Apparatus and methods for vacuum- and mechanically-assisted fixation of medical electrical leads

• US 7,729,783 B2
• Filed: 04/26/2006
• Issued: 06/01/2010
• Est. Priority Date: 04/26/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lindemans, Fredric W., Jansens, Jean-Luc, Michels, Koen
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US11/380,228
• Publication Number:
  US 20070255375A1
• Time in Patent Office: 1,497 Days
• Field of Search: 607/116, 607/119, 607/122, 607/129, 607/130
• US Class Current: 607/130
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium

Abstract

A method and apparatus for providing positive fixation of medical components to a portion of pericardial tissue via both vacuum- and/or mechanically-assisted means. A source of vacuum couples via a lumen to a recessed portion of a body structure deployed into the pericardial space. The recessed portion is adapted to form a seal around its periphery with adjacent pericardial tissue so that when the recessed portion is evacuated, the tissue is drawn into the recessed portion. Then, a sharpened instrument, such as a stylet, is deployed through the lumen and pierces the tissue, thus anchoring the body structure. A source of fluid may also be included for delivery to the pericardial space (e.g., contrast media; saline solution; biological, genetic and pharmaceutical substances and the like).

Claims

1. An apparatus for securing an implantable medical device (IMD) within the pericardial space via vacuum-and/or mechanically-assisted techniques, comprising:

a body structure comprised of biocompatible material, said body structure having an epicardium-contacting side and an opposing pericardial sac-contacting side, wherein said body structure includes a recessed portion on the pericardial sac-contacting side;

an elongated medical electrical lead mechanically and electrically coupled to said body structure and fluidly coupled to the recessed portion, wherein the fluid coupling results from a lumen extending from a proximal end portion of the lead to said recessed portion;

an electrode mounted on the epicardium contacting side of the body structure;

a vacuum source coupled to the lumen and configured to evacuate the recessed portion; and

a deployable stylet disposed within the lumen and configured to pierce a portion of pericardial tissue when the vacuum source evacuates the recessed portion.

2. An apparatus according to claim 1, wherein the electrode comprises a cardiac pacing electrode.

3. An apparatus according to claim 1, further comprising a valve operatively coupled to the lumen and adapted to control the amount of suction provided by the vacuum source.

4. An apparatus according to claim 1, further comprising a radio-opaque marker coupled to the deployable stylet.

5. An apparatus according to claim 4, wherein the radio-opaque marker is disposed near a distal end of the deployable stylet.

6. An apparatus according to claim 4, wherein the deployable stylet includes a longitudinal lumen.

7. An apparatus according to claim 6, further comprising a source of fluid coupled to the lumen of the deployable stylet.

8. An apparatus according to claim 7, wherein the source of fluid comprises one of:

a source of contrast media, a source of saline solution, a source of biological material, a source of genetic material, a source of pharmaceutical material.

9. An apparatus according to claim 1, wherein the body structure is comprised of medical grade polyurethane.

10. An apparatus according to claim 9, wherein the recessed portion comprises a substantially hemispherical portion.

11. An apparatus according to claim 10, wherein the body structure comprises a substantially dome-shaped structure.

12. An apparatus according to claim 11, wherein an outer curved portion of the dome-shaped structure is configured to contact epicardial tissue and the recessed portion is disposed on the side opposing the outer curved portion.