Patent Application
20220395402
Various aspects of the present disclosure relate generally to medical devices and related methods for coupling a medical device to the surface of the skin, among other aspects. More specifically, at least certain embodiments of the present disclosure relate to devices including an adhesive patch with a plurality of channels and micro holes, among other aspects.
Wearable healthcare devices, specifically those used in fitness and diagnostic medicine, often require small and portable microcontrollers that can take continuous measurements for long periods of time. One frequently used example of such a device is a wearable electrocardiogram (ECG). An ECG is a tool used by physicians to diagnose heart problems and other potential health concerns. Recording sufficient ECG and related physiological data over an extended period of time remains a significant challenge to healthcare providers. An ECG wearable patch may consist of two electrodes (one channel) in a wearable patch, and one microcontroller mounted to the patch. The surface of each electrode may be coated with an non-conductive adhesive and a hydrogel to reduce body contact resistance, and the microcontroller may be surrounded by a protective cover on top of the patch.
Conventionally, maintaining continual contact between ECG electrodes and the skin after a day or two has been a problem. Time, dirt, moisture, and other environmental contaminants, as well as perspiration, skin oil, and dead skin cells from the patient's body, can get between an ECG electrode's non-conductive adhesive and the skin's surface. Long term collection of such material can lead to skin irritation or allergic reactions. Furthermore, all of these factors adversely affect electrode adhesion and the quality of cardiac signal recordings. The physical movements of the patient and their clothing impart various compressional, tensile, and torsional forces on the contact point of an ECG electrode, especially over long recording times, and an inflexibly fastened ECG electrode will be prone to becoming dislodged. Moreover, dislodgment may occur unbeknownst to the patient, making the ECG recordings inaccurate.
Hence, there exists a need for improved wearable patches and other wearable medical devices for patient monitoring. This disclosure seeks to address at least one of the above problems or other problems in the art.
Aspects of this disclosure relate to wearable medical devices, and related systems and methods. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.
According to one aspect, a medical device may be configured to couple to a body. The medical device may comprise a material layer; a plurality of adhesive layers coupled to the material layer and configured to couple to a user's skin, wherein each adhesive layer of the plurality of adhesive layers includes a plurality of micro passages; a channel extending between two adjacent adhesive layers of the plurality of adhesive layers; and a superhydrophobic coating covering at least a portion of each of the two adjacent adhesive layers and the material layer forming the channel.
In other aspects, the medical device may include one or more of the following features. The material layer may be a flexible, nonwoven material. Each of the plurality of adhesive layers may be a hydrogel and may include at least one of collagen, gelatin, glycerine, aloe vera, methyl paraben, hydrogenated castor oil, and polyacrylamide/polydopamine (PAM/PDA). The superhydrophobic coating may include one or more of carbon nanofiber, manganese oxide polystyrene (MnO2/PS) nano-composite, zinc oxide polystyrene (ZnO/PS) nano-composite, precipitated calcium carbonate, carbon nano-tube structures, silica nano-coating, fluorinated silanes, and fluoropolymer. Each of the plurality of micro passages may be cylindrical and may have a diameter in the range of 1 μm to 100 μm. Each of the plurality of adhesive layers may be rectangular and spaced from each other adhesive layer of the plurality of adhesive layers. The channel may extend from a first edge of the material layer to a second edge of the material layer, and the first edge may be at an opposite end of the material layer from the second edge. The channel may include a first channel and a second channel, and the first channel may extend transverse to the second channel. The first channel may extend from a first edge of the material layer to a second edge of the material layer, and the first edge may be at an opposite end of the material layer from the second edge; and the second channel may extend from a third edge of the material layer to a fourth edge of the material layer, and the third edge may be at an opposite end of the material layer from the fourth edge. The superhydrophobic coating may cover i) an entire first side surface of a first adhesive layer of the plurality of adhesive layers, ii) an entire second side surface of a second adhesive layer of the plurality of adhesive layers, and iii) a surface of the material layer extending between the first side surface and the second side surface. Each of the plurality of micro passages may extend entirely through at least one of the plurality of adhesive layers. The medical device may further comprise an electronic assembly coupled to the material layer. The electronic assembly may comprise a controller, an antenna, and a power source. At least one electrode may be electronically coupled to the electronic assembly. At least one motion sensor may be electronic coupled to the electronic assembly.
