Electrophysiology mapping and visualization system

• US 8,934,962 B2
• Filed: 08/31/2007
• Issued: 01/13/2015
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Original Assignee: Intuitive Surgical Operations, Inc. (Intuitive Surgical Holdings, LLC)
• Inventors: Saadat, Vahid, Peh, Ruey-Feng, Tam, Edmund A.
• Primary Examiner(s): Luong, Peter
• Application Number:
  US11/848,532
• Publication Number:
  US 20090054803A1
• Time in Patent Office: 2,692 Days
• Field of Search: 600372-374, 600/407, 600/466, 600/476, 600/478
• US Class Current: 600/476
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00085 Baskets
• CPC Class Codes: A61B 1/00089 Hoods
• CPC Class Codes: A61B 1/00097 Sensors
• CPC Class Codes: A61B 1/005 Flexible endoscopes
• CPC Class Codes: A61B 1/015 Control of fluid supply or evacuation
• CPC Class Codes: A61B 1/018 for receiving instruments
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0477 : with pre-tied sutures
• CPC Class Codes: A61B 2017/12127 : Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22038 : with a guide wire
• CPC Class Codes: A61B 2017/22054 : with two balloons
• CPC Class Codes: A61B 2017/22067 : Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22069 : Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22082 : after introduction of a substance
• CPC Class Codes: A61B 2017/3445 : used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3484 : Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• 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 2034/107 : Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 : Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/301 : for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/306 : using optical fibres
• CPC Class Codes: A61B 2090/309 : using white LEDs
• CPC Class Codes: A61B 2090/3614 : using optical fibre
• CPC Class Codes: A61B 2090/373 : using light, e.g. by using optical scanners
• CPC Class Codes: A61B 2090/3958 : emitting a signal
• CPC Class Codes: A61B 34/20 : Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/30 : Surgical robots
• CPC Class Codes: A61B 5/0031 : Implanted circuitry
• CPC Class Codes: A61B 5/0084 : for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/02007 : Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6882 : Anchoring means
• 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 8/4472 : Wireless probes
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61M 5/007 : for contrast media

Abstract

Electrophysiology mapping and visualization systems are described herein where such devices may be used to visualize tissue regions as well as map the electrophysiological activity of the tissue. Such a system may include a deployment catheter and an attached hood deployable into an expanded configuration. In use, the imaging hood is placed against or adjacent to a region of tissue to be imaged in a body lumen that is normally filled with an opaque bodily fluid such as blood. A translucent or transparent fluid, such as saline, can be pumped into the imaging hood until the fluid displaces any blood, thereby leaving a clear region of tissue to be imaged via an imaging element in the deployment catheter. A position of the catheter and/or hood may be tracked and the hood may also be used to detect the electrophysiological activity of the visualized tissue for mapping.

Claims

1. A system for use in a body lumen, the body lumen containing blood, the system comprising:

a catheter having a fluid lumen defined therethrough;

an imaging assembly having a barrier supported by the catheter, the barrier being reconfigurable from a low-profile shape to an expanded deployment shape projecting distally from a distal end of the catheter and defining an open area which is in fluid communication with the fluid lumen and with an environment external to the barrier through an opening defined by the barrier;

an imaging element positioned within or along the barrier such that a tissue surface region adjacent to the open area is able to be visualized through the open area via the imaging element, where the imaging assembly is configured to acquire a tissue surface image of the tissue surface region while at least a portion of the blood is disposed in the body lumen and while the open area remains in fluid communication through the opening with the environment;

at least one sensor positioned along a distal portion of the barrier and configured to detect an electrical activity of the tissue surface when the barrier is in the expanded deployment shape; and

a processor in electrical communication with the imaging assembly and the at least one sensor so as to receive the detected electrical activity and tissue surface image, the processor configured to map the detected electrical activity and tissue surface image together.

2. The system of claim 1 wherein the imaging assembly comprises a fluid path for locally displacing blood from an area of the body lumen bordering the tissue surface region.

3. The system of claim 2 wherein the processor is configured to generate a map of the electrical activity of the tissue region detected via the sensor.

4. The system of claim 3 wherein the processor is further configured to correlate the map of the electrical activity with a visual image of the tissue region against or adjacent to the open area.

5. The system of claim 1 wherein at least one additional sensor is mounted on the catheter.

6. The system of claim 1 wherein the catheter is in electrical communication with a tracking system for generating location signals associated with the tissue surface image, and wherein the processor registers the detected electrical activity and tissue surface image using the location signals from the tracking system.

7. The system of claim 6 wherein the processor is configured to receive a plurality of tissue surface images and a plurality of electrical activity signals from a plurality of electrical activity sensing locations, and wherein the processor transmits an output signal with at least some of the electrical activity signals superimposed with at least some of the tissue surface images.

