Treatment apparatus and methods
Treatment apparatus and methods are described for treating the meibomian glands of a subject. The system may generally include a substrate layer having one or more heating elements incorporated, a ductile layer attached in proximity to the substrate layer and configured to conform and retain a shape of the heating strip to an anatomy of an underlying region of skin of an eyelid of a subject, and a protective layer attached in proximity to the ductile layer. The system may further include a controller which is programmable for a treatment therapy and which is in communication with the substrate layer via a connecting cable which transmits electrical energy to the substrate layer which receives the electrical energy and emits thermal energy which is conducted throughout the strip via the ductile layer to the underlying region of skin.
1 . A heating strip system, comprising:
a substrate layer having one or more heating elements incorporated;
a flexible connector formed from the substrate layer and configured to extend from the substrate layer;
a ductile layer attached in proximity to the substrate layer and configured to conform and retain a shape of the substrate layer to an anatomy of an underlying region of skin of an eyelid of a subject;
a protective layer attached in proximity to the ductile layer and where the protective layer, ductile layer, and substrate layer each has a contour which is identical to one another, where the ductile layer and the protective layer are coextensive with a treatment portion of the substrate layer to define a peripheral boundary of the treatment portion, and where the flexible connector is further configured to extend beyond the peripheral boundary, and where each layer defines an opening at each end and at a central portion away from a proximal edge and a distal edge such that each opening coincides with one another when each layer is aligned upon one another, and where each layer is assembled into a heating strip such that the heating strip presents a flush and smooth surface configured to adhere to the underlying region of skin and where the heating strip has a flexibility sufficient to accommodate movement of the eyelid to allow for the subject to blink naturally without restriction while conforming and retaining its shape to the underlying region via the ductile layer; and
a controller which is programmable for a treatment therapy and which is in communication with the substrate layer via the flexible connector which is configured to transmit electrical energy to the substrate layer which is configured to receive the electrical energy and emit thermal energy for conduction throughout the heating strip via the ductile layer such that the thermal energy is directed inwardly via the protective layer to the underlying region of skin.
2 . The system of claim 1 wherein the heating strip has a first periphery which is shaped to extend and follow a border of one or more meibomian glands contained within the underlying region of skin, and the heating strip further has a second periphery which is shaped to extend and follow a free margin of the eyelid.
3 . The system of claim 2 wherein the heating strip is configured to adhere to an upper eyelid.
4 . The system of claim 3 further comprising a second heating strip in communication with the controller and configured to adhere to a lower eyelid of the subject.
5 . The system of claim 4 wherein the heating strip and second heating strip are electrically coupled to one another via a coupler.
6 . The system of claim 1 wherein the heating strip comprises a contact surface for placement against the underlying region of skin.
7 . The system of claim 1 wherein the controller is programmed to control one or more parameters of the heating strip.
8 . The system of claim 7 wherein the one or more parameters comprise a temperature, treatment time, frequency of treatment, or thermal profile of the heating strip.
9 . The system of claim 7 wherein the controller is programmed to heat the heating strip to a temperature of between 40° to 50° C.
10 . The system of claim 7 wherein the controller is programmed to heat the heating strip to a temperature up to 45° C.
11 . The system of claim 7 wherein the controller is programmed to heat the heating strip to a temperature of between 40.5° to 44.5° C.
12 . The system of claim 7 wherein the controller is programmed to heat the heating strip to a temperature of between 41.5° to 43.5° C.
13 . The system of claim 1 further comprising one or more temperature sensors incorporated into the heating strip for regulating a temperature of the heating strip.
14 . The system of claim 1 wherein the controller is programmed to heat the heating strip for at least between 10 minutes and 60 minutes.
15 . The system of claim 1 wherein the controller is programmed to heat the heating strip for up to 15 minutes.
