CATHETER OR GUIDEWIRE DEVICE INCLUDING FLOW SENSING AND USE THEREOF

• US 20140249520A1
• Filed: 01/03/2014
• Published: 09/04/2014
• Est. Priority Date: 07/05/2012
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: MC10, Inc.
• Inventors: GHAFFARI, ROOZBEH, LEE, STEPHEN, WORK, JOHN, WRIGHT, JOHN, KLINKER, LAUREN
• Granted Patent: US 9,295,842 B2
• Time in Patent Office: Days
• US Class Current: 606/34
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00088 using thermistors
• CPC Class Codes: A61B 2017/00092 using thermocouples
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00386 Coronary vessels
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00672 : lower
• CPC Class Codes: A61B 2018/00678 : upper
• CPC Class Codes: A61B 2018/00708 : switching the power on or off
• CPC Class Codes: A61B 2018/00744 : Fluid flow
• CPC Class Codes: A61B 2018/00791 : Temperature
• CPC Class Codes: A61B 2018/00797 : measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/00815 : measured by a thermistor
• CPC Class Codes: A61B 2018/00821 : measured by a thermocouple
• CPC Class Codes: A61B 2018/00839 : Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00863 : Fluid flow
• CPC Class Codes: A61B 2018/00875 : Resistance or impedance
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/1861 : with an instrument inserted into a body lumen or cavity, e.g. a catheter
• CPC Class Codes: A61B 2018/20361 : with redirecting based on sensed condition, e.g. tissue analysis or tissue movement
• CPC Class Codes: A61B 2018/205547 : Controller with specific architecture or programmatic algorithm for directing scan path, spot size or shape, or spot intensity, fluence or irradiance
• CPC Class Codes: A61B 2034/252 : indicating steps of a surgical procedure
• CPC Class Codes: A61B 2034/254 : being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2090/065 : for measuring contact or contact pressure
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 34/35 : for telesurgery
• CPC Class Codes: A61B 5/027 : using catheters
• CPC Class Codes: A61B 5/6851 : Guide wires
• CPC Class Codes: A61B 90/30 : Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61B 90/70 : Cleaning devices specially adapted for surgical instruments
• CPC Class Codes: A61N 1/0514 : Electrodes for the urinary tract
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Devices and methods are provided for performing procedure on tissue with flow monitoring using flow sensors. The devices include an elongated member, and at least one flow sensor disposed on the elongated member. The flow sensor includes at least one temperature sensor and at least one heating element having a cavity. At least a portion of the at least one temperature sensor is housed in the cavity. A temperature measurement of the temperature sensor provides an indication of the flow rate of a fluid proximate to the flow sensor.

Claims

1. A device for determining a flow rate of a fluid proximate to a portion of a tissue, comprising:

an elongated member having a proximal portion and a distal portion;

a flow sensor disposed proximate to the distal portion of the elongated member, the flow sensor comprising;

at least one temperature sensor; and

at least one heating element to heat an area proximate to the elongated member, at least a portion of the at least one heating element forming a cavity, wherein;

at least a portion of the at least one temperature sensor is housed in a portion of the cavity; and

a temperature measurement of the temperature sensor provides a first indication of a flow rate of the fluid proximate to the flow sensor.

2. The device of claim 1, further comprising an inflatable and/or expandable body coupled to a portion of the elongated member and having a proximal portion and a distal portion, wherein the distal portion of the inflatable and/or expandable body is disposed proximate to the flow sensor.

3. The device of claim 2, further comprising an electronic circuit coupled with the inflatable and/or expandable body, wherein the electronic circuit comprises at least one stretchable interconnect, and wherein the electronic circuit is stretchable and conformable such that the electronic circuit accommodates an expansion of the inflatable and/or expandable body.

4. The device of claim 3, wherein the electronic circuit further comprises at least one passive electronic component and/or at least one active electronic component, and wherein the at least one stretchable interconnect electrically couples at least two electronic components of the electronic circuit.

5. The device of claim 3, wherein the electronic circuit further comprises a plurality of electrodes, and wherein at least one electrode of the plurality of electrodes is a radiofrequency electrode to deliver a radiofrequency energy to a surface proximate to the radiofrequency electrode.

6. The device of claim 3, wherein the electronic circuit comprises at least one ablative element.

7. The device of claim 1, wherein the device is adapted for performing a procedure on the portion of tissue, and wherein the procedure is a denervation procedure or a nerve stimulation procedure.

