Devices and methods for intracardiac procedures

• US 5,571,215 A
• Filed: 12/06/1993
• Issued: 11/05/1996
• Est. Priority Date: 02/22/1993
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Garrison, Michi E., Gifford, Hanson S. III, Stevens, John H., Sterman, Wesley D.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/163,241
• Time in Patent Office: 1,065 Days
• Field of Search: 623/66, 623/1, 623/2, 623/3, 623/4, 604/49, 604/4.5, 604/280, 604/264, 604/174, 604/175, 128/898, 606/185, 606/7, 606/8
• US Class Current: 600/101
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 18/1442 Probes having pivoting end effectors, e.g. forceps
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00637 : for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 : the implement being a suture
• 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 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3427 : for intercostal space
• 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 2090/064 : for measuring force, pressure or mechanical tension
• 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: A61F 2/2496 : Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• 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 2202/047 : cardioplegic
• 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 2210/127 : Aorta
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• 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

The invention provides devices and methods for performing less-invasive surgical procedures within an organ or vessel. In an exemplary embodiment, the invention provides a method of closed-chest surgical intervention within an internal cavity of a patient'"'"'s heart or great vessel. According to the method, the patient'"'"'s heart is arrested and cardiopulmonary bypass is established. A scope extending through a percutaneous intercostal penetration in the patient'"'"'s chest is used to view an internal portion of the patient'"'"'s chest. An internal penetration is formed in a wall of the heart or great vessel using cutting means introduced through a percutaneous penetration in an intercostal space in the patient'"'"'s chest. An interventional tool is then introduced, usually through a cannula positioned in a percutaneous intercostal penetration. The interventional tool is inserted 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. In a preferred embodiment, a cutting tool is introduced into the patient'"'"'s left atrium from a right portion of the patient'"'"'s chest to remove the patient'"'"'s mitral valve. A replacement valve is then introduced through an intercostal space in the right portion of the chest and through the internal penetration in the heart, and the replacement valve is attached in the mitral valve position.

Claims

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°

from the first orientation to the second orientation.