Miniature implantable neurostimulator system for sciatic nerves and their branches

• US 10,195,425 B2
• Filed: 01/25/2018
• Issued: 02/05/2019
• Est. Priority Date: 08/17/2014
• Status: Active Grant

• Current Assignee: Coloplast A/S
• Original Assignee: Nine Continents Medical, Inc. (Coloplast A/S)
• Inventors: Ostroff, Alan, Jacobson, Peter
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US15/880,373
• Publication Number:
  US 20180161576A1
• Time in Patent Office: 376 Days
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

This application describes a miniature implantable neurostimulator system for sciatic nerves and their branches. The implanted miniature neurostimulator is implanted in the leg and stimulates these nerves for the treatment of urinary or bowel incontinence. The miniature implantable neurostimulator has a low duty cycle permitting a small size with medically-acceptable longevity. The system includes a wireless programmer and patient-activated key fob.

Claims

1. An implantable device for permanent implantation in a body of a subject for long-term use to stimulate tissue, the device comprising:

an enclosure configured to be implanted in a body of a subject;

a battery disposed within the enclosure;

circuitry disposed within the enclosure and coupled to the battery, the circuitry being configured to generate a stimulation signal with a duty cycle of between 0.1% and 2.5% and a total average current drain from the battery of between 0.1 μ

A and 5 μ

A, the total average current drain comprising a background current, plus a stimulation current weighted by the duty cycle, wherein the battery provides power to the circuitry to generate the stimulation signal;

an electrode assembly coupled to the enclosure and the circuitry, the electrode assembly configured to direct the generated stimulation signal to the tissue of the subject; and

a lead coupling the electrode assembly to the enclosure and separating at least a portion of the electrode assembly from the enclosure,

wherein the background current, the stimulation signal current, and the duty cycle combine to provide a useful life of the implantable device implanted in the body of the subject of at least 5 years without removal from the body.

2. The implantable device of claim 1, wherein the useful life of the implantable device is in a range of between 5 and 35 years, 6 and 34 years, 7 and 33 years, 8 and 32 years, 9 and 31 years, 10 and 30 years, 11 and 29 years, 12 and 28 years, 13 and 27 years, 14 and 26 years, 15 and 25 years, 16 and 24 years, 17 and 23 years, 18 and 22 years, or 19 and 21 years.

3. The implantable device of claim 1, wherein the duty cycle of the stimulation signal is in a range of between 2.4% and 0.1%, 2.3% and 0.1%, 2.2% and 0.1%, 2.1% and 0.1%, 2.0% and 0.1%, 1.9% and 0.1%, 1.8% and 0.1%, 1.7% and 0.1%, 1.6% and 0.1%, 1.5% and 0.1%, 1.4% and 0.1%, 1.3% and 0.1%, 1.2% and 0.1%, 1.1% and 0.1%, 1.0% and 0.1%, 0.9% and 0.1%, 0.8% and 0.1%, 0.7% and 0.1%, 0.6% and 0.1%, 0.5% and 0.1%, 0.4% and 0.1%, 0.3% and 0.1%, or 0.2% and 0.1%.

4. The implantable device of claim 1, wherein the circuitry is configured to generate the stimulation signal for 30 minutes once a week.

5. The implantable device of claim 1, wherein the background current is in a range of between 4.5 μ

A and 0.10 μ

A, 4.0 μ

A and 0.10 μ

A, 3.5 μ

A and 0.10 μ

A, 3.0 μ

A and 0.10 μ

A, 2.5 μ

A and 0.10 μ

A, 2.0 μ

A and 0.10 μ

A, 1.5 μ

A and 0.10 μ

A, 1.0 μ

A and 0.10 μ

A, 0.9 μ

A and 0.10 μ

A, 0.8 μ

A and 0.10 μ

A, 0.7 μ

A and 0.10 μ

A, 0.6 μ

A and 0.10 μ

A, 0.5 μ

A and 0.10 μ

A, 0.4 μ

A and 0.10 μ

A, 0.3 μ

A and 0.10 μ

A, or 0.2 μ

A and 0.1 μ

A.

6. The implantable device of claim 1, wherein the generated stimulation signal has a stimulation pulse current in a range of between 19 mA and 1 mA, 18 mA and 2 mA, 17 mA and 3 mA, 16 mA and 4 mA, 15 mA and 5 mA, 14 mA and 6 mA, 13 mA and 7 mA, 12 mA and 8 mA, or 11 mA and 9 mA.

