System and method for measuring fluidics in arteries

• US 9,795,359 B2
• Filed: 11/18/2016
• Issued: 10/24/2017
• Est. Priority Date: 07/08/2014
• Status: Active Grant

• Current Assignee: Nadarasa Visveshwara
• Original Assignee: Nadarasa Visveshwara
• Inventors: Visveshwara, Nadarasa
• Primary Examiner(s): Peng, Bo J
• Application Number:
  US15/356,280
• Publication Number:
  US 20170065251A1
• Time in Patent Office: 340 Days
• CPC Class Codes: A61B 2503/045 Newborns, e.g. premature baby monitoring
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/150038 for blood from umbilical cord
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/065 to determine blood output from the heart in general A61B5/029
• CPC Class Codes: A61B 8/0866 involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
• 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 8/4416 related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4477 using several separate ultrasound transducers or probes
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/488 involving Doppler signals
• 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

Abstract

An apparatus for performing measurements in an artery includes a Doppler catheter, comprising a Doppler transducer and a wire connected to the Doppler transducer; and an elongated catheter body having a conduit therein for housing the wire of the Doppler catheter. The body has a proximal end and a distal end; wherein the wire is movable in the conduit relative to the catheter body so that the Doppler transducer and the wire are capable of being threaded into said conduit at the proximal end after the distal end of the catheter has been inserted into the artery, until the Doppler transducer emerges outside the conduit at the distal end of said body for performing ultrasound measurements in the artery. Another embodiment employs at least an additional side transducer for measuring the cross-sectional dimension of the artery useful for computing blood flow.

Claims

1. An apparatus for performing measurements in an artery, comprising:

a Doppler transducer;

a wire, capable of carrying an electrical signal along a length of the wire, the wire having a distal end connected to the Doppler transducer at a distal portion of the wire, and the wire having a proximal end;

a first connector having an opening through which the wire would pass during operation of the apparatus;

a second connector at the proximal end of the wire, suitable for electrical connections to the wire;

a catheter body having a proximal end and a distal end and having a conduit therein for containing portions of the wire;

an enclosing sleeve having a first position and a second position wherein, when in the first position, the enclosing sleeve encloses substantially all of the wire save for the distal portion of the wire connected to the Doppler transducer, and wherein, when in the second position, the enclosing sleeve does not enclose a majority of the wire and unenclosed portions of the wire would pass into the conduit of the catheter body;

a third connector attached to the catheter body at the proximal end of the catheter body, shaped to mate with the first connector to form a stable connection between the catheter body and the enclosing sleeve;

wherein, after the stable connection has been formed, the wire and Doppler transducer are movable in the conduit through the stable connection with movement of the Doppler transducer being from around the proximal end of the catheter body to beyond the distal end of the catheter body, whereby the Doppler transducer can emerge outside the conduit at the distal end of the catheter body for performing ultrasound measurements in the artery; and

wherein the enclosing sleeve provides a barrier between the wire and an environment when the wire is withdrawn from the catheter body.

2. The apparatus of claim 1, wherein the enclosing sleeve is shorter than the wire such that when the wire is withdrawn from the conduit, the length of the enclosing sleeve limits an extent by which the wire can be withdrawn from the conduit.

3. The apparatus of claim 1, further comprising a cap for connection to the first connector when the Doppler transducer and wire are not connected to the catheter body, to enclose and protect the Doppler transducer.

4. The apparatus of claim 1, wherein the first connector provides centering for the Doppler transducer for when the Doppler transducer is inserted into the conduit of the catheter body.

5. The apparatus of claim 1, wherein the third connector comprises:

a first port that permits the Doppler transducer and the wire to pass there through and be inserted into the conduit;

a second port coupled to the proximal end of the catheter body; and

a third port providing a clear path enabling blood pressure in the artery near the distal end of the catheter body to be monitored through the second port whether or not the Doppler transducer and the wire are in the conduit.

6. The apparatus of claim 1, wherein the third connector comprises:

a first port that permits the Doppler transducer and the wire to pass there through and be inserted into the conduit;

a second port coupled to the proximal end of the catheter body; and

a third port providing a clear path enabling infusion of a substance to the artery, retrieval of blood samples, or monitoring blood pressure in the artery near the distal end of the catheter body.

7. The apparatus of claim 6, wherein the third port provides the clear path whether or not the Doppler transducer and the wire are in the conduit.

8. The apparatus of claim 6, wherein the third connector is Y-shaped.

9. The apparatus of claim 8, wherein the third port is located on the third connector between the first port and the second port.

10. The apparatus of claim 1, wherein the catheter body comprises a material firm enough to enable the catheter body to be inserted into arteries but flexible enough to bend along turns in the arteries as in an umbilical artery in newborns.

11. The apparatus of claim 1, wherein the catheter body comprises a material rigid enough to be placed in tandem with a cardiac assist device or within the cardiac assist device.

