FIXATION COMPONENTS FOR IMPLANTABLE MEDICAL DEVICES AND ASSOCIATED DEVICE CONSTRUCTION

• US 20120053665A1
• Filed: 08/24/2011
• Published: 03/01/2012
• Est. Priority Date: 08/25/2010
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Stolz, Brian T., Tronnes, Carole A.
• Granted Patent: US 8,948,882 B2
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A fixation component for a medical electrical lead includes a tubular sidewall that has an outer surface from which a plurality of deformable barb-like projections extend, each projection being in proximity to an aperture that extends through the sidewall. The projections are spaced apart from one another along a length of the component, and each extends from a first end, attached to the sidewall, in proximity to an edge of the corresponding aperture, to a second, free end, spaced apart from the outer surface of the sidewall, when the projection is un-deformed. The outer surface of the sidewall preferably includes reduced diameter end portions, to maintain a relatively low profile, when tubing members overlap thereon to secure the component around a body of the medical electrical lead. The body of the lead may include a conductor coil whose outer surface is directly overlaid by the component.

Claims

1. A fixation component for a medical electrical lead, the component comprising:

an elongate tubular sidewall including an inner surface and an outer surface, the inner surface defining an elongate lumen that has a uniform diameter along an entire length of the component, to receive a body of the lead, and the outer surface including a central portion and two end portions extending longitudinally from either end of the central portion, the two end portions having a diameter that is less than that of the central portion;

a plurality of deformable barb-like projections being spaced apart from one another along a length of the central portion of the outer surface of the tubular sidewall, each projection including a first end attached to the tubular sidewall and a second, free end spaced apart from the outer surface of the tubular sidewall, when un-deformed; and

an aperture corresponding to each of the plurality of barb-like projections, each aperture extending through the elongate tubular sidewall from the central portion of the outer surface to the inner surface, and each aperture having a width and a length, the length of each aperture being defined from a first edge thereof to an opposing second edge thereof, the first edge of each aperture being located in proximity to the attached end of the corresponding projection, and the length and the width of each aperture being sized so that each aperture receives the corresponding projection therein, when the projection is deformed.

2. The component of claim 1, wherein the plurality of barb-like projections are arranged in at least one longitudinally extending column, such that each projection of each of the at least one column extends outward in the same general direction.

3. The component of claim 2, wherein the at least one column of barb-like projections includes a first column and a second column, the first and second columns being displaced circumferentially from one another and longitudinally from one another resulting in a staggered arrangement of the plurality of barb-like projections.

4. The component of claim 1, wherein the length of the central portion of the outer surface of the tubular sidewall is greater than approximately 0.5 inch (12.7 mm).

5. The component of claim 1, wherein a length of each end portion of the outer surface of the tubular sidewall is approximately 0.1 inch (2.54 mm) and the diameter of each of the end portions of the outer surface is approximately 0.005 inch (0.127 mm) less than that of the central portion.

6. The component of claim 1, wherein the length of each aperture is greater than a length of the corresponding barb-like projection, from the first end thereof to the second end thereof.

7. The component of claim 1, wherein the second edge of each aperture tapers away from the corresponding opposing first edge.

8. The component of claim 1, wherein each of the plurality of barb-like projections has an arcuate cross-section that curves in a direction approximately orthogonal to an extension thereof between the corresponding first and second ends, so that each projection has a concave inner surface facing toward the corresponding aperture and a convex outer surface facing away from the aperture.

9. The component of claim 8, wherein the second, free end of each of the plurality of barb-like projections is tapered.

10. The component of claim 1, wherein an entirety of the component is formed from liquid silicone rubber.

11. An implantable medical electrical lead comprising:

a proximal connector terminal;

a distal electrode;

an elongate body formed at least in part by a conductor that extends between the proximal connector terminal and the distal electrode and electrically couples the connector terminal to the distal electrode; and

a fixation component according to claim 1 mounted around the elongate body in proximity to and proximal to the electrode.

12. The lead of claim 11, wherein the plurality of barb-like projections of the fixation component are arranged in a first longitudinally extending column and a second longitudinally extending column, the first and second columns being displaced circumferentially from one another and longitudinally from one another resulting in a staggered arrangement of the plurality of barb-like projections.

13. The lead of claim 11, wherein the length of the central portion of the outer surface of the tubular sidewall of the fixation component is greater than approximately 0.5 inch (12.7 mm).

14. The lead of claim 11, wherein the second edge of each aperture of the fixation component tapers away from the corresponding opposing first edge.

15. The lead of claim 11, wherein each of the plurality of barb-like projections of the fixation component has an arcuate cross-section that curves in a direction approximately orthogonal to an extension thereof between the corresponding first and second ends, so that each projection has a concave inner surface facing toward the corresponding aperture and a convex outer surface facing away from the aperture.

16. The lead of claim 15, wherein the second, free end of each of the plurality of barb-like projections of the fixation component is tapered.

17. The lead of claim 11, wherein an entirety of the fixation component is formed from liquid silicone rubber.

18. A temporary implantable medical electrical lead comprising:

a proximal connector terminal;

one or more distal electrodes;

an elongate body formed, at least in part, by a conductor coil that extends between the proximal connector terminal and the one or more distal electrodes and electrically couples the connector terminal to the one or more electrodes, the conductor coil including one or more wound wire filars, each wire filar including an insulative layer for electrical isolation; and

a fixation component directly overlaying an outer surface of the conductor coil in proximity to and proximal to the one or more distal electrodes, the fixation component including an elongate tubular sidewall, a plurality of deformable barb-like projections extending outward from an outer surface of the tubular sidewall, and an aperture corresponding to each projection and extending through the sidewall, each projection including a first end attached to the sidewall in proximity to an edge of the corresponding aperture, and a second, free end spaced apart from the outer surface of the sidewall, when un-deformed, and each aperture exposing the overlaid conductor coil to an environment outside the outer surface of the tubular sidewall of the fixation component.

19. The lead of claim 18, further comprising:

a pair of tubular members closely conforming to the outer surface of the tubular sidewall of the fixation component and to the outer surface of the conductor coil; and

wherein the outer surface of the tubular sidewall of the fixation component includes a central portion, a proximal end portion and a distal end portion, the proximal and distal end portions extending from either end of the central portion;

a first of the pair of tubular members overlaps the proximal end portion of the outer surface of the fixation component and a portion of the outer surface of the conductor coil that extends proximally from the proximal end portion; and

a second of the pair of tubular members overlaps the distal end portion of the outer surface of the fixation component and another portion of the outer surface of the conductor coil that extends distally from the distal end portion.

20. The lead of claim 19, wherein the closely conforming tubular members do not overlap the central portion of the outer surface of the tubular sidewall of the fixation component, and an outer surface of each of the closely conforming tubular members is approximately flush with the central portion of the outer surface of the central portion.

21. The lead of claim 19, wherein:

a length of the central portion of the outer surface of the tubular sidewall of the fixation component is greater than approximately 0.5 inch (12.7 mm); and

the plurality of deformable barb-like projections of the fixation component are spaced apart from one another along the length of the central portion.

22. The lead of claim 19, wherein:

an entirety of the fixation component is formed by molded liquid silicon rubber; and

each of the pair of closely conforming tubular members is formed by heat shrinkable polyester tubing.

23. The lead of claim 19, wherein:

the first of the pair of tubular members includes a proximal terminal end and extends proximally from the proximal end portion of the outer surface of the fixation component over the portion of the outer surface of the conductor coil to the proximal terminal end; and

another portion of the outer surface of the conductor coil, just proximal to the proximal terminal end of the first of the pair of tubular members is exposed to the environment outside the outer surface of the fixation component.

24. The lead of claim 18, wherein the plurality of barb-like projections of the fixation component are arranged in at least one longitudinally extending column, such that each projection of each of the at least one column extends outward in the same general direction.

25. The lead of claim 24, wherein the at least one column of barb-like projections includes a first column and a second column, the first and second columns being displaced circumferentially from one another and longitudinally from one another resulting in a staggered arrangement of the plurality of barb-like projections.

26. The lead of claim 18, wherein a perimeter of each aperture of the fixation component is sized to receive the corresponding deformable barb-like projection therein, when the projection is deformed.

27. The lead of claim 26, wherein a length of each aperture, from the edge, in the proximity of which the first end of the corresponding deformable barb-like projection is attached, to an opposing edge, is greater than a length of the corresponding projection from the first end thereof to the second end thereof.