Devices and methods for intracardiac procedures

Claims

What is claimed is:

1. A method of closed-chest replacement of a heart valve in a valve position in a patient's heart, the method comprising:

establishing cardiopulmonary bypass by withdrawing blood from a major vein in the patient, oxygenating the blood, and returning the blood after oxygenation to a major artery in the patient;

arresting the patient's heart;

forming a plurality of percutaneous intercostal penetrations in the patient's chest, each of the percutaneous intercostal penetrations being within an intercostal space between two adjacent ribs;

viewing the patient's heart through a scope extending through a first of said percutaneous intercostal penetrations in the patient's chest;

forming an internal penetration through a wall of the patient's heart using a cutting tool introduced through one of said percutaneous intercostal penetrations in the patient's chest;

locating a valve position in the heart;

positioning a replacement valve through one of said plurality of percutaneous intercostal penetrations in the patient's chest;

using an elongated instrument positioned in one of said percutaneous intercostal penetrations to position the replacement valve through the internal penetration into a chamber of the heart, the elongated instrument having a length sufficient to reach the valve position from outside of the patient's chest; and

securing the replacement valve in the valve position in the heart;

wherein all surgical manipulations are performed from outside of the patient's chest.

2. The method of claim 1 wherein the patient's heart is arrested by introducing an endovascular catheter into a peripheral artery, advancing the endovascular catheter transluminally from the peripheral artery into the patient's aorta, occluding the patient's aorta between the patient's coronary arteries and the patient's brachiocephalic artery with an expandable member on a distal end of the endovascular catheter, and perfusing the patient's myocardium with cardioplegic fluid.

3. The method of claim 1 wherein the heart valve comprises a mitral valve and the valve position comprises a mitral valve position.

4. The method of claim 3 wherein the chamber comprises a left atrium of the patient's heart.

5. The method of claim 1 wherein the percutaneous intercostal penetration is disposed in a right lateral portion of the patient's chest.

6. The method of claim 1 further comprising the step of removing at least a portion of the patient's heart valve using a cutting tool introduced through a one of said plurality percutaneous intercostal penetration and through the internal penetration.

7. The method of claim 1 further comprising sizing the patient's heart valve by means of a sizing instrument introduced through a one of said plurality percutaneous intercostal penetration and through the internal penetration.

8. The method of claim 1 wherein the replacement valve is positioned by means of an introducer, the introducer comprising an elongated shaft and means at a distal end of the shaft for holding the replacement valve.

9. The method of claim 1 wherein the step of fastening comprises suturing the replacement valve to an annulus at the valve position.

10. The method of claim 9 wherein the step of suturing comprises applying a plurality of sutures to an annulus at the valve position, drawing the sutures out of the patient's body through the internal penetration and through a percutaneous intercostal penetration, and applying the sutures to the replacement valve.

11. The method of claim 10 further comprising radially arranging the sutures in spaced-apart locations about an organizing ring disposed outside of the patient's body.

12. The method of claim 11 further comprising holding the sutures in tension in the organizing ring as the replacement valve is positioned in the valve position.

13. The method of claim 1 wherein the replacement valve is introduced through a cannula positioned in a percutaneous intercostal penetration, the cannula having a proximal end disposed outside of the patient and a distal end disposed within the chest.

14. The method of claim 8 wherein the replacement valve is removably mounted to a valve holder configured for introduction through said percutaneous intercostal penetration, the introducer being releasably coupled to the valve holder.

15. The method of claim 8 wherein the replacement valve is positioned through said percutaneous intercostal penetration in a first orientation and the replacement valve is secured in the valve position in a second orientation different than the first orientation, the method further comprising the step of pivoting the valve from the first orientation to the second orientation within the patient's chest.

16. The method of claim 15 wherein the first orientation is approximately perpendicular to the second orientation.

17. The method of claim 16 wherein an actuation means on the introducer is used to pivot the replacement valve from the first orientation to the second orientation.

