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

• US 9,427,574 B2
• Filed: 01/08/2016
• Issued: 08/30/2016
• 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 M
• Application Number:
  US14/991,649
• Publication Number:
  US 20160121105A1
• Time in Patent Office: 235 Days
• US Class Current: 1/1
• 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 neurostimulation lead comprising:

an implantable lead having a plurality of conductors disposed within a lead body, the plurality of conductors extending from a proximal end of the lead to a plurality of neurostimulation electrodes disposed at or near a distal end of the lead, each conductor of the plurality corresponding to a respective neurostimulation electrode of the plurality of neurostimulation electrodes; and

a single anchor coupled with the lead body and configured for anchoring the implanted lead within a body of a patient, wherein the lead includes only the single anchor, the anchor comprising;

a helical body extending helically on the outside of the lead body along a longitudinal axis and disposed along a recessed portion of the lead body, and

a plurality of tines extending from the helical body, wherein each of the plurality of tines is biased toward a deployed configuration, wherein in the deployed configuration, the plurality of tines extend laterally away from the longitudinal axis, and the plurality of tines are resiliently deflectable toward a delivery configuration in which the plurality of tines are folded inward toward the longitudinal axis to facilitate delivery of the neurostimulation lead during implantation,

wherein the recessed portion, the helical body and the plurality of tines are dimensioned to facilitate fine-tuned placement of the lead in delivery and deployment.

2. The neurostimulation lead of claim 1, wherein the anchor is configured such that in the delivery configuration, each of the plurality of tines is folded against the lead body.

3. The neurostimulation lead of claim 1, wherein the anchor is dimensioned such that, in the delivery configuration, the anchor has a cross sectional profile compatible with a sheath having a 5 French diameter or higher.

4. The neurostimulation lead of claim 1, wherein the helical body and the plurality of tines are integrally formed.

5. The neurostimulation lead of claim 1, wherein the anchor is formed of a material with sufficient stiffness so that engagement of tissue with the plurality of tines inhibits axial movement of the lead when implanted in a tissue of the patient at the target location.

6. The neurostimulation lead of claim 5, wherein the anchor is molded from a polyurethane based material having a shore hardness in a range from 50A to 80D.

7. The neurostimulation lead of claim 1, wherein the anchor is dimensioned so that the helical body extends a length ranging from 10 mm to 30 mm along a distal portion of the lead body when coupled thereon.

8. The neurostimulation lead of claim 1, wherein the anchor is disposed entirely proximal of the plurality of neurostimulation electrodes.

9. The neurostimulation lead of claim 1, wherein the anchor is the one and only anchor on the neurostimulation lead.

10. The neurostimulation lead of claim 1, wherein, in the deployed configuration, each of the plurality of tines extends laterally outward from the longitudinal axis a distance within range from 1 mm to 4 mm.

11. The neurostimulation lead of claim 1, wherein each of the plurality of tines range from 1.5 mm to 3 mm in length and each of the plurality of tines range from 0.5 mm to 2.0 mm in width.

12. The neurostimulation lead of claim 11, wherein the plurality of tines include tines of varying length or width.

13. The neurostimulation lead of claim 1, wherein the anchor is dimensioned so that a proximal and distal end of the helical body abut against proximal and distal ends of the recessed portion.

14. The neurostimulation lead of claim 13, wherein each of the plurality of tines has an elongate shape and has rounded or chamfered corners and/or edges so as to inhibit tissue damage.

15. The neurostimulation lead of claim 1, wherein, in the deployed configuration, each of the plurality of tines extends laterally outward from the longitudinal axis at an angle ranging from 30 to 80 degrees from the longitudinal axis.

16. The neurostimulation lead of claim 1, wherein, in the deployed configuration, each of the plurality of tines are angled in a proximal direction.

17. The neurostimulation lead of claim 1, wherein, in the deployed configuration, the plurality of tines are angled in both a proximal direction and a distal direction.

18. The neurostimulation lead of claim 1, wherein, when in the delivery configuration, the anchor has a cross sectional profile of 2 mm or less.

23. The neurostimulation lead of claim 1, wherein the plurality of tines are distributed along the helical body so as to facilitate fine-tuned placement of the lead upon deployment.

19. A neurostimulation lead comprising:

an implantable lead having a lead body and one or more neurostimulation electrodes disposed at or near a distal end of the lead; and

a single anchor coupled to the lead body, wherein the anchor is formed as a single integral component and configured for anchoring the implanted lead within a body of a patient, the anchor comprising;

a spiral body wrapped on a portion of the lead body along a longitudinal axis thereof and disposed entirely within a recessed portion of the lead body, and

a plurality of tines extending from the spiral body, wherein each of the plurality of tines extends laterally outward and is resiliently deflectable to allow for a reduced profile delivery configuration when constrained by a sheath to facilitate delivery of the neurostimulation lead during implantation,

wherein the recessed portion, the spiral body and the plurality of tines are dimensioned to facilitate fine-tuned placement of the lead in delivery and deployment.

22. The neurostimulation lead of claim 19, wherein the anchor is configured such that in the delivery configuration, each of the plurality of tines is folded against the lead body so as to provide improved consistency in delivery profile along the anchor to facilitate fine-tuned lead placement.

24. The neurostimulation lead of claim 19, wherein the plurality of tines are distributed along the spiral body so as to facilitate fine-tuned placement of the lead upon deployment.

20. A neurostimulation lead comprising:

an implantable lead having a lead body and at least four neurostimulation electrodes disposed at or near a distal end of the lead; and

an anchor coupled with the lead body and configured for anchoring the lead within a body of a patient to maintain the at least four neurostimulation electrodes at or near a target tissue location, the anchor comprising;

a helical body attached to the lead body along a recessed portion thereof and extending helically along a longitudinal axis thereof, and

a plurality of tines extending from the helical body, wherein each of the plurality of tines extends laterally away from longitudinal axis of the helical body, when in a deployed configuration, so as to facilitate anchoring of the lead, and wherein each of the plurality of tines is deflectable inward towards the lead body in a constrained configuration to allow a reduced delivery profile to facilitate implantation of the lead

wherein the anchor is dimensioned so that an outer surface of the helical body is substantially flush with an outer surface of the lead body outside of the recessed portion so as to improve ease and accuracy in delivery and positioning during deployment to facilitate fine-tuned lead placement.

21. The neurostimulation lead of claim 20, wherein the anchor is configured such that in the delivery configuration, each of the plurality of tines is folded against the lead body so as to provide improved consistency in delivery profile along the anchor to facilitate fine-tuned lead placement.

25. The neurostimulation lead of claim 20, wherein the plurality of tines are distributed along the helical body so as to facilitate fine-tuned placement of the lead upon deployment.