Method and apparatus for thoracoscopic intracardiac procedures

• US 5,855,614 A
• Filed: 05/07/1996
• Issued: 01/05/1999
• Est. Priority Date: 02/22/1993
• Status: Expired due to Fees

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Roth, Alex T., Stevens, John H., Peters, William S., Reitz, Bruce A.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/646,182
• Time in Patent Office: 973 Days
• Field of Search: 606/213, 606/151, 606/215, 606/220, 606/1, 600/32, 128/898, 623/11, 623/12, 623/66, 623/2, 604/174, 604/175, 604/11, 604/13, 604/15
• US Class Current: 128/898
• 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 closing a cardiac septal defect in a patient'"'"'s heart by passing at least one instrument through a first penetration in the patient'"'"'s chest and through a second penetration in the wall of the patient'"'"'s heart, said method comprising:

forming a first penetration in the patient'"'"'s chest wall which passes into the patient'"'"'s thoracic cavity;

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

forming a second penetration in the wall of the patient'"'"'s heart which passes into a cardiac chamber of the patient'"'"'s heart;

positioning at least a distal end of the tubular access device through the second penetration and into the cardiac chamber of the heart;

passing at least one instrument through an inner lumen of the access device, and out of the distal end of the access device into the cardiac chamber in the heart; and

using the instrument to close the septal defect.

2. A method as in claim 1, wherein the septal defect is closed while the heart continues to beat.

3. A method as in claim 1, wherein the cardiac chamber is selected from the right atrium, the right ventricle, and the left atrium.

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

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

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

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

8. A method as in claim 6, further comprising percutaneously introducing a viewing scope into the working space and viewing the heart while forming the penetration in the wall of the heart 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 from a camera mounted to the viewing scope.

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

11. A method as in claim 1, further comprising forming a hemostatic seal between the access device and the muscular wall of the heart to inhibit blood loss through the penetration in the muscular wall of the heart.

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

13. A method as in claim 11, wherein the hemostatic seal is formed by radially expanding the access device.

14. A method as in claim 11, wherein the hemostatic seal is formed by tightening a purse-string suture in the muscular wall of the heart around the penetration.

15. A method as in claim 1, further comprising visualizing the interior chamber of the heart to identify the septal defect.

16. A method as in claim 15, wherein the step of visualizing is performed with an ultrasonic probe.

17. A method as in claim 16, wherein the ultrasonic probe is placed in an esophagus of the patient.

18. A method as in claim 15, wherein the step of visualizing is performed with a scope introduced through the inner lumen of the access device into the cardiac chamber.

19. A method as in claim 18, wherein the scope has a transparent bulb at its distal end, and the step of visualizing comprises positioning the transparent bulb near the defect and viewing the defect through the scope.

20. The method of claim 19, wherein the transparent bulb comprises an inflatable balloon attached to the distal end of the scope, the balloon being inflated after the scope is introduced into the chamber of the heart.

21. A method as in claim 1, wherein the cardiac septal defect is closed by positioning a patch across the defect and securing the patch to the cardiac septum.

22. A method as in claim 21 wherein the patch is collapsible for introduction through the inner lumen of the access device.

23. A method as in claim 1 wherein the patch is introduced using an elongated introducer shaft having means at its distal end for releasably holding the patch.

24. A method as in claim 2 wherein the patch is collapsed in an aperture at the distal end of the introducer shaft during introduction through the access device.

25. A method as in claim 1, 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.

26. A method as in claim 25, 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.

27. A method as in claim 1, further comprising harvesting a portion of pericardium, wherein the cardiac septal defect is closed by securing said pericardium portion to the cardiac septum across the defect.

28. A method of claim 27, further comprising securing the pericardium portion to a frame and securing the frame to the cardiac septum.

29. A method for closing a cardiac septal defect of the type in which a patch of material is secured over the defect by Passing the patch through a first penetration in the patient'"'"'s chest wall and through a second penetration in the wall of the patient'"'"'s heart, wherein the method comprises:

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

forming a second opening that passes through the wall of the heart and into an interior chamber of the heart;

providing a patch and a cardiac septal defect repair instrument, the instrument supporting the patch;

passing the patch and part of the instrument through the first opening in the chest wall and through the second opening in the wall of the heart until the patch is located within the interior chamber of the heart; and

repairing the cardiac septal defect in the patient'"'"'s heart by securing the patch over the defect.