18. The method of claim 1 wherein the replacement valve comprises a mechanical valve prosthesis having a substantially rigid annular frame and at least one movable leaflet coupled to the frame.

19. The method of claim 18 wherein the mechanical valve prosthesis comprises a bi-leaflet valve.

20. The method of claim 1 wherein the replacement valve has an outer diameter and said at least one percutaneous intercostal penetration has a width in a direction transverse to the adjacent ribs, the outer diameter being greater than the width.

21. The method of claim 13 wherein the replacement valve has an outer diameter and the cannula has an internal lumen through which the replacement valve is introduced, the internal lumen having a cross-sectional height larger than the outer diameter and a cross-sectional width smaller than the outer diameter of the replacement valve.

22. A method of closed-chest replacement of a heart valve in a valve position in a patient's heart, the method comprising:

establishing cardiopulmonary bypass by withdrawing blood from a major vein in the patient, oxygenating the blood, and returning the blood after oxygenation to a major artery in the patient;

arresting the patient's heart;

forming a plurality of percutaneous penetrations in the patient's chest, each of the percutaneous penetrations being within an intercostal space between two adjacent ribs;

placing a cannula in one of said percutaneous penetrations, the cannula having a proximal end disposed outside of the patient's chest, a distal end disposed within the chest, and a lumen therebetween;

viewing the patient's heart through a scope extending through one of said percutaneous penetrations;

forming an internal penetration in a structure selected from the heart or a great vessel connected to the heart using a cutting tool introduced through one of said percutaneous penetrations;

locating a valve position in the heart;

positioning a replacement valve through the lumen in said cannula and through the internal penetration into the valve position in the heart; and

securing the replacement valve in the valve position in the heart.

23. The method of claim 22 wherein the heart valve comprises a mitral valve and the valve position comprises a mitral valve position.

24. The method of claim 23 wherein the structure comprises a left atrial wall of the heart.

25. The method of claim 22 wherein the heart valve comprises an aortic valve and the valve position comprises an aortic valve position.

26. The method of claim 25 wherein the structure comprises a wall of an aorta connected to a left ventricle of the heart.

27. The method of claim 22 wherein the replacement valve has an outer diameter and said percutaneous penetration has a width in a direction transverse to the adjacent ribs, the outer diameter being greater than the width.

28. The method of claim 27 wherein the cannula has an internal lumen through which the replacement valve is introduced, the internal lumen having a cross-sectional height larger than the outer diameter and a cross-sectional width smaller than the outer diameter.

29. The method of claim 22 wherein the patient's heart is arrested by introducing an endovascular catheter into a peripheral artery, transluminally advancing the endovascular catheter from the peripheral artery into the patient's aorta, occluding the patient's aorta between the patient's coronary arteries and the patient's brachiocephalic artery with an expandable member on a distal end of the endovascular catheter, and perfusing the patient's myocardium with cardioplegic fluid.

30. A method of closed-chest replacement of a heart valve in a valve position in a patient's heart, the method comprising:

establishing cardiopulmonary bypass by withdrawing blood from a major vein in the patient, oxygenating the blood, and returning the blood after oxygenation to a major artery in the patient;

arresting the patient's heart;

forming a plurality of percutaneous penetrations in the patient's chest, each of the percutaneous intercostal penetrations being within an intercostal space between two adjacent ribs;

viewing the patient's heart through one of said percutaneous penetrations;

locating a valve position in the heart;

forming an internal penetration in a structure selected from the heart or a great vessel connected to the heart using a cutting tool introduced through one of said percutaneous penetrations;

positioning a replacement valve through one of said percutaneous penetrations;

using a first elongated instrument to position the replacement valve through the internal penetration into the valve position in the heart; and

securing the replacement valve in the valve position in the heart using a second elongated instrument positioned through one of the percutaneous penetrations;

wherein the first and second elongated instruments are manipulated only from outside of the patient's chest.

31. The method of claim 30 wherein the step of viewing comprises viewing the patient's heart using an endoscope positioned through one of said percutaneous penetrations.

