Epicardial defibrilation lead with side helix fixation and placement thereof

• US 10,195,421 B2
• Filed: 08/11/2016
• Issued: 02/05/2019
• Est. Priority Date: 08/12/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Marshall, Mark T., Asleson, Andrea J., Rutten, Jean
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/234,481
• Publication Number:
  US 20170043155A1
• Time in Patent Office: 908 Days
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/0592 Introducing the lead through the pericardium with a needle
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A method and system for employing a medical device is disclosed. The medical device includes a housing, a processor disposed within the housing, a connector module, and a medical electrical epicardial lead connected to the processor through the connector module. The epicardial lead is used to sense a cardiac signal from tissue of a patient. The lead comprises an insulative lead body that includes a proximal end and a distal end, at least one conductor disposed in the lead body, and a side helical fixation member, disposed a distance from the distal end, the side helical fixation member. The side helical fixation member comprises a set of windings configured to wrap around the lead body circumference. The side helical fixation member includes a distal tip comprising a sharpened elongated flat free end that is perpendicular to the lead body and angled toward an inside of the set of windings.

Claims

1. A medical device comprising:

an implantable medical electrical epicardial lead that comprises;

(a) an insulative lead body that includes a proximal end and a distal end;

(b) at least one conductor disposed in the lead body; and

(c) a side helical fixation member, disposed a distance from the distal end, the side helical fixation member comprising a set of windings extending around a centerline and configured to wrap around the lead body circumference, the side helical fixation member including a distal tip comprising a sharpened elongated free end and comprising a final one of the windings defining an angle of 15 degrees or less with regard to a line perpendicular to the centerline.

2. The medical device of claim 1 wherein a diameter change is associated with the final one of the windings to create a wedging effect on tissue that causes the distal tip to solely remain in epicardial tissue.

3. The medical device of claim 2 wherein the diameter change associated with the final one of the windings ranges from 1.5 mm to 2.5 mm.

4. The medical device of claim 1 wherein the final one of the windings extends greater than 350 degrees around a circumference of the side helical fixation member.

5. The medical device of claim 1 wherein a clear polymer is introduced over the open portion of the side helical fixation member, the clear polymer configured to allow a physician to visualize turning of the side helical fixation member into tissue.

6. The medical device of claim 1 wherein a polymer is introduced over the open portion of the side helical fixation member and over a portion of the set of windings to secure the side helical fixation member to the lead body.

7. The medical device of claim 1 wherein the distal tip of the side helical fixation member is configured to perform a minimum of at least ¾

turn in tissue.

8. The medical device of claim 1 wherein the side helical fixation member disposed at a distance of 3 cm to 12 cm from the distal end.

9. The medical device of claim 1 wherein the side helical fixation mechanism has a first wind that extends a small distance D2 to the second wind.

10. The medical device of claim 9 wherein a steep angle exists into the first wind of the helical fixation mechanism.

11. The medical device of claim 10 wherein a shallow angle into tip exists in the side helical fixation mechanism.

12. A system for employing a medical device having a housing, a processor disposed within the housing, and a medical electrical epicardial lead connected to the processor through a connector module, the system comprising:

processor means for using the epicardial lead to sense a response from cardiac tissue, the lead comprising;

(a) an insulative lead body that includes a proximal end and a distal end;

(b) at least one conductor disposed in the lead body; and

(c) a side helical fixation member, disposed a distance from the distal end, the side helical fixation member comprising a set of windings extending around a centerline and configured to wrap around a lead body circumference, the side helical fixation member including a distal tip comprising a sharpened free end and comprising a final one of the windings defining an angle of 15 degrees or less with regard to a line perpendicular to the centerline; and

the system further comprising means for delivering electrical pulses through the lead to tissue of a patient in response to sensing the response.