WO2002034333B1 - Surround shroud connector and electrode housings for a subcutaneous electrode array and leadless ecgs - Google Patents

Surround shroud connector and electrode housings for a subcutaneous electrode array and leadless ecgs

Info

Publication number
WO2002034333B1
WO2002034333B1 PCT/US2001/031466 US0131466W WO0234333B1 WO 2002034333 B1 WO2002034333 B1 WO 2002034333B1 US 0131466 W US0131466 W US 0131466W WO 0234333 B1 WO0234333 B1 WO 0234333B1
Authority
WO
WIPO (PCT)
Prior art keywords
electrodes
electrode
array
spaced apart
surround shroud
Prior art date
Application number
PCT/US2001/031466
Other languages
French (fr)
Other versions
WO2002034333A2 (en
WO2002034333A3 (en
Inventor
Thomas I Ceballos
John E Nicholson
Eric J Panken
James D Reinke
James Strom
Kevin K Tindemand
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Priority to CA002426951A priority Critical patent/CA2426951A1/en
Priority to EP01979587A priority patent/EP1331970B1/en
Priority to DE60130010T priority patent/DE60130010T2/en
Publication of WO2002034333A2 publication Critical patent/WO2002034333A2/en
Publication of WO2002034333A3 publication Critical patent/WO2002034333A3/en
Publication of WO2002034333B1 publication Critical patent/WO2002034333B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37512—Pacemakers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7207—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7217—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise originating from a therapeutic or surgical apparatus, e.g. from a pacemaker

Abstract

The invention discloses a subcutaneous electrode array or SEA for use in medical devices. The arrangement provides an enhanced capability for detecting and gathering electrical cardiac signals via the array of relatively closely spaced subcutaneous electrodes. Further, switching circuits, signal processors and memory to process electric cardiac signals are implemented to enable a leadless orientation-insensitive SEA scheme for receiving the electrical signal from the heart. The SEA is distributed over the perimeter of the implanted medical device and includes a non-conductive surround shroud of biocompatible material. The surround shroud is placed around the periphery of the case of the implanted medical device. Various configurations of recesses, each of which contain individual electrodes, are implemented to provide an enhanced signal to noise ratio for improved signal quality.