8. The device of claim 7, wherein the procedure is a carotid sinus denervation, a carotid body disruption, a vagus nerve stimulation, a pulmonary artery denervation, a celiac ganglion disruption, a bladder trigone ablation, or a renal denervation.

9. The device of claim 1, wherein the temperature sensor is a thermistor or a thermocouple.

10. The device of claim 1, wherein the elongated member is a catheter or a guide wire.

11. The device of claim 1, further comprising a reference temperature sensor disposed on a proximal portion of the elongated member.

12. The device of claim 11, wherein a comparison of a temperature measurement of the reference temperature sensor to a measurement of the flow sensor provides a second indication of a flow rate of the fluid.

13. The device of claim 1, wherein the at least one flow sensor is a plurality of flow sensors.

14. The device of claim 1, wherein the fluid is blood, and wherein the first indication of the flow rate of the fluid is indicative of a hemodynamic property of the fluid.

15. The device of claim 1, further comprising at least one component adapted to perform an ablative procedure.

16. The device of claim 15, further comprising at least one pacing electrode disposed on the inflatable and/or expandable body to deliver an electrical stimulation to a portion of the tissue proximate to the pacing electrode.

17. The device of claim 16, wherein the electrical stimulation is applied to the portion of the tissue prior to performing the ablation procedure.

18. The device of claim 1, wherein the operation of the heating element and the temperature sensor are coupled to provide a measure of a change in temperature caused by a change in the flow rate of the fluid.

19. The device of claim 1, wherein the flow sensor is encapsulated in a thermally-conductive encapsulant.

20. The device of claim 1, wherein the at least one heating element comprises a coiled resistive wire, and wherein a hollow portion of the coiled resistive wire forms the cavity.

21. The device of claim 1, wherein the at least one heating element comprises a thin-film patterned resistive element, and wherein the at least one heating element is formed in a substantially cylindrical conformation including the cavity.

22. The device of claim 21, wherein the thin-film patterned resistive element comprises a pattern of resistive elements disposed on a stretchable and/or flexible substrate.

23. The device of claim 22, wherein the resistive elements are formed in a linear pattern, a serpentine pattern, a boustrophedonic pattern, a zig-zag pattern, a wavy pattern, a polygonal pattern, or a substantially circular pattern.

24. An apparatus for displaying representations of parameters of an inflatable body and/or expandable body disposed proximate to a portion of a tissue, the inflatable body and/or expandable body comprising a plurality of sensors coupled to at least a portion of the inflatable body and/or expandable body, the apparatus comprising:

a user interface;

at least one memory to store processor-executable instructions; and

at least one processing unit communicatively coupled to the at least one memory, wherein, upon execution of the processor-executable instructions, the at least one processing unit;

controls the user interface to display at least one representation of the parameters, the at least one representation comprising;

(A) a first representation of a state of the inflatable body and/or expandable body, the first representation comprising;

(i) a first form indicator to indicate that the inflatable body and/or expandable body is in an inflated and/or an expanded state;

or

(ii) a second form indicator to indicate that the inflatable body and/or expandable body is in a deflated and/or a collapsed state; and

(B) a second representation of a state of at least one sensor of the plurality of sensors, the second representation comprising;

(i) a first activation indicator to indicate that the at least one sensor of the plurality of sensors measures a signal below a threshold value;

or

(ii) a second activation indicator to indicate that the at least one sensor of the plurality of sensors measures a signal above or about equal to the threshold value.

25. The apparatus of claim 24, wherein the signal below the threshold value indicates that the at least one sensor is not in contact with a portion of the tissue, and wherein the signal above or about equal to the threshold value indicates that the at least one sensor is in contact with a portion of the tissue.

26. The apparatus of claim 24, wherein the first activation indicator and the second activation indicator are displayed as binary visual representations.

27. The apparatus of claim 24, wherein the first activation indicator and the second activation indicator are displayed as quantitative visual representations that correspond to a magnitude of the signal.

28. The apparatus of claim 24, wherein the first form indicator and the second form indicator are displayed as color-coded symbols, where each color-coded symbol is indicative of a range of values of the magnitudes of the signal.

29. The apparatus of claim 24, wherein the first form indicator and the second form indicator further provide an indication of a spatial location of the corresponding at least one sensor relative to the inflatable body and/or expandable body.

30. The apparatus of claim 24, wherein, upon execution of the processor-executable instructions, the at least one processing unit controls the user interface to cause display of the first representation and the second representation in a staged process, such that:

no second representation is displayed while the first representation is the first form indicator; and

the second representation is displayed once the first representation is the second form indicator.

