Method and apparatus for thoracoscopic intracardiac procedures

• US 20040019348A1
• Filed: 05/21/2003
• Published: 01/29/2004
• Est. Priority Date: 02/22/1993
• Status: Abandoned Application

• Current Assignee: Alex T. Roth, Bruce A. Reitz, Hanson S. Gifford, John H. Stevens, William S. Peters
• Original Assignee: Alex T. Roth, Bruce A. Reitz, Hanson S. Gifford, John H. Stevens, William S. Peters
• Inventors: Stevens, John H., Roth, Alex T., Peters, William S., Gifford, Hanson S., Reitz, Bruce A.
• Application Number:
  US10/442,777
• Publication Number:
  US 20040019348A1
• Time in Patent Office: Days
• US Class Current: 606/34
• 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06061 Holders for needles or sutures, e.g. racks, stands hand-held holding instruments A61B17/0483; holders for articles A61B50/20; racks for syringes or for hypodermic or infusion needles A61M5/008
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• 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 2017/00053 Mapping
• 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 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 : Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 : Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00907 : for light
• CPC Class Codes: A61B 2017/0243 : for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• CPC Class Codes: A61B 2017/0475 : using sutures having a slip knot
• CPC Class Codes: A61B 2017/2943 : Toothed members, e.g. rack and pinion
• CPC Class Codes: A61B 2017/2946 : Locking means
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3486 : Balloon
• CPC Class Codes: A61B 2017/3492 : against the outside of the body
• CPC Class Codes: A61B 2018/00214 : Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00232 : having an irregular shape
• CPC Class Codes: A61B 2018/00261 : arranged in a line
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 2018/00363 : Epicardium
• CPC Class Codes: A61B 2018/00392 : Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 : Ablation
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• 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 2018/1465 : Deformable electrodes
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61F 2/2427 : Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2039/0279 : for introducing medical instruments into the body, e.g. endoscope, surgical tools
• CPC Class Codes: A61M 2039/0297 : at least part of it being inflatable, e.g. for anchoring, sealing or removing
• CPC Class Codes: A61M 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3355 : Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/366 : by liquid heat exchangers
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 39/0247 : Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: Y10S 623/904 : Heart

Abstract

Devices, systems, and methods are provided for accessing the interior of the heart and performing procedures therein while the heart is beating. In one embodiment, a tubular access device having an inner lumen is provided for positioning through a penetration in a muscular wall of the heart, the access device having a means for sealing within the penetration to inhibit leakage of blood through the penetration. The sealing means may comprise a balloon or flange on the access device, or a suture placed in the heart wall to gather the heart tissue against the access device. An obturator is removably positionable in the inner lumen of the access device, the obturator having a cutting means at its distal end for penetrating the muscular wall of the heart. The access device is preferably positioned through an intercostal space and through the muscular wall of the heart. Elongated instruments may be introduced through the tubular access device into an interior chamber of the heart to perform procedures such as septal defect repair and electrophysiological mapping and ablation. A method of septal defect repair includes positioning a tubular access device percutaneously through an intercostal space and through a penetration in a muscular wall of the heart, passing one or more instruments through an inner lumen of the tubular access device into an interior chamber of the heart, and using the instruments to close the septal defect. Devices and methods for closing the septal defect with either sutures or with patch-type devices are disclosed.

Claims

1. A method for accessing an interior chamber of a beating heart, said method comprising:

forming a penetration through a muscular wall of the heart into the interior chamber;

positioning a distal end of a tubular access device having an inner lumen through the penetration; and

forming a hemostatic seal between the device and the penetration to inhibit blood loss through the penetration.

2. A method as in claim 1 wherein the interior chamber is selected from a right atrium, a right ventricle, and a left atrium.

3. A method as in claim 2, wherein a proximal end of the tubular access device is open to the exterior and wherein blood flow through the inner lumen is prevented by the pressure head of blood within the inner lumen.

4. A method as in claim 3, wherein a lateral side of the patient is disposed upward to permit vertical entry of the tubular access device into the interior chamber from a lateral portion of the chest.

5. A method as in claim 1, wherein the tubular access device is introduced percutaneously through an intercostal space.

6. A method as in claim 5, wherein the tubular access device is passed percutaneously through an intercostal space selected from the second, third, fourth, fifth, sixth or seventh intercostal space.

7. A method as in claim 1, wherein a lung is collapsed to provide a working space between the ribs and the pericardium.

8. A method as in claim 7, further comprising percutaneously introducing a viewing scope into the working space and viewing the heart while forming the penetration and positioning the distal end of the access device.

9. A method as in claim 8, wherein the heart is viewed by viewing a video image obtained from a camera mounted to the viewing scope.

10. A method as in claim 8, wherein the heart is directly viewed through an optical passage in the viewing scope.

11. A method as in claim 1, wherein the hemostatic seal is formed by expanding a balloon around the access device to occlude the penetration.

12. A method as in claim 1, wherein the hemostatic seal is formed by radially expanding the access device.

13. A method as in claim 1, wherein the hemostatic seal is formed by tightening a purse-string suture in the heart wall around the penetration.

14. A method as in claim 1, further comprising performing a procedure on the heart using one or more instruments introduced through the inner lumen of the access device.