32. The method of claim 30 wherein the heart valve comprises a mitral valve and the valve position comprises a mitral valve position.

33. The method of claim 30 wherein the heart valve comprises an aortic valve and the valve position comprises an aortic valve position.

34. The method of claim 30 wherein the patient's heart is arrested by introducing an endovascular catheter into a peripheral artery, transluminally advancing the endovascular catheter from the peripheral artery into the patient's aorta, occluding the patient's aorta between the patient's coronary arteries and the patient's brachiocephalic artery with an expandable member on a distal end of the endovascular catheter, and perfusing the patient's myocardium with cardioplegic fluid.

35. The method of claim 30 wherein the first elongated instrument comprises an introducer handle releasably coupled to the replacement valve such that the valve may be positioned through the percutaneous penetration when coupled to the introducer handle, the introducer handle having a length selected to reach the valve position from outside of the patient's chest.

36. The method of claim 30 wherein the second elongated instrument comprises a suturing instrument positionable through the percutaneous penetration and having a length selected to reach the valve position from outside of the patient's chest.

37. A method of closed-chest replacement of a heart valve in a valve position in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are intact and substantially unretracted, the method comprising the steps of:

establishing cardiopulmonary bypass by withdrawing blood from a major vein in the patient, oxygenating the blood, and returning the blood after oxygenation to a major artery in the patient;

arresting the patient's heart;

forming a plurality of percutaneous intercostal penetrations within intercostal spaces in the patient's chest, each of the percutaneous intercostal penetrations having a width smaller than the intercostal width;

viewing the patient's heart through a first of the percutaneous intercostal penetrations;

locating a valve position in the heart;

forming an internal penetration through a wall of the patient's heart using a cutting tool introduced through one of the percutaneous intercostal penetrations while viewing the heart through the first percutaneous intercostal penetration;

positioning a replacement valve through one of the percutaneous intercostal penetrations;

positioning the replacement valve through the internal penetration into a chamber of the heart; and

securing the replacement valve in the valve position in the heart while viewing the interior of the heart through the first percutaneous intercostal penetration;

wherein during each of said steps, the plurality of ribs is maintained intact and substantially unretracted.

38. A method of closed-chest replacement of a heart valve in a valve position in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the method comprising the steps of:

establishing cardiopulmonary bypass by withdrawing blood from a major vein in the patient, oxygenating the blood, and returning the blood after oxygenation to a major artery in the patient;

arresting the patient's heart by means of an aortic catheter having a distal end positioned in an ascending region of an aorta leading from the heart to a peripheral artery, and a proximal extremity extending through the aorta to the peripheral artery and out of the patient through a puncture therein;

forming a plurality of percutaneous intercostal penetrations within intercostal spaces in the patient's chest;

viewing the patient's heart through a first of the percutaneous intercostal penetrations;

locating a valve position in the heart;

forming an internal penetration through a wall of the patient's heart using a cutting tool introduced through one of the percutaneous intercostal penetrations while viewing the heart through the first percutaneous intercostal penetration;

positioning a replacement valve through one of the percutaneous intercostal penetrations;

positioning the replacement valve through the internal penetration into a chamber of the heart; and

securing the replacement valve in the valve position in the heart while viewing the interior of the heart through the first percutaneous intercostal penetration.

39. The method of claim 38 wherein the step of arresting the heart comprises occluding the ascending region of the aorta.

40. The method of claim 39 wherein the ascending region of the aorta is occluded with an occluding member on the distal end of the aortic catheter.

41. The method of claim 38 wherein the step of arresting the heart comprises delivering a cardioplegic fluid into a coronary vasculature of the heart.

42. The method of claim 41 wherein the cardioplegic fluid is delivered through a lumen in the aortic catheter into the ascending region of the aorta.

43. The method of claim 38 further comprising venting fluids from the ascending aorta through a lumen in the aortic catheter.