Claims

20AMENDED CLAIMS [received by the International Bureau on 25 May 2002 (25.05.02); original claims 1-11 replaced by amended claims 1-20 (2 pages)]WHAT IS T AIMED IS:
1. An apparatus for leadless acquisition of electrocardiographic data, characterized in that: a hermetically sealed case (201,301,302,401); a surround shroud member (48) having at lease two electrode-receiving receptacles (49a) formed therein; at least two spaced apart electrodes (61) disposed in said at least two electrode-receiving receptacles (49a); and an operable signal processing circuit (20) disposed inside the case (201,301,302,401) and electrically coupled to the at least two spaced apart electrodes (61).
2. An apparatus according to claim 1 wherein the surround shroud member has a channel formed therein and said channel couples to the electrode-receiving receptacles.
3. An apparatus according to claim 1 wherein the at least two spaced apart electrodes are substantially flat electrodes.
4. An apparatus according to claim 1 further including an electrically insulating member connecting the electrically-receiving receptacles to a terminal end portion of a branch of said channel.
5. An apparatus according to claim 4, further including an electrically conducting electrode contact member disposed in a part of the electrode-receiving receptacles.
6. An apparatus according to claim 5 wherein the at least two spaced apart electrodes are four electrodes.
7. An apparatus for leadless acquisition of electrocardiographic data, characterized in that: a hermetically sealed implantable device case (201,301,302,401); a surround shroud member (48) configured to mechanically couple to at least a portion of the peripheral edge of the case (201,301,302,401); an array of cardiac depolarization sensing electrodes (61) mechanically coupled to a like number of recesses (49a) formed in the surround shroud member (48), wherein the electrodes (61) are spaced apart from each other and electrically coupled in one or more pairs to the terminals of one or more sense amplifiers (24); and means for storing signals (30,32,40) from a selected pair of the electrodes (61) to determine a sensing vector that provides the largest cardiac signal.
8. An apparatus according to claim 7 wherein each of said array of cardiac depolarization sensing electrodes are spaced apart from an adjacent other of said electrodes either: (a) a maximum equivalent distance or (b) an orthogonal distance wherein said orthogonal distance equals the spacing required to produce a separation angle equaled to 90° with reference to the adjacent other of said electrodes.
9. An apparatus according to claim 7 wherein said electrode spacing includes a spacing of two vectors with a separation angle equaled to 90° to thereby form orthogonal spacing between electrode pairs.
10. An apparatus according to claim 7 wherein said array of cardiac depolarization sensing electrodes are three electrodes and the said portion of the casing is a length sufficient to form an equilateral triangle array with the three electrodes.
11. An apparatus according to claim 7 wherein the surround shroud further includes an elongated channel that branches to connect each location where an electrode of the array of cardiac depolarization sensing electrodes is coupled to the surround shroud.
12. An apparatus according to any of claims 7 - 11 wherein the casing housing substantially all the electronics of a one of the following: an implantable pacemaker, an implantable cardioverter defibrillator, an implantable drug pump, an implantable pulse generator or any implantable medical device disposed in a human body within range of receiving cardiac signals. 22
13. An apparatus according to claim 1 wherein said at least two spaced apart electrodes are at least a one of. a metallic coil electrode, a platinum wire, a coil of platinum wire, an electrically insulated metallic coil member, a platinum alloy wire, a coil of platinum alloy wire, a multi-layer ceramic electrode.
14. An apparatus according to claim 1 wherein at least a portion of the periphery surface of the case is substantially flat.
15. An apparatus or apparatus according to claim 1, 7 or 13 wherein the casing is formed of one of the following materials: a titanium material, a titanium alloy, a biocompatible metallic material, or a biocompatible material.
16. An apparatus or apparatus according to claim 15 wherein said shroud is formed of a biocompatible material, a polyurethane material, an extruded material, a thermoplastic material.
17. An apparatus according to claim 3, wherein said electrode-receiving receptacles are substantially round and have an annular surrounding wall portion.
18, An apparatus according to claim 1 further including a dedicated read/write memory storage structure disposed in the casing for registering historical cardiac signal values.
19. An apparatus according to claim 18 further including a telemetry circuit for communicating with a remote computerized interrogation apparatus.
20. An apparatus according to claim 19 wherein said remote computerized interrogation apparatus includes at least one of the following: a computer monitor; a tape printer, a keyboard, a removable data storage structure, a communication modem.
PCT/US2001/031466 2000-10-26 2001-10-05 Surround shroud connector and electrode housings for a subcutaneous electrode array and leadless ecgs WO2002034333A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
CA002426951A CA2426951A1 (en) 2000-10-26 2001-10-05 Surround shroud connector and electrode housings for a subcutaneous electrode array and leadless ecgs
EP01979587A EP1331970B1 (en) 2000-10-26 2001-10-05 Surround shroud connector and electrode housings for a subcutaneous electrode array and leadless ecgs
DE60130010T DE60130010T2 (en) 2000-10-26 2001-10-05 COVER CONNECTORS AND ELECTRODE BODIES FOR SUBCUTANEOUS ELECTRODE ARC AND WIRELESS ECG

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/697,438 US6522915B1 (en) 2000-10-26 2000-10-26 Surround shroud connector and electrode housings for a subcutaneous electrode array and leadless ECGS
US09/697,438 2000-10-26

Publications (3)

Publication Number Publication Date
WO2002034333A2 WO2002034333A2 (en) 2002-05-02
WO2002034333A3 WO2002034333A3 (en) 2002-06-20
WO2002034333B1 true WO2002034333B1 (en) 2002-09-12

Family

ID=24801115

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/031466 WO2002034333A2 (en) 2000-10-26 2001-10-05 Surround shroud connector and electrode housings for a subcutaneous electrode array and leadless ecgs

Country Status (5)

Country Link
US (1) US6522915B1 (en)
EP (1) EP1331970B1 (en)
CA (1) CA2426951A1 (en)
DE (1) DE60130010T2 (en)
WO (1) WO2002034333A2 (en)

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