Less-invasive devices and methods for cardiac valve surgery

• US 20040073301A1
• Filed: 09/15/2003
• Published: 04/15/2004
• Est. Priority Date: 02/22/1993
• Status: Abandoned Application

• Current Assignee: Brian S. Donlon, Daniel C. Rosenman, John H. Stevens, Michi E. Garrison, William S. Peters
• Original Assignee: Brian S. Donlon, Daniel C. Rosenman, John H. Stevens, Michi E. Garrison, William S. Peters
• Inventors: Stevens, John H., Peters, William S., Garrison, Michi E., Rosenman, Daniel C., Donlon, Brian S.
• Application Number:
  US10/662,727
• Publication Number:
  US 20040073301A1
• Time in Patent Office: Days
• 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 17/3417 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 accessing an internal chamber of the heart through a vessel having a lumen in fluid communication with the chamber, the heart and the vessel being within a patient'"'"'s chest defined by a plurality of ribs connected to a sternum, the method comprising:

positioning an instrument into an inner lumen of the vessel through a penetration in a wall thereof, a proximal end of the instrument extending out of the patient'"'"'s chest through a percutaneous access port between two adjacent ribs; and

manipulating the proximal end of the instrument to advance a distal end of the instrument through the vessel and into the internal chamber of the heart;

wherein all manipulations of the instrument are performed outside of the patient'"'"'s chest.

2. The method of claim 1 wherein the vessel comprises an aorta and the internal chamber comprises a left ventricle, the step of manipulating comprising passing the distal end of the instrument through an aortic valve disposed in an aortic position between the aorta and the left ventricle.

3. The method of claim 2 further comprising attaching a valve prosthesis at the aortic position.

4. The method of claim 3 wherein the instrument comprises a suturing instrument, further comprising applying sutures to an annulus of the aortic valve using the suturing instrument.

5. The method of claim 3 wherein the step of attaching a valve prosthesis comprises positioning the valve prosthesis through a percutaneous access port between two adjacent ribs.

6. The method of claim 3 wherein the valve prosthesis is positioned at the aortic position using a delivery handle removably coupled to the valve prosthesis, the delivery handle being manipulated at a proximal end thereof which extends out of the patient'"'"'s chest through a percutaneous access port between two adjacent ribs.

7. The method of claim 3 further comprising positioning the valve prosthesis through a percutaneous access port in a first orientation and re-orienting the valve prosthesis within the patient'"'"'s chest into a second orientation before attachment at the aortic position.

8. The method of claim 7 wherein the step of re-orienting comprises manipulating from outside of the patient'"'"'s chest an actuator on a delivery handle releasably coupled to the valve prosthesis.

9. The method of claim 7 wherein the second orientation is approximately perpendicular to the first orientation.

10. The method of claim 1 wherein all steps are performed without cutting or removing the ribs or sternum.

11. The method of claim 1 further comprising visualizing the vessel through a visualization device positioned in a percutaneous access port between two adjacent ribs.

14. The method of claim 2 wherein the percutaneous access port is positioned in an intercostal space selected from the first, second, third, or fourth intercostal space on an anterior side of the patient'"'"'s chest.

15. The method of claim 1 wherein the percutaneous access port comprises a cannula having a proximal end outside of the patient'"'"'s chest, a distal end within th patient'"'"'s chest exterior to the vessel, and a passage therebetween through which the instrument is positioned.

12. The method of claim I further comprising forming an incision in the vessel using a cutting tool manipulated from outside of the patient'"'"'s chest.

13. The method of claim 12 further comprising retracting the incision open before positioning the instrument in the vessel lumen.

16. In a valve replacement procedure, a method of positioning a replacement valve in a patient'"'"'s heart within a patient'"'"'s chest, the chest being defined by a plurality of ribs, the method comprising:

positioning an access device in the chest between two adjacent ribs, the access device defining an opening into the chest between the ribs and having and an illuminating device mounted adjacent to the opening;

illuminating the interior of the chest with the illuminating the device; and

introducing the replacement valve into the patient'"'"'s chest through the opening.

17. In a valve replacement procedure, a method of positioning a replacement valve in a patient'"'"'s heart within a patient'"'"'s chest, the chest being defined by a plurality of ribs, the method comprising:

positioning the distal end of an illuminating device within the chest through a percutaneous access port between two adjacent ribs;

illuminating the interior of the chest with the illuminating the device; and

introducing the replacement valve into the patient'"'"'s chest through a percutaneous access port between two adjacent ribs while illuminating the interior of the chest with the illuminating device.

18. An access device for providing a percutaneous passage into a chest cavity through which a replacement cardiac valve may be positioned, the access device comprising:

a device body having proximal and distal ends, the distal end being positionable between two adjacent ribs into the chest, the device body being configured to displace tissue between the ribs so as to define an opening into the chest through which the replacement valve may be positioned without interference; and

an illumination device mounted to the device body so as to illuminate the interior of the chest.

19. An access cannula for providing a percutaneous passage into a chest cavity through which a replacement cardiac valve may be positioned the access cannula comprising:

a cannula body having proximal and distal ends, the distal end being positionable between two adjacent ribs into the chest, and having a lumen between the proximal and distal ends through which the replacement valve may be positioned into the chest; and

a light-conducting element mounted to the cannula body and extending from outside the chest to the distal end of the cannula body for illuminating the interior of the chest.

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

introducing the replacement valve into the patient'"'"'s chest through a percutaneous access port between two adjacent ribs; and

positioning the replacement valve through a penetration in the aorta and into the aortic position by manipulating a valve-positioning instrument which engages the replacement valve, wherein all manipulation of the valve-engaging instrument is performed outside of the chest.