Patent Publication Number: US-2017354376-A1

Title: Flexible wireless patch for physiological monitoring and methods of manufacturing the same

Description:
CROSS-REFERENCE 
     This application is a Continuation Application of U.S. application Ser. No. 14/805,389, filed on Jul. 21, 2015, which is a Continuation Application of U.S. application Ser. No. 14/091,252, filed on Nov. 26, 2013, which is a Continuation Application of U.S. application Ser. No. 12/739,561, filed on Nov. 3, 2010, now U.S. Pat. No. 8,628,020, which is a National Stage Entry of PCT/US08/80695, filed Oct. 22, 2008, which claims the benefit of U.S. Provisional Application Nos. 60/982,402, filed Oct. 24, 2007 and 60/982,233, filed Oct. 24, 2007, which applications are incorporated herein by reference in their entirety. 
     This application is related to U.S. Provisional Application No. 60/943,539, filed Jun. 12, 2007; and to PCT/US08/64800, filed on May 23, 2008 which claimed priority to U.S. Provisional Application No. 60/940,072, filed on May 24, 2007, which applications are incorporated herein by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Monitoring physiological conditions of the human body is an important component of health care. Although the monitoring can be performed periodically by a health care professional, increasingly the task is being handled by electronics that connect the patient to a computerized system for data storage, presentation and retrieval. These electronic systems consist of sensors, signal conditioners, power sources and other components needed for the specific physiological conditions being monitored. Most sensors used in monitoring physically contact the body, requiring a method for connecting sensors to the rest of the electronic system. In the past, wires were the only option for this connection, but increasingly wireless methods are being employed. One such wireless design, [P1], describes a sensor patch that attaches to the patient during the monitoring period and sends physiological measurement data to the rest of the system over a radio link. This sensor patch includes interface electrodes, signal conditioning circuits, digitizing converters, a wireless data link (radio), support circuits and a power source (battery). Including all of these components in a patch that might be worn on the body for several days presents several design and manufacturing challenges. This patent describes a method for manufacturing such a patch. 
     SUMMARY OF THE INVENTION 
     Provided herein is an integrated wireless patch which comprises a contact layer comprising a substrate, an electronic layer folded into contact with the contact layer, and a battery layer folded into contact with the electronic layer. The battery layer comprises battery terminal tabs. Additionally, the battery layer can further comprise at least one antenna. The patch can be adaptable to be assembled by positioning the electronic layer between the contact layer and the battery layer. Furthermore, the patch can comprise an adhesive layer adaptable to be located between the contact layer and the electronic layer. In some embodiments, the patch can further comprise a battery. The contact layer can comprise at least one contact adaptable to be in communication with a surface of a patient. The contact layer can further comprise an adhesive surround positioned around the contact. Additionally, the patch can further comprise at least one antenna. The patch can also comprise at least one application-specific integrated circuit on the electronic layer. 
     Further provided herein is a method of manufacturing a wireless integrated patch comprising the steps of: folding a substrate comprising at least one cutout, at least one contact disk in communication with a surface of a patient through the cutout, and battery terminals, wherein the at least one cutout, the at least on contact, and the battery terminals are adaptable to be located in different layers after the substrate is folded. Additionally, the method can comprise the step of attaching a battery to the battery terminals. Cutouts can be created in the substrate prior to the folding step. Furthermore, the method can further comprise the step fabricating at least one contact on the substrate prior to the folding step. In some embodiments of the method, the method can further comprise the step of attaching an ASIC to the substrate and further comprising the step of connecting the at least one contact to the ASIC with a trace. An antenna can be connected to the ASIC as part of the method. Additionally, an adhesive spacer can be inserted he between two layers of the folded substrate. The adhesive spacer can be inserted in between the cutout layer and the contact layer. The method can further comprise the step of applying gel to the cutout area on the contact layer. Furthermore, an adhesive washer can be attached to the cutout on the contact layer. In some embodiments, the method further comprises the step of cutting spiral cuts, the spiral cuts adaptable to surround the cutout. The method provided herein can further comprise more than one cutout on the contact layer and more than one contact on the electronics layer corresponding to the cutouts on the contact layer. Further provided herein is a wireless integrated patch produced according to the above described method. 
     INCORPORATION BY REFERENCE 
     All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference in their entirety. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: 
         FIG. 1  illustrates an expanded view of one embodiment of an integrated patch; 
         FIGS. 2 A -2 E    illustrate one method for fabricating an integrated patch; 
         FIGS. 3 A -3 C    illustrate one method for assembling an integrated patch; and 
         FIG. 4  illustrates a schematic cross-sectional view of one electrode of an integrated patch. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Provided herein is an integrated wireless patch which comprises a contact layer comprising a substrate, an electronic layer folded into contact with the contact layer, and a battery layer folded into contact with the electronic layer. The battery layer comprises battery terminal tabs. Additionally, the battery layer can further comprise at least one antenna. The patch can be adaptable to be assembled by positioning the electronic layer between the contact layer and the battery layer. Furthermore, the patch can comprise an adhesive layer adaptable to be located between the contact layer and the electronic layer. In some embodiments, the patch can further comprise a battery. The contact layer can comprise at least one contact adaptable to be in communication with a surface of a patient. The contact layer can further comprise an adhesive surround positioned around the contact. Additionally, the patch can further comprise at least one antenna. The patch can also comprise at least one application specific integrated circuit (ASIC) on the electronic layer. 