12. The apparatus of claim 1, wherein the catheter body comprises polyurethane or metal.

13. The apparatus of claim 1, further comprising at least one second transducer for measuring at least one cross-sectional dimension of the artery, and at least one second wire connected to the at least one second transducer.

14. The apparatus of claim 13, further comprising:

ground wires for the Doppler transducer and the second transducer; and

a housing containing the wire, the at least one second wire and the ground wires with the ground wires connected to the housing.

15. The apparatus of claim 13, wherein the Doppler transducer or the second transducer are used for measuring blood mean velocity in the artery.

16. The apparatus of claim 1, wherein the Doppler transducer is configured to be positioned to send ultrasound waves in a direction substantially parallel to blood flow for ultrasound measurement of blood mean velocity in the artery.

17. The apparatus of claim 1, wherein the Doppler transducer is configured to provide continuous measurement of cardiac output.

18. An apparatus for performing measurements in an artery, comprising:

a Doppler transducer;

a second transducer;

a wire set comprising a plurality of wires, capable of carrying an electrical signal along a length of the wire set, the wire set having a proximal end and having a distal end with at least one wire of the wire set connected to the Doppler transducer at a distal portion of the wire set and at least one other wire of the wire set connected to the second transducer at the distal portion of the wire set;

a first connector having an opening through which the wire set would pass during operation of the apparatus;

a second connector at the proximal end of the wire set, suitable for electrical connections to connected wires of the plurality of wires;

a catheter body having a proximal end and a distal end and having a conduit therein for containing portions of the wire set;

an enclosing sleeve having a first position and a second position wherein, when in the first position, the enclosing sleeve encloses substantially all of the wire set save for the distal portion of the wire set connected to the Doppler transducer and the second transducer, and wherein, when in the second position, the enclosing sleeve does not enclose a majority of the wire set and unenclosed portions of the wire set would pass into the conduit of the catheter body;

a third connector attached to the catheter body at the proximal end of the catheter body, shaped to mate with the first connector to form a stable connection between the catheter body and the enclosing sleeve;

wherein, after the stable connection has been formed, the wire set, the Doppler transducer and the second transducer are movable in the conduit through the stable connection with movement of the Doppler transducer and the second transducer being from around the proximal end of the catheter body to beyond the distal end of the catheter body, whereby the Doppler transducer and the second transducer can emerge outside the conduit at the distal end of the catheter body for performing ultrasound measurements in the artery after the distal end of the catheter body has been inserted into the artery for performing ultrasound measurement in the artery and measurement of a cross-sectional dimension of the artery; and

wherein the enclosing sleeve provides a barrier between the wire set and an environment when the wire set is withdrawn from the catheter body.

19. A method for performing measurements in an artery, comprising:

providing a Doppler transducer and a wire capable of carrying an electrical signal along a length of the wire, the wire having a distal end connected to the Doppler transducer at a distal portion of the wire, and the wire having a proximal end;

inserting, into a patient, a catheter body having a proximal end and a distal end and having a conduit therein for containing portions of the wire;

moving an enclosing sleeve from a first position to a second position, the first position being wherein the enclosing sleeve encloses substantially all of the wire save for the distal portion of the wire connected to the Doppler transducer, and the second position being wherein the enclosing sleeve does not enclose a majority of the wire and unenclosed portions of the wire would pass into the conduit of the catheter body, while the wire is sterile and the enclosing sleeve provides a barrier between the wire and an environment at least in the first position;

wherein moving the enclosing sleeve from the first position to the second position moves the wire and Doppler transducer in the conduit;

positioning the wire such that the Doppler transducer emerges outside the conduit at the distal end of the catheter body for performing ultrasound measurements in the artery; and

making an ultrasound measurement.

20. The method of claim 19, wherein the ultrasound measurement comprises measuring retrograde flow and antegrade flow.

21. The method of claim 19, further comprising:

measuring antegrade blood flow through an aorta of the patient to a body of the patient;

measuring retrograde blood flow through a ductus arteriosus of the patient; and

determining, in real time, a shunt fraction through the ductus arteriosus.

22. The method of claim 19, further comprising:

providing a second transducer; and

measuring a time of travel of sound waves and their reflection between the second transducer and an adjacent wall of the artery for use in determining a distance between the second transducer and the adjacent wall of the artery.

23. The method of claim 22, further comprising:

providing additional transducers; and

making additional time of travel measurements in a plurality of directions to determine a plurality of distances between the additional transducers and the adjacent wall of the artery for noncircular cross-section arteries.

24. The method of claim 22, further comprising:

rotating the second transducer to obtain additional time of travel measurements in a plurality of directions to determine a plurality of distances between the second transducer and the adjacent wall of the artery for noncircular cross-section arteries.

25. The method of claim 19, further comprising positioning the Doppler transducer to be proximate to a patent ductus arteriosus of a neonatal patient before making the ultrasound measurement.