MULTIFUNCTIONAL GUIDEWIRE ASSEMBLIES AND SYSTEM FOR ANALYZING ANATOMICAL AND FUNCTIONAL PARAMETERS

• US 20140142398A1
• Filed: 11/12/2013
• Published: 05/22/2014
• Est. Priority Date: 06/13/2010
• Status: Abandoned Application

• Current Assignee: Angiometrix Corporation
• Original Assignee: Angiometrix Corporation
• Inventors: PATIL, Nitin, SUBRAMANIYAN, Raghavan, DUTTA, Goutam
• Application Number:
  US14/078,237
• Publication Number:
  US 20140142398A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/463 characterised by displaying multiple images or images and diagnostic data on one display
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61B 6/5241 combining overlapping images of the same imaging modality, e.g. by stitching
• CPC Class Codes: A61B 6/5288 involving retrospective matching to a physiological signal
• CPC Class Codes: A61B 6/541 involving acquisition triggered by a physiological signal
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/463 characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/565 involving data transmission via a network
• CPC Class Codes: A61B 8/582 Remote testing of the device
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices

Abstract

Multifunctional guidewire assemblies and system for analyzing anatomical and functional parameters are described. Using a single guidewire assembly, functional and anatomical measurements and identification of lesions may be made. Functional measurements such as pressure may be obtained with a pressure sensor on the guidewire while anatomical measurements such as luminal dimensions may be obtained by utilizing an electrode assembly along the guidewire. The vascular network and stenosed lesions may be modeled into an equivalent electrical network and solved based on the measured parameters to obtain unknown parameters of the electrical network. Several treatment plan options may be constructed where each plan may correspond to the treatment of a subset of particular lesions. The anatomical outcome for each of the treatment plans may be estimated and the equivalent modified electrical parameters may be determined. Then, each of the electrical networks for each plan may be solved to determine the functional outcome for each treatment plan and the outcomes for all treatment plans may be presented to a physician.

Claims

1. A guidewire device configured to assess one or more vascular bodily lumens, comprising:

an elongate guidewire body;

a pressure sensor positioned near or at a distal end of the guidewire body; and

,

a plurality of excitation elements and a plurality of sensing elements disposed on the guidewire body in proximity to the pressure sensor.

2. The device of claim 1 wherein a first of the plurality of sensing elements is not equally spaced from second and third sensing elements.

3. The device of claim 1 further comprising a processor secured within or along the guidewire body and in electrical communication with the pressure sensor.

4. The device of claim 3 wherein the processor comprises an ASIC component formed along the substrate and in electrical communication with the diaphragm.

5. The device of claim 3 wherein the processor comprises a switch that is in communication with the pressure sensor and the plurality of electrodes.

6. The device of claim 1 wherein the guidewire body comprises a structure having at least a distal coil.

7. The device of claim 1 wherein the pressure sensor comprises a housing which defines a slot therealong.

8. The device of claim 7 further comprising a substrate secured within the housing, the substrate having a diaphragm exposed through the slot defined by the housing.

9. The device of claim 3 wherein the processor is positioned within the guidewire body proximal to the pressure sensor.

10. The device of claim 3 wherein the processor is in electrical communication with the guidewire body.

11. The device of claim 10 wherein the pressure sensor is in electrical communication with the guidewire body.

12. The device of claim 1 wherein the plurality of excitation elements and sensing elements are positioned proximal to the pressure sensor along the guidewire body

13. The device of claim 1 wherein the plurality of excitation elements and sensing elements are coupled to a processor configured to sense a luminal diameter.

14. The device of claim 3 wherein the processor is configured for wireless transmission of information.

15. The device of claim 1 wherein a first sensing element is disposed axially between the second and third sensing elements on the guidewire body.

16. The device of claim 15 wherein the second and third sensing elements are also first and second excitation elements.

17. The device of claim 1 wherein the excitation elements and sensing elements are electrodes.

18. The device of claim 1 further comprising an external power source in wireless communication with the processor and/or pressure sensor.

