WO2002081022B1 - System and method for detecting dislodgement of an implantable medical device - Google Patents

System and method for detecting dislodgement of an implantable medical device

Info

Publication number
WO2002081022B1
WO2002081022B1 PCT/US2002/009892 US0209892W WO02081022B1 WO 2002081022 B1 WO2002081022 B1 WO 2002081022B1 US 0209892 W US0209892 W US 0209892W WO 02081022 B1 WO02081022 B1 WO 02081022B1
Authority
WO
WIPO (PCT)
Prior art keywords
signal
imd
orientation
distal end
indicative
Prior art date
Application number
PCT/US2002/009892
Other languages
French (fr)
Other versions
WO2002081022A1 (en
Inventor
William J Flickinger
Jerome Edwards
Bradley Jascob
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 EP02763875A priority Critical patent/EP1377340B1/en
Priority to JP2002579060A priority patent/JP2004526516A/en
Priority to CA002443457A priority patent/CA2443457A1/en
Priority to DE60219905T priority patent/DE60219905T2/en
Publication of WO2002081022A1 publication Critical patent/WO2002081022A1/en
Publication of WO2002081022B1 publication Critical patent/WO2002081022B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
    • 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
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • 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
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • A61N1/36578—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
    • 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
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3702—Physiological parameters
    • 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
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3706—Pacemaker parameters

Abstract

An improved system and method for detecting dislodgement of an implantable medical device (IMD) such as a catheter or lead is disclosed. The system includes means for generating multiple, orthogonally-related signals within a body. For example, three current signals having a current path substantially oriented in the X, Y, and Z directions may be generated within the body. The invention further includes an IMD having an affixation device such as a helix at a distal tip for attachment to body tissue, and at least two sensing devices to sense the signals generated within the body. The difference in signal levels between two of the sensing devices may be measured. For example, a voltage potential difference created by the currents within the body may be measured between two electrodes. This measured signal level has components in the X, Y, and Z directions, and may therefore be used to define a directional vector in three-dimensional space. This vector is indicative of the orientation of the IMD. By comparing a directional vector indicative of a current IMD position with a vector indicative of a reference orientation, dislodgement of the IMD may be detected. In one embodiment, the reference orientation may be associated with a position wherein the IMD distal end is substantially perpendicular to the tissue. The comparison between the reference orientation and a subsequent IMD orientation may be performed by calculating the angle between the two associated vectors. If the angle exceeds a predetermined maximum angle, dislodgement is indicated.

