Implantable urinary tract monitor

• US 20050245840A1
• Filed: 04/28/2004
• Published: 11/03/2005
• Est. Priority Date: 04/28/2004
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Starkebaum, Warren L., Christopherson, Mark A.
• Application Number:
  US10/833,776
• Publication Number:
  US 20050245840A1
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61B 5/68 Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
• CPC Class Codes: A61B 5/6874 Bladder
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61K 31/54 having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame

Abstract

An implantable urinary tract monitor is configured for indwelling urodynamic testing, indwelling urinalysis, or both. A urinary tract monitor in accordance with the invention incorporates a fixation structure to selectively position the monitor at a tissue site within the bladder or urethra. In this manner, the monitor is implanted within the patient and, if desired, can accompany the patient throughout a routine of normal daily activities.

Claims

1. A monitor for placement within a urinary tract of a patient, the monitor comprising:

a monitor housing sized for introduction into a urethra of a patient;

an expandable frame mounted to the device housing to secure the device housing at a position within the urinary tract; and

a sensor to sense one or more physiological conditions within the urinary tract.

2. The monitor of claim 1, wherein the sensor is configured to sense one or more urodynamic parameters.

4. The monitor of claim 1, wherein the sensor is configured to sense one or more physical characteristics of urine in the urinary tract.

5. The monitor of claim 4, wherein the physical characteristics include presence of drug residue in the urine.

6. The monitor of claim 4, wherein the physical characteristics include presence of at least one of sugar, proteins, blood, keytones, bilirubin, bacteria, yeast cells, and parasites in the urine.

7. The monitor of claim 4, wherein the physical characteristics include glucose level.

8. The monitor of claim 4, further comprising a telemetry unit to transmit signals indicative of the sensed conditions.

9. The monitor of claim 1, wherein the expandable frame includes a wire grid formed from one of stainless steel, titanium, nitinol, and polymeric filament.

10. The monitor of claim 1, wherein the expandable frame is elastic and self-expandable.

11. The monitor of claim 1, wherein the monitor housing is substantially cylindrical in shape, and defines a diameter substantially less than a fully expanded diameter of the expandable frame.

12. The monitor of claim 1, further comprising a power source to power the sensor over a period of at least twenty-four hours.

13. The monitor of claim 1, wherein the expandable frame is formed from a degradable material, and the degradable material degrades over time to release the monitor housing.

14. The monitor of claim 1, further comprising a telemetry unit to periodically transmit signals indicative of the sensed conditions over a period of time.

3. The monitor of clam 2, wherein the urodynamic parameters includes at least one of urine pressure, urine flow, urine pH, temperature, and bladder contraction.

15. A monitor for placement within a urinary tract of a patient, the monitor comprising:

a monitor housing sized for introduction into a urethra of a patient;

a fixation structure to secure the device housing at a position within the urinary tract; and

a sensor to sense one or more physical characteristics of urine in the urinary tract.

16. The monitor of claim 15, wherein the physical characteristics include presence of drug residue in the urine.

17. The monitor of claim 15, wherein the physical characteristics include presence of at least one of sugar, proteins, blood, keytones, bilirubin, bacteria, yeast cells, and parasites in the urine.

18. The monitor of claim 15, wherein the physical characteristics include glucose level.

19. The monitor of claim 15, further comprising a telemetry unit to transmit signals indicative of the physical characteristics.

20. The monitor of claim 15, wherein the fixation structure includes an expandable frame.

21. The monitor of claim 20, wherein the expandable frame is degradable.

22. The monitor of claim 15, wherein the fixation structure includes a cavity formed in the monitor housing and a shaft to capture tissue within the cavity.

23. The monitor of claim 22, wherein the cavity includes a vacuum port for application of vacuum pressure to draw the tissue into the cavity.

24. The monitor of claim 22, wherein the shaft is sharpened to penetrate the tissue.

25. The monitor of claim 22, wherein the shaft is degradable.

26. The monitor of claim 15, further comprising a power source to power the sensor over a period of at least twenty-four hours.

