Lead positioning and finned fixation system
View Patent ↗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. A therapy assembly configured for at least partial insertion in a living body, comprising:
a therapy delivery element comprising a proximal end having a plurality of electrical contacts configured to electrically couple with an implantable pulse generator and a distal end having a plurality of electrodes electrically coupled to the electrical contacts;
an introducer comprising a lumen configured to receive the therapy delivery element therein; and
a plurality of fixation structures attached to the therapy delivery element proximate from the electrodes, the plurality of fixation structures being configured to collapse radially inward and wrap circumferentially around the therapy delivery element into a collapsed configuration in a non-overlapping configuration when inserted into the lumen, and further being configured to deploy in a deployed configuration when the introducer is retracted from therearound, the plurality of fixation structures comprising major surfaces generally parallel with, and extending generally radially outwardly from, a central axis of the therapy delivery element, a proximal edge surface of the fixation structures being oriented towards the proximal end, a distal edge surface of the fixation structures being oriented towards the distal end;
wherein the proximal and distal edge surfaces are configured to provide generally symmetrical resistance to displacement of the therapy delivery element in either a proximal direction or a distal direction along the central axis when the therapy delivery element is implanted within the living body.
2. The therapy assembly of claim 1 , comprising a plurality of fixation assemblies arranged axially along the therapy delivery element, wherein each fixation assembly comprises at least one of the plurality of fixation structures.
3. The therapy assembly of claim 2 , wherein each fixation assembly comprises a plurality of the fixation structure structures, at least two of the fixation assemblies rotationally offset so the proximal and distal edge surfaces of the fixation structures on at least two fixation assemblies are out-of-plane.
4. The therapy assembly of claim 2 , wherein the fixation assemblies comprise an axial spacing is in a range between about zero inches to about 0.150 inches.
5. The therapy assembly of claim 1 , wherein the fixation structures comprise a radial dimension in a range between about 0.045 inches to about 0.065 inches, and an axial dimension in a range of about 0.050 inches to about 0.200 inches.
6. The therapy assembly of claim 1 , wherein the fixation structures comprise a pullout-force from the living body in a range of between about 0.50 pounds to about 3.00 pounds.
7. The therapy assembly of claim 1 , wherein at least one of the plurality of fixation structures is bonded directly to the therapy delivery element.
8. The therapy assembly of claim 1 , wherein at least one of the plurality of fixation structures is integrally formed into a sleeve that is bonded to the therapy delivery element.
9. The therapy assembly of claim 1 , wherein the plurality of fixation structures comprises at least four proximal edge surfaces and four distal edge surfaces.
10. The therapy assembly of claim 1 , wherein the proximal edge surfaces comprise a total surface area within about +/−20% or less than a total surface area of the distal edge surfaces.
11. The therapy assembly of claim 1 , wherein the plurality of fixation structures comprises a resistance to a displacement force applied to the therapy delivery element in the proximal direction is within about +/−20% or less to resistance to a displacement force applied in the distal direction.
12. A neurostimulation system comprising:
an implantable pulse generator;
a therapy delivery element comprising a proximal end having a plurality of electrical contacts configured to electrically couple with the implantable pulse generator and a distal end having a plurality of electrodes electrically coupled to the electrical contacts;
an introducer comprising a lumen configured to receive the therapy delivery element therein; and
a plurality of fixation structures attached to the therapy delivery element proximate from the electrodes, the fixation structures being configured to collapse radially inward and wrap circumferentially around the therapy delivery element into a collapsed configuration in a non-overlapping configuration when inserted into the lumen, and further being configured to deploy in a deployed configuration when the introducer is retracted from therearound, the plurality of fixation structures comprising major surfaces generally parallel with, and extending generally radially outwardly from, a central axis of the therapy delivery element, a proximal edge surface of the fixation structures being oriented towards the proximal end, a distal edge surface of the fixation structures being oriented towards the distal end;
wherein the proximal and distal edge surfaces are configured to provide generally symmetrical resistance to displacement of the therapy delivery element in either a proximal direction or a distal direction along the central axis when the therapy delivery element is implanted within the living body.
13. The neurostimulation system of claim 12 , comprising a plurality of fixation assemblies arranged axially along the therapy delivery element, wherein each fixation assembly comprises at least one of the plurality of fixation structures.
14. The neurostimulation system of claim 13 , wherein each fixation assembly comprises a plurality of the fixation structures, at least two of the fixation assemblies rotationally offset so the proximal and distal edge surfaces of the fixation structures on at least two fixation assemblies are out-of-plane.
15. The neurostimulation system of claim 12 , wherein at least one of the plurality of fixation structures is bonded directly to the therapy delivery element.
16. The neurostimulation system of claim 12 , wherein at least one of the plurality of fixation structures is integrally formed into a sleeve that is bonded to the therapy delivery element.
17. A therapy assembly for at least partial insertion in a living body, the therapy comprising:
a therapy delivery element including:
a proximal end including at least one electrical contact configured to electrically couple with an implantable pulse generator; and
a distal end including at least one electrode electrically coupled to the at least one electrical contact;
an introducer including a lumen configured to receive the therapy delivery element therein; and
at least two or more fixation structures attached to the therapy delivery element proximate the distal end, the at least two or more fixation structures including a proximal edge surface oriented toward the proximal end and a distal edge surface oriented toward the distal end, wherein the at least two or more fixation structures include:
a collapsed configuration in which the at least two or more fixation structures wrap circumferentially around the therapy delivery element but not overlapping one another with insertion of the therapy delivery element into the lumen; and
a deployed configuration in which the at least two or more fixation structures expands radially outwardly from the therapy delivery element with the introducer retracted from the at least one fixation structure, wherein, in the deployed configuration, the proximal and distal edge surfaces are configured to provide substantially symmetrical resistance to displacement of the therapy delivery element in either a proximal direction or a distal direction along the central axis with the therapy delivery element is implanted within the living body.
18. The therapy assembly of claim 17 , wherein the at least two or more fixation structures includes major surfaces generally parallel with, and extending generally radially outwardly from, a central axis of the therapy delivery element.
19. The therapy assembly of claim 18 , comprising at least two fixation assemblies arranged axially offset from one another along the therapy delivery element, wherein each fixation assembly includes at least two of the fixation structures, and wherein the at least two fixation assemblies are rotationally offset from one another so the major surfaces of the fixation structures on at least two fixation assemblies are out-of-plane from one another.