Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems
Reexamination Certificate
2002-04-18
2004-12-28
Manuel, George (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical therapeutic systems
Reexamination Certificate
active
06836683
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to implantable medical devices (IMDs) and their various components, including flat electrolytic capacitors for same, and methods of making same, particularly such capacitors fabricated of a plurality of stacked capacitor layers each having anode layers fabricated of a plurality of anodized valve metal anode sheets.
BACKGROUND OF THE INVENTION
A wide variety of IMDs are known in the art. Of particular interest are implantable cardioverter-defibrillators (ICDs) that deliver relatively high-energy cardioversion and/or defibrillation shocks to a patient's heart when a malignant tachyarrhythmia, e.g., atrial or ventricular fibrillation, is detected. The shocks are developed by discharge of one or more high voltage electrolytic capacitor that is charged up from an ICD battery. Current ICDs typically possess single or dual chamber pacing capabilities for treating specified chronic or episodic atrial and/or ventricular bradycardia and tachycardia and were referred to previously as pacemaker/cardioverter/defibrillators (PCDs). Earlier developed automatic implantable defibrillators (AIDs) did not have cardioversion or pacing capabilities. For purposes of the present invention ICDs are understood to encompass all such IMDs having at least high voltage cardioversion and/or defibrillation capabilities.
Energy, volume, thickness and mass are critical features in the design of ICD implantable pulse generators (IPGs) that are coupled to the ICD leads. The battery(s) and high voltage capacitor(s) used to provide and accumulate the energy required for the cardioversion/defibrillation shocks have historically been relatively bulky and expensive. Presently, ICD IPGs typically have a volume of about 40 to about 60 cc, a thickness of about 13 mm to about 16 mm and a mass of approximately 100 grams.
It is desirable to reduce the volume, thickness and mass of such capacitors and ICD IPGs without reducing deliverable energy. Doing so is beneficial to patient comfort and minimizes complications due to erosion of tissue around the ICD IPG. The high voltage capacitor(s) are among the largest components that must be enclosed within the ICD IPG housing. Reductions in size of the capacitors may also allow for the balanced addition of volume to the battery, thereby increasing longevity of the ICD IPG, or balanced addition of new components, thereby adding functionality to the ICD IPG. It is also desirable to provide such ICD IPGs at low cost while retaining the highest level of performance. At the same time, reliability of the capacitors cannot be compromised.
Various types of flat and spiral-wound capacitors are known in the art, some examples of which are described as follows and/or may be found in the patents listed in Table 1 of commonly assigned U.S. Pat. No. 6,006,133. Typically, an electrolytic capacitor is fabricated with a capacitor case enclosing a “valve metal” (e.g., aluminum) anode layer (or “electrode”), a valve metal (e.g. aluminum) cathode layer (or “electrode”), and a Kraft paper or fabric gauze spacer or separator impregnated with a solvent based liquid electrolyte interposed therebetween. The aluminum anode layer is typically fabricated from aluminium foil that is first etched and then “formed” by passage of electrical current through the anode layer to oxidize the etched surfaces so that the aluminium oxide functions as a dielectric layer. The electrolyte comprises an ion producing salt that is dissolved in a solvent and provides ionic electrical conductivity between the cathode layer and the aluminum oxide dielectric layer. The energy of the capacitor is stored In the electromagnetic field generated by opposing electrical charges separated by the aluminum oxide layer disposed on the surface of the anode layer and is proportional to the surface area of the etched aluminum anode layer. Thus, to minimize the overall volume of the capacitor one must maximize anode surface area per unit volume without increasing the capacitor's overall (i.e., external) dimensions. The separator material, anode and cathode layer terminals, internal packaging, electrical interconnections, and alignment features and cathode material further increase the thickness and volume of a capacitor. Consequently, these and other components in a capacitor and the desired capacitance limit the extent to which its physical dimensions may be reduced.
Some ICD IPGs employ commercial photoflash capacitors similar to those described by Troup in “Implantable Cardioverters and Defibrillators,”
Current Problems in Cardiology
, Volume XIV, Number 12, Dec. 1989, Year Book Medical Publishers, Chicago, and as described in U.S. Pat. No. 4,254,775. The electrodes or anode and cathodes are wound into anode and cathode layers separated by separator layers of the spiral. Most commercial photoflash capacitors contain a core of separator paper intended to prevent brittle, highly etched aluminum anode foils from fracturing during winding of the anode, cathode, and separator layers into a coiled configuration. The cylindrical shape and paper core of commercial photoflash capacitors limits the volumetric packaging efficiency and thickness of an ICD IPG housing made using same.
More recently developed ICD IPGs employ one or more flat or “prismatic”, high voltage, electrolytic capacitor to overcome some of the packaging and volume disadvantages associated with cylindrical photoflash capacitors. Flat aluminum electrolytic capacitors for use in ICD IPGs have been disclosed, e.g., those Improvements described in “High Energy Density Capacitors for Implantable Defibrillators” presented by P. Lunsmann and D. MacFarlane at
CARTS
96: 16
th Capacitor and Resistor Technology Symposium
, 11-15 Mar. 1996, and at
CARTS
-
EUROPE
96: 10
th European Passive Components Symposium
., 7-11 Oct. 1996, pp. 35-39. Further features of flat electrolytic capacitors for use in ICD IPGs are disclosed in U.S. Pat. Nos. 4,942,501; 5,086,374; 5,131,388; 5,146,391; 5,153,820; 5,522,851, 5,562,801; 5,628,801; and 5,748,439, all issued to MacFarlane et al.
For example, U.S. Pat. Nos. 5,131,388 and 5,522,851 disclose a flat capacitor having a plurality of stacked capacitor layers each comprising an “electrode stack subassembly”. Each capacitor layer contains one or more anode sheet forming an anode layer having an anode tab, a cathode sheet or layer having a cathode tab and a separator for separating the anode layer from the cathode layer.
Electrical performance of such electrolytic capacitors is affected by the surface area of the anode and cathode layers and also by the resistance associated with the electrolytic capacitor itself, called the equivalent series resistance (ESR). The ESR is a “hypothetical” series resistance that represents all energy losses of an electrolytic capacitor regardless of source. The ESR results in a longer charge time (or larger build factor) and lower discharge efficiency. Therefore, it is desirable to reduce the ESR to a minimum.
Typically, ESR is minimized by fabricating the anode layer of each capacitor layer from highly etched valve metal foil, e.g., aluminum foil, that has a microscopically contoured, etched surface with a high concentration of pores extending part way through the anode foil along with tunnels extending all the way through the anode foil (through-etched or tunnel-etched) or only with a high concentration of pores extending part way through the anode foil (nonthrough-etched). In either case, such a through-etched or nonthrough-etched anode sheet cut from such highly etched foil exhibit a total surface area much greater than its nominal (length times width) surface area. A surface area coefficient, the ratio of the microscopic true surface area to the macroscopic nominal area, may be as high as 100:1, which advantageously increases capacitance. Through-etched or tunnel-etched anode sheets exhibit a somewhat lower ratio due to the absence of a web or barrier surface closing the tunnel as in nonthrough-etched anode sheets.
After the aluminum foil is etched, the aluminum ox
Bomstad Timothy T.
Nielsen Christian S.
Chapik Daniel G.
Manuel George
Medtronic Inc.
Wolde-Michael Girma
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