The Momentum Continues

The topic of consumer medical apps coming to market for smartphones, smartwatches and Google Glass-like devices over the next few years is currently one of the hottest in the industry.

ABI Research posted a report on Thursday with their byline being "Ninety Million Wearable Computing Devices Will Be Shipped in 2014 Driven by Sports, Health and Fitness." Then on Friday 9to5Mac posted a report about iOS 8 introducing "Healthbook," an app that will have the ability to monitor a user's vital signs – which brings us to today's patent discovery. The following is an overview of a very sophisticated invention concerning a portable physiological parameter detection and monitoring system for the iPhone.

Patent Background

Atrial fibrillation (AF) is a cardiac arrhythmia, i.e. an altered electrical activity (irregular or faster or slower than normal) of the heart that involves the atria, and is an example of one type of cardiac rhythm that would benefit from remote monitoring. AF may be detected as irregularities when taking a pulse. Rhythm disturbances i.e. arrhythmias are common, and often asymptomatic so called "silent" which at times may be life threatening. Accurate detection and diagnosis is warranted as well as monitoring. AF is the most common form of arrhythmia affecting approximately 3-5% of people over 65 and 8% of people over 80. For example, there are about 2.2 million cases in the U.S. yearly. It is a highly prevalent disease associated with significant cardiovascular morbidity and mortality. AF represents 34% of hospitalizations in the U.S. for arrhythmias annually. It is estimated that the annual cost to the U.S. Medicare system alone is more than $15.7 billion due to cost complications. However, screening and diagnosis is limited in the Medicare population. By 2015, it is projected that 15 million Americans will suffer from AF and its adverse consequences.

In AF, the electrical impulses that are normally generated by the sinoatrial node (the sinus node) are replaced by disorganized activity in the atria, leading to irregular conduction of impulses to the ventricles that generate the heartbeat. This results in irregular heartbeats. AF may be continuous (persistent or permanent AF) or alternating between periods of normal heart rhythm (paroxysmal AF). Over time, the natural tendency of AF is to become continuous/chronic. The type of AF considered to be most dangerous is paroxysmal AF because the recurrent onsets and offsets of fibrillation increase the probability of embolization significantly. During an AF episode, the blood is rather stationary in the atria and coagulation forming blood clots may take place. When the activity then returns to normal, the clots are propelled out into the cardiovascular system, potentially causing strokes etc. Further, paroxysmal AF is the type of AF that normally occurs first, i.e. it is rather unusual that a healthy subject immediately enters chronic AF. AF is a rhythm disturbance having many etiologies (causes) which include, for example, high blood pressure, diabetes, heart failure, etc. In particular AF is a common complication of heart failure. On the other hand AF in the long run may also cause or precipitate heart failure, therefore a timely detection and management is critical.

It should also be noted that out-patients with AF typically also have heart disease (about 65%). More alarmingly, though, is that AF is also associated with silent stroke, dementia and Alzheimer's disease. Stroke affects about 795,000 people annually in the U.S. (about 1 stroke every 40 seconds) and is the third leading cause of death and the number one cause of disability.

There remains a need for an improved device and method for early and convenient detection of AF and for portable and convenient devices capable of monitoring a cardiac rhythm.

Apple iPhone with Physiological Parameter Detection

The current disclosure provides for a low profile portable detection device adapted and configured to obtain a physiological parameter from a mammal and either store the captured signals on a mobile device, such as a cell phone, smart phone or transmit the data via a communication network such as LAN, WAN and Wifi, mWifi, radio frequency (RF) or any other wireless medium to another location.

The detection device can also be configured to include a storage disk, a logic device, software, a power source, and one or more chips such as a wireless communication chip which can be adapted and configured to be in communication with, for example, a smart phone (iPhone or similar smart phone device) and/or a communication network and a GPS chip. Communication can be made with any device capable of detecting and capturing one or more physiological parameters. Physiological parameters include, but are not limited to, impedance, cardiac rhythm disturbances e.g., arrhythmias that are common, and often asymptomatic so called "silent" which at times may be life threatening, pulse and/or any other desired physiological parameter. Other physiological characteristics include temperature, respiration, blood pressure, vasomotor activity, physical activity, and body position. The physiological parameter detection device can be adapted and configured to also monitor one or more physiological parameters (e.g., impedance, heart rhythm and/or pulse) over a period of time, both on a long-term basis and an intermittent basis. The detection devices can operate on a standalone basis or as part of a communication network. The detection devices can be configured to be re-usable.

An aspect of the disclosure is directed to a detection device adapted to capture a physiological parameter. Detection devices comprise: a transparent film with an insulating upper surface and a lower surface characterized in that it is removeably adherable; two or more conductive elements wherein at least two conductive elements of the two or more conductive elements are bipolar electrodes, in electrical communication with the removeably adherable lower surface and electrically isolated by the insulating upper surface. Detection devices typically include two or more conductive elements. The two or more conductive elements can further be configured to include a first elongated conductive element and a second elongated conductive element, electrically separated from the first elongated conductive element.

Patent FIGS. 1A and 1B and 1E and 1F noted above illustrate a variety of configurations suitable for a detection device such as an iPhone. The detection device is formed from a protective transparent film 102 having a first side 104 and a second side 106 two or more electrodes 110,110'. The electrodes can be added to the film during the manufacturing process. Electrodes can be made of any suitable conductive material including, but not limited to aluminum, copper, silver and gold.

