Granted Patent B2

US 12,403,306 · App. 16/167,079 · Granted Sep 2, 2025

Inventors: Brian L. Schmidt (White Bear Lake, MN); Jacob M. Ludwig (Isanti, MN); Benjamin J. Haasl (Forest Lake, MN); Michael J. Kane (St. Paul, MN)

Assignee: Cardiac Pacemakers, Inc.

A61N1/36002A61B18/14A61B18/18A61N1/0424A61N1/05A61N1/37247A61N5/02A61N1/36031A61N1/37229

Abstract

Claims (37)

1. A lead for a cancer treatment system comprising:

a lead body having a proximal end and a distal end, the lead body having a lumen with a cuff disposed at the distal end of the lead body, the lead body comprising

one or more conductors disposed within the lead body and providing electrical communication; and

an insulating material disposed circumferentially about and along the lead body over the one or more conductors;

wherein the lead body comprises one or more first zones and one or more second zones, wherein the insulating material disposed over the one or more conductors in the first zones is thicker than the insulating material disposed over the one or more conductors in the second zones;

wherein the second zones comprise at least a portion of the one or more conductors and at least a portion of the insulating material to form an electric field generating electrode configured to generate one or more therapeutic electric fields at or near a site of a cancerous tumor;

wherein the portion of the insulating material disposed about the one or more conductors in the second zones is configured to manipulate a strength of the one or more therapeutic electric fields generated by the electric field generating electrodes within the second zones;

the second zones having a stronger electric field than the first zones; and

wherein the cuff is reinforced with a shape set material such that the cuff is in a first elongate rectangular configuration prior to implantation and a second curled cylindrical configuration when implanted around the site of the cancerous tumor;

wherein the cuff comprises two or more cuff electrodes disposed on the cuff, wherein each of the two or more cuff electrodes is activated independently; and

wherein the cuff expands in diameter by at least 50% without structural failure.

2. The lead of claim 1 , further comprising an insulating flange disposed circumferentially on an exterior surface of the lead body, the insulating flange comprising an insulating material and configured to interrupt a direct electrical conduction path between a second zone and a different second zone, wherein the second zone and the different second zone function as electrodes.

3. The lead of claim 2 , wherein the direct electrical conduction path is a straight-line electrical conduction path.

4. The lead of claim 1 , wherein at a site of each second zone, the insulating material is disposed asymmetrically in thickness around a diameter of the lead body.

5. The lead of claim 1 , wherein the thickness of the insulating material over the one or more second zones is less than 10 μm.

6. The lead of claim 1 , wherein the thickness of the insulating material over the one or more first zones is less than 10 μm.

7. The lead of claim 1 , wherein the insulating material over the one or more first zones is different than the insulating material over the one or more second zones.

8. The lead of claim 1 , wherein the insulating material is selected from one or more of expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polyethylene-co-tetrafluoroethene (ETFE), polyurethane, silicone, poly (p-xylylene) polymer, polyether block amide, nylon, iridium oxide, titanium oxide, and tantalum pentoxide.

9. The lead of claim 1 , wherein the shape set material is nitinol.

10. The lead of claim 1 , wherein the lead is configured to implement a switching mechanism to change which of the one or more cuff electrodes are in electrical communication with the lead.

11. A method of treating a cancerous tumor comprising:

implanting a lead within a patient, the lead comprising

a lead body having a proximal end and a distal end, the lead body comprising

one or more conductors disposed within the lead body and providing electrical communication;

an insulating material disposed circumferentially about and along the lead body over the one or more conductors, wherein the lead body comprises one or more first zones and one or more second zones, and wherein the insulating material over the one or more conductors in the first zones is thicker than the insulating material disposed over the one or more conductors in the second zones, each second zone comprising at least a portion of the one or more conductors and at least a portion of the insulating material to form an electric field generating electrode configured to generate one or more therapeutic electric fields at or near the site of a cancerous tumor; and

a solid insulating flange disposed continuously circumferentially on an exterior surface of the lead body, wherein the solid insulating flange comprises a radial distance greater than its width, and wherein the solid insulating flange has a first segment having a first radial distance and a second segment having a second radial distance, such that the insulating flange is not radially symmetric in cross-section;

generating one or more therapeutic electric fields at or near the site of a cancerous tumor from the one or more electric field generating electrodes; and

wherein the portion of the insulating material disposed about the one or more conductors in the second zones is configured to manipulate a strength of the one or more therapeutic electric fields generated by the electric field generating electrodes within the second zones; and

the second zones having a stronger electric field than the first zones.

12. The method of claim 11 , wherein at least one second zone comprises a coiled electrode in electrical communication with at least one of the one or more conductors.

13. The method of claim 12 , wherein the coiled electrode is implanted subcutaneously.

14. The method of claim 11 , wherein at a site of each second zone, the insulating material is disposed asymmetrically in thickness around a diameter of the lead body.

15. The method of claim 14 , the one or more therapeutic electric fields comprising applied electric field strengths selected from a range of between 1 V/cm to 10 V/cm.

16. The method of claim 11 , the one or more therapeutic electric fields delivered at one or more frequencies selected from a range of between 100 kHz to 300 kHz.

17. The method of claim 11 , wherein the one or more therapeutic electric fields are generated using currents ranging from 20 mAmp to 500 mAmp.

18. The method of claim 11 , wherein the therapeutic electric field is delivered to a site of a cancerous tumor along more than one vector.

19. The method of claim 18 , wherein the therapeutic electric field is delivered to a site of a cancerous tumor along at least two vectors, wherein the vectors are disposed at an angle with respect to one another of at least 10 degrees.

Assignments (1)

Continuity (2)

References Cited (400)

Cited By (1)

US 12,649,056