Leadless Cardiac Pacemaker with Secondary Fixation Capability
First Claim
1. A leadless biostimulator comprising:
- a power source adapted to be disposed within a human heart chamber;
an electrode in electrical communication with the power source and adapted to be placed in contact with tissue within the heart chamber;
a controller adapted to be disposed within the heart chamber and to control delivery of electrical energy from the power source to the electrode;
a primary fixation element adapted to affix the biostimulator to a primary fixation site on a heart wall within the heart chamber; and
a downstream vascular escape prevention assembly adapted to prevent an escape of the biostimulator in the event of it being dislodged from the primary fixation site.
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Accused Products
Abstract
The invention relates to leadless cardiac pacemakers (LBS), and elements and methods by which they affix to the heart. The invention relates particularly to a secondary fixation of leadless pacemakers which also include a primary fixation. Secondary fixation elements for LBS'"'"'s may either actively engage an attachment site, or more passively engage structures within a heart chamber. Active secondary fixation elements include a tether extending from the LBS to an anchor at another site. Such sites may be either intracardial or extracardial, as on a vein through which the LBS was conveyed to the heart, the internal or external surface thereof. Passive secondary fixation elements entangle within intraventricular structure such as trabeculae carneae, thereby contributing to fixation of the LBS at the implant site.
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Citations
49 Claims
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1. A leadless biostimulator comprising:
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a power source adapted to be disposed within a human heart chamber; an electrode in electrical communication with the power source and adapted to be placed in contact with tissue within the heart chamber; a controller adapted to be disposed within the heart chamber and to control delivery of electrical energy from the power source to the electrode; a primary fixation element adapted to affix the biostimulator to a primary fixation site on a heart wall within the heart chamber; and a downstream vascular escape prevention assembly adapted to prevent an escape of the biostimulator in the event of it being dislodged from the primary fixation site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A method for retaining a leadless intracardiac biostimulator in a heart in the event of dislodgement from a primary fixation site comprising:
entangling an element of the biostimulator within the heart structure at a secondary fixation site within a heart chamber, such entanglement being sufficient to retain the biostimulator within the cardiac chamber. - View Dependent Claims (34, 35, 36, 37, 38)
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39. A method for retaining a leadless intracardiac biostimulator in a heart in the event of dislodgement from a primary fixation site comprising:
anchoring the biostimulator with a tether to a secondary fixation site, the tether being of appropriate length to prevent substantial movement of the biostimulator into a downstream vascular from the primary fixation site of the biostimulator in a heart chamber. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
Specification