16 . A method of treating a subject, comprising:
conforming a heating strip to an underlying region of skin of an eyelid of a subject via a ductile layer which conforms and retains its shape within the heating strip such that the heating strip retains a shape of an anatomy of the underlying region of skin, wherein the ductile layer is positioned between a protective layer and a substrate layer and further presents a flush and smooth surface and where the protective layer, ductile layer, and substrate layer each has a contour which is identical to one another, and where the ductile layer and the protective layer are coextensive with a treatment portion of the substrate layer to define a peripheral boundary of the treatment portion, and where each layer defines an opening at each end and at a central portion away from a proximal edge and a distal edge such that the openings coincide with one another when each layer is aligned upon one another;
initiating a treatment with the heating strip via a controller transmitting electrical energy to the substrate layer of the heating strip having one or more heating elements via a flexible connector formed from the substrate layer and configured to extend from the substrate layer, and where the flexible connector is further configured to extend beyond the peripheral boundary of the treatment portion of the substrate layer; and
conducting thermal energy from the substrate layer throughout the heating strip via the ductile layer such that the thermal energy is directed inwardly via the protective layer and into the underlying region of skin.
17 . The method of claim 16 wherein the heating strip has a flexibility sufficient to accommodate movement of the eyelid to allow for the subject to blink naturally without restriction from the heating strip while covering one or more meibomian glands contained within the eyelid with the heating strip.
18 . The method of claim 17 wherein the heating strip has a first periphery which is shaped to extend and follow a border of the one or more meibomian glands contained within the eyelid and a second periphery which is shaped to extend and follow a free margin of the eyelid.
19 . The method of claim 16 wherein conforming the heating strip comprises adhering the heating strip to an upper eyelid of the subject.
20 . The method of claim 19 further comprising adhering a second strip to a lower eyelid of the subject such that one or more meibomian glands contained within the lower eyelid are covered by the second strip.
21 . The method of claim 20 wherein the heating strip and the second strip are electrically coupled to one another.
22 . The method of claim 16 wherein initiating the treatment comprises programming the heating strip via the controller attached to the substrate layer.
23 . The method of claim 22 wherein programming the heating strip comprises controlling one or more parameters of the heating strip.
24 . The method of claim 23 wherein controlling the one or more parameters comprises controlling a temperature, treatment time, frequency of treatment, or thermal profile of the heating strip.
25 . The method of claim 23 wherein controlling the one or more parameters comprises heating the heating strip to a temperature of between 40° to 50° C.
26 . The method of claim 23 wherein controlling the one or more parameters comprises heating the heating strip to a temperature up to 45° C.
27 . The method of claim 23 wherein controlling the one or more parameters comprises heating the heating strip to a temperature of between 40.5° to 44.5° C.
28 . The method of claim 23 wherein controlling the one or more parameters comprises heating the heating strip to a temperature of between 41.5° to 43.5° C.
29 . The method of claim 16 wherein the method of treating comprises treating one or more conditions selected from the group consisting of dry eye, evaporative dry eye, and Meibomian gland dysfunction.
30 . The method of claim 16 wherein the method of treating comprises treating to improve one or more conditions selected from the group consisting of an ocular surface inflammation, degraded tear quality, degraded lipid layer of tears, and shortened tear break up time.
31 . The method of claim 16 further comprising monitoring a temperature of the heating strip via one or more temperature sensors incorporated into the heating strip.
32 . The method of claim 16 wherein conducting thermal energy comprises heating the heating strip for at least between 10 minutes and 60 minutes.
33 . The method of claim 16 wherein conducting thermal energy comprises heating the heating strip for up to 15 minutes.
34 . The method of claim 16 wherein the method comprises treating the subject for a condition selected from the group consisting of meibomitis, blepharitis, ocular rosacea, acne, arthralgia, myalgia, hordeolum, styes, chalazion, and abcesses.
35 . The method of claim 16 wherein the method comprises treating the subject for a condition selected from the group consisting of conjunctivitis, keratitis, keratopathy, iritis, cyclitis, glaucoma, and cataract.
36 . The method of claim 16 wherein the method comprises treating the subject for improving a comfort level for wearing a contact lens.