Guided cardiac ablation catheters

• US 9,861,437 B2
• Filed: 12/15/2016
• Issued: 01/09/2018
• Est. Priority Date: 07/14/1999
• Status: Expired due to Fees

• 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:
  US15/380,637
• Publication Number:
  US 20170156793A1
• Time in Patent Office: 390 Days
• Field of Search: 606 2, 606 14- 16, 606 32, 606 41
• 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, wherein the expandable balloon has a tear-drop shape;

an ablation element slidably disposed within a lumen formed in the catheter so as position the ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein, 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; and

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

wherein the ablation element and reflectance sensor are disposed within a common jacket that is slidably disposed within the lumen of the catheter to allow independent, axial repositioning of the ablation element and the reflectance sensor within the common jacket relative to the catheter and the expandable balloon member after positioning of the instrument proximate to the target tissue site.

2. The instrument of claim 1, wherein the instrument further comprises at least one orientation marker.

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

4. The instrument of claim 2, wherein the marker is on the expandable balloon of the instrument.

5. The instrument of claim 2, wherein the marker is detectable fluoroscopically.

6. The instrument of claim 1, wherein the reflectance sensor is capable of sensing contact between at least a portion of the instrument and cardiac tissue.

7. The instrument of claim 1, wherein the reflectance sensor comprises at least one optical fiber.

8. The instrument of claim 1, wherein the reflectance sensor comprises an endoscope.

9. The instrument of claim 8, wherein the endoscope further comprises an optical field enhancing element.

10. The instrument of claim 8, wherein the endoscope has a field of view greater than about 70 degrees.

11. The instrument of claim 8, wherein the endoscope has a field of view greater than about 90 degrees.

12. 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, wherein the expandable balloon has a tear-drop shape;

an ablation element slidably disposed within a lumen formed in the catheter so as position the ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein, 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; and

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

wherein the ablation element and reflectance sensor are disposed entirely spaced apart within a common jacket that is slidably disposed within the lumen of the catheter to allow axial repositioning of the common jacket relative to the catheter and the expandable balloon member.

13. The instrument of claim 12, wherein the instrument further comprises at least one orientation marker.

14. The instrument of claim 12, wherein the reflectance sensor is capable of sensing contact between at least a portion of the instrument and cardiac tissue.

15. The instrument of claim 12, wherein the reflectance sensor comprises at least one optical fiber.

16. The instrument of claim 12, wherein the reflectance sensor comprises an endoscope.

17. The instrument of claim 16, wherein the endoscope further comprises an optical field enhancing element.

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, wherein the expandable balloon has a tear-drop shape;

an ablation element slidably disposed within a lumen formed in the catheter so as position the ablation element within the balloon member for creating at least one lesion in the vicinity of the pulmonary vein, 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; and

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

wherein the ablation element and reflectance sensor are laterally spaced apart and free of contact with one another within a common jacket that is slidably disposed within the lumen of the catheter to allow axial repositioning of the common jacket relative to the catheter and the expandable balloon member.