Testing Efficacy of Therapeutic Mechanical or Electrical Nerve or Muscle Stimulation
First Claim
1. A system of testing the efficacy of therapeutic stimulation applied to a patient by a therapy delivery device to alleviate one of incontinence or sexual dysfunction comprising:
- an evoked response detector having an evoked response sense electrode adapted to be applied to a patient'"'"'s body, the evoked response detector adapted to display an evoked response to stimulation applied to the patient'"'"'s body; and
a therapy delivery device operable in a therapy delivery mode to deliver a therapy stimulation regimen to a stimulation site of a patient'"'"'s body and a test mode for delivering test stimulation regimens to the stimulation site, the therapy delivery device further comprising means operable in the test mode for formulating series of test stimulation regimens and applying each test stimulation regimen to the stimulation site while the evoked response detector detects any evoked response to each test stimulation regimen, whereby a test stimulation regimen that causes an optimal evoked response may be determined.
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Accused Products
Abstract
Methods and apparatus for testing of the efficacy of therapeutic stimulation of pelvic nerves or musculature to alleviate one of incontinence or sexual dysfunction are disclosed. A therapy delivery device is operable in a therapy delivery mode and a test mode and an evoked response detector is employed in the test mode to detect the evoked response to applied test stimuli. The test stimuli parameters of the test stimulation regimen are adjusted prior to delivery of each test stimulation regimen, and the evoked responses to the applied test stimulation regimens are compared to ascertain an optimal test stimulation regimen. The therapy stimulation regimen parameters are selected as a function of the test electrical stimulation parameters causing the optimal evoked response.
353 Citations
20 Claims
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1. A system of testing the efficacy of therapeutic stimulation applied to a patient by a therapy delivery device to alleviate one of incontinence or sexual dysfunction comprising:
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an evoked response detector having an evoked response sense electrode adapted to be applied to a patient'"'"'s body, the evoked response detector adapted to display an evoked response to stimulation applied to the patient'"'"'s body; and
a therapy delivery device operable in a therapy delivery mode to deliver a therapy stimulation regimen to a stimulation site of a patient'"'"'s body and a test mode for delivering test stimulation regimens to the stimulation site, the therapy delivery device further comprising means operable in the test mode for formulating series of test stimulation regimens and applying each test stimulation regimen to the stimulation site while the evoked response detector detects any evoked response to each test stimulation regimen, whereby a test stimulation regimen that causes an optimal evoked response may be determined. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A method of testing the efficacy of therapeutic stimulation applied to a patient by a therapy delivery device to alleviate one of incontinence or sexual dysfunction comprising:
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operating the therapy delivery device in a test mode, and;
(a) applying an evoked response sense electrode to the patient'"'"'s body and coupling the evoked response sense electrode to an evoked response detector;
(b) applying a test stimulation regimen to body tissues at a stimulation site;
(c) operating the evoked response detector to detect any evoked response to the applied test stimulation regimen;
(d) adjusting one or both of test stimulation parameters and the stimulation site and repeating steps (c) and (d); and
(e) identifying a maximal evoked response and an optimal therapy stimulation regimen; and
operating the therapy delivery device in a therapy delivery mode to deliver the optimal therapy stimulation regimen to the patient'"'"'s body. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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17. A method of determining the efficacy of electrical stimulation of sphincter musculature of the pelvic floor that spontaneously exhibits an EMG to control incontinence comprising:
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inserting an EMG sense electrode into relation with the sphincter musculature;
detecting the EMG of the sphincter musculature;
determining a stimulation site of a tissue stimulation electrode of a medical electrical lead from the detected EMG;
implanting the medical electrical lead by positioning the stimulation electrode at the stimulation site;
coupling the medical electrical lead to an implantable pulse generator capable of operating in a programmed therapy delivery mode and a test mode;
disposing an evoked response sense electrode at a sense site of the patient'"'"'s body;
operating the implantable pulse generator in the test mode applying a test stimulation regimen through the tissue stimulation electrode to the stimulation site;
detecting at the sense electrode an evoked response to test stimuli of the test stimulation regimen;
determining optimal therapy stimulation parameters from one or more detected evoked response; and
adjusting a parameter of the programmed therapy stimulation mode to reflect the optimal therapy stimulation parameters. - View Dependent Claims (18, 19, 20)
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Specification