Lead with inflatable fixation mechanism

• US 7,765,015 B2
• Filed: 01/12/2007
• Issued: 07/27/2010
• Est. Priority Date: 01/12/2007
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: D'aquanni, Peter J., Johnson, Eric T., Soltis, Brian D., Tockman, Bruce A., Stalker, Kent C. B., Smith, Gayla A.
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US11/622,810
• Publication Number:
  US 20080172118A1
• Time in Patent Office: 1,292 Days
• Field of Search: None
• US Class Current: 607/126
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A medical electrical lead configured for use in stimulating the left side of the heart (i.e., the left ventricle). In one embodiment, the lead includes an elongate lead body including an inner surface. An inflatable member is disposed on the outer surface of the body between its proximal and distal ends, the inflatable member being adapted when inflated to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end of the lead therein. The lead further includes a conductive member extending from the proximal end toward the distal end, and an inner insulating layer positioned between the conductive member and the inner surface of the body. Separation between the inner insulating layer and the inner surface of the body defines an inflation lumen in fluid communication with the inflatable member.

Claims

1. A medical electrical lead comprising:

an elongate lead body having a proximal end, a distal end, an outer surface, and an inner surface, the body being made from an electrically insulative material and dimensioned such that the distal end can be implanted in a coronary sinus or coronary vein;

an inflatable member disposed on the outer surface of the body between the proximal and distal ends, the inflatable member adapted to assume a deflated state and an inflated state in which the inflatable member is adapted to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end therein, the inflatable member including a resilient membrane attached to and extending partially circumferentially around a portion of the lead body;

a conductive member extending from at least the proximal end toward the distal end of the body;

an inner insulating layer disposed between the conductive member and the inner surface of the body and extending from the proximal end toward the distal end;

an inflation lumen between the inner insulating layer and the inner surface of the body in fluid communication with the inflatable member; and

an electrode on the body electrically coupled to the conductive member.

2. The lead of claim 1 wherein the resilient membrane extends from about 90 degrees to about 270 degrees around the portion of the lead body, and wherein in the inflated state the inflatable member is adapted to bias the electrode toward the surface of the coronary sinus or coronary vein.

3. The lead of claim 1 wherein the inflatable member includes a resilient membrane attached to the outer surface of the body and extending around a portion of the body in a generally helical configuration.

4. The lead of claim 1 and further comprising a portal extending through the body proximate the proximal end, the portal adapted to facilitate introduction of a fluid into the inflation lumen.

5. The lead of claim 4 and further comprising a sealing feature coupled to the portal to substantially prevent loss of fluid through the portal.

6. The lead of claim 4 and further comprising an orifice extending through the lead body to fluidly couple the inflatable member and the inflation lumen.

7. The lead of claim 1 wherein the inflatable member is made substantially from a material selected from the group consisting of silicone, polyurethane, polyether block amide, and a bio-absorbable polymer.

8. The lead of claim 1 wherein the lumen is an elongate tubular member coupled to a portal located proximate the proximal end of the lead body.

9. A medical electrical lead comprising:

an elongate lead body having a proximal end, a distal end, an outer surface, and an inner surface, the body being made from an electrically insulative material and dimensioned such that the distal end can be implanted in a coronary sinus or coronary vein;

an inflatable member disposed on the outer surface of the body between the proximal and distal ends, the inflatable member adapted to assume a deflated state and an inflated state in which the inflatable member is adapted to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end therein;

a conductive member extending from at least the proximal end toward the distal end of the body, the conductive member including an insulative coating, wherein separation between the insulative coating and the inner surface of the body defines an inflation lumen in fluid communication with the inflatable member; and

an electrode on the body electrically coupled to the conductive member.

10. The lead of claim 9 and further comprising at least one spacing member disposed between the insulative coating and the inner surface of the lead body, the spacing member adapted to maintain the separation between the insulative coating and the inner surface of the body.

11. The lead of claim 9 and further comprising a portal extending through the body proximate the proximal end, the portal adapted to facilitate introduction of a fluid into the inflation lumen.

12. The lead of claim 11 and further comprising a sealing feature coupled to the portal to substantially prevent loss of fluid through the portal.

13. The lead of claim 11 and further comprising an orifice extending through the lead body to fluidly couple the inflatable member and the inflation lumen.

14. A medical electrical lead comprising:

an elongate lead body having a proximal end, a distal end, an outer surface, and an inner surface, the body being made from an electrically insulative material and dimensioned such that the distal end can be implanted in a coronary sinus or coronary vein;

an inflatable member disposed on the outer surface of the body between the proximal and distal ends, the inflatable member adapted to assume a deflated state and an inflated state in which the inflatable member is adapted to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end therein;

a conductive member extending from at least the proximal end toward the distal end of the body;

a generally tubular, flexible sheath made of an electrically insulative material disposed between the conductive member and the inner surface of the body, wherein separation between the sheath and the inner surface of the body defines an inflation lumen in fluid communication with the inflatable member; and

an electrode on the body electrically coupled to the conductive member.

15. The lead of claim 14 and further comprising at least one spacer member disposed between the sheath and the inner surface of the lead body, the spacer member adapted to maintain the separation between the sheath and the inner surface of the body.

16. The lead of claim 14 and further comprising a portal extending through the body proximate the proximal end, the portal adapted to facilitate introduction of a fluid into the inflation lumen.

17. The lead of claim 16 and further comprising a sealing feature coupled to the portal to substantially prevent loss of fluid through the portal.

18. The lead of claim 17 and further comprising an orifice extending through the lead body to fluidly couple the inflatable member and the inflation lumen.

19. A medical electrical lead comprising:

an elongate lead body having a proximal end, a distal end, an outer surface, and an inner surface, the body being made from an electrically insulative material and dimensioned such that the distal end can be implanted in a coronary sinus or coronary vein;

an inflatable member disposed on the outer surface of the body between the proximal and distal ends, the inflatable member adapted to assume a deflated state and an inflated state in which the inflatable member is adapted to impart a radial force on and frictionally engage a surface of the coronary sinus or coronary vein for fixation of the distal end therein;

a conductive member extending from at least the proximal end toward the distal end of the body;

an inner insulating layer disposed between the conductive member and the inner surface of the body and extending from the proximal end toward the distal end;

an inflation lumen between the inner insulating layer and the inner surface of the body in fluid communication with the inflatable member;

a portal extending through the body proximate the proximal end, the portal adapted to facilitate introduction of a fluid into the inflation lumen;

a sealing feature coupled to the portal to substantially prevent loss of fluid through the portal; and

an electrode on the body electrically coupled to the conductive member.