WO2009130258A1 - Dispositif d'électroporation - Google Patents

Dispositif d'électroporation Download PDF

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Publication number
WO2009130258A1
WO2009130258A1 PCT/EP2009/054852 EP2009054852W WO2009130258A1 WO 2009130258 A1 WO2009130258 A1 WO 2009130258A1 EP 2009054852 W EP2009054852 W EP 2009054852W WO 2009130258 A1 WO2009130258 A1 WO 2009130258A1
Authority
WO
WIPO (PCT)
Prior art keywords
pins
handheld device
transmitter
head
ground
Prior art date
Application number
PCT/EP2009/054852
Other languages
English (en)
Inventor
Giuseppe Caccia
Original Assignee
Giuseppe Caccia
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 Giuseppe Caccia filed Critical Giuseppe Caccia
Publication of WO2009130258A1 publication Critical patent/WO2009130258A1/fr

Links

Classifications

    • 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
    • A61N1/327—Applying electric currents by contact electrodes alternating or intermittent currents for enhancing the absorption properties of tissue, e.g. by electroporation
    • 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
    • A61N1/0412—Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
    • A61N1/0416—Anode and cathode
    • A61N1/0424—Shape of the electrode
    • 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
    • A61N1/0472—Structure-related aspects
    • A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)

Definitions

  • the present invention relates to a device for delivering pharmacological and/or natural and/or cosmetic products by electroporation into skin layers of limited thickness.
  • the present invention relates in particular to a handheld device for delivering pharmacological and/or natural and/or cosmetic products by creating local electrical flux in skin layers of limited thickness.
  • Transdermal delivery of products can be achieved with ionophoresis systems.
  • ionophoresis systems only achieve penetration after twenty minutes of treatment, and have the drawback of causing abnormal electrolysis and reddening.
  • the application handheld devices are connected to electronic circuits generating electrical pulses whose amplitude and frequency are specific to the electroporation operation.
  • the handheld devices are designed to be applied to and moved over the areas to be treated, interposing the pharmacological and/or natural and/or cosmetic products which are to be delivered between each handheld device's head and the skin.
  • the ground plates serve to close the electronic circuits generating the pulses, and must be applied to the skin on the side opposite the treated side. For example, the ground plate must be applied to the lower abdomen when the buttocks are being treated.
  • the waveform emitted by the applicators at a predetermined frequency opens the interstitial channels very rapidly, in a few seconds, without causing electrolysis.
  • the active principles are delivered through the interstitial channels. These means can be used efficiently when the ground plates are easily placed opposite the handheld devices, and when the penetration of the transdermal delivery does not give rise to problems or contraindications.
  • the pharmacological and/or natural and/or cosmetic product is delivered not only into the scalp, but also through the cranium. In other words, the depth of transdermal penetration cannot be controlled. In the best case, most of the pharmacological and/or natural and/or cosmetic product would still accumulate in the scalp without reaching the cranium, but there is a possibility that at least some of the delivered product or products would penetrate into the cranium, in unknown quantities, densities and areas.
  • An aim of the present invention is thus to provide a device for efficiently delivering pharmacological and/or natural and/or cosmetic products by electroporation into skin layers of limited thickness.
  • Another aim of the invention is to provide a device for delivering pharmacological and/or natural and/or cosmetic products by electroporation into skin layers of limited thickness allowing for a control of the depth of penetration of the applied products.
  • a handheld device for delivering pharmacological and/or natural and/or cosmetic products by electroporation into skin layers of limited thickness comprising a head, a plurality of transmitter pins made from electrically conductive material projecting from the head, wherein the transmitter pins are electrically isolated from the head and electrically connected to an electroporation wave generator, and a plurality of ground pins made from electrically conductive material projecting from the head, wherein the ground pins are electrically isolated from the head and from said transmitter pins and electrically connected to the ground.
  • the handheld device of the invention thus allows delivering pharmacological and/or natural and/or cosmetic products directly into skin layers of limited thickness, for example the layer between the surface of the scalp and the bases of the underlying hair follicles, by a fast and painless process, without the products penetrating farther than necessary, i.e. devising a form of topical treatment which is to be applied directly to a skin surface and which provides controlled penetration of the products, to a depth of one or two millimetres for example.
  • the control of the depth of penetration is controlled thanks to the fact that transmitter pins and ground pins are located next to each other on the device's head. The electrical fluxes generated between these pins when the wave generator is switched on are thus local and only penetrate into a limited thickness of the skin of the user to which the device is applied.
  • the present invention thus provides a transdermal delivery device (of the type known as "electroporation") which can operate within the aforesaid penetration limits.
  • the present invention provides an electroporation system with a special handheld applicator device which has been devised for the purpose of transdermal delivery limited to delivery into the first layers of skin, to a depth of a few millimetres, so that, in the example relating to hair regeneration, the delivery extends to the base of the hair follicles and no farther.
  • Fig. 1 shows the general electrical circuit of the handheld device according to a preferred embodiment of the invention
  • Fig. 2 shows a diagram of the electroporation current flows generated by the device of Fig. 1 .
  • Fig. 3 illustrates an example of the construction of the electroporation handheld device of the invention, in a partially cut side view and in a plan view from below.