In some configurations, the first elongated conductive element and a second elongated conductive element are configurable within the film such that they are one or more of positioned at opposing ends of the film, parallel each other in a plane, and/or have a shape selected from the group comprising elongated, bracket, and curved. In other configurations, the detection device can further be configured to have one or more of computer memory, microchip, connector, power source, GPS chip, WiFi chip, communication chip.

Another aspect of the disclosure is directed to a method for monitoring a physiological parameter. The method comprises: providing a detection device having a transparent film with an insulating upper surface and a lower surface characterized in that it is removeably adherable, two or more conductive elements wherein at least two conductive elements of the two or more conductive elements are bipolar electrodes, in electrical communication with the removeably adherable lower surface and electrically isolated by the insulating upper surface; placing the film in contact with a mammalian surface having one or more detectable physiological characteristics; acquiring one or more detectable physiological characteristics; and at least one of storing the one or more detectable physiological characteristics on a memory and transmitting the one or more detectable physiological characteristics to another location. The method can also include the step of activating the step of acquiring the one or more detectable physiological characteristics.

Communicating with a Health Facility

In some configurations, the step of transmitting the one or more detectable physiological characteristics can further include transmitting the one or more detectable physiological characteristics to one or more of a hospital, a rhythm monitoring center, and a doctor's office, an electronic device, and a computer. Additionally, the method can include the step of activating a software application associated with an electronic device. In at least some aspects the detectable physiological characteristics are one or more of impedance, heart rhythm and/or pulse. Other physiological characteristics include temperature, respiration, blood pressure, vasomotor activity, physical activity, and body position.

As noted above in patent FIGS. 5A-B we see representations of a physiological parameter detection device in use. As illustrated in FIG. 5A, a user places the detection device or an electronic device having a detection device associated therewith in contact with a skin surface (shown here as the chest below the clavicle bone) to sense one or more physiological parameters (e.g., impedance, heart rhythm and/or pulse). Other physiological characteristics can also be detected including, for example, temperature, respiration, blood pressure, vasomotor activity, physical activity, and body position.

As illustrated in FIG. 5B, a user can alternatively activate the device by touching the device with both hands. For the configuration of FIG. 1, when in use, the film is positioned on a surface of the electronic device and then the combination of the electronic device and film is, for example, held by a user wherein the physiological parameter is detection by the electronic device through the use of the electronics of the film.

Yet another aspect of the disclosure is directed to a networked apparatus. The networked apparatus comprises: a memory; a processor; a communicator; a display; and a detection device having a transparent film with an insulating upper surface and a lower surface characterized in that it is removeably adherable, two or more conductive elements wherein at least two conductive elements of the two or more conductive elements are bipolar electrodes, in electrical communication with the removeably adherable lower surface and electrically isolated by the insulating upper surface.

The SMS Engine

Still another aspect of the disclosure is directed to a communication system. The communication system of the disclosure comprises: a detection device having a transparent film with an insulating upper surface and a lower surface characterized in that it is removeably adherable, two or more conductive elements wherein at least two conductive elements of the two or more conductive elements are bipolar electrodes, in electrical communication with the removeably adherable lower surface and electrically isolated by the insulating upper surface; a server computer system; a measurement module on the server computer system for permitting the transmission of a measurement from a detection device over a network; at least one of an API engine connected to at least one of the detection device to create a message about the measurement and transmit the message over an API integrated network to a recipient having a predetermined recipient user name, an SMS engine connected to at least one of the system for detecting physiological parameters and the detection device to create an SMS message about the measurement and transmit the SMS message over a network to a recipient device having a predetermined measurement recipient telephone number, and an email engine connected to at least one of the detection device to create an email message about the measurement and transmit the email message over the network to a recipient email having a predetermined recipient email address. A storing module on the server computer system for storing the measurement in a detection device server database can also be provided. In some system configurations, the detection device is connectable to the server computer system over at least one of a mobile phone network and an Internet network, and a browser on the measurement recipient electronic device is used to retrieve an interface on the server computer system.

The Rhythm App

In still other configurations, the system further comprising: an interface on the server computer system, the interface being retrievable by an application on the mobile device.

Additionally, the server computer system can be configured such that it is connectable over a cellular phone network to receive a response from the measurement recipient mobile device. The system can further comprise: a downloadable application residing on the measurement recipient mobile device, the downloadable application transmitting the response and a measurement recipient phone number ID over the cellular phone network to the server computer system, the server computer system utilizing the measurement recipient phone number ID to associate the response with the SMS measurement. Additionally, the system can be configured to comprise: a transmissions module that transmits the measurement over a network other than the cellular phone SMS network to a measurement recipient user computer system, in parallel with the measurement that is sent over the cellular phone SMS network.

At the end of the day, the system presented in Ansari's patent could only come to fruition if implemented at the manufacturing stage of the iPhone. Apple would never do that unless they owned the patent.

On Thursday it was clearly established that Ansari is now working with Apple via the financial system patent application. What we don't know at the moment with all certainty is Ansari's true connection to Apple. Is he now on team Apple as an engineer or medical consultant or did Apple simply acquire Ansari's patent(s).

Either way, the revelation of this invention shows us that Apple is considering many approaches for their future medical application(s), via the iPhone and/or other possible devices. Until we get to the granted patent stage, it will remain a bit of an unsolved mystery as to whether Apple has taken assignment of Ansari's other invention. Yet with Apple taking assignment of Ansari's financial system invention as witnessed on Thursday, the odds are high that this current medical app is now under Apple's control.

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