News Column

Patent Issued for Interoperability Enhancement That Supports Connectivity of Applications on a Medical Device

June 16, 2014



By a News Reporter-Staff News Editor at Diabetes Week -- According to news reporting originating from Alexandria, Virginia, by NewsRx journalists, a patent by the inventors Halvorson, Christopher R. (Carmel, IN); Long, James R. (Fishers, IN); McKinney, Ryan S. (Brownsburg, IN); Scroggin, Adam R. (Noblesville, IN); Young, Morris J. (Noblesville, IN), filed on October 24, 2011, was published online on June 3, 2014 (see also Roche Diagnostics Operations, Inc.).

The assignee for this patent, patent number 8745298, is Roche Diagnostics Operations, Inc. (Indianapolis, IN).

Reporters obtained the following quote from the background information supplied by the inventors: "Diabetes mellitus, often referred to as diabetes, is a chronic condition in which a person has elevated blood glucose levels that result from defects in the body's ability to produce and/or use insulin. There are three main types of diabetes. Type 1 diabetes usually strikes children and young adults, and may be autoimmune, genetic, and/or environmental. Type 2 diabetes accounts for 90-95% of diabetes cases and is linked to obesity and physical inactivity. Gestational diabetes is a form of glucose intolerance diagnosed during pregnancy and usually resolves spontaneously after delivery.

"In 2009, according to the World Health Organization, at least 220 million people worldwide suffer from diabetes. In 2005, an estimated 1.1 million people died from diabetes. Its incidence is increasing rapidly, and it is estimated that between 2005 and 2030, the number of deaths from diabetes will double. In the United States, nearly 24 million Americans have diabetes with an estimated 25 percent of seniors age 60 and older being affected. The Centers for Disease Control and Prevention forecast that 1 in 3 Americans born after 2000 will develop diabetes during their lifetime. The National Diabetes Information Clearinghouse estimates that diabetes costs $132 billion in the United States alone every year. Without treatment, diabetes can lead to severe complications such as heart disease, stroke, blindness, kidney failure, amputations, and death related to pneumonia and flu.

"Management of diabetes is complex as the level of blood glucose entering the bloodstream is dynamic. Variation of insulin in the bloodstream that controls the transport of glucose out of the bloodstream also complicates diabetes management. Blood glucose levels are sensitive to diet and exercise, but also can be affected by sleep, stress, smoking, travel, illness, menses, and other psychological and lifestyle factors unique to individual patients. The dynamic nature of blood glucose and insulin, and all other factors affecting blood glucose, often require a person with diabetes to forecast blood glucose levels. Therefore, therapy in the form of insulin or oral medications, or both, can be timed to maintain blood glucose levels in an appropriate range.

"Management of diabetes is often highly intrusive because of the need to consistently obtain reliable diagnostic information, follow prescribed therapy, and manage lifestyle on a daily basis. Daily diagnostic information, such as blood glucose concentration, is typically obtained from a capillary blood sample with a lancing device and is then measured with a handheld blood glucose meter. Interstitial glucose levels may be obtained from a continuous glucose sensor worn on the body. Prescribed therapies may include insulin, oral medications, or both. Insulin can be delivered with a syringe, an ambulatory infusion pump, or a combination of both. With insulin therapy, determining the amount of insulin to be injected can require forecasting meal composition of fat, carbohydrates and proteins along with effects of exercise or other physiologic states. The management of lifestyle factors such as body weight, diet, and exercise can significantly influence the type and effectiveness of a therapy.

"Management of diabetes involves large amounts of diagnostic data and prescriptive data that are acquired from medical devices, personal healthcare devices, patient recorded information, healthcare professional tests results, prescribed medications and recorded information. Clinicians generally treat diabetic patients according to published therapeutic guidelines such as, for example, Joslin Diabetes Center & Joslin Clinic, Clinical Guideline for Pharmacological Management of Type 2 Diabetes (2007) and Joslin Diabetes Center & Joslin Clinic, Clinical Guideline for Adults with Diabetes (2008). The guidelines may specify a desired biomarker value, e.g., a fasting blood glucose value of less than 100 mg/dl, or the clinician can specify a desired biomarker value based on the clinician's training and experience in treating patients with diabetes. However, such guidelines do not specify biomarker collection procedures for parameter adjustments to support specific therapies used in optimizing a diabetic patient's therapy. Subsequently, diabetic patients often must measure their glucose levels with little structure for collection and with little regard to lifestyle factors. Such unstructured collection of glucose levels can result in some biomarker measurements lacking interpretative context, thereby reducing the value of such measurements to clinicians and other health care providers. Thus, there is a need to provide structured collection procedures for diagnostic or therapy support of a patient with diabetes or other chronic diseases.