  • the handheld device of the invention for delivering pharmacological and/or natural and/or cosmetic products by electroporation into skin layers of limited thickness S comprises a head 1 , for example an interchangeable head, made from non-conductive material, with a hand grip 1 '.
  • the pins 2, 3 are divided into two groups which are electrically insulated from each other.
  • the pins 2 of the first group are connected through an electrical conductor 4 to a wave generator 5 and the pins 3 of the second group are connected through another electrical conductor 6 to the electrical ground 7.
  • the pins 2 of the first group are thus called transmitter pins 2, while the pins 3 of the second group are called ground pins 3.
  • the wave generator 5 is preferably controlled by a power supply, operation and control circuit board 8.
  • the power is either supplied from an embedded power supply such as a battery for example, or from an external power supply through a power cord.
  • the pins 2, 3 are aligned in the following sequence: transmitter pin 2 - ground pin 3 - transmitter pin 2 - ground pin 3, etc., in any required number, preferably according to the specific application of the handheld device to specific treatment areas.
  • the spacing between a transmitter pin 2 and a neighbouring ground pin 3 determines the depth of penetration of the products to be delivered transdermally.
  • the wave generator 5 When the wave generator 5 is switched on, electrical pulses of a determined shape and intensity are sent to the transmitter pins 2, thus generating current fluxes T between each transmitter pin 2 and its neighbouring ground pin or ground pins 3.
  • the current fluxes T penetrate into the skin S by a depth which depends on the intensity of the fluxes T and on the spacing of the transmitter and ground pins.
  • the penetration depth of the products applied to the skin S is thus increased or decreased by providing heads 1 with transmitter pins 2 and ground pins 3 which are closer to or farther from each other, thus producing current fluxes T which are larger or smaller and therefore penetrate deeper or shallower into the skin S.
  • the depth of penetration of the products to be delivered which depends on the depth of penetration of the current fluxes T, is controlled by the spacing between transmitter pins 2 and the neighbouring ground pins 3, which is thus preferably adapted to a specific application of the handheld device of the invention and/or to the applied product.
  • the locally applied current fluxes T locally open the interstitial channels and allow the penetration of the pharmacological and/or natural and/or cosmetic products applied between the skin S and the handheld device 1 in a limited thickness of the skin S.
  • the theoretical depth of penetration is the half of the distance between a transmitter pin 2 and the neighbouring ground pin 3.
  • the actual depth of penetration depends on the volatility of the solvents, on the ambient temperature, on the temperature of the treated surface, on the temperature of the applied products, on the state of the treated skin (hard skin layer more or less thick), on the emitting power of the device.
  • the actual depth of penetration can thus vary by more or less 50% from the theoretical value.
  • the depth of penetration is kept low, usually around one to a few millimetres.
  • the depth of penetration is typically around 1 .5 to 2 mm.
  • the spacing between two neighbouring pins of opposite polarity is thus typically 3 to 4 mm for such an application.
  • the circular arrangement of the pins 2, 3 as shown for example in Fig. 3 is considered to be the most simple and functional arrangement, because it enables a perfect alternating sequence of transmitter pins 2 and ground pins 3 to be created, thus generating regular and well controlled electrical fluxes.
  • the head 1 of the handheld device When the pharmacological and/or natural and/or cosmetic product has been applied on the area to be treated, for example the patient's scalp, the head 1 of the handheld device is to be applied to the same area and a rubbing action is to be applied to the area through the conductive silicone rubber pins 2 and 3, by a manual movement which is for example slow and rotational.
  • the treatment time is very brief, being in the range from 5 to 10 minutes and can be performed by any person, even by the user being treated himself. Because of the effective depth of penetration of the specific product for the regrowth of the hair, the treatment is preferably repeated periodically, once per week for example, until the desired result is achieved.
  • the head 1 of the handheld device of the invention is preferably interchangeable, for example in order to comply with the established hygiene standards.
  • Several interchangeable heads 1 can thus be foreseen, where each head comprises transmitter pins and ground pins distributed in another arrangement adapted to a specific application.
  • the electroporation system is thus a set comprising a plurality of interchangeable heads, each head being adapted to the application of another specific product and/or to the application of products to another part of the human body.
  • the pins 2, 3 are preferably made of conductive silicone rubber or any other flexible and conductive material. The use of flexible transmitter pins 2 and ground pins 3 allow for a better adaptation of the head 1 to the shape of the treated surface.
  • the flexible pins 2, 3 of the head 1 can for example all be in contact with the skin S, even if the head 1 is flat while the treated surface is slightly curved. Due to their flexibility, some pins 2, 3 will be bent and/or compressed when applied against the concave parts of the treated surface, thus allowing the other pins to also be in contact with the skin.
  • the distribution of the electrical fluxes T over the treated area thus remains substantially constant relative to the position of the head 1 , allowing for a regular penetration of the applied product into the skin S.
  • the flexible material used for the pins 2, 3 is furthermore electrically conductive for conducting the electric pulses generated by the handheld device of the invention to the tip of the transmitter pins 2, where the electrical fluxes T will be created to the tip of the neighbouring ground pin(s) 3.
  • the pins 2, 3 thus act as electrodes of opposite polarity that are placed in direct contact with the treated skin surface.
  • the principle of transdermal delivery according to the invention is not limited to products for hair regrowth, but can be extended efficiently to any specific product for other transdermal treatments, such as treatments for psoriasis, dandruff and various skin pathologies, including chemotherapy for the treatment of benign skin tumours or for the removal of visible signs of malignant skin tumours, and the like.