In other aspects, a medical device may be configured to couple to a body. The medical device may comprise a material layer; a plurality of adhesive layers coupled to the material layer and configured to adhere to a user's skin, wherein each adhesive layer of the plurality of adhesive layers is spaced from each other adhesive layer of the plurality of adhesive layers; a plurality of channels, wherein each of the plurality of channels extends between two adjacent adhesive layers of the plurality of adhesive layers; and a superhydrophobic coating covering at least a portion of each of the plurality of channels.
In other aspects, the medical device may include one or more of the following features. Each of the plurality of adhesive layers may include a plurality of micro passages extending entirely through the adhesive layer. Each of the plurality of channels may extend from a first edge of the material layer to a second edge of the material layer. The superhydrophobic coating may include one or more of carbon nanofiber, manganese oxide polystyrene (MnO2/PS) nano-composite, zinc oxide polystyrene (ZnO/PS) nano-composite, precipitated calcium carbonate, carbon nano-tube structures, silica nano-coating, fluorinated silanes, and fluoropolymer.
In other aspects, a medical device may be configured to couple to a body. The medical device may comprise a material layer; an electronic assembly coupled to a first side of the material layer; a plurality of adhesive layers coupled to a second side of the material layer and configured to adhere to a user's skin, wherein each adhesive layer of the plurality of adhesive layers is spaced from each other adhesive layer of the plurality of adhesive layers, and wherein the second side is positioned on an opposite side from the first side; a plurality of channels, wherein each of the plurality of channels extends between two adjacent adhesive layers of the plurality of adhesive layers; and a superhydrophobic coating covering each of the plurality of channels.
It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and together with the description, serve to explain the principles of the disclosure.
The present disclosure is drawn to medical patches, systems, devices, and methods for coupling a medical device to a patient, among other aspects. Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term “coupled to tissue” may refer, for example, to adhering, fixing, attaching, clutching, or fastening, or otherwise secured to a user's body. As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.”
Material layer 102 may be a medical woven or non-woven tape, or any other flexible and breathable material. In some examples, material layer 102 may include one or more of cotton, polyester, polypropylene, polyimide, rayon, and polytetrafluoroethylene (PTFE). Material layer 102 may be sterilized, may be treated with anti-microbial agents, may be soft and stretchable, and may either repel or absorb liquids. In some examples; material layer 102 may be a hypoallergenic material. In some examples, material layer 102 may only be permeable in a one direction and may be impermeable in an opposing direction. For example, material layer 102 may be permeable across the surface 151 coupled to each of adhesive layers 104-109 allowing fluid to flow through material layer 102 and through top surface 160, and/or may be impermeable across the top surface 160 not allowing fluid to flow through top surface 160 in a direction towards bottom surface 151.
The one or more adhesive layers 104-109 may include an adhesive hydrogel, and may be configured to adhere to skin of a patient. In other examples, adhesive layers 104-109 may include a plurality of adhesives, such as different types of adhesive hydrogels and/or other forms of adhesive. Adhesive layers 104-109 may include collagen, gelatin, glycerine, aloe vera, methyl paraben, hydrogenated castor oil, polyacrylamide/polydopamine (PAM/PDA), and/or synthetically made materials. Each adhesive layer 104-109 may include a plurality of micro passages 114-119. Each micro passage 114-119 may extend entirely through the adhesive layer 104-109, and may form a grid pattern across the adhesive layer 104-109. Micro passages 114-119 may have a cylindrical shape and may have a diameter in the range of 1 μm to 100 μm (inclusive), or any other suitable diameter. Micropassages 114-119 may be formed via a mold or may be laser cut into adhesive layers 104-109. In some examples, one or more of micro passages 114-119 may contain an air pocket that increases the adhesion of medical patch 100 to skin by acting as a vacuum (via the instant vacuum effect). When medical patch 100 is coupled to a portion of skin of a patient, a first opening of each micro passage 114-119 may be adjacent to and/or abut skin, and adhesive layers 104-109 may couple medical patch 100 to the skin. Micro passages 114-119 may be configured to allow sweat, water, and other liquids to move away from the skin of the patient when medical patch 100 is coupled to the patient's skin. Micro passages 114-119 may increase the flexibility of adhesive layers 104-109 and may facilitate movement of medical patch 100 when coupled to skin of a patient.
