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MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT (Real Time) series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention. 〔http://www.cbsnews.com/stories/2003/07/08/tech/main562162.shtml〕〔http://www.insulin-pumpers.org/faq/rv511.html〕 In the United States, the device is regulated by a branch of the Food and Drug Administration.〔https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K053177〕 ==Description== Insulin pumps are drug delivery devices used to treat patients with type 1 and type 2 diabetes. The Minimed Paradigm REAL-Time and Continuous Glucose Monitoring (CGM) system, which received FDA clearance in 2006,〔http://www.highbeam.com/doc/1G1-144423779.html〕 uses tubing and a reservoir with rapid-acting insulin. This "infusion set" is patient-connected via a catheter to the abdomen region. The infusion set can remain in the place for 3 days while the pump is clip-belt worn. There is a quick-disconnect feature for the tubing. The pump delivers insulin in two modes. In Basal rate mode, the delivery is continuous in small doses similar to a pancreas, for example 0.15 units per hour throughout the day. Basal rates are set to meet individual metabolic rates. In Bolus mode, the delivery is programmed to be a one-time delivery prior to eating or after an unexpected high, for example 18 units spread out to several hours. This type of continuous treatment is in contrast to traditional multiple daily injections (MDI) that use slower-acting insulin. Continuous treatment reduces glucose variability.〔https://www.bcbsal.org/providers/policies/final/046.pdf〕 The Paradigm system consists of two basic parts: an insulin pump and an optional glucose sensor CGM worn for up to 3 days. The disposable sensor is subcutaneously-placed to make glucose measurements〔http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=54140〕 in interstitial fluid every 5 minutes and transmit the reading via low power radio frequency (ISM band) to the pump for realtime display. However, insulin therapy may be conducted without CGM and although there is not yet an automated insulin-regulation feedback mechanism between measure and infusion to control the amount and timing of insulin, this is clearly a future objective. So any change in basal or bolus is patient-driven by programming the pump using the Bolus WizardTM. The latest model pumps are the MiniMed Paradigm 522 and 722 which differ in reservoir size, 176 versus 300 units, respectively. In 2007 the FDA approved a pediatric model for patients 7 to 17 years old.〔http://www.ingentaconnect.com/content/adis/end/2003/00000002/00000001/art00002?crawler=true〕 The Minimed Paradigm System is composed of the following parts: *Insulin pump models 522/722 *Glucose sensor kit (CGM) *Minilink RF transmitter *Infusion set and reservoirs *CareLink USB upload device *CareLink therapy management software〔http://www.medtronic-diabetes.com.au/medical_prof-paradign-pal.html〕 In addition to system parts, there are other necessary parts associated with overall diabetes therapy including a glucose meter for finger stick calibrations and treatment verification, traditional injectors and supplies, ketones test supplies, test strip vials, skin preparation, glucagon supplements, etc. If using OneTouch UltraLink meter, readings are sent wirelessly to the pump.〔http://www.medtronicdiabetes.com/products/insulinpumps/components/index.html〕 The development history of the Minimed pump goes back to the 1980s.〔http://www.minimed.com/about/history.html〕 *1983 – 1st Pump MiniMed 502 (Eli Lilly makes synthetic insulin〔http://www.accessexcellence.org/RC/AB/BC/1977-Present.php〕) *1985 – MiniMed 504 Insulin Pump *1992 – Launch Of MiniMed 506 Insulin Pump *1996 – Introduction of MiniMed 507 Pump *1999 – Launch of the Model 507C *1999 – Introduction of MiniMed 508 Insulin Pump *2002 – Inauguration of the MiniMed Paradigm 511 *2003 – 1st Wireless MiniMed Paradigm 512/712 (followed by 515/715) *2006 – MiniMed Paradigm REAL-Time 522/722 *2010 – MiniMed Paradigm REAL-Time Revel 523/723〔http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1268411129675&lang=en_US〕 The Food and Drug Administration has at least six classifications for the various parts of the Minimed Paradigm System. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Minimed Paradigm」の詳細全文を読む スポンサード リンク
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