Kit for penetrating the cardiac septum and for implantation of a transeptal lead, including a lead for detection/stimulation of a left heart cavity

Patent metadata

Field	Value
Publication number	US-10065032-B2
Application number	US-201414557060-A
Country	US
Kind code	B2
Filing date	Dec 1, 2014
Priority date	Nov 30, 2009
Publication date	Sep 4, 2018
Grant date	Sep 4, 2018

Abstract

A method of implanting a lead in the left heart cavity includes introducing the lead into the right heart cavity. The lead includes a lead body having a deformable sheath, a proximal end having an electrical connector, a distal end including a projecting helical screw electrode, and a conductor extending along the sheath, electrically connecting the electrical connector and the helical screw. The method further includes positioning the distal end of the lead to abut a septum wall between the right and left heart cavity. The electrical connector is connected to an RF puncture generator and RF energy is applied to the screw while providing rotational movement to the screw for advancement through the septum wall. The method further includes positioning the screw at a target stimulation site in the left heart cavity and providing rotational movement to the screw to anchor the lead at the target site.

First claim

What is claimed is:

1. A method of implanting a detection/stimulation lead in the left heart cavity, comprising:
introducing a detection/stimulation lead into the right heart cavity, the lead comprising:
a lead body comprising a sheath of a deformable material;
a proximal end having an electrical connector;
a distal end having a lead head including an electrode comprising a projecting helical screw; and
a conductor extending along the sheath, electrically connecting said electrical connector and the projecting helical screw;

positioning the distal end of the lead to abut a septum wall between the right heart cavity and the left heart cavity;
connecting the electrical connector to an RF puncture generator and applying RF energy to the projecting anchoring screw;
providing rotational movement to the projecting helical screw while the RF energy is being applied to advance the projecting helical screw through the septum wall;
positioning the projecting helical screw at a target stimulation site in the left heart cavity;
providing rotational movement to the projecting helical screw to anchor the lead at the target stimulation site for stimulation/detection;
disconnecting the electrical connector from the RF puncture generator; and
connecting the electrical connector to an implantable medical device to provide stimulation energy to tissue at the target stimulation site,
wherein the helical anchoring screw comprises a conductive part and an electrically isolated part, wherein the electrically isolated part is distal of and extends from said conductive part, the electrically isolated part performing a traction function for penetrating the septum wall in response to the rotational motion applied to the helical anchoring screw, and the conductive part performing a septum wall cutting function for delivering the RF energy to the septum wall concurrently with the rotational motion applied to the helical anchoring screw.

2. The method of claim 1 , further comprising, prior to applying RF energy to the projecting helical screw, providing rotational movement to the projecting helical screw to cause penetration of the septum wall by the projecting helical screw.

3. The method of claim 1 , wherein the projecting helical screw comprises a moveable screw, and wherein providing rotational movement to the projecting helical screw moves the projecting helical screw from a retracted position inside the lead body to an extended position outside of the lead body.

4. The method of claim 1 , further comprising providing an axial force to the lead body in the direction of advancement of the helical anchoring screw to assist with advancement of the helical anchoring screw through the septum wall.

5. The method of claim 1 , further comprising:
performing a pre-puncture of the septal wall with an RF guidewire prior to advancing the detection/stimulation lead through the septal wall; and
testing the pre-puncture site to confirm the site is suitable for puncture and transeptal passage of the detection/stimulation lead.

6. The method of claim 5 , wherein the lead is introduced over the guidewire to the pre-puncture site where the projecting helical screw is positioned to puncture the septum wall.

7. The method of claim 5 , wherein the guidewire is introduced through the stimulation lead anchored in the septum wall.

8. The method of claim 1 , wherein the sheath has an insufficient torsional rigidity to transmit over its entire length a rotation movement imparted at the proximal end of the lead.

9. The method of claim 8 , further comprising inserting a removable stylet into of the lead body to further drive the advancement of the projecting helical screw through the septum wall.

10. The method of claim 9 , wherein the stylet is configured to have a sufficient torsional rigidity to transmit over its entire length a rotating movement imparted at a proximal end of the stylet, for rotating the projecting helical screw.

11. The method of claim 1 , wherein the helical screw has a diameter of 1.0 mm to 1.2 mm.

12. A system for providing stimulation in the left heart cavity with a transeptal lead, comprising:
a detection/stimulation lead, comprising:
a lead body;
a proximal end having an electrical connector;
a distal end having a lead head including an electrode comprising a projecting helical screw;
and a conductor extending along the sheath, electrically connecting said electrical connector and the projecting helical screw; and

a radio-frequency puncture generator having an output to connect to the lead electrical connector for providing radio-frequency energy for puncturing a septum wall;
wherein the lead electrical connector is configured to connect to an implantable medical device for providing stimulation energy to a stimulation site in cardiac tissue when the lead has passed through the septum wall; wherein the projecting helical screw comprises an active portion for providing RF energy for puncturing the cardiac septum when the electrical connector is connected to the radio-frequency puncture generator, and for providing stimulation energy for stimulation of cardiac tissue when the electrical connector is connected to the implantable medical device, and
wherein said projecting helical screw comprises a conductive part and an electrically isolated part, wherein the electrically isolated part is distal of and extends from said conductive part, the electrically isolated part having a traction function for penetrating the septum wall in response to a screw motion applied to the lead head, and the conductive part having a septum wall cutting function for delivering the radio-frequency energy to the septum wall concurrently with a screw motion applied to the lead head.

13. The system of claim 12 , wherein the helical screw is further configured to anchor the lead at the stimulation site in the cardiac tissue.

14. The system of claim 12 , wherein the electrode comprising the projecting helical screw is a stimulation and detection electrode.

15. The system of claim 12 , wherein the projecting helical screw is a moveable screw having a retracted position in the lead body and an extended position outside of the lead body.

16. The system of claim 12 , further comprising:
a removable stylet, inserted into a lumen of the lead body and movable in translation within that lumen to the lead head;
a coupling mechanism for coupling the stylet in rotation with the lead head,
wherein the stylet is configured having a sufficient torsional rigidity to transmit over its entire length a rotating movement imparted at a proximal end of the stylet, for rotating the projecting helical screw.

17. The system of claim 12 , wherein the helical screw is further configured to anchor the lead such that the lead passing the septum wall is anchored to make a transeptal implantation of the lead.

18. The system of claim 12 , wherein the anchoring screw is a fixed screw axially extending from the lead head.

19. The system of claim 12 , further comprising a RF guidewire having a proximal end and a conductive distal end, wherein, in response to the distal end being positioned at a pre-puncture site of the septum wall and the proximal end being connected to the controlled radio-frequency energy output of the RF puncture generator, the conductive distal end delivers the controlled radio frequency energy to pre-puncture the septum wall, and wherein the lead further comprises a carrier lead mounted on the guidewire.

20. The system of claim 12 , wherein the helical scr

Assignees

• Sorin Crm Sas

Inventors

• Ollivier Jean-François

Classifications

• A61N1/0573 Primary

  chacterised by means penetrating the heart tissue, e.g. helix needle or hook · CPC title

• A61B2018/00273

  Anchoring means for temporary attachment of a device to tissue · CPC title

• A61B2018/00642

  with feedback, i.e. closed loop control · CPC title

• A61B18/1206

  Generators therefor · CPC title

• A61B2018/00351

  Heart · CPC title