Implantable medical lead including voiding event sensor

• US 8,295,933 B2
• Filed: 05/30/2007
• Issued: 10/23/2012
• Est. Priority Date: 05/30/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T., Rondoni, John C.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US11/755,578
• Publication Number:
  US 20080300650A1
• Time in Patent Office: 1,973 Days
• Field of Search: 607/2, 607/40, 607/41, 607/115, 607/116, 600/29, 600/30, 600/549, 600/573
• US Class Current: 607/41
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An implantable medical lead includes at least one stimulation electrode and at least one sensor configured to generate an electrical signal that varies as a function of a parameter associated with a voiding event of a patient. In some embodiments, the sensor may be at least one of a microphone that captures sounds associated with voiding events, a pressure sensor, a flow sensor, a strain gauge, a physiological parameter sensing electrode or a temperature sensor. The electrical signal generated by the sensor may used to detect an occurrence of a voiding event. Thus, the lead may be coupled wirelessly or via a wired connection to a device that processes the electrical signal from the sensor, generates voiding information based on the electrical signal, and in some cases, records the voiding information for later retrieval and analysis.

Claims

1. A system comprising:

a medical lead comprising;

a lead body extending between a proximal end configured to be coupled to a medical device and a distal end,

a sensor coupled to the lead body between the proximal end and the distal end, wherein the sensor is configured to generate an electrical signal that varies as a function of a parameter associated with a voiding event of a patient, wherein the voiding event comprises at least one of a urinary voiding event or a fecal voiding event, and

a stimulation electrode coupled to the lead body between the proximal end and the distal end; and

a voiding monitor that receives the electrical signal from the sensor and generates voiding information based on the electrical signal.

2. The system of claim 1, further comprising a memory to store the voiding information.

3. The system of claim 2, further comprising a medical device programmer, wherein the medical device programmer contains the memory.

4. The system of claim 1, wherein the sensor comprises at least one of an impedance sensor, a strain gauge, a microphone, a thermometer or a flow sensor.

5. The system of claim 1, wherein the voiding monitor processes the electrical signals to detect the voiding event and generates voiding information in response to detecting the voiding event.

6. The system of claim 5, wherein the voiding information comprises at least one of an indication of an occurrence of the voiding event, a portion of the electrical signal associated with the voiding event or a time of the voiding event.

7. The system of claim 1, further comprising an external programmer that includes a user interface for displaying the voiding information, wherein the voiding monitor includes a wireless telemetry module configured to transmit the voiding information to the external programmer.

8. The system of claim 1, further comprising an electrical stimulator coupled to the medical lead, wherein the electrical stimulator is configured to deliver electrical stimulation therapy to the patient via the stimulation electrode to control incontinence.

9. The system of claim 1, wherein the sensor is coupled to the lead body proximate to the distal end of the lead body.

10. The system of claim 1, wherein the sensor comprises at least one of a pressure sensor or an electromyography (EMG) sensor.

11. The system of claim 1, wherein the parameter comprises at least one of nerve activity, bladder volume, bladder pressure, bladder impedance, sphincter pressure, bowel pressure, motion of a portion of an intestines, motion of a sigmoid colon, motion of a rectum or a sound associated with the voiding event.

12. The system of claim 11, wherein the parameter comprises a sound associated with the voiding event.

13. The system of claim 1, wherein the stimulation electrode is disposed on the lead body proximate to the sensor.

14. The system of claim 1, wherein the lead body includes a medially located portion positioned between the distal end and the proximal end, wherein the stimulation electrode is positioned on the medially located portion of the lead body.

15. The system of claim 1, wherein the sensor comprises a first sensor, the medical lead further comprising a second sensor coupled to the lead body proximate to the distal end of the lead body, the first sensor and the second sensor each being configured to generate the electrical signal that varies as a function of the parameter.

16. The system of claim 1, wherein the sensor comprises a first sensor, the electrical signal comprises a first electrical signal, and the parameter comprises a first parameter, the medical lead further comprising a second sensor coupled to the lead body proximate to the distal end of the lead body, wherein the second sensor is configured to generate a second electrical signal that varies as a function of a second parameter associated with the voiding event.

17. The system of claim 1, further comprising the medical device, wherein the medical device comprises the voiding monitor.

18. A method comprising:

receiving, with a voiding monitor, an electrical signal from a sensor carried by a medical lead implanted in a patient, wherein the electrical signal varies as a function of a parameter associated with a voiding event of a patient, wherein the voiding event comprises at least one of a urinary voiding event or a fecal voiding event, the medical lead further comprising;

a lead body extending between a proximal end configured to be coupled to a medical device and a distal end, wherein the sensor is coupled to the lead body between the proximal end and the distal end, and

a stimulation electrode coupled to the lead body between the proximal end and the distal end; and

generating, with the voiding monitor, voiding information based on the electrical signal.

19. The method of claim 18, further comprising storing the voiding information in a memory of a device.

20. The method of claim 19, wherein the device comprises a medical device programmer, and storing the voiding information in a memory of the device comprises transmitting the voiding information to the medical device programmer via wireless telemetry.

21. The method of claim 18, wherein the parameter comprises at least one of nerve activity, bladder volume, bladder pressure, bladder impedance, sphincter pressure, bowel pressure, motion of a portion of an intestines, motion of a sigmoid colon, motion of a rectum or a sound associated with the voiding event.

22. The method of claim 18, wherein the sensor comprises at least one of an impedance sensor, a pressure sensor, a strain gauge, a microphone, a thermometer, an electromyography (EMG) sensor, or a flow sensor.

23. The method of claim 18, further comprising determining whether the voiding event occurred based on the electrical signal, and wherein generating voiding information comprises generating voiding information upon determining that the voiding event occurred.

24. The method of claim 23, wherein determining whether the voiding event occurred based on the electrical signal comprises at least one of comparing a characteristic of the electrical signal to a threshold value or comparing a sample of the electrical signal to a signal template.

25. The method of claim 24, wherein the characteristic of the electrical signal comprises a first power of one or more frequency components of the electrical signal, a second power associated with a portion of the electrical signal or an amplitude of the electrical signal.

26. The method of claim 23, further comprising delivering electrical pulses to the patient via the stimulation electrodes upon determining that the voiding event occurred.

27. A method comprising:

implanting a medical lead in a patient, the medical lead comprising;

a lead body extending between a proximal end configured to be coupled to a medical device and a distal end,

a stimulation electrode coupled to the lead body between the proximal end and the distal end, and

a sensor configured to generate an electrical signal that varies as a function of a parameter associated with a voiding event of the patient, the voiding event comprising at least one of a urinary voiding event or a fecal voiding event, wherein the sensor is coupled to the lead body between the proximal end and the distal end; and

coupling the medical lead to a voiding monitor that receives the electrical signal from the sensor and generates voiding information based on the electrical signal.

28. The method of claim 27, wherein implanting the medical lead in the patient comprises implanting the medical lead proximate to one of a bladder, a urinary tract, a sacrum, an intestine or a rectum of the patient.