Systems and methods for assessing vasculature health and blood clots

• US 9,700,215 B2
• Filed: 10/12/2013
• Issued: 07/11/2017
• Est. Priority Date: 10/24/2012
• Status: Active Grant

• Current Assignee: Makaha Medical, LLC
• Original Assignee: Makaha Medical, LLC
• Inventors: Levine, Marc-Alan
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): BALDWIN, NATHAN AARON
• Application Number:
  US14/052,721
• Publication Number:
  US 20140114144A1
• Time in Patent Office: 1,368 Days
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• 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 5/14551 for measuring blood gases
• 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 8/485 involving measuring strain or elastic properties
• 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 system and method for determining a pH level of blood in a vessel of a patient including a flexible elongated member 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 measures the pH level of blood downstream of the blood clot. A system and method are also provided for determining a density of a blood clot in a vessel of a patient for subsequent selection of a treatment method. The system includes a sensor positioned at the distal portion of the elongated member, and a connector connecting the elongated member to an indicator, wherein the sensor determines the density of the blood clot and the indicator provides an indication of the density of the clot.

Claims

1. A method of preventing hemorrhaging of a vessel containing a blood clot in a patient by determining in a closed system a vitality of a portion of the vessel downstream of the blood clot to determine how to treat the blood clot by determining a pH level of blood downstream of the blood clot, the method comprising the steps of:

providing an elongated flexible member having a distal portion;

inserting the flexible member through vasculature of the patient and past the blood clot to a select position downstream of the blood clot in the vessel so the distal portion is positioned distal of the blood clot, the flexible member carrying a pH sensor;

after the pH sensor is in position distal of the blood clot, sensing the pH level of the blood downstream of the blood clot with the sensor positioned distal of the blood clot, the pH level of the blood downstream of the blood clot in the closed system indicative of the vitality of the vessel downstream of the blood clot; and

visually displaying to the user, via an indicating device in communication with the sensor, the pH level of the blood downstream of the blood clot prior to commencement of treatment of the blood clot to assess the vitality of the portion of the vessel downstream of the blood clot; and

subsequently determining to keep permanently in place the flood clot based on the pH level in the preceding displaying step falling outside a predetermined normal range to thereby prevent subsequent hemorrhaging of the vessel.

2. The method of claim 1, further comprising the step of determining a density of the blood clot to determine a clot treatment method.

3. The method of claim 1, wherein the step of determining the density of the blood clot utilizes a density sensor for transmitting ultrasonic waves.

4. The method of claim 3, wherein one of the density sensor and pH sensor is carried by a first elongated flexible member and the other sensor is carried by a second elongated flexible member coaxial with the first elongated member.

5. The method of claim 1, wherein the sensor remains distal of the blood clot during the entire sensing function.

6. The method of claim 1, wherein the step of keeping the blood clot occurs if the pH level falls below a predetermined range to indicate occurrence of acidosis compromising the vasculature.

7. The method of claim 1, wherein the predetermined normal range is a range of 7.35 to 7.45.

8. The method of claim 1, wherein the vitality of the vessel is assessed to treat cerebrovascular disease.

10. The method of claim 1, wherein the flexible elongated member and the pH sensor are inserted through a femoral approach.

11. The method of claim 1, wherein the flexible elongated member and the pH sensor are inserted through a brachial approach.

9. The method of clam 1, further comprising the step of taking a measurement of the blood pH upstream of the clot utilizing a second pH sensor carried by the flexible member and positioned proximal of the pH sensor positioned distal of the clot for comparative assessment.