Each of channels 120-124 may be coated with a superhydrophobic, or ultrahydrophobic, coating.
Superhydrophobic coatings 241-245 may include carbon nanofiber, manganese oxide polystyrene (MnO2/PS) nano-composite, zinc oxide polystyrene (ZnO/PS) nano-composite, precipitated calcium carbonate, carbon nano-tube structures, silica nano-coating, fluorinated silanes, fluoropolymer, and/or any other superhydrophobic material or combination of materials. Superhydrophobic coatings 241-245 may be applied to channels 120-124 by chemical etching, solution immersion, laser electrodeposition, template deposition, spray coating, or any other application technique known in the art. In some examples, superhydrophobic coatings 241-245 may be applied to an intermediate layer of material (not shown) between i) adhesive layers 104-109 and material layer 102 and ii) the superhydrophobic coating 241-245.
Although medical devices 100, 500 are shown with straight channels 120-124, 520-524, and 531, other examples may include curved channels or other shapes of channels. In some examples, material layers 102, 502 may be any suitable shape and is not limited to rectangular shapes. The shape of adhesive layers 104-109, 504-515 may be any suitable shape or size, such as circular, oval, polygonal, or irregularly shaped. The arrangement of micro passages 114-119, 518, 519 may vary and is not limited to the rows of passages shown. In some examples, micro passages 114-119, 518, 519 may extend entirely through both adhesive layer 104-109, 504-515 and material layer 102, 502. Each of medical devices 100, 500 may be incorporated into a wearable medical device including electronic components, such as a wearable medical device configured to measure one or more bio signals, such as an ECG.
Medical device 800 illustrates an exemplary embodiment of a wearable medical device incorporating medical patch 100. Medical patch 100 may be used as an adhesive patch in other wearable medical devices known in the art, such as different types of wearable ECG devices. It is to be understood that medical devices 100, 500 can be suitably modified, within the scope of this application, to record a variety of physiological signals. The physiological signal may be at least one of electrocardiogram (ECG), electroencephalogram (EEG), electromyogram (EMG), Electroretinogram (ERG), Electrooculography (EOG), Electroolfactogram (EOG), Electropalatogram (EPG), Electrogastroenterogram (EGEG), Electrocochleography (ECOG), Galvanic skin response (GSR) and any other physiological signal. In some examples, medical devices 100, 500 may be used for wound treatment or protection, such as used in a bandage or band aid to cover a wound. In some examples, medical devices 100, 500 may include one or more motion sensors for monitoring movement of a patient.
The medical devices, systems, and methods discussed herein may provide a long term coupling mechanism for wearable medical devices that may reduce the build up of moisture over time, improve device adhesion to a patient's skin, facilitate drainage of liquid away from the wearable medical device while coupled to a patient, and may facilitate drying the area of a patient's skin that is coupled to the wearable device after exposure to liquid. The medical devices, systems, and methods discussed in this disclosure may help reduce skin irritation or allergic reactions caused by wearable medical devices coupled to a patient's skin. Furthermore, the medical devices, systems, and methods discussed in this disclosure may reduce the likelihood of liquid, collected around a wearable medical device, interfering with electrical components of a wearable medical device, such as short circuiting electrical components.
It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed system, methods, and devices without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application claims the benefit of priority under 35 U.S.C. § 119 from U.S. Provisional Application No. 63/208,590, filed on Jun. 9, 2021, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63208590 | Jun 2021 | US |