27. The monitor of claim 15, further comprising a telemetry unit to periodically transmit signals indicative of the sensed conditions over a period of time.

28. A monitor for placement within a urinary tract of a patient, the monitor comprising:

a monitor housing sized for introduction into a urethra of a patient;

a fixation structure to secure the device housing at a position within the urethra; and

a sensor to sense one or more physiological conditions within the urinary tract.

29. The monitor of claim 28, wherein the sensor is configured to sense one or more urodynamic parameters.

31. The monitor of claim 28, wherein the sensor is configured to sense one or more physical characteristics of urine in the urinary tract.

32. The monitor of claim 31, wherein the physical characteristics include presence of drug residue in the urine.

33. The monitor of claim 31, wherein the physical characteristics include presence of at least one of sugar, proteins, blood, keytones, bilirubin, bacteria, yeast cells, and parasites in the urine.

34. The monitor of claim 31, wherein the physical characteristics include glucose level.

35. The monitor of claim 28, further comprising a telemetry unit to transmit signals indicative of the sensed conditions.

36. The monitor of claim 28, wherein the fixation structure includes an expandable frame.

37. The monitor of claim 36, wherein the expandable frame is degradable.

38. The monitor of claim 28, wherein the fixation structure includes a cavity formed in the monitor housing and a shaft to capture tissue within the cavity.

39. The monitor of claim 38, wherein the cavity includes a vacuum port for application of vacuum pressure to draw the tissue into the cavity.

40. The monitor of claim 28, wherein the shaft is sharpened to penetrate the tissue.

41. The monitor of claim 28, wherein the shaft is degradable.

42. The monitor of claim 28, further comprising a power source to power the sensor over a period of at least twenty-four hours.

43. The monitor of claim 28, further comprising a telemetry unit to periodically transmit signals indicative of the sensed conditions over a period of time.

30. The monitor of clam 29, wherein the urodynamic parameters includes at least one of urine pressure, urine flow, urine pH, temperature, and bladder contraction.

44. A system for monitoring a urinary tract of a patient, the monitor comprising:

a monitor including a monitor housing sized for introduction into a urethra of a patient, a fixation structure to secure the device housing at a position within the urinary tract, a sensor to sense one or more physiological conditions within the urinary tract, and a telemetry unit to transmit signals indicative of the sensed conditions; and

an external receiver to receive the transmitted signals and generate information based on the sensed conditions.

45. The system of claim 44, wherein the sensor is configured to sense one or more urodynamic parameters.

47. The system of claim 44, wherein the sensor is configured to sense one or more physical characteristics of urine in the urinary tract.

48. The system of claim 47, wherein the physical characteristics include presence of drug residue in the urine.

49. The system of claim 47, wherein the physical characteristics include presence of at least one of sugar, proteins, blood, keytones, bilirubin, bacteria, yeast cells, and parasites in the urine.

50. The system of claim 47, wherein the physical characteristics include glucose level.

51. The system of claim 44, wherein the fixation structure includes an expandable frame mounted to the device housing to secure the device housing at a position within the urinary tract.

52. The system of claim 44, wherein the fixation structure includes a cavity formed in the monitor housing and a shaft to capture tissue within the cavity.

53. The system of claim 44, wherein the external receiver includes a display to present information based on the received signals.

54. The system of claim 44, wherein the information includes indications of detection of one or more of the characteristics.

55. The system of claim 44, wherein the information includes levels of one or more of the characteristics.

56. The system of claim 44, wherein the information includes one or more therapy recommendations.

57. The system of claim 44, wherein the telemetry unit transmits the signals periodically over a period of time, thereby updating the indication of the sensed conditions.

58. The system of claim 44, wherein the external receiver includes a display to present information based on the received signals, the system further comprising:

a network server communicatively coupled to the external receiver to receive the information; and

one or more network clients communicatively coupled to the network server to view the information.

