Method and apparatus for transesophageal cardiovascular procedures

• US 6,689,062 B1
• Filed: 11/22/2000
• Issued: 02/10/2004
• Est. Priority Date: 11/23/1999
• Status: Expired due to Fees

• Current Assignee: Microaccess Medical Systems, Inc.
• Original Assignee: Microaccess Medical Systems, Inc.
• Inventors: Mesallum, Sameh
• Primary Examiner(s): Ruhl, Dennis W.
• Assistant Examiner(s): Jung, William C.
• Application Number:
  US09/718,642
• Time in Patent Office: 1,175 Days
• Field of Search: 600/437-472, 606/1, 606/192, 604/96.61
• US Class Current: 600/439
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 17/3421 Cannulas
• 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 18/20 using laser
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• 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 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

A minimally invasive approach implementing the concept of transesophageal access to the heart and surrounding structures is described which allows intra and extra cardiac procedures to be performed while the heart is beating. The technique creates a short, wide and almost straight tubular access to the posterior mediastinum, pericardial space and interior of the heart through a penetration in a segment in the GI tract preferably the esophagus in proximity to a cardiac chamber. The access device isolates the penetration site from the rest of the esophageal lumen and secures the penetration site in the esophageal wall. Other means are used to secure the penetration field in the esophageal wall and prevent micro leakage, including circumferential pressure isolation of the esophageal segment, continuous intra esophageal suction and irrigation, and vacuum negative pressure throughout the procedure. The invention allows for combining transesophageal, epicardial and intracardiac ultrasound images to create stereoscopic high-resolution image for monitoring and controlling the procedure(s).

Claims

1. A method of performing a transesophageal cardiovascular procedure, said method comprising the steps of

providing an elongated tubular main access device having a first lumen with an open proximal end and a side opening distal end, and a second lumen with open ends;

passing said main access device into a patient'"'"'s esophagus so that said distal end is positioned adjacent to the esophageal wall opposite the patient'"'"'s heart while said proximal end is located outside the patient'"'"'s mouth;

forming barriers between the main access device and the esophageal wall above and below said distal end;

passing a first monitoring device through said second lumen into the patient'"'"'s esophagus to monitor the procedure;

passing an elongated flexible tubular side access unit having open proximal and distal ends and at least one lumen extending between said ends into said first lumen of the main access device until the distal end of said side access unit exits the main access device through said distal end opposite the esophageal wall;

introducing a cutting device through the lumen of the side access unit to form an opening in the esophageal wall thereby providing access to the patient'"'"'s mediastinal cavity from said lumen of the side access unit;

establishing a seal between the side access unit and the esophageal wall around said opening to inhibit fluid leakage between the esophagus and the mediastinal cavity, and

performing a procedure in said cavity using one or more surgical devices introduced through said lumen of the side access unit into said cavity.

2. The method as in claim 1 wherein the procedure comprises performing epicardial ultrasound.

3. The method as in claim 1 wherein the procedure comprises performing electrophysiological mapping from the surface of the heart.

4. The method as in claim 1 wherein the procedure comprises performing electrophysiological ablation.

5. The method as in claim 1 wherein the procedure comprises performing cardiac pacing and chronotropic driving of the heart.

6. The method as in claim 1 wherein the procedure comprises measuring surface pressure of a cardiac chamber.

7. The method as in claim 1 wherein the procedure comprises a pericardial biopsy, removing tumors or lesions from the pericardium, pericardiotomy, pericardiocentesis or a surgical procedure to cut or remove the pericardium.

8. The method as in claim 1 wherein the procedure comprises obtaining biopsy samples from paraesophageal, pulmonary, vascular or mediastinal structure.

9. The method as in claim 1 wherein the procedure comprises performing direct cannulation of a great vessel.

10. The method as in claim 1 wherein the procedure comprises manipulation of a great vessel.

11. The method as in claim 1 including the additional steps of

following the procedure, releasing the seal between the side access unit and the esophageal wall;

withdrawing the side access unit into the main access device while closing said opening;

removing the barrier between the main access device and the esophageal wall, and

withdrawing the main access device from the patient'"'"'s esophagus.

12. The method as in claim 1 including the additional steps of

providing a surgical device in the form of an elongated flexible tubular intercadiac access instrument having proximal and distal ends and at least one lumen extending between said ends;

passing said instrument into the lumen of the side access unit until the distal end of said instrument exits the distal end of the side access unit within the patient'"'"'s mediastinal cavity;

introducing a cutting device through the lumen of said instrument to form a first penetration in the pericardium thereby providing access to the pericardial space from the lumen of said instrument;

establishing a seal between said instrument and said pericardium around said first penetration, and

performing a procedure in the pericardial space using one or more surgical devices introduced through the lumen of said instrument into said space.

