Ultrasonic vascular imaging system and method of blood vessel cannulation

• US 6,755,789 B2
• Filed: 02/05/2002
• Issued: 06/29/2004
• Est. Priority Date: 02/05/2002
• Status: Active Grant

• Current Assignee: Inceptio Medical Technologies, LLC
• Original Assignee: Inceptio Medical Technologies, LLC
• Inventors: Christensen, Douglas A., Ford, Cameron P., Stringer, Bradley J., Simmons, Gary A., Evensen, Robert W., Messerly, Shayne
• Primary Examiner(s): Imam, Ali M
• Application Number:
  US10/072,662
• Publication Number:
  US 20030149366A1
• Time in Patent Office: 875 Days
• Field of Search: 600/407, 600/437, 600/438, 600/440, 600/441, 600/442, 600/443, 600/447, 600/449-472, 128/916, 735/95--33, 367/7, 367/11, 367/130, 367/138
• US Class Current: 600/461
• CPC Class Codes: A61B 5/489 Blood vessels
• 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 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/13 Tomography A61B8/10, A61B8/12 take precedence; tomography for radiation diagnosis A61B6/02
• CPC Class Codes: A61B 8/145 characterised by scanning multiple planes
• CPC Class Codes: A61B 8/42 Details of probe positioning or probe attachment to the patient
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects

Abstract

An apparatus, method and system for cannulation of blood vessels. The apparatus comprises a sensor assembly including two linear transducer arrays oriented perpendicularly to each other to form a “T” shape to provide substantially simultaneous ultrasound images of at least one blood vessel in a portion of a patient'"'"'s body in two perpendicular planes. The apparatus may also include one or more Doppler transducer elements to transmit and receive one or more Doppler beams at an incident angle beneath one of the transducer arrays and in alignment therewith to determine blood flow direction and velocity within the at least one blood vessel. The sensor assembly may be disposed within an elongated, flexible, protective sheath and secured to a graphically marked cover to facilitate orientation of the sensor assembly on the patient and guidance of a needle towards a desired target vessel during the cannulation procedure. The cover may also include associated structure to cooperate with a reference location element to place, align and secure the sensor assembly to the patient'"'"'s skin at a desired location.

Claims

1. A system for use in cannulation of blood vessels in a body portion of a mammal, comprising:

a sensor assembly including two linear, mutually perpendicular ultrasonic transducers, each comprising at least one element and at least one ultrasonic Doppler transducer element, the sensor assembly being configured for placement on the body portion with transducer elements of the sensor assembly aimed thereat;

a beamformer operably coupled to the two linear, mutually perpendicular ultrasonic transducers and the at least one ultrasonic Doppler transducer element;

a dual B-mode digital scan converter operably coupled to the beamformer for converting signals therefrom to images respectively depicting a transverse sectional view of blood vessels in the body portion and a longitudinal sectional view of the blood vessels in the body portion;

Doppler signal processing hardware operably coupled to the at least one ultrasonic Doppler transducer element and configured to convert a Doppler signal received therefrom into a color image indicative of at least one direction of blood flow in at least one of the blood vessels of the body portion;

a host computer operably coupled to the Doppler signal processing hardware and the dual B-mode digital scan converter; and

a display device operably coupled to the host computer and configured to display the transverse sectional and longitudinal sectional views substantially simultaneously with the color image indicative of at least one direction of blood flow.

2. The system of claim 1, further comprising:

an elongated, flexible, protective sheath having an open end and a closed end and having the sensor assembly received therein and secured to a frame element adjacent a surface thereof proximate the closed end;

a cover located adjacent the frame element with the sensor assembly and a portion of the elongated, flexible, protective sheath disposed therebetween; and

a reference location element configured to be secured to skin of a patient and for cooperative placement of the cover thereover for movable affixation of the sensor assembly thereto.

3. The system of claim 1, wherein the at least one ultrasonic Doppler transducer element comprises two ultrasonic Doppler transducer elements configured from one of the linear, mutually perpendicular ultrasonic transducers.

4. The system of claim 1, further comprising a grid system employed with the sensor assembly and which grid system the display device is configured to display in association with a position of the sensor assembly to coordinate positioning of the sensor assembly on the body portion.

5. The system of claim 1, wherein the two, linear, mutually perpendicular ultrasonic transducers comprise:

a first linear, ultrasonic transducer array comprising a plurality of elements; and

a second linear, ultrasonic transducer array comprising a plurality of elements; and

wherein the sensor assembly further includes;

a housing carrying the first and second linear, ultrasonic transducer arrays and the at least one ultrasonic Doppler transducer element.

6. The system of claim 1, wherein the first and second linear, ultrasonic transducer arrays lie in mutually parallel planes and the elements of each of the first and second linear, ultrasonic transducer arrays are aimed substantially perpendicular to the planes.

7. The system of claim 1, wherein the first and second linear, ultrasonic transducer arrays are arranged to form a “

T”

shape with the first linear, ultrasonic transducer array defining a body of the “

T” and

the second linear, ultrasonic transducer array defining a head of the “

T.”

8. The system of claim 7, wherein the first linear, ultrasonic transducer array and the second linear, ultrasonic transducer array are each operably coupled to a multiconductor cable extending laterally from the housing at an angle to the body of the “

T.”

