DETECTION/STIMULATION MICROLEAD IMPLANTABLE IN A VESSEL OF THE VENOUS, ARTERIAL OR LYMPHATIC NETWORK

• US 20150148645A1
• Filed: 11/26/2014
• Published: 05/28/2015
• Est. Priority Date: 11/27/2013
• Status: Active Grant

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Inventors: Rgnier, Willy, d'Hiver, Philippe
• Granted Patent: US 9,730,595 B2
• Time in Patent Office: Days
• US Class Current: 600/381
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6876 Blood vessel
• 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 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

A microlead has a distal active portion formed by a microcable including an electrically conductive core coated with an insulation layer, with a plurality of exposed areas forming the stimulation electrodes. The microcable has a three-dimensional preshape inscribed in a cylindrical envelope volume so as to match the target vessel wall. The microcable includes a plurality of exposed areas regularly distributed over the circumference of the cylindrical envelope volume considered in axial projection, the exposed zones extending only over an angular sector of the microcable considered in cross section, said angular sector facing the outside of the envelope volume of the preshape.

Claims

1. A detection/stimulation microlead for implantation in a target vessel of the venous, arterial, or lymphatic network for stimulation of tissue in the region of the target vessel, the microlead comprising:

a distal active portion comprising a microcable of a diameter at most equal to 2 French (0.66 mm) comprising an electrically conductive core coated with an insulation layer;

wherein the microcable further comprises;

at least one stimulation area having a plurality of exposed areas formed in the insulation layer forming a plurality of stimulation electrodes, wherein the surface without insulating coating of each exposed area is between 0.1 mm² and 1 mm²; and

a three-dimensional preshape at the stimulation area configured so that the microcable contacts the wall of the target vessel in the stimulation area;

wherein the three-dimensional preshape is comprised in a cylindrical envelope volume whose diameter is selected to be in the free state of the microcable, greater than the diameter of the target vessel; and

wherein the plurality of exposed areas are disposed at respective locations of said microcable on said cylindrical envelope volume, these locations being uniformly distributed on the circumference of the cylindrical envelope volume considered in axial projection.

2. The microlead of claim 1, wherein the surface without insulating coating of each exposed area is less than or equal to 0.1 mm².

3. The microlead of claim 1, wherein:

each exposed area extends only over an angular sector of the cross-section of the microcable; and

the angular sector is oriented outward of the envelope volume of the preshape.

4. The microlead of claim 1, wherein the three-dimensional preshape is a helical preshape.

5. The microlead of claim 1, wherein the plurality of exposed areas are disposed at respective locations of the microcable regularly distributed in the longitudinal direction on the cylindrical envelope volume.

6. The microlead of claim 1, comprising two distinct stimulation areas separated by an intermediate region.

7. The microlead of claim 6, wherein the intermediate region comprises a retention and elongation area, elastically deformable in the longitudinal direction under the effect of tensile/compression axial stress exerted on the microlead in its proximal area with respect to the elongation area.

8. The microlead of claim 7, wherein the intermediate region comprises a preshape formed in the microcable in a free state.

9. The microlead of claim 8, wherein the preshape of the intermediate region is selected to have a diameter smaller than the diameter of the target vein.

10. The microlead of claim 6, wherein the two stimulation areas have an identical configuration.

11. The microlead of claim 1, wherein the conductive core comprises a single conductor and wherein the microlead is a monopolar stimulation lead.

12. The microlead of claim 1, wherein the conductive core comprises a plurality of conductors and wherein the microlead is a multipolar stimulation lead.

13. The microlead of claim 1, wherein cylindrical envelope volume has a diameter of at least twice the diameter of the target vessel.

14. The microlead of claim 1, further comprises three exposed areas forming three stimulation electrodes.

15. The microlead of claim 14, wherein the three exposed areas are uniformly distributed at 120 degrees apart on the circumference of the cylindrical envelope volume considered in axial projection.

16. A method of stimulating distinct areas of tissue via the venous coronary network, comprising:

introducing a microlead into the venous coronary network through the coronary sinus;

advancing the lead so as to position a first set of stimulation electrodes of the microlead in a first vessel, a second set of stimulation electrodes in a second vessel, and an intermediate region through an anastomosis providing passage from the first vessel to the second vessel;

wherein the microlead comprises an electrically conductive core coated with an insulation layer and a diameter no greater than 2 French (0.66 mm);

wherein the first set and the second set of stimulation electrodes are formed by exposed areas formed in the insulation layer;

wherein the first set and the second set of stimulation electrodes are separated by the intermediate region;

wherein each of the first set and the second set of stimulation electrodes forms a stimulation area, and wherein the stimulation area comprises a three-dimensional preshape configured so that the microlead contacts the wall of the target vessel in the stimulation area;

wherein the three-dimensional preshape is comprised in a cylindrical envelope volume with a diameter in the free state of the microcable, greater than the diameter of the target vessel;

wherein the stimulation electrodes in each stimulation area are disposed at respective locations of said microlead on said cylindrical envelope volume, these locations being uniformly distributed on the circumference of the cylindrical envelope volume in axial projection; and

providing stimulation through the target vessels by the first and second set of electrodes.

17. The method of claim 16, wherein the intermediate region of the microlead is elastically deformable in the longitudinal direction under the effect of tensile/compression axial stress exerted on the microlead in its proximal area with respect to the elongation area.

18. The method of claim 17, wherein the intermediate region of the microlead comprises a preshape formed in the microcable in a free state, wherein the preshape of the intermediate region of the microlead is selected to have a diameter smaller than the diameter of the target vein.

19. The method of claim 16, wherein the surface without insulating coating of each exposed area forming the stimulation electrodes is between 0.1 mm² and 1 mm².

20. A detection/stimulation microlead for implantation in a target vessel for stimulation of tissue in the region of the target vessel, the microlead comprising:

a three-dimensional helical preshape at a stimulation area, the stimulation area comprising a plurality of electrodes, and the three-dimensional helical preshape configured such that the microlead contacts the wall of the target vessel in the stimulation area;

wherein the three-dimensional helical preshape is comprised in a cylindrical envelope volume having a diameter, in the free state of the microlead, greater than the diameter of the target vessel; and

wherein the plurality of electrodes are disposed at respective locations of said microlead on said cylindrical envelope volume, these locations being uniformly distributed on the circumference of the cylindrical envelope volume considered in axial projection.