Catheter or guidewire device including flow sensing and use thereof

• US 9,801,557 B2
• Filed: 02/18/2016
• Issued: 10/31/2017
• 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, Jr., John A., Klinker, Lauren
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US15/047,314
• Publication Number:
  US 20160213262A1
• Time in Patent Office: 621 Days
• 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.