Less-invasive devices and methods for treatment of cardiac valves

• US 5,972,030 A
• Filed: 10/21/1997
• Issued: 10/26/1999
• 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., Donlon, Brian S., Daniel, S. Christopher
• Primary Examiner(s): Isabella, David J.
• Application Number:
  US08/949,282
• Time in Patent Office: 735 Days
• Field of Search: 606/205, 606/206, 606/151, 606/159, 606/148, 606/150, 606/1, 623/2, 623/66
• US Class Current: 623/2.11
• 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 17/3421 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 2017/00575 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 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 : D-shaped rings
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• 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 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

Abstract

Devices and methods are provided for less-invasive surgical treatment of cardiac valves whereby the need for a gross thoracotomy or median sternotomy is eliminated. In one aspect of the invention, a delivery system for a cardiac valve prosthesis such as an annuloplasty ring or prosthetic valve includes an elongated handle configured to extend into the heart through an intercostal space from outside of the chest cavity, and a prosthesis holder attached to the handle for releasably holding a prosthesis. The prosthesis holder is attached to the handle in such a way that the holder, prosthesis and handle have a profile with a height smaller than the width of an intercostal space when the adjacent ribs are unretracted, preferably less than about 30 mm. In a further aspect, the invention provides a method for repairing or replacing a heart valve which includes the steps of introducing a prosthesis through an intercostal space and through a penetration in a wall of the heart, and securing the prosthesis to an interior wall of the heart, wherein each step is carried out without cutting, removing, or significantly retracting the ribs or sternum.

Claims

1. A system for repairing a heart valve in a patient'"'"'s heart, the system comprising:

an annuloplasty device configured for attachment within the heart around the heart valve, the annuloplasty device having an attachment portion configured to be attached to a patient'"'"'s heart, the attachment portion generally defining a plane;

a device holder configured to be releasably coupled to the annuloplasty device, the device holder having a curved outer edge and the annuloplasty device being mounted to the curved outer edge; and

an elongated handle for delivering the device holder and the annuloplasty device through an opening in a patient'"'"'s chest, the handle being attached to the device holder such that the handle, the device holder, and the annuloplasty device together have a profile with a profile height of less than 30 mm, the profile height being in a direction perpendicular to the plane defined by the attachment portion.

2. The system of claim 1 further comprising a retractor sized and configured to retract tissue around the opening in the patient to facilitate positioning the annuloplasty device therethrough.

3. The system of claim 2 wherein the retractor includes a cannula having a distal end positionable in the chest cavity through an intercostal space, a proximal end, and an inner lumen through which the annuloplasty device and the device holder may be positioned while attached to the handle.

4. The system of claim 3 wherein the inner lumen of the cannula has a cross-sectional height and a cross-sectional width, the cross-sectional height being larger than the cross-sectional width.

5. The system of claim 4 wherein the annuloplasty device has a device width in a direction perpendicular to the profile height, the cross-sectional height of the inner lumen being larger than the device width, and the cross-sectional width of the inner lumen being larger than the profile height.

6. The system of claim 5 wherein the cross-sectional height is at least about 1.5 times the cross-sectional width.

7. The system of claim 4 wherein the inner lumen has a shape selected from oval, rectangular, and trapezoidal.

8. The system of claim 3 further comprising an obturator removably positionable in the inner lumen to facilitate introduction of the cannula through the opening.

9. The system of claim 2 further comprising a suture organizer having a number of suture holders configured to retain a plurality of sutures in positions outside the patient'"'"'s chest cavity.

12. The system of claim 1 wherein the handle has a length of at least about 20 cm.

13. The method of claim 12 wherein the second vascular graft is selected from the group including a left internal mammary artery, a right internal mammary artery, a gastroepiploic artery, a radial artery, an inferior epigastric artery, a splenic artery, a saphenous vein, and a prosthetic vascular graft.

14. The system of claim 1 wherein the handle has a longitudinal axis which is at an angle of about 0°

+/-45°

relative to the plane.

15. The system of claim 1 wherein the device holder is pivotably coupled to the handle.

16. The system of claim 15 wherein the device holder is pivotable relative to the handle between a first position and a second position, the handle having a longitudinal axis which forms an angle of 0°

+/-45°

relative to the plane when in the first position, the longitudinal axis of the handle forming an angle of 90°

+/-20°

relative to the plane when in the second position.

17. The system of claim 15 wherein the handle further comprises an actuator at a proximal end thereof for pivoting the device holder.