44. The method of claim 38 wherein the proximal extremity of the aortic catheter is positioned in a femoral artery.

45. The method of claim 38 wherein each of said steps is performed with the plurality of ribs intact and substantially unretracted.

46. A method of closed-chest replacement of a heart valve in a valve position in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space, the method comprising the steps of:

establishing cardiopulmonary bypass by withdrawing blood from a major vein in the patient, oxygenating the blood, and returning the blood after oxygenation to a major artery in the patient;

arresting the patient's heart;

forming a plurality of percutaneous intercostal penetrations within the intercostal spaces in the patient's chest;

viewing the patient's heart through a first of the percutaneous intercostal penetrations;

locating a valve position in the heart;

forming an internal penetration through a wall of the patient's heart using a cutting tool introduced through one of the percutaneous intercostal penetrations while viewing the heart through the first percutaneous intercostal penetration;

positioning a mechanical valve prosthesis through one of the percutaneous intercostal penetrations, the mechanical valve prosthesis having a rigid annular frame and a movable leaflet coupled to the annular frame;

using a first elongated instrument to position the mechanical valve prosthesis through the internal penetration into a chamber of the heart; and

securing the annular frame of the mechanical valve prosthesis to a valve annulus in the valve position in the heart using a second elongated instrument positioned through one of the percutaneous intercostal penetrations while viewing the interior of the heart through one of the percutaneous intercostal penetrations.

47. The method of claim 46 wherein, during the step of positioning the mechanical valve prosthesis through the percutaneous intercostal penetration, the adjacent ribs are separated by an intercostal width, the annular frame having an outer diameter larger than the intercostal width.

48. A method of closed-chest replacement of a heart valve in a valve position in a patient's heart, the heart being disposed within a chest cavity defined by a plurality of ribs, each rib being separated from an adjacent rib by an intercostal space having an intercostal width when the ribs are intact and substantially unretracted, the method comprising the steps of:

establishing cardiopulmonary bypass by withdrawing blood from a major vein in the patient, oxygenating the blood, and returning the blood after oxygenation to a major artery in the patient;

arresting the patient's heart;

forming a plurality of percutaneous intercostal penetrations within intercostal spaces in the patient's chest, each of the percutaneous intercostal penetrations having a width smaller than the intercostal width;

viewing the patient's heart through a first of the percutaneous intercostal penetrations;

locating a valve position in the heart;

forming an internal penetration through a wall of the patient's heart using a cutting tool introduced through one of the percutaneous intercostal penetrations while viewing the heart through the first percutaneous intercostal penetration;

positioning a replacement valve through one of the percutaneous intercostal penetrations with the replacement valve in a first orientation;

reorienting the replacement valve into a second orientation within the patient's chest;

positioning the replacement valve through the internal penetration into a chamber of the heart; and

securing the replacement valve in the valve position in the heart while viewing the interior of the heart through the first percutaneous intercostal penetration.

49. The method of claim 48 wherein the replacement valve has an annular ring for attachment to a valve annulus at the valve position in the heart, the annular ring being generally parallel to the valve annulus in the second orientation.

50. The method of claim 49 wherein the annular ring is generally perpendicular to the valve annulus in the first orientation.

51. The method of claim 48 wherein the step of reorienting comprises pivoting the replacement valve approximately 90.degree. from the first orientation to the second orientation.

FIELD OF THE INVENTION

This invention relates generally to instruments and techniques for performing less-invasive surgical procedures, and more specifically, to instruments and techniques for less-invasive surgery within the heart and great vessels.

BACKGROUND OF THE INVENTION

Various types of surgical procedures are currently performed to investigate, diagnose, and treat diseases of the heart and the great vessels of the thorax. Such procedures include repair and replacement of mitral, aortic, and other heart valves, repair of atrial and ventricular septal defects, pulmonary thrombectomy, treatment of aneurysms, electrophysiological mapping and ablation of the myocardium, and other procedures in which interventional devices are introduced into the interior of the heart or a great vessel.