13. The method as in claim 12 wherein the procedure comprises performing electrophysiologic mapping from within the pericardial space.

14. The method as in claim 12 wherein the procedure comprises performing electrophysiologic ablation from within the pericardial space.

15. The method as in claim 12 wherein the procedure comprises sampling the pericardial fluid for chemical, cytological or hematological analysis.

16. The method as in claim 12 wherein the procedure comprises measuring the intracardiac pressure from the epicardium of a cardiac chamber.

17. The method as in claim 12 wherein the procedure comprises pericardial biopsy, removing a tumor, pericardiotomy, pericardiocentesis or a surgical procedure to cut or remove the pericardium.

18. The method as in claim 12 wherein the procedure comprises the insertion of a cordless sensor into the pericardial space to collect electrical, chemical, physiologic, or hemodynamic cardiac data from the pericardial space opposite a cardiac chamber.

19. The method as in claim 12 wherein the procedure comprises drug delivery into the pericardial space for acute or chronic pharmacological effect.

20. A method as in claim 12 wherein the procedure comprises delivery of stem cells or genetic material to said space for tissue regeneration including angiogenesis.

21. The method defined in claim 1 including the additional steps of

following the procedure, releasing the seal between said instrument and the pericardium;

withdrawing said instrument into the lumen of the side access unit while closing said first penetration;

releasing the seal between the side access unit and the esophageal wall;

withdrawing the side access unit into the main access device while closing said opening;

removing the barrier between the main access device and the esophageal wall, and

withdrawing the main access device from the patient'"'"'s esophagus.

22. The method defined in claim 1 including the additional steps of

providing a surgical instrument in the form of an elongated flexible tubular intercardiac access device having proximal and distal ends and at least one lumen extending between said ends;

passing said instrument into the lumen of the side access unit until the distal end of said instrument exits the distal end of said side access unit within the patient'"'"'s mediastinal cavity;

introducing a cutting device through the lumen of said instrument to form a first penetration in the patient'"'"'s pericardium opposite a cardiac chamber thereby providing access to the pericardial space from the lumen of said instrument and then, using the cutting device, forming a second penetration through the muscular wall of the cardiac chamber opposite the first penetration;

providing a seal with said instrument around the pericardium end wall to prevent blood leakage at the penetration site, and

performing a surgical procedure within the cardiac chamber using one or more surgical devices inserted into said chamber through the lumen of said instrument.

23. The method as in claim 22 herein the surgical procedure comprises repairing a septal defect in the heart.

24. The method as in claim 22 wherein the surgical procedure comprises the application of laser transmyocardial revascularization.

25. The method as in claim 22 wherein the surgical procedure comprises surgical manipulation of intracardiac natural or prosthetic valve.

26. The method as in claim 22 wherein the surgical procedure comprises intracardiac administration of a chemical, genetic, radioactive and pharmaceutical material for diagnostic or therapeutic purposes.

27. The method as in claim 22 wherein the surgical procedure comprises temporary or permanent pacing of the heart from within the cardiac chamber.

28. The method as in claim 22 wherein the surgical procedure comprises systemic or pulmonary thrombectomy.

29. The method as in claim 22 including the additional step of introducing a second monitoring device through a second lumen of said instrument to monitor the surgical procedure.

30. The method as in claim 29 wherein first and second monitoring devices in the form of signal boardering ultra sound frequencies are passed into the second lumen of the main access device of the second lumen of said instrument, respectively, each monitoring device adopted to receive the signal transmitted by the other monitoring device, and

combining the signal from both monitoring devices to provide a 3D stereoscopic real time image from two different positions in the patient.

31. The method as in claim 30 including the step of changing the relative position of said first and second transceivers during the imaging process.

32. The method as in claim 22 wherein the surgical procedure comprises coronary intravascular ultrasound, angioplasty, rotablation or atherectomy.

33. The method as in claim 22 wherein the surgical procedure comprises removing a material from the heart selected from the group consisting of thrombi, vegetations, myxomas, hypertrophy and neoplasms.

34. The method as in claim 22 wherein the surgical procedure includes passing an endoscope through a lumen on said instrument to view the interior of the cardiac chamber.