Incontinence therapy

• US 9,724,511 B2
• Filed: 09/02/2016
• Issued: 08/08/2017
• Est. Priority Date: 04/24/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wei, Xuan K., Bonde, Eric H., Miesel, Keith A., Lent, Mark S., Molnar, Gregory F.
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US15/256,369
• Publication Number:
  US 20160367803A1
• Time in Patent Office: 340 Days
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• 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

Abstract

Techniques for managing urinary or fecal incontinence include delivering a first type of therapy to generate a first physiological response and, upon detecting a trigger event, delivering a second type of therapy to generate a second physiological response. The first type of therapy can be delivered on a substantially regular basis, while the second type of therapy is delivered as needed to provide an additional boost of therapy. The trigger event for activating the delivery of the second type of therapy may include input from a sensor that indicates a bladder condition, patient activity level or patient posture, or patient input. In some examples, the therapy is stimulation therapy.

Claims

1. A medical system comprising:

a therapy delivery module configured to generate and deliver electrical stimulation therapy to a patient, the electrical stimulation therapy configured to reduce a likelihood of at least one of a urinary voiding event or a fecal voiding event;

at least one of a sensor or a user input mechanism, wherein the sensor is configured to sense a patient ammeter indicative of an increased probability of at least one of the urinary voiding event or fecal voiding event, and wherein the user input mechanism is configured to receive user input from a user indicative of at least one of an imminent involuntary voiding event of the patient or an increased possibility of an occurrence of an involuntary voiding event of the patient; and

processing circuitry programmed to;

detect, based on input received from at least one of the sensor or the user input mechanism, a trigger event that triggers the processing circuitry to control delivery of the electrical stimulation therapy,

responsive to detecting the trigger event, determine a number of trigger events that have been detected within a predetermined interval of time,

determine that the number of trigger events does not exceed a threshold value, and

responsive to determining that the number of trigger events does not exceed the threshold value, control the therapy delivery module to deliver the electrical stimulation therapy to the patient according to a stimulation therapy program selected to reduce the likelihood of at least one of the urinary voiding event or the fecal voiding event.

2. The medical system of claim 1, further comprising the sensor, wherein the processing circuitry is configured to detect the trigger event from input received from the sensor.

3. The medical system of claim 2, wherein the sensor is configured to generate a signal indicative of at least one of a bladder impedance value, a current or voltage amplitude value for a sacral or pudendal afferent nerve signal, or an electromyogram signal for a muscle in a pelvic region of the patient.

4. The medical system of claim 1, further comprising the user input mechanism, wherein the processing circuitry is configured to detect the trigger event based on input received from the user input mechanism.

5. The medical system of claim 1, wherein the sensor is configured to generate a signal indicative of patient activity or posture as the patient parameter, wherein the processing circuitry is configured to receive input from the sensor indicative of the signal and detect the trigger event based on the input.

6. The medical system of claim 1, wherein the processing circuitry is configured to control the therapy delivery module to deliver the electrical stimulation therapy to the patient for a predetermined period of time following detection of the trigger event.

7. The medical system of claim 1, wherein the processing circuitry is configured to generate a patient notification in response to determining that the number of trigger events detected within the predetermined interval of time is greater than or equal to the threshold value.

8. The medical system of claim 1, wherein the processing circuitry is configured to generate a patient notification that indicates prospective delivery of the electrical stimulation therapy prior to controlling the therapy delivery module to deliver the electrical stimulation therapy to the patient.

9. The medical system of claim 1, wherein the electrical stimulation therapy is a second electrical stimulation therapy configured to generate a second physiological effect, and wherein the therapy delivery module is configured to generate and deliver a first electrical stimulation therapy configured to generate a first physiological effect that is different than the second physiological effect.

10. The medical system of claim 9, wherein the first physiological effect comprises inhibiting contraction of a bladder of the patient, and the second physiological effect comprises promoting contraction of one or more of a bladder outlet of the patient, an internal urinary sphincter of the patient, an external urinary sphincter of the patient, or periurethral muscles of the patient.

11. The medical system of claim 9, wherein the first electrical stimulation therapy is delivered to the patient on a regular basis and the second electrical stimulation therapy is delivered to the patient only responsive to detecting the trigger event and determining that the number of trigger events does not exceed the threshold value, the trigger event being indicative of at least one of an imminent involuntary voiding event or an increased possibility of an occurrence of an involuntary voiding event.

12. The medical system of claim 9, wherein the therapy delivery module is configured to deliver the second electrical stimulation therapy by at least delivering a plurality of electrical stimulation signals during a plurality of therapy periods that are separated by a minimum inter-therapy interval to minimize muscle fatigue.

13. The medical system of claim 9, wherein the therapy delivery module is configured to deliver the first stimulation therapy to at least one of a pudendal nerve or a sacral nerve and deliver the second stimulation therapy at least to one of a hypogastric nerve, the pudendal nerve, the sacral nerve, a dorsal penile nerve, a dorsal clitoral nerve, an external urinary sphincter, or periurethral muscles.

14. The medical system of claim 9, wherein the therapy delivery module is configured to deliver the second electrical stimulation therapy according to a first set of stimulation parameters for a first period of time and according to a second set of stimulation parameters different than the first set of stimulation parameters for a subsequent period of time.

15. The medical system of claim 9, wherein the processing circuitry is configured to:

detect the trigger event during delivery of the first electrical stimulation therapy to the patient;

determine that the number of trigger events detected within the predetermined interval of time is greater than or equal to the threshold value; and

responsive to determining that the number of trigger events is greater than or equal to the threshold value, withhold delivery of the second electrical stimulation therapy from the patient.

