Guided cardiac ablation catheters

• US 8,540,704 B2
• Filed: 06/10/2004
• Issued: 09/24/2013
• Est. Priority Date: 07/14/1999
• Status: Expired due to Term

• Current Assignee: Cardiofocus Incorporated
• Original Assignee: Cardiofocus Incorporated
• Inventors: Melsky, Gerald, Arnold, Jeffrey M., Sinofsky, Edward L., Farr, Norman E.
• Primary Examiner(s): ROANE, AARON F
• Application Number:
  US10/865,558
• Publication Number:
  US 20050065504A1
• Time in Patent Office: 3,393 Days
• Field of Search: 606/2, 606 14- 16, 606/32, 606/41
• US Class Current: 606/15
• CPC Class Codes: A61B 1/00045 Display arrangement
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00165 with light-conductive means, e.g. fibre optics A61B1/07 takes precedence
• CPC Class Codes: A61B 1/00195 with eyepieces
• CPC Class Codes: A61B 1/05 characterised by the image sensor, e.g. camera, being in the distal end portion
• CPC Class Codes: A61B 1/3137 for examination of the interior of blood vessels
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 18/22 the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• 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 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/2261 with scattering, diffusion or dispersion of light
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61N 2005/1003 : having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

Guided ablation instruments are disclosed for creating lesions in tissue, especially cardiac tissue for treatment of arrhythmias, including atrial fibrillation. In one aspect of the invention, a percutaneous catheter is disclosed with an endoscope positionable in the instrument'"'"'s distal end region to obtain an image. The image allows the clinician to determine whether contact has been achieved (or blood has been cleared from an ablative energy transmission path) before ablation begins or while ablation is occurring. In one embodiment, percutaneous ablation catheters are disclosed having at least one central lumen and one or more balloon structures at the distal end region of the instrument. Also disposed in the distal end region are an illuminating light source and an endoscope capable of collecting sufficient light to relay an image to the user. The instruments can further include an ablation element. The ablation element can be a contact ablation element, or a radiant energy emitter, which is preferably independently positionable within the lumen of the instrument and adapted to project ablative energy through a transmissive region of the instrument body (and/or balloon) to a target tissue site proximate to the pulmonary veins. The energy can delivered without the need for contact between the energy emitter and the target tissue so long as a clear transmission pathway is established. The endoscope element of the instrument allows the clinician to determine the position of the instrument and, if radiant energy is to be employed, see if such a pathway is clear. Moreover, because the position of the radiant energy emitter can be varied, endoscopic guidance permits the clinician to select a desired location and dose for the lesion.

Claims

1. A cardiac ablation instrument for treatment of atrial fibrillation comprising:

a catheter adapted for disposition within a heart;

an expandable balloon member coupled to the catheter and adapted for positioning proximate to a pulmonary vein;

an ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein; and

a reflectance sensor for positioning the ablation element relative to the pulmonary vein,

wherein the instrument further comprises at least one orientation marker detectable by the reflectance sensor, the orientation marker being configured to determine the angular position of the instrument relative to the pulmonary vein.

2. The instrument of claim 1, wherein the marker is located on the ablation element.

3. The instrument of claim 1, wherein the marker is on the expandable balloon of the instrument.

4. The instrument of claim 1, wherein the marker is detectable fluoroscopically.

5. The instrument of claim 1, wherein the orientation marker is adapted to be visualized together with an aiming beam.

6. The instrument of claim 1, wherein the orientation marker comprises a ring formed on the balloon, the ring adapted to facilitate dose selection.

7. The instrument of claim 1, wherein the orientation markers comprises multiple rings formed on the balloon, the rings adapted to facilitate dose selection.

10. The instrument of claim 1, wherein the ablation element is capable of axial movement such that it can be deployed at various positions to deliver ablative energy to a target tissue site.

11. The instrument of claim 1, wherein the ablation element is a radiant energy ablation element.

12. The instrument of claim 11, wherein the radiant energy ablation element is selected from the group consisting of microwave, x-ray, beta radiation, ionizing radiation, ultrasound, and light ablation elements.

13. The instrument of claim 12, wherein the radiant energy ablation element further comprises a light transmitting optical fiber adapted to receive radiant energy from a light source and a light emitting tip at a distal end of the fiber for emitting light.