30. A method as in claim 29, wherein the repair patch is introduced and secured while the heart is beating.

31. A method as in claim 29, wherein the ribs and sternum are maintained intact while the repair patch is introduced and secured, and further comprising using an access device percutaneously positioned through the first opening in the chest wall and an intercostal space and through the second opening in the muscular wall of the heart to introduce the patch and instrument.

32. A method as in claim 29, wherein the patch is a pericardium patch harvested from the patient'"'"'s pericardium and secured over the defect.

33. A method as in claim 32, wherein the pericardium patch is introduced and secured while the heart is beating.

34. A method as in claim 32, further comprising using an access device percutaneously introduced through the first opening in the chest wall and an intercostal space and through the second opening in the wall of the heart, wherein the ribs and sternum remain substantially intact while the pericardium patch is introduced into the interior chamber of the heart and secured over the defect by being passed through an inner lumen of the access device.

35. A method for closing a cardiac septal defect by suturing the defect using an instrument introduced through a first opening passing through a patient'"'"'s chest and through a second opening passing through a muscular wall of the patient'"'"'s heart, the method comprising:

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

forming a second opening that passes through the wall of the heart and into an interior chamber of the heart;

retracting the wall of the heart to provide access to the septum having a defect to be closed;

providing an instrument holding at least one needle carrying suture for suturing the defect closed;

passing the instrument and needle carrying suture through the first opening in the chest wall and through the second opening in the wall of the heart to a location adjacent the defect; and

manipulating the instrument to pass the needle and suture through the wall of the heart and then tensioning and securing the suture to close the septal defect.

36. A method as in claim 35, wherein the defect is sutured while the heart is beating.

37. A method as in claim 35, wherein an access device is percutaneously introduced through the first opening and an intercostal space and through the second opening into the interior chamber of the heart, and the instrument and needle are introduced through the access device, wherein the ribs and sternum remain intact while the defect is sutured.

38. A method as in claim 35, wherein the instrument is an automated suturing device provided with a plurality of needles and at least one length of suture, and the automated suturing device is passed through the first opening in the chest and the second opening in the wall of the heart.

39. A method as in claim 35, wherein the patient'"'"'s heart is stopped and the patient is placed on cardiopulmonary bypass before passing the instrument and needle through the second opening.

40. A method for thoracoscopically repairing a cardiac septal defect in a patient'"'"'s heart by passing an instrument through a first penetration in the patient'"'"'s chest wall and through a second penetration in the wall of the patient'"'"'s heart, the method comprising:

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

providing a cardiac access device having a distal end and a lumen in which is positioned an obturator with a cutting edge extendible out of the cardiac access device for penetrating tissue;

positioning the cardiac access device and the obturator through the first opening so that the distal end of the cardiac access device is located in the thoracic cavity;

contacting the cutting edge of the obturator with the wall of the heart and forming a second opening that passes through the wall of the heart and into an interior chamber of the heart;

placing the distal end of the cardiac access device within the interior chamber of the heart and removing the obturator from the lumen of the cardiac access device;

providing a cardiac septal defect repair instrument having a distal portion;

positioning the cardiac septal defect repair instrument in the lumen of the cardiac access device and placing the distal end of the instrument into the interior chamber of the heart; and

repairing the cardiac septal defect in the patient'"'"'s heart using the cardiac septal defect repair instrument.

41. The method of claim 40, further comprising the step of placing a purse-string suture in the wall of the patient'"'"'s heart prior to said step of forming the second opening in the wall of the heart, and tightening the suture upon placing the cardiac access device through the second opening.

42. The method of claim 41, wherein the method is carried out while the patient'"'"'s heart is beating, and the purse-string suture is tightened to inhibit blood leakage through the second opening.

43. The method of claim 40, further comprising the step of closing the second opening in the patient'"'"'s heart upon completion of the method.

44. The method of claim 40, wherein the second opening is closed using a device selected from the group consisting of suture appliers and endoscopic staplers.

45. 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;

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 one or more instruments are used to close the septal defect; and

forming a hemostatic seal between the access device and the muscular wall of the heart to inhibit blood loss through the penetration in the muscular wall of the heart.