Less-invasive devices and methods for cardiac valve surgery

• US 6,010,531 A
• Filed: 01/31/1996
• Issued: 01/04/2000
• 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., Stevens, John H., Peters, William S., Rosenman, Daniel C., Donlon, Brian S.
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US08/594,870
• Time in Patent Office: 1,434 Days
• Field of Search: 623/1, 623/2, 623/66, 128/898, 600/201, 600/204, 604/49, 606/46
• US Class Current: 623/2.1
• 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 17/0293 with ring member to support retractor elements
• 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 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/2909 Handles
• CPC Class Codes: A61B 17/3417 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 17/3421 Cannulas
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 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 2017/00278 Transorgan operations, e.g. transgastric
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• 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 2017/00946 : malleable
• CPC Class Codes: A61B 2017/0237 : for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• 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 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/2912 : transmission of forces to actuating rod or piston
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 2017/2927 : the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2017/2932 : Transmission of forces to jaw members
• 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 2017/308 : with suction cups
• CPC Class Codes: A61B 2017/3405 : using mechanical guide means
• 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 2018/00982 : combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/306 : using optical fibres
• CPC Class Codes: A61B 90/36 : Image-producing devices or illumination devices not otherwise provided for
• 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: A61F 2007/0001 : Body part
• CPC Class Codes: A61F 2007/0054 : with a closed fluid circuit, e.g. hot water
• CPC Class Codes: A61F 2007/101 : for cooling organs in the body before or during surgery
• CPC Class Codes: A61F 7/10 : Cooling bags, e.g. ice-bags
• CPC Class Codes: A61M 1/3621 : Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3623 : Means for actively controlling temperature of blood
• CPC Class Codes: A61M 2025/028 : having a mainly rigid support structure
• CPC Class Codes: A61M 2039/027 : having a particular valve, seal or septum septum A61M2039/0036
• 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 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 623/902 : Method of implanting

Abstract

Systems and methods are disclosed for performing less-invasive surgical procedures within the heart. A method for less-invasive repair or replacement of a cardiac valve comprises placing an instrument through an intercostal access port and through a penetration in a wall of a vessel in communication with the heart, advancing the instrument into the heart, and using the instrument to perform a surgical intervention on a cardiac valve in the heart under visualization through an intercostal access port. The surgeons hands are kept outside of the chest during each step. The surgical intervention may comprise replacing the cardiac valve with a prosthetic valve, wherein the native valve is removed using a tissue removal instrument, the native valve annulus is sized with a specialized sizing device, a prosthetic valve is introduced through an intercostal access port and through the penetration in the vessel, and the prosthetic valve is secured at the native valve position, all using instruments positioned through intercostal access ports without placing the hands inside the chest. Systems and devices for performing these procedures are also disclosed.

Claims

1. A method of replacing an aortic valve of a heart within a patient'"'"'s chest, the aortic valve being disposed in an aortic position between a left ventricle of the heart and an aorta leading away from the heart, the heart being disposed in a chest defined by a plurality of ribs connected to a sternum, the method comprising:

arresting the patient'"'"'s heart;

maintaining circulation of oxygenated blood in the patient after the arresting step with a bypass system;

providing a first penetration into the patient'"'"'s chest;

incising a wall of the patient'"'"'s aorta thereby creating an opening in the patient'"'"'s aorta;

positioning an aortic valve prosthesis through the first penetration and the opening in the wall of the aorta using a first instrument, the valve prosthesis being introduced into the patient'"'"'s chest in a first orientation and re-oriented into a second orientation within the patient'"'"'s chest, the valve prosthesis is releasably coupled to a valve holder mounted to the end of a delivery handle, an actuator on the delivery handle being manipulated from outside of the patient'"'"'s chest when the valve prosthesis is re-oriented to the second orientation, the actuator being operably coupled to the valve holder for moving the valve prosthesis from the first orientation to the second orientation;

removing the patient'"'"'s native aortic valve;

creating a second penetration in the patient'"'"'s chest;

passing an occluding device through the second penetration in the patient'"'"'s chest; and

occluding the patient'"'"'s ascending aorta with the occluding device.

2. The method of claim 1 wherein the step of visualizing comprises looking directly at the aorta through the first penetration.

3. The method of claim 1 wherein the valve prosthesis is positioned at the aortic position using a delivery handle releasably coupled to the valve prosthesis, the delivery handle being manipulated from a proximal end thereof which extends out of the patient'"'"'s chest through the first penetration.

4. The method of claim 1 wherein the second orientation is approximately perpendicular to the first orientation.

5. The method of claim 1 further comprising retracting tissue adjacent to the first penetration during the step of positioning the valve prosthesis.

10. The method of claim 1 wherein the step of attaching comprises suturing the valve prosthesis to an annulus at the aortic position.

11. The method of claim 10 wherein the sutures are applied to the valve annulus by a suturing instrument extending through the first penetration and manipulated from outside the chest.

12. The method of claim 11 wherein the sutures are placed through the annulus and free ends of the suture are drawn out of the chest through the first penetration through which the valve prosthesis is positioned.

13. The method of claim 12 further comprising retaining the sutures in a suture retainer outside the chest.

15. The method of claim 12 further comprising passing the free ends of the sutures through a sewing ring of the valve prosthesis outside the chest cavity.

16. The method of claim 15 wherein the step of positioning comprises sliding the valve prosthesis along the sutures into the aortic position using a valve-engaging instrument manipulated from outside the chest.

