Medtronic, Inc.

Spencer M Bondhus

Richard T Stone

James M Olsen

Mark J Conroy

Michael Robert Klardie

Timothy R Abraham

Chad Qingshen Cai

Bryan D Stem

Michael J Kern

Brian T Stolz

Bruce R Mehdizadeh

John D Welter

Patrick D Wells

Niklaus Schneeberger

Walter Doell

Guillaume Schmit

Steven M Goetz

Jamu Alford

Michael T Hegland

Jay K Lahti

Mark J Holle

Ashish Singal

Gary W Salminen

Michael Kalm

Mark J Conway

Connector assemblies that are separate from medical lead extensions provide features such as bores for receiving both a medical lead and a medical lead extension and provide electrical connections between connectors of the leads and connectors of the lead extensions. Connector assemblies may include additional features such as contours and wings that reduce subcutaneous erosion. Connector assemblies may also include retention structures such as movable clips that are moved into engagement with leads and lead extensions to retain them within the connector assembly. Integrated lead extension connectors may also include contours and wings as well as retention structures including movable clips.

Connector assemblies for receiving implantable medical leads

Medical lead bodies that are paired each include a braided conductive shield. The braided conductive shield of one lead body has a value for a physical parameter that differs from a value for the physical parameter of the second lead body. The difference in values of the physical parameter for the paired lead bodies results in a reduction in heating from exposure of the lead bodies to radiofrequency energy at electrodes associated with the lead bodies. The lead bodies may be paired by being implanted adjacently to one another. The lead bodies may be further paired by being coupled to a same distal body, such as a paddle containing the electrodes.

Paired medical lead bodies with braided conductive shields having different physical parameter values

A shield located within an implantable medical lead may be terminated in various ways at a metal connector. The shield may be terminated by various joints including butt, scarf, lap, or other joints between insulation layers surrounding the lead and an insulation extension. The shield may terminate with a physical and electrical connection to a single metal connector. The shield may terminate with a physical and electrical connection by passing between an overlapping pair of inner and outer metal connectors. The metal connectors may include features such as teeth or threads that penetrate the insulation layers of the lead. The shield may terminate with a physical and electrical connection by exiting a jacket of a lead adjacent to a metal connector and lapping onto the metal connector.

Termination of a shield within an implantable medical lead

Strain relief loop holders maintain the strain relief loop formed in a lead while also addressing the excessive heating at the point in the loop where the medical lead intersects with itself. The strain relief loop includes a body section that the medical lead passes through where the intersection occurs. The body section may be a thermal non-conductor and isolate from excessive heating at the intersection point or may be a thermal conductor and distribute the excessive heating. The strain relief loop may include features such as arms or a coil extending from the body segment with arm segments at the ends of the arms defining lead passageways that assist in maintaining the strain relief loop. The body segment may have a single lead passageway where the intersection point occurs or may have multiple lead passageways. The body itself may house the loop by forming a loop or a capsule.

Strain relief loop holders for medical leads and systems

Implantable medical systems include implantable medical leads that have magnetic orientation-independent magnetically actuated switches that are placed in the conduction path to the electrode of the lead. Thus, regardless of the orientation of a substantial magnetic field like that from an MRI machine to the lead and switch within the lead, the switch opens when in the presence of that substantial magnetic field. The switch may be placed in close proximity to the electrode such that the opening of the switch disconnects the electrode from the majority of the conduction path which thereby produces a high impedance for RF current and reduces the amount of heating that may occur at the electrode when in the presence of substantial levels of RF electromagnetic energy as may occur within an MRI machine.

Implantable medical leads, systems, and related methods for creating a high impedance within a conduction path in the presence of a magnetic field of a given strength

A shield located within an implantable medical lead may be terminated in various ways. The shield may be terminated by butt, scarf, lap, or other joints between insulation layers surrounding the lead and an insulation extension. For lap joints, a portion of an outer insulation layer may be removed and a replacement outer insulation layer is positioned in place of the removed outer insulation layer, where the replacement layer extends beyond an inner insulation layer and the shield. The replacement layer may also lap onto a portion of the insulation extension. Barbs may be located between the replacement layer and the inner insulation layer or the insulation extension. The shield wires have ends at the termination point that may be folded over individually or may be capped with a ring located within one of the insulation layers of the jacket.

An implantable medical lead has a torsional stiffness and is rotationally coupled to a stylet. Applying rotation directly to the lead in turn causes rotation of the stylet. Where the stylet has a bent tip for purposes of steering the lead, the rotation applied to the lead rotates the bent tip so that the lead can be steered by rotating the lead rather than rotating a hub of the stylet. The rotational coupling may be achieved through one or more features provided for the lead and/or the stylet, such as a feature within a lumen of the lead that mates to a feature along the stylet or a feature of the stylet hub that engages the proximal end of the lead. The torsional stiffness of the lead may be provided by adding a feature within the lead body, such as a braided metal wire or an overlapping foil.

Steering an implantable medical lead via a rotational coupling to a stylet

Conductors within an implantable medical lead that carry stimulation signal signals are at least partially embedded within a lead body of the medical lead over at least a portion of the length of the conductors while being surrounded by a radio frequency (RF) shield. A space between the shield and the conductors is filled by the presence of the lead body material such that body fluids that infiltrate the lead over time cannot pool in the space between the shield and the conductors. The dielectric properties of the lead body are retained and the capacitive coupling between the shield and the conductors continues to be inhibited such that current induced on the shield is inhibited from being channeled onto the conductors. Heating at the electrodes of the medical lead is prevented from becoming excessive.

Devices, systems and methods to reduce coupling of a shield and a conductor within an implantable medical lead

Radiopaque markers represent that a lead is suitable for a particular medical procedure such as a magnetic resonance image scan and are added to the lead or related device. The markers may be added after implantation of the lead in various ways including suturing, gluing, crimping, or clamping a radiopaque tag to the lead or to the device. The markers may be added by placing a radiopaque coil about the lead, and the radiopaque coil may radially contract against the lead to obtain a fixed position. The markers may be added by placing a polymer structure onto the lead where the polymer structure includes a radiopaque marker within it. The polymer structure may include a cylindrical aperture that contracts against the lead to fix the position of the structure. The polymer structure may form a lead anchor that includes suture wings that can be sutured to the lead.

Radiopaque markers for implantable medical leads, devices, and systems

In some examples, a burr hole cap assembly includes one or more markers that indicate a rotational orientation of a therapy delivery member relative to the burr hole cap assembly, where the therapy delivery member extends through an opening defined by the burr hole cap assembly. In addition, in some examples, the burr hole cap assembly includes a feature that indicates the rotational orientation of the therapy delivery member after the therapy delivery member is implanted in the patient. The feature can include the one or more markers in some examples.

Burr hole cap assembly with therapy delivery member orientation feature

Strain relief loop holders maintaining strain relief loop formed in a lead while also addressing excessive heating at the point in the loop where the medical lead intersects itself. The strain relief loop includes a body section that the medical lead passes through where the intersection occurs. The body section may be a thermal non-conductor and isolate from excessive heating at the intersection point or may be a thermal conductor and distribute the excessive heating. The strain relief loop may include features such as arms or a coil extending from the body segment with arm segments at the ends of the arms defining lead passageways that assist in maintaining the strain relief loop. The body segment may have a single lead passageway where the intersection point occurs or may have multiple lead passageways. The body itself may house the loop by forming a loop or a capsule.

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Columbia Heights, MN, United States of America

Spencer M Bondhus