STENT MONITORING ASSEMBLY AND METHOD OF USE THEREOF

• US 20160038087A1
• Filed: 03/14/2014
• Published: 02/11/2016
• Est. Priority Date: 03/15/2013
• Status: Abandoned Application

• Current Assignee: Canary Medical Switzerland AG
• Original Assignee: Canary Medical Switzerland AG
• Inventors: Hunter, William L.
• Application Number:
  US14/776,646
• Publication Number:
  US 20160038087A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/067 using accelerometers or gyroscopes
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2250/0085 Identification means; Administration of patients
• CPC Class Codes: A61F 2250/0096 : Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

Assemblies are provided comprising a stent and a sensor positioned on and/or in the stent. Within certain aspects the sensors are wireless sensors, and include for example one or more fluid pressure sensors, contact sensors, position sensors, accelerometers, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolic sensors, mechanical stress sensors and/or temperature sensors. Within certain aspects these stents may be utilized to assist in stent placement, monitor stent function, identify complications of stent treatment, monitor physiologic parameters and/or medically image a body passageway, e.g., a vascular lumen.

Claims

1. An assembly comprising a stent;

and a sensor positioned on or within said stent.

2. The assembly according to claim 1 wherein the sensor is positioned on an outer wall of the stent.

3. The assembly according to claim 1 wherein the sensor is positioned on an inner wall of the stent.

4. The assembly according to claim 1 wherein the sensor is positioned within the stent.

5. The assembly according to claim 1 wherein the sensor is positioned on the luminal surface, adluminal surface, and/or implanted within a lumen.

6. The assembly according to any one of claims 1 to 4 wherein the sensor is a fluid pressure sensor.

7. The assembly according to any one of claims 1 to 4 wherein the sensor is a contact sensor.

8. The assembly according to any one of claims 1 to 4 wherein the sensor is a position sensor.

9. The assembly according to any one of claims 1 to 4 wherein the sensor is a pulse pressure sensor.

10. The assembly according to any one of claims 1 to 4 wherein the sensor is a blood volume sensor

11. The assembly according to any one of claims 1 to 4 wherein the sensor is a blood flow sensor.

12. The assembly according to any one of claims 1 to 4 wherein the sensor is a blood chemistry sensor.

13. The assembly according to any one of claims 1 to 4 wherein the sensor is a blood metabolic sensor.

14. The assembly according to any one of claims 1 to 4 wherein the sensor is a mechanical stress sensor, accelerometer or a temperature sensor.

15. The assembly according to any one of claims 1 to 14 wherein said stent is a vascular, gastrointestinal, pulmonary, head and neck, or genitourinary stent.

16. The assembly according to claim 15 wherein said vascular stent is a coronary stent, carotid stent, cerebral stent, vertebral stent, iliac stent, femoral stent, popliteal stent, or stent for the arteries of the lower extremities.

17. The assembly according to claim 15 wherein said gastrointestinal stent is an esophageal, duodenal, colonic, biliary or pancreatic stent.

18. The assembly according to claim 15 wherein said pulmonary stent is a stent that holds open the trachea, bronchi, bronchioles or alveoli.

19. The assembly according to claim 15 wherein said genitourinary stent is a ureteral stent, urethral stent, a prostatic stent, or a fallopian tube stent.

20. The assembly according to claim 15 wherein said head and neck stent is a sinus stent, a maxillary sinus stent, a frontal sinus stent, a lacrimal stent, a nasal stent, or a typanostomy tube.

21. The assembly according to any one of claims 1 to 20 wherein said stent is a biodegradable or partially biodegradable stent.

22. The assembly according to any one of claims 1 to 20 wherein said stent is a non-biodegradable stent.

23. The assembly according to any one of claims 1 to 22 wherein said sensor is a wireless sensor.

24. The assembly according to any one of claims 1 to 22 wherein said sensor is connected to a wireless microprocessor.

25. The assembly according to any one of claims 1 to 24 wherein a plurality of sensors are positioned on or within said stent.

26. The assembly according to any one of claims 1 to 25 wherein said stent comprises more than one type of sensor.

27. The assembly according to any one of claims 1 to 26 wherein said stent comprises one or more fluid pressure sensors, contact sensors, accelerometers, and position sensors.

