Impedance-based bladder sensing

• US 9,061,146 B2
• Filed: 10/28/2005
• Issued: 06/23/2015
• Est. Priority Date: 10/28/2005
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): GHAND, JENNIFER LEIGH-STEWAR
• Application Number:
  US11/261,443
• Publication Number:
  US 20070100387A1
• Time in Patent Office: 3,525 Days
• Field of Search: 607/40, 607/41, 600/547
• US Class Current: 1/1
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/6874 Bladder
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Systems that sense the volume, activity or other parameters of the urinary bladder are described. The systems include at least two electrodes that are implanted at respective locations proximate the wall of the bladder, and may be located substantially opposite each other with respect to a center of the bladder. At least one of the electrodes receives an electrical signal emitted by another of the electrodes. Systems according to the invention detect an impedance through the bladder based on the signal, e.g., based on one or both of the current or voltage of the signal. Based on the detected impedance, the systems sense one or more parameters of the bladder, such as volume, activity, or the like, which influence the impedance. The detected impedance, or bladder parameter information derived from the impedance, may be stored for short- or long-term monitoring, or used to control delivery of a therapy to a patient.

Claims

1. A method comprising:

emitting an electrical signal from a first electrode implanted proximate to a wall of a bladder of a patient at a first location;

receiving the electrical signal via a second electrode implanted proximate to the wall of the bladder at a second location; and

detecting an impedance between the first electrode and second electrode through the bladder based on at least one parameter of the signal,

wherein the first and second electrodes are located within a volume defined by an inner surface of the wall of the bladder.

2. The method of claim 1, wherein the first and second electrodes are located substantially opposite each other relative to a center of the bladder.

3. The method of claim 1, further comprising controlling delivery of a therapy to the patient based on the detected impedance to alleviate urinary incontinence.

4. The method of claim 3, wherein controlling delivery of a therapy comprises controlling delivery of electrical stimulation to at least one of a pelvic floor nerve or a pelvic floor muscle.

5. The method of claim 3, wherein controlling delivery of a therapy comprises:

determining whether the bladder has reached a threshold level of fullness based on the detected impedance; and

one of initiating, terminating, or modifying the therapy based on the determination.

6. The method of claim 3, wherein controlling delivery of a therapy comprises:

determining whether the bladder is contracting based on the detected impedance; and

one of initiating, terminating, or modifying the therapy based on the determination.

7. The method of claim 3, wherein controlling delivery of a therapy comprises controlling delivery of the therapy from an implantable medical device to the patient.

8. The method of claim 7, wherein the first and second electrodes are electrically coupled to the implantable medical device via respective leads that attach to the wall of the bladder.

9. The method of claim 7, wherein the first and second electrodes are electrically coupled to an implantable module that is separate from the implantable medical device.

10. The method of claim 1, further comprising presenting information relating to at least one of filling or emptying of the bladder to a user based on the detected impedance.

11. The method of claim 10, further comprising determining whether the bladder has reached a threshold level of fullness based on the detected impedance, wherein presenting information to a user comprising alerting the user that the bladder has reached the threshold level of fullness based on the determination.

12. The method of claim 10, further comprising storing information relating to the impedance over a period of time, wherein presenting information relating to at least one of filling or emptying of the bladder comprises presenting information relating to at least one of filling or emptying of the bladder based on the stored information.

13. The method of claim 1, wherein the first and second electrodes are electrically coupled to an implantable module that is implanted on or within the bladder wall.

14. The method of claim 13, further comprising endoscopically implanting the implantable module.

15. The method of claim 1, wherein the at least one parameter of the signal comprises at least one of voltage of the signal or current of the signal.

16. The method of claim 1, wherein the at least one parameter of the signal is detected using the first and second electrode.

17. A system comprising:

a first electrode configured to be implanted proximate to a wall of a bladder of a patient at a first location;

a second electrode configured to be implanted proximate to the wall of the bladder at a second location; and

impedance measurement circuitry electrically coupled to the first and second electrodes that emits an electrical signal via the first electrode, receives the electrical signal via the second electrode, and detects an impedance between the first electrode and second electrode through the bladder based on at least one parameter of the signal,

wherein the first and second electrodes are configured to be implanted within a volume defined by an inner surface of the wall of the bladder.

18. The system of claim 17, wherein the first and second locations are located substantially opposite each other relative to a center of the bladder.

