Medtronic, Inc.

Ruchika Singhal

Robert M Skime

Carl D Wahlstrand

Mark S Lent

Darren A Janzig

Kenneth Timothy Heruth

Erik R Scott

Paulette C Olson

James E Randall

Michael J Schendel

David Anthnoy Simon

Andrew N Csavoy

Steven J Urquhart

Christopher M Hobot

Gary William King

William Jeffrey Bertrand

Maura G Donovan

Steven L Jensen

Randall V Sparer

William J Hooper

A method and apparatus for optimizing a computer assisted procedure is provided. A method and apparatus for performing a procedure is also provided. Data can be accessed and processed to optimize and perform a procedure. The data can be augmented or supplemented with patient specific data.

Method and apparatus for optimizing a computer assisted surgical procedure

An implantable medical device with lubricious material permits implantable medical devices to have a reduced friction between the device and at least a portion of the surrounding tissue. The implantable medical device may have a housing or it may have a housing and a member for providing a smooth interface between the device and the tissue. The lubricious material may be provided on or impregnated in the housing or the member. In some embodiments, the device is configured for implantation in the head of a human body. In other embodiments, the device is configured for implantation between the cranium and the scalp. In some embodiments, the device includes a single module while in other embodiments a plurality of modules are coupled together to provide a smaller profile.

Implantable medical device with lubricious material

Implantable medical devices (IMDS) having anti-infective properties are described. Anti-infective agents are disposed in, on, or about at least a portion of a surface of the medical device. The anti-infective agents are disposed in or on a vehicle, which may be in the form of a coating layer or covering. The vehicle may be biodegradable so that, over time, the anti-infective agent is removed from a tissue location into which the device is implanted, reducing the likelihood that microorganisms resistant to the anti-infective agent will develop. IMDs having an anti-infective agent and an anti-activity agent disposed therein, thereabout, or thereon are also described. The anti-activity agent interferes with the activity of the anti-infective agent, may be released from a surface at the IMD at a time when activity of the anti-infective agent is no longer desired, and may reduce the likelihood that microorganisms resistant to the anti-infective agent will develop.

Anti-infective medical device

In general, the invention is directed to techniques for implantation of a low-profile implantable medical device (IMD) in the body of a patient. In an exemplary embodiment, the low-profile IMD is implanted under the scalp. When the treatment or monitoring site is in or on the head of the patient, the low-profile IMD can be implanted under the scalp proximate to the treatment or monitoring site. In one embodiment, the invention is directed to a method that includes making an incision in the scalp of a head of a patient to create a scalp flap, exposing a skull beneath the scalp flap, creating a pocket between the scalp and the skull, and placing at least a portion of a low-profile IMD in the pocket. The low-profile IMD may include a plurality of modules, covered in part by a flexible overmold.

Implantation of low-profile implantable medical device

A medical device detects a previously defined event, and controls delivery of therapy to a patient according to therapy information associated with the previously defined event. In exemplary embodiments, the medical device enters a learning mode in response to a command received from a user, e.g., the patient or a clinician. In such embodiments, the medical device defines the event, collects the therapy information, and associates the therapy information with the defined event while operating in the learning mode. In some embodiments, the medical device defines the event based on the output of a sensor that indicates a physiological parameter of the patient during the learning mode. The sensor may be an accelerometer, which generates an output that reflects motion and/or posture of the patient. The medical device may collect therapy information by recording therapy changes made by the user during the learning mode.

Automatic therapy adjustments

In general, the invention is directed to strategies pertaining to implantation of an implantable medical device between a scalp and a skull of the patient. The invention pertains to collection of data such as data pertaining to the skull of the patient, the scalp of the patient, the vascular structure or neurological structures in the head of the patient, and the like. The data may be in the form of images, such as images generated by X-ray, magnetic resonance imaging, CT-scan and fluoroscopy. A surgeon can use the collected data to determine, for example, whether the patient is a candidate for a cranial implantation, whether the patient's skull and scalp can support the implantation, what configuration of device should be implanted, where the device should be implanted, and how the surgical incisions should be made.