28. The assembly according to any one of claims 1 to 27 wherein said sensor is a plurality of sensors which are positioned on or within said stent at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

29. The assembly according to any one of claims 1 to 27 wherein said sensor is a plurality of sensors which are positioned on or within said stent at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

30. The assembly according to any one of claims 1 to 29 wherein said sensor has a unique sensor identification number.

31. The assembly according to any one of claims 1 to 30 wherein said sensor is uniquely defined within a specific position on or within said stent.

32. The assembly according to any one of claims 1 to 31 wherein said stent is comprised of two or more sections.

33. The assembly according to claim 32 wherein sensors are positioned on each of said two or more sections.

34. The assembly according to claim 32 wherein said sensors can be utilized to detect proper connection or assembly of a complete stent.

50. An assembly according to any one of claims 1 to 49 wherein said stent is a drug-eluting stent.

51. An assembly according to any one of claims 1 to 50 wherein said stent is at least partially coated with one or more polymers.

52. Use of a stent or assembly according to any one of claims 1 to 51 to obtain a measurement of cardiac function.

53. Use according to claim 52 wherein said measurement of cardiac function is selected from the group consisting of cardiac output, stroke volume, ejection fraction, systolic and/or diastolic blood pressure, mean arterial pressure, systemic vascular resistance, and total peripheral resistance.

54. Use according to claim 52 or 53, wherein said measurement occurs at more than one time point.

55. Use according to any one of claims 52 to 54 wherein said measurement takes place over more than 1, 2, 3, 4, 5, 10, 15, or 30 days.

56. Use according to any one of claims 52 to 55 wherein said measurement takes place over more than 1, 2, 3, 4, 5, 6, or 12 months.

58. The method according to claim 57 wherein said stent is an assembly according to any one of claims 1 to 51.

67. The non-transitory computer readable storage medium according to any one of claims 63 to 66, wherein said stent is an assembly according to any one of claims 1 to 51.

79. The method according to any one of claims 75 to 78 wherein said assembly is an assembly according to claims 1 to 51.

84. The method according to any one of claims 81 to 83 wherein said stent is an assembly according to any one of claims 1 to 51.

85. A method for placing a stent within a subject, comprising a) implanting an assembly according to any one of claims 1 to 51, and b) detecting placement of the stent by detecting a sensor.

86. The method according to claim 85 wherein the stent comprises two or more sections, and wherein detection of said two or more sections can be determined by analysis of one or more sensors.

87. The method according to claim 85 or 86 wherein placement of the stent can be visualized by a two or three dimensional representation or image of the one or more sensors on said stent.

88. The method according to any one of claims 85 to 87, wherein said method comprises two stents which are implanted to overlap with each other.

89. The method according to anyone of claims 85 to 88 wherein said detecting placement of the stent allows determination of whether the stent is kinked or placed incorrectly.

35. An assembly comprising a stent and a sensor, wherein said sensor measures the cardiac output of a subject.

36. An assembly comprising a stent and a sensor, wherein said sensor measures the stroke volume of a subject.

37. An assembly comprising a stent and a sensor, wherein said sensor measures the ejection fraction of a subject.

38. An assembly comprising a stent and a sensor, wherein said sensor measures the systolic blood pressure of a subject.

39. An assembly comprising a stent and a sensor, wherein said sensor measures the diastolic blood pressure of a subject.

40. An assembly comprising a stent and a sensor, wherein said sensor measures the mean arterial pressure of a subject.

41. An assembly comprising a stent and a sensor, wherein said sensor measures the systemic vascular resistance of a subject.

42. An assembly comprising a stent and a sensor, wherein said sensor measures the total peripheral resistance of a subject.

43. An assembly comprising a stent and a sensor, wherein said sensor measures the temperature of a subject.

44. An assembly comprising a stent and a sensor, wherein said sensor measures the development of restenosis.

45. An assembly comprising a stent and a sensor, wherein said sensor measures a cardiac function.

46. An assembly comprising a stent and a sensor, wherein said sensor measures the development of a thrombus, atherosclerosis, tumor, inflammation, abscess or other space occupying lesion.