31. The apparatus of claim 24, wherein, upon execution of the processor-executable instructions, the at least one processing unit controls the user interface to further cause display of an indication of at least one stage of a procedure being performed on the portion of the tissue.

32. The apparatus of claim 24, wherein, upon execution of the processor-executable instructions, the at least one processing unit controls the user interface to cause display of an indication of an endpoint of a procedure being performed on the portion of the tissue.

33. The apparatus of claim 24, wherein the second representation is indicative of a magnitude of an instantaneous velocity, a volumetric flow, or a vascular resistance.

34. A method of performing a medical treatment procedure on a tissue, the method comprising:

disposing in proximity to the tissue an apparatus comprising;

an elongated member having a proximal portion and a distal portion;

at least one flow sensor disposed proximate to the distal portion of the elongated member, each of the at least one flow sensor comprising;

at least one temperature sensor; and

at least one heating element disposed proximate to the at least one temperature sensor;

a reference temperature sensor disposed on a proximal portion of the elongated member; and

a control module coupled to the at least one flow sensor and the reference temperature sensor;

using the control module to maintain a temperature difference between the reference temperature sensor and the temperature sensor of the at least one flow sensor at a stage of performance of the medical treatment procedure, comprising;

monitoring a value of a temperature measurement of the reference temperature sensor and/or a temperature measurement of the temperature sensor of the at least one flow sensor;

controlling a first signal to the at least one heating element to cause the at least one heating element to emit heat or discontinue emitting heat, such that that the temperature difference is maintained.

35. The method of claim 34, wherein the temperature difference is a constant temperature difference or a time-varying temperature difference.

36. The method of claim 35, wherein the temperature difference is a constant temperature difference, and wherein the constant temperature difference is about 1.5°

C., about 2.0°

C., about 2.5°

C., about 3.0°

C., about 3.5°

C., about 4.0°

C., or about 4.5°

C.

37. The method of claim 34, wherein the control module comprises a proportional-integral-derivative (PID) controller or an anemometer.

38. The method of claim 37, wherein the control module comprises a PID controller, the method further comprising:

applying the PID controller to;

compare the value of the temperature measurement of the reference temperature sensor to the temperature measurement of the temperature sensor of at least one flow sensor; and

determine a second signal based on the comparison;

using the control module to determine the first signal to the at least one heating element based on the second signal.

39. The method of claim 34, wherein the apparatus further comprises at least one component to perform an ablation procedure on a portion of the tissue.

40. The method of claim 39, further comprising:

applying the ablation procedure to the portion of the tissue;

using the control module to monitor a temperature measurement of the temperature sensor of at least one flow sensor, thereby monitoring a flow rate of a fluid proximate to the portion of tissue; and

using the control module to control the first signal to the at least one heating element to cause the at least one heating element to emit heat or discontinue emitting heat, such that that the temperature difference is maintained.

41. The method of claim 34, further comprising recording the first signal to the at least one heating element.

42. The method of claim 34, wherein the first signal to the at least one heating element is a time-varying voltage signal.

43. The method of claim 34, wherein at least a portion of the at least one heating element forms a cavity, and wherein at least a portion of the at least one temperature sensor is housed in a portion of the cavity.

44. The method of claim 34, wherein the medical treatment procedure comprises a denervation procedure or a nerve stimulation procedure.

45. The method of claim 34, wherein the medical treatment procedure is a carotid sinus denervation, a carotid body disruption, a vagus nerve stimulation, a pulmonary artery denervation, a celiac ganglion disruption, a bladder trigone ablation, or a renal denervation.

46. The method of claim 34, wherein the temperature sensor is a thermistor or a thermocouple.

47. The method of claim 34, wherein the elongated member is a catheter or a guide wire.

48. The method of claim 34, wherein the at least one flow sensor is a plurality of flow sensors.

49. A method of determining an efficacy of a medical treatment procedure performed on a tissue, the method comprising:

A) disposing in proximity to the tissue an apparatus comprising;

an elongated member having a proximal portion and a distal portion;

at least one flow sensor disposed proximate to the distal portion of the elongated member, and

at least one component coupled to the elongated member to perform a treatment procedure on a portion of the tissue proximate to the elongated member;

B) activating the at least one component to perform the treatment procedure on the portion of the tissue;

C) using the at least one flow sensor to perform at least one flow measurement, the at least one flow measurement providing data indicative of a change in the flow subsequent to the treatment procedure of a fluid proximate to the apparatus;

D) analyzing the data indicative of the flow of the fluid to determine at least one time-constant associated with the data; and

E) comparing the at least one time-constant associated with the data to a time-constant indicative of the flow of the fluid prior to performance of the treatment procedure,

wherein a difference provides an indication of the efficacy of the treatment procedure.