Evaluation of implantation site for implantation of implantable medical device

Systems and methods for coordinated delivery of a therapeutic agent and low (less than about 20 Hz) and high (greater than about 50 Hz) frequency stimulation therapy are described. The systems include a control unit for coordinating therapy delivery between an infusion device and a pulse generator, such that a therapeutic agent is administered at a predetermined time relative to application of either low frequency or high frequency stimulation. For example, the control unit may instruct the infusion device to deliver therapeutic agent at a predetermined time prior to delivery of low frequency stimulation. Systems that include more than one infusion device or an infusion pump capable of delivering more than one therapeutic agent are also described.

Regional therapies for treatment of pain

An implantable medical device comprises an anti-infection agent. The implantable medical device may be configured for placement in the head of a patient and for monitoring or treatment of the brain. The implantable medical device may have a housing or it may have a housing and a member for providing a smooth interface between the device and the adjacent tissue. The anti-infection agent may be provided on or impregnated in the housing or the member. In some embodiments, the device includes a single module while in other embodiments a plurality of modules are coupled to provide a smaller profile. In some embodiments the implantable medical device may include both anti-infection and lubricious materials.

Implantable medical device with anti-infection agent

Enhanced therapies for treating pain are described. The therapies include subcutaneous stimulation of tissue in proximity to a source of pain at low frequencies (less than about 20 Hz) and high frequencies (greater than about 50 Hz). The therapies further include administering a pain treating agent at a predetermined time relative to application of the high or low frequency stimulation. Delivery of the pain treating agent via an implantable infusion system is described. Coordination of output of an infusion device and a pulse generator to provide coordinated therapy is also discussed.

Enhanced therapies for treating pain are described. The therapies include subcutaneous stimulation of tissue in proximity to a source of pain at low frequencies (less than about 20 Hz) and high frequencies (greater than about 50 Hz). The subcutaneous stimulation may be applied in proximity to a structure in the back, such as discs, facet joints, nerve roots or ganglions, sympathetic chain, ligaments, muscles, and the like. Subcutaneous stimulation at high and low frequencies applied in combination with epidural stimulation is also described.

An implantable medical device with anti-infection agent. The implantable medical device may be configured for placement in the head of a patient and for monitoring or treatment of the brain. The implantable medical device may have a housing or it may have a housing and a member for providing a smooth interface between the device and the adjacent tissue. The anti-infection agent may be provided on or impregnated in the housing or the member. In some embodiments, the device includes a single module while in other embodiments a plurality of modules are coupled to provide a smaller profile. In some embodiments the implantable medical device may include both anti-infection and lubricious materials.

Implantation of implantable medical device

At least one surface of an implantable medical device is concave along at least one axis such that it substantially conforms to a surface within a patient, such as the cranium, when it is implanted on that surface. In some embodiments, the surface of the implantable medical device substantially conforms to an arc with a radius that is between 4.5 and 9.5 centimeters, and is preferably approximately equal to 7 centimeters. In some embodiments, the implantable medical device comprises a plurality of interconnected modules, and an overmold that at least partially encapsulates each of the modules. In such embodiments, at least one surface of the overmold is concave along at least one axis. Further, each of the modules of such an implantable medical device may comprise a housing, and at least one surface of at least one of the housings may be concave along at least one axis.

Concavity of an implantable medical device

A modular implantable medical device permits implantable medical devices to have a smaller profile in order to better fit into locations within the human body. A modular implantable medical device separates various functional components of the implantable medical device into a set of interconnected modules. This distributed architecture of a modular implantable medical device may permit the device footprint to be distributed over a larger area while making the profile smaller, and may permit the overall shape of the implantable medical device to better match the body location into which it is to be implanted. An overmold integrates the modules of a modular implantable medical device into a single structure. In some embodiments the overmold is flexible and provides a biocompatible interface from the component modules and the patient, while restraining potentially harmful intermodule motion.

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Minneapolis, MN, United States of America

Ruchika Singhal