"Patients with diabetes and their healthcare professionals interact with a variety of medical devices and systems to help manage the disease. For each of these differing types of medical devices, there is a need to aggregate, manipulate, manage, present, and communicate diagnostic data and prescriptive data from multiple data sources in an efficient manner to improve the care and health of a person with diabetes, so the person with diabetes can lead a full life and reduce the risk of complications from diabetes. There is also a need to aggregate, manipulate, manage, present, and communicate such diagnostic data and prescriptive data amongst the different types of medical devices using a standard communication protocol.

"Continua Health Alliance is a trade association working toward establishing systems and standards for interoperable medical devices. Design guidelines put forth by Continua leverage various IEEE standards including IEEE 11073 which pertains to the interoperability of personal health devices. In the Continua paradigm, devices take on the lead role in establishing a data connection with other devices. As such, health care management systems operated by healthcare providers must adapt from an initiator role to a 'listening' role. Therefore, it is desirable to provide an interoperability enhancement that supports connectivity of devices in compliance with Continua design guidelines while continuing to support legacy devices. Additionally, the interoperability enhancement should support multiple applications residing on a single device, including contention resolution amongst applications accessing a given data connection.

"The background description provided herein is for the purpose of generally presenting the context of the disclosure."

In addition to obtaining background information on this patent, NewsRx editors also obtained the inventors' summary information for this patent: "A diabetes management system is provided that supports connectivity of applications residing on a medical device. The diabetes management system includes a medical device that performs a diabetes care function in relation to a patient and a diabetes care management device in data communication with the medical device. The diabetes care management device is comprised generally of a connection management module configured to receive an associate request from the medical device and operable to establish a data connection with the medical device in accordance with IEEE standard 11073; as well as at least one application separate from the connection management module, such that the application interacts with the connection management module to communicate via the data connection with the medical device.

"In one aspect of this disclosure, a listing of devices interoperable with the diabetes care management device is made accessible to the connection management module. Upon receipt of an associate request, the connection management module queries the listing of devices and establishes the data connection when the associate request is received from a medical device on the listing of devices. On the other hand, the connection management module operates to disassociate from the medical device when the medical device is not on the listing of devices.

"In an alternative configuration, the listing of devices interoperable with the diabetes care management device is made accessible to the first application. The first application queries the listing of devices and establishes the data connection when the associate request is received from a medical device on the listing of devices.

"In another aspect of this disclosure, the connection management module receives a registration request from the first application for the data connection with the medical device and registers the data connection for use by the first application. The connection management module then receives messages over the data connection from the medical device and routes the messages to the first application.

"The connection management module is further configured to receive data over the data connection from the medical device and store the data for subsequent access by a client application in a transient data store accessible to the connection management module.

"In yet another aspect of this disclosure, the connection management module establishes an inter-process communication (IPC) channel for communication with the first application. The first application operates over the IPC channel to acquire a reference to a remotable object from the connection management module and instantiates the remotable object, where the remotable object exposes methods which allow the first application to communicate with the connection management module. The connection management module may communicate with the first application in accordance with the .NET framework.

"In another aspect of this disclosure, the diabetes management system also supports contention resolution amongst two to more applications residing on a diabetes care management device. In addition to the connection management module, the diabetes care management device includes a first application separate from the connection management module; a second application separate from the connection management module and residing on the diabetes care management device; and a contention manager configured to receive a request to access the data connection from both the first and second application and operable to grant access to one of the first application or the second application in accordance with an access rule.

"Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the disclosure."

For more information, see this patent: Halvorson, Christopher R.; Long, James R.; McKinney, Ryan S.; Scroggin, Adam R.; Young, Morris J.. Interoperability Enhancement That Supports Connectivity of Applications on a Medical Device. U.S. Patent Number 8745298, filed October 24, 2011, and published online on June 3, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8745298.PN.&OS=PN/8745298RS=PN/8745298

Keywords for this news article include: Therapy, Genetics, Proinsulin, Endocrinology, Peptide Hormones, Diabetes Management, Roche Diagnostics Operations Inc..

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Diabetes Week


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