9. The system of claim 7, further comprising an elongated, protective, flexible sheath open at one end thereof and a frame element proximate a surface of the elongated, protective, flexible sheath at another, closed end thereof and engaged with the housing.

10. The system of claim 9, further comprising a cover engaged with the frame element and the housing with a portion of the elongated, protective, flexible sheath being interposed between the housing and the cover.

11. The system of claim 10, wherein the cover defines a needle guide at one end thereof proximate the head of the “

T.”

12. The system of claim 11, wherein the needle guide comprises a notch in the one end of the cover.

13. The system of claim 10, further comprising markings on an exterior surface of the cover indicative of two opposing directions of blood flow parallel to the body of the “

T.”

14. The system of claim 10, further comprising a set of longitudinal grid markings parallel to the body of the “

T” and

a set of transverse grid markings parallel to the head of the “

T”

on an exterior surface of the cover.

15. The system of claim 14, further comprising markings on the exterior surface of the cover indicative of two opposing directions of blood flow parallel to the body of the “

T.”

16. The system of claim 10, further including a ribbon bearing adhesive at two spaced locations on a surface thereof flanking an adhesive-devoid location thereof extending through at least one slot in a structure associated with the cover.

17. The system of claim 16, wherein the cover further includes selectively engageable gripping elements for gripping the ribbon.

18. The system of claim 10, wherein the cover comprises a pair of wings laterally extending from opposing sides thereof, each wing carrying a magnet.

19. The system of claim 18, further including a reference location element for securing to skin of a patient over a target blood vessel, the reference location element comprising a film carrying two elements of magnetic material, spaced about a same distance as a distance between the magnets and each of a greater lateral dimension than one of the magnets, the film including an adhesive thereon for affixation to the patient'"'"'s skin.

20. The system of claim 1, wherein the at least one ultrasonic Doppler transducer element is aligned with the first linear, ultrasonic transducer array, and carried by the housing.

21. The system of claim 20, wherein the at least one ultrasonic Doppler transducer element is adjacent an end of the first linear, ultrasonic transducer array.

22. The system of claim 21, wherein the at least one ultrasonic Doppler transducer element is aimed at an acute angle to a perpendicular to a plane of the first linear, ultrasonic transducer array.

23. The system of claim 22, wherein the acute angle is about 30°

and the at least one ultrasonic Doppler transducer element is further aimed toward the first linear, ultrasonic transducer array.

24. The system of claim 20, wherein the at least one ultrasonic Doppler transducer element comprises two ultrasonic Doppler transducer elements, each comprising a group of elements from the first linear, ultrasonic transducer array, each group of elements being separated from the other along a length of the first linear, ultrasonic transducer array.

25. The system of claim 24, wherein each of the two ultrasonic Doppler transducer elements is aimed at the same but opposing acute angles to a perpendicular to a plane of the first linear, ultrasonic transducer array.

26. The system of claim 25, wherein the opposing acute angles are each about 12.2°

.

27. The system of claim 26, wherein the elements of the first and second linear, ultrasonic transducer arrays each comprise a piezoelectric element.

28. The system of claim 20, wherein the elements of the first and second linear, ultrasonic transducer arrays and the at least one ultrasonic Doppler transducer element each comprise at least one piezoelectric element.

29. The system of claim 20, wherein the at least one ultrasonic Doppler transducer element is comprised of a piezoelectric transmitter and a piezoelectric receiver.

30. A method for the cannulation of a blood vessel, the method comprising:

obtaining and displaying a first ultrasound image of at least one blood vessel in a first imaging plane;

obtaining and displaying a second ultrasound image of the at least one blood vessel in a second imaging plane transverse to the first imaging plane;

obtaining Doppler information acquired at an angle incident to the second imaging plane and providing from the Doppler information a display of visually perceptible indicia indicative of blood flow direction in the at least one blood vessel;

viewing the displayed first and second ultrasound images of the at least one blood vessel and the display of visually perceptible indicia indicative of blood flow direction in the at least one blood vessel while guiding a needle having a catheter associated therewith to the at least one blood vessel; and

penetrating the at least one blood vessel with the needle.

31. The method of claim 30, further comprising displaying the first ultrasound image, the second ultrasound image and the display of visually perceptible indicia indicative of blood flow direction in the at least one blood vessel substantially simultaneously on a single display device.

32. The method of claim 30, wherein obtaining Doppler information acquired at an angle incident to the second imaging plane and providing from the Doppler information a display of visually perceptible indicia indicative of blood flow direction in the at least one blood vessel comprises obtaining a single scan line of Doppler information, color coding the single scan line to be indicative of blood flow direction, and displaying the single scan line overlaid on top of the second ultrasound image.

33. The method of claim 32 wherein color coding the single scan line to be indicative of blood flow direction comprises color coding blood flowing in one direction blue and color coding blood flowing in an opposing direction red.

34. The method of claim 30, further comprising obtaining the first ultrasound image, the second ultrasound image and the Doppler information using a single sensor assembly temporarily attached to a surface of a patient'"'"'s skin overlying the at least one blood vessel.

35. The method of claim 30, wherein obtaining the Doppler information comprises transmitting and receiving chirped ultrasound pulses to obtain Doppler information at discrete focal lengths.

36. The method of claim 30, wherein obtaining the Doppler information comprises transmitting and receiving ultrasound pulses to obtain Doppler information at discrete focal lengths.