Medical electrical lead having an anchoring sleeve retaining device

• US 5,683,446 A
• Filed: 05/25/1995
• Issued: 11/04/1997
• Est. Priority Date: 05/25/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gates, James T.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/450,761
• Time in Patent Office: 894 Days
• Field of Search: 607/126, 607/122, 607/123, 607/127, 607/128, 607/116, 607/149, 128/639, 128/642
• US Class Current: 607/126
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

The present invention is a transvenous lead having an anchoring sleeve retaining device. The transvenous lead features a lead covered by an insulative sleeve. Positioned at the distal end of the lead is an electrode assembly. Also positioned proximate the electrode assembly is a fixation mechanism. At the proximal end of the lead body is a terminal assembly. The terminal assembly permits the lead to be connected to a pulse generator. The anchoring sleeve retaining device further features a removable portion that frictionally engages the lead and prevents the anchoring sleeve from sliding along the lead prior to suturing the anchoring sleeve to the lead.

Claims

1. A body implantable lead, comprising:

a conductor having a proximal end and a distal end;

an insulating sleeve having an outer diameter, the insulating sleeve covering the conductor between the proximal end and the distal end;

an electrode coupled to the distal end of the conductor;

an electrical connector coupled to the proximal end of the conductor;

an anchoring sleeve positioned about the insulating sleeve and between the connector and the electrode, the anchoring sleeve having proximal and distal ends, the anchoring sleeve having a first lumen for accepting the conductor an insulting sleeve therewithin, the first lumen having an imaginary axis extending and centered axially therethrough, the first lumen having a first portion having a first diameter greater than the outer diameter of the insulating sleeve and a second portion having a second diameter less than the outer diameter of the insulating sleeve, the second portion being disposed at the proximal end of the anchoring sleeve and forming a manually tearable, thinned segment; and

an anchoring sleeve retaining device having distal and proximal ends and a second lumen for accepting the conductor and insulating sleeve therewithin, the second lumen being disposed at least partially within a retaining device body and being aligned axially in respect of the first lumen and the imaginary axis, the retaining device having substantially parallel proximal and distal surfaces that project outwardly away from the central axis and the retaining device body, the surfaces terminating in a common outer edge, the distal end of the retaining device being attached by the thinned segment to the proximal end of the anchoring sleeve, a manually tearable scored tear line extending between the distal and proximal surfaces and from the outer edge to a location propinquant to the thinned segment.

2. A body implantable lead according to claim 1, wherein the first and second portions are constructed of silicone.

3. A body implantable lead according to claim 1, wherein the electrode comprises a tine fixation assembly.

4. A body implantable lead according to claim 1, wherein the lead is isodiametric.

5. A body implantable lead according to claim 1, wherein the anchoring sleeve further having at least one slot disposed therein, the slot extending between the first lumen and the outer surface of the anchoring sleeve.

6. A body implantable lead according to claim 1, wherein the anchoring sleeve further includes at least one suturing groove formed on the outer surface thereof.

7. A body implantable lead, comprising:

a conductor having a proximal end and a distal end;

an insulating sleeve having an outer diameter, the insulating sleeve covering the conductor between the proximal end and the distal end;

an electrode coupled to the distal end of the conductor;

an electrical connector coupled to the proximal end of the conductor;

an anchoring sleeve positioned about the insulating sleeve and between the connector and the electrode, the anchoring sleeve having proximal and distal ends, the anchoring sleeve having a first lumen for accepting the conductor and sleeve therewithin, the first lumen having a first portion having a first diameter greater than the outer diameter of the insulating sleeve and a second portion having a second diameter less than the outer diameter of the insulating sleeve, the second portion being disposed at the proximal end of the anchoring sleeve and forming a manually tearable, thinned segment; and

means for manually removing, at the location of the thinned segment, the second portion from the first portion, the removing means having distal and proximal ends and a second lumen for accepting the conductor and insulating sleeve therewithin, the distal end of the removing means being attached by the thinned segment to the proximal end of the anchoring sleeve.

8. An anchoring sleeve suitable for use in conjunction with a body implantable lead, where the lead has at least one inner conductor covered by an outer insulative sleeve, the anchoring sleeve accepting and gripping the lead therein, comprising:

a proximal end;

a distal end;

a first lumen for accepting the conductor and insulating sleeve therewithin, the first lumen having an imaginary axis extending and centered axially therethrough, the first lumen having a first portion having a first diameter greater than the outer diameter of the insulating sleeve and a second portion having a second diameter less than the outer diameter of the insulating sleeve, the second portion being disposed at the proximal end of the anchoring sleeve and forming a manually tearable, thinned segment; and

an anchoring sleeve retaining device having distal and proximal ends and a second lumen for accepting the conductor and insulating sleeve therewithin, the second lumen being disposed at least partially within a retaining device body and being aligned axially in respect of the first lumen and the imaginary axis, the retaining device having substantially parallel proximal and distal surfaces that project outwardly away from the central axis and the retaining device body, the surfaces terminating in a common outer edge, the distal end of the retaining device being attached by the thinned segment to the proximal end of the anchoring sleeve, a manually tearable scored tear line extending between the distal and proximal surfaces and from the outer edge to a location propinquant to the thinned segment.

9. The anchoring sleeve of claim 8, wherein the anchoring sleeve is formed of silicone.

10. An anchoring sleeve according to claim 8, wherein the anchoring sleeve further includes at least one suturing groove formed on the outer surface thereof.

11. An anchoring sleeve according to claim 8, wherein the anchoring sleeve further has at least one slot disposed therein, the slot extending between the first lumen and the outer surface of the anchoring sleeve.