14. The instrument of claim 12, wherein the ablation element comprises an ultrasound transducer.

15. The instrument of claim 12, wherein the ablation element comprises a microwave generator.

16. The instrument of claim 11, wherein the ablation element is adapted to project ablative energy forward.

17. The instrument of claim 11, wherein the expandable balloon member is adapted to clear a transmission pathway for radiant energy from the radiant energy ablation element to a target treatment site.

8. A cardiac ablation instrument for treatment of atrial fibrillation comprising:

a catheter adapted for disposition within a heart;

an expandable balloon member coupled to the catheter and adapted for positioning proximate to a pulmonary vein, the expandable balloon having a tear-drop shape;

an ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein; and

a reflectance sensor for positioning the ablation element relative to the pulmonary vein,

wherein the reflectance sensor is capable of sensing contact between at least a portion of the instrument and cardiac tissue.

9. A cardiac ablation instrument for treatment of atrial fibrillation comprising:

a catheter adapted for disposition within a heart;

an expandable balloon member coupled to the catheter and adapted for positioning proximate to a pulmonary vein;

an ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein; and

a reflectance sensor for positioning the ablation element,

wherein the longitudinal position of the ablation element is adjustable relative to the balloon to create a lesion of variable size such that the ablation element can be configured to form a wide circumferential lesion by positioning the element at a rear location of the balloon member and the ablation element can be configured to form a smaller diameter circumferential lesion by positioning the ablation element closer to a front portion of the balloon.

18. A cardiac ablation instrument for treatment of atrial fibrillation comprising:

a catheter adapted for disposition within a heart;

an expandable balloon member coupled to the catheter and adapted for positioning proximate to a pulmonary vein;

an ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein; and

a reflectance sensor for positioning the ablation element relative to the pulmonary vein,

wherein the ablation element further comprises beam forming optics for projecting an annular beam of light, such that the ablation element projects at least a partial ring of ablative energy of variable diameter based on its axial position within the catheter body.

19. A cardiac ablation instrument for treatment of atrial fibrillation comprising:

a catheter adapted for disposition within a heart;

an expandable balloon member coupled to the catheter and adapted for positioning proximate to a pulmonary vein;

an ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein; and

a reflectance sensor for positioning the ablation element relative to the pulmonary vein,

wherein the instrument further comprises an aiming beam generator to project a pattern of visible light coincident with a desired ablation location.

20. The instrument of claim 19, wherein the instrument further comprises at least one orientation marker that can be visualized together with the aiming beam.

21. A cardiac ablation instrument for treatment of atrial fibrillation comprising:

a catheter adapted for disposition within a heart;

an expandable balloon member coupled to the catheter and adapted for positioning proximate to a pulmonary vein;

an ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein; and

a reflectance sensor for positioning the ablation element relative to the pulmonary vein,

wherein movement of the ablation element causes a change in size or fluence of an ablative energy beam incident on a target tissue.

22. A cardiac ablation instrument for treatment of atrial fibrillation comprising:

a catheter adapted for disposition within a heart;

an expandable balloon member coupled to the catheter and having a tear drop shape such that it is adapted for positioning proximate to a pulmonary vein;

an ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein; and

a reflectance sensor for positioning the ablation element within the heart,

wherein the ablation element is capable of movement within the tear-drop shaped balloon and movement of the ablation element causes a change in size or fluence of an ablative energy beam incident on a target tissue.

23. The instrument of claim 22 wherein the instrument further comprises an aiming beam generator to project a pattern of visible light coincident with a desired ablation location.

24. The instrument of claim 22, wherein the instrument further comprises at least one orientation marker that can be visualized together with the aiming beam.

25. The instrument of claim 24, wherein the orientation marker further comprises at least one virtual orientation marker electronically generated on a display.

26. The instrument of claim 24, wherein the orientation marker comprises a ring formed on the tear-drop shaped balloon, the ring adapted to facilitate dose selection.

27. The instrument of claim 24, wherein the orientation marker comprises multiple rings formed on the tear-drop shaped balloon, the rings adapted to facilitate dose selection.

28. The instrument of claim 22, further including an illumination light source for the reflectance sensor.

29. The instrument of claim 22, wherein the ablation element serves as a radiant ablation element at high power and serves as an illumination light source for the reflectance sensor at low power.