Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication
Anchoring devices for affixing an implanted lead at a target location in a patient are provided herein. Such anchoring devices include a helical body having a plurality of tines extending laterally outward from the lead when deployed that engage tissue to inhibit axial movement of the implanted lead. The plurality of tines are biased towards the laterally extended deployed configuration and fold inward towards the lead to a delivery configuration to facilitate delivery of the lead through a sheath. The tines may be angled in a proximal direction or in both proximal and distal directions and may include various features to assist in visualization and delivery of the lead.
1. An anchor for anchoring an implanted neurostimulation lead at a tissue location in a body of a patient, the anchor comprising:
a helical body extending helically along a longitudinal axis thereof; and
a plurality of tines extending from the helical body, wherein each of the plurality of tines is biased toward a deployed configuration and resiliently deflectable for a delivery configuration,
wherein the helical body and the plurality of tines are formed from a single integral tube,
wherein in the deployed configuration, the plurality of tines extend laterally away from the longitudinal axis of the helical body, and in the delivery configuration, the plurality of tines are folded inward toward the longitudinal axis of the helical body to facilitate delivery of a lead during implantation, and
wherein the anchor is molded from a polyurethane based material having a shore hardness in a range between 50A and 80D.
2. The anchor of claim 1 , wherein the anchor is configured such that when attached to a lead body in the delivery configuration, each of the plurality of tines is configured to be folded directly against the lead body.
3. The anchor of claim 2 , wherein each of the plurality of tines is configured to be folded against the lead body without overlapping a section of the helical body.
4. The anchor of claim 1 , wherein the plurality of tines are substantially flush with the helical body of the anchor when in the delivery configuration.
5. The anchor of claim 1 , wherein each of the plurality of tines has a rectangular shape.
6. The anchor of claim 1 , wherein the anchor is dimensioned such that, when attached to a lead body and in the delivery configuration, the anchor has a cross sectional profile sufficiently small to facilitate delivery through a 5 French sheath.
7. The anchor of claim 1 , wherein the helical body and the plurality of tines are integrally formed of a common material.
8. The anchor of claim 1 , wherein the anchor is formed of a material with sufficient stiffness so that, when attached to an implanted lead and in the deployed configuration, engagement of tissue with the plurality of tines inhibits axial movement of the implanted lead when implanted in a tissue of the patient at a target location.
9. The anchor of claim 1 , wherein, in the deployed configuration, each of the plurality of tines is angled in a proximal direction.
10. An anchor for anchoring an implanted neurostimulation lead at a tissue location in a body of a patient, the anchor comprising:
a helical body extending helically along a longitudinal axis thereof; and
a plurality of tines extending from the helical body, wherein each of the plurality of tines is biased toward a deployed configuration and resiliently deflectable for a delivery configuration,
wherein in the delivery configuration, the plurality of tines are substantially flush with the helical body,
wherein in the deployed configuration, the plurality of tines extend laterally away from the longitudinal axis of the helical body, and in the delivery configuration, the plurality of tines are folded inward toward the longitudinal axis of the helical body to facilitate delivery of a lead during implantation, and
wherein the anchor is molded from a polyurethane based material having a shore hardness in a range between 50A and 80D.
11. The anchor of claim 10 , wherein the anchor is configured such that when attached to a lead body in the delivery configuration, each of the plurality of tines is configured to be folded directly against the lead body.
12. The anchor of claim 11 , wherein each of the plurality of tines is configured to be folded against the lead body without overlapping a section of the helical body.
13. The anchor of claim 10 , wherein each of the plurality of tines has a rectangular shape.
14. The anchor of claim 10 , wherein the anchor is dimensioned such that, when attached to a lead body and in the delivery configuration, the anchor has a cross sectional profile sufficiently small to facilitate delivery through a 5 French sheath.
15. The anchor of claim 10 , wherein the helical body and the plurality of tines are integrally formed of a common material.
16. The anchor of claim 10 , wherein the anchor is formed of a material with sufficient stiffness so that, when attached to an implanted lead and in the deployed configuration, engagement of tissue with the plurality of tines inhibits axial movement of the implanted lead when implanted in a tissue of the patient at a target location.
17. The anchor of claim 10 , wherein, in the deployed configuration, each of the plurality of tines is angled in a proximal direction.
18. The anchor of claim 10 , wherein, in the deployed configuration, each of the plurality of tines extend laterally outward from the longitudinal axis at an angle between 30 and 80 degrees from the longitudinal axis.