# US 8,465,500 B2 · Thorascopic heart valve repair method and apparatus

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- Number: US 8,465,500 B2
- Document ID: US8465500B2
- Status: Granted
- Kind: B2
- Application number: 11/813,695
- Filed: 2006-01-19
- Published: 2008-08-07
- Granted: 2013-06-18
- Earliest claimed: 2005-01-21
- Assignees: Mayo Foundation for Medical Education and Research
- Applicants: Giovanni Speziali
- Inventors: Giovanni Speziali
- Web page: https://patentgrep.com/patent/US8465500B2

## CPC

- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 1/07: using light-conductive means, e.g. optical fibres
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 5/0084: {for introduction into the body, e.g. by catheters (A61B5/1459 takes precedence)}
- A61B 5/02028: {Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)}
- A61B 17/0483: {Hand-held instruments for holding sutures (A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30)}
- A61B 17/0491: {Sewing machines for surgery}
- A61B 17/06: Needles {; Sutures; Needle-suture combinations}; Holders or packages for needles or suture materials
- A61B 17/0625: {the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator (A61B17/06109 takes precedence)}
- A61B 17/29: Forceps for use in minimally invasive surgery
- A61B 1/00167: {Details of optical fibre bundles, e.g. shape or fibre distribution}
- A61B 17/295: combined with cutting implements
- A61B 2017/00057: {Light}
- A61B 2017/00243: {cardiac}
- A61B 2017/00783: {Valvuloplasty}
- A61B 2017/0608: {J-shaped}
- A61B 2090/0807: {Indication means}
- A61B 2090/306: {using optical fibres}
- G02B 23/2469: {using optical fibres}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G02B: OPTICAL ELEMENTS, SYSTEMS OR APPARATUS

## Abstract

An instrument for performing thorascopic repair of heart valves includes a shaft for extending through the chest cavity and into a heart chamber providing access to a valve needing repair. A movable tip on the shaft is operable to capture a valve leaflet and a needle is operable to penetrate a captured valve leaflet and draw the suture through the leaflet. The suture is thus fastened to the valve leaflet and the instrument is withdrawn from the heart chamber transporting the suture outside the heart chamber. The suture is anchored to the heart wall with proper tension as determined by observing valve operation with an ultrasonic imaging system.

## Claims

### Claim 1

A method of repairing a heart valve in a patient with an instrument having a distal end and a movable element, the method comprising:
inserting the instrument through the patient's chest wall and into the patient's chest cavity;
inserting the distal end and the movable element of the instrument through an exterior heart wall;
grasping a single leaflet on the heart valve between the movable element and the distal end of the instrument;
confirming capture and proper positioning of the leaflet between the movable element and the distal end using a fiber optic visualization system that detects light reflected off of the leaflet when the leaflet is properly positioned between the movable element and the distal end for proper attachment of a suture to the leaflet; wherein confirming capture and proper positioning of the leaflet between the distal end and the movable element using a fiber optic visualization system includes using a fiber optic visualization system having at least one illumination fiber optic that provides the light and at least one sensor fiber optic that conveys the reflected light from the distal end; wherein the fiber optic visualization system includes a plurality of illumination fiber optics and a plurality of sensor fiber optics, at least one illumination fiber optic and at least one sensor fiber optic positioned within each of a plurality of channels extending longitudinally through the instrument and terminating adjacent the distal end such that each channel provides an independent indication of whether the leaflet is captured between the movable element and the distal end, and wherein the step of confirming capture and proper positioning of the leaflet includes viewing each of the independent indications;
puncturing the leaflet with a needle disposed on the distal end of the instrument after confirming proper positioning of the leaflet to form a puncture opening and drawing the suture through the puncture opening to connect the suture to the leaflet;
capturing the suture with the needle;
anchoring the suture to another structure in the heart;
withdrawing the instrument through the heart wall; and
withdrawing the instrument from the chest cavity.

### Claim 2 (depends on 1)

The method of claim 1, wherein the step of anchoring the suture includes withdrawing the suture with the instrument through the heart wall and anchoring the suture to an outer surface of the heart wall.

### Claim 3 (depends on 2)

The method of claim 2, further comprising adjusting a tension on the suture before anchoring the suture by observing operation of the heart valve using a medical imaging system.

