Detection/stimulation implantable microlead incorporating an anti-inflammatory agent

• US 9,827,354 B2
• Filed: 06/09/2014
• Issued: 11/28/2017
• Est. Priority Date: 06/11/2013
• Status: Active Grant

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Inventors: D'Hiver, Philippe
• Primary Examiner(s): Medway, Scott
• Application Number:
  US14/299,243
• Publication Number:
  US 20140364793A1
• Time in Patent Office: 1,268 Days
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• 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 1/0568 with drug delivery
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A microlead includes a conductive cable formed by a strand of microcables, each microcable being formed of a strand of individual metallic wires. The microlead also includes an insulation layer sheathing the cable. The microlead further includes at least one exposed area formed in the insulation layer so as to form a corresponding electrode of the microlead. The microlead further includes a pharmacologically active agent (e.g., an anti-inflammatory agent) configured to gradually be released into the environment of the microlead after implantation of the microlead. The pharmacologically active agent may be a soluble material. An interstitial space, delimited by the inner wall of the insulation layer and existing in the remainder between the wires of each microcable, is filled with the pharmacologically active agent.

Claims

1. A detection/stimulation microlead for implantation in venous, arterial or lymphatic networks and having an active distal portion devoid of a central lumen, the microlead comprising:

an electrically conductive cable formed by a strand of microcables, each microcable being formed of a strand of individual metallic wires;

an insulation layer of an electrically insulating material, sheathing the cable;

a plurality of exposed areas formed in the insulation layer so as to form corresponding electrodes of the microlead;

an interstitial space defined between the microcables and an internal wall of the insulation layer between the plurality of exposed areas; and

a pharmacologically active agent present in the interstitial space and configured to gradually diffuse from the interstitial space into the plurality of exposed areas and into an environment of the microlead after implantation thereof.

2. The microlead of claim 1, wherein the pharmacologically active agent is soluble.

3. The microlead of claim 2, wherein the pharmacologically active agent is an anti-inflammatory agent.

4. The microlead of claim 3 wherein the anti-inflammatory agent is a glucocorticoid provided by dexamethasone sodium phosphate.

5. The microlead of claim 2, wherein the anti-inflammatory agent is a non-steroidal anti-inflammatory agent.

6. The microlead of claim 1, wherein a distal end of the microlead comprises an extension of the insulation layer beyond a termination of said cable, said extension defining a cavity forming an additional reservoir for the pharmacologically active agent, the reservoir being closed at its distal end by an atraumatic element.

7. The microlead of claim 1, wherein a diameter of the distal end of the microlead is less than 0.5 mm.

8. The microlead of claim 1, wherein the insulation layer comprises an ethylene tetrafluoroethylene layer.

9. The microlead of claim 1, wherein the insulation layer has a thickness of 25 μ

m.

10. The microlead of claim 1, wherein the interstitial space is approximately 50% of a volume delimited by the internal wall of the insulation layer.

18. The microlead of claim 1, wherein the interstitial space is also defined between the wires of each microcable, and wherein the pharmacologically active agent is also present in the interstitial space defined between the wires of each microcable.

19. The microlead of claim 1, wherein the pharmacologically active agent present in the interstitial space is introduced to the interstitial space by evacuating air of the interstitial space and causing the pharmacologically active agent to replace a void formed by the evacuation of the air of the interstitial space.

11. A method for providing a pharmacologically active agent to a stimulation area in a venous, arterial, or lymphatic network, the method comprising:

providing a microlead, the microlead comprising;

an active distal portion formed by an electrically conductive cable formed by a strand of microcables, each microcable formed of a strand of individual metallic wires;

an insulation layer of an electrically insulating material sheathing the cable;

a plurality of exposed areas formed in the insulation layer so as to form corresponding electrodes of the microlead; and

an interstitial space defined between the microcables and an internal wall of the insulation layer between the plurality of exposed areas;

introducing a pharmacologically active agent to the interstitial space;

implanting the microlead in the venous, arterial, or lymphatic network; and

allowing the pharmacologically active agent to gradually diffuse from the interstitial space into the plurality of exposed areas and into tissue surrounding the at least one exposed area at the stimulation area.

12. The method of claim 11, wherein the pharmacologically active agent is an anti-inflammatory agent.

13. The method of claim 12, wherein the anti-inflammatory agent is a glucocorticoid.

14. The method of claim 13, wherein the glucocorticoid is dexamethasone sodium phosphate.

15. The method of claim 12, wherein the anti-inflammatory agent is a non-steroidal anti-inflammatory agent.

16. The method of claim 12, wherein the introducing comprises:

introducing the pharmacologically active agent in an aqueous solution into the interstitial space; and

allowing the solution to dry so as to allow recrystallization of the pharmacologically active agent into a solid form.

17. The method of claim 16, wherein allowing the pharmacologically active agent to gradually diffuse comprises:

allowing the pharmacologically active agent to rehydrate by the plurality of exposed areas once the microlead is implanted; and

allowing the pharmacologically active agent to form a concentration gradient between blood circulating around the microlead and an internal environment of the microlead.

20. The method of claim 11, wherein the introducing comprises:

evacuating air of the interstitial space; and

causing the pharmacologically active agent to replace a void formed by the evacuation of the air of the interstitial space.