15. A method for closing a cardiac septal defect in a heart, said method comprising:

positioning a tubular access device percutaneously through an intercostal space and through a penetration in a muscular wall of the heart; and

passing one or more instruments from a proximal end of the access device, through an inner lumen of the access device, and out of a distal end of the access device into a cardiac chamber in the heart, wherein the one or more instruments are used to close the septal defect.

16. A method as in claim 15, wherein the cardiac septal defect is closed by applying at least one suture to the cardiac septum using a suturing instrument introduced into the cardiac chamber through the inner lumen of the access device.

17. A method as in claim 16, wherein the step of applying at least one suture comprises:

inserting through the defect a plurality of needles connected by at least one length of suture, the needles being inserted while in a retracted position;

repositioning the needles to a radially expanded position;

drawing the needles through the cardiac septum while in the radially expanded position to position the length of suture across the defect; and

tensioning the length of suture to close the defect.

18. An improved method for closing a cardiac septal defect of the type in which a patch of material is secured over the defect, wherein the improvement comprises introducing and securing the patch through an inner lumen of a tubular access device positioned through a muscular wall of the heart.

19. An improved method for closing a cardiac septal defect of the type in which a pericardium patch is secured over the defect, wherein the improvement comprises harvesting the pericardium patch using instruments introduced through one or more intercostal spaces, and introducing and securing the patch in the heart through an inner lumen of a tubular access device positioned through a muscular wall of the heart.

20. An improved method for closing a cardiac septal defect of the type in which the defect is sutured closed, wherein the improvement comprises suturing the defect using an instrument introduced through an inner lumen of a tubular access device positioned through a muscular wall of the heart.

21. A method of forming a lesion in heart tissue of a patient, comprising:

providing an electrophysiological ablating device comprising at least one electrode;

forming an opening in a patient'"'"'s chest, the opening passing through the chest wall and into the patient'"'"'s thoracic cavity;

passing the electrode through the opening;

postioning the electrode adjacent to heart tissue; and

ablating the heart tissue with the electrode to create a lesion in the heart tissue.

22. The method of claim 21, comprising the steps of:

forming a second opening in the wall of the patient'"'"'s heart, the second opening passing through the wall of the heart and into an interior chamber of the heart;

positioning the electrode through the second opening and within an interior chamber of the heart prior to the step of ablating the heart tissue with the electrode.

23. The method of claim 22, wherein the step of positioning the electrode within a chamber of the patient'"'"'s heart comprises the steps of:

introducing a tubular access device into the second opening, the access device having an inner lumen and a distal end;

inserting the electrophysiological ablation device through the inner lumen of the tubular access device such that the electrode extends beyond the distal end of the access device and within an interior chamber of the heart.

24. The method of claim 21, wherein the opening is formed intercostally and the electrophysiological ablation device is introduced through the intercostal space.

25. The method of claim 21, wherein the step of ablating the heart tissue is performed while the heart is beating.

26. A method of ablating cardiac tissue, comprising:

inserting an ablation device into a chamber of a patient'"'"'s heart through a penetration formed in a wall of the heart, the ablation device having a distal end adapted to transmit ablative energy;

positioning the distal end of the ablation device at a desired site within the chamber of the heart;

applying ablative energy to the cardiac tissue to form at least one lesion.

27. The method of claim 26, wherein the distal end of the ablation device is positioned adjacent an endocardial surface of the patient'"'"'s heart.

28. The method of claim 26, wherein the electrode is positioned within the left atrium of the heart, and the at least one lesion is formed on the endocardial surface of the left atrium.

29. The method of claim 26, wherein the electrode is positioned within the right atrium of the heart, and the at least one lesion is formed on the endocardial surface of the right atrium.

30. A method of forming a lesion in heart tissue of a patient, comprising:

providing an electrophysiological ablating device comprising an ablating element;

forming an opening in a patient'"'"'s chest, the opening passing through the chest wall and into the patient'"'"'s thoracic cavity;

positioning the ablating element through the opening so that the ablating element is disposed adjacent heart tissue; and

ablating the heart tissue with the ablating element to create a lesion in the heart tissue.

31. The method of claim 30, wherein the step of ablating the heart tissue comprises the step of applying radiofrequency energy to create the lesion in the heart tissue.

32. The method of claim 30, wherein the step of ablating the heart tissue comprises the step of applying microwave energy to create the lesion in the heart tissue.

33. The method of claim 30, wherein the step of ablating the heart tissue comprises the step of applying ultrasound energy to create the lesion in the heart tissue.

34. The method of claim 30, wherein the step of ablating the heart tissue comprises the step of applying laser energy to create the lesion in the heart tissue.

35. The method of claim 30, wherein the step of ablating the heart tissue comprises the step of applying direct current to create the lesion in the heart tissue.

36. The method of claim 30, wherein the step of ablating the heart tissue comprises the step of applying cyrogenic energy to create the lesion in the heart tissue.

37. The method of claim 30, comprising the steps of:

forming a second opening in the wall of the patient'"'"'s heart, the second opening passing through the wall of the heart and into an interior chamber of the heart;

positioning the ablating element through the second opening prior to the step of ablating the heart tissue with the ablating element.