Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
1999-12-13
2002-03-19
Bockelman, Mark (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
C607S120000, C600S375000, C604S057000
Reexamination Certificate
active
06360129
ABSTRACT:
BACKGROUND OF THE ART
1. Field of the Invention
The present invention relates to the field of insertable or implantable materials or devices in which the material or device is secured into the tissue of a patient through a helical or screw element which is secured into tissue or the like. In particular, the present invention relates to protective elements such as protective caps over a penetrating or pointed section of the material or device, wherein the protective element is capable of timely removal (as by dissolution) from the penetrating or pointed section during technical (e.g., medical) procedures. Typical devices for use in the present invention are connectors or leads for electrical stimulation or pacing of organs, such as cardiac pacers or defibrillators.
2. Background of the Art
Many therapeutic or protective procedures for patients include the implantation of devices into a patient. Such implantations include drug delivery systems, electrostimulating devices (such as pacemakers or pain reduction devices), monitoring devices, electrical leads, electrodes, sensor elements, etc. These devices often have to be firmly secured within the patient to prevent movement of the device that would defeat or diminish its effectiveness. This is particularly true with electrical leads in pacing or defibrillation devices, which must be precisely located so that electrical stimulation is effective. There are a number of different formats for the securement of electrical leads in patients, including, but not limited to, clips, sutured attachment, corkscrew-like inserts (referred to as helical inserts), and other conventional securement formats found in mechanical systems.
A preferred means of securing leads is the helical insert such as found in the GUIDANT™ Sweet-Tip™ Model 4269 bipolar endocardial lead. This lead comprises a helical element having a base side (proximal end) with an electrode and a sharp tip on an insert side (a distal end) of the element. The pointed end penetrates tissue when a rotating motion is applied to the helical element, causing the element to puncture and or screw into the tissue, advancing the proximal end towards the tissue. The proximal end may have a relatively flat or convex electrical plate, electrode, sensing element (e.g., semiconductor, circuit board, pressure plate, etc.) or contact, and the advancing of the helical element into the tissue brings the contact into firm position with the tissue. In pacing or defibrillating devices, the electrical discharge passes through the electrode and/or into the helical connecting element. In some leads, the helical element is coated with an insulating polymer (which must also be biocompatible) to render the helical element inactive or passive (from the standpoint of discharge). Typical polymer coatings could include polyamides, polyurethanes, silicone resins, polyacrylates, hardened gelatin, and especially poly-para-xylylene (e.g., Parylene C).
U.S. Pat. No. 5,964,794 describes an implantable stimulation electrode for use with an implantable tissue stimulator, in particular a pacemaker, defibrillator, bone or neurostimulator, having a metal substrate body and a coating, applied to the substrate body, for reducing the electrode impedance and/or increasing the tissue comparability, in which an ultrathin, specifically functionalized organic coating forming the entire outer surface of the stimulation electrode is provided, which adheres to the underlying surface as a consequence of irreversible physisorption or covalent chemical bonding. An organic layer is provided on the surface of an implantable stimulation electrode, which layer prevents or at least decisively reduces the nonspecific adsorption of biological macromolecules and is selectively specifically functionalized or functionalizable. Such an effect, which leads to a novel quality of biocompatibility while simultaneously obtaining high phase-boundary capacitance and hence low electrode impedance, is unattainable with the known stimulation electrodes having a metallic or inorganic surface. The term “organic layer” will be used hereinafter to include such a layer having silicon atoms, of the kind that can be formed by reaction with silanes, for instance. An additional functionalization of potential practical significance is that the organic layer has sensor molecules (such as enzymes) such that the stimulation electrode can act as a biosensor electrode. In a further important functionalization, the organic layer has a medicinal active ingredient, in particular an anti-inflammatory medication, which can be exported from the organic layer under diffusion or solution control. In particular, the medicinal active ingredient may be substantially embedded between constituent layers of the multilayer structure. The organic layer is ultrathin; that is, its layer thickness of the organic coating is in the range between 1 and 200 nm, and in certain versions (for instance as a polyelectrolyte multilayer) is preferably in the range between 3 and 50 nm. To assure advantageous electrical properties, and especially little influence on the high phase-boundary capacitance of highly sophisticated stimulation electrodes, even at relatively high layer thicknesses in the aforementioned range, the organic layer in an advantageous embodiment is embodied such that it has a relative dielectric constant of greater than 100 and in particular greater than 300. At very slight layer thicknesses, layers with a relatively low dielectric constant can also be used.
U.S. Pat. No. 5,080,099 describes skin electrodes with hydrogel contact elements as stimulation electrodes for an external defibrillator and/or pacemaker.
A suitable conductive gel 106 would be, for example, an RG 63T hydrogel.
U.S. Pat. No. 5,951,597 describes a coronary sinus lead having an expandable matrix anchor. An intravenous lead for use with a cardiac device for implantation in the coronary venous system of the heart includes a lead body that is adapted to be routed through the vascular system into the coronary sinus with the distal end portion of the lead placed in the great cardiac vein or branch vein. The lead body includes a fixation member disposed just proximal of its tip. The fixation member comprises a radially expandable polymeric matrix that incorporates an osmotic agent so that when placed in a aqueous medium it will swell. Thus, when placed in a cardiac vein, the swelling of the fixation member will anchor the lead against longitudinal displacement due to body motion, blood flow and the beating action of the heart.
U.S. Pat. No. 4,347,198 describes the manufacture of contact lenses where a hydrophilic component, for example N-vinylpyrrolidone, a hydrophobic component, for example methyl methacrylate, a cross-linking agent and an initiator are mixed in a solvent, for example DMSO, and then the whole is cross-linked in a mold. After extraction and equilibration in water, a soft hydrogel contact lens is obtained. Extraction with water is necessary because the solvent and unreacted vinyl monomers have to be removed. Since a polymer swells to different extents, for example in DMSO on the one hand and water on the other, the contact lens assumes its final size only at that stage.
EP 216 074 describes a process for the preparation of hydrogel contact lenses. There, a methacrylate-modified polyvinyl alcohol is used which is copolymerised in DMSO solution with vinyl monomers in a suitable casting mold, for example in the presence of a photoinitiator by irradiation with UV light for approximately
3
hours. After being removed from the mold, the contact lens is extracted with water or physiological saline solution in order to remove the DMSO and unreacted vinyl monomers. In this case too, the contact lens does not receive its final geometry until the final stage owing to the different influences of DMSO and water on its swelling behavior.
U.S. Pat. No. 5,931,862 discloses a continuous sheath of open-celled porous plastic, preferably PTFE, is used on the outside of a medical lead, extending along the lead body and the el
Hum Larry L.
Ley Gregory R.
Bockelman Mark
Cardiac Pacemakers Inc.
Schwegman Lundberg Woessner & Kluth P.A.
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