16. A medical system comprising:

means for generating and delivering electrical stimulation therapy to a patient, the electrical stimulation therapy configured to reduce a likelihood of at least one of urinary voiding events or fecal voiding events;

means for at least one of;

sensing a patient parameter indicative of an increased probability of least one of the urinary voiding event or the fecal voiding event, or receiving user input from a user indicative of at least one of an imminent involuntary voiding event of the patient or an increased possibility of an occurrence of an involuntary voiding event of the patient;

means for detecting, based on input received from at least one of the means for sensing a patient parameter or means for receiving user input from a user, a trigger event that triggers the means for generating and delivering the electrical stimulation therapy to deliver the electrical stimulation therapy;

means for, responsive to detecting the trigger event, determining a number of trigger events that have been detected within a predetermined interval of time;

means for determining that the number of trigger events does not exceed a threshold value; and

means for, responsive to determining that the number of trigger events does not exceed the threshold value, controlling the means for generating and delivering the electrical stimulation therapy to deliver the electrical stimulation therapy to the patient according to a stimulation therapy program selected to reduce the likelihood of at least one of the urinary voiding event or the fecal voiding event.

17. A method comprising:

at least one of;

sensing, by a sensor, a patient parameter indicative of an increased probability of at least one of the urinary voiding event or the fecal voiding event, or receiving, by a user input, mechanism, user input from a user indicative of at least one of an imminent involuntary voiding event of the patient or an increased possibility of an occurrence of an involuntary voiding event of the patient;

detecting, by processing circuitry and based on input received from at least one of the sensor or the user input mechanism, a trigger event that triggers the processing circuitry to control delivery of electrical stimulation therapy;

responsive to detecting the trigger event, determining, by the processing circuitry, a number of trigger events that have been detected within a predetermined interval of time;

determining, by the processing circuitry, that the number of trigger events does not exceed a threshold value for the predetermined interval of time; and

responsive to determining that the number of trigger events does not exceed the threshold value, controlling, by the processing circuitry, a therapy delivery module to deliver the electrical stimulation therapy to a patient, the electrical stimulation therapy configured to reduce a likelihood of at least one of a urinary voiding event or a fecal voiding event.

18. The method of claim 17, further comprising:

sensing, by the sensor, the patient parameter; and

receiving input from the sensor, wherein detecting the trigger event comprises detecting the trigger event based on the input received from the sensor.

19. The method of claim 18, wherein the patient parameter is indicative of at least one of a bladder impedance value, a current or voltage amplitude value for a sacral or pudendal afferent nerve signal, or an electromyogram signal for a muscle in a pelvic region of the patient.

20. The method of claim 17, further comprising:

receiving input indicative of the user input indicative of at least one of the imminent involuntary voiding event of the patient or the increased possibility of the occurrence of the involuntary voiding event of the patient, wherein detecting the trigger event comprises detecting the trigger event based on the received input.

22. The method of claim 17, wherein the electrical stimulation therapy is a second electrical stimulation therapy configured to generate a second physiological effect, and wherein the method further comprises controlling, by the processing circuitry, delivery of a first electrical stimulation therapy configured to generate a first physiological effect that is different than the second physiological effect.

23. The method of claim 22, wherein the first physiological effect comprises inhibiting contraction of a bladder of the patient, and the second physiological effect comprises promoting contraction of one or more of a bladder outlet of the patient, an internal urinary sphincter of the patient, an external urinary sphincter of the patient, or periurethral muscles of the patient.

24. The method of claim 22, wherein the first electrical stimulation therapy is delivered to the patient on a regular basis and the second electrical stimulation therapy is delivered to the patient only responsive to detecting the trigger event and determining that the number of trigger events does not exceed the threshold value, the trigger event being indicative of at least one of an imminent involuntary voiding event or an increased possibility of an occurrence of an involuntary voiding event.

25. The method of claim 22, wherein controlling delivery of the first stimulation therapy comprises controlling delivery of the first stimulation therapy to at least one of a pudendal nerve or a sacral nerve, and wherein controlling delivery of the second stimulation therapy comprises controlling delivery of the second stimulation therapy at least to one of a hypogastric nerve, the pudendal nerve, the sacral nerve, a dorsal penile nerve, a dorsal clitoral nerve, an external urinary sphincter, or periurethral muscles.

26. The method of claim 22, wherein controlling delivery of the second electrical stimulation therapy comprises controlling delivery of the second electrical stimulation therapy according to a first set of stimulation parameters for a first period of time and according to a second set of stimulation parameters different than the first set of stimulation parameters for a subsequent period of time.

27. The method of claim 22, further comprising:

detecting the trigger event during delivery of the first electrical stimulation therapy to the patient;

determining that the number of trigger events detected within the predetermined interval of time is greater than or equal to the threshold value; and

responsive to determining that the number of trigger events is greater than or equal to the threshold value, withholding delivery of the second electrical stimulation therapy from the patient.

28. The method of claim 17, further comprising generating, by the processing circuitry, a patient notification in response to determining that the number of trigger events detected within the predetermined interval of time is greater than or equal to the threshold value.

29. The method of claim 17, wherein controlling delivery of the electrical stimulation therapy comprises controlling delivery of the electrical stimulation therapy to the patient for a predetermined period of time following detecting the trigger event.

21. The method of 17, further comprising:

generating, via a sensor, a signal indicative of patient activity or posture, and

receiving, by the processing circuitry, input from the sensor indicative of the signal, wherein detecting the trigger event comprises detecting the trigger event based on the input.