Abstract

L'invention porte sur un dispositif portatif pour administrer des produits pharmacologiques et/ou naturels et/ou cosmétiques par électroporation dans des couches de la peau d'épaisseur limitée (S), comprenant une tête (1), une pluralité de broches émettrices (2) faites à partir d'un matériau électriquement conducteur se projetant à partir de la tête (1), les broches émettrices (2) étant électriquement isolées à partir de la tête (1) et électriquement connectées à un générateur d'onde d'électroporation (5), et une pluralité de broches de mise à la masse (3) faites à partir d'un matériau électriquement conducteur se projetant à partir de la tête (1), les broches de mise à la masse (3) étant électriquement isolées de la tête (1) et desdites broches émettrices (2) et électriquement connectées à la masse (7).
PCT/EP2009/054852 2008-04-22 2009-04-22 Dispositif d'électroporation WO2009130258A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITCO20080016 ITCO20080016A1 (it) 2008-04-22 2008-04-22 Manipolo per elettroporazione di prodotti farmacologici e/o naturali e/o estetici su strati cutanei a spessore contenuto
ITCO2008A000016 2008-04-22

Publications (1)

Publication Number Publication Date
WO2009130258A1 true WO2009130258A1 (fr) 2009-10-29

Family

ID=40296746

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2009/054852 WO2009130258A1 (fr) 2008-04-22 2009-04-22 Dispositif d'électroporation

Country Status (2)

Country Link
IT (1) ITCO20080016A1 (fr)
WO (1) WO2009130258A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202000031379A1 (it) 2020-12-18 2022-06-18 Curaleaf International Ltd Formulazione farmaceutica topica e metodo per il trattamento delle sindromi associate a dolore pelvico cronico

Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5128257A (en) * 1987-08-31 1992-07-07 Baer Bradford W Electroporation apparatus and process
US5911223A (en) * 1996-08-09 1999-06-15 Massachusetts Institute Of Technology Introduction of modifying agents into skin by electroporation
US5983131A (en) * 1995-08-11 1999-11-09 Massachusetts Institute Of Technology Apparatus and method for electroporation of tissue
WO2001068889A2 (fr) * 2000-03-16 2001-09-20 Malone Robert W Procede de transfection genique et de vaccination a travers la peau par electropermeabilisation
US6520950B1 (en) * 1999-05-10 2003-02-18 Genetronics, Inc. Method of electroporation-enhanced delivery of active agents
WO2003046170A1 (fr) * 2001-11-27 2003-06-05 Cellectricon Ab Procede d'administration parallele combinee d'agents et d'electroporation pour structures cellulaires et utilisation associee
US20040167458A1 (en) * 2002-03-07 2004-08-26 Ruxandra Draghia-Akli Electrode assembly for constant-current electroporation and use
US20040186466A1 (en) * 2003-03-17 2004-09-23 Chornenky Victor I. Apparatus and method for hair removal by electroporation
US20050118705A1 (en) * 2003-11-07 2005-06-02 Rabbitt Richard D. Electrical detectors for microanalysis
WO2006128068A1 (fr) * 2005-05-26 2006-11-30 The Regents Of The University Of California Electroporation et transfert de masse regules a travers les membranes cellulaires des tissus
US20070203549A1 (en) * 2005-12-29 2007-08-30 Ardian, Inc. Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach
US20080091135A1 (en) * 2006-10-17 2008-04-17 Ruxandra Draghia-Akli Electroporation devices and methods of using same for electroporation of cells in mammals

Patent Citations (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5128257A (en) * 1987-08-31 1992-07-07 Baer Bradford W Electroporation apparatus and process
US5983131A (en) * 1995-08-11 1999-11-09 Massachusetts Institute Of Technology Apparatus and method for electroporation of tissue
US5911223A (en) * 1996-08-09 1999-06-15 Massachusetts Institute Of Technology Introduction of modifying agents into skin by electroporation
US6520950B1 (en) * 1999-05-10 2003-02-18 Genetronics, Inc. Method of electroporation-enhanced delivery of active agents
WO2001068889A2 (fr) * 2000-03-16 2001-09-20 Malone Robert W Procede de transfection genique et de vaccination a travers la peau par electropermeabilisation
WO2003046170A1 (fr) * 2001-11-27 2003-06-05 Cellectricon Ab Procede d'administration parallele combinee d'agents et d'electroporation pour structures cellulaires et utilisation associee
US20040167458A1 (en) * 2002-03-07 2004-08-26 Ruxandra Draghia-Akli Electrode assembly for constant-current electroporation and use
US20040186466A1 (en) * 2003-03-17 2004-09-23 Chornenky Victor I. Apparatus and method for hair removal by electroporation
US20050118705A1 (en) * 2003-11-07 2005-06-02 Rabbitt Richard D. Electrical detectors for microanalysis
WO2006128068A1 (fr) * 2005-05-26 2006-11-30 The Regents Of The University Of California Electroporation et transfert de masse regules a travers les membranes cellulaires des tissus
US20070203549A1 (en) * 2005-12-29 2007-08-30 Ardian, Inc. Methods and apparatus for pulsed electric field neuromodulation via an intra-to-extravascular approach
US20080091135A1 (en) * 2006-10-17 2008-04-17 Ruxandra Draghia-Akli Electroporation devices and methods of using same for electroporation of cells in mammals

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT202000031379A1 (it) 2020-12-18 2022-06-18 Curaleaf International Ltd Formulazione farmaceutica topica e metodo per il trattamento delle sindromi associate a dolore pelvico cronico
WO2022129274A1 (fr) 2020-12-18 2022-06-23 Curaleaf International Limited Formulation pharmaceutique topique et procédé de traitement de syndromes associés à des douleurs pelviennes chroniques

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