Surgery – Means for introducing or removing material from body for... – Infrared – visible light – ultraviolet – x-ray or electrical...
Reexamination Certificate
1999-01-29
2001-11-13
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Infrared, visible light, ultraviolet, x-ray or electrical...
C607S154000
Reexamination Certificate
active
06317630
ABSTRACT:
BACKGROUND OF THE INVENTION
Medical and cosmetic preparations whose molecules are too large to be easily accommodated by skin pores are not efficacious in topical application. Various methods for increasing the efficacy of these preparations in topical application are known. One such method is the iontophoretic process.
Iontophoresis is the migration of ions when an electric current is passed through a solution containing the ions, usually the ionic form of a drug or therapeutic agent. Iontophoresis can provide the non-invasive transdermal delivery of ionized drugs to a patient by applying a current to a patch placed on a patient's skin. The current forces the medication, located in the patch or on the patient, to enter the patient's bloodstream through the skin.
Electromagnetic energy in the radio frequency (RF) range has also been described as useful to aid in the healing of damaged tissue. Often, large systems including an antenna and an RF generator are positioned near tissue to be treated. Due to the size and cost of these systems, patients require scheduled appointments for treatment and positioniing of the wound or treatment area can be awkward and uncomfortable.
The application of an electromagnetic field to the body is also used to enhance vascular efficiency. Increased excitation of the vascular system is an important component to wound healing.
Iontophoresis is known to enhance drug delivery over passive transdermal delivery. In the treatment of cancerous tumors, it has been argued that a therapy of iontophoretic drug delivery and the separate application of electromagnetic energy results in either increased drug delivery to the targeted area or a decrease in the amount of drug needed to be delivered due to heightened efficiency of the delivery. These treatments must be delivered separately with existing systems.
A continuing need exists, however, for providing improvements to current methods for the transdermal delivery of medications.
SUMMARY OF THE INVENTION
The invention relates to a drug delivery device that can be used to deliver a current and electromagnetic energy to a site. The device call include a membrane having electrodes that deliver a current to a medication or preparation for transdermal delivery, an antenna for transmitting electromagnetic energy into the tissue underlying the membrane that can provide treatment of the tissue and/or enhance delivery of the medication, and a circuit that connects a control signal source to the antenna, and the electrodes.
This system solves problems associated with the prior art by providing a small portable device for the use of electromagnetic energy to aid in the delivery of medication. This has several advantages including increased blood circulation at the site and/or enlarging of pores in the skin thereby increasing the flow of medication. The present system thus provides a non-invasive method for adjusting physiologic, metabolic and growth behavior of cells and tissues. The electromagnetic signals call also be used to treat conditions such as pain and edema associated with soft tissue injuries.
In one embodiment of the invention, medication to be delivered to a patient is independent from the drug delivery device. For example, a medication can first be applied to a patient's skin and the drug delivery device then placed on the patient in contact with the medication. In another preferred embodiment, the medication is stored in a reservoir in the membrane or in the control housing prior to use of the drug delivery device. The removal of an adhesive backing to expose an adhesive on the membrane that secures the membrane to the patient can also expose medication on the membrane surface.
A control signal source is contained within a controller housing having surface contacts that match the interface contacts of the membrane. The controller housing can have an upper surface with one or more buttons to control operation of the membrane. The controller housing contains a battery to power the device, a microprocessor or integrated control circuit connected to an RF transmitter, and a current stabilizer circuit.
In one embodiment, the control signal source allows for the simultaneous application of the electromagnetic fields and current to a site. The control signal source can also allow for independent application of either the electromagnetic field or the current to a site or can allow for application of the electromagnetic field and the current in an alternating pattern. The drug delivery device provides a small, light weight, low power control signal source that can simultaneously, or in any selected sequence, deliver an iontophoretic treatment and/or an electromagnetic signal to a region of interest. Low power operation has provided an increase in the frequency range available for use.
In another embodiment, the control housing contains a selector which allows the user to manually select the target physiologic site and the type of drug to be delivered to the site from a programmed control sequence. Selecting for a specific drug and target tissue will change the characteristics of the electromagnetic field and current produced by the control signal source. In another embodiment, selection of a physiologic site or region of interest and the type of drug to be delivered from a programmed control sequence is done from a remote computer. The computer provides the control sequence to the control signal source by either a standard cable connection or a wireless transmission.
The membrane can be attached to the control housing by an adhesive, or by other electrical, magnetic or mechanical attachment methods. Separation of the membrane and the control housing provides for reuse of the control signal source with the membrane being disposable.
In another embodiment of the invention, the membrane and control signal source are integrated in a single unit such that the antenna and electrodes are directly connected to the control circuit. Depending upon the particular application, the entire unit can be disposable or it can be sterilized for further use.
The invention also relates to a method of using a drug delivery device. The method includes applying a medication to a patient, attaching a membrane containing an antenna for transmitting an electromagnetic field and electrodes for transmitting a current over the medication area, and connecting the antenna and the electrodes to a control signal source. The method further includes activating the control signal, applying the electromagnetic field and current to the medication area, and stimulating the medication to travel through the skin of the patient.
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Gross Yossi
Nitzan Zvika
Hamilton Brook Smith & Reynolds P.C.
Kennedy Sharon
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