Claims

23AMENDED CLAIMS[received by the International Bureau on 17 October 2002 (17.10.02); original claims 1-28 replaced by amended claims 1-28 (5 pages)]
1. A system for detecting dislodgement of a first implantable medical device (IMD) affixed to body tissue at an elongated distal end of the first IMD, the system characterised by: first and second sensing devices (47, 48) carried on the elongated distal end; a sensing circuit (52, 56, 59) to obtain first and second signal measurements via the first and second sensing devices, respectively, and to further obtain a difference between the first and second signal measurements, wherem the difference is indicative of an orientation of the D; and a processing circuit (65) to determine an allowable region of movement associated with the elongated distal end, and to further determine whether the orientation of the MD is indicative of dislodgement of the elongated distal end.
2. The system of claim 1, further characterized by a user interface (72) coupled to the processing circuit to receive user-specified data, and characterized in that the processing circuit is adapted to determine the allowable region of movement from the ser-specified data.
3. The system of Claim 2, characterized in that the user-specified data includes an allowable angle of motion.
4. The system of Claim 3, characterized in tftat the sensing circuit includes means for sensing a reference signal indicative of a reference orientation of the elongated distal end, and wherein the processing circuit determines the allowable region of movement as ϋompared to the reference orientation.
5. The system of Claim 4, characterized in that the user interface is adapted to receive a signal from a user indicating when the reference signal should be obtained.
6. The system of Claim 4, characterized in that the user interface is adapted to receive an indication of a maximum angle, and wherein the processing circuit includes means for defining the allowable region as that region wherein an angle between a longitudinal axis of the IMD and the reference orientation has a predetermined relationship to the maximum angle.
7. The system of Claim 6, characterized in that the processing circuit includes means for defining the allowable region as that region wherein an angle between a longitudinal axis of the IMD and the reference orientation is less than the maximum angle.
8. The system of Claim 1, further characterized by signal means for generating three substantially orthogonal signals in the tissue.
9. The system of Claim 8, characterized in that the signal means includes means for generating three substantially orthogonal alternating current signals in the tissue.
10. The system of claim 9, characterized in that the first and second sensing devices are electrodes.
11. The system of claim 10, characterized in that the sensing circuit includes a circuit to measure a voltage potential difference that exists between the first and second sensing devices.
12. The system of Claim 2, characterized in that the user interface includes a display to provide a three-dimensional representation of the location of the distal end of the IMD.
13. The system of Claim 1 , characterized in that the processing circuit includes qalibration means for determining calibration factors associated with the first and second signal measurements. 25
14. The system of Claim 13, characterized in that the calibration means generates sensitivity values associated with a three-dimensional vector.
15. The system of Claim 1, further characterized by a second IMD carrying a third sensing device to detect a third signal measurement, and characterized in mat the processing circuit includes means to utilize ones of the first, second, and third signal measurements to obtain directional data indicative of the position of the second IMD.
16. A method for detecting dislodgement of an MD within a body, the MD having a distal end carrying first and second signal sensing devices and wherein the distal end is adapted to be affixed to body tissue, the method characterized by: a.) determining a reference orientation of the MD when the distal end is affixed to body tissue; b ) obtaining a first measurement of one or more signal levels existing at the first signal sensing device; c.) obtaining a second measurement of one or more signal levels existing at the second signal sensing device; d.) calculating a difference between the first and second measurements; e.) utilizing the calculated difference to determine a directional vector indicative of a second orientation of the distal end of the MD; and f.) comparing the reference orientation and the second orientation to determine likelihood of lead dislodgement.
17. The method of claim 16, characterized in that the one or more signal levels include a voltage potential, and wherein step d.) includes obtaining a voltage potential difference between the first and second signal sensing devices.
18. The method of claim 16, characterized in chat the one or more signal levels include one or more magnetic fields, and wherein step d.) includes calculating a 26
difference between the magnetic field strength at the first signal sensing device and the magnetic field strength at the second signal sensing device.
19. The method of Claim 16, characterized in that step a,) includes allowing a user to select the reference orientation.
20. The method of Claim 16, characterized in that step a.) includes selecting the reference orientation as the orientation wherein the distal end is substantially perpendicular to the body tissue at the point the MD is affixed to the body tissue.
21. The method of Claim 17, characterized in that step b.) includes the methods of*, obtaining the first measurement of a voltage potential difference between a reference voltage point and the first signal sensing device; obtaining the second measurement of a voltage potential difference between a reference voltage point and the second signal sensing device; and calculating the difference between the first measurement and the second measurements to obtain the voltage potential difference existing between the first and second signal sensing devices.
22. The method of claim 16, characterized in that step b.) includes obtaining components indicative of a point in three-dimensional space for each of the first and second measurements.
23. The method of claim 16, characterized in that step e.) includes calculating sensitivity values for the one or more signal levels:
24. The method of claim 16, characterized in that step b.) includes generating three substantially orthogonal signals in the body tissue. 27
25. The method of claim 24, characterized in that step b.) includes generating three substantially orthogonal alternating current signals in the body tissue.
26. The method of claim 16, further characterized by generating a visual image of the second orientation of the distal end of the MD.
27. The method of claim 16, further characterized by generating an audio signal indicative of the detected lead dislodgement.
28. The method of claim 16, further characterized by: providing a second MD in the body, the second MD having a third sensing device; obtaining a third measurement of one or more signal levels existing at the third signal sensing device; and utilizing ones of the first, second, and third measurements to determine the location of the third sensing device within the body.
PCT/US2002/009892 2001-04-03 2002-03-29 System and method for detecting dislodgement of an implantable medical device WO2002081022A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP02763875A EP1377340B1 (en) 2001-04-03 2002-03-29 System and method for detecting dislodgement of an implantable medical device
JP2002579060A JP2004526516A (en) 2001-04-03 2002-03-29 System and method for detecting implantable medical device misalignment
CA002443457A CA2443457A1 (en) 2001-04-03 2002-03-29 System and method for detecting dislodgement of an implantable medical device
DE60219905T DE60219905T2 (en) 2001-04-03 2002-03-29 SYSTEM AND METHOD FOR DETERMINING THE DISSOLUTION OF AN IMPLANTABLE MEDICAL DEVICE

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/824,953 2001-04-03
US09/824,953 US6807439B2 (en) 2001-04-03 2001-04-03 System and method for detecting dislodgement of an implantable medical device

Publications (2)

Publication Number Publication Date
WO2002081022A1 WO2002081022A1 (en) 2002-10-17
WO2002081022B1 true WO2002081022B1 (en) 2003-03-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/009892 WO2002081022A1 (en) 2001-04-03 2002-03-29 System and method for detecting dislodgement of an implantable medical device

Country Status (6)

Country Link
US (2) US6807439B2 (en)
EP (1) EP1377340B1 (en)
JP (1) JP2004526516A (en)
CA (1) CA2443457A1 (en)
DE (1) DE60219905T2 (en)
WO (1) WO2002081022A1 (en)

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Also Published As

Publication number Publication date
WO2002081022A1 (en) 2002-10-17
DE60219905T2 (en) 2008-01-17
CA2443457A1 (en) 2002-10-17
US20050004611A1 (en) 2005-01-06
EP1377340A1 (en) 2004-01-07
DE60219905D1 (en) 2007-06-14
JP2004526516A (en) 2004-09-02
EP1377340B1 (en) 2007-05-02
US6807439B2 (en) 2004-10-19
US20020161295A1 (en) 2002-10-31

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