System and catheter for image guidance and methods thereof

• US 9,554,774 B2
• Filed: 12/08/2009
• Issued: 01/31/2017
• Est. Priority Date: 12/08/2008
• Status: Active Grant

• Current Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Original Assignee: ACIST Medical Systems Incorporated (Bracco SPA)
• Inventors: Moore, Thomas C., Waters, Kendall R., Buech, Stephanie J., Zelenka, Robert
• Primary Examiner(s): Moher, Amanda Lauritzen
• Assistant Examiner(s): Mohammed, Shahdeep
• Application Number:
  US12/633,278
• Publication Number:
  US 20100152590A1
• Time in Patent Office: 2,611 Days
• Field of Search: 600/435
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/233 for the nose, i.e. nasoscopes , e.g. testing of patency of Eustachian tubes
• CPC Class Codes: A61B 1/2733 Oesophagoscopes
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/0883 for diagnosis of the heart
• 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 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61B 8/4466 involving deflection of the probe
• 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 8/5223 : for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: A61B 8/5253 : combining overlapping images, e.g. spatial compounding
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

A catheter-based imaging system includes a catheter having a telescoping proximal end, a distal end having a distal sheath and a distal lumen, a working lumen, and an ultrasonic imaging core. The ultrasonic imaging core is arranged for rotation and linear translation. The system further includes a patient interface module including a catheter interface, a rotational motion control system that imparts controlled rotation to the ultrasonic imaging core, a linear translation control system that imparts controlled linear translation to the ultrasonic imaging core, and an ultrasonic energy generator and receiver coupled to the ultrasonic imaging core. The system further includes an image generator coupled to the ultrasonic energy receiver that generates an image.

Claims

1. A catheter-based imaging system comprising:

a catheter having a telescoping proximal end, a distal end having a distal sheath and a distal lumen, a working lumen, and an ultrasonic imaging core, the ultrasonic imaging core being arranged for rotation and linear translation, the working lumen extending from the telescoping proximal end toward the distal end adjacent to the ultrasonic imaging core;

a patient interface module (PIM) including a linkage arm mount, a rotational motor, a gear and arm system comprising a first gear coupled to a linkage arm, and an ultrasonic energy generator and receiver coupled to the ultrasonic imaging core, the rotational motor being directly coupled to the first gear, and the linkage arm being directly coupled to the linkage arm mount, wherein the rotational motor imparts controlled rotation to the ultrasonic imaging core and the rotational motor is adapted to drive the gear and arm system to impart controlled, linear, and bidirectional translation to the ultrasonic imaging core, wherein the PIM includes a translation stage, the translation stage being rigidly fixed to both the first gear and the rotational motor, and the linkage arm being adapted to couple the first gear to the linkage arm mount, and wherein the rotational motor imparts controlled linear, and bidirectional translation by rotating the first gear such that the translation stage is linearly translated relative to the linkage arm mount via the linage arm; and

an imaging engine configured to electrically interface with the PIM, the imaging engine coupled to the ultrasonic energy receiver, the imaging engine adapted to generate an image.

2. The catheter-based imaging system of claim 1, wherein the catheter is adapted for intracardiac use.

3. The catheter-based imaging system of claim 1, wherein the catheter is adapted for transesophageal use.

4. The catheter-based imaging system of claim 1, further comprising a compliant balloon at the catheter distal end.

5. The catheter-based imaging system of claim 4, wherein the catheter comprises an inflation lumen in fluid communication with the balloon.

6. The catheter-based imaging system of claim 4, wherein the catheter comprises an inflation lumen and a deflation lumen in fluid communication with the balloon.

7. The catheter-based imaging system of claim 4, wherein the catheter distal end is in fluid communication with the balloon.

8. The catheter-based imaging system of claim 1, wherein the catheter is dimensioned for transnasal delivery.

9. The catheter-based imaging system of claim 1, wherein the ultrasonic imaging core comprises at least one transducer.

10. The catheter-based imaging system of claim 1, wherein the ultrasonic imaging core comprises at least one transducer array.

11. The catheter-based imaging system of claim 1, wherein the rotational motor comprises an ultrasonic piezoelectric motor.

12. The catheter-based imaging system of claim 1, wherein the PIM comprises a linear translation position sensor including a sensor array and a magnet disposed within the PIM, wherein linear translation of the ultrasonic imaging core causes a corresponding linear translation of the magnet relative to the sensor array, and wherein sensors of the sensor array are configured to sense the magnet and are aligned along a travel range of the magnet.

13. The catheter-based imaging system of claim 1, wherein the imaging engine is further adapted to identify susceptible substrates responsive to ultrasound tissue classifiers.

14. The catheter-based imaging system of claim 1, further comprising a temperature monitor that monitors luminal esophageal temperature responsive to ultrasound tissue classifiers.

15. The catheter-based imaging system of claim 9, wherein the imaging engine is further adapted to stitch scanned image sub-volumes into a large scanned image volume.

16. The catheter-based imaging system of claim 9, wherein the imaging engine is further adapted to be responsive to the ultrasonic imaging core to provide synthetic aperture imaging.

17. The catheter-based imaging system of claim 10, wherein the imaging engine is further adapted to be responsive to the at least one transducer array to provide synthetic aperture imaging.

18. The catheter-based imaging system of claim 9, wherein the imaging engine is further adapted to be responsive to the ultrasonic imaging core to provide synthetic aperture beam steering.

19. The catheter-based imaging system of claim 10, wherein the imaging engine is further adapted to be responsive to the at least one transducer array to provide synthetic aperture beam steering.

20. The catheter-based imaging system of claim 1, wherein the catheter distal end comprises a self-sealing septum, an atraumatic tip, and a septum puncture port.

21. The catheter-based imaging system of claim 1, wherein the catheter distal tip comprises a short monorail rapid exchange guidewire receiver.

22. The catheter-based imaging system of claim 1, wherein the catheter comprises an over-the-wire guidewire receiver.

23. The catheter-based imaging system of claim 1, wherein the catheter comprises a steerable section.

24. The catheter-based imaging system of claim 1, wherein the catheter comprises a second working lumen.

25. The catheter-based imaging system of claim 1, wherein the ultrasonic imaging core comprises a magnetic tracking sensor.

26. The catheter-based imaging system of claim 1, wherein the catheter distal sheath comprises a radio-opaque marker band.

27. A catheter-based imaging system, comprising:

a catheter having a telescoping proximal end, a distal end having a distal sheath and a distal lumen, a working lumen, and an ultrasonic imaging core, the ultrasonic imaging core being arranged for rotation and linear translation, the working lumen extending from the telescoping proximal end toward the distal end adjacent to the ultrasonic imaging core;

a patient interface module (PIM) including a linkage arm mount, a gear and arm system comprising a first gear coupled to a linkage arm, a rotational motor, a translation stage, and an ultrasonic energy generator and receiver coupled to the ultrasonic imaging core, linear rotational motor being directly coupled to the first gear, and the linkage arm being directly coupled to the linkage arm mount, wherein the rotational motor is adapted to impart controlled rotation to the ultrasonic imaging core and to drive the gear and arm system to impart controlled, linear, and bidirectional translation to the ultrasonic imaging core, and an ultrasonic energy generator and receiver coupled to the ultrasonic imaging core;

wherein the translation stage is rigidly fixed to the rotational motor, and wherein the rotational motor is configured to move along with and linearly translate the translation stage; and

an imaging engine configured to electrically interface with the PIM, the imaging engine coupled to the ultrasonic energy receiver, the imaging adapted to generate an image.