1. Next Generation HD IVUS
Gary S. Mintz, MD
Cardiovascular Research Foundation
New York City, NY

2. Disclosure Statement of Financial Interest
Within the past 12 months, I have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
Grant/Research Support BostonScientific, Volcano
Consulting Fees/Honoraria BostonScientific, Volcano, LightLab
Major Stock Shareholder/Equity
Royalty Income
Ownership/Founder
Intellectual Property Rights
Other Financial Benefit

3. IVUS technology has been clinically available for over 20 years. Yet. . .
Image quality has not improved in the last 10 years.
Poor spatial resolution and catheter-to-catheter imaging inconsistency are problematic.
Current IVUS systems are not capable of resolving structures <100 μm (and maybe <150μm ) in size.
Poor image quality often requires expert interpretation, inhibits confidence in new users, and is a primary obstacle to maximizing growth and adoption of IVUS technology.

4. But what if
What if we could start from scratch to design an IVUS system – transducer, catheter, catheter interface, console, etc – using 2011 technology as well as 15 years of knowledge What would this system look like?
However, building a high-definition image requires optimizing the entire system. Improvements to any one system component (e.g., transducer) may enhance performance, but not optimizing each component of the imaging chain will not yield the targeted improvements.
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5. What determines image quality?
Pulse Duration
Frequency
Transducer
Bandwidth
Image Quality
Image quality is made up of many different factors. Much more than just frequency.
Transducer shape
Signal/Noise Ratio
Pulse Length

6. But, how is image quality defined?
Contrast Resolution
Penetration
Axial
Resolution
Lateral
Resolution
Resolution defines image quality – just like in TVs
When you buy an HDTV you don’t care about the technical details of an LCD or a picture tube, you care about the resolution of the set!

7. Transducer
The ultrasonic transducer is the heart of the system. No amount of signal processing can overcome poor signal fidelity from the transducer.
Axial resolution is improved by increasing the frequency domain (fractional bandwidth) of the transducer and by shortening the time domain (impulse) response
Lateral resolution is improved by increasing the effective aperture (surface area) and focusing the transducer (concave surfaces).
Sensitivity is the efficiency of the conversion from an electrical impulse to an acoustic wave (transmit) and vice versa (receive). Improved sensitivity results in better signal to noise ratio and increases penetration.
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8. Effective Axial Resolution [microns]
Transducer A B C D
-20db pulse width [nsec]
Effective Axial Resolution [microns]
Commercial Transducer #1 (A)
145
135
Commercial Transducer #2 (B)
175
165
HD 40MHz transducer (C) 85 80
HD 60MHz transducer (D) 55 50

9. Spherically-focused Polymer Film Transducer
Commercial Transducer #2 (B)
Next generation transducers will incorporate new materials and geometries. Several candidate materials that are currently under investigation include thin and thick film piezoelectric materials and composite materials.
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Chandrana et al., IEEE Ultrasonics Symposium, 2007 8

10. Transducer
Single Flat Transducer
Dual Transducer
Next generation HD-IVUS transducers may also include dual transducer configurations that will be optimized for very broadband imaging applications, including harmonic imaging, and multiband fusion imaging.
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11. Multifrequency Imaging
60MHz
20MHz
Cross-
Correlation
of the two
Frequencies
Multifrequency Imaging

12. Harmonic imaging to detect vasovasorum by contrast bubble targeting
during injection
One hypothesis is that Vasa Vasorum density correlates with the amount of inflammation and hence vulnerability of the lesion.
Before Injection
After Injection
Transmit
Receive
Harmonic imaging to detect vasovasorum by contrast bubble targeting
Here you see that clinical applications that we believe this technology can be useful for: vasa vasorum detection and targeting the bubbles with surface ligand for particular tissue type or disease state. Some may also suggest that the bubbles themselves can also carry some therapeutic drug.
You can see the two blue images here – the one on the left is before bubble injection and the one on the right is after bubble injection – you can see the increased in brightness in some region – we believe this qualitatively measures the density of vasa vasorum. The panel below these two blue images shows a more quantitative way to estimate the amount of enhancement at a particular region of interest.
On the right, the histology indicates the presence of vasa vasorum and the hypothesis that this application is interesting because it might be a proxy for inflammation which might indicate the vulnerability of a lesion.
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13. Catheter and System Interface
Necessary catheter improvements
Improved handling performance
Elimination of imaging core wind up
Resolved flushing issues
Improved transducer connections
Decreased resistance
Improved reliability
Improved catheter/system interface
High definition resolution
Reduced image acquisition time
Support for higher frequency devices
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14. Instrument and Data Stream
Square wave pulse width tuning
Frequency-modulated pulse (Chirp)
A major part of instrument technology involves the transducer pulsing techniques. Pulse shaping technologies include square wave tuning and chirping (with pulse compression) that can optimize the transmitted ultrasonic energy and increase the depth of penetration.
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15. Instrument and Data Stream
In the back end of the system, high performance digital signal processing enables the generation of vivid, clean images.
HD-IVUS image data should increase the densities of the number of vectors/frame and image samples/vector.
Increased frame rates should provide sharp, quick longitudinal views.
Instrument technology improvements include using dual transmit/receive channels with mechanical IVUS. The use of dual channels enables advanced imaging techniques such as multiband image fusion and harmonic imaging.
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16. High Definition IVUS Feature SVMI HD-IVUS BSC iLab / Atlantis Volcano
s5/Revolution
LLI/SJM
C7-XR/C7-Dragonfly
Frequency/wavelength
40 & 60MHz
40MHz
45MHz
1300nm
Energy
Ultrasound
NIR Light
Axial Resolution
<50 μm
~150 μm
~200 μm
~15 μm
Max. Frame Rate
100 fps
30 fps
Max. Pullback Speed
20 mm/sec
1.0 mm/sec
Frame Spacing
200 μm
33 μm
Elevational Resolution
~400 μm
~600 μm
~40 μm
Tissue Penetration
>4 mm
>5 mm mm
Imaging in Blood
Yes No

17. 50 μm
25 μm

18. In-Vitro human cadaver image sequence
Distal
Frame Spacing: 160 μm
Proximal

19. Image Features (in blood)
Fibrous Cap (>100 um) Overlying an Acellular Region
(based on histology slide)
Image Features
Guide Wire
(unobtrusive shadowing)
Media
(echolucent band)
Catheter Mask
Plaque Lumen Border
Plaque Media-Adventitia Border
Echoes due to Sheath
(in blood)
Side Branch
(based on histology slides)
Confidential
9/11/2018