Using current techniques, many of those procedures require a gross thoracotomy, usually in the form of a median sternotomy, to gain access into the patient's thoracic cavity. A saw or other cutting instrument is used to cut the sternum longitudinally, allowing two opposing halves of the anterior or ventral portion of the rib cage to be spread apart. A large opening into the thoracic cavity is thus created, through which the surgical team may directly visualize and operate upon the heart and other thoracic contents.

Surgical intervention within the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system, and arrest of cardiac function. Usually, the heart is isolated from the arterial system by introducing an external aortic cross-clamp through a sternotomy and applying it to the aorta between the brachiocephalic artery and the coronary ostia. Cardioplegic fluid is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the aortic root, so as to arrest cardiac function. In some cases, cardioplegic fluid is injected into the coronary sinus for retrograde perfusion of the myocardium. The patient is placed on cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood.

Of particular interest to the present invention are intracardiac procedures for surgical treatment of heart valves, especially the mitral and aortic valves. According to recent estimates, more than 79,000 patients are diagnosed with aortic and mitral valve disease in U.S. hospitals each year. More than 49,000 mitral valve or aortic valve replacement procedures are performed annually in the U.S., along with a significant number of heart valve repair procedures.

Various surgical techniques may be used to repair a diseased or damaged valve, including annuloplasty (contracting the valve annulus), quadrangular resection (narrowing the valve leaflets), commissurotomy (cutting the valve commissures to separate the valve leaflets), shortening mitral or tricuspid valve chordae tendonae, reattachment of severed mitral or tricuspid valve chordae tendonae or papillary muscle tissue, and decalcification of valve and annulus tissue. Alternatively, the valve may be replaced, by excising the valve leaflets or the natural valve, and securing a replacement valve in the valve position, usually by suturing the replacement valve to the natural valve annulus. Various types of replacement valves are in current use, including mechanical and biological prostheses, homografts, and allografts, as described in Bodnar and Frater, Replacement Cardiac Valves 1-357 (1991), which is incorporated herein by reference. A comprehensive discussion of heart valve diseases and the surgical treatment thereof is found in Kirklin and Barratt-Boyes, Cardiac Surgery 323-459 (1986), the complete disclosure of which is incorporated herein by reference.

The mitral valve, located between the left atrium and left ventricle of the heart, is most easily reached through the wall of the left atrium, which normally resides on the posterior side of the heart, opposite the side of the heart that is exposed by a median sternotomy. Therefore, to access the mitral valve via a sternotomy, the heart is rotated to bring the left atrium into an anterior position accessible through the sternotomy. An opening, or atriotomy, is then made in the right side of the left atrium, anterior to the right pulmonary veins. The atriotomy is retracted by means of sutures or a retraction device, exposing the mitral valve directly posterior to the atriotomy. One of the forementioned techniques may then be used to repair or replace the valve.

An alternative technique for mitral valve access may be used when a median sternotomy and/or rotational manipulation of the heart are undesirable. In this technique, a large incision is made in the right lateral side of the chest, usually in the region of the fifth intercostal space. One or more ribs may be removed from the patient, and other ribs near the incision are retracted outward to create a large opening into the thoracic cavity. The left atrium is then exposed on the posterior side of the heart, and an atriotomy is formed in the wall of the left atrium, through which the mitral valve may be accessed for repair or replacement.

Using such open-chest techniques, the large opening provided by a median sternotomy or right thoracotomy enables the surgeon to see the mitral valve directly through the left atriotomy, and to position his or her hands within the thoracic cavity in close proximity to the exterior of the heart for manipulation of surgical instruments, removal of excised tissue, and/or introduction of a replacement valve through the atriotomy for attachment within the heart. However, these invasive, open-chest procedures produce a high degree of trauma, a significant risk of complications, an extended hospital stay, and a painful recovery period for the patient. Moreover, while heart valve surgery produces beneficial results for many patients, numerous others who might benefit from such surgery are unable or unwilling to undergo the trauma and risks of current techniques.

