Medical systems and methods for density assessment using ultrasound

• US 10,595,818 B2
• Filed: 02/19/2017
• Issued: 03/24/2020
• Est. Priority Date: 03/19/2016
• Status: Active Grant

• Current Assignee: Makaha Medical, LLC
• Original Assignee: Makaha Medical, LLC
• Inventors: Levine, Marc-Alan
• Primary Examiner(s): Hoffa, Angela M
• Assistant Examiner(s): Patel, Virag B
• Application Number:
  US15/436,820
• Publication Number:
  US 20170265839A1
• Time in Patent Office: 1,129 Days
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00035 pH
• CPC Class Codes: A61B 2017/00106 ultrasonic
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/1126 using a particular sensing technique
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6851 Guide wires
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• 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 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4494 characterised by the arrangement of the transducer elements devices for short-range imaging using particular transducer elements arrangements under G01S15/8909; arrangements of transducers in generation of mechanical vibrations of infrasonic, sonic or ultrasonic frequency B06B1/0607
• CPC Class Codes: A61B 8/461 Displaying means of special interest
• CPC Class Codes: A61B 8/467 characterised by special input means
• CPC Class Codes: A61B 8/5223 : for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

A medical system and method for density assessment utilizing ultrasound. The system includes a guidewire configured and dimensioned for insertion in the vessel of the patient, a sensor positioned at the distal portion of the elongated member and a connector connecting the elongated member to an indicator, the sensor determining the density and the indicator providing an indication of the determined density.

Claims

1. A method for determining a state of blood clot removal from a vessel of a patient multiple times during a surgical procedure based on density assessment, the method comprising the steps of:

a) providing an elongated guidewire including a sensor;

b) inserting the guidewire through vasculature of the patient and adjacent a blood clot;

c) inserting a device to remove the blood clot, into a region along a length of the blood clot;

d) either before or after step (c), measuring density of the blood clot with the sensor to obtain a first density value utilizing ultrasound signals and determining a first length of the blood clot with the sensor utilizing ultrasound signals, wherein the ultrasound signals are sent from within the vessel;

e) after steps c) and d), using the device to remove at least a portion of the blood clot;

f) after step e measuring the density of the blood clot with the sensor utilizing ultrasound to obtain a second density value for comparison to the first density value to determine the extent of removal of the blood clot from the vessel;

g) using the sensor to ultrasonically determine a second length of the blood clot after step e) to determine a decrease in a length of the blood clot; and

h) simultaneously displaying the first density value, the second density value, the first length, and the second length.

2. The method of claim 1, wherein the steps of measuring to obtain the first density value and second density value and determining the first length and second length of the blood clot are performed using measurements of time between transmitted and reflected ultrasonic waves.

3. The method of claim 1, wherein the first density value and the second density value are numerals visually displayed on a display.

4. The method of claim 1, further comprising repeating steps e)-h) to provide real time assessment of blood clot removal.

5. The method of claim 1, further comprising an indicator for simultaneously displaying the first density value representative of an initial density and the second density value and a connector connecting the guidewire to the indicator.

6. The method of claim 1, further comprising the steps of measuring oxygen level of blood downstream of the blood clot and displaying on a display the measured oxygen level.

7. The method of claim 1, further comprising the step of measuring a pH level of the blood, wherein if the pH level is below a predetermined level, reducing the blood flow rate.

8. The method of claim 1, wherein the elongated guidewire includes a marker band and the sensor is positioned within the marker band.

9. The method of claim 1, wherein an indicator numerically displays the first density value representative of initial density and the first length representative of an initial length of the blood clot, the indicator further numerically displaying the second density value representative of a subsequent density of the blood clot and the second length representative of subsequent length of the blood clot, for comparison.

10. The method of claim 1, wherein at any time during removal of the blood clot the second density measuring can be activated to generate the ultrasound waves for measuring the second density by measuring the ultrasound signals transmitted and received.

11. The method of claim 1, wherein the step of inserting a device to remove the blood clot comprises inserting a mechanical thrombectomy device.

12. The method of claim 1, wherein the step of inserting a device to remove the blood clot comprises inserting a microcatheter and injecting cryogenic fluid.

13. A method for determining a state of blood clot removal from a vessel of a patient multiple times during a surgical procedure based on density assessment comprising the steps of:

a) providing an elongated guidewire including a pH sensor and density sensor;

b) inserting the elongated guidewire through vasculature of the patient and adjacent a blood clot, into a region along a length of the blood clot,

c) inserting a device to remove the blood clot, into a region along a length of the blood clot;

d) either before or after step (c), measuring density of the blood clot with the density sensor to obtain a first density value utilizing ultrasound signals, wherein the ultrasound signals are sent from within the vessel;

e) after steps c) and d), using the device to remove at least a portion of the blood clot;

f) after step e) measuring the density of the blood clot with the density sensor utilizing ultrasound to obtain a second density value for comparison to the first density value to determine the extent of removal of the blood clot from the vessel;

g) simultaneously displaying the first density value and the second density value; and

h) measuring pH level of the blood with the pH sensor and indicating to a user the pH level of the blood to enable the user to determine a pH level of the vessel downstream of the blood clot for;

(i) a determination of a clot treatment approach to remove the blood clot; and

(ii) a determination whether slow reperfusion during and/or after removal of the blood clot is warranted.

14. The method of claim 13, further comprising the steps of determining based on the pH level of the blood whether slow reperfusion during removal of the blood clot is warranted and inflating a balloon prior to removal of the blood clot to slow reperfusion if determination is made that slow reperfusion is warranted.

15. The method of claim 13, wherein during removal of the blood clot, a first length and a second length of the blood clot are tracked to detect reduced length.

16. The method of claim 15, wherein an indicator numerically simultaneously displays the first density value representative of initial density and the first length representative of an initial length of the blood clot, the indicator further numerically displaying the second density value representative of a subsequent density of the blood clot and the second length representative of subsequent length of the blood clot comparison.

17. The method of claim 13, further comprising the steps of measuring oxygen level of blood downstream of the blood clot and displaying on a display the measured oxygen level.

18. The method of claim 13, wherein if the pH level is below a predetermined level, reducing the blood flow rate.

19. The method of claim 13, wherein the guidewire includes a marker band and the density sensor for measuring density is positioned within the marker band.