50. The method of claim 49, wherein (B), (C), (D) and (E) are repeated until the difference falls in a specified range of values.

51. The method of claim 50, further comprising generating an indication of an endpoint of the treatment procedure when the difference falling in the specified range of values.

52. The method of claim 51, further comprising displaying the indication of the endpoint of the treatment procedure on a display.

53. The method of claim 49, wherein the medical treatment procedure is a carotid sinus denervation, a carotid body disruption, a vagus nerve stimulation, a pulmonary artery denervation, a celiac ganglion disruption, a bladder trigone ablation, or a renal denervation.

54. The method of claim 49, wherein the time constant provides a measure of the rate of change in the flow from a highest value following the treatment procedure to a steady-state value at a later time.

55. The method of claim 49, further comprising determining a first order rate of change with time of the at least one time constant and/or a second order rate of change with time of the at least one time constant.

56. The method of claim 55, further comprising comparing the first order rate of change with time of the at least one time constant to a standard for the first order rate of change, wherein the comparison provides a second indication of the efficacy of the medical treatment procedure.

57. The method of claim 55, further comprising comparing the second order rate of change with time of the at least one time constant to a standard for the second order rate of change, wherein the comparison provides a third indication of the efficacy of the medical treatment procedure.

58. The method of claim 49, wherein the at least one component is an ablative component, and wherein the medical treatment procedure is a denervation procedure.

59. A method of monitoring a hemodynamic effect during a medical treatment procedure performed on a vascular tissue, the method comprising:

A) disposing in proximity to the tissue an apparatus comprising;

an elongated member having a proximal portion and a distal portion;

at least one flow sensor disposed proximate to the distal portion of the elongated member, and

at least one component coupled to the elongated member to perform a medical treatment procedure on a portion of the tissue proximate to the elongated member;

B) activating the at least one component to perform the medical treatment procedure on the portion of the tissue;

C) administering a substance that causes a change in dimension of the vascular tissue;

D) using the at least one flow sensor to perform at least one flow measurement, the at least one flow measurement providing data indicative of a change in the flow subsequent to the medical treatment procedure of a fluid proximate to the apparatus;

E) analyzing the data indicative of the flow of the fluid to determine at least one parameter indicative of the change in the hemodynamics of the fluid,

wherein a reduction in the change in the hemodynamics of the fluid provides an indication of the efficacy of the medical treatment procedure.

60. The method of claim 59, wherein (B), (C), (D) and (E) are repeated until the rate of reduction of the change in the hemodynamics of the fluid falls below a specified value.

61. The method of claim 60, further comprising generating an indication of an endpoint of the medical treatment procedure when the rate of reduction of the change in the hemodynamics of the fluid falls below the specified value.

62. The method of claim 61, further comprising displaying the indication of the endpoint of the medical treatment procedure on a display.

63. The method of claim 59, wherein the substance comprises an endogenous substance or an exogenous substance.

64. The method of claim 63, wherein the substance comprises a calcium channel blocker, a cAMP-mediated stimulant, or a nitrovasodilator.

65. The method of claim 63, wherein the substance comprises a dopamine, adenosine, prostacyclin, saline, or nitric oxide.

66. The method of claim 59, wherein the substance comprises a vasodilation substance or a vasoconstriction substance.

67. The method of claim 59, wherein the at least one component is an ablative component, and wherein the medical treatment procedure is a denervation procedure.

68. The method of claim 59, wherein the elongated member comprises an inflatable and/or expandable body, and wherein the inflatable and/or expandable body is disposed proximate to the distal portion of the elongated member.

69. The method of claim 68, wherein the inflatable and/or expandable body is a balloon, an expandable spiral coil, an expandable mesh, or a deployable netting.

70. The method of claim 68, wherein the inflatable and/or expandable body comprises an electronic circuit coupled with a portion of the inflatable and/or expandable body, wherein the electronic circuit comprises at least one stretchable interconnect, and wherein the electronic circuit is stretchable and conformable such that the electronic circuit accommodates an expansion of the inflatable and/or expandable body.