Lead positioning and finned fixation system
A therapy assembly configured for at least partial insertion in a living body. At least one fixation structure is attached to the therapy delivery element proximate the electrodes. The fixation structure is configured to collapse radially inward and wrap circumferentially around the therapy delivery element to a collapsed configuration when inserted into a lumen of an introducer. The fixation structures deploy to a deployed configuration when the introducer is retracted. The fixation structure includes major surfaces generally parallel with, and extending radially outward from, a central axis of the therapy delivery element, proximal edge surface oriented toward the proximal end, and a distal edge surface oriented toward the distal end. The proximal and distal edge surfaces provide generally symmetrical resistance to displacement of the therapy delivery element within the living body in either a proximal direction or a distal direction along the central axis.
1. An apparatus, comprising:
a therapy delivery element having a body that extends along a central axis, wherein the body includes a distal end and a proximal end opposite the distal end;
one or more electrodes located on the therapy delivery element;
a first fixation assembly that is coupled to the therapy delivery element, wherein the first fixation assembly includes a plurality of first fixation structures that, in a deployed configuration, each protrude radially outward from the body of the therapy delivery element; and
a second fixation assembly that is coupled to the therapy delivery element, wherein the second fixation assembly includes a plurality of second fixation structures that, in the deployed configuration, each protrude radially outward from the body of the therapy delivery element, and wherein the first fixation structures are rotationally offset with respect to the second fixation structures in the deployed configuration;
wherein:
at least one of the first fixation structures or at least one of the second fixation structures includes an edge surface that angles inward so as to create an undercut; and
for the at least one of the first fixation structures or the at least one of the second fixation structures that includes the edge surface that angles inward, an opposing edge surface extends perpendicularly to the central axis.
2. The apparatus of claim 1 , further comprising a sleeve, wherein the first fixation assembly and the second fixation assembly are attached to the sleeve, and wherein the sleeve is bonded to the therapy delivery element.
3. The apparatus of claim 1 , wherein the first fixation structures and the second fixation structures are each radially collapsible in a collapsed configuration.
4. The apparatus of claim 3 , wherein in the collapsed configuration:
the first fixation structures each wrap around the body of the therapy delivery element but do not overlap with one another; and
the second fixation structures each wrap around the body of the therapy delivery element but do not overlap with one another.
5. The apparatus of claim 4 , wherein the first fixation structures and the second fixation structures each resist displacement of the therapy delivery element in a distal direction or in a proximal direction along the central axis.
6. The apparatus of claim 1 , wherein at least one of the first fixation structures or at least one of the second fixation structures includes one or more holes therein.
7. The apparatus of claim 1 , wherein at least one of the first fixation structures or at least one of the second fixation structures has a free-floating end that is unattached to the therapy delivery element.
8. The apparatus of claim 1 , wherein the first fixation structures and the second fixation structures each have a rectangular shape.
9. The apparatus of claim 1 , wherein at least one of the first fixation structures or at least one of the second fixation structures includes tapered edges.
10. The apparatus of claim 9 , wherein at least one of the tapered edges includes a segment that extends in parallel with the central axis.
11. The apparatus of claim 1 , wherein no axial spacing exists between the first fixation assembly and the second fixation assembly.
12. An apparatus, comprising:
a therapy delivery element having a body that extends along a central axis, wherein the body includes a distal end and a proximal end opposite the distal end;
one or more electrodes located on the therapy delivery element; and
at least a first fixation assembly and a second fixation assembly each coupled to the therapy delivery element, wherein the first fixation assembly and the second fixation assembly are spaced apart in a longitudinal direction along the central axis, and wherein the first fixation assembly includes a plurality of first fixation structures, and wherein the second fixation assembly includes a plurality of second fixation structures;
at least one of the first fixation structures or at least one of the second fixation structures includes an edge surface that angles inward so as to create an undercut;
for the at least one of the first fixation structures or the at least one of the second fixation structures that includes the edge surface that angles inward, an opposing edge surface extends perpendicularly to the central axis;
wherein:
in a collapsed configuration, each of the first fixation structures and second fixation structures radially wraps around the body of the therapy delivery element;
in a deployed configuration, each of the first fixation structures and second fixation structures protrudes radially outward with respect to the central axis and perpendicularly with respect to a surface of the therapy delivery element in a side view; and
in the deployed configuration, each of the first fixation structures and second fixation structures points in a different radial direction.
13. The apparatus of claim 12 , wherein for each of the first and second fixation assemblies in the collapsed configuration: none of the first and second fixation structures overlap with one another.
14. The apparatus of claim 12 , wherein in the deployed configuration, the first and second fixation structures each resist displacement of the therapy delivery element in a distal direction or in a proximal direction along the central axis.
15. The apparatus of claim 12 , wherein at least one of first and second fixation structures includes a plurality of openings therein.
16. The apparatus of claim 12 , wherein no intermediate elements exist between the first and second fixation assemblies along the central axis.
17. The apparatus of claim 12 , further comprising a sleeve, wherein the first fixation assembly and the second fixation assembly are attached to the sleeve, and wherein the sleeve is bonded to the therapy delivery element.
18. An apparatus for delivering electrical stimulation to a patient, comprising:
a therapy delivery element having a body that extends along a central axis, wherein the body includes a distal end and a proximal end opposite the distal end;
one or more electrodes located on the therapy delivery element;
a first fixation assembly that is coupled to the therapy delivery element, wherein the first fixation assembly includes a plurality of first fixation structures that, in a deployed configuration, each protrude radially outward from the body of the therapy delivery element;
a second fixation assembly that is coupled to the therapy delivery element, wherein the second fixation assembly includes a plurality of second fixation structures that, in the deployed configuration, each protrude radially outward from the body of the therapy delivery element, and wherein the first fixation structures are rotationally offset with respect to the second fixation structures in the deployed configuration; and
a sleeve, wherein the first fixation assembly and the second fixation assembly are attached to the sleeve, and wherein the sleeve is bonded to the therapy delivery element;
wherein:
the first fixation structures and the second fixation structures are each radially collapsible in a collapsed configuration under which: the first fixation structures each wrap around the body of the therapy delivery element but do not overlap with one another, and the second fixation structures each wrap around the body of the therapy delivery element but do not overlap with one another, and wherein none of the first or second fixation structures circumferentially overlap when wrapped around the body of the therapy delivery element; and
the first fixation structures and the second fixation structures each resist displacement of the therapy delivery element in a distal direction or in a proximal direction along the central axis.
19. The apparatus of claim 18 , further comprising a third fixation assembly that is coupled to the therapy delivery element, wherein the third fixation assembly includes a plurality of third fixation structures that:
in the deployed configuration, each protrude radially outward from the body of the therapy delivery element; and
in the collapsed configuration, each wrap around the body of the therapy delivery element;
wherein in the deployed configuration, the third fixation structures are rotationally offset with respect to the second fixation structures but are rotationally aligned with respect to the first fixation structures.
20. The apparatus of claim 18 , wherein in the deployed configuration, at least some of the first fixation structures and the second fixation structures protrude perpendicularly with respect to a surface of the therapy delivery element in a side view.