Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indication

• US 9,802,038 B2
• Filed: 08/14/2015
• Issued: 10/31/2017
• Est. Priority Date: 08/15/2014
• Status: Active Grant

• Current Assignee: Axonics, Inc.
• Original Assignee: Axonics Modulation Technologies, Inc.
• Inventors: Lee, Henry, Hwu, Alexander
• Primary Examiner(s): Voorhees, Catherine
• Application Number:
  US14/827,074
• Publication Number:
  US 20160045724A1
• Time in Patent Office: 809 Days
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: B23K 2103/14 Titanium or alloys thereof
• CPC Class Codes: B23K 2103/18 Dissimilar materials
• CPC Class Codes: B23K 2103/26 Alloys of Nickel and Cobalt and Chromium
• CPC Class Codes: B23K 26/242 Fillet welding, i.e. involving a weld of substantially triangular cross section joining two parts
• CPC Class Codes: B23K 26/38 by boring or cutting
• CPC Class Codes: B23K 26/40 taking account of the properties of the material involved
• CPC Class Codes: B29C 45/14065 Positioning or centering articles in the mould
• CPC Class Codes: B29C 45/14598 Coating tubular articles
• CPC Class Codes: B29C 45/14778 the article consisting of a material with particular properties, e.g. porous, brittle
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

Anchoring devices and methods for affixing an implanted lead of a neurostimulation system at a target location in a patient are provided herein. Such anchoring devices includes 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. The anchor may be formed according to various methods, including laser cutting of a tubular section along with heat or reflow to set the material with the anchor in the deployed configuration and injection molding.

Claims

1. A method of anchoring an implanted neurostimulation lead of a neurostimulation system in a patient, the method comprising:

providing a neurostimulation lead having one or more neurostimulation electrodes and an anchor proximal the one or more electrodes, wherein the anchor includes a helical body wrapped along a length of the lead and a plurality of tines attached to the helical body folded inward against a lead body and constrained by a sheath, wherein the helical body attaches to the lead body in a recessed portion thereof so as to allow for a reduced delivery profile;

advancing the lead through a tissue of a patient to a target location while the plurality of tines are folded inward against the lead body constrained by the sheath;

resiliently deploying the plurality of tines to a deployed configuration extended laterally outward from the helical body by withdrawing the sheath; and

anchoring the neurostimulation lead at the target location by engaging the plurality of tines in the deployed configuration against adjacent tissues thereby inhibiting axial movement of the implanted lead.

2. The method of claim 1 wherein the target location comprises a sacral nerve for a neurostimulation treatment of overactive bladder (OAB) so that advancing the lead through the tissue comprises advancing the lead through an S3 foramen until the one or more neurostimulation electrodes are positioned at the sacral nerve.

3. The method of claim 2, wherein anchoring the neurostimulation lead by engaging the plurality of tines against adjacent tissues comprises engaging tissues within and/or adjacent the S3 foramen.

4. The method of claim 1, wherein resiliently deploying the plurality of tines comprises withdrawing the sheath after positioning one or more neurostimulation electrodes of the lead along a target nerve.

5. The method of claim 1, wherein resiliently deploying the plurality of tines comprises observing one or more radiopaque markers on the anchor with visualization techniques.

6. The method of claim 1, wherein resiliently deploying the plurality of tines comprises observing a separation of a first radiopaque markers on at least one tine of the plurality of tines and a second radiopaque marker on the helical body, wherein the separation is indicative of an extent of deployment.

7. The method of claim 4, wherein the one or more neurostimulation electrodes comprises a plurality of electrodes, the method further comprising:

positioning the lead so that a set of the plurality of electrodes are disposed along the targeted nerve.

8. The method of claim 7, wherein anchoring the neurostimulation lead comprises maintaining the set of the plurality of electrodes along the targeted nerve by engagement of the plurality of tines in the deployed configuration with adjacent tissues.

9. The method of claim 1, wherein during advancing the lead, the plurality of tines are folded against the lead body without overlapping with one another so as allow for a reduced delivery profile.

10. The method of claim 1, wherein the recessed portion is defined so that the anchor is about flush with an outer surface of the lead body outside of the recessed portion.

11. The method of claim 1, wherein the sheath has a diameter of 5 French or higher.

12. The method of claim 1, wherein the anchor has a cross sectional profile of about 2 mm or less.

13. A method of anchoring an implanted neurostimulation lead of a neurostimulation system in a patient, the method comprising:

providing a neurostimulation lead having one or more neurostimulation electrodes and a plurality of tines extending outwardly from a leady body of the lead;

advancing the lead through a tissue of a patient to a target location while the plurality of tines are folded inward toward the lead body constrained by a sheath;

resiliently deploying the plurality of tines to a deployed configuration extended laterally outward from the lead body by withdrawing the sheath;

coupling neurostimulation lead to a pulse generator; and

anchoring the neurostimulation lead at the target location by engaging the plurality of tines in the deployed configuration against adjacent tissues thereby inhibiting axial movement of the implanted lead and relieving strain within a proximal portion of the lead proximal of the one or more neurostimulation electrodes with a strain relief member comprising a helical element wrapped along the proximal portion of the lead adjacent a junction of the neurostimulation lead and the pulse generator.

14. The method of claim 13, wherein the strain relief member has variable stiffness along a longitudinal axis thereof so that relieving strain is variable along the proximal portion of the lead.

15. A method of anchoring an implanted neurostimulation lead of a neurostimulation system in a patient, the method comprising:

providing a neurostimulation lead having one or more neurostimulation electrodes and an anchor proximal the one or more electrodes, wherein the anchor includes a helical body wrapped along a length of the lead and a plurality of tines attached to the helical body;

advancing the lead through a tissue of a patient to a target location while the plurality of tines are folded inward toward the lead body;

resiliently deploying the plurality of tines to a deployed configuration extended laterally outward from the helical body by twisting the lead body in one direction, the plurality of tines being configured to fold inward along a helical or inclined axis; and

anchoring the neurostimulation lead at the target location by engaging the plurality of tines in the deployed configuration against adjacent tissues thereby inhibiting axial movement of the implanted lead.

16. The method of claim 15, wherein during advancing the lead, the plurality of tines are folded against the lead body without overlapping the anchor so as to allow for a reduced delivery profile.

17. The method of claim 15, wherein anchoring the neurostimulation lead further comprises relieving strain within a portion of the lead proximal of the one or more neurostimulation electrodes with a strain relief member disposed along the proximal portion of the lead adjacent a junction of the lead and an external pulse generator.

18. The method of claim 15 further comprising:

removing the lead after deployment of the anchor by retracting the plurality of tines from a deployed configuration by twisting the lead body in an opposite direction as the one direction to facilitate folding the plurality of tines inward along the helical or inclined axis.

19. A method of anchoring an implanted neurostimulation lead of a neurostimulation system in a patient, the method comprising:

providing a neurostimulation lead having one or more neurostimulation electrodes and an anchor proximal the one or more electrodes, wherein the anchor includes a helical body wrapped along a length of the lead and a plurality of tines attached to the helical body;

advancing the lead through a tissue of a patient to a target location while the plurality of tines are folded inward toward the lead body;

resiliently deploying the plurality of tines to a deployed configuration extended laterally outward from the helical body; and

removing the lead after deployment of the anchor by retracting the plurality of tines from a deployed configuration by twisting the lead body in one direction, the plurality of tines being configured to fold inward along a helical or inclined axis.