd. Dermal patch
WO2003061757A1 (fr) * 2002-01-24 2003-07-31 Hisamitsu Pharmaceutical Co., Inc. Preparations transdermiques/transmuqueuses pour electroporation
US7476222B2 (en) 2003-06-30 2009-01-13 Johnson & Johnson Consumer Companies, Inc. Methods of reducing the appearance of pigmentation with galvanic generated electricity
US8239017B2 (en) 2003-06-30 2012-08-07 Johnson & Johnson Consumer Companies, Inc. Device for treatment of barrier membranes
US8734421B2 (en) 2003-06-30 2014-05-27 Johnson & Johnson Consumer Companies, Inc. Methods of treating pores on the skin with electricity
WO2005068016A1 (fr) * 2004-01-15 2005-07-28 Power Paper Ltd Timbre transdermique pour iontophorese
WO2010088914A1 (fr) * 2009-02-05 2010-08-12 Aalborg Universitet Dispositif de régulation du débit sanguin sous-cutané
US9044397B2 (en) 2009-03-27 2015-06-02 Ethicon, Inc. Medical devices with galvanic particulates
US11110272B2 (en) 2011-12-08 2021-09-07 Pilogics L.P. Apparatus for stimulating hair growth and/or preventing hair loss
US9566431B2 (en) 2014-04-07 2017-02-14 Pilogics L.P. Method of forming a large number of metal-ion-deposition islands on the scalp by a rapid series of brief electrode-contact events

Also Published As

Publication number Publication date
IL102406A0 (en) 1993-01-14
EP0600914A1 (fr) 1994-06-15
JPH06508783A (ja) 1994-10-06
AU2336992A (en) 1993-02-11
CA2112366A1 (fr) 1993-01-21
EP0600914A4 (fr) 1994-11-02

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