Subcutaneous lead fixation mechanisms

• US 20070203556A1
• Filed: 02/28/2006
• Published: 08/30/2007
• Est. Priority Date: 02/28/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rutten, Jean, Smits, Karel, Kretzers, Leonardus
• Granted Patent: US 8,160,722 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• 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 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/3968 Constructional arrangements, e.g. casings A61N1/375 takes precedence

Abstract

A medical device that includes a lead having a lead body extending from a proximal end to a distal end, and a housing having a connector block for receiving the proximal end of the lead body. A fixation mechanism is positioned proximal to an electrode coil located at the distal end of the lead body, and a fixation member or a plurality of fixation members extend from the fixation mechanism from a fixation member proximal end to a fixation member distal end. The fixation members are advanceable from a first position corresponding to the fixation member distal end being positioned along the lead during subcutaneous placement of the lead, to a second position corresponding to the fixation member distal end being positioned away from the lead to fixedly engage the lead at a target site.

Claims

8. A medical device system including an electrode to be subcutaneously placed at a target site in a patient, comprising:

a lead having a lead body extending from a proximal end to a distal end, the electrode being positioned along the lead;

a fixation mechanism positioned along the lead body proximal to the electrode, the fixation mechanism extending from a proximal end having a first diameter approximately equal to a diameter of the lead and a distal end having a second diameter greater than the first diameter; and

a plurality of fixation members extending from the fixation mechanism forming a fixation member proximal end and a fixation member distal end, the plurality of fixation members being advanceable from a first position corresponding to the fixation mechanism distal end being positioned along the lead during subcutaneous placement of the electrode, to a second position corresponding to the fixation mechanism distal end being positioned away from the lead to fixedly engage the electrode at the target site.

1. A medical device system including an electrode to be subcutaneously placed at a target site in a patient, comprising:

a lead having a lead body extending from a proximal end to a distal end, the electrode being positioned along the lead;

a fixation mechanism positioned along the lead body proximal to the electrode; and

a plurality of fixation members extending from the fixation mechanism forming a fixation member proximal end and a fixation member distal end, the plurality of fixation members being advanceable from a first position corresponding to the fixation mechanism distal end being positioned along the lead during subcutaneous placement of the electrode, to a second position corresponding to the fixation mechanism distal end being positioned away from the lead to fixedly engage the electrode at the target site.

2. The medical device system of claim 1, further comprising a plurality of channels formed along the lead to receive the plurality of fixation members in the first position.

3. The medical device system of claim 1, further comprising a sheath capable of being positioned over the plurality of fixation members in the first position and being removable from the fixation tip in the second position.

4. The medical device system of claim 1, further comprising a sheath for receiving the lead, wherein the sheath includes a cutout portion extending the length of the sheath for receiving the plurality of fixation members as the lead is advanced through the sheath.

5. The medical device system of claim 4, further comprising an introducer for receiving the sheath, wherein the sheath extends to a distal end and has a diameter less than a diameter of a proximal end of the electrode, the distal end of the sheath engaged against the proximal end of the electrode, when the lead is positioned within the sheath, to advance the lead within the introducer.

6. The medical device system of claim 4, wherein the fixation member distal end ends outward from the sheath via the cutout portion.

7. The medical device system of claim 1, wherein the electrode is positioned at a distal end of the lead and the plurality of fixation members extend away from the electrode when the plurality of fixation members are in the first and the second position and extend toward the electrode when the plurality of fixation members are in a third position during extraction of the lead.

9. The medical device system of claim 1, further comprising a housing having a connector block for receiving the proximal end of the lead body.

10. The medical device system of claim 9, further comprising an introducer for receiving the sheath, wherein the sheath extends to a distal end and has a diameter less than a diameter of a proximal end of the electrode, the distal end of the sheath engaged against the proximal end of the electrode, when the lead is positioned within the sheath, to advance the lead within the introducer.

11. The medical device system of claim 10, wherein the fixation member distal end ends outward from the sheath via the cutout portion.

12. The medical device system of claim 11, wherein the electrode is positioned at a distal end of the lead and the plurality of fixation members extend away from the electrode when the plurality of fixation members are in the first and the second position and extend toward the electrode when the plurality of fixation members are in a third position during extraction of the lead.

13. The medical device system of claim 12, further comprising a housing having a connector block for receiving the proximal end of the lead body.

9-1. The medical device system of claim 8, further comprising a sheath for receiving the lead, wherein the sheath includes a cutout portion extending the length of the sheath for receiving the plurality of fixation members as the lead is advanced through the sheath.

14. A method of subcutaneously positioning a lead of a medical device system to a target site in a patient, the lead having an electrode located along a distal end of the lead and a fixation mechanism positioned along the lead body proximal to the electrode, comprising:

advancing a distal end of a first elongated member to the target site;

inserting the lead within the first elongated member, the inserting advancing a plurality of fixation members each having a fixation member proximal end and a fixation member distal end and extending from the fixation mechanism from a first position corresponding to the fixation mechanism distal end being positioned away from the lead, to a second position corresponding to the fixation mechanism distal end being positioned along the lead during subcutaneous placement of the electrode; and

extending the electrode and the fixation mechanism outward from the distal end of the first elongated member to advance the plurality of fixation members from second position to the first position to fixedly engage the electrode at the target site.

15. The method of claim 14, further comprising inserting the lead within a second elongated member prior to the inserting the lead into the first elongated member, the second elongated member having a cutout portion extending the length of the second elongated member for receiving the plurality of fixation members as the lead is advanced through the second elongated member.

16. The method of claim 15, wherein the second elongated member extends to a distal end and has a diameter less than a diameter of a proximal end of the electrode, the distal end of the second elongated member engaged against the proximal end of the electrode, when the lead is positioned within the second elongated member, to advance the lead within the first elongated member.

17. The method of claim 16, wherein the plurality of fixation members extend away from the electrode when the plurality of fixation members are in the first and the second position and extend toward the electrode when the plurality of fixation members are in a third position during extraction of the lead.