Thoracoscopic valve prosthesis delivery device

• US 5,713,951 A
• Filed: 06/05/1995
• Issued: 02/03/1998
• 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., Peters, William S.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/461,344
• Time in Patent Office: 974 Days
• Field of Search: 623/1, 623/2, 623/3, 623/66, 623/900, 606/99, 128/898
• US Class Current: 128/898
• 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 17/0218 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 17/2909 Handles
• 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 2017/0243 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 2017/2945 Curved jaws
• 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 2017/3492 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 2018/1432 : curved
• 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 2025/028 : 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 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 623/904 : 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 positioning a valve prosthesis in a patient'"'"'s chest through a penetration in a patient for implanting the valve prosthesis in the patient'"'"'s heart, the method comprising:

providing a valve prosthesis having an annular attachment ring for attaching to cardiac tissue in the heart, the attachment ring having a central axis and an outer diameter;

creating a penetration in the patient;

creating an opening in at least one of the patient'"'"'s vascular system and heart to expose a valve through the penetration and opening;

positioning the valve prosthesis through the penetration using an elongated instrument having a distal end for engaging the valve prosthesis, a proximal end held outside the chest, and a longitudinal axis, the central axis of the annular attachment ring being generally perpendicular to a longitudinal axis of the elongated instrument during the positioning step, the elongated instrument and valve prosthesis having a profile height along the central axis, the outer diameter of the attachment ring being greater than the profile height;

passing the valve prosthesis through the opening;

separating the valve from the distal end of the elongated instrument;

securing the valve prosthesis to the patient'"'"'s heart using another instrument passing through the penetration and opening; and

closing the penetration and opening.

2. The method of claim 1 wherein the elongated instrument is removably coupled to the valve prosthesis, the step of positioning comprising manipulating the elongated instrument to position the valve assembly through the penetration.

3. The method of claim 2 wherein the valve prosthesis is removably mounted to a holder, the elongated instrument being coupled to the holder, the method further comprising removing the valve prosthesis from the holder within the chest using instruments manipulated from outside the patient'"'"'s chest.

8. The method of claim 1 wherein the chest has a plurality of ribs and a sternum, the ribs and sternum being maintained intact during each of said steps.

9. The method of claim 1 wherein the percutaneous penetration is disposed in a right lateral side of the patient'"'"'s chest.

10. The method of claim 1 wherein the valve prosthesis is introduced through the penetration in a first orientation relative to the elongated instrument, the method further comprising re-orienting the valve prosthesis into a second orientation relative to the elongated instrument.

11. The method of claim 10 wherein the second orientation is generally perpendicular to the first orientation.

12. The method of claim 10 wherein, in the second orientation, a central axis of the annular attachment ring is generally parallel to a longitudinal axis of the elongated instrument.

13. The method of claim 10 wherein the valve prosthesis is held by the elongated instrument during the step of positioning, and the step of re-orienting comprises actuating an actuator at the proximal end of the elongated instrument outside of the chest, the actuator being linked to a movable coupling at the distal end of the elongated instrument which is coupled to the valve prosthesis.

14. The method of claim 1, further comprising the step of:

delivering a cardioplegic fluid to the patient'"'"'s heart thereby arresting the patient'"'"'s heart.

15. The method of claim 10 wherein the step of re-orienting comprises actuating an actuator at the proximal end of the elongated instrument, the actuator being linked to a movable coupling at the distal end of the elongated instrument which is coupled to the valve prosthesis.

16. The method of claim 14, further comprising the step of:

occluding the ascending aorta using an aortic occlusion catheter;

the delivering step being carried out by delivering the cardioplegic fluid through a lumen in the aortic occlusion catheter.

4. A method of positioning a valve prosthesis into a patient'"'"'s chest through a percutaneous penetration in an intercostal space between two adjacent ribs for implanting the valve prosthesis in the heart, the method comprising:

providing a valve prosthesis having an annular attachment ring for attaching to cardiac tissue in the heart of a patient;

creating a percutaneous penetration in an intercostal space between two adjacent ribs in the patient;

creating an opening in at least one of a patient'"'"'s vascular system and heart;

positioning the valve prosthesis through the percutaneous penetration in the patient using an elongated instrument having a distal end for engaging the valve prosthesis, a proximal end held outside the chest, and a longitudinal axis therebetween, the central axis of the annular attachment ring being in a first orientation which is generally perpendicular to the longitudinal axis during the positioning step;

passing the valve prosthesis through the opening;

separating the valve prosthesis from the elongated instrument;

securing the valve prosthesis to the patient'"'"'s hear using an instrument passing through the penetration and opening;

closing the penetration and opening; and

re-orienting the valve prosthesis into a second orientation relative to the elongated instrument within the chest after the step of positioning.

5. The method of claim 4 wherein the step of re-orienting comprises actuating an actuator at the proximal end of the elongated instrument, the actuator being linked to a movable coupling at the distal end of the elongated instrument which is coupled to the valve prosthesis.

6. The method of claim 4 wherein the second orientation is generally perpendicular to the first orientation.

7. The method of claim 4 wherein, in the second orientation, the central axis of the annular attachment ring is generally parallel to the longitudinal axis of the elongated instrument.