Greatbatch Ltd.

Pulse Technologies, Inc.

Pulse IP, LLC

Andrew E Fisk

Christine A Frysz

Warren S Dabney

Robert C O'Brien

Robert Naugler

Anatolii Demchyshyn

Mykola Kuzmenko

Leonid Kulak

Richard X Fu

Sergei Firstov

Anatolli Demchyshyn

A biocompatible, implantable electrode for electrically active medical devices. The implantable medical electrode has a surface geometry which optimizes the electrical performance of the electrode, while mitigating the undesirable effects associated with prior art porous surfaces. The electrode has an optimized surface topography for improved electrical performance. Such a electrode is suitable for devices which may be permanently implanted in the human body as stimulation electrodes, such as pacemakers, or as sensors of medical conditions. Such is achieved by the application of ultrafast high energy pulses to the surface of a solid, monolithic electrode material for the purpose of increasing the surface area and thereby decreasing its after-potential polarization.

Biocompatible implantable electrode

A titanium based, ceramic reinforced body formed from an alloy having from about 3 wt. % to about 10 wt. % of zirconium, about 10 wt. % to about 25 wt. % of niobium, from about 0.5 wt. % to about 2 wt. % of silicon, and from about 63 wt. % to about 86.5 wt. % of titanium. The alloy has a hexagonal crystal lattice &#x3b1; phase of from about 20 vol % to about 70 vol %, and a cubic body centered &#x3b2; crystal lattice phase of from about 30 vol. % to about 80 vol. %. The body has an ultimate tensile strength of about 950 MPa or more, and a Young's modulus of about 150 GPa or less. A molten substantially uniform admixture of a zirconium, niobium, silicon, and titanium alloy is formed, cast into a shape, and cooled into body. The body may then be formed into a desired shape, for example, a medical implant and optionally annealed.

Titanium based ceramic reinforced alloy

A biocompatible, implantable electrode for electrically active medical devices. The implantable medical electrode has a surface geometry which optimizes the electrical performance of the electrode, while mitigating the undesirable effects associated with prior art porous surfaces. The electrode has an optimized surface topography for improved electrical performance. Such a electrode is suitable for devices which may be permanently implanted in the human body as stimulation electrodes, such as pacemakers, or as sensors of medical conditions. Such is achieved by the application of ultrafast high energy pulses to the surface of a solid, monolithic electrode material for the purpose of increasing the surface area and thereby decreasing its after-potential polarization. In addition, the electrode material comprises a biocompatible metal having a minimal or eliminated amount of metal oxides which are detrimental to electrode performance.

Biomedical electrode having low oxygen content

Biomedical electrode

A titanium based, ceramic reinforced alloy ingot for use in producing medical implants. An ingot is formed from an alloy having comprising from about 5 to about 35 wt. % niobium, from about 0.5 to about 3.5 wt. % silicon, and from about 61.5 to about 94.5 wt. % of titanium. The alloy has a hexagonal crystal lattice &#x3b1; phase of from about 20 vol % to about 70 vol %, and a cubic body centered &#x3b2; crystal lattice phase of from about 30 vol. % to about 80 vol. %. The ingot has an ultimate tensile strength of about 940 MPa or more, and a Young's modulus of about 150 GPa or less. A molten substantially uniform admixture of a niobium, silicon, and titanium alloy is formed, cast into a shape, and cooled into an ingot. The ingot may then be formed into a medical implant and optionally annealed.

Titanium based ceramic reinforced alloy for use in medical implants

An implantable electrode comprising a substrate supporting microscopic surface structures such as columnar titanium nitride and further having nanoscopic surface structures on titanium nitride deposited on the exposed surface of the microscopic columnar structures is described. This is done through physical vapor deposition (PVD) and is based upon a relatively abrupt change in the surface mobility of the depositing material with a consequential variation in nucleation site density and surface mobility. At low mobility, there are increased nucleation sites and the condensation features are more numerous and finer. As mobility of the deposited species increases, the nucleation sites in the condensate film become fewer with coarser features. Consequently, the change from a relatively coarse microscopic surface structure to a relatively fine nanoscopic surface structure is accomplished by abruptly changing the total gas pressure in the processing chamber within a relatively short period of time of about ten seconds, or less.

Method for producing implantable electrode coatings with a plurality of morphologies

A feedthrough filter capacitor assembly is described. The feedthrough filter capacitor assembly comprises an outer ferrule hermetically sealed to an insulator of a dielectric material seated within the ferrule. The insulative material is also hermetically sealed to at least one lead wire. Instead of being made of platinum or platinum/iridium, the lead wire comprises a core of a non-noble metal supporting a functionally graded coating. The metal core has an inner layer of the same the non-noble metal of the core and an outer layer of a noble metal. A gradient transition zone exists between the non-noble metal and the outer noble metal. Consequently, lead wires having all the beneficial attributes of platinum and platinum/iridium wire can be built into hermetic feedthroughs, but at a significantly reduced cost. In a preferred form, a filter capacitor is mounted on the insulator and electrically connected to the lead wires and to the ferrule to prevent unwanted EMI signals from traveling along the wires and entering the interior of the medical device.

Functionally graded coatings for lead wires in medical implantable hermetic feedthrough assemblies

High reliability electrical connections between a helical strand and flat electrodes, such us strip electrodes found in implantable neurostimulator system, are described. The connection consists of a crimp joint in which an inside diameter mandrel is used to provided the coil with sufficient radial rigidity to ensure structural integrity of the crimp. The mandrel is made of a relatively soft biocompatible material that deforms rather than damages the fine wires of the helical strand during crimping. The crimping is accomplished by radial deformation of an annular or semi-annular crimping member that receives the helical strand/mandrel assembly.

Connection for a coiled lead to an electrical contact for an implantable medical device

High reliability electrical connections between a helical strand and flat electrodes, such as strip electrodes found in implantable neurostimulator system, are described. The connection consists of a crimp joint in which an inside diameter mandrel is used to provide the coil with sufficient radial rigidity to ensure structural integrity of the crimp. The mandrel is made of a relatively soft biocompatible material that deforms rather than damages the fine wires of the helical strand during crimping. The crimp is accomplished by radial deformation of an annular or semi-annular crimping member that receives the helical strand/mandrel assembly.

High reliability electrical connections between a helical strand and flat electrodes, such as strip electrodes found in implantable neurostimulator systems, are described. The connection consists of a crimp joint in which an inside diameter mandrel is used to provided the coil with sufficient radial rigidity to ensure structural integrity of the crimp. The mandrel is made of a relatively soft biocompatible material that deforms rather than damages the fine wires of the helical strand during crimping. The crimp is accomplished by radial deformation of an annular or semi-annular crimping member that receives the helical strand/mandrel assembly.

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Philadelphia, PA, United States of America

Andrew E Fisk