8. The system of claim 6 wherein the catheter comprises an electrophysiology catheter having a tracking system for generating electrophysiology tracking signals, and wherein the electrophysiology catheter is coupleable to the processor, the processor registering the detected electrical activity to the tissue surface image in response to the location signals and the electrophysiology tracking signals.

9. The system of claim 1 wherein the imaging element comprises a CMOS, CCD, or optical fiber imager.

10. The system of claim 1 wherein the imaging element is disposed within a distal end of the catheter.

11. The system of claim 1 wherein the imaging element is articulatable off-axis relative to a longitudinal axis of the catheter.

12. The system of claim 1 further comprising a fluid reservoir fluidly coupled to the barrier via the fluid lumen.

13. The system of claim 12 wherein the fluid reservoir comprises saline, plasma, water, or perfluorinated liquid.

14. The system of claim 1 wherein the at least one sensor is further configured to detect an orientation or location of the barrier relative to the tissue region.

15. The system of claim 1 wherein the at least one sensor comprises a metallic strut spirally disposed along the barrier.

16. The system of claim 1 wherein the at least one sensor comprises at least one coil sensor positioned along or upon the barrier along a first axis relative to the barrier.

17. The system of claim 16 further comprising a second coil sensor positioned along or upon the barrier along a second axis relative to the barrier, wherein the second axis is transverse to the first axis.

18. The system of claim 17 further comprising a third coil sensor positioned along or upon the barrier along a third axis relative to the barrier, wherein the third axis is transverse to the first and second axes.

19. The system of claim 1 wherein the at least one sensor comprises a triple coil sensor positioned along or upon the barrier.

20. The system of claim 1 further comprising at least one reference sensor positioned along the catheter proximal to the barrier such that the reference sensor is coincident with an anatomical landmark when the catheter is introduced within a patient body.

21. The system of claim 1 wherein the at least one sensor comprises an electrode positioned along the barrier.

22. The system of claim 21 further comprising a plurality of electrodes positioned about a circumference of the barrier.

23. The system of claim 22 further comprising a plurality of additional electrodes positioned along at least one support strut disposed along the barrier.

24. A method for use in a body lumen, the system comprising:

positioning a barrier projecting distally from a catheter within the body lumen, the barrier having a low-profile delivery configuration and an expanded deployment configuration where the barrier defines an open area;

introducing a transparent fluid into the open area via a fluid lumen defined through the catheter until blood is displaced from the open area and flows into an environment external to the barrier;

acquiring a tissue surface image of a tissue surface region of the body lumen through the transparent fluid within the open area by viewing the tissue surface region through the open area via an imaging element positioned within or adjacent to the barrier while blood is disposed in the body lumen external to the barrier and while the open area remains in fluid communication with the environment;

detecting an electrical activity of the tissue surface region via at least one sensor positioned along a distal portion of the barrier;

mapping the detected electrical activity and tissue surface image; and

providing a diagnosis or treatment in response to the mapped detected electrical activity and tissue surface image.

25. A method of sensing a tissue region within a body lumen, comprising:

positioning an open area of a barrier projecting distally from a catheter against or adjacent to the tissue region to be sensed, the barrier having a low-profile delivery configuration and an expanded deployment configuration where the barrier defines an open area;

displacing an opaque fluid from the open area and into an environment external to the open area through an opening defined by the barrier, where the opaque fluid is displaced with a transparent fluid introduced via a fluid lumen defined through the catheter;

visualizing the tissue region adjacent to the open area through the transparent fluid by viewing the tissue region through the open area via an imaging element positioned within or adjacent to the barrier while the open area remains in fluid communication through the opening with the environment; and

detecting an electrical activity of the tissue region against or adjacent to the open area via at least one sensor positioned along a distal portion of the barrier.

26. The method of claim 25 wherein positioning comprises advancing the barrier into a left atrial chamber of a heart.

27. The method of claim 25 wherein the barrier projects distally from the catheter.

28. The method of claim 25 wherein positioning comprises stabilizing a position of the barrier relative to the tissue region.

29. The method of claim 25 wherein infusing the transparent fluid comprises pumping saline, plasma, water, or perfluorinated liquid into the open area such that blood is displaced from therefrom.

30. The method of claim 25 wherein the imaging element is positioned within the catheter.

31. The method of claim 25 wherein the imaging element comprises a CMOS imager, CCD imager, or optical fiber.

32. The method of claim 25 wherein detecting comprises sensing the electrical activity via at least one sensor.

33. The method of claim 25 wherein detecting comprises sensing the electrical activity via a plurality of sensors positioned upon or along a circumference of the barrier.

34. The method of claim 25 further comprising determining an orientation or location of the barrier relative to the tissue region.

35. The method of claim 25 further comprising mapping the detected electrical activity of the tissue region.

36. The method of claim 35 further comprising overlaying a map of the detected electrical activity with visual images of the tissue region.