19. The device of claim 1 wherein the plurality of excitation elements are in communication with a processor which is programmed to generate a multiple-frequency electrical signal at a plurality of frequencies through the excitation elements.

20. The device of claim 19 wherein the processor is further programmed to measure an electrical signal from the plurality of sensing elements from at least two of the frequencies in response to a delivered signal.

21. The device of claim 20 wherein the processor is further programmed to determine a lumen dimension using the measured electrical signal at the at least two frequencies.

22. A method of treating one or more vascular bodily lumens, comprising:

intravascularly positioning an elongate device within the one or more vascular bodily lumens in proximity to at least one lesion;

determining a pressure in proximity to and distal to the at least one lesion via a pressure sensor positioned along the elongate device;

determining a lumen dimension in proximity to and through the at least one lesion via a lumen dimension measurement device positioned along the elongate device;

modeling the one or more vascular bodily lumens and the at least one lesion into a corresponding electrical network;

solving the electrical network using the pressure and lumen dimension measured via the elongate device; and

,

developing one or more treatment plans corresponding to a treatment of one or more particular lesions.

23. The method of claim 22 wherein the elongate device comprises a guidewire.

24. The method of claim 22 wherein determining a pressure comprises sensing the pressure via a diaphragm exposed near or at a distal end of the elongate device.

25. The method of claim 24 further comprising determining the pressure via a processor positioned within the elongate device and in electrical communication with the pressure sensor.

26. The method of claim 22 wherein determining a lumen dimension comprises determining the dimension via an IVUS sensor.

27. The method of claim 22 wherein determining a lumen dimension comprises determining the dimension via an OCT sensor.

28. The method of claim 22 wherein determining a lumen dimension comprises:

generating a multiple-frequency electrical signal at a plurality of frequencies;

delivering the multiple frequency electrical signal to the electrode assembly in the vicinity of the vascular bodily lumen;

measuring an electrical signal from a plurality of sensing elements at least two of the plurality of frequencies in response to the delivered signal; and

,

determining the lumen dimension using the measured electrical signal at the at least two frequencies.

29. The method of claim 28 wherein measuring an electrical signal comprises measuring voltages across the plurality of sensing elements at the at least two of the plurality of frequencies.

30. The method of claim 28 wherein measuring an electrical signal comprises measuring voltages across the plurality of sensing elements at each of the plurality of frequencies.

31. The method of claim 30 wherein determining the lumen dimension comprises converting the voltages to one or more lumen dimensions.

32. The method of claim 31 wherein determining a lumen dimension comprises determining a lumen cross sectional area using the electrical signal at least two of the plurality of frequencies.

33. The method of claim 28 wherein the measuring step comprises measuring the electrical signals at the at least two frequencies simultaneously.

34. The method of claim 22 wherein modeling comprises modeling the pressure from the vascular bodily lumen as voltage in the corresponding electrical network.

35. The method of claim 34 further comprising modeling a fluid resistance through the at least one lesion as electrical resistance in the corresponding electrical network.

36. The method of claim 35 wherein modeling the fluid resistance comprises correlating the fluid resistance to the lumen dimension across the at least one lesion.

37. The method of claim 34 further comprising modeling a blood flow through the vascular bodily lumen as electrical current in the corresponding electrical network.

38. The method of claim 37 wherein modeling the blood flow comprises correlating the blood flow to a pressure drop across the vascular bodily lumen.

39. The method of claim 34 further comprising modeling a resistance of vasculature distal to the at least one lesion.

40. The method of claim 22 wherein solving the electrical network comprises solving for a resistance of vasculature distal to the at least one lesion.

41. The method of claim 40 further comprising solving for a blood flow through the vascular bodily lumen.

42. The method of claim 22 wherein developing one or more treatment plans comprises varying one or more resistance values correlating to a treatment of the one or more particular lesions.

43. The method of claim 42 further comprising determining a correlating blood flow through the vascular bodily lumen as a result of varying the one or more resistance values.

