Granted Patent B2

US 12,420,097 · App. 17/751,167 · Granted Sep 23, 2025

Inventors: Paul Rockley (Corona Del Mar, CA); Thomas W. Harold (Prior Lake, MN); James R. Chiapetta (Delano, MN)

Assignee: i-Lumen Scientific, Inc.

A61N1/36046A61N1/0484A61N1/36031

Abstract

Claims (30)

1. A method of treating, arresting, and/or reversing disease progress in a patient having a vision disorder using a therapy delivery system comprising:

activating a phosphene threshold test routine;

delivering a phosphene threshold test signal by application of electrical energy to the eye via electrodes positioned on the patient's skin over or near the eye, wherein the phosphene threshold test signal comprises a plurality of electrical pulses which ramp from a first energy level toward a relatively higher second energy level until the response indicating occurrence of phosphenes is received;

identifying a threshold at which phosphenes are occurring in the patient's visual system by:

querying the patient as to whether a phosphene was observed;

receiving a response from the patient that a phosphene was observed;

based on the patient response, recording data on a particular pattern or morphology of the observed phosphene and the threshold;

setting one or more therapy delivery parameters relative to the threshold at which phosphenes are occurring; and

using one or more electrodes placed near the eye to sense for the occurrence of phosphenes.

2. The method of claim 1 wherein the therapy delivery system has stored program parameters for a therapy delivery routine prior to the delivery of the phosphene threshold test signal, the method further comprising defining the phosphene threshold test signal using the parameters for the therapy delivery routine.

3. The method of claim 1 wherein the response indicating occurrence of phosphenes includes receiving an audible or motion based actuation of a control signal by the patient.

4. The method of claim 1 wherein the step of setting one or more therapy delivery parameters comprises setting the therapy delivery parameters below the phosphene threshold.

5. The method of claim 1 wherein the step of setting one or more therapy delivery parameters comprises setting the therapy delivery parameter at the phosphene threshold.

6. The method of claim 1 wherein the step of setting one or more therapy delivery parameters comprises setting the therapy delivery parameters above the phosphene threshold.

7. The method of claim 1 wherein the step of delivering a phosphene threshold test signal is performed in a series of iterations in which:

A. a phosphene threshold test signal is issued; and

B. the patient is queried as to whether a phosphene was observed;

wherein if the patient indicates that no phosphene was observed at B, the phosphene threshold test signal is modified and the iterative analysis returns to A; or

if the patient indicates that a phosphene was observed, the system concludes that the last used parameters of the phosphene threshold test signal met the phosphene threshold.

8. The method of claim 1 wherein the steps of delivering a phosphene threshold test signal and identifying a threshold at which phosphenes are occurring in the patient's visual system are performed as follows:

starting with a first parameter set, applying a first phosphene test signal;

determining whether a patient response indicating presence of phosphenes is received responsive to the applied first phosphene test signal;

finding that no patient response indicating presence of phosphenes was received responsive to the applied first phosphene test signal;

adjusting at least one parameter of the first parameter set to define a second phosphene test signal;

retesting by applying the second phosphene test signal; and

repeating the adjusting and retesting steps until a patient response indicating presence of phosphenes is received.

9. The method of claim 8 , wherein the step of adjusting at least one parameter comprises increasing an amplitude parameter while holding a pulse width parameter fixed.

10. The method of claim 8 , wherein the step of adjusting at least one parameter comprises increasing a pulse width parameter while holding an amplitude parameter fixed.

11. The method of claim 8 , wherein the step of adjusting at least one parameter comprises changing both a pulse width parameter and an amplitude parameter.

12. The method of claim 8 , wherein the step of adjusting at least one parameter comprises changing a frequency parameter.

Assignments (5)

Continuity (3)

References Cited (267)