Biostimulator having resilient scaffold
A biostimulator, such as a leadless cardiac pacemaker, including a fixation element and an electrode mounted on a resilient scaffold, is described. The fixation element and the resilient scaffold are coupled to a housing of the biostimulator. The resilient scaffold can support the electrode against a target tissue at a location that is radially offset from a location where the fixation element anchors the housing to the target tissue. A flexibility of the resilient scaffold allows the electrode to conform to a shape and movement of the target tissue when the housing is rigidly fixed to the target tissue by the fixation element. The resiliently supported electrode that is radially offset from the anchor point can reliably pace the target tissue without piercing the target tissue. Other embodiments are also described and claimed.
1 . A biostimulator, comprising:
a housing having a longitudinal axis and an electronics compartment containing a processor configured to stimulate a target tissue; and
a header assembly mounted on the housing, wherein the header assembly includes
a helical fixation element extending distally from the housing and including a piercing tip having a sharpened point to pierce target tissue, and
an elongated member extending distally from the housing, wherein the elongated member includes an electrode electrically connected to the processor to stimulate the target tissue, and a piercing element to anchor the electrode against the target tissue, wherein the piercing element includes a barb extending from the elongated member to engage the target tissue, and wherein the electrode is longitudinally distal to the piercing tip, both when the biostimulator is in an undeployed state with the helical fixation element unattached to the target tissue and when the biostimulator is in a deployed state with the helical fixation element attached to the target tissue.
2 . The biostimulator of claim 1 further comprising a hook extending from the elongated member to engage the target tissue.
3 . The biostimulator of claim 1 , wherein the elongated member is resiliently recoverable to the undeployed state from the deployed state.
4 . The biostimulator of claim 1 , wherein the elongated member extends distally to a tissue contact region, and wherein the electrode is mounted on the elongated member at the tissue contact region.
5 . A biostimulator system, comprising:
a catheter having an inner lumen; and
a biostimulator disposed in the inner lumen, wherein the biostimulator includes
a housing having a longitudinal axis and an electronics compartment containing a processor configured to stimulate a target tissue, and
a header assembly mounted on the housing, wherein the header assembly includes
a helical fixation element extending distally from the housing and including a piercing tip having a sharpened point to pierce target tissue, and
an elongated member extending distally from the housing, wherein the elongated member includes an electrode electrically connected to the processor to stimulate the target tissue, and a piercing element to anchor the electrode against the target tissue, wherein the piercing element includes a barb extending from the elongated member to engage the target tissue, and wherein the electrode is longitudinally distal to the piercing tip, both when the biostimulator is in an undeployed state with the helical fixation element unattached to the target tissue and when the biostimulator is in a deployed state with the helical fixation element attached to the target tissue.
6 . The biostimulator system of claim 5 , wherein the elongated member extends distally to a tissue contact region, and wherein the electrode is mounted on the elongated member at the tissue contact region.
7 . A method, comprising:
advancing a distal region of a catheter into a chamber of a heart, wherein the distal region has an inner lumen containing a biostimulator, wherein the biostimulator includes a housing having a longitudinal axis and an electronics compartment containing a processor configured to stimulate a target tissue of the heart, and a header assembly mounted on the housing, wherein the header assembly includes a helical fixation element extending distally from the housing and including a piercing tip having a sharpened point to pierce target tissue, and an elongated member extending distally from the housing, and wherein the elongated member includes an electrode electrically connected to the processor to stimulate the target tissue, and a piercing element to anchor the electrode against the target tissue, wherein the piercing element includes a barb extending from the elongated member to engage the target tissue, and wherein the electrode is longitudinally distal to the piercing tip, both when the biostimulator is in an undeployed state with the helical fixation element unattached to the target tissue and when the biostimulator is in a deployed state with the helical fixation element attached to the target tissue; and
deploying the biostimulator from the distal region, wherein when the biostimulator is deployed the biostimulator is in a deployed state such that the piercing element is engaged to the target tissue and the electrode is in contact with the target tissue.
8 . The method of claim 7 , wherein the elongated member extends distally to a tissue contact region, and wherein the electrode is mounted on the elongated member at the tissue contact region.