US2021127986A1PendingUtilityA1

Systems and methods for assessing vasculature health and blood clots

Assignee: MAKAHA MEDICAL LLCPriority: Oct 24, 2012Filed: Jan 8, 2021Published: May 6, 2021
Est. expiryOct 24, 2032(~6.3 yrs left)· nominal 20-yr term from priority
A61B 8/5223A61B 8/0833A61B 8/461A61B 8/4494A61B 8/467A61B 5/14539A61B 5/14542A61B 8/485A61B 8/12A61B 5/14503G16H 50/30A61B 8/085A61B 5/6852A61B 8/445A61B 5/02007A61B 8/0891A61B 5/14551A61B 5/6851
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Claims

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

exact text as granted — not AI-modified
1 - 20 . (canceled) 
     
     
         21 . A system for determining a density of a blood clot in a vessel of a patient during a surgical procedure for subsequent selection of a blood clot treatment method during the surgical procedure, the system comprising:
 a flexible elongated member configured and dimensioned for insertion in the vessel to navigate the small vessels of the patient and dimensioned and configured to receive a catheter thereover once positioned adjacent the blood clot, the elongated member having a proximal portion and a distal portion, and the elongated member distal portion configured for insertion adjacent the blood clot,   a sensor positioned at the distal portion of the elongated member, and   a connector coupled to the elongated member connecting the elongated member to a density reader providing an indicator and including a logic circuit configured to determine values, the sensor determining the density of the blood clot via a change in time between a sent and received signal and the indicator providing an indication of the determined density determined by the change in time, the indicator providing a numeric value display representative of a value within a range of predetermined densities to provide a comparative density value with the range of predetermined densities determined prior to treatment and prior to insertion of the elongated member, the range of predetermined densities identifying soft and hard clot to provide a baseline in vivo during the surgical procedure to thereby provide a guide for selection of subsequent blood clot treatment during the surgical procedure, wherein the predetermined range of values has a first series of values assigned to soft clot and a different series of values assigned to hard clot, the predetermined values determined by measured average densities of soft clot and hard clot, the predetermined values guiding blood clot treatment selection.   
     
     
         22 . The system of  claim 21 , wherein the flexible elongated member comprises a solid guidewire and a polymer jacket contains wires on an outer surface of the guidewire, the wires extending to connect the sensor to the connector. 
     
     
         23 . The system of  claim 21 , wherein the flexible elongated member comprises a guidewire having a lumen through which wires extend to connect the sensor to the connector. 
     
     
         24 . The system of  claim 21 , wherein the sensor includes a transmitter at the distal portion of the elongated member for transmitting ultrasonic waves toward the blood clot, and the density of the blood clot is determined by ultrasonic wave feedback. 
     
     
         25 . The system of  claim 21 , further comprising a pH sensor for measuring pH of blood downstream of the clot and an indicator for indicating measured pH. 
     
     
         26 . The system of  claim 21 , further comprising an oxygen sensor for measuring oxygen level of blood downstream of the clot and an indicator for indicating measured oxygen. 
     
     
         27 . The system of  claim 26 , wherein the density sensor is positioned proximal of the distal tip of the elongated member. 
     
     
         28 . The system of  claim 21 , wherein the connector is frictionally clamped onto a wall of the elongated member. 
     
     
         29 . The system of  claim 21 , wherein the sensor includes a piezoelectric signal transducer to generate an ultrasonic signal and receive a reflected signal. 
     
     
         30 . The system of  claim 28 , wherein the connector includes a flexible clip clampable onto an outer wall of the elongated member. 
     
     
         31 . The system of  claim 30 , wherein the clip is clamped proximal of a hub of the catheter through which the elongated member extends. 
     
     
         32 . The system of  claim 21 , wherein the sensor extends circumferentially around the flexible elongated member. 
     
     
         33 . The system of  claim 21 , wherein wires of the sensor are embedded in a wall of the flexible elongated member. 
     
     
         34 . The system of  claim 23 , wherein the wires are insulated within the lumen. 
     
     
         35 . The system of  claim 21 , wherein the flexible elongated member has a marker band at a distal end and the sensor is incorporated into the marker band. 
     
     
         36 . The system of  claim 21 , wherein the sensor is exposed to measure density by proximal movement of the catheter over the flexible elongated member. 
     
     
         37 . The system of  claim 21 , wherein a lower numeric value is assigned to soft clot and a higher numeric value is assigned to hard clot. 
     
     
         38 . A method for determining a density of a blood clot in a vessel of a patient during a surgical procedure for subsequent selection of a blood clot treatment method during the surgical procedure, the method comprising:
 inserting into the vessel and adjacent a blood clot a flexible elongated member having a sensor and configured and dimensioned to navigate small vessels of the patient and configured and dimensioned to receive a catheter thereover once positioned adjacent the blood clot;   sensing the density of the blood clot via a change in time between a sent and received signal and providing via an indicator an indication of the determined density determined by the change in time, the indicator providing a numeric value display representative of a value within a range of predetermined densities to provide a comparative density value with the range of predetermined densities determined prior to treatment and prior to insertion of the elongated member, the indicator part of a density reader including a logic circuit configured to determine density values, and   identifying soft and hard clot based on the range of densities which provide a baseline in vivo during the surgical procedure to thereby provide a guide for selection of subsequent blood clot treatment during the surgical procedure, wherein the predetermined range of values has a first series of values assigned to soft clot and a different series of values assigned to hard has a first series of values assigned to soft clot and a different series of values assigned to hard clot, the predetermined values determined by measured average densities of soft clot and hard clot.   
     
     
         39 . The method of  claim 38 , further comprising the step of measuring pH of blood downstream of the clot via a pH sensor at the distal portion of the elongated member. 
     
     
         40 . The method of  claim 38 , further comprising the step of measuring oxygen level of blood downstream of the clot.

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