44. A method of treating one or more vascular bodily lumens, comprising:

intravascularly positioning an elongate device within the one or more vascular bodily lumens in proximity to at least one lesion;

determining a pressure in proximity to and distal to at least one lesion via a pressure sensor positioned along the elongate device;

determining a lumen dimension in proximity to and through the at least one lesion via a lumen dimension measurement device positioned along the elongate device;

developing one or more treatment plans corresponding to a treatment of one or more particular lesions using measured pressure and lumen dimensions;

determining a functional outcome of each of the one or more treatment plans; and

,

selecting an optimal treatment plan based on the determined functional outcome of one or more treatment plans.

45. The method of claim 44 wherein determining a pressure comprises sensing the pressure via a diaphragm exposed near or at a distal end of the elongate device.

46. The method of claim 45 further comprising determining the pressure via a processor positioned within the elongate device and in electrical communication with the pressure sensor.

47. The method of claim 44 wherein determining a lumen dimension comprises:

generating a multiple-frequency electrical signal at a plurality of frequencies;

delivering the multiple frequency electrical signal to the electrode assembly in the vicinity of the vascular bodily lumen;

measuring an electrical signal from a plurality of sensing elements at least two of the plurality of frequencies in response to the delivered signal; and

,

determining the lumen dimension using the measured electrical signal at the at least two frequencies.

48. The method of claim 47 wherein measuring an electrical signal comprises measuring voltages across the plurality of sensing elements at the at least two of the plurality of frequencies.

49. The method of claim 47 wherein measuring an electrical signal comprises measuring voltages across the plurality of sensing elements at each of the plurality of frequencies.

50. The method of claim 49 wherein determining the lumen dimension comprises converting the voltages to one or more lumen dimensions.

51. The method of claim 50 wherein determining a lumen dimension comprises determining a lumen cross sectional area using the electrical signal at least two of the plurality of frequencies.

52. The method of claim 47 wherein the measuring step comprises measuring the electrical signals at the at least two frequencies simultaneously.

53. The method of claim 44 wherein developing one or more treatment plans comprises modeling the one or more vascular bodily lumens and the at least one lesion into a corresponding electrical network.

54. The method of claim 53 further comprising modeling a fluid resistance through the at least one lesion as electrical resistance in the corresponding electrical network.

55. The method of claim 54 wherein modeling the fluid resistance comprises correlating the fluid resistance to the lumen dimension across the at least one lesion.

56. The method of claim 53 further comprising modeling a blood flow through the vascular bodily lumen as electrical current in the corresponding electrical network.

57. The method of claim 47 wherein modeling the blood flow comprises correlating the blood flow to a pressure drop across the vascular bodily lumen.

58. The method of claim 53 further comprising modeling a resistance of vasculature distal to the at least one lesion.

59. The method of claim 53 further comprising solving the electrical network comprises solving for a resistance of vasculature distal to the at least one lesion.

60. The method of claim 44 wherein determining a functional outcome comprises determining a correlating blood flow through the vascular bodily lumen.

61. The method of claim 44 wherein selecting an optimal treatment plan comprises selecting a treatment plan based on a risk-reward trade-off.

62. A method of treating one or more vascular bodily lumens, comprising:

determining a lumen dimension of at least one lesion via a lumen dimension measuring system;

intravascularly positioning an elongate device within the one or more vascular bodily lumens in proximity to at least one lesion;

determining a pressure in proximity to and distal to the at least one lesion via a pressure sensor positioned along the elongate device;

modeling the one or more vascular bodily lumens and the at least one lesion into a corresponding electrical network;

solving the electrical network using the pressure and lumen dimension measured via the elongate device; and

,

developing one or more treatment plans corresponding to a treatment of one or more particular lesions.

63. The method of claim 62 wherein the lumen dimension measuring system is selected from the group consisting of X-ray, MRI, CT, Quantitative Coronary Angiography (QCA) and combinations thereof.

64. The method of claim 62 wherein determining a pressure comprises sensing the pressure via a diaphragm exposed near or at a distal end of the elongate device.

65. The method of claim 64 further comprising determining the pressure via a processor positioned within the elongate device and in electrical communication with the pressure sensor.