     I. Devices 
       FIG. 1  illustrates the components of a wireless patch. The wireless patch can use a multi-chip module or ASIC to integrate most of the needed functions into a single module. The ASIC can be a single chip device. In some embodiments, additional components can be added to the ASIC as needed. The  FIG. 1  illustrates a substrate comprising a contact layer  1 A, an electronics layer  1 B, and a battery layer  1 C. The contact layer  1 A can come in contact with the surface of a patient. The contact layer can have gel cutouts  9 . The gel cutouts  9  can be filled with a gel  11  that conducts an electrical signal from the surface of the patient. In some embodiments, the gel cutouts  9  can be surrounded by spiral cutouts  8 . The spiral cutout  8  can provide flexibility between the contact layer and the skin of the patient and can serve to reduce strain between the contact layer and the skin surface. In some embodiments, the cutouts  9  of the contact layer  1 A can have adhesive washers  10  that surround the cutouts  9 . An electrode gel  11  can be used in conjunction with the adhesive washers  10  and the cutouts  9  to facilitate communication between the surface of the patient and the contacts  6  on the electronics layer  1 B. 
     The electronics layer  1 B comprises at least one contact pad  6 . In some embodiments, multiple contact pads  6  can be fabricated on the electronics layer  1 B, as shown in  FIG. 1 . The contact pads  6  can have conducting traces  7  that relay the signal sensed by the contact pads  6  to an application specific integrated circuit (ASIC)  3  located on the electronics layer  1 B. The ASIC can be mounted directly on the substrate, with no additional support. 
     A battery can be used to power the patch. The battery can be in communication with the patch through the battery layer. In some embodiments, the battery layer  1 C is a truncated circle, as shown in  FIG. 1 . In some embodiments, the battery layer can be substantially circular. The battery layer  1 C, as shown in  FIG. 1 , can have battery terminals  5  that come in contact with a battery  2 . The battery terminals can be spot welded or conductive glued to the battery layer. A cover or insulating film can be put over the top, with holes left for air access in the case of the battery is a zinc-air battery. The battery  2  powers the ASIC  3  through traces  7  between the battery terminals  5  and the ASIC  3 . Additional support can be provided to the battery. The battery layer can further be adaptable to be used with a flat battery such as, for example purposes only, a watch battery, where the flat battery is mounted directly onto the battery layer. 
     In some embodiments, the battery layer  1 C further comprises an antenna  4  that is in communication with the ASIC  3 . Additionally, an input/output (I/O) used to communicate information from the patch to a user can be included on the battery layer. Input/outputs include, but are not limited to, light emitting diodes (LEDs), switches, or any other suitable indicator or actuator. 
     Additionally shown in  FIG. 1  is an adhesive spacer  12 . The adhesive spacer  12  can be located between the contact layer  1 A and the electronics layer  1 B, in order to prevent signal leakage between electrodes. The adhesive spacer can also be used to add a bit of thickness to keep the application specific integrated circuit projecting out too far from the electronics layer. A cutout  13  can be located on the adhesive spacer  12  to accommodate the ASIC  3  on the electronics layer  1 B. 
     Furthermore gel cutouts  14  of the adhesive spacer  12  can correspond to the gel cutouts  9  and contacts  6  of the contact layer  1 A and the electronics layer  1 B, respectively. 
     II. Methods of Manufacturing 
     Further provided herein is a method of manufacturing a wireless integrated patch comprising the steps of: folding a substrate comprising at least one cutout, at least one contact disk in communication with a surface of a patient through the cutout, and battery terminals, wherein the at least one cutout, the at least on contact, and the battery terminals are adaptable to be located in different layers after the substrate is folded. Additionally, the method can comprise the step of attaching a battery to the battery terminals. Cutouts can be created in the substrate prior to the folding step. Furthermore, the method can further comprise the step fabricating at least one contact on the substrate prior to the folding step. In some embodiments of the method, the method can further comprise the step of attaching an ASIC to the substrate and further comprising the step of connecting the at least one contact to the ASIC with a trace. An antenna can be connected to the ASIC as part of the method. Additionally, an adhesive spacer can be inserted he between two layers of the folded substrate. The adhesive spacer can be inserted in between the cutout layer and the contact layer. The method can further comprise the step of applying gel to the cutout area on the contact layer. Furthermore, an adhesive washer can be attached to the cutout on the contact layer. In some embodiments, the method further comprises the step of cutting spiral cuts, the spiral cuts adaptable to surround the cutout. The method provided herein can further comprise more than one cutout on the contact layer and more than one contact on the electronics layer corresponding to the cutouts on the contact layer. Further provided herein is a wireless integrated patch produced according to the above described method. 
