Method of replacing an implanted neuromodulation device

Patent metadata

Field	Value
Publication number	US-11679256-B2
Application number	US-202016948856-A
Country	US
Kind code	B2
Filing date	Oct 2, 2020
Priority date	Oct 4, 2019
Publication date	Jun 20, 2023
Grant date	Jun 20, 2023

Abstract

A method of replacing a neurostimulator device. The method including explanting a previously implanted neurostimulator device from a site; operably coupling a replacement neurostimulator device to a previously implanted stimulation lead; and implanting a replacement neurostimulator device within the site, the replacement neurostimulator device having a volume of about ten cc's or less, and the previously implanted neurostimulator device having a volume of greater than about ten cc's.

First claim

What is claimed is:

1. A method of replacing a previously implanted neurostimulator device, the method comprising:
explanting the previously implanted neurostimulator device from a site within a patient;
operably coupling a first end of an adaptor to a replacement neurostimulator device, wherein the replacement neurostimulator device comprises a first plurality of electrical conductors spaced longitudinally apart at a first pitch spacing;
operably coupling a second end of the adaptor to a proximal portion of a previously implanted stimulation lead, wherein the proximal portion of the previously implanted stimulation lead comprises a second plurality of electrical conductors spaced longitudinally apart by a second pitch spacing different from the first pitch spacing; and
implanting the replacement neurostimulator device within the site.

2. The method of claim 1 , wherein the replacement neurostimulator device has a volume of about ten cubic centimeters or less.

3. The method of claim 1 , wherein the previously implanted neurostimulator device includes a non-rechargeable battery, and the replacement neurostimulator device includes a rechargeable battery.

4. The method of claim 1 , wherein the replacement neurostimulator device is adapted to address at least one of an overactive bladder (OAB) or incontinence.

5. The method of claim 1 , further comprising retracting a proximal portion of the previously implanted stimulation lead from the previously implanted neurostimulator device.

6. The method of claim 1 , wherein the adaptor is configured to couple between the previously implanted stimulation lead having electrical conductors spaced apart by at least one of a pitch spacing of about 0.085 inches or a pitch spacing of about 2 mm, and the replacement neurostimulator device having electrical conductors spaced apart at a pitch spacing of about 0.170 inches.

7. The method of claim 1 , wherein the adaptor is configured to couple between the previously implanted stimulation lead having electrical conductors spaced apart at a pitch spacing of about 0.170 inches, and the replacement neurostimulator device having electrical conductors spaced apart by at least one of a pitch spacing of about 0.085 inches or a pitch spacing of about 2 mm.

8. The method of claim 1 , wherein operably coupling the adaptor to the proximal portion of the previously implanted stimulation lead comprises engaging a set screw against the proximal portion of the previously implanted stimulation lead while the implanted stimulation lead is engaged within the adaptor.

9. The method of claim 1 , further comprising determining a viability of the previously implanted stimulation lead prior to operably coupling the adaptor to the proximal portion of the previously implanted stimulation lead.

10. The method of claim 1 , wherein a proximal portion of the adaptor comprises a flexible boot.

11. The method of claim 1 , further comprising determining, based on the second pitch spacing, that the previously implanted stimulation lead is not electrically compatible with the replacement neurostimulator device.

12. A method of replacing a previously implanted neurostimulator device, the method comprising:
explanting the previously implanted neurostimulator device from a site within a patient;
retracting a proximal portion of an implanted stimulation lead from the previously implanted neurostimulator device, wherein the proximal portion of the implanted stimulation lead comprises a first plurality of electrical conductors spaced longitudinally apart by a first pitch spacing;
determining, based on the first pitch spacing, that the implanted stimulation lead is not electrically compatible with a replacement neurostimulator device comprising a second plurality of electrical conductors spaced longitudinally apart by a second pitch spacing different from the first pitch spacing;
operably coupling the replacement neurostimulator device to an adaptor comprising an electrically compatible connection between the first pitch spacing and the second pitch spacing;
operably coupling the adaptor to the proximal portion of the implanted stimulation lead; and
implanting the replacement neurostimulator device within the site.

Assignees

• Medtronic Inc

Inventors

• Sandgren Robert T
• Formosa Elizabeth K
• Aman Kathryn E
• Deininger Steven
• Eichstaedt Paul
• Roles Randy S

Classifications

• A61N1/36125

  Details of circuitry or electric components · CPC title

• A61N1/3752

  Details of casing-lead connections · CPC title

• A61N1/36007 Primary

  of urogenital or gastrointestinal organs, e.g. for incontinence control · CPC title

• A61N1/3606

  adapted for a particular treatment · CPC title

• A61N1/0551 Primary

  Spinal or peripheral nerve electrodes · CPC title