Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...
Reexamination Certificate
2000-03-10
2003-04-22
Lazarus, Ira S. (Department: 3749)
Surgery
Means for introducing or removing material from body for...
Infrared, visible light, ultraviolet, x-ray or electrical...
C607S148000, C604S501000
Reexamination Certificate
active
06553253
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention generally relates to the electrokinetic delivery of a substance (for example, a medicament) into tissue and, more particularly, to a method and system for such delivery that satisfies certain risk criteria for medical equipment that maintains direct electrical contact with human skin. The majority of applications using the present invention are for applying medicaments to treatment sites and therefore the term medicament is used in lieu of the term substance throughout this description.
One type of electrokinetic delivery mechanism is iontophoresis. Iontophoresis is the transfer of ionic agents into tissue by means of electricity. The active component of the medicament, either directly ionizable or attached to a carrier ion and either positively or negatively charged, is driven into the tissue by a properly biased electrode through barriers such as animal (including human) skin, cell and mucosal membranes and other barrier surfaces. Iontophoresis has been used to deliver, among other things, morphine HCL for postoperative pain relief, topical anesthetics (such as lidocaine) for transdermal anesthetization, anti-viral agents for herpes infection, and anti-fungal medicines for athlete's foot. The use of iontophoretic transdermal or transmucocutaneous delivery techniques obviates the need for hypodermic injection for many medicaments, thereby eliminating the concomitant problems of trauma, pain and risk of infection to the patient. Such delivery techniques may also be utilized for controlled or localized treatment especially when a substantial systemic involvement of the medicament is unwanted or harmful.
Regardless of the charge of the medicament to be administered, conventional iontophoretic delivery devices typically employ two electrodes (an anode and a cathode). In conjunction with the patient's skin or mucosa, the first (applicator or treatment) electrode is positioned at a treatment site on the skin or mucosa, and the second (counter) electrode is affixed to a second site on the skin or mucosa. These electrodes form a current path that enhances the rate of penetration of the medicament into the treatment site adjacent to the applicator electrode. A conventional iontophoretic delivery system
100
is shown in FIG.
1
. System
100
includes a treatment electrode (anode)
102
and a counter electrode (cathode)
104
connected to a DC power supply
106
. Electrodes
102
and
104
are in electrical contact with the skin or mucosa via conductive layers
110
and
112
, respectively. Such layers may be part of a single medicament-carrying substrate. The medicament-carrying substrate is generally disposable and non-reusable and may be releasably adherable to the patient's treatment site and/or to electrodes
102
and
104
. Conductive layers
110
and
112
are shown in
FIG. 1
as comprising a medicine-soaked sponge (e.g., a morphine HCL-soaked sponge) and a saline-soaked sponge, respectively. In use, iontophoretic device
100
is turned on (e.g., by a switch, not shown) and a current flows from treatment electrode
102
, through conductive layer
110
and skin plus underlying tissue
108
, to counter electrode
104
, thereby driving medicament through the treatment site into the skin and underlying tissue.
Although use of alternating current has been reported (see, e.g., U.S. Pat. No. 5,224,927), direct current is generally preferred in iontophoresis. As set forth in the '927 patent, at AC frequencies higher than approximately 10 Hz, no substantial effective drug delivery takes place. Medicament and other ions merely move to and fro, lacking any net unidirectional movement. For DC iontophoresis, the amount of current used varies from 0.2 to 1 milliampere, which exceeds the risk-current limit of 10 microamperes for medical equipment that maintains direct electrical contact with the patient. There exists, therefore, a potential hazard associated with ventricular fibrillation and cardiac arrest if the current generated during iontophoresis accidentally passes through the patient's heart. In iontophoresis, the rate of drug delivery increases with current. For this reason, higher current is, in principle, always favored because treatment time is proportionally reduced. However, for current exceeding 0.5 to 1 milliampere, the patient will feel an uncomfortable burning sensation. Even at the 0.5 to 1 milliampere range, when the treatment area is relatively small, the resulting high current density can cause severe pain and actual burning and destruction of the skin tissue.
In any case, to remain effective, existing iontophoresis devices may use treatment currents exceeding the established risk-current limit. In order to reduce the ventricular fibrillation risk, some devices limit the separation distance between the treatment and the counter electrode so that the heart is not directly in the current path and is therefore less likely to be included within the fringe electric fields created by the electrodes. However, because electric current always flows through a path of least resistance, the electrode separation distance needs to be large enough so that current is not short-circuited or concentrated between proximal edges of the electrodes (i.e., between edges
120
and
130
in FIG.
1
), so that the current distribution under the treatment electrode is relatively uniform for effective drug delivery, and so that there are no hot-spots or areas of high current density to cause discomfort and pain. Such an approach for cardiac risk avoidance can be further compromised in situations where the patient can touch by fingers or hand the skin area near the electrodes such that the treatment current is diverted and passes through the heart via the arm. Some electrophoresis devices use a large separation distance to achieve a uniform current distribution but place the counter electrode in a less accessible location such as the back or the rear shoulder of the patient.
An effective method for self-administration of a medicament into an individual's skin is disclosed in U.S. Pat. No. 5,676,648 and uses a small cylindrical probe in which the treatment applicator electrode is located at the distal end of a counter electrode consisting of a circumferential tactile metal band which provides electrical connection to the individual's finger and hand. The individual's body completes a long electrical circuit path (through the arm and torso), and thus a uniform current distribution and effective medicament delivery is assured.
SUMMARY OF THE INVENTION
It is desirable to use a system and method for electrokinetic delivery of medicament into tissue that reduces hazards associated with introducing electrical currents into the human or animal body.
In accordance with one aspect of the present invention, an electrokinetic system for delivering a substance into tissue includes an alternating current source of a predetermined frequency. A first electrode is coupled to a first terminal of the alternating current source and a second electrode is coupled to a second terminal of the alternating current source. A rectifying circuit is coupled between the first electrode and the first terminal of the alternating current source. One of the first and second electrodes is adapted for electrical contact with a substance-delivery site. A current rectified by the rectifying circuit flows between the first and second electrodes when the one of the first and second electrodes is in electrical contact with the substance-delivery site to effect delivery of the substance into the tissue.
In accordance with another aspect of the present invention, an electrokinetic method for delivering a substance into tissue includes providing a substance at a treatment site. A rectified current is generated from an alternating current source and the rectified current is caused to flow through the substance to deliver the substance into the tissue.
As an example of an electrokinetic delivery mechanism, iontopheresis carried out as described above satis
Biophoretic Therapeutic Systems, LLC
Lazarus Ira S.
Nguyen Tu Cam
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