17. The method of claim 16 further comprising tying knots in the suture outside the chest and pushing the knots through the first penetration into the chest using a knot pusher manipulated from outside the chest.

18. The method of claim 1 wherein the step of occluding is carried out with the occluding device having an external clamp.

19. The method of claim 18 wherein the external clamp is applied to the aorta using an applier manipulated from outside of the chest.

20. The method of claim 19 further comprising releasing the clamp from the applier after the clamp is applied to the aorta.

21. The method of claim 1 wherein the step of occluding is carried out with the occluding device having an expandable occluding member positioned in an ascending region of the aorta.

22. The method of claim 21 wherein the expandable occluding member is mounted on a catheter which is positioned transluminally from a peripheral artery into the ascending region of the aorta.

23. The method of claim 21 wherein the expandable occluding member is positioned into the aorta through a penetration in a wall of the aorta.

24. The method of claim 1 wherein the step of arresting the heart comprises delivering cardioplegic fluid to a myocardium of the heart.

25. The method of claim 24 wherein the cardioplegic fluid is delivered through a lumen of a catheter positioned in an ascending region of the aorta.

26. The method of claim 25 wherein the catheter is positioned transluminally from a peripheral artery into the ascending region of the aorta.

27. The method of claim 25 wherein the catheter is positioned into the ascending region of the aorta through a penetration in a wall thereof.

28. The method of claim 1 wherein the first penetration is positioned in an intercoastal space selected from the first, second, third, or fourth intercoastal space on an anterior side of the patient'"'"'s chest.

29. The method of claim 28 wherein the first penetration is positioned on a right side of the sternum.

6. A method of replacing an aortic valve of a heart within a patient'"'"'s chest, the aortic valve being disposed in an aortic position between a left ventricle of the heart and an aorta leading away from the heart, the heart being disposed in a chest defined by a plurality of ribs connected to a sternum, the method comprising:

arresting the patient'"'"'s heart;

maintaining circulation of oxygenated blood in the patient after the arresting stop with a bypass system;

providing a first penetration into the patient'"'"'s chest;

incising a wall of the patient'"'"'s aorta thereby creating an opening in the patient'"'"'s aorta;

positioning an aortic valve prosthesis through the first penetration and the opening in the wall of the aorta using a first instrument;

removing the patient'"'"'s native aortic valve;

creating a second penetration in the patient'"'"'s chest;

passing an occluding device through the second penetration in the patient'"'"'s chest;

occluding the patient'"'"'s ascending aorta with the occluding device; and

retracting tissue adjacent to the first penetration during the step of positioning the valve prosthesis, the retracting step including the step of placing a cannula through the chest wall between the two adjacent ribs, the cannula having a lumen through which the valve prosthesis may be positioned.

7. The method of claim 6 wherein the cannula has a proximal end disposed outside the chest and a distal end disposed within the chest exterior to the aorta.

8. The method of claim 7 wherein the lumen of the cannula has a central axis extending between the proximal and distal ends, and a width and a height transverse to the central axis, the height being greater than the width.

9. The method of claim 8 wherein the height of the lumen is larger than an outer diameter of the valve prosthesis and the width of the lumen is smaller than the outer diameter of the valve prosthesis.

14. A method of replacing an aortic valve of a heart within a patient'"'"'s chest, the aortic valve being disposed in an aortic position between a left ventricle of the heart and an aorta leading away from the heart the heart being disposed in a chest defined by a plurality of ribs connected to a sternum, the method comprising:

arresting the patient'"'"'s heart;

maintaining circulation of oxygenated blood in the patient after the arresting step with a bypass system;

providing a first penetration into the patient'"'"'s chest;

incising a wall of the patient'"'"'s aorta thereby creating an opening in the patient'"'"'s aorta;

positioning an aortic valve prosthesis through the first penetration and the opening in the wall of the aorta using a first instrument;

removing the patient'"'"'s native aortic valve;

creating a second penetration in the patient'"'"'s chest;

passing an occluding device through the second penetration in the patient'"'"'s chest;

occluding the patient'"'"'s ascending aorta with the occluding device;

suturing the valve prosthesis to an annulus at the aortic position, the sutures being applied to the valve annulus by a suturing instrument extending through the first penetration and manipulated from outside the chest, the sutures being placed through the annulus and free ends of the suture being drawn out of the chest through the first penetration through which the valve prosthesis is positioned; and

retaining the sutures in a suture retainer outside the chest, the suture retainer being attached to a cannula positioned between two adjacent ribs, cannula having a lumen through which the valve is positioned.

30. A method of replacing an aortic valve of a heart within a patient'"'"'s chest, the aortic valve being disposed in an aortic position between a left ventricle of the heart and an aorta leading away from the heart, the heart being disposed in a chest defined by a plurality of ribs connected to a sternum, the method comprising:

arresting the patient'"'"'s heart;

maintaining circulation of oxygenated blood in the patient after the arresting step with a bypass system;

providing a first penetration into the patient'"'"'s chest;

incising a wall of the patient'"'"'s aorta thereby creating an opening in the patient'"'"'s aorta;

positioning an aortic valve prosthesis through the first penetration and the opening in the wall of the aorta using a first instrument;

removing the patient'"'"'s native aortic valve;

creating a second penetration in the patient'"'"'s chest;

passing an occluding device through the second penetration in the patient'"'"'s chest; and

occluding the patient'"'"'s ascending aorta with the occluding device;

wherein all of the ribs and the sternum remain intact during each of the steps.