59. The system of claim 44, wherein the external receiver includes a portable receiver housing for portability by the patient.

60. The system of claim 44, further comprising a therapy device to deliver therapy to the patient, wherein the therapy device is responsive to one of the external receiver and the monitor to adjust the delivered therapy in response to the sensed conditions.

61. The system of claim 60, wherein the therapy device includes one of a neurostimulator and a drug pump.

46. The system of clam 45, wherein the urodynamic parameters includes at least one of urine pressure, urine flow, urine pH, temperature, and bladder contraction.

62. A method for monitoring a urinary tract of a patient, the method comprising:

introducing an endoscopic delivery device into a urethra of a patient;

positioning a monitor within the urinary tract of the patient with the endoscopic delivery device;

securing the monitor to tissue within the urinary tract with an expandable frame;

sensing one or more physiological conditions within the urinary tract via a sensor in the monitor; and

transmitting signals indicative of the sensed conditions from the sensor to an external receiver.

63. The method of claim 62, wherein the sensor is configured to sense one or more urodynamic parameters.

65. The method of claim 62, wherein the sensor is configured to sense one or more physical characteristics of urine in the urinary tract.

66. The method of claim 65, wherein the physical characteristics include presence of drug residue in the urine.

67. The method of claim 65, wherein the physical characteristics include presence of at least one of sugar, proteins, blood, keytones, bilirubin, bacteria, yeast cells, and parasites in the urine.

68. The method of claim 65, wherein the physical characteristics include glucose level.

69. The method of claim 62, further comprising presenting information based on the received signals on a display.

70. The method of claim 69, wherein the information includes indications of detection of one or more of the characteristics.

71. The method of claim 69, wherein the information includes levels of one or more of the characteristics.

72. The method of claim 69, wherein the information includes one or more therapy recommendations.

73. The method of claim 62, further comprising transmitting the signals periodically over a period of time, thereby updating the indication of the sensed conditions.

64. The method of clam 63, wherein the urodynamic parameters includes at least one of urine pressure, urine flow, urine pH, temperature, and bladder contraction.

74. A method for monitoring a urinary tract of a patient, the method comprising:

introducing an endoscopic delivery device into a urethra of a patient;

positioning a monitor within the urinary tract of the patient with the endoscopic delivery device;

securing the monitor to tissue within the urinary tract with an expandable frame;

sensing one or more physical characteristics of urine in the urinary tract via a sensor in the monitor; and

transmitting signals indicative of the sensed conditions from the sensor to an external receiver.

75. The method of claim 74, wherein the physical characteristics include presence of drug residue in the urine.

76. The method of claim 74, wherein the physical characteristics include presence of at least one of sugar, proteins, blood, keytones, bilirubin, bacteria, yeast cells, and parasites in the urine.

77. The method of claim 74, wherein the physical characteristics include glucose level.

78. The method of claim 74, further comprising presenting information based on the received signals on a display.

79. The method of claim 78, wherein the information includes indications of detection of one or more of the characteristics.

80. The method of claim 78, wherein the information includes levels of one or more of the characteristics.

81. The method of claim 78, wherein the information includes one or more therapy recommendations.

82. The method of claim 74, further comprising transmitting the signals periodically over a period of time, thereby updating the indication of the sensed conditions.

83. A monitor for placement within a urinary tract of a patient, the monitor comprising:

a monitor housing sized for introduction into a urethra of a patient;

means for securing the device housing at a position within the urinary tract; and

means for sensing one or more physical characteristics of urine in the urinary tract.

84. The monitor of claim 83, wherein the physical characteristics include presence of drug residue in the urine.

85. The monitor of claim 83, wherein the physical characteristics include presence of at least one of sugar, proteins, blood, keytones, bilirubin, bacteria, yeast cells, and parasites in the urine.

86. The monitor of claim 83, wherein the physical characteristics include glucose level.

87. The monitor of claim 83, further comprising means for transmitting signals indicative of the physical characteristics.