18. The system of claim 1 wherein the device holder includes means for retaining the annuloplasty device on the device holder.

19. The system of claim 18 wherein the retention means comprises at least one suture fastened to the device holder and extending around the annuloplasty device.

20. The system of claim 19 further comprising a groove or ridge on the device holder oriented transversely to the suture for guiding a cutting edge across the suture.

21. The system of claim 18 wherein the retention means comprises a flange around a lateral edge of the device holder.

22. The system of claim 21 wherein the retention means further comprises a retaining leaf movably coupled to the device holder, the retaining leaf being movable to a closed position in opposition to the flange to form a space therebetween for receiving the annuloplasty device.

23. The method of claim 21 wherein the heart is rotated about an axis disposed at an acute angle between 0 degrees and 90 degrees relative to a longitudinal axis extending from an aortic root toward an apex of the heart.

24. The system of claim 22 wherein the retaining leaf is pivotable about an axis perpendicular to a longitudinal axis of the annuloplasty device.

25. The system of claim 22 further comprising a catch for releasably locking the retaining leaf in the closed position.

10. A system for repairing a heart valve in a patient'"'"'s heart, the system comprising:

an annuloplasty device configured for attachment within the heart around the heart valve, the annuloplasty device having an attachment portion configured to be attached to a patient'"'"'s heart, the attachment portion generally defining a plane;

a device holder releasably coupled to the annuloplasty device;

an elongated handle for delivering the device holder and the annuloplasty device through an opening in a patient'"'"'s chest, the handle being attached to the device holder such that the handle, the device holder, and the annuloplasty device together have a profile with a profile height of less than 30 mm, the profile height being in a direction perpendicular to the plane defined by the attachment portion;

a retractor sized and configured to retract tissue around the opening in the patient to facilitate positioning the annuloplasty device therethrough; and

a suture organizer having a number of suture holders configured to retain a plurality of sutures in positions outside the patient'"'"'s chest cavity;

the suture organizer being attached to the retractor.

11. A system for repairing a heart valve in a patient'"'"'s heart, the system comprising:

an annuloplasty device configured for attachment within the heart around the heart valve, the annuloplasty device having an attachment portion configured to be attached to a patient'"'"'s heart, the attachment portion generally defining a plane;

a device holder releasably coupled to the annuloplasty device;

an elongated handle for delivering the device holder and the annuloplasty device through an opening in a patient'"'"'s chest, the handle being attached to the device holder such that the handle, the device holder, and the annuloplasty device together have a profile with a profile height of less than 30 mm, the profile height being in a direction perpendicular to the plane defined by the attachment portion;

a retractor sized and configured to retract tissue around the opening in the patient to facilitate positioning the annuloplasty device therethrough; and

a suture organizer having a number of suture holders configured to retain a plurality of sutures in positions outside the patient'"'"'s chest cavity;

the retractor including a cannula having a distal end positionable in the chest cavity through the intercostal space, a proximal end, and an inner lumen, and the suture holders each include a slot disposed in a proximal end of the cannula around the inner lumen.

26. A system for repairing a heart valve in a patient'"'"'s heart, the system comprising:

an annuloplasty device configured for attachment within the heart around the heart valve, the annuloplasty device having an attachment portion configured to be attached to a patient'"'"'s heart, the annuloplasty device generally defining a plane;

a device holder releasably coupled to the annuloplasty device; and

an elongated handle for delivering the device holder and the annuloplasty device through an opening in a patient'"'"'s chest, the handle having a proximal portion, a distal portion, and a longitudinal axis, the elongate handle being coupled to the device holder;

a pivoting mechanism disposed between the handle and annuloplasty device, the pivoting mechanism permitting pivotal movement of the annuloplasty device relative to the handle in a manner which changes an angle between the plane and the longitudinal axis.

27. The system of claim 26, further comprising:

a pivoting mechanism attached to the distal portion of the handle.

28. The system of claim 26, wherein:

the annuloplasty device being pivotable relative to the handle between a first position and a second position, the handle being substantially perpendicular to the plane in the first position and being substantially parallel to the plane in the second position.

29. The system of claim 26, wherein:

the annuloplasty device, handle and holder have a profile height of less than 30 mm when the annuloplasty device is in the second position, the profile height being measured in a direction perpendicular to the plane.

30. The system of claim 26, wherein:

the device holder has a recess extending in the direction of the plane, the recess having at least one opening;

the handle having a coupling extending into the recess.