     Provided herein is a method of manufacturing a wireless patch with integrated circuits and a battery. The patch can be manufactured using materials that are disposable or recyclable, while still meeting the technical requirements of the market for example purposes only, size, weight, battery life, functionality, comfort, among others. The process for manufacturing one embodiment of a wireless patch with integrated circuits is described below. While the steps of manufacturing such a wireless patch are outlined in one order, it should be noted that the steps for manufacturing the device can be done in any suitable order. 
       FIGS. 2A-2E  illustrate one method for fabricating a wireless integrate patch.  FIG. 2A  illustrates a patch outline that has been cut from a piece of substrate material  1 . In some embodiments, the substrate  1  is cut such that three separate sections are defined creating a first section  1 A, a middle section  1 B, and an end section  1 C, as shown in  FIG. 2A . The beginning section  1 A corresponds to the contact layer, as described in  FIG. 1 . The middle section  1 B and end section  1 C correspond to the electronics layer and the battery layer, respectively. In some embodiments, the substrate is cut in one continuous strip. The substrate  1  can be cut so that the beginning section  1 A and middle section  1 B are cut in substantially the same shape, as seen in  FIG. 2A . The end section  1 C can be cut so that is only partially the size as the beginning and middle sections, as shown in  FIG. 2A . Alternatively, the end section  1 C can be cut so that the end section is the substantially the same shape as the beginning and middle sections. 
     After the substrate has been cut to the desired shape and/or size, at least one cutout  9  can be formed in the beginning part  1 A of the substrate  1 . The cutout  9  can provide access between a contact disk  6  and the patient&#39;s skin. In some embodiments, multiple cutouts  9  are provided are shown in  FIG. 2B . Additionally, spiral slots  8  can be cut in the substrate  1  surrounding the cutout  9 . The spiral slot  8  can help to alleviate tension between the substrate and the surface of the skin, wherein the tension is caused by slight changes in the surface characteristics of the skin. The spiral slot surrounding the cutout has been previously described in U.S. Ser. No. 60/982,233 filed Oct. 24, 2007, entitled Multi-Electrode Sensing Patch for Long-term Physiological Monitoring with Swappable Electronics, Radio and Battery (Beck). 
     After the cutouts  9  have been formed, at least one contact disk  9  can be fabricated on the surface of the middle section  1 B of the substrate. The contact can be fabricated from metal, polymer, or composite or any suitable combination thereof. The contact can be fabricated by any suitable method including, but not limited to, microfabrication, printing, chemical deposition or other techniques. Multiple contacts can be fabricated on the substrate, as shown in  FIG. 2C . Any suitable number of contacts can be fabricated on the substrate. Traces  7  from the contacts  6  can also be fabricated. In addition to the contacts, battery contact points can be fabricated on the end section of the substrate. 
     After the contacts and traces from the contact have been fabricated, an application specific integrated circuit  3  can be mounted on the substrate  1  as shown in  FIG. 2D . Additionally, an antenna  4  can be mounted on the substrate  1 . Before the device is folded into its final configuration a battery  2  can be attached to the substrate  1  at the battery terminals  5 . The device can be folded after the battery has been attached. Alternatively, the device can be folded and then the battery attached. 
       FIGS. 3A-3C  illustrate a wireless integrated patch being assembled.  FIG. 3A  illustrates a fabricated wireless integrated patch before being assembled. The patch can then be assembled by folding the patch using a z-fold as shown in  FIG. 3B , wherein the contact layer  1 A is in contact with the electronics layer  1 B, and the electronics layer  1 B is in contact with the battery layer  1 C. An adhesive spacer  12  can be inserted in between the contact layer  1 B and the electronics layer  1 C. Once the device is folded as shown in  FIG. 3C , the adhesive washers  10  and gel  11  can be applied to the contact layer  1 A. 
     A schematic cross section of a portion of the patch is shown in  FIG. 4 , in particular the contact layer  1 A and electronics layer  1 B and related structures. As shown in  FIG. 4 , the contact layer  1 A can be stacked on the electronics layer  1 B with an adhesive spacer  12  located in between the contact layer  1 A and the electronics layer  1 B. The contact  6  on the electronics layer  1 B is in communication with the surface of a patient through the gel cutout  9  on the contact layer  1 A and electrode gel  11 . In some embodiments, the contact layer  1 A can be adhered to the skin of a patient using adhesive washers  10  surrounding the get cutout  9  of the contact layer  1 A. Spiral cutouts  8  surrounding the gel cutout  9  can help alleviate any tension between the patch and the skin surface. 
     While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.