66. The method of claim 62 wherein determining a lumen dimension comprises:

generating a multiple-frequency electrical signal at a plurality of frequencies;

delivering the multiple frequency electrical signal to the electrode assembly in the vicinity of the vascular bodily lumen;

measuring an electrical signal from a plurality of sensing elements at least two of the plurality of frequencies in response to the delivered signal; and

,

determining the lumen dimension using the measured electrical signal at the at least two frequencies.

67. The method of claim 66 wherein measuring an electrical signal comprises measuring voltages across the plurality of sensing elements at the at least two of the plurality of frequencies.

68. The method of claim 66 wherein measuring an electrical signal comprises measuring voltages across the plurality of sensing elements at each of the plurality of frequencies.

69. The method of claim 68 wherein determining the lumen dimension comprises converting the voltages to one or more lumen dimensions.

70. The method of claim 69 wherein determining a lumen dimension comprises determining a lumen cross sectional area using the electrical signal at least two of the plurality of frequencies.

71. The method of claim 66 wherein the measuring step comprises measuring the electrical signals at the at least two frequencies simultaneously.

72. The method of claim 62 wherein developing one or more treatment plans comprises modeling the one or more vascular bodily lumens and the at least one lesion into a corresponding electrical network.

73. The method of claim 72 further comprising modeling a fluid resistance through the at least one lesion as electrical resistance in the corresponding electrical network.

74. The method of claim 73 wherein modeling the fluid resistance comprises correlating the fluid resistance to the lumen dimension across the at least one lesion.

75. The method of claim 72 further comprising modeling a blood flow through the vascular bodily lumen as electrical current in the corresponding electrical network.

76. The method of claim 75 wherein modeling the blood flow comprises correlating the blood flow to a pressure drop across the vascular bodily lumen.

77. The method of claim 72 further comprising modeling a resistance of vasculature distal to the at least one lesion.

78. The method of claim 72 further comprising solving the electrical network comprises solving for a resistance of vasculature distal to the at least one lesion.

79. The method of claim 62 further comprising selecting an optimal treatment plan from the one or more treatment plans based on a risk-reward trade-off.

80. A guidewire assembly, comprising:

an elongate guidewire body;

a pressure sensor secured near or at a distal end of the guidewire body; and

,

a processor secured within or along the guidewire body and in electrical communication with the pressure sensor.

81. The assembly of claim 80 wherein the processor comprises an ASIC component formed along the substrate and in electrical communication with the diaphragm.

82. The assembly of claim 80 wherein the processor comprises an ASIC component in electrical communication with the pressure sensor.

83. The assembly of claim 80 wherein the processor is positioned within the guidewire body proximal to the pressure sensor.

84. An elongate device configured to measure intravascular pressure and lumen dimensions, comprising:

a pressure sensor positioned at or along the distal end where the pressure sensor is configured to measure intravascular pressure;

a lumen dimension measurement device positioned in proximity to the pressure sensor and where the lumen dimension measurement device is configured to measure lumen dimensions,

wherein the said pressure sensor and the said lumen dimension measurement device are in communication with a processor which is programmed to use the measured pressure and lumen dimension information and provide a treatment plan.

85. The device of claim 84 wherein the elongate device comprises a guidewire.

86. The device of claim 84 wherein the lumen dimension measurement device comprises an IVUS sensor.

87. The device of claim 84 wherein the lumen dimension measurement device comprises an OCT sensor.

88. The device of claim 84 wherein the lumen dimension measurement device comprises a plurality of excitation elements and a plurality of sensing elements disposed on the elongate device in proximity to the pressure sensor.

89. The device of claim 88 wherein the elongate device comprises a guidewire.

90. The device of claim 88 wherein the plurality of excitation elements are in communication with a processor which is programmed to generate a multiple-frequency electrical signal at a plurality of frequencies through the excitation elements.

91. The device of claim 90 wherein the processor is further programmed to measure an electrical signal from the plurality of sensing elements from at least two of the frequencies in response to a delivered signal.

92. The device of claim 91 wherein the processor is further programmed to determine a lumen dimension using the measured electrical signal at the at least two frequencies.