7. The implantable device of claim 1, wherein the generated stimulation signal has a stimulation frequency in a range between 30 Hz and 10 Hz, 29 Hz and 11 Hz, 28 Hz and 12 Hz, 27 Hz and 13 Hz, 26 Hz and 14 Hz, 25 Hz and 15 Hz, 24 Hz and 16 Hz, 23 Hz and 17 Hz, 22 Hz and 18 Hz, or 21 Hz and 19 Hz.

8. The implantable device of claim 1, wherein the generated stimulation signal has a stimulation pulse width in a range of between 300 μ

s and 100 μ

s, 290 μ

s and 110 μ

s, 280 μ

s and 120 μ

s, 270 μ

s and 130 μ

s, 260 μ

s and 140 μ

s, 250 μ

s and 150 μ

s, 240 μ

s and 160 μ

s, 230 μ

s and 170 μ

s, 220 μ

s and 180 μ

s, or 210 μ

s and 190 μ

s.

9. The implantable device of claim 1, wherein the battery has a capacity in a range between 360 mAH and 100mA, 350 mAH and 110 mAH, 340 mAH and 120 mAH, 330 mAH and 130 mAH, 320 mAH and 140 mAH, 310 mAH and 150 mAH, 300 mAH and 160 mAH, 290 mAH and 170 mAH, 280 mAH and 180 mAH, 270 mAH and 190 mAH, 260 mAH and 200 mAH, 250 mAH and 210mAH, or 240 mAH and 220 mAH.

10. The implantable device of claim 1, wherein a total volume of the implantable device is in a range between 1.9 cc and 0.1 cc, 1.8 cc and 0.2 cc, 1.7 cc and 0.3 cc, 1.6 cc and 0.4 cc, 1.5 cc and 0.5 cc, 1.4 cc and 0.6 cc, 1.3 cc and 0.7 cc, 1.2 cc and 0.8 cc, or 1.1 cc and 0.9 cc.

11. The implantable device of claim 1, wherein the electrode assembly is separated from the enclosure by the lead by a distance in a range between 15 cm and 0.1 mm, 14 cm and 0.1 mm, 13 cm and 0.1 mm, 12 cm and 0.1 mm, 11 cm and 0.1 mm, 10 cm and 0.1 mm, 9 cm and 0.1 mm, 8 cm and 0.1 mm, 7 cm and 0.1 mm, 6 cm and 0.1 mm, 5 cm and 0.1 mm, 4 cm and 0.1 mm, 3 cm and 0.1 mm, 2 cm and 0.1 mm, or 1 cm and 0.1 mm.

12. The implantable device of claim 1, wherein the battery comprises a primary battery.

13. The implantable device of claim 1, wherein the enclosure comprises a fixation element to anchor into the tissue, thereby reducing migration of the implantable device during long-term use in the subject.

14. The implantable device of claim 1, wherein at least a portion of the electrode assembly is configured for placement adjacent a nerve of the subject.

15. The implantable device of claim 1, wherein the electrode assembly comprises a fixation element, thereby reducing migration of the implantable device during long-term use in the subject.

16. The implantable device of claim 1, wherein the circuitry comprises a wireless communication transceiver configured to wirelessly communicate with an external programmer.

17. The implantable device of claim 16, wherein the wireless communication transceiver of the circuitry communicates with the external programmer through a conductive connection, and the wireless communication transceiver is configured to generate a communication signal received by the external programmer, the communication signal being one or more of below a threshold stimulation pulse amplitude, below a threshold stimulation pulse duration, or during a refractory period of a nerve.

18. The implantable device of claim 1, wherein the circuitry comprises a magnetic field sensor configured to detect a magnetic field.

19. The implantable device of claim 18, wherein the circuitry is configured to disable, postpone, or otherwise modify a therapeutic protocol of the implantable device in response to the detected magnetic field.

20. The implantable device of claim 18, where in the magnetic field sensor comprises a giant magnetoresistance (GMR) switch.

21. The implantable device of claim 1, wherein the generated stimulation signal is configured to treat one or more of urinary incontinence, bowel incontinence, acute pain, chronic pain, hypertension, congestive heart failure, gastro-esophageal reflux, obesity, erectile dysfunction, insomnia, a movement disorder, or a psychological disorder.