### Claim 4 (depends on 1)

The method of claim 1, further comprising placing a purse-string suture in the heart wall around a location of the instrument insertion.

### Claim 5 (depends on 1)

The method of claim 1, wherein inserting the distal end and the movable element of the instrument through the heart wall comprises inserting the distal end and the movable element of the instrument transapically.

### Claim 6 (depends on 5)

The method of claim 5, wherein the step of anchoring the suture includes withdrawing the suture with the instrument through the heart wall and anchoring the suture to an outer surface of the heart wall near the heart's apex.

### Claim 7 (depends on 1)

The method of claim 1, wherein the another structure is the heart wall.

### Claim 8 (depends on 1)

The method of claim 1, wherein the another structure is not a valve leaflet.

### Claim 9 (depends on 1)

The method of claim 1, wherein the step of inserting an instrument through the patient's chest wall comprises inserting a rigid metal shaft through the patient's chest wall.

### Claim 10

A method of confirming capture and proper positioning of a valve leaflet of a patient's heart, the method comprising:
providing an instrument having a distal end, a movable element movable with respect to the distal end, and a plurality of illuminating fibers in optical communication with a visualization monitor and an exposed surface of the distal end;
inserting the instrument through the patient's chest wall and into the patient's chest cavity;
grasping a leaflet on a heart valve between the movable element and the distal end of the instrument; and
conveying a plurality of distinct and independent colored dots to the visualization monitor corresponding to a capture status and positioning of the leaflet, wherein when the capture status of the leaflet is positive, light from the illuminating fibers is reflected off of the leaflet to the visualization monitor wherein the instrument includes a plurality of geometrically arranged illuminating fibers in optical communication with the visualization monitor and the exposed surface of the distal end, at least one illuminating fiber in each of a plurality of separate channels extending longitudinally through the instrument, each of the channels corresponding to one of the colored dots.

### Claim 11 (depends on 10)

The method of claim 10, wherein a color of each of the colored dots is substantially red when the capture status of the leaflet is negative and substantially white when the capture status of the leaflet is positive due to the light from the illuminating fibers being reflected off of the leaflet and conveyed back to the visualization monitor by one or more sensor fiber optics.

### Claim 12

A method, comprising:
providing an instrument having a distal end, a movable element and a needle disposed on the distal end; and
providing instructions for repairing a heart valve of a patient with the instrument, the instructions comprising:
inserting the instrument through the patient's chest wall and into the patient's chest cavity;
inserting the distal end and the movable element of the instrument through an exterior heart wall;
grasping a single leaflet on the heart valve between the movable element and the distal end of the instrument;
confirming capture and proper positioning of the leaflet between the movable element and the distal end using a fiber optic visualization system that detects light reflected off of the leaflet when the leaflet is properly positioned between the movable element and the distal end for proper attachment of a suture to the leaflet; wherein confirming capture and proper positioning of the leaflet between the distal end and the movable element using a fiber optic visualization system includes using a fiber optic visualization system having at least one illumination fiber that provides the light and at least one sensor fiber that conveys the reflected light from the distal end; wherein the fiber optic visualization system includes a plurality of illumination fiber optics and a plurality of sensor fiber optics, at least one illumination fiber optic and at least one sensor fiber optic positioned within each of a plurality of channels extending longitudinally through the instrument and terminating adjacent the distal end such that each channel provides an independent indication of whether the leaflet is captured between the movable element and the distal end, and wherein the step of confirming capture and proper positioning of the leaflet includes viewing each of the independent indications;
puncturing the leaflet with the needle of the instrument after confirming proper positioning of the leaflet to form a puncture opening and drawing the suture through the puncture opening to connect the suture to the leaflet;
capturing the suture with the needle;
anchoring the suture to another structure in the heart;
withdrawing the instrument through the heart wall; and
withdrawing the instrument from the chest cavity.

### Claim 13 (depends on 12)

The method of claim 12, wherein the step of anchoring the suture includes withdrawing the suture with the instrument through the heart wall and anchoring the suture to an outer surface of the heart wall.

### Claim 14 (depends on 13)

The method of claim 13, wherein the instructions further comprise adjusting a tension on the suture before anchoring the suture by observing operation of the heart valve using a medical imaging system.