What is needed, therefore, are devices and methods for carrying out heart valve repair and replacement as well as other procedures within the hem and great vessels that reduce the trauma, risks, recovery time and pain that accompany current techniques. The devices and methods should facilitate surgical intervention within the heart or great vessels without the need for a gross thoracotomy, preferably through small incisions within intercostal spaces of the rib cage, without cutting, removing, or significantly deflecting the patient's ribs or sternum. In particular, the devices and methods should allow for removal of tissue from the thoracic cavity, as well as for introduction of surgical instruments, visualization devices, replacement valves and the like into the thoracic cavity, to facilitate heart valve repair and replacement. Preferably, the devices and methods should facilitate replacement of a heart valve with various types of prostheses, including mechanical and biological prostheses, homografts, and allografts.

SUMMARY OF THE INVENTION

The invention provides devices and methods for performing less-invasive surgical procedures within an organ or vessel, and particularly, within the heart and great vessels of the thoracic cavity. The devices and methods of the invention facilitate intervention within the heart or great vessels without the need for a median sternotomy or other form of gross thoracotomy, substantially reducing trauma, risk of complication, recovery time, and pain for the patient. Using the devices and methods of the invention, surgical procedures may be performed through percutaneous penetrations within intercostal spaces of the patient's rib cage, without cutting, removing, or significantly displacing any of the patient's ribs or sternum. The devices and methods are particularly well-adapted for heart valve repair and replacement, facilitating visualization within the patient's thoracic cavity, repair or removal of the patient's natural valve, and, if necessary, attachment of a replacement valve in the natural valve position. The invention facilitates valve replacement with any of a variety of commercially-available replacement valves, including mechanical prostheses, bioprostheses, homografts, and allografts.

In a first preferred embodiment, the invention provides a method of closed-chest surgical intervention within an internal cavity of the patient's heart or great vessel. Utilizing the method of the invention, the patient's heart is arrested and cardiopulmonary bypass is established. An internal portion of the patient's chest is viewed by means of a scope extending through a percutaneous intercostal penetration in the patient's chest. A cutting means is introduced through a percutaneous intercostal penetration in the patient's chest, and the cutting means is used to form an internal penetration in a wall of the heart or great vessel. An interventional tool is then introduced through a percutaneous intercostal penetration and through the internal penetration in the heart or great vessel to perform a surgical procedure within the internal cavity under visualization by means of the scope. One or more percutaneous cannulae may be positioned within an intercostal space of the chest wall through which the interventional tool may be introduced into the chest cavity. The surgical procedures which may be performed within the heart or great vessel include repair or replacement of heart valves, repair of atrial and ventricular septal defects, pulmonary thrombectomy, treatment of aneurysms, electrophysiological mapping and ablation of the myocardium, myocardial drilling, correction of congenital defects, coronary artery bypass grafting, and other procedures.

The patient's heart is preferably arrested by occluding the patient's aorta between the patient's coronary arteries and the patient's brachiocephalic artery with an expandable member on a distal end of an endovascular catheter. Cardioplegic fluid is then introduced through a lumen in the catheter into the patient's aorta upstream of the expandable member to arrest cardiac function. Alternatively, or in addition to such antegrade cardioplegic fluid delivery, cardioplegic fluid may be delivered in a retrograde manner by means of a catheter positioned in the coronary sinus of the patient's heart. In an alternative approach, an external cross-clamp may be placed thoracoscopically on the aorta through a small incision or cannula in the patient's chest. Cardioplegic fluid may be delivered through either a thoracoscopically introduced cannula or an endovascular catheter extending into the ascending aorta upstream of the cross-clamp.

In a preferred embodiment, the surgical procedure comprises surgically treating a heart valve. Such surgical treatment may involve repairing the valve by introducing instruments through an intercostal penetration and through the internal penetration in the heart to perform, for example, annuloplasty, quadrangular resection of valve leaflets, commi