19. The system of claim 17, further comprising an implantable medical device that delivers a therapy to the patient based on the detected impedance to alleviate urinary incontinence.

20. The system of claim 19, wherein the implantable medical device delivers electrical stimulation to at least one of a pelvic floor nerve or a pelvic floor muscle based on the detected impedance.

21. The system of claim 19, further comprising a processor that determines whether the bladder has reached a threshold level of fullness based on the detected impedance, and one of initiates, terminates, or modifies the delivery of therapy by the implantable medical device based on the determination.

22. The system of claim 19, further comprising a processor that determines whether the bladder is contracting based on the detected impedance, and one of initiates, terminates, or modifies the delivery of therapy by the implantable medical device based on the determination.

23. The system of claim 19, wherein the implantable medical device comprises the impedance measurement circuitry, the system further comprising first and second leads configured to be attached to the bladder wall that electrically couple first and second electrodes, respectively, to the implantable medical device.

24. The system of claim 19, further comprising an implantable module that is separate from the implantable medical device and comprises the impedance measurement circuitry, wherein the first and second electrodes are electrically coupled to the implantable module.

25. The system of claim 17, further comprising a user interface that presents information relating to at least one of filling or emptying of the bladder to a user based on the detected impedance.

26. The system of claim 25, further comprising a processor that determines whether the bladder has reached a threshold level of fullness based on the detected impedance, and alerts the user that the bladder has reached the threshold level of fullness via the user interface based on the determination.

27. The system of claim 26, further comprising:

a memory to store information relating to the impedance over a period of time; and

a processor that presents information to a user relating to at least one of filling or emptying of the bladder via the user interface based on the stored information.

28. The system of claim 17, wherein the at least one parameter of the signal comprises at least one of voltage of the signal or current of the signal.

29. The system of claim 17, wherein the at least one parameter of the signal is detected by the impendence measurement circuit via the first and second electrode.

30. A system comprising:

an implantable module configured to be implanted on or within a wall of a bladder of a patient;

a first electrode electrically coupled to the implantable module and configured to be located proximate to the wall of the bladder at a first location; and

a second electrode electrically coupled to the implantable module and configured to be located proximate to the wall of the bladder at a second location, wherein the implantable module emits an electrical signal via the first electrode, detects the electrical signal via the second electrode, and detects an impedance between the first and second electrodes through the bladder based on at least one parameter of the signal,

wherein the first and second electrodes are configured to be implanted within a volume defined by an inner surface of the wall of the bladder.

31. The system of claim 30, wherein the implantable module comprises a housing, and at least one of the first electrode or second electrode is formed on or within the housing.

32. The system of claim 30, wherein a lead electrically couples at least one of the first electrode or the second electrode to the implantable module.

33. The system of claim 30, wherein the implantable module comprises a housing and the housing comprises a fixation structure configured to affix the housing to the interior surface of the bladder.

34. The system of claim 30, wherein the implantable module comprises a housing, and the housing comprises a vacuum cavity configured to capture a portion of the interior surface of the bladder and a fixation element configured to penetrate the captured portion.

35. The system of claim 30, wherein the implantable module comprises a housing sized for endoscopic implantation on the internal surface of the bladder via a urethra of the patient.

36. The system of claim 30, wherein the implantable module comprises wireless telemetry circuitry, and transmits information via the telemetry circuitry based on the detected impedance.

37. The system of claim 36, further comprising an implantable medical device, wherein the implantable medical device receives the information transmitted by implantable module, and delivers a therapy to alleviate urinary incontinence based on the information.

38. The system of claim 36, further comprising:

an external programmer; and

an implantable medical device that delivers a therapy to treat urinary incontinence, wherein the external programmer receives the information transmitted by the implantable module and controls delivery of the therapy by the implantable medical device based on the information.

39. The system of claim 36, further comprising an external programmer that receives the information transmitted by the implantable module, and presents information relating to at least one of filling or emptying of the bladder to at least one of the patient or another user based on the information transmitted by the implantable module.

40. The system of claim 30, wherein the implantable module comprises a memory to store the information relating to the detected impedance.

41. The system of claim 30, wherein the at least one parameter of the signal comprises at least one of voltage of the signal or current of the signal.

42. The system of claim 30, wherein the at least one parameter of the signal is detected by the implantable module via the first and second electrodes.