Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...
Reexamination Certificate
2002-04-08
2004-09-14
Gartenberg, Ehud (Department: 3743)
Surgery
Means for introducing or removing material from body for...
Infrared, visible light, ultraviolet, x-ray or electrical...
C604S501000, C604S020000, C607S149000, C607S150000
Reexamination Certificate
active
06792306
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to the electrokinetic mass transfer of substances into and/or extracting substances from tissue and particularly to apparatus and methods for extracting, e.g., body fluids and/or harmful substances from a site, and/or delivering substances, e.g., a medicament to a treatment site.
Electrokinetic delivery of medicaments for applying medication locally through an individual's skin is known. One type of electrokinetic delivery mechanism is iontophoresis, i.e., the application of an electric field to the skin to enhance the skin's permeability and to deliver various ionic agents, e.g., ions of soluble salts or other drugs. In certain situations, iontophoretic transdermal or transmucocutaneous delivery techniques have obviated the need for hypodermic injection for many medicaments, thereby eliminating the concomitant problem of trauma, pain and risk of infection to the individual. Other types of electrokinetic delivery mechanisms include electroosmosis, electroporation, electromigration, electrophoresis and endosmose, any or all of which are generally known as electrotransport, electromolecular transport or iontophoretic methods. The electrokinetic delivery mechanism may also be accompanied by ultrasonic vibration to further facilitate electrokinetic transport of the substance, e.g., by opening pathways in the skin. Ultrasound may be employed in a number of ways such as (i) traditional piezoelectric elements, (ii) magnetostrictive alloys, (iii) Application Specific Integrated Circuits (ASICS) with an ultrasound transmitter built in or (iv) by thin foil sheets with incorporated piezoelectric dipole elements. See, for example, U.S. patent application Ser. No. 09/205,751, filed Dec. 4, 1998, of common assignee herewith, the disclosure of which is incorporated herein by reference.
There are several difficulties with electrokinetic delivery of substances such as medicaments. One is the heretofore need for somewhat cumbersome, bulky and costly equipment which oftentimes requires the presence of an individual at a doctor's office or treatment center and use of medical professionals to administer the medicament. Private, self-administration of medicaments or for diagnostic application by the individual at non-medical or non-professional facilities is highly desirable. Also, an easily transportable apparatus for electrokinetic delivery of medication, for example, a lightweight, compact portable device useful with an applicator packaged as a single or unit dosage applicator, and which may be readily and easily manipulated to contact the treatment site appears ideal as a patient/consumer friendly self-administration system appropriate for many circumstances.
BRIEF DESCRIPTION OF THE INVENTION
In accordance with a preferred embodiment of the present invention, there is provided a portable, self-contained, digit-mounted, lightweight, compact and wireless electrokinetic device or medicator for delivering a substance, e.g., a medicament, for self-administration to a treatment site. By the term substance is meant a medicament as well as natural or homeopathic products that may be outside the definition of medicament, e.g., inks and pigments for tattoos, and more generally includes any substance capable of electrokinetic transport through skin or mucocutaneous membrane, e.g., into a treatment site or from a site, e.g., for diagnostic purposes. The majority of applications using the present invention are for applying medicaments to treatment sites and therefore the terms medicament and substance are used interchangeably, each embracing the other, the term medicament being used in lieu of the term substance throughout this specification for convenience. By medicament is meant any chemical or biologic substance that may be used on or administered to humans or animals as an aid in the diagnosis, treatment or prevention of disease or other abnormal or cosmetic condition or for the relief of pain or to control, diagnose, measure, detoxify or improve any physiologic or pathologic condition. By a treatment site is meant a target tissue, e.g., a diseased tissue, or diagnostic/detoxification site for extraction of a substance, underlying or exposed through or on an individual's skin, cutaneous or mucocutaneous membrane.
In a first aspect of the present invention, an individual may privately self-administer the medicament by employing the self-powered wireless finger-mounted device hereof to electrokinetically drive the medicament into the treatment site, e.g., through the skin or mucocutaneous membrane to a diseased tissue. Preferably, a low-cost digit-mounted device is used to facilitate the flow of medicament into the skin under the influence of the electromotive force supplied to the medicament by the self-powered digit-mounted wireless device. The device is preferably lightweight, compact, inexpensive and portable and comprises a device body or splint configured for mounting on an individual's extremity for self-manipulation and containing a power source, for example, a battery, connected directly or indirectly to first and second terminals and suitable electronics controlling and interfacing with active and counter electrodes. The device is preferably mounted on the individual's finger to facilitate manipulation of the device so that the active electrode connected to the first terminal may be located against the skin or mucocutaneous membrane, i.e., the treatment site. The second terminal of the power source is coupled with the counter electrode, i.e., a tactile electrode, on the surface of the device for electrical contact with a second skin site, e.g., a portion of the individual's finger engaged by the device. The polarity of the active and counter electrodes may be reversed by either a mechanical switch, a relay or solid-state implementation as the application may dictate. By self-manipulation is meant that the individual can mount the device on a finger of one hand or a portion thereof and substantially freely orient the device to engage the active electrode of the device through a substrate containing medicament or a conductive carrier therefor, or directly through medicament interposed between the skin or mucocutaneous membrane and the active electrode, generally wherever the treatment site is located and irrespective of whether a substrate is used and, if used, irrespective of whether the substrate is attached to the device or to the individual's skin or mucocutaneous membrane or interposed therebetween with the device subsequently applied to the substrate.
In a preferred embodiment of the present electrokinetic medicament delivery device, there is provided a substrate having an open cellular structure, for containing the medicament. This preferred open cellular or porous substrate forms a minimum barrier to movement of medicament molecules under the influence of the applied current to electrokinetically transport the medicament molecules into the skin or mucocutaneous membrane. The substrate is preferably pre-filled with a single or unit dose of medicament and pre-packaged with or in an applicator portion of the device prior to application of the device and the attached substrate to the treatment site. It will be appreciated, however, that the substrate can be applied directly to the treatment site or form a substrate interposed between the device, i.e., the active electrode and the treatment site without attachment to the device. For those medicaments which are not per se iontophoretically transportable, the medicament and/or the substrate may be hydrated prior to use or contain a hydrating substance, e.g., water, in prepackaged form containing both the medicament and hydration substance. The hydration substance may contain salts or other ionizable ingredients and is therefore conductive to facilitate electrokinetic transport.
It will be appreciated that upon application of the substrate to the treatment site with the medicament interposed between the active electrode and treatment site,
Chang Kuo Wei
Goldberg Dennis I.
Henley Julian L.
Potter Joseph
Biophoretic Therapeutic Systems, LLC
Gartenberg Ehud
Nixon & Vanderhye
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