47. An assembly comprising a stent and a sensor, wherein said sensor measures the development of normal healing tissue on the luminal surface of the stent.

48. An assembly comprising a stent and a sensor, wherein said sensor measures the metabolic function including indicators of renal function.

49. An assembly comprising a stent and a sensor, wherein said sensor measures heart rhythm including conduction and rhythm abnormalities.

57. A method of monitoring a stent comprising:

transmitting a wireless electrical signal from a location outside the body to a location inside the body;

receiving the signal at a sensor positioned on a stent located inside the body;

powering the sensor using the received signal;

sensing data at the sensor; and

outputting the sensed data from the sensor to a receiving unit located outside of the body.

59. The method according to claim 57 or 58 wherein said receiving unit is a watch, writs band, cell phone or glasses.

60. The method according to any one of claims 57 to 59 wherein said receiving unit is located within a subject'"'"'s residence or office.

61. The method according to any one of claims 57 to 60 wherein said sensed data is provided to a health care provider.

62. The method according to any one of claims 57 to 61 wherein said sensed data is posted to one or more websites.

72. The method according to any one of claims 57 to 62, or storage medium according to any one of claims 63 to 71, wherein said data is analyzed.

73. The method or storage medium according to claim 72 wherein said data is plotted to enable visualization of change over time.

74. The method or storage medium according to claim 72 or 73 wherein said data is plotted to provide a three-dimensional image.

63. A non-transitory computer-readable storage medium whose stored contents configure a computing system to perform a method, the method comprising:

identifying a subject, the identified subject having at least one wireless stent, each wireless stent having one or more wireless sensors;

directing a wireless interrogation unit to collect sensor data from at least one of the respective one or more wireless sensors; and

receiving the collected sensor data.

64. The non-transitory computer-readable storage medium of claim 63 whose stored contents configure a computing system to perform a method, the method further comprising:

identifying a plurality of subjects, each identified subject having at least one wireless stent, each wireless stent having one or more wireless sensors;

directing a wireless interrogation unit associated with each identified subject to collect sensor data from at least one of the respective one or more wireless sensors;

receiving the collected sensor data; and

aggregating the collected sensor data.

65. The non-transitory computer-readable storage medium of claim 63 whose stored contents configure a computing system to perform a method, the method further comprising:

removing sensitive subject data from the collected sensor data; and

parsing the aggregated data according to a type of sensor.

66. The non-transitory computer-readable storage medium of claim 63 whose stored contents configure a computing system to perform a method, wherein directing the wireless interrogation unit includes directing a control unit associated with the wireless interrogation unit.

68. The storage medium according to any one of claims 63 to 67 wherein said collected sensor data is received on a watch, wrist band, cell phone or glasses.

69. The storage medium according to any one of claims 63 to 68 wherein said collected sensor data is received within a subject'"'"'s residence or office.

70. The storage medium according to any one of claims 63 to 69 wherein said collected sensed data is provided to a health care provider.

71. The storage medium according to any one of claims 63 to 70 wherein said sensed data is posted to one or more websites.

75. A method for determining degradation of a stent, comprising the steps of a) providing to a body passageway of a subject an assembly comprising a stent and one or more sensors, and b) detecting a change in a sensor, and thus determining degradation of the stent.

76. The method according to claim 75 wherein said sensor is capable of detecting one or more physiological and/or locational parameters.

77. The method according to claim 75 or 76 wherein said sensor detects contact, fluid flow, pressure and/or temperature.

78. The method according to any one of claims 75 to 77 wherein said sensor detects a location within the subject.

80. The method according to any one of claims 75 to 79 wherein the step of detecting is a series of detections over time.

81. A method for imaging a stent, comprising detecting the changes in sensors in, on, and or within a stent over time, and wherein the stent comprises sensors at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

83. The method according to claim 81 or 82, wherein said sensor is one or more of a fluid pressure sensor, contact sensor, position sensor, accelerometer, pressure sensor, blood volume sensor, blood flow sensor, blood chemistry sensor, blood metabolic sensor, mechanical stress sensor, and temperature sensor.

82. A method for imaging a stent, comprising detecting changes in sensors in, on, and or within a stent over time, and wherein the stent comprises sensors at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.