Lead implant fixation mechanism

• US 10,603,483 B2
• Filed: 04/25/2017
• Issued: 03/31/2020
• Est. Priority Date: 04/28/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Seifert, Kevin R., Pistella, Maggie J., Brostrom, Thomas D., Anderson, Keith D., Morgan, Gareth
• Primary Examiner(s): Evanisko, George R
• Application Number:
  US15/496,270
• Publication Number:
  US 20170312494A1
• Time in Patent Office: 1,071 Days
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

A fixation mechanism of an implantable lead includes a plurality of depressions of an outermost surface of the lead and a relatively flexible sleeve mounted around the outermost surface. The depressions are spaced apart from one another along a length, and each extends circumferentially, wherein a longitudinal center-to-center spacing between each adjacent depression is uniform along the length, and each depression is of substantially the same size. The sleeve has an internal surface in sliding engagement with the outermost surface of the lead, and an external surface, in which suture grooves are formed. A longitudinal center-to-center spacing between adjacent suture grooves may be substantially the same as, or a multiple of, the longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead. The sleeve may also include a ridge protruding from the internal surface, aligned with, or offset (by center-to-center spacing of depressions) from, the grooves.

Claims

1. An implantable medical electrical lead comprising:

a connector;

an electrode;

an elongate insulation body extending between the connector and the electrode, the body surrounding a longitudinal axis;

an elongate conductor extending within the insulation body and coupling the electrode to the connector; and

a fixation mechanism comprising;

an outermost surface of the lead overlaying the insulation body and surrounding the longitudinal axis, the outermost surface including a plurality of depressions spaced apart from one another along a length of the body, wherein the outermost surface of the lead surrounds one or more lumens and each depression does not extend to any of the one or more lumens, wherein each depression defines an arc having an arc center on the longitudinal axis, and wherein each depression extends around at least part of the circumference of the body; and

a relatively flexible sleeve mounted around the outermost surface of the lead and surrounding the longitudinal axis, the sleeve comprising an internal surface, an external surface, and at least two suture grooves formed in the external surface and extending around a circumference thereof, the internal surface being in sliding engagement with the outermost surface of the lead, and a longitudinal center-to-center spacing between adjacent suture grooves being substantially the same as, or a multiple of, a longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead,

wherein the sleeve is configured to form an interlocking engagement between the internal surface of the sleeve and at least one of the depressions of the outermost surface of the lead, wherein when the sleeve is configured to form the interlocking engagement, a suture applying a constricting force around the circumference of one of the suture grooves generates a protrusion of the internal surface of the sleeve and the protrusion inserts into the depression of the outermost surface of the lead.

2. The lead of claim 1, wherein the longitudinal center-to-center spacing between each adjacent depression is uniform along the length of the body.

3. The lead of claim 1, wherein the outermost surface of the lead is a tubing member overlaying the insulation body, the plurality of depressions being formed in the tubing member.

4. The lead of claim 1, wherein the outermost surface of the lead comprises a coiled member, overlaying the insulation body, and wherein the plurality of depressions are formed by the coiled member and portions of the insulation body between turns of the coiled member.

5. The lead of claim 1, wherein a first depression extends around a first arc of the circumference of the body and a second depression extends around a second arc of the circumference of the body, and wherein the first arc has a first midpoint and the second arc has a second midpoint, and wherein the first midpoint is angularly displaced from the second midpoint around the circumference of the body.

6. The lead of claim 1, wherein the outermost portion of the lead along which the plurality of depressions are spaced apart is about four inches long.

7. The lead of claim 1 wherein each depression extends around at least one-quarter of the circumference of the body.

8. The lead of claim 1 wherein each depression is a circular depression extending 360 degrees around the body.

9. An implantable medical electrical lead comprising:

a connector,

an electrode,

an elongate insulation body extending between the connector and the electrode,

an elongate conductor extending within the insulation body and coupling the electrode to the connector, and

a fixation mechanism, the fixation mechanism comprising;

an outermost surface of the lead overlaying the insulation body, the outermost surface including a plurality of depressions spaced apart from one another along a length of the body, each depression extending around at least part of the circumference of the body, a longitudinal center-to-center spacing between each adjacent depression being uniform along the length, and each depression being of substantially the same size; and

a relatively flexible sleeve mounted around the outermost surface of the lead, the sleeve comprising an internal surface, an external surface, at least two suture grooves formed in the external surface and extending around a circumference thereof, and at least two ridges protruding from the internal surface, the internal surface being in sliding engagement with the outermost surface of the lead, each ridge being sized to fit within one of the depressions of the outermost surface of the lead, and each ridge being longitudinally aligned with a corresponding suture groove.

10. The lead of claim 9, wherein a longitudinal center-to-center spacing between adjacent suture grooves of the sleeve of the fixation mechanism is substantially the same as, or a multiple of, the longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead.

11. The lead of claim 9, wherein a profile defined by the internal surface of the sleeve of the fixation mechanism is generally elliptically shaped.

12. The lead of claim 11, wherein the internal surface of the sleeve includes a flat aspect, from which the ridges protrude.

13. The lead of claim 9, wherein the outermost surface of the lead comprises a tubing member overlaying the insulation body, the plurality of depressions being formed in the tubing member.

14. The lead of claim 9, wherein the outermost surface of the lead comprises a coiled member, overlaying the insulation body, and wherein the plurality of depressions are formed by the coiled member and portions of the insulation body between turns of the coiled member.

15. The lead of claim 9, wherein each depression of the outermost surface does not extend all the way around a circumference of the insulation body, and adjacent depressions are circumferentially offset from one another.

16. The lead of claim 9, wherein the length of the insulation body, along which the plurality of depressions are spaced apart, is about four inches long.

17. The lead of claim 9, wherein:

the sleeve of the fixation mechanism further comprises a contractible segment extending between a first end of the sleeve and a second end of the sleeve, the contractible segment constricting around the insulation body when the second end is pulled longitudinally away from the first end;

the internal and external surfaces of the sleeve are divided between the first and second ends of the sleeve;

a first of the at least two suture grooves and a first of the at least two ridges are located at the first end of the sleeve; and

a second of the at least two suture grooves and a second of the at least two ridges are located at the second end of the sleeve.

18. An implantable medical electrical lead comprising:

a connector;

an electrode;

an elongate insulation body extending between the connector and the electrode, the insulation body including an outermost surface integral with the insulation body and the outermost surface including a plurality of depressions extending around at least a portion of the circumference of the insulation body, wherein the outermost surface of the insulation body surrounds one or more lumens and the plurality of depressions does not extend to any of the one or more lumens;

an elongate conductor extending within the insulation body and coupling the electrode to the connector; and

a relatively flexible sleeve mounted around the outermost surface of the insulation body and the plurality of depressions, the sleeve comprising an internal surface, an external surface, and at least one suture groove formed in the external surface and extending around a circumference of the sleeve, the internal surface configured to be moveable with respect to the outermost surface of the insulation body before sutured using the suture groove and configured to engage with at least one depression of the plurality of depressions of the outermost surface of the insulation body when sutured using the suture groove such that the internal surface of the sleeve is fixated with respect to the outermost surface of the insulation body by the interaction of the internal surface of the sleeve and the at least one depression of the outermost surface of the insulation body.

19. An implantable medical electrical lead comprising:

a connector;

an electrode;

an elongate insulation body extending between the connector and the electrode;

an elongate conductor extending within the insulation body and coupling the electrode to the connector; and

a fixation mechanism comprising;

an outermost surface of the lead overlaying the insulation body, the outermost surface including a plurality of depressions spaced apart from one another along a length of the body, each depression extending around at least part of the circumference of the body; and

a relatively flexible sleeve mounted around the outermost surface of the lead, the sleeve comprising an internal surface, an external surface, and at least two suture grooves formed in the external surface and extending around a circumference thereof, the internal surface being in sliding engagement with the outermost surface of the lead, and a longitudinal center-to-center spacing between adjacent suture grooves being substantially the same as, or a multiple of, a longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead, wherein the sleeve further comprises a ridge protruding from the internal surface, the ridge being sized to fit within one of the plurality of depressions of the outermost surface of the lead.

20. The lead of claim 19, wherein the ridge is longitudinally aligned with one of the suture grooves.

21. The lead of claim 19, wherein the ridge is longitudinally spaced apart from the suture grooves, a spacing between the ridge and a closest one of the suture grooves being substantially the same as the longitudinal center-to-center spacing between the suture grooves.

22. The lead of claim 19, wherein a profile defined by the internal surface of the sleeve is elliptically shaped, the internal surface of the sleeve includes a flat aspect, and the ridge protrudes from the flat aspect.

23. The lead of claim 22, wherein the sleeve is configured such that deformation of the sleeve disengages the ridge from the one of the plurality of depressions.