MRI Compatible Leadless Cardiac Pacemaker
First Claim
1. A leadless biostimulator, comprising:
- a housing adapted to be implanted in or on a human heart, the housing having a total volume less than 1.5 cm3;
a first electrode and a second electrode coupled to the housing;
a pulse generator disposed in the housing and electrically coupled to the first and second electrodes, the pulse generator configured to generate and deliver electrical pulses to heart tissue via the first and second electrodes; and
a battery disposed in the housing and coupled to the pulse generator, the battery configured to supply energy for electrical pulse generation.
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Accused Products
Abstract
An implantable battery powered leadless pacemaker or biostimulator is provided that may include any of a number of features. One feature of the biostimulator is that it safely operates under a wide range of MRI conditions. One feature of the biostimulator is that it has a total volume small enough to avoid excessive image artifacts during a MRI procedure. Another feature of the biostimulator is that it has reduced path lengths between electrodes to minimize tissue heating at the site of the biostimulator. Yet another feature of the biostimulator is that a current loop area within the biostimulator is small enough to reduce an induced current and voltage in the biostimulator during MRI procedures. Methods associated with use of the biostimulator are also covered.
321 Citations
44 Claims
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1. A leadless biostimulator, comprising:
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a housing adapted to be implanted in or on a human heart, the housing having a total volume less than 1.5 cm3; a first electrode and a second electrode coupled to the housing; a pulse generator disposed in the housing and electrically coupled to the first and second electrodes, the pulse generator configured to generate and deliver electrical pulses to heart tissue via the first and second electrodes; and a battery disposed in the housing and coupled to the pulse generator, the battery configured to supply energy for electrical pulse generation. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A leadless biostimulator, comprising:
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a housing adapted to be implanted in or on a human heart; a first electrode and a second electrode coupled to the housing; a pulse generator disposed in the housing and electrically coupled to the first and second electrodes, the pulse generator configured to generate and deliver electrical pulses to heart tissue via the first and second electrodes; and a battery disposed in the housing and coupled to the pulse generator, the battery configured to supply energy for electrical pulse generation; wherein a loop area defined by a lead path from the first electrode to the second electrode and returning to the first electrode through the pulse generator is less than 1 cm2. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A method of operating a battery powered leadless biostimulator in or on the heart of the patient, comprising:
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performing an MRI procedure on the patient; and inducing a voltage in the leadless biostimulator less than 1.5 mV in response to the MRI procedure. - View Dependent Claims (31, 32, 33, 34, 35, 36)
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37. A method of obtaining an MRI image of a patient, the patient having an implanted battery powered leadless biostimulator, the method comprising:
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generating a static magnetic field, a pulsed gradient field, and an RF field in the patient; maintaining safe operation of the leadless biostimulator within the patient in the presence of the static magnetic field, the gradient field, and the RF field without attenuating or eliminating a signal in the leadless biostimulator.
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38. A leadless biostimulator, comprising:
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a housing adapted to be implanted in or on a human heart; a first electrode and a second electrode coupled to the housing; a pulse generator disposed in the housing and electrically coupled to the first and second electrodes, the pulse generator configured to generate and deliver electrical pulses to heart tissue via the first and second electrodes; and a battery disposed in the housing and coupled to the pulse generator, the battery configured to supply energy for electrical pulse generation; wherein the leadless biostimulator is configured for safe operation in or on the human heart during an MRI procedure without including an attenuation device to reduce or eliminate a signal in the leadless biostimulator during the MRI procedure. - View Dependent Claims (39, 40, 41, 42, 43)
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44. A method of performing an electrophysiological procedure on a heart, comprising
operating a leadless biostimulator implanted in the heart; - and
generating an induced voltage in the biostimulator of less than 1.5 mV during an MRI procedure without use of an attenuation device.
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Specification