Abstract: One embodiment of the present invention relates to an implantable medical device (“IMD”) that can be programmed from one operational mode to another operational mode when in the presence of electro-magnetic interference (“EMI”). In accordance with this particular embodiment, the IMD includes a communication interface for receiving communication signals from an external device, such as a command to switch the IMD from a first operation mode to a second operation mode. The IMD further includes a processor in electrical communication with the communication interface, which is operable to switch or reprogram the IMD from the first operation mode to the second operation mode upon receiving a command to do so. In addition, the IMD includes a timer operable to measure a time period from when the processor switches the IMD to the second operation mode.

Abstract: A cardiac lead comprising a lead body extending from a proximal end portion to a distal end portion; a cardiac electrode disposed along the lead body; and a coating associated with at least a portion of the electrode, wherein the coating comprises a conductive polymer.

Abstract: A cardiac lead comprising a lead body extending from a proximal end portion to a distal end portion; a cardiac electrode disposed along the lead body; and a coating associated with at least a portion of the electrode, the coating comprises a conductive polymer.

Abstract: A lead includes a lead body extending from a lead proximal end portion to a lead distal end portion and having an intermediate portion therebetween, one or more tissue sensing/stimulation electrodes disposed along the lead body, one or more terminal connections disposed along the lead proximal end portion. The lead further includes one or more conductors contained within the lead body extending between the tissue sensing/stimulation electrodes and the terminal connections, and a fibrous matrix coating is disposed onto at least a portion of the lead body and/or sensing/stimulation electrodes.

Abstract: In accordance with various aspects of the invention, copolymers comprising styrene and isobutylene monomers are used in the construction of implantable and insertable medical devices for electrical stimulation, including, for example, electronic signal generating components and electrical leads for such devices.

Abstract: A medical electrical lead comprises a flexible, elongate lead body extending along a longitudinal axis and having a proximal end and a distal end. A protective distal tip structure is disposed on the distal end of the lead body. The tip structure includes a plurality of compliant projections each extending distally from the distal end of the body in the direction of the longitudinal axis. The projections are configured to contact and bear against cardiac tissue when the lead is implanted, and are deformable under the action of an axially or radially directed force. The projections optionally include a coating over a substrate. The coating can include a hydrogel material and/or a pharmaceutical agent such as a steroid for reducing inflammation at the implantation site.

Abstract: The present invention pertains to polyisobutylene urethane, urea and urethane/urea copolymers, to methods of making such copolymers and to medical devices that contain such polymers. According to certain aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment, an additional polymeric segment that is not a polyisobutylene segment, and a segment comprising a residue of a diisocyanate. According to other aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment and end groups that comprise alkyl-, alkenyl- or alkynyl-chain-containing end groups.

Abstract: The present invention pertains to polyisobutylene urethane, urea and urethane/urea copolymers, to methods of making such copolymers and to medical devices that contain such polymers. According to certain aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment, an additional polymeric segment that is not a polyisobutylene segment, and a segment comprising a residue of a diisocyanate. According to other aspects of the invention, polyisobutylene urethane, urea and urethane/urea copolymers are provided, which comprise a polyisobutylene segment and end groups that comprise alkyl-, alkenyl- or alkynyl-chain-containing end groups.

Abstract: Embodiments of the invention are related to optical window assemblies for implantable medical devices, amongst other things. In an embodiment, the invention includes an optical window assembly for a medical device. The assembly can include a ferrule defining an aperture and a spacer ring disposed within the aperture. The assembly can also include an optical window coupled to the metal ferrule and the spacer ring. In an embodiment, the invention includes an implantable medical device including a housing and an optical window assembly coupled to the housing. In an embodiment, the invention can include a method of manufacturing a medical device. The method can include brazing a spacer ring to a metal ferrule, coupling an optical window to the spacer ring and the metal ferrule with a bonding glass material, depositing a chemical sensing element over the optical window, and coupling a porous cover layer to the spacer ring and the ferrule with an adhesive. Other embodiments are also included herein.

Abstract: One embodiment of the present invention relates to a telemetry device which is in communication with an MRI system, and which is operable to communicate with an implantable medical device (IMD). The telemetry device includes a controller and telemetry circuitry. In one embodiment, the telemetry device is operable to automatically detect the presence of an IMD, and determine if the IMD is in an MRI-safe mode. If the IMD is not in an MRI-safe mode, the telemetry device can initiate processing to prevent the MRI system from conducting an MRI scan while the IMD in not in an MRI-safe mode.

Abstract: One embodiment of the present invention relates to an implantable medical device (“IMD”) that can be programmed from one operational mode to another operational mode when in the presence of electro-magnetic interference (“EMI”). In accordance with this particular embodiment, the IMD includes a communication interface for receiving communication signals from an external device, such as a command to switch the IMD from a first operation mode to a second operation mode. The IMD further includes a processor in electrical communication with the communication interface, which is operable to switch or reprogram the IMD from the first operation mode to the second operation mode upon receiving a command to do so. In addition, the IMD includes a timer operable to measure a time period from when the processor switches the IMD to the second operation mode.

Abstract: A medical electrical lead includes a drug eluting coating provided over at least a portion of the lead body. The drug eluting coating can be provided over at least a portion of the lead body and adjacent to at least one electrode located on the lead body. The drug eluting coating can include at least one matrix polymer layer including a polymer admixed with a therapeutic agent. The therapeutic agent, for example, can be an anti-proliferative agent or an anti-inflammatory agent. The matrix polymer can include a medical adhesive. The rate of elution of the drug from the matrix polymer layer is affected by the drug to polymer ratio of the drug in the matrix polymer layer.

Abstract: Disclosed herein, among other things, are high surface area electrodes and methods of making the same. In an embodiment, the invention includes a method of increasing the surface area of an electrode of an implantable medical device including immersing the electrode in an electrolyte solution and oxidatively removing material from the surface of the electrode. In an embodiment, the invention includes a method of increasing the surface area of an electrode of an implantable medical device including immersing the electrode in an electrolyte solution and applying an oscillating electrical potential. In an embodiment, the invention includes a method of manufacturing an implantable stimulation lead including welding an electrode to a conductor and increasing the surface area of the electrode by oxidatively removing a portion of the electrode surface. Other aspects and embodiments are provided herein.

Abstract: An electrode includes a titanium substrate with a surface including an implanted layer of titanium oxy-nitride compounds.

Abstract: An implantable lead comprises a lead body extending from a lead proximal end portion to a lead distal end portion. In one example, the lead body may comprise a heat-formed bias portion. In another example, an outer insulator is fused to the lead body. In such an example, a lead body fusable plug may be disposed distal to at least one conductor. In another example, the lead comprises an inner boot and an outer boot fused to one another. In another example, the lead includes an atraumatic tip fused to the lead distal end portion. In another example, the lead body is reducable in size using heat shrink tubing. In yet another example, two or more lead sections may be interconnected using an outer insulator fused to the respective lead bodies. In a further example, a stiffener member is fused to the lead body adjacent a lead component.

Abstract: A header assembly for coupling a cardiac lead to a cardiac stimulator is provided. The header assembly includes a header that has a bore for receiving one end of the cardiac lead. The bore has a first longitudinal axis. A connector housing is coupled to the header and has a second bore substantially aligned with the first bore. A biasing member is disposed within the connector housing and has a portion projecting into the second bore to bias the end of the cardiac lead against the walls of the second bore. A set-screw is threadedly coupled to the housing and is operable to secure the cardiac lead to the connector housing when tightened.

Abstract: An implantable cardiac stimulation system having a patient warning system and an elongated electrode mounted near the can of the system for providing reliable stimulation for warning. The electrode has an extended length and a short width. The length is preferably at least double the width and more preferably at least four times the width. This extended length increases the probability that contact with the surrounding tissue will be achieved. The short width and rounded profile of the width, forming an "edge", on the other hand, increases the probability that a high enough current density will be achieved, causing stimulation to occur. The electrode may also be curved along its length, which tends to promote a "point" or small area contact between the electrode and the patient's tissue. The electrode may be mounted directly on the can or header of the cardiac stimulator or may be part of a separate pin electrode.