Browse Prior Art Database

Publication Date: 2010-Aug-09
Document File: 3 page(s) / 328K

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The Prior Art Database

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A marker is provided on an implantable lead that allows a clinician to identify an implantable lead as safe or conditionally safe for exposure to magnetic resonance imaging (MRI) environments.  The marker may be comprised of a radiopaque material that is visible using fluoroscopy or other imaging techniques.  The marker may be placed on the lead at the time of manufacture, or may be placed on the lead when a component of the implantable medical device (IMD), such as the pulse generator, is replaced or updated.  The marker can be applied to any type of lead, including, but not limited to, bradycardia, tachycardia, heart failure, and neurostimulation leads.

Magnetic resonance imaging (MRI) is an efficient technique used in the diagnosis of many disorders, including neurological and cardiac abnormalities and other diseases. MRI has achieved prominence in both the research and clinical arenas.  It provides a non-invasive method for examining internal body structures and functions. Because MRI has become such a useful diagnostic tool, it now is used extensively in hospitals and clinics around the world.

The strong electromagnetic fields produced by MRI systems can cause problems for some implantable medical devices, while other implantable medical devices have been designed to be MRI safe or MRI conditionally safe (i.e., safe under certain MRI conditions).  At times, patient implant data and records and/or patient supplied information is/are relied upon to determine whether the patient’s lead is safe for exposure to MRI fields.  However, due to the potential effects of the MRI fields on a lead not designed for MRI exposure, it is important to be able to verify the MRI compatibility of the patient’s lead prior to exposing the lead to the MRI environment.

According to one implementation, a marker 10 that is secured to a lead prior to implantation is illustrated below in FIG. 1.  The marker 10 includes a housing 12 that is secured over the lead such that the housing 12 surrounds the lead.  The housing 12 may include a lumen 14 through which the lead is passed prior to implantation or connection to the pulse generator.  For example, the marker 10 may be slid over the connector on the lead prior to implantation, or added to the lead during production.

The housing 12 also includes one or more radiopaque elements 16 that are embedded in or otherwise mounted to the housing 12.   The radiopaque elements 16 are comprised of a radiopaque material.  For example, the radiopaque elements 16 may be comprised of a radiographic material such as platinum, gold, iridium, palladium, rhenium, rhodium, tungsten, tantalum, silver and tin.  The radiopaque elements 16 may alternatively be comprised of a low durometer polymer in order to render the polymer sufficiently flexible so as not to impair the flexibility of the lead 12.  The housing 12 or radiopaque elements 16 may additionally or alternativ...