Abstract
The subject Device is an integrated therapy system in a bandage-like package optimized for specific medical conditions or diseases. The Device is designed around a layered package and delivers optimum medications and healing conditions to the skin or another membrane. The layers within the Device consist of passive or active components including medications, fluidic reservoirs and transport, dispersal pads, sensors, and electronic components, and these layers can be applied or not applied to the condition being addressed.
Claims
1. A drug delivery and healing Device using a multilayered construction similar to a bandage that is configured and/or constructed for specific medical indications, comprising: a. Layers with either or both active and passive properties b. Delivery of medication specific to the condition being treated c. A means to contain the medication to the active site
2. The Device in claim 1, where additionally the control of the healing environment is maintained in terms of any environmental factor, including but not limited to: a. Temperature control which may include both heating and cooling b. Oxygen control which may include both increasing or decreasing oxygenation c. Pressure control d. Humidity control
3. The Device described in claim 1, where active layers can include one or more electronic and electrical layers including functions such as logic, timers, controllers, dispensers, actuators, and communications.
4. The Device described in claim 1, where an active electronic layer may contain sensors, including but not limited to: a. Patient vital signs b. Environmental factors necessary for closed loop control of the items in claim 2.
5. The DeviCe described in claim 1, where layers may contain one or more reservoirs for medications which can be dispensed actively (electronically) or manually.
6. The Device described in claim 1, where an electronic layer can communicate with other devices for either or both of the following: a. Recording and logging patient condition and treatment results b. Configuring or adjusting the functions of the Device.
7. The Device described in claim 1, where layers can include, but are not limited to: a. Dermal contact layer with non-stick and antiseptic properties offering an optional seal around the treatment area. b. Continuous medication layer with or without impregnated medications such as an antibiotic and which also forms a pad for the delivery of additional medications by other layers. c. Fluidic reservoir layers d. Time release medication layers, using either active or passive techniques e. Active electronic or electrical layer f. Environmental control layers
8. The Device described in claim 1 for uses other than transdermal medical delivery.
Description
DESCRIPTION OF DRAWINGS
[0047] FIG. 1 shows an expanded view of the multi-layer structure, which could be laminated or otherwise secured on the edges to form the device. Callout 1 shows a wound or surface condition that the therapy will address. Item 2 identifies a skin surface, or other organ or the subject to which the device will attach. Item 3 shows a base layer described above that consists of a sterile, permeable, non-stick pad which may or may not have a sealed edge in contact with item 2.
[0048] Item 4 in FIG. 1 shows the top layer, which may be a cosmetic overlay, or may have various properties of elastic for compression, permeability for oxygen, or other characteristics. Item 5 shows the multiple layers, here there are three, used in the construction of the active components of the device.
[0049] FIG. 2 shows some possibilities for the active layers of the device. The layers can occur in any order as needed to construct the appropriate functions for the therapy device. Item 6 shows a traditional pad layer, which might also include antibiotic or disinfectant within that structure. It could be foam, a woven polyester, or an organic fiber, and might also be constructed from a gel polymer. Item 9 shows an active electronic circuit layer, with Item 7 being an electronic circuit, Item 8 being an onboard battery which itself could be a laminate or a small cell such as a hearing aid battery. Item 10 illustrates other active electronic components, such as a pressure actuator or a switch. Not the correspondence in location of the pressure actuator and the fluidic reservoir in Item 12.
[0050] Item 11 in FIG. 2 shows an active layer containing in this case a plurality of fluid reservoirs 12. The fluid reservoirs can be associated with multiple medications and can be manually or electronically dispensed, or can be dispensed through capillary action as a time release mechanism. Fluid reservoirs can have a one time seal, such as by bursting micro balloons, a valve or other device, leading either to direct saturation of the layer below, or through the small capillary tubes indicated in Item 13. The tubes can be folded under other layers in the construction of the device, so that dispensing can be accomplished in any layer desired.
[0051] FIG. 3 shows addition and primarily passive layer possibilities. Item 14 is a series of sealed fluidic reservoirs that are evacuated through finger pressure, such as in the bug bite bandage usage case, although in this case five micro balloons are shown. In the bug bite bandage these would be single doses 15 of a mild anesthetic to reduce itching.
[0052] Item 16 in FIG. 3. shows a layer that would be pre-saturated with a continuous or time release medication. The medication would be specific to the specific indications for the condition being treated, as discussed in the usage cases above. Item 17 would be the saturated medication. Similarly, layers can be provided for Peltier heating and cooling. Temperature cycling is indicated for all types of orthopedic surgeries, dental surgeries, sprains, soft tissue injuries, etc.
[0053] Item 18 in FIG. 3 shows an encapsulating honeycomb structure material that can be used to both deliver very small doses of medication in highly targeted areas, can benefit time release of medications according to the honeycomb 19 size, and can respond to mechanical pressure, again either manually or with electronic or pressure actuators, release medication on command.
[0054] FIG. 4 expands on the layered delivery technique by adding electronic sensors as well as fluidic operations. Sensors including but not limited to temperature, humidity, liquid detection, oxygenation, vital signs, and pressure can be supplied and positions as needed for therapeutic effect, combining with the electronic capability shown in Item 9. A sensor equipped layer 20 contains electronic circuitry 21 which may or may not be mechanically flexible with the layer. Flexible wiring 22 connections to a protrusion from the layer, which can be wrapped or folded to place the active sensor in the desired location on the device. Finally, a sensor 24 is located at the end of the flexible wiring for the above functions. The combination of the electrical layer disclosed here with a fluidic or fluid saturated layer can be used to deliver oxygen through the use of an electrode (anode) and electrolyte, thereby allowing